Magnolia Manor - Greenville, DAB CR5778 (2020)

DECISION

Petitioner, Magnolia Manor – Greenville, was not in substantial compliance with program participation requirements from June 10 through July 15, 2016, and from December 12, 2016 through January 9, 2017.  Petitioner was not in substantial compliance due to violations of 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25(h) that posed immediate jeopardy, and 42 C.F.R. §§ 483.10(b)(4), 483.25(a)(3), 483.25(e)(2), 483.35(i), and 483.75(o)(1) that posed a risk for more than minimal harm.1  There is a

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basis for the imposition of enforcement remedies.  The following enforcement remedies are reasonable:  a civil money penalty (CMP) of $7,291 per day from June 10 through July 15, 2016, and a CMP of $303 per day from December 12, 2016 through January 9, 2017.

I.  Background

Petitioner is located in Greenville, South Carolina, 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.  The South Carolina Department of Health and Environmental Control (state agency) performed a complaint investigation and recertification and extended survey on December 12 through 14, 2016.  The state agency surveyors concluded that Petitioner was not in substantial compliance with program participation requirements due to seven deficiencies that posed a risk for more than minimal harm.  The two allegations of noncompliance that allegedly posed immediate

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jeopardy and substandard quality of care began on June 10, 2016 and were corrected as of July 16, 2016, according to the surveyors and CMS.  The other noncompliance allegedly began on about December 12, 2016.  CMS Ex. 1; Jt. Stip. at 1-4; Request for Hearing (RFH) at 1-3.

CMS notified Petitioner by letter dated January 27, 2017, that it was imposing the following enforcement remedies:  mandatory termination of Petitioner’s provider agreement effective June 14, 2017, if Petitioner did not return to substantial compliance prior to that date; a CMP of $7,291 per day effective June 10 through July 15, 2016, and a CMP of $303 per day, effective December 12, 2016, and continuing until termination or Petitioner’s return to substantial compliance; and a discretionary denial of payment for new admissions (DPNA) effective February 11, 2017, if Petitioner did not return to substantial compliance before that date.  CMS also advised Petitioner that its approval to conduct a Nurse Aide Training and Competency Evaluation Program (NATCEP) may be affected as a result of its noncompliance, and that Petitioner would receive further notification from the state.  CMS Ex. 2 at 2-4; Jt. Stip. at 2. 

CMS notified Petitioner by letter dated March 30, 2017, that a revisit survey conducted on February 7, 2017, found that Petitioner returned to substantial compliance with program participation requirements effective January 10, 2017.  CMS advised Petitioner that the proposed DPNA and termination did not go into effect.  CMS Ex. 3; Jt. Stip. at 2‑3.

Petitioner requested a hearing before an administrative law judge (ALJ) on March 27, 2017.  On April 3, 2017, the case was assigned to me for hearing and decision, and an Acknowledgement and Prehearing Order was issued at my direction.  On October 25, 2018, Petitioner waived an oral hearing and the parties requested a decision on the documentary evidence and their filings.  On October 31, 2018, I accepted the waiver of oral hearing and set a briefing schedule.  On December 7, 2018, the parties filed briefs (CMS Br. and P. Br., respectively).  CMS and Petitioner filed reply briefs on January 3 and 4, 2019 (CMS Reply and P. Reply, respectively).  CMS offered CMS Exs. 1 through 18 and Petitioner offered Petitioner’s exhibits (P. Exs.) 1 through 3, which are admitted as evidence. 

II.  Discussion

A.  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 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.2  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 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.

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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, $6,291 per day to $20,628 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.3  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2016).  “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, $103 per day to $6,188 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2016).

Petitioner was notified in this case that it may be ineligible to conduct a NATCEP.  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $10,314; or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. § 483.13 (Resident Behavior and Facility Practices), § 483.15 (Quality of Life), or § 483.25 (Quality of Care) that are found to constitute either immediate jeopardy, a

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pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  In this case, the alleged substandard quality of care triggered an extended or partial extended survey, which triggered the ineligibility to conduct a NATCEP and is a basis for ALJ review.  42 C.F.R. §§ 483.151(b)(2)(iii); 498.3(b)(14)(ii), (16) (finding of substandard quality of care that results in loss of approval of NATCEP is an initial determination subject to review).  The CMP proposed by CMS also triggered ineligibility to be approved to conduct a NATCEP in this case.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination).  I conclude that in this case Petitioner became ineligible to be approved to conduct a NATCEP for two years by operation of law.  I have no authority to declare the ineligibility invalid.  Petitioner’s two-year period of ineligibility began on December 14, 2016 and ended on December 14, 2018.  42 C.F.R. § 483.151(b)(2).  Although the period of ineligibility has already expired, the ineligibility to conduct a NATCEP remains an issue as it triggers Petitioner’s right to request review of the scope and severity determinations and the determination of substandard quality of care that triggered the ineligibility to be approved to conduct a NATCEP.

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 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 situations where that finding was the basis for an immediate jeopardy determination, or, possibly, in the case of a finding of substandard quality of care caused the loss of approval of a NATCEP.  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).

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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.4  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 (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

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with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.”  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  Black’s Law Dictionary 1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing; that is, CMS should be burdened 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 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.

B.  Issues

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

Whether the declaration of immediate jeopardy was clearly erroneous, and 

Whether the remedies proposed are reasonable.

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making.5  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it

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

The complaint investigation and survey completed December 14, 2016, cited Petitioner for seven regulatory violations (deficiencies) that amounted to noncompliance because they allegedly posed a risk for more than minimal harm.  The regulations allegedly violated include:  42 C.F.R. § 483.10(b)(4) (Tag F155,6 scope and severity (s/s) D);7 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282, s/s J); 42 C.F.R. § 483.25(a)(3) (Tag F312, s/s D); 42 C.F.R. § 483.25(e)(2) (Tag F318, s/s E); 42 C.F.R. § 483.25(h) (Tag F323, s/s J), 42 C.F.R. § 483.35(i) (Tag F371, s/s E); and 42 C.F.R. § 483.75(o)(1) (Tag F520, s/s E).  CMS Ex. 1; Jt. Stip. at 3-4.

The surveyors allege noncompliance under Tag F155, based on Petitioner’s failure to comply with the requirements for creating an advance directive for Resident 101.  CMS Ex. 1 at 4-5.  Under Tag F282 the surveyors allege Petitioner failed to ensure services

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were provided by qualified personnel in accordance with Residents 67’s, 76’s, and 101’s written plans of care.  The surveyors allege that the noncompliance cited under Tag F282 posed immediate jeopardy for Resident 67, but not Residents 76 and 101.  CMS Ex. 1 at 6-10.  Under Tag F312, the surveyors allege noncompliance based on the facility’s failure to provide necessary services to maintain grooming for Resident 76.  CMS Ex. 1 at 10‑11.  Under Tag F318, Petitioner’s alleged noncompliance was its failure to ensure that Residents 76 and 101, who had limited range of motion, received appropriate treatment and services to increase range of motion and/or prevent further decrease in range of motion.  CMS Ex. 1 at 11-14.  The surveyors alleged noncompliance under Tag F323 that posed immediate jeopardy because the facility failed to ensure that Residents 67 and 78 received adequate supervision and assistance devices to prevent accidents.  CMS Ex. 1 at 14-24.  Under Tag F371, Petitioner is alleged to have had unsanitary conditions with a stove and ovens.  CMS Ex. 1 at 24-25.  Lastly, the surveyors alleged under Tag F520 that Petitioner’s quality assessment and assurance committee failed to implement, as of the survey, its August 2016 plan of action to ensure Residents 76 and 101 received their physician-ordered splints.  CMS Ex. 1 at 25-27. 

