SUBJECT: Price Hill Nursing Home,

Petitioner,

Health Care Financing Administration

FINAL DECISION ON REVIEW OF

ADMINISTRATIVE LAW JUDGE DECISION

Price Hill Nursing Home (Price Hill) and the Health Care Financing Administration (HCFA)⁽¹⁾ both appealed the February 23, 2001 decision of Administrative Law Judge Jill S. Clifton upholding HCFA's imposition of a civil monetary penalty (CMP) on Price Hill for the period September 3, 1997 through November 20, 1997 but reducing the amount of the penalty from $66,950 to $6,950. See Price Hill Nursing Home, DAB CR745 (2001) (ALJ Decision). Price Hill excepted to the ALJ's findings that it failed to prove that it was in substantial compliance with several Medicare participation requirements. Price Hill also excepted to the ALJ's findings that Price Hill was not in substantial compliance with one of the participation requirements, the quality of care requirement at 42 C.F.R. � 483.25(h)(2), on September 3, 1997, and that its noncompliance constituted immediate jeopardy. HCFA excepted to the ALJ's finding that Price Hill was in substantial compliance with section 483.25(h)(2) after September 3.

For the reasons explained in detail below, we sustain the ALJ Decision in its entirety and affirm and adopt all of the numbered FFCLs.⁽²⁾

Background

Price Hill is a skilled nursing facility (SNF) in Cincinnati, Ohio that participates in the Medicare program. The Ohio Department of Health conducted surveys of Price Hill from September 23-26, 1997, and on October 3, 1997, in order to determine Price Hill's compliance with the statutory and regulatory requirements of participation imposed on all SNFs.⁽³⁾ Based on those surveys, HCFA found that Price Hill was not in substantial compliance with several Medicare participation requirements, including the following:
o Section 483.25(h)(2), requiring that the facility ensure that each resident receives adequate supervision and assistance devices to prevent accidents;
o Section 483.25(h)(1), requiring that the facility ensure that the resident environment remains as free of accident hazards as is possible;
o Section 483.65(a)(1)-(3), requiring that the facility establish an infection control program;
o Section 483.10(e)(1), providing that the resident has the right to personal privacy;⁽⁴⁾
o Section 483.70(h)(4), requiring that the facility maintain an effective pest control program; and
o Several provisions of the Life Safety Code of the National Fire Protection Association, incorporated by reference in section 483.70(a).^{(5) (6)}

HCFA found that the level of noncompliance with the first requirement listed above posed immediate jeopardy, and imposed a CMP of $3,050 per day for 21 days of noncompliance (September 3, 1997 through September 23, 1997). HCFA also imposed a CMP of $50 per day thereafter for 78 days of noncompliance with the remaining participation requirements, which did not rise to the level of immediate jeopardy (September 24, 1997 through November 20, 1997). The total CMP imposed by HCFA was $66,950.

Legal Authority

Long-term care facilities are subject to periodic surveys to determine their compliance with the statutory and regulatory requirements of participation. See generally sections 1819 and 1919 of the Social Security Act (Act); 42 C.F.R. Parts 483, 488, and 489. The Act and the regulations provide a variety of remedies, including the imposition of CMPs, to enforce prompt compliance with program requirements. See sections 1819(h) and 1919(h) of the Act; 42 C.F.R. Part 488, Subpart F. The Act provides authority for HCFA to impose CMPs of up to $10,000 per day on facilities that are not in substantial compliance with Medicare and Medicaid participation requirements. Sections 1819, 1919, and 1866(b)(2) of the Act. Regulations limit the amount of CMPs imposed to amounts set at $50 increments within two ranges. 42 C.F.R. � 488.438(a). The upper range is from $3,050 to $10,000 per day and applies whenever a deficiency is found at the immediate jeopardy level. 42 C.F.R. � 488.438(a)(1)(i). The lower range is from $50 to $3,000 per day and applies when the deficiencies found have the potential to cause more than minimal harm but do not constitute immediate jeopardy. 42 C.F.R. � 488.438(a)(1)(ii).

For purposes of surveys of facilities like Price Hill, the regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. "Immediate jeopardy" is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." Id.

Before the ALJ, a facility must prove substantial compliance by the preponderance of the evidence, once HCFA has established a prima facie case that the facility was not in substantial compliance with relevant statutory or regulatory provisions. See Cross Creek Health Care Center, DAB No. 1665 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. HHS, No. 98-3789(GEV), slip op. at 25 (D.N.J. May 13, 1999). However, HCFA's determination that a deficiency constituted immediate jeopardy must be upheld unless the facility proves that the determination was clearly erroneous. 42 C.F.R. � 498.60(c)(2); see also Koester Pavilion, DAB No. 1750, at 4 (2000).

