Valley View Manor Healthcare Center, DAB CR6689 (2025)

DECISION

Petitioner, Valley View Manor Healthcare Center, challenges the determination by Respondent, the Centers for Medicare & Medicaid Services (CMS), that it was not in substantial compliance with two Medicare program participation requirements.  Petitioner also challenges CMS’s imposition of civil money penalties (CMPs) totaling $248,885 as unreasonable.

As explained herein, I deny Petitioner’s cross-motion for summary judgment, grant CMS’s motion for summary judgment, affirm the basis for CMS’s imposition of penalties, and find the CMP amounts selected by CMS reasonable.

I.     Background

Petitioner is a skilled nursing facility located in Lamberton, Minnesota that participates in the Medicare program.  CMS Exhibit (Ex.) 2 at 1.  On November 5, 2020, the Minnesota Department of Health (MDH or state agency) conducted a COVID-19 Focused Infection Control survey at Petitioner’s facility.  CMS Ex. 1 at 1; CMS Ex. 2 at 1.  The state agency found Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1),(2),(4); (e); (f) (Tag F880) and 42 C.F.R. § 483.80(b)(1)-(4)(c)

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(Tag F882), both at scope and severity1 (s/s) level “F.”  CMS Ex. 2 at 1.  On November 20, 2020, MDH notified Petitioner it would impose a directed plan of correction (DPOC) as well as deny payments for new Medicare and Medicaid Admissions (DDPNA) as of January 4, 2021.  CMS Ex. 1 at 1.

MDH completed another COVID-19 Focused Infection Control Survey on November 25, 2020.  CMS Ex. 20.  It again found Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1),(2),(4); (e); (f), this time at s/s level “L,” meaning the facility’s noncompliance posed an immediate jeopardy to resident health or safety on a widespread basis.  See id.  The state agency determined this deficiency abated from the level of immediate jeopardy on November 25, 2020 but persisted at a lower level of severity.  Id. at 4.  On December 15, 2020, MDH notified Petitioner it would impose a DPOC as well as a DDPNA that would go into effect on January 4, 2021.  CMS Ex. 1 at 12.

On December 16, 2020, MDH completed another COVID-19 Focused Infection Control Survey at Petitioner’s facility and again found Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1),(2),(4); (e); (f), this time at s/s level “E.”  CMS Ex. 32.  On January 5, 2021, MDH notified Petitioner it would impose another DPOC and that the previously imposed DDPNA took effect on January 4, 2021.  CMS Ex. 1 at 26, 29.  On February 10, 2021, MDH notified Petitioner of its finding that it had returned to substantial compliance on February 4, 2021, the date MDH completed a revisit survey at the facility.  Id. at 41.

On April 29, 2021, CMS sent Petitioner a notice summarizing the survey findings for the survey cycle beginning November 5, 2020 as well as the penalties already imposed by the state agency, namely three DPOCs (effective December 5, 2020, December 30, 2020, and January 20, 2021) and the DDPNA that began January 4, 2021.  CMS Ex. 2 at 1-2.  CMS advised Petitioner it determined the facility returned to substantial compliance on February 4, 2021.  Id. at 2.  As a result, CMS explained the DDPNA applied to admissions from January 4, 2021 through February 3, 2021.  Id.  CMS also prohibited Petitioner from offering or conducting a Nurse Aide Training and/or Competency

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Evaluation Program (NATCEP) for two years, effective January 4, 2021.  Id. at 4.  Finally, CMS notified Petitioner it would impose CMPs based on the above deficiencies as follows:

• a $20,000 per-instance CMP for the deficiency identified during the survey ending November 5, 2020
• an $11,000 per-day CMP for the immediate jeopardy-level deficiency identified during the survey ending November 25, 2020 that lasted from November 7 through November 24, 2020
• and a $435 per-day CMP for the noncompliance that persisted after removal of the immediate jeopardy, lasting from November 25, 2020 through February 3, 2021.

Id. at 2-3.  CMS imposed a total CMP of $248,885.  Id. at 3.

Petitioner timely sought a hearing before an Administrative Law Judge (ALJ) in the Civil Remedies Division to challenge the determinations of noncompliance resulting from MDH’s surveys and the remedies imposed by MDH and CMS, resulting in my designation to hear and decide this case.  I issued an Acknowledgment and Pre-hearing Order (Pre-hearing order) that established a briefing schedule and directed the parties to file pre-hearing submissions that included written direct testimony for all proposed witnesses, proposed exhibits, and pre-hearing briefs.

On September 7, 2021, CMS filed a motion for summary judgment and pre-hearing brief in support (CMS Br.) and 46 proposed exhibits (CMS Exs. 1-46), including written direct testimony for two witnesses.  On October 12, 2021, Petitioner filed a cross-motion for summary judgment and pre-hearing brief in support (P. Br.) and 16 proposed exhibits (P. Exs. 100-115),2 including written direct testimony for three witnesses.  Petitioner also requested to cross-examine CMS’s witnesses.  On October 27, 2021, CMS filed a response to Petitioner’s cross-motion for summary judgment (CMS Resp.), an objection to one of Petitioner’s proposed exhibits (CMS Obj.), and a request to cross-examine Petitioner’s witnesses.

II.     Admission of Exhibits

Absent objections from Petitioner, I admit CMS Exhibits 1 through 46 into evidence.

CMS objects to P. Ex. 115, the declaration of Petitioner’s witness Samuel D. Orbovich, on the grounds of relevance.  CMS Obj. at 1.  Orbovich declares that CMS’s motion for

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summary judgment should be denied because there are “material facts in controversy over whether [MDH’s] sanctions under appeal in this matter are based in evidence or may be in retaliation” for prior allegations of bias raised by him in 2018 and 2019.  P. Ex. 115 at 4.

CMS argues Orbovich’s testimony is irrelevant because it “points to statements and Facebook posts of state agency employees that [Petitioner] acknowledges were not involve[d] in the surveys at issue in this case.”  CMS Obj. at 1.  CMS contends Petitioner has not established the questions Surveyor Boerboom allegedly posed six years earlier affected the surveys at issue before me.  Id.  CMS also points out MDH’s determination of immediate jeopardy resulted from the November 25, 2020 survey in which Surveyor Boerboom did not even participate.  Id.

CMS makes persuasive arguments as to the weight I should give Orbovich’s declaration, but its attacks do not amount to a showing of irrelevance that would preclude its admissibility.  I overrule CMS’s objection and admit Petitioner’s Exhibits 100 through 115 into evidence.

III.     Issues

A.  Whether summary judgment is appropriate;

B.  Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.80(a)(1),(2),(4); (e); (f) (Tag F880) at the time of the November 5, November 25, and December 16, 2020 surveys;

C.  If Petitioner was not in substantial compliance at the time of the November 25, 2020 survey, whether CMS’s immediate jeopardy determination was clearly erroneous; and

D.  If Petitioner was not in substantial compliance, whether the CMPs imposed by CMS are reasonable.

IV.     Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

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V.     Legal Authority for the Imposition of Penalties

Skilled nursing facilities like Petitioner must meet requirements set forth by the Act to participate in the Medicare program.  The Secretary of the U.S. Department of Health and Human Services (Secretary) is authorized to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  These regulations are found at 42 C.F.R. pts. 483 and 488.

A skilled nursing facility must maintain substantial compliance with program requirements to participate as a provider in the program.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against skilled nursing facilities that do not comply with the participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The Secretary may impose CMPs if a facility is not in substantial compliance.  Act § 1819(h)(2)(B)(ii) (42 U.S.C. § 1395i-3(h)(2)(B)(ii)); see also 42 C.F.R. § 488.406.  Regulations implemented by CMS under this authority permit the agency to impose either a per-day CMP for the number of days a facility is out of substantial compliance or a per-instance CMP for each instance of noncompliance.  42 C.F.R. § 488.430(a).

