SUBJECT: Northeastern Ohio Alzheimer's Research Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

On December 2, 2003, the Centers for Medicare & Medicaid Services (CMS) appealed a September 30, 2003 decision by Administrative Law Judge (ALJ) Keith W. Sickendick. Northeastern Ohio Alzheimer's Research Center, DAB CR1092 (2003) (ALJ Decision). The ALJ Decision set aside a $2,400 per instance civil money penalty (CMP) imposed by CMS on Northeastern Ohio Alzheimer's Research Center (NOARC) for its alleged failure to comply with Medicare participation requirements. Because the ALJ Decision is based on errors of law, and because we conclude that NOARC was not in substantial compliance with the regulation that requires a skilled nursing facility to provide its residents with adequate supervision and assistance devices to prevent accidents, we reverse the ALJ Decision and reinstate the CMP. We also conclude that the amount of the CMP imposed by CMS is reasonable.

Regulatory Background

NOARC is a skilled nursing facility (SNF) that participates in the Medicare program. Medicare's participation requirements for SNFs and other long-term care facilities are set forth in 42 C.F.R. Part 483. 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.

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).

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 when it has a deficiency that creates at least the "potential for more than minimal harm." See 42 C.F.R. §§ 488.301 (definition of substantial compliance).

The regulations authorize CMS to impose various remedies, including civil money penalties (CMPs), to encourage facilities to correct deficiencies promptly. CMS selects a remedy based on the survey agency's determination of the seriousness of the facility's noncompliance and other relevant factors. See 42 C.F.R. §§ 488.404, 488.406 and 488.408. (The term "noncompliance" is defined in section 488.301 of the regulations to mean "any deficiency that causes a facility to not be in substantial compliance.")

If CMS decides to impose a CMP, it may impose the penalty for either the number of days the facility is not in substantial compliance (a per day CMP), or "for each instance that [the] facility is not in substantial compliance" (a per instance CMP). 42 C.F.R. § 488.430(a). A per instance CMP must be in the range from $1,000 to $10,000 per instance. 42 C.F.R. § 488.438(a)(2).

Case Background

The following background information is drawn mostly from the ALJ Decision and is undisputed. ⁽¹⁾ On February 10, 2000, the Ohio Department of Health (ODH) completed a standard survey and a Life Safety Code survey of NOARC. As a result of these surveys, ODH cited NOARC for deficiencies under two tags: F324 and K020. See CMS Exs. 2-3.

An incident involving Resident 3 was the basis for the deficiency finding under tag F324. On February 6, 2000, Resident 3 was walking in a hallway with the help of Nurse Aide Norman Sommers. While helping Resident 3 to walk, Mr. Sommers heard a bed alarm sounding in a nearby room. Believing that the resident who triggered the alarm, Resident D.B., might fall from his bed, Mr. Sommers left Resident 3 standing in the hallway holding a handrail and went to Resident D.B.'s room. Mr. Sommers shut off the alarm, repositioned Resident D.B. in his bed, and returned to the hallway, where he found Resident 3 lying on her left side on the floor. An x-ray taken later that day revealed that Resident 3 had fractured her left hip joint. Based in part on these facts, ODH determined that NOARC was not in substantial compliance with 42 C.F.R. § 483.25(h)(2), which requires a facility to ensure that each resident "receives adequate supervision and assistance devices to prevent accidents." See CMS Ex. 6.

The deficiency finding under tag K020 stemmed from the Life Safety Code survey. During that survey, ODH found that NOARC was not compliant with the 1981 Life Safety Code because certain doors that enclosed two stairwells in the "rest home" portion of the facility would not latch or close securely. Based on that finding, ODH determined that NOARC was not in substantial compliance with 42 C.F.R. § 483.70(a), which provides that a facility must meet applicable Life Safety Code standards. See CMS Ex. 3, at 2.

On March 10, 2000, CMS issued a Notice of Imposition of Remedy. CMS Ex. 6. The notice advised NOARC that it was not in substantial compliance with Medicare and Medicaid participation requirements, and that a $2,400 per instance CMP would be imposed for its noncompliance. The notice also indicated that a denial of payment for new admissions (DPNA) would be imposed if the facility did not attain substantial compliance by May 10, 2000.

