SUBJECT: Barbourville Nursing Home,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Barbourville Nursing Home (BNH or Petitioner) appealed a January 29, 2004 decision by Administrative Law Judge (ALJ) Richard J. Smith sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a civil money penalty (CMP) of $4,050 per day on BNH for the period June 14 through June 19, 2001. Barbourville Nursing Home, DAB CR1135 (2004)(ALJ Decision). The ALJ concluded that BNH failed to substantially comply with five Medicare participation requirements and upheld CMS's finding that BNH's noncompliance with two of these requirements posed immediate jeopardy to resident health and safety. The ALJ found that BNH's noncompliance with 11 additional participation requirements was established "by operation of law" since BNH did not challenge them in its hearing request. ALJ Decision at 3. The ALJ further found that it was unnecessary for him to address whether BNH substantially complied with 12 more participation requirements in order to sustain the CMP amount since the two immediate jeopardy deficiencies, together "with the relevant factors concerning the civil money penalty, support the imposition of the civil money penalty and the reasonableness of its amount." ALJ Decision at 3.

On appeal, BNH argued that the ALJ erred in upholding CMS's determination of immediate jeopardy with respect to the participation requirements at 42 C.F.R. �� 483.25(c)(2) and 483.65(a). BNH also disputed some of the findings that supported the ALJ's conclusion that BNH failed to substantially comply with these requirements "[t]o the extent that they may be or may have been relied upon to support the immediate jeopardy determination." Request for Review at 12. BNH argued in addition that, even if there was immediate jeopardy, the CMP amount was not reasonable because there was no actual harm and no evidence of systemic problems.

For the reasons explained below, we uphold the ALJ's determination that BNH failed to substantially comply with the two participation requirements at issue, his determination that both of these deficiencies posed immediate jeopardy, and his determination that the CMP amount of $4,050 per day was reasonable.

Applicable Legal Standards

Based on survey findings, surveyors prepare a Statement of Deficiencies (SOD) which identifies and describes each failure to meet a participation requirement (deficiency) under a separate "tag" number. A remedy may be imposed against a facility that is not in "substantial compliance" with one or more participation requirements. 42 C.F.R. � 488.408(d). A facility is not in "substantial compliance" with a participation requirement if it is found to have a deficiency that results in actual harm to a resident or poses a risk of more than minimal harm to resident health and safety. 42 C.F.R. � 488.301. "Noncompliance" is defined as "any deficiency that causes a facility to not be in substantial compliance." Id.

The seriousness of deficiencies is assessed on a scale that considers scope (whether the deficiency is isolated, pattern, or widespread) and severity (how great a harm, or potential for harm, is presented by the deficiency). 42 C.F.R. � 488.404. The most serious level of noncompliance is "immediate jeopardy," which 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." 42 C.F.R. � 488.301. "Jeopardy" generally means danger, hazard, or peril. See Black's Law Dictionary (6^th Ed.)(West's Pub. 2000). "The focus of the determination of immediate jeopardy is on how imminent the danger appears and how serious the potential consequences would be." Woodstock Care Center, DAB No. 1726, at 38 (2000) (citing 42 C.F.R. � 488.301), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). Moreover, a "mere risk of serious harm is not equivalent to a likelihood of serious harm." Innsbruck Healthcare Center, DAB No. 1948, at 5 (2004). Immediate jeopardy can exist regardless of the scope of the deficiency (i.e., whether it is isolated, pattern or widespread). State Operations Manual � 7500 (scope and severity grid showing isolated, pattern and widespread deficiencies constituting immediate jeopardy) (grid also published at 59 Fed. Reg. 56,116, 56,183 (Nov. 10, 1994)).

A CMP in the range of $3,050-$10,000 per day of noncompliance may be imposed for a deficiency that poses immediate jeopardy. 42 C.F.R. � 488.438(a)(1)(i). A CMP in the range of $50-$3,000 per day may be imposed for one or more deficiencies that do not constitute immediate jeopardy but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. � 488.438(a)(1)(ii).

If a facility timely appeals a finding of noncompliance resulting in a CMP, it has a right to a hearing before an ALJ. Before the ALJ, CMS must make a prima facie case that the facility was not in substantial compliance with one or more participation requirements; if CMS does so, then the facility will prevail only if it proves substantial compliance by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); cf. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789(GEB), slip. op. at 25 (D.N.J., May 13, 1999). The ALJ must uphold CMS's determination that the deficiency constituted immediate jeopardy unless the facility proves that the determination was clearly erroneous. 42 C.F.R. � 498.60(c)(2); see also Woodstock Care Center.

Standard of Review

The standard of review on a disputed issue of law is whether the ALJ decision is erroneous. The standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence in the record as a whole. Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs; see, e.g., Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home v. Dep't of Health & Human Srvcs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003).

