San Pedro Manor, DAB CR5535 (2020)

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

San Pedro Manor,
(CCN: 455689),

v.

Centers for Medicare & Medicaid Services

Docket No. C-16-161
Decision No. CR5535
February 14, 2020

DECISION

Petitioner, San Pedro Manor, was not in substantial compliance with program participation requirements from September 9 through 13, 2015, due to its violation of 42 C.F.R. § 483.251 (Tag F3092 ). There is a basis for imposing a $6,050.00 per day civil

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monetary penalty (CMP) effective September 9 through 13, 2015, and that enforcement remedy is reasonable.

I. Background

Petitioner is located in San Antonio, Texas and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF). Joint Stipulations (J. Stip.) ¶ 1. On September 17, 2015, the Texas Department of Aging and Disability Services (state agency) completed a survey of Petitioner and concluded that Petitioner was not in substantial compliance with program participation requirements. J. Stip. ¶¶ 2‑3; Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 3. The only deficiency cited by the survey was noncompliance with 42 C.F.R. § 483.25 (Tag F309) that allegedly posed immediate jeopardy from September 9 through 13, 2015. J. Stip. ¶ 4; CMS Ex. 3. CMS notified Petitioner by letter dated December 18, 2015, that it was imposing a CMP of $6,050.00 per day effective September 9 through September 13, 2015. J. Stip. ¶ 7; CMS Ex. 1 at 1.

Petitioner requested a hearing before an administrative law judge (ALJ) on November 30, 2015. The case was assigned to me for hearing and decision on December 22, 2015, and an Acknowledgment and Prehearing Order was issued at my direction. On December 5 and 6, 2017, a hearing was convened by video teleconference and a transcript of the proceedings was prepared.3 CMS offered CMS Exs. 1 through 24. Tr. Day 1 at 27. CMS Exs. 1 through 7, 9 through 14, 18, and 22 through 23 were admitted as evidence. Tr. Day 1 at 27-29, 67-70, 72-88. Petitioner offered P. Exs. 1 through 12 and P. Exs. 1 through 9 were admitted. Tr. Day 1 at 89-93.

CMS called the following witnesses to testify at the hearing: Surveyor Sourykanh Phanhtharath, RN (Registered Nurse) and Daniel McElroy, RN, CMS Nurse Consultant. Petitioner called the following witnesses: Raul Espinosa, Jr., Petitioner's Administrator during the survey and at the time of the hearing, and Julie A. Sulik, RN , Vice-President of Clinical Operations and Services for Southwest Long‑Term Management, Petitioner's parent company.

CMS filed its post‑hearing brief (CMS Br.) on February 26, 2018. Petitioner filed its post‑hearing brief (P. Br.) on February 27, 2018. CMS filed a reply brief (CMS Reply)

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and proposed findings of fact and conclusions of law on March 28, 2018. Petitioner also filed its reply (P. Reply) on March 28, 2018.

II. Discussion

A. Issues

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

Whether the remedy imposed is reasonable.

B. Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and at 42 C.F.R. pt. 483. Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.4 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 the date noncompliance began. 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 the date noncompliance began – commonly referred to as the mandatory or statutory 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 180 days of noncompliance. The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and other remedies such as a directed plan of correction. Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk

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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. Noncompliance refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance, i.e., a deficiency that poses a risk for more than minimal harm. 42 C.F.R. § 488.301. Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

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. The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). "Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301 (emphasis in original). The lower range of CMPs, $50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

The Act and regulations make a hearing before an ALJ available to a long-term care facility 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 would impact the facility's authority to conduct a nurse aide training and competency evaluation program. 42 C.F.R. § 498.3(b)(14), (d)(10)(i). The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, "must be upheld unless it is clearly erroneous." 42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9 (2000), aff'd, Woodstock Care

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Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003). The Departmental Appeals Board (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).

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

The allocation of the burden of persuasion and the quantum of evidence required to meet the burden is not addressed by regulations.5 Rather, the Board has long held that the petitioner, the nongovernmental party, bears the 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

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(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 only when CMS makes a prima facie showing of noncompliance, is the facility burdened 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 specified how much 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 a prima facie case of noncompliance with a regulatory requirement." Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904. "Prima facie" means generally that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8th ed. 2004). One might conclude that if 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, that is, CMS should be burdened to present evidence sufficient to establish a fact as more likely true and to raise a presumption. However, the Board has never ruled that CMS must establish its prima facie case by a preponderance of the evidence. Indeed, 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, I conclude that CMS has made its prima facie showing 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, though not all may be specifically discussed in this decision. I discuss in this decision the credible evidence given the greatest weight in my decision-making.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., Admin. L. and Prac. § 5:64 (3d ed. 2013).