On March 23, 2000, ODH conducted a revisit survey and determined that NOARC had come back into substantial compliance. See CMS Ex. 7. On May 1, 2000, CMS notified NOARC by letter that the DPNA would not take effect because the facility had attained substantial compliance but that a $2,400 CMP was due and payable. CMS Ex. 9.

NOARC appealed the CMP by requesting an ALJ hearing. CMS responded with a motion for summary judgment, which the ALJ denied. On July 16, 2002, the ALJ conducted an evidentiary hearing, during which the parties presented testimony concerning both alleged deficiencies.

ALJ Decision

Regarding the alleged deficiency involving Resident 3 (cited under tag F324), the ALJ made the following finding:

CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2) in this case because it has been shown that Petitioner's staff knew that Resident 3 required at least a one person assist when ambulating in the halls, that she had difficulty balancing without some physical assistance while standing, that she had poor judgment and safety awareness and required supervision, [and] that she was unable to understand or make herself understood; nevertheless, Petitioner's employee [nurse aide Norman Sommers] left Resident 3 standing in the hall and she fell and was injured.

ALJ Decision at 6. Although he found that CMS had shown a violation of section 483.25(h)(2), the ALJ declined to uphold the CMP based on that violation. Id. Applying the defense of "necessity," the ALJ decided that NOARC's violation was "excused" because Mr. Sommers had acted reasonably when he left Resident 3 in the hallway in order to help Resident D.B. Id. at 6, 17. According to the ALJ, Mr. Sommers acted reasonably "because he was confronted with the situation where either of two residents might be injured by his action or inaction, and whether deliberately or not, he effectively calculated that there was less risk for harm to Resident 3 and chose to act to save the other resident." Id. at 18. The ALJ added:

I would not characterize Mr. Sommers judgment as poor, he simply made a choice that neither his employer nor CMS, with the benefit of hindsight, agreed with. Mr. Sommers reasonably believed it necessary for him to prevent injury to the resident who triggered the alarm and he reasonably believed the likelihood of harm to Resident 3 was less than to the other resident.

Id.

The ALJ also addressed the deficiency cited under tag K020. In particular, he found that CMS had failed to establish that NOARC was not in substantial compliance with section 483.70(a) because, when the Life Safety Code survey was conducted, section 483.70(a) incorporated only the 1985 edition of the Life Safety Code, not the 1981 edition applied by the survey agency. ALJ Decision at 18-23. The ALJ found that, because CMS was seeking to enforce the Life Safety Code as a regulation, CMS was obligated to show either that the 1981 edition had been published in the regulations or properly incorporated by reference, or that NOARC had received timely and actual notice of the 1981 edition's contents. Id. at 22-23. CMS made neither showing, the ALJ found. Id.

Based on the foregoing findings and conclusions, the ALJ determined that there were no legal or factual grounds supporting the imposition of a CMP or other remedy against NOARC. Accordingly, he set aside the $2,400 per instance CMP imposed by CMS.

Standard of Review

The standard for our review of an ALJ decision on a disputed issue 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. Guidelines - Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (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, CMS contended that use of the defense of necessity to preclude the imposition of a remedy for the facility's alleged noncompliance with section 483.25(h)(2) is an error of law. Request for Review (RR) at 18-22. NOARC responded that the defense "fits wholly within the contemporary decisions of the Departmental Appeals Board," though it offered no significant argument to buttress that assertion. See Response Brief at 10. NOARC instead focused on showing that CMS had failed to make a prima facie showing of noncompliance with section 483.25(h)(2). Id. at 3-10.

Regarding the deficiency alleged under tag K020, CMS argued that the ALJ should have refrained from making any legal conclusions concerning the enforceability of the 1981 Life Safety Code because that issue had not been raised beforehand by the parties or by the ALJ. RR at 30-31. CMS also argued that the ALJ's conclusions were wrong on the merits because prior editions of the regulations had expressly incorporated the 1981 Life Safety Code, and that this incorporation had been effectively preserved in the regulations that were in effect when the survey occurred. Id. at 31-33. CMS also contended that NOARC had actual notice of the relevant provisions of the 1981 Life Safety Code because they are identical to those contained in the 1985 Life Safety Code, which section 483.70(a)(1) incorporated by reference at the time of the survey. Id. at 33. NOARC did not respond to or rebut these arguments. Instead, NOARC contended that the evidence submitted by CMS concerning the condition of the rest home's stairwell doors failed to establish a violation of the Life Safety Code. Response Brief at 11-15.