The surveyors determined that immediate jeopardy existed related to the examples of Residents 67 and 78 as of June 10, 2016 that was abated as of July 16, 2016, which was also the date Petitioner corrected the deficiencies and returned to substantial compliance.  CMS Ex. 1 at 1-2.  The surveyors determined that Petitioner was again noncompliant with program participation requirements, but not at the level of immediate jeopardy, beginning about December 12, 2016, and returned to substantial compliance effective January 10, 2017.  CMS Exs. 1, 3. 

In its request for hearing filed March 27, 2017, Petitioner specifically disputes that it was noncompliant as alleged by the investigation and survey completed on December 14, 2016.  RFH at 2-3.  Petitioner disputes the reasonableness of the CMP.  Petitioner also asserts that its loss of authority to conduct a NATCEP is not reasonable or proper.  RFH at 3.  However, as already noted the loss of NATCEP approval is not an enforcement remedy that the state agency or CMS have discretion to impose.  42 C.F.R. § 488.406 (list of enforcement remedies that the state or CMS may impose in addition to termination).  Ineligibility to conduct a NATCEP and the requirement to withdraw approval of an existing NATCEP is required by regulations under the conditions specified.  42 C.F.R. § 483.151(b)(2), (f).  However, the loss of eligibility or withdrawal of prior approval may trigger a right to request a hearing related to a finding of substandard quality of care that causes the loss of eligibility or approval.  42 C.F.R. § 498.3(b)(14)(ii), (16).  Further,  Petitioner asserts that even if it was noncompliant, CMS incorrectly identified the duration of the noncompliance.  RFH at 3-5. 

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

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CMS made a prima facie showing Petitioner violated 42 C.F.R. §§ 483.10(b)(4), 483.20(k)(3)(ii), 483.25(a)(3), 483.25(e)(2), 483.25(h), 483.35(i), and 483.75(o)(1) as alleged, and the violations posed a risk for more than minimal harm;

Petitioner has not rebutted the CMS prima facie showing 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 and the duration of immediate jeopardy is clearly erroneous for the violations of 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25(h); and

The proposed enforcement remedies are reasonable.   

The alleged noncompliance under Tags F323 and F282, which allegedly posed immediate jeopardy, are discussed under conclusions of law 1 and 2, respectively.  Tags F318, F520, F155, F312, and F371 are discussed under conclusions of law 3, 4, 5, 6, and 7, so that allegations related to specific residents are grouped together. 

1. Petitioner violated 42 C.F.R. § 483.25(h) (Tag F323) and the violation posed a risk for more than minimal harm.

a.  Facts

The surveyors alleged this noncompliance involved Resident 67 and Resident 78.

(i)  Resident 67

Resident 67, a female, was just a few days from her 88th birthday when it was observed by Petitioner’s staff that she had a large discoloration of her left inner thigh and complaints of pain with movement.  She was sent to the emergency room and x-rays showed that she had a femur fracture of undetermined age.  The discovery of the fracture was reported to the state agency.  CMS Ex. 5 at 2, 4-5, 13-17.  Petitioner sent the state agency a five-day follow-up report on June 16, 2016, in which it listed diagnoses for Resident 6 including muscle weakness, lack of coordination, vitamin deficiency; and risks for falling, bruising, bleeding, and skin tears.  Resident 67 was reported to be totally dependent on staff for all activities of daily living (ADLs), she was immobile, and deaf.  She had a history of a left hip fracture with placement of a steel rod.  She was also reported to be combative with staff when they were delivering ADL care.  CMS Ex. 5 at 4.  Petitioner stated in its five-day report that an orthopedist opined that the fracture may have occurred during a transfer.  Petitioner stated in its report that a certified nurse assistant (CNA) was disciplined for failure to use a lift, apparently to transfer Resident

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67.  Petitioner also advised the state agency that staff was trained to check resident requirements for transfers prior to giving care.  CMS Ex. 5 at 5.  An interview summary worksheet dated June 10, 2016, provided with the five-day report states that CNA DS admitted that on June 10, 2016, he transferred Resident 67 twice by himself without a lift.  The summary states CNA DS did not know he was not to transfer the resident without a lift and that he claimed he had not been trained to understand the icons posted above the resident’s bed indicating use of a lift was required for transfers.  CMS Ex. 5 at 8.  Petitioner also provided the summary of an interview with the resident’s orthopedist who stated that the fracture occurred just below the rod in her left femur; the fracture may have occurred during a transfer when her left foot landed on the floor; given the resident’s brittle bones not much would be required to cause a fracture; and he believed the impact was not forceful but was likely very subtle so that even an attentive person may not have known.  CMS Ex. 5 at 12.

Surveyor Sean Carr provided a declaration, which was admitted as CMS Ex. 17.  Surveyor Carr did the investigation related to Resident 67.  Surveyor Carr found that Petitioner had determined that the use of a Hoyer™ lift was required to safely transfer Resident 67.  However, the surveyor found that Resident 67 was transferred twice on June 10, 2016 by a CNA without using a Hoyer™ lift, which risked injury of the resident.  CMS Ex. 17 at 1-2.

Petitioner does not deny that Resident 67 suffered an impact fracture of her left femur.  According to her orthopedist the facture may have occurred during a manual stand and pivot transfer by a CNA.  Petitioner’s medical director concurred with the orthopedist’s opinion but also stated as an “educated guess” that the fracture may have occurred due to the resident’s kicking.  P. Br. at 3-4.  While the actual cause of the femur fracture may be subject to some dispute, the fact the resident was transferred twice by a CNA without using the Hoyer™ lift as required by the resident’s care plan is not disputed. 

There is no dispute that Petitioner took corrective action and ended the noncompliance related to Resident 67 as of July 16, 2016.  CMS Ex. 1 at 2, 8.

(ii)  Resident 78 

Petitioner does not dispute that Resident 78 was left outside unattended on July 12, 2016.  P. Br. at 4.  Petitioner admits that its investigation showed that the resident was taken to the courtyard by the contracted speech therapist.  The therapist reported she told two nursing staff members that the resident was in the courtyard but there was no plan to bring the resident back inside the facility.  The two nursing staff members were terminated.  The contracted speech therapist did not return to the facility to work after the incident.  P. Br. at 4-5; P. Ex. 3 at 2.

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Petitioner does not dispute the allegations of the SOD that due to being left in the courtyard unattended, Resident 78 suffered burns to both shoulders and hyperthermia.  Resident 78 had no way to summon assistance, to propel his wheelchair, or to open the door to return inside the facility.  CMS Ex. 1 at 15, 20-21; P. Br.; P. Reply.

Surveyor Carolyn Rice provided a declaration admitted as CMS Ex. 16.  She states in her declaration that she made the findings in the SOD regarding Resident 78.  Surveyor Rice states she found staff left Resident 78 outside for about three hours with no supervision.  Resident 78 was incapable of returning inside the facility, he had no means of hydration, and it was hot.  When he was discovered his temperature was 106 degrees (I infer Fahrenheit) and he was lethargic and unresponsive.  He was transported to the hospital and diagnosed with hyperthermia and dehydration.  CMS Ex. 16.  Petitioner does not rebut the declaration of Surveyor Rice.

There is no dispute that the noncompliance related to Resident 78 was corrected as of July 16, 2016.8

b.  Analysis

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.25(h) (Tag F323) with respect to Resident 67 and Resident 78 and the violations posed immediate jeopardy.  CMS Ex. 1 at 14-24. 

