SUBJECT:

Beechknoll Caonvalescent Center,

Petitioner,

Centers for Medicare & Medicaid Services

REVISED DECISION

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) (this agency was formerly known as the Health Care Financing Administration (HCFA)) to impose remedies against Petitioner, Beechknoll Convalescent Center, for failure to comply substantially with federal requirements governing participation of long term care facilities in Medicare and State Medicaid programs. These remedies include: denial of payment for new admissions from June 25, 1999 through July 19, 1999, termination of the facility's provider agreement effective July 19, 1999, and a civil money penalty (CMP) of $3,050 per day for 41 days of immediate jeopardy from April 10, 1999 to May 20, 1999, and $200 per day after May 20, 1999, until termination of Petitioner's participation in the Medicare and Medicaid program effective July 19, 1999. However, as discussed below, I find that the period of noncompliance at the immediate jeopardy level concluded on May 16, 2001. Therefore, I sustain a CMP at the immediate jeopardy level for only 37 days, and a CMP of $200 per day thereafter.

I. Background

This case came before me pursuant to a request for hearing filed by Petitioner on July 20, 1999, in accordance with section 1128A(c)(2) of the Social Security Act ("Act") and 42 C.F.R. §§ 488.408(g), 498.40.

Petitioner is a skilled nursing facility participating in the Medicare and Medicaid programs. On January 19, 1999, an abbreviated standard (complaint) survey was completed at the facility by the Ohio Department of Health (ODH) to determine if the facility was in compliance with federal requirements for nursing home participants.

That survey resulted in a finding that Petitioner was not in substantial compliance. The survey alleged isolated deficiencies that constituted actual harm that was not immediate jeopardy. ODH informed Petitioner on January 28, 1999, that it could avoid the imposition of remedies if substantial compliance was achieved by March 10, 1999. ODH accepted Petitioner's subsequent allegation of compliance. However, a revisit as well as standard, extended, and Life Safety Code surveys conducted on March 19, 1999, revealed lack of substantial compliance. A pattern of deficiencies that constituted actual harm but not immediate jeopardy was found. The alleged deficiencies constituted substandard quality of care. Petitioner was notified of the findings on March 31, 1999. Again, ODH accepted Petitioner's allegation of compliance and conducted a revisit survey on May 19, 1999. The conditions at the facility had deteriorated to the point of immediate jeopardy and other substandard quality of care deficiencies were alleged. A monitoring visit on May 21, 1999, revealed that the immediate jeopardy was abated, effective that same day, but that the facility was still out of compliance with federal requirements based on the remaining alleged deficiencies.

In view of the foregoing, CMS accepted the recommendation of ODH, and imposed the following remedies by notice letter dated June 8, 1999:

• Denial of payment for new admissions effective June 25, 1999.



• A CMP of $200 per day effective January 19, 1999, through April 9, 1999. The CMP was increased to $3,050 per day for 41 days that the immediate jeopardy existed from April 10, 1999 to May 20, 1999. Beginning May 21, 1999, the CMP was reduced to $200 per day until compliance was achieved or the facility was terminated.



• Termination of Petitioner's participation in the Medicare and Medicaid programs effective July 19, 1999.⁽¹⁾

In its request for hearing filed on July 20, 1999, Petitioner disputed "the imposition of remedies by HCFA based on the surveys conducted on January 28,⁽²⁾ March 19, and May 19, 1999." Petitioner went on to specifically identify the alleged deficiencies with which it was taking issue and the reasons why these should not have been cited. In its itemized challenge of the surveyors' factual conclusions it referenced only the alleged deficiencies from the May survey and omitted any mention of the January and March 1999 surveys.

The record reflects that on July 16, 1999, CMS issued a further notice to Petitioner following a July 9, 1999 survey which concluded that it was still not in compliance and that termination of its provider agreement would be effective July 19, 1999. A request for hearing regarding CMS's actions based on the July 9 revisit was filed by Petitioner on August 19, 1999.⁽³⁾

By motion and supporting memorandum dated December 1, 1999, CMS sought dismissal of Petitioner's request for hearing insofar as it related to all alleged deficiencies except the challenge to the May 19, 1999, survey. Petitioner countered with a motion to strike evidence regarding the survey findings prior to May 1999, and, in the alternative, to amend its request for hearing.

In a ruling dated February 15, 2000, I ordered dismissal of that portion of Petitioner's appeal that challenged the validity of the remedies imposed as a result of the surveys conducted in January and March 1999.

I held a hearing in Cincinnati, Ohio, from July 11 through July 13, 2000. CMS was represented by Mr. Ted K. Yasuda, and Petitioner was represented by Mr. Geoffrey E. Webster. Petitioner offered 37 exhibits and these were admitted into evidence without objection from CMS as Petitioner's Exhibits 1-37. CMS offered 21 exhibits into evidence and Petitioner objected to each of them. Therefore, CMS's exhibits were admitted piecemeal as reflected in the footnote.⁽⁴⁾ The parties filedpost-hearing briefs: CMS's "Health Care Financing Administrations' Post-Hearing Memorandum" (CMS Br.), on September 18, 2000; "Petitioner's Post-Hearing Brief" (P. Br.), filed October 20, 2000; and, CMS's "Health Care Financing Administration's Post-Hearing Reply Memorandum (CMS Reply), filed on November 14, 2000.

In this decision I will only address CMS's imposition of a CMP of $3,050 per day for 41 days of immediate jeopardy from April 10, 1999, to May 20 1999, and $200 per day after May 20, 1999, until termination of Petitioner's participation in the Medicare and Medicaid programs, effective July 19, 1999.

II. Applicable Law and Regulations

Petitioner is considered a long-term care facility under the Act and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory requirements for participation by a long term care facility are found at sections 1819 and 1919 of the Act, and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs against a long term-care facility for failure to comply substantially with participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the States the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 483 provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying with participation requirements. 42 C.F.R. §§ 488.10 - 488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. §§ 488.300 - 488.335. Under 42 C.F.R. Part 488, CMS may impose a CMP against a long-term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.430. The penalty may start accruing as early as the date that the facility was first out of compliance and continues until the date substantial compliance is achieved or the provider agreement is terminated.

The regulations specify that a CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of CMPs, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and in some circumstances, for repeated deficiencies. 42 C.F.R. §§ 488.438(a)(1), (d)(2). The lower range of CMPs, of from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438 (a)(2).

The terms "substantial compliance" and "immediate jeopardy" are defined terms in the regulations which govern participation of long-term care facilities in Medicare. "Substantial compliance" is defined to mean:

a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.

42 C.F.R. § 488.301.

"Immediate jeopardy" is defined to mean:

a situation in which the provider's non-compliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.⁽⁵⁾

Id.

In determining the amount of the CMP, the following factors specified at 42 C. F. R. § 488.438(f) must be considered:

1. The facility's history of non-compliance, including repeated deficiencies.

2. The facility's financial condition.

3. The seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404.

4. The facility's degree of culpability.

In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Civ. No. 98-3789 (D.N.J. 1999).

The Act and regulations make a hearing available before an administrative law judge (ALJ) to a long-term care facility against whom CMS has determined to impose a CMP. Act, § 1128A(c)(2), 42 C.F.R. §§ 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd 941 F.2d 678 (8^th Cir. 1991).

III. Issues

A. Petitioner's Motion to have the presiding administrative law judge recuse himself.

B. Whether the facility was complying substantially with federal participation requirements from April 10, 1999 to July 19, 1999.

C. Whether CMS's determination of immediate jeopardy is clearly erroneous.

D. Whether the CMP is reasonable.

IV. Ruling, Findings and Discussion

The ruling, findings of fact, and conclusions of law noted below in italics are followed by a discussion of each.

A. Petitioner's motion to have the presiding ALJ recuse himself is denied.

During the course of the hearing, Petitioner requested that I disqualify myself and seek appointment of another ALJ to hear and decide this case. I denied the request inasmuch as I have no personal interest in the matter before me, and consider myself capable of being completely impartial. P. Br. at 2, 3. Petitioner has renewed its motion in its post-hearing brief. For the reasons that follow, I again deny the motion.

42 C. F. R. § 498.45(a) provides that an ALJ may not conduct a hearing in a case in which he or she is prejudiced or partial to the affected party or has any interest in the matter pending for decision. 42 C.F.R. § 498.45 (c) invests the ALJ with the discretion to withdraw or continue with the hearing, subject to review by the Departmental Appeals Board (Board). Petitioner does not directly claim that I am "prejudiced or partial to the affected party" or that I "have an interest in the matter pending for decision." Rather, Petitioner appears to advance the argument that I harbor prejudice in view of an imagined long-standing relationship I have with counsel for CMS, and because some of my evidentiary rulings were not in its favor.

I had been an ALJ with the Departmental Appeals Board for less than a year when I presided over the hearing in July 2000. I had met CMS's counsel, Mr. Ted Yasuda, for the first time approximately a month earlier, in a hearing over which I presided in Chicago, Illinois. On that occasion, my only communications with Mr. Yasuda, as far as I can recall, occurred during the course of the proceedings. My next encounter with Mr. Yasuda came in the course of the hearing in this case. Petitioner's notion that "we two have a long association"(Tr. 434, line 25; Tr. 435, line 1) and "too close relationship"(P. Br. at 2, 3) is absolutely baseless. Counsel should feel free to conduct fearless, vigorous, and effective advocacy, "which is the supreme object of a lawyer's calling." Offut v. United States, 348 U.S. 11 (1954). However, gratuitous innuendos are contrary to a lawyer's calling or effective advocacy.

Petitioner's second point of contention stems from his dislike for some of my rulings. I will discuss the examples he provides.

1. Ruling at Tr. 432-435.

Petitioner contends that I permitted CMS to grossly violate residents' rights of confidentiality in the presentation of its case. The matter appears at Tr. 432-435. At that point in the proceedings, Petitioner took issue with my ruling to admit unredacted documents into evidence, with the understanding that redacted replacements would later be provided by CMS. Petitioner apparently found this highly objectionable. The thrust of its initial argument lays claim to a violation of Board rules. However, Petitioner did not cite any rule. The second argument propounded by Petitioner is to the effect that "we are not in Spain" and this is not a Star Chamber (emphasis added).⁽⁶⁾ The argument is specious, and warrants no response. Tr. 434.

2. Ruling Tr. 219-231.

A discussion of the issue relative to this ruling requires some background to help put matters in perspective. On the morning of July 11, 2000, when the hearing commenced, counsel for CMS was well disposed to the admission of all of Petitioner's proposed exhibits without objection. The offer was made, contingent on being extended the same courtesy. Petitioner refused the offer and insisted on a piecemeal presentation of each of CMS's exhibits. Tr. 226, lines 16-24.

CMS had marked each proposed exhibit in accordance with Rule 4 of the Civil Remedies Division Procedures. The total number of CMS's proposed exhibits was 21. As each of its witnesses testified, CMS severed pages from previously marked remaining proposed exhibits, and offered these into evidence. Once CMS laid the proper foundation, I granted the motion for admission, albeit over Petitioner's objection, each time. Inasmuch as Petitioner required testimonial foundation for each document admitted, it was necessary to sever pages especially when more than one witness addressed the same numbered exhibit. For example, HCFA Ex. 18 consisted of 43 pages. Some pages of HCFA Ex. 18 were admitted during the testimony of Ms. Ann Alden (e.g., HCFA Ex. 18, pp. 5-8; Tr. 60), while the admission of other pages from that same exhibit was supported by the testimony of Ms. Debbie Truett (e.g., HCFA Ex. 18, pp. 29-32; Tr. 458, lines 22-25; Tr. 459, lines 1-5). Petitioner took the position, however, that it was improper to admit CMS Ex. 18 except in its totality, in one single act.

