Christian Care Center, DAB CR6086 (2022)

DECISION

Petitioner, Christian Care Center, was not in substantial compliance with program participation requirements from July 26 through October 10, 2017.  Petitioner was not in substantial compliance due to violations of 42 C.F.R. §§ 483.24, 483.25, and 483.60, and the violations posed immediate jeopardy.  Petitioner also violated 42 C.F.R. §§ 483.35(d)(7), 483.10(j)(2), and 483.12(b) and (c)(1), and the violations posed a risk for more than minimal harm.1   There is a basis for the imposition of enforcement

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remedies.  The following enforcement remedies are reasonable:  a civil money penalty (CMP) of $6,394 per day effective July 26 through August 11, 2017; $1,255 per day effective on August 12, 2017 only; and $105 per day effective August 13 through October 10, 2017; and a denial of payments for new admissions (DPNA) effective September 9 through October 10, 2017.

I.  Background

Petitioner is in Mesquite, Texas, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint Stipulations (Jt. Stip.) at 1-2.  The Texas Health and Human Services Commission (state agency) conducted surveys at Petitioner that ended on June 15, August 12, and September 15, 2017, and found that Petitioner was not in substantial compliance with program participation requirements.  Centers for Medicare & Medicaid Services (CMS) Exhibits (CMS Exs.) 1-6.

On January 9, 2018, after informal dispute resolution and administrative review, CMS issued a reopened and revised initial determination.  CMS advised Petitioner that the state agency found that Petitioner returned to substantial compliance effective October 11, 2017.  CMS further advised Petitioner that it was imposing enforcement remedies including a CMP of $6,394 per day effective July 26 through August 11, 2017; $1,255 per day effective on August 12, 2017 only; and $105 per day effective August 13 through October 10, 2017; and a DPNA effective September 9 through October 10, 2017.  CMS Ex. 1 at 1.  The parties agree that only the allegations of noncompliance cited by the surveys that ended on August 12 and September 15, 2017, are at issue before me.  Jt. Stip. at 2-3 CMS Exs. 7, 21.

Petitioner filed requests for a hearing before an administrative law judge (ALJ) on November 3, 2017 and November 28, 2017.  The cases were assigned to me and I ordered that they be consolidated for hearing and decision.

On January 28 through 30, 2019, a hearing was convened by video teleconference, and a transcript (Tr.) of the proceedings was prepared.  CMS Exs. 1 through 19 and 21 through

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37 were admitted.2   Tr. 27-43.  Petitioner exhibits (P. Exs.) 1, 3, 4, 6 through 10, 15, 17 through 20, 22 and 23, 26 through 28, 30 through 32, and 34 through 37 were admitted as evidence.  Tr. 43-46.  CMS called Surveyor Jerri Harris and Surveyor Sandra Ibarra as witnesses at the hearing.  Petitioner called the following witnesses:  David Sims, Petitioner’s Administrator; Karen Kimberly (Kim) Johnson Cook, Registered Nurse (RN), Petitioner’s Clinical Consultant; Kristine Hansen, Licensed Vocational Nurse (LVN), Assistant Director of Nursing (ADON); and Pearl Merritt, RN, MSN, EdD.

On June 15, 2020, the parties filed briefs (CMS Br. and P. Br., respectively).  CMS and Petitioner filed reply briefs on August 19, 2020 (CMS Reply and P. Reply, respectively).

II.  Discussion

A.  Issues

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

Whether the remedy imposed is reasonable.

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

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Act.3   The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

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

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

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

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per instance basis.  In this case, CMS proposed a per day CMP.  The upper range of a CMP, $6,394 per day to $20,965 per day, is reserved for noncompliance that poses immediate jeopardy to a facility’s residents and, in some circumstances, for repeated noncompliance.4   The lower range of CMP’s, $105 per day to $6,289 per day, applies to noncompliance that poses a risk for more than minimal harm to residents but does not pose immediate jeopardy.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2017).

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

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

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (internal citations 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.5   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 authority) to establish aprima facie case of noncompliance with a regulatory requirement.”  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  “Prima facie” means generally

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that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  Black’s Law Dictionary 1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether 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.  In this case, based on the following analysis, I conclude that CMS has made a prima facie showing of noncompliance by a preponderance of the evidence.

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.6   I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Administrative Law & Practice § 5:64 (3d ed. 2013).

The SOD for the survey that ended on August 12, 2017, alleged noncompliance based on Petitioner’s violations of 42 C.F.R. §§ 483.24 and 483.25(k)-(l) (Tag F3097 , scope and

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severity (s/s) J8 ), 483.60 (Tag F360, s/s J), and 483.35(d)(7) (Tag F497, s/s F).  CMS Ex. 7.

The SOD for the survey that ended on September 15, 2017, alleged noncompliance based on Petitioner’s violations of 42 C.F.R. §§ 483.10(j)(2)-(4) (Tag F166, s/s F), 483.12(a)(3)-(4), (c)(1)-(4) (Tag F225, s/s F),

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483.12(b)(1)-(3), and 483.95(c)(1)-(3) (Tag 226, s/s F).  CMS Ex. 21.

CMS alleges that the noncompliance cited by the surveyor under Tags F309 and F360 during the survey that ended on August 12, 2017, posed immediate jeopardy to resident health and safety from July 26 through August 11, 2017, with immediate jeopardy being abated on August 12, 2017.  CMS Ex. 1 at 1; CMS Ex. 7 at 15, 27-28.  The noncompliance cited under Tag F497 during the August 2017 survey, and Tags F166, F225, and F226 during the September 2017 survey, are all alleged to have posed a risk for more than minimal harm without actual harm or immediate jeopardy.  CMS Exs. 7, 21.  CMS determined that Petitioner returned to substantial compliance on October 11, 2017.  CMS Ex. 1 at 1.  Petitioner stated in its plan of correction for the September 15, 2017 survey that it completed its plan of correction on October 11, 2017.  CMS Ex. 21 at 21, 34.

I conclude, based on the following findings of fact and analysis, that:

CMS made a prima facie showing Petitioner violated 42 C.F.R. §§ 483.24-.25, 483.60, 483.35(d)(7), 483.10(j)(2), and 483.12(b) and (c)(1), and all the violations posed a risk for more than minimal harm;

Petitioner has not met its burden to rebut the CMS prima facie showing of noncompliance or established an affirmative defense as to any of the allegations of noncompliance by a preponderance of the evidence;

Petitioner has not shown that the declaration of immediate jeopardy is clearly erroneous for the noncompliance cited under Tags F309 and 360 based on violations of 42 C.F.R. §§ 483.24-.25 and 483.60; and

The proposed enforcement remedies are reasonable.

Conclusions of Law 1, 2, and 3 address the alleged noncompliance cited under Tags F360 and F309 from the August 2017 survey, which involved Resident 1 and allegedly posed immediate jeopardy.  Conclusion of Law 4 addresses Tag F497, also from the August 2017 survey.  Conclusions of Law 5, 6, and 7 address Tags F225, F226, and F166 from the September 2017 survey.

1.  Petitioner violated 42 C.F.R. §§ 483.24 and 483.25 (Tag F309) and the violation posed a risk for more than minimal harm.

2.  Petitioner violated 42 C.F.R. § 483.60 (Tag F360) and the violation posed a risk for more than minimal harm.

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a.  Facts

Resident 1 was admitted to Petitioner on June 5, 2015.  He had been a resident of Petitioner for nearly two years when the events underlying the alleged noncompliance occurred.  He had multiple diagnosis listed in his records.  CMS Ex. 10 at 2, 13, 28-29.  Petitioner does not dispute its records reflect that Resident 1 was allergic to shellfish from the time of his admission.  CMS Exs. 14 at 4; 15 at 2; P. Ex. 15.  Petitioner placed in evidence a care plan for Resident 1, dated September 8, 2015, which states he had an allergy to shellfish, but lists no specific interventions to handle the allergy.  P. Ex. 10.  Resident 1’s meal ticket for dinner on July 26, 2017 noted that he had “multiple allergies,” but no allergies were specifically listed except black pepper.  CMS Ex. 12.  Resident 1’s meal tickets were updated to specifically reflect a shellfish allergy no later than August 3, 2017 (CMS Ex. 11 at 1; P. Ex. 1), which occurred after the July 26, 2017 incident when Resident 1 was hospitalized for an allergic reaction to shrimp he was served.9

On July 27, 2017, Petitioner reported to the state agency that on July 26, 2017, Resident 1 was served shrimp as his main entrée, of which he ate a bite without realizing it was shrimp because it was chopped.  The resident used his call light to notify staff who found that he had swelling of his mouth and tongue, which triggered a call to Resident 1’s physician and his transfer to the hospital.  CMS Ex. 16 at 1-2, 4.  In its report to the state agency, Petitioner indicated that the error may have been related to a software issue, that Petitioner was requiring that meal tickets be manually marked to reflect allergies and staff was being trained to ensure correct items were served to residents.  CMS Ex. 16 at 2, 5.  There is no dispute that shrimp is a type of shellfish.

A July 26, 2017 progress note records that Resident 1 had an allergic reaction to shrimp that was on his dinner meal tray.  The progress note shows that Resident 1 had to be transferred to Dallas Regional Medical Center on a stretcher.  CMS Ex. 10 at 10; P. Ex. 6 at 3, 18.

Hospital records show that Resident 1 was taken to the Dallas Regional Medical Center by emergency services.  He was assessed as suffering a moderate allergic reaction, including tongue and lip swelling sufficient to impede his communication with hospital staff, tingling and itching on his palms and tongue.  Resident 1 was treated with steroids, Pepcid®, and Benadryl®.  He was discharged back to the nursing home on July 28, 2017.  CMS Ex. 10 at 1; CMS Ex. 13 at 1-2, 6-7, 15-16, 40.

