Twinbrook Healthcare and Rehabilitation Center, DAB CR6430 (2024)

DECISION

During the coronavirus disease of 2019 (COVID or COVID-19) pandemic, Twinbrook Healthcare and Rehabilitation Center (Petitioner or the facility), a skilled nursing facility (SNF) located in Erie, Pennsylvania that participates in the Medicare program, failed to relocate two COVID-negative residents after those residents’ roommates tested positive for COVID-19.  Surveyors from the Pennsylvania Department of Health (state agency or PA DOH) concluded that Petitioner did not implement its infection control program (ICP) properly and immediately jeopardized the health and safety of the COVID-negative residents.  The Centers for Medicare & Medicaid Services (CMS) agreed with the state agency and imposed a civil money penalty (CMP) on Petitioner.  Petitioner appealed.  For the reasons stated below, I uphold CMS’s finding that Petitioner engaged in immediate jeopardy-level noncompliance and conclude that the CMP imposed is reasonable.

I.  Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post‑hospital . . . care” for individuals over the age of 65 who are eligible for Social

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Security retirement benefits and for individuals under 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

In addition to complying with the terms of the provider agreement, a participating SNF must meet a variety of ongoing statutory requirements regarding how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i‑3(a)(3), (b)-(d).  SNFs also must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”¹  42 U.S.C. § 1395i-3(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.²

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.  To maintain “substantial compliance,” an SNF’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.

Broadly, noncompliance that subjects an SNF to enforcement remedies is divided into two levels.  One level comprises deficiencies that immediately jeopardize the health or safety of residents and the other level is composed of deficiencies that do not.  42 U.S.C. § 1395i-3(h)(1).  “Immediate jeopardy” exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

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The Secretary has the duty to enforce the statutory and regulatory participation requirements for SNFs.  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to conduct surveys to determine whether SNFs are in substantial compliance.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i‑3(g)(2)(A)(i), (iii)(I).  State agencies also conduct investigations into complaints against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).  When the results of a survey show that an SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  When CMS selects an enforcement remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.³  See 42 C.F.R. § 488.404(a)-(b).

One such remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after March 17, 2022, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,400 to $23,989 for per-instance CMPs; $120 to $7,195 per day for less serious noncompliance; or $7,317 to $23,989 per day for more serious noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2022); 87 Fed. Reg. 15,100, 15,111-15,112 (Mar. 17, 2022); see also 42 C.F.R. § 488.438(a) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of substantial noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance (if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF).  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

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If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if CMS makes such a showing, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson,129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting a CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may request review of an ALJ’s decision.  42 C.F.R. § 498.80.

II.  Background and Procedural History

From July 7, 2022 through July 15, 2022, surveyors from the state agency conducted a recertification survey of Petitioner’s facility.  P. Ex. 2; CMS Ex. 2; CMS Ex. 22 ¶ 6.  Based on the survey, the state agency documented in a Statement of Deficiencies (SOD) the following noncompliance with Medicare program requirements:

• 42 C.F.R. § 483.12(a)(3), (4) (F-Tag 606) (S/S = D) (Not Employ/Engage Staff w/ Adverse Actions);
• 42 C.F.R. § 483.21(b)(1) (F-Tag 656) (S/S = D) (Develop/Implement Comprehensive Care Plan);
• 42 C.F.R. § 483.21(b)(2)(i)-(iii) (F-Tag 657) (S/S = E) (Care Plan Timing and Revision);
• 42 C.F.R. § 483.60 (i)(1), (2) (F-Tag 812) (S/S = F) (Food Procurement, Store/Prepare/Serve-Sanitary);
• 42 C.F.R. § 483.70 (F-Tag 835) (S/S = E) (Administration);       
• 42 C.F.R. §§ 483.20(f)(5), 483.70(i)(1)-(5) (F-Tag 689) (S/S = D) (Resident Records – Identifiable Information).
• 42 C.F.R. § 483.80(a)(1), (2), (4), (e), (f) (F-Tag 880) (S/S = J) (Infection Prevention and Control).

P. Ex. 2; CMS Ex. 2.  The state agency found that the deficient conduct involving 42 C.F.R. § 483.80(a)(1)-(2) immediately jeopardized the health and safety of residents

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from July 12, 2022 through July 13, 2022.  P. Ex. 2 at 19, 21-22; P. Ex. 3 at 1; CMS Ex. 2 at 33, 36, 38.

In a July 26, 2022 notice of initial determination, the state agency informed Petitioner that, as authorized by CMS, it was imposing on Petitioner a discretionary denial of payment for new admissions (DPNA) and a directed plan of correction.  P. Ex. 3 at 2 (“[T]his letter represents formal notice of imposition of these stipulated remedies.”).  The notice provided Petitioner with instructions on how to appeal.  P. Ex. 3 at 2.  The notice also stated that, should CMS impose additional enforcement remedies on Petitioner, CMS would send a separate notice.  P. Ex. 3 at 3.  CMS ultimately imposed a DPNA from August 10, 2022 through September 1, 2022.  CMS Ex. 3 at 1.

