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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Appellate Division |
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DATE: May 10, 2004 | ||||||||||||||||||||
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Centers for Medicare & Medicaid Services
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Docket No. A-03-68
Civil Remedies CR1020 Decision No. 1921 |
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FINAL DECISION ON REVIEW OF On June 2, 2003, the Petitioner, Western Care Management Corporation, d/b/a Rehab Specialities Inn ("Rehab"), appealed a March 31, 2003 decision by Administrative Law Judge (ALJ) Alfonso J. Montano. Western Care Management Corporation, DAB CR1020 (2003) (ALJ Decision). The ALJ Decision upheld two civil money penalties (CMPs) -- one for $8,000 per day for four days of immediate jeopardy from November 3 through November 6, 1998 (totaling $24,000), and the second for $2,500 per day from November 7, 1998 to February 7, 1999 (totaling $246,000). The CMPs were imposed by the Centers for Medicare & Medicaid Services (CMS) for alleged deficiencies found during surveys of the facility in November 1998, December 1998, and January 1999. In upholding the CMPs, the ALJ determined that from November 3, 1998 through February 7, 1999, Rehab was not in substantial compliance with a number of requirements that govern its participation in the Medicare program. In this appeal, Rehab challenged the ALJ's finding that Rehab was not in substantial compliance with 42 C.F.R. § 483.13(b), which provides that a resident has a right to be free from abuse. Rehab also contended that the ALJ failed to consider adequately certain regulatory factors in determining that the amounts of the per day CMPs were reasonable. In addition, Rehab contended that the ALJ lacked adequate grounds to uphold the amount of the CMPs because he failed to make findings regarding many of the alleged deficiencies on which CMS and the state survey agency relied to impose the CMPs. We affirm and adopt, without discussion, the ALJ's findings of fact and conclusions of law that are not challenged by Rehab in this appeal. For the reasons discussed below, we also affirm the ALJ's finding that Rehab was not in substantial compliance with section 483.13(b) because that finding is supported by substantial evidence in the record and is legally correct. With respect to whether the amounts of the CMPs were reasonable, we conclude as a threshold matter that --
In light of these conclusions, we have determined to modify the ALJ Decision to include findings of fact and conclusions of law regarding the alleged deficiencies that the ALJ did not address. In particular, we discuss in detail 23 alleged deficiencies addressed by CMS at the hearing, but not by the ALJ. With respect to these alleged deficiencies, we conclude that Rehab was in substantial compliance with two of the applicable requirements at issue, but did not meet its burden to show it was in substantial compliance with the remaining requirements at issue. In addition, we find in favor of Rehab on 11 alleged deficiencies that CMS had found constituted failure to substantially comply with a requirement, but on which CMS presented no evidence (although Rehab disputed them). We then examine the reasonableness of the CMP amounts based on these new findings of fact and conclusions of law, on the ALJ findings and conclusions that we affirm, and on the evidence in the record regarding the relevant regulatory factors. We conclude that an $8,000 per day CMP for the immediate jeopardy period (November 3 through November 6, 1998) is reasonable, but that the amount of the CMP for the period of continuing noncompliance (November 7 1998 through February 7, 1999) should be reduced from $2,500 to $2,300 per day. Regulatory Background Rehab is a California skilled nursing facility that participates in the Medicare program. Medicare's participation requirements for skilled nursing and other long-term care facilities are set forth in 42 C.F.R. Part 483, Subpart B. Provisions governing the surveying of long-term care facilities and enforcement of their compliance with participation requirements are in 42 C.F.R. Part 488, Subparts E and F. Compliance with Medicare participation requirements is verified through surveys performed by state agencies under contract with CMS. The survey agency reports any "deficiencies" on a standard form called a "Statement of Deficiencies" (SOD). See 42 C.F.R. § 488.325(a); CMS State Operations Manual (SOM), Appendix (App.) P, sec. IV. A "deficiency" is a failure to a meet a participation requirement in 42 C.F.R. Part 483. 42 C.F.R. § 488.301. Deficiency findings are organized in the SOD under alpha-numeric "tags," with each tag corresponding to a regulatory requirement in Part 483 of the regulations. See SOM, App. P, sec. IV. The facts alleged under each tag number may include a number of survey findings, each of which (if upheld) might separately support a conclusion that a facility failed to meet the regulatory requirement. (For ease in tracking and counting the survey findings that were or were not addressed by CMS and the ALJ, however, we use the term "alleged deficiency" to mean the general finding in the SOD, corresponding to a particular tag number, that a specific regulatory requirement was not met, rather than the individual facts alleged as evidence of failure to comply with that requirement.) A survey agency's findings include a determination about the "seriousness" of each deficiency. See 42 C.F.R. § 488.404. The seriousness of a deficiency depends on its "scope" and "severity." See SOM, App. P, sec. V. "Severity" refers to whether a deficiency has created the "potential for harm," resulted in "actual harm," or placed residents in "immediate jeopardy"; "scope" refers to whether the deficiency is "isolated," constitutes a "pattern," or is "widespread." Id.; see also 42 C.F.R. § 488.404(b)(1). The most serious deficiencies are those that place residents in "immediate jeopardy." "Immediate jeopardy" is defined in the regulations as a situation in which a provider's noncompliance "has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. A deficiency's seriousness
is designated in the SOD by a letter (A-L) that corresponds to a matrix
reflecting different combinations of scope and severity. See SOM
§ 7400(E). For example, a level G deficiency refers to an "isolated" deficiency
that causes "actual harm" (but not immediate jeopardy) to a resident.
Id. A level D deficiency is an isolated deficiency that does not
cause actual harm but has the potential for more than minimal harm. Id.
The full matrix appears as follows:
A facility becomes subject to remedial action when it is not in "substantial compliance" with one or more participation requirements. See 42 C.F.R. § 488.400. A facility is not in substantial compliance with a participation requirement if it has a deficiency that creates at least the "potential for more than minimal harm" to one or more residents. 42 C.F.R. §§ 488.301. If a facility is found not to be in "substantial compliance," CMS may either terminate the facility's provider agreement or allow the facility the opportunity to correct the deficiencies pursuant to a plan of correction approved by CMS. See 42 C.F.R. §§ 488.402(d), 488.406, 488.406, and 488.412. In addition, to ensure that a facility brings itself into prompt compliance, CMS may, based on the seriousness of the deficiencies and other factors, impose an intermediate remedy, such as a CMP, for the days in which the facility remains in a state of noncompliance. See 42 C.F.R. §§ 488.404, 488.406, 488.408, and 488.440. ("Noncompliance" is defined in 42 C.F.R. § 488.301 of the regulations to mean "any deficiency that causes a facility to not be in substantial compliance.") A CMP in the range of $50-$3,000 per day may be imposed for deficiencies that do not place residents in immediate jeopardy but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. § 488.438(a)(ii). For deficiencies that place residents in immediate jeopardy, a CMP in the range of $3,050 to $10,000 per day may be imposed. 42 C.F.R. § 488.438(a)(i). A CMP accrues until either the facility achieves substantial compliance or its provider agreement is terminated. 42 C.F.R. § 488.454(a). CMS's choice of remedy and the factors considered by CMS in selecting the remedy are not subject to appeal, but the facility may appeal the noncompliance findings leading to the imposition of a remedy. See 42 C.F.R. §§ 488.438(e), 498.3(13). A facility may contend on appeal that the amount of the CMP is unreasonable. See 42 C.F.R. § 488.438(e)(3). In evaluating whether the amount of the CMP is reasonable, an ALJ (or the Board) may not consider factors other than those specified (or cross-referenced) in 42 C.F.R. § 488.438(f). Id. These factors include: the seriousness of the deficiencies; the facility's history of noncompliance (including repeated deficiencies), financial condition, and degree of culpability; and the relationship of any deficiency to other deficiencies resulting in noncompliance. See 42 C.F.R. §§ 488.438(f); 488.404. Case Background The following background information is drawn largely from the ALJ Decision and is undisputed.
From November 3 to November 6, 1998, the California Department of Health Services (CDHS) performed a standard survey of Rehab. As a result of this survey (the November survey), CDHS issued a SOD with alleged deficiencies under 33 tags, 25 of which were at level D or higher and which therefore were found to constitute noncompliance. CMS Ex. 2. Under tag F441, CDHS found that from November 3 through November 6, 1998, Rehab was not in substantial compliance with 42 C.F.R. § 483.65(a), which requires a facility to establish an infection control program, and that residents were in "immediate jeopardy" as a result of this noncompliance. CDHS rated the seriousness of this deficiency at level L ("widespread" immediate jeopardy). In addition, under tag F309, CHDS found a "pattern" of noncompliance with section 483.25, which requires a facility to provide residents with necessary care and services to attain or maintain their highest practicable physical, mental, and psychosocial well-being. CDHS found that the noncompliance under tag F309, as well as the noncompliance under six other tags, had resulted in actual harm to residents. In a November 24, 1998 letter, CDHS formally notified Rehab of the November survey findings. Rehab Ex. 10. The letter indicated that the most serious deficiencies were those cited under tag F441 and tag F309. Id. at 1. CDHS advised Rehab that it would recommend that CMS impose an $8,000 per day CMP for the four days of immediate jeopardy from November 3 through November 6, 1998. Id. at 2. With respect to the non-immediate jeopardy level deficiencies, CDHS advised Rehab that it would recommend a $2,500 per day CMP if Rehab did not achieve substantial compliance by December 20, 1998. Id. On December 15, 1998, CMS issued the first of two penalty notices. Rehab Ex. 12. The December 15 notice advised Rehab that CMS was imposing a CMP of $8,000 per day based on the November survey's immediate jeopardy finding. Id. The December 15 notice reminded Rehab that despite its abatement of the immediate jeopardy, the facility continued to be in noncompliance (as evidenced by the November survey findings) and that additional remedial action would be taken if the facility failed to attain substantial compliance with all participation requirements. Id. at 2. Following the November survey, Rehab submitted a plan of correction which represented that Rehab had achieved substantial compliance with all participation requirements. See CMS Ex. 2. On December 22, 1998, CDHS performed a revisit survey of the facility, alleging 16 deficiencies and finding that Rehab continued to be in noncompliance with 13 participation requirements. See Rehab Ex. 14; CMS Ex. 85. Rehab was again cited under tag F309 for a pattern of noncompliance with section 483.25. CDHS also found other areas of noncompliance, previously identified during the November survey, that had not been corrected. On January 14, 1999, CDHS resurveyed Rehab for the purpose of investigating an incident of possible abuse reported by Rehab. See CMS Ex. 142; Tr. at 695, 717. As a result of the January survey, Rehab was cited by CDHS for nine alleged deficiencies, eight which were at level D or higher. CMS Ex. 142. The SOD for the January survey included findings, under tag F223, concerning three incidents in which Rehab allegedly failed to safeguard residents from verbal, physical, or mental abuse. Id. at 6-9. On January 21, 1999, CMS issued a second penalty notice. CMS Ex. 140. The January 21 notice advised Rehab that it was not in substantial compliance with Medicare participation requirements and that CMS was imposing two remedies based on the December survey findings: a CMP of $2,500 per day effective November 7, 1998; and a denial of payment for new admissions (DPNA) effective February 5, 1999. (1) Id. CDHS surveyed Rehab again in February 1999. Based on the February 1999 survey, CMS determined that Rehab had attained substantial compliance as of February 8, 1999. See Rehab Ex. 26. Rehab filed timely requests for hearing challenging all of the findings of all three surveys. Rehab Exs. 19, 25, 27.
During the October 2000 hearing in this case, CMS presented 187 exhibits and the testimony of eight witnesses, including three nurse surveyors (Pamela Valencia, Carol Mattern, and Henry Martin); a CDHS physician consultant (Dr. Robert Watson); a pharmaceutical consultant (Lori DeMartini, Pharm. D.); and an infection control specialist (Christine Cahill). CMS's evidence addressed many (but not all) of the alleged deficiencies in the SODs for the three surveys. The following is a list of the alleged deficiencies (by tag number and level of seriousness) from the SODs. The underlined tag numbers represent alleged deficiencies about which CMS presented no evidence:
Paula Perse, a CMS health insurance specialist, testified about the factors considered by CMS in setting the amount of the CMPs. Tr. at 895-904. One of these factors was Rehab's noncompliance history. Ms. Perse testified that Rehab had a "significant history of complaints" and had been designated by the State of California as a "focused enforcement facility" because of its poor compliance history. Tr. at 896, 898-899. Jeffrey McVicker, an auditor employed by one of Medicare's fiscal intermediaries, testified about Rehab's financial condition. Mr. McVicker, who holds a bachelor's degree in accounting, testified that Rehab had sufficient assets that could be used to pay the CMPs without jeopardizing the health or safety of residents. Tr. at 839-866. Rehab submitted 69 exhibits but called no witnesses to rebut the testimony and other evidence submitted by CMS. In its post-hearing brief, Rehab contended that the amount of the CMPs was unreasonable. Rehab PHB at 68-77. It asserted that its placement in the CDHS "focused enforcement program" was unwarranted because the relevant documents showed that it "had a good history of compliance with the law." Id. at 70-71. Rehab also contended that CMS failed to consider its financial condition when assessing the penalties, and that its financial statements showed it to be incapable of paying the large CMPs that had been imposed. Id. at 72-74. In addition, Rehab asserted that "[t]here is no culpability, repeat deficiencies or any disregard for the residents, by Rehab or its staff," and that the "scope and severity" of the deficiencies was "unsupported" and "inappropriately placed at a high level." Id. at 74-77.
The ALJ determined that Rehab was not in substantial compliance with Medicare participation requirements from November 3, 1998 through February 7, 1999. In support of this determination, the ALJ found Rehab to be in noncompliance with the following participation requirements (see ALJ Decision at 7-31):
With respect to tag F441 (November survey), the ALJ found that Rehab's noncompliance with section 483.65(a)(1) had placed residents in immediate jeopardy from November 3 through November 6, 1998. ALJ Decision at 14-17. In addition, with respect to tag F223 (January survey), the ALJ determined, in three numbered findings, that Rehab had failed to ensure that Resident 12 was free from abuse by facility staff, that Resident 14 was free from abuse by facility staff, and that Residents 5 and Resident 10 were free from abuse by Resident 11. Id. at 24-28. The ALJ also found that any one of these three findings was sufficient to establish that Rehab was not in substantial compliance with section 483.13(b). Id. at 28. Finally, the ALJ determined that the amounts of the CMPs imposed by CMS were reasonable. ALJ Decision at 31-32. In support of this determination, the ALJ stated:
Id. at 31. In addition, the ALJ rejected Rehab's contention that it lacked the financial ability to pay the CMPs and accepted as credible Mr. McVicker's testimony that Rehab could pay the them without being forced to close the facility or compromise patient care. Id. at 31-32. Standard of Review Our standard of review on a disputed conclusion of law is whether the ALJ decision is erroneous. Our standard of review on a disputed issue of fact is whether the ALJ decision as to that fact is supported by substantial evidence on the record as a whole. See Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/ guidelines/); South Valley Health Care Center, DAB No. 1691 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000). Discussion In its request for review, Rehab challenged only one of the ALJ's findings on noncompliance -- namely, the finding under tag F223 that the facility had failed to ensure that Residents 5 and 10 were free from abuse by Resident 11. Request for Review (RR) at 26. In section A below, we explain why we reject Rehab's contentions, and thus affirm the ALJ's finding that Rehab was not in substantial compliance with section 483.13(b). (As indicated above, we affirm and adopt, without discussion, all of the ALJ's noncompliance findings that Rehab did not challenge.) Rehab also contended, on two main grounds, that the ALJ erred in finding that the amounts of the CMPs were reasonable. First, Rehab contended that the ALJ failed to consider or adequately consider the relevant regulatory factors in deciding that the CMPs were reasonable. RR at 24-26. Second, Rehab contended that the $2,500 per day CMP for the non-immediate jeopardy level deficiencies may not be sustained because the ALJ failed to make findings regarding a substantial majority of the alleged deficiencies. Id. at 19-20, 26. We conclude, in section B, that the ALJ did not make adequate findings regarding the regulatory factors and that the ALJ should have considered the impact of his decision not to address certain deficiencies on his determination that the amounts of the CMPs were reasonable. For these reasons, we make new findings, in section D, regarding the reasonableness of the CMPs. In addition, for reasons explained below, we modify the ALJ Decision to include findings regarding the alleged deficiencies not addressed by the ALJ. These findings appear in section C. Based on the uncontested findings made by the ALJ, and on our new findings in sections C and D, we conclude that the amount of the CMP imposed by CMS for the immediate jeopardy period was reasonable, but that the amount of the CMP for the remaining period of noncompliance should be reduced from $2,500 to $2,300 per day.
Section 483.10 of the regulations states that a long term care facility "must protect and promote the rights of each resident." 42 C.F.R. § 483.10. Section 483.13(b) states that a resident "has the right to be free from verbal, sexual, physical and mental abuse[.]" 42 C.F.R. § 483.13(b). The term "abuse" is defined in section 488.301, for purposes of 42 C.F.R. Part 488, as "the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish" (italics added). Because Part 488 is related to Part 483 and because "abuse" is not separately defined for purposes of Part 483, the Board has upheld, as reasonable, an ALJ's application of this definition in a case involving alleged noncompliance with section 483.13(b). Beverly Health and Rehabilitation Center -- Williamsburg, DAB No. 1748 (2000). As indicated above, the ALJ made findings concerning three sets of factual allegations on which CMS relied for its finding of noncompliance with section 483.13(b), and Rehab appealed only the findings regarding the third set of allegations, which involved Residents 5, 10, and 11. The following facts were undisputed: Resident 11 was a 78-year old female with Alzheimer's disease and depression. On December 22, 1998, a nurse reported that Resident 11 had wandered into Resident 5's room and pushed her down. On January 2, 1999, a nurse reported that Resident 11 had been found in Resident 10's room, hitting and kicking Resident 10, who was screaming and holding up her hands for protection. Based largely on these facts, on facts derived from Resident 11's medical records (which we set out below), on the testimony of Dr. Watson, and on his other findings under this tag, the ALJ concluded that Rehab "did not ensure the residents' right to be free from abuse . . . ." ALJ Decision at 28. Rehab contended that the ALJ's conclusion was erroneous because the allegations related solely to "resident-to-resident interaction" and because Resident 11 was incapable of perpetrating "abuse" due to her inability to engage in "willful" behavior. RR at 27-28. We reject these contentions and conclude that a finding that a non-resident has committed an act of abuse is not a prerequisite for finding a deficiency under section 483.13(b). Under the regulations, a resident has the "right to be free from" abuse, and a facility must "protect and promote" that right. 42 C.F.R. §§ 483.10 and 483.13(b). This obligation is stated more broadly than the requirements of subsection 483.13(c), which focuses on staff treatment of residents. Protecting and promoting a resident's right to be free from abuse necessarily obligates the facility to take reasonable steps to prevent abusive acts, regardless of their source. Hitting, kicking, or pushing down another person is conduct that would ordinarily be considered abuse because it involves the direct infliction of force, is likely to cause physical harm, pain, or mental anguish, and ordinarily involves a perpetrator who intends to injure the victim. See SOM, Appendix PP, Guidelines for tag F223 (noting that "physical abuse" includes "hitting, slapping, pinching and kicking"). There is substantial evidence in the record to support the ALJ's determination that Rehab did not protect and promote residents' rights to be free from abuse. Nursing notes and other records document several instances of Resident 11 striking or attempting to strike other residents between November and mid-December 1998. CMS Ex. 151, at 6, 8, 12-13. On at least two occasions during this period, Resident 11 hit or pushed down another resident after wandering into the resident's room. Id. at 6, 8, 12. Nurses reported that she had to be "redirected constantly." Id. at 11. On December 22, 1998, the interdisciplinary team noted that she was becoming "more hostile." Id. at 14. It is apparent that Rehab regarded this pattern of conduct as physically abusive because the comprehensive assessments (dated September 18 and December 18, 1998) identified it as such. Id. at 3. Consequently, prior to the incidents on December 22 and January 2, Rehab knew or should have known of a substantial risk that Resident 11 might inflict injury on another resident. In view of that risk, Rehab had a duty to take reasonable steps to mitigate the risk of harm to other residents. Rehab asserted that it took reasonable steps to prevent Resident 11 from harming other residents, in part because it provided "one-to-one" monitoring of Resident 11. RR at 28. However, Rehab did not explain or show what "one-to-one" monitoring entailed, and the nursing notes are unclear about how such monitoring was actually carried out. On December 23, 1998, the duty nurse instructed her staff to perform "continuous monitoring" (emphasis added) of Resident 11's whereabouts and to "redirect her" when she was near other residents or wandering into their rooms. CMS Ex. 151, at 12. A follow-up note, also written on December 23, indicates that Resident 11 had been started on "[every] 15 min[ute] monitoring & prn [as needed] for any striking out at others or wandering near other residents or in other rooms." Id. The two notes are inconsistent in some respects: the first appears to require uninterrupted monitoring; the second indicates that at times the staff would perform only intermittent (every 15 minutes) monitoring. Rehab proffered no testimony or other evidence to explain this apparent inconsistency, to explain how intermittent monitoring could be effective if Resident 11 required "constant" redirection, or to describe what monitoring was actually done. Nor did Rehab explain how Resident 11 managed to evade the nursing staff responsible for monitoring her behavior and to enter Resident 10's room on January 2, 1999. Rehab also pointed to the fact that it spoke to social services and family members about placing Resident 11 in another facility. RR at 28. However, Rehab's attempts to arrange for Resident 11's transfer did not begin in earnest until after the incident involving Resident 10. See CMS Ex. 151 at 9-10. Moreover, any effort to transfer Resident 11 did not diminish the facility's obligation to protect other residents as long as she remained in the facility. Rehab's contention that Resident 11 lacked the mental capacity to perpetrate abuse is unavailing here, for several reasons. First, it is clear that the nursing staff regarded her behavior as abusive and understood the need to take reasonable steps to mitigate the attendant risk of harm to other residents. Thus, Rehab can hardly contend that its failure to protect the other residents from Resident 11 was because it did not believe her capable of abuse. Second, Rehab did not specify how we should construe the term "willful" or demonstrate that Resident 11's cognitive deficits rendered her unable to perform a willful act under a proper construction of that term. (2) The term "willful" has multiple meanings in the law -- from "malicious" to "not accidental" -- depending on the context in which it is used. See McLaughlin v. Richland Shoe Co., 486 U.S. 128, 137 (1988)(Marshall, J., dissenting). While it is reasonable to read the term "abuse" in section 483.13(b) as having the same meaning as it has for purposes of Part 488, it does not follow that a facility has no duty under section 483.13(b) to act to prevent harm to other residents from a resident with a known propensity to engage in potentially injurious behaviors such as hitting or kicking others, merely because the resident has cognitive deficits. The goal of section 483.13(b) is to keep residents free from abuse. This goal cannot be achieved if a facility could be found in compliance even though it failed to take reasonable steps to protect residents from potentially injurious acts which it knew or should have known might occur and which might be willful, in any sense of that word. (3) Our holding in this case is consistent with our decisions addressing section 483.25(h)(2), which requires a facility to provide residents with adequate supervision and assistance devices to prevent "accidents." To show noncompliance with section 483.25(h)(2), CMS need not show that an "accident" occurred, only that the facility failed to take reasonable steps to protect a resident from foreseeable risks of harm. See Windsor Park Care Center, DAB No. 1902 (2003); Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd Woodstock Care Ctr. v. Thompson, No. 01-3889 (6th Cir. 2003). Similarly, CMS does not need to establish that "abuse" occurred in order to show that the facility failed to protect and promote a resident's right to be free from abuse. Cf. 59 Fed. Reg. 56,116, 56,130 (Nov. 10, 1994)(rejecting suggestion that a facility may be cited for "neglect" only when a resident is actually harmed, and noting that the "potential for negative outcomes" should be considered). Rehab suggested that the ALJ's finding of noncompliance is inconsistent with our holding in Beverly, which also involved an allegation of resident-to-resident abuse. Reply Brief at 22. We find no inconsistency, however. In Beverly, there was no evidence that the resident who had caused the harm had engaged in a pattern of behavior that the facility identified as abusive. Beverly involved a cognitively-impaired resident who unplugged another resident's respirator one time. When asked why she had done this, the resident stated that the respirator's noise was bothering her and she wanted it to stop. The Board determined that there was substantial evidence for the ALJ's finding that this incident did not involve "abuse" because there was no evidence that the resident who unplugged the respirator was aware of the connection between the respirator and the resident to whom it was connected. CMS sought to infer abuse solely from the mental anguish suffered by the resident whose respirator was unplugged, but any such inference, the Board found, was dispelled by the perpetrator's statement of what her intent was. In contrast, one could reasonably infer that Resident 11 intended her hitting, kicking, and pushing to inflict injury, because such injury is the normal and expected direct consequence of those acts. (4) Accordingly, we affirm the ALJ's determination that Rehab was not in substantial compliance with section 483.13(b).
