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# Generations at Rock Island, DAB CR6200 (2022)

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

## Generations at Rock Island,(CCN: 14-5950)Petitioner,v.Centers for Medicare & Medicaid Services

### Docket No. C-21-676Decision No. CR6200December 13, 2022

## DECISION

Petitioner, Generations at Rock Island, is a long-term care facility located in Rock Island, Illinois, that participates in the Medicare program.  Over a period of four months, it underwent multiple surveys – including complaint investigations, partial extended surveys, a Life Safety Code survey, and a recertification survey.  Based on the survey findings, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with the Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  Among other remedies, CMS imposed civil money penalties (CMPs) of $10,180 per day for the 15 days that the facility’s deficiencies posed immediate jeopardy and $540 per day for the 107 days of substantial noncompliance that did not pose immediate jeopardy.  CMS subsequently reduced the penalties by 50%, based on Petitioner’s claims of financial hardship. 

Petitioner filed three separate appeals, which I have consolidated. 

For the reasons set forth below, I find that, from August 27 through December 27, 2020, the facility was not in substantial compliance with Medicare program requirements; that,

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from August 27 through September 10, 2020, its deficiencies posed immediate jeopardy to resident health and safety; and that the penalties imposed are not unreasonably high.1 

### Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301. 

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

**September 16, 2020 complaint investigation/partial extended survey**.  On September 16, 2020, surveyors from the Illinois Department of Public Health (state agency) completed a complaint investigation and partial extended survey of the facility.  The surveyors found that the facility was not in substantial compliance with multiple Medicare participation requirements and that some of its deficiencies posed immediate jeopardy to resident health and safety.  Specifically:  
                            - 42 C.F.R. § 483.10(a) (Tag F550 – resident rights) cited at scope and severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
                            - 42 C.F.R. § 483.10(e) (Tag F558 – reasonable accommodation of resident needs and preferences) cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);

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                            - 42 C.F.R. § 483.12(a) (Tag F600 – freedom from abuse, neglect, and exploitation) cited at scope and severity level K (pattern of substantial noncompliance that poses immediate jeopardy to resident health and safety) ; 2
                            - 42 C.F.R. § 483.12(c) (Tag F610 – freedom from abuse and neglect:  reporting and investigation) cited at scope and severity level D ;
                            - 42 C.F.R. § 483.21(b)(2) (Tag F657 – comprehensive care plans) cited at scope and severity level E;
                            - 42 C.F.R. § 483.21(b)(3) (Tag F659 – comprehensive care plans:  services provided) cited at scope and severity level D;
                            - 42 C.F.R. § 483.24 (Tag F677 – quality of life:  activities of daily living) cited at scope and severity level E;
                            - 42 C.F.R. § 483.25 (Tag F684 – quality of care) cited at scope and severity level K ;
                            - 42 C.F.R. § 483.25(d) (Tag F689 – quality of care:  accident prevention) cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety) ;
                            - 42 C.F.R. § 483.25(g) (Tag F693 – quality of care:  assisted nutrition and hydration) cited at scope and severity level D;
                            - 42 C.F.R. § 483.35 (Tag F725 – nursing services:  sufficient staffing) cited at scope and severity level G; 
                            - 42 C.F.R. § 483.45(a)(b) (Tag F755 – pharmacy services:  procedures) cited at scope and severity level D;
                            - 42 C.F.R. § 483.45(f) (Tag F760 – pharmacy services:  medication errors) cited at scope and severity level D;

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                            - 42 C.F.R. § 483.60(e) (Tag F808 – food and nutrition services:  therapeutic diets) cited at scope and severity level D;
                            - 42 C.F.R. § 483.70 (Tag F835 – administration) cited at scope and severity level E;
                            - 42 C.F.R. § 483.20(f) and 483.70(i) (Tag F842 – medical records) cited at scope and severity level E;
                            - 42 C.F.R. § 483.80 (Tag F880 – infection control and prevention) cited at scope and severity level D ;
                            - 42 C.F.R. § 483.90(d) (Tag F908 – physical environment:  space and equipment) cited at scope and severity level D; and
                            - 42 C.F.R. § 483.90(g) (Tag F919 – physical environment:  resident call system) cited at scope and severity level D. 

CMS Ex. 12.3 

CMS determined that the immediate jeopardy was abated as of September 11, 2020, but the facility continued to be substantially noncompliant.  CMS Ex. 1 at 1; CMS Ex. 6. 

**The first appeal**.  In a letter dated September 30, 2020, the state agency, on behalf of CMS, advised the facility that, based on the September 16 survey findings, it was not in substantial compliance with Medicare requirements; that its deficiencies posed immediate jeopardy to resident health and safety; that the immediate jeopardy was abated, effective September 11, 2020; and that CMS would impose remedies.  CMS Ex. 6. 

In a letter dated November 25, 2020, Petitioner appealed, broadly challenging all of the cited deficiencies, all of the determinations that were based on the deficiency findings, and all of the remedies imposed.  The Civil Remedies Division docketed the appeal as **C-21-198**.  

**October 1, 2020 complaint investigation**.  On October 1, 2020, the state agency completed another complaint investigation survey.  The surveyors found that the facility was not in substantial compliance with the following program requirements: 

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                            - 42 C.F.R. § 483.10(j) (Tag F585 – resident rights:  grievances) cited at scope and severity level D; and
                            - 42 C.F.R. § 483.25(d) (Tag F689 – quality of care:  accident prevention) cited at scope and severity level D (repeat deficiency) . 

CMS Ex. 13.  

**October 22, 2020 Life Safety Code (LSC) survey**.  The facility must meet the applicable provisions of the Life Safety Code of the National Fire Protections Association (NFPA).  42 C.F.R. § 483.90(a).  On October 22, 2020, the state agency completed a Life Safety Code (LSC) survey of the facility and determined that it was not in substantial compliance with the following LSC requirements: 
                            - K311 (LSC §§ 8.6; 19.3.1 through 19.3.1.6 – vertical openings: fire resistant barriers) cited at scope and severity level E;
                            - K321 (LSC §§ 19.3.2.1; 19.3.5.9 – hazardous areas:  fire barriers) cited at scope
                            - and severity level E;
                            - K324 (LSC §§ 18.3.2.5.2; 19.3.2.5.2 – cooking facilities:  ventilation control and fire protection) cited at scope and severity level E;
                            - K347 (LSC §§ 19.3.6.1; 19.3.4.5.2 – smoke detection systems) cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm with the potential for more than minimal harm);
                            - K353 (LSC §§ 9.7.5; 9.7.7; 9.7.8; and NFPA § 25 – sprinkler system:  maintenance and testing) cited at scope and severity level F;
                            - K363 (LSC § 19.3.6.3 – doors:  fire protection) cited at scope and severity level F;
                            - K712 (LSC §§ 19.7.1.4 through 19.7.1.7 – fire drills) cited at scope and severity level F;
                            - K741 (LSC §§ 18.7.4; 19.7.4 – smoking regulations) cited at scope and severity level F; and
                            - K920 (LSC §§ 10.2.3.6; 10.2.4 – electrical equipment:  power cords and extension cords) cited at scope and severity level E. 

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CMS Ex. 14. 

**October 29, 2020 annual recertification survey/revisit survey/complaint investigation**.  On October 29, 2020, the state agency concluded the facility’s annual recertification survey, combined with a revisit survey, and two additional complaint investigations.  The surveyors determined that the facility had not achieved substantial compliance.  Specifically, it was not in substantial compliance with the following program requirements: 
                            - 42 C.F.R. § 483.20(g) (Tag F641 – resident assessments:  accuracy) cited at scope and severity level D;
                            - 42 C.F.R. § 483.21(b) (Tag F656 – comprehensive, person-centered care planning:  baseline care plans) cited at scope and severity level D;
                            - 42 C.F.R. § 483.21(b)(2) (Tag F657 – comprehensive care plans) cited at scope and severity level D;
                            - 42 C.F.R. § 483.25(b) (Tag F686 – quality of care:  skin integrity) cited at scope and severity level D;
                            - 42 C.F.R. § 483.25(d)  (Tag F689 – quality of care:  accident prevention) cited at scope and severity level D (repeat deficiency) ;
                            - 42 C.F.R. § 483.25(g)(1)-(3) (Tag F692 – quality of care:  assisted nutrition and hydration) cited at scope and severity level D;
                            - 42 C.F.R. § 483.25(n) (Tag F700 – quality of care:  bed rails) cited at scope and severity level D;
                            - 42 C.F.R. § 483.35 (Tag F725 – nursing services:  sufficient staffing) cited at scope and severity level E (repeat deficiency) ;
                            - 42 C.F.R. § 483.45(c) (Tag F756 – pharmacy services:  drug regimen review) cited at scope and severity level D;
                            - 42 C.F.R. § 483.60(d) (Tag F804 – food and nutrition services:  food and drink) cited at scope and severity level F;
                            - 42 C.F.R. § 483.75(g) (Tag F868 – quality assessment and assurance) cited at scope and severity level F;

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                            - 42 C.F.R. § 483.80 (Tag F880 – infection control and prevention) cited at scope and severity level F (repeat deficiency) ; and
                            - 42 C.F.R. § 483.90(i) (Tag F921 – physical environment:  other environmental conditions) cited at scope and severity level D. 

CMS Ex. 15, 16, 17.4 

**The second appeal**.  In a letter dated November 18, 2020, the state agency advised Petitioner that the October 29 revisit and annual recertification survey identified additional deficiencies.  The letter noted that, because infection control deficiencies were again cited, revised remedies would be imposed.  Petitioner again requested a hearing, challenging all of the cited deficiencies, all of the determinations that were based on the deficiency findings, and all of the remedies imposed.  The Civil Remedies Division docketed its appeal as **C-21-388**. 

**December 9, 2020 revisit survey/complaint investigation**.  Surveyors returned to the facility and, on December 9, 2020, completed a revisit survey and complaint investigation.  The surveyors cited additional deficiencies: 
                            - 42 C.F.R. § 483.12(c) (Tag F609 – freedom from abuse, neglect, and exploitation:  reporting allegations of abuse and neglect) cited at scope and severity level F (repeat deficiency) ;
                            - 42 C.F.R. § 483.45(a)(b) (Tag F755 – pharmacy services:  procedures) cited at scope and severity level E ( repeat deficiency );
                            - 42 C.F.R. § 483.45(f) (Tag F760 – pharmacy services:  significant medication errors) cited at scope and severity level D. 

CMS Ex. 18. 

Following surveys completed on January 22 and January 25, 2021, CMS determined that the facility returned to substantial compliance on January 15, 2021.  CMS Ex. 1 at 2.  

**The third appeal and consolidation**.  In notices dated February 17 and February 24, 2021, CMS advised the facility that it was imposing remedies based on the complaint, LSC, and health surveys conducted on September 16, October 1, October 22, October 29, December 9, 2020, and January 14, 2021.  CMS Exs. 1, 2.  CMS subsequently

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determined that the facility **returned to substantial compliance on December 28, 2020**.  CMS Ex. 2 at 2. 

Among other remedies, CMS imposed civil money penalties (CMPs) of **$10,180 per day for 15 days of immediate jeopardy** to resident health and safety (August 27 through September 10, 2020); and **$540 per day for 107 days of substantial noncompliance** that did not pose immediate jeopardy (September 11 through December 27, 2020), for a total penalty of $210,480 ($152,700 + $57,780 = $210,480).  CMS Ex. 2 at 1-2.  CMS subsequently **reduced the total amount of the penalty by half**, to $105,240, based on the facility’s claims of financial hardship.  CMS Ex. 3 at 1; *see* 42 C.F.R. 488.438(f)(2).5

In a letter dated April 16, 2021, Petitioner appealed, again challenging all of the deficiencies cited for all of the surveys, all of the determinations that were based on the deficiency findings, and all of the remedies imposed.  The Civil Remedies Division docketed this appeal as **C-21-676**.  

In a joint motion, filed May 24, 2021, the parties asked me to consolidate the three appeals (C-21-198; C-21-388; and C-21-676).  On June 1, 2021, I granted the motion.  The cases are consolidated as **C-21-676**. 

**The parties’ submissions**.  CMS has filed a pre-hearing brief (CMS Br.) with 136 exhibits (CMS Exs. 1-136).  Petitioner filed its own prehearing brief (P. Br.) with nine exhibits (P. Exs. 1-9).  Petitioner also filed objections to some of CMS’s exhibits (P. Objections).  CMS filed a rebuttal to Petitioner’s pre-hearing submission and a motion for summary disposition (CMS Rebuttal).  Petitioner filed a reply to CMS’s Rebuttal (P. Reply). 

**Petitioner’ objections to CMS’s exhibits**.  I am required to “inquire fully into all of the matters at issue” and to admit any documents that are relevant and material.  42 C.F.R. § 498.60(b)(1).  I have broad discretion to admit evidence, and I am not bound by the federal rules of evidence.  42 C.F.R. § 498.61.  I may admit hearsay “consistent with procedural ‘integrity and fundamental fairness.’”  *Omni Manor Nursing Home,* DAB No. 1920 (2004) (quoting *Richardson v. Perales,* 402 U.S. 389, 410 (1971)). 

Petitioner objects to my admitting 13 of CMS’s exhibits: 

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                            - CMS Ex. 5 – CMS’s AEM (Automated Survey Processing Environment (ASPEN) Enforcement Manager) form.  The document sets forth the facility’s compliance history between October 2017 and February 2021.  Petitioner concedes that a facility’s history may justify CMS’s increasing a CMP but complains that the document includes allegations of noncompliance for which a hearing was not granted or for which the hearing is pending.  P. Objections at 1.

As I discuss below, the facility’s history is one of the factors I must consider in determining whether the CMP is reasonable.  42 C.F.R. § 488.438(f)(1).  The record of the facility’s history is thus obviously relevant.  Petitioner is free to attack the validity of some of the allegations set forth in the document, but that does not make the document inadmissible.  I therefore overrule Petitioner’s objection and will admit CMS Ex. 5.
                            - CMS Exs. 8-11 – Decisions made by the state agency following Informal Dispute Resolution (IDR) proceedings.  Petitioner initially argued that the documents are irrelevant because I may not rely on an IDR determination but must consider the facts presented here “with fresh eyes.”  P. Objections at 1.  After CMS pointed out that Petitioner had, in its pre-hearing brief, cited three of the IDR decisions, Petitioner agreed that the documents could be admitted because they address the scope of this matter, but they should not be used to support the underlying allegations of substantial noncompliance.  CMS Rebuttal at 4; P. Reply at 3. 

I agree that I am not reviewing the IDR conclusions or CMS’s determinations to accept or reject any of the IDR findings.  Rather, I review the facts before me on the record to determine, *de novo*, whether the facility was in substantial compliance.  *Britthaven of Chapel Hill,* DAB No. 2284 at 5-6.  Nevertheless, as Petitioner concedes, the documents are not wholly irrelevant.  Because CMS accepted several of the IDR conclusions, and those deficiencies are no longer part of this case, the IDR results offer relevant background information as to the scope of the matter before me.  I therefore admit CMS Exs. 8-11
                            - CMS Exs. 12 through 18 – CMS’s statements of deficiencies (Form CMS-2567) for the surveys completed on September 16, October 1, October 22, October 29, and December 9, 2020.  Petitioner argues that the statements of deficiencies should be excluded in their entirety because they are hearsay and because they were created with this litigation in mind.  P. Objections at 1-3; P. Reply at 2-3. 

I overrule Petitioner’s objections.  The statements of deficiencies must be admitted.  They set out the survey findings on which CMS bases the enforcement action that is the subject of this appeal and, for that reason, are “unquestionably relevant and material evidence.”  *Avalon Place Trinity,* DAB No. 2819 at 38 (2017); *see* 42 C.F.R. § 498.60(b)(1); *Guardian Health Care Ctr.,* DAB No. 1943

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at 12 (2004) (indicating that the statement of deficiencies is a “contemporaneous record of the survey agency’s observations and investigative findings.”).

I reject Petitioner’s wholly unsupported claim that the statements of deficiencies were created with this litigation in mind.  P. Reply at 2-3.  In fact, a statement of deficiencies must be generated whenever surveyors find that a facility is not in substantial compliance with any program requirement, and relatively few of those surveyor findings are appealed.  The document’s primary purpose is to advise the facility of its deficiencies so that they can be corrected.  *See* SOM Appendix P – Part III (“[W]rite the statement of deficiencies in terms specific enough to allow a reasonably knowledgeable person to understand . . . the requirement(s) that is (are) not met.”).  Moreover, Petitioner’s claim is undermined by its objection to CMS’s AEM form.  There, Petitioner acknowledges that, for many of the facility’s deficiencies cited over the years, CMS required that the facility correct them, but it imposed no penalties; hence, no litigation resulted.  

For the same reason I reject Petitioner’s gratuitous and wholly unsupported assertion that statements of deficiencies “are always disciplinary in nature and written with the express purpose of recording the impression of surveyors who are in a building for the purpose of finding and writing citations.”  According to Petitioner, the documents lack “hallmarks of truthfulness” because the surveyors are “governed by their own biases.”  Petitioner’s Reply to CMS’s Rebuttal at 2-3. This is also nonsense.  As explained above, surveyors are “in the building” because the Act and regulations require them to determine whether the facility meets statutory and regulatory requirements.  Surveyors are obligated to document, on the statement of deficiencies, the deficiencies they find.  Based on those findings, CMS determines whether penalties should be imposed.  Act § 1864(a); 42 C.F.R. § 488.20.6 

I will therefore admit CMS Exs. 12-18. 
                            - CMS Ex. 66 – A receipt showing that the facility ordered “Barri slings” on August 12, 2020, and received them on August 17.  Petitioner claims that the document is irrelevant.  Petitioner also suggests that the facility purchased the items as a remedial measure and “public policy bars the admission of remedial measures as proof certain that something was wrong.”  P. Objections at 3.

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CMS alleges that the facility did not have adequate assistance devices so that staff could safely transfer residents who needed that level of assistance, citing one resident who had needed to be transported to a dialysis appointment, and another who could not be moved off the floor because of inadequate equipment.  *See* 42 C.F.R. § 483.25(d).  The receipts are relevant because they provide some evidence as to the types of devices that could appropriately transfer these residents. 

Petitioner’s claim that the purchases were “remedial” is puzzling.  As noted above, the survey was not completed until September 16, and the notice letter was issued on September 30, 2020.  At the time these slings were purchased, no deficiencies had been cited.  Moreover, they were not ordered for any resident who is the subject of a cited deficiency.  CMS Ex. 66 at 4; *see* CMS Ex. 19 at 1.  

As the discussion below shows, these slings are designed to transfer a morbidly obese resident safely and should have been readily available for the residents who needed them.  Far from being a “remedial measure,” ordering the slings should have been a standard practice.  In any event, even under the federal rules, subsequent remedial measures are admissible for some purposes, including to show the feasibility of precautionary measures.  Fed. R. Evid. Rule 407.  I will admit CMS Ex. 66. 

**I therefore admit into evidence CMS Exs. 1-136**. 

In the absence of any objections, **I admit into evidence P. Exs. 1-9**. 

**Decision on the written record**.  My standing order directed the parties to exchange, as a proposed exhibit and in the form of an affidavit or written declaration, the written direct testimony of any proposed witness.  Acknowledgment and Pre-hearing Order at 3, 5 (¶¶ 4, 8) (April 20, 2021).  The order also directed each party to indicate whether it wanted to cross-examine the opposing party’s witnesses by “identifying the witness(es) [it] wants to cross-examine.”  Order at 5 (¶ 9).  The order pointed out that a hearing would be necessary only if a party files admissible, written direct testimony, and, in compliance with the order, the opposing party asks to cross-examine.  Order at 4 (¶ 10). 

Petitioner lists one witness and provides his written direct testimony.  CMS has not asked to cross-examine him.  *See* CMS Rebuttal. 

