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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Ivy Woods Health Care and Rehabilitation Center, |
DATE: September 30, 2003 |
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Centers for Medicare & Medicaid
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Docket No.C-01-994
Decision No. CR1093 |
| DECISION | |
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DECISION
Petitioner, Ivy Woods Health Care and Rehabilitation Center, was not in substantial compliance with participation requirements during the period June 28, 2001 through July 9, 2001, as discussed more fully hereafter. Therefore, the Centers for Medicare & Medicaid Services (CMS) had a basis for the imposition of a civil money penalty (CMP) of $550 per day for 12 days, a total of $6,600, and that remedy is reasonable. I. PROCEDURAL HISTORY Petitioner is located in Cincinnati, Ohio and is authorized to participate in both the federal Medicare program as a skilled nursing facility (SNF) and in the Ohio State Medicaid program as a nursing facility (NF). CMS Exhibit (CMS Ex.) 1. The Ohio Department of Health (the State agency) conducted a survey (1) of Petitioner's facility from June 24, 2001 through June 28, 2001 (the June 2001 survey). CMS Exs. 2-4. The State agency found Petitioner not in substantial compliance with Medicare and Medicaid participation requirements and cited Petitioner with violation of 12 regulatory provisions that allegedly presented a risk for more than minimal harm to Petitioner's residents with the most serious deficiency being isolated incidents that resulted in actual harm but did not rise to the level of immediate jeopardy. Id. CMS notified Petitioner by letter dated July 23, 2001, that based on the June 2001 survey, it had determined to impose a CMP of $550 per day effective June 28, 2001, plus other remedies. CMS Ex. 7. The State agency decided after a follow-up survey on July 12, 2001, that Petitioner had achieved substantial compliance effective July 10, 2001, as Petitioner alleged in its plan of correction. CMS Exs. 8 and 10. CMS advised Petitioner by letter dated August 29, 2001, that enforcement remedies ended July 9, 2001, the day before the date on which Petitioner was found to be in substantial compliance, resulting in a total CMP of $6,600 ($550 per day for 12 days from June 28, 2001 through July 9, 2001). CMS Ex. 12. Petitioner requested a hearing by administrative law judge (ALJ) on September 18, 2001. The case was assigned to me for hearing and decision on October 1, 2001. A hearing was held in this case on October 21, 22, and 23, 2002 in Cincinnati, Ohio. CMS presented the testimony of Nancy E. Thompson, Patricia Whitenack, and Susan Best. Petitioner called as witnesses Nancy E. Thompson, Rhonda L. Feagin, Daniel Washington, Waleed Fadayel, Linda Vickers, and Melissa Buis. The transcript of proceedings totals 456 pages. (2) Petitioner's exhibits (P. Ex.) 1 through 10 and 12 were received as evidence. Tr. at 45. Petitioner withdrew P. Ex. 11 and it is not considered in this decision but will remain with the record. Tr. at 448. CMS exhibits 1 through 43 were admitted as evidence over Petitioner's hearsay objection. Tr. at 13-14. However, I have considered the hearsay nature of any documents in determining their probative value. CMS Ex. 44 was marked for identification but not admitted and is not considered in this decision. Tr. at 354. The Parties submitted post-hearing briefs on March 17, 2003. CMS filed a post-hearing reply brief on April 15, 2003 and Petitioner filed its reply on April 16, 2003. II. FINDINGS OF FACT AND CONCLUSIONS OF LAW
The following findings of fact are based upon the credible testimony at hearing and the exhibits admitted as evidence. Findings related to specific deficiencies are indicated by F Tag number. (Citations in analysis.)
5. The State agency decided after a follow-up survey on July 12, 2001, that Petitioner had achieved substantial compliance effective July 10, 2001, as Petitioner alleged in its plan of correction. 6. CMS advised Petitioner by letter dated August 29, 2001, that enforcement remedies ended July 9, 2001, the day before the date on which Petitioner was found to be in substantial compliance, resulting in a total CMP of $6,600 ($550 per day for 12 days from June 28, 2001 through July 9, 2001). 7. Petitioner requested a hearing by administrative law judge (ALJ) on September 18, 2001. 8. Factual findings related to F Tag 164.
III. DISCUSSION
Petitioner does not contest the reasonableness of the proposed remedy, but denies that any deficiencies existed that provide the basis for a remedy. Tr. at 284. Thus, the only issue is:
The Act sets forth requirements for long-term care facilities participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919 (42 U.S.C. �� 1395i-3; 1396r). (3) The Secretary's regulations governing SNFs and NFs participation in the Medicare and Medicaid programs are found at 42 C.F.R. Part 483. Survey, certification and enforcement procedures for providers and suppliers, including SNFs and NFs, are found at 42 C.F.R. Part 488. A SNF and/or NF must maintain substantial compliance with program requirements as set forth at 42 C.F.R. Part 483 to participate in the Medicare and Medicaid programs. If the State or CMS finds violations of Part 483 requirements, also know as deficiencies, in a facility's operation during a survey, the deficiencies noted must present no greater risk to resident health or safety than the "potential for causing minimal harm" or the facility will be found not in substantial compliance and a certificate of noncompliance will issue. 42 C.F.R. �� 488.302 and 488.330. If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in section 1819(h) of the Act (42 U.S.C. � 1395i-3(h)) and 42 C.F.R. � 488.406. The purpose of the authorized remedies is to "ensure prompt compliance with program requirements." 42 C.F.R. � 488.402(a). Remedies are applied on the basis of the scope and severity of the noncompliance found during surveys. 42 C.F.R. � 488.402(b). The factors to be considered by CMS when selecting remedies are set forth at 42 C.F.R. � 488.404. A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing remedies. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000). The Board has long held that the net effect of these regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).
CMS alleges 12 regulatory violations (also know as deficiencies) in this case that allegedly resulted in or had the potential for causing more than minimal harm to Petitioner's residents. CMS cites multiple examples in support of most of the alleged deficiencies. Petitioner's defense to the CMS allegations is based upon the weight and sufficiency of the evidence presented in this case - a fact based defense. Petitioner argues that "the testimony and evidence introduced in this action demonstrates that Ivy Woods was in substantial compliance with program participation requirements and the survey made incorrect determinations." P. Br. at 1. Petitioner also argues that either CMS failed to make a prima facie showing as to each deficiency or, if a prima facie showing was made, Petitioner "introduced more in quantity and quality of evidence than just to bring the matter to equipoise." P. Br. at 25. Petitioner asserts no affirmative defenses as to any alleged deficiency. According to decisions of the Board, CMS bears the initial burden of producing evidence sufficient to establish a prima facie case for each alleged violation of the regulations. CMS must set forth the basis for its determination with sufficient specificity for a petitioner to respond and come forward with evidence related to the disputed findings. The evidence set forth by CMS must be sufficient to establish a prima facie case that CMS had a legally sufficient basis to impose a remedy. In order for a petitioner to prevail, the petitioner must then prove by a preponderance of the evidence on the record as a whole that it was in substantial compliance with the relevant statutory and regulatory provisions or that it had an affirmative defense. Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). Petitioner asserts that if the evidence is in equipoise, then I would have to rule against CMS because it bears the "burden of proof." P. Br. at 25. However, as Petitioner also notes, where the evidence is not in equipoise, it is not necessary to resolve a case based on the allocation of the burden of proof. The United States Supreme Court has concluded that in cases subject to the Federal Administrative Procedure Act (APA) the phrase "burden of proof" as used in section 7(c) of the APA (5 U.S.C. � 556(d)) means the burden of persuasion, which must be distinguished from the burden of production (also know as the burden of going forward with evidence). Department of Labor v. Maher Terminals, Inc., 512 U.S. 267, 272 ( 1994). The Court stated the burden of persuasion is "the notion that if the evidence is evenly balanced, the party that bears the burden of persuasion must lose." Id. Little more than a year ago, the U.S. Court of Appeals for the Seventh Circuit refused to address the rule for the allocation of the burden of proof adopted by the Board in Hillman, because in the case before the Seventh Circuit the evidence was not in equipoise and Hillman was not, by its own terms, operative; and, because the Board had not addressed the application of the rule in any comprehensive manner. Fairfax Nursing Home, Inc. v. HHS, 300 F.3d 835, 840, n.4, cert. denied., 537 U.S. 1111 (2003). In the case before me, as in Fairfax, the evidence is not evenly balanced or in equipoise, accordingly it is not necessary to decide this case based upon which party bears the burden of proof. The Board's definition of the requirements for a prima facie case from Hillman is, nevertheless, helpful in resolving this case:
DAB No. 1611, at 8. Thus, CMS has the initial burden of showing that its decision to terminate is legally sufficient under the statute and regulations. To make a prima facie case that its decision was legally sufficient in this case, CMS must: (1) identify the statute, regulation or other legal criteria to which it seeks to hold the provider; (2) come forward with evidence upon which it relies for its factual conclusions that are disputed by the Petitioner; and (3) show how the deficiencies it found amount to noncompliance that warrants an enforcement remedy. In its post-hearing reply brief, Petitioner briefly alludes to the standards related to expert witness testimony. In this case, neither of the parties sought to qualify their witnesses as "experts" as that term is used in the Federal Rules of Evidence. However, Petitioner's discussion is pertinent to the extent that the argument goes to the weight or probative value to be given the testimony of the various witnesses relative to their specialized knowledge, training and expertise. Contrary to the assertions of Petitioner, CMS has made a prima facie showing and the preponderance of the evidence establishes that Petitioner was not in substantial compliance with the conditions for participation as discussed hereafter. The weight or probative value I give the evidence, either testimonial or documentary, is indicated in the discussion for each deficiency.