Thus, when CMS offered pages 5-8 of HCFA Ex. 18, Petitioner objected because the document was incomplete. Tr. 160. Again, when CMS offered pages 29-32 of proposed HCFA Ex. 18, Petitioner objected for the same reason. I quote from the transcript at page 459:

Mr. WEBSTER: Yes, I have an objection. It was represented to me that we have HCFA Exhibit 18 that was 43 pages long, so it's an incomplete exhibit.

The logical unfolding of Petitioner's reasoning would require CMS to present simultaneous, plural testimony, in order for HCFA Ex. 18 to gain evidentiary access into the record!⁽⁷⁾

The preceding explanation is helpful in understanding my ruling at Tr. 219-231. However, to get the full scope and flavor of the issue, I will back up to Tr. 215. At page 215 of the transcript, Petitioner was cross-examining Ms. Ann Alden. During the cross-examination, Petitioner offered into evidence, what it referred to as HCFA Ex. 21, pp.10-17. That move was confusing for two reasons. In the first instance, according to Petitioner's unique reasoning, it would be an incomplete document. Secondly, if the document in question was already an exhibit, why would Petitioner need to enter it again? What became apparent was that Petitioner deemed CMS's "proposed exhibits" as documents it could freely use (whether admitted into evidence or not) to present its case-in-chief on cross-examination as if they had been admitted, because for that purpose they were "HCFA's exhibits." Tr. 217, 223. On the other hand, Petitioner posed strenuous objection to CMS's use of those same documents on direct examination of its witnesses to meet its burden of establishing a prima facie case. In the particular instance of HCFA proposed Ex. 21, pp. 10-17, these pages had not been offered into evidence by CMS, and could not be deemed to be "HCFA exhibits." Furthermore, Petitioner contended that just because CMS had originally proposed certain documents as exhibits, whether admitted in to evidence or not (including nurses' notes and other documentation created by the facility in the due course of business), they became CMS records. Consequently, Petitioner reasoned that it could establish its defense theory on cross-examination, through those "HCFA exhibits" (that had somehow evolved to become CMS's records, although created by the facility). Moreover, Petitioner asserted it would have a basis for impeachment of CMS's witness, demonstrated by "HCFA's own records."

I found that Petitioner was going beyond the scope of legitimate inquiry on cross-examination, and ruled that to use CMS's witness as it intended, was impermissible. I did afford Petitioner the opportunity to call the witness as its own during the presentation of its case-in-chief. Petitioner agreed to do this. Tr. 221. The other portion of my ruling was also related to the scope of cross-examination. Petitioner was attempting to use CMS's witness to establish, through institutional records of which the witness had no first hand knowledge, that a certain resident refused to cooperate with care. Tr. 215, 231. I ruled that Petitioner was opening a whole new line of inquiry in trying to establish that its institutional records (which, according to Petitioner, had somehow become HCFA records) reflected a pattern and practice existed with respect to a resident's refusal to accept care. In that regard, I ruled it would be more appropriate to have facility personnel, who observed and supervised the residents on a daily basis, address the existence of any pattern and practice. I found that Petitioner's back door approach could put CMS at odds with its own witnesses, while allowing Petitioner to present its case-in-chief without subjecting facility staff to having their credibility tested on cross-examination. Tr. 225.

3. Ruling at Tr. 539-541

At page 539 of the transcript, Petitioner sought further clarification of my ruling concerning the use of exhibits during cross-examination. Of course, the issue was whether Petitioner would be allowed to refer to exhibits previously offered by CMS, but not admitted into evidence. I specifically instructed Petitioner that I would not allow the use of such documents to introduce new evidence that would be more properly introduced through its own witnesses. Tr. 540. At the top of page 541 of the transcript, I continued to explain my ruling:

Not to develop new issues. It's to address issues that were addressed in direct examination, to explore those and test the witness' credibility regarding those issues, not to present your case in chief at that point with new documentation and use that witness to introduce new evidence that you would introduce with your witnesses.

I should also note that the Civil Remedies Division Procedures gives me discretion to bar a party from introducing an exhibit not previously listed. In this instance, Petitioner was precisely attempting to do just that. That is why I limited the use of those documents only for the purpose of testing the witness' credibility, but not to introduce new evidence. See Civil Remedies Division Procedures, Rule number 4.

In its closing remarks regarding the above rulings, Petitioner shows its umbrage by saying that both are indicative of the procedural morass. I can only guess who is the creator of that morass inasmuch as the thought is left dangling.

4. Ruling at Tr. 22-23

Petitioner complains that CMS was allowed to introduce witnesses not previously identified to Petitioner. CMS argued that on February 7, 2000, it mailed its lists of exhibits and witnesses to the Civil Remedies Division and to Petitioner. The original is date-stamped as having been received at the Civil Remedies Division on February 17, 2000. CMS further asserts that although the document lacks a certificate of service, it does indicate that a copy was sent to an attorney in the law firm representing Petitioner. I understand Petitioner's position to be that a strict construction of the Civil Remedies Division Procedures requires that nothing may be considered by me unless there is attached to it a certificate of service that attests that it was sent to opposing counsel. Tr. 18. I do not agree with Petitioner's understanding of those rules. Rule number two of the Civil Remedies Division Procedures provides that a party must send a copy to the other party, and must "note or certify, that the submitting party has served the other party." (Emphasis in the original). Nowhere in the rules does it say that I am barred from considering anything that does not have an attestation or certificate of service to the other party. It suffices to show that it was noted that the other party was served. In the case before me, CMS noted service to opposing counsel by indicating "cc" to Mr. Randall Richards, one of Petitioner's attorneys who is apparently associated with Mr. Webster.

Additionally, on June 16, 2000, Petitioner requested the issuance of subpoenas for the appearance of the two surveyors CMS intended to use in the presentation of its case-in-chief. In its response dated June, 26, 2000, CMS informed Petitioner that subpoenas for those witnesses were unnecessary because it was calling both of them to testify on its behalf. At that time, Petitioner did not indicate that it was surprised that the two surveyors would be called by CMS to testify. Furthermore, Petitioner specifically acknowledged receiving CMS's response in opposition to the issuance of subpoenas that contained the names of the witnesses CMS would call to testify. Tr. 22. Since Petitioner intended to call CMS's witnesses and was informed as well by CMS that it would be calling both of them to testify, thus obviating the need for subpoenas, there is no element of surprise. Finally, Petitioner has not shown how it was prejudiced by my ruling to allow CMS to introduce the testimony of its two surveyors.

5. Ruling at Tr. 782

Petitioner adduced testimony regarding the facility's improvement after it was taken over by new management. This testimony transcended the date of the last survey at issue in this case. Tr. 648. Consequently, CMS was permitted to inquire on cross-examination as to the professed improvement. Petitioner has failed to show how it was prejudiced by the inquiry into its performance after the July 1999 survey.

There is one other matter that Petitioner raises but does not support by reference to the record; thus, I am unable to address it. I refer to its assertion that I engaged in improper conduct by ordering a witness not to answer a question, when no objection was filed. P. Br. at 3. It is irresponsible for an attorney to characterize a judge's conduct as improper and not offer proof.

In summary, Petitioner does not point to any extrajudicial source of bias, except the unfounded accusation of a close relationship between me and counsel for CMS. The rulings referenced by Petitioner and discussed above, fail to constitute a showing of bias. See St. Anthony Hospital, DAB No. 1728 (2000).

It is unfortunate that Petitioner's counsel has confused this case with a cause, and vigorous advocacy with misguided zeal. His general demeanor here is not dissimilar to that which he displayed years ago in the case of Ohio Department of Public Works, DAB No. 66 (1979). An appellate panel of the Board had this to say about Counsel's behavior during the course of the hearing:

Although on the substantive issue our decision favors the State, we note with concern the obstructive character of the representation the State has received in this case. Counsel appeared determined to preclude alike a substantive decision in the State's favor (Transcript, pp. 10-15, 86-87) and a cooperative clarification with opposing counsel of substantive issues that might well have resulted in a quicker decision supporting the State's position and better long term Federal-State relations . . . Instead, counsel appeared to seek by choice confrontations on procedural excursions created by himself, in which he repeatedly violated the Board's rules of which he was fully aware, and filed with the Board certifications which were misleading and appeared in context calculated to mislead . . . His conduct in this and other respects was obstructive and distracted from the expeditious consideration of the substance of an appeal which the Board finds meritorious in spite of counsel's cantankerous conduct.

We do not generally comment publicly on behavior of counsel except favorably. We are moved to comment in this case because of our concern that this extraordinary behavior not be repeated or initiated by others, and that neither the State, nor opposing counsel nor the Board suffer from it in the future.

Id. at 1.

B. The facility was not in substantial compliance with federal participation requirements from April 10, 1999 to July 19, 1999.

Below, I will discuss examples of failure by Petitioner to comply with the pertinent federal participation requirements.

1. Pressure sores (F 314)

42 C.F.R. § 483.25(c) requires that the facility must ensure that a resident who is admitted without pressure sores does not develop them, unless the individual's clinical condition demonstrates that they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and new sores from developing.

a. Resident number 54 (R54)

R54 was admitted to Petitioner's facility with no bed sores, and was not provided pressure relief devices or other appropriate care to prevent skin breakdown. HCFA Ex. 3, pp. 28-30.

Based on observation and record review, CMS found that R54 developed a facility-acquired open pressure sore on the left buttock subsequent to admission on September 18, 1998. An assessment performed on April 7, 1999, revealed no pressure sores and no history of pressure sores. On May 12, 1999, R54 was observed at various times, lying on her back with no position changes. During incontinence care, on May 13, 1999, the resident exhibited a two by one centimeter open pressure sore on the left buttock and a two by two centimeter persistent area of redness on the right gluteal fold. The mattress on R54's bed did not provide pressure relief, as was confirmed by a staff nurse present in the room. On May 15, 1999, the resident was observed positioned in her bed, as well as in a wheelchair, without pressure relief.

Ms. Ann Alden, one of the surveyors, testified that on May 13, 1999, a charge nurse admitted that a special mattress for pressure relief was not provided. Ms. Alden stated that the absence of a pressure relief device puts the resident at risk for development of pressure sores. Tr. 45, 46. See also HCFA Ex. 14, p. 26. In the specific case of R54, the plan of care reflected a physician's requirement that a therapeutic mattress be provided. Notwithstanding this, the facility did not comply with the physician's order. Tr. 49, 50; HCFA Ex. 13, p. 32. It was Ms. Alden's finding that as a result of the absence of aggressive preventative measures, the resident developed an avoidable pressure sore. Tr. 46.

Ms. Alden further testified that on May 12, 1999, she observed R54 lying on her back at 3:45 p.m., 4:00 p.m., and 6:00 p.m. She added that her observations were made from a vantage point at the nurses' station where she could detect anyone entering the resident's room. During the time of her observations, she did not see facility personnel enter R54's room. Had she observed anyone go in, she would have followed to take note of the care being provided. Thus, although she did not have her eyes fixed on the resident 100% of the time, Ms. Alden was in a position to detect facility intervention. It was also her opinion that whereas position changes are recommended every two hours, in the case of a resident such as R54, who was totally dependent, and had skin breakdown, changes are advisable every hour or half hour. Tr. 286-289.⁽⁸⁾

On May 14, 1999, Ms. Alden observed R54 in a wheelchair from 8:00 a.m. to 11:00 a.m. without a pressure relief device. She was concerned that the resident was sitting for long periods of time in the wheelchair as well as in bed on her back with no aggressive preventive interventions. Tr. 55-56.

Counsel for Petitioner cross-examined Ms. Alden as to whether she observed R54 uninterruptedly during the times noted in the survey, yet Petitioner offered no evidence regarding the measures taken to prevent skin breakdown in this resident. Tr. 281-283.

