SUBJECT: Liberty Commons Nursing and Rehab
Center -- Johnston,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Liberty Commons Nursing & Rehab Center - Johnston (Liberty Commons), a skilled nursing facility (SNF), appealed an April 20, 2005 decision by Administrative Law Judge (ALJ) Steven T. Kessel. Liberty Commons Nursing & Rehab - Johnston, DAB No. CR1294 (2005) (ALJ Decision). In that decision, the ALJ upheld two civil money penalties (CMPs) imposed by the Centers for Medicare & Medicaid Services (CMS) on Liberty Commons for alleged noncompliance with Medicare participation requirements.

One of the CMPs upheld by the ALJ was for $3,050 per day for October 22 and 23, 2003. The second CMP upheld by the ALJ was for $50 per day for the period October 23, 2003 through November 25, 2003. In this appeal, Liberty Commons objects only to the imposition of the $3,050 per day CMP, and we therefore discuss only the findings and conclusions associated with that remedy. ⁽¹⁾

[Page 2] In support of his decision to uphold the $3,050 per day CMP, the ALJ made two key conclusions. First, he concluded that on October 22 and 23, 2003, Liberty Commons was not in substantial compliance with 42 C.F.R. � 483.13(c) because it failed to implement adequately a plan to prevent a resident identified by medical history and the facility's records as being allergic to latex from being exposed to that substance. Second, the ALJ concluded that a finding by CMS that Liberty Commons' noncompliance with section 483.13(c) had placed residents in "immediate jeopardy" was not clearly erroneous. Liberty Commons challenges both of these conclusions.

As we discuss below, the ALJ's conclusion that Liberty Commons was not in substantial compliance with section 483.13(c) is legally sound and supported by substantial evidence. In addition, the ALJ correctly determined that CMS's immediate jeopardy finding was not clearly erroneous. We find, however, that the dates for which the $3,050 per day CMP should be imposed are October 21 and 22, 2003, not October 22 and 23, 2003 (as the ALJ found). Accordingly, we affirm the ALJ Decision with this one minor modification.

Case Background ⁽²⁾

A compliance survey of Liberty Commons found that on October 21, 2003, a certified nursing assistant (CNA) did not use non-latex gloves when providing care to a resident -- Resident 2 -- who, the facility believed, was allergic to latex. LC Ex. 1, at 2-7. Based on this incident, the state survey agency cited Liberty Commons for noncompliance with section 483.13(c), which requires a SNF to "develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents[.]" [Page 3] Id. In addition, the survey agency found that the noncompliance had created a situation of "immediate jeopardy." Id. at 3. CMS accepted the survey findings and imposed a $5,000 per day CMP for October 21 and 22, 2003. LC Ex. 2. Liberty Commons then requested, and received, an in-person evidentiary hearing before the ALJ to contest the survey findings.

As the ALJ noted in his decision, many relevant facts are not in dispute. Resident 2 was admitted to Liberty Commons on October 17, 2003. LC Ex. 1, at 3. His hospital discharge summary stated "Allergies: He is allergic to Latex, causing hallucinations, and respiratory problems . . . ." LC Ex. 3, at 4 (emphasis in original). ⁽³⁾ Upon admission, his family also informed the facility's staff that he was allergic to latex. Id.; ALJ Decision at 3. For a person allergic to latex, exposure to that substance can cause a reaction from mild to fatal, depending on the nature of the exposure and the person's sensitivity. ALJ Decision at 3; LC Ex. 28. Although the nursing staff had no confirmation about the degree of Resident 2's sensitivity to latex, it decided to deal with Resident 2 as if he were highly sensitive. ALJ Decision at 3. Accordingly, the staff planned to take several precautions to protect Resident 2 from latex exposure. Id. These precautions included informing the nursing staff and pharmacy of the presumed allergy, providing non-latex gloves and equipment to the staff, and posting signs in Resident 2's room warning the staff not to use latex products when providing care. Id. at 3-4.

In the early morning hours of October 21, 2003, a CNA provided care to Resident 2 while wearing latex gloves. ALJ Decision at 4; LC Ex. 1, at 4; LC Ex. 19. Shortly after, Resident 2 complained of shortness of breath. ALJ Decision at 4. When asked whether his tongue felt like it was swelling, he answered "yes." LC Ex. 14, at 2. The nursing staff promptly consulted a physician, administered oxygen to Resident 2, and transported him to the hospital. ALJ Decision at 4. He returned to Liberty [Page 4] Commons later on October 21 in (apparently) stable condition. ⁽⁴⁾ LC Ex. 14, at 3 (October 21 10:00 p.m. nursing note).

In his decision, the ALJ took note of the following additional circumstances concerning the incident:

The [CNA] who was involved in the incident did not usually work in the resident's corridor and, consequently, was unfamiliar with the resident and his presumed allergy. The precautions that Petitioner had put in place failed to forewarn the assistant about exposing the resident to latex. Warning signs that had been placed in the resident's room had been removed - possibly by the resident - so that there was no explicit visual warning in the room on October 21, 2003 to alert the staff of the dangers of using latex gloves to treat the resident. The [CNA] should have received a verbal warning at the beginning of her shift about the resident's condition. However, on October 21, 2003 the licensed practical nurse who was on duty failed to inform the [CNA] of the resident's presumed allergy. Finally, the [CNA] would have been apprised of the resident's presumed allergy had she consulted the resident's records prior to commencing her shift, because the record contained an appropriate notation. But, the nurse's assistant failed to do so, examining the resident's flow sheet only at the end of her shift.

ALJ Decision at 4 (citations omitted).