CMS recalled Ms. Nancy Thompson as a rebuttal witness following Petitioner's case-in-chief. Tr. at 429-445. Petitioner objected to Ms. Thompson's testimony as being improper rebuttal and then moved to strike her testimony offered as rebuttal. Tr. at 430, 432-433, 446. (4) I have now reviewed all the testimony offered in the case and conclude that Ms. Thompson's rebuttal testimony was cumulative of evidence offered in the CMS case-in-chief or constituted evidence that should have been offered in the CMS case-in-chief. Counsel for CMS did not establish a proper foundation for the rebuttal evidence and never identified what evidence offered by Petitioner was being rebutted. Accordingly, I conclude that the testimony of Ms. Thompson, offered by CMS as rebuttal (Tr. at 429-445), was not proper rebuttal and it will not be considered in the decision of this case. The motion to strike is granted.
The State agency completed an annual survey and a complaint investigation of Petitioner's facility on June 28, 2001. Deficiencies were identified by the surveyors and were recorded in the left column of the statements of deficiencies (HCFA Form 2567L or SOD) for the surveys, copies of which were admitted as CMS Exs. 2 and 3. Petitioner's plan of correction for each of the deficiencies alleged were recorded in the right columns on the SODs, copies of which were admitted as CMS Exs. 8 and 9. Petitioner alleged in its plan of correction, without admitting or denying the existence of any deficiency, that it achieved substantial compliance effective July 10, 2001. CMS Exs. 8 and 9. The State agency conducted a revisit survey on July 12, 2001 and confirmed that Petitioner had, in fact, achieved substantial compliance as of July 10, 2001. CMS Ex. 10. By letter dated August 28, 2001, CMS advised Petitioner that the State agency had found Petitioner in substantial compliance and that the only remedy that remained was a CMP of $550 per day for the period June 28, 2001 through July 9, 2001 - a total CMP of $6,600. CMS Ex. 12. Petitioner disputes each of the findings of deficiency that allegedly presented the possibility for more than minimal harm to its residents. I decline to rule on F Tag 371 and I conclude that CMS failed to make a prima facie case as to F Tag 315 and F Tag 364. However, as explained below, the remainder of the deficiencies were persuasively established and are sufficient to support the remedies imposed. Beechwood Sanitarium, DAB No. 1834, at 19 (2002). I resolve the disputes as follows:
CMS cites one incident or example in support of this alleged violation. On June 25, 2001, the surveyor observed a nurse providing care to R. 11, whose naked body was exposed to view from the hall as her gown was pulled up to her chest. The door to the resident's room was open and the privacy curtain was not closed. The surveyor alleged that another resident looked into the room, and, that when the nurse started to leave the room, the nurse saw the surveyor in the hall she returned to the room and pulled the privacy curtain. CMS. Ex. 8, at 2. Petitioner's plan of correction, (6) located in the right column of the SOD, indicates that correction is by in-service training of staff. Id. at 1-2. Sections 1819(c)(1)(A)(iii) and 1919(c)(1)(A)(iii) of the Act provide that a resident has a right to privacy with regard to accommodations and medical treatment. The Secretary has interpreted this right to include the right to privacy during personal care. 42 C.F.R. � 483.10(e)(1). The Secretary has further indicated that such privacy includes "full visual . . . privacy." 54 Fed. Reg. 5316, 5323 (Feb. 2, 1989). Thus a facility must take reasonable measures to ensure personal privacy which includes ensuring that an unclothed resident receiving personal care is shielded from the view of other residents, visitors and even staff not involved in delivering care, by means such as covers, privacy curtains and closed doors. See Price Hill Nursing Home, DAB No. 1781 (2001); The Windsor House, DAB CR1039 (2003). Susan Best, the surveyor who made the observations recorded in the SOD related to R. 11, was called as a witness by CMS. Ms. Best testified that the door to the room occupied by R. 11 was open; that from the hallway she personally observed R. 11 receiving care; that R. 11, a female resident, was exposed from her chest to her feet; that a male resident in a wheelchair stopped at the open door of R. 11's room and said "hi" to the nurse and that the nurse providing care for R. 11 neither closed the privacy curtain or door to the room while the male resident was sitting there. Tr. at 211, 246-248, 268-269. Petitioner points out in its post-hearing brief that R. 11 was comatose and her ability to perceive is unknown. Petitioner further notes that the surveyor did not know exactly what care R. 11 was receiving or how long she actually observed the resident. P. Br at 2. Petitioner cites the testimony of its witnesses that R. 11 moves her arms causing her clothing and bed clothing to move, leaving her body uncovered. Tr. at 386-387, 415-416; P. Br. at 2-3. Petitioner also relies upon the testimony of Melissa Sue Buis, a licensed practical nurse (LPN) who is a charge nurse at the facility, who testified that she did not think the surveyor could have observed a nurse providing care to R. 11 at about 6:30 a.m.on June 24, because, at that time, there was only one nurse on the unit and that nurse should have been passing medications. Tr. at 415; P. Br. at 2-3. The testimony of the surveyor who was an eyewitness to the incident carries greater weight than the testimony of Petitioner's witnesses. The surveyor testified from personal knowledge based on her observations. While Ms. Buis may have some basis for her assertion that a nurse could not have been providing care to R. 11 when alleged by the surveyor, she was not present when the incident occurred and her testimony is speculative. Ms. Buis also does not rule out that a nursing assistant or some other staff member was providing the care observed by the surveyor. The testimony of Petitioner's witnesses, that R. 11 moved so as to cause her clothing to rise and her bed clothes to move, is credible but does not address the issue of why the staff member present in the room did not pull the privacy screen and/or close the door to ensure R. 11's personal privacy. I conclude that the evidence shows that R. 11's body was exposed to view from the hallway and that Petitioner's staff did not take steps to ensure R.11's privacy by closing the privacy curtain or door or otherwise covering R. 11. Petitioner suggests, but does not specifically argue, that because R. 11 was comatose she may not have realized that others could view her naked and, thus, there was no harm. I reject this argument as the regulation does not impose upon facilities the duty to protect the rights of only those residents who can appreciate their rights. Further, the introductory passage of 42 C.F.R. � 483.10 provides that a resident has "a right to a dignified existence." Lying naked in full view of others is not consistent with personal dignity. Petitioner points to no law to support the notion that it is unnecessary for facilities to protect the rights of comatose residents or that inability of a resident to perceive a violation of his or her rights is a defense to a deficiency citation. I conclude that there was the potential for more than minimal harm to R. 11 by the violation of her right to privacy.
