CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Clermont Nursing and Convalescent Center,

Petitioner,

DATE: September 25, 2003
                                          
             - v -
 

Centers for Medicare & Medicaid

 

Docket No.C-00-340
Decision No. CR1087
DECISION
...TO TOP

DECISION

Petitioner, Clermont Nursing and Convalescent Center, was not in substantial compliance with Medicare and Medicaid participation requirements during the period September 3, 1999 through October 23, 1999. Due to Petitioner's failure to be in substantial compliance, the Centers for Medicare and Medicaid Services (CMS) (1) had a basis for imposing a civil money penalty (CMP) in the amount of $650 per day for the period of noncompliance. The CMP is reasonable.

I. PROCEDURAL HISTORY

On September 3, 1999, the Ohio Department of Health (the State agency) completed an annual and extended survey of Petitioner's facility. Petitioner was a 208-bed long-term care center located in Clermont County, Ohio. Petitioner was licensed by the Ohio Department of Health and certified to participate in the Medicare and Medicaid programs. The State agency found Petitioner not in substantial compliance during the survey that ended September 3, 1999 and issued a statement of deficiencies (SOD) reflecting its findings which was provided to Petitioner by notice dated September 13, 1999. A follow-up survey was completed on November 4, 1999 and the State agency found that Petitioner had achieved substantial compliance effective October 24, 1999. CMS sent Petitioner a notice dated January 25, 2000, imposing a $650.00 per-day CMP for the period September 3, 1999 through October 23, 1999, a total of $33,150.00. Court Exhibit. 1.

Petitioner requested a hearing through counsel on March 22, 2000. On March 24, 2000, the case was assigned to Administrative Law Judge Jill Clifton for hearing and decision. (2) On March 21, 2001, the case was reassigned to Chief Administrative Law Judge Marion Silva for hearing and decision. On October 16, 2001, the case was reassigned to me for hearing and decision.

The hearing in this case convened on April 1, 2002 in Cincinnati, Ohio and concluded on April 3, 2002. CMS called four witnesses: Debbie Truett, Ann Alden, Vince Borell, and Sharon Dunn. Petitioner presented testimony of seven witnesses: Deborah Highley, Melinda Fields, Jennifer Ducker, Chera Osborne, Tammie Campton, Beth Johnson, and Kimberly Parks. The transcript of the proceedings totals 555 pages. (3)

The parties' Joint Stipulation of Undisputed Fact was marked and admitted as Court Exhibit 1. Petitioner offered Petitioner's exhibits (P. Exs.) 1 through 29 without objection, except counsel for CMS noted that certain of the documents consisted of hearsay, which might affect their probative value. Transcript (Tr.) 27-28. CMS offered exhibits 1 through 80. (4) CMS Exhibits 1 through 43, 51 through 58, and 60 through 80 were admitted without objections from Petitioner. Tr. 24-25, 120. Petitioner objected to the admission of CMS Exs. 44 through 50 and 59 on grounds that they contained hearsay, that the authors of the documents were not present to testify or be cross-examined, and that admission of the documents would be prejudicial to Petitioner. Tr. 13-26. I subsequently ruled that CMS Exs. 44 through 50 and 59 were authentic, relevant, and admissible, and that Petitioner's objections would be considered as going to the weight to be accorded the documents in my decision-making. Tr. 136-39, 333-34. Except as specifically noted in this decision, the documents to which Petitioner interposed objections have not been accorded any weight and have not been considered adversely to Petitioner.

The parties completed post-hearing briefing on July 22, 2002. (5) Thereafter, counsel for CMS filed an undated motion for leave to file a sur-reply with the sur-reply attached. The motion and sur-reply were received at the Civil Remedies Division on August 6, 2002. Petitioner filed no response to the motion. Upon closer inspection, I find no certificate of service attached to the pleading or any other evidence that service was effected upon Petitioner. Rather than further delay a decision in this case, the sur-reply and motion will remain part of the record of proceedings in this case, but I have not considered the sur-reply in making my decision.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

The following findings of fact are based upon the exhibits admitted and the transcript of the proceedings. Citations to transcript pages and exhibit numbers related to each finding of fact may be found in the analysis section of this decision.

1. On September 3, 1999, the State agency completed an annual and extended survey of Petitioner's facility.

2. Petitioner was, at all relevant times, authorized to participate in the Medicare and Medicaid programs.

3. The State agency alleged that Petitioner was not in substantial compliance from September 3, 1999 through October 23, 1999, based on the survey which ended September 3, 1999.

4. Petitioner timely requested a hearing.

5. Resident 168 developed new pressure sores while at the facility; specifically, On August 31, 1999, a surveyor observed two new pressure sores on the scrotum and one on the coccyx.

6. Resident 168's treatment records clearly show a worsening of his left hip pressure sore.

7. The sore on Resident 43's ankle at the time of the survey could have been avoided had Resident 43 been placed in socks and slippers on August 17, 1999, as ordered by his doctor, or had tape been placed over the hole in his Spanko boot.

8. Resident 171, who was admittedly at risk for the development of pressure sores, did develop a pressure sore on her left ankle.

9. Petitioner implemented no interventions to prevent development of pressure sores on Resident 171's left ankle even though it was obvious that Resident 171 was spending a significant amount of time resting on her left side and had nearly constant involuntary leg movements which caused friction with the bed sheets.

10. Petitioner failed to follow Resident 50's care plan and Resident 50 developed new pressure sores as a result.

11. Resident 72 experienced a worsening of an existing pressure sore and development of a new sore.

12. Petitioner failed to reposition Resident 72 in accordance with her care plan and failed to provide timely incontinent care, as evidenced by the presence of dried feces on the resident's skin.

13. Petitioner knew or should have known that Resident 147 was at risk for elopement.

14. The netted door guards required by Resident 147's plan of care were not in place during the survey.

15. Petitioner knew or should have known that Resident 72 was at risk of falling from bed given that: 1) she repeatedly tried to get out of bed; 2) the restraint free alarm apparently failed to sound when she attempted to get out of bed; 3) the type of alarm specified by her doctor was not used; and 4) on at least one day in July, Petitioner's staff found it necessary to use two side-rails to keep Resident 72 from falling from bed

16. Resident 72 fell from bed on August 22, 1999, and was injured.

17. Resident 6's care plan required the use of a pressure sensitive bed alarm to help prevent falls, but the alarm was not functioning at the time of the survey.

18. Petitioner knew or should have known of the risk that Resident 14 would attempt to get out of bed and fall and injure himself.

19. Petitioner's use of a restraint free alarm, three-quarter length side-rails, and a single mat on one side of the bed were all ineffective to minimize or eliminate the risk that Resident 14 would attempt to get out of bed, fall, and injure himself.

20. Petitioner knew that Resident 163 was at risk of falling forward from his wheelchair and that a restraint free alarm was required to minimize or eliminate the risk.

21. During the survey, Resident 163's restraint free alarm was not attached to him while he was in his wheelchair.

22. Petitioner knew or should have known that a roll-belt was improperly applied to Resident 60 on August 31, 1999 at around 3:15 p.m., because the roll-belt was attached to a non-moveable part of Resident 60's bed, creating a risk of injury to Resident 60.

B. CONCLUSIONS OF LAW

1. I have jurisdiction to decide this case.

2. A participating facility is required to go beyond merely doing what seems reasonable to prevent and treat pressure sores and, instead, must always furnish what is necessary to prevent new pressure sores from developing or existing pressure sores from becoming worse, unless the development of new sores or aggravation of existing sores is clinically unavoidable.

3. CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(c) (F Tag 314) in the examples of residents 168, 43, 171, 50, and 72, by showing the development of new pressure sores or the worsening of existing sores.

4. Petitioner failed to show by a preponderance of the evidence that, for residents 168, 43, 171, 50, and 72, it went beyond merely what seemed reasonable, but rather that it furnished what was necessary to prevent new pressure sores from developing or existing pressure sores from becoming worse. Likewise, Petitioner failed to prove that the development of new sores or aggravation of existing sores was clinically unavoidable. Koester Pavilion, DAB No. 1750, at 32 (2000).

5. Residents 168, 43, 171, 50, and 72 suffered actual harm as a result of the violation of 42 C.F.R. § 483.25(c).

6. Facilities are not strictly liable as guarantors of good outcomes of the care they provide residents, but 42 C.F.R. § 483.25(h)(2) (F Tag 324) requires that a facility provide adequate supervision and assistive devices to prevent accidents; prevention consists of reducing or eliminating the risks that lead to accidents.

7. In order to evaluate a facility's compliance with section 483.25(h)(2), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25-26. Section 483.25(h)(2) requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision and assistive devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks.

8. CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(h) in the examples of residents 147, 72, 6, 14, 163, and 60, by failing to provide adequate assistive devices or supervision to eliminate or reduce reasonably foreseeable risks of accidental injury.

9. Resident 72 suffered actual harm as a result of Petitioner's violation of 42 C.F.R. § 483.25(h).

10. Petitioner was not in substantial compliance from September 3, 1999 through October 23, 1999.

11. A CMP of $650 for each day of substantial noncompliance from September 3, 1999 through October 23, 1999, is reasonable in this case.

III. DISCUSSION

A. ISSUES

1. Whether there is a basis for the imposition of an enforcement remedy; and,

2. Whether the remedy imposed is reasonable.

B. APPLICABLE LAW

The Social Security Act (Act) sets forth requirements for long-term care facilities, including SNFs and NFs, participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919 (42 U.S.C. §§ 1395i-3; 1396r). (6) The Secretary's regulations governing long-term care facilities participating in the Medicare program are found at 42 C.F.R. Part 483. Survey, certification, and enforcement procedures for all long-term care facilities, including SNFs and NFs, are contained in 42 C.F.R. Part 488.

A SNF and/or NF must maintain substantial compliance with program requirements as set forth at 42 C.F.R. Part 483 to participate in the Medicare and Medicaid programs. If the State or CMS finds violations of Part 483 requirements or deficiencies in a facility's operation during a survey, the deficiencies noted must present no greater risk to resident health or safety than the "potential for causing minimal harm" or the facility will be found not in substantial compliance and a certificate of noncompliance will issue. 42 C.F.R. §§ 488.302 and 488.330. If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in section 1819(h) of the Act (42 U.S.C. § 1395i-3(h)) and 42 C.F.R. § 488.406. The purpose of the authorized remedies is to "ensure prompt compliance with program requirements." 42 C.F.R. § 488.402(a). Remedies are applied on the basis of the scope and severity of the noncompliance found during surveys. 42 C.F.R. § 488.402(b). The factors to be considered by CMS when selecting remedies are set forth at 42 C.F.R. § 488.404.

A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. § 488.408(g)(1); see also 42 C.F.R. §§ 488.330(e) and 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing remedies. 42 C.F.R. § 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. §§ 498.3(b)(13) (7) and (d)(10)(ii). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000). The Departmental Appeals Board (DAB) has long held that the net effect of these regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750.

CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions or that it had an affirmative defense. Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). Black's Law Dictionary (7th Ed.) provides several definitions of "prima facie case," one of which is sufficient:

A party's production of enough evidence to allow the fact-trier to infer the fact at issue and rule in the party's favor.

The DAB defined the requirements for a prima facie case in its decision in Hillman:

HCFA must identify the legal criteria to which it seeks to hold a provider. Moreover, to the extent that a provider challenges HCFA's findings, HCFA must come forward with evidence of the basis for its determination, including the factual findings on which HCFA is relying and, if HCFA has determined that a condition of participation was not met, HCFA's evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611, at 11. If a provider appeals an enforcement decision, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy.

C. ANALYSIS

1. There is a basis for the imposition of an enforcement remedy.

The SOD includes 23 deficiency citations with, in most cases, numerous examples cited. (8) My analysis of this case includes only those deficiencies alleged by CMS to be most severe. These deficiencies alone are a sufficient basis for the enforcement remedies imposed by CMS, and there is no need to consider the other cited deficiencies. Beechwood Sanitarium, DAB No. 1824 (2002) (ALJ not required to make more findings than are necessary to support the remedies imposed, but has the discretion to exercise judicial economy). CMS alleges that the deficiencies cited as violations of 42 C.F.R.§ 483.25(c) (F Tag 314, Pressure Sores) and 42 C.F.R. § 483.25(h)(2) (F Tag 324, Accident Prevention) are at a scope and severity level of H and G, respectively. (9) Scope and severity levels H and G reflect the CMS (10) judgment that the deficiencies involved actual harm that did not amount to immediate jeopardy. Level G further reflects an isolated instance and level H reflects that CMS found a pattern of this deficiency. State Operations Manual (SOM) § 7400E. (11) The regulations require category 2 remedies for deficiencies at the level of G and H. Those remedies include denial of payment for new admissions (DPNA), denial of payment of all Medicare/Medicaid eligibles, and/or a CMP in the range of $50 to $3,000 per day. 42 C.F.R. § 488.408. All the other cited deficiencies in this case are at level D, E, or F, for which only category 1 remedies are required. Category 1 remedies do not include authority to impose a CMP. (12)

a. Petitioner violated 42 C.F.R. § 483.25(c), F Tag 314, Quality of Care (Pressure Sores).

The regulation violated provides:

§ 483.25 Quality of care. 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.