Pursuant to 42 C.F.R. § 483.25, which establishes quality of care participation requirements, a facility is obliged to ensure that the facility provides and each resident receives “the necessary care and services to attain or maintain the [resident’s] highest practicable physical, mental, and psychosocial well-being, in accordance with the [resident’s] comprehensive assessment and plan of care.”  Regarding the prevention or avoidance of accidents, the regulation requires: 

(h) Accidents.  The facility must ensure that—

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

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

42 C.F.R. § 483.25(h).  The surveyors allege that Resident 67 was transferred incorrectly contrary to her care plan because she was transferred by a single staff member rather than two and without the use of a Hoyer™ lift.  The surveyors allege that Resident 78 was left unsupervised outside with resulting hyperthermia, dehydration, and sunburn on both shoulders.  CMS Ex. 1 at 15.  Therefore, the SOD alleges violations of 42 C.F.R. § 483.25(h)(2) based on Petitioner’s failure to ensure Residents 67 and 78 received adequate supervision and assistance devices to prevent accidents. 

The Board has previously stated that 42 C.F.R. § 483.25(h) does not make a facility strictly liable for accidents that occur, but that the regulation does require that a facility take all reasonable steps to ensure that:  (1) a resident receives supervision and assistance devices that meet his or her assessed needs; and (2) mitigate foreseeable risks of harm from accidents.  Woodstock Care Ctr., DAB No. 1726 at 28-30.  A facility is permitted the flexibility to choose the methods of supervision it uses to prevent accidents, but the chosen methods must be adequate under the circumstances.  Whether supervision is “adequate” depends in part upon a resident’s ability to protect him or herself from harm.  Id.  Based on the regulation and the cases in this area, CMS meets its burden to make a prima facie case if the evidence demonstrates that the facility failed to provide adequate supervision and assistance devices to prevent accidents, given what was reasonably foreseeable.  Alden Town Manor Rehab. & HCC, DAB No. 2054 at 5-12 (2006).  An “accident” is an unexpected, unintended event that can result in injury of a resident.  It does not include adverse outcomes that are a direct consequence of treatment or care provided in accordance with current standards of practice (e.g., drug side effects or reactions).  Woodstock Care Ctr., DAB No. 1726 at 4. 

In Good Shepherd, DAB No. 2858, an appellate panel of the Board discussed its prior interpretations and applications of 42 C.F.R. § 483.25(h)(2) in detail.  The case involved a 38-year-old resident (Resident 19, in that case) with a poor prognosis who required a wheelchair for mobility.  He was frequently noncompliant with treatment.  An occupational therapist approved the resident for use of a motorized wheelchair within the facility and to go outside to smoke unsupervised.  Good Shepherd’s policy regarding the use of motorized wheelchairs required the occupational therapist’s evaluation prior to allowing a resident to have and operate such a wheelchair.  The occupational therapist specified that the resident was to go nowhere else outside without supervision.  She testified that she included the requirement for supervision when operating the wheelchair outside, except to smoke, because she did not actually evaluate the resident’s ability to use the motorized wheelchair in areas other than the smoking area or off facility grounds.  The resident’s comprehensive care plan was not updated to reflect his use of the motorized wheelchair or the restriction imposed by the occupational therapist.  The problem arose because the resident would use his motorized wheelchair to leave the

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facility grounds without supervision.  Staff, including the medical director and director of nursing, was aware of the resident’s activities.  On the first day of the survey, a surveyor saw the resident riding his wheelchair, unsupervised, down the street talking on his cell phone, which the surveyor concluded was unsafe.  Id. at 3-5.  The resident’s treating physician, who was also Petitioner’s medical director, testified at the hearing that the resident was alert and oriented, able to use his hands, able to make his own decisions, capable of taking care of himself, and, in the physician’s opinion, did not need to be supervised while off Petitioner’s property.  Id. at 9.  The Board reversed the ALJ’s decision that Petitioner had shown that it reasonably balanced the need to ensure the resident was as safe as possible with the resident’s rights to dignity and self‑determination when not preventing the resident from departing facility grounds in his motorized wheelchair without supervision.  Id. at 1.

The Board in Good Shepherd discussed its prior conclusions regarding the application of 42 C.F.R. § 483.25(h)(2) which are summarized as follows (omitting multiple citations to prior Board decisions):

Section 483.25(h)(2) ‘obligates the facility to provide supervision and assistance devices designed to meet the resident’s assessed needs and to mitigate foreseeable risks of harm from accidents’ and to ‘provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree consistent with accepted standards of nursing practice.

[I]n order to comply with section 483.25(h)(2), a SNF must identify and assess foreseeable accident risks; determine what, if any, interventions are necessary and appropriate to mitigate the assessed risk; and take timely and effective steps to implement the chosen interventions.

[S]ection 483.25 obligate[s] the SNF to furnish the care and services set forth in a resident’s care plan, to implement doctor’s orders, to monitor and document the resident’s condition, and . . . to follow its own resident care policies. . . .  [F]ailure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard. 

[A] SNF violates section 483.25(h)(2) if it fails, without ‘justifiable reason,’ to implement accident precautions that its own staff has determined to be necessary to mitigate foreseeable accident risks.

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Id. at 11-14.  The Board held that Resident 19’s records revealed no justifiable reason for nursing staff not to supervise Resident 19 when he left facility property in his motorized wheelchair.  The Board reasoned that the occupational therapist issued recommendations in accordance with the facility care policy, which had the purpose of preventing accidents involving motorized wheelchairs.  However, Petitioner failed to explain why it failed to follow the occupational therapist’s recommendation which, the Board held, violated the obligation to provide adequate supervision.  The Board found that the opinions of the resident’s physician and the position of the facility that the resident was alert and oriented and could make his own decisions were immaterial and largely irrelevant.  Id. at 15.  The Board stated that under Petitioner’s policy it was the occupational therapist who was responsible for assessing the resident’s safety needs not the resident’s physician.  The resident’s physician was also the medical director for the facility and the Board stated he was required to follow the occupational therapist’s assessment, unless it was revisited and changed.  According to the Board, so long as the care plan established by the occupational therapist was in place, “under the facility’s policies, federal regulations, and [Board decisions], staff were required to supervise Resident 19 when he used his wheelchair off facility grounds.”  Id. at 17.  The Board rejected the notion that a resident’s right to be independent, including the right to refuse treatment, excused Petitioner’s failure to follow its policy and the occupational therapist’s assessment, stating that what is required is for the facility to address balancing restrictions on resident rights against the need for protecting the resident from accidents, presumably in writing and contemporaneously.  Id. at 18-19.  The Board stated that the issue was “not whether supervising [the resident’s] motorized wheelchair use would have unduly restricted his autonomy or freedom of movement, but whether [the facility met its obligation under section 483.25(h)(2)] to provide [the resident] with the supervision that its own staff thought necessary to prevent accidents.”  Id. at 21. 

In Good Shepard, CMS did not present evidence that there was a foreseeable accident hazard other than the surveyor’s expressed concern, clearly showing that the mere allegation of a foreseeable accident hazard is acceptable to the Board.  Furthermore, the Board clearly recognized that the occupational therapist did not actually assess for accident hazards associated with the resident leaving facility grounds unsupervised but imposed the restriction because she did not do the assessment.  Nevertheless, the Board concluded that Petitioner was bound to comply with the occupational therapist’s limitations imposed on the resident because Petitioner’s policy required the assessment by the therapist before providing a resident a motorized wheelchair.  Even though the resident’s primary care physician believed that the restriction was unnecessary, the Board refused to accept his testimony as sufficient evidence that there was no foreseeable risk of accidental injury of the resident or that the resident’s rights trumped Petitioner’s policy and the therapist’s non-assessment that supervision was necessary if the resident left facility grounds.  The Board is clear that once the occupational therapist imposed the restriction, which the resident repeatedly violated, the resident’s care planning team

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should have met to assess potential accident hazards, developed necessary interventions to reduce the risk for harm to the resident, and the assessment and care planning should have been reduced to writing. 