CMS cites two examples in support of this alleged deficiency, related to R. 40 and R. 2. CMS Ex. 8, at 3-4. (7) CMS alleges that, on June 26, 2001, the surveyor observed R. 40, during a transfer from the bed to a shower bed, repeatedly ask staff to turn the shower bed around because they were putting her in it so that her head was where her feet should be. The staff responded that they knew what they were doing and ignored R. 40's requests. Subsequently, the surveyor determined that R. 40 was correct that she had been put in the shower bed backwards. The surveyor further observed that R. 40 complained of pain in her recently broken right leg and cried while in the shower but the staff did not try to reposition the leg and commented to others in the room that R. 40 always complained like this. After transferring R. 40 back to bed and while continuing to provide personal care to R. 40, staff discussed how they had urine on their uniforms from R. 40's leaking catheter. CMS. Ex. 8, at 3. Regarding R. 2, CMS alleges that at about 8:40 a.m. on June 25, 2001, the surveyor observed staff cleaning R. 2's perineal area which was excoriated and bright red. Staff was rubbing and R. 2 was sobbing, but staff did not rub more gently or even ask R. 2 what was wrong. Petitioner's plan of correction provides for in-service training and monitoring of staff. Id. at 3-4. Sections 1819(b)(1)(A) and 1919(b)(1)(A) of the Act require that a facility "must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident." In 42 C.F.R. � 483.15, which is titled "quality of life," the Secretary promulgated a set of standards to further this statutory requirement. Subsection 483.15(a) addresses the dignity of residents and provides that a "facility must promote care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect in full recognition of his or her individuality." The regulatory history of section 483.15 provides little insight as to what the Secretary intended by this regulatory provision. 54 Fed. Reg. 5316, 5327-5328. I construe the regulation to require that a facility treat its residents in a manner and environment that is respectful and maintains or enhances the resident's sense of dignity, i.e. , the resident's sense of worth and self-esteem. (8) The gist of the CMS citation is that R. 40 and R. 2 were treated in an undignified and disrespectful manner to the extent that staff seemingly ignored the residents, their protests, their complaints of pain, and their emotional reactions and spoke among themselves as if the residents were not present. Nancy Thompson, the surveyor who observed the incident with R. 40, testified for CMS. Her testimony was consistent with the facts alleged in the SOD. CMS Ex. 8, at 3. Tr. at 61-65. Additionally, she explained how staff's failure to position R. 40 in the shower bed properly left her recently broken leg not fully supported and, therefore, more vulnerable to pain. Tr. at 64. Petitioner does not deny the incident with R. 40, as observed by Ms. Thompson, or even address the allegations in its post-hearing brief except to summarize the testimony of Ms. Thompson. P. Br. at 3-4. Susan Best was the surveyor who made the observations related to R. 2 recorded in the SOD. Her testimony was consistent with the allegations of the SOD. Tr. at 212-214. Petitioner argues, based on the testimony of its witness, Melissa Buis, that it is inconsistent that R. 2 stopped crying immediately after staff stopped rubbing her perineal area but does not deny R. 2 was crying or that staff responded as indicated by Ms. Best. P. Br. at 4. I do not find the fact R. 2 stopped crying after staff stopped rubbing inconsistent with CMS's assertions that staff should have been more gentle in cleaning R. 2. Rather, it seems reasonable that, if the cleaning was hurting R. 2, stopping the cleaning would remove the source of the pain. Petitioner also asserts R. 2 could only give simple answers to questions and often was unable to give appropriate responses. Id. Again, this fact does not contradict the surveyor's observations. There is no indication that R. 2's capacity to feel pain and respond to pain was compromised by any diminished capacity to answer questions. I have no trouble finding a violation of 42 C.F.R. � 483.15(a) given the credible testimony of both surveyors. The regulation requires that staff treat residents respectfully and in a manner to help maintain or enhance the resident's dignity. The focus of the regulation is upon the conduct of staff toward the resident and not the conduct of the resident toward the staff. Thus, even if, as Petitioner suggests, R. 40 is a constant complainer and highly manipulative, the evidence is clear to me that staff ignored her assertions that she was being put in the shower bed backwards; ignored her assertions that her broken leg, which was not fully supported because she was in the shower bed backwards, hurt; talked about her like she was not there; and discussed having urine on their clothes from her leaking catheter in front of her. These acts are not respectful and would diminish the dignity of any person, whether or not the person is manipulative. Additionally, even if R. 2 was crying for some reason other than from pain inflicted by staff, it was staff's failure to respond to the fact that R. 2 was crying that constituted the violation. This deficiency was cited by the State agency as having the potential for more than minimal harm but no actual harm. The scope and severity cited by the State is inconsistent with the facts, to the extent that the infliction of pain in both examples clearly amounts to actual harm.
The quality of life provisions require generally that a facility care for residents "in a manner and in an environment that promotes maintenance or enhancement of each resident's quality of life." 42 C.F.R. � 483.15. One of the enumerated rights is that a resident has a right to "reside and receive services in the facility with reasonable accommodation of individual needs and preferences, except when the health or safety of the individual or other residents would be endangered . . . ." 42 C.F.R. � 483.15(e)(1). CMS alleges violation of the regulation based on three examples involving R. 43, R. 40, and R. 20 and Petitioner's failure to accommodate their individual needs thereby subjecting them to potential harm. CMS Ex. 8, at 5-7. All three examples involve call lights. The SOD alleges in example 1, related to R. 43, that the plan of care required that the call light be in easy reach at all times and that R. 43 be encouraged to use the call light, but the wrong type of operating device was provided R. 43. Example 2, related to R. 40, alleges that her call light was out of reach for 50 minutes, which is contrary to the requirements of her care plan. The SOD alleges that R. 20 was observed sitting in a chair with his call light on the floor on multiple occasions on two different days. Petitioner indicates in the plan of correction that R. 43 was provided the proper call light, that staff received training on keeping call lights in reach, and there would be monitoring. Id. The evidence shows that R. 43 suffered from bilateral hand contractions and was unable to squeeze a bulb type call light device. Further, her plan of care required that her call light be in easy reach and that she be encouraged to use the light. CMS Ex. 26, at 14-15. The surveyor who made the observations related to R. 43, Vallia Jean Combs, did not testify at hearing but CMS provided her declaration. The declaration was admitted as CMS Ex. 43 over Petitioner's hearsay objection, with the caveat that the hearsay nature of the document would be considered with regard to its probative value. Linda Vickers, a staff nurse at Petitioner's facility, testified that R. 43 could use her call light and that staff monitored call light placement. Tr. at 402. According to Rhonda Feagin, Petitioner's CNA Coordinator, staff are regularly and frequently trained about positioning call lights to be accessible to residents. Tr. at 321-322. I accept the statements of Ms. Combs in her declaration as an accurate rendition of her observation that R. 43 could not use the squeeze ball call light provided to her by Petitioner. The testimony of Ms. Vickers and Ms. Feagin are not specific and do not negate or rebut Ms. Combs reported observations. I also note that Petitioner does not address the example related to R. 43 in its post-hearing brief at 5-6. Nancy Thompson made the observations recorded in the SOD regarding R. 40's call-light. She verified that on June 24, 2001, she saw that R. 40's touch pad was out of reach for about 50 minutes. Tr. at 66-67. R. 40's care plan specified that her call light was to be within easy reach and she was to be encouraged to use it. CMS Ex. 25, at 22-23. Petitioner did not present evidence to rebut Ms. Thompson's testimony. P. Br. at 5. Susan Best testified for CMS that, on several occasions during the survey as reported in the SOD, she observed that R. 20's call light was out of reach on the floor even though his plan of care required that his call light be in easy reach and that he be encouraged to use it. Tr. at 214-215. Petitioner questions Ms. Best's knowledge of the MDS form and the fact that she did not note how long R. 20's call light was on the floor in each instance. P. Br. at 5-6. However, Petitioner does not deny that Ms. Best's observations were accurate or rebut their accuracy. Further, the fact that R. 20's call light was observed to be on the floor on multiple occasions on June 24 and June 26 indicates that Petitioner needed to take some action to correct the situation. CMS asserts that these examples presented the possibility for more than minimal harm to each of the residents involved based on their conditions, a position confirmed by CMS witnesses. The evidence supports CMS's position in that the evidence shows that each of the residents had the need to be able to get the attention of staff through use of the call light, but at various times they did not have access to their call lights or could not operate a bulb type call light. Petitioner has not presented evidence to rebut CMS's evidence that the residents in question did not have access or that such access was unnecessary. Accordingly, I conclude a violation has been shown and that the violation resulted in no actual harm but had the potential for more than minimal harm.
