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                              Hyde Park Health Center, DAB CR6221 (2023)
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Hyde Park Health Center, DAB CR6221 (2023)








  
  
    

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





Hyde Park Health Center,
(CCN: 365044),
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-21-156Decision No. CR6221January 20, 2023

        
              
    

      DECISION

The case before me involves a long-term care facility’s responsibility to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

Petitioner, Hyde Park Health Center (Petitioner or the facility), is a skilled nursing facility (SNF) in Cincinnati, Ohio.  The Ohio Department of Health (state agency or ODH) is designated as the state survey agency for Ohio for monitoring compliance with the Centers for Medicare and Medicaid Services’ (CMS’s) federal nursing home rules and regulations.  On June 23 and June 24, 2020, the ODH conducted a COVID-19 Focused Infection Control Survey of the facility.  Based on its survey, the ODH issued a Statement of Deficiencies (SOD) finding that Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) (Infection Prevention & Control), at a scope and severity level of “F.”1  Specifically, the SOD documented that on

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June 23, 2020, the ODH Surveyor (Surveyor) observed the facility’s receptionist and screener wearing a facemask that was pulled down exposing the individual’s mouth and nose.  On the same day, the Surveyor observed nine of the facility’s residents without facemasks eating lunch together at three individual tables and closer than six feet apart.

For the reasons discussed below, I find that the facility was not in substantial compliance with the Medicare program requirement at 42 C.F.R. § 483.80 and that the penalty is reasonable.

I.   Procedural Background

The ODH issued an initial determination dated June 27, 2020, imposing a directed plan of correction and a discretionary denial of payment for new admissions (DPNA), if Petitioner failed to achieve substantial compliance by July 27, 2020.  CMS Exhibit (Ex.) 2 at 1-2.  Further, the ODH recommended that CMS impose a civil money penalty (CMP) and terminate Petitioner’s Medicare provider agreement by December 24, 2020, if Petitioner failed to achieve substantial compliance by that date.  CMS Ex. 2 at 3.

In an August 11, 2020 letter, the ODH informed Petitioner that a July 28, 2020 desk review showed that Petitioner had returned to substantial compliance with Medicare participation requirements as of July 15, 2020.  CMS Ex. 3 at 1.  The ODH also recommended that CMS discontinue the imposition of enforcement remedies effective July 15, 2020, further confirming that the DPNA not go into effect.  CMS Ex. 3 at 1‐2.

On September 16, 2020, CMS issued an initial determination adopting the ODH’s survey findings and imposing a $20,000 per-instance CMP for the noncompliance at 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880).  CMS Ex. 4 at 2.  Because the ODH determined Petitioner was in substantial compliance by July 15, 2020, CMS did not effectuate the DPNA or the termination of Petitioner’s Medicare provider agreement.  CMS Ex. 4 at 1‐2.

Petitioner timely requested a hearing (RFH) before an Administrative Law Judge (ALJ) on November 13, 2020, to dispute the deficiency and CMP.  On November 17, 2020, the presiding ALJ2  acknowledged Petitioner’s hearing request and issued a Standing Order (Order).  The Order established prehearing submission procedures and dates for the submission of prehearing exchanges.  The Order further set deadlines for the parties to

Page 3

submit their written request and intention to cross-examine opposing party witnesses.  On February 16, 2021, CMS filed a combined brief and motion for summary judgment (CMS Br.).  CMS also submitted 13 proposed exhibits (CMS Exs. 1-13), which included the written direct testimony for one witness, Bridgid Cornell, RN, LNHA (CMS Ex. 11).  On April 1, 2021, Petitioner filed a prehearing brief in opposition to the motion for summary judgment (P. Br.) and submitted 27 proposed exhibits (P. Exs. 1-27).3  Petitioner’s exhibits included the written direct testimony for three witnesses:  Diane Hubbell, Petitioner’s Receptionist (P. Ex. 1); John W. Groves, RN, Petitioner’s former Assistant Director of Nursing and Infection Preventionist (P. Ex. 2); and Bryan W. McEachern, M.D. (Dr. McEachern), expert witness (P. Ex. 3).  CMS filed a reply, which included a request to cross-examine Dr. McEachern, as well as objections to some of Petitioner’s proposed exhibits.

