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                              Cedar Hill Healthcare Center, DAB CR6092 (2022)
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Cedar Hill Healthcare Center, DAB CR6092 (2022)








  
  
    

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





Cedar Hill Healthcare Center,
(CCN: 675032),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-585Decision No. CR6092June 7, 2022

        
              
    

      DECISION

I sustain the determinations of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, Cedar Hill Healthcare Center, a skilled nursing facility that does business in Texas.  The remedies that I sustain are:

A civil money penalty of $15,975 for each day of a period that began on October 20, 2020, and that ran through October 27, 2020;
	A civil money penalty of $435 for each day of a period that began on October 28, 2020, and that ran through November 24, 2020;
	A civil money penalty of $225 for each day of a period that began on November 2, 2020, and that ran through December 1, 2020;
	Denial of payment for new Medicare admissions for each day of a period that began on November 25, 2020, and that ran through December 1, 2020; and
	A directed plan of correction.Page 2

I. Background

CMS moved for summary judgment.  I denied the motion, finding disputed issues of material fact.  I held an in-person hearing on February 17, 2022.

CMS offered 20 exhibits, identified as CMS Ex. 1-CMS Ex. 20.  Petitioner filed 14 exhibits, identified as P. Ex. 1-P. Ex. 14.  It filed an additional exhibit that it identified as P. Ex. A.  I overruled the parties' objections to my receiving certain exhibits and received all of them, with the exception of P. Ex. A, into evidence.1

II. Issues, Findings of Fact and Conclusions of Law

**A. Issues**

Remedies in this case address Petitioner's failure to comply with two Medicare participation requirements, set forth at 42 C.F.R. §§ 483.80(a)(1) and 483.45(f)(2).  The issues are whether Petitioner failed to comply substantially with Medicare participation requirements, whether Petitioner's noncompliance with one of these requirements, 42 C.F.R. § 483.80(a)(1), was so egregious as to comprise immediate jeopardy for Petitioner's residents, and whether CMS's remedy determinations are reasonable.

**B. Findings of Fact and Conclusions of Law**

I find that Petitioner failed to enforce its own infection prevention and control plan that it implemented to protect its residents against infection with the virus known as Covid-19 (Covid), because it failed to screen its staff consistently and thoroughly for signs of the virus.  That failure resulted in staff who were infected with Covid working at Petitioner's facility and putting residents at risk for becoming infected.

I find also that Petitioner's staff failed to follow a physician's order to administer a prescribed dose of an anticoagulant drug, Eliquis, resulting in a resident not receiving the prescribed dosage for an extended period.

**Petitioner's Compliance Duty**Petitioner must comply with the regulations set forth at 42 C.F.R. Part 483 to participate in Medicare.  The regulations establish a "substantial compliance" criterion for compliance.  A facility must satisfy all requirements to the extent that any identified

Page 3

compliance deficiencies pose no greater risk to resident health or safety than the risk of minimal harm.  42 C.F.R. § 488.301.

Petitioner initially argued that the "pivotal" issues in this case related to whether Petitioner's actions were "reasonable" or "appropriate" under certain circumstances.  Petitioner's Response to CMS's Motion for Summary Judgment (Petitioner's Response) at 2-3.2
  It contended that this case (and by extension all cases involving compliance with participation requirements) hinges on whether the facility's conduct was "reasonable."  It cited no decisions involving the administration of the Medicare program to support this legal theory, nor did it explain how this theory addresses the substantial compliance test established by regulations.

At the hearing I advised the parties that I rejected this legal theory because it comprises an attempt, without basis in law, to incorporate a tort standard of liability into enforcement of participation requirements.  The criteria for compliance are established by regulation and may not be interpreted through the lens of common-law tort principles.  *Heritage House of Marshall Health & Rehab.*, DAB No. 3035 at 9 (2021).  In addressing the issue of noncompliance, I must answer the following questions:  (1) did action or inaction by a facility violate regulatory requirements; and (2) if so, did the violation pose a risk to resident health or safety that is greater than minimal harm.

Petitioner changed its theory of its compliance obligations in its post-hearing brief.  Now, Petitioner contends that it has no compliance duty where regulations do not explicitly define that duty.  Petitioner's Post-Hearing Brief at 3-4.  It makes this assertion in opposition to CMS's allegations that Petitioner did not comply with regulatory requirements governing infection control.  I address Petitioner's argument in detail below.

**Noncompliance with 42 C.F.R. § 483.80(a)(1)(2)**The setting for CMS's noncompliance allegation is the Covid-19 (Covid) pandemic that has beset this country and the world since early 2020.  I take notice that Covid is a highly infectious respiratory virus that may be lethal, especially with individuals who are aged or infirm.