Another enumerated quality of life requirement is that the facility must provide "medically-related social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident." 42 C.F.R. � 483.15(g); see also Milpitas Care Center, DAB No. 1864 (2003). CMS alleges that Petitioner violated this requirement in the case of 8 of 17 sampled residents, R. 32, R. 78, R. 76, R. 40, R. 2, R. 21, R. 10 and R. 20. As to these residents, CMS alleges in the SOD as follows. R. 32's records did not reflect he received social services related to discharge planning. R. 78's plan of care required social services visits at least twice monthly, and daily, if necessary, to address his depression, but such visits were not documented. R. 76 was discharged with no evidence of discharge planning with social services. R. 40 had numerous psychosocial issues, including conflict with a direct care-giver, that were not reflected in social services records. R. 2's nurse reported he needed evaluation for depression, but there was no social services intervention. R. 21 was noted to be combative with nurses and often sad and withdrawn, but there was no social services intervention. R. 10 was depressed on admission to the facility a month prior to the survey, but there was no record of any social services intervention. Finally, R. 20 was noted to frequently worry about his roommate's condition and worry he was going to die, but there was no evidence social services addressed the problem. CMS Ex. 8, at 8-11. CMS presented the testimony of the surveyors who reviewed Petitioner's records and interviewed the residents involved. The surveyors confirmed their observations during the survey as recorded in the SOD. Tr. at 68-71; 100-105; 108-110; 216-224; 265-266; 302-304. While Petitioner is critical, in its post-hearing brief, of the testimony and qualifications of the three surveyors involved in this citation of deficiency, Petitioner does not specifically rebut, either by evidence or argument, any of their testimony. I am satisfied based on their testimony that the three surveyors were well qualified as surveyors and their testimony about their observations and analysis of Petitioner's documents is credible. Further, I note that Petitioner's attack on the surveyors' qualifications and conclusions does not address cases, such as that of R. 78 and R. 2, in which its own records indicated that social services should have been provided but were not. Petitioner points to the testimony of its witness, Ms. Buis, who testified that, in the case of R. 32, it was not initially anticipated that he would be discharged and therefore no discharge planning was done. However, after a bout of pneumonia was resolved, Petitioner did find placement for R. 32. Tr. at 416. I find this testimony troublesome for if Ms. Buis is correct, then some discharge planning was done in the form of finding R. 32 a home, but no documentation has been produced by Petitioner concerning the discharge planning. The lack of documentation for the planning of the placement of R. 32 is consistent with the allegations of surveyors. It is noteworthy that, during the survey, Ms. Thompson interviewed the sole social worker Petitioner's facility. She indicated that, due to illness, she had only been working part-time for one to two hours per week and she did not have time to deal with all 75 residents. Tr. at 70; CMS Ex. 1, at 4. In its plan of correction, Petitioner noted that it continued its search for a "full-time social worker"; that the Administrator or designee would act as a social worker; that the facility had obtained a contract for an outside agency to provide social services; and that efforts would be made to timely document social services. CMS Ex. 8, at 8-9. This evidence is noteworthy as it is consistent with, and possibly explains, CMS's finding that social services were either not provided or not documented. The surveyors each expressed the concern that the failure to provide proper medically related social services could lead to the exacerbation of existing anxiety and depression or other mental impairments or the development of additional impairments. Petitioner does not offer any evidence to rebut that testimony. I conclude that this deficiency presented the risk for more than minimal harm to Petitioner's residents.
Part of the general duty to care for residents in a manner and environment that promotes maintenance or enhancement of each resident's quality of life is the specific requirement to provide a "safe, clean, comfortable, and homelike environment . . . ." 42 C.F.R. � 483.15(h)(1). The State agency and CMS allege that Petitioner failed in this duty because: (1) strong urine odors were noted at multiple times on June 24, 25 and 26, 2001; (2) a storage cabinet containing potentially hazardous materials was accessible by residents and was unlocked and unsupervised for more than an hour on June 25, 2001; and (3) a brown dried substance was noted in two different shower rooms. CMS Ex. 8, at 11-12. Susan Best was the surveyor who made the observations recorded in the SOD. She testified at the hearing and confirmed that the SOD accurately recorded her observations. She clarified that the strong urine odor was detected throughout the facility and was strong enough to "make your eyes burn." Tr. at 224. She testified that even a resident in a wheelchair could reach hazardous materials on the bottom shelf of the open cabinet. Tr. at 225-226. She also believed that the brown substance she saw in the two shower rooms was fecal material which remained for approximately three hours. Tr. at 227-228. Ms. Best admitted on cross-examination that she did not know the facilities equipment cleaning schedule, housekeeping schedule or shower schedule, but she did know that the shower room was in use during the time the feces were present. Tr. at 255-256. Rhonda Feagin, CNA coordinator and employee of Petitioner for more than nine years, testified she had not noticed a strong urine odor throughout the facility; that the facility is very clean in her opinion; and that there are regular cleaning schedules. Tr. at 316. Waleed Fadayel, the Administrator, testified that he makes the rounds of the facility and has noticed an intermittent smell of urine which is usually only in certain areas. He recalled that the urine odor was gone by the time he got to the facility during the survey. Tr. at 387. Melissa Buris testified that when there are odors, housekeeping takes care of the problem. Tr. at 419. It is not reasonable to think that a nursing facility will always be free of unpleasant odors. However, the repeated presence of strong foul odors certainly should not be tolerated due to its likely bad effect upon residents and staff. In this case, an experienced surveyor, who I have no reason to doubt, noted the presence of strong odors on three different days and at least once the odors were strong enough to make her eyes burn. Petitioner presents no evidence or argument that directly addresses the surveyor's observations (see P. Br. at 9-10) and, in fact, Petitioner never actually denies that the odors were present as alleged by the surveyor. Rather, Petitioner's evidence is that one employee did not smell anything or the odors abated after a time and the cleaning staff is good and usually takes care of the odors. Similarly, Petitioner's evidence and argument that there are cleaning schedules when shower rooms and equipment are cleaned does not address the surveyor's observations that two shower rooms and/or pieces of equipment in those rooms were soiled with feces and that the shower rooms continued to be used. Furthermore, contrary to Petitioner's argument regarding example 2, the surveyor did testify that potentially hazardous items were in reach, even for someone in a wheelchair, and no staff was present. I conclude, based on the evidence, that the regulatory requirement to provide a "safe, clean, comfortable, and homelike environment . . . ." was violated during the period of the survey. The surveyor's testimony that the violation presented the possibility for more than minimal harm, both mentally and physically, is credible, and I so find.