* * *

(c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that- (1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and (2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

The application of this regulation is well-established by decisions of various appellate panels of the DAB. Koester Pavilion, DAB No.1750, and Cross Creek Health Care Center, DAB No.1665, are leading decisions in this area. The DAB has noted that the pressure sore regulation contains two prongs: (1) a facility must ensure a resident who enters the facility without sores does not develop sores unless the resident's clinical condition demonstrates sores are unavoidable; and (2) a resident with pressure sores must receive necessary treatment and services to promote healing, prevent infection and prevent new sores. With respect to prevention and treatment of pressure sores, the DAB has concluded that a facility bears a duty to "go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32; see also, Meadow Wood Nursing Home, DAB No. 1841 (2002) (loose dressing contaminated with fecal matter constitutes violation); Ridge Terrace, DAB No. 1834, at 15-16 (a single observation by a surveyor of a nurse aide cleaning an open sore area with a stool-stained washcloth was sufficient to sustain a deficiency finding under this Tag). In order to establish a prima facie case, CMS must show either: (1) that a resident who entered Petitioner's facility without pressure sores developed such sores at Petitioner's facility; or (2) a resident at Petitioner's facility had one or more pressure sores that became worse, or became infected, or the resident developed additional sores, indicating the facility did not provide treatment and services to promote healing, prevent infection, and prevent new sores from developing. If CMS makes a prima facie showing, Petitioner then bears the burden of showing that the development of pressure sores or their worsening was "clinically unavoidable."

Respondent's evidence, offered and admitted without objection, provides a primer on the identification, care, and treatment of pressure sores. A pressure sore is a skin lesion which usually forms over a bony prominence due to unrelieved pressure that stops blood flow and causes damage to the tissue. Friction or shear are factors that may contribute to the formation of a pressure sore. CMS Exs. 74, at 6; 76, at 11; 79, at 15.

The observations, findings, and conclusions of the surveyors related to the deficiency in this case are found in the SOD for the survey completed on September 3, 1999. CMS Ex. 1, at 36-44. The surveyors concluded, based on direct observation, interviews, and records reviews, that the facility failed to ensure six residents with pressure sores, or a history of pressure sores, received necessary treatment and services to promote healing, prevent infection, and prevent new sores - the second prong of the regulation. The six residents include Residents 168, 43, 45, 171, 50, and 72. Petitioner argues generally regarding all the examples that the residents had multiple clinical conditions that produce skin problems or that the residents made individual choices that caused pressure sores. P. Brief, at 15.

Example 1 - Resident 168 (CMS Ex. 1, at 36-39): Regarding Resident 168, the surveyor reported that facility records reflected that this resident had been identified at risk for pressure sores as he was non-ambulatory, incontinent, and had diabetes mellitus. At the time of the survey, the records of Resident 168 reflected that he had two Stage II pressure sores, one on the left hip (13) and one on the right buttock. The records also indicated Stage I pressure sores on both hands. The surveyor observed two of the facility nurse aides transfer Resident 168 to his bed at 1:20 p.m. on August 31, 1999 -- he had been observed sitting in his wheelchair since 9:55 a.m. The two aides told the surveyor that Resident 168 was "okay," so they would not change his incontinent brief, but the surveyor asked to see the brief. When the surveyor viewed the brief she noted that the time the incontinent brief was applied was written on the brief, in this case, 6:20 a.m. The surveyor also observed that the brief was urine saturated and, when it was removed, the surveyor observed two open bloody sores on the scrotum of Resident 168 and a Stage II pressure sore on his coccyx. The nurse aides did not report the new sores as required by facility policy and, in fact, the sores were not reported and documented until observed by nursing staff and aides the next day, September 1, 1999. Three additional Stage II pressure sores, not previously identified or documented by staff, were identified on September 1, 1999, on the left knee, coccyx and upper right side of the gluteal fold. The surveyors also note that, on September 2, 1999, Resident 168 was observed lying on his left hip, where he had an open pressure sore, for more than an hour. The resident was then put in a wheelchair and left for nearly two hours without any offer of assistance with toileting or incontinence care. The surveyor alleges that facility records show that the pressure sore reported on the left hip on August 31, 1999 had worsened by September 3, 1999. The surveyor also notes that on September 2, 1999, during a bed bath, it was discovered that Resident 168 had a Stage II sore on his left elbow and an old occlusive adhesive dressing sticking near the elbow. Neither of the aides who bathed Resident 168 noted the dressing or the sore, and the facility records did not mention the sore or any dressing, and the wound care nurse was equally unaware of the sore or any treatment.

Petitioner addressed the allegations regarding Resident 168 in its plan of correction dated October 24, 1999, which appears in the right column of the SOD for the survey that ended September 3, 1999. CMS Ex. 1, at 36-38. Petitioner notes Resident 168 was on Keflex and the left hip ulcer had improved, in that it was draining only a small amount of yellow serosanguinous fluid with no foul odor (id. at 36), in contrast to the surveyor's observation of September 3, 1999 (id. at 37). Nonetheless, the sore remained worse than it was described in Petitioner's records of August 31, 1999, when it was described as smaller with no drainage or foul odor. CMS Ex. 40, at 6. Petitioner did not deny the development and presence of the scrotum sores but notes they were healed by September 9, 1999. CMS Ex. 1, at 36. According to the plan of correction, Resident 168's hands were being treated by cleaning with soap and water, thorough drying and the use of hand splints that were actually obtained in August. Id. Of the three new Stage II sores that the surveyors allege were discovered on September 1, 1999, Petitioner alleged there was no sore on the left knee or left heel. Id.  According to Petitioner, the area noted on the left elbow with the old bandage was actually a skin tear (it is not noted whether the skin tear was documented or that any treatment had been given by Petitioner) (14) that had healed by September 6, 1999. Id.

In its plan of correction, Petitioner did not deny the following observations recorded by the surveyor: 1) that Resident 168 was left in a saturated brief until the surveyor questioned the nurse aides; 2) that there were previously undocumented and untreated pressure sores on the resident's scrotum and coccyx which the nurse aides failed to report; 3) that the resident was left lying on a pressure sore for nearly an hour; 4) that he was left sitting in his wheelchair without toileting assistance or a check for incontinence; 5) that the sore on the left hip deteriorated; and 6) that there was no documentation of the presence of or treatment for the skin tear on the left elbow. Id.

Debbie Truett, a surveyor with the Ohio Department of Health, appeared and testified at the hearing. Ms. Truett is a registered nurse with experience as she described on the record. Tr. 41-43. She was hired in 1993 and trained as a facility surveyor. Tr. 43. She participated in the survey of Petitioner's facility, which began on August 30, 1999. Tr. 44-45.

Ms. Truett provided unrebutted testimony regarding pressure sores. She testified that risk factors include malnutrition, disability, contractures, incontinence, and loss of sensation. Incontinence increases the risk of pressure sore development, as it keeps the skin moist increasing the risk of skin breakdown; the acidic nature of urine contributes to skin breakdown; and bacteria from fecal matter aggravates pressure sores. Tr. 51-52. Pressure sores tend to form on pressure points or a bony prominence such as hip bones, elbows, coccyx, knees, heels, and ankles. There are four stages of pressure sores. Stage I is an area of persistent skin redness that does not disappear when pressure is removed, indicating initial tissue damage without an open wound. A Stage II pressure sore includes a superficial open area which appears like a shallow crater. A Stage III pressure sore is deeper and involves the dermis and epidermis. A Stage IV pressure sore is deeper still, involving the full thickness of the layers of skin and underlying muscle down to the bone. Tunneling indicates a hole in the pressure sore that is deeper than the rest of the sore. Tr. 54-56. Her testimony is consistent with the stages of pressure sores reflected on the pressure ulcer progress report form used by Petitioner. See, e.g., P. Ex. 7, at 35. Ms. Truett provided testimony regarding treatment and prevention of sores, including a listing of various types of pressure relieving devices. Tr. 56-59.

Ms. Truett made the observations recorded in the SOD related to Resident 168. Tr. 80-88; CMS Ex. 40; CMS Ex. 52, at 2, 4, 6, 8. Her testimony was consistent with the written observations related to Resident 168. Ms. Truett clarified that the new pressure sore observed on Resident 168's coccyx was bleeding when his saturated brief was removed on August 31, 1999. Tr. 83; CMS Ex. 52, at 2.

Petitioner presented the testimony of Ms. Kimberly Diane Parks at hearing. Ms. Parks is a registered nurse with the experience she described on the record. Tr. 500-02. She is Regional Director for Strategic Nursing Systems with responsibility for three long-term care facilities including the Petitioner. Tr. 501. She arrived at the facility shortly after the survey team entered on August 30, 1999, because she was paged. Tr. 521. Ms. Parks reviewed the SOD and facility records and interviewed staff regarding allegations in the SOD. She opined generally and without objection that she did not agree with the allegations of the SOD. Tr. 502-03.

Regarding Resident 168, Ms. Parks testified in response to a leading question that he had no untreated pressure sores, but she did not specify the time she referred to and she did not clarify whether she took issue with the specific observations of Ms. Truett. See Tr. 508. Ms. Parks also testified that, after the survey, Resident 168 was diagnosed with a neurogenic bladder. Id. She stated that that may have been the reason for the times written on Resident 168's brief. Id. Her testimony on this point is inconsistent with that of another of Petitioner's witnesses, who indicated that writing times on briefs was a common practice, but for different reasons. Tr. 442-43. Ms. Parks stated that with a neurogenic bladder, Resident 168 may not have urinated between 6:20 a.m. and the early afternoon, and that the brief may have been saturated when Ms. Truett made her observation because "he could have gone all at once and emptied a very full bladder." Tr. 509. Ms. Parks did not address why the aides made no report of the pressure sores observed when the brief was removed and why the sores were not documented until the next day. Ms. Parks noted that Resident 168 had a history of being combative, but she offered no opinion as to how this might have impacted the surveyor's observations. See Tr. 510. Ms. Truett gave no indication in her testimony or in the notes she made contemporaneous with her observations, that Resident 168 was being combative when she made those observations.

Petitioner argues in its post-hearing brief that Resident 168 had no "untreated pressure sores" and that pressure sores were treated per doctor's orders. P. Brief at 15-16. This assertion, while consistent with the testimony of Ms. Parks, is no more specific than Ms. Parks as to when Resident 168 had no "untreated pressure sores." The credible testimony of Ms. Truett is that she saw sores on Resident 168's scrotum and coccyx that were neither recorded nor treated until on or after September 1, 1999, and I have been presented no medical records showing any documentation or treatment by Petitioner thereafter. Petitioner argues that Resident 168 "was being evaluated for a neurogenic bladder," implying the evaluation was occurring during the survey. Petitioner cites the testimony of Ms. Parks (Tr. 508-09) in support of this argument. P. Brief at 15-16. I note that Ms. Parks never testified that Resident 168 was undergoing evaluation for a neurogenic bladder at the time of the survey. Rather, she testified that Resident 168 was diagnosed as having a neurogenic bladder some time after the survey; that writing a time on a resident's diaper may be part of the process of evaluating for a neurogenic bladder; and that it is possible that one with a neurogenic bladder may have a diaper placed and timed at 6:20 AM and not void until there is a sudden release of urine in the early afternoon. Petitioner implies, but does not specifically argue, that Resident 168's diaper may have been dry when checked by the nurse aides, that Resident 168 then had a sudden release of urine due to his neurogenic bladder, and was found wet when the aides checked again at the request of surveyor Truett, all within the span of a few minutes. Petitioner also argues that Resident 168 was at risk for the development of pressure sores but never specifically asserts that pressure sores were unavoidable. P. Brief at 15-16.

Petitioner offered and had admitted 88 pages of the facility treatment records for Resident 168 as P. Ex. 7. The records contain no notes regarding evaluation or diagnosis of a neurogenic bladder condition. The records reveal that Resident 168 had a history of pressure sores which were identified and treated. A Physician's Order form indicates treatment for a pressure sore on the right heel, which had resolved by May 11, 1999. P. Ex. 7, at 13. On May 19, 1999, two Stage II pressure sores were identified on Resident 168's right buttock, and a small pink area that was not staged was noted on his lower left buttock. By May 25, 1999, the pink area on the lower left buttock had resolved and the two pressure sores on the right buttock had improved. P. Ex. 7, at 35-36. June 2 and 7, 1999 reports show signs of infection in one of the pressure sores on the right buttock. P. Ex. 7, at 36-37. By July 13, 1999, the pressure sores on the right buttock were staged as Stage I, and by August 4, 1999, they were reported as resolved. P. Ex. 7, at 38-39. On June 16, 1999, Resident 168 was noted to have a red bruised area on his left hip, a Stage I pressure sore on his coccyx, and a Stage I pressure sore at the left gluteal fold. P. Ex. 7, at 42. The bruise on the left hip was reported to be resolved on June 21, 1999 and the Stage I sore on the left gluteal fold was healed. P. Ex. 7, at 43. As of June 25, 1999, the Stage I sore on the coccyx was healed. Id. A monthly occupational therapy note dated August 27, 1999 indicates that Resident 168 did not have hand splints but needed them due to contractures and skin breakdown, and splints were obtained and use initiated. P. Ex. 7, at 73. A Physician's Order form contains a note from August 17, 1999, that indicates an "early Stage II" sore on the right buttock and a "late II early III" on the left hip. P. Ex. 7, at 5. An Immediate Needs Care Plan bearing dates from September 4, 1999 through November 1, 1999, reflects use of Keflex and Duricef (both antibiotics) for treatment of Resident 168's left hip pressure sore and an appointment on October 7, 1999 at a wound care center for treatment of the left hip pressure sore, which was not healing. P. Ex. 7, at 26. The records for Resident 168 produced by Petitioner do not mention any pressure sores on Resident 168's scrotum or the pressure sore observed by Ms. Truett on Resident 168's coccyx.