CMS lists multiple witnesses and provides their written direct testimony.  Petitioner did not identify any particular witnesses that it wants to cross-examine.  Its vague allusion to “reserv[ing] the right to cross-examine any witnesses called by CMS” does not comply with the standing order’s explicit direction that it *identify*any witness it wants to cross-examine.  Consistent with the regulations that authorize me to do so, the order is designed

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to narrow the issues and identify the evidence and witnesses to be presented at the hearing.  *See* 42 C.F.R. § 498.47(a).  Petitioner may not subvert this valid purpose by refusing to identify a witness for cross-examination and expecting to do so at some unspecified later time.  Parties are simply not free to rewrite judges’ orders.7 

Because the witnesses’ direct testimonies are already in the record, and no witnesses will be cross-examined, an in-person hearing would serve no purpose.  This matter may therefore be decided based on the written record.  *HeartFlow, Inc.,*DAB No. 2781 at 16-17 (2017), (citing *Vandalia Park,* DAB No. 1940 at 28-29 (2004), *aff’d, Vandalia Park v. Leavitt,* 157 F. App’x 858 (6th Cir. 2005)).8 

**Issues**

In its hearing requests, Petitioner challenged every deficiency citation, every determination based on a deficiency citation, and every remedy.  These are not adequate hearing requests.  A hearing request is supposed to identify the *specific* issues, and the findings of fact and conclusions of law with which the affected party disagrees and *specify* the basis for contending that the findings and conclusions are incorrect.  42 C.F.R. § 498.40(b).  Petitioner’s all-encompassing but unfocused requests do not meet the specificity requirements of the regulation, although they are adequate to preserve Petitioner’s hearing rights so long as it eventually specifies what it is appealing.  *Carlton at the Lake,* DAB No. 1829 (2002); *Alden Nursing Center – Morrow,* DAB No. 1825 (2002). 

In its brief, Petitioner asks that I address “the most serious of the Medicare participation requirements,” which it identifies as the deficiencies cited under sections 483.12, 483.25, 483.35, and 483.80.  P. Br. at 3, 5.  In challenging the amount of the CMP, Petitioner, without explanation, asserts that it “anticipates the deletion of these [additional] citations” that have not been addressed.  P. Br. at 21.  CMS has indicated no interest in deleting the

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citations, and, because Petitioner presents no evidence or arguments to rebut multiple findings of substantial noncompliance, those allegations in the statements of deficiencies (along with other evidence) are sufficient to establish a prima facie case that the facility did not disprove or rebut.  *See**Azalea Court,* DAB No. 2352 at 2, 3 (2010), *aff’d*, 482 F. App’x 460 (11th Cir. 2012); *Universal Health Care – King,* DAB No. 2383 at 9 (2011); *Guardian Health Care Ctr.,* DAB No. 1943 (holding that CMS may make a prima facie showing of noncompliance based on the statement of deficiencies if the factual allegations it contains are specific, undisputed, and not inherently unreliable.”) (citing *Glenburn Home,*DAB No. 1806 at 25 (2002)); *see also* CMS Exs. 12, 13, 14, 15, 16, 17, 18; CMS Br. at 2-3; CMS Rebuttal at 5-7; P. Br. at 3 (limiting the scope of Petitioner’s appeal); P. Br. at 5 (challenging the deficiencies cited under sections 483.12, 483.25, 483.35, and 483.80).  Moreover, as the following discussion shows, many of the cited deficiencies are based on a common set of facts. 

Thus, based on the deficiencies that Petitioner has not pursued, I find that, from August 27 through December 27, 2020, the facility was not in substantial compliance with multiple program requirements, and the CMP must be at least $112 per day.  *See* 42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020). 

The remaining issues before me are: 
                            - From August 27 through December 27, 2020, was the facility in substantial compliance with the following Medicare program requirements: 42 C.F.R. §§ 483.12(a), 483.25, 483.25(d), 483.35, and 483.80;
                            - From August 27 through September 10, 2020, did the facility’s deficiencies pose immediate jeopardy to resident health and safety; and
                            - Are the penalties imposed – $5,090 per day for 15 days of immediate jeopardy and $270 per day for 107 days of substantial noncompliance that did not pose immediate jeopardy – reasonable? 9    

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**Issues that are not before me**.  Petitioner complains about the penalties imposed, as well as some collateral consequences associated with CMS’s deficiency findings.  *See* P. Br. at 3-6.  The regulations limit my jurisdiction.  I may not review CMS’s choice of remedy nor the factors it considered in determining the remedy.  42 C.F.R. § 488.408(g)(2); 498.3(d)(14); *Beverly Health & Rehab. Servs., Inc. v. Thompson*, 223 F. Supp. 73, 111 (D.D.C. 2002) (holding that the “determination of what remedy to seek is beyond challenge.”); *see San Fernando Post Acute Hospital,* DAB No. 2492 at 9-10 (2012) (citing *Shalala v. Ill. Council on Long Term Care*, 529 U.S. 1 (2000) (rejecting the assertion that any and all challenges to enforcement decisions are entitled to administrative review)); *Columbus Park Nursing & Rehab. Ctr.,* DAB No. 2316 at 9 (2010), *aff’d sub nom. Columbus Park Nursing & Rehab. Ctr. v. Sebelius,* 940 F. Supp. 2d 805 (N.D. Ill. 2013). 

### Discussion

                            The facility was not in substantial compliance with 42 C.F.R. §§ 483.12 and 483.25 because it did not provide its residents with the goods and services they needed to avoid suffering physical harm, pain, mental anguish, and emotional distress and to attain or maintain the highest practicable physical, mental, and psychosocial well-being.
10
 

### A.  Program Requirements

**Program requirement:  42 C.F.R. § 483.12 (tags F600, F609, and F610)**.  A facility resident has the right to be free from abuse, neglect, and exploitation.  42 C.F.R. § 483.12.  “Neglect” is defined as the failure of the facility, its employees, or service providers to provide a resident with the goods and services necessary to avoid his/her suffering physical harm, pain, mental anguish, or emotional distress.  42 C.F.R. §§ 483.5, 488.301. 

Among other requirements, the facility must ensure that all alleged violations involving neglect are reported to the facility administrator and other officials (including the state survey agency and adult protective services).  If the events that caused the allegations resulted in serious bodily injury, the alleged violations must be reported immediately, but not later than two hours after the allegation is made; if the events did not result in serious bodily injury, the alleged violations must be reported within 24 hours after the allegation is made.  The facility must have evidence that all allegations are thoroughly investigated; it must prevent further potential neglect while the investigation is in progress; and it must

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report the results of all investigations to the administrator (or designee) and other officials (including the state survey agency) within five working days of the incident.  If the alleged violation is verified, appropriate corrective action must be taken.  42 C.F.R. § 483.12(c). 

**Program requirement:  42 C.F.R. § 483.25 (Tag F684)**.  The statute mandates that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2). 

The quality-of-care regulation characterizes quality of care as a “fundamental principle that applies to all treatment and care provided to facility residents.”  Based on the resident’s comprehensive assessment, the facility must ensure that the resident receives treatment and care in accordance with professional standards of practice, the resident’s comprehensive, person-centered care plan, and the resident’s choices.  42 C.F.R. § 483.25.  The regulation “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  *Sheridan Health Care Ctr.,* DAB No. 2178 at 14 (2008) (citing *Windsor Health Care Ctr*.*,* DAB No. 1902 at 16-17 (2003)); *Woodstock Care Ctr.,* DAB No. 1726 at 3-4 (2000), *aff’d, Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).11

### B.  Facility Policies

A facility’s failure to follow its anti-neglect policy can put it out of substantial compliance with section 483.12(c) (then section 483.13(c)), as can its failure to follow its other policies and procedures where those policies define what a facility deems “the goods and services necessary to avoid physical harm.”  *Avalon Place Kirbyville,* DAB No. 2569 at 9 (2014). 

Similarly, CMS “may reasonably rely on a facility’s policy relating to the care and treatment of its residents as evidencing the facility’s understanding of what must be done to attain or maintain residents’ highest practicable physical, mental, and psychosocial well-being, as required by [42 C.F.R.] section 483.25.”  *Green Valley Healthcare and Rehab. Ctr.,* DAB No. 2947 at 6 (2019) (citing *The Laurels at Forest Glenn,*DAB No. 2182 at 18 (2008)); *North Las Vegas Care Ctr.*, DAB No. 2946 at 6 (2019); *Hanover*

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*Hills Health Care Ctr.,* DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality-of-care requirements in section 483.25.”). 

**Facility policy:  preventing abuse and neglect**.  The facility had in place a policy prohibiting mistreatment, neglect, and abuse of its residents.  Consistent with the regulation, the policy defines neglect as “failure to provide, or willful withholding of adequate medical care, mental health treatment, psychiatric rehabilitation, personal care, or assistance with activities of daily living that is necessary to avoid physical harm, mental anguish, or mental illness of a resident.”  CMS Ex. 26 at 2; CMS Ex. 114 at 3. 

Among the procedures for preventing neglect, the policy calls for orientation and training of employees, covering:  sensitivity to resident needs; what constitutes abuse and neglect; staff obligations to prevent and report abuse and neglect; and (problematically) how to distinguish willful abuse from insensitive staff actions that should be corrected through counseling and additional training; and other topics.  CMS Ex. 26 at 3-4.12 

The policy requires that staff, as part of the assessment process, identify residents with increased vulnerability for abuse or neglect, or who have needs and behaviors that might lead to conflict.  Through the care planning process, staff are to identify any problems, goals, and approaches that would reduce the chances of abuse or neglect. 

The policy also requires employees to report any incident, allegation, or suspicion of potential abuse or neglect to the administrator or to an immediate supervisor, who must immediately report to the administrator.  Upon learning of the report, the administrator (or designee) must initiate an incident investigation.  CMS Ex. 26 at 4.  Nursing staff are responsible for reporting the appearance of suspicious bruises, lacerations, or other abnormalities.  The nursing supervisor is responsible for assessing the resident, reviewing the documentation, and reporting to the administrator (or designee).  If the resident complains of injuries, or if injury is suspected, staff must contact the resident’s physician for instructions.  CMS Ex. 26 at 5. 

Facility employees who have been accused of abuse or neglect will be removed from resident contact immediately, until the results of the investigation have been reviewed by the administrator (or designee).  CMS Ex. 26 at 5.  The policy requires that any incident or allegation of abuse or neglect be investigated.  It directs the administrator to appoint an

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investigator to gather further facts regarding any other incident or pattern “*involving reasonable cause to suspect abuse [or] neglect*.”  *Id*. (emphasis in original). 

According to the policy, “if mistreatment has occurred,” the facility must inform the resident’s representative and the Department of Public Health as soon as possible, within 24 hours.13  Within five working days, *after the initial report*, a final report will be sent to the Department of Public Health.  CMS Ex. 26 at 6 (emphasis in original).14 

**Facility policy:  wound care**.  The stated objective of the facility’s wound care policy is to protect a wound from contamination and to control bleeding.  The policy recognizes that wounds are susceptible to infection and bleeding and emphasizes that “**Standard Precautions Must Be Followed During Care of Wounds**.”  CMS Ex. 29 at 1 (emphasis in original).  The policy directs staff to observe all wounds and notify the physician of “signs of *infection*, *swelling* of the affected part, *redness* of the affected part, and a *sensation of heat*, along with throbbing *pain*, *tenderness*, *fever*, evidence of *pus*, or *red streaks* leading from the wound.  CMS Ex. 29 at 2 (emphasis in original). 

The policy includes strict instructions for wound care and documentation: 
                            - Follow physician’s orders for wound care.  The orders should include specific instructions, such as cleansing solution (if any), name of the medication to apply, site of application, frequency of treatment, and duration of treatment. 
                            - All wound treatment should be done in an aseptic manner, employing standard precautions throughout.  If ordered by the physician, “complete sterile technique” must be used. 
                            - All contaminated material must be disposed of in biohazard waste containers. 
                            - Staff must document , on the Treatment Administration Record (TAR), wound care  “each time the treatment is done.”   
                            - Current  wound status must be documented no less than once a week .  It should be documented on the TAR, in the space provided, or in the nurse’s notes as they occur.  Facilities using EHR (Electronic Health Records) will complete a “Weekly Treatment (Non Pressure Ulcer) Documentation Observation.”  

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                            - Wound changes and other pertinent observations must be documented in the nurse’s notes as they occur . 
                            - The physician must be notified of any change in the wound status. 
                            - The presence of the wound and the interventions must be addressed in the resident’s care plan.  The physician’s order sheet will reflect the treatment plan for wound care. 
                            - In the case of drainage containing pus, and/or presence of odor, the physician should be consulted regarding culture and the sensitivity of the wound. 
                            - CDC guidelines serve as the authority for necessary isolation procedures. 

CMS Ex. 29 at 2. 

**Facility policy:  pressure ulcer treatment and management**.  The facility had an additional policy for treating and managing pressure ulcers.  The policy requires that residents with pressure ulcers have a physician’s order for treatment.  Staff are to *maintain a description of the wound on a weekly basis*.  A licensed nurse is required to *document the treatment as given on the TAR*.  The resident’s care plan must include the “individual description of the treatment plan.”  Staff are required to notify the physician when assessments indicate a lack of progress in healing.  Because residents with pressure ulcers are at high risk, all components of the “At Risk protocol” must include:  pressure relieving devices, nutritional support, assistance with mobility, including repositioning and range of motion, as outlined in the At Risk protocol.  Finally, the licensed nurse is required to perform treatment, using standard precautions for infection control and following CDC guidelines for isolating precautions, as necessary.  CMS Ex. 89 (emphasis added). 

**Facility policy:  Hoyer (mechanical) lift**.  The facility had a policy for using a Hoyer (mechanical) lift.  The policy describes the purpose of the lift:  to assist staff to lift and move a resident as safely and easily as possible.  It should be used for heavy or disabled residents.  *Two staff members are required for the procedure*.  The procedure requires the lift itself and a Hoyer *sling of appropriate size*.  CMS Ex. 38 (emphasis added). 

**Facility policy:  charting**.  The facility’s policy requires that staff record, in the resident’s medical record, all services provided, and any changes in the resident’s condition.  This includes all observations, all medications given, and services performed.  The entries must be recorded by the person rendering the service.  *All incidents, accidents, or changes in the resident’s condition must be recorded*.  The clinical record

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should contain only objective, factual information that pertains to the direct care of the resident.  CMS Ex. 31 (emphasis added). 

**Facility policy:  comprehensive care plans**.  The facility’s policy for comprehensive care plans describes its objective as:  “To develop a comprehensive, person-centered plan of care, consistent with the resident’s rights, that includes measurable objectives and timeframes to meet the resident’s medical, nursing, and mental and psychosocial needs.”  CMS Ex. 32 at 1.  Among other requirements, the plan must be developed with the input of the interdisciplinary team, which includes (at a minimum):  the attending physician; a registered nurse responsible for the resident; a nurse aide responsible for the resident; a member of the food and nutrition services staff; the resident and the resident’s representative (to the extent practicable); and other appropriate staff or professionals in disciplines, as determined by the resident’s needs or as requested by the resident.  CMS Ex. 32 at 1.

The plan must include: 
                            - Services that are to be furnished to attain or maintain the resident’s highest practicable physical, mental, and psychosocial wellbeing, while preventing decline when possible;
                            - Areas of potential risk to the resident, with interventions to eliminate or reduce risk;
                            - The identity of the professional services responsible for each element of care;
                            - Measurable objectives and timeframes;
                            - Services that are recommended but withheld due to the expressed wishes of the resident or the representative, allowing the right to refuse treatment or services ;
                            - Any specialized services or specialized rehabilitative services the nursing home will provide as a result of the PASSAR (pre-admission screening and resident review) recommendations and, if the facility’s assessment is not consistent with the recommendations contained within the PASSAR, the rationale is documented in the resident’s clinical record;
                            - The resident’s goals and desired outcomes;
                            - The resident’s potential for discharge and goals to achieve desired outcomes;

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Finally, the policy requires that care plans be revised as changes in the resident’s condition dictate, but no less than quarterly.  CMS Ex. 32 (emphasis added). 

### C.  The Facility’s Repeated Failures to Provide Its Residents with Necessary Care and Services. 

**Resident 1 (R1)** (September 16 survey).  R1 was a 43-year-old woman, admitted to the facility on April 2, 2020.  She suffered from a long list of impairments, including chronic kidney disease, peripheral vascular disease, severe obesity, end stage renal disease, and type 2 diabetes with diabetic neuropathy.  Because of “extreme sensitivity,” she was not on insulin.  Her cognition was unimpaired.  CMS Ex. 43 at 22, 26; CMS Ex. 124 at 4 (Knight Decl. ¶ 12); P. Ex. 5 at 2, 4.  

The evidence of R1’s condition and treatment (or lack thereof) is largely undisputed.  When R1 was admitted from the hospital, she had diabetic ulcers on both feet, which were not then infected.  CMS Ex. 12 at 17; CMS Ex. 43 at 1, 2, 24; CMS Ex. 124 at 3-4 (Knight Decl. ¶ 12).  Her hospital transfer orders, dated April 2, 2020, indicate that her wounds were to be followed by podiatry.  Treatment orders included the following:  cleanse bilateral heels with Dakins solution, apply Silver Sulfadiazine, cover with a non-adherent pad, and wrap with gauze three times a week.  CMS Ex. 12 at 15; CMS Ex. 43 at 173; CMS Ex. 124 at 4 (Knight Decl. ¶ 12). 

The facility’s TARs document that a nurse practitioner assessed R1’s wounds immediately prior to her admission to the facility.  In a late entry to the records, dated April 3, 2020, the nurse practitioner describes the resident’s “wounds to feet bilaterally” and indicates that medication was applied on April 2, and the wounds were wrapped in gauze.  CMS Ex. 43 at 100.  Thereafter, however, the nurse practitioner’s notes do not mention the foot wounds.  CMS Ex. 124 at 4 (Knight Decl. ¶ 13).  In an interview with Surveyor Jayme Knight, R.N., the nurse practitioner confirmed that she had not examined R1’s feet while the resident was in the facility.  She said that the nurses were responsible for giving R1 her foot treatments when the wound nurse could not.  CMS Ex. 12 at 19; CMS Ex. 124 at 4 (Knight Decl. ¶ 15). 

Nor was R1’s condition adequately followed by any other health care professional.  R1 did not see a podiatrist until more than four months after her admission; she seldom saw the wound care nurse and, even as the condition of her foot ulcers deteriorated, staff failed to follow basic treatment orders – they did not clean and dress wounds as ordered. 

At the time of R1’s admission, staff recorded the presence of the ulcers, but did not measure or otherwise assess them.  CMS Ex. 12 at 15; CMS Ex. 43 at 5, 11-12; CMS Ex. 124 at 4 (Knight Decl. ¶ 12).  In fact, her electronic health record (EHR) shows that the facility wound nurse did not see and assess the resident’s wounds until April 13, 2020, 11 days after her admission.  The wound consultant service did not see and assess her

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wounds until June 30, 2020.  CMS Ex. 12 at 15-16; CMS Ex. 43 at 20, 42, 107; CMS Ex. 124 at 4 (Knight Decl. ¶ 12).  R1 did not see the podiatrist at the wound clinic until August 18, 2020. 

The wound nurse explained to Surveyor Knight that she was unable provide R1 with the level of wound treatment the resident required.  Although hired in March 2020 to be the wound nurse, she worked as a floor nurse until March 23.  She was on medical leave until April 13.  When she returned, she worked as a floor nurse for five weeks.  In May, the facility’s Director of Nursing (DON) walked out, and the wound nurse was assigned DON duties.  She was also doing weekly [Covid] testing, “which only [left] her Wednesday through Friday to work with wounds.”  CMS Ex. 12 at 19-20.  That the wound nurse made these statements is undisputed.  *See**Beatrice State Developmental Ctr.,* DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have but did not present employee testimony that refuted the statements the surveyors claimed they made);*Omni Manor Nursing Home,* DAB No. 1920 at 11 (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).  Moreover, her explanation lends support to CMS’s assertion that facility lacked adequate nursing staff.  *See* 42 C.F.R. § 483.35 (discussed below).15 

When, on April 13, the wound nurse finally assessed R1’s wounds, she described a wound that was 6 cm. long and 7.5 cm. wide.  Its depth could not be measured but it was “full thickness: through [the] dermis [and] down to subsequent tissue, muscle.”  The nurse described the “exudate” (fluid emitted by the wound) amount as moderate and serosanguineous (pale red to pink, thin and watery) and the tissue type as “granulation.”  She found no undermining or tunneling.16  The skin surrounding the area was dry and thin, with edema (swelling).  CMS Ex. 43 at 20-21.  Thereafter, the wound nurse assessed the wound sporadically (on April 23, May 6, June 3, June 10, June 24, June 30, and July 15), not weekly, as required by the facility’s policies.  CMS Ex. 43 at 15-20; *see* CMS Ex. 29 at 2; CMS Ex. 89. 

