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                              Schoolcraft Medical Care Facility, DAB CR6150 (2022)
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Schoolcraft Medical Care Facility, DAB CR6150 (2022)








  
  
    

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





Schoolcraft Medical Care Facility,
(CCN:  235147),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-547Decision No. 6150September 7, 2022

        
              
    

      DECISION

Following multiple surveys by the Michigan Department of Licensing and Regulatory Affairs (state agency), the Centers for Medicare & Medicaid Services (CMS) concluded that Schoolcraft Medical Care Facility (Petitioner or facility) was not in substantial compliance with a number of Medicare participation requirements.  CMS determined that several of Petitioner’s deficiencies posed immediate jeopardy to resident health and safety.  As a result, CMS imposed a per-day civil monetary penalty (CMP) of $19,208 from October 16, 2018 through October 18, 2018, and $1,210 per day from October 19, 2018 through January 17, 2019, for a total CMP of $167,734.

For the reasons explained in this decision, I find that Petitioner failed to comply substantially with Medicare participation requirements.  Further, Petitioner failed to prove that CMS’s determination that Petitioner’s noncompliance represented immediate jeopardy to resident health and safety was clearly erroneous.  Finally, I find that the CMP amounts imposed are reasonable.

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I.   Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Manistique, Michigan.  *See* CMS Exhibit (Ex.) 1 at 1.  State agency surveyors conducted an annual recertification survey at Petitioner’s facility from October 16-24, 2018.1  *Id.*  Based on the survey findings, the state agency determined that Petitioner was not in substantial compliance with a total of 27 Medicare requirements,2 including three at the immediate jeopardy level (scope and severity “J”):3  42 C.F.R. § 483.25(d)(1)-(2) (Free of Accident Hazards/ Supervision/Devices); 42 C.F.R. § 483.25(n)(1)-(4) (Bed rails); and 42 C.F.R. § 483.90(d)(3) (Resident Bed)4.  CMS Ex. 1.  The state agency found that Petitioner had

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abated the immediate jeopardy on October 19, 2018, that is, while the recertification survey was in progress.  *Id.*at 41-42, 125, 129.  However, the state agency found that Petitioner remained out of substantial compliance with 27 Medicare participation requirements at lower levels of scope and severity.  CMS Ex. 6 at 1-2.  Among the participation requirements with which Petitioner was found to be noncompliant was 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Treatment/Services to Prevent/Heal Pressure Ulcer) at a scope and severity of “G.”  *Id.*

By letter dated November 8, 2018, the state agency notified Petitioner that CMS had authorized the imposition of a Denial of Payment for New Admissions (DPNA), effective November 24, 2018.  CMS Ex. 5 at 3.  Petitioner timely requested a hearing before an administrative law judge to challenge the deficiency findings that led to the DPNA.  That appeal was docketed as C-19-322 and assigned to me.

The state agency conducted a first revisit survey of Petitioner’s facility from December 19-21, 2018.  CMS Ex. 2 at 1.  The revisit survey concluded that Petitioner continued to be out of substantial compliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Treatment/Services to Prevent/Heal Pressure Ulcer) at a scope and severity of “D” and § 483.90(d)(3) (Resident Bed) at a scope and severity of “E.”5  *Id.*at 1, 6.  The state agency conducted a second revisit on January 25, 2019.  CMS Ex. 8 at 1.  Based on the second revisit, the state agency found Petitioner had returned to substantial compliance effective January 18, 2019.  *Id.*

By letter dated January 15, 2019, CMS notified Petitioner that CMS was imposing a CMP of $19,208 per day for three days beginning October 16, 2018, and continuing through October 18, 2018, and a CMP of $1,210 per day beginning October 19, 2018.  CMS Ex. 6 at 1, 4.  CMS’s January 15 letter also confirmed that a DPNA had become effective November 24, 2018, and that Petitioner would be prohibited from conducting a Nurse Aide Training and Competency Evaluation Program for a period of two years.  *Id.*at 3, 5-6.

By letter dated March 5, 2019, CMS informed Petitioner that, based on the second revisit by the state agency, CMS found that the facility returned to substantial compliance effective January 18, 2019.  CMS Ex. 12 at 1.  Based on Petitioner’s return to substantial compliance, CMS stated that the $1,210 per-day CMP was imposed from October 19, 2018 through January 17, 2019, a total period of 91 days.  *Id.*at 2.  CMS stated that the CMP for the three days of immediate jeopardy totaled $57,624, and the CMP for the 91 days of non-immediate jeopardy noncompliance totaled $110,110.  *Id.*

On March 15, 2019, Petitioner filed a second hearing request to challenge the CMPs imposed in CMS’s January 15, 2019 letter.  Petitioner’s second hearing request was

Page 4

docketed as C‐19‐547 and was assigned to me.  I issued an acknowledgment and prehearing order (Prehearing Order) establishing a briefing schedule and consolidating Docket No. C-19-322 with Docket No. C-19-547.

In accordance with the schedule I set, CMS timely filed a Prehearing Brief and Motion for Summary Judgement (CMS Br.), along with 60 proposed exhibits, including the written declarations of four proposed witnesses.  Petitioner timely filed a Brief and Opposition to CMS’s Motion for Summary Judgment (P. Br.), 39 exhibits, including the written declarations of nine proposed witnesses, a request to cross-examine all four of CMS’s witnesses, and an objection to CMS’s Ex. 60 as irrelevant.  CMS requested to cross-examine four of Petitioner’s witnesses.

I denied CMS’s motion for summary judgment in a ruling issued October 30, 2020.  Thereafter, I convened a telephone prehearing conference with the parties at which I scheduled the case for a hearing.  Prior to the prehearing conference, CMS withdrew its proposed Ex. 60, to which Petitioner had objected.  CMS later moved for leave to supplement its prehearing exchange with its proposed Ex. 61.

On December 16, 2020, I held a hearing by video teleconference and a transcript (Tr.) was made of the proceeding.  In the absence of objection, I admitted into evidence CMS Exs. 1-59, 61, and P. Exs. 1-39.  Tr. at 6-8, 17, 72, 83, 93, 101.6  Counsel for Petitioner cross-examined two state agency surveyors.  Counsel for CMS cross-examined two of Petitioner’s employees and Petitioner’s expert witness.  Following the hearing, the parties filed post-hearing briefs (CMS Post-hrg. Br., P. Post-hrg. Br.) and post-hearing replies (CMS Reply, P. Reply).

II.   Issues

The issues in this case are:

1.   Whether Petitioner failed to comply substantially with the Medicare participation requirement at 42 C.F.R. § 483.25(d)(1)-(2) (Free of Accident Hazards/Supervision/Devices);

2.   Whether Petitioner failed to comply substantially with the Medicare participation requirement at 42 C.F.R. § 483.25(n)(1)-(4) (Bed rails);

3.   Whether Petitioner failed to comply substantially with the Medicare participation requirement at 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Treatment/Services to Prevent/Heal Pressure Ulcer);

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4.   If Petitioner did not comply substantially with Medicare participation requirements, whether CMS’s finding of immediate jeopardy was clearly erroneous; and

5.   If Petitioner did not comply substantially with Medicare participation requirements, whether the per-day CMP amounts are reasonable.

III.   Jurisdiction

I have jurisdiction to hear and decide this case.  Social Security Act (Act) §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (codified at 42 U.S.C. §§ 1320a-7a(c)(2), 1395i-3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).

IV.   Discussion

**A.   Statutory and Regulatory Framework**

The Act sets requirements for SNF participation in the Medicare program.  The Act authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. part 483.

A facility must maintain substantial compliance with program requirements in order to participate in the program.  To be in substantial compliance, a facility’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act (42 U.S.C. § 1395i-3(b), (c), and (d)), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301.

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  When the results of a survey show that a SNF is not in substantial compliance with program participation requirements, the Secretary may impose enforcement remedies such as CMPs.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)); 42 C.F.R. § 488.406.

Page 6

If CMS imposes a CMP based on a noncompliance determination, then the SNF may request a hearing before an administrative law judge to challenge CMS’s determination of noncompliance that led to the imposition of an enforcement remedy.  A SNF may challenge CMS’s finding as to the level of noncompliance only if a successful challenge would affect the range of CMP amounts imposed on the SNF.  Act §§ 1128A(c)(2), 1819(h)(2)(B)(ii) (42 U.S.C. §§ 1320a‐7a(c)(2), 1395i‐3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g)(1), 488.330(e), 488.434(a)(2)(viii), 498.3(b)(13)-(14); *see also* 5 U.S.C. §§ 554, 556.  Further, where a challenge to the level of noncompliance is permitted, CMS’s determination as to the level of noncompliance must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

In a hearing before an administrative law judge, CMS must make a prima facie case that the SNF failed to comply substantially with federal participation requirements.  If CMS makes a prima facie case, the burden of persuasion shifts to the SNF, which must prove substantial compliance by a preponderance of the evidence.  *Hillman Rehab. Ctr.*, DAB No. 1611 at 8 (1997), *aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health & Human Servs.*, No. 98-3789 (GEB) (D. N.J. May 13, 1999); *see* *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).