Issues

Price Hill excepted to the following Findings of Fact and Conclusions of Law (FFCLs) in the ALJ Decision:

FFCL No. 1. Quality of care: Accidents. On September 3, 1997, the provider did not ensure that each resident received adequate supervision and assistive devices to prevent accidents, as required under 42 C.F.R. � 483.25(h)(2) [Tag F-324].

FFCL No. 2. Quality of care: Accidents. For one day only, September 3, 1997, the provider did not prove that it was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. � 483.25(h)(2) [Tag F-324].

FFCL No. 4. HCFA's determination that the provider's noncompliance with 42 C.F.R. � 483.25(h)(2) [Tag F-324] on September 3, 1997 was at an immediate jeopardy level, was not clearly erroneous.

FFCL No. 7. Quality of care: Accidents. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.25(h)(1) [Tag F-323].

FFCL No. 9. Infection control. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.65(a)(1)-(3) [Tag F-441].

FFCL No. 10. Resident rights: Privacy. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.10(d)(3) [Tag F-164].

FFCL No. 11. Physical Environment: Pest Control. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. � 483.70(h)(4) [Tag F-469].

FFCL No. 16. Life Safety Code. The provider did not prove that it was in substantial compliance with four life safety code requirements [Tag K-21, K-46, K-66, and K-68].

FFCL No. 17. HCFA had the authority to impose a CMP.

FFCL No. 18. A CMP in the amount of $6,950 is reasonable.

ALJ Decision at 4-5.

HCFA excepted to the following FFCLs:

FFCL No. 3. Quality of care: Accidents. For 20 days, September 4, 1997 through September 23, 1997, the provider proved that it was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. � 483.25(h)(2) [Tag F-324].

FFCL No. 5. Since there was no deficiency under 42 C.F.R. � 483.25(h)(2) [Tag F-324] for 20 days, September 4, 1997 through September 23, 1997, there was no immediate jeopardy during those days.

FFCL No. 6. HCFA's determination that the provider's noncompliance was at an immediate jeopardy level from September 4, 1997 through September 23, 1997, was clearly erroneous.

ALJ Decision at 4. Neither party excepted to FFCLs Nos. 8, 12, 13, 14, and 15 (ALJ Decision at 5), and we affirm them without further discussion.

Below, we first discuss the parties' challenges to the ALJ findings regarding whether Price Hill was in substantial compliance with the participation requirement at section 483.25(h)(2) (FFCL Nos. 1-3). We then discuss the parties' challenges to the ALJ's findings regarding whether Price Hill's noncompliance with section 483.25(h)(2) posed immediate jeopardy (FFCL Nos. 4-6). We proceed to discuss Price Hill's challenges to the ALJ's findings regarding the remaining participation requirements (FFCL Nos. 7, 9, 10, 11 and 16). Finally, we discuss Price Hill's challenges to the ALJ's findings regarding the authority to impose a CMP and the amount of the CMP (FFCL Nos. 17 and 18).

Standard of Review

Our standard of review on disputed issues of fact is whether the ALJ Decision is supported by substantial evidence on the record as a whole. See, e.g., Koester Pavilion. Our standard of review as to disputed issues of law is whether the ALJ Decision is erroneous. Id.

1. Substantial evidence in the record as a whole supports the ALJ's findings that Price Hill was not in substantial compliance with the participation requirement at section 483.25(h)(2) on September 3, 1997 but was in substantial compliance afer that date.⁽⁷⁾

The Statement of Deficiencies identified a deficiency under section 483.25(h)(2) based on evidence concerning Price Hill's care of Resident 49. This resident, who had diagnoses of brain injury, major depression and organic personality syndrome, had attempted to leave the facility unsupervised on about 30 different days within a six-week period (including multiple times on some of those days). His care plan required that he wear a bracelet that would trigger an audible alarm if he were exiting the facility and that he be checked every 30 minutes. Although Price Hill had an alarm system in place, Petitioner left the facility without Price Hill's knowledge on at least two occasions, August 25 and September 3, 1997. On the latter date, Resident 49 first attempted to leave the facility at 6:30 a.m., but was redirected to his room. Sometime between 6:30 and 7:00 a.m., Resident 49 succeeded in leaving the facility without the alarm sounding. At 7:45 a.m., a local hospital notified Price Hill that Resident 49 had been picked up on a nearby street and had sustained numerous injuries. Later the same day, at Price Hill's request, the company that had installed its alarm system assessed the entire system and found a malfunctioning keypad, which it replaced. The invoice showed that the by-pass feature on the keypad was discontinuing the alarm as soon as the exit door closed.