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Petitioner offered a collection of unsworn statements from various staff collected after the August 12, 2017 survey.  P. Ex. 8.  CMS did not object to my consideration of the statements.  P. Ex. 8 reflects the staff was consistent that, prior to the July 26, 2017 incident with Resident 1, if specific allergies were not listed on a resident’s meal ticket, it was necessary for staff to check resident records to know what the specific allergies were.  Some of the staff members stated that if multiple allergies were listed on the meal ticket, they would check resident records.  P. Ex. 8 at 8-10.  None of the staff explained when they checked the resident records relative to when they served a meal.  For example, if the term “multiple allergies” appeared on the meal ticket and no specific listing of those allergies was on the ticket, did staff immediately go to the resident records, check the allergies listed and compare what was on the resident’s tray?  That approach would result in delaying meal service, at least for a resident with allergies and possibly for all residents to be served after the allergic resident, and for that reason, it is not credible that staff checked resident records each time before they served a meal tray when specific allergies were not listed.  Petitioner presented the unsworn statement of one staff member who forthrightly stated that she checked the meal ticket, top to bottom, and if an allergy was listed she would then check for an alternative.  She does not state that she checked resident records to determine if the resident had an allergy to something on the meal tray.  P. Ex. 7.  Another staff member described in detail in an unsworn statement her understanding of the process for selecting meals and checking meal (tray) tickets.  She does not specify whether the procedure described in her statement, dated September 7, 2017, was in place on July 26, 2017, when Resident 1 was served shrimp.  She states that allergies are to be listed on each meal ticket.  P. Ex. 9.  However, Resident 1’s allergy to shrimp was clearly not listed on his dinner meal ticket on July 26, 2017.  CMS Ex. 12.  In Resident 1’s case, the problem is more difficult because the mechanical alteration of the shrimp he was served made it unidentifiable as shrimp.  Therefore, how could staff identify the shrimp to know it was necessary to check the resident’s records to determine it was safe to serve the meal?  Resident 1’s meal ticket for dinner on July 26, 2017 did not list shrimp and states only that an entrée substitute was needed.  Even if the meal ticket listed a shellfish allergy on July 27, 2017, how could staff identify the chopped substance on Resident 1’s plate or tray as being shellfish?  Petitioner does not explain how staff serving meals could be expected to identify food, particularly mechanically altered food, and the assertion they did so is simply not credible.  Petitioner does not argue that its dietary and food service staff had any role in ensuring that Resident 1 did not receive shrimp on July 27, 2017, despite the fact that dietary staff was the group in the best position to protect residents with food allergies.

Jerri Harris testified at the hearing that she conducted the incident investigation (survey) at Petitioner from August 9 through 12, 2017, that was triggered by Petitioner’s self-report.  She testified that she was the only surveyor involved.  Tr. 60-61.  She identified the SOD for the survey that ended August 12, 2017.  She testified that she drafted the document.  Tr. 68-69.  She testified that she cited Petitioner under Tag F360 because she found Resident 1 did not receive nutrition appropriate to his dietary needs.  Tr. 97.  She

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testified that she observed that allergies were not listed on meal tickets and that certified nurse assistants (CNAs) were not checking meal tickets before serving meals during the dinner service.  She testified Petitioner’s staff was not checking the list of residents with allergies against their meal ticket and care plan.  Tr. 98-99.  She also cited Petitioner for noncompliance under Tag F309.  She observed that Resident 1’s shellfish allergy was listed in his care plan, but there were no interventions listed.  She concluded that Resident 1 did not receive care and treatment in accordance with his comprehensive assessment.  She concluded that, based on Petitioner’s policy (CMS Ex. 17), allergies were part of care-planning because the policy required the resident’s interdisciplinary to team (IDT) to review the resident’s allergies at least quarterly during care planning.  Tr. 104-06.  She also testified that it was determined that Petitioner’s noncompliance under both Tags F309 and F360 posed immediate jeopardy because there was a likelihood of serious harm or death.  Tr. 106-07.  Surveyor Harris testified that she cited Petitioner for noncompliance under Tag F497 because she determined that two staff members did not have their annual evaluation.  Tr. 109.  She testified that she made no recommendations regarding enforcement remedies to be imposed on Petitioner.  Tr. 109.  She admitted on cross-examination that Petitioner’s August 12, 2017 survey was the first time she declared that there was immediate jeopardy.  Tr. 117.  I find Surveyor Harris’ testimony regarding her observations and the basis for her conclusions reported in the SOD fully credible.

Petitioner called David Sims, Petitioner’s Administrator, as a witness.  Administrator Sims testified that there had been some problems with the facility’s SureQuest dietary software due to system updates and/or software updates.  He testified that the SureQuest dietary software did not interface directly with the facility’s Matrix electronic health record system and it was necessary to enter resident information in both systems.  He testified that there were checks and balances in place to ensure information was entered in both systems, but he did not testify as to what they were.  He testified that after the incident the facility began its quality assurance investigation.  Tr. 330-32.  He testified regarding Petitioner’s quality assurance investigation and actions following the incident with Resident 1.  Tr. 333-37.  He testified in response to my questioning that he did not know how long there was a problem with SureQuest dietary software printing the words “multiple allergies” on resident meal tickets rather than listing the specific allergens.  He testified, however, that the incident involving Resident 1 was the first time he was aware of the problem.  Tr. 337-38.  He agreed that staff relied upon the software to identify allergens, but staff were to review each residents’ allergies before plating meals to ensure there was no allergens being served to a resident.  His understanding of what happened with Resident 1 was that staff may have been confused about what to serve because Resident 1’s meal ticket stated he had multiple allergies and also listed multiple substitutes.  He could not explain why the fact that Resident 1’s meal ticket stating that he had multiple allergies did not cause staff to attempt to determine his exact allergies from other sources.  Tr. 340-42.  On cross-examination, he testified that Petitioner’s staff

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was unable to identify who served Resident 1 the shrimp.  Tr. 347-48.  Administrator Sims testified forthrightly and credibly.

Kristine Hansen, Assistant Director of Nursing (ADON), testified that it was possible to use resident medical records to verify resident allergies.  Tr. 378.  However, she did not explain when that was required.  She testified that she was not aware of a problem with the SureQuest dietary software not listing specific allergies prior to the incident involving Resident 1.  Tr. 378.  ADON Hansen testified that she was a member of Petitioner’s quality assurance (QA) committee and she participated in efforts to correct the issues that caused the incident involving Resident 1 on July 26, 2017.  Tr. 379-80.

Kim Cook, RN, was the facility’s Vice President of Clinical Services during the August and September 2017 surveys.  In her position, she was the highest-level clinical person with responsibility for more than one facility, but, during the surveys, her office was at Petitioner and she was there daily.  Tr. 411-12.  She testified that prior to the incident involving Resident 1, dietary staff and all nursing staff were trained annually as part of their orientation training and on an as-needed basis to check tray tickets (meal tickets).  Dietary and nursing staff were taught to check:  the name on the meal ticket and ensure the meal tray was delivered to the right person; the type of diet to ensure food on tray was consistent with the listed diet type; and allergies.  She testified staff also received in-service training in dietary matters.  Tr. 414-17.  RN Cook testified that, upon admission, resident allergies are entered in their clinical record.  Allergies are listed on the resident’s face sheet.  As a backup, face sheets were placed in a binder, and a dietary slip listing allergies and other dietary information was sent to the dietary department.  A binder with dietary slips was kept in the dietary service office, which was close to the dining room.  Resident face sheets were kept in binders on the halls where residents lived.  Tr. 418-20.  RN Cook did not testify what dietary or nursing staff was to do if a meal ticket was not clear; for example, if specific allergies were not listed, or if the texture of the food made it impossible to determine the type of food being served.  She did not testify that nursing staff included CNAs.  She did not testify when dietary or nursing staff were trained to check a specific resident’s face sheet, care plan or other clinical records.  RN Cook testified about SureQuest, Petitioner’s dietary management software.  The software was used to print meal tickets and produce production lists for the dietary staff.  Petitioner had used SureQuest since 1999.  She testified that the problem with the software printing “multiple allergies” on meal tickets rather than listing specific allergies came to Petitioner’s attention on or about July 26, 2017 with the incident involving Resident 1.  She testified that there were other problems with SureQuest not directly related to Resident 1.  She testified that previously specific allergies had been listed.  Tr. 420-28.  She admitted in response to my questioning that it was not possible for staff to determine that shrimp was in an entrée, either the primary or alternate, based on what was listed on Resident 1’s meal ticket for July 26 or 28, 2017 (CMS Exs. 12, 11 at 3).  Tr. 438-41.  She also testified in response to my questioning that if “multiple allergies” appeared on a meal ticket rather than a specific list of allergies, staff should look at the resident’s

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electronic health records or the face sheet binder at the nurse station.  Tr. 442.  She did not explain how staff knew they should check records and she did not testify they were trained to do so.  RN Cook also testified about corrective actions of the quality assurance committee after the incident involving Resident 1.  She testified that the root cause analysis performed by the quality assurance committee concluded that the SureQuest dietary software was the cause of the incident with Resident 1.  In response to my question, she testified that staff’s failure to check Resident 1’s records for specific allergies was a contributing factor.  She testified that given all the information listed on Resident 1’s meal ticket, staff were not prompted to check the resident’s record for specific allergens because his allergy to black pepper and his lactose intolerance were listed.  Tr. 444-62.

Petitioner called Pearl Merritt, RN, BSN, Ed.D., Regional Dean of the Texas Tech School of Nursing.  Tr. 482-89.  Dr. Merritt testified that it is common for lactose intolerance to be listed in resident records as an allergy.  However, on cross-examination she qualified her response by stating that she always listed lactose as an allergen in her facility, but she did not state that it was standard practice to do so.  Tr. 508, 565.  She testified it would not be unreasonable for a dietary aide serving trays to look at Resident 1’s meal ticket for July 26 or 28, 2017 (CMS Ex. 11 at 3) and conclude that the reference to multiple allergies was to his lactose intolerance and his black pepper allergy.  Tr. 511.  However, in response to my questioning, Dr. Merritt testified that she interviewed no staff about how they interpreted the wording of Resident 1’s meal ticket on July 26 or 28, 2017 (CMS Exs. 11 at 3; 12).  Tr. 570.  Dr. Merritt testified that it is not reasonable for dietary aides to know all residents’ allergies and they are taught to rely on the resident’s meal ticket.  She testified that if there is confusion on the dietary ticket, staff would go to the resident’s clinical record or ask a dietary director to clarify.  Tr. 514.  She opined that the facility’s training of its nursing and dietary staff was proper and on the required topics.  However, she admitted on cross-examination that she reviewed dates of training and topics, but not the substantive materials used for training. Tr. 517, 562.  She opined that there was no quality-of-care deficiency and explained she thought the QC committee effort after the incident involving Resident 1 was impressive.  Tr. 518-28.  She opined that there was no deficient practice with respect to dietary services.  Tr. 528-29.  She also testified that, based on her experience, when a surveyor observes what he or she believes to be an immediate threat, he or she does not leave before the threat is corrected.  Tr. 531.  She opined that the immediate jeopardy determination was clearly erroneous and totally unjustified.  Tr. 543.  Dr. Merritt did not explain the basis for her opinions that the immediate jeopardy determination was clearly erroneous and totally unjustified.  In discussing the facility’s quality assurance activities, she opined that the facility’s quality assurance meeting was very thorough in determining what happened in the incident with Resident 1 and how they could correct the problem.  Tr. 518, 542.  She also opined that it was not a problem that the facility was unable to identify the specific staff member who served Resident 1 the meal with shrimp.  Tr. 532.  Dr. Merritt’s testimony was credible.  However, I find that her opinions are not weighty.  The gist of Dr. Merritt’s opinions are:

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that Petitioner’s dietary software caused the error that resulted in Resident 1 eating some shrimp; Petitioner’s QA committee acted properly to determine the cause of the error and took corrective action; and that the error did not pose immediate jeopardy.  Dr. Merritt failed to consider, in developing her opinions, that Petitioner had no plan or procedure to ensure that Resident 1, nor other resident’s with a shellfish allergy, were not served and did not eat shellfish other than reliance on the meal tickets produced by the dietary software; the meal ticket for Resident 1 at dinner on July 26, 2017, did not reflect what entrée he was being served; while the meal ticket listed black pepper and lactose intolerance as possible allergens, it did not list shellfish; and there is a dearth of evidence that dietary or nursing staff was trained to actually determine what was being served, other than to observe the meal ticket, and to verify that the meal served did not include allergens.  Dr. Merritt’s opinion that there was no immediate jeopardy is also in direct conflict with the undisputed evidence that Resident 1 had signs and symptoms of an allergic reaction almost immediately after ingesting some of the shellfish he was served, and he had to be transported to the hospital for treatment.  Dr. Merritt identifies no evidence that an allergic reaction to ingestion of shellfish by one who is allergic to shellfish does not pose a risk for serious harm or death.

b.  Analysis Related to Tags F309 (42 C.F.R. §§ 483.24 and 483.25)

The SOD alleges that Petitioner violated 42 C.F.R. §§ 483.24 and 483.25 (Tag F309) and that the violation posed immediate jeopardy.  CMS Ex. 7 at 15-16.

Section 483.24 of Title 42 provides:

Quality of life is a fundamental principle that applies to all care and services provided to facility residents.  Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care.

Section 483.25 of Title 42 provides:

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

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I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. §§ 483.24 and 483.25.  There is no dispute that:

Petitioner knew from approximately the date of his admission that Resident 1 was allergic to shellfish, which includes shrimp (CMS Exs 14 at 4; 15 at 2; P. Ex. 15);

Petitioner adopted a care plan for Resident 1 as early as September 8, 2015, that stated he was allergic to shellfish, but the care plan did not list any specific approaches to handling the allergy (P. Ex. 10 at 2);

On July 26, 2017, an unidentified staff member served shrimp to Resident 1.  He ate some of the shellfish, and then suffered an allergic reaction requiring hospitalization.  Resident 1’s allergic reaction caused him to suffer tongue and lip swelling sufficient to impede his communication with hospital staff, tingling and itching on his palms and tongue.  Resident 1 returned to Petitioner on July 28, 2017.  CMS Ex. 10 at 1, 10; CMS Ex. 13 at 1-2, 6-7, 15-16, 40; CMS Ex. 16; P. Ex. 6 at 3, 18; P. Br. at 12-.

The regulations require Petitioner to ensure its residents receive:

Necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care; and

Treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.

42 C.F.R. §§ 483.24-.25.

CMS has made a prima facie showing of a violation of both 42 C.F.R. §§ 483.24 and 483.25.  In 2015, Petitioner assessed that Resident 1 was allergic to shellfish, including shrimp; and had listed the allergy on Resident 1’s care plan.  Nevertheless, on July 26, 2017, Resident 1 was fed shrimp that caused an allergic reaction.  Petitioner was cited for violation of the regulations because Resident 1 was fed shellfish contrary to his comprehensive assessment and care plan which, although not specifically stated, certainly implied Resident 1 should not be fed shellfish due to the inherent risk for an allergic reaction.  Therefore, Petitioner failed to ensure Resident 1 received the necessary care and services to prevent allergic reaction due to ingestion of shellfish and the mental and physical impact of the reaction, which is a violation of 42 C.F.R. § 483.24.  I also have no problem finding that Petitioner’s failure to protect Resident 1 was a failure to deliver treatment and care in accordance with his care plan.  Even though no specific

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interventions were listed addressing the shellfish allergy, it is both common sense and common knowledge that one who is allergic should not be permitted to ingest the allergen, whether intentionally or negligently.  It was therefore implicit in the care plan that Resident 1 should not have been fed shrimp.  The violations posed a risk for more than minimal harm as shown by the fact that Resident 1 was hospitalized with symptoms consistent with an allergic reaction that had to be treated with medications.

Petitioner argues that “CMS cannot identify a single service . . . [Resident 1’s] care plan required, but which was not provided.”  P. Br. at 17.  Petitioner’s argument ignores the fact that Resident 1’s care plan specifically stated that Resident 1 was allergic to shellfish.  P. Ex. 10 at 2.  Although Petitioner failed to list any approaches/interventions to deal with the problem of the shellfish allergy, Petitioner correctly notes it was not cited for a care-planning deficiency.  However, though not specifically stated in the care plan, it is implicit that, because Resident 1 has a shellfish allergy, he should not be fed shrimp.  Petitioner cannot escape responsibility for failure to deliver necessary care and services consistent with professional standards of practice by its own intentional or negligent failure to give staff specific instructions in a care plan.  Petitioner presented no evidence, nor could it, that professional standards of practice permit the feeding of shrimp to one with a known shellfish allergy.

Petitioner also argues that the blame should be placed upon the software company that sold Petitioner the software that failed to print on Resident 1’s July 26, 2017 meal ticket that he was allergic to shellfish.  Petitioner cites a Texas regulation for the proposition that, in Texas, a facility is not liable for the actions of third-parties or contractors over whom the facility has no control.  P. Br. at 14, 13-14, 17-18.  Petitioner provides no authority to support its suggestion that the Texas regulation has any application in this federal proceeding which is governed by the Act and the regulations promulgated by the Secretary, with which Petitioner agreed to comply as a provider participating in Medicare under a provider agreement.  Act § 1866; 42 C.F.R. §§ 424.505, 424.510(d), 424.515-.516.

Petitioner asserts that Resident 1 was served chopped shrimp as part of his dinner meal on July 26, 2017 due to a computer error, not through any neglect of Petitioner’s staff.  P. Br. at 18.  Petitioner had four residents with known shellfish allergies.  P. Ex. 15; CMS Exs. 14; 15.  Petitioner’s census at that the time of the survey was 120.  CMS Ex. 7 at 1.  Therefore, roughly 3.33 percent of Petitioner’s resident population was allergic to shellfish.  Nevertheless, Petitioner elected to offer shrimp for the evening meal on July 26, 2017.  There is no dispute that the shrimp was so finely chopped that it was unidentifiable as shrimp when served to Resident 1.  P. Br. at 12.  The decision to offer shrimp to Petitioner’s residents and the act of chopping it so finely that it was unidentifiable to staff or Resident 1 were clearly not the result of any software problem.  The bottom-line is that dietary and nursing staff failed to check what entrée Resident 1 was being served for dinner on July 26, 2017.  The fact that Resident 1 sent back more

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than one entrée before being served the shrimp entrée is no defense for Petitioner.  Dietary and nursing staff should have known that shrimp was being served and that at least four of Petitioner’s residents could not be served that entrée without posing a risk for harm to those residents.  Petitioner failed to deliver the necessary care and services under Resident 1’s care plan consistent with professional standards of practice because Petitioner’s dietary and nursing staff failed to protect Resident 1 from the risk of an allergic reaction to ingesting shellfish.  Petitioner cannot avoid responsibility by complaining about problems with its dietary software.

Petitioner also attempts to use its QA committee10 and process as a shield against liability.  Petitioner argues that consideration of Petitioner’s QA committee records is prohibited by both state regulations and 42 C.F.R. § 483.75(h).11 Petitioner argues that, if QA committee documents can be used to cite noncompliance, the QA process is jeopardized.  Br. at 16-17.

Petitioner argues that, because its QA Committee was already addressing the problems with its dietary software and the incident involving Resident 1, it was improper to cite the facility for noncompliance under Tag F309 and F360.  P. Br. at 16-17.  Petitioner set forth a list of the QA Committee’s actions related to Resident 1’s incident, including:  investigating the root cause of the incident and discovering that SureQuest listed only “multiple allergies” and “sub needed” on the meal ticket instead of the specific allergy and the meal served; interviewing all relevant staff members; determining whether all nurses, aides, and dietary staff had the necessary training; directing in-service for all

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facility staff regarding allergy verification and meal card procedures; contacting the software company and resolving the computer issue before the survey; auditing all resident charts; interviewing residents and family members to ensure that the allergy information was accurate; and ensuring that the dietary meal cards were consistent.  P. Br. at 13-16.  Petitioner adds that, based on periodic audits throughout the year, the facility already had been in contact with SureQuest representatives regarding various issues with the dietary software.  P. Br. at 14-15 (citing P. Ex. 4 at 15-91).

Petitioner’s argument is without merit.  In comments to the final rule for 42 C.F.R. § 483.75, the drafters specifically addressed Petitioner’s concern about surveyors citing deficiencies for “issues that the QA Committee was in the process of correcting”:

We [CMS] also retain the proposed requirement that ‘‘Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanction.’’  This requirement is not new; however, it now also includes QAPI [Quality Assurance and Performance Improvement] activities.  As is currently the case, surveyors are instructed not to cite as a deficiency for a requirement other than the QAPI requirements a concern that would not have been identified but for a review of QAPI materials for the purpose of determining compliance with the QAPI regulations.  That said, nothing in this section would preclude a surveyor from citing a concern that is identified based on a review of materials or on observations separate and apart from an assessment of QAPI compliance. Excluding such a concern simply and only because it has also been identified by the QAPI program would be irresponsible of CMS.