Dr. Christopher MacKinnon, Liberty Commons' medical director, testified that Resident 2's medical records, including reports of hospitalizations after the October 21^st incident (see infra footnote 3), contained "no clear evidence that the Resident ever was suffering an allergic reaction to latex or anything else." LC Ex. 31, at 2. Dr. MacKinnon stated that Resident 2 suffered from several significant respiratory ailments -- including end-stage chronic obstructive pulmonary disease (COPD) and a history of sleep apnea and aspiration pneumonia -- and that the respiratory problems he experienced on October 21 and other days [Page 5] were "probably" not caused by allergic reactions, but rather by his "underlying ailments." ⁽⁵⁾ Id. at 2-3.

Based on the documentary evidence and hearing testimony proffered by the parties, the ALJ concluded that Liberty Commons was not in substantial compliance with section 483.13(c) on October 22 and 23, 2003. ALJ Decision at 4-5. In support of that conclusion, the ALJ found that Liberty Commons had, in the following respects, been "lax in implementing its plan" to shield Resident 2 from latex exposure:

[Liberty Commons] had no effective mechanism in place to assure that an employee who was unfamiliar with Resident #2 and his presumed problem would learn about that problem and act appropriately. The nurse's assistant should have been briefed about the resident before starting the shift but was not. She should have reviewed the resident's record before providing him with care but she failed to do so. Its staff did not ensure that warning signs remained posted in the resident's room.

Id. at 4.

[Page 6] Liberty Commons argued that the October 21^st incident occurred because of an "isolated" or "single" nursing error -- one nurse who failed to communicate with one CNA -- and that it was unreasonable or improper to infer from this mistake that the nursing staff had failed to implement its policies or procedures prohibiting neglect. ALJ Decision at 5; see also LC Post-Hearing Br. at 8-12. The ALJ rejected this argument, stating that there had been a "cascade of failures" to protect Resident 2, including a failure to maintain warning signs in Resident 2's room, a failure by the supervising nurse to inform the CNA about Resident 2's allergy, and a failure by the CNA to check Resident 2's chart before providing care. ALJ Decision at 5. From these "failures" the ALJ inferred that Liberty Commons "had not drilled its staff sufficiently in the need to assure that precautions for residents who were at risk were known and carried out." Id. The ALJ added that the failures were "persuasive proof that Petitioner's problem was systemic." Id.

The ALJ then considered Liberty Commons' challenge to CMS's immediate jeopardy finding. Liberty Commons argued that there was no immediate jeopardy because there was "no clinical evidence" that Resident 2 was allergic to latex or experienced an allergic reaction on October 21, and because CMS had identified no other latex-allergic residents in the facility. Petitioner's Posthearing Br. at 12-16. Although the ALJ indicated that the evidence of Resident 2's latex allergy was "tenuous at best," he found it unnecessary to determine whether Resident 2 was in fact allergic to the substance. ALJ Decision at 6. What was important, said the ALJ, was not Resident 2's exposure or sensitivity to latex, but the "weakness of Petitioner's system for protecting its residents demonstrated by the series of errors that occurred in providing care to Resident # 2." Id. The ALJ added:

It is not unreasonable to infer from the failure of Petitioner's staff to implement the protective measures that had been developed for Resident # 2 that other residents would be jeopardized when placed in similar circumstances and that there would be a likelihood of serious injury, harm, or death as a consequence. The systemic failure to implement protective measures that was present at Petitioner's facility, as is evidenced by errors committed in providing care to Resident # 2, would jeopardize any resident who is dependent on a staff to treat him or her subject to safety precautions.

Id. at 7.

[Page 7] Finally, the ALJ found that the amount of the CMP imposed by CMS for the noncompliance was excessive because no resident had been actually harmed by the noncompliance and because CMS had not offered any proof of Liberty Commons' culpability. ALJ Decision at 9. Accordingly, the ALJ reduced the CMP from $5,000 to $3,050 per day. Id.

Liberty Commons then filed the pending appeal. ⁽⁶⁾ Liberty Commons' principal argument is that the facts found by the ALJ do not establish that its nursing staff failed to implement policies or procedures prohibiting neglect, in violation of section 483.13(c).

Standard of Review

In general, we review an ALJ decision to determine if the ALJ's findings of fact are supported by substantial evidence and its conclusions of law are correct. Guidelines - Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (at http://www.hhs.gov/dab/guidelines/prov.html); South Valley Health Care Center, DAB No. 1691, at 2 (1999), aff'd, South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10th Cir. 2000).

Discussion

A. The ALJ's conclusion that Liberty Commons was not in substantial compliance with 42 C.F.R. � 483.13(c) is legally sound and supported by substantial evidence.

Section 483.13(c) requires a SNF to "develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property." 42 C.F.R. � 483.13(c) (emphasis added). "Neglect" is defined as a "failure to provide goods and services necessary to [Page 8] avoid physical harm, mental anguish, or mental illness." ⁽⁷⁾ 42 C.F.R. � 488.301.

The ALJ concluded that Liberty Commons was not in substantial compliance with section 483.13(c) not because it had failed to "develop" policies and procedures prohibiting neglect, but because it had failed to implement such policies and procedures. When the incident in question occurred, Liberty Commons had a general policy that prohibited abuse and neglect, entitled "Abuse Prohibition Protocol." LC Ex. 27. This policy stated that Liberty Commons "will take necessary precautionary measures to prevent" neglect. Id. at 2. It also defined "neglect" as the "failure to provide goods and services necessary to avoid physical harm[.]" Id. Thus, Liberty Commons was obligated under its Abuse Prohibition Protocol to implement "precautionary measures" and provide the care necessary to keep its residents from physical harm.

