Pennsylvania Nursing and Rehabilitation Center, DAB CR5854 (2021)

DECISION

Petitioner, Pennsylvania Nursing and Rehabilitation Center, was not in substantial compliance with program participation requirements from February 16 through May 15, 2017.  Petitioner was not in substantial compliance due to violations of 42 C.F.R. §§ 483.12, 483.12(b), and 483.25,1 and those violations posed immediate jeopardy. 

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Petitioner also violated 42 C.F.R. § 483.25(d)(2), and that violation caused actual harm that did not amount to immediate jeopardy.  There is a basis for the imposition of enforcement remedies.  The following enforcement remedies are reasonable:  a civil money penalty (CMP) of $14,659 per day from February 16 through 24, 2017, and a CMP of $1,460 per day from February 25 through May 15, 2017.

I.  Background

Petitioner is located in Fort Worth, Texas, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint Stipulations (Jt. Stip.) at 2; Centers for Medicare & Medicaid Services (CMS) Exs. 1, 5.  On April 26, 2017, the Texas Department of Aging and Disability Services (state agency) completed a complaint investigation of Petitioner and found Petitioner was not in substantial compliance with program participation requirements.  Jt. Stip. at 2; CMS Exs. 1-3. 

CMS notified Petitioner of its initial determination by letter dated May 23, 2017.  CMS advised Petitioner that it concurred with the state agency findings of noncompliance and that it was imposing the following enforcement remedies:  mandatory termination of Petitioner’s provider agreement effective October 26, 2017, if Petitioner did not return to substantial compliance prior to that date; a CMP of $14,659 per day for nine days effective February 16 through 24, 2017 and a CMP of $1,460 per day effective February 25, 2017, and continuing until further notice from CMS; and denial of payment for new admissions (DPNA) effective May 25, 2017, until Petitioner achieved substantial compliance or its provider agreement was terminated.  CMS Ex. 1 at 1-3. 

CMS notified Petitioner by letter dated August 10, 2017, that Petitioner achieved substantial compliance with Medicare participation requirements effective May 16, 2017.  CMS advised Petitioner that the proposed termination and DPNA were rescinded and that it imposed a CMP of $14,659 per day for nine days from February 16 through 24, 2017

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(totaling $131,931), and a CMP of $1,460 per day for 80 days from February 25 through May 15, 2017 (totaling $116,800), for a total CMP of $248,731.  CMS Ex. 2. 

Petitioner requested a hearing before an administrative law judge (ALJ) on July 24, 2017 (RFH).  The case was assigned to me for hearing and decision on August 2, 2017, and an Acknowledgment and Prehearing Order was issued at my direction. 

On September 18 through 20, 2018, a hearing was convened by video teleconference, and a transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 29.  CMS Exs. 1 through 27 and 29 were admitted.  Tr. at 23-41.  Petitioner offered Petitioner exhibits (P. Exs.) 1 through 25 that were all admitted as evidence.  Tr. at 42-44.  CMS called the following witnesses:  former state surveyor and investigator Candace Amanchuku; and Captain (Public Health Service retired) Daniel J. McElroy, R.N.  Petitioner called the following witnesses:  Robert Parker, M.D.; Marie Lawson, Petitioner’s Administrator; and Pearl Merritt, R.N., Ed.D.

Following the hearing, the parties filed post-hearing briefs (CMS Br. and P. Br., respectively) and post-hearing reply briefs (CMS Reply and P. Reply, respectively).

II.  Discussion

A.  Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and at 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.2  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of the date noncompliance began.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of the date the facility is found to be out of compliance – commonly

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referred to as the mandatory or statutory DPNA.  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than 180 days of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and other remedies such as a directed plan of correction.  Act § 1819(h)(2)(B).

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

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10-.28, 488.300-.335. 

The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.  CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,394 to $20,965 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents, and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table).  “Immediate jeopardy means a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301 (emphasis in original).  The lower range of CMPs, $105 to $6,289 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table).

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The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1), 488.330(e), 498.3(b)(13).  However, the choice of enforcement remedies or the factors CMS considered when choosing enforcement remedies are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program (NATCEP).  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2); Woodstock Care Ctr., DAB No. 1726 at 9, 39 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e). 

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 the regulations.3  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 a prima facie case of noncompliance with a regulatory requirement.”  Evergreene Nursing,DAB No. 2069; 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.

B.  Issues

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

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Whether the declaration of immediate jeopardy was clearly erroneous, and

Whether the remedies proposed are reasonable.

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

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, although not all may be specifically discussed in this decision.  I discuss the credible evidence given the greatest weight in my decision-making. 4  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

Before proceeding with an analysis of the alleged noncompliance, it is necessary to correctly identify what is and is not alleged by the surveyors in the Statement of Deficiencies (SOD) (CMS Ex. 3) and identify the alleged noncompliance on which CMS proceeds before me.5

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The following table summarizes the surveyors’ allegations of noncompliance in the SOD.

F-TAG CITED	REGULATORY VIOLATIONS ALLEGED	S/S	CMS EX. 3 AT
F223	42 C.F.R. § 483.12(a)(1)	K	1-19
F226	42 C.F.R. §§ 483.12(b)(1)-(3), 483.95(c)(1)-(3)	K	19-37
F309	42 C.F.R. §§ 483.24, 483.25(k)(1)	K	37-55
F323	42 C.F.R. § 483.25(d)(1)-(2), (n)(1)-(3)	G	55-62

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Under Tag F223, the surveyors allege that Petitioner failed to ensure that Resident 2 was not neglected.  CMS Ex. 3 at 1.  The regulation cited by the surveyors in the SOD, 42 C.F.R. § 483.12(a)(1), is related specifically to a resident’s right to be free from abuse of any kind, corporal punishment, or involuntary seclusion.  The right to be free from neglect is actually found in 42 C.F.R. § 483.12, rather than one of its subsections.  Therefore, the correct regulatory citation for this alleged noncompliance is 42 C.F.R. § 483.12.  The surveyors’ incorrect regulatory citation did not prevent Petitioner from preparing to defend the allegation that Resident 2 was neglected, and that charge is clearly alleged.  CMS Ex. 3 at 1-2.  I conclude the error caused no prejudice.

Under Tag F226, the surveyors allege that Petitioner failed to implement its written policies and procedures which prohibited neglect of a resident.  CMS Ex. 3 at 20.  The requirement for such policies and procedures is established by 42 C.F.R. § 483.12(b).  The surveyors also cite violation of 42 C.F.R. § 483.95(c), which establishes the requirement to train staff related to abuse, neglect, exploitation, and misappropriation of resident property.  CMS Ex. 3 at 19.  The surveyors do not specifically allege that Petitioner failed to ensure staff received the training required by 42 C.F.R. § 483.95(c).  CMS Ex. 3 at 19-20.  Further, I conclude that Petitioner violated 42 C.F.R. § 483.12(b), which substantiates the alleged noncompliance described under Tag F226, and it is unnecessary to also find that Petitioner violated 42 C.F.R. § 483.95(c).  In its post‑hearing brief, CMS cites 42 C.F.R. § 483.12(c) as the regulation at issue under Tag F226.  CMS Br. at 12-15.  However, 42 C.F.R. § 483.12(c) establishes requirements for investigating, protecting a resident during an investigation, and reporting requirements for an allegation of abuse, neglect, exploitation, or mistreatment of a resident.  It is clear from the CMS brief that CMS intended to cite 42 C.F.R. § 483.12(b) as the regulation at issue and the citations to 42 C.F.R. § 483.12(c) in the CMS brief are merely scrivener’s errors that cause no prejudice.

Under Tag F309, the surveyors allege that Petitioner failed to ensure Resident 2 received “treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident[’s] choices.” CMS Ex. 3 at 38.  The surveyors allege violations of 42 C.F.R. §§ 483.24 and 483.25(k)(1).  CMS Ex. 3 at 37.  There is no subsection 483.25(k)(1) – 42 C.F.R. § 483.25(k) is related to pain management and 42 C.F.R. § 483.25(l) is related to dialysis.  The surveyors do not specifically allege a violation of either 42 C.F.R. § 483.25(k) or (l).  CMS Ex. 3 at 28.  Therefore, the citations to 42 C.F.R. § 483.25(k) and (l) are considered surplusage and not considered further.  The requirement of 42 C.F.R. § 483.24 is to provide necessary care and services for a resident to “attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care.”  CMS Ex. 3 at 37; 42 C.F.R. § 483.24.  The requirement of 483.25 is that a resident “receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents’

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choices . . . .”  The noncompliance alleged by the surveyors most closely tracks the language of the requirement of 42 C.F.R. § 483.25.  Therefore, I consider whether there was a violation of 42 C.F.R. § 483.25, rather than 42 C.F.R. § 483.24. 

Tags F223, F226, and F309 are analyzed together because they all arise from the allegations that Resident 2 did not receive necessary care and services; and was, therefore neglected; and the fact Resident 2 was neglected shows that Petitioner failed to implement its policies and procedures prohibiting neglect. 

Under Tag F323, the surveyors allege that Petitioner failed to ensure that Resident 1 received adequate assistance to prevent accidents.  CMS Ex. 3 at 55-56.  The surveyors allege that Petitioner’s failure is a violation of 42 C.F.R. § 483.25(d)(1)-(2) and (n)(1)‑(3).  CMS Ex. 3 at 55.  Petitioner is required to ensure that “[t]he resident environment remains as free of accident hazards as is possible.”  42 C.F.R. § 483.25(d)(1).  Petitioner is also required to ensure that “[e]ach resident receives adequate supervision and assistance devices to prevent accidents.”  42 C.F.R. § 483.25(d)(2).  Petitioner argued at the hearing and in briefs that the surveyors did not actually allege a violation of 42 C.F.R. § 483.25(d)(1).  Tr. 29-41; P. Br. at 25; P. Reply at 9-10.  The surveyors are very clear in the SOD as to the basis for the allegation of noncompliance under Tag F323, i.e., Petitioner “failed to ensure each resident received adequate assistance to prevent accidents for” Resident 1 “who required staff assistance with transfers.”  CMS Ex. 3 at 56-57.  The surveyors did not allege that Petitioner failed to ensure the resident environment was as free of accident hazards, such as defective slings on lifts, as possible.  Pursuant to 42 C.F.R. § 498.30, CMS had 12 months, i.e., until May 22, 2018, to reopen and revise its May 23, 2017 initial determination (CMS Ex. 1) and properly notify Petitioner that CMS concluded Petitioner also violated 42 C.F.R. § 483.25(d)(1), but CMS failed to do so.  Therefore, an alleged violation of 42 C.F.R. § 483.25(d)(1) is not considered further.  The surveyors also cite 42 C.F.R. § 483.25(n) under Tag F323, but that regulation has to do with bed rails.  There are no allegations related to bed rails in this case and no allegations by CMS related to the violation of this regulation.  Therefore, the citation to 42 C.F.R. § 483.25(n) is treated as surplusage and not considered further.

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

CMS made a prima facie showing that Petitioner violated the following regulatory participation requirements under the F-Tags cited by the surveyors, and that each violation posed a risk for minimal harm:

F‑TAG	RESIDENT	REGULATION VIOLATED
F223	2	42 C.F.R. § 483.12
F226	2	42 C.F.R. § 483.12(b)
F309	2	42 C.F.R. § 483.25

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F‑TAG	RESIDENT	REGULATION VIOLATED
F323	1	42 C.F.R. § 483.25(d)(2)

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

Petitioner has not shown that the declaration of immediate jeopardy and the duration of immediate jeopardy is clearly erroneous for the noncompliance under Tags F223, F226, and F309.

