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                              Hillcrest Health and Rehabilitation, DAB CR6231 (2023)
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Hillcrest Health and Rehabilitation, DAB CR6231 (2023)








  
  
    

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





Hillcrest Health and Rehabilitation
(CCN: 285133),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-887Decision No. CR6231February 13, 2023

        
              
    

      DECISION

Petitioner, Hillcrest Health and Rehabilitation, was not in substantial compliance with program participation requirements from March 12 through April 10, 2019.  Petitioner was not in substantial compliance due to a violation of 42 C.F.R. § 483.25(d)(2),1 which posed a risk of more than minimal harm to one of its residents.  There is a basis for the imposition of a civil money penalty (CMP) of $1,550 per day from March 12 through April 10, 2019, a total CMP of $46,500.

I.     Background

Petitioner, located in Bellevue, Nebraska, participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint

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Stipulation of Facts (Jt. Stip.) ¶ 1; Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1; Petitioner’s Exhibit (P. Ex.) 10.  On March 13, 2019, the Nebraska Department of Health and Human Services (state agency) completed a complaint investigation of Petitioner and found Petitioner was not in substantial compliance with program participation requirements.  Jt. Stip.¶ 2-5; CMS Exs. 1-3; P. Exs. 10-12.

CMS notified Petitioner of its initial determination to impose an enforcement remedy by letter dated April 22, 2019.  CMS advised Petitioner that it concurred with the state agency findings of noncompliance.  CMS further advised Petitioner that a denial of payments for new admissions (DPNA) would be effective April 12, 2019, and mandatory termination of Petitioner’s provider agreement would occur effective July 29, 2019, if Petitioner did not return to substantial compliance before those dates.  CMS also imposed a CMP of $1,550 per day beginning March 12, 2019, and continuing until further notice from CMS, based on the noncompliance cited by the surveyor under Tag F689,2 which alleged a violation of 42 C.F.R. § 483.25(d).  CMS Ex. 2 at 1-3; P. Ex. 11 at 1-3.

CMS notified Petitioner by letter dated June 13, 2019, that Petitioner achieved substantial compliance with Medicare participation requirements effective April 11, 2019.  CMS advised Petitioner that the proposed termination and DPNA were rescinded and that the CMP of $1,550 per day accrued from March 12 through April 10, 2019, a total CMP of $46,500.  CMS Ex. 3; P. Ex. 12.

Petitioner requested a hearing before an administrative law judge (ALJ) on June 19, 2019 (RFH).  The case was assigned to me for hearing and decision on June 24, 2019, and an Acknowledgment and Prehearing Order was issued at my direction.

On February 2, 2021, a hearing was convened by video teleconference, and a transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 7, 9, and 35,

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which were all admitted as evidence.  Tr. 19.  Petitioner offered P. Exs. 10 through 34, which were all admitted as evidence.  Tr. 19-20.  CMS called Lori Frodsham, a state agency surveyor, to testify.  Petitioner called the following witnesses:  Dena Behrns, Registered Nurse (RN) (Tr. 39-40; P. Ex. 25); Anthony Hatcher, Doctor of Osteopathic Medicine (DO), Fellow of the American Academy of Family Physicians (FAAFP), Petitioner’s chief medical officer (Tr. 58-77; P. Ex. 26); Tammy Weston, Petitioner’s Administrator (Tr. 78-119); and Dottie Rice, RN, Petitioner’s regional director of clinical services (Tr. 119-33).

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**

**1.  Statutory and Regulatory Medicare Program Enforcement**

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS) to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including

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a discretionary DPNA, civil money penalties (CMP), appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b).  “*Substantial compliance*means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  42 C.F.R. § 488.301.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

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

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  CMS is authorized to impose a CMP on a per day or per instance basis.  In this case, CMS proposed a per day CMP.  On April 22, 2019, the date of the CMS initial determination, CMS was authorized to impose a per day CMP in the lower range of CMPs of $107 to $6,418 per day, for noncompliance that did not pose immediate jeopardy.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2018).

The Act and regulations make a hearing before an ALJ available to a SNF against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.”  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.”  42 C.F.R. § 498.60(c)(2);

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*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).

**2.  Burden of Proof, Burden of Production, and Quantum of Evidence**

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 proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.4  Rather, the Board has long held that the petitioner, i.e., the nongovernmental party affected by CMS action imposing an enforcement remedy, bears the ultimate 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.

Page 6

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 CMS has the initial burden of production to make a prima facie showing of noncompliance.  If CMS makes a prima facie showing, then the facility bears the burden 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 clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.”  *Id.*; *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  *Black’s Law Dictionary*1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true and to raise a presumption, subject to being disproved or rebutted.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether Petitioner has the burden of persuasion even if CMS failed to make a prima facie showing on each element of its case.  It is also unclear from prior Board decisions whether CMS can make a prima facie showing with mere allegations or a scintilla of evidence.  In this case, I conclude 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; and

Whether the CMP imposed is 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

Page 7

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

The surveyors cited Petitioner for violations of 42 C.F.R. §§ 483.12(c)(1) and (4) (Tag F609) and 483.25(d) (Tag F689).  Jt. Stip. ¶ 3; CMS Ex. 1 at 1, 4; P. Ex. 10 at 1, 4.  However, CMS imposed the CMP, the only enforcement remedy in this case, based only upon the alleged noncompliance under Tag F689.  CMS Ex. 2 at 1; P. Ex. 11 at 1; Tr. 6-8.  Petitioner’s right to review and my authority to conduct review are limited to the alleged noncompliance for which CMS decided to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.330(e)(3), 488.408(g), 498.3(b)(13).  Therefore, only the alleged noncompliance under Tag F689 is subject to review in this case.