81 Fed. Reg. 68,688, 68,806 (Oct. 4, 2016) (emphasis added).

Petitioner does not assert that the surveyors requested or even reviewed QA Committee documents.  Petitioner implies that the surveyors cited the deficiency based on information contained in the facility’s QA documents, but Petitioner has not shown that the surveyors identified the deficiency from reviewing QA documents.  P. Br. at 16.  Surveyor Harris denied receiving or considering documents from Petitioner’s QA committee.  Tr. 92, 128.  During cross-examination, Petitioner asked Surveyor Harris numerous questions about QA committee documents and actions.  Tr. 128-30.  I have no reason to doubt, and find fully credible, Surveyor Harris’ testimony that she did not think it appropriate to ask for QA committee records and did not consider such records in citing noncompliance.  I also do not consider the QA committee records placed in evidence by Petitioner (P. Ex. 4) as evidence of noncompliance and only consider P. Ex. 4 as evidence

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of Petitioner’s efforts to correct the noncompliance.  Furthermore, Petitioner admits in its brief, “[t]he surveyors had knowledge of the incident involving Resident #1 prior to entering the facility.”  P. Br. at 19.  Indeed, the record confirms that the facility self-reported the incident to the state agency on July 27, 2017 – well before the survey began.  CMS Ex. 16.  Accordingly, Petitioner has not shown that the surveyor used QA committee documents improperly to cite the noncompliance related to Resident 1.  Petitioner’s concerns about discouraging effective quality assurance programs are unfounded based on the survey in this case.

Even if the surveyor used QA committee documents, that error would not invalidate the August 2017 survey.  The regulations are clear that any inadequacies in survey performance do not relieve a facility from meeting all the requirements of program participation or invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b).  The Board made clear in Avon Nursing Home, DAB No. 2830 (2017), that the surveyor’s and CMS’s view of the evidence are irrelevant to an ALJ’s de novo review, except to the extent that CMS relies upon unreliable evidence as supporting its findings and conclusions of noncompliance.  The Board explained:

An ALJ decides the noncompliance issue de novo – that is, without deference to CMS’s or the state survey agency’s factual findings or legal conclusion and based on her own evaluation of the credibility of the submitted evidence.  N.C. State Veterans Nursing Home, Salisbury, DAB No. 2256, at 24 (2009).  Because the ALJ reviews CMS’s noncompliance determination de novo, an allegation that the state survey agency used improper methods or personnel to make its findings and conclusions is irrelevant, except to the extent that the state agency’s survey practices undermine the credibility of evidence that CMS identifies as supporting the noncompliance determination.

DAB No. 2830 at 12 (2017).  The Board further stated that “the ultimate issue before an ALJ is . . . ‘whether the evidence as it is developed before the ALJ supports’ CMS’s independent ‘finding of noncompliance’ under the relevant participation requirements.”  Avon, DAB No. 2830 at 11 (citing Sunshine Haven Lordsburg, DAB No. 2456 at 21 (2012), aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014)) (emphasis in original).  I do not rely upon Surveyor Harris’ testimony or her findings and conclusions in the SOD.  The SOD provided Petitioner notice of the allegations of noncompliance and it is considered solely for that purpose in deciding this case.

I conclude that CMS has made prima facie showing of a violation of 42 C.F.R. §§ 483.24 and 483.25 that posed a risk for more than minimal harm and Petitioner has failed to

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rebut the prima facie showing.  Accordingly, Petitioner was not in substantial compliance with the requirement of 42 C.F.R. §§ 483.24 and 483.25.

c.  Analysis Related to Tag F360 (42 C.F.R. § 483.60)

The SOD alleges that that Petitioner violated 42 C.F.R. § 483.60 (Tag F360) with respect to Resident 1 and that the violation posed immediate jeopardy.  CMS Ex. 7 at 15-16.

The regulation requires that a facility must provide each resident with a nourishing, palatable, well-balanced diet that meets his or her daily nutritional and special dietary needs, taking into consideration the preferences of each resident.  42 C.F.R. § 483.60

Based on the facts set forth above, I conclude that CMS has made a prima facie showing that Petitioner failed to provide a diet that met Resident 1’s special dietary needs, a violation of 42 C.F.R. § 483.60 that posed a risk for more than minimal harm.  Resident 1 was allergic to shellfish and the allergy was listed in his care plan.  Nevertheless, Petitioner was served shrimp and experienced symptoms of an allergic reaction that required hospitalization.

Petitioner makes the same arguments related to Tag F360 as it did for Tag F309.  P. Br. at 17-18.  Petitioner’s arguments have no more merit in the context of Tag F360 than they did under Tag F309, and Petitioner’s arguments are rejected for the same reasons.

I conclude that CMS has made prima facie showing of a violation of 42 C.F.R. § 483.60 that posed a risk for more than minimal harm.  Petitioner failed to rebut the prima facie showing.  Accordingly, Petitioner was not in substantial compliance with the requirement of 42 C.F.R. § 483.60.

3.  Petitioner has not met its burden to show that the declaration of immediate jeopardy due to the noncompliance under 42 C.F.R. §§ 483.60 (Tag F360) and 483.24-.25 (Tag F309) was clearly erroneous.

The surveyors determined that the noncompliance under Tags F360 and F309 posed immediate jeopardy from July 26 through August 11, 2017, a total of 17 days.  CMS Ex. 1; CMS Ex. 2; CMS Ex. 7 at 3, 16, 23, 27-28; CMS Br. at 2, 4, 7-10, 18.

Petitioner challenges the immediate jeopardy determination, arguing that there is insufficient evidence of the required elements required for a declaration of immediate jeopardy under SOM App. Q, including immediacy, harm, and culpability.  Petitioner states that the citation of immediate jeopardy has serious consequences for a facility.  Therefore, Petitioner urges that surveyors should be required to strictly comply with all policies of CMS, including procedures, protocols, and surveyor interpretive guidelines.  Petitioner also relies upon the testimony of Ms. Cook and Dr. Merritt, both of whom

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opined that there was no immediate jeopardy due to Petitioner’s noncompliance under Tags F309 and F360.  P. Br. at 18-19.

Immediate jeopardy is “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, 489.3 (emphasis added).  In the context of survey, certification, and enforcement related to SNFs and NFs, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility’s residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, does trigger a right to request a hearing and is subject to review.  42 C.F.R. §§ 488.408(g), 498.3(b)(8) and (13).  Furthermore, the level of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would:  (1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14) and (16).

The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy was clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005)), aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs., 174 F. App’x 932 (6th Cir. 2006); Maysville Nursing & Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab Ctr. – Johnston, DAB No. 2031 at 18-19 (2006), aff’d, Liberty Commons Nursing & Rehab. Ctr. – Johnson v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).  Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy.  Rather, the burden is on the facility to show that that determination

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is clearly erroneous.  Cal Turner Extended Care Pavilion, DAB No. 2384 at 14-15; Liberty Commons Nursing & Rehab. Ctr. – Johnston, 241 F. App’x 76 at 3-4.

Many appellate panels of the Board have addressed “immediate jeopardy.”12   In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317, at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031, at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.”  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  Daughters of Miriam Center, DAB No. 2067, at 15 (2007).

The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2),

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discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. at 56,179 (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Ctr. of Greenville, Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  DAB No. 2450 at 15; DAB

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No. 2067 at 15.  Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Ctr. of Greenville,that panel of the Board stated that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  DAB No. 2450 at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Ctr. and other cases does not define the standard.  The “clearly erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black’s Law Dictionary 269 (8th ed. 2004).  The Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring); Concrete Pipe & Products of California, Inc. v. Construction Laborers, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consolidated Edison Co. of New York v. Nat’l Labor Relations Bd., 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. United States Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed, in discussing the clearly erroneous standard, the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires meaningful review.13   Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

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Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  Dumas Nursing & Rehab., L.P., DAB No. 2347 at 19 (2010), (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff’d, Life Care Ctr. of Tullahoma v. Secretary of U.S. Dep’t of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7-8.  There is a difference between “likelihood,” as required by the definition of immediate jeopardy, and a mere potential.  The synonym for “likely” is “probable,” which suggests a greater degree of probability that an event will occur than is suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  “Jeopardy” generally means “danger, hazard, or peril.”  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences.  Woodstock Care Ctr., DAB No. 1726.

What is the meaning of “serious injury, harm, or impairment” as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm?”  On the first question, the Board recognized in Yakima Valley Sch., DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.14   The

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Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy, there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.”  Id. (citing Daughters of Miriam Ctr.,DAB No. 2067 at 9).  In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as “dangerous, grave, grievous, or life-threatening.”  The Board noted that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise, but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  Daughters of Miriam Ctr.,DAB No. 2067 at 9-10.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found under Tags F309 and F360 based on the violations of 42 C.F.R. §§ 483.60 and 483.24-.25, I have no definite and firm conviction that an error has been committed in the determination that immediate jeopardy existed from July 26 through August 11, 2017.  By serving an entrée with shrimp to Resident 1 despite knowing that he was allergic to shellfish, the facility placed the resident at risk of serious harm.  Indeed, the resident was hospitalized because he suffered a “moderate” allergic reaction, including “tongue swelling, tingling, and itching to hands.”15   CMS Ex. 13 at

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15.  Other residents with food allergies were at risk so long as the facility did not have a process for ensuring that those residents did not receive meals containing ingredients to which they are allergic.

Petitioner argues that the surveyor failed to comply with SOM App. Q when she declared immediate jeopardy.  P. Br. at 18-20.  Petitioner’s reliance on SOM App. Q is misplaced before me.  The SOM is a guide for surveyors in conducting surveys.  It is not enforceable as a regulation.  The regulations, not the SOM, are binding on ALJs and the Board.  Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 18-19 (2012).  While Appendix Q may be instructive on the issue of immediate jeopardy, it is not controlling authority.  Foxwood Springs Living Ctr., DAB No. 2294 at 9 (2009).  Petitioner cites no authority for its position that surveyor deviations from the guidance SOM App. Q, even if shown, are a basis to conclude that the declaration of immediate jeopardy is clearly erroneous.  The regulations are clear that the CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy was clearly erroneous.  42 C.F.R. § 498.60(c)(2).  I conclude that Petitioner cannot meet its high burden in this case because the surveyor may not have complied with provisions of the SOM.

Petitioner has not shown that the declaration of immediate jeopardy based on the noncompliance cited under 42 C.F.R. §§ 483.60 (Tag F360) and 483.24-.25 (Tag F309) during the period July 26 through August 11, 2017 was clearly erroneous.

4.  Petitioner violated 42 C.F.R. § 483.35(d)(7) (Tag F497) and the violation posed a risk for more than minimal harm.

The SOD alleges that Petitioner violated 42 C.F.R. § 483.35(d)(7) (Tag F497) because two CNAs did not have annual performance reviews completed.  The surveyor alleged in the SOD that Petitioner’s Human Resources Director stated that a current annual performance review could not be located for one CNA and no current annual performance review was completed for the second CNA.  The surveyor alleged that 120 facility residents were potentially at risk for more than minimal harm due to receiving care from staff who required training in certain areas.  CMS Ex. 7 at 28-29, Tr. 109.