In this case, it is undisputed that on October 21, 2003, Resident 2 needed -- and Liberty Commons was obligated to provide -- goods and services to avoid physical harm from exposure to latex. ⁽⁸⁾ According to the ALJ, Liberty Commons "planned" to provide such goods and services. Its planned action apparently was based on another facility policy entitled "Latex Allergy Precautions." LC Ex. 17; LC Br. at 7. The stated purpose of the Latex Allergy Precautions policy was to "minimize the risk of allergic reaction." LC Ex. 17. The policy called on the nursing staff to follow various procedures in order to identify residents with a latex allergy, communicate information about such residents among the staff, and minimize the risk that those residents would be [Page 9] exposed to latex. Because these procedures were intended to ensure that latex-allergic residents avoided physical harm, a failure to follow them constitutes a failure to implement the overall policy to prevent neglect of Liberty Commons' residents. But even apart from this particular policy statement, Liberty Commons had a duty under its general neglect policy to protect any latex allergic residents from exposure to latex.

Although the ALJ did not refer directly to the Latex Allergy Precautions policy, he did find that Liberty Commons had committed "errors" in implementing the necessary latex allergy precautions it had planned for Resident 2, some of which (such as the posting of warning signs) were provided for in that policy. Thus, it was reasonable for the ALJ to conclude that the facility had failed to implement its anti-neglect policies and procedures in violation of section 483.13(c).

Liberty Commons challenges this conclusion on several grounds. According to Liberty Commons, this case is, at bottom, about a "single failure to communicate between one nurse and one CNA." LC Br. at 14-15. Relying on prior ALJ decisions, Liberty Commons argues that a single or isolated nursing error or instance of neglect does not, by itself, establish that a facility failed to implement a policy that prohibits neglect in violation of section 483.13(c). Id. at 15-19. Liberty Commons contends that a violation of this regulation is proved only when there is evidence of a "systemic" inability or unwillingness to provide appropriate care, or when there is evidence of repeated errors or a pattern of errors that support an inference that the facility failed to implement an anti-neglect policy. Id. at 15, 18.

Liberty Commons also contends that it produced evidence, which the ALJ ignored or improperly rejected, that it had in fact implemented all necessary precautions, and that the record does not show what the ALJ termed a "cascade of errors." LC Br. at 14, 18-20. Liberty Commons asserts that there is "undisputed" evidence that once the nursing staff learned of Resident 2's allergy, it immediately took steps to implement its Latex Allergy Precautions policy. Id. at 7-8, 19. These steps included: documenting the fact of the allergy in the medical record; informing the nursing staff of the allergy and instructing them to observe latex precautions; notifying the pharmacy of the allergy; providing non-latex gloves and other items at the Resident's bedside; and posting warning signs (which contained a facsimile of a traffic "STOP" sign) at the head of Resident 2's bed, on the room's door, and elsewhere. Id. at 7-8, 14-15 (citing LC Exs. 5-6, 9-11, 18, 21-22, 30, and 32).

[Page 10] The ALJ did not accept Liberty Commons' view that the case involved a single nursing error. In fact he found "an overall failure of implementation of a plan as is evidenced by the several mistakes that were documented by CMS." ALJ Decision at 5. The "several mistakes" included: the failure of the shift nurse to notify a CNA about Resident 2's allergy before the CNA provided care; a failure to maintain posted warning signs; and a failure by the CNA to review Resident 2's medical record before she provided care to him on October 21.

Liberty Commons asserts that "there is absolutely no record evidence to support any of the supposed errors other than the failure of the charge nurse to advise the CNA to use latex precautions." LC Br. at 14. We disagree. There was, first of all, evidence that the facility had failed to consistently maintain posted warning signs in Resident 2's room. Liberty Commons' own investigation report states that a warning sign "was not in place on the night of the incident." LC Ex. 19, at 2. A handwritten statement by the charge nurse on duty at the time of the incident confirms this. LC Ex. 21. Although Liberty Commons submitted a number of handwritten statements, apparently obtained during its internal investigation, to show that the signs were posted at other times preceding the October 21, 2003 incident, see LC Exs. 20-22, ⁽⁹⁾ the incident report states that a "notice" was last seen on the 7:00 a.m. to 3:00 p.m. shift on October 19, 2003. LC Ex. 19, at 1. Moreover, to the extent the statements describe what the employees saw and where, they fall short of proving that the facility posted warning signs that adequately communicated the necessary warning. For example, one nurse stated that, on Friday October 17, she "hung a sign" indicating that Resident 2 was allergic to latex. LC Ex. 22, at 7. She did not indicate where she posted the sign, however. Nor did she indicate whether the sign contained any specific instructions for CNAs, as called for by the Latex Allergy Precautions policy. ⁽¹⁰⁾ [Page 11] In addition, the statements by this nurse and other employees conflict with statements given to surveyors by Resident 2's sister. According to the surveyors, the sister reported that she had visited the facility each day from October 17 to 20 and had seen no warning signs in Resident 2's room. LC Ex. 1, at 3; CMS Ex. 3, at 8.

In addition, the record supports the ALJ's finding that the CNA, who had never cared for Resident 2 before, erred in failing to check Resident 2's medical records before providing care. Nothing in the CNA's written statement about the incident (LC Ex. 20) indicates that she checked Resident 2's medical records before providing him care on October 21, and the facility has never asserted that she did. Notably, there is no allegation in the internal investigation report that she checked his records or otherwise sought information about the planned, required care for Resident 2. LC Ex. 19.

