Resorts at Chester River Manor Corp., DAB CR6628 (2025)

DECISION

Petitioner, Resorts at Chester River Manor Corp., was not in substantial compliance with program participation requirements from October 19 through December 15, 2020, due to violations of 42 C.F.R. §§ 483.20(g); 483.21(b)(1); 483.25(b)(1); 483.25(d); 483.25(g)(1); 483.25(i); 483.35(a), (c); 483.70(i)(1), (5); and 483.80(a).  Each regulatory violation posed a risk for more than minimal harm and amounted to noncompliance.1 A reasonable enforcement remedy is a civil money penalty (CMP) of $1,300.00 per day for the period October 19 through December 15, 2020, a total CMP of $75,400.

I.  Background

Petitioner is a skilled nursing facility (SNF) participating in Medicare and a nursing facility (NF) participating in Medicaid.  Petitioner is in Chestertown, Maryland.  On October 28, 2020, the Maryland Office of Health Care Quality, Long Term Care Unit (state agency) completed an abbreviated survey of Petitioner and cited 12 violations of

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Medicare participation requirements.  Joint Stipulation of Facts (Jt. Stip.) ¶¶ 1-5.  The Centers for Medicare & Medicaid Services (CMS) notified Petitioner on June 25, 2021, of its initial determination to impose a CMP of $1,300 per day for the period October 19 through December 15, 2020, a total CMP of $75,400, based on the noncompliance alleged by the state agency.  CMS also advised Petitioner that the state agency conducted a revisit survey and had determined Petitioner returned to substantial compliance on December 16, 2020.  Jt. Stip. ¶ 6; CMS Exhibit (Ex.) 2.

Petitioner requested a hearing (RFH) before an administrative law judge (ALJ) on July 13, 2021.  The case was assigned to me for hearing and decision on July 16, 2021, and an Acknowledgment Letter and Standing Order were issued at my direction.

On October 12 and 14, 2021, CMS filed CMS Exs. 1 through 17.  On December 16, 2021, Petitioner filed Petitioner’s exhibits (P. Exs.) 1 through 23.

A hearing was convened on November 28, 29, and 30, 2023, and a transcript (Tr.) was prepared.  CMS Exs. 1 through 14, 16, and 17 were admitted as evidence and CMS withdrew CMS Ex. 15.  Tr. 30-39.  P. Exs. 1 through 9, 12 through 23 were admitted as evidence.  Petitioner withdrew P. Exs. 10 and 11.  Tr. 39-57.  CMS called Surveyor Margaret Crosby, RN to testify at the hearing.  Petitioner called the following witnesses: Symphorienne Tawali, GNA (Geriatric Nursing Assistant); Gary Sprouse, MD; Mary Parlett, RN (Registered Nurse), Petitioner’s Assistant Director of Nursing (ADON); and Sharon Jones, RN, Petitioner’s Director of Nursing (DON).

CMS and Petitioner filed post-hearing briefs (CMS Br. and P. Br. respectively) on April 8, 2024.  CMS filed a reply brief (CMS Reply) on May 20, 2024.  Petitioner filed a reply brief (P. Reply) on June 10, 2024.  CMS filed with its post-hearing brief Appendices A through G.  Appendices A through D, F, and G are not treated as substantive evidence but are considered demonstrative evidence submitted in support of the arguments advanced by CMS in its brief.  Petitioner objects to my consideration of Appendix E submitted with CMS’s post-hearing brief.  P. Reply at 5 n.2.  Appendix E was clearly submitted by CMS with its post-hearing brief for the purpose of attacking the character and credibility of Petitioner’s witness, Gary Sprouse, MD, or to rebut his testimony.  CMS Br. at 21.  CMS did not offer the evidence contained in Appendix E during the development of the case for hearing or as a rebuttal exhibit at hearing.  Therefore, Petitioner was deprived, for example, of the opportunity to challenge or clarify the evidence or otherwise offer evidence of the witness’s character for truthfulness.  See e.g., Fed. R. Evid. 608(b).  CMS requests that I take judicial notice of the official records of the Maryland Board of Physicians.  However, taking judicial notice without reopening the hearing would deprive Petitioner of the opportunity to attempt to rebut the evidence and rehabilitate Dr. Sprouse, to the extent Petitioner may deem necessary.  Petitioner listed Dr. Sprouse on its witness list filed December 16, 2021, nearly two years prior to hearing.  Therefore, CMS had ample opportunity to develop and offer evidence to attack Dr. Sprouse’s character and

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credibility prior to hearing or as rebuttal at hearing.  CMS lack of preparation is not grounds to reopen the hearing.  Rather, the information in Appendix E to the CMS post-hearing brief is simply not considered for any purpose.  Appendix A is an extract from CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities, Tag F689.  The current SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984 (last accessed Jan. 20, 2025).  The SOM contains CMS policy based on its interpretation of the act and regulations.  The SOM does not have the force and effect of law.  But provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary of Health and Human Services (Secretary) may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.  Appendix A reflects that the version of Tag F689 was effective October 21, 2022, nearly two years after the survey in this case.  Therefore, that version of F689 is not relevant and not considered for any purpose.  Appendix B is SOM Tag F692 that was effective November 28, 2017.  Appendix B reflects CMS policy in effect at the time of the survey and it is considered.  Appendix C is a helpful matrix that summarizes evidence, and it is considered for that purpose.  Appendix D is a blank Minimum Data Set (MDS) form offered to facilitate understanding of CMS Ex. 16 and it is considered for that purpose only.  CMS Br. at 17 n.20.  Appendix F is an extract from the SOM for Tag F686 that was not effective until October 21, 2022, two years after the survey and for that reason not relevant or considered.  Appendix G is a copy of a Centers for Disease Control and Prevention article captured from a government website in April 2020, before the survey.  The title of the article is “Preparing for COVID-19:  Long-term Care Facilities, Nursing Homes.”  But Appendix G is not cited in CMS’s brief, and it is not considered further.

II.  Discussion

1. Applicable Law

1.  Statutory and Regulatory Medicare Program Enforcement

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act)2 and 42 C.F.R. pt. 483.  Section 1819(h)(2)

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of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failing to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act and 42 C.F.R. pt. 483. 

The Act requires the Secretary to terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months after the date the facility is found to be noncompliant.  Act § 1819(h)(2)(C).  The Act also requires the Secretary to 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 the date the facility is found to be noncompliant – commonly referred to as the mandatory or statutory DPNA (denial of payment for new admissions).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate noncompliant SNFs’ 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, CMPs, appointment of temporary management, and other remedies such as 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 long-term care facility that is not complying substantially with federal participation requirements.  “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.  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.  Noncompliance refers to any deficiency (statutory or regulatory violation) that causes a facility to be not in substantial compliance, i.e., 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.  42 C.F.R. §§ 488.400 (Act authorized Secretary to impose enforcement remedies when facility is not in substantial compliance), 488.402(b) (enforcement remedies are applied based on noncompliance), 488.408(g)(1), 498.3(b)(13) (facility may only request review of a certification of noncompliance for which an enforcement remedy is imposed).

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.

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Generally, CMS is authorized to impose a CMP against a facility not in substantial compliance with a program participation requirement.  The regulations specify that a per-day CMP imposed against a facility will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,808 to $22,320 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents, and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).  “Immediate jeopardy means a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  The lower range of a CMP, $112 to $6,695 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  CMS is also authorized to impose a per-instance CMP in the range of $2,233 to $22,320.  42 C.F.R. § 488.438(a)(1)(ii), (2); 45 C.F.R. § 102.3 (Table) (2020).

2.  Limited Right to Review of a Determination to Impose an Enforcement Remedy

The Act and regulations give long-term care facilities against which CMS has imposed an enforcement remedy the right to a hearing before an ALJ.  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 nurse aide training and competency evaluation program.  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. 2003).  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).

3.  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).

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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.3 Rather, the Board has long held that the petitioner, i.e., the nongovernmental party, 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.  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 (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

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authority) to establish a prima 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 a 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 must present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that CMS must support its prima facie case by preponderant evidence, or what happens if it has not, including whether the burden shifts to Petitioner or not.  It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.

I conclude that CMS made a prima facie showing of noncompliance in this case.  Petitioner has not rebutted the CMS prima facie showing of noncompliance.

2. Issues

The issues in this case include the following:

Whether Petitioner was in substantial compliance with the Medicare participation requirements.

Whether there is a basis for the imposition of an enforcement remedy and, if so, what is the reasonable enforcement remedy.

3. Conclusions of Law

The following numbered conclusions of law are based on my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.4  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

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be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

Alleged Noncompliance at Issue

Not all the instances of noncompliance alleged by the surveyors in the Statement of Deficiencies (SOD) for the survey that ended on October 28, 2020, are at issue before me.

The surveyors cited Petitioner for the following noncompliance:

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CMS Ex. 1.

CMS advised me at the hearing that it was not proceeding on Tag F693 the alleged violation of 42 C.F.R. § 483.25(g)(4) – (5) and Tag F760 the alleged violation of 42 C.F.R. § 483.45(f)(2).  Tr. 59.  Those allegations of noncompliance are not considered further.

Accordingly, the allegations of noncompliance under Tags F693 and F760 are not at issue.  The allegations of noncompliance under Tags F641, F656, F686, F689, F692, F695, F711, F726, F842, and F880 are at issue before me.  However, my discussion begins with Tags F689 and F692 as those are the Tags CMS asserts weighed most heavily in the determination of the amount of the CMP imposed.  CMS Br. at 1-2

1.  Petitioner violated 42 C.F.R. § 483.25(d) (Tag F689).

2.  Petitioner’s violation of 42 C.F.R. § 483.25(d) posed a risk for more than minimal harm and amounted to noncompliance.

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.

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(a)  Findings of Fact

Resident 7, a female, was 73 years old at the time of the survey.  She was initially admitted to Petitioner in February 2013 and readmitted on October 17, 2015.  Her diagnoses included left-side weakness or paralysis due to cerebrovascular disease, contractures of her left and right knees, major depression, uncontrollable episodes of crying or laughing, difficulty speaking and swallowing due to intracerebral hemorrhage (stroke) or cerebrovascular disease, dementia, convulsions, anxiety, type 2 diabetes mellitus, generalized muscle weakness, hypertension, hyperlipidemia, muscle wasting and atrophy, among others.  CMS Ex. 6 at 1-2, 28, 31.

A care plan for Resident 7, revised May 21, 2014, indicated that Resident 7 could engage in physical behaviors and agitation due to her dementia.  A care planned intervention dated February 28, 2013, instructed that, when Resident 7 became agitated, staff should intervene before the agitation escalated, Resident 7 should be guided away from the source of any distress, she should be engaged calmly in conversation, and, if Resident 7 responded aggressively, staff should walk away calmly and approach her later.  CMS Ex. 6 at 11, 64.

Resident 7 had a fall care plan, initiated February 28, 2013, because she was at high risk for falls due to lack of safety awareness.  The fall care plan, which was revised on March 28, 2013 and September 26, 2017, required that when Resident 7 was in bed, her bed was to be in the lowest position and that floor mats were to be at the bedside.  After Resident 7 fell from her bed on September 26, 2020 (CMS Ex. 6 at 63), two interventions were added.  On September 28, 2020, an intervention was added that required a two-person assist as needed.  On September 30, 2020, an intervention was added that provided that if Resident 7 refused care, staff was to stop care until the resident was calm.  CMS Ex. 6 at 65; P. Ex. 15 at 2.7

Resident 7’s MDS dated September 4, 2020, 22 days before her fall from bed, shows Resident 7 was assessed as totally dependent on staff for bed mobility and transfers with the physical assistance of two or more staff.  She was assessed as totally dependent on staff for dressing, eating, and toilet use with the assistance of one staff member.  She was

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also totally dependent on staff for personal hygiene with the assistance of two or more staff.  CMS Ex. 6 at 40, 47; P. Ex. 6 at 13.

A progress note dated September 26, 2020, at 3:24 p.m., indicates Resident 7 fell from her bed while it was in the high position; a GNA witnessed the fall; Resident 7 was observed lying on the floor by her bed; there was a large amount of blood from her head; her right arm was distorted; she was alert but nonverbal; and she was transferred by ambulance to the hospital.  CMS Ex. 6 at 63.