The proposed enforcement remedies are reasonable.

1.  Petitioner violated 42 C.F.R. § 483.12 as alleged under Tag F223.

2.  The violation of 42 C.F.R. § 483.12 posed a risk for more than minimal harm.

3.  Petitioner violated 42 C.F.R. § 483.12(b) as alleged under Tag F226.

4.  The violation of 42 C.F.R. § 483.12(b) posed a risk for more than minimal harm.

5.  Petitioner violated 42 C.F.R. § 483.25 as alleged under Tag F309.

6.  The violation of 42 C.F.R. § 483.25 posed a risk for more than minimal harm.

a.  Facts

(i)  Resident 2

Resident 2, a male, was 51 years old in February 2017, when the events described in the SOD occurred.  He was admitted to Petitioner on February 1, 2012.  CMS Ex. 13 at 1, 24-25.  Resident 2’s diagnoses included:  paraplegia, hemiplegia, traumatic brain injury, seizure disorder or epilepsy, hypertension, respiratory failure, bladder disorder, asthma, anemia, delusional disorders, major depression, gastro-esophageal reflux disease (GERD), hypothyroidism, hypokalemia, unspecified dementia, and unspecified psychosis.  CMS Ex. 13 at 1, 40-41. 

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Resident 2’s Minimum Data Set (MDS) assessment,6 with an assessment reference date of December 2, 2016, shows that with the exception of eating, he was totally dependent on staff for all activities of daily living (ADLs).  During the assessment period he did not walk or move about his room or the corridor, but he did have a wheelchair.  CMS Ex. 13 at 26, 33-34.  The MDS shows that Resident 2 was always incontinent of bowel and bladder.  At the time of the assessment, he was not on a toileting program.  CMS Ex. 13 at 39.

Resident 2’s comprehensive care plan dated December 15, 2016, states that he had a history of constipation and was at risk for impaction and bowel obstruction (bowel care plan).  The bowel care plan states the goal that Resident 2 have a bowel movement at least every three days.  Interventions listed required that staff:  monitor Resident 2 for possible causes of constipation and report to the resident’s physician; monitor his bowel movements including amount and consistency; and if he had no bowel movement for three days a bowel assessment was to be done and abnormal findings were to be reported to the resident’s physician.  Undated interventions listed on the care plan were to give the resident Colace® and MiraLax® daily.  P. Ex. 1 at 2; CMS Ex. 13 at 67.  A medication review report shows that Resident 2’s prescriptions for the two laxatives dated at least back to January 29, 2017.  CMS Ex. 13 at 106.  His care plan showed that he was totally dependent on one to two staff for toileting.  CMS Ex. 13 at 68. 

On January 4, 2017, Resident 2 was examined by his physician, A. Ray Lewis.  In his progress note, Dr. Lewis indicated, among other things, that Resident 2’s abdomen was

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soft, not tender, and not distended with positive bowel sounds.  He evaluated Resident 2’s abdomen as negative.  Dr. Lewis noted that Resident 2 was incontinent of bowel and bladder.  He assessed Resident 2 as stable and at his baseline and directed staff to continue with Resident 2’s care plan and monitoring.  P. Ex. 10 at 2; CMS Ex. 13 at 63.  Resident 2 was assessed by nurses on January 13 and February 14, 2017, who both noted he had trouble with constipation (there was no indication they found him constipated at the time of the assessments but also no indication they did not), he was always incontinent of bowel and bladder, but no other abnormal findings were noted.  CMS Ex. 13 at 95-98; P. Ex. 4 at 3-4. 

The evidence includes ADL Flow Records for January and February 2017.  The ADL Flow Records have spaces for staff on each shift to record whether or not Resident 2 was continent or incontinent and the total number of voids each shift – night, day, and evening.  P. Ex. 2 at 10, 14; CMS Ex. 13 at 13, 15.7  The ADL Flow Records do not have spaces to specifically record amount and consistency of a bowel movement, a requirement of Resident 2’s care plan (CMS Ex. 13 at 67; P. Ex. 1 at 2).  The ADL Flow Records do have a space for certified nursing assistant (CNA) notes, but no notes are entered in February 2017.  P. Ex. 2 at 12, 16.  The ADL Flow Records indicate that Resident 2 was sent to the hospital on February 24, 2017.  P. Ex. 2 at 14; CMS Ex. 13 at 13.  During the period of February 1 through 23, 2017, staff documented Resident 2’s bowel functions for only 34 of the 69 shifts.  From February 1 through 15, 2017, staff recorded that Resident 2 had one or more bowel movements on February 1, 2, 4, 5, 7, and 11, 2017.  P. Ex. 2 at 10.  Between February 16 and 23, 2017, staff recorded Resident 2’s bowel functions for only 9 out of 24 shifts, noting for each shift that was documented that the resident had no episodes of bowel function.  P. Ex. 2 at 10, 14.  I infer that for those shifts when the resident’s bowel status was not documented, staff either failed to make an observation or failed to record the observation.  In either case, Resident 2’s last recorded bowel movements in February 2017, occurred on February 11, 2017.  Resident 2’s care plan required that when Resident 2 had no bowel movement in three days, (that would have been February 12, 13, and 14, 2017), the resident should have been assessed for constipation, a bowel assessment should have been done, and his physician notified.  P. Ex. 1 at 2; CMS Ex. 13 at 67.  The evidence does not show that:  Resident 2 was assessed for constipation, a bowel assessment was done, or the physician was notified as required by the care plan.  Petitioner presented the unsworn statements of several staff

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members who cared for Resident 2, but they do not state that they knew Resident 2 had a bowel movement during the period of February 12 through 24, 2017.  Some of the staff members’ statements indicate that they did not hear Resident 2 complain of constipation or symptoms of bowel obstruction.  P. Ex. 9.  However, that is not evidence that the resident had a bowel movement and the absence of a bowel movement for three days is what triggered the requirements of the care plan, not resident complaints. 

Petitioner’s Administrator, Marie Lawson, testified that Resident 2 and his family never complained about the care he received or about his bowel status.  Tr. 523-24, 537.  Ms. Lawson testified that Resident 2 was not always able to tell if he needed to defecate due to his condition.  Tr. 548.  She did not explain how, if Resident 2 did not always know if he needed to defecate, he could know that he was constipated and could not defecate.  Ms. Lawson testified that three different CNAs attend to a resident during a 24-hour period.  Tr. 554.  Ms. Lawson testified that Resident 2’s diaper was to be checked every two hours and she thought his diaper was probably changed a couple times each shift.  Tr. 549.  Ms. Lawson confirmed that the CNAs were responsible for documenting a resident’s bowel and bladder status, including when a resident had a bowel movement.  Tr. 552.  Ms. Lawson conceded that Resident 2’s bowel movements were not always documented by the CNAs on the ADL Flow Records.  Tr. 552-55, 558-59.  Ms. Lawson testified that during weekly weight meetings and other staff meetings resident bowel and bladder issues were discussed and no problems related to Resident 2’s bowel status came up.  Tr. 533-36.  Nevertheless, she claimed that, based on her interviews with the nurses and CNAs, Resident 2 was having bowel movements up until the time he was transferred to the hospital and had no problems with his bowel status.  Tr. 558-60.  However, the statements of staff placed in evidence by Petitioner do not support Ms. Lawson’s belief because staff do not state that Resident 2 had bowel movements after February 11, 2017.  Ms. Lawson conceded that if no bowel movement was documented by staff, it would not be possible to know whether a resident had a bowel movement, unless a nurse followed up with the CNA assigned to that particular shift or spoke to the resident directly.  Tr. 553-55.  There is no documentation showing that follow-up, as described by Ms. Lawson, occurred after February 11, 2017.  Therefore, Ms. Lawson’s testimony that Resident 2 continued to have bowel movements is unsupported by any evidence other than her own recollection and she did not testify that she either delivered direct care to Resident 2 or was otherwise aware of Resident 2 defecating after February 11, 2017.  Even if her recollection is correct, the fact that Resident 2 may have had one or more bowel movements after February 11 and before February 24, 2017, does not excuse the fact that bowel movements were not recorded or that the absence of recorded bowel movements were not reported to the resident’s physician or physician’s assistant (PA) for follow-up.  Furthermore, Resident 2’s care plan (CMS Ex. 13 at 67) required that the amount and consistency of his bowel movements be monitored and there is no evidence that monitoring actually occurred.

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On February 22, 2017, PA Josie Juleau was contacted about Resident 2’s 19-pound weight loss.8  P. Ex. 4 at 2; CMS Ex. 13 at 88.  The evidence does not show that PA Juleau was advised that Petitioner’s ADL Flow Record recorded no bowel movement for Resident 2 since February 11, 2017.  PA Juleau ordered laboratory testing, a dietary consultation, and a hospice consultation.  On February 23, 2017, Resident 2’s family was advised of developments.  On February 23, 2017, PA Juleau ordered a portable chest x‑ray and a urinalysis test for Resident 2.  Later that day, PA Juleau went to the facility and examined Resident 2 due his reported refusal to eat, a 27-pound weight loss in three months, and a 19-pound weight loss over a month. P. Ex. 4 at 2; P. Ex. 10 at 1; CMS Ex. 13 at 62, 88.  As part of her assessment, PA Juleau examined Resident 2’s abdomen and documented that it was soft, not tender, not distended, with bowel sounds and she concluded that the abdominal assessment was negative.  PA Juleau noted that Resident 2 only took soda and snacks and that he was refusing meals and supplements.  PA Juleau added anorexia as a diagnosis.  P. Ex. 10 at 1; CMS Ex. 13 at 62.  There is no evidence that PA Juleau or Dr. Lewis were informed that Resident 2’s last recorded bowel movement was on February 11, 2017.

On February 24, 2017, Petitioner’s staff noticed blood in Resident 2’s urine.  After being notified by staff, Resident 2’s physician ordered that Resident 2 be sent to the ER for evaluation.  P. Ex. 3 at 1, 14; P. Ex. 4 at 2; CMS Ex. 13 at 88.  The facility’s Resident Transfer Form, dated February 24, 2017, reported that Resident 2 was alert and that he was being transferred for the following reasons:  blood had been noted in his urine specimen that was obtained by catheterization; and he had poor oral intake, resulting in a 19-pound weight loss in a month.  P. Ex. 3 at 2-3; CMS Ex. 14 at 1-2.  Staff also noted the following:  Resident 2 refused meals 90 percent of the time; he ate junk food and only drank sodas; his white blood cell count was elevated; he had a history of urinary tract infections and pneumonia; lung sounds with rhonchi; and he was dependent on staff for all ADLs.  P. Ex. 3 at 3; CMS Ex. 14 at 1.

Resident 2 was admitted to the hospital on February 24, 2017.  The hospital’s history and physical report for Resident 2, dated February 24, 2017, states, among other things, that Resident 2 had decreased his intake over the last six weeks.  The report states that

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Resident 2 had not had a bowel movement in an unknown amount of time and he complained of constipation, abdominal pain, night sweats, and fatigue.  CMS Ex. 15 at 1, 4.  Resident 2 was given magnesium citrate (a laxative) and a mineral oil enema at about 3:15 p.m. on February 24, 2017.  CMS Ex. 15 at 3.  His general appearance was described as “cachectic/emaciated,” “chronically ill appearing,” and “underweight.”  CMS Ex. 15 at 5.  The physician documented that Resident 2’s abdomen was soft, active bowel sounds were heard, and the resident had mild tenderness to palpation mostly in the left upper quadrant.  CMS Ex. 15 at 5. 