As explained in section A below, we agree with CMS that the defense of necessity may not be invoked in these enforcement proceedings to bar the imposition of a CMP (or other remedy) for noncompliance with a participation requirement. The circumstances relevant to this defense may, however, be relevant in evaluating whether the facility was in substantial compliance. We therefore consider these circumstances in addressing whether NOARC was in substantial compliance with section 483.25(h)(2) in its care of Resident 3. ⁽²⁾ Regarding that issue we make de novo findings of fact and conclusions of law in section B. ⁽³⁾ In section C, we set aside, on jurisdictional grounds, the ALJ's findings of fact and conclusions of law regarding the alleged Life Safety Code deficiency (under tag K020). Finally, in section D, we find that the $2,400 CMP, which CMS imposed for NOARC's noncompliance with section 483.25(h)(2), is reasonable in amount.

Our findings and conclusions are based on the record that was before the ALJ. Regarding the incident involving Resident 3, CMS presented the testimony of Ruth Allen, R.N., the surveyor whose observations and findings are reflected in the SOD under tag F324. NOARC called three witnesses on this subject, all facility employees: Jane Richter, L.P.N.; Robin Prince, NOARC's director of nursing; and Mr. Sommers. The testimony of these four witnesses concerning the underlying facts was not in conflict, was consistent with the documentary record, and was accurately summarized by the ALJ (see ALJ Decision at 13-15). We therefore adopt and incorporate the findings of fact in section II.A., ¶¶ 1-13 of the ALJ Decision.

A. The defense of necessity is unavailable in nursing home enforcement proceedings brought under 42 C.F.R. Part 488, subpart F.

The defense of necessity is a common law doctrine, applied most frequently in the criminal law, under which an actor may be absolved of legal responsibility for a statutory or regulatory violation if forces beyond the actor's control rendered his illegal conduct the lesser of two evils. See Model Penal Code § 3.02. Common law defenses, however, are inapplicable in these administrative proceedings because the Medicare participation requirements in 42 C.F.R. subpart A (42 C.F.R. §§ 483.1 et seq.) "can and do set a higher standard than the common law." Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003) ⁽⁴⁾; see also Madison Health Care, Inc., DAB No. 1927, at 8 (2004) (rejecting a contention that common law negligence standards define a facility's duties under section 483.25(h)(2) and noting that, "[w]hile useful reference may sometimes be made to common-law concepts," federal law, not common law negligence standards, governs the facility's obligations).

In addition, application of the necessity defense is inconsistent with the enforcement scheme in 42 C.F.R. Part 488, subpart F, which authorizes CMS to impose remedies "in addition to any others available under State or Federal law." 42 C.F.R. § 488.400. In fact, the defense could, in some circumstances, serve to negate regulatory provisions that require CMS to impose a remedy for a facility's noncompliance. See 42 C.F.R. § 488.410 (a)(4) (requiring CMS to terminate a provider agreement if immediate jeopardy is not removed within 23 calendar days of the last day of the survey). The preamble to the regulations in subpart F stresses that the nursing home enforcement scheme is "built on the assumption that all [Medicare participation] requirements must be met and enforced," and that the goal of the regulations is "to promote facility compliance by ensuring that all deficient providers are appropriately sanctioned." 59 Fed. Reg. 56,116, 56,117 (Nov. 10, 1994). This regulatory goal -- which serves to protect the health, safety, and rights of residents -- is in direct conflict with the idea that a noncompliant facility may avoid a remedy based on a defense that does not negate or remove the factual basis for a finding of noncompliance.

