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                              Avamere Transitional Care Center of Puget Sound, DAB CR6055 (2022)
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Avamere Transitional Care Center of Puget Sound, DAB CR6055 (2022)








  
  
    

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





Avamere Transitional Care Center of Puget Sound,
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-21-476Decision No. CR6055March 29, 2022

        
              
    

      DECISION

The issue before me involves a long-term care facility's responsibility to implement its infection protection and control program by fit testing respirator masks for staff.

Petitioner, Avamere Transitional Care Center of Puget Sound (Petitioner or facility), is a skilled nursing facility (SNF) in Tacoma, Washington that participates in the Medicare program.  On January 22, 2021, the Washington Department of Social and Health Services, (DSHS), a contractor for the Centers for Medicare & Medicaid Services (CMS), completed an unannounced onsite infection monitoring survey and determined that the facility was not in substantial compliance with Medicare participation requirements regarding infection control at 42 C.F.R. § 483.80 (Tag F 880), at scope and severity level "F."1
  CMS Ex. 2 at 1-3.  Specifically, DSHS determined that Petitioner failed to implement its infection prevention and control program (IPCP) by not fit testing N95

Page 2

respirators2
 for its staff.  As a remedy, DSHS imposed a Directed Plan of Correction (DPOC), which required Petitioner to submit a completed Plan of Correction within 10 calendar days.  Petitioner's failure to correct the deficiency would result in a denial for all new Medicare and Medicaid admissions.  CMS Ex. 3 at 1-2.

For the reasons discussed below, I find that there is no dispute as to any material fact and that CMS is entitled to judgment as a matter of law because the facility was not in substantial compliance with Medicare program requirements at 42 C.F.R. § 483.80.

I.  Procedural Background

In a notice dated February 3, 2021, DSHS notified Petitioner of the deficiency at 42 C.F.R. § 483.80 (Tag F 880) and imposed the DPOC, a remedy under 42 C.F.R. § 488.424.  CMS Ex. 3 at 1-2.  On February 10, 2021, Petitioner filed an appeal and a request for a hearing before an Administrative Law Judge (ALJ).  On February 12, 2021, the ALJ3
 issued an Acknowledgment and Pre-Hearing Order (Order) establishing deadlines for pre-hearing briefs and proposed exhibits.  Order at 3.  The Order also set deadlines for the parties to submit their written request and intention to cross-examine opposing party witnesses.  Order at 7.  The ALJ explained that a hearing to cross‐examine witnesses would only be necessary if a party files a timely request to cross-examine opposing party witnesses.  Order at 5-6.

In a notice dated February 25, 2021, DSHS informed Petitioner that the cited deficiency had been corrected and that Petitioner was in compliance as of February 11, 2021.  DSHS also advised that the proposed denial of payment for new admissions would not be implemented.  CMS Ex. 4 at 1.

On May 12, 2021, CMS filed its pre-hearing brief and a motion for summary judgment, proposed witness and exhibit lists, and 10 proposed exhibits (CMS Exs. 1-10).  On June 24, 2021, the ALJ issued an Order to Show Cause why Petitioner's request for hearing should not be dismissed because Petitioner had not filed its pre-hearing exchange by the June 17, 2021 deadline.  The Order to Show Cause set a deadline of July 6, 2021, for Petitioner's response and stated that absent a timely response, the ALJ would dismiss the request for hearing.  On July 8, 2021, the ALJ dismissed the Petitioner's request for hearing under 42 C.F.R. § 498.69 because Petitioner failed to respond to the Order to Show Cause.

Page 3

On July 8, 2021, Petitioner filed a request for reconsideration, citing a misunderstanding of procedures, a lack of knowledge of electronic filing, and an apology for missing its prehearing exchange deadline.  On July 9, 2021, the ALJ issued an Order Vacating Dismissal and Scheduling Petitioner Pre-Hearing Exchange.

