Hilltop Park Rehabilitation and Care Center, DAB CR5627 (2020)

DECISION

Petitioner, Hilltop Park Rehabilitation and Care Center, was not in substantial compliance with program participation requirements beginning November 25, 2015 and continuing through March 17, 2016.  A civil money penalty (CMP) of $6,550 per day from November 25 through December 18, 2015, a CMP of $1,100 per day from December 19, 2015 through February 19, 2016, and a CMP of $200 per day from February 20 through March 17, 2016, a total CMP of $231,900, is a reasonable enforcement remedy.

I.  Background

Petitioner is located in Weatherford, Texas, and participates in Medicare as a skilled nursing facility (SNF) and in Medicaid as a nursing facility (NF).  Centers for Medicare & Medicaid Services (CMS) exhibits (Exs.) 1 at 1, 2 at 1, 3, 4, 21.

On March 15, 2016, CMS notified Petitioner that it concurred with the findings of a recertification survey and complaint investigation completed at Petitioner’s facility by the Texas Department of Aging and Disability Services (state agency) on February 19, 2016.  CMS advised Petitioner that the state agency found multiple instances of noncompliance.  CMS advised Petitioner that it was imposing a CMP; a denial of payments for new

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admissions (DPNA) effective March 22, 2016, if Petitioner failed to return to substantial compliance before that date or the date its provider agreement was terminated; and that Petitioner’s provider agreement would be terminated August 19, 2016, if Petitioner did not return to substantial compliance before that date.  CMS Ex. 1.

On May 6, 2016, Petitioner requested a hearing before an administrative law judge (ALJ).  The case was assigned to me for hearing and decision on May 10, 2016, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at my direction.

By letter dated May 24, 2016, CMS notified Petitioner that the state agency determined that Petitioner returned to substantial compliance effective March 18, 2016.  Therefore, CMS rescinded the mandatory termination and the DPNA.  CMS advised Petitioner that it was imposing a CMP of $6,550 per day for the period December 28, 2015 through February 7, 2016, and $1,100 per day for the period February 8 through March 17, 2016.  CMS Ex. 2 at 1.  However, on August 3, 2016, based on a revised certification of noncompliance by the state agency, CMS revised its initial determination related to the proposed CMP to the following:  a CMP of $6,550 per day for the period November 25 through December 18, 2015; $1,100 per day from December 19, 2015 through February 19, 2016, and $200 per day from February 20 through March 17, 2016.  CMS Ex. 21 at 1.

On November 7, 2016, CMS filed a motion for summary judgment.  CMS advised me by its motion that it was proceeding only on the following allegations of noncompliance:  42 C.F.R. §§ 483.25(h) 1 (Tag F323,2 scope and severity (s/s) K),3 483.25(l) (Tag F329,

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s/s E), 483.25(m)(2) (Tag F333, s/s E), 483.35(d)(1)‑(2) (Tag F364, s/s F), and 483.60(a)‑(b) (Tag F425, s/s E).  In its request for hearing, Petitioner contested each of the alleged deficiencies upon which CMS is proceeding.  I concluded that CMS was not entitled to summary judgment as to those alleged deficiencies.  Petitioner was also cited for violation of 42 C.F.R. § 483.70(a) based on 11 Life Safety Code violations.  There is no dispute that Petitioner did not request review of the Life Safety Code violations (Request for Hearing, Tr. 30-31) and the findings and conclusions of noncompliance under 42 C.F.R. § 488.70(a) based on those violations are final and binding upon Petitioner.  42 C.F.R. §§ 498.20(b), 498.40.  I granted partial summary judgment in favor of CMS as there is no dispute that Petitioner waived review of whether it was in substantial compliance based on the Life Safety Code violations.  However, noting that those violations alone would support a CMP in the lower range of CMPs authorized, I concluded that Petitioner preserved the issue of the reasonableness of the CMS proposed enforcement remedies based on the alleged noncompliance remaining at issue and the Life Safety Code violations.  Ruling Granting, In Part, and Denying, In Part, Respondent’s Motion for Summary Judgment and Order to File Amended Joint Status Report, issued February 2, 2017.

I convened a hearing by video teleconference on February 13 and 14, 2018.  A transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 8 and 10 through 25, which were admitted as evidence.4   Tr. 32-37.  Petitioner offered Petitioner’s exhibits (P. Exs.) 1 through 22, and P. Exs. 11 through 22 were admitted as evidence.5

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Tr. 38‑39.  CMS called the following witnesses:  Surveyor Wendy Parker, Registered Nurse (RN), and Daniel McElroy, RN, Nurse Consultant with CMS.  Petitioner called the following witnesses:  Tammy Ashford, RN, Petitioner’s Director of Nursing (DON), and Pearl Merritt, EdD, MSN, RN.

On July 31, 2018, CMS filed a post‑hearing brief (CMS Br.) and on August 31, 2018, Petitioner filed its post‑hearing brief (P. Br.).  The parties filed simultaneous replies on October 1, 2018 (CMS Reply and P. Reply, respectively).

II.  Discussion

A.  Issues

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

Whether the remedy imposed is reasonable.

B.  Applicable Law

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 to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.6   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

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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 long-term care facility that is not complying substantially with federal participation requirements.  “Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (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, subpart B.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm. 

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

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

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to

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appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aid training and competency evaluation program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

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.7   Rather, the Board has long held that the

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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 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.  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 as to each allegation of noncompliance.

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

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evidence given the greatest weight in my decision-making.8   I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. & Prac. § 5:64 (3d ed. 2013).

The alleged noncompliance at issue before me based upon the survey completed on February 19, 2016, are alleged violations of 42 C.F.R. §§ 483.25(h) (Tag F323), 483.25(l) (Tag F329), 483.25(m)(2) (Tag F333), 483.35(d)(1)‑(2) (Tag F364), and 483.60(a)‑(b) (Tag F425).  CMS Br.; CMS Reply; CMS Ex. 3.  CMS alleges that the noncompliance under Tag F323 posed immediate jeopardy to one or more of Petitioner’s residents from November 25, 2015 to February 19, 2016.  CMS Br. at 16; CMS Reply at 5.  The noncompliance under Tags F329, F333, F364, and F425 are all alleged to have posed a risk for more than minimal harm without actual harm or immediate jeopardy.  CMS Ex. 3.  The alleged deficiencies are considered as follows.

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

2.  The declaration of immediate jeopardy related to the noncompliance at 42 C.F.R. § 483.25(h) was not clearly erroneous.

a.  Facts

Resident 12 is the only resident involved in this deficiency citation.  Resident 12 was 87 years old when she fell from her wheelchair onto Petitioner’s parking lot on December 18, 2015.  P. Ex. 17.  She was admitted to Petitioner’s facility on July 1, 2014.  CMS Ex. 12 at 9.  Resident 12’s Minimum Data Set (MDS) with an assessment reference date of July 29, 2015 (CMS Ex. 12 at 164) lists diagnoses including diabetes mellitus, Alzheimer’s disease, depression, hypopotassemia, insomnia, and chronic pain.  CMS Ex. 12 at 178-79.  Resident 12’s MDS with an assessment reference date of January 6, 2016 (CMS Ex. 12 at 245) lists diagnoses including cancer, anemia, hypertension, diabetes mellitus, Alzheimer’s disease, anxiety disorder, depression, psychotic disorder, allergic rhinitis, muscle wasting and atrophy, history of falls, hypokalemia, pain,

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thrombocytopenia, insomnia, and chronic pain.  CMS Ex. 12 at 258-59.  Her “Admission Record” dated February 3, 2016, shows that she was receiving hospice care for myelodysplastic syndrome (CMS Ex. 12 at 221, 234) and lists diagnoses including anxiety disorder, muscle wasting and atrophy, history of falling Alzheimer’s disease, hypokalemia, major depressive disorder, myelodysplastic syndrome, anemia, thrombocytopenia, type 2 diabetes mellitus without complications, brief psychotic disorder, insomnia, essential hypertension, and unspecified urinary incontinence.  CMS Ex. 12 at 9‑10.

A social services note dated November 14, 2014, recorded that the resident was alert but increasingly confused.  The resident did not know where she was or why she was there.  Resident 12 would attempt to stand or transfer without assistance and fall.  CMS Ex. 12 at 229.

An elopement risk assessment dated February 11, 2015, assessed Resident 12 as at risk to elope.  CMS Ex. 12 at 102.  Petitioner’s elopement policy required that “[a]ny resident who is determined to be an elopement risk will be placed on High Risk protocols as per policy.”  CMS Ex. 22 at 2.  The evidence does not show what Petitioner’s high risk protocols were.  The surveyors found no evidence that Resident 12’s interdisciplinary team (IDT) developed a care plan to address the resident’s risk for elopement and there is none in evidence before me.  Tr. 107-08, 214.

The MDS with an assessment reference date of July 29, 2015, shows Resident 12 was assessed as suffering disorganized thinking, she required extensive assistance of one staff member for transfers including standing, she was unable to walk, and used a walker or wheelchair for mobility.  The resident was assessed as not exhibiting wandering behavior that placed her at risk for dangerous locations including elopement.  CMS Ex. 12 at 164, 167, 172, 175-76.  The assessment that the resident was not at risk for elopement is inconsistent with the February 11, 2015 assessment that she was at risk to elope but it is understood that the MDS is based solely upon the seven-day assessment period.  An MDS with an assessment reference date of January 6, 2016, after the December 18, 2015 elopement and fall, assessed the resident as at significant risk for wandering and getting into dangerous places, including elopement.  CMS Ex. 12 at 245, 252.