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1. Petitioner violated 42 C.F.R. § 483.25 (Tag F309).

2. The violation of 42 C.F.R. § 483.25 (Tag F309) posed a risk for more than minimal harm and amounted to noncompliance.

The cited deficiency in this case involves one resident, Resident 5. The facts related to what happened with Resident 5 are not in dispute. CMS argues that the facts establish a prima facie showing of noncompliance based on a violation of the requirement to provide Resident 5 quality care as required by 42 C.F.R. § 483.25. Petitioner argues it should not be liable for its employee's failure to provide cardiopulmonary resuscitation (CPR) for Resident 5 immediately upon discovering the resident without heartbeat or respiration. Petitioner argues in the alternative that, even if it is responsible for its employee's failure to act, the surveyors in citing the noncompliance and CMS in making its prima facie showing, relied upon information that is privileged and confidential under state and federal law and may not be considered when citing noncompliance. Finally, Petitioner argues that the noncompliance, if found, was already corrected by Petitioner and there is no basis for liability or for an enforcement remedy to be imposed against Petitioner.

a. Facts

Petitioner states in its prehearing brief that Resident 5 was 52 years old and had been admitted to Petitioner numerous times related to her severe uncontrolled diabetes. In November 2014, she was admitted to Petitioner because she was experiencing falls and could no longer care for herself. P. Br. at 4.

Resident 5's care plan dated June 24, 2015, specified that she was full code and that staff was to perform cardiopulmonary resuscitation (CPR) and call 911 (emergency medical services (EMS)) consistent with her request for full code status. CMS Ex. 11. On September 8, 2015, Resident 5 was placed in isolation and her roommate was moved out of the room on suspicion that Resident 5 had clostridium difficile. CMS Ex. 12.; P. Ex. 6 at 3.

A nurse's note dated September 9, 2015 with the time "5:15," shows that when a nurse delivered the resident's scheduled medication, Resident 5 was not responsive and without vital signs. The note does not indicate the time when the resident was found. The note indicates that the resident's son and mother were called at about 4:25 a.m.; another person named "Ella" was called at 4:21 a.m. The note states "[c]alled RN Susie to start CPR and called 911," but the time of the calls is not noted. CMS Ex. 12 at 2; P. Ex. 6 at 2. The note states EMS arrived at 4:50 a.m. but "no rescue action [was] performed." CMS Ex. 12 at 2; P. Ex. 6 at 2. The note also states a police officer came to investigate. The note bears the initials "W.C." CMS Ex. 12 at 2; P. Ex. 6 at 2. Based on Petitioner's brief (P. Br. at 3) and the police report (CMS Ex. 14), there is no dispute that "W.C." is Licensed Vocational Nurse (LVN) Wei (Bill) Chu. The nurse's note bears the time 5:15

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but does not indicate whether it was a.m. or p.m. I infer based on the context of the times reported in the note that the note was most likely written about 5:15 a.m.

CMS placed the police report in evidence as CMS Ex. 14. The report, which lists a date and time of the occurrence as September 9, 2015, from 4:10 a.m. to 4:51 a.m., indicates that the police officer interviewed LVN Wei Chu, who was identified as Resident 5's caregiver. LVN Chu stated Resident 5 had gone downstairs to smoke at about 3:30 a.m. and later returned to her room. LVN Chu stated that when he checked Resident 5 at about 4:10 a.m. she was not responsive and not breathing. The police officer also reported that the firefighter on scene reported that Resident 5 was pronounced dead at 5:04 a.m. CMS Ex. 14 at 4.