Based on the foregoing summary of the evidence, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(c) with respect to Resident 168. Clearly, Resident 168 developed new pressure sores while at the facility, specifically the two on the scrotum and the one on the coccyx observed by Ms. Truett on August 31, 1999. (15) The existence of those sores and the fact they were new has never been denied by Petitioner. Further, while Ms. Parks speculates that the wet diaper observed by Ms. Truett was due to a sudden flooding of urine, her testimony is totally speculative on this point. Petitioner has pointed to no contemporaneous or other evidence that Resident 168 was experiencing symptoms related to a neurogenic bladder or that he was being evaluated for that condition at the time of the survey. I credit Ms. Truett's testimony highly on this point, as the conduct of the aides provoked her to ask to see Resident 168's brief. The brief was totally saturated, another point not denied by Petitioner, and the evidence is undisputed that the brief had not been changed for nearly five hours. Further, the lack of proper toilet assistance for Resident 168 is totally consistent with Ms. Truett's later observation that Resident 168 was left sitting for an extended period with no offer of assistance. Finally, Resident 168's treatment records from Petitioner's facility admitted as evidence by CMS and Petitioner, clearly show a worsening of the left hip pressure sore that existed at the time of the survey.

Because CMS made a prima facie showing, the burden is upon Petitioner to show that Resident 168's pressure sores were unavoidable due to his clinical condition. Petitioner never makes the showing and, in fact, does not argue in its briefing that Resident 168's pressure sores were unavoidable. I certainly recognize from Resident 168's diagnoses that he was at risk for the development of pressure sores, and his history in the facility shows he in fact developed many pressure sores during a six-month period. However, his records also show relatively rapid resolution of his sores so that I cannot infer from his history that sores were unavoidable. Petitioner also failed to offer any expert testimony that Resident 168's ulcers were unavoidable. Accordingly, I conclude Petitioner has failed to establish its affirmative defense. (16) Petitioner has failed to meet its duty to "go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32.

Example 2 - Resident 43 (CMS Ex. 1, at 39-40): According to the SOD, Resident 43 was admitted to the facility on April 15, 1999, with Stage IV pressure sores on both heels. The surveyors acknowledge that, at the time of the survey, one heel was completely healed and the other near complete with a dry scab. However, on September 1, 1999, the surveyor observed a new Stage II pressure sore on the left lateral bony prominence of the ankle, apparently caused by rubbing around an air hole in one of the vinyl covered foam boots he wore to protect his heels. The problem was resolved by Petitioner's staff by placing adhesive tape inside the boot over the hole. The survey notes that the sore was not documented or treated before the surveyor called it to staff's attention.

Petitioner, in its plan of correction, did not deny the surveyor's allegations, but rather noted that an order for treatment was obtained and the resident's sores continued to improve. CMS Ex. 1, at 36.

Ms. Parks testified for Petitioner regarding Resident 43. She clarified that Resident 43 had two Stage IV pressure sores on both heels when admitted to the facility. Resident 43 was diabetic and the sores were from constant wear of cowboy boots that had to be surgically removed. The facility provided Resident 43 "Spanko boots" to keep pressure off his heels while he lay in bed and to facilitate healing. Although he was not supposed to, he walked in the Spanko boots which caused the rubbing and sore that is noted in the survey. Ms. Parks testified that if the Spanko boots alone were the problem, it would have been noticed while he was wearing the boots in bed but still refused to walk. Ms. Parks did not address the effectiveness of simply covering the hole in the Spanko boots with adhesive tape or how Resident 43 was able to walk in the Spanko boots without staff intervention. Tr. 510-12.

Petitioner offered, and I admitted, 48 pages of Resident 43's treatment records from the facility as P. Ex. 10. The record clearly shows that Resident 43 was admitted to Petitioner's facility with stasis ulcers due to vascular insufficiency and venous stasis disease and that Petitioner initiated an on-going course of treatment. See, e.g., P. Ex. 10, at 3-15. However, on September 2, 1999, during the survey, Petitioner's staff completed a Post Skin Wound Summary that shows Resident 43 had developed a "pressure ulcer" on his left outer ankle. (17) P. Ex. 10, at 16. Staff indicated on the form that the ulcer resulted because Resident 43 was noncompliant and that the ulcer was unavoidable. Id. However, the only preventive intervention noted was to "keep opened areas of Spanko boots covered with duoderm" (an adhesive skin dressing used for the treatment of pressure sores). Id. No new preventive intervention was proposed to deal with Resident 43's noncompliance. A plan of care form for preventive skin care bears the following entry, dated September 3, 1999: "(k)eep Duoderm strips to inside of Spanko boots to cover holes [and to] prevent pressure @ all times." P. Ex. 10, at 25.

On August 12, 1999, Resident 43 was noted to be walking with a walker wearing his Spanko boots, but there is no note that he was "educated" or counseled about not wearing his Spanko boots while walking. P. Ex. 10, at 42. He was counseled about being noncompliant with his turn schedule and positioning on more than one occasion. See, e.g., P. Ex. 10, at 39, 41, 45. A Nurse's Note, dated August 16, 1999, records that Resident 43 was ambulating with the use of a walker wearing his Spanko boots and that he was awaiting delivery of orthopaedic shoes. There is no notation that Resident 43 was counseled regarding not walking in his Spanko boots. P. Ex. 10, at 40. A Nurse's Note, dated August 17, 1999, records that Resident 43's doctor ordered that the Spanko boots be discontinued and that the patient should wear socks and house slippers. P. Ex. 10, at 38. This evidence raises the issue of why Petitioner allowed Resident 43 to continue in the Spanko boots after he was known to be noncompliant and after the doctor ordered that they be discontinued. Had Petitioner promptly acted upon the noncompliance or the doctor's orders, the Spanko boots would not have caused the pressure sore. Resident 43 received his orthopaedic shoes September 1, 1999 (P. Ex. 10, at 32), but then could not wear them until September 13, 1999 because he had to wait for his family to bring him socks that fit (P. Ex. 10, at 19, 33).

Petitioner argues in its post-hearing brief that Resident 43 was at fault for the pressure sore on his left ankle because he was noncompliant by walking in his Spanko boots and was noncompliant with his diet. P. Brief at 16. In the alternative, Petitioner argues that Resident 43 had a venous stasis ulcer, not a pressure sore. Id. at 17. Petitioner's arguments are not persuasive.

Petitioner's staff recognized that the sore that developed on Resident 43's left ankle was a "pressure sore" and characterized it as such in Resident 43's treatment records. While staff characterized the sore as "unavoidable," the problem with the Spanko boots was resolved by the simple intervention of placing Duoderm tape over the hole in the Spanko boot where the sore occurred. P. Ex. 10, at 16. Furthermore, Resident 43's records show that his doctor had ordered the Spanko boots be discontinued as of August 17, 1999. The Resident should have been wearing slippers and socks at the time of the survey. I find no evidence in Resident 43's records that he was ever counseled or cautioned not to try to walk in his Spanko boots or that the facility dressed him in slippers and socks. The sore on Resident 43's ankle at the time of the survey could have been avoided had Resident 43 been placed in socks and slippers on August 17, 1999, or had tape been placed over the hole in the Spanko boot.

The allegations of the SOD are proved by Petitioner's own evidence. CMS has established a prima facie showing. Again, Petitioner failed to show that the pressure sore on Resident 43's ankle was unavoidable or that Resident 43 was properly treated to avoid development of new sores. I conclude that the example of Resident 43 also represents a violation of 42 C.F.R. § 483.25(c).

Example 3 - Resident 45 (CMS Ex. 1, at 40): The surveyors alleged that, while at the facility, Resident 45 developed a pressure sore on her coccyx that was first documented on May 31, 1999. On September 3, 1999, the surveyor, while observing treatment of the coccyx pressure sore, noted "a new Stage I area . . . on the right buttock deep purple in color." Staff verified for the surveyor that the only padding in the resident's chair was a layer of sheepskin and that there was no pressure relieving device. Petitioner responded in its plan of correction that Resident 45's coccyx pressure sore was healed by September 20, 1999; that the purple area observed by the surveyor on the buttocks was scar tissue from a previous wound; and that the resident was given a pressure relieving cushion for her chair. CMS Ex. 1, at 36.

Ms. Parks testified for Petitioner that, after the survey, she examined Resident 45 and found that the deep purple area alleged to be a Stage I ulcer was actually scar tissue from a previous sore. Tr. 513. This testimony is unrebutted and consistent with Resident 45's treatment record. See P. Ex. 27, at 5. Thus, I accept the testimony as credible.

CMS argues that Petitioner's records for Resident 45 show that she was not provided a pressure relieving device for her chair until September 3, 1999, despite the fact that she was at risk for developing pressure sores. CMS Post-Hearing Brief, at 4; CMS Ex. 46, at 5-12. CMS has failed to establish a prima facie case based on the allegation related to Resident 45. CMS does not allege that the formation of the ulcer on May 31, 1999 was the basis for the citation. Rather, the surveyors cited the formation of a new Stage I area on the right buttock on about September 3, 1999 and the failure to provide a chair pad for Resident 45's gerichair. Based on the testimony of Ms. Park, who examined Resident 45, and my own reading of the treatment records, the unrebutted evidence is that there was no new Stage I pressure sore on Resident 45's right buttock. Rather, the surveyor observed scar tissue from a prior sore. See P. Ex. 27, at 10-11. CMS has pointed to no doctor's order, care plan, (18) or other requirement that Resident 45 have a cushion in her gerichair, which she occupied only twice per day for an unspecified amount of time. Furthermore, Resident 45's treatment records reflect constant improvement in the coccyx pressure sore first identified in May 1999, and no new pressure sore at the time of the survey. Therefore, while a chair pad was probably a good idea, the evidence does not support the CMS allegation that Petitioner's failure to provide such a pad amounted to a failure to "furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32.

Example 4 - Resident 171 (CMS Ex. 1, at 40-41): The surveyors alleged that, while at the facility, Resident 171, who was totally dependent on staff, developed a Stage II pressure sore on the left ankle, and that the sore was preventable. The sore had not been discovered or recorded by the facility prior to the survey. Specifically, records show that Resident 171 had a healing right ankle fracture and a Stage II pressure sore on the upper thigh from the cast. When the surveyor observed the resident from 8:50 a.m. to 10:30 a.m. on August 31, 1999, Resident 171's right ankle was wrapped in an ace bandage and was resting on top of the left leg with no pressure relieving device between the legs. During treatment of the pressure sore on the thigh, the nurse found a "blister" on the "bony prominence of the left ankle" which was then appropriately treated. The resident was again observed on September 1, 1999 with feet and legs resting on the vinyl foot rest of a reclining chair with no pressure relieving device in use. Petitioner responded in its plan of correction that both the pressure sores on the hip and ankle had healed and that the resident's plan of care had been updated to include pressure relieving devices. CMS Ex. 1, at 36.

Ann Alden, a registered nurse and surveyor with the Ohio Department of Health, testified on behalf of CMS. Her education and experience are described in the record. Tr. 213-15. Ms. Alden participated in the survey of Petitioner which is the subject of this decision. Tr. 215-16. Ms. Alden made observations of Resident 171 which she recorded in CMS Ex. 31. Tr. 230-34. Her testimony is not inconsistent with her observations recorded in the SOD.

Ms. Parks testified for Petitioner regarding Resident 171. She confirmed the pressure sore on the thigh was caused by the resident's cast which had been removed. She also acknowledged that "a small blister" developed on Resident 171's ankle where her legs rubbed together as a result of uncontrollable movements of her legs due to Parkinson's disease. The blister healed in five or six days. Tr. 513-14.

A skin condition progress report completed by Petitioner's staff dated August 31, 1999, reflects that on that date Resident 171's left foot was assessed and on the outer lateral aspect of the left ankle there was a reddened area with an intact blister. The reddening decreased after pressure was relieved. "(B)lister probably caused by shearing on sheets . . . ." CMS Ex. 31, at 18. According to a Post Skin Wound Summary, dated September 1, 1999, preventive measures in place prior to the discovery of the blister were the use of a pressure relieving mattress, turning and repositioning every two hours, monitoring nutritional status, monitoring for infection, and monitoring for new areas. CMS Ex. 31, at 19.

The following facts are undisputed: 1) Resident 171 had a fracture of her lower right leg; 2) she developed a pressure sore behind her right knee or lower right thigh, due to abrasion from the cast (not an alleged deficiency); 3) eventually the cast was removed and replaced with an ace wrap; 4) due to her Parkinson's disease, the resident had constant movement of her legs; and 5) a blister developed on the lateral or outside aspect of Resident 171's left ankle that was observed by the surveyor. The testimony of Ms. Parks, that the blister was from the uncontrolled rubbing of the legs together, suggests that the blister was on the interior aspect of Resident 171's left ankle. This testimony is not credible, as it is inconsistent with the other evidence of record. Petitioner's argument in its brief seems to be based on this erroneous impression. See P. Brief, at 17. However, the Skin Condition Progress Report, completed by Petitioner's staff on August 31, 1999, clearly indicates the left foot "outer lateral aspect reddened with intact blister . . . probably caused by shearing on sheets." CMS Ex. 31, at 18. Ms. Alden's surveyor notes (CMS Ex. 31, at 4, 5) and her testimony (Tr. 234) are consistent with the blister being on the outside of the left ankle. Ms. Alden testified that when she observed Resident 171, she noted a posting above the resident's bed that required staff to turn the resident to her left side, back and then to her left side. Ms. Alden was concerned because the resident was often on her left side, causing pressure on the left ankle. Tr. 234. On cross-examination, she clarified her concern was that because the resident was always being turned to the left, she should have had some sort of protective device on the left ankle to minimize pressure. Tr. 250.

Based on the testimony of Ms. Alden and her surveyor notes, it is not clear to me why the SOD was drafted to allege that "(t)here was no pressure relieving device between the legs." CMS Ex. 1, at 41. Nevertheless, it is clear from the SOD that the surveyor's allegation is generally that a pressure sore developed on the left ankle due to the absence of a pressure relieving device and that there was the potential for further sores due to the absence of pressure relieving devices on the resident's heels while seated in her gerichair. Certainly, these allegations, though poorly drafted, were sufficient to place Petitioner on notice as to what to defend, particularly since Petitioner possessed the contemporaneous treatment records that revealed the true state of facts. Thus, I find no prejudice to Petitioner due to the faulty drafting of the SOD and none has been alleged.