Procedural Background

The Kentucky Cabinet for Health Services (State survey agency) conducted an annual relicensure and recertification survey of BNH on June 12-15, and an extended survey on June 15-16, 2001. The State survey agency found that BNH failed to substantially comply with 29 participation requirements. ⁽¹⁾

CMS notified BNH by letter dated June 26, 2001 that the survey found that BNH "was not in substantial compliance with the participation requirements and that conditions in [the] facility constituted immediate jeopardy to resident's health and safety." The letter further stated that "[b]ased on the findings of the June 16, 2001 survey," CMS was "imposing a CMP in the amount of $4,050 per day effective June 14, 2001 and continuing until the jeopardy is removed or your facility is terminated." The letter continued: "We considered factors identified at 42 CFR 488.438(f) in setting the amount of the CMP being imposed for each day of noncompliance."

BNH requested a hearing pursuant to 45 C.F.R. Part 498. The ALJ conducted a hearing from May 20 - 22, 2002. ALJ Decision at 2. Following receipt of the ALJ Decision, BNH timely requested Board review.

The ALJ's Findings of Fact and Conclusions of Law

The ALJ Decision contains the following findings of fact and conclusions of law (FFCLs):

1. Petitioner failed to substantially comply with participation requirements during the period from June 14 to June 19, 2001.

2. CMS's determination that Petitioner's deficiencies constituted immediate jeopardy to residents was not clearly erroneous[.]

3. The amount of the civil money penalty is reasonable.

ALJ Decision at 6, 28, and 30.

Below, we address in turn each of the two participation requirements as to which the ALJ determined there was noncompliance at the immediate jeopardy level and explain why we uphold the ALJ's determinations. ⁽²⁾ We then discuss why we affirm the ALJ's decision to uphold the CMP amount imposed by CMS.

1. 42 C.F.R. � 483.25(c) (Tag F-314)

Among the requirements a facility must meet to participate in the Medicare program are standards for quality of care which provide as follows:

(c) Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that-

(1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and

(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. � 483.25(c).

The SOD reported findings under this requirement relating to three residents. The SOD stated that BNH's "failure to provide pressure sore treatment in accordance with accepted infection control practices and failure to follow facility policies and procedures in order to promptly identify new skin breakdown requiring treatment, placed residents at risk of death or serious physical harm." CMS Ex. 3, at 33-34. The SOD identified this deficiency as isolated but posing an immediate jeopardy to resident health or safety. Id. at 32. As indicated above, CMS adopted the State survey agency's findings.

The ALJ upheld CMS's determination that BNH failed to substantially comply with section 483.25(c). The ALJ also upheld CMS's determination that this noncompliance posed immediate jeopardy. ALJ Decision at 28.

Below, we describe the basis on which the ALJ upheld CMS's determinations regarding the existence of the noncompliance and the immediate jeopardy. We then proceed to discuss why BNH's exceptions to the ALJ's holdings on these matters are without merit.

Basis for ALJ's finding of noncompliance

Resident 4: Resident 4 had multiple pressure sores. During the survey, one of BNH's nurses was observed caring for a pressure sore on Resident 4's coccyx. ⁽³⁾ While the nurse was changing the dressing on this pressure sore, Resident 4 experienced a bowel movement, resulting in feces getting on Resident 4's peri-anal area and on the bed linen. The nurse did not clean the feces, but applied a dressing to the pressure sore that covered the sore and some of the feces. After the dressing was completed, the nurse attempted to clean the feces by wiping the material toward the pressure sore. As a result, some feces were pushed under the dressing covering the sore. Resident 4's physician was notified of the contamination and ordered that the wound be irrigated and redressed. ALJ Decision at 7-8.

The ALJ concluded that the introduction of fecal matter into the resident's pressure sore was a basis to find that BNH failed to substantially comply with the requirement of this tag that the facility provide the resident with the necessary services to prevent infection. ALJ Decision at 10. The ALJ noted BNH's argument that Resident 4's pressure sore would not have been colonized by the bacteria in the fecal matter long enough to become infected because of the routine care provided by the facility after the dressing change in question. Id. at 10-11. The ALJ agreed that the fecal matter did not cause an instantaneous infection and stated that "it is plausible that Resident 4's sore would have been cleaned at the next regular interval," but nevertheless stated:

The risk of infection may be mathematically reduced by the periodic regularity of staff attention, but the harm is already done in the interim when the contaminant is left free to take its best shot at infecting the vulnerable resident's pressure sore.

Id. at 11.

The ALJ also found that Resident 4's nurse, who changed her gloves each time she treated one of the resident's multiple pressure sores, failed to wash her hands with soap and water after she ungloved, but instead cleaned her hands with alcohol gel. ALJ Decision at 7. The ALJ concluded that this failure was evidence of noncompliance, stating:

While Ms. Wyatt [the surveyor who observed the care of Resident 4] agreed that alcohol hand gel is acceptable to use when gloves or hands are not obviously soiled, Tr. 114-115, the crucial fact, un-refuted by Petitioner, is that in the relevant instance, there was obvious soiling.