This alleged deficiency was the subject of the complaint investigation which was conducted in conjunction with the annual survey. See CMS Ex. 8 and 9. There are four primary allegations against Petitioner related to R. 40: (1) staff working with R. 40 knew that R. 40 had a broken right leg but they did not know where the leg was broken; (2) although R. 40 had a doctor's order to wear bilateral knee immobilizers while up in a wheel chair, there were no orders for how to turn, reposition, or transfer R. 40 with the broken leg except a nursing treatment administration record that specified the right leg be moved as a unit, but there is no evidence this was communicated to staff; (3) R. 40 was incorrectly positioned on a mobile shower bed causing pain in her broken leg and her complaints were ignored by staff; and (4) R. 40's bilateral knee immobilizers caused bruising and abrasions, but R. 40's care plan did not address the impact of the immobilizers on R. 40's skin or require that staff check, and the immobilizers were used more often than her care plan specified. The regulatory requirement allegedly violated requires that a facility provide each resident "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." 42 C.F.R. � 483.25. This regulation requires that the facility assess the needs of each resident and develop a comprehensive plan of care to address the needs. The comprehensive plan of care is the direction or guide that the facility uses to deliver necessary services to each resident. The plan of care is also the standard to which the surveyors look to determine whether necessary services are actually delivered. Where the plan of care requires services, but the records of the facility do not show delivery, a deficiency is generally found. Further, where it is determined that a resident has a problem, issue, or need not addressed by a care plan, it is usually concluded that no assessment was done or the assessment was inadequate and/or no plan or a deficient plan was developed and there is also a deficiency. The quality of care provisions of section 483.25 impose an affirmative duty upon providers to deliver services designed to achieve the best possible outcomes to the highest practicable degree. Woodstock Care Center, DAB No. 1726, at 25 (2000). This interpretation is based upon the legislative history of the Act and regulations which reflect that the choice was made by Congress and the Secretary to focus upon the desired ends or results of care rather than to impose rigid checklists of technical means, allowing facilities to meet the requirements for individual care in a variety of ways. See Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203; 54 FR 5,316 (1989)("The purpose of the revisions is to focus on actual facility performance in meeting residents' needs in a safe and healthful environment, rather than on the capacity of facility to provide appropriate services."). Thus, the specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of R. 40, Nancy Thompson made the observations recorded in the SOD. As Petitioner concedes, Ms. Thompson corroborated the observations recorded in the SOD by her testimony. P. Br. at 10; Tr. at 71. I have no reason to doubt the veracity of Ms. Thompson or the accuracy of her recollection of the facts related to the incident she witnessed involving R. 40 on June 26, 2001 at about 8:30 a.m. Tr. at 71-76. I find Ms. Thompson's testimony totally credible. R. 40 had a broken right leg. Staff attending her on June 26, 2001, when observed by Ms. Thompson, did not know where R. 40's leg was broken and could not tell where or how to best support R. 40's leg. R. 40 suffered pain, as indicated by her complaints, which constitutes actual harm. No plan of care has been produced as evidence that shows how Petitioner assessed and planned to care for R. 40's broken right leg, and Petitioner does not argue such plan existed. Petitioner does not deny that R. 40's use of knee immobilizers exceeded the use ordered by her doctor, and Petitioner has produced no evidence of any assessment of such use or that there was ever consultation with R. 40's doctor to determine the appropriateness of the use or whether there were alternatives. It is not disputed that the knee immobilizers were used more often than ordered or that Ms. Thompson observed bruises and abrasions on R. 40's legs from the stays on the braces, but Petitioner has presented no evidence that the impact of the immobilizers upon R. 40's skin was assessed or that Petitioner had interventions to deal with such impact or treated R. 40's abrasions. The bruising and abrading of R. 40's legs is actual harm. Petitioner argues that R. 40 was a difficult patient and a chronic complainer. P. Br. at 11-12. Petitioner argues that due to congenital deformities it was difficult to identify parts of R. 40's legs, but does not go so far as to suggest that staff could not identify the foot end of her leg as opposed to the hip area. Petitioner argues that R. 40 wanted to wear her knee immobilizers in bed. Petitioner argues that transferring R. 40 from her bed to the shower bed in the manner suggested by Ms. Thompson would cause R. 40 to be suspended above the floor while beds were being moved. P. Br. at 10-13. None of these arguments actually address the deficiency cited - why proper assessment planning was not done and documented - and are not persuasive. Petitioner also cites to Ms. Feagin's statement that the transfer was done correctly. Tr. at 314. This testimony is conclusory and unpersuasive in relation to Ms. Thompson's description of the event and discussion of the manufacturer's instructions on use of the shower bed. Tr. 61-63; CMS Ex. 25, at 39. R. 40's expression of pain while placed in the shower bed backwards, resulting in her broken leg not being fully supported, is persuasive evidence of actual harm, as are the abrasions and bruises in the area of R. 40's knee immobilizer.
The quality of care regulation imposes upon the facility a general duty to provide each resident "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." 42 C.F.R. � 483.25. A specific requirement of the regulation related to pressure sores is:
42 C.F.R. � 483.25(c). The application of this regulation is well-established by decisions by various panels of the Board. Koester Pavilion, DAB No. 1750 (2000) and Cross Creek Health Care Center, DAB No. 1665 (1998) are leading decisions in this area. The Board has noted that the pressure sore regulation contains two prongs: (1) a facility must ensure a resident who enters the facility without sores does not develop sores unless the resident's clinical condition demonstrates sores are unavoidable; and (2) a resident with pressure sores must receive necessary treatment and service to promote healing, prevent infection and prevent new sores. The Board has concluded in the area of pressure sores that a facility bears a duty to "go beyond merely what seems reasonable to, instead, always furnish what is necessary to prevent new sores unless clinically unavoidable, and to treat existing ones as needed." Koester Pavilion, DAB No. 1750, at 32 (2000); see also, Meadow Wood Nursing Home, DAB No. 1841 (2002) (loose dressing contaminated with fecal matter constitutes violation); Ridge Terrace, DAB No. 1834, at 15-16 (2002) (a single observation by a surveyor of a nurse aide cleaning an open sore area with a stool-stained washcloth was sufficient to sustain a deficiency finding under this tag). In order to establish a prima facie case, CMS must show either: (1) that a resident, who entered Petitioner's facility without pressure sores, developed such sores at Petitioner's facility; or (2) a resident at Petitioner's facility had one or more pressure sores that became worse, or became infected, or the resident developed additional sores, indicating the facility did not provide treatment and services to promote healing, prevent infection and prevent new sores from developing. If CMS makes a prima facie showing, Petitioner then bears the burden of showing that the development of pressure sores or their worsening was "clinically unavoidable." CMS alleges 2 out of 16 sampled residents, R. 2 and R. 43, developed avoidable pressure sores while at Petitioner's facility. Petitioner does not specifically deny in post-hearing briefing that R. 2 and R. 43 developed new pressure sores or that such sores were clinically unavoidable. Rather, Petitioner focuses upon the accuracy of the SOD, the risk factors present with the two residents, and some of Petitioner's interventions. P. Br. 13-16. R. 43 (Example 1) was admitted to Petitioner's facility on May 9, 2000. P. Ex. 7, at 1. A care plan dated May 15, 2000 and updated through February 15, 2001, indicates that R. 43 was assessed as at risk for skin breakdown due to decreased mobility, incontinence, and pitting pedal edema. Id. at 500. Doctors notes from May 11, 2000 through January 3, 2001 do not reflect any problems with pressure ulcers (Id. at 135-143) except, on July 14, 2000, it is noted that R. 43 had a corn on her second toe, right foot, that was reported to be a scabbed over area on July 28, 2000. Id. at 257. An acute plan of care dated June 22, 2000, characterizes the area as an ulcer and notes that it resolved as of August 18, 2000. Id. at 508. Between August 18, 2000 and December 27, 2000, there are no notes or other records indicating any pressure sores. A treatment record dated December 27, 2000, indicates R. 43 had a stage II sore on her lower right back. Id. at 275. A nursing note from December 27, 2000 indicates a stage II sore on the right hip. Id. at 565. A treatment record with observations dated from December 1, 2000 through December 29, 2000 reflects that R. 43 had a "pink area" on her coccyx on December 29, 2000, just prior to her transfer to a local hospital. Id. at 277. R. 43 was transferred to a local hospital on December 30, 2000 due to being lethargic. Id. at 160-161, 182-183. The hospital discharge orders dated January 3, 2001 indicate that R. 43 had a pressure sore on her coccyx. Id. at 164, 525. A resident assessment and nurse's notes dated January 3, 2001 indicate two stage II sores right buttock, a stage I sore upper right back, and a stage II sore on the coccyx. Id. at 334. A nurse's note dated January 5, 2001 indicates that the coccyx ulcer had worsened to a stage III ulcer and the doctor had been notified. Id. at 