HCFA found that Price Hill was not in substantial compliance with section 483.25(h)(2) from September 3 through September 23 based on the surveyors' finding that Price Hill did not have a system in place to monitor or test the operation of each resident's alarm bracelet until September 23, 1997. (HCFA later explained that it found that the deficiency was corrected on September 26, not September 23, but that it was giving Price Hill the benefit of a clerical error in its letter. HCFA Br. dated 5/30/01, at 2, n.1.) HCFA determined this deficiency posed immediate jeopardy and imposed a CMP of $3,050 per day on this basis.

The ALJ agreed that a deficiency that posed immediate jeopardy existed on September 3, 1997, but also found that Price Hill was in substantial compliance with section 483.25(h)(2) after September 3 (FFCLs Nos. 1 through 3). While the ALJ stated that she could not conclude from the evidence that the keypad or any other component of the alarm system was malfunctioning prior to September 3, she concluded that Price Hill was nevertheless on notice on August 25, the previous date Resident 49 left the facility, that it needed to take additional action to prevent his leaving undetected. The ALJ found, however, that once Price Hill had the keypad repaired, there was no longer any deficiency because the alarm bracelets had not malfunctioned and were not likely to malfunction. The ALJ based this conclusion on manufacturer's specifications for Cotag alarm bracelets (at P. Ex. 13). The specifications indicated that the bracelets would beep when the voltage of the batteries became low, and contained no indication that the bracelets should be tested to make sure they were working. The ALJ also relied on the testimony of Sondra Dee Schoemaker, one of Price Hill's nurses, that Resident 49's alarm bracelet "worked very well on alarming." ALJ Decision at 10, quoting Tr. at 589.

Price Hill took the position that there was no basis for any finding of noncompliance with section 483.25(h)(2). Price Hill contended that the ALJ's reasoning was faulty because she placed upon Price Hill the obligation to detect an unforeseen failure of its alarm system. According to Price Hill, this made it the "absolute insurer" of the alarm system. P. Br. dated 4/26/01, at 6. Price Hill stated that while it might be appropriate for a resident to seek monetary damages on a strict liability basis against the manufacturer of a defective device, it was not appropriate to assess a CMP against a provider who uses that device.

We disagree that the effect of the ALJ Decision was to make Price Hill the "absolute insurer" of its alarm system. This was not the ALJ's intent, as shown by her reliance on the Board's holding in a prior decision that the regulatory standard in section 483.25(h) "does not amount to strict liability." ALJ Decision at 8, citing Woodstock Care Center, DAB No. 1726, at 27 (2000). Moreover, it is clear from the facts of the case that Price Hill was not held strictly liable for the malfunctioning of its alarm system. That Resident 49 was able to leave the facility undetected on August 25 should have suggested to Price Hill the possibility that the alarm system was malfunctioning. Indeed, since Price Hill's nurses noted that the alarm sounded on some other occasions when Resident 49 left the facility (see, e.g., HCFA Ex. 18, at 33, 37), the absence of any such remark in the nurses' notes regarding the incident on August 25 indicates that the nurses most likely knew that the alarm had not worked then. Moreover, Price Hill should have realized the importance of having the alarm system repaired quickly since Resident 49 had made numerous attempts to leave the facility during the preceding weeks and was thus likely to make another attempt soon. Since Price Hill was on notice both that its alarm system might have been malfunctioning and that Resident 49 made frequent attempts to leave the facility, Price Hill can hardly claim that the ALJ was holding it strictly liable for an event which was beyond its power to control.

HCFA on the other hand argued that the ALJ erred in finding that no CMP should be imposed based on section 483.25(h)(2) after September 3. HCFA questioned the ALJ's finding that Price Hill used Cotag alarm bracelets rather than another type of alarm bracelet which the manufacturer stated required daily testing (WanderGuard). HCFA asserted that Price Hill did not provide the Cotag specifications to the surveyors, did not mention them in its plan of correction or during informal dispute resolution, and did not include them in the documents exchanged prior to the hearing. HCFA also took the position that Price Hill was responsible for checking the alarm bracelets to assure that they were working even if they were manufactured by Cotag. HCFA contended that the ALJ should have concluded that the manufacturer's instructions for WanderGuard alarm bracelets were equally applicable to Cotag alarm bracelets.⁽⁸⁾

We are not persuaded that there is any error in the ALJ's finding that Price Hill was in substantial compliance with section 483.25(h)(2) after September 3.⁽⁹⁾ Rhonda Sims, a nurse who worked at Price Hill, testified that Price Hill used Cotag alarm bracelets. Tr. at 486. The ALJ stated that she found Ms. Sims to be very credible and noted that Ms. Sims' testimony was corroborated by Ms. Schoemaker, who testified that Price Hill was given the Cotag specifications when its alarm system was put into place. ALJ Decision at 10; Tr. at 582, 587. The Board has held that in considering the ALJ's assessment of witnesses' credibility, "we must abide by that determination absent a compelling reason not to." Bernard J. Burke, M.D., DAB No. 1576, at 14 (1996); see also Woodstock Care Center, at 8-9 (2000). We find no such compelling reason here. HCFA did not present any testimony that Price Hill used a brand of alarm bracelet other than Cotag, nor did it object to the admission of the manufacturer's specifications for Cotag alarm bracelets as an exhibit.⁽¹⁰⁾

