$05:Civil Money Penalty
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
In the Case of:
Golden State Manor Nursing
and Rehabilitation Center, Petitioner
- v. -
Health Care Financing Administration.
DATE: February 28, 1996
Docket No. C-94-364Decision No. CR412
DECISION
This case is before me on Petitioner's request for an
administrative law judge hearing on the determination by the Health
Care Financing Administration (HCFA) that January 31, 1994 should
be the effective date of Petitioner's participation as a Medicare
provider. I sustain HCFA's determination.
An initial Medicare survey of Petitioner was conducted on December
14-23, 1993, for purposes of determining whether Petitioner could
be certified as a Medicare provider of skilled nursing services.
As a result of this survey, HCFA informed Petitioner that
deficiencies were identified which evidenced a lack of full
compliance with the requirements of 42 C.F.R. Part 483.
On January 31, 1994, Petitioner submitted its plan of correction.
By letter dated February 23, 1994, HCFA notified Petitioner that it
was certifying Petitioner as a provider in the Medicare program,
effective January 31, 1994, the date of Petitioner's acceptable
plan of correction. HCFA Exhibit (Ex). 5. 1/
Petitioner requested, and was granted, reconsideration of HCFA's
determination of its effective date of Medicare participation.
HCFA Ex. 7. By letter dated March 25, 1994, HCFA reaffirmed its
earlier decision to certify Petitioner as of January 31, 1994.
HCFA Ex. 8. Petitioner again requested that HCFA reconsider its
determination.
By letter dated May 6, 1994, HCFA reaffirmed its decision to accept
Petitioner's agreement to participate in the Medicare program
effective January 31, 1994. HCFA Ex. 9. By letter dated May 13,
1994, Petitioner requested a hearing to contest HCFA's
determination. The case was assigned to me for a hearing and a
decision.
On December 15, 1994, I issued a Ruling on Subpoena Requests, the
purpose of which was to decide Petitioner's written requests, filed
on September 13, 1994, for the issuance of subpoenas for the
production of the surveyors' notes. In this ruling, I found
Petitioner's justification for the subpoena requests to be
inadequate and insufficient to satisfy its burden under the
regulations and applicable case precedent. Furthermore, I ruled
that the surveyors' notes are part of the deliberative process and
were protected from disclosure by the deliberative process
privilege.
On January 17-20, 1995, I conducted an in-person hearing in San
Diego, California. Because the hearing did not conclude on January
20, I continued it to March 6, 1995. On March 6-10, 1995, I
conducted the remainder of the in-person hearing in San Diego,
California. The parties filed posthearing briefs, followed by
posthearing response briefs and reply briefs.
I. Findings of Fact and Conclusions of Law 2/
1. Petitioner is a skilled nursing facility, with approximately
300 beds, located in San Diego, California. Tr. 1644.
2. The San Diego District Office of Licensing and Certification,
California Department of Health Services (DHS) is authorized to
perform surveys of skilled nursing facilities in order to make
recommendations to HCFA on whether such facilities meet the federal
requirements for participation in the Medicare program. 42 U.S.C.
1395aa(a). 3/
3. The Medicare survey of Petitioner began on December 14, 1993
(Tr. 1590-1592) and was completed on December 23, 1993 (Tr. 109).
4. Although the State surveyors found Petitioner to be in
compliance with all Level A requirements imposed by HCFA for
skilled nursing facilities, there were numerous Level B
deficiencies identified at the time of the survey. HCFA Ex. 2.
5. Title XVIII of the Social Security Act, 42 U.S.C. 1395 et
seq., commonly known as the Medicare Act, establishes a federally
subsidized health insurance
program for the elderly and disabled which is administered by the
Secretary of Health and Human Services (the Secretary).
6. The Secretary has delegated to HCFA the responsibility for
carrying out many of the duties under this program.
7. Skilled nursing facilities or other entities may participate in
the Medicare program by entering into a "provider agreement" with
the Secretary. 42 U.S.C. 1395x(u) and 1395cc.
8. The results of Medicare related surveys are used by HCFA as the
basis for its decisions regarding a facility's initial or continued
participation in the Medicare program.
9. The findings of State agencies are recommendations to HCFA,
which makes the actual determination as to whether a facility is
eligible to participate or to remain in the program. 42 C.F.R.
489.10.
10. Onsite inspections (surveys) of facilities must be conducted
without any prior notice to the facility. See 42 U.S.C.
1395i-3(g)(2)(A).
11. A skilled nursing facility is defined as an institution which
is primarily engaged in providing skilled nursing care and related
services for residents who require medical or nursing care, or
rehabilitation services for the rehabilitation of injured,
disabled, or sick persons, and is not primarily for the care and
treatment of mental diseases. 42 U.S.C. 1395i-3(a).
12. A skilled nursing facility must meet also the requirements of
42 U.S.C. 1395i-3(b), (c), and (d).
13. On December 14-23, 1993, Petitioner was surveyed on behalf of
HCFA by surveyors from DHS-San Diego. The purpose of the survey
was to determine whether Petitioner was conducting its operations
in compliance with the requirements of the Medicare program.
14. DHS-San Diego then issued to Petitioner a document captioned
"Statement of Deficiencies and Plan of Correction" (HCFA 2567),
which sets out the deficiencies identified during the survey.
15. Petitioner was found to have failed to comply with various
regulations governing a skilled nursing facility's participation in
Medicare, and these were: 42 C.F.R. 483.13(a); 483.15(h)(3);
483.20(b)(1); 483.20(b)(5); 483.20(b)(6); 483.20(c)(1);
483.20(d)(1); 483.230(d)(2)(ii); 483.20(d)(2)(iii); 483.20(d)(3);
483.25; 483.25(c)(2); 483.25(e)(2); 483.35(f)(3); 483.65(a)(1);
483.65(a)(3); 483.70(d)(1); and 483.75(l)(1).
16. On January 31, 1994, Petitioner submitted its plan of
correction to DHS. HCFA Ex. 2.
17. By letter dated February 23, 1994, HCFA notified Petitioner
that it was certifying Petitioner as a provider in the Medicare
program, effective January 31, 1994, the date of Petitioner's
acceptable plan of correction. HCFA Ex. 5.
18. On February 28, 1994, HCFA sent an amended notification letter
(changing only the designation of fiscal intermediary). HCFA Ex.
6.
19. HCFA reconsidered its determination at Petitioner's request,
but, by letter dated May 6, 1994, notified Petitioner that it found
no basis to alter its initial determination. HCFA Exs. 7, 9.
20. Petitioner requested further review of the HCFA 2567 findings,
and HCFA again reaffirmed its decision to accept Petitioner's
agreement to participate in the Medicare program effective January
31, 1994. HCFA Ex. 10.
21. The survey team that conducted the December 14-23, 1993 survey
of Petitioner consisted of Glenda Shekell, Carol Pettengill, Cindy
Cox, and Judith Chute. Tr. 85-86, 1590.
22. At the time of the December 1993 survey, Petitioner had 230
residents. Tr. 1644.
23. On December 23, 1993, the last day of the survey of
Petitioner, the survey team held an exit conference with
Petitioner's representatives. Tr. 103-104, 109.
24. Petitioner's representatives were briefed thoroughly by the
survey team on December 23, 1993. Tr. 2191.
25. Glenda Shekell is a health facility evaluator nurse with
DHS-San Diego. Tr. 79-80, 83-84.
26. Ms. Shekell has worked at DHS-San Diego since April 1988 and
estimates that she has performed 200 surveys of long-term care
facilities. Tr. 80, 81-82.
27. Ms. Shekell's primary duty until April 1994 was to conduct
licensing and certification surveys of long-term care facilities.
Tr. 81.
28. Ms. Shekell was the team leader of the survey team that
performed the survey of Petitioner on December 14-23, 1993. Tr.
84, 90.
29. At the time of the December 1993 survey, Ms. Jacqy Downing was
Ms. Shekell's supervisor. Tr. 87.
30. Cynthia Cox is a health facility evaluator nurse with DHS-San
Diego and has been at her current position since January 1990. Tr.
990.
31. Ms. Cox estimated that she has participated in approximately
150 certification surveys of skilled nursing facilities. Tr. 991.
32. Ms. Cox stated that she received training in how to conduct
surveys and write deficiencies pursuant to HCFA's regulations
regarding Medicare certification for skilled nursing facilities.
Tr. 991.
33. During Ms. Cox's third year working at DHS-San Diego, Ms.
Downing became her supervisor and was her supervisor until early
1994. Tr. 992, 993-994.
34. Martha Carrillo is a certification specialist with the
Provider Certification Unit of DHS-San Diego. Tr. 921.
35. At the request of her supervisor, Ms. Carrillo reviewed the
HCFA 2567 to check the validity and accuracy of the deficiencies,
and whether the plan of correction submitted by Petitioner was
valid. Tr. 923-924.
36. Nelson Ford is a health facility evaluator supervisor with
DHS-San Diego and has been a supervisor for three years. Tr.
1582-1583.
37. In his position as supervisor, Mr. Ford schedules surveys and
acts as a resource and consultant to survey teams when they are
conducting surveys. Tr. 1583-1584.
38. Since December 1992, one of the facilities assigned to Mr.
Ford has been Petitioner. Tr. 1585, 1592.
39. Dan Murray was employed as the hospital administrator of
Petitioner from December 1993 to September 21, 1994. Tr. 2188,
2193.
40. Mr. Murray was in the facility during the time of the December
1993 survey and spoke with the surveyors. Tr. 2191.
41. Mr. Murray prepared most of Petitioner's Plan of Correction
and submitted it to HCFA on January 31, 1994. Tr. 2190-2191.
42. Joan Allison is employed by the DHS as chief of field
operations for the southern region in the licensing and
certification program. Tr. 2735-2736.
43. DHS-San Diego is one of the offices in Ms. Allison's region.
Tr. 2736.
44. Ms. Allison participated in an internal investigation in
October and November 1993 involving the San Diego DHS office. Tr.
2738-2739, 2781.
45. Ruth Patience, who has a nursing background, has worked for
HCFA for four years as a survey and certification review
specialist. She is "responsible for assisting and overseeing and
managing the state agencies who survey and certify health care
facilities." Tr. 2436, 2437, 2439-2440.
46. Ms. Patience conducts surveys by which HCFA evaluates the
effectiveness of the state surveys and also participates in
training surveyors. Tr. 2437.
47. Ms. Patience estimated that, during her employment with HCFA,
she has participated in approximately 120 surveys of long-term care
facilities. Tr. 2437-2438.
48. Prior to working for HCFA, Ms. Patience worked as a state
surveyor for a year and a half. Tr. 2438. As a surveyor, she
surveyed about 60 long-term care facilities. Id.
Evaluation of the credibility of Jacqy Downing (pp. 35-40) 4/
49. Ms. Downing is the "assistant administrator" of Petitioner and
a "registered nurse consultant for the nursing department within
the facility." Tr. 1687.
50. Ms. Downing was recruited to work for Petitioner by Dan Murray
and began working for Petitioner on January 17, 1994. Tr.
1687-1688, 2101.
51. Prior to her employment at Petitioner, Ms. Downing worked for
approximately six years at DHS-San Diego, beginning in March 1988.
Tr. 1688, 2066.
52. At DHS-San Diego, Ms. Downing was a surveyor for two and a
half years, and was promoted to health facility evaluator
supervisor on October 1, 1990. Tr. 1688, 1691, 2067.
53. Ms. Downing participated in approximately two to three surveys
a month when she was at DHS-San Diego. Tr. 1690.
54. When she was with DHS-San Diego, Ms. Downing followed the
State Operations Manual Transmittal No. 250 (SOM 250) guidelines
after they were implemented in April 1991 and instructed her survey
team to follow these guidelines. Tr. 2130.
55. As a supervisor, Ms. Downing never referred to or used the
"Resident Assessment Instrument Training Manual and Resource Guide"
(P. Ex. 52), nor did her survey team members use this manual. Tr.
2138.
56. P. Ex. 52 had not been disseminated as of January 1994,
according to Ms. Downing. Tr. 2138.
57. Ms. Downing did not have supervisory responsibilities over the
survey team that conducted the December 1993 survey of Petitioner.
Tr. 1690, 2072, 2138.
58. Ms. Downing was not onsite at Petitioner during the survey.
59. Following the survey of Petitioner, Ms. Downing did not
participate in writing any findings for the HCFA 2567. Tr. 1698.
60. In October and November 1993, Ms. Allison and Paul Keller
participated in an internal investigation involving DHS-San Diego,
the purpose of which was to determine whether someone in that
office had altered complaint documents. Tr. 2738-2739, 2781.
61. Ms. Allison and Mr. Keller went to the San Diego district
office and interviewed the district manager, the district
administrator, all of the supervisors (including Ms. Downing), and
one of her surveyors, who allegedly falsified the documents. Tr.
2740; see also Tr. 2755-2756.
62. The investigation revealed that approximately 80 survey
documents had been altered and that the falsified documents had Ms.
Downing's name "signed as the supervisor." Tr. 2743.
63. The investigation revealed that Ms. Downing's name was the
only name signed as supervisor on all of the falsified documents.
Tr. 2743.
64. The investigation revealed that "Ms. Downing had given
specific directions to the surveyor in terms of how to prepare
these complaint documents including whiting out the information and
preparing the complaint documents in that way. And then,
subsequently, in approving and sending forward all of these
complaints as if they had, in fact, been legitimately
investigated." Tr. 2745.
65. Ms. Allison stated that no other supervisors were the focus of
the investigation. Tr. 2743.
66. DHS's audits and investigations division conducted a second
investigation, which confirmed the results of the initial
investigation. Tr. 2778-2779.
67. As a result of the investigation, DHS served both Ms. Downing
and the evaluator in December 1993 with an action to dismiss from
State service. Tr. 2746, 2756, 2759-2760.
68. Prior to a State hearing, DHS and Ms. Downing reached a
stipulated agreement, which required Ms. Downing to resign
effective January 14, 1994. HCFA Ex. 14; Tr. 2746, 2758, 2779. A
hearing did not take place. Tr. 2758. Ms. Downing resigned in
accordance with the stipulated agreement. Tr. 2779.
69. Ms. Downing left the DHS on January 7, 1994. Tr. 2071.
70. Contrary to what actually occurred, Ms. Downing testified
under oath that:
a. She had no knowledge of problems regarding
thefalsification of complaints in the office. Tr.2074.
b. She "didn't have any clear understanding of whatthe
investigation was" (Tr. 2084), had no knowledgethat the focus of
the investigation was thatcomplaint results were being reported
which had notbeen investigated, and was never informed of this
byany of the investigators. Tr. 2096.
c. She was not "personally confronted" with chargesconcerning
the investigation nor were anyallegations concerning any
impropriety brought toher attention during her interview with
theinvestigators. Tr. 2084, 2086-2087.
d. No one told her that the complaints at issueoriginated
out of her survey team. Tr. 2084.
e. The investigation did not specifically concernherself and
Ms. Chute. Tr. 2075-2076.
f. She left DHS because she "chose to retire" anddenied that
she was asked to leave DHS. Tr. 2074-2075.
g. She filed for retirement in mid-December 1993and, in the
retirement papers, had given herintention to retire in January
1994. Tr. 2079-2081.
71. I find Ms. Downing's testimony regarding the circumstances
surrounding the DHS-San Diego investigation and the reasons why she
left DHS less than forthright and, at times, not consistent with
the actual events surrounding her departure from DHS.
72. Ms. Downing's attempt to hide the true nature of the DHS
investigation that began in October 1993 greatly undermines my
confidence in her credibility.
73. I find Ms. Allison's testimony to be credible and accept it as
being a truthful and accurate account of the events in question.
74. Based on Ms. Allison's testimony and the contents of the
stipulation and settlement, I find not credible Ms. Downing's
assertions that she had already planned to retire and that she had
filed for retirement in mid-December 1993, since Ms. Downing did
not produce any documents to support her assertion.
75. Whether Ms. Downing intended to retire or not, the
circumstances of the investigation and proposed adverse action
overtook any such plans and were the actual reasons for her
departure from DHS in January 1994.
76. Ms. Downing's testimony regarding the internal investigation
and the circumstances of her resignation was less than truthful.
Her questionable credibility requires me to take a cautious
approach in ascribing weight to her other testimony on the
substantive matters of this case.
Non-Applicability of 42 C.F.R. Part 488, Subpart C -- Survey
Forms and Procedures (pp. 40-63)
77. The nursing home reform provisions of the Omnibus Budget
Reconciliation Act of 1987 (OBRA '87) set minimum statutory
standards that skilled nursing facilities (SNFs) must meet to
participate in Medicare and nursing facilities (NFs) must meet to
participate in Medicaid, provided nursing home residents with
certain rights, and established a structure for State and federal
surveys and certifications of nursing homes. 42 U.S.C.
1395i-3 and 1396r. These requirements were in effect as of October
1, 1990. Sections 4202(a) and 4214(a) of OBRA '87.
78. OBRA '87 specifies the content, procedures, and frequency of
surveys as well as survey team composition. 42 U.S.C.
1395i-3(g)(2) and 42 U.S.C. 1396r(g)(2).
79. Under OBRA '87, each state is responsible for certifying that
SNFs are in compliance with the requirements of the Act through the
use of surveys conducted pursuant to certain specified protocols.
80. Congress specified in OBRA '87 that by no later than January
1, 1990, the Secretary develop, test, and validate survey protocols
for the standard and extended surveys required by law.
81. Congress stated further that the failure of the Secretary to
carry out these mandates by January 1, 1990 shall not relieve any
state or the Secretary of the responsibility to conduct surveys
required by OBRA '87. 42 U.S.C. 1395i-3 and 1396r.
82. OBRA '87 fundamentally changed the survey and certification
process by establishing a patient-oriented system to assess the
quality of care actually furnished. See 42 U.S.C. 1395i-3(f)
and (g); 42 U.S.C. 1396r(f) and (g).
83. The legislative history regarding OBRA '87 confirms the intent
of Congress to implement major reforms in nursing home care and to
create a resident-centered, outcome-oriented survey process. See
H.R. Rep. No. 391, 100th Cong., 1st Sess., pts. 1 & 2 (1987),
reprinted in 1987 U.S. Code Cong. & Admin. News 2313-1; and H.R.
Conf. Rep. No. 495, 100th Cong., 1st Sess. (1987), reprinted in
1987 U.S. Code Cong. & Admin. News 2313-1245.
84. In July, October, and November 1987, HCFA published proposed
rules which dealt with the survey and certification process,
conditions of participation, and enforcement regulations. 52 Fed.
Reg. 24,752 (1987); 52 Fed. Reg. 38,582 (1987); 52 Fed. Reg. 44,300
(1987).
85. On June 17, 1988, HCFA, acting in accordance with a February
18, 1988 court order in Estate of Smith v. Bowen, 656 F. Supp. 1093
(D. Colo. 1987), promulgated final regulations amending the
Medicare and Medicaid survey regulations then in effect. These
final regulations were based on the proposed regulations published
in July 1987. 53 Fed. Reg. 22,850 (1988).
86. Among the new regulations promulgated were 42 C.F.R. Part 488,
Subpart C. In the preamble, HCFA acknowledged Congress' enactment
of OBRA '87 and stated, among other things, that "[a] new survey
process is required by OBRA '87, effective in 1990." 53 Fed. Reg.
at 22,853.
87. The survey procedures and guidelines in 42 C.F.R. Part 488,
Subpart C were revised by HCFA to comply with congressional
directives in OBRA '87 to develop new protocols. These protocols
were published in April 1992 as SOM 250.
88. In August 1992, HCFA published proposed regulations which
would further implement provisions of OBRA '87, as further amended
by 1988, 1989, and 1990 legislation. 57 Fed. Reg. 39,278 (1992).
89. The Federal Register preamble to the final publication of 42
C.F.R. Part 488, Subpart C, notified interested parties that (1)
this Subpart pertained to conditions of participation for long-term
care facilities that were in effect at the time of publication and
(2) HCFA was, at the time of publication, in the process of making
significant and wide-ranging changes to the existing conditions of
participation based on various amendments to the law, principally
OBRA '87. 53 Fed. Reg. 22,850-22,853 (1988).
90. At least as of August 1992, HCFA put SNFs on notice that the
interpretive guidelines and survey procedures used in federal and
state surveys were revised in April 1992. 57 Fed. Reg. at 39,283
(1992).
91. At the time of its December 1993 survey, Petitioner was bound
by the survey protocols and by the applicable regulations
pertaining to the conditions of participation found at 42 C.F.R.
483, Subpart B.
92. The survey procedures set out in 42 C.F.R. Part 488, Subpart
C do not reflect the new and expanded requirements created by OBRA
'87, including those in the areas of residents' rights, quality of
patient life, quality of care, and dietary, dental, pharmacy,
nursing, and physician services. See 42 U.S.C.
1395i-3(b)-(d); 1396r-3(b)-(d); 42 C.F.R. 483.10-483.75; 54 Fed.
Reg. 5354-5355 (1989).
93. Subpart C is inconsistent with and does not implement the OBRA
'87 revisions to the health and safety requirements that a
long-term care facility must meet to participate in the Medicare
and Medicaid programs.
94. Subpart C pertains to survey methodology and conditions of
participation which became obsolete with the implementation of the
new conditions of participation and survey processes mandated by
OBRA '87, which did not go into effect until October 1990.
95. HCFA's failure to withdraw Subpart C and to formally publish
the revised protocols in formal regulations does not elevate
outdated, obviously obsolete, survey procedures and guidelines to
a legal status which is inconsistent with congressional intent.
96. The contents of 42 C.F.R. Part 488, Subpart C were never
modified and HCFA never formally repealed or withdrew Subpart C.
97. Where an administrative regulation conflicts with a statute,
the statute controls. U.S. v. Doe, 702 F.2d 819, 823 (9th Cir.
1983).
98. A federal court ordered HCFA not to repeal Subpart C. Estate
of Smith v. Sullivan, (D. Colo. 1990). (HCFA Attachment 2 at 1,
3).
99. A federal court permitted HCFA, on an interim basis, to use
the new survey protocols. Id.
100. Any alleged non-conformity with the requirements of the
Administrative Procedure Act (APA) on HCFA's part is moot in light
of the district court's interim order.
101. HCFA has followed its regulations, procedures, and
precedents. Because Subpart C became null and void and, thus,
without any operative effect, HCFA's departure from this subsection
was justified.
102. HCFA did not violate any administrative norm by its
non-adherence to the survey procedures and guidelines contained in
Subpart C.
103. HCFA was not legally required to formally withdraw or repeal
Subpart C in order for this subsection to be rendered inoperative
by the passage of OBRA '87, the provisions of which became
effective on October 1, 1990.
SOM 250 and its operational significance (pp. 64-67)
104. The provisions of SOM 250 are not "substantive," but
"interpretive". Alcarez v. Block, 746 F.2d 593, 613 (9th Cir.
1984); American Hospital Association v. Bowen, 834 F.2d 1037, 1045
(D.C. Cir. 1987); Guadamuz v. Bowen, 859 F.2d 762, 771 (9th Cir.
1988).
105. HCFA published SOM 250 to provide guidance to state
surveyors, who are responsible for determining compliance by
long-term care facilities with federal requirements imposed by
statute and regulations.
106. SOM 250 was not intended to impose any requirements that are
not otherwise set forth in the statute or regulations (HCFA Ex. 13
at 2-137); therefore, HCFA was not required to formally publish
these instructive guidelines to state surveyors in the form of a
regulation.
107. SOM 250 must be read in connection with the statutory and
regulatory provisions regarding SNFs to determine the operative
protocols, definitions, and standards that were applicable at the
time of the survey in issue.
42 C.F.R. 489.13 (pp. 67-74)
108. The parties do not disagree that 42 C.F.R. 489.13 requires
Petitioner to be in compliance with Level A requirements on the
date of the survey.
109. The final regulations published by HCFA on February 2, 1989
(effective August 1, 1989, except where specified otherwise) made
clear that all regulatory requirements were to be enforced to the
fullest extent possible, not just the more serious Level A type of
deficiencies. 54 Fed. Reg. 5317-5318 (1989).
110. In the Federal Register preamble to the publication of the
September 1991 regulations, HCFA reiterated that long term care
facilities, including SNFs, were subject to enforcement for all
violations of requirements and that it was never intended that the
Level A and Level B designations imply a hierarchy of importance.
56 Fed. Reg. 48,827.
111. There no longer exists any distinction between Level A and
Level B requirements because every violation is considered to be
potentially sufficient to deny certification.
112. The phrase "all other requirements" contained at 42 C.F.R.
489.13 means that SNFs not only must meet all requirements
established by regulation, but that any violation of the regulatory
requirements can provide a basis to deny certification.
Transitional Hospitals Corporation -- Las Vegas, DAB CR350 (1995);
SRA, Inc. D/B/A St. Mary's Parish Dialysis Center, DAB CR341
(1992).
42 C.F.R. 488.110(j) (pp. 74-76)
113. Petitioner did not prove that it met all federal requirements
by the completion date of the survey; therefore, its certification
can only be the earlier of the date on which it met all
requirements or the date when it submitted an acceptable plan of
correction or approvable waiver request to HCFA. 42 C.F.R.
489.13.
114. Petitioner did not prove, or even allege, that it had made a
waiver request or that one was granted.
115. The only issues that are relevant to the determination of the
effective date in this proceeding relate either to the date the
deficiencies were corrected or the date HCFA accepted Petitioner's
plan of correction.
116. Section 488.110(j) provides that the state agency is to
forward HCFA 2567 to facilities within 10 days after a survey is
completed. Ten calendar days from December 23, 1993 is January 2,
1994.
117. Neither 42 C.F.R. 488.110(j), nor any other provision in
this section, contains any penalty provision for the agency's
failure to comply with this 10-day requirement.
118. There is no provision in 42 C.F.R. 489.13 to respond to
situations where HCFA delays transmittal of the form 2567 to a SNF.
119. An administrative law judge does not have the authority to
equitably split the difference or fashion a remedy based on HCFA's
noncompliance with the 10-day requirement.
120. As an administrative law judge, I do not have the authority
to find the regulations ultra vires the Act, which is what I would
have to do in order to grant Petitioner the relief it seeks.
121. I interpret the alleged 10-day "requirement" as a goal which
HCFA should strive to meet in all cases, but not as something which
should either invalidate the survey nor mandate that HCFA grant the
SNF with an earlier certification date than it was given, in cases
where this goal is not met.
Case-mix stratified sample (pp. 76-79)
122. SOM 250 contains detailed instructions and guidance to enable
surveyors to carry out "case-mix stratified sampling." HCFA Ex. 13
at P-9 - P-12.
123. The regulation set out at 42 C.F.R. 488.110(d) ("Task 2 --
Resident Sample -- Selection Methodology") refers to a random
sample.
124. Subpart C of 42 C.F.R. Part 488, which describes random
sampling, does not conform to the case-mix stratified sampling
requirement of OBRA '87 (and codified at 42 U.S.C.
1395i-3(g)(2)(A)(ii) and 1396r(g)(2)(A)(ii)).
125. The correct and appropriate sampling methodology to be used,
since the enactment of OBRA '87, is the case-mix sampling approach,
which is elaborated upon in the SOM 250.
126. The survey team members referred to the SOM 250 in selecting
resident samples. Tr. 2136.
127. The surveyors' use of a case-mix stratified sample was in
accordance with the law. Tr. 1648-1650, 1670, 2450, 2456.
Deficiencies set out in the HCFA 2567 (HCFA Ex.2) (pp. 79-183)
128. The provisions of SOM 250 are the applicable criteria to
follow in determining whether a deficiency has been established.
129. SOM 250 directs the surveyor to analyze the frequency and
severity of noncompliance with regulatory requirements and to
determine whether the facility is in compliance with an individual
requirement by assessing the frequency or severity of the alleged
violation.
130. Specifically, SOM 250 directs the surveyor to take into
account negative resident outcomes.
131. A deficiency can occur when there is evidence of
noncompliance with a regulatory requirement in 42 C.F.R. 483,
and the noncompliance has a serious negative impact on the resident
or residents, such as harm or a strong potential for harm.
F221 (Resident's right to be free from restraints) (pp. 84-90)
132. Ensuring that residents are restrained only to the extent
absolutely necessary for their medical well-being or safety was of
paramount concern to the authors of the law and the regulations.
H.R. Rep. No. 391, 100th Cong., 1st Sess., part 1, at 932 (1987);
42 C.F.R. 483.13(a).
133. The SOM 250 guidelines direct that an SNF document that the
facility has considered less restrictive alternatives to
restraints. HCFA Ex. 13 at P-76 - P-77.
134. The record contains nothing which would indicate that the
interdisciplinary team ever considered less restrictive
alternatives for resident 16.
135. The statutory and regulatory framework, the language of the
regulation, and the guidance contained in SOM 250 all support that
it is incumbent upon Petitioner to document that the restraint was
necessary for the resident's medical or safety needs.
136. Petitioner did not prove that it ever considered less
restrictive alternatives for resident 16 because the evidence HCFA
has offered is persuasive, credible and unrebutted.
137. HCFA has proven that Petitioner was in violation of the
regulatory requirement set forth at 42 C.F.R. 483.13(a) with
respect to resident 16.
138. Without adequate documentation that other less restrictive
alternatives were not available, placement of resident 16 in a vest
restraint could result in a potential negative outcome. P. Exs. 1,
27; HCFA Ex. 13 at P-76 - P-77.
F 262 (Facility must maintain a sanitary, orderly and
comfortable interior) (pp. 90-93)
139. An inadvertent typographical error occurred in the HCFA 2567
when Ms. Shekell apparently mistyped "F 262" on her lap-top
computer instead of "F 261." The computer is programmed by HCFA to
automatically display the applicable regulatory citation that
corresponds to the "F" number entered. Tr. 112-113, 115-116, 121.
140. The regulatory citation corresponding to F 261 is 42 C.F.R.
483.15(h)(2). Tr. 121; HCFA Ex. 13 at P-96 - P-97.
141. Subsection (h)(2) of 42 C.F.R. 483.15 is the most
appropriate subsection for this deficiency since the findings set
forth in the HCFA 2567 pertain to the facility's sanitary
condition. HCFA Ex. 2 at 2-3.
142. Petitioner received adequate notice of the deficiency even
considering the incorrect reference to the regulations.
143. Petitioner offered no witness who was present during the
survey who specifically contradicted the observations of Ms.
Shekell.
144. Petitioner's non-compliance with the regulatory requirements
could potentially compromise the residents' health and safety or at
least compromise their mental or psychosocial well-being.
F 272 (Facility must make a comprehensive assessment of a
resident's needs. . .) (pp. 93-107)
145. The record of resident 12 is the only resident record against
which Petitioner could adequately prepare a defense with respect to
F 272. P. Ex. 3.
146. With respect to the other residents referred to in the HCFA
2567, HCFA was unable to specifically identify them or the records
alleged to be deficient.
147. HCFA did not prove that Petitioner's treatment of other
residents, in addition to resident 12, violated 42 C.F.R.
483.20(b)(1).
148. A new minimum data set (MDS) must be completed promptly after
a resident experiences a significant change in physical or mental
condition. In no case can the MDS be done less than once every
twelve months. 42 C.F.R. 483.20(b)(4)(iv)-(v); see Tr. 138.
149. Depending on a particular response on the MDS, an "automatic
trigger" or "potential trigger" may be indicated, and such triggers
direct the staff to fill out the corresponding category on another
document called the Resident Assessment Protocol Summary (RAPS).
150. Resident 12's MDS was completed on July 30, 1993. P. Ex. 3
at 2. The relevant section of the MDS for purposes of this
deficiency is Section H, which has the heading "Mood and Behavior
Patterns". P. Ex. 3 at 3-4.
151. Resident 12 showed an indication of a potentially serious
psychological problem. P. Ex. 3 at 15 (9/15/93 psychological
report).
152. Petitioner did not conduct a new MDS in September 1993 and
left the July 1993 MDS in place, unchanged. In doing so,
Petitioner thus inaccurately represented that the July 1993 MDS
continued to reflect the current condition of resident 12 although
it did not.
153. Petitioner should have completed a new MDS after resident
12's psychological interview to reflect the change in her
psychosocial status.
154. The resident was provided weekly individual and/or group
psychotherapy by a psychologist starting September 15, 1993 through
December 22, 1993. P. Ex. 3 at 16 - 19.
155. Resident 12's desire to isolate herself was care-planned
(addressed in the plan of care) on September 1, 1993. P. Ex. 3 at
24.
156. Resident 12's suicidal ideation, as illustrated by her
expressing a desire to die on September 15, 1993, was not
care-planned until November 17, 1993. Id.
157. Petitioner delayed over two months before implementing a care
plan to address resident 12's suicidal ideation.
158. Resident 12 manifested serious problems in terms of her
psychosocial well-being, and her July 30, 1993 MDS was inaccurate
with respect to her psychosocial status as of at least September
15, 1993, or earlier, possibly September 1, 1993, which is the
first indication in the record that she wanted to isolate herself.
159. There is no evidence that Petitioner ever completed a new MDS
for resident 12.
160. Petitioner violated the requirement found at 42 C.F.R.
483.20(b)(1), with respect to resident 12.
161. Petitioner's failure to maintain an accurate assessment of
resident 12's condition as the level of her depression worsened
prevented the formulation of a timely comprehensive care plan
prepared using the protocols specified by HCFA and which
corresponded to her change in psychosocial well-being.
162. By failing to accurately document resident 12's depression in
the assessment instrument, Petitioner ignored the directives of
OBRA '87 and contravened its obligation to provide appropriate
"individualized care" of high quality to its residents.
F 289 (Review of assessments) (pp. 107-122)
163. At the time of resident 16's admission, on May 1, 1993, a
bowel and bladder assessment was done, which reflected that
resident 16 was "inc[ontinent] of b[owel] and b[ladder] and "not a
candidate for bladder and bowel retraining [secondary to]
unawareness of bodily function." P. Ex. 4 at 11.
164. On resident 16's MDS, which was completed on May 14, 1993,
Petitioner's staff assessed her as being incontinent of bowel and
bladder. P. Ex. 4 at 3.
165. In the November 5, 1993 quarterly assessment, Petitioner
failed to reflect accurately resident 16's bladder continence
status, in violation of 42 C.F.R. 483.20(b)(5).
166. From November 30, 1993 through December 2, 1993, resident 16
underwent a "3-day evaluation for baseline data -- bladder
training". P. Ex. 4 at 12.
167. The result of the 3-day evaluation was that resident 16 was
assessed to be continent. P. Ex. 4 at 34 (duplicated at P. Ex. 4
at 13).
168. Petitioner failed to complete a new MDS and simply left in
place the MDS completed on May 14, 1993, which assessed resident 16
as being incontinent of bladder (and bowel).
169. By not updating the MDS, Petitioner plainly violated 42
C.F.R. 483.20(b)(5), which required Petitioner, as appropriate,
to revise resident 16's assessment to assure its continued
accuracy.
170. Resident 16 was not incontinent during December 1993.
171. By ignoring its obligation to comply with 42 C.F.R.
483.20(b)(5), Petitioner was essentially representing that between
May 1993 and the time of the survey (December 1993), resident 16
had not undergone any changes at all with respect to her continence
status and remained totally incontinent.
172. Failure to have an accurate assessment of resident 16's
continence prevented this resident from attaining her highest
practicable level of physical, mental, and psychosocial well-being
and potentially could have compromised her health and safety, since
she could have been exposed to infection if continence had not been
maintained.
173. HCFA's allegation in the HCFA 2567 that resident 16's care
plan was not updated to reflect her actual status is extraneous to
42 C.F.R. 483.20(b)(5), and I did not consider it.
174. The part of the deficiency, as set forth in the HCFA 2567,
which alleges that there was no routine individualized toileting
schedule developed to meet resident 16's needs (HCFA Ex. 2 at 5) is
extraneous to 42 C.F.R. 483.20(b)(5), and I did not consider it.
175. HCFA did not prove that resident 12's October 27, 1993
quarterly review is inaccurate.
176. Resident 12's July 30, 1993 MDS is inaccurate and there is no
evidence in the record that Petitioner ever completed a new MDS for
resident 12. FFCL 152, 159.
177. Petitioner violated 42 C.F.R. 483.20(b)(5) with respect to
resident 12.
178. The August 23, 1993 quarterly review, which indicated that
resident G.B. had no mood problems in the last seven days, is
accurate. P. Ex. 9
179. Petitioner inaccurately assessed resident G.B.'s mood
problems in the quarterly reviews dated May 28, 1993 and December
1, 1993.
180. Petitioner failed to complete a new MDS for resident G.B. in
December 1993, when G.B. began to refuse treatment, a significant
change in behavior.
181. Petitioner violated 42 C.F.R. 483.20(b)(5) with respect to
resident G.B.
F 290 (resident's comprehensive care plan) (pp. 123-125)
182. Resident 16's care plans, dated May 1, 1993 and November 7,
1993, were inaccurate because they failed to mention resident 16's
improvement in bladder condition from incontinency to continence.
183. Petitioner violated 42 C.F.R. 483.20(b)(6) by failing to
revise resident 16's care plan once she was assessed by
Petitioner's staff to be continent.
184. Petitioner's failure to revise resident 16's care plan had
the potential to cause a negative outcome for this resident.
F 292 (Each assessment must be conducted or coordinated with the
appropriate participation of health professionals) (pp. 125-128)
185. The rehabilitation screen is part of the assessment process,
but is not part of the assessment instrument.
186. After completing resident 13's rehabilitation screen, the
physical therapist should have participated also in formulating the
body control problems section of resident 13's MDS.
187. Although a licensed vocational nurse (LVN) completed the body
control problems section on resident 13's MDS, she was not the
appropriate health professional to complete this section.
188. Petitioner's failure to involve a physical therapist in the
completion of the MDS did not negatively impact resident 13.
189. The omission of contractures on the MDS did not adversely
impact the completion of the other sections. P. Ex. 20 at 4.
190. There is no evidence that resident 13 suffered any harm or
that a potential for harm existed.
191. Petitioner did not violate 42 C.F.R. 483.20(c)(1).
F 295 (Comprehensive care plans) (pp. 128-141)
192. Petitioner failed in February 1993 to contemporaneously
care-plan the physician's February 11, 1993 order that resident 1
could have her own medications at bedside, in violation of 42
C.F.R. 483.20(d)(1).
193. The record contains only a December 2, 1993 care plan
relating to self-medication. P. Ex. 21 at 30.
194. Resident 1's medical chart contains two assessment forms
titled "Self-Administration of Medication Assessment," dated April
1, 1993 and December 2, 1993. P. Ex. 21 at 26-27.
195. According to the April 1, 1993 assessment, which was signed
by a licensed nurse and a physician, resident 1 was evaluated as
not being mentally or physically able to self-administer
medication. P. Ex. 21 at 27.
196. According to the December 2, 1993 assessment, which was
signed also by a licensed nurse and a physician, resident 1 was
found to be a candidate for safe self-administration of
medications. P. Ex. 21 at 26.
197. Whether it was the February 11, 1993 physician order or the
December 2, 1993 assessment that triggered the 12/2/93 care plan,
once Petitioner was aware of the February 11, 1993 order, it should
have initiated a care plan consistent with such order. This was
not done.
198. There were instances in December 1993 when resident 1 refused
to allow Petitioner's staff to monitor her self-administration of
her medications. P. Ex. 21 at 31-34.
199. Such refusals on the part of resident 1 were not minor or
inconsequential.
200. Resident 1's actions of non-compliance directly conflicted
with the December 2, 1993 care plan approaches.
201. Once it was ascertained that the December 2, 1993 care plan
approaches could not be carried out successfully due to resident
1's refusals and her own physical condition, Petitioner should have
developed a new care plan which addressed fully resident 1's
current needs.
202. There is no evidence of a care plan that mentions the
problems of resident 1's refusals and her physical inability to
self-administer medicines or addresses how to adequately monitor
her taking of medications in light of these problems and
difficulties.
203. Petitioner's failure to develop a new care plan on these
grounds establishes further that it violated 42 C.F.R.
483.20(d)(1). FFCL 202.
204. The Social Services notes (see P. Ex. 21 at 17-19) state that
the resident exhibited yelling and screaming on October 4, 1993,
October 8, 1993, and November 15, 1993, and manifested confusion on
October 8, 1993 (P. Ex. 21 at 18).
205. Resident 1's November 30, 1993 quarterly review was
inaccurate in its assessment that resident 1 had no mood or
behavior problems. P. Ex. 21 at 7-8, 17-19.
206. Resident 1's mood and behavior problems should have been
reflected in the December 2, 1993 care plan, and Petitioner's
failure to do so constitutes a further violation of 42 C.F.R.
483.20(d)(1).
207. By leaving a misleading and inaccurate care plan in place,
thereby representing it to be accurate and up-to-date, Petitioner
potentially could have jeopardized resident 1's health, safety, and
well-being.
F 297 (A resident's care plan must be prepared by an
interdisciplinary team) (pp. 141-143)
208. There is nothing in the findings with respect to
F 297 that identifies Petitioner's conduct in contravention of the
requirements of 42 C.F.R. 483.20(d)(2)(ii), which are limited to
a resident's care plan.
209. The evidence offered by HCFA in the HCFA 2567 relating to
Resident 1's assessments is extraneous and goes beyond the
regulation at issue.
210. The deficiency, as set forth in the HCFA 2567, fails to state
with sufficient particularity the care plan in issue, the make-up
of the interdisciplinary team who prepared such care plan, and how
that grouping was in violation of the cited regulation.
211. Petitioner did not violate 42 C.F.R. 483.20(d)(2)(ii).
F 298 (comprehensive care plan must be periodically reviewed and
revised after each assessment) (pp. 143-150)
212. At the time of the surveyor's observation, resident 20 was
using a postural seating system which had been instituted pursuant
to a physician's order dated September 28, 1993, which is noted in
the care plan also. P. Ex. 23 at 4, 12.