There is near certainty that Covid infection within a skilled nursing facility will result in grave illnesses and residents' deaths.  Covid has been a death sentence for many

Page 4

thousands of nursing home residents.  "Nearly One-Third of U.S. Coronavirus Deaths are Linked to Nursing Homes," *New York Times,* June 21, 2021.  That imposes a very heavy burden on a facility to adopt stringent infection prevention and control policies that address Covid and to enforce those standards scrupulously, even rigidly.  Failure by a facility to comply with its Covid prevention and protection policies poses a risk of harm to residents.3

A skilled nursing facility must establish and implement an infection prevention and control plan that complies with accepted national standards.  42 C.F.R. § 483.80.  As an element of its infection control program, a facility must, among other things, establish a system for:

[P]reventing, identifying, reporting, investigating, and controlling infections and communicable diseases . . . .

42 C.F.R. § 483.80(a)(1).  This requirement applies to staff, residents, visitors, and individuals working for a facility as contractors.

The regulation in effect as of the dates of Petitioner's alleged noncompliance did not state specific actions that a facility must take to protect its residents against infection with Covid.  Petitioner interprets that lack of specificity to mean that the regulation is unenforceable in the context of Covid infection control:

[A]bsent a specific, on-point regulation setting forth a COVID-19 testing or screening protocol, which Petitioner failed to follow, then there is no basis for CMS to take enforcement action.

Petitioner's Post-Hearing Brief at 4.  Petitioner goes further to argue that CMS may not challenge Petitioner's failure to enforce its infection control policies because it was under no regulatory obligation to draft or implement policies, absent some explicit regulatory directive.  Petitioner's Post-Hearing Brief at 8.  Petitioner would have it that it could simply ignore the dangers posed by Covid entering its facility or could flagrantly violate its own infection control policies and CMS would be powerless to charge Petitioner with violation of the infection control regulation because the regulation doesn't specifically define what a facility must implement in the context of a Covid infection.

This argument is wrong as a matter of law.  The fact that the infection control regulation then in effect did not explicitly refer to Covid did not excuse Petitioner from doing its

Page 5

utmost to protect against the disease.  Covid is an infectious illness, and the regulation explicitly applies to all infectious illnesses.

The regulation's broadly worded language gives a facility some discretion in the way it may design and implement its Covid prevention program.  But that program must comport with accepted national standards for infection control, and it must be implemented by the facility.  A facility is noncompliant if it fails to develop an effective policy or if it fails to implement its policy.  Given the infectiousness of Covid and its likely lethal consequences for many infected residents of skilled nursing facilities, a facility must do its utmost to prevent infection to comply with the infection control regulation's requirements.  Failure by a facility to implement its own infection control policies to prevent the introduction of Covid into its premises constitutes an obvious regulatory violation.

The infection control regulation governs the control of infections in general and not just Covid.  It implicitly accepts that no two skilled nursing facilities are designed, laid out, and staffed exactly alike, and for that reason, it establishes general standards that a facility must follow rather than providing a laundry list of explicit actions.

However, the regulation's general requirements are not vague and its prescriptions of what a facility must do to implement an infection control program do not render it unenforceable in the context of Covid.  The regulation describes in considerable detail the systems and measures that a skilled nursing facility must adopt as its infection control protocol.  42 C.F.R. § 483.80(a)(1)(2).  It directs a skilled nursing facility to develop and implement a system of surveillance that is designed to identify possible communicable diseases or infections before they can spread to other persons in the facility.  42 C.F.R. § 483.80(a)(2)(i).  The facility must also identify when and to whom possible incidences of communicable disease or infection must be reported.  42 C.F.R. § 483.80(a)(2)(ii).  Any system that the facility adopts must comport with accepted national standards.

The evidence establishes that Petitioner adopted an infection control program for Covid that included rigorous screening requirements to assure that infected staff and other persons did not enter Petitioner's premises.  CMS does not challenge the specifics of that policy nor does CMS allege that Petitioner's policy failed to comport with accepted national standards for protection against Covid infection.  CMS's case centers around Petitioner's failure to implement its policy.  Specifically, CMS asserts that on more than one occasion Petitioner allowed potentially infected individuals to enter its premises without screening those individuals in violation of its own Covid infection control protocol.

The evidence strongly supports CMS's allegations.  Petitioner failed to enforce its own policies more than once, allowing individuals who, in at least one instance were infected

Page 6

with Covid, to enter its premises, thereby creating pathways for the spread of this potentially lethal disease to residents and staff.

Petitioner's Covid prevention and control policy required Petitioner's infection preventionist and/or designee to monitor any ill healthcare personnel.  It required staff who developed a fever and respiratory symptoms to be "screened out" of the facility, meaning excluded from working.  CMS Ex. 8 at 7-9.  The policy directed staff to self‐assess for symptoms of illness, including temperature monitoring, and to record their results each time they reported for work on a document that Petitioner referred to as a "screening tool."  *Id.*  The policy also required staff to be tested at prescribed intervals for Covid infection.  *Id.*

The Covid prevention and control policy relied heavily on self-reporting by staff members and contractors.  Failure by a staff member or a contractor to check his or her temperature and to record it and/or to report Covid symptoms left a hole in the reporting system.