CMS imposed both per-instance and per-day CMPs in this case.  A per-instance CMP initially ranged from $1,000 to $10,000.  42 C.F.R. § 488.438(a)(2).  However, Congress permitted CMS to increase CMP amounts to account for inflation beginning August 1, 2016.  Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Pub. L. No. 114-74, 129 Stat. 584, 599; see also 42 C.F.R. § 102.3 (Table).  The adjusted CMP amounts apply to deficiencies cited after November 2, 2015, and are thus applicable here.  81 Fed. Reg. 61,538 (Sep. 6, 2016).  When CMS imposed the CMP at issue here, a per-instance CMP could range from $2,233 to $22,320.  42 C.F.R. § 102.3 (Table); 85 Fed. Reg. 2,869, 2,879-80 (Jan. 17, 2020).

CMS may also impose a per-day CMP for the number of days a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  Before adjustments for inflation, a per-day CMP ranges from $50 to $3,000 per-day for less serious noncompliance, or $3,050 to $10,000 per-day for more serious noncompliance that poses an immediate jeopardy to the health and safety of residents.  42 C.F.R. § 488.438(a)(1).  When CMS imposed the per-day CMPs at issue here, a per-day CMP could range from $112 to $6,695 for less serious noncompliance, or $6,808 to $22,320 per day for immediate jeopardy-level noncompliance.  42 C.F.R. § 102.3 (Table); 85 Fed. Reg. 2,879-80.

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A facility against whom CMS has imposed a CMP may request a hearing before an ALJ to challenge the basis for the deficiency findings as well as the reasonableness of the CMP.  Act §§ 1128A(c)(2) (42 C.F.R. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 C.F.R. § 1395i(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, CMS’s choice of remedies and the factors it considered when deciding upon remedies are not subject to review.  42 C.F.R. § 488.408(g)(2).

VI.     Burdens of proof and persuasion

In adjudications proceeding under the Administrative Procedures Act (APA), Congress established that “the proponent of a rule or order has the burden of proof[,]” except where otherwise provided by statute.  5 U.S.C. § 556(d).  The Act does not “otherwise provide[]” for allocation of the burden of proof or the quantum of evidence necessary to meet that burden in this type of proceeding.  It would therefore be reasonable to conclude that CMS, the agency that propounded the regulations implementing its enforcement authority under the Act, bears the burden of proof and persuasion to justify imposition of penalties authorized by the Act.

Nevertheless, the Departmental Appeals Board has imposed a burden-shifting regime in cases involving the imposition of enforcement penalties against providers whose appeals are adjudicated under 42 C.F.R. Part 498.  Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); VITAS Healthcare Corp. of Calif., DAB No. 1782 at 4 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998) (applying the burden-shifting regime to cases involving skilled nursing facilities); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

Under that regime, CMS has the burden to come forward with evidence sufficient to make a prima facie showing3 it had a basis to impose a penalty.  In Hillman, an appeal by a rehabilitation center of its termination as a provider to the Medicare program by the Health Care Finance Administration (CMS’s predecessor agency), the Board identified the elements it believed necessary for CMS to make such a showing:

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[CMS] must identify the legal criteria to which it seeks to hold a provider.  Moreover, to the extent that a provider challenges [CMS’s] findings, [CMS] must come forward with evidence of the basis for its determination, including the factual findings on which [CMS] is relying and, if [CMS] has determined that a condition of participation was not met, [CMS’s] evaluation that the deficiencies found meet the regulatory standard for a condition-level deficiency.

DAB No. 1611 at 8.

Once CMS makes a prima facie showing of noncompliance, the Board held the facility bears “the ultimate burden of persuasion” and can only prevail if it proves, by a preponderance of the evidence of record, that it substantially complied with statutory and regulatory requirements.  Id. at 7.

Subsequently, a skilled nursing facility appealed CMS’s imposition of a CMP for failing to substantially comply with Medicare participation requirements and argued burden-shifting would be improper in hearings proceeding under the APA.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

The Board rejected this claim, explaining the Supreme Court approved placing the burden of proof “on the claimant for governmental benefits when evidence is evenly balanced” because the party seeking the benefit, including a “non-monetary benefit or privilege,” would, in that context, be “the proponent of the rule or order.”  Batavia Nursing, DAB No. 1911 at 10 (citing Director, OWCP v. Greenwich Collieries, 512 U.S. 267, 276 (1994); U.S. Steel Corp. v. Train, 556 F.2d 822, 834 (7th Cir. 1977) (the applicant for a permit to discharge pollutants is a “proponent”); Day v. NTSB, 414 F.2d 950, 952 (5th Cir. 1969) (finding it appropriate to place the burden of proof on a pilot seeking certification of fitness to fly).

The Board reasoned that by appealing the penalties imposed by CMS, Batavia Nursing in essence sought “from the government an order certifying that it is in substantial compliance with [skilled nursing facility] requirements, so that it may continue to participate in the Medicare program with no restrictions on payment.”  DAB No. 1911 at 10.  The Board therefore concluded it reasonable to place the burden of proof on Batavia to show its return to substantial compliance.  Id.

The legitimacy of the burden-shifting regime thus rests largely on the Board’s characterization of facilities as proponents of a rule or order because they seek a certification of substantial compliance with Medicare program participation rules, even though the jurisdiction of ALJs and the Board to hear such challenges is limited

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exclusively to circumstances where CMS opts to impose a penalty.4  42 C.F.R. § 488.408(g)(1) (“A facility may appeal a certification of noncompliance leading to an enforcement remedy.”); 42 C.F.R. § 498.3(b)(13); Columbus Park Nursing & Rehab. Ctr., DAB No. 2316 at 7 (2010) (a facility cannot contest survey deficiency findings unless CMS has imposed a remedy).

To date, federal district and circuit courts have declined to disturb the burden-shifting regime on due process or other grounds.  See, e.g., Hillman Rehab. Ctr., DAB No. 1611 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs., No. Civ. A. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff’d, Fairfax Nursing Home, Inc. v. U.S. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 2003 WL 98478 (Jan. 13, 2003); Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004), aff’d sub nom., Batavia Nursing & Convalescent Ctr. v. Thompson, 143 F. App’x 664 (6th Cir. 2005).

However, the Supreme Court has since examined the scope of the Secretary’s rulemaking authority in the context of Medicare reimbursement and held that under section 1871 of the Act, the Secretary must comply with notice-and-comment rulemaking under the APA to impose any requirements upon regulated entities which constituted a change in a substantive legal standard.  Azar v. Allina Health Servs., 587 U.S. 566, 139 S. Ct. 1804 at 1809-14 (2019).

The Court has also renounced its longstanding interpretive rule, commonly referred to as Chevron deference, which required courts reviewing agency actions to defer to agencies’ interpretation of their statutory mandate where the language of the statute in question was ambiguous.  See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 144 S. Ct. 2244 (2024); Hillman Rehab. Ctr., DAB No. 1611 at 17-20 (justifying burden-shifting in part by noting it was consistent with the “long-standing interpretation” of the Board’s predecessor body).

It remains to be seen whether federal courts will consider the Board’s burden-shifting regime a “change in a substantive legal standard” under the Allina holding or, in the absence of Chevron deference, more broadly reject the Board’s interpretation of section 7 of the APA to identify entities challenging enforcement actions taken by the government as proponents of an order or rule.  Until such judicial scrutiny demands otherwise, and

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absent modification of the Act or CMS’s implementing regulations, I apply the Board’s burden-shifting regime.

VII.     Standard for summary judgment

Summary judgment is appropriate in cases where 42 C.F.R. Part 498 applies if there is no genuine dispute of any material fact and the moving party is entitled to judgment as a matter of law.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 750 (6th Cir. 2004); Civ. Remedies Div. P. § 19(a).  A “genuine” dispute exists if “the evidence is such that a reasonable [trier of fact] could return a verdict for the nonmoving party,” (Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)), and a “material” fact is one “that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010).