213. Although the care plan does not specify the type of seating
system used on resident 20, the seating system which was in place
for resident 20 at the time of Ms. Cox's observation was a Linard
seating system. Tr. 1308.
214. The scenario involving resident 20 occurred as Ms. Cox
described it.
215. Petitioner presented no testimony from anyone on its staff
who was present at the time of Ms. Cox's observation of resident 20
to contradict her testimony.
216. Petitioner's staff changed resident 20's seating system. The
staff placed resident 20 in a "saddle type of thing" and replaced
his chair to alleviate his discomfort and help him sit upright.
Tr. 1062, 1308, 1310.
217. The changes made by Petitioner's staff were significant and
constituted more than a simple re-adjustment of resident 20's
existing seating system. As such, Petitioner's staff was required
to update resident 20's care plan contemporaneously to reflect this
change. FFCL 216.
218. By its failure to revise resident 20's care plan,
Petitioner did not comply with 42 C.F.R. 483.20(d)(2)(iii).
219. The existence of the 4/12/94 entry in resident 1's care plan
indicating the addition of a "western saddle" (P. Ex. 23 at 12)
does not disprove Ms. Cox's testimony that a saddle was provided to
resident 20 at the time of the survey in December 1993.
220. Petitioner's representation in its plan of correction that
resident 20's care plan had been updated to reflect the change is
uncorroborated by the record before me.
221. While there is no evidence of actual harm
to resident 20's health or safety, I find that there existed the
potential of harm to resident 20.
F 300 (Services provided by the facility must be provided by
qualified persons in accordance with each resident's care plan)
(pp. 150-158)
222. Petitioner does not dispute the facts relating to resident
24's E-Z boot as cited in the deficiency, which were based on Ms.
Cox's observations. P. Resp. Br. at 24.
223. HCFA did not offer in evidence a plan of care which
implements the physician's order requiring use of the E-Z boot.
224. While Ms. Cox could not recall at the hearing what the plan
of care said about application of the E-Z boot, she did testify
that she reviewed the care plan in connection with preparation of
this deficiency. Tr. 1069-1070.
225. Besides Ms. Cox's testimony, my review of this resident's
records, including the minimum data set, quarterly review,
rehabilitation screen and physician's order, leads me to conclude
that a care plan was developed for this resident which carried out
the physician's order for application of the E-Z boot. P. Ex. 24.
226. Even without having the care plan in evidence, there is
sufficient evidence to create a strong inference that such plan
existed and was relied on by Ms. Cox in preparing this deficiency.
227. Petitioner had the burden to come forward with evidence
proving that the care plan did not cover the E-Z boot. This
Petitioner failed to do.
228. Based on the record as a whole, I find that Petitioner failed
to carry out the physician's order in accordance with the
resident's care plan.
229. Petitioner failed to prove that the deficiency was corrected
prior to completion of the survey.
230. From December 10 through December 21, 1993, the E-Z boot was
either missing or unavailable. P. Ex. 24 at 12. Petitioner's
staff did nothing to locate the missing boot or take steps to get
a new boot. Tr. 1069-1070; P. Ex. 24 at 11, 12.
231. Petitioner's failure to have a monitoring system in place
contributed to its failure to locate the E-Z boot until the
surveyor directed the attention of the staff to its absence.
232. Petitioner did not prove, or even allege, that a monitoring
system was in place or put in place at the time of the completion
of the survey.
233. This deficiency was not corrected at the completion of the
survey.
23: The lack of a monitoring system placed resident 24 and other
residents at risk that their treatment would not be provided as
ordered by their physicians and implemented in their care plans.
235. Resident 8's care plan specifically provided that his fluid
intake would be at least 1700 cc's of fluid over a 24-hour period.
P. Ex. 25 at 5.
236. The care plan mandates that 1700 cc's was the minimum amount
of fluid that this resident was to be provided within a 24-hour
period.
237. During the period December 2 - 19, 1993, resident 8 met the
objective only on December 2 and 17, 1993. P. Ex. 25 at 2-4.
238. Petitioner failed to have this resident meet the 1700 cc
daily objective called for in the care plan. P. Ex. 25 at 2-4.
239. Petitioner's staff monitored the resident's fluid intake and
output. P. Br. at 92.
240. Monitoring resident 8's fluid intake and output and
encouraging increased intake was not a substitute for following the
specific intake objective contained in the plan of care.
241. Petitioner failed to treat resident 8 in accordance with his
written plan of care and thereby violated 42 C.F.R.
483.20(d)(3)(ii).
242. Reduction of this resident's fluid intake below the care plan
objective might have placed him at risk for pneumonia and skin
breakdown. Tr. 1078; 2588-2589.
F 309 (Necessary care and services to attain or maintain the
highest practicable physical, mental, and psychosocial well-being,
in accordance with the comprehensive assessment and care plan) (pp.
158-164)
243. Resident 20's weight upon his admission to the facility on
March 30, 1993 was 108.4 pounds. P. Ex. 26 at 10.
244. Resident 20 had, among other conditions, Parkinson's disease
and difficulty in swallowing (dysphagia). P. Ex. 26 at 1, 10.
245. Resident 20 continued to lose weight during his stay at
Petitioner. P. Ex. 26.
246. The record as a whole reflects that resident 20 was
attempting to eat his meals independently but was unable to do so
and was unable to consume sufficient nourishment with the
assistance that was being provided by Petitioner. P. Ex. 26; Tr.
233-236.
247. The only methods attempted by Petitioner to assist resident
20 were providing him with a special spoon and offering him
additional nourishment.
248. The record reflects that both of these methods were
ineffective, as resident 20 was observed as not being able to eat
independently and was not amenable to accepting the additional
nourishment offered by Petitioner.
249. Petitioner could have tried other methods, short of tube
feeding or force feeding, to attempt to enable resident 20 to eat
more, but Petitioner failed to do so.
250. There is no evidence in the record that resident 20 was ever
reassessed or that his care plan was adjusted in light of the
difficulties he was having in consuming sufficient nourishment. P.
Ex. 26.
251. Petitioner failed to provide resident 20 with the care
necessary to maintain or attain his highest practicable well-being,
in violation of 42 C.F.R. 483.25.
252. Resident 16 began the RNA ambulation program on June 15,
1993, and the initial program was for her to ambulate with a front
wheel walker 20 feet to 60 feet with the assistance of two persons,
as tolerated, seven times a week. P. Ex. 27 at 13-14; Tr.
1091-1092.
253. Resident 16 was ambulating from 60 to 100 feet during the
period June 15 - June 30, 1993, and from 80 to 100 feet during the
period July 1 - July 31, 1993. P. Ex. 27 at 13, 15.
254. On August 9, 1993, resident 16 was discontinued from the RNA
program. P. Ex. 27 at 17-18.
255. Nurse assistant records in resident 16's chart indicated that
resident 16 was ambulated daily throughout November and December
1993. Tr. 1517-1523, P. Ex. 1 at 14-17.
256. Resident 16 was ambulated routinely following the conclusion
of the RNA program. Id.
257. HCFA did not prove that resident 16's ambulation declined.
258. The testimony of HCFA's witnesses on this issue is
conflicting and unpersuasive.
259. HCFA did not prove that resident 16 was not maintained at her
highest practicable level with respect to her ambulation.
260. Petitioner was not deficient with regard to maintaining the
ambulation of resident 16 at its highest practicable level.
F 320 (Pressure sores) (pp. 164-167)
261. The purpose of using a Tegaderm dressing in treating resident
31 was to act as a barrier to protect her pressure sores from
bacteria, to keep in place the gel that was used to treat the
sores, and to prevent further skin breakdown caused by the open
sores coming into contact with the resident's bed or bedding. Tr.
2620-2621.
262. At the time of the survey, the surveyor observed that the
dressings were not in place. Tr. 241.
263. Resident 31 had more than one Tegaderm dressing missing. Id.
This put her at a greater risk for bacterial infection. Tr. 2621.
264. Resident 31's treatment record indicated that the dressings
were in place and had been checked for proper placement on the
previous shift. Tr. 241.
265. Petitioner failed to follow the physician's order concerning
treatment of resident 31's pressure sores.
266. Petitioner violated 42 C.F.R. 483.25(c)(2) with respect to
the treatment of resident 31.
F 324 (Range of motion) (pp. 167-168)
267. HCFA has conceded that resident 2 is not the correct subject
of this deficiency. HCFA Br. at 72.
268. Examples of residents who were discussed in other
deficiencies would not corroborate the allegations in this
deficiency, because the HCFA 2567 mentioned no cross-references
with regard to this deficiency.
269. HCFA did not prove that Petitioner was in violation of 42
C.F.R. 483.25(e)(2).
F 373 (facility must offer snacks at bedtime daily) (pp.
168-174)
270. Petitioner's monthly flow sheets, particularly those with
dashes, "NA", "N", and "no", support a finding
that a number of
residents were not offered bedtime snacks and were not on special
diets which would have precluded the consumption of such food.
271. Ms. Downing's explanation of the meaning of a dash, and
arguably similar meanings for "N", and "no", is lacking
in
credibility.
272. Bedtime snacks were neither offered nor provided.
273. While Petitioner provided special snacks to residents who
requested something different than the routine snacks (Tr.
2039-2040; Id. at 73-93), this does not demonstrate compliance with
the regulation, which requires Petitioner to offer bedtime snacks
to all residents unless it is medically contraindicated.
274. There is no credible evidence that Petitioner's policy was
revised before the survey was completed.
275. Petitioner implemented the "Procedure for Bed Time (H.S.)
Snack" policy reflected in P. Ex. 30 at 94-95 after the survey was
completed and the plan of correction was submitted.
:\C Petitioner demonstrated a pattern of violating the regulation
requiring residents to be offered bedtime snacks.
277. Petitioner's failure to provide snacks as required by
regulation would likely result in a diminishment of the mental and
psychosocial well-being of its residents.
278. Petitioner failed to provide bedtime snacks daily to all of
its residents, in violation of 42 C.F.R. 483.35(f)(3).
F441 (Infection control program) (pp. 174-181)
279. The nurse's actions at issue were inconsistent with standard
protocol.
280. The gravity of this breach in acceptable protocol was a
substantial action supporting the deficiency.
281. The medication nurse's acts of placing a juice container from
the medication cart onto the over-bed table of a resident on
contact isolation with MRSA [methicillin resistant staphylococcal
aureaus], and then returning the container to the medication cart,
represented a failure by Petitioner to control and prevent
infections as required by 42 C.F.R. 483.65(a)(1).
282. The statement that Petitioner failed to use sterile and/or
aseptic technique in the care of residents with decubitus open
areas, as written in the HCFA 2567, is vague and confusing. The
document did not make clear whether this part of the alleged
deficiency related to the observation of the treatment of one
resident or more than one resident, and whether the deficiency
related to the failure to follow sterile technique, aseptic
technique, or both.
283. Ms. Shekell's testimony as a whole emerged confused and
contradictory.
284. HCFA failed to prove what specific policies and procedures
Petitioner was required to follow, and did or did not follow, with
respect to sterile and/or aseptic treatment of resident wounds.
:\C HCFA did not prove that Petitioner failed to use sterile
and/or aseptic technique when required.
286. HCFA did not prove that sterile and/or aseptic technique was
not followed by Petitioner when required to control and prevent
infection as required by 42 C.F.R. 483.65(a)(1)
F 443 (Infection control program) (p. 181)
287. The HCFA 2567 does not set forth a finding or basis for F
443.
288. Ms. Shekell admitted that F 443 had been inadvertently keyed
into the computer. Tr. 257.
289. There is no deficiency here.
F 462 (Resident rooms) (p. 182)
290. HCFA did not prove this deficiency.
F 527 (Clinical records) (p. 182-183)
291. HCFA did not prove this deficiency.
Findings summarized and concluded (p. 183)
292. Under 42 C.F.R. 489.13, even one deficiency could be the
basis for a delay in the effective date of certification.
293. Deficiencies showing a lack of compliance with 42 C.F.R.
483 et. seq. were present during the survey of Petitioner, were not
corrected at completion of the survey, and were the subject of an
acceptable plan of correction submitted on January 31, 1994.
294. Accordingly, I affirm HCFA's determination that Petitioner's
certification as a Medicare provider was effective on January 31,
1994.
II. Background
Title XVIII of the Social Security Act, 42 U.S.C. 1395 et
seq., commonly known as the Medicare Act, establishes a federally
subsidized health insurance program for the elderly and disabled
which is administered by the Secretary of the Department of Health
and Human Services (the Secretary). The Secretary has delegated to
HCFA the responsibility for carrying out many of the duties under
this program.
Skilled nursing facilities or other entities may participate in the
Medicare program by entering into a "provider agreement" with the
Secretary. 42 U.S.C. 1395x(u) and 1395cc. A skilled nursing
facility is defined under section 1819(a) of the Social Security
Act (Act) as an institution which is primarily engaged in providing
skilled nursing care and related services for residents who require
medical or nursing care, or rehabilitation services for the
rehabilitation of injured, disabled, or sick persons, and is not
primarily for the care and treatment of mental diseases.
Additionally, such an institution must meet also the requirements
of 42 U.S.C. 1395i-3(b), (c) and (d).
DHS-San Diego is authorized to perform surveys of skilled nursing
facilities to make recommendations to HCFA on whether such
facilities meet the Federal requirements for participation in the
Medicare program. 42 U.S.C. 1395aa(a). Onsite inspections
(surveys) of facilities must be conducted without any prior notice
to the facility. See 42 U.S.C. 1395i-3(g)(2)(A). The results
of Medicare related surveys are used by HCFA as the basis for its
decisions regarding a facility's initial or continued participation
in the Medicare program. The findings of state agencies are
recommendations to HCFA, which makes the actual determination as to
whether a facility is eligible to participate or to remain in the
program. 42 C.F.R. 489.10.
Petitioner is a skilled nursing facility, with approximately 300
beds, operating in San Diego, California. Tr. 1644.
On December 14-23, 1993, Petitioner was surveyed on behalf of HCFA
by surveyors from DHS-San Diego. The purpose of the survey was to
determine whether Petitioner was conducting its operations in
compliance with the requirements of the Medicare program.
Following the survey, DHS-San Diego issued to Petitioner a document
captioned "Statement of Deficiencies and Plan of Correction" (HCFA
2567), which sets out the deficiencies identified during the
survey. Although the State surveyors found Petitioner to be in
compliance with all Level A requirements imposed by HCFA for
skilled nursing facilities, there were numerous Level B
deficiencies identified at the time of the survey. HCFA Ex. 2.
Petitioner was found to have failed to comply with various
regulations governing a skilled nursing facility's participation in
Medicare. These were: 42 C.F.R. 483.13(a); 483.15(h)(3);
483.20(b)(1); 483.20(b)(5); 483.20(b)(6); 483.20(c)(1);
483.20(d)(1); 483.20(d)(2)(ii); 483.20(d)(2)(iii); 483.20(d)(3);
483.25; 483.25(c)(2); 483.25(e)(2); 483.35(f)(3); 483.65(a)(1);
483.65(a)(3); 483.70(d)(1); and 483.75(l)(1). Id.
On January 31, 1994, Petitioner submitted its plan of correction to
the DHS. HCFA Ex. 2. 5/ By letter dated February 23, 1994, HCFA
notified Petitioner that it was certifying Petitioner as a provider
in the Medicare program, effective January 31, 1994, the date of
Petitioner's acceptable plan of correction. HCFA Ex. 5. On
February 28, 1994, HCFA sent an amended notification letter
(changing only the designation of fiscal intermediary). HCFA Ex.
6.
HCFA twice reconsidered its determination at Petitioner's request.
By letters dated March 25, 1994 and May 6, 1994, HCFA notified
Petitioner that it found no basis to alter its original
determination. HCFA Exs. 8, 9. Petitioner requested further
review of the HCFA 2567 findings by DHS headquarters in Sacramento.
DHS informed Petitioner that the earliest possible certification
date was January 31, 1994. HCFA Ex. 10.
III. Evaluation of the credibility of Jacqy Downing
At the hearing, I heard testimony regarding the circumstances
surrounding an internal investigation of DHS-San Diego where Ms.
Downing worked and the reasons why Ms. Downing left her position at
DHS-San Diego in January 1994. This testimony is relevant to the
extent that it enables me to assess the credibility of Ms. Downing,
one of Petitioner's primary witnesses in this case.
Ms. Downing denied any knowledge of problems regarding the
falsification of complaint documents in her office. Tr. 2074. She
stated merely that "[t]here were many allegations going on in that
department." Id. The allegations "involved everybody in the
office including myself and the supervisor." Id.
Ms. Downing testified that a complaint is filed by a third party
(private citizen or an employee or anonymously) to DHS-San Diego
regarding a particular facility. Tr. 2087-2088. The surveyors in
the office then investigate the complaints that are filed against
the facilities. Tr. 2089. The surveyors are supposed to
investigate every complaint. Id. One example of a complaint that
might be filed by the public would be that the facility is not
providing a relative or loved one with the appropriate care. Id.
Ms. Downing admitted that an investigation "was going on" in the
office "at the time [she] retired." Tr. 2078. She stated that she
"didn't have any clear understanding of what the investigation
was." Tr. 2084. She denied any knowledge that the focus of the
investigation was that complaint results were being reported which
had not been investigated. Tr. 2096. She claimed that she was
never informed of this by any of the investigators. Id.
Ms. Downing stated that she was not "personally
confronted" with charges concerning the investigation nor were any
allegations concerning any impropriety brought to her attention
during her interview with the investigators. Tr. 2084, 2086-2087.
She stated further that no one told her that the complaints at
issue originated out of her survey team. Tr. 2084. She also
denied that the investigation specifically concerned herself and
Judith Chute. Tr. 2075-2076.
To counter the testimony of Ms. Downing, HCFA presented the
testimony of Joan Allison, who works for DHS in the licensing and
certification program as the chief of field operations for the
southern region. Tr. 2735-2736.
After reviewing the testimony of Ms. Downing and that of Ms.
Allison, as well as the other evidence, I conclude that Ms.
Downing's testimony regarding the circumstances surrounding the
DHS-San Diego investigation and the reasons why she left DHS-San
Diego was less than forthright and, at times, not consistent with
the actual events surrounding her departure from DHS. I find Ms.
Allison's testimony, which I discuss below, to be credible and
accept it as being a truthful and accurate account of the events in
question. Ms. Downing's attempt to hide the true nature of the
DHS-San Diego investigation that began in October 1993 greatly
undermines my confidence in her credibility.
Ms. Allison testified that she participated in an internal
investigation in October and November 1993 involving DHS-San Diego.
Tr. 2738-2739, 2781. She stated that
the focus of the investigation was to determine whether or not
complaint documents had been altered in the San Diego district
office.
Tr. 2738.
Ms. Allison explained why the investigation was initiated:
A surveyor in the San Diego district office pulled a facility
file and discovered a 2567 that she had completed and found that
the date had been whited out, the signatures for the evaluator and
the supervisor had been whited out, the complaint numbers had been
whited out. She was disturbed at that and looked further in the
folders and found that her 2567 has been duplicated and then other
information had been written in to represent a 2567 on another
complaint investigation.
Tr. 2738; see also Tr. 2743.
Ms. Allison indicated that she and Paul Keller, who was then chief
of field operations for the southern region, went to DHS-San Diego
and interviewed the district manager, the district administrator,
all of the supervisors, including Ms. Downing, and one of her
surveyors who allegedly falsified the documents. Tr. 2740; Tr.
2755-2756.
Ms. Allison testified that approximately 80 survey documents had
been altered. Tr. 2743. She stated that the falsified documents
had Ms. Downing's name "signed as the supervisor." Id. Ms.
Downing's name was the only name signed as supervisor on all of the
falsified documents. Id.
Ms. Allison stated:
The investigation determined that Ms. Downing had given
specific directions to the surveyor in terms of how to prepare
these complaint documents including whiting out the information and
preparing the complaint documents in that way. And then,
subsequently, in approving and sending forward all of these
complaints as if they had, in fact, been legitimately investigated.
Tr. 2745.
It was determined that Ms. Downing had given her approval and sent
forward all of these complaints as falsified. Tr. 2745. Ms.
Allison stated that no other supervisors were the focus of the
investigation. Tr. 2743.
Ms. Allison testified also that the department's audits and
investigations division conducted a second investigation. Tr.
2778, see Tr. 1758. The results of this investigation confirmed
the findings of her and Mr. Keller's investigation. Tr. 2778-2779.
Thus, contrary to Ms. Downing's claims of lack of knowledge
regarding the details of the internal investigation, there can be
little doubt that Ms. Downing was being investigated regarding the
allegations and was aware of it. Although Ms. Downing had claimed
in her testimony that she was never confronted with charges
involving herself, Ms. Allison testified that
Ms. Downing was notified that both -- that both she and the --
a particular evaluator were specifically being investigated
relative to the charges. Tr. 2782.
Ms. Allison testified that when Ms. Downing was asked if she
participated in the falsification of the documents, Ms. Downing did
"[n]ot categorically" deny it. Tr. 2755. Ms. Allison stated that,
by way of explanation, Ms. Downing had said that her surveyor may
have misunderstood her directions, and also that she (Ms. Downing)
may not have paid close attention to work since her parents were
not well. Tr. 2755. Ms. Allison went on to say that Ms. Downing
had said "that when she advised her evaluator to do some cut and
paste, it had not been her intention that they would reflect
investigations that had not been completed." Id.
Based on Ms. Allison's testimony, I find Ms. Downing's earlier
testimony that she "didn't have any clear understanding of what the
investigation was" (Tr. 2084) is simply not factual and
demonstrates her attempt to recast the events as favorably as
possible with respect to her involvement in the investigation.
At the hearing, when asked by HCFA's counsel why she left DHS, Ms.
Downing responded that she "chose to retire." Tr. 2074. She
denied that she was asked to leave DHS. Tr. 2075. Ms. Downing
stated that she had made the decision to retire on her birthday the
year before. Tr. 2077. She testified that she was eligible for
retirement in the state system and claimed to have filed for
retirement in mid-December 1993. Tr. 2079-2081. In the
retirement papers, Ms. Downing stated that she had given her
intention to retire in January 1994. Tr. 2081.
Ms. Allison's testimony also called into question the veracity of
Ms. Downing's testimony regarding her retirement from DHS. Ms.
Downing testified that she was not asked to leave DHS (Tr. 2075).
However, according to Ms. Allison, as a result of the
investigation, in December 1993, DHS served both Ms. Downing and
the evaluator with an action to dismiss from State service. Tr.
2746, 2756, 2759-2760. 6/
Prior to a State hearing, DHS and Ms. Downing reached a stipulated
agreement, which required Ms. Downing to resign effective January
14, 1994. Tr. 2746, 2758, 2779. A hearing did not take place.
Tr. 2758. Ms. Downing resigned in accordance with the stipulated
agreement. Tr. 2779.
When asked by Petitioner's counsel whether Ms. Downing had applied
to retire before any adverse action was taken against her by DHS,
i.e., before December 30, 1993, Ms. Allison responded that she was
unaware that Ms. Downing had submitted anything prior to being
served with the adverse action. Tr. 2757, 2766-2767. She stated
that she also had no knowledge as to whether Ms. Downing expressed
a desire to resign earlier than January 14, 1994. Tr. 2780. Ms.
Allison expressed her belief that DHS would not have issued the
dismissal notice to Ms. Downing if it had known that Ms. Downing
was planning to retire. Tr. 2780.
The record before me contains the stipulation and settlement
entered into between Ms. Downing and DHS in February 1994. HCFA
Ex. 14. Among its provisions, this document states that DHS
"agrees to withdraw its Notice of Adverse Action against Appellant
[Ms. Downing] dated December 30, 1993." Another provision states
that the "Appellant agrees to resign from state service effective
January 14, 1994." HCFA Ex. 14. Based on Ms. Allison's testimony
and the contents of this document, Ms. Downing's assertions that
she had already planned to retire and that she had filed for
retirement in mid-December 1993, seem suspect. Although she
claimed to have filed retirement papers, which state January 1994
as her intended retirement date, no such documents were ever
produced. While it may have been Ms. Downing's choice to retire,
the evidence strongly indicates that, had she not resigned, DHS
would have proceeded with its adverse action against her. I need
not determine whether Ms. Downing had intended to retire. Whether
she had that intention or not, the circumstances of the
investigation and proposed adverse action overtook any such plans
and were the actual reasons for her departure from DHS in January
1994.
Ms. Downing's testimony regarding the internal investigation and
the circumstances of her resignation was less than truthful. Her
questionable credibility requires me to take a cautious approach in
ascribing weight to her other testimony on the substantive matters
of this case. She clearly was an advocate for the positions put
forth by Petitioner, her employer. She has credible credentials in
the field of nursing and knowledge of the survey methodology
followed by the DHS while she was employed there. However, I found
that testimony, which, at times, supported positions taken by HCFA
in this proceeding, was given by Ms. Downing with reluctance and
hesitation. Moreover, at times, her testimony supporting
Petitioner's positions did not comport with other, credible,
evidence. Ms. Downing's testimony will be discussed with greater
particularity in relation to the specific deficiencies to which her
testimony applies.
Petitioner has raised a number of legal issues regarding the
applicability and effect of the regulations pertaining to the DHS
survey in December 1993 and HCFA's selection of January 31, 1994 as
the effective date of Petitioner's Medicare participation. I will
address each of these issues seriatim.
IV. Issue:
Whether 42 C.F.R. Part 488, Subpart C -- Survey Forms and
Procedures, was controlling on thesurvey conducted in this case.
HCFA argues that the guidelines applicable to the survey in this
case are contained in State Operations Manual 250 (SOM 250) and
that the survey materials set forth at 42 C.F.R. Part 488, Subpart
C, "became obsolete and devoid of legal force or effect when the
OBRA '87 [Omnibus Budget Reconciliation Act of 1987] provisions
went into effect on October 1, 1990." HCFA Resp. Br. at 58. HCFA
contends that the "survey forms, procedures and guidelines
contained in Subpart C not only are inconsistent with and do not
implement these new health care requirements, they conflict" with
the OBRA '87 requirements. Id. HCFA alleges that the Subpart C
survey materials have been replaced by those contained in SOM 250.
HCFA claims that "Petitioner has never maintained that it was
unable to respond to the survey findings due to the use of the SOM
250 protocols." HCFA Resp. Br. at 68. Finally, HCFA asserts that
a federal district court order suspended Subpart C and gave HCFA
the authority to use SOM 250 "on indefinite interim basis." HCFA
Resp. Br. at 56 9.
In response, Petitioner disputes that OBRA '87 impliedly repealed
42 C.F.R. Part 488 Subpart C. (P. Br. at 8) and argues that HCFA's
position "has no legal basis." P. Br. at 13. Petitioner contends
that "42 C.F.R. 488.110 [is] still valid and binding on HCFA."
P. Br. at 20. Petitioner argues that the SOM 250 survey procedures
"effectively change those set forth in 42 C.F.R. 488.110." Id.
Petitioner claims that the SOM 250 procedures should have been
promulgated in accordance with the rulemaking requirements of the
Administrative Procedure Act because they are "substantive" in
nature, and the failure to have done so renders them invalid. P.
Br. at 17-20.
In discussing this issue, it is necessary to review the historical
background of OBRA '87 and the efforts undertaken by HCFA to
implement it.
A. OBRA '87
The nursing home reform provisions of OBRA '87 set minimum
statutory standards that skilled nursing facilities (SNFs) must
meet to participate in Medicare and nursing facilities must meet to
participate in Medicaid, provided nursing home residents with
certain rights, and established a structure for state and federal
surveys and certifications of nursing homes. 42 U.S.C.
1395i-3 and 1396r. These requirements were in effect as of October
1, 1990. Sections 4202(a) and 4214(a) of OBRA '87.
OBRA '87 fundamentally changed the survey and certification process
by establishing a patient-oriented system to assess the quality of
care actually furnished. See 42 U.S.C. 1395i-3(f) and (g); 42
U.S.C. 1396r(f) and (g). These revisions established new
standards governing the provision of care in nursing facilities,
including requirements relating to the quality of patient life,
licensed nursing services, nurse aide training, residents' rights,
and many other aspects of nursing home operation and
administration. 42 U.S.C. 1395i-3(b), (c) and (d); 42 U.S.C.
1396r(b), (c) and (d). The statute specifies the content,
procedures and frequency of surveys, as well as survey team
composition. 42 U.S.C. 1395i-3(g)(2) and 42 U.S.C.
1396r(g)(2).
Under OBRA '87, each state is responsible for certifying that SNFs
are in compliance with the requirements of the Act through the use
of surveys conducted pursuant to certain specified protocols.
Congress specified in OBRA '87 that the Secretary develop, test and
validate by no later than January 1, 1990 survey protocols for the
standard and extended surveys required by law. Also, by such date,
the Secretary was to develop minimum qualifications for members of
the team who are to conduct such surveys. Congress further stated
that the failure of the Secretary to carry out these mandates by
January 1, 1990 shall not relieve any state or the Secretary of the
responsibility to conduct surveys required by OBRA '87. 42 U.S.C.
1395i-3 and 1396r.
In the legislative history of OBRA '87 7/, the House committee
explained that the bill would repeal the current Medicare
participation requirements for SNFs, as well as the current survey
and certification requirements, and replace them with new
requirements. H.R. Rep. No. 391, 100th Cong., 1st Sess., part 2,
at 926, 938 (1987).
The report states that "[a] skilled nursing facility must care for
its residents in such a manner and in such an environment as would
promote maintenance or enhancement of the quality of life of each
resident." Id. at 927. Further, the report indicates that, for
this goal to be attained, certain shortcomings in the current law
must be addressed. For example, the report notes, among other
things, that the current law does not require the use of resident
assessments nor does it require that a resident assessment be
linked or coordinated with a resident's care plan. Id. at 926. To
remedy the aforementioned shortcomings, the committee set forth
requirements in the bill concerning written care plans and resident
assessments. 8/ The report states:
The Committee intends that the resident assessment instrument
or instruments developed by the Secretary have the following
characteristics. First, when used by a trained observer, the
instrument should describe the capacity of the resident, at the
time of observation, to function independently. Second, when used
by another trained observer on the same resident at the same time,
the result should be the same as that obtained by the first
observer. Finally, the descriptive portions of the resident
assessment instrument should be helpful to nursing facility staff
in planning care, but the assessment of the resident's functional
capacity should not be either prognostic or prescriptive. . . .
Because the resident assessment is one of the critical
underpinning at high quality care, accuracy in describing the
functional capacity and health status of each resident is
essential. To clarify accountability, section 4111 of the
Committee amendment would require that a registered professional
nurse sign and certify the accuracy of each assessment. . . .
H.R. Rep. No. 391, 100th Cong., 1st Sess., part 1, at 465 (1987).
9/
The report states, among other things, the committee's view on
physical restraints:
The committee is very concerned about reports of deaths due to
physical restraints, and so to better protect residents, restraints
may only be imposed to ensure the physical safety of the resident
or other residents and only upon the written order of a physician
that clearly specifies the duration and circumstances under which
the restraints may be used. However, in emergency situations, as
specified by the Secretary, to protect the safety of the resident
or other residents in the facility, the resident could be
restrained for a short period of time until a physician order could
reasonably be obtained. The committee intends that restraints used
in emergency conditions would be used only in unanticipated
situations and that every effort would be made to obtain a
physician's written order as quickly as possible.
Id. at 932.
With respect to the survey and certification process, the report
states:
The current survey and certification system has been in effect
since 1974. It focuses on structural requirements (e.g., written
policies and procedures, staff qualifications and functions, and
physical plant characteristics), not on resident outcomes (e.g.,
presence or absence of bedsores or infections, extent of cognitive
impairment). The IOM Committee identified a number of major
problems with the current survey process, including predictability,
inefficiency, an emphasis of paper compliance, insensitivity to
resident needs, inconsistency, and lack of coordination with
ombudsman programs and other monitoring processes. The IOM
Committee urged the adoption of a resident-centered,
outcome-oriented survey process . . .
Id. at 466. 10/
The conference report states:
The conferees also suggest that the Secretary consider, in
establishing criteria by which the standard survey will measure
quality of care furnished by a facility, such factors as vision and
hearing; activities of daily living; use of physical restraints;
accidents; nutrition and fluid intake; cognitive, behavioral, and
social functioning; use of urinary catheters; prevention and care
of pressure ulcers; and use of drugs.
H.R. Conf. Rep. No. 495, 100th Cong., 1st Sess., 715 (1987).
This legislative history demonstrates congressional intent to
implement major reforms in nursing home care and to create a
resident-centered, outcome-oriented survey process. Congress,
moreover, intended to significantly alter the conditions of
participation for SNFs and to direct the focus and format of
surveys conducted by states to those new conditions of
participation. In fact, the Secretary was directed to develop new
survey protocols which were consistent with the mandates of OBRA
'87.
B. HCFA's rule-making activities from July 1987-November 1994
In July, October, and November 1987, HCFA published proposed rules
which dealt with the survey and certification process, conditions
of participation, and enforcement regulations. 52 Fed. Reg.
24,752, 38,582, and 44,300. 11/ While HCFA was considering public
comments on the latter two proposed sets of regulations, Congress
enacted OBRA '87 in December 1987.
In the preamble to the July 1, 1987 proposed regulations, HCFA
stated that it was proposing these regulations in response to the
U.S. District Court decision in Estate of Smith v. Bowen, 656 F.
Supp. 1093 (D. Colo. 1987), in which the court found that an
earlier rule published on June 13, 1986, titled "Medicare and
Medicaid Programs -- Long-Term Care Survey" was procedurally
invalid. The court had ordered HCFA to publish a new proposed rule
by July 1, 1987 addressing the problems which had been identified.
52 Fed. Reg. 24,752-24,753.
On June 17, 1988, HCFA, acting in accordance with a February 18,
1988 court order in Smith v. Bowen, promulgated final regulations
amending the Medicare and Medicaid survey regulations then in
effect. These final regulations were based on the proposed
regulations published in July 1987. 53 Fed. Reg. 22,850 (1988).
Among the new regulations promulgated were 42 C.F.R. Part
488 Subpart C. The preamble acknowledges Congress' enactment of
OBRA '87:
[a] new survey process is required by OBRA '87, effective in
1990. In addition, due to the new statutory provisions, we are
withdrawing our proposed rule on Survey and Certification of Health
Care Facilities (52 FR 44300), and will publish a new proposed rule
incorporating the OBRA '87 provisions.
*****
We are developing final rules on conditions of participation
for long term care facilities
. . . In the meantime, we are complying with the court order
by publishing these regulations, and we are planning additional
revisions to the survey process rules at a later date after we
issue a final rule that revises the conditions of participation.
Id. at 22,850, 22,851.
With regard to survey forms and guidelines, the preamble emphasizes
that
[w]e are deferring major forms design and content changes to
coincide with the planned refinements in the overall survey process
that will be necessitated in conjunction with the revised long
term care conditions of participation and the new OBRA '87
requirements. [Id. at 22,856.]
When the new conditions of participation are published as
final regulations, we will make necessary refinements to the survey
process, forms and guidelines. [Id. at 22,853.]
The preamble notes the breadth of the changes under consideration:
Although we are publishing this final rule now, in compliance
with the court's order, we are also in the process of instituting
more far-reaching changes in the nursing home conditions of
participation and enforcement regulations that underlie the long
term care survey process. [Id. at 22,850.]
. . . OBRA '87 and the revised conditions of participation for
long term care facilities will implement substantive changes to the
nursing home requirements and corresponding changes to the long
term care survey process. [Id. at 22,851.]
Also, the preamble states unequivocally that the survey procedures
and guidelines being published at that time were "rooted in the
current nursing home requirements which are the conditions of
participation for SNFs. . ." Id. at 22,853.
HCFA's rule-making activities continued in February 1989, when it
published as final regulations (with a comment period) a revised
version of its October 1987 proposed rule. 54 Fed. Reg. 5316
(1989). These regulations, effective August 1, 1989 (except when
specified otherwise in the Federal Register), concerned
requirements that long-term care facilities were required to meet
to participate in the Medicare and Medicaid programs. 12/ In the
preamble, HCFA stated that, "[i]n addition to numerous technical
revisions made by OBRA '87, in this final rule, we are
incorporating the following major OBRA '87 requirements . . ." 54
Fed. Reg. 5317. HCFA stated also that it "plan[ned] to publish
other, related regulations in addition to this final rule" to
implement OBRA '87. Id. HCFA stated further that "[t]his
legislation [i.e., OBRA '87] covered many of the provisions that
appeared in the proposed rule. Therefore, many of the provisions
that we are adopting in this final rule are now legislative
provisions." 54 Fed. Reg. 5355. Due to the extensive revisions to
the regulations mandated by numerous OBRA '87 provisions, HCFA
published a derivation table setting forth the source of each of
the newly promulgated conditions of participation contained in the
final regulations. 54 Fed. Reg. 5354-5355.
In September 1991, HCFA published final regulations which revised
the February 2, 1989 final regulations. 56 Fed. Reg. 48,826
(1991). These 1991 regulations reflected
HCFA's response to public comments and included some changes
required by OBRA '90. In the preamble, HCFA explained:
The February 2, 1989 revision of the nursing home regulations
was the most extensive set of Federal regulatory changes in this
area of the health care industry in 15 years. We revised the
requirements that long term care facilities must meet in order to
receive Federal funds for the care of residents who are Medicare
beneficiaries or Medicaid recipients. We issued the regulations .
. . to refocus the requirements for participation in both programs
to actual facility performance in meeting residents' needs in a
safe and healthful environment. The previous set of requirements
had focused on the capacity of the facility to provide appropriate
care. In addition, we needed to simplify Federal enforcement
procedures by using a single set of requirements that apply to all
activities common to [skilled nursing facilities], [intermediate
care facilities], and [nursing facilities]. . . .
OBRA '87 departs from previous Congressional practice by
specifying many details which prior law leaves to the authority of
the Secretary. It also contains entirely new requirements which
are also specified in detail.
56 Fed. Reg. 48,826.
Based on this preamble language, there can be little doubt that
HCFA was continuing to respond to the enactment of OBRA '87 by
making numerous changes in the regulatory requirements concerning
conditions of participation and the survey process for long-term
care facilities.
In August 1992, HCFA published proposed regulations which would
further implement provisions of OBRA '87, as further amended by
1988, 1989, and 1990 legislation. 57 Fed. Reg. 39,278 (1992).
With regard to survey procedures and guidelines, HCFA provided in
the preamble the following background information to the survey
process that existed as of August 1992:
Sections 1819(g)(2) and (3) and 1919(g)(2) and (3) of the Act,
as added by sections 4202 and 4212 of OBRA '87 specify the
requirements for types and periodicity of surveys that are to be
conducted for each facility; including standard, special, partial
extended, extended, and validation surveys. These provisions
include specific contents and procedures, frequency, consistency,
and team composition. These regulatory provisions are an integral
part of the long term care survey and enforcement system and along
with the requirements for long term care facilities published in a
final rule on September 26, 1991 (56 FR 48826), and the
interpretive guidelines and survey procedures issued in September
1989, and revised in April 1992 [emphasis added 13/], complete the
execution of the long term care survey and certification process
mandated under OBRA '87. This fully integrated system provides the
comprehensive framework to ensure uniform surveyor interpretation
of substandard care, and to guide recommendations with respect to
the determination of appropriate remedies.
57 Fed. Reg. 39,283 (1992).
HCFA further described in the preamble the purpose and framework
for the recently published interpretive guidelines and survey
procedures as follows:
The interpretive guidelines and survey procedures direct the
State agency surveyors to gather information on facility
performance relating to the delivery of care and services to the
residents in the facility. These surveyor instructions structure
the information gathering process and assist the surveyors in
identifying situations that are indicative of a facility's
compliance with the regulations. Moreover, the surveyor guidelines
provide the surveyors with a consistent structure to evaluate the
situation and the framework to analyze the information prior to
making a compliance decision.
. . . The survey guidelines provide the surveyors with
structured information gathering procedures and interpretations
related to the requirements that permit the surveyors to make
consistent deficiency determinations. However, we do recognize
that in many instances the decision with respect to whether a
deficiency exists is ultimately a decision of professional judgment
related to the particular situation observed and the context of the
regulations. Therefore, to assure consistency, we promote team
decision making and provide comprehensive training on the
regulations and documentation techniques.
Id.
The language cited above spells out the evolving process undertaken
by HCFA in carrying out the OBRA '87 mandates. The survey
procedures and guidelines in 42 C.F.R. Part 488, Subpart C, were
revised by HCFA to comply with congressional directives in OBRA
'87 to develop new protocols. These protocols were published in
April 1992 as SOM 250. While HCFA made no specific reference to
SOM 250 in the preamble to the August 1992 proposed regulations,
the scope and purpose of this publication is also evident. When
the proposed regulations were published in final form in November
1994, with an effective date of July 1, 1995, HCFA, in response to
comments concerning the variation in surveys conducted by state and
federal surveyors, stated:
[T]he long term care survey protocol has only been in effect
since October 1990, with appropriate instruction enhancements for
the final long term care regulations which were effective April 1,
1992. It is not unusual that some variation in emphasis will occur
in a new survey process [emphasis added].
59 Fed. Reg. 56,116, 56,145 (1994).
Of particular interest to this proceeding is HCFA's response to a
comment that a facility would not know what was required of it
prior to being cited for a deficiency:
There is no reason why any Medicare or Medicaid provider
should be unaware of program participation requirements. The
requirements are public knowledge, and it is incumbent upon
facilities that enter into Medicare and Medicaid agreements to
familiarize themselves with the requirements with which they have
voluntarily agreed to comply. Moreover, copies of the State
Operations Manual Transmittal No. 250, which contains the
interpretive guidelines, procedures and forms used by surveyors to
assess facility compliance are available to the public . . .
[emphasis added].