Furthermore, there is substantial evidence to support the ALJ's finding that the Cotag alarm bracelets used by Price Hill were not malfunctioning and were not likely to malfunction and thus did not need to be tested.⁽¹¹⁾ As previously noted, Ms. Schoemaker testified that Resident 49's alarm bracelet worked very well.⁽¹²⁾ In addition, the record is devoid of any evidence that there was a problem with the alarm bracelets of the four other Price Hill residents who wore them. Moreover, the Cotag specifications do not contain any mention of a need for testing. The specifications describe the bracelets as "self-monitoring" due to the fact that they emit an audible beep when the voltage is low. ALJ Decision at 14, citing P. Ex. 13, at 1. The specifications also state that the bracelets have long-life power cells which last three years in the application used by Price Hill, significantly longer than the 15 months the ALJ found Price Hill had had the bracelets as of October 1997. Id. Further, HCFA offered no evidence whatsoever to support its position that the WanderGuard instructions for testing were applicable to the Cotag alarm bracelets, or that testing irrespective of a self-monitoring feature was an accepted standard in the community. HCFA counsel's unsupported speculation as to the reasons why the Cotag alarm bracelets should have been tested is not entitled to any weight.

HCFA also appeared to argue that the ALJ's finding that it was unnecessary to test Price Hill's alarm bracelets was predicated on an erroneous finding by the ALJ that Price Hill had several other approaches to prevent Resident 49 from leaving. According to HCFA, the only approaches that directly addressed this problem were the alarm system and frequent monitoring. Although the ALJ did state that "the provider's audible alarm system was only one of at least nine different methods and approaches the provider used to prevent Resident 49 from leaving the facility without supervision" (ALJ Decision at 12), nothing in the decision indicates that this was a basis for her finding that it was unnecessary to test Price Hill's alarm bracelets. Accordingly, even if the quoted statement were wrong, that would not provide a basis for reversing the finding in question.

HCFA argued in addition that repairing the keypad that was malfunctioning on September 3 was not sufficient to correct the deficiency since Price Hill had not determined why Resident 49 was able to leave undetected on August 25. This argument has no merit since there is uncontradicted testimony in the record that the company that repaired the keypad on September 3 did so only after checking the entire alarm system. Tr. at 489.

For the reasons explained above, we conclude that FFCL Nos. 1 through 3 are supported by substantial evidence in the record as a whole. We therefore sustain these FFCLs.

2. The ALJ did not err in finding not clearly erroneous HCFA's determination that Price Hill's noncompliance with section 483.25(h)(2) on September 3, 1997 posed immediate jeopardy.

The Statement of Deficiencies identified Price Hill's noncompliance with section 483.25(h)(2) as posing immediate jeopardy. The ALJ found that HCFA's determination that there was immediate jeopardy on September 3 was not clearly erroneous (FFCL No. 4). The ALJ further found that there was no immediate jeopardy after September 3 because Price Hill was in substantial compliance with this participation requirement after that date (FFCL Nos. 5 and 6).

Price Hill challenged FFCL No. 4 on the ground that HCFA program representative Douglas Wolfe "virtually acknowledged" in his testimony that immediate jeopardy did not exist. P. Br. dated 4/26/01, at 3. However, the cited testimony pertains to whether Resident 49 was in immediate jeopardy after September 3. Tr. at 312. Mr. Wolfe also testified that Resident 49 was in immediate jeopardy on September 3 because Resident 49 had left the facility without Price Hill's knowledge, Price Hill did not know where he was, and he suffered harm. Tr. at 303-304.

Price Hill also appeared to argue that the determination of immediate jeopardy was clearly erroneous because the surveyors' supervisor initially instructed the surveyors to inform Price Hill that the scope and severity of the deficiency was at a level which did not constitute immediate jeopardy. However, the record shows that the surveyors advised Price Hill that this determination was subject to further review. Tr. at 123, 211. In any event, the process by which HCFA reached its determination of immediate jeopardy is not relevant.

Finally, Price Hill asserted that HCFA surveyor Nancy Thompson "acknowledged" in her testimony that the scope and severity of the deficiency under section 483.25(h)(2) was lessened because a second resident who was cited under this deficiency was deleted from the Statement of Deficiencies after informal dispute resolution. P. Br. dated 4/26/01, at 8. However, Ms. Thompson in fact testified that the scope and severity of the deficiency remained the same because the definition of immediate jeopardy includes actual harm to one resident. Tr. at 277-278.