When he left Resident 3 by herself in order to help Resident D.B., Mr. Sommers, the nurse aide, certainly made an unpalatable choice. By treating Mr. Sommers' choice as a defense to the imposition of a remedy, however, the ALJ erroneously assumed that the responsibility for adequately supervising Resident 3 and Resident D.B. rested solely with Mr. Sommers. To the contrary, section 483.25(h)(2) makes the facility ultimately responsible for ensuring the safety of residents through its policies, procedures, staff training and allocation, and other means -- and not merely through the actions taken or choices made by individual employees. In addition, section 483.25(h)(2) requires the facility to provide "each resident" with adequate supervision and assistance devices to prevent accidents. Applying the defense of necessity on the theory that Resident D.B. was in greater danger than Resident 3 would effectively permit the facility to compromise the safety of one resident for the benefit of another and to avoid its responsibility to anticipate, plan for, and meet all residents' needs. This is inconsistent with the regulations, read as a whole.

B. NOARC was not in substantial compliance with section 483.25(h)(2) in its care of Resident 3.

As indicated, section 483.25(h)(2) provides that a facility "must ensure" that "each resident receives adequate supervision and assistance devices to prevent accidents." In Woodstock Care Center, the Board analyzed the wording, context, and history of section 483.25(h)(2) and, based on that analysis, set out a framework for evaluating allegations of noncompliance with that requirement. Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). We determined that although section 483.25(h)(2) does not hold a facility strictly liable for accidents that occur, it does require the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents. Id.; see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must be adequate under the circumstances. See Woodstock Care Center. What are adequate supervision and assistance devices for a particular resident depends, of course, on the resident's ability to protect himself from harm. Id.

It is undisputed that on February 6, 2000, Nurse Aide Sommers left Resident 3 alone, standing in the hallway holding a handrail, for as many as two minutes while he responded to a bed alarm in Resident D.B.'s room. Tr. at 130. Resident 3, the record shows, suffered from confusion and dementia. NOARC Ex. 2, at 70. Her comprehensive assessment (dated November 22, 1999) indicates that she had "moderately" impaired decision-making ability, was "easily distracted," and rarely or never understood verbal information from others. NOARC Ex. 2, at 15. Her comprehensive assessment also indicates that she could not perform a "balance while standing" test without physical assistance, that she needed the assistance of one or two persons to ambulate in her room or in the corridor on her unit, and that she had partial loss of voluntary movement in one or both arms, hands, legs and feet. Id. at 16-17. Her plan of care, first prepared in September 1999, states that she was "at risk for falls/injury [due to] unsteady gait & poor safety awareness." Id. at 70. A "falls risk assessment" dated August 31, 1999 states that she had experienced a "general decline in condition," and that her confusion and dementia "[c]auses her to be at risk for falls [due to] coordination problems[.]" Id. at 12.

Jane Richter, a licensed practical nurse, testified that Resident 3 was on a restorative ambulation program in which she walked 300 feet per day with the assistance of one or two persons. Tr. at 116. Robin Prince explained that, at times, Resident 3 needed only a handheld assist, which meant "just taking her by the hand and more or less leading her down the hall." Tr. at 122-123. Both Nurse Richter and Ms. Prince admitted that Resident 3's ability to ambulate varied from day to day: on some days she walked well with one person's help; on others, she needed two persons' help. Tr. at 117, 122.

Ruth Allen, a nurse with experience in training nursing home employees on how to transfer and ambulate patients with mobility problems, testified that it was unacceptable to leave Resident 3 standing alone holding the handrail because of her dementia and poor safety awareness. Tr. at 34, 38, 43-44. Nurse Allen also testified that, had she been in Mr. Sommers' position, she would have either placed Resident 3 with another staff member, seated her in a chair near another staff member, or taken her into Resident D.B.'s room, where a chair could be found. Tr. at 42, 55.

Based on the foregoing facts and evidence, we find that, prior to February 6, 2000, it was foreseeable that Resident 3 might fall or have an accident if she were left -- even for a very short time -- standing by herself holding on to a handrail or other object. Because of her cognitive deficits, poor safety awareness, and inability to understand others, there was substantial risk that she would not follow an instruction to hold the handrail and would instead attempt to stand or ambulate without support. Standing and ambulating were activities that her comprehensive assessment indicated she could not consistently perform without the physical support or close supervision of another person.

The testimony of NOARC's witnesses concerning Resident 3's functional capacity does not establish that the risk of accidental injury was negligible or insubstantial, or that the risk was unforeseeable. Ms. Prince testified that Resident 3 was "capable of standing for a period of time." Tr. at 121. However, she did not indicate how long Resident 3 could stand or specify the basis for her opinion. Ms. Prince also failed to address the finding in the comprehensive assessment that Resident 3 could not perform a standing balance test. In addition, Ms. Prince was not asked to consider the danger presented by Resident 3's cognitive deficits and lack of safety awareness.