Further, CMS has shown that Resident 171, who was admittedly at risk for the development of pressure sores, did develop a pressure sore on her left ankle. Thus, CMS has made a prima facie case. Petitioner has not shown that the pressure sore was unavoidable and it does not appear from the evidence of record that Petitioner had implemented any interventions to prevent the development of pressure sores even though it was obvious that Resident 171 was spending a significant amount of time resting on her left side and had nearly constant involuntary leg movements which caused friction with the bed sheets. I conclude that Petitioner did not take the steps reasonably necessary to avoid the development of new pressure sores. Therefore, the example of Resident 171 represents a violation of 42 C.F.R. § 483.25(c).

Example 5 - Resident 50 (CMS Ex. 1, at 41-43): Regarding Resident 50, the surveyors alleged that the resident's records reflected that he was assessed by the facility as being at risk for skin breakdown. On July 28, 1999, it was reported he had a three by two centimeter dark red area on the left hip. On August 20, 1999, it was reported that the resident had a Stage II pressure sore on the left hip of 1.8 by 3.4 centimeters with no drainage or odor. On August 30, 1999, it was documented that there was no change in the pressure sore. On September 3, 1999, it was documented that Resident 50 had a new pressure sore on the left hip (0.9 by 1 by 0.1 centimeters). (19) Care plan interventions included a wheel chair pad, repositioning every two hours, and incontinence care. On August 31, 1999, from 9:50 a.m. to 11:30 a.m., and on September 2, 1999 from 7:10 a.m. to 9:40 a.m., the surveyor observed Resident 50 restrained in his wheel chair without a pressure relieving device and no such device was later observed when Resident 50 was out of the chair. On September 1, 1999, the surveyor observed Resident 50 in his bed from 1:52 p.m. to 3:40 p.m. and, for an unspecified time, the surveyor noted the resident's brief and bed linen were wet and there was a strong urine odor. When two "agency nurse aides" changed Resident 50's brief and put on his pants, they failed to note or report that the dressing covering the pressure sore on the left hip had come loose and the wound had been contaminated with urine. Further, no pressure relieving device was placed in the wheel chair when Resident 50 was transferred to it.

Petitioner responded in its plan of correction: 1) that a pressure relieving device was placed in Resident 50's chair; 2) that the loose dressing was changed on September 2, 1999; 3) that treatment began for the second pressure sore on September 3, 1999; and 4) that both sores had improved. CMS Ex. 1, at 36-37.

Ms. Truett made the observations recorded in the SOD related to Resident 50. Tr. 62-73. (20) Her testimony does not conflict with her written observations, except that she clarified that Resident 50 was wet nearly the entire two hours she observed him on September 1, 1999. Tr. 70; CMS Ex. 52.

Ms. Parks testified for Petitioner regarding Resident 50. She noted that he had a history of being very agitated and combative. However, at the time of the hearing, Resident 50 was no longer combative or agitated, and his skin and general health had improved. She further stated that he had experienced no skin problems for about 18 months. Tr. 514-15. Ms. Parks did not specifically address the allegations in the SOD.

The facility records for Resident 50 presented by CMS are consistent with the observations in the SOD. CMS Ex. 50, at 3-7. The facility records offered by the Petitioner and admitted as P. Ex. 22, clearly show Resident 50 was combative and had numerous skin problems, including pressure sores. Facility records (P. Ex. 22, at 2-3; CMS Ex. 50, at 3-7) reflect that Resident 50 had developed the pressure sores as alleged by CMS and that Petitioner's Plan of Care for Preventive Skin Care required the use of chair pads and incontinence care according to the facility policy. P. Ex. 22, at 3.

Petitioner does not deny the allegations of the SOD but, rather, addresses the fact that, after the survey, Resident 50 significantly improved in all areas. P. Brief at 17. While the alleged improvement is laudable, it fails to address the alleged deficiency. Thus, I conclude that CMS has made a prima facie showing and Petitioner has failed to establish any defense to the specific allegations of the SOD. (21)

Example 6 - Resident 72 (CMS Ex. 1, at 43-44): The final example cited by CMS for this deficiency relates to Resident 72 who, it is undisputed, was in hospice care. Resident 72's records included an assessment of June 15, 1999, which reflected that the resident was incontinent of bowel and bladder, totally dependent on staff, and at risk for developing pressure sores. The assessment also showed that the resident had an 8 centimeter pink discolored area on the coccyx with a 0.6 by 0.4 centimeter open pressure area at its center. An August 30, 1999 Nurse's Note indicated possible improvement in the pressure sore, as it was recorded as being smaller. Resident 72's care plan required repositioning every two hours and checking and providing incontinence care every two hours. The surveyor observed Resident 72 on September 2, 1999 from 6:12 a.m. to 6:35 a.m., lying in bed on her back with her knees bent to her right. The surveyor observed incontinent care at 6:35 a.m. and noted a large amount of urine and dried feces. When incontinence care was completed, Resident 72 was returned to the same position she was in before the care. The surveyor reported that, from 6:35 a.m. to 9:42 a.m., Resident 72 was not repositioned, except that the head of her bed was elevated. The surveyor observed wound care on September 3, 1999, at 8:35 a.m. The staff nurse described the coccyx sore as Stage I, deep purple red in color. The purple red area was measured as 8 by 7.4 centimeters, with a 1 centimeter diameter open Stage II sore with a tunnel that was 0.6 centimeters deep, that was not previously identified or recorded.

Petitioner responded in its plan of correction: 1) that no tunneling was noted on October 24, 1999; 2) that there was a current order for hydrogel dressing; and 3) that the treatment goal for the resident is "palliative related to hospice status." CMS Ex. 1, at 37. This response does not deny or address the allegations of deficiency.

Ms. Truett also made the observation related to Resident 72. Tr. 73-79. See also, CMS Exs. 52, 53. Ms. Truett testified that, in her opinion, elevating the head of Resident 72's bed did not amount to repositioning of the resident and, in fact, had the effect of increasing pressure on the resident's "backside." Tr. 77. Facility records document that Resident 72 developed a new pressure sore during the survey. CMS Ex. 53, at 5-6.

Ms. Parks testified for Petitioner that, because Resident 72 was in hospice care, Petitioner's goal would be to provide palliative care, "not . . . to prevent or promote healing to a pressure ulcer." Tr. 508. She did point out that Resident 72, as most hospice care residents, did have an air mattress. Tr. 516. Further, she testified that Resident 72's end stage heart failure would have an effect upon her skin condition. Tr. 515-16. Ms. Parks did not explain why the facility was not following the plan of care for preventive skin care, which was initiated May 20, 1999 (while Resident 72 was considered a hospice patient) and which required incontinence care, turning every two hours, heel protectors, and repositioning every two hours while in a chair. P. Ex. 17, at 27.

Petitioner has not presented evidence that contradicts the observations of the surveyor, nor has Petitioner disputed that Resident 72 developed a new pressure sore nor that the existing sore worsened. (22)

CMS has made a prima facie showing regarding Resident 72 by presenting undisputed evidence of worsening of an existing pressure sore, development of a new sore, failure to provide timely incontinence care as evidenced by the presence of dried feces, and failure to turn the resident as witnessed by the surveyor. I find no authority, and Petitioner has cited none, for the proposition that, because Resident 72 was a hospice patient receiving only palliative care, it was unnecessary to either prevent or properly treat pressure sores. Petitioner has also failed to address why it did not follow the existing care plan for Resident 72, or why that care plan was not changed consistent with Petitioner's position that palliative care does not involve prevention and treatment of pressure sores. Petitioner has not argued that the worsening of existing sores or the development of new sores was clinically unavoidable.

In sum, regarding the alleged violation of 42 C.F.R. § 483.25(c), F Tag 314, Quality of Care (Pressure Sores), I conclude that CMS failed to establish a prima facie case regarding the example of Resident 45. However, CMS did establish a prima facie case regarding residents 168, 43, 171, 50, and 72, by showing the development of new pressure sores or the worsening of existing sores. Contrary to the general assertions of Petitioner, the evidence is thus not in equipoise. Rather, the burden is upon Petitioner to show that it went beyond merely what seemed reasonable and, instead, that it furnished what was necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed. Koester Pavilion, DAB No. 1750, at 32. As discussed above, Petitioner failed in each case to meet its burden by a preponderance of the evidence. Accordingly, I concur with the findings of deficiency and, based on the number of examples proven, find that a pattern has been established.

b. Petitioner violated 42 C.F.R. § 483.25(h)(2), F Tag 324, Quality of Care (Accidents).

The regulation at issue provides:

Sec. 483.25 Quality of care. 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.

(h) Accidents. The facility must ensure that-

* * *

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

The surveyors allege violation of this regulation due to one example of an elopement, four examples of falls, and one example of an improper use of a restraint.

In interpreting and applying 42 C.F.R. § 483.25, various panels of the DAB have been consistent in the opinion that providers are not strictly liable as insurers or unconditional guarantors of good outcomes in the delivery of services to nursing home residents. Rather, the quality of care provisions of section 483.25 impose an affirmative duty upon providers to deliver services designed to achieve the best possible outcomes to the highest practicable degree. Woodstock Care Center, DAB No. 1726, at 25; Asbury Center at Johnson City, DAB No. 1815. This interpretation is based upon the legislative history of the Act and on the regulations, which reflect that Congress and the Secretary chose to focus upon the desired ends or results of care rather than to impose rigid checklists of technical means, allowing facilities to meet the requirements for individual care in a variety of ways. See Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203; 54 Fed. Reg. 5,316 (1989) (the revisions focus on actual facility performance in meeting residents' needs in a safe and healthful environment, rather than on the capacity of the facility to provide appropriate services). Thus, the specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of section 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents.

Petitioner argues generally that the regulation is internally inconsistent and suggests it may be unenforceable because "[i]f a facility can prevent an accident then by definition what occurred was not an accident." P. Reply, at 3; see also P. Brief, at 21 n.6. Petitioner points out that "accident" is defined in the SOM as "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." P. Reply, at 3, citing SOM Appendix PP, Guidance to Surveyors, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995) (SOM Guidance). Petitioner's argument is without merit. The requirement of the regulation is that a facility will provide adequate supervision and assistive devices to prevent accidents, but prevention is by means of reducing or eliminating the risks that lead to accidents. It is not necessary that an accident actually occur for a violation to exist and the regulation is not contingent upon a resident suffering injury. A violation occurs when a facility simply fails to provide adequate supervision and assistive devices to eliminate or reduce the risk of an accident.

The issue is not whether the elopement or falls cited by CMS in this case were accidents, or even whether they resulted in injuries. The issue is whether the quality of the supervision or the use, or lack thereof, of assistive devices at Petitioner's facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. In order to evaluate a facility's compliance with section 483.25(h), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7, quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 and Koester Pavilion, DAB No. 1750, at 25-26. Section 483.25(h)(2) requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision or assistive devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. In Woodstock, the Board considered whether the facility had notice of or should reasonably have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27. In Osceola Nursing & Rehabilitation Care Center, DAB CR775 (2001), ALJ Montano found the facility knew of the resident's high risk for elopement and the risk for harm if the resident eloped and held the facility responsible for violation of section 483.25(h)(2). Based on the regulation and the cases in this area, CMS meets its burden to show a prima facie case if: (1) it presents evidence that an accident occurred (with or without harm to a resident); or (2) it shows the facility failed to do what it could to supervise residents or provide assistive devices to minimize risks that could lead to accidents.

CMS alleges in the SOD that Petitioner failed to "ensure residents received adequate supervision and assistance devices to prevent accidents" for six of 26 sampled residents and one of the six suffered an injury. CMS Ex. 1, at 53.

Example 1 - Resident 147 (CMS Ex. 1, at 53-54): CMS alleges that Resident 147, with a diagnosis of Alzheimer's disease and assessed with short and long-term memory impairment, periods of altered perception, and varied mental status, had a long history of elopement attempts from the facility. Petitioner's documents reflect, according to the surveyor, repeated elopement attempts, including July 18, 1999, when Resident 147 left through an unknown doorway and was found walking down the facility driveway; and on August 4, 6, and 10, 1999, instances when Resident 147 was found outside the facility and returned. CMS alleges that on August 30, 1999, the surveyor observed Resident 147 wandering outside the facility without staff supervision and nursing staff was unaware of Resident 147's exit. Resident 147's care plan provided that netted door guards were supposed to be on the outside doors of the facility but none were observed during the survey. The surveyor also noted that the door alarm made a loud piercing sound when activated and that when she entered the facility on September 2, 1999, she tripped the alarm, which was silenced without anyone coming to check to see who had tripped the alarm.

In its plan of correction dated October 24, 1999, which appears in the right column of the SOD, Petitioner states that "netted door guards were ordered for the appropriate doors on 9/15/99," which was after the survey. CMS Ex. 1, at 52. Petitioner did not specifically deny any allegation of the SOD.

Ms. Truett testified for CMS regarding Resident 147. She did a record review for the resident during the survey and, based on that review, she testified to Resident 147's diagnoses. Tr. 89-91. Ms. Truett recorded her observations in CMS Ex. 52. Ms. Truett also testified generally about elopements, the risks associated with elopements, and the means for reducing the incidence of elopements. Tr. 92-95. Ms. Truett testified that no netted door guards were in place on either the C or D wings during the survey. Tr. 93-94. Ms. Truett did not witness Resident 147 outside the facility on August 30, 1999. Tr. 95. Petitioner's counsel interposed a hearsay objection to Ms. Truett's description of the alleged elopement of August 30, 1999. Ms. Truett testified that another surveyor, Nancy Thompson, had described the incident to her. Tr. 96. CMS did not produce Ms. Thompson at hearing, but her notes are part of the record as CMS Ex. 44. The testimony was allowed but it was noted that the hearsay objection would impact upon the weight given the testimony. Tr. 96.