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

CMS made a prima facie showing of noncompliance under Tag F689, by showing that Petitioner violated 42 C.F.R. § 483.25(d) , and that the violation posed a risk for more than minimal harm;
	Petitioner has not rebutted the CMS prima facie showing or established an affirmative defense to the alleged noncompliance by a preponderance of the evidence; and
	The proposed enforcement remedy is reasonable.**1.  Petitioner violated 42 C.F.R. § 483.25(d) as alleged under Tag F689.**

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

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**a. Facts**

Resident 1 is the only resident involved in the survey.  Resident 1, a female, was 72 years old on February 17, 2019, when the events that are the basis for the allegation of noncompliance occurred.  CMS Ex. 1 at 5; CMS Ex. 4 at 2, 38; P. Ex. 27 at 1.  Resident 1 was admitted to Petitioner on December 31, 2018.  Resident 1 had a history of repeated falls, a history of fractures of both legs, she had suffered a stroke with continuing speech difficulty, she suffered muscle weakness, difficulty walking, unsteadiness on her feet, lack of coordination, malaise, altered mental state, diabetes mellitus with hyperglycemia, and she had a knee replacement, among other diagnoses.  She needed assistance with personal care.  P. Ex. 27 at 1.

Dr. Anthony Hatcher testified that he is the chief medical officer for Petitioner’s parent organization, but he is not Petitioner’s medical director.  Tr. 59.  Based on his review of Resident 1’s medical record, he testified that Resident 1 was admitted to Petitioner on December 31, 2018, following a stroke on about December 4, 2018, that required hospitalization.  Resident 1 suffered residuals of the stroke including slurred speech and right-side weakness.  She was on antiplatelet therapy including aspirin and Plavix®.  P. Ex. 26 ¶ 7.  He testified that she was not ambulatory on her own, she needed assistance with sitting and standing, and she was normal cognitively.  P. Ex. 26 ¶ 8; Tr. 72-73.

Petitioner had a care plan to address Resident 1’s risk for falls.  Interventions included encouraging the resident to use her call light, physical and occupational therapy, actively engaging the resident and her family in fall prevention, ensuring her left knee brace was in place when she was out of bed; transferring her to her left; and keeping frequently used items within reach.  P. Ex. 28 at 3-4, 11-12, 17, 26-28; CMS Ex. 4 at 16-17.  Petitioner’s activities of daily living (ADL) care plan for Resident 1 shows that she was not ambulatory, except with a wheelchair or walker, and she required extensive assistance of staff for transfers.  P. Ex. 28 at 4-6, 19-20; CMS Ex. 4 at 17-19.

Petitioner placed in evidence occupational therapy (OT) progress notes and physical therapy (PT) progress notes and a PT report.  P. Exs. 20, 21.  OT notes dated February 1 through 12, 2019, all show that Resident 1 was at high risk for falls.  OT worked with Resident 1 on balance, strength, body mechanics, positioning maneuvers, safety awareness, safe wheelchair use, safe transfers, and other skills necessary to improve her ADLs.  P. Ex. 20.  A PT progress report identified Resident 1’s problems as difficulty walking, muscle weakness, unsteadiness on her feet, and malaise.  P. Ex. 21 at 7.  PT notes dated February 1 through 12, 2019, show that Resident 1 was assessed as being at high risk for falls.  PT worked with Resident 1 on strengthening her lower extremities, transferring, standing, walking, balance, and use of her left knee brace, among other things.  P. Ex. 21 at 1-6.  Petitioner also placed in evidence OT, PT, and speech therapy progress notes from the month of January 2019.  P. Ex. 16.

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Petitioner placed in evidence clinical notes for Resident 1 dated from January 1 through March 11, 2019.  P. Ex. 18.  The notes reflect that Resident 1 was admitted to Petitioner for rehabilitation following a stroke, she had weakness on her right side and difficulty speaking though she could make her needs known, and she required the assistance of two staff for transfers.  P. Ex. 18 at 1-4, 10.  The clinical notes show that on February 17, 2019, at about 9:10 am, Resident 1 was found on the floor beside her bed.  Resident 1 told staff that she tried to get up and walk to the bathroom and fell.  She told staff that she hit her head on the foot of the bed and fell on the floor.  She complained of head pain and left knee pain.  The note indicates that Resident 1 knew she was not supposed to try to walk.  After the fall, Resident 1 was placed in bed by three staff using a lift.  A nurse practitioner subsequently ordered that Resident 1 be sent to the hospital to check her for head trauma, altered mental status, and left knee pain.  The note also indicates that the resident was transferred to the hospital because she took blood thinner.  Resident 1 was readmitted to Petitioner on February 19, 2019, with orders to wear a soft collar on her neck at all times.6  P. Ex. 18 at 7; CMS Ex. 4 at 40.