A care plan dated July 31, 2014, indicates that Resident 12 was at risk for injury due to falls, and required the use of a pressure alarm (not clear if on her bed or wheelchair), use of a low bed with a mat, monitoring the use of a wander guard device, and monitoring the resident’s location every two hours.  CMS Ex. 12 at 137.  A care plan with an onset date of March 28, 2015, updated August 6, 2015, states that Resident 12 was at risk for falls.  Interventions listed include notifying her physician and family in the event of a fall; monitoring for 72 hours for injury from a fall; neurologic checks for 72 hours after a fall if necessary; encouraging the resident to use her call light; assisting her as needed; reporting changes in endurance, ambulation, and transfers; frequent monitoring;

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repositioning for comfort and safety; assessing her medications as a possible factor contributing to falls; updating her fall assessment; keeping her living area well lighted during hours she was awake; keeping her room free of clutter; and frequent checks.  CMS Ex. 12 at 66.  A care plan with an onset date of January 20, 2015, updated on February 19, 2015, and August 6, 2015, also identified Resident 12 as at risk for falls, and listed most of the same interventions as the March 28, 2015 care plan.  CMS Ex. 12 at 77.  The evidence also includes a fall care plan dated August 24, 2015, with most of the same interventions plus a requirement for a floor mat and pressure alarm.  CMS Ex. 12 at 138.  Physician orders dated August 5 and 7, 2015, show that both a wheelchair and bed alarm were ordered and they were to be checked every shift.  CMS Ex. 12 at 207.  A fall risk assessment dated November 17, 2015, continued to assess Resident 12 as at high risk for falls.  CMS Ex. 12 at 106.

Resident 12 had a history of falls with injuries.  A physician ordered on August 24, 2015, that Resident 12’s right shoulder, arm, and wrist be x-rayed due to a fall.  CMS Ex. 12 at 211.  A doctor’s progress note dated September 19, 2015, records that Resident 12 fell on September 16, 2015, with multiple bruises on her knees, thigh, and abdomen.  The note shows that the resident had also fallen just two weeks previously also with bruising.  The physician noted he had not been called about the falls and he discussed that and the resident’s lack of safety awareness with nursing staff.  CMS Ex. 12 at 228.  A nurse’s note dated November 15, 2015 at 7:30 p.m., indicates Resident 12 fell due to an unassisted transfer.  Petitioner’s accident/incident report records that on November 15, 2015 at about 7:30 p.m., Resident 12 fell near the nurse’s station.  The resident was seeking attention, attempted to stand, her wheelchair brake was not on, and she slid to the floor with staff assistance when she attempted to sit down in the wheelchair.  No injury was recorded.  The intervention to address the fall was anti-anxiety measures.  CMS Ex. 12 at 40-42.  On November 17, 2015 at 6:30 p.m., the resident was reported to have increased confusion, and she was repeatedly attempting to stand up and walk.  The nurse’s note indicates the resident was easily redirected and she had her chair alarm on.  A note dated November 17, 2015 at 8:15 p.m., shows that Resident 12 was found on the floor in front of the nurse’s station.  On November 18, 2015 at 1:00 a.m., the resident was at the nurse’s station repeatedly attempting to stand without assistance.

Resident 12 also began to have exit-seeking behaviors beginning in November 2015.  A nurse’s note dated November 25, 2015 at 5:00 a.m., reports that Resident 12 was repeatedly attempting to stand and attempting to exit the facility through the front door.  The resident had increased confusion and redirection was unsuccessful.  CMS Ex. 12 at 99.  The note does not indicate that any intervention to address the exit-seeking behavior was successfully implemented.  A nurse’s note dated December 4, 2015 at 1:45 p.m., describes the resident as wandering and exit seeking.  The note states the resident sat at the front door until someone entered and then the resident attempt to exit in her wheelchair.  The note does not indicate what intervention was implemented to address the behavior.  CMS Ex. 12 at 101.  The record contains no evidence that the resident’s

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exit‑seeking behavior on November 25 and December 4, 2015, was assessed or addressed by her interdisciplinary team, and there are no physician orders or care plan related to the behavior.  Tr. 234, 246.  Petitioner’s elopement assessment forms specify that if a resident’s elopement assessment score indicates the resident is at risk for elopement, the care plan on the back of the form is to be initiated.  CMS Ex. 12 at 102-04.  The backs of the assessment forms do not appear in evidence.9   However, Surveyor Wendy Parker testified at hearing that she saw the backs of the forms during the survey and saw that they were not completed.  Tr. 75, 237.

There is no dispute that on December 18, 2015, Resident 12 exited Petitioner’s facility through an unlocked back door and fell from her wheelchair to the parking lot sustaining injuries.  A nurse’s note dated December 18, 2015 at 8:30 p.m., records that when the nurse was returning from her break at about 8:35 p.m. she found Resident 12 laying on her right side on the parking lot about 15 feet from an exit door that remained unlocked at all times.  The nurse noted a laceration and abrasions with blood on the resident’s head.  The resident’s physician was contacted and he ordered that the resident be taken to the emergency room for evaluation.  CMS Ex. 12 at 11, 100; P. Ex. 16 at 1.  Another nurse’s note dated December 18, 2015 at 8:35 p.m. records that pressure was applied to the laceration and the resident, who was outside in a shirt without a jacket, complained of being cold.  CMS Ex. 12 at 13.  Resident 12’s physician ordered that she be sent to the emergency room for evaluation and treatment.  CMS Ex. 12 at 218.

Petitioner’s accident/incident report records that on December 18, 2015 at about 8:30 to 8:40 p.m., Resident 12 fell in the parking lot.  The fall was unobserved.  She was found lying on her right side with a large hematoma and laceration on her forehead with moderate bleeding and she was ordered to the emergency room.  CMS Ex. 12 at 43; P. Ex. 17.  One staff statement taken as part of the investigation shows that a staff member observed the resident had increased wandering behavior at about 7:30 p.m.  P. Ex. 17 at 6.  A staff member reported in her statement that she saw the resident wandering on the 400 hall and the staff member redirected the resident back to the 500 hall.  P. Ex. 17 at 11.  Another staff member gave a statement in which she states she observed Resident 12

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attempting to exit from the 400 hall back door, and she redirected the resident without stating that the redirection was effective or when it occurred.  P. Ex. 17 at 8.  Petitioner’s investigation shows that during the evening of December 18, 2015, within about an hour of the resident’s elopement and fall, at least three staff members saw the resident wandering and one witnessed her attempt to exit a back door.  The only intervention attempted was redirection.  There is no indication that the observed wandering or exit‑seeking behaviors were reported to a nurse in charge.

A consultation report dated December 21, 2015, while Resident 12 was being treated at the hospital, records that Resident 12 suffered extensive traumatic wounds to her face, scalp, and a nasal bone fracture due to the fall on the parking lot.  During the consultation she was in pain and had a laceration on her nasal bridge, a wound on her forehead with bruising and hematoma, and a wound on her right hand.  CMS Ex. 12 at 21-22, 30-31.

The record includes a care plan dated December 18, 2015, that lists as a problem a witnessed fall.  The care plan includes most of the same interventions as the prior fall care plans.  It does not mention a risk for elopement.  CMS Ex. 12 at 139.  Because the problem is described as a witnessed fall and her fall on December 18, 2015, was unwitnessed, I infer this care plan was not developed in response to the December 18 elopement and fall.  Petitioner placed in evidence a document that indicates that Petitioner’s staff was to check Resident 12 every hour (P. Ex. 16 at 2), but this intervention does not appear in a care plan prior to December 18, 2015.

Petitioner offered unsworn statements without objection by CMS.  The statements indicate that the staff who provided statements had not known Resident 12 to elope.  The statements are consistent with the absence of any evidence of any prior elopement by the resident.  Some of the statements indicate that staff did not observe exit‑seeking behavior on December 18, 2015, and if they had seen such behavior they knew to redirect the resident.  The statements do not show that the interviewed staff witnessed exit‑seeking behavior on the day prior to the elopement.  Some statements indicate that in the past redirection had been effective with Resident 12.  P. Ex. 15.  The statements are inconsistent with the evidence that shows the resident had exit‑seeking behavior and that redirection was not effective when the resident was attempting to exit the facility on November 25, 2015.  CMS Ex. 12 at 99.  Nurse’s notes from December 4, 2015, show exit‑seeking behavior but do not indicate what intervention was attempted or if any intervention was effective.  CMS Ex. 12 at 101.  Petitioner’s social worker states in an unsworn statement that she never observed Resident 12 attempt to push open a door or leave the facility.  The social worker does not state whether or not she was aware of prior exit‑seeking behaviors on November 25 and December 4, 2015, but as the social worker she should have been aware of those behaviors.  P. Ex. 18 at 2.

Tammy Ashcraft, RN, Petitioner’s DON, testified.  Tr. 378, 381.  DON Ashcraft testified that the door Resident 12 eloped from is closer to the SNF than the assisted living

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facility.  The door was near the employee breakroom where they clocked-in.  The door was never locked.  Tr. 384.  DON Ashcraft did not explain why the door was not locked, and I infer it was for the convenience of staff.  Resident 12 wandered the facility in her wheelchair and would come to DON Ashcraft’s office.  The resident liked to have others speak to her even though she did not respond.  Tr. 384-86.  She testified that the resident’s son used to enter the facility through the unlocked employee door through which the resident eloped.  Tr. 390.  DON Ashcraft did not think Resident 12 was at risk to elope.  Tr. 392-93.  Her opinion that Resident 12 was not at risk to elope is not credible given the evidence of exit seeking on November 25 and December 4, 2015, and the prior elopement assessment in the spring of 2015.  She testified that normally staff check on residents every two hours and as needed.  Tr. 394.  Resident 12 was being monitored more frequently because her son had just died, she had been sick, she was moved to a different room, and she was confused.  Around November 25, 2015, when the resident was reported to have been exit seeking she had just been diagnosed with a urinary tract infection (UTI).  DON Ashcraft agreed with counsel that although the nurse’s note for that day showed redirection was not successful, the resident did not elope on November 25, 2015.  The fact DON Ashcraft did not know what intervention was used to prevent the elopement is troubling.  DON Ashcraft’s lack of knowledge is consistent with the fact the record includes no assessment by the resident’s IDT that evaluated the cause for the resident’s exit seeking or the development of appropriate interventions to address the exit seeking.  On December 4, 2015, the resident’s son was admitted to the facility and Resident 12 was moved into his room on a different hall of the facility.  DON Ashcraft observed that Resident 12 seemed more confused at that point and seemed to be trying to go back to her old room or find something familiar.  However, DON Ashcraft testified that she did not think that created a higher risk for Resident 12 to elope.  She interpreted the nurse’s note for December 4, 2015 (P. Ex. 14) to mean that staff was monitoring the resident more frequently, they were aware she was attempting to exit the front door and were redirecting her, and they were making sure they knew where the resident was.  She testified that staff would document hourly checks only if there was a problem.  She opined that there is no requirement for one-on-one supervision.  She testified that there was no requirement to document hourly checks on any particular form.  Tr. 394-401.  She opined, based on her experience and knowledge of Resident 12, that there was nothing more Petitioner’s staff could have done to prevent Resident 12 from eloping and falling on December 18, 2015.  Tr. 432.  On cross-examination, she verified that the Code Orange policy dated 2003 was in effect at the time Resident 12 attempted to elope on November 25 and December 4, 2015, and when the resident successfully eloped on December 18, 2015.  When asked whether Resident 12 was placed on high risk protocols as required by Petitioner’s Code Orange policy, she testified the resident was being checked hourly and was involved in activities.  She testified that the resident was easily redirected or there were extenuating circumstances when the resident attempted to elope, but she did not specify what circumstances she thought were extenuating.  She testified that Resident 12 had bed and chair alarms, a low bed, and a fall mat by her bed.  I note that these interventions are helpful inside the facility where alarms may be heard causing