569. A physician's telephone order dated January 5, 2001, indicates R. 43 was being treated for a Stage III ulcer, but the location was not specified. Id. at 20. A doctor's note from January 12, 2001, indicates R. 43 had developed an "upper back bed sore." Id. at 144. Similar orders from February 1 and 14, 2001 indicate R. 43 had sacral and coccyx ulcers. Id. at 23-24. A WOCN (ET) Assessment Form dated March 20, 2001, indicates R. 43's coccyx ulcer was healed. Id. at 84. A care plan for R. 43, dated January 9, 2001 and updated to July 12, 2001, reflects that R. 43 suffered from dementia, arthritis, bilateral hand contractures, edema in her lower extremities, she had to use a wheelchair for mobility and had a limited ability to make her needs known. She was assessed as at risk for skin breakdown due to decreased mobility, episodes of incontinence, hand contractures, pitting edema and a history of skin breakdown. Petitioner's short-term goal was to ensure R. 43 remained free of skin breakdown, with no stage one or greater skin breakdown, as evidenced by an area of redness lasting more than half an hour. Interventions included keeping her skin clean and dry; turning and repositioning her every two hours to prevent skin breakdown; and checking her daily for skin breakdown. (9) CMS 26, at 14-15, 17; P. Ex. 7, at 726. Nurse's notes from May 12, 2001, indicate R. 43 had a quarter sized mushy, soft, closed area below her left small toe. P. Ex. 7, at 587. An acute plan of care for R. 43 dated May 13, 2001 and updated through July 9, 2001, also records the mushy area (10) with interventions that included avoiding pressure to the area with instruction to monitor if pressure caused by shoes, apply granulex, notify doctor if no improvement. The acute plan of care indicates that by June 16, 2001, the sore had worsened, with drainage and odor. CMS Ex. 26, at 21-23. Nurse's notes from June 16, 2001 also record that the sore had worsened. P. Ex. 7, at 590. It appears that a wound care specialist did not do an assessment until June 25, 2001, when the sore was assessed as a stage III sore. P. Ex. 7, at 85-86. Nurse's notes from May 13, 2001, also reflect the development of the sore with worsening by June 16, 2001, indicated by drainage and odor and a note that the present treatment was not effective. CMS Ex. 26, at 37- 40. A nursing note from June 24, 2001, indicates that the sore below the toe was healing well. Id. at 41. The wound care nurse's notes, dated August 14, 2001, indicate that the sore on R. 43's foot had healed, but a new stage II ulcer had presented on R. 43's coccyx. P. Ex. 7, at 98. A physician's telephone order dated September 10, 2001 indicates that R. 43 had again developed an open sore on her coccyx. P. Ex. 7, at 36. A physician's telephone order dated November 26, 2001 indicates that R. 43 died. Id. at 39, see also 157. R. 2 (Example 2) had a care plan dated August 29, 2000 and updated through November 22, 2001, which indicated that she was at risk for bowel obstruction and skin breakdown, but she had a colostomy bag and Foley catheter to prevent skin breakdown. (11) P. Ex. 2, at 21. Interventions listed on the plan of care included providing good skin care daily, providing good incontinent care, monitoring for adequate nutrition and hydration, monitoring skin weekly and, as necessary, the use of moon boots, and the use of an alternating air mattress overlay. Id. A MDS, with an assessment reference date of June 8, 2001, indicates that R. 2 had an ulcer that resolved in the preceding 90 days but no active ulcers. P. Ex. 2, at 5. Care conference nurse's notes dated June 14, 2001, indicate that R. 2's skin was intact "except some comes and goes redness on the coccyx." Id. at 20. Nurse's notes from June 21 and 22, 2001, indicate that R. 2 had a crusty open area with drainage on her coccyx/buttocks area. Id. at 25. A nurse's note from June 26, 2001 lists a small open area on R. 2's right upper back in addition to the sores on the buttocks and coccyx. Id. at 26. A facsimile to R. 2's doctor on June 26, 2001 (during the survey) indicates that R. 2 has small open areas on her buttock and right upper back. Id. at 12. An order for an alternating air mattress overlay was requested and issued on June 27, 2001, indicating a diagnosis of open area on trunk and coccyx. Id. at 13-14. R. 2 had orders for a hand splint and moon boots and direction to keep pressure off her heels. Id. at 17-18. An acute plan of care, dated June 26, 2001, also reflects R. 2 had open areas on her buttocks and right upper back. An addition to the acute plan of care, dated July 11, 2001, indicates that the right upper back sore had healed but two small red areas on R. 2's coccyx were stage II but healing. Id. at 19. My review of the evidence, particularly that provided by Petitioner, indicates that R. 43 was known to be at risk on or shortly after her admission to Petitioner's facility in the spring of 2000. By the summer of 2000, she had developed what Petitioner characterizes in its records as a pressure sore on a toe. The sore on her toe resolved by August 2000, and there were no other problems indicated until December, when Petitioner reports she had an unstaged sore (a pink area) on her coccyx and a stage II sore on her lower back. Although the coccyx sore worsened while R. 43 was in the hospital, clearly it began at Petitioner's facility before her admission to the hospital. By late March 2001, R. 43's sores had resolved. But then, in May 2001, she developed another sore on the pad below her left small toe. Interestingly, although the pressure area was identified in records from May 12, 2001, there is no indication of an assessment by a wound care specialist until June 25, 2001. This sore worsened to a stage III before it got better. The record further indicates that, following the survey, R. 43 developed yet another pressure sore on her coccyx. I discern from R. 43's records that Petitioner clearly knew that R. 43 was at risk for pressure ulcers and had, in fact, implemented some interventions. The fact that the interventions and their implementation were effective is reflected in the periods when ulcers resolved. The fact that multiple ulcers resolved on multiple occasions and that there were at least brief periods when R. 43 was ulcer free, also shows that R. 43 could heal and that ulcers were avoidable for her. The fact that ulcers developed and then worsened while R. 43 was in Petitioner's facility constitutes the CMS prima facie case. The errors in the SOD noted by Petitioner justify no relief for Petitioner as Petitioner was clearly on notice of the allegations, and all the evidence needed to show the alleged deficiency is found in its own records. Further, any errors in the SOD or in the testimony of the CMS witness regarding laboratory tests and values justify no relief for Petitioner. While laboratory values may indicate an increased risk for the development of pressure sores in any given case, in this case there is no dispute that Petitioner was on notice of the risk for R. 43. If it was Petitioner's intent to rely upon laboratory test values to indicate that the pressure sores developed by R. 43 were unavoidable, then Petitioner has failed in its proof. I have no competent evidence that R. 43's laboratory values, or any of her other medical evidence, show that her pressure sores were unavoidable. Finally, the development or worsening of pressure sores is clearly actual harm. Similarly with R. 2, Petitioner was on notice and recognized the risk for skin breakdown and had implemented interventions. As of June 8, 2001, R. 2 was apparently free of pressure sores according to the MDS completed by Petitioner's staff. By June 14, 2001, she had some red spots on her coccyx. By June 21 and 22, 2001, Petitioner's nursing notes clearly indicate that R. 2 had draining open sores. By the time of the survey, R. 2 had another sore on her back. This evidence constitutes a prima facie showing of a violation. Actual harm exists in the form of the pressure sores. Petitioner, as in the case of R. 43, presented no competent evidence that the sores suffered by R. 2 were unavoidable.
At subsection 483.25(d)(1), the quality of care regulation also specifically requires that:
CMS alleges that R. 2 was discharged from the hospital on March 2, 2001 with an indwelling urinary catheter. The catheter was continued until June 26, 2001, and then discontinued during the survey when a surveyor questioned its continued use. P. Ex. 2, at 21, 26. CMS alleges that the regulatory violation occurred because Petitioner did no assessment to determine the need for continued catheter use. The surveyor recorded that staff members gave different answers for why there was continued use of a catheter. CMS 8, at 22-23. Susan Best, the surveyor who observed R. 2 and reviewed her records, testified that in her opinion there was no on-going need for the catheter and she found no recent assessment indicating a need. Tr. at 235. CMS has failed to make a prima facie case of a deficiency. I note initially that the CMS reliance on this regulatory provision is misplaced. The language of the regulation obligates a facility to avoid catheterizing a resident unless the resident's clinical condition demonstrates that it is necessary. The regulation says nothing about a facility's obligation to remove a catheter. However, a facility's failure to assess the need for continued catheter use and to discontinue an unnecessary catheter would violate the facility's general duty to provide each resident "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." 42 C.F.R. � 483.25. In this case, however, the surveyor was in error about the existence of assessments of the need for continued catheter use. Doctor's orders reflect the on-going use of an indwelling catheter to prevent skin breakdown (P. Ex. 2, at 17); care conference nurse's notes reflect the on-going use of a Foley catheter to prevent skin breakdown (Id. at 20); a care plan dated August 29, 2000 and updated February 22, 2001, May 22, 2001, and June 8, 2001, indicate the use of a Foley to prevent skin breakdown (Id. at 21). Thus, there is evidence that assessments were made and there was a decision to continue the catheter to help prevent skin breakdown. CMS has not made a prima facie showing of a violation of 42 C.F.R. � 483.25(d)(1) or any other regulatory provision by the conduct alleged.