The assumption inherent in the regulation is that a resident should not have pressure sores unless they are unavoidable. Petitioner has not denied the existence of a pressure sore in R54 nor that it was facility acquired. Consequently, it was incumbent upon Petitioner to demonstrate that the pressure sore was unavoidable, once the surveyors identified its existence. Cross Creek Health Care Center, DAB No. 1665 (1998). While Petitioner has failed to come forward with evidence in that regard, CMS has affirmatively shown that Petitioner did not employ pressure relief devices nor take other measures such as timely shifting the resident's position.

b. Resident number 74 (R74)

R74 was observed on May 12, 1999, with a facility acquired pressure sore that was avoidable. Petitioner took no measures to prevent the sore from occurring. HCFA Ex. 3 pp. 30, 31.

R74 had a diagnosis of a surgically repaired fracture of the right hip. He was assessed by the facility on May 12, 1999, at 9:30 a.m. as having a history of a recently healed pressure sore on the coccyx. The resident was observed on May 12, 1999, at 9:30 a.m. with a pressure sore that was facility-acquired and avoidable. On May 6, 1999, the resident was assessed as dependent on staff for mobility and transfer. He had a colostomy and indwelling urinary catheter. The surveyor observed the resident in his wheelchair and bed for extended periods and noted he was not repositioned.

On May 12, 1999, at 4:15 p.m. the resident was observed while a staff nurse performed a skin assessment. There was an open, bloody, one centimeter pressure sore on his right buttock. The mattress was described by the nurse as a standard ultra foam mattress and was covered with a blanket-like pad. There was no preventative cushioning device on the wheelchair or on the mattress of the bed. The care plan for impaired skin integrity only described that nursing would turn the resident every two hours while in bed.

Ms. Alden, the State surveyor, testified that R74 was dependent on staff for mobility and transfer due to surgical repair of a fractured hip. Tr. 57. She opined that R74 was not provided effective preventative treatment or pressure relief in his wheelchair or in his bed. She observed him with an open bloody sore on his right buttock, and despite this, he was allowed to sit in his wheelchair and lie in bed for prolonged periods without pressure relief. Tr. 57.

Ms. Alden further testified that although incontinent residents are more prone to skin breakdown, R74 did not have such a problem because, in his case, feces and urine were collected in colostomy bags. Thus, in her opinion, it was clear that the skin breakdown in R74 was related to pressure. Tr. 59.

Petitioner's argument that in the absence of a physician's order, the facility had no duty to provide any pressure relief devices and could not provide treatment for skin breakdown, borders on the absurd. See P. Br. at 11.

The regulation is unequivocal in its requirement that the facility must ensure that a resident who enters the facility without pressure sores does not develop them unless the individual's clinical condition demonstrates that they were unavoidable. Additionally, the regulation establishes that a resident having pressure sores must receive necessary treatment and services to promote healing. 42 C.F.R. § 483.25(c). I do not read the regulation to mean that the facility's duty is contingent upon a physician's prior directive. The duty of care in this regard is an onus that the regulation places upon the facility, and which the facility cannot evade by shielding itself behind the absence of a doctor's prescription. Petitioner has not met its burden of coming forward with evidence to contradict CMS's prima facie case showing that the facility was not in substantial compliance concerning the care and treatment provided to R74. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Civ. No. 98-3789 (D.N.J. 1999). CMS has established that as a result of the survey conducted in May 1999, it was found that R74 had a facility-acquired pressure sore that was avoidable. Petitioner's argument that it was not duty-bound to take appropriate measures to prevent or treat these is wholly unacceptable. This is particularly true in light of its responsibility to contact a physician when it notes that a resident has acquired a skin breakdown such as that exhibited by R74. Tr. 82. Finally, contrary to Petitioner's assertion, there is no evidence that a resident with a diagnosis of renal failure and COPD (Chronic obstructive pulmonary disease) is very likely to develop pressure sores. Tr. 306, 307. See also P. Br. at 11.

c. Resident number 62 (R62)

R62 was observed on May 14, 1999, with a previously unidentified, facility-acquired, open pressure sore on the right buttock. The resident was provided with a therapeutic mattress, the effect of which was defeated by the use of several layers of bedding. HCFA Ex. 3, pp. 31, 32

R62 had a diagnosis of left cerebral infarct with right hemiparesis, expressive aphasia, and status post bilateral lower extremity amputation. On May 14, 1999, the resident was observed with an unidentified, facility-acquired open pressure sore on the right buttock. Care planning for skin integrity included the use of a therapeutic mattress. At different times on the 12^th, 13^th, and 14^th of May 1999, the resident was observed positioned on her back with more than two layers of bedding over the therapeutic mattress. It was revealed through observation and interview with staff, that placing bedding on top of the therapeutic mattress defeated its purpose.

Ms. Alden, the State Surveyor, testified that R62 had suffered severe strokes and had bilateral amputations of her lower extremities. R62 needed extensive help with activities of daily living, and developed serious pressure sores. On May 12, 1999, it was noticed that the resident had a stage III⁽⁹⁾ pressure sore on the coccyx and left buttock. Tr. 65. At 10:37 a.m. that day, Ms. Alden observed R62 to be on a Clinitron Flow bed with layers of bedding between the skin and the mattress. This raised a concern in her mind because the purpose of the therapeutic mattress is to allow the thin protective coating between the skin and the mattress to provide the airflow that keeps pressure points off the mattress. The extra bedding placed between the resident and the bed created an undesirable surface of flatness or pressure between the mattress and the resident. Tr. 68, 69. The inference that I draw from this is that a pre-existing pressure sore was exposed to deterioration by improper use of a therapeutic mattress. Ms. Alden was concerned because in addition to observing a serious stage III cratered wound, she also detected a previously unidentified open sore on the right buttock for which no new orders were generated nor was there indication of physician notification. Tr. 76. She described the latter as facility-acquired and avoidable in her worksheet. HCFA Ex. 14, p. 61. Although a change in the resident's condition should be documented as soon as it is noted, the newly acquired open sore did not appear to be noted on May 14, 1999, when Ms. Alden first observed it, nor was there documentation of it when she returned on May 18, 1999. Tr. 77, 81.

I find that R62 did not receive necessary treatment and services to promote healing of pre-existing pressure sores nor did Petitioner come forward with evidence to show that appropriate actions were taken to prevent new sores from developing. Thus, CMS's prima facie case of non-compliance remains uncontradicted. See 42 C.F.R. § 483.25(c)(2).

d. Resident number 53 (R53)

R53 developed facility acquired stage II and III pressure sores which were avoidable. She was provided a therapeutic mattress, the purpose of which was defeated by the use of multiple layers of bedding. HCFA Ex. 3, pp. 32, 33.

R53 was identified by the facility staff on May 12, 1999, with a stage IV pressure sore on the coccyx. This had been previously documented in the clinical record in the March 19, 1999, assessment. R53 also developed a stage II pressure sore on her right foot on April 29, 1999. On May 12 and 14, 1999, R53 was observed with multiple layers of bedding on top of the therapeutic mattress. Through interviews with the staff nurse on May 13, 1999, It was learned that the facility was aware that the purpose of the therapeutic mattress would be defeated with the use of layered bed linen. Additionally, the resident was observed on May 12 and 17, 1999, positioned in a wheelchair with both feet on the floor and no foot protectors. See HCFA Ex. 14, p. 53.

In the case of R53, the record demonstrates that she developed avoidable, facility-acquired, pressure sores, and was provided with a therapeutic mattress. HCFA Ex. 14, p. 53. However, Petitioner, by employing multiple layers of bedding, defeated the effectiveness of the mattress. Ms. Alden testified that, notwithstanding the facility's awareness of the improper use of the therapeutic mattress on May 12, 1999, it was not until May 18 that two of the layers were removed. Tr. 88. CMS established a prima facie case of non-compliance and Petitioner did not refute CMS's assertions nor address them in its post-hearing brief.

From the examples noted above as to Tag 314, it is undeniable that Petitioner failed to ensure that residents who entered the facility without pressure sores did not develop them. Furthermore, Petitioner did not advance any evidence regarding specific affirmative steps taken to prevent the pressure sores nor did it rebut CMS's assertion that they were avoidable. Additionally, Petitioner did not ensure that a resident with pressure sores received necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. 42 C.F.R. §§ 483.25 (c)(1), (2). Petitioner challenged inconsequential details of the surveyor's findings, but not the findings relevant to the deficiencies at issue. Thus, as concerns the prevention and treatment of pressure sores, Petitioner was out of substantial compliance beginning April 10, 1999, within the context of the May 19, 1999, survey.

2. Quality of Care: Accident Hazards (F 323)

42 C.F.R. §483.25 (h)(1) requires that the facility must ensure that the resident environment remain as free of accident hazards as possible.

a. Resident number 11 (R11)

Petitioner failed to provide R11 with an environment free of accident hazards by exposing her to risk of entrapment. Petitioner's lack of intervention allowed the resident to become entrapped in side rails, putting her at risk for strangulation, chest compression, and death. This constituted immediate jeopardy. HCFA Ex. 3, pp. 43-45.

The surveyor noted that on April 10, 1999, R11 was found by facility staff with her legs out of the bed, on the floor, and her upper body "wedged" between the mattress and the half side rail. Facility documentation revealed that the resident's skin was cool and clammy, the lower extremities were mottled to the knees, and her color was pale. The clinical record was silent to interventions to prevent further entrapment and falls from the bed.

On May 12 and 13, 1999, the resident was observed in bed with two unpadded half side rails raised, and no interventions in place to prevent further entrapment. The nurses documented that the resident was found on the floor on May 14, l999. She had slid from the bed. The resident's mattress was changed on May 17^th, and wedge pads were placed under the mattress. On May 18, l999, the resident was observed lying on the left edge of the bed, directly against the unpadded side rail. The surveyor detected a gap between the mattress and side rail.

R11 had a diagnosis of osteopenia, cerebral vascular accident, right side hemiparesis, status post unrepaired right hip fracture in February l999, and aphasia.

Ms. Debbie Truett testified that she began the survey of Petitioner on May 12, l999. Tr. 378. As a result of her record review, she determined that on April 10, l999, R11 was found by nursing staff wedged between the side rail and the mattress, and bed frame. When found, the resident's skin was cool, clammy, and pale. Circulatory difficulty was evident from mottling or discoloration of the lower extremities. Tr. 373.

Ms. Truett noted that when a resident is entrapped there is danger of chest compression, suffocation, and even death. Tr. 374. Upon inquiry, the facility staff identified the bedding being used by the resident at the time of the survey as the same bed she was in on April 10, l999. Ms. Truett was able to observe a gap of approximately four or five inches between the mattress and side-rail. Tr. 376.

Entrapment occurs, Mr. Truett explained, when a resident is caught or trapped between the side-rail and the mattress of the bed, and they are unable to free themselves either because of their clinical condition or the tightness of the space. Tr. 377. In the case at hand, the resident's condition made her very dependent on staff for assistance. Not only did she have severe limitations of motion, but her condition was further compromised by her inability to cry out for help due to aphasia. Tr. 378. I find that R11's overall condition placed her at high risk for entrapment.

Ms. Truett learned from her review of facility records, as well as from confirmation by the staff, that no intervention was implemented from the time of R11's entrapment on April 10, l999, to the initial survey visit on May 12, l999. Tr. 388. Moreover, on May 14, the resident was found on the floor after having slid from the bed. It was not until after this second incident occurred, that the facility determined to address R11's risk of entrapment and fall from her bed. On May 17^th, the staff placed wedged pads underneath a new mattress they had provided for R11. Tr. 389, HCFA Ex. 15, p. 20.

The survey concluded on May 19, l999. On May 20^th, Ms. Truett informed Petitioner that because of the unsafe use of bed rails, the facility had failed to ensure that the resident's environment was as free from accident hazards as possible. She called at noon on the 20^th of May to put the facility on notice regarding the immediate jeopardy finding, and on the 21^st of May verified that the deficiency was corrected with the purchase and deployment of a Roll Guard therapeutic mattress. This mattress is a "scoop" type mattress, with raised sides that prevents residents from sliding or rolling out of the bed. Tr. 402.

