Generations at Elmwood Park, DAB CR6823 (2026)

DECISION

Petitioner, Generations at Elmwood Park, was not in substantial compliance with Medicare program participation requirements from January 29 through May 19, 2022, due to multiple violations of the participation requirements established by 42 C.F.R. pt. 483.1  The regulatory violations posed a risk for more than minimal harm and amounted to noncompliance, which is a basis for the imposition of enforcement remedies.  The following enforcement remedies are reasonable:

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A per day civil money penalty (CMP) of $1,537.25 per day for 111 days of noncompliance for the period January 29 through May 19, 2022 – a total CMP of $170,634.75; and

A denial of payment for new Medicare admissions (DPNA) from April 5 through May 19, 2022.

I.  Background

Petitioner is in Elmwood Park, Illinois and participates in Medicare as a skilled nursing facility (SNF).  Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 12; Joint Stipulation of Facts (Jt. Stip.) at 1 ¶ 1.  On March 10, 2022, the Illinois Department of Public Health (state agency) completed an annual license and certification survey and a complaint investigation at Petitioner.2  CMS Ex. 2.  On April 19, 2022, the state agency completed complaint investigations at Petitioner.  CMS Ex. 3.  On May 3, 2022, the state agency completed an additional complaint investigation at Petitioner.  CMS Ex. 4.  The state agency surveyors concluded that Petitioner was not in substantial compliance with program participation requirements based on their survey and investigations.  CMS Exs. 2, 3, 4, 12; Jt. Stip. at 1-3 ¶¶ 2-10.  On June 13, 2022, the state agency conducted a revisit survey of Petitioner.  The state surveyors concluded that Petitioner returned to substantial compliance with program participation requirements effective May 20, 2022.  Jt. Stip. at 3 ¶¶ 11-13; CMS Ex. 5.

CMS notified Petitioner of its initial determination accepting the state agency findings and conclusions of noncompliance from the survey and investigations and the imposition enforcement remedies:

A per day civil money penalty (CMP) of $2,365 per day for 111 days of noncompliance for the period January 29 through May 19, 2022 – a total CMP of $262,515; and

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A denial of payment for new Medicare admissions (DPNA) from April 5 through May 19, 2022.

CMS Ex. 12 at 1-2; Jt. Stip. at 3 ¶ 14.  CMS also informed Petitioner that it was ineligible to conduct a nurse aide training and competency evaluation program (NATCEP).  CMS Ex. 12 at 4.  The parties stipulated that on October 5, 2022, CMS lowered the per day CMP to $1,537.25 and the total CMP amount to $170,634.75, based on Petitioner’s August 31, 2022 financial hardship filings.  Jt. Stip. at 3 ¶ 15.

Petitioner requested a hearing before an administrative law judge (ALJ) on October 7, 2022 (RFH).  The case was assigned to me for hearing and decision on October 11, 2022, and my Standing Order was issued at my direction.

In their March 13, 2023 joint status report, the parties waived an oral hearing and requested a decision on the written record.  On March 20, 2023, I accepted the waiver of oral hearing subject to 42 C.F.R. § 498.66(b)(1) and set a briefing schedule.  On April 19, 2023, CMS and Petitioner filed opening briefs (CMS Br. and P. Br., respectively) with proposed findings of fact and conclusions of law.  CMS and Petitioner filed reply briefs on May 19, 2023 (CMS Reply and P. Reply, respectively).

CMS offered CMS Exs. 1 through 87 as evidence and Petitioner offered Petitioner’s exhibits (P. Exs.) 1 through 19 as evidence.  Petitioner objected to my consideration of CMS Exs. 7, 41, 55, 61, 71, and 77 on grounds that the documents contain hearsay.  Evidence is not excluded on the basis that it is hearsay so long as it is relevant and authentic.  42 C.F.R. §§ 498.60(b)(1), 498.61.  Petitioner does not dispute the authenticity of the documents or their relevance.  Petitioner’s hearsay objections go to the weight of the evidence.  I do consider the hearsay nature of evidence when weighing the evidence.  I note that if Petitioner wanted to clarify the contents of CMS Exs. 61, 71, and 77 (surveyor notes); CMS Ex. 41 (a wound policy and procedure); or CMS Ex. 55 (a police report) Petitioner had the option to subpoena the persons who made the documents to testify as witnesses at the hearing that Petitioner elected to waive.  Petitioner also objects to CMS Ex. 7 – without citation to any authority – on grounds that it violates Petitioner’s due process rights because the exhibit contains evidence of prior uncontested findings of noncompliance.  Petitioner argues that alleged noncompliance it had no opportunity to contest should not be considered in assessing the reasonableness of the CMP under 42 C.F.R. § 488.438(f).  CMS Ex. 7 is a document titled “AEM Nursing Home Enforcement History” and purportedly reports Petitioner’s history of compliance with Medicare participation requirements and prior enforcement history from January 10, 2019, through October 11, 2022.  Petitioner does not dispute the authenticity of CMS Ex. 7 or that it is relevant for consideration under 42 C.F.R. § 488.438(f).  Although, I will not exclude the relevant and authentic CMS Ex. 7, I note that I give no weight to any reported noncompliance for which no enforcement remedy was imposed because Petitioner would not have had the opportunity to contest the alleged noncompliance.

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More importantly, I give no weight because CMS imposed or approved no enforcement remedy indicating the agency did not consider the alleged noncompliance to merit the imposition of an enforcement remedy.  Accordingly, Petitioner’s objections to CMS Exs. 7, 41, 55, 61, 71, and 77 are overruled and CMS Exs. 1 through 87 are admitted and considered as evidence.

CMS objected to my consideration of P. Ex. 2 pages 3 through 5 and 9 through 13 because the pages record the status of pressure ulcers and care provided to Resident 133 for those wounds on dates after the survey that ended on March 10, 2022.  CMS argues that the evidence is not relevant to determine whether Petitioner was noncompliant at the time of the survey.  Petitioner urges consideration of P. Ex. 2 pages 3 through 5 and 9 through 13 as evidence that Resident 133’s wound status improved based on the treatment plan Petitioner implemented prior to the March 2022 survey.  I conclude the evidence is relevant, even though it is dated after the survey was completed on March 10, 2022, because it may show improvement in the resident’s wounds based on Petitioner’s plan of care even though after the survey, and the evidence may also show the wounds were not unavoidable contrary to Petitioner’s arguments.  Petitioner cannot argue this ruling is prejudicial as the evidence is offered and urged by Petitioner.  CMS objects to my consideration of pages of P. Exs. 1, 2, 5, 6, 7, 15, and 17, arguing that the pages duplicate pages in CMS exhibits.  There is no rule of evidence or procedure applicable in this case that precludes a party from offering documents that duplicate documents offered by the opposing party.  Efforts to minimize the introduction of duplicative or cumulative evidence is really for the benefit of the fact finder.  I do not find overly burdensome any duplicates offered by Petitioner.  The CMS objections are overruled and P. Exs. 1 through 19 are admitted and considered as evidence.

II.  Discussion

A.  Applicable Law

Statutory and Regulatory Medicare Program Enforcement

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Act and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3  The

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Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, a CMP, appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  42 C.F.R. § 488.301.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10‑.28, 488.300-.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  CMS is authorized to impose a CMP on a per day or

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per instance basis.  In this case, CMS proposed a per day CMP.  When the surveys were conducted from March 10 through May 3, 2022, and the initial determination was issued on August 9, 2022, CMS was authorized to impose a per day CMP in the lower range of CMPs of $120 to $7,195 per day for noncompliance that did not pose immediate jeopardy and in the upper range of CMPs of $7,317 to $23,989 for noncompliance that posed immediate jeopardy.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2022).  The higher range is not subject to consideration in this case as there is no allegation of immediate jeopardy.

The Act and regulations make a hearing before an ALJ available to a SNF against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2004).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

Petitioner was notified in this case that it was ineligible to conduct a NATCEP for two years beginning on March 10, 2022.  CMS Ex. 12 at 4.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination).  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial

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extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $11,995 (45 C.F.R. § 102.3 (Table) (2022)); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  The amount of the CMP imposed and the fact an extended or partial extended survey was conducted triggered Petitioner’s ineligibility to conduct a NATCEP through March 10, 2024.  CMS Ex. 12 at 4.  Petitioner did not have a NATCEP.  P. Br. at 2.

Burden of Proof, Burden of Production, and Quantum of Evidence

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.4  Rather, the Board has

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long held that the petitioner, i.e., the nongovernmental party affected by CMS action imposing an enforcement remedy, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff’d, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance, which is determined without consideration or weighing of Petitioner’s evidence.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7-8, 15 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.”  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  Black’s Law Dictionary 1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether Petitioner has the burden of persuasion even if CMS failed to make a prima facie showing on each element of its case.  It is also unclear from prior Board decisions whether CMS can make a prima facie showing with mere allegations or a scintilla of evidence.  The Board has indicated that CMS may make a prima facie showing of noncompliance based solely upon the factual allegations of the statement of deficiencies (SOD) that “are specific, undisputed, and not inherently unreliable.”  Evergreene, DAB No. 2069 at 15.  In this case, I

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conclude CMS has made its prima facie showings by a preponderance of the evidence as to each instance of noncompliance I find based on the evidence before me.

B.  Issues

Whether there is a basis for the imposition of an enforcement remedy; and

Whether the remedies proposed are reasonable.

C.  Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence given the greatest weight in my decision-making.5  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

The following tables list the noncompliance cited by the survey and investigations of Petitioner.

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MARCH 2022 SURVEY -- CMS EX. 2

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MARCH 2022 SURVEY -- CMS EX. 2

APRIL 2022 SURVEY -- CMS EX. 3

MAY 2022 SURVEY -- CMS EX. 4

CMS seeks to impose enforcement remedies for the period January 29 through May 19, 2022.  The initial issue is whether Petitioner was in noncompliance with program participation requirements at least as early as January 19, 2022, continuing throughout the entire period ending on May 19, 2022.  As the above tables show, the state agency found that all noncompliance cited by the March 10, 2022 survey was corrected by April 4, 2022.  All noncompliance cited by the survey completed on April 19, 2022 was corrected by May 5, 2022.  All noncompliance cited by the survey completed on May 3, 2022, was corrected by May 20, 2022, the date on which Petitioner returned to substantial compliance with program participation requirements.

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Petitioner challenged all allegations of noncompliance and the reasonableness of the enforcement remedies in its request for hearing.  RFH at 1.  But in briefing following the waiver of oral hearing, Petitioner elected to address only the allegations of noncompliance Petitioner assumed had the greatest impact on the amount of the CMP.8   Petitioner’s goal was reassessment of the CMP amount, ideally with a reduction in that amount.  P. Br. at 1, 3-4; P. Reply at 2-3.  First addressed in this decision are five allegations of noncompliance specifically briefed by Petitioner followed by discussion of the nine allegations of noncompliance not specifically addressed by Petitioner in briefing.  The allegations of noncompliance specifically addressed by Petitioner are Tags F686, which was cited by both the March and April 2022 surveys; F841 and F882 from the March 10, 2022 survey; and Tags F692 and F760 from the May 3, 2022 complaint investigation.  P. Br. at 4-10, 10-13, 13-15, 15-25; P. Reply at 3-7.

Based on the following discussion of facts and the analysis for each allegation of noncompliance, I conclude that Petitioner was not in substantial compliance with program participation requirements for the entire period of January 29 through May 19, 2022 – the period for which CMS proposed enforcement remedies.

1.  Petitioner violated 42 C.F.R. § 483.25(b)(1) (Tag F686) – March and April 2022 surveys.

2.  The violations of 42 C.F.R. § 483.25(b)(1) posed a risk for more than minimal harm to Residents 28 and 5 and caused actual harm to Resident 28 and 5.

3.  Petitioner has not shown by a preponderance of the evidence that it was in substantial compliance with the participation requirements established by 42 C.F.R. § 483.25(b)(1).

4.  Petitioner has not shown by a preponderance of the evidence that it corrected the noncompliance prior to May 5, 2022.

The regulation provides:

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Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents. Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices, including but not limited to the following:

* * * *

(b) Skin integrity--(1) Pressure ulcers. Based on the comprehensive assessment of a resident, the facility must ensure that—

(i) A resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable; and

(ii) A resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.

42 C.F.R. § 483.25(b)(1).

The surveyors cited examples of four residents as evidence of noncompliance during the March 10, 2022 survey and six residents during the survey that ended on April 19, 2022.  The surveyors alleged in the SOD for the March 10, 2022 survey that all four residents suffered actual harm.  CMS Ex. 2 at 11.  The surveyors alleged in the SOD for the survey ended on April 19, 2022, that the regulatory violation posed a risk for more than minimal harm for six residents, without actual harm or immediate jeopardy.  CMS Ex. 3 at 10-18.

The example of only one resident from each survey is sufficient to establish noncompliance that is a basis for the imposition of an enforcement remedy from January 29 through May 5, 2022.  It is not necessary to consider whether there are more examples to establish whether the violation was isolated, constituted a pattern, or was widespread because, according to prior decisions of the Board interpreting 42 C.F.R. § 498.3(b)(14)(i), scope and severity is not reviewable in this forum because there is no alleged immediate jeopardy that is cited as justification for imposing a CMP in the higher range authorized under the regulations.  See, e.g., Ridge Terrace, DAB No. 1834; Koester Pavilion, DAB No. 1750.  Further, as Petitioner concedes, it had no NATCEP program.

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P. Br. at 2.  Because Petitioner did not lose approval of a NATCEP based on a finding of substandard quality of care, under 42 C.F.R. § 498.3(b)(14)(ii) there is no right for Petitioner to challenge or receive review of the scope and severity determination to attempt to have the substandard quality of care finding overturned.

a.  Findings of Fact

The surveyors cited the examples of Residents 28, 36, 55, and 133 under Tag F686 in the SOD for the survey that ended March 10, 2022.  CMS Ex. 2 at 11.  Residents 1, 2, 3, 5, 6, and 12 were cited as examples by the surveyors in the SOD for the survey that concluded on April 19, 2022.  CMS Ex. 3 at 11.  The examples of Resident 28 from the March 2022 survey and Resident 5 from the April 2022 survey are sufficient to show the noncompliance under Tag F686.

(i)  Findings of Fact – CMS Policies

CMS adopted in the SOM as a matter of policy definitions related to the prevention and treatment of pressure ulcers that are applied by surveyors in conducting surveys.  The CMS policies do not have the force and effect of statute or regulations but are proven as fact based on evidence of the policies admitted as CMS Ex. 1.  The following definitions may be helpful to the reader.

A pressure ulcer (sometimes referred to as a pressure sore, decubitus ulcer, or bed sore) or pressure injury is a localized injury to skin or underlying soft tissue often over a bony prominence or due to the use of a medical or other device.  CMS distinguishes between a pressure injury, which presents as intact skin and may be painful, and a pressure ulcer which presents as an open ulcer that may be painful.  The injury occurs due to intense or prolonged pressure or pressure in combination with shear.  Skin temperature, moisture, nutrition, blood circulation (perfusion), co-morbidities, and the condition of the soft tissue may all impact ulcer formation and healing.

Friction is the mechanical force exerted on skin that is dragged across any surface.  Shearing results when layers of the skin rub against each other or the underlying tissue rubs against the skin resulting in tissue damage.  Friction and shearing are not primary causes of pressure ulcers, but they are considered contributing factors.

Eschar, which sometimes covers part or an entire pressure ulcer, is a thick, leathery, black or brown colored, necrotic or devitalized tissue that has lost its normal physical properties and biological activity, and it may be loose or firmly adhered to a wound.

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Debridement is the removal of dead tissue and foreign matter from a wound to permit and improve healing.

According to CMS an avoidable pressure ulcer develops when a facility fails to do one or more of the following:  evaluate the resident’s clinical condition and risk factors; define and implement interventions consistent with the residents, needs, goals, and professional standards to prevent ulcers; fails to monitor and evaluate the effectiveness of interventions; or revises the interventions that are not effective.

According to CMS a pressure ulcer may be unavoidable – the term used in the regulation – if a resident develops a pressure ulcer/injury despite the fact the facility evaluated the resident’s clinical condition and risk factors; defined and implemented interventions consistent with the resident’s needs, goals, and professional standards of practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate.

CMS describes four stages for pressure ulcers/injuries:  a stage 1 pressure injury is a non-blanchable redness of the skin; a stage 2 pressure ulcer is a partial-thickness loss of skin with exposed dermis; a stage 3 pressure ulcer is a full thickness skin loss with subcutaneous fat visible; and a stage 4 pressure ulcer is a full-thickness skin loss and tissue loss with fascia, muscle, tendon, ligament, cartilage, or bone visible.

CMS Ex. 1 at 25-28 (SOM app. PP, Tag F686 (rev. 173, eff. Nov. 28, 2017)).

The CMS definitions are unchallenged in this case.

(ii)  Findings of Fact Related to Petitioner’s Wound and Pressure Ulcer Policies

Petitioner’s policies regarding pressure ulcers and wounds were placed in evidence by CMS as CMS Exs. 33-42, 64-65.  Petitioner’s pressure ulcer treatment and management policy established nine guidelines for residents with pressure ulcers.  The guidelines required, among other things:

Residents with pressure ulcers were to have a physician’s order for treatment;

The wound was to be described each week;

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A licensed nurse was to document treatment on the treatment administration record (TAR)9;

The plan of care was supposed to include the use of pressure relief, turning and repositioning, additional nutritional measures, and need for assistance with mobility and range of motion; and

The treating physician was to be notified if an assessment of the ulcer indicated a lack of progress in healing.

CMS Ex. 34.