At the hospital, Resident 2 underwent a CT scan of his abdomen and pelvis on February 24, 2017.  The scan was reviewed by a doctor who reported that:  Resident 2 had “[a] severe amount of stool” within his rectum, right colon, and transverse colon; the amount of stool within the rectum raised the concern of fecal impaction; and “there is associated mild small bowel dilation with air, which could be related to ileus.”  CMS Ex. 15 at 21.  Disimpaction was ordered to help with Resident 2’s constipation and to possibly resolve the ileus when the stool was cleared.  CMS Ex. 15 at 22-23.  The fact disimpaction was ordered is good evidence Resident 2 was not only suffering from constipation but was impacted at the time of examination.

According to a hospital report dated February 25, 2017, a physician examined Resident 2 and found his abdomen distended, tender to palpation, and with minimal bowel sounds.  P. Ex. 7 at 9; CMS Ex. 15 at 9.  The report states that, “despite exhaustive efforts at free water enema and fecal disimpaction, minimal stool [was] expelled,” and disimpaction was unsuccessful.  CMS Ex. 15 at 8, 13; P. Ex. 7 at 6.  The findings were discussed with Resident 2’s family.  The family concurred with the physician’s concern that Resident 2 was “too malnourished and frail for more invasive procedures for fecal disimpaction.”  The family understood that Resident 2 could develop further complications such as toxic megacolon and/or bowel perforation.  They requested a hospice consultation.  CMS Ex. 15 at 8, 13, 15; P. Ex. 7 at 6.

A hospice representative evaluated Resident 2 on February 25, 2017.  The representative found that Resident 2 was appropriate for hospice due to the fact he had a bowel obstruction and was not a candidate for surgery.  CMS Ex. 15 at 33.  On February 26, 2017, Resident 2 was discharged from the hospital to hospice care.  P. Ex. 7 at 1, 6-7.  Examination on February 26, 2017, showed that Resident 2’s abdomen was distended, tender to palpation, with bowel sounds present and no guarding or rebound tenderness.  P. Ex. 7 at 3.  The discharge diagnoses listed in the report were failure to thrive due to severe constipation, sepsis due to a history of aspiration pneumonia, ileus, hematuria and proteinuria, epilepsy, hypertension, GERD, and traumatic brain injury with residual left hemiplegia, which are identical to those listed at the time of Resident 2’s admission to the hospital.  P. Ex. 7 at 5-6.  On February 27, 2017, a physician evaluated Resident 2 for hospice stating that the resident had a bowel obstruction and required intensive pain

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management.  CMS Ex. 15 at 29.  Resident 2 passed away on March 6, 2017, at the hospice facility.  CMS Ex. 15 at 69; CMS Ex. 16. 

(ii)  Petitioner’s Policy Regarding Resident Neglect

Petitioner had policies and procedures concerning the prohibition and prevention of resident abuse and neglect.  P. Ex. 12; CMS Ex. 23.  Petitioner’s policy, with a copyright date of 2001, provided that Petitioner would not “condone any form of resident abuse or neglect . . . . all personnel are to report any signs and symptoms of abuse/neglect to their supervisor or to the director of nursing immediately.”  P. Ex. 12 at 2.  Petitioner’s policy defined “neglect” as the “failure to provide goods and services as necessary to avoid physical harm, mental anguish, or mental illness.”9   P. Ex. 12 at 2.  With respect to signs of physical neglect, the policy provided the following non-inclusive list:  malnutrition and dehydration (unexplained weight loss); poor hygiene; inappropriate clothing (soiled, tattered, poor fitting, lacking, inappropriate for season); decayed teeth; improper use/administration of medication; inadequate provision of care; caregiver indifference to resident’s personal care and needs; failure to provide privacy; and leaving someone unattended who needs supervision.  P. Ex. 12 at 2.  Petitioner also had an undated policy titled “Reportable and Non-Reportable Events Manual.”  P. Ex. 12 at 12-16; CMS Ex. 23.  The manual states, in relevant part, that its purpose is “to provide guidance to the facility administration regarding the action required in the event of suspected or alleged abuse, neglect, exploitation and other serious scenarios.”  P. Ex. 12 at 12; CMS Ex. 23 at 1.  The manual states that residents have the right to be free from abuse, neglect and exploitation.  The manual adopts a definition of “neglect” (citing to 40 Tex. Admin. Code § 19.101(81)) which states “[t]he failure to provide goods or services, including medical services that are necessary to avoid physical or emotional harm, pain, or mental illness.”  P. Ex. 12 at 13; CMS Ex. 23 at 2.  The manual states further, “[t]he facility must determine if an injury, harm to or death of a resident was due to a facility failure to provide services, treatment or care to a resident.”  The policy notes that, as a SNF, it is also subject to the definition of neglect in 42 CFR § 488.301, and the prohibition of neglect under 42 C.F.R. § 483.13(c)10 (F224).  P. Ex. 12 at 13; CMS Ex. 23 at 2.  A

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resident’s care plan specifies the care that the resident’s IDT determines is necessary for the resident.  Therefore, failure to deliver care as directed by the care plan meets the definition of neglect and is an example of an inadequate provision of care, an example listed in Petitioner’s policy as evidence of neglect. 

(iii)  Petitioner’s Experts

Petitioner called Robert W. Parker, MD, to testify as an expert in geriatric medicine.  Tr. 428-32; P. Ex. 25.  Dr. Parker testified that during his career he has treated patients with bowel obstructions, fecal impactions, and constipation.  Tr. 435, 447.  Dr. Parker testified that fecal impaction and constipation are very common conditions in nursing home residents, and those who are bedfast or immobile are more likely to be constipated.  Tr. 447, 449-50.  Dr. Parker testified that Resident 2 was on a drug that dries the mouth and bowels, causing constipation.  Tr. 450, 486-87.  He noted that Resident 2 may also have had decreased sympathetic nerve function that affected his bowels.  Tr. 451.  Dr. Parker agreed on cross-examination that loss of appetite could be a symptom of fecal impaction.  Tr. 489.  Dr. Parker confirmed on cross-examination that the document at CMS Ex. 13 at 67 was Resident 2’s care plan for constipation.  Tr. 489.  He agreed that if Petitioner’s staff had identified Resident 2 as at risk for constipation, then he was also at risk for fecal impaction and bowel obstruction.  Tr. 490.  Dr. Parker testified that it is important to monitor bowel movements and it is not uncommon for a person to go a week without a bowel movement.  Tr. 492.  Dr. Parker testified that a three-day period without a bowel movement is not a concern, but seven days without a bowel movement is a concern.  Tr. 499-500.  Dr. Parker did not testify that the goal of Resident 2’s care plan that he have a bowel movement no less often than every three days was in error.  He testified that if he had a patient who had not had a bowel movement in 10 days, he would wish to know that information, particularly if the resident was incontinent.  Tr. 493, 499.  Dr. Parker testified that caring for a resident and documentation of care are both important.  Documentation is necessary to help the healthcare team understand what is going on with a resident so that they can care for the resident.  Tr. 437-38.  He testified that the ADL Flow Records were not completely filled out for Resident 2, but stated it was typical of what occurs in many nursing homes.  He testified that staff gets busy and they do not have time to complete all documentation.  He opined that it is not possible to document everything staff does with a resident.  Tr. 436-37.  Dr. Parker did not testify it was acceptable not to document care when that care is required by a care plan.  Dr. Parker noted that issues that affect care are frequently discussed at staff meetings and quality assurance committee meetings.  Tr. 439-40, 494.  Dr. Parker did not testify that he saw evidence that Resident 2’s bowel activity was discussed at any meeting and he was

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not present at any meetings at Petitioner.11  Tr. 494-95, 509-10.  On cross-examination, Dr. Parker agreed that documentation done by the CNAs would assist the licensed nurses in understanding a resident’s condition.  Tr. 493-94.  He also agreed that if something is not documented in the records, he personally would have no knowledge as to whether the information was communicated.  Tr. 495.

Dr. Parker testified that Resident 2 had been a resident of Petitioner for five years and he only had problems with bowel function near the end, and his chronic constipation was being treated with MiraLax® and Colace®.  Tr. 452.  Dr. Parker testified that he did not see any complaints by Resident 2 consistent with a bowel obstruction such as abdominal pain, bloating, or vomiting during the last two weeks of Resident 2’s stay at Petitioner’s facility.  Tr. 456-57.  He pointed out that when PA Juleau examined Resident 2 on February 23, 2017, there was no evidence of abdominal tenderness or pain, and bowel sounds were normal, with no abdominal distention.  Tr. 458.  According to Dr. Parker, Resident 2 did not express any concerns to the PA about not being able to have a bowel movement, and, based on the normal abdominal findings, the PA would not have had a reason to order a rectal examination, which would have been necessary to diagnose a fecal impaction.  Tr. 453-54, 487-88, 500.  Dr. Parker did not speculate that PA Juleau may have ordered or conducted a rectal examination had she known that the records showed the resident last had a bowel movement more than ten days prior to her visit.  Dr. Parker explained that a fecal impaction does not always cause a bowel obstruction and that its symptoms include pain, straining or inability to have a bowel movement, bleeding, and diarrhea.  Tr. 454, 457-58, 488-89.  Dr. Parker testified that he found no evidence that a rectal examination was performed on Resident 2, either at Petitioner’s facility or at the hospital.  Tr. 453, 475, 487.  Dr. Parker testified that Resident 2 was sent to the hospital because blood was detected in his urine sample.  Tr. 465-66.  In response to my questioning, Dr. Parker testified that he saw nothing related to Resident 2’s bowel condition that would have required hospitalization on February 24, 2017.  Tr. 480-81.  According to Dr. Parker, had Resident 2 not had blood in his urine or exhibited a significant weight loss, there would have been no reason to send him to the hospital.  Tr. 484.  Dr. Parker testified that Resident 2’s hospital admission diagnoses did not make any reference to constipation, impaction, or obstruction; however, his testimony is inaccurate, for the admission diagnoses included “failure to thrive due to severe constipation.”  Tr. 464-65; P. Ex. 7 at 5.  Dr. Parker testified that the emergency room assessment revealed no significant abdominal findings and Resident 2 still had positive bowel sounds.  However, over the next two days, Resident 2 developed bloating, some abdominal tenderness, and diminished bowel sounds.  Tr. 461.  Dr. Parker opined that

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Resident 2 did not have a bowel obstruction when he arrived at the hospital, rather, he was very constipated.  Tr. 456, 459, 475.  Dr. Parker pointed out that nothing in the hospital records contained any evidence that Resident 2 had been diagnosed with a bowel obstruction or that he suffered a bowel obstruction during his hospital stay.  Tr. 454, 457, 463.  Had Resident 2 had a bowel obstruction, Dr. Parker testified that he would have expected the hospital to have placed a nasogastric tube but that was not done.  Tr. 457, 464.  In response to my questioning, Dr. Parker stressed that the radiologist did not report a diagnosis of fecal impaction or bowel obstruction.  Tr. 482.  He did not deny however, that the radiologist identified a “severe amount of stool . . . within the rectum, right colon, and transverse colon” or that the radiologist expressed concern about fecal impaction and a possible ileus.12   CMS Ex. 15 at 21.  In response to my questioning, Dr. Parker testified that the hospital did not use aggressive measures to attempt to clear Resident 2’s bowel but admitted that may have been due to family request as there was an ongoing discussion about admitting the resident to hospice.  Tr. 475-80.  Dr. Parker opined that there was no action or inaction on the part of Petitioner’s staff that caused Resident 2 to have a severe amount of stool in his colon.  Tr. 468.  However, he also testified that if Resident 2 was not having a bowel movement, the resident’s physician should have been notified and an examination should have been done.  Tr. 460. 