Rehab contended that the ALJ's findings were erroneous or inadequate in a number of respects. RR at 2-26. Much of Rehab's argument in support of this general contention was devoted to showing that CMS acted arbitrarily and without sufficient justification in setting the CMPs near the top of the applicable penalty ranges ($8,000 per day for the four days of immediate jeopardy in November 1998, and $2,500 per day for the period from November 7, 1998 to February 8, 1999). For example, Rehab asserted that CMS failed to consider Rehab's financial condition and erroneously determined that its record of compliance (prior to the November 1998 survey) was poor. Id. at 4-9, 12-13. Rehab asserted that its record of compliance prior to 1998 was actually good and that CDHS had erroneously placed it in the state's "focused enforcement" program. Id. at 8-9. In addition to criticizing CMS for alleged flaws in its internal decision-making process, Rehab contended that the ALJ did not consider its "history of compliance" in evaluating the reasonableness of the CMPs but merely "deferred" to testimony given by Paula Perse (the CMS health insurance specialist) concerning its compliance history. RR at 4, 24-25. Rehab also contended that the scope and severity of the deficiencies did not justify the severe CMPs imposed. Id. at 19-26. We disagree with Rehab that CMS's alleged failure to consider certain factors in initially setting the amounts of the CMP is a valid basis for relief. The Board has consistently held that an ALJ is not required to make any finding concerning the procedures CMS used in selecting a remedy or setting the amount of a CMP. (5) Emerald Oaks, DAB No. 1800 (2001). In general, the ALJ hearing is a "de novo proceeding to be resolved on the evidence in the record developed before the ALJ, and is not a quasi-appellate review of the correctness of HCFA's determination based on the evidence HCFA had at the time it acted." Vitas Healthcare Corp. of California, DAB No. 1782, at 4 (2001). Accordingly, the ALJ (or other fact-finder) must make an independent determination about "whether the evidence presented on the record concerning the relevant regulatory factors [in 42 C.F.R. § 488.438(f)] supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved[.]" CarePlex of Silver Spring, DAB No. 1683, at 8 (1999). In short, it is the ALJ's -- not CMS's -- decision-making that concerns us. We thus turn to Rehab's contentions regarding the adequacy of the ALJ's findings. An ALJ's assessment of whether the amount of the CMP is reasonable must be guided by the factors specified in (or cross-referenced by) 42 C.F.R. § 488.438(f). These factors are the facility's history of noncompliance, its financial condition, its degree of culpability for the cited deficiencies, the scope and severity of those deficiencies, and the relationship between or among the deficiencies. CarePlex. Most of these factors were at issue here. The ALJ Decision relies on a conclusory analysis that fails to address the evidence presented by Rehab on the relevant factors and fails to explain adequately the basis for his conclusion that the substantial amounts imposed here were reasonable, even though he had made far fewer noncompliance findings than CMS. Other than noting that Paula Perse gave credible testimony about CMS's reasons for imposing the CMP, the ALJ did not discuss or evaluate the evidence concerning Rehab's history. The ALJ is correct that the designation of Rehab by CDHS as a "focused enforcement facility" is not a reviewable "initial determination" under 42 C.F.R. Part 498. The issue, however, is whether that designation was in fact reliable evidence of a history of noncompliance. "Noncompliance" means "any deficiency that causes a facility to not be in substantial compliance" and a "deficiency" is a failure to a meet a participation requirement in 42 C.F.R. Part 483. 42 C.F.R. § 488.301. Rehab asserted that it was erroneously placed in the focused enforcement program (and therefore erroneously considered a "poor performer by CMS) because CDHS had based the designation on State-only requirements and on low level deficiencies, and CMS did not directly dispute this assertion. As discussed below, the documents show some history of noncompliance, but not to the degree that Ms. Perse's testimony (on which the ALJ relied) would suggest, and therefore it appears likely that the ALJ gave this factor undue weight. In addition, Rehab contended that the CMPs should not be sustained because the ALJ "did not uphold or issue a finding supporting the substantial majority" of the alleged deficiencies. See RR at 19. Rehab argued:
Id. at 20. Rehab pointed out that the testimony of Ms. Perse indicated that the first thing CMS looked at was the seriousness of the deficiencies. Id., citing Tr. at 895. The ALJ Decision contains no discussion at all concerning the scope and severity of the deficiencies or their relationship. We agree with Rehab that that omission is especially significant because the ALJ addressed only 11 of the 34 alleged deficiencies on which CMS presented testimony (listed by tag number on pages 7-8 above), failed to address some findings at a high level of noncompliance such as a pattern of actual harm, and failed to address other alleged deficiencies on which CMS presented no testimony. Since Ms. Perse's testimony about CMS's reasons for choosing the CMP amounts related to a substantially different set of findings than those made by the ALJ, he could not reasonably rely on that testimony, however credible, to support any conclusion about the seriousness of the deficiencies. Citing Beechwood Sanitarium, DAB No. 1824 (2002), the ALJ stated that he was "not mandated to address each and every deficiency cited" because the statute and regulations require a facility to meet all participation requirements and because a single instance of noncompliance is sufficient to warrant the imposition of a CMP. ALJ Decision at 6-7 (citing section 1819(d)(4)(A) of the Social Security Act and 42 C.F.R. § 488.430(a)). Accordingly, he stated that, as an "exercise of judicial discretion," he would discuss "only those deficiencies argued during the course of the hearing as they pertain to all three surveys." Id. To the extent the ALJ was suggesting that it is wholly a matter of judicial discretion whether to address all or only some of the CMS findings of noncompliance, the ALJ's reliance on Beechwood is misplaced. While that decision stands for the proposition that an ALJ has discretion, as an exercise of judicial economy, in determining whether to address findings that are not material to the outcome of a case, that decision clearly contemplated that an ALJ would address and resolve any material dispute. As the Board pointed out in Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), in cases involving a CMP imposed on a per day basis, there are three potential issues to be addressed by an ALJ: (1) Was there a basis for imposing any CMP (that is, did the provider in fact fail to comply substantially with program requirements)? (2) What was the duration of the period of noncompliance? (3) Was the amount of the CMP reasonable? The ALJ here correctly concluded that he did not need to address all of the CMS findings in order to resolve the first issue -- whether a basis existed to impose a remedy. Moreover, the noncompliance findings the ALJ made were sufficient to establish the duration of the period of noncompliance, and Rehab did not challenge his decision on that issue. Rehab had, however, contended that the amounts of the CMPs were out of proportion to the seriousness of the alleged deficiencies. The survey agency had indicated that it considered the findings under tag F309 as among the most serious and had pointed out that Rehab was cited under this tag in all three surveys. Yet, the ALJ Decision did not address the tag F309 findings, nor did it address the findings under many other tags to which CMS had assigned a relatively high level of noncompliance (including levels G, E, and F) or cited in more than one survey. In light of these omissions and the size of the penalties, Rehab's contention that the penalties were not justified by the seriousness of its noncompliance required the ALJ to consider carefully whether the deficiencies he addressed were sufficient to support the CMPs imposed, and whether findings favorable to Rehab on the unaddressed deficiencies would have been material to his determination that the amounts of the CMPs were reasonable. The ALJ Decision does not reflect such consideration. The only rationale suggested for the ALJ's choice of deficiencies to discuss was whether CMS had presented testimony on them at the hearing, yet the ALJ Decision did not in fact address all of the deficiencies on which CMS witnesses testified. In any event, this rationale is not sufficient. The potential materiality of unresolved deficiency findings may depend, of course, on whether there are adequate grounds to sustain the amount of a CMP in view of the deficiencies actually addressed. In evaluating reasonableness, the ALJ may, depending on the quality of the evidence and the nature of the deficiencies, attach more significance to certain deficiencies than others, or assign more weight to certain regulatory factors than to others. The ALJ is not obligated to weigh the factors as CMS did and may, if circumstances warrant, find a CMP to be reasonable based on fewer deficiencies than those addressed at the hearing or contained in the SOD. See Batavia, DAB No. 1904, at 24, 59-64. On the other hand, the ALJ may not reasonably rely solely on testimony about the reasons CMS set a CMP at a certain level without examining whether those reasons are consistent with the ALJ's findings and the documentary record. We recognize that CMS's enforcement experience places it in a good position to know whether a CMP of a given size will be effective in advancing the goal of encouraging prompt and consistent compliance with Medicare participation requirements. Where, as here, CMS's reasons include factors such as the seriousness, number, and relationship of the deficiencies, however, the ALJ may not fairly disregard or ignore underlying factual disputes related to those factors without a persuasive reason. In sum, to ensure that there is no prejudice to either party and to facilitate appellate review, the ALJ must clearly identify the factors on which he relied in evaluating whether the amount of the CMP was reasonable, explain why the evidence concerning these factors was sufficient to justify the CMP imposed by CMS (or as modified by the ALJ), and, if he does not address all of the CMS noncompliance findings, explain why he considers the unaddressed findings to be immaterial to any of the issues he must resolve. The ALJ did not do that here. After considering the record as a whole regarding all of the relevant factors, we conclude that the ALJ's finding regarding the reasonableness of the $2,500 per day CMP for the non-immediate jeopardy level deficiencies was not supported by substantial evidence in the record. We further conclude that the ALJ erred in treating the unaddressed deficiencies as immaterial on the issue of the reasonableness of the amounts of the CMPs and that this error was prejudicial to Rehab. Given the number, seriousness, and relationships of the unaddressed deficiencies, we conclude that a reasonable fact-finder could not have maintained the CMPs at the levels imposed by CMS had findings in favor of Rehab been made on all or a significant number of the remaining contested deficiencies. When the Board reviews an ALJ decision and finds a prejudicial error, the Board may either issue a dispositive decision or remand the case to the ALJ. 42 C.F.R. § 498.88(a). While ordinarily we would remand a case if further factual findings are required, the record here is fully developed, and Rehab did not request a remand. CMS on the other hand argued that a remand was unnecessary, that there was a need for closure in the matter, and that the Board could "most effectively" resolve any additional issues. CMS Response Brief at 45. Moreover, Rehab did not specifically challenge the ALJ's findings on witness credibility (to which we would in any event defer) or present any witnesses of its own. We also note that this case took an extraordinary amount of time for the hearing to be scheduled and for the issuance of the ALJ Decision, as well as for our review, in light of the number and nature of the deficiencies at issue. Thus, any procedural loss to the parties from not having an initial ALJ decision on the additional issues, subject to Board review, is minimal and is outweighed by the benefits of bringing this matter to closure. Accordingly, we have modified the ALJ Decision to include findings (in section C) on alleged deficiencies not addressed by the ALJ as well as findings (in section D) on the factors relevant to determining whether the amounts of the CMPs were reasonable.
In making additional findings, we apply well-established burden of proof rules. CMS must come forward with sufficient evidence on disputed facts that together with the undisputed facts will establish a prima facie case that the facility is not complying with one or more participation requirements. The facility may rebut a prima facie case of noncompliance by showing, by a preponderance of the evidence, that it is in substantial compliance with participation requirements. Once CMS has established a prima facie case, the provider may then offer evidence in rebuttal, both by attacking the factual underpinnings on which CMS relied and by offering evidence in support of its own affirmative arguments. An effective rebuttal of CMS's prima facie case would mean that at the close of the evidence the provider had shown that the facts on which its case depended (that is, for which it had the burden of proof) were supported by a preponderance of the evidence. See Ross Healthcare Center, DAB No. 1896 (2003); Batavia, DAB No. 1904; cf., Hillman Rehabilitation Center, DAB Nos. 1611 (1997), and 1663 (1998); aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999). We discuss each alleged deficiency for which CMS presented evidence, indicating the survey, the tag number, and the level of noncompliance found by CMS. We then address the alleged deficiencies for which CMS presented no evidence.
Section 483.10(b)(3) states that a resident "has the right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition" (emphasis added). "Total health status" includes information about medical care received in the facility. See SOM, App. PP (tag 154 guidelines). The SOD states that Rehab violated section 483.10(b)(3) because it did not obtain from Resident 10 her timely informed consent to the administration of two drugs -- Buspar, an anti-anxiety drug, and Risperdal, an anti-psychotic drug. CMS Ex. 142 at 1-2. Resident 10, who was 89 years old, was admitted to Rehab on October 3, 1998. Tr. at 684. Her October 14, 1998 comprehensive assessment indicates that she was independent in decision-making. Tr. at 685. Physician orders do not indicate that she was incapable of participating in her plan of care. Tr. at 686; CMS Ex. 150, at 13. Surveyor Valencia testified that she observed Resident 10 conversing with the nursing staff and that she appeared to be "very on-track and in-tune mentally." Tr. at 685. On October 15, 1998, a physician signed an order to put Resident 10 on Buspar and Risperdal. Tr. at 686; CMS Ex. 150, at 5. The nursing staff informed Surveyor Valencia that Resident 10's informed consent to these drugs should have been noted in the nursing notes or physician orders. Tr. at 686-687. Surveyor Valencia found no notation of informed consent in the nursing notes from this period. Tr. at 687. The physician orders show that Rehab did not obtain informed consent until October 28, 1998, 12 days after Resident 10 started taking the two drugs. Tr. at 686-687; CMS Ex. 150, at 5, 8-9. Surveyor Valencia testified that she found no evidence in her review of Rehab's records that Resident 10 gave informed consent prior to October 28, 1998, and no evidence that Resident 10 lacked the necessary mental or legal capacity to receive information about her medical care. Tr. at 686-687. Surveyor Valencia also testified that Rehab's failure to obtain informed consent created the potential for more than minimal harm because the drugs had potentially severe side effects that Resident 10 might have chosen to avoid. Tr. at 689. Rehab offered no evidence that it obtained Resident 10's informed consent to the drugs prior to October 28. Instead, it suggested that the harm was no more than minimal because Resident 10 actually suffered no adverse effects from the drugs. For purposes of determining whether Rehab was in substantial compliance, however, it is immaterial whether she in fact suffered actual harm (i.e., the side effects). It was undisputed that the drugs had the potential to cause severe side effects and thus the potential to cause more than minimal harm. In short, CMS proffered facts and evidence showing that Rehab gave Resident 10 Risperdal and Buspar for 12 days before obtaining her informed consent to receive those drugs, and therefore failed to keep her fully informed of her total health status. CMS also furnished evidence that this failure to obtain Resident 10's informed consent created the potential for more than minimal harm. Rehab did not rebut any of CMS's evidence, and offered no evidence or argument establishing that it was in substantial compliance. Accordingly, we find that Rehab was not in substantial compliance with section 483.10(b)(3) during the January survey.
Section 483.10(b)(11)(i)(B) states that a facility "must immediately inform the resident; consult with the resident's physician; and if known, notify the resident's legal representative or an interested family member when there is . . . [a] significant change in the resident's physical, mental, or psychological status (i.e., a deterioration in health, mental, or psychological status in either life-threatening conditions or clinical complications)" (emphasis added). The SOD describes four alleged instances of noncompliance with this requirement. CMS Ex. 142, at 3-6. We discuss only the ones for which CMS presented testimony and argument.
Resident 3 was 91 years old. Her plan of care indicated that she had fragile and easily torn skin. Tr. at 670, 677. She was totally dependent on the nursing staff for her needs. Tr. at 672. A review of Resident 3's medical records revealed 16 documented instances of skin tears or other skin-related problems between September 1 and December 31, 1998, including the following five problems: (1) a skin tear on the left outer calf (September 11); (2) a skin tear on the right forearm (September 28); (3) a skin tear on the right calf (October 10); (4) a skin tear on the left wrist (November 23); and (5) a large bruise under the right armpit (December 7). See Tr. at 670-71, 675-76. During the survey, Surveyor Valencia found no evidence that any of these five problems had been reported to the physician. Tr. at 678. She testified that the problems were clinical complications (i.e., "significant changes") because, on two other recent occasions, Resident 3 had developed cellulitis, a skin infection that is serious in elderly persons, and required treatment with antibiotics. Tr. at 674-677. Surveyor Valencia also testified that Rehab's failure to report the problems to the physician created the potential for bacterial infections at the other sites where her skin was bruised or torn. Tr. at 678-679. Rehab contended that the five skin tears specified above were not "significant changes" in Resident 3's condition, and therefore its failure to notify the physician of these changes did not constitute a violation of section 483.10(b)(11)(i)(B). However, it offered no evidence to rebut Surveyor Valencia's opinion that the changes were significant given Resident 3's apparent susceptibility to skin infections. In addition, Rehab's assertion that the changes were not significant is unsupported by any argument based on the applicable regulatory language. Section 483.10(b)(11)(i)(B) states that a significant change is a "deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications" (emphasis added). Examples of "clinical complications" include a stage II pressure sore, recurrent urinary tract infections, or the onset of depression. See 56 Fed. Reg. 48826, 48833 (Sept. 26, 1991); SOM, Appendix PP (tag 157 guidelines). Rehab did not rebut Surveyor Valencia's testimony that the five unreported skin problems were clinical complications. Nor did it submit evidence to rebut her testimony that the failure to report the problems created a potential for more than minimal harm from repeated bacterial skin infections. Tr. at 679. Rehab suggested that the five skin tears not reported to the physician were not significant changes because Resident 3's physician was aware of her fragile skin and had ordered treatment for the 11 other skin tears. Rehab PHB at 58. On cross-examination, Surveyor Valencia confirmed that Rehab had assessed those 11 skin tears when they occurred and had treated them pursuant to physician orders. Tr. at 704, 711-712. Contrary to what Rehab suggested, however, the physician's treatment orders were not general or standing orders intended to cover any skin tear suffered by the resident. The only treatment orders in the record are for skin tears at specific locations, and, as indicated, there are no orders applying to the five skin tears for which physician notification was lacking. See CMS Ex. 147, at 37-47. The fact that the physician ordered particularized treatment upon learning of various skin tears supports CMS's contention they were significant changes requiring physician notification. Rehab provided no basis to distinguish the tears of which the physician was notified from those for which no notice was given. Based on the evidence submitted by CMS, we find that on five occasions between September 1 and December 31, 1998, Rehab failed to notify Resident 3's physician of significant changes in Resident 3's condition, and that these omissions created the potential for more than minimal harm to Resident 3. Accordingly, we find that Rehab was not in substantial compliance with section 483.10(b)(11)(i)(B) in its care of Resident 3.
Resident 1 (who was not the Resident 1 mentioned in prior surveys) was 89 years-old, needed help with transfers, and had fractured her left hip in the past. Tr. at 680, 682. A review of nursing notes and other records revealed that Resident 1 fell in her room on December 14, 1998 and sustained a bruise the size of a baseball on her left buttock. Tr. at 680-682; CMS Ex. 148, at 1, 3. Surveyor Valencia testified that the bruise constituted a significant change in Resident 1's condition because she was prone to hip fractures. Tr. at 682-683. Surveyor Valencia also testified that she had found nothing in the facility's records to indicate that the physician had been notified of the bruise. Id. In addition, Surveyor Valencia testified that this omission created the potential for more than minimal harm. She noted that the bruise might have become larger and developed complications, especially because Resident 1 was on Coumadin, a blood thinner that increased the risk of bleeding and additional tissue damage. Tr. at 684. The foregoing facts and evidence establish that Rehab failed to notify the physician of a significant change in Resident 3's condition, and that the omission created the potential for more than minimal harm. Rehab offered no evidence to rebut CMS's prima facie showing of noncompliance but instead asserted that CMS had failed to establish the potential for more than minimal harm. In particular, Rehab asserted that the potential for harm Surveyor Valencia identified was merely that the bruise could have become larger. Rehab PHB at 59 (citing Tr. at 721). However, Surveyor Valencia's primary concern was that the resident was prone to, and might have sustained, a hip fracture as a result of the fall. Rehab acknowledged that it was likely that the bruise was caused by a fall but ignored Surveyor Valencia's concern about a hip fracture. Rehab also ignored Surveyor Valencia's testimony about the potential complications associated with the bruise (bleeding and tissue damage). We have considered Rehab's various other contentions regarding this deficiency and find them to be without merit. Accordingly, we conclude that Rehab was not in substantial compliance with section 483.10(b)(11)(i)(B) in its care of Resident 1.
