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                              Oak Ridge Center, DAB CR5376 (2019)
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Oak Ridge Center, DAB CR5376 (2019)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Oak Ridge Center,
	(CCN: 515174),
	Petitioner,
v.
Centers for Medicare & Medicaid Services,
	Respondent.
Docket No. C-19-241Decision No. CR5376July 17, 2019

        
              
    

      DECISION ON REMAND
I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) that Petitioner Oak Ridge Center’s noncompliance with a Medicare participation requirement, 42 C.F.R. § 483.25, comprised immediate jeopardy for residents of its facility.  I sustain CMS’s determination to impose civil money penalties against Petitioner in daily amounts of $5,900 for a period that began on September 15, 2015 and that continued through May 12, 2016.
I. Background
I issued an initial decision in this case on June 13, 2017, granting summary judgment to CMS on the issues of Petitioner’s noncompliance, the scope and severity of that noncompliance, and the reasonableness of CMS’s remedy determination.  *Oak Ridge Center,*DAB CR4865 (2017).  Petitioner appealed and an appellate panel of the Departmental Appeals Board sustained my decision in part and remanded it in part.  *Oak*
**Page 2**
*Ridge Center,*DAB No. 2913 (2018).  In its decision, the Board panel affirmed my findings of noncompliance.  *Id.* at 1-29. These findings are administratively final.
The Board panel remanded my findings that Petitioner’s noncompliance was so egregious as to comprise immediate jeopardy for residents of its facility and that CMS’s remedy determination was reasonable.  Importantly, the panel found only that there was a disputed issue of material fact as to whether Petitioner’s noncompliance amounted to immediate jeopardy level noncompliance.  It did not conclude that Petitioner was likely to prevail based on the facts and arguments that Petitioner offered.  Nor did it suggest in its decision that Petitioner’s burden at a hearing would be anything other than to satisfy the “clearly erroneous” standard set out at 42 C.F.R. § 498.60(c)(2) and that I discuss below.
I held an evidentiary hearing on April 23, 2019.  At the hearing, I limited the receipt of evidence to the issues that were before me on remand.  I received exhibits identified by CMS as CMS Ex. 1-CMS Ex. 30.  I received exhibits identified by Petitioner as P. Ex. 1-P. Ex. 32.  I ruled that portions of P. Ex. 30-P. Ex. 32 were inadmissible inasmuch as they attributed statements of fact to individuals for whom Petitioner had not provided written direct testimony.1
  Tr. at 5-6.
I also denied cross-examination of certain CMS witnesses.  These individuals are the surveyors who performed the survey on which findings of noncompliance and immediate jeopardy are based.  I excluded their cross-examination testimony because their fact findings are not at issue in this case, having been sustained by the Board’s appellate panel.  Moreover, any opinion that these surveyors might offer as to whether Petitioner’s noncompliance amounts to immediate jeopardy is irrelevant because it is a legal opinion that the surveyors are not qualified to make.  I make no findings of immediate jeopardy in this case based on surveyors’ opinions as to that issue.
**Page 3**
II. Issues, Findings of Fact and Conclusions of Law
**A. Issues**
The issues are:  whether CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.25 comprises immediate jeopardy for Petitioner’s residents was clearly erroneous; and whether CMS’s remedy determination is reasonable.
**B. Findings of Fact and Conclusions of Law**
I incorporate by reference into this decision all of the findings of fact and conclusions of law that I made in my original decision concerning Petitioner’s noncompliance.  As I have discussed, the appellate panel sustained these findings on appeal.
In my decision, I found that there were multiple and frequently repeated failures by Petitioner’s staff to carry out physicians’ orders for providing care to diabetic residents of Petitioner’s skilled nursing facility.  These failures included:  withholding insulin that physicians had prescribed for residents; failures by staff to follow Petitioner’s protocol for addressing possible episodes of hypoglycemia in residents; failures to administer prescribed long-acting insulin to one resident for a period of eight consecutive days; multiple failures (11 in total) by Petitioner’s staff to follow physicians’ orders that the physicians be notified whenever a resident’s blood sugar exceeded a specified level; and failure by Petitioner’s staff to perform a physician-ordered test measuring a resident’s blood glucose level.  *Oak Ridge Center*, DAB CR4865 at 3.