Id. at 9-10.

Resident 2: Resident 2 had three pressure sores, two of which were Stage IV sores. The nurse who provided treatment of these sores used scissors taken from her pocket to cut away the old dressings and then used the scissors to cut new dressings without cleaning the scissors. The nurse then put the old dressings into a plastic bag sitting on the resident's bed, pulled the plastic bag through an open container of wipes that was on the bed, and then put the container of wipes back on the treatment cart. ALJ Decision at 11. ALJ Decision at 11.

The ALJ concluded that BNH failed to substantially comply with section 483.25(c) because BNH did not rebut CMS's prima facie case that the nurse used contaminated scissors to cut Resident 2's dressings or that wipes contaminated by the plastic bag that had been sitting on the resident's bed would be used to clean other residents. ALJ Decision at 12. In addition, the ALJ concluded that BNH violated section 483.25(c) because it did not show that a pressure sore Resident 2 developed in the facility was clinically unavoidable. Id. at 13.

Resident 13: Resident 13 had four pressure sores ranging in severity from Stage II to Stage IV. During the survey, one of BNH's nurses (not the same nurse who cared for Resident 4) was observed treating a pressure sore while there was fecal matter on Resident 13's body. The nurse testified that she used the bed sheet to move the feces away from the wound and that, after she completed dressing the pressure sore, she left the room and instructed a nurse aide to have Resident 13 cleaned up. The nurse also testified that after the resident was cleaned up, she returned to the resident's room and replaced the dressing after cleaning and irrigating the wound. ALJ Decision at 14.

The ALJ found that "the proper procedure is to cover the wound, remove the contaminant, and then proceed with wound care." Id. Thus, the ALJ concluded that the nurse's "decision to continue Resident 13's wound care while feces were present on his body and the bedclothes . . . contributed unnecessary risk of infection to Resident 13" and was "inconsistent with the requirements" of section 483.25(c). ALJ Decision at 15.

Basis for ALJ's finding of immediate jeopardy

The ALJ concluded that BNH had not demonstrated that CMS's determination that the deficiency under section 483.25(c) posed immediate jeopardy was clearly erroneous. ALJ Decision at 28-29. The ALJ summarized BNH's arguments regarding the immediate jeopardy determination as follows:

Petitioner argued that, as there were no systemic pressure sore treatment problems, no infected pressure sores and a good overall pressure sore healing record, the record does not support CMS's severity determination. Petitioner asserts that the increased possibility of harm at sometime in the intermediate future is not immediate jeopardy because "any theorized harm is neither likely, immediate or serious."

Id., quoting BNH's brief at 18. The ALJ further stated, however, that--

Petitioner's argument does not persuade me that CMS committed clear error in determining the pressure sore related deficiency posed immediate jeopardy to residents. Even a credible showing that the Facility provided consistent overall pressure sore care does not demonstrate that CMS's assessment of the risk to the Residents was clear error. Asserting that harm to residents was theoretical, and therefore not likely, immediate or serious, does not carry Petitioner's burden to show that CMS's perspective, that there was a the (sic) likelihood of serious harm, was clear error. Petitioner's assertion that harm was not likely, immediate or serious does not establish the fact and, therefore, does not establish that CMS erred. And, as discussed above, a history of generally competent care does not excuse or outweigh specific instances of deficient care. The instances of deficient care are what CMS determined presented the jeopardy - the suggestion that potential harm presented by deficient care would be undone by consistent care provided after the fact is insufficient to demonstrate it was clearly erroneous to determine that Residents were likely to suffer serious harm from infection and or worsening pressure sores or development of new pressure sores.

Id. at 29.

Analysis of BNH's exceptions

On appeal, BNH challenged the ALJ's conclusion that it failed to substantially comply with section 483.25(c) on several grounds. BNH asserted first and foremost that this conclusion was predicated on the erroneous assumption that the presence of bacteria "equate[s] to infection." Request for Review at 8. In essence, BNH's argument was that a pressure sore that is contaminated by bacteria will not necessarily become infected. That argument is unavailing here. A deficiency results in noncompliance whenever it has a potential for causing more than minimal harm. BNH did not dispute that the nurse caring for Resident 4 allowed the pressure sore on the resident's coccyx to become contaminated, that the contamination could potentially cause an infection, and that such an infection could cause more than minimal harm. Thus, the ALJ correctly found that BNH's care of this pressure sore was evidence of BNH's failure to substantially comply with section 483.25(c)(2).