Id. at 56,227-56,228.
Even though this quoted language from the Federal Register
post-dates the survey of Petitioner in December 1993, HCFA
correctly stated that any facility, such as Petitioner, is expected
to know of the regulations governing its facility and of the
interpretive guidelines governing the conduct of surveyors who
measure the facility's compliance with such regulations. As of
December 1993, Petitioner had been the subject of prior state
surveys and was or should have been on notice as to the
requirements imposed by OBRA '87 on SNFs.
HCFA referred to SOM 250 in several instances when responding to
public comments. For example, on the topic of a facility's attempt
to accommodate a resident in terms of care alternatives, HCFA
responded, in part, "[w]e believe such specific instructions are
more appropriately located in the State Operations Manual than in
the regulation itself, so we are not incorporating them into the
regulation." 59 Fed. Reg. 56,134. In responding to another
comment on the topic of nursing services staff, HCFA said: "[w]e do
specifically address a review of staffing in Appendix P of the
State Operations Manual Transmittal No. 250." Id. HCFA again
directs attention to Appendix P of the SOM 250 when it discusses
audits, reiterating its belief that "such detailed instruction is
more appropriate in the manual than in the regulation itself, and
so we are not including it in the regulation." 59 Fed. Reg.
56,135.
The preamble addresses also survey protocol and instances where
there may have been a failure to completely comply with such
protocol. HCFA stated:
Sections 1819(g)(2)(C) and 1919(g)(2)(C) of the Act reveal the
intent of the Act very clearly. These sections state that standard
surveys must be conducted based upon a protocol, but add that the
failure of the Secretary to develop, test or validate such a
protocol will not relieve any State or the Secretary of the
responsibility to conduct surveys. Because the Congress intended
for survey results to be binding even when surveys were conducted
in the absence of a formal protocol, it is clear that the Congress
views the substance of survey findings to be of greater importance
than the process used to identify them.
59 Fed. Reg. 56,133-56,134 (emphasis added).
HCFA further stated:
Moreover, since the source of binding requirements on
facilities is not in the survey protocol, but in the Act and
regulations, the ultimate, and proper, test of facility
noncompliance will not rest on whether the survey protocol was
rigorously followed, but on whether a requirement of the Act or the
regulations has been violated.
Id. at 56,134.
While these explanations of HCFA's intentions regarding the
interplay between 42 C.F.R. Part 488, Subpart C, and SOM 250
post-date the survey in issue in this case, they are instructive in
understanding HCFA's position and providing guidance in construing
the application of Subpart C and the survey protocols in SOM 250.
As illustrated by the foregoing section, HCFA's efforts to carry
out the statutory mandates of OBRA '87 thus spanned several years
following its enactment. It is evident that to successfully
implement the provisions of OBRA '87, HCFA was required to revise,
rewrite, and add numerous regulations. It is also apparent that
the June 1988 final regulations, which included 42 C.F.R. Part 488,
Subpart C, were promulgated by HCFA with great reluctance and only
after being mandated by the court. An obvious concern of HCFA was
the evolving process by which it was implementing the provisions of
OBRA '87 and the need to develop a mechanism which provided
flexibility and allowed for revisions in instructions to state
agencies without the need to institute formal rulemaking every time
changes were necessary.
C. Analysis
In determining the present force and effect of the survey
procedures in 42 C.F.R. Part 488, Subpart C, I am guided by the
fact that those survey procedures and guidelines were the subject
of lengthy deliberations by HCFA, involving several separate
Federal Register pronouncements, with all of these activities
predating the effective date of OBRA '87. Equally persuasive is
the fact that the Federal Register statement accompanying the final
publication of Subpart C leaves no doubt that 1) this Subpart
pertained to conditions of participation for long-term care
facilities that were in effect at the time of publication and 2)
HCFA was, at the time of publication, in the process of making
significant and wide-ranging changes to the existing conditions of
participation based on various amendments to the law, principally
OBRA '87.
A review of Subpart C survey procedures demonstrates that they do
not reflect the new and expanded requirements created by OBRA '87,
including those in the areas of residents' rights, quality of
patient life, quality of care, and dietary, dental, pharmacy,
nursing and physician services. See 42 U.S.C. 1395i-3(b)-(d),
1396r-3(b)-(d); 42 C.F.R. 483.10 - 483.75; 54 Fed. Reg.
5354-5355 (1989). Moreover, the above cited references to the
Federal Register demonstrate that HCFA put SNFs on notice as early
as August 1992 that the interpretive guidelines and survey
procedures used in federal and state surveys were revised in April
1992. At the time of the December 1993 survey, Petitioner was
bound by these survey protocols and by the applicable regulations
pertaining to the conditions of participation set out in 42 C.F.R.
Part 483, Subpart B.
I concur with HCFA's position that Subpart C is inconsistent with
and does not implement the OBRA '87 revisions to the health and
safety requirements that a long-term care facility must meet to
participate in the Medicare and Medicaid programs. HCFA Resp. Br.
at 56-58. Subpart C, while technically still in effect, does not
have any current operational significance since it pertains to
survey methodology and conditions of participation which became
obsolete with the implementation of the new conditions of
participation and survey processes mandated by OBRA '87, which did
not go into effect until October 1990. 14/
The legal underpinning for Subpart C no longer exists. Congress
directed the Secretary to develop new survey protocols to implement
OBRA '87. Subpart C has been replaced by these protocols. HCFA's
failure to withdraw Subpart C and to formally publish the revised
protocols in regulations does not elevate outdated, obviously
obsolete survey procedures and guidelines (Subpart C) to a legal
status which is inconsistent with congressional intent. 15/
Moreover, Congress was cognizant of the possibility that the
Secretary would not develop the survey protocols by January 1, 1990
and directed the states and Secretary to carry out the mandates of
OBRA in the absence of such protocols. See section IV.A. of this
decision, supra.
Apparently ignoring the cited statutory language, legislative
history, and statements by HCFA in publications of the Federal
Register post-OBRA '87, Petitioner argues that the "[e]nactment of
OBRA 1987 has not changed a single regulatory requirement for the
conduct of surveys." P. Resp. Br. at 3. This position is so
totally inconsistent with the record in this case that I do not
give it any serious consideration. One argument Petitioner appears
to make is that the OBRA '87 requirement that each survey include
a "case-mix stratified sample of residents" does not change any
requirement of Subpart C. Id. 16/ This is incorrect. 42 C.F.R.
488.110(d) (which is found in Subpart C) refers to a random sample
and not the case-mix stratified sample which is required by OBRA
'87. 17/ Thus, Petitioner's own reference demonstrates that
Subpart C, as I have found, does not track or adhere to the
requirements of OBRA '87. HCFA's counsel gives other examples of
the inconsistency between OBRA '87 requirements and 42 C.F.R.
488.110 in her reply brief at pages 34-35.
As previously stated in this decision, there is ample support for
the conclusion that OBRA '87 made substantial changes in the
conditions of participation and survey process for long term care
facilities. The statute itself reflects this and HCFA's extensive
analyses of OBRA '87 in the Federal Register leave no doubt as to
its interpretation of the impact of OBRA '87 on then-existing
statutory and regulatory requirements.
Petitioner further argues that 42 C.F.R. 488.110 is binding on
HCFA and the survey protocols and definitions contained therein
were operative at the time Petitioner was surveyed in December
1993. In support of this position, Petitioner points out that 1)
HCFA never formally withdrew 42 C.F.R. 488.110 after OBRA '87
was enacted, and 2) all volumes of the Code of Federal Regulations
(C.F.R.) for the years 1992 to the present continue to contain this
Subpart without revision. Petitioner concludes that, since Subpart
C is the operative standard for the conduct of surveys under OBRA
'87 and HCFA did not follow this standard in conducting the survey
of Petitioner in December 1993, the survey results are a nullity
and cannot be used to delay its certification for Medicare. P.
Resp. Br. at 4-6.
There is no dispute of the obvious fact that, despite OBRA '87,
HCFA has never formally withdrawn 42 C.F.R. Part 488, Subpart C and
has continued to publish it in the C.F.R. This circumstance
presents several legal issues which I will now address.
V. Issue:
Whether HCFA was legally required to formallywithdraw or
repeal 42 C.F.R. Part 488, SubpartC.
Petitioner contends that HCFA never formally repealed 42 C.F.R.
488.110 (which is included in Subpart C) in accordance with the
requirements of the Administrative Procedure Act (APA), and that
its failure to do so makes the agency bound by the contents
therein. P. Br. at 15. Petitioner argues also that the fact that
Subpart C was recently re-published, without any changes, in the
C.F.R. is indicative of its present-day validity. P. Resp. Br. at
5.
HCFA claims that Subpart C was inconsistent with and did not carry
out the directives of OBRA '87 and, thus, lost operational
significance "as a matter of law." HCFA Resp. Br. at 58. HCFA
contends that, with the enactment of OBRA '87, "the survey forms,
procedures, and guidelines of Subpart C were nullified:
administrative repeal was not required." Id. at 60.
I find that HCFA was not legally required to formally withdraw or
repeal Subpart C in order for this subsection to be rendered
inoperative by the passage of OBRA '87, the provisions of which
became effective on October 1, 1990.
In examining the interrelationship between administrative
regulations, statutory language, and congressional intent, the
Supreme Court has expressed the well-settled principle that
congressional desire discerned from a statute is to be effectuated
through promulgated regulations:
[t]he power of an administrative officer or board to
administer a federal statute and to prescribe rules and regulations
to that end is not the power to make law . . . but the power to
adopt regulations to carry into effect the will of Congress as
expressed by the statute. A regulation which does not do this, but
operates to create a rule out of harmony with the statute, is a
mere nullity.
Manhattan General Equipment Co. v. Commissioner of Internal
Revenue, 297 U.S. 129, 134 (1935). In a later case, the Court
again recognized that "regulations, in order to be valid, must be
consistent with the statute under which they are promulgated."
U.S. v. Larionoff, 431 U.S. 864, 873 (1977). Also, a regulation is
invalid if it is "fundamentally at odds with the manifest
congressional design," even if it is not "technically inconsistent"
with the statutory text. U.S. v. Vogel Fertilizer Co., 455 U.S.
16, 26 (1982).
There is no dispute that the contents of Subpart C were never
modified and that HCFA never formally repealed or withdrew Subpart
C. It follows logically that, because Subpart C was never formally
repealed, HCFA was required to re-publish this section in the
C.F.R. However, the mere fact of publication has little bearing on
the issue of whether this subpart has any operational significance
today. In light of the principles enunciated above by the Supreme
Court, the appropriate analysis begins by focusing on the
congressional purpose in enacting OBRA '87.
As discussed previously, the legislative history of OBRA '87
demonstrates that Congress intended to make far-reaching changes in
the survey and certification process to remedy shortcomings in the
law as it then existed. Moreover, the legislative history
underscores congressional intent to create a patient-centered,
outcome-oriented survey process. It is fair to conclude that the
intent of Congress, as expressed in the legislative history of OBRA
'87, is unambiguous.
As discussed earlier in section IV. of this decision , I find that
OBRA '87 imposes many new requirements on long-term care
facilities. These provisions explicitly carry out the
congressional objective of comprehensive nursing home reform. I
conclude that the contents of Subpart C became obsolete with the
implementation of the OBRA '87 provisions (section IV., supra).
Subpart C did not address the new conditions of participation and
survey processes statutorily mandated by OBRA '87. Based on this,
it cannot be disputed that Subpart C is "out of harmony" with OBRA
'87 and, thus, at odds with the will of Congress. To give any
effect to Subpart C would clearly frustrate the congressional
purpose in passing OBRA '87. Moreover, "[w]here an administrative
regulation conflicts with a statute, the statute controls." U.S.
v. Doe, 701 F.2d 819, 823 (9th Cir. 1983). Subpart C must thus be
considered to have lost any operational significance by virtue of
the fact that it conflicts with, and does not carry out, the
directives of OBRA '87.
I agree with HCFA that formal repeal of Subpart C was not required.
Petitioner cites to the case of Am. Fed'n. of Gov't. Employees v.
Fed. Lab. Rel. Auth., 777 F.2d 751, (D.C. Cir. 1985), among others,
in support of its argument that Subpart C should have been repealed
in accordance with the APA rule-making process:
"[A]n agency seeking to repeal or modify a legislative rule
promulgated by means of notice and comment rulemaking is obligated
to undertake similar procedures to accomplish such modification or
repeal . . . .
Id. at 759.
However, the Supreme Court decisions cited above make no mention of
formal repeals in the instances where a regulation does not
effectuate the congressional design. For example, the Court has
held that certain Defense Department regulations conflicted "with
the congressional intention in enacting the VRB program, and hence
[are] invalid." U.S. v. Larionoff, 431 U.S. at 877. The absence
of any explicit reference by the Court regarding repeal gives rise
to the inference that such regulations are to be found null, and
thus, invalid. Furthermore, because the Court in Larionoff did not
refer at all to APA requirements in declaring the regulations to be
invalid, I infer that such requirements do not have to be met.
Even without this interpretation, it can be argued that the import
of repealing the regulation is to provide notice to the public that
the agency is no longer relying on such regulation in carrying out
the congressional mandate upon which the regulation is based.
Here, the Federal Register references previously cited in section
IV., reflect the fact that HCFA specifically and clearly notified
the public that the survey protocols and procedures in Subpart C
were replaced by SOM 250.
In any event, in the matter before me, it appears that HCFA was
prohibited from repealing Subpart C based on the interim order
issued by the federal court in Colorado in the case of Estate of
Smith v. Sullivan, on September 27, 1990. The order stated, in
part: "Effective October 1, 1990, the Secretary shall be permitted
on an interim basis to require the use of the new survey forms,
procedures and interpretive guidelines described above. The
current regulations providing certification survey forms and
guidelines, 42 C.F.R. Part 488, Subpart C, shall be suspended but
not repealed pending further orders of this Court . . . " HCFA
Attachment 2 at 1, 3. Thus, HCFA could not repeal Subpart C;
nevertheless, it was allowed by the court to use the new survey
protocols. Any alleged non-conformity with the requirements of the
APA on HCFA's part is therefore moot in light of the court's
interim order.
Accordingly, because Subpart C conflicts with the congressional
design underlying OBRA '87, it became void of any effect and
validity; it was rendered "a mere nullity" as a matter of law,
without necessitating a repeal or withdrawal by any formal means.
I find unpersuasive Petitioner's argument that HCFA has acted in
disregard of its own rules. Petitioner cites Morton v. Ruiz, 415
U.S. 199, 235 (1974), as well as other cases, for the proposition
that "[a]dministrative agencies are under an obligation to observe
their own regulations." P. Br. at 12. This general statement of
law cannot be disputed. But what Petitioner ignores is that such
general statement cannot be applied to circumstances where the
regulation in issue no longer carries out the will of Congress and
has been replaced by other administrative directives, such as SOM
250.
Here, HCFA has followed its regulations, procedures, and
precedents. Because Subpart C became null and void and, thus,
without any operative effect, HCFA's departure from this subsection
was justified. The order of remand issued by the Appeals Council
of the Social Security Administration in Health Care Financing
Administration v. Devon Gables Health Care Center (Dec. 7, 1994),
further supports HCFA on this point. In stating the background of
the case, the Appeals Council first explained that the
administrative law judge in the case had held that
the survey process and subsequent findings resulting therefrom
are invalid as a matter of law, given that [HCFA] did not follow
its own binding regulations
relating to the survey process, as contained in 42 C.F.R. Part
488, Subpart C.
HCFA Attachment 3 at 3. 18/
The Appeals Council concluded that the administrative law judge had
erred in finding the survey process and subsequent findings to be
invalid:
Under the Administrative Procedure Act, an Administrative Law
Judge is subordinate in matters of policy to the Secretary of
Health and Human Services. The Secretary, acting through the
Administrator of HCFA, determined that OBRA '87 and 42 C.F.R. Part
488, Subpart C are not consistent, and made the policy decision to
give effect to the pertinent provisions of OBRA '87 by means of
interpretive manuals, procedures and statements of policy which
have not been published as regulations. The Secretary further
determined to apply nationwide the September 27, 1990 Smith court
order which suspended 42 C.F.R. Part 488, Subpart C, and required
use of the unpublished forms, procedures and interpretive
guidelines in order to implement the changes mandated by OBRA '87.
HCFA Attachment 3 at 4.
The legal and factual basis of the remand order issued by the
Appeals Council is consistent with my analysis of this case. 19/
Further support for the position can be inferred from the fact that
the regulations found in this Subpart refer to other regulations
that are outdated and no longer exist. For example, as a result of
the numerous and substantial revisions to the regulations
concerning conditions of participation and other requirements
mandated by OBRA '87, the regulations referenced in the chart at 42
C.F.R. 488.115 were made inert by Congress and by HCFA's own
rule-making activities. These referenced regulations, which
pre-date OBRA '87, no longer have any viability, for they are no
longer in existence. (See fn 15 for a discussion of this chart.)
Having recognized that Subpart C was contrary to OBRA '87, the
Secretary thus chose to effectuate the OBRA '87 provisions by means
of "unpublished forms, procedures and interpretive guidelines." It
is noteworthy that the Appeals Council's reference to the
unpublished materials is a reference to the contents of Appendix P
of the State Operations Manual (250) and, also, the HCFA
Self-Instructional Manual. HCFA Attachment 3 at 2; see fn 18.
Thus, HCFA's use of the SOM 250 in place of the now-obsolete
Subpart C complied fully with the Secretary's policy decision and
was consistent with its obligation to abide by its own rules and
regulations. Accordingly, HCFA did not violate any administrative
norm by its non-adherence to the survey procedures and guidelines
contained in Subpart C. 20/
Furthermore, this case is distinguishable from Morton v. Mancari,
417 U.S. 535, 549 (1974), in which the Court, quoting Posadas v.
National City Bank, 296 U.S. 497, 503, (1936), stated that "repeals
by implication are not favored." In Morton v. Mancari, the Court
considered the issue of whether the Indian employment preference in
the Bureau of Indian Affairs contained in the Indian Reorganization
Act was impliedly repealed by the Equal Employment Opportunity Act
of 1972. As part of its analysis, the Court stated that "[i]n the
absence of some affirmative showing of an intention to repeal, the
only permissible justification for a repeal by implication is when
the earlier and later statutes are irreconcilable." Id. at 550.
The Court found that the employment preference was not impliedly
repealed by the 1972 Act.
Here, unlike Morton v. Mancari, the issue is not whether one
statute conflicts with another statute, but whether promulgated
regulations conflict with the intent of Congress as expressed in a
specific statute, namely, OBRA '87. As I discussed above, Subpart
C did not address or implement the new requirements contained in
OBRA '87 affecting nursing homes and the survey process. This
being the case, Subpart C was rendered void and without operative
effect. Using the analysis of Morton v. Mancari, the record
demonstrates that Subpart C is "irreconcilable" with the
requirements of OBRA '87 and is arguably repealed by implication.
Furthermore, HCFA, through the previously enumerated cited sections
in the Federal Register, made its position quite clear concerning
the applicability of Subpart C. Notice was given to SNFs that, in
implementing the federal requirements covering the conduct of
long-term care facilities, the Secretary no longer was relying on
the survey protocols and procedures set forth in Subpart C. I have
no authority to question that decision or second guess the
Secretary.
VI. Issue:
Whether SOM 250 is applicable to the survey ofPetitioner.
Petitioner contends that, to the extent that SOM 250 alters the
substance of Subpart C, HCFA was required to promulgate the
provisions of SOM 250 in accordance with the rulemaking
requirements of the APA; otherwise, such requirements would be
invalid. P. Br. at 17-20.
I do not agree that, because HCFA did not issue SOM 250 in the form
of a formal regulation, it is null and void . The provisions of
SOM 250 are not "substantive," but "interpretive". Alcarez
v.
Block, 746 F.2d 593, 613 (9th Cir. 1984); American Hospital
Association v. Bowen, 834 F.2d 1037, 1045 (D.C. Cir. 1987);
Guadamuz v. Bowen, 859 F.2d 762, 771 (9th Cir. 1988). HCFA
published SOM 250 to provide guidance to state surveyors who are
responsible for determining compliance by long-term care facilities
with federal requirements imposed by statute and regulations. The
following references in SOM 250 set forth HCFA's purpose in
disseminating this document to state agencies:
2712. USE OF THE SURVEY PROTOCOL IN THE SURVEY PROCESS
[Survey protocols] are the authorized interpretations of
mandatory requirements set forth in provisions of the Social
Security Act . . ., and in the regulations.
Survey protocols identify relevant areas and issues to be
surveyed as specified in each regulation, and, in some cases, the
methods to be used to survey those areas and issues. These
protocols promote consistency in the survey process. They also
assure that a facility's compliance with the regulations is
reviewed in a thorough, efficient and consistent manner. . .
Included in the survey protocols are Interpretive Guidelines
which serve to interpret and clarify the conditions of
participation, conditions for coverage, and requirements of
participation for specific types of entities. The Interpretive
Guidelines contain authoritative interpretations and clarifications
of statutory and regulatory requirements and are to be used to make
determinations about a provider's compliance with requirements.
These Interpretive Guidelines merely define or explain the relevant
statutes and regulations and do not impose any requirements that
are not otherwise set forth in the statute or regulations. . . .
*****
2803. SURVEY PROTOCOL
A. Introduction.-- This protocol is established pursuant to
1819(g)(2)(C) and 1919(g)(2)(C) of the Act to provide guidance
to surveyors conducting surveys of long-term care facilities
participating in the Medicare and Medicaid programs. The protocol
consists of survey procedures, work sheets and Interpretive
Guidelines. It serves to explain and clarify the requirements for
long-term care facilities and is required to be used by all
surveyors measuring facility compliance with Federal requirements.
The purpose of this protocol is to provide suggestions,
interpretations, check lists, and other tools for . . . use both in
the preparation for the survey and . . . onsite performing the
survey[.] These Interpretive Guidelines merely define or explain
the relevant statutes and regulations and do not impose any
additional costs or place other burdens on any health care
facility. (See 2712.)
HCFA Ex. 13 at 2-137, 2-183.
Since SOM 250 was not intended to "impose any requirements that are
not otherwise set forth in the statute or regulations," HCFA would
not need to formally publish these instructive guidelines to state
surveyors in the form of a regulation. Consequently, SOM 250 must
be read in connection with the statutory and regulatory provisions
regarding SNFs to determine the operative protocols, definitions,
and standards that were applicable at the time of the survey in
issue. I conclude that the appropriate approach is to review the
relevant statutory provisions, regulations, and interpretative
guidelines of HCFA as a whole in determining whether HCFA can
support the deficiencies cited in the Statement of Deficiencies,
i.e., HCFA 2567.
Petitioner would have me, as the adjudicator, alter the focus of
the hearing from whether deficiencies exist to whether the state
surveyors complied with the applicable survey protocols. The focus
of this hearing is on Petitioner's practices in operating its SNF
and whether those practices resulted in deficiencies arising from
the requirements of 42 C.F.R. Part 483, Subpart B, Requirements for
Long Term Care Facilities.
HCFA recognized that Congress, in enacting OBRA '87, did not intend
for survey procedures, in and of themselves, to be elevated above
surveyors' legitimate findings of deficiencies. HCFA states, "[t]o
invalidate legitimate determinations of noncompliance and leave
them unaddressed would be in opposition to the mandate of OBRA '87
that all requirements be met and enforced, and would lead to
inconsistent application of the law." 59 Fed. Reg. 56,133. To
allow deficiencies that are "otherwise well documented" to be
challenged and possibly invalidated merely because a surveyor did
not comply with "every last detail of the survey protocol" would,
in HCFA's view, "be surrendering all substance to form and would
clearly thwart Congressional will." Id.
Moreover, it is noteworthy that, although Petitioner vigorously
argues in its briefs that the surveyors acted in disregard of
proper survey procedures in adhering to the directives contained in
SOM 250, counsel for Petitioner had expressed the following opinion
at the in-person hearing:
Whatever HCFA instructed them to use, assume it was SOM 250,
whatever her boss, "her" being Ms. Downing's boss at the time,
instructed her to use, assume it was SOS [sic] 250, assume it was
a piece of toilet paper, it's irrelevant. The only standard by
which this case is going to be judge [sic] is whether or not the
2567 and whatever is being written up does or does not state
violations that amount to deficiencies within the meaning of 42
C.F.R. 540(N) [sic]. The fact that they internally either did or
didn't give correct instruction, they did or didn't perform an
adequate survey, it's immaterial. Either there's a violation
within the meaning of the regulation and proof that supports it or
there isn't. It doesn't make any difference if they were
instructed properly or improperly. We're not concerned with that.
We're only concerned here with whether or not the regulations have
been violation [sic], because that's what's set forth in the 2567,
and, if so, whether there's been any proof, among the other issues,
but that's all. There isn't any other standard. There's nothing
here in this 2567 about SOM 250.
Tr. 2134-2135.
In the quoted colloquy above, Petitioner contends, at length, that
whether or not the survey was performed adequately is "immaterial"
and that the only "standard" is whether or not the 2567 states
"violations that amount to deficiencies." Petitioner, by later
arguing in its briefs about the non-applicability of the SOM 250 to
the survey, attempts to have it both ways. While I disagree with
Petitioner as to the non-applicability of SOM 250 to this case for
the reasons I previously cited, I do agree that the ultimate
determination as to whether a deficiency exists will depend on the
contentions in HCFA 2567 and proof offered by the parties. As I
have discussed earlier in section IV.B of this decision, this
interpretation is consistent with HCFA's own interpretation of its
responsibilities in carrying out the congressional intent behind
the enactment of OBRA '87 and of the corresponding responsibilities
of SNFs who are or seek to be Medicare providers.
VII. Issue:
Whether 42 C.F.R. 489.13 permits HCFA to
denycertification on the date the survey iscompleted if all Level
A requirements are metand only Level B deficiencies exist.
The regulation at 42 C.F.R. 489.13 21/ states:
Effective date of agreement.
(a) All Federal requirements are met on the date of the
survey. The agreement will be effective on the date the onsite
survey is completed (or on the day following the expiration date of
the current agreement) if, on the date of the survey, the provider
meets all Federal health and safety conditions of participation or
Level A requirements (for SNFs), and any other requirements imposed
by HCFA.
(b) All Federal requirements are not met on the date of the
survey. If the provider fails to meet any of the requirements
specified in paragraph (a) of this section, the agreement will be
effective on the earlier of the following dates:
(1) The date on which the provider meets all
requirements.
(2) The date on which the provider submits a correction
plan acceptable to HCFA or an approvable waiver request, or both.
At issue in this case is the interpretation of this regulation.
The parties do not disagree that 42 C.F.R. 489.13 requires
Petitioner to be in compliance with Level A requirements on the
date of the survey. However, Petitioner contends that it is
virtually "impossible to be in 100 percent compliance with the
myriad regulations governing skilled nursing facilities." P. Br.
at 4. According to Petitioner, a single violation, such as a
"dirty plate, failed light bulb, unmade bed, late meal, or
documentation error, can all violate some regulation governing
skilled nursing facilities." Id. at 5. Therefore, Petitioner
argues that it is "inconceivable that [42 C.F.R.] 489.13 was
intended to require 100 percent compliance with "every single
regulation as a condition of certification." Id. As such,
Petitioner interprets 42 C.F.R. 489.13 as requiring that
Petitioner can be denied certification only when it fails to meet
a Level A requirement or, alternatively, when "the Level B
deficiencies are of a sufficient number or type so as to render the
facility in non-compliance with a Level A requirement." Id.
HCFA contends that the "any other requirements" language contained
in the regulation refers to Level B deficiencies, or for that
matter any other requirement imposed upon SNFs by regulation.
Accordingly, HCFA's position is that, under the regulation, it may
impose any additional requirement on SNFs as necessary to insure
the health and safety of the program beneficiaries. HCFA Br. at
13.
HCFA's position is supported by the plain meaning of the
regulation, as well as by regulations which were promulgated to
implement the OBRA '87 changes to requirements for SNFs. The plain
meaning of 42 C.F.R. 489.13 is that the phrase "any other
requirements" means just that. While the regulation does not
define what is meant by "any other requirements", Administrative
Law Judge Steven Kessel has interpreted the "any other
requirements" language to mean "all conditions, standards, and
elements established as prerequisites for certification."
Transitional Hospitals Corporation -- Las Vegas, DAB CR350, at 8
(1995). In other words, a provider must meet all requirements
imposed upon it by HCFA before it can be certified. Id.; SRA, Inc.
D/B/A St. Mary's Parish Dialysis Center, DAB CR341, at 5 (1992).
This interpretation is in accord with the plain meaning of the
regulation and is supported by the regulations that have been
promulgated to implement OBRA '87.
Petitioner argues that "[i]f HCFA intended that a provider was
required to meet every last regulation, irrespective of the
severity of the violation or the number, then it would have so
stated." P. Br. at 6. However, the explanatory material contained
in the preamble to the regulations that enacted 42 C.F.R. 489.13
contains comments on this very point.
Comment: Two commentors asked for further clarification of the
phrase "all Federal requirements are fully met" in 405.606(d).
22/ In particular, they asked whether "requirements" include
factors and elements which, though not met, do not put the provider
out of compliance with the pertinent standard.
Response: The final regulations have been revised to specify
that "all Federal requirements" includes the health and safety
requirements [conditions, standards, factors, and elements],
financial interest disclosure, and the civil rights provisions of
45 C.F.R. Parts 80, 84 and 90.
45 Fed. Reg. 22,933, 22,934 (1980).
Additionally, many regulations have been published subsequent to
OBRA '87 that unequivocally state that SNFs are required to comply
with each and every regulatory requirement. On February 2, 1989,
HCFA published final regulations (effective August 1, 1989, except
where specified otherwise) and solicited comments. 54 Fed. Reg.
5316 (1989). The regulations revised and consolidated the
requirements for long term care facilities (including SNFs). Id.
These regulations declared, in effect, that all regulatory
requirements were to be enforced to the fullest extent possible,
not just the more serious Level A type of deficiencies.
[W]e wish to be certain that the public realize that all
requirements for certification must be met by nursing facilities if
they are to avoid some measure of adverse action. We believe that,
to the extent that Federal requirements were set forth in what
appeared to be a qualitative hierarchy, that there might be some
misunderstanding that violations of the "lesser" requirements would
not be subject to Federal enforcement.
Additionally, the OBRA '87 requirements have recast
substantive requirements so as not to use the traditional
"conditions" and "standards" terminology.
Accordingly, in this final rule, we have attempted where
appropriate to retain the organization of the various proposed
requirements, but have revised the terminology. Thus, those
requirements that previously were identified as conditions of
participation (appearing as individual sections within a subpart)
are now designated as level A requirements. Those requirements
that previously were identified as standards (appearing as
individual paragraphs within a section) are now designated as level
B requirements. These designations are intended to communicate
that all of the nursing facility requirements are binding and are
not part of a qualitative hierarchy, while at the same time
recognizing that violations of these requirements (depending on
their type or severity) may be remedied through the different
enforcement mechanisms available to the Department.
54 Fed. Reg. 5317-5318.
In the preamble addressing the resident rights requirement, the
authors of the preamble stated that "Since we do not use the
"condition of participation" or "standard" terminology any
longer,
and we are committed to enforcement of all requirements equally, we
do not think the title used to describe resident rights will bring
about less or greater enforcement." 54 Fed. Reg. 5318-5319.
Emerging from these regulations, which were drafted as requirements
for long-term care facilities under OBRA '87, is a clear picture of
a mechanism of enforcement in which there is no hierarchy of
violations; that is, every violation that is committed by a
long-term care facility is to be taken seriously and is to provide
a potential basis for enforcement. This picture clearly accords
with HCFA's view of how the regulations are to be applied in this
case and does not accord with Petitioner's interpretation of the
regulatory requirements in 42 C.F.R. 489.13. Petitioner's
contentions that 42 C.F.R. 489.13 does not require 100 percent
compliance with every single regulation as a condition for
certification and permits HCFA to deny certification only when
Petitioner fails to meet a Level A requirement, or, alternatively,
when the "Level B deficiencies are of a sufficient number or type
so as to render the facility in non-compliance with a Level A
requirement" (P. Br. at 5), are without merit.
Further support for this position can be found in subsequent
preambles of the regulations implementing the OBRA '87 requirements
and published in the Federal Register. For example, as I discussed
earlier in section IV., in 1991, HCFA published final regulations
which revised and consolidated the 1989 regulations. 56 Fed. Reg.
48,826. These regulations were effective as of April 1, 1992.
In the preamble accompanying these regulations, HCFA reiterated
that long term care facilities, including SNFs, were subject to
enforcement for all violations of requirements and that "[i]t was
never intended that the Level A and Level B designations imply a
hierarchy of importance." 56 Fed. Reg. 48,827. The preamble text
went on to state that a long-term care facility (including an SNF)
must be in compliance with all the requirements of sections
1819(b) through (d) and 1919(b) through (d) in order to participate
in the Medicare and Medicaid programs.
Every requirement in these regulations must be enforced and
penalties must be assessed in accordance with regulations issued
pursuant to sections 1819(h) and 1919(h) of the Social Security Act
(The Act).
56 Fed. Reg. 48,827.
These regulations went one step further than their predecessor,
however, and actually eliminated the designations of Level A and
Level B. The preamble notes this change:
Comment: A number of commentors, especially those dealing with
resident activities and social services, objected to the Level A
and Level B designations used in the organization of these
requirements. Their principal objection centered around a belief
that Level B requirements were less important than Level A
requirements.
Response: In order to prevent any further confusion over this
issue, we have decided to delete from part 483 all references to
Level A and Level B requirements.
Id. 23/
Finally, as I discussed earlier, in 1992, HCFA published another
set of proposed regulations, which specified the process for
surveying SNFs under Medicare and NFs under Medicaid and for
certifying that these facilities meet federal requirements for
participation in Medicare and Medicaid. 57 Fed. Reg. 39278 (1992).
With regard to the conditions of participation that must be met by
prospective providers, the preamble for the 1992 proposed
regulations stated:
Specifically, we note that the Act, at sections 1819(a) and
1919(a), defines a skilled nursing facility and nursing facility,
respectively, as one which "* * * meets the requirements * * *
described in subsections (b), (c), and (d) of this section."
Similarly, the enforcement sections of the Act, at sections 1819(h)
and 1919(h), speak clearly to the need for remedial action if a
facility fails to meet "a" requirement or "any" requirement
set
forth in the Act.
We realize that this approach would be a marked contrast from
the current system in which facilities may be approved for program
participation with level B deficiencies as long as all level A
requirements are met. Congress, however, has removed this
flexibility from the survey and certification system by admonishing
the Secretary for having used a hierarchy of Federal requirements
(as are represented by condition, standard, and element levels) and
by removing the concept of "substantiality" from determinations of
compliance. What will be in place under sections 1819 and 1919 is
a "horizontal" system of requirements which obliges nursing home
providers to comply with all such requirements, not just a portion
of them.
We are fully cognizant that this approach to provider
certification is a stringent one, but one that we believe reflects
the plain language of the Act that Congress expects us to execute.
57 Fed. Reg. 39,282.
Again, HCFA reiterated its commitment to enforcing all requirements
for program participation, not just ones that rise to a certain
threshold level. Throughout the process of promulgating
regulations, HCFA has consistently interpreted OBRA '87 as
requiring compliance with all regulatory requirements.
Furthermore, as the quoted preamble language makes clear, any
deficiency with regard to any regulatory requirement can be
sufficient basis to deny certification to a facility.
The preamble language emphasizes that enforcement will not proceed
on a hierarchical or two-tiered basis. Instead, SNFs must be in
compliance with every regulatory requirement, and a deficiency with
regard to any regulatory requirement can provide sufficient basis
to deny certification. There simply no longer exists any
distinction between Level A and Level B requirements because every
violation is considered to be potentially sufficient to deny
certification.
Accordingly, the plain meaning, applicable case law and the Federal
Register preamble text cited above provide overwhelming support for
HCFA's position that the phrase "all other requirements" contained
at 42 C.F.R. 489.13 means that SNFs not only must meet all
requirements established by regulation, but that any violation of
the regulatory requirements can provide a basis to deny
certification. Petitioner's contention that it can only be denied
certification if found deficient with respect to Level A
requirements or, alternatively, if found to have Level B
deficiencies which are of sufficient number or type to constitute
non-compliance with a Level A requirement, is without merit. Any
deficiency can form the basis to deny certification.
VIII. Issue:
Whether failure to meet the 10-day requirementcontained
in 42 C.F.R. 488.110(j) can be usedto alter the requirements of
42 C.F.R. 489.13.
Petitioner takes several stances regarding the date on which it
claims HCFA should have certified its facility. Initially,
Petitioner contends that it should be certified effective December
23, 1993, because that was the date that HCFA completed the survey
of Petitioner and conducted the exit conference. P. Br. at 1-2.
In sum, there is no evidence that Petitioner met all federal
requirements by the completion date of the survey; therefore, its
certification can only be the earlier of the date on which it met
all requirements or the date when it submitted an acceptable plan
of correction or approvable waiver request to HCFA. 24/ 42 C.F.R.
489.13.
Secondly, Petitioner contends that it should be certified effective
January 12, 1994. P. Br. at 9, 21. As support for its position,
Petitioner cites the regulation found at 42 C.F.R. 488.110(j)
which directs surveyors to "In accordance with your Agency's
policy, present the Statement of Deficiencies, form HCFA-2567, on
site or after supervisory review, no later than 10 calendar days
following the survey." Ten calendar days from December 23, 1993 is
January 2, 1994. Petitioner contends, however, that HCFA did not
have the HCFA 2567 ready until January 22, 1994. P. Br. at 21. 25/
Allowing for an extra day for the fact that January 2, 1994 was a
Sunday, Petitioner contends that HCFA violated the regulation by
failing to provide Petitioner with the survey results within 10
calendar days following the survey. Petitioner avers that had HCFA
provided it with the HCFA 2567 within 10 calendar days as directed
by regulation, Petitioner would have submitted a plan of correction
on January 12, 1994.
Petitioner therefore contends that it was HCFA's delay in providing
it with the HCFA 2567 that prevented it from submitting its plan of
correction before January 31, 1994. Accordingly, Petitioner
requests that I find that it met the requirements of participation
as of January 12, 1994, the date upon which it claims it would have
submitted its plan of correction had HCFA provided it with HCFA
2567 within 10 days of the exit conference.
Admittedly, Petitioner did not get the HCFA 2567 until January 19,
or 22, 1994. I cannot speculate as to when Petitioner would have
submitted the plan of correction had HCFA been able to provide
Petitioner with the HCFA 2567 within the ten days after completion
of the survey.
The regulation at 42 C.F.R. 489.13 is clear on its face. Once
HCFA, via a survey, finds a facility has deficiencies, that
facility cannot be certified until it meets all requirements or
submits an acceptable plan of correction (or an approvable waiver
request), whichever date is earlier. Where there has been no
evidence presented of correction of the deficiencies, Petitioner
can be certified only upon submission of an acceptable plan of
correction. 42 C.F.R. 489.13; SRA, Inc., DAB CR341, at 5;
Transitional Hospitals Corp., DAB CR350, at 8.
Moreover, although Petitioner's arguments may be based on
fundamental fairness, I do not have the authority to equitably
split the difference or fashion a remedy based on HCFA's
non-compliance with the 10-day requirement. More importantly, I do
not have the authority to find the regulations ultra vires the Act,
which is what I would have to do in order to grant Petitioner the
relief it seeks.
As an essential and necessary step toward granting Petitioner the
relief it is seeking, I would first have to ignore the explicit
directive of the regulations, which states that, absent evidence of
correction of the deficiencies, Petitioner can be certified only
upon HCFA's receipt of an acceptable plan of correction. 42 C.F.R.
489.13(b)(2). My authority to hear and decide this case simply
does not give me the leeway to ignore regulatory provisions.
Moreover, the provision that, according to Petitioner, mandates to
HCFA to provide the facility with HCFA 2567 within 10 calendar days
is phrased in terms of the agency's policy. 42 C.F.R.
488.110(j). The provision contains the words "in accordance with
your agency's policy." Neither 42 C.F.R. 488.110(j) nor any
other provision in this section contains any penalty provision for
the agency's failure to comply with this 10-day requirement.
Additionally, as I stated in section IV. of this decision, Subpart
C of 42 C.F.R. Part 488, of which 42 C.F.R. 488.110(j) is a
subsection, has been rendered inoperative by the nursing home
reform provisions of OBRA '87. As I have already noted, not only
does the legal underpinning for Subpart C no longer exist, but
Subpart C is inconsistent with the OBRA '87 provisions and, indeed,
has been replaced by new survey protocols implemented by HCFA to
carry out the congressional mandate of OBRA '87.
These factors, coupled with the mandates contained at 42 C.F.R.
489.13, favor an interpretation of the alleged 10-day "requirement"
as a goal which HCFA should strive to meet in all cases, but not as
something which should either invalidate the survey or mandate that
HCFA grant the SNF an earlier certification date than it was given,
in cases where this goal is not met. In short, there is no
provision in 42 C.F.R. 489.13 to respond to situations where
HCFA delays transmittal of the form 2567 to a SNF.
Petitioner would have me act in such a way as to void a regulation
that is still in effect in favor of a provision that is contained
in a subpart which has been rendered inoperative by law and which,
by its very language, is merely a guideline. I am unable to do so,
and accordingly, find that the 10-day "requirement" contained in 42
C.F.R. 488.110(j) is not controlling here. To find otherwise
would be contrary to the regulations and would also be outside of
my delegated authority.
IX. Issue:
Whether the surveyors' use of a case-mixstratified sample
was in accordance with thelaw.
Petitioner argues that the surveyors were required to use the
selection methodology described in 42 C.F.R. 488.110(d) in
selecting the resident sample to be reviewed. P. Br. at 10.