According to Petitioner’s pressure ulcer prevention protocol all resident beds were to have pressure reducing mattresses unless a pressure relieving mattress was required.  CMS Ex. 33.

Petitioner’s skin assessment policy and procedure required that all residents at high risk for developing pressure ulcers were to have a head-to-toe skin assessment by a licensed nurse or certified nursing assistant (CNA) daily that was documented in the daily skin assessment record or the TAR.  CMS Ex. 36.

Petitioner’s pressure ulcer treatment and management policy provided that residents with pressure ulcers were at high risk.  CMS Ex. 34.

Petitioner’s wound assessment policy and procedure required that wound and dressing status were to be monitored daily using the daily skin assessment/wound status sheet.  A complete wound assessment was to be done weekly by a licensed nurse for all wounds, ulcers, and any other problem with skin integrity and documented on the wound assessment flow sheet.  CMS Exs. 37, 65.

Petitioner’s policy for the management of wounds defines a pressure ulcer as “any lesion caused by unrelieved pressure that results in damage to the underlying tissue(s). . . . Treatment of the ulcer, dietary management, management of tissue loads and interventions to improve tissue tolerance to pressure, friction, and shearing forces are critical components.”  CMS Exs. 42 at 2, 64 at 2.  The policy provides that Petitioner’s policy is to manage tissue load and possible damage from pressure, friction, or shearing

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forces through appropriate positioning practices, positioning devices, and support surfaces.  CMS Exs. 42 at 3, 64 at 3.

(iii)  Findings of Fact Related to Resident 28 – March Survey

Resident 28 was admitted to Petitioner’s facility on June 9, 2021.  Resident 28’s medical records placed in evidence do not show that she had a pressure ulcer at admission to Petitioner.  CMS Ex. 15 at 7, 10.

On January 11, 2022, a wound specialty physician examined Resident 28 and measured a stage 3 pressure ulcer on her sacrum.  The doctor measured the wound as 3 by 10 by 0.2 centimeters (cm) and reported observing light serous drainage.  The doctor debrided the wound, removing necrotic tissue until healthy bleeding tissue was observed.  The doctor’s plan of care had the goal of healing the wound in about 49 days and required off-loading the wound; repositioning as required by facility policy; and daily dressing changes.  Follow-up by a wound specialist in 8 to 14 days was also ordered by the doctor.  CMS Ex. 15 at 9, 11-13; P. Ex. 6 at 2.

Petitioner’s wound summary report dated March 7, 2022, shows that Resident 28 had a stage 3 pressure ulcer.  The wound summary report incorrectly states the wound was on Resident 28’s left buttock rather than her sacrum; the wound was not present on admission; it was first identified on December 15, 2021; the wound was initially 1 by 2 cm; and the wound had been present for 83 days.  The wound summary report indicated that during the most recent observation of the wound on January 18, 2022, the wound measured 3 by 10 by 0.2 cm and was described as improving.  CMS Ex. 15 at 10.

The wound specialty physician saw Resident 28 on March 15, 2022, after the survey that ended on March 10, 2022.  He recorded that the ulcer was 3 by 3 by 0.2 cm and still a stage 3 ulcer with light serous drainage.  He changed the care plan to changing dressings three times per week, off-loading the wound and repositioning per facility protocol.  CMS Ex. 15 at 8; P. Ex. 6 at 1.

Petitioner’s MARs for Resident 28 list the order for daily dressing changes for the pressure ulcer.  The January 1 through 31, 2022, MAR does not show that the dressing changes were done on January 13, 14, 17, 21, 26, 28, or 31, 2022, based on the absence of staff initials on those days showing they did the dressing changes.  CMS Ex. 15 at 2.  The MAR for February 1 through 28, 2022, does not show that dressing changes were done on February 1, 4, 6, 7, 8, 9, 10, 12, 13, 15, 19, 20, and 23, 2022.  CMS Ex. 15 at 4.  The MAR for March 1 through 9, 2022 does not show dressing changes on March 5, 6, and 7, 2022.  CMS Ex. 1 at 6.

Petitioner presented no evidence that Resident 28 was turned or repositioned on a regular schedule or what efforts were made to keep weight off the stage 3 ulcer on Resident 28’s

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sacrum.  The wound specialty physician’s care plan for Resident 28, required that Resident 28 be repositioned according to Petitioner’s policy.  CMS Ex. 6 at 8-9, 12-13; P. Ex. 6 at 1-2.  But none of Petitioner’s policies in evidence related to pressure ulcers or other wounds specify how and when residents with pressure ulcers or at risk for ulcers should be repositioned to help prevent future ulcers or heal existing ulcers.  The policies also do not give specific directions for how to off-load a pressure ulcer.  CMS Exs. 33-42, 64-65.  Therefore, the wound specialty physician’s direction to reposition according to Petitioner’s policy (CMS Ex. 6 at 8-9, 12-13; P. Ex. 6 at 1-2) was completely ineffective without clarification because staff could not know what action the order required.

There are several requirements of Petitioner’s policies and procedures for preventing and healing pressure ulcers that are not shown to have been done or used for Resident 28.  There is no evidence before me documenting repositioning of Resident 28 or off-loading weight from her pressure ulcer.  There is no evidence before me of weekly wound assessment by a licensed nurse with a description of the wound as required by Petitioner’s policy.  There is no evidence that Resident 28 had either a pressure reducing or pressure relieving mattress as required by Petitioner’s policy.  There is no evidence of dietary management.  There is no evidence of the use of positioning devices.  The evidence shows that dressing changes ordered by the wound specialty physician were not documented to show they were done seven times in January 2022, 13 times in February 2022, and three times in March 2022.  CMS Ex. 15 at 2, 4, 6.

CMS placed in evidence the declaration of Surveyor Frederick Ramos, RN, who also has a wound care certification and is a licensed nursing home administrator.  Surveyor Ramos participated in the March 2022 survey, and he drafted the findings of the SOD under Tag F686, specifically the example of Resident 28.  CMS Ex. 78 at 1.  Petitioner waived the right to cross-examine Surveyor Ramos by waiving an oral hearing.  Surveyor Ramos found and concluded in the SOD and stated in his declaration that Petitioner did not comply with the requirement to provide Resident 28 necessary treatment and services consistent with professional standards of practice to prevent and promote the healing of Resident 28’s pressure ulcer.  He specifically noted that Petitioner failed to follow the orders of the wound specialty physician.  CMS Ex. 78 at 2 ¶ 9.  He opined that it is a standard of practice for a healthcare professional to sign the MAR each time treatment is administered.  CMS Ex. 78 at 3 ¶ K.  He also opined it is a professional standard of practice to provide treatment as ordered by a physician and failure to do so can cause worsening of a pressure ulcer.  CMS Ex. 78 at 3 ¶ L.  Surveyor Ramos testified that on March 9, 2022, he observed a wound nurse provide wound care for Resident 28’s sacral ulcer, which then measured 4.5 cm by 15 cm and the depth could not be measured due to the presence of necrotic tissue.  Surveyor Ramos testified that the wound nurse told him that the ulcer had increased in size because Resident 28 was not being turned or repositioned.  He testified it is standard of practice to turn and reposition a resident with a pressure ulcer every two hours to take pressure off the ulcer so there is an adequate

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supply of blood.  CMS Ex. 78 at 4 ¶¶ O-R.  He concluded that Petitioner failed to comply with 42 C.F.R. § 483.25(b)(1)(ii).  CMS Ex. 78 at 5 ¶¶ S, X.  The surveyors concluded that the residents in the examples cited under Tag F686 suffered actual harm due to Petitioner’s noncompliance.  CMS Ex. 2 at 11.

(iv)  Findings of Fact Related to Resident 5 – April Survey

The surveyors alleged in the SOD for the survey completed on April 19, 2022, that Petitioner violated 42 C.F.R. § 483.25(b)(1) because Petitioner failed to accurately assess and provide treatment for Resident 5’s existing pressure ulcer and failed to follow its wound prevention protocol because staff did not conduct a comprehensive wound assessment.  CMS Ex. 3 at 11.

Resident 5 was admitted to Petitioner on February 25, 2022, and discharged on March 11, 2022.  Her diagnoses at admission included an unstageable pressure ulcer in the sacral region.  CMS Ex. 50 at 71-72.  Resident 5 transferred to Petitioner from another facility.  A transfer report from the other facility shows that Resident 5 was assessed on January 10, 2022, with pressure injuries on her right neck and her coccyx.  CMS Ex. 50 at 3.  Resident 5 was assessed before the transfer as having a poor prognosis with meaningful recovery unlikely and she was considered appropriate for do not resuscitate status and palliative care.  CMS Ex. 50 at 4.  A progress note dated February 26, 2022, shows that Resident 5 was seen by wound care and that wounds were noted.  CMS Ex. 50 at 74.

On March 3, 2022, the wound specialty physician evaluated Resident 5’s pressure ulcer.  The physician found that Resident 5 had an unstageable full thickness pressure ulcer on her sacrum that measured 7.5 cm by 6.5 cm, the depth could not be determined, and there was moderate drainage.  He noted that the resident had the wound on admission.  The physician completed a surgical debridement of dead tissue.  He ordered dressing changes three times per week for 30 days, off-loading the wound, and repositioning according to Petitioner’s protocol.  CMS Ex. 50 at 77-79, 81.

Resident 5 had a care plan for March 1 through 14, 2022, that indicated she was at risk for skin breakdown for multiple reasons.  Interventions listed included avoiding shearing of the resident’s skin during positioning, transferring, and turning; continuing to assess pressure ulcer risks; keeping her call light in reach; obtaining laboratory tests as ordered and reporting the results to the physician; a pressure relieving mattress; providing ordered diet; providing incontinence care after each incontinent episode; reporting any signs of skin breakdown; turning and repositioning frequently but with no specification of the frequency; using moisture barrier products on the perineal area; and conducting a weekly skin assessment per policy.  CMS Ex. 50 at 100-02.

Resident 5 had a care plan in effect from March 7 through 14, 2022, that assessed that she was at risk for skin irritation or breakdown due to incontinence.  The care plan required

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staff to check skin integrity per facility protocol, provide incontinence care after each incontinent episode, avoid friction to skin, report any signs of skin breakdown, and use moisture barrier products on the resident’s perineal area.  CMS Ex. 50 at 89-90.

A March 8, 2022 progress note indicates that the nurse, who was rounding with the wound care team, observed Resident 5’s wound which she described as pink with no drainage.  CMS Ex. 50 at 75.

The wound physician saw Resident 5 again on March 10, 2022.  He measured the wound as 9.5 cm by 8 cm and the depth could not be determined.  He debrided the wound again.  He continued his orders for dressing changes three times per week, off-loading the wound, and repositioning according to facility policy.  He also ordered a dietary supplement and vitamins.  CMS Ex. 50 at 76, 80, 82-83.

The wound care physician’s notes for March 3 and 10, 2022, show that Resident 5’s wound increased in size.  CMS Ex. 50 at 77-79, 82.  I find that the increased size of the wound makes it more likely than not that Resident 5 suffered actual harm in the form of possibly increased discomfort, risk for infection, need for debridement which could be painful, or a combination of symptoms.

Forms for CNAs to note any skin problems while administering a resident’s bath were completed on February 28, and March 3, 7, and 9, 2022, without any notation that Resident 5 had a pressure ulcer.  CMS Ex. 50 at 84-87.  MARs for Resident 5 from February 25 to March 11, 2022, are in evidence as CMS Ex. 50 at 6-54.  The MAR recording pressure ulcer treatment and dressing changes shows dressing changes and treatment were done only on March 9, 2022 at 9:00 a.m., and not three days per week as ordered by the wound specialty physician.  CMS Ex. 50 at 54.  No daily checks of skin integrity, incontinent care including use of moisture barrier cream, efforts to avoid shearing and friction, and reporting are recorded on the MAR, contrary to the requirements of the resident’s care plans and physician orders.  CMS Ex. 50 at 52, 89-90, 100-02.  The MARs do not list the wound specialist’s orders for a turning or repositioning schedule and a procedure or the use of any device for off-loading the wound.  CMS Ex. 50 at 76, 80, 82-83.  None of Petitioner’s policies in evidence related to pressure ulcers or other wounds specify how and when residents with pressure ulcers or at risk for ulcers should be repositioned to help prevent future ulcers or heal existing ulcers.  The policies also do not give specific directions for how to off-load a pressure ulcer.  CMS Exs. 33-42, 64-65.  Therefore, the wound specialty physician’s orders to off-load the wound and reposition according to Petitioner’s policy (CMS Ex. 50 at 76-79, 80-83) were completely ineffective without clarification because staff could not know what actions the orders required.

CMS provided the declaration of Surveyor Karyn Rundle, RN who participated in the complaint investigations completed April 19 and May 3, 2022.  CMS Ex. 86.  She opined

that it is a professional standard of care to provide treatments as prescribed by a resident’s physician.  She concluded based on her investigation that Petitioner failed to deliver for Resident 5 care and treatment ordered by her physician, in accordance with the resident’s care plan, and in accordance with Petitioner’s policies.  CMS Ex. 86 at 8-10.

The surveyors opined that the noncompliance under Tag F686 from the April 2022 investigation posed a risk for more than minimal harm without actual harm or immediate jeopardy.  CMS Ex. 3 at 10.  Surveyor Rundle opined that failure to provide care and treatment for ulcers as ordered may delay healing, increase the risk for infection, and lead to complications.  CMS Ex. 86 at 9 ¶ J.  She did not state that she found continuing pain, delayed healing, infection, or complications which would support a finding of actual harm.  Therefore, I do not disturb the surveyors’ conclusion that the noncompliance under Tag F686 posed a risk for more than minimal harm with no actual harm.  Nevertheless, for purposes of assessing the reasonableness of the enforcement remedies in this case, I find it more likely than not that Resident 5 suffered actual harm in the form of increased discomfort, risk for infection, need for debridement which could be painful, or a combination of symptoms.

b.  Analysis

Under the quality of care regulations, Petitioner must ensure that:

A resident without a pressure ulcer does not develop one by delivering care consistent with professional standards of practice, unless development of an ulcer is unavoidable due to the resident’s condition; and

A resident with a pressure ulcer received treatment and services consistent with professional standards of practice to promote healing, prevent infection, and prevent new ulcers from developing.

42 C.F.R. § 483.25(b)(1).  If Petitioner fails to meet the regulatory requirements and the regulatory violation poses a risk for more than minimal harm, there is noncompliance under Tag F686.

Application of the regulation is well-established by the decisions of various appellate panels of the Board.  In Rae-Ann Geneva Nursing Home, DAB No. 2461 (2012), the Board reviewed principles recognized in prior decisions of the Board:

The facility must go beyond what seems reasonable and always furnish care and services necessary to prevent new sores, unless clinically avoidable and to treat existing sores;

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A prima facie case of noncompliance with the regulation exists when the evidence shows that a resident who is admitted with no pressure sores develops a sore in the facility;

When it is shown that a resident develops a sore in the facility, the burden is on the facility to show that development of the sore was clinically unavoidable;

To show that development of a pressure sore was clinically unavoidable, the facility must show it provided all the care and services needed to prevent development of a pressure sore, but a sore developed anyway because it was clinically unavoidable;

Clinically unavoidable means development of the sore was not only unsurprising given the condition of the resident, but it was unpreventable despite appropriate measures implemented considering the clinical risks; and

A facility does not meet its burden to show that a pressure sore or ulcer was clinically unavoidable by a showing that a resident was at increased risk for developing pressure sores.

Id. at 6-7.10

The evidence presented by CMS establishes a prima facie showing of noncompliance as there was a violation of 42 C.F.R. § 483.25(b)(1)(i) based on the example of Resident 28 and a violation of 42 C.F.R. § 483.25(b)(1)(ii) based on the example of Resident 5 and both violations posed a risk for more than minimal harm.

(i) Resident 28

There is no dispute that Resident 28 was admitted to Petitioner with no pressure ulcer.  Because she subsequently developed a pressure ulcer while a resident of Petitioner, there is a prima facie showing of a violation of 42 C.F.R. § 483.25(b)(1)(i).  Therefore, the burden is on Petitioner to show that Resident 28’s development of a pressure sore was unavoidable.  Rae-Ann Geneva, DAB No. 2461 at 5-6 (a prima facie case of

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noncompliance exists if evidence shows a resident admitted with no pressure sore and a pressure sore develops, then the burden shifts to the facility to show it was unavoidable).  The Board has held that a prima facie showing based on the development of a pressure sore may only be overcome by “showing that [the facility] provided all the care and services needed to prevent pressure sores but they developed anyway because they were clinically unavoidable.”  Id. at 7.

“Clinically unavoidable” in this context “means not just unsurprising given the clinical condition of the resident, but incapable of prevention despite appropriate measures taken in light of the clinical risks.”  Harmony Court, DAB No. 1968, at 11 (2005), aff’d, Harmony Court v. Leavitt, 188 F. App’x 438 (6th Cir. 2006). A facility “cannot meet its burden of proof on the issue of whether a pressure sore is unavoidable merely by establishing that the resident’s clinical condition heightens the risk that pressure sores will develop.” Id., quoting Ivy Woods Health Care and Rehab. Ctr., DAB No. 1933, at 9 (2004), aff’d, Ivy Woods Health Care and Rehab. Ctr. v. Thompson, 156 F. App’x 775 (6th Cir. 2005).

Rae-Ann Geneva, DAB No. 2461 at 7.