On March 9, 2022, the presiding ALJ issued a Notice of Hearing (NOH) setting this matter for hearing for May 16, 2022.  In the NOH, the ALJ denied CMS’s motion for summary judgment, finding a dispute of material fact.  The ALJ further admitted all of CMS’s proposed exhibits as there were no objections to the exhibits.  The ALJ noted that CMS objected to Petitioner Exhibits 1, 3, 5, 7, 10, 11, 13, 14, 19, and 24.  The ALJ admitted Petitioner Exhibits 1-4, 6-9, 11-13, 15-23, 25-27 and excluded Petitioner Exhibits 5, 10, 14, and 24.  The NOH included the basis for the admission and exclusion of the specific proposed exhibits.  NOH at 2-5.  The ALJ only provisionally admitted Petitioner Exhibit 3, Dr. McEachern’s written testimony, and indicated the exhibit would be considered fully admitted into the record either after CMS cross‐examined Dr. McEachern at the hearing or CMS withdrew its request to cross‐examine Dr. McEachern.

On April 18, 2022, CMS withdrew its request to cross-examine Dr. McEachern.  The presiding ALJ canceled the May 16, 2022 hearing and closed the record, stating that a decision would be issued on the written record.  The ALJ also admitted Petitioner Exhibit 3 (Dr. McEachern’s testimony) into the record.

II.   Applicable Legal Authorities

The Social Security Act (Act) sets forth requirements for SNFs or long-term care (LTC) facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in Medicare, a LTC facility must be in “substantial compliance” with the participation requirements in 42 C.F.R. Part 483, subpart B.  42 C.F.R. §§ 483.1, 488.400.  A “deficiency” is a “failure to meet a participation requirement.”  *Id.*;42 C.F.R.

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§ 488.301.  A LTC facility is not in “substantial compliance” when it has one or more deficiencies that have the potential for causing more than minimal harm to residents.  *Id.*

The Secretary contracts with state survey agencies to survey LTC facilities to determine whether they are in substantial compliance with program requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  CMS may impose enforcement remedies based on the survey results, including a per-day or per-instance CMP, on a LTC facility that is not in substantial compliance.  42 C.F.R. §§ 488.400, 488.402(b), (c), 488.406.  CMS determines the amount of a CMP based on multiple factors, which include the “seriousness” of the noncompliance.  42 C.F.R. §§ 488.404(b), 488.438(f).  “Seriousness” is a function of the noncompliance’s scope (whether it is “isolated,” constitutes a “pattern” or is “widespread”) and severity (whether it has created a “potential for harm,” resulted in “actual harm,” or placed residents in “immediate jeopardy”).  42 C.F.R. § 488.404(b).

III.   Issues

The issues before me are:

Whether the facility was in substantial compliance with 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f).
	Whether the CMP imposed for the non-compliance is reasonable.IV.   Findings of Fact, Conclusions of Law, and Analysis4  ****

***Petitioner was not in substantial compliance with 42 C.F.R. § 483.80.*

	**Governing Guidelines and Authority****42 C.F.R. § 483.80 provides that a LTC facility “must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.”

On April 24, 2020, CMS issued a Memorandum concerning CMS’s targeted inspection plan to keep nursing home residents safe in the face of the COVID-19 pandemic.  CMS Ex. 9.  The Memorandum included a listing of Frequently Asked Questions (FAQs) to clarify guidance for state survey agencies and nursing home providers.  CMS Ex. 9 at 4‐15.  The FAQs contained a section pertaining to communal dining.  CMS Ex. 9 at 13.  While the Memorandum confirmed that residents are not forced to eat in their rooms, nursing facilities were directed to adhere to social distancing, such as seating residents at

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separate tables at least six feet apart.  CMS Ex. 9 at 13.  Further, the Memorandum mandated that social distancing should be practiced at all times and not just while the residents are dining.  CMS Ex. 9 at 13.