The policy's dependence on self-reporting required the screening tool to be scrupulously reviewed by Petitioner's infection preventionist or designee just as soon as staff members and contractors reported to work.  The reviewer not only had to look for possible signs of infection among staff and contractors, but also had to make sure that everyone on duty carefully recorded his or her temperatures and symptoms.  Any failure by staff to report their temperatures and symptoms meant that potentially infected individuals might enter Petitioner's premises undetected.  Likewise, any failure to review the screening tool promptly and carefully meant that an infected employee or contractor might slip through the cracks and work in direct contact with residents – with potentially lethal consequences for those residents.

Tambra Mason is a certified nursing assistant and was a member of Petitioner's staff in October 2020.  Ms. Mason did not work the overnight shift ending the morning of October 16 because she felt ill – her chest hurt, she had body pain, and she ran a temperature.  CMS Ex. 7 at 18-19.  Notwithstanding, she reported to work for the shifts ending the mornings of October 17, 18, and 19, 2020.  CMS Ex. 4 at 1-61; CMS Ex. 5 at 7; CMS Ex. 7 at 18-19; CMS Ex. 9 at 8.

The most minimal investigation of Ms. Mason's condition by Petitioner's management would have revealed that she was not qualified to report to work and that she should have been sent home immediately on the evening of October 16.  Ms. Mason admitted that she had a fever on October 15-16, sufficient to keep her out of work.  Petitioner's policy states that a staff member experiencing fever must not work for at least 72 hours after his or her fever abates.  CMS Ex. 8 at 7-9.

Page 7

Petitioner's failure to exclude Ms. Mason from working resulted in a Covid-positive member of the staff working in close contact with Petitioner's vulnerable residents.  Ms. Mason was infected with Covid on October 16, 17 and 18, 2020.  CMS Ex. 2 at 5.  A Covid test that Ms. Mason took on October 16, 2020, was positive.  *Id.*

The failure involving Ms. Mason was not isolated or unique to her.  Petitioner failed in other instances to screen its employees according to its own policy and at least one other individual worked at Petitioner's facility while possibly positive for Covid.

Anthony Rice was a contractor who worked as a housekeeping supervisor at Petitioner's facility in October 2020.  Mr. Rice worked every day beginning October 12 through October 18, 2020.  CMS Ex. 7 at 19.  Mr. Rice did not fill out the screening tool during this period.  His name does not show up on Petitioner's staff temperature log.  CMS Ex. 5.  A charge nurse averred that Mr. Rice was exempt from making entries because he worked for a contracting agency.  CMS Ex. 7 at 17.  This assertion is wrong: Petitioner's Covid policy required contract personnel to undergo the same screening process as employees.  CMS Ex. 8 at 10.

Petitioner's policy mandated that Mr. Rice be tested for Covid on October 13 and 16, 2020 (a Tuesday and a Friday).  CMS Ex. 7 at 19.  However, Petitioner had no documentation that Mr. Rice was tested on the 13th of October.  He was tested on the 16th.  On October 19, 2020, Petitioner learned that Mr. Rice had tested positive for Covid.  One cannot determine whether Mr. Rice was infected on the 13th through the 15th of October, due to the failure to test him on the 13th.  Petitioner's failure to test Mr. Rice on October 13 was a plain violation of its policy that created at least the possibility that he worked for several days while infected.

There was an additional instance in which Petitioner failed to screen a member of its staff consistent with the requirements of its Covid prevention and control policy.  Jaquanda Williams is a certified nursing assistant who was sent by a staffing agency to work at Petitioner's facility.  Ms. Williams worked a shift at Petitioner's facility on October 17, 2020.  CMS Ex. 7 at 18; CMS Ex. 5 at 1.  She was not tested for Covid prior to commencing work at Petitioner's facility.  CMS Ex. 7 at 18.  Ms. Williams did not enter her temperature on Petitioner's screening tool (temperature log) on October 17.  CMS Ex. 5 at 9-10.

I find Petitioner's arguments to be without merit.

Petitioner relies on the testimony of Olufunke Adewoyin, LVN, as evidence that Petitioner's staff properly screened Ms. Mason on the evening of October 16, 2020, when Ms. Mason reported to work.  P. Ex. 10.  Ms. Adewoyin avers that she personally observed an unnamed individual – the night shift charge nurse – check Ms. Mason's temperature and found it to be 97.8 degrees Fahrenheit.  She avers also that the charge

Page 8

nurse asked Ms. Mason the appropriate screening questions and that Ms. Mason indicated that she was feeling well without symptoms of Covid.  *Id.*

However, Petitioner's policy required that Ms. Mason be excused from work even if her temperature was normal on the evening of October 16, 2020 and even if she displayed no symptoms of Covid on that date.  Ms. Mason's fever and illness on the previous day precluded her from working for 72 hours pursuant to Petitioner's policy.  CMS Ex. 8 at 7-9.