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On two occasions, (June 19 and July 26, 2020), R1 was sent to the hospital for other reasons, and, while she was there, her wounds were assessed.  On **July 26, 2020**, she was admitted to the hospital with chest pains.  An x-ray of her heel was taken because of concerns that she was suffering from osteomyelitis (inflammation in the bone caused by infection).  She was sent for an MRI, followed by a bone biopsy, again because of osteomyelitis concerns.  Her physician concluded that she was at high risk for limb loss because of her peripheral vascular disease.  He recommended consultation with either interventional cardiology or a vascular surgeon.  CMS Ex. 43 at 47.  The consultation did not occur.  The DON told surveyors that R1 left the facility (against medical advice) before it arranged the vascular consult.  CMS Ex. 12 at 19.  But the facility had had ample time to arrange the consult.  R1 did not leave the facility until August 21, almost four weeks after her physician called for a consult.  CMS Ex. 43 at 1.  R1 told surveyors that she left because “they weren’t taking care of me like they were supposed to.”  CMS Ex. 12 at 21. 

R1 finally saw a podiatrist at the wound clinic on August 18, 2020.  The podiatrist reported that, after her bone biopsy, R1’s betadine dressings were supposed to be changed daily.  R1 complained that nursing staff had not been doing this, and she was afraid that her leg had gotten worse as a result.  She said that she had questioned and argued with the nurses about their failing to change the dressings as ordered and that she was concerned about losing her leg.  “She became very emotional during the visit.”  The podiatrist described “[d]ecubitus heel ulceration with dry stable eschar (dead tissue) noted to the medial and central aspect of the heel” and a “fibrotic rim (hard, rigid to touch) to the eschar.”  The wound was unstageable (active) and was seven cm long, 6.4 cm wide, and 0.5 cm deep.  Drainage was moderate and described as “yellow, malodorous, and green.”  CMS Ex. 43 at 42-43. 

The podiatrist also recommended that R1 see a vascular surgeon.  He again prescribed betadine dressing changes daily, with assistance from the facility nursing staff.  CMS Ex. 43 at 29, 44. 

The TARs confirm that R1’s complaints were valid.  From April through July 2020, staff regularly skipped treating her wounds.  The facility administration could not or would not provide TARs for August 2020 – which, by itself, puts the facility out of substantial compliance.  CMS Ex. 43 at 173-179; CMS Ex. 12 at 19; CMS Ex. 124 at 4 (Knight Decl. ¶ 13). 

As noted above, the wound nurse admitted that she worked on wound treatment only three days a week and was not able to document weekly wound treatment for R1.  Review of the wound nurse’s “weekly” wound tracking notes confirm that she updated them sporadically.  CMS Ex. 12 at 19-20; CMS Ex. 43 at 107-117; CMS Ex. 124 at 4 (Knight Decl. ¶ 15).  Another nurse confirmed that R1 had osteomyelitis in her right foot wound, but staff were not treating the wound.  CMS Ex. 12 at 18; CMS Ex. 124 at 4

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(Knight Decl. ¶ 15).  Again, that statement is unrefuted.  *See Beatrice State,* DAB No. 2311 at 17, 18.  

R1’s lower right leg was amputated on August 30, 2020.  CMS Ex. 12 at 17. 

Petitioner does not challenge CMS’s assertions that the facility delayed assessing R1’s wounds and that staff failed to clean and change her dressings as ordered.  Instead, Petitioner argues that the resident was herself responsible for her deteriorating condition because she was noncompliant with her diet and because she often left dialysis early or refused it altogether.  P. Br. at 12, citing P. Ex. 5 at 11-17.  According to Petitioner, the facility was not at fault for R1’s deteriorating condition because it was caused by the resident’s comorbidities as well as her refusals to accept treatment. 

I discuss below the facility’s obligations to a resident who refuses necessary care.17  But I need not reach that issue in considering whether the facility violated sections 483.12 (neglect) and 483.25 (quality of care) with respect to R1.  Her treatment was supposed to be followed by a podiatrist, but she did not see one until four months after her admission.  The wound nurse saw her only sporadically.  The facility had nearly four weeks in which to arrange a critically important consult with a vascular surgeon but did not do so.  *Staff failed to follow treatment orders that R1’s wounds be cleaned and dressed*.  No evidence suggests that R1 resisted or refused any of this.  In fact, the opposite is true.  The evidence shows that R1 repeatedly asked staff to clean her wounds and complained bitterly that they refused to do so.  CMS Ex. 43 at 42, 44 (complaining that staff had not been changing her dressings despite her arguing with them about it). 

R1 was unquestionably at high risk for skin breakdown, and her comorbidities contributed substantially to the loss of her leg.  However, this does not relieve the facility of its obligation to assess and treat her wounds.  Indeed, because she was at such risk, it was all the more important that staff carefully follow all treatment orders.  The question is:  did the facility “take all necessary precautions” to promote healing, prevent infection, and prevent additional wounds from developing.  If it did so, and the wounds became worse, I could find no deficiency.  But where, as here, the evidence establishes that the facility fell short of taking all necessary precautions, it has neglected the resident and violated the quality-of-care regulation.  *Heritage House of Marshall Health & Rehab.*, DAB No. 3035 at 11-12 (2021); *Fireside Lodge Retirement Ctr.,* DAB No. 2794 at 12 (2017) (holding that the issue is not whether a pressure sore could be expected to heal, but rather whether the facility staff provided the care and services necessary to promote

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healing); *see Senior Rehab. & Skilled Nursing Ctr.,* DAB No. 2300 at 13-14 (2010), *aff’d, Senior Rehab. & Skilled Nursing Ctr. v. HHS*, No. 10-60241 (Dec. 20, 2010); *Koester Pavilion,* DAB No. 1750 at 32 (2000). 

Because the facility did not assure that R1 was examined and treated by the appropriate health care professionals and did not assure that its staff cleaned and dressed her wounds as ordered, the facility was not in substantial compliance with sections 483.12 and 483.25 in its treatment of R1.  

**Resident 40 (R40)** (September 16 survey).  R40 was a 58-year-old woman, admitted to the facility on December 6, 2019, suffering from a long list of impairments, including stage 5 chronic kidney disease/end-stage renal disease, type 2 diabetes, systemic lupus, morbid obesity, and recurrent depressive disorders.  She had skin ulcers in her abdominal folds.  She had a “pain disorder with related psychological factors.” CMS Ex. 54 at 1.  She required dialysis three times a week, on Monday, Wednesday, and Friday, which the facility provided in-house.  CMS Ex. 54 at 2; CMS Ex. 64; P. Ex. 4 at 1-2. 

At the time of her admission, the facility did not adequately assess R40 for pain.  Her assessment confirms that she experienced pain, for which medications were administered but leaves blank the actual pain assessment.  CMS Ex. 54 at 19-21. 

Her care plan identified her as at risk for pressure ulcers related to her immobility, diabetes, and end stage renal disease.  The plan does not appear to address R40’s peculiar needs but instead includes standard interventions for preventing pressure sores.  For example, it directs staff to “avoid shearing” the resident’s skin during positioning, transferring, and turning.18 This is a common intervention for avoiding pressure sores.  However, according to R40’s assessment, her problems significantly affected staff’s ability to avoid shearing.  The resident required moderate to maximum assistance in moving.  “Complete lifting without sliding against sheets is impossible.”  CMS Ex. 54 at 18.  The care plan gives staff no instructions as to how, in light of this serious complication, they were supposed to “avoid shearing.”  *See Sheridan Health Care Ctr.,* DAB No. 2178 at 37 (requiring that care plans provide staff with meaningful direction and strategies for meeting the plan’s objectives). 

The plan also directed staff to check and change or toilet the resident before and after meals and as needed.  They were required to conduct a systematic skin inspection, paying particular attention to bony prominences.  Again, this common intervention for preventing pressure ulcers does not seem to address R40’s real risk.  She was at risk for developing sores between the folds of her skin, not on her bony prominences.  But the

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initial care plan does not direct staff to pay particular attention to the areas between the folds of her skin. 

Staff were also required to keep the resident as clean and dry as possible, minimizing skin exposure to moisture.  The plan directs staff to provide incontinence care after each incontinent episode; to reduce friction injuries by using lubricants, protective film, protective dressings, and/or protective padding, as ordered.  They were to report any signs of skin breakdown (sore, tender, red, or broken areas); turn and reposition the resident frequently; use absorbent, skin-friendly pads/briefs to maintain the resident’s personal hygiene and dignity.  They were to use a moisture barrier product to her perineal area.  P. Ex. 4 at 14-16. 

To the extent that any of these interventions were implemented (and the evidence shows that many of them were not consistently implemented), they did not prevent R40 from developing additional skin wounds.  As of June 2020, she had an open wound in her left lower calf and a pressure ulcer on her left lower abdomen that was surrounded by multiple blisters.  She required daily skin checks, skin care, and wound treatment.  CMS Ex. 54 at 12-13, 37; CMS Ex. 62 at 3; CMS Ex. 126 at 4 (Boyer Decl. ¶ 15).  Treatment orders directed staff to clean, every shift, R1’s “left pannus” (the area of excess skin and fat that hangs over the pubic region) with soap and water and pat dry; powder between the folds; and place pillowcases in the folds of her skin, to keep it separated and dry.  Staff were supposed to clean and dry her leg creases daily, change a disposable pad on her left hip up to three times a day (as needed), and apply Mepilex (an absorbent foam dressing) to her left back thigh and sacrum.  CMS Ex. 54 at 13, 38; CMS Ex. 126 at 4 (Boyer Decl. ¶ 15). 

A June 30, 2020 entry into R40’s care plan identified the ulcer on R40’s left lower abdomen and directed staff to assess and record the condition of the skin surrounding that ulcer.  Staff were to assess the ulcer for location, stage, size (length, width, depth), the presence/absence of granulation tissue and epithelization (restoration of skin integrity).  They were to conduct a systematic skin inspection and to report any signs of further skin breakdown.  P. Ex. 4 at 21.  The plan does not include the specifics listed in R40’s treatment orders (*see* CMS Ex. 54 at 13, 38) but directs staff to keep the skin as clean and dry as possible and to minimize exposure to moisture.  Staff were to keep linens clean, dry, and wrinkle-free, and to turn and reposition the resident frequently.  P. Ex. 4 at 21-22.  The plan also instructs them to observe and report signs of cellulitis (localized pain, redness, swelling, tenderness, drainage, fever, chills, malaise, tachycardia, and hypertension) and of sepsis (fever, lassitude or malaise, change in mental status, tachycardia, hypotension, anorexia, nausea, vomiting, diarrhea, headache, lymph node tenderness/enlargement).  P. Ex. 4 at 22. 

Contrary to the instructions in the care plan (and facility policies), staff did not conduct “systematic skin inspections,” and they did not “report any signs of further skin

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breakdown.”  R40’s shower assessments should have documented her multiple (and growing number of) pressure wounds, but they did not.  CMS Ex. 54 at 39-52; CMS Ex. 126 at 5 (Boyer Decl. ¶ 18); *see* CMS Ex. 29 at 2; CMS Ex. 89. 

Surveyor Elizabeth Boyer, R.N., interviewed R40, who complained that she often had trouble getting out of bed because the facility did not have enough staff to do it.  CMS Ex. at 10-11.  She said that she was “lucky to have her treatment done once a month” and that “no one ever shows up on the weekend.”  CMS Ex. 126 at 4 (Boyer Decl. ¶ 15).  That she was provided treatment just once a month may have been a bit of an exaggeration, but Surveyor Boyer’s review of the resident’s wound tracking sheets confirmed that staff were not providing skin treatments daily, as ordered.  CMS Ex. 126 at 4 (Boyer Decl. ¶ 15), citing CMS Exs. 54, 62.  Between June and September 2020, R40’s condition deteriorated.  CMS Ex. 62 at 3, 5, 10, 15, 16, 18, 21, 28, 32; CMS Ex. 126 at 4 (Boyer Decl. ¶ 15). 

On September 30, 2020, R40 was discharged to Select Specialty Hospital.  P. Ex. 4 at 1, 89. 

Petitioner again blames the resident for her deteriorating condition and the lack of care.  Petitioner points out that the resident weighed more than 400 pounds and was noncompliant with her diet.  P. Br. at 10.  She regularly refused treatment, both dialysis and skin care, complaining that she was in too much pain or that the facility did not have the appropriate Hoyer sling so that she could be transferred safely.  P. Br. at 9-10.19 She refused showers.  CMS Ex. 54 at 39-52.  Petitioner implies that R40’s reasons for refusing care were bogus, that she was merely looking for an excuse – any excuse – to avoid treatment.  *See* P. Br. at 9-11. 

I accept that R40 was a deeply troubled and difficult resident.  She was severely morbidly obese, and she complained of constant pain, which is not surprising, considering the condition of her skin.  From the time of her admission, she frequently refused dialysis and other treatments and services, complaining of pain or inadequate devices for transferring her.  CMS Ex. 54 at 28-32; 39-52; P. Ex. 4 at 11-12.  I have no doubt that just transferring her from her bed was an ordeal for both R40 and for the staff who were assigned to assist her, and it was no doubt much easier to leave her in bed.  As noted above, the facility’s Hoyer policy requires that two staff members operate the lift and that

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a sling “of appropriate size” be used.  Otherwise, I see no instructions – in R40’s care plan or elsewhere – for transferring the resident (e.g., number of staff to assist, appropriate equipment). 

For two reasons, I reject Petitioner’s suggestion that it is not accountable for failing to provide R40 with the goods and services she needed:  1) there are well-documented instances in which the facility did not have the equipment it needed to transfer the resident so that she could receive necessary care; and 2) the facility was not free to accept the resident’s refusals of care without considering interventions to address that problem.  

**Facility at fault**.  First, the facility was plainly at fault for failing to provide needed care in these instances: 
                            -  Progress notes establish that, on March 23, 2020, R40 “refused [to go to dialysis] because the sling was not the right one and neither was the Hoyer [lift].”  P. Ex. 4 at 3.  Petitioner has presented no documentation or testimony to establish that R40’s complaint was erroneous.  To the contrary, the March 23 progress note supports the finding that R40’s concerns were well-founded, noting that the DON was “making sure [that] appropriate equipment is ready for the morning[,] so patient does not miss Dialysis.”  *Id*.  It does not say (and no witness claims) that the appropriate equipment was available on March 23. 	Petitioner suggests that R40’s insistence on “her preferred sling” was not a legitimate reason for refusing dialysis.  P. Br. at 9.  In fact, the inverse is true:  to be transferred safely, a large resident, like R40, required the Hoyer lift with a sling of appropriate size.   See  CMS Ex. 38.  The facility’s unwillingness or inability to provide the resident with a fairly simple piece of equipment so that she would be comfortable and safe while being transferred was unreasonable.   See  discussion below.  
                            -  On August 13, 2020, the facility did not have sufficient staff or the equipment needed to get R40 out of bed so that she could go to her dialysis appointment.  CMS Ex. 12 at 10-11; CMS Ex. 126 at 4 (Boyer Decl. ¶ 13).  The dialysis nurse confirmed that the facility did not have the sling it needed to transfer R40 out of bed.  Alarmed that she would be seriously harmed without the dialysis, the nephrologist sent her to the hospital.  “We do try to accommodate the lack of staff time or equipment if the residents cannot get in at their time for dialysis.  We cannot do anything if they cannot get them out of bed.”  CMS Ex. 12 at 11.  The nephrologist explained that he sent R40 to the hospital because the facility did not have a sling to transfer the resident out of bed.  It was Friday, and she could not safely go the entire weekend without dialysis.  CMS Ex. 12 at 11; CMS Ex. 54 at 1; CMS Ex. 126 at 4 (Boyer Decl. ¶ ¶ 13, 14).  R1 went to the hospital the 

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following day, August 14, and underwent dialysis.  No evidence suggests that R40 refused to be transferred by the Emergency Medical Technicians (EMTs).
                            -  R40 was hospitalized for eight days, returning to the facility on August 22, 2020.  Surveyor Boyer could not find in her medical record any orders for skin care treatment from August 23 through 31, 2020.  The facility could not produce any skin management report or assessment after the resident’s return.  The closest thing Surveyor Boyer saw to an “assessment” was an entry made by a licensed practical nurse (LPN) at the time of R40’s readmission.  The LPN wrote that the resident’s wounds had not changed during her hospitalization.  The entry was not an adequate assessment; it included no measurements or wound locations.  In any event, an LPN is not qualified to evaluate wounds.  CMS Ex. 12 at 13; CMS Ex. 126 at 5 (Boyer Decl. ¶ 16).  The wound nurse explained that she had not worked on August 22.  She also confirmed that staff did not enter the hospital’s wound treatment orders into the Resident’s medical record until August 31, and *R40 went a full nine days without receiving any wound care*.  When finally assessed, the resident had another open area on her right abdominal apron.  CMS Ex. 12 at 11; CMS Ex. 54 at 27; CMS Ex. 126 at 4-5 (Boyer Decl. ¶ 16).  
                            -  On September 1, 2020, Surveyor Boyer observed R40’s skin care treatment.  She noted that the resident had many new wounds on her abdominal skin folds, which were far worse than indicated in her records.20  R40 had cellulitis on her lower left leg.  She had multiple weeping wounds on the back of her right thigh, some of which were bleeding.  Her lower abdomen was covered with a thick white odorous substance and more open wounds.  Dried stool was down the back of her left leg, and a draining blood blister was on her right upper abdomen.  During the procedure, R40 wanted to stop because she was in so much pain.  Notwithstanding the new wounds, the facility did not complete a wound assessment.  CMS Ex. 12 at 12; CMS Ex. 54 at 34; CMS Ex. 126 at 5 (Boyer Decl. ¶ 17). 
                            -  On September 1, 2020, R40 was unable to go to dialysis because she was in extreme pain from a festering wound to her lower left belly.  CMS Ex. 12 at 13. 

In a curious exchange, when EMTs were transporting R40 to the hospital on September 17, 2020, they refused to transport the resident without the Hoyer sling under her.  In a note suggesting that the facility had a limited number of slings, one of the facility’s LPNs

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insisted that the sling was not to leave the facility.21  The EMTs ignored her and transported the resident with the sling.  P. Ex. 4 at 10. 

**Inadequate response to R40’s refusing treatment and care**.  The facility did not adequately assess and plan for two of R40’s significant and related problems – her refusing treatment and her significant pain, which was one of the underlying reasons she proffered for refusing treatment.  

A facility must specifically assess and plan for a resident’s refusing to accept the interventions listed in her plan of care.  42 C.F.R. § 483.21(b).22 Unless it modifies a resident’s care plan to address the problem, it cannot avoid a deficiency citation by claiming to have been honoring the resident’s wishes.  *White Sulphur Springs,* DAB No. 2520 at 15-16 (2013).  The facility’s policy reflects this requirement; it mandates that a resident’s care plan include recommended services that are withheld “due to the expressed wishes of the resident . . . allowing the right to refuse treatment or services.”  CMS Ex. 32. 

From the time of her admission, R40 was refusing dialysis from two (February 2020) to eight times per month (July 2020).  P. Ex. 4 at 11-12.  The progress notes documenting her refusals are sparse, but they suggest two primary reasons for her refusals:  1) inadequate equipment and insufficient staff to assist her in transferring and 2) pain. 
                            - As noted above, on  March 23, 2020 , R40 refused dialysis, complaining that the sling and lift that staff proposed to use were wrong (which staff acknowledged was true).  P. Ex. 4 at 3. 
                            - On  July 10, 2020 , at 5:47 a.m., the LPN on duty persuaded R40 that she needed to go to dialysis, despite her misgivings about the cleanliness of the lift pad.  P. Ex. 4 at 4. 23  However, later that morning (at 6:52 a.m.), she refused to go, complaining that the facility did not have the appropriate lift.  A different LPN “educated [her] of many avail,” (presumably that there were different types of lifts), but the resident still refused to go.  P. Ex. 4 at 5. 

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                            - On  July 21, 2020 , she refused to go to dialysis, complaining of pain.  An LPN and dialysis staff “reapproached,” but nothing indicates that anyone addressed her complaints of pain.  P. Ex. 4 at 6. 
                            - On  July 23, 2020 , she again refused dialysis, complaining of pain.  The LPN administered her scheduled Hydromorphone, but the resident said that it was not helping.  P. Ex. 4 at 7.  Notwithstanding the instructions in her care plan that nursing staff monitor and evaluate the effectiveness of pain interventions (see below), no evidence suggests that staff addressed the question of whether her medications were effective. 

R40 also regularly refused showers, further jeopardizing the condition of her skin.  For the most part, no reasons are provided for her refusals.  CMS Ex. 54 at 39-52; CMS Ex. 126 at 5 (Boyer Decl. ¶ 18).  A December 12, 2020 entry indicates that R40 wanted cardboard taped to the shower chair (which the facility refused to do, for safety reasons), but it does not indicate why she wanted that.  Knowing the resident’s reasons for wanting the change might have given the facility some insight into how it could have made showering more acceptable to R40.  Again, however, it seems that no one considered this.  P. Ex. 4 at 45. 