Facts recited by Petitioner in its prehearing brief corroborate Resident 5's care plan and statements in the police report and nurse's notes. Around 3:30 a.m. on September 9, 2015, Resident 5 was seen in the elevator returning to her room following smoking without any apparent problem. Between 4:10 a.m. and 4:15 a.m., LVN Chu went to Resident 5's room to give her scheduled medication. LVN Chu found the resident unresponsive in her bed. LVN Chu had Certified Nurse Aide (CNA) Dorothy Bates check Resident 5's vital signs and she had none. LVN Chu did not start CPR but left the resident's room to go for help. LVN Chu then spoke with RN Rodriguez about who should be notified when a non-hospice resident dies and RN Rodriguez responded that the physician and family should be called. LVN Chu called Resident 5's physician and family and then called the Assistant Director of Nursing (ADON). After LVN Chu spoke to the ADON he returned to Resident 5's room and began CPR. Petitioner admits that there was a delay of at least 10 minutes between LVN Chu's discovery of the unresponsive Resident 5 and the initiation of CPR.7 P. Br. at 4-5. Petitioner does not dispute that LVN Chu should have started CPR on Resident 5 immediately and that he was not authorized to declare the resident dead. Tr. Day 1 at 50, 99, 106; P. Br. at 2.

Petitioner had CPR policies applicable to both LVNs and CNAs, which were in effect at the time of the death of Resident 5. P. Ex. 3; CMS Ex. 23; Tr. Day 2 at 134. Both policies provide that if a CNA or LVN finds a patient nonresponsive upon entering a room, the following actions are required:

1. Check pulse and respiration;
2. Ask patient if he or she is okay;

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3. Tap or gently shake the resident to see if he or she responds;
4. If nonresponsive, yell out for help and go to the hallway and yell code blue;
5. Establish code status, if full code immediately start chest compressions, have someone call 911, and get the crash cart and automatic external defibrillator in the room; and
6. Continue CPR until EMS arrives and takes over.

CMS Ex. 23 at 1-2.

The only difference between the LVN and CNA CPR policies is that the CNA may only perform CPR if the CNA is CPR-certified. If the CNA is CPR-certified, the policy instructs the CNA not to wait for a nurse to commence CPR. CMS Ex. 23 at 1-2.

b. Analysis

The surveyor alleged in the Statement of Deficiencies (SOD) for the survey completed on September 17, 2015, that Petitioner violated 42 C.F.R. § 483.25 and that the violation posed immediate jeopardy. CMS Ex. 3 at 1-2. More specifically, the surveyor alleged that Petitioner violated the regulation because "LVN A [LVN Chu] did not immediately initiate [CPR] for resident #5 until approximately 15 minutes after she was found pulseless and without respiration." CMS Ex. 3 at 2. The surveyor alleged in the SOD that the noncompliance posed immediate jeopardy for 23 of Petitioner's residents who also had full code orders because they too might not have CPR initiated immediately. The surveyor alleged that the noncompliance occurred on September 9, 2015, and continued through September 13, 2015; and that Petitioner corrected the noncompliance effective September 14, 2015. CMS Ex. 3 at 2. The surveyor referred to a CNA being in the room with LVN Chu, but did not specifically state that the CNA's failure to initiate CPR or call for immediate assistance was a violation of a regulation. CMS Ex. 3 at 3.

In its prehearing and post-hearing briefs, CMS clearly indicates it is proceeding on the theory that neither LVN Chu nor CNA Bates initiated CPR, called EMS, or took other appropriate action in accordance with Resident 5's care planned request for full code status. CMS Prehearing Brief at 7, 11; CMS Br. at 8, 12-13. Therefore, Petitioner cannot ignore or deny that the CMS theory before me is broader than the specific findings and conclusions of the surveyor. However, Petitioner focuses on LVN Chu, arguing that he is the only employee involved, and does not address CNA Bates. P. Br. at 1-2, P. Reply at 2-3. Petitioner argues that LVN Chu was "one 'errant' employee," and that there was no systemic failure in Petitioner's administration and operation. P. Br. 13. It is troubling that Petitioner clearly fails to appreciate that because both LVN Chu and CNA Bates failed to act to fulfill Resident 5's care plan for full code status, there is strong evidence that Petitioner had a systemic failure to ensure code status was followed strictly for all residents who were care planned for full code. Petitioner's arguments before me suggest that Petitioner has yet to recognize the magnitude of its noncompliance. It is also clear

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that Petitioner has failed to accept that its staff training prior to the incident involving Resident 5, which is described in Petitioner's brief (P. Br. at 13-14), was simply not effective for at least two employees, LVN Chu and CNA Bates.8

Petitioner argues that "[t]here are specific tags for past noncompliance, but a 'current' F309 tag is not among them . . . . On this basis alone, the F309 tag should be deleted." P. Br. at 6 (footnote deleted). Petitioner cites no authority supporting its position or any analysis to help understand Petitioner's reasoning. I conclude Petitioner's argument is not persuasive. Therefore, Tag F309 is not deleted as urged by Petitioner.