Moreover, I find Ms. Adewoyin's testimony not to be credible.  Petitioner has offered nothing to corroborate it:  no testimony by the charge nurse who Petitioner alleges screened Ms. Mason on October 16, 2020, and no records showing that a screening tool was completed by Ms. Mason on that date.

One of Petitioner's nurses, Lee Anne Jordan, states in a declaration that she worked with Ms. Mason and that Ms. Mason never exhibited signs of illness and did not appear to be running a fever.  P. Ex. 11.  According to Ms. Jordan, Ms. Mason always appeared to be illness-free, including during the overnight shift of October 16-17, 2020, when Ms. Jordan worked as a charge nurse.  *Id.*  As I have found, Ms. Mason stayed home ill for the overnight shift on October 15-16, when she exhibited signs of Covid, including a fever.

The fact that Ms. Mason may not have openly exhibited signs or symptoms of Covid when she worked the overnight shift on October 16-17, 2020, provides Petitioner with no defense.  Ms. Mason was symptomatic the previous day, so much so that she stayed home from work due to illness.  Petitioner's policy directed that Ms. Mason not be permitted into the facility for the overnight shift on October 16-17, 2020, due to her feverish condition the previous day.

Concerning Mr. Rice, Petitioner contends that he was resistant to being tested and was noncompliant with screening procedures, so much so that Petitioner eventually severed its relationship with him.  Petitioner's Response at 7.  Petitioner contends also that its management immediately sent Mr. Rice home on October 19, 2020, when they learned that he had tested positive for Covid.  Petitioner's Response at 7-8; Petitioner's Post-Hearing Brief at 7.  That does not answer CMS's allegations about the way Petitioner dealt with Mr. Rice.  The unrebutted evidence offered by CMS establishes that Petitioner did not require Mr. Rice to fill out a screening form and did not test him for Covid on October 13, 2020.  These failures violated Petitioner's infection control policy.

Petitioner offered neither evidence nor argument addressing its failure to require Ms. Williams to obtain a pre-employment test for Covid or its failure to screen Ms. Williams on October 17, 2020.

Page 9

Petitioner asserts that its actions and inactions must be evaluated in the context of the allegedly daunting tasks facing skilled nursing facilities in the autumn of 2020.  Petitioner's Response at 4-5.  It recites that it had difficulties finding and retaining staff and obtaining adequate supplies of personal protective equipment such as masks and gowns.  It argues that it experienced difficulty obtaining quick results for the Covid tests that it administered to its employees (PCR tests).  It argues that it was not required to employ faster antigen tests to determine whether employees were positive for Covid.  *Id.*

These assertions are irrelevant.  CMS has not alleged, nor do I find, that Petitioner was inadequately staffed, that it failed to provide its staff with sufficient quantities of personal protective equipment, or that it used the wrong tests to determine whether staff members were Covid-positive.  Indeed, CMS has not alleged, and I do not find, that Petitioner was deficient because it failed to obtain test results more quickly.  The center of CMS's case and my noncompliance findings is that Petitioner failed to screen its employees pursuant to its own policy.  It allowed possibly infected staff to work without filling out required forms, failed to review those forms timely, and allowed a staff member to work the day after she had reported ill with a fever.  These findings have absolutely nothing to do with the daunting tasks that Petitioner contends it had to perform.

Petitioner argues that it did not allow staff manifesting Covid symptoms to work under any circumstances, contending that Ms. Mason did not exhibit Covid signs or symptoms.  Petitioner's Response at 6.  That assertion – even if true – fails to address the fact that Petitioner permitted Ms. Mason to work in obvious violation of Petitioner's policy the day after she stayed home ill with a fever.

Petitioner extols the policy it asserts it had in place to track staff testing, screen staff prior to entering its facility, and to ensure staff who tested positive for Covid or who displayed Covid symptoms were not allowed to work.  It mischaracterizes CMS's allegations by claiming that CMS is asserting that Petitioner had an inadequate infection control policy.  Petitioner's Response at 6-7.  However, CMS does not premise its allegations on an assertion that Petitioner had a defective infection prevention and control policy, and I do not find that Petitioner's policy was defective.  This case centers around Petitioner's failure to implement its policy.  There would be no basis for finding Petitioner to be noncompliant if it had implemented its policy.