Although R40’s refusing treatment was a longstanding problem, I found no interventions to address the problem until **September 13, 2020**, nine months after her admission.  On that day, an entry into her care plan notes that she refused treatments because of pain.  The intervention called for the nurse to perform a medication review.  P. Ex. 4 at 17, 23.  I see no evidence of a medication review. 

From the time of her admission, R40’s care plan identified her complaints of chronic pain as a problem and directed staff to acknowledge that the pain is “unique and believable.”  The plan recognized that the resident refused treatments because of pain.  P. Ex. 4 at 23. The plan listed multiple interventions for the pain, most of them some variation of directing nursing staff to “monitor” or “assess.”  *See* P. Ex. 4 at 23 (“assess the effects of pain on the resident”); P. Ex. 4 at 24 (“assess past effective and ineffective pain relief measures”; “evaluate effectiveness of pain management interventions” and “adjust if ineffective or adverse side effects emerge”); P. Ex. 4 at 25 (“monitor and record any complaints of pain:  location, frequency, effect on function, intensity, alleviating factors”; and “monitor and record any non-verbal signs of pain (e.g., crying, guarding, moaning, restlessness, grimacing, diaphoresis (heavy sweating), withdrawal, etc.)”); P. Ex. 4 at 26 (“monitor for presence of pain/intolerance during self care.”).  

The record includes virtually no evidence of this “monitoring” and “assessing.”  At most, an occasional progress note will reflect the resident’s complaints of pain.  However, the plan offers staff no meaningful guidance as to how staff should respond. 

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R40’s care plans were plainly inadequate.  It is well-settled that, where the resident’s care plan does not address the resident’s needs and provide appropriate interventions, the facility is not providing necessary care and services.  The care plan must include “sufficient guidance to ensure that the services provided promote the plan’s specified objectives.”  *Sheridan Health Care Center,* DAB No. 2178 at 37.  In *Sheridan*, the resident’s care plan identified as problems a resident’s low weight and refusals to eat, but *provided no direction or strategies for* staff to follow in addressing the resident’s injurious fasting behaviors.  The plan’s broad instructions to “encourage oral intake” and “encourage H2O” did not provide staff with “meaningful guidance” to respond effectively and consistently.  The Departmental Appeals Board concluded that the inadequate care plan put the facility out of substantial compliance with the quality-of-care regulation.  *Id*.  Here, the instructions included in R40’s care plan were, if anything, even less effective than those described in *Sheridan*.24 

Further, the facility was also required to revisit its care plans in order to respond meaningfully to changes in the resident’s particular needs.  An interdisciplinary team should have evaluated the interventions planned and considered why the goals were not being met by those interventions.  *Sheridan* at 38-39.  No evidence suggests that this occurred.  If, ultimately, the facility could not provide R40 with the care and treatment she required, it should not have accepted her.  Having accepted her but been unable to meet her needs, it was required to find her a more appropriate placement.  CMS Ex. 126 at 5 (Boyer Decl. ¶ 18). 

From the time she was admitted to the facility, R40 did not receive the care and services that she required.  Her assessments were inadequate.  Her care plan was inadequate.  The facility did not always have the equipment it needed to transfer her safely.  As became apparent early on, facility staff could not or would not implement the care plan’s instructions.  It became obvious that none of the plan’s goals would be achieved – in fact, the resident was deteriorating – yet, the facility did not re-evaluate its approaches in any meaningful way.  These failures violated the regulations and the facility’s policies for preventing neglect, and for treating pressure sores and other wounds.  

Thus, because it neglected R40 and failed to provide her with the care and services she needed, the facility was not in substantial compliance with sections 483.12 and 483.25. 

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**Resident 95 (R95)** (September 16 survey).  Understandably, given the sheer number of problems the surveyors documented, the parties have not addressed in detail every example of a resident’s not receiving adequate care.  And the treatment (or lack of treatment) provided to either R1 and R40 would support finding that the facility was not in substantial compliance with sections 483.12 and 483.25.  In addition, the surveyors found that the facility neglected to provide skin assessments and physician-ordered treatments for R95.  CMS Ex. 12 at 10. 

R95 was a 56-year-old woman, admitted to the facility on August 7, 2020.  She suffered from acute osteomyelitis in both ankles, type two diabetes, stage three chronic kidney disease, heart disease, and severe obesity.  CMS Ex. 60 at 1.  A toe on her right foot had been amputated; she had cellulitis in her left lower leg, and an open area on her left heel. CMS Ex. 12 at 14; CMS Ex. 60 at 20.  Physician orders directed staff to cleanse her feet gently every day and to pack her right-foot wound with soaked gauze and rewrap.  CMS Ex. 12 at 14; CMS Ex. 60 at 5.  

R95 checked herself out of the facility on August 20, 2020, less than two weeks after her admission.  CMS Ex. 12 at 14.  Her treatment records show that she was not bathed during the 13 days she spent at the facility, and no reasons were recorded for staff’s failing to do so.  CMS Ex. 60 at 18-19.  Surveyor Boyer interviewed the resident by telephone on September 4, 2020.  R95 told her that she was not offered a shower the entire time she was at the facility.  No one changed her wound dressing for the first three days she was there; and, in fact, staff changed her dressing only once during the 13 days that she was there.  CMS Ex. 126 at 6 (Boyer Decl. ¶ 21). 

I can tell you that I did not get a shower during my stay at Generations.  I was not offered one the entire time I was at the facility.  No one was “mean” to me, they just would not do anything for me. . . . When I first got to the facility, I laid in bed for two days because they said the lift wasn’t charged.  Now you and I both know it does not take two days to charge a lift.  They just didn’t want to get me out of bed.  I even asked someone why they agreed to take me if they could not take care of me!  The first three days, no one changed my dressing.  They only changed it one time while I was there. 

CMS Ex. 12 at 14-15.  R95 told the surveyor that she checked herself out of the facility because she was afraid that the staff’s neglect would lead to further amputation of her right foot.  She felt safer using home health care.  CMS Ex. 126 at 6 (Boyer Decl. ¶ 22).  

Surveyor Boyer spoke to R95’s podiatrist and confirmed that she should have been receiving daily treatments to both feet.  When the resident came to the wound clinic on August 18, the dressing on her wound was dated August 10, indicating that it had not been changed in eight days.  CMS Ex. 126 at 6 (Boyer Decl. ¶ 21).  This is consistent

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with the resident’s assertion that staff changed her dressing on the third day of her stay but not thereafter. 

The facility would not provide the surveyors with R95’s treatment records, from which I can reasonably infer that it didn’t have any, again violating 42 C.F.R. § 483.20(f) and 483.70(i) – cited deficiencies that Petitioner has not pursued.  CMS Ex. 126 at 6 (Boyer Decl. ¶ 21). 

**Resident 62/18 (R62**(September 16 survey)/ **Resident 18 (R18)** (October 29 survey)).  The same resident was identified as R62 during the September 16 survey and R18 during the October 29 survey.  CMS Ex. 19 at 4; CMS Ex. 79 at 1.  He was a 73-year-old man, admitted to the facility on January 24, 2020, suffering from sepsis, metabolic encephalopathy (a neurologic disorder caused by a systemic illness, such as diabetes, renal failure, or heart failure), chronic respiratory failure, stage 3 chronic kidney disease, and type 2 diabetes.  He was severely obese.  CMS Ex. 93 at 1; CMS Ex. 130 at 2, 3 (Ellis Decl. ¶¶ 10, 15).  

R62/R18 was prone to skin breakdown, with pressure ulcers on his right buttock and right heel.  CMS Ex. 93 at 10-11, 14; CMS Ex. 130 at 10 (Ellis Decl. ¶ 10). 

The resident’s treatment records are sketchy, particularly with respect to his skin condition.  On May 11, 2020, staff were ordered to apply miconazole nitrate (a topical antifungal medication) to his skin folds.  Otherwise, prior to September 13, 2020, nothing in the records suggest that facility staff were addressing the resident’s vulnerability to skin breakdown.  Orders, dated September 13, 2020, direct staff to apply barrier cream to the resident’s buttock “with each incontinent episode” and “every four hours,” as needed.  Every shift, staff were required to apply “skin prep” to both ankles.  CMS Ex. 93 at 9-10. 

The September 16 survey team found that R62 was one of four residents for whom the facility failed to assess a skin condition or provide needed treatment for wounds, resulting in impaired healing and worsening skin conditions.  CMS Ex. 12 at 10; CMS Ex. 124 at 3 (Knight Decl. ¶ 10). 

On October 16, 2020, additional orders directed staff to cleanse the resident’s right buttock wound, apply skin prep to the dark red area, and to apply barrier cream to the resident’s buttock every shift and as needed with each incontinent episode.  CMS Ex. 93 at 10; CMS Ex. 130 at 2 (Ellis Decl. ¶ 11).  Staff were also supposed to apply skin prep to both heels every shift, cover R18’s right lateral heel with silicon bordered foam dressing, and change the dressing once a day on Monday, Wednesday, and Friday, until the wound resolved.  CMS Ex. 93 at 10. 

On October 21, 2020, Surveyor Angela Ellis, R.N., observed the wound nurse treat the wound on R18’s buttock.  She noted that R18’s bandage was soiled and dated October

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17, 2020, indicating that, contrary to his October 16 treatment order, the dressing had not been changed in four days.  Review of the resident’s TAR confirmed that the facility did not provide wound care between October 17 and October 21.  CMS Ex. 15 at 9; CMS Ex. 93 at 1, 10, 24-25; CMS Ex. 130 at 2 (Ellis Decl. ¶ 11).  The wound nurse explained that, when R18 returned from the hospital on October 16, his wound care orders were not transcribed to the TAR (similar to R40’s situation in August 2020).  They were finally transcribed on October 21, 2020.  CMS Ex. 15 at 10; CMS Ex. 93 at 24-25; CMS Ex. 130 at 2-3 (Ellis Decl. ¶ 12). 

An order dated October 21, 2020, directs staff to perform a skin check daily.  CMS Ex. 93 at 10. 

Also disturbing, the *wound nurse* violated basic infection control protocols and facility policies as she treated the resident’s wounds.  Specifically, she applied a skin cleanser to R18’s heel and then began treating the resident’s buttock wound, without changing her gloves or performing hand hygiene (hand washing or use of hand sanitizer), as required by infection control standard precautions and the facility’s policy.  CMS Ex. 15 at 9-10; CMS Ex. 130 at 3 (Ellis Decl. ¶ 13); *see* CMS Ex. 87 at 1 (requiring staff to use hand hygiene via handwashing and alcohol-based hand sanitizers); CMS Ex. 88 at 1-2 (requiring staff to follow “standard precautions” when treating nonintact skin:  wash hands after touching body fluids, secretions, and excretions, whether or not gloves are worn and change gloves between tasks and procedures on the same resident); CMS Ex. 89 (requiring the licensed nurse to follow standard precautions for infection control in treating pressure ulcers).  I discuss below, in more detail, the facility’s multiple deficiencies regarding its infection control practices. 

Petitioner has not denied any of the allegations regarding the facility’s mistreatment of R62/18 and his wounds. 

Even after the September survey, when surveyors cited the facility specifically for its failing to assess and properly treat R62’s wounds, the facility continued to neglect him and failed to provide him with necessary care and services.  This shows that the facility was not in substantial compliance with sections 483.12 and 483.25 and that its deficiencies were so deep-rooted that it could not correct them, even for one resident who had been specifically identified.25 

Nor were these the only documented instances of resident neglect.  I discuss below (under the inadequate staffing section) the plight of Resident 87 (R87), who was left lying on the floor for two hours because the facility lacked the staff and equipment it

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needed to return him to his bed.  CMS Ex. 12 at 74-75; CMS Ex. 58 at 13-14, 69; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 16); P. Ex. 6. 
                            The facility was not in substantial compliance with 42 C.F.R. § 483.25(d) because it did not ensure that its residents were as free of accident hazards as possible and did not adequately supervise residents who were known to be fall risks, even after they had suffered falls.

### A.  Program requirement 

**42 C.F.R. § 483.25(d) (Tag F689)**.26  In keeping with the quality-of-care requirements of the statute and regulation, the quality-of-care regulation mandates that the facility “ensure” that each resident’s environment remains as free of accident hazards as possible and that each resident receives adequate supervision and assistive devices to prevent accidents.  42 C.F.R. § 483.25(d).  The facility must therefore eliminate or reduce a known or foreseeable risk of accidents “to the greatest degree practicable.”  *Del Rosa Villa*, DAB No. 2458 at 7 (2012); *Clermont Nursing & Convalescent Ctr.*, DAB No. 1923 at 9-10, *aff’d sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt*, 142 Fr. App’x. 900 (6th Cir. 2005); *accord,**Briarwood**Nursing Ctr.*, DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”).  A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an “adequate” level of supervision under all the circumstances.  *Deltona Health Care*, DAB No. 2511 at 10 (2011); *Briarwood*, DAB No. 2115 at 5; *Windsor Health Care Ctr.*, DAB No. 1902 at 5 (2003), *aff’d sub nom. Windsor Health Care Ctr. v. Leavitt*, 127 F. App’x 843 (6th Cir. 2005). 

### B.  Facility Policies

**Facility policy:  accident and incident report**.  The facility policy requires staff to document *all accidents and incidents* involving residents, visitors, and employees.  For residents, staff are instructed to: 
                            - provide any necessary emergency care;

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                            - notify the nurse, who must then notify the resident’s physician and family;
                            - follow up for at least 72 hours, which includes taking vital signs, range-of-motion, skin abnormalities, assessing responsiveness, general condition, and changes observed in the injury site;
                            - prepare a complete, thorough, and accurate incident report , and include a general summary of the event in the resident’s progress notes.  Note actual or suspected injuries, that family and physician were notified, and list the interventions implemented at the time of the incident;
                            - notify the state agency of any serious accidents or incidents in accordance with state requirements;
                            - if the event is related to alleged abuse, notify the state agency in accordance with the “Abuse Prevention Program policy contained in the Operational Manual.” 

CMS Ex. 27 at 1.  According to the policy, the incident/accident report must include an exact description of location, time and date, level of consciousness, description of injury, description of any emergency care given, vital signs of residents, and any persons notified of the incident.  CMS Ex. 27 at 2. 

**Facility policy:  call light**.  A facility policy requires staff to respond to a resident’s request and needs.  Residents should have functioning call lights.  Staff must answer the call light “in a prompt, calm, and courteous manner.”  If a resident can’t use the call light, staff must monitor more frequently and attempt to anticipate the resident’s needs.  CMS Ex. 30. 

**C.  The Facility’s Repeated Failure to Prevent Accidents**.  The facility was not preventing accidents.  The facility’s fall log lists 55 falls from June through August 2020.  The falls involved 27 residents, 16 of whom suffered multiple falls (from two to six).  CMS Ex. 63.27 

**Resident 94 (R94)** (September 16 survey).  R94 was a 92-year-old woman, admitted to the facility on February 17, 2020, suffering from dementia and muscle weakness.  She had a history of stroke and a torn meniscus (knee cartilage).  Her gait and mobility were abnormal, and she had a history of repeated falls.  Her assessment placed her at high risk for falls.  CMS Ex. 12 at 59; CMS Ex. 59 at 1, 2, 14-15, 19, 28; CMS Ex. 124 at 6 (Knight Decl. ¶ 23). 

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Initially, R94’s care plan directed staff to:  assure that the floor is free of glare, liquid, and foreign objects; keep her bed in the lowest position, with the brakes locked; keep her call light in reach at all times; keep personal items and frequently used items within her reach; obtain a physical therapy consult, as needed; occupy the resident “with meaningful distractions”; orient the resident when there has been new furniture placement or other changes in environment; provide proper, well-maintained footwear; provide the resident with an environment free of clutter; and provide toileting assistance before and after meals and at night time, as needed.  CMS Ex. 59 at 65-67. 

Even assuming that the interventions were implemented (which is doubtful), they were ineffective.  Almost immediately, the resident fell: 

On **February 19, 2020**, she attempted to stand up from her wheelchair and slipped to the floor.  She was apparently uninjured.  CMS Ex. 59 at 62.  Contrary to facility policy, staff did not prepare a “complete, thorough, and accurate” incident report – or any incident report.  The summary of the event in the resident’s progress notes is minimal; it does not indicate that family or physician were notified, and no interventions are mentioned.  *See* CMS Ex. 27. 

On the same day, R94’s care plan added that staff should encourage the resident to wear appropriate footwear, including nonskid socks.  CMS Ex. 9 at 65.  The record does not indicate whether improper footwear had contributed to the resident’s fall.  In any event, this was not really a change since the plan had already called for proper footwear.  

Although she was at high risk for falls and had fallen once since she was admitted, the facility did not refer R94 to its Falls Prevention Program.  A February 24 Fall Risk Assessment indicates that no referrals were necessary.  CMS Ex. 59 at 26. 
                            - On  February 26, 2020 , R94 fell while in her room.  CMS Ex. 59 at 49, 61.  Although a progress note describes the fall as “witnessed” (CMS Ex. 59 at 49), a more complete note shows that it was not.  The LPN on duty reported that she was at the nurse’s station when she heard a “loud thump” followed by a resident yelling “Help.”  The resident had fallen completely back and “had a hard hit to the head.”  She suffered a hematoma on the back of her head and was bleeding.  She was screaming in pain.  CMS Ex. 59 at 61.  The facility sent her to the emergency room.  CMS Ex. 59 at 38, 61-62. 

On the same day, February 26, the facility amended R94’s care plan to add “frequent checks when resident in bed.”  CMS Ex. 59 at 65.  Again, staff did not prepare an accident report, and, notwithstanding her two falls and fairly serious injury, the facility did not refer R94 to its Falls Prevention Program.  Instead, her February 26 fall risk assessment again indicates that no referrals are necessary.  CMS Ex. 59 at 28. 

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                            - On  March 24, 2020 , a nurse aide found R94 on the floor of her room, near the bathroom door.  She hit her head on the wood trim in the doorway and was bleeding.  Again, the facility called the paramedics, and R94 was taken to the emergency room where she was treated for a head laceration.  CMS Ex. 59 at 38, 48, 60. 

On March 26, 2020, the facility amended the resident’s care plan to add that the resident should be moved closer to the nurses’ station.  CMS Ex. 59 at 65.  If this occurred, it is not documented in the resident’s progress notes.28 
                            - A progress note indicates that, at 11:30 p.m. on  June 7, 2020 , the resident was again found on the floor of her room.  She was next to her bed.  She had edema (swelling) and a contusion on her left upper forehead.  She complained of pain.  Once more, she was sent to the emergency room.  CMS Ex. 59 at 33, 38, 59.  A note entered by the nurse practitioner on June 8, 2020, at 8:29 p.m. indicates that R64 and her roommate “were helping each other transfer” when both fell to the floor.  CMS Ex. 59 at 45.  Staff prepared a fall report, which is the only fall report in the record.  CMS Ex. 59 at 33. 

A June 8 Fall Risk Assessment finally indicates that a referral to the Falls Prevention Program may be appropriate.  CMS Ex. 59 at 30.  Her care plan does not indicate that she was referred.  Instead, an entry in R94’s care plan, dated June 9, 2020, says “therapy to screen post fall.”  CMS Ex. 59 at 65. 

The referral – if it occurred – came too late.  R94’s condition declined.  A June 15, 2020 progress note describes a “lump and discoloration to left forehead and discoloration to the left jaw.”  CMS Ex. 59 at 58.  She continued to have a “large knot” on the left side of her head and complained of pain.  On June 19, staff finally reported her condition to the resident’s nurse practitioner, who directed them to send her back to the emergency room.  CMS Ex. 59 at 56.  The hospital confirmed that she had suffered a bilateral brain bleed.  CMS Ex. 12 at 61; CMS Ex. 59 at 39-40. 

R94 returned to the facility on hospice status and died within two weeks.  CMS Ex. 12 at 63; CMS Ex. 59 at 53.  

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For its part, Petitioner does not dispute (or even address) CMS’s allegations, which are well-supported by the evidence in the record.  Notwithstanding her high risk and her actual falls, the facility took minimal (if any) steps to reduce her foreseeable risks.  Instead, on multiple occasions, R94 was left alone and unsupervised, and she fell, ultimately suffering a life-threatening injury.  This put the facility out of substantial compliance with section 483.25(d). 

**Resident 74 (R74)** (October 29 survey).  R74 was a 64-year-old man, admitted to the facility on July 7, 2020.  He suffered from acute and chronic respiratory failure, chronic obstructive pulmonary disease, Type 2 diabetes, heart disease, chronic kidney disease, and many other disorders.  He had peripheral nerve damage and his legs had been amputated below the knee (which, strangely, his admission records didn’t mention).  CMS Ex. 99 at 1, 6. 