Tammy Weston, Petitioner’s Administrator, testified that on February 18, 2019, she conducted the investigation of Resident 1’s February 17, 2019 fall.  The report of her investigation is in evidence as P. Ex. 14.  Her investigation was triggered by a call from Resident 1’s daughter.7  Tr. 82-83.  She testified that Resident 1 had no prior history of

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getting out of bed without assistance at Petitioner and Resident 1 was aware she should wait for staff assistance.  Tr. 93-94.

Petitioner placed in evidence the affidavits of two nurses (Licensed Practical Nurse (LPN) Shelly Morris and RN Dena Behrns) and two nurse aides (NA) (Yizrael Alvarez and Johnnitta Skipper) who assisted Resident 1 following the resident’s fall on February 17, 2019.8  RN Behrns testified that she checked on Resident 1 before about 8:00 a.m. on February 17, 2019, and the resident was sleeping.  She checked on the resident again just before 9:00 a.m., and Resident 1 was in bed and appeared to be asleep.  P. Ex. 25 ¶ 4.  Nurse Behrns admitted that she was not wearing a pager that would have alerted her that Resident 1’s call light was on, and she did not see whether Resident 1’s call light was activated while she was in Resident 1’s room.  P. Ex. 25 ¶ 5; Tr. 41-43.  Shortly after 9:00 a.m., NA Alvarez checked her pager and saw Resident 1’s call light was activated.  NA Alvarez entered Resident 1’s room and found the resident on the floor between her bed and the bathroom with her head near the foot of the bed.  NA Alvarez testified that Resident 1 was alert and talking after the fall.  P. Ex. 24 ¶¶ 5, 7.  NA Alvarez called out for assistance.  RN Behrns testified that she immediately responded and began assessing Resident 1.  Resident 1 told RN Behrns that she tried to get up and walk to the bathroom, when she fell and hit her head on the foot of the bed.  Resident 1 reported head and left knee pain.  RN Behrns opined that Resident 1 remained alert and did not lose consciousness.  P. Ex. 25 ¶¶ 6, 7.  RN Behrns testified that Resident 1 subsequently told her that she had not hit her head when she fell.  P. Ex. 25 ¶ 6; Tr. 47-49.  On cross-examination RN Behrns testified that she completed the event report related to Resident 1’s fall and she did not state in that report that Resident 1 denied hitting her head.  CMS Ex. 4 at 5; Tr. 43-45, 56.  RN Behrns also testified that the on-call nurse practitioner ordered that Resident 1 be sent to the emergency room to be checked for head trauma, altered mental status, and left knee pain, and because she was taking a blood thinner.  P. Ex. 25 ¶ 7.  According to LPN Morris, she was called to assist by RN Behrns.  In her opinion, Resident 1’s condition was at the resident’s baseline, i.e., there was no apparent injury.  P. Ex. 22.  NA Skipper testified that she helped get Resident 1 off the floor and, in her opinion, the resident was normal.  Although Resident 1 was not talking, she responded to direction from staff helping her.  P. Ex. 23 at 5.

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According to Petitioner’s call light “Activity & Response Time Analysis,” on February 17, 2019, Resident 1 initiated her call light at 8:16 a.m. and the call was not canceled until 9:08 a.m., 52 minutes and 40 seconds after it was initiated.  CMS Ex. 4 at 4, 21; P. Ex. 29.

Administrator Weston agreed that her investigation showed that Resident 1’s call light was on for 52 minutes.  Tr. 84, 101-02.  However, she also testified that based on her investigation, she concluded that Resident 1 was not unattended during that 52-minute period.  Tr. 86.  Because RN Behrns checked on Resident 1 just before 9:00 a.m. and she appeared to be sleeping and Resident 1 was found on the floor by NA Alvarez just a few minutes after 9:00 a.m., Administrator Weston opined that Resident 1 was not on the floor very long and that she had received adequate supervision.  Tr. 86-87, 92.  She opined that Resident 1 suffered no injury secondary to the fall on February 17, 2019.  Tr. 89-90.  She did agree that Resident 1 had complaints of pain after the fall, but Administrator Weston offered that Resident 1 often complained of pain.  Tr. 91.  Administrator Weston testified in response to my questions that Resident 1 was not supposed to be out of bed walking unassisted.  She agreed that a resident can suffer an injury if they fall.  Tr. 93.  Administrator Weston explained that when a resident pushed the call light button in the resident’s room, a light on the wall in the nurse’s office lighted, a light came on in the resident room, and a page was sent to the pagers of the NA and nurses on duty.  Tr. 106-10.  She admitted that RN Behrns did not have her pager the morning of February 17, 2019, and she should have.  Tr. 110.

Petitioner’s call light system policy required that Petitioner’s staff be equipped with pagers that notify them when a call light is activated.  The policy also required that staff timely respond to call lights, without defining “timely.”  The procedure specified that at the beginning of each shift each NA and nurse manager would sign-out a pager.  If a resident activated the call light, the NA assigned to the resident’s room would be notified by pager.  If the call light was not answered in five minutes, a reminder message was sent to all NAs and the nurse managers.  If the call light was not answered within 10 minutes all NAs, nurse managers, and the Assistant Director of Nursing were to be informed of the call light (by pager I infer).  CMS Ex. 6.