Petitioner contends that the surveyors did not select the residents
in a random manner nor did they comply with the other requirements
of this regulation. Id. at 8, 10-11. 26/
HCFA argues that the Act, as amended by OBRA '87, requires
surveyors to use a "case-mix stratified sample" of residents. 42
U.S.C. 1395i-3(g)(2)(A)(ii) and 1396r(g)(2)(A)(ii). HCFA Rep.
Br. at 34. HCFA contends that, as a result of implementation of
the OBRA '87 requirements, this sampling methodology superseded the
random sampling approach described in Subpart C and is thus the
correct one to be used. Id.
The OBRA '87 requirement concerning resident sampling, which is
codified at 42 U.S.C. 1395i-3(g)(2)(A)(ii) and
1396r(g)(2)(A)(ii), states, "Each standard survey shall include,
for a case-mix stratified sample of residents . . . ." (emphasis
added). The term "case-mix stratified sample" is not defined.
However, I have examined SOM 250 and found that it contains
detailed instructions and guidance to enable surveyors to carry out
"case-mix stratified sampling". HCFA Ex. 13 at P-9 -P-12. The SOM
250, in a section titled "Task 4 - Resident Sampling", states:
"The general objective is to select a case mix stratified sample of
residents for the Standard Survey to conduct Individual Resident
Rights, Quality of Care, Environmental Quality and Dining
Assessments." HCFA Ex. 13 at P-9. The SOM 250, under a subheading
titled "Case-mix Categories", lists four case-mix categories, and
gives a description of the type of resident who would fall in each
category. Id. The four categories are the following: case-mix
group A -- "Light Care" residents; case-mix group B -- "Heavy
Care"
residents; case-mix group C -- "Non-interviewable light care"; and
case-mix group D -- "Non-interviewable heavy care". The SOM 250
gives surveyors guidance in how to select the resident sample and
lists various factors to be considered in the selection process,
such as residents with physical restraints, special resident care
needs, residents with complex or multifaceted problems requiring
interdisciplinary interventions, and residents with psychosocial,
interactive, and/or behavioral dysfunction. Id. at P-10. To
determine the minimum sample size, SOM 250 refers the surveyors to
a table. HCFA Ex. 13 at P-9, P-11.
As I stated earlier, 42 C.F.R. 488.110(d) ("Task 2 -- Resident
Sample -- Selection Methodology") refers to a random sample.
Specifically, this subsection states:
This methodology is aimed at formulating a sample that
reflects the actual distribution of care needs/treatments in the
facility population. Primarily performed on a random basis, it
also ensures representation in the sample of certain care needs and
treatments that are assessed during the survey. . . . After
determining the appropriate sample size, select residents for the
sample in a random manner. (emphasis added).
This section on resident sampling ends with the following
statement: "Always keep in mind that neither the random selection
approach nor the review of residents within the specified care
categories precludes investigation of other resident care
situations that you believe might pose a serious threat to a
resident's health or safety. Add to the sample, as appropriate."
42 C.F.R. 488.110(d).
As I previously stated, Subpart C, which describes random sampling,
does not conform to the case-mix stratified sampling requirement of
OBRA '87 (and codified at 42 U.S.C. 1395i-3(g)(2)(A)(ii) and
1396r(g)(2)(A)(ii)). I find that the implementation of OBRA '87
ushered in a new selection methodology and resulted in the demise
of the approach provided for in 42 C.F.R. 488.110(d). The
appropriate and correct methodology to be used, since the enactment
of OBRA '87, is the case-mix sampling approach, which is elaborated
upon in SOM 250.
Congress, by expressly referring to case-mix stratified sampling in
OBRA '87, intended that this methodology be used by surveyors once
OBRA '87 became effective. In the legislative history of OBRA, the
congressional committee states, "The surveyors should be allowed to
spend as much time as they deem necessary to properly survey a
statistically significant case-mix stratified sample of residents
to determine compliance with the requirements contained in this
bill." H.R. Rep. No. 391, 100th Cong., 1st Sess., pt. 2, at 939
(1987).
Based on the testimony of HCFA's witnesses, there appears to be no
dispute that the surveyors in this case followed the instructions
contained in SOM 250 in determining the resident sample and, thus,
used a case-mix stratified resident sample. Nelson Ford, a health
facilities evaluator supervisor employed by the DHS, testified that
the surveyors followed the resident sample selection table in SOM
250. Tr. 1648-1650. When asked how to proceed when a provision in
SOM 250 conflicts with the applicable regulation, he testified that
"[they] follow the SOM 250." Tr. 1662. Mr. Ford stated that there
did exist "a rule that tells you how to sample or the number in
which -- of those patients falling within those categories", and
that this instruction is set forth in SOM 250. Tr. 1670.
Another witness, Ruth Patience, who is a HCFA survey and
certification review specialist, testified that SOM 250 gives
instructions on the subject of sampling and that the sampling
methodology described beginning on page P-9 of SOM 250 "is the
methodology that we expect the state agency surveyors to use when
choosing their resident sample". Tr. 2450, 2456. Ms. Patience
stated that this methodology was in effect in December 1993. Tr.
2456.
I find that the surveyors' use of a case-mix stratified sample was
in accordance with the law. The surveyors' adherence to the
sampling instructions and guidance contained in SOM 250, which
amplified the case-mix sampling methodology required by the Act,
was neither improper nor irregular. Their course of conduct did
not violate any rights of Petitioner.
X. Issue:
Whether any of the following allegeddeficiencies as set
forth in the HCFA 2567 wereproven.
The SOM 250 defines deficiency for the purposes of determining
whether Petitioner was in compliance with the standards for
participation as a Medicare provider. Petitioner contends that the
definition of what constitutes a deficiency, i.e., what is the
threshold for determining whether a deficiency exists, differs
depending upon whether 42 C.F.R. 488.110 or SOM 250 is
controlling. I have determined that the provisions of SOM 250 are
the applicable criteria to follow in determining whether a
deficiency has been established. In accordance with that finding,
it will be useful to review such guidelines before I analyze each
of the deficiencies cited by the surveyors in the HCFA 2567
pertaining to Petitioner.
The SOM 250 contains the following definition:
. . . D. Criteria.--To determine if a level B deficiency
exists, use the following definitions:
o A "deficiency" is noncompliance with a regulatory
requirement. A deficiency may be cited if there are situations
identified during the course of a survey of sufficient severity
and/or frequency that indicate an individual requirement is not
met.
o "Frequency" means the incidence or extent of the
occurrence of an identified situation in the facility. The
situation can affect a single resident or several residents.
o "Severity" means the seriousness of the identified
situation (e.g., the degree to which the problem compromises the
resident's health and safety, or fails to achieve the highest
practicable level of physical, mental, and psychosocial
well-being).
For all requirements, the threshold at which the
frequency or severity of occurrences amounts to a deficiency varies
from situation to situation. One occurrence directly related to a
life-threatening or fatal outcome or high potential for such an
outcome may be cited as a deficiency including a determination of
immediate and serious threat.
HCFA Ex. 13 at P-29.
The SOM 250 provides additional guidance as follows:
The following three sections contain guidance on using the
information gained concerning Environmental Quality, Dining,
Quality of Care Assessment, and Residents Rights Assessment.
E. Decisions Concerning Environmental Quality and Dining.--
When making decisions regarding compliance with those requirements
reviewed during the EQA and dining observation, use the following
guidelines:
o Review all worksheets and documentation or "B" and "C"
ratings. Consider the actual circumstances, i.e., your
observations and interview information, that caused each "B" and
"C" rating.
o Make your compliance decisions based on the frequency
or severity of the combination of ratings for each tag number. For
example, for a specific tag, there may be 15 observations, with 11
"A" ratings, 3 "B" ratings and 1 "C" rating. Do
not determine that
a deficiency exists solely because there was 1 "C" rating or four
negative ratings. Rather, make your determination based on the
documented circumstances that represent the frequency or severity
necessary to substantiate non-compliance.
F. Decisions Concerning Quality of Care Assessment.--Again
consider your observations in the context of frequency and
severity. In determining the severity of a situation, consider
negative resident outcomes, i.e., the impact of the facility's
deficient practice on the resident.
For all sampled residents, a negative resident outcome which
you determine was avoidable, i.e., due to the facility's actions or
lack of action, and not due to the resident's clinical condition,
or exercise of his or her rights, provides strong evidence of
noncompliance. Negative outcomes related to quality of care
generally fall into three categories:
o Physical, mental or psychosocial deterioration (e.g.,
development of, or worsening of, a pressure sore, insertion of an
indwelling catheter when the resident was admitted to the facility
without one, loss of dignity lying in a urine saturated bed for a
prolonged period, social isolation caused when staff fail to assist
the resident to participate in scheduled activities).
o Lack of reaching the highest practicable level of
physical, mental or psychosocial well-being. No deterioration
occurred, but the facility failed to provide necessary care for
resident improvement. For example:
- The facility identified the resident's desire to
reach a higher level of ability, e.g., improvement in ambulation,
and care was planned accordingly. However, the facility failed to
implement, or failed to consistently implement, the plan of care,
and the resident failed to improve, i.e., did not reach his/her
highest practicable well-being;
- The facility identified a problem/need in the
comprehensive assessment, e.g., the resident was
withdrawn/depressed, but did not care plan for it or prioritize it
to address it at a later time. The resident received no care or
treatment to address the problem/need and did not improve, i.e.,
remained withdrawn/depressed. Therefore, the resident was not
given the opportunity to reach his/her highest practicable
well-being; or
- The facility failed to identify the resident's
need/problem/ability to improve, e.g., the ability to eat
independently if given assistive devices, and therefore, did not
care plan. As a result, the resident failed to reach his/her
highest practicable well-being, i.e., eat independently.
o A strong potential for harm. This may be identified
when an observed facility practice is so divergent from accepted
principles of practice that a future negative outcome or harm is
probable. For example, nurse aides in a facility often do not wash
their hands between caring for residents, including those times
that they change a bed soiled with feces. Although there has been
no evidence of a high facility infection rate, or of spread of
infection from one resident to another, if a resident contracts an
infection or becomes colonized with a highly contagious bacteria,
there is a high potential for a major outbreak of nosocomial
infection.
HCFA Ex. 13 at P-29 - P-30.
As shown above, SOM 250 directs the surveyor to analyze the
frequency and severity of noncompliance with regulatory
requirements and to make determinations as to whether the facility
is in compliance with an individual requirement by assessing the
frequency or severity of the alleged violation.
Specifically, SOM 250 directs the surveyor to take into account
negative resident outcomes. It provides flexibility in guiding
surveyors in what constitutes a deficiency and acknowledges that a
deficiency is a very situation specific occurrence. In short, a
deficiency can occur when there is evidence of noncompliance with
a regulatory requirement in 42 C.F.R. 483, and the noncompliance
has a serious negative impact on the resident or residents, such as
harm or a strong potential for harm. Examples of negative outcomes
include situations where the resident's health and safety has been
compromised, or where the facility failed to enable the resident to
achieve his or her highest practicable level of physical, mental or
psychosocial well-being.
A. Issue: Whether HCFA provided adequate notice to Petitioner of
the underlying facts of the deficiencies cited in the HCFA 2567.
At various times throughout the hearing and in its briefs,
Petitioner contended that HCFA had taken a "moving target/shell
game" approach in presenting its case. P. Br. at 44-45, 79; see P.
Resp. Br. at 21. For example, with respect to F 272, Petitioner
complained of the "vague, uncertain and inappropriate nature [sic]
manner in which this deficiency was set forth." P. Br. at 44-45.
Petitioner stated further:
It is not possible to defend against claims of which
petitioner had no notice and when such claims are disclosed, then
become subject to repeated changes. Petitioner repeatly [sic]
referred to this approach as a "shell game." The Administrative
Law Judge repeatedly rejected the accusation. Whatever the label,
it is not fair to require petitioner to have to guess at what it is
supposed to be defending against. This, by itself, disqualifies
this deficiency as part of any basis for failure to certify.
P. Br. at 45.
I do not agree with Petitioner's characterization that HCFA took a
"moving target/shell game" approach. The HCFA 2567 sets forth the
alleged deficiencies which were identified by the surveyors during
the survey. The surveyors testified concerning the underlying
facts supporting the deficiencies cited in the HCFA 2567. In
instances where a surveyor's testimony with respect to a particular
deficiency was unclear or confusing, I ascribed as much weight to
that testimony as was appropriate. I did not consider allegations
in the HCFA 2567 against which Petitioner could not adequately
defend due to a lack of specificity or notice. Further, in
instances where HCFA did not prove a certain allegation, I have so
indicated.
B. Set out below, in relevant part, is the statement in the HCFA
2567 concerning the alleged deficiency identified as F 221 (HCFA
Ex. 2 at 1-2):
42 C.F.R. 483.13 (a) (a) Restraints. The resident has the
right to be free from any physical or chemical restraints imposed
for purposes of discipline or convenience, and not required to
treat the resident's medical symptoms [.]
*****
Based on record review and observation[,] the facility failed
to provide each resident the right to be free from physical
restraint.
Findings include:
Resident 16 was assessed by licensed staff as wandering and
attempting to climb out of bed. A vest restraint was ordered
5/13/93, and continues to be used, restricting her to a wheelchair
during the day. Her ability to ambulate has declined and the
facility has failed to adequately assess use of less restrictive
restraints, or the possibility of discontinuation of the restraint,
if staff was more focused toward maintaining or improving her
independence in ambulation.
Resident 16 was admitted to Petitioner's facility on May 1, 1993.
P. Ex. 1 at 1. A physician's order dated May 12, 1993, mandates
the use of a vest restraint on Resident 16 at all times for safety
and proper body alignment. P. Ex. 1 at 3. The 90-day and 180-day
assessments show that the order for Resident 16 to be restrained in
a vest restraint was in place through the time HCFA completed its
survey of Petitioner on December 23, 1993, over seven months after
the physician's initial order. P. Ex. 1 at 1-4; P. Ex. 27 at 1-7.
27/
At the hearing, Ms. Cox testified that she saw Resident 16 on more
than one occasion during the survey and that, each time, the
resident was confined in a vest. Tr. 1003-1004, 1023. Ms. Cox
testified that she found no evidence that Resident 16 had ever been
considered for a less restrictive restraint other than a vest
because there was nothing in the resident's record to indicate that
Resident 16 was ever assessed at any time to determine if some
lesser restraint could be used, or if any restraint were necessary.
Tr. 2463-2464.
The rehabilitation screen supports HCFA's position because the
screen has a specific line for stating the reasons for using any
physical restraint. P. Ex. 1 at 4. The line on Resident 16's
rehabilitation screen is blank. P. Ex. 1 at 4. According to HCFA,
reevaluation of the use of a restraint is critical to the health
and well-being of patients because "[a]nytime a person is
immobilized it's going to decrease their strength and their ability
to walk and use their muscles . . . they're going to get weaker."
Tr. 1020.
In support of HCFA's contention that the resident should be
reassessed periodically to determine whether a less restrictive
alternative would be feasible, Ms. Patience testified that it is
important that
the restraint not be used for discipline or convenience. We
survey for that by looking for whether or not less restrictive
measures were used before the restraint was applied and whether or
not there was an assessment . . . Less restrictive means that the
facility has tried other methods . . . .
Tr. 2464.
At issue in this deficiency is whether Petitioner violated the
requirement at 42 C.F.R. 483.13(a) (F 221) by failing to
adequately assess Resident 16 for the use of less restrictive
restraints. SOM 250 provides specific guidance for SNFs regarding
the need for documenting that the facility has considered less
restrictive alternatives to restraints:
When coupled with appropriate exercise, therapeutic
interventions such as pillows, pads, or removable lap trays, are
often effective in achieving proper body position, balance and
alignment, and preventing contractures without use of restraints.
Attention to individual, mental, physical and psychosocial needs,
meaningful activity, environmental changes, and aggressive nursing
rehabilitation or restorative programs are other examples of less
restrictive methods of meeting resident needs. If the restraint is
used to enable the resident to attain or maintain his or her
highest practicable level of functioning, a facility must have
evidence of consultation with appropriate health professionals,
such as occupational or physical therapists. This consultation
should consider the use of less restrictive therapeutic
intervention prior to using restraints. . .
The use of therapeutic interventions must be justified through
the care planning process and demonstrate that these interventions
promote the care and services necessary for the resident to attain
or maintain the highest practicable well-being. . . .
The decision to apply physical restraints should be based on
the assessment of each resident's capabilities, an evaluation of
less restrictive alternatives and the ruling out of their use. The
plan of care should also contain a schedule or plan of
rehabilitative training to enable the progressive removal of
restraints or the progressive use of less restrictive means, as
appropriate. This systematic approach assures that restraints
would not be applied for purposes of discipline or convenience and
only to enable treatment of medical symptoms.
HCFA Ex. 13 at P-76 - P-77.
Ms. Patience stated that any resident who was being subjected to a
vest restraint should have, in his or her medical record, evidence
showing that less restrictive restraints had been considered. Tr.
2485-2486. Ms. Patience testified further that such evidence might
be documented in the therapy notes, nurses' notes, physicians'
notes, or social services notes. Tr. 2486. According to Ms.
Patience, in light of SOM 250, such evidence would need to
demonstrate
an assessment of the resident's mobility, cognition, vision,
and any other less restrictive measures that were used; how long
they were used for; and what the results of the use of those less
restrictive measures were.
Tr. 2487.
I find credible the testimony of Ms. Patience which indicates that
there should be documentation in the record to reflect that less
restrictive alternatives to a vest restraint were attempted or at
the very least, considered for this resident. Tr. 2486-2487. Her
testimony is supported by the plain meaning of the regulation and
the guidance contained in SOM 250, as noted above.
However, Petitioner attempts to attack HCFA's finding of deficiency
by contending that there is no evidence that resident 16 spent all
of her time in a vest restraint in a wheelchair, since the surveyor
was not present at all times. Additionally, Petitioner contends
that medical records establish that Resident 16 was not constantly
restrained in a vest restraint. P. Br. at 24-25. These
contentions are not germane to the issue at hand, because the issue
with regard to this deficiency is whether Petitioner ever
considered resident 16 for less restrictive alternatives to the
vest restraint, not whether resident 16 was under restraint at all
times.
Petitioner contends also that the evidence does not lend support to
HCFA's finding that Petitioner was deficient with regard to F 221
because resident 16's chart reflects that: 1) a physician ordered
the use of the vest restraint for Resident 16 and repeated the
order every 30 days; 2) the staff recommended to the physician that
resident 16 wear a safety belt at all times; 3) the
interdisciplinary team agreed with the use of the vest restraint at
all times; and 4) the continued use of the vest restraint was
considered on a quarterly basis. P. Br. at 25.
This dispute, simply stated, is whether Petitioner is required to
document that a less restrictive restraint was considered for
resident 16. Petitioner argues that there exists no regulation or
other requirement to compel Petitioner to document why a lesser or
different restraint should not be used when a physician has
explicitly ordered a specific type of restraint for a resident. P.
Br. at 25.
Petitioner contends that, to the extent it is required to examine
why resident 16 continued to need a vest restraint, such
examination was undertaken by the interdisciplinary team. P. Br.
at 29. Moreover, Petitioner contends that neither SOM 250 nor the
regulation can be read to require the substance of the subjects
discussed by the interdisciplinary team to be set out in writing.
According to Petitioner, the fact that the interdisciplinary team
approved the use of the restraint is sufficient to satisfy the
regulatory requirements. P. Br. at 31. Distilled to its essence,
Petitioner's argument on this issue is that the repetition of a
physician's order and the repeated approval of the
interdisciplinary team suffice.
Petitioner's arguments on this issue are not supported by the
record because the record contains nothing which would indicate
that the interdisciplinary team ever considered less restrictive
alternatives. While there is a repeated note from the
interdisciplinary team to use a vest restraint on resident 16,
there is nothing in the record to establish that this was anything
more than an approval of what had been done before. P. Ex. 1; P.
Ex. 27 at 6, 22. Even assuming arguendo that it was medically
appropriate to treat resident 16 by placing her in a vest restraint
at all times, the issue remains whether Petitioner satisfies the
statutory and regulatory mandate that the resident has a right to
be free from restraint. The statutory and regulatory framework,
the language of the regulation, and the guidance contained in SOM
250 all support that it is incumbent upon Petitioner to document
that the restraint was necessary for the patient's medical or
safety needs. These same factors further mandate that it is also
incumbent upon Petitioner to show that less restrictive
alternatives were attempted or at least considered.
Without such information, Petitioner did not prove that it ever
considered less restrictive alternatives for resident 16 because
the evidence HCFA has offered is persuasive, credible, and
unrebutted. I find that Petitioner's reliance on the mere
repetition of an order that resident 16 be restrained is
insufficient, given the requirements of OBRA '87 and SOM 250.
I find that HCFA has proven that Petitioner was in violation of the
regulatory requirement set forth at 42 C.F.R. 483.13(a) with
respect to resident 16. The regulations require more from
Petitioner than merely a repeated order that the resident be
restrained. While there are notations that indicate that resident
16 was initially placed in a restraint for reasons of safety and
proper body alignment, there is nothing in the record from which I
can conclude that Petitioner ever considered the resident for a
less restrictive restraint. P. Ex. 1 at 2, 22; P. Ex. 27.
Ensuring that residents are restrained only to the extent
absolutely necessary for their medical well-being or safety was of
paramount concern to the authors of the law and the regulations.
H.R. Rep. No. 391, 100th Cong., 1st Sess., part 1, at 932 (1987).
They expressed a legitimate concern that restraints were being used
merely for the convenience of the facility and in ways that were
detrimental to the residents. The regulations mirror this concern.
It is this interest and concern of Congress that places a duty on
Petitioner to justify the use of a particular type of restraint on
resident 16 and to demonstrate that a less restrictive alternative
was considered and found inappropriate in light of this resident's
condition. It was incumbent upon Petitioner to document that its
decision to continually restrain resident 16 in a vest restraint
was not a mere rubber stamp, but a decision that actually
considered less restrictive alternatives. The record in this case
fails to establish not only that less restrictive restraints were
used on resident 16, but that less restrictive restraints were even
considered for resident 16.
Moreover, based on the evidence of record and applying the SOM 250
guidelines, I conclude that, without adequate documentation that
other less restrictive alternatives were not available, placement
of resident 16 in a vest restraint could result in a potential
negative outcome. Accordingly, I find that the record more than
adequately supports that Petitioner was in violation of the
regulatory requirement set forth at 42 C.F.R. 483.13 with
respect to resident 16.
C. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 262 (HCFA Ex. 2 at 2-3):
42 C.F.R. 483.15(h)(3) (3) Clean bed and bath linens that are
in good condition;
*****
Based upon observation of residents rooms it was determined
that furniture was in need of cleaning.
Findings include:
During tour of the facility, interviews, and room visits, it
was noted that overbed tables and bedside cabinet tops had food and
liquids [sic] rings indicating a lack of daily cleaning of the room
furniture.
At the hearing, Ms. Shekell testified that an inadvertent
typographical error occurred in the HCFA 2567 when the she
apparently mistyped "F 262" on her lap-top computer instead of "F
261." The computer is programmed by HCFA to automatically display
the applicable regulatory citation that corresponds to the "F"
number entered.
Ms. Shekell testified that "262 addresses primarily linens, whereas
261 is sanitary cleanliness." Tr. 116.
The corresponding regulatory citation for "F 261", according to Ms.
Shekell and the SOM 250, is 42 C.F.R. 483.15(h)(2). Tr. 121;
HCFA Ex. 13 at P-96 - P-97.
A reading of the pertinent regulations suggests that the correct
citation could have been either 42 C.F.R. 483.15(h)(1), which
states: "A safe, clean, comfortable, and homelike environment,
allowing the resident to use his or her personal belongings to the
extent possible" or subsection (h)(2), which states: "Housekeeping
and maintenance services necessary to maintain a sanitary, orderly,
and comfortable interior." In my opinion, subsection (h)(2) is the
most appropriate subsection for the deficiency cited.
Petitioner argues that, based on HCFA's failure to cite the correct
regulatory citation, it was not given adequate and proper notice of
the deficiency to enable it to prepare a defense. It further
argues that, due to such failure, HCFA should be estopped from
proving the existence of this deficiency. Moreover, Petitioner
contends that the facts cited do not constitute a violation of the
regulation, and there is a failure of proof of violation. Tr.
116-120; P. Br. at 33-35.
In response, HCFA states that the deficiency was correctly cited in
the HCFA 2567 and Petitioner has had access to that document for
over a year prior to the hearing. In addition, HCFA asserts that
Petitioner addressed the cited deficiency when it submitted its
plan of correction. Tr. 118; HCFA Br. at 22.
When this issue was first raised at the hearing, I expressed my
concern that Petitioner's due process rights be protected. I
allowed testimony on the cited deficiency with the admonition that
I would rule on Petitioner's arguments after reading the parties'
posthearing briefs. After fully considering the notice issue, I
conclude after examining HCFA 2567 that Petitioner received
adequate notice of the deficiency even considering the incorrect
reference to the regulations. The applicable regulations are a
matter of public record and were available to Petitioner at the
time of the survey. To allow Petitioner to adequately defend
against this deficiency, HCFA 2567 needed to set out the facts the
surveyor found that supported her determination that a deficiency
was present. Petitioner was presented with those facts. The cited
regulation clearly did not apply to the deficiency cited, and
Petitioner could easily have ascertained knowledge of the correct
regulation or regulations by making reference to them. There is no
evidence that Petitioner was incapable of responding to this
deficiency in its plan of correction or at the hearing. Therefore,
I conclude that Petitioner's due process rights were not impaired
by HCFA's inadvertent reference to the wrong regulation when citing
this deficiency in the HCFA 2567.
Ms. Shekell testified that her observation of the cited deficiency
was based on her daily tour of Petitioner while conducting the
survey:
I noted that particularly over-bed tables were not well
cleaned; they had rings. And I would never cite if there was just
one or two that a patient had just been fed or if fluid had just
been s[e]t down and rings from something like that just on a few
tables. This was pervasive throughout room after room.
Tr. 122.
Petitioner objected to this testimony because it allegedly went
beyond the parameters of the cited deficiency when Ms. Shekell
testified that the deficiency was "pervasive" throughout the
facility. Petitioner's counsel argued that HCFA should be limited
to the allegations specifically written in the HCFA 2567. Tr.
123-126. As to the observations of Ms. Shekell, Petitioner
responds that "[t]here was no testimony as to how many days she
was in the facility, how often she observed the tables, any
investigation as to how long the liquid rings on the over[-]bed
tables had been there, any facts to indicate that they had been
there an inordinate length of time to indicate a lack of cleaning
or any facts other than . . . self-serving speculation . . . ." P.
Br. at 34. In contrast, Petitioner pointed out that Ms. Downing
testified that the facility was cleaned daily and over-bed tables
were cleaned after each meal if the resident ate in bed and spilled
his or her meal. Petitioner argued further support for Ms.
Downing's testimony could be found in Petitioner's Housekeeping
Department policies. P. Br. at 34; Tr. 1750-1751; P. Ex. 2 at 1.
I find unpersuasive Petitioner's argument that Ms. Shekell's
testimony went beyond the deficiency cited. With respect to this
deficiency, the HCFA 2567 indicates that "[b]ased upon observation
of residents rooms it was determined that furniture was in need of
cleaning." HCFA Ex. 2 at 2. Moreover, the surveyor noted the
unclean surroundings "[d]uring tour of the facility, interviews,
and room visits." Id. Thus, the HCFA 2567 on its face indicates
that the observation was not based on an isolated observation but
on a pattern of sightings that occurred during Ms. Shekell's
inspection of the facility. This is consistent with her testimony.
Petitioner's counsel was advised at the hearing that he had the
opportunity through cross examination to test the validity of Ms.
Shekell's observations. This he chose not to do.
Despite the testimony of Ms. Downing and reference to housekeeping
policies requiring daily cleaning of resident rooms, including
over-bed tables, Petitioner offered no witness who was present
during the survey who specifically contradicted the observations of
Ms. Shekell. The only evidence offered was Ms. Downing's testimony
and the housekeeping policy. Such evidence is not reliable or
probative as to whether Ms. Shekell's observations were accurate.
Ms. Downing was not employed by Petitioner at the time of the
survey, nor was she present during the survey. Nor is there any
testimony from anyone who was employed at the facility at the time
of the survey that the housekeeping polices were in fact followed
during the period of the survey. If it exists, such evidence would
have been available to Petitioner. Its absence suggests that
Petitioner cannot directly contradict the findings of the State
surveyor.
Therefore, when I review the record as a whole, the testimony of
Ms. Shekell concerning her findings supporting this deficiency are
amply supported and establish the existence of the cited
deficiency. Having concluded that Petitioner has failed to
maintain a sanitary, orderly, and comfortable interior for its
residents, it follows that such non-compliance with the regulatory
requirements could potentially compromise such residents' health
and safety or at least compromise their mental or psychosocial
well-being. Residents have a right to reside in a clean, safe and
healthy environment. Petitioner's conduct is in variance to this
right imposed by OBRA '87.
D. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 272 (HCFA Ex. 2 at 3-4):
42 C.F.R. 483.20(b)(1) (1) The facility must make a
comprehensive assessment of a resident's needs, which --
(i) Is based on a uniform data set specified by the Secretary
and uses an instrument that is specified by the State and approved
by the Secretary; and (ii) Describes the resident's capability to
perform daily life functions and significant impairments in
functional capacity.
(2) The comprehensive assessment must include at least the
following information:
*****
Based upon observation, interview and medical record review[,]
it was determined that comprehensive assessments contained
inaccuracies of residents functional ability.
Findings include;
Inaccuracies were noted on 3 [o]f 5 medical records reviewed
of residents capacity to perform daily life functions, i.e.;
toileting, incontinence, activities of daily living, transfer,
locomotion, personal hygiene, and psycho-social functioning. Many
of the activities of daily living were contradictive and did not
reflect the residents admission or current status.
For example, resident 12 was assessed to require supervision
with transfers, ambulate and toilet independently but required
assistance with personal hygiene. Furthermore, the psycho-social
assessment indicated there were no problems, however the resident
is [sic] in fact been seeing the psychologist weekly for several
months and receives Elavil 50 mg. on a daily basis for depression.
28/
Petitioner argues that the only resident who was identified as
being the subject of the surveyor's allegations was resident 12.
P. Br. at 36, 38. Petitioner contends that "[t]here was a complete
failure of proof concerning the allegations of inaccuracies (with
respect to resident 12) regarding transfers, ambulation, and
psychosocial assessment." Id. at 40. Petitioner contends that Ms.
Shekell's testimony was inconsistent and that resident 12's MDS
[minimum data set] "complied with the regulations." Id. at 44.
Petitioner states also, among other things, that the testimony of
Ms. Patience suggests that F 272 was incorrectly cited, and that
the proper citation should have been F 287. P. Br. at 47, 118. 29/
As a preliminary matter, I must first address the issue of which
residents were identified to Petitioner as being the basis of the
allegations. Although the HCFA 2567 mentions that "3 of 5 medical
records" were reviewed, I find that this did not adequately
identify the other residents in addition to resident 12 who were
the subject of Ms. Shekell's findings such that Petitioner could
have a meaningful opportunity to respond to the allegations. At
the hearing, when asked if she recalled identifying any specific
patient records to Petitioner during the survey or exit conference,
Ms. Shekell testified, ". . . we don't really discuss the specific
patients during the exit conference. However, during the survey
process we talk to the facility staff regarding individual patients
in which we find inconsistencies or problems." Tr. 154. Ms.
Shekell stated that she spoke to Petitioner's staff about resident
12, but she could not recall whether she spoke to them about the
other patient records she alluded to in her findings on the HCFA
2567. Tr. 155.
Thus, despite the fact that Ms. Shekell referred to other patient
records in HCFA 2567, the record of resident 12 is the only
resident record against which Petitioner could adequately prepare
a defense with respect to F 272. With respect to the other
residents referred to in HCFA 2567, HCFA was unable to specifically
identify them or the records alleged to be deficient. HCFA did not
prove that Petitioner's treatment of other residents, in addition
to resident 12, violated 42 C.F.R. 483.20(b)(1). Accordingly,
I am deciding whether HCFA has proven its claim that Petitioner was
in violation of section 483.20 (b)(1) (F 272) based only on my
consideration of the medical record of resident 12. 30/
Furthermore, Ms. Shekell testified on cross-examination that the
sentence "For example, resident 12 was assessed to require
supervision with transfers . . . personal hygiene" which she wrote
in the HCFA 2567 is not a deficiency, but merely "a statement of
fact." Tr. 323. Ms. Shekell stated that the actual deficiency she
is alleging is described in the following sentence: "Furthermore,
the psycho-social assessment indicated there were no problems, . .
. on a daily basis for depression." Tr. 324. 31/ Ms. Shekell
agreed with Petitioner's characterization that her basis for
finding fault with resident 12's record "is that one part of it
seems to say that the patient didn't have any psychosocial problems
when in fact [she] believe[d] other parts of the record indicate to
the contrary." Tr. 324.
HCFA argues that "[w]ith respect to resident 12, her mood and
behavior patterns (i.e. her mental and psychosocial status) and her
recurrent thoughts of death are not accurately described on the
underlying resident assessment instrument approved by the Secretary
(the MDS and its quarterly reviews)." HCFA Resp. Br. at 14. HCFA
claims that resident 12's MDS is "inconsistent, both internally and
with the documentation contained in other parts of the resident's
chart." HCFA Resp. Br. at 12. Simply stated, according to Ms.
Patience, ". . . the minimum data set didn't match what was going
on with the resident." Tr. 2681.
The MDS document is required to be completed for every resident
within the first 14 days after admission (42 C.F.R. 483.20
(b)(4)(i); Tr. 136), and addresses 18 areas, including delirium,
cognitive loss/dementia, ADL [activities of daily living]
functional/Rehabilitation potential, urinary incontinence and
indwelling catheter, psychosocial well-being, mood state, behavior
problems, falls, nutritional status, dehydration/fluid maintenance,
pressure ulcers, and physical restraints. 32/ The SOM 250 states:
"The information required in 483.20(b)(2)(i - xiii) is
incorporated into the MDS, which forms the core of each State's
approved RAI [Resident Assessment Instrument]." HCFA Ex. 13 at
P-100. A facility assesses a resident in each area by filling in
boxes on the MDS with either checks or numbers. 33/ A new MDS must
be initiated promptly after a resident experiences a significant
change in his physical or mental condition. In no case can the MDS
be done less than once every twelve months. 42 C.F.R.
483.20(b)(4)(iv)-(v); Tr. 138. 34/
Depending on a particular response on the MDS, an "automatic
trigger" or "potential trigger" may be indicated, and such triggers
direct the staff to fill out the corresponding category on another
document called the Resident Assessment Protocol Summary (RAPS).
35/ The RAPS lists the identical 18 areas found on the MDS (i.e.,
delirium, cognitive loss/dementia, visual function, communication,
ADL function/rehabilitation potential, etc.). The facility is
instructed to show, for each RAP area triggered, whether it is
proceeding with a care plan intervention by checking either
"proceed" or "not proceed" next to the problem area that
was
triggered. The facility is also to show where the appropriate
documentation (i.e., problems, complications, risk factors, reasons
for deciding to proceed or not to proceed to care planning) can be
found.
Resident 12's MDS was completed on July 30, 1993. P. Ex. 3 at 2.
The relevant section of the MDS for purposes of this deficiency is
Section H, which has the heading "Mood and Behavior Patterns". P.
Ex. 3 at 3-4. 36/ In subsection H.1 ("Sad or Anxious Mood"),
Petitioner's staff has checked off Boxes "a" and "e" to
indicate
that the resident had exhibited "verbal expressions of distress"
and "pervasive concern with health" during the last thirty days,
i.e., June 30 - July 30, 1993. 37/ P. Ex. 3 at 3. There were no
checks in Boxes "b"- "tearfulness, emotional groaning, sighing,
breathlessness"; "c"- "motor agitation such as pacing, handwringing
or picking"; "d"- "failure to eat or take medications, withdrawal
from self-care or leisure activities"; "f"- "recurrent thoughts
of
death and "g"- suicidal thoughts/actions". The absence of checks
reflected these behaviors were not exhibited in the covered period.
In subsection H.2 ("Mood Persistence"), Petitioner's staff filled
in a "0" (i.e., zero) next to the phrase "Sad or anxious mood
intrudes on daily life over last 7 days -- not easily altered,
doesn't "cheer up". P. Ex. 3 at 3. The zero represents that
resident 12 had not experienced any sad or anxious mood during the
time frame of July 24-30, 1993. Also, in subsection H.6,
Petitioner's staff indicated that the resident had not had a change
in mood in the 90 days preceding. Id.
As discussed earlier, certain responses on the MDS will set off
"triggers" which direct the staff to fill out the corresponding
section on the RAPS. Then, based on the information contained in
the MDS and the RAPS, Petitioner formulates an individualized care
plan which will be responsive to the resident's problems and needs.
see Tr. 2504.
Here, with respect to resident 12, the presence of "verbal
expressions of distress" and "pervasive concern with health",
as
indicated on the MDS, constitute
"automatic triggers". I find that Petitioner filled out the RAPS
for these two problem areas which were triggered (P. Ex. 3 at 6)
and that the RAPS, with accompanying notes, are consistent with the
July 1993 MDS. P. Ex. 3 at 6, 9.
Resident 12's record contains also a care plan entry dated
September 1, 1993. Petitioner's staff wrote, under "psychosocial
needs", the following: "Resident chooses not to leave her room
except for dialysis 3x/wk & group psychotherapy 1x/wk." P. Ex. 3
at 24. The "measurable and time oriented objectives" stated that
the "resident will receive socialization from staff, family or
other residents QD x 3 months by 12/1/93." Id. The
"approaches/actions" to be taken included encouraging family visits
and participation, and group and individual psychotherapy. Id.
These care plan entries appear to have been written in response to
a Social Assessment completed on September 1, 1993, on which a
social worker indicated that the resident was depressed due to
illness and separation from family, and was motivated to progress.
P. Ex. 3 at 21.
On September 13, 1993, a physician's order in resident 12's chart
states that the resident "may attend psychological meeting Q
Wednesday". Also, a physician's order dated September 14, 1993
states "psychology eval & tx as indicated by psychologist." P.
Ex.
3 at 10-11.
On September 15, 1993, the resident underwent a diagnostic
interview with a psychologist, and the psychological diagnostic
interview report states that the resident had been referred due to
"depressive Sx, difficult adjustment to losses, and isolation". P.
Ex. 3 at 15. In giving the mental status exam results and the
interview findings, the examining psychologist wrote that she
"appears to be experiencing major depression today, speaking of
being ready for death (suicide risk minimal)[.] No signs of
delusions/hallucinations. Cooperative and desirous of pleasing
examiner." Id. Although the form contains a depression scale,
this was left blank. Id.
Based on this 9/15/93 psychological report, I find that the
resident showed an indication of a potentially serious
psychological problem. However, Petitioner did not conduct a new
MDS at this time and left the July 1993 MDS in place, unchanged.
In doing so, Petitioner thus inaccurately represented that the July
1993 MDS continued to reflect the current condition of resident 12
although it did not. As of September 15, 1993, based on the
psychological report, the assessment of the resident's mood and
behavior patterns as stated in the July 1993 MDS was no longer
accurate due to the resident's change in her psychosocial status.
The fact that the resident was experiencing a level of depression
which had not been noted previously, as described by the
psychologist, constituted a significant change in her condition
within the meaning of SOM 250. 38/
Ms. Patience testified:
If the resident is exhibiting a change then there may be a new
minimum data set indicated, and that needs to be done if the
resident's got a significant change.
Tr. 2495.
When asked what type of mood change would necessitate a change in
the assessment, Ms. Patience responded:
If the resident's a little bit blue that might not indicate
that there needs to be a whole new MDS. If the resident is
depressed, definitely there needs to be a new MDS done. Because
the depression can impact things like eating, mobility, whether or
not the resident wants to interact with other residents; all of
those can be affected by depression.
Tr. 2496.
Ms. Patience stated also that resident 12's treatment by a
psychologist and the order for Elavil would constitute a
significant change in her condition. Tr. 2501; see Tr. 2497. She
expressed her opinion that, with respect to resident 12, she "would
have expected a new minimum data set sometime in September." Tr.
2501; see Tr. 2674.
Petitioner should have completed a new MDS after resident 12's
psychological interview to reflect the change in her psychosocial
status. The completion of a new MDS would have resulted in boxes
"g" and "d" under section H.1. being checked, indicating
that the
resident had "suicidal thoughts/actions," and exhibited "withdrawal
from self-care or leisure activities," respectively. P. Ex. 3 at
3. These boxes had not been checked off on the July 1993 MDS. In
addition, the presence of these symptoms are "automatic triggers",
which would then have directed Petitioner to fill out the RAPS for
these specific areas. This process did not occur.
The resident was provided weekly individual and/or group
psychotherapy by a psychologist starting September 15, 1993 through
December 22, 1993. 39/ P. Ex. 3 at 16 - 19. The weekly entries
suggest some improvement in her mental state over this period of
time. Id. A physician order dated 10/12/93 in the resident's
chart states "D/C Restoril; Elavil 50 mg. HS [hour of sleep]
(insomnia)." 40/ In her medication records, there is an entry
dated October 12, 1993 that states "Monitor episodes of depression
as evidenced by expressing wanting to die. Hs. (Elavil). P. Ex.
3 at 12. Despite her serious depression with suicidal ideation on
September 15, 1993, her medication was not changed or monitoring
initiated until October 12, 1993. 41/ Almost 30 days elapsed from
the time of the resident's 9/15/93 psychological interview before
Petitioner began to more aggressively treat her depression with
medication and increased monitoring. This delay in providing
additional treatment was potentially detrimental to resident 12
when one considers that her initial depression had deteriorated
from observable signs of isolation to suicidal thoughts, a clear
indication of a worsening in her depressive state.