To obtain summary judgment, the moving party must show it is entitled to judgment as a matter of law because there is no genuine dispute of material fact requiring an evidentiary hearing to resolve.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012).  If the moving party meets this initial 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).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact — a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab., DAB No. 2300 at 3.

In evaluating a motion for summary judgment, an ALJ does not address credibility or evaluate the weight of conflicting evidence.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an ALJ must draw all reasonable inferences in the light most favorable to the non-moving party.  See Brightview Care Ctr., DAB No. 2132 at 10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable).  “[A]t the summary judgment stage[,] the 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. 242, 249 (1986).  Drawing factual inferences in the light most favorable to the non-moving party does not require me to accept the non-moving party’s legal conclusions.  Cedar Lake Nursing Home, DAB No. 2344 at 7 (2010).

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VIII.     Discussion

A.   Legal Framework for Infection Prevention and Control

The Act and its implementing regulation require facilities like Petitioner to “[e]stablish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection[.]”  42 U.S.C. § 1395i-3(d)(3)(A); 42 C.F.R. § 483.80.  At minimum, a facility’s infection control policy must satisfy the following requirements:  

(a)  Infection prevention and control program.  The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:

(1)  A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards; 

(2)  Written standards, policies, and procedures for the program, which must include, but are not limited to:

(i)  A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;

(ii)  When and to whom possible incidents of communicable disease or infections should be reported;

(iii)  Standard and transmission-based precautions to be followed to prevent spread of infections;

(iv)  When and how isolation should be used for a resident; including but not limited to:

(A)  The type and duration of the isolation, depending upon the infectious agent or organism involved, and

(B)  A requirement that the isolation should be the least restrictive possible for the resident under the circumstances. 

(v)  The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

(vi)  The hand hygiene procedures to be followed by staff involved in direct resident contact.

*        *        * 

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(4)  A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility. 

*        *        *

(e)  Linens.  Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.  

(f)  Annual review.  The facility will conduct an annual review of its IPCP and update their program, as necessary. 

42 C.F.R. §§ 483.80(a)(1), (a)(2), (a)(4); (e); (f). 

Beyond prescribing the presence of these elements, the regulation does not mandate specific standards and measures but instead grants facilities discretion to develop and implement infection control protocols consistent with “accepted national standards” for infection control.  42 C.F.R. § 483.80(a)(1); Golden Living Ctr. – Superior, DAB No. 2768 at 7-8 (2017).  Upon establishing such policies and protocols, a facility must implement those protocols and assure they are effective.  Id.  A facility is not in substantial compliance with participation requirements when it fails to follow standard precautions and isolation control procedures specified in its own infection control policies.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13 (2014).

B.   Undisputed Facts

1. CDC Guidance

In August 2020, the Centers for Disease Control and Prevention (CDC) updated guidelines it issued providing criteria for when healthcare personnel could return to work after a confirmed COVID-19 infection or a suspected infection for which the individual had not been tested.  CMS Ex. 41 at 1.

Facilities could apply a symptom-based approach, under which healthcare personnel with mild to moderate illness without severe immunocompromise could return to work after 10 days had passed since their symptoms first appeared, or 24 hours after their last fever without the use of fever-reducing medications and improved symptoms.  Id. at 2.

Facilities could also employ a test-based approach to allow healthcare personnel to return to work in less time than under the symptom-based approach, though the CDC observed the utility of this approach would be limited because of the prolonged viral shedding period some people would experience.  Id.

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The CDC recommended healthcare personnel returning to work wear a facemask at all times inside a healthcare facility until their symptoms resolved or returned to baseline.  Id. at 3.  It also advised healthcare workers to self-monitor for symptoms and seek re-evaluation if their symptoms returned or worsened.  Id.

In November 2020, the CDC updated guidance it issued to prepare nursing homes for COVID-19.  CMS Ex. 43.  The CDC advised nursing facilities to maintain the “core practices” facilities would apply in normal circumstances.  Id. at 1.  These included:

• Assigning one or more individuals with training in infection control to provide on-site management of the infection and prevention control program;
• Report COVID-19 cases, facility staffing, and supply information to the National Healthcare Safety Network Long-term Care Facility COVID-19 module on a weekly basis;
• Educate residents, healthcare personnel, and visitors about COVID-19, current precautions being taken in the facility, and actions they should take to protect themselves;
• Implement source control measures;
• Have a plan for visitor restrictions;
• Create a plan for testing residents and healthcare personnel for the COVID-19 virus;
• Evaluate and manage healthcare personnel;
• Provide supplies necessary to adhere to recommended infection prevention and control practices;
• Identify space in the facility that could be dedicated to monitor and care for residents with COVID-19;
• Create a plan for managing new admissions and readmissions whose COVID-19 status is unknown; and
• Evaluate and manage residents with symptoms of COVID-19.

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CMS Ex. 43 at 2-5.  The CDC identified additional strategies that could be used depending on a facility’s reopening status and noted employment of these strategies would depend on the stages described in CMS’s reopening guidance or the directives of state and local officials.  Id. at 6.

Lastly, the CDC issued guidance for the discontinuation of transmission-based precautions for patients with confirmed COVID-19 infection.  CMS Ex. 44.  The CDC advised the “decision to discontinue transmission-based precautions for patients with confirmed SARS-COV-2 infection should be made using a symptom-based strategy.”  Id. at 1.  The CDC described the same symptom-based strategy it provided in its guidance concerning when healthcare personnel could return to work after a COVID-19 infection.  CMS Ex. 41 at 2; CMS Ex. 44 at 1-2.

2. Valley View’s policies

At the time of the survey, Petitioners’ relevant policies were embodied in its COVID-19 Facility Guidelines, COVID-19 Facility Testing Guidance, and Surveillance for Infections policy.  See CMS Ex. 45.

1. Environmental procedures

Petitioner’s COVID-19 Facility Guidelines identified procedures for visits and screening, environment, employees, and resident care and surveillance.  Id. at 1-4.  This included the following “environment” procedural requirements:  all exterior doors to be locked from the outside and access to the facility limited to a single access point; all high-touched surfaces to be sanitized at least twice a day; vendors to leave all deliveries outside; the distribution and implementation of a communal dining policy for communal dining and activities; the creation of a COVID wing or unit and designation of assigned staff; thorough terminal cleaning of COVID and quarantine rooms with destruction of used and unused personal care items; and performance of infection control audits on a weekly and as-needed basis.  Id. at 1.

2. Employee conduct

Petitioner’s COVID-19 Facility Guidelines also set forth standards and practices for its employees to mitigate the spread of virus within the facility.  Id.  The policy required all staff to be screened by another employee before each shift with mandated screening questions and logging of temperatures taken during screening.  Id. at 2.  It required an employee with a temperature exceeding 99.0 degrees Fahrenheit be sent home.  Id.  Petitioner’s policy stated the facility would “follow the CDC[’s] guidance for optimization of [personal protective equipment (PPE)] and donning/doffing of PPE.”  Id.  It also obliged the facility to follow MDH and CDC guidelines to determine when employees diagnosed with COVID-19 could return to work and affirmed the facility

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would implement isolation precautions in accordance with CDC guidelines and its own policy and procedures.  Id.  Petitioner’s policy required the facility to maintain a list of members of staff who worked in other facilities and keep track of outbreaks occurring in those facilities.  Id.

3. Resident care and surveillance

Petitioner’s policy indicated the facility would continue surveillance of all residents for COVID-19 infection, which required staff to use the “Existing Resident COVID-19 Screening Tool,” measure residents’ temperatures and O2 saturation levels, and complete additional screening questions.  Id.  The policy required staff to do so at least once a day if there were no known cases of COVID-19 and twice per day if the facility had known cases of COVID-19.  Id.  It also required facility staff to check signs and symptoms three times a day, once per shift, for COVID-19 positive residents or those under investigation.  Id.  It otherwise provided that when possible, the facility would screen every resident every shift, regardless of infection status.  Id. at 3.