Petitioner offered, and I admitted as P. Ex. 8, some facility records related to the care and treatment of Resident 147. A psychiatry follow-up note dated July 23, 1999, includes a report of staff that the resident continues to wander and at times gets out the doors. P. Ex. 8, at 8. A post-elopement conference note, dated July 19, 1999, indicates that Resident 147 constantly wanders and is checked every 30 minutes but she was found in the driveway from the parking lot. Id. at 10. Resident 147 was unable to explain how or why she left the facility, due to dementia, and checks were changed to a frequency of every 15 minutes. Id. An Immediate Needs Care Plan, dated July 19, 1999, and also bearing dates of July 31, 1999 and August 30, 1999, indicates the goal that Resident 147 would not leave the facility without supervision, which would be accomplished by 15-minute checks, use of a watchmate (a personal alarm), redirection, and diversion, among other things. Id. at 12. An Interdisciplinary Plan of Care from 1998 indicates that Resident 147 wandered and tried to leave the building but never did so alone. Id. at 13. An Interdisciplinary Plan of Care with dates in 1999 notes that netted door guards are in place on the A and C wings, watchmate was in place, missing person protocol was in place, and frequent checks were required. Id. at 20. Netted door guards on wings A and C and watchmate are also noted in other care plan documents. See, e.g., P. Ex. 8, at 23, 25. A care plan entry dated July 1, 1999, indicates that 15-minute checks were initiated and Resident 147's whereabouts were to be noted on her flow sheet. Id. at 26. A July 19, 1999 entry notes that staff was to encourage her to sit in the nurses' station with staff and with the "half door" closed at all times. Id.

Ms. Beth Johnson testified on behalf of Petitioner regarding Resident 147. She indicated that netting was not present on the doors on the hallway where Resident 147 resided, as the doors had alarms and Resident 147 wore a watchmate. Tr. 467. She also testified that it was not possible to observe Resident 147 outside the facility from the location where Ms. Thompson allegedly observed her, as Resident 147 would have been in a fully-enclosed courtyard. Tr. 468. She further testified that on the day the surveyor tripped the alarm, she observed the surveyor and called to nursing staff to silence the alarm rather than have someone come check who tripped the alarm. Tr. 468-69.

It is disputed that Ms. Thompson actually saw Resident 147 outside the facility. Petitioner presented testimony that Ms. Thompson could only have seen Resident 147 in a fully-enclosed courtyard. Whether or not the courtyard was covered and protected from the elements or presented any other risks to a demented and confused resident are not facts in evidence. CMS has not made a prima facie showing that a demented resident's escape to an enclosed courtyard amounts to an elopement. Ms. Thompson was not present to testify; thus, her observations could not be expanded upon or tested. Ms. Truett's testimony regarding what Ms. Thompson told her about the alleged elopement of Resident 147 was no more detailed than the observations recorded in the SOD and Ms. Thompson's working notes (CMS Ex. 44). I give more weight to the testimony of Ms. Johnson than to the extra-record statements of Ms. Thompson. Accordingly, I conclude that CMS failed to make a prima facie showing that Resident 147 eloped on August 30, 1999.

I also accept Petitioner's evidence as persuasive on the alleged failure of staff to respond to a door alarm triggered by a surveyor during the survey. The testimony of Ms. Johnson on this point was unrebutted and she was credible on this point.

However, CMS did make a prima facie case that the netted door guards called for by Resident 147's plan of care were not in place during the survey. Petitioner's records establish the requirement for both netted door guards and a watchmate or wanderguard personal alarm. From Petitioner's records related to Resident 147, which were admitted as evidence, it is clear that: 1) Petitioner's staff was aware that Resident 147 was at risk to attempt to elope; 2) given her diagnosis and functional capacity, Resident 147 was at risk of physical harm if she left the confines of Petitioner's building without supervision; and 3) Resident 147 had been assessed, and Petitioner's staff had determined, that netted door guards were necessary to reduce or eliminate the risk of Resident 147 eloping. The fact that the doors in question also had an alarm system is not a defense to the extent that the care plan makes no distinction between doors with alarms and doors without alarms. In fact, because the care plan indicates Resident 147 could be redirected, the visual impact of the door nets may have been intended by the care planners to be an effective additional deterrent to Resident 147's wandering ways. The DAB has previously upheld deficiency findings under 42 C.F.R. § 483.25 based on a facility's failure to follow its plan of care since "[a] care plan is based on a facility's assessment of a resident's needs and represents an interdisciplinary team's best judgment of the services required for the resident, including services required under section 483.25." Coquina Center, DAB No.1860, at 21 (2002), citing Cherrywood Nursing and Living Center, DAB No. 1845, at 8 (2002); Crestview Parke Care Center, DAB No. 1836 (2002); Asbury Center at Johnson City, DAB No. 1815. Section 483.25 clearly requires that the facility provide care and services "in accordance with the comprehensive assessment and plan of care."

Example 2 - Resident 72 (CMS Ex. 1, at 54-55): It is alleged in the SOD that Resident 72 suffered from dementia and Alzheimer's disease, among other things. She was subject to being agitated and had been assessed on June 15, 1999 with short and long-term memory impairment and no decision-making ability. She was not ambulatory, dependent upon staff for all care, and at risk for falls. Resident 72's care plan specified the use of a pressure sensitive alarm on her bed to reduce the risk of falls. Facility records reviewed by the surveyor indicated that on August 9, 1999, Resident 72 tried to climb out of bed but was returned by staff. On August 22, 1999, Resident 72 was found lying on the floor with injuries after her restraint free alarm sounded. The surveyor recorded that Resident 72's records reflected that the alarm was the type that attached to the bed and was clipped to Resident 72's clothing; that at the time of the fall only one side-rail was up; and that Resident 72 rolled out of bed and onto the floor. It is alleged in the SOD that a doctor's order, dated August 22, 1999, discontinued the alarm and ordered the use of two side-rails "to define the bed parameters." The surveyor observed Resident 72 in bed on September 2, 1999, from 6:12 a.m. to 9:42 a.m. with no alarm device at all, but with three-quarter length side-rails up with wedge pads in place along the side-rails. The surveyor noted that the side-rails did not extend to the end of the bed. The surveyor alleged that Resident 72 had demonstrated trying to get out of bed and actually fell, but interventions were not in place to prevent recurrence.

Petitioner offered, and I admitted as P. Ex. 17, 40 pages of facility records related to Resident 72. Physician's Orders from April 21, 1999 indicate a bed alarm was to be used at all times to alert staff to unassisted transfers and ambulation, and that one side-rail was to be up while Resident 72 was in bed. P. Ex. 17, at 14. Petitioner's records reflect that the order for the alarm and one side-rail continued through May 30, 1999. Id. at 10. The alarm was deleted from the June 27, 1999 Physician's Order, but the side-rail continued with the note that it was to "aide in defining the bed parameters." Id. at 7. The bed alarm and side-rail were both listed in the orders of July 31, 1999. Id. at 4. The orders of September 1, 1999 reflect that the use of the bed alarm was discontinued on August 23 and the use of both side-rails was ordered. Id. at 1. An Interdisciplinary Plan of Care shows that Resident 72 was assessed as at risk for falls on June 15, 1999. Id. at 22. The plan of care also reflects that the use of a bed sensor alarm was discontinued August 23, 1999. Id. Nurse's Notes from July 30, 1999 indicate that Petitioner was using both side-rails to prevent falls because Resident 72 was unaware of her limitations. Id. at 40. On August 9, 1999, Resident 72 was anxious, calling out and tried to climb out of bed at least twice. Id. at 39. An August 14, 1999 note indicates that only one side-rail was being used to "aide in defining bed parameters." Id. at 33. During the evening of August 14 it is noted that Resident 72 was attempting to get out of bed - she said to meet someone. Id. Notes from August 21, 1999 indicate that only one side-rail was being used. Id. at 34. On August 22, 1999, the notes indicate that Resident 72 fell from bed activating her restraint free alarm and causing her injury. Id. The Initial Post Fall Assessment, dated August 23, 1999, for the fall of August 22, indicates that Resident 72 was in bed with one side-rail up; that she rolled out of bed on the side without the rail; that staff responded when the restraint free alarm sounded, but found Resident 72 on the floor with injuries. Id. at 17-21. The assessment also indicates that Resident 72's son was upset that both side-rails were not being used and that the facility will use both side-rails at family request. Id. at 21. On August 24, 1999, Nurse's Notes show that the facility began using both side-rails again. Id. at 35. Notes from August 27, 1999, indicate that the side-rails are padded. Notes from September 3, 1999, reflect that both side-rails were being used at family request to prevent falls. Id. at 37.

Ms. Truett testified for CMS regarding her observation related to Resident 72. Her notes from the survey were admitted as recorded in CMS Ex. 53. Ms. Truett testified that she reviewed Resident 72's records and made the findings cited in the SOD. Tr. 97. It was her understanding from the records that Resident 72 attempted to climb out of bed on multiple occasions and had fallen from bed and sustained injury on August 22, 1999. Tr. 97-98. Ms. Truett testified generally about the risk of injury related to falls and devices and methods to protect against falls and/or secondary injuries. Tr. 98-100. Ms. Truett explained the difference between a restraint free alarm and a pressure sensitive alarm - the restraint free alarm, such as that used on Resident 72 on August 22, 1999, involves a tether attached to the resident and to an alarm box so that when the resident moves a certain amount the tether pulls and activates the alarm. Tr. 99. The pressure sensitive alarm is generally more sensitive and is placed under the bedding so that when a resident moves a certain amount the alarm sounds. Id. According to Ms. Truett's unrebutted testimony, it takes less movement to set off the pressure alarm than the tether alarm. Therefore, use of the pressure alarm may allow staff more time to respond before the resident actually hits the floor. Tr. 103. Neither type alarm requires that a doctor order its use; a facility may choose to implement an alarm on its own initiative. Tr. 99-100. Ms. Truett also testified about side-rails and their use. Ms. Truett pointed out that residents can climb over or around side-rails depending upon their length; that there is a risk of harm inherent in the use of side-rails (Tr. 100-01); and she admitted on cross-examination that side-rails are a form of restraint that, by regulation, must be used to the minimum possible extent (Tr. 193).

Ms. Truett testified regarding Resident 72 that her plan of care required a "pressure sensor alarm" or "bed alarm" when Resident 72 was in bed. Tr. 101. At the time of the survey, Petitioner was using two three-quarter length side-rails with pads, but no bed alarm of any kind. Id. Ms. Truett testified that she was concerned, given Resident 72's history of trying to climb out of bed, that discontinuing the alarm and the three-quarter length side-rails might result in another fall. Tr. 102. Regarding the fall on August 22, 1999, Ms. Truett testified that, in her opinion, the facility's efforts to prevent falls were insufficient because only one side-rail was in use, which left the other side of the bed open. Id. She also noted that the use of a single side-rail may have confused Resident 72 and increased her risk of falling, since, according to Petitioner's records, both side-rails had been used in the past. Tr. 103. Ms. Truett opined that the use of a pressure sensor or bed alarm rather than a restraint free or tether alarm might have alerted staff prior to Resident 72 actually falling from bed on August 22, 1999. Tr. 103.

Ms. Beth Johnson testified on behalf of Petitioner regarding Resident 72. According to Ms. Johnson, the facility used the least restrictive method of restraint, by employing one side-rail and an alarm. Tr. 469. After Resident 72 fell, the facility implemented use of two side-rails, which was effective. Id. She further testified that the side-rails used left 20 inches between the end of the rails and the end of the bed and that was not enough space for Resident 72 to "come out from the end of that rail." Tr. 470. Ms. Johnson admitted on cross-examination that Resident 72 was restless and had a tendency to move around in her bed, but her ability to move or scoot around in bed was limited. Tr. 491-92.

CMS argues in its post-hearing brief that Petitioner failed to use a pressure sensitive alarm in Resident 72's bed and used only three-quarter length bed rails which were too short. CMS Brief, at 8. In its reply brief, CMS argues that, at the time of the survey, the side-rails left 20 inches of the bed unprotected; that Resident 72 could scoot up and down in her bed; and that Petitioner was not using a pressure sensitive alarm. CMS Reply, at 8.

Petitioner argues in its post-hearing brief that it complied with the regulatory requirement for progressive implementation of restraints, going from a single side-rail with an alarm to double side-rails, which was effective. Petitioner emphasizes that the only unprotected part of the bed was the lower 20 inches, from Resident 72's knees to the end of the bed. P. Brief, at 20-21.

My reading of the SOD is that CMS alleges Petitioner was deficient on August 22, 1999, when Resident 72 rolled out of bed, through the survey and after. CMS alleges that Petitioner was deficient on August 22, 1999 because only one side-rail was in use and a tether or restraint free alarm was in use rather than a bed alarm or pressure sensitive alarm, as ordered by Resident 72's doctor. CMS alleges Petitioner continued to be deficient at the time of the survey because no alarm was in use and the side-rails in use were too short to prevent Resident 72 from falling out of bed.