Liberty Commons asserts that CMS never alleged that the CNA had a duty to read Resident 2's chart, and that the "source of Judge Kessel's finding" on this issue is "unclear." LC Br. at 15. This statement does not accurately reflect the record. The Statement of Deficiencies discussed the CNA's statement that she did not look at a resident's flow sheet until after she rendered care, even though the flow sheet listed the resident's allergies. CMS Ex. 18, at 8. CMS's brief also indicates that CMS found this practice to be a flaw in the facility's process for communicating allergy issues to caregivers. CMS Br. at 5. The ALJ's finding regarding the CNA's error cites the Statement of Deficiencies' discussion of the flow sheet issue. ALJ Decision at 4.

Liberty Commons also asserts that its administrator, Beth Pate, gave unrebutted testimony that it was consistent with accepted nursing practice and the Latex Allergy Precautions policy for a licensed nurse to instruct a certified nursing assistant verbally about necessary precautions. ⁽¹¹⁾ LC Br. at 15 (citing Tr. at 95-97). However, Ms. Pate's testimony addresses only the standard of communication from the nursing supervisor to a CNA, not the [Page 12] CNA's duty of inquiry when assuming responsibility for an unfamiliar resident. Thus, her testimony does not undercut the ALJ's finding with respect to the CNA's neglect to consult Resident 2's record.

Furthermore, the regulations themselves impose a duty of communication about, and inquiry into, a resident's individual needs, including any special precautions to be followed, by requiring that care, including nursing services, be rendered in accord with resident assessments and plans of care. 42 C.F.R. �� 483.25, 483.30. Although it is not clear whether Resident 2 had gone through a comprehensive assessment process or had a written care plan by the time the CNA cared for him using latex gloves, his admission assessment form did note his allergy to latex. LC Ex. 6. Liberty Commons also "documented the fact of the Resident's latex allergy in his medical record ... ." LC Br. at 8. Under the regulations, it was Liberty Commons' duty to have a reliable system for communicating the assessment and documented medical need for latex precautions to every person providing care and services to Resident 2, by whatever means necessary to assure that they all took precautions to avoid exposing him to latex. Whether relying solely on verbal communication of a resident's special needs by the charge nurse to the CNA when a shift begins would ever be a reliable system is debatable, and certainly it proved unreliable in this case. ⁽¹²⁾ However, if such a system is used, it is necessarily flawed if it does not require a CNA who has not received the necessary information at the beginning of a shift to seek out that information, whether by asking the charge nurse about the resident's needs or, if the charge nurse is not available, by looking at the resident's chart or other records. This is especially true where, as here, a CNA has not cared for a particular resident before, and where any backup communication mechanism - such as the allergy warning signs that were supposed to be posted under Liberty Commons' allergy precaution policy - is not operational.

In short, there is substantial evidence to support the ALJ's finding that the nursing staff made at least several errors in attempting to protect Resident 2 from latex exposure. Furthermore, it was reasonable for the ALJ to infer from those [Page 13] errors that the facility had failed to implement its policies and procedures to prohibit neglect. The errors were failures to implement adequately key elements of the Latex Allergy Precautions policy, which calls on the facility to ensure that latex-allergic residents do not suffer harm from exposure to latex, as well as the facility's overall anti-neglect policy (the Abuse Prohibition Protocol), which requires the facility to "take necessary precautionary measures" to prevent neglect and defines neglect as a "failure to provide . . . services [e.g., latex precautions] necessary to avoid physical harm." LC Ex. 27, at 2.

Liberty Commons suggests that the charge nurse's failure to notify the CNA about Resident 2's allergy was simply an oversight or inadvertent error by the shift nurse and was not indicative of some larger or systemic failure of implementation. LC Br. at 15, 20. It claims, in particular, that its internal investigation found that the charge nurse "erroneously believed that the CNA had been advised that the Resident had a latex allergy and so had failed to advise her of the necessary precautions." Id. at 9. However, the written statement provided by the charge nurse during that investigation does not indicate why she failed to tell the CNA. LC Ex. 21. She indicated only that she had told Resident 2's sister that the CNA did not usually work on Resident 2's hall. Id. at 2. Furthermore, the charge nurse did not indicate that she herself knew about Resident 2's latex allergy, that she knew of her duty to inform the CNAs about the allergy, or that she had in fact given this information to all other CNAs on the shift. In addition, the facility offered no evidence that shift nurses had been trained in, or actually followed, standard procedures or practices to ensure timely and adequate communication of allergy information between nurses and CNAs, particularly CNAs who transfer from other sections of the facility or are unfamiliar with particular residents for other reasons. And although there are written statements from some nurses that they verbally informed CNAs on their shifts about Resident 2's allergy, and written statements from some CNAs that they learned this information from their charge nurses, the facility did not submit evidence confirming that all shift nurses and all CNAs who were involved in Resident 2's care between October 17 and 21 actually transmitted or received the necessary information.

Liberty Commons also provided no credible explanation for the failure to maintain posted warning signs. It says only that its nurses "believe" that Resident 2 "removed at least some of the warning signs from his room as part of his manipulative behavior pattern." LC Br. at 8 n.5, 15. However, none of the nurses or CNAs who provided declarations or statements indicated that [Page 14] Resident 2 removed warning signs or was suspected of having done so. The only evidence that Liberty Commons cites for its assertion is the unsworn statement of one nurse who indicated that Resident 2 "did tear his room apart" on Friday, October 17. Id. at 8 n.5 (citing LC Ex. 22, at 9). She did not state that Resident 2 tore down a latex precautions warning sign on October 17, and there is no indication that Resident 2 engaged in any comparable disruptive behavior between October 18 and 21.