I conclude that Petitioner had adequate notice of the noncompliance at issue in this case. Petitioner was not prejudiced by the lack of clarity in the SOD regarding the conduct at issue. I also conclude that Petitioner has failed to identify any legal bar to CMS proceeding on the citation of noncompliance under Tag F309. Therefore, it is necessary to determine whether CMS made a prima facie showing of noncompliance under Tag F309 based on a violation of 42 C.F.R. § 483.25.

The opening provision of 42 C.F.R. § 483.25, which implements section 1819(b)(2) of the Act, requires that each participating facility ensure that:

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, in accordance with the comprehensive assessment and plan of care.

The quality of care legislation and regulatory requirements are "based on the premise that the facility has (or can contract for) the expertise to first assess what each resident's

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needs are (in order to attain or maintain the resident's highest practicable functional level) and then to plan for and provide care and services to meet the goal." Spring Meadows Health Care Ctr., DAB No. 1966 at 16 (2005). The facility must "take all practicable measures to achieve that regulatory end." Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 21 (2004), aff'd, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App'x 900 (6th Cir. 2005). The Board has concluded that the language of 42 C.F.R. § 483.25 not only requires SNFs to furnish the care and services set forth in a resident's care plan but also to implement doctors' orders, monitor and document the resident's condition, and follow its own policies. See, e.g., Alexandria Place, DAB No. 2245 (2009) (upholding deficiency when a petitioner did not provide care in accordance with a doctor's order); Oxford Manor, DAB No. 2167 at 5‑6 (2008) (facility policy is evidence of the standard of care). The quality of care provision also implicitly imposes on facilities a duty to provide care and services that, at a minimum, meet accepted professional standards of quality "since the regulations elsewhere require that the services provided or arranged by the facility must meet such standards." Spring Meadows, DAB No. 1966 at 17; 42 C.F.R. § 483.20(k)(3).

Under the rubric adopted by the Board for the allocation of the burden of proof and persuasion, the first step in judging the merits is to determine whether CMS has made a prima facie case that Petitioner failed to comply with or, in other words, violated the requirement of 42 C.F.R. § 483.25 (Tag F309). Petitioner objects to the citation of deficiency on grounds that information used by the surveyor and CMS in citing noncompliance is protected by a form of privilege that Petitioner argues is derived from state and federal law related to the quality assurance process, which I refer to as Petitioner's quality assurance defense. My review is de novo. Therefore, I am required to take a fresh look at the evidence. In light of Petitioner's quality assurance defense, I first consider whether the evidence that is clearly not subject to the defense is sufficient to make a prima facie showing of noncompliance and conclude that it is.

The findings of fact set forth above related to what happened with Resident 5 during the morning of September 9, 2015, are based on the care plan for Resident 5 (CMS Ex. 11), the police report (CMS Ex. 14), and the nurse's note (CMS Ex. 12 at 2, P. Ex. 6 at 2). The care plan was dated June 24, 2015, and clearly predates any possible quality assurance activities related to Resident 5's death. The police report was written by a police officer based on information he collected, not information collected as part of a quality assurance effort by Petitioner. Further, the police officer investigated very near the time of Resident 5's death, which was more likely than not, before any quality assurance effort was initiated by Petitioner. The nurse's note was written by LVN Chu about 5:15 a.m. on September 9, 2015, shortly after he found Resident 5 unresponsive and, more likely than not, before any quality assurance effort was initiated by Petitioner. Petitioner concedes that clinical records, such as this nurse's note, are not subject to Petitioner's asserted privilege. P. Br. at 11. Thus, even if I were to conclude that Petitioner's quality assurance defense had some merit, I conclude it does not apply to