**B.   Findings of Fact, Conclusions of Law, and Analysis**

***1.   Petitioner did not substantially comply with the Medicare participation requirements at******42 C.F.R. § 483.25(d)(1)-(2) (Free of Accident Hazards/Supervision/Devices) and 42 C.F.R. § 483.25(n) (Bed rails).***

***a.   I find the following facts by a preponderance of the evidence.***

**Resident 57.**7****At the time of the incidents at issue, Resident 57 (R57) was a 71-year-old man who had resided at Petitioner’s facility since November 1, 2017.  CMS Ex. 15 at 2, 3; *see also*CMS Ex. 16 at 23.  R57’s diagnoses included Alzheimer’s disease, anoxic brain damage, hypertension, hyperlipidemia, diabetes mellitus, chronic obstructive pulmonary disease, chronic kidney disease, adult failure to thrive, and pressure ulcers.  CMS Ex. 15 at 18-19; *see also*CMS Ex. 16 at 23; CMS Ex. 51 at 1.  R57 had a Brief

Page 7

Interview for Mental Status (BIMS) score of “8,” indicating that his cognition was on the borderline between moderately and severely impaired.8  CMS Ex. 15at 6.  R57 had a history of falls and required the extensive assistance of two staff for bed mobility and transfers.  *Id.*at 11, 22; *see also*CMS Ex. 16 at 3.  R57 was incontinent of bowel and bladder, which contributed to his high risk for skin breakdown.  CMS Ex. 15 at 17; *see also*CMS Ex. 16 at 9, 26.  R57’s care plan documented that he had a Braden Score of 12, which placed him at high risk of developing pressure ulcers.  CMS Ex. 16 at 9.  Accordingly, the care plan called for R57 to have an alternating low air loss mattress for pressure relief while in bed.  *Id*.  R57’s bed was also equipped with bilateral bed rails.  CMS Ex. 1 at 45, 66-67; *see also*Tr. at 32-33.

**Incidents involving R57’s bed, mattress, and bed rails.**On August 5, 2018, at approximately 11:00 pm, Petitioner’s facility experienced a brief power failure.  CMS Ex. 20 at 4-5; P. Ex. 32 at 2 (¶ 6); *see also*P. Br. at 4.  R57’s air mattress deflated, apparently due to the power failure.  CMS Ex. 1 at 43, 46; CMS Ex. 20 at 4; *see also*P. Ex. 32 at 2 (¶¶ 9-11).  Shortly after the power failure, one of Petitioner’s certified nurse aides (CNAs), A.M.,9 checked on R57 and found him partially out of bed, “with his head against the grab bar [bed rail] and his feet on the fall mat.”  P. Ex. 32 at 2 (¶ 7).  CNA A.M. called another CNA, F.H., to stay with R57 while A.M. summoned a nurse.  *Id.*(¶ 12).  One of Petitioner’s nurses, N.W.,10 responded.  *Id.* Nurse N.W. documented that, when she entered the room, she found R57 “wedged in between his mattress and his side rail.”  CMS Ex. 20 at 5.  She elaborated that R57 was “in between bed and arm rail” with his “feet on floor, arms wedged in between arm rail and bed . . . head to the side with his head resting on the bed.”  *Id.* at 4.  Two staff members assisted R57 back into bed and turned his air mattress back on.  *Id.*  N.W. assessed R57.  She observed redness

Page 8

on R57’s left cheek, bilateral ribs, left forearm, bilateral knees, and left thumb.  *Id.*  N.W. reported the incident to Petitioner’s Administrator and director of nursing (DON).  *Id.*  She implemented checks of the resident at 15-minute intervals and wrote a note requesting that the nurse practitioner evaluate the resident during rounds.  *Id.* N.W. documented her observations and actions at or about 11:45 pm (23:45) on August 5, 2018.  *Id.*

The form N.W. completed documenting the August 5, 2018 incident includes a section headed “Follow up Report.”  *Id.*at 6.  That section includes a checklist of items, such as “Conclusion,” “Root Cause,” “Report and investigation completed in full,” and “Care plan updated,” each of which is marked “N/A.”  *Id.*at 6.  I infer from the form that Petitioner did not investigate why R57’s mattress deflated on or after August 5, 2018.  *See*CMS Ex. 1 at 45-46.  Petitioner does not contend that it did so.  *See, e.g.,*P. Br. at 5 (“At the time of the August 5, 2018 incident, there was no indication . . . the . . . malfunction was caused by anything other than the power outage.”).  Similarly, nothing in the record suggests that Petitioner’s staff updated R57’s care plan in response to the incident.  *See*CMS Ex. 16 at 30 (care plan for fall risk lists fall on 8/5/18, but no interventions at or around that date); *see also*CMS Ex. 1 at 44-45.

On September 2, 2018, at approximately 2:20 am, CNA F.H. went into R57’s room and found him “between his bed and the wall.”  CMS Ex. 22 at 2.  F.H. reported that the “lower part of [R57’s] body was on the bed” and the “upper part [of his body was] in between [the] wall and bed.”  *Id.* The CNA notified one of Petitioner’s registered nurses, T.S., who responded and completed an incident report.  CMS Ex. 20 at 1-3.  In a written statement, Nurse T.S. reported that, according to the CNA, R57 “was laying [with] his head between the wall and the mattress.”  CMS Ex. 22 at 1; *see also*CMS Ex. 20 at 1.  T.S. stated that R57 had an abrasion on his left forehead and that there was blood on the wall.  CMS Ex. 22 at 1; *see also*CMS Ex. 20 at 1.  Under the heading, “Immediate Actions Taken,” T.S. wrote that she placed a pillow between R57 and the wall.  CMS Ex. 20 at 1.  She additionally informed Petitioner’s Administrator “about the possibility of mattress malfunction” and “possibility of removing the side rail that is against the wall so that there is no gap there in the future.”  *Id.*

Nurse T.S. completed an incident report for the September 2, 2018 incident at or about 3:23 am.  *Id.*at 1-3.  As was the case with the incident report form from the August 5, 2018 incident, the form T.S. completed documenting the September 2, 2018 incident marked the follow-up items, such as “Conclusion,” “Root Cause,” “Report and investigation completed in full,” and “Care plan updated,” as “N/A.”  *Id.*at 3.  R57’s care plan was not updated, and no new interventions were initiated following these incidents.  CMS Ex. 1 at 44-45.

Petitioner’s Maintenance Supervisor, J.W., testified that “at the time of the survey, and at all times relevant prior to the survey, Resident 57’s bed [frame] was a Drive Prime,

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model P902.”  P. Ex. 33 at 2 (¶ 6).  From early 2018 until at least September 2, 2018, R57’s bed was equipped with a Patriot A.P.M. II mattress.  P. Ex. 34 at 3 (¶ 13); *see also*P. Ex. 35 at 3-4 (¶¶ 16, 18).  On or about September 4, 2018, Petitioner replaced R57’s Patriot air mattress with an Invacare model MA65.  P. Ex. 34 at 3 (¶ 16).  Both the Patriot air mattress and the Invacare air mattress are compatible with the Drive Prime bed.  P. Ex. 37 at 3 (¶ 9).  R57’s air mattress was not plugged into an emergency backup outlet during either incident.  CMS Ex. 1 at 47.

**State agency recertification survey.**  The state agency performed an annual recertification survey of Petitioner’s facility between October 16 and October 24, 2018.  CMS Ex. 1.  State agency surveyor Ruth Keller (Surveyor Keller) was a member of the survey team and was present at Petitioner’s facility each day of the survey.  CMS Ex. 55 at 2 (¶ 5).  During the survey, she reviewed records, observed residents and staff, gathered records, and conducted interviews.  *Id.* Surveyor Keller testified that the text of the statement of deficiencies for the recertification survey (CMS Ex. 1) contains true and accurate summaries of her record review, observations, and staff interviews.  CMS Ex. 55 at 2(¶ 6).  Unless I explicitly state otherwise, I find it more likely than not that the statements and observations in the statement of deficiencies for the recertification survey accurately record what Surveyor Keller observed and heard during the survey.

On October 17, 2018, Surveyor Keller observed R57’s bed.  CMS Ex. 55 at 2 (¶ 7); *see also*Tr. at 32-33; CMS Ex. 1 at 45.  R57 was not in his bed at the time.  Tr. at 32.  She observed an alternating pressure low air loss mattress on the bed.11  CMS Ex. 1 at 45.  She noted bed rails (“mobility bars”) on both sides of the bed.  The bed rail on the right side (as observed from the foot of the bed) extended approximately six inches from the mattress.  *Id.*  The left side rail was against the wall.  *Id.*  The mattress was plugged into a regular electrical outlet and not an emergency power outlet.  *Id.*

On October 18, 2018, Surveyor Keller observed that R57’s bed had been moved so that the power cord for the air mattress would reach the emergency power outlet.  CMS Ex. 55 at 3 (¶ 8).  The power cord did not reach the emergency power outlet from the bed’s position on October 17, 2018.  *Id.*(¶ 7).  In addition, the bed rail that would have been against the wall had been removed.  *Id.*(¶ 8).  Only the bed rail on the exit side of the bed remained.  *Id.* Also on October 18, 2018, Surveyor Keller observed a “significant gap between Resident 57’s air mattress and the exit side bed rail.”  *Id.*(¶ 9). She estimated the gap to be six inches wide.  *Id.* The gap was present without compressing the air mattress.  *Id.* The air mattress did not fit tightly or firmly against the bed rail.  *Id.*

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During an interview on October 18, 2018, Surveyor Keller asked Petitioner’s DON if R57’s care plan was updated following the mattress-failure incidents.  CMS Ex. 1 at 45.  The DON stated “. . . Absolutely we should have done these things (interventions to prevent future entrapment) after the first incident.”  *Id.* (Parentheticals and ellipsis in original).  The following day, October 19, 2018, Surveyor Keller asked the DON what the facility did to prevent further entrapment of R57 after the August 5 and September 2 incidents.  CMS Ex. 1 at 45-46.  The DON stated, “We didn’t do anything for him.  There is nothing in his care plan . . . .”  *Id.*

Also on October 19, 2018, Surveyor Keller asked Petitioner’s wound care nurse, LPN A.R. (identified in the statement of deficiencies as “LPN C”) what had occurred with R57’s air mattress during the August 5 and September 2 incidents.  Nurse A.R. told Surveyor Keller that, on August 5, 2018, R57’s air mattress had deflated after the power outage.  *Id.*at 46; *see also*CMS Ex. 14 at 1.  Nurse A.R. added, “There was no safety feature on that mattress.”  CMS Ex. 1 at 46.  Nurse A.R. stated that the September 2 incident was due to a mattress malfunction.  *Id.*at 46-47.  She elaborated, “It was the same older mattress . . . I think it was finally at its end.”  *Id.*at 47.