The regulation provides:

(7) Regular in-service education.  The facility must complete a performance review of every nurse aide at least once every

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12 months, and must provide regular in-service education based on the outcome of these reviews.  In-service training must comply with the requirements of §483.95(g).

42 C.F.R. § 483.35(d)(7) (italics in original).

Petitioner does not dispute that it could not produce documents showing that each CNA received an annual review during the 12 months preceding the August 12, 2017 survey when those documents were requested by the surveyor.  Petitioner did not produce in this proceeding documents showing that annual reviews had been conducted for each CNA.  Petitioner argues that documents it has placed in evidence show that each CNA did receive numerous in-service trainings and skills-checks with return demonstrations during the 12 months preceding the survey.  P. Br. at 21; P. Ex. 20 at 1-60.  I accept that Petitioner’s evidence shows that the CNAs received training.  However, Petitioner has not presented evidence that each CNA was subject to an annual performance review, which is necessary to determine in what areas each CNA needed training.

Petitioner also argues that one of the CNAs received a pay raise during 2017 and, under Petitioner’s policy, that would not have occurred if no annual performance review was completed.  P. Br. at 21; P. Ex. 19 at 1.  I accept that Petitioner has shown that one of the CNAs did receive a pay raise and that is evidence an annual performance review was conducted for that CNA.  However, Petitioner has presented no evidence that the other CNA received the required performance review.

Petitioner argues that 42 C.F.R. § 483.35(d)(7) (Tag F497) establishes a “purely administrative ‘paperwork compliance’” requirement.  Petitioner’s attempt to minimize the clear purpose of the annual performance review requirement of 42 C.F.R. § 483.35(d)(7) is unacceptable.  The regulation is clear that a performance review must be completed every 12 months and the purpose of the review is to determine what training is required for each CNA.  Ensuring CNAs receive the 12-month review and necessary training identified by the review is important to ensure quality of care and services for Petitioner’s residents.

The surveyor determined that the regulatory violation posed a risk for more than minimal harm.  CMS Ex. 7 at 28.  Petitioner does not dispute that, if there was a violation, it posed a risk for more than minimal harm.  P. Br. at 21-22.  Rather, Petitioner argues that there was no widespread risk for more than minimal harm because only two CNAs out of 68 CNAs on staff, that is only 2.9 percent, had paperwork that could not be located.  P. Br. at 21-22.  Petitioner’s argument is not a basis for any relief.  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  Neither condition exists in this case.  The CMP imposed in the higher range is clearly based on the two

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immediate jeopardy Tags F309 and F360 rather than this Tag.  There is no evidence that Petitioner had, or sought to have, a NATCEP.  Even if reviewable, in order to prevail on this argument, Petitioner must meet the heavy burden to show that the scope and severity determination that there was a widespread risk for more than minimal harm was clearly erroneous.  42 C.F.R. § 498.60(c)(2).  Petitioner’s resident population at the time of the August 12, 2017 survey was 120.  CMS Ex. 7 at 1.  Even if only one of the two CNAs did not receive the required annual performance review, Petitioner makes no showing of how many residents that one CNA served daily, weekly, monthly, or annually.  Therefore, Petitioner’s has not met its heavy burden to show that the determination that there was a widespread risk for more than minimal harm was clearly erroneous.

I conclude that CMS presented a prima facie case that Petitioner violated 42 C.F.R. § 483.35(d)(7) and the violation posed a risk for more than minimal harm.  Petitioner failed to rebut the prima facie showing of noncompliance.

5.  Petitioner violated 42 C.F.R. § 483.10(j)(2) (Tag F166) and the violation posed a risk for more than minimal harm.

6.  Petitioner violated 42 C.F.R. § 483.12(c)(1) (Tag F225) and the violation posed a risk for more than minimal harm.

7.  Petitioner violated 42 C.F.R. § 483.12(b) (Tag F226) and the violation posed a risk for more than minimal harm.

Petitioner was cited by the survey completed on September 15, 2017, for the following regulatory violations that were alleged to amount to noncompliance under the Tag indicated because each violation posed a risk for more than minimal harm without actual harm or immediate jeopardy:

Tag F166 – violation of 42 C.F.R. § 483.10(j)(2)16 for failure to promptly resolve grievances of Resident 1 (missing ring and $15), Resident 3 (missing $5), and Resident 4 (missing glasses) (CMS Ex. 21 at 1-18);

Tag F225 – violation of 42 C.F.R. § 483.12(c)(1) and (2)17 for failure to thoroughly investigate an allegation of abuse of Resident 2 and failure to report to

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the state agency the allegation of misappropriation of Resident 1’s ring (CMS Ex. 21 at 18-31); and

Tag F226 – violation of 42 C.F.R. § 483.12(b) based on Petitioner’s failure to implement its written policy and procedures prohibiting abuse, neglect, exploitation of residents, and misappropriation of resident property based on the examples of Residents 1 and 2 as alleged under Tag F225 (CMS Ex. 21 at 31-43).

Resident 118 and her missing ring is common to all three alleged violations.  The example of Resident 1 is sufficient to establish the noncompliance under each Tag.  Therefore, it is sufficient to consider only the example of Resident 1 under each of the three Tags.19

a.  Facts

Resident 1 was initially admitted to the facility on August 16, 2011 and readmitted on May 9, 2013.  She was 87 years old at the time of the September 2017 survey.  CMS Ex. 23 at 1.  Her diagnoses included unspecified psychosis, delusional disorders, hallucinations, dementia, and multiple physical maladies.  CMS Ex. 23 at 2.  A progress note dated August 19, 2017, states that Resident 1 has mild confusion.  P. Ex. 23 at 5.  An inventory of Resident 1’s personal property, dated August 27, 2012, I infer was from her first admission, included a diamond ring.  CMS Ex. 24.

A progress note dated August 13, 2017, shows that, at about 2:25 p.m. that day, Resident 1’s visitor (possibly a relative) reported to a CNA that Resident 1’s diamond ring was missing.  The CNA called LVN Jacquetta Baker, who went to the resident’s room.  Resident 1 told LVN Baker that her ring had been missing for about three weeks after she took it off to clean her hands and then could not recall where she placed the ring.  The visitor insisted that she had seen the ring when visiting the preceding week.  The visitor also asserted that the ring was stolen because Resident 1 was not very lucid.  The resident described the ring as a gold band with 16 diamonds.  The visitor described the ring as a white gold band with diamonds and very valuable.  LVN Baker informed Resident 1 and

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the visitor that the unit manager would be notified about the missing ring.  CMS Ex. 23 at 4.  On August 13, 2017, LVN Baker notified ADON Kristine Hansen who in turn notified Administrator Sims of the allegations that Resident 1’s valuable ring was stolen.  P. Ex. 23 at 1-2.  Petitioner placed in evidence an unsworn statement signed by Mary Thomas on October 11, 2017.  Nurse Thomas states that she heard a day or two after August 13, 2017, that Resident 1’s ring was missing.  She states that she then searched the resident’s room and laundry, asked staff about the missing ring and told them to keep looking for the ring.  She also states that, after hearing from the social worker more than a week later, a family member was still calling about the missing ring.  She decided to prepare a record of concern (ROC) that she gave to the ADON for further investigation.  P. Ex. 23, at 3.  The evidence does not show that Resident 1’s visitor was asked to make the complaint in writing or that the facility grievance procedure was explained to Resident 1.  There is also no evidence of Resident 1’s cognitive state at the time of the complaint.

The documentary evidence does not show that anything more was done about the alleged theft of the ring for about 14 days.  Although ADON Hansen testified that during the 14 days staff was continuing to investigate, she did not testify what was being done during that period.  Tr. 374.

A progress note dated August 27, 2017, 14 days after the initial complaint, indicates that on that day a friend of Resident 1 complained to LVN Elaine Ingram at the nurse’s station that Resident 1’s ring was missing.  LVN Ingram told the visitor that Resident 1’s family would have to call the facility.  Resident 1’s sister subsequently called that day and asked what they needed to do about the ring and LVN Ingram told her to call the Administrator on Monday.  CMS Ex. 23 at 6.  A ROC dated August 27, 2017, records the report of Resident 1’s friend that Resident 1’s ring was missing.  The ROC indicates that Resident 1’s room and the laundry were searched, and no ring was found.  Staff was interviewed and denied seeing the resident wearing a ring.  No documents were found showing that Resident 1 was admitted with a ring.  CMS Ex. 26 at 1.

On September 15, 2017, 33 days after the August 13, 2017 report to Petitioner’s staff that Resident 1’s ring was stolen, Administrator Sims reported the allegation to the state agency.  The report was made during the September 2017 survey.  Administrator Sims reported the allegation as exploitation/misappropriation and noted that the resident has a history of hallucinations.  Administrator Sims reported that Petitioner had begun investigating during the week of August 13, 2017, and staff was unable to determine what happened to the ring.  He stated that the investigation was reopened on September 15, 2017, after he discovered unspecified inconsistencies.  CMS Ex. 25 at 1-2.  No subsequent final report of investigation to the state agency is in evidence.

Petitioner had a policy statement revised April 1, 2014, that listed as its subject “Grievances/Complaints Filing.”  CMS Ex. 34.  The policy provides that a “resident, his or her responsible party, a family member, or appointed advocate may file a grievance or

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complaint concerning treatment, medical, care, behavior of other residents, staff members, theft of property, etc. without fear of threat or reprisal. . . .”  CMS Ex. 34.  The policy required that grievances or complaints be in writing and preferably signed by the person making the complaint or grievance.  An investigation of the allegation is to be conducted and the result reported to Petitioner’s Administrator within five working days of receipt of the grievance or complaint.  The Administrator must approve recommended corrective action.  The person who filed the grievance or complaint is supposed to be informed of the findings of the investigation and any corrective action, though a time-limit for that is not specified.  A written summary of the report is to be filed in the administrator’s office.  If the resident is not satisfied with the outcome the resident may file a written complaint with the local ombudsman.  CMS Ex. 34.  There is no evidence that Resident 1 or her visitors were informed that they could file a ROC or other written complaint/grievance about Resident 1’s missing ring.  Although there is some evidence that an investigation was undertaken, the evidence does not show it was done in five working days, or that Resident 1 or her family were informed of the outcome.  In fact, the evidence shows that on August 27, 2017, 14 days after the August 13, 2017 initial complaint, a new complaint was made.  It was not until August 27, 2017 that a staff member prepared a ROC reporting the missing ring. 