Petitioner’s resident care policy also required staff to:  limit family visits to phone or video chats; discourage residents from leaving the facility by educating them about the risk of spreading COVID-19; encourage residents to use face masks and document refusal to do so in their medical charts; and apply American Health Care Association and MDH guidelines for the admission and readmission of residents.  Id.  Petitioner’s policy required staff to immediately place a resident suspected to have COVID-19 on droplet precautions, place a mask on the resident, close their door, and contact MDH, the assigned regional clinician, and the local hospital.  Id.  It also required facility staff to notify the resident’s representative, physician, guardian if applicable, and any other provider treating the resident.  Id.

Petitioner’s policy required placing a PPE station and appropriate signage at the door of affected residents’ rooms for a 14-day quarantine period.  Id.  The policy also required staff to test the resident for COVID-19 two to three days before the end of the quarantine period and clinically assess the resident before discontinuing quarantine.  Id. at 3-4.

4. Testing

Petitioner’s COVID-19 Facility Testing Guidance required screening of “[a]ll visitors, staff, vendors, contractors and residents . . . per facility screening guidance.”  Id. at 5.  This included all facility employees as well as consultants, caregivers, hospice personnel, and students who frequented the facility weekly.  Id.  The policy did not require vendors to be tested but required the facility to screen them and provide a facemask.  Id.

Petitioner’s policy required any resident or member of staff who showed symptoms or signs of COVID-19 to be tested.  Id.  In the event of an outbreak, the policy required the

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facility to test all staff and residents who previously tested negative until no new cases were identified.  Id.  Otherwise, the policy required routine testing of staff based on the extent of the virus in the community reflected in positivity rates in data provided by CMS.  Id. at 5-6.  Low community activity, defined as a less than 5% county positivity rate, required testing at least once a month.  Id. at 6.  Medium community activity, meaning a 5 to 10% county positivity rate, required weekly testing of staff.  Id.  High community activity referred to a county positivity rate greater than 10% and required testing twice a week.  Id.

5. Infection Surveillance

Petitioner’s infection surveillance policy provided the framework by which the facility’s Infection Preventionist would track “Healthcare-Associated infections (HAIs) and other epidemiologically significant infections . . . .”  Id. at 8.  The policy defined surveillance to include review of laboratory records, skin care sheets, infection control rounds or interviews, verbal reports from staff, infection documentation records, temperature logs, pharmacy records, antibiotic review, and transfer log summaries.  Id. at 9.

For targeted surveillance using facility-created tools, the policy set forth frequency-based reporting parameters.  It required daily recording of detailed information for infected residents using an individual infection report form.  Id. at 10.  On a monthly basis, the facility would collate information from individual infection reports and summarize that data by unit, site, and pathogen.  Id.  On a monthly to quarterly basis, the policy required facility staff to identify and record “predominant pathogens” or infection sites among residents or units to observe trends.  Id.  It also required the facility to compare current incidents of infection to data from a prior time period as a baseline to identify possible increases in infection rates.  Id.

3. The November 5, 2020 survey

MDH conducted a COVID-19 Focused Infection Control survey at Petitioner’s facility from November 4, 2020 to November 5, 2020.  CMS Ex. 4.  As a result of that survey, Surveyor Angela Hatch identified seven instances from August through October 2020 she believed demonstrated Petitioner did not comply with its own policy or CDC guidelines regarding the return to work of staff after they reported COVID-19 symptoms:

• Nurse Aide 1 (NA1) reported vomiting on August 11, 2020 and returned to work on August 12, 2020.  CMS Ex. 4 at 4; CMS Ex. 6 at 1.  The facility did not document testing NA1 for COVID-19 in its employee illness log.  CMS Ex. 6 at 1.
• NA1 reported vomiting on August 15, 2020 and returned to work on August 17, 2020.  CMS Ex. 6 at 1; CMS Ex. 4

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at 4.  The facility did not document testing NA1 for COVID-19 in its employee illness log.  CMS Ex. 6 at 1.

• Nurse Aide (NA2) reported nausea on September 17, 2020 and returned to work on September 18, 2020.  CMS Ex. 6 at 2; CMS Ex. 4 at 4.  The facility did not document testing NA2 for COVID-19 in its employee illness log.  CMS Ex. 6 at 2.
• Registered Nurse (RN1) reported a fever and headache on September 24, 2020 and returned to work on September 25, 2020.  CMS Ex. 4 at 4-5; CMS Ex. 6 at 2.  The facility did not document a negative COVID-19 test for RN1 or whether RN1’s fever had resolved prior to returning to work.  CMS Ex. 6 at 2.
• Laundry Aide (LA1) reported nausea and vomiting on September 30, 2020 and returned to work on October 6, 2020.  CMS Ex. 4 at 5; CMS Ex. 6 at 2.  The facility did not document testing LA1 for COVID-19 in its employee illness log.  CMS Ex. 6 at 2.
• NA2 reported vomiting and diarrhea on October 19, 2020 and returned to work on October 20, 2020.  CMS Ex. 4 at 5; CMS Ex. 6 at 3.  The facility did not document testing NA2 for COVID-19 in its employee illness log.  CMS Ex. 6 at 3.
• NA1 reported vomiting on October 24, 2020 and returned to work on October 25, 2020.  CMS Ex. 4 at 5; CMS Ex. 6 at 3.  The facility did not document testing NA1 for COVID-19 in its employee illness log.  CMS Ex. 6 at 3.

CMS Ex. 4 at 3-5; CMS Ex. 17 ¶¶ 7-8.

Surveyor Hatch also identified eight instances she believed demonstrated Petitioner did not follow its own policy concerning the surveillance of residents for infection by failing to record precautions used for residents or document data collection by the Infection Preventionist to determine the effectiveness of those precautions:

• In August 2020, Petitioner did not document precautions employed for Residents 1 and 42 after they were either exposed to or showed symptoms of COVID-19.  CMS Ex. 7 at 1.
• In September 2020, Petitioner failed to record precautions employed for Residents 32, 40, 25, 9, and 43, all of whom received COVID-19 tests.  Id. at 2.

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• In October 2020, the facility similarly failed to record precautions used for Resident 22, who received a COVID-19 test.  Id. at 4.

CMS Ex. 17 ¶¶ 12-14; CMS Ex. 4 at 6-7; CMS Ex. 45 at 8.

Surveyor Hatch also identified six instances Petitioner failed to meet its obligation to fully collect COVID-19 data by failing to identify residents it suspected of having COVID-19, evidenced by the fact that the facility administered COVID-19 tests to them:

• Resident 42 took a COVID-19 test after being exposed to the virus; Petitioner did not include Resident 42 on the August 2020 Monthly Surveillance Line List.  CMS Ex. 7 at 1.
• Residents 40, 25, 9, and 43 all took COVID-19 tests but were not included on the September 2020 Monthly Surveillance Line List.  Id. at 2.
• Resident 22 took a COVID-19 test but was not included on the October 2020 Monthly Surveillance Line List.  Id. at 4.

CMS Ex. 17 ¶¶ 12–14; CMS Ex. 4 at 7-8; CMS Ex. 45 at 8.