In addition, evidence is lacking that other elements of the Latex Allergy Precautions policy were implemented in timely or consistent fashion. Item four of the policy instructs the facility to "[d]ocument the latex precautions taken," and to complete a "room prep checklist (ICP-131)." Resident 2's medical records show no documentation of any of the precautions allegedly taken by the nursing staff between October 17 and 21, 2003. The record does contain a completed "Room Preparation Checklist for Latex Allergies ICP-131" signed by Sandra McKay. LC Ex. 17, at 2. However, Ms. McKay's signature is undated, and there is no other evidence indicating when it was completed. The checklist instructs the nursing staff to perform various tasks, including removing all latex products from the room, cleaning the resident's room to remove dust containing latex allergens, posting a latex precaution sign outside the resident's door and above the bed, and stocking the room with latex free supplies needed to care for the latex-sensitive resident. Liberty Commons did not demonstrate that all of these tasks were performed or completed as soon as the facility learned of Resident 2's latex allergy or at any time prior to the October 21^st incident.

In short, the record does not verify that the facility actually followed some pre-established and commonly understood procedures for communicating information to its nursing staff, particularly its CNAs, and for implementing the measures called for in its Latex Allergy Precautions policy. The ALJ could reasonably infer under these circumstances that the errors he found were not "isolated" or inadvertent but showed a "systemic" or "overall failure of implementation" (see ALJ Decision at 5).

Liberty Commons criticizes the ALJ for reformulating CMS's "theory for the deficiency." LC Br. at 13-14. Liberty Commons asserts that although the ALJ found a "cascade of failure," CMS alleged only one failure -- a supervising nurse's "failure to brief" a CNA before the CNA provided care to Resident 2 on October -- in support of its decision to impose a CMP. Id. According to Liberty Commons, CMS's position throughout the ALJ proceeding was that the facility was noncompliant with section 483.13(c) because of this "single instance" of neglect, not [Page 15] because it failed to implement its written Latex Allergy Precautions policy. Id. at 12, 15 (citing LC Ex. 1, at 3).

This argument is meritless because CMS did in fact allege that the facility "committed a series of errors in providing care to Resident 2," including the CNA's "failure to examine the resident's record." CMS Post Hearing Br. at 5-7. The phrase "cascade of errors" can mean a continuous series or succession of errors, which is precisely what happened to expose Resident 2 to latex. See Webster's II New Riverside University Dictionary at 234 (1984 ed.). Whatever language one chooses, it is reasonable to infer, from the totality of the circumstances, that this was not a case involving an isolated error by a single employee but a "systemic" failure to implement the facility's policy or procedures to prohibit neglect.

Thus, the ALJ distinguished this case from his decision in Life Care Center of Hendersonville, DAB CR542 (1998), upon which Liberty Commons relies. See LC Br. at 16. The ALJ accurately noted that Hendersonville involved "a truly isolated error in judgment by a single employee notwithstanding the facility's best efforts to provide appropriate care." ALJ Decision at 5. In that case, the SNF presented evidence that a nurse aide's error -- a failure by the aide to use a Hoyer lift to lift a resident -- occurred even though the nursing staff had taken several steps to ensure that a policy requiring use of the lift was actually followed, such as instructing the nursing staff and posting a warning sign in the resident's room. In contrast, the evidence here showed that Liberty Commons' efforts to implement the relevant policies and procedures were, at best, incomplete or inadequate. Liberty Commons did not show that it made complete and methodical efforts to communicate information about Resident 2's allergy to staff caring for him. In addition, the nursing staff did not maintain posted warning signs in Resident 2's room, and it has not provided any credible explanation for this [Page 16] lapse. ⁽¹³⁾ Liberty Commons also failed to present evidence of relevant training.

Finally, we find no inconsistency between the ALJ's conclusion that Liberty Commons was not in substantial compliance with section 483.13(c) and similar conclusions by ALJs in other decisions upheld by the Board. In Emerald Oaks, DAB No. 1800 (2001) and Barn Hill Care Center, DAB No. 1848 (2002), the Board held that it is not error for an ALJ to infer from multiple or sufficient examples of neglect that a facility has failed to adequately implement its anti-neglect policy. In Emerald Oaks, we upheld such an inference when substantial evidence showed that the facility delayed contacting the resident's physician about sudden changes in the resident's condition and abnormal vital signs until a second episode occurred. DAB No. 1800, at 17-25. In Barn Hill, we upheld such an inference based on substantial evidence showing medication errors and untimely medication passes by one nurse on a single day. DAB No. 1848, at 8-12. Liberty Commons does not even mention Emerald Oaks, much less attempt to distinguish it. Liberty Commons does mention Barn Hill as a case in which "the DAB has adopted ... the theory that a 'cascade' of errors can support a neglect citation." LC Br. at 19 n.12. Liberty Commons then goes on to describe the 'cascade' of errors as a "series of nursing errors . . . ." Id. Thus, Liberty Commons appears to concede that Board precedent supports the ALJ here if the Board concludes, as we have, that he did not err in viewing the failures to render required care to Resident 2 as a series of errors rather than an isolated error. ⁽¹⁴⁾

[Page 17] We conclude that the ALJ reasonably inferred from Liberty Commons' exposure of Resident 2 to latex as a result of a series of errors by its nursing staff that Liberty Commons failed to adequately implement its anti-neglect policy.