I found, and the Board appellate panel affirmed, that these failures by Petitioner’s staff were not isolated and that they amounted to a systemic failure by Petitioner’s staff to understand the dangers and risks that diabetes poses to residents of a skilled nursing facility.  I found additionally that this systemic failure had adverse consequences for residents.  Failure by Petitioner’s staff, for example, to notify a resident’s physician of that resident’s hyperglycemia resulted in the resident necessitating emergency treatment for severe hyperglycemia.  Failure by Petitioner’s staff to administer long-acting insulin to one resident for eight consecutive days caused that resident to experience multiple hyperglycemic episodes.  *Oak Ridge Center*, DAB CR4865 at 3.
CMS determined that this noncompliance amounted to immediate jeopardy for Petitioner’s residents.  Regulations define “immediate jeopardy” as being noncompliance that caused or is likely to cause serious injury, harm, impairment, or death to a resident of a skilled nursing facility.  42 C.F.R. § 488.301.
A finding of immediate jeopardy need not be predicated on a finding of actual harm to a resident.  A likelihood of serious harm, injury, impairment, or death is the minimum necessary criterion for an immediate jeopardy finding.  *Life Care Ctr. of Tullahoma*,
**Page 4**
DAB No. 2304 at 58 (2010), *aff’d, Life Care Ctr. of Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs.*, 453 F. App’x 610 (6th Cir. 2011).  Thus, CMS may predicate a finding of immediate jeopardy on noncompliance that consists of systemic failure by a facility staff to comply with participation requirements that likely will lead to serious harm in the future to residents of a skilled nursing facility even if none of the residents suffers immediate harm from the deficient conduct.
In challenging a finding of immediate jeopardy, the noncompliant facility must prove that the finding is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2).  That imposes a heavy burden on the facility, one that is greater than mere preponderance of the evidence.  A challenging facility must prove that harm or threatened harm does not meet any reasonable definition of “serious.”  *Daughters of Miriam Ctr.,*DAB No. 2192 at 9 (2007).  The Board has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *See, e.g.*,*Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (citing*Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)), *aff’d*,*Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006).  If the challenging facility does not offer evidence that excludes every reasonable ground that supports a finding of immediate jeopardy, then the finding of immediate jeopardy must be sustained.
Petitioner argues at great length that none of the residents whose care is at issue sustained serious harm or injury from Petitioner’s staff’s systemic failure to comply with physicians’ orders.  Petitioner extrapolates from that assertion to contend that if deficient conduct is not causing serious injury or harm in the immediate present, then it is unreasonable to infer that the identical conduct is likely to cause serious injury or harm if it continues.
The possibility that no resident sustained serious injury in the short run from Petitioner’s noncompliance does not answer the question of whether CMS’s determination of immediate jeopardy is clearly erroneous.  Indeed, CMS drew several conclusions from the systemic noncompliance – each leading to the finding of immediate jeopardy – that did not hinge on findings of actual harm.  Any of these conclusions, if reasonable, would support CMS’s immediate jeopardy finding.  Thus, for Petitioner to prevail, it must prove that every one of these conclusions is unreasonable based on the evidence of record.
In presenting its case, CMS relied on the testimony of an expert, Dr. Jefferson Lesesne.  CMS Ex. 29.  In his direct testimony, Dr. Lesesne stated repeatedly that Petitioner’s noncompliance put residents “at risk” of serious harm.  *Id.* at ¶¶ 40-41, 45-47, 49, 60, 62, 69.  In remanding this case to me, the Board’s appellate panel concluded that putting residents at risk of serious harm did not necessarily establish a likelihood of serious harm.  It found that Dr. Lesesne’s failure to state explicitly that Petitioner’s deficient conduct created a likelihood of serious injury or harm to residents, coupled with the rebuttal
**Page 5**
testimony offered by Petitioner’s witnesses, comprised a fact dispute as to whether Petitioner’s noncompliance constituted a likelihood of serious harm or injury for Petitioner’s residents.