Dr. Parker opined that Petitioner did not neglect Resident 2, did not deprive him of any services he needed to increase his quality of life, and did not put him at risk of imminent harm.  Tr. 466, 469-71.  Dr. Parker expressed these opinions ignoring the fact that:  staff had not recorded that Resident 2 had a bowel movement after February 11, 2017; there is no evidence of compliance with Resident 2’s care plan requirement that amount and consistency of his bowel movements be monitored; a CT confirmed that Resident 2 arrived at the hospital with a severe amount of stool in his colon; the CT was then interpreted by a radiologist as concerning for impaction and ileus; and unsuccessful efforts were made at the hospital on February 24 and 25, 2017 to clear the stool.  Considering Petitioner’s failures, I conclude that Dr. Parker failed to consider all the facts when developing his opinions and his opinions of no neglect and no harm are simply not credible and weighty.

Petitioner also called as an expert witness, Pearl Merritt, RN, MSN, Ed.D.  Based on her qualifications, I accepted Dr. Merritt as an expert in the areas of nursing home administration and geriatric health care, and qualified to testify about the nursing standard of care in long-term care facilities.  Tr. 596, 610, 613-14.

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Dr. Merritt testified that it is not possible for staff to document everything done for a resident.  She testified that, in addition to the written documentation in a resident’s chart, nursing home staff communicate about a resident at shift changes, through 24-hour logs (which are not documented in a resident’s chart); and through meetings, such as quality assurance and weekly staff meetings.13   Tr. 598-99, 601-03.  I note that Dr. Merritt did not testify to having witnessed any meeting at which Resident 2’s bowel status was discussed.  When asked generally about ADL Flow Records, Dr. Merritt testified that “they should be documented.”  Tr. 604-05. 

Dr. Merritt testified that she reviewed the documents pertaining to Resident 2 which were contained in Petitioner’s exhibits.  Tr. 608-09, 612-13.  Based on her review, Dr. Merritt noted that Resident 2 had experienced weight loss, did not have a well-balanced diet, would refuse to eat, had swallowing difficulties, and had a history of aspiration pneumonia.  Tr. 616, 619, 626-28, 635-36.  Dr. Merritt testified that, although the nurse aide sheets (I infer the reference is to the ADL Flow Records, P. Ex. 2) were not completely filled out, she believed, based on her training and experience, that Resident 2’s bowel status was monitored during the month of February 2017.  Tr. 637.  Dr. Merritt’s opinion that monitoring of Resident 2’s bowel status occurred on those shifts and dates when no recording was made on the ADL Flow Records (P. Ex. 2), is speculation.  Dr. Merritt’s opinion is not acceptable as her training and experience are not a sufficient basis for the opinion she expressed, particularly as it is not based on facts reflected in the evidence she considered.  Dr. Merritt described the PA’s February 23, 2017 report as “excellent,” and noted on cross-examination that the PA thoroughly examined Resident 2’s abdomen and found it was soft, which indicated that the PA had checked his bowels.  Tr. 638, 657, 704.  In response to my questioning, Dr. Merritt testified that the PA found nothing consistent with a bowel obstruction.  Tr. 705.  Dr. Merritt did not speculate that the PA may have conducted a rectal examination if she had known that Petitioner’s records showed that Resident 2 had not had a bowel movement in more than ten days. 

Dr. Merritt opined that the nursing care provided to Resident 2 met the applicable standard of care or standard of practice.  Tr. 638-39.  Dr. Merritt expressed this opinion ignoring that:  staff had not recorded that Resident 2 had a bowel movement after February 11, 2017; there is no evidence staff monitored the amount and consistency of Resident 2’s bowel movements though that was required by his care plan; Resident 2 arrived at the hospital with a severe amount of stool in his colon that was confirmed by

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CT and interpreted by a radiologist as concerning for impaction and ileus; and unsuccessful efforts were made at the hospital on February 24 and 25, 2017 to clear the stool.  Considering Petitioner’s failures, I conclude that Dr. Merritt failed to consider all the facts when developing her opinions and her opinion that applicable standards of care or practice were met are simply not credible and weighty.

On cross-examination, Dr. Merritt agreed that Resident 2’s care plan (CMS Ex. 13 at 67) required that his bowel movements be monitored for amount and consistency.  She testified that Petitioner’s nurse aides would have been responsible for monitoring Resident 2’s bowel movements.  Dr. Merritt admitted that she recalled no documentation in Resident 2’s records, including the nursing notes (P. Ex. 4) and weight meeting minutes, regarding the amount and consistency of his bowel movements.  She agreed she did not witness any meetings or discussions among staff regarding Resident 2’s bowel status.  Tr. 653-58, 694-95.  On redirect examination, Dr. Merritt testified that staff can monitor a resident through observing, and that if there were no problems with Resident 2’s bowel movements, she would not expect to see that recorded.  Tr. 685-86.  However, in response to my questioning, she conceded that if there is no documentation, one cannot prove that monitoring actually occurred or that one knew what a resident’s status was.  Tr. 699-700.  Dr. Merritt also did not opine as to whether the fact Petitioner’s records showed Resident 2 last had a bowel movement on February 11, 2017, should have clearly alerted staff to the possible constipation of Resident 2.  It is noteworthy that Petitioner offered no testimony that the ADL Flow Records for Resident 2 (P. Ex. 2) were actually reviewed by anyone on staff.  Had the ADL Flow Records been reviewed, either the failure of staff to document or the possible constipation of Resident 2 might have been identified.  

While Dr. Merritt has sufficient experience and credentials to evaluate the care received by Resident 2, I do not find credible or weighty her opinion that Petitioner’s staff monitored Resident 2’s bowel status during the period February 12 through 24, 2017, absent some evidence on which she bases that opinion.  In fact, her opinion is undermined by her own admissions that there was no documentation in Resident 2’s record regarding his bowel movements (I consider the pertinent period to be after February 11, 2017 through the resident’s hospitalization on February 24, 2017) and that, without documentation, there is no proof that monitoring occurred.

Dr. Merritt testified that, based on her review, Petitioner had implemented its abuse and neglect policies, citing the in-service training provided to its staff.  Tr. 640-41.  Dr. Merritt addressed whether Petitioner’s staff were trained on facility policies addressing resident neglect.  Dr. Merritt did not address Petitioner’s failure to deliver necessary care and services to Resident 2, specifically monitoring that he had bowel movements, including consistency and amount to determine whether he was constipated and needed further examination and treatment as ordered by his care plan.  Therefore, Dr. Merritt did not opine that the failure to deliver necessary care and service to Resident

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2 did not amount to neglect.  She also did not opine that the evidence that Resident 2 was neglected was not evidence that Petitioner’s policy prohibiting neglect was not implemented, at least in the case of Resident 2. 

Dr. Merritt testified that, based on her review of the records related to Resident 2, that there was no immediate jeopardy.  Tr. 647-48.  No foundation was established for this opinion, i.e., that Dr. Merritt knew the definition of immediate jeopardy or how it is determined.  Absent a foundation establishing a basis for Dr. Merritt’s opinion, I find the opinion neither credible nor weighty. 

b.  Analysis

I conclude based on my findings of fact that Petitioner:

Violated 42 C.F.R. § 483.12 as alleged in the SOD under Tag F223;

Violated 42 C.F.R. § 483.12(b) as alleged in the SOD under Tag F226;

Violated 42 C.F.R. § 483.25 as alleged in the SOD under Tag F309; and

Each regulatory violation posed a risk for more than minimal harm for Resident 2.

Petitioner violated 42 C.F.R. § 483.12 because Petitioner failed to ensure that Resident 2’s care plan for constipation was followed.  The resident’s IDT determined he had a history of constipation and was at risk for impaction and bowel obstruction and created a comprehensive care plan to address the history and risk.  The IDT set a goal for Resident 2 to have a bowel movement no less often than every three days with no resulting impaction or bowel obstruction.  To meet its goal, the IDT required monitoring of the resident’s bowel movements, including frequency, consistency, and amount.  There is no evidence that Resident 2 had a bowel movement between February 12 and 24, 2017, a period of more than three days.  There is no evidence that Petitioner’s staff took actions required by Resident 2’s care plan when Resident 2 did not have a bowel movement recorded in more than three days.  There is also no evidence that Petitioner’s staff actually monitored the amount and consistency of Resident 2’s bowel movements as required by his care plan. 

Resident 2’s care plan reflects the care and services that Resident 2’s IDT determined were necessary for the resident.  The regulatory definition of neglect applicable to SNFs is found in 42 C.F.R. § 488.301, which defines neglect as:  “the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.”  The Board has accepted that a facility’s failure to provide a resident with the care required by his care plan supports a conclusion that the resident was neglected.  The Cottage

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Extended Care Ctr., DAB No. 2145 at 4-5 (2008).  Therefore, I conclude that Petitioner’s failure to ensure that Resident 2’s care plan was followed amounts to neglect under the regulatory definition.  There is no dispute that fecal impaction or bowel obstruction are more than minimal harm or that constipation may cause discomfort. 

Having concluded that Resident 2 was neglected, it follows that Petitioner failed to ensure staff followed, i.e., implemented, Petitioner’s policy prohibiting neglect of residents.  The regulation requires: 

(b) The facility must develop and implement written policies and procedures that:

(1) Prohibit and prevent abuse, neglect, and exploitation of residents and misappropriation of resident property,

(2) Establish policies and procedures to investigate any such allegations, and

(3) Include training as required at paragraph § 483.95.

42 C.F.R. § 483.12(b)(1)-(3).  Violation of these regulatory requirements may be established if a SNF either fails to develop policies or procedures adequate to prevent neglect or fails to implement such policies.  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703 at 6 (2016).  The Board has explained that, in examining whether a facility has implemented policies and procedures to prohibit neglect, the issue is “whether the circumstances presented, viewed as a whole, demonstrate a systemic problem in implementing policies and procedures.”  Columbus Nursing & Rehab. Ctr., DAB No. 2247 at 27 (2009); Liberty Commons Nursing & Rehab Ctr.–Johnston, DAB No. 2031 at 14 (2006), aff’d, Liberty Commons Nursing & Rehab Ctr.–Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007).  Further, the fact only one resident was cited as an example under Tag F226 does not lead to the conclusion that there was no “systemic” failure in the implementation of Petitioner’s neglect policy.  The Board has stated that the question of whether there is a systemic failure is not determined based simply on the number or nature of the instances of neglect.  Determination of whether there is a systemic failure also requires consideration of the surrounding circumstances and whether they reflect a breakdown in the implementation of the facility policy prohibiting neglect.  Southpark Meadows, DAB No. 2703 at 6; Oceanside Nursing & Rehab. Ctr., DAB No. 2382 at 11 (2011); Columbus Nursing & Rehab. Ctr., DAB No. 2247 at 27.  Relevant factors to consider include number of staff involved and whether their actions were contrary to facility policy.  Southpark Meadows, DAB No. 2703 at 6; Hanover Hill Health Care Ctr., DAB No. 2507 at 9-10 (2013).  