I consider first the fall on August 22, 1999. Ms. Truett asserts in her testimony that there is a difference between the tether alarm in use on Resident 72 on August 22, 1999, and the bed alarm or pressure sensitive alarm ordered by Resident 72's doctor. She testified that the use of the pressure sensitive alarm might have alerted staff before Resident 72 actually fell from her bed. Ms. Truett's testimony regarding the alarms has not been disputed. Petitioner has never alleged that a pressure sensitive bed alarm was used with Resident 72. The failure to use a pressure sensitive bed alarm violates the order of Resident 72's doctor. Regarding side-rails, the doctor's orders of record clearly indicate that only one side-rail was deemed necessary by the doctor during the period April 21, 1999 to August 23, 1999. (23) Surprisingly, Resident 72's interdisciplinary plan of care offered as evidence makes no specific reference to the use of side-rails despite the existence of the doctor's orders. (24) Nurse's Notes from 2:25 p.m. on July 30, 1999, (25) indicate that Petitioner was using both side-rails to prevent Resident 72 from falling from bed because Resident 72 was unaware of her limitations. P. Ex. 17, at 40. Notes from 10:00 p.m. on July 30, 1999 also reflect that two side-rails were in use. Nurse's Notes from 2:05 a.m. on July 31, 1999 show that only one side-rail was in use. Id. There is no explanation for why the use of two side-rails was discontinued the morning of July 31, 1999. Id. On August 9, 1999, Resident 72 was anxious, calling out, and tried to climb out of bed at least twice. Id. at 39. There is no indication that any alarm sounded. An August 14, 1999 note indicates that only one side-rail was being used to "aide in defining bed parameters." Id. at 33. During the evening of August 14 it is noted that Resident 72 was attempting to get out of bed - she said to meet someone. Id. There is no indication an alarm sounded. She also attempted to get out of bed on August 15, 1999. Id. Again, there is no indication an alarm sounded. Notes from August 20 and 21, 1999, indicate that only one side-rail was being used, but without injury. Id. at 33-34. Resident 72 then fell out of bed on August 22, 1999.

CMS has made a prima facie showing that Petitioner was deficient with regard to the fall of August 22, 1999. Resident 72 was assessed by Petitioner to be at risk for falls. The resident made several attempts to climb out of bed, apparently without causing her alarm to sound. I infer from the fact that she rolled out of bed on the side without the side-rail up that that side of the bed was not against the wall or otherwise blocked. This inference is further supported by the fact that Resident 72 fell completely out of the bed. Clearly, Petitioner should have known there was a risk that Resident 72 was eventually going to fall from bed, given that: 1) she repeatedly tried to get out of bed; 2) the restraint free alarm apparently failed to sound when she attempted to get out of bed; (26) 3) the type of alarm specified by the doctor was not used; and 4) on at least one day in July, Petitioner's staff found it necessary to use two side-rails to keep Resident 72 from falling from bed. It is not disputed that Petitioner's records reflect that Resident 72 was injured as a result of her fall on August 22, 1999.

Petitioner's assertion that it was using progressive restraint does not answer the question of whether it was doing all that was reasonable to prevent Resident 72 from falling from bed. Certainly a facility has a duty to use as little restraint as possible, but it also has a duty to protect its residents from harm. A provider is obliged to fulfill both duties. That requires a careful balancing of the amount of restraint in light of the potential risk for harm if restraint is not used. However, it is no defense for Petitioner to allege that it failed in its duty to protect a resident from harm because it was fulfilling the duty to use only minimum restraint. Rather, in this case, Petitioner needed to demonstrate that it took reasonable measures to prevent or eliminate the risk of Resident 72 falling. To the extent that Petitioner used restraints as the means to minimize the risk of falls, Petitioner had the duty to use the minimum restraint necessary to meet the goal of minimizing or eliminating the risk. In this case, it may have been reasonable for Petitioner to use a single side-rail and a pressure sensitive alarm, as ordered by Resident 72's doctor, but that was not done. Resident 72's increased attempts to get out of bed without sounding her alarm surely demonstrated the ineffectiveness of the tether alarm and the single side-rail. Perhaps the use of two side-rails and the tether alarm, as done on July 30, 1999, was reasonable, but that was discontinued on July 31, 1999. Petitioner has not shown that it took reasonable measures to eliminate the risk of Resident 72 falling, thereafter.

After Resident 72's fall on August 22, 1999, Petitioner discontinued the tether alarm and began using two side-rails. The alarm was apparently discontinued per order of Resident 72's doctor. CMS alleges that Petitioner nevertheless remained deficient, as Resident 72 remained at risk for scooting around in bed and falling through the 20-inch gap between the end of the three-quarter length side-rail and the footboard of the bed. Petitioner's witness, Ms. Park, admitted that Resident 72 was capable of scooting around in bed. I conclude that Petitioner remained deficient even after initiating use of two side-rails. If Resident 72 could scoot around in bed, as Ms. Park admitted, and given Resident 72's past efforts to climb out of bed, then the risk remained that Resident 72 could fall head first or feet first through the gap left by the side-rail. There was also a risk of entrapment if Resident 72 tried to climb through that gap. Reasonable approaches by Petitioner included using a full-length side-rail or three-quarter length side-rails with a pressure sensitive alarm or any of a number of other approaches, such as placing the resident's bed on the floor or a minimal distance above the floor with mats. I conclude that Petitioner did not take reasonable measures to reduce the risk that Resident 72 would fall.

Example 3 - Resident 6 (CMS Ex. 1, at 55-56): CMS alleges in the SOD that Petitioner was deficient with respect to Resident 6, who had a history of falls, because his care-planned pressure sensitive bed alarm was not being used and because there was a hole in the floor mat by his bed. The surveyor records observing Resident 6 on August 31, 1999 at 10:38 a.m. and at 6:25 p.m. and, on both occasions, Resident 6 was in bed with no staff present and his bed alarm was not turned on. The surveyor observed the mat by Resident 6's bed on August 30, 31, and September 1, 1999, and noted a U-shaped piece was missing, leaving a raised jagged area which she believed constituted a trip hazard. The surveyor reviewed facility records and cited evidence of at least six falls, at least one of which was from bed. The surveyor alleged that the care plan provided for no interventions to prevent falls from bed, except the bed alarm.

Ms. Dunn, the surveyor who observed Resident 6, testified on behalf of CMS. Her notes from the survey were admitted as CMS Ex. 25. Ms. Dunn testified that she twice observed Resident 6 in bed without his pressure sensitive bed alarm functioning. Tr. 318- 19. She testified that the mat next to Resident 6's bed had a small chunk missing and she later clarified it was a two inch chunk and she believed it was a trip hazard. Tr. 319-20. Ms. Dunn's testimony was consistent with the allegations contained in the SOD.

Beth Johnson testified for Petitioner that the mat with the missing chunk created no more of a trip hazard than the mat itself. Tr. 470-71. I admitted 48 pages of facility records for Resident 6, as P. Ex. 28. A bed alarm is required by Resident 6's plan of care. P. Ex. 28, at 9, 14, 19.

CMS argues in its post-hearing briefs that the deficiency citation was based on two observations: 1) that Resident 6's bed alarm was not functioning on two occasions on August 31, 1999; and 2) that there was a piece missing from the floor mat. CMS Brief, at 8; CMS Reply, at 8. Petitioner argues that the floor mat did not present a trip hazard; that on August 5, 1999, Resident 6 fell from his wheelchair and that fall had nothing to do with the mat; and that there were numerous interventions in place to prevent Resident 6 from falling. P. Brief, at 22.

There is no dispute that Resident 6 was at risk for falls from his bed and had a history of falling from his bed. It is not disputed that Resident 6's care plan required the use of a pressure sensitive bed alarm to help prevent falls. Petitioner never addresses, and it is not disputed, that twice on August 31, 1999, Ms. Dunn observed that Resident 6's pressure sensitive bed alarm was not functioning. Accordingly, with regard to the bed alarm, I conclude that CMS made a prima facie showing of a deficiency, and that Petitioner has failed to establish any defense.

Regarding the rubber mat, I conclude that CMS has failed to make a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2). The issue under this regulatory provision is whether Resident 6 was at risk for accidental injury and not whether others were at risk. There is no indication that Resident 6 could walk or that the missing piece of the mat interfered with his safe use of his wheelchair. I also have no clear description of how much of the mat was actually missing.

Example 4 - Resident 14 (CMS Ex. 1, at 56-57): It is alleged in the SOD that Resident 14's plan of care specified that he was to have a restraint free alarm at all times, bed side-rails, and a rubber bedside mat. On August 31, 1999, the surveyor observed Resident 14 in bed with the three-quarter side-rails up, but Resident 14 had his legs sticking out of the gap between the end of the side-rail and the footboard, on the side of the bed with no rubber mat, and his restraint free alarm was not sounding. On September 1, 1999, the surveyor observed Resident 14 in bed with the side-rails up, but his alarm was not turned on or was not functioning. Later the same day, the surveyor observed that Resident 14 had scooted down the bed with one foot over the bed footboard and the other foot sticking through the gap between the end of the side-rail and the footboard. Staff confirmed that the alarm was not on or was not functioning. The surveyor alleged that Resident 14 had a history of falls, that Petitioner had not implemented planned interventions, and that Petitioner failed to assess whether interventions were implemented.

Sharon Dunn testified regarding her observations as the surveyor who reviewed the situation with Resident 14. Her surveyor working papers were admitted as CMS Ex. 26 and they are not inconsistent with her testimony. She testified that she observed Resident 14 on August 31, 1999, on his bed with both three-quarter side-rails up, with his legs sticking out the end of the bed on the side away from the floor mat, and his alarm was not sounding. Tr. 323. She opined that Petitioner was not following Resident 14's care plan. Tr. 324.

Beth Johnson testified for Petitioner that Resident 14 was continually restless, trying to get into or out of bed. Fall interventions included a bed alarm, side-rails, and a bedside mat. Tr. 472. She testified that the interventions were effective. Id.

Petitioner submitted, and I admitted, P. Ex. 29, 45 pages of Petitioner's records for Resident 14. An Immediate Need Care Plan, dated March 2, 1999, reflects that Resident 14 was found on the floor by his bed with injury and that it was difficult to use a restraint free alarm because he would not keep his clothes on. P. Ex. 29, at 4. An Immediate Need Care Plan, dated March 22, 1999, shows that Resident 14 fell out of bed when his side-rails were not up. Id. at 2. A Social Progress Note, from March 25, 1999, indicates that Resident 14's restraint free alarm was discontinued because he did not like to wear clothing and there was nothing to which to attach the alarm. Id. at 28. A plan of care form with dates of May 31, 1999, August 31, 1999, November 24, 1999, and November 30, 1999, indicates that bilateral bed side-rails continued to be used to define bed parameters. Id. at 33. Nurse's Notes from July 8, 1999, show that Resident 14 fell and undated notes on the same exhibit indicate that Resident 14 was found, partly on and partly off the bed, trying to get out of bed. Id. at 39. Nurse's Notes from August 1, 1999, show that Resident 14 was found on the floor having fallen from bed after climbing past the bottom of the side-rail. Id. at 34-35. The post-fall assessment for the August 1, 1999 fall indicates that a rubber mat would be placed at bedside. Id. at 7. An Immediate Need Care Plan, dated August 1, 1999, establishes the goal that Resident 14 will not climb out of bed and fall. Id. at 1. The care plan lists as interventions that staff should encourage Resident 14 not to climb out of bed and to use the call light. Id. Social Progress Notes from August 9, 1999 indicate that Resident 14 was restless, trying to climb out of bed; that Resident 14 could not be educated due to cognitive losses; and that the plan of care was in place. Id. at 26. On August 12, 1999, Resident 14 was found lying across the bottom of his bed with his feet on the floor with his belly on the bottom of the bed and head up in the air. Id. at 43. On August 17, 1999, Resident 14 was found with his knees on the floor and his arms across the bed. Id. at 42. A Post Fall Assessment Update, dated August 18, 1999, indicates that Resident 14 climbed out "below" his side-rail. Id. at 11. I take the word "below" to mean he crawled through the gap between the end of the side-rail and footboard, based on the noted plan that staff was going to try to reposition the side-rails "lower" on the bed. See id. at 12. This interpretation is reinforced by Beth Johnson's testimony that the side-rails were moved down on the bed. Tr. 477. On August 18, 1999, Resident 14 was found trying to climb out of bed and a "bed alarm (was) applied to (the) bed." Id. at 42. Nurse's Notes from August 19, 1999, show that Resident 14 was non-compliant with the use of his call light and was found trying to crawl out of bed several times "posing threat of injury to self . . . noninvasive bed alarm has been applied to keep staff aware . . . ." Id. Notes from August 20, 1999 reflect that the bed alarm was in place and that it goes off at times. Id. On August 21, 1999, Resident 14 tried to get out of bed and staff reminded him that he could be injured. Id. at 44. On August 29, 1999, Resident 14 again attempted to get out of bed and was reminded by staff that he might injure himself. Id. at 45. On September 5, 1999, Resident 14 was found half in and half out of bed. Id. On September 16, 1999, Resident 14 was again found out of bed after a delayed alarm by the bed sensor alarm. Id. at 17. Resident 14 fell from bed again on September 18, 1999. Id. at 19. An interdisciplinary plan of care dated September 29, 1999 shows that Resident 14 was assessed as at risk for injury from falls due to a lack of safety awareness and agitation with several interventions listed including keeping both side-rails up (27) and "bilateral" bedside rubber mats. Id. at 31. On October 26, 1999, Resident 14 rolled from his low bed, prompting Petitioner to place bolsters on the low bed. Id. at 20-21.

CMS argues that Petitioner failed to adhere to its March 1, 1999 care plan addressing Resident 14's risk for falls. See, CMS Ex. 1, at 56. CMS offered no evidence, either through testimony or documents, to establish that there was a March 1, 1999 care plan for Resident 14 addressing his risk for falls. The records offered by Petitioner related to Resident 14 are obviously incomplete and contain no March 1, 1999 care plan for Resident 14. Nevertheless, based on the foregoing summary of the evidence, I conclude that CMS has made a prima facie showing of a violation of the regulatory requirement to provide adequate supervision and assistive devices for Resident 14. Clearly, Petitioner knew of the risk that Resident 14 was going to attempt to get out of bed, fall and injure himself at least as early as March 2, 1999, when he was found injured on the floor by his bed. It was also clear on March 2 that a restraint free alarm was not going to be effective, as Resident 14 would not wear clothes to which the alarm could be attached. Resident 14 was able to climb out of bed repeatedly, in spite of the presence of three-quarter side-rails. His ability to do so demonstrated the ineffectiveness of those side-rails, and the need for longer side-rails. The implementation of the floor mat was warranted, but it defies logic and common sense that a mat was only placed on one side of the bed, when the evidence shows that Resident 14 was equally adept at exiting the bed from either side. The fact that Resident 14 did not sustain more injuries is fortuitous and does not show, as Petitioner asserts, that its interventions were effective.