It is necessary to apply the regulatory participation requirement as interpreted by the Board to the examples of Residents 67 and 78.  I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(h)(2) and the violation posed a risk for more than minimal harm with respect to Resident 67, which Petitioner has not rebutted.  Petitioner does not dispute that Resident 67 was assessed as requiring the use of a Hoyer™ lift and two people for transfers.  Petitioner does not dispute that Resident 67’s care plan required the use of a Hoyer™ lift and two staff members for her transfer.  The assessment is evidence that Petitioner foresaw a risk for accidental injury if the care planned interventions were not used.  The CNA violated the care planned interventions.  Therefore, Petitioner failed to ensure that Resident 67 received the supervision and assistance the resident’s interdisciplinary team determined adequate and necessary to avoid accidental injury.  

Petitioner does not deny the occurrence of the incident involving Resident 67.  Rather, Petitioner argues that the noncompliance existed from June 10 through June 15, 2016.  Petitioner argues that it timely self-reported the incident to the state agency and that it immediately implemented a plan of correction, which involved staff training.  Petitioner argues that the plan of correction was completed by June 15, 2016, with no further correction required by the surveyors who, nevertheless, concluded that immediate jeopardy was not corrected until July 16, 2016.  Petitioner argues that the incident involving Resident 67 was past noncompliance.  P. Br. at 4; P. Reply at 2, 4; P. Ex. 3 at 1.  Petitioner argues that the period of past noncompliance related to the incident involving Resident 67 should be found to be only June 10 through June 15, 2016, a period of only six days.  P. Br. at 8.9  However, the evidence does not support Petitioner’s theory. 

The surveyors allege in the SOD that the immediate jeopardy citations were corrected as of July 16, 2016.  CMS Ex. 1 at 4, 9, 15, 24.  The surveyors specifically found that the immediate jeopardy related to the example of Resident 67 was corrected as of July 16, 2016.  CMS Ex. 1 at 8.  The surveyors listed various corrective actions undertaken by Petitioner.  The surveyors specifically noted that education was completed on July 14, 2016, related to resident abuse/neglect, including the interpretations of icons above resident beds to determine care plan requirements.  The surveyors noted that after July 14, 2016, education was completed for staff members as they arrived for their next shift.

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The surveyors further stated that Petitioner’s quality assurance team met on July 13, 2016 and adopted a plan for a three-month period of monitoring.  CMS Ex. 1 at 2-3, 8-9, 22‑24.

Petitioner offered as evidence without objection the declaration of Evelyn Harris, Petitioner’s director of nursing (DON).  DON Harris testified that following the June 10, 2016 incident involving Resident 67, the incident was reported to the state agency, which is consistent with the evidence (CMS Ex. 5).  DON Harris further testified that a plan of correction was implemented, and the last corrective action, staff in-service training, was completed on June 15, 2016.  She states that the state surveyors required no further corrective action related to the incident involving Resident 67.  P. Ex. 3.  DON Harris does not specifically deny the surveyors’ allegations that Petitioner provided further training for staff regarding understanding care plan requirements for residents that continued through July 14, 2016.  DON Harris also does not deny the surveyors’ allegation that a quality assurance monitoring plan was not adopted until on about July 13, 2016.  

CMS responds to Petitioner’s argument pointing out that Petitioner’s own evidence (P. Ex. 1) does not show that CNA DS who transferred Resident 67 twice without a Hoyer™ lift actually attended the in-service training in June 2016, which was part of Petitioner’s plan of correction related to the incident involving Resident 67.  CMS Reply at 3.  My review of P. Ex. 1, Petitioner’s record of in-service training dated June 13 through 15, 2016, is consistent with the CMS assertion as the name of CNA DS is not listed as having attended training.

Petitioner is correct that the issue of when a facility returns to substantial compliance is subject to de novo review by an ALJ and on appeal to the Board.  De novo review extends to reviewing whether a facility was in substantial compliance during a period between two periods of noncompliance so long as the facility was on notice that its compliance status was in issue during the period.  Foxwood Springs Living Ctr., DAB No. 2294 at 12-13 (2009).  Petitioner’s defense is that it returned to substantial compliance between the incident involving Resident 67 and Resident 78, thereby reducing the period of alleged noncompliance that may be a basis for imposition of a CMP.  P. Br. at 6-8; P. Reply at 4.  Therefore, in this case, Petitioner clearly is on notice that its compliance status during the period following June 15, 2016, was in issue as Petitioner raised the issue. 

Immediate jeopardy is abated “only when the facility has implemented necessary corrective measures so that there is no longer any likelihood of serious harm.”  Life Care Ctr. of Bardstown, DAB No. 2479 at 35 (2012) (citing Pinehurst Healthcare & Rehab. Ctr., DAB No. 2246 at 15 (2009).  Also, in Fairfax Nursing Home, Inc., DAB No. 1794 at 13-14 (2001), the Board stated that “a finding of immediate jeopardy is not contingent on a finding that each individual incident placed a resident at such a degree of potential or

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risk of serious harm that there was a likelihood of harm to that specific resident at that particular time . . . .  Findings about incidents related to individual residents are not themselves the deficiencies that must be corrected – the deficiency is the underlying failure to meet a participation requirement evidenced by the incident.” Aff’d, Fairfax Nursing Home v. Dep’t of Health & Human Servs., 300 F.3d 835 (7th Cir. 2002), cert. denied, 537 U.S. 1111 (2003).  The burden is on the facility to show that it proposed an acceptable plan of correction and fully implemented it, and “[i]t is not enough that some steps have been taken, but rather the facility must prove that the goal has been accomplished.”  Lake Mary Health Care, DAB No. 2081 at 29 (2007).

I conclude based on my review of the evidence that Petitioner has not shown by a preponderance of the evidence that it completed its corrective actions to return to substantial compliance prior to July 16, 2016.  Contrary to DON Harris’ testimony, the evidence does not show that all staff received in-service training, which she asserts was the last corrective action, by June 15, 2016.  Petitioner does not deny that CNA DS is not listed as having been trained in June 2016.  The surveyors also found, and Petitioner does not dispute, that Petitioner’s quality assurance team did not adopt a monitoring plan until July 13, 2016.  The surveyors also found, and Petitioner has not disputed, that on July 14, 2016 and after, Petitioner was re-educating staff on resident abuse/neglect, including how to interpret icons above resident beds reflecting care plan requirements.  Petitioner admits that its training in July 2016 also covered all types of abuse and neglect.  P. Reply at 5.  While Petitioner asserts the accidents involving the residents were different, that fact does not rebut the surveyors’ findings that correction of the noncompliance was not completed before July 16, 2016.

I also conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(h)(2) and the violation posed a risk for more than minimal harm with respect to Resident 78.  Petitioner has not rebutted the CMS prima facie showing of noncompliance related to the incident involving Resident 78.  The evidence shows that Petitioner’s staff left Resident 78 unsupervised and unattended in the facility courtyard for about three hours on a hot day.  Resident 78 was unable to propel his wheelchair so that he could return inside the facility.  Assistance and supervision for Resident 78 was clearly foreseeably necessary under the circumstances, and no assessment or care plan has been placed in evidence providing for either assistance or supervision under the circumstances.  As a result, Resident 78 suffered actual harm of a sunburn on his shoulders, hyperthermia, and dehydration.

Petitioner does not deny the factual allegations regarding Resident 78 or that those facts establish noncompliance under Tag F323.  Petitioner argues that it timely self-reported the incident to the state agency, conducted an investigation, immediately implemented a plan of correction including staff training, and that the incident was past noncompliance.  P. Br. at 4-5; P. Reply at 2-4.  Petitioner asserts that it achieved substantial compliance with respect to the incident involving Resident 78 on July 16, 2016, upon completion of

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its plan of correction.  P. Ex. 7-8.  The surveyors determined that Petitioner corrected the noncompliance related to both Residents 67 and 78 as of July 16, 2016.  Therefore, Petitioner does not dispute that it was not in substantial compliance, at least related to the example of Resident 78, before July 16, 2016.  Petitioner does not dispute that Resident 78 was treated for sunburn, hyperthermia, and dehydration or that those conditions constitute actual harm.  CMS cited Petitioner’s violation of 42 C.F.R. § 483.25(h)(2) as constituting immediate jeopardy.  As discussed hereafter, Petitioner has failed to meet its burden to show that the immediate jeopardy declaration was clearly erroneous.