B. CMS's finding of immediate jeopardy was not clearly erroneous.

Liberty Commons objects to the ALJ's conclusion that CMS's finding of immediate jeopardy was not clearly erroneous. LC Br. at 20. Immediate jeopardy is a situation in which the facility's noncompliance "has caused, or is likely to cause, serious injury, harm, impairment, or death of a resident." 42 C.F.R. � 488.301. Liberty Commons cites this regulatory definition and then cites Board cases holding that CMS has the burden of coming forward with evidence sufficient to make a prima facie case of noncompliance (the burden of production) before the provider has the burden of proving its compliance by a preponderance of the evidence (the ultimate burden of persuasion). LC Br. at 21 (citing Cross Creek Health Care Center, DAB No. 1655 (1998) and Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. DHHS, No. 98-3789 (GEB) (D.N.J. May 13, 1999)). Liberty Commons then argues that "on its face (and regardless of whether such an obligation exists otherwise as part of CMS' prima facie case) the regulation specifically requires CMS to allege and to demonstrate a causative link between some asserted noncompliance, and actual or 'likely' serious harm to one or more actual residents in order to support an immediate jeopardy finding." Id. Liberty Commons then asserts that CMS failed to establish that the noncompliance here was "likely" to cause serious injury, harm, impairment, or death because there is "no clinical evidence" that Resident 2 was, in fact, allergic to latex; because Dr. MacKinnon gave unrebutted testimony that Resident 2 probably did not have such an allergy; and because CMS produced no evidence that anyone else in the facility at the time was allergic to latex and thus might be harmed by the facility's failure to implement its latex allergy precautions. Id. at 20-25. Given these circumstances, says Liberty Commons, CMS's immediate jeopardy finding rests on a purely hypothetical or speculative threat of harm. Id. at 24.

[Page 18] Liberty Commons appears to be arguing either that CMS's burden of producing evidence sufficient to make a prima facie case on the issue of noncompliance extends to the issue of the level of noncompliance - here immediate jeopardy - as well or that CMS has the burden of proof on the issue of immediate jeopardy. Neither argument is legally supportable.

The cases cited by Liberty Commons -- Cross Creek Health Care Center and Hillman Rehabilitation Center -- state that CMS must come forth with a prima facie case on the issue of noncompliance, not on the issue of the level of noncompliance. Furthermore, the Board held in those cases, and many others, that on the issue of compliance, the provider, not CMS, has the burden of proof, by a preponderance of the evidence. See, e.g., Batavia Nursing and Convalescent Center, DAB No. 1904 (2004) (applying the Hillman analysis of the provider's burden of proof to a SNF). These cases do not address a burden of proof as to the level of noncompliance.

Extending CMS's prima facie case obligation to the issue of the level of noncompliance or allocating the burden of proof on that issue to CMS would be inconsistent with 42 C.F.R. � 498.60(c)(2), which limits the ALJ's scope of review of CMS's finding regarding the level of noncompliance. Section 498.60(c)(2) states that CMS's finding regarding the level of noncompliance "must be upheld unless it is clearly erroneous" (emphasis added). The Board has held that this regulation places the burden on the SNF -- a heavy burden, in fact -- to upset CMS's finding regarding the level of noncompliance. Barbourville Nursing Home, DAB No. 1962 (2005), aff'd Barbourville Nursing Home v. U.S. Dept. of Health and Human Servs., No. 05-3241 (6^th Cir. April 6, 2006). ⁽¹⁵⁾ In other words, under section 498.60(c)(2), CMS's finding regarding the level of noncompliance must be upheld absent a showing of clear error. To require CMS to make a prima facie case on the level of noncompliance would effectively and impermissibly convert what is clearly a limitation on the ALJ's scope of review under the regulations (and by extension a corresponding burden of [Page 19] proof on the SNF) into a burden of proof, or at least a burden of going forward, on CMS. ⁽¹⁶⁾

Turning to the merits, the ALJ did not err in concluding that the facility's noncompliance created a likelihood of serious harm regardless of whether Resident 2 was clinically allergic to latex. As the ALJ found, the validity of the immediate jeopardy finding in this case does not turn on whether there was "clinical evidence" of Resident 2's allergy to latex or whether CMS identified other residents with latex allergies. It lies, as the ALJ concluded, "in the weakness of Petitioner's system for protecting its residents demonstrated by the series of errors that occurred in providing care to Resident #2." ALJ Decision at 6. Liberty Commons undertook to care for a resident who it assumed was allergic to latex based on certain statements in his hospital records and his family's statements to facility staff. ⁽¹⁷⁾ Based on the precautions Liberty Commons admits to taking based on this information, the urgent steps it took to seek medical help for Resident 2 after it became aware of the exposure and on its Latex Allergy Precautions policy, it is evident that Liberty Commons accepted during the relevant time period that it had an obligation to protect Resident 2 from exposure to latex and that a lapse in that protection posed a very real threat of likely serious harm and even death. Whether the threat it perceived with respect to Resident 2 existed in fact is not material. Immediate jeopardy exists if a SNF's noncompliance is the type of noncompliance that would likely cause serious injury, harm, impairment, or death if not corrected, even if surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey. Hermina Traeye Memorial [Page 20] Nursing Home, DAB No. 1810, at 7 (2002), aff'd, Hermina Traeye Memorial Nursing Home v. Dep't of Health & Human Servs., No. 02-2076 (4^th Cir. Oct. 29, 2003) (noting that a "crisis situation" or a "presently existing threat" is not required for an immediate jeopardy finding); see also Royal Manor, DAB No. 1990 (2005) (finding that there was immediate jeopardy because of the "demonstrated incompetence of the facility's response" to a life-threatening emergency, incompetence that could potentially have harmed other residents with a similar medical emergency); Emerald Oaks at 23 (finding that the risk of harm must be judged by what the facility knew at the time of the incident not subsequent history or hindsight medical opinion).

Liberty Commons does not dispute the ALJ's finding that an allergic person's exposure to latex can cause a reaction ranging from mild to fatal. ALJ Decision at 3; see also LC Ex. 28, at 9 and CMS Ex. 12, at 3-4, 17-18 (describing the nature of allergic reactions, ranging from hives and nasal congestion to (in rare cases) anaphylaxis, a potentially fatal reaction). It is therefore reasonable to assume that a failure to observe or implement precautions against exposure would likely result in serious injury, harm, impairment, or death to a latex-allergic resident.