Section 483.15(b)(3) states that a resident has the right to "[m]ake choices about aspects of his or her life in the facility that are significant to the resident." The SOM states that this requirement is meant to ensure that a facility "provides an environment that is respectful of the right of each resident to exercise his or her autonomy regarding what the resident considers to be important facets of his or her life." SOM, App. PP (tag 242 guidelines). This deficiency concerns Resident 1, who was the subject of other deficiency findings addressed by the ALJ. One of those other findings was that Rehab had violated section 483.13(c)(2) because its nursing staff had failed to report unexplained bruises on Resident 1's arms. See ALJ Decision at 12-13. Surveyor Valencia testified that she interviewed Resident 1, who told her that the bruises had been caused by the nursing staff forcing her to go to bed when she did not want to. Tr. at 52. Notations in the record indicate that Resident 1's daughter had advised the nursing staff in July 1998 that her mother should be allowed to stay up as long as she wanted. Tr. at 54; CMS Ex. 185, at 77. Surveyor Valencia testified that Resident 1 suffered actual harm as a result of the staff's conduct, including bruising on her arms and the indignity of being put back to bed against her will. Tr. at 67. Dr. Watson testified that the bruises had "hues of discoloration" indicating that they had been caused by multiple or repeated incidents. Tr. at 363-64. Based on the foregoing evidence, it is a reasonable inference that Resident 1 was not given the right to make choices about aspects of her life that were significant to her -- namely, the right to stay up late if she wanted to. Contrary to what Rehab argued, CMS's failure to present information regarding specific dates on which Resident 1 was put to bed against her will was not fatal to its case. All that was required was credible evidence that Resident 1 had recently been put to bed against her will. Resident 1's statement to the surveyor that she had been forced to go to bed and that her arm bruises had been caused by the nursing staff during these incidents is credible evidence that this in fact occurred. Rehab presented no evidence that would cause us to question the reliability of the surveyor's report of Resident 1's statements or the reasonableness of the inference drawn from CMS's evidence as a whole. Accordingly, we conclude that Rehab was not in substantial compliance with section 483.15(b)(3) in its care of Resident 1.
Section 483.15(h)(1) requires the facility to provide a "safe, clean, comfortable, and homelike environment[.]" The SOD states that this requirement was not met because two resident halls and a resident room had strong urine odors. CMS Ex. 142, at 9-10. Surveyor Valencia testified that, on January 12, 1999, she noticed that the Trinity Alps hall in the facility smelled like urine. Tr. at 690. On January 13, she noticed that the Trinity Alps and Shelter Cove halls had strong, foul urine odors. Id. On January 13, Surveyor Valencia interviewed Resident 1 in her room and noticed that the room smelled like urine. Id. Resident 1 stated to Surveyor Valencia that her room smelled this way because her roommate was incontinent. Id. Resident 1 also stated: "My friends don't like to visit my room because it always stinks." CMS Ex. 142, at 10. Rehab suggested that no violation had occurred because "urine is smelled at times in skilled nursing facilities." Rehab PHB at 62. It is, of course, unreasonable to assume that a nursing home will always be free of unpleasant odors. However, according to Surveyor Valencia, the odors detected by her were strong or "stale" in places, detectable on two consecutive days, and present in two or three areas of the facility (the two wings, and Resident 1's room). Surveyor Valencia testified that, in her opinion, the presence of urine odors, which are "not common in our houses," constituted a failure by Rehab to maintain a clean and homelike living environment for Resident 1 and the other residents of the Trinity Alps and Shelter Cove halls. She also testified that there was a potential for more than minimal harm because visitors would come to Resident 1's room less frequently because of the urine odor. Tr. at 692. Rehab offered no evidence to rebut Surveyor Valencia's opinions or their factual underpinnings. Rehab instead pointed out that Surveyor Valencia had indicated on cross-examination that she had no proof that Resident 1 received fewer visits in her room because of the odor and no proof that the urine odor had existed for an extended period of time. Rehab PHB at 62 (citing Tr. at 727, 741). This ignores, however, the statements by Resident 1 that her "friends don't like to visit my room because it always stinks." Rehab did not deny that Resident 1 had made this statement to the surveyor or challenge its reliability. Based on the evidence just described, we find that Rehab failed to provide Resident 1 and other residents with a clean and homelike environment and that this deficiency created the potential for more than minimal harm. Accordingly, we conclude that Rehab was not in substantial compliance with section 483.15(h)(1).
Under data tag F283, the SODs for the November and December 1998 surveys refer to alleged violations of 42 C.F.R. § 483.20(e). See CMS Ex. 2, at 22 and Ex. 85, at 8. The citations in the SODs to section 483.20(e) were erroneous because, effective March 23, 1998, section 483.20(e) had been re-designated as section 483.20(l) without substantive change. See 62 Fed. Reg. 67,211 (December 23, 1997). However, because the re-designation involved no substantive change to the regulation, the survey agency's erroneous citation of section 483.20(e) did not violate Rehab's rights. Section 483.20(l) requires a facility to prepare a "discharge summary" that includes a "recapitulation of the resident's stay" and a "final summary of the resident's status to include items in paragraph (b)(2) of this section, at the time of the discharge that is available for release to authorized persons and agencies, with the consent of the resident or legal representative[.]" (Emphasis added.) The cross-reference to the "items in paragraph (b)(2)" is a drafting error: the cross-reference should be to the items in paragraph (b)(1) of section 483.20. Paragraph (b)(1) specifies items that must be included in a resident assessment instrument. They include the resident's customary routine, cognitive pattern, physical functioning, continence, disease diagnoses and health conditions, skin condition, medications, and special treatments and procedures. 42 C.F.R. § 483.20(b)(1). The intent of section 483.20(l) is to ensure that residents receive appropriate discharge planning and that necessary medical and other information is transmitted to post-discharge caregivers. See SOM, App. PP (tag F283 guidelines).
On August 18, 1998, Resident 25 was discharged from Rehab to a board and care facility with diagnoses of chronic back pain and a compression fracture. Tr. at 198. Based on a review of facility records, Surveyor Mattern determined that the discharge summary did not include information about the following: (1) Resident 25's allergy to sulfa drugs and her allergy to iodine when used as a contrast dye for x-rays; (2) the date of her last bowel movement (she had a history of constipation); (3) her history of urinary incontinency and urinary tract infections; (4) her recent skin tear and the treatment given for that tear; and (5) the date and time she last received pain medication (which she had taken regularly until August 5, 1998, after which her prescription was changed to indicate that she could continue to take it on an "as needed" basis). See Tr. at 198-199. Surveyor Mattern testified that, in her opinion, Resident 25's final discharge summary was not complete because it did not include information about her medical condition, medical history, special treatments and procedures, and drug therapy. Tr. at 200-201. She also testified that Rehab's failure to include information about hose items created the potential for more than minimal harm. Tr. at 201. Rehab contended that "[t]he regulation does not state what information should be included" in the discharge summary. Rehab PHB at 21. However, the regulation cited by the survey agency, section 483.20(e) (re-designated as section 483.20(l)), clearly specified the required contents -- namely, a "recapitulation of the resident's stay" and information about the items listed in section 483.20(b)(1). Rehab also contended that there was no violation because Resident 25 was discharged to a "board-and-care" facility, where she, and not another caregiver, was responsible for her own needs. Rehab PHB at 21-22. However, this fact is irrelevant because the purpose of the discharge summary is to inform any future caregiver (including the resident) about the resident's status to ensure that her medical needs are dealt with in a timely and appropriate fashion. Rehab also asserted that there was no potential for anything more than minimal harm. Rehab PHB at 22. However, it made no argument to support this assertion, and it failed to rebut Surveyor Mattern's testimony to the contrary. Finally, Rehab asserted that the SOD failed to contain "notice . . . of any alleged thirteen points, or other provisions, that are allegedly required to be in this summary." Rehab PHB at 22. However, the items required to be in the summary are specified in the regulation, of which the facility had constructive notice. Accordingly, we conclude that Rehab was not in substantial compliance with section 483.20, as found during the November survey.
Resident 14 was discharged from Rehab on December 8, 1998. Tr. at 607. She had a diagnosis of chronic obstructive pulmonary disease and had been recently treated for pneumonia. Id. Two bronchodilators (or inhalers) had been prescribed for her -- Albuterol and Atrovent. Tr. at 607. Her final discharge summary contained instructions about how these two inhalers were to be administered at home: for Albuterol, two puffs four times per day; for Atrovent, two puffs twice per day. Tr. at 607; CMS Ex. 119, at 5. Surveyor Mattern testified that the dose-and-frequency instructions on Rehab's discharge summary did not match instructions given by the respiratory therapist on a document entitled "Respiratory Care Weekly Summary/Discharge Summary." Tr. at 607-608. The respiratory therapist's instructions for the inhalers were four puffs of Albuterol (no frequency was specified) and four puffs three times per day of Atrovent. Tr. at 608. Surveyor Mattern testified that Rehab's nurse could not produce any current physician orders for the inhalers. Tr. at 608-609. In addition, she testified that inhalers need to be administered only in accordance with a physician order that specifies dose and frequency. Tr. at 608. She testified that a patient who receives too much inhaler is at risk for heart palpitations, and that a patient who receives an insufficient dose may have difficulty breathing. Id. Surveyor Mattern's testimony regarding Resident 14 is sufficient to establish that Rehab's final summary regarding her status failed to contain accurate information regarding her drug therapy, as required by section 483.20(l), and that this omission created the potential for more than minimal harm. Rehab suggested that the regulations required only that the final summary contain information about Resident 14's drug therapy (which the summary did), not that the information be accurate or correct. See Rehab PHB at 45. However, section 483.20(l) implicitly requires that the medical information contained in the final summary be accurate and complete. A failure to include complete and accurate information would undercut the very purpose of the final summary, which is to ensure appropriate discharge planning and future care. Rehab contended that Surveyor Mattern never contacted the physician to verify his orders for the bronchodilators. Rehab PHB at 45. However, the surveyor was not required to obtain that information under these circumstances. The physician orders should have been in the facility's treatment records, and it is undisputed that they were not. Rehab also asserted that there was no potential for anything more than minimal harm. Rehab PHB at 45. However, it offered no evidence to rebut Surveyor Mattern's testimony concerning the potential for harm from using excessive or inadequate doses of the inhalers. Finally, Rehab contended that the testimony regarding the discrepancy between the dose-and-frequency instructions in the facility's discharge summary and the instructions in the respiratory therapist's summary was "irrelevant" and "unduly prejudicial" because the SOD alleges no such discrepancy. Rehab PHB at 45. This contention has no merit. The SOD states that a licensed nurse had been interviewed about the directions given to Resident 14 and that the nurse had received instructions from the respiratory therapist about how the inhalers were to be administered at home. CMS Ex. 85, at 9. In addition, the SOD states: "There were no physician orders for the inhalers to be administered as directed in the discharge summaries." Id. (emphasis added). These findings clearly notified Rehab that CMS intended to rely on the respiratory therapist's instructions (which could reasonably be considered evidence of what the physician had ordered) and that, to rebut the deficiency finding, Rehab needed to produce physician orders consistent with the discharge summary. Thus, Rehab should have known from the SOD that the respiratory therapist's instructions, and the degree to which they were consistent with the final summary, were at issue. Accordingly, we conclude that Rehab continued to be out of substantial compliance with section 483.20(l), as found at the December survey.
Surveyors use data tag F309 to identify noncompliance with the general quality of care requirement in 483.25, which provides:
This standard, based on section 1819(b)(2) of the Social Security Act (Act), is part of the statutory scheme under which a facility is required to do periodic comprehensive assessments of each resident and to develop written plans of care to meet the resident's needs as identified in the comprehensive assessment. See also section 1919(b)(2) of the Act; 42 C.F.R. § 483.20. Rehab's arguments with respect to several residents (discussed more specifically below) suggest that the phrase "in accordance with the comprehensive assessment and plan of care" acts as a limit, so that if a service is not one specified in the plan of care, a facility may not be cited under this section for failure to provide that service. This Board has rejected similar arguments in the past, for several reasons. See, e.g., Alden-Princeton Rehabilitation & Health Care Center, DAB No. 1873, at 6-9 (2003)(Alden). First, the language refers not only to the plan of care but also to the comprehensive assessment. If a facility has identified a need in the assessment, it may not reasonably excuse its failure to take steps to meet the identified need based on its own failure to include in the plan of care specifically what services it will provide to meet that need. See 42 C.F.R. § 483.20(k)(1)(a plan of care must include "measurable objectives and timetables to meet a resident's needs and must describe the services to be furnished to attain or maintain the resident's highest practicable well-being"). Second, the quality of care requirement at section 483.25 is not just that the facility provide services in accordance with the comprehensive assessment and plan of care, but that the facility ensure that each resident receives care and services necessary to attain or maintain his or her "highest practicable well-being." As the Board noted in Alden, some of the specific provisions of section 483.25 "involve facility responsibilities that do not depend on any individual resident's assessment or care plan, such as providing a resident environment as free of accident hazards as possible and ensuring a medication error rate below five per cent. 42 C.F.R. § 483.25(h)(1) and (m)(1)." Id. at 6-7. Thus, the section as a whole may not reasonably be read as requiring only those services specifically included in a comprehensive assessment and/or plan of care. Focusing on the goal of ensuring that the resident receives care and services to attain or maintain the "highest practicable" well-being leads to other conclusions relevant to evaluating compliance with section 483.25, as well. First, if a physician has ordered a service or a specialist has recommended a service, it is reasonable to infer, absent convincing evidence to the contrary, that the order or recommendation reflects a resident need that must be met in order to achieve the goal. Thus, failure to act on the order or recommendation evidences a failure to comply with the requirement. Second, this Board has upheld an ALJ's conclusion that section 483.25 implicitly requires that a facility adhere to professionally recognized standards of care in providing care and services to its residents. See Lake City Extended Care Center, DAB No. 1658, at 5 (1998). Care and services not meeting the standards would not ensure that the goal is met. Finally, the service needed to meet the quality of care goal may be, at times, to evaluate why a negative outcome develops or persists. Without such an evaluation, a facility cannot ensure that any needed care or services are provided. As explained below, CMS established that Rehab did not provide certain residents with the necessary care and services to attain or maintain their highest practicable well-being, that Rehab's failures in this area created at least the potential for more than minimal harm, and that Rehab's noncompliance with section 483.25 spanned all three surveys.
The SOD for the November survey contains six findings of alleged noncompliance under tag F309. See CMS Ex. 2, at 23-28. CMS proffered testimony regarding four of those findings. We address those four findings here, and explain why we conclude that Rehab was not in substantial compliance with section 483.25 at the time of the November survey.
Resident 1 had a suprapubic cathether, which was inserted through the abdomen. Tr. at 68-69. The physician had ordered the catheter to be irrigated twice every Tuesday and changed once every six weeks. Tr. at 69; CMS Ex. 183, at 37-40, 45; CMS Ex. 14, at 5. Surveyor Valencia testified that Resident 1's treatment records revealed that her catheter had not been irrigated as ordered. These records in fact indicate that on August 4, August 11, August 25, September 1, September 22, September 29, October 13, and October 20 (all Tuesdays), the catheter was flushed only once rather than twice as ordered. Tr. at 69-70; CMS Ex. 183, at 37-40. Surveyor Valencia testified that the catheter was scheduled to be changed on October 10, 1998 but that nothing in Resident 1's treatment records indicated that it was changed during October 1998. Tr. at 70; CMS Ex. 179, at 2. In addition, Surveyor Valencia testified that Rehab had no nursing policies or procedures on how to change a suprapubic catheter; that the policy shown to her during the survey was for the insertion of a Foley catheter, which is inserted through the urethra (not the abdomen) using a procedure different from the one used to insert the suprapubic catheter; and that conversations with Rehab's education nurse and the nurse who last changed Resident 1's catheter revealed that the nursing staff had not been trained on procedures for inserting a suprapubic catheter. Tr. at 70-71. Based on these facts and observations, Surveyor Valencia stated that it was her professional opinion that Rehab had failed to provide Resident 1 with the necessary care and treatment in order for her to attain or maintain her highest practical physical well-being. Tr. at 71-72. Finally, Surveyor Valencia testified that Resident 1 had suffered actual harm from this deficiency because she had had chronic urinary tract infections within the previous six months, as documented in the plan of care. See Tr. at 72-73; CMS Ex. 183, at 6, 7, 44. Rehab contended that the physician had ordered the catheter to be flushed and changed "as needed" ("PRN"), rather than at specified frequencies. Rehab PHB at 22. However, the evidence Rehab cited, a daily treatment log, does not support this assertion because it is undated and because it makes no reference to changing a catheter. In contrast, CMS's evidence includes dated treatment logs and physician orders that support its contention that the catheter was to be changed at specified intervals. See CMS Ex. 183, at 37, 45; CMS Ex. 95, at 16. Rehab suggested that CMS should have questioned the nurses to determine whether the catheter had, in fact, been irrigated twice each Tuesday as ordered. Rehab PHB, at 23. We find no merit to this contention because Rehab offered no reason why CMS could not rely on Resident 1's treatment records, which indicate that the catheter was not irrigated at the prescribed frequency. Rehab did not deny that Resident 1 had had urinary tract infections within the six months prior to the November survey. Instead, Rehab contended that CMS failed to establish that she had suffered actual harm because CMS presented no evidence that she had had a urinary tract infection during November 1998. Rehab PHB at 23. However, nothing in the regulations or statute precluded CMS from characterizing the scope and severity of the deficiency based on actual harm suffered prior to the survey. Cf. Regency Gardens Nursing Center, DAB No. 1858 (2002)(a deficiency may be evidenced by events that occurred prior to the actual survey dates). Rehab also complained that the SOD failed to mention that Resident 1 had had urinary tract infections. Rehab PHB at 23. However, the SOD's purpose is not to provide a comprehensive recitation of the evidence supporting the survey agency's findings. Its purpose is to notify the facility of the nature, scope, and severity of the deficiencies found and the factual basis for the survey agency's conclusion that regulatory standards had been violated. See Pacific Regency Arvin, DAB No. 1823 (2002). The SOD was adequate in this regard. Although it did not mention that Resident 1 had had urinary tract infections, it informed Rehab that the alleged deficiency had resulted in actual harm, a finding based on Rehab's own records. Given that the alleged deficiency involved a failure to irrigate a urinary catheter, the facility could have reasonably expected that CMS might offer evidence about Resident 1's history of urinary tract infections. Information about these infections was within Rehab's control. Under the circumstances, we find no prejudice to Rehab's due process rights. We have considered Rehab's other contentions regarding this deficiency finding but find them to be without merit.
Resident 22 was an 81 year old female who wore a TKS (total knee support) brace and needed assistance with ambulation. Tr. at 74. To address her impaired mobility, her plan of care called for physical therapy, an eight-week functional maintenance program conducted by an RNA (restorative nursing assistant), and use of the TKS brace. Id. Surveyor Valencia testified that her inspection on November 4, 1998 revealed that Resident 22 did not ambulate that day but instead moved about by propelling herself in a wheelchair. Id. Surveyor Valencia also testified that her interviews with the nursing staff revealed that Resident 22 had not ambulated for the previous two weeks (prior to that she had ambulated every day); that she could not walk anymore because the TKS brace hurt and no longer fit; and that she was no longer receiving ambulation services from the RNA. Tr. at 75. Surveyor Valencia testified that because Rehab failed to provide Resident 22 with a properly fitting TKS brace, she could not ambulate and thus was unable to maintain her highest practicable physical well-being. Tr. at 75-76. Surveyor Valencia also noted that staying in a wheelchair results in muscle atrophy, which can occur quickly (within two days) in a person of Resident 22's age. Tr. at 76. Finally, Surveyor Valencia testified that Resident 22 suffered actual harm because her physical functioning or mobility had declined as a result of being unable to ambulate. Id. Rehab contended that Resident 22 "received the appropriate treatment and services." Rehab PHB at 24. In particular, Rehab pointed to a November 6, 1998 progress note purportedly written by Resident 22's physical therapist. Rehab Ex. 44, at 2. The progress note states in relevant part:
Id. Based on this progress note, Rehab contended that Resident 22 had received all the necessary treatment and services and that she was able to ambulate but had simply refused to do so. We give little weight to the November 6 progress note because it was written two days after Nurse Valencia's inspection. The implication that Rehab wants us to draw from this document -- that Resident 22 had refused to ambulate despite a properly fitting brace -- was not corroborated by medical records from around the time of the survey (i.e., October and early November 1998). For these reasons, we find inadequate grounds to discount Surveyor Valencia's testimony (based on interviews with Resident 22 and the nursing staff) that Resident 22 had not received a properly fitting TKS brace and other services necessary to maintain her ability to ambulate.
Resident 11 was a 67 year old male with multiple pressure sores on his tail bone. Tr. at 76-77. On March 16, 1998, his physician ordered that certain laboratory tests -- complete blood count (CBC) and albumin -- be performed each month because of the pressure sores. See CMS Ex. 19, at 3. The ordered tests were listed as an intervention in Resident 11's plan of care. Id. at 5, 8. Surveyor Valencia testified that albumin is a blood protein and that its level is monitored to track a patient's nutritional status and to determine how well pressure sores are healing and the treatment needed to promote healing. Tr. at 77. Surveyor Valencia testified that she found no records indicating that the CBC and albumin tests were performed during July and September 1998. Tr. at 77; CMS Ex. 19, at 5. She also testified that Rehab's failure to perform the albumin test as ordered created the potential for more than minimal harm because the test results might have revealed a need for additional measures to promote healing of his pressure sores or to improve his nutritional status. Tr. at 78-78. Rehab did not deny that it failed to perform the ordered lab tests during July and September. Instead, it suggested that there was no potential for anything more than minimal harm because the available test results -- for June, August, and October 1998 -- showed that his albumin levels were stable. However, these test results do not establish that there was no potential for more than minimal harm. An evident purpose of the periodic laboratory tests was to monitor Resident 11 for clinical changes -- in particular, a reduction in the level of albumin in his blood -- to ensure that any necessary treatment or other intervention was timely and appropriate. If his albumin level had dropped significantly during, say, early July or early September, the change would have remained undetected for several days or weeks, delaying the initiation of appropriate treatment and possibly prolonging the healing process.
Resident 12 was admitted to Rehab on September 18, 1998. Tr. at 160. On September 23, 1998, he had blood drawn for various laboratory tests, including a Chem panel, a CBC, and Protime. Id. On October 2, 1998, his blood was drawn again for Protime and INR tests, which provide information about the blood's ability to clot. Tr. at 160-161. Surveyor Mattern testified that her review of Resident 12's medical records revealed no physician orders for the blood draws on September 23 and October 2. Tr. at 162. She also testified that Rehab violated section 483.25 by subjecting Resident 12 to unnecessary blood draws, and these created the potential for more than minimal harm because there is a risk of infection every time the skin is broken with a needle to extract blood. Tr. at 162. Surveyor Mattern also noted that Resident 12 was on Coumadin, a blood thinner, and that inserting a needle to take blood could have resulted in unnecessary or excessive bleeding. Id. Rehab did not deny that there were no physician orders for the tests but suggested that the tests, conducted shortly after Resident 12's admission to the facility, were necessary to "obtain a complete blood count and the blood clotting factor for this resident." Rehab PHB at 25. However, the evidence Rehab cited to support this assertion does not, by itself, establish that he needed all of these tests. While it might be reasonable to infer from the evidence that, since he was on a blood thinner, the tests for blood clotting would be useful to ensure the dosage was correct, Rehab did not explain why it did not obtain, or did not need to obtain, a physician's order for each of the tests. Rehab suggested that CMS failed to make a prima facie showing of noncompliance because Resident 12 suffered no unnecessary bleeding, infection, or skin irritation, and that "[t]he benefits from these tests far outweighed any remote potential for harm." Rehab PHB at 25-26. We find little merit in these contentions. Whether Resident 12 suffered actual harm is immaterial because CMS needed to show only that the circumstances created a potential for more than minimal harm. In addition, Rehab offered no evidence to support its assertion that the benefits of the unnecessary tests outweighed their risks, and no evidence to rebut Surveyor Mattern's testimony that the unnecessary tests had the potential for more than minimal harm.