As indicated, Ms. Prince testified that Resident 3 could "sometimes" ambulate with just a "handheld assist," meaning that she could ambulate without the weight-bearing support of a nurse aide. Tr. at 122-123. Ms. Prince conceded, though, that Resident 3's functional abilities fluctuated from day to day, and that on some days she needed more than a handheld assist. Id. This testimony suggests that the facility knew that if Resident 3 attempted to walk without assistance, there was a substantial risk that she would fall.

Mr. Sommers testified that he had known Resident 3 for three years and that he helped shower her two or three times a week. Tr. at 131. When asked if he had observed Resident 3 standing unassisted, Mr. Sommers replied:

Yes. Because, when I would give her a shower we could stand her up. She would hold onto the sink while we did personal care on her, got her dressed and everything.

Id. Mr. Sommers also testified that Resident 3 could stand unassisted "for a good minute, minute and a half" without someone assisting her. Id.

At best Mr. Sommers' testimony supports a finding that Resident 3 could stand on her own only if she held on to a sink or other object for support, and even then she could not stand for more than 90 seconds without requiring some assistance. Like Robin Prince, Mr. Sommers did not indicate whether Resident 3 could, if instructed, consistently or reliably hold on to an object (e.g., a sink or handrail) for support, maintain her balance in that position, and refrain from attempting to walk or stand on her own for more than a very short period of time. In addition, Mr. Sommers admitted that he left Resident 3 alone on February 6 for as long as two minutes, an amount of time that exceeded his estimate of her capacity to stand unassisted (90 seconds). See Tr. at 130-131. If anything, Mr. Sommers's testimony about Resident 3's inability to stand for more than a very short period of time supports CMS's assertion that it was unreasonable to leave her standing alone without close supervision. ⁽⁵⁾

Given the foreseeable risk of accidental injury in leaving Resident 3 standing alone unassisted, NOARC was obligated to provide her with an "adequate" level of staff supervision -- that is, a level of supervision reasonably designed to meet her needs and functional capacity (as reflected in the comprehensive assessment and plan of care) and that, together with the use of assistance devices, addressed the foreseeable risk of injury or harm from accidents. Windsor Health Care Center, DAB No. 1902 (2003). Given her poor safety awareness, cognitive impairment, and inability to ambulate or balance without assistance, we find that Resident 3 needed a nurse aide to be available and ready to assist her whenever she was standing or attempting to stand on her own, even with the assistance of a handrail. On February 6, 2000, she did not receive this level of supervision because she was left standing alone by Mr. Sommers for as many as two minutes while he attended to Resident D.B. While helping Resident D.B., Mr. Sommers was in no position to assist Resident 3 in case she lost her balance, became unstable, or attempted to walk or stand without support. We conclude, therefore, that Resident 3 did not receive adequate supervision.

NOARC suggested that the CMS had an obligation to allege and prove that the facility was inadequately staffed to meet Resident 3's needs. Response Brief at 5. We disagree with NOARC's implicit proposition, which is that CMS failed to carry its burden of proof. CMS's burden was to make a prima facie showing of noncompliance with section 483.25(h)(2). See Florence Park Care Center, DAB No. 1931 (2004). All that regulation required was evidence that NOARC failed to ensure that one or more residents received adequate supervision and assistance devices to prevent accidents -- in other words, that the facility failed to take reasonable steps to mitigate a foreseeable risk of harm to a particular resident or residents. Section 483.25(h)(2) did not require CMS to submit proof, as part of its prima facie case, about the possible reasons why a facility failed to provide adequate supervision. ⁽⁶⁾ See Florence Park Care Center at 16-18 (noting that CMS was not required to present evidence of "institutional failures" that led or contributed to the noncompliance).

In this case, CMS carried its evidentiary burden: it submitted evidence that Resident 3 was at substantial risk for accidental injury if she were left standing on her own without supervision, and that the risk was foreseeable. CMS also submitted evidence that, for a short but significant period on February 6, 2002, NOARC's employee left Resident 3 standing alone without the supervision needed to meet her assessed needs. Because CMS made a prima facie showing of noncompliance, the burden shifted to NOARC to show that it was in substantial compliance. See Florence Park Care Center. NOARC did not carry its burden or otherwise adequately justify its failure to supervise Resident 3.