Petitioner also had a policy statement revised November 17, 2014, that lists as its subject “Grievances/Complaints – Staff Responsibility.”  CMS Ex. 35.  The policy provides that, if a staff member overhears or receives a complaint by a resident, a resident’s representative, or interested family member concerning the resident’s care, treatment, abuse, neglect, behavior of other residents, the resident’s food, or missing items, the staff member is to encourage the resident or one acting on behalf of the resident to file a written ROC.  The policy requires that staff inform the resident or person acting on the resident’s behalf that the ROC may be filed with Petitioner’s Administrator or the state agency without fear of reprisal or threat.  Staff are then to inform their supervisor of the concern.  CMS Ex. 35.  The evidence does not show that on August 13 or 27, 2017, Resident 1 or her visitor and friend were told that they should complete a written ROC to report the lost ring and that they could file the ROC with Petitioner’s Administrator or the state agency.

Petitioner had a policy revised March 9, 2012 with the subject “reporting abuse, neglect, exploitation, and other incidents.”  CMS Ex. 33 at 1.  The policy provides that Petitioner does not condone resident abuse, neglect, or exploitation (defined by the policy as a caretaker illegally or improperly using resources of an elderly or disabled person).  The policy provides that Petitioner or staff are to report to the state agency within 24 hours of learning of an allegation of abuse, neglect, exploitation, death under unusual circumstances, a missing resident, misappropriation of resident property, drug diversion, serious or suspicious injury of unknown source, serious accidental injury, fires, or

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conditions that pose a threat to resident health and safety.  CMS Ex. 33 at 1-4.20   The policy provides that an allegation involving exploitation, neglect, or abuse, injuries of unknown source, and misappropriation of resident property must be reported by staff to the administrator immediately.  The administrator investigates and reports to various entities and the state agency.  The policy provides that Petitioner must notify the state agency within 24 hours and a written report of investigation must be filed within five days.  CMS Ex. 33 at 5-6.  The policy provides that if there is a reasonable suspicion that a crime has been committed against a resident then not only the state agency, but one law enforcement entity must be notified not more than 24 hours after the suspicion forms, unless there is an injury in which case a maximum of 2 hours is permitted for reporting.  CMS Ex. 33 at 6.  Petitioner’s evidence shows that on August 13, 2017, Administrator Sims was informed of the allegation that Resident 1’s ring was stolen and that the ring was believed to be “worth some money.”  P. Ex. 23.  No report was filed with the state agency until September 15, 2017.  CMS Ex. 25.  Although the evidence shows that Resident 1’s family threatened to call the police, there is no evidence that Administrator Sims notified any law enforcement agency as required by Petitioner’s policy.

At the hearing, Administrator Sims testified that he first received a text message from ADON Hansen that Resident 1’s family friend raised a concern about Resident 1’s missing ring.  He testified that it was his understanding that Resident 1 told staff that she had taken off her ring and she did not know where she put it.  He testified that Resident 1 did not allege that Petitioner’s staff took her ring.  He testified that staff searched Resident 1’s room and the laundry but were unable to find the ring.  He testified that the social worker told Resident 1’s family that Petitioner’s staff was looking for the ring but had not found it.  He testified that he did not report to the state agency the allegation as misappropriation of property because of Resident 1’s statement that she lost the ring herself and not that someone had taken the ring.  His understanding of the state agency provider letter (CMS Ex. 37) was that it was not necessary to report unless a deliberate theft was alleged.  Tr. 304-09.  He testified that a report was made to the state agency on September 15, 2017 (CMS Ex. 25) because Resident 1 reported to the surveyor that the ring was taken off her finger.  Tr. 309-10, 353.  I find Administrator Sim’s assertion that he was not aware that there was an allegation of misappropriation is not credible.  There is no dispute that on August 13, 2017, Administrator Sims received a text message from

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ADON Hansen that Resident 1’s niece alleged to staff that someone stole Resident 1’s ring and was threatening to call the police.  P. Ex. 23 at 2.  Therefore, Administrator Sims was clearly on notice of an allegation that Resident 1’s property was misappropriated. 21 I also find not credible his testimony indicating that the incident related to Resident 1’s ring was not reportable until Resident 1 specifically alleged on or about September 15, 2017, that the ring was taken off her finger.  On August 13, 2017, Resident 1’s visitor alleged that the ring had been stolen and she informed staff that she was going to contact the police.  CMS Ex. 23 at 4.  It is not credible for Administrator Sim’s and Petitioner’s staff to simply choose to ignore an allegation that resident property was stolen simply because the resident did not make the allegation.  Resident 1 was cognitively impaired, and Administrator Sims does not explain why he would choose to credit the allegations of Resident 1 over the allegations of the visitor who reported the missing ring.

ADON Hansen identified the text she sent to Administrator Sims about Resident 1’s ring.  Tr. 371; P. Ex. 23 at 2.  She testified that she wanted Administrator Sims to know that Resident 1’s family member was alleging that someone stole Resident 1’s ring.  Tr. 371.  She testified in response to my questioning that she believed it was only necessary to report missing resident property when the resident alleges that someone took the property

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and, if that happened, a report needed to be filed with the state agency within 24 hours.  Tr. 386-87.  I find her testimony credible.

Kim Cook testified that she believed that the incident involving Resident 1’s missing ring was not reportable to the state agency on August 13, 2017, because there was no misappropriation of funds and no intentional displacement or removal of Resident 1’s property.  Tr. 468-69.  Ms. Cook further opined that the allegation became reportable once Resident 1 told the surveyor that she believed the ring had been removed from her hand and the incident was reported by the administrator at that time.  Tr. 468-69.  Based on Ms. Cook’s responses to other questions, I infer that she knew that an incident involving an allegation of misappropriation of funds or property was reportable.  It is not so clear that she understood that misappropriation could occur in the case of a theft or taking of resident property under both the state or federal definition of misappropriation, and whether the resident was aware of the theft or not.  I do not find Ms. Cooks’ testimony that the incident related to Resident 1’s ring was not reportable until Resident 1 specifically alleged on or about September 15, 2017, that the ring was taken off her finger.  On August 13, 2017, Resident 1’s visitor alleged that the ring had been stolen and she informed staff that she was going to contact the police.  CMS Ex. 23 at 4.  It is not credible for Ms. Cook and Petitioner’s staff to simply choose to ignore an allegation that resident property was stolen simply because the resident did not make the allegation.  Resident 1 was cognitively impaired, and Ms. Cook does not explain why she would choose to credit the allegations of Resident 1 over the allegations of the visitor who reported the missing ring.

Dr. Merritt opined that the incident involving Resident 1 was not reportable on August 13, 2017, because “it was resolved.”  Tr. 546.  Dr. Merritt indicated that she found significant Resident 1’s statements that she did not know what happened to the ring, that she may have put the ring down, and that she later said not to worry about it and did not show concern herself.  Tr. 545-46.  Dr. Merritt testified that, in her review of the documentation, she did not see any evidence of a deliberate misplacement.  As in the case of Ms. Cook, Dr. Merritt did not testify as to her understanding of what constitutes a misappropriation of property.  Tr. 547.  Dr. Merritt testified that the facility made a reasonable effort to resolve the issues surrounding Resident 1.  Tr. 550.  Dr. Merritt’s opinion is not weighty.  Her testimony indicates that she did not consider the fact that Resident 1 was cognitively impaired.  She also ignored the undisputed fact that Resident 1’s visitor alleged that the ring had been stolen and she was going to call the police.  Dr. Merritt testified that she was not aware of any regulation that required that a grievance or complaint be filed in writing.  Tr. 548.  Dr. Merritt did not testify that she knew that Petitioner’s grievance policies (CMS Exs. 34, 35) required that grievances be in writing.

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c.  Analysis

I conclude based on the foregoing facts, that the preponderance of the evidence establishes a prima facie case of three regulatory violations that pose a risk for more than minimal harm and, therefore, constitute noncompliance with program participation requirements.  The specific regulations violated are:

42 C.F.R. § 483.10(j)(2) (Tag F166) for failure to promptly resolve the grievance related to Resident 1’s missing ring;

42 C.F.R. § 483.12(c)(1) (Tag F225) for failure to thoroughly investigate an allegation of misappropriation of Resident 1’s ring; and

42 C.F.R. § 483.12(b) (Tag F226) Petitioner’s failure to implement its written policy and procedures prohibiting abuse, neglect, exploitation of residents, and misappropriation of resident property.

(i)  42 C.F.R. § 483.10(j)(2) (Tag F166)

Pursuant to 42 C.F.R. § 483.10(j)(2), a resident “has the right to and the facility must make prompt efforts . . . to resolve grievances the resident may have.”

There is no dispute that Petitioner’s records Resident 1 was admitted to Petitioner with a diamond ring.  CMS Ex. 24.  On August 13, 2017, Resident 1’s visitor reported to a CNA that Resident 1’s diamond ring was missing. CMS Ex. 23 at 4.  Administrator Sims received notice of the allegation on the same day.  P. Ex. 23 at 12.  The evidence shows that a week later a family member was still calling about the missing ring.  P. Ex. 23 at 3.  On August 27, 2017, two weeks after the initial complaint, a new complaint about the missing ring was made.  CMS Ex. 23 at 6.  The evidence does not show whether the ring was ever recovered, that the situation was resolved, or that Resident 1 and her family were given notice of the results of Petitioner’s investigation or any corrective action.

The regulation does not define the term “prompt.”  However, Petitioner has two grievance policies that are applicable.  Under Petitioner’s policies a grievance is to be investigated and results reported to the Administrator within five working days.  The policy does not state how quickly the resident or grievant should be informed of the findings of the investigation and any related corrective action.  The evidence, including the testimony of Administrator Sims and the progress notes, show that Petitioner’s staff did not recognize or accept the complaint of Resident 1’s visitor as a grievance.  Petitioner’s staff certainly did not follow its grievance procedure which requires that a grievance be reduced to writing and that the resident and grievant be informed of the grievance procedure.  CMS Exs. 34-35.

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I conclude that CMS made a prima facie showing of a violation of 42 C.F.R. § 483.10(j)(2).  The surveyor determined that the violation posed a risk for more than minimal harm.  Therefore, there is noncompliance that is a basis for the imposition of an enforcement remedy.