Like the SOD for the November survey, the SOD for the December survey contained multiple findings under tag F309. CMS proffered evidence regarding five of those findings. We address those findings here and explain why we conclude that Rehab continued to be out of substantial compliance with section 483.25 at the time of the December survey.
Resident 10 was an 88-year old woman with diagnoses of chronic obstructive pulmonary disease and congestive heart failure. Tr. at 584. During November 1998, she was put on antibiotics for five days for right lower lobe pneumonia. Id. On December 8, 1998, her physician ordered an x-ray, which was performed the following day, to determine if or to what extent the pneumonia had cleared. Id. The results of the x-ray are contained in a December 9, 1998 report, which states in relevant part:
CMS Ex. 117, at 16. A handwritten note on the report indicates that it was faxed to the physician on December 9, 1998 (and re-faxed on December 14). Rehab Ex. 62, at 3. There is no evidence that the physician contacted Rehab to confirm his receipt of the report on December 9 or to provide instructions to the nursing staff. On December 12, 1998 at 10:00 p.m., a nursing assistant noted that Resident 10 had been confused and lethargic all shift. CMS Ex. 117, at 10. On December 13, 1998, at 6:00 p.m. and 9:00 p.m., a nursing assistant reported that Resident 10 was confused, asked the same question repeatedly, was weak when standing, and had "mottled" legs. Id. These observations were reported to the licensed nurses in charge of managing Resident 10's care, but the nursing progress notes for December 12 and 13 do not mention these changes. See id. at 19-20; Tr. at 585-586. On December 14, 1998, Rehab notified the physician that Resident 10's condition was worsening. Tr. at 586; CMS Ex. 117, at 6. On that day her temperature was 100.6 degrees, and she was put on Rocephin, an antibiotic. Tr. at 586, 588-589; CMS Ex. 117, at 22. Surveyor Mattern testified that in light of the findings in the December 9 chest x-ray report that Resident 10's lung pattern was worse than it was during November, Rehab should have confirmed that the physician had received the report and requested instructions:
Tr. at 588. Surveyor Mattern also noted that the nursing staff should have performed (but did not perform) a respiratory assessment after receiving the x-ray report. Tr. at 586. In addition, she faulted Rehab for not contacting Resident 10's physician for more than 24 hours after the nursing assistant first reported symptoms of deterioration (lethargy and confusion) on December 12. See Tr. at 586-587. Finally, Surveyor Mattern testified that as a result of these lapses, Resident 10 suffered actual harm because her physical condition declined between December 9 and December 14 (in particular, she became confused and weak and started to run a temperature). Tr. at 589. The foregoing evidence establishes that Rehab failed to elicit a response from the physician concerning the December 9, 1998 x-ray report that indicated a worsening of Resident 10's pulmonary condition, failed to perform a respiratory assessment upon learning of the x-ray results, and, one week later, waited more than 24 hours to notify the physician of symptoms of deterioration reported by the nursing staff (but not documented in the nursing progress notes). Rehab made a variety of assertions in response to the evidence submitted by CMS, but none has merit or significance. For example, Rehab asserted that, in addition to faxing the x-ray report on December 9, a nurse left a recorded message for the physician on December 9. Rehab PHB at 47. However, the nursing notes indicate that this message was left for the resident's daughter, not for the physician. Rehab Ex. 62, at 13. Rehab asserted that its nursing staff contacted the physician by fax on December 10, and that the physician responded by placing new treatment orders. Rehab PHB at 47. However, the December 10 fax and new treatment orders related to Resident 10's pain medication, not to the findings of the December 9 x-ray report. See CMS Ex. 117, at 20. Rehab also suggested that Surveyor Mattern should have contacted Resident 10's physician to determine whether the physician was, in fact, aware of her condition. Rehab PHB at 47. However, Rehab did not explain why it was necessary for the surveyors to have done this. The surveyors obtained, and CMS presented, prima facie evidence of noncompliance -- namely, credible evidence that Rehab did not meet nursing standards because it had made no reasonable attempt to elicit treatment instructions from the physician after it had faxed an x-ray report showing deterioration in Resident 10's pulmonary condition, and because it had waited more than 24 hours to contact the physician after the resident began to show signs of confusion and weakness. The burden was therefore on Rehab to show that its action or inaction was reasonable and consistent with accepted nursing standards. To the extent that testimony from the physician would have helped Rehab carry its evidentiary burden, it was Rehab's obligation to obtain a statement or testimony from the physician or from any Rehab employee who talked with the physician. Rehab asserted that Resident 10 did not have a temperature between December 9 and December 13 (see Rehab PHB at 47), but treatment logs do not show that vital signs were actually taken during that period (see Rehab Ex. 62, at 19). In any event, even if Resident 10's temperature was under control, Rehab did not explain why this would excuse its failure to take timely steps to address her worsening lung condition (mentioned in the December 9 x-ray report) and the symptoms subsequently reported by the nursing assistant.
Finding 2 under tag F309 concerns Resident 2, a 54-year old man who was designated as Resident 12 during the November survey. Tr. at 590. During the November survey, he complained of being uncomfortable in his wheelchair. Id. On November 16, 1998, he underwent a wheelchair evaluation by a physical therapist. Id. A medical supplier was also consulted on that day. Id. Based on these evaluations, a determination was made that Resident 2 needed a hemi wheelchair, which is designed for persons who cannot propel an ordinary wheelchair due to stroke or paralysis. Id. On December 16, 1998, Surveyor Mattern spoke with a Rehab nurse and the medical equipment supplier. Tr. at 591. She learned from these conversations that the hemi wheelchair had not been ordered, and that a signed physician order had not yet been sent to the supplier. Id. The supplier informed Surveyor Mattern that it would take three and one-half to four weeks from the day the physician order was received to obtain payment authorization for the wheelchair. Tr. at 591-592. Surveyor Mattern testified that this delay resulted in actual harm to Resident 2 because it was uncomfortable for him to be up in a regular wheelchair, which in turn caused him to stay in his room more often and be more socially isolated. Tr. at 592-594. The foregoing facts and evidence show that on December 16, 1998, one month after a physical therapist had recommended that Resident 2 have a hemi wheelchair based on an evaluation of his needs, Rehab had not taken steps to obtain the hemi wheelchair. There is no evidence or allegation that Rehab considered and reasonably rejected the therapist's recommendation, or that it had a medical reason for the delay. For this reason, we find that Rehab did not provide Resident 12 with the necessary care and services to attain his highest practicable well being. Rehab asserted that no violation had occurred in part because there was no physician's order for a new wheelchair. Rehab PHB at 48. However, Rehab did not demonstrate that such an order was required under the circumstances. Treatment records show that, on November 9, 1998, the physician ordered both a physical therapy evaluation and "TX [treatment] if indicated" by the evaluation. This order for prospective treatment suggests that Resident 12 was to receive care contingent on the outcome of the therapist's evaluation, not on the subsequent evaluation or orders of the physician. Even assuming, however, that a physician's order was, in fact, necessary before the hemi wheelchair could be obtained, Rehab did not submit any evidence that it had sought a physician's order or that the physician had actually rejected the recommendation. Thus, we conclude that the mere absence of a physician's order for the wheelchair did not excuse Rehab's complete failure to take any prompt action upon the therapist's recommendation. Rehab contended that it provided all the care and services required by Resident 2, suggesting that he did not, in fact, need a hemi wheelchair. Id. at 47-48. In particular, Rehab alleged the following: on November 11, 1998, the physical therapist placed dycem on the seat of Resident 2's existing wheelchair to prevent him from sliding in it. On November 16, 1998, the therapist evaluated Resident 2 again for seat sliding. On November 18, 1998, a safety repair was performed on the wheelchair. On November 18, 1998, the therapist documented that Resident 2 had been seen five times since the November 16 wheelchair evaluation and that he was no longer sliding in the seat. On November 23, 1998, the wheelchair was checked again for fit, alignment, and safety. See id. Although these facts indicate that Rehab took steps to repair his existing wheelchair and to mitigate the problem of his sliding in the chair, they do not establish that Resident 2 did not need the hemi wheelchair, which the physical therapist had recommended, to maintain his highest practicable level of functioning. In addition, Surveyor Mattern noted that the repairs were just a temporary measure and were not equivalent to giving him the hemi wheelchair. Tr. at 652-653. Rehab contended that the surveyor's testimony that Resident 2 suffered actual harm because of being isolated and uncomfortable is "completely unsupported." Rehab PHB at 48. However, Surveyor Mattern testified that Resident 2 had complained of being uncomfortable in the wheelchair during the November survey. Tr. at 590; see also CMS Ex. 2, at 29. Even if Rehab's temporary adjustments to the existing wheelchair addressed the comfort problem, Rehab's evidence did not establish that the steps it took would improve his wheelchair mobility in a manner comparable to providing him with the hemi wheelchair, and thus the evidence is not adequate to rebut CMS's case that there was actual harm.
Surveyor Mattern testified that she observed Resident 4 with long, thick toenails that curled and pressed into the flesh of the toes next to them (especially on the right foot). Tr. at 594-595; see also CMS Ex. 87, at 3-4 (photographs). Resident 4's medical records included a November 3, 1997 physician's order for podiatric care as needed. CMS Ex. 132, at 23; Tr. at 596. A podiatrist had last seen Resident 4 on March 25, 1998. CMS Ex. 132, at 23. At that time, he had long, thick nails with the fifth toenail of the left foot growing into the fourth toe and causing an ulcer. Id.; Tr. at 595. Surveyor Mattern testified that she spoke with two nurses about Resident 4 during the survey. Tr. at 596. The nurses indicated that they knew about the condition of his toenails but had not arranged for him to be seen by a podiatrist. Id. Surveyor Mattern testified that Resident 4's long, thick, curling toenails had the potential to cut or press into the flesh of adjacent toes, causing skin breakdown and infection. Tr. at 596-597. She testified that by allowing Resident 4's nails to grow to the point that they were pressing into the flesh of adjacent toes, Rehab had failed to provide Resident 4 with the necessary care and services to maintain his highest practicable physical well being. Tr. at 596. In short, there is evidence that Resident 4 had a standing physician's order for podiatry services to be furnished when necessary, and that Resident 4 needed foot care during December 1998. In addition, it is undisputed that the nursing staff recognized or should have recognized Resident 4's need for foot care but did not act to implement the physician's standing order. Rehab offered no excuse or explanation for that failure. Instead, Rehab contended that "[t]here was no reference to any plan of care that required podiatry services for this resident," and therefore it cannot be charged under section 483.25 with failing to provide treatment or services "in accordance with" with the comprehensive plan of care. Rehab PHB at 48, citing Rehab Ex. 63. We find no merit to this contention for two reasons. First, the exhibit cited by Rehab to support this contention is not the plan of care but merely a record of skin care treatment. The exhibit does not, therefore, establish that podiatry care was not part of the care plan. Second, the unstated assumption underlying this contention is that section 483.25 merely requires the facility to implement measures specified in the resident's plan of care, a proposition we have rejected. As explained above, Rehab may not reasonably rely on its apparent and unexplained failure to incorporate the physician's standing order for podiatry services into the plan of care to establish its compliance with section 483.25. Moreover, one of the specific requirements of section 483.25 expressly states that a facility must ensure that residents receive proper treatment and care for "special services," including foot care. 42 C.F.R. § 483.25(k)(7).
On September 28, 1998, Resident 8, who had diagnoses of depression and dementia, was put on Bentyl, a medication prescribed to relieve abdominal pain. Tr. at 483; CMS Ex. 96, at 3. On November 11, 1998, Resident 8's physician ordered a stool culture to screen for clostridium difficile ("c-diff"), a bacterium believed to have a role in causing diarrhea and colitis. Tr. at 483; see also Merck Manual, ch. 29 (17th ed.). The culture was ordered to rule out c-diff as the cause of Resident 8's abdominal pain. Tr. at 482-83. A December 10, 1998 nursing note indicates that Bentyl was not alleviating Resident 8's abdominal pain. CMS Ex. 96, at 9. Accordingly, on the following day, the physician prescribed Donnatal for breakthrough pain. Id.; see also Tr. at 482. Surveyor Valencia testified that two members of Rehab's nursing staff informed her that the stool culture ordered in November 1998 had not been performed. Tr. at 483. Surveyor Valencia testified that, in her opinion, Rehab had failed to provide Resident 8 with necessary care and services to attain or maintain his highest practicable well-being because it failed to obtain the stool culture ordered by the physician. Tr. at 483. Surveyor Mattern also testified that this failure resulted in actual harm -- namely, the abdominal pain Resident 8 continued to experience after the stool culture was ordered. Tr. at 483-484. Rehab contended that it was in substantial compliance with respect to this resident in part because the physician ultimately cancelled the request for the stool culture. Rehab PHB at 49. This contention implies that CMS was required to show that Rehab had failed to diagnose an actual c-diff infection. However, CMS needed to show only that Rehab's omission was inconsistent with accepted standards of nursing care. CMS's evidence satisfied this criterion. The evidence showed that Rehab failed to perform a test ordered by the physician. Had it been performed, the results would have been used to diagnose the cause -- or rule out a possible cause -- of the resident's abdominal pain and, if necessary, prescribe appropriate treatment. As such, it was a medical service necessary to maintain Resident 8's highest practicable physical well-being. The fact that the physician subsequently cancelled the request for the culture -- the reasons why are not apparent -- did not diminish Rehab's obligation to obtain the culture when it was ordered in November 1998. Rehab contended that the failure to perform the stool culture created no actual harm or potential for harm because at all times Resident 8 received medication that "alleviated" her pain. Rehab PHB at 49. However, the available medical records do not chart the progression of her symptoms during November and December 1998 or indicate the extent to which they had been reduced. Moreover, the fact that a stronger drug was prescribed in December 1998 suggests that her initial prescription, for Bentyl, did not completely control her pain symptoms. Rehab asserted that Resident 8 did not in fact have the c-diff bacterium, but the record does not confirm whether she did or not. The record confirms that the physician cancelled the order for the stool culture shortly after the survey, but there is no evidence that the physician did this because c-diff had been ruled out as the cause of her symptoms. Whether or not this bacterium was in fact the cause of Resident 8's abdominal pain, Rehab's failure to obtain the culture created at least the potential for more than minimal harm because the physician lacked information necessary to prescribe appropriate treatment.
As discussed above, Rehab was not in substantial compliance with section 483.25 during the November survey in part because it had failed to flush and change Resident 1's suprapubic catheter as frequently as ordered by the physician (twice every Tuesday). In her testimony regarding the December survey, Surveyor Valencia testified that she reviewed Resident 1's treatment records and discovered that Resident 1's suprapubic catheter had been flushed only once, not twice (as ordered), on Tuesday, December 8, 1998. Tr. at 485. Surveyor Valencia also testified that, in her professional opinion, there was a potential for more than minimal harm because Resident 1 was at risk for urinary tract infections and that it was, therefore, extremely important to irrigate or flush the catheter to prevent such infections. Tr. at 486. Rehab contended that it was possible that the nurse could have flushed the catheter a second time on December 8 and simply failed to document this event. Rehab PHB at 50. However, a factfinder is not obligated to indulge in such speculation and is entitled to assume, absent contrary evidence, that a resident's medical records accurately reflect the care and services provided (or not provided). Rehab contended that there was no prima facie showing of a violation because Resident 1 did not have a urinary tract infection, the catheter was never plugged, and there was no history of the catheter being plugged. Rehab PHB at 49-50. These assertions imply that noncompliance with section 483.25 occurs only when problems or consequences of failing to comply with a physician order arise or become apparent. However, section 483.25 required Rehab to take the steps necessary to maintain Resident 1's highest practicable well-being. Thus, it was Rehab's obligation to irrigate her catheter in a manner that ensured adequate protection from infection. Surveyor Valencia testified that, in her opinion, flushing the catheter twice every Tuesday was necessary to achieve that purpose and that failing to follow that procedure created a potential for more than minimal harm. Rehab produced no evidence to rebut that testimony.
The SOD for the January survey contains two findings under tag F309. CMS proffered testimony regarding both findings. We address them here, and explain why we conclude that Rehab continued to be out of substantial compliance with section 483.25 at the time of the January survey.
During the January survey, Resident 3, who was 91 years old and totally dependent on the nursing staff to meet her needs, was observed with bruising on her right upper-outer arm. Tr. at 669-670; CMS Ex. 147, at 4. A review of her medical records revealed that she had had the following skin problems during the previous four months:
See Tr. at 669-671; CMS Ex. 147, at 4. The plan of care stated that Resident 3's skin was fragile and tore easily. See Tr. at 671. The plan also referred to "special orders," which were the physician's orders for treating the skin problems that developed. Id. However, according to Surveyor Valencia, the plan identified no measures designed to prevent skin tears or other skin problems from recurring. Tr. at 672. These measures might have included a padded wheelchair, geri-gloves, and protective devices prescribed by an occupational therapist. Tr. at 732-733. Because she found no indication that preventive measures had been considered or implemented, Surveyor Valencia testified that, in her opinion, Rehab had failed to provide Resident 3 with the necessary care and services to attain or maintain her highest practicable well-being. Tr. at 673. Finally, Surveyor Valencia testified that Resident 3 suffered actual harm -- repeated skin tears and at least two skin infections -- as a result of this alleged deficiency. Tr. at 670, 673-674. In its post-hearing brief, Rehab suggested that there was no violation because section 483.25 "assumes that the care plan is appropriate" and that any defect or inadequacy in the plan of care would have resulted in a deficiency finding under a regulation other than 42 C.F.R. § 483.25 (presumably 42 C.F.R. § 483.20(k)), which requires a facility to develop a comprehensive plan of care that includes measurable objectives and timetables to meet the resident's needs). Rehab PHB at 63. Rehab asserted that it fully implemented the plan of care for Resident 3, and that the SOD contained no allegation that the plan of care was deficient. Id. We find these contentions to be unavailing. Rehab's assertion that it fully implemented an adequate plan of care is an attempt to avoid the issue expressly raised in the SOD -- namely, whether the facility "failed to assess why the skin tears/problems were occurring and what potential interventions they could implement to avoid the skin tears/problems." CMS Ex. 142, at 11-12. Rehab did not assert or show that it performed such an assessment, or that it considered the potential efficacy of preventive measures. Nor did Rehab assert that such steps were not necessary to ensure that Resident 3 attained or maintained her highest practicable well-being. In addition, we reject Rehab's suggestion that the surveyors were obligated to allege a violation under section 483.20(k) in lieu of section 483.25. The regulations do not preclude the possibility that a facility's conduct or omissions might violate more than one participation requirement. Rehab asserted that the SOD did not allege "specific treatment or services that were not provided to the resident, which should have been provided." Rehab PHB at 63. We find this omission did not prejudice Rehab because the SOD, as well as Surveyor Valencia in her testimony, made it clear that the basis for the deficiency citation was Rehab's failure to take any steps to prevent the skin tears in question from occurring. In response to this evidence, Rehab did not submit or point to medical records showing the steps it took to prevent skin tears in the areas where they occurred; instead, it merely alleged that the "care plan was being implemented" and that it was "adhering to the physician's orders in the treatment of the resident[.]" Rehab PHB at 63. Consequently, we conclude that Rehab was not in substantial compliance with section 483.25 in its care of Resident 3.
Surveyor Mattern testified about Resident 4 as follows: Resident 4 had a diagnosis of rheumatoid arthritis. His chart indicated that he was to wear a wrist splint from breakfast to dinner and at night while sleeping. A nursing progress note dated December 8, 1998 indicated that he had an open sore on the right wrist. A physician ordered the nursing staff to cleanse the sore with normal saline, apply Bacitracin ointment, and cover the sore with a dressing until healed. The plan of care estimated that the sore, first identified on December 8, would be healed in 30 days (that is, by January 8, 1999). On January 12, 1999, Resident 4 was observed with a wrist splint on his right arm. Treatment for the sore on the right wrist was still being done. On January 13, 1999, a nurse checked the right wrist and found that it was not healed (a fact noted in the nursing progress notes). See Tr. at 751-752. Surveyor Mattern testified that, as of January 13, 1999, Resident 3 was continuing to wear a wrist splint over the open sore on the right wrist and that Rehab had not notified his physician that the sore had not healed despite 30 days of treatment. Tr. at 753-754. Surveyor Mattern also testified that a prudent nurse would have contacted the physician and the therapist who had prescribed or fitted the wrist splint to identify possible reasons why the sore had not healed within the 30-day period thought to be adequate to resolve the problem. Tr. at 754. Based on these circumstances, Surveyor Mattern concluded that Resident 3 did not receive the necessary care and services to maintain his highest practicable physical well-being because no assessment had been done to determine why the right wrist sore had not healed. Tr. at 757. Rehab contended that it had furnished all the treatment as ordered by the physician and suggested that the surveyors had cited it for violating section 483.25 merely because the wrist sore had not healed within 30 days. Rehab PHB at 63-64. Rehab also asserted that there was no evidence that Resident 4's wrist splint did not fit properly. However, these assertions do not undercut CMS's rationale for the deficiency finding, which is that the nursing staff failed to take the steps necessary to determine why the sore had not healed after 30 days. Rehab offered no evidence that it took any such steps prior to the survey, or that such steps were medically unnecessary under the circumstances. We have considered Rehab's other contentions regarding CMS's evidence but find them to be immaterial or without merit.