There is no dispute that the surveyor obtained documents from Petitioner’s staff related to the fall of Resident 7 on September 26, 2020, which were placed in evidence by CMS subject to Petitioner’s hearsay objections.  Tr. 36; CMS Ex. 6 at 86-93.  One undated document indicates it is a timeline for the incident involving Resident 7’s fall.  CMS Ex. 6 at 86.  The timeline states that at approximately 2:00 p.m. on September 26, 2020, a GNA started to give Resident 7 a bed bath.  During the bed bath Resident 7 became combative when the GNA turned the resident from her right to left side.  The GNA calmed Resident 7 but then the resident began sliding off the air mattress headfirst with her head off the bed and her lower body still on the bed.  The GNA lowered the resident’s legs to the floor.  She noted bleeding from Resident 7’s head and summoned help.  At approximately 2:05 p.m. a nurse assessed Resident 7, administered first aid, and called for emergency medical services (EMS).  At approximately 2:25 p.m. on September 26, 2020, Resident 7 was transported to the hospital.  Resident 7 returned to the facility on September 27, 2020, at 8:56 a.m.  The timeline indicates Petitioner investigated and determined the Resident 7’s fall was unavoidable; the GNA did not need assistance when the bath began; Resident 7 became combative; and the GNA was unable to get assistance to prevent the fall.  The timeline indicates that the GNA received re-education on September 28, 2020, regarding decreasing falls, caring for residents with dementia, and behavior interventions.  CMS Ex. 6 at 86.

A document dated September 28, 2020, indicates it is the fall investigation for Resident 7.  The investigation states Resident 7 rolled out of bed during care and sustained a laceration to her left forehead.  The investigation also indicates, based on review of hospital records, that Resident 7 had an intracerebral hemorrhage and a right humerus (upper arm bone) dislocation due to the fall.  The investigation indicates statements were reviewed and the fall was reenacted.  Resident 7 was receiving care from a GNA and became combative as the GNA rolled the resident toward her.  Resident 7 started sliding off the bed headfirst and the GNA was unable to prevent the resident from falling off the bed by grabbing the resident’s waist and legs.  The GNA was unable to prevent the resident from hitting her head on the floor.  The GNA lowered the resident to the floor and raised and moved the bed.  The GNA was given in-service training on safe rolling of residents, and, if residents became combative during care, the GNA was instructed to stop care and get help or wait until the resident calmed.  CMS Ex. 6 at 88.

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Surveyor Crosby testified that CMS Ex. 6 at 86 and 90 were part of the investigation documents that Petitioner provided to her.  Tr. 134, 183.

A statement signed by GNA Tawali states that on September 26, 2020, she was giving Resident 7 a bed bath.  She states that she had the bed at her waist-level.  She states that Resident 7 started to fight her.  But she explained to the resident that she was there to take care of her.  According to GNA Tawali, Resident 7 then started to move her legs back and forth.  When GNA Tawali turned the resident to the resident’s left side to wash her back and bottom, the resident started to slide out of bed headfirst.  GNA Tawali states she tried to prevent the fall by grabbing the resident’s waist and legs but could not prevent her head from hitting the floor.  She lowered the resident’s legs to the floor.  She then raised the bed higher and pushed it out of the way and went for help.  CMS Ex. 6 at 90.  Petitioner submitted GNA Tawali’s affidavit.  GNA Tawali states in her affidavit that on September 26, 2020, Resident 7 became agitated while she was providing care.  She states she talked to Resident 7 who calmed down and was not agitated and then she began bathing the resident.  Resident 7 had soap on her back and began to slide and GNA Tawali states that she could not prevent her from sliding.  P. Ex. 1.  Petitioner presented an unsigned and undated document that purports to be a re-interview of GNA Tawali.  P. Ex. 2.  GNA Tawali identified the document at the hearing, testified that she recalled making the statement, and testified it accurately reflected her recollection of what happened to Resident 7 on September 26, 2020.  Tr. 216-18.  The re-interview of GNA Tawali states that on September 26, 2020, at 11:00 a.m. Resident 78 was fighting her as she attempted to change the resident.  GNA Tawali states in the re-interview she left the resident’s room at 11:30 a.m.  Subsequently, she re-entered Resident 7’s room and prepared to give her a bed bath.  She put the resident’s bed at waist-level.  She undressed the resident.  Resident 7 started moving her legs back and forth.  GNA Tawali thought Resident 7 was upset, so she spoke to the resident who stopped moving and was calm.  She washed the resident’s front then rolled her onto her left side.  GNA Tawali states her gloves were wet and the resident started moving her head back and forth.  Resident 7’s head started sliding off the bed.  GNA Tawali tried to lower the bed while holding the resident, but the resident fell between her and the bed to the floor.  She saw blood and went out the door to call for help.  She could not recall whether there was a floor mat.  GNA Tawali stated in the re-interview that she did not tell the surveyor that the resident was fighting while she was trying to give a bath but, rather, at 11:00 a.m. when she was trying to change the resident.  At the hearing, GNA Tawali identified CMS Ex. 6 at 90 as the statement she signed during Petitioner’s investigation of the incident.  She testified that when she wrote the statement, she was traumatized.  When she said that Resident 7 was fighting her, she did not mean physical fighting like punching and kicking.  The

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resident was squirming like she was trying to help and that is when the fall occurred.  Tr. 231-34.  She testified at the hearing that when she spoke to the surveyor, she did not mean to say that Resident 7 was physically fighting her.  What she intended to convey was that Resident 7 was squirming like she was trying to help get in the right position.  Tr. 219, 225.  Despite some inconsistencies in her various statements and testimony, I find GNA Tawali credible, and inconsistencies are generally consistent with the stress involved in the incident with Resident 7, stress associated with interrogation by the surveyor, miscommunication without clarification during the interview with the surveyor, and the stress of giving testimony at hearing.  I find her statement made nearest the time of the incident the most reliable because it was given when the details of the incident were fresh before outside influences may have affected her recollection and perspective.

The evidence includes a statement dated September 28, 2020, from Licensed Practical Nurse (LPN) Masten.  LPN Masten states she was the nurse called to assist with Resident 7.  When she arrived, she observed Resident 7 on the floor, naked, with her right arm distorted at her side, and with a large amount of blood coming from her head and on the floor.  GNA Tawali was present.  LPN Masten observed the bed was in the highest position.  She covered Resident 7, who was shivering, with a blanket.  She called for EMS who arrived at 2:25 p.m.  CMS Ex. 6 at 92.  LPN Masten’s name is listed on the progress note dated September 26, 2020, at 3:24 p.m. that recorded details of the incident.  CMS Ex. 6 at 63.

Summary of Key Facts

The preponderance of the evidence shows the following facts necessary to resolve the alleged noncompliance under Tag F689.

1.  On September 4, 2020, Petitioner determined based on an assessment of Resident 7, that she:

a.  Required two staff to assist her with bed mobility and transfers.

b.  Required two staff to assist her with personal hygiene including combing her hair, brushing her teeth, and washing and drying her face and hands, but not including baths and showers.

CMS Ex. 6 at 40, 47; P. Ex. 6 at 13.

2.  No evidence has been presented showing that between September 4 and 26, 2020, Resident 7’s condition changed so that she no longer required assistance of two staff for bed mobility and transfers and personal hygiene.

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3.  The evidence does not include an assessment by Petitioner of the number of staff required to assist in giving Resident 7 a bed bath.

4.  I infer, based on the facts that two staff were required for bed mobility and two staff were required for personal hygiene, that two staff should be required for a bed bath.

5.  The evidence does not include a care plan for Resident 7 that adopts interventions for giving Resident 7 a bed bath or delivering care while she was in bed, considering her identified fall risk and risk for agitation and physical behaviors.  CMS Ex. 6 at 65; P. Ex. 15 at 2

6.  No policy of Petitioner addressing safely giving a bed bath is in evidence.

7.  Resident 7 had a care plan to address the fact she could become aggressive, agitated, and engage in physical behaviors due to her dementia.  CMS Ex. 6 at 11, 64.

8.  Resident 7 had a fall care plan that required her bed be in the lowest position when she was in the bed.  CMS Ex. 6 at 13, 65; P. Ex. 15 at 2.

9.  Evidence related to Resident 7’s accident shows that:

a.  GNA Tawali was giving Resident 7 a bed bath on September 26, 2020.

b.  No one was assisting GNA Tawali with giving Resident 7 a bed bath.

c.  Resident 7 began moving her legs and head during the bed bath.

d.  Resident 7’s bed was at GNA Tawali’s waist level and not at the lowest level while the bed bath was being given.

e.  Resident 7’s head moved off the bed.

f.  GNA Tawali grabbed Resident 7’s waist and legs and lowered her to the floor.

g.  Despite her effort to hold onto Resident 7, Resident 7 hit her head and right shoulder or right arm on something.

h.  Resident 7 suffered injuries including a cut on her forehead, a dislocated humerus, and an intracerebral bleed due to the accident.

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CMS Ex. 6 at 86, 88, 90; P. Ex. 1; P. Ex. 2; Tr. 216-18, 231-34, 219, 225.

(b) Analysis

The Allegation of Noncompliance

Surveyor Crosby alleged in the SOD that Petitioner violated 42 C.F.R. § 483.25(d) because Petitioner failed to prevent Resident 7 from falling from her bed and Resident 7 suffered actual harm as a result.  CMS Ex. 1 at 24.  Surveyor Crosby alleges many facts in the SOD regarding the resident’s care plans and what she was told and read regarding Resident 7’s fall from bed on September 26, 2020.  CMS Ex. 1 at 24-29.  But she does not specifically allege that she concluded that Petitioner’s staff failed to follow Resident 7’s care plan or that there were other causes or contributing factors.  CMS Ex. 1 at 24.  Surveyor Crosby testified in her declaration that she participated in the complaint survey conducted at Petitioner from October 19 through 28, 2020.  She testified that she made the observations, conducted the staff interviews related to Tag F689, and wrote the SOD for Tag F689.  CMS Ex. 5 at 2-4 ¶¶ 4, 8-10.  In her declaration, Surveyor Crosby indicates that she found that Resident 7 became aggressive while receiving a bed bath and that GNA Tawali should have dried the resident, covered the resident, lowered the bed, and walked away.  CMS Ex. 5 at 5 ¶¶ 17-19; Tr. 126.  Surveyor Crosby also noted that Resident 7 had been assessed as requiring a two-person assist for bed mobility and that there was no evidence that floor mats were in place as required by the resident’s fall care plan.  CMS Ex. 5 at 5 ¶¶ 14-15.  CMS argues to me that GNA Tawali failed to follow Resident 7’s care plan that required staff to walk away from the resident if she became agitated and to ensure her bed was at the lowest position with floor mats in place.  CMS Br. at 2, 4, 6-11; CMS Reply at 2-7.

Participation Requirement of 42 C.F.R. § 483.25(d)

The participation requirement at issue is established by 42 C.F.R. § 483.25(d) which provides:

The facility must ensure that—

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

The Board has addressed the requirements of 42 C.F.R. § 483.25(d) in many decisions.

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In Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB No. 3036 (2021), the Board provided a thorough summary of its interpretation and application of the regulation.

Section 483.25 obligates a facility to make “quality of care,” as described in the regulation, a fundamental principle applicable “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 . . . the comprehensive person-centered care plan” and “the resident’s choices.”  Id. To that end, section 483.25(d)(1) (formerly section 483.25(h)(1)), . . . obligates a facility to provide a resident environment that is “as free of accident hazards as is possible.”  This requirement “places a continuum of affirmative duties” on the facility.  Maine Veterans’ Home - Scarborough, DAB No. 1975, at 6 (2005).  A facility must identify and remove hazards, where possible, or where the hazard is unavoidable because of other resident needs, manage the hazards by reducing accident risks to the extent possible.  Id. at 10; Meridian Nursing Ctr., DAB No. 2265, at 3 (2009), aff'd sub nom. Fal-Meridian, Inc. v. United States Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010).  In accordance with section 483.25(d)(2), a facility must take “all reasonable steps to ensure that a resident receives supervision . . . that meet[s] his or her assessed needs and mitigate[s] foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115, at 5 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)).

“[T]he federal requirements are based on an ‘outcome-oriented’ approach, in which the regulations establish outcomes facilities must achieve, but provide each facility with flexibility to select methods to achieve them that are appropriate to its own circumstances and needs.”  Azalea Court, DAB No. 2352, at 9 (2010) (citing Virginia Highlands Health Rehab. Ctr., DAB No. 2339, at 5 (2010), citing Lake Mary Healthcare, DAB No. 2081, at 17 (2007)), aff’d, Azalea Court v. United States Dep’t of Health & Human Servs., 482 F. App’x 460 (11th Cir. 2012).  Accordingly, the “failure to take measures that are reasonably necessary, under the

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circumstances, to achieve an outcome required by the regulation . . . to ensure that the resident environment remains as free of accident hazards as is possible and that residents receive supervision adequate to prevent accidents” may establish “noncompliance, even though the regulation does not specify the particular measures that the facility must or may take to achieve these outcomes.” Azalea Court at 9 (emphasis in original).