Petitioner alleged in its plan of correction that Resident 14 was given full side-rails and that a bed alarm was in use, but no date is indicated for implementation. CMS Ex. 1, at 53. The facility records admitted at hearing do not show that full side-rails were ever used for Resident 14. However, the records do show that Petitioner implemented use of bilateral bedside mats sometime around the September 29, 1999 assessment. See P. Ex. 29, at 31. The records also demonstrate that, at some time prior to the October 26, 1999 fall, Petitioner switched Resident 14 to a low bed, to which Petitioner apparently added bolsters at some time after October 28, 1999. See P. Ex. 29, at 20-21.

None of Petitioner's interventions, individually or collectively, were a reasonable response to the risk that Resident 14 was going to climb or crawl out of bed and injure himself, until he was placed on a low bed with bolsters. Petitioner's argument that Resident 14 was "continually restless, moving from one place to another either to get out of bed or into bed" (P. Brief, at 22) is not a defense but rather highlights that Petitioner was aware of the risk of accidental injury to Resident 14. The argument that the interventions were effective because there was no recorded fall from March 1999 to August 1999, flies in the face of Petitioner's own evidence, which clearly shows that Resident 14 tried to climb out of bed at least eight times in July and August 1999, exposing him to the risk of accidental injury.

Example 5 - Resident 163 (CMS Ex. 1, at 57-58): The surveyors allege in the SOD that Resident 163 was supposed to have a restraint free alarm attached to him when he was sitting in his wheelchair, as he had a history of leaning forward in the chair and falling. It is further alleged that, on August 31, 1999, a surveyor observed Resident 163 at various times between 10:08 a.m. and 10:23 a.m. without his restraint free alarm attached and without supervision. The surveyors do note that the resident was observed at other times during the survey with the restraint free alarm attached and sounding because he had leaned forward in his wheelchair.

Sharon Dunn, the surveyor who made the observations of Resident 163, testified for CMS and her notes were admitted as CMS Exs. 23, at 4; 29, at 14-15. Ms. Dunn testified that, on August 31, 1999, she saw Resident 163 sitting in his wheelchair, but that the clip and tether for his restraint free alarm was not attached to his clothing. Tr. 329. She also reviewed Resident 163's plan of care and found that the alarm was not mentioned, although staff confirmed that the alarm was necessary, as Resident 163 leaned forward in his wheelchair, creating the risk of falling. Tr. 329-30. On several other occasions, Ms. Dunn observed that Resident 163 did trigger his alarm by leaning forward. Tr. 330.

Facility records related to Resident 163 were admitted as P. Ex. 9. An Immediate Need Care Plan, dated November 6, 1998, specifies that a restraint free alarm was to be used when Resident 163 was in a wheelchair. Id. at 9. Interdisciplinary Progress Notes from conferences on May 27, 1999 and August 17, 1999 record that Resident 163 required a restraint free alarm when up in his wheelchair. Id. at 17, 20. An Immediate Needs Care Plan, dated September 6, 1999, specifies the use of a restraint free alarm but does not specify when it is to be used. Id. at 8. An Interdisciplinary Plan of Care for Resident 163, dated September 29, 1999, requires the use of a restraint free alarm while the resident is in a wheelchair. Id. at 15-16. A lap buddy (a restraint used in wheelchairs) was initiated on October 26, 1999. Id. at 6.

Beth Johnson testified for Petitioner regarding Resident 163. Ms. Johnson acknowledged that Resident 163 had a restraint free alarm due to the fact that he would lean forward and fall out of his wheelchair. She noted that the use of the alarm was effective to prevent falls. Tr. 473. Ms. Johnson testified that Resident 163's care plan did not specify that he required continual supervision and that, on the occasions the surveyor observed him without his alarm attached, he was on a supervised common hallway at a time with much traffic. She noted that Resident 163 had not had a fall in the two months prior to the survey. Tr. 474-75.

CMS argues simply that Resident 163 required a restraint free alarm when up in his wheelchair to alert staff before he fell. CMS Brief, at 9; CMS Reply, at 9. Petitioner does not deny that Resident 163's alarm was not attached to him when he was observed by the surveyor. Rather, Petitioner notes that the alarm had been an effective measure and that, when observed by the surveyors, Resident 163 did not need continual supervision and the hallway would have been filled with staff traffic. P. Brief, at 22.

CMS has made a prima facie showing of a deficiency. Petitioner's records reflect that, as early as November 1998, Resident 163 was assessed as at risk for falling forward from his wheelchair and that a restraint free alarm was required to minimize or eliminate the risk. Petitioner's records reflect that there was no change in the assessment and requirement for an alarm on August 17, 1999, just a few days prior to the survey at issue. It is undisputed the restraint free alarm had been an effective means to alert staff when Resident 163 leaned forward, which effectively prevented falls from his wheelchair. In fact, the surveyor acknowledged that she heard the alarm sound on other occasions when Resident 163 leaned forward. It is also not disputed that Resident 163's restraint free alarm was not attached on August 31, 1999, when surveyor Dunn observed him in his wheelchair in the hall. Petitioner never alleges that Resident 163 was under adequate supervision to prevent falls at the time his alarm was not connected. Petitioner fails to provide any evidence that the known risk of falls was minimized or eliminated by other means. Rather, Petitioner asserts that Resident 163 did not require continual supervision, that the hallway would have been filled with staff traffic, and that Resident 163 had not fallen for over two months. None of Petitioner's arguments address what Petitioner had done to minimize or eliminate the known risk that Resident 163 would topple head first out of his wheelchair absent his alarm. Thus, Petitioner has neither rebutted the CMS prima facie showing, nor established an affirmative defense.

Example 6 - Resident 60 (CMS Ex. 1, at 58-59): This example involves the use of a restraint in a manner that CMS alleges could cause injury. CMS alleges in the SOD that Resident 60 was totally dependent on staff and was cognitively impaired, due to dementia. On August 31, 1999, at 2:30 p.m., two surveyors observed the resident transferred from her wheelchair to her bed. At 3:15 p.m., the surveyors again observed Resident 60, this time in her bed, agitated and yelling with both her legs over her full length bed side-rails. The head of the resident's bed was elevated and a restraint was across her chest and attached to a non-moveable part of the bed. Staff did not respond until one surveyor activated the call light. CMS alleges that the manufacturer's instructions for the restraint specify that it should be attached to the moveable part of the bed to avoid injury, and that Petitioner did not provide adequate supervision to Resident 60 while she was restrained.

Debbie Truett testified for CMS that, on August 31, 1999, at 3:15 p.m., she and Sharon Dunn entered Resident 60's room. Tr. 104. They found Resident 60 in bed, agitated, yelling, her legs over the side rails, with no alarm. There was also a roll-belt type restraint over Resident 60's chest. Id. The roll-belt was tied to the bottom part of the bed frame, which does not move as the bed is elevated or lowered. Id. Ms. Dunn opined that the roll-belt was improperly applied because it was above Resident 60's waist, it was tied to a non-moveable part of the bed, and Resident 60 was very agitated. Tr. 105. Ms. Dunn testified that the restraint should have been tied to a moveable part of the bed and across Resident 60's waist. Tr. 106. She testified that her concern about the improperly placed restraint was that it would tighten across Resident 60's chest as the head of the bed elevated. Tr. 106. Alternatively, when the head of the bed was lowered, the restraint could loosen to the point where Resident 60 would be free to try to get out of bed and be injured. Id. Ms. Truett's notes related to her observation of Resident 60 were admitted as CMS Ex. 52, at 3.

Ms. Ann Alden, a registered nurse and surveyor who participated in the survey in question, also testified for CMS. Ms. Alden testified that she did a record review and observed Resident 60. Tr. 217-18. Ms. Alden's notes from the survey were admitted as CMS Exs. 33 and 34. Ms. Alden also testified that she observed Resident 60 in her bed on August 31, 1999, that Resident 60 was agitated, yelling out, with her feet against the side rails, and Resident 60 was in a lap restraint which was fastened to a non-moveable part of the bed. Tr. 18-19. Ms. Alden opined that the lap restraint should only be fastened to the moveable part of the bed. Tr. 219. (28)

Petitioner presented few records for Resident 60. However, Nurse's Notes from August 28, 1999, indicate that both side-rails and a roll-belt were in use while Resident 60 was in bed. P. Ex. 20, at 8. On September 1, 1999, the use of side-rails and a roll-belt were discontinued when Resident 60 was moved to a low bed and a restraint free alarm was initiated. Id.

Beth Johnson testified for Petitioner that she was familiar with Resident 60 and had reviewed her records. Tr. 475. Resident 60 had full side-rails and a roll-belt. Tr. 475-76. She opined that the manufacturer of the roll-belt recommended that it be tied so that the belt does not slide, i.e., so that the resident can roll side to side but not slide up and down in bed. Tr. 476. She further testified that Resident 60 could not call for help as all she could say was, "baa, baa, baa," which she did continually. Id. Ms. Johnson admitted on cross-examination that a roll-belt attached to a non-moveable part of the bed could cause injury to a resident, but she indicated that Resident 60 was so small that it probably would not cause injury to her. Tr. 485-86. Ms. Johnson also agreed that a roll-belt is not supposed to be around the chest, but she opined that Resident 60 may have slid down under the belt. Tr. 486-87. Ms. Johnson clarified, in response to my questions, that the roll-belt should not have been attached to the non-moveable part of the bed, but she disagreed with the statement in the SOD that the roll-belt should have been attached so that it could slide. Tr. 497-98. Ms. Johnson testified on redirect examination that restraints are checked every two hours per facility policy. Tr. 498-99.

There is no dispute among the three nurses who testified that the roll-belt was improperly applied to Resident 60 on August 31, 1999 at around 3:15 p.m., because it was attached to a non-moveable part of the bed. Further, there was a risk of injury due to the improper application of the restraint, even though, as Ms. Johnson testified, Resident 60 was so small that it probably would not have hurt her. No member of Petitioner's staff responded to Resident 60's yelling, and staff did not discover the improperly applied restraint until the surveyors brought it to staff's attention. These facts are sufficient to establish a prima facie case that a deficiency existed in the treatment of Resident 60. Petitioner has failed to show it took reasonable steps to eliminate or minimize the risk of injury in this case. The fact that Petitioner's policy required checking and releasing restraints every two hours is inadequate, given the fact that it takes but a few minutes to suffocate. The credibility of the surveyors is not negated by Petitioner's argument that Resident 60 could not speak. The surveyors' notes do not record that Resident 60 was yelling anything in particular, and the surveyors did not allege she said anything in particular, only that she was yelling. Petitioner's witness confirmed that Resident 60 could in fact yell "baa, baa, baa," which she did continually.

In sum, CMS alleges that Petitioner failed to ensure each resident received adequate supervision and assistance devices to prevent accidents, thereby violating 42 C.F.R. § 483.25(h)(2). CMS cites one example of an elopement, four examples of falls, and one example of an improper use of a restraint, in support of its conclusion. My review of the evidence leads me to conclude that Petitioner was deficient. As previously discussed, in each of the six examples, Petitioner either knew or reasonably should have known that the residents were at risk of accidents, but Petitioner failed to take reasonable measures to reduce or eliminate the risk of accidental injury. Actual harm has been shown with respect to Resident 72's fall on August 22, 1999, a single isolated incident. Each of the other examples reflects the potential for more than minimal harm without actual injury.

2. Petitioner was not in substantial compliance from September 3, 1999 through October 23, 1999.

In this case, CMS alleges that Petitioner was not in substantial compliance from September 3, 1999 through October 23, 1999, the day before the date on which the State agency determined that Petitioner had achieved substantial compliance. Petitioner denies that it was deficient in any of the areas cited by CMS and does not allege that it achieved substantial compliance prior to October 24, 1999.

This DAB has consistently rejected the idea that CMS must provide affirmative evidence of continuing noncompliance for each day that a remedy is in place. The Board has found that there is a presumption created by the regulatory scheme that once a deficiency is found that has the potential for more than minimal harm, the deficiency is continuing until such time as a resurvey shows that substantial compliance has been achieved, whether as of the date of that resurvey or an earlier date as determined by CMS. See Coquina Center, DAB No.1860, at 23, citing Regency Gardens Nursing Center, DAB No. 1858 (2002); Barn Hill Care Center, DAB No. 1848, at 14 (2002); Careplex of Silver Spring, DAB No. 1683 (1999); Lake City Extended Care Center, DAB No. 1658, at 12-13 (1998).

Petitioner has not specifically argued that substantial compliance was achieved before October 24, 1999. Furthermore, the foregoing discussion of deficiencies indicates that there is evidence that Petitioner did not achieve substantial compliance prior to September 9, 1999 and the period of noncompliance may have extended to October 26, 1999. Because the period of substantial noncompliance has not been placed in issue other than by Petitioner's denials, I conclude, having found deficiencies existed, that it is not necessary or appropriate to change the dates of the period of noncompliance.

3. A CMP of $650 for each day of substantial noncompliance is reasonable in this case.

Petitioner raised the issue of the reasonableness of the CMP proposed by CMS by asserting in its request for hearing and pre-hearing brief that it did not have the ability to pay. However, Petitioner presented no evidence on this issue at hearing and has not reasserted the issue in either of its post-hearing briefs.