Surveyor Hatch identified seven instances where she contended Petitioner did not comply with its infection control policy by failing to include symptoms or precautions on a resident’s COVID-19 screening form that were recorded elsewhere in those residents’ records:

• Facility progress notes indicated Resident 1 had a cough which the facility did not document in the resident’s August 19, 2020 screening.  CMS Ex. 8 at 9, 18-21.
• Although the facility placed Resident 34 on precautions on May 31, 2020 after she complained of sore throat, muscle aches, and chills, it did not document the presence of these symptoms in her screenings on June 1, June 2, and June 4, 2020.  CMS Ex. 9 at 24, 56, 58, 59-63.
• The facility’s COVID-19 screening forms for Residents 32, 25, 9, 22, and 3 were either inconsistent with or did not reflect the presence of COVID-19 symptoms or placement on precautions documented in those residents’ progress notes.  CMS Ex. 11 at 4, 21-24; CMS Ex. 13 at 10, 19; CMS Ex. 14 at 3, 10-12; CMS Ex. 16 at 5, 22-24; CMS Ex. 15 at 16, 21; CMS Ex. 42.

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4. The November 25, 2020 Survey

MDH conducted a second COVID-19 Focused Control survey at Petitioner’s facility from November 24 to November 25, 2020.  CMS Ex. 20; CMS Ex. 17 ¶ 15.  Surveyor Charity Borresen, assisted by Surveyor Hatch, found Petitioner out of compliance with 42 C.F.R. § 483.80, Tag F880, at s/s level “L,” meaning Petitioner’s noncompliance posed an immediate jeopardy to its residents.  CMS Ex. 20 at 4.  The surveyor found the immediate jeopardy began on November 7, 2020 and continued until November 25, 2020.  Id.

Surveyor Borresen identified seven instances she believed demonstrated Petitioner’s substantial noncompliance with 42 C.F.R. § 483.80 by failing to implement transmission-based precautions after a resident displayed COVID-19 symptoms.  She asserted that after Residents 2, 8, 9, 14, 17, 36, and 38 displayed symptoms of COVID-19, Petitioner did not place them on transmission-based precautions until they tested positive for COVID-19, which occurred one to 12 days after they displayed symptoms.  CMS Ex. 24 at 2, 5, 10-43; CMS Ex. 25 at 2, 11, 16-29; CMS Ex. 26 at 2, 4-26; CMS Ex. 27 at 1, 5, 8-12; CMS Ex. 28 at 2, 20, 24-36.

• Resident 2 had a cough on November 18, 2020, was not placed on transmission-based precautions, then tested positive for COVID-19 on November 19, 2020.  CMS Ex. 22 at 2; CMS Ex. 29 at 120; CMS Ex. 20 at 6.
• Resident 8 had diarrhea on November 9, 2020, was not placed on precautions, then tested positive for COVID-19 on November 11, 2020.  CMS Ex. 23 at 24, 32-35.
• Resident 9 had diarrhea on November 7, 12, and 19, 2020, increased fatigue on November 18, 2020, was not placed on transmission-based precautions, then tested positive for COVID-19 on November 19, 2020.  CMS Ex. 24 at 2, 5, 10-43.
• Resident 14 had diarrhea on November 8, 2020, was not placed on transmission-based precautions, then tested positive for COVID-19 on November 13, 2020.  CMS Ex. 25 at 2, 11, 16-29.
• Resident 17 had diarrhea on November 7 and 10, 2020, was not placed on transmission-based precautions, then tested positive for COVID-19 on November 15, 2020.  CMS Ex. 26 at 2, 4-26.
• Resident 36 had diarrhea on November 16, 2020, was not placed on transmission-based precautions, then tested positive for COVID-19 on November 17, 2020.  CMS Ex. 27 at 1, 8-12.
• Resident 38 had diarrhea on November 8, 2020, was not placed on transmission-based precautions, then tested positive for COVID-19 on November 11, 2020.  CMS Ex. 28 at 2, 20, 24-36.

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5. The December 16, 2020 Survey

MDH conducted a third COVID-19 Focused Infection Control survey at Petitioner’s facility from December 15, 2020 to December 16, 2020.  CMS Ex. 32.  Surveyor Lois Boerboom determined Petitioner was not in substantial compliance with 42 C.F.R. § 483.80, Tag F880, at s/s level “E.”  Id. at 1.  The surveyor based her determination on three instances where she asserted facility staff did not immediately implement transmission-based precautions and one where they did not follow guidance on discontinuing precautions for residents with COVID-19 symptoms.  Id. at 3-7.

• On November 17, 2020, Petitioner discontinued transmission-based precautions for Resident 5 ten days after being diagnosed with COVID-19 on November 7, 2020.  CMS Ex. 34 at 10, 15.  That same day, however, Resident 5 had diarrhea, a potential symptom of COVID-19, and then again on November 21, 22, 26, 29, December 1, 4, 6, 7, 10, 11, 12, 13, and 15, 2020.  Id. at 1-4, 29-69.  Petitioner did not again place Resident 5 on transmission-based precautions until December 15, 2020.  Id.
• On three occasions involving different residents – Residents 6, 9, and 20 – the resident displayed symptoms of COVID-19, such as diarrhea or coughing, but Petitioner did not place them on transmission-based precautions until the following day.  CMS Ex. 36 at 1, 4-7; CMS Ex. 35 at 1; CMS Ex. 37 at 4, 7-18; CMS Ex. 38 ¶ 9.

B.  Petitioner is not entitled to summary judgment because the PREP Act does not preclude enforcement penalties against skilled nursing facilities during a public health crisis.

Petitioner chiefly contends the Public Readiness and Emergency Preparedness Act (PREP Act) precludes liability for the deficiencies at issue here, and therefore entitles it to summary judgment.  P. Br. at 6-16.  Petitioner explains the PREP Act, first enacted in 2005 and then amended in 2013 and 2020, authorizes the Secretary to declare a public health emergency and then identify “covered countermeasures” that, if employed by “covered persons” like Petitioner, could not be used as a basis to impose liability under state or federal law for losses caused by use of those countermeasures.  Id. at 6-7; see also 42 U.S.C. §§ 247d-6d(a)(1),(b)(1).

Petitioner points out the Secretary made such a declaration concerning the COVID-19 pandemic on March 10, 2020.5  P. Br. at 7-8 (citing P. Ex. 104); 85 Fed. Reg. 15,198

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(Mar. 17, 2020).  Relying on an advisory opinion issued by the Office of General Counsel for the Department of Health and Human Services (HHS OGC), Petitioner argues it is a “covered person” within the meaning of the PREP Act.  P. Br. at 9 (citing P. Ex. 105 at 1; P. Ex. 106).  It highlights HHS OGC’s view that the PREP Act protects the decision by a covered person not to use a covered countermeasure.  Id. (citing P. Ex. 106 at 1).  Petitioner concludes the Secretary’s declaration prevents CMS from making deficiency findings or imposing penalties where a skilled nursing facility takes countermeasures covered by the PREP Act.  Id. at 6-8.

CMS responds that neither the PREP Act nor HHS guidance support the notion that the Secretary intended to “alter the regulatory standards for deficiencies or the standards for liability in these cases.”  CMS Resp. at 6.  CMS explains the PREP Act explicitly excludes enforcement actions from its ambit.  Id., citing 42 U.S.C. § 247d-6d(c)(5)(C)(i).  CMS observes the HHS OGC advisory opinion cited by Petitioner confirms facilities could be subject to “federal enforcement action” in circumstances that could trigger the protections of the PREP Act.  Id., citing P. Ex. 106 at 3.  CMS also contests Petitioner’s claim that it engaged in “covered countermeasures,” noting the statute defines these as “a qualified pandemic or epidemic product,” or “a drug . . . biological product . . . or respiratory device . . . .”  CMS Br. at 24-25, citing 42 U.S.C. § 247d-6d(i)(1).  CMS points out the Secretary’s declaration similarly sets forth “covered countermeasures” that do not include the noncompliance at issue in this case.  Id. at 25.