R74’s care plan identified the risk of falling as a problem for R74, and care plan entries, dated July 7, 2020, direct staff to (among other interventions) obtain a physical therapy consult for positioning and other factors, and to keep his bed in the lowest position, with the brakes locked.  CMS Ex. 99 at 12. 

Staff apparently did not keep R74’s bed in the lowest position.  On July 13, 2020, he was unattended in his room when he fell from his bed.  The nurse reported that she “heard a noise.”  She entered the resident’s room and found him sitting on the floor beside his bed.  R74 reported that his bottom half had been too close to the edge of the bed, and he slid off.  CMS Ex. 99 at 7.  The incident report indicates that the resident and staff were educated to keep his bed in the lowest position.  A mat was placed on the floor beside the bed.  CMS Ex. 99 at 7. 

A care plan entry, dated July 13, calls for a scoop mattress on R74’s bed.  CMS Ex. 99 at 12.  Additional entries, dated July 17, 2020, direct staff to instruct the resident in “proper bed mobility techniques using repositioning bars to promote independence.”  Staff were instructed to maintain the resident’s body “in functional alignment when at rest” and not to allow him to lie too close to the repositioning bars.  Again, an entry directs that his bed be in the lowest position.  Staff were to provide him with repositioning, as needed, and to turn and reposition him frequently.  CMS Ex. 99 at 10-11. 

On October 19, 2020, R74 told Surveyor April Murphy that he had fallen the day before.  He said that staff dropped him, and he slid “hard on to the ground,” and had hurt his leg stumps and his rectum.  CMS Ex. 129 at 2 (Murphy Decl. ¶ 9).  Surveyor Murphy interviewed staff about the incident, who confirmed that an incident occurred but claimed that it was a “controlled transition” to the floor.  Staff were attempting to transfer the resident, using a “slide board,” a flat device used to transfer and move residents across a surface.  CMS Ex. 129 at 2 (Murphy Dec. ¶ 9).  Staff did not document the incident. 

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Failing to document this incident violated the regulation and the facility’s policy.  The resident went from the bed to the floor and complained of pain as a result of his hitting the floor.  By any definition, this was a fall.  A double amputee is simply not supposed to end up on the floor when staff are moving him.  That the resident fell shows that staff were not transferring him properly.  Moreover, even if this weren’t a fall, it was definitely an incident.  Whenever a resident involuntarily ends up on the floor, that must be considered an accident, and under section 483.25(d) and the facility’s policy, it must be investigated and reported.  Staff are not free to ignore it, and their doing so also put the facility out of substantial compliance with section 483.25(d).  *See* CMS Ex. 27 at 1; *Dumas Nursing and Rehab.,* DAB No. 2347 at 15 (2010) (finding that a facility’s failure to investigate properly means that it could not identify, understand, and correct its deficient practices); *Beechwood Sanitarium*, DAB No. 1906 at 106-107 (2004) (affirming a finding of noncompliance with (then) section 483.25(h)(2) based on the facility’s failure to investigate).  

These are not the only examples of the facility’s failing to prevent accidents.  As I discuss below, R87 fell from his bed, and R9 fell twice, ultimately fracturing her hip.  The facility did not have adequate staff to provide her with the supervision and assistance she needed to avoid accidents, yet another example of its substantial noncompliance with section 483.25(d) (as well as section 483.35). 

Because the facility did not ensure that its residents received adequate supervision to prevent accidents, it was not in substantial compliance with section 483.25(d). 
                            *The facility was not in substantial compliance with 42 C.F.R. § 483.35 because it did not have adequate nursing staff to provide the services necessary to assure the highest practicable physical, mental, and psychosocial well-being of each resident.  *

**Program requirement:  42 C.F.R. § 483.35(a)(1)(2) (Tag F725)**.  The facility must have sufficient nursing staff with appropriate competencies and skill sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity, and diagnoses of the facility’s resident population and in accordance with the facility-wide assessment.29  To this end, it must provide services by sufficient numbers of

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licensed nurses and other nursing personnel, including, but not limited to, nurse aides, on a 24-hour basis to provide nursing care to all residents in accordance with resident care plans. 

The facility must designate a licensed nurse to serve as a charge nurse on each tour of duty. 

Federal staffing requirements for long-term-care facilities are thus tied to the needs of the residents.  *Westgate Healthcare Ctr.*, DAB No. 1821 at 11 (2002).  If a facility’s staffing levels are inadequate for providing the care and services necessary to keep residents safe, it is not in substantial compliance with the regulation.  *Golden Living – Mountain View*, DAB No. 2953 (2019); *Nightingale Home Healthcare, Inc.*, DAB No. 2784 at 24-25 (2017). 

From the examples of the facility failing to provide its residents with necessary care and services described above, one could reasonably infer that the facility lacked adequate staff.  It is therefore not surprising that facility staff, residents, the family members of residents, and the local ombudsman repeatedly complained that the facility did not have adequate staff to provide basic care, including helping residents to the bathroom, providing daily grooming, and answering call lights.  The September 16 statement of deficiencies details their complaints – which Petitioner has not refuted.  CMS Ex. 12 at 68-80.  Petitioner presents no employee testimony denying that staff made the statements attributed to them and no testimony denying that the statements are true.  *See Beatrice State*, DAB No. 2311 at 17, 18; *Omni Manor*, DAB No. 1920 at 11. 

Surveyor Barbara Vineyard, R.N., is an experienced nurse, who has been surveying facilities for the state agency since 2014.  She offered this alarming testimony: 

I have conducted hundreds of surveys since joining [the state agency].  However, I have never been on a survey prior to the September survey at Generations where so many complaints were substantiated at once.  Our survey team also faced unprecedented resistance from facility administration, who dodged interviews with us and withheld documents we requested.  The regulatory violations we observed were all intertwined with one theme – *the facility was severely understaffed, which led to many issues we uncovered during the survey*.  

CMS Ex. 125 at 3 (Vineyard Decl. ¶ 10) (emphasis added).30  *See* CMS Ex. 68 (facility time sheets). 

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Surveyor Vineyard interviewed staff, who told her that there were too few people on duty to provide basic care to facility residents on most days.  Management was aware of the problem but ignored their concerns.  Specifically:  
                            - They complained that they did not have enough staff to assist residents with activities of daily living (“no way”);
                            - They reported that inadequate staffing resulted in an increase in falls;
                            - They explained that oxygen,  slings , and other equipment were stored in the basement; staff could not both care for the residents  and  retrieve the equipment, because there were not enough of them; 31
                            - Staff described themselves as “burned out” because they worked extra shifts and went without breaks;
                            - Staff were forced to “pick and choose” which residents’ vital signs and respiratory status to monitor. 

CMS Ex. 12 at 76-79; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 17).  Surveyor Vineyard quoted staff: 
                            - “We do our best to pass meal trays and answer call lights, but most of the time it is impossible . . . someone is going to get hurt if we continue to work like this”;
                            - “When we are all in with a resident, we do not have anyone else to answer call lights, but most of the time, it is impossible . . . and when we come out of the room (after providing resident care), sometimes all of the call lights are lit up on the board”;
                            - “People are not getting the care they need because there [are] not enough staff.” 

CMS Ex. 12 at 76-79; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 18). 

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Others confirmed the staff’s accounts.  The local ombudsman told Surveyor Vineyard that residents consistently called and complained that they were not getting the care they needed, that call lights went unanswered, and there were not enough staff to help them.  CMS Ex. 12 at 79; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 18).  

Residents and their families complained as well.  R1 (see discussion above) told the surveyors (on August 28 at 4:29 p.m.):  “I would put my call light on[,] and it would take them 45 minutes to an hour to come.  I would have accidents with my stool[,] and then they would be mad at me.  I know when I need to go but had to wait too long.  They would also say be right back and never come back.  There was never enough staff there.”  CMS Ex. 12 at 76.  

At Resident Council meetings, held May 27, 2020, and June 24, 2020, residents asked that call lights be answered more quickly and indicated there were not enough nurse aides or housekeepers.  They complained that they ran out of linens, and laundry was not returned quickly enough (or sometimes at all).  They asked for more cleaning staff, maintenance help, and better food on weekends.  CMS Ex. 70 at 1, 3. 

CMS offers some additional specific examples of how inadequate staffing at the facility affected resident care and safety:  

**Resident 9 (R9)** (September 16 survey).  R9 was a 94-year-old woman, admitted to the facility on June 1, 2020, with a long list of impairments, including a partial intestinal obstruction, hypertension, dementia, and obesity.  CMS Ex. 48 at 2, 11.  She had balance problems while standing and while walking and was unable to ambulate without assistance.  She required assistance to and from the bathroom.  CMS Ex. 48 at 6.  She was at high risk for falls related to her dementia with a behavioral disturbance, and difficulty walking.  CMS Ex. 48 at 7, 19.  Among other interventions, aimed at keeping her safe, nursing staff were to remind the resident not to ambulate or transfer without assistance, to keep her call light within reach at all times, and to provide her with a clutter-free environment.  CMS Ex. 48 at 19-20. 

On July 3, 2020, while unsupervised, R9 fell.  Staff observed her on the floor in her bedroom doorway.  According to the fall report, she told staff that she was trying to walk home.  She suffered blue discoloration, a laceration, and a bump on her left forehead.  CMS Ex. 48 at 3.  According to the fall report, she was standing at the time of the fall.  The “root cause” was identified as her confusion level.  *Id*. 

Staff added, as a fall intervention to R9’s care plan, “increase rounding.”  CMS Ex. 48 at 4.  An assessment completed the same day indicates that she would be referred to physical therapy and occupational therapy, and 15-minute checks were implemented, but, contrary to regulatory requirements, these interventions were not incorporated into the

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resident’s care plan.  CMS Ex. 48 at 7; *see* 42 C.F.R. § 483.21(b) (requiring care plans to meet the needs identified in the resident’s assessment). 

And there are two major problems with the “intervention” that was added to the resident’s care plan:  1) “increase rounding” is not a specific enough instruction to provide staff with “meaningful guidance” to respond effectively and consistently (*see**Sheridan*, DAB No. 2178 at 37); and 2) no evidence suggests that the intervention was implemented.  The facility was unable to produce any documentation of “increased rounding” or 15-minute checks for R9.  CMS Ex. 12 at 71.  In fact, the evidence shows that the facility did not have sufficient staff to check the resident regularly, and R9 suffered an additional and more serious fall. 

R9 suffered that fall on August 26, 2020.  According to the resident’s progress note, the nurse “heard a loud bang and went to check it out.”  She found the resident sitting in her room on top of a broken tray table.  The resident’s roommate witnessed the fall.  She told the nurse that R9 had been leaning on the tray table.  It broke, and the resident went down to the ground with it.  As she was being moved back to her bed, R9 complained of leg and knee pain.  She was sent to the emergency room and diagnosed with a right hip fracture and a brain bleed.  CMS Ex. 48 at 14.  Following hip surgery, she returned to the facility.  CMS Ex. 48 at 12, 14.  

The record includes two reports of the August 26 incident:  the facility’s internal report and the report it submitted to the state agency on September 3, 2020.  CMS Ex. 48 at 8-10, 11-12.  The internal report inaccurately indicates that an ambulance was not called.  CMS Ex. 48 at 8.  In fact, an ambulance was called and took the resident to the hospital.  CMS Ex. 48 at 14.  Both reports inaccurately indicate that the fall was unwitnessed.  CMS Ex. 48 at 8, 11.  In fact, the fall was witnessed by the resident’s roommate.  CMS Ex. 48 at 14.32 

The reports also say that the resident’s call light was “not activated.”  The witnesses to the incident said otherwise.  On August 27, 2020, a registered nurse (identified as V7) told Surveyor Vineyard: 

There were 42 people on this floor (4th floor).  They only had one nurse and one [nurse aide] last night (8/26/20); we had a resident fall [R9], and we sent her to the hospital.  *Her call light was on, but no one answered it*.  We have multiple residents that require at least two [person assist], and we do not have the staff for them.  We’ve had more falls because we don’t have enough staff to answer call lights and take care of residents like we need to.  The Alzheimer’s unit is up here too (4th floor).  We can’t do everything

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with one nurse and one [nurse aide].  Call lights will go off for hours.  Just not enough staff to give the care. 

CMS Ex. 12 at 72; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 15) (emphasis added). 

R9’s cognitively-intact roommate (R43) confirmed that R9’s call light was on.  She told Surveyor Vineyard that R9 needed to go to the bathroom[,] so R43 put the call light on for her.  While waiting for a response, R9 leaned against her table, fell, and broke her hip.  “They take a long time to answer call lights here because there is not enough of them.  No one had been around here for quite a while, at least a half hour or so.  There is never enough staff here, and you never see anybody to help you.”  CMS Ex. 12 at 72; CMS Ex. 125 at 3-4 (Vineyard Decl. ¶ 15). 

The LPN, who was responsible for R9 on the night of August 26, told the surveyor that only one nurse and two nurse aides were working on the fourth floor that night.  One nurse aide had to remain in the secure unit at all times.  So just one nurse aide was available to answer call lights on R9’s unit.  The LPN herself was too busy passing medications and performing other nursing duties to attend to the residents’ activities of daily living needs.  CMS Ex. 12 at 72-73; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 15). 

**Resident 87 (R87)** (September survey).  R87 was a 66-year-old man, initially admitted to the facility on December 1, 2018.  He suffered from a long list of impairments, including chronic obstructive pulmonary disease, hypothyroidism, congestive heart failure, chronic respiratory failure with hypoxia, and stage 4 chronic kidney disease.  He was morbidly obese.  At six feet tall, he weighed 433 pounds.  CMS Ex. 58 at 1, 2, 46.  He was cognitively intact but suffered from depression.  CMS Ex. 58 at 21, 41.  According to his August 14, 2020 assessment, he did not reject evaluation or care.  CMS Ex. 58 at 25. 

At 5:10 a.m. on August 22, 2020, R87 was found lying on the floor; he reported that he “rolled out of bed.”  CMS Ex. 58 at 10, 69.  According to the facility’s internal report, “four staff were in assistance” prior to the fall.  CMS Ex. 58 at 11.  This seems misleading, if not out-and-out false; no staff were near him when he fell.  Just one nurse responded when he called for help.  She left him and asked a second nurse to assist.  No other staff are named in the reports or progress notes.  CMS Ex. 58 at 13-14, 69.  

According to a late-entry progress note, entered at 12:19 p.m. on August 23, the resident would not allow the nurse to assess him.  Staff *were not able to get the resident off the floor*.  The nurse notified the Fire Department, which came to assist.  CMS Ex. 58 at 69.  The facility sent a report to the state agency on August 31, 2020, stating that R87

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complained that a facility staff member (the nurse) was “unprofessional and ‘rude.’”  CMS Ex. 58 at 13.  The report includes no details of his allegation.33

The surveyor interviewed the resident and his roommate, who offered more detailed accounts.  On September 1, 2020, R87 stated: 

On [August 22] I rolled out of bed onto the floor at 4:50 a.m. and [lay] there until the day shift came in.  I yelled for help and my roommate (R70) turned on the call light for help.  Twenty minutes later, [the LPN on duty] came to my door.  The fire department came at 6:45 am and helped the day shift get me off the floor at 7:00 am.  I was on the floor for over two hours because there was not enough staff to get me off the floor.  The weekends and night shift are the worst.  They have one [nurse aide] and one nurse working.  It takes forever for them to answer our light.  I rarely see any staff. 

CMS Ex. 12 at 74; *see* CMS Ex. 125 at 4 (Vineyard Decl. ¶ 16). 

R70 confirmed R87’s account.  He was interviewed at 11:00 a.m. on September 4, 2020, and reported: 

I pulled the call light on [August 22] when [R87] fell.  No one came to help us, so I called 911.  He [lay] on the floor for two hours before they got him off the floor.  The weekends and nights are the worst when they have one nurse and one [nurse aide] for the whole building for both floors.  I have had to wait an hour and a half for someone to come help me before. 

CMS Ex. 12 at 74; *see* CMS Ex. 125 at 4 (Vineyard Decl. ¶ 16). 

In an August 27, 2020 interview, the RN identified as V7 confirmed that, when R87 fell on August 22, only one nurse and one nurse aide were on duty in the unit.  The resident was left on the floor until after the day shift came in.  CMS Ex. 12 at 74. 

The LPN who had been on duty that night confirmed that:  

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We generally only have one nurse and one [nurse aide] on each floor during the night.  The night R87 fell, I had only one [certified nurse aide] on the floor with me.  There was a [Temporary Nursing Aide] working with [the LPN] on the third floor.  I have talked to [the DON] numerous times and told her I do not feel comfortable with so little staff.  That night *we could not leave the floor to go to the basement laundry area to retrieve the proper fitting mechanical lift sling for R87 due to not enough staff* to cover the floor.  We had to wait until day shift came and the Fire Department to get R87 off the floor. 

CMS Ex. 12 at 102-103 (emphasis added). 

The surveyor reviewed the time sheets for the midnight shift on August 21-22, 2020.  For the entire facility (83 residents, 16 of them needing skilled care), two nurses and two nurse aides (one certified, one not certified) were scheduled to work from 10:30 p.m. to 7:00 a.m.  CMS Ex. 12 at 74-75; CMS Ex. 68 at 7; CMS Ex. 125 at 4 (Vineyard Decl. ¶ 16). 

The facility offers two responses to R87’s situation.  First, it again blames the resident, claiming that he would not allow the nurse to assess him, and he could not be moved without first being assessed.  P. Br. at 13; *see* CMS Ex. 58 at 69; P. Ex. 6 at 1.  This is not consistent with statements from R87 and his roommate. 

But, even if true, Petitioner’s subsequent admission renders the claim irrelevant.  Petitioner concedes that *the facility did not have the equipment or staff needed to return the resident to his bed*.  P. Br. at 13.  Even when the day shift arrived, the facility did not have sufficient staff or equipment to move the resident, and it had to call in the Fire Department.  The EMTs were able to make the transfer expeditiously; they arrived at 6:43 a.m. and the task was completed by 7:05 a.m. (which begs the question:  why did the facility wait so long before it called them?)  P. Ex. 6 at 7.  The Fire Department had the necessary staff and equipment to perform the task, which, because it accepted morbidly obese residents, the facility should have had, but did not.  P. Ex. 6 at 5. 

The parties quibble about the exact length of time, R87 had to stay on the floor.  The EMT records, which I consider reliable, show that he was returned to his bed at 7:05 a.m.  P. Ex. 6 at 7.  According to the resident, and corroborated by his roommate, he fell to the floor at 4:50 a.m.  CMS Ex. 125 at 4 (Vineyard Decl. ¶ 16).  If accurate, R87 was left on the floor for over two hours.  The LPN who responded indicated that he fell at 5:10 a.m.; this was when she found him on the floor, and it assumes that she responded immediately to his call for help or to R70’s call light.  CMS Ex. 58 at 10.  If accurate, he was left on the floor for just under two hours.  Either amount of time is wholly unacceptable.  It establishes that the facility was not adequately staffed to provide a basic service to a one

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of its residents because of his size (and, as the evidence establishes, he was not the facility’s only morbidly obese resident who was denied basic services because the facility lacked appropriate staff and equipment to meet the resident’s needs).  

**The facility’s failure to correct**(October 29 survey).  Once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again, as determined by CMS, based on a revisit survey or “after an examination of credible written evidence” that CMS can verify without an onsite visit.  42 C.F.R. § 488.454(a)(1); *Ridgecrest Healthcare Ctr.,*DAB No. 2493 at 2-3 (2013); *Taos Living Ctr.,* DAB No. 2293 at 20 (2009); *Premier Living & Rehab Ctr.*, DAB No. 2146 at 3 (2008); *Lake City Extended Care,* DAB No. 1658 at 12-15 (1998).  The *burden is on the facility* to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist.  *Asbury Care Ctr. at Johnson City,* DAB No. 1815 at 19-20 (2002). 

The facility must show that the incidents of noncompliance have ceased *and* that it has implemented appropriate measures to ensure that similar incidents will not recur.  *Libertywood Nursing Ctr.,* DAB No. 2433 at 15 (2011) (citing*Life Care Ctr. of Elizabethton*, DAB No. 2356 at 16 (2011); *accord*, 42 C.F.R. § 488.454(a) and (e); *Hermina Traeye Memorial Nursing Home,* DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation “acceptable to CMS” showing that it was in substantial compliance and was capable of remaining in substantial compliance on the earlier date); *Cross Creek Care Center,* DAB No. 1665 (1998)). 