During the same interview, Surveyor Keller asked Nurse A.R. about Petitioner’s bed rail policy.  CMS Ex. 1 at 65.  Nurse A.R. stated that she would usually ask the DON for bed rail approval.  *Id.* She further reported that she had “no idea” who decides which bed rails are installed on which beds or who measures the bed rails to insure an appropriate fit.  *Id.*  According to A.R., “Nobody is really in charge of that (bed assessment and measuring).  We used to have a small handout about bed rails, but I haven’t seen that for a while.”  *Id.*  (Parenthetical in original).  In a separate interview, Petitioner’s DON told Surveyor Keller that Petitioner had not measured beds and bed rails to assure proper fit for “about two and a half years.”  *Id.*at 63.  The DON further confirmed that there was no bed rail policy at the facility.  *Id.*  On October 23, 2018, Surveyor Keller reviewed job descriptions for Petitioner’s DON, Assistant DON, Maintenance Supervisor, and wound care nurse with a human resources employee.  *Id.*at 65-66.  None of the job descriptions documented that any of these staff members was responsible for bed and bed rail measurements or ensuring compatibility between bed rails, mattresses, and bed frames.  *Id.*at 66.  During the survey, Petitioner’s staff did not provide Surveyor Keller with documentation that staff members had evaluated resident beds, mattresses, or bed rails for entrapment risks.  *Id.*at 46-48, 62-68.  On October 24, 2018, Petitioner’s Quality Assurance Nurse (RN/QA) also stated in response to a question that, despite being responsible for new resident assessments, the RN/QA had never assessed whether bed rails were appropriate during the year she had worked at the facility and did not know who, if anyone, did make that assessment.  *Id.*at 66.

Also on October 24, 2018, Surveyor Keller asked Petitioner’s RN/QA and a Nurse Consultant whether the facility had a signed consent form from R57 or his responsible

Page 11

party related to his bed rails.  *Id.*Both staff members stated that they could find no record of a consent form in R57’s medical record.  *Id.*at 66-67.  Petitioner offered a “Siderail Risk and Consent” form, dated October 20, 2018, indicating that one of Petitioner’s nurses12 obtained “verbal consent” for R57’s bed rails from the resident’s daughter on that date.  CMS Ex. 21 at 1.  I infer from these statements and this document that Petitioner had no written record that it obtained consent to install R57’s bed rails prior to October 20, 2018.

On October 24, 2018, Surveyor Keller interviewed Nurse T.S. (identified in the statement of deficiencies as RN U).13  *Id.*at 47; *see also*CMS Ex. 14 at 1.  T.S. told the surveyor, “I don’t think they (facility staff) did anything to the bed after the first entrapment.”  CMS Ex. 1at 47 (parenthetical in original).  T.S. further stated that she told Petitioner’s Administrator to “look into the matter because [R57] had an alternating air mattress and if he was too far to one side, the mattress filled up with air on the other side and basically booted him out of the bed . . . .”  *Id.*(ellipsis in original).

On October 24, 2018, the surveyor interviewed CNA F.H. by telephone.14  CMS Ex. 1 at 47; CMS Ex. 22 at 3.  F.H. confirmed that he was working the night shifts on both occasions when R57 became entrapped.  CMS Ex. 1 at 47; *see also*CMS Ex. 22 at 3.  CNA F.H. described that, on September 2, 2018, R57’s head “got stuck” between the bed rail and the bed.  CMS Ex. 1 at 47; *see also*CMS Ex. 22 at 3.

**Testimonial evidence.**  Surveyor Keller testified that if she is concerned about the size of a gap between a resident’s mattress and bed rail or bed frame, it is not her practice as a surveyor to measure the gap herself.  Tr. at 43.  Instead, she estimates the size of the gap using her hand as a guide.  *Id.*at 44.  She then brings her concern to the attention of facility staff and gives them the opportunity to measure the gap, if they disagree with her estimate.  *Id.*

In the statement of deficiencies, Surveyor Keller wrote that Petitioner’s DON and Maintenance Supervisor, J.W., agreed with her observation of a six- to eight-inch gap between R57’s mattress and bed rail.  CMS Ex. 1 at 45, 46.  However, in his written direct testimony, J.W. denied that the gap was six inches, although he did not provide a

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measurement of his own.  P. Ex. 33 at 2‐3 (¶¶ 12, 15).  In an unsworn statement dated November 18, 2018, J.W. similarly stated that he did not agree with the surveyor’s estimate of a six-inch gap but went on to assert that he measured the gap between the bed rail and the mattress at four inches.  CMS Ex. 61.

Petitioner offered a series of photographs as Exhibits A and B to J.W.’s written direct testimony.  J.W. identified Exhibit A as depicting a Drive Prime Bed with an Invacare MA65 mattress that “demonstrate[s] how the bed, grab bar and alternating pressure mattress [of R57 were] configured at the time I spoke with the surveyor on October 18, 2018.”  P. Ex. 33 at 2 (¶ 8).  However, on cross-examination, J.W. testified that he did not know who had taken the photographs in Exhibit A or when they were taken.  Tr. at 95.  Further, counsel for Petitioner explicitly stated that the photographs were demonstrative of “the manufacturer recommended spacing for bedrails” and were not intended as “fact-based or contemporaneous examples of the beds.”  *Id.*at 112.  I therefore accord the photographs in Exhibit A no weight.15

I also accord less weight to J.W.’s testimony and more weight to Surveyor Keller’s testimony on this point.  I find that J.W.’s testimony is entitled to less weight because his written direct testimony is equivocal and is inconsistent with his prior written statement.  In his written direct testimony he states that, in his conversation with the surveyor, he did not agree with her estimate of the gap, that he was “not sure of the distance,” and that he later determined “it was not possible that the space between the mattress and [bed rail] could have been 6 inches.”  P. Ex. 33 at 3 (¶¶ 12, 14).  J.W.’s written testimony avoids stating what measurement he took, if any, to determine that the gap could not have been six inches.  Further, his prior written statement states that he told the surveyor “it could be a possibility” that the gap was six inches.  CMS Ex. 61.  The statement continues, “upon measuring the difference, I learned that the distance [between the bed rails and the mattress] is in fact four inches.”  *Id.* J.W.’s statement was dated November 18, 2018, which was considerably closer in time to the events in question than his written direct testimony, which he signed on July 29, 2019.

I therefore find it is more likely than not that when Surveyor Keller discussed R57’s bed rails and mattress with J.W. on October 18, 2018, there was a gap visible between the inflated mattress and the bed rail.  Surveyor Keller stated that she estimated the gap to be six inches.  J.W. stated he was unsure, but that it was possible.  He did not offer to measure the gap himself.  Surveyor Keller interpreted J.W.’s statement as agreement with her estimate.  Given that no one measured the gap that existed on October 18, 2018, I cannot make a definitive finding as to the size of the gap.  However, I find it is more

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likely than not that the gap was at least four inches and was likely between four and six inches.  I find it unlikely that the gap was between one and two inches as depicted in P. Ex. 14 and Exhibit A to P. Ex. 33.

Petitioner offered the expert testimony of Matthew F. Baretich, Ph.D., a certified clinical engineer.  P. Ex. 37.  Dr. Baretich testified that, in his professional opinion, “a resident cannot become entrapped against a deflated mattress because there is no pressure being exerted by [the] deflated mattress . . . to prevent the resident from moving, or causing any risk of asphyxiation.”  *Id.*at 4 (¶ 11).  Dr. Baretich relied on the pictures in P. Ex. 14 in forming this opinion.  *Id.*at 2 (¶ 6.g); *see also*Tr. at 104.  I accord limited weight to Dr. Baretich’s opinion because, as is true of the photographs in Exhibit A to P. Ex. 33, the pictures in P. Ex. 14 do not accurately reflect the configuration of R57’s bed, mattress, and bed rails at the time of the incidents in August and September of 2018, nor do they reflect the configuration at the time of the survey in October 2018.