Petitioner does not specifically argue that Resident 28’s development of a pressure ulcer was unavoidable.  Rather, Petitioner argues that it provided appropriate care for Resident 28 focusing on care provided after the pressure ulcer developed.  Petitioner correctly notes that the evidence shows that Resident 28’s pressure ulcer improved.  P. Br. at 8; CMS Ex. 15 at 8-9, 11-13; P. Ex. 6 at 1-2.  Petitioner argues generally that it “cares for highly complex residents with many co-morbidities who are admitted with or at risk for pressure injury.”  P. Br. at 10; P. Reply at 3.  Petitioner argues that the examples cited by the March 2022 survey under Tag F686 with actual harm due to the development of pressure ulcers involved residents for whom the development of pressure ulcers was unavoidable.  P. Br. at 10; P. Reply at 3.

I conclude Petitioner failed to rebut the CMS prima facie showing in the case of Resident 28.  Resident 28 was admitted to Petitioner with no pressure ulcer on June 9, 2021.  CMS Ex. 15 at 7, 10.  On January 11, 2022, seven months after her admission, a wound specialty physician confirmed that Resident 28 had developed a stage 3 pressure ulcer on her sacrum.  CMS Ex. 15 at 9, 11-13; P. Ex. 6 at 2.  Petitioner does not deny these facts.  Petitioner does not argue that the development of the pressure ulcer was unavoidable.  Petitioner does not dispute that as of March 15, 2022, there was apparent improvement in Resident 28’s pressure ulcer as reflected by its decreased size.  CMS Ex. 15 at 8; P. Ex. 6 at 1.  I find that the fact Resident 28’s pressure ulcer was improving is very good evidence that the pressure ulcer was not unavoidable.  Rae-Ann Geneva, DAB No. 2461

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at 13.  Accordingly, I conclude that Petitioner has failed to show that Resident 28’s development of a pressure ulcer was unavoidable.

Petitioner’s violation of 42 C.F.R. § 483.25(b)(i) by failing to prevent the development of Resident 28’s pressure sore and its failure to establish the affirmative defense that the development was unavoidable establishes the violation of 42 C.F.R. § 483.25(b).  There can be no dispute that the development of a pressure ulcer is actual harm.  Therefore, the development of a pressure ulcer amounts to noncompliance.

Having found noncompliance with 42 C.F.R. § 483.25(b)(1)(i), it is not necessary to address Petitioner’s arguments that it provided Petitioner necessary care and services to treat the pressure sore once it developed -- the requirement of 42 C.F.R. § 483.25(b)(1)(ii).  Nevertheless, in the interest of thoroughness, I share my thoughts and observations for the benefit of Petitioner and the Board on any subsequent appeal.  The requirement of 42 C.F.R. § 483.25(b)(1)(ii) is that when a resident has a pressure ulcer, the resident must be provided treatment and services consistent with professional standards of practice to promote healing, prevent infection, and prevent new ulcers from developing.  The Board has held that the requirement for treating an existing pressure ulcer is that a facility must take action to promote healing; a pressure sore that persists without improvement is not healing; and a facility bears the burden to show if healing did not occur it is because the failure to heal is clinically unavoidable.  CMS meets its burden to make a prima facie showing of a violation of 42 C.F.R. § 483.25(b)(1)(ii) by showing that a facility failed to follow physician orders for treatment of a pressure ulcer.  Embassy Health Care Ctr., DAB No. 2299 at 3-5 (2010).

Petitioner failed to meet the participation requirement of 42 C.F.R. § 483.25(b)(1)(ii) because it failed to follow physician orders, including failing to obtain clarification of those orders absent specific guidance in Petitioner’s own policies regarding turning, repositioning, and off-loading weight from Resident 28’s pressure ulcer.

Surveyor Ramos testified that following physician orders is standard of care.  CMS Ex. 78 at 3 ¶ I.  The surveyor’s opinion is not disputed by Petitioner.

Because Petitioner cannot show it followed physician orders, it cannot show it delivered the quality of care required by 42 C.F.R. § 493.25(b)(1)(ii).  The wound specialty physician ordered on January 11, 2022, that Resident 28 be repositioned as required by facility policy, off-loading the wound, and daily dressing changes.  CMS Ex. 15 at 9, 11-13; P. Ex. 6 at 2.  Petitioner’s MARs for Resident 28 for January, February, and March 2022 do not show that Resident 28’s dressing was changed on 23 days.  CMS Ex. 15 at 2, 4, 6.  No evidence has presented that Petitioner’s staff took any action to off-load Resident 28’s wound or turn or reposition Resident 28 regularly.  Petitioner waived an oral hearing and the presentation of oral testimony and presented no declarations of staff to show off-loading or repositioning was done.  Therefore, Petitioner has failed to meet

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its burden to rebut the CMS prima facie showing by presenting evidence a staff accomplished daily dressing changes, off-loaded Resident 28’s wound, and repositioned the resident regularly to establish a defense that the failure to heal the resident’s wound was clinically unavoidable or that Petitioner was otherwise in substantial compliance with 42 C.F.R. § 483.25(b)(1).

(ii) Resident 5

Resident 5 had an unstageable pressure ulcer on her sacrum or coccyx when she was admitted to Petitioner on February 25, 2022.  CMS Ex. 50 at 3, 71-72.  She was seen by a wound specialty physician on March 3, 2022.  The physician ordered dressing changes three times per week, off-loading the wound, and repositioning according to Petitioner’s protocol.  CMS Ex. 50 at 77-79, 81.  The wound specialty physician saw Resident 5 again on March 10, 2022, and observed that her pressure ulcer had increased in size.  In addition to his prior orders, he ordered a dietary supplement and vitamins.  Petitioner adopted care plans for Resident 5.  Interventions listed included avoiding shearing of resident’s skin during positioning, transferring, and turning; continuing to assess pressure ulcer risks; keeping her call light in reach; obtaining laboratory tests as ordered and reporting the results to the physician; a pressure relieving mattress; providing ordered diet; providing incontinence care after each incontinent episode; reporting any signs of skin breakdown; turning and repositioning frequently but with no specification of the frequency; using moisture barrier products on the perineal area; and conducting a weekly skin assessment per policy.  CMS Ex. 50 at 89-90; 100-02.

Because Resident 5 had a pressure ulcer on admission, the applicable participation requirement is 42 C.F.R. § 483.25(b)(1)(ii), which was discussed in the immediately preceding example of Resident 28.  As in the example of Resident 28, Petitioner failed to meet the participation requirement of 42 C.F.R. § 483.25(b)(1)(ii) in the case of Resident 5 because it failed to follow physician orders, including failing to obtain clarification of those orders absent specific guidance in Petitioner’s own policies regarding turning, repositioning, and off-loading weight from Resident 5’s pressure ulcer.

MARs for Resident 5 from February 25 to March 11, 2022, are in evidence as CMS Ex. 50 at 6-54.  The MAR recording pressure ulcer treatment and dressing changes shows dressing changes and treatment were done only on March 9, 2022 at 9:00 a.m., and not three days per week as ordered by the wound specialty physician.  CMS Ex. 50 at 54.  No daily checks of skin integrity, incontinent care including use of moisture barrier cream, efforts to avoid shearing and friction, reporting, the administration of a dietary supplement or vitamins, are recorded on the MARs in evidence, contrary to the requirements of the resident’s care plans and physician orders.  CMS Ex. 50 at 52, 89-90, 100-02.  The MARs do not list the wound specialist’s orders for a turning or repositioning schedule and a procedure or the use of any device for off-loading the wound.  CMS Ex. 50 at 76, 80, 82-83.  None of Petitioner’s policies in evidence related

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to pressure ulcers or other wounds specify how and when residents with pressure ulcers or at risk for ulcers should be repositioned to help prevent future ulcers or heal existing ulcers.  The policies also do not give specific directions for how to off-load a pressure ulcer.  CMS Exs. 33-42, 64-65.  Therefore, the wound specialty physician’s orders to off-load the wound and reposition according to Petitioner’s policy (CMS Ex. 50 at 76-79, 80-83) were completely ineffective without clarification because staff could not know what actions the orders required.

Petitioner generally denies it was noncompliant under Tag F686.  P. Br. at 4.  However, Petitioner presents no specific argument or evidence with respect to Resident 5 and states that “the Facility is not providing comment regarding the specific citations written during [the April 19, 2022] inspection.”  P. Br. at 15.

I conclude that Petitioner has failed to meet its burden to rebut the CMS prima facie showing by presenting evidence it complied with physician orders or Resident 5’s care plans to establish a defense that the failure to heal the resident’s wound was clinically unavoidable or that Petitioner was otherwise in substantial compliance with 42 C.F.R. § 483.25(b)(1).

The state agency and CMS concluded that Petitioner completed correction of its noncompliance under Tag F686 effective May 5, 2022.  CMS Ex. 5 at 1-2.  Petitioner alleges there was no noncompliance under Tag F686, not that it returned to substantial compliance under Tag F686 before May 5, 2022, if I concluded that there was noncompliance.  P. Br. at 4-10; P. Reply at 3-4.  I conclude that noncompliance under Tag F686 existed from at least January 11 through May 4, 2022.

Petitioner argues that it should not be penalized for the state agency’s delay in conducting the revisit survey because it may have been found in substantial compliance earlier.  P. Br. at 15.  A facility has the right to challenge the CMS determination of the date that the facility returned to substantial compliance.  Taos Living Ctr., DAB No. 2293 at 16-18 (2009).  However, Petitioner bears the burden to show when it returned to substantial compliance, and not just substantial compliance with 42 C.F.R. § 483.25(b)(1) but all the alleged compliance.  Petitioner alleged in its plan of correction for the March 2022 survey that it corrected the noncompliance alleged under Tag F686 on April 4, 2022.  CMS Ex. 2 at 11.  Petitioner alleged in its plan of correction for the April 2022 survey that it corrected the noncompliance alleged under Tag F686 on May 5, 2022.  CMS Ex. 3 at 10.  The state agency and CMS accepted April 4, 2022 and May 5, 2022 as the dates Petitioner corrected its noncompliance with 42 C.F.R. § 483.25(b)(1).  CMS Ex. 5 at 1, 2.  Therefore, the date the revisit survey was conducted, had no impact upon the duration of the noncompliance cited under 42 C.F.R. § 483.25(b)(1).  The Board has consistently rejected claims by a facility that it returned to substantial compliance before the date it alleged in its plan of correction.  Libertyville Manor Rehab. & Healthcare Ctr., DAB No. 2849 at 14-15 (2018).  Further, Petitioner has not presented argument or evidence from

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which it can be determined it returned to substantial compliance with 42 C.F.R. § 483.25(b)(1) before May 5, 2022.  I conclude that Petitioner has failed to meet its burden to show by a preponderance of the evidence that it was in substantial compliance with the participation requirements at 42 C.F.R. § 483.25(b)(1) or that it returned to substantial compliance before May 5, 2022.11

5.  Petitioner violated 42 C.F.R. § 483.70(h)(2) (Tag F841) – March 2022 survey.

6.  The violation of 42 C.F.R. § 483.70(h)(2) posed a risk for more than minimal harm.

7.  Petitioner has not shown by a preponderance of the evidence that it was in substantial compliance with the participation requirements established by 42 C.F.R. § 483.70(h)(2).

8.  Petitioner has not shown by a preponderance of the evidence that it corrected the noncompliance prior to April 4, 2022.

The participation requirement established by 42 C.F.R. § 483.70(h) requires:

(h) Medical director.

(1) The facility must designate a physician to serve as medical director.

(2) The medical director is responsible for--

(i) Implementation of resident care policies; and

(ii) The coordination of medical care in the facility.

The surveyors allege that Petitioner “failed to coordinate medical care and resident care policies” with Petitioner’s medical director.  CMS Ex. 2 at 39.

a. Findings of Fact

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The surveyors list Sulwani Zharesh as Petitioner’s medical director during the survey that ended on March 10, 2022.  CMS Ex. 13 at 3.  Petitioner placed in evidence as P. Ex. 9 a document titled “Affidavit of Haresh Sawlani, MD” which lists the name of Petitioner’s medical director as Haresh Sawlani, but the affidavit is signed by Haresh Sawlain, MD.  P. Ex. 9.  Based on the fact that the affidavit was signed by Haresh Sawlain, MD, I find he was Petitioner’s medical director during the survey completed on March 10, 2022.

Surveyor Ramos testified in his declaration that he concluded that Petitioner did not comply with 42 C.F.R. § 483.70(h)(2), because Petitioner’s medical director did not fulfill the regulatory requirements to implement resident care policies and coordinate medical care at the facility.  CMS Ex. 78 at 5 ¶ 10.  Surveyor Ramos testified that his findings and conclusions were based on his March 8, 2022 telephone interview of Petitioner’s medical director.  His perception of the conversation was that Dr. Sawlain mentioned only his role as an attending physician and did not describe his roles and responsibilities as medical director; he indicated he did not participate in the development of facility policies; he stated that he attended Quality Assessment and Assurance Committee (QAA) meetings but he did not coordinate medical care except for his own patients; and he stated he did not get involved in wounds unless his patient had the wound.  CMS Ex. 78 at 6-7 ¶ 10E, G-K, N.

Dr. Sawlain testified in his affidavit that he has been Petitioner’s medical director for more than 20 years.  He testified that his duties as Petitioner’s medical director are specified in a written contract between him and the facility.  He does not provide medical care directly to patients in his role as medical director.  But he is the attending or primary care physician for several residents for whom he provides direct medical care.  Other residents receive direct medical care from their attending physicians.  He testified he did participate in routine QAA committee meetings where general care provided in the facility was discussed, including review of policy changes proposed by the facility, falls, infections, and wound care.  Dr. Sawlain testified that issues were discussed at the QAA meetings to determine whether there were quality assurance measures that required the attention of Petitioner’s administrator and board of directors.  He testified that facility staff and attending physicians knew that they could contact him with concerns and he would address those concerns with the proper person so they could be resolved timely.  He testified he was not involved in determining staffing levels.  P. Ex. 9 at 1-2 ¶¶ 1-3, 13-27, 29.  Dr. Sawlain testified that the surveyor (Surveyor Ramos) who conducted his interview on March 8, 2022, was rude, aggressive, and unprofessional and he reported the surveyor’s behavior to the state agency.  P. Ex. 9 at 1 ¶¶ 6-12, 31.  Surveyor Ramos stated in his declaration that contrary to the allegations he was not rude and aggressive but maintained his professionalism.  I need not resolve whether Surveyor Ramos was inappropriate or unprofessional.  Dr. Sawlain has provided his testimony in his affidavit without any interaction with Surveyor Ramos, and I find that affidavit is not subject to any intimidation, coercion, or any other inappropriate actions by state or federal agents, as the affidavit was placed in evidence by Petitioner.  I find that Dr. Sawlain does not

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address in his affidavit that he understood that under 42 C.F.R. § 483.70(h)(2) he was responsible to implement resident care policies of Petitioner and the coordination of medical care at Petitioner or how he fulfilled either requirement.  Dr. Sawlain’s contract with Petitioner as medical director is not in evidence.  There is also no policy of Petitioner or other document in evidence that addresses the duties of the medical director or how the medical director is expected to fulfill those duties.  Petitioner placed in evidence a form titled “Medical Director Time Record.”  The fields for data entry in the form are blank.  The form lists 11 specific tasks that could be performed by a medical director.  The form appears to be for use by a medical director to bill Petitioner for time working as a medical director.  P. Ex. 11.  There is no evidence that Dr. Sawlain was familiar with or used this form.  Petitioner presented evidence showing Dr. Sawlain attended Petitioner’s QAA committee meeting on November 21, 2021.  P. Ex. 10.

The SOM provides that a medical director’s responsibilities should include:

• Administrative decisions including recommending, developing and approving facility policies related to residents care.  Resident care includes the resident’s physical, mental and psychosocial well-being;
• Issues related to the coordination of medical care identified through the facility’s quality assessment and assurance committee and other activities related to the coordination of care;
• Organizing and coordinating physician services and services provided by other professionals as they relate to resident care;
• Participate in the Quality Assessment and Assurance (QAA) committee or assign a designee to represent him/her.  (Refer to F865);
• Ensuring the appropriateness and quality of medical care and medically related care;
• Assisting in the development of educational programs for facility staff and other professionals;
• Working with the facility’s clinical team to provide surveillance and develop policies to prevent the potential infection of residents.  Refer to Infection Control requirement at [42 C.F.R.] § 483.80;

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• Cooperating with facility staff to establish policies for assuring that the rights of individuals (residents, staff members, and community members) are respected;
• Supporting and promoting person-directed care such as the formation of advance directives, end-of-life care, and provisions that enhance resident decision making, including choice regarding medical care options;
• Identifying performance expectations and facilitating feedback to physicians and other health care practitioners regarding their performance and practices;
• Discussing and intervening (as appropriate) with a health care practitioner regarding medical care that is inconsistent with current standards of care; and
• Assisting in developing systems to monitor the performance of the health care practitioners including mechanisms for communicating and resolving issues related to medical care and ensuring that other licensed practitioners (e.g., nurse practitioners) who may perform physician-delegated tasks act within the regulatory requirements and within the scope of practice as defined by State law.

SOM app. PP F841 (rev. 173, eff. Nov. 28, 2017) (not included in CMS Ex. 1).  These requirements are not established by regulation and not enforceable as law.  Ind. Dep’t. of Pub. Welfare, 934 F.2d 853; Nw. Tissue Ctr., 1 F.3d 522.  But the SOM is a policy statement of CMS that is good evidence of what CMS officials think the regulation requires.

The state agency determined based on a revisit survey that Petitioner returned to compliance under Tag F841 on April 4, 2022, which is consistent with Petitioner’s plan of correction.  CMS Exs. 2 at 39, 5 at 2.

b. Analysis

Petitioner is required to have a medical director who is a physician and is responsible for implementation of resident care policies and the coordination of medical care in the facility.  42 C.F.R. § 483.70(h).  What the drafters intended that a medical director do to implement resident care policies and coordinate care is not explained in the regulation or in the regulatory history.  56 Fed. Reg. 48,826 (Sep. 26, 1991); 81 Fed. Reg. 68,688 (Oct. 4, 2016).