Section 483.25(a)(2) provides that the facility must, based on the comprehensive assessment, ensure that the resident "is given the appropriate treatment and services to maintain or improve" the "activities of daily living" (ADL) abilities specified in section 483.25(a)(1). 42 C.F.R. § 483.25(a)(2). Section 483.25(a)(1) states that these ADL abilities include the ability to bathe, dress, groom, transfer, ambulate, toilet, eat, and use speech or forms of communication. 42 C.F.R. § 483.25(a)(1). The SOD for the November survey states that Rehab was not in substantial compliance with this requirement because Rehab failed to perform a physical therapy evaluation to properly position Resident 12 in his wheelchair. CMS Ex. 2, at 28-30. Resident 12 (also discussed under tag 309 above) was 54 years old and had had a stroke, which left him weak on his left side and needing a wheelchair. Tr. at 203. He also had a diagnosis of depression. Id. The physical therapist saw Resident 12 on September 18, 1998 and again on October 5, 1998. Id. During the October 5 encounter, the therapist determined that Resident 12 needed, among other things, a physical therapy evaluation for wheelchair positioning and a program for restorative nursing assistant (RNA) care. Id. On November 4, 1998, Surveyor Mattern interviewed the physical therapist, who stated that the wheelchair positioning evaluation had not been performed due to a staffing problem. Tr. at 203-204. Surveyor Mattern also spoke to Resident 12, who stated that his wheelchair was uncomfortable and that he would slide forward or out of the chair. Tr. at 204, 205. Surveyor Mattern testified that in light of the recommendation for a positioning evaluation, Resident 12 might have needed a different wheelchair or a different seat cushion but that, in any event, he had not received "the appropriate treatment and services to maintain [his] functional ability as far as being mobile." Tr. at 205. Surveyor Mattern also testified that Resident 12's avoidance of the uncomfortable wheelchair would lead him to stay in his room, increasing his depression and social isolation. Tr. at 205-206. Rehab did not deny that it was obligated under the regulation to maintain Resident 12's mobility. Nor did it deny that Resident 12 needed the wheelchair positioning and RNA program to maintain his mobility. Instead, Rehab asserted that there was "no time frame referenced on the October 5, 1998 physical therapy statement as to when any evaluation needed to be conducted." Rehab PHB at 26. However, the mere absence of a specified timeframe is insufficient to excuse a month's delay in performing the evaluations needed to properly position this stroke victim in his wheelchair and to design an appropriate RNA program. Rehab also suggested that the deficiency caused no harm because there was "no proof that the resident stayed in his room, did not use the wheelchair or was uncomfortable in that wheelchair." Rehab PHB at 27. In making this suggestion, Rehab implied that CMS must present evidence of actual harm in order to support a finding of noncompliance with a participation requirement. However, CMS need show only a potential for more than minimal harm. Here, Surveyor Mattern gave unrebutted testimony that the deficiency created the potential for such harm, and we see nothing in the record that would permit us to discount it. Furthermore, there was, contrary to Rehab's assertion, proof of Resident 12 being uncomfortable in the wheelchair. As indicated, Surveyor Mattern testified that Resident 12 reported to her that the wheelchair was uncomfortable. This statement is consistent with the resident being weak on his left side and with the physical therapist's recommendation. Rehab presented nothing to indicate that the statement is unreliable. In short, we find that Rehab did not provide Resident 12 with the appropriate treatment and services to maintain or improve his functional abilities, and that this omission created the potential for more than minimal harm. Accordingly, we conclude that Rehab was not in substantial compliance with section 483.25(a)(2) in its care of Resident 12.
Section 483.25(a)(3) requires a facility to ensure that a resident who is unable to carry out activities of daily living "receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene." Resident 1 was an 84 year old female who had a suprapubic catheter and bruises on her arm (see section C.6.a.(i), above) and was dependent on the nursing staff to perform activities of daily living (including grooming and personal hygiene). See Tr. at 68-69, 80, 82; CMS Ex. 183, at 47-48. CMS submitted evidence, including color photographs, that Resident 1 was observed during the survey to have caked brown material built up under long, dirty fingernails, primarily under the thumb and forefingers. See Tr. at 80; CMS Ex. 87, at 7. Surveyor Valencia testified that Resident 1's long, dirty fingernails might cause an infection or gastrointestinal upset were she to touch or handle her catheter, use her hands to eat, or scratch the fragile irritated skin on her bruised arms. Based on the evidence submitted by CMS, we find that Rehab did not ensure that Resident 1 received the necessary services to maintain good grooming and personal hygiene. Rehab did not cite any evidence to rebut CMS's evidence of noncompliance. Nor did it identify any legal error in CMS's deficiency findings. We therefore conclude that Rehab was not in substantial compliance with section 483.25(a)(3) in its care of Resident 1.
Section 483.25(c)
states:
We have held that a facility "must ensure no resident develops pressure sores unless clinically unavoidable and that any resident with pressure sores receives necessary treatment and services for healing, preventing infection and preventing future sores, in order for the facility to meet the overall quality of care requirement to provide what is necessary for each resident to 'attain or maintain the highest practicable . . . well-being.'" Koester Pavilion, DAB No. 1750, at 30 (2002), citing 56 Fed. Reg. 48826, at 48850 (Sept. 26, 1991); Beechwood Sanitarium, DAB No. 1906 (2004). Rehab was cited for violating section 483.25(c)(2) during the November and December surveys.
Resident 11 was re-admitted to Rehab on March 3, 1998 following hip replacement surgery. Tr. at 83. (He had been a resident prior to his hospitalization. CMS Ex. 19, at 18.) A clinical assessment indicates that he had a pressure sore on his left heel when he was re-admitted on March 3. Id.; CMS Ex. 19, at 57. Rehab's "weekly skin documentation records" for March 1998 (CMS Exhibit 19 at 82-88) show that: by March 4, 1998, Resident 11 had developed a stage II pressure sore on his right buttock; by March 16, 1998, he had developed stage III and stage IV pressure sores on his left and his upper tail bone; by March 22, 1998, he had developed a stage II pressure sore on his right heel; and by June 6, 1998, he had developed a stage II pressure sore on his right hand. See Tr. at 84. Surveyor Valencia testified that she interviewed certain members of the nursing staff to determine what measures had been taken to prevent Resident 11 from developing decubitus ulcers. Tr. at 84. Rehab's nursing director, Hank Book, informed her that he was not certain about what preventive measures had been taken for this resident. Tr. at 84-85. Surveyor Valencia testified that, in her opinion, Rehab failed to meet its obligation under section 483.25(c)(2) to provide Resident 11 with necessary treatment and services to prevent new sores from developing after March 4, 1998. Tr. at 87. She also testified that Rehab's failure to provide preventive care and services resulted in actual harm, noting that Resident 11 developed five pressure sores after being admitted to the facility. Id. Rehab contended that CMS failed to make a prima facie showing of noncompliance because it did not specify the treatment or services that the facility should have provided but did not. Rehab PHB at 29. Citing to a batch of medical records (Rehab Exhibit 55), Rehab also contended that it had provided Resident 11 with all necessary preventive care, including periodic laboratory tests, dietary measures, keeping the physician adequately informed, and "turning and repositioning." Id. We find no merit to these contentions. The apparent premise of the survey agency's deficiency finding, and Surveyor Valencia's testimony regarding that finding, is that one can infer, from the fact that Resident 11 had developed pressure sores between March 4 and early June 1998, that Rehab had failed to implement adequate measures to prevent them from occurring. Rehab presented no testimony to challenge the reasonableness of that inference. We find the inference reasonable and sufficient to discharge CMS's evidentiary burden. The burden therefore shifted to Rehab to establish that it had furnished Resident 11 with necessary care and services to prevent new sores from occurring. Rehab did not carry this burden. In particular, the medical records it submitted do not show that it took all of the steps called for in the plan of care or in physician orders to prevent pressure sores from developing. For example, there is a March 3, 1998 order for Resident 11 to wear heel protectors on both heels while in bed. Rehab Ex. 55, at 61. However, we could find no daily treatment logs showing that he wore the heel protectors during March (although treatment logs for subsequent months indicate that he wore the protectors), a measure that might have prevented the right heel ulcer that developed on March 22. Similarly, although some records indicate that the nursing staff received or were about to receive "repositioning training," there are no records confirming that the staff was actually using repositioning techniques to help prevent pressure sores from developing (or worsening) on Resident 11's tail bone or buttocks. Id. at 72. In addition, Rehab did not explain the circumstances surrounding the development of the pressure sore on Resident 11's right hand and what measures, if any, it took to prevent it. The medical records do show that Rehab decided in March 1998 to take measures to improve Resident 11's diet, but, except for the monitoring of albumin levels, there is no evidence that these measures were actually implemented prior to April 1998 (after the sores on his tail bone had reached stage III and stage IV). See Ex. 55, at 5, 23. Rehab suggested that it bore no responsibility for the pressure sores that developed during the three weeks after his re-admission to the facility on March 3. However, it offered nothing to support that position. Rehab also suggested that there was no violation because there was no allegation or proof that Resident 11's plan of care was inadequate. We find no merit to this contention because section 483.25(c)(2) does not indicate that a facility's obligation to provide necessary care is circumscribed by the plan of care. The regulation simply provides that a facility must furnish the services necessary to meet the resident's assessed needs. Because Rehab did not show that it provided Resident 11 with all necessary care and services to prevent pressure sores, we conclude that Rehab was not in substantial compliance with section 483.25(c)(2) in its care of that resident.
Resident 3 was a 97 year old female who had a stage II pressure sore on her right hip. Tr. at 88-89. For this, a physician ordered an occlusive dressing. Id. On November 3, 1998 Surveyor Valencia examined Resident 3's right hip but found no dressing on the sore. Tr. at 89. Surveyor Valencia testified that a failure to apply the dressing had the potential to slow down the healing process, cause the wound to worsen, or subject the wound to infection. Tr. at 90. Rehab offered no credible evidence to explain why the dressing was not on Resident 3's pressure sore when Surveyor Valencia examined it. It submitted only an unsworn statement by Resident 3's granddaughter. Rehab Ex. 48. The statement, dated April 4, 2000, indicated that Rehab had notified the family that Resident 3 had refused to lay on anything but her right side due to arthritic pain, that she was "persistent in removing the dressing on her right hip," and that the family had requested Rehab to not apply the dressing and to allow her to lay on her right side. We give this statement no weight because it is unsworn, written after the survey, and uncorroborated by any contemporaneous medical records. In addition, Surveyor Valencia testified that if the family had requested the dressing to be removed, the nursing staff would or should have contacted the physician to obtain new orders. Tr. at 129. There was no evidence that the physician had been contacted for that reason. Finally, Rehab failed to explain what treatment alternatives it considered to accommodate Resident 3's alleged unwillingness or inability to wear the dressing. Consequently, we conclude that Rehab failed to provide Resident 3 with necessary care and services to promote healing of her pressure sore and was, therefore, not in substantial compliance with section 483.25(c)(2) in its care of this resident.
Resident 4 was an 82 year old male with a diagnosis of cancer who had five pressure sores: on the left second toe, the right buttock, the left buttock, the left outer ankle, and the left outer foot. Tr. at 498-499; CMS Ex. 132, at 3, 15-18. His medical records contain an October 29, 1998 physician order for granulex spray to be administered to the pressure sore on his left outer foot. However, according to Surveyor Valencia, those records contain no documentation -- in particular, a weekly skin assessment sheet -- showing that the nursing staff had regularly monitored the sore to determine whether it was healing. Tr. at 499. On October 26, 1998, the physician discontinued the treatment that had been given for the pressure sores on Resident 4's buttocks. CMS Ex. 132, at 3. That treatment included the application of granulex spray (twice per day). Id. However, the resident's treatment record for December 1998 shows that the nursing staff continued to apply granulex spray during that month despite the physician's order to discontinue that treatment. Tr. at 499-500; CMS Ex. 132, at 14, 20. (Rehab suggests that CMS never established the existence of the physician's order to discontinue treatment because it failed to submit a copy of the order. Rehab PHB at 50-51. However, the existence of the order is documented in Surveyor Valencia's surveyor notes. CMS Ex. 132, at 3. Surveyor Valencia testified under oath that she wrote down the order in narrative format on page 3 of CMS Exhibit 132. Rehab produced no evidence to challenge the veracity of Surveyor Valencia's testimony, the reliability of her observations during the survey, or the accuracy of her notes.) On November 14, 1998, Resident 4's physician ordered Biafin, a dry dressing treatment, to be applied twice per day to the pressure sore on the right buttock. However, between December 5 and December 9, 1998, this treatment was given only once per day instead of twice per day as ordered. Tr. at 500; CMS Ex. 132, at 14. Rehab asserted that the pressure sore did not increase in size during this five-day period. However, it did not deny that it failed to apply the Biafin as ordered. On December 17, 1998, Surveyor Valencia observed and took color photographs of Resident 4's feet, which had long, thick toenails which pressed against his toes and had the potential to cause skin breakdown or pressure sores. Tr. at 501; CMS Ex. 87, at 3-4. Despite his apparent susceptibility to skin breakdown on the toes or feet -- he had been treated for such a problem in May 1998 (see Rehab Ex. 63, at 1; Tr. at 560) -- there was, according to Surveyor Valencia, no padding between the toes in order to reduce contact or friction and thus prevent skin breakdown or pressure sores. Tr. at 501-502. Rehab asserted that there was no evidence of any foot infection or other skin abnormality. Rehab PHB at 51. However, Surveyor Valencia testified that, in her professional opinion, the photographs of Resident 4's toes (CMS Ex. 87, at 3-4) showed heated redness and a sore on the fourth toe, and that these features were evidence of an infection. Tr. at 571-72. Rehab also asserted that there was no physician's order for toe padding, suggesting that a facility's obligation to the resident begins only when it receives a physician's order for treatment. Rehab PHB at 51. However, the regulation puts the responsibility on the facility to ensure that a resident receives necessary care and services. In this case, that meant that, if a physician's order was necessary, Rehab should have contacted the physician for appropriate orders. Otherwise, Rehab should have taken other steps to see that the padding or a reasonable alternative was provided. Rehab offered no evidence that it took any steps to meet this need, however. In addition, Rehab did not rebut Surveyor Valencia's testimony that the deficient treatment of Resident 4 created the potential for more than minimal harm. Based on the evidence submitted by CMS, we conclude that Rehab failed to provide Resident 4 with necessary care and services to promote healing, prevent infections, and prevent new pressure sores from developing and was therefore not in substantial compliance with section 483.25(c)(2).
Section 483.25(d)(2) requires the facility to ensure that a resident who is incontinent of bladder "receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible." The SOD for the November survey states that this requirement was not met for 1 out of 25 residents reviewed because the facility did not ensure that Resident 12 maintained as much bladder function as possible. CMS Ex. 2, at 34. Resident 12 was the 54 year old male who had had a stroke that left him with weakness on the left side of his body. Tr. at 163; CMS Ex. 21, at 1. He also had a history of depression, seizure disorder, and mood disorder-schizo affective with obsessive compulsive disorder traits. Rehab Ex. 53, at 1. The SOD and surveyor focused on several findings regarding Resident 12. First, a September 22, 1998 resident assessment protocol by one nurse shortly after his admission had assessed Resident 12 as being incontinent of bowel and bladder, but also found him to be uncooperative and thus incapable of being retrained to maintain continence. CMS Ex. 21, at 9; Tr. at 163. Yet, his October 1, 1998 comprehensive assessment indicated that he was not abusive or resistive to care, and Surveyor Mattern had found no records other than the September 22 assessment indicating that Resident 12 was uncooperative or incapable of being retrained to achieve continence. CMS Ex. 21, at 3; Rehab Ex. 53, at 6; Tr. at 165. Second, the ADL sheets for October and November 1998 were found to show the resident "was consistently continent of his bowels and at times continent of bladder." CMS Ex. 2, at 34. (CMS relied on this as part of its evidence that Resident 12 was capable of being continent.) Third, at times an adult diaper was placed on the resident which made it difficult for him to use a handheld urinal because of his left-sided weakness. Id.; Tr. at 165. Fourth, the CNA who cared for Resident 12 indicated during an interview with Surveyor Mattern that Resident 12 could stay dry if she left his diaper off and that he could tell the nursing staff when he wanted to use the urinal. Tr. at 164-166. In his interview with Surveyor Mattern, Resident 12 stated that he knew when he needed to urinate. Tr. at 165. Surveyor Mattern testified that when she informed the nursing staff of her findings regarding Resident 12, he was put on a 14-day bladder retraining program. Tr. at 170. After completing the retraining, he was assessed as being continent of bladder (while remaining occasionally incontinent of bowel). Tr. at 172-173; Rehab Ex. 53, at 2. CMS argued that until November 1998, when Resident 12 was put on the formal bladder retraining program, Rehab was not in substantial compliance with section 483.25(d)(2) because it failed to provide him with the services he needed to achieve continence and to restore as much normal bladder function as possible. Surveyor Mattern testified that the harm to the resident was that "he was not able to remain - to be continent. He was laying in either, you know, a wet bed, a wet diaper." Tr. at 170. She said she inferred this from ADL records showing he was incontinent at times. Tr. at 171. She also testified that he stayed in his room a lot, suggesting that this was in part attributable to his incontinence. Tr. at 177. Rehab argued that the formal retraining program was essentially the same as the care and services provided by Rehab before the survey. Rehab argued that there was no allegation that the resident was not taken to the bathroom every two hours or given the care to promote bladder functioning prior to the survey. Rehab pointed out the surveyor had acknowledged that she did not observe Resident 12 wearing a diaper, much less lying in a wet diaper. Tr. at 224-25. Rehab also noted that the CNA had pointed out her awareness that the resident could better use the urinal without the diaper. Rehab pointed out that there was no evidence that Resident 12 had had a urinary tract infection. Rehab also pointed out that the resident had depression before he entered the facility and that this did not change after the formal retraining program. We conclude that a preponderance of the evidence in the record shows that Rehab was in substantial compliance with the requirement. CMS's reliance on the initial assessment that the resident was too uncooperative to be retrained and on the lack of a formal retraining program is misplaced. In spite of the September 22 assessment, the plan of care (completed in late September 1998) called for the nursing staff to bring Resident 12 to the bathroom every two hours and as needed. Rehab Ex. 53, at 13; Tr. at 164. The plan of care begun on November 5, 1998 (which Surveyor Mattern considered a formal retraining program) called for the nursing staff to take Resident 12 to the bathroom every two hours and to offer fluids every two hours. CMS Ex. 53, at 2. Even though offering fluids was not part of a formal retraining program in October, the activity sheets for October 1998 show that he was regularly offered fluids, as well as being assisted to the bathroom or in using a urinal. CMS Ex. 53, at 13, 20, 22, and 24. Assuming that Resident 12's problem was a loss or impairment of normal bladder function, his activity sheets suggest that the measures taken by the staff during October 1998 resulted in a restoration of, or significant improvement in, bladder function. Activity sheets show that the reported episodes of bladder incontinence decreased dramatically during October 1998 -- from 4 or 5 episodes per day between October 1 and October 9, to one or no episodes per day during the last two weeks of the month. See CMS Ex. 53, at 22, 24, 26. This evidence, and the lack of any evidence of a urinary tract infection or of the resident being observed in a wet diaper, undercut any conclusion that Rehab failed to provide "appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible," as required by the regulation. Indeed, the focus of the SOM guidance on this requirement is to look for decline, potential decline, or lack of improvement in functioning, protocols for residents with indwelling catheters, steps to prevent urinary tract infections or other complications, and steps to restore bladder functioning such as pelvic floor exercises, habit training, or maintaining adequate hydration. SOM App. PP (tag F316 guidelines). The record suggests that Resident 12's problem, however, was not a loss of normal bladder function, or an inability to control bladder function, but his need for physical assistance in using the bathroom or a urinal. The record indicates that, prior to the survey, Rehab was providing this assistance and that, after the survey, Rehab took steps to ensure that the urinal was placed where he could use it despite his left-sided weakness. Rehab Ex. 53, at 13. While perhaps Rehab may be faulted for not having formally identified his left-sided weakness as a cause of the incontinence, the ADL records indicate that the facility had identified using the handheld urinal as an option for him prior to the survey. Rehab Ex. 53, at 22, 25. Moreover, the CNA had indicated an awareness of the use of a diaper as a barrier to his using the urinal and had taken the initiative to address this. The resident had been in the facility less than two months at the time of the November survey. CMS would have us infer that, since the formal retraining program was successful in achieving continence in two weeks, the resident would have progressed more than he did during October if the formal program had been initiated sooner. It is more reasonable to infer based on the record as a whole, however, that the success in November was due to the substantial progress made during October and the heightened awareness by staff of needing to take his left-sided weakness into account. For these reasons, we conclude that Rehab was in substantial compliance with section 483.25(d)(2), contrary to what was found during the November survey.
Section 483.25(k)(2) provides that a facility "must ensure that residents receive proper treatment and care for . . . [p]arenteral and enteral fluids[.]" The SOD states that Rehab was not in substantial compliance with this requirement because a nurse failed to follow a facility policy for flushing Resident 7's Groshong catheter. CMS Ex. 142, at 14. Resident 7 was a 67 year old male with diabetes. Tr. at 759. During January 1999, he received intravenous antibiotics for an infection in the right knee. Tr. at 759-60. The antibiotics, which are parenteral fluids, were administered through a Groshong catheter, which is an intravenous line running from the chest wall into one of the large blood vessels just above the heart. Tr. at 760, 761. On January 13, 1999, Surveyors Mattern and Valencia watched a nurse flush the catheter. Tr. at 760. The nurse did this by injecting 5 ccs of saline into the catheter, followed by 3 ccs of heparin (a drug that increases the time it takes for blood to clot), followed by another 5 ccs of saline. Id. Surveyor Mattern testified that, after she observed the flushing procedure, she reviewed Rehab's policy concerning the flushing of a Groshong catheter. Tr. at 760. The policy called for catheter to be flushed with 5 ccs of saline, followed by 3 ccs of heparin. Tr. at 760-61; see also CMS Ex. 152 at 11-12. These procedures were not followed with respect to Resident 7's catheter, according to Surveyor Mattern, because the nurse injected another 5 ccs of saline after injecting the heparin. Surveyor Mattern testified that the applicable "protocol" was to leave the heparin in the line (not flush it away with saline) to prevent blood from clotting and blocking the line, and that flushing away the heparin was not the standard of practice. Tr. at 761-62. Surveyor Mattern also testified that the nurse's failure to follow the policy created the potential for more than minimal harm. She explained that if a blood clot is formed and antibiotics are later administered through the catheter, the clot could be dislodged and carried to the heart, causing a heart attack. Tr. at 762-63. She further explained that, if the catheter becomes "plugged to the point where it can't be flushed out, then it has to be removed and surgically put back in." Id. Rehab did not rebut Surveyor Mattern's testimony that a nurse failed to follow the facility's protocol in flushing Resident 7's catheter. Instead, it asserted that CMS had failed to make a prima facie showing of noncompliance because "there was only a potential that the flushing observed could cause clotting." Rehab PHB at 65 (emphasis in original). We are not sure what point Rehab was trying to make here, in part because the quoted statement is unaccompanied by argument or explanation. In any event, Surveyor Mattern gave uncontradicted testimony that in flushing Resident 7's catheter, the nurse used a procedure that created or increased the risk that a blood clot might form in the catheter and later be dislodged and carried to the heart. Tr. at 761-763, 781. Based on the evidence, we find that Rehab did not ensure that Resident 7 received proper treatment and care for parenteral fluids, and that this deficiency created the potential for more than minimal harm. Accordingly, we conclude that Rehab was not in substantial compliance with section 483.25(k)(2) in its care of Resident 7.