Petitioner provided sworn declarations that the beds, mattresses, and bed rails in the facility were evaluated for entrapment risks (P. Ex. 34 at ¶ 8; P. Ex. 33 at ¶ 5; P. Ex. 35 at ¶ 8), but the only documentation of bed rail measurements is dated October 19, 2018.  P. Ex. 4.  I therefore find it more likely than not that Petitioner’s staff performed the bed rail measurements and obtained the informed consent as part of the facility’s action plan to abate the finding of immediate jeopardy, and not prior to that time.  *See*CMS Ex. 1 at 67.  Further, Surveyor Keller testified that, at the time of the recertification survey, R57’s medical record did not include any written assessment that bed rails were appropriate for him.  Tr. at 65.

Petitioner’s Administrator, T.L., stated in her written direct testimony that R57’s “daughter, his representative under power of attorney, visited [R57] frequently and was aware of and affirmatively consented to the grab bar installed on [R57’s] bed and to its use.”  P. Ex. 34 at 3 (¶ 17).  I accord this statement limited weight because it does not include details about the circumstances under which R57’s daughter allegedly consented.  For example, Administrator T.L. does not explain when R57’s daughter consented or who among Petitioner’s staff obtained her consent, nor whether that staff member explained the risks and benefits of bed rails to her.  Further, as I have described above, the only documentary evidence that R57’s daughter consented is dated October 20, 2018.

***b.   Petitioner failed to ensure that R57’s bed, mattress, and bed rails were******free of accident hazards.***

The quality of care regulation, 42 C.F.R. § 483.25, states generally that, “Based on the comprehensive assessment of a resident, the facility must ensure that residents received treatment and care in accordance with professional standards of practice, the comprehensive person-centered plan, and the resident’s choices . . . .”  Subsection

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483.25(d) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

(d) *Accidents*.  The facility must ensure that—

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

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

In ensuring a facility is as free from accident hazards as possible, a facility “must determine whether any condition exists in the environment that could endanger a resident’s safety.”  *Me. Veterans’ Home – Scarborough*, DAB No. 1975 (2005).  While a facility need not “do the impossible,” it must “do everything in its power to prevent accidents.”  *Asbury Ctr. at Johnson City*, DAB No. 1815 (2002).

As I have found above, CMS presented credible evidence that, at the time of the recertification survey, Petitioner did not have an appropriate system in place to ensure resident beds were free from entrapment hazards.  In addition, after R57 was entrapped between his mattress and bed rail on August 5, 2018, Petitioner failed to investigate what caused the incident and did not make any changes to R57’s bed/mattress or add any new interventions to his care plan to prevent a recurrence.  Then, on September 2, 2018, R57 again became entrapped between his bed and the wall.  I find that these facts are more than sufficient to establish a prima facie case that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(d)(1)-(2).  Accordingly, the burden of persuasion shifts to Petitioner to demonstrate by a preponderance of the evidence that it complied substantially with 42 C.F.R. § 483.25(d)(1)-(2).  *Hillman*, DAB No. 1611 at 8.  I conclude that Petitioner has failed to meet that burden.

Petitioner does not dispute that R57’s air mattress deflated on August 5 and September 2, 2018.  Nor does Petitioner dispute that on both occasions, after R57’s mattress deflated, Petitioner’s staff found R57 partially out of his bed and that he was unable to free himself and return to bed without the assistance of staff.  Nevertheless, Petitioner argues R57 was not entrapped or injured because of the incidents and, accordingly, it was not out of compliance with 42 C.F.R. § 483.25(d)(1)-(2).  P. Br. at 9-10.  Petitioner’s argument that R57 was not entrapped is purely semantic and I reject it.

Petitioner states that none of the incident reports specifically uses the word “entrapped.”  *Id*.  Even accepting that the word entrapped does not appear in either incident report, this is not dispositive of whether Petitioner complied substantially with the regulation, which itself does not reference entrapment.  Instead, the regulation requires facilities to ensure that the resident environment is as free of accident hazards as is possible.  In the present case, Petitioner must show that it did everything it could to ensure that R57’s bed, air mattress, and bed rails did not create an accident hazard.  Certainly, if the configuration

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of his bed, mattress, or bed rails placed R57 at risk of entrapment, Petitioner would be out of compliance.  Appellate decisions of the Departmental Appeals Board (DAB) have consistently held that the failure to ensure resident beds are free from entrapment hazards, including failure to develop and implement an effective system to ensure resident beds are free from entrapment hazards or to properly investigate and address known entrapment hazards, violates 42 C.F.R. § 483.25(d)*.*  *Good Samaritan Ctr.*, DAB No. 1844 at *5 (2002); *Me. Veterans’ Home – Scarborough*, DAB No. 1975 at *5 (2005).16, 17

The U.S. Food and Drug Administration (FDA) defines entrapment as “an event in which a patient/resident is caught, trapped, or entangled in the space in or about the bed rail, mattress, or hospital bed frame.”  CMS Ex. 59 at 5-6.  The FDA further warns that, “Patient entrapments may result in deaths or serious injuries.”  *Id*.  I find by a preponderance of the evidence that R57 was entrapped as the FDA defines the term.

In the present case, the Incident Report for the August 5, 2018 incident states that R57 was “wedged in between his mattress and the side rail of his bed” and that he was found “in between bed and arm rail/feet on floor, arms wedged in between arm rail and bed, head to the side with his head resting on the bed.”  CMS Ex. 20 at 5.  Similarly, the Incident Report for the September 2, 2018 incident states R57’s “upper body [was] between the wall and the mattress” and “found [R57 between] bed and wall, lower part of his body was on the bed, upper part of his body was between wall and bed.”  *Id.* at 1.  According to an interview with the staff member who found R57 on September 2, the resident’s head “got stuck.”  CMS Ex. 1 at 47; *see also*CMS Ex. 22 at 3.  Accordingly, R57 was entrapped because he was caught or entangled in the space in or about the bed rail and mattress on one occasion and between the bed and the wall on the other occasion.  In each instance, R57 was unable to free himself without assistance.

In contending that R57 was not entrapped, Petitioner relies on the testimony of CNA A.M., who discovered R57 after his mattress deflated on August 5, 2018.  CNA A.M. stated that R57 was “on the side of the bed, with his head against the grab bar [bed rail] and his feet on the fall mat.”  P. Ex. 32 at 2 (¶ 7).  Nevertheless, CNA A.M. opined that R57 “was not entrapped.”  *Id.*  At the hearing, CNA A.M. further testified that she did not

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believe R57 was entrapped because her understanding of “entrapment” meant “basically to where I would feel like [the resident] would be endangered at any moment.”  Tr. at 86.

Petitioner has presented no evidence or argument that CNA A.M.’s opinion is entitled to any deference based on her training or experience.  Moreover, as CMS correctly observes, the fact that an able-bodied person, such as CNA A.M., did not believe R57 was entrapped or in danger fails to account for the fact that R57’s mobility was limited and he was cognitively impaired.  *See*CMS Post-hrg. Br. at 15.  As the *Good Samaritan*decision points out, “simple and immediate self-help extrication from these gaps was not an option available to everyone.”  DAB No. 1844 at *7.  R57 was diagnosed with Alzheimer’s disease and required the assistance of two persons for bed mobility and transfers.  *See*CMS Ex. 15 at 11, 18.  These factors make it more likely than not that R57 would be entrapped in circumstances where an able-bodied person might not be entrapped. *See Good Samaritan*, DAB No. 1844 at *7 (a resident is entrapped if the resident “needed assistance to escape from the gaps” in the bed rails).  I therefore accord no weight to CNA A.M.’s opinion that R57 was not entrapped.

For similar reasons, I accord little weight to the opinion of Dr. Baretich, Petitioner’s expert.  Dr. Baretich testified that, in his professional opinion, “a resident cannot become entrapped against a deflated mattress because there is no pressure being exerted by [the] deflated mattress . . . to prevent the resident from moving, or causing any risk of asphyxiation.”  P. Ex. 37 at 4 (¶ 11).  I do not accept this conclusion because it is founded on the assumption that a resident, such as R57, entangled in a bed with a deflated air mattress, is able to move independently to free himself.  As I have just explained, R57 was not independent with bed mobility; therefore, he could not move by himself, regardless of whether the deflated mattress was exerting pressure to hold him in place.  In summary, I find that R57 could – and did ‒ become entrapped in the circumstances presented here.

Petitioner next argues that the August 5, 2018 and September 2, 2018 incidents were unavoidable and unforeseeable malfunctions of R57’s mattress.  P. Br. at 10-12.  I reject this argument because, prior to September 2, 2018, Petitioner did not take affirmative steps to determine whether the air mattresses, beds, and bed rails it had installed in its facility (including R57’s) were safe and appropriate for its residents.  The decision in *Me. Veterans’ Home - Scarborough* holds that a facility’s failure to routinely assess resident beds/mattresses/bed rails for entrapment hazards demonstrates substantial noncompliance with 42 C.F.R. § 483.25(d)(1)-(2).  DAB No. 1975 at *4-8.  Here, Petitioner’s argument that the problems with R57’s air mattress were unforeseeable rings hollow when Petitioner failed to take steps that might have revealed that the mattress was defective.

The recertification survey found that Petitioner’s staff had not inspected beds and bed rails in over two years.  CMS Ex. 1 at 46.  Petitioner has not rebutted this finding.  Instead, Petitioner’s evidence shows R57’s air mattress was replaced and other beds were

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inspected *after* the September 2, 2018 incident.  P. Ex. 33 at 1, 3 (¶¶ 5, 15); P. Ex 34 at 2, 3 (¶¶ 8, 11); P. Ex. 35 at 2-3 (¶ 10).  Moreover, even if I were to assume that the August 5, 2018 incident was unforeseeable ‒ a finding I do not make – the fact that R57 was entrapped during the August 5 incident put Petitioner on notice of an issue with R57’s mattress and the related entrapment hazard, which it failed to investigate or remedy, leading to a second mattress malfunction and entrapment less than a month later.