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In Western Care Management Corp., d/b/a Rehab Specialties Inn, DAB No. 1921, 2004 WL 1235824 (2004), the Board concluded that CMS failed to make a prima facie case of noncompliance under 42 C.F.R. § 483.75(i)(2) (a predecessor to 42 C.F.R. § 483.70(h)) based only upon the citation of other noncompliance during a survey.  The Board noted that CMS did not identify specific instances in which the medical director in that case failed to implement care policies or coordinate care when his or her coordination was necessary or required.  The Board allowed, however, that there might be a case in which the number and nature of deficiencies might support an inference that a medical director was not doing his or her job, but that was not the case before the Board.  Western Care Management Corp., 2004 WL 1235824 at *56-57.  The Board speculated in a footnote that noncompliance might exist if a medical director knows of a matter that by legal mandate, professional standards, or facility standards requires his involvement or the medical director fails to create, implement, enforce, or follow policies intended to ensure his involvement in the oversight or coordination of care in a facility.  Western Care Management Corp., 2004 WL 1235824 at *56 n.40.  This Board decision adds nothing to an understanding of what a medical director is required to do under 42 C.F.R. § 483.70(h).

In this case however, noncompliance was based on Dr. Sawlain’s inability or failure to articulate to Surveyor Ramos what his duties were and his assertions that his responsibilities as medical director were to attend QAA meetings and care for his own patients.  Surveyor Ramos concluded that there was noncompliance under Tag F841 based, at least in part, on the conclusion that Dr. Sawlain was not performing duties specified for a medical director by 42 C.F.R. § 483.70(h).  I conclude based on the evidence presented by CMS, i.e., the allegations of the SOD (CMS Ex. 2 at 39-41) and the declaration of Surveyor Ramos (CMS Ex. 78), that it was more likely than not that Petitioner did not require Dr. Sawlain to perform the duties of a medical director as required by 42 C.F.R. § 483.70(h).  I further conclude that Petitioner has failed to rebut the CMS prima facie showing of noncompliance under Tag F841.

Petitioner provided the testimony of Dr. Sawlain in the form of an affidavit.  Petitioner presented no other evidence such as Dr. Sawlain’s contract, time sheets, or similar documents, to show Dr. Sawlain’s duties as medical director or that he performed duties consistent with his duties as medical director under 42 C.F.R. § 483.70(h).  Therefore, the only evidence before me to permit a determination of whether Dr. Sawlain’s duties are as required by 42 C.F.R. § 483.70(h) and whether he performed those duties is 
Dr. Sawlain’s affidavit.  I conclude, based on my review of Dr. Sawlain’s affidavit that he did not describe his duties as including or that he performed duties consistent with the requirements of 42 C.F.R. § 483.70(h)(2), i.e., the implementation of resident care policies and the coordination of medical care in the facility, regardless of how the terms of those regulatory requirements may be defined.

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Petitioner argues that Dr. Sawlain is qualified to be a medical director, he participates in the QAA committee activities, and he is available around the clock for consultation.  P. Br. at 10; P. Reply at 4.  Petitioner does not assert that Dr. Sawlain was responsible for implementation of resident care policies or the coordination of medical care or provide any examples of how he did either.  Petitioner asserts that Dr. Sawlain had a contractual agreement that outlines his relationship with Petitioner and his duties.  P. Br. at 11; P. Reply at 4.  But Petitioner failed to place his contract in evidence.  I accept Petitioner’s assertion that as medical director Dr. Sawlain was not responsible to provide direct care to residents for whom he was not their primary care physician.  P. Br. at 11; P. Reply at 4.  Petitioner makes multiple assertions in its brief regarding Dr. Sawlain’s duties and his performance of duties that are unsupported by any evidence in the record except his attendance at QAA committee meetings (P. Ex. 10) and a blank time sheet (P. Ex. 11).  P. Br. at 11-13.  Petitioner’s assertions are not persuasive that Dr. Sawlain was responsible for implementation of resident care policies or the coordination of medical care at Petitioner as required by 42 C.F.R. § 483.70(h)(2).

Petitioner’s arguments could be construed to challenge the adequacy of the survey.  P. Br. at 12-13.  But the Board has previously concluded that the issue before an ALJ is whether the evidence presented supports CMS’s conclusion there was noncompliance upon which an enforcement remedy may be imposed.  Avon Nursing Home, DAB No. 2830 at 11 (2017).  To the extent CMS relies upon the testimony of surveyors or their recordings of the survey, evidence of their conduct may be considered when assessing the weight of the evidence.  Whether Surveyor Ramos was harsh or unprofessional, findings which I do not make, his testimony as to what Dr. Sawlain told him during the survey (CMS Ex. 78) is little different from Dr. Sawlain’s affidavit (P. Ex. 9), which supports the credibility of both their testimony.

Accordingly, I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.70(h).  The surveyors concluded that the violation posed a risk for more than minimal harm to Petitioner’s residents.  The surveyor’s conclusion is well founded given the important role for the medical director that protects residents through the implementation of policies and procedures and the coordination of their care.  Petitioner has not met its burden to show there was not a risk for more than minimal harm if 42 C.F.R. § 483.70(h) was violated.  Petitioner has not rebutted the CMS prima facie showing that it was not in substantial compliance with 42 C.F.R. § 483.70(h) from at least January 29 through April 4, 2022.  CMS Exs. 2 at 39, 5 at 2.

9.  Petitioner violated 42 C.F.R. § 483.80(b)(4) (Tag F882) – March 2022 survey.

10.  The violation of 42 C.F.R. § 483.80(b)(4) posed a risk for more than minimal harm.

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11.  Petitioner has not shown by a preponderance of the evidence that it was in substantial compliance with the participation requirements established by 42 C.F.R. § 483.80(b)(4).

12.  Petitioner has not shown by a preponderance of the evidence that it corrected the noncompliance prior to April 4, 2022.

The regulation requires:

(b) Infection preventionist.  The facility must designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility’s IPCP [Infection Prevention and Control Program].  The IP must:

(1) Have primary professional training in nursing, medical technology, microbiology, epidemiology, or other related field;

(2) Be qualified by education, training, experience or 
certification;

(3) Work at least part-time at the facility; and

(4) Have completed specialized training in infection prevention and control.

42 C.F.R. § 483.80(b).  The surveyors alleged that Petitioner violated 42 C.F.R. § 483.80(b) and (c)12 because Petitioner did not have a “certified infection preventionist” overseeing its infection control program.  CMS Ex. 2 at 42.

a. Findings of Fact

On September 27, 2021, Petitioner hired a registered nurse as its new infection preventionist (IP) or infection control nurse.  She resigned and terminated her employment with Petitioner on January 6, 2022.  P. Exs. 12, 13; P. Br. at 13.

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Petitioner concedes that its director of nursing (DON) assumed responsibility as Petitioner’s IP because no qualified candidate could be hired.  Petitioner also concedes that at the time of the March 2022 survey, the DON had started but not yet completed the Centers for Disease Control and Prevention (CDC) nursing home infection training program.  P. Br. at 14.

Surveyor Lauren Harris, who participated in and was the survey team coordinator for the March 2022 survey, opined in her declaration that Petitioner violated 42 C.F.R. § 483.80(b)(4) because the DON who was covering IP duties had not completed specialized training in infection prevention and control prior to assuming those duties.  CMS Ex. 80 at 1 ¶ 3, 10 ¶ 14J.  She opined that the CDC’s free on-line course would have been sufficient to meet the training requirement.  CMS Ex. 80 at 10 ¶ 14E.  Surveyor Harris testified that DON admitted she had not completed the training and that there was no other IP in the facility.  CMS Ex. 80 at 10 ¶ 14G.  Surveyor Harris testified that she was the primary author of Tag F882 in the SOD.  CMS Ex. 80 at 2 ¶ 7.

The surveyors found that the violation of 42 C.F.R. § 483.80(b) posed a risk for more than minimal harm.  CMS Ex. 2 at 41.

Petitioner stated in its plan of correction that the noncompliance was corrected as of April 4, 2022.  CMS Ex. 2 at 41.

b. Analysis

Pursuant to 42 C.F.R. § 483.80, the substantive legal requirement is that Petitioner must establish and maintain an infection prevention and control program (IPCP) designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.  The SOD alleges violations of 42 C.F.R. § 483.80(b)(1)-(4) and (c).  CMS Ex. 2 at 41.  But the specific allegations, which are clarified by the testimony of Surveyor Harris, are that Petitioner’s DON could not produce a certificate showing that she had specialized training in infection prevention and control as required by 42 C.F.R. § 483.80(b)(4) or that Petitioner had any staff with such a certificate.  CMS Ex. 2 at 42-43, 80 at 1 ¶ 3, 10 ¶ 14J.

The evidence shows, and there is no dispute, that Petitioner’s DON who was also filling the role of Petitioner’s IP possessed professional training in nursing, was qualified by education and experience, and worked at least part-time in the facility, as required by 42 C.F.R. § 483.80(b)(1)-(3).  P. Ex. 16; P. Br. at 13-15.  But there is also no dispute that the DON had not completed specialized training in infection prevention and control, and the DON and Petitioner could provide no documentation that the DON had such specialized training or that another member of the staff was so trained.  The surveyors found and allege in the SOD that all Petitioner’s residents were at a risk for more than

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minimal harm due to the violation.  CMS Ex. 2 at 41-42.  The evidence shows that the violation existed from the departure of the prior IP in December 2021 and Petitioner’s plan of correction shows that the violation was not corrected until April 4, 2022, which was confirmed by a revisit survey.  CMS Exs. 2 at 41-42, 5 at 2.

CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.80(b)(4).  Petitioner bears the burden to show by a preponderance of the evidence that it was in substantial compliance with the participation requirement.  Petitioner does not meet its burden.

Petitioner argues that the regulation does not require that it have a “certified infection preventionist.”  P. Br. at 13.  Petitioner is correct that 42 C.F.R. § 483.80(b) does not state that Petitioner must have a “certified infection preventionist.”  But the regulation is clear that Petitioner’s IP must have “completed specialized training in infection prevention and control.”  42 C.F.R. § 483.80(b)(4).  Petitioner has presented no evidence that its DON or any other staff member had the required training from December 2021 to April 4, 2022.

Petitioner argues that no other violation of 42 C.F.R. § 483.80 was cited by the surveyors due to a deficiency in Petitioner’s IPCP.  And Petitioner argues that its DON’s abilities to handle Petitioner’s IPCP was demonstrated by the fact all IPCP requirements were met.  P. Br. at 14-15.  Petitioner’s assertions, while they may be true, do not excuse the regulatory violation that its IP have training required by 42 C.F.R. § 483.80(b)(4).

Petitioner failed to rebut the CMS prima facie showing of noncompliance with 42 C.F.R. § 483.80(b)(4).  Accordingly, I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.80(b)(4).  Petitioner has not rebutted that there was a risk for more than minimal harm due to the violation.

13.  Petitioner violated 42 C.F.R. § 483.25(g)(1)-(2) (Tag F692) – May 2022 survey.

14.  The violation of 42 C.F.R. § 483.25(g)(1)-(2) posed a risk for more than minimal harm.

15.  Petitioner has not shown by a preponderance of the evidence that it was in substantial compliance with the participation requirements established by 42 C.F.R. § 483.25(g)(1) and (2).

16.  Petitioner has not shown by a preponderance of the evidence that it corrected the noncompliance prior to May 20, 2022.

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The quality of care requirement related to nutrition is established by 42 C.F.R. § 483.25(g), which provides in part:

(g) Assisted nutrition and hydration. (Includes naso-gastric and gastrostomy tubes, both percutaneous endoscopic gastrostomy and percutaneous endoscopic jejunostomy, and enteral fluids). Based on a resident's comprehensive assessment, the facility must ensure that a resident—

(1) Maintains acceptable parameters of nutritional status, such as usual body weight or desirable body weight range and electrolyte balance, unless the resident’s clinical condition demonstrates that this is not possible or resident preferences indicate otherwise;

(2) Is offered sufficient fluid intake to maintain proper hydration and health; and

(3) Is offered a therapeutic diet when there is a nutritional problem and the health care provider orders a therapeutic diet.

42 C.F.R. § 483.25(g)(1)-(3).  The surveyors allege Petitioner violated the regulation in the case of Resident 1, who received enteral nutrition and hydration via a gastrostomy tube (g-tube), because Petitioner failed to adequately assess the resident’s impaired nutritional status, and implement, monitor and evaluate the effectiveness of interventions.  The surveyors allege that due to the violation, Resident 1 had weight loss of 17 percent in three months without nutritional intervention, and he was admitted to the hospital on March 31, 2022, due to severe malnutrition, dehydration, and high sodium level.  CMS Ex. 4 at 1-2.

a. Findings of Fact

Resident 1 was admitted to Petitioner on August 28, 2021.  His diagnoses included chronic respiratory failure, dysphagia (difficulty swallowing), tracheostomy, history of gastrostomy (g-tube placement), anemia, Type 1 diabetes mellitus, and a sacral, stage 2, pressure ulcer, among other conditions.  CMS Ex. 67 at 2-3, 17-23, 47; P. Ex. 17 at 2-3.13

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He was in the hospital from April 1 to 11, 2022, and April 27 to May 5, 2022.  CMS Ex. 67 at 47.

The following table summarizes Resident 1’s weight history from October 20, 202114 to April 11, 2022, providing an overview of the problem with Resident 1’s weight.

CMS Ex. 67 at 11-16; P. Ex. 17 at 8-10, 12.

The evidence includes Petitioner’s care plan for Resident 1 with a start date of October 6, 2021.  The problem noted is that Resident 1 was on tube feeding and that he was at risk for infections, dehydration or fluid overload, aspiration, and other complications related to tube feeding.  Possible malnutrition and weight loss were not specifically listed as potential problems.  Multiple approaches (interventions) were adopted October 6, 2021 with editing on December 11, 2021.  A final review/revision was done April 25, 2022, but no new or modified interventions were added to this care plan after December 11, 2021.  Interventions included, among others:  administering medications through the g-tube, administering feeding formula and water through the g-tube as directed; assessing for complications of tube feeding; assessing for dehydration; assessing for aspiration,

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vomiting, and diarrhea; assessing or checking gastric residual volume and bowel sounds; checking g-tube placement and patency; cleaning the g-tube as necessary; observing for bleeding or infection; monitoring intake and output each shift; monitoring for signs of malnutrition; monitoring laboratory results as ordered; monitoring weight and notifying the physician and family of any significant weight change; and monthly nutrition evaluation by the registered dietitian.  CMS Ex. 67 at 32-36.

Petitioner had a separate care plan for Resident 1 that identified that he had a problem with nutritional status as of September 9, 2021, that was edited on March 11, 2022.  The care plan listed Resident 1’s weights as follows: November 9, 2021, 139.1 pounds; January 11, 2022, 131.2 pounds; and February 10, 2022, 126.4 pounds; which was characterized as unplanned gradual weight loss.  The goal was no further weight loss.  Interventions listed included, among others: assessing laboratory results; monitoring for g-tube tolerance; monitoring skin and hydration; feeding as ordered to meet estimated nutritional needs for protein, calories, and fluid; monthly or as necessary registered dietitian assessment; and monitoring monthly weights.  CMS Ex. 67 at 37-38.

MARs for December 2021, January, February, and March 2022, show that Resident 1 was fed by g-tube Glucerna® 1.5 Cal (“0.08-1.5 gram-kcal/ml”) 60 ml (milliliter) over 20 hours with a 250 ml water flush every 6 hours based on an order originally issued September 20, 2021.  CMS Ex. 67 at 39, 41, 46; P. Ex. 17 at 14, 16, 18, 23.  MARs for December 2021, January, February, and March 2022, list the order for 60 ml of Glucerna® 1.5 Cal per hour for 20 hours with 250 ml of water flush every six hours as in effect beginning September 20, 2021 and it was to be discontinued March 25, 2022.  CMS Ex. 67 at 39, 41, 46; P. Ex. 17 at 14, 16, 18, 23.15

Registered dietitian progress notes from December 26, 2021 through March 24, 2022, show that Resident 1 was receiving Glucerna® 1.5 Cal, 60 ml per hour for 20 hours, a 250 ml water flush every six hours, and Pro-Stat® AWC 30 ml twice daily providing an additional 34 gm of protein.  Total nutrition according to the progress notes was 2000 kcal16 daily including 133 gm of protein and 1911 ml of water.  CMS Ex. 67 at 13-16.

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A registered dietitian progress note dated December 26, 2021, confirms that Resident 1 was fed by g-tube Glucerna® 1.5, 60 ml every 20 hours with a 250 ml water flush every 6 hours.  The progress note indicates that the tube feeding of 1200 ml over 20 hours provides 1800 kcal with 99 gram (gm) protein, and 1911 ml of water.  Resident 1 was also receiving 30 ml of Pro-Stat® AWC twice a day.  The December 26, 2021 progress note also records that Resident 1 weighed 145.1 pounds on October 20, 2021, 141.8 pounds on November 5, 2021, 139.1 pounds on November 9, 2021, and 139 pounds on December 5, 2021.  The note indicates that Resident 1’s physician determined he needed 1581-1897 kcal, 63-76 gm of protein, and 1561-1897 ml of water, I infer per day though that is not specified in the note.  The note states that tube feeding provides Resident 1 with 100 percent of his estimated needs.  CMS Ex. 67 at 16; P. Ex. 17 at 11.  Based on the note, Resident 1 was receiving 1911 ml of water which was more than 100 percent of the order for 1561-1897 ml of water the physician determined necessary; 99 gm of protein which was more than the 63-70 grams the physician determined necessary; but Resident 1 was receiving 1800 kcal which is slightly below the high end of the range of kcal of 1581-1896 the physician determined necessary.  However, I recognize that Resident 1 may have been receiving some kcal from the 60 ml of daily Pro-Stat® AWC he received daily but the note is not clear as to how many kcal that might have been.