To provide a resident “adequate supervision” consistent with section 483.25(d)(2), a facility has flexibility to choose how to supervise a resident “as appropriate to [its] circumstances and to employ reasonably necessary measures to comply with the regulation”; but, the measures chosen must be able to “reduce known or foreseeable accident risks to the highest practicable degree . . . .”  Heritage Plaza Nursing Ctr., DAB No. 2829, at 6, 20 (2017) (quoting Century Care of Crystal Coast, DAB No. 2076, at 6-7 and Lifehouse of Riverside Healthcare Ctr., DAB No. 2774, at 15 (2017)); see also Windsor Health Care Ctr., DAB No. 1902, at 5 (2003) (supervision or other accident-prevention measures taken must be “adequate” “under all the circumstances”), aff’d Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005); Del Rosa Villa, DAB No. 2458, at 19 (2012) (whether a facility complied with section 483.25(h)(2) depends on whether it took all reasonable and practicable measures to identify, evaluate, and reduce or eliminate the foreseeable risk of an accident), aff’d, Del Rosa Villa v. Sebelius, 546 F. App'x 666 (9th Cir. 2013); Libertywood Nursing Ctr., DAB No. 2433, at 7 (2011) (“ensuring” adequate supervision involves identifying and minimizing safety risks), aff'd, Libertywood Nursing Ctr. v. Sebelius, 512 F. App’x 285 (4th Cir. 2013); Clermont Nursing & Convalescent Ctr., DAB No. 1923, at 21 (2004) (section 483.25(h)(2) requires a facility to eliminate or reduce a known or foreseeable “risk of accident to the greatest degree practicable”), aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App'x 900 (6th Cir. 2005).

A facility’s obligations under section 483.25 also includes [sic] furnishing the care and services set forth in its own resident care policies.  Life Care Ctr. of Bardstown, DAB No. 2479, at 22 (2012) (citing cases), aff’d, 535 F. App'x 468 (6th

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Cir 2013); Life Care Ctr. of Tullahoma, DAB No. 2304, at 34 (2010) (the care and services required by section 483.25 include care and services called for by a facility’s resident care policy), aff’d, Life Care Ctr. Tullahoma v. Sec’y of United States Dept. of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011); Good Shepherd Home for the Aged, Inc., DAB No. 2858, at 12 (2018) (section 483.25 obligates a SNF to follow its own resident care policies).  Indeed, “[o]nce a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents . . . the facility is held to follow through on them.”  Heritage Plaza, DAB No. 2829, at 20.

Logan Healthcare, DAB No. 3036 at 12-14 (footnote omitted and emphasis in original).

Assessment and Care Planning Requirements

The foregoing quotation from Logan Healthcare Leasing indicates that a long-term care facility is required by Medicare participation requirements to assess a resident to determine what care and services are necessary and then develop a comprehensive care plan to guide the delivery of care and services, subject to resident preferences.

The regulations specify the assessment and care planning process that a facility must follow.  The text from the regulations is provided to ensure the reader appreciates that the requirements are detailed and specific.  Regarding assessments, 42 C.F.R. § 483.20 provides:

Resident assessment.  The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident’s functional capacity.

* * * *

(b) Comprehensive assessments—(1) Resident assessment instrument.  A facility must make a comprehensive assessment of a resident’s needs, strengths, goals, life history and preferences, using the resident assessment instrument (RAI) specified by CMS.

* * * *

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(g) Accuracy of assessments.  The assessment must accurately reflect the resident’s status.

42 C.F.R. § 483.20 (italics in original).

Regarding care planning, 42 C.F.R. § 483.21 provides:

(b) Comprehensive care plans.  (1) The facility must develop and implement a comprehensive person-centered care plan for each resident, consistent with the resident rights set forth at [42 C.F.R.] § 483.10(c)(2) and [42 C.F.R.] § 483.10(c)(3), that includes measurable objectives and timeframes to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.  The comprehensive care plan must describe the following:

(i) The services that are to be furnished to attain or maintain the resident’s highest practicable physical, mental, and psychosocial well-being as required under [42 C.F.R.] § 483.24, [42 C.F.R.] § 483.25, or [42 C.F.R.] § 483.40; and

(ii) Any services that would otherwise be required under [42 C.F.R.] § 483.24, [42 C.F.R.] § 483.25, or [42 C.F.R.] § 483.40 but are not provided due to the resident’s exercise of rights under [42 C.F.R.] § 483.10, including the right to refuse treatment under § 483.10(c)(6).

(iii) Any specialized services or specialized rehabilitative services the nursing facility will provide as a result of PASARR [preadmission screening and resident review] recommendations.  If a facility disagrees with the findings of the PASARR, it must indicate its rationale in the resident’s medical record.

(iv) In consultation with the resident and the resident’s representative(s)—

(A) The resident’s goals for admission and desired outcomes.

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(B) The resident’s preference and potential for future discharge.  Facilities must document whether the resident’s desire to return to the community was assessed and any referrals to local contact agencies and/or other appropriate entities, for this purpose.

* * * *

(2) A comprehensive care plan must be—

(i) Developed within 7 days after completion of the comprehensive assessment.

(ii) Prepared by an interdisciplinary team [IDT], that includes but is not limited to—

(A) The attending physician.

(B) A registered nurse with responsibility for the resident.

(C) A nurse aide with responsibility for the resident.

(D) A member of food and nutrition services staff.

(E) To the extent practicable, the participation of the resident and the resident’s representative(s).  An explanation must be included in a resident’s medical record if the participation of the resident and their resident representative is determined not practicable for the development of the resident’s care plan.

(F) Other appropriate staff or professionals in disciplines as determined by the resident’s needs or as requested by the resident.

(iii) Reviewed and revised by the interdisciplinary team after each assessment, including both the comprehensive and quarterly review assessments.

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(3) The services provided or arranged by the facility, as outlined by the comprehensive care plan, must—

(i) Meet professional standards of quality.

(ii) Be provided by qualified persons in accordance with each resident’s written plan of care.

(iii) Be culturally-competent and trauma-informed.

42 C.F.R. § 483.21(b).

As the Board explained in Logan Healthcare Leasing, a long-term care facility must assess a resident and then develop a care plan for the resident.  The delivery of care and services to the resident is based on the care plan and any facility policies that direct the delivery of care and services to residents.  Assessments, care plans, and policies must address identified risks for harm due to accidents that may be avoided and interventions to minimize the risk for harm by provision of adequate assistance devices and/or supervision.  A facility’s failure to provide assistance devices or supervision identified by resident assessment, the resident care plan, or facility policy may be a violation of 42 C.F.R. § 483.25(d).  And if there is a risk for more than minimal harm the violation is noncompliance for which an enforcement remedy may be imposed.

Application of Law to Facts

On September 4, 2020, Petitioner determined based on an assessment of Resident 7, that she:

a.  Required two staff to assist her with bed mobility and transfers.

b.  Required two staff to assist her with personal hygiene including combing her hair, brushing her teeth, and washing and drying her face and hands, but the assessment did not include baths and showers.

CMS Ex. 6 at 40, 47; P. Ex. 6 at 13.  The evidence does not include a care plan for Resident 7 that adopts interventions for giving Resident 7 a bed bath or delivering care while she was in bed, considering her identified fall risk and risk for agitation and physical behaviors.  CMS Ex. 6 at 65; P. Ex. 15 at 2.  Petitioner has not presented evidence to show that there was an assessment of Resident 7 that determined it was safe for a single staff member to provide Resident 7 a bed bath.  Petitioner has presented no evidence that Resident 7’s IDT created a care plan that specifically instructed staff how to safely give Resident 7 a bed bath or provided for a single staff member to do so.

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Petitioner has not presented evidence of a policy describing how to safely give a resident with the assessed needs of Resident 7 a bed bath with only one staff member.  However, the evidence shows that on September 26, 2020, GNA Tawali was giving Resident 7 a bed bath that required that Resident 7 be moved in her bed to accomplish the bath but GNA Tawali had no assistance.

The evidence shows that Resident 7 had a care plan to address the fact she could become aggressive, agitated, and engage in physical behaviors due to her dementia.  CMS Ex. 6 at 11, 64.  There is conflicting evidence about whether Resident 7 became aggressive, agitated, or was resisting during the bed bath on September 26, 2020.  It is not necessary to reconcile the conflicting evidence because the evidence shows that Resident 7 was moving her legs and head during the bed bath which contributed to GNA Tawali being unable to secure Resident 7 before her head moved off the bed.  CMS Ex. 6 at 86, 88, 90; P. Ex. 1; P. Ex. 2; Tr. 216-18, 231-34, 219, 225.

Resident 7 had a fall care plan that required her bed be in the lowest position when she was in the bed with a fall mat in place by the bed.  CMS Ex. 6 at 13, 65; P. Ex. 15 at 2.  However, the evidence shows that during the bed bath Resident 7’s bed was not in the lowest position but was at GNA Tawali’s waist-level.9  Petitioner has not presented evidence that there were fall mats in place by Resident 7’s bed during the bed bath.  CMS Ex. 6 at 86, 88, 90; P. Ex. 1; P. Ex. 2; Tr. 216-18, 231-34, 219, 225.  There is also evidence that Resident 7 was on an air mattress at the time of the fall and air mattresses can be very slippery.  Tr. 314.

The risk for Resident 7 accidentally falling from her bed during a bed bath was foreseeable.  Resident 7 was assessed and care planned for being at risk for falls from her bed.  Resident 7 was assessed as requiring two staff to assist her with moving in bed and for personal hygiene.  Due to her dementia, Resident 7 was assessed and a care plan was developed which recognized that Resident 7 could become agitated, aggressive, and resistive to care.  Resident 7 was assessed and her care plan required that her bed be kept at the lowest level while she was in bed with floor mats in place by her bed.  Keeping Resident 7’s bed at the lowest level with floor mats in place while she was in bed might not prevent Resident 7 from falling from bed.  However, keeping her bed in the lowest position with floor mats shows Resident 7’s IDT recognized the risk for Resident 7 falling from bed and endeavored to minimize the harm to Resident 7 from such a fall.

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There is no dispute that Resident 7 fell from her bed during the bed bath on September 26, 2020.  There is also no dispute that, despite GNA Tawali’s attempt to arrest that fall, Resident 7 suffered injuries including a cut on her forehead, a dislocated humerus, and an intracerebral bleed due to the accident.  CMS Ex. 6 at 86, 88, 90; P. Ex. 1; P. Ex. 2; Tr. 216-18, 231-34, 219, 225.

I conclude that CMS has made a prima facie showing Petitioner violated 42 C.F.R. § 483.25(d) because:

There was a foreseeable risk for an accident, that is, Resident 7 could fall from bed during a bed bath;

Resident 7’s assessed need for two staff to move her in bed was not addressed in a care plan and her care plan to maintain her bed at the lowest-level was not followed; and

Resident 7 suffered actual harm which is more than minimal harm.

I further conclude that Petitioner has not rebutted the CMS prima facie case or established an affirmative defense by a preponderance of the evidence.  Petitioner complains about how Surveyor Crosby performed the survey.  P. Br. at 1-2.  However, inadequate survey performance does not relieve Petitioner of its responsibility to meet all program participation requirements or invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b).  Even if I accepted Petitioner’s complaints about Surveyor Crosby, which I do not, the evidence shows the deficiency and noncompliance by a preponderance of the evidence.

Petitioner argues that the evidence does not show that Resident 7 became combative during her bed bath.  P. Br. at 7-8.  My findings and conclusions are not dependent upon whether Resident 7 was combative during the bed bath.  Petitioner argues that Surveyor Crosby’s finding that there was no evidence that floor mats were in place is purely speculative.  P. Br. at 9-10.  My conclusion that there was noncompliance is not based on the absence of floor mats.10

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Accordingly, I conclude: 

Petitioner violated 42 C.F.R. § 483.25(d);

The violation caused actual harm to Resident 7, which is more than minimal harm; and

There was noncompliance that is a basis for the imposition of an enforcement remedy.

4.  Petitioner violated 42 C.F.R. § 483.25(g)(1) (Tag F692).11

5.  Petitioner’s violation of 42 C.F.R. § 483.25(g)(1) posed a risk for more than minimal harm and amounted to noncompliance.

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

Surveyor Crosby alleged that Petitioner violated the regulation in the case of three residents and that Resident 13 suffered actual harm as a result.  CMS Ex. 1 at 30-31.  The example of Resident 13 is sufficient to establish noncompliance and the examples of the other residents need not be addressed.

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(a)  Findings of Fact

Resident 13, a male, was 56 years old at the time of the survey.  He was admitted to Petitioner on May 28, 2020.  His physician was Gary Sprouse, MD.  CMS Ex. 11 at 35-36, 46, 56, 72.  Resident 13’s diagnoses included a history of stroke, atherosclerotic heart disease, angina pectoris, occlusion and stenosis of his right middle cerebral artery, hypertension, dysphagia (trouble swallowing), Type 2 diabetes, obstructive sleep apnea, gastro-esophageal reflux disease, major depression, psychotic disorder with delusions, and chronic pain disorder, among others.  CMS Ex. 11 at 56, 72.