Although BNH made the argument described above with respect to Residents 2 and 13 as well as Resident 4, and also raised other arguments involving other incidents cited in the SOD, we need not reach those arguments here. ⁽⁴⁾ CMS assessed BNH's noncompliance with section 483.25(c) as isolated, and the incident involving the pressure sore on Resident 4's coccyx is a sufficient basis for finding isolated noncompliance with this section. Moreover, BNH stated that it was disputing whether there was noncompliance only if to do so would preclude a finding of immediate jeopardy. As discussed below, however, we conclude based on this incident alone that the ALJ did not err in upholding CMS's determination of immediate jeopardy. ⁽⁵⁾

In disputing that any noncompliance posed immediate jeopardy, BNH asserted that "even if symptoms of infection arise in a wound, it is far from a matter of immediate jeopardy." Request for Review at 9. According to BNH, "there was no evidence presented by CMS that any actions of BNH were likely to cause serious harm to a resident, or that any such harm was immediate or imminent . . . ." Id. at 2 (emphasis in original). BNH contended, moreover, that it had "introduced substantial evidence that any supposed harm was not likely, would be remote in time, and would be foiled by routine care provided by BNH and its staff." Id. (emphasis in original). BNH pointed to the testimony of its administrator, Mr. Dietz, that he did not think it likely that the care observed by the surveyors would cause an infection in any of the residents' pressure sores since "the pressure sore would have to remain untreated and that dressing left there for an extended period of time," something he said would not occur if "routine care" were provided. Id. at 10, citing Tr. at 433-434. In addition, as evidence that no infection was likely, BNH pointed to the fact that Resident 4's physician did not prescribe an antibiotic when informed of the contamination. Id. at 11-12. BNH also noted that Surveyor Wyatt had acknowledged that the "primary concern" with wounds that are infected is "interference with healing." Id. at 9, citing Tr. at 124.

Contrary to what BNH implied, CMS was not required to produce evidence other than the SOD to support its determination of immediate jeopardy here. The SOD identifies the survey findings based on which the surveyors found a deficiency under section 483.25(c) and also contains the surveyors' assessment that this deficiency posed immediate jeopardy. That assessment, and the underlying survey findings, constitute evidence supporting CMS's determination of immediate jeopardy. ⁽⁶⁾ Thus, BNH was required in response to produce evidence sufficient to demonstrate that CMS's immediate jeopardy determination was clearly erroneous.

We conclude that the ALJ properly upheld that determination since BNH failed to establish that the undisputed facts regarding the nurse's treatment of the pressure sore on Resident 4's coccyx cannot reasonably be viewed as supporting an immediate jeopardy determination. In adopting the "clearly erroneous" standard, CMS (then the Health Care Financing Administration) stated that "a provider's burden of upsetting survey findings relating to the level of noncompliance should be high" and expressed an intent that "survey team members and their supervisors" who make judgments about the level of noncompliance be accorded "some degree of flexibility, and deference, in applying their expertise . . . ." 59 Fed. Reg. 56,116, 56,178-56,179. Thus, the Board has held that a facility has a "heavy burden" to show that there is no immediate jeopardy, and has sustained a determination of immediate jeopardy where CMS presented evidence from which "[o]ne could reasonably conclude" that immediate jeopardy exists. Florence Park Care Center, DAB No. 1931, at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000).

We first address the question of whether any infection that might have resulted from the care provided to Resident 4 would have been serious. BNH relied heavily on Surveyor Wyatt's testimony that the primary effect of any infection would be "interference with healing" and that infections can generally be treated with topical antibiotics. Tr. at 123-124. BNH would apparently have us infer from this testimony that any infection that was likely to occur would not be serious since it could be easily treated. BNH also cited Clinical Practice Guideline Number 15, Treatment of Pressure Ulcers, a publication of the Agency for Health Care Quality and Research, which indicates that local infections should be treated with topical antibiotics, whereas systemic infections, which can be fatal, require treatment with systemic antibiotics. P. Ex. 9, at 8-9, 59-62. This does not establish that only an infection that requires lifesaving treatment measures can be considered serious, however. Indeed, when asked about "the primary effect on the resident of an infection in a pressure sore," Mr. Dietz testified that "[t]he wound is slow to heal" and went on to say that "I imagine it's much more - it's sorer, more pain with it." Tr. at 433. Mr. Dietz's admission that even a local infection would result in the resident experiencing "more pain" over an extended period of time undercuts, rather than supports, BNH's position. Where significant, ongoing pain is the likely result of a facility's treatment of a resident, that treatment can reasonably be viewed as placing the resident in serious jeopardy.