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There is no question that Petitioner had the required policy that prohibited neglect of residents, among other things.  P. Ex. 12 at 2-3, 13; CMS Ex. 23; P. Br. at 20; CMS Br. at 12.  However, Petitioner’s staff neglected Resident 2.  The evidence shows the neglect of Resident 2 was a systemic failure in implementation of Petitioner’s neglect prevention policy.  During the period February 1 through 23, 2017, multiple CNAs, on multiple shifts, failed to document that they had monitored Resident 2’s bowel movements as required by his care plan.  Resident 2’s care plan also required that if he did not have a bowel movement for three days, a bowel assessment was to be performed and his physician notified.  After February 11, 2017, no bowel movement by Resident 2 was recorded in the ADL Flow Records for more than three days.  However, Petitioner’s staff failed to recognize that there was no evidence that Resident 2 was having bowel movements and that further action was required to either follow Resident 2’s care plan or correct the record based on credible observations of Resident 2 by staff.  There is no evidence that after three days, Resident 2 received a bowel assessment or that his physician was notified as required by his care plan.  There is no evidence that the consistency and amount of Resident 2’s bowel movements were ever monitored by staff even though such monitoring was required by Resident 2’s care plan.  The evidence shows a systemic failure to ensure that Resident 2 was not neglected.  Accordingly, there is a prima facie showing that Petitioner violated 42 C.F.R. § 483.12(b).  Petitioner has failed to meet its burden to show by a preponderance of the evidence that it was in substantial compliance with the requirement of 42 C.F.R. § 483.12(b). 

I also conclude that Petitioner violated 42 C.F.R. § 483.25, based on the same analysis as the violation of 42 C.F.R. § 483.12 (as alleged under Tag F323). The regulation at 42 C.F.R. § 483.25 requires a SNF to provide each of its residents, based on the resident’s comprehensive assessment, with treatment and care in accordance with professional standards of practice, the resident’s comprehensive care plan, and the resident’s choices.  Monitoring Resident 2’s bowel status, including frequency, amount, and consistency, was determined to be a necessary care and service by Resident 2’s IDT to avoid harm due to impaction or bowel obstruction.  No monitoring of consistency or amount is shown by the evidence, and, between February 12 and 24, 2017, interventions required by the care plan were not implemented when staff recorded no bowel movement for more than three days.  As a result, Resident 2 was constipated on arrival at the hospital on February 24, 2017.  There is no question that constipation may lead to more severe conditions of impaction and bowel obstruction and poses a risk for more than minimal harm.  Resident 2’s care plan was not followed which is a violation of 42 C.F.R. § 483.25 and that violation posed a risk for more than minimal harm to Resident 2.

Petitioner attacked the qualifications and credibility of Surveyor/Investigator Candace Amanchuku; her findings and allegations in the SOD; her testimony; and the manner in which she conducted the survey.  P. Br. at 1-2; P. Reply at 5-7, 20.  Petitioner argued that Surveyor Amanchuku lacked the qualifications and the requisite knowledge to understand the medical issues and documentation in this case.  P. Br. at 1-2; P. Reply at 5, 20.  It is

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true that Surveyor Amanchuku does not have a nursing or medical background.  However, she is a trained surveyor with survey experience.  A surveyor is not expected to make a diagnosis.  Rather, a surveyor is required to make findings and conclusions as to whether a provider is in substantial compliance with program participation requirements, which requires her to conclude whether or not there is a potential for more than minimal harm. 42 C.F.R. § 488.10(a)(1).  More importantly, however, it is not necessary for me to rely upon the surveyor’s findings or conclusions in conducting in my de novo review.  Rather, I conduct a de novo review of all the evidence to determine whether Petitioner violated a regulatory or statutory participation requirement and whether the violation posed a risk for more than minimal harm.  Therefore, Surveyor Amanchuku’s qualifications and survey performance have no real impact on the outcome in this case.  The regulations are clear that any inadequacies in survey performance do not relieve a facility from meeting all the requirements of program participation or invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b).  The Board made clear in Avon Nursing Home, DAB No. 2830 (2017), that the surveyor’s and CMS’s view of the evidence are irrelevant to an ALJ’s de novo review, except to the extent CMS relies upon unreliable evidence as supporting its findings and conclusions of noncompliance.  The Board explained:  

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

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

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Petitioner argues that there was no noncompliance as alleged in the SOD under Tag F223.  Petitioner takes issue with the fact that the surveyor and CMS erroneously claim that Resident 2 was suffering from a bowel obstruction and the surveyors claim that bowel obstruction led to Resident 2’s death.  P. Br. at 2.  Whether Resident 2 actually had a bowel obstruction when he was transferred to the hospital on February 24, 2017, and whether a bowel obstruction was the actual cause of his death are not facts that have any real bearing on the outcome in this case.  Petitioner failed to ensure that Resident 2’s care plan for constipation was followed as directed by the resident’s IDT.  Petitioner’s failure to ensure Resident 2’s care plan was followed is the factual basis for concluding that Petitioner violated 42 C.F.R. §§ 483.12, 483.12(b), and 483.25.  The care plan provides evidence that the IDT determined that untreated and unresolved constipation may lead to impaction and bowel obstruction and poses the risk for more than minimal harm. 

Petitioner asserts that Resident 2’s weight loss (which is not alleged as the basis for noncompliance in the SOD) and “bowel related issues were clinically unavoidable” based on his personal choices.  P. Br. at 3-4.  Petitioner’s assertion that Resident 2’s constipation was clinically unavoidable is not supported by any expert medical or other opinion in evidence.  However, even if the resident’s bowel habits may have been impacted by his poor choice of diet, that fact did not prevent staff from monitoring whether Resident 2 was having bowel movements, their amount, and their consistency as required by his care plan.  Petitioner asserts that the surveyors’ “primary criticism . . . is that the nursing home staff did not recognize signs and symptoms of bowel obstruction.”  P. Br. at 5.  However, that is not true.  The surveyors clearly alleged that Petitioner “failed to consistently monitor Resident #2’s bowel function in February 2017.”  CMS Ex. 3 at 2, 20, 38.  The surveyors note that the resident was transferred to the hospital on February 24, 2017, and he subsequently died from sepsis due to a bowel obstruction.  However, the surveyors did not allege that either the transfer to the hospital or the bowel obstruction were the basis for the citation of noncompliance.  CMS Ex. 3 at 2-55. 

Petitioner admits in a footnote that documentation of monitoring of Resident 2’s bowel function could have been much better.  Petitioner argues, however, that staff statements show that Resident 2 was “having bowel movements every few days up through the time of his discharge” citing P. Exs. 4, 9, and 10.  P. Br. at 5-6.  P. Ex. 4 includes nurse notes for the period February 3 through 24, 2017, which do not document that Resident 2 had a bowel movement during that period.  P. Ex. 4 at 1-4.  P. Ex. 9 includes unsworn statements of staff members, none of whom state that Resident 2 had a bowel movement between February 12 and 24, 2017.  P. Ex. 10, page 1 is the February 23, 2017 progress note of PA Juleau, which also does not state that Resident 2 had a bowel movement between February 12 and 24, 2017, through she did report negative findings related to the resident’s bowel, except that he was incontinent.  Petitioner also cited to testimony by Dr. Parker (Tr. 454) but Dr. Parker made no first-hand observations of Resident 2 or his bowel movements.  In fact, Dr. Parker opined that, though Resident 2 did not have a bowel obstruction, he was very constipated.  Tr. 456, 459, 475.  Dr. Parker’s opinion that

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Resident 2 was very constipated is consistent with findings that Resident 2 had not had a bowel movement for some time.

Petitioner does not deny that on February 24, 2017, shortly after Resident 2 was admitted to the hospital, a CT scan was conducted.  The report of the scan showed a “severe amount of stool” in the rectum, right colon, and transverse colon.  CMS Ex. 15 at 20-21; P. Br. at 15.  The presence of the amount of stool identified by CT shortly after the resident’s hospital admission is consistent with the resident not having a bowel movement for some time prior to his transfer from Petitioner.  Petitioner recognized that the risks for leaving the stool included toxic megacolon, bowel perforation, and possible sepsis.  P. Br. at 15.  Efforts to free the stool were ineffective and rather than more aggressive action, the family elected to place Resident 2 in hospice where he subsequently died.  P. Br. at 15.  Petitioner argues that Resident 2’s condition was not critical when he was admitted to the hospital and his condition worsened while he was in the hospital.  Although the evidence shows that Resident 2’s condition worsened after his transfer from Petitioner, that does not rebut the fact that Petitioner failed to present evidence that Resident 2 actually had a bowel movement from February 12 through 24, 2017, because Petitioner’s staff failed to record any bowel movements and there is no record of consistency or amount, and staff failed to follow the resident’s care plan.  Unsworn statements of staff presented by Petitioner indicate that Resident 2 did have bowel movements, but do not state specifically when.  P. Ex. 9 at 1, 6, 7.  Staff statements indicate that Resident 2 did not complain of abdominal discomfort or that he could not defecate.  However, Administrator Lawson explained that Resident 2 was not always able to tell if he needed to defecate due to his condition.  Tr. 548.  Petitioner’s arguments are not persuasive.

Petitioner argues regarding the noncompliance cited under Tag F226, that Petitioner had the required policy and that it implemented the policy by training its staff.  P. Br. at 20.  Petitioner denies that there was any neglect of Resident 2 by Petitioner’s staff.  However, I have concluded that multiple members of Petitioner’s staff failed to follow Resident 2’s care plan – a systemic failure to implement Petitioner’s policy prohibiting resident neglect.  Petitioner’s argument is not persuasive. 

Regarding the noncompliance cited under Tag F309, Petitioner argues that Resident 2 was not denied the care and services necessary for him to achieve his highest practicable state within the meaning of the regulation.  P. Br. at 21.  However, Resident 2’s IDT determined the care and services he needed to address his problem with constipation and possible impaction and bowel obstruction, and established interventions in his care plan that were to be followed.  Interventions listed required that staff:  monitor Resident 2 for possible causes of constipation and report to the resident’s physician; monitor his bowel movements including amount and consistency; and if he had no bowel movement for three days a bowel assessment was to be done and abnormal findings were to be reported to the resident’s physician.  P. Ex. 1 at 2; CMS Ex. 13 at 67.  Staff did not record that

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Resident 2 had a bowel movement between February 12 and 24, 2017, and the evidence does not show that that fact was reported to the resident’s physician or the PA who examined the resident.  Resident 2’s care plan was not followed, and the resident arrived at the hospital on February 24, 2017 with a severe amount of stool in his colon – he was very constipated according to Petitioner’s expert Dr. Parker.  Tr. 456, 475-76.  Therefore, Resident 2 was deprived of care and services his IDT determined were necessary for him to reach his highest practicable state given his condition.  