Petitioner argues that the allegation in this case is not that it failed to follow its grievance policy, but that it failed to promptly follow it, which it argues is not a basis for a violation.  P. Br. at 2.  Petitioner is incorrect.  The regulation does not define prompt.  Petitioner’s policy does.  Petitioner informs its residents by its policy that the Administrator is going to act in five working days, which I accept as prompt.  In this case, it is not clear that the grievance involving Resident 1’s ring was ever resolved and clearly it was not resolved by September 15, 2017, after a full month, when Administrator Sims reported the misappropriation to the state agency.

Petitioner also argues that, under the SOM, whether a facility engaged in prompt efforts examines whether the grievance was acknowledged and whether the facility worked actively towards resolution.  Petitioner argues it both acknowledged the complaint about Resident 1’s ring and engaged in prompt efforts.  P. Br. at 2.  To the contrary, the preponderance of the evidence shows that Petitioner did not treat the complaint by Resident 1’s visitor on August 13, 2017 as a grievance at all, based on the fact that Petitioner’s staff did not have the grievance reduced to writing as required by Petitioner’s grievance policy.  Petitioner presents no evidence that, at any time within five working days of August 13, 2017, it acknowledged to Resident 1 or her family that it had received the grievance and an investigation was underway as required by Petitioner’s grievance policies.  Petitioner also presents no evidence that the results of an investigation and corrective action were reported to Resident 1 or her family.  There is little doubt that Petitioner did have staff search for the ring, particularly after the second complaint by family on August 27, 2017.  However, the evidence supports a finding in this case that, until about September 15, 2017, Petitioner’s Administrator and other staff were operating under the misconception that the ring did not exist because they missed the inventory document showing that at one time there had been a ring in Resident 1’s possession at the facility.  The evidence shows that Resident 1 had a grievance, though it was articulated by a visitor and relative.  Petitioner did not take the grievance seriously until about September 15, 2017, during the survey, when the missing ring was reported to the state agency as a misappropriation.

I conclude that Petitioner has failed to rebut the CMS prima facie showing of the regulatory violation by a preponderance of the evidence.  Petitioner also failed to rebut the surveyor’s determination that the violation posed a risk for more than minimal harm.

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(ii)  42 C.F.R. § 483.12(c)(1) (Tag F225)

Pursuant to 42 C.F.R. § 483.12(c)(1), when an allegation of abuse, neglect, exploitation, mistreatment, or misappropriation is made, Petitioner has 2 to 24 hours to report the allegation to the state agency and other required authorities depending upon the nature of the complaint and whether any serious injury is involved.  I note the regulation does not state or suggest that Petitioner’s duty to act is dependent upon who makes the allegation of abuse, neglect, exploitation, mistreatment, or misappropriation.

As discussed hereafter under Tag F226, Petitioner had the policy required by 42 C.F.R. § 483.12(b), but Petitioner’s staff failed to implement that policy for more than 30 days after an allegation of theft or misappropriation of Resident 1’s ring was made.

Under this Tag – F225 – it is alleged, regarding Resident 1’s missing ring, that Petitioner failed to report the allegation of misappropriation of the ring within 24 hours of the complaint being received by Petitioner’s staff.  The evidence shows that the complaint was made on August 13, 2017.  Administrator Sims was informed of the complaint that day.  However, the allegation was not reported to the state agency for more than 30 days.

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.12(c)(1).  The surveyor alleged that the violation posed a risk for more than minimal harm.  Therefore, there is noncompliance, which is a basis for the imposition of an enforcement remedy.

Petitioner argues that, under the state agency’s Provider Letter 17-18 (CMS Ex. 37), an incident need not be reported unless facility staff has cause to believe that a reportable event occurred.  P. Br. at 8.  Petitioner is in error.  Provider Letter 17-18 para. 6, the paragraph that specifically addresses misappropriation, provides that a nursing facility must report “any alleged misappropriation” of funds or resident property.  CMS Ex. 37 at 5.  The Provider Letter does not limit reporting to situations when facility staff has cause to believe a misappropriation occurred.  The introductory paragraphs of the Provider Letter state that “an owner or employee of a [nursing facility] who has cause to believe that the physical or mental health or welfare of a resident has been or may be adversely affected by abuse, neglect, or exploitation caused by another person” must report to the state agency the abuse, neglect, or exploitation.  Misappropriation of resident property is not included in this provision of the Provider Letter.  CMS Ex. 37 at 1.  Even if the Provider Letter is read so that the “cause to believe” language also applies to misappropriation, the “cause to believe” language is not limited to situations where there is reasonable cause, probable cause, good cause, or a similar standard.  Rather “cause to believe” must be read to include any cause to believe, such as a mere allegation that a misappropriation has occurred.  Similarly, the federal regulation does not limit the reporting requirement to situations where there is reasonable cause, good cause, probable cause, or the like.  Rather, 42 C.F.R. § 483.12(c) requires reporting “in response to

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allegations.”  Indeed, 42 C.F.R. § 483.12(c)(1) states that “all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property” must be reported immediately.

(iii)  42 C.F.R. § 483.12(b) (Tag F226)

Pursuant to 42 C.F.R. § 483.12(b), Petitioner “must develop and implement written policies and procedures” that, among other things, prohibit and prevent, abuse, neglect, exploitation of residents, and misappropriation of resident property, provide for investigation of any allegations, provide for staff training, provide for quality assurance, and ensure reporting of crimes.

Petitioner had a policy, revised March 9, 2012, with the subject “reporting abuse, neglect, exploitation, and other incidents.”  CMS Ex. 33 at 1.  The policy provides that Petitioner does not condone resident abuse, neglect, or exploitation (defined by the policy as a caretaker illegally or improperly using resources of an elderly or disabled person).  The policy provides that Petitioner or staff are to report to the state agency within 24 hours of learning of an allegation of abuse, neglect, exploitation, death under unusual circumstances, a missing resident, misappropriation of resident property, drug diversion, serious or suspicious injury of unknown source, serious accidental injury, fires, or conditions that pose a threat to resident health and safety.  CMS Ex. 33 at 1-4.  The policy provides that if there is a reasonable suspicion that a crime has been committed against a resident, then not only the state agency, but one law enforcement entity must be notified not more than 24 hours after the suspicion forms, unless there is an injury, in which case a maximum of 2 hours is permitted for reporting.  CMS Ex. 33 at 6.

There is no allegation by CMS that Petitioner’s policy does not meet the requirement of 42 C.F.R. § 483.12(b).  The allegation is that Petitioner failed to implement its policy as reflected by the example of Resident 1 and her missing ring.  CMS Ex. 21 at 32.  It is apparent that when Resident 1’s visitor complained to staff on August 13, 2017 that Resident 1’s valuable ring was missing, staff did not recognize or treat the complaint as an allegation that the ring had been misappropriated even though the visitor threatened to call the police.  The evidence shows that ADON Hansen and Administrator Sims also did not recognize that there was an allegation of theft.  However, it strains credibility that even the most naïve would not recognize an allegation of theft or misappropriation has been made when someone complains that a valuable item has disappeared and threatens to call police.  ADON Hansen and Administrator Sims did not strike me as naïve.  Therefore, I find it more likely than not that they chose not to believe the allegation that Resident 1 had a valuable ring in the facility and/or that the ring was missing.  Whether the ring was missing through misappropriation or neglect does not control because a complaint was made that sounded like an allegation of theft or misappropriation and an allegation is all that is necessary to trigger Petitioner’s policy.  It is hard to understand how Administrator Sims did not understand, in the face of a threat to call law

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enforcement, that Resident 1’s visitor was alleging that Resident 1’s ring was stolen.  It is also difficult to understand why Administrator Sims did not recognize that treating the ring as stolen or misappropriated and contacting the state agency and law enforcement, as Petitioner’s policy required, was in the best interest of both Resident 1 and Petitioner.  Even if Administrator Sims did not believe Resident 1 had a ring that was stolen, it was in Petitioner’s best interest to have law enforcement sort that out.

There is no dispute that from August 13, 2017 to about September 15, 2017, just over 30 days, Petitioner’s staff did not implement its policy and contact the state agency and law enforcement.  I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.12(b).  The surveyor determined that the violation posed a risk for more than minimal harm.  Therefore, there is noncompliance that is a basis for the imposition of an enforcement remedy.

8.  A CMP of $6,394 per day from July 26 through August 11, 2017, a CMP of $1,255 per day for one day, on August 12, 2017, and a CMP of $105 per day from August 13 through October 10, 2017, are reasonable enforcement remedies.

I have concluded that Petitioner violated 42 C.F.R. §§ 483.60, 483.24-.25, 483.35(d)(7), 483.10(j)(2), and 483.12(b) and (c)(1) and that the violations amount to noncompliance because they posed a risk for more than minimal harm to one or more facility residents.  I have also concluded that Petitioner has failed to show that the declaration of immediate jeopardy for noncompliance under Tags F309 (42 C.F.R. § 483.24-.25) and F360 (42 C.F.R. § 483.60) was clearly erroneous during the period of July 26 through August 11, 2017.

When a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per day CMP for the number of days that the facility is not in compliance or for each instance that a facility is not in substantial compliance, whether the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).  Pursuant to 82 Fed. Reg. 9174 (Feb. 3, 2017), effective February 3, 2017, CMPs assessed on or after February 3, 2017, for noncompliance that occurred after November 2, 2015, are subject to higher amounts.  According to the table published in the Federal Register, the range of a per day CMP for immediate jeopardy noncompliance is $6,394 to $20,965 per day.  For all other noncompliance the range is $105 to $6,289 per day, and the range for a per instance CMP is $2,097 to $20,965, whether there is immediate jeopardy.  81 Fed. Reg. at 9182-83; 45 C.F.R. § 102.3 (Table).

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

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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 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 described in 42 C.F.R. § 488.404(b), the same factors CMS and the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including, but not limited to, the facility’s neglect, indifference, or disregard for resident care, comfort, and safety.  The absence of culpability is not a mitigating factor.

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

My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  Liberty Commons Nursing and Rehab – Almance, DAB No. 2070 (2007); 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).

In arguing that the remedies imposed are unreasonable, Petitioner asserts generally that it “did not commit any deficient practice” and that its actions “did not result in any resident harm.”  P. Br. at 22.  However, CMS established a prima facie case for the alleged noncompliance and Petitioner failed to offer sufficient evidence to rebut the prima facie case.  Petitioner also asserts that “the period of noncompliance was not properly calculated to determine the number of days to which any proposed penalty should apply.”  P. Br. at 22.  The Board has explained that the facility bears the burden of demonstrating that it returned to substantial compliance at a date earlier than that determined by CMS.  W. Tex. LTC Partners, Inc., DAB No. 2652 at 18 (2015) (citing Chicago Ridge Nursing Ctr., DAB No. 2151 at 26 (2008)); Cmty. Northview Care Ctr., DAB No. 2295 at 15 (2009).  Petitioner states in its plan of correction for the September 15, 2017 survey that it completed its plan of correction on October 11, 2017, and I find that is good evidence

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that the noncompliance was not finally corrected until that date – the day after CMS abated all enforcement remedies.  Petitioner has failed to meet its burden to show it returned to substantial compliance earlier than October 11, 2017.