Petitioner’s call light policy failed to work as intended in the case of Resident 1 on February 17, 2019.  There is no dispute that at 8:16 a.m. on February 17, 2019, Resident 1’s call light was initiated.  The call light was not turned off until 9:08 a.m., roughly 52 minutes later.  P. Ex. 29.  RN Behrns did not have her pager and, it is more likely than not that is why she was unaware of the call light activation by Resident 1.  P. Ex. 25 ¶ 5; Tr. 41-43.  NA Alvarez did not notice that Resident 1’s call light was activated at 8:16 a.m. and did not discover that until a little after 9:00 a.m. on February 17, 2019, when she checked her pager.  P. Ex. 24 ¶¶ 5, 7.  According to Petitioner’s policy, NA Alvarez should have received the first page when the call light was activated at 8:16 a.m. on February 17, 2019.  Five minutes later, because the call light was unanswered, all NAs

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and nurse managers, not just RN Behrns and NA Alvarez, should have received the page.  Administrator Weston testified that there were three NAs and two nurses on duty in the area where Resident 1 lived the morning of February 17, 2019.  Tr. 85.  If the call light was not answered after 10 minutes all NAs, nurse managers, and the Assistant Director of Nursing should have been notified (I infer by pager though that is not specified in Petitioner’s policy).  CMS Ex. 6.

Dottie Rice, RN, Petitioner’s regional director of clinical services, opined that Resident 1 was adequately supervised because she had been checked on the morning of February 17, 2019, prior to the fall.  She speculated that someone had probably checked on Resident 1 shortly after the call light went off and simply forgot to turn off the call light.  Tr. 129-30, 132-33.  I do not accept her speculation as weighty evidence because it is unsupported by any evidence of record.  She also opined that Resident 1 suffered no injury due to the fall.  Tr. 133.  She did not, however, opine that Resident 1’s complaint of head pain and knee pain was false or that head and knee pain are not actual harm.

Dr. Hatcher testified in response to my questioning that falling poses a risk for everyone.  However, the risk is even higher for someone like Resident 1 who had a stroke and was obviously weak.  Tr. 76.  Dr. Hatcher opined that Resident 1 suffered no injury due to her fall on February 17, 2019.  Tr. 70; P. Ex. 26 ¶¶ 6, 12c.  He opined that intubation, while it may be shocking to a layperson, is a medical procedure like a blood draw or an x-ray and not trauma.  Tr. 70.  Dr. Hatcher stated that Resident 1 was sent to the hospital following her fall on February 17, 2019, because she complained of a headache and because she was on antiplatelet therapy.  P. Ex. 26 ¶¶ 9, 12a.  I infer based on his testimony that Resident 1 was at risk for more than minimal harm due to any fall.  Dr. Hatcher testified that hospital records (P. Ex. 32) show that examination at the hospital, including an MRI (magnetic resonance imaging), revealed no signs of trauma or other acute findings such as skin changes due to the fall.  P. Ex. 26 ¶¶ 11, 12.  Dr. Hatcher opined that the administration of Narcan® by emergency medical (EMS) services personnel is a reasonable explanation for why Resident 1 became unresponsive during her transport to the hospital on February 17, 2019, as there was no evidence of any traumatic injury due to the resident’s fall.9  P. Ex. 26 ¶ 12b.  Dr. Hatcher’s opinion that Narcan® may have

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caused Resident 1 to become unresponsive resulting in her intubation, is unrebutted and I consider the opinion both credible and weighty.  However, it is arguable that if not for the fall, there would have been no need to transport Resident 1 to the emergency department, EMS personnel would not have had the opportunity to administer Narcan®, Resident 1 would not have become unresponsive, and it would not have been necessary to intubate her, which there is no dispute, is an unpleasant procedure at best.  Dr. Hatcher did not opine that Resident 1’s complaint that she had head and knee pain after the fall was not true or not evidence of actual harm.  The resident’s complaint of head and knee pain has not been rebutted.  Therefore, I find that Resident 1 did suffer pain due to her fall.

**b.  Analysis**

I conclude based on my findings of fact that Petitioner violated 42 C.F.R. § 483.25(d) as alleged in the SOD under Tag F689, and that the violation posed a risk for more than minimal harm to Resident 1.

The regulation the surveyor alleged was violated requires:

Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, **the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan**, and the resident’s choices, including but not limited to the following:

* * * *

(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**.

42 C.F.R. § 483.25(d) (emphasis added).

A resident’s comprehensive care plan is prepared by the resident’s interdisciplinary team (IDT), which includes the resident’s attending physician, a registered nurse and nurse aide with responsibility for the resident, a member of the food and nutrition staff, the resident and/or resident’s representative, and other professionals and staff based on the resident’s needs.  42 C.F.R. § 483.21(b)(2)(ii).  The comprehensive care plan is based on

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the resident’s assessed medical, nursing, mental, and psychosocial needs.  42 C.F.R. § 483.21(b)(1).