With respect to care-planning, the record indicates that her
isolation was care-planned on September 1, 1993. P. Ex. 3 at 24.
Her suicidal ideation, as illustrated by her expressing a desire to
die on September 15, 1993, was not care-planned until November 17,
1993. Id. The approaches/actions which Petitioner's staff listed
in connection with the November 1993 entry included encouraging the
resident to socialize, encouraging activities of choice of
interest, and having cheerful dialogue with the resident while
giving care. Id. Thus, Petitioner delayed over two months before
implementing a care plan to address resident 12's suicidal
ideation. More importantly, Petitioner delayed approximately one
month before responding to her worsening depression with Elavil and
monitoring her for suicidal ideation. Such a delay could have had
serious detrimental consequences on her health and safety. The
protections afforded residents through the MDS assessment protocols
were obviated by Petitioner when it failed in September 1993 to
record her deteriorating mental condition which would have
triggered a formal assessment of her mental state and consideration
of whether a new plan of care was necessary to respond to the
change in her condition. Additionally, one of the mechanisms built
in to the assessment process to ensure a resident's proper care and
treatment is that a resident's care plan must be prepared by an
interdisciplinary team made up of the appropriate persons. With
respect to the care plan entries of September 1, 1993 and November
17, 1993, there is nothing in the record to indicate that these
entries were formulated in accordance with these protocols.
Ms. Shekell testified:
You would expect to see that somebody that has a mood
disturbance over a period of time that it would be reflected in the
assessments. According to their assessments that has not been
identified as a problem, and the regulation does state that the
record must show
an accurate and concise assessment of the patient at any time.
*****
The goal is that the staff must make a complete assessment of
the patient to actually reflect what the patient's needs are, and
from that they develop a patient care plan for which they care for
the patient based on that assessment of identified needs, and then
they can set goals to help the patient with the identified
problems.
Tr. 148, 150-151.
Resident 12 manifested serious problems in terms of her
psychosocial well-being and her July 30, 1993 MDS was inaccurate
with respect to her psychosocial status as of at least September
15, 1993, or possibly as early as September 1, 1993, which is the
first indication in the record that she wanted to isolate herself
42/. Moreover, there is no evidence in the record that Petitioner
ever completed a new MDS for resident 12. While the resident did
appear to benefit from weekly group and individual psychotherapy
sessions and become less depressed, as indicated by the progress
notes for September 1993 through December 1993 (P. Ex. 3 at 16-19),
her depressive symptoms were never totally eliminated.
Based on the above, Petitioner violated the requirement found at 42
C.F.R. 483.20(b)(1), with respect to this resident. Section
483.20 mandates that the resident assessment conducted by the
facility be an accurate comprehensive assessment of the resident's
functional capacity. Sections 483.20(b)(1)(i) and (ii) mandate
that 1) such assessment be "based on a uniform data set specified
by the Secretary and uses an instrument that is specified by the
State and approved by the Secretary" and 2) such assessment
"describe the resident's capability to perform daily life functions
and significant impairments in functional capacity." In short, the
MDS should accurately reflect the resident's functional
capabilities. This instrument is used to prepare a comprehensive
care plan for any medical condition assessed by the facility as
impacting on the resident's ability to function -- the goal being
to assist the resident in attaining and maintaining his or her
highest practicable physical, mental, and psychosocial well-being.
42 C.F.R. 483.20(d). Here, Petitioner's failure to maintain an
accurate assessment of this resident's condition as the level of
her depression worsened prevented the formulation of a timely
comprehensive care plan prepared using the protocols specified by
HCFA and which corresponded to her change in psychosocial
well-being.
While the July 1993 MDS may have been accurate at the time it was
completed, it no longer reflected the true condition of resident
12's psychosocial status as of September 1993. Petitioner failed
to conduct a new MDS in September 1993, and by leaving an
inaccurate MDS in place, it did not comply with 42 C.F.R.
483.20(b).
By failing to accurately document resident 12's depression in the
assessment instrument, Petitioner acted contrary to the directives
of OBRA '87 and contravened its obligation to provide appropriate
"individualized care" of high quality to its residents. Congress
intended that the resident assessment instrument accurately
describe a resident's functional capacity and health status. See
section IV. of this decision. In imposing this obligation on a
facility, Congress recognized that a comprehensive resident
assessment was crucial to providing high quality care to a
resident. Id.
As part of its response to this deficiency, Petitioner argued that
F 272 was cited in error:
Ms. Patience finally testified that the indicated deficiencies
concerning the failure to update assessments to conform to the
condition of the patient (asserted inaccuracies) are not in fact
the subject of F272 but are actually addressed in F287, which is
the only F tag that covers her criticisms.
P. Br. at 47, citing Tr. 2658-2659.
At the hearing, Ms. Patience did acknowledge that, if a deficiency
was based on failure to complete an MDS after a significant change
in a resident's condition, the appropriate citation would be F 287.
Tr. 2658-2659, 2683. In addition, Ms. Patience stated that a
failure to change the MDS "could trigger other Ftags." Tr. 2683.
Ms. Patience did express her opinion that the alleged findings
concerning resident 12 would lead to a deficiency under F 287. Id.
However, contrary to what Petitioner contends, Ms. Patience did not
testify that F 287 was the only applicable citation for the alleged
deficiency. In response to my questioning, Ms. Patience stated
that the alleged findings relating to resident 12
could also trigger 272. We sometimes use 272 to illustrate a
pattern of deficient practice in relation to the minimum data set
in the assessment process. And, so it wouldn't be entirely
improper that it was under 272.
Tr. 2683-2684.
According to SOM 250, the regulation which is the basis of F 287 is
42 C.F.R. 483.20(b)(4)(iv), which states that a facility must
conduct assessments "promptly after a significant change in the
resident's physical or mental condition". HCFA Ex. 13 at P-103.
As I have discussed, when resident 12 exhibited symptoms of major
depression and spoke of being ready to die in September 1993, these
circumstances constituted a significant change in her psychosocial
condition which warranted the completion of a new MDS. 43/
Additionally, with respect to Petitioner's contention that "there
was no "pattern" of inaccurate MDS record-keeping in the facility"
(P. Resp. Br. at 14), I find this argument to be inapposite. To
meet its burden of proof with respect to this alleged deficiency,
HCFA did not have to prove that a pattern of inaccurate MDS
documentation existed with other residents. As stated in SOM 250,
a situation that affects a single resident may be cited as a
deficiency. There is no specific standard that must be met. The
threshold of what constitutes a deficiency varies from situation to
situation. HCFA Ex. 13 at P-29. The SOM 250 guideline does state
that a single occurrence directly related to a "life-threatening or
fatal outcome or high potential for such outcome may be cited as a
deficiency." Id. However, I do not construe this guideline as
precluding a finding of a deficiency where such an outcome cannot
be demonstrated. This guideline is written in the permissive sense
and does not mandate that such an extreme negative outcome must be
shown to conclude a deficiency exists where there is only one
occurrence. Here, I conclude that Petitioner's failure to comply
with the cited regulatory requirement negatively impacted on the
resident's treatment. Such a finding is sufficient to support the
existence of a deficiency.
E. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 289 (HCFA Ex. 2 at 4-5):
42 C.F.R. 483.20(b)(5) (5) Review of assessments. The nursing
facility must examine each resident no less than once every 3
months, (quarterly) and as appropriate, revise the resident's
assessment to assure the continued accuracy of the assessment.
*****
Based on record review and interview the facility failed to
review each resident's assessment for continued accuracy.
Findings include:
Resident 16 was incontinent of bladder on admission 5/1/93.
She was but [sic] on a bladder training program. A licensed
nurse's note at that time indicated that the resident would tell
when she had to go. The licensed nurse's assessment 11/11/93,
indicates she is incontinent of bladder, as does the current plan
of care. Licensed nurse's notes 12/3/93 state that she is
continent, however the next weekly summary states she is
incontinent. The nurse aide flow sheets from 12/1-12/15/93 reflect
that she is continent. Licensed staff interviewed were not sure
which of these documents were accurate. The resident has not been
accurately assessed and the care plan updated to reflect the actual
status of the resident. On 11/7/93 an entry in the plan of care
indicates that she tries to climb out of bed. A nursing approach
to toilet the resident when her restraints are released, is
included. There was no routine individual schedule developed to
meet the resident's needs.
Cross reference F290.
Residents medical records reviewed indicated inaccuracies of
the resident mental, physical, and psychosocial status on an
ongoing basis. Records indicated no mood, behavioral and
psychological problems when they were in fact receiving
psychotropics, antianxiolytic, sedative and/or hypnotic drugs. The
assessments were not congruent with the physicians progress notes
or nurses notes. The assessments were not consistent with current
treatment needs or the current patient care plans.
The quarterly assessments did not reflect the residents status
on the 18 elements of the resident assessment protocol summary
(RAPS).
The first part of this alleged deficiency concerns resident 16 and
the issue of whether Petitioner accurately assessed resident 16's
state of bladder continence. HCFA argues that "neither the MDS nor
the quarterly evaluations reflected [the] significant change in
resident 16's state of bladder continence" and contends that there
was "apparent confusion and lack of documentation in the medical
record as to her actual state of continence at any given time".
HCFA Br. at 30, 33.
Petitioner argues, among other things, that the resident's
assessment "was accurate and did not require change more than once
every three months"; confusion on the part of Petitioner's staff
did not "violate the regulation or require a change in the
resident's assessment because her condition was in a continual
state of change"; and "[t]here are no standards other than nursing
judgment which determine when a change in a patient's state of
continence requires a change in the assessment other than a drastic
change." P. Br. at 48.
Resident 16 was admitted to the facility on May 1, 1993. P. Ex. 4
at 1. At the time of admission, a bowel and bladder assessment was
done, which reflected that the resident was "inc[ontinent] of
b[owel] and b[ladder] and "not a candidate for bladder and bowel
retraining [secondary to] unawareness of bodily function." P. Ex.
4 at 11. On resident 16's MDS, which was completed on May 14,
1993, Petitioner's staff assessed her as being incontinent of bowel
and bladder. P. Ex. 4 at 3. 44/
The medical documentation for resident 16 includes also quarterly
reviews for the quarters ending August 12, 1993 (90-day assessment)
and November 5, 1993 (180-day assessment). 45/ P. Ex. 4 at 7-8.
On these assessments, Petitioner's staff has indicated in the
relevant section (Section F) that resident 16 was incontinent of
both bowel and bladder for the last 14 days of these two quarterly
periods. P. Ex. 4 at 7-8. The specific time frames, then, for
which Petitioner was assessed as incontinent of bladder for
purposes of these quarterly reviews were 7/29/93 - 8/11/93, and
10/22/93 - 11/5/93.
With respect to the August 1993 quarterly assessment, I find that
it does not appear to be one of the assessments underlying HCFA's
allegations in the HCFA 2567. With the exception of the reference
to resident 16's 5/1/93 admission, the findings alleged in the HCFA
2567 in support of this deficiency relate to the months of November
and December 1993. Accordingly, I will not address the August 1993
quarterly assessment, as it falls outside of the relevant time
frame focused upon by HCFA in this alleged deficiency.
With respect to the November 1993 quarterly assessment, which is
relevant, the issue of whether or not Petitioner's staff accurately
assessed resident 16 as being incontinent during the time frame of
10/22/93 - 11/5/93 (i.e., the last 14 days prior to the quarterly
assessment) necessitates a review of the documentation pertinent to
this time period. The October 1993 flow sheets show that for the
"Day Shift" during the period October 22-31, Petitioner's staff had
written the notation "x3" or "3" in the boxes on the "incontinent"
(bladder) line. P. Ex. 4 at 15. 46/ During the "P.M. Shift" for
this same time frame, Petitioner's staff had written in "O" in the
boxes on the "incontinent" (bladder) line. Id. at 16. 47/ For the
"night shift", a "1" was written in for 10/22, and 10/24
- 10/26,
a "0" was written in for 10/23, and for 10/28 - 10/31, and a "4"
was written in for 10/27. Id. at 17. 48/ Based on the October
flow sheet notations, it appears that, during October 22 - 31,
1993, resident 16 was incontinent three times daily during the "day
shift," was not incontinent at all during the "P.M. Shift", and
was
not incontinent for five of the ten days during the "night shift."
The 11/1 - 11/15/93 flow sheets indicate that, during the "night
shift", resident 16 was found to be incontinent of bladder on
November 1 and 2, but was continent the rest of the time. P. Ex.
4 at 18. 49/ See Tr. 1435. For the "Day Shift" during this same
time period, several types of notations were written in by
Petitioner's staff: "C", "C/I", "I/3", "x3",
"C/2", "C/3", "3". 50/
During the "P.M. shift", there is a "C" written in for each
date,
indicating that resident 16 was found to be continent during this
entire time period. P. Ex. 4 at 18.
In light of the flow sheet evidence that resident 16 was exhibiting
continent behavior a significant amount of time during the end of
October and beginning of November 1993, I find that the 11/5/93
quarterly assessment indicating that she was incontinent is
inaccurate. While Petitioner did conduct a quarterly review, it
failed to reflect accurately resident 16's bladder continence
status, in violation of 42 C.F.R. 483.20(b)(5). 51/
According to the flow sheets for 11/16/93 - 11/30/93, resident 16
was continent during the "night shift" throughout this entire time
period. P. Ex. 4 at 19. However, with respect to the "day shift"
and "P.M. shift" for this time period, there are notations written
in the form of "C/(number)" and ""C x (number)", which
are unclear,
do not correspond to the legend, and are nowhere explained. The
fact that there are "I's" and "C's" written over each other
in some
of the boxes make the entries even more cryptic. 52/ Thus, the
only conclusion I can make is that resident 16 was continent at
least during the night shift of the second half of November. P.
Ex. 4 at 18-19.
From November 30, 1993 - December 2, 1993, resident 16 underwent a
"3-day evaluation for baseline data -- bladder training". P. Ex.
4 at 12. 53/ The chart indicates that, on each of these days, she
was found to be "dry" whenever checked by Petitioner's staff.
According to this chart, resident 16 was never found to be "wet" on
each of the three days. Id. An entry in the progress notes dated
November 30, 1993 reads "On B & B training. continent X 1 -- able
to ask CNA that she wants to go to bathroom. will continue to
monitor." P. Ex. 4 at 33-34.
In her testimony regarding the "3-day evaluation for baseline data
-- bladder training" chart, Ms. Cox stated that she did not see any
indication on the chart that the resident was incontinent, and
"that would indicate that the times that you checked her she was
either dry or she was capable of voiding. Whether they took her to
the toilet or bedpan, I don't know, it doesn't always indicate.
But it indicates that she would have some control." Tr. 1432-1433.
In the licensed nurses' progress notes, an entry dated December 3,
1993 at the bottom of the page reads "3 day eval. for baseline
data-bladder training completed & pt. is continent; she'll tell
when to go to the bathroom." P. Ex. 4 at 13. (duplicated at P. Ex.
4 at 34). 54/ Thus, the result of the three-day evaluation is that
resident 16 was assessed to be continent.
Such a change in resident 16's condition constituted a "significant
change" that should have resulted in Petitioner completing a new
MDS some time following the three-day evaluation. 42 C.F.R.
483.20(b)(4)(iv). Petitioner failed to do this and simply left in
place the MDS completed on May 14, 1993, which assessed resident 16
as being incontinent of bladder (and bowel). By not updating the
MDS, Petitioner plainly violated 42 C.F.R. 483.20(b)(5), which
required Petitioner, as appropriate, to revise resident 16's
assessment to assure its continued accuracy.
Petitioner's witness, Ms. Downing, testified herself that a
resident's quarterly assessment is changed more often than
quarterly "[i]f there is a drastic or significant change in the
condition." Tr. 1796; see Tr. 1798. She stated also that "You do
a new MDS, complete new MDS if there's a change in condition." Tr.
1796. 55/ Although Ms. Downing was of the opinion that "[T]here
was nothing here [sic] a drastic or significant change that
warranted a new MDS" (Tr. 1796), I disagree. Resident 16 did
experience a significant change in her bladder condition. Although
she was assessed as being incontinent of bladder on the MDS in May
1993, other medical documentation in her record established that
her condition improved significantly such that she was no longer
totally incontinent.
I note that the record contains also a weekly summary progress note
dated 12/10/93 and flow sheets for the period 12/1/93 - 12/31/93.
P. Ex. 4 at 14, 20-21. The 12/10/93 progress note states, in part,
"Incont. of B & B". P. Ex. 4 at 14 (duplicated at p. 35). 56/
With respect to the December 1993 flow sheets, they contain also
notations other than a simple "C" or "I", and which resemble
notations previously discussed. P. Ex. 4 at 20-21. For the first
half of December 1993 (12/1-12/15), in the "Night shift" section,
there are some "C's" written in the chart to describe the
resident's bladder condition, as well as "C/2", "C/3", "I/3",
"I/4", and "I/0" in some of the boxes. P. Ex. 4 at 20. In
the
"Day Shift" section, Petitioner's staff has written in the
notations "Cx3", "C/3", "C/2", and "C/4".
Id. The notations
"C/1", "C/2", and "C/3" appear in the bladder
section under the
"P.M. Shift". Id. When asked about these notations (for the
period 12/1-12/15/93), Ms. Cox stated, "Well, I see the same type
charting, some of which I don't understand, I have to admit. And
I can only say that it is not clear to me what this means." Tr.
1441. 57/ Notations of similar form appear in the nurse assistant
record for the period of 12/16-12/31/93. P. Ex. 4 at 21. 58/
When asked about the "night shift" bladder notations for the first
half of December 1993 (12/1-12/15/93), Ms. Downing interpreted them
in the following manner 59/:
It has incontinent on the 10th times three. Incontinent on
the 11th times four. Incontinent on the 13th times, it says zero.
So, I would assume that means she was dry that day.
Q [Petitioner's counsel]: "That's just the -- that's just the
night shift?" A [Ms. Downing]: "Right. That's the number of
times she was checked." Tr. 1777.
With respect to the "day shift" bladder notations for this same
time frame (12/1-12/15/93) (P. Ex. 4 at 20), Ms. Downing stated "I
would say it looks like she was incontinent [sic] -- continent or
dry on the day shift." Tr. 1777. When asked about the resident's
bladder condition during the "p.m. shift", Ms. Downing testified,
"It looks like, yes she was continent on those days." Id. Based
on her review and interpretation of these notations for all three
shifts, Ms. Downing expressed her opinion that the statement in the
HCFA 2567 that the 12/1-12/15 flow sheets reflect the resident to
be continent was "inaccurate". Ms. Downing stated, "No, she was
not totally continent". Tr. 1778.
HCFA's witness, Ms. Patience, also was questioned about the
December 1993 flow sheets. With regard to the 12/1-12/15 flow
sheet (P. Ex. 4 at 20), Ms. Patience stated the information in the
chart indicated "[t]hat the resident was continent from December
1st through December 15th -- continent of bladder." Tr. 2508. Ms.
Patience testified further that the information on the 12/16-12/31
flow sheet indicated "[t]hat the resident from December 16th
through December 31st was also continent of bladder." Tr. 2508.
The testimony of Ms. Downing and Ms. Patience concerning the 12/93
flow sheet notations calls into question the validity of the
12/10/93 weekly summary progress note. Also, given that resident
16 was assessed as "continent" following the three-day evaluation,
which was completed on 12/2/93, the weekly progress note appears to
be inaccurate. In light of the testimony of both Ms. Downing and
Ms. Patience, it appears that, while resident 16 may not have been
"totally continent" during the first half of December, she could
possibly be described as being mostly continent for the month of
December. In any event, I conclude that resident 16 was not
incontinent during December 1993.
By ignoring its obligation to comply with 42 C.F.R.
483.20(b)(5), Petitioner was essentially representing that between
May 1993 and the time of the survey (December 1993), resident 16
had not undergone any changes at all with respect to her continence
status and remained totally incontinent. Such misleading and
inaccurate information about resident 16's health status was
precisely what OBRA '87 was intended to prevent with its
patient-oriented reforms. 42 C.F.R. 483.20(b)(5) mandates that
a facility must conduct quarterly assessments and "as appropriate,
revise the resident's assessment to assure the continued accuracy
of the assessment." Petitioner should have had updated and
accurate assessments in resident 16's medical record which
documented that her condition changed significantly from being
incontinent of bladder to either continent or mostly continent. In
sum, Petitioner's November 1993 quarterly assessment of resident 16
was inaccurate and, based on the evidence of continence following
the 3-day bladder evaluation, there was evidence based on that data
alone to conclude a significant change in resident 16's status had
occurred to warrant a modification of her assessment instruments.
Failure to have an accurate assessment of her continence prevented
this resident from attaining her highest practicable level of
physical, mental, and psychosocial well-being and potentially could
have compromised her health and safety, since she could have been
exposed to infection if continence had not been maintained.
Ms. Cox alleged further in the HCFA 2567 that resident 16's care
plan was not updated to reflect her actual status. HCFA Ex. 2 at
5. This allegation pertaining to resident 16's care plan is
extraneous to the regulation and, therefore, I do not consider it.
60/
Petitioner argues that Ms. Patience acknowledged that there are no
specific documentation standards governing what length of time of
continence or incontinence is needed to be demonstrated in order to
necessitate changing a resident's assessment. P. Br. at 55.
Petitioner avers that, outside of a drastic change in a resident's
condition, nursing judgment should control as to when a resident's
assessment should be revised due to a change in continence status.
Id. Petitioner's argument is without merit. I find that Ms. Cox
did, in effect, defer to nursing judgment in reviewing resident
16's medical chart. Ms. Cox based her findings on notations and
entries written by Petitioner's staff and found that Petitioner's
staff made a determination at one point in time that the resident
had become continent. Based on this assessment of the resident by
Petitioner's staff, Ms. Cox then concluded that Petitioner should
have completed a new assessment of the resident which accurately
stated her improved bladder condition. Contrary to what Petitioner
argues, it appears that Ms. Cox gave great weight to the nursing
judgments contained in the various medical documents.
Ms. Cox testified also that "[t]he nurse aide flow sheets and the
weekly nurses' summaries were in conflict with each other compared
to their bladder assessment that was finished 12-3. . . . None
ever [sic] that information agreed." Tr. 1240-1241. Ms. Cox
testified further that Petitioner's staff "were not sure which
documents were accurate." Tr. 1241. In response to these claims,
Petitioner argued that the "confusion of the licensed staff is not
a violation of the cited regulation." P. Br. at 55. While section
483.20(b)(5) does not address internal consistency of documentation
per se, it is evident that the objective of this regulation is to
describe a resident's condition and health status as accurately as
possible. The fact that the documents in resident 16's medical
chart appear to demonstrate some internal inconsistency underscores
further the inaccuracy of the recordkeeping with respect to her
bladder condition.
The next part of the deficiency, as set forth in the HCFA 2567,
alleged:
On 11/7/93 an entry in the plan of care indicates that she tries to
climb out of bed. A nursing approach to toilet the resident when
her restraints are released, is included. There was no routine
individual schedule developed to meet the resident's needs.
HCFA Ex. 2 at 5.
This allegation is extraneous to the regulation and, therefore, I
do not consider it.
With respect to the group of allegations in the HCFA 2567
concerning "Residents medical records reviewed indicated
inaccuracies of the resident mental, physical, and psychosocial
status on an ongoing basis . . . ", Ms. Shekell stated that she
"contribute[d] to writing [this] deficiency." Tr. at 162.
Apparently, another surveyor, Ms. Chute, who has since passed away,
also had reviewed some of the records which are the basis for these
findings. Tr. at 181, 193.
Ms. Shekell testified that resident 12, who had been the subject of
another alleged deficiency (F 272), was one of the subjects of this
group of allegations. Ms. Shekell stated that resident 12's
quarterly reviews failed to indicate that she had mood problems and
were thus inaccurate. Tr. 176-178; P. Ex. 10 at 16. Resident 12's
chart contains quarterly reviews dated October 27, 1993, January
28, 1994, and April 22, 1994. P. Ex. 3 at 7. I do not discuss the
latter two quarterly reviews since they are outside of the relevant
time frame for purposes of this decision.
With respect to resident 12's 10/27/93 quarterly review, I find
that HCFA did not prove that it is inaccurate. On the 10/27/93
quarterly review, Petitioner's staff had written in a zero in
section H.2 next to the phrase "Sad or anxious mood intrudes on
daily life over last 7 days - not easily altered, doesn't 'cheer
up.'" The zero represents that resident 12 had not displayed this
mood pattern during the relevant time frame, i.e., October 20 - 27
1993. The progress notes for October 1993 show that the resident's
progress toward stabilizing her depressed mood was at about the
same level as in September. P. Ex. 3 at 17. An entry dated
October 6 states: "spirits up -- probably due to word (incl.
pictures) from family in Philippines. Another entry dated October
27 states that the resident "has established ties c grp members &
is speaking more to them in & outside of grp. She also is able to
converse more openly, a big step." Id. Based on these entries,
the 10/27/93 quarterly review is not inaccurate.
However, in examining the documentation outside of the October 1993
quarterly review time frame, I previously concluded in section X.D.
of this decision that resident 12's July 30, 1993 MDS was
inaccurate with respect to her psychosocial status as of at least
September 15, 1993, or earlier, possibly September 1, 1993, which
is the first indication in the record that she wanted to isolate
herself (P. Ex. 3 at 22). There is no evidence in the record that
Petitioner ever completed a new MDS for resident 12. Because
Petitioner failed to "assure the continued accuracy" of resident
12's assessment instrument", I conclude that it violated 42 C.F.R.
483.20(b)(5) with respect to resident 12.
Additionally, Ms. Shekell testified that P. Ex. 9 (resident G.B.)
was one of the resident records that was "part of the survey team's
basis" for this alleged deficiency. Tr. at 195. Ms. Shekell
stated that she did not herself view the resident whose record is
P. Ex. 9; she believed that this resident's record had been
identified and reviewed by Ms. Chute. Tr. at 191-193.
In discussing resident G.B., Ms. Shekell stated that there was an
inconsistency between his MDS, which indicated that the resident
did not have any mood problems, and his care plan, which indicated
that he was taking antidepressant medication and had an episode of
crying on February 24, 1993. Tr. 195-198. See P. Ex. 9 at 2, 5.
Ms. Shekell testified also that a Social Services note dated
November 30, 1993 stated that the resident was "taking an
antidepressant to reduce episodes of crying related to neurogenic
pain. Social Services will provide emotional support to resident
during one on one visits." Tr. at 199-200; P. Ex. 9 at 19. Ms.
Shekell stated further that another entry dated December 13, 1993,
written by a licensed social worker mentioned, among other things,
that "referral to psychologist is appropriate [to] address his
refusal of treatment." Tr. at 201. See P. Ex. 9 at 20. Ms.
Shekell noted that, according to the Physician Orders, the resident
had been on Prozac, which was discontinued sometime around May 24,
1993, at which time the resident was started on 25 mg. of
Desipramine, which was increased to 50 mg. after four days. Ms.
Shekell stated that a Physician Order dated November 16, 1993
indicated that the resident was receiving 150 mg of Desipramine
daily (at bedtime) for depression. Tr. at 201-202; P. Ex. 9 at 21,
23. Ms. Shekell expressed her opinion that this "would indicate to
[her] that the patient had an escalating problem for the doctor to
increase his orders to that extent." Tr. at 202.
In addition, HCFA argued that resident G.B.'s quarterly reviews
dated May 28, 1993, August 23, 1993, and December 1, 1993, did not
indicate that he had any mood or behavior problems. P. Ex. 9 at
6-7; HCFA Br. at 36. 61/
Based on Ms. Shekell's testimony and the record before me, the
August 23, 1993 quarterly review, which indicated that resident
G.B. had no mood problems in the last seven days, is accurate. A
social services note dated 8/23/93 stated, among other things, that
"Episodes of crying are being monitored by nursing staff [with] a
total of 6 from May - July." P. Ex. 9 at 16. Based on this
information, G.B. apparently had not experienced any mood problems
in the month of August.
However, I find that Petitioner inaccurately assessed resident
G.B.'s mood problems in the quarterly reviews dated May 28, 1993
and December 1, 1993. According to these assessments, G.B. did not
display any "sad or anxious mood" over the last seven days of these
two quarterly periods (section H.2.). P. Ex. 9 at 6. However, it
cannot be disputed that G.B. was experiencing depression, for which
he took Prozac, and that, in late May, he was discontinued from
Prozac and put on Desipramine. Moreover, the 11/30/93 Social
Services note which mentions that G.B. is "taking an antidepressant
to reduce episodes of crying related to neurogenic pain. SS will
provide emotional support to resident during 1:1 visits" (P. Ex. 9
at 19) is further evidence that G.B. was experiencing mood
problems. These quarterly assessments are thus inaccurate, and
Petitioner's failure to maintain an accurate assessment of G.B.'s
psychosocial status represented a breakdown in the assessment
process which could have a potentially negative impact on G.B.'s
psychosocial well-being and the treatment of his depression. I
thus find that, with respect to resident G.B., Petitioner violated
42 C.F.R. 483.20(b)(5).
Resident G.B.'s chart does contain a 2/24/93 care plan entry noting
"Episode of crying", and a corresponding objective for G.B. to
"have less than 3 episodes x 1 month; x 3 months", which is further
dated May 24, 1993, August 24, 1993, and November 24, 1993. P. Ex.
9 at 2. While it appears based on this information that Petitioner
was taking into account resident G.B.'s mood problem through his
care-planning, I do not conclude that these care plan entries were
formulated in conjunction with the proper assessment protocols.
Because Petitioner did not have in place accurate assessments, upon
which a care plan is based, it is questionable whether the
protocols mandated by the regulations were in place and used with
respect to resident 12.
Petitioner also should have completed a new MDS for resident G.B.
some time following the 12/13/93 multi-disciplinary report entry
which noted that he was refusing treatment. P. Ex. 9 at 20.
Because there is no date for resident G.B.'s MDS which is in the
record before me, I assume that it was completed upon G.B.'s
admission on February 17, 1993 (P. Ex. 9 at 13), or within 14 days
of his admission. 62/ According to this MDS, G.B. was not
resisting care. P. Ex. 9 at 5.
However, when resident G.B. began to refuse treatment in December
1993, this represented a significant change in behavior.
Petitioner should have completed a new MDS for G.B., but failed to
do so. As I have discussed earlier, the MDS must accurately
reflect the resident's functional capabilities. By failing to
"assure the continued accuracy" of resident G.B.'s assessment
instrument, Petitioner further violated 42 C.F.R. 483.20(b)(5)
with respect to this resident.
As for the last part of the allegations in the HCFA 2567 with
respect to F 289 ("The quarterly assessments did not reflect the
residents status on the 18 elements of the resident assessment
protocol summary (RAPS)."), HCFA stipulated at the hearing that it
was no longer asserting this part as a basis for a violation under
F 289. Tr. 1832-1834.
F. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 290 (HCFA Ex. 2 at 6):
42 C.F.R. 483.20(b)(6) (6) Use. The results of the assessment
are used to develop, review, and revise the resident's
comprehensive plan of care, under paragraph (d) of this section.
*****
Based on record review and interview the facility failed to
review and revise each resident's plan of care.
Findings include:
Resident 16 was assessed as being incontinent of bladder at
the time of admission. When the resident's condition improved and
she was continent the plan of care was not changed.
Cross reference F 289.
With respect to this alleged violation, HCFA notes that it involves
one of the residents who had been the subject of F 289. HFCA
asserts that, while the deficiency under F 289 was premised on
Petitioner's failure to "review and revise the assessment for
resident 16", this deficiency under F 290 "concerned the facility's
failure to use the results of the most current assessment of the
resident's condition with respect to bladder continence to revise
her Comprehensive Care Plan." HCFA Br. at 37.
Petitioner contends that "[a] finding of a deficiency under F290 is
dependent upon the existence of an [sic] deficiency under F289 . .
.". P. Br. at 58. Petitioner contends further that "[t]here is a
significant evidentiary problem because the patient's plan of care
was apparently not put in evidence by HCFA at the hearing. . .".
Id. at 59. Petitioner alleges that the relevant plan of care was
not made part of the record before me and, thus, HCFA has failed to
prove this deficiency. Id.
I note that, in testifying that resident 16's care plan was not
updated to account for her change in bladder condition (Tr. 1442),
Ms. Cox stated that she didn't have the care plan before her. Tr.
1238, 1239, 1247, 1442. While the possibility exists that there
may be other care plans for resident 16 which were not included
among the medical documentation comprising P. Ex. 4, my analysis of
whether or not Petitioner was deficient in resident 16's
care-planning rests solely on what I admitted into evidence, my
previous analysis of F 289 and Petitioner's failure to rebut Ms.
Cox's observations cited in the deficiency by offering into
evidence a care plan in variance with her observations.
The two relevant care plan entries dated May 1, 1993 and November
7, 1993 which are included in P. Ex. 4, at pp. 22-23, note resident
16's incontinency, but make scant reference to her condition. In
the November 7, 1993 care plan, in the "Patient Problems/Needs"
column, there is an entry that says "At risk for impaired skin
integrity related to: incontinence, immobility." P. Ex. 4 at 22.
In the "Approaches/Actions" column of this care plan, there is an
entry that says "Cleanse & dry skin PRN after incontinence." Id.
The care plan dated May 1, 1993 contains an approach/action to
"Toilet and/or check for incontinency when restraints are
released." P. Ex. 4 at 23.
As I concluded in my analysis of F 289, resident 16 was mostly
continent for the first half of November 1993 and also was
continent at least during the night shift of the second half of
November. P. Ex. 4 at 18-19. Furthermore, upon completion of her
three-day evaluation for bladder training on 12/3/93, Petitioner's
staff assessed resident 16 to be continent and that "she'll tell
when to go to the bathroom." Id. at 13 (duplicated at P. Ex. 4 at
34). However, nowhere in the above- mentioned care plans does
Petitioner's staff mention resident 16's improvement in bladder
condition from incontinency to continence. 63/ Thus, they were
inaccurate. The obvious purpose of the care plan is to implement
procedures which are correlated to the findings from the
comprehensive assessment of the resident. Here, the resident was
demonstrating an ability to control her bladder. This is a very
favorable event, since it would likely enhance her well-being and
reduce the opportunity for infection. Under OBRA, Petitioner is
responsible for providing this resident with services necessary to
attain or maintain her highest practicable physical, mental, and
psychosocial well-being as required under 42 C.F.R. 483.25.
Thus, Petitioner was required to follow up on these indications of
an ability to be continent and institute procedures which would
reinforce such beneficial behavior by the resident in order to
ensure that her continence is maintained. The care plan is the
vehicle in which those procedures are documented for Petitioner's
staff who treat this resident. This was not done and is violative
of the regulations.
Petitioner thus violated 42 C.F.R. 483.20(b)(6) by failing to
revise resident 16's care plan once she was assessed by
Petitioner's staff to be continent. Such failure had the
potential to cause a negative outcome for this resident.
G. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 292 (HCFA Ex. 2 at 6-7):
42 C.F.R. 483.20(c)(1) (i) Each assessment must be conducted
or coordinated with the appropriate participation of health
professionals.
*****
Based on observation and medical record review it was
determined that the comprehensive assessment was inaccurate and did
not include the participation of all health professionals.
Findings include:
Resident 13's comprehensiv [sic] assessment was dated
12/10/93. Section E-4 for body control problems indicates only a
balance problem. Observation of the resident and review of the
medical record revealed that the resident has multiple join [sic]
contractures, progressive weakness, loss of mobility and a decrease
in independent transfers. The comprehensive assessment is
inaccurate and does not correspond to the plan of care.
During the survey, the surveyor noted that, with regard to resident
13, his comprehensive assessment was inaccurate and did not
correspond to the plan of care. HCFA Br. at 38. Resident 13's
comprehensive assessment, dated December 10, 1993, indicates only
a balance problem under Section E4 (Body Control Problems),
although observation of the resident and review of his record
revealed other physical problems. P. Ex. 20 at 4; HCFA Ex. 2 at 7.
This section was completed by a licensed vocational nurse (LVN).
Id. at 3.
When asked what contractures are, Ms. Patience stated:
[t]hey're portions of the body that are bent permanent -- bent
at an angle and require, if they're -- if the joint is going to
straighten, then it requires some sort of therapy, either with a --
restorative aid or with a physical therapist.
Tr. at 2537.
Ms. Patience noted also that the resident's care plan states that
resident 13 had multiple joint contractures as of December 10,
1993. P. Ex. 20 at 8. However, the minimum data set, also dated
December 10, 1993, in the section designating contracture to arms,
legs, shoulders, or hands, is blank. Id. at 4; Tr. at 2538.
Ms. Patience expressed her belief that it is important to a
resident's health and safety that contractures be noted on the MDS.
Tr. 2539. It was her opinion that, on admission, if a resident has
contractures, the failure to note them is not the type of omission
on the MDS that can be corrected within the 14 days allowed for
correction of "errors" on the MDS. Id. Ms. Patience testified
that
[c]ontractures aren't things that are easily missed. And, if
they didn't for whatever reason pick it up when the resident first
came in, then I would think that you would need to do a whole new
minimum data set because it does have impact on whether or not the
resident's going to be able to ambulate, feed themselves . . .
that's a pretty important component and if that was missed, then
they may have missed other things as well.
Tr. 2539-2540.
Ms. Patience stated further that "[w]e would expect, as far as the
contracture go, for it to designate exactly where, what the degrees
were of the contracture, in other words, how severe the contracture
was." Tr. 2540-2541.
Ms. Patience testified that although the rehabilitation screen
notes the resident's contractures, it does not "correct" the
inaccurate information on the MDS, nor can it be used in place of
the MDS. Tr. 2541. HCFA argues that, more importantly, the MDS
does not contain the signature of the physical therapist, Donna
Hambright, who authorized the rehabilitation screen (see P. Ex. 20
at 3), and was "the one individual who apparently did at least
recognize the existence of [the resident's] contractures." HCFA
Br. at 40-41.
Petitioner argues that the surveyor's findings do not make a
reference to a failure of participation of any health professional
and thus do not constitute a violation of the regulation. P. Br.
at 59. Moreover, Petitioner contends that the surveyor's findings
"refer to an alleged inaccuracy in the assessment concerning a
patient's physical condition, i.e., the allegation is that the
assessment refers only to a balance problem whereas the resident
has joint contractures, progressive weakness, loss of mobility and
a decrease in the ability to transfer independently." P. Br. at
60-61. Petitioner argues that even if the comprehensive assessment
was inaccurate and did not correspond to the care plan, "the
alleged findings have nothing to do with the regulation in question
and there has therefore been no adequate notice of the deficiency
to which [P]etitioner is required to respond." P. Br. at 61.
Petitioner believes that the information regarding resident 13's
contractures and other physical problems was accurately assessed
because "this information was contained in a rehabilitation screen
performed by an appropriate health care professional. The
rehabilitation screen is part of the assessment." P. Br. at 60; P.
Resp. Br. at 17-19. Petitioner argues further that "there is
nothing in the record to indicate that the location of the screen
vis a vis in the MDS form or its contents adversely affected the
patient's health, i.e., no evidence of any negative outcome." P.
Resp. Br. at 19.
The purpose behind 42 C.F.R. 483.20(c) is to assure that the
appropriate health professionals complete a resident's assessment
accurately. As discussed earlier in this decision, the assessment
instrument is the MDS. The accuracy of the MDS is thus dependent
upon the appropriate health professionals completing the
appropriate sections. By signing their names to the MDS,
Petitioner's staff certifies that they have completed their
respective sections accurately and have acted in coordination with
each other in the formulation of the MDS.
I conclude that the rehabilitation screen is part of the assessment
process, but is not part of the assessment instrument. The
physical therapist, after completing resident 13's rehabilitation
screen, should have participated also in formulating the body
control problems section of resident 13's MDS. Although a LVN
completed the body control problems section on the MDS, she was not
the appropriate health professional to complete this section.
I find, however, that Petitioner's failure to involve a physical
therapist in the completion of the MDS did not negatively impact
the resident. The omission of contractures on the MDS did not
adversely impact the completion of the other sections because the
other sections appear to be accurately completed. P. Ex. 20 at 4.
It is therefore likely that Petitioner's staff did take into
account the fact that this resident has contractures. Moreover, on
the MDS, it appears that the appropriate actions were triggered,
i.e., it appears that Petitioner completed the appropriate RAPS for
this resident. Furthermore, the resident's care plan reflects his
contractures and is thus accurate. A care plan entry dated
December 10, 1993, noted that the resident had multiple joint
contractures and set forth objectives which included decreasing the
resident's knee contractures and increasing his ankle range of
motion. P. Ex. 20 at 8. I conclude that there is no evidence that
the resident suffered any harm or that a potential for harm
existed. While the failure to use a physical therapist to complete
the Body Control section of the MDS should have been brought to the
attention of Petitioner, it should not have been cited as a
deficiency. It clearly was a minor omission that did not
compromise the care of this patient. Accordingly, I find that
Petitioner did not violate 42 C.F.R. 483.20(c)(1).
H. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 295 (HCFA Ex. 2 at 7-9):
42 C.F.R. 483.20(d)(1) (1) The facility must develop a
comprehensive care plan for each resident that includes measurable
objectives and timetables to meet a resident's medical, nursing,
and mental and psychosocial needs that are identified in the
comprehensive assessment. The plan of care must deal with the
relationship of items or services ordered to be provided (or
withheld) to the facility'
responsibility for fulfilling other requirements in these
regulations. 64/
*****
Based on observation, interviews, and medical record review it
was determined that staff failed to develop a comprehensive care
plan for each resident based upon the comprehensive assessment.
Findings include:
Resident #1 was admitted to the facility on 2/1/93. The
physician wrote an order on 2/11/93 that she may self administer
medications and to store them at her bedside. Neither of these
special needs were addressed on resident #1's plan of care until
12/2/93. Approaches for the self administration of medication and
bedside storage included the following:
1. Ordered 2/11/93 may have own medications at bedside.
2. Check with resident about the time in administering
medication.