On June 19, 2020, the Centers for Disease Control and Prevention (CDC) issued updated guidelines entitled Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic.  CMS Ex. 12 at 3.  The guidelines provided, among other things, that healthcare personnel should wear a facemask at all times when in the healthcare facility.  CMS Ex. 12 at 5.  The guidance noted that healthcare personnel included clerical and administrative staff, as well as employees providing direct resident care.  CMS Ex. 12 at 14.  The guidelines also provided that when possible, social distancing of six feet between people was an important strategy to prevent transmission of the virus and the guidelines listed several ways in which social distancing may be utilized.  CMS Ex. 12 at 6.  While the guidelines did not specifically address the placement of residents in communal dining areas, the guidelines suggested arranging seating in waiting rooms or in group healthcare activities so that patients can sit at least six feet apart.  CMS Ex. 12 at 6.  Additionally, the guidelines provided for designating areas for healthcare personnel to take breaks, eat, and drink that will allow them to remain at least six feet apart from each other, especially when they must be unmasked.  CMS Ex. 12 at 6.

**The Facility’s Policies for Dealing with COVID-19**The facility’s March 11, 2020 Infection Control COVID-19 Policy included its policies and procedures for dealing with COVID-19 within its campus.  CMS Ex. 7.  The policy acknowledged that the facility residents were at high risk of harm from the virus and the policy specified the actions that it would take to assist in preventing transmission of COVID-19 into the facility.  CMS Ex. 7 at 1.  The policy stated that the facility would monitor the CDC website routinely and would update the policy as needed.5  CMS Ex. 7 at 1.  The policy included the risk levels for the healthcare personnel who had both direct and indirect exposure to residents.  CMS Ex. 7 at 3.  Personnel who had no identifiable risks were to adhere to “routine safety precautions.”  CMS Ex. 7 at 3.  The policy provided for social distancing of six feet or more when possible.  CMS Ex. 7 at 4.

**Background
	**The Citation for the Facility’s Receptionist’s Failure to Adequately Wear a Facemask****Page 6

When the ODH surveyor, Bridgid Cornell (Surveyor), entered the facility at 12:00 p.m. on June 23, 2020, she observed Petitioner’s Receptionist (Receptionist) acting as the screener for individuals entering the facility.  The Surveyor noted that while the Receptionist wore a facemask, the facemask was pulled down, exposing her nose and mouth.  The Receptionist encouraged the use of hand sanitizer, asked for identification, and requested to take the Surveyor’s temperature.  The Surveyor testified that the Receptionist did not pull up the facemask to cover her nose and mouth until the Surveyor requested that she do so prior to taking her temperature.  CMS Ex. 1 at 3; CMS Ex. 6 at 1; CMS Ex. 11 at 2.  The Surveyor interviewed Registered Nurse John W. Groves (RN Groves) at 12:10 p.m. on June 23, 2020, who confirmed that all staff are required to wear face coverings while in the facility when face to face contact with other persons was likely.  CMS Ex. 1 at 4; CMS Ex. 6 at 1; CMS Ex. 11 at 2.

Petitioner does not deny that there was a facemask mandate in place at the time of the Surveyor’s visit to the facility.  P. Br. at 9.  Petitioner submitted the testimony of the Receptionist who testified that she is careful to keep her facemask positioned when she comes into contact with visitors, staff members, or residents.  She testified that she recalled the Surveyor visiting the facility on June 24, 2020.6  While she recalled her facemask slipping below her nose, she contends that she quickly corrected the positioning.  She further testified, “At no time did the surveyor ask me to reposition my mask or put my mask back on.”  P. Ex. 1 at 1.