Similarly, Petitioner asserts that CMS contends that Petitioner allowed Ms. Mason to work while symptomatic with Covid.  Petitioner's Post-Hearing Brief at 9-10.  However, CMS is not alleging that Petitioner violated its infection control policy by allowing Ms. Mason to work when she was symptomatic.  It alleges – and the evidence establishes conclusively – that Petitioner allowed Ms. Mason to work even though she ran a fever on the day prior to her return, a blatant violation of Petitioner's infection control policy.  Whether she was symptomatic on October 16, 2020, is irrelevant because she ran a fever and felt ill on the previous day.

Page 10

Petitioner contends that on the dates at issue in this case it was facing staffing challenges relating to the Covid pandemic and other "ancillary issues."  Petitioner's Post-Hearing Brief at 11-12.  Whether that is so affords Petitioner no excuse for its failure to implement its Covid prevention policy.  Petitioner has not made any case to show that staffing issues rendered its policy impossible to implement.  Petitioner's policy relied heavily on self-reporting by employees.  It assigned one individual to the task of screening employees as they entered the facility.  CMS Ex. 8 at 7-9.  Petitioner offered no evidence to show that it lacked the manpower to perform that function, whatever other staffing issues it may have had.

Petitioner argues that CMS's "primary allegation" is that Petitioner failed to follow testing procedures as required by county testing requirements.  Petitioner's Post-Hearing Brief at 13-14.  It argues that, in fact, the frequency with which it tested its staff for Covid was consistent with local requirements.  *Id.*

Frequency of testing in compliance with county standards is not an element of CMS's case.  CMS did not address this question in either its motion for summary judgment or in its post-hearing brief.  *See* Respondent's Motion for Summary Judgment at 11-15; Respondent's Post-Hearing Brief at 2-7.  Rather, Petitioner's failure to test its staff consistent with the requirements of its own policy is an element of its noncompliance.  That testing policy rests independent from whatever county policies may have been in effect at the time.4

It is no defense for Petitioner to argue that it should be let off the hook for failure to comply with its own policy because the local government may have had a testing policy that was less stringent than what Petitioner required.  Petitioner developed its policy based on the perceived needs of its residents and based also on the immense danger that Covid posed to these residents.  Having developed that policy, Petitioner was bound to implement it.  If Petitioner wanted to amend or alter that policy considering changed conditions, it might have done so based on a rational assessment of how those conditions had changed.  There is zero evidence that Petitioner did so here, only evidence that it was remiss in enforcing the policy that it had adopted.

Indeed, Petitioner touts its own policy mandating twice weekly testing, asserting that it exceeded county requirements.  Petitioner's Post-Hearing Brief at 13.  Its assertion that it is held unfairly to a policy that required testing more stringently than local county requirements is clearly inconsistent with its assertion that its staff testing requirement was superior to that which the county required.

Page 11

CMS found that Petitioner's noncompliance with the infection control regulation was so egregious as to put residents of the facility in a state of immediate jeopardy.

Regulations define immediate jeopardy as noncompliance that causes, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  The burden falls on a facility to prove that a finding of immediate jeopardy level noncompliance is clearly erroneous where noncompliance is established, as is the case here.  42 C.F.R. § 498.60(c)(2); *Liberty Commons Nursing & Rehab. Ctr.-Johnston*, DAB No. 2031 at 18-19 (2006), *aff'd, Liberty Commons Nursing & Rehab. Ctr.-Johnston v. Leavitt*, 241 F. App'x 76 (4th Cir. 2007).

Petitioner did not prove that CMS's finding of immediate jeopardy level noncompliance is clearly erroneous.  Indeed, there is overwhelming evidence of a likelihood of harm or death to residents of Petitioner's facility from Petitioner's failure to enforce its Covid protection policy.  As I have discussed, Covid has taken a frightful toll on nursing facility residents in this country.  Many thousands of elderly and infirm nursing facility residents have died from this disease.  Failure to enforce a policy to protect against introduction of Covid into a facility may well be a death sentence for some residents.

Petitioner denies that it failed to comply with the infection control requirement but asserts that if it did, there is no evidence that its failure caused any resident to become infected.  That may be so, but actual harm is not a necessary element of a finding of immediate jeopardy level noncompliance.  As I have explained, a likelihood of serious injury, harm, impairment, or death is a component of immediate jeopardy, a likelihood that clearly existed here given that Petitioner, by failing to screen its staff, allowed at least one Covid-positive individual to work on its premises.

Petitioner asserts also that the criteria for determining immediate jeopardy places a "much higher burden" on state agency surveyors seeking to uphold a determination of immediate jeopardy.  Petitioner's Post-Hearing Brief at 17.  Petitioner has the burden exactly wrong; the burden lies on Petitioner to prove that a finding of immediate jeopardy is clearly erroneous.

Petitioner also alleges that there was no need for immediate corrective action to remedy its noncompliance.  Petitioner's Post-Hearing Brief at 17.  Petitioner's rationale is that it did nothing to violate the regulation, therefore there was nothing for it to fix.  The evidence in this case belies that assertion.  The need for corrective action is manifest in the finding of immediate jeopardy.  Indeed, CMS determined that immediate jeopardy persisted at Petitioner's facility for eight days until Petitioner made necessary corrections in implementing its infection control policy.