Resident 13’s IDT adopted a nutrition care plan for him on June 8, 2020, 11 days after admission.  The focus of the care plan was Resident 13’s state of nourishment which was noted to be “less than body requirement characterized by weight [l]oss, inadequate intake, decreased appetite” due to anorexia and decreased appetite.  CMS Ex. 11 at 46, 62.  The outcome or goal of the care plan was to help Resident 13 maintain or increase his weight by December 22, 2020.  Interventions adopted June 8, 2020, included:  Resident 13’s food preferences were to be assessed and he was to be provided his preferences, if Resident 13 refused meals he was to be offered extra nourishment, and he was to be offered liquid supplements such as Ensure®.  There is no evidence that the IDT created new interventions for Resident 13’s nutrition care plan between June 8 and October 21, 2020, roughly four and a half months after his nutrition care plan was first adopted.  New interventions were adopted on October 21, 2020, which included:  Resident 13 was to have laboratory tests; be seen by a cardiologist in preparation for the placement of a gastrostomy tube (G-Tube or feeding tube); and was to be weighed weekly.  CMS Ex. 11 at 46, 62.

An activities of daily living care plan initiated on September 21, 2020, states that Resident 13 had deficits in activities of daily living.  One intervention listed shows he needed staff participation with eating.  The care plan also shows that Resident 13 was totally dependent on staff for bed mobility, transfers, personal hygiene, toilet use, bathing, and dressing.  CMS Ex. 11 at 47, 64.

A third care plan dated October 22, 2020, shows Resident 13 was assessed by his IDT as at risk for potential or actual changes in skin integrity due to fragile skin, poor nutrition, and immobility.  One intervention was to encourage good nutrition and hydration.  CMS Ex. 11 at 48, 62.

A “Weights and Vitals Summary” for Resident 13 dated October 28, 2020, lists weights as follows:

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CMS Ex. 11 at 34, 82.  This evidence of recorded weights shows that between June 1 and October 20, 2020, Resident 13 lost 56.9 pounds dropping from 184.9 pounds to 128 pounds.  Resident 13’s weight loss occurred during the same period as the period during which the IDT failed to update his nutrition care plan, i.e., June 8 through October 20, 2020.  But an MDS with an assessment reference date of June 4, 2020 (the last day of the seven-day MDS assessment period), lists Resident 13’s weight as 180 pounds.  CMS Ex. 8 at 1, 7; CMS Ex. 16 at 14, 19.  Furthermore, an MDS with an assessment reference date of August 18, 2020, lists Resident 13’s weight as 185 pounds.  CMS Ex. 16 at 2, 7.  Therefore, considering the weights recorded in the June 4, 2020 MDS, the August 18, 2020 MDS, Petitioner’s “Weights and Vitals” form, and the absence of other evidence of weights for Resident 13, it is more likely than not that Resident 13 lost 57 pounds during the two months from August 18 through October 20, 2020, which is also within the period when his IDT added no new interventions to Resident 13’s nutrition care plan.

There is evidence that Petitioner’s dietician was monitoring the resident between June and October 2020.

A dietary progress note from June 16, 2020, indicates that Resident 13’s diet was upgraded to mechanical soft by his physician with improved intake observed.  The dietician noted she would continue to monitor.  CMS Ex. 11 at 134.

A quarterly review dietary note dated August 15, 2020, two months later, notes that there were no recent laboratory tests or weights.  A mechanically altered diet and therapeutic diet were in place.  Overall intake was reported to be poor.  The dietician requested that a weight be obtained to monitor weight loss.  CMS Ex. 11 at 134.

The evidence shows that around August 18, 2020, Resident 13’s MDS listed his weight as 185 pounds.  CMS Ex. 16 at 2, 7.  The 185-pound weight on about August 18, 2020, is five pounds more than Resident 13’s weight at admission and very close to his weight recorded on June 1, 2020, reflecting no consistent weight loss during the period between admission on May 28 and August 18, 2020.  But a dietician progress note dated October 6, 2020, just under two months later, included a weight warning based on Resident 13’s

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weight being down to 132.6 pounds, a 52.4 pound weight loss from August 18, 2020 – just over six weeks.  The dietician noted Resident 13’s weight was down, and he often refused meals.  She recommended weekly weighing, Ensure Plus® three times per day, and assessing food preferences.  CMS Ex. 11 at 133-34.  The evidence shows that the dietician was clearly not pursuing a plan to cause Resident 13 to lose weight.

Even though the IDT had not adopted additional nutrition interventions, on October 8, 2020, two days after the dietician issued her first weight warning, the evidence shows that staff were instructed to feed Resident 13 due to his weight loss.  CMS Ex. 11 at 112.  Ensure Plus® was ordered every eight hours beginning October 8, 2020, but that order was discontinued with an order for Ensure Plus® with meals beginning October 14, 2020.  CMS Ex. 11 at 61, 104.  The evidence shows that Resident 13 was also offered snacks in September and October 2020.  CMS Ex. 11 at 33, 44-45, 73, 75, 81.  There is evidence that Resident 13’s eating was being tracked in September and October 2020.  CMS Ex. 11 at 41-43, 57-58, 74-76.

A dietician note dated October 18, 2020, lists a weight warning with Resident 13’s weight reported to be 122 pounds.  The dietician noted there was continued weight loss with the resident on a pureed diet.  She noted Ensure Plus® should be encouraged anytime he failed to consume 50 percent of his meal.  She also recommended consideration of an appetite stimulant.  CMS Ex. 11 at 133.  On October 20, 2020, the dietician recorded that Resident 13 had gained six pounds and his weight was up to 128 pounds.  Resident 13 was reported to continue to refuse meals and his maximum intake was 50 percent.  He was placed on an IV on October 14, 2020, due to abnormal laboratory results.  Ensure Plus® was noted to be provide three times per day to prevent continued weight loss.  The dietician’s note indicates that she was waiting for enteral feeding to begin after tube placement.  CMS Ex. 11 at 133.  As previously noted, there is no evidence that the IDT created new interventions between June 8 and October 21, 2020.  When the IDT acted on October 21, 2020, the new interventions adopted were to get Resident 13 ready for placement of a G-Tube and weekly weighing.  CMS Ex. 11 at 46, 63.  The IDT did not adopt dietary interventions like those the dietician was attempting to unilaterally implement.

The evidence shows Resident 13 developed a pressure ulcer on his sacrum by about October 21, 2020.  CMS Ex. 11 at 29.  He also developed a pressure ulcer on his left elbow around October 23, 2020.  CMS Ex. 11 at 31.  On October 23, 2020, Resident 13 received treatment for a pressure ulcer on his sacrum and left elbow.  CMS Ex. 11 at 28-32, 135.  Surveyor Crosby testified that she considered the pressure ulcers to be actual harm that Resident 13 suffered due to poor nutrition in addition to his 50-pound weight loss.  Tr. 138.

Dr. Sprouse’s progress note for August 3, 2020, indicated Resident 13’s appetite was not great.  But he stated there were no changes in weight or appetite.  He listed no plan for

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addressing the resident’s appetite.  CMS Ex. 11 at 6.  Dr. Sprouse’s progress note for August 6, 2020, indicates Resident 13 was eating with no changes in weight or appetite.  CMS Ex. 11 at 7.  Dr. Sprouse’s progress notes for August 10, 13 and 17, 2020, indicate Resident 13 was eating some, sometimes, or intermittently.  But Dr. Sprouse noted no changes in appetite or weight.  CMS Ex. 11 at 8-10.  Dr. Sprouse’s progress notes for August 20 and 24, 2020, do not mention how the resident was eating only that there was no weight or appetite changes.  CMS Ex. 11 at 11-12.  Dr. Sprouse’s progress notes for September 3, 2020, indicate Resident 13 was eating 50 percent or more of his meals and he had no weight or appetite changes.  CMS Ex. 11 at 15.  Dr. Sprouse’s progress notes for August 27 and 31, 2020, September 7, 10, 14, 17 and 21, 2020, indicate Resident 13 was eating with no change in weight or appetite.  CMS Ex. 11 at 13-14, 16-20.  But Dr. Sprouse’s progress note for September 25, 2020, indicates Resident 13’s appetite was less than ideal and his weight was down since admission.  Inconsistently, the note also indicates there was no change in weight and appetite.  Diagnoses included cachexia (wasting syndrome or anorexia cachexia syndrome).  The plan was to have dietary and speech following the resident.  Dr. Sprouse noted that “no reversible cuase (sic) was found.”  CMS Ex. 11 at 21.  A progress note by Dr. Sprouse dated October 2, 2020, indicates Resident 13 was eating but less than before so his weight was down.  However, the note also indicates Resident 13 had no weight or appetite change.  No plan for diet or weight was included in the note.  CMS Ex. 11 at 25.  A progress note for October 5, 2020, indicates the resident was eating some but with no changes in appetite or weight.  Cachexia was listed as a diagnosis.  In the plan, Dr. Sprouse stated the resident had lost a lot of weight and he intended to discuss that with dietary.  CMS Ex. 11 at 3.  A progress note dated October 8, 2020, indicates Resident 13 was only eating 10 to 25 percent of meals, but stated there was no weight or appetite change.  Diagnosis included cachexia and loss of weight.  The plan was to consider a feeding tube.  CMS Ex. 1 at 22.  Dr. Sprouse’s progress note dated October 12, 2020, indicates Resident 13 was eating but not enough and his weight continued to drop.  However, the note also stated there was no weight or appetite change.  The list of diagnoses included cachexia and the plan listed a discussion with the resident’s sister about a feeding tube, with the sister indicating she would get back to him with a decision.  CMS Ex. 11 at 24.  Dr. Sprouse’s progress note for October 15, 2020, indicated Resident 13 was only eating 25 percent.  He indicated there was coordination with another doctor of placement of a G-Tube.  He indicated that there were no changes in appetite or weight.  Diagnoses listed cachexia.  The plan was to place the G-Tube and that the family agreed to the plan.  CMS Ex. 11 at 4.  Dr. Sprouse’s progress note for October 19, 2020, indicates that Resident 13 was eating poorly and that planning for a G-Tube was in process.  He noted that there were no changes in weight or appetite.  Diagnoses included cachexia and the plan was to place a G-Tube.  CMS Ex. 11 at 2.  A progress note dated September 28, 2020, but signed by Dr. Sprouse on October 21, 2020, indicated Resident 13 had no weight change or change in appetite.  The diagnoses include cachexia.  The plan was to follow-up with dietary and speech.  CMS Ex. 11 at 27.

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I note that not one of Dr. Sprouse’s progress notes lists vital signs such as temperature, blood pressure, pulse, respirations, or weight.  Therefore, how much weight the resident lost from August through October 2020, is not reflected in Dr. Sprouse’s notes.  But Dr. Sprouse’s notes show that he recognized as early as August 3, 2020, that Resident 13’s appetite was not great.  CMS Ex. 11 at 6.  Not until September 25, 2020, did Dr. Sprouse’s notes indicate the Resident’s weight was down and the seriousness of the situation was reflected by the diagnoses of cachexia.  CMS Ex. 11 at 21.  On October 5, 2020, Dr. Sprouse’s notes indicate he was going to discuss the situation with the dietician.  CMS Ex. 11 at 3.  On October 6, 2020, the dietician issued her first weight warning and there is evidence that the dietician swung into action recommending weekly weighing and supplements.  CMS Ex. 11 at 61, 104, 112.  As of October 8, 2020, Dr. Sprouse’s notes show that he was focused on getting a feeding tube placed for Resident 13.  CMS Ex. 11 at 2, 4, 22, 24.

Petitioner presented the testimony of Gary Sprouse, MD at the hearing and his affidavit (P. Ex. 7).  Resident 13 was his patient.  He did not recall being interviewed by Surveyor Crosby.  Tr. 253.  He testified that he was aware of Resident 13’s weight loss, monitored his weight loss, discussed his weight loss with Petitioner’s staff, and implemented interventions to address the weight loss.  Tr. 254.  He testified that Resident 13 had suffered a stroke that affected his appetite and ability to chew and swallow and he needed time to recover.  He decided to monitor Resident 13’s weight while ensuring he received adequate nutrition.  He thought that on admission to Petitioner, Resident 13 would benefit from weight loss, and when he was losing weight, there was no medical concern because he was provided adequate nutrition.  However, he knew that through Resident 13’s stay at Petitioner, he was not eating well and only consuming 25 to 50 percent of his meals.  His plan was to continue monitoring the weight loss while providing adequate nutrition.  In his opinion, Resident 13 was provided adequate nutrition but his weight loss was due to his medical condition.  The fact the resident contracted COVID-19 resulted in him eating even less.  He continued to monitor and believed Resident 13’s weight would improve with dietary changes and after he recovered from the effects of stroke and COVID-19.  However, in late September or early October, he believed that more aggressive interventions were necessary.  He obtained the agreement of the family to proceed with placing a feeding tube.  However, the family moved Resident 13 to a different facility close to their home before a G-Tube could be placed.  He opined that Resident 13’s weight loss was unrelated to Petitioner’s care but rather a direct result of clinical complications.  Specific factors affecting Resident 13’s weight loss included the stroke’s adverse effect on his ability to chew and swallow, COVID-19, and anxiety and fear.  Interventions included changing the consistency of his food, providing supplements, addressing psychological issues, and providing him an aide to assist him with eating.  Dr. Sprouse did not testify to any interventions to specifically address Resident 13’s ability to chew and swallow.  Tr. 254-62.