**The Facility’s Failure to Provide Social Distancing for Residents**The Fountain Unit of the facility is a locked unit and all of the residents in that unit have varying degrees of dementia.  P. Br. at 10; P. Ex. 2 at 2.  The Surveyor entered the Fountain Unit’s dining area on June 23, 2020, at 12:15 p.m.  She observed nine residents who were sitting together at tables closer than six feet apart.  The tables were small, square, and accommodated seating for up to four residents.  The Surveyor observed three residents sitting together at one table; two residents sitting together at another table; and four other residents sitting together at another table.  CMS Ex. 1 at 4-5; CMS Ex. 6 at 1; CMS Ex. 11 at 2.

Petitioner does not deny that the residents were sitting together as the Surveyor documented.  Petitioner submitted the testimony of two witnesses to explain why the residents were sitting together as observed.  RN Groves testified that Petitioner made efforts to maintain social distancing by attempting to stagger meals, adding additional tables, and encouraging the residents to not sit close to each other.  P. Ex. 2 at 2-3.  He added that because of their mental conditions, the residents in the dementia unit do not

Page 7

follow instructions well.  P. Ex. 2 at 3.  He testified that some residents refuse to eat or they eat much less if they cannot eat with other residents and this can lead to multiple health problems if the residents’ diet cannot be maintained*.*P. Ex. 2 at 3.  He explained that because the residents are mobile either by ambulation or by wheelchair, they will move to eat with others even if initially seated separately.  P. Ex. 2 at 3.

Petitioner also submitted the testimony of Dr. McEachern, who asserted that he “was qualified as an expert in COVID-19 and infection control for several Independent Informal Dispute Resolutions, in multiple State [sic], and by an Administrative Law Judge during an appeal hearing in Maryland.”  P. Ex. 3 at 1.  Dr. McEachern testified that persons suffering from dementia typically do better in social situations, as opposed to being in isolation.  P. Ex. 3 at 1.  He testified that in dealing with persons suffering from dementia, it is necessary to take a holistic view and to balance the risks of interventions such as social isolation against the costs of the intervention.  P. Ex. 3 at 1.  Further, he asserts that for residents at the end of life, increased weight should be given to short term happiness or comfort.  P. Ex. 3 at 1.  He testified that from what he reviewed, it appears that the staff was acting in the best interests of these residents on the dementia unit.  P. Ex. 3 at 1.

**Discussion and Analysis**The Surveyor was unwavering in her testimony that the Receptionist’s facemask was positioned below her nose and mouth when the Surveyor entered the facility on June 23, 2020.  CMS Ex. 11 at 2.  Petitioner maintains, however, that while the Receptionist’s facemask momentarily slipped below her nose, it did not expose her mouth and she quickly corrected the facemask placement.  RFH at 3.  The Receptionist also vehemently denies that the Surveyor asked her to reposition her facemask or to replace it.  P. Ex. 1 at 1.  Clearly the parties’ witnesses give totally contradictory accounts of what occurred upon the ODH Surveyor’s arrival at the facility.

While Petitioner denies that the events occurred as alleged by the Surveyor, Petitioner submits that the facility’s Receptionist works in a non-resident area and that residents are not allowed in the front lobby area.  Further, Petitioner asserts that the Receptionist’s two-minute contact with the Surveyor in a non-patient care area presented no risk of harm whatsoever to any resident.  P. Br. at 9.

The Board has recognized that an ALJ need not address every disputed deficiency finding so long as the findings that the ALJ made support a legal basis for imposing a remedy, namely a CMP.  *Mercy Home* *Care, Sioux City*, DAB No. 3044 at 22 (2021) (citations omitted).  The Board has additionally held that an ALJ has discretion, as an exercise of judicial economy, not to address findings that are immaterial to the outcome of an appeal.  *Alexandria Place*, DAB No. 2245 at 27 n.9 (2009).  Accordingly, and in light of the Board’s explanation in *Alexandria Place*, I find that the deficiency citation for the

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Receptionist’s placement of her facemask is not material to the outcome of the case.  Therefore, I make no finding with respect to the citation concerning the Receptionist’s facemask placement.  The deficiency in failing to provide social distancing for its residents, however, is sufficient in itself to support the CMP that CMS seeks to impose.