Next, Petitioner argues that R57’s mattress, bed, and bed rails were all compatible and installed appropriately to manufacturer specifications.  P. Br. at 10.  From this, Petitioner would have me conclude that it complied substantially with 42 C.F.R. § 483.25(d)(1)-(2).  I disagree.  Under the federal regulations, long term care facilities must do more than merely follow manufacturer guidelines.  As applicable here, 42 C.F.R. § 483.25(d)(1)-(2) requires that a facility “do everything in its power to prevent accidents.”  *Asbury Ctr. at Johnson City*, DAB No. 1815.  As I have just explained, the regulations impose on facilities the duty to regularly inspect beds, mattresses, and bedrails, if applicable, for entrapment risks.  *Me. Veterans’ Home – Scarborough,*DAB No. 1975.  Petitioner failed to conduct inspections and R57 became entrapped in his bed and bed rails twice within thirty days.  Thus, Petitioner did not do everything in its power to prevent R57’s accidents.

Similarly, Petitioner did not take the relatively simple step of plugging R57’s air mattress into an emergency outlet.  Petitioner counters that its failure to plug R57’s mattress into an emergency outlet was consistent with the manufacturer’s specifications and therefore was not a deficient practice.  P. Post-hrg. Br. at 4.  I find Petitioner’s argument unpersuasive.  The fact that a manufacturer does not require the use of an emergency outlet does not relieve a facility of its duty to “do everything in its power to prevent accidents.” *Asbury Ctr. at Johnson City*, DAB No. 1815.

Petitioner’s noncompliance caused actual harm to R57 (an abrasion to his forehead) and had the potential to cause much more serious harm.  For all these reasons, I find that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(2).

***c.   Petitioner failed to assess R57’s risk of entrapment and failed to obtain informed consent prior to installing bed rails.***

42 C.F.R. § 483.25(n) states:

*Bed rails*.  The facility must attempt to use appropriate alternatives prior to installing a side or bed rail.  If a bed or side rail is used, the facility must ensure correct installation, use, and maintenance of bed rails, including but not limited to the following elements.

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1.   Assess the resident for risk of entrapment from bed rails prior to installation.

2.   Review the risks and benefits of bed rails with the resident or resident representative and obtain informed consent prior to installation.

3.   Ensure that the bed’s dimensions are appropriate for the resident’s size and weight.

4.   Follow the manufacturer’s recommendations and specifications for installing and maintaining bed rails.

Petitioner failed to prove that its staff assessed R57 to determine if he was at risk of entrapment prior to installing bed rails on his bed.  Further, I find by a preponderance of the evidence that Petitioner did not obtain the informed consent of R57 or his responsible party prior to installing the bed rails.  Thus, Petitioner failed to comply substantially with 42 C.F.R. § 483.25(n).

During the recertification survey, Petitioner’s RN/QA acknowledged that Petitioner lacked a system for evaluating whether a particular bed, mattress, and bed rail configuration is appropriate for a resident.  CMS Ex. 1 at 66 (RN/QA stated, “I don’t know who assesses that.  I don’t think I have ever done side rail measurements here.”).  This is consistent with Surveyor Keller’s testimony that she found no documentation in R57’s medical record that the facility had evaluated the risks and benefits of installing bed rails on his bed.  Tr. at 65.

Petitioner offered testimony that its staff inspected resident beds.  P. Ex. 33 at 1, 3 (¶¶ 5, 15); P. Ex. 34 at 2, 3 (¶¶ 8, 11); P. Ex. 35 at 2-3 (¶ 10).  However, the testimony establishes only that facility beds were inspected *after* the September 2, 2018 incident involving R57 (and after the recertification survey had begun).  The only documentation of bed rail measurements Petitioner produced is dated October 19, 2018.  P. Ex. 4.  I therefore find it is more likely than not that Petitioner did not conduct an assessment to determine whether R57 was at risk of entrapment prior to installing his bed rails as required by 42 C.F.R. § 483.25(n)(1).

The evidence similarly fails to establish that Petitioner’s staff obtained informed consent before installing R57’s bed rails.  When asked during the survey if Petitioner’s records included a signed consent for R57’s bed rails, two of Petitioner’s staff responded “no.”  CMS Ex. 1 at 66.  Neither Petitioner’s staff nor the surveyor found a consent form for bed rails in R57’s medical file.  CMS Ex. 1 at 66‐67.  Petitioner counters that R57’s daughter/Power of Attorney consented to Petitioner’s installing bed rails on R57’s bed.  P. Br. at 13; P. Post-hrg. Br. at 6; P. Reply at 5.  As support for these assertions, Petitioner relies on the written direct testimony of Petitioner’s Administrator, T.L.  *See* P. Ex. 34 at ¶ 17 (“Resident 57’s daughter, his representative under power of attorney,

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visited Resident 57 frequently and was aware of and affirmatively consented to the grab bar installed on Resident 57’s bed.”).

I find Administrator T.L.’s written testimony insufficient to establish that Petitioner obtained informed consent for R57’s bed rails prior to installation as required by 42 C.F.R. § 483.25(n)(2).  Administrator T.L. testified that R57’s daughter was aware that R57 had bed rails installed on his bed and that she consented.  P. Ex. 34 at 3 (¶ 17).  Petitioner produced a form, titled “Siderail Risk and Consent,” indicating that one of Petitioner’s nurses obtained “verbal consent” for bed rails from R57’s daughter.  CMS Ex. 21 at 1.  The form is dated October 20, 2018.  *Id.* I infer from this document that, prior to October 20, 2018, Petitioner had no written record that it obtained consent to install R57’s bed rails.  Thus, even if R57’s daughter did consent to the use of bed rails, I find that such consent was not obtained prior to installation.  Further, because the signature near the blank for “Resident/POA Signature” is illegible, I am unable to determine from the form whether R57’s daughter signed it or whether it was signed by the nurse who completed the form.  If R57’s daughter did not sign the form, it is possible she did not read (or was not told) the list of risks printed on the form.  I am therefore unable to find it is more likely than not the consent given by R57’s daughter was “informed” as required by the regulation.

I find that the failure to assess R57 for entrapment risks and to obtain informed consent prior to installing bed rails placed R57 at risk for more than minimal harm.  Accordingly, I conclude that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(n).

***2.   Petitioner did not comply substantially with the Medicare participation requirement at 42 C.F.R. § 483.25(b)(1)(i)-(ii).***18

***a.   I find the following facts by a preponderance of the evidence.***

**Resident 57’s pressure ulcers.**  Beginning at least as early as January 5, 2018, R57’s care plan noted that he was at risk for pressure ulcers.  CMS Ex. 16 at 24; CMS Ex. 50 at 7.  In April of 2018, R57 had Stage II pressure ulcers to his left and right buttocks and left heel.  CMS Ex. 16 at 24.  As of September 14, 2018, the left heel pressure ulcer had worsened from Stage II to unstageable.  *Id.* Beginning July 12, 2018, R57’s care plan called for Petitioner’s nurses “to monitor and document . . . daily on bilateral buttock wounds, and left heel.”  *Id.*at 28.  The intervention to monitor and document R57’s pressure ulcers had revision dates of September 18 and 27, 2018.  *Id.* I infer from the revision dates that the intervention continued in effect as of those dates.  As of October 5,

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2018, R57 had a reoccurrence of the right gluteal pressure ulcer.  *Id.*at 24.  Also as of October 5, 2018, R57’s care team had ordered daily monitoring and documentation of R57’s pressure ulcers on his bilateral buttocks, right gluteal crease, and left heel.  CMS Ex. 51 at 3.

During the recertification survey on October 19, 2018, a surveyor interviewed Petitioner’s wound care nurse, LPN A.R. (LPN C).  CMS Ex. 1 at 37-38.  At that time, LPN A.R. “agreed that weekly documentation on the wound log was not completed fully” for R57.  *Id.*at 38.  Petitioner’s failure to document R57’s pressure ulcers in accordance with his care plan formed part of the factual basis for the deficiency citing noncompliance with 42 C.F.R. § 483.25(b)(1)(i)-(ii) (Treatment/Services to Prevent/Heal Pressure Ulcer).  *See*CMS Ex. 1 at 34-38.

Following the recertification survey, on November 12, 2018, Petitioner’s staff added a new intervention to R57’s care plan, requiring application of a “nickel thick” layer of cream to both gluteal folds every hour.19  CMS Ex. 50 at 7; *see also*CMS Ex. 53 at 1.  In addition, staff added a requirement to monitor and document R57’s bilateral gluteal crease area for existing and new pressure wounds.  *Id.* at 8.  The previous interventions to monitor and document R57’s pressure ulcers daily and to document the location and size of his pressure ulcers weekly remained in effect.  *Id.* at 7; *see also*CMS Ex. 16 at 28.