Page 12

**Noncompliance with 42 C.F.R. § 483.45(f)(2)**A skilled nursing facility must ensure that its residents are free from significant medication errors.  42 C.F.R. § 483.45(f)(2).  CMS alleges that Petitioner contravened a physician's order by consistently failing to administer a medication to a resident as per the prescription for that medication.

The evidence plainly supports CMS's contention.  I find that the failure by Petitioner's staff to carry out a physician's order to administer medication to a resident posed a potential for more than minimal harm to one of Petitioner's residents and therefore was a regulatory violation.  *See* 42 C.F.R. § 488.301.

Petitioner had a policy governing administration of medication.  It stated that medication shall be administered in a safe and timely manner and as prescribed and administered pursuant to orders.  CMS Ex. 17 at 1.  Petitioner's staff failed to follow this policy in administering medication to a resident, identified as Resident 1.

Resident 1 suffered from several serious medical conditions.  She had experienced a stroke and had atrial fibrillation.  CMS Ex. 12 at 2.  The resident was at risk for having life-threatening blood clots.  *See* Transcript at 56.  Clearly cognizant of this risk, the resident's physician prescribed an anticoagulant medication, Eliquis, to be administered to the resident in a dose of 2.5 mg, twice daily.  Despite this order, Petitioner's staff administered Eliquis to Resident 1 only once daily for at least 125 days.  CMS Ex. 12 at 3; CMS Ex. 13 at 1; CMS Ex. 14 at 17; CMS Ex. 16 at 12.  Upon discovery of this error and after having been notified, the physician reduced the resident's prescription for Eliquis to require administration once daily.  CMS Ex. 16 at 5.

The evidence establishes a gross failure by Petitioner's staff to administer a potentially life-protecting medication in accord with a physician's order.  The potential for harm arises directly from the risk of harm imposed on Resident 1 from the carelessness of the staff.  The staff's consistent error proves that Petitioner's staff failed to exercise its duty of care to assure that medications be administered precisely as ordered.

The potential for harm posed to Resident 1 from the staff's misadministration of medication is, in and of itself, sufficient to find noncompliance.  However, it is also reasonable to generalize from the failure in Resident 1's case to conclude that this staff was not mindful of its duty to be scrupulous in the administration of medication.  That potentially put all of Petitioner's residents at risk for harm from erroneous medication administration.

In its defense, Petitioner asserts: no harm, no foul.  It argues that the fact that Resident 1's physician reduced the dose of Eliquis to Resident 1 after the staff's administration error

Page 13

was revealed means that there was never the potential for harm in giving Resident 1 less medication than was prescribed.  Petitioner's Post-Hearing Brief at 19.

However, the evidence doesn't support this assertion.  There is no testimony of record from Resident 1's physician addressing why he/she prescribed Eliquis twice daily to begin with and why he/she reduced the prescribed dose subsequently.  It is reasonable to infer that the physician originally prescribed 2.5 mg of the medication twice per‐day because he/she concluded that the resident needed that dose.  The physician may have concluded that the resident no longer needed that dose after several months had transpired but that doesn't mean that he/she concluded that the resident did not need it to begin with and that the original prescription was for too much medication.

Petitioner contends that: "it is clear that the physician and interdisciplinary team documented and agreed that the resident's atrial fibrillation was well controlled on the once daily 2.5mg Eliquis dose."  Petitioner's Post-Hearing Brief at 19.  Petitioner's contention is unsupported by the evidence.

As support for this assertion Petitioner cites to P. Ex. 8.  The exhibit is a report of an interdisciplinary conference dated June 12, 2020, months prior to the finding that Eliquis was being incorrectly administered to Resident 1.  There is no discussion in the document concerning the amount of Eliquis that Resident 1 was receiving.  The only statement in the document that refers to Eliquis is a statement that the resident's atrial fibrillation was managed with Eliquis.  *See* P. Ex. 8.  One cannot infer from this document that the physician knew that the resident was receiving only one half of the dose of Eliquis that he/she had prescribed.

Petitioner argues that the only legitimate question that one may ask about its staff's misadministration of medication is whether the misadministration of Eliquis to Resident 1 caused her to experience discomfort or harm.  Petitioner's Post-Hearing Brief at 20.  That mischaracterizes the law.  While discomfort or harm resulting from error is certainly a basis for finding noncompliance so is the potential that a resident may suffer from significant harm.  That potential is evident here.