A registered dietitian progress note from January 30, 2022, includes the same information as the December 26, 2021 progress note and adds that the 30 ml of Pro-Stat® AWC adds 34 grams of protein and 200 calories for a total of 2000 kcal, 133 gm of protein, and 1911 ml of water.  This note thus clarifies that Resident 1 was provided nutrition in excess of what his physician determined necessary.  Nevertheless, the January 30, 2022 progress note shows that Resident 1’s weight on January 11, 2022, was 131.2 pounds, which was down 7.8 pounds from the 139 pounds he weighed on December 5, 2022.  The registered dietitian noted that Resident 1 had a significant unplanned weight loss in the past one to three months.  CMS Ex. 67 at 15; P. Ex. 17 at 10.

A registered dietitian progress note from February 19, 2022, shows that Resident 1 was still receiving Glucerna® 1.5, 60 ml every 20 hours with a 250 ml water flush every 6 hours by g-tube.  The progress note indicates that the tube feeding of 1200 ml over 20 hours provides 1800 kcal with 99 gm protein, and 1911 ml of water.  Resident 1 was also receiving 30 ml of Pro-Stat® AWC twice a day adding 34 grams of protein and 200 calories for a total of 2000 kcal, 133 gm of protein, and 1911 ml of water.  Resident 1’s February 7, 2022 weight was 128.8 pounds and his February 10, 2022 weight was 126.4 pounds.  The registered dietitian noted that Resident 1’s weight showed a significant loss in three months despite tube feeding providing 100 percent of his estimated nutrition needs.  She noted he was at high risk for malnutrition.  She recommended increasing Glucerna® 1.5 to 65 ml for 20 hours, providing 1950 kcal, 107 gm protein, and 1987 ml of water.  CMS Ex. 67 at 14; P. Ex. 17 at 9.  I infer that the increased Glucerna® plus the

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existing order for Pro-Stat® would have increased Resident 1’s nutrition to approximately 2150 kcal, 141 gm of protein, and 1987 ml of water.

A registered dietitian note from March 24, 2022 shows that, despite the registered dietitian’s recommendation on February 19, 2022, Resident 1 continued to receive 60 ml of Glucerna® 1.5 for 20 hours with a 250 ml water flush every 6 hours, and Pro-Stat® AWC 30 ml twice a day for total daily of 2000 kcal, 133 gm protein, and 1911 ml of water.  The progress notes list weights of 118.8 pounds on March 5, 2022, and 118.6 pounds on March 10, 2022.  She noted that the resident’s estimated needs according to his physician were lower than listed in the February 18, 2022 progress note.  The registered dietitian states that Resident 1 has had a significant weight loss in the past one to three months despite the fact that tube feeding was thought to provide 100 percent of his needs, which is inconsistent with the recommendation in her February 19, 2022 progress note to increase nutrition and fluids.  The registered dietitian states that the resident’s weight loss was possibly due to recent acute infection including a urinary tract infection and clostridioides difficile (C. diff.) and concludes his weight loss was unplanned and unavoidable.  CMS Ex. 67 at 13; P. Ex. 17 at 8.  This is the first mention by the registered dietitian that weight loss was unavoidable due to the resident’s infections or for any other reason.  Her opinion that weight loss was unavoidable is not supported by a sufficient statement of her findings that support her opinion.  The registered dietitian recognized that the resident, who the evidence shows had been receiving the same diet since September 2021, began losing weight in December 2021, and she does not reveal if the infections and antibiotics for treatment were a factor for that long.  She does not address why her February 19, 2022 recommendation to increase nutrition and water (CMS Ex. 67 at 14; P. Ex. 7 at 9) was not acted upon by the resident’s physician or implemented by staff.  She does not opine whether weight loss could have been stopped or slowed had Resident 1 received the additional nutrition.  But I infer that is more likely than not why she recommended increased nutrition being delivered.  I also note that the recommendation for increased nutrition is inconsistent with an opinion that Resident 1’s weight loss was due to his infections and antibiotic therapy.  According to nurse practitioner and physician notes, Resident 1 completed his antibiotics for C. diff. by February 24, 2022 (P. Ex. 17 at 32-33) and for a urinary tract infection (UTI) by March 18 or 24, 2022 (P. Ex. 17 at 24, 28).  Resident 1 was first diagnosed with C. diff. between about January 22 and February 4, 2022.  P. Ex. 17 at 34-36.  Physician and nurse practitioner notes first note the UTI on March 11, 2022, based on a laboratory test.  P. Ex. 17 at 29.  The registered dietitian notes from December 26, 2021 and January 30, 2022, indicate that on December 23, 2021, Resident 1 completed antibiotic therapy for sepsis related to a malfunction or leak of his g-tube.  CMS Ex. 67 at 15-16.  Her March 24, 2022 note continues to list a plan to increase Resident 1’s feedings to Glucerna® 1.5 to 65 ml per hour for 20 hours.  She suggested Resident 1 needed a total of 1300 ml of the food to provide 1950 kcal, 107 gm of protein, and 1987 ml of water.  CMS Ex. 67 at 13; P. Ex. 17 at 8.  The registered dietitian does not address why she did not recommend a change in diet in December 2021 or January 2022, when she first noted weight loss.  I infer based

on the registered dietitian notes that Resident 1’s weight loss was not intentional.  Had the registered dietitian been called to testify, clarity may have been achieved, but she was not and her opinion that weight loss was due to infections and antibiotic therapy is rejected as unsupported.

Physician and nurse practitioner notes from December 13, 2021 through March 31, 2022 do not address Resident 1’s weight loss.  P. Ex. 17 at 24-42.  However, a nurse practitioner note on March 30, 2022 at 3:26 p.m. indicates that Resident 1’s tube feeding was recently adjusted by the registered dietitian due to weight loss.  P. Ex. 17 at 24.  The nurse practitioner note does not indicate that she or the physician ordered the change in diet or what the change was.  But the evidence shows that Petitioner’s physician increased Resident 1’s Glucerna® on March 25, 2022, to 65 ml.  P. Ex. 17 at 13.  The increase to 65 ml was consistent with the registered dietitian’s recommendation on February 19, 2022.  CMS Ex. 67 at 14; P. Ex. 17 at 9.

Resident 1 was admitted to the hospital on March 31, 2022, and readmitted to Petitioner on April 11, 2022.  CMS Ex. 67 at 2, 6, 47.  Resident 1 was admitted to the hospital on March 31, 2022, for hypernatremia (high sodium level), dehydration, uncontrolled diabetes mellitus, and pressure ulcers.  He was noted to have a history of chronic respiratory failure with a tracheostomy, enteral feeding because he could have nothing by mouth, and malnutrition.  A comprehensive nutrition assessment was done on April 5, 2022.  CMS Ex. 67 at 6-10.  Resident 1’s weight was 121 pounds and 4.1 ounces (oz.).  His ideal body weight was noted to be 172 pounds.  The hospital dietitian determined Resident 1 had 17 pounds weight loss, i.e., 12 percent, in three months, which was characterized as clinically significant.  The dietitian determined Resident 1 weighed 138 pounds on December 22, 2021, and he weighed 121 pounds, 4 oz. on April 1, 2022.  He was also noted to have muscle depletion. CMS Ex. 67 at 8, 11.  The dietitian opined that Resident 1 was receiving inadequate enteral nutrition and fluids with enteral nutrition being only 81 percent of the resident’s needs.  She determined Resident 1 was suffering from severe malnutrition and recommended increasing Resident 1’s feedings, adjusting his fluid intake as ordered by his physician, and monitoring his weight.  CMS Ex. 67 at 9-11.  The hospital records indicate that Resident 1 suffered from severe temporal, clavicular, and thigh/patellar muscle depletion, and he suffered clinically significant weight loss in the last three months.  The hospital assessed Petitioner as having received inadequate enteral nutrition and fluids resulting in him being underweight.  He was diagnosed as being malnourished with significant weight loss and muscle depletion.  The hospital dietitian assessed Resident 1’s nutrition needs as 1925-2200 kcal every 24 hours, 83-110 gm of protein every 24 hours, 217-248 grams of carbohydrate every 24 hours, and 1925-2200 ml of fluid every 24 hours.  CMS Ex. 67 at 6-10; P. Ex. 18.

A registered dietitian note from April 13, 2022, shows Resident 1’s feeding had been increased from 60 ml of Glucerna® 1.5 an hour for 20 hours to 65 ml per hour, with a 250 ml water flush every six hours.  The registered dietitian also recommended Pro-Stat®

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AWC 30 ml twice a day.  I find significant that the note reflects Resident 1’s weight increased to 121 pounds as of April 11, 2022 (when he was readmitted to Petitioner from the hospital), which was up from 118.6 pounds as of March 10, 2022 and 118.8 pounds on March 5, 2022.  CMS Ex. 67 at 12.  I draw two inferences from this important fact:

1.  The increased diet beginning March 25, 2022, supported Resident 1’s weight gain; and

2.  The increase in weight is inconsistent with Petitioner’s registered dietitian’s opinion that weight loss was unavoidable and further grounds for rejecting her opinion.

The evidence includes the following orders showing that Petitioner’s registered dietitian’s recommendation to increase Resident 1’s feedings was finally acted upon by the resident’s physician beginning on March 25, 2022 and continuing through April 27, 2022.

Pro-Stat® AWC liquid, 17-100 gram-kcal/30 ml (milliliters), twice per day at 9:00 a.m. and 5:00 p.m., April 14 through 27, 2022.  CMS Ex. 67 at 21.  There is evidence Resident 1 started receiving Pro-Stat® AWC 17-100 gm-kcal, 30 ml twice a day beginning on about August 30, 2021.  P. Ex. 17 at 5.

Glucerna® 1.5 Cal, 0.08-1.5 gram-kcal/ml, 65 ml (I infer per hour over 20 hours) ordered March 25, 2022.  P. Ex. 17 at 13.

Glucerna® 1.5 Cal liquid, 0.08-1.5 gram-kcal/ml, 65 ml per hour over 20 hours with 300 ml water flush every four hours for April 13 and 14, 2022, which was changed to 250 ml water flush every four hours for April 14, 2022, and every six hours for April 14 through April 27, 2022.  CMS Ex. 67 at 20.

Turn on feeding pump at 10 a.m. and 2 p.m. with Glucerna® 1.5 at 65 ml per hour for April 14 through 27, 2022.  Water flush of 250 ml every six hours at 7:00 a.m., 1:00 p.m., 7:00 p.m., and 1:00 a.m.  CMS Ex. 67 at 19.

Glucerna® 1.5 Cal liquid, 0.08-1.5 gram-kcal/ml, 65 ml over 20 hours with 250 ml water flush every six hours for the period April 11 through 13, 2022.  CMS Ex. 67 at 19.  A similar order created April 13, 2022 provides for continued use of Glucerna® in the same way but with a 300 ml water flush every four hours.  P. Ex. 17 at 51.

Turn on feeding pump at 12 p.m. with Glucerna® 1.5 at 65 ml/hr, clearing the pump prior to feeding, for the period April 11 through 14, 2022.  CMS Ex. 67 at 18.

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Surveyor Karyn Rundle was the team coordinator for the complaint investigation at Petitioner completed on May 3, 2022.  CMS Ex. 86 at 1 ¶ 3.  In her declaration, she testified that she reviewed medical records for Resident 1.  CMS Ex. 86 at 3 ¶ 11.  Surveyor Rundle opined that Petitioner violated 42 C.F.R. § 483.25(g)(1) and (2) because Petitioner failed to adjust Resident 1’s feedings despite documented weight loss which caused the resident to be admitted to the hospital with diagnosis of malnutrition and dehydration.  She testified that a clinically significant weight loss such as that suffered by Resident 1 is a sign of poor nutritional status that required intervention, including assessment of diet, clinical condition, and other relevant factors.  CMS Ex. 86 at 13 ¶ 18.  She testified that a clinically significant or severe weight loss is loss of five percent over one month, more than 7.5 percent over three months, and more than 10 percent over six months.17  She found that Resident 1 lost 5.6 percent between December 5, 2021 and January 11, 2022, which was clinically significant.  She testified that Resident 1 continued to lose weight from January 2022 through March 24, 2022, but Petitioner made no adjustment to his diet.  CMS Ex. 86 at 14 ¶¶ 18F, 18G.  She calculated that Resident 1 lost 14.68 percent of his weight from December 5, 2021 through March 10, 2022.  CMS Ex. 86 at 14 ¶ 18H.  She opined that as early as March 25, 2022, Petitioner increased Resident 1’s nutrition (CMS Ex. 86 at 14 ¶ 18I) which is consistent with the physician order reflected in P. Ex. 17 at 13 that provided for an increase in Resident 1’s Glucerna® from 60 to 65 ml per hour.  The nutrition history reported to the hospital on about March 31, 2022, also reflected the change to 65 ml of Glucerna®.  CMS Ex. 67 at 7.  Surveyor Rundle concluded Petitioner violated 42 C.F.R. § 483.25(g)(1) because Petitioner did not adjust Resident 1’s diet due to his clinically significant weight loss between December 2021 and March 24, 2021.  CMS Ex. 86 at 15 ¶ 18N.  She opined the evidence does not show that Resident 1’s weight loss was unavoidable because the evidence does not show Petitioner assessed and reassessed Resident 1’s dietary needs, monitored Resident 1’s diet for effectiveness, and coordinated care among the interdisciplinary team.  CMS Ex. 86 at 15-16 ¶¶ 18O-P.  Although I conclude that Petitioner has not established by a preponderance of the evidence Resident 1’s weight loss was unavoidable, I disagree with Surveyor Rundle that Petitioner failed to monitor the effectiveness of Resident 1’s diet prior to March 24, 2022.  Indeed, there is evidence of monitoring by Petitioner’s

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registered dietitian, and the assessment Resident 1 was losing weight.  Despite the monitoring and assessment, Petitioner neglected to act including neglecting18 to act upon the registered dietitian’s recommendation to increase Resident 1’s caloric intake.  Surveyor Rundle also opines that the fact Resident 1 had a UTI and C. diff. with antibiotic treatment is not a credible explanation for his clinically significant weight loss or show that increasing Resident 1’s diet, even while he had infections and treatment, would not have stopped or prevented his weight loss.  CMS Ex. 86 at 16 ¶ 18Piii.

The SOD shows that the surveyors determined that the violation of 42 C.F.R. § 483.25(g)(1)-(3) posed a risk for more than minimal harm and caused actual harm for Resident 1.  The surveyors’ determination is consistent with the fact Resident 1 was hospitalized for malnutrition and dehydration on March 31, 2022.  CMS Ex. 67 at 6-10; P. Ex. 18.  Petitioner has not disputed that malnutrition and dehydration amount to actual harm.  Petitioner indicates in its plan of correction that the noncompliance was corrected as of May 20, 2022.  CMS Ex. 4 at 1 (two columns on right).  A revisit survey conducted by the state agency on June 13, 2022, determined that Petitioner corrected the noncompliance as of May 20, 2022.  CMS Ex. 5 at 3.

b. Analysis

The quality of care participation standard is established by 42 C.F.R. § 483.25, which provides:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.

42 C.F.R. § 483.25.

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The specific quality of care requirements the surveyors allege Petitioner violated are 42 C.F.R. § 483.25(g)(1)-(3) (CMS Ex. 4 at 1), which provide:

Based on a resident’s comprehensive assessment, the facility must ensure that a resident –

(1) Maintains acceptable parameters of nutritional status, such as usual body weight or desirable body weight range and electrolyte balance, unless the resident’s clinical condition demonstrates that this is not possible or resident preferences indicate otherwise;

(2) Is offered sufficient fluid intake to maintain proper hydration and health; and

(3) Is offered a therapeutic diet when there is a nutritional problem and the health care provider orders a therapeutic diet.

42 C.F.R. § 483.25(g)(1)-(3).  There is no dispute that Resident 1 had orders for feeding by g-tube and the SOD does not otherwise allege a violation of 42 C.F.R. § 483.25(g)(3) and that subsection is not considered further.  Three possible defenses are established by 42 C.F.R. § 483.25(g)(1):  (1) nutrition provided was adequate; (2) the resident’s clinical condition makes it impossible to maintain acceptable parameters of nutrition; and (3) a resident does not maintain acceptable parameters of nutrition because of personal preference.

The Board has provided some guidelines for the application of 42 C.F.R. § 483.25(g)(1) in prior decisions regarding the predecessor regulatory provision 42 C.F.R. § 483.25(i)(1).19  Those guidelines include:

A facility is responsible for taking all reasonable steps to ensure a resident receives adequate nutrition to meet his or her needs;

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A facility is not required to keep a resident’s weight at a fixed level;

A facility is not strictly liable for a resident’s weight loss;

It is a defense to an allegation of noncompliance that maintaining the resident’s weight is clinically impossible;

Weight may be evidence of nutritional status;

If a resident receives adequate nutrition and weight loss is due to non-nutritive factors, then weight is not evidence of nutritional status and weight loss is not the basis for citation of a regulatory violation;

Weight loss may trigger an inference of adequate nutrition sufficient to make the CMS prima facie showing of a regulatory violation;

A facility may rebut a prima facie showing of a regulatory violation based on evidence of a resident’s weight loss by showing by a preponderance of the evidence that it provided adequate nutrition; and

If a facility cannot show that it provided adequate nutrition, it may still show that the resident’s clinical condition made it impossible to maintain adequate nutrition such as in the case of a resident with throat cancer and the family refused a feeding tube, in which case weight loss may be considered unavoidable.