NOARC argued that Resident 3's supervision was adequate under the circumstances because Mr. Sommers was confronted with a "clear emergency situation" involving Resident D.B. NOARC Response at 3-4. We disagree with this contention because we can find no basis in the record or regulations to conclude that Resident D.B.'s emergency necessarily limited the facility's obligation to protect Resident 3. As discussed, section 483.25(h)(2) required the facility to provide both residents with adequate supervision. Having undertaken to care for both residents, NOARC should have foreseen that it needed to have sufficient staff available to respond to Resident D.B.'s bed alarm in the event that a nearby nurse aide, like Mr. Sommers, was assisting another resident whom he could not leave. At the very least, the facility should have trained Mr. Sommers about how to respond in these circumstances and should have instituted procedures or policies to ensure that its nursing staff was deployed in a manner that ensured that bed emergencies would be handled expeditiously without compromising the safety of other residents who might be ambulating in the hallway. NOARC offered no evidence that it had such policies or procedures, or that it had given Mr. Sommers appropriate training. ⁽⁷⁾

According to NOARC, CMS would have penalized the facility regardless of how Mr. Sommers responded to the bed alarm on February 6, 2000. Response Brief at 3. This assertion is speculative at best. The assumption underlying it is that if Mr. Sommers had stayed with Resident 3, Resident D.B. would have suffered an accidental injury and that CMS would have cited the facility for a deficiency on that basis. As the Board has emphasized in prior decisions, however, the occurrence of an accident does not, by itself, prove that a resident received inadequate supervision or assistance devices. See Josephine Sunset Home, DAB No. 1908, at 14 (2004) (citing Woodstock Care Center).

NOARC also asserted that Resident 3 had severe bone demineralization, and that this condition, not her fall on February 6, might have caused her hip fracture. Response Brief at 4. On cross-examination, Surveyor Allen could not rule out the possibility that the fracture had occurred before Resident 3 fell. Tr. at 50. NOARC contended that CMS "needed to prove that the resident's medical condition did not cause the fracture, unless the DAB is prepared to hold that the manifestation of disease related conditions creates liability for a nursing facility[.]" ⁽⁸⁾ Response Brief at 7. We find no merit to this contention because section 483.25(h)(2) contains no requirement that the facility's failure to supervise a resident actually result in, or cause, an accident or injury. See Clermont Nursing and Convalescent Center, DAB No. 1923, at 20-21 (2004). The deficiency is not that the facility failed to prevent Resident 3 from falling, but that it failed to provide her with adequate supervision and assistance devices to prevent accidents. ⁽⁹⁾ Moreover, to establish that a facility was not in substantial compliance, CMS need not show that the deficiency resulted in actual harm to a resident, only that it created the potential for more than minimal harm. See 42 C.F.R. § 488.301 (definition of "substantial compliance").

Based on the testimony and on the other evidence of record, we conclude that CMS made a prima facie showing of noncompliance with section 483.25(h)(2) and that NOARC failed to carry its burden of proving that it was in substantial compliance with that regulation.

C. CMS's determination (under tag K020) that NOARC was not in substantial compliance with section 483.70(a) is not an appealable determination.

The regulations in 42 C.F.R. Part 498 provide appeal rights and procedures for providers dissatisfied with certain determinations by CMS. Under these regulations, the ALJ may review "initial determinations" that CMS makes with respect to the matters specified in section 498.3(b). 42 C.F.R. § 498.3(a). The appealable initial determinations specified in section 498.3(b) include a "finding of noncompliance that results in the imposition of a remedy specified in § 488.406 . . ., except the State monitoring remedy." See 42 C.F.R. § 498.3(b)(13) (emphasis added). As we now explain, the finding of noncompliance under tag K020 did not result in the imposition of a remedy and was therefore not an appealable determination.