A dispute of material fact that forestalls the entry of summary judgment is not enough, by itself, to bar a finding of immediate jeopardy after a hearing on the merits.  I am satisfied after reviewing the entire record that CMS had a reasonable basis – several bases, in fact – for concluding that Petitioner’s deficient conduct supported a finding of an immediate jeopardy level deficiency.
At the hearing, and in several places on the record, Dr. Lesesne resolved any ambiguity in his direct testimony by averring affirmatively that Petitioner’s deficient conduct created a likelihood of serious injury or harm to residents.  Tr. at 116, 122-24.  For example, Dr. Lesesne responded to a question by Petitioner’s counsel as to whether failure by Petitioner’s staff to follow hypoglycemia protocol created the likelihood that residents would suffer coma or death by stating:
I’m saying that failing to follow that protocol over time, there’s a likelihood that somebody’s going to have a coma or death.
Tr. at 124.
CMS found that Petitioner’s staff’s failure to follow protocol for addressing hyperglycemia and hypoglycemia created the likelihood that one or more diabetic residents would suffer serious harm or worse at some point.  CMS Ex. 29 at 6-7, ¶¶ 29-34.  The consequence of Petitioner’s staff’s failure to follow protocol was that residents’ episodes of hyper- and hypoglycemia were not identified immediately and not treated by Petitioner’s staff.  The long-term consequences of hyperglycemia include damage, dysfunction, and ultimately, organ failure, especially the kidneys, heart, brain, skin, eyes, nerves, and blood vessels.  *Id.* at 7, ¶ 31.  Hypoglycemia can cause short term consequences such as coma and death.  *Id.* ¶ 33.  I find it perfectly reasonable for CMS to have concluded from Petitioner’s staff’s systemic failures to provide care as ordered and from these long-term consequences of hyperglycemia and the consequences of hypoglycemia that residents of Petitioner’s facility manifesting hyper- and hypoglycemia likely eventually would experience serious injury, harm, or even death.  Tr. at 116.
Petitioner’s staff’s failure to follow the facility’s hypoglycemia protocol is particularly alarming.  As Dr. Lesesne testified, hypoglycemia can lead to devastating consequences in a very short period of time.  Petitioner’s protocol required its staff to perform blood sugar rechecks and other measures within strict timeframes whenever a resident’s blood sugar fell below 70.  CMS Ex. 9.  However, there were multiple instances in which residents’ blood sugar fell below 70 and Petitioner’s staff failed to record any documentation showing that they implemented the protocol.  On April 6, 2016, one
**Page 6**
resident manifested a blood sugar level of 48.  Yet, in clear violation of the hypoglycemia protocol, Petitioner’s staff failed to document any interventions.  CMS Ex. 11E at 26; P. Ex. 4 at 94.
Petitioner argues that the staff’s failure to follow hyper- and hypoglycemia protocols produced no measurable harm to any of the residents whose care is at issue.  Petitioner’s Posthearing Brief at 15-17.  That is incorrect.  As I found in my initial decision, residents were harmed by the staff’s derelictions, although that harm did not rise to the level of serious injury, harm, or death.  More important, Petitioner’s argument begs the question of whether the staff’s failure to follow applicable protocols would likely eventually result in a resident suffering serious harm.  As I have discussed, CMS’s finding that this deficient practice would likely lead to such harm is reasonable, based on evidence showing that unidentified and untreated episodes of hypoglycemia and the long-term consequences of hyperglycemia may very well produce extremely serious consequences.  It is amply supported by Dr. Lesesne’s testimony.
CMS also concluded that serious harm or injury was the likely consequence of Petitioner’s staff’s consistent failure to report episodes of residents’ hyperglycemia to the residents’ treating physicians.  CMS based this conclusion on evidence showing that episodes of hyperglycemia can result in serious injury or harm, including dehydration, lowered blood pressure, and altered mental status.  CMS Ex. 29 at 6-7, ¶¶ 29-31.