On August 5, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a notice of initial determination imposing a $10,685 per-day CMP on Petitioner for two days (July 12, 2022 and July 13, 2022) and a $245 per-day CMP commencing on July 14, 2022, and ending when Petitioner returned to substantial compliance with Medicare participation requirements.  P. Ex. 16 at 1-2; CMS Ex. 1 at 1-2.  In an October 17, 2022 notice, CMS informed Petitioner that the duration of the $245 per-day CMP was for 50 days, beginning July 14, 2022, and continuing through September 1, 2022.  CMS Ex. 25 at 1.

In August 2022, Petitioner requested Independent Informal Resolution (IIDR) related to the 42 C.F.R. § 483.80(a)(1)-(2) deficiency as well as the determination that Petitioner immediately jeopardized the health and safety of residents.  P. Exs. 1, 25-27; CMS Ex. 14.  In an August 21, 2022 letter, the IIDR reviewer recommended that the state agency overturn the 42 C.F.R. § 483.80(a)(1)-(2) deficiency finding.  P. Ex. 14; CMS Ex. 15.  In a September 9, 2022 letter, the state agency informed Petitioner that it rejected the recommendation of the IIDR reviewer and that the 42 C.F.R. § 483.80(a)(1)-(2) deficiency would remain.  P. Ex. 15; CMS Ex. 16 at 1.

In a request for hearing dated October 4, 2022, Petitioner sought a hearing to dispute the 42 C.F.R. § 483.80(a)(1)-(2) deficiency, the finding that the deficiency immediately jeopardized the health and safety of residents, and the CMP imposed.  P. Ex. 17.  On October 7, 2022, the Civil Remedies Division acknowledged Petitioner’s hearing request and issued my Standing Prehearing Order (SPO).  In compliance with the SPO, on January 5, 2023, CMS submitted a prehearing exchange consisting of a prehearing brief/motion for summary judgment and 25 proposed exhibits.  One of the exhibits was the written direct testimony for a witness (CMS Ex. 22).  On March 10, 2023, Petitioner filed its prehearing exchange consisting of a prehearing brief and opposition to summary judgment (P. Br.) and 27 proposed exhibits.  Petitioner submitted a witness list with two witnesses on it; however, Petitioner did not file written direct testimony for those witnesses.  Petitioner also requested to cross-examine CMS’s witness.  On March 15, 2023, CMS filed, unopposed, an amended prehearing brief (CMS Br.).  CMS waived its right to file a reply brief.

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III.  Issues

The issues in this case are the following: 

1. Whether Petitioner was in substantial compliance with the Medicare program requirements for SNFs at 42 C.F.R. § 483.80(a)(1)-(2).
2. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2), whether that deficiency immediately jeopardized the health and safety of residents.
3. If Petitioner was not in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2), whether a $10,685 per-day CMP for two days is reasonable under the statutory and regulatory factors for setting a penalty amount. 

CMS asserts that Petitioner did not appeal any of the non-immediate jeopardy deficiencies found during the state agency survey and the imposition of a DPNA from August 10, 2022 through September 1, 2022.  CMS Br. at 2.  CMS is correct that Petitioner did not dispute those deficiencies or the imposition of the DPNA.  P. Ex. 17 (“Please accept this letter as a formal and timely request for hearing on behalf of [Petitioner] regarding a citation of F880 [42 C.F.R. § 483.80(a)(1)-(2)] in the scope and severity of Immediate Jeopardy cited on July 15, 2022. . . . We believe the issuance of the F880 as an Immediate Jeopardy . . . to be in error and urge the decision to overturn the citation and civil money penalty be considered at a formal hearing.”); see also P. Br.  Further, Petitioner did not challenge the amount and duration of the $245 per-day CMP or the duration of the DPNA.  As a result, CMS is correct that its determination as to all of those matters is legally binding on Petitioner.  See 42 C.F.R. § 498.40(b)(1) (requiring a hearing request to identify the specific issues, and findings of fact and conclusions of law in the initial determination with which a petitioner disagrees); 42 C.F.R. § 498.20(b) (stating an initial determination is binding unless appealed or CMS revises it).

In addition, it appears that the state agency imposed a civil penalty on Petitioner, under state law, based on the survey in this case.  P. Ex. 24.  That state sanction is reviewable by state officials and is not at issue in this case.  

IV.  Summary Judgment

CMS moves for summary judgment and Petitioner opposes that motion.  I grant CMS’s motion because the undisputed material facts are sufficient to show that Petitioner was noncompliant with 42 C.F.R. § 483.80(a)(1)-(2) at the immediate jeopardy scope and severity level.  Further, Petitioner did not challenge any of the statutory and regulatory factors concerning the amount of the CMP imposed; therefore, summary judgment is appropriate for that issue as well.

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Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  Bartley Healthcare Nursing & Rehab., DAB No. 2539 at 3 (2013) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986)); Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009).