Petitioner also argues that Petitioner had already addressed the documentation problem before the survey and that it was a violation of 42 C.F.R. § 483.75(o)14 for Petitioner to be cited for a problem already addressed by Petitioner.  P. Br. at 22.  The regulation in effect at the time of the survey provided that “[g]ood faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions.”  42 C.F.R. § 483.75(i).  In this case, Petitioner was not cited for faulty documentation which was the problem Petitioner asserts was addressed by Petitioner prior to the survey.  P. Br. at 22.  In this case, Petitioner was cited for neglecting Resident 2, failure to implement its policy prohibiting resident neglect as evidenced by the neglect of Resident 2, and failure to provide Resident 2 with necessary care and services in accordance with his comprehensive care plan.  Petitioner does not assert and has not shown that Petitioner’s quality assurance committee addressed these quality deficiencies or even recognized them prior to the survey.  The citations of noncompliance in this case based on the example of Resident 2 are not contrary to the limitation of 42 C.F.R. § 483.75(i). 

I conclude that CMS has made a prima facie showing of noncompliance as alleged under Tags F223, F226, and F309.  Petitioner has failed to rebut the prima facie showing of noncompliance by a preponderance of the evidence.

7.  Petitioner violated 42 C.F.R. § 483.25(d)(2) as alleged under Tag 323.

8.  The violation of 42 C.F.R. § 483.25(d)(2) posed a risk for more than minimal harm.

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a.  Facts

Resident 1 was the subject of the noncompliance cited by the surveyors under Tag F323.  CMS Ex. 3 at 55-62.  The surveyors cited Petitioner for a violation of 42 C.F.R. § 483.25(d) because the resident was being transferred by a single CNA when the sling broke and the resident fell and was injured.  CMS Ex. 1 at 55.

The facts related to Resident 1’s accident are not disputed.  

According to Petitioner’s Incident/Accident Report dated March 27, 2017, around 12:50 p.m., a CNA was transferring Resident 1 from a geri chair to his bed using a Hoyer® lift.  P. Ex. 16; CMS Ex. 9.  As the CNA was transferring Resident 1, one of the straps on the sling for the Hoyer® lift broke, and Resident 1 fell out of the sling about two feet to the floor.  The report states that Resident 1’s “extra . . . movements” contributed to the accident.  Staff notified Resident 1’s physician and family around 1:40 p.m. and 1:45 p.m., respectively.  Resident 1’s right shoulder was x-rayed at 4:00 p.m. on March 27, 2017.  The x-ray showed Resident 1’s right clavicle was fractured.  P. Ex. 15 at 7; P. Ex. 22 at 1; CMS Ex. 8 at 17.  Staff notified Resident 1’s physician, who ordered his transfer to the hospital for evaluation and treatment.  Resident 1 was taken to the hospital around 6:00 p.m.  P. Ex. 16; P. Ex. 22 at 1; CMS Ex. 9.

CNA Carl Hinkle was the CNA lifting the resident when the resident fell.  CNA Hinkle’s written statement dated March 27, 2017, is consistent with Petitioner’s Incident/Accident Report.  P. Ex. 15 at 8; CMS Ex. 10.  The CNA stated that he was transferring Resident 1 using the Hoyer® lift, and the “sling snapped [and] broke;” Resident 1 fell two feet on his right shoulder; and the CNA notified the charge nurse.  CNA Hinkle and another CNA lifted Resident 1 into his bed.  Resident 1 did not complain about any pain at the time.  P. Ex. 15 at 8; CMS Ex. 10.

On March 31, 2017, Petitioner filed with the state agency a report of its investigation of Resident 1’s fall and injury.  P. Ex. 15; CMS Ex. 12.  Petitioner’s report of the incident/accident and its report of investigation are consistent. 

Petitioner’s Administrator, Marie Lawson, reported the incident to the state agency on March 28, 2017 (P. Ex. 15 at 3), and she submitted an investigation report to the state agency on March 31, 2017.  P. Ex. 15; CMS Ex. 12.  In the section describing post‑investigation actions, Administrator Lawson reported that the facility checked all slings and discarded any old or worn slings.  New slings were ordered, and staff was given in-service training on the proper use of the Hoyer® lift and gait belts.  P. Ex. 15 at 5; CMS Ex. 12 at 5.

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The issue of fact to be resolved is whether there was any requirement for Resident 1 to be transferred by Hoyer® only by two or more staff. 

Surveyor Amanchuku identified CMS Ex. 22 as a policy for the use of a mechanical or hydraulic lift that she received from someone at the facility during the survey.  Tr. 77-78.  I note that CMS Ex. 22 actually has a header-line at the top of each page (normally associated with a facsimile transmission (fax-header)) with the date April 6, 2017, 1:37 p.m., the name “Pennsylvania Rehab” a facsimile number and page numbers.  CMS Ex. 22; Tr. 224, 567-68.  I infer from the fax-header that this was a document that existed at the time of the survey and was transmitted by facsimile and came into Surveyor Amanchuku’s possession during the survey.  Whether the document was sent to the surveyors by facsimile or Surveyor Amanchuku received it from some individual at Petitioner as she testified, cannot be determined.  Tr. 78.  What can be determined is that this document was received from Petitioner.  Administrator Lawson denied during the hearing that the document admitted as CMS Ex. 22 is a policy that is used at Petitioner.  Tr. 567-68.  However, Administrator Lawson was unable to explain why the facsimile header shows the document was sent from Petitioner by facsimile or why it may have been given to Surveyor Amanchuku by some member of Petitioner’s staff.  I infer, that it is more likely than not that CMS Ex. 22 was a policy of Petitioner.  Administrator Lawson did not testify that the policy statement did not exist on March 27, 2017, the date of Resident 1’s fall from the lift.  The policy provides in the first paragraph, referring specifically to the use of a hydraulic or mechanical lift, that “[i]t requires two or three staff members to safely operate and accomplish the transfer.”  CMS Ex. 22 at 1.  In describing how to use a hydraulic or mechanical lift, the policy provides that “extra staff can be used” to guide the movement of the resident and steady the chair or bed until the resident is in proper position.  CMS Ex. 22 at 2.  The policy also provides “[w]hile the staff member is raising or lowering the lift, one staff member can guide the resident to the chair [or bed] and another can steady the chair [or bed] to receive the resident.”  CMS Ex. 22 at 2-3.  Therefore, when the policy for use of the lift is followed, it is not possible to comply with the policy without the assistance of at least two staff being present.15

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Petitioner placed in evidence records of in-service training of staff.  P. Ex. 19.  Included among the materials was an “Inservice Meeting” signature sheet dated February 2 and 3, 2016, with an attached document from the Hoyer® lift company titled “How to Use a Patient Lifter a Positioning and Transfer Guide.”  P. Ex. 19 at 25.  Petitioner also placed the guide in evidence as P. Ex. 21.  The guide illustrations show only one attendant using a lift to transfer a resident and the text strongly implies that a single attendant using a lift for a transfer is permissible.  P. Ex. 19 at 25-37.  This evidence is consistent with Administrator Lawson’s testimony that the policy admitted as CMS Ex. 22 was not a policy that is used at Petitioner.  Tr. 567-68.  However, I conclude it is insufficient to rebut the evidence that CMS Ex. 22 was provided to the surveyors as evidence of Petitioner’s policy regarding use of mechanical and hydraulic lifts.  I conclude that CMS Ex. 22 was a policy of Petitioner that required at least two staff to assist with using a mechanical or hydraulic lift such as a Hoyer® lift. 

On March 27, 2017, Resident 1 fell from a Hoyer® lift.  He was 51 years old at the time.  He was initially admitted to Petitioner on December 15, 2005.  CMS Ex. 8 at 1.  Resident 2’s diagnoses included:  anemia, unspecified psychosis, anxiety disorder, moderate intellectual disabilities, hypertension and related heart disease, dysphagia, lack of coordination, unspecified convulsions, and muscle weakness, among other things.  P. Exs. 14; 18 at 1; CMS Ex. 8 at 1.  

Resident 1’s MDS assessment dated December 9, 201616 (the last MDS in evidence dated prior to Resident 1’s fall on March 27, 2017), indicates that he was totally dependent on staff for all ADLs.  Resident 1 was assessed as requiring a one-person physical assist for bed mobility, transfers, locomotion on and off the unit, dressing, eating, toilet use, and personal hygiene.  P. Ex. 23 at 1.  The MDS does not distinguish among different types of lifts, whether mechanical, gait belts, or other technics. 

Petitioner placed in evidence an ADL care plan for Resident 1 originally dated December 30, 2015, and reviewed on March 23, 2016, June 23, 2016, September 22, 2016, and March 17, 2017.  P. Ex. 14; CMS Ex. 8 at 4.  The care plan in effect on March 27, 2017,

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the day Resident 1 fell from the lift required the use of a Hoyer® lift for all transfers.  The care plan did not at that time require at least two staff members to perform a transfer using a mechanical lift.  P. Ex. 14 at 3.  Resident 1’s fall care plan dated December 30, 2015, and unchanged by reviews on March 23, 2016, June 23, 2016, September 22, 2017, and March 17, 2017, and that was in effect when Resident 1 fell, required total assistance of staff for transfers using a gait belt or Hoyer® lift and did not specify how many staff should participate in a transfer.  P. Ex. 14 at 11.   

Dr. Parker testified that most transfers of residents in nursing homes are by one person using a Hoyer® lift.  He testified he found nothing in Resident 1’s record that required that the resident be transferred by more than one staff member.  He attributed Resident 1’s fall to failure of the lift sling and opined it was no fault of Petitioner’s staff.  Tr. 472‑74.  Dr. Parker did not address Petitioner’s policy in evidence (CMS Ex. 22) that required two or more staff to conduct transfers using a mechanical or hydraulic lift.

Dr. Merritt testified that she is familiar with and has used mechanical and hydraulic lifts like Hoyer® lifts and trained nursing home staff in the use of such lifts.  She opined that safe operation required only one person.  She also opined that it was appropriate for one staff member to transfer Resident 1 with a Hoyer® lift.  Tr. 642-46.  Dr. Merritt was not asked to consider or opine about whether Petitioner’s policy (CMS Ex. 22) required two staff members to conduct a transfer with a Hoyer® lift or how that requirement may have affected her opinion. 

b.  Analysis

The surveyors allege under Tag F309 that Petitioner violated 42 C.F.R. § 483.25(d)(1)‑(2) and (n)(1)‑(3).  CMS Ex. 3 at 55.  The surveyors allege no facts in the SOD that would support a conclusion that Petitioner violated 42 C.F.R. § 483.25(n).  Pursuant to 42 C.F.R. § 483.25(d)(1) Petitioner is required to ensure that “[t]he resident environment remains as free of accident hazards as is possible.”  Pursuant to 42 C.F.R. § 483.25(d)(2) Petitioner is required to ensure that “[e]ach resident receives adequate supervision and assistance devices to prevent accidents.”  42 C.F.R. § 483.25(d)(2).  Petitioner argued at the hearing and in briefs that the surveyors did not actually allege a violation of 42 C.F.R. § 483.25(d)(1).  Tr. 29-41; P. Br. at 25; P. Reply at 9-10.  The surveyors are very clear in the SOD as to the basis for the allegation of noncompliance under Tag F323, i.e., Petitioner “failed to ensure each resident received adequate assistance to prevent accidents for” Resident 1 “who required staff assistance with transfers.”  CMS Ex. 3 at 56-57.  The surveyors did not allege that Petitioner failed to ensure the resident environment was as free of accident hazards, such defective slings on lifts, as possible.  Pursuant to 42 C.F.R. § 498.30, CMS had 12 months, i.e., until May 22, 2018, to reopen and revise its May 23, 2017 initial determination (CMS Ex. 1) and properly notify Petitioner that CMS concluded Petitioner also violated 42 C.F.R. § 483.25(d)(1), but CMS failed to do so.  Therefore, the alleged violation at issue is a

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violation of 42 C.F.R. § 483.25(d)(2).  I conclude that Petitioner did violate 42 C.F.R. § 483.25(d)(2), the violation posed a risk for more than minimal harm and, therefore, was noncompliance.  