Since Price Hill provided no basis for reversing the ALJ's finding that HCFA's determination that immediate jeopardy existed on September 3 was not clearly erroneous, we sustain FFCL No. 4.

We also sustain FFCL Nos. 5 and 6, the ALJ's findings that there was no immediate jeopardy afer September 3, which HCFA challenged on appeal. In order to find that immediate jeopardy existed after September 3, we would first have to find that there was a deficiency under section 483.25(h)(2) during this period. As discussed above, however, substantial evidence in the record supports the ALJ's finding that Price Hill was in substantial compliance with section 483.25(h)(2) after September 3.

3. The ALJ did not err in finding that Price Hill did not prove that it was in substantial compliance with 42 C.F.R. �� 483.25(h)(1), 483.65(a)(1)-(3), 483.10(d)(3), and 483.70(h)(4), and four Life Safety Code requirements.

As noted earlier, once HCFA has established a prima facie case that a facility was not in compliance with one or more participation requirements, the facility must prove substantial compliance by the preponderance of the evidence. The ALJ found that Price Hill did not prove that it was in substantial compliance with five participation requirements in addition to the one discussed above (FFCL Nos. 7, 9, 10, 11, and 16). On appeal, Price Hill argued that it had proved that it was in substantial compliance with these participation requirements or that, in some instances, HCFA failed to make a prima facie case that there was a deficiency. As discussed below, we conclude that Price Hill did not show that HCFA failed to make a prima facie case or point to any evidence in the record that would establish that Price Hill was in substantial compliance with any of the participation requirements in question. Accordingly, we sustain the findings in question.⁽¹³⁾

FFCL No. 7 - Quality of Care: Accidents

The Statement of Deficiencies stated that Price Hill failed to maintain a resident environment as free from accident hazards as is possible, as required by section 483.25(h)(1). The surveyors reported that, on September 23, an unlocked medicine cart was observed to be unattended for nine minutes while a nurse passed out medications to patients. The cart was not within view of a staff person and residents were in the area of the cart. In addition, from September 23 through September 25, a supply closet with items including denture cleaning tablets, shaving cream, and disposable razors was observed to be unlocked on a residential floor where staff are not always present. Further, on one occasion, a razor was observed sticking out of the disposable sharps container in a patient room. The razor was within reach and was easily removable. HCFA Ex. 3, at 11; Tr. at 78, 139-147, 171.

Price Hill disputed the ALJ's finding that it did not prove that it was in substantial compliance with section 483.25(h)(1). Price Hill took the position that there was no "accident hazard," defined in the interpretive guidelines given to the surveyors as "physical features in the nursing home that can endanger a resident's safety." State Operations Manual, Chapter 10, Appendix P, Rev. 20, 09-07, PP-104. Price Hill asserted that: no resident touched the medication cart or the supply closet during the time in question; there was no evidence that any medication was in the cart at the time; the supply closet did not contain anything that would have harmed the residents such as cleaning solutions, medical supplies or medications; the supply closet was equipped with a key padlock with a latch as well as a standard key lock; and there was no finding that the supply closet door was open.

We fail to see how the factors cited by Price Hill are evidence of substantial compliance. The intent of the regulation is to prevent accidents; thus, the fact that no accident occurred because no resident touched the unattended cart or the unlocked supply closet does not establish compliance with this regulation.⁽¹⁴⁾ The language "can endanger" in the State Operations Manual is consistent with this reading of the regulation. Moreover, Price Hill did not point to any testimony or other evidence to refute the logical inference that a medicine cart being used to pass out medications contained medications. In addition, Price Hill did not point to any testimony or other evidence that the contents of the supply closet could not have caused any harm to a resident if used improperly (as one might expect to happen if a resident was cognitively impaired). Furthermore, Price Hill did not show that the supply closet could not have been opened even if it was equipped with locks or the door was closed. Finally, Price Hill did not dispute that the razor was not properly stored in the sharps container.

Accordingly, we sustain FFCL No. 7.