Petitioner has not established that it achieved substantial compliance by the time of the October 29 survey.  Initially, the facility’s administrator refused to give Surveyor Vineyard the facility’s staffing documents, insisting that the facility exceeded regulatory mandates.  When she finally provided the records, she would not answer the surveyor’s questions about the facility’s response when scheduled staff do not come in and the facility’s scheduler cannot find a replacement.  She would not tell the surveyor if she were notified of any employee “no-calls, no-shows, or late arrivals.”  CMS Ex. 125 at 3 (Vineyard Decl. ¶ 12). 

In fact, the evidence establishes that the facility’s staffing situation did not appreciably improve following the September survey.  The facility continued to lack sufficient staff to meet the basic needs of its residents. 

As required by regulation, the facility assessed what resources it needed to care for its residents competently.  CMS Ex. 82 at 8; *see* 42 C.F.R. § 483.70(e).  According to that assessment and its staffing plan, the facility required:  *one nurse practitioner, 17 licensed nurses, and 37 certified nurse assistants providing direct care* to meet the acuity needs of its residents, (activities of daily living needs, nursing needs, skin and medical care,

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psychological needs, and “other special considerations to provide person-centered care).34  These numbers are in addition to the three RNs and two LPNs who performed administrative duties, a social services director and Alzheimer’s unit director, a registered dietician, a food service director, and 15 dietary staff, a licensed nurse and two certified technicians for the dialysis unit, and an activities director with two assistants.  CMS Ex. 15 at 18; CMS Ex. 82 at 8; CMS Ex. 128 at 2 (Roos Decl. ¶ 11). 

The facility’s daily assignment sheets showed that the facility consistently and deliberately failed to meet its own staffing requirements by significant numbers: 
                            - On October 14, 2020, five licensed nurses and nine nurse aides worked the first shift; four licensed nurses and nine nurse aides worked the second shift; and three licensed nurses and four nurse aides worked the third shift (for a total of 12 licensed nurses and 22 nurse aides for the day).  CMS Ex. 15 at 19; CMS Ex. 104 at 1; CMS Ex. 128 at 2 (Roos Decl. ¶ 11). 
                            - On October 17, 2020, five licensed nurses and eight nurse aides worked the first shift; four licensed nurses and nine nurse aides worked the second shift; and two licensed nurses and six nurse aides worked the third shift (for a total of 11 licensed nurses and 23 nurse aides for the day).  CMS Ex. 15 at 19; CMS Ex. 104 at 2; CMS Ex. 128 at 2 (Roos ¶ 11). 

According to the facility’s daily staffing post, on October 26, 2020, only three nurses were working the day shift.  CMS Ex. 15 at 19; CMS Ex. 128 at 2 (Roos Decl. ¶ 11). 

The facility’s scheduler (also a nurse aide) confirmed that she scheduled “a minimum of four nurses and nine nurse aides for the first and second shifts; she scheduled three nurses and six nurse aides for the third shift (for a total of 11 nurses and 24 nurse aides per day)”.  She told Surveyor Jennifer Roos, R.N., that she was unaware of the facility’s assessment and staffing plan.  To determine how many staff to schedule, she followed instructions from the facility’s administrator.  CMS Ex. 15 at 20; CMS Ex. 128 at 3 (Roos Decl. ¶ 14). 

The facility’s administrator confirmed the minimum number of staff scheduled per day as four nurses and six nurse aides for the first shift, four nurses and five nurse aides for the second shift, and three nurses and three nurse aides for the third shift (for a total of 11 nurses and 14 nurse aides per day).  CMS Ex. 15 at 20; *see* CMS Ex. 128 at 3 (Roos Decl.

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¶ 14) (quoting the administrator as confirming a daily minimum total of 11 nurses and 18 nurse aides).  So, it seems that, as a matter of practice, the facility deliberately scheduled far fewer than the number of staff the facility’s own assessment determined essential to meet the acuity needs of its residents. 

The 400 hall (fourth floor) was especially affected by the scarcity of staff.  Forty-seven residents resided there, and it included the secure unit.  CMS Ex. 15 at 19; CMS Ex. 101 at 2.  Staff reported that, frequently, only one nurse worked the entire floor during the day.  And, on October 26, just one LPN was working on the entire floor for the day shift.  At 11:45 a.m. that morning, she told Surveyor Roos that she was still completing the morning medications pass, which began at 8:00 a.m.  She still had 12 more residents to see before she finished.  CMS Ex. 15 at 20; CMS Ex. 128 at 3 (Roos Decl. ¶ 12). 

Petitioner does not respond directly to most of the evidence of staff and resident complaints, although it attacks one of the (many) residents who complained to the surveyors about insufficient staffing.  Petitioner identifies the resident as R39 (from the October 29 annual survey) and R20 (from the follow-up December 9) survey.  He’s an odd resident to focus on.  Although his name appears on the attendance sheet of one Resident Council meeting (CMS Ex. 69 at 3), CMS does not specifically mention his complaints in any of its arguments.  Nevertheless, Petitioner describes the resident as “manipulative” and asserts that “[e]ven when staff respond to the resident, he will then refuse the care offered.”  P. Br. at 18.  Based on the resident’s care plan, Petitioner either overstates the resident’s propensity to refuse care or the care plan understates it.  It indicates that the resident resists care “at times.”  P. Ex. 7 at 12, 13.  In any event, I reject Petitioner’s implication that the resident is entitled to less staff attention because he refuses care.  If anything, the instructions contained in the resident’s care plan suggest that staff should spend as much, if not more time (and patience), with the resident, actively involving him with his care, avoiding power struggles, explaining the disease process and consequences of his refusal, and praising him when his behavior is appropriate.  P. Ex. 7 at 13.35 

Petitioner has not produced a single facility employee who claims that the facility was adequately staffed.  It nevertheless argues – without offering testimony or other evidence in support – that CMS has misinterpreted the staffing chart included in the facility’s assessment.  It distinguishes between the number of staff the facility needed on a daily basis and “the number of full-time equivalents the facility needs to staff appropriately based on resident need.”  P. Br. at 15, 18; *see* CMS Ex. 25 at 8.  I have no idea what this distinction means, and Petitioner has not explained it.  Nor has Petitioner explained why it was not required to provide the “full-time equivalent” number of staff called for in the

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assessment.  If anything, “full-time equivalent” suggests some part-time employees, which would result in more, not fewer, assigned staff. 

According to Petitioner, the facility’s software system for scheduling is based on state minimum staffing levels, and its staffing numbers are consistent with those state requirements.  P. Br. at 17.  Petitioner’s explanation of the numbers is hardly a model of clarity, but I assume that Petitioner is referring to the state’s administrative code, which requires facilities to allot a minimum of 3.8 hours of nursing and personal care per day per resident needing skilled care and 2.5 hours per resident per day for residents needing intermediate care.  77 IL Admin. Code § 300 (8-30).  These numbers, however, do not consider the individual needs of a facility’s residents.  Petitioner acknowledges as much, conceding that “even when staffing numbers are met, the needs of the clients are not.”  P. Br. at 18. 

Petitioner thus effectively concedes that it was not in substantial compliance with federal staffing requirements.  As the Board long ago explained, meeting a state standard does not establish that the federal standard is met because the federal standard uses a different measure – the needs of the particular residents who are in the facility.  The facility must set its staffing levels based on its own evaluation of the resident’s needs.  *Westgate*, DAB No. 1821 at 11-12; *see**Golden Living – Mountain View*, DAB No. 2953 at 8-14 (finding that the facility was not in substantial compliance with the staffing regulation because it did not consider adjusting staffing levels to increase the care and supervision of residents who were experiencing an increase in the number of falls); *Windsor House*, DAB No. 1942 at 30-32 (2004) (finding that the facility’s failing to provide sufficient staff to assist residents who required feeding assistance put the facility out of substantial compliance with federal staffing requirements).  

The facility was therefore not in substantial compliance with section 483.35 because it did not have adequate staff to meet the needs of its residents.  Following the September survey, CMS provided ample notice that the facility’s staffing levels were inadequate.  Yet, the facility made no apparent efforts to correct its staffing problems, which continued. 
                            The facility was not in substantial compliance with 42 C.F.R. § 483.80, because, contrary to facility policies and CDC (Center for Disease Control and Prevention) guidelines, staff ignored isolation precautions and did not follow safe hand hygiene practices.

**A.  Program requirements:**  **Section 1819(d)(3)** of the Social Security Act mandates that a skilled nursing facility must (A) establish and maintain an infection control program to provide a “safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection,”

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and (B) be designed, constructed, equipped, and maintained in a manner that protects the health and safety of residents, personnel, and the general public. 

Consistent with section 1819(d)(3), **42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880)** requires the facility to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections. 

The program must include: 
                            - 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; 36
                            - written standards, policies, and procedures for the program, which must include: 	                               - a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
                              - when and to whom possible incidents of communicable disease or other infections should be reported;
                              - standard and transmission-based precautions to be followed  to prevent spread of infections;
                              - when and how isolation should be used for a resident, including: 		                                 - the type and duration of the isolation, depending upon the infectious agent or organism involved: and
                                - a requirement that the isolation should be the least restrictive possible for the resident under the circumstances. 
                              - 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

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                            - the hand hygiene procedures to be followed by staff involved in direct resident contact . 

*  *  *  *  *
                            - a system for recording incidents identified under the infection prevention and control program and the corrective actions to be taken by the facility. 

Personnel must *handle, store, process, and transport linens so as to prevent the spread of infection*. 

The facility must also conduct an annual review of its infection prevention and control program and update the program, as necessary. 

The infection-control regulation thus requires that the facility have written policies in place, and that it *implement* those policies.  If it does not, it violates section 483.80(a).  *Golden Living Ctr. – Superior*, DAB No. 2768 at 7 (2017); *Heritage House of Marshall Health & Rehab. Ctr*., DAB No. 2566 at 13 (2014).37 

**B.  Facility policies:  infection control**.  The facility had in place an infection control policy describing its written program for “implementing systems that provide a safe, sanitary, and comfortable environment” and helping prevent communicable diseases and infections from developing and being transmitted.  The program includes a long list of components, including: 
                            - A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for residents, staff, visitors, and other individuals “providing services based upon the facility’s assessment in conjunction with hazards and vulnerability analysis that is consistent with national standards.” 
                            - A system for surveillance, reporting of communicable diseases or infections, standards and transmission-based on precautions and isolation procedures. 
                            - A system for recording incidents identified under the facility’s Infection Prevention and Control practices. 
                            - The facility maintains protocols and precautions to prevent transmission of infectious agents, using two tiers of precautions:  a) s tandard precautions ; and b)  transmission-based precautions  (contact precautions; droplet precautions;

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combination of precautions.  The “[f]acility does not have the capacity to maintain airborne precautions).” 
                            - The facility provides personal protective equipment (PPE), which refers to barriers used alone or in combination to protect mucous membranes, airways, skin, and clothing from contact with infectious agents.  PPE use is “based upon the nature of the interaction with the resident and/or the likely mode of transmission.”  When the supply of PPE is not sufficient, the facility will follow CDC guidance for optimizing PPE.  Types of PPE include:  gloves, gowns, masks, and eye protection (goggles, face shields). 
                            - Hand hygiene  is used to reduce the spread of germs to residents and the risk of the health care provider’s “colonization of infection by germs acquired from a resident.”  The facility uses handwashing and alcohol-based hand sanitizers. 
                            - Standards of practice related to respiratory hygiene/cough etiquette. 
                            - Systems for determining room assignments for those with infectious disease/cohorting. 38  
                            - Systems for monitoring resident care areas, such as urinary catheters, incontinence, wound care, skin care, infusion therapy, dialysis, mechanical ventilation, and associated risks. 
                            - Medication testing and Point-of-Care testing, e.g., blood glucose monitoring. 
                            - Procedures for environmental cleaning with appropriate disinfecting chemicals and for disinfecting resident care equipment. 
                            - Occupational health policies to include staff to remain home when ill. 
                            - Systems for continuity of care and communication during transfer of residents to other levels of care. 
                            - Systems for notifying families of changes in condition and any other notifications required by a regulatory agency. 

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                            - Procedures for managing outbreaks of infection and pandemics,  following guidance provided by the local health department, state regulatory and/or communicable disease division, and the CDC . 
                            - Report communicable diseases and outbreaks, as required to the local health department and state agency in the manner prescribed. 
                            - Policies and procedures that address storage and handling of linen . 
                            - The facility identifies common infections in long term care and uses McGreer’s Definitions for Healthcare Associated Infections for Long Term Care Facilities.  The facility implements testing of such infections based on symptom reporting to the physician/physician extender and will implement testing as ordered. 
                            - A program of immunizations for residents, which includes:  pneumonia and influenza immunization programs. 
                            - A program of screening for Tuberculosis for both residents and staff. 
                            - The facility will develop plans and/or required testing for any outbreak, epidemic, or pandemic, as required by a regulatory agency. 
                            - The facility will work with the local health department and the state agency to obtain testing materials during outbreaks, epidemics, and pandemics.  The facility also engages the services of a laboratory for assistance and testing, as needed.  If the facility obtains the tests themselves, all specimens/requisitions will be labeled appropriately with resident identifying information. 
                            - The facility will report to the local health department or the state agency the number of residents and staff tested, the number of positive, negative, and indeterminate cases, as directed by the local health department or state agency. 
                            - The facility appoints an Infection Preventionist, who is responsible for coordinating the infection control program.  The Infection Preventionist advocates for each resident to monitor and ensure that the standards of practice to prevent and control infections are followed.  The Infection Preventionist reviews the facility’s infection control program annually, or more frequently, as required, and provides information regarding recommendations for policy changes as needed, based on regulatory requirements and recognized standards of practice. 
                            - The facility maintains an Antimicrobial Stewardship Program. 

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                            - The facility  maintains an ongoing program of staff education that includes:  hand hygiene, standard and transmission-based precautions, proper use of PPE , and monitoring for infections, noting signs and symptoms. 
                            - The facility maintains a surveillance program, systematically collecting health-related data.  The program’s purpose is:  a) to identify early warnings of potential patterns, trends, or facility outbreaks; b) monitor the facility’s infection control program for strengths or weaknesses in various departments (e.g.,  hand hygiene , dietary processes, housekeeping cleaning procedures, laundry processes and  handling linen , antibiotic usage, etc.); c) routine analysis, identifying issues and activities to control infections, which will be presented to the facility’s Quality Assurance and Quality Improvement and Infection Control committees for action. 

CMS Ex. 87. 

**Facility policy:  isolation precautions**.  The stated objective of the facility’s isolation policy is to follow and implement isolation precautions according to CDC recommendations.  It divides the types of precautions into two categories:  standard precautions and transmission-based precautions (airborne precautions, droplet precautions, contact precautions). 

**Standard Precautions**.  The policy explains that standard precautions are “designed to reduce the risk of transmission of blood borne pathogens and those from moist body substances.”  *The precautions apply to all residents*, regardless of diagnosis or infection status.  Standard Precautions apply to:  a) blood; b) all body fluids, secretions, and excretions, except sweat, regardless of whether they contain visible blood; c) nonintact skin; and d) mucous membranes.  The purpose of standard precautions is to decrease the risk of transmission of microorganisms from both recognized and unrecognized sources of infection.  They are used in the care of all residents, and include the following: 
                            - Hand Hygiene :   hands must be washed, using soap and water, after touching blood, body fluids, secretions, excretions, and contaminated items, whether or not gloves are worn.  Hand hygiene must be performed immediately after removing and disposing of PPE, between resident contact, and when otherwise indicated to prevent contamination . 
                            - Gloves :  (clean, nonsterile gloves are adequate) must be worn when touching blood, body fluids, secretions, excretions, and contaminated items, such as visibly or potentially contaminated resident care equipment and environmental surfaces.  Gloves should be put on prior to tasks that require touching mucous membranes, and nonintact skin.   Gloves must be changed between tasks and procedures on the same resident .  Gloves must be removed promptly after use and before touching

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noncontaminated items and environmental surfaces and before going to another resident.  *After gloves are removed, hand hygiene must be performed*. 
                            - Masks, Eye Protection, Face Shield :  are to be worn during procedures that may generate splashes or sprays of blood, secretions, or excretions. 
                            - Gown :  (nonsterile is adequate) must be worn during procedures that are likely to generate splashed or sprays of blood, secretions, or excretions on to clothing.   A soiled gown is removed as promptly as possible, and hand hygiene performed to prevent transfer of microorganisms . 
                            - Resident Care Equipment:   all contaminated equipment is to be handled in a manner that prevents skin and mucous membrane contaminations.  Dispose of single use equipment promptly; properly clean and disinfect reusable equipment before use by another resident. 
                            - Environmental Control :  use routine procedures for cleaning and disinfecting environmental surfaces, including beds, siderails, positioning assistants (e.g., halos, trapezes), bedside equipment, and other frequently touched equipment and surfaces. 
                            - Linen :   handle and transport any linen contaminated with blood, body fluids, or secretions in a manner that prevents skin and mucous membrane exposures and contamination of clothing . 
                            - Occupational Health and Bloodborne Pathogens :    	Sharps:  do not reuse needles and take care to prevent injuries when using needles, scalpels, and other sharps.  Use proper punctuation-resistant containers for disposal of all sharps.  Do not recap needles or use one-handed recapping method.	 Use mouthpiece, resuscitation bags, other ventilation devices or an alternative to mouth-to-mouth resuscitation.  
                            - Resident Placement :  it may be necessary to place any resident who contaminates the environment in a private room if the resident cannot assist in maintaining appropriate personal hygiene. 

**Transmission-Based Precautions**.  The policy also explains that transmission-based precautions are designed for residents who have documented or suspected infections with highly transmissible pathogens, for which additional precautions (beyond standard) are needed to prevent transmission.  There are three types of transmission-based precautions:

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airborne precautions; droplet precautions; and contact precautions.  They may be combined for diseases that have multiple routes of transmission and are always used *in addition to standard precautions*. 
                            - Airborne Precautions  are designed to reduce the risk of airborne transmission of infectious agents.  Because the facility cannot provide airborne precautions for residents with tuberculosis or measles, those residents will be transferred. 
                            - Droplet Precautions  are used for a resident with suspected or known infection of microorganism transmitted by droplets.  These droplets can be generated by sneezing, coughing, or talking.  Examples of infections requiring droplet precautions include meningitis, pneumonia, sepsis, pertussis, scarlet fever in infants and young children, influenza, rubella, and mumps.  Droplet precautions are used in addition to standard precautions and include: 

1) *A private room*.  If a private room is not available, the resident may be placed in a room with another resident who has an active infection with the same microorganism, but with no other infection.  If cohorting or a private room is not achievable, a spatial separation of three feet is required. 

2) Masks must be worn when working within three feet of the resident.  Goggles/eye protection should be worn when working within three feet of a resident with a risk of body fluid splashing. 

3) *Transport or move the resident from the room for essential purposes only*.
                            - Contact Precautions  are used for residents with suspected or known infections of colonized microorganisms that can be transmitted by direct or indirect contact with the resident.  Examples include Clostridium Difficile, Escherichia coli O157:H7, Shigella, Hepatitis A or Rotavirus, as well as infections or colonization with multidrug-resistant organisms, i.e., MRSA, VRE, VISA, VRSA, and ESBL-GNB, KPC, CREs, EKM.  Contact precautions are used along with standard precautions and include:

1) *Gloves must be worn when entering the room* and changed after contact with materials that contain high concentrations of microorganisms (fecal material and dressings).  *Gloves are to be removed before leaving the room, and hand hygiene performed immediately with an antimicrobial agent or waterless antiseptic agent*.  After removing gloves and performing hand hygiene, ensure that hands do not touch environmental surfaces or items in the resident’s room.

2) Gowns must be worn when entering the resident’s room if direct care is to be provided or when the potential exists for clothing to be contaminated.  The

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gown is *removed before leaving the room*, and *clothing must not be contaminated by environmental surfaces*. 

3) *Limit resident transport and maintain precautions*. 

4) Resident care equipment should be dedicated to the use of a single resident or cohort of residents infected or colonized with the same pathogen. 

5) Resident placement:  all efforts will be made to cohort residents appropriately.  If not possible, the facility will determine resident placement on a case-by-case basis, balancing infection risk factors and the potential adverse psychological impact on the resident.  The facility will ensure that residents are physically separated (> 3 feet apart) from each other and a curtain is used as a barrier between beds.  PPE will be changed and hand hygiene performed between contact with residents in the same room. 

CMS Ex. 88 at 1-4. 