The Windsor House, DAB No. 1942 at 10-11 (2004); Carehouse Convalescent Hosp., DAB No. 1799 at 21-22 (2001).

The Board has addressed various issues related to the hydration requirement now found in 42 C.F.R. § 483.25(g)(2).  The Board has found that a diagnosis of dehydration upon admission to a hospital from a facility is sufficient to establish the CMS prima facie case of a violation of the hydration requirement.  Woodland Vill. Nursing Ctr., DAB No. 2053 (2006), aff’d, Woodland Vill. Nursing Ctr. v. U.S. Dep’t of Health & Human Servs., 239 F. App’x 80 (5th Cir. 2007).  If CMS makes a prima facie showing, the burden is upon a petitioner to show by a preponderance of the evidence that it complied with the regulatory requirement.  Specifically, a petitioner must show it took adequate steps based on the resident’s comprehensive assessment, professional standards of practice, the resident’s care plan, and the resident’s preferences, to ensure the resident was offered adequate hydration to maintain proper hydration and health.  Cmty. Skilled Nursing Ctr., DAB No. 1987 at 16 (2005) (the facility had the burden to show that the resident “became dehydrated despite care that was consistent with professional standards of quality for preventing dehydration in someone of [the resident’s] condition”).  The

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regulatory requirement to offer adequate hydration does not state that it is limited to only residents who are assessed as at risk for dehydration.  All residents must be offered adequate hydration which they can ingest or otherwise receive so that they can maintain hydration and good health.

This case is unlike many nutrition and hydration cases because the evidence shows that Resident 1 received all his nutrition and hydration by a g-tube from his first admission to Petitioner in August 2021.  CMS Ex. 67 at 2-3, 17-23, 47; P. Ex. 17 at 2-3.  Petitioner’s care plans for Resident 1 required that feeding formula, water, and medications were administered through the resident’s g-tube.  The care plans required that Resident 1 be assessed for dehydration and monitoring for malnutrition including monitoring laboratory results and weight and notifying the attending physician and family of any significant weight change.  A monthly evaluation by the registered dietitian was also required.  CMS Ex. 67 at 32-38.

The evidence shows that as early as September 20, 2021, Resident 1 was receiving feeding formula listed as Glucerna® 1.5 Cal, 60 ml per hour for 20 hours with 250 ml water flushes every six hours.  CMS Ex. 67 at 39, 41, 46; P. Ex. 17 at 14, 16, 18, 23.  MARs for December 2021, January, February, and March 2022, list the order for 60 ml of Glucerna® 1.5 per hour for 20 hours with 250 ml of water flush every six hours as in effect beginning September 20, 2021 and it was to be discontinued March 25, 2022.  CMS Ex. 67 at 39, 41, 46; P. Ex. 17 at 14, 16, 18, 23.  Registered dietitian progress notes from December 26, 2021 through March 24, 2022 show that Resident 1 was receiving Glucerna® 1.5 Cal, 60 ml per hour for 20 hours, a 250 ml water flush every six hours, and Pro-Stat® AWC 30 ml twice daily providing an additional 34 gm of protein.  Total nutrition according to the progress notes was 2000 kcal daily including 133 gm of protein and 1911 ml of water.  CMS Ex. 67 at 13-16.  However, as the table previously shared shows, Resident 1 began losing weight in October 2021 and that weight loss continued through at least March 10, 2022.

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CMS Ex. 67 at 11-16; P. Ex. 17 at 8-10, 12.  The table shows that between October 20, 2021 and January 11, 2022, Resident 1 lost approximately 13.9 pounds, dropping from 145.1 to 131.2 pounds, i.e., 13.9 percent of weight lost in just under three months.  The standard adopted by CMS is that a weight loss greater than 7.5 percent in three months is severe weight loss.  Therefore, as of January 11, 2022, Resident 1 had experienced a severe weight loss, which should have been sufficient to trigger assessment of whether he was receiving inadequate nutrition.

The evidence shows that Petitioner’s registered dietitian did not record that she considered the possibility of inadequate nutrition even though she noted that the resident had a significant unplanned weight loss in the past one to three months.  CMS Ex. 67 at 15; P. Ex. 17 at 10.  I infer that on February 19, 2022, Petitioner’s registered dietitian did assess Resident 1 as receiving inadequate nutrition because she recommended an increase in his Glucerna®.  CMS Ex. 67 at 14; P. Ex. 17 at 9.  Unfortunately, Resident 1’s weight loss became even more severe, dropping to 118.6 pounds before action was taken to implement the dietitian’s recommendation to increase the resident’s nutrition on March 25, 2022.  P. Ex. 17 at 13; CMS Ex. 67 at 19.

Progress notes by Petitioner’s registered dietitian show that she was monitoring Resident 1’s weight.  CMS Ex. 67 at 16; P. Ex. 17 at 11.  The dietitian’s January 30, 2022 progress note indicates she recognized that Resident 1 had a significant unplanned weight loss in one to three months.  CMS Ex. 67 at 15; P. Ex. 17 at 10.  In her February 19, 2022 note, the registered dietitian again noted a significant weight loss and that Resident 1 was at high risk for malnutrition, and she recommended increasing his Glucerna® from 60 ml per hour for 20 hours to 65 ml per hour for 20 hours.  CMS Ex. 67 at 14; P. Ex. 17 at 9.  The registered dietitian notes dated March 24, 2022 show Resident 1 continued to receive only 60 ml per hour of Glucerna® despite the registered dietitian’s February 19, 2022 recommendation.  Resident 1 had continued to lose weight and was down to 118.6 pounds on March 10, 2022.  CMS Ex. 67 at 13; P. Ex. 17 at 8.  Therefore, between December 5, 2021 and March 10, 2022, Resident 1’s weight dropped from 139 pounds to 118. 6 pounds, a loss of 20.4 pounds which was 14.68 percent of his body weight.  CMS Ex. 67 at 11-16; P. Ex. 17 at 8-10, 12.  But on March 25, 2022, Resident 1’s Glucerna® was increased to 65 ml per hour for 20 hours and by April 11, 2022, when he was readmitted to Petitioner from the hospital, his weight had increased to 121 pounds.  CMS Ex. 67 at 12.  It is distressing to note that Resident 1’s severe weight loss, i.e., greater than 10 percent in less than six months (CMS Ex. 1 at 47), is not even mentioned in the physician and nurse practitioner notes until a March 30, 2022 note that states the registered dietitian adjusted Resident 1’s feeding due to his weight loss.  P. Ex. 17 at 24-42.

In this case, I conclude that Resident 1’s weight loss (CMS Ex. 67 at 11-16; P. Ex. 17 at 8-10, 12), the evidence Petitioner’s registered dietitian recommended in February 2022

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increasing his feeding of Glucerna® to 65 ml per hour from 60 ml per hour due to his weight loss (CMS Ex. 67 at 14; P. Ex. 17 at 9), plus the hospital diagnoses that he was malnourished and dehydrated on admission (CMS Ex. 67 at 9-10; P. Ex. 18) is sufficient to be a prima facie showing of a violation of 42 C.F.R. § 483.25(g)(1) and (2) that caused Resident 1 actual harm because he had to be hospitalized.  Therefore, the regulatory violation posed more than minimal harm and was noncompliance.

Petitioner argues that all Resident 1’s needs were met by Petitioner who was following its policies and CMS guidelines.  Petitioner notes Resident 1 was stable until December 2021, when he developed infections that required months of antibiotic therapy.  Petitioner argues its registered dietitian monitored Resident 1 extensively; she concluded the diet ordered met 100 percent of the resident’s needs; and she concluded that Resident 1’s weight loss was unavoidable.  Petitioner acknowledges it did finally change Resident 1’s diet.  But Petitioner argues it was the fact that Petitioner was off antibiotics that resulted in him gaining weight.  Petitioner asserts that the citation of noncompliance was based on the surveyor’s misinterpretation of hospital records.20  P. Br. at 16-22; P. Reply at 6.  Petitioner does not deny Resident 1 was dehydrated on admission to the hospital on March 2022 and does not discuss that fact in briefing.

I note that there is no issue raised by Petitioner that Resident 1’s preferences caused or contributed to his weight loss.  I conclude that that possible defense under 42 C.F.R. § 483.25(g)(1) is not raised in this case.  I also conclude that Petitioner has failed to establish by a preponderance of the evidence, i.e., that it was more likely than not, that Resident 1’s weight loss was not due to Petitioner’s failure to ensure he was provided adequate nutrition but was unavoidable due to his infections and antibiotic therapy.  Petitioner relies in large part upon the opinion of its registered dietitian.  However, other than the representation that the registered dietitian is a registered dietitian, I have little or no information regarding the registered dietitian’s education, training, or experience that allows me to give much weight to her opinion.  Petitioner cites no evidence to support its position that its registered dietitian is qualified to render opinions that infections and antibiotic therapy are likely causes of Resident 1’s weight loss.  Further, as already discussed in my findings of fact, the dietitian’s opinions are not consistent with the facts which show infections and antibiotic therapy but which also show weight loss beginning before and continuing after infections and antibiotic therapy.  I weigh more heavily the evidence that the registered dietitian seemed convinced in February 2022 that the weight loss was due to inadequate nutrition and she recommended increasing the resident’s diet.  Also weighty is the fact that the resident gained weight when his diet was subsequently

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increased.  I find a more likely and credible cause-and-effect relationship between the increased diet and increased weight than the increased weight and the cessation of antibiotic therapy given the fact that there was no weight gain on cessation of the antibiotics until there was an increase in diet.  I also consider that Resident 1 had a physician, and the physician’s opinions are not presented to me.  Nor is there any explanation for why the physician and nurse practitioners did not address the resident’s weight loss in progress notes until after the diet change was made.  Petitioner also presents no evidence of the interdisciplinary team (42 C.F.R. § 483.21(b)(2)(iii)) addressing the resident’s weight loss from December 2021 until March 24, 2022.  Although the registered dietitian recorded in her progress notes her opinion that the diet ordered for Resident 1 met 100 percent of his needs, the resident’s continued weight loss and the opinion of the hospital dietitian show that Petitioner’s registered dietitian’s opinion the resident had adequate nutrition is simply not weighty.

I conclude Petitioner has failed to rebut the CMS prima facie showing and meet its burden to show by a preponderance of the evidence that it remained in substantial compliance with the requirement of 42 C.F.R. § 483.25(g)(1) and (2) in the case of Resident 1.  Petitioner’s plan of correction states Petitioner corrected this noncompliance effective May 20, 2022 (CMS Ex. 4 at 1) and that was confirmed by a revisit survey on June 13, 2022 (CMS Ex. 5 at 3).  Petitioner does not allege before me it returned to substantial compliance earlier than May 20, 2022, only that there was never noncompliance.

17.  Petitioner violated 42 C.F.R. § 483.45(f)(2) (Tag F760) – May 2022 survey.

18.  The violation of 42 C.F.R. § 483.45(f)(2) posed a risk for more than minimal harm to Resident 1.

19.  Petitioner has not shown by a preponderance of the evidence that it was in substantial compliance with the participation requirements established by 42 C.F.R. § 483.45(f)(2).

20.  Petitioner has not shown by a preponderance of the evidence that it corrected the noncompliance prior to May 20, 2022.

Petitioner is required by 42 C.F.R. § 483.45(f)(2) to ensure that its “[r]esidents are free of any significant medication errors.”  42 C.F.R. § 483.45(f)(2).  CMS has, as a matter of policy, defined significant medication error as one that causes a resident discomfort or jeopardizes his or her health and safety.  SOM, app. PP, Tag F760 (eff. Nov. 28, 2017).  Petitioner has not taken issue with the CMS definition.  P. Br. at 23.

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The surveyors allege that Petitioner’s staff failed to adequately monitor Resident 1’s blood sugar prior to administering insulin to determine the correct dose to prevent high blood sugar levels, which resulted in Resident 1 being transported to the hospital on March 31 and April 27, 2022.  CMS Ex. 4 at 6.

a. Findings of Fact

Resident 1 is the same resident discussed under Tag F692 above.  Resident 1 was admitted to Petitioner’s facility on August 28, 2021.  Resident 1’s records show he had diabetes.  According to Petitioner’s face sheet for Resident 1 he had Type 1 diabetes.  CMS Ex. 67 at 3.  Resident 1’s progress notes also indicate he suffered Type 1 diabetes.21  CMS Ex. 67 at 12-16; P. Exs. 17-18.  Physician order reports list Type 1 diabetes under the resident’s summary data.  CMS Ex. 67 at 17-23.  Resident 1 had a history of both high (hyperglycemia) and low (hypoglycemia) blood glucose events.  P. Ex. 17 at 2; P. Ex. 18 at 2.

According to a progress note dated August 30, 2021, at 6:44 p.m. at admission to Petitioner he had the following orders for insulin:

Humalog U100 insulin, 100 unit/ml, five units administered subcutaneously every 6 hours; and

Humulin R U500 insulin 500 unit/ml every six hours subcutaneously according to a sliding scale (I infer this to mean that the dose of the Humulin varied according to the resident’s blood sugar reading).

P. Ex. 17 at 2, 5.  The plan for managing Resident 1’s diabetes was to follow the hypoglycemia protocol, providing an ADA (American Diabetes Association) diet (although he was already on tube feeding), insulin on a sliding scale, keeping his blood sugar less than 150 mg/dl (without mention of a low end of the range of acceptable blood glucose levels), and having his A1C checked every three months.  P. Ex. 17 at 6.

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Petitioner’s care plan for Resident 1 dated October 6, 2021, lists diabetes mellitus as a problem.  The only goal listed was to keep the resident’s blood glucose levels within physician ordered parameters with no signs or symptoms of hypoglycemia or hyperglycemia.  Interventions listed required monitoring blood glucose according to the MAR, providing insulin on a sliding scale as ordered, notifying the resident’s physician if the resident’s blood sugar was less than 70 mg/dl (milligrams per deciliter) or more than 450 mg/dl, and monitoring for signs or symptoms of hypoglycemia and hyperglycemia.  CMS Ex. 67 at 29-30.  The evidence before me does not include a physician order establishing physician ordered parameters for Resident 1’s blood glucose levels, and the only parameters in evidence are the parameters of 70 mg/dl to 450 mg/dl when the physician required notification of blood glucose readings above or below that range.  The care plan clearly required monitoring of blood glucose according to the MAR, but no copy of a MAR addressing monitoring of blood glucose is in evidence.  The care plan also indicates that the physician expected blood glucose monitoring and notification when blood glucose was outside the specified range.  The care plan was specific that the amount of insulin to be administered was to be determined using a sliding scale, which I infer was based on blood glucose readings for Resident 1.

A nurse practitioner note from December 22, 2021, at 10:41 a.m. shows Resident 1 had a blood glucose of 32 mg/dl but no treatment is noted.  P. Ex. 17 at 41.

A nurse practitioner progress note dated March 8, 2022, at 2:02 p.m. indicates Resident 1 had a hyperglycemic event with a blood glucose of 517 that was corrected with insulin.  P. Ex. 17 at 30-31.  A nurse practitioner note from March 4, 2022, at 2:10 p.m. indicates that blood glucose checks for the resident were mostly less than 150 mg/dl, but increasing highs were being noted.  P. Ex. 17 at 31.

Resident 1 was admitted to the hospital on March 31, 2022,22 and laboratory results at 11:12 p.m. show blood glucose of 307 mg/dl which is characterized as high.  P. Ex. 18 at 2.

A physician order report for April 11 (the day Resident 1 returned to Petitioner from the hospital) through May 27, 2022, listed the following orders for insulin:

Novolin N NPH U100 insulin 10 units subcutaneous twice a day at 9:00 a.m. and 5:00 p.m.; and

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Humulin N NPH U100 insulin 10 units subcutaneous twice a day at 9:00 a.m. and 5:00 p.m.

CMS Ex. 67 at 20.

A physician order with a start date of April 14, 2022, at 5:00 p.m. and a discontinue date of April 27, 2025 at 8:06 a.m. ordered Humulin N NPH U100 10 units subcutaneously, twice per day at 9:00 a.m. and 5:00 p.m.  P. Ex. 17 at 52.

CMS placed in evidence two of Petitioner’s policies related to diabetic residents.  CMS Exs. 69, 70.  Neither policy provides guidance regarding a sliding scale, staff reaction to blood glucose readings that are too high or too low, or staff-initiated treatment for hypoglycemia or hyperglycemia.