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direct intervention by staff and low beds and mats minimize injury from a fall.  However, once a resident is outside the facility, the low bed and mat are not effective and the wheelchair alarm would be effective only if heard by someone.  DON Ashcraft testified that although the nurse’s note from November 25, 2015, stated that redirection failed when the resident was exit seeking, she believed that was wrong because the resident did not elope.  She agreed that Resident 12 was exit seeking earlier in the evening on December 18, 2015, but the door involved was locked.  Tr. 447-51.

Petitioner called and qualified as an expert witness Pearl Merritt, RN, BSN, Ed.D, Regional Dean of the Texas Tech School of Nursing.  Tr. 479-81; P. Ex. 20.  Dr. Merritt testified that she reviewed records related to Resident 12 provided by counsel for Petitioner.  Tr. 492-93.  She testified that there is no guarantee that there will not be falls and accidents; there is no regulation that requires one-on-one supervision in a nursing home; and one-on-one supervision is not practical.  She testified that the regulations and CMS guidance do not define the term adequate supervision.  She testified that there is no requirement that interventions to address a risk for elopement be in a care plan specifically labeled as an elopement care plan.  Tr. 494-96.  She opined that Petitioner had adequate interventions in place to address Resident 12’s risk for elopement, including hourly checks; a wheelchair alarm; and activities.  She opined Resident 12 did not need to be on a locked unit prior to her elopement.  Tr. 497-500.  She opined that documenting hourly checks is good practice but not required or necessary.  Tr. 502-03.  She opined that there was no imminent threat for Resident 12 on November 25, 2015, and there was no such threat through December 18, 2015.  She opined redirection was effective.  Tr. 505-07.  She testified that Petitioner provided its staff elopement and risk assessment training.  Tr. 509.  She opined that Petitioner’s interventions were appropriate.  Tr. 512-18.  She opined that there was no other intervention that could have prevented Resident 12’s elopement and fall.  Tr. 523-24.  Dr. Merritt is clearly knowledgeable and generally very credible.  However, I do not find credible or weighty her opinion that there was no other intervention or nothing more Petitioner could have done to minimize the risk that Resident 12 would elope and be injured by a fall from her wheelchair while unsupervised in the facility parking lot.  A lay person can readily identify two interventions that would have prevented or minimized the possibility of elopement and the subsequent fall:  locking the back door or at least constant monitoring of the door to minimize or prevent the chance for an unsupervised exit, and persistent or constant monitoring of Resident 12 while she was displaying signs of exit seeking.  The fact that locking the back door may have been inconvenient for staff is not a more important consideration than protecting residents from elopement and associated risks, and Dr. Merritt clearly knows that.  Further, while constant supervision may be extremely burdensome on staff and management, the fact is that Resident 12’s exit‑seeking behaviors were clear and apparently brief in duration.  Again the inconvenience for staff certainly cannot outweigh the need to protect residents from harm secondary to elopement and Dr. Merritt clearly knows that.  I conclude Dr. Merritt’s opinion that Petitioner did all it could and all it should be required to do is simply not credible or weighty.

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b.  Analysis

The Statement of Deficiencies (SOD) alleges that the basis for this deficiency is that:

Petitioner failed to provide adequate supervision for Resident 12 who had a history of exit‑seeking behavior; and

Petitioner failed to develop a care plan to address the exit‑seeking behavior with specific interventions to prevent elopement.10

The SOD stated immediate jeopardy was removed on February 19, 2016.  However, the deficiency continued at a scope and severity of actual harm without immediate jeopardy because Petitioner was still in the process of implementing its plan of correction.  The SOD states that there was a pattern of noncompliance because the surveyors identified five residents who were potentially subject to harm because they, like Resident 12, had wandering behaviors, were independently mobile and confused, and were at risk for injury and death due to elopement.  CMS Ex. 3 at 2-3.

Surveyor Wendy Parker testified during the hearing that she cited the deficiency because numerous staff members told her that the door through which Resident 12 eloped remained unlocked at all times and that the door was not visible down the hallway.  Her testimony is consistent with the evidence.  Tr. 95-96;CMS Ex. 12 at 11, 100; CMS Ex. 20 at 16, 24; P. Ex. 16 at 1.  Surveyor Parker testified that had the door been locked, Resident 12 would likely not have been able to exit without anyone seeing her leave.  Tr. 96-97.

The regulation requires:

(h) Accidents.  The facility must ensure that—

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

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

42 C.F.R. § 483.25(h).

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At the time of the February 2016 survey, CMS instructed its surveyors that the intent of 42 C.F.R. § 483.25(h)(1) and (2) was “to ensure the facility provides an environment that is free from accident hazards over which the facility has control and provides supervision and assistive devices to each resident to prevent avoidable accidents.”  The facility is expected to:  identify, evaluate, and analyze hazards and risks; implement interventions to reduce hazards and risks; and monitor the effectiveness of interventions and modify them when necessary.  SOM, app. PP, F323 (rev. 27; eff. Aug. 17, 2007).

The Board has provided interpretative guidance for adjudicating alleged violations of 42 C.F.R. § 483.25(h)(1):

The standard in section 483.25(h)(1) itself – that a facility “ensure that the environment is as free of accident hazards as possible” in order to meet the quality of care goal in section 483.25 – places a continuum of affirmative duties on a facility.  A facility must determine whether any condition exists in the environment that could endanger a resident’s safety.  If so, the facility must remove that condition if possible, and, when not possible, it must take action to protect residents from the danger posed by that condition.  [Footnote omitted.]  If a facility has identified and planned for a hazard and then failed to follow its own plan, that may be sufficient to show a lack of compliance with [the] regulatory requirement.  In other cases, an ALJ may need to consider the actions the facility took to identify, remove, or protect residents from the hazard.  Where a facility alleges (or shows) that it did not know that a hazard existed, the facility cannot prevail if it could have reasonably foreseen that an endangering condition existed either generally or for a particular resident or residents.

Maine Veterans’ Home – Scarborough,DAB No. 1975 at 6-7 (2005).

The Board has also explained the requirements of 42 C.F.R. § 483.25(h)(2) in numerous other decisions.  Golden Living Ctr. – Riverchase,DAB No. 2314 at 7-8 (2010); Eastwood Convalescent Ctr., DAB No. 2088 at 4 (2007); Century Care of Crystal Coast, DAB No. 2076 at 6-7 (2007), aff’d, Century Care of Crystal Coast v. Leavitt, 281 F. App’x 180 (4th Cir. 2008); Liberty Commons Nursing & Rehab - Alamance, DAB No. 2070 at 2-3 (2007); Golden Age Skilled Nursing & Rehab. Ctr., DAB No. 2026 (2006); Ne. Ohio Alzheimer’s Research Ctr., DAB No. 1935 (2004); Woodstock Care Ctr., DAB

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No. 1726 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Board has often stated that the regulations do not make a facility strictly liable11 for accidents that occur or a failure to deliver adequate supervision and assistance devices.  Rather it is necessary to look at what the facility did or did not do in any given situation to determine whether the actions of the facility were reasonable and adequate.  In Woodstock, the Board stated that “while the regulations do not make facilities unconditional guarantors of favorable outcomes, the quality of care provisions do impose an affirmative duty to provide services (in this case, supervision and devices to prevent accidents) designed to achieve those outcomes to the highest practicable degree.”  Woodstock,DAB No. 1726 at 25.  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 the ability of the resident to protect him or herself from harm.  Id. at 29-30.  More specifically:

The regulation speaks in terms of ensuring that what is “practicable” and “possible” to do is done.  What is thus required of facilities is not prescience but reason and professional judgment in assessing what can be done to make residents (given their special needs) safe, through removing accident hazards, providing appropriate devices, and ensuring adequate supervision.

Glenoaks Nursing Ctr.,DAB No. 2522 at 8 (2013) (citing Josephine Sunset Home,DAB No. 1908 at 14-15 (2004); Briarwood Nursing Ctr.,DAB No. 2115 at 11-12 (2007)).

The SOM defines an “accident” as “any unexpected or unintentional incident, which results or may result in an injury or illness to a resident.”  SOM, app. PP, Guidance F323 (rev. 27; eff. Aug. 17, 2007).  The mere occurrence of an accident does not, by itself, prove that a facility provided inadequate supervision; however, when “an accident does occur, the circumstances surrounding an accident (or apparent accident) may support an inference that the facility’s supervision of a resident was inadequate.”  Lake Park Nursing

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and Rehab. Ctr.,DAB No. 2035 at 8 (2006) (citing St. Catherine’s Care Center of Findlay, Inc., DAB No. 1964 (2005).