**State agency revisit survey.**  Between December 19 and 21, 2018, the state agency conducted a revisit survey at Petitioner’s facility.  CMS Ex. 2 at 1.  Surveyor Keller was the team leader for the revisit survey.  Tr. at 56.  In addition, she made the observations, conducted the interviews, and performed the record review that formed the basis for the continued deficiency related to R57’s pressure ulcers.  *Id.* I find by a preponderance of the evidence that the statements and observations in the statement of deficiencies for the revisit survey accurately record what Surveyor Keller observed and heard during the survey, as it relates to R57’s pressure ulcers.

On December 21, 2018, Surveyor Keller observed two of Petitioner’s CNAs performing pericare and applying barrier cream for R57.20  CMS Ex. 2 at 2; *see also*Tr. at 56.

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Surveyor Keller noted a pressure injury on R57’s right medial buttock near the crease.  CMS Ex. 2 at 2.  No member of Petitioner’s staff measured or assessed R57’s pressure ulcers at that time.  *Id*.  Surveyor Keller observed the CNAs place a small plastic medication cup containing a small amount of barrier cream on an overbed table by R57’s bed.  *Id.* Surveyor Keller estimated that the medication cup would hold about one ounce and observed that the cup was approximately 1/3 full.  *Id.* CNA C.D. applied a thin layer of barrier cream to R57’s scrotal, perineal, buttocks, and sacral skin.  *Id*.  R57’s skin was visible through the layer of cream.  *Id*.  Unused barrier cream remained in the cup.  *Id*.

Surveyor Keller reviewed R57’s medical records, which documented a new pressure ulcer on November 25, 2018.  *Id.*at 3.  The ulcer was located at the coccyx, measuring .5 cm by .7 cm with open edges, no surrounding maceration, and no drainage.  *Id*.

Surveyor Keller reviewed R57’s Wound Log from November 23, 2018 through December 21, 2018.  *Id.* at 4.  The Wound Log identified eight potential pressure injuries.  *Id*.  The Wound Log only included documentation for the week of December 6, 2018.  *Id*.  The Wound Log did not document the location, stage, date acquired, improvement, or worsening of the wounds.  *Id*.  Surveyor Keller reviewed the Wound Log with Petitioner’s DON on December 19, 2019.  *Id.* The DON acknowledged the Wound Log was incomplete and had not been completed weekly.  *Id*.  The DON further confirmed that the Wound Log is where facility staff are expected to document the treatment and progression of resident wounds.  *Id*.  The DON was quoted as saying, “It looks like we need to develop another plan for how we document wounds.”  *Id*. at 4-5.

On December 21, 2018, Surveyor Keller again spoke with Petitioner’s DON and asked for all documentation regarding R57’s pressure ulcers.  *Id.* at 6.  The surveyor specifically requested daily documentation of nursing notes pertaining to R57’s pressure ulcers, as ordered by R57’s physician.  In response, the DON stated that seven days of documentation were missing between November 23, 2018 and December 21, 2018.  *Id*.  When Surveyor Keller asked the DON if she had any concern with a continued deficiency related to pressure wound care, the DON replied, “No, I don’t.”  *Id*.  I interpret this statement as an acknowledgment that the facility continued to be out of substantial compliance with the participation requirement for pressure ulcers.

**Testimonial evidence.**  Petitioner presented the written direct testimony of CNA M.L., who described what she observed on December 21, 2018, when CNA C.D. attempted to treat R57.21  P. Ex. 31.  CNA M.L. testified that, during treatment, R57 “became very irritated and pulled the [CNA’s] hair, pinched her breast, and grabbed her stomach.”  *Id.*at 2 (¶ 7).  CNA M.L. stated that “the surveyor insisted that the [CNA] continue . . . to attempt to apply the cream to [R57’s] skin.”  *Id.*(¶ 9).  CNA M.L. admitted that the other

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CNA did not apply a nickel thick layer of cream, but that the thinner layer of cream was all “the care that was possible [given R57’s] agitated state.”  *Id.*

At the hearing, Surveyor Keller testified that, during the encounter, R57 did grab the CNA’s hair and shirt.  Tr. at 57.  However, she denied insisting that the CNAs continue providing care.  *Id.* Surveyor Keller stated that she neither told the CNAs to proceed nor to stop providing care:  “The survey process would not direct me to instruct staff to do anything there.  I’m an observer.  They are the providers and they direct the care.”  *Id.* Further, Surveyor Keller testified that R57’s behavior did not impede the CNA from applying the barrier cream.  *Id.*at 67.  Surveyor Keller stated, “[S]he took her time spreading [the cream] out . . . through a very large region. . . . [S]he didn’t have to rush, she just did not apply it as directed.  But no, it did not prevent her at all from doing the application of the cream.”  *Id.*

Based on this testimony, I find that R57 was combative when CNA C.D. was providing care.  However, I find credible Surveyor Keller’s testimony that it would be inconsistent with her training as a surveyor to instruct facility staff whether to proceed with care.  I therefore find by a preponderance of the evidence that Surveyor Keller did not “insist” that Petitioner’s CNAs continue to provide care to R57 in spite of his combativeness.  In addition, I find it more likely than not that the CNA could have applied the barrier cream nickel thick as directed.  I reach this conclusion based on Surveyor Keller’s observation that R57’s behavior did not impede the CNA at all.  In addition, M.L.’s testimony did not contradict that of Surveyor Keller.  CNA M.L. did not specify how long R57’s combative behavior lasted and did not state unequivocally that his behavior prevented C.D. from applying the cream as directed.

Petitioner also offered the written direct testimony of Nurse Practitioner B.B., who provided care to Petitioner’s residents as an independent contractor.  P. Ex. 36 at 1 (¶ 5).  B.B. stated that, at the time of the recertification survey (October 19, 2018), she did not agree with Surveyor Keller’s characterization of R57’s skin condition as a pressure ulcer.  *Id.*at 2-3 (¶ 11).  B.B. diagnosed R57’s condition as incontinent dermatitis, rather than as a pressure ulcer.  *Id.*  She further stated that, following the recertification survey, she documented R57’s wounds as pressure ulcers only because she felt she “had no choice” due to the “bullying” of Surveyor Keller.  *Id.*at 3 (¶ 12).  Nurse Practitioner B.B. also testified that the state agency “misstated/misrepresented” her order “purporting to require that skin ulcers on [R57’s] buttocks, right gluteal crease[,] and left heel be monitored and documented daily.”  *Id.*(¶ 14).  She stated that her “order was meant to require weekly documentation of [R57’s] wound care.”  *Id.*

Nurse Practitioner B.B.’s testimony is inconsistent with Petitioner’s records concerning R57’s care.  B.B.’s testimony implies that, prior to October 19, 2018, R57 was not diagnosed with pressure ulcers.  However, R57’s care plan documents that R57 had two sacral pressure ulcers on admission and was treated for several pressure ulcers, including on

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his left buttock and right heel, acquired on January 3, 2018.  CMS Ex. 16 at 27.  Petitioner’s care plan continued to address these pressure ulcers from January through October of 2018.  *Id.*at 24-28.  Further, the orders B.B. accuses the state agency of “misrepresenting” are clear on their face.  The order of October 5, 2018 states:  “Nurse to monitor bilateral buttock, [r]ight gluteal crease, left heel DTI’s [deep tissue injuries] and document on each *daily* in skin/wound note.  [E]very day shift for Multiple Pressure ulcers.”  CMS Ex. 51 at 3 (emphasis added).  That order plainly states that R57 was being treated for pressure ulcers and that nurses were to monitor his wounds daily.  Nothing in the statement of deficiencies misrepresents the content of that order.  Moreover, the order was dated prior to the recertification survey.

I infer that, in the course of her treatment of R57, Nurse Practitioner B.B. would have ample opportunity to review the orders as transcribed in R57’s medical records and to correct them, as needed.  However, Nurse Practitioner B.B. did not attempt to correct the October 5, 2018 order in R57’s medical record until December 26, 2018, which was after the revisit survey.  P. Ex. 36 at 3 (¶ 14).  From the timing of that correction, I infer that Nurse Practitioner B.B. had an interest in minimizing Petitioner’s responsibility, and her own, for the deficiencies in the care provided R57 revealed by the revisit survey.  In addition, B.B.’s written direct testimony was prepared in support of Petitioner’s litigation posture, well after the events in question.  For all these reasons, I accord little weight to Nurse Practitioner B.B.’s written direct testimony.

***b.   Petitioner failed to treat and document R57’s pressure ulcers in accordance with physician orders and R57’s care plan.***

42 C.F.R. § 483.25(b)(1)(ii) states:  “Pressure ulcers.  Based on the comprehensive assessment of a resident, the facility must ensure that . . . (ii) [a] resident with pressure ulcers receives necessary treatment and services, consistent with professional standards of practice, to promote healing, prevent infection and prevent new ulcers from developing.”

In the present case, CMS has provided evidence that Petitioner failed to follow R57’s care plan when its staff failed to apply a nickel thick layer of barrier cream on R57’s buttocks on December 21, 2018, and failed to properly document his pressure ulcers.  Accordingly, I find that CMS has established a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(b)(1)(ii).

Petitioner acknowledges that R57 was not provided a nickel thick layer of barrier cream on December 21, 2018.  However, Petitioner argues that this was unavoidable due to R57’s agitated state and, therefore, was still within the applicable standards of care.  P. Post-hrg. Br. at 6-7; P. Reply at 6-7.  I reject this argument as inconsistent with the facts I have found above.  As previously noted, even though R57 was combative with

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care at the time the surveyor observed it, R57’s combativeness would not have prevented the CNA from applying the cream as directed.