There is no question that on March 27, 2017, Resident 1 was transferred by CNA Hinkle.  CNA Hinkle used a Hoyer® lift – the specific type is unknown.  CNA Hinkle made the transfer alone.  During the transfer, when Resident 1 was about two feet above the floor, the lift sling broke and Resident 1 fell to the floor.  Resident 1 suffered a fractured right clavicle due to the fall, which was actual harm.  CMS Ex. 8 at 17; CMS Exs. 9-10, 12; P. Ex. 15 at 3, 7-8; P. Exs. 15-16; P. Ex. 22 at 1.

There is no question that at the time of the fall on March 27, 2017, Resident 1’s last comprehensive assessment indicated that he could be transferred with the active assistance of one person.  P. Ex. 23 at 1.  Resident 1’s care plan did require that he be transferred with a Hoyer® lift but did not require that transfers be by two or more staff.  P. Ex. 14 at 3, 11. 

There is no federal or state statute or regulation cited by the parties that specifies that mechanical or hydraulic lifts must be used to perform transfers only with two or more facility staff present. 

However, CMS placed in evidence CMS Ex. 22.  A document obtained by the surveyors during the survey from someone at Petitioner.  The document states it is a policy regarding mechanical or hydraulic lifts.  Although Petitioner’s administrator denies that she ever used this policy for training or other purposes, she does not specifically deny it was Petitioner’s policy.  Tr. 567-68.  I conclude that CMS Ex. 22 was a policy of Petitioner, even though Administrator Lawson admitted she never used the policy.  Tr. 567.  The policy states that two or three staff members are required to safely operate and accomplish a lift with a mechanical or hydraulic lift.  CMS Ex. 22 at 1.  The policy is consistent with the FDA guidance for safe use of lifts.  CMS Ex. 29 at 6.  Neither the Act nor 42 C.F.R. pt. 483 establish a substantive legal standard that specifies that lifting a long-term care facility resident with a mechanical or hydraulic lift requires two or more staff members.  However, the Board has accepted that “a SNF’s resident care policies may, in appropriate circumstances, be used to judge whether the SNF has complied with [42 C.F.R. pt. 483] regulations that impose general quality-of-care obligations.”  Golden Living Center – Superior, DAB No. 2768 at 23 (2017).  The Board cited numerous examples of cases in which it found it appropriate to use a SNF’s policy to judge whether the SNF was compliant, including Spring Meadows Health Care Ctr.,DAB No. 1966 at 16-17 (2005); The Laurels at Forest Glen, DAB No. 2182 at 18 (2008); Hanover Hill Health Care Ctr., DAB No. 2507 at 6; Perry County Nursing Ctr., DAB No. 2555 at 9 (2014).  In Perry County the Board found that professional standards of quality are presumed to be reflected by a SNF’s policies absent contrary evidence.  DAB No. 2555 at 9.  In this case, I conclude that Petitioner’s policy, as set forth in CMS Ex. 22, reflects

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the professional standard of quality that two or more staff members should be present to perform a resident lift using a mechanical or hydraulic lift, such as a Hoyer® lift.  The standard stated in Petitioner’s policy is consistent with and supported by the FDA guidance for the safe use of such lifts as stated in CMS Ex. 29 at 6.  The is no dispute that in this case CNA Hinkle lifted Resident 1 without another staff member present.  Furthermore, Administrator Lawson admitted in testimony that she never followed the lift policy (CMS Ex. 22) and staff were not trained to that policy.

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(d)(2) and that violation caused Resident 1 to suffer a fractured clavicle, which is actual harm and more than minimal harm.  Petitioner has not rebutted the CMS prima facie showing.

Petitioner’s arguments related to improper survey performance related to Tag F309 (P. Br. at 27-28) are without merit.  My review is de novo and not based on the testimony or the surveyor’s findings stated in the SOD.  Petitioner’s arguments (P. Br. at 27-28) that the citation of noncompliance violates the restriction of 42 C.F.R. § 483.75(i) against imposing sanctions based on good faith efforts of Petitioner’s quality assurance committee to remedy quality deficiencies; or the prohibition of Fed. R. Evid. 407 of admitting or considering evidence of subsequent remedial measures are also without merit.  The citation of noncompliance is based on Petitioner’s failure to ensure compliance with its policy that required it to have at least two staff members present during a transfer with a mechanical or hydraulic lift.  The policy existed at the time of the accident involving Resident 1 on March 27, 2017.  The fact that Petitioner’s quality assurance committee and/or management acted after March 27, 2017, to issue a revised policy is not relevant and not considered in my determination of noncompliance. 

Petitioner also argues that CMS is attempting to hold Petitioner strictly liable for the regulatory violation and Resident 2’s injury.  Strict liability is not an issue in SNF enforcement cases.  Springhill Senior Residence, DAB No. 2513 at 14 (2013); Lifehouse of Riverside Health Care Ctr., DAB No. 2774 at 19 (2017).  There is no evidence that CMS is attempting to impose strict liability upon Petitioner.  P. Br. at 28-29.  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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9.  Petitioner failed to meet its burden to show that CMS’s determination of immediate jeopardy from February 16 through 24, 2017, related to the noncompliance under 42 C.F.R. §§ 483.12 (Tag F223), 483.12(b) (Tag F226), and 483.25 (Tag F309), was clearly erroneous. 

The surveyors alleged that the noncompliance they cited under Tags F223, F226, and F309 involving Resident 2 posed immediate jeopardy.  CMS Ex. 3 at 2, 20, 38.  CMS determined that immediate jeopardy began on February 16 and continued through February 24, 2017.  CMS imposed a CMP of $14,659 for each of the nine days of immediate jeopardy level noncompliance.  CMS Ex. 1 at 2; CMS Ex. 2 at 1.  Petitioner argues that there was no immediate jeopardy.  P. Br. at 23-25.

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 and 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 Srvs.,174 F. App’x 932 (6th Cir. 2006)); Maysville Nursing and Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab. Ctr.– Johnston, DAB No. 2031 at 18-19, 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 Nursing & Rehab. Ctr.–Johnston, 241 F. App’x 76 at 3-4). 

“Immediate jeopardy” under the regulations refers to a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. §§ 488.301, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e); 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s

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provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii). 

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility’s residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, does trigger a right to request a hearing and is subject to review.  42 C.F.R. §§ 488.408(g); 498.3(b)(8), and (13).  Furthermore, the level of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would:  (1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct an NATCEP.  42 C.F.R. § 498.3(b)(14) and (16).  Pursuant to 42 C.F.R. § 498.60(c)(2), in reviewing a CMP, the ALJ must uphold the CMS determination of the level of noncompliance (i.e., the scope and severity), unless it is clearly erroneous.  The phrase “clearly erroneous” is not defined by the Secretary. 

Many appellate panels of the Board have addressed “immediate jeopardy.”17   In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented: 

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031 at 18 (2006), aff’d, Liberty Commons Nursing and Rehab Ctr. — Johnston v.

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Leavitt, 241 F. App’x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.”  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  Daughters of Miriam Center, DAB No. 2067, at 15 (2007).

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

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, 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

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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, 116, 56,179 (Nov. 10, 1994) (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decision in Mississippi Care Ctr. of Greenville; Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  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 Ctr. of Greenville,that panel of the Board stated that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  Id. at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in Mississippi Care Ctr. and other cases does not define the standard.  The “clearly-erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black’s Law Dictionary 269 (8th ed. 2004).  The Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  In re Winship, 397 U.S. 358, 371-72 (1970); 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, 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,

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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.18   Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

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

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

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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 found based on the violations of 42 C.F.R. §§ 483.12 (Tag F223), 483.12(b) (Tag F226), and 483.25 (Tag F309), I have no definite and firm conviction that an error has been committed in declaring immediate jeopardy.  I conclude that Petitioner has failed to meet its burden to show that the determination of immediate jeopardy for the noncompliance cited under Tags F223, F226, and F309 was clearly erroneous.

Resident 2 had a history of constipation and was assessed as being at risk for fecal impaction and bowel obstruction.  Petitioner has not shown that, under any reasonable definition of serious, fecal impaction and bowel obstruction are not serious medical conditions that pose a risk for serious harm or death.  From February 12 through 24, 2017, Petitioner’s staff did not record that Resident 2 had a bowel movement and staff never recorded the amount and consistency of any bowel movement of Resident 2.  Despite the fact that staff did not record a bowel movement for more than three days, interventions required by Resident 2’s care plan were not implemented.  Resident 2 arrived at the hospital on February 24, 2017, with a severe amount of stool in his colon, consistent with being constipated.  Resident 2 was neglected by Petitioner’s staff.  The neglect involved multiple CNAs and other nursing staff who failed to ensure that Resident 2’s bowel care plan was followed.  Petitioner’s noncompliance posed immediate jeopardy to Resident 2.  Whether or not the failure to monitor Resident 2’s bowel functions actually caused him to suffer either a fecal impaction or a bowel obstruction at the facility has no bearing on my analysis.  Petitioner has not presented evidence that there was no likelihood for serious injury, harm, impairment, or death due to its noncompliance. 

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Petitioner argues that because the citations involved “only one resident and one incident,” this situation “is not enough to constitute a ‘pattern’ [of noncompliance], particularly when no other residents were found to have been affected by the allegedly deficient practice.”  RFH at 25; P. Br. at 23.  I am not persuaded by Petitioner’s arguments.  During February 2017, there were multiple instances of failure by multiple staff members on multiple shifts over multiple days from February 12 to 24, 2017 to comply with Resident 2’s care plan.  Accordingly, Petitioner’s noncompliance was not an isolated incident but constituted a pattern.  The surveyors also declared that Petitioner’s deficient practices could potentially have affected up to 32 incontinent residents and placed them at risk for serious injury, harm, or death.  CMS Ex. 3 at 2, 20, and 38-39.  Petitioner has not rebutted that allegation.

Petitioner contends that the surveyors did not follow the SOM’s Appendix Q procedures, which includes CMS guidance to surveyors on how to identify immediate jeopardy.  Petitioner argues that Appendix Q identifies three components for immediate jeopardy to exist, harm, immediacy, and culpability, and, Petitioner asserts none are present here.  P. Br. at 23-25.  Petitioner’s reliance on SOM Appendix Q is misplaced before me.  Appendix Q is a guide for surveyors on 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.

CMS determined that immediate jeopardy existed from February 16 through February 24, 2017.  Petitioner has not shown that the determination or the determination of the duration of immediate jeopardy was clearly erroneous.

10.  A CMP of $14,659 per day from February 16 through 24, 2017, and a CMP of $1,460 per day from February 25, 2017 through May 15, 2017, are reasonable enforcement remedies. 

I have concluded that Petitioner violated 42 C.F.R. §§ 483.12 (Tag F223), 483.12(b) (Tag F226), 483.25 (Tag F309), and 483.25(d)(2) (Tag F323), and that the violations posed a risk for more than minimal harm to facility residents.  I have also concluded that Petitioner has failed to show that the determination of immediate jeopardy for noncompliance with the requirements of 42 C.F.R. §§ 483.12 (Tag F223), 483.12(b) (Tag F226), and 483.25 (Tag F309) during the period February 16 through 24, 2017, was clearly erroneous.