It is well-established that there is a presumption that CMS considered the factors identified at 42 C.F.R. § 488.438(f) in determining the amount of the CMP imposed where, as here, Petitioner was notified that the factors were considered. CMS Ex. 2, at 2. If Petitioner disagrees with the CMS assertion that the factors were considered, Petitioner needs to raise the issue of the reasonableness of the CMP in the de novo hearing before me. Emerald Oaks, DAB No. 1800, at 12. Petitioner has provided me with no evidence or argument regarding its compliance history, financial condition, or degree of culpability that I might use in assessing the reasonableness of the CMP.

[W]hile the ALJ must consider evidence which is properly presented to him concerning any of the factors listed in 42 C.F.R. § 488.438(f), including financial condition, in evaluating whether the CMP is within a reasonable range, CMS does not automatically have to offer such evidence as part of its prima facie case. Rather, if a facility contends that its financial condition or some other factor makes a CMP unreasonable, then the facility must raise that contention on a timely basis before any question would arise as to CMS's responsibility for producing evidence as to that factor.

Community Nursing Home, DAB No. 1807, at 22 (2002), citing Emerald Oaks, DAB No. 1800.

The ALJ is . . . to determine whether the amount of any CMP imposed by CMS and challenged by the facility is within reasonable bounds in light of the purpose of the statute and regulations. If the facility presents evidence relevant to any of the regulatory factors in order to contest the reasonableness of the amount of the CMP, the ALJ is to weigh that evidence, along with all the evidence presented by CMS, in making that determination.

Emerald Oaks, DAB No. 1800, at 12-13. See also Coquina, DAB No.1860, at 32. As the DAB has expressed, my review is de novo, and I am not required to delve into the internal decision-making process of CMS officials in arriving at the CMP amount. CarePlex of Silver Spring, DAB No. 1683, at 11.

Accordingly, I must determine simply whether the CMP of $650 is within a reasonable range. The only regulatory factor as to which there is evidence of record is the seriousness of the deficiencies. Pursuant to 42 C.F.R. § 488.404(b), which is incorporated by reference into 42 C.F.R. § 488.438(f), the seriousness of the deficiencies is determined by their scope and severity.

CMS and the State assessed the violation of 42 C.F.R. § 483.25(c), F Tag 314, related to pressure sores, as being a scope and severity level of H, which indicates the existence of a pattern of deficiencies involving actual harm that does not rise to the level of immediate jeopardy. I concluded that CMS failed to establish a prima facie case regarding the example of Resident 45. However, CMS did establish a prima facie case regarding Residents 168, 43, 171, 50, and 72, by showing the development of new pressure sores or the worsening of existing sores. Petitioner failed to meet its burden as to each example. Thus, I conclude that the deficiency existed, that the development of new sores or the worsening of existing sores constituted actual harm, and, based on the number of examples proven, there was a pattern.

Regarding the deficiency cited as a violation of 42 C.F.R. § 483.25(h)(2), F Tag 324, related to accidents, CMS and the State assessed a scope and severity level of G, indicating isolated deficiencies involving actual harm but not presenting immediate jeopardy. My conclusions regarding this deficiency are that CMS prevailed in showing a single incident of actual harm to Resident 72 (example 2), as well as the potential for more than minimal harm with regard to Resident 147 (example 1), Resident 6 (example 3), Resident 14 (example 4), Resident 163 (example 5), and Resident 60 (example 6). Again, scope and severity are appropriately characterized as level G, indicating an isolated instance of actual harm.

The regulation authorizes a CMP in the range of $50 to $3,000 where a deficiency of any scope causes actual harm. 42 C.F.R. § 488.408(d)(2). In this case, I have found two deficiencies involving multiple examples of actual harm. The CMP imposed by CMS is at the low end of the range, and I find it reasonable, given the multiple examples of actual harm that have been proved in this case.

IV. CONCLUSION

For the foregoing reasons, I decide that Petitioner was not in substantial compliance with Medicare and Medicaid participation requirements during the period September 3, 1999 through October 23, 1999. Due to Petitioner's failure to be in substantial compliance, CMS had a basis for imposing a CMP in the amount of $650 per day for the period of noncompliance. The CMP is reasonable.

JUDGE
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KEITH W. SICKENDICK

Administrative Law Judge

FOOTNOTES
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1. Effective July 5, 2001, the Health Care Finance Administration (HCFA) was renamed the Centers for Medicare & Medicaid Services (CMS). 66 Fed. Reg. 35,437.

2. On July 10, 2000, Petitioner filed a written objection to any "arbitrarily imposed time" limits for the conduct of the hearing. Petitioner's objection was provoked by a telephone conference which occurred on July 7, 2000, during which Judge Clifton advised that hearings were not to last more than five days and the parties would each have two and one-half days to present their respective cases. Petitioner did not reassert this objection before me. Further, no arbitrary time-limits were imposed in this case. Accordingly, Petitioner's objection is moot.

3. CMS submitted a listing of errata by letter dated May 2, 2002. No objection or conflicting statement of errata was filed by Petitioner and the CMS corrections to the record are noted.

4. CMS offered its exhibits marked as "HCFA" exhibits. Remarking the exhibits as "CMS" exhibits is unnecessary, as the agency's name change is well known and the erroneous marking should not be confusing. Any reference to a "CMS exhibit" should be construed to be a reference to the exhibit marked "HCFA" with the same exhibit number.

5. In this decision, I refer to the parties' Post-hearing Briefs as "CMS Brief" and "P. Brief." I refer to the parties' Reply Briefs as "CMS Reply" and "P. Reply."

6. A SNF is a nursing facility under the federal Medicare program and a NF is a nursing facility under the state Medicaid program. The Petitioner participates in both and is referred to as a "dually participating facility." See 42 C.F.R. § 488.301. SNFs are governed by section 1819 of the Act while NFs are subject to section 1919.

7. In the 1999 edition of the Code of Federal Regulations, section 498.3(b)(13) is the applicable section. In the 2002 edition, the similarly worded section has been re-numbered as 498.3(b)(14).

8. The State agency alleged the following regulatory violations as deficiencies: 42 C.F.R. § 483.10(b)(5)-(8), F Tag 156, Notice of Rights and Services, at a scope and severity B; 42 C.F.R. § 483.13(b), F Tag 223, Resident Behavior and Facility Practices (Abuse), at a scope and severity D; 42 C.F.R. § 483.15(a), F Tag 241, Quality of Life (Dignity), at a scope and severity E; 42 C.F.R. § 483.15(f)(1), F Tag 248, Quality of Life (Activities), at a scope and severity E; 42 C.F.R. § 483.15(h)(2), F Tag 253, Environment (Housekeeping), at a scope and severity E; 42 C.F.R. § 483.15(h)(7), F Tag 258, Environment (Sound Levels), at a scope and severity B; 42 C.F.R. § 483.20(b)(4)(iv), F Tag 274, Resident Assessment (Reassessment for Significant Changes of Condition), at a scope and severity D; 42 C.F.R. § 483.20(d), F Tag 279, Resident Assessment (Care Plans), at a scope and severity E; 42 C.F.R. § 483.20(d)(3)(i), F Tag 281, Resident Assessment (Services Meet Professionally Recognized Standards), at a scope and severity D; 42 C.F.R. § 483.25, F Tag 309, Quality of Care, at a scope and severity D; 42 C.F.R. § 483.25(a)(2), F Tag 311, Quality of Care (Maintain or Improve Residents' Abilities), at a scope and severity E; 42 C.F.R. § 483.25(a)(3), F Tag 312, Quality of Care (Activities of Daily Living), at a scope and severity E; 42 C.F.R. § 483.25(c), F Tag 314, Quality of Care (Pressure Sores), at a scope and severity H; 42 C.F.R. § 483.25(d)(2), F Tag 316, Quality of Care (Incontinence Care), at a scope and severity E; 42 C.F.R. § 483.25(e)(2), F Tag 318, Quality of Care (Range of Motion), at a scope and severity E; 42 C.F.R. § 483.25(h)(2), F Tag 324, Quality of Care (Accidents), at a scope and severity G; 42 C.F.R. § 483.30(a)(1) & (2), F Tag 353, Nursing Services (Sufficient Nursing Staff), at a scope and severity E; 42 C.F.R. § 483.35(c)(1)-(3), F Tag 363, Dietary Services (Meal Planning), at a scope and severity E; 42 C.F.R. § 483.35(d)(1) & (2), F Tag 364, Dietary Services (Food Preparation), at a scope and severity E; 42 C.F.R. § 483.35(h)(2), F Tag 371, Dietary Services (Food Storage), at a scope and severity F; 42 C.F.R.§ 483.65(a)(1)-(3), F Tag 441, Infection Control, at a scope and severity E; 42 C.F.R. § 483.70(h)(4), F Tag 469, Physical Environment (Pest Control), at a scope and severity F; 42 C.F.R. § 483.75(f), F Tag 498, Administration (Nurse Aide Competency), at a scope and severity E; 42 C.F.R. § 483.75(l)(1), F Tag 514, Administration (Clinical Records), at a scope and severity E; 42 C.F.R. § 483.75(m)(2)-(4), F Tag 518, Administration (Emergency Procedures), at a scope and severity D. CMS Ex. 1. The regulatory references in the SOD correspond to an earlier edition of the Code of Federal Regulations. Thus, some of the subsection numbers are not consistent with the 1999 edition. The substance of the regulatory requirements is the same, in any case.

9. Scope and severity levels are used by CMS and a state when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or a state from the scope and severity matrix published in the State Operations Manual (SOM), section 7400E. A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm. Facilities with deficiencies of a level no greater than C remain in substantial compliance. 42 C.F.R. § 488.301. A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. See State Operations Manual (SOM) § 7400E.

10. The State agency acted as an agent of CMS in this survey process and references to CMS may be read to include its agent.

11. 11 While the SOM is not Alaw,@ it is an articulation of CMS policy regarding the application of the Act and regulations which is used by and binding upon State and CMS surveyors in conducting surveys.

12. CMS has the option to impose category 2 remedies for deficiencies at this level.

13. The SOD indicates a pressure sore on the right hip. CMS Ex. 1, at 36. However, Resident 168's medical records reflect the sore was actually on the left hip, as pointed out by Petitioner. P. Ex. 7, at 5. The surveyor's later comments in the SOD also indicate the presence of a pressure sore on the left hip rather than the right. See CMS Ex. 1, at 38. Facility records at CMS Ex. 40, at 5-16 are also consistent with the pressure sore being on the left hip and right buttock.

14. Nurse's notes from March 15, 1999 reflect that a nurse aide reported that Resident 168 had a 0.7 cm by 0.2 cm skin tear on his left elbow that was cleaned and steri-strips applied. A note from April 2, 1999 reflects that the area had healed. P. Ex. 7, at 20-21.

15. Of course, the records produced by Petitioner show that Resident 168 had previously developed pressure sores which are not the basis of a citation and which I do not consider as an alleged deficiency.

16. The evidence does indicate that Petitioner was making efforts to deal with sores on Resident 168's hands secondary to his contractures. Although not specifically urged by Petitioner, I conclude that obtaining, fitting, and training for use of the hand splints meets the DAB standard of going beyond what merely seems reasonable. I also accept that the wound on the left elbow was a skin tear, as alleged by Petitioner, based on the history of a past skin tear in the same area. A skin tear is not a pressure ulcer and technically not subject to 42 C.F.R. § 483.25(c).

17. Petitioner's medical records appear to use the terms "pressure ulcer" and "pressure sore" interchangeably, and I take the two terms to refer to the same condition.

18. The Plan of Care for Preventive Skin Care for this resident, initiated May 14, 1999, and updated for August and October, 1999, did not call for fleece pads or chair pads. P. Ex. 27, at 23.

19. See CMS Ex. 50, at 5-7 (facility's Pressure Ulcer Progress Reports).

20. Her observations are also recorded in surveyor worksheets at CMS Exs. 52 and 55. Similar observations by another surveyor are recorded in CMS Ex. 50.

21. I do not accept the general allegation that Resident 50 was combative as a defense to the specific allegations of the SOD. Petitioner has made no attempt to connect the two undisputed sets of facts. For example, Petitioner has offered no evidence that, at the time in question, Resident 50 was combative and, thus, prevented timely incontinent care or the placement of a chair pad.

22. Petitioner= s assertion that no tunneling was noted in October 1999, fails to address whether tunneling existed at the time of the survey.

23. The evidence shows that Resident 72 was assessed by the facility as being at risk for falls on June 15, 1999. P. Ex. 17, at 22. I have no evidence she was assessed by the facility as at risk for falls earlier. It is not clear from the doctor's orders why the use of a side-rail was ordered prior to June 15, 1999. It is clear to me that not all records related to this resident have been presented as evidence by the parties.

24. The plan of care does refer to the facility fall protocol (P. Ex. 17, at 22, 25), but I have no evidence before me that reveals the content of that protocol and whether it says anything about the use of side-rails.

25. The earliest Nurse's Notes offered as evidence are dated July 29, 1999, so it is not possible to determine whether or not two side-rails were in use prior to that date. See P. Ex. 17, at 40.

26. Resident 72's medical records in evidence do not reflect any notation that the restraint free alarm sounded when Resident 72 attempted to get out of bed.

27. Approach or intervention #11, which required that side-rails be kept up, has been lined through on the exhibit, but there is no indication of a date or who made the alteration. There is evidence that Resident 14 was eventually placed in a low bed, which would not involve the use of side-rails, and may explain the deletion from the plan of care. Resolution of this fact question is not necessary for resolution of this case.

28. Ms. Alden's notes indicate that she entered Resident 60's room around 3:15 PM, the same time recorded by Ms. Truett, which indicates to me that it was Ms. Alden with Ms. Truett rather than Ms. Dunn as Ms. Truett indicated in her testimony.

CASE | DECISION | JUDGE | FOOTNOTES