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs.,388 F.3d 168, 173 (6th Cir. 2004) (quoting Celotex, 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,475 U.S. 574, 586 n.11 (1986); see also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004).  The non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact.  Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5 (2003).  In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.”  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6 (2015), aff’d sub nom.843 F.3d 1043 (5th Cir. 2016); 1866ICPayday.com, L.L.C., DAB No. 2289 at 3 (2009) (quoting Matsushita, 475 U.S. at 587).

In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non-moving party.  Heritage House of Marshall Health & Rehab., DAB No. 3035 at 8 (2021); Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr., 388 F.3d at 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004); see also Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  W. Tex. LTC Partners, DAB No. 2652 at 6-7; cf. Guardian, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”); see Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 8 (2019), quoting Johnson v. Perez, 823 F.3d 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”).

Specifically, in relation to administrative proceedings involving Medicare, it is well-established that an ALJ is empowered to decide a case on summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 (5th Cir. 2019) (citing Cedar Lake

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Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010).  “All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”  Fal-Meridian, 604 F.3d at 449 (emphasis added).

Finally, deciding a case on summary judgment does not mean that it is decided without a hearing.  In reviewing administrative appeals decided on summary judgment, courts describe the case as having been decided without an “oral hearing” or without an “evidentiary hearing.”  They recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a hearing.  See CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).

The SOD’s basis for the 42 C.F.R. § 483.80(a)(1)-(2) deficiency is that Petitioner “failed to maintain an infection prevention and control program by failing to follow infection control guidelines from the Centers for Disease Control and Prevention (CDC) and the Pennsylvania Department of Health (PA DOH) to reduce the spread of infections and prevent cross-contamination during the COVID-19 pandemic.”  CMS Ex. 2 at 32-33.  The SOD asserted that Petitioner’s conduct immediately jeopardized two residents (i.e., R1 and R5).  CMS Ex. 2 at 33.

The SOD noted that Petitioner’s ICP did not expressly address whether COVID-negative and COVID-positive residents should remain in the same room together.  CMS Ex. 2 at 33.  The SOD then reviewed CDC and PA DOH guidance documents concerning containment of COVID-19 in SNFs and concluded that those documents prohibit COVID-positive and COVID-negative residents from sharing the same room, although COVID-negative residents who were exposed to COVID-19 may be placed in the same room together if there are space limitations.  CMS Ex. 2 at 33-35.

The SOD provided details concerning the relevant residents in this case.  On July 11, 2022, R1 and R104, who resided together in room 203, were tested and R1 was COVID-negative and R104 was COVID-positive.  Also on July 11, 2022, R5, who resided in room 202 with R67, was tested as COVID-negative.  However, on July 12, 2022, R67 tested COVID-positive.  Despite this, R1 and R5 remained in the rooms with the COVID-positive residents.  CMS Ex. 2 at 35-36.  Because this took place during the state agency survey, the surveyors informed Petitioner’s management of the immediate jeopardy situation, which was corrected by July 14, 2022.  CMS Ex. 2 at 36-38.

Petitioner does not dispute the material facts summarized in the SOD.  Chief among Petitioner’s arguments in opposition to the finding of 42 C.F.R. § 483.80(a)(1)-(2) deficiency is that, per its ICP, Petitioner properly followed current infection control guidelines from the CDC and PA DOH and that the SOD cited outdated guidelines.  P.

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Br. at 2.  Petitioner also asserts as an explanation for its actions that there had not been any open rooms for R1 and R5 in the facility.  P. Br. at 3.  In particular, Petitioner cited a PA DOH guideline for quarantine for residents who were exposed to COVID-19, which permits exposed residents to “shelter-in-place” at their current location if there are limited single rooms available or if numerous residents are simultaneously identified as having COVID-19 exposure or symptoms.  P. Br. at 4.  Petitioner also asserts that the guidelines indicate that residents who have been exposed to COVID-19, but who are up to date on the COVID-19 vaccine, do not need to be quarantined.  P. Br. at 5.

Although Petitioner disputes which provision of various CDC and PA DOH documents apply, Petitioner does not dispute that Petitioner left R1 and R5 to continue residing in rooms with their COVID-positive roommates.  P. Br. at 7.  Petitioner only provides the explanation that there were no extra rooms available, which, for summary judgment purposes, I accept.  P. Br. at 7.

Because the vaccination status of the COVID-negative residents is relevant to the guidelines that Petitioner states it applied in this matter, I note that CMS does not dispute that R5 was currently vaccinated at the time of the survey.  CMS Br. at 3.  This is consistent with Petitioner’s position that “[o]ne negative resident was up to date on vaccinations.”  P. Br. at 3.

I conclude that there are no material facts in dispute in this case and that this case may be decided on summary judgment.  The primary dispute appears to be whether CMS’s or Petitioner’s interpretation of various CDC and PA DOH COVID-19 guidelines should prevail in this case.  However, that is not an issue of fact that is in dispute, but merely which party’s reading of those guidelines is correct based on the undisputed facts in this case.  Below, I discuss in detail the undisputed facts in the case and apply the law to those undisputed facts.