Section 483.25(m)(2) requires a facility to ensure that residents are free of any "significant medication errors." Guidelines in the SOM define a "medication error" as the "observed preparation or administration of drugs or biologicals which is not in accordance with" (1) physician orders, (2) manufacturer's specifications, or (3) accepted professional standards and principles. CMS Ex. 171, at 2. The guidelines instruct surveyors to consider three factors in determining whether a medication error is "significant": (1) the category of the drug; (2) the condition of the resident; and (3) the frequency of the medication error. Id. The guidelines explain that the relative significance of a medication error is a "matter of professional judgment." Id. at 3; see also 56 Fed. Reg. 48,826, 48,853 (Sept. 26, 1991). The medication errors alleged in the November survey concern Resident 8. On September 28, 1998, a physician ordered Dicloxacillin (an antibiotic), 250 milligrams, P.O. (by mouth), QID (four times per day), for 30 days -- a total of 120 pills -- to treat Resident 8's chronic skin infection, which was infectious in nature. Tr. at 391, 394, 417; CMS Ex. 25, at 1, 2, and 4. During the November survey, Mr. Henry Martin, a health facility evaluator for CDHS, reviewed Rehab's Medication Administration Record (MAR) for Resident 8's 30-day course of antibiotic treatment (which ended on October 28, 1998). Mr. Martin testified that on the MAR he found a yellow note, dated October 28, 1998, indicating that 19 of the 120 Dicloxacillin pills prescribed by the physician had been left over from the 30-day treatment period. Tr. at 391-92. He testified that Resident 8 had refused to take the medication on only four occasions during that period, and that the administering nurse was supposed to document these refusals by circling his or her initials on the MAR for the dose in question. Tr. at 393, 403. Mr. Martin testified that he interviewed Jane Musser, a licensed vocational nurse, who confirmed that she had written the yellow note attached to the MAR and that there were in fact 19 Dicloxacillin pills left over from the 30-day treatment period. Tr. at 393, 483. Mr. Martin also testified that he interviewed Rehab's nursing director, who indicated that the leftover pills represented a significant medication error. Tr. at 392. Mr. Martin testified that his findings led him to conclude that a significant medication error had occurred and that the error had the potential for more than minimal harm because the level of antibiotic in Resident 8's bloodstream "would be diminished and possibly be ineffective causing possibly another course of antibiotics with its accompanying risk and benefits" and prolonging the healing process. Tr. at 395. Lori DeMartini, Pharm. D., CDHS's chief pharmaceutical consultant, testified that Dicloxacillin needed to be given for its full (30-day) duration, as prescribed, to ensure that the infection was completely cleared and to eliminate the risk of developing a "superinfection" unresponsive to conventional antibiotics. She concurred with the survey team that a failure to administer 15 of 120 doses (an error rate of 12.5%) under these circumstances was indeed a significant medication error. Tr. at 417-419, 426-27. Based on the evidence just described, we conclude that Rehab was not in substantial compliance with section 483.25(m)(2) in its care of Resident 8. We find no merit to Rehab's contentions regarding this deficiency. For example, Rehab asserted that if there was a medication error, it was not significant and posed no risk of anything more than minimal harm. Rehab PHB at 33. However, Rehab submitted no evidence to rebut the professional opinions of Mr. Martin and Dr. DeMartini (a doctor of pharmacy) that the errors were significant, and we can find no basis in the record to discount those opinions. Rehab contended that it was in substantial compliance because there was no evidence that the potential adverse consequences identified by Surveyor Martin were "likely" to occur, no evidence that the level of antibiotic in Resident 8's bloodstream "was not within an acceptable range for this resident," and no evidence that Resident 8 "developed an antibiotic resistant strain." Rehab PHB at 34. As we have indicated elsewhere in this decision, CMS need not show that a deficiency caused actual harm in order to establish that a facility was not in substantial compliance with a participation requirement. Consequently, CMS was not required to prove that Resident 8 developed a drug-resistant infection. Nor was it required to demonstrate that the adverse consequences were "likely" to occur under the circumstances. CMS needed only to establish that the deficiency had the potential for more than minimal harm -- in other words, that the deficiency was capable causing harm under the circumstances. CMS provided expert testimony that Rehab's failure to administer 19 of 120 Dicloxacillin doses had the potential for such harm, and Rehab provided no evidence to the contrary. Rehab asserted that, given Resident 8's history of refusing medication, it is "more than likely than not that the resident refused to take this medication on other occasions as well." Rehab PHB at 33. In addition, Rehab faulted the surveyor for not asking Resident 8 or the nursing staff whether he had refused the medication more often than four times. We decline to address Rehab's assertion regarding the conduct of the survey. We have said that the "appeals process is not intended to review the conduct of the survey but rather to evaluate the evidence of compliance regardless of the procedures by which the evidence was collected." Beechwood Sanitarium, DAB No. 1906, at 44 (2004). In this case, the survey agency found, and CMS submitted credible evidence, that Resident 8 had not been given 19 out of 120 doses of Dicloxacillin during October 1998, that only four of those 19 doses were documented on the MAR as having been refused, and that the medication error was significant and created the potential for more than minimal harm. This evidence constitutes a prima facie showing of noncompliance with section 483.25(m)(2). Because CMS made this prima facie showing, it was Rehab's burden to establish -- by, for example, introducing evidence of additional medication refusals by Resident 8 -- that a medication error had not occurred. It offered no such evidence. Instead, it essentially asked the ALJ to speculate, based on an alleged "history" of medication refusals, that Resident 8 had refused to take Dicloxacillin on more than four occasions during October 1998. Such speculation is insufficient to meet Rehab's evidentiary burden. Rehab also asserted that there was a "strong likelihood" that Resident 8 refused the medication a fifth time, on October 23. As indicated, such a refusal is supposed to be documented by circled initials on the MAR. However, the MAR entries for October 23 contain no circled initials, only three sets of uncircled initials and a blank space for the 12:00 p.m. entry. Rehab offered no explanation for the blank 12:00 p.m. entry or evidence that it, in fact, represented a refusal to take Dicloxacillin at that time. For the reasons above, we conclude that Rehab was not in substantial compliance with section 483.25(h)(2) in its care of Resident 8.
Section 483.45(a)(1) of the regulations requires that a facility must provide specialized rehabilitative services -- such as physical therapy, occupational therapy, or speech therapy -- if those services are required in the resident's comprehensive plan of care. 42 C.F.R. § 483.45(a)(1). The SODs for the November and December surveys cited five findings under section 483.45(a)(1). See CMS Ex. 2, at 39-42; CMS Ex. 85, at 23-24. CMS addressed only two of those findings at the hearing, one from each survey.
Resident 12 was admitted to Rehab on September 18, 1998. Tr. at 207. As noted above, he had recently suffered a stroke, which left him with weakness on the left side. CMS Ex. 21, at 1. Upon admission, he had a physician's order for physical therapy, occupational therapy, and speech therapy evaluations. Tr. at 207-208; CMS Ex. 21, at 4. Surveyor Mattern testified that when she reviewed Resident 12's charts on November 4, 1998, she found no documentation that he had been evaluated by a speech therapist or an occupational therapist. Tr. at 208-209. A physical therapist saw Resident 12 on September 18, 1998 and again on October 5, 1998. Tr. at 203. During the October 5th screening, the therapist determined that Resident 12 needed, among other things, a wheelchair positioning evaluation. Id. On November 4, 1998, Surveyor Mattern interviewed the physical therapist, who stated that the wheelchair positioning evaluation had not been performed due to a staffing problem. Tr. at 203-204. Surveyor Mattern also spoke to Resident 12, who stated that his wheelchair was uncomfortable and that his buttocks would slide forward when he sat in it. Tr. at 204. Surveyor Mattern testified that, in her opinion, Rehab failed to comply with section 483.45(a)(1) because it did not provide Resident 12 with the wheelchair positioning and the initial speech therapy and occupational therapy evaluations. Tr. at 209. Surveyor Mattern also testified that the failure to provide these services had the potential for more than minimal harm, including uncorrected deficits in speech, swallowing, and physical functioning, as well as increased social isolation and depression. Tr. at 206, 209-211. Rehab suggested that there was no deficiency because Resident 12 had no need for speech or occupational therapy. Rehab PHB at 35. However, other than Surveyor Mattern's responses on cross-examination that she lacked knowledge about whether Resident 12 had difficulties with speech, swallowing, or performing activities of daily living, Rehab identified no evidence to support its assertion that he had no need for such therapy. The spaces for screening Resident 12 for occupational and speech therapy needs on admission are left blank on the "Rehabilitation Screen" form Rehab used. CMS Ex. 21, at 6. Moreover, the key issue here is not whether Resident 12 needed or did not need certain modes of therapy. The issue is whether Rehab furnished the specialized services the resident's physician had determined were necessary to evaluate his need for further therapy services. The undisputed evidence is that Rehab failed to provide Resident 12 with these evaluation services. Rehab contended that CMS failed to make a prima facie showing of noncompliance because there was no evidence that Resident 12's plan of care required it to provide the therapy evaluations. Rehab PHB at 34. However, it is reasonable to assume, absent evidence to the contrary, that a physician's written order for evaluation, and written recommendations for treatment or evaluation made by skilled therapists pursuant to a physician's order, are considered part of resident's comprehensive plan of care. Cf. 42 C.F.R. §§ 483.20(b); 483.20(k). In any event, since the facility must ensure that each resident receives care and services necessary to attain and maintain the highest practicable level of well-being, the regulations cannot reasonably be read as permitting a facility to evade the obligation to provide any needed specialized services simply by failing to timely evaluate what services are needed and/or by failing to incorporate them into the comprehensive care plan. With respect to Resident 12, there is no evidence that the physician rescinded the order for therapy evaluations, but there is evidence that Rehab failed to follow through on those orders. Based on the foregoing facts and evidence, we conclude that Rehab was not in substantial compliance with section 483.45(a)(1).
Resident 6 was a 79 year old male diabetic with organic brain syndrome and a history of a right rib fracture. CMS Ex. 94, at 5. In June 1998, he received physical, occupational, and speech therapy screenings. Tr. at 503. His therapists recommended that he be re-evaluated in three months - during September 1998. Id. Surveyor Valencia testified that she had found no documentation that Resident 6 was re-evaluated in September (or thereafter). Tr. at 504. She also testified that, in her professional opinion, the failure to re-screen Resident 6 in September 1998 had the potential for more than minimal harm -- namely, the possibility of a decline in physical or speech function. Tr. at 504-505. She noted that his therapists would not have recommended re-screening unless there was a potential for such a decline. Tr. at 505. Rehab contended that these facts do not show noncompliance with section 483.45(a)(1) because there is no evidence that Resident 6's plan of care required the therapy re-screenings. Rehab PHB at 54. However, we reject this contention for the reasons discussed above. Rehab also contended that the deficiency, if there was one, did not cause or have the potential to cause anything more than "minimal harm" because there was no documented decline in function, and no evidence of the potential for such a decline. Rehab PHB at 54-55. However, Surveyor Valencia testified that Resident 6, given his neurological diagnosis (organic brain syndrome) and history of bone fracture, was at risk for a decline in function. Tr. at 505. Her testimony on this point is consistent with the other evidence of record, and we find no basis in the record to discount it. Because CMS offered credible testimony that the deficiency caused more than minimal harm, the burden was on Rehab to submit evidence that it was in substantial compliance with section 483.45(a)(1). Rehab proffered no such evidence. Rehab also contended that the surveyor "went back to records as early as of June of 1998, prior to even the date of the first [November] survey, and prior to the date of the plan of correction (for the first survey), to find a deficiency." Rehab PHB at 55. Rehab did not explain how or why these actions are illegal or improper, or how they invalidate the survey agency's findings regarding Resident 6. In addition, CMS may properly find, based on evidence of incidents or circumstances that occurred prior the survey, that a facility is not currently in substantial compliance if there is no reason to be believe that the facility has corrected the noncompliance. See Regency Gardens Nursing Center, DAB No. 1858, at 10 (2002)(a deficiency may be evidenced by events that occurred prior to the actual survey date). Here, Rehab did not allege or show that it came into substantial compliance with section 42 C.F.R. § 483.45(a)(1) prior to the November survey.
Section 483.60(a) of the regulations requires a facility to provide pharmaceutical services -- including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals -- to meet the needs of each resident. The SOD for the November survey sets out five general findings related to this requirement. CMS argued that each was a separate deficiency sufficient to show noncompliance. While we do not agree with this position, we conclude for the reasons stated below that Rehab was not in substantial compliance with section 483.60(a) and that it had systemic problems in this area.
Resident 13 had a physician's order for Aricept, a drug used to treat mild to moderate cognitive dysfunction secondary to Alzheimer's disease. Tr. at 213, 429; CMS Ex. 22, at 1, 6. When Surveyor Mattern reviewed the Medication Administration Record (MAR) to determine if this medication had been administered daily as ordered, she determined that Aricept had not been given to Resident 13 on three days during May 1998 (on May 15, May 27, and May 28) because it had not been received from the pharmacy. Tr. at 213-214; CMS Ex. 22, at 6-7; see also Tr. at 429. Loriann DeMartini, the doctor of pharmacy called by CMS, testified that Rehab violated standards of practice for the accurate receiving of drugs because Resident 13's Aricept was not available to be administered in a timely fashion in accordance with the physician's orders. Tr. at 428-431. Dr. DeMartini also testified that it is ultimately the nursing facility's responsibility to ensure that medications are timely obtained, dispensed, and administered. Tr. at 431. Dr. DeMartini also testified that, in her professional opinion, Rehab's failure to administer the Aricept on three days during May 1998 created the potential that Resident 13 might not reap the therapeutic benefit from the drug, leading to worsening of his cognitive status. Tr. at 431-433. Based on the foregoing facts and evidence, we find that Rehab was not in substantial compliance with section 483.60(a) because it failed to provide pharmaceutical services to meet the needs of Resident 13. Rehab contended that CMS failed to present a prima facie case of noncompliance because it proffered no evidence that Aricept's unavailability on May 15, 27, and 28 stemmed from inadequate procedures or recordkeeping. Rehab PHB at 35-36. Rehab also hinted (without pointing to any evidence) that the pharmacy was responsible for the problem. Id. at 36. We reject these contentions. Section 483.60(a) requires the facility to provide pharmaceutical services to meet each resident's needs. By stating that necessary pharmaceutical services "include" the "procedures" for assuring accurate acquiring, dispensing, and administration of drugs, section 483.60(a) implies that the term "services" refers to things other than procedures, including the facility's practices with respect to individual residents. Here, the fact that Aricept was unavailable to Resident 13 during a period when he had been taking it regularly is sufficient proof that Rehab failed to provide the necessary pharmaceutical services to meet his needs, as required by section 483.60(a). It was therefore Rehab's burden to rebut this showing by presenting evidence that its procedures for acquiring the drug were adequate under the circumstances and were followed by its employees, and that the drug's unavailability was due to circumstances beyond its control. Rehab offered no such evidence. Rehab also contended that there was no potential for anything more than minimal harm, noting the absence of evidence that Resident 13's blood had less than a therapeutic concentration of Aricept. Rehab PHB, at 36. We reject this contention. As we have indicated in our discussion of other deficiencies, CMS was required to show only a potential for more than minimal harm, not a high or substantial likelihood that harm actually resulted. In any event, Rehab offered no evidence whatsoever to rebut Dr. DeMartini's testimony that there was a potential for more than minimal harm. Moreover, one can infer from the physician's order that the physician had determined that one dose per day was the amount the resident needed to maintain a therapeutic level. We have considered Rehab's other contentions regarding this deficiency and find them to be without merit.
Resident 5, an insulin-dependent diabetic, had a physician's order for daily insulin, to be administered on a sliding scale when his blood sugar level reached certain levels at certain times of the day. See Tr. at 215; CMS Ex. 20, at 6. Surveyor Mattern testified that when she reviewed Resident 5's MAR, she found three instances in which Rehab failed to administer insulin to Resident 5 when his blood sugar levels called for it. Tr. at 215-216. She testified that: (1) on October 26, 1998 at 11:30 a.m., when his blood sugar level was 200, Resident 5 should have been given two units of regular insulin; (2) on October 27, 1998, at 4:30 p.m, when his blood sugar level was 250, he should have been given four units of regular insulin; and (3) on October 29, 1998, at 8:00 p.m., when his blood sugar level was 220, he should have been given four units of regular insulin. Id. Nursing records fail to document that Resident 5 was given the required units of insulin on these three occasions. Tr. at 216; CMS Ex. 20, at 7-8. Dr. DeMartini testified that Resident 5 was probably a "brittle" diabetic whose diabetes was continually out of control, requiring intensive therapy and monitoring to keep his blood sugar within an acceptable range. Tr. at 434-435. She also testified that a failure to administer the insulin at the proper times was a failure to assure accurate "administration" of the insulin. Tr. at 433. Dr. DeMartini and Surveyor Mattern both testified that, in their professional opinions, Rehab's failure to administer insulin to Resident 5 on three occasions in accordance with his physician's order created a potential for more than minimal harm because it increased the risk of secondary complications related to his diabetes, including skin infections, vascular abnormalities, blindness, renal failure, and death. Tr. at 216-217, 434. Based on the foregoing facts and evidence, we find that Rehab failed to provide pharmaceutical services to meet Resident 5's needs during October 1998 and was therefore not in substantial compliance with section 483.60(a). Rehab suggested that the surveyors should have interviewed the nursing staff to confirm what was apparent from Resident 5's treatment and medication records - namely, that insulin was not administered when required. Rehab PHB at 36. However, because there is no evidence that those records were inaccurate or incomplete, they are sufficient to establish that Resident 5 did not receive insulin on the dates in question. Rehab asserted that it was "more likely than not" that the insulin was given on the three occasions mentioned because Resident 5's blood sugar had dropped on those days. Rehab PHB at 36. Rehab also asserted that Resident 5 did not suffer any diabetic complications. However, Rehab failed to identify or submit any evidence that Resident 5's blood sugar levels had been promptly brought under control, or that reductions in his blood sugar levels on those occasions were probably due to timely administrations of insulin. The fact that Resident 5 suffered no complications is irrelevant because the noncompliance finding is based on evidence of a potential for more than minimal harm.
Surveyor Mattern testified that during her November 4, 1998 inspection of a medication room near nursing station 2, she found on the shelves a bottle of buffered aspirin with an expiration date of October 1998. Tr. at 217. Also, she found in a refrigerator a box of Compazine suppositories with an expiration date of October 16, 1998, and two multi-dose vials of insulin with expiration dates of October 6, 1998. Id. Surveyor Mattern testified that by storing these medications whose expiration dates had passed, Rehab failed to have procedures to assure that they were accurately dispensed or administered. Surveyor Mattern also testified that this deficiency posed a risk of more than minimal harm because manufacturers do not guarantee the potency or effectiveness of their drugs after the expiration date. Consequently, she said, a patient who takes a drug after its expiration date may not receive any therapeutic benefit. Id. at 217-218. Dr. DeMartini testified that a component of "receiving" a drug is that it be stored in a manner that maintains its potency and purity, and that storing medications beyond their expiration dates does not assure accurate receiving of medications. Id. at 436. Dr. DeMartini also testified that when an expired drug is administered, there is a risk that the patient will be exposed to toxins caused by the drugs biodegradation. Id. at 435-436. Rehab contended that the evidence submitted regarding this deficiency does not constitute a prima facie showing of noncompliance because the items in question were never dispensed or administered to anyone, because there was no evidence that they would have been dispensed or administered to anyone, and because there was no evidence that facility staff would not have checked the expiration dates prior to using them. Rehab PHB at 36-37. Accepting for the sake of argument Dr. DeMartini's testimony that accurate "receiving" of drugs requires that drugs be stored in a manner that maintains their potency and purity, we do not see how the evidence presented by CMS warrants a deficiency finding. There was no evidence that the items were improperly stored, only evidence that they continued to be stored in a medication room shortly after their expiration dates. Dr. DeMartini did not testify as to a professional standard of quality establishing how often a medication room should be purged of expired drugs. In addition, the mere discovery of expired drugs in a medication room does not support a finding that Rehab failed to assure that drugs were accurately "dispensed" or "administered." At a minimum, the regulation required CMS to present some evidence from which we could infer that leaving the expired drugs in the medication room posed more than the mere possibility that they might actually be dispensed or administered, such as evidence that Rehab had no procedure to check expiration dates before drugs were dispensed or that expiration dates were not, in fact, checked prior to drugs being dispensed. No such evidence was offered. Consequently, we conclude that this set of circumstances, by itself, does not evidence a failure to comply with section 483.60(a).
Resident 25 had an order for Citracal, a calcium supplement, to be taken four times daily. Medication records indicate that Resident 25 was not given her dose of Citracal at 9:00 a.m. and 1:00 p.m. on May 28, 1998. Tr. at 218. Surveyor Mattern and Dr. DeMartini testified that these facts establish that Rehab failed to assure the accurate "receiving" of Citracal so that it could be administered to Resident 25 in timely fashion in accordance with the physician's order. Tr. at 218, 437, 470. Surveyor Mattern testified that there was a potential for more than minimal harm because not receiving the supplement "could lead to" osteoporosis (weakening of the bones). Tr. at 219-220. We conclude that CMS failed to make a prima facie case, with respect to Resident 25, that there was a potential for more than minimal harm from Rehab's failure to give the Citracal as ordered. We agree with Rehab that the potential for harm was speculative because there was no evidence as to why Resident 25 was taking the supplement. Although Surveyor Mattern assumed that it had been prescribed to prevent bone loss, she did not assert that the physician had in fact prescribed it for that reason. See Tr. at 218-219, 436-438. Dr. DeMartini testified that the magnitude of the harm or potential harm would "depend on whether [the substance] was a simple dietary supplement . . . or if it was being used to mitigate the potential for osteoporosis." Tr. at 470. In its briefs, CMS did not assert that Resident 25 was taking Citracal to address a particular diagnosis or medical condition, nor did CMS cite to any evidence about why Resident 25 was taking it. While there is insufficient evidence that the alleged deficiency created the potential for more than minimal harm, however, the undisputed failure to give the Citracal as ordered supports an overall conclusion that Rehab was not in compliance with section 483.60(a) and that this was a systemic problem.