2.  Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282) with respect to Resident 67, 76, and 101 and the violation posed a risk for more than minimal harm.

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282) with respect to Resident 67, and the violation posed immediate jeopardy.  CMS Ex. 1 at 1, 6-9.  The surveyors also allege that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) at the non-immediate jeopardy level with respect to two other residents, Resident 76 and Resident 101.  CMS Ex. 1 at 9-10. 

The regulation at 42 C.F.R. § 483.20(k)(3)(ii) requires that “[t]he services provided or arranged by the facility must . . . [b]e provided by qualified persons in accordance with each resident’s written plan of care.”  A facility violates 42 C.F.R. § § 483.20(k)(3)(ii) if its staff fails to carry-out the instructions of the care plan, even if, facility staff are qualified to provide the services called for by the plan of care.  Oaks of Mid City Nursing & Rehab. Ctr., DAB No. 2375 at 18 (2011); Woodland Oaks Healthcare Facility, DAB No. 2355 at 15 (2010).

The facts related to the incident involving Resident 67 discussed under Tag F323, are the same facts cited by the surveyors as the basis for citing noncompliance under Tag F282.  There is no dispute that Resident 67’s care plan required the use of a Hoyer™ lift and a two-person assist for all transfers.  On June 10, 2016, Petitioner’s CNA DS transferred Resident 67 on two occasions, and both times, the CNA failed to use a Hoyer™ lift and failed to obtain the assistance of another staff member.  Petitioner does not deny that CNA DS failed to follow Resident 67’s care plan by not using a Hoyer™ lift and another staff member to transfer the resident.  In its defense, Petitioner points out that it implemented corrective actions, including staff training.  I find that the record establishes that Petitioner failed to provide Resident 67 with services in accordance with her written plan of care.  Accordingly, I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) with respect to Resident 67 and that the violation posed a risk for more than minimal harm.  The surveyors allege that the noncompliance based on the incident involving Resident 67 was not corrected until July 16, 2016.  CMS Ex. 1 at 8-9.  Petitioner’s arguments that it returned to substantial compliance with respect to the noncompliance involving Resident 67 are rejected for the

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reasons discussed under Tag F323.  I conclude that Petitioner failed to rebut CMS’s prima facie showing.  I also conclude as discussed hereafter that Petitioner failed to meet its burden to show that the declaration of immediate jeopardy was clearly erroneous.

In addition to Resident 67, the surveyors also allege in the SOD that Petitioner was non‑compliant with 42 C.F.R. § 483.20(k)(3)(ii) with respect to Resident 76 and Resident 101, but not at the scope and severity of immediate jeopardy.  The surveyors allege that, for Resident 76 and Resident 101, Petitioner failed to provide them with splints as required by their care plans.  CMS Ex. 1 at 9-10.

According to the SOD, Resident 76’s diagnoses included hand contractures, dementia, and depression.  The SOD alleges that Resident 76 had a physician’s order dated October 22, 2015, for restorative nursing to provide range of motion therapy and for elbow and hand/wrist splints.  Resident 76’s care plan dated November 9, 2016, indicated that the resident was to receive passive range of motion and that splints were to be applied as ordered.  However, Petitioner failed to provide any of the required splints to Resident 76.  The surveyor observed on multiple occasions that the resident had no splints in place.  Further, during the survey staff reported to the surveyor that the elbow splint had not been ordered.  CMS Ex. 1 at 10, 14; CMS Ex. 7 at 5; CMS Ex. 18 at 1.  In a surveyor interview, Petitioner’s nurse confirmed that Resident 76 was care-planned for a wrist splint and admitted that there was no documentation to indicate that the splint was being provided.  CMS Ex. 1 at 10

Resident 101’s diagnoses included contractures of both hands and dementia.  According to the SOD, Resident 101 had a physician’s order dated October 16, 2016, stating that bilateral hand carrots were to be discontinued due to misplacement.  New splints were received on October 26, 2016.  CMS Ex. 1 at 9, 12.  Resident 101’s care plan, updated on November 17, 2016, indicated “hand carrots as ordered.”  The surveyor observed on multiple occasions that the resident had no hand splints in place.  CMS Ex. 1 at 9, 12; CMS Ex. 18 at 1.  In an interview, Petitioner’s nurse stated that Resident 101 needed hand splints and confirmed that the splints were not in place as required by the resident’s care plan.  CMS Ex. 1 at 9, 12-13.

Surveyor Jessie M. Dickerson testified by declaration that she wrote the findings regarding Residents 76 and 101 under Tags F155, F282, F312, F318, and F520 and opined that there was a risk for more than minimal harm as failure to apply splints as ordered risked worsening of contractures further limiting the residents’ abilities to perform ADLs.  CMS Ex. 18 at 1. 

Surveyor Rice explained that the purpose of a splint is preventing contractures, preventing further decrease in the range of motion, and preserving a resident’s ability to engage in ADLs.  Surveyor Rice noted further that, as long as a resident with hand contractures is able to keep the hand open, the resident can engage in therapy, which may

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either halt or at least slow down the decline in the range of motion.  She opined that failure to provide residents with splints as ordered poses a risk for more than minimal harm.  CMS Ex. 16 at 1-2.  Petitioner presented no evidence to rebut the surveyors’ opinions. 

Petitioner stated in its hearing request that it “disagrees” with this citation.  In its prehearing brief, Petitioner stated it did not concede any of the allegations of noncompliance or related enforcement remedies.  Petitioner advised me that it would focus its briefs on the past noncompliance alleged under Tags F282 and F323 and the CMP imposed based on that noncompliance.  P. Br. at 8.  Therefore, I conclude that Petitioner did not waive its right to review as to any of the Tags alleged in the SOD or the enforcement remedies imposed.  However, Petitioner did not present any evidence to rebut the allegations of the surveyors in the SOD or the testimony of either Surveyor Rice or Surveyor Dickerson.  Petitioner’s own staff told the surveyor that splints were not provided for Resident 76 and Resident 101 as required by their care plans. 

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.10(k)(3)(ii) with respect to Resident 76 and Resident 101, which Petitioner has not rebutted.  I find further that the violation posed a risk for more than minimal harm without actual harm or immediate jeopardy.

3.  Petitioner violated 42 C.F.R. § 483.25(e)(2) (Tag F318) based on the examples of Residents 76 and 101 and the violation posed a risk for more than minimal harm.

A facility must ensure that ‘[a] resident with a limited range of motion receives appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion.”  42 C.F.R. § 483.25(e)(2).  In alleging that Petitioner violated 42 C.F.R. § 483.25(e)(2) (Tag F318), the surveyors rely on the same facts related to Resident 76 and Resident 101 that were cited under Tag F282.  CMS Ex. 1 at 12-14. 

The surveyors allege in the example of Resident 101 that Petitioner ordered new hand splints that arrived October 26, 2016.  However, as of the December 2016 survey, the surveyors observed that Resident 101 had not been provided with the splints as required by her care plan.  CMS Ex. 1 at 12-13; CMS Ex. 7 at 7.  The surveyors record in the SOD that an interview with Petitioner’s occupational therapist indicated that there was no assessment of Resident 101 for use of hand splints.  The surveyors also record that a nurse stated during an interview that Resident 101 was to have rolled washcloths in her hands, I infer to help maintain her range of motion of her hands.  However, no washcloths were observed to be in use.  CMS Ex. 1 at 12-13; CMS Ex. 7 at 7.