But, even if I were to find that Petitioner’s failure to provide R57 with a nickel thick layer of barrier cream on December 21, 2018, was unavoidable, I would nevertheless find that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(b)(1)(ii).  This is because Petitioner does not dispute that its staff failed to evaluate and document R57’s pressure ulcers daily as provided in his orders and care plan.  P. Br. at 20, 21 (arguing that the applicable standard of care does not require daily documentation); *see also*P. Ex. 36 at 2 (¶ 8).  The appellate decision in *Gooding Rehab. & Living Ctr.*, DAB No. 2239 at 13 (2009), holds that a facility’s failure to follow its own orders, including orders for daily monitoring and documentation of pressure ulcers, supports a finding of substantial noncompliance with 42 C.F.R. § 483.25(b)(1)(ii).22

Contrary to R57’s medical orders and care plan that required daily documentation, Petitioner argues that it was not Petitioner’s intention to have R57’s wounds documented daily.  P. Br. at 21.  Petitioner relies on the testimony of Nurse Practitioner B.B., who states that she intended for Petitioner’s staff to document R57’s wounds weekly.  P. Ex. 36 at 3 (¶ 14).  I reject Petitioner’s argument that daily wound documentation was not required.  As I have stated above, I find Nurse Practitioner B.B.’s declaration unpersuasive in the face of two separate orders that clearly call for daily wound checks and documentation, a practice Petitioner admits it did not follow.  CMS Ex. 50 at 8; CMS Ex. 51 at 4.  Moreover, even if Petitioner were only required to document R57’s wounds weekly, Petitioner failed to comply even with this lower standard.  During the revisit survey, Surveyor Keller found that R57’s Wound Log for dates from November 23, 2018 through December 21, 2018, only included documentation for the week of December 6, 2018.  CMS Ex. 2 at 4.  Petitioner’s DON acknowledged the Wound Log was incomplete and had not been completed weekly.  *Id*.

Accordingly, I find that Petitioner’s treatment and documentation of R57’s pressure ulcers failed to comply substantially with 42 C.F.R. § 483.25(b)(1)(ii).

Page 25

***3.   Petitioner failed to prove that CMS’s immediate jeopardy determination was clearly erroneous***

CMS determined that Petitioner’s noncompliance with 42 C.F.R. §§ 483.25(d)(1)-(2) and 483.25(n) posed immediate jeopardy to the health and safety of Petitioner’s residents.  *See, e.g.,*CMS Ex. 6 at 1.  Immediate jeopardy exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  The regulation does not require that a resident *actually*be harmed.  *Lakeport Skilled Nursing Ctr.,*DAB No. 2435 at 8 (2012).  I may not overturn a finding of immediate jeopardy unless I conclude the finding was clearly erroneous.  42 C.F.R. § 498.60(c)(2). Appellate decisions of the DAB have interpreted section 498.60(c)(2) as creating a presumption that CMS’s finding of immediate jeopardy is correct:

[The clearly erroneous] standard of review requires the [administrative law judge] and the Board in effect to presume that CMS’s determination of immediate jeopardy is correct unless the [facility] demonstrates that the determination is clearly erroneous.

*Daughters of Miriam Ctr.*, DAB No. 2067 at 7 (2007).  Thus, the clearly erroneous standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  *Id.; see also Barbourville Nursing Home*, DAB No. 1962 at 11 (2005), *aff’d*, *Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006).  Put another way, I may set aside the finding of immediate jeopardy only if, after reviewing all the evidence, I am “left with the definite and firm conviction that a mistake has been committed.”  *Easley v. Cromartie*, 532 U.S. 234, 242 (2001).  Having reviewed the evidence, I am not left with the definite and firm conviction that the finding of immediate jeopardy was mistaken.  To the contrary, I conclude that the finding of immediate jeopardy must be sustained because it was not clearly erroneous.

Petitioner argues that CMS’s determination of immediate jeopardy is clearly erroneous because R57 did not suffer serious harm when his mattress deflated on two occasions.  P. Post-hrg. Br. at 5.  Petitioner further argues that it is mere “conjecture” to conclude that R57 could have sustained serious injury or death.  *Id.* I disagree.

First, as I have already stated, a finding of immediate jeopardy does not require as a prerequisite that a resident have experienced actual harm.  *Lakeport Skilled Nursing Ctr.,*DAB No. 2435 at 8.  That R57 experienced only minor injuries when he became entrapped in his bed rail and, later, between his bed and the wall, is merely fortuitous.  It is plain that, had R57 not been discovered and assisted, he would likely have experienced much more serious injury.  Petitioner’s own Siderail Risk and Consent form demonstrates that the risks of becoming entrapped by bed rails include asphyxiation and death.  CMS

Page 26

Ex. 21 at 1.  The FDA has confirmed that vulnerable patients,23 including residents of long-term care facilities, are at risk of death and injury if they become entrapped in hospital beds and bed rails.  CMS Ex. 59 at 6.  Similarly, appellate decisions of the DAB have concluded that the risk of bed rail entrapment poses immediate jeopardy to resident health and safety.  *Good Samaritan*, DAB No. 1844 at *13 (affirming the administrative law judge’s determination that entrapment hazards present a likely risk of serious injury, harm, impairment, or death to a resident).  Moreover, Petitioner completely fails to address the fact that its failure to inspect all resident beds for gaps that could put residents at risk for entrapment endangered not just R57, but all of its mobility- and cognitively-impaired residents.

Accordingly, for the reasons just discussed, I find that CMS did not clearly err in concluding that Petitioner’s noncompliance with 42 C.F.R. §§ 483.25(d)(1)-(2) and 483.25(n) posed immediate jeopardy to the health and safety of Petitioner’s residents.

***4.   The CMPs imposed, $19,208 per day for 3 days and $1,210 per day for 91 days, are reasonable in amount and duration***.

I have concluded that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(d) and (n) and that CMS did not clearly err in determining that Petitioner’s noncompliance posed immediate jeopardy.  I further upheld CMS’s determination that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(b)(1)(ii) at less than immediate jeopardy beginning October 19, 2018.  I next explain why I conclude that the CMPs imposed for Petitioner’s noncompliance are reasonable in amount and duration.

**Amount.**To determine whether the amount of a CMP is reasonable, I examine the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  The factors listed in § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS imposed, the administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

Page 27

The regulations specify that a per-day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  CMS imposes a CMP in the upper range, $6,524 to $21,393 per day, 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).24  CMS imposes a CMP in the lower range, $107 to $6,418 per day, 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).  In assessing the reasonableness of a CMP amount, an administrative law judge considers the per day amount, rather than the total accrued CMP.  *See Kenton Healthcare, LLC*, DAB No. 2186 at 28 (2008).  The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); *see also*42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare,*DAB No. 2186 at 28-29.

CMS decided to impose per-day CMPs in this case, and I have found that the declaration of immediate jeopardy was not clearly erroneous.  For the period of Petitioner’s immediate jeopardy level noncompliance (October 16 – 18, 2018), CMS imposed a CMP of $19,208 per day, which is near the maximum for immediate jeopardy level noncompliance.  For the period of Petitioner’s non-immediate jeopardy level noncompliance (October 19, 2018 through January 17, 2019), CMS imposed a per day CMP of $1,210 per day, which is approximately 20 percent of the maximum for non-immediate jeopardy level noncompliance.

Petitioner argues, without citation to the record, that “Schoolcraft has a history of favorable rankings and evaluations” and “Schoolcraft’s financial situation will be harmed” if I sustain the CMPs at issue.  P. Br. at 24.  Because Petitioner has provided no evidentiary support for its conclusory assertions, I do not consider these factors.  However, I conclude that the factors of seriousness and culpability support the reasonableness of the immediate jeopardy level CMP.

As I have described above, Petitioner did not evaluate residents for entrapment risks, did not obtain informed consent prior to installing bed rails on R57’s bed, and did not properly investigate the cause of R57’s August 5, 2018 entrapment, which led to a second entrapment less than thirty days later.  Petitioner’s noncompliance placed R57 and other similarly situated residents at risk of entrapment, which could lead to serious injury,

Page 28

asphyxiation, and death.  Thus, Petitioner’s noncompliance was serious and Petitioner was culpable – in the sense of responsible – for the noncompliance.  Based on the factors of seriousness and culpability, I find that a CMP near the maximum for immediate jeopardy level noncompliance is reasonable.

I also find that the CMP imposed at the non-immediate jeopardy level for Petitioner’s failure to properly treat and document R57’s pressure ulcers is reasonable.  Petitioner failed to comply with 42 C.F.R. § 483.25(b)(1)(ii) in two separate ways:  failure to treat and failure to document.  Petitioner’s noncompliance put R57 at risk of harm in that his existing pressure ulcers could have worsened and he could have developed additional pressure ulcers.  Moreover, R57 continued to be exposed to these risks over a long period of time.  Petitioner was found out of substantial compliance with 42 C.F.R. § 483.25(b)(1)(ii) beginning with the recertification survey and continuing for 91 days, until January 17, 2019.  Given Petitioner’s lengthy period of noncompliance, I conclude that a CMP of $1,210 per day is reasonably calculated to serve the underlying purpose of a CMP, which is to give facilities “an incentive to return to substantial compliance as soon as possible and to remain in substantial compliance.”  *Jewish Home of E. Pa.*, DAB No. 2451 at 10 (2012) (citing *Careplex of Silver Spring*, DAB No. 1683 at 9 (1999)); *see also*42 C.F.R. § 488.402(a).