Resident 1 had a falls care plan which shows that her IDT determined she was at risk for falls.10  The IDT determined as part of her falls care plan that one intervention to prevent falls was to encourage Resident 1 to use her call light.  P. Ex. 28 at 3-4, 11-12, 17, 26-28; CMS Ex. 4 at 16-17.  On February 17, 2019, at 8:16 a.m. Resident 1 used her call light, but no one responded within a few minutes.11  The evidence shows that on February 17, 2019, sometime between just a few minutes before 9:00 a.m. and a few minutes after 9:00 a.m., roughly 45 minutes after activating her call light, Resident 1 got out of bed unassisted to go to the bathroom and fell.  Resident told staff that she had head pain and left knee pain after the fall.  P. Ex. 18 at 7; P. Ex. 24 ¶ 5.  Both Dr. Hatcher and Administrator Weston agreed that there is a risk for harm if someone falls.  The fact that Petitioner’s protocol was to send a resident on antiplatelet therapy to the emergency room after a fall indicates that there was a risk for more than minimal harm to Resident 1.  P. Ex. 18 at 7; CMS Ex. 4 at 40; P. Ex. 26 ¶¶ 9, 12a; Tr. 91.  Surveyor Frodsham found that Resident 1 suffered actual harm, which is more than minimal harm.12  CMS Ex. 1

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at 4.  I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(d)(2) because the evidence shows that Petitioner failed to:

Meet the resident’s IDT assessed need for supervision and assistance when transferring or ambulating to prevent or minimize her risk for falling with or without injury;
	Follow the care planned intervention to prevent falls or minimize the risk for more than minimal harm to Resident 1 by ensuring that she was supervised for transfers and ambulation; and
	Ensure that staff was alerted to and responded to Resident 1’s call for assistance with transfers and ambulation through use of Petitioner’s call light system.I further conclude that CMS has made a prima facie showing that there was a risk for more than minimal harm to Resident 1 due to her fall.

Petitioner’s call light policy required that NAs, nurse managers, and the Assistant Director for Nursing have pagers that alerted them to respond to activated call lights in a timely manner.  P. Ex. 6.  Under Petitioner’s policy, if a resident activated the call light, the NA assigned to the resident’s room would be notified by pager.  If the call light was not answered in five minutes, a reminder message was sent to all NAs and the nurse managers.  If the call light was not answered within 10 minutes all NAs, nurse managers, and the Assistant Director of Nursing were to be informed of the call light (by pager I infer).  CMS Ex. 6.  Petitioner’s call light policy failed to work as intended in the case of Resident 1 on February 17, 2019.  P. Br. at 9.  There is no dispute that at 8:16 a.m. on February 17, 2019, Resident 1’s call light was initiated.  The call light was not turned off until 9:08 a.m., roughly 52 minutes later.  P. Br. at 4, 8, 13; P. Reply at 3-4; P. Ex. 29.  RN Behrns did not have her pager and, that is, more likely than not, why she was unaware of the call light activation.  P. Br. at 8-9; P. Ex. 25 at ¶¶ 5-6; Tr. 41-43, 110.  NA Alvarez did not notice that Resident 1’s call light was activated at 8:16 a.m. and did not discover that until a little after 9:00 a.m. on February 17, 2019, when she checked her pager.  P. Ex. 24 ¶¶ 5, 7.  According to Petitioner’s policy, NA Alvarez should have received the first page when the call light was activated at 8:16 a.m. on February 17, 2019.  Five minutes later, because the call light was unanswered, all NAs and nurse managers, not just RN Behrns and NA Alvarez, should have received a page.  If the call light was not answered after 10 minutes all NAs, nurse managers, and the Assistant Director of Nursing should have been notified according to Petitioner’s policy.  CMS Ex. 6.  The evidence permits the inference that between 8:16 a.m. and 8:26 a.m. several members of Petitioner’s staff failed to respond to Resident 1’s call light, not just NA

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Alvarez and RN Behrns.13  Petitioner does not offer any evidence, just speculation, for why none of Petitioner’s staff who should have received pager notifications responded when Resident 1 activated her call light.

Due to the failure of Petitioner’s call light system to alert staff when Resident 1 called for assistance, Resident 1 did not receive effective supervision and assistance to prevent her accidental fall when she attempted to transfer and ambulate without assistance.  Due to her fall, Resident 1 suffered pain in her head and knee which I conclude was more than minimal harm.

There is no evidence of the professional standard of care for responding to call lights.  However, the Board has stated 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 has issued numerous decisions in which it found it appropriate to use a SNF’s policy to judge whether the SNF was compliant with regulatory participation requirements, 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. 6, reflects the professional standard of quality that Petitioner’s residents’ call lights, used as assistance devices, must be answered timely, by team members alerted by pagers.  Timeliness is not defined by Petitioner’s policy, but I find that failure to respond in fewer than 52 minutes is not timely.  The fact that Resident 1 did not receive adequate supervision and assistance consistent with professional standards further supports my conclusion that Petitioner violated 42 C.F.R. § 483.25(d).  As already explained, Resident 1 was at risk for more than minimal harm due to the regulatory violation.

Petitioner argues there was no lack of supervision and no noncompliance as alleged in the SOD under Tag F689 because staff did check on Resident 1.  Petitioner argues that staff simply forgot to turn off the call light and Resident 1 was only on the floor for a few minutes after her fall.  P. Br. at 5, 8-9; P. Reply at 2-3.  Whether Resident 1 lay on the floor for 52 minutes or five minutes is not material.  What is material is that Resident 1

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fell to the floor when she received no supervision and assistance with transferring and ambulation in response to activating her call light.