After the February 2000 standard survey of NOARC, ODH recommended a "per instance" CMP of $2,400 and other remedies (as indicated, a CMP may be imposed on a per day or per instance basis ⁽¹⁰⁾). ODH informed NOARC of its recommended remedies in a letter which states in relevant part: "Based upon the results of this survey, we are recommending that HCFA impose . . . . [a] per instance civil money penalty in the amount of $2,400, effective February 10, 2000, . . . for the deficiency identified by data tag F324." ⁽¹¹⁾ CMS Ex. 1, at 2 (emphasis added). ODH's letter did not mention the deficiency finding under tag K020. On March 10, 2000, CMS sent NOARC written notice that it had accepted ODH's recommendation and that it was imposing a $2,400 CMP "for an instance" of noncompliance. CMS Ex. 6. The March 10 penalty notice also advised NOARC that CMS would impose a denial of payment for new admissions (DPNA) effective May 10, 2000. Id. On March 23, 2000, ODH conducted a revisit survey and determined that the facility was in substantial compliance. CMS Ex. 7. On May 1, 2000, CMS issued a second penalty notice. CMS Ex. 9. The May 1 notice withdrew the DPNA and stated that CMS was "now proceeding with imposition of the CMP effective February 10, 2000." Id. The May 1 notice specified no other remedies. NOARC's request for hearing was filed in response to the May 1 notice. At the hearing, CMS confirmed that the total CMP due was $2,400. Tr. at 8.

In view of these circumstances, we find that the CMP was imposed for the noncompliance cited under tag F324, not for the alleged Life Safety Code violation cited under tag K020. Although the March 8 and May 1 penalty notices do not specify the "instance" of noncompliance, the context of these notices makes it clear that CMS's decision to impose the CMP was based on the survey agency's recommendation that expressly linked the CMP to NOARC's noncompliance with section 483.25(h)(2). Moreover, it is reasonable to believe that the CMP was imposed for that instance of noncompliance because the survey agency had assigned it a higher level of seriousness (level G) than the Life Safety Code deficiency (level D).

Because no CMP or other remedy was imposed for an instance of noncompliance with section 483.70(a), the finding of noncompliance under tag K020 did not result in a remedy and was therefore not an appealable initial determination within the meaning of section 498.3(b)(13). Accordingly, we vacate the ALJ's findings of fact and conclusions of law concerning the alleged Life Safety Code deficiency. ⁽¹²⁾

D. The amount of the CMP imposed by CMS was reasonable.

Having determined (in section B above) that CMS had adequate grounds to impose a per instance CMP, we must next consider whether the amount of that penalty was reasonable. A determination concerning the reasonableness of the CMP must be guided by the factors specified in (or cross-referenced by) 42 C.F.R. § 488.438(f). See CarePlex of Silver Spring, DAB No. 1683 (1999).

In Coquina Center, DAB No. 1860 (2002), we stated:

[T]here is a presumption that CMS has considered the regulatory factors [in section 488.438(f)] in setting the amount of the CMP and that those factors support the CMP amount imposed by CMS. Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.

Coquina Center, at 32.

CMS contended in its pre- and post-hearing briefs that the per instance CMP of $2,400 was a reasonable amount for the two deficiencies together or for either deficiency standing alone. See CMS Pre-Hearing Brief, at 13; CMS Post-Hearing Brief, at 28. NOARC's pre-hearing and post-hearing briefs contain no response to this contention. CMS reiterated its contention concerning the reasonableness of the CMP in its request for review. RR at 40. NOARC again failed to respond. Because NOARC did not contend before the ALJ or on appeal that the regulatory factors warranted a reduction in the CMP, we have no basis to determine that those factors support a reduction in the amount imposed. Accordingly, we conclude that the amount of the CMP imposed by CMS is reasonable.

Conclusion

For the reasons above, we reverse the conclusions of law in section II.B., ¶¶ 5-6, 18-19 of the ALJ Decision; vacate the findings of fact and conclusions of law regarding the alleged Life Safety Code Deficiency (section II.A., ¶¶ 14-20 and section II.B., ¶¶ 4-5 of the ALJ Decision); and leave undisturbed any other findings or conclusions that are not germane to the issues before us. In addition, we adopt and incorporate the factual findings in section II.A., ¶¶ 1-13 of the ALJ Decision. Finally, we make the following findings and conclusions (which we elaborate on in sections A through D above):

A. The common law defense of necessity may not be applied to bar the imposition of a remedy for a facility's noncompliance with Medicare participation requirements;

B. NOARC was not in substantial compliance with 42 C.F.R. § 483.25(h)(2);

C. CMS's finding that NOARC was not in substantial compliance with 42 C.F.R. § 483.70(a) is not an appealable determination; and

D. The amount of the CMP imposed by CMS for NOARC's noncompliance with 42 C.F.R. § 483.25(h)(2) is reasonable.

Based on these findings, we sustain the $2,400 CMP imposed by CMS.