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On cross-examination he testified that he monitored Resident 13’s weight throughout the resident’s stay at Petitioner.  He testified that Resident 13’s weight was not that important to him because he could tell the resident was losing weight.  He testified that weight is evidence of nutritional status, but it is not the only factor.  He opined it is more important to know how a resident is eating.  He opined that for most residents eating 25 to 50 percent of meals is probably adequate to maintain weight because of the activity level of residents.  Tr. 267-70.  He further explained on cross-examination that the language in his progress notes indicating that Resident 13 had no change in weight or appetite was in error because a template was used to prepare his progress notes and the template included that language and it was not changed by his transcriptionist to be consistent with his other observations of Resident 13.  He testified he observed Resident 13 was losing weight though his appetite did not change.  Tr. 274.  He agreed that Resident 13 lost 50 pounds between June and September 2020.  Tr. 275.  He testified that he did not know when Resident 13 began receiving supplements.  Tr. 280.  He testified that he would not have issued orders for supplements but would have discussed the need with the dietician who would have taken care of ensuring supplemental nutrition was offered to Resident 13.  Tr. 281.

Dr. Sprouse stated in his affidavit that Resident 13’s weight loss was caused by his difficulty chewing and swallowing, which were caused by his stroke prior to admission to Petitioner.  Contributing causes were the effects of the stroke (I infer in addition to the trouble swallowing and chewing), his anxiety and fear caused by the COVID-19 virus in the facility, and the fact he contracted COVID-19.  He opined Resident 13 was provided adequate nutrition with interventions including changing food consistency, providing supplements, addressing his psychological issues, and providing an aide to assist him with eating.  P. Ex. 7 at 3 ¶¶ 16-17.

I find credible Dr. Sprouse’s testimony regarding his medical judgments regarding Resident 13.  However, the contemporaneous records placed in evidence are considered weightier than the recollections of Dr. Sprouse, even though he admitted there are errors in his progress notes.  Many of Dr. Sprouse’s recollections of his management of Resident 13 are general and vague and not nearly as specific as the facts recorded in the documents at or near the time of the events recorded.

(b)  Analysis

“Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.”  42 C.F.R. § 483.25.  Petitioner must ensure that, “[b]ased on the comprehensive assessment of a resident . . . residents [sic] receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.”  Id.  The specific quality of care requirements at issue in this case are 42 C.F.R. § 483.25(g)(1) and (3).  The regulation requires:

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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;

* * * *

(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 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).12  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;

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

A facility is not strictly liable of 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;

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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).

Surveyor Crosby alleged in the SOD that Petitioner violated the regulation because Petitioner failed to identify Resident 13’s significant weight loss and to implement interventions to address the weight loss.  She alleged that Petitioner failed to weigh Resident 13 for three consecutive months, staff failed to provide feeding assistance, the registered dietician’s recommendations were not fully implemented, and the primary care physician was not notified of the weight loss.  CMS Ex. 1 at 30.  Surveyor Crosby opined that the actual harm suffered by Resident 13 was the 50-pound weight loss and the development of two pressure ulcers.  Tr. 138; CMS Ex. 1 at 30-31.  She opined that professional standards of practice are to weigh a resident on admission, readmission, weekly for the first four weeks after admission, and monthly thereafter.  CMS Ex. 5 at 7.  Her opinion regarding the frequency of weighing is consistent with recommendations of CMS in SOM Tag F692.  CMS Br. App. B at 4.

I am not bound by the findings and conclusions of the surveyor but must conduct de novo review with the benefit of additional documentary and testimonial evidence.  I do not, for example, agree with Surveyor Crosby’s finding that Resident 13 was not weighed for three consecutive months or that Dr. Sprouse was not informed of the resident’s weight loss.  But I conclude that the evidence before me supports a prima facie showing by CMS of a violation of the regulation and actual harm for Resident 13.  I conclude that Petitioner has failed to rebut the CMS prima facie showing.

Petitioner recognized shortly after Resident 13’s admission on May 28, 2020, that he was at risk related to his nutrition.  On June 8, 2020, Resident 13’s IDT adopted a nutrition

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care plan because he was at risk for receiving less nourishment than he required due to inadequate intake secondary to his anorexia and decreased appetite.  CMS Ex. 11 at 46, 62.  The IDT’s interventions were to determine and feed Resident 13 what he liked to eat and give him liquid supplements if he refused a meal.

The evidence before me shows that Resident 1 weighed 184.9 pounds on June 1, 2020.  CMS Ex. 11 at 34, 82.  On June 4, 2020, Petitioner reported in Resident 13’s MDS that he weighed 180 pounds.  CMS Ex. 8 at 1, 7; CMS Ex. 16 at 14, 19.  Resident 13’s MDS from August 18, 2020, shows he weighed 185 pounds.  CMS Ex. 16 at 2, 7.  Therefore, using only Resident 13’s weight as a parameter of nutrition, his nutritional status was acceptable within the meaning of 42 C.F.R. § 483.25(g)(1) from his admission to August 18, 2020.

But the evidence shows that between August 18 and October 6, 2020, Resident 13 lost 52.4 pounds, which was 28.32 percent of his body weight.  He lost another 1.2 pounds by October 13, 2020.  Resident 13 lost another 9.4 pounds by October 14, 2020.  But then his weight rebounded six pounds by October 20, 2020.  CMS Ex. 11 at 34, 82; CMS Ex. 15 at 2, 7.  The six-pound increase in weight between October 14 and 20, 2020, is inconsistent with arguments that Resident 13’s weight loss was unavoidable or not related to him accepting and benefiting from more nutrition.  The six-pound weight increase is also evidence that Resident 13’s nutrition improved after October 14, 2020.

Petitioner’s dietician raised a red flag with her note dated October 6, 2020.  The dietician noted Resident 13’s weight was 132.6 pounds, down 52.4 pounds from his 185 pounds recorded in his MDS on August 18, 2020.  The dietician recommended weekly weighing of Resident 13.  She also recommended that he be provided a liquid supplement three times each day and food he preferred.  Other than the weekly weighing, the dietician’s interventions are no different than interventions adopted by Resident 13’s IDT on June 8, 2020, in his nutrition care plan.  CMS Ex. 11 at 46, 62, 134.  I infer that the dietician’s recommendation for weekly weighing means she was using that as evidence of whether Resident 13 was receiving adequate nutrition.  The dietician should have been aware of the June 8, 2020 nutrition care plan and considered that interventions of offering preferred foods, liquid supplements, and the snacks Resident 13 was given in September 2020, were insufficient to provide nutrition Resident 13 needed given his loss of 52.4 pounds (28.32 percent of his body weight) between August 18 and October 6, 2020.

The IDT implemented a care plan on September 21, 2020, that provided staff would assist Resident 13 with eating.  CMS Ex. 11 at 47, 64.  But the IDT did not update his nutrition care plan.  It is possible that as of September 21, 2020, Resident 18 had not lost significant weight, but that is unknown because there is no evidence of his weight at the time.  The dietician’s note from October 8, 2020, reflects that staff were to feed Resident 13.  On October 8, 2020, she also recommended a liquid supplement three times per day but changed that to with meals on October 14, 2020.  CMS Ex. 11 at 61, 104.  Whether

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liquid supplements were to be offered three times per day as recommended on October 6 and 8, 2020, or three times per day with meals, the amount of nutrition offered was unchanged as the dietician recommended the same supplement.

On October 18, 2020, after Resident 13’s weight dropped to 122 pounds, the dietician became more aggressive recommending an appetite stimulant.  She modified her liquid supplement recommendation slightly from three times per day with meals to with meals if the resident failed to consume 50 percent.  CMS Ex. 11 at 133.  I find no evidence that an appetite stimulant was ordered for Resident 13.

Dr. Sprouse’s progress notes from August 3, 2020 to September 25, 2020, show he recognized Resident 13’s appetite was not great but he was eating and mentioned no observed weight loss.  CMS Ex. 11 at 6-20.  For the first time, on September 25, 2020, Dr. Sprouse noted that Resident 13’s weight was down though he did not say how much, and he listed a diagnosis for cachexia.  The intervention he listed in his note was to have dietary and speech follow the resident, which I infer was to get Resident 13 to eat more.  CMS Ex. 11 at 21.  In his note from October 5, 2020, he stated that Resident 13 had lost a lot of weight and intended to discuss that with dietary.  CMS Ex. 11 at 3.  Dr. Sprouse’s notes do not list specific interventions he was considering.

Between about September 25 and October 5, 2020, Dr. Sprouse showed awareness that Resident 13 was losing too much weight.  On October 6, 2020, the dietician also showed she was aware of the weight loss.  However, between the two of them, no interventions were implemented in addition to those originally conceived by the IDT in its care plan of June 8, 2020, i.e., feed him what he liked and give him liquid, except checking his weight weekly and consulting with dietary.  Dr. Sprouse did add the new diagnosis of cachexia.  There is no evidence that Resident 13’s IDT, which should include Dr. Sprouse and the dietician, met to discuss interventions to address Resident 13’s weight loss.  42 C.F.R. § 483.21(b)(2)(ii).  I note that there is also no evidence that the IDT met and reviewed Resident 13’s nutrition care plan after the MDS assessments in June and August 2020, though that is required by 42 C.F.R. § 483.21(b)(2)(iii).

The evidence shows that from August 18, 2020, to about October 6, 2020, Resident 13 experienced a severe weight loss.13  Resident 13’s IDT and Petitioner were aware that

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Resident 13 was at risk for weight loss due to poor nutrition from the residuals of his stroke affecting his chewing and swallowing, his limited appetite, and his food preferences.  There is no evidence that Petitioner recognized Resident 13’s weight loss or made an effort to improve his nutrition from August 18, 2020 until about September 25 or October 5 and 6, 2020.  The evidence is sufficient to make the CMS prima facie showing that Petitioner violated 42 C.F.R. § 483.25(g)(1) because Petitioner failed to ensure Resident 13 maintained acceptable parameters of nutritional status, evidenced by usual or desirable body weight.  Therefore, the burden is upon Petitioner to show by a preponderance of the evidence that there was no regulatory violation or that it did not pose a risk for more than minimal harm to Resident 13.  Petitioner could meet its burden by showing it provided adequate nutrition but Resident 13’s clinical condition or his preferences made it impossible to maintain his weight or an acceptable electrolyte balance.

Petitioner argues that there is no requirement to “document assessments, identifications, and monitoring of resident’s weight.”  P. Br. at 13.  Petitioner argues that so long as it provided sufficient nutrition, assessed the resident’s nutritional status, identified nutritional risks, monitored and modified interventions, and evaluated and managed the causes of nutritional risks, it is in substantial compliance with the regulation.  P. Br. at 13.  Petitioner’s theory that it need not document actions it took to maintain compliance with the regulation and ensure adequate nutrition for each resident is faulty because without documentation how can Petitioner prove by a preponderance of the evidence it was in compliance because it took necessary actions.  This case demonstrates the fallacy.  Contrary to the argument of Petitioner, the evidence in this case does not show that Petitioner did anything to ensure Resident 13’s nutritional status between August 18 and September 25 or October 6, 2020, when he lost over 28 percent of his body weight.  The testimony of Dr. Sprouse and the documents in evidence do not show that the weight loss was observed or that there were interventions to slow or stop the loss or minimize its impact on Resident 13.

Petitioner also argues that Dr. Sprouse confirmed that Resident 13’s weight loss was due to his medical condition.  Petitioner cites Dr. Sprouse’s testimony.  Dr. Sprouse testified:

The resident, in fact, was provided with necessary nutrition throughout his time at the facility, and his weight loss was not due to lack of awareness, it was due to his medical condition.  However, my concerns evolved with time, especially after the resident contracted the COVID-19 virus, which resulted in him eating less.

I continued to observe his weight loss during this time, but again felt that clinically, it would improve if select dietary

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changes were made after recovering from his CVA and COVID infection.

In late September, early October, it was evident that the dietary supplements and his slow ability to recover from the stroke, and subsequent COVID infection, was not adequate.  And at this point, I believe that a more aggressive intervention was necessary.