Petitioner stated in its hearing request that it “disagrees” with the citation of noncompliance.  However, Petitioner offered no evidence to rebut the surveyors’

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observations or to rebut the statements of its own staff.  Petitioner did not specifically address this alleged noncompliance in briefing.

I have already found that Petitioner violated 42 C.F.R. § 483.20(k)(3)(ii) (Tag F282) based on its failure to provide hand splints to Resident 76 and Resident 101 as required by their care plans.  I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(e)(2), which Petitioner has not rebutted.  I also conclude that Petitioner’s noncompliance posed a risk for more than minimal harm without actual harm or immediate jeopardy.

4.  Petitioner violated 42 C.F.R. § 483.75(o)(1) (Tag F520) and the violation posed a risk for more than minimal harm.

A SNF must have a quality assessment and assurance committee comprised of the DON, a facility-designated physician, and at least three other staff members.  The committee must meet at least quarterly to identify issues concerning quality assessment and assurance and develop and implement appropriate plans of action to correct identified quality assurance deficiencies.  42 C.F.R. § 483.75(o)(1), (2).

Surveyor Dickerson cited the noncompliance under Tags F282 and F318 as the bases for Petitioner’s noncompliance under Tag F520.  Surveyor Dickerson alleged that Petitioner’s quality assessment committee failed to ensure implementation of a plan of action adopted August 29, 2016, that was intended to address issues with residents needing restorative and other therapy services.  More specifically, the surveyor found Residents 76 and 101 did not have splints in use that had been ordered by their physicians and no documentation that either resident received restorative or other therapy related to the ordered splints.  Surveyor Dickerson recorded in the SOD that she was told by Petitioner’s administrator and nurse consultant that the plan of action had been adopted.  The surveyor noted that the plan of action did not address ensuring splints would be provided as ordered and there was no provision for monitoring and documenting follow‑up to ensure splints were provided and used as ordered.  Surveyor Dickerson was also told by the administrator that Petitioner’s director of therapy and care plan coordinator were supposed to monitor to ensure therapy and restorative services were provided but there was no provision for monitoring their performance.  Surveyor Dickerson was also told by the care plan coordinator that there was a lack of communication between rehabilitation and the quality assurance committee.  CMS Ex. 1 at 26-27; CMS Ex. 18.

Petitioner stated in its hearing request that it “disagrees” with this citation but presented no evidence to rebut the surveyors’ findings.  Petitioner did not address this alleged noncompliance in briefing.

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The evidence shows that Petitioner’s quality assurance team developed a plan of action on August 29, 2016.  However, the evidence also shows that Residents 76 and 101 did not receive physician order splints.  Resident 101’s new splints were received on about October 26, 2016.  However, as of the December 2016 survey, the surveyors observed that Resident 101 had no splints in place.  CMS Ex. 1 at 12-13; CMS Ex. 7 at 7; CMS Ex. 18 at 1.
The evidence shows that Petitioner failed to provide ordered splints for Residents 76 and 101, and as opined by Surveyor Dickerson, this fact plainly demonstrates the ineffectiveness of Petitioner’s quality assurance efforts.  CMS Ex. 18 at 2. 

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.75(o)(1) that Petitioner has not rebutted.  I also conclude that the violation posed a risk for more than minimal harm without actual harm or immediate jeopardy as alleged by the surveyors.

5.  Petitioner violated 42 C.F.R. § 483.10(b)(4) (Tag F155) in the example of Resident 101 and the violation posed a risk for more than minimal harm.

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.10(b)(4).  The regulation provides that a resident has the right to refuse treatment, to refuse to participate in experimental research, and to formulate an advance directive.  42 C.F.R. § 483.10(b)(4). 

The surveyors found in Petitioner’s records for Resident 101 that one physician had certified that Resident 101 was unable to make health care decisions.  Nevertheless, Petitioner’s record for Resident 101 showed that he or someone else had given the advance directive that he not be resuscitated (DNR).  The surveyors state in the SOD that they found in Resident 101’s record a physician order and a care plan for the DNR advance directive.  There seems to be no dispute that Resident 101 did not have the capacity to make the DNR election.  I infer based on the SOD that Petitioner had Resident 101 listed as a DNR based on the physician order.  The problem identified by the surveyors is that the resident’s record contained only one statement signed by a physician that the resident did not have the capacity to make health care decisions.  In order for the DNR election to have been made on the resident’s behalf, absent a court ordered guardianship, at least two physicians needed to certify Resident 101 could not make the election himself.  CMS Ex. 1 at 4-5.

The requirement for certification by two physicians is not found in 42 C.F.R. § 483.10(b)(4).  However, 42 C.F.R. § 483.10(a)(4) provides that any legal surrogate designated in accordance with state law may exercise the rights of a resident who has not been adjudged incompetent by a state court, to the extent provided by state law.

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South Carolina law requires that two licensed physicians who have examined a resident certify that the resident is unable to make health care decisions: 

(8) “Unable to consent” means unable to appreciate the nature and implications of the patient’s condition and proposed health care, to make a reasoned decision concerning the proposed health care, or to communicate that decision in an unambiguous manner.  This term does not apply to minors, and this chapter does not affect the delivery of health care to minors unless they are married or have been determined judicially to be emancipated.  A patient’s inability to consent must be certified by two licensed physicians, each of whom has examined the patient.  However, in an emergency the patient’s inability to consent may be certified by a health care professional responsible for the care of the patient if the health care professional states in writing in the patient’s record that the delay occasioned by obtaining certification from two licensed physicians would be detrimental to the patient’s health.  A certifying physician or other health care professional shall give an opinion regarding the cause and nature of the inability to consent, its extent, and its probable duration.  If a patient unable to consent is being admitted to hospice care pursuant to a physician certification of a terminal illness required by Medicare, that certification meets the certification requirements of this item.

S.C. Code Ann. § 44-66-20(8) (1990).  Petitioner has not alleged that the emergency provision is applicable in this case or presented any evidence in that regard.  The state statute clearly required that two licensed physicians certify that Resident 101 was unable to consent to the DNR before the resident’s surrogate, whether a family member, a physician, or someone else, could make that advance directive in his stead. 

Accordingly, I conclude that the failure to ensure two physicians certified that Resident 101 was unable to exercise the right to direct DNR status was a violation of the regulation and posed the risk for more than minimal harm if the election was honored without compliance with the protection provided by state law. 

Although Petitioner stated in its hearing request that it “disagrees” with this deficiency, it offered no evidence to rebut the surveyors’ observation and did not address this noncompliance in briefing.

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Accordingly, I conclude that Petitioner violated of 42 C.F.R. § 483.10(b)(4), and the violation posed a risk for more than minimal harm without actual harm or immediate jeopardy.

6.  Petitioner violated 42 C.F.R. § 483.25(a)(3) (Tag F312) and the violation posed a risk for more than minimal harm.

Petitioner must ensure that it provides and each resident receives necessary care and services in accordance with the resident’s comprehensive assessment and plan of care.  42 C.F.R. § 483.25.  One of the specific quality of care requirements under 42 C.F.R. § 483.25(a)(3) is the requirement for Petitioner to ensure that “[a] resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.”  42 C.F.R. § 483.25(a)(3). 

Surveyor Dickerson recorded her observations of Resident 76 in the SOD.  She observed that Resident 76 had long fingernails and a dark substance under his fingernails, and hair growing out of his ears.   She found no evidence in Resident 76’s record indicating that he refused fingernail or ear care.  CMS Ex. 1 at 11; CMS Ex. 18 at 2.  Surveyor Dickerson opined in her declaration that there was a risk for more than minimal harm as the resident’s long, dirty nails posed the risk the resident could scratch himself with a resulting infection and the failure to trim ear hair posed the risk that ear problems would not be detected.  CMS Ex. 18 at 2. 