Surveyor Rundle testified in her declaration that in her opinion Petitioner violated 42 C.F.R. § 483.45(f)(2) by committing two significant medication errors when staff administered insulin to Resident 1 without first checking his blood sugar, which was inconsistent with professional standards of care.  She found that Resident 1 had to be admitted to the hospital twice due to the medication error, which I infer she found constituted actual harm to Resident 1.  CMS Ex. 86 at 16 ¶ 19; CMS Ex. 4 at 6.  Surveyor Rundle pointed out that Resident 1’s care plan required his blood glucose to be monitored as provided in the MAR.  CMS Ex. 67 at 29.  But she alleged that when she conducted the May 2022 complaint investigation, there was no order in the MAR for the period December 27, 2021 through April 11, 2022, to monitor Resident 1’s blood glucose levels.  CMs Ex. 86 at 17 ¶ 19I.  Surveyor Rundle states that Resident 1’s blood glucose was more than 400 ml/dl when he was admitted to the hospital on March 31, 2022.  CMS Ex. 85 at 17 ¶ J.  But that opinion is not supported by the documentary evidence which shows a blood glucose of 307 mg/dl at 11:10 p.m.  P. Ex. 18 at 2.  If there is evidence of a higher blood glucose of 400 ml/dl prior to Resident 1’s hospitalization on March 31, 2022, Surveyor Rundle did not cite to a document that is in evidence before me.  But the blood glucose of 307 mg/dl is described in the hospital report as high and that characterization has not been rebutted by Petitioner.  Surveyor Rundle notes that when Resident 1 returned to Petitioner from the hospital on April 11, 2022, his orders for insulin changed, but there was no order in his MAR to monitor his blood glucose between April 11 and 27, 2022.  CMS Ex. 86 at 17 ¶ 19K, L.  Surveyor Rundle states in her declaration that Resident 1 had to be readmitted to the hospital on April 27, 2022 at about 8:06 a.m. because his blood sugar was above 400 mg/dl.  CMS Ex. 86 at 17 ¶ 19M.  Petitioner’s records show that Resident 1 started hospital leave at 8:06 a.m. on April 27, 2022 and he returned to Petitioner on May 5, 2022 at 8:45 p.m.  CMS Ex. 67 at 47; P. Ex. 17 at 1.  I have received no documentary evidence created by Petitioner or the hospital that provides details regarding the reason for Resident 1’s hospitalization on April 27, 2022, or his treatment in the hospital.  But Petitioner does not dispute Surveyor Rundle’s

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testimony that Resident 1 was hospitalized for blood sugar above 400 mg/dl.  A laboratory report also shows that on April 24, 2022, Resident 1’s blood glucose was 506, on April 18, 2022, it was reported to be 409, both are characterized as critically high, and on April 14, 2022, his blood glucose was reported to be 134 and noted to be high.  CMS Ex. 67 at 1.  Surveyor Rundle testified to her interview of the nurse practitioner who said she checked Resident 1’s blood sugar and it was more than 400 mg/dl the morning of April 27, 2022.  Surveyor Rundle testified that the nurse practitioner told her staff was not checking Resident 1’s blood sugar before giving insulin, and that blood glucose should be checked before giving insulin.  CMS Ex. 86 at 17-18 ¶ 19N, O, P.  Surveyor Rundle testified it is standard of care to check the blood glucose level of a resident with Type 1 diabetes four times per day before administering insulin.  CMS Ex. 86 at 18 ¶ U.  Surveyor Rundle is an RN licensed in Illinois with nine years of experience as a surveyor at the time she made her declaration.  CMS Ex. 86 at 1 ¶ 1.  Surveyor Rundle’s testimony is credible, and her opinions are weighty given her training, experience, and her investigation of the facts.

CMS has stated in the SOM as a matter of policy that:

“Medication Error” means the observed or identified preparation or administration of medications or biologicals which is not in accordance with:

1.  The prescriber’s order;

2.  Manufacturer’s specifications (not recommendations) regarding the preparation and administration of the medication or biological; or

3.  Accepted professional standards and principles which apply to professionals providing services.  Accepted professional standards and principles include the various practice regulations in each State, and current commonly accepted health standards established by national organizations, boards, and councils.

“Significant medication error” means one which causes the resident discomfort or jeopardizes his or her health and safety.  Criteria for judging significant medication errors as well as examples are provided below.  Significance may be subjective or relative depending on the individual situation and duration, e.g., constipation that is unrelieved because an ordered laxative is omitted for one day, resulting in a medication error, may cause a resident slight discomfort or

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perhaps no discomfort at all.  However, if this omission leads to constipation that persists for greater than three days, the medication error may be deemed significant since constipation that causes an obstruction or fecal impaction can directly jeopardize the resident’s health and safety.

SOM, app. PP, Tag F760 (eff. Nov. 28, 2017).

Pursuant to the October 6, 2021 care plan (CMS Ex. 67 at 29-30) staff was to monitor blood glucose per the MAR.  But there is no evidence before me that shows there were ever instructions in the MAR informing Petitioner’s staff how or when to monitor Resident 1’s blood glucose.

The October 6, 2021 care plan directed staff to provide insulin per sliding scale parameters.  But there is no evidence before me that shows a specific sliding scale was ordered by Resident 1’s physician or used by staff in determining the correct dose of insulin for Resident 1.

The care plan directed staff to monitor for signs of hyperglycemia and hypoglycemia (blood glucose of less than 60 mg/dl) and to contact Resident 1’s physician if his blood glucose level was less than 70 mg/dl or more than 450 mg/dl.  There is evidence that staff checked Resident 1’s blood glucose levels.  P. Ex. 17 at 30-31, 41.  But there is no evidence documenting the regular taking of blood glucose levels or that the resident’s physician was notified that the resident’s blood glucose was ever outside the range set by his physician.

Petitioner’s plan of correction indicates it completed correction of the noncompliance as of May 20, 2022.  CMS Ex. 4.

b. Analysis

Long-term care facilities participating in Medicare must ensure that each resident is provided with routine and emergency drugs and biologicals.  42 C.F.R. § 483.45.  Regarding medication errors, the pharmacy services regulation requires that the facility must ensure that:

(1) It is free of medication error rates of five percent or greater; and

(2) Residents are free of any significant medication errors.

42 C.F.R. § 483.45(f).  There is no allegation in this case that Petitioner had a medication error rate of five percent or more.  Rather, CMS asserts that there was a significant

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medication error in this case because Petitioner’s staff failed to check Resident 1’s blood sugar before administering insulin.  CMS Br. at 27.

To make a prima facie showing of noncompliance under Tag F760 based on a violation of 42 C.F.R. § 483.45(f)(2), CMS must show that:

(1) Petitioner’s staff committed a medication error;

(2) The medication error was significant; and

(3) The violation posed a risk for more than minimal harm.

The regulation does not define “significant.”  However, the SOM and Board decisions describe a significant medication error as one that caused or may cause a resident discomfort or jeopardize a resident’s health and safety.  According to the SOM, app. PP, Tag F760, a medication error is the “observed or identified preparation or administration of medications or biologicals” not in accordance with:  prescriber’s order, manufacturer’s specifications, or accepted professional standards and principles applicable to the professional providing service.  A significant medication error is one that causes a resident discomfort or jeopardizes his or her health and safety.  The SOM states:

Significance may be subjective or relative depending on the individual situation and duration, e.g., constipation that is unrelieved because an ordered laxative is omitted for one day, resulting in a medication error, may cause a resident slight discomfort or perhaps no discomfort at all.  However, if this omission leads to constipation that persists for greater than three days, the medication error may be deemed significant since constipation that causes an obstruction or fecal impaction can directly jeopardize the resident’s health and safety.

SOM, app. PP, Tag F760.  The term “jeopardize” is not defined in the SOM.  The common meaning of “jeopardize” is “to expose to danger or risk” or to “imperil.”23

The Board has stated that it is not necessary for CMS to show that there was any actual harm to support a conclusion that a medication error is significant.  Rather, a medication error may be significant if there is a potential danger or risk to a resident’s health and

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safety.  Life Care Ctr. of Tullahoma, DAB No. 2304 at 35 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sebelius,453 F. App’x 610 (6th Cir. 2011).  Discomfort may depend upon the individual resident.  The relative significance of medication errors is a matter of professional judgment that considers three factors:  (1) resident condition; (2) drug category; and (3) frequency of the error.  Id. at 36 (citing 56 Fed. Reg. 48,853 (Sep. 26, 1991)).  Similarly, the SOM provides that determining the relative significance of a medication error “is a matter of professional judgment” and directs surveyors to consider in assessing whether a medication error was significant or not, the resident’s medical condition, the drug category a medication fits within, and the frequency with which the error occurred.  SOM, app. PP, Tag F760.

Surveyor Rundle alleges in the SOD for the complaint investigation completed on May 3, 2022, that Petitioner violated 42 C.F.R. § 483.45(f)(2) (Tag F760) and the violation caused actual harm (scope and severity level of G) to Resident 1.  Surveyor Rundle specifically alleged that Petitioner failed to adequately monitor Resident 1’s blood sugar level prior to the administration of insulin to ensure the insulin dosage was appropriate to prevent high blood sugar levels, that caused Resident 1 to be hospitalized on March 31, 2022 and April 27, 2022 due to high blood glucose levels.  CMS Ex. 4 at 6-9.  Surveyor Rundle opined that the medication error was significant because Resident 1 was twice admitted to the hospital with high blood sugar levels.  CMS Ex. 86 at 18 ¶ 19V.  Surveyor Rundle explained in her declaration that she found that Petitioner’s staff was administering insulin to Resident 1 without first checking his blood glucose levels because she could not find documentation of an order to monitor his blood glucose, documentation of such monitoring, and because she was told by a nurse practitioner that  Resident 1’s blood glucose was not being checked before he was given insulin.  CMS Ex. 86 at 18 ¶ 19O, Q.  She also testified it was standard of care to check blood sugar levels before administering insulin of a resident with Type 1 diabetes like Resident 1.  CMS Ex. 86 at 18 ¶ 19U.

I conclude that the evidence is sufficient to satisfy the requirement for CMS to make a prima facie showing of a violation of 42 C.F.R. § 483.45(f)(2) based on a significant medication error in the case of Resident 1 and the violation posed a risk for more than minimal harm and constituted noncompliance for the period August 28, 2021 through April 10, 2022, based on the following facts.

Resident 1 was admitted to Petitioner August 28, 2021.  CMS Ex. 67 at 2.

An August 30, 2021, 6:44 p.m. progress note listed the following order for insulin:

Humalog U100 insulin, 100 unit/ml, five units administered subcutaneously every 6 hours; and

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Humulin R U500 insulin 100 unit/ml every six hours subcutaneously according to a sliding scale (I infer this to mean that the dose of the Humulin varied according to the resident’s blood sugar reading).

P. Ex. 17 at 2, 5 (emphasis added).

Resident 1’s October 6, 2021 care plan required monitoring the resident’s blood glucose according to the MAR and providing insulin per sliding scale parameters.  CMS Ex. 67 at 29 (emphasis added).   I find that the care plan was specific that the amount of insulin to be administered was to be determined using a sliding scale, which I infer was based on blood glucose readings for Resident 1.

But on April 11, 2022, a new order was issued with no reference to administering insulin for Resident 1 according to a sliding scale.  The order provided:

Novolin N NPH U100 insulin 10 units subcutaneous twice a day at 9:00 a.m. and 5:00 p.m.; and

Humulin N NPH U100 insulin 10 units subcutaneous twice a day at 9:00 a.m. and 5:00 p.m.

CMS Ex. 67 at 20; P. Ex. 17 at 52.

I conclude that Petitioner’s arguments that the SOD for the May 2022 survey alleged no medication error under Tag F760 (CMS Ex. 4 at 6-8) and that the resident’s blood glucose level were checked at appropriate times, are without merit as defenses or show that Petitioner was in substantial compliance under Tag F760.  P. Br. at 23-25; P. Reply at 7.

The analysis for the period August 28, 2021 through April 10, 2022, is straightforward.  The care plan and orders in effect during this period required that the resident’s blood glucose level was used to determine how much insulin to give him.  Because there is no evidence what the sliding scale in effect was for Resident 1 and no evidence that his blood glucose was regularly checked before an amount of insulin was administered, it is more likely than not that there was an error in the administration of insulin.  On March 31, 2022, the error, more likely than not, caused or contributed to the resident suffering actual harm and requiring hospitalization to address his high blood sugar.  Based on the events of March 31, 2022, I infer that any and all failures to measure the resident’s blood glucose before administering insulin according to a sliding scale was a daily significant medication error that jeopardized Resident 1’s health and safety posing a risk for more than minimal harm during the period August 28, 2021 through April 10, 2022.

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But on and after April 11, 2022, pursuant to the order issued on that date, the dose of insulin to be administered to Resident 1 was no longer determined from a sliding scale based on a blood glucose reading.  While I accept Surveyor Rundle’s opinion, it is standard of care to check a resident’s blood sugar before administering insulin, I do not have evidence that shows that a medication error occurs if blood glucose is not checked and the dose of insulin, which is not dependent on a blood glucose reading, is delivered as ordered by the resident’s physician.  Accordingly, after April 11, 2022, I do not accept that failure to check Resident 1’s blood sugar amounted to a medication error.24

Petitioner argues that its staff did not commit a significant medication error and, therefore, Petitioner did not violate 42 C.F.R. § 483.45(f)(2).  P. Br. at 23-25.  But Petitioner has not rebutted Surveyor Rundle’s opinion that it is standard of care to check the blood glucose level of a resident with Type 1 diabetes before administering insulin.  Petitioner has also failed to present evidence that it was more likely than not that its staff  regularly checked Resident 1’s blood glucose before administering insulin from August 28, 2021 through April 10, 2022, or that there was some other cause for the high blood glucose levels that caused his hospitalization on March 31, 2022.  P. Br. at 23-25; P. Reply at 7.  Although the finding of noncompliance I uphold is based specifically on the allegations in the SOD of which Petitioner had notice, I find that Petitioner’s records for Resident 1 in evidence could be the basis for findings of other failures to monitor and ensure proper administration of insulin between Resident 1’s admission and March 31, 2022, and failure to update his care plan to address changes in his diabetes management.  For example, the nurse practitioner note from March 4, 2022, at 2:10 p.m. indicates that blood glucose checks for the resident were mostly less than 150 mg/dl, but increasing highs were being noted.  P. Ex. 17 at 31.  But there is no evidence that the interdisciplinary team responsible for Resident 1’s care planning (42 C.F.R. §§ 483.20(d), 483.21(b)(2)(ii)) considered and addressed the trend before April 11, 2022.  Further, there is no evidence that the resident’s October 6, 2021 care plan addressing his diabetes and administering insulin on a sliding care was ever updated.  CMS Ex. 67 at 29.  But, of course, these examples are also not medication errors.

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I conclude that CMS has made a prima facie showing of noncompliance under Tag F760.  The evidence shows that Petitioner committed a medication error that caused Resident 1 to suffer discomfort and jeopardized his health and safety as evidenced by the fact he had to be hospitalized on March 31, 2022.  Therefore, I find that 42 C.F.R. § 483.45(f)(2) was violated.  Furthermore, the regulatory violation posed a risk for more than minimal harm and amounted to noncompliance under Tag F760.  Therefore, Petitioner bears the burden to rebut the prima facie showing or to establish an affirmative defense by a preponderance of the evidence.  I conclude that Petitioner has failed to satisfy its burden.

21.  Petitioner failed to specifically address nine allegations of noncompliance from the March 2022 and April 2022 surveys.  Petitioner did not waive its dispute regarding those allegations.  But the documentary evidence including the SODs and surveyors’ declarations establish prima facie showings of noncompliance that Petitioner has failed to address, failed to rebut, and for which Petitioner failed to establish an affirmative defense.

Petitioner requested review of the fifteen citations of noncompliance from the March, April, and May surveys in its request for hearing.  But Petitioner did not address in detail in its briefing the following nine allegations of noncompliance from the March and April surveys.  Petitioner’s failure to brief is not treated as a waiver of a challenge to those allegations of noncompliance.  Petitioner explains in both its brief and reply that its goal is to rebut only the most serious deficiencies, specifically Tags F686,25 F841, F882 from the March 10, 2022 survey, and Tags F692, and F760 from the May 3, 2022 survey, because it believes if it prevails on one or more of these allegations of noncompliance it will require reassessing the CMP to a lesser amount even if noncompliance is found under the Tags not specifically addressed by Petitioner in briefing.  P. Br. at 1, 3-4; P. Reply at 1-3.  The August 9, 2022 initial determination makes clear that CMS imposed a CMP based on all survey findings.  CMS Ex. 12 at 1-2.  CMS is not required to state how much weight was given to each citation of noncompliance in arriving at the CMP and DPNA, and the weight assigned by CMS is not subject to my review.  The issue before me is whether there is noncompliance that provides a basis for the imposition of an enforcement remedy.  Even if I found for Petitioner on each finding of noncompliance it specifically addresses in briefing, CMS still has a basis for the imposition of an enforcement remedy based on the other citations of noncompliance and the only question would be whether the CMP proposed should be reduced by some amount to be

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reasonable.  42 C.F.R. §§ 488.430(a), 488.438(e); Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14–16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).  However, in this case, Petitioner has not met its burden to rebut the findings of noncompliance it specifically addressed in briefing.

This decision discusses in detail only the allegations of noncompliance briefed by Petitioner.  The alleged noncompliance not specifically briefed by Petitioner is discussed because it is considered in determining the reasonableness of the enforcement remedies, but not in significant detail as detailed discussion is unnecessary to support my conclusions of law.  I conclude that for each allegation of noncompliance not specifically briefed by Petitioner, CMS made a prima facie showing of noncompliance based on the allegations of the SOD; the declarations of the surveyors (whose qualifications to render the opinions they render are sufficiently established for the record); and the documentary evidence in the record referred to by the surveyors in their declarations.  Petitioner has failed to rebut the CMS prima facie showing as to any of those allegations of noncompliance in addition to failing to rebut the noncompliance for the allegations of noncompliance under the Tags discussed in detail.