**Remedies**CMS imposed the following remedies against Petitioner:

A civil money penalty of $15,975 for each day of a period that began on October 20, 2020, and that ran through October 27, 2020;
	A civil money penalty of $435 for each day of a period that began on October 28, 2020, and that ran through November 24, 2020;Page 14

A civil money penalty of $225 for each day of a period that began on November 2, 2020, and that continued through December 1, 2020;
	Denial of payment for new Medicare admissions for each day of a period that began on November 25, 2020, and that ran through December 1, 2020; and
	A directed plan of correction.I sustain each of these remedies as reasonable.

The regulatory criteria for deciding the reasonableness of civil money penalties are stated in 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 criteria include the seriousness of a facility's noncompliance, its culpability, and its compliance history.

CMS imposed the $15,975 per-diem penalty to remedy Petitioner's immediate jeopardy level failure to comply with infection control requirements.  It imposed an additional non-immediate jeopardy level penalty amount to address continuing, albeit non-immediate jeopardy level, noncompliance with the infection control requirements until full compliance was achieved.  The immediate jeopardy level penalty is within the range of permissible immediate jeopardy level penalty amounts as was provided for by regulations in 2020.  42 C.F.R. § 488.438(a)(1)(i); 45 C.F.R. § 102.3.  In fact, the penalty amount is only about three-quarters of the allowable daily maximum for immediate jeopardy level noncompliance.

I find that the seriousness of Petitioner's noncompliance more than justifies this penalty.  Any failure by a facility to comply with its own policies to protect residents against infection may invite Covid into the premises, an illness that is wildly infectious and frequently fatal among nursing home residents.  These residents are helpless individuals, at the mercy of facility staff to protect them against a fatal illness.  Failure by a facility to implement its own policies to protect residents against infection is a grave betrayal of trust and an abdication of responsibility.

I note also that Petitioner does not have a good compliance history.  Since 2017 Petitioner had been cited for noncompliance with Medicare participation requirements on seven occasions.  CMS Ex. 20 at 2.

Petitioner does not explicitly challenge the immediate jeopardy level penalty amount.  It does challenge the duration of the penalty, asserting that if it was noncompliant, it corrected its noncompliance by October 21, 2020.  Petitioner therefore contends that the immediate jeopardy level penalty amount, if it is imposed at all, should only be for one day.  Petitioner's Post-Hearing Brief at 20.  Petitioner cites to the testimony of Alan Bass, who was Petitioner's acting administrator at the time, as support for its contention.  P. Ex.

Page 15

9 at 5.  Additionally, it cites to a document that it purports to be a plan of correction that Petitioner implemented.  P. Ex. 4 at 1-2.

Correcting noncompliance means not only that the facility corrected the specific cited instances of deficiency, but also that it implemented a plan of correction designed to assure that no future incidents would occur.  A facility remains noncompliant until it affirmatively demonstrates that it has achieved substantial compliance once again.  *Life Care Ctr. of Elizabethton*, DAB No. 2367 at 16-17 (2011); *Premier Living & Rehab Ctr.*, DAB No. 2146 at 23 (2008); *Lake City Extended Care Ctr.*, DAB No. 1658 at 12-15 (1998).  The burden is on the facility to prove that it has resumed compliance with program requirements, not on CMS to prove that deficiencies continued to exist after they were discovered.  *Asbury Ctr. at Johnson City*, DAB No. 1815 at 19-20 (2002).  A facility's return to substantial compliance usually must be established through a resurvey. 42 C.F.R. § 488.454(a).

To be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation "acceptable to CMS" showing that it "was in substantial compliance and *was capable of remaining in substantial compliance*" on an earlier date.  42 C.F.R. § 488.454(e) (emphasis added); *Hermina Traeye Mem'l Nursing Home*, DAB No. 1810 at 12 (2002) (*citing* 42 C.F.R. § 488.454(a) and (e)); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998).

Petitioner failed to meet its burden.  The purported plan of correction and Mr. Bass' testimony are unpersuasive.  Moreover, they are refuted by Petitioner's own documents, which show that Petitioner did not complete its plan of correction within a day, as Petitioner alleges.

The purported plan of correction is an unsigned and undated document that merely states Petitioner's asserted intentions of the corrective actions it would take.  It offers no proof that those actions were taken and when.  P. Ex. 4 at 1-2.  As to Mr. Bass' assertions, they are without foundation.  He asserts, baldly, that Petitioner completed all corrective actions by October 21, 2020.  P. Ex. 9 at 5.  He cites no documentation to support that assertion and Petitioner cites to none.  He contends that Petitioner's corrective action included in-service training of staff and a plan of removal activities.  But neither Mr. Bass nor Petitioner cite to any documentation showing that the in-service training was completed by October 21, 2020.  *See id.*

However, Petitioner's own documents – consisting of in-service training logs not cited by Petitioner in its post-hearing brief – refute Mr. Bass' contention that Petitioner retrained its staff in Petitioner's Covid prevention protocol by October 21, 2020.  P. Ex. 5.  They establish that in-service training was not completed at Petitioner's facility until after October 27, 2020, the date when CMS determined that immediate jeopardy at Petitioner's facility had been abated.  The logs record that on October 24, 2020, staff received