We also note that the facility's after-the-fact speculation that Resident 2 was not actually allergic to latex is nothing more than that - pure speculation. Dr. MacKinnnon, on whose testimony Liberty Commons heavily relies, did not state that Resident 2 was not allergic to latex, only that he could find "no clear evidence" that Resident 2 had ever suffered an allergic reaction, and Liberty Commons concedes that Dr. MacKinnon could not rule out that Resident 2 was allergic to latex. ⁽¹⁸⁾ LC Ex. 31, at 2; LC Br. at 12. Although Dr. MacKinnon testified that "trouble breathing and shortness of breath, without additional symptoms, is characteristic of end-stage COPD and pneumonia," LC Ex. 31, at 2, he also acknowledged that difficulty breathing, which Resident 2 complained of after his contact with the CNA on [Page 21] October 21, is one of the symptoms of an allergic reaction, Tr. at 20. Medical information submitted by the parties concerning latex allergies indicates that an allergic reaction may involve respiratory distress. See, e.g., LC Ex. 28, at 3.

In any event, the ALJ's conclusion that CMS's immediate jeopardy finding was not clearly erroneous was not based per se on the exposure of Resident 2 to latex but, rather, on what that incident reflected in terms of weaknesses in Liberty Commons' system for protecting all of its residents.

It is not unreasonable to infer from the failure of Petitioner's staff to implement the protective measures that had been developed for Resident #2 that other residents would be jeopardized when placed in similar circumstances and that there would be a likelihood of serious injury, harm or death as a consequence. The systemic failure to implement protective measures that was present at Petitioner's facility, as is evidenced by errors committed in providing care to Resident #2, would jeopardize any resident who is dependent on a staff to treat him or her subject to safety precautions.

ALJ Decision at 6. We too find this a reasonable inference. Regardless of whether there were other residents known to have latex allergies at the time, the facility had a policy and procedures for dealing with latex allergies and protecting its residents from exposure to latex. The medical record forms in evidence also indicate that the facility undertook to document in its records other allergies its residents may have had. It was not unreasonable for CMS or the ALJ to infer that Liberty Commons' failure to implement its latex allergy precautions with respect to Resident 2 evidenced a systemic laxity with respect to its allergy precautions - particularly with respect to staff communication - that posed a very real and present threat to other residents who needed protection, whether from latex in particular or other allergens.

For the reasons stated above, we agree with the ALJ's conclusion that CMS's determination that immediate jeopardy existed was not clearly erroneous.

C. Liberty Commons was not in substantial compliance with 42 C.F.R. � 483.13(c) on October 21 and 22, 2003.

Although neither party has raised this issue, it appears that the ALJ made a typographical error in identifying the dates of [Page 22] Liberty Commons' noncompliance with section 483.13(c). The ALJ concluded that this noncompliance occurred on October 22 and 23, 2003, and that Liberty Commons was subject to a $3,050 per day CMP for those two days. ALJ Decision at 1. However, in its November 17, 2003 remedy notice, CMS indicated that it had imposed the CMP for this noncompliance on October 21 and 22, 2003. LC Ex. 2. This part of CMS's remedy determination is consistent with both the substance of the ALJ's findings, which show that Liberty Commons was not in substantial compliance with section 483.13(c) on October 21 (the date of the incident involving Resident 2), and with the survey agency's Statement of Deficiencies, which shows that by October 23 Liberty Commons had completed the tasks necessary to bring itself back into substantial compliance with section 483.13(c). LC Ex. 1, at 7-12. Accordingly, we modify the ALJ Decision to reflect that Liberty Commons was not in substantial compliance with section 483.13(c) on October 21 and 22, 2003 (rather than October 22 and 23) and was therefore subject to a $3,050 per day CMP for that two-day period. This modification does not affect the amount of the CMP owed by Liberty Commons.

Conclusion

For the reasons discussed above, we affirm all of the findings of fact and conclusions of law in the ALJ Decision, except for the part that identifies the dates of noncompliance with 42 C.F.R.� 483.13(c). We modify the ALJ Decision to indicate that these dates of noncompliance were October 21 and 22, 2003.

Judith A. Ballard

Donald F. Garrett

Sheila Ann Hegy
Presiding Board Member

1. The $50 per day CMP was imposed for Liberty Commons' failure to comply with 42 C.F.R. � 483.10(e), which requires a SNF to protect the confidentiality of a resident's personal and clinical records. See ALJ Decision at 2, 8-10. Because Liberty Commons does not object to any of the ALJ's findings and conclusions that support the imposition of the $50 per day CMP, we affirm them without further discussion. See Wisteria Care Center, DAB No. 1892 (2003) (summarily affirming findings of fact and conclusions of law about which the appellant has made no argument).

2. The information in this section is drawn from the ALJ Decision and the record before the ALJ, and is presented to help the reader understand the context of the issues raised on appeal. Nothing in this section is intended to replace or supplement the ALJ's findings of fact or conclusions of law.

3. There appears to be some dispute as to when at least some of these hospital records arrived at the facility. See LC Br. at 7. However, the Liberty Commons admission form completed the day Resident 2 was admitted notes the allergy, LC Ex. 6, and the L.P.N. whose signature appears on that form later wrote that she put up a sign advising of his latex allergy on that day, LC Ex. 22, at 7. There is no dispute that the facility learned of the allergy from Resident 2's family shortly after he was admitted.

4. The next day, October 22, Resident 2 again experienced shortness of breath, and he was taken back to the hospital. LC Ex. 14, at 3-4; LC Ex. 23. He returned to Liberty Commons on October 23. LC Ex. 14, at 4. His discharge diagnoses for the October 22 hospitalization included "latex allergy" and "delayed hypersensitivity reaction." LC Ex. 23, at 1.