Petitioner argues that what is “adequate supervision and assistance devices” under the regulation is ambiguous.  P. Br. at 10-12.  The regulation is specific that supervision and assistance by a long-term care facility must be adequate to prevent accidents.  The regulation requires that the level of supervision and assistance is to be determined by the resident’s IDT based on professional standards, the resident’s comprehensive care plan, and resident choices.  The care plan is based on the resident’s assessed medical, nursing, mental, and psychosocial needs.  42 C.F.R. §§ 483.21(b)(1)-(2), 483.25(d).  There is no ambiguity that Resident 1’s IDT determined she was at risk for falls and required that supervision and assistance with transfers and ambulation be provided in response to the resident using her call light to summon Petitioner’s staff.  Petitioner’s call light system failed to alert Petitioner’s staff to the fact Resident 1 required supervision and assistance with transferring and ambulation on February 17, 2019, at 8:16 a.m.  As a result of the failure of the call light system, Petitioner failed to deliver adequate supervision and assistance for Resident 1.  The failure of Petitioner’s staff to respond to the call light is not negated by the facts that staff checked on Petitioner and thought she was still sleeping, and staff believed Resident 1 did not want to be disturbed while sleeping.  P. Br. at 5, 13.  Resident 1 activated her call light to signal staff that she needed assistance and the fact she may have dozed-off waiting, does not permit the inference she no longer needed assistance.  Had staff timely responded to the call light as required by its policy and given Resident 1 the supervision and assistance she needed to transfer and ambulate to use the bathroom, the fall and related risk for harm may have been avoided.

Petitioner also argues that Resident 1 suffered no harm from the fall.14  P. Br. at 9-10, 13-16; P. Reply at 4.  Petitioner’s portrayal is that Resident 1 was okay after her fall but then during transport to the emergency room EMS administered Narcan® pursuant to EMS protocol and that resulted in Resident 1 becoming unconscious and caused Resident 1 to be intubated in the emergency department.  The gist of Petitioner’s argument is that the administration of Narcan®, the resident’s subsequent unconscious state, and the need to intubate her in the hospital, was not harm.  If the need to administer Narcan®, the resident’s unconscious state, and the need to intubate was harm, Petitioner’s view is that

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the harm was not attributable to the fall at Petitioner and Petitioner should not be held responsible for that harm.  P. Br. at 3.  The facts are inconsistent with Petitioner’s views.

Resident 1 activated her call light at 8:16 a.m. on February 17, 2019 (P. Br. at 4; P. Reply at 3; P. Ex. 29);
	Petitioner’s staff did not respond to the call light for more than 50 minutes (P. Br. at 8, 13; P. Reply at 3; P. Ex. 29);
	Roughly 45 minutes after activating her call light, Resident 1 fell while trying to transfer and ambulate without supervision or the assistance of staff (P. Reply at 5; P. Ex. 18 at 7);
	Because she was on antiplatelet therapy Petitioner’s protocol required that Resident 1 be sent to the emergency room per Administrator Weston and the order of the nurse practitioner on duty (Tr. at 91; P. Ex. 18 at 7; P. Br. at 6, 10);
	EMS administered Narcan® as part of their protocol because Resident 1 seemed to be in a reduced state of consciousness or unconscious (P. Br. at 7);
	Resident 1 was intubated at the emergency room consistent with protocol, because she was unconscious, was on antiplatelet therapy, and had fallen and claimed she hit her head (Tr. 68; P. Br. at 7); and
	Intubation as described by Dr. Hatcher is an invasive medical procedure that requires paralyzing the diaphragm and inserting a tube in the airway to control breathing which he admitted, is a shocking procedure for a layperson (Tr. 68, 70).These undisputed facts establish the direct connection between the failure of Petitioner’s staff to answer Resident 1’s call light and provide her requested supervision and assistance with transferring and ambulating and the invasive treatment Resident 1 received at the hospital.  I conclude that the facts show that falling posed a risk for more than minimal harm and that Resident 1 suffered more than minimal harm.

However, even if one did not attribute what happened to Resident 1 at the emergency department to Petitioner, Resident 1 was at risk for and suffered more than minimal harm due to Petitioner’s regulatory violation.  Upon being discovered on the floor of her room, Resident 1 told staff that she was experiencing both head and knee pain.  P. Ex. 18 at 7.  Petitioner attempted to minimize Resident 1’s complaints of pain through Administrator Weston’s testimony that the resident had verbalized complaints of pain at different times (Tr. 91), but Petitioner has presented no evidence Resident 1 did not experience head and knee pain due to her fall on February 17, 2019.  Petitioner has presented no evidence or authority to support a position that pain is not more than minimal harm, i.e., actual harm.

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Petitioner also argues that the surveyor failed to perform an adequate investigation.  Petitioner focuses on the fact that Surveyor Frodsham did not interview all witnesses and her inconsistent allegations.  P. Br. at 16-17; P. Reply at 4.  Pursuant to 42 C.F.R. § 488.318(b), inadequate survey performance does not relieve a long-term care facility of its obligation to meet all program participation requirements or invalidate adequately documented citations of noncompliance.  My review is de novo.  Based on my de novo review, I conclude that noncompliance under Tag F689 is adequately documented in this case.  Petitioner’s argument that Surveyor Frodsham did an inadequate investigation, even if true, does not affect the outcome in this case.  Indeed, the Board has concluded that allegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS noncompliance and enforcement remedy determinations.  *Avon Nursing Home*, DAB 2830 at 10-11 (2017).  Petitioner also suggests that the changing positions of the surveyor made it “virtually impossible” for Petitioner to receive adequate notice of the factual basis for the citation of noncompliance.  P. Br. at 14.  The SOD adequately informed Petitioner that noncompliance was cited under Tag F689 based on a violation of 42 C.F.R. § 483.25(d) and that the noncompliance caused Resident 1 actual harm.  CMS Ex. 1 at 4; P. Ex. 10 at 4.  The fact that Surveyor Frodsham chose to focus on various evidence of harm in the SOD, in discussions with Petitioner’s staff, and at hearing did not deprive Petitioner of adequate notice of what to defend.  Petitioner’s presentation of its defense in this case belies any allegation Petitioner did not know what to defend.