I find that CMS established a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. §483.25 (h)(1). CMS presented uncontradicted evidence that R11 suffered side rail entrapment on April 10, l999, and no interventions were initiated to prevent recurrence until May 17^th. The resident in question was extremely frail, and lacking in strength and mobility. Additionally, she was unable to cry out for help due to her aphasia. These special circumstances surrounding R11 should have created a heightened awareness in Petitioner to take immediate action to prevent further entrapment situations. Not only did Petitioner have a duty to protect R11 from hazards of the type here in question, but it was also bound to assess the situation of others who might have been similarly situated.

In conclusion, I find that Petitioner was not in substantial compliance with 42. C.F.R. § 483.25 (h)(1), but only through May 16, l999. Although Petitioner implemented an intervention to correct the situation involving R11 on that date, CMS contends that such intervention was ineffectual. As I explain below, I do not agree with CMS.

Ms. Truett testified that the wedges that were placed under the resident's mattress on May 17^th were pressed with the thin ends facing each other to the point of merely making the mattress higher but leaving it flat. Tr. 390.

Petitioner contends, on the other hand, that the wedges were an appropriate intervention. Mr. Kent Harrington, Petitioner's CEO, described the wedges to be approximately 5 feet in length and 13 inches wide. The thick end of the wedge was about 5 inches, and reduced to a thin edge on the opposite side. The mattress itself was 35 ½ inches wide. Tr. at 390.

Ms. Truett stated that the wedges were pressed up against each other to the point where one was on top of the other. In her view, the way the wedges were positioned only had the effect of raising the mattress, but leaving it with a flat surface. Tr. 390. In that case, the mattress would be expected to have a cantilever effect of close to 12 inches on either side. I find Ms. Truett's statement difficult to reconcile with her testimony that on May 18, l999, she observed the resident lying on the left edge of her bed directly against the unpadded half side rail. I find it illogical to conceive that the mattress was still flat, even as the resident lay on its left edge. It appears that bed coverings must have obstructed Ms. Truett's view. Certainly, if the resident was leaning up against the side rail, and the mattress did not slope down into a gap causing her to fall or slide off the bed, I am inclined to conclude that it was the thick end of the wedge that prevented her from falling.

Although Ms. Truett opined that the wedges employed by the facility to prevent R11 from being entrapped were not intended for that purpose, she was equally of the opinion that other remedial devices could have been employed. Among these, she included blankets, swimming noodles, and pillows. I am not persuaded that these "field expedients" are any more effective than the wedges deployed.

b. All 82 Residents

The facility did not ensure that the resident environment remain free of accident hazards due to unsafe hot water temperatures that affected all 82 residents. HCFA, Ex. 3 pp. 45-47.

On May 13, 1999, the surveyor observed a pattern of unsafe water temperatures throughout the facility, and so notified the administrative staff immediately. The water temperature in the bathroom of resident rooms 203 and 204 was measured at 130F. The water temperature in the bathrooms of resident rooms 116, 113, 104, 214, 209, 206, and 205 was measured at 128F. In the bathrooms of resident rooms 120, 110, and 213 the temperature was measured at 126F.

In the common shower and tub rooms on the second floor, the water temperature in the sink was measured at 130F, and the tub water measured at 128F. On the first floor, the water temperature in the sink was 128F, and the men's shower measured 128F. According to the Ohio Fire Academy, it would only take 30 seconds of direct contact with water at a temperature of 130F to sustain serious burns. The surveyor noted the facility to have residents with significant skin impairment, as well as confused and mobile residents who were at risk of hot water burns.

Interviews with administrative and maintenance staff on May 13, 1999, elicited that they were not aware of the problem with the hot water prior to being notified by the surveyor⁽¹⁰⁾. After sharing and completing an assessment of the hot water situation, the facility notified a repair company which visited the facility later the same day and made corrective repairs. Prior to exiting the facility on the evening of May 13^th, the surveyor measured the water temperatures and obtained readings at or below 110F.

Ms. Truett testified that she noted elevated water temperatures beyond safe levels in the resident area faucets as well as the common areas. She indicated that licensure rules identify safe water temperatures at 110F, and she had found temperatures to be as high as 130F. Water that hot, said Ms. Truett, is classified as sufficient to cause a blistering burn requiring treatment. Tr. 443-445.

Petitioner contends that it appropriately tested the water in its facility and maintained testing records. From that, it argues that the deficiency does not exist inasmuch as testing and record keeping was being done. Furthermore, Petitioner relies on Ms. Truett's testimony on cross-examination to establish that the issue regarding elevated water temperatures stems from a disagreement in the readings obtained by the facility and the surveyor. P. Br. at 13.

Petitioner's argument misses the point. The issue is not whether it tested the water and maintained a temperature log. Additionally, a mere showing that a disagreement existed between the surveyor's recorded temperatures and those logged by the facility fails to rebut the prima facie case established by CMS. Whereas Petitioner merely brought out on cross-examination that the facility kept a temperature log, and the recorded temperatures differed from those reported by the surveyor, CMS advanced the following uncontradicted evidence:

• Ms. Truett physically tested the water, and found it so hot that she was unable to maintain contact. HCFA Ex. 3, p. 45.
  

• Ms. Truett tested the water throughout the facility and observed temperature levels ranging from 126F to 130F. HCFA Ex. 3, p. 46.
  

• Safe temperature levels have been established at 110F. Tr. 444.



• Temperature levels of 130F can cause blistering burns. Tr. 445.



• Petitioner summoned a repair company that visited the facility the same day of the survey and made corrective adjustments. Petitioner did not indicate that the repair company reported that no adjustments were required. The evidence of record shows that adjustments were in fact made, and afterwards, Ms. Truett obtained readings at or below 110F



• A nurse aide reported to Ms. Truett that the water had been too hot for over a month, and two nurse aides that Ms. Truett talked to stated they had to be careful not to let the water get too hot. Tr. 578, 579.

By way of a question to Ms. Truett on cross-examination, Petitioner suggested that it was not non-compliant as to this Tag because no evidence exists of a resident having been burned as a result of hot water in the facility. Tr. 577. The notion that harm must first come to a resident before CMS is allowed to take corrective action with respect to a skilled nursing facility to protect the health, safety, welfare, and rights of those residents runs counter to the letter as well as the spirit of the Act.

I conclude that the credible evidence shows not only that CMS presented a prima facie case that Petitioner was in violation of 42 C.F.R. §483.25(h)(1), but also that Petitioner failed to overcome CMS's case by a preponderance of the evidence.

3. Accident prevention (F 324)

42 C.F.R. § 483.25(h) requires that the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

a. Resident number 44 (R44)

Petitioner failed to provide R44 with adequate assistance and supervision to prevent accidents. As a result of Petitioner's failure, R44 experienced falls and sustained injuries. HCFA Ex. 3 pp. 52, 53.

R44 had diagnoses of a fractured right hip and dementia. On February 18, 1999, he was assessed as requiring staff assistance with ambulation, transfers, and toileting. He was also known to be forgetful about the use of the call light, and had a long history of falls. Although an intervention in February 1999 resulted in the application of a body alarm, the order was discontinued on March 17, 1999, on the basis that the resident made no attempts to ambulate unassisted.

The clinical record revealed that at 4:40 p.m. on April 3, 1999, the resident was found by the nursing assistant sitting on the bathroom floor with his head against the wall, and urine on the floor. On April 6, 1999, at 3:00 p.m., R44 was found by his bed on the floor with a 1.5 centimeter skin tear on the left elbow. On April 17, 1999, at 10:30 a.m., a family member found him on the floor next to his wheelchair. On April 19, 1999, the clinical record revealed a blue area on the resident's chin.

A physician's order was obtained for a body alarm only while the resident was in bed. On May 13, 1999, at 7:10 a.m., it was observed that there was no fall intervention per toileting as planned. R44 was observed on May 18, 1999, in bed with no personal alarm attached.

Ms. Alden, the surveyor, testified that R44 had a fractured right hip and dementia. He required assistance with ambulation, transfers, and toileting. The facility noted that R44 had a history of falls and that he was prone to attempt ambulation by himself. Because of his history of falls, the facility applied a body alarm to R44⁽¹¹⁾, but discontinued it beginning March 17, 1999, after concluding that the resident no longer needed it. Tr. 94.

Notwithstanding the facility's conclusion in March 1999 that R44 no longer required the body alarm, he suffered several falls in the month of April 1999. When he was found in the bathroom on April 3, 1999, there was urine on the floor. When he was found on the floor on April 6, he exhibited a skin tear on the left elbow. He experienced other falls, but it was not until April 19, 1999, that Petitioner resumed use of the body alarm, after the resident showed evidence of a reddish blue area on the chin. Tr. 97.

In defense of the facility, counsel for Petitioner argued against characterization of the incidents where R44 was found on the floor as falls. He reasoned that it could not be concluded that the resident had fallen just because he was found on the floor. Counsel suggested other possibilities, citing his own experience of sitting on the floor to watch television. Tr. 98, 99. Petitioner also contends that it was by order of the attending physician that the body alarm was discontinued, and that the surveyors overlooked the resident's history of ignoring staff requests to await for assistance with ambulation. P. Br. at 8.

It is my finding that R44's floor experiences were in fact the result of having fallen. Petitioner argues that the resident may have decided to sit on the floor rather than suffering falls. That is mere speculation because no staff member was a witness to such behavior. However, the very fact that the resident somehow made his way to the floor, whether it be in the bathroom, by his wheelchair or the bed, and the facility was unable to explain how the incident occurred, is an indication of failure to supervise. From the reinstatement of the body alarm on April 19, 1999, there appears to be a recognition that the resident was in fact experiencing falls, and not merely expressing a preference for spending time on the floor. It does not strain the imagination to conclude that the resident was experiencing falls if he was frequently found on the floor, and exhibited lesions on his body. Moreover, I consider flippant Petitioner's counsel's attempt to draw a parallel between his practice of sitting on the floor to watch TV and the resident being found on the bathroom floor near a puddle of urine.

On cross-examination of Ms. Alden, Petitioner insinuated that no wrongdoing could be attributed to the facility because R44 had a history of ignoring staff requests to wait for assistance with ambulation. Petitioner posed the question in the following fashion:

Q: He had a history of ambulating by himself. He had a history of ignoring staff requests for ambulation without assistance, didn't he?

A: I don't recall.

Q: You don't remember reading that. How convenient.

Tr. 267.

From the questioning cited above, Petitioner concludes that the surveyors overlooked, on their direct examination, that R44 had a history of ignoring staff requests that he wait for assistance before ambulating. Ironically, it was Petitioner that overlooked Ms. Alden's testimony on direct examination where she stated that "the resident had a long history of falls and attempted to ambulate by himself." Tr. 94 (emphasis added). See also Tr. 105. On this point Petitioner "doth protest too much" because it was that knowledge of the resident's history of attempting to walk unassisted that should have created a sense of heightened awareness in the facility, and resulted in the appropriate supervision to prevent accidents. The resident's proclivity for unassisted ambulation, coupled with his dementia and fractured hip, was more than sufficient to alert the facility that it was a gross mistake to discontinue the resident's use of the body alarm on March 17, 1999. I am not impressed by Petitioner's suggestion that a body alarm is of no use because it does not prevent falls. Tr. 268. Of course, a body alarm is no more capable of restraining a resident than a fire alarm is capable of preventing a fire from starting. But what are alarms for? Simply put, as Ms. Alden stated, a body alarm is a safety device that would alert staff that a resident is getting up and trying to ambulate. Tr. 269. She added that a body alarm does not necessarily have to be ordered by a physician. The alarm could be applied as a nursing intervention. Tr. at 269. Thus, it was not necessary to wait for a physician to order reinstatement of R44's body alarm. To be sure, there is no evidence that it was discontinued on a physician's order. No showing has been made that a medically reasoned decision was reached on March 17, 1999, that R44's fractured hip and dementia had improved to the point of allowing for unassisted ambulation.

b. Resident number 53 (R53)

The facility failed to provide R53 with adequate assistance and supervision by not making available a physician-ordered mattress wedge to prevent her from sliding off the bed, and by not positioning a call light within safe reach. HCFA Ex. 3, pp. 53, 54.