We further conclude that BNH did not establish that an infection was not likely to occur in the case of Resident 4. Mr. Dietz's opinion that it was not likely that BNH's care of the residents' pressure sores would cause an infection was based on the assumption that BNH would have changed a contaminated dressing in the course of providing "routine care," including "[t]he turning of a resident, incontinent care, A.M. Care, all of these things . . . ." Tr. at 433-434. It is simply speculative, however, to assume that Resident 4's contaminated dressing would have been changed as a result of routine care. BNH's former director of nursing, Ms. Arnett, testified that when the facility provided incontinent care or repositioned the resident (which occurred at least every two hours), the dressings were visually examined "to make sure they are clean and intact." Tr. at 293-294. However, a dressing change would not occur unless the dressing appeared unclean from the outside or was no longer intact. Indeed, there is no evidence that any dressing change occurred as a result of routine care after the contaminated dressing was applied to Resident 4's pressure sore. According to Mr. Dietz, the doctor's orders for Resident 4 called for the dressing to be changed once a day, which was typically done by the facility during the 7 a.m. to 3 p.m. nursing shift. Tr. at 422-423. Resident 4's treatment records show that the dressing on her pressure sore was changed twice on the day in question, once during the 7 a.m. to 3 p.m. nursing shift, and again during the 3 p.m. to 11 p.m. nursing shift. CMS Ex. 21, at 42. ⁽⁷⁾ However, it appears that the second dressing change occurred only because Surveyor Wyatt called the contamination of the pressure sore that occurred with the first dressing change to the attention of BNH's staff, who then notified Resident 4's doctor, who in turn ordered that the wound be irrigated and redressed. See ALJ Decision at 8, citing Tr. 128-129. ⁽⁸⁾ Thus, but for Surveyor Wyatt's intervention, there might have been no dressing change between the dressing change she observed and the next change pursuant to the doctor's standing order, up to 24 hours later. This could reasonably be considered the "extended time" that Mr. Dietz himself testified would permit an infection to develop, particularly since Mr. Dietz also admitted that he did not know how long it would take an infection to develop (Tr. at 434). Moreover, the fact that Resident 4's physician did not order an antibiotic does not reflect an opinion that no infection was likely to develop in the 24 hours that the contaminated dressing might have remained in place absent Surveyor Wyatt's intervention, since the physician would have expected his order to redress and irrigate the wound to be carried out sooner than that.

Finally, BNH offered no evidence that supports its position that any serious harm would be remote in time from the care in question. As evidence of the remoteness of any serious infection, BNH relied on a recommendation in the Guideline for the Treatment of Pressure Ulcers that, for an ulcer that "is not healing or continues to have exudate despite optimal care for 2 to 4 weeks, the clinician should consider a 2-week trial of topical antibiotics." Request for Review at 9, quoting BNH Ex. 9, at 5. This recommendation does not appear to apply to the situation in question here, since clearly BNH did not provide "optimal care" for Resident 4's pressure sore at the outset. In any event, even if it were not appropriate to begin the course of treatment with antibiotics until several weeks after the contamination occurred, that does not mean that the resident would not experience serious harm in the interim in the form of "more pain" as a result of the infected pressure sore.

Accordingly, we conclude that the ALJ did not err in upholding CMS's determination of immediate jeopardy based on BNH's noncompliance with section 483.25(c).

2. 42 C.F.R. � 483.65(a)(1)-(3) (Tag F-441)

Section 483.65 provides in pertinent part:

The facility must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of disease and infection.

(a) Infection control program. The facility must establish an infection control program under which it-
(1) Investigates, controls, and prevents infections in the facility;
(2) Decides what procedures, such as isolation, should be applied to an individual resident; and
(3) Maintains a record of incidents and corrective actions related to infections.

The SOD stated that BNH "failed to have an effective infection control program to ensure that the facility staff were providing pressure sore treatments utilizing accepted infection control techniques to prevent the spread of infection," referring to the incidents described above relating to Residents 4, 2 and 13. CMS Ex. 3, at 60-61. The SOD also cited numerous other incidents as evidence of the facility's failure to develop and implement an effective infection control program. In one incident, Mr. Dietz was observed handling a sheepskin sling which was contaminated with Resident 3's blood, without wearing gloves. Id. at 64. ⁽⁹⁾ In a second incident, a licensed practical nurse preparing medications for Resident 9 was observed handling the resident's gastrostomy tube connection site with ungloved hands three times without washing her hands after handling the tube. Id. at 70.

The SOD further stated:

The facility failed to ensure that all resident infections were tracked/trended through the infection control program. The facility failed to ensure that these infections were investigated for causal factors and failed to ensure that facility staff were utilizing the appropriate techniques to prevent the spread of infection.

CMS Ex. 3, at 61. Finally, the SOD stated that BNH's noncompliance with section 483.65(a)(1)-(3) "placed residents of the facility at risk for death or serious physical harm" and assessed the level of noncompliance as a pattern which posed an immediate jeopardy to resident health or safety. Id. at 60-61. ⁽¹⁰⁾ As indicated above, CMS adopted the State survey agency's findings.