**3.  A CMP of $1,550 per day from March 12 through April 10, 2019, is a reasonable enforcement remedy.**

Petitioner argues that the amount of the CMP proposed by CMS is unreasonable because Resident 1 suffered no harm.  RFH at 4 ¶ 8b, 5 ¶ 10; P. Br. at 16-17; P. Reply at 5.  In its reply brief, Petitioner explains that its argument is the CMP is unreasonable because there is no basis for the imposition of an enforcement remedy, i.e., Petitioner’s position is that there is no noncompliance under Tag F689 because Petitioner provided adequate supervision and Resident 1 suffered no harm.  P. Reply at 5.  I have rejected Petitioner’s arguments.  I have concluded that Petitioner violated 42 C.F.R. § 483.25(d)(2) (Tag F689), and that the violation posed a risk for more than minimal harm to Resident 1.  The violation of the regulatory participation requirement and risk for more than minimal harm amount to noncompliance that is a basis for the imposition of enforcement remedies.  42 C.F.R. § 488.402(b)-(c).  If a facility is not in substantial compliance with program participation 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.  42 C.F.R. § 488.430(a).  I conclude that there is a basis for the imposition of an enforcement remedy in this case because there was noncompliance with a program participation requirement.

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When I conclude 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 electing 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, i.e., scope and severity, of the deficiencies as defined by 42 C.F.R. § 488.404(b) 15 (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 scope and severity 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.

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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 do not review whether CMS properly considered the regulatory factors.  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).

In this case, CMS proposed a $1,550 per day CMP based on noncompliance under Tag F689 at a scope and severity of G, which indicates that the noncompliance was isolated and caused actual harm that was not immediate jeopardy.  CMS Ex. 2 at 1; P. Ex. 11 at 1.  On April 22, 2019, the date of the CMS initial determination, CMS was authorized to impose a per day CMP in the lower range of CMPs of $107 to $6,418 per day, for noncompliance that did not pose immediate jeopardy.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2018).  Therefore, the CMP proposed by CMS is in the lower quarter of the authorized range for a CMP.

I consider the regulatory factors as follows:

CMS has presented no evidence regarding Petitioner’s history of noncompliance.
	Petitioner has presented no evidence regarding its financial ability to pay the CMP.
	Petitioner’s noncompliance is serious.  Petitioner failed to ensure that Resident 1 received adequate supervision and assistance to prevent her from falling and suffering injury.  Resident 1’s IDT, recognizing her risk for falling had developed a care plan that required that staff encourage the resident to use her call light and to provide assistance with toileting and transfers.  Resident 1 had a history of using her call light correctly and effectively.  Petitioner’s staff failed to respond when Resident 1 used her call light, which resulted in Resident 1 attempting to self-transfer and ambulate without assistance, which resulted in Resident 1 falling, which caused Resident 1 to suffer head and knee pain, which I consider to be actual harm.
	Petitioner was culpable for its noncompliance, which involved multiple members of its staff failing to follow Petitioner’s policy to use pagers to ensure staff responded to Resident 1’s call for assistance in a timely manner.Page 22

The failure to provide Resident 1 with adequate supervision and assistance was an isolated incident that caused actual harm to Resident 1, i.e., head and knee pain.16CMS proposed a per-day CMP of $1,550 for 29 days of nonimmediate jeopardy noncompliance from March 12 through April 10, 2019.17  CMS Exs. 2-3; P. Exs. 11-12.  I conclude that the CMP is within the authorized range.  I further conclude the CMP is reasonable based on my consideration of the regulatory factors.

III.     Conclusion

For the foregoing reasons, I conclude that:

Petitioner was not in substantial compliance with program participation requirements from March 12 through April 10, 2019, due to a violation of 42 C.F.R. § 483.25 (Tag F689), which posed a risk for more than minimal harm; and

A CMP of $1,550 per day from March 12 through April 10, 2019, is a reasonable enforcement remedy.

Endnotes

1 References are to the October 1, 2018 revision of the Code of Federal Regulations (C.F.R.) which was in effect at the time of the March 13, 2019 survey, unless otherwise indicated.  *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).

2 This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities.  The current version of the SOM is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.  The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. *Ind. Dep’t of Pub. Welfare v. Sullivan*, 934 F.2d 853 (7th Cir. 1991); *Nw. Tissue Ctr. v. Shalala*, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, the Secretary may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

3 SNFs and nursing facilities (NFs) are often referred to as long-term care facilities or nursing homes.  NF participation 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.

4 Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.

5 “Credible evidence” is evidence that is worthy of belief.  *Black**’**s Law Dictionary* 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  *Id*. at 1625.