The surveyors found that R53 was assessed on March 18, 1999, as requiring extensive assistance for activities of daily living, and was described as confined to bed or in a wheelchair. On May 12, 1999, the facility staff confirmed that the resident's mattress had a sliding effect, and the side rails on the bed were one-half rails that allowed the bottom half of the bed to be completely open. The clinical record revealed that on May 3, 1999, the resident was found sitting on the floor. On May 6, at 7:00 p.m., she was found with her right leg hanging out of the bed, and later, kneeling on the floor. On May 10, 1999, at 2:00 p.m., the resident was found lying on the floor on her back, next to the left side of her bed, after having slid off. To prevent the resident from sliding off her bed, the physician had ordered a wedge cushion to the left side of the bed on May 10, 1999. A physician's order of May 12, 1999, was written for a body alarm at all times to monitor unassisted transfer. From May 12-14, 1999, it was observed that no wedge had been placed on the left side of the bed, and the call light was placed on the floor, out of the resident's reach.

c. Resident number 72 (R77)

CMS did not establish a prima facie case to show that Petitioner was out of compliance regarding its duty to provide R77 with adequate supervision and assistance devices to prevent accidents. HCFA Ex. 3, p. 54.

The surveyors found that R77 had a diagnosis of dementia, unsteady gait, and glaucoma. Although the resident was incontinent and on anti-anxiety medication, the surveyors noted that no assessment for falls had been made. On April 24, 1999, the resident was found on the floor after which she complained of back pain and required six days of hot packs. HCFA Ex. 3, p. 54.

Although CMS contends that no assessment for falls had been made, it concedes that R77 was provided with a wheelchair. Furthermore, the need for assistance with ambulation based on incontinence and the taking of anti-anxiety medication is tenuous. Nonetheless, by making available a wheelchair to R77 the facility implemented an appropriate intervention to prevent accidents and provided an assistance device. CMS provided no evidence that would lead to the conclusion that the circumstances surrounding R77's fall were due a failure on the part of the facility to provide proper care. Ms. Alden's testimony in that regard was speculative. She added that a wheelchair would have been a proper intervention. However, one was provided by the facility. Tr. 126, 127.

d. Residents 23, 32, and 37 (R23, R32, and R37) Petitioner failed to provide R23, R32, and R37 with adequate supervision and assistance devices to prevent accidents. HCFA, Ex. 3, pp. 47-49.

R23 was assessed as non-ambulatory due to right side contractures and increased weakness. It was noted that the resident had a history in March 1999 of a fall to the floor, when he was left unsupervised. On May 1, 1999, the nurses documented that R23 was found on the floor with a bleeding gash on the left temporal area, a hematoma on the left cheek bone, and a skin tear on the left arm. The nurses also documented that on May 4, the resident complained of left hip pain and exhibited a bruise with swelling.

A care plan written on August 20, 1998, to address the risk of falls had interventions that included keeping a call light within reach, and a body alarm at all times. On May 12, 1999, the surveyor noted that the body alarm had a beep that was inaudible outside the resident's room. The following day, the surveyor observed the resident in bed without a call signal within reach. At that time, R23 exhibited a large purple bruise on the left shin with a raised hematoma.

R32 had a history of falls from the bed and chair in December 1998 and January 1999. She was designated as "high fall risk." This meant, according to nursing, that she was to be supervised in the dining area during the day. Nonetheless, on April 7, 1999, at 11:15 a.m., the resident was found on the floor complaining of right wrist pain, and on April 18, at 2:45 p.m., she was found on the floor yelling for help with a cut on the bridge of her nose.

On April 22 and 26, 1999, the nurses documented several additional falls. In spite of all these falls and injuries, on May 18, 1999, the resident was observed in bed without a call signal.

R37 was assessed as requiring extensive physical assistance with position changes, and was at risk of falls due to loss of balance, cerebral vascular accident, and poor decision-making ability. Care-planned interventions included the use of two half side rails. On May 1, 1999, the resident slid to the floor from the bed after the aide left him alone with the side rail down.

I find that with respect to R23, R32, and R37, CMS amply established a prima facie case that Petitioner did not comply with 42 C.F.R. § 483.25(h)(2).

The record is unequivocal that R23 as well as R32 suffered actual harm due to Petitioner's failure to provide adequate supervision and assistance devices to prevent accidents. To illustrate, R23 suffered injuries to the left temporal area, cheek bone and left arm on May 1, 1999, requiring medical attention that included sutures. HCFA Ex. 13, p. 55. Another accident on May 4^th resulted in a bruised shin. Tr. 413.

Likewise, R32 suffered repeated falls in April 1999, due to Petitioner's failure to provide adequate supervision and assistance devices to prevent accidents. This is evidenced by a fall on April 18, 1999, when she suffered a cut on the bridge of her nose.

These are residents whose care plans called for fall prevention interventions, yet the facility provided no evidence at the hearing regarding measures taken to protect them from falls. CMS, on the other hand, provided evidence to show that a care planned intervention, such as use of a body alarm and call light were not always made available or placed within reach.

In regard to R37, the evidence shows that he slid to the floor from his bed when an aide left him unattended with the side-rail down. No consideration was given to the fact that the physician had ordered side rails to prevent that type of incident. Petitioner attempts to blur the issue by stating that Ms. Truett, the surveyor could not be sure whether the resident slid or fell from the bed. For purposes of showing that Petitioner did not properly provide supervision to R37, and did not employ assistance devices as ordered by the physician, such distinction is irrelevant. See P. Br. at 9.

Other than this inconsequential argument in reference to this portion of Ms. Truett's testimony, Petitioner presented no evidence or persuasive argument in order to satisfy its legal requirement to rebut CMS's prima facie case of failure to comply with 42 C.F.R. § 483.25(h)(2).

4. Infection control (F 441)

Resident's 62, 74, 32, and 31 (R62, R74, R32, and R31) Petitioner failed to ensure that the infection control program was implemented in a manner that would prevent the potential spread of infection in the facility. HCFA Ex. 3, pp. 56-59.

42 C.F.R. §483.65 (a)(1)-(13) requires that the facility establish an infection control program under which it investigates, controls, and prevents infections.

On May 14, 1999, Ms. Alden, observed R62 during a treatment by the nurse to a stage III pressure sore on the coccyx and left buttock. At the onset of the treatment, the resident had visible bowel movement oozing from her rectum. She repeatedly indicated that she needed to be toileted. Nonetheless, the nurse continued with the treatment. The nurse opened the container of debriding cream and applied it to the centers of the yellow, bloody coccyx and left buttock with gloved hands. After the application, she placed the contaminated tubes directly on the resident's overhead table.

On May 12, 1999, Ms. Alden observed R74 with an open bloody sore on his right buttock. The nurse applied cream to the area without covering it with a dressing. The resident had no incontinence brief or underwear on. The staff removed his outer sweat pants and placed them on the overhead table of his roommate (R75). At that point, another staff member entered the room and placed the resident's sweat pants on R75's bed. She then wiped off a wet area on the table with a paper towel and placed R75's supper on the table top. This resident had been identified by the facility as being treated for a parasite skin infection. Subsequent to this incident, on May 17, R75 was reported, as per the clinical record, to have complaints of itching to the upper arm and chest. The documentation attested to the resident having a red, round, raised rash with a few areas noted to have small pustule centers. The physician prescribed a topical lotion.

R32 was observed by Ms. Truett, on May 13, 1999, during toileting and incontinence care. The attending nurse aide picked up a wash cloth from the floor of the bathroom and used the cloth to wash the resident.

On May 13, 1999, Ms. Truett observed R31 during incontinence care. A nurse aide removed an incontinence brief that was heavily soiled with urine and feces. While removing the brief, her gloves became visibly soiled with incontinence material. Without removing her gloves, the nurse aide opened the resident's dresser, removed a bottle of powder and opened the privacy curtain. The aide also placed soiled linen on the resident's dresser, and brought soiled material in contact with the resident's personal possessions.

Ms. Alden testified that R62's medicated cream was applied to the resident's wound in close proximity to the oozing stool from her rectum. Furthermore, the tube of medication, which came in contact with the nurse's gloved hands that had been in contact with the wounds, and near the stool, was placed on the resident's bed table. Tr. 29. Ms. Alden pointed out that when using a debriding cream it is ineffective, if the wound is not cleaned properly, and if there is a chance that the resident's stool may become involved with the cream. Such action puts the resident at risk of a wound infection. Tr. 130. In Ms. Alden's opinion, the appropriate thing to do in a situation such as the one under consideration is to stop the treatment and continue after the resident has had the bowel movement - that would be the proper way to handle the situation not only because of the potential for contamination and infection in the wound, but also to preserve the resident's dignity. Tr. 132.

Ms. Alden stated that it was inappropriate for the staff to apply cream to R74's wound without applying any dressing. She also found it potentially harmful to place R74's sweat pants on his roommate's table and then on his bed. She explained that fluid from the opened sore could get into the pants and spread to the table and bed. Moreover, the pants should not have come into contact with any of R75's personal effects because R75 was being treated for a parasitic infection called scabies,⁽¹²⁾ which is highly infectious and spreads by contact. Tr. 135.

Ms. Alden noted also that the facility's records described R75 as an 85 year old male diagnosed with scabies and under treatment with Ibermectin and Kwell. Tr. 136. She added that other residents had been diagnosed with this condition and that it had been an ongoing problem at the facility. Tr. 138, 139.

Petitioner presented no evidence to contradict CMS's showing of a prima facie case that the facility was in violation of 42 C.F.R. § 483.65 (a)(1)-(13). The evidence reflects that the facility's inappropriate practices promoted the spread of infection rather than ensuring that an infection control program was implemented in a manner that would prevent the potential spread of infection. The only argument offered by Petitioner regarding the deficiency contained in F 441 is to the effect that the surveyor sensationalized the appearance of a deficiency when none was present. Petitioner adds that although one resident was diagnosed with scabies and three others were treated for the condition, the surveyors did not really know whether there was any spreading of scabies. P. Br. at 14.

Petitioner fails to understand the nature of the charge. The imposition of a remedy by CMS as to this tag is not grounded on a claim that there was spread of scabies in the facility. What is at issue here is the facility's failure to ensure that the infection control program was implemented in a manner that would prevent the potential spread of infections. Therefore, the operative word is potential. It is not relevant whether an actual spread of infection occurred or not.

On cross-examination, Petitioner brought out that on May 14, 1999, Dr. Alan Burwinkel noted that R75 was status post scabies and was to be placed on observation only. Petitioner thus concludes that if Dr. Burwinkel had a concern that the resident's scabies was still infectious or there was risk of transmission, he would have ordered treatment to continue. Tr. 574; HCFA Ex. 10, p. 129. This reasoning overlooks, however, that the incident involving the commingling of the personal effects of R74 and R75 with contaminated material took place on May 12. In this regard, Petitioner produced no evidence to show that R75's scabies condition on May 14, was identical to his condition on May 12. Additionally, the surveyor found that on May 17, 1999, at 11:30 p.m., the clinical record revealed that R75 was complaining of itching to the upper right arm and chest. Documentation also stated that the resident had a red, round, raised rash with small pustule centers. The physician gave a new order for a topical lotion. The resident's symptoms on May 17 were consistent with the surveyor's description of how scabies manifests itself. It would appear, then, that on the 14^th of May, R75 was not fully out of the woods concerning his parasitic condition. HCFA Ex. 3 at 58. Besides, the carelessness displayed by Petitioner on May 12^th, cannot be excused based on a chart entry made on May 14^th. The knowledge Petitioner possessed on May 12^th was that the resident was still being actively treated for scabies, and Petitioner should have acted accordingly.