While I am mindful that the cumulative total of the CMPs imposed is large, I am limited to considering whether the per-day amount of the CMPs is reasonable.  *Kenton Healthcare,*DAB No. 2186 at 28.  For the reasons I have explained, I find that the per-day CMP amounts imposed are reasonable.

**Duration:**  The parties’ arguments about the reasonableness of the CMPs focus on the amount of the CMPs; they make no specific arguments about the reasonableness of the proposed duration of the CMPs.  Petitioner argues that it was at all times in substantial compliance and, for that reason, no CMPs should be imposed.  P. Br. at 20.  For all the reasons discussed above, I have concluded that Petitioner was out of substantial compliance and that the finding of immediate jeopardy is not clearly erroneous.

It is well-settled that, once CMS has demonstrated a facility is not in substantial compliance with Medicare participation requirements, continuing noncompliance is presumed and the burden is on the facility to demonstrate it returned to substantial compliance earlier than the date alleged by CMS.  *Premier Living & Rehab. Ctr.*, DAB No. 2146 at 23 (2008) (“[O]nce a facility has been found to be out of substantial compliance, it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again.”).  CMS found that Petitioner returned to substantial compliance with Medicare participation requirements effective January 18, 2019.  CMS Ex. 12 at 1.  Petitioner presented no evidence that, should I find it noncompliant, it returned to substantial compliance prior to January 18, 2019.  Accordingly, I conclude that the duration of the proposed CMPs is reasonable.

Page 29

V.   Conclusion

For the reasons discussed above, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirements at issue.  Moreover, Petitioner did not establish that CMS’s immediate jeopardy determination was clearly erroneous.  Accordingly, I conclude that CMS had a basis to impose a CMP.  Finally, I conclude that the CMPs imposed are reasonable.

Endnotes

1 The state agency additionally conducted a life safety code survey of Petitioner’s facility on October 17, 2018.  CMS Ex. 5 at 1.  That survey found that Petitioner was not in compliance with life safety code requirements.  *Id.* However, the alleged life safety code deficiencies are not before me in this proceeding.

2  Petitioner did not appeal 12 deficiencies that CMS cited at the non-immediate jeopardy level of scope and severity.  *Compare*Petitioner’s hearing request, Docket Entry # 1, *with*CMS Ex. 1.

3 CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies.  *See* 42 C.F.R. § 488.408.  CMS summarizes the scope and severity levels in a matrix published in the State Operations Manual (SOM).  At the time of the survey at issue, the matrix was published at section 7400.5.1. of the SOM.  CMS Pub. 100-07, ch. 7, § 7400.5.1 (Rev. 63, eff. Sept. 10, 2010) available at https://www.cms.gov/Regulations-and-Guidance/Guidance/transmittals/downloads/R63SOMA.pdf (last visited Aug. 5, 2022).  In the current version of the SOM, the matrix appears at section 7400.3.1.  *Id.*(Rev. 185, eff. Nov. 16, 2018), available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107c07pdf.pdf (last visited Aug. 5, 2022).  As relevant here, scope and severity level “J” corresponds to an isolated deficiency that poses immediate jeopardy to resident health or safety; level “G” corresponds to a pattern of deficiencies that does not cause actual harm but has the potential for causing more than minimal harm; and level “D” corresponds to an isolated deficiency that does not cause actual harm but has the potential for causing more than minimal harm.

4 CMS withdrew its reliance on the deficiency citation for 42 C.F.R. § 483.90(d)(3), acknowledging that the regulation was not yet published in the Federal Register.  CMS Post-hearing Brief at 2 n.1 (citing 84 Fed. Reg. 34,737, 34,738 (July 18, 2019) (proposing rule) and 85 Fed. Reg. 52,703, 52,713 (Aug. 26, 2020) (scheduling final action for July 2022)).

5 However, as previously noted, CMS no longer relies on the deficiency based on Petitioner’s alleged noncompliance with § 483.90(d)(3).  *See*n.4, *supra*.

6 I refer to the page numbers printed at the upper right corner of the transcript pages and not to the PDF page numbers.

7 To protect his privacy, I refer to the resident by the numerical identifier assigned during the state agency survey.  *See*CMS Ex. 13.

8 BIMS scores are categorized into 3 levels:  cognitively intact (13-15), moderately impaired (8-12), and severe impairment (0-7).  *See* Long-Term Care Facility Resident Assessment Instrument 3.0 User’s Manual, Ch. 3 (Overview to the Item-by-Item Guide to the MDS 3.0), § C0500 (Summary Score)), https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Downloads/MDS-30-RAI-Manual-V113.pdf (last visited August 12, 2022) (the cited material appears at page 168 of the PDF file).

9  I refer to Petitioner’s staff members by their initials.  CMS offered an “Interviewee/Witness Identifier Form as CMS Ex. 14.  This form assigned alphabetical identifiers to some members of Petitioner’s staff.  However, because not all relevant staff members were assigned identifiers, I find it more efficient to identify all staff by their initials.

10 The record does not reveal whether N.W. was a registered nurse (RN) or a licensed practical nurse (LPN).

11 At the time of the recertification survey, R57’s bed was equipped with an Invacare mattress.  *See*Tr. at 28.  However, as Surveyor Keller acknowledged at the hearing, the mattress that was on the bed during the August 5 and September 2, 2018 incidents was a Patriot mattress.  *Id.*at 28-29.

12 A comparison of the signatures leads me to infer that the nurse who completed the bed rail consent form for R57 was Petitioner’s wound care nurse, LPN A.R.  *Compare*P. Ex. 21 at 1 *with* P. Ex. 35 at 4.

13 Nurse T.S. (RN U) is the same individual who completed the incident report for the September 2 incident involving R57.  *Compare*CMS Ex. 20 at 1 *with*CMS Ex. 14 at 1.

14 At the time of the interview, CNA F.H. was no longer employed at Petitioner’s facility.  CMS Ex. 22 at 3.  He told Surveyor Keller he had resigned.  *Id.*

15 I also accord no weight to P. Exs. 14 and 15, which appear similar to the photographs in Exhibits A and B to J.W.’s written direct testimony (except that P. Exs. 14 and 15 are in color).  J.W. was unable to identify P. Exs. 14 and 15 and, as was the case with Exhibits A and B, he was unable to say who took the photographs or when.

16 I cite to the decisions in these cases as they are paginated in Westlaw.  The *Good Samaritan*decision is available at 2002 WL 31106428; *Me. Veterans’ Home – Scarborough*is available at 2005 WL 1164060.

17  At the time the DAB issued the decisions in *Good Samaritan*and *Me. Veterans’ Home - Scarborough*, the participation requirement for Accident Hazards/Supervision/Devices was codified at 42 C.F.R. § 483.25(h).  Effective November 28, 2016, the requirement was redesignated as 42 C.F.R. § 483.25(d).  81 Fed. Reg. 68,688, 68,828, 68,860 (Oct. 4, 2016).  The content of 42 C.F.R. § 483.25(h) was not altered when it was redesignated as 42 C.F.R. § 483.25(d).

18 The participation requirement includes both subsections (i) and (ii) of 42 C.F.R. § 483.25(b)(1).  The statement of deficiencies alleges that Petitioner failed to provide appropriate care and treatment for R57’s pressure ulcers, which falls within the requirement defined at 42 C.F.R. § 483.25(b)(1)(ii).

19 Surveyor Keller testified that Petitioner’s staff explained that a nickel thick layer of cream was required because R57 had frequent loose stools due to a gluten intolerance.  Tr. at 67.  Therefore, staff needed to apply the cream “so that it was impermeable to any loose stool that could erode the skin.”  *Id.*

20 The statement of deficiencies identifies the staff members as “CNA W” and “CNA XX.”  CMS Ex. 2 at 2.  According to the Interviewee/Witness Identifier Form, CNA W’s initials are M.L., and CNA XX’s initials are C.D.  CMS Ex. 14 at 1-2.  Petitioner offered the written direct testimony of CNA M.L. as P. Ex. 31.  Petitioner did not offer a statement from CNA C.D.  I discuss CNA M.L.’s testimony in more detail below.

21 CNA M.L. does not identify the other CNA in her written direct testimony.  I infer that the other CNA was C.D. based on the statement of deficiencies.  *See*CMS Ex. 2 at 2.

22 The *Gooding Rehab.*decision was issued in 2006.  At that time, the Medicare participation requirement for pressure sores was codified at 42 C.F.R. § 483.25(c).  Effective November 28, 2016, the requirement was recodified as 42 C.F.R. § 483.25(b)(1).  81 Fed. Reg. at 68,688, 68,828, 68,860.  The recodified provision is substantially similar, except that the drafters added that care must be provided “consistent with professional standards of practice.”  *Id.*at 68,860.

23 The FDA guidance defines “vulnerable patients” as:  “Patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement or who get out of bed and walk unsafely without assistance.  These patients most often have been frail, elderly or confused.”  CMS Ex. 59 at 6 n.7.  This description would include R57 and likely other residents of Petitioner’s facility.

24 The CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102.  The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case.  *See*83 Fed. Reg. 51,369, 51,380 (Oct. 11, 2018).
  
          /s/
        Leslie A. Weyn

                      Administrative Law Judge Back to top
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