3. Check the medication container by the date the medication
was taken.
4. Count the medication in the bottle and log it as she took
it.
5. Monitor as scheduled in administering her meds. Educate
resident re: self administration of meds: Remind to be careful with
self administration of meds; to list the meds she have [sic] taken
each day.
6. Observe resident for an [sic] unusual occurrences and
remind resident to report to charge nurse if complaints of
persistent headache, projectile vomiting, increased temp, etc.
Interviews with licensed nurses and resident #1 revealed that
this resident refused to allow nurses to observe her administer her
medications. She also refused to let the nurses check her
medication bottles. The facility failed to develop the approaches
to address her needs for 10 months and failed to follow the plan of
care after it was developed.
Medical record review revealed inconsistencies between the
assessments, RAPS, and patient care plan indicating a lack of
coordination of information collected during the assessment process
as well as the evaluation of the care needs from the entire
interdisciplinary care team. The patient care plan must reflect
the residents care needs as reflected by the ongoing assessment and
changing needs.
Cross Reference - F297
Petitioner argues that it did develop a care plan for resident 1.
P. Br. at 67. Petitioner contends that HCFA's criticism is based
on "an alleged failure to follow the developed care plan, which is
not a violation of the regulation." Id. Moreover, Petitioner
asserts that it did follow the care plan. It further argues that
"[n]one of [the witnesses'] testimony has anything to do with the
development of a comprehensive care plan but rather with its
implementation or modification." P. Br. at 80.
At the hearing, Ms. Shekell testified that she did not write this
deficiency. Tr. 432, 836. She stated that the deceased surveyor,
Ms. Chute, had prepared this deficiency. Tr. 369.
Ms. Shekell testified that the actual description of the deficiency
in the HCFA 2567 is set forth at page 9 of HCFA Ex. 2 and begins
with the sentence "Interviews with licensed nurses and resident #1
revealed that this resident refused to allow nurses to observe her
administer her medication. . ." Tr. 386-387, 391-392. Ms. Shekell
stated that she was not present when the interviews with the
licensed nurses and resident 1 occurred. Tr. 397. She did not
know what particular time period had been discussed in Ms. Chute's
interviews with the nurses. Tr. 408. Ms. Shekell testified that
she did not discuss with Ms. Chute what was said at those
interviews. Tr. 397-398. Ms. Shekell testified further that she
"remember[ed] Miss Chute during our team meetings discussing with
the team that she had identified a patient that was taking her
medications without being properly monitored." Tr. 399.
In describing the deficiency, Ms. Shekell testified as follows:
"Well, they have stated in their approach that they are going to
monitor and check the patient and count the medications and then
they couldn't do that. So then they needed to develop another Plan
of Care that, so that they could adequately monitor the
medications." Tr. 402. In addition, this testimony was elicited
from her:
A [Ms. Shekell]: As I stated yesterday, I am reviewing this
record in the absence of the evaluator that wrote the deficiency.
It is not totally clear to me what she meant by the 10th month. I
can only make the assumption that the original physician's order
was written that the patient may have her meds at the bedside, was
written on February the 11th and was -- this care plan was
initiated on 12-2, approximately 10 months lager [sic].
Q [Counsel for Petitioner]: And so you're making the
assumption that the care plan was initiated as a result of an entry
made 10 months before. Am I understanding you rightly?
A [Ms. Shekell]: That's what it appears to me.
Tr. 825.
In response to my inquiry whether a care plan should have been
prepared in response to the physician's 2/11 order, Ms. Shekell
responded "[t]hat's -- yes there should have been." Tr. 414-415;
see Tr. 2556-2557 (testimony of Ms. Patience). Ms. Shekell
testified that the only care plan she had before her was the one
dated December 2, 1993. She stated "[i]f I had the entire medical
record, I would be able to tell you whether they had developed one
and then discarded it and then developed another one." Tr. 415.
In questioning Ms. Shekell, counsel for Petitioner indicated that
the only care plan that was prepared for this resident reflecting
self medication was the plan of care completed on December 2, 1993.
Tr. 417.
It appears that the surveyor determined that Petitioner had
violated the regulation cited here because (1) Petitioner failed to
care-plan the physician's order of February 11, 1993 that she "may
have own meds at bedside" until approximately ten months later, on
December 2, 1993; (2) once it became apparent that the December
care plan approaches could not be successfully carried out due to
resident 1's refusals and her own physical condition, Petitioner
should have, but failed, to develop a care plan for resident 1 that
enabled Petitioner's staff to effectively monitor her taking of her
medications; and (3) despite the statement in the 12/2/93 care plan
that Petitioner's staff would monitor resident 1's administration
of her medication, no monitoring of resident 1's bedside
medications occurred until December 6, four days later.
The medical chart for resident 1 which has been admitted into
evidence contains a physician's order dated 2/11/93 which states
that she "may have own meds at bedside." P. Ex. 21 at 29. 65/
Based on the record, however, there is no indication that
Petitioner's staff contemporaneously care-planned the 2/11/93
physician's order. Although resident 1's medical chart does
contain an earlier care plan containing February 1993 entries,
nowhere on this care plan does Petitioner mention the 2/11/93
order. See P. Ex. 21 at 12. The February 1993 care plan would
have been an appropriate document in which Petitioner could have
contemporaneously noted the 2/11/93 physician's order. However,
the record contains only a 12/2/93 care plan relating to
self-medication. P. Ex. 21 at 30.
On this 12/2/93 care plan (P. Ex. 21 at 30), in the left-hand
column ("patient problems/needs"), Petitioner's staff has written
"Info.: Administer some of her medications. Info.: may have own
meds @ bedside (as ordered)." Petitioner's staff wrote also that
there was a "potential for taking too many meds too often." P. Ex.
21 at 30. In the far right column ("Approaches/Actions") of the
care plan, Petitioner's staff listed the "approaches/actions" to be
followed with respect to resident 1's self-administration of
medication. Id. The first "approach/action" states: "Ordered
2/11/93 may have own meds @ bedside." (emphasis added). The other
"approaches/actions" focused on such things as checking resident 1
with respect to the time for administering her medicines, counting
the medication in the bottles and logging it as she took it, and
monitoring her as scheduled. Id. (I will not repeat verbatim the
approaches here because they were included among the findings in
the HCFA 2567, which I have already listed above.)
The regulation requires that Petitioner have a care plan in place
that "includes measurable objectives and timetables to meet a
resident's medical, nursing, and mental and psychosocial needs" and
describes the "services that are to be furnished to attain or
maintain the resident's highest practicable physical, mental, and
psychosocial well-being." This Petitioner did not do, for it
failed in February 1993 to contemporaneously care-plan the
physician's 2/11/93 order that resident 1 could have her own
medications at bedside, in violation of 42 C.F.R. 483.20(d)(1).
Resident 1's medical chart contains also two assessment forms
titled "Self-Administration of Medication Assessment", dated April
1, 1993 and December 2, 1993. P. Ex. 21 at 26-27. 66/ According
to the April 1, 1993 assessment, which was signed by a licensed
nurse and a physician, resident 1 was evaluated as not being
mentally or physically able to administer medication. P. Ex. 21 at
27. Petitioner's staff wrote that she "gets confused about
medication being given. [O]ften forgets" and concluded that she
was not a candidate for safe self-administration of medications.
Id. Following this assessment, HCFA argued, in effect, that
Petitioner was obliged to develop a care plan which set forth
measurable objectives and timetables correlating to resident 1's
status that she should not be permitted to self-administer
medications. 67/ See Tr. 2557. Counsel for HCFA seeks such a
finding. HCFA Resp. Br. at 28. I am unwilling to make this
finding because there is no reference in the HCFA 2567 relating to
any intervening circumstances warranting additional care plans.
Petitioner has not been put on notice of this particular alleged
deficiency. I indicated to the parties that I would construe
these deficiencies in a manner consistent with the due process
principles of notice and opportunity to defend. 68/
According to the assessment dated December 2, 1993, which also was
signed by a licensed nurse and a physician, resident 1 wished to
self-administer medications. P. Ex. 21 at 26. She was found
mentally and physically able to do so. Petitioner's staff
concluded that resident 1 was a candidate for safe
self-administration of medications. Id.
Petitioner argues that the 12/2/93 care plan entries (discussed
above) were written in conjunction with this 12/2/93
self-administration assessment. P. Br. at 73. I have nothing in
this record which allows me to identify with any certainty what was
the precise trigger for the 12/2/93 care plan. Whether it was the
2/11/93 physician order or the 12/2/93 assessment, once Petitioner
was aware of the 2/11/93 order, it should have initiated a care
plan consistent with such order. This was not done. Moreover,
Petitioner's contention is plainly inconsistent with the fact that
the 12/2/93 care plan specifically mentions the 2/11/93 physician's
order. 69/
It is not entirely clear from reading the HCFA 2567 as to when
resident 1 refused to allow nurses to observe her taking her
medicines and to check her bottles. However, I note that, as part
of resident 1's medical chart, Petitioner included her medication
record for December 1993 (P. Ex. 21 at 31-34). 70/ Additionally,
there is an interdisciplinary team note dated 11/30/93 which
states, in part, "Resident chose not to attend PCP. All
disciplines present & participated. . . Refusal of antibiotic
discussed." (At the end of this entry, there are four signatures.)
P. Ex. 21 at 28. My discussion will thus focus on these particular
documents.
Resident 1's December 1993 medication record (P. Ex. 21 at 31-34)
establishes that there were instances in December when resident 1
refused to allow Petitioner's staff to monitor her
self-administration of her medications. In explaining the
medication record, Ms. Shekell stated that the initials in the
boxes belonged to whichever nurse had been providing the care
during that particular shift. Ms. Shekell testified that the
initials, when present, were "supposed to mean" that the nurse
"either saw the patient take the medication or administered the
medication." Tr. 421. She testified further that a circle around
an initial "would normally indicate that the patient refused the
medication" and could also represent that the patient "refused to
allow monitoring of the medication." Tr. 422. Elsewhere, Ms.
Shekell elaborated that, if a medication "is not given, it's
circled" and "the reason for is documented other -- some place else
in the medical record." Tr. 426-427. 71/
On one page of resident 1's December 1993 medication record is
listed the medicines Riopan Plus, Robitussin, and Sucrets. Under
each of these medicines, Petitioner's staff has written "may keep
at bedside and monitor q shift." P. Ex. 21 at 31. 72/ Among the
charting notations for these medicines, however, one finds
instances where circled initials were recorded. 73/ Thus, based on
this evidence, resident 1 apparently refused several times to allow
Petitioner's staff to monitor her self-administration of
medications.
Petitioner's counsel argues that "[t]he number of instances where
there was refusal to permit monitoring of self-medications compared
with the number of instances where the care plan was followed and
monitoring occurred, did not justify a change in the comprehensive
care plan." P. Br. at 68. I find unpersuasive Petitioner's
argument. Although Ms. Shekell appeared to agree with Petitioner's
counsel that resident 1 "refused a very small number of times out
of the total" (Tr. 423), the fact remains that refusals did occur.
Such refusals on the part of resident 1 were not minor or
inconsequential. Resident 1's actions of non-compliance directly
conflicted with the 12/2/93 care plan approaches. Ms. Shekell
testified:
And then this care plan was not further developed when they
saw that they couldn't -- that it was ineffective. In other words,
staff could not monitor, the patient wouldn't let them count her
medications.
Tr. 417.
Further evidence concerning the difficulty in carrying out the
12/2/93 care plan approaches is found in the Social Services notes.
The Social Services note dated 12/17/93 indicates that the resident
"apparently fell while trying to get more robitussin." It states
also that the resident agreed that "she should request help
considering her weakened state." Lastly, the resident requested
more Pepto Bismol, but could not remember when she had last taken
it. P. Ex. 21 at 21.
Once it was ascertained that the 12/2/93 care plan approaches could
not be carried out successfully due to resident 1's refusals and
her own physical condition, Petitioner should have developed a new
care plan which addressed fully resident 1's current needs. There
is no evidence of a care plan that mentions the problems of
resident 1's refusals and her physical inability to self-administer
medicines or addresses how to adequately monitor her taking of
medications in light of these problems and difficulties.
Petitioner's failure to develop a new care plan on these grounds
establishes further that it violated 42 C.F.R. 483.20(d)(1).
With respect to HCFA's claim that Petitioner didn't start to
monitor resident 1's medications (P. Ex. 21 at 31) until December
6, four days after the 12/2/93 care plan was written (Tr. 681), I
find that this allegation goes to the implementation of the care
plan and not to the development of a care plan. It is the latter
which is the focus of the regulation at issue here. Therefore, I
do not make any findings on this allegation.
Petitioner argues that "there is no evidence that resident no. 1
was adversely affected because of what was or was not in the care
plan document, i.e., no evidence of any adverse outcome." P. Resp.
Br. at 21. Petitioner's assertion fails to consider that actual
harm to a resident need not be shown to find a deficiency. As Ms.
Shekell testified, ". . . the care plan is to reflect at all times
the care needs of the patient." Tr. 699. By leaving a misleading
and inaccurate care plan in place, thereby representing it to be
accurate and up-to-date, Petitioner potentially could have
jeopardized resident 1's health, safety, and well-being. Here,
Petitioner's difficulty in monitoring resident 1's
self-administration of medication could have resulted in the
resident "either over- or under-dos[ing] herself." Tr. 2548
(testimony of Ms. Patience). In fact, this potential danger did
occur, for resident 1 could not remember when she had last taken
Pepto-Bismol. 74/ It is of little consequence that resident 1 may
have experienced no actual harm.
The latter part of the alleged deficiency as written in the HCFA
2567 stated: "Medical record review revealed inconsistencies
between the assessments, RAPS, and patient care plan indicating a
lack of coordination of information collected during the assessment
process as well as the evaluation of the care needs from the entire
interdisciplinary care team. The patient care plan must reflect
the residents care needs as reflected by the ongoing assessment and
changing needs." HCFA Ex. 2 at 9. I find that this part of the
deficiency also has been proven by HCFA.
As I have described above, resident 1's medical chart establishes
that she had changing care needs with respect to
self-administration of medication. Her care plan should have been
consistent with any physician's orders and should have reflected at
all times her current care needs. The fact that Petitioner did not
prepare a care plan to implement the February 1993 physician's
order contemporaneously with that order and, also, did not develop
a new care plan once it became apparent that the care plan
approaches could not be successfully carried out, demonstrates a
lack of coordination of information and inadequate evaluation of
her care needs.
To address further HCFA's claim that there were inconsistencies
among the documents, I have reviewed the following: the medication
assessment forms (discussed above), which are dated 4/1/93 and
12/2/93; an MDS dated 8/31/93 (P. Ex. 21 at 2-5); an MDS dated
2/15/93 (P. Ex. 21 at 22-25); a quarterly review dated 11/30/93 (P.
Ex. 21 at 7-8); and Social Services notes.
HCFA argued that resident 1's assessments, "as contained in the
self-medication forms and the MDS, are inconsistent with other
information in the record regarding her confusion and
forgetfulness." HCFA Resp. Br. at 26. The Social Services notes
(see P. Ex. 21 at 17-19) state that the resident exhibited yelling
and screaming on 10/4/93, 10/8/93, and 11/15/93, and, also,
manifested confusion on 10/8/93 (P. Ex. 21 at 18). The written
entry dated 11/29, in addition to mentioning the resident's
forgetfulness, stated also "She continues to make most of her own
decisions, but experiences a lot of frustration over the process.
[The resident] experiences a lot of anxiety. . . and often ends up
yelling at the staff . . ." P. Ex. 21 at 19-20. This entry
appears to be a summary of the resident's recent behavior as
documented in the previous Social Services notes.
Nowhere on the 11/30/93 quarterly review is there any indication
that the resident had any mood or behavior problems. P. Ex. 21 at
7-8. I realize that, in accordance with the printed instructions
on the quarterly assessment document, the relevant time frame for
purposes of assessing resident 1's mood and behavior patterns was
the last seven days prior to the date of the quarterly review
which, in this case, would be 11/24/93 - 11/30/93. However, in
light of resident 1's recently documented behavior of yelling,
screaming, and anxiety, this quarterly review is inconsistent with
the Social Services notes and does not appear to reflect an
accurate assessment of resident 1. 75/
Additionally, both the MDS dated 2/15/93 and the MDS dated 8/31/93,
indicate in Section H that resident 1 had exhibited "verbal
expressions of distress" during the last 30 days and had
demonstrated a "failure to eat or take medications, withdrawal from
self-care or leisure activities." P. Ex. 21 at 4, 24. 76/ This
earlier documentation of resident 1's distress, together with the
10/93 and 11/93 Social Services notes discussed above, further
support a conclusion that the accuracy of the 11/30/93 quarterly
review is questionable with respect to its assessment that resident
1 had no mood or behavior problems. 77/
I find that resident 1's mood and behavior problems should have
been reflected in the 12/2/93 care plan. Petitioner's failure to
do so constitutes a further violation of 42 C.F.R. 483.20(d)(1).
Although resident 1 was assessed as being competent to
self-administer medications according to the 12/2/93 medication
assessment, nevertheless, I find that the care plan should have
indicated her mood and behavior problems and addressed them in the
context of self-administration of medications. The care plan was
thus arguably inconsistent with what was documented in the Social
Services notes which I discussed above. A revisiting of the
determination that resident 1 was capable of self-medication may
have been warranted in light of the incidents of exhibited
distress. The absence of such care plan provisions had the
potential to negatively impact this resident since, without
addressing these mental problems, the resident was prevented from
achieving her highest practicable level of mental and psychosocial
well-being. Moreover, failure to treat these mental problems could
potentially place this resident in danger of compromising her
health from either an overdose or under dose of medication.
I. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 297 (HCFA Ex. 2 at 9-11):
42 C.F.R. 483.20(d)(2) (ii) Prepared by an interdisciplinary
team, that includes the attending physician, a registered nurse
with responsibility for the resident, and other appropriate staff
in disciplines as determined by the resident's needs, and, to the
extent practicable, the participation of the resident, the
resident's family or the resident's legal representative;
*****
Based upon observation, interview and medical record review it
was determined that staff failed to use an interdisciplinary
approach to the evaluation of resident status.
Findings include:
Resident #1 was admitted to the facility 2/1/93. In February,
1993, an order was written by her physician that said sh [sic]
could self medicate and have her medications at her bedside. In
April, 1993, a "self administration of medication assessment" was
completed and she was not found to be a candidate for
self-administration of medications.
On 12/2/93 a second "self-administration of medication
assessment" was completed and signed by a physician and a licensed
nurse. She was found to be a candidate for self administration of
medication at that time. The facility failed to follow their own
policy and procedure 'Review of bedside medications and self
administration' which requires the involvement of an
interdisciplinary team in the assessment, care planning and
monitoring of the resident for self administration and bedside
storage of medication.
Cross Reference - F292
It was evident through medical record review that all
disciplines did not participate in the evaluation and assessment of
each resident on a quarterly basis or as needed.
Cross Reference - F295
42 C.F.R. 483.20(d)(2)(ii) pertains to the utilization of an
interdisciplinary team in the preparation of a resident's care
plan. The findings set forth in the HCFA 2567 (re-stated above) in
support of this alleged deficiency relate to resident 1's
"self-administration of medication" assessments. There is nothing
in the findings that identifies Petitioner's conduct in
contravention of the requirements of 42 C.F.R. 483.20(d)(2)(ii),
which are limited to a resident's care plan.
The evidence offered by HCFA in the HCFA 2567 relating to Resident
1's assessments is extraneous and goes beyond the regulation at
issue. In its brief, however, HCFA discusses resident 1's
assessments and her 12/2/93 care plan (HCFA Resp. Br. at 29-30)
although this care plan was not mentioned at all in the findings in
the HCFA 2567.
In fairness to Petitioner, HCFA's presentation of the evidence in
support of this alleged deficiency is an example of the "moving
target" approach which Petitioner has accused HCFA of taking at
times. I do not accept HCFA's attempt to establish the existence
of this deficiency by evidence which is wholly unrelated to the
findings set forth in the HCFA 2567. Although the regulation
relates to care plans, the basis of the deficiency, as written in
the HCFA 2567, concerned resident 1's assessments, not her care
plan. While in the course of the hearing I allowed HCFA at times
to amplify the factual elements of a deficiency, there was, with
respect to those deficiencies, sufficient information given in the
HCFA 2567 to put Petitioner on notice of the alleged conduct being
challenged which violated the referenced regulation. Here, there
are insufficient facts in the deficiency relating to care plans to
put Petitioner on notice as to its conduct which was out of
compliance with 42 C.F.R. 483.20(d)(2)(ii). HCFA goes beyond
mere amplification of the facts in the deficiency. It introduces
evidence supporting the cited regulatory violation that was not
alleged in the HCFA 2567. No amendment of the HCFA 2567 was ever
sought by HCFA. Consequently, any attempt by HCFA to go beyond
what was charged in the HCFA 2567 is for naught.
Moreover, HCFA relied on the findings set forth in the HCFA 2567,
which have no relation to the language of 42 C.F.R.
483.20(d)(2)(ii), to prove that Petitioner was out of compliance
with this regulation. This reliance is misplaced. Resident 1's
"self-administration of medication" assessments have nothing to do
with her care plans. Further, although F 295 cross-references F
297 (HCFA Ex. 2 at 9), the findings pertaining to F 295, set forth
in the HCFA 2567, do not support the existence of a violation of
the regulation on which F 297 is based.
The only reference to care-planning in the deficiency related to a
general allegation of Petitioner's failure to follow its own
internal procedure which requires the involvement of an
interdisciplinary team in the assessment, care-planning, and
monitoring of the resident for self-administration and bedside
storage of medication. The deficiency fails to state with
sufficient particularity the care plan in issue, and the make-up of
the interdisciplinary team who prepared such care plan and how that
grouping was in violation of the cited regulation. The individuals
identified in the deficiency pertained to the resident's assessment
for self-administration of medication. No information is provided
as to individuals who participated in the care plan, nor is there
a reference to a specific care plan. Such information is basic to
establishing a violation of the cited care plan regulation.
Accordingly, Petitioner did not violate 42 C.F.R.
483.20(d)(2)(ii).
J. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 298 (HCFA Ex. 2 at 11):
42 C.F.R. 483.20(d)(2) (iii) Periodically reviewed and revised
by a team of qualified persons after each assessment.
*****
Based on observation, staff and resident interview, and
medical record review it was determined that the careplan did not
reflect current assessment of each resident.
Findings include:
Resident 20 was observed on 12/20/93 sitting up in a chair.
He had a Linard sitting [sic] system in place, however he was
leaning to one side and appeared very uncomfortable. Licensed
staff reassessed the resident and changed positional devices, and
the resident told this evaluator that he was more comfortable. The
plan of care was not updated to reflect this change.
HCFA relies to a great extent on the testimony of Ms. Cox for proof
of this deficiency. Ms. Cox stated that she and a staff member
observed resident 20 as they walked by him and saw that he was "in
very poor bodily alignment. He was slumped forward to the side."
Tr. 1061. Ms. Cox stated that she and the staff member "stopped
and looked at him." Id. Ms. Cox testified further:
I talked to the resident. He said -- after I asked him if he
would [sic] was comfortable in that position which he certainly
appeared not to be, he did say that he was not comfortable. The
licensed person with me went and got either an occupational
therapist or a physical therapist, had her come, look at him right
then when I was there. She said that the system that they were
currently using was not working for him and that she would find
something else that did work for him.
She in fact did find something else. They changed the chair.
They used kind of an -- I'm not sure what it's called but it's a
saddle type of thing to keep him from sliding down, and the chair
that they replaced kept him sitting more upright.
He himself verbalized that he was more comfortable with the
new system that they had given him . . . .
Tr. 1061-1062.
According to Ms. Cox, Petitioner then failed to change the
resident's care plan to show that a new system had been started
with him. Tr. 1062. 78/ Ms. Cox expressed concern that, because
Petitioner's staff left the old care plan in place, there was a
possibility that the resident would be put back on the old system.
Id.
In response to this cited deficiency, Petitioner argues that "the
evidence is in sharp dispute as to whether the seating system was
changed or whether there was only an adjustment causing the patient
to sit more upright." Moreover, "[t]here is a failure of proof to
indicate that any modification or change which occurred required a
change in the seating system necessitating a change in the plan of
care." P. Br. at 83.
HCFA and Petitioner do not dispute that a postural seating system
was being used on resident 20 at the time Ms. Cox observed him.
This seating system, according to
resident 20's medical chart, was instituted pursuant to a
physician's order dated September 28, 1993 which states: "Postural
seating system when OOB [out of bed] for body alignment and safety
in w/c [wheelchair]. DC [Discontinue] previous order for safety
bar when in w/c . . ." P. Ex. 23 at 4. 79/ Petitioner's staff
noted this order in the care plan also. Id. at 12.
Although the care plan does not specify the type of seating system
used on resident 20, Ms. Cox has alleged, and Petitioner does not
appear to deny, that the seating system which was in place for
resident 20 at the time of Ms. Cox's observation was a Linard
seating system. Tr. 1308. 80/
I accept Ms. Cox's testimony relating to this deficiency and find
that the scenario involving resident 20 occurred as Ms. Cox
described it. Petitioner presented no testimony from anyone on its
staff who was present at the time of Ms. Cox's observation of
resident 20 to contradict her testimony. Petitioner could have
offered the testimony of the staff members who were directly
involved in the reassessment of resident 20, but it did not do so.
Moreover, while Ms. Downing did testify concerning her review of
resident 20's medical chart and about seating restraints in
general, she was not present when Ms. Cox observed resident 20 and
thus has no first-hand knowledge of this incident. 81/
After resident 20 voiced his discomfort, I find that Petitioner's
staff undertook significant steps to maintain resident 20's proper
posture and comfort level. Contrary to Ms. Downing's assertion
that there was no change in resident 20's seating system,
Petitioner's staff did change positional devices to alleviate his
discomfort and help him sit upright. Petitioner's staff removed
the Linard seating system (Tr. 1308, 1310), put resident 20 in a
"saddle type of thing to keep him from sliding down," and replaced
his chair with one that "kept him sitting more upright." Tr. 1062.
Thus, it cannot be said that resident 20's existing seating system
remained the same. I conclude that the changes made by
Petitioner's staff were significant and constituted more than a
simple re-adjustment of resident 20's existing seating system. 82/
As such, Petitioner's staff was required to update resident 20's
care plan contemporaneously to reflect this change. Ms. Cox
testified that she checked the care plan between Dec. 20 and Dec.
23 to see if resident 20's care plan had been updated to reflect
the change in positioning devices, and it had not. Tr. 1067. By
its failure to revise resident 20's care plan, Petitioner did not
comply with 42 C.F.R. 483.20(d)(2)(iii).
In elaborating on its arguments, Petitioner contends that the
saddle is not considered to be part of a seating system and that
the addition of a saddle would not constitute a change to the
seating system per se. Tr. 1921, 2315-2316; P. Br. at 87-88; P.
Resp. Br. at 23-24. Moreover, Petitioner contends, the saddle "was
added months after the event in question and not at the time [Ms.
Cox] claimed". P. Br. at 85. 83/ Petitioner is apparently
referring to resident 20's plan of care, which does indicate that
a "western saddle" was added on 4/12/94 (P. Ex. 23 at 12). 84/
I do not agree with Petitioner that the addition of a saddle device
could not have occurred earlier, as Ms. Cox described in her
testimony. The existence of the 4/12/94 entry in the care plan
does not disprove Ms. Cox's testimony that a saddle was added to
resident 20 at the time of the survey in December 1993. It is
noteworthy that Petitioner, who had all of resident 20's medical
records in its possession, could not produce any care plan entry
dealing with seating systems that was made contemporaneously at the
time of the December 1993 survey. Petitioner produced only the
April 1994 care plan entry, which is irrelevant. Given that I find
some sort of a saddle device was added in December 1993, the
4/12/94 entry in resident 20's care plan does not negate the
failure on the part of Petitioner's staff to indicate in the care
plan in December 1993 that a saddle was added.
Moreover, I cannot conclude whether it was a western saddle that
was used on resident 20 in December 1993. Notwithstanding this,
whether the western saddle mentioned in the April 1994 care plan is
the same device that was used on the resident in December 1993 is
irrelevant to the issue of whether resident 20's care plan
reflected a current assessment in December 1993.
As further support that there was a change in positional devices,
as alleged in the HCFA 2567 ("Licensed staff reassessed the
resident and changed positional devices . . ." (emphasis added)
(HCFA Ex. 2 at 11), Ms. Downing stated that both the Linard system
and the saddle could be described as positional devices (Tr. 2315,
2316). Thus, in light of this statement, the reference in the HCFA
2567 to a positional device could very well be a reference to the
addition of a saddle device to resident 20, despite Petitioner's
claims that no such event occurred.
At the hearing, I pointed to the plan of correction submitted by
Petitioner in response to this alleged deficiency and noted that it
stated, in part, "The resident's care plan has been updated to
reflect changes." HCFA Ex. 2 at 11. 85/ In response to my inquiry
as to whether resident 20's care plan had been updated to reflect
the change, Ms. Downing was unable to point to anything in resident
20's care plan which could possibly corroborate this statement.
Instead, Ms. Downing interpreted the statement I quoted above as
referring to a September 1993 entry in the care plan and stated
"that's what they were emphasizing." Tr. 1933-1934. I find Ms.
Downing's testimony rather puzzling and confusing in light of the
fact that this alleged deficiency involving resident 20 occurred
during the survey in late December 1993. Any care plan change
dated prior to December 1993, while it could possibly be considered
an "update" to the care plan, would not have any relevance to this
alleged deficiency nor would it be considered as a remedial action
in response to the deficiency. Ms. Downing's statement can be
construed only as further proof that Petitioner did not update
resident 20's care plan following the change in December 1993 in
his positional devices. The statement in Petitioner's plan of
correction is apparently uncorroborated by the record before me.
86/
Petitioner contends that there is no evidence to show that resident
20's health or safety was adversely effected. P. Resp. Br. at 24.
While this may be true, I find that there existed the potential of
harm to resident 20. As I stated earlier, under OBRA, Petitioner
is responsible for providing residents with services necessary to
attain or maintain their highest practicable physical, mental, and
psychosocial well-being as required under 42 C.F.R. 483.25. In
order to maintain resident 20's proper alignment, Petitioner's
staff implemented a significant change from his pre-existing
seating system. It was necessary for this change to be
care-planned to ensure that other caregivers on Petitioner's staff
would know that they should implement it on a daily basis to
maintain his highest practicable physical well-being. However,
because resident 20's care plan did not indicate the change in
positional devices that occurred on December 20, 1993, it was
likely that other caregivers, not knowing what had been done and
assuming the care plan to be up-to-date, would have put him back
into his old seating system, which had been determined to be
ineffective and uncomfortable. Such a result could have had a
detrimental effect on resident 20's health and safety and would
have contravened the very purpose of OBRA.
The regulation requires that the comprehensive care plan must be
periodically reviewed and revised after each assessment. This was
not done here with respect to resident 20's care plan, in violation
of 42 C.F.R. 483.20(d)(2)(iii). Moreover, such failure had the
potential to negatively impact this resident recited above.
Consequently, HCFA has met its burden of proof in establishing this
deficiency.
K. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 300 (HCFA Ex. 2 at 11-13):
42 C.F.R. 483.20(d)(3) (ii) Be provided by qualified persons
in accordance with each resident's written plan of care.
*****
Based on record review, observation, and interview, the
facility failed to provide services by qualified persons in
accordance with each resident's plan of care.
Findings include:
Resident 24 has a physician's order for an E-Z boot to be
applied by nursing staff daily from 8 P.M. as tolerated. Review of
his treatment record revealed that licensed staff was documenting
that the boot was not available for use and has not been applied
since it was ordered on 12/9/93. Licensed staff was observed by
this evaluator when they entered the resident's room to search for
the boot. The boot was found in his bedside stand. There was no
explanation why the boot had not been used and no monitoring system
was in place to insure the plan of care was followed.
Resident 8's plan for care dated 12/1/93 indicates that he
requires 1700 CC's of fluid over a 24 hr. period. The resident had
a diagnosis of recent pneumonia and current stage 3 decubitus.
Review of the intake records from 12/2/93 to 12/19/93 revealed that
the resident's intake only met the 1700 cc goal 2 days out of the
two week period. The majority of days the resident's intake was
less than 1500 cc's over a 24 hr. period and as low as 890 cc on
12/13/93 and 740 cc on 12/19/93. Licensed nurse's notes did not
address failure to meet this resident's fluid needs, and in fact
stated there was no problem. This resident was at high risk for
further skin breakdown and reoccurring pneumonia, if hydration is
not monitored and maintained.
1. Resident 24
According to the HCFA 2567, resident 24 had "a physician's order
for an E-Z boot to be applied by nursing staff daily from 8 P.M. as
tolerated." HCFA Ex. 2 at 12; see P. Ex. 24 at 2. Review of this
resident's treatment record revealed that Petitioner's staff
documented in this resident's record that the boot was not
available for use and had not been applied since it was ordered on
December 9, 1993. HCFA Ex. 2 at 12; see P. Ex. 24 at 11, 12. The
resident's treatment record from December 10 through December 23,
1993, provides notations for each day during this period indicating
that the E-Z boot was "missing" or "unavailable." P. Ex.
24 at 12.
During the survey, Ms. Cox observed that 1) the boot was found in
the resident's bedside stand, 2) no explanation was offered as to
why the boot had not been used, and 3) no monitoring system was in
place to ensure that the plan of care was followed. Tr. 1069-1070.
Ms. Cox described an E-Z boot as "a system that they use to either
prevent contracture of the ankle or sometimes they also put them on
just to protect the heels or to keep the foot in a certain
position. I've seen them used for multiple different things." Tr.
1072. Ms. Cox stated that failure to apply the boot as ordered
could have adverse consequences on the resident's health. Id.
Petitioner does not dispute the facts relating to the E-Z boot
cited in the deficiency, which were based on Ms. Cox's
observations. P. Resp. Br. at 24. Rather, Petitioner argues that
proof of a deficiency has not been established in this record.
First, Petitioner argues that the surveyor could not state at the
hearing what was in the care plan relating to application of the
E-Z boot. P. Br. at 90. Second, the plan of care is not in the
record and there is no evidence that it covered use of an E-Z boot.
P. Resp. Br. at 24-25. Third, Petitioner contends that failure to
follow a physician's order is not violative of the cited regulation
since the regulation pertains to care plans. Id. at 25. Fourth,
Petitioner argues that, even if a deficiency could be found, it was
corrected before completion of the survey and, as a result, no
deficiency should have been cited. P. Br. at 89. Last, Petitioner
argues that HCFA has shown no pattern or negative outcome to the
resident. P. Resp. Br. at 25.
I agree with Petitioner that 42 C.F.R. 483.20(d)(3)(ii) relates
to failure to provide services in accordance with the resident's
plan of care. HCFA did not place in evidence a plan of care which
implements the physician's order requiring use of the E-Z boot.
However, such absence does not amount to a failure of proof. While
Ms. Cox could not recall at the hearing what the plan of care said
about application of the E-Z boot, she did testify that she
reviewed the care plan in connection with preparation of her
findings.
This deficiency was written because I did a record review. I
observed the resident and I interviewed facility staff and when all
after I had looked at the record and the Care Plan [emphasis added]
and I asked facility staff -- When I observed him he didn't have
his easy [sic] boot on as it was ordered by the physician or as it
was Care Planned [emphasis added], . . .[she went on to describe
the undisputed facts in this deficiency.] . . . So obviously they
didn't follow their plan of care and nobody was familiar with the
fact that the boot was right in his closet . . . .
Tr. 1069-1070.
Besides such testimony, my review of this resident's records,
including the minimum data set, quarterly review, rehabilitation
screen and physician's order, leads me to conclude that a care plan
was developed for this resident which carried out the physician's
order for application of the E-Z boot. P. Ex. 24. These documents
establish that the resident had contracture of his lower
extremities which would necessitate treatment and which would have
triggered preparation of a plan of care which would have included
the physician's order for application of the E-Z boot. Id. at 2-4,
6, 9.
Even without the presence of the care plan in evidence, there is
sufficient evidence to create a strong inference that such plan
existed and was relied on by Ms. Cox in preparing her findings.
While Petitioner's counsel may have shown that Ms. Cox had no
recollection of the specifics of the care plan at the hearing (Tr.
1327), such failure of recollection does not negate the weight of
other evidence in the record suggesting the existence of the care
plan and that it implemented the physician's order relating to use
of the E-Z boot on this resident. Moreover, I do agree with HCFA's
position that, if Petitioner contends that the care plan did not
cover the E-Z boot, it should have put the care plan in evidence.
87/ HCFA Resp. Br. 35-36. No such care plan was submitted by
Petitioner. Therefore, based on the record as a whole, I find that
Petitioner failed to carry out the physician's order in accordance
with the resident's care plan. This failure is precisely the type
of conduct that the cited regulation was promulgated to cover.
Petitioner argues that even assuming the regulation was violated,
the deficiency was corrected prior to completion of the survey. I
do not agree. The violation goes beyond mere placing of the E-Z
boot on the resident; it includes also the absence of a monitoring
system to ensure that the care plan was followed. See HCFA Ex. 2
at 12; Tr. 2584-2585. Arguably, the failure to have a monitoring
system in place led to Petitioner's failure to locate the E-Z boot
until the surveyor directed the attention of the staff to its
absence. This conclusion is supported by the nurses' treatment
notes indicating that, from December 10 through December 21, 1993,
the E-Z boot was either missing or unavailable. P. Ex. 24 at 12.
It appears that Petitioner's staff did nothing to locate the
missing boot nor take steps to get a new boot. Tr. 1069-1070; P.
Ex. 24 at 11-12.
Petitioner has not contended nor can I find in this record any
evidence that a monitoring system was in place or put in place at
the time of the completion of the survey. Without such a system in
place, there is no assurance that the circumstances of this
deficiency would not be repeated with other residents. Thus, I
cannot find that this deficiency was corrected at the completion of
the survey.
Lastly, Petitioner argues that there is no evidence of a pattern or
negative outcome resulting from this deficiency. Again, I do not
agree. The lack of a monitoring system placed this resident and
other residents at risk that their treatment would not be provided
as ordered by their physicians and implemented in their care plans.
The absence of such system goes beyond the treatment of a single
resident. The potential for a negative outcome to the health and
safety of the residents of Petitioner due to failure to provided
necessary treatment cannot be seriously disputed. Such an outcome
is contrary to the tenets of OBRA '87 and its implementing
regulations.
2. Resident 8
Resident 8's plan of care indicated that he was at risk for fluid
volume deficit. P. Ex. 25 at 5. His care plan stated (in the
column titled "Measurable and Time Oriented Objectives") that he
will have moist oral mucosa and his fluid intake will be at least
[emphasis added] 1700 cc's of fluid over a 24-hour period. Id.
The resident had been diagnosed with recent pneumonia and current
stage 3 decubitus (pressure sores). HCFA Ex. 2 at 12. The care
plan approaches to achieving the goal of 1700 cc's of fluid was to
"encourage fluids" and monitor the resident's intake and output.
Also, Petitioner's staff was to "[a]ssess for dry oral mucosa &
notify MD immediately if present. Monitor labs as ordered." 88/
P. Ex. 25 at 5. A surveyor's review of the resident's intake
records from December 2 to December 19, 1993 indicated that the
resident's intake was 1700 cc's on two days out of this two-week
period. 89/ HCFA Ex. 2 at 12.
HCFA argues that
. . . Petitioner's continuing failure to follow its care plan
for the resident's fluid intake when the amount of fluid being
consumed continued to fall far below the established goal, or to
change the plan if necessary, demonstrates a lack of concern and
attention to the resident's physical well-being, clearly in
contravention of OBRA and its regulations. HCFA Br. at 37.
In response, Petitioner argues that the HCFA 2567 implies that
there was a failure to follow the requirements of a plan of care
for 1700 ccs of fluid intake. Petitioner contends that "[t]he care
plan document itself does not show any such requirement but shows
this to be a goal or objective." P. Br. at 93. Further,
Petitioner asserts:
[t]he intake and output records indisputably show that the
care plan was followed with respect to the monitoring requirement
of the care plan. HCFA failed to put on any proof that the
facility did not encourage the fluids as required by the care plan.
There is accordingly no evidence indicating a failure to follow the
care plan which, contrary to the evidence, did not require that
1700 ccs be achieved in a 24-hour period.
P. Br. at 92.
Petitioner takes exception also to the statement in the HCFA 2567
alleging "[l]icensed nurse's notes did not address failure to meet
this resident's fluid needs, and in fact stated there was no
problem." Petitioner argues that "the allegation that the nurses'
notes did not reflect the failure to take in 1700 ccs of fluid is
not a violation of the regulation, which requires that care be
given in accordance with the written plan of care." P. Br. at 92.
I cannot accept Petitioner's interpretation of this resident's care
plan regarding the intake of 1700 ccs of fluid daily. The plain
meaning of the care plan -- "fluid intake will be at least 1700
cc/24 hr" -- leaves no doubt that 1700 ccs was the minimum amount
of fluid that this resident was to be provided within a 24-hour
period. The language is clearly mandatory and not permissive.
Even if the 1700 cc amount can be characterized as a goal, the care
plan makes clear that this objective was to be met each day.
The record is unambiguous as to Petitioner's failure to have this
resident meet this 1700 cc objective on a daily basis as called for
in the care plan. During the period of December 2 through December
19, 1993, the resident met the objective only on December 2 and 17,
1993. P. Ex. 25 at 2-4. Although the resident met the objective
only once during the period of December 2-8, 1993, there is no
notation on his Intake and Outpatient Record that any evaluation of
the resident or monitoring of his intake was conducted. Id. at 2.