V.  Evidence and Witnesses

Neither party objected to any of the proposed exhibits.  See SPO ¶ 9.  For purposes of summary judgment, I admit all of the proposed exhibits into the record.

Petitioner submitted a witness list with two proposed witnesses on it.  However, Petitioner did not submit written direct testimony for those witnesses, or otherwise request a subpoena for those witnesses to be compelled to appear at a hearing.  I exclude those proposed witnesses because Petitioner failed to comply with my SPO.

The SPO advised the parties that they “must submit as a proposed exhibit with [their] prehearing exchange the complete, written direct testimony of any proposed witness.”  SPO ¶ 10; see also Civil Remedies Division Procedures §§ 16(b), 19(b); Vandalia Park, DAB No. 1940 (2004); Pac. Regency Arvin, DAB No. 1823 at 8 (2002) (holding that the

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use of written direct testimony for witnesses is permissible.).  “Compliance with ALJ orders is not optional.”  Chit-Chat Inc., DAB No. 2936 at 9 (2019).  Failure to comply with an order or procedure is grounds sanctions, such as excluding witnesses.  See 42 U.S.C. § 1320a-7a(c)(4) (made applicable to SNF cases involving CMPs by 42 U.S.C. § 1395i-3(h)(2)(B)(ii)(I)); Civil Remedies Division Procedures § 23.

VI.  Undisputed Facts, Conclusions of Law, and Analysis

1. COVID-19 is a contagious virus that primarily spreads through respiratory droplets expelled by infected individuals when those individuals cough or sneeze.  It spreads between people when they are in close contact with each other.  COVID-19 is especially dangerous in the nursing home environment due to the congregant setting, the age of nursing home residents, and the risk to older and infirmed individuals that a respiratory infection presents.  Being over age 50 and being unvaccinated are two risk factors for a “severe” outcome to COVID-19, such as hospitalization or death.  Statistically, by 2022, approximately one third of COVID-19 deaths in the United States were nursing home residents.

According to Petitioner’s ICP:

COVID-19 is a respiratory illness thought to be spread mainly from person to person, between people who come in close contact to one another for an extended period of time.  The virus is spread through droplets produced when an infected person coughs or sneezes.  Symptoms can include fever, cough, shortness of breath, sore throat, vomiting, diarrhea, muscle pain, headache, new loss of taste or smell, chills, and repeated shaking with chills.

P. Ex. 8 at 1; CMS Ex. 6 at 1.

COVID-19 is particularly dangerous to SNF residents because, as the CDC has warned, “[o]lder adults living in congregate settings are at a high risk of being affected by respiratory and other pathogens, such as [COVID-19].”  P. Ex. 7 at 1; CMS Ex. 19 at 2. SNFs “are unique, as they serve as both healthcare providers and as full-time homes for some of the most vulnerable Americans.”  CMS Ex. 24 at 1.

The CDC stated that “[a]ge is the most important factor for severe outcomes of COVID-19” and “[s]evere outcomes of COVID-19 are defined as hospitalization, intensive care, ventilatory support, or death.”  P. Ex. 13 at 1.  Two of the three risk factors identified by the CDC for severe COVID-19 are being 50 years of age or older and “[b]eing unvaccinated or not being up to date on COVID-19 vaccinations.”  P. Ex. 13 at 1.

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In general, CDC found that “age is the strongest risk factor for severe COVID-19 outcomes. . . . ”  P. Ex. 13 at 4.  In a June 15, 2022 document, CDC stated that residents in SNFs “accounted for more than 35% of all COVID-19 deaths.”  P. Ex. 13 at 4.

2. On July 11, 2022, R1 and R104 resided in the same room at Petitioner’s facility.  On July 11, 2022, R104 tested positive for COVID-19, but R1 tested negative for COVID-19.  R1 was not vaccinated against COVID-19.  Petitioner decided that R1 should continue to reside in the same room with R104 despite the fact R104 tested positive for COVID-19.  At the same time, R5 and R67 resided together in the same room at Petitioner’s facility.  On July 11, 2022, R5 tested negative for COVID-19.  On July 12, 2022, R67 tested positive for COVID-19.  R5 was vaccinated against COVID-19.  Despite R67 testing positive, Petitioner maintained R5 in the same room with R67.  At the insistence of state agency surveyors, Petitioner moved R1 and R5 into the same room and away from their COVID-positive roommates by no later than July 14, 2022.

As stated above, the SOD provided details concerning the COVID-negative residents who surveyors found to be in rooms with COVID-positive residents.  On July 11, 2022, R1 and R104, who resided together in room 203, were tested and R1 was COVID-negative and R104 was COVID-positive.  Also on July 11, 2022, R5, who resided in room 202 with R67, was tested as COVID-negative.  However, on July 12, 2022, R67 tested COVID-positive.  Despite this, R5 remained in room 202.  Petitioner moved R1 and R5 to a room together after state agency surveyors intervened and Petitioner filed a corrective action plan late on July 12, 2022, which indicated that Petitioner would immediately move them.  CMS Ex. 2 at 35-36.  As stated earlier, Petitioner did not dispute these facts that were in the SOD.