In response to the Covid pandemic, the CDC warned that, given their “congregate nature” and the residents they serve (older adults, often with underlying chronic medical conditions), nursing home populations are at the “highest risk” of being affected by COVID-19.  If infected, residents are at increased risk of serious illness.  CMS Ex. 132 at 2; *see* CDC Guidance:  People Who Live in a Nursing Home or Long-Term Care Facility, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people -in- nursing-homes.html(last updated Sept. 11, 2020); *see* CMS Ex. 132 at 2.  The CDC recommends that facilities adhere to standard and transmission-based precautions.  CMS Ex. 133 at 4.  

**Improper hand hygiene**.  The surveyors observed multiple instances of staff failing to follow the facility’s policies (as well as standard precautions and CDC guidelines) for hand hygiene. 
                            - As I have already discussed, the wound nurse did not follow standard precautions, facility policies, or CDC guidelines as she treated R18’s wounds.  She treated the resident’s buttock wound immediately after treating his heel wound, without changing her gloves or performing hand hygiene between the procedures.  CMS Ex. 15 at 9-10; CMS Ex. 130 at 3 (Ellis Decl. ¶ 13); CMS Ex. 87 at 1 (requiring staff to follow standard precautions); CMS Ex. 88 at 1 (requiring staff to follow standard precautions); CMS Ex. 88 at 1-2 ( requiring staff to change gloves between tasks and procedures on the same resident; and to perform hand hygiene after gloves are removed ). 

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                            - At 10:30 a.m. on August 27, 2020, the wound nurse treated another resident (R6), who had an incision and drainage from an abdominal abscess.  At the resident’s request, she used supplies that were stored in a bag on the floor.  She put a clean bath towel on the foot of the bed and placed a box of gloves from her treatment cart onto the bed linens, next to the clean field.  She washed her hands, donned gloves, and  removed the soiled dressing from the resident’s groin wound .  She applied Lidocaine and irrigated the wound with a syringe of normal saline.  She then doffed her gloves and donned another pair,  without performing hand hygiene .  She opened a jar of iodoform gauze, retrieved a pair of scissors, and cut off a strip of gauze.  She packed the wound, doffed the gloves and donned another pair, again  without performing hand hygiene .  She retrieved a large gauze pad from the clean field and placed it over the wounds.  She then cleaned up, returning some supplies to the bag on the floor.  She removed her gloves, washed her hands, picked up the box of gloves and returned it to her treatment cart.  CMS Ex. 12 at 109-110.  

The wound nurse later admitted, “I don’t wash my hands after removing a dirty dressing.  I only change my gloves when I am done with the treatment.  I don’t wash my hands after touching a resident either.”  CMS Ex. 12 at 110. 

Thus, the wound nurse again failed to follow standard precautions, facility policies, and CDC guidelines for hand hygiene.  CMS Ex. 87 at 1; CMS Ex. 88 at 1-2.
                            - At 11:15 a.m. on August 27, 2020, the surveyor observed a nurse aide enter another resident’s room (R19).  The nurse aide washed her hands and put on gloves.  She filled a basin with clean water and placed it on an “overbed” with a stack of wash cloths.  She then provided perineal care.  With the same soiled gloves, she emptied the resident’s catheter bag into a graduated pitcher and emptied the pitcher into the toilet.  She returned to the bedside,  without changing gloves or performing hand hygiene .  Wearing the same soiled gloves, she continued to reposition the resident, touching her arms, legs, and sheets.  She moved the basin of water to the bedside table, wet a washcloth, and washed the resident’s face, neck, and underarms.  She then reached into the same basin of water, wet another cloth and rinsed the soap off the resident’s underarms and neck.  CMS Ex. 12 at 110-111. 

Again, *without changing gloves or performing hand hygiene*, the nurse aide rummaged through the resident’s personal items stored in a stacking drawer, and retrieved deodorant, which she applied to the resident’s underarms.  *Still wearing the same gloves*, she repositioned the resident’s legs, assisted her into a clean gown, and placed a clean top sheet over her.  *Before removing her gloves*, the nurse aide rearranged her own face mask and *picked up the soiled linens, which*

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*she held against her uniform and carried out of the room*.  She stated:  “I washed my hands before I started and just now, when I was done.”  CMS Ex. 12 at 111. 

The nurse aide, who apparently had not been trained properly in infection control practices, not only failed to follow standard precautions, facility policies, and CDC guidelines for hand hygiene, she did not follow those directions for handling and transporting linens.  CMS Ex. 87 at 1; CMS Ex. 88 at 1-2. 

**Disregard of isolation precautions** (September Survey).  R5 was on isolation because her frequent doctor visits and hospitalizations put her at risk of contracting COVID-19 from community spread.  CDC guidelines and the facility’s policies required that she remain in her room, with droplet and contact precautions in place.  CMS Ex. 12 at 112; CMS Ex. 124 at 8 (Knight Decl. ¶ 30).  Signage taped to her room door indicated that isolation precautions were in place and directed those entering to wear gloves, a mask, face shield, and gown.  An isolation bin, just outside the room, contained a gown, gloves, and garbage bags.  Isolation barrels were inside the resident’s room for garbage and linens.  CMS Ex. 12 at 112.  Yet, on August 27, 2020, the resident herself was not in the room.  The surveyor found her *sitting in a wheelchair in the activity area, participating in a group activity.  Other residents were within six feet of her*.  CMS Ex. 12 at 112; CMS Ex. 124 at 8 (Knight Decl. ¶ 31).  The facility was thus not following transmission-based precautions (droplet precautions and contact precautions) and its own policies that authorized moving residents “for essential purposes only.”  CMS Ex. 88 at 3, 4. 

A therapy assistant returned R5 to her room.  The assistant entered the room and provided R5 with therapy services.  *She did not put on a gown*.  She was not aware that the resident was in isolation (apparently notwithstanding the sign on her door).  CMS Ex. 12 at 112; *see* CMS Ex. 124 at 8 (Knight Decl. ¶ 31). 

Twenty minutes later, the wound nurse left the dementia unit, pushed the call button to call the elevator, but then walked into R5’s room.  *She did not perform hand hygiene*; *she did not put on a gown*.  After she was in the room, she put on gloves and touched the resident’s skin surrounding her colostomy.  She then removed her gloves and left the room *without performing hand hygiene*.  She later claimed that the resident was out of isolation, so she didn’t have to wear a gown.  CMS Ex. 12 at 112-113; *see* CMS Ex. 124 at 8 (Knight Decl. ¶ 31).  

The therapy assistant and the wound nurse thus disregarded facility policies (and contact/droplet precautions) requiring staff to wear a gown when entering a resident’s room to provide direct care.  CMS Ex. 88 at 4.  The wound nurse again failed to follow standard precautions, facility policies, and CDC guidelines for hand hygiene.  CMS Ex. 87 at 1; CMS Ex. 88 at 1-2. 

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**Disregard of isolation precautions** (October survey).  At the time of the October survey, 18 residents were on transmission-based precautions.  Four had COVID; two had extended spectrum beta-lactamase (ESBL), which is an enzyme produced by a germ, such as E. coli, that causes a variety of illnesses and infections and is spread by contact with bodily fluids or contaminated surfaces.  The remaining residents had potentially been exposed to COVID.  CMS Ex. 103.  The surveyors observed multiple examples of staff disregarding resident care plans as well as contact and droplet precautions. 
                            - Effective October 16, 2020,  R18  was placed on contact/droplet isolation precautions related to his potential community exposure to COVID-19. (He had recently been hospitalized).  Among the interventions listed in his care plan, all staff were instructed to follow the facility policies on isolation.  Isolation barrels were to be placed in his room for linens and trash; carts were to be placed outside his room to store PPE.  Staff were instructed to use proper PPE with all care.  CMS Ex. 93 at 26-27. 

No isolation sign was on R18’s door.  The cart outside his room did not contain PPE.  On October 19, 220, Surveyor Angelia Ellis observed a nurse aide (V5) and a housekeeper (V6) enter R18’s room without wearing gowns; they both left without performing hand hygiene.  When questioned, the housekeeper said that staff did not have to wear gowns in R18’s room.  They wore gowns “only on the COVID side.”  CMS Ex. 15 at 33; CMS Ex. 130 at 4 (Ellis Decl. ¶¶ 17, 18).
                            - One of the facility’s dialysis employees had tested positive for COVID-19, so all residents receiving dialysis were put on contact/droplet isolation.  CMS Ex. 15 at 33; CMS Ex. 129 at 3 (Murphy Decl. ¶ 13).  This included  R72 , who was placed on contact/droplet precautions effective October 13, 2020.  His care plan mirrored R18’s (follow policies, isolation barrels, PPE carts, and proper use of PPE with all care).  CMS Ex. 98 at 1-2.  Yet, no isolation sign was on his door and no isolation cart was outside his door.  CMS Ex. 15 at 33; CMS Ex. 130 at 4 (Ellis Decl. ¶ 18). 
                            - Effective October 16, 2020,  R84  was placed on droplet/contact isolation precautions related to her potential community exposure to COVID-19.  (She had also recently been hospitalized).  Her care plan interventions were the same as R18’s and R72’s (follow policies, isolation barrels, PPE carts, and proper use of PPE with all care).  CMS Ex. 100. 

The same nurse aide (V5) who had entered R18’s room without a gown entered R84’s room without wearing a gown or gloves.  He left the room without performing hand hygiene.  In fact, the surveyor observed this nurse aide enter and leave multiple rooms (isolation and non-isolation) without donning appropriate

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PPE and without performing hand hygiene.  CMS Ex. 15 at 34; CMS Ex. 130 at 4 (Ellis Decl. ¶¶ 17, 18). 
                            - Another nurse aide (V8) entered R84’s room to retrieve the resident’s lunch plates.  He did not wear a gown.  He then entered and left multiple rooms (isolation and non-isolation) without donning appropriate PPE or performing hand hygiene.  CMS Ex. 15 at 34-35. 
                            - Both  R42  and  R64  had been placed in contact/droplet isolation after emergency room visits.  Yet, on October 26, 2020, the surveyor observed an LPN walk into their room without donning a gown or gloves.  The nurse left their room without performing hand hygiene.  She threw a medication cup away on her cart and returned to the room.  When she left the room the second time, she returned to the medication cart and began turning pages in the Medication Administration Record, without performing hand hygiene.  CMS Ex. 15 at 35. 
                            - R13  was a dialysis patient who had been placed on contact/droplet isolation, and the appropriate isolation sign was on her door.  On October 19, 2020, Surveyor April Murphy observed a nurse (V19) passing medications.  The nurse entered R13’s room without putting on a gown or gloves.  When she left the room, she went straight to the medication cart and began preparing medications for other residents.  When questioned, she admitted that she knew that the resident was on contact/droplet precautions, although she didn’t know why.  CMS Ex. 15 at 36; CMS Ex. 129 at 3 (Murphy Decl. ¶ 14). 
                            - R47  had recovered from COVID-19 but was at risk for respiratory infection.  CMS Ex. 97 at 10.  Because of a stroke, he needed staff to perform range-of-motion exercises with him.  CMS Ex. 97 at 43-44.  On October 21, 2020, Surveyor Murphy observed a restorative certified nursing assistant assisting R47  with range of motion exercises.  She wore her mask below her nose, which violates CDC guidelines.  Because the nose is a point of entry and exit for infections, failing to cover the nose renders a mask ineffective.  CMS Ex. 129 at 3 (Murphy Decl. ¶ 16); CMS Ex. 135 (requiring that “both mouth and nose” be protected by the face mask). 

Petitioner has not responded to any of these findings.  It produces no testimony from any staff member suggesting that the surveyors were mistaken.  Because it did not follow its own policies, standard and transmission-based precautions, and CDC guidelines, the facility was not in substantial compliance with section 483.80.  
                            The facility was not in substantial compliance with 42 C.F.R. § 483.12(c) because staff did not timely report, to the facility administrator, evidence that a resident’s narcotic pain medication had been misappropriated, and the

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*****administrator did not report the alleged misappropriation to the state agency.  (December 9 survey)*****

**Program requirement:  42 C.F.R. § 483.12(c) (Tag F609)**.  As part of the regulation that ensures for facility residents the right to be free from abuse, neglect, and exploitation, the facility must ensure that *all* alleged violations involving exploitation, *including misappropriation of resident property*, be reported immediately to the facility administrator and to the state agency and adult protective services, but*not later than 24 hours after the allegation is made*, if the events that cause the allegation do not involve abuse or result in serious bodily injury (which require reporting within two hours). 

**Facility policy:  reporting requirements**.  As part of its policy for preventing mistreatment, neglect, exploitation, *misappropriation of resident property*, and abuse, the facility required staff to report and investigate any *allegation or suspicion* that resident property had been misappropriated.  CMS Ex. 114 at 6-11.  Reflecting the requirements of the regulation, the policy requires facility employees to report the allegation or suspicion to the facility administrator or to an immediate supervisor, who must immediately report to the administrator or designee.  CMS Ex. 114 at 6.  Reports should be documented, and a record kept of the documentation.  The resident’s physician and representative must be notified of the allegation.  CMS Ex. 114 at 7*. *

The policy also requires the facility to investigate the allegation that resident property was misappropriated.  At a minimum, the appointed investigator must interview the person who reported, anyone likely to have knowledge of the incident, and the resident, if she can be interviewed.  Any pertinent medical records or other documents must be reviewed.  If the allegation is against an employee, the investigator must interview residents and employees for whom and with whom the employee worked “to determine whether anyone has witnessed any prior . . . misappropriation of resident property by that employee.”  CMS Ex. 114 at 8*. *

Within five working days of the incident, the investigator will report the conclusions of the investigation, in writing, to the administrator or designee.  The report must include:  the name, age, diagnosis, and mental status of the resident involved; the original allegation; facts determined during the investigation; conclusions based on known facts; if police were notified, a report number; and, if the allegation against an employee is determined valid, a separate sheet with the employee’s information.  CMS Ex. 114 at 9*. *

The administrator or designee must review the report and forward a final written report to the state agency within five working days of the reported incident.  The administrator or designee will also inform the resident or representative of the investigation’s results and any corrective action taken.  CMS Ex. 114 at 9*. *

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The policy also includes requirements for external reporting.  The facility must notify the resident’s representative and the state agency “immediately by telephone or fax” that an occurrence of potential misappropriation has been reported and is being investigated.  The written report should include:  the name, age, diagnosis, and mental status of the resident involved; description of the occurrence; date, time, location, and circumstances of the alleged incident; and police notification, if any.  If the events that caused the allegation do not involve abuse or result in serious bodily injury, the incident must be reported within 24 hours.  Within five working days after the occurrence, a complete written report must be sent to the state agency.  CMS Ex. 114 at 9-10.* *

**Resident 4 (R4)**.  R4 was an 86-year-old woman, initially admitted to the facility on February 2, 2019, and readmitted on December 16, 2019.  CMS Ex. 117 at 1; CMS Ex. 131 at 3 (Wiening Decl. ¶ 11).  She suffered from a long list of impairments, including dementia, Alzheimer’s disease, history of a stroke, osteoarthritis, and rheumatoid arthritis.  She had a history of falls.  CMS Ex. 117 at 2.  R4’s arm was deformed because of her rheumatoid arthritis, which caused her considerable pain.  To address her pain, her physician prescribed Tramadol, to be administered three times a day.  CMS Ex. 18 at 11; CMS Ex. 117 at 5; CMS Ex. 131 at 3 (Wiening Decl. ¶ 11).  Tramadol is an opioid that is prescribed to treat moderate to severe pain.  Because of its potential for misuse, physicians have been instructed to prescribe Tramadol only for pain that does not respond to non-opioid pain medications.  https://www.ncbi.nlm.nih.gov/books/NBK537060.  

Surveyor Rhonda Wiening, R.N., reviewed R4’s medication administration chart, which showed that R4 was not administered 12 doses of the pain medication.  Failing to administer the medication, as ordered, had a “negative impact” on the resident’s levels of pain.  Staff told her that the medication was not administered because it went missing.  CMS Ex. 18 at 10; CMS Ex. 117 at 6; CMS Ex. 131 at 3 (Wiening Decl. ¶ 11).39

Facility records show that, on November 9, 2020, an LPN (identified as V14) accepted delivery of 60 tablets of Tramadol (two cards of 30 pills each), prescribed for R4.  The LPN did not sign for the medication, although her name is on the packing slip. CMS Ex.

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18 at 2-3; CMS Ex. 118; CMS Ex. 131 at 3 (Wiening Decl. ¶ 12).40  Surveyor Wiening testified that she questioned staff about what happened to the narcotics, but no one gave her a “straight answer.”  An LPN (identified as V19) told her that, on November 19, she noticed that the resident needed more Tramadol.  She faxed a refill order to the pharmacy, but the next day she learned that the pharmacy reported that it was too early for a refill.  The LPN did not then report the problem. 

V14 said that she found out about the missing medication on November 23, called the pharmacy directly to request more, and was also told that it was too soon.  There is no record of this call.  CMS Ex. 18 at 3, 6; CMS Ex. 131 at 3 (Wiening Decl. ¶ 12).  She did not then report that the drugs were missing.  Nothing in the record suggests that she ever denied receiving the full complement of drugs on November 9, so she had ample reason to be suspicious. 

Surveyor Wiening interviewed the pharmacy’s customer service representative, who disputed V14’s claim.  He said that, between November 20 and 24, no one from the facility had contacted the pharmacy requesting a Tramadol refill.  He also confirmed that the pharmacy had delivered the full dose of the medication on November 9.  CMS Ex. 18 at 7; CMS Ex. 131 at 3 (Wiening Decl. ¶ 12). 

Thus, contrary to regulatory reporting requirements and the facility’s policy, staff did not timely report the missing opioids to the facility’s administrator.  The facility’s DON told Surveyor Wiening that she was did not learn of the missing drugs until November 25, when V14 wrote her a note (which the DON produced for the surveyor’s review) telling her that she could not find the 30 pills.  CMS Ex. 18 at 6; CMS Ex. 131 at 3 (Wiening Decl. ¶ 13).  The facility’s administrator also told Surveyor Wiening that she did not learn about the missing medication until November 25.  CMS Ex. 131 at 3 (Wiening Decl. ¶ 14).  The staff’s failing to report the suspicion that the drugs had been misappropriated put the facility out of substantial compliance with section 483.12(c).* *

The facility’s administrator compounded the violation because she did not report the missing medication to the state agency.  She claimed that she had not finished investigating the medication’s disappearance, that she believed the pharmacy had not sent

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it, and that she “only reported issues if the allegation was substantiated.”  CMS Ex. 18 at 4; CMS Ex. 131 at 3 (Wiening Decl. ¶ 14).* *

Petitioner argues that it was not required to report the missing narcotics because “things can go missing,” particularly medications.  Handling medications “involve[s] a whole host of moving parts,” according to Petitioner, “from delivery through placing the items on the medications cart.”  In Petitioner’s view, because “not every missing item or missing medication would create a **reasonable** suspicion that misappropriation has occurred,” the facility “must first look into the matter more.”  P. Br. at 19 (emphasis in original).  I find this argument disingenuous.  The disappearance of a narcotic medication strongly suggests that the property has been misappropriated.  Of course, the facility must “look into the matter,” but the very fact that it must investigate triggers its duty to report timely.* *

Petitioner submits an undated “internal review” of the incident, inexplicably absolving itself and concluding that the pharmacy was at fault.  The review blames the pharmacy because, although the manifest had the name of the receiving nurse typed out, it “did not have a signature as pharmacy courier signed the line instead due to COVID 19,” which “is not consistent with the [f]acility’s expectation of pharmacy deliveries, which must be reviewed and counted by receiving nurse in the presence of the pharmacy delivery person.”  P. Ex. 8 at 12.  Petitioner does not explain why the receiving nurse could not have counted the narcotics (as she should have) with or without the courier present.  In fact, the facility’s policy required the receiving nurse to provide “a written or electronic signature to the courier/driver as proof of delivery.”  CMS Ex. 113.  If the count was off, she could and should have reported the problem immediately. 

Moreover, even if the pharmacy were completely at fault (which it was not), the facility is accountable.  42 C.F.R. § 483.21(b)(3) (requiring that services arranged by the facility meet professional standards of quality).  

The reporting requirements are triggered by any allegation of misappropriation, whether or not it is recognized as such by the facility.  See Beverly Healthcare Lumberton v. Leavitt, 338 F. App’x. 307, 313 (4th Cir. 2009) (agreeing that the facility’s failure to implement its policies for reporting and investigating abuse “indicated a wider systemic problem in the facility” that leaves its residents “at real risk for serious harm”); Rockcastle Health & Rehab. Ctr., DAB No. 2891 at 11 (2018).  By failing to report an allegation or suspicion of abuse, neglect, exploitation (which includes misappropriation of resident property), the facility is not protecting its residents, and is therefore not in substantial compliance with section 483.12(c).  Rosewood Care Ctr. of Swansea, DAB No. 2721 at 9-10 (2016), aff’d, Rosewood Care Ctr. of Swansea v. Price, 868 F.3d 605, 619 (7th Cir. 2017); Century Care of Crystal Coast, DAB No. 2017 at 25 (2007) (concluding that, where an incident went unreported and uninvestigated, the facility could not even identify, much less correct, the flaws in its systems). 