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(h) that posed a risk for more than minimal harm to Resident 12.  Resident 12 was assessed on February 11, 2015, as at risk to elope.  CMS Ex. 12 at 102.  Petitioner’s elopement policy required that because Resident 12 was assessed as at risk to elope, she was to be placed on Petitioner’s high risk protocols, which are not described in the record.  CMS Ex. 22 at 2.  On November 25, 2015, the resident repeatedly attempted to stand and exit the facility through the front door.  Staff reported that attempts to redirect the resident were unsuccessful.  CMS Ex. 12 at 99.  On December 4, 2015, Resident 12 again attempted to get out the front door.  CMS Ex. 12 at 101.  On December 18, 2015, staff observed Resident 12 attempting to exit the facility but the resident was redirected.  P. Ex. 17 at 8.  Subsequently, on December 18, 2015 at about 8:30 p.m., Resident 12 did exit the facility without knowledge of staff and she tipped over in her wheelchair on the facility parking lot suffering actual harm.  The evidence clearly shows that Resident 12 was assessed as at risk to fall and several care plans for falling with interventions are in evidence.  Resident 12 was also clearly assessed as at risk to elope.  Therefore, it was foreseeable that Resident 12 might elope and suffer injury due to a fall if she had inadequate supervision.  Resident 12 did elope and suffer injury due to a fall.  The evidence shows that it is more likely than not that Petitioner failed to implement adequate interventions to minimize that risk of injury to Resident 12 due to elopement.  Accordingly, CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(h)(2) that resulted in actual harm.

Thus, the burden is upon Petitioner to show by a preponderance of the evidence that it remained in compliance with 42 C.F.R. § 483.25(h), that any noncompliance posed no risk for more than minimal harm, or that it had an affirmative defense.  I conclude Petitioner has failed to meet its burden.

Pursuant to 42 C.F.R. § 483.20(k), Petitioner was required to ensure a comprehensive care plan was developed for Resident 12 to meet her medical, nursing, mental and psychosocial needs.  42 C.F.R. § 483.20(k)(1).  The comprehensive care plan must be developed by the resident’s IDT that includes her physician, a registered nurse responsible for Resident 12, and staff in the appropriate disciplines to address the resident’s needs.  42 C.F.R. § 483.20(k)(2)(ii).  The care plan must be periodically reviewed and revised by a qualified team12 after each assessment.  42 C.F.R.

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§ 483.20(k)(2)(iii).  Petitioner has failed to present evidence that a qualified team reviewed and revised Resident 12’s comprehensive care plan based on the elopement risk assessment on February 11, 2015, which showed that Resident 12 was at risk for elopement.  Similarly, Petitioner has failed to present any evidence that Resident 12’s IDT or a qualified team reviewed her comprehensive care plan following her exit-seeking behaviors on November 25 and December 4, 2015, which clearly demonstrated that the resident’s condition was such that elopement was foreseeable absent specific interventions developed by the IDT to be implemented by staff.

Petitioner makes several arguments to the effect that it adequately addressed Resident 12’s needs for care and services including supervision relative to her identified and foreseeable risk for elopement and accidental injury secondary to elopement.  Petitioner’s arguments are not persuasive that Petitioner was more likely than not in compliance with 42 C.F.R. § 483.25(h) or that any noncompliance posed no risk for more than minimal harm.

Petitioner argues that 42 C.F.R. § 483.25(h) imposes two requirements on a facility, to remove or eliminate accident hazards, and to provide supervision and assistance devices to prevent accidents.  P. Br. at 2.  Actually, the regulation only requires that “[t]he resident environment remains as free of accident hazards as is possible . . . .”  42 C.F.R. § 483.25(h)(1).  The regulation does not require removing all accident hazards but only those possible to remove and only those that are in the resident environment.  If an accident hazard cannot be removed a facility must take some reasonable action to protect its residents against the hazard.  Petitioner argues that the surveyors did not identify an accident hazard in this case.  However, Petitioner’s argument is erroneous.  There is no question that Resident 12 exited Petitioner’s facility through an unlocked door that was used as a staff entrance and exit.  The door could be accessed by any resident and at least the inside of the door was in the resident environment.  There is no evidence that Petitioner had a process for monitoring who had access to the door.  Petitioner cannot credibly argue that a door to the outside of a nursing home does not pose accident hazards, such as tripping over the threshold, allowing the door to close on one’s fingers, an active parking lot, an area with uneven surfaces, or adverse outdoor weather conditions.  Petitioner was clearly aware of the existence of the door, that it was unlocked, that it was accessible to residents, and that a resident could exit the door unobserved, and without supervision.  Surveyor Parker clearly alleged in the SOD that Resident 12 exited the door without supervision and then fell, suffering injury when her wheelchair tipped over.  CMS Ex. 3 at 4-6.  Surveyor Parker testified during the hearing

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that she cited the deficiency because the door through which Resident 12 eloped remained unlocked at all times and that the door was not visible down the hallway, and if that door had not been unlocked Resident 12 could not have eloped.  Tr. 95-97;CMS Ex. 12 at 11, 100; CMS Ex. 20 at 16, 24; P. Ex. 16 at 1.  Although in drafting the SOD Surveyor Parker did not specifically describe the door as an accident hazard that Petitioner failed to eliminate or mitigate, that allegation is implicit in the citation of deficiency, i.e., had the door been locked there could have been no unobserved elopement through that door or injury secondary to passing through the door into an uncontrolled environment.  CMS Ex. 3 at 2-22.  Petitioner was aware of the door through which Resident 12 eloped, that it was unlocked, that it was regularly used by staff to enter and exit, and that it was accessible by residents of both the SNF and the assisted living facility.  Tr. 383-84.  Petitioner was also aware that there were previously doors in place that separated the SNF from the door through which Resident 12 eloped because there was a door frame from which a set of double doors had been removed.  As part of the plan of correction Petitioner rehung the doors and added an alarm.  Tr. 425-26.  Petitioner clearly knew that Resident 12 was at risk for falling and many interventions were in place to reduce the risk for falls.  P. Ex. 11.  In February 2015, Petitioner assessed Resident 12 as at risk for elopement and was then on notice of that risk.  A successful elopement increases the risk for falling due to the various hazards outside a facility that are not mitigated, such as uneven terrain, sidewalks, curbs, pot holes and similar hazards.  Based on Resident 12’s exit-seeking behaviors on November 25 and December 4, 2015, the risk for elopement certainly increased over the prior risk as the resident was then actively trying to elope.  The unlocked door that was not under continuous or, at least, frequent observation by Petitioner’s staff was an invitation to an accident that only required that Resident 12 find it.  Petitioner could have easily mitigated or eliminated the risk by installing a lock, blocking resident access, placing the door under regular frequent observation, or any combination of interventions.  However, Petitioner failed to do so leaving the accident hazard that Resident 12 ultimately found the evening of December 18, 2015.

Petitioner argues that it may not be held strictly liable for accidents.  P. Br. at 4.  Strict liability is not an issue in SNF enforcement cases such as this and there is no evidence that CMS is attempting to impose strict liability upon Petitioner for Resident 12’s injury.  The Act and regulations require that Petitioner maintain compliance with participation requirements to the extent that no violation poses a risk for more than minimal harm.  A violation without a risk for more than minimal harm does not expose Petitioner to an enforcement remedy.  Furthermore, when an accident happens and there is a risk for more than minimal harm, Petitioner is granted the opportunity to show it was in substantial compliance.  However, the Board has imposed upon Petitioner the burden to show it was in substantial compliance by a preponderance of the evidence.

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Petitioner argues that falls and accidents happen in nursing homes and even CMS recognizes that a facility cannot prevent every accident.  Petitioner argues that it satisfies the requirements of 42 C.F.R. § 483.25(h), if it assesses a resident and implements interventions to minimize accident risk.  Petitioner argues that the noncompliance alleged under Tag F323 involved a single resident and a single incident.  Petitioner argues it assessed Resident 12 as at risk for elopement and she was at no higher risk than any other resident in similar condition.  P. Br. at 4-5.  Petitioner fails to mention however, that according to its own policy and the elopement assessment form, the assessment of Resident 12 as at risk for elopement required the completion of a specific elopement care plan in a space provided on the back of the elopement assessment form.  CMS Ex. 12 at 102, 106; CMS Ex. 22 at 2.  The surveyors found no evidence that Petitioner ever completed a specific elopement care plan as its own policy and form required, and Petitioner has not offered any evidence that it did so.

Petitioner argues that even though the IDT or a qualified team completed no specific elopement care plan, there were interventions that addressed Resident 12’s assessed risk for elopement.  P. Br. at 5.  Resident 12 had an alarm on her wheel chair to alert staff if she attempt to get up, or I note, if she fell from the chair.  P. Br. at 5.  However, Petitioner does not explain how that chair alarm worked to prevent or minimize the risk of elopement or of accidental injury associated with elopement.  For example, how would staff hear the alarm if the resident fell from her chair while unsupervised and outdoors after eloping?  Petitioner conducted extensive in-service training regarding elopement prevention, redirection, wandering behaviors and related topics.  P. Br. at 5-6.  While the evidence supports the assertion that there was training, that training alone was clearly not sufficient to prevent elopement; the training had to be implemented to be an effective intervention and required supervision, redirection, misdirection, and other techniques to effectively prevent or reduce the risk for elopement.  Petitioner also relies upon redirection as an effective intervention.  P. Br. at 6-7.  However, nursing notes show that redirection was not effective on November 25, 2015, when the resident was exit seeking.  CMS Ex. 12 at 99.  Furthermore, redirection may only occur when staff are aware that a resident requires redirection.  On December 18, 2015, Resident 12’s elopement was unobserved and redirection could not be an effective intervention.  Petitioner argues that on December 18, 2015, Petitioner’s staff was performing visual checks on Resident 12 at least once per hour.  P. Exs. 15, 16.  Certainly, the evidence Petitioner cites shows that hourly checks were to be performed and staff recorded that Resident 12 was seen approximately every hour.  However, despite the checks, Resident 12 managed to slip out the unlocked door unobserved, demonstrating that the intervention of hourly checks was simply inadequate for Resident 12’s needs.  Although I accept that there were interventions in place under separate care plans created and implemented by Petitioner and hospice and other interventions not listed on care plans, the evidence does not show that the interventions were developed under the supervision of the IDT or a qualified team and implemented in an effective manner to specifically address the assessed risk for elopement and the resident’s exit‑seeking behavior.  Petitioner has the burden to show its

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interventions were effective.  Clearly Resident 12 did elope through an unlocked door and she was injured, establishing without doubt that prior interventions were not effective to prevent that elopement.