The record corroborates most of these facts from the SOD.  On July 11, 2022, a symptomatic resident at the facility tested positive for COVID-19.  When the facility tested all the residents, a total of four residents and one staff were COVID-positive.  By July 12, 2022, there was a fifth COVID-positive resident.  Petitioner left two COVID-negative residents in the same rooms with COVID-positive residents.  P. Ex. 11.

On a resident roster dated July 12, 2022, R1 and R104 were listed as sharing room 203, and R5 and R67 were listed as sharing room 202.  P. Ex. 10; CMS Ex. 7 at 1.  However, a resident roster dated July 14, 2022, R1 and R5 are listed as sharing room 201, while R104 and R67 remained in rooms 202 and 203 as originally assigned.  CMS Ex. 7 at 2.

Annotated on the July 12, 2022 roster is the vaccination status for certain residents.  R1’s status was “unvaccinated.”  P. Ex. 10.  The parties agree that R5 was up to date with the COVID-19 vaccine.  CMS Br. at 3; P. Br. at 3.

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3. Petitioner’s ICP for the COVID-19 Pandemic, revised on June 3, 2022, requires that the facility isolate, quarantine, or cohort as able, according to recent local, state, and federal guidelines, all residents who are COVID-positive, exhibiting COVID-19 signs and symptoms, or have been exposed to COVID-19. 

The relevant version of Petitioner’s ICP for the COVID-19 pandemic for the events at issue in this case was first implemented in March 2021 and revised on June 3, 2022.  The ICP is less than one page long.  P. Ex. 8; CMS Ex. 6.

The ICP provides that, for residents who are COVID-positive, exhibiting signs and symptoms of COVID-19, or were exposed to COVID-19, Petitioner’s staff will “[i]solate, quarantine, or cohort [those residents] as able according to recent local, state, or federal guidelines.  The local Department of Health should be consulted for further guidance if needed.”  P. Ex. 8; CMS Ex. 6.

4. COVID-19 guidance documents issued by the CDC and PA DOH recommend that SNFs separate COVID-positive residents from COVID-negative residents.

Petitioner provided a variety of guidance documents from PA DOH and CDC as the basis for its decision to keep R1 and R5 in rooms with roommates who were COVID-positive.  Petitioner’s ICP cross-references “recent local, state, or federal guidelines” and, below, I evaluate the guidance documents that Petitioner submitted into the record.

As an initial matter, it is important to acknowledge what has been the standard guidance as to whether COVID-negative residents could remain in rooms with COVID-positive residents.  CMS, in its April 2, 2020 COVID-19 Long-Term Care Facility Guidance, stated unequivocally that “[l]ong term care facilities should separate patients and residents who have COVID-19 from patients and residents who do not, or have an unknown status.”  CMS Ex. 24 at 3.

CMS’s guidance is consistent with CDC’s April 30, 2020 Responding to Coronavirus (COVID-19) in Nursing Homes.  If a resident “is confirmed to have COVID-19 . . . they should be transferred to the designated COVID-19 care unit.”  CMS Ex. 23 at 4.  Further, “[r]oommates of residents with COVID-19 should be considered exposed or potentially infected and, if at all possible, should not share rooms with other residents unless they remain asymptomatic and/or have tested negative for [COVID-19] 14 days after their last exposure (e.g., date their roommate was moved to the COVID-19 care unit).  Exposed residents may be permitted to room share with other exposed residents if space is not available for them to remain in a single room.”  CMS Ex. 23 at 5.

Therefore, early federal pandemic guidance decisively recommended separating COVID-positive residents from COVID-negative roommates.

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Petitioner calls the CDC’s April 30, 2020 guidance “severely outdated,” and asserts that a CDC February 2, 2022 guidance document is the correct document to apply in this case.  Petitioner summarizes CDC guidance as saying that, while placing residents suspected of COVID-19 in single rooms is ideal, if single rooms are not available or if numerous residents are simultaneously identified to have known COVID-19 exposures or symptoms, residents should remain in their current location pending return of test results.  P. Br. at 6-7.

A review of CDC’s February 2, 2022 Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes shows that there is no reason to doubt CMS’s April 30, 2020 guidance concerning the separation of COVID-positive roommates from COVID-negative ones.  P. Ex. 7; CMS Ex. 19.  One of the “Key Points” of the February 2, 2022 guidance is that “[e]ven as nursing homes resume normal practices, they must sustain core [infection prevention and control] practices and remain vigilant for [COVID-19] infection among residents and [health care providers (HCP)] in order to prevent spread and protect residents and HCP from severe infections, hospitalizations, and death.”  P. Ex. 7 at 1.  To this end, CDC recommended that each facility should determine the location for a COVID-19 care unit and that “[t]he location of the COVID-19 care unit should ideally be physically separated from other rooms or units housing residents without confirmed [COVID-19] infection.”  CMS Ex. 19 at 5.  Further, the guidance provides that “[r]esidents who are not up to date with all recommended COVID-19 vaccine doses and who have had close contact with someone with [COVID-19] infection should be placed in quarantine after their exposure, even if viral testing is negative.”  P. Ex. 7 at 3.  For residents who are up to date with COVID-19 vaccinations who have had close contact with an individual infected with COVID-19, these individuals do not necessarily need to be quarantined unless those residents develop symptoms or test positive.  P. Ex. 7 at 3.  However, CDC also states that “[s]ymptomatic residents, regardless of vaccine status, should be restricted to their rooms. . . .”  P. Ex. 7 at 4.  It is striking that nowhere in the February 2, 2022 CDC guidance does it say that COVID-positive residents should remain housed with COVID-negative residents, and the guidance clearly states that the dedicated COVID-19 care unit be separate from residents who have not tested COVID-positive.