6 Petitioner’s clinical notes for Resident 1 also show that on February 21, 2019, Resident 1 rolled out of her bed while trying to retrieve her bed control that had fallen to the floor.  She received abrasions above and below her right eye which the resident reported happened when her head hit the side of her bed during the fall.  Resident 1 was again sent to the emergency room for evaluation.  A note dated February 25, 2019, at 4:11 p.m. shows that pressure alarms were in use in the resident’s bed and wheelchair at all times for safety until March 6, 2019, when they were removed because the resident was compliant.  P. Ex. 18 at 8-11; CMS Ex. 4 at 41-42.  Surprisingly, the February 21, 2019 fall is not mentioned in the Statement of Deficiencies (SOD) for the survey completed on March 13, 2019.  CMS Ex. 1.  The implementation of pressure alarms as a fall prevention intervention is not mentioned in the Resident 1’s care plan.  CMS did not make allegations before me related to the February 21, 2019 fall or the implementation of pressure alarms or their omission from the care plan.  Therefore, I do not consider the February 21, 2019 fall or the late implementation of pressure alarms to address Resident 1’s fall risk as further evidence of noncompliance in this case.

7 A “Customer Concern Form” dated February 18, 2019, indicates Resident 1’s daughter complained that Resident 1 told her that the resident waited over an hour before attempting to transfer herself.  I infer that the daughter was referring to the incident on February 17, 2019, when Resident 1 fell.  The form indicates that Petitioner did investigate and analyze the situation related to Resident 1’s call light and her fall and took some corrective action.  P. Ex. 14; CMS Ex. 4 at 1.

8 CMS did not object to the affidavits.  RN Behrns was subject to cross examination at the hearing.  CMS waived the right to cross-examine the other three witnesses by not objecting to the admission of their affidavits or declarations.

9 EMS records show that EMS personnel questioned whether Resident 1 was truly unconscious when they transported her to the hospital or whether she was just pretending as suggested by Petitioner’s staff when EMS personnel arrived at Petitioner.  P. Ex. 31 at 4.  It is significant to note that EMS staff did not attempt to resolve their doubt choosing to administer Narcan® and treat the resident according to EMS protocol rather than ignoring possible signs and symptoms of unconsciousness.  It is undisputed that the decision to treat the resident according to what EMS observed more likely than not caused her to be intubated when she arrived at the emergency room (P. Ex. 32 at 10).

10 It is not clear from the evidence when the care plan became effective.  However, there is no dispute it was in effect on February 17, 2019, when Resident 1 fell.

11 P. Ex. 29 shows that from February 15, 2019, to 8:16 a.m. on February 17, 2019, Petitioner’s staff responded to the call light for Resident 1’s room within a few seconds to just under eight minutes.  Tr. 85.  The evidence shows that Resident 1 had a history of using her call light to call for staff assistance rather than trying to get out of bed and walk on her own.  In fact, Petitioner’s evidence shows that the call light in Resident 1’s room was activated eight times between 12:19 a.m. and 8:16 a.m. on February 17, 2019.  P. Ex. 29.

12 Surveyor Frodsham alleged in the SOD that Petitioner “failed to provide supervision and care to prevent a fall with injury” to Resident 1.  CMS Ex. 1 at 4; P. Ex. 10 at 4.  Surveyor Frodsham testified that she did not identify any harm until she learned that Resident 1 was intubated.  Tr. 25-26.  In response to my questions, she clarified that she found that the fact the resident was unconscious or had diminished responsiveness when EMS personnel arrived showed that the resident suffered harm due to the fall.  Tr. 31-32.  Surveyor Frodsham did not testify or state in the SOD that Resident 1’s complaints of head and knee pain were evidence Resident 1 suffered more than minimal harm.  Nevertheless, Resident 1’s complaints of pain are evidence that she more likely than not suffered more than minimal harm, i.e., actual harm, due to her fall on February 17, 2019.

13 Administrator Weston testified that there were three NAs and two nurses on duty in the area where Resident 1 lived the morning of February 17, 2019.  Tr. 85.  Petitioner concedes that despite her investigation, Administrator Weston could not explain why Resident 1’s call light was not answered by anyone.  P. Br. at 8.

14 Petitioner refers to the definition of serious bodily injury in the SOM.  P. Br. at 12-13; P. Reply at 5; P. Ex. 33.  However, Petitioner does not cite authority or explain how the definition applies in this case.  Noncompliance exists when a violation of a statutory or regulatory participation requirement poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  There is no authority that requires that a risk for serious bodily injury or actual serious bodily injury exist for a long-term care facility to be determined not to be in substantial compliance with program participation requirements.

15 Scope and severity 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.

16 Petitioner raises no challenge to the scope and severity determination in this case.  The conditions that would permit such a challenge do not exist in this case.  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.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).

I also do not consider Resident 1’s fall with injury on February 21, 2019, in deciding the reasonableness of the CMP.  P. Ex. 18 at 9.

17 Resident 1’s fall and injury occurred on February 17, 2019.  The CMS initial determination (CMS Ex. 2; P. Ex. 11) does not explain why CMS determined to begin the CMP on March 12, 2019, rather than February 17, 2019.  However, no issue regarding the beginning of the period of accrual of the CMP is before me.
  
          /s/
        Keith W. Sickendick

                      Administrative Law Judge Back to top
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