This is a reasonable conclusion.  As I have discussed, the evidence strongly supports a finding that hyperglycemia likely will have serious adverse consequences if untreated in the long run.  Staff’s frequent failures to notify physicians of residents’ hyperglycemia, despite physicians’ orders that they do so, easily supports the inference that, eventually, a resident or residents likely would be harmed seriously.
Petitioner’s attempted rebuttal to CMS’s conclusion once again points to evidence that shows that none of Petitioner’s residents suffered serious harm in the short term as a consequence of the staff’s failures to notify.  That may be so, but this evidence begs the question.  It answers only the question of whether residents were seriously harmed in the short term and does not successfully rebut CMS’s finding of a likelihood of serious harm from continued noncompliance.
Another basis for finding a likelihood of serious injury, harm, or death to Petitioner’s residents arises from its staff’s persistent and frequent failure to follow physicians’ explicit orders.  For example, staff repeatedly failed to notify physicians that residents’ blood sugar levels exceeded defined parameters, despite very clear orders that they do so.  I have discussed how blood sugar levels outside of normal ranges (hyper- or hypoglycemia) likely would eventually cause serious harm, injury, or death to residents.  But, the failure to follow orders raises issues that go beyond the diabetes-related consequences of that failure.
**Page 7**
The record offers no rationale for Petitioner’s staff failing to follow physicians’ orders other than indifference, misunderstanding, or neglect on their part.  There is no documentation in the record showing that the staff assessed residents and determined that it was not in the residents’ interest to notify treating physicians of blood sugar results that exceeded defined parameters.  There is no analysis, no discussion, nothing, from which I could infer that the nursing staff made some sort of reasoned judgment about when and under what circumstances to notify treating physicians.  Of course, even if staff had made such judgment, that would have constituted a gross violation of nursing standards of care and a dereliction of duty to residents.
It is entirely reasonable to infer that the staff’s systemic failure to follow physicians’ orders extended beyond the specific orders issued for diabetic residents.  These failures by the staff quite reasonably suggest that the staff failed wholesale to carry out its responsibilities.  That caused a likelihood of serious injury, harm, or death not just to diabetic residents of Petitioner’s facility, but additionally to all residents because it meant that the staff would likely disregard a physician’s order in circumstances other than providing diabetes care where the risk of serious injury, harm, or death, was apparent.
Carrying out the orders of a physician is an essential element of nursing.  A skilled nurse – even a highly trained one – may not disregard an order issued by a physician.  If that nurse questions the order, he or she may, and indeed should, consult with the physician. In such a consultation, the nurse may request that the order be rescinded or modified.  But under no circumstance may a nurse disregard the order. That is violation of a fundamental precept of nursing care.
Petitioner concedes that violation of a physician’s order is a breach of a nurse’s duty.  However, it argues that the staff’s violation of orders is benign in this case.  According to Petitioner, one may not extrapolate from staff’s violation of a physician’s orders that such violations, if they continue, would be likely to cause serious injury, harm, or death to a resident if those violations, individually, do no harm.
Essentially, Petitioner contends that if none of the individual violations by Petitioner’s staff caused harm, then one cannot say that there is any likelihood that future violations would cause harm.2
  That is palpably false logic.  There is no evidence to suggest that Petitioner’s staff was anything other than lucky when they disregarded physicians’ orders or committed the numerous other violations that I have found.  As I have discussed, nothing in the record of this case shows that the staff made reasoned judgments as to
**Page 8**
when to provide or withhold care or when to comply with or not to comply with physicians’ orders.  The record only shows that they failed to comply.  I note that, when interviewed by surveyors, members of Petitioner's nursing staff averred that they might withhold administration of insulin to some residents depending on how recently they had eaten or based on their blood sugar levels.  CMS Ex. 1B at 8.  There is nothing in the nursing notes or other treatment records that corroborates these assertions.  I find that they are a post hoc rationalization for failure to provide care consistent with physicians' orders.  Moreover, if the nurses thought that withholding insulin in particular instances was appropriate, they should have consulted with the residents’ physicians and requested that the orders either be modified generally or modified in the particular instance.  They failed to do so.