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these three key pieces of evidence, which are more likely than not, not a product of Petitioner's quality assurance process. The evidence shows that Petitioner created a care plan for Resident 5 that recognized that she wanted to be resuscitated, including by the use of CPR. Pursuant to 42 C.F.R. § 483.25, Petitioner was required to ensure that Resident 5 received the care and services required by her care plan, in this case CPR. The police report and the nurse's note confirm that LVN Chu and CNA Bates did not start CPR on Resident 5 immediately as required by Petitioner's policies (CMS Ex. 23 at 1-2) when they determined she had no heartbeat or respiration at about 4:10 a.m. Rather, they waited to initiate CPR, until approximately 4:20 to 4:30 a.m., after LVN Chu reported he made telephone calls. CMS Ex. 12 at 2; P. Ex. 6 at 2. Therefore, Petitioner failed to ensure that Resident 5 received the care and services required by her care plan from either LVN Chu or CNA Bates. I conclude that the evidence, which is not subject to Petitioner's quality assurance defense,9 is clearly sufficient to establish the CMS prima

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facie showing of a violation of 42 C.F.R. § 483.25. The Board has not specified the quantum of evidence CMS must produce to make its prima facie showing. However, in this case CMS has shown it more likely than not, i.e., by a preponderance of the evidence, that Petitioner failed to ensure Resident 5 received CPR as required by her care plan.

CMS made a prima facie showing. Hence, the burden is upon Petitioner to show by a preponderance of the evidence that it did not violate 42 C.F.R. § 483.25 or, that it has an affirmative defense.

Petitioner argues that it should not be liable for the violation of 42 C.F.R. § 483.25 because Petitioner had ensured that LVN Chu was trained and yet, he acted contrary to his training and Petitioner's policy. P. Br. at 2, 13‑14; P. Reply at 2‑3. A problem with this theory for Petitioner is it does not address why CNA Bates, who was clearly present, also failed to initiate CPR immediately. Petitioner does not allege that CNA Bates was not CPR-qualified and offers no excuse for her failure to act. In fact, RN Sulik testified that CNA Bates was CPR-certified. Tr. Day 2 at 134-35. Even if CNA Bates was not CPR-certified and per Petitioner's policy had to wait for a nurse, there is no explanation for why she failed to seek qualified assistance immediately when LVN Chu left her alone with Resident 5. Therefore, I conclude it is not necessary to address Petitioner's argument that it should have no liability for LVN Chu's failure to act. Clearly, LVN Chu was not the "rogue employee" as Petitioner characterized him to be, who inexplicably departed from Petitioner's training and policy. CNA Bates, whose inaction was never

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addressed by Petitioner, also failed to initiate CPR or seek assistance immediately for Resident 5, indicating that she too was not trained or not effectively trained.10

Petitioner argues that if there was a violation of 42 C.F.R. § 483.25 that amounted to noncompliance, i.e., it posed a risk for more than minimal harm, it is not a basis for a citation of noncompliance because the conduct at issue was corrected before the state survey took place. P. Br. at 5-6; P. Reply at 18-19. Petitioner objects that "no specific past non‑compliance tag was cited; instead, the facility was cited for a 'current' F309 citation which [the surveyor] denoted as 'past noncompliance' in the body of the report." P. Br. at 6. There is no dispute that Petitioner was in substantial compliance at the time of the survey, which is confirmed by the fact Petitioner was not required to submit a plan of correction. CMS Ex. 3 at 6-7; P. Br. at 6 n.1. Petitioner reasons that, to the extent there was a deficiency, it had already been addressed by the QA committee and should not have been the basis for a deficiency citation. Petitioner cites no authority in support of its position. Indeed, Petitioner's argument is clearly in conflict with the Act. The Act specifically provides that even if the state agency concludes that a SNF is in substantial compliance at the time of a survey, but was not in substantial compliance for a period prior to the survey, the Secretary is authorized to impose a CMP for the number of days of noncompliance. Act § 1819(h)(2)(A). I conclude that the Secretary and his delegate, CMS, have statutory authority to impose a CMP for failure to meet participation requirements during a period prior to the current survey. Act § 1819(h)(2)(A). Pursuant to 42 C.F.R. § 488.430(b), CMS may impose a CMP "for the number of days of past noncompliance since the last standard survey, including the number of days of immediate jeopardy." In North Ridge Care Ctr., DAB No. 1857 (2002), the Board recognized that

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the Secretary and CMS have the discretion to impose CMPs for past noncompliance with the participation requirements that occurred between standard surveys, but CMS may reach back no further than the last standard survey. CMS policy as set forth in the SOM provides additional guidance on past noncompliance scenarios. The SOM provides that past noncompliance must have occurred after the exit date of the last standard survey and before the current survey and the current survey must show that the noncompliance has been corrected. SOM, CMS Pub. 100‑07, Ch. 7 § 7510.1. The SOM requirements are met in this case. It is clear that CMS has the authority to impose a penalty for past noncompliance that has already been corrected and Petitioner's argument to the contrary has no merit.