FFCL No. 9 - Infection Control

The Statement of Deficiencies stated that Price Hill failed to establish an infection control program under which it investigates, controls, and prevents infections in the facility; decides what procedures, such as isolation, should be applied to an individual resident; and maintains a record of incidents and corrective actions related to infections, as required by section 483.65(a)(1)-(3). According to the surveyors, Price Hill's infection control policy for scabies did not state that scabies is highly contagious, and did not mention the use of universal precautions, identify the mode of transmission, or plan how to prevent the spread of scabies, nor had Price Hill conducted any in-service training on scabies in the past year.⁽¹⁵⁾ Instead, the policy merely stated that any diagnosis of scabies will be treated as ordered by the primary physician and that the affected resident's dirty clothing and bed linen are to be washed and dried. The surveyors noted that records for both Resident 4 and her roommate Resident 5 showed that they had been seen on August 26, 1997 by a dermatologist, who made a tentative diagnosis of, and ordered treatment for, scabies in the case of both residents. On September 24, Resident 4 was observed complaining of intense itching and to have red, raised, scaly, crusty areas on several areas of her body. Although Price Hill's nurses notified Resident 4's physician of a skin tear caused by scratching, they did not mention the underlying skin condition. On September 25, Resident 5 was observed lying in Resident 4's bed, but none of the three nurse aides who walked by or came in the room tried to remove her from the bed. HCFA Ex. 3, at 18-20; HCFA Ex. 11, at 2; HCFA Ex. 13, at 2; Tr. at 188-189, 199-201.

Price Hill disputed the ALJ's finding that it did not prove that it was in substantial compliance with section 483.65(a)(1)-(3). Price Hill acknowledged that Resident 4 had had scabies (which it said that she had contracted before coming to Price Hill), but pointed to the testimony of Ms. Sims that Resident 4's scabies had been successfully treated, that the skin condition observed by the surveyors was not scabies, and that the dermatologist had determined after the survey that Resident 4 did not have scabies. Price Hill took the position that the fact that Resident 4's scabies did not spread to other patients "points more to an effective infection control program than a lack thereof." P. Br. dated 4/26/01, at 12.

We fail to see how the factors cited by Price Hill are evidence of substantial compliance. Price Hill did not dispute that its written infection control policy did not include any procedures for preventing the spread of scabies other than washing the dirty clothes and bed linen of an affected resident. This policy did not provide for the type of program required by the regulation, nor did Price Hill show that it had implemented such a program as a matter of practice. Since Resident 4 had been diagnosed a month earlier with scabies and continued to have a skin condition which resembled scabies, the failure of Price Hill's nurses to report this to her physician indicates that the nurses were not aware that this was a highly contagious condition that needed to be successfully treated. Furthermore, the nurses' failure to remove Resident 5 from Resident 4's bed indicates that they were not aware of how scabies is transmitted. Since Price Hill did not have the type of infection control program required by the regulation, it is simply irrelevant if Resident 4's scabies could not have spread because she no longer had an active case of scabies, or if Resident 5 did not contract scabies despite her possible exposure to it.

Accordingly, we sustain FFCL No. 9.

FFCL No. 10 - Resident Rights: Privacy

The Statement of Deficiencies stated that Price Hill failed to afford residents the right to personal privacy (defined as including personal care), citing section 483.10(d)(3). The surveyors interviewed four residents who complained that staff knocked on the closed doors to their rooms but then entered without waiting for the resident to state that they may come in. In addition, on September 24, the surveyors observed two residents, Resident 4 and Resident 31, who were receiving personal care in their rooms without being properly covered or draped when the curtain was only partially pulled or not pulled at all. HCFA Ex. 3, at 2-4; Tr. at 78-79, 188-191, 413. The surveyors noted that other staff entered these residents' rooms during this time without waiting for a response from the staff providing the care.

Price Hill disputed FFCL No. 10 on the ground that the "facts alleged by HCFA" have nothing to do with section 483.10(d)(3), the regulation cited in this FFCL and in the Statement of Deficiencies, and that HCFA had therefore failed to make a prima facie case of a deficiency. P. Br. dated 4/26/01, at 13. Section 483.10(d)(3) pertains to the resident's right to participate in planning care and treatment, not to the resident's right to privacy, which is addressed in section 483.10(e)(1). However, the Statement of Deficiencies quotes the language of section 483.10(e)(1), and HCFA corrected the citation error at the hearing without any objection by Price Hill. Tr. at 12-13. We therefore find that HCFA made a prima facie case that there was a deficiency under section 483.10(e)(1), and that the ALJ's citation of section 483.10(d)(3) was harmless error.

Price Hill also asserted that the citation of a deficiency under this tag improperly relied on hearsay concerns of other residents and on the surveyor's perception that Resident 4's privacy was being disturbed rather than on evidence that Resident 4 believed her privacy was being disturbed or that staff actually disturbed her privacy. We see nothing in the regulation that requires that the resident have asserted that his or her right to privacy was violated in order for there to be a deficiency. However, we need not resolve this question or address Price Hill's argument about reliance on the resident interviews. Price Hill did not contest the surveyor's observations regarding Resident 31, nor argue that they were insufficient to show noncompliance with section 483.10(e)(1). Thus, there is substantial evidence to support the ALJ's finding of a deficiency.

Accordingly, we sustain FFCL No. 10.