On July 16, 2021, Petitioner submitted eight supporting documents.  *See* DAB E-File #s 11-18.4
  On July 19, 2021, the ALJ rejected Petitioner's filing and established July 26, 2021, as Petitioner's deadline for filing a compliant exchange.  DAB E-File # 19.  On July 23, 2021, Petitioner submitted its pre-hearing brief and opposition to CMS's motion for summary judgment (P. Br.), proposed witness and exhibit lists, and 18 proposed exhibits (P. Exs. 1-18).

Neither party filed objections to the opposing party exhibits or a request to cross-examine opposing party witnesses.  Accordingly, I receive CMS Exs. 1-10 and P. Exs. 1-18.

II.  Applicable Law

**A. Existing Authority**

The Social Security Act (Act) sets forth requirements for SNFs 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 the Medicare program, a SNF must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm."  42 C.F.R. § 488.301 (substantial compliance).

The Secretary contracts with state survey agencies to survey SNFs in order to determine whether those SNFs are in substantial compliance with program requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

Page 4

42 C.F.R. § 483.80 provides that a SNF "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."  42 C.F.R. § 483.80(f) provides that the SNF "will conduct an annual review of its IPCP and update their program, as necessary."

**B. DSHS's Application of the Law**

The Departmental Appeals Board (DAB or Board) has summarized the roles of state survey agencies and program deficiencies as follows:

A state survey agency reports any "deficiencies" it finds in a Statement of Deficiencies (SOD), which identifies each deficiency under its regulatory requirement and the corresponding "tag" number.  A "deficiency" is any failure to comply with a Medicare participation requirement, and "substantial compliance" means "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm."

*Bivins Memorial Nursing Home,* DAB No. 2771 at 2 (2017) (citing 42 C.F.R. § 488.301).  After completing an infection monitoring survey on January 22, 2021, DSHS determined that Petitioner did not meet requirements imposed by 42 C.F.R. § 483.80.  CMS Ex. 2 at 2-4.  As relevant here, DSHS determined:

[T]he facility failed to implement the infection prevention and control program for fit test (to qualitatively or quantitatively evaluate the fit of a respirator on an individual) for the N95 respirators (a mask designated for specific use to prevent transmission of respiratory infections) to provide a safe, sanitary environment to help prevent the transmission and control the spread of COVID-19 (a highly transmissible infectious disease caused by the SARS-CoV-2 virus).  This failure had the potential for increased spread of infection throughout the facility due to lack of adequate fit testing for the N95 respirators.

Page 5

CMS Ex. 2 at 5.  DSHS issued the deficiency citation at scope and severity level "F."  CMS Ex. 2 at 1; CMS Ex. 3 at 1.

III.  Issues

The issues before me are:

Whether summary judgment is appropriate;
	Whether the facility was in substantial compliance with 42 C.F.R. § 483.80; and
	Whether Petitioner is entitled to a removal of the fit testing citation or a lowering of a citation from scope and severity level F to D.IV.  Jurisdiction

I have jurisdiction to decide this case.  42 C.F.R. §§ 498.3(b)(13), 498.5(b); *see also* CMS Ex. 3 at 5.

V.  Findings of Fact and Conclusions of Law and Analysis5

***A. Summary judgment is appropriate.***

An ALJ is empowered to decide a case on a motion for summary judgment without an evidentiary hearing.  *Shah v. Azar*, 920 F.3d. 987, 996 (5th Cir. 2019) (citing *Cedar Lake Nursing Home v. U.S. Dep't of Health and Human Servs.,* 619 F. 3d 453, 457 (5th Cir. 2010)).  Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law*.  Anderson v. Liberty Lobby, Inc.,* 477 U.S. 242, 247-48 (1986*)*; *Celotex Corp. v. Catrett*, 477 U.S. 317, 322-25 (1986).  In determining whether there are genuine issues of material fact for trial, the reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party's favor.  The moving party for summary judgment has the initial burden of demonstrating that there is no genuine issue of material fact for trial and that it is entitled to judgment as a matter of law.  *Celotex,* 477 U.S. at 323.  If the moving party carries that burden, the non-moving party must "come forward with ‘specific facts showing that there is a genuine issue for trial.'" *Matsushita Elec. Indus. Co. v. Zenith Radio Corp*., 475 U.S. 574, 587 (1986) (emphasis omitted).