Petitioner’s residents were fortunate in that the staff’s tempting of fate did not harm them seriously while these violations were ongoing.  It is perfectly reasonable to infer, however, that continued noncompliance likely would eventually cause some resident or residents to suffer serious injury, harm, or death given that staff recorded no logical basis for their noncompliance.
Petitioner cites the American Medical Directors’ Association (AMDA) guidelines for diabetic care, along with two other documents consisting of that same organization’s guidelines for managing diabetes in the post-acute and long term care setting, and the American Diabetes’ Association’s criteria for managing diabetes, as proof that one could not reasonably infer that its staff’s systemic noncompliance would likely lead to serious injury, harm, or death to a resident.  *See, e.g,*Petitioner’s Posthearing Brief at 10; P. Ex. 1, P. Ex. 2; P. Ex. 3.  Petitioner’s argument is that these guidelines suggest that the variations in blood sugar experienced by Petitioner’s residents were essentially benign and that, therefore, the many failures by Petitioner’s staff to carry out orders to address blood sugar levels that were beyond parameters set by treating physicians were benign errors.
This argument fails to address CMS’s basis for finding Petitioner’s noncompliance to comprise immediate jeopardy.  I do not agree that the guidelines cited by Petitioner condone failing to address some of the blood sugar levels manifested by Petitioner’s residents.  Nothing cited by Petitioner in these guidelines suggests, for example, that a facility’s staff may systemically fail to treat a resident’s episodes of hyperglycemia without risking severe long-term damage to that resident’s health.
More importantly, I find that the guidance offered by these guidelines is irrelevant to the issue of immediate jeopardy level noncompliance.  It is irrelevant because Petitioner offered no evidence to show that its staff members were attempting to follow these guidelines or even were aware of their existence.  The possibility that blood sugars recorded by Petitioner’s residents may have coincidentally fallen into a range of variations that the guidelines suggest is not harmful says nothing about whether
**Page 9**
Petitioner’s staff were prone to committing systemic and multiple errors that likely would cause serious injury, harm, or death to residents.3
 Coincidence is no predictor of the staff’s behavior when there is no link between that behavior and what the guidelines cited by Petitioner suggest is or is not benign.
Petitioner’s arguments about guidelines amount to restating its contention that one cannot infer reasonably that the staff’s systemic violations would likely lead to serious injury, harm, or death to residents if continued because none of the violations was, in and of itself, sufficient to cause serious injury, harm, or death.  I have explained why this contention is specious.
Petitioner also relies on the testimony of three individuals who it characterizes as experts in providing care to diabetic nursing facility residents, Steven A. Levenson, M.D., Holly Estel, R.N., and Naushira Pandya, M.D.  P. Ex. 30-P. Ex. 32.  I would not find that this testimony establishes CMS’s immediate jeopardy determination to be clearly erroneous even if I accepted all of it as credible.  At most, it serves to create dueling theories as to the level of Petitioner’s noncompliance.  It does not prove Dr. Lesesne’s testimony to be incredible nor does it serve to establish that CMS’s basis for finding immediate jeopardy is clearly erroneous.  Indeed, that would be so even if I gave more weight to Petitioner’s witnesses’ testimony than I gave to Dr. Lesesne’s testimony.  As I have discussed, Petitioner’s burden here is to prove that CMS’s theories of immediate jeopardy – each of them – are unreasonable.  Providing evidence that merely weighs more heavily in Petitioner’s favor than that which CMS offers does not meet that burden of proving CMS’s determination to be unreasonable and clearly erroneous.