Records for December 9-19, 1993 reflect that the resident met the
objective only once and his average 24-hour intake was 1182 ccs for
12/9 - 12/12/93 and 1278 cc's for 12/13 - 12/19/93. Id. at 3-4.
These records indicate that Petitioner's staff encouraged the
resident to increase his fluid intake and praised him for his
efforts. Id. His mucous membrane was noted to be moist. Id.
Ms. Patience testified that "it's a deficient practice if the goal
is to be 1700 cc's and they weren't meeting it, that's a deficient
practice." She stated also that the goals should have been either
updated or reassessed and the care plan should have been revised.
Tr. 2590-2591.
I conclude that Petitioner failed to treat resident 8 in accordance
with his written plan of care and thereby violated 42 C.F.R.
483.20(d)(3)(ii). Resident 8's care plan specifically provided
that he should have at least 1700 cc's of fluid over a 24-hour
period. The evidence shows that the resident did not receive the
1700 cc's of fluid except for two days out of the 18-day period
covered in the record.
Petitioner's argument that "there was no adverse impact to the
patient's state of hydration or his health, and the amount actually
consumed was adequate for his condition" is flawed. P. Resp. Br.
at 91. I have no information on this resident's status for the
first week since Petitioner's staff failed to complete its own
evaluation form. P. Ex. 25 at 2. I would agree that, if a
measuring criteria for lack of hydration is a dry oral mucosa as
suggested by the care plan, there is no evidence that this occurred
during the period December 9 - 19, 1993. 90/ Id. at 3-4. However,
I find credible the testimony of Ms. Cox and Ms. Patience that
reduction of this resident's fluid intake below the care plan
objective could have placed him at risk for pneumonia and skin
breakdown. Tr. 1078, 2588-2589. While the resident may have had
a moist mucosa, continued repeated failure to adhere to the 1700 cc
objective eventually could have placed his health and safety at
risk.
I do concur with Petitioner's position that its staff monitored the
resident's fluid intake and output. P. Br. at 92. The Intake and
Output Records in evidence support this view. P. Ex. 25 at 2-4.
But monitoring is not enough. The care plan indicated that the
resident was to receive at least 1700 cc's of fluid each day.
Petitioner did not ensure that this mandated objective in the care
plan was met. Nor did Petitioner's staff's use of encouragement
meet this requirement. Id. I do not accept Petitioner's reasoning
that monitoring this resident's fluid intake and output and
encouraging his increase intake can be substituted for following
the specific intake objective contained in the plan of care.
I agree with HCFA's contention that Petitioner was required to take
action and reassess the resident where the stated fluid intake
objective in the care plan was not achieved except for two isolated
days. HCFA Resp. Br. at 37. Notification of the physician would
be necessary even when no specific adverse impact on the resident
was noted, such as a dry mucosa. I must assume that the physician
chose the 1700 cc intake objective for some medically justifiable
reason. By not giving the resident the stated amount on a regular
basis, Petitioner was in effect altering the specific intake
objective in the care plan. Considering the potential for adverse
consequences resulting from lack of fluids, Petitioner would need
to advise the physician of the lower fluid intake and inquire
whether the care plan needed to be amended to correspond to the
fluid level that the resident was consuming. Despite the fact that
Petitioner failed to change the resident's care plan in this case,
such failure cannot be a basis for a deficiency, since it is
outside of the parameters of the cited regulation. 91/
L. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 309 (HCFA Ex. 2 at 13-14):
42 C.F.R. 483.25. Each resident must receive and the facility
must provide the necessary care and services to attain or maintain
the highest practicable physical, mental, and psychosocial
well-being, in accordance with the comprehensive assessment and
plan of care.
*****
Based on record review, observation, and interview the
facility failed to provide the necessary care and services to
attain or maintain the highest practicable physical, mental and
psychosocial well being of each resident.
Findings include:
Resident 20 was observed eating lunch in his room, in bed. He
was attempting to feed himself. Each time he lifted a spoon full
of food to his mouth he tipped the spoon, dropping most of the food
onto his lap or back onto the plate. Review of the medical record
revealed that he has a diagnosis of a stroke with hemiparesis and
diabetes. The nursing assessment indicates that he leaves 25% or
more of his food and requires supervision while eating. He is
below his ideal body weight. This resident was not properly
supervised and assessment for the use of assistive devices was
inadequate.
Review of resident 16's medical record revealed that she was
making good progress in her ability to ambulate in June 1993, as
documented by Physical Therapy staff. She was referred to the
restorative nurse aide program for continued ambulation. She was
discontinued from the program for no stated reason and currently is
on no routine ambulation program. Observation of this resident
throughout the survey revealed that she spends most of her day
restrained with a vest in a wheelchair.
Cross reference F292.
1. Resident 20
Resident 20 was admitted to the facility on March 30, 1993. P. Ex.
26 at 1. An April 1, 1993 entry in Resident 20's care plan, in the
column titled "Patient Problems/Needs" states "Alteration in
nutritional needs due to: Dx: DM [diabetes mellitus], CVA
[cerebralvascular accident] c Rt. hemiparesis, low wt. c wt. loss"
and notes that his ideal body weight range is 133 to 163 pounds.
Tr. 229-231; P. Ex. 26 at 10. Resident 20's weight upon admission
was 108.4 pounds, well below his ideal weight. P. Ex. 26 at 10.
The record indicates that Resident 20 also had Parkinson's disease
and difficulty in swallowing (dysphagia). 92/ P. Ex. 26 at 1, 10.
It is apparent from the record that all of this information was
known to Petitioner when it admitted Resident 20. Id.
Resident 20 continued to lose weight during his stay. P. Ex. 26.
HCFA contends that resident 20 was attempting to feed himself and
was unable to manage the eating utensil, dropping the food onto his
lap or onto the plate. HCFA Br. at 59. HCFA contends further that
"the resident was not properly supervised and assessment for the
use of assistive eating devices was inadequate." HCFA Br. at 60.
HCFA argues that Petitioner failed to provide resident 20 with the
necessary care and services such that he could maintain adequate
feeding. HCFA Br. at 63.
Ms. Shekell testified that from December 16, 1993 through December
31, 1993, resident 20 was assessed by Petitioner as being able to
eat independently. Tr. 232; P. Ex. 26 at 13. However, out of the
total of 48 meals that were received by resident 20 during this
time period, he consumed 75 percent or less on 34 occasions out of
the 48. P. Ex. 26 at 13; see Tr. 232-233. Moreover, Ms. Shekell
stated that, according to the minimum data set dated 4/12/93, it
appears that resident 20 was initially assessed as a "4" (total
dependence) in the "Eating" subsection of section E, but the "4"
was subsequently crossed out and replaced with a "0", indicating
that he was independent. Tr. 233-234; see P. Ex. 26 at 5.
Quarterly reviews dated July 14 and October 12, 1993 indicate that
resident 20 was able to eat independently without help or
supervision. Tr. 234-235; P. Ex. 26 at 8. However, Ms. Shekell
testified, the assessments are at odds with other parts of resident
20's record, which indicate that he had impaired range of motion
and impaired strength in his upper extremity; was prone to
contractures; had motor, memory, and sensory deficits; had impaired
cognitive status; and also had Parkinson's disease. Tr. 235-236;
see P. Ex. 26 at 3. Ms. Shekell, after describing resident 20's
impairments, stated "and yet [resident 20] was allowed to feed
himself." Tr. 236.
Petitioner contends that resident 20 "was maintained at his highest
practicable level" because he was given a special spoon to assist
him in eating independently. P. Br. at 97; see id. at 102.
Petitioner contends that resident 20 was offered other nourishment
but frequently refused it and that he also refused to eat at all on
a number of occasions. Id. at 97, 103. Petitioner notes further
that resident 20 rejected more stringent measures, such as tube
feedings. Id. at 97, 101, 103. Accordingly, Petitioner contends
there were no other alternatives by which it could have given more
nutrition to resident 20 and, "given his abilities and his state of
willingness to take nourishment," it did maintain the resident at
his highest practicable level. Id. at 97, 103.
Contrary to Petitioner's position that no other methods could have
been used to assist resident 20 with his eating, the testimony from
Ms. Shekell and Ms. Patience is that other assistive devices could
have been tried to assist resident 20 to consume larger amounts at
his meal times. Additionally, HCFA avers that Petitioner's staff
could have encouraged resident 20 in his efforts. HCFA Br. at 64.
While there is some evidence that resident 20 was offered
additional nourishment, the record as a whole reflects that
resident 20 was attempting to eat his meals independently, but was
unable to do so and was unable to consume sufficient nourishment
with the assistance that was being provided by Petitioner. P. Ex.
26; Tr. 233-236. There is no evidence that resident 20 was ever
reassessed or that his care plan was adjusted in light of the
difficulties he was having in consuming sufficient nourishment. P.
Ex. 26.
Petitioner thus failed to maintain resident 20 at his highest
practicable level because it failed to address the problems he was
experiencing in consuming sufficient nourishment. It would be one
thing if Petitioner had tried additional methods and none of these
worked. However, the only methods attempted by Petitioner to
assist resident 20 were providing him with a special spoon and
offering him additional nourishment. The record reflects that both
of these methods were ineffective, as resident 20 was observed as
not being able to eat independently and was not amenable to
accepting the additional nourishment offered by Petitioner. The
uncontradicted testimony is that other methods could have been
attempted to assist him, but were not. My finding is not that,
when a facility encounters a resident who has difficulty eating
independently, the facility must exhaustively attempt every
conceivable method to get the resident to eat. The facts are that
resident 20 was having a large amount of difficulty in consuming
sufficient nourishment to maintain his health. The record reflects
that Petitioner's approach to solving resident 20's difficulty in
eating adequately was to provide him with a special spoon and that
this was not working, as the surveyor observed. Also, the chart
reflects that he dropped much of his food. It is apparent that
Petitioner could have tried other methods, short of tube feeding or
force feeding, to enable resident 20 to eat more. Petitioner
failed to do so. Accordingly, Petitioner failed to provide
resident 20 with the care necessary to maintain or attain his
highest practicable well-being, in violation of 42 C.F.R.
483.25. 93/
2. Resident 16
HCFA contends that the deficiency with respect to resident 16
"involves Petitioner's failure to maintain [her] . . . at her
highest practicable level of ambulation following her discharge
from the restorative nurse aide (RNA) program." HCFA Resp. Br. at
40-41. According to HCFA, resident 16's medical record indicates
that she was placed in the RNA program for ambulation in June 1993
and that, during June and July 1993, she made significant progress
in her ambulation. HCFA Resp. Br. at 41; see P. Ex. 27 at 13-15
(relevant part of medical record). HCFA states that, with no
documented reason, the resident was discontinued from the program
on August 9, 1993, and that the progress notes stated that staff
would continue to ambulate her. HCFA Br. at 66. HCFA contends
that, at the time of the survey, there was no evidence that the
resident was being routinely ambulated. Id. at 68; HCFA Resp. Br.
at 41-42. Further, HCFA notes that the surveyor observed that
resident 16 was restrained with a vest in a wheelchair. HCFA Br.
at 65.
Petitioner contends that, contrary to HCFA's allegations, resident
16's medical chart indicates that she was routinely ambulated
following the conclusion of the RNA program. P. Br. at 103-110.
Petitioner alleges that "[t]here is no evidence that her
ability to ambulate declined in the slightest." P. Br. at 25.
Petitioner contends further that resident 16 "was maintained at the
highest practicable physical level with respect to her ability to
ambulate." P. Br. at 104.
I find that the record supports Petitioner's position with regard
to the ambulation of resident 16. The testimony of HCFA's
witnesses on this issue is conflicting and unpersuasive. The
record reflects that resident 16 began the RNA ambulation program
on June 15, 1993, and that the initial program was for her to
ambulate with a front wheel walker 20 feet to 60 feet with the
limited assistance of two persons, as tolerated, seven times a
week. P. Ex. 27 at 13-14; Tr. 1091-1092. The record further
indicates that resident 16 was ambulating from 60 to 100 feet
during the period June 15 - June 30, 1993, and from 80 to 100 feet
during the period July 1 - July 31, 1993. P. Ex. 27 at 13, 15. On
August 9, 1993, the resident was discontinued from the program. P.
Ex. 27 at 17-18. The 8/9/93 progress notes stated "D/C from RNA
program . . .able to ambulate 70 ft. this distance can tolerate.
Resident made progress toward the program. CNA [certified nurse's
assistant] will cont. to ambulate the resident during care." P.
Ex. 27 at 18.
On cross-examination, Petitioner's counsel questioned the surveyor
regarding certain nurse assistant records (P. Ex. 1 at 14-17) in
resident 16's chart. Upon examining these records, the surveyor,
who had previously testified that there was no evidence in the
chart that resident 16's ambulation continued following the
conclusion of the RNA program, conceded that they indicated that
resident 16 was ambulated daily throughout November and December
1993. Tr. 1517-1523. Specifically, the November 1993 nurse
assistant records contain notations which indicate that resident 16
was ambulated daily, with assistance or a walker. P. Ex. 1 at
14-15. On two occasions, resident 16 ambulated independently. P.
Ex. 1 at 15. The December 1993 nurse assistant records also show
that resident 16 ambulated daily, either with assistance or a
walker. P. Ex. 1 at 16-17. 94/
Absent HCFA establishing that Petitioner's records on this issue
were either erroneous or altered in some way to reflect an activity
which did not occur, HCFA has failed to meet its burden of proof on
this deficiency concerning resident 16's ambulation. HCFA has
offered nothing to contradict the evidence in resident 16's
records. I find that, contrary to HCFA's allegations, the records
reflect that resident 16 was ambulated routinely following the
conclusion of the RNA program.
Additionally, HCFA has offered nothing more than an unsubstantiated
allegation that resident 16's ambulation declined. I realize that,
while Petitioner's records do establish that resident 16 was
ambulated, they are not illuminative regarding the actual distance
that resident 16 was ambulated. P. Exs. 1, 27. However, HCFA has
not offered anything from which I can conclude that resident 16 was
not ambulated such that she was not maintained at her highest
practicable level. Moreover, the testimony of the surveyor on this
issue was unpersuasive. When pressed on the issue of how it was
that she was aware that resident 16's ambulation had declined, the
surveyor could only speculate. Tr. 1528-1529.
HCFA argues further that resident 16's care plan did not contain
any goals regarding ambulation and that Petitioner should have
documented daily the frequency and distances of resident 16's
ambulation so that it could be assessed whether the resident was
maintaining her highest ambulation level. HCFA Resp. Br. at 41-43.
Because I find that Petitioner was not deficient with regard to
maintaining the ambulation of resident 16 at its highest
practicable level, I do not address these issues.
M. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 320 (HCFA Ex. 2 at 14-15):
42 C.F.R. 483.25(c)(2) (2) A resident having pressure sores
receives necessary treatment and services to promote healing,
prevent infection and prevent new sores from developing.
*****
Based upon observation, interview and medical record review it
was determined staff failed to provides [sic] services and
treatment to prevent development of decubitus and promote healing.
Findings include:
During observation of residents with decubitus and review of
records it was noted approximately 35 pressure sores had developed
within the facility, indicating a lack of identifying residents
prone to skin breakdown, early identification, and inadequate
treatment.
Resident 31 had an order for a Tegaderm dressing to be in
place at all times. On 12-22-93 prior to observation of a
treatment and change of dressing it was noted that the tegaderm was
not in place. Other open areas to be treated did not have
dressings in place as ordered by the physician. The treatment
sheet indicated the dressings were in place and checked for proper
placement. Residents with skin problems were noted to have poor
inadequate positioning devices to alleviate pressure to the
affected area.
Resident 31's medical record indicates that the dressing was to be
changed twice a day. The physician's order dated December 1, 1993
states "cleanse open area coccyx [with] nss [normal saline
solution], pat dry and apply Carrington gel and cover [with]
Tegaderm dressing BID [twice a day] till clean then d/c
[discontinue]." P. Ex. 28 at 17.
Ms. Patience indicated that, in this instance, the purpose of the
Tegaderm dressing was to act as a barrier to protect the wound from
outside bacteria, as well as to keep the gel in place. Tr.
2620-2621. Ms. Patience explained the consequences to a resident
if the Tegaderm were to come off:
[t]he gel might not stay in place and might leak out of the
wound. And, there also is opportunity for infection because of the
bacteria. There also could be further skin breakdown because of
any contact it may -- the wound may have with the bedding and the
bed.
Tr. 2621.
Ms. Patience stated that, in a situation like this, the physician's
order would require that the Tegaderm be in place at all times.
Tr. 2621.
Further, with regard to resident 31, Ms. Shekell testified:
I went in to watch the [staff] person change a dressing on a
resident and the resident had a physician's order for Tegaderm
which is an adhesive-type covering, dressing, to cover the area and
when I went in on 12-22 to observe this treatment and change of
dressing it was noted that the Tegaderm was not in its place.
There was [sic] additional open areas on the patient and they did
not have dressings as was ordered by the physician. I then went to
the treatment record and it indicated that the dressings were in
place and had been checked on the previous shift for proper
placement.
Tr. 241.
In response to this deficiency, Petitioner argues the following:
(1) "there was no evidence of any failure to apply the Tegaderm
dressing twice a day," which is all the physician ordered; (2)
"assuming there was a failure to comply with the physician's
order," the noncompliance was a single instance which was
immediately corrected; and (3) the resident's medical record showed
that the "pressure sore improved from a stage 3 to a stage 1." P.
Br. at 112.
Petitioner's argument that it followed the physician's order to the
letter with regard to this resident and that there was no evidence
to indicate that it did not apply the Tegaderm twice a day suggests
that Petitioner does not understand that merely following a
physician's order is not enough. One of the purposes of the
Tegaderm is to protect the Carrington gel from oozing out. Without
the Tegaderm, the resident is subject to infection from bacteria
coming into contact with the pressure sores. This resident had
more than one Tegaderm dressing missing which put her at a greater
risk for bacterial infection. Even if the medical record indicated
that the previous shift had noted that the Tegaderm dressings were
in place, Petitioner is responsible for checking on the resident's
condition to see that she was not unnecessarily put at risk by the
slippage of the Tegaderm dressing. The surveyor observed that the
dressings were not in place. The surveyor's observation regarding
the treatment of this resident's pressure sores indicates that
Petitioner's staff may not have been accurately recording in the
treatment records the application of the required treatment. Here,
again, Petitioner could easily have substantiated the accuracy. I
conclude that Petitioner violated 42 C.F.R. 483.25(c)(2) with
respect to the treatment of resident 31.
Finally, assuming arguendo that resident 31's "pressure sore
improved from a stage 3 to a stage 1" (P. Br. at 112), I have no
way of knowing if all of resident 31's pressure sores improved or
worsened, nor do I know to what extent, if any, this resident was
at risk for bacterial infection to other pressure sores. With
respect to the HCFA 2567's mention that "approximately 35 pressure
sores had developed within the facility" (HCFA Ex. 2 at 15), the
record is silent as to how many residents had pressure sores. HCFA
has failed to prove this aspect of the deficiency as set forth in
the HCFA 2567.
N. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 324 (HCFA Ex. 2 at 15-16):
42 C.F.R. 483.25(e)(2) (2) A resident with a limited range of
motion receives appropriate treatment and services to increase
range of motion and/or to prevent further decrease in range of
motion.
*****
Based on observation, interview and record review it was
determined that staff failed to provide appropriate treatment to
increase and/or prevent further decrease in range of motion.
Findings include:
Resident 2 was noted to have as [sic] left hand and arm splint
in place. It was noted that the splint was not properly applied to
benefit the resident and prevent further decrease in range of
motion. Other residents observed in the hallway were observed to
have adaptive devices which were not placed properly to provide
therapeutic treatment.
HCFA admits, in effect, that the surveyor mistakenly designated
resident 2 as the subject. HCFA Br. at 72. However, HCFA proposes
that "based on other findings already discussed at length herein,
such as the failure to properly position the gentleman found
sitting in the Linard seating system, and the failure to apply the
E-Z boot as ordered for the resident who suffered from foot drop,
it is submitted that this deficiency has been amply supported by
the record, and that adaptive devices were often not placed
properly, or even at all, to provide the therapeutic treatment for
which they were intended." Id.
There was no oral or documentary evidence presented on this alleged
deficiency. Since the HCFA 2567 incorrectly identifies resident 2
as the subject of this deficiency, I find that HCFA has not met its
burden of proof here. I must agree with Petitioner that, absent
the designation of a specific resident as the subject of this
deficiency, I do not have a sufficient basis to conclude that
"other residents" were subject also to adaptive devices which were
improperly placed. It is not enough for HCFA to offer examples of
residents who were discussed in other deficiencies to corroborate
the allegations in this deficiency. I might consider evidence of
other deficiencies if the deficiency in question had cross
references (see HCFA Ex. 2 at 5, 6, 9, 10-11, 14 for citations to
deficiencies which cross reference other deficiencies in the HCFA
2567), but there are no cross references cited here. To conclude
that I can look to other evidence to support this deficiency would
be violative of Petitioner's due process rights since HCFA never
identified the resident who is the subject of the deficiency.
Thus, Petitioner had no opportunity to defend against this alleged
deficiency.
I conclude that HCFA failed to prove that Petitioner was in
violation of 42 C.F.R. 483.25(e)(2).
O. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 373 (HCFA Ex. 2 at 16-17):
42 C.F.R. 483.35(f)(3) (3) The facility must offer snacks at
bedtime daily.
*****
Based on interview of residents and staff, the facility failed
to offer snacks at bedtime daily.
Findings include:
Two of four residents interviewed by this evaluator stated
that they were [not] 95/ offered snacks at bedtime. Both stated
that they would like to have snacks. Licensed staff interviewed on
one station stated that residents only get snacks if they have a
physician's order, or if they request it. Resident[s] are not
offered snacks on a routine basis. The medical record of one
resident documents no snacks were given, while the other has only
intermittent snacks documented.
HCFA relies on the testimony of Ms. Cox for proof of this
deficiency:
I interviewed four residents, and two of the residents stated
to me when I asked them about dietary problems or about their
meals, . . . that they were not offered snacks at bedtime. . . .
[T]hey both stated that they would like to have snacks and they
were not getting them, and I talked to the licensed nurse at the
station and she said that the residents only get snacks if they
have a specific physician's order or if they request it daily[.] .
. . [T]he resident[s] should not have to request [snacks] daily
because the regulation reads that they must be offered snacks at
bedtime daily, and they [i.e. the residents] were deemed
interviewable by the facility itself, and so when you're
interviewing interviewable residents that the facility says, yes,
you know, they understand what you're going to say to them; they
participate in their daily care, then I have to take their word for
the fact that they were not offered snacks daily and that they
would like to have . . . [them].
Tr. 1103.
Petitioner makes several arguments in response to the cited
deficiency. First, the two residents surveyed who indicated a
failure to receive bedtime snacks represented an isolated
circumstance -- two residents out of a resident population of 234.
P. Br. at 121. Second, Petitioner had a policy of offering snacks
at bedtime and forms existed in each resident's record which could
verify that they were offered such snacks. Id. at 122. Third, Ms.
Cox testified that she never consulted these resident records in
preparing the deficiency. Id. at 123. And last, because Ms. Cox
could not identify the residents who she interviewed for this
deficiency, Ms. Downing reviewed resident records for all of the
identified residents who were listed on the survey team's
resident roster (P. Ex. 50) and determined that all residents
except for those on tube feeding were offered snacks at bedtime.
Id. 123-124.
Ms. Cox had no recollection of the identities of the two residents,
although she did examine their resident records which reflected no
snacks given to one resident and only intermittent snacks given to
the other. Tr. 1366, 1368-1371. However, inasmuch as Ms. Cox
could not identify the residents, I find her statement regarding
review of their resident records to be without probative value.
I did review P. Ex. 30 which, according to Ms. Downing, is a
compilation of the December 1993 monthly flow sheets for all the
residents listed on the sample resident roster used by the
surveyors in selecting residents for interviews. Tr. 2039.
However, I did not reach the same conclusion as Ms. Downing that
all residents except for those on tube feedings were offered snacks
at bedtime. I do agree with HCFA's counsel's observation that the
notations on the monthly flow sheets contained in P. Ex. 30 are at
times inconsistent and confusing. 96/ HCFA Resp. Br. at 46. In
the applicable block for "HS nourishment offered" 97/, some blocks
have checks (P. Ex. 30 at 1-2, 5-6, 8-10, 12, 19-20, 32-34, 45-49,
55-56, 58, 69, 71-72); some have "y" marks (id. at 3-4, 24, 65-66,
70); some have "no" (id. at 10) 98/; some have "NA" 99/
(id. at 11
100/, 14-15 101/, 16 102/, 22 103/, 23 104/, 28 105/, 37-38 106/,
40-41 107/, 60 108/, 62 109/); some have the letter "N" 110/ (id.
at 11 111/, 18 112/, 21 113/, 23 114/, 25-26 115/); some have
dashes 116/ (id. at 16 117/, 57 118/); some have numerical markings
(id. at 29 119/, 35-36); some have a variety of notations on the
same page (id. at 7, 11, 16, 21, 23, 28-29, 36, 50, 53 120/ 59);
and some have "gt" 121/ (id. at 43-44, 51-54, 67-68). Ms. Downing
explained that a check mark or "y", which means yes, indicates that
snacks were offered to the residents. Tr. 2047. She further
testified that a dash means that the snack was not accepted. But
when I inquired how she knows that the dash does not mean that the
snack wasn't offered, she said it would be documented on back of
the applicable flow sheet page. She admitted that the backs of the
flow sheets were not copied. Tr. 2052-2053.
My review of these flow sheets, particularly those with dashes,
"NA", "N", and "no", supports a finding that a
number of these
residents were not offered bedtime snacks and were not on special
diets which would have precluded such food. I do find Ms.
Downing's explanation of the meaning of a dash, and, arguably,
similar meanings for "N", and "no", to be lacking in credibility.
Petitioner assembled this exhibit and, if there was exculpatory
information on the back pages of the resident records, I would
expect such documents to be offered in evidence as well. None were
provided. The regulation requires the provision of snacks at
bedtime. If they were offered to and rejected by the resident, it
was incumbent on Petitioner to document this occurrence. Absent
records, which are clearly the "best evidence" demonstrating such
rejection, I conclude that the bedtime snacks were neither offered
or provided.
Other records support that Petitioner did provide special snacks to
residents who requested something different from the routine
snacks. Tr. 2039-2040; P. Ex. 30 at 73-93. But I read 42 C.F.R.
483.35(f)(3) to require the facility to offer bedtime snacks to all
residents unless it is medically contraindicated. This Petitioner
did not do.
Petitioner introduced a document which it contends reflects that it
had a policy in place that "all residents will be offered a bed
time snack to the extent medically possible." P. Ex. 30 at 94-95.
Interestingly, the document indicates that it was revised "12/93."
Id. at 94. Questioning Ms. Cox, Petitioner's counsel suggested
that the snack policy was revised prior to the end of the survey.
Tr. 1372. Ms. Cox responded that she had no knowledge of such
change in policy. Id. Ms. Cox did testify that the supervisory or
charge licensed nurse who indicated that the policy was not to
provide snacks to residents unless mandated by their physicians or
by a specific resident's requests was responsible for an entire
nursing station servicing approximately 60 residents. Tr. 1381.
She interpreted the statement of the charge nurse concerning the
availability of snacks as representing the "routine of the
facility." Tr. 1378.
Ms. Downing testified that the policy was revised in December 1993,
and while she had no knowledge of the exact date of the change, she
stated that she was advised by the Director of Nursing at that
time, Christina Tang, that it occurred "before the survey." Tr.
2040-2041. She testified further that she was not aware of any
policy that said that snacks would be offered only upon a
physician's order. Tr. 2041.
Petitioner presented no testimony from anyone on its nursing staff
who was present at the time of the survey to contradict Ms. Cox's
survey findings relating to this deficiency. Contrary to
Petitioner's assertion that a revised policy existed at the time of
the survey which ensured that residents would be offered snacks at
bedtime, there is no explanation of the admission of its charge
nurse made during the survey which indicated a bedtime snack policy
different from the revised policy. Moreover, I am dubious of the
validity of the assertion by Ms. Downing that the revision occurred
before the survey when the snack issue was raised at the time of
the survey 122/. The more likely scenario is that Petitioner
revised its policy based on the finding of the State surveyor.
There is no credible evidence that the policy was revised before
the survey was completed. Such a change would have been noted by
the State surveyor with the possibility of no deficiency being
found. This did not occur. Accordingly, I cannot find that
Petitioner implemented the "Procedure for Bed Time (H.S.) Snack"
policy reflected in P. Ex. 30 at 94-95 until after the survey was
completed and the plan of correction was submitted.
As a last argument, Petitioner asserts that the evidence does not
prove that the failure to provide snacks to residents at bedtime
represented a pattern at its facility. P. Resp. Br. at 37-38. I
reject this argument. My review of P. Ex. 30 and the admission by
Petitioner's charge nurse amply demonstrate that a pattern existed
at Petitioner of violating the regulation. Moreover, it follows
that Petitioner's failure to provide snacks as required by
regulation would likely result in a diminishment of the mental and
psychosocial well-being of its residents. Such a conclusion can be
inferred from the statements of the residents interviewed by Ms.
Cox. Petitioner failed to provide bedtime snacks daily to all of
its residents, in violation of 42 C.F.R. 483.35(f)(3).
P. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 441 (HCFA Ex. 2 at 17-18):
42 C.F.R. 483.65(a)(1) (1) Investigates, controls, and
prevents infections in the facility;
*****
Based upon observation and medical record review it was
determined that staff failed to provide care to prevent infections
in the care of residents.
Findings include:
On 12/12/93 a licensed nurse was observed taking a container
of juice from the medication cart into a resident's room and
sitting it on the resident's over-bed table. This resident has a
diagnosis of Methcillin [sic] resistant staphylococcal infection
and had a sign posted above her bed that indicated that she was on
contact isolation. After the resident finished taking her
medications, the licensed nurse returned the contained [sic] of
juice to the medication cart, increasing the risk of spreading
infection.
During observation of care of residents with decubitus open
areas it was noted that sterile technique was not observed as per
the facility policy and procedure. A sterile tray used was not
kept sterile. Sterile gloves, dressings and supplies used in the
treatment were not kept sterile to prevent infection in the open
wound.
Aseptic technique was not used in the care of the wound.
With respect to the first part of the alleged deficiency,
concerning the medication nurse's handling of the juice container,
HCFA relies on the testimony of Ms. Cox and Ms. Patience.
Specifically, Ms. Cox stated at the hearing that she observed a
medication nurse taking a juice container from the medication cart
into the room of a resident that had a documented infection and
placing the container on the resident's over-bed table. After the
nurse poured the juice into the resident's glass, the nurse
returned the contaminated juice container to the top of the
medication cart. Tr. 1105. Ms. Cox testified that the nurse's
action "[was] just not an acceptable standard to follow to prevent
infections." Id.; HCFA Br. at 74. Ms. Cox testified further that
"a common container used for every patient" should never be taken
into the room of a resident with an infection and subsequently
returned to a piece of equipment "used by the general population."
Tr. 1105-1106; HCFA Br. at 74-75.
In addition, Ms. Patience testified:
If the resident is supposed to be kept on contact isolation,
that means that things are not supposed to be leaving that room
that have come in contact with surfaces or the resident. And, the
fact that the juice container touched the over-bed table and then
was taken out, broke that contact isolation.
Tr. 2626.
HCFA states that the resident's infection could have been
transmitted on the juice container. Finally, HCFA asserts that,
notwithstanding the particular nature of the resident's infection,
the action of the medication nurse showed that appropriate
precautions were not being taken to prevent the spread of infection
to other residents. HCFA Br. at 75.
In response to the first part of the cited deficiency, Petitioner
states that HCFA's claim does not comport with the facts.
Specifically, Petitioner asserts that the sole occasion where a
nurse put a container of juice on the over-bed table of a resident
involved a resident who was not isolated but was on "contact
isolation." In addition, the infection-spreading characteristics
of "non-colonized" residents with methicillin resistant
staphylococcal aureaus ("MRSA") differ from those of "colonized"
MRSA individuals, and the HCFA witnesses lacked knowledge of the
nature of the condition and were unable to state whether the
resident in question was colonized. P. Br. at 139-144.
Petitioner further posits that the single act of placing the
container on the resident's over-bed table did not risk spreading
infection because the container was a vector, and the resident's
infection could not have been transmitted by a vector. Rather, the
infection could have been carried only through contact with moist
secretions, of which there was no evidence. Finally, Petitioner
stated that if there was a deficiency, it was corrected prior to
the conclusion of the survey and therefore should not have been in
the HCFA 2567. P. Br. at 140-141.
The essence of the first part of the alleged deficiency is that the
medication nurse's acts of placing a juice container from the
medication cart onto the over-bed table of a resident on contact
isolation with MRSA, and then returning the container to the
medication cart, risked transmitting infection to other residents.
Most notably, I find the cornerstone of HCFA's proof, the testimony
of Ms. Cox concerning her observation of the medication nurse's
specific actions, both persuasive and uncontradicted. Similarly,
I note that Petitioner did not specifically challenge the testimony
of Ms. Cox that the nurse's actions were inconsistent with standard
protocol. Rather, in response to the allegations in this part of
the deficiency, Petitioner submits that the facts relating to the
nature of the resident infection at issue reveal that the infection
could not have been transmitted by the juice container alone. P.
Br. at 140-141.
Notwithstanding its challenges, however, Petitioner indicated that,
whether or not the resident was colonized, if any secretions had
been transmitted to the container when it was brought into the room
and subsequently returned to the medication cart, then the
transmission of infection could have occurred. P. Br. at 140.
Petitioner nevertheless submits that the deficiency lacks
foundation because the HCFA witnesses were unable to present any
evidence that moist secretions were present at the time of the
observed actions. P. Resp. Br. at 39.
I find this aspect of Petitioner's argument, however, to be
inapposite. That is, the issue at hand is not whether moist
secretions were actually present, or whether the transmission of
infection actually occurred. Rather, the deficiency relates to
whether the employee's actions could have increased the risk of
infection spreading because the container could have come in
contact with moist secretions when it was brought into the room of
a resident on contact isolation, placed on that resident's over-bed
table and subsequently returned to the medication cart.
Therefore, based on the testimony, strengthened by Petitioner's
acknowledgment that the infection of the resident on contact
isolation could have been transmitted by contact with moist
secretions, I conclude that the record supports the existence of
the cited deficiency. Further, while the actions which were the
subject of the first part of the findings represent a single
incident, I find that the gravity of the breach in acceptable
protocol to be a substantial action supporting the deficiency. 123/
Accordingly, because the observed actions of the medication nurse
could have increased the possibility of transmission of infection,
I find that the first part of the cited deficiency represents a
failure by Petitioner to control and prevent infections as required
by 42 C.F.R. 483.65(a)(1).
With respect to the second part of the alleged deficiency,
concerning whether sterile and/or aseptic technique was used in the
care of residents with decubitus open areas, HCFA relies on the
testimony of Ms. Shekell:
in getting the materials necessary to dress that open wound
correctly good technique was not used in cleansing and applying the
dressing as it should be. In other words, the -- staff person, was
a licensed person, contaminated the area during the process of
changing that dressing.
Tr. 256.
HCFA relies also on the statement of Ms. Patience that "neither
sterile nor aseptic technique was used in caring for [an] open
wound. So that the resident was left open to a greater risk of
infection." Tr. 2627-2628, 2636; HCFA Br. at 76-77.
In response to the second part of the alleged deficiency,
Petitioner avers that it was denied due process because it was not
afforded adequate notice of the identities of all but one of the
residents that were the subject of the deficiency to confirm or
deny the allegations and to defend itself against them. Petitioner
further asserts that, while Ms. Shekell initially testified that
the deficiency related to resident 31, she later was uncertain
whether the alleged deficiency in fact related to that resident.
Petitioner stated also that there was a failure of proof with
respect to the deficiency as it would relate to resident 31. Tr.
256, 756, 760-766; P. Br. at 127-132.
In addition, Petitioner states that Ms. Shekell later testified
that a number of other residents were the subject of the
deficiency, but she could identify neither the residents
themselves, nor the staff who could provide the names of the
residents. Further, while Ms. Shekell stated that the identities
of the residents could be ascertained from her notes, those notes
had been suppressed pursuant to my prior order. Petitioner argues
that HCFA's failure to identify the residents involved in the
deficiency not only denied Petitioner due process, but also
constitutes a complete failure of proof on the issue. Finally,
Petitioner contends that the deficiency is defective because it is
unclear whether HCFA's allegations relate to non-sterile or
non-aseptic conditions. Tr. 616-618, 633; P. Br. at 133-138.
With regard to the second part of the alleged deficiency, I find,
as a preliminary matter, that the statement as written in the HCFA
2567 is vague and confusing. That is, while the first sentence in
the statement speaks of "residents" in the plural, and the failure
to use "sterile technique" as required by Petitioner's policy, the
last two sentences of the statement refer only to a single "wound"
and a failure to use "aseptic technique." Thus, the document did
not make clear whether this part of the alleged deficiency related
to the observation of the treatment of one resident or more than
one resident, and whether the deficiency related to the failure to
follow sterile technique, aseptic technique, or both.
While HCFA was provided ample opportunity to submit testimony and
documentary evidence to clarify and support this part of the
alleged deficiency, it instead relied predominantly on the
testimony of Ms. Shekell at the hearing. In her testimony, Ms.
Shekell stated that resident 31 was one of the subjects of the
alleged deficiency. Tr. 614-616, 751. Initially, Ms. Shekell
testified that this resident's wound was open, at risk of
infection, and was not dressed correctly. Tr. 256. On
cross-examination, however, Ms. Shekell was unable to testify as to
whether a sterile tray, sterile gloves, or supplies were used with
respect to the identified resident, and she could not state the
specific manner in which the dressing used for the resident was not
kept sterile. Tr. 757-766. In addition, on cross-examination it
was revealed that the resident did not have an open decubitus wound
at the time of the survey. Tr. 772.
Further, while Ms. Shekell testified that other residents were also
the subject of the deficiency, she could neither identify those
residents nor identify the staff nurse who accompanied her during
the survey who would know the identities of the residents. Tr.
614-616, 620, 632, 751-52. While Ms. Shekell indicated that her
survey notes reflected which residents were seen with respect to
the deficiency, those notes were not available because they had
been suppressed prior to the hearing. Tr. 639.
As I stated at the beginning of this decision, HCFA had earlier
moved to suppress the surveyors' notes in their entirety on the
basis of the deliberative process privilege, and, in December 1994,
I ruled in favor of HCFA. It is important to note, however, that
HCFA instead could have moved to sanitize the surveyors' notes by
redacting information related to the deliberative process privilege
and preserving the factual information contained in the notes for
use in the proceedings. HCFA, nevertheless, chose not to pursue
this opportunity, and it therefore could not use the factual
elements of the notes to support the witness' testimony concerning
the second part of the alleged deficiency. 124/
As an apparent consequence of the lack of documentation
available at the hearing, Ms. Shekell's testimony as a whole
emerged confused and contradictory. Further, without her notes,
the witness was unable to describe in sufficient detail the facts
underlying the stated deficiency as they related to the residents
who were observed, the particular nature of the wounds that were
treated, or the precise manner in which the residents' wounds were
treated. Moreover, HCFA failed to provide any other testimony or
documentation concerning the residents and the staff actions
observed in connection with the second part of the deficiency.
Absent this necessary information, it is impossible to determine
what specific policies and procedures Petitioner was required to
follow, and did or did not follow, with respect to sterile and/or
aseptic treatment of resident wounds.
Accordingly, I conclude that HCFA failed to meet its burden of
proof with respect to the allegations contained in the second part
of the deficiency. Specifically, the imprecise statement in the
HCFA 2567, together with the vague and at times inconsistent
testimony presented, failed to establish the existence of facts
showing that Petitioner failed to use sterile and/or aseptic
technique when required. Thus, with respect to the second part of
the alleged deficiency, HCFA did not meet its burden of proving the
elements which justify its determination that sterile and/or
aseptic technique was not followed when required to control and
prevent infection as required by 42 C.F.R. 483.65(a)(1).
Q. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 443 (HCFA Ex. 2 at 18):
42 C.F.R. 483.65(a)(3) (3) Maintains a record of incidents
and corrective actions related to infections.
*****
On the HCFA 2567, no basis or findings were set forth for this
alleged deficiency. HCFA Ex. 2 at 18.
At the hearing, Ms. Shekell admitted that this citation had been
inadvertently keyed into the computer. Tr. 257. Accordingly,
because this alleged deficiency was cited in error, I find that
there is no deficiency here. F 443 has no bearing for purposes of
this decision
R. Set out below, in relevant part, is the statement in the HCFA
2567 concerning the alleged deficiency identified as F 462 (HCFA
Ex. 2 at 18-24): 125/
42 C.F.R. 483.70(d)(1) (ii) Measure at least 80 square feet
per resident in multiple resident bedrooms, and at least 100 square
feet in single resident rooms;
*****
Based on observation and record review the facility failed to
provide at least 80 square feet per resident in 2/3 of the multiple
resident bedrooms.
*****
Neither HCFA nor Petitioner offered any proof relating to F 462 at
the hearing or in their briefs. Accordingly, as there is nothing
in the record, I find that HCFA has failed to prove the existence
of this deficiency.
S. Set out below is the statement in the HCFA 2567 concerning the
alleged deficiency identified as F 527 (HCFA Ex. 2 at 25): 126/
42 C.F.R. 483.75(l)(1) (1) The facility must maintain
clinical records on each resident in accordance with accepted
professional standards and practices that are -- (i) Complete; (ii)
Accurately documented; (iii) Readily accessible; and (iv)
Systematically organized.
*****
Petitioner submitted P. Ex. 32 as being the relevant resident
record with respect to F 527. At the hearing, however, HCFA did
not present any testimony addressing this alleged deficiency 127/,
and Petitioner did not present any testimony with respect to P. Ex.