Petitioner argues that it was improper to cite it for noncompliance under Tag F323 because Petitioner’s Quality Assurance Committee (QA) was already addressing the issues identified in Tag F323 and the citation of deficiency was based in part upon QA documents.  P. Br. at 8-10.  Petitioner takes the position that its incident reports related to the elopement and the resident’s clinical records may not be considered to determine whether there was noncompliance because its QA committee was already addressing the problems.  Petitioner cites no authority that permits it to use its QA process to prevent a citation of noncompliance.  Pursuant to 42 C.F.R. § 483.13(c)(2) and (4), Petitioner was required to investigate the elopement of Resident 12.  Pursuant to 42 C.F.R. § 483.75(l), Petitioner was required to create and maintain clinical records for each resident.  The Tex. Health & Safety Code Ann. § 161.032 provides:

(f) This section and Subchapter A, Chapter 160, Occupations Code, do not apply to records made or maintained in the regular course of business by a hospital, health maintenance organization, medical organization, university medical center or health science center, hospital district, hospital authority, or extended care facility.

(Emphasis added.)  Petitioner’s argument that clinical records required to be maintained for each resident are subject to its claim of a quality assurance privilege is without merit.  Similarly, reports of investigations required by 42 C.F.R. § 483.13(c)(2) and (4) must be treated as being maintained in the regular course of business for a SNF or NF.  Therefore, those reports are not subject to any quality assurance privilege under Texas law.  The federal regulation requiring each facility to have a quality assurance committee provides that the state agency and Secretary may not require disclosure of the records of the quality assurance committee except to prove that the committee exists and operates in accordance with the regulation.  42 C.F.R. § 483.75(o)(3).  However, that regulation does not prevent disclosure of records required to be submitted to the state in accordance with 42 C.F.R. § 483.13(c)(2) and (4) related to the investigation or required to be maintained as a part of the clinical record of a resident.  In Jewish Home of Eastern Pa., DAB No. 2254 at 6 n.3 (2009), the Board commented that 42 C.F.R. § 483.75(o)(3) does not establish a privilege but rather a restriction on the use of quality assurance committee documents.  The Board looked at certain reports in that case and concluded that they were not in the nature of quality assurance committee records but, rather, were records created to meet the reporting requirements of 42 C.F.R. § 483.13(c)(2), (3), and (4).  Id. at 9-12.  The same may be said of the incident report and clinical records in this case.

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Petitioner argues that it was not cited for noncompliance related to care planning, resident assessments, neglect, policy development or implementation, or failure to notify a physician of a significant change.  P. Reply at 2-3.  I agree that the elopement of Resident 12 was only cited as noncompliance under Tag F323.13   Based on the citation of noncompliance, whether or not Resident 12 was adequately supervised is the key issue to be resolved.  However, the adequacy of the supervision provided to Resident 12 requires consideration of the various hazards and risks, such as the unmonitored and unlocked back door, the resident’s risk for falling, the resident’s physical and emotional status, including the existence of a UTI and recent death of her son, and her history of exit seeking, among other things mentioned in the findings of fact.  Petitioner argues it was not specifically cited because the unlocked door through which Resident 12 eloped was unlocked.  P. Reply at 2.  However, for reasons already discussed, the unmonitored and unlocked back door and what lay beyond constituted an accident hazard for Resident 12 that required mitigation in light of Resident 12’s wandering and exit‑seeking behavior.  Petitioner argues that its interventions listed in various care plans and nurse’s notes were adequate.  P. Reply at 3-6.  The fact that the level of supervision was not adequate is shown by the fact the resident eloped.  A significant challenge for Petitioner is that Petitioner can produce no evidence that Resident 12’s IDT considered the resident’s elopement risk assessments, including her changed behavior on November 25 and December 4, 2015, and developed a plan to address her needs for supervision to prevent elopement.  While any of the interventions devised on an ad hoc basis to address the resident’s needs for care and services, may have helped deter elopement, there is no evidence of deliberate planning and implementation of interventions to address the specific risk of elopement and need for supervision or other interventions to address the risk.  Petitioner has also presented no evidence that Petitioner actually assessed the risk posed by the unlocked back door for all its residents, including not only the risk for wandering but security risks, and considered appropriate interventions.  Supervision of residents was clearly a possible intervention, but monitoring access to the door, either visual monitoring or by an alarm system, was an obvious intervention Petitioner had not implemented that could have prevented Resident 12’s elopement.

Petitioner cites the testimony of Dr. Merritt in support of its position that it did all it needed to protect Resident 12.  P. Reply at 7-9.  Dr. Merritt is certainly well qualified to provide expert opinions regarding nursing home operation and resident care.  I accept Dr. Merritt’s opinions that Petitioner had implemented some appropriate interventions that applied to Resident 12’s assessed risk for elopement.  However, to the extent her testimony may be construed to indicate that there was nothing more that Petitioner could do, her testimony is not credible.  As already discussed, there is no evidence that the 

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resident’s IDT ever considered what interventions might be necessary to address Resident 12’s elopement risk.  The IDT and not Dr. Merritt, the state agency, or CMS, was in the best position to determine whether the resident required checks more frequently than hourly, a medication change, or some other intervention.  However, the IDT did not do its job and Dr. Merritt’s opinions do not remedy that defect.

I also conclude that CMS’s determination that the noncompliance under Tag F323 posed immediate jeopardy was not clearly erroneous.  The surveyors concluded that the immediate jeopardy was abated on February 19, 2016.  CMS Ex. 3 at 2, 22.  However, before me CMS states that the immediate jeopardy existed from November 25, 2015 through December 18, 2015.  Tr. 207, 281, 292; CMS Ex. 21 (CMP in the higher range proposed for November 25 through December 18, 2015).  Petitioner argues that the declaration of immediate jeopardy was clearly erroneous and the citation of a pattern of noncompliance is unsupported.  P. Br. at 11-13.

Petitioner bears a heavy burden under the regulations when challenging a declaration of immediate jeopardy.  Unlike the issue of whether there is noncompliance, the Secretary has by regulation imposed the burden of persuasion on Petitioner to show that the declaration of immediate jeopardy was in error not by a preponderance of the evidence, but by a showing that the declaration was clearly erroneous.  The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS’s determination 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, DAB No. 2384 at 14-15 (citing Liberty Commons, 241 F. App’x 76, at 80-81).

“Immediate jeopardy” under the regulations refers to “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. §§ 488.301, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced

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enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(ii).

Many appellate panels of the Board have addressed “immediate jeopardy.”14   In Mississippi Care Ctr. of Greenville, the Board commented:

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

DAB No. 2450 at 15 (2012).  The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and

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Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not 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 by adopting the clearly erroneous standard of review, the drafters of 42 C.F.R. § 498.60(c)(2) sought to ensure that the determination of immediate jeopardy by a state agency or CMS would receive deferential consideration.  Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Ctr., Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be

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read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving deference or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Center,that panel of the Board states that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  DAB No. 2450 at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Center and other cases does not define the standard.  The “clearly erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black’s Law Dictionary 269 (8th ed. 2004).  The United States Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedure Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring); Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consol. Edison Co. of New York v. N.L.R.B., 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires meaningful review.15   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 (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs., 453 F. App’x 610).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7-8.  There is a difference between “likelihood” as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences may be.  Woodstock Care Ctr., DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm?”  On the first question, the Board recognized in Yakima Valley School, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.16   DAB No. 2422 at 8. 

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The Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.”  Id. (citing Daughters of Miriam Ctr.,DAB No. 2067 at 9).  In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut 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 no definite and firm conviction that an error has been committed.  I conclude that Petitioner has failed to show that the declaration of immediate jeopardy was clearly erroneous.  Petitioner failed to provide necessary care and services for Resident 12.  Specifically, Petitioner failed to ensure that the demented Resident 12 who was prone to wander and was at risk for injury due to falls, was supervised so that she did not elope and fall on the parking lot sustaining injuries.  At the time of the survey, Petitioner identified six other residents at risk for elopement and/or wandering that could be affected by inadequate supervision and the unlocked back door.  CMS Ex. 3 at 13-14.  Furthermore, this noncompliance involved multiple staff members who failed to ensure that Resident 12 was adequately assessed, care planned, and supervised.  Petitioner has not shown that Resident 12’s elopement, fall, and injury were not serious under any reasonable definition of serious.

Petitioner argues that the scope and severity designation of immediate jeopardy is clearly erroneous and should be lowered.  Petitioner first argues that a “Level K citation should not stand because . . . this citation involves only one resident and one incident” which “is not enough to constitute a ‘pattern’ finding, particularly when no other residents were

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found to have been affected by the allegedly deficient practice.”  P. Br. at 11-13.  Multiple residents were at risk without adequate supervision and the involvement of several of Petitioner’s staff show that this was not simply an isolated incident involving one resident and one staff member.

Appendix Q of the SOM includes CMS guidance to surveyors on how to identify immediate jeopardy.  Petitioner urges me to consider that the surveyors did not strictly comply with SOM Appendix Q.  P. Br. at 12-13; P. Reply at 9-12.  Petitioner’s reliance on SOM Appendix Q is misplaced before me.  Appendix Q is a guide for surveyors in how to apply a regulatory standard; it does not define that standard nor is it enforceable as a regulation.  The regulations, not the SOM, are binding on ALJs and the Board.  Pinecrest Nursing & Rehab. Ctr., DAB No. 2446 at 18‑19 (2012).  While Appendix Q may be instructive on the issue of immediate jeopardy, it is not controlling authority.  Foxwood Springs Living Ctr., DAB No. 2294 at 9 (2009).  Petitioner cites no authority for its position that surveyor deviations from the guidance in Appendix Q, even if shown, are a basis to conclude that the declaration of immediate jeopardy is clearly erroneous.

Viewing the record as a whole, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the noncompliance cited under 42 C.F.R. § 483.25(h) (Tag F323) during the period November 25, 2015 through December 18, 2015 was clearly erroneous.