5. Nurse's notes indicate that Resident 2 complained of shortness of breath and difficulty breathing after his encounter with the CNA on October 21. LC Ex. 14, at 2. Dr. MacKinnon testified that "trouble breathing and shortness of breath, without additional symptoms, is characteristic of end-stage COPD and pneumonia." LC Ex. 31, at 2.

According to nurse's notes, Resident 2 said that after his contact with the CNA, he felt as if his tongue were swollen. LC Ex. 14, at 2. Dr. MacKinnon stated that a swollen tongue "definitely would be a sign of an allergic reaction" and that such a reaction "would be dramatic": according to Dr. MacKinnon, "the tongue would be obviously and grossly swollen, and would obstruct breathing and make normal speech difficult and muffled, if not impossible." LC Ex. 31, at 3. Dr. MacKinnon testified that he saw "no indication in either the nursing home nor hospital records" of this type of reaction, and that Resident 2 could have felt as if his tongue were strangling him if he had been asleep and woken up with trouble breathing because of his COPD. Id. Dr. MacKinnon noted that a severe allergic reaction would be characterized by hives, rashes, and itching, and that there were no hospital or nursing home records indicating that the resident had such signs or symptoms. Id.

6. CMS did not appeal the ALJ's reduction of the CMP.

7. CMS's Guidance to Surveyors -- Long-Term Care Facilities (CMS Guidance), an appendix to the State Operations Manual (SOM), indicates that section 483.13(c) requires SNFs to "develop and operationalize policies and procedures for screening and training employees, protection of residents and for the prevention, identification, investigation, and reporting of abuse, neglect, mistreatment, and misappropriation of property." CMS Ex. 26, at 1. The purpose of the regulation, according to the guidance, "is to assure that the facility is doing all that is within its control to prevent occurrences." Id.

8. Liberty Commons states that it "never has disputed the fact that at the time of the October 21 incident it did have the obligation to treat Resident #2 as if he did have a latex allergy (since it was not until later that questions arose in that regard)." LC Br. at 13.

9. The statements are from nurses and CNAs, including the nurse and CNA involved in the October 21^st incident, who worked in the facility between October 17, 2003 (the date of Resident 2's admission) and October 20, 2003. LC Exs. 20-22.

10. The Latex Allergy Precautions policy instructs the facility to designate appropriate precautions on a "sign" placed at the head of the bed. LC Ex. 17, at 1. The policy incorporates by reference a sample warning sign containing two prominent traffic "STOP" signs with an emphatic warning message ("Do not use or touch this resident with latex products! No latex gloves!) in large font. Id. at 1-2. None of the employees who submitted written statements gave a detailed description of the sign they had allegedly seen or posted. Some recalled seeing only a "note" in Resident 2's room. See, e.g., LC Ex. 22, at 9.

11. Although Ms. Pate is not a nurse, Tr. at 98, CMS seems not to have disputed her qualifications to address this standard.

12. We note that after this incident, as part of its plan of correction, the facility altered its system for communicating allergy information to staff by posting a roster of resident allergies at each nursing station and requiring staff to consult the roster before beginning care. LC Ex. 1, at 3.

13. Liberty Commons also cited Iredell Memorial Hospital - SNF, DAB No. CR639 (2000), Beverly Health and Rehabilitation of Williamsburg, DAB No. CR653 (2000), Pathfinder Healthcare, Inc., DAB CR958 (2002), JFK Hartwick at Edison Estates, CR840 (2001), and Ontario Care Center, DAB CR713 (2000). Iredell, Beverly, and Hartwick did not involve allegations of noncompliance with section 483.13(c). Ontario and Pathfinder involved subparts of section 483.13(c) that are not at issue here, as well as inapposite factual circumstances (e.g., staff abuse of residents and failure to investigate or report abuse).

14. Liberty Commons claims that CMS "neither offered this theory, or any evidence to support it in this case." LC Br. at 19 n.12. That statement appears to be an allusion to Liberty Commons' assumption that CMS viewed the fact pattern here as showing an isolated error rather than a series of errors, an assumption that we have already found is not supported by the record. Furthermore, CMS relied on the Board holding in Emerald Oaks that we discuss above, and also cited Barn Hill, albeit for a different point of law.

15. In Barbourville, the Board noted that when CMS adopted the "clearly erroneous" standard, CMS indicated 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 . . . .'" DAB No. 1962, at 11 (quoting 59 Fed. Reg. 56,116, 56,178-56,179).

16. The Board stated in Barbourville that CMS was not required to submit evidence other than the Statement of Deficiencies (SOD) to support its immediate jeopardy finding, noting that "the SOD identifies the survey findings based on which the surveyors found a deficiency . . . and also contains the surveyors' assessment that this deficiency posed immediate jeopardy." DAB No. 1962, at 11.

17. There is no doubt that Liberty Commons assumed Resident 2 was allergic to latex prior to the October 21^st incident and that its nursing staff understood the need to protect him from exposure to that substance as well as the potentially very serious consequences of failing to protect him. As indicated, Liberty Commons expressly concedes that it had an obligation to treat Resident 2 as if he did have a latex allergy. LC Br. at 13.

18. CMS attached a copy of Resident 2's death certificate to its appeal brief and cites to this document in discussing Dr. MacKinnon's testimony. Response Br. at 9. The ALJ had denied CMS's motion to admit this document into the record. ALJ Decision at 6 n.4. CMS did not appeal the ALJ's exclusion of the document. Neither does CMS ask the Board to admit the document into the record pursuant to 42 C.F.R. � 498.86. Because the document is not part of the record, we did not consider or rely on it in reviewing the ALJ Decision.