That said, I find the testimony of Petitioner’s witnesses to be unpersuasive in key respects.  These witnesses made assumptions about how Petitioner’s staff provided care that are not supported by the evidence.  For example, Dr. Levenson asserted that the pattern of noncompliance by Petitioner’s staff was predictably benign.  Tr. at 193-98.  But, he offered no basis for that assertion.  In fact, and as I find, there is nothing in the record of this case that shows that Petitioner’s staff was ignoring physicians’ orders only when doing so was benign.  As I have discussed, the record is devoid of evidence that the staff assessed the residents whose care is at issue, made reasoned judgments based on those assessments, and acted accordingly.  Rather, what the record shows is that the staff
**Page 10**
simply ignored physicians’ orders wholesale.  In that respect, if in none other, staff’s behavior was predictable, but it certainly was not benign.
Similarly, Dr. Levenson attempted to rationalize Petitioner’s staff’s noncompliance by asserting that the noncompliance constituted a deliberate attempt by Petitioner’s staff to withdraw or withhold treatment from residents with limited life expectancies in accord with AMDA guidelines.  P. Ex. 30 at 4-5.  That is pure conjecture on his part, unsupported by anything in the record.
Dr. Pandya contended that none of the errors committed by Petitioner’s staff caused harm to residents nor was any likely to cause serious harm.  P. Ex. 32 at 4.  But, that testimony begs the question of whether continued commission of such errors by staff would likely cause serious harm, injury, or death in the future.  Petitioner and Dr. Pandya rely on the staff’s good luck and not on anything suggesting that the staff could distinguish between a serious error and a benign one.
Dr. Pandya also speculated without evidentiary support about Petitioner’s staff’s motivation for its noncompliance.  She averred that:
In most of the cited instances, it seems more likely that the nurses’ judgments and actions – while beyond the scope of their practice – [were] actually consistent with trying to protect the subject residents from harm due to overtreatment.
P. Ex. 32 at 4.  Petitioner’s staff recorded nothing to suggest that this was their motivation for systemic noncompliance with physicians’ orders.  Petitioner offered no notes, no assessments, no addenda to care plans, nothing at all, which supports this speculation.  Furthermore, had staff been concerned about “overtreatment” of diabetic residents, as Dr. Pandya avers, they could easily have consulted with the residents’ physicians and suggested that the residents’ treatment regimes and physicians’ orders be modified.  Of course, they did not do that.
In parts of her testimony Dr. Pandya contradicted the very guidelines that she asserted served as foundation for her opinions.  For example, Dr. Pandya averred that skilled nursing facility residents always declare when they are experiencing adverse consequences from their diabetes, e.g., hyper- or hypoglycemia.  Tr. at 171.  Thus, according to Dr. Pandya, Petitioner’s staff would have known when their noncompliance led to serious consequences and would have reacted accordingly.  *Id.*This assertion is pure speculation and not credible.  It is also belied by the AMDA guidelines on which Dr. Pandya purported to rely.  The guidelines specifically state that skilled nursing facility residents “frequently are unable to perceive or communicate hypoglycemic symptoms.”  P. Ex. 1 at 9.  Symptoms of hyperglycemia are often atypical in an elderly skilled nursing facility population, and thus, not necessarily easy for staff to perceive.  *Id.*at 32.
**Page 11**
I find Ms. Estel’s testimony also to be speculative and not credible for that reason.  For example, in discussing Petitioner’s staff’s failure to administer insulin according to physicians’ orders, Ms. Estel averred that:
I understand that the affected residents’ charts show that in virtually every cited case, a physician or nurse practitioner did assess the resident, and/or did change the resident’s insulin management orders, usually within a day or two of the cited event, which implies that there must have been some communication between the nurse and physician even if the nurse did not document the consultation.
P. Ex. 31 at 2.  That assertion is pure speculation.  There is absolutely nothing in the record documenting alleged consultations between Petitioner’s staff and physicians or nurse practitioners concerning staff decisions to withhold insulin.  The record is devoid of any evidence suggesting such consultation.
Ms. Estel also suggested, without foundation, that Petitioner’s staff somehow predicated its noncompliance on each resident’s “entire clinical picture,” suggesting that the staff only disobeyed physicians’ orders when they judged their noncompliance to be in residents’ interests.  Effectively, Ms. Estel opined that the staff acted only in the residents’ best interests:
[T]his “highest practicable wellbeing” standard [in 42 C.F.R. § 483.25] requires consideration of a resident’s entire clinical picture, and the context of all the care he or she is provided, including the nature of the orders and nursing error in question, the resident’s history and overall status, current medical and nursing standards of care, and the plausible effect of the error or omission at issue.  This analysis sharpens the focus of the analysis upon effective resident care, which is the goal of the regulation.