Petitioner argues that imposing a CMP on the facts is inconsistent with 42 C.F.R. § 488.402(a), which states the purpose of an enforcement remedy is to ensure prompt return to compliance with program requirements. The poorly drafted regulation provides Petitioner no relief, however, because inherent in the concept of prompting return to compliance is the goal of ensuring continuing compliance once prompt compliance is attained. Congress clearly intended for authorized enforcement remedies to not only prompt return to substantial compliance but also to ensure compliance is maintained. See Act § 1819(h)(2)(E); CarePlex of Silver Spring, DAB No. 1627 at 10 (1997) (purpose of enforcement remedies is to "enhance care to residents and encourage compliance and prompt correction"); Regency Gardens Nursing Ctr., DAB No. 1858 at 11 (2002) (purpose of CMP is to encourage facilities to attain and maintain substantial compliance).

I conclude that Petitioner has failed to rebut the CMS prima facie case or to establish an affirmative defense by a preponderance of the evidence. Accordingly, I conclude that there is a basis for imposing a CMP.

3. The declaration of immediate jeopardy related to the noncompliance based on the violation of 42 C.F.R. § 483.25 (Tag F309) was not clearly erroneous.

The surveyor concluded that the violation of 42 C.F.R. § 483.25 posed immediate jeopardy beginning on September 9 and continuing through September 13, 2015. CMS imposed a CMP of $6,050.00 for each of the five days of noncompliance. CMS Ex. 2 at 1.

Petitioner bears a heavy burden under the regulations when challenging a declaration of immediate jeopardy. Unlike the issue of whether there is noncompliance, the Secretary has by regulation imposed the burden of persuasion on Petitioner to show that the declaration of immediate jeopardy was in error not by a preponderance of the evidence, but by a showing that the declaration was clearly erroneous. The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous. 42 C.F.R. § 498.60(c)(2). CMS's determination o f

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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 is clearly erroneous." Cal Turner, DAB No. 2384 at 14-15 (citing Liberty Commons, 241 F. App'x 76, at 80-81).

"Immediate jeopardy" under the regulations refers to "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 in original). In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, 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)(ii).

Many appellate panels of the Board have addressed "immediate jeopardy."11 In Miss. Care Ctr. of Greenville, the Board commented:

CMS's determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove

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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).

DAB No. 2450 at 15 (2012). 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), 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

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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. 56,116, 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 Center, Daughters of Miriam Center, 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. Giving deference 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 Center,that panel of the Board states 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 Center 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 United States Supreme Court has addressed the "clearly erroneous standard" in the context of the Administrative Procedure Act (APA).

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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 & Prods. of Cal., Inc. v. Constr. 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. Consol. Edison Co. of New York v. NLRB, 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. U.S. 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.12 Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

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 (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff'd, Life Care Ctr. of Tullahoma v. Sec'y of U.S. Dep't of Health & Human Servs., 453 F. App'x 610). 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 suggested by such terms as possible or potential. Daughters of

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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 may be. 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 School, that the regulations do not define or explain the meaning of the term "serious" as used in the definition of immediate jeopardy.13 DAB No. 2422 at 8. The 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 Center, 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 notes 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, or 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

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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, I have no definite and firm conviction that an error has been committed either by the declaration of immediate jeopardy, the scope and severity determination, or the period of immediate jeopardy from September 9 through 13, 2015. Petitioner failed to provide necessary care to Resident 5 when LVN Chu and CNA Bates failed to provide CPR as required by the resident's care plan. Petitioner's noncompliance posed immediate jeopardy to Resident 5 and as many as 23 residents who were care planned for full code at the time and highly likely to be subjected to serious harm or death in the event Petitioner's staff failed to ensure those residents' care plans for full code were fulfilled. Petitioner has clearly not shown that the incident was not serious under any reasonable definition of serious.