Page 6

Viewing the evidence before me in a light most favorable to Petitioner and drawing all inferences in Petitioner's favor, I conclude that there is no genuine dispute as to any material fact pertinent to DSHS's Tag F 880 citation that would require a hearing in this case.  In its opposition to CMS' motion for summary judgment, Petitioner argues that Tag F 880 does not require fit testing specifically or even the use of N95s.  Petitioner also submits that DSHS conducted two prior surveys without finding deficiencies and argues that there was a severe and chronic shortage of Personal Protective Equipment (PPE) and qualified experts to perform fit testing.  P. Br. at 7.6
  Petitioner, however, does not dispute that at the time of the January 15, 2021 onsite survey, its employees were wearing N95 respirator masks that had not been fit tested.  As discussed further in my decision below, Petitioner has submitted an explanation for its failure to fit test its employees for the N95 respirator masks.

In ruling on a motion for summary judgment, a judge's function is not to weigh the evidence and determine the truth of the matter, but to determine whether there is a genuine issue for trial.  *Anderson v. Liberty Lobby, Inc.,* 477 U.S. at 255.  Thus, despite Petitioner's explanations for its failure to fit test its employees using N95 respiratory masks, there is no genuine dispute as to the material fact that it did not do so, and summary judgment is therefore appropriate.

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

**1. Applicable Authority**

42 C.F.R. § 483.80 requires the "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."  Subsections (a) and (f), respectively, require that a facility establish an IPCP and conduct an annual review of its IPCP and update their program, as necessary.  Regulations issued by the United States Department of Labor Occupational Safety and Health Administration (OSHA) require that, before an employee may be required to use any respirator with a negative or positive pressure tight-fitting facepiece, the employee must be fit tested with the same make, model, style, and size of the respirator that will be used.  29 C.F.R. § 1910.134(f).

Page 7

**2. Background**

On March 31, 2020, DSHS conducted an unannounced COVID-19 infection control survey at Petitioner's facility.  The investigation and survey were completed on April 23, 2020.  No deficiencies were found.  P. Ex. 4 at 1.

On April 1, 2020, Petitioner contracted with DSHS to serve as a COVID-19 Recovery Unit, as a means of dealing with the impact of the COVID-19 virus outbreak and impact on the medical and long-term care delivery system in the state of Washington.  P. Ex. 1 at 2 ¶ 5 (Fisher Decl.); *see* P. Ex. 12 at 1-2 (contract amendment no.7, amendment start date April 1, 2021).  Tonya Fisher, Petitioner's Administrator, testified that when Petitioner was selected to be a COVID-19 Recovery Unit, Petitioner had a shortage of N95 masks and was unable to obtain fit testing for the masks.  P. Ex. 1 at 2 ¶ 5.

On June 24, 2020, DSHS completed an unannounced COVID-19 infection control survey which was conducted at Petitioner's facility on June 22, June 23, and June 24, 2020.  No deficiencies were found.  P. Ex. 8 at 1.  Administrator Fisher testified that at the time of the June survey, Petitioner could not secure a fit test kit or an outside vendor who would conduct fit tests for the N95 masks.  P. Ex. 1 at 2 ¶ 6.  Administrator Fisher testified that from August 2020 until January 2021, Petitioner continued to work to obtain fit testing for the N95 masks; however, Petitioner was unable to do so because of the vast demand and short supply.  P. Ex. 1 at 2 ¶¶ 8-9.

Fisher testified that throughout December 2020, Petitioner continued to seek more N95s and fit testing.  However, Petitioner was continually advised that further N95s and fit testing were no longer available.  P. Ex. 1 at 3 ¶ 10.  Fisher also testified that as of January 11, 2021, Petitioner was finally given a date on which fit testing would be provided, and it was scheduled for January 25, 2021.  P. Ex. 1 at 3 ¶ 11.