3.  Petitioner violated 42 C.F.R. § 483.25(l) (Tag F329) and the violation posed a risk for more than minimal harm.

The deficiency relates to an incident involving Resident 4.  The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.25(l) because Petitioner failed to ensure that Resident 4’s drug regime included no unnecessary drugs.  More specifically the surveyors alleged that Petitioner failed to document a specific clinical condition that supported the use of the antipsychotic medications Seroquel® and Risperdal®; and failed to identify behavioral or non-pharmacological interventions to address the resident’s behaviors.  The surveyors allege that both drugs had black box warnings indicating they pose an increased risk for death in the elderly.  The surveyors also allege that there was no record that a gradual dose reduction for the drugs was attempted.  CMS Ex. 3 at 22-27.

a.  Facts

Resident 4 was originally admitted to Petitioner’s facility on October 1, 2014 and readmitted on February 20, 2015.  She was 81 years old at the time of the survey.  CMS Ex. 11 at 6.  Her February 20, 2015 admission record listed diagnoses including:  essential hypertension; unspecified psychosis not due to a substance or known physiological condition; major depressive disorder, single episode; anxiety disorder; Alzheimer’s disease; and insomnia.  CMS Ex. 11 at 6-7, 57.  Upon her initial admission

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in 2014, Petitioner’s staff documented consent for Resident 4 to receive Seroquel® 25 mg to treat anxiety and agitation.  Staff noted that this proposed course of the medication was for prolonged treatment.  CMS Ex. 11 at 14.  Petitioner’s staff also documented consent for Resident 4 to receive risperidone (the generic form of Risperdal®) 0.5 mg for psychosis to improve her functioning and reduce adverse behaviors.  Again, staff noted that the course of the medication would be for prolonged treatment.  CMS Ex. 11 at 15.  A physician’s order dated February 20, 2015, when Resident 4 was readmitted to Petitioner’s facility, directed that Resident 4 receive Seroquel® 25 mg once per day to treat unspecified psychosis.  An April 27, 2015 order directs that she be given Risperdal® 0.5 mg due to unspecified psychosis.  CMS Ex. 11 at 60.

A plan of care for Resident 4 lists an onset date of January 25, 2015, for the problem for which the resident had an order for psychotropic medication.  The plan was updated in March, April, June, and July 2015.  The plan lists as interventions that Petitioner would obtain informed consent to administer the medication, and that staff would monitor Resident 4 and maintain behavior flow sheets.  CMS Ex. 11 at 64.  A plan of care, also with an onset date of January 25, 2015, was updated in March, April, June, and July 2015, and covers the problem of psychosocial wellbeing due to anxiety, depression, psychosis, and Alzheimer’s.  CMS Ex. 11 at 65.  Listed interventions include:  encourage interaction between family, resident, and refer Resident 4 to psychological services for evaluation and treatment of her ineffective coping skills; meet with the resident and her family quarterly and as needed; and refer Resident 4 to social services as needed.  CMS Ex. 11 at 65.  A January 25, 2015 care plan with an onset of January 25, 2015 and updated in March, April, June, and July 2015, addressed the problem that the resident was anxious.  Interventions listed included:  checks every two hours and as necessary; one-on-one with staff for redirection, comfort and reassurance as needed during times of increased anxiety and restlessness; encouraging socialization; reminding Resident 4 of activity times and encouraging attendance; encouraging family to visit; administering anti-anxiety medication as ordered and monitoring effectiveness; and referring the resident to social services as needed.  CMS Ex. 11 at 66.

An MDS with an assessment reference date of November 4, 2015, does not list a psychotic disorder as a diagnosis for Resident 4.  CMS Ex. 11 at 51.  No hallucinations or delusions were noted during the assessment period.  However, the MDS shows that Resident 4 was receiving antipsychotic medications during the assessment period.  CMS Ex. 11 at 53.  Resident 4 was in hospice care during the assessment period.  CMS Ex. 11 at 54.  An MDS with an assessment reference date of December 30, 2015, indicates that Resident 4 had a psychotic disorder and received antipsychotic medications.  CMS Ex. 11 at 22 34.  The MDS indicates that the resident had no hallucinations or delusions during the assessment period.  CMS Ex. 11 at 19.  Resident 4 was in hospice care at the time of the assessment.  CMS Ex. 11 at 34.

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Progress notes dated January 19, January 31, February 4, and February 5, 2016, show that drug interaction warnings were received related to Resident 4 receiving Seroquel® 25 mg and Risperdal® 0.5 mg.  CMS Ex. 11 at 24-27, 32, 63.

Weekly summaries dated January 8, 15, 22, and 29, 2016, show that Resident 4 was not experiencing delusions or hallucinations.  CMS Ex. 11 at 40-43.

DON Ashcraft testified that spoke with a surveyor about Resident 4 and her diagnoses that supported using psychotropic drugs.  She explained that the first day of the survey the computer was down and she had to pull the physical chart for the resident and that included the diagnoses.  The surveyor told her Petitioner was being cited under Tag F329 anyway.  Tr. 433-38.

b.  Analysis

The regulation provides: 

(l) Unnecessary drugs – (1) General.  Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used:

(i) In excessive dose (including duplicate drug therapy); or

(ii) For excessive duration; or

(iii) Without adequate monitoring; or

(iv) Without adequate indications for its use; or

(v) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or

(vi) Any combinations of the reasons above.

(2) Antipsychotic Drugs.  Based on a comprehensive assessment of a resident, the facility must ensure that—

(i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and

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(ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

42 C.F.R. § 483.25(l)(2).

The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.25(l) because Petitioner failed to ensure that Resident 4’s drug regime included no unnecessary drugs.  More specifically the surveyors alleged that Petitioner failed to:

Document a specific clinical condition that supported the use of the antipsychotic medications Seroquel and Risperdal;

Failed to identify behavioral or non-pharmacological interventions to address the resident’s behaviors and the surveyors also allege that there was no record that a gradual dose reduction for the drugs was attempted. 

The surveyors allege, and it is not disputed, that each drug had a black box warning indicating the drug posed an increased risk for death in the elderly.  CMS Ex. 3 at 22-27.

Contrary to the surveyor’s allegations, there is clear evidence that Resident 4’s clinical record reflected a clinical condition for which she was prescribed Risperdal® and Seroquel®.  Her records list a diagnosis of unspecified psychosis.  CMS Ex. 11 at 6-7, 57.  When admitted to Petitioner in 2014, Resident 4 was prescribed Seroquel® for anxiety and agitation.  CMS Ex. 11 at 14.  She was prescribed Risperdal® for psychosis.  CMS Ex. 11 at 15.  In February and April 2015, Resident 4’s physician prescribed both drugs to address the resident’s unspecified psychosis.  CMS Ex. 11 at 60.  Accordingly, I find there was a specific clinical condition documented for which Resident 4’s physician ordered Risperdal® and Seroquel® and Petitioner did not violate 42 C.F.R. § 483.25(l)(i).

However, CMS made a prima facie showing of a violation of 42 C.F.R. § 483.25(l)(ii).  CMS offered evidence collected from the clinical records of Petitioner for Resident 4.  Petitioner offered no additional evidence to supplement that offered by CMS.  Tr. 438.  There is no evidence that Petitioner ensured that the comprehensive assessment required by 42 C.F.R. § 483.25(l) was done and documented.  There is also no evidence that Petitioner attempted to meet the regulatory requirements to reduce the resident’s dose of either drug, or attempted behavioral interventions in an effort to reduce or eliminate the dose.  The fact that other care plans may have included interventions that would be helpful for addressing Resident 4’s psychosis, does not satisfy the requirement of 42 C.F.R. § 483.25(l)(ii) which requires specific efforts to reduce or eliminate the dose of the psychotropic medications.  Had such an effort been made, it should have been well

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documented in Petitioner’s records, particularly in light of the risk to Resident 4 and the potential liability of Petitioner and the resident’s prescribing physician.  Petitioner has also offered no competent medical evidence to rebut CMS’s prima facie case or show as a defense that attempting to reduce the dose would be clinically contraindicated.  Petitioner does not assert in either its post-hearing brief or its post-hearing reply brief that the requirements of 42 C.F.R. § 483.25(l) were met in the case of Resident 4.  P. Br. at 13-15; P. Reply.  Furthermore, it is undisputed that the black box warnings for each drug indicate that use in the elderly poses an increased risk for death, establishing that there was a risk for more than minimal harm to Resident 4 due to her continued use of the drugs.

4.  Petitioner violated 42 C.F.R. §§ 483.25(m)(2) (Tag F333) and 483.60(a) (Tag F425) and the violations posed a risk for more than minimal harm.

These two deficiencies are discussed together because they involve the same resident and facts.  The surveyors alleged under Tag F333 that Petitioner committed a significant medication error in the case of Resident 6 because staff failed to follow physician orders to hold the resident’s dose of Labetalol, a hypertension medicine, on the days Resident 6 received dialysis.  CMS Ex. 3 at 27-28.  The surveyors allege noncompliance under Tag F425 for the same reason.  CMS Ex. 3 at 33.

a.  Facts

Resident 6 was initially admitted to Petitioner’s facility on July 27, 2011, and was readmitted on June 3, 2015.  Her diagnoses included Alzheimer’s, dementia, general muscle weakness, abnormality of gait, lack of coordination, memory loss, type 2 diabetes, renal failure requiring dialysis, and a history of UTIs.  CMS Ex. 10 at 1-9, 46.  Resident 6’s physician issued an order on June 3, 2015, for one Labetalol HCL 100 mg (Labetalol) tablet by mouth every 12 hours, except the order specified that the medication was to be held prior to dialysis treatment on Monday and Friday, and also for a systolic blood pressure under 90 or a pulse under 60.  CMS Ex. 10 at 5.  Resident 6’s care plans initiated on August 1, 2015 and February 3, 2016, and an MDS with an assessment reference date of November 4, 2015 (CMS Ex. 10 at 36) show that Resident 6 received regular dialysis.  CMS Ex. 10 at 10, 17, 56.  Petitioner’s Medication Administration Records (MAR) for the months of December 2015 and January 2016 state that Resident 6’s dose of Labetalol was to be held prior to dialysis treatment on Monday and Friday.  The MARs show that Resident 6 was given Labetalol every day in December 2015 and January 2016 at 9:00 a.m., except on December 4, 2015.  CMS Ex. 10 at 19, 25.