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                            The facility’s deficiencies posed immediate jeopardy to resident health and safety.
  

**Immediate jeopardy**.  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.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  Heritage House, DAB No. 3035 at 21 (citing Franklin Care Ctr., DAB No. 2869 at 9 (2018); Britthaven of Havelock, DAB No. 2078 at 29 (2007), aff’d, 910 F.3d 919 (7th Cir. 2018)).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Heritage House, DAB No. 3035 at 21-22; Barbourville Nursing Home, DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007)). 

As the above discussion establishes, the facility was not in substantial compliance with Medicare program requirements because it failed to provide its residents with the goods and services they needed to avoid suffering physical harm, pain, mental anguish, and emotional distress.  By any standard, the facility’s substantial noncompliance posed immediate jeopardy to resident health and safety.* *

The record is replete with situations in which residents were harmed or likely to suffer serious harm from the facility’s failures, including:  staff’s repeated failures to assess and treat wounds and pressure ulcers for residents at high risk for skin breakdown (e.g., R1, R40, R95, R62/18); staff’s inability or unwillingness to provide facility residents with basic care, such as showers, answering call lights, getting residents out of bed, taking them to the bathroom.  Because the facility did not have the equipment and staff it needed to transfer its residents, particularly its morbidly obese residents, they missed critical medical appointments.  Any one of these deficiencies involving any one of the multiple residents affected by them would justify a finding of immediate jeopardy.41

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Because the facility’s deficiencies caused and were likely to cause serious harm, CMS’s determination that those deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.
                            The penalties imposed are not unreasonably high. 

To determine whether the CMP is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance, including repeat deficiencies; 2) the facility’s financial condition; 3) 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.  The absence of culpability is not a mitigating factor.  The factors 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. 

I consider whether the evidence supports a finding that the amount of the CMP is at a level *reasonably related to an effort to produce corrective action by a provider* with the kind of deficiencies found, and in light of the above factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  *Barn Hill Care Center*, DAB No. 1848 at 21 (2002); *Community Nursing Home*, DAB No. 1807 at 22 *et seq*. (2002); *Emerald Oaks*, DAB No. 1800 at 9 (2001); *CarePlex of Silver Spring*, DAB No. 1638 at 8 (1999).  

I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty.  *Crawford Healthcare and Rehab.,* DAB No. 2738 at 20 (2016). 

The burden is on the facility to demonstrate that a reduction is necessary to make the CMP amount reasonable.  *Heritage Plaza Nursing Ctr.*, DAB No. 2017 at 22 (2017).  

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, May 13, 2021.  CMS Ex. 3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020).  CMS imposed penalties of $5,090 per day for 15 days of immediate jeopardy, and $270 per day for 107 days of substantial noncompliance that did not pose immediate jeopardy, for a total penalty of $105,240.

The $5,090 penalty imposed for the period of immediate jeopardy is impermissibly *below* the minimum amount called for in situations of immediate jeopardy ($6,808 to $22,320).  While within the regulatory range, the $270 per day penalty is at the very low end of it

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($112 to $6,695).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 85 Fed. Reg. 2869, 2880 (Jan. 17, 2020). 

Had CMS imposed the minimum penalty amounts authorized by the regulation, the total penalty here would be significantly *higher* than the penalty amount CMS has imposed.  At the time the penalty was imposed, the minimum per day penalty for situations of immediate jeopardy was $6,808 per day.  The minimum per day penalty for each day of substantial noncompliance that did not pose immediate jeopardy was $112 per day.  The total penalty for the entire period of noncompliance had to be at least **$114,104**, ($6,808 x 15 = **$102,120**; $112 x 107 = **$11,984**; $102,120 + 11,984 = **$114,104**). 

In reducing the penalty amounts by 50%, CMS did not consider that the regulation imposes minimum amounts.  Whether I review the penalty based on per-day amounts (as I should) or the total amount, the final penalties imposed fall below the minimum amounts authorized by the regulations.  Except to assert that CMS “exercised its discretion,” to reduce the penalty, CMS has not explained what authority gave it the discretion to violate the regulations.  CMS Rebuttal at 14.  CMS argues that, “as a matter of law,” I lack the authority to set the penalty below the regulatory minimum.  I agree.  However, “as a matter of law,” CMS also lacks the authority to set the penalty below the regulatory amount.  *Oceanside Nursing and Rehab. Ctr.,*DAB No. 2382 at 23 (2011) (concluding that, even accepting the facility’s claims of financial hardship, the Board “could not, by law, reduce the total below . . . the minimum per-day CMPs for immediate and non-immediate jeopardy periods).  I will not compound CMS’s error by reducing the penalty further, particularly considering that the relevant factors justify a much higher penalty, notwithstanding the facility’s purported financial situation.*42 *

The remaining issue is whether the $270 per day penalty for the period of substantial noncompliance that did not pose immediate jeopardy is reasonable.  Based on the relevant factors, the amount is not unreasonably high.

The facility has a terrible compliance history, which would justify a substantial increase in the penalty amounts.  CMS Ex. 5; *See Generations at Rock Island,*DAB CR6128 (2022); *Generations at Rock Island*, DAB No. CR5989 at 9-10 (2021) (discussing, in some detail, this same facility’s poor compliance history, including past findings of

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immediate jeopardy);**see**CMS Br. at 37.  For the most part, the penalties imposed have been minimal to nonexistent and were insufficient to compel the facility to achieve and maintain substantial compliance.* *

CMS has already reduced the penalty based on Petitioner’s claim of financial hardship.  Because I must affirm a penalty of at least $112 per day, the amount remaining in question involves just $16,906, the difference between the amount actually imposed, $28,890 ($270 x 107), and the minimum penalty amount, $11,984 ($112 x 107).  I must accept CMS’s judgment that the facility’s financial condition justified lowering the penalties significantly; however, Petitioner has not justified any further reduction 

It is well-settled that the facility has the burden of proving, by a preponderance of the evidence, that paying the CMP would render it insolvent or would compromise the health and safety of its residents.  *Van Duyn Home and Hosp.,* DAB No. 2368 (2011); *Gillman Care Ctr.,* DAB No. 2357 (2010).  To meet the standard for lowering a CMP based on financial condition, claims must be supported by compelling documentation.  In *Guardian Care Nursing & Rehab. Ctr.,*DAB No. 2260 (2009), for example, the facility could not even afford to represent itself on appeal.  Its Medicaid census was 90%; its annual shortfall was $250,000; and it relied on charitable contributions for its continuing viability.  Citing inadequate financial documentation, the Board concluded that the facility had not established that additional resources would not be available.

Here, the facility does not rely on charitable contributions to keep it afloat.  As CMS points out, the facility is part of a network of 12 facilities run by a for-profit limited liability corporation.  CMS Ex. 81 at 1-2; CMS Br. at 38, citing**Generations Healthcare Network*,*https://generationshealthcarenetwork.com/communities).  Petitioner complains that the facility is not profitable and that its home office has had to subsidize its expenses.  If anything, this establishes that the facility has an additional source of revenue that could be used to pay the penalty.  These additional resources cannot be ignored.  To do so “could ‘be an open invitation for skilled nursing facilities to avoid paying’ CMPs by encouraging them ‘to contend that they must be treated as isolated facilities regardless of the financial wherewithal of the entity or individual that owns them along with other similar facilities.’”*  *Oceanside,**DAB No. 2382 at 23, citing **Oceanside Nursing and Rehab. Ctr.,**DAB CR2269 at 17 (2011). 

Applying the remaining factors, I have discussed in some detail the facility’s significant neglect of its residents as well as its failures to ensure their health and safety.  For these shortcomings, the facility is culpable.  Although the multitude of serious problems and the harm inflicted on the facility’s residents justify a substantial penalty, CMS has imposed minimal (and sub-minimal) penalties.  I therefore conclude that the penalties imposed are not unreasonably high. 

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### Conclusion

From August 27 through December 27, 2020, the facility was not in substantial compliance with Medicare program requirements.  From August 27 through September 10, 2020, its deficiencies posed immediate jeopardy to resident health and safety.  The penalty imposed for the period of immediate jeopardy – $5,090 per day for 15 days – is, if anything, impermissible low.  It falls below the regulatory minimum.  The penalty imposed for the period of substantial noncompliance that did not impose immediate jeopardy – $270 per day for 107 days of substantial noncompliance that did not pose immediate jeopardy – is not unreasonably high. 

----

### Endnotes

1   As discussed below, the penalties are, in fact, too low.  CMS improperly reduced the immediate jeopardy penalty below the regulatory minimum. 

2    I highlight, in bold, the deficiencies that the parties address, which, as the following discussion shows, would more than justify the penalties imposed, even if I disregarded the remaining deficiencies (which I do not). 

3    The surveyors cited some additional deficiencies but, following Informal Dispute Resolution (IDR), the state agency removed them, and CMS accepted the changes.  42 C.F.R. § 488.431(c); *see* Act § 1919(h)(6)(B); 42 C.F.R. § 452(a)(2); *Britthaven of Chapel Hill,* DAB No. 2284 at 8-9 (2009). 

4   Two additional deficiencies were cited but deleted following IDR.  CMS Ex. 10.  

5    CMS also approved an extended payment plan, which required Petitioner to pay interest on the unpaid amount.  This explains the discrepancy between the penalty imposed and the amount the facility ultimately owed.  I have no authority to review the terms of the repayment plan.  *See* 42 C.F.R. § 498.3(b) (listing the initial determinations that may be appealed). 

6    On October 7, December 3, and December 20, 2020, January 14, January 22, and January 25, 2021, surveyors investigated additional complaints but found that they were not substantiated and cited no deficiencies.  CMS Ex. 5 at 1; *see* CMS Br. at 4 n.1.  Petitioner has not mentioned these instances, which undercut its allegation that surveyors are “in a building for the purpose of finding and writing citations.” 

7    I note that counsel is familiar with this standing order, having represented the facility in multiple cases in which this or similar orders were issued.  *See, e.g., Generations at Rock Island*, DAB CR6128 (2022); *Generations at Riverview*, DAB No. 6046 (2022); *Generations at Rock Island*, DAB CR5989 (2021); *Generations at Peoria*, DAB No. 5819 (2021). 

8    Deciding a case based on the written record does not mean that it is decided without a hearing.  In reviewing administrative appeals, courts recognize that, by considering the evidence and applying the law, the ALJ has granted the petitioner a hearing, even if that hearing was not an “oral” or “evidentiary” 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.”). 

9    As discussed below, I determine whether penalties are reasonable based on the per-day penalty, not the total accrued amount.  *Crawford Healthcare and Rehab.*, DAB No. 2738 at 20 (2016); *see* 42 C.F.R. § 488.438(f).  Although CMS did not specifically articulate the reduced per day amounts, I infer that each was reduced by 50% – which means CMS imposed penalties of $5,090 per day for the period of immediate jeopardy and $270 per day for the period of substantial noncompliance that did not pose immediate jeopardy.  The alternative would be to consider first whether, but for the financial hardship factor, the original per day penalties ($10,180 and $540 per day) are reasonable and then to apply the financial condition factor to the total penalty.  The result would ultimately be the same. 

10     My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.  

11  The regulations governing long-term care facilities were revised in October 2016.  The regulation governing abuse and neglect was moved from section 483.13 to 483.12, and the quality-of-care regulation, 42 C.F.R. § 483.25, was reconfigured.  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017).  The substance of the regulations did not change, however, so decisions that predate the regulatory changes remain valid. 

12  The regulation requires that *all alleged violations* be reported and investigated.  Facility staff may not disregard an allegation because they do not consider an “insensitive action” to be abuse (or neglect).  *See Britthaven, Inc.,* DAB No. 2018 at 15 (2006), citing *Cedar View Good Samaritan,* DAB No. 1897 at 11 (2003). 

13  Again, this provision seems inconsistent with the regulation, which requires that *all**allegations* be reported, not just allegations that result in a determination of mistreatment. 

14  This provision is also not consistent with the regulation, which requires the facility to report the results of the investigation within five working days *of the incident*.  42 C.F.R. § 483.12(c)(4). 

15  The record is filled with employee statements admitting and explaining that facility staff were unable to provide adequate care to many residents.  Petitioner has not challenged the truth of these employee statements, and the individuals who made them have not refuted them.  *See**Beatrice State,* DAB No. 2311 at 17, 18;*Omni Manor*, DAB No. 1920 at 11; *see Richardson v. Perales,* 402 U.S. 389, 410 (1971).   

16  Tunnelling occurs when a wound has progressed to form passageways beneath the surface of the skin.  Undermining occurs when the tissue under the wound edges becomes eroded, resulting in a pocket beneath the skin at the wound’s edge. 

17   The facility provided dialysis in-house.  It seems to have had a problem with severely compromised, but cognitively intact, residents refusing dialysis at the facility (although not necessarily in the hospital), even though they risked serious health consequences.  No evidence suggests that the facility investigated why some of its residents were willing to risk their health (and even their lives) to avoid dialysis in the facility. 

18  Shearing occurs when skin is moved against a fixed surface, which can cause a debilitating tissue injury. 

19  R40 was not the only resident to voice this complaint.  The surveyors cited instances where other, less challenging residents, who should have been up and about, were left in bed.  R95, for example, complained that staff refused to get her out of bed.  CMS Ex. 12 at 14-15. Moreover, as discussed below, staff told Surveyor Barbara Vineyard, R.N., that the slings were kept in the basement and the facility often did not have enough staff on duty so that someone could leave the unit and retrieve the equipment.  CMS Ex. 125 at 4 (Vineyard Decl. ¶ 17); *see* discussion below. 

20  Because the facility’s record-keeping practices were inadequate, CMS cited a deficiency under section 483.20(f) and 483.70(i).  CMS Ex. 12 at 103-106.  Petitioner has not pursued the issue. 

21  Bariatric (“Barri”) slings cost $149 apiece.  CMS Ex. 66 at 5.  

22  CMS determined that the facility was not in substantial compliance with section 483.21(b), and Petitioner has not pursued that determination.  CMS Ex. 12 at 32-37*. *

23  R40 should probably have had her own sling.  CMS Ex. 66 at 4 (requiring the individual patient name for whom the sling was ordered and instructing that “Generations at Rock Island, Use” should not be used.”). 

24  Although CMS has not stressed the issue, R40 also had a serious eating disorder, which the facility did not address in any meaningful way.  Besides occasionally documenting what she had ordered from fast-food restaurants, the facility’s sole intervention seems to have been staff telling her to stick to her diet, an ineffective intervention.  The facility should have considered alternative approaches, but no evidence suggests that it did. 

25  I describe below a noncompliant facility’s burden to demonstrate, affirmatively, that it has corrected its deficiencies and achieved substantial compliance. 

26  When the regulations were revised, the requirement that facilities minimize the risk of accidents was moved from 42 C.F.R. § 483.25(h) to 483.25(d).  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (Jul. 13, 2017).  Again, the substance of the “quality- of-care” requirements – which are statutory – has not changed, so decisions that pre-date the regulatory changes remain valid. 

27  We also know that the fall log is not complete.  For example, R74 fell on September 13, 2020 (see discussion below), yet his fall is not listed in the log.  CMS Ex. 99 at 7; CMS Ex. 63 at 2.  

28  The resident face sheet for R94 indicates that her room was on the fourth floor.  It does not indicate any room number.  CMS Ex. 59 at 1.  Her progress notes leave blank the space where unit and room number should be filled in.  CMS Ex. 59 at 43-62.  The report of her June 7, 2020 fall, says “unassigned room.”  CMS Ex. 59 at 33.  This is puzzling; the resident obviously must have been occupying some room. 

29  The facility must conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies.  The assessment must include, among other requirements, the resident population, including the care required by the resident population, considering the types of diseases, conditions, physical and cognitive disabilities, overall acuity, and other pertinent facts present within the population.  42 C.F.R. § 483.70(e). 

30  The administration’s refusal to cooperate, its inability or unwillingness to produce records, and other failures put the facility out of substantial compliance with 42 C.F.R. § 483.70, one of many cited deficiencies that Petitioner has not pursued.  CMS Ex. 12 at 93-103. 

31  This explains many of the problems, described above, with the facility lacking adequate equipment to transfer its residents; they may have had it, but they couldn’t retrieve it.  I find it baffling that the facility kept this vital equipment – which it should have been using multiple times a day – in such an inaccessible place. 

32  The report to the state agency inaccurately attributes the witness (roommate) statements to the resident.  CMS Ex. 48 at 11. 

33  Since the incident included an allegation of abuse, the facility was required to investigate thoroughly and to report the results of its investigation to the state agency within five working days of the incident.  42 C.F.R. § 483.12(c).  I see no evidence that the facility “investigated thoroughly.”  The investigator spoke to the accused and to a second nurse.  She did not interview the resident or his roommate, who witnessed the incident, and did not interview the nurse aide on duty.  CMS Ex. 12 at 102.  The incident should have been reported to the state agency no later than August 28, 2020.  CMS has not pursued these issues, however. 

34  The assessment documented an average resident census of 85.  Nearly half of these residents had problems with urinary incontinence and were documented fall risks.  Almost 40% required assistance with activities of daily living.  CMS Ex. 82 at 3; CMS Ex. 128 at 2 (Roos Decl. ¶ 10); *see* P. Ex. 7 (showing an average resident census of 87 from October 13 through 26, 2020). 

35  Staff are instructed not to do what Petitioner appears to do here, criticize a resident who resists care.  P. Ex. 7 at 13. 

36  As noted above, section 483.70(e) mandates that the facility conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies.* *

37  Since the time periods relevant to these cases, the regulation was redesignated from 42 C.F.R. § 483.65 to 42 C.F.R. § 483.80.  81 Fed. Reg. 68,688 (Oct. 4, 2016). 

38  “Cohorting” refers to grouping individuals with the same condition in the same location (room, wing, building). 

39  The facility administrator claimed, in her “internal review,” that “no adverse reactions [were] noted.”  P. Ex. 8 at 13.  The record includes no underlying support for this assertion.  R4’s progress notes include no pain assessments.  *See* CMS Ex. 117.  Inasmuch as the resident was not receiving the powerful pain medication she had been prescribed, I would have expected staff to monitor closely her levels of pain.  The report also says that the resident’s nurse practitioner was notified and changed the prescription to “as needed.”  P. Ex. 8 at 13.  No such change is reflected in the list of the resident’s medication orders.  CMS Ex. 117 at 5. 

40  Because staff failed to follow pharmacy procedures and complete controlled substance reconciliation records, the facility was not in substantial compliance with 42 C.F.R. § 483.45(a), (b), which require the facility to provide pharmaceutical services, including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs.  Because they did not administer the medications as ordered, missing 12 doses, they were not in substantial compliance with 42 C.F.R. § 483.45(f), which requires that the facility keep its residents free of any significant medication errors.  Petitioner has not pursued its appeal of these deficiencies.  *See*CMS Ex. 18 at 4-12. 

41  In fact, the facility dodged a major bullet with respect to CMS’s determination as to the duration of the immediate jeopardy.  Notwithstanding the facility’s serious and ongoing staffing and infection-control deficiencies, CMS determined that the immediate jeopardy was abated effective September 11, 2020.  *See, e.g.*, *Golden Living Ctr. – Superior,* DAB No. 2768 at 25-26 (concluding that it was not erroneous for CMS to determine that the facility’s failure to implement – fully and promptly – influenza control precautions posed immediate jeopardy to resident health and safety); *Westgate Healthcare Ctr.,* DAB No. 1821 at 24 (2002) (finding that the facility’s inadequate staffing caused actual harm that posed immediate jeopardy to resident health and safety). 

42  Neither party has asked me to enforce the regulation, which sets a minimum penalty amount.  Before I reverse CMS’s determination to reduce the penalty below the minimum, I would have to allow the parties to address the issue, which would delay resolution of this already aged case.  I, therefore, reluctantly, decline to increase the penalty to comport with the regulation.  However, the parties are now on notice of the issue, and, if given the opportunity to address it, the Board may decide that it is obligated to enforce the statute and regulations, notwithstanding CMS’s unwillingness to do so.  *See Oceanside,* DAB No. 2382 at 23. 

Carolyn Cozad HughesAdministrative Law Judge