Cecilia Sparks Ford

Donald F. Garrett

Judith A. Ballard
Presiding Board Member

1. The "Parties' Joint Stipulation of Undisputed Facts" (dated May 31, 2002) contains some of this information as well.

2. The facts that serve to establish the elements of the defense may also be relevant in evaluating the facility's degree of culpability, a factor in assessing whether the amount of the CMP is reasonable. As discussed below in section D, NOARC did not contend that any particular factor warranted a reduction in the CMP.

3. As indicated below, the evidence submitted by the parties is not in conflict, and we therefore adopt as our own the ALJ's factual findings that are based on that evidence. What are in dispute in this appeal are not the facts pertaining to the incident involving Resident 3, but the parties' divergent conclusions about whether those facts show noncompliance with section 483.25(h)(2). We reach the same conclusion that the ALJ apparently did -- that NOARC was not in compliance with 42 C.F.R. § 483.25(h)(2) and further conclude that this deficiency had a potential for more than minimal harm.

4. Citing Sixth Circuit court rule 28(g), NOARC asserted in its response brief that the Board should not rely on the Sixth Circuit's decision in Woodstock because it was not published in the Federal Reporter. NOARC Response at 1. We need not respond to this contention because that decision has since been published (at 363 F.3d 583).

5. Because we conclude that there was a foreseeable and substantial risk that Resident 3 would fall or have an accident under these circumstances, we reject NOARC's contention (Response Brief at 9) that the facility is being held strictly liable for an unforseeable accident.

6. By asserting that CMS should have submitted evidence of inadequate staffing, NOARC implied that inadequate staffing was the only possible explanation for the facility's noncompliance and that the facility had taken all reasonable steps to ensure that Resident 3 was adequately supervised given the level of staffing it had. NOARC made no effort to show why these propositions might be true. Whether a facility succeeds in adequately supervising its residents depends not only on whether it has adequate numbers of employees to meet residents' needs but on other factors, such as whether the facility deploys those employees effectively, has policies and procedures to guide their actions, and provides them with adequate training.

7. As the ALJ found (ALJ Decision at 17), there is no evidence that other facility employees were available to help Mr. Sommers when he heard Resident D.B.'s bed alarm. Robin Prince testified that, when Resident 3 fell (at around 11:30 a.m.), most or all of the facility's residents would have been at, or proceeding to, the dining room, and that a majority of the nursing staff would have been performing tray service at the dining room or helping to feed residents in their rooms. See Tr. at 39, 125. NOARC did not assert in its response brief that these were unforeseeable circumstances that would explain why other employees were unavailable to respond to the bed alarm. If Mr. Sommers was in fact the only person available to respond in a timely fashion to the bed alarm, then one might reasonably question whether Resident D.B. was receiving adequate supervision and assistance devices on February 6, 2000. That Mr. Sommers was nearby when the alarm sounded was undoubtedly a coincidence.

8. In making this argument, NOARC pointed to the State Operations Manual's surveyor guidelines, which state that "adverse outcomes associated as a direct consequence of treatment or care" do not constitute an "accident." State Operations Manual, App. PP (tag F324 Guidelines).

9. CMS's finding that the deficiency resulted in the fracture is, in any event, supported by Surveyor Allen's testimony that it was more likely than not that the fall caused, or was a contributing cause of, Resident 3's hip fracture. Tr. at 50.

10. See 42 C.F.R. § 488.430(a).

11. As indicated, a CMP may be imposed on a "per day" basis or for "each instance that a facility is not in substantial compliance." 42 C.F.R. § 488.430(a).

12. In light of our jurisdictional ruling, CMS's motion to admit new evidence concerning the alleged Life Safety Code deficiency is moot.