Finally, Ms. Truett testified to gross mishandling of contaminated matter and exposure of residents to the potential spread of infections. This was exemplified by her description of the deficiencies involving R32 and R31. See Tr. 431 and HCFA Ex. 3, pp. 58, 59. Again, Petitioner presented no evidence to refute HCFA's prima facie showing that Petitioner was in violation of the requirement to implement an infection control program. Thus, CMS's offering stands uncontradicted.

5. Quality of Care (Tag F 309)

42 C.F.R. § 483.25 requires that 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.

a. Resident numbers 39, 55, (R39, R55)

(1) The facility failed to ensure that necessary care and services were provided to R39 in accordance with assessed care plan needs.HCFA, Ex. 4, pp. 3-6.

(2) CMS failed to establish a prima facie case that the facility failed to provide R55 with necessary care. Id.

R39 was assessed on May 14, 1999, to require extensive physical assistance for all care. Care-planned interventions included weekly skin assessment, bilateral leg wraps changed every five days, and a wheelchair "foot buddy" with footrests. Nursing notes document that on May 16, 1999, there was blood seeping under the left leg wrap. When the wrap was removed a 3 inch skin tear was exposed. The facility implemented sleeve dressings at all times on June 17, 1999.

On July 8, 1999, the resident was observed at 7:00 a.m. sitting in a wheelchair without protective sleeve dressings. The resident's feet were on the floor and there were no foot rests nor foot buddy on the wheelchair. The protective gauze dressings on both lower legs were taped and dated June 29, 1999. According to the nursing documentation, the dressings were to be changed on July 5.

Resident 55⁽¹³⁾ had diagnoses of chronic venous insufficiency and deep vein clotting. The treatment regimen included use of sheepskin protectors for status ulcers and leg elevation. On July 7, 1999, R55 was observed without lower extremity support or elevation. According to the record, this type of care was discontinued on July 9^th, due to the resident's refusal and poor cooperation. However, on July 8^th, the resident was observed in the wheelchair with both feet elevated on the foot rest. The licensed professional physical therapist was observed on July 9^th, instructing the restorative aide in proper range of motion exercises and positioning for the resident. R55 cooperated with the therapist and did not refuse the care provided.

Ms. Truett testified that on July 8, 1999, she observed R39 sitting in a wheelchair without protective sleeve dressings and no foot rests and no foot buddy. She also noted that the protective gauze dressings were taped and dated June 29, 1999. Ms. Truett explained that the purpose of dating the dressings is to monitor the assessment schedule. Tr. 450-451. R39 was on a five-day schedule, and the record reflected that she was due for a dressing change on July 5, 1999. However, Ms. Truett observed on July 8, that no dressing change had taken place since June 29. Tr. 452. On July 8, the dressings were soiled, and rolled up at the edges. Tr. 453. When the dressings were removed, multiple scabbed and bruised areas in the lower extremities were evident. In addition, two raised, blood filled areas, not previously identified in the clinical record, were evident on the inner left leg. R39 was on a Tuesday and Friday bathing schedule. Consequently, the only inference I can draw from the filthy dressings dated June 29^th, as observed by Ms. Truett on July 8^th, is that R39 was not even being bathed as scheduled. Tr. 452; HCFA Ex. 18 p. 42. The very last entry in the nurses' notes, stated that a skin assessment was performed, and it was initialed. That, however, is not possible in view of Ms. Truett's uncontradicted testimony that on July 8, R39's dressings still had a June 29 date marked on them. If the date of June 29 appearing on the dressings was not sufficient, surely the rolled up and filthy aspect of the dressings would be telling enough of the facility's dereliction in providing necessary care to R39.

Petitioner's only response to this deficiency is that the ulcer exhibited by the resident, was the result of the progression of the vascular disease. P. Br. at 14. In this respect, Petitioner overlooks Ms. Truett's testimony to the effect that not changing a resident's dressings according to the physician's schedule could result in a worsening of the skin condition or skin breakdown. Tr. 453. In the specific case of R39, lack of proper monitoring failed to discover deterioration in the resident's skin condition. Multiple scabs, bruised areas, and blood-filled areas in the lower extremities were not timely treated.

I find that any undesired progression in the vascular condition of R39 is more likely than not attributable to Petitioner's failure to comply with the requirements of 42 C.F.R. § 483.25.

Ms. Alden testified that although the physician had ordered that R55 maintain leg elevation to assist with her lower extremity blood flow problem, she observed twice on July 7, 1999, that R55 sat on the wheelchair with no support and no leg elevation. Tr. 148. Petitioner argues, and CMS concedes, that the resident was uncooperative and refused treatment. P. Br. 14. However, CMS contends that the resident was observed on July 9, 1999, cooperating with the licensed physical therapist and accepting treatment. CMS br. at 16; Tr. 156.

All that is shown here is that a licensed physical therapist managed to deal with an uncooperative resident. CMS did not advance sufficient evidence to justify a conclusion that the facility failed to maintain support and leg elevation on July 7 and 9, 1999, for a reason other than the resident's unwillingness to cooperate. Although mere evidence that a resident has been uncooperative is insufficient to justify lack of proper care, the record does show that the facility brought to bear some means to deal with the resident's unwillingness to accept intervention.

6. Pressure Sores (F 314)

Residents 55 and 11 (R55, R11).

The facility did not ensure that R55 and R11 received the necessary treatment and services to prevent avoidable pressure sores, promote healing, prevent infection, and prevent new sores from developing. HCFA Ex. 4, pp. 9-12.

42 C. F. R. § 483.25(c) requires that the facility ensure that a resident who is admitted without pressure sores does not develop them, unless the individual's clinical condition demonstrates that they are unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing.

R55 had two avoidable pressure sores on her right buttock. The resident was observed on July 7, 1999, in a wheelchair for prolonged periods without position changes. At 4:00 p.m. that same day, the resident was wheeled to the shower and transferred to a hard plastic shower chair. During transfer two bloody areas were noted on the sheet the resident sat on. She complained of discomfort while seated on the plastic chair for more than one hour. Although on July 7, 1999, a topical cream was applied to the two open sores, no mention of their existence was made in the clinical record. As a result, on July 8, 1999, the nursing staff responsible for the resident stated they were unaware the resident had any sores.

R11 had diagnoses of sepsis, dementia, dehydration, depression, and right hip fracture. She was incontinent and totally dependent on staff for toileting. This made her a high risk for skin breakdown. Care-planned interventions included a special pressure relief pad for the wheelchair, repositioning every two hours, and incontinence care every 2 to 3 hours.

On July 8, 1999, an immediate needs care plan identified an open sore on R11's right buttock due to incontinence.

On July 9, 1999, at 6:26 a.m., the resident was not checked for incontinence before being transferred to a wheelchair that did not have a pressure relief device. The resident remained in the wheelchair without repositioning, or incontinence care, until 10:15 p.m.

The survey findings in the case of R55 and R11 clearly reflect that the facility was not taking aggressive action to prevent pressure sores or provide care planned interventions to promote healing of pressure sores. This was corroborated by surveyor testimony. Tr. 162-178, 460-467.

Thus, CMS has established a prima facie case that Petitioner was in violation of 42 C.F.R. § 483.25. Petitioner failed to rebut CMS's showing by a preponderance of the evidence. In fact, Petitioner did not dispute any of the evidence presented by CMS regarding this deficiency.

7. Incontinence Care (F 316)

Residents number 59, 4, 5, and 36 (R59, R4, R5, and R36). The facility failed to provide residents who were incontinent of bladder appropriate treatment and services to prevent urinary infections and to restore as much normal bladder function as possible. HCFA Ex. 4, pp. 12-15.

42 C.F.R. § 483.25(d)(2) requires that a resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary infections and to restore as much normal bladder function as possible.

R59 had a history of treatment for bacterial urinary tract infections, and was assessed on April 13, 1999, as incontinent of urine. She was observed on July 8, 1999, from 7:30 a.m. until 10:00 a.m. in her wheelchair. At 10:00 a.m., she was transferred to her bed where it was noted that her sweat pants were visibly wet on the crotch. The staff removed a heavily soaked, foul smelling, incontinence brief from the resident. The resident's buttocks were observed to have multiple red areas with blisters covering the entire area where the brief was removed. Two of the areas on the left buttock had open bloody centers.

R4 was assessed on April 20, 1999, to require assistance with toileting and bladder incontinence. She had a history of bacterial urinary tract infections. Care-planned interventions included keeping the resident clean and dry. She was to be checked every 2 to 3 hours.

At 6:30 a.m. on July 9, 1999, the resident was observed in the dining room where she remained until 9:15 a.m. She then propelled her own wheelchair down the hall, where she remained until 9:55 a.m. without being checked or provided incontinence care. At that time a nurse aide transferred the resident to bed and removed a heavily soiled and foul smelling incontinence brief that had the time of "5:35 a.m." written on it.

R5 was assessed as occasionally incontinent of bladder and to require extensive assistance with toileting. The resident had a bacterial urinary tract infection on June 6, 1999. Care planned interventions included taking the resident to the bathroom before and after meals, every 2 hours, and on request. No perineal care was provided on July 8, 1999 after toileting. On July 9, it was observed that assistance with toileting before and after meals was not provided as called for in the care plan. When the resident was belatedly toileted on that day, the nurse did not cleanse the urine and feces from the resident before applying an incontinence product and dressing the resident. Thus, care was not provided to prevent urinary tract infections.

R36 was assessed on May 18, 1999, as occasionally incontinent of bladder and to require extensive assistance with toileting. She had a history of urinary tract infections. Her care plan included toileting every 2 to 3 hours, and perineal care after incontinence.

On July 8, 1999, the resident remained in the dining room from 7:20 a.m. until 9:38 a.m. when she was wheeled to the bathroom for toileting. At that time, the nurse removed a heavily soiled incontinence product. The urine was observed to be dark and foul smelling. Perineal care or cleansing was not provided prior to the application of a new incontinence product and dressing.

Based on surveyor observations and record review, and testimony at the hearing, CMS established a prima facie case that the facility failed to ensure that each resident with an incontinent bladder received appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible. HCFA Ex. 4, pp. 12-15; Tr. 180-184. 470-480.

Petitioner has presented no evidence to refute CMS's prima facie case by a preponderance of the evidence. For the most part, Petitioner's defense addresses the reference in the record to R59's refusal to be toileted and showered, and her abusiveness of staff. Additionally, Petitioner contends that the facility promptly changed the resident when she was noted to be wet and that the surveyor could not account for the volume of urine collected in the incontinence pad.

I find that a resident's refusal to be cared for is not an excuse for abandonment of the facility's duty to provide for the well-being of that resident. In the case at hand, the facility produced no evidence regarding a plan for dealing with the resident's refusal. No professional intervention or family involvement was brought to bear in dealing with the situation. Nonetheless, on July 8, 1999, when the surveyor was present to observe the type of incontinence care that was being provided, there was no evidence of the resident's lack of cooperation. The facility's lack of aggressive approach to incontinence care for R59 was evident in the surveyor's observation on July 8, 1999, that her buttocks revealed multiple red areas with blisters entirely covering the part where the brief was removed. Petitioner also overlooks and fails to address the two areas on the left buttock that were open with bloody centers. See HCFA Ex. 4, p.13. These findings are more telling of the cumulative effect of the facility's failure to provide necessary incontinence care to this resident, than a report of second by second observations by the surveyor. Of course, Petitioner's reasoning that virtually no time elapsed from the time the surveyor observed the resident to be wet until she was changed, is wide of the mark. Although the time of the previous change is unknown, it is an established fact that the surveyor observed the resident from 7:30 a.m. until 10:00 a.m. on July 8, 1999. During that time, no one from the facility's staff went to check on the resident. That is the significant matter to consider. The logical corollary to Petitioner's reasoning is that if an incontinent resident is not visited by staff for 5 hours, and after that lapse of time, they notice the resident to be in need of incontinence care and provide such care immediately, then that would be evidence of compliance. The reasoning is certainly flawed. Petitioner's argument that the surveyor could not testify to the rate or volume of the resident's urine discharge is not worthy of comment.