Another specific quality of care requirement relates to accident prevention and requires that a facility ensure that "(e)ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2). The specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of section 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue is whether the quality of the supervision or the use, or lack thereof, of assistive devices at Petitioner's facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. In order to evaluate a facility's compliance with section 483.25(h), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002) and Koester Pavilion, DAB No. 1750, at 25-26 (2000). Section 483.25(h)(2) requires that a facility provide both "assistive devices" and "adequate supervision" to prevent accidents. What supervision or assistive devices are adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. In Woodstock, the Board considered whether the facility had notice of or should reasonably have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. DAB No. 1726, at 26-27. Based on the regulation and the cases in this area, CMS meets its burden to show a prima facie case if: (1) it presents evidence that an accident occurred (with or without harm to a resident); or (2) it shows the facility failed to do what it could to supervise residents or provide assistive devices to minimize risks that could lead to accidents. CMS alleges three examples of the alleged violation involving residents 10, 21, and 34. All three residents had a history of falls and had been assessed and care planned as requiring alarms or other fall prevention interventions. CMS alleges for all three that they were observed without alarms or other devices properly attached or in use. CMS Ex. 8, at 23-28. CMS alleges there is a regulatory violation because the failure to use alarms and other devices to prevent falls, when there is a known risk for falls, is a failure to provide necessary supervision and assistive devices. The evidence shows that R. 34 had a consistent history of falling from her bed and her wheelchair while attempting to stand unassisted, including 14 or more falls in approximately one year. P. Ex. 1; CMS Ex. 24, at 8-11. R. 34's care plan shows that Petitioner implemented many interventions to attempt to prevent R. 34's repeated falls, including a low bed with mats, tether alarms for bed and wheelchair, encouragement, keeping her call light in easy reach, use of a lap buddy, and wheelchair tip bars. Id. Nancy Thompson was the surveyor who made the observations related to R. 34. Ms. Thompson testified that at the time of the survey, she observed that R. 34 had a lap buddy and a tether alarm. Tr. at 79. Ms. Thompson testified that in her opinion these interventions were ineffective as, despite the use of these interventions in the past, R. 34 continued to experience falls often because she removed her tether alarm or lap buddy. Id. at 80. Further, Ms. Thompson observed R. 34 several times throughout the survey without her tether alarm even attached. Id. at 81; CMS 8, at 24-25. Ms. Thompson testified that she discussed her observations with Petitioner's nurse supervisor who then initiated use of a pressure sensitive alarm, which Ms. Thompson agreed was a suitable intervention for R. 34. Tr. at 82. The example of R. 34 touches both prongs of the quality of care requirement to provide adequate supervision and assistive devices to prevent resident accidents: (1) Petitioner needed to find an effective assistive device because R. 34 repeatedly demonstrated her ability to remove her lap buddy and tether alarm; and (2) R. 34 needed to receive adequate supervision to ensure she did not circumvent the alarms and restraints imposed by Petitioner to prevent her from falling. R. 34's repeated falls, despite the tether alarm and lap buddy and the obvious availability of a pressure sensitive alarm, when it occurred to Petitioner's nurse supervisor to use one, show that Petitioner had not tried all reasonably available assistive devices and had not supervised R. 34 closely enough. Petitioner's assertion that it had implemented measures, a point that is not disputed, and the testimony of Ms. Feagin and Ms. Vickers about general supervision of residents and the fact that R. 34 was often not cooperative (P.Br. at 19-20), do not address the issue of whether Petitioner did all it reasonably could to address the known risk that R. 34 was going to fall again. Accordingly, I conclude that the example of R. 34 represents a violation of 42 C.F.R. � 483.25(h)(2). Example 2 involved R. 10. CMS asserts that according to her records she had nine falls between May 23, 2001 and the date of the survey. There is no question that Petitioner had interventions in place to reduce the risk of falls, including a personal tether alarm. However, the gist of the CMS complaint is that during the survey R. 10 was observed at various times without her personal alarm attached, indicating that R. 10 received inadequate supervision in the use of the alarm to prevent or minimize the risk of falls. CMS Br. at 24-25; CMS Ex. 8, at 27; Tr. at 238-239. Petitioner does not address the example of R. 10, except to summarize the testimony of Susan Best, the surveyor who made the observations related to R. 10. Petitioner does not dispute the accuracy of Ms. Best's testimony regarding seeing R. 10 without her personal alarm attached (Tr. at 239) or the accuracy of her observations in that regard as reported in the SOD. CMS Ex. 8, at 26-27; see P. Br. at 18-19. I find no reason to doubt either the accuracy of Ms. Best's observations as recorded in the SOD or her testimony. Considering all the evidence, it is clear to me that, while Petitioner implemented the intervention of a personal alarm, the frequent observation of R. 10 without that alarm attached during the brief period of the survey indicates that R. 10 was not receiving the supervision necessary to ensure that the alarm was effective. I reach the same conclusion on similar facts for example 3, which relates to R. 21. Ms. Best also made the observations related to R. 21, as recorded in the SOD. CMS Ex. 8, at 27-28. It is not disputed that Petitioner had implemented interventions, including the use of a personal alarm and keeping R. 21's call light within easy reach. P. Ex. 5, at 12. Ms. Best testified that she observed R. 21 on several occasions without his personal alarm attached or with the call light out of reach. Tr. at 242. Petitioner does not dispute the accuracy of Ms. Best's observations regarding R. 21 as recorded in the SOD (CMS 8, at 28) or her testimony. Tr. at 242; see P. Br. at 18. I find Ms. Best credible. All the evidence leads me to conclude that while Petitioner had implemented interventions, R. 21 did not receive the supervision necessary to ensure the interventions of personal alarm and call light were effective in minimizing the risk of harm associated with falls. There is no dispute that there is a risk for more than minimal harm associated with any fall of a nursing home resident or that Petitioner's records reflect that each of these three residents suffered actual harm as a result of past falls.
A facility must provide each of its residents a "nourishing, palatable, well-balanced diet" that meets the residents' nutritional and special dietary needs. 42 C.F.R. � 483.35. The regulation specifically requires that each resident receive food (1) that has been prepared by "methods that help conserve nutritive value, flavor, and appearance" and (2) that is "palatable, attractive and at the proper temperature." 42 C.F.R. � 483.35(d)(1) and (2). The SOD alleges that surveyors interviewed unspecified residents who complained that hot foods were sometimes served cold. The surveyors then tested temperatures for various foods and alleged they were inadequate to maintain nutritive value, flavor, appearance and palatability. CMS Ex. 8, at 28-30. I will not accept the out-of-court statements of unidentified residents as sufficient to support a finding of deficiency. Thus, the question is whether the taking of temperatures by surveyors is an adequate basis for a finding of deficiency. I note first that the regulation is silent as to what serving temperatures are appropriate. (12) The SOM guidance to surveyors regarding F Tag 364 and food temperatures (SOM, App. P, at 144) also does not specify what temperatures are appropriate, rather it presents a question for a surveyor to answer: "Is food served at preferable temperature (hot foods are served hot and cold foods are served cold) as discerned by the resident and customary practice?" (13) Given the lack of specific guidance in either the regulation or the SOM, there is, as Petitioner notes (P. Br. at 20), an issue of how the surveyor determined that the temperatures of the foods listed in this deficiency were inadequate. Ms. Thompson made the observations regarding this deficiency as recorded in the SOD, and she testified at hearing regarding the standard she applied. Ms. Thompson stated as follows:
Tr. at 85-86. Ms. Thompson then testified that in her opinion the foods she tested were too cool or warm because they did not meet this point of service standard. Id. at 87. Ms. Thompson cited to no published source or basis for this standard and provided no testimony that would lead me to believe that Petitioner was on actual knowledge of this standard. Tr. at 85-88. Petitioner also has not admitted that it was aware of any specific standard applicable to served food temperatures. Further, Ms. Thompson offered no testimony concerning how this temperature standard related to resident preference or customary practice. I find that CMS has failed to establish a prima facie violation of 42 C.F.R. � 483.35(d). The regulation does not include any standard for the temperature of served food or a definition of proper temperature. Further, even the guidance to surveyors does not include a listing of specific temperatures but simply indicates that hot food should be hot and cold food cold considering resident preference and customary practice. The Federal Administrative Procedure Act (APA) provides that each agency of the federal government must make available to the public by publication in the Federal Register all "substantive rules of general applicability" (5 U.S.C. � 552(a)(1)(D) and that "except to the extent that a person has actual and timely notice of the terms thereof, a person may not . . . be adversely affected by, a matter required to be published in the Federal Register and not so published." 5 U.S.C. � 552(a)(1). Even if CMS takes the position that the temperature standard applied in this case constitutes an interpretive rule, CMS must show that the affected party had actual notice absent publication in the Federal Register. See Mississippi Dept. of Human Services, DAB No. 1717, at 43 (2000) ("[A] party may not be adversely affected by an interpretative rule not published in the Federal Register unless the party "has actual and timely notice of the terms thereof," citing the Administrative Procedure Act, 5 U.S. C. � 552(a)(1), and Oklahoma Dept. of Human Services, DAB No. 1043 (1989).") Thus, CMS's reliance on a specific temperature standard which it had purportedly adopted without notice to facilities and which it failed to relate to resident preference and customary practice does not constitute a prima facie showing the Petitioner was not in compliance with 42 C.F.R. � 483.35(h)(1) and (2).