P. Ex. 31 at 4.  However, there is nothing in the record that supports a conclusion that Petitioner’s staff ever analyzed the appropriate treatment of residents consistent with the requirements of the regulation.  All that the record shows is systemic violations of physicians’ orders and systemic failures to provide care as prescribed.  Ascribing reasoned judgment to Petitioner’s staff is pure and baseless speculation.
CMS determined to impose civil money penalties against Petitioner for its noncompliance in daily amounts of $5,900 for a period that began on September 15, 2015 and that continued through May 12, 2016.  That amount is well within the range of penalties, applicable at the time of Petitioner’s noncompliance, that CMS was authorized to impose for immediate jeopardy level regulatory violations.  42 C.F.R. § 488.438(a)(1).  Indeed, the penalty amounts are relatively modest, comprising only about one-half of the
**Page 12**
maximum penalty amount that CMS was authorized to impose for immediate jeopardy level noncompliance.
Petitioner waived the opportunity to argue that these penalty amounts, or CMS’s determination as to the duration of Petitioner’s noncompliance, were unreasonable.  There is not a word in Petitioner’s post-hearing brief challenging the reasonableness of the penalty amounts.
Nevertheless, I have considered the penalty amounts pursuant to regulatory standards and I find them to be reasonable.  Penalty amounts may be predicated on regulatory factors stated at 42 C.F.R. §§ 488.438(f)(1)-(4) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of a facility’s noncompliance.
I conclude that Petitioner’s noncompliance was extremely serious.  The evidence in this case unequivocally establishes that Petitioner’s nursing staff committed wholesale derelictions of physicians’ explicit orders.  Staff failed to communicate with physicians under circumstances where the physicians had demanded such communication.  Staff failed to carry out physicians’ instructions for administration of medication.  Staff failed to administer tests prescribed by a physician.  The implications of this noncompliance were serious, not just for Petitioner’s diabetic residents but for all of the residents of Petitioner’s facility.


          /s/
        Steven T. Kessel

                      Administrative Law Judge
      1. Petitioner argues that I should have received the excluded portions of these exhibits into evidence because they contained foundation material for its witnesses’ opinions. Admitting those excerpts into the record in the form offered by Petitioner would have been unfair to CMS because it would have denied CMS the opportunity to challenge the veracity of those excerpts. In my initial pre-hearing order, I provided Petitioner with an opportunity for it to introduce that material into evidence – either as direct evidence to support its case or as foundation material – and Petitioner failed to avail itself of that opportunity. Pre-Hearing Order ¶ 3, 7. The foundation material that Petitioner asserts that I should have received, and that I rejected, consists of recitations by Petitioner’s witnesses of what they alleged to have been told by other individuals, such as Petitioner’s director of nursing and staff. See, e.g., P. Ex. 31 at 2. Petitioner could have obtained affidavits from these individuals, offered them as evidence, and made the individuals available for CMS to cross-examine. It failed to do that. back to note 1
                      2. Paradoxically, Petitioner concedes that nurses do not have “leeway to be sloppy, or disregard orders . . . .” Petitioner’s Posthearing Brief at 11. In fact, the evidence supports a conclusion that Petitioner’s staff were sloppy and were disregarding orders. back to note 2
                      3. In fact, some of the residents’ blood sugar levels that fell outside of parameters set by physicians, and which Petitioner’s staff did not report, were beyond anything that any guideline would consider to be benign. On one occasion, Petitioner’s staff waited until a resident’s out of range blood sugar attained a level of 545 before reporting it to a physician, even though the physician had ordered that blood sugar levels above 300 be reported and despite the fact that an earlier reading of the resident’s blood sugar on that same day was 318. CMS Ex. 11A at 13. back to note 3 Back to top
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