Tr. 255.  The regulation requires that Petitioner ensure that a resident maintains acceptable parameters of nutritional status.  The regulation also provides defenses for Petitioner’s failure to ensure adequate nutritional status by allowing for a showing that the resident’s clinical condition or the resident’s preferences made it impossible.  42 C.F.R. § 483.25(g)(1).  There is no evidence or assertion by Petitioner that Resident 13’s preferences caused his weight loss.  Rather, the gist of Petitioner’s argument is that Resident 13’s medical condition made it impossible to maintain his weight.  However, Dr. Sprouse’s testimony does not support that position.  He stated that the weight loss was due to his medical condition, he did not state that maintaining his weight was impossible due to Resident 13 clinical or medical condition.  In fact, he went on to testify that he thought Resident 13’s nutrition as evidenced by his weight could improve in the future if select dietary changes were made, although he ultimately decided a feeding tube was necessary.  Dr. Sprouse’s progress note dated October 8, 2020, is the first record that he was considering a feeding tube.  CMS Ex. 11 at 22.

Also inconsistent with Petitioner’s position is the fact that Resident 13’s weight rebounded six pounds by October 20, 2020.  CMS Ex. 11 at 34, 82; CMS Ex. 15 at 2, 7.  The six-pound increase in weight between October 14 and 20, 2020, is inconsistent with an argument that ensuring Resident 13 received adequate nutrition was impossible due to his medical condition.  The six-pound weight increase shows it is more likely than not that Resident 13’s nutritional status improved after October 14, 2020.

I conclude that Petitioner has failed to rebut the CMS prima facie showing that Petitioner violated 42 C.F.R. § 483.25(g)(1) and that the violation caused actual harm and amounted to noncompliance that is a basis for the imposition of an enforcement remedy.

7.  Petitioner violated 42 C.F.R. § 483.20(g) (Tag F641).  

8.  The violation of 42 C.F.R. § 483.20(g) posed a risk for more than minimal harm.

9.  Petitioner has not rebutted the prima facie showing of noncompliance.

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CMS informs me in its post-hearing brief that the CMP imposed is based primarily on the noncompliance under Tags F689 and F692.  But CMS asserts that the other eight citations of noncompliance alleged to pose a risk for more than minimal harm without actual harm or immediate jeopardy (the less severe allegations of noncompliance) are “supported by a preponderance of the evidence and . . . should be upheld.”  CMS Br. at 1 n.2.  CMS did not waive consideration of the less severe allegations of noncompliance but took the position that they were unlikely to affect the enforcement remedy if noncompliance was found under both Tags F689 and F692.  CMS Br. at 1.  Petitioner did not concede any of the less severe alleged allegations of noncompliance.  Accordingly, review of the less severe allegations of noncompliance proceeds, albeit in a more summary fashion.

Surveyor Crosby alleges in the SOD that Petitioner violated 42 C.F.R. § 483.20(g) in the case of Resident 13 because Petitioner failed to ensure accurate assessments of his weight were used in completing MDSs.  The SOD alleges the violation posed a risk for more than minimal harm.14  CMS Ex. 1 at 2.  Surveyor Crosby specifically focused on the MDS with an assessment reference date of August 18, 2020, which indicated Resident 13 had no recent weight gain or loss and listed his weight as 185 pounds.  CMS Ex. 16 at 1, 7.  The surveyor alleges in the SOD that she could find no recorded weight for Resident 13 within the 30 days prior to August 18, 2020.  She further alleges that the instructions for completing the MDS require that the weight listed on the MDS be obtained within the 30 days preceding the assessment reference date.  CMS Ex. 1 at 3; CMS Ex. 5 at 9-10; Tr. 187-90.

Petitioner is required by 42 C.F.R. § 483.20 to “conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident’s functional capacity.”  42 C.F.R. § 483.20.  The assessment is required to “accurately reflect the resident’s status.”  42 C.F.R. § 483.20(g).  The gist of Surveyor Crosby’s allegations is that she could not verify that the 185-pound weight listed in the August 18, 2020 MDS was accurate.15  The SOD reflects that she expressed her concern to Petitioner’s Administrator, but there is no indication that the Administrator responded by providing evidence of weighing of Resident 13 within the 30 days preceding August 18, 2020.

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Surveyor Crosby’s allegations in the SOD and her testimony are sufficient to make the CMS prima facie showing of a violation of 42 C.F.R. § 483.20(g) that posed a risk for more than minimal harm.

Petitioner’s argument is that CMS imposes no specific requirement for documenting weight.  Petitioner also argues that it is reasonable to infer that the 185-pound weight listed in the August 18, 2020 MDS was obtained in August 2020.  P. Br. at 14-15.  Petitioner’s problem is that without evidence that the weight listed in the MDS was recent, it is very difficult or impossible for Petitioner to meet its burden of persuasion.  Petitioner had the opportunity during the survey and again at hearing to present a document or a witness who could explain when Resident 13 was weighed prior to completion of the August 18, 2020 MDS but Petitioner failed to present the document or the witness.  To be clear, I do not find Surveyor Crosby drew the inference that the 185-pound weight was not obtained within 30 days preceding August 18, 2020.  Rather, she wanted evidence that the weight listed in the assessment was accurate as required by 42 C.F.R. § 483.20(g).  The evidence was not presented to her or me.

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.20(g) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

10.  Petitioner violated 42 C.F.R. § 483.21(b)(1) (Tag F656).

11.  The violation of 42 C.F.R. § 483.21(b)(1) posed a risk for more than minimal harm.

12.  Petitioner has not rebutted the prima facie showing of noncompliance.

The regulation requires that Petitioner develop and implement a comprehensive care plan for each resident.  The comprehensive care plan must be developed and implemented with due consideration for resident rights.  The care plan must be developed and implemented to meet the resident’s medical, nursing, mental, and psychosocial needs.  42 C.F.R. § 483.21(b)(1).  The regulation is very specific as to services that must be provided to “attain or maintain the resident’s highest practicable physical, mental, and psychosocial well-being.” 42 C.F.R. § 483.21(b)(1)(i).  As previously mentioned, the care plan must be prepared by the resident’s IDT.  42 C.F.R. § 483.21(b)(2).

In the SOD, Surveyor Crosby alleged examples related to five residents to show the regulatory violation.  The example related to Resident 7 is sufficient to show the violation.  Surveyor Crosby also determined and alleged that the violation posed a risk for more than minimal harm.  CMS Ex. 1 at 4-5.  Surveyor Crosby explained in her

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declaration that Resident 7’s care plan required that fall mats be in place at bed side.  However, in investigating Resident 7’s fall from bed during the bed bath that was the subject of Tag F689 discussed above, no one seemed to know whether the fall mats were in place.  And Surveyor Crosby found no documentary evidence that the fall mats were used prior to the fall.  CMS Ex. 5 at 11.  Her testimony is consistent with the allegations in the SOD.  CMS Ex. 1 at 7-8.

Resident 7 had a fall care plan, initiated February 28, 2013, because she was at high risk for falls due to lack of safety awareness.  The fall care plan, which was revised on March 28, 2013 and September 26, 2017, required that when Resident 7 was in bed, her bed was to be in the lowest position and floor mats were to be at the bedside.  CMS Ex. 6 at 65; P. Ex. 15 at 2.

Petitioner argues that Surveyor Crosby’s allegation regarding the bed mats is based on speculation.  But Surveyor Crosby’s allegation is not based on speculation.  It is undisputed that Resident 7’s care plan required the presence of bed mats when the resident was in bed.  P. Br. at 9.  Surveyor Crosby was looking for either eyewitness or documentary evidence that floor mats were in place by Resident 7’s bed when she fell from her bed on September 26, 2020, but she could find none through examination of Petitioner’s records or interviews of staff.  The allegations in the SOD and Surveyor Crosby’s testimony are sufficient to shift the burden to Petitioner to show by a preponderance of the evidence that it was in substantial compliance.  Petitioner had another opportunity at hearing to present evidence that bed mats were in use at the time of the fall, but Petitioner has failed to do so.

Petitioner asserts in briefing (P. Br. at 10) that GNA Newsome unequivocally stated that “‘they do have fall mats’” referring to Resident 7.  Petitioner cites to Tr. 118 at ln.14-15, which is the cross-examination of Surveyor Crosby.  Surveyor Crosby testified that GNA Tawali told her during an interview that she could not recall whether there were floor mats in place while she was giving Resident 7 a bath and the resident fell.  Tr. 115.  Surveyor Crosby was clear that she interviewed other GNAs and no one told her there were fall mats in place for Resident 7 at the time of the fall.  Tr. 115-16.  She testified regarding her interview of GNA Newsome that GNA Newsome said that there were fall mats in use for Resident 7.  But Surveyor Crosby understood her to mean fall mats were in use at the time of the survey, not when Resident 7 fell.  Tr. 116-18, 172; CMS Ex. 1 at 28.  Petitioner did not call GNA Newsome to testify at hearing.  Thus, Petitioner has failed to present evidence to show that it implemented Resident 7’s comprehensive care plan by having floor mats in place by Resident 7’s bed when she fell from bed on September 26, 2020.

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.21(b)(1) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

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13.  Petitioner violated 42 C.F.R. § 483.25(b)(1) (Tag F686).

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

15.  Petitioner has not rebutted the prima facie showing of noncompliance.

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).  Surveyor Crosby cited examples related to three residents to show the violation of the regulation.  The example of Resident 15 is sufficient to show the regulatory violation.

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Surveyor Crosby alleged in the SOD that Resident 15 was assessed as at risk for pressure ulcers.  His July 20, 2020 MDS showed that he was assessed as at risk for pressure ulcers, he had one unstageable pressure ulcer, and he was on a turning and repositioning program.  Resident 15 was assessed as totally dependent upon two staff members for bed mobility.  Resident 15’s care plan initiated on May 15, 2020 and revised on September 10, 2020, required that he be turned and repositioned.  According to Surveyor Crosby, she reviewed Petitioner’s records, and she could not find documentation from 43 of 81 shifts showing that Resident 15 was turned and repositioned.  CMS Ex. 1 at 23-24; CMS Ex. 5 at 13 ¶ 65.

Petitioner’s argument is that CMS failed to make a prima facie showing of violation of the regulations because CMS relies upon Surveyor Crosby’s findings and conclusions in the SOD.  Petitioner also argues there was minimal or no testimony by Surveyor Crosby in her declaration or at hearing regarding Tags F686, F695, F711, F842, and F880.  P. Br. at 24-25.  Surveyor Crosby specifically states in her declaration that she wrote the SOD’s citations of noncompliance, and she accurately recorded her observations.  CMS Ex. 5 at 2-3.  She testified in her declaration that she reviewed the clinical records for each of the residents involved, reviewed facility policies and documents, conducted interviews with staff, all of which are documented in the SOD.  She also testified that she reviewed CMS exhibits 6 through 14 in preparing her declaration.  CMS Ex. 5 at 4.  Surveyor Crosby is a trained and experienced surveyor.  CMS Ex. 4.  Petitioner did not question Surveyor Crosby on cross-examination regarding her findings in the SOD or statements in her declaration regarding Tags F686, F695, F711, F842, and F880.  Petitioner has not explained how the evidence it has presented rebuts or raises an issue as to Surveyor Crosby’s credibility regarding her review of the documents and interviews underlying her findings and allegations.  Therefore, I have no basis for rejecting Surveyor Crosby’s testimony or her findings as not credible.  I conclude that Surveyor Crosby’s findings recorded in the SOD and her statements in her declaration are sufficient to make the CMS prima facie showing that Petitioner violated the regulation, and the violation posed a risk for more than minimal harm.  Therefore, the burden to show substantial compliance by a preponderance of the evidence was upon Petitioner.  Petitioner failed to present any evidence and failed to meet its burden.

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25(b)(1) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

16.  Petitioner violated 42 C.F.R. § 483.25(i) (Tag F695).

17.  The violation of 42 C.F.R. § 483.25(i) posed a risk for more than minimal harm.

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18.  Petitioner has not rebutted the prima facie showing of noncompliance.

Petitioner is required by the regulations to ensure that a resident who needs respiratory care is provided such care.  Tracheostomy care and tracheal suctioning are among the cares that must both be provided.  All respiratory care must be consistent with professional standards of practice.  The care must be provided according to the resident’s comprehensive care plan and the resident’s goals and preferences.  42 C.F.R. § 483.25(i).

Surveyor Crosby found and concluded in the SOD that Petitioner violated the regulation because Petitioner failed to ensure that comprehensive care plans were developed and implemented for residents with tracheostomies, to have an effective system to schedule needed specialty care appointments in a timely manner, and to have sufficient qualified professional staff to provided tracheostomy care.  She alleged two examples, Resident 1 and 4.  She also found that the violation posed a risk for more than minimal harm.  CMS Ex. 1 at 51-52.  Surveyor Crosby’s findings and conclusions are based on Petitioner’s records she obtained during the survey and interviews of staff and in evidence marked as CMS exhibits 9 and 10.  The documentary evidence is consistent with Surveyor Crosby’s findings and conclusions.