CMS correctly argues the PREP Act does not preclude regulatory enforcement against skilled nursing facilities.  Contrary to Petitioner’s view, the statute specifically provides it should not be construed “to impair, delay, alter, or affect the authority, including enforcement discretion . . . of the Secretary.”  42 U.S.C. § 247d-6d(c)(5)(C)(i) (emphasis added).  Consistent with the plain language of the PREP Act, no iteration of the Secretary’s declaration suspended regulation of skilled nursing facilities during the pendency of the COVID-19 public health crisis.6  The HHS OGC guidance cited by Petitioner makes clear that the scope of PREP Act immunity pertained to liability in civil

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actions and makes no reference to the regulatory enforcement regime set forth by the Act.  In short, there is no basis to conclude Congress enacted the PREP Act to afford skilled nursing facilities like Petitioner a means to evade their obligation to substantially comply with the Act and its implementing enforcement regulations.

Even if the PREP Act could apply here, Petitioner has not established the conduct which formed the basis of the deficiency findings and the imposition of penalties at issue here amounted to “covered countermeasures.”  See P. Ex. 104 at 8 (defining “covered countermeasures” to mean “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.”).

As CMS notes, none of Petitioner’s actions here – the failure to follow its own policy for the return to work of symptomatic employees, timely implement transmission-based precautions, or consistently follow a system to surveil infection spread among residents – can by any stretch of the imagination amount to “covered countermeasures.”  CMS Br. at 24-25.  Even if they did, Petitioner’s claim that its lapses amounted to a choice not to implement countermeasures, and are thus precluded from liability, is specious.

As I discuss more thoroughly infra, Petitioner did not decline to implement countermeasures to conserve precious and limited resources during a public health crisis.  Rather, the facility fashioned an infection control policy consistent with prevailing public health guidance and simply failed to follow it.  That failure does not amount to a calculated decision by Petitioner not to apply certain countermeasures to preserve dwindling resources, as the PREP Act contemplates.  It is simply noncompliance.

C.  Petitioner was not in substantial compliance with 42 C.F.R. § 483.80 because it failed to follow its own infection prevention and control policies.

42 C.F.R. § 483.80 requires facilities to establish and maintain an infection prevention and control program that provides a safe, sanitary, and comfortable environment to prevent the development and transmission of communicable diseases and infections.  The regulation does not mandate specific standards and measures but rather grants skilled nursing facilities discretion to develop and implement infection control protocols consistent with professionally recognized standards of nursing care.  Golden Living Ctr. – Superior, DAB No. 2768 at 5 (2017).

Once a facility develops policies and protocols, it is required to implement those protocols and assure they are effective.  Id.  A facility is not in substantial compliance with participation requirements when it fails to follow standard precautions and isolation

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control procedures specified in its internal infection control policies.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13 (2014).

CMS argues Petitioner’s noncompliance with its infection control regulation is well-established by the facility’s failure to follow the CDC guidelines it incorporated into its own infection control policy concerning when staff could return to work after showing COVID-19 symptoms, the implementation of transmission-based precautions for residents who displayed COVID-19 symptoms, and the tracking of resident information and infection surveillance.  CMS Br. at 17-19; CMS Ex. 41 at 2; CMS Ex. 45 at 2.

In response, Petitioner asserts CMS ignored relevant evidence, failed to abide by regulatory requirements, and failed to establish a prima facie case of immediate jeopardy.  P. Br. at 5.  Petitioner contends CMS has not established the facility’s residents were placed at risk of infection by its failure to follow prevailing infection control standards at the time, claiming the agency’s evidence to be at best speculative.  Id.  Petitioner also claims CMS failed to consider the “evidentiary probative value and protocols issued by the one federal agency that Congress determined is the best positioned to evaluate culpability when fighting the COVID-19 pandemic,” namely the Department of Health and Human Services.  Id.

Petitioner’s claims are without merit.  As I have already explained, the Secretary did not set forth standards to “evaluate culpability” under the PREP Act that affected a skilled nursing facility’s preexisting obligations under the Act and its implementing regulations.  Petitioner cannot plausibly claim its failure to follow prevailing infection control guidelines did not place its residents at risk of harm, particularly given its decision to adopt those guidelines concerning infection control and incorporate them into its own infection control policy.

1. Petitioner did not follow its policy concerning the return to work of employees who exhibited symptoms of COVID-19.

Petitioner indicated it would “follow MDH and CDC guidelines for employees diagnosed with COVID and plan to return to work.”  CMS Ex. 45 at 2.  The CDC set forth two possible pathways for symptomatic employees to return to work; using a symptom-based approach, a facility could allow symptomatic staff to return to work if at least 10 days had passed since the first appearance of symptoms and other criteria were satisfied.  CMS Ex. 41 at 2.  A facility could also employ a test-based strategy and allow symptomatic staff to return to work without a period of absence if they produced two negative COVID-19 tests, taken more than 24 hours apart, and showed improvement in their symptoms.  Id.

Despite incorporating the CDC’s guidelines into its infection control policy, Petitioner permitted NAs 1, 2, and 4, RN 1, and LA 1 to return to work within 10 days of reporting

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COVID-19 symptoms.  CMS Ex. 4; CMS Ex. 5; CMS Ex. 6.  Petitioner did not document negative COVID-19 tests for any of these staff members, the only way permitted by facility policy for staff to return to work within 10 days of showing symptoms.  CMS Ex. 6.  By allowing its employees to return to work within 10 days of showing COVID-19 symptoms without documenting negative COVID-19 tests for them, Petitioner failed to follow its own policy.  CMS Ex. 41 at 2.  A skilled nursing facility’s failure to follow its own seasoned judgment concerning infection control amounts to persuasive evidence that it placed its residents at risk of harm and thus noncompliance.  Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13.

2. Petitioner did not follow its policy concerning the implementation of Transmission-based precautions for residents who displayed COVID-19 symptoms.

The undisputed evidence of record also establishes Petitioner failed to follow its own policy concerning the implementation of Transmission-based precautions for residents who displayed COVID-19 symptoms.  That policy required staff to mask these residents, immediately place them on droplet precautions,7 close the door to their rooms, and notify MDH, the assigned regional clinician, and the local hospital.  CMS Ex. 45 at 3.  It also required the facility to place a PPE station and appropriate signage at the door of affected residents’ rooms for a 14-day quarantine period, which could not be discontinued without COVID-19 testing and a clinical assessment two to three days before its end.  Id. at 3-4.

There is no dispute Petitioner did not follow this policy.  At the time of the surveys, the CDC identified symptoms of COVID-19 to include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.  CMS Ex. 42 at 1.  During the November 25, 2020 survey, Surveyor Borresen documented a delay of at least one day and up to 12 days for Petitioner’s staff to place Residents 2, 8, 9, 14, 17, 36, and 38 on Transmission-based precautions after they displayed COVID-19 symptoms.  CMS Ex. 24 at 2, 5, 10-43; CMS Ex. 25 at 2, 11, 16-29; CMS Ex. 26 at 2, 4-26; CMS Ex. 27 at 1, 5, 8-12; CMS Ex. 28 at 2, 20, 24-36.

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During the December 16, 2020 survey, Surveyor Boerboom discovered Petitioner delayed placing Residents 6, 9, and 20 on Transmission-based precautions for one day after they exhibited symptoms of COVID-19.  CMS Ex. 36 at 1, 4-7; CMS Ex. 35 at 1; CMS Ex. 37 at 4, 7-18; CMS Ex. 38 ¶ 9.  The surveyor also noted Petitioner improperly discontinued Transmission-based precautions for Resident 5, who exhibited ongoing symptoms of COVID-19 after discontinuation for almost a month before Petitioner reinstituted Transmission-based precautions for the resident.  CMS Ex. 34 at 1-4, 10, 15, 29-69.  These one- to 12-day delays, documented for 11 residents over two surveys, plainly contradict Petitioner’s written policy concerning the isolation of residents exhibiting symptoms of COVID-19.