Resident 1 had Alzheimer's disease and senile dementia. Tr. at 40. She had a May 27, 1997 physician's order for Vitamin E, to be given orally, twice a day, and a September 18, 1997 order for Ativan, to be given twice a day. Tr. at 91; CMS Ex. 183, at 3 and CMS Ex. 14, at 1. Surveyor Valencia testified that Resident 1's MARs showed that that she did not receive her Vitamin E on May 22, 1998, June 6, 1998, and June 7, 1998 because it was "not available" (according to the MARs). Tr. at 91-92; CMS Ex. 14, at 5. The MARs also indicated that Resident 1 did not receive her Ativan on June 7, 1998 or on August 8, 1998 because it was "not in stock" according to nursing medication notes. Tr. at 92; CMS Ex. 84, at 1, 3. Dr. DeMartini testified that the unavailability of Vitamin E (a dietary supplement) and Ativan (a sedative used to treat anxiety) on those dates showed that Rehab had failed to assure the accurate acquiring of those drugs. Tr. at 438-439. Dr. DeMartini also testified that Rehab's failure to have Ativan available created the potential for more than minimal harm. She explained that because Ativan is a short-acting drug that is dosed several times a day, a patient with an anxiety disorder who fails to receive the drug on a given day may experience symptoms of that disorder, including fearfulness and crying. Tr. at 441. Surveyor Valencia testified that taking Vitamin E promotes healthy skin, and that a failure to give Vitamin E as ordered had the potential to reduce the health of Resident 1's skin, particularly given the extensive bruising on her arms. Tr. at 92-93. She later noted that Resident 1 had chronic itching of the legs and trunk and that the combination of Ativan and Vitamin E would have been "mighty important" to treat that condition. Tr. at 134. Rehab offered no evidence to rebut the testimony that Rehab failed to accurately acquire Ativan and Vitamin E and that its failure to have these substances available for Resident 1 created a potential for more than minimal harm. Rehab suggested that a violation of section 483.60(a) had not occurred because there was no evidence that Resident 1 experienced an increase in anxiety or that her skin was not, in fact, well on the days in question. Rehab PHB at 39. We find no merit to these contentions because CMS was not required to show actual harm. In sum, while the record does not support all of CMS's conclusions, the record clearly supports a conclusion that Rehab was not in substantial compliance with section 483.60(a) and that this was a systemic problem.
As discussed in the ALJ Decision, a facility must establish an "infection control program" under which it (1) investigates, controls, and prevents infections, (2) decides what procedures, such as isolation, should be applied to an individual resident, and (3) maintains a record of incidents and corrective action. See 42 C.F.R. § 483.65(a). In addition, section 483.65(b) of the regulations requires the facility to isolate a resident when its infection control program determines that he or she needs isolation to prevent the spread of infection. The SOD states that Rehab failed to comply with this requirement because it failed to place Resident 5 and Resident 27 in "contact isolation" to prevent the spread of scabies. The policies and procedures for Rehab's "infection control program" were contained in a manual that set forth (among other things) guidelines from the Centers for Disease Control and Prevention. Tr. at 179. These guidelines called for Rehab to put a person with scabies in contact isolation for 24 hours after the start of treatment for that condition. Tr. at 179-189, 194-195; CMS Ex. 42, at 5. Residents 5 and 27 were treated for scabies on October 21, 1998. Tr. at 177-178. Surveyor Mattern testified that she interviewed the CNA who cared for Residents 5 and 27 as well as Rehab's infection control nurse and that both individuals told her that these residents had not been put in contact isolation for 24 hours after the start of treatment, as required by the facility's infection control manual and section 483.65(b). Tr. at 195-196. Surveyor Mattern also testified that the failure to isolate these residents created the potential that scabies would be spread to other residents. Tr. at 196. Surveyor Mattern also testified about positive skin scrapings taken from another resident, Resident 33, indicating that scabies was a problem in the facility. Tr. at 183; see also Rehab Ex. 35, at 1. Rehab contended that it was in substantial compliance with section 483.65(b) because its "infection control program" did not determine that these residents needed isolation. Rehab PHB at 40. However, the policies, procedures, and guidelines contained in the infection control manual were part of Rehab's infection control program. They required isolation of a resident for 24 hours after the beginning of treatment for scabies and did not require the facility to make a case-by-case determination of resident's need for isolation separate from a determination to start treatment. It is undisputed that Resident 5 and Resident 27 started treatment for scabies on October 21, 1998. Having started that treatment, they were required by the program to be placed in contact isolation. Rehab offered no evidence that its program required anything less. Rehab asserted that there was no violation because Residents 5 and 27 did not, in fact, have scabies. Rehab PHB at 40. However, the evidence Rehab cited, which included testimony by Surveyor Mattern, does not support this assertion. Surveyor Mattern acknowledged on cross-examination that Resident 5 and Resident 27 did not have "positive skin scrapings." Tr. at 241. However, she indicated that the infection control nurse, Alane Fife, had determined that these residents did indeed have scabies and were treated for that reason. Id. Rehab offered no testimony to explain Nurse Fife's determination, and therefore, it is reasonable to infer that it was medically warranted. In addition, we note that the treatment record cited by Rehab (Rehab Ex. 35, at 1), which has information about Resident 27 (but not Resident 5), indicates that there were no "positive skin scrapings" for that resident because scrapings were not done. See Rehab Ex. 35, at 1; CMS Ex. 54, at 1. This suggests that Nurse Fife's determination could have been based on observable signs or symptoms of the infection. Based on the testimony and other evidence submitted by CMS, which Rehab did not rebut, we conclude that Rehab was not in substantial compliance with section 483.65(b) in its care of Resident 5 and Resident 27.
Section 483.75 provides that 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. We have held that a finding of noncompliance under section 483.75 may be based on evidence of other deficient practices, especially those practices that affect a resident's safety, quality of life, and quality of care. See Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 16 (2002)("the existence of independent deficiencies may constitute a prima facie case that a facility has not been administered efficiently or effectively as required by section 483.75"); Asbury Center at Johnson City, DAB No. 1815 (2002); SOM Appendix PP (instructing surveyors, under tag F490, to review deficiencies cited under 42 C.F.R. §§ 483.13, 483.15, and 483.25). Here, CMS established that Rehab had numerous deficiencies implicating resident safety, quality of life, and quality of care, including: (1) multiple failures to provide necessary care and services (tag F309); (2) a failure to report alleged mistreatment, neglect, or abuse to the facility administrator (tag F225); (3) a failure to consult with a resident's physician following a significant change in the resident's condition (tag F157); (4) a failure to ensure that residents received adequate supervision to prevent accidents (tag F324); and (5) a failure to implement or maintain an effective pest control program (tag F469). Also, Surveyor Mattern testified, and the SOD indicates, that in-service training furnished to Rehab's licensed nurses pursuant to the plan of correction for the November survey was inadequate or incomplete in certain respects. See Tr. at 600-604; CMS Ex. 120, at 1-2; CMS Ex. 85, at 28. In addition, CMS established that when the first revisit survey was conducted in late December 1998, Rehab had not brought itself into substantial compliance with certain participation requirements (see the discussion above and in the ALJ Decision regarding tags F309, F157, and F225) despite knowledge of the November survey's deficiency findings regarding those requirements. This fact, coupled with the cited shortcomings in the facility's in-service education, is some evidence that Rehab was not deploying its resources effectively to ensure that the needs of its residents were met in a timely and consistent way. Rehab asserted that "there is no allegation in the [SOD] that there was anything wrong with the in-service training." Rehab PHB at 56. However, it is obvious from the SOD what the survey agency thought was inadequate. CMS Ex. 85, at 28. For example, the SOD found that the in-service on December 3, 1998 addressed 28 issues in 60 to 70 minutes and that the in-service for the interdisciplinary team regarding care plan issues was not completed. Id. Rehab offered no evidence to rebut the SOD's findings regarding in-service training. We considered Rehab's other contentions regarding this deficiency but found them to be without merit. Based on the foregoing evidence and findings, we conclude that Rehab was not in substantial compliance with section 483.75.
A facility may provide nursing, therapy, or other services either by employing a person to provide those services, or by obtaining the services from another person or entity outside the facility. See section 1819(b)(4)(A) of the Act; 42 C.F.R. § 483.75(h)(2). Section 483.75(h)(2)(i) of the regulations provides that agreements or arrangements pertaining to services furnished by outside resources must specify in writing that the facility assumes responsibility for "[o]btaining services that meet professional standards and principles that apply to professionals providing services in such a facility." Rehab had a contract, dated May 1, 1996, with a company called Option Care. CMS Ex. 152, at 5; Tr. at 768. The contract stated that Option Care was to provide Rehab residents with intravenous (IV) medication and other IV therapy services. CMS Ex. 152, at 5-6. The contract also stated, in section 1.5, that Option Care was to provide in-service education to Rehab's professional nursing staff concerning the management and care of IV therapy patients. Id. at 6. In addition, section 3.1 of the contract provided that Rehab and Option Care were to meet "on a regular basis, as often as deemed necessary and appropriate," to discuss the services being provided under the contract. Id. at 7. Surveyor Mattern testified that, when asked, Rehab could not produce any documentation showing that the in-service education called for by the contract had been provided. Tr. at 768. Surveyor Mattern also testified that Rehab's administrator informed her that the regular meetings called for in section 3.1 of the contract were not held. Id. In addition, Surveyor Mattern noted that on two occasions -- January 1 and January 7, 1999 -- an Option Care nurse failed to follow Rehab's policy, a policy written by Option Care, for flushing Resident 7's Groshong catheter. Tr. at 769. She also testified that Rehab was not in compliance with section 483.75(h)(2)(i) "in that when a facility is attaining [sic] services, those services need to meet professional standards and principles that apply to the professionally provided services and also that the facility . . . assumes the responsibility that these services are provided for accurately." Tr. at 769-770. Finally, Surveyor Mattern testified that Rehab's omissions with respect to the contract had the potential for more than minimal harm. Tr. at 771. Rehab submitted no evidence contradicting Surveyor Mattern's testimony about how its contract with Option Care was implemented. In its request for review, Rehab did not contend that the facts asserted by CMS are insufficient to constitute a violation of section 483.75(h)(2)(i). Nor did Rehab point to any wording in its contract specifying the responsibility it had to assure that the services obtained would meet professional standards and principles. Even if the provisions requiring in-service education and regular meetings could be read as contract terms evidencing that Rehab had assumed responsibility for the quality of the services, Rehab could not reasonably have thought it was in compliance with the regulation if it abdicated its responsibility by failing to ensure that these contract terms were fulfilled. Rehab's failure to "assume responsibility for obtaining services that meet professional standards and principles," as required by the regulation, had the potential for more than minimal harm, as evidenced by Rehab's failure to detect and correct deviations from Option Care's own protocol for flushing a Groshong catheter. We conclude, based on these findings and on the evidence submitted by CMS, that Rehab was not in substantial compliance with section 483.75(h)(2)(i).
Section 483.75(i)(2) provides that a facility's medical director is "responsible for . . . [i]mplementation of resident care policies" and the "coordination of medical care in the facility." The survey agency found, under tag F501, that Rehab was not in substantial compliance with this regulation and found that the scope of this deficiency was "widespread." Surveyor Valencia was the only witness who testified about this alleged deficiency. She testified that various deficiencies under other tags (e.g., tags F157, F225, F309, and F441) were examples of the medical director's failure to "assume responsibility" for implementation of resident care policies and for the coordination of medical care. Tr. at 93-96. On cross-examination, Surveyor Valencia admitted that she had never spoken to the facility's medical director and that the only basis for the deficiency finding under tag F501 was the existence of other deficiencies. Tr. at 135-136. We agree with Rehab that CMS must do more than show the existence of other deficiencies in order to establish noncompliance with section 483.75(i)(2). The regulation states that a medical director is "responsible for" implementation of care policies and coordination of medical care. To say, in this context, that the medical director is "responsible" for these things is to imply that he or she has a duty to perform certain actions in a satisfactory manner or to take steps to ensure that appropriate measures are taken by others. In its post-hearing brief, CMS did not identify a specific instance in which the medical director's actions or inaction with respect to a resident, or to the resident community at large, resulted in or contributed to a failure to implement care policies. Nor did CMS identify an instance in which the medical director failed to coordinate medical care under circumstances where coordination by the medical director was necessary or required. Because it is conceivable that deficiencies may exist despite a medical director's best and reasonable efforts to oversee and supervise the medical care in the facility, the mere assertion by CMS that deficiencies were found to exist on the medical director's watch is insufficient to establish that the medical director failed to assume the specified responsibilities. We recognize that, in some circumstances, the number and nature of deficiencies found might support an inference that the requirement was not met, but we decline to draw such an inference under the particular circumstances here. Similarly, such an inference might be drawn from a failure to timely correct deficiencies related to the medical director's responsibilities. CMS cited this tag in the November survey, however, rather than in the subsequent surveys. Accordingly, we conclude CMS failed to make a prima facie showing of noncompliance with section 483.75(i)(2), based on deficiencies found in the November survey and upheld on appeal.
As noted above, there were a number of deficiencies alleged in the SODs for the three surveys that CMS did not address at the hearing even though Rehab had said that it was contesting all of the alleged deficiencies. CMS did not argue in its posthearing brief that it had provided documentary evidence to establish a prima facie case regarding any of the deficiencies not addressed at the hearing. Rehab pointed out in its post-hearing brief that CMS had presented no documentary evidence regarding those alleged deficiencies and that, even with respect to alleged deficiencies addressed at the hearing, CMS had failed to present any evidence regarding some of the residents discussed in the SODs. Rehab PHB at 3. The ALJ did not address Rehab's contention that CMS had failed to make a prima facie case on the survey findings that CMS did not address at the hearing. In its request for review, Rehab again argued that a number of the survey allegations were wholly unsubstantiated. CMS did not take the position before us that the SODs alone were sufficient to establish a prima facie case. Accordingly, we conclude that CMS failed to make a prima facie case regarding the deficiency findings not addressed at the hearing, and we therefore reverse them. The alleged deficiencies on which CMS presented no evidence related to the following tag numbers (with the assigned level of scope and severity in parentheses):
Twelve of these 25 alleged deficiencies were rated only at the B or C level, so they would not have constituted a failure to substantially comply with the related requirement even if upheld. Thirteen others, however, were rated at higher levels of scope and severity, including two at the F level (widespread with a potential for more than minimal harm, but no actual harm). We also find in Rehab's favor with respect to allegations under other tag numbers regarding residents CMS did not address at the hearing or otherwise. This includes findings under some of the tag numbers that we address above and that the ALJ addressed in his decision. We note, however, that finding in Rehab's favor on these residents does not undercut or nullify the determination that Rehab was not in substantial compliance with respect to the relevant requirements, nor does it undercut the CMS determination about the level of noncompliance with those requirements. With respect to each participation requirement, the determination of noncompliance was supported by other findings contained in the ALJ Decision or in our decision.
As indicated, an assessment of whether the amount of the CMP is reasonable must be guided by the factors specified in (or cross-referenced by) 42 C.F.R. § 488.438(f). CarePlex. Those factors are the seriousness (scope and severity) of the deficiencies, the relationship of any deficiency to other deficiencies resulting in noncompliance, and the facility's history of noncompliance (including repeated deficiencies), financial condition, and degree of culpability. We first address whether the $8,000 per day CMP imposed for the period of immediate jeopardy (November 3 through November 6, 1998) is reasonable. Initially we note that Rehab did not, in this appeal, challenge the immediate jeopardy finding made by the survey agency (and sustained by the ALJ). The factual basis for that finding, as the ALJ found, was three instances of noncompliance with section 483.65(a)(1), which requires a facility to establish an effective infection control program. One of these instances involved a failure to take appropriate action to contain an outbreak of scabies. ALJ Decision at 14-16. A second instance involved a lack of an adequate system for tracking and communicating information about infections, and the third a failure to implement a flu vaccination program. Id. at 16-17. The survey agency found the scope of Rehab's noncompliance with section 483.65(a)(1) to be widespread. We agree with CMS and the survey agency that the noncompliance described under tag F441 was especially serious because it evidenced systemic problems that facilitated, or could have facilitated, the spread of infection and disease to numerous residents. The scope (and nature) of the potential harm from that noncompliance, coupled with the numerous other non-immediate jeopardy level deficiencies found to exist during the four days in question, amply justifies a CMP at the upper end of the applicable penalty range ($3,050 to $10,000 per day). Accordingly, we find that the CMP of $8,000 per day from November 3 to November 6, 1998 was within a reasonable range. We turn next to the $2,500 per day CMP, which ran from November 7, 1998 through February 7, 1999. We find that the number and seriousness of the deficiencies, as well as Rehab's culpability for the noncompliance, are factors that weigh heavily in favor of a substantial per day penalty. During the November and December surveys, surveyors found noncompliance in numerous areas, including infection control, medication administration, staff treatment of residents, protection of residents from accident hazards, and quality of care. Several of the deficiencies addressed by the ALJ resulted in actual harm to residents. They included: two instances, identified during successive surveys, of failing to notify the physician about a significant change in Resident 1's condition (see ALJ Decision at 10-12, 20); two instances, cited in successive surveys and both involving Resident 1, of failing to ensure that possible mistreatment, neglect, or abuse was reported to the proper authorities (see ALJ Decision at 12-13, 21-22); two instances of failing to take reasonable steps to prevent accidents (see ALJ Decision at 22-24); failure to ensure that residents were free from abuse (see ALJ Decision at 24-28); a failure to institute or maintain an effective pest control program (see ALJ Decision at 17-18); and several instances, cited under data tag F309, of failing to provide services that met accepted standards of nursing care (see our findings in section C.6. above). The surveyors found, with respect to seven of the deficiencies CMS addressed at the hearing, that there was a "pattern" of noncompliance. In its post-hearing brief, Rehab contended that the survey agency's findings that certain deficiencies had caused actual harm or constituted "patterns" of noncompliance were erroneous or not supported by the evidence submitted by CMS. In general, when a CMS determination concerning the seriousness of a facility's noncompliance is reviewable, it must be upheld unless clearly erroneous. 42 C.F.R. § 498.60(c)(2). We find no basis to overturn any of the survey agency's scope and severity findings. Rehab did not, in fact, dispute many of the findings of actual harm, much less demonstrate that they were clearly erroneous. In addition, the survey agency's determination (adopted by CMS) that seven of the alleged deficiencies addressed at the hearing constituted patterns of noncompliance is consistent with the findings made or affirmed by us concerning those deficiencies. It is evident from the litany of noncompliance findings discussed in this decision and in the ALJ Decision that Rehab "failed its residents in ways that go to the heart of what is expected from a facility entrusted with the care of ailing, elderly persons dependent on their care-takers." See Pacific Regency Arvin, DAB No. 1823, at 25 (2002). "It is also evident that the consequent sufferings of these residents not only involved actual harm but harm that amounted to serious injury and pain." Id. Rehab had a relatively high degree of culpability for its noncompliance. The evidence as a whole shows at least indifference. There were were patterns of noncompliance, not just isolated deficiencies, evidencing systemic problems. Moreover, Rehab failed to correct its noncompliance between the November and December surveys with respect to seven requirements, including some deficiencies at the actual harm level (tags F157, F225, and F309). Neither tag F157 nor F309, both of which had been cited during the November survey, had been corrected by the January survey. There was also undisputed evidence that Rehab took inadequate steps to implement its plan of correction. See Tr. at 604-606, 654 (discussion of post-survey in-service education). An example of uncorrected noncompliance concerned Rehab's failure to report instances of possible mistreatment, neglect, or abuse. In his findings regarding the November survey, the ALJ determined that the nursing staff had failed to report unexplained bruises on Resident 1 to the facility's administrator, a violation of 42 C.F.R. § 483.13(c)(1)(iii). Despite an assertion in the plan of correction that this deficiency would be corrected by December 4, 1998, the ALJ found that Rehab continued to be out of compliance with section 483.13(c)(1)(iii) during the December survey. See ALJ Decision at 20. In particular, the ALJ found that facility staff had failed to report new instances of unexplained bruising on Resident 1's hands and arms to the facility administrator. See ALJ Decision at 20-21; CMS Ex. 85, at 5. In addition, there was evidence that Rehab still did not have (as of mid-December 1998) a formal or established system for reporting bruising (or, presumably, other possible instances of abuse or mistreatment) to the facility's administrator. See Tr. at 480. These circumstances suggest disregard by Rehab of its obligation under the regulations to ensure the safety and health of Resident 1. Rehab's financial condition does not warrant a reduction in the $2,500 CMP. The documentation in the record concerning this regulatory factor included the unaudited financial statements of Western Care Management Corporation (Western), which owned and operated Rehab (and one other skilled nursing facility). See Rehab Ex. 17. The financial statements were accompanied by a December 6, 1999 letter written by Western's accounting firm, R.W. Andrews & Co., which stated in part:
Rehab Ex. 17, at 28. Based on a review of Western's financial statements, Mr. McVicker, an auditor with a degree in accounting, testified that Western had three assets that could be liquidated to pay the CMPs. These assets included a $195,000 investment in "collectibles," an investment in land valued at approximately $128,000, and a note receivable from Robert Roy worth $46,872 (Mr. Roy and his wife are Western's sole shareholders). See Tr. at 849-850, 853-860; Rehab Ex. 1, ¶ 2. Mr. McVicker testified that those assets were not used in the day-to-day operations of the two nursing facilities owned by Western and could be liquidated without affecting their ability to carry out those operations. Tr. at 860, 875-876. Mr. McVicker admitted that he could not determine the nature of Western's investment in "collectibles" because Western had elected to omit substantially all of the disclosures required by generally accepted accounting principles (GAAP). Tr. at 852-53, 877; Rehab Ex. 17, at 27. He also explained that the financial statements were not based on an actual examination of Western's books but merely on a compilation of information provided to Western's accountants. Tr. at 852-853, 878. He further indicated that Western's accounting firm, in its December 6, 1999 letter, did not certify the correctness of Western's financial statements but merely presented a picture of Western's financial condition based on the information it had received from the corporation. Tr. at 879. For its part, Rehab submitted no evidence or testimony to contradict Mr. McVicker's testimony or to undermine his conclusions. In its submissions to us, Rehab argued that Western's tax return for the year ended July 31, 1999 (Rehab Ex. 17) was sufficient evidence of its inability to pay the CMP. Reply Brief at 14. On this return, Western reported a net loss for tax purposes of $413,398. See Tr. at 846-47. However, Rehab did not explain why or how the existence of a tax loss would prevent Western from liquidating the assets identified by Mr. McVicker, prevent the company from meeting its current or long-term financial obligations, or otherwise compromise its ability to serve residents and safeguard their health and safety. Rehab also contended that there was, in effect, no basis for any of Mr. McVicker's testimony because Mr. McVicker found Western's financial statements to be incomplete and did not rely on the information in Western's tax returns. Reply Brief at 13. Consequently, said Rehab, "[t]here is no basis whatsoever for any of Mr. McVicker's allegations that assets could be liquidated, let alone for a certain dollar amount." Id. This contention borders on the frivolous. Mr. McVicker's testimony reflected his professional judgment of Rehab's capacity to pay the CMP based on an examination of the unaudited financial statements and other material in the record. Rehab submitted no evidence to impugn that judgment. Even if there were "no basis" for Mr. McVicker's testimony, our conclusions would not change precisely because the financial statements submitted by Rehab were, as it admitted, incomplete or lacking the disclosures necessary to verify their accuracy. The burden in this proceeding is not on CMS to prove Rehab's ability to pay the CMP but on Rehab to present evidence that the CMP would render it insolvent or adversely affect its ability to provide its residents with quality care. See Windsor Health Care Center, DAB No. 1902 (2003)("The key factor in assessing financial condition is whether the facility has adequate assets to pay the CMP without having to go out of business or compromise resident health and safety); 59 Fed. Reg. 56,116, 56,204 (Nov. 10, 1994)("it is the responsibility of the facility to furnish the information it believes appropriately represents its financial status"). Rehab had access to the best evidence -- in particular, testimony by Mr. Roy or Western's financial officer explaining the nature of the assets reflected in the financial statements and identifying material information not disclosed to its accountant -- concerning Western's true financial condition. Rehab chose not to present that evidence but instead allowed the picture of its financial condition to remain cloudy. Under the circumstances, we conclude that Rehab did not establish that its financial condition warranted a reduction in the CMP. The last regulatory factor that merits consideration is Rehab's alleged history of noncompliance, including "repeated deficiencies." "Repeated deficiencies are deficiencies in the same regulatory grouping of requirements found at the last survey, subsequently corrected, and found again at the next survey." 42 C.F.R. § 488.438(d)(3). In asserting that Rehab had a "discreditable" history of noncompliance, CMS pointed to documentation of complaints lodged with state regulators and their designation of the facility as a "focused enforcement facility." Response Brief at 37-38. In particular, information obtained from California's "ACLAIMS" database shows that between September 1997 and August 19, 1998, there were at least 12 substantiated complaints regarding patient care and services lodged against Rehab. See Tr. at 912-913; CMS Ex. 90, at 4-6. In some instances, the substantiated complaints resulted in the issuance of a citation for a class B violation, and the imposition of an appropriate fine, pursuant to the California Health and Safety Code. See Tr. at 896, 912-914; CMS Ex. 90. However, from the evidence before us, we could not determine whether any of the substantiated complaints were for violations of federal participation requirements. Likewise, it is unclear whether Rehab's designation as a "focused enforcement facility" depended on a history of violating federal standards. This is significant because the term "noncompliance" in section 42 C.F.R. § 488.438(f) means a failure to comply with federal participation requirements. Ms. Perse admitted on cross-examination that, prior to the November 1998 survey, Rehab had never been subject to a federal CMP or denial of payment for new admissions, and had never been accused of rendering "substandard care." Tr. at 912-914. CMS produced a record of the 1997 standard survey of Rehab (the one immediately preceding the surveys at issue in this case). Rehab's 1997 standard survey found four deficiencies at level B, eight deficiencies at level D, and one deficiency at level E. CMS Ex. 146, at 8. All were presumably corrected after the survey. At least seven of those deficiencies -- failure to provide a safe, clean, homelike environment (tag F252, level D), failure to provide pharmaceutical services (tag F426, level B), improper labeling of drugs and biologicals (F431, level B), failure to keep drugs in locked compartments (tag F432, level B), failure to maintain an effective pest control program (F469, level B), and failure to obtain laboratory services to meet the needs of residents (F502, level D) -- are part of the same regulatory grouping of deficiencies cited during the surveys at issue in this case. Consequently, there is some basis for finding that Rehab had "repeated deficiencies" within the meaning of the regulations. CMS asserted that Rehab's history of noncompliance was a factor that "weighs heavily in favor of a relatively high CMP level." Response Brief at 37. Because the record shows that Rehab had some repeated deficiencies, we give some weight to this factor. However, we accord it less weight than CMS (and the ALJ) apparently did, given that CMS's reliance on the designation of Rehab as a focused enforcement facility, rather than on an analysis of Rehab's history in meeting federal participation requirements, was unwarranted. Rehab suggested that its compliance history was actually a good one and that its history of compliance is a factor that justifies a penalty lower than the one imposed by CMS. See RR at 10. Even if we were to find that Rehab had a "good" or outstanding compliance history, we could not consider that circumstance in assessing the reasonableness of the CMP. Section 488.438(e)(3) precludes the consideration of factors not listed in (or incorporated by) section 488.438(f) in reviewing the amount of the CMP. The Board has held that although a "history of noncompliance" is one of the factors to be considered, the absence of a history of noncompliance is not a mitigating factor. Franklin Care Center, DAB No. 1900 (2003). In a more general vein, Rehab contended that the CMPs are excessive when compared with CMPs imposed for comparable violations in other cases. RR at 22-23. We find no merit to this contention. Case-to-case comparisons generally have little value given the unique circumstances of each case and the myriad factors that must be considered. See Pacific Regency Arvin, DAB No. 1823, at 17 (2002)("determining a reasonable CMP amount is not dictated by any simple numerical formula but rather requires a consideration of and interaction among a number of factors which are specified in the regulations"). In any event, Rehab made little, if any, effort to show that the cases it cited are comparable to its own in material respects. Our review of the cases cited by Rehab does not alone persuade us that the penalties imposed by CMS were beyond the realm of reasonableness given the number, nature, and seriousness of the deficiencies found in this case. It bears repeating that the purpose of a CMP is to encourage a facility to bring itself into prompt compliance with Medicare's requirements to ensure that resident health and safety is not compromised. See 59 Fed. Reg. 56,116, 56,128-56,129 (Nov. 10, 1994). Rehab remained out of compliance for approximately three months after the initial (November 1998) survey, and it offered no credible explanation for its delay. If anything, these circumstances suggest that the penalty imposed by CMS -- $2,500 per day -- was insufficient to bring about prompt compliance. See Milpitas Care Center, DAB No. 1864 (2003)("Clearly, Milpitas's response to the initial CMP [that is, its failure to correct deficiencies] does not suggest that less pressure was necessary"). Nevertheless, in light of our findings and conclusions in section C above (including some in favor of Rehab), the ALJ's findings and conclusions that we affirm, and the regulatory factors discussed above, we conclude that the CMP of $2,500 was not within a reasonable range, and that $2,300 per day is a reasonable amount for the period November 7, 1998 through February 7, 1999. Conclusion For the reasons stated above, we sustain the CMP of $8,000 imposed in this case for the immediate jeopardy period, but reduce the CMP imposed for the remaining period from $2,500 per day to $2,300 per day. |
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Cecilia Sparks Ford Donald F. Garrett Judith A. Ballard |
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1. CMS issued a penalty notice regarding the January survey in May 1999. Rehab Ex. 26. The DPNA was in effect from February 5 through February 7, contrary to what the ALJ Decision implied. See CMS Exs. 140, 141, and 167. Rehab did not argue to us that the ALJ should have reversed the DPNA, and we conclude that it was properly imposed. 2. The factors Rehab identified as relevant to Resident 11's mental state were her "cognitive loss," use of psychotropic medication, memory problems, and inability to understand others or to make herself understood. See RR at 27-28. Rehab made no attempt to discuss how these factors actually interfered with Resident 11's decision-making or affected the voluntariness of her conduct. 3. In Cedar View Good Samaritan, DAB No. 1897 (2003)(Cedar View), we considered an ALJ's conclusion that a "facility is deficient under 42 C.F.R. § 483.13(b) if it knows or should know that a potentially abusive event may occur and it does not take reasonably necessary steps to prevent it from happening." The Board noted that this conclusion appeared to be consistent with the Board's decision in Beverly, but did not expressly adopt it. Cedar View, at 16, n.6. Here, our holding is framed somewhat differently, to refer both to the potential for injury and to the fact that the injurious behavior appears to be abusive, even if there is some question whether it is "willful". 4. Rehab's core duty to protect residents from harm would not change even if Resident 11's conduct did not, in fact, constitute a "willful infliction of injury." To the extent that Rehab regarded Resident 11's harmful interactions with other residents as "accidents," Rehab had a duty under section 483.25(h)(2) to provide adequate supervision to prevent more accidents. While CMS did not cite this provision as a basis for noncompliance, and we do not rely on it as such, this provision and the regulations as a whole support our conclusion that Rehab could not reasonably think it had no duty to take steps to prevent Resident 11 from harming other residents. 5. Rehab also suggested that CMS set the $2,500 CMP without conducting an independent review of the allegations in the survey documents. See, e.g., RR at 25. We reject this contention for the same reason that we reject Rehab's contention that CMS engaged in a flawed remedy selection process. Cf. Beechwood Sanitarium, DAB No. 1906 (2004)(rejecting a facility's request that deficiency findings be set aside because CMS's decision to impose penalties was based on "unreviewed recommendations" of the state survey agency). 6. The ALJ said that he made no findings on the alleged deficiencies he did not discuss. ALJ Decision at 7. 7. The materiality issue raised by Rehab was not squarely before the Board in Beechwood, a termination and DPNA case. Beechwood did not involve an issue regarding the amount of a CMP. Moreover, the facility in Beechwood did not argue that the ALJ's findings were not a sufficient basis to uphold the remedies imposed, but instead asserted that complete resolution of all disputed deficiencies was necessary because (1) CMS had relied on all of the deficiencies in imposing the remedies; (2) the regulations provided the facility with a right to a hearing on all of the deficiencies found by CMS; and (3) the ALJ Decision was subject to review by the Board and the federal district court and could be reversed by either of them. The Board rejected these arguments, stating that "[t]he possibility of reversal of the deficiency findings on review . . . does not persuade us that the ALJ should be required to make more findings than is necessary to support the remedies imposed." In that context, the Board indicated that the ALJ had discretion regarding whether to address more deficiencies than necessary. 8. During the November survey, findings of noncompliance at level D or higher were made under 25 tags. The ALJ made findings under only 4 tags. For the December survey, the ALJ addressed only 5 of the 12 tags cited at level D or higher. For the January survey, the ALJ addressed only 2 of the 8 tags cited at level D or higher. Three unaddressed deficiencies (cited under tags F242, F314, and F316) were found by the survey agency to have resulted in isolated actual harm. A fourth set of unaddressed deficiencies (cited under tag F309) was found in successive surveys to have caused a "pattern" of actual harm to residents. 9. Thus, we do not agree with Rehab's suggestion (see RR at 20) that a CMP is per se unreasonable "[w]hen the number, scope and severity of the deficiencies that are upheld is substantially less than alleged[.]" 10. That the ALJ sought to limit how many deficiencies he would address is understandable given the number of alleged deficiencies and the large volume of material. The ALJ's task was especially difficult because Rehab's arguments were generally terse and conclusory and often failed to explain fully why Rehab thought the medical documentation supported a finding in its favor under the relevant regulations. 11. The orders were for Risperdal to be administered twice daily ("b.i.d."), and Buspar to be administered once a day. SeeCMS Ex. 150, at 2, 5. 12. Surveyor Valencia testified that cellulitis is a "skin wound type of infection" that "is rather severe, especially in the aging." Tr. at 674. 13. When asked if the staff was physically rough with her, Resident 1 told Surveyor Valencia that "when they try to put me back to bed when I don't want to go -- they hold me down tight." Tr. at 52. 14. CMS promulgated section 483.20(e) in 1989. 54 Fed. Reg. 5316, 5365 (Feb. 2, 1989). Rehab did not allege that it was unaware of the longstanding requirements in that regulation. Nor did it contend that the re-designation altered its understanding of those requirements. 15. The 1997 final rule that re-designated section 483.20(e) as 483.20(l) also moved the list of cross-referenced items from paragraph (b)(2) to paragraph (b)(1) of 483.20. See 57 Fed. Reg. 61,614, 61,615, 61,617 (December 28, 1992); 62 Fed. Reg. 67,174, 67,211 (December 23, 1997). However, the 1997 final rule did not amend the new 483.20(l) to reflect that change. 16. The regulations elsewhere expressly require a facility to provide services that meet professional standards of quality. See 42 C.F.R. § 483.20(k)(3)(i). Thus, a facility could not reasonably interpret the requirement at section 483.25 as being satisfied if the services provided do not meet such standards. 17. The log indicates that the nursing staff was to "[i]rrigate suprapubic tube w/50cc. NS [normal saline] for leaking or plugging PRN." Rehab Ex. 57, at 4. 18. Rehab's citations were to Surveyor Mattern's description of the tests and their general purpose (Tr. at 160-161), and to an Admission and Discharge Record (Rehab Ex. 53, at 1), which listed the resident's diagnoses but mentioned no physician orders and contained no information about the tests. 19. Rehab contended that "any testimony to bolster [the] allegation [that Resident 2 was uncomfortable in the wheelchair] is irrelevant, unduly prejudicial, and lacks adequate notice to the provider" because the allegation was not made in the SOD. Rehab PHB at 48. However, we find no basis to disregard such testimony. The SOD for the November survey did note that Resident 2 was uncomfortable in his wheelchair. CMS Ex. 2, at 29. 20. The record indicates that Surveyor Valencia prompted Rehab to follow up on the original order for the stool sample. Tr. at 525. In response, the physician discontinued the order. Rehab Ex. 64, at 3. The only reason indicated for this change was that the staff was "unable to obtain specimen." Id. 21. Implicit again in Rehab's contentions is the unstated assumption, which we have rejected, that section 483.25 merely requires a facility to implement instructions in the plan of care. 22. There was, in fact, no evidence that Rehab contacted Resident 4's physician prior to the survey concerning the lack of healing. See CMS Ex. 142, at 12. 23. There was evidence that Rehab evaluated the wrist splint to ensure a proper fit, but this evaluation did not occur until after the surveyor called the problem to Rehab's attention. SeeTr. at 757-759. A January 6, 1999 nursing progress note (CMS Ex. 154, at 10) indicates that the sore was "healing" without signs or symptoms of infection, but it is unclear how much healing had actually occurred (no comparisons were made to prior assessments), and there is no indication that the nurse endeavored to determine whether the splint was impairing the healing process. 24. The severity of a pressure sore is designated by a stage number, from I (least severe) to IV (most severe). 25. Paul Wood, a nurse supposedly familiar with Resident 11's care, told Surveyor Valencia that Resident 11 could be resistant to care and positioning. Tr. at 85. However, Surveyor Valencia found nothing in Resident 11's plan of care or comprehensive assessment indicating that he had refused care or had refused to be repositioned. Tr. at 85-86. In its post-hearing brief, Rehab essentially denied that Resident 11 was resistant to care. Rehab PHB at 28. 26. Rehab noted that the monthly treatment records showed only a May 1998 order to "put cotton ball between 4th + 5th toe on [right] foot [until] healed." Rehab Ex. 63, at 1. 27. We note, also, that, contrary to what the surveyor found, there was some evidence in the record that Resident 12 could be uncooperative. See, e.g., Rehab Ex. 53, at 23, 25. 28. These records also show that Rehab provided the necessary skin care to Resident 12 when he was unable to stay dry. CMS Ex. 53, at 13, 20, 22, 24. 29. The term "parenteral" means by injection through some route (subcutaneous, intravenous, intramuscular, etc.) other than the alimentary canal. Dorland's Medical Dictionary (28thedition). 30. Rehab suggested that the nurse observed by Surveyor Mattern on January 13, 1999 was not one of its employees but instead was an employee of the firm that had been hired to administer IV medication. Rehab PHB at 65. However, Rehab did not explain how the nurse's employment status absolves it of responsibility for ensuring that its care of Resident 7 complied with section 483.25(k)(2). Nor did Rehab rebut Surveyor Mattern's testimony that the nurse, whatever her status, did not follow the facility's protocol in flushing the catheter. Tr. at 794. Rehab also pointed to an admission by Surveyor Mattern that there is more than one acceptable way to flush a Groshong catheter. Id. However, this admission does not undermine CMS's case because Rehab offered no evidence that the procedure actually used on Resident 7 was proper and otherwise consistent with accepted standards of nursing practice. 31. Rehab asserted that Mr. Martin's testimony that the nursing director had admitted a significant medication error should not be considered because it was "irrelevant" and "unduly prejudicial" and because Rehab did not have prior notice of the nursing director's statement. Rehab PHB at 34. We do not address this contention because we do not rely on this part of Mr. Martin's testimony to support our conclusion that Rehab was not in substantial compliance with section 483.25(m)(2). 32. In its post-hearing brief, Rehab pointed to no evidence of a history of medication refusals by Resident 8. See Rehab PHB at 33. 33. Regarding the potential for harm, Dr. DeMartini stated: "You want to maintain adequate, steady state plasma levels with the particular medication so that the individual can receive the beneficial effect. This medication is dosed once a day, which means it has a long half life, so in essence by missing three days they had almost a ten percent non-compliance in the drug therapy prescribed by the physician. That can result in therapeutic failure, a worsening of the individual's cognitive status or actually a worsening of the maintenance of the cognitive status." Tr. at 431-432. 34. The available evidence seems to contradict Rehab's assertion. For example, nursing notes show that, on October 27, 1998, Resident 5's blood sugar level was 271. His blood sugar the following morning was still high, at 271. Id. 35. On direct examination, Dr. DeMartini mistakenly assumed that the substance in question was Citracil, not Citracal. SeeTr. at 437-438. (Citracil is a bulk laxative or fiber supplement. Tr. at 469.) She acknowledged this mistake on redirect examination. Tr. at 467-470. 36. Contact isolation requires, among other things, that a resident be placed alone in a private room or in a room with another patient with the same infection. Tr. at 316. 37. Surveyor Mattern testified that there were two typographical errors in two of the five findings related to in-service training. Tr. at 599-600. Rehab suggested that because of these errors, it lacked notice that its in-service training was inadequate. Rehab PHB at 56. However, Surveyor Mattern testified that Rehab had actual notice of these inadequacies because the survey team verbally advised Rehab about them during the survey. Tr. at 639-640. Rehab offered no evidence to rebut this account. Rehab also suggested that the in-service training was adequate because the state survey agency had approved its plan of correction. Rehab PHB at 56. However, this suggestion is misplaced because the inadequacies identified in the SOD related to the plan's implementation, not to its content. 38. The failure to properly flush Resident 7's Groshong catheter was the basis for the deficiency finding under Tag F328. See section C.11., above. In support of that finding, Surveyor Mattern testified that on January 13, 1999, she observed a nurse flushing Resident 7's Groshong catheter in a manner that failed to conform with the established protocol. See Tr. at 760. Surveyor Mattern testified that she was unsure about whether the nurse she observed on January 13 was an Option Care nurse or a Rehab employee. Tr. at 789. Rehab suggested that similar uncertainty existed about the employment status of the nurses who changed the Groshong catheter on January 1 or January 7. Rehab PHB at 67. However, Rehab did not contradict or rebut Surveyor Mattern's testimony that these other nurses were Option Care employees. See Tr. at 789. 39. Indeed, outside of the testimony concerning tag F501, we could find no mention of the medical director anywhere in the 935-page hearing transcript. 40. We need do not here prescribe or fully catalog the circumstances that might warrant a finding of noncompliance with section 483.75(i)(2). However, we note that a violation might occur when the medical director fails (despite notice) to become involved in treatment matters that -- by legal mandate, professional standards, or facility policy -- called for his or her attention. A violation might also occur when the medical director fails to create, implement, enforce, or follow reporting and other policies designed to ensure his or her involvement in the coordination and oversight of resident care at the facility. 41. The scope of a deficiency is "widespread" when "the problems causing the deficiencies are pervasive in the facility and/or represent systemic failure that affected or has the potential to affect a large portion or all of the facility's residents." SOM, Appendix P, sec. V, ¶ C. 42. For the reasons explained below in the discussion of the $2,500 per day CMP, we find no reason to reduce the $8,000 per day CMP based on the other relevant regulatory factors, such as Rehab's financial condition. 43. During the November survey, deficiencies cited under data tags F309, F333, F406, and F426 were found by CMS to constitute "patterns" of noncompliance. During the December survey, patterns of noncompliance were found under tags F309 and F469. During the January survey, patterns of noncompliance were found under tags F157 and F223. According the SOM, a "pattern" of noncompliance exists "when more than a very limited number of residents are affected, and/or more than a very limited number of staff are involved, and/or the situation has occurred in several locations, and/or the same resident(s) have been affected by repeated occurrences of the same deficient practice." SOM App. P, sec. V. 44. The regulations provide for review of the factual basis for a finding of noncompliance on which a proposed remedy is based, but they limit the facility's right to attack the level of noncompliance (that is, the scope and severity). Section 498.3(b)(14) provides that CMS's determination regarding the level of noncompliance may be appealed only if a successful challenge to the determination would alter the range in which the CMP was imposed. See Koester Pavilion, DAB No. 1750, at 8 (2000); Beechwood Sanitarium, DAB No. 1906 (2004). However, as we said in Lake City Extended Care Center, DAB No. 1658, at 13 n. 16., we "see nothing in the regulations that precludes the ALJ from making a new finding as to the scope of a deficiency where the ALJ findings are different from the survey findings." In that situation, an ALJ is not reviewing CMS's determination about the level of noncompliance evidenced by a particular set of facts, but evaluating a materially different set of facts in light of the scope definitions. Here, however, the facts as we find them are not materially different from the facts found by CMS. 45. A facility is culpable if noncompliance causing harm or placing a resident at risk of harm is intentional or is a product of neglect, indifference, or disregard. 42 C.F.R. § 488.438(f)(4); SOM § 7516(B)(5). 46. Mr. McVicker noted that Rehab's tax loss did not reflect the facility's cash flow, which was positive in both 1998 ($6,151) and 1999 ($36,094). Tr. at 847-848. Mr. McVicker also identified certain transactions that cried out for explanation (which Rehab did not provide). According to McVicker, Western spent $38,293 in 1999 to increase its investment in "collectibles," the nature of which was not disclosed. Tr. at 848-850. Also in that year, Western declared a $44,000 dividend in favor of Mr. Roy, even though there were no retained earnings out of which to pay the dividend. Tr. at 857-60. The dividend was apparently used to reduce the balance on the note given by Mr. Roy to the corporation. Tr. at 857. 47. As we explained in Batavia, DAB No. 1904, at 61 n.55, this definition was inadvertently deleted from the regulations in 1999 but later restored. 48. "Substandard quality of care" is a term of art in the nursing home compliance regulations. It means one or more deficiencies related to the participation requirements in 42 C.F.R. §§ 483.13, 483.15, 483.25 that constitute either (1) immediate jeopardy, (2) a "pattern of or widespread actual harm that is not immediate jeopardy," or (3) "a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm." 42 C.F.R. § 488.301. | |||||||||||||||||||||