The only other argument advanced by Petitioner regarding the deficiency at tag 316 is that the surveyor was uncertain as to the amount of time that the resident's diaper was wet or soiled. P. Br. at 13. Again, Petitioner ignores that R59's brief was marked "5:35 a.m." and was changed at 9:55 a.m. It is absurd to even ask the surveyor how much time transpired from when the resident became wet or soiled until she was changed. There is no way for the surveyor to know that. On the other hand, it is just as plain that the care plan called for incontinence checks every 2 to 3 hours. The facility was unable to produce evidence that it made the required checks between 5:35 a.m. and 9:55 a.m.

8. Resident Transfers (F 498)

Residents number 4, 39, 5, 11, and 59 (R4, R39, R5, R59).

The facility failed to ensure that nurse aides were able to demonstrate competence in the skill of resident transfers. HCFA Ex. 4, pp. 23-28.

42 C.F.R. § 483.75(f) requires that the facility must ensure that the nurse aides are able to demonstrate competence in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.

R4 was 102 years old and assessed with fragile skin. She had a history in March and June 1999 of bruises of unknown origin to the extremities. Care-planning for skin integrity included an intervention for safe transfers using a gait belt.

On July 3, 1999, nursing notes documented that the resident was standing at the handrail in the bedroom while a nurse provided incontinence care. After care was completed, blood was noted on the resident's right arm. A nursing assessment revealed a 6 by 3 inch gaping laceration, one inch in depth, in the right forearm. A 2.5 by 1.5 centimeter skin tear was noted on the left elbow, and a 4 by 2 centimeter skin tear was noted on the right elbow. The resident required transfer to a hospital, and a plastic surgeon closed the laceration with 30 sutures. Subsequent to that incident, on July 8 and 9, 1999, the surveyors observed improper transfer assistance being provided to R4.

R5, R39, R11, and R59 were assessed with fragile skin and in need of extensive physical assistance. The surveyors observed on July 8 and 9, 1999, that gait belts were not utilized for transfers as required. Nurse aides improperly lifted the residents by placing their arms under the residents' axilla.

By utilizing improper transfer techniques, Petitioner caused actual harm to residents in some cases, and, in others, put them at risk of injury.

In the particular case of R4, she suffered actual harm when being transferred and handled for incontinence care. HCFA Ex. 17, pp. 133, 134. Incontinence care was being given while the resident stood at her bedside at the handrail in her room. At that time, a gaping laceration was noted in the resident's right arm, from which blood flowed. Surgical repair required 30 sutures. Tr. 483-487. Ms. Truett testified that the handrail at which the resident was standing exhibited blood and skin fragment. Tr. 487. It is reasonable to conclude that since the bleeding wound was evidently fresh, and presented itself at the time of transfer and handling for incontinence care, that the injury occurred in that process. Furthermore, the resident was a very fragile, non-weight bearing 102 years old person. HCFA Ex. 4, p. 24. She was, thus, totally dependent on the facility for mobility and care. Consequently, I find that the injury of July 3, 1999, resulted from the facility's lack of proper assistance and supervision in the transfer and handling of R4.

R5, R39, R11, and R59 were placed at risk of injury due to employment of improper transfer techniques. CMS has established a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.75(f). The facility has not come forward with evidence to contradict CMS's showing of lack of substantial compliance. As a result, it has failed to meet its burden of overcoming CMS's prima facie case by a preponderance of the evidence.

C. CMS's determination of immediate jeopardy is not clearly erroneous for the period beginning April 10, 1999, and continuing through May 16, 1999 because Petitioner failed to comply with the requirements of 42 C. F. R. § 483.25(h)(1) at the immediate jeopardy level. However, the determination is clearly erroneous as applied on May 17-20, 1999.

I have determined that Petitioner was not in substantial compliance with 42 C.F.R. §483.25 (h)(1) from April 10, l999, to May 20, 1999. I must now consider whether CMS's determination of immediate jeopardy is clearly erroneous. 42 C.F.R. § 498.60(c)(2). Koester Pavilion, DAB No. 1750 (2000).

The unrebutted evidence presented by CMS shows that R11 was very dependent due to several severe conditions. In addition, she suffered from aphasia, and thus lacked the ability to cry out for help. She was placed in a bed with unpadded half side rails that left a 4 to 5 inch gap between the mattress and rail. All of these factors militated against the resident and placed her at high risk of entrapment. After R11 became entrapped on April 10, 1999, the facility failed to take prompt action to prevent further accidents of that nature. Petitioner knew or should have known that in an entrapment situation, the resident's frail condition, combined with her aphasia could result in chest compression, suffocation, or even death. The potential for entrapment and the inability of the resident to extricate herself were real concerns ignored by the facility. Pertinent to this is Ms. Truett's testimony regarding her personal knowledge of residents dying in side rails in nursing homes. She expressed it in the following terms:

My general knowledge is that every time it happens that I am aware of, the nursing home is devastated. They don't expect it. They don't think it can happen to them. Residents who die in side rails are typically your more de- bilitated, confused, not your mobile people.

Tr. 395.

After the resident became entrapped on April 10, 1999, the facility failed to take prompt action to prevent further accidents of that nature. In fact, it was not until R11 slid down from her bed on May 14, 1999, that Petitioner implemented any type of intervention.

On cross-examination of Ms. Truett, Petitioner impliedly asserted the defense that the resident was not found to have had any injuries as a result of the entrapment incident of April 10, 1999. Tr. 543. Although CMS appeared to concede that R11 suffered no apparent injury, it is also true that the clammy aspect of her skin and mottled extremities spoke clearly of the distressful experience she had encountered. Beyond that, it is well settled that the regulation does not require any finding of actual harm to justify a determination that immediate jeopardy exists if the risk is imminent or serious enough. Immediate jeopardy is defined in the regulations as a situation in which a provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 488.301. Thus, as in the present case, the existence of a high risk for entrapment with the potential for chest compression, suffocation, or death, satisfies the regulatory requirement of imminent danger, and therefore, supports a finding of immediate jeopardy; however, not for the entire time period CMS determined.

As was stated in Wellington Specialty Care & Rehabilitation Center, DAB CR 548 (1998):

. . . . side rails can be dangerous to residents of long term care facilities. There exists a risk that some residents under certain circumstance may suffer injuries from side rails . . . on occasion, individuals have become wedged in the gaps between side rails, resulting in injuries or death to those individuals. The dangers posed by side rails impose on long-term care facilities a duty to assess and address the risk of using side rails . . . .

Id. at 9. In that same decision, the ALJ went on to say that:

On August 21, 1995 the Food and Drug Administration (FDA) sent an "alert" to hospitals and long-term care facilities which warned them of the dangers that bed side rails posed . . . This alert stated that since January 1990, the FDA had received 102 reports of incidents involving entrapment of individuals in hospital bed side rails. The FDA noted that it had received reports of 68 deaths, 22 injuries, and 12 entrapments without injuries occurring in hospitals, long-term care facilities, and private homes . . .

Id.

Petitioner has advanced no cogent argument to persuade me that CMS's determination of immediate jeopardy is clearly erroneous. Its argument that a 10-day delay by the surveyor in advising the facility of the imposition of immediate jeopardy is unavailing.

Ms. Truett testified that she learned of R11's side rail entrapment on May 12, 1999, and continued the survey until its conclusion on May 19^th. It was not until she concluded the survey, that she was in a position to assess all of the information that had been gathered. Ms. Truett explained that upon returning to her office and reviewing the information, she realized that there was no other alternative but to cite the facility at the immediate jeopardy level. After obtaining her co-team member's concurrence, she discussed the matter with the assistant supervisor responsible for the facility. Tr. 400.

Notification was given to the facility at noon on May 20, 1999, that is, within a 24-hour period after conclusion of the survey. Petitioner claims that there was a delay regarding notification of the existence of immediate jeopardy. However, it fails to express what legal consequences, if any flow from that. Moreover, Petitioner does not contend that it was prejudiced in any way. It is not my interpretation of these circumstances that if Petitioner had been told on May 12, 1999, that an immediate jeopardy violation had been found, it would have proceeded with a greater measure of diligence toward correction. The record shows that the facility was first alerted to a deficiency regarding entrapment of R11 on May 12, 1999, and it was not until after the resident slid from her bed on the 14^th of May that the facility began to take earnest steps to correct the situation. First, the facility ordered a therapeutic Roll Guard mattress on May 16, 1999, and then instituted temporary measures by inserting wedged pads under the resident's mattress. HCFA Ex. 15, p. 20. From the foregoing, it appears that what triggered corrective measures to prevent entrapment was totally unrelated to the notification of the existence of immediate jeopardy. Clearly, this is something the facility could have and should have done, at least contemporaneously with the April 10, 1999, entrapment incident.

In view of the foregoing, it is my conclusion that Petitioner was not in substantial compliance from April 10, 1999, through May 16, 1999, at the immediate jeopardy level. In light of the remedial steps taken by Petitioner beginning on May 17, 1999, I find that CMS's determination that the deficiency was at the immediate jeopardy level was clearly erroneous only insofar as it included May 17-20, 1999. After May 16, 1999, Petitioner continued to be not in substantial compliance with federal requirements of participation in the areas of quality of care (42 C.F.R. § 483.25), infection control (42 C.F.R. § 483.65), and administration (42 C.F.R. § 483.75). Although these deficiencies were at less than the immediate jeopardy level, some caused actual harm to residents.

D. The amount of CMP is reasonable.

Petitioner filed a motion in this matter dated June 27, 2000, and styled "Motion of Petitioner Cathedral Rock of North College Hill, Inc., DBA Beechknoll Convalescent Center to Limit the Civil Monetary Penalty." The essence of Petitioner's argument is that as a successor owner it is not liable for CMPs assessed for deficiencies cited before it took control of the facility. In the alternative, Petitioner seeks to have the CMP in this case limited to a "nominal sum." Petitioner incorporated the motion into its post-hearing brief filed October 20, 2000. P. Br. at 1. I address the affirmative issue raised by Petitioner first, and then examine whether the CMPs assessed in this case are reasonable as a matter of law.

1. CMPs transfer with a facility from predecessor owners to successors owners.

The amount of CMP I sustain, as discussed above, is $3,050 per day of immediate jeopardy from April 10, 1999 to May 16, 1999; and, $200 per day after May 16, 1999, until the termination of Petitioner's participation in the Medicare and Medicaid programs effective July 19, 1999.

Cathedral Rock took control of the facility on May 4, 1999. On May 11, 1999, a follow- up survey was conducted to surveys that had been conducted in January and March of 1999. Cathedral Rock is not related to the former operator, and all deficiencies alleged in the initial surveys stemmed from the management of Cathedral Rock's predecessor.

The history of prior compliance should be considered regardless of the change of ownership in determining the amount of a CMP, because a facility is purchased "as is" (I noted this in my Ruling issued on February 15, 2000). However, the fact that the history is relevant does not prevent the new owner from rebutting the presumption of the predictive value of the history of noncompliance in determining future compliance. That presumption might be rebutted where the new owner "cleans house". Careplex of Silver Spring, DAB No. 1683 (1999). In Careplex, the Board indicated that the ALJ could find that the facility needed no "spur" to correct its deficiencies (an underlying rationale for having the liability for CMPs carry over to the new owners). In that case, the Board found the CMP should be lowered because the presumption of the history's predictive value had been rebutted. Id. In that case, the new owners apparently took control days before the initial survey, and by the follow-up survey the facility was found in substantial compliance.