Petitioner also relies on the PA DOH February 8, 2022 Interim Infection Prevention and Control Recommendations for Healthcare settings during the COVID-19 Pandemic.  P. Ex. 6.  However, it states:  “quarantined patients and those with suspected infection should NOT be cohorted with confirmed [COVID-19] infection unless they are confirmed to have [COVID-19] infection through testing.”  P. Ex. 6 at 7.  In line with CDC’s February 2, 2022 guidance, asymptomatic patients who are up to date with COVID-19 vaccinations do not need to be quarantined following close contact with a COVID-positive person.  P. Ex. 6 at 7.  Ideally, patients with confirmed or suspected COVID-19 infection should be placed in single rooms, although facilities could also dedicate a unit for COVID-positive patients.  P. Ex. 6 at 8.  Therefore, this PA DOH

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guidance document does not support Petitioner’s actions concerning R1 and R5 in this case and is consistent with CDC guidance, which indicates COVID-positive individuals should be separated from COVID-negative individuals.

Petitioner further relies on the PA DOH February 15, 2022 Response to an Outbreak and Residents with Exposure to COVID-19 for Long-term Care Facilities.  P. Ex. 5.  Although Petitioner believes that this guidance provides support for continuing to house COVID-positive and COVID-negative residents in the same room, it does not.  In the section on “Residents or HCP with Signs and Symptoms of COVID-19,” the guidance commands:  “Do not place a person with suspected COVID-19 into a COVID care unit prior to confirmation of infection by positive test result.”  P. Ex. 5 at 5.  This provision means that, even if a resident is suspected of having COVID-19, that resident cannot be placed in a room with a COVID-positive resident.  This provision is consistent with the preceding guidance documents discussed already, which uniformly do not permit the mixing of COVID-positive and COVID-negative residents.

However, Petitioner, ignoring this provision, quotes from a different section of the guidance on “Managing Residents with Exposure” to say that if there are no single-person rooms for an exposed resident “or if numerous residents are simultaneously identified to have known [COVID-19] exposure or symptoms concerning for COVID-19, residents should shelter-in-place at their current location while being monitored for evidence of [COVID-19] infection.”  P. Ex. 5 at 6; P. Br. at 4.  It is important to note that the quoted text makes no mention of the exposed resident sharing a room with a COVID-positive resident.  It is too much to assume that a guidance document that commands, in no uncertain terms, that only COVID-positive residents may be sent to a COVID unit, would then, silently, allow a COVID-negative resident to remain in a room with a COVID-positive resident.  Petitioner’s interpretation of this provision is unwarranted.

5. Petitioner was not in substantial compliance with infection control regulations at 42 C.F.R. § 483.80(a)(1)-(2) (F-Tag 880) because facility staff failed to implement Petitioner’s ICP.  The ICP required the facility to isolate, quarantine, or cohort as able, according to recent local, state, and federal guidelines, residents who are COVID-positive, suspected of having COVID-19, or were exposed to COVID-19.  Recent and long-standing CDC and PA DOH guidance require COVID-positive residents to be separated from residents who are not COVID-positive.  However, despite positive COVID-19 tests for R1’s and R5’s roommates, Petitioner continued to room R1 and R5 with their COVID-positive roommates.  This subjected R1 and R5 to the potential for more than minimal harm.

The Social Security Act states that an SNF must:

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Establish 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); see also 42 C.F.R. § 483.80.  The Secretary’s regulations require facilities to establish and maintain an infection control program that includes, among other things, 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.”  42 C.F.R. § 483.80(a)(1).

The statutory and regulatory injunction to “establish and maintain” an ICP requires SNFs to not only adopt an appropriate ICP, but also to implement the program’s prescribed precautions.⁴  Golden Living Ctr. - Superior, DAB No. 2768 at 7 (2017) (citing Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014)).

In this case, the undisputed facts have been stated above, which include Petitioner’s decision to continue to room R1 and R5 with residents who tested COVID-positive.  Petitioner did this despite the fact that its ICP required Petitioner to follow recent state  and federal guidance that uniformly prohibited placing COVID-positive and COVID-negative residents together.  As explained above, I reject Petitioner’s interpretation of the PA DOH February 15, 2022 guidance document that COVID-negative residents may “shelter in place” with positive residents.