FFCL No. 11 -- Physical Environment: Pest Control

The Statement of Deficiencies stated that Price Hill failed to maintain an effective pest control program so that the facility is free of pests and rodents, as required by section 483.70(h)(4). On September 23, the surveyors observed small, black, beetle-like insects in boxes of cake mix which had been opened and resealed in plastic storage bags. The surveyors also observed two live insects and one insect larva on the shelf next to the cake mix boxes. In addition, the surveyors noted flies in the kitchen, the first floor hallways and the first floor kitchenette, and six residents confirmed in an interview that there were flies. HCFA Ex. 3, at 21-22; Tr. at 83, 165-166, 389-391.

Price Hill took the position that HCFA failed to make a prima facie case of a deficiency under section 483.70(h)(4). Price Hill stated that it immediately removed the materials found to contain bugs, that live bugs were not seen again after their removal, that the bugs in the food were dead, and that it was unknown where the bugs came from or how long they were present. In addition, Price Hill stated that "flies are numerous during certain times of the year" and that it "has no duty to ferret out every fly." P. Br. dated 4/26/01, at 15.

Price Hill's position that HCFA failed to make a prima facie case is without merit. The fact that Price Hill removed bugs from the food storage area only after the surveyors pointed them out supports, rather than undermines, the finding that Price Hill did not have an effective pest control program since Price Hill admitted that it did not know how long the bugs had been there. In addition, even if the presence of bugs in the food storage area was an isolated occurrence, that did not obviate the need for an effective pest control program. Price Hill's suggestion that dead bugs could safely be consumed is clearly contrary to commonly accepted standards of sanitation and in any event ignores the fact that live bugs were also present. Furthermore, even if there tend to be more flies in the early fall (when the survey was conducted), an effective pest control program would have addressed that situation. (Nothing in the deficiency finding indicates that Price Hill was expected to have eradicated every single fly, however.) Thus, HCFA made a prima facie case of a violation of section 483.70(h)(4) based on the evidence cited by the surveyors. Moreover, Price Hill did not point to any evidence that would establish that it was in substantial compliance with this requirement.

Accordingly, we sustain FFCL No. 11.

FFCL No. 16 - Life Safety Code.

The Statement of Deficiencies stated that Price Hill did not meet several elements of the Life Safety Code Standard. The surveyors found that several doors which served as smoke barriers did not close and latch into the door frame to prevent the entry of fire and combustion (Tag K-21); that Price Hill did not make adequate provision for emergency lighting for 60 minutes since it was unable to document that it inspected and tested its emergency generator on a regular basis (Tag K-46); that Price Hill either did not have or did not properly maintain self-closing metal containers in smoking areas for the disposal of cigarettes (Tag K-66); and that Price Hill did not provide adequate ventilation in its boiler room (Tag K-68). HCFA Ex. 3, at 25-29.

Price Hill disputed FFCL No. 16 on the ground that it "was not previously cited under LSC Tags K-21, K-46 and K-66," and that "these conditions" were fixed by November 21, 1997. P. Br. dated 4/26/01, at 15. In addition, Price Hill contended that it did not violate Tag K-46 since it has battery packs for emergency lighting.⁽¹⁶⁾ Id.

We fail to see how the factors cited by Price Hill are evidence of substantial compliance. Price Hill did not cite any requirement that a deficiency be repeated in order to determine that a facility is not in substantial compliance with a participation requirement. Under section 488.438(f)(1), a facility's "history of noncompliance, including repeated deficiencies," is instead a factor to be considered in setting the amount of the penalty.

In addition, Price Hill did not cite anything in the record to support its assertion that it corrected three of the cited violations nor did it explain why a CMP could not properly be imposed for periods prior to the date of correction. Finally, the testimony that Price Hill cited to show that it relied on battery packs rather than a generator as its source of emergency lighting in fact shows the contrary. See Tr. at 406-407.

Accordingly, we sustain FFCL No. 16.

4. The ALJ did not err in finding that a CMP was authorized and that a $6,950 CMP was reasonable.

Price Hill disputed the ALJ's findings that HCFA was authorized to impose a CMP and that a $6,950 CMP was reasonable in amount (FFCL Nos. 17 and 18). Price Hill stated that it disputed "the authority of HCFA to impose a CMP generally," apparently based on its position that it proved that it was in substantial compliance with all of the participation requirements at issue. Price Hill appeared to argue in the alternative that: (1) a CMP of $3,050 for the noncompliance on September 3 was not reasonable since in its view the immediate jeopardy lasted only 45 minutes (from 7:00 a.m. to 7:45 a.m. on September 3) and (2) the remaining CMP of $3,900 was not justified by "the period of noncompliance" of the remaining deficiencies. P. Br. dated 4/26/01, at 16.