On January 15, 2021, DSHS began its third COVID-19 infection control survey since the beginning of the COVID-19 pandemic.  CMS Ex. 1 at 2 ¶ 6 (Lu Decl.).  Additionally, an off-site investigation was conducted on January 19, January 20, and January 21, 2021.  CMS Ex. 1 at 2 ¶ 7 (Lu Decl.).  Fisher testified that at the time of this survey, Petitioner provided DSHS all documentation to show Petitioner's attempts to obtain fit testing for its N95 masks, in addition to confirming that fit testing was scheduled for January 25, 2021.  P. Ex. 1 at 3 ¶ 12.

During the DSHS surveyor's onsite visit to the facility on January 15, 2021, the surveyor interviewed several staff members who confirmed that they had not been fit tested for the

Page 8

N95 respirators.  CMS Ex. 2 at 6-7.  Petitioner's Interim Director of Nursing Services confirmed that he had attempted multiple times to get his staff fit tested for the N95 respirators.  However, he had not been able to do so for the past two months.  He confirmed that as of the date of the onsite visit, the staff members had not been fit tested for the N95 respirators.  CMS Ex. 2 at 7.

In a letter dated February 3, 2021, DSHS told Petitioner that, based on the January 22, 2021, infection control focus survey and complaint investigation, DSHS found a Tag F 880 deficiency.  DSHS further stated that because of the deficiency, DSHS was imposing a DPOC with a March 20, 2021 deadline to correct the violations or DSHS would deny all new Medicare and Medicaid admissions.  DSHS attached a copy of the SOD for an explanation of the deficiency.  CMS Ex. 3 at 1-2.

The SOD confirmed that during the January 15, 2021 unannounced on-site infection monitoring visit, the surveyor determined that Petitioner's staff had not been fit tested for the N95 respirators.  CMS Ex. 2 at 4-5.  The surveyor concluded, based on observation, interviews, and record review, as follows:

[T]he facility failed to implement the infection prevention and control program for fit test (to qualitatively or quantitatively evaluate the fit of a respirator on an individual) for the N95 respirators (a mask designated for specific use to prevent transmission of respiratory infections) to provide a safe, sanitary environment to help prevent the transmission and control the spread of COVID-19 (a highly transmissible infectious disease caused by the SARS-CoV-2 virus).  This failure had the potential for increased spread of infection throughout the facility due to lack of adequate fit testing for the N95 respirators.

CMS Ex. 2 at 5.

The SOD cites three resources upon which the surveyor relies in finding non-compliance.  The surveyor referred to CMS's April 2, 2020 guidance titled "COVID-19 Long-Term Care Facility Guidance" that includes the directive:  "Long term-care facilities should ensure all staff are using appropriate PPE when they are interacting with patients and residents."  CMS Ex. 2 at 5.  The surveyor also referred to OSHA regulation 29 C.F.R. § 1910.1349(a) (April 20, 2006), which provides:

Page 9

A respirator shall be provided to each employee when such equipment is necessary to protect the health of such employee.  The employer shall provide the respirators which are applicable and suitable for the purpose intended.  The employer shall be responsible for the establishment and maintenance of a respiratory protection program, the program shall cover each employee required by this section to use a respirator.

CMS Ex. 2 at 5.  The SOD continued:

In addition, section 1910.134(c)(1) showed "in any workplace where respirators are necessary to protect the health of the employee or whenever respirators are required by the employer, the employer shall establish and implement a written respiratory protection program with worksite-specific procedures" which include section 1910.134(c)(1)(iii) "fit testing procedures for tight- fitting respirators."

CMS Ex. 2 at 5-6.

Finally, the surveyor referred to the Petitioner's document titled "Avamere Living Respiratory Protection Program for use by Healthcare Facilities" policy, which states that employees required to wear N95 respirators must be fit tested.  CMS Ex. 2 at 6; *see* CMS Ex. 7 (rev. 8/20).  The policy also provides:  "N95 respirators vary by model and size.  Improper fit will likely result in inadequate protection."  CMS Ex. 2 at 6.