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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).  I conclude that there is a basis for the imposition of an enforcement remedy in this case, i.e., the noncompliance I have concluded existed.  If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that I may:  (1) not set the CMP at zero or reduce it to zero; (2) not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. §  488.438(f) must be considered:  (1) the facility’s history of 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; CarePlex of Silver Spring, DAB No. 1683 at 14–16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

A CMP that is imposed against a facility on a per day basis falls into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The per-day CMP ranges applicable to this case are $6,394 to $20,965 for immediate jeopardy-level deficiencies and $105 to $6,289 for deficiencies that do not constitute immediate jeopardy.  82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017); 45 C.F.R. § 102.3 (Table).

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Petitioner argues that there is no regulatory basis for a CMP, and that the proposed CMP is unreasonable, excessive, and arbitrary.  RFH at 2, 34; P. Br. at 29-30.  In its post‑hearing brief, Petitioner contended that if any CMP is warranted the CMP “should not approach anywhere near $250,000.”  RFH at 34; P. Br. at 30.  Petitioner argues further that CMS did not properly apply the factors established by 42 C.F.R. §§ 488.438 and 488.404.  P. Br. at 29. 

In determining the reasonableness of the proposed CMP, I am to consider the per day amount and number of days of noncompliance, not, as Petitioner argues, the total amount of the CMP.  Century Care of Crystal Coast, DAB No. 2076 at 26 (2007).  Further, my review of the reasonableness of the CMP is de novo and I apply the factors established 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.  I consider the regulatory factors as follows: 

CMS submitted Petitioner’s Certification and Survey Provider Enhanced Reports (CASPER) report, which includes survey findings for the period running from October 2013 through September 2016.  CMS Ex. 25.  According to the report, Petitioner had a history of noncompliance in 2016 under Tag F226 at the “E” scope and severity level.  CMS Ex. 25 at 4.

Petitioner has presented no evidence regarding its financial ability to pay the CMP.

Petitioner’s noncompliance is very serious.  Petitioner neglected Resident 2 by failing to ensure staff followed his care plan.  Petitioner’s noncompliance posed immediate jeopardy for Resident 2 and other residents subject to constipation, bowel obstruction, and impaction that required care and services similar to those specified by Resident 2’s care plan.  In the example of Resident 1, Petitioner failed to provide him with adequate supervision and assistance during a transfer with a mechanical or hydraulic lift.

Petitioner was culpable for its noncompliance, which involved neglect of Resident 2 due to failure to follow the resident’s care plan.

The neglect of Resident 2 posed immediate jeopardy to Resident 2 and other residents with similar conditions and care plans.  The neglect of Resident 2 represented a pattern of noncompliance that involved multiple staff members, over multiple shifts, and multiple days.  Resident 1 suffered actual harm in the form of a fractured clavicle. 

CMS proposed a CMP totaling $248,731 as follows:  $14,659 per day for nine days from February 16 through 24, 2017; and $1,460 per day for 80 days from February 25 through

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May 15, 2017.  The per day CMP of $14,659 proposed for the nine days of immediate jeopardy is above the middle of the authorized range, and I conclude it is reasonable based on my consideration of the regulatory factors.  I conclude that the $1,460 per day CMP proposed for the 80 days of non-immediate jeopardy level noncompliance is at the low end of the authorized range and is reasonable based on the regulatory factors. 

III.  Conclusion

For the foregoing reasons, I conclude that: 

Petitioner was not in substantial compliance with program participation requirements from February 16 through May 15, 2017, due to violations of 42 C.F.R. §§ 483.12 (Tag F223), 483.12(b) (Tag F226), 483.25 (Tag F309), and 483.25(d)(2) (Tag F323), each of which posed a risk for more than minimal harm;

The determination of immediate jeopardy was not clearly erroneous; and

Reasonable enforcement remedies are a CMP of $14,659 per day from February 16 through 24, 2017, and a CMP of $1,460 per day from February 25 through May 15, 2017.

• 1. References are to the Code of Federal Regulations (C.F.R.) as revised effective November 28, 2016, unless otherwise indicated.  81 Fed. Reg. 68,688, 68,697 (Oct. 4, 2016).  In Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), an appellate panel of the Departmental Appeals Board (Board), after reviewing prior Board decisions, expressed a preference for applying the regulations in effect at the time of agency action rather than at the time of the events that were the basis for the agency action, at least in provider and supplier revocation cases.  Other appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted.  Good Shepard Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996).  In this case, the events for which immediate jeopardy was alleged occurred in February 2017, the survey occurred in April 2017, and the CMS initial determination was issued on May 23, 2017.  The regulations with which Petitioner was bound to comply during this period were in the 2016 revision of the C.F.R. as amended effective November 28, 2016.  Effective November 28, 2016, 42 C.F.R. pt. 483, was extensively revised with many of the participation requirements established by the regulations being moved and renumbered.  81 Fed. Reg. 68,688, 68,697.  I conclude that the new regulations effective November 28, 2016, apply under the Board’s rationale in Good Shepherd, Carmel,and the cases cited therein.  The new regulations are published in the 2017 revision of the C.F.R.
• 2. SNFs and NFs are often referred to as long-term care facilities or nursing homes.  Participation of a NF in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.
• 3. Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation similar to those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.
• 4. “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.
• 5. As already noted, CMS extensively revised the regulatory participation requirements in 42 C.F.R. pt. 483, effective November 28, 2016.  81 Fed. Reg. 68,688, 68,697.  However, CMS did not issue its revised CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (available at www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs) that addressed the revised regulations until November 22, 2017 (SOM, rev. 173, eff. Nov. 22, 2017).  The revised SOM changed the numbering of the F-Tags.  Therefore, when the surveyors conducted the survey in this case, the SOM available to the surveyors for guidance did not correlate to the new regulations.  In the SOD, the surveyors cite to the F-Tags from the prior SOM (rev. 168, eff. Mar. 8, 2017) that related to the old regulations.  In the SOD, the surveyors cite the new regulations under the F-Tags from the prior SOM that related to the prior regulations.  Although confusing, I concluded it was unnecessary to send this case back to CMS for correction of the SOD to refer to the new F-Tags from the revised SOM as there is no substantive impact in deciding this case.  The F-Tag generally refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors for identifying compliance or noncompliance.  Whether or not the F-Tags from the prior SOM accurately state CMS policy regarding the new regulations at the time of the survey is not an issue that the parties have raised in this case.  Furthermore, the SOM is not promulgated in accordance with section 1871(a)(1)‑(2) of the Act and does not have the force and effect of law, although the provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM as law, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.  The new regulations and not the SOM control the decision in this case.
  
  Scope and severity (S/S) levels are used by CMS and the state agency 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, chap. 7, § 7400.5.1 (rev. 161, eff. Sept. 23, 2016) (§ 7400.3.1 in the current SOM, rev. 185, eff. Nov. 16, 2018).  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The scope and severity matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
• 6. Facilities are required to conduct comprehensive assessments of residents using resident assessment instruments.  The results of the assessments are recorded in the MDS, which is reported to CMS.  The MDS, when properly completed, is a comprehensive report of a resident’s functional capacity, medical history, and requirements for care and services during the period of the comprehensive assessment.  42 C.F.R. §§ 483.20(b), 483.315.  Capt. McElroy confirmed that there is a seven-day look-back or observation period for assessments used to complete the MDS.  He testified that, during the seven-day look-back period facility staff observes the resident and will typically assess the resident at the highest level of assistance required by the resident during the period.  Tr. 207.  He testified that staff creates a resident’s care plan using the assessments used to complete the MDS.  Tr. 208, 395.  According to Capt. McElroy, in addition to interdisciplinary team members (IDT), other staff may also observe the resident during the assessment period and participate in completing the MDS.  Tr. 208.  He testified that the “care plan itself is the result of that entire assessment process – interdisciplinary team sharing information.”  Tr. 210.
• 7. It appears from the copies of the documents in evidence that they are printed on both sides and there is a space to enter the month and year only on one side of the document.  P. Ex. 17, pages 9 through 16 are in a different order than CMS Ex. 13 pages 13-16.  I rely upon Petitioner’s ordering of the pages in P. Ex. 17 as the correct order of the pages in making these findings.
• 8. In its post-hearing brief, Petitioner claims that there is a typographical error in Resident 2’s dietary records and that his weight loss was much lower.  P. Br. at 8-9.  Petitioner’s argument is not supported by Petitioner’s evidence.  P. Ex. 8; Tr. 569-70.  However, whether or not Resident 2 lost 19 pounds in one month, 27 pounds in three months, or some other amount of weight is not a fact issue that I need to resolve.  The absence of recording of a bowel movement after February 11, 2017, and the probable absence of an actual bowel movement, are the facts of importance.
• 9. The regulatory definition of neglect applicable to SNFs is found in 42 C.F.R. § 488.301, which defines neglect as:  “the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.”  Therefore, Petitioner’s policy is not consistent with the federal regulations, but Petitioner was not cited for this error. 
• 10. The citation is to a revision of the C.F.R. in effect prior to the regulatory revisions effective November 28, 2016.
• 11. Administrator Lawson testified that no problems related to Resident 2’s bowel status were discussed at any meeting she attended through February 22, 2017.  Tr. 533-36.
• 12. Dr. Parker explained that an ileus is a condition where the muscle movement of a section of the small bowel has stopped.  Tr. 463.
• 13. Petitioner’s Administrator, Marie Lawson, testified that no problems related to Resident 2’s bowel status were discussed at any meeting she attended through February 22, 2017.  Tr. 533-36.
• 14. The correct citation to the new regulation in effect at the time of the survey is 42 C.F.R. § 483.75(i).
• 15. CMS placed in evidence a document issued by the Food and Drug Administration (FDA) regarding the use of patient lifts.  CMS Ex. 29.  The document states “[m]ost lifts require two or more caregivers to safely operate lift and handle patients.”  CMS Ex. 29 at 6.  The document does not provide that the use of all lifts requires two or more staff members or identify which lifts do.  In this case, other than the fact that the lift used when Resident 1 fell was a Hoyer®, the specific type of lift used is unknown.  The FDA document does not reflect that it was promulgated as a regulation and I treat it as providing nonbinding guidance that is not enforceable as law.  I conclude that the FDA document does not impose a substantive legal requirement for which Petitioner may be sanctioned for failure to follow the guidance in the document.  Act § 1871(a)(2); Azar v. Allina Health Servs., 587 U.S. ___, 139 S. Ct. 1804 (2019).  However, the FDA guidance is consistent with the policy stated in CMS Ex. 22.
• 16. CMS also placed in evidence an MDS for which the assessment was completed on March 31, 2017.  CMS Ex. 8 at 10.  Therefore, the March 27, 2017 fall occurred during the assessment period and, no doubt affected the assessment.  CMS Ex. 8 at 13 (transfer with physical assistance of two staff was required during the assessment period). 
• 17. Decisions often cited include Lakeport Skilled Nursing Ctr., DAB No. 2435 at 6 (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); Daughters of Miriam Ctr., DAB No. 2067; Britthaven of Havelock, DAB No. 2078 (2007); Koester Pavilion, DAB No. 1750; and Woodstock Care Ctr., DAB No. 1726.
• 18. The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard.  However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.