March 10, 2022 Survey

Tag F676 – CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.24(a)(1), (b) by failing to provide Resident 45 appropriate care and services to maintain or improve her ability to carry out activities of daily living (ADLs) specifically her mobility, by not getting her out of bed and sitting in a wheelchair.  CMS Ex. 2 at 1-4.  Petitioner does not dispute that on March 7, 2022, Surveyor Mendoza observed that Resident 45 requested to get out of bed and into her wheelchair.  Surveyor Mendoza states in the SOD that on March 8, 2022, she discovered that Resident 45 had not been transferred to her wheelchair after requesting assistance on March 7, 2022.  CMS Ex. 82 at 2-4 ¶ 8.  Petitioner does not present evidence that shows it was more likely than not that Surveyor Mendoza’s finding that the resident was not transferred to her wheelchair on March 7, 2022, was in error.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.

Petitioner argues in its prehearing brief that Resident 45 had a history of refusing to get out of bed.  The evidence shows it was more likely than not true that Resident 45 resisted being gotten out of bed to be placed in her wheelchair.  P. PHB at 4-6.  But Petitioner fails to rebut the CMS prima facie case based on this argument.  The evidence shows that nurse practitioners, restorative staff, and nursing staff agreed and understood that Resident 45 needed to get out of bed and sit in her wheelchair.  But the frequency and duration of Resident 45’s wheelchair sitting is not specified in the assessments, care plans, or progress notes in

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evidence.  Petitioner has not presented evidence showing regular efforts to get Resident 45 to sit in her wheelchair or how staff addressed the resident’s refusals other than by repeatedly advising the resident it was important to sit in her wheelchair.

Resident 45 received a restorative assessment August 17, 2021.  The assessment form indicates that she required extensive to total assistance of staff to transfer to her wheelchair.  The narrative states the resident could not voluntarily transfer out of bed and required the use of a lift for transfers.  P. Ex. 1 at 15-16,20.  Resident 45 received a restorative assessment November 3, 2021.  Resident 45 could not self-transfer to a wheelchair.  P. Ex. 1 at 8-9, 13.  Resident 45 was subject to a restorative assessment on January 6, 2022, and it was recorded that she could not perform a self-transfer to her wheelchair.  P. Ex. 1 at 1-2, 6; CMS Ex. 17 at 98.

Petitioner had a care plan for Resident 45 beginning November 3, 2021, that addressed ADL function and rehabilitation potential.  The care plan did not address having Resident 45 sitting in her wheelchair.  P. Ex. 1 at 23-27; CMS Ex. 17 at 49-57.  Petitioner also had a care plan for Resident 45 starting August 2, 2021, that addressed the resident’s behavioral symptoms including refusing to cooperate with catheter care, wound care, repositioning, refusing showering, and refusing weighing.  The care plan interventions were education and encouragement.  The care plan indicated that the intervention of using flowsheets to track mood and behavior was not applicable.  P. Ex. 1 at 28; CMS Ex. 17 at 13.

Nurse practitioner notes from February 8 and 22, and March 1, 2022, address the need for Resident 45 to get out of bed to relieve pressure on her backside to avoid skin breakdown.  The nurse practitioner noted that staff reported that Resident 45 continued to resist getting our bed and repositioning.  The nurse practitioner directed staff to encourage Resident 45.  P. Ex. 1 at 31-33, 36; CMS Ex. 17 at 79-83, 86-97. A nurse practitioner note from March 8, 2022, indicates that the nurse practitioner explained to Resident 45 the importance of frequent repositioning and moving out of her bed to relieve pressure on her backside.  CMS Ex. 17 at 75.  The nurse practitioner received a call from staff on March 8, 2022, to report the resident was out of bed for 15 minutes and wanted to go back to bed because she was tired and the nurse practitioner approved that request.  P. Ex. 1 at 37.

Nurse progress notes from February 24 and 28, 2022, show that the resident was not repositioning herself; she declined staff assistance with repositioning; and she was educated on the importance of repositioning every two hours.  CMS Ex. 17 at 83, 85.  A nurse progress note dated March 1, 2022, indicates that Resident 45 was not repositioning herself and resisting staff assistance to reposition.  The nurse noted she educated Resident 45 on the need to reposition every two hours to avoid skin breakdown.  P. Ex. 1 at 29; CMS Ex. 17 at 77.  A nurse progress note dated

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March 4, 2022, indicates the resident was not repositioning herself and she refused to get out of bed.  CMS Ex. 17 at 76.  A nurse note dated March 3, 2022, indicates the resident was not repositioning herself and declined staff assistance.  CMS Ex. 17 at 77.

Restorative nursing time records for March 3 through 10, 2022, show that restorative nursing provided bed mobility and active range of motion.  P. Ex. 1 at 21-22.  There is no record in evidence of time the resident was out of bed in her wheelchair; assistance provided by staff in ensuring the resident got out of bed and sat in her wheelchair; of regular training the resident received related to getting out bed; or a record of regular refusals of the resident to get out of bed and into her wheelchair; and interventions attempted to address that behavior.

Accordingly, I conclude Petitioner failed to rebut the CMS prima facie showing that there was noncompliance.

Tag F677 – Petitioner violated 42 C.F.R. § 483.24(a)(2) by failing to provide to four residents timely incontinence care which was a necessary service.  The SOD alleges that Petitioner failed to provide timely incontinence care to Residents 21, 55, 113 and 114, who were unable to carry out toileting activities.  CMS Ex. 2 at 4-7.  Surveyor Harris observed the soiled bed sheets of Residents 21, 113, and 114, and that Resident 55 did not receive incontinence care for more than eight hours when her regular Certified Nursing Assistant was not working.  CMS Ex. 80 at 4-6 ¶ 11.  Surveyor Harris’ observations are unrebutted.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

Tag F684 – Petitioner violated 42 C.F.R. § 483.25 by failing to ensure residents received treatment and care in accordance with professional standards of practice.  The SOD alleges that Petitioner failed to follow its policy of infection control related to disinfecting resident care equipment by failing to disinfect medical equipment between uses with different residents.  CMS Ex. 2 at 7-10.  Surveyor Harper observed Petitioner’s staff failed to disinfect the thermometer, blood pressure cuff, pulse oximeter, and glucometer before or after each use when taking the vitals of Residents 24, 34, 65, and 290, who were on isolation with contact and droplet precautions.  CMS Ex. 85 at 4-5 ¶ 10.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

Tag F755 – Petitioner violated 42 C.F.R. § 483.45(a)-(b) by failing to provide accurate pharmaceutical services to meet its residents’ needs.  The SOD alleges that Petitioner failed to ensure medications were available during medication

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administration per physician orders for Residents 65, 289, and 290, failed to properly document medication administration of controlled substances for residents 1, 71, 90 and 133, and failed to properly document shift change accountability for controlled substances per facility policy.  CMS Ex. 2 at 24-31; CMS Ex. 85 at 9-12 ¶¶ 12-13.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

Tag F759 – Petitioner violated 42 C.F.R. § 483.45(f)(1) by failing to ensure that its medication error rate was not five percent or greater.  The SOD alleges that there were three medication errors out of twenty-five medication opportunities observed, resulting in a 12 percent medication error rate.  CMS Ex. 2 at 31-34.  Surveyor Harper observed an RN failing to administer 25 mg of Seroquel® to Resident 65 via g-tube as prescribed, administering crushed enteric-coated aspirin via g-tube instead of chewable aspirin to Resident 290 as prescribed, and failing to administer two tablets of 10 mg of famotidine to Resident 289 via g-tube as prescribed.  CMS Ex. 85 at 12-13 ¶ 14.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

Tag F761 – Petitioner violated 42 C.F.R. § 483.45(g)-(h) by failing to properly label and store drugs and biologicals.  The SOD alleges that Petitioner failed to remove food items from the medication freezer, maintain the medication refrigeration temperature log by recording temperatures daily, appropriately date open insulin pens and multi-dose vials, and ensure inhalers are labeled with the resident’s name for Residents 4, 28, 104, 105, and 127.  CMS Ex. 2 at 34-39.  Surveyor Harper observed no entries for March 2022 in the temperature logs for the third and fourth floor medication room refrigerators as of March 7, 2022, a frozen dinner was in the third-floor medication refrigerator, and neither of Resident 127’s inhalers were labeled with Resident 127’s name.  CMS Ex. 85 at 13-15 ¶¶ 16-18.  Surveyor Pardo observed opened insulin vials for Residents 4, 28, 104, and 105 that were not labeled with the open or expiration dates, and staff were unable to provide documentation of the open or expiration dates.  CMS Ex. 84 at 3-4 ¶ 9.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

April 19, 2022 Survey

Tag F607 – Petitioner violated 42 C.F.R. § 483.12(b)(1)-(3) by failing to develop and implement written policies and procedures to prohibit and prevent abuse, neglect, misappropriation of resident property, and exploitation.  Petitioner failed to follow, i.e., implement, its abuse prevention policy (CMS Ex. 62) by

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immediately removing a staff member from resident contact after an allegation of abuse was made by Resident 7.  CMS Ex. 3 at 1-4.  Surveyor Rundle discovered that, on March 9, 2022, Resident 7 alleged inappropriate contact by a male respiratory therapist but he continued working at the facility until he clocked out approximately three hours after the Administrator was made aware of the incident.  CMS Ex. 86 at 4-5 ¶ 13.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

Tag F684 – Petitioner violated 42 C.F.R. § 483.25 by failing to ensure residents receive treatment and care in accordance with professional standards of practice.  Petitioner failed to ensure all nursing staff were able to provide care for Resident 10, who wore an external defibrillator vest due to a history of sudden cardiac arrest.  CMS Ex. 3 at 4-10.  Resident 10 was transferred to the hospital on March 31, 2022 with no battery power to his defibrillator vest and without the docking station.  CMS Ex. 3 at 5; CMS Ex. 53 at 34.  Surveyor Rundle observed that Resident 10’s defibrillator vest’s placement and batteries were not checked in accordance with the manufacturer’s guide or physician’s orders and Petitioner’s staff failed to ensure that the battery for the defibrillator was charged at all times.  CMS Ex. 86 at 6-8 ¶¶ 14.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

Tag F726 – Petitioner violated 42 C.F.R. § 483.35(a)(3) and (c) by failing to ensure through its training program that it had sufficient and proficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to care for Resident 10, who wore a defibrillator vest.  CMS Ex. 3 at 18-22.  Surveyor Rundle observed that the manufacturer’s guide for Resident 10’s defibrillator vest required specific training and understanding of the system but that of the 41 members of the nursing staff assigned to Resident 10’s floor, only 29 had attended the in-service training regarding the vest, and that the training failed to use demonstrative props or test the knowledge of the attendees.  CMS Ex. 86 at 12-13 ¶ 17.  The surveyors found that the regulatory violation posed a risk for more than minimal harm and that finding has not been rebutted.  Accordingly, I conclude that there was noncompliance.

22. A CMP of $1,537.25 per day for 111 days of noncompliance from January 29, 2022, through May 19, 2022, for a total CMP of $170,634.75, is reasonable.

Based on my findings of fact and analysis, I conclude that CMS made a prima facie showing that Petitioner was not in substantial compliance with participation requirements due to regulatory violations that posed a risk for more than minimal harm and amounted

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to noncompliance for at least the period for which CMS proposed enforcement remedies – January 29 through May 19, 2022.  Petitioner has not rebutted the CMS prima facie showing or established an affirmative defense as to the allegations of noncompliance by a preponderance of the evidence.  Nor has Petitioner shown that the scope and severity levels determined by the surveyors and alleged by CMS were clearly erroneous.  I further conclude for the following reasons that the proposed CMP and the DPNA from April 5 through May 19, 2022, are reasonable enforcement remedies.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per day CMP for the number of days that the facility is not in compliance.  42 C.F.R. § 488.430(a).

When the surveys and complaint investigations were conducted between March 10 and May 3, 2022, and the initial determination was issued on August 9, 2022, CMS was authorized to impose a per day CMP in the lower range of CMPs of $120 to $7,195 per day for noncompliance that did not pose immediate jeopardy.  42 C.F.R. §§ 488.408(d); 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2022).

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of non-compliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as described in 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety – the absence of culpability is not a mitigating factor.

The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.

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My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  Emerald Oaks, DAB No. 1800 at 10; CarePlex of Silver Spring, DAB No. 1683 at 14–16; Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629.

I have considered the regulatory factors.

Pursuant to 42 C.F.R. § 488.438(f)(1), I consider Petitioner’s history of noncompliance including any repeated deficiencies.  CMS argues that Petitioner has a history of noncompliance including prior to the survey cycle that began on March 10, 2022, and between the March 10 and April 19, 2022 surveys which both cited noncompliance under Tag F686.  CMS Exs. 2 at 11-24, 3 at 10-18.  I do not consider the noncompliance cited by the survey and complaint investigations during the survey cycle that began March 10, 2022, as a history of noncompliance as that noncompliance is presently before me for adjudication.  The noncompliance identified in Petitioner’s prior enforcement history shows a history of noncompliance under Tags F686 and F684 from surveys in 2019, 2020, and 2021.  CMS Ex. 7 at 2, 5, 7.  But only the citation of noncompliance under Tag F684 from the survey cycles of September 9, 2021 and January 19, 2021, resulted in the imposition of an enforcement remedy.  Consistent with my evidentiary ruling, I only consider in assessing the reasonableness of the enforcement remedy in this case, prior noncompliance that resulted in the imposition of an enforcement remedy as evidence that the state agency or CMS considered that prior noncompliance serious.

Petitioner argues that it had significant lost revenue due to the DPNA and it will struggle to pay a CMP.  P. Br. at 26; P. Reply at 7; P. Ex. 19.  CMS has already granted Petitioner a financial hardship reduction of the originally proposed CMP totaling $262,515 by reducing it 35 percent to the proposed total CMP I review of $170,634.75.  Jt. Stip. at 3 ¶ 15.  The CMS hardship reduction was granted upon the same information Petitioner submitted to me in P. Ex. 19.  I have considered the amount of the reduced CMP, the possible impact of the DPNA upon Petitioner’s revenue, and all the other information contained in Petitioner’s hardship request (P. Ex. 19) but conclude reduction based on financial hardship in addition to that already granted by CMS is not warranted.

Petitioner argues that the CMP is larger than it should be due to the extended periods between the three surveys.  P. Br. at 26.  The survey and investigations in this case were conducted during a period of less than three months from March 10 through May 3, 2022.  CMS Exs. 2-4.  Petitioner alleged in its plan of correction for the March 10, 2022 survey that it corrected the noncompliance as of April 4, 2022.  CMS Ex. 2 at 1.  The next survey occurred only 15 days later, on April 19, 2022.  Petitioner alleged in its plan of correction for the April 19, 2022 survey that it corrected the noncompliance as of May 5,

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2022 -- two days after the May 3, 2022 survey was completed.  CMS Ex. 3 at 1.  Petitioner alleged in its plan of correction for the May 3, 2022 survey that it corrected the noncompliance on May 20, 2022, and based on the June 13, 2022 revisit survey, the state agency and CMS determined that Petitioner returned to substantial compliance as of May 20, 2022.  CMS Ex. 5.  My review of the timing of the three surveys and inspections leads me to conclude that the amount of time between surveys was not unreasonable given Petitioner’s allegations of when it corrected noncompliance and the fact CMS found Petitioner returned to substantial compliance effective the date Petitioner said it corrected the noncompliance cited by the May 2022 survey.  Petitioner also cites no statutory or regulatory authority or any policy of CMS that would have required the state agency or CMS to act more expeditiously than it did in this case.

I consider that the deficiencies cited in the three surveys/investigation were serious.  I consider particularly serious the noncompliance that caused actual harm to Residents 5 and 28 (Tag F686, March 2022 survey) and Resident 1 (Tags F692 and F760, May 2022 survey).  Petitioner argues that there was no noncompliance that caused actual harm to any residents.  P. Br. at 10, 25; P. Reply at 3.  But Petitioner is in error.  Petitioner’s assertion that there was no actual harm is inconsistent with the evidence and rejected for the reasons already discussed under Tags F686 and F760.  Even if actual harm did not occur due to other noncompliance, the seriousness of noncompliance is not measured solely by whether a resident suffered actual harm.  The evidence shows that there were instances when care and services were not provided to residents as ordered.  Errors were committed by multiple staff.  Petitioner’s deficiencies under Tags F841 and F882 had the potential to affect all of the facility’s residents because there was no medical director responsible for implementing resident care policies, and Petitioner did not have an infection preventionist with the required specialized training in infection prevention and control.

I conclude that Petitioner was culpable.  The regulation provides a non-exhaustive list of what constitutes culpability, including “neglect, indifference, or disregard for resident care, comfort or safety.”  42 C.F.R. § 488.438(f)(4).  Neglect is “failure . . . to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.”  42 C.F.R. § 488.301.  I have found and concluded that Residents 1, 5, and 28 suffered actual harm.  The harm that they suffered was due to failure of Petitioner’s staff to deliver necessary care and services to prevent and treat Resident 28’s pressure ulcers, to treat Resident 5’s pressure ulcer, and to provide Resident 1 with adequate nutrition and check his blood sugar before administering insulin.  Petitioner’s noncompliance meets the definition of neglect and the evidence shows a disregard for the residents’ care, comfort, and safety.

The per day CMP of $1,537.25 proposed by CMS is only 21.4 percent of the maximum authorized per day CMP of $7,195.  Based on my review of the regulatory factors, I

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conclude that a per day CMP of $1,537.25 for 111 days of noncompliance from January 29 through May 19, 2022, is reasonable.  The DPNA is also reasonable.

III.  Conclusion

For the foregoing reasons, I conclude that:

Petitioner was not in substantial compliance with program participation requirements from January 29 through May 19, 2022, due to multiple regulatory violations, each of which posed a risk for more than minimal harm to residents; and

Reasonable enforcement remedies are a CMP of $1,537.25 from January 29 through May 19, 2022, for a total CMP of $170,634.75, and a DPNA from April 5 through May 19, 2022.