Petitioner advances several arguments to refute CMS’s finding of noncompliance and the imposition of the CMP.  Petitioner asserts that the CMS and the CDC promulgated various “guidance” documents during the spring of 2020.  Petitioner contends, however, that “CMS has never said whether, or how, any of the changing CMS and CDC ‘guidance’ documents regarding the methods of staff screening, documentation thereof, use of [personal protective equipment], and the like, imposed specific regulatory obligations under Section 483.80.”  P. Br. at 7.  Petitioner’s argument is somewhat similar to an argument posed to the Board by a SNF that experienced an influenza outbreak.  In *Golden Living Ctr. – Superior*, the facility argued that it did not violate 42 C.F.R. § 483.65 because the regulation does not articulate standards for influenza control.  *Golden Living Ctr. – Superior*, DAB No. 2768 at 5 (2017).  The facility argued that the regulation fails to identify specific infection control requirements applicable to influenza outbreaks.  *Golden Living*, DAB No. 2768 at 4.  The Board found this argument to be a “red herring” noting that the regulation governing infection control at SNFs is not predicated on inflexible and rigid standards.  *Golden Living*, DAB No. 2768 at 5.  The Board further noted that putting specific objective requirements in the regulations undercuts the statutory purpose of assuring that SNFs have the flexibility to adapt their protocols to changed circumstances.  *Golden Living*, DAB No. 2768 at 5.  However, once a SNF has protocols in place to deal with the infectious disease, it is required to implement its protocols and to assure that they are working*.  Golden Living*, DAB No. 2768 at 5.

42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880) requires a facility to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.  The facility’s Infection Control COVID-19 Policy dated March 11, 2020, stated that its policies and practices are based on infection prevention and control recommendations from the CDC, State Department of Health, and the World Health Organization.  CMS Ex. 7 at 1.  The policy noted that the facility will monitor the CDC website routinely and update the Infection Control COVID‐19 Policy as needed.  CMS Ex. 7 at 1.  The policy clarified that individuals sitting within six feet of each other in a healthcare common area falls within the definition of close contact for healthcare exposure to the virus.  CMS Ex. 7 at 2.  Thus, the facility’s guidelines acknowledge the necessity for social distancing to protect the residents from exposure to COVID-19.  Further, the policy provides that Standard Precautions for preventing the introduction of COVID-19 into the facility apply to all resident care, regardless of suspected or confirmed infection status and include maintaining social distances, when possible, of six feet or greater.  CMS Ex. 7 at 4.

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Furthermore, Standard Precautions are infection prevention practices that apply to all residents, regardless of suspected or confirmed diagnosis or presumed infection status.  CMS Ex. 7 at 2.

There is a line of Board decisions holding that CMS “may reasonably rely on a facility’s understanding of what must be done to attain or maintain residents’ highest physical, mental, and psychosocial well-being, as required by section 483.25.”  *Green Valley Healthcare & Rehab. Ctr*., DAB No. 2947 at 6 (2019) (citing *The Laurels at Forest Glenn,* DAB No. 2182 at 18 (2008)); *N. Las Vegas Care Ctr.*, DAB No. 2946 at 6 (2019); *Hanover Hill Health Care Ctr*., DAB No. 2507 at 6 (2013).  Clearly, Petitioner’s polices in place at the time of the June 2020 survey visit provided for social distancing as a means of preventing and controlling the spread of COVID-19.