Page 16

training on signs and symptoms of Covid and Petitioner's Covid policy.  *Id.* at 6.  On October 29, 2020, some, but clearly not all, members of the staff received training on when and how to test for Covid.  *Id.* at 7.5

Furthermore, while in-service training of staff may be an important element of corrective action it is not the only corrective action that a facility must take.  Telling the staff what their obligations consist of is only a first step in achieving compliance.  Corrective action must be implemented.  In this case, that meant that Petitioner had the obligation to produce proof that staff were consistently filling out screening forms, that the forms were being reviewed consistently and promptly by designated personnel, and that testing for Covid was being conducted consistently and in accord with Petitioner's policy.  Petitioner's assertions about corrective action only address staff in-service training.  Petitioner offers no persuasive evidence as to implementation.

I find to be reasonable the penalty of $435 per‐day that CMS imposed as a continuing remedy, albeit at the non-immediate jeopardy level, for Petitioner's failure to comply with infection control requirements.  The penalty amount is minimal, comprising less than one-tenth of the maximum allowable daily penalty for non-immediate jeopardy level penalties.  45 C.F.R. § 102.3.

As to duration of the non-immediate jeopardy level penalty, I find that Petitioner failed to prove that it fully corrected its noncompliance before November 24, 2020, the date when CMS determined that Petitioner had abated its noncompliance with the infection control regulation.  Petitioner asserts that it came into compliance well before November 24.  Petitioner's Post-Hearing Brief at 21.  But it has offered no evidence that it did so aside from its incorrect claim that it abated all noncompliance by October 21, 2020.

CMS imposed the penalty amount of $225 per‐day for each day of the period running from November 2 through December 1, 2020, to remedy Petitioner's noncompliance with medication requirements.  This penalty is minimal, comprising only about three percent of the maximum allowable daily amount of non-immediate jeopardy level civil money penalties, and I find it justified by the potential for harm that was caused by Petitioner's misadministration of medication to Resident 1.

Petitioner asserts that the duration of the $225 per-day penalty is unreasonable because, allegedly, it came into compliance immediately with the medication administration regulation simply by obtaining a revised prescription for the Eliquis administered to Resident 1 and by conducting in-service training.  Petitioner's Post-Hearing Brief at 21.

Page 17

Mr. Bass declares in his declaration that in-service training on medication administration was completed on November 2, 2020.  P. Ex. 9 at 6.  I do not find this assertion to be credible.  Mr. Bass does not cite to supporting documentation and Petitioner provided none.

Petitioner contends that imposing two non-immediate jeopardy level daily penalties for overlapping periods of time is impermissible, claiming that it is unlawful "double punishment."  Petitioner's Post-Hearing Brief at 22.  It cites to no legal authority to support this claim.  In fact, the two penalty amounts clearly were imposed to remedy separate and distinct deficiencies.  Nothing in the regulations precludes CMS from doing so.  *See* 42 C.F.R. § 488.438(a)(1).

Petitioner does not challenge either CMS's authority to impose a denial of payment for new admissions or a directed plan of correction beyond claiming that it always complied with participation requirements.


          /s/
        Steven T. Kessel

                      Administrative Law Judge
      1. I rejected P. Ex. A because Petitioner filed it untimely.  The exhibit is an attachment to Petitioner's response to CMS's motion for summary judgment.  Petitioner did not file it as part of the pre-hearing exchange of exhibits that I had ordered. back to note 1
                      2. Petitioner made arguments in Petitioner's Response that it did not reiterate explicitly in its post-hearing brief.  See Petitioner's Post-Hearing Brief.  I do not find that it abandoned those arguments and for that reason I address arguments made by Petitioner in Petitioner's Response and in Petitioner's Post-Hearing Brief.  I cite to each brief as is appropriate in order to identify the arguments that Petitioner made. back to note 2
                      3. Indeed, and as I discuss below, failure by a skilled nursing facility to comply scrupulously with its Covid infection prevention and control policy creates a likelihood that residents will suffer serious injury, harm, impairment, or death from Covid infection. back to note 3
                      4. As an element of its case against Petitioner, CMS argues that Petitioner's policy mandated that Mr. Rice be tested for Covid on October 13, 2020, but that Petitioner failed to test him on that date.  That is not the same as asserting that Petitioner failed to comply with county testing requirements. back to note 4
                      5. The logs also show that Petitioner's staff received training on "Covid-19" on October 20, 2020, but the scope of that in-service training is not described.  Clearly, however, it was not all-inclusive, given that there were subsequent in-service sessions on October 24 and 29.  P. Ex. 5 at 14-16. back to note 5 Back to top
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