The ALJ upheld CMS's determination that BNH failed to substantially comply with section 483.65(a)(1)-(3). The ALJ also upheld CMS's determination that this noncompliance posed immediate jeopardy. ALJ Decision at 29.

Below, we describe the basis on which the ALJ upheld CMS's determinations regarding the existence of the noncompliance and the immediate jeopardy. We then proceed to discuss why BNH's exceptions are without merit.

Basis for ALJ's finding of noncompliance

The ALJ concluded that BNH failed to substantially comply with the requirements of section 483.65(a)(1)-(3). ALJ Decision at 16. The ALJ determined that BNH's treatment of Residents 2, 4 and 13's pressure sores discussed above was evidence of noncompliance. ALJ Decision at 24. As evidence of noncompliance, the ALJ also pointed to "two other instances cited by CMS, the instance when Mr. Dietz handled a sling contaminated with bodily fluids and the instance when a nurse was observed to handle a resident's gastrostomy tube and administer medications without adequate precautions." Id. at 24-25. Further, the ALJ found that BNH failed to follow its own infection control policy, and concluded on that basis that BNH did not effectively implement an infection control program as required by the regulation. The ALJ stated specifically that BNH failed to compile certain data concerning each resident infection in a central location so that it could be analyzed, including the causative organisms and sources of infection, the date of infection, precautionary measures taken to halt the spread of infection, and high risk factors. Id. at 25. ⁽¹¹⁾

Basis for ALJ's finding of immediate jeopardy

The ALJ concluded that CMS's determination that BNH's noncompliance with the requirements of section 483.65(a)(1)-(3) posed immediate jeopardy was not clearly erroneous. The ALJ stated as follows:

Concerning F-441, Petitioner argues that even if there were some flaw in the Facility's overall infection control program design that would present only a risk of a delay in recognition of trends in infection. Thus, Petitioner concludes that because no harm would likely befall residents within hours, the immediate jeopardy determination was clearly erroneous. Petitioner's brief at 33. Apparently Petitioner misapprehends its burden to demonstrate the clear error of CMS's severity determination. Petitioner's supposition that no harm would likely befall residents within hours is an alternative, albeit arguably plausible, scenario for what would result from the deficient infection control program, but it is not effective to show the clear error of CMS's judgment that the deficient infection control program would likely cause more, and more prolific infections, i.e., serious harm to residents. In fact, implicit in Petitioner's argument is the apparent harm that is the concern. If the recognition of trends in infection is valuable, presumably it is so because it protects residents from the spread and worsening of infection. What precise harm to residents is presented by a delay in recognizing such trends is hard to say, but it is speculative of Petitioner to assert the delay presents so minimal a risk to residents that it shows that CMS must have been clearly erroneous to determine the delay would likely lead to serious harm. If recognition of trends [in] infection is important to infection control it is reasonable to surmise that the delay of the recognition, or the failure to apprehend a trend would likely cause serious harm to residents.

Id. at 29.

Analysis of BNH's exceptions

On appeal, BNH disputed that its failure to track all of the information specified in its infection control policy was evidence of a deficiency, asserting that "[w]here, as here, the facility policy sets a higher standard [than] the law does, failure to follow the policy is not a violation of law." Request for Review at 17, citing Lake City Extended Care Center, DAB No. 1658 (1998). In addition, BNH reiterated its argument below that, even if it failed to recognize a trend in infections as a result of a design flaw in its infection control program, any resulting harm would not pose immediate jeopardy since it "would not happen in hours or days, but over weeks or months." Id. at 20. BNH also argued in effect that there was little likelihood of any harm from inadequate implementation of its infection control policy since it had "multiple systems" in place to recognize trends in infections and had "had no outbreaks of infection, no unexplained increases, no evidence of undiagnosed infection, or any of the other results that one might expect [if] infection control was a systemic problem." Id. at 22.

We conclude that the evidence regarding BNH's failure to follow its infection control policy constitutes substantial evidence in support of the ALJ's finding of noncompliance with the requirement at section 483.65(a) for an infection control program. In Lake City Extended Care Center, the Board stated that, where a facility protocol did not reflect the applicable standard of care, the facility's failure to follow the protocol was not significant (unless the protocol was part of a care plan or was otherwise required under the regulations, which CMS did not allege was the case there). DAB No. 1658, at 11. Here, the regulation does require a facility to have an infection control program. Moreover, BNH did not establish that its policy did not reflect the applicable standard of care. BNH pointed to a 1997 article published by the Association for Professionals in Infection Control and Epidemiology, titled "Infection Prevention and Control in the Long-Term-Care Facility" (BNH Ex. 16), that "emphasizes that surveillance data should be collected from communication with staff and information in the medical record; it does not suggest that a particular form of centralized record is required." Request for Review at 16. BNH also pointed to a 2001 article from the official peer-reviewed journal of the Centers for Disease Control, Emerging Infectious Diseases (BNH Ex. 18), that "states clearly that clinical evidence does not support particular components of an infection control program in a long-term care facility." Id. at 17. However, these publications merely indicate that there is no particular infection control program that has been shown to be ideal; they do not point to a lower standard of care for infection control programs than that adopted by BNH. Thus, we see no reason why BNH should not be held to its own judgment as to what information needed to be tracked to prevent the spread of infection. Absent such information, there was a potential for more than minimal harm in the form of the spread of infection.