The SOD alleges that the surveyors interviewed staff during the survey.  A licensed vocational nurse (LVN) told the surveyors that Resident 6 did not refuse to go to dialysis in December 2015 or January 2016.  However, the resident did not always go to dialysis

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on Monday and Friday.  The LVN told surveyors that she was unaware that the resident’s Labetalol was not being withheld prior to dialysis.  CMS Ex. 3 at 28-29, 33-34.  The SOD alleges that the staff member responsible for giving Resident 6 her medications told the surveyors that she gave Resident 6 her Labetalol every day at 9:00 a.m. and that she was not aware she was supposed to hold the Labetalol on days when Resident 6 received dialysis.  CMS Ex. 3 at 29, 34.  The physician’s order, as recorded in the MAR, was to hold Labetalol prior to dialysis, not to withhold Labetalol for the entire day on which the resident received dialysis.  CMS Ex. 10 at 24-25.  It is not clear whether the held Labetalol was to be administered after dialysis or whether the dose held prior to dialysis was to be missed.  Furthermore, it is not alleged in the SOD and the evidence does not show when Resident 6 actually went to dialysis.  Therefore, no inference can be made that she went to dialysis and returned before 9:00 a.m. so that her Labetalol administered at 9:00 a.m. was after she completed her dialysis.

The surveyors allege in the SOD citing the website “Drugs.com” that Labetalol can cause a “severe potential hazard” if used while a patient is also on hemodialysis and that it should be “administered cautiously.”  CMS Ex. 3 at 29-30.  Further, anyone taking the medication after dialysis should be monitored to ensure no marked falls in blood pressure before or after the dose.  CMS Ex. 3 at 30.

b.  Tag F333 Analysis

Long-term care facilities participating in Medicare must ensure that each resident is provided and receives “the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the [resident’s] comprehensive assessment and plan of care.”  42 C.F.R. § 483.25.  Regarding medication errors, the quality of care regulations require that the facility must ensure that:

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

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

42 C.F.R. § 483.25(m).  There is no allegation in this case that Petitioner had a medication error rate of five percent or more. 

According to the SOM, app. PP, Tag F333 (rev. 41, eff. Apr. 10, 2009), a medication error is the “observed preparation or administration of drugs or biologicals” not in accordance with:  physician’s orders, manufacturer’s specification, or accepted professional standards and principles applicable to the professional preparing or administering the drug or biological.  A significant medication error is one that causes a resident discomfort or jeopardizes his or her health or safety.  The term “jeopardizes” is

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not defined in the SOM.  The common meaning of “jeopardize” is “to expose to danger or risk” or to “imperil.”17

The Board has stated that it is not necessary for CMS to show that there was any actual harm to support a conclusion that a medication error is significant.  Rather, a medication error may be significant if there is a potential danger or risk to a resident’s health and safety.  Life Care Ctr. of Tullahoma, DAB No. 2304 at 35 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sebelius,453 F. App’x 610 (6th Cir. 2011).  Discomfort may depend upon the individual resident.  The relative significance of medication errors is a matter of professional judgment that considers three factors:  (1) resident condition; (2) drug category; and (3) frequency of the error.  Id. at 36 (citing 56 Fed. Reg. 48,853 (Sep. 26, 1991)).  The SOM includes a list of medication errors and characterizes them as significant or non-significant.  Labetalol is not listed.  Thus, there is no presumption that a medication error related to the administration of Labetalol is either significant or non‑significant.  SOM, app. PP, Tag F333.

In order to make a prima facie showing of noncompliance under Tag F333 based on a violation of 42 C.F.R. § 483.25(m)(2), CMS must show that: 

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

(2) The medication error was significant because it;

(i) Caused Resident 6 discomfort, or

(ii) Jeopardized her health; and

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

Resident 6’s physician ordered that she not receive Labetalol prior to dialysis on Monday and Friday.  CMS Ex. 10 at 19, 25.  The CMS evidence shows that a medication error occurred because:

Labetalol was administered every day in December 2015 and January 2016, except December 4, 2015 (CMS Ex. 10 at 19, 25);

Resident 6 did not refuse dialysis in December 2015 and January 2016 (CMS Ex. 3 at 28-29, 33-34); and

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Administration of Labetalol on days the resident had dialysis violated the physician’s orders.

CMS’s evidence, including the physician’s order to withhold Labetalol prior to dialysis and the surveyors’ opinions alleged in the SOD based on their review of information on Drugs.com, shows that administration of Labetalol for Resident 6 prior to undergoing dialysis jeopardized the resident’s health.  CMS Ex. 3 at 29-30.  Also, the evidence shows that the resident should have received dialysis two days per week.  Therefore, it can be inferred that the medication error occurred as many as 16 times in December 2015 and January 2016.  CMS Ex. 10 at 19, 25.

Accordingly, I conclude that CMS made a prima facie showing of noncompliance under Tag F333.  Petitioner bears the burden to rebut the prima facie showing or to establish an affirmative defense.

Petitioner does not deny that Resident 6 received Labetalol prior to dialysis in violation of the physician’s orders.  Petitioner does not deny medication errors occurred.  P. Br. at 16 n.2.  Rather, Petitioner addresses the second element of CMS’s prima facie case arguing that Resident 6 suffered no discomfort and her health was not jeopardized due to the medication error.  P. Br. at 16-17.  Petitioner argues that the Drugs.com information upon which the surveyors based their opinion refers to risk secondary to administering Labetalol after dialysis not before.  CMS made a prima facie showing based on the physician’s order and the surveyors’ opinions based on information they found on Drugs.com.  The burden therefore shifted to Petitioner to show by a preponderance of the evidence that there was no jeopardy to Resident 6’s health.  In this case, Petitioner cannot meet its burden without some evidence to show that there was no risk to Resident 6’s health.  Petitioner did not offer evidence, only argument.

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(m)(2) and that the violation posed a risk for more than minimal harm, and Petitioner has failed to rebut the prima facie showing of noncompliance.

c.  Tag F425 Analysis

The facility must provide routine and emergency drugs to its residents or obtain them under an agreement.  Unlicensed facility personnel may administer drugs if state law permits, but only under the general supervision of a licensed nurse.  42 C.F.R. § 483.60. 
The regulation requires that a facility provide pharmaceutical services that meet the needs of each resident.  Pharmaceutical services must include procedures to ensure accurate acquisition, receipt, dispensing, and administration of pharmaceuticals.  42 C.F.R. § 483.60(a).  The regulation also requires that the facility employ or obtain the services of a licensed pharmacist who consults on all aspects of pharmacy services at the facility; establishes a system of records for the receipt and disposition of controlled substances;

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and ensures drug records are in order and that all controlled drugs can be accounted for periodically.  42 C.F.R. § 483.60(b).

The surveyors allege that Petitioner violated 42 C.F.R. § 483.60(a) and (b).  However, there are no allegations in the SOD under Tag F425 that Petitioner failed to have the required pharmacist services under 42 C.F.R. § 483.60(b).  Rather, the surveyors allege only a violation of 42 C.F.R. § 483.60(a), based on the same facts set forth under Tag F333 related to Resident 6.  The surveyors allege that Petitioner failed to provide pharmacy services for Resident 6 that were accurate in the dispensing and administration of Labetalol.  CMS Ex. 3 at 32-33.

The CMS prima facie showing under Tag F425 is satisfied by the prima facie showing under Tag F333.  Petitioner has not disputed that medication errors occurred in the case of Resident 6, or that the errors occurred multiple times.  P. Br. at 16-18.  Clearly, the dispensing and administration of Labetalol to Resident 6 prior to receiving dialysis violated her physician’s orders and constituted a medication error.  For the reasons discussed under Tag F333, I find that the medication error was significant and posed a risk for more than minimal harm to Resident 6.  Accordingly, I conclude that CMS made a prima facie showing of noncompliance under Tag F425.

Petitioner argues that the surveyors admit that Petitioner had proper procedures and policies in place to ensure medications were administered appropriately and in accordance with physicians’ orders.  Petitioner also argues that its system was working and effective because most residents received accurate medications.  P. Br. at 18.  My reading of the SOD differs from that of Petitioner.  In fact, the SOD is clear that the surveyors found that Resident 6 was administered Labetalol on multiple occasions prior to dialysis, in direct contravention of her doctor’s orders.  Furthermore, the nurse responsible for administering the medication admitted that she was unaware of the well-documented physician order that the medication be held prior to dialysis.  CMS Ex. 3 at 33-35.  Therefore, the SOD clearly alleges that the system Petitioner had for dispensing and administering drugs failed in the case of Resident 6 and showed the possibility for failure in the case of 58 other residents, even though the surveyors found no other medication errors that they cited during the February 2016 survey.  Petitioner presented no testimony of Resident 6’s physician or any scientific evidence to rebut CMS’s evidence that Resident 6’s health was placed in jeopardy by the repeated medication error in her case.

Accordingly, I conclude that Petitioner violated 42 C.F.R. § 483.60(a) and the violation posed a risk for more than minimal harm.  Petitioner has failed to rebut the prima facie showing by CMS.

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5.  Petitioner violated 42 C.F.R. § 483.35(d)(1)‑(2) (Tag F364) and the violation posed a risk for more than minimal harm.

The regulations require that facilities ensure that

Each resident receives and the facility provides –

(1) Food prepared by methods that conserve nutritive value, flavor, and appearance;

(2) Food that is palatable, attractive, and at the proper temperature. 

42 C.F.R. § 483.35(d)(1)-(2).  The surveyors allege that Petitioner violated the regulation because Petitioner failed to ensure hot breakfast food was served at the proper temperature for seven of thirteen residents.  The surveyors allege that the risk for residents was “decreased meal satisfaction, decreased intake, loss of appetite, and weight loss.”  CMS Ex. 3 at 31.

The surveyors conducted a confidential group interview with 13 residents, seven of whom complained that hot foods were served cold.  The surveyors observed the breakfast meal on February 4, 2016.  A meal cart left the kitchen at 7:12 a.m. with the last tray delivered at 7:30 a.m.  Food items tasted at 7:30 a.m. including scrambled eggs, waffle, and sausage were cold.  The food cart was not covered and plate warmers were not used.  The last tray delivered in the dining room at 7:40 a.m., was also tasted and the sausage/gravy, fried eggs, waffle, and cream of wheat were cold.  There is no indication that the surveyors used a thermometer to measure temperature but rather relied upon their own tasting of the food.  CMS Ex. 3 at 32-33.