**3. Discussion and Findings**

As scheduled, Petitioner's employees were fit tested for the N95 respirators on January 25, 2021.  P. Ex. 1 at 3 ¶ 12 (Fisher Decl.).  In a notice dated February 25, 2021, DSHS told Petitioner that the deficiency which had been the basis for the DPOC imposed on February 3, 2021, was corrected and that Petitioner was back in compliance effective February 11, 2021.  CMS Ex. 4.

Page 10

**a. Petitioner's Position and Arguments**

Petitioner requests that, based on Petitioner's substantial compliance with the regulation, the "citation be removed in its entirety or that the scope and severity be reduced to level D (meaning the potential for harm was isolated) . . . ."  P. Br. at 2.7

**b. Petitioner's Reliance on Published Guidelines**

In support of its request, Petitioner cites OSHA's March 14, 2020 document captioned "Temporary Enforcement Guidance-Healthcare Respiratory Protection Annual Fit Testing for N95 Filtering Facepieces During the COVID-19 Outbreak."  P. Br. at 2 (citing P. Ex. 3 at 3).  As Petitioner correctly points out, the guidance states that the OSHA field offices shall exercise enforcement discretion concerning the annual fit testing requirement.  P. Br. at 2, 4; P. Ex. 3 at 2-3 (citing 29 C.F.R. § 1910.134(f)(2)).  This discretion is premised, however, on the employer taking seven specific actions.  As Petitioner cites, one of the employer actions listed is "make a **good-faith effort** to comply with 29 [C.F.R.] § 1910.134."  P. Br. at 2 (citing P. Ex. 3 at 3) (emphasis in original).  A second listed action is for employers to "[i]nform workers that the employer is temporarily suspending the annual fit testing of N95 filtering facepiece respirators to preserve and prioritize the supply of respirators for use in situations where they are required to be worn."  P. Ex. 3 at 3.

The publication, however, also includes the requirement that the employer "[p]erform initial fit tests for each HCP [Health Care Provider] with the same model, style, and size respirator that the worker will be required to wear for protection against COVID-19 (initial fit testing is essential to determine if the respirator properly fits the worker and is capable of providing the expected level of protection)."  P. Ex. 3 at 3.  Thus, while the OSHA publication suspends the annual fit testing for the N95 respirators, the publication does not relax the requirement that the employer perform the initial fit test.  I also note that the guidance further states:  "Where the use of respiratory protection is required and an employer fails to comply with any other requirements, *such as initial fit testing*, maintenance, care, and training in the Respiratory Protection standard, cite the applicable section(s) of 29 C.F.R. § 1910.134."  P. Ex. 3 at 3 (emphasis added).  Petitioner does not dispute that it did not perform initial fit testing of the N95 respirator masks for its employees.

Page 11

**c. Petitioner's Alternative Request to Reduce Scope and Severity to Level D**

If the citation is not removed, Petitioner requests reduction of the citation's scope and severity to "D."  P. Br. at 2.  In support of this request, Petitioner submitted an OSHA document entitled "Enforcement Guidance for Respiratory Protection and the N95 shortage Due to the Coronavirus Disease 2019 (COVID-19) Pandemic" (April 3, 2020).  P. Br. at 4 (citing P. Ex. 6).  OSHA issued this document as additional guidance following the guidance issued on March 14, 2020, discussed above.  P. Ex. 6 at 2.

In the April 3 guidance, OSHA confirmed that because of the shortage of N95 respirators, health care employers could consider use of alternative classes of respirators that provide equal or greater protection to an N95 facepiece respirator, as well as extended use or reuse of the N95 respirators.  P. Ex. 6 at 3.  The publication provides that OSHA will, on a case-by case basis, exercise enforcement discretion when considering citations under 29 C.F.R. § 1910.34(d) and/or the equivalent respiratory protection provisions of other health standards in cases where the employer has taken specific actions.  P. Ex. 6 at 5.  These actions include:

The employer's having made a good faith effort to obtain other alternative filtering respirators, reusable elastomeric respirators, or powered air purifying respirators (PAPRs);
	The employer has monitored the supply and use of N95 respirators;
	Surgical masks and eye protection have been used in the interim; and
	The employer has used other feasible measures that would reduce the need for respiratory protection.P. Ex. 6 at 5.  While the publication details specific instructions with respect to expired N95 respirator masks, extended use of N95 respirator masks, and reuse of the N95 respirator masks, the publication does not include a waiver for the initial fitting of the N95 respirator masks.  P. Ex. 6, *passim.*

Petitioner also argues that Tag F 880 does not require fit testing specifically or even the use of N95s.  P. Br. at 7 (citing State Operations Manual, CMS Pub. 100-07, Appendix PP at 673).8
  Petitioner is correct that regulation 42 C.F.R. § 483.80 governing infection

Page 12

control does not include a specific reference to N95 respirator masks or fit testing for the masks.9
  The regulation provides that a "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."  42 C.F.R. § 483.80.  The regulation further requires a facility to establish an IPCP that must include written standards, policies, and procedures for the program including "[s]tandard and transmission‐based precautions to be followed to prevent the spread of infections."  42 C.F.R. § 483.80(a)(2)(iii).

The record contains Petitioner's respiratory protection program, captioned as "Avamere Living Respiratory Protection Program for use by Healthcare Facilities."  CMS Ex. 7.  The program specifically refers to the OSHA regulations that require fit testing for respirators.  CMS Ex. 7 at 2 (citing 29 C.F.R. § 1910.134(c), DOSH Directive 11.80)).  This program specifies that all employees designated to use fit tested filtering facepiece respirators (FFR) will be fit tested before using their respirator.  CMS Ex. 7 at 4-5.  The fit tested protocol is attached as Appendix A.  CMS Ex. 7 at 7-13.  Petitioner's COVID‐19 Infection Control Manual also provides that in areas designated for Observation-Quarantine Precautions, everyone, including visitors, doctors, and staff, must wear mask and eye protection and specifically states that "[f]it tested N-95 disposable respirators or higher [are] required with aerosolizing procedures."  P. Ex. 15 at 23.  Thus, Petitioner's respiratory protection program and its COVID-19 Infection Control Manual include the requirement for initial fit testing for employees using the N95 respirator mask.

Petitioner further argues that "there was no realistic potential for widespread harm (level F) as opposed to potential for isolated harm (level D)."  Specifically, Petitioner submits that by January 22, 2021, and after almost a year of serving as a COVID-19 Recovery Unit, there was "not a single outbreak or infection . . . which was facility based."  Petitioner maintains that there was a very limited potential for harm, given Petitioner's success rate in infection control practices.  P. Br. at 8.

As the Petitioner asserts, CMS has not submitted any proof that Petitioner's failure to fit test employees for the N95 respirator masks resulted in an outbreak or infection that was facility based.  However, contrary to Petitioner's suggestion, proof that a deficiency caused actual harm is not a prerequisite to finding a lack of compliance with program

Page 13

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.  *North Las Vegas Care Ctr*., DAB No. 2946 at 9 (2019) (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)).

Despite Petitioner's assertions, I cannot reduce the citation's scope and severity level as Petitioner requests.  First and foremost, an ALJ may review CMS's scope and severity findings only if a successful challenge would affect:  (1) the range of the CMP amount that CMS could collect; or (2) a finding of substandard quality of care that results in the loss of approval of a facility's Nurse Aide Training and Competency Evaluation Program (NATCEP).  42 C.F.R. § 498.3(b)(14).  Neither of these criteria apply in this case.

**4. I do not have authority to grant equitable relief.**

While Petitioner seeks removal of the Tag F 880 citation or a reduction of the scope and severity level in the alternative, Petitioner does not specifically request equitable relief.  Without doubt, if equitable relief were available to Petitioner, I would grant it.