32. Neither HCFA nor Petitioner addressed F 527 in its briefs.
Accordingly, I find that HCFA has failed to prove this deficiency.
Conclusion
Petitioner takes issue with HCFA's determination that the date of
its certification as a Medicare provider of skilled nursing
services was effective on January 31, 1994. This date was based on
Petitioner's submittal of an acceptable Plan of Correction for
deficiencies contained in the HCFA 2567 which was prepared in
connection with an initial survey of Petitioner
during the period of December 14 - 23, 1993. Pursuant to 42 C.F.R.
489.13, the effective date of Petitioner's certification is the
earliest date when there is correction of the deficiencies found in
the survey or submission of an acceptable plan of correction.
Under this regulation, even one deficiency could be the basis for
a delay in the effective date of certification. The record
supports that deficiencies of 42 C.F.R. 483 et. seq. were
present during the survey of Petitioner, were not corrected at
completion of the survey, and were the subject of an acceptable
plan of correction submitted on January 31, 1994. Accordingly, I
affirm HCFA's determination that Petitioner's certification as a
Medicare provider was effective on January 31, 1994.
Edward D. Steinman
Administrative Law Judge
1. HCFA subsequently issued an amended letter dated February
28, 1994, to Petitioner. The only change from the earlier letter
dated February 23, 1994, is that a different fiscal intermediary is
named. HCFA Ex. 6.
HCFA submitted HCFA Exs. 1-15. Petitioner submitted Petitioner's
Exhibits (P. Exs.) 1-4, 9-10, 19-32, 34-36, 41, 43-53. At the
hearing, I admitted HCFA Exs. 1-15 and P. Exs. 1-4, 9-10, 19-32,
34-36, 41, 43-48, and 50-53 into evidence. I rejected P. Ex. 49.
Petitioner provided a list with its opening posthearing brief
stating the exhibits which were admitted in this case. Upon
examining Petitioner's list and carefully checking the record, I
have determined that Petitioner's list is inaccurate.
The parties' posthearing briefs, the transcript of the hearing, and
my findings of fact and conclusions of law will be cited as
follows:
Transcript of Hearing Tr. (page)
HCFA's Opening Posthearing HCFA Br. at (page)
Memorandum
Petitioner's Posthearing P. Br. at (page)
Brief
HCFA's Posthearing Response HCFA Resp. Br. at
(page)
Petitioner's Opposing Brief P. Resp. Br. at (page) (to
HCFA's Opening Post-Hearing
Memorandum)
HCFA's Posthearing Reply HCFA Rep. Br. at
(page)
Petitioner's Reply Brief to P. Rep. Br. at (page)
HCFA Post-Hearing Response
My Findings of Fact and FFCL (number)
Conclusions of Law
2. FFCL 1-10 are HCFA's Proposed Findings of Fact and Conclusions
of Law 1, 2, 7-8, 28-30, and 32-34, which I have adopted, in
pertinent part. Petitioner did not object to these specific
findings of fact and conclusions of law and, thus, I am adopting
them. Where necessary for purposes of clarity and consistency of
style, I have made editorial changes, which do not alter the
substance of the findings.
Although there were other proposed findings of fact and conclusions
of law submitted by HCFA to which Petitioner did not object, I have
chosen not to adopt them.
I have made my own findings of fact and conclusions of law based on
my independent review of the record, and these are set forth
beginning at FFCL 11.
3. Hereinafter, I refer to the San Diego District Office of
Licensing and Certification as "DHS-San Diego."
4. The pages cited in the parentheses refer to the pages in the
decision where these findings are discussed.
5. Petitioner was instructed to prepare a written plan of
correction to resolve the deficiencies and to describe the proposed
corrections in the right-hand columns of the HCFA 2567. The HCFA
2567 which is in evidence contains also Petitioner's plan of
correction. HCFA Ex. 2.
6. Ms. Allison testified that the investigation concluded in
November 1993 or early December 1993. Tr. 2757, 2781. Ms. Allison
stated also that DHS "took constructive action to review the
complaints to determine" if they needed to be reopened or
investigated. Tr. 2746.
7. There are two House reports which comprise the legislative
history for H.R. 3545 (OBRA '87): H.R. Rep. No. 391, 100th Cong.,
1st Sess., pts. 1 & 2 (1987), reprinted in 1987 U.S. Code Cong. &
Admin. News 2313-1; and H.R. Conf. Rep. No. 495, 100th Cong., 1st
Sess. (1987), reprinted in 1987 U.S. Code Cong. & Admin. News
2313-1245.
8. These requirements are codified at 42 U.S.C.
1395i-3(b)(2) and (3).
9. The quoted text appears in the section of the report in
which the congressional committee discusses Medicaid-certified
nursing facilities. The statutory provisions regarding the
resident assessment for Medicaid-certified nursing facilities are
found at 42 U.S.C. 1396r(b)(3). The statutory provisions
regarding the resident assessment for Medicare-certified skilled
nursing facilities are identical and are found at 42 U.S.C.
1395i-3(b)(3) of the Act. Accordingly, although the quoted text is
referring to nursing facilities participating in the Medicaid
program, I find that it is applicable to skilled nursing facilities
participating in the Medicare program.
10. The committee reference to the IOM Committee is a
reference to the Institute of Medicine (IOM) of the National
Academy of Sciences, which, at the request of HCFA, undertook "a
study of the policies and regulations governing the certification
of nursing homes participating in Medicare and Medicaid." The IOM
Committee on Nursing Home Regulation issued a comprehensive
415-page report in March 1986 titled "Improving the Quality of Care
of Nursing Homes." Id. at 452.
Although the quoted text appears in the section of the report
concerning nursing facilities under Medicaid, I find that the
concerns expressed by the committee regarding the survey process
apply equally to SNFs under Medicare.
The statutory provisions concerning the survey and certification
process for Medicaid-certified nursing facilities are found at 42
U.S.C. 1396r(g). The statutory provisions concerning the survey
and certification process for Medicare-certified skilled nursing
facilities are identical and are found at 42 U.S.C 1395i-3(g).
11. The July 1, 1987 proposed rule was titled "Medicare and
Medicaid Programs; Long Term Care Survey"." The October 16, 1987
proposed rule was titled "Conditions of Participation for Long Term
Care Facilities." The November 18, 1987 proposed rule was titled
"Survey and Certification of Health Care Facilities." HCFA
intended that the latter two sets of proposed regulations "would
revamp the long term care requirements under Medicare and Medicaid
to be a resident-oriented system capable of consistent
implementation by States." 53 Fed. Reg. 22,850.
HCFA later withdrew the November 1987 proposed rule. See 57 Fed.
Reg. 39,279 (1992) (recited as part of supplementary background
information).
12. The effective date was later changed to January 1, 1990.
See 56 Fed. Reg. 48,826 (1991).
13. Although the passage quoted above does not contain a
specific reference to the State Operations Manual, Transmittal No.
250, commonly known as SOM 250, one can infer that HCFA, by
mentioning that the guidelines and survey procedures were revised
in April 1992, is referring to this manual. SOM 250 was published
in April 1992. Testimony from the state surveyors makes evident
that they received extensive training from HCFA and were expected
to implement the survey process set forth in SOM 250 in all surveys
conducted after April 1992. See section VI. of this decision,
infra.
14. HCFA points to Estate of Smith v. Sullivan, (D. Colo. 1990)
for support of the position that Subpart C was rendered obsolete by
the passage of OBRA '87. HCFA Resp. Br. at 56. In this case, the
court ordered, effective October 1, 1990, that the "Secretary shall
be permitted on an interim basis to require the use of the new
survey forms, procedures and interpretive guidelines" and Subpart
C "shall be suspended but not repealed pending further orders of
this Court. . ." HCFA Attachment 2. (I discuss this order further
in section V. of this decision). HCFA contends that the new survey
forms, procedures and interpretive guidelines are those outlined by
SOM 250. HCFA Resp. Br. at 56. I am convinced that this district
court case demonstrates that HCFA was implementing OBRA '87 by
means other than Subpart C but based on this interim court order,
HCFA could not repeal that Subpart. Certainly, HCFA could have
dispelled any confusion about the operational validity of Subpart
C by publishing in the Federal Register a specific statement
relating to Subpart C. Unfortunately, this was never done. That
failure, however, cannot be used to validate the survey process in
Subpart C, which process HCFA was required to replace with the
implementation of OBRA '87.
15. It is noteworthy that a simple reading of the chart found
at 42 C.F.R 488.115 demonstrates an internal inconsistency, for
the regulations referenced in the chart pre-date OBRA '87, and,
thus, have been made inert by Congress and by HCFA's rule-making
activities. The referenced regulations are outdated and no longer
in existence today. Accordingly, it would be impossible to "apply"
this chart to any surveys which were conducted post-OBRA '87. A
review of the derivation table published in the Federal Register
leaves no doubt that the regulations referenced in the chart at 42
C.F.R. 488.115 were superseded by the new regulations published
in February 1989, which became effective on August 1, 1989. See 54
Fed. Reg. 5316, 5356-5358.
16. Unfortunately, Petitioner's brief is garbled on this point
and I am therefore forced to interpret the confused language. P.
Resp. Br. at 3-4.
17. I discuss resident selection methodology further in Section
IX of this decision.
18. In his decision dated August 21, 1992, the administrative
law judge had stated the issue "as being whether the Health Care
Financing Administration's (HCFA) failure to follow and apply the
survey process set forth in 42 C.F.R., Part 488, Subpart C, and the
use of unpublished survey procedures and materials as contained in
Appendix P of the State Operations Manual and the HCFA
Self-Instructional Manual, rendered the survey findings and HCFA's
January 11, 1991 certification of non-compliance invalid as a
matter of law." HCFA Attachment 3 at 2.
19. The Appeals Council in Devon Gables stated further:
The manner in which the Secretary selects to implement the
Congressional mandate in order to both effectuate the will of
Congress and comply with the Court's directives in the Smith
litigation is not subject to review by an Administrative Law Judge.
The Council can discern no authority for the Administrative Law
Judge to rule on the validity or invalidity of a regulation or
interpretive rule.
HCFA Attachment 3 at 4.
I do recognize that I do not have authority to declare a regulation
invalid. David S. Muransky, DAB CR95 (1990), aff'd DAB 1227
(1991); Hanlester Network, et al., DAB CR181 (1992); Charles J.
Barranco, DAB CR187 (1992). However, despite this admonition, in
fairness to Petitioner, I have carefully examined its position and
responded to the issues raised by Petitioner regarding the
operational effect of 42 C.F.R. Part 488, Subpart C. My analysis
as to the operational effect of Subpart C is based on the actions
taken by the Secretary in carrying out her responsibilities under
OBRA '87 and not on my own interpretation of the legality of these
regulations.
20. I discuss the operational significance of the SOM 250 in
section VI. of this Decision.
21. I am quoting this regulation as it was published in the 1992
version of the C.F.R. This regulation was subsequently amended in
the 1994 publication of the C.F.R. However, Petitioner was
surveyed in December 1993, prior to the time the 1994 changes were
in effect. Therefore, the controlling regulation on this issue is
the one that was in effect at the time of the survey, i.e., the
1992 version.
22. This section is the former codification of 42 C.F.R.
489.13.
23. The preamble went on to say that "[i]t is therefore
necessary from an administrative standpoint to continue to use the
Level A and Level B designations for all surveys until a new
enforcement system and accompanying forms and procedures are in
place." 56 Fed. Reg. 48,827-48,828. The preamble further stated
that remaining references to Level A and Level B would be removed
in the OBRA '87 enforcement regulation to be issued later. 56 Fed.
Reg. 48,828.
24. Petitioner never alleged that it had made a waiver request
nor does the record reflect that any waiver was granted. Thus,
this basis for altering the effective date is not an issue in this
proceeding. The only issues that are relevant to the determination
of the effective date in this proceeding relate either to the date
the deficiencies were corrected or the date HCFA accepted
Petitioner's plan of correction.
25. This conflicts with testimony from Mr. Murray, who says that
he picked up the HCFA 2567 from the DHS office on January 19, 1994.
Tr. 2189.
26. Petitioner appeared also to make a contradictory argument
that the OBRA '87 requirement that each survey include a "case-mix
stratified sample of residents" does not change any requirement of
Subpart C. P. Resp. Br. at 3. It is noteworthy that, with this
particular contention, Petitioner appears to concede that the
proper sampling methodology is case-mix stratified sampling, which
was what was employed by the surveyors in this case.
27. Although factual allegations regarding whether Resident 16
was properly ambulated and whether her ability to ambulate declined
as a result of Petitioner placing her in a vest restraint appear
also on the HCFA 2567 with respect to F 221, they are not relevant
to the issue of whether Petitioner adequately assessed Resident 16
for a less restrictive restraint as required by 42 C.F.R.
483.13(a) and F 221. They are relevant in assessing whether a
negative or potentially negative outcome resulted from this
deficiency. I address the factual allegations concerning resident
16's ambulation in the context of my discussion of F 309 (section
X.L. of this decision).
28. At the hearing, Ms. Shekell testified that she was the
surveyor who had written the specific allegations under this
regulation. Tr. 127.
29. In its discussion of F 272, Petitioner quotes statements
made by myself and by HCFA's counsel (Tr. 168, 164) at the hearing.
P. Br. at 37-39. Petitioner apparently means to illustrate that my
statements and those of HCFA's counsel were made in conjunction
with the testimony taken concerning F 272. However, an examination
of the transcript indicates that these statements were made in
conjunction with the testimony concerning F 289, not F 272.
30. I do not hold that HCFA must identify in its 2567 each
resident whose records were reviewed in connection with a cited
deficiency. However, the deficiency must provide sufficient
information such that Petitioner, exercising reasonable diligence,
could determine to whom the deficiency relates. Here the
deficiency failed to supply such information. Such failure could
be overcome where the evidence shows that Petitioner received
identifying information either in the course of the survey process
or through documentary evidence submitted in preparation for the
hearing. Neither of these circumstances occurred in this case with
respect to this deficiency. Moreover, HCFA's principal witness on
this deficiency could not offer any testimony or exhibits to
support the allegations relating to the other residents cited in
the deficiency.
31. Ms. Patience testified that she did not see "a psychosocial
assessment per se" in P. Ex. 3. She stated that she believed that
the term "psycho-social assessment" used in the HCFA 2567 is a
reference to section H of the MDS. Tr. 2685.
32. On the MDS document, below the title "Minimum Data Set," is
the phrase "For Nursing Facility Resident Assessment and Care
Screening (MDS)." P. Ex. 3 at 2.
33. There is evidence that the terms "comprehensive assessment"
and "MDS" are interchangeable. Ms. Shekell testified:
The minimum data set is -- that's where they get the word
comprehensive assessment because it goes through cognitive,
communicative, vision, hearing, skin care, ability of the patient
to take care of themself [sic], psychosocial well being, health
conditions, their ability for activity levels, for functioning
levels, nutritional levels, their potential for accidents, their
skin problems, et cetera. In other words, it's kind of looking at
the patient from head to toe.
Tr. 136.
Ms. Cox testified also that the MDS is the comprehensive
assessment. Tr. 1275.
34. Ms. Shekell testified that if a resident goes to the
hospital or is out of the facility for a short period of time, the
facility may still be able to refer back to the last MDS instead of
doing another MDS. Tr. at 671. However, if the resident's
hospital admission altered the patient's status, or the reason that
the resident was sent out of the facility was due to a change of
condition, then the facility would have to complete a new MDS upon
the resident's return to the facility. Tr. at 672.
35. The SOM 250 states, "Additional assessment information is
also gathered using triggered RAPS." HCFA Ex. 13 at P-100. Ms.
Shekell testified that the "identified problems must be transferred
to th[e] RAPS, and then this is the basis for forming a patient
care plan." Tr. 140. Ms. Shekell testified further that the MDS
and the RAPS have to correspond with each other and contain the
same information. Id.
36. The signatures section on the MDS indicates which staff
members participated in its completion, the particular section(s)
of the MDS each staff member completed, and the date of completion.
P. Ex. 3 at 2.
Although there is a signature of the staff person who completed
sections G & H of the MDS, the date of
completion of these sections is missing. P. Ex. 3 at 2.
Thus, I am using July 30, 1993 as the completion date
because it is the latest completion date given and is also the date
when the RN Assessment Coordinator signed the MDS.
37. I construe this section as requiring the facility to check
any of the eight specified indices of a sad or anxious mood that
occurred on any day during the last 30 days where such behavior
would significantly impact on the resident's care in the facility.
Therefore, a single expression of a suicidal thought or action
would require the facility to note such expression in the MDS.
38. According to SOM 250, an example of a "significant change"
would be "deterioration in behavior or mood, to the point where
daily problems arise or relationships have become problematic and
staff conclude that these changes in the resident's psychosocial
status are not likely to improve without staff intervention." HCFA
Ex. 13 at P-104.
39. In the progress notes, the psychologist indicated that one
of the resident's treatment goals was "stabilization of depressed
mood." P. Ex. 3 at 16-19. For September 1993, the psychologist
indicated that the resident had moderately progressed toward
achieving this goal. In October 1993, the progress notes show that
the resident's progress toward stabilizing her depressed mood was
at about the same level as in September. Id. at 17. In November
1993, the progress notes indicate that resident 12 was continuing
to make progress and was benefitting from group dynamics. Id. at
18. In December 1993, the notes state that she was concerned with
family issues but her underlying mood was of "strength and
optimism." Id. at 19.
40. Elavil is an antidepressant. Tr. 142.
41. There is a care plan dated September 1, 1993 for the
resident's unwillingness to leave her room except for dialysis and
group therapy. P. Ex. 3 at 24. The approaches/actions stated
relate to encouraging increased socialization and initiating group
and individual psychotherapy. Id. It was during the diagnostic
interview by the psychologist on September 15, 1993 that her
suicidal ideation and major depression was noted. P. Ex. 3 at 15.
42. See, P. Ex. 3 at 22.
43. In its opening brief, Petitioner argued that "[t]his is
clearly an area where nursing judgment dictates when assessments
should be modified" and stated that Ms. Patience had "conceded that
this was an area of judgment." P. Br. at 119. While the judgment
of Petitioner's staff does play a role in determining whether a
resident's change in condition is a "significant" change warranting
completion of a new MDS, HCFA has provided guidance, in the form of
the SOM 250, to facilities in exercising that judgment. As
Petitioner pointed out in its brief, Ms. Patience did testify:
Some of it is the nursing judgement [sic]; some of it is --
are the examples that are contained here in the 250s; some of it is
contained in the direction for the resident assessment protocols.
Tr. 2677-2678.
Ms. Patience went on to testify that it was her belief that
resident 12's change in condition "does fall in with some of these
parameters." Tr. 2678. Ms. Patience thus was of the opinion that
the proper exercise of nursing judgment with respect to resident 12
would take into consideration the SOM 250 and the facility's own
RAPS instructions. I agree; nursing judgment cannot exist in a
vacuum, and with respect to resident 12, the comments by the
psychologist, care plan entries, and her medication indicate that
her mood and behavior deteriorated sufficiently to constitute a
significant change in condition. See HCFA Ex. 13 at P-104.
Thus, arguably, the survey team should have cited F 287, in
addition to F 272, for this deficiency.
44. Ms. Cox testified that her findings concerning the alleged
deficiency with respect to resident 16 have to do with only bladder
incontinency. Tr. 1436.
On the MDS, continence is rated on a scale of 0 to 4, with 0
representing continence and 4 representing incontinence. P. Ex. 4
at 3.
45. The November quarterly review was dated 11/5/93 and, also,
11/11/93. P. Ex. 4 at 8. Ms. Cox stated at the hearing "The
assessment sheet is filled out for 8-12-93 and 11-11-93 which is
quarterly." Tr. 1190. However, Ms. Patience explained that,
because an LVN signed the assessment on 11/5/93, that 11/5/93 would
be considered the proper date of this assessment. Tr. 2510-2511.
Based on her reasoning, I am using 11/5/93 as the date of the
November quarterly. Based on this date, the 14-day time frame for
purposes of bladder continence status is 10/22/93 - 11/5/93. Had
I used 11/11/93 as the date of the November quarterly, the 14-day
time frame would be 10/29/93 - 11/11/93.
I examined the flow sheet notations for the time frame of 10/22/93
- 11/5/93 and concluded that, based on these notations, resident 16
evidenced continency status a significant amount of the time.
However, I also examined the flow sheet notations through 11/15/93,
which indicate also that resident 16 was mostly continent for the
first half of November.
There is also a quarterly review for the quarter ending 2/10/94
(270-day assessment). P. Ex. 4 at 7. However, because the
assessment of continence in this review would relate to the time
period of 1/27/94 - 2/10/94 (i.e., the last 14 days prior to the
quarterly review), I do not address this quarterly assessment,
since it is outside of the relevant time frame for purposes of this
decision.
46. In the bladder section of the flow sheet, there is also a
"Continent/Catheter" line. For the "day shift" during the
10/22 -
10/31/93 period, Petitioner's staff wrote in "0" for these dates on
the "Continent/Catheter" line. P. Ex. 4 at 15.
47. On the "Continent/Catheter" line on the flow sheet,
Petitioner's staff wrote in a "2" for the dates 10/22 - 10/23,
10/25 - 10/31, and a "3" for the date 10/24/93. P. Ex. 4 at 16.
48. On the "Continent/Catheter" line of the flow sheet,
Petitioner's staff wrote in, for the night shift of 10/22 -
10/31/93, a "2" for 10/22 and 10/24, a "3" for 10/23, 10/25,
10/28,
and 10/30, a "1" for 10/26, a "0" for 10/27, and a "4"
for 10/29
and 10/31. P. Ex. 4 at 17.
49. According to the legend given on the chart, "I" represents
incontinent and "C" represents continent. In the night shift
section, Petitioner's staff had written in "I's" for November 1 and
2, 1993 and "C's" for November 3, 1993 through November 15, 1993.
50. The notation forms of "C/I", "C/(number)", and "I/(number)"
do not correspond to the legend and are nowhere explained.
Although Ms. Cox did not testify specifically on these "day shift"
notations, she later
attempted to interpret similar notations elsewhere in the chart.
51. Had the quarterly review been accurately completed by
Petitioner with respect to her bladder continence status, this
would then have triggered the completion of new RAPS, which, in
turn, would have led to appropriate care-planning for the resident.
There is also an interdisciplinary team note dated 11/11/93 which
states, in part, "Discussion on whether the resident has made any
actual improvements/declines in her ADL functioning. Incontinent
of B & B." P. Ex. 4 at 10. Based on the flow sheet data, I find
that these notes do not give an accurate assessment of resident
16's bladder continence status.
52. With respect to the bladder "day shift" notations, Ms. Cox
attempted to interpret them:
"Day shift it says incontinent times three, I guess,
incontinent times three, incontinent times four, incontinent times
four, and then
the rest of the time it says continent, across the rest of the
page. So that's four days incontinent and the rest continent.
Tr. 1436-1437.
In attempting to get further clarification, I asked Ms. Cox:
And then the -- so the number after the letter would be the
number of times that they were either incontinent or continent?
THE WITNESS: Well, to me this is the number of times they're
incontinent . . .
. . . to me this is not very clear documentation, but if you
have a continent and then have a slash, and they have a two, to me
that means something a little different than -- see, if you go back
three days it says: "Continent times" whatever that is, it looks
like a nine actually. That's under the 25th day. . . . Some of
this is a little more clear than others. If you just have a "C/2"
that does not mean continent times two, to me. It could mean
continent and the slash two, or it could mean continent and perhaps
in there indicating that resident's incontinent. Thisis very --
just a very poor way -- method of charting. Tr. 1439.
With respect to the "P.M. Shift", Ms. Cox was unable to interpret
the notations. Tr. 1437-1438.
53. At the hearing, in response to my questioning, Ms. Cox
confirmed that this particular document "refers to an evaluation to
determine whether or not someone will be a candidate for bladder
training." Tr. 1431.
54. Although the page is a poor copy, the date of the entry
appears to be December 3, 1993.
55. On the MDS form itself, under section A, there is a place
to indicate the "reason for assessment". One of the six choices is
choice number 5 -- "Significant change in status."
56. A progress note dated 12/3/93 (7:30 p) contains a
reference to resident 16's continence status. P. Ex. 4 at 34. It
states on the third line what appears to be the following phrase:
"Incontinent of B/B". However, the first two letters of
"Incontinent" are lined through, which could indicate that "In"
is
being crossed out. If this is the case, then it may be that
Petitioner's staff had mistakenly written "Incontinent" when he/she
had meant to write "continent." The manner in which to interpret
this was disputed at the hearing. I find that it is unclear and
ambiguous; accordingly, I do not consider this entry in discussing
resident 16's bladder condition.
57. Ms. Cox had expressed the same confusion earlier on direct
examination when asked to give her interpretation of "a C with a
slash" :
. . . It could be that the person was continent twice, but
that doesn't answer when she was incontinent or how many times she
went totally, or it could say that she was continent but the two
were -- the three or whatever numbers there perhaps indicates that
that's the number of times she was incontinent so it could be
either way. I'm not sure what that means.
Tr. 1039; see also Tr. 1040-1042.
58. On direct examination regarding P. Ex. 4, pg. 21, Ms. Cox
did state "it's not totally clear to me, but obviously the C means
continent times three, if that speaks for itself it means she was
continent three times." Tr. 1042.
59. In the transcript, Ms. Downing stated that the period
12/1-12/15 is referenced on P. Ex. 4 at 16. However, this page is
a flow sheet for October 1993. The correct page cite is P. Ex. 4
at 20.
60. Ms. Cox testified that the regulation concerns "quarterly
[assessments] and revising as appropriate to insure accuracy." Tr.
1190.
61. Resident G.B. was admitted on February 17, 1993. P. Ex. 9
at 1.
62. The first page of the MDS, which would have
signatures and dates, was not included in the exhibit.
63. The record does not contain a care plan for this resident
that is consistent with my finding that her incontinent status
changed to continent. It is not necessary for me to have the
particular care plan that Ms. Cox may have reviewed during the
survey. The record is sufficiently clear that whatever care plan
she may have seen failed to reflect the resident's change in
continency. Her testimony is credible because it is supported by
the record as a whole.
64. The latter sentence does not appear in the regulatory
language of 42 C.F.R. 483.20(d)(1). For this reason, I am
ignoring this sentence. The sentence in question apparently is a
quotation from the SOM 250.
65. Resident 1 was admitted to the facility on February 1,
1993. P. Ex. 21 at 1.
66. Ms. Shekell explained that self-administration of
medication "means that the patient has the ability to have
medications in their room and take them as they feel that they need
them or per -- for example, if they wanted to take some cough
medicine they could take a cough medicine and have it at their
bedside and give it to them whenever they felt that they needed
it." Tr. 217.
67. There is no indication that, based on the documents
comprising resident 1's medical chart which is in evidence, the
earlier 2/11/93 doctor's order permitting resident 1 to have her
medicines at bedside was withdrawn or changed.
68. In light of HCFA's position that there should have been a
care plan in April 1993 in response to the 4/1/93 assessment that
resident 1 could no longer self-medicate, I find that the statement
in the HCFA 2567, "The facility failed to develop the approaches to
address her needs for 10 months. . ." is not accurate. HCFA Ex. 2
at 9. According to the record, the actual time frame during which
resident 1 was capable of self-medicating appears to have been from
February 11 to April 1, 1993. For the time period of April 1993 to
December 1993, Petitioner cannot be said to have failed to have a
care plan in place for resident 1 that allowed self-medication,
since, as of April 1, 1993, she was no longer a candidate for safe
self-administration of medications. The April 1993 assessment,
moreover, has no bearing on the 12/2/93 care plan.
69. Interestingly, Petitioner's own written procedures
regarding self-administration of medications state, among other
things, that "Licensed nurses will assess the safety and compliance
of self administration of medication by the resident, and document
on weekly nurses progress notes. The patient care plan will
reflect information regarding self-administration by the resident."
P. Ex. 21 at 35. Petitioner thus violated its own written
procedures, as well as 42 C.F.R. 483.20(d)(1).
70. Petitioner questioned Ms. Shekell on this medication
record.
71. Ms. Shekell testified that the medication record found at
P. Ex. 21 at 31 consisted only of the front side and was missing
the back side. She stated that, if a resident refused to take
medicine, staff "would put date and time and state that the patient
refused to take their medication for whatever reason." Tr. 426.
72. For December 1993, resident 1 was permitted also to keep
Antivert, vitamin C tablets, multi-vitamin tablets, and Premarin
vaginal cream at her bedside. P. Ex. 21 at 33. Petitioner's staff
indicated for each of these medications that the resident was to be
monitored.
73. In the Riopan Plus and Robitussin sections, there are two
instances of a circled initial recorded at the 3-11 shift for both
December 17 and December 21. P. Ex. 21 at 31. In the Sucrets
section, there is a circled initial recorded at the 3-11 shift for
December 17 and what could be a circled initial at the 3-11 shift
for December 21. Id.
Additionally, there are also two blank boxes in each of these three
medication sections, where nothing was recorded, for the 3-11 shift
on December 19 and the 11-7 shift on December 20. Ms. Shekell
referred to these blanks as representing that the nurse "didn't do
any monitoring or didn't initial that she had done that particular
task during that shift." Tr. 419-420.
74. Ms. Patience stated also that "there could also be
potential danger to other residents if she's keeping the medication
by the bedside and not handling it properly." Tr. 2548.
75. The testimony elicited from Ms. Patience with respect to F
272 is instructive:
The quarterly is just to give the facility kind of a check to
see if what they've assessed before in the minimum data set has
continued with the resident. If it hasn't then a whole new MDS
would be indicated, and that's part of what the quarterly is to
help the facility decide.
Q [Counsel for HCFA]: So by doing the quarterly review, does
that confine the facility to look only at the prior seven days?
A [Ms. Patience]: . . . For the quarterly you only look at
the prior seven days. Overall, what you've got to do is you've got
to look at the resident. If the resident is exhibiting a change
then there may be a new minimum data set indicated, and that needs
to be done if the resident's got a significant change.
Q [Counsel for HCFA]: So, for example, if a resident eight
days or ten days prior to a quarterly has a change in mood should
that warrant a change in the assessment?
A [Ms. Patience]: Depending upon how profound the change is,
yes . . . .
Tr. 2495-2496.
76. Pages 4 and 24 of P. Ex. 21 appear to be exact duplicates
of each other.
77. Resident 1's mood and behavior problems, as documented in
the Social Services notes, could be described as constituting a
"significant change" in her condition that should have resulted in
Petitioner completing a new MDS some time in November 1993, at the
latest. 42 C.F.R. 483.20(b)(4)(iv). This was not done. If
Petitioner had completed a new MDS for resident 1, such assessment
would have indicated, in the appropriate sections, the mood and
behavior problems that she had recently manifested. Furthermore,
this new MDS, may, in turn, have resulted in an entirely different
quarterly review than that which is in the record.
78. Ms. Cox stated: "When his assistive devices for
positioning were changed then his care plan was not changed to
reflect that." Tr. 1306-1307.
79. Ms. Downing testified that there was no indication that the
physician ever changed this order for resident 20's seating system.
Tr. 1916. She explained that, in long-term care settings, seating
systems are primarily used for postural support and body alignment.
Tr. 1928.
80. Ms. Cox testified that the Linard system is "a soft system
that's shaped in a semicircle that comes up high on the resident
and fastens in front to try and keep them from leaning to one side
or the other. Help them sit up straight." Tr. 1458. Ms. Downing
testified that she was familiar with the Linard seating system and
stated that it is a brand of a pre-made, postural seating system
that supports a person's upper trunk. Tr. 1914.
81. Ms. Downing began working for Petitioner on January 17,
1994. Tr. 1687-1688.
82. At the hearing, both Ms. Downing and Ms. Patience testified
as to what kind of "change" in positioning devices or seating
systems would warrant revision of the care plan. Ms. Downing
testified that a resident who was using a "seating postural
support" or any kind of restraint required periodic re-evaluation
"every two hours to make sure that. . .they're positioned right,
that the support is positioned correctly, to check their
circulation, to ensure that their posture is being maintained."
Tr. 1924. Ms. Downing stated that these periodic re-evaluations of
the resident would not necessitate changing his or her care plan.
Tr. 1924.
Ms. Patience, like Ms. Downing, had no first-hand knowledge of the
incident involving resident 20 which forms the basis of this
deficiency. She testified that the readjustment of a slipped
pillow or replacement of a fallen pillow would not constitute a
change in positioning devices that would require a change in the
care plan. Tr. 2814-2816, 2818. Ms. Patience testified also, in
response to Petitioner's counsel's questioning, that, if a
resident's restraint was made to fit properly upon becoming
loosened, this would not require a change in the care plan. Tr.
2818.
According to Ms. Patience, however, the addition or repositioning
of pillows could constitute a change which would necessitate
reporting it in the care plan if the pillows were being used as a
postural support. Tr. 2564-2567; See also Tr. 2816. Ms. Patience,
in response to my questioning, testified, "If the pillows need to
be in a particular configuration in order to keep the resident in
a particular position, then that should be placed on the Care
Plan." Tr. 2565; See also Tr. 2566-2567.
83. Ms. Downing testified that the care plan "doesn't show a
change in the seating system", but "shows that a western saddle was
added to the seat" on 4/12/94. Tr. 2314, 2316.
84. According to Ms. Downing, a western saddle is not a
postural seating system or a part of one. Tr. 1921. Ms. Downing
described the western saddle as being "a cushion, . . . with a
saddle horn to prevent them scooting forward. It's not considered
a seating system. . . It's designed to prevent [the individual]
from sliding out of the wheelchair." Tr. 2315; see Tr. 1921.
85. Petitioner's plan of correction, which is dated 1/31/94, is
presumed to contain the corrective actions it has implemented in
response to the deficiencies cited in the HCFA 2567 by the survey
team.
With respect to resident 20 and this alleged deficiency, the
complete text of Petitioner's plan of correction is:
Residents shall be assessed and their care plan approaches
updated to address contracture relative to treatment.
Resident #20 has been assessed by interdisciplinary staff to
address his needs for proper positioning to prevent further
contracture and instructed staff in his care needs. The residents
care plan has been updated to reflect changes.
HCFA Ex. 2 at 11.
86. Ms. Downing testified also that the care plan indicates
that there were no changes in positioning devices until 4/12/94.
Tr. 2317.
87. I have concluded that HCFA has sufficient evidence of record
to support a strong inference of the existence of a care plan which
included the physician's order for the E-Z boot. Once such
inference is established, Petitioner, who is in possession of the
medical records for this resident, has the burden of refuting the
inference by offering the care plan into evidence.
88. There was no evidence offered by HCFA or Petitioner on this
lab monitoring action set forth in the care plan. Accordingly, I
can make no findings on whether this aspect of the care plan was
met.
89. By actual count, it is an 18 day period, approximately two
and one half weeks.
90. The resident's skin turgor was noted to be "warm & dry" or
"good," no edema was noted and his mucous membrane was noted to be
moist. P. Ex. 25 at 3-4.
91. There is no indication in the HCFA 2567 that the facts of
this deficiency were to be cross-referenced to another citation,
such as F 298, that pertains to the need to revise assessments.
92. The transcript contains a reference defining dysphasia as
difficulty in swallowing. Tr. 231. However, the definition of
dysphasia is "loss of or deficiency in the power to use or
understand language as a result of injury to or disease of the
brain". Webster's Ninth New Collegiate Dictionary 391 (9th ed.
1990). The word dysphagia is defined as "difficulty in
swallowing." Id. Since the witness testifying defined the word as
meaning difficulty in swallowing, I can only conclude that the
transcript reference at Tr. 231 should read dysphagia and not
dysphasia. The rehabilitation screen confirms this conclusion,
for, in the "feeding" section, there is a box checked indicating
resident 20 had dysphagia. P. Ex. 26 at 3.
93. This resident is now deceased. I have no information which
suggests this resident's death was related to the circumstances of
this deficiency.
94. The following testimony is noteworthy:
Judge Steinman: In light of what counsel just showed
you, in terms of these charts, do they reflect a routine ambulation
program, or were you referring to something else?
Witness: I don't know. According to what he just showed
me, they would infer that the resident was being ambulate[d];
you're correct. . . .
Tr. 1530.
95. According to Ms. Cox, who prepared these findings, she
inadvertently left out the word "not". Tr. 1102. Petitioner does
not challenge this explanation and assumed that was the surveyor's
intention. P. Br. at 121.
96. Ms. Downing, in response to my inquiries as to the meanings
of the different markings in the blocks on the flow sheets,
admitted "[t]hat's why we all have problems with these when we --
we need to be working with the staff to understand what they are.
And part of our revision of the forms is to attempt the consistent
method of interpreting these." Tr. 2050.
97. Ms. Cox testified that "HS" means hour of sleep which in
the context of this form means at bedtime. Tr. 1375.
98. There is no indication of tube feeding of this patient.
99. Without a further explanation, I assume "NA" means not
applicable.
100. This resident has "NA", "N" and checks in the various
blocks for the month of December 1993. See P. Ex. 30 at 11-12.
Again, there is no indication of tube feeding.
101. This resident apparently was receiving tube feeding for
the month of December 1993. This can be discerned from the "GT"
notations in meal blocks on the flow sheets. See Tr. 2045.
102. There is no indication that this resident was receiving
tube feeding. P. Ex. 30 at 17.
103. There is no indication that this resident was receiving
tube feeding.
104. There is no indication of tube feeding.
105. There is no indication of tube feeding.
106. There is an indication that this resident was being fed by
staff and receiving double portions during December 1993. P. Ex.
30 at 39. There is nothing to suggest that a snack was
contraindicated for this resident.
107. This resident apparently was on regular puree diet and had
the ability to feed herself. P. Ex. 30 at 40-42. There is no
reason in the record for the lack of snacks at bedtime.
108. There is a reference to a regular diet but no indication
of tube feeding. There is no reason given for the lack of snacks
at bedtime. P. Ex. 30 at 61.
109. There is an indication that this resident was on a regular
NAS diet for the entire month of December 1993. P. Ex. 30 at 64.
Her flow sheets indicated "NA" for the first half of the month and
checks for the latter half. Id. at 62-63. I cannot discern from
these flow sheets the reason for the change in snack service or why
no snack was provided in the first half of the month.
110. Ms. Downing indicated that this marking means no snack.
Tr. 2049-2050.
111. This resident has "NA", "N" and checks in the various
blocks for the month of December 1993. See P. Ex. 30 at 11-12.
Again, there is no indication of tube feeding.
112. There is no indication that this resident was receiving
tube feeding. P. Ex. 30 at 17.
113. There is no indication that this resident was receiving
tube feeding.
114. There is no indication of tube feeding.
115. This resident apparently was on NAS diet. This diet is
not explained in the record. I do note she was an independent
eater but had dietary restrictions. There is no suggestion that a
snack could not be provided that was consistent with this
resident's diet. P. Ex. 30 at 25-27.
116. Ms. Downing indicated that this marking means no snack.
Tr. 2049-2050.
117. Again, there is no indication that this resident is
receiving tube feeding. P. Ex. 30 at 17.
118. This flow sheet also contains checks.
119. This resident apparently was receiving a supplementary
nourishment. P. Ex. 30 at 31.
120. This resident apparently was receiving gastric feeding.
121. Ms. Downing explained that there are three types of tube
feedings used at Petitioner. A "GT is for gastrostomy tube. "JT"
is for jejunostomy tube which is inserted lower in the intestinal
tract. "NT" is a nasalgastric tube which goes through the nose to
the stomach of the resident. Tr. 2051-2052.
122. The State surveyors indicated that before the end of a
survey they generally discuss the deficiencies found with the staff
of the facility being surveyed. Here, the charge nurse was put on
notice by Ms. Cox that the snack policy was under review.
123. SOM 250 provides support for this conclusion. A strong
potential for harm can be a basis for determining that a negative
outcome results from a deficient practice. An example is cited
relating to the potential for infection when "an observed facility
practice is so divergent from accepted principles of practice that
a future negative outcome or harm is probable." HCFA Ex. 13 at
P-30. These are precisely the circumstances of the cited
deficiency.
124. The somewhat confused state of the testimony of the
surveyor illustrates the risk inherent in HCFA's strategy of
relying on the privilege of deliberative process and suppressing
the surveyors' notes. Because HCFA chose to rely solely on the
testimony of the surveyors in proving Petitioner's deficiencies,
the surveyors were forced to give testimony on specific factual
allegations without having their notes available to assist them.
Moreover, to the extent that the surveyors relied on specific
resident records when citing Petitioner for a given deficiency
during the survey, these documents were withheld also as part of
the deliberative process privilege. Consequently, to prove the
existence of the cited deficiencies, HCFA was forced to rely on a
combination of 1) surveyors testifying without their notes and 2)
documents offered by Petitioner. This led to confusing testimony
because the documents that would best refresh the surveyor's
recollection of the cited deficiency (the surveyors' notes or
copies of the specific documents they reviewed) were not available
to the surveyors during testimony. In future cases, HCFA might be
better served if its surveyors created notes that were strictly
factual in nature and devoid of deliberative matters or other
information that, if revealed, might compromise HCFA's survey
process. This documentation could be used to prove the existence
of the cited deficiencies in a clear, direct manner, and serve to
refresh the recollection of surveyors who are now forced to testify
strictly from memory. Had the surveyors' notes been available to
be used by the parties in this case, it may have reduced the
acrimony and lengthy argument which, in turn, led to the voluminous
hearing record.
125. I do not restate the findings for F 462, which are set
forth at HCFA Ex. 2 at 19-24.
126. I do not restate the remainder of the alleged deficiency,
which is set forth at HCFA Ex. 2 at 25.
127. HCFA's counsel stated that HCFA had not presented any
testimony on F 527. Tr. 2065.