Petitioner does not contest these facts but claims its staff exercised professional judgment in declining to implement enhanced precautions for these residents because diarrhea and coughing were too common to attribute to COVID-19.  P. Br. at 3.  It contends diarrhea was not a reliable indicator for COVID-19, that the CDC only suggested but did not require isolation for it, and that for purposes of tracking potential COVID-19 symptoms, the MDH defined diarrhea to mean three bouts in 24 hours.  Id. at 13-18.

Petitioner’s arguments fail because they are unsupported by the record and entirely inconsistent with the policy it chose to adopt concerning when to implement Transmission-based precautions.  There is no evidence extant from patient care notes or other records to corroborate Petitioner’s claim its staff intentionally and selectively declined to apply the facility’s infection control policy as a matter of professional judgment.  It is unlikely any health care professional would take such a risk, given the clarity of that policy.  Petitioner highlighted the requirement to isolate residents known or suspected to have COVID-19 symptoms in its COVID-19 screening tool, which instructed staff to “IMMEDIATELY ISOLATE” any resident who exhibited symptoms of COVID-19.  CMS Ex. 22 at 1 (emphasis in original); see also CMS Ex. 45 at 3 (“If you suspect a resident has COVID-19, immediately place them in droplet 
precautions . . . .”); CMS Ex. 42 at 1 (identification by the CDC in May 2020 of symptoms suggestive of COVID-19, among them coughing and diarrhea).

Petitioner’s policy did not afford its staff discretion or flexibility concerning the nature of these symptoms or the frequency of their occurrence.  It set forth a bright-line rule members of staff were expected to follow.  This lack of nuance appears intentional and entirely appropriate for a burgeoning global health crisis fueled by a novel infectious disease.  Petitioner’s present effort to defend its lax adherence to its straightforward infection control protocol is undermined by the fact that Residents 2, 8, 9, 14, 17, 36, and 38 all subsequently tested positive for COVID-19.  It would have been prudent for Petitioner to simply comply with its own policy.

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3. Petitioner did not follow its policy to track data pertaining to resident infections.

Lastly, the undisputed evidence of record establishes Petitioner failed to adhere to its own policies concerning the tracking of resident infections.  Petitioner’s policy directed its Infection Preventionist to document the testing of individual residents and staff.  CMS Ex. 45 at 7-8.  Petitioner’s policy required its staff to use an “Existing Resident COVID-19 Screening Tool” to document resident temperature and O2 saturation measurements, among other screening factors.  Id. at 2.  It also required the facility’s Infection Preventionist to collate these individual resident infection reports and summarize them by unit, site, and pathogen every month.  Id. at 10; see also CMS Ex. 7.  For residents with transmissible infections of concern like COVID-19, Petitioner’s policy required the Preventionist to collect “[t]reatment measures and precautions (interventions and steps taken that may reduce risk[)].”  CMS Ex. 45 at 10.

There is no dispute Petitioner failed to consistently and accurately record COVID-19 symptoms and precautions taken for its residents in its individual infection reports.  Screening records for Residents 1, 32, 34, 25, 9 and 22 all revealed discrepancies or omissions compared to the residents’ treatment records.  R1 exhibited a cough with blood on August 19, 2020, but the facility’s screening record for that same day indicated no cough present.  CMS Ex. 8 at 9, 18-21.  R34 complained of sore throat, muscle aches, and chilliness on May 31, 2020, but her screening records from June 1 to June 6, 2020 document none of these symptoms.  CMS Ex. 9 at 23-24, 54-70.

R32 complained of sore throat, body aches, and a headache on September 24, 2020, but despite being placed on droplet precautions pending the outcome of a COVID-19 test, facility staff indicated the absence of these symptoms on his screening record for that day.  CMS Ex. 11 at 4-5, 18.  On September 26, 2020, R25 complained of coughing, chills, body ache, and fever, but Petitioner’s staff indicated none of these symptoms were present on the corresponding screening record.  CMS Ex. 13 at 10, 19.  Petitioner placed R9 in isolation pending the results of a COVID-19 test after the resident exhibited loose stools on September 28, 2020, but while the corresponding screening record for that day records the presence of diarrhea, it indicates R9 was not in isolation.  CMS Ex. 14 at 3-4, 8.

On September 29, 2020, R43 vomited and complained of overall ache severe enough to be sent to the hospital for emergent care, but the corresponding screening record documents no symptoms.  CMS Ex. 15 at 16, 21.  On October 19, 2020, although Petitioner placed R22 on isolation precautions after he complained of upset stomach and chills and exhibited loose stools and weakness, the corresponding screening record indicated the resident was in isolation but failed to record the presence of any symptoms.  CMS Ex. 16 at 5, 23.

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There is equally no dispute Petitioner failed to document this essential information in its monthly reports.  The facility did not document the precautions it employed for residents who exhibited signs of possible COVID-19 infection in its August and September 2020 monthly reports.  CMS Ex. 7 at 1-3 (no precautions identified for R1, who exhibited coughing with blood on August 19, 2020; R24, who had been exposed to COVID-19 by family on August 21, 2020 but did not receive a COVID-19 test until August 25, 2020; or R32, who exhibited coughing and body ache on September 24, 2020).

Conversely, Petitioner documented the administration of COVID-19 tests to several residents in its monthly reports with no symptoms indicated or other reason why it administered those tests, making it impossible to track symptoms or precautions taken for those residents.  Id. at 2-4 (Residents 9, 22, 25, 40, 42, and 43 all identified as receiving COVID-19 tests with no mention of symptoms or other bases for testing).

In sum, Petitioner’s failure to accurately document critical information like the presence of symptoms, the use of transmission precautions, and the basis for administering COVID-19 tests made tracking infectious disease symptoms and accurate surveillance of the facility impossible.  It also squarely violated the facility’s own infection control policy.  I therefore find Petitioner failed to follow its own infection control policies and thus failed to substantially comply with its obligation to maintain an effective infection control program pursuant to 42 C.F.R. § 483.80(a)(1).  Golden Living Ctr. – Superior, DAB No. 2768 at 7-8; Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12-13.

D.  Petitioner’s claim of surveyor bias is irrelevant.

Petitioner asserts summary judgment is improper here because a hearing is necessary for me to assess the credibility of Surveyor Boerboom, whom it accuses of bias.  P. Br. at 20-22.  Petitioner asserts the surveyor, who was present during the December 2020 survey,  inquired whether the new owners of Petitioner’s facility “were Jewish” during a 2015 survey at the facility.  Id. at 20, citing P. Ex. 115.  Petitioner also points to “distasteful, xenophobic images” posted to Facebook by an unidentified MDH Unit Supervisor in 2019.  Id. at 20-21.

Petitioner’s assertion that these allegations preclude summary judgment is incorrect because even if true, they are not material.  Petitioner admits the MDH Unit Supervisor had no role to play in the surveys at issue here.  Id. at 21 n.15.  Its accusations concerning Surveyor Boerboom are equally irrelevant because I have not relied on her opinions, observations, or characterization of statements or actions taken by Petitioner’s staff to establish the facts underlying my findings.  Had I done so, it would perhaps be appropriate to hold a hearing where Petitioner could dispute the veracity of the surveyor’s observations or characterizations.  That is not the case here.  My factual findings are

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based entirely on documentary evidence generated by Petitioner – its own patient records, screening records, and facility policy.  Petitioner has not disputed the authenticity of the documents proffered by CMS or contradicted the factual findings made by MDH.  It has instead argued it is entitled to statutory immunity or otherwise sought to explain why it did not actually need to follow its own policy.