Even if it was not essential to track the information identified by the ALJ, moreover, there is substantial evidence to support the ALJ's finding that BNH's infection control program was deficient. Surveyor Wyatt testified that the Infection Control Resident Tracking log used by BNH (P. Ex. 10) was inadequate for infection control purposes because it was designed to track only infections that were being treated by antibiotics. Tr. at 203-204, 209-210. Thus, even if the information on the tracking log were sufficient to track infections that were being treated by antibiotics, BNH had no system for tracking other infections (e.g., viral infections for which treatment with antibiotics would not be appropriate).

Accordingly, we conclude that the ALJ properly found that BNH failed to comply substantially with the participation requirement at section 483.65(a). ⁽¹²⁾

BNH also disputed the ALJ's finding that its failure to follow its own infection control policy posed immediate jeopardy. BNH argued that, notwithstanding the omission from its tracking log of the items of information noted by the ALJ, BNH had "multiple systems" of infection control and did not experience any systemic problems with the spread of infection. Request for Review at 20-22, citing testimony of Mr. Dietz and Ms. Arnett. However, the systems described by BNH relied primarily on the tracking log and did not provide a means for tracking infections other than those being treated with antibiotics. ⁽¹³⁾ The fact that BNH was not experiencing any problem with the spread of infections at the time of the survey would not preclude a finding of immediate jeopardy since the definition of immediate jeopardy does not require actual harm, only a likelihood of serious harm.

Moreover, BNH did not establish that serious harm was not likely. It is reasonable to conclude that, in the absence of a system that tracked infections other than those being treated by antibiotics, such infections could spread unchecked, causing serious harm. Furthermore, there was a likelihood that serious harm was imminent since it is common knowledge that some types of infections can spread in a matter of days, if not sooner. ⁽¹⁴⁾

Accordingly, we conclude that the ALJ did not err in upholding CMS's determination of immediate jeopardy based on the deficiency under section 483.65(a)(1)-(3).

3. Reasonableness of the penalty amount

Finally, we reject BNH's argument that the amount of the CMP was unreasonable. The $4,050 per day CMP imposed by CMS was at the lower end of the range of CMPs that may be imposed where there is immediate jeopardy ($3,050 to $10,000 per day). The ALJ stated that BNH "challenged the immediate jeopardy determination but did not present evidence concerning the reasonableness of the amount of the immediate jeopardy civil money penalty." ALJ Decision at 30. Since BNH did not challenge the reasonableness of the CMP amount before the ALJ, that issue is not properly before the Board. See Ross Healthcare Center, DAB No. 1896, at 11 (2003) (citing the provision in the Board's Guidelines that "the Board will not consider issues not raised in the request for review, nor issues which could have been presented to the ALJ but were not").

In any event, BNH provided no justification for a reduction of the amount of the CMP. A determination concerning the reasonableness of the CMP must be guided by the factors specified in 42 C.F.R. � 488.438(f) (cross-referencing section 488.404). See CarePlex of Silver Spring, DAB No. 1683 (1999). In Coquina Center, DAB No. 1860 (2002), we stated that--

there 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. BNH argued only that "[t]he violations in question here were not serious and do not reflect systemic deficiencies." Request for Review at 22. Thus, the only regulatory factor to which BNH referred is the seriousness of the deficiencies, which includes both their severity and scope. See section 488.404(b). As discussed above, however, there is no basis for disturbing the ALJ's determination that BNH's noncompliance with sections 483.25(c) and 483.65(a) posed immediate jeopardy. In addition, it was not in our view unreasonable to impose a CMP of $4,050 per day based on the existence of two immediate jeopardy deficiencies, regardless of their scope. Moreover, even if these deficiencies warranted only the minimum penalty amount of $3,050 per day, a CMP of $4,050 per day is reasonable given the existence of the 11 other deficiencies conceded by BNH. See, e.g., Western Care Management Corp.,) d/b/a Rehab Specialties Inn, DAB No. 1921, at 86 (2004) (finding CMP for immediate jeopardy level deficiencies reasonable based on "[t]he scope (and nature) of the potential harm from that noncompliance, coupled with the numerous other non-immediate jeopardy level deficiencies . . . ").

Conclusion

For the foregoing reasons, we adopt and affirm all of the ALJ's FFCLs.