In accordance with the Board's holding regarding "successor liability" for CMPs, Petitioner in the instant case also took the facility "as is." The facts in this case show that Petitioner did not overcome the presumption that the noncompliant history of its predecessor was still relevant. The Board in Careplex suggested that a facility might "clean house" to overcome the presumption. In this case, Petitioner assumed control of the facility on May 4, 1999, and was found to still be out of compliance at the May 19, 1999, survey. Petitioner did not achieve compliance by the July 9, 1999, revisit survey. The record indicates that Petitioner did take steps to improve the facility, including staff changes and physical improvements, and these were noted by the surveyors. Tr. 64. Despite these efforts, CMS concluded from the survey record as a whole, and I agree with the conclusion, that the CMP was apparently not sufficient to spur the facility into substantial compliance, and thus the presumption of the predictive value of the facility's history of noncompliance had not been rebutted. I find that the record indicates that Petitioner allowed deficiencies to persist despite ample notice, and time, to rectify them. While the facility did take remedial steps, I find that they were insufficient to overcome its burden on this point. Accordingly, Petitioner has not persuaded me that reason exists to find the amount of the CMP unreasonable.

2. The amount of CMP imposed by CMS is reasonable.

As discussed above, I uphold CMS's determination that Petitioner was deficient at the immediate jeopardy level, although only from April 10, 1999 to May 16, 1999; therefore, the CMP of $3050 per day for each day of that period is per se reasonable as a matter of law because it is the lowest amount possible under the regulations. 42 C.F.R. § 488.438 (a)(1).

The reasonableness of the remaining CMP of $200 per day imposed for noncompliance from May 17, 1999 until July 18, 1999, turns on what factors CMS weighed in making its determination, and any proof that Petitioner offered in asserting that the CMP is unreasonable. The required factors are: (1) the facility's history of noncompliance (as discussed above, CMS appropriately considered this factor), (2) the scope and severity of the deficiencies, (3) the facility's culpability, and (4) the facility's financial condition. 42 C.F.R. § 488.438 (f).

Regarding the second and third factors to be considered, the scope and severity of the deficiencies and the facility's culpability, the record indicates that the surveyors discovered a pattern of deficiencies affecting more than one resident, and causing actual harm. The failure to adequately prevent and treat pressure sores, discussed above, was cited at the actual harm level in all four surveys, including two instances after Petitioner took control of the facility. See HCFA Exs. 3, 4. The record supports weighing the second and third factors against Petitioner; and Petitioner has not suggested what might mitigate or contradict those facts.

With respect to the fourth factor, it became evident during the hearing that the facility is a subsidiary of a corporation, which, according to the testimony of Kent Harrington, has a line of credit with its lender. Mr. Harrington also testified that there was a contractual arrangement for indemnification made with the former owners. Tr. 760-762, 767. CMS calculated that, based on Mr. Harrington's testimony, the CMP would constitute a small percentage of the facility's daily revenues. CMS Br. at 41. No evidence was introduced to confute these points; thus, the record does not indicate that payment of the CMP would threaten to close the facility.

I find the amount of the CMP reasonable as imposed.

E. CMS properly imposed a denial of payment for new admissions from June 25, 1999 through July 19, 1999.

As discussed above (at FFCL B.1 - FFCL B.8), I have found that the facility was not in substantial compliance with federal requirements from April 10, 1999 through July 19, 1999. CMS in its notice of imposition of remedies dated June 8, 1999, notified the facility that it was imposing a denial of payment for new admissions effective June 25, 1999. Because the facility did not demonstrate that it was in substantial compliance at any time prior to the date that the denial of payment went into effect, and similarly did not demonstrate substantial compliance at any time prior to the effective date of its termination, I uphold CMS's imposition of a denial of payment for new admissions from June 25, 1999 through July 19, 1999.

F. CMS properly terminated the facility's provider agreement effective July 19, 1999.

For the same reason, I uphold CMS's termination of the facility's provider agreement effective July 19, 1999. The facility failed to demonstrate substantial compliance at any time prior to the effective date of the termination of its provider agreement as set forth in CMS's notice of imposition of remedies issued on June 8, 1999, and the CMS surveys I have discussed which were completed on May 19, 1999 and July 9, 1999, amply demonstrated that the facility was not in substantial compliance. CMS was therefore authorized to terminate the facility's provider agreement. Beverly Health & Rehabilitation-Springhill v. HCFA, DAB No. 1696 (1999); Libbie Convalescent Center v. HCFA, DAB CR589 (1999).

Jose A. Anglada

Administrative Law Judge

1. The history of the surveys and notice of deficiencies are found in the notice letter sent by CMS to Mr. Larry Steele, Petitioner's administrator, on June 8, 1999.

2. The initial survey was in fact conducted on January 19, 1999. HCFA Exhibit (Ex.) 1.

3. Prior to the hearing, CMS had claimed that no request for hearing had been filed concerning the July 9, 1999, revisit survey; however, the record does reflect that such a request was received by the Civil Remedies Division on August 23, 1999.

4. HCFA Ex. 3 - Form 2567 (Transcript (Tr). 30).

HCFA Ex. 4 - Form 2567 (Tr. 160).

HCFA Ex. 8 - Chart of Beechknoll Community Second Floor Census (Tr. 33).

HCFA Ex. 10, p. 129 - Care Plan with notes (Tr. 137).

HCFA Ex. 10, p. 116 - Immediate Care Plan with notes (Tr. 404).

HCFA Ex. 11 - Report of Complaint Investigation (Tr. 439).

HCFA Ex. 13, pp. 5-8 - Resident Review Worksheet (Tr. 447).

HCFA Ex. 13, pp. 21-24 - Resident Review Worksheet (Tr. 72).

HCFA Ex. 13, pp. 25-28 - Resident Review Worksheet (Tr. 103).

HCFA Ex. 13, pp. 29-32 - Resident Review Worksheet (Tr. 51).

HCFA Ex. 13, pp. 41-44 - Resident Review Worksheet (Tr. 116).

HCFA Ex. 13, pp. 52-55 - Resident Review Worksheet (Tr. 408).

HCFA Ex. 13, pp. 56-59 - Resident Review Worksheet (Tr. 427).

HCFA Ex. 13, pp. 60-63 - Resident Review Worksheet (Tr. 119).

HCFA Ex. 14, p. 24- Surveyor Notes Worksheet (Tr. 36).

HCFA Ex. 14, p. 26- Surveyor Notes Worksheet (Tr. 43).

HCFA Ex. 14, p. 27-52 - Surveyor Notes Worksheet (Tr. 368).

HCFA Ex. 14, p. 29- Surveyor Notes Worksheet (Tr. 351).

HCFA Ex. 14, p. 31- Surveyor Notes Worksheet (Tr. 366).

HCFA Ex. 14, p. 52- Surveyor Notes Worksheet (Tr. 354).

HCFA Ex. 14, p. 53, 54 - Surveyor Notes Worksheet (Tr. 85).

HCFA Ex. 14, p. 56- Surveyor Notes Worksheet (Tr. 63).

HCFA Ex. 14, p. 61, 62 - Surveyor Notes Worksheet (Tr. 68).

HCFA Ex. 15, pp. 19-22 - Immediate Care Plan and Nurses' Notes (Tr. 384).

HCFA Ex. 15, pp. 32- Immediate Care Plan and Nurses' Notes (Tr. 342).

HCFA Ex. 16, pp. 1, 2 - Chart of Beechknoll Community Census (Tr. 435).

HCFA Ex. 17, pp. 72, 73 - Immediate Need Care Plan: Skin Breakdown and Skin

Protocol (Tr. 178).

HCFA Ex. 17, p. 74- Nurses' Notes (Tr. 213).

HCFA Ex. 17, pp. 81-86 - Immediate Care Plan: wound culture lab results;

Nurse's Notes;

Pressure Ulcer Condition Report (Tr. 206).

HCFA Ex. 17, p. 102- Nurse's Notes (Tr. 197).

HCFA Ex. 17, pp. 133, 134- Immediate Need Care Plan and Nurse's notes (Tr.

492).

HCFA Ex. 18, pp. 1-4 - Resident Review Worksheet (Tr. 185).

HCFA Ex. 18, pp. 17-20 - Resident Review Worksheet (Tr. 473).

HCFA Ex. 18, pp. 25-28 - Resident Review Worksheet (Tr. 500).

HCFA Ex. 18, pp. 29-32 - Resident Review Worksheet (Tr. 460).

HCFA Ex. 18, pp. 40-43 - Resident Review Worksheet (Tr. 456).

HCFA Ex. 19, pp. 1-6 - Surveyor Notes Worksheet (Tr. 369).

HCFA Ex. 19, pp. 8-12 - Surveyor Notes Worksheet (Tr. 370).

HCFA Ex. 19, p. 18- Surveyor Notes Worksheet (Tr. 166).

HCFA Ex. 19, p. 23- Surveyor Notes Worksheet (Tr. 170).

HCFA Ex. 19, pp. 27-31 - Surveyor Notes Worksheet (Tr. 370).

HCFA Ex. 19, pp. 32, 33- Surveyor Notes Worksheet (Tr. 186).

HCFA Ex. 19, p. 34 - Surveyor Notes Worksheet (Tr. 175).

HCFA Ex. 19, pp. 36-43 - Surveyor Notes Worksheet (Tr. 371).

HCFA Ex. 20, pp. 1, 2- Nurses' Notes (Tr. 497).

HCFA Ex. 21, pp. 18-20 - Plan of Care - ADL Direct (Tr. 519).

5. See Beverly Health & Rehabilitation-Springhill, DAB CR553 (1998).

6. The Star Chamber, so called because it originally sat in the royal palace of Westminster in a room that had stars painted on the ceiling, was a court created in 1487 by King Henry VII of England. At first, although the court functioned without a jury, it did not abuse its powers, and its proceedings were public. In later years, other monarchs corrupted the court, and it met in secret and dealt out excessive and cruel punishment. I am puzzled at Petitioner's reference to Spain. I fail to see the connection between Spain and the Star Chamber or with anything else having to do with this hearing.

7. In the end not all 43 pages of HCFA Ex. 18 were admitted into evidence.

8. At the hearing, I pointed out to Ms. Alden that it would be unfair for me to conclude that R54's position had not been changed if she were unable to observe and detect staff going into the resident's room. In its brief, Petitioner misconstrued the import of my statement. See P. Br. at 11. In the preceding portions of the witness' testimony, I had asked her some very specific questions regarding her ability to detect the entry of facility personnel into the resident's room. My questions were directed at assessing her credibility, and having her gain an appreciation of the seriousness of my role as the adjudicator. At that point in Ms. Alden's testimony where I made the observation to her, she had already testified credibly regarding her ability to observe the traffic of people in and out of the resident's room. Of course, in the case of R54, the surveyor's ability or inability to observe position changes is not wholly dispositive of the issue as to this deficiency.

9. Ms. Alden defined the stages of pressure sores as follows:

1. A stage I pressure sore is an area of redness on the skin.

2. A stage II pressure sore is an area that is either in the form of a blister, a skin breakdown, or skin abrasion, with damage to the top layer.

3. A stage III pressure sore has full thickness into the dermis, the epidermis, and the subcutaneous tissue, described sometimes as a crater.

4. A stage IV pressure sore is thicker than a stage III, presenting a wound which is necrotic, with damage to the skin, and deeper craters into the actual fascia of the skin. Tr. 65, 66.

10. There was an evident absence of communication between staff and administration as is noted below by the acknowledgment of nurse aides that they were aware of the dangerous temperature levels of the water in the facility.

11. A body alarm is a safety device that will make a loud beeping sound when the resident attempts unassisted ambulation. It is connected either to the resident or the bed, and will sound when the resident attempts to get up. Tr. 94.

12. Ms. Alden identified scabies being caused by the human itch mite. The mite is a parasite that bores into the skin and can cause rash and itch.

13. HCFA Ex. 3, p. 5, refers to R59, instead of R55. This was clarified at the hearing. See Tr. 145.