Petitioner argues that the scope and severity designation of immediate jeopardy is clearly erroneous and should be lowered. P. Br. at 14. Petitioner first argues that a "Level K citation should not stand because . . . this citation involves only one resident and one incident" which "is not enough to constitute a 'pattern' finding, particularly when no other residents were found to have been affected by the allegedly deficient practice." P. Br. at 14. Multiple residents were at risk and the involvement of at least two of Petitioner's staff show that this was not simply an isolated incident involving one resident and one staff member.

Appendix Q of the SOM includes CMS guidance to surveyors on how to identify immediate jeopardy. Petitioner argues that two of the three elements specified by the SOM Appendix Q, immediacy and culpability, are not present here. P. Br. at 15. Petitioner's reliance on SOM Appendix Q is misplaced before me. Appendix Q is a guide for surveyors in how to apply a regulatory standard; it does not define that standard nor is it 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 in Appendix Q, even if shown, are a basis to conclude that the declaration of immediate jeopardy is clearly erroneous.

Viewing the record as a whole, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the noncompliance cited under 42 C.F.R. § 483.25 (Tag F309) during the period of September 9 through 13, 2015, was clearly erroneous.

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4. A $6,050.00 per day CMP for the period September 9 through 13, 2015, is a reasonable enforcement remedy.

I have concluded that Petitioner was not in substantial compliance with the participation requirement established by 42 C.F.R. § 483.25 (Tag F309). I have also concluded that Petitioner has not shown that the declaration of immediate jeopardy related to the noncompliance was clearly erroneous. If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP. CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy. 42 C.F.R. § 488.430(a). The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. §§ 488.408, 488.438. The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies. 42 C.F.R. § 488.438(a)(1)(i), (d)(2). The lower range of CMPs, $50 per day to $3,000 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm. 42 C.F.R. § 488.438(a)(1)(ii).

CMS proposed a $6,050.00 per day CMP for the period September 9 through 13, 2015. I conclude that a CMP in the upper range of CMPs authorized for immediate jeopardy is appropriate in this case.

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: (1) I may not set the CMP at zero or reduce it to zero, (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP, and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount. In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered: (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility's degree of culpability, including but not limited to the facility's neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor. The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b): (1) whether the deficiencies caused no actual harm but had the potential for minimal harm; no actual

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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 or 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. 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).

Petitioner argues that the "imposition of a monetary penalty in excess of $30,000 is not justified, especially when the surveyor correctly concluded during his first exit conference that there was no deficient practice." P. Br. at 18. In support of its position, Petitioner reiterates its arguments concerning past noncompliance, its quality assurance defense, and that the incident occurred due to the actions of a "rogue employee." P. Br. at 2, 18‑19; P. Reply at 20‑24.

In determining the reasonableness of the proposed CMP, I am to consider the per day amount and number of days of noncompliance, not, as Petitioner argues, the total amount of the CMP. Century Care of Crystal Coast, DAB No. 2076 at 26 (2007). I have explained why Petitioner's arguments regarding past noncompliance, its quality assurance defense, and its rogue employee theory are not persuasive and there is no need to repeat the discussion. Petitioner's arguments are no more persuasive as they pertain to the reasonableness of the CMP than they were for the deficiency citation at issue. Moreover, Petitioner does not contend that any particular regulatory factor that I must consider does not support the CMP. Coquina Ctr., DAB No. 1860 at 18 (2002).

The deficient practice in this case was serious because Petitioner failed to ensure staff administered CPR and called EMS upon finding Resident 5 without vitals and knowing she was full code. Petitioner's failure to properly administer CPR placed 23 other residents who were full code at the time at risk. Furthermore, both LVN Chu and CNA Bates failed to take appropriate action on discovering Resident 5 had no vital signs. There was a clear breakdown in Petitioner's system. Even if I accept Petitioner was not culpable, the absence of culpability is not mitigating. Petitioner has presented no evidence of its financial status. There is no evidence of a history of noncompliance under Tag F309. The CMP proposed by CMS, which is just above the middle of the higher range of CMPs authorized for immediate jeopardy noncompliance, is modest given Petitioner's serious noncompliance. I therefore conclude that the $6,050.00 per day CMP proposed by CMS for the five days of immediate jeopardy is reasonable.

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III. Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from September 9 through September 13, 2015. There is a basis for imposition of a per day CMP of $6,050.00, which is reasonable.

/s/

Keith W. Sickendick Administrative Law Judge

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San Pedro Manor, DAB CR5535 (2020)

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

San Pedro Manor, (CCN: 455689),

v.