There is no dispute that in April 2020, and at the beginning of the pandemic, Petitioner contracted to accept and provide care for COVID-19 patients, and in doing so provided relief to local hospitals and other facilities in Pierce County, Washington.  P. Ex. 1 at 2 ¶ 5 (Fisher Decl.).  CMS does not dispute that Petitioner agreed to provide a much‐needed service at a critical time in the pandemic.  Furthermore, CMS does not dispute that at the time that Petitioner was selected to be a COVID-19 Recovery Unit, Petitioner was short on N95 masks and had not been able to obtain fit testing due to the demand and short supply.  P. Ex. 1 at 2 ¶ 5 (Fisher Decl.).  The record also reflects that the CMS contractor completed a COVID-19 infection control survey on April 23, 2020, and issued no citations, despite Petitioner's shortage of N95 respirator masks and an absence of fit testing for the masks being used.  P. Ex. 4 at 1.  On June 24, 2020, DSHS again conducted a COVID-19 infection control survey at Petitioner's facility.  DSHS found no deficiencies, even though Petitioner had not secured fit testing for the N95s being used.  P. Ex. 8 at 1.  CMS disputes neither of these determinations.  Petitioner's Administrator Tonya Fisher also testified, without contradiction, that from August 2020 until January 2021, Petitioner continued to work to obtain fit test kits and to secure a qualified vendor to conduct fit tests.  P. Ex. 1 at 2 ¶¶ 8-9.   Fisher further testified that as of January 11, 2021, Petitioner was finally given a date on which fit testing would be provided, and the testing was scheduled for January 25, 2021.  P. Ex. 1 at 3 ¶ 11.  At the time of the unannounced survey on January 15, 2021, Fisher provided the DSHS with documentation of all prior attempts to obtain fit testing as well as documentation to

Page 14

confirm the scheduled fit testing for January 25, 2021.  P. Ex. 1 at 3 ¶¶ 12-13 (Fisher Decl.).

As the above discussion reflects, although Petitioner provided proof of its previous attempts to obtain fit testing and its proof that the fit testing was scheduled for January 25, 2021, DSHS issued a citation on January 22, 2021.  It is disturbing that DSHS issued this citation only three days before the scheduled testing.  Furthermore, the circumstances on which DSHS based its citation were present at the time of two previous inspections and, more importantly, also at the time that DSHS contracted with Petitioner to be a COVID-19 Recovery Unit.  Nevertheless, Petitioner's employees were not fit tested for the N95 respiratory masks on January 15, 2021.  Because DSHS, as the CMS contractor, acted within its authority to impose a DPOC for noncompliance, I do not have the authority to overturn its lawful use of its regulatory authority based on principles of equity.  *Cent. Kan. Cancer Inst.*, DAB No. 2749 at 10 (2016).  More succinctly, when CMS acts within the scope of its regulatory authority, I may not substitute my discretion because of fairness or other equitable grounds.  *See James Shepherd*, *M.D.,* DAB No. 2793 at 9 (2017); *US Ultrasound,* DAB No. 2302 at 8 (2010).

VI.  Conclusion

For the foregoing reasons, I affirm the deficiency cited and grant CMS's motion for summary judgment.


          /s/
        Margaret G. Brakebusch

                      Administrative Law Judge
      1. Medicare participation deficiencies are measured by the scope and severity of the deficient practice.  A scope and severity of "F" is a widespread deficiency that does not cause actual harm, but has the potential for more than minimal harm. back to note 1
                      2. The N95 respirators are also referenced as N95 masks or N95 respirator masks. back to note 2
                      3. The case was initially assigned to a different ALJ and was later transferred to the undersigned. back to note 3
                      4. Petitioner submitted two different documents filed as its Exhibit 4.  Compare DAB E- File #s 12 and 14. back to note 4
                      5. My findings of fact and conclusions of law appear as headings in bold italic type. back to note 5
                      6. Petitioner's brief is not paginated.  I cite to the PDF counter number for page citations. back to note 6
                      7. A Level D deficiency is isolated in scope with no actual harm but the potential for more than minimal harm. back to note 7
                      8. CMS online manuals are located at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs (last visited March 23, 2022). back to note 8
                      9. OSHA regulation 29 C.F.R. § 1910.134(c)(1)(iii) requires that when a written respiratory protection program is in place and where respirators are required or necessary to protect the health of the employee, the protection program shall include fit testing for tight-fitting respirators. back to note 9 Back to top
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