Petitioner’s argument is that CMS failed to make a prima facie showing of violation of the regulations because CMS relies upon Surveyor Crosby’s findings and conclusions in the SOD.  Petitioner also argues there was minimal or no testimony by Surveyor Crosby in her declaration or at hearing regarding Tags F686, F695, F711, F842, and F880.  P. Br. at 24-25.  Surveyor Crosby specifically states in her declaration that she wrote the SOD’s citations of noncompliance, and she accurately recorded her observations.  CMS Ex. 5 at 2-3.  She testified in her declaration that she reviewed the clinical records for each of the residents involved, reviewed facility policies and documents, conducted interviews with staff, all of which are documented in the SOD.  She also testified that she reviewed CMS exhibits 6 through 14 in preparing her declaration.  CMS Ex. 5 at 4.  Surveyor Crosby is a trained and experienced surveyor.  CMS Ex. 4.  Petitioner did not question Surveyor Crosby on cross-examination regarding her findings in the SOD or statements in her declaration regarding Tags F686, F695, F711, F842, and F880.  Petitioner has not explained how the evidence it has presented rebuts or raises an issue as to Surveyor Crosby’s credibility regarding her review of the documents and interviews underlying her findings and allegations.  Therefore, I have no basis for rejecting Surveyor Crosby’s testimony or her findings as not credible.  I conclude that Surveyor Crosby’s findings recorded in the SOD and her statements in her declaration are sufficient to make the CMS prima facie showing that Petitioner violated the regulation, and the violation posed a risk for more than minimal harm.  Therefore, the burden to show substantial compliance by a preponderance of the evidence was upon Petitioner.  Petitioner failed to present any evidence and failed to meet its burden.

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Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25(b)(1) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

19.  CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.30(b) (Tag F711).

20.  CMS made a prima facie showing that Petitioner’s violation of 42 C.F.R. § 483.30(b) posed a risk for more than minimal harm.

21.  Petitioner has rebutted the CMS prima facie showing of noncompliance.

Pursuant to 42 C.F.R. § 483.30(a), Petitioner must ensure that medial care for each resident is supervised by a physician.  Therefore, Petitioner must ensure that physician visits and physician progress notes meet the requirements of 42 C.F.R. § 483.30(b) and (c).

(b) Physician visits. The physician must—

(1) Review the resident’s total program of care, including medications and treatments, at each visit required by paragraph (c) of this section;

(2) Write, sign, and date progress notes at each visit; and

(3) Sign and date all orders with the exception of influenza and pneumococcal vaccines, which may be administered per physician-approved facility policy after an assessment for contraindications.

(c) Frequency of physician visits.

(1) The resident must be seen by a physician at least once every 30 days for the first 90 days after admission, and at least once every 60 days thereafter.

(2) A physician visit is considered timely if it occurs not later than 10 days after the date the visit was required.

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(3) Except as provided in paragraphs (c)(4) and (f) of this section, all required physician visits must be made by the physician personally.

(4) At the option of the physician, required visits in SNFs after the initial visit may alternate between personal visits by the physician and visits by a physician assistant, nurse practitioner, or clinical nurse specialist in accordance with paragraph (e) of this section.

42 C.F.R. § 483.30(b), (c) (emphasis added).

Surveyor Crosby recorded in the SOD that based on her review of resident medical records she found and concluded that Petitioner failed to ensure primary care physicians for two residents wrote and signed progress notes in a timely manner.  CMS Ex. 1 at 69.

She cited Dr. Sprouse’s progress notes for Resident 13.  Review of those notes supports Surveyor Crosby’s findings and conclusions.  My review of Dr. Sprouse’s typed progress notes in evidence shows that notes were signed from two to up to 25 days after Dr. Sprouse saw Resident 13.  CMS Ex. 11 at 2-27.

Dr. Sprouse was also the primary care physician for Resident 1.  His typed progress notes in evidence were electronically signed from 12 to more than 20 days after he saw Resident 1.  CMS Ex. 9 at 73, 81-90.  Therefore, the documents support Surveyor Crosby’s findings and conclusions.

Surveyor Crosby’s observations recorded in the SOD are fully credible and with the documentary evidence are sufficient to satisfy the requirement for CMS to make a prima facie showing of noncompliance under Tag F711.

However, Dr. Sprouse testified that:

The second issue that was raised was timeliness of the notes, when a note was electronically signed sometime after I saw the resident.  Although the electronic note was signed at a later time, when I leave the facility, there’s always a written note left at the facility.

I subsequently have my transcriptionist type a note that is more legible.  It is the typed note which is electronically signed at a later date.  The written note at the facility was subsequently replaced when the typed note is completed.

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Dr. Sprouse’s testimony was not rebutted, and I have no reason to doubt the credibility of this testimony.  I conclude it is sufficient to rebut the CMS prima facie showing of noncompliance under Tag F711 based on the examples of Residents 1 and 13.

I conclude that the preponderance of the evidence shows no violation of 42 C.F.R. § 483.30(b), no risk for more than minimal harm, no noncompliance as alleged under Tag F711 of the SOD, and the alleged noncompliance is no basis for the imposition of an enforcement remedy.

22.  Petitioner violated 42 C.F.R. § 483.35(a) and (c) (Tag F726).

23.  The violation of 42 C.F.R. § 483.35(a) and (c) posed a risk for more than minimal harm.

24.  Petitioner has not rebutted the prima facie showing of noncompliance. 

At the time of the survey in October 2020, Petitioner was required by 42 C.F.R. § 483.35(a)(3) and (4) and (c) as follows:

The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.70(e).

(a) Sufficient staff.

* * * *

(3) The facility must ensure that licensed nurses have the specific competencies and skill sets necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care.

(4) Providing care includes but is not limited to assessing, evaluating, planning and

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implementing resident care plans and responding to resident’s needs.

* * * *

(c) Proficiency of nurse aides. The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care.

42 C.F.R. § 483.35(a)(3)-(4), (c).

Surveyor Crosby states in the SOD that she reviewed medical records, employee files, and other documentation and conducted interviews.  She found that Petitioner failed to document that it assessed whether four nurses and four nursing assistants had the required competency for feeding tube and tracheostomy care before they were permitted to care for residents with those needs.  CMS Ex. 1 at 73-74.  Surveyor Crosby summarized her findings as to each staff member in the SOD.  She requested documentation from Petitioner to show competency assessments.  But the documents were not provided.  CMS Ex. 1 at 74-80.

It seems that the simplest defense for Petitioner is to present documentation showing that the four nurses and four nurse aids were assessed as competent for feeding tube and tracheostomy care prior to caring for patients with those special needs and prior to the survey.  Petitioner argues the allegation of noncompliance is based only upon Petitioner’s failure to document competency assessments because Surveyor Crosby “did not witness any incompetence.”  P. Br. at 18-19.  While it may be correct that Surveyor Crosby did not directly witness incompetence, she recorded in the SOD a couple incidents that caused her to question whether Petitioner was assessing competency and had maintained some evidence it did so.  Surveyor Crosby cited Resident 7’s fall from bed on September 26, 2020, when GNA Tawali was giving her a bed bath.  CMS Ex. 1 at 79-80.  She also cited the example of Resident 1 who had a tracheostomy.  But three nurses who provided care for Resident 1 in October 2020 had no documents in their files showing that they were competent to provide tracheostomy care.  CMS Ex. 1 at 77-78.

Petitioner cites no authority to support a position that Surveyor Crosby had to directly witness incompetence to cite Petitioner for violation of 42 C.F.R. § 483.35(a)(3)-(4), (c).  In fact, it is obvious from the SOD that Surveyor Crosby was not citing Petitioner for the incompetence of staff under Tag F726.  Rather, she cited Petitioner because Petitioner could not show it had verified that its new and temporary staff had the competency to meet the care needs of its residents.

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Petitioner is correct that CMS does not dictate how a facility is to assess competency and skills of staff and or that the assessment must be documented.  P. Br. at 19.  However, the problem for a facility that does not have a standard process for assessing competency and for documenting the assessment is that it cannot prove to the state agency, CMS, or me that assessments occur.  Petitioner cites several Board and ALJ decisions and asserts that they show that noncompliance will be upheld under Tag F726 only when a surveyor witnesses incompetent care.  P. Br. at 19-20.  Petitioner’s interpretation and application of the decisions cited is in error.  It is true that noncompliance could be cited under Tag F726 if incompetence is observed.  But citing those cases to support the position that a surveyor must witness incompetency and cannot cite a facility for failure to assess and document is unsupported by those decisions.  Indeed, it is consistent with the goal of protecting residents to ensure that facilities are assessing their staff to ensure their competence to deliver necessary care and services.  Therefore, it is entirely appropriate and necessary for surveyors to check facility records to ensure competencies are assessed and a document (paper or electronic) provides the proof the facility needs to avoid being cited.  I note, however, that to the extent evidence of incompetence is supportive of the citation of noncompliance under Tag F726, Surveyor Crosby’s reference to Resident 7’s fall from bed while receiving a bed bath in a manner that violated her care plan, is good evidence of possible incompetence.

I have no basis for rejecting Surveyor Crosby’s testimony or her findings as not credible.  I conclude that Surveyor Crosby’s findings recorded in the SOD and her statements in her declaration are sufficient to make the CMS prima facie showing that Petitioner violated the regulation, and the violation posed a risk for more than minimal harm.  Therefore, the burden to show substantial compliance by a preponderance of the evidence was upon Petitioner.  Petitioner failed to present sufficient evidence and failed to meet its burden.

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.35(a)(3) and (4) and (c) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

25.  Petitioner violated 42 C.F.R. § 483.70(i)(1) and (5) (Tag F842).

26.  The violation of 42 C.F.R. § 483.70(i)(1) and (5) posed a risk for more than minimal harm.

27.  Petitioner has not rebutted the prima facie showing of noncompliance.

Surveyor Crosby alleged in the SOD under Tag F842 that Petitioner violated 42 C.F.R. §§ 483.20(f)(5) and 483.70(i)(1) and (5).  However, based on her findings and conclusions, the violation is more correctly characterized as a violation of 42 C.F.R.

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§ 483.70(i)(1) and (5).  At the time of the survey in October 2020, the regulation required:

(i) Medical records. (1) In accordance with accepted professional standards and practices, the facility must maintain medical records on each resident that are—

(i) Complete;

(ii) Accurately documented;

(iii) Readily accessible; and

(iv) Systematically organized.

* * * *

(5) The medical record must contain—

(i) Sufficient information to identify the resident;

(ii) A record of the resident’s assessments;

(iii) The comprehensive plan of care and services provided;

(iv) The results of any preadmission screening and resident review evaluations and determinations conducted by the State;

(v) Physician’s, nurse’s, and other licensed professional’s progress notes; and

(vi) Laboratory, radiology and other diagnostic services reports as required under § 483.50.

42 C.F.R. § 483.70(i)(1), (5).

Surveyor Crosby stated in the SOD that she reviewed medical records and conducted interviews and concluded Petitioner failed to ensure nursing staff documented in resident records accurately.  She specifically focused on the documentation of the use of heel protectors to prevent or help heal pressure ulcers on Resident 7’s heel and the

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documentation of tracheostomy care for Resident 1 that made it difficult to determine what care was provided.  CMS Ex. 1 at 83-86.

Petitioner’s argument is that CMS failed to make a prima facie showing of violation of the regulations because CMS relies upon Surveyor Crosby’s findings and conclusions in the SOD.  Petitioner also argues there was minimal or no testimony by Surveyor Crosby in her declaration or at hearing regarding Tags F686, F695, F711, F842, and F880.  P. Br. at 24-25.  Surveyor Crosby specifically states in her declaration that she wrote the SOD’s citations of noncompliance, and she accurately recorded her observations.  CMS Ex. 5 at 2-3.  She testified in her declaration that she reviewed the clinical records for each of the residents involved, reviewed facility policies and documents, conducted interviews with staff, all of which are documented in the SOD.  She also testified that she reviewed CMS exhibits 6 through 14 in preparing her declaration.  CMS Ex. 5 at 4.  Surveyor Crosby is a trained and experienced surveyor.  CMS Ex. 4.  Petitioner did not question Surveyor Crosby on cross-examination regarding her findings in the SOD or statements in her declaration regarding Tags F686, F695, F711, F842, and F880.  Petitioner has not explained how the evidence it has presented rebuts or raises an issue as to Surveyor Crosby’s credibility regarding her review of the documents and interviews underlying her findings and allegations.  Therefore, I have no basis for rejecting Surveyor Crosby’s testimony or her findings as not credible.  I conclude that Surveyor Crosby’s findings recorded in the SOD and her statements in her declaration are sufficient to make the CMS prima facie showing that Petitioner violated the regulation, and the violation posed a risk for more than minimal harm.  Therefore, the burden to show substantial compliance by a preponderance of the evidence was upon Petitioner.  Petitioner failed to present any evidence and failed to meet its burden.

Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.70(i)(1) and (5) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

28.  Petitioner violated 42 C.F.R. § 483.80(a) (Tag F880).

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

30.  Petitioner has not rebutted the prima facie showing of noncompliance.

Petitioner is required to have an infection control program that meets the requirement of 42 C.F.R. § 483.80.  The pertinent provisions cited as being violated by Petitioner are 42 C.F.R. § 483.80(a)(1), (2), and (4), which required respectively an infection prevention and control program; written standards, policies, and procedures; and a system for recording incidents and corrective action.  The SOD also cites 42 C.F.R. § 483.80(e)

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and (f) which have to do with handling linens and the requirement for an annual review of the infection control program, neither of which are implicated by the facts cited by the surveyor and are not considered further.

Surveyor Crosby found based on her review of records, interviews, and observations that Petitioner violated 42 C.F.R. § 483.80(a) because Petitioner failed to ensure daily COVID-19 screening including taking temperature and pulse oximetry were done; failed to ensure staff wore face masks properly, and failed to ensure staff were screened for COVID-19 symptoms before entering resident areas.  CMS Ex. 1 at 87-88.  Surveyor Crosby cited the example of Resident 1 in the SOD.  CMS Ex. 1 at 88-90.  Medical records from Petitioner for Resident 1 are in evidence as CMS Ex. 9.  Surveyor Crosby found that Resident 1’s temperatures and pulse oximetry were not recorded daily, which is consistent with Resident 1’s medical records in evidence.  Surveyor Crosby recorded in the SOD that she personally observed a GNA enter a resident’s room with a mask on that was not covering her nose and only partially covering her mouth.  CMS Ex. 1 at 89.  Surveyor Crosby also recorded in the SOD that a physician entered the resident area without first being screened for COVID-19.  CMS Ex. 1 at 89-90.

Petitioner’s argument is that CMS failed to make a prima facie showing of violation of the regulations because CMS relies upon Surveyor Crosby’s findings and conclusions in the SOD.  Petitioner also argues there was minimal or no testimony by Surveyor Crosby in her declaration or at hearing regarding Tags F686, F695, F711, F842, and F880.  P. Br. at 24-25.  Surveyor Crosby specifically states in her declaration that she wrote the SOD’s citations of noncompliance, and she accurately recorded her observations.  CMS Ex. 5 at 2-3.  She testified in her declaration that she reviewed the clinical records for each of the residents involved, reviewed facility policies and documents, conducted interviews with staff, all of which are documented in the SOD.  She also testified that she reviewed CMS exhibits 6 through 14 in preparing her declaration.  CMS Ex. 5 at 4.  Surveyor Crosby is a trained and experienced surveyor.  CMS Ex. 4.  Petitioner did not question Surveyor Crosby on cross-examination regarding her findings in the SOD or statements in her declaration regarding Tags F686, F695, F711, F842, and F880.  Petitioner has not explained how the evidence it has presented rebuts or raises an issue as to Surveyor Crosby’s credibility regarding her review of the documents and interviews underlying her findings and allegations.  Therefore, I have no basis for rejecting Surveyor Crosby’s testimony or her findings as not credible.  I conclude that Surveyor Crosby’s findings recorded in the SOD and her statements in her declaration are sufficient to make the CMS prima facie showing that Petitioner violated the regulation, and the violation posed a risk for more than minimal harm.  Therefore, the burden to show substantial compliance by a preponderance of the evidence was upon Petitioner.  Petitioner failed to present any evidence and failed to meet its burden.

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Accordingly, I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.80(a) that posed a risk for more than minimal harm and was noncompliance and Petitioner failed to rebut the prima facie showing.

31.  Petitioner has failed to show it returned to substantial compliance before December 16, 2020.

CMS determined based on a January 14, 2021 state agency revisit survey that Petitioner returned to substantial compliance on December 16, 2020.  CMS Ex. 2 at 2; Jt. Stip. ¶ 6 (the CMP stopped accruing on December 15, 2020).

Petitioner argues in briefing that it returned to substantial compliance no later than the first week of November 2020, prior to the date December 16, 2020 determined by CMS.  Petitioner alleges it returned to substantial compliance with Tags F641 and F692 by October 13, 2020; Tag F686 by November 16, 2020; Tag F656 on October 30, November 7, and December 5, 2020; Tag F69316 on November 9, 2020; Tag F695 on October 28, 2020; Tag F71117 on October 28, 2020; Tag F76018 on November 1, 2020; and Tag F880 on October 20, 2020.  P. Br. at 28-29; P. Reply at 7-8.

Petitioner states in its proposed finding of facts regarding Tag F641 (42 C.F.R. § 483.20(g)) that it conducted a self-audit and immediately took corrective action by weighing all residents and updating its policy to weigh weekly residents with significant weight loss, citing P. Exs. 8 and 14.  Petitioner’s proposed “Findings of Fact and Conclusions of Law” (PFFCL) at 6 ¶¶ 46-47.  Petitioner asserts the following regarding its return to substantial compliance in its PFFCL:

54.  Petitioner was in substantial compliance as to F-641 and F-692 no later than October 13, 2020.  Pet. Ex. 16.

55.  Petitioner was in substantial compliance as to F-686 no later than November 5, 2020.  Pet. Ex. 17.

56.  Petitioner was in substantial compliance as to F-656 no later than November 7, 2020.  Pet. Ex. 15.

57.  Petitioner was in substantial compliance as to F-693 no later than November 9, 2020.  Pet. Ex. 18.

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58.  Petitioner was in substantial compliance as to F-695 no later than October 28, 2020.  Pet. Ex. 19.

59.  Petitioner was in substantial compliance as to F-711 no later than October 28, 2020.  Pet. Ex. 20.

60.  Petitioner was in substantial compliance as to F-760 no later than November 1, 2020.  Pet. Ex. 21.

61.  Petitioner was in substantial compliance as to F-880 no later than October 20, 2020.  Pet. Ex. 23.

PFFCL at 7-8 ¶¶ 54-61.

For the benefit of the readers, the table that appeared previously in this decision is repeated here and includes Petitioner’s alleged dates of substantial compliance.  The table also notes that CMS elected not to pursue Tags F693 and F760 and that I concluded there was no noncompliance under Tag F711.

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CMS Ex. 1; Tr. 59; PFFCL at 7-9 ¶¶ 54-61.

Petitioner has argued that there was no noncompliance under Tags F689, F726, and F842.  But Petitioner has not asserted that if there was noncompliance that the noncompliance was corrected before December 16, 2020.  Therefore, because the occurrence of even a single instance of noncompliance means Petitioner was not in substantial compliance, Petitioner’s assertions it returned to substantial compliance before December 16, 2020, is without merit.

I further conclude Petitioner has not met its burden to show by a preponderance of the evidence that it returned to substantial compliance with all the allegations of noncompliance it did address.

The date Petitioner achieved substantial compliance impacts the duration of the CMP that may be approved.  Pursuant to 42 C.F.R. § 488.440(h):

(h)(1) If an on-site revisit is necessary to confirm substantial compliance and the provider can supply documentation acceptable to CMS or the State agency that substantial compliance was achieved on a date preceding the revisit, penalties imposed on a per day basis only accrue until that date of correction for which there is written credible evidence.

(2) If an on-site revisit is not necessary to confirm substantial compliance, penalties imposed on a per day basis only accrue until the date of correction for which CMS or the State receives and accepts written credible evidence.

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CMS may also require under 42 C.F.R. § 488.454(e) that Petitioner show it corrected noncompliance and that it is able to remain in substantial compliance.

The Board has concluded that the date a facility returned to substantial compliance is subject to de novo review by an ALJ.  Foxwood Springs Living Ctr., DAB No 2294 at 12-13 (2009).  The Board has concluded that an approved plan of correction is evidence of the measures a facility took to return to substantial compliance.  The Board further concluded that a facility cannot be determined to have corrected a deficiency and returned to substantial compliance based on remedial measures short of those stated in the plan of correction.  A facility’s evidence must permit a finding that the remedial measures implemented were or were likely to be effective to prevent recurrence of the deficiency.  A showing of in-service training, while some evidence, is insufficient without evidence of implementation and monitoring of implementation.  N. Las Vegas Care Ctr., DAB No. 2946 at 13-14 (2019).

Neither party placed Petitioner’s plan of correction for the cited noncompliance in evidence.  But the burden to show by a preponderance of the evidence that Petitioner returned to substantial compliance before December 16, 2020, is upon Petitioner.  The evidence shows that Petitioner was working to correct some of the citations of noncompliance.  But without Petitioner’s plan of correction in evidence, Petitioner cannot show it was more likely than not that it had, in fact, corrected the noncompliance prior to December 16, 2020.

Although Petitioner did not place its plan of correction in evidence, there is evidence that Petitioner adopted a plan to address the failure to obtain weekly and monthly weights on October 13, 2020, which was before the survey began on October 18, 2020.  Requirements of the plan included that weekly and monthly weights were to be reviewed during at risk meetings; and weekly audits were to be completed by the dietician or assistant director of nursing for 90 days to ensure weights were obtained.  The plan states that the date for corrective action to be completed was January 29, 2021.  P. Ex. 8 at 2; P. Ex. 14 at 2.  Petitioner presented evidence weights were obtained for some residents in November 2020.  P. Ex. 16 at 3.  But Petitioner did not present evidence that it monitored to ensure weights were obtained for 90 days as the plan required.  Petitioner asserts it corrected the noncompliance under Tags F641 and F692, both of which involved obtaining resident weights, as of October 13, 2020.  P. Br. at 8; PFFCL at 7 ¶ 54.  But its plan to address its failure to obtain weights states the plan will not be completed until January 29, 2021.  Moreover, there is no evidence of monitoring weights after November 2020.  P. Exs. 8, 14, 16.  This example supports a conclusion Petitioner did not return to substantial compliance before December 16, 2020.

32.  A reasonable enforcement remedy in this case is a CMP of $1,300 per day from October 19 through December 15, 2020.

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I have concluded that:

1.  Petitioner violated 42 C.F.R. §§ 483.20(g); 483.21(b)(1); 483.25(b)(1); 483.25(d); 483.25(g)(1); 483.25(i); 483.35(a), (c); 483.70(i)(1), (5); and 483.80(a).

2.  All the violations posed a risk for more than minimal harm to Petitioner’s residents.

3.  The violations of 42 C.F.R. § 483.25(d) and (g) resulted in isolated incidents of actual harm to the Residents 7 and 13.

4.  The period of noncompliance began no later than October 19, 2020, the first day of the survey, through December 15, 2020, the day prior to the date CMS determined Petitioner returned to substantial compliance with participation requirements.

If a facility is not in substantial compliance with program participation 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 or a per-instance CMP for each instance that a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP – $6,808 per day to $22,320 per day – is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).  The lower range of CMPs – $112 per day to $6,695 per day – is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).  Immediate jeopardy is not alleged in this case, and the lower range of CMPs is applicable.

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 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).  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.  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 I may:  (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) only

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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 noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 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, and 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.

Based on my consideration of the regulatory factors, I conclude that the CMP proposed by CMS is reasonable.  I found no noncompliance under Tag F711, and I recognize that CMS withdrew the allegations of noncompliance under Tags F693 and F760.  However, the CMP I approve is adequately supported by noncompliance under Tags F689 and F692 that caused actual harm to Residents 7 and 13.  I consider no history of noncompliance prior to the survey at issue.  Petitioner does not argue that its financial condition affects its ability to pay the proposed CMP that totals $75,400.  Petitioner’s noncompliance was serious as it caused actual harm to Residents 7 and 13.  Petitioner was culpable because it failed to ensure staff followed the care plans established by the IDTs of Residents 7 and 13.  The failure to follow care plans for two residents shows that there was a risk for more than minimal harm to all Petitioner’s residents – a showing not rebutted by Petitioner.  I have considered Petitioner’s arguments and conclude that none warrant reduction of the CMP that I approve.  P. Br. at 25-29; P. Reply at 7-9.

Based on my consideration of the regulatory factors and the evidence, I conclude that a reasonable CMP is $1,300 per day for October 19 through December 15, 2020, a total CMP of $75,400.  The CMP of $1,300 per day is less than 20 percent of the maximum authorized amount of the lower range of authorized CMPs.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2020).

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III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from October 19 through December 15, 2020.  A reasonable enforcement remedy is a per day CMP of $1,300 for October 19 through December 15, 2020, a total CMP of $75,400.