Petitioner stated in its hearing request that it “disagrees” with this citation.  However, Petitioner offered no evidence to rebut the observations of the surveyor related to Resident 76. 

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.25(a)(3).  Further, Petitioner’s failure to care for Resident 76 implicated more than just dignity and grooming issues; his long, dirty fingernails put him at risk for skin tears and possible infection, and the neglect of his ears meant that if he had any ear-related problems, staff may not be aware of them.  I thus conclude that Petitioner’s violation of 42 C.F.R. § 483.25(a)(3) posed a risk for more than minimal harm without actual harm or immediate jeopardy.

7.  Petitioner violated 42 C.F.R. § 483.35(i) (Tag F371) and the violation posed a risk for more than minimal harm.

Pursuant to 42 C.F.R. § 483.35(i), a facility must “[s]tore, prepare, distribute, and serve food under sanitary conditions.”  The surveyors recorded in the SOD their observation that when inspecting Petitioner’s kitchen, they found unsanitary conditions, specifically, caked-on areas of dark brown debris on a stove back splash and inside the ovens.  When

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the surveyors pointed out these conditions to the dietary manager, she confirmed the observations.  CMS Ex. 1 at 24-25.

Petitioner stated in its hearing request that it disagreed with this allegation of noncompliance.  However, Petitioner offered no evidence to rebut the surveyors’ observations and did not specifically address this noncompliance in briefing. 

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.35(i), which Petitioner has not rebutted.  I also conclude that the violation posed a risk for more than minimal harm without actual harm or immediate jeopardy as alleged by the surveyors. 

8.  Petitioner has not met its burden to show that the declaration of immediate jeopardy from June 10 through July 15, 2016 due to the noncompliance under 42 C.F.R. §§ 483.20(k)(3)(ii) (Tag F282) and 483.25(h) (Tag F323), was clearly erroneous.  

The surveyors alleged in the SOD and CMS argues before me that the noncompliance under Tags F282 and F323 posed immediate jeopardy from June 10, 2016 through July 15, 2016, a total of 36 days.10  CMS Ex. 1 at 1-4, 6, 8-9, 14, 22-23; CMS Reply at 2-3.

Petitioner argued that it returned to substantial compliance, breaking the period of immediate jeopardy on June 15, 2016.  I rejected that argument for reasons already discussed.  Petitioner also argues that there was no immediate jeopardy at all.  Petitioner argues that the evidence does not show a causal relationship between the improper transfer of Resident 67 on June 10, 2016, and her fractured femur.  Petitioner also argues that Resident 78 did not suffer serious injury, harm, impairment, or death – just a sunburn – on July 12, 2016.  P. Br. at 9-10.  Petitioner’s arguments do not satisfy Petitioner’s heavy burden to show that the declaration of immediate jeopardy was clearly erroneous.

Immediate jeopardy is defined as “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

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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 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.”11  In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

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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), 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,

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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 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.

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In the foregoing quotation from Mississippi Care Ctr. of Greenville,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 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.12  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 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.13  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

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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, 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 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 based on the violations of 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25(h), I have no definite and firm conviction that an error has been committed in the determination that immediate jeopardy existed from June 10 through July 15, 2016.

Petitioner has the burden to show the declaration of immediate jeopardy was clearly erroneous and has failed to meet that burden.  Resident 67’s care plan required a Hoyer™ lift and a two-person assist for transfers.  Petitioner’s CNA DS improperly transferred Resident 67 twice, alone, and without using a Hoyer™ lift.  CNA DS jeopardized Resident 67’s safety by failure to follow the resident’s care plan, twice creating a situation that put Resident 67 at risk for serious injury or harm.  Resident 67 had dementia, was totally dependent on staff for ADLs, and suffered from fragile bones.  It was imperative for Petitioner to ensure that she received adequate supervision and assistance devices for safe transfers.  Whether or not the improper transfers caused Resident 67’s femur fracture need not be determined.  All that is required for a finding of immediate jeopardy is a finding that there was or is a likelihood of serious injury, harm, impairment, or death.  Petitioner has not shown that the possible harm for Resident 67 met no reasonable definition of serious or that it was not likely.  Petitioner has not shown as clearly erroneous the surveyor’s determination that the CNA’s failure to transfer Resident 67 with a Hoyer™ lift and the required two-person assist created a likelihood that the resident could be seriously injured.

Resident 78 was abandoned for three hours in Petitioner’s hot courtyard.  Petitioner’s staff exposed Resident 78 to a number of dangers and caused him to suffer actual, serious harm.  Resident 78 required hospitalization and suffered, among other things, dehydration, hyperthermia, and second-degree sunburn on his shoulder.  It is fortuitous that Resident 78 was not more seriously harmed as a result of Petitioner’s failure to ensure its staff adequately supervised the resident.  Petitioner has not presented evidence that there was no likelihood for serious injury, harm, impairment, or death on account of its noncompliance.  I conclude that Petitioner has failed to show that the declaration of

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immediate jeopardy based on the violations of 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25(h) was clearly erroneous.

Accordingly, I conclude that Petitioner remained out of compliance at the immediate jeopardy level from June 10 through July 15, 2016.  Petitioner has not met its burden to show that CMS’s determination regarding the duration of the period of immediate jeopardy was clearly erroneous.14

9.  A CMP of $7,291 per day from June 10 through July 15, 2016, and a CMP of $303 per day from December 12, 2016 through January 9, 2017, are reasonable enforcement remedies.

I have concluded that Petitioner violated 42 C.F.R. §§ 483.20(k)(3)(ii), 483.25(h), 483.10(b)(4), 483.25(a)(3), 483.25(e)(2), 483.35(i), and 483.75(o)(1) and that the violations were 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 with 42 C.F.R. §§ 483.20(k)(3)(ii) and 483.25(h) was clearly erroneous during the period June 10 through July 15, 2016. 

The surveyors found that immediate jeopardy noncompliance began on June 10, 2016, but Petitioner abated the immediate jeopardy and returned to substantial compliance as of July 16, 2016.  The surveyors also found there was noncompliance which posed a risk for more than minimal harm without actual harm or immediate jeopardy from December 12, 2016 through January 9, 2017.  Petitioner has not challenged CMS’s determination that, following the second period of noncompliance, it returned to substantial compliance effective January 10, 2017.  CMS’s determination of the return to compliance date is consistent with Petitioner’s plan of correction which lists January 10, 2017, as the date Petitioner asserts it completed correction of the non-immediate jeopardy level deficiencies.  CMS Ex. 1 at 4-5, 7-14, 24-27; CMS Ex. 3.

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Petitioner argues that the proposed CMP is unreasonable, excessive, and punitive.  Petitioner argues that enforcement remedies are supposed to be remedial in nature, rather than punitive, with the purpose of encouraging prompt return to substantial compliance.  Petitioner contends that no CMP should have been imposed for the noncompliance cited as immediate jeopardy because they were citations of past noncompliance.  Petitioner argues that if a CMP was appropriate for the past noncompliance, a per instance CMP would have been appropriate on grounds that it is the “default remedy” for past noncompliance.  Petitioner argues no remedy should be imposed between June 16 and July 12, 2016, because it returned to substantial compliance as of June 15.  However, I have previously concluded that Petitioner did not return to substantial compliance between June 15 and July 12, 2016, and that Petitioner has failed to meet its burden to show that immediate jeopardy did not exist during that period.  Petitioner argues further that a “reasonable CMP” would be $1,500 per day from June 10, 2016 through June 15, 2016; July 12, 2016 through July 15, 2016; and December 12, 2016 through January 9, 2017.  Petitioner’s Prehearing Brief at 14-15 and App. 1; P. Br. at 10-13; P. Reply at 5.  I conclude Petitioner’s arguments are not persuasive.