"A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental and psychosocial well being of each resident." 42 C.F.R. � 483.75. It is specifically required that:
42 C.F.R. � 483.75(f). It is alleged in the SOD that on June 26, 2001, at about 9:10 a.m., the surveyor observed four staff members use a mechanical lift to transfer R. 40 from a shower bed to her regular bed in a manner so that R. 40's legs made hard contact with the vertical bar of the lift. The surveyor concluded, based on her observation of the staff and subsequent interview with two of the nurse aides involved, that they were not competent in the use of the lift. Ms. Thompson was the surveyor who made the observations recorded in the SOD and she testified consistently with the observations recorded in the SOD. Tr. at 92-94. Ms. Thompson also testified to her opinion as to how the transfer should have been done. Tr. at 95, 289-291. Petitioner called Ms. Rhonda Feagin, Petitioner's nurse aide coordinator, to testify. Ms. Feagin was not present during the transfer in question because R. 40 had asked her to leave the room. (14) Tr. at 329-331. However, Ms. Feagin was asked to describe the usual technique used for transferring R. 40 using a mechanical lift. Ms. Feagin's description was consistent with that of Ms. Thompson. Tr. at 331-343, 345-356. Petitioner does not challenge the accuracy of Ms. Thompson's observations of the transfer of R. 40 from the shower bed to her regular bed. Rather, Petitioner takes issue with Ms. Thompson's opinion that the method used was incorrect. I do not find it reasonable to believe that the transfer of a resident using a mechanical lift should involve having to swing, push, or pull a resident in such a manner that the resident's body hits or has hard contact with a part of the lift. The fact that such hard contact occurred has not been disputed or rebutted. Further, Ms. Feagin's and Ms. Thompson's description of how the lift should have been used to effect the transfer are consistent with each other but significantly differ from the way Ms. Thompson observed staff doing the transfer. Given all the evidence, I conclude that the nurse aides who were transferring R. 40 did not demonstrate competence in the use of the lift. The hard contact with part of the lift constitutes actual harm.
Petitioner specifically waived any challenge to the reasonableness of the CMP imposed in this case. Tr. at 284. I note that the State agency reduced the recommended CMP from $750 per day to $550 per day based on the financial status of Petitioner. CMS Ex. 5. The State agency recommendation for the reduced CMP was accepted by CMS. CMS Ex. 7. I have found that CMS has not made a prima facie showing of violation of 42 C.F.R. �� 483.25(d)(1) and 483.35(d)(1) and (2) and I do not address the alleged violations of 42 C.F.R. � 483.35(h)(2), each of which CMS alleged presented the potential for more than minimal harm to Petitioner's residents. However, for the violations of 42 C.F.R. �� 483.75(f) and 483.15(a), I conclude that actual harm occurred due to the infliction of pain. CMS only assessed those violations as presenting the potential for more than minimal harm without actual harm. Considering the factors specified by 42 C.F.R. � 488.438(f), which incorporates 42 C.F.R. � 488.404, I conclude that the CMP imposed is reasonable. IV. CONCLUSION For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with participation requirements for the period June 28, 2001 through July 9, 2001 and a total CMP of $6,600 is reasonable. |
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KEITH W. SICKENDICK Administrative Law Judge |
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1. The State agency concurrently conducted an annual and a complaint survey. CMS Exs. 2-4. 2. By letter dated January 30, 2003, t he transcript of proceedings was submitted to the Parties for review and objections. CMS submitted a list of errata by letter dated February 19, 2003, which will remain with the transcript. No objection to the transcript or list of errata was filed by Petitioner. 3. A SNF is a nursing facility under the federal Medicare program and a NF is a nursing facility under the state Medicaid program. The Petitioner participates in both and is referred to as a "dually participating facility." See 42 C.F.R. � 488.301. SNFs are governed by section 1819 of the Act while NFs are subject to section 1919. 4. It was not possible to read-back the earlier proceedings at the time of the motion to strike, thus it was necessary for me to await the transcript to rule. 5. The SOD incorrectly cites to 42 C.F.R. � 483.10(d)(3) which grants residents the right to participate in care and treatment decisions. The plain language of the SOD for this citation of deficiency clearly refers to personal privacy, which is guaranteed by section 483.10(e). Petitioner has not alleged prejudice due to the incorrect citation to the regulation and no prejudice is found. 6. Petitioner notes in its plan of correction that it proposes the plan of correction without admitting or denying the existence of any alleged deficiency. I do not consider Petitioner's plan of correction to be an admission that any deficiency existed. 7. The examples are set forth in separately numbered paragraphs 1, 2 and 3. Paragraph 1 discusses R. 40, but also refers to a resident meeting where eight residents complained that "direct care staff member ignored their requests, treated them as children and did not view their suggestions as valid." CMS Ex. 8, at 3. I do not treat the reported general and conclusory allegation from the eight residents as the basis for the cited deficiency as it is uncorroborated hearsay of little or no probative value and is not sufficiently precise to allow Petitioner to prepare and present a defense.
8. Similar guidance is given the state surveyors in the SOM, App. P, at 53: "'Dignity' means that in their interactions with residents, staff carries out activities that assist the resident to maintain and enhance his/her self-esteem and self-worth." 9. The care plan appears to be inconsistent on how often R. 43 was to be checked for skin breakdown. At CMS Ex. 26, at 15, it states "check skin Q.D. for break down and wetness." Q.D. generally stands for daily. Jablonski, Dictionary of Medical Acronyms & Abbreviations, 3d ed., at 322 (1998). However, at CMS Ex. 26, at 17, the intervention indicates "(m)onitor and check skin weekly and PRN for any breakdown." PRN usually stands for as required. Jablonski, at 313. 10. The SOD incorrectly indicated R. 43's right small toe. I note that Petitioner's wound care nurse repeatedly indicted in her notes that the sore was under the right small toe also. See P. Ex. 7, at 94, 96, and 98. However, this error was noted prior to the hearing. Further, there is no prejudice to Petitioner, as it was clear from its records that the left toe and not the right toe was involved. See also CMS 26, at 49. 11. A hand-written note indicates that the Foley was discontinued on June 26, 2001. Id. at 21. 12. In fact, the Secretary rejected commenters' suggestion that the regulations set forth specific temperatures but indicated that CMS intended to issue guidelines as to proper serving temperature. In the preamble, the Secretary stated:
54 Fed. Reg. at 5329. 13. The SOM cautions that food serving temperature should not be confused with proper holding temperature. 14. There were actually two transfers, the first when R. 40 was transferred from her bed to a shower bed preparatory to going to be showered and then on R. 40's return from the shower. Ms. Feagin testified that she did see the first transfer, and, in her opinion, it was done correctly. Tr. at 313-314. |
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