Daniel Aibel

Judith A. Ballard

Donald F. Garrett
Presiding Board Member

1. The ALJ Decision does not account for one of the 29 participation requirements, Tag F-445. See ALJ Decision at 3. We presume that the ALJ decided that it was unnecessary to address this tag.

2. A third deficiency identified in the SOD as posing immediate jeopardy, Tag F-490 (relating to administration), is not discussed in the ALJ Decision. Since this was a "derivative deficiency" based on the same facts as the two deficiencies CMS found posed immediate jeopardy (CMS Response Br. at 7), there was no reason for the ALJ to discuss it separately.

3. The record shows (but the ALJ did not note) that this was a Stage II pressure sore. CMS Ex. 21, at 42. There are four stages of pressure sores, with Stage I being the least serious and Stage IV being the most serious.

4. BNH's remaining arguments were: that the nurse's use of alcohol gel instead of soap and water to clean her hands when she ungloved while caring for Resident 4 was not evidence of noncompliance because the ALJ had no basis for assuming that the nurse's gloves were soiled; that there was no basis for a deficiency finding on the ground that the nurse caring for Resident 2 used unclean scissors to cut bandages or contaminated wipes that would be used for other residents since CMS had not proved these facts as part of its prima facie case; and that the nurse caring for Resident 13 made a reasonable nursing judgment call to complete the dressing change and do a second dressing change after the resident was cleaned up instead of having the resident cleaned up before she completed the dressing change.

5. Since this is the most egregious incident cited in the SOD under Tag F-314, the ALJ presumably had this incident in mind in reaching his conclusion regarding immediate jeopardy. It is unclear whether the ALJ determined that every incident that he identified as evidence of noncompliance with section 483.25(c) posed immediate jeopardy, however.

6. Moreover, Surveyor Wyatt testified at the State survey agency hearing that the noncompliance with respect to Resident 4 met the definition of immediate jeopardy. P. Ex. 46, at 50-54.

7. The ALJ found that, after Surveyor Wyatt ceased observing the nurse treating Resident 4's pressure sore, no nurse or another staff member returned to provide additional care. ALJ Decision at 10-11. The ALJ presumably meant that no provision was made for additional care at the time the nurse provided the care in question.

8. The ALJ Decision states that "Ms. Wyatt testified that she told Resident 4's treating physician her concerns about the Resident's dressing change and the physician ordered that Resident 4's wound be irrigated and redressed." Surveyor Wyatt testified that her conversation with the physician took place "that evening." Tr. at 128. The Surveyor Notes Worksheet prepared by her and her testimony at the State survey agency hearing both state that BNH's staff notified Resident 4's doctor of the contamination shortly after the incident in question. CMS Ex. 4, at 67; P. Ex. 46, at 32-33.

9. The sling was hanging from a trapeze bar at the foot of the resident's bed and was used to relieve pressure on his foot, which had a wound on the heel. Tr. at 174.

10. The record also includes an unsigned statement dated June 15, 2001 (during the survey) that "[t]he survey team has determined that the facility does not have an effective infection control program" and that "[i]t is the survey team's professional judgment that this situation is likely to cause the residents of this facility serious harm, impairment, or death." P. Ex. 13.

11. BNH did not dispute that this information was required by its policy.

12. BNH did not dispute that its treatment of the pressure sore on Resident 4's coccyx would be a basis for a finding of noncompliance under section 483.65(a) if it constituted noncompliance under section 483.25(c). BNH did argue that the incidents involving the failure of Mr. Dietz and a nurse to wear gloves when handling a bloodstained sheepskin sling and a gastrostomy tube, respectively, were not evidence of noncompliance under section 483.65(a). We need not address this argument since BNH raised it only to the extent necessary to avoid a finding of immediate jeopardy, and CMS's witnesses conceded that these incidents did not constitute immediate jeopardy (Tr. at 198 (testimony of Surveyor Durham) and Tr. 175 (testimony of Surveyor Wyatt)).

13. One "system" not involving the log was the monitoring of residents for signs and symptoms of infection by nurses and nurse aides. Tr. at 296-297, 447. BNH did not explain how this would enable the facility to spot trends in infections. In addition, Mr. Dietz stated that, in the course of entering physicians' orders into a computer in order to generate reports for physician signatures, he looked for other indicators of possible infections in addition to antibiotic orders (such as an order for Tylenol or a chest x-ray), and that he "would follow up . . . by checking with the Director of Nursing to see if she was aware, with the supervisor of the unit as well." Tr. at 416-417. However, it appears from this testimony that Mr. Dietz was looking only at indicators of an infection in an individual resident, not at indicators of whether a particular type of infection was spreading. Moreover, not all infections would lead to a physician's order.

14. The ALJ stated that "Petitioner's supposition that no harm would likely befall residents within hours is . . . arguably plausible" (ALJ Decision at 29); however, he did not address the likelihood of harm occurring within days, which BNH's argument conceded could be considered imminent harm.