Petitioner is correct that the regulations provided that enforcement remedies, including CMPs, are remedial in nature and are imposed with the purpose of ensuring “prompt compliance with program requirements.”  42 C.F.R. § 488.402(a).  The Board has never required that CMS show that a remedy it selects has a remedial purpose.  The Board has stated that the fact CMPs are included among authorized remedies for noncompliance shows that the Secretary has already determined that CMPs serve a remedial purpose and the Board is bound by that determination.  ALJs and the Board review whether a CMP is reasonable under the regulatory factors and can change the amount if they find the CMP is not reasonable based on the factors.  However, ALJs and the Board cannot eliminate the CMP or reduce it to zero under 42 C.F.R. § 488.438(3)(1).  Liberty Commons Nursing and Rehab. – Almance, DAB No. 2070 at 11 (2007), aff’d, Liberty Commons Nursing v. Leavitt, 285 F. App’x 37 (4th Cir. 2008).

The Secretary has also provided by regulation that CMS’s choice of sanctions to impose, including whether a CMP is to be imposed per day or per instance, is not subject to review.  42 C.F.R. §§ 488.408(g)(2), 498.3(d)(11).

Furthermore, and most significantly, Congress authorized the Secretary to remove immediate jeopardy and correct deficiencies by appointing temporary management of a facility.  Congress also authorized imposition of one or more of the other remedies specified in the statute, including termination, a CMP, denial of payment, and others.  Congress specified that nothing in section 1819(h) of the Act will be “construed as restricting the remedies available to the Secretary, to remedy” a SNF’s deficiencies.  Act § 1819(h)(2)(A).  Congress specifically addressed imposing a CMP for past noncompliance stating:

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If the Secretary finds, or pursuant to the recommendation of the State under [Act § 1819(1)] finds, that a skilled nursing facility meets such requirements but, as of a previous period, did not meet such requirements, the Secretary may provide for a civil money penalty under subparagraph (B)(ii) for the days on which he finds that the facility was not in compliance with such requirements.

Act § 1819(h)(2)(A).  Thus, Congress specifically authorized the use of a per day CMP for an instance of past noncompliance.  Whether or not CMS chooses to use a per day or per instance CMP for past noncompliance is, therefore, a choice of remedy and not subject to my review.

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 or not the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).  Pursuant to 81 Fed. Reg. 61,538 (Sep. 6, 2016), effective September 6, 2016, CMPs assessed after August 1, 2016 for noncompliance that occurred after November 2, 2015, are subject to ranges of higher amounts.  According to the table published in the Federal Register, the range of a per day CMP for immediate jeopardy noncompliance is $6,291 to $20,628 per day; for all other noncompliance the range is $103 to $6,188 per day; and the range for a per instance CMP is $2,063 to $20,628, whether or not there is immediate jeopardy.  81 Fed. Reg. at 61,549. 

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that  I may:  (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount. 

In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of non‑compliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as 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.

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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 – Almance, DAB No. 2070; 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).

I have received no evidence that Petitioner had a history of noncompliance prior to the survey 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.  By failing to act in accordance with federal participation requirements, Petitioner caused actual harm to Resident 78, risked serious harm or death for Residents 67 and 78, and amounted to a pattern of noncompliance that placed all of Petitioner’s residents at risk for more than minimal physical or emotional harm.

The CMP of $7,291 per day proposed by CMS for 36 days of immediate jeopardy, from June 10, 2016 through July 15, 2016, is above the middle of the authorized range, and I conclude it is reasonable based on my consideration of the regulatory factors.  I conclude that the $303 per day CMP proposed for the period of noncompliance from December 12, 2016 through January 9, 2017, is 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 June 10 through July 15, 2016, and from December 12, 2016 through January 9, 2017, due to violations of 42 C.F.R. §§ 483.25(h), 483.20(k)(3)(ii), 483.10(b)(4), 483.25(a)(3), 483.25(e)(2), 483.35(i), and 483.75(o)(1), each of which posed a risk for more than minimal harm;

The declaration of immediate jeopardy was not clearly erroneous; and

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Reasonable enforcement remedies are a CMP of $7,291 per day from June 10 through July 15, 2016, and a CMP of $303 per day from December 12, 2016 through January 9, 2017.

• 1. References are to the 2015 revision of the Code of Federal Regulations (C.F.R.), unless otherwise indicated.  In Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), an appellate panel of the Departmental Appeals Board (Board), after reviewing prior Board decisions, expressed a preference for applying the regulations in effect at the time of agency action rather than at the time of the events that were the basis for the agency action, at least in provider and supplier revocation cases.  Other appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted.  Good Shepard Home for the Aged, Inc., d/b/a The Good Shepherd Home, 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 immediate jeopardy was alleged occurred in June and July 2016.  The regulations with which Petitioner was bound to comply during the period June and July 2016 were in the 2015 revision of the C.F.R.  Other events occurred in December 2016, through completion of the survey on December 14, 2016.  Effective November 28, 2016, 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 December 2016 survey (Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1) and the January 27, 2017 initial determination by CMS (CMS Ex. 2) both occurred after the new regulations were in effect.  Therefore, the new regulations effective November 28, 2016, would arguably apply under the Board’s rationale in Kabat, Good Shepherd, Carmel and the cases cited therein, at least as to deficiencies that occurred after November 28, 2016.  However, the surveyors did not use the revised regulations effective November 28, 2016, for deficiencies that occurred after that date.  CMS also did not refer to the revised regulations in its initial determination.  Remand to CMS for revision of the Statement of Deficiencies (SOD) and a new initial determination was possible, but a needless act.  The most serious charges of the SOD are alleged under the provisions of the regulation in effect at the time of the events that were the subject of the alleged noncompliance.  The regulatory provisions cited were those for which Petitioner had notice and were binding upon Petitioner during the events in June and July 2016.  Remand to CMS for revision of the SOD and a new initial determination to cite the new regulations in effect at the time of the survey and the CMS initial determination, would be a needless and wasteful act.
• 2. SNFs and NFs are often referred to as long-term care facilities or nursing homes.  Participation of a NF 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.
• 3. Effective September 6, 2016, 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).  81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).
• 4. 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 similar to 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.
• 5. “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.
• 6. This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities.  The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, 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, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
• 7. 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 the SOM, ch. 7, § 7400E.  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 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 indicate a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are 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 optional at each level based upon the frequency of the deficiency.
• 8. The SOD states that Petitioner was in compliance as of “7/16/2017.”  CMS Ex. 1 at 15.  However, that is clearly a scrivener’s error as the survey was completed on December 14, 2016.
• 9. Petitioner also argues that the incident involving Resident 67 did not pose immediate jeopardy.  P. Br. at 9.  Petitioner’s argument regarding immediate jeopardy is discussed hereafter under the conclusion of law related to immediate jeopardy.
• 10. In the SOD, the surveyors mention in several places that immediate jeopardy was abated as of July 16, 2016.  CMS Ex. 1 at 2, 4, 8, 22, 24.  On page 15 of the SOD, however, the surveyors noted that immediate jeopardy was abated “as of 7/16/2017.”  CMS Ex. 1 at 15.  The reference to 2017 is clearly a scrivener’s error.
• 11. 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.
• 12. 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.
• 13. 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 can 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.
• 14. Petitioner’s plan of correction provided that its DON and Administrator would present the results of monitoring to the quality assurance committee for three months to ensure that compliance was being maintained and that any areas of concern identified would be addressed.  CMS Ex. 1 at 23-24.  This provision of the plan of correction shows that Petitioner’s goal of achieving compliance remained a work in progress and suggests CMS’s finding that immediate jeopardy was abated as of July 16, 2016, was charitable.  Nevertheless, I do not disturb CMS’s finding that immediate jeopardy was abated as of July 16, 2016.