The surveyor also noted that Petitioner’s Dining Room Service policy requires prompt distribution of meals to maintain adequate temperature and appearance.  CMS Ex. 3 at 32.

Petitioner contends that the facility and its dietician have routinely taken resident satisfaction surveys related to food quality and palatability and that there have not been consistent complaints about food being cold.  I infer based on the phraseology used by Petitioner that there were some complaints that food was served cold.  Petitioner asserts that during the February 2016 resident council meeting there were no complaints that food that was supposed to be hot was served cold.  Petitioner also asserts based on the testimony of DON Ashcraft that the surveyors could not have determined that food was not served at the proper temperature because they did not use a thermometer to test the food temperature.  Finally, Petitioner argues that it conducted satisfaction surveys prior to

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and after the state survey and no issues were identified with food palatability or temperature.  P. Br. at 17.

DON Ashcraft testified that she did not see the surveyors actually take the temperature of the food they tasted.  She also testified that the surveyor took a tray to taste from the bottom of the tray rack, which would have been sitting the longest.  Tr. 440-41.  DON Ashcraft did not testify or rebut the statement of the surveyor in the SOD that the last trays served off the tray rack and in the dining room were tasted by the surveyor and that the surveyor determined that the food on the trays that was supposed to be hot was cold.  Petitioner points to no requirement that a thermometer be used to test temperatures or that temperatures must be taken when food is first plated and/or sent out for service to residents.  DON Ashcraft did not testify that she actually tasted the same trays tasted by the surveyors.  Petitioner presented no evidence about food palatability or temperature surveys completed by residents or the minutes of the February 2016 resident council meeting.  Petitioner also presented no evidence of regular testing of food temperatures before, during, or after food service.  The fact that Petitioner may have received few or no complaints about food temperature is outweighed by the evidence that residents did complain during the confidential survey conducted by the surveyors.  I also find weighty the surveyors’ opinions that serving food cold that is supposed to be hot poses a risk for more than minimal harm due to decreased satisfaction and appetite with decreased intake and weight loss.

I conclude that CMS has established a prima facie case that Petitioner was not in compliance with 42 C.F.R. § 483.35(d)(1)‑(2).  I further conclude that Petitioner has not rebutted the CMS prima facie case by a preponderance of the evidence.

6.  A CMP of $6,550 per day from November 25 through December 18, 2015, $1,100 per day from December 19, 2015 through February 19, 2016, and $200 per day from February 20 through March 17, 2016, for a total CMP of $231,900 is a reasonable enforcement remedy.

I have concluded that Petitioner violated 42 C.F.R. §§ 483.25(h) (Tag F323), 483.25(l) (Tag F329), 483.25(m)(2) (Tag F333), 483.60(a) (Tag F425), and 483.35(d)(1)-(2) (Tag F364).  Based on the regulatory violations, Petitioner was not in substantial compliance with program participation requirements from November 25, 2015 through March 17, 2016.  The violation of 42 C.F.R. § 483.25(h) (Tag F323) caused actual harm to Resident 12.  I have also concluded that the declaration of immediate jeopardy from November 25, 2015 through December 18, 2015, related to the noncompliance under Tag F323 was not clearly erroneous.  Further, Petitioner did not request ALJ review of the 11 alleged violations of the Life Safety Code under 42 C.F.R. § 483.70(a) and those violations are final and binding upon Petitioner and a basis for imposing a CMP.

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

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.  The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual 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.  Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14-16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

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CMS proposes a CMP totaling $231,900 as follows:

$6,550 per day for 24 days beginning November 25, 2015 and continuing through December 18, 2015;

$1,100 per day for 63 days beginning December 19, 2015 and continuing through February 19, 2016; and

$200 per day for 27 days beginning February 20, 2016 and continuing through March 17, 2016.

The undisputed Life Safety Code violations support a CMP in the lower range of CMPs.

I conclude that the $6,550 per day CMP proposed for the period of immediate jeopardy is reasonable based on my consideration of the regulatory factors.  A CMP of $6,550 for the period of immediate jeopardy is slightly above the middle of the authorized range of a CMP that may be imposed for noncompliance that poses immediate jeopardy.  Petitioner has a history of noncompliance having been previously cited by a survey in March 2015 for an elopement of a resident and that noncompliance also posed immediate jeopardy.  Tr. 295.  Petitioner has offered no evidence that its financial condition is such that the CMP cannot be paid.  The noncompliance under Tag F323 involving Resident 12 was very serious and resulted in actual harm to Resident 12.  Resident 12’s accident would likely not have happened if Petitioner had taken proper precautions to prevent her injury and to prevent her elopement by securing an unlocked, unsupervised door that Petitioner knew was unlocked and posed a risk for elopement of exit‑seeking residents.  Petitioner was highly culpable for the noncompliance under Tag F323 for neglecting to assess and remedy the unlocked door as a possible route for elopement.  Petitioner’s failure to identify the unlocked door as a possible elopement route and potential accident hazard placed multiple residents at risk for elopement and related accidental injury.  Petitioner’s noncompliance under Tags F333 and F425 resulted in multiple medication errors affecting Resident 6.  Under Tag 329, Petitioner’s noncompliance resulted in Resident 4 receiving possibly unnecessary psychotropic medications.  Petitioner’s noncompliance under Tags F329, F333, and F425 is serious even though the surveyors identified no actual harm.  Petitioner is culpable for the noncompliance because Petitioner neglected to ensure that the residents received only medications necessary and as prescribed.  I also consider the scope and severity of each Tag.

Petitioner argues that a total CMP of $231,900 is not reasonable.  Petitioner argues that no resident was harmed.  P. Br. at 18-19; P. Reply at 12.  Petitioner overlooks the serious injuries that Resident 12 suffered when she fell on Petitioner’s parking lot in the process of eloping.  Petitioner also argues that CMS did not properly consider or apply the factors established by 42 C.F.R. §§ 488.438 and 488.404.  P. Br. at 19; P. Reply at 12-13.  My review of the reasonableness of the remedies is de novo applying the factors established

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by 42 C.F.R. §§ 488.438 and 488.404.  I do not review whether or not CMS properly considered the factors specified by the regulations.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from November 25 through March 17, 2016.  I also conclude that a CMP of $6,550 per day from November 25 through December 18, 2015, $1,100 per day from December 19, 2015 through February 19, 2016, and $200 per day from February 20 through March 17, 2016, a total CMP of $231,900, is a reasonable enforcement remedy.

1. Citations are to the 2015 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the survey, unless otherwise indicated.
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2. This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), Appendix PP – Guidance to Surveyors for Long Term Care Facilities (http://www.cms.hhs.gov/Manuals/IOM/list.asp).  The “Tag” refers to the specific regulatory provision allegedly violated and CMS policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations as interpreted in the SOM clearly do have such force and effect.  Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary of Health and Human Services (Secretary) may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
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3. 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 not considered “noncompliance,” and which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L indicate deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and which are optional at each level based upon the frequency of the deficiency.
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4. CMS withdrew CMS Ex. 9 and it is not considered as evidence. Tr. 36 38.
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5. Petitioner initially offered P. Exs. 1 through 24 but clarified at the hearing that it did not submit P. Exs. 23 and 24 because they were duplicative of CMS’s exhibits.  Tr. 38. Petitioner also withdrew P. Exs. 1 through 10 during the hearing because CMS was no longer proceeding upon the alleged noncompliance to which those exhibits related.  Tr. 38-39.
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6. 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.
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7. Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act (42 U.S.C. § 1320a-7a).  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 (42 U.S.C. § 405) 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.
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8. “Credible evidence” is evidence that is worthy of belief.  Black’s Law Dictionary 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
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9. There is a care plan in evidence for wandering but the date initiated on that form is February 3, 2016.  CMS Ex. 12 at 112.  There is also a care plan dated January 13, 2016, that lists elopement and wandering but no goals or interventions are listed.  CMS Ex. 12 at 113.  Both care plans are dated after Resident 12’s exit‑seeking behavior on December 4, 2015, and her elopement and fall on December 18, 2015.  Petitioner placed in evidence a care plan that lists elopement and wandering risks.  However, the date initiated is January 13, 2016, and the interventions listed on this plan are all dated February 16, 2016 – also after the date of the resident’s elopement and fall on December 18, 2015.  P. Ex. 11 at 1.
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10. Petitioner was clearly on notice that the adequacy of the care plan is at issue in this case.
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11. Strict liability is generally considered to be “[l]iability that does not depend upon actual negligence or intent to harm, but that is based on the breach of an absolute duty to make something safe.”  Black’s Law Dictionary 934 (8th ed. 2004).  Black’s explains that strict liability is most often an issue in cases involving ultra‑hazardous activities or product liability.  Strict liability and absolute liability are synonymous.  The term liability simply means that one is legally obligated, accountable, or responsible to another or society.  Id. at 932.
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12. The regulation does not specify that the qualified team must be the IDT.  Rather, a SNF has discretion to assess the resident’s needs and interventions necessary to meet those needs using whatever qualified staff and professionals are necessary to best meet the resident’s needs.
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13. I render no opinion as to whether CMS could have cited multiple deficiencies based on the facts related to Resident 12.
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14. 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; Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726 at 39.
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15. 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 caution about ensuring meaningful review rather than rubber-stamping agency decisions show it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.
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16. Appendix Q of the SOM in effect at the time of the survey in this case failed to provide surveyors a working definition of the term “serious” that they could use to determine whether harm, injury, or impairment is serious when deciding whether or not to declare immediate jeopardy.  The Act does not define the phrase “immediately jeopardize” and does not introduce the concept of serious harm, injury, or impairment as the basis for finding immediate jeopardy.  Thus, one is not incorrect in concluding that absent a definition of the term “serious” in the Act, the regulations, the SOM, or decisions of the Board, it was up to individual surveyors and whatever unpublished guidance they received from their superiors or CMS officials, to exercise their individual discretion and judgment to decide that there was immediate jeopardy, which subjects a facility to the maximum imposable CMPs.
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17. Merriam-Webster, www.merriam-webster.com/dictionary (last visited May 26, 2020).
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