Petitioner seems to justify its actions by asserting there were no rooms at Petitioner’s facility to accommodate R1 and R5.  P. Br. at 7.  Petitioner takes the position that it was riskier to move R1 and R5 because they had been exposed and could now spread COVID-19.  P. Br. at 10.  Petitioner complains that, because the state agency surveyors required moving R1 and R5, Petitioner was forced to move an immunocompromised resident passed “red rooms” to a room that had another immunocompromised resident.  P. Br. at 10-11.  As a result, Petitioner accuses the state agency surveyors of placing residents in jeopardy by forcing high risk patients to move in together.  P. Br. at 12-13.  Petitioner also states that it contacted the local health department, which agreed with

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Petitioner’s decision to leave R1 and R5 in rooms with COVID-positive roommates.  P. Br. at 8; P. Ex. 11.

Despite these various arguments, Petitioner is unable to show that it complied with its ICP.  Petitioner was required to follow recent federal, state, and local guidance, all of which makes clear that COVID-positive and COVID-negative residents should not be housed together.  Petitioner was responsible for taking appropriate action under the guidance documents to properly deal with the outbreak of five COVID-positive residents at the facility.  Instead of taking action to cohort the COVID-positive residents, Petitioner chose to do nothing.  Given that R1 and R5 were in rooms 203 and 202 respectively (P. Ex. 10), and those rooms were in close proximity to each other (P. Ex. 9), Petitioner does not explain why, given the scarcity of rooms,  it could not have designated one of those rooms (202 or 203) to cohort R1 and R5 in as exposed by COVID-negative residents and use the other to serve as the COVID-positive room for R67 and R104.  While there is no doubt that, had several single rooms been available, housing each resident separately would have been preferred.  However, even such an ad hoc arrangement as moving R1 and R5 together and R67 and R104 together would have been significantly more consistent with CDC and PA DOH guidance than leaving COVID-negative residents in rooms with COVID-positive residents.  The guidance documents all acknowledge that cohorting is an option when single rooms are not available.

Finally, the fact that Petitioner disclosed its decision to leave R1 and R5 with their COVID-positive roommates to the local health department, and the local official who answered the phone call appeared to agree with that action, does not show Petitioner to be in substantial compliance with 42 C.F.R. § 483.80(a)(1)-(2).  Petitioner’s ICP must meet national standards and Petitioner needed to follow the guidance documents providing those standards.  The record of the phone call neither shows that the local health official directed Petitioner to leave R1 or R5 in rooms with COVID-positive residents nor does it indicate that Petitioner requested the health official’s opinion on the subject.  Petitioner took its action and informed the local health department.  The local official’s apparent concurrence with that action does not absolve Petitioner of its failure to follow clear guidance provided by CDC and PA DOH.

Given the highly infectious nature of COVID-19 and the high rate at which SNF residents have died from it, there is no doubt that Petitioner’s decision to leave R1 and R5 in rooms with COVID-positive roommates placed them at risk for more than minimal harm.

6. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.80(a)(1)-(2) posed immediate jeopardy to resident health and safety 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

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regulation does not require that a resident actually be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).

I must uphold CMS’s determination as to the level of a facility’s noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and determinations of immediate jeopardy have been sustained where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  In reviewing CMS’s finding, I “must consider whether the totality of the allegations support the Agency’s determination that [the SNF’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’”  Rosewood Care Ctr., 868 F.3d at 618 (7th Cir. 2017) (emphasis omitted).

Petitioner argues that the immediate jeopardy finding should be reversed.  Petitioner asserts that it acted properly and that “the fact that no resident had an adverse effect and facility had prophylaxis, treatment, and medications readily available if needed further supports the request for the Immediate Jeopardy to be removed.  P. Br. at 11.

The state surveyors believed that the immediate jeopardy determination was warranted because “2 COVID negative residents at risk of contracting COVID while cohabitating with COVID positive roommate” and “Potential spread of COVID due to continued exposure from COVID positive and COVID negative cohabitation at present time for 2 residents.”  P. Ex. 4.

For the reasons stated below, I conclude that the evidence of record does not show it was clearly erroneous for CMS to conclude that Petitioner’s noncompliance was likely to cause serious injury, harm, impairment, or death to a resident.  The primary potential harm in this matter involved the continued exposure of R1 and R5 to COVID-positive residents.  Knowingly exposing residents to COVID-19 in this manner is extremely serious.

Both CDC’s February 2, 2022 Interim Infection Prevention and Control Recommendations to Prevent [COVID-19] Spread in Nursing Homes and the PA DOH’s February 15, 2022 updated Response to an Outbreak and Residents with Exposure to COVID-19 for Long-term Care Facilities warn facilities that they must remain vigilant for COVID-19 infection among residents and HCP in order to protect residents and HCP “from severe infections, hospitalizations, and death.”  P. Ex. 5 at 2; P. Ex. 7 at 1; CMS Ex. 18 at 2; CMS Ex. 19 at 2.  This is because “[o]lder adults living in congregate settings are at a high risk of being affected by respiratory and other pathogens, such as [COVID-19].”  P. Ex. 7 at 1; CMS Ex. 19 at 2.