I have received no evidence that Petitioner had a history of noncompliance prior to the surveys at issue.  Petitioner has not argued that its financial condition affects its ability to pay the proposed CMP.  I conclude that Petitioner’s deficiencies are serious, and that Petitioner was culpable for the reasons already described under the various citations of noncompliance.  The failure to ensure Resident 1’s special dietary needs were met resulted in his hospitalization for an allergic reaction.  Petitioner cannot shift its culpability to its computer software company.  Similarly, allegations of abuse and misappropriation are serious by nature, and failing to report allegations puts residents at risk of suffering further harm.  There is no excuse for the facility’s failure to follow its own specific written policies and procedures for reporting and investigating allegations of misappropriation and complying with its own grievance policies.

The CMP of $6,394 per day proposed by CMS for 17 days of immediate jeopardy, from July 26 through August 11, 2017, is the minimum amount authorized of immediate jeopardy, and I conclude it is reasonable based on my consideration of the regulatory factors.  I also conclude that the $1,255 CMP for one day on August 12, 2017 and the $105 per day CMP (the minimum authorized for non-immediate jeopardy noncompliance) proposed for the period of noncompliance from August 13 through October 10, 2017 are reasonable based on the regulatory factors.

III.  Conclusion

For the foregoing reasons, I conclude that:

Petitioner was not in substantial compliance with program participation requirements from July 26 through October 10, 2017,

The declaration of immediate jeopardy was not clearly erroneous; and

The enforcement remedies imposed are not unreasonable.

1. Citations are to the 2016 revision of the Code of Federal Regulations (C.F.R.) (as amended), unless otherwise indicated.  Good Shepard Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996).



In this case, the events for which noncompliance was alleged occurred from July through September 2017 and so the regulations with which Petitioner was bound to comply at that time were in the 2016 revision of the C.F.R. as it was amended effective November 28, 2016, when 42 C.F.R. pt. 483, was extensively revised with many of the participation requirements established by the regulations being moved and renumbered.  81 Fed. Reg. 68,688, 68,697 (Oct. 4, 2016).  The allegations of noncompliance in the Statements of Deficiency (SOD) for the surveys that ended on August 12 and September 15, 2017 cite the regulations as revised effective November 28, 2016.  I conclude that the new regulations effective November 28, 2016, apply under the Board’s rationale in Good Shepherd, Carmel,and the cases cited therein.  The new regulations are published in the 2017 revision of the C.F.R.

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2. CMS offered new evidence for the first time in its post-hearing briefs related to shellfish allergies.  In its argument regarding the immediate jeopardy determination, CMS cited information found on the websites for the Mayo Clinic and the American College of Allergy, Asthma & Immunology.  CMS Br. at 9 nn. 8-9; CMS Reply at 6 nn.4-5.  CMS did not offer this evidence prior to hearing as required by the Standing Order.  CMS offered no expert testimony related to the information available at these websites.  CMS also failed to request leave by a proper motion to offer this evidence post-hearing.  Accordingly, I do not consider such evidence in my review of the immediate jeopardy determination, or for any other purpose.
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3. SNFs and NFs are often referred to as long-term care facilities or nursing homes.  NF participation in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.
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4. Effective February 3, 2017, CMS increased the CMP amounts to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).
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5. Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.
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6. “Credible evidence” is evidence that is worthy of belief.  Black’s Law Dictionary 596 (18th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
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7. This is a “Tag” designation.  As already noted, CMS extensively revised the regulatory participation requirements in 42 C.F.R. pt. 483, effective November 28, 2016.  81 Fed. Reg. 68,688, 68,697.  However, CMS did not issue its revised CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (available at www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs) that addressed the revised regulations until November 22, 2017 (SOM, rev. 173, eff. Nov. 22, 2017).  The revised SOM changed the numbering of the F-Tags.  Therefore, when the surveyors conducted the survey in this case, the SOM available to the surveyors for guidance did not correlate to the new regulations.  In the SOD, the surveyors cite to the F-Tags from the prior SOM (rev. 168, eff. Mar. 8, 2017) that related to the old regulations.  In the SOD, the surveyors cite the new regulations under the F-Tags from the prior SOM that related to the prior regulations.  Although confusing, I concluded it was unnecessary to send this case back to CMS for correction of the SOD to refer to the new F-Tags from the revised SOM as there is no substantive impact in deciding this case.  The F-Tag generally refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors for identifying compliance or noncompliance.  Whether or not the F-Tags from the prior SOM accurately state CMS policy regarding the new regulations at the time of the survey is not an issue that the parties have raised in this case.  Furthermore, the SOM is not promulgated in accordance with section 1871(a)(1)‑(2) of the Act and does not have the force and effect of law, although the 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 may not seek to enforce the provisions of the SOM as law, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.  The new regulations and not the SOM control the decision in this case.
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8. Scope and severity levels are used by CMS and a state when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in SOM, ch. 7, § 7400.5.1 (rev. 63, Sep. 10, 2010).  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is not considered “noncompliance,” and which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I, indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L indicate deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and which are optional at each level based upon the frequency of the deficiency.
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9. I do not consider this fact to be an admission by Petitioner of any deficiency.
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10. Petitioner is required to have a Quality Assessment and Performance and Improvement (QAPI) program.  42 C.F.R. § 483.75(a).  Petitioner is required to have a Quality Assurance and Assessment (QAA) committee as part of its QAPI program.  42 C.F.R. § 483.75(g).
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11. Petitioner cites to 42 C.F.R. § 483.75(o), a prior version of the regulation.  The correct citation is 42 C.F.R. § 483.75(h)-(i) which provides:



(h) Disclosure of information.  A State or the Secretary may not require disclosure of the records of such committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section.

(i) Sanctions.  Good faith attempts by the [QA] committee to identify and correct quality deficiencies will not be used as a basis for sanction.

(emphasis added).

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12. Decisions often cited include:  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 7 (2012); Liberty Health & Rehab of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Britthaven of Havelock, DAB No. 2078 (2007); Daughters of Miriam Ctr., DAB No. 2067 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726 at 39.
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13. The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard.  However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.
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14. Appendix Q of the SOM in effect at the time of the survey of Petitioner also failed to provide surveyors a working definition of the term “serious” that they could use to determine whether harm, injury, or impairment is serious when deciding whether or not to declare immediate jeopardy.  The Act does not define the phrase “immediately jeopardize” and does not introduce the concept of serious harm, injury, or impairment as the basis for finding immediate jeopardy.  Thus, one is not in error concluding that, absent a definition of the term “serious” in the Act, the regulations, the SOM, or decisions of the Board, it is essentially up to individual surveyors, and whatever unpublished guidance they receive from their superiors or CMS officials, to exercise their individual discretion and judgment to decide that there was immediate jeopardy, which subjects a facility to the maximum imposable CMPs.
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15. On the immediate jeopardy issue, CMS asserts that shellfish is among the most common food allergens and that reactions can be severe and life-threatening.  CMS Br. at 9; CMS Reply at 6.  In support of these arguments, CMS refers to information found on the websites for the Mayo Clinic and the American College of Allergy, Asthma & Immunology.  CMS Br. at 9 n.8-9; CMS Reply at 6 n.4-5.  CMS cited these websites for the first time in footnotes to its post-hearing brief and post-hearing reply brief and thus attempted to introduce that evidence after the exchange deadlines had passed and the after the hearing in this case.  I do not consider such evidence in my review of the immediate jeopardy determination.  Ultimately, excluding that evidence has no effect on the outcome in this case as the burden remains on the facility, not CMS, to show that the immediate jeopardy determination was clearly erroneous.  Cal Turner Extended Care Pavilion, DAB No. 2384 at 14-15; Liberty Commons Nursing & Rehab. Ctr. – Johnston, 241 F. App’x 76 at 3-4.  Counsel is cautioned that procedures for the introduction and admission of documentary evidence must be followed and that failure to do so may result in sanctions.
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16. The SOD also cites 42 C.F.R. § 483.10(j)(3) and (4), however the facts alleged do not reflect a violation of those subparagraphs.
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17. The SOD also cited 42 C.F.R. § 483.12(a)(3) and (4) and (c)(3) and (4), however the facts alleged do not reflect a violation of those subparagraphs.
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18. Resident 1 is not the same resident as the Resident 1 involved in the August 2017 survey.
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19. I do not consider the examples of the other residents cited under Tags F166, F225, and F226.  Consideration of the other residents is unnecessary given that the alleged noncompliance is amply demonstrated by the example of Resident 1 alone.  For purposes of assessing the reasonableness of the CMP imposed based on the noncompliance under Tags F160, F225, and F226, I also consider only the example of Resident 1, as the example of Resident 1 is sufficient alone as a basis for the imposition of a CMP at the very lowest end of the range of authorized CMPs.
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20. Petitioner’s policy is very similar to the state agency policy set forth in Provider Letter No. 17-18 dated May 3, 2017.  CMS Ex. 37.  The state agency policy also requires that Petitioner report to the state agency any alleged misappropriation of resident property within 24 hours of receipt of the allegation.  CMS Ex. 37 at 5, 9.  The breadth of the state policy is demonstrated by the fact that it specifically lists only two events that need not be reported to the state agency:  (1) theft of facility property other than drugs; and (2) theft of any property other than drugs that is not the property of a resident.  CMS Ex. 37 at 11.
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21. The state agency definition of misappropriation is the



[T]aking, secretion, misapplication, deprivation, transfer, or attempted transfer to any person not entitled to receive any property, real, or personal, or anything of value belonging to or under the legal control of a resident without the effective consent of the resident or other appropriate legal authority or the taking of any action contrary to any duty imposed by federal or state law prescribing conduct relating to the custody or disposition of property of a resident.

CMS Ex. 37 at 5.

The CMS definition of misappropriation is

Misappropriation of resident property means the deliberate misplacement, exploitation, or wrongful, temporary, or permanent use of a resident’s belongings or money without the resident’s consent.

42 C.F.R. § 483.5 (italics original).  Although the CMS definition is not as clear as the state definition, under both definitions an unlawful taking or theft of resident property results in misappropriation of resident property.

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