Petitioner also asserts “CMS does not even allege, much less explain, how the noncompliance it alleges caused, or plausibly could have caused harm to any resident.” P. Br. at 7.  Petitioner is correct that CMS has not submitted any proof that the alleged actions resulted in specific harm to any resident.  However, contrary to Petitioner’s assertion, proof that a deficiency caused actual harm is not a prerequisite to finding a lack of compliance with program requirements.  Under 42 C.F.R. § 488.301, a SNF may be found out of compliance if the deficiency has the “potential” to cause more than minimal harm to resident health and safety.  *N. Las Vegas Care Ctr*., DAB No. 2946 at 9 (citing *Libertyville Manor Rehab. & Healthcare Ctr*., DAB No. 2849 at 17-18 (2018); *Oaks of Mid City Nursing* *and Rehab. Ctr.,* DAB No. 2375 at 16‐17 (2011)); *see also* *Oak Ridge Ctr.*, DAB No. 2913 at 29 (2018) (citing *Lakeport Skilled Nursing Ctr.*, DAB No. 2435 at 5 (2012)).  Disregarding its own policy and allowing the residents in the dementia unit to sit together with a very real risk of infectious disease has the potential for more than minimal harm to their health and safety.  This risk was especially serious in a time of a worldwide pandemic where there were not yet vaccines or precautions available to those with advanced age and/or compromised health other than social distancing and personal protective equipment such as facemasks.

Submitting the testimony of RN Groves, Petitioner contends that although the staff did their best to keep the residents separated, dementia residents do not follow instructions well and they removed their facemasks or refused to wear the facemasks.  P. Br. at 10.

Relying on the opinion of Dr. McEachern, Petitioner contends that the staff is required to balance competing concerns and must provide a holistic approach to maintain the residents’ highest practicable physical, mental, and/or psychological well-being.  P. Br. at 10.  Petitioner takes the position that its approach to allow the dementia residents to eat with other residents was the best approach.  Petitioner submits that Dr. McEachern’s and RN Groves’ testimony “establish that it was not possible to maintain social distancing among the dementia patients at all times and that to provide the best overall holistic care for these residents, the Center had to encourage them to eat and hydrate which also

Page 10

involved socialization.”  P. Br. at 11.  While Petitioner argues that CMS has presented no facts to the contrary, this argument has no merit.  Despite the testimony and opinions expressed by Dr. McEachern and RN Groves, Petitioner has not demonstrated that these witness’ assessments or experiences supersede CMS and CDC guidelines or the facility’s existing guidelines for addressing infectious disease and COVID-19.

***There is a basis for the imposition of a CMP and the amount of the CMP imposed by CMS is reasonable.***The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.  ALJs and the Board review whether a CMP is reasonable under the regulatory factors and can change the amount if they find the CMP is not reasonable based on the factors.

As I have found that there is a basis for the imposition of an enforcement remedy, I must also determine the reasonableness of the CMP that CMS seeks to impose.  However, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  Specifically, (1) I may not set the CMP at zero or reduce it to zero; (2) I cannot review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f).  Those factors include:  (1) the facility’s history of compliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the factors specified at 42 C.F.R. § 488.4047 ; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  *See* 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f)(4).

In this case, CMS imposed a single per-instance CMP of $20,000, an amount at the upper range allowable.  CMS Ex. 4 at 2; *see*42 C.F.R. §§ 488.406(a)(3) and 488.430(a); 45 C.F.R. § 102.3; 85 Fed. Reg. at 2869, 2886 (Jan. 17, 2020).  While Petitioner “challenges the Board’s policy that permits CMS to impose civil monetary penalties without offering evidence that it considered the regulatory criteria set forth at 42 C.F.R. §§ 488.404 and 488.438(f) as a violation of the Medicare Act and due process of law” (RFH at 4), Petitioner failed to argue that any of the factors support a reduction of the CMP amount.  Therefore, I could conclude that the CMP amount is reasonable.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).  However, even applying the regulatory factors, I find that the CMP is reasonable.