Because my findings here are based on Petitioner’s own documentation, its claims of bias are immaterial.  Jewish Home of E. Pa., DAB No. 2254 at 14-15 (2009), aff’d, Jewish Home of E. PA v. Ctrs. for Medicare and Medicaid Servs., 693 F.3d 359, 363 (3rd Cir. 2012) (providing allegations of surveyor bias are irrelevant “where objective evidence [such as the facilities’ own records] establishes noncompliance . . . .” because the ALJ’s de novo evaluation of that evidence would counter any bias in a surveyor’s evaluation of that evidence) (internal citations omitted).  The evidence of record establishes the noncompliance alleged by CMS.  Petitioner’s claim that it is entitled to a hearing because of alleged surveyor bias is without merit.

E.  CMS’s immediate jeopardy determination is not clearly erroneous.

Immediate jeopardy exists if a facility’s noncompliance “has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  The regulation does not require a resident to sustain actual harm or a surveyor to observe or identify a particular resident harmed or threatened with harm.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2).

The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy; the Board has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)), aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs., 174 F. App’x. 932 (6th Cir. 2006); see also, e.g., Easley v. Cromartie, 532 U.S. 234, 242 (2001) (“In applying [the clearly erroneous] standard, . . . a reviewing court must ask whether, ‘on the entire evidence,’ it is ‘left with the definite and firm conviction that a mistake has been committed.’”).

Here, CMS adopted MDH’s immediate jeopardy determination made by surveyors during the second COVID-19 focused survey from November 24 to November 25, 2020 based on deficient infection control practices at the “L” scope and severity level.  CMS Ex. 2 at 1; CMS Ex. 20; CMS Ex. 17 ¶ 15.  The surveyors found the immediate jeopardy began on November 7, 2020 and continued until November 25, 2020.  CMS Ex. 20 at 1.

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Petitioner challenges CMS’s immediate jeopardy determination as clearly erroneous, contending the agency has not shown a “causal link between the deficient practice on the one hand, and an immediate and serious risk of harm on the other.”  P. Br. at 16.

Petitioner otherwise claims its allegedly deficient practices could not have constituted immediate jeopardy to its residents because “available countermeasure were not effective to combat [COVID-19].”  P. Br. at 17, citing P. Ex. 101.8  Petitioner asserts any risk of harm to its residents was properly attributable to the pandemic and COVID-19 infection rates in the surrounding community rather than its noncompliance with the CDC’s guidelines, which it characterizes as non-binding and ineffective, given the frequency at which the CDC modified them.  Id. at 18.

Petitioner’s arguments are unavailing.  As CMS correctly observes, it does not have the burden of showing Petitioner’s noncompliance posed an immediate jeopardy; instead, Petitioner must demonstrate CMS’s immediate jeopardy finding was clearly erroneous.  CMS Resp. at 4, citing Owensboro Place & Rehab. Ctr. – Johnston, DAB No. 2397 at 10 (2011) (citations omitted).  Petitioner’s arguments to that effect are not persuasive.  Its claim that its failure to follow basic infection control procedures during a novel pandemic did not pose a risk of harm to its residents because they would have likely been infected anyway is simply callous.  Contrary to Petitioner’s view, the CDC made clear that “a strong infection and control (IPC) program is critical to protect both residents and health care personnel (HCP).”  CMS Ex. 43 at 1.  The CDC never varied from this basic principle, as Petitioner now claims.

The fact that community infection rates were high does not excuse Petitioner from observing basic infection control measures, as it contends.  Rather, the emergent circumstances of a global pandemic heightened the facility’s obligation to ensure its staff did not return to work without ensuring they were clear of infection, to follow Transmission-based precautions for residents suspected to be infected with COVID-19, and to consistently record data for individual residents and in monthly compiled reports so that it could observe trends and minimize defects in its infection control program.  
Petitioner failed to do any of these things.  It is reasonable to conclude these failures increased the risk of serious harm to its residents, who were typically elderly and infirm, by making it more likely they would contract a novel and deadly disease.

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Petitioner also claims MDH did not afford it the time to which it was entitled to correct the deficiencies the state agency cited at the November 5, 2020 survey, making the immediate jeopardy citation from the November 25, 2020 survey premature.  P. Br. at 18-20.  Petitioner contends it had until December 8, 2020 to correct the deficiencies cited in the November 5, 2020 survey, the date established in its Plan of Correction.  Id. at 18.  Petitioner is incorrect.  MDH did not conduct a revisit survey on November 25, 2020 to assess whether Petitioner corrected the deficiencies cited after the November 5, 2020 survey.  Rather, MDH conducted a separate COVID-19 Infection Control survey that involved different residents and facts.  CMS Reply at 7; CMS Ex. 20.  CMS may conduct surveys as frequently as necessary to assess a facility’s compliance with Medicare participation requirements.  42 C.F.R. § 488.308(c)(1).  It does not need to wait until the time a facility receives to execute a plan of correction from an earlier survey expires to do so.

In sum, Petitioner’s noncompliance exposed its residents to the risk of infection and therefore posed an immediate jeopardy with the potential for serious injury or harm to resident safety from November 7 to November 25, 2020.  Based on the undisputed facts in the record before me, I cannot say CMS’s determination was clearly erroneous.

F.  The CMP Imposed is Reasonable

CMS is authorized to impose reasonable enforcement remedies against a facility not in substantial compliance with participation requirements.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  Here, CMS imposed both per-instance and per-day CMPs.  In determining the reasonableness of the penalty amount imposed by CMS, I look to the factors set forth at 42 C.F.R. §§ 488.438(f) and 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)).  These factors include the seriousness of the deficiency and the facility’s compliance history, financial condition, and degree of culpability.  Id.  The CMP amount selected by CMS is presumptively reasonable based on the regulatory factors listed above and the burden is on the penalized skilled nursing facility “to demonstrate, through argument and the submission of evidence addressing the regulatory factors, that a reduction [in the penalty amount] is necessary to make the CMP amount reasonable.”  Crawford Healthcare & Rehab., DAB No. 2738 at 19 (2016).

Petitioner contends its actual level of culpability does not support the CMPs imposed by CMS because the agency has not established the facility’s deficient practices placed residents in immediate jeopardy.  P. Br. at 22.  Petitioner points out it “diligently recorded bowel elimination statistics, [] tracked coughs and other possible symptoms, and, significantly, subjected these exact same residents to repeated testing.”  Id.  Petitioner does not address the remaining factors set forth at 42 C.F.R. § 488.438(f) to argue why the CMP would otherwise be unreasonable.

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CMS observes Petitioner repeatedly violated its own infection control policies over a span of eight months and three surveys during a global pandemic and prior the availability of vaccines, making compliance with these policies one of the few tools available to prevent or reduce death or injury from the spread of COVID-19.  CMS Br. at 22.  CMS also asserts Petitioner failed to accurately track COVID-19 symptoms and implement necessary Transmission-based precautions for both residents and employees, all of which were standard infection control practices before the pandemic.  Id.  CMS contends the CMP amounts it imposed were justified by Petitioner’s frequent lapses in implementing its infection control policies that put its residents in immediate jeopardy during the COVID-19 outbreak.  Id. at 23.

I concur with CMS’s characterization of the seriousness of Petitioner’s noncompliance.  Failing to follow basic infection control protocols during a novel pandemic cannot be later justified as the professional exercise of discretion.  Nor can that failure be excused relying on Petitioner’s fatalistic view that the rate of community spread put the facility’s residents at risk of harm whether it complied or not.

I therefore find Petitioner’s culpability and the seriousness of its noncompliance to be high.  Based on my consideration of these regulatory factors, I find the imposition of a $20,000 per-instance CMP, an $11,000 per-day CMP lasting from November 7, 2020 through November 24, 2020, and a $435 per-day CMP lasting from November 25, 2020 through February 3, 2021 to be reasonable.

VIX.     Conclusion

For the foregoing reasons, I conclude Petitioner was not in substantial compliance with 42 C.F.R. § 483.80.  The CMPs imposed by CMS totaling $248,885 are reasonable.