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As discussed earlier in this decision, the CDC has stated that “[a]ge is the most important factor for severe outcomes of COVID-19” and “[s]evere outcomes of COVID-19 are defined as hospitalization, intensive care, ventilatory support, or death.”  P. Ex. 13 at 1.  Two of the three risk factors identified by the CDC for severe COVID-19 are being age 50 or older and “[b]eing unvaccinated or not being up to date on COVID-19 vaccinations.”  P. Ex. 13 at 1.  The CDC has recognized that “age is the strongest risk factor for severe COVID-19 outcomes. . . .”  P. Ex. 13 at 4.  In a June 15, 2022 document, CDC stated that residents in SNFs “accounted for more than 35% of all COVID-19 deaths.”  P. Ex. 13 at 4.

In the present case, R1 had two risk factors for severe outcomes if R1 contracted COVID-19 (i.e., R1 was over 50 years of age and was unvaccinated).  P. Ex. 10 at 1; P. Ex. 12 at 10.  R1’s particular risk for a severe outcome fully justified the immediate jeopardy finding.  Further, while R5 was vaccinated, continuing to house R5 with a COVID-positive resident also supports the immediate jeopardy.

7. The $10,685 per-day CMP, imposed on Petitioner for two days of immediate jeopardy-level noncompliance, is reasonable and appropriate because Petitioner did not dispute any of the relevant statutory or regulatory factors for setting the amount of a CMP.

When determining whether the amount of a CMP is appropriate, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(e)(3).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at sections 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).

Unless a facility contends that a particular regulatory factor does not support that CMP amount, the ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).  Thus, the burden is not on CMS to explain its decision-making process or to explain the relative

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weights assigned to each deficiency to support the CMP amounts imposed.  Once the facility contends that a regulatory factor does not support the CMP amount, CMS must then produce evidence as to that factor.  Coquina Ctr., DAB No. 1860 at 32.

Here, Petitioner did not dispute any of the factors, other than to dispute the finding of immediate jeopardy in this case.  As a result, I do not need to discuss the individual factors to uphold the CMP imposed.

However, for completeness, I note the following undisputed matters from record related to the statutory and regulatory factors:

• The per-day CMP amount is in the lower end of the permissible range for immediate jeopardy-level noncompliance;
• Petitioner has a significant recent history of being assessed (and paying) CMPs for noncompliance with Medicare requirements:
  • $655 for an F-level deficiency on May 3, 2021 (CMS Ex. 3 at 4);
  • $982.61 for an F-level deficiency on May 10, 2021 (CMS Ex. 3 at 3);
  • $1,300 for an F-level deficiency on July 12, 2021 (CMS Ex. 3 at 3);
  • $1,625 for an F-level deficiency on July 19, 2021 (CMS Ex. 3 at 2);
  • $3,250 for ten D-level deficiencies on September 17, 2021 (CMS Ex. 3 at 2);
  • $1,950 for an F-level deficiency on December 27, 2021 (CMS Ex. 3 at 1); and
  • $2,302.30 for an F-level deficiency on February 7, 2022 (CMS Ex. 3 at 1);
• There is no evidence that Petitioner is unable to pay the CMP imposed in this case;
• The noncompliance was at the immediate jeopardy scope and severity level; and
• Petitioner was culpable because it disregarded the clear recommendations from CDC and PA DOH when it left R1 and R5 in rooms with COVID-positive residents.

Therefore, the CMP imposed in this matter is reasonable and I uphold it. 

VII.  Conclusion

I conclude Petitioner was noncompliant with 42 C.F.R. § 483.80(a)(1)-(2) and that Petitioner’s noncompliance immediately jeopardized the health and safety of residents.  I uphold the $10,685 per-day CMP for two days as reasonable.

Endnotes

¹  “It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”  42 U.S.C. § 1395i-3(f)(1).

² All citations to the Code of Federal Regulations are to the version in effect at the time of the survey unless otherwise indicated.

³ State agencies designate the scope and severity level using a matrix published in the State Operations Manual, chap. 7, § 7400.3.1 (Nov. 16, 2018).  Scope and severity levels of A, B, or C are deficiencies for which CMS cannot impose enforcement remedies.  Scope and severity levels of D, E, or F are deficiencies that present no actual harm, but have the potential for more than minimal harm that do not amount to immediate jeopardy.  Scope and severity levels of G, H, or I indicate deficiencies that involve actual harm to a resident or residents that are not immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.

⁴ The Secretary revised the Part 483 regulations concerning SNF conditions of participation in 2016.  Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017) (technical corrections).  The infection prevention and control regulation currently promulgated in 42 C.F.R. § 483.80 was formerly found in 42 C.F.R. § 483.65.  In assessing compliance under § 483.80 in this case, I consider case decisions analyzing the former § 483.65.