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Petitioner does not address its financial condition with respect to the CMP.  Although CMS’s September 16, 2020 letter asked the facility to submit evidence of financial hardship within 15 days of the letter (CMS Ex. 4 at 2), Petitioner does not argue the facility’s financial condition to be a factor affecting the penalty amount.  With respect to the facility’s history of noncompliance with Medicare program participation requirements, CMS submitted the facility’s AEM Enforcement History, which includes survey findings in 2019.  CMS Ex. 13.  The history reflects that in a complaint investigation survey in December 2019, the facility was cited for a violation of Tag F880, at a scope and severity level of “E.”  CMS Ex. 13 at 2.  Prior to that, in October 2019, the facility was cited for a violation of Tag F880 at a scope and severity level of “D.”  CMS Ex. 13 at 2-3.  While CMS concedes these violations were prior to the COVID‐19 pandemic, CMS argues that they show repeated behavior by the facility in violating infection control.  CMS Br. at 14.  Petitioner does not dispute the prior violations or address CMS’s argument that they show repeated behavior in violating infection control.

As discussed above, I find the facility’s failure to maintain social distancing for the nine residents in the dementia unit to be quite serious.  Petitioner argues that because of the residents’ mental status, the facility could not keep the residents from sitting together in the dining area.  It was the residents’ mental status, however, that created an even greater risk with the lack of social distancing.  It is conceivable that because of their cognitive limitations, these residents may not have been able to understand the risks of COVID-19 and could not self-impose protective measures against the virus.  To allow these residents to risk infection because of their mental status poses a serious threat to their well-being.

I have also considered the facility’s culpability and find it significant.  While the facility argues that it took measures to encourage the residents to maintain social distancing, Petitioner asserts that dementia residents do not follow instructions well.  P. Br. at 10.  Petitioner submits that the dementia residents removed their masks no matter how many times they were asked to wear masks and the residents also refused to eat if not allowed to eat with other residents.  P. Br. at 10.  Petitioner asserts that it is simply not possible to ensure social distancing with mobile dementia patients.  P. Br. at 10.  Petitioner contends that the facility staff are required to balance competing concerns and to provide a holistic approach to the overall care of the residents.  P. Br. at 10.  Thus, there is no dispute that the nine residents sitting together in the dining area did so with the facility staff’s knowledge and acquiescence.

While I have not made a finding with respect to CMS’s allegation concerning the positioning of the Receptionist’s facemask, I nevertheless find that the CMP is reasonable based on the remaining alleged deficiency.  *See Emerald Shores Health & Rehab. Ctr.*, DAB No. 2072 at 30 (2007); *The Residence at Salem* *Woods*, DAB No. 2052 at 11 (2006).  The facility’s failure to enforce social distancing and the potential risk to these vulnerable residents is quite serious and supports the imposition of the CMP which CMS seeks.

Page 12

V.   Conclusion

For the foregoing reasons, I find that the facility was out of substantial compliance with 42 C.F.R. § 483.80(a)(1) and (2) and Petitioner’s noncompliance had the potential for more than minimal harm.  I also find that the imposition of a $20,000 per-instance CMP is reasonable.

Endnotes

1   Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  A severity level of “F” indicates a deficiency that poses no actual harm but has the potential for more than minimal harm that does not rise to the level of immediate jeopardy.

2   The case was initially assigned to a different ALJ and then later transferred to the undersigned.

3   Petitioner initially submitted its pre-hearing brief on April 1, 2021.  On April 8, 2021, Petitioner re-submitted its brief and included pages that were missing from the April 1, 2021 document.

4   My findings of fact and conclusions of law appear as headings in bold italic type.

5   Referencing 81 Fed. Reg. 68,688, 68,808 (Oct. 4, 2016), CMS argues that CDC guidance is one source of accepted national standards for purposes of compliance with 42 C.F.R. § 483.80(a)(1).

6   The Surveyor testified that she observed the Receptionist without her mask in place on June 23, 2020.  CMS Ex. 11 at 2.  The Receptionist testified that her interaction with the Surveyor occurred on June 24, 2020.  P. Ex. 1 at 1.

7   The factors at 42 C.F.R. § 488.404 include:  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.
  
          /s/
        Margaret G. Brakebusch

                      Administrative Law Judge Back to top
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