Price Hill's argument that the ALJ erred in finding that a CMP was authorized has no merit since we sustain the ALJ's findings that Price Hill was not in substantial compliance with the participation requirements in question. Moreover, $3,050 per day is the minimum amount of a CMP that may be imposed where there has been a finding of a deficiency that poses immediate jeopardy. See 42 C.F.R. � 488.438(a)(1)(i). Thus, the ALJ did not err in finding that a CMP of $3,050 was reasonable based on noncompliance on September 3 which posed immediate jeopardy. Furthermore, the minimum CMP that may be imposed for noncompliance that does not pose immediate jeopardy is $50 per day. See 42 C.F.R. � 488.438(a)(1)(ii). Thus, the ALJ did not err in finding that an additional CMP of $3,900 ($50 x 78 days) was justified.

Accordingly, we sustain FFCL Nos. 17 and 18.

Conclusion

For the reasons set out above, we sustain the ALJ Decision in its entirety and affirm and adopt each of the FFCLs.

Judith A. Ballard

M. Terry Johnson

Marc R. Hillson
Presiding Board Member

1. Although HCFA has been renamed the Centers for Medicare & Medicaid Services (see 66 Fed. Reg. 35437 (July 5, 2001)), we use "HCFA" since that acronym was used to refer to the agency at the time the actions at issue here were taken.

2. We have considered each and every argument presented by the parties in reaching the findings and conclusions set forth here, although particular arguments may not be specifically addressed.

3. The surveyors reported their findings in a Statement of Deficiencies on HCFA Form 2567L and cited each deficiency in compliance with a participation requirement by an "F Tag" number corresponding to a particular regulatory provision. See HCFA Exs. 2 and 3 (the latter is the amended version with plan of correction). Each deficiency was evaluated on a scale that reflected the scope and severity of the problem.

4. As discussed later, the ALJ Decision incorrectly cited this provision as section 483.10(d)(3).

5. We do not identify the additional participation requirements with which HCFA found Price Hill non-compliant since the ALJ found that HCFA had failed to establish a prima facie case of noncompliance with those requirements and on appeal HCFA did not challenge the ALJ's findings to that effect.

6. The ALJ Decision cited directly to the tag numbers in HCFA's Statement of Deficiencies corresponding to certain Life Safety Code requirements, and did not cite section 483.70(a).

7. The summary below of the undisputed facts is drawn from the ALJ Decision and the record before the ALJ.

8. The WanderGuard instructions provided in part:

Sudden impact could damage signaling device components and, in rare instances, the battery could fail prematurely. The only way you'll know is by testing signaling devices daily and after impact, if applicable.

HCFA Ex. 39, at 2.

9. The ALJ's discussion of this finding incorrectly identifies the issue as "whether it was likely that a resident would suffer serious injury, harm, impairment, or death." ALJ Decision at 14 (emphasis in original). This is the basis for determining whether a deficiency posed immediate jeopardy, a question which is not raised unless it has been determined that a deficiency existed. Nevertheless, this misstatement of the issue constitutes harmless error since the ALJ's determination that there was no risk of any harm to a resident is a proper basis for finding substantial compliance.

10. Price Hill's plan of correction referred to a "wanderguard system." HCFA Ex. 3, at 17. One of the surveyors testified that this was the basis for her belief that Price Hill used WanderGuard alarm bracelets. Tr. at 176. However, as the ALJ indicated at the hearing, Price Hill might have been using this term in a generic sense. See Tr. at 188.

11. HCFA claimed that the ALJ's emphasis on the fact that the bracelets did not malfunction from September 4 through September 23 was misplaced. HCFA stated that the emphasis should instead be on whether Price Hill had taken steps to assure that the alarm bracelets would continue to work in the future since the regulation requires a facility to prevent accidents. As discussed below, however, there is substantial evidence to support the ALJ's determination that the bracelets did not need to be tested to assure their continued reliability.

12. Although HCFA in its appeal questioned the logic of concluding that the alarm bracelets were working because alarms were routinely heard, HCFA did not cross-examine Ms. Schoemaker on this point or introduce its own witness to address it.

13. The background information provided below is drawn from the undisputed facts in the record since the ALJ Decision does not contain any background information or discuss any evidence in support of these findings.

14. It is also possible to view this (as well as Price Hill's argument regarding some of the other participation requirements discussed below) as an argument that the deficiency did not have a potential for more than minimal harm, in which case a CMP could not properly be imposed. However, the regulations permit a provider to challenge the level of noncompliance found by HCFA only in limited circumstances not present here. 42 C.F.R. � 498.3(b)(14).

15. Scabies is a highly contagious mite transmissible via skin-to-skin contact or contact with an inanimate object that an affected person has used within the past 24 hours. Tr. at 200.

16. Price Hill's brief mistakenly referred to Tag K-21 rather than Tag K-46, which involves emergency lighting.