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                              Generations at Lincoln, DAB CR6023 (2022)
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Generations at Lincoln, DAB CR6023 (2022)








  
  
    

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





Generations at Lincoln
(CCN:  14-5719),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-19-647Decision No. CR6023February 1, 2022

        
              
    

      DECISION

Petitioner, Generations at Lincoln, was not in substantial compliance with program participation requirements on December 31, 2018, due to a violation of 42 C.F.R. § 483.25(d)(2),1
 as cited by the survey completed on January 30, 2019; and from February 11 through March 21, 2019, based on violations of 42 C.F.R. §§ 483.10(g)(14)

Page 2

and 483.25(b)(1) as cited by the survey completed on February 13, 2019.  There is a basis for the imposition of a per instance civil money penalty (PICMP) of $13,780 based on the noncompliance that occurred on December 31, 2018 as cited by the January 30, 2019 survey and a per day civil money penalty (CMP) of $935 for the period February 11 through March 21, 2019, based on the noncompliance cited by the survey completed on February 13, 2019.

I.  Background

Petitioner is located in Lincoln, Illinois and participates in Medicare as a skilled nursing facility (SNF).  On January 30, 2019 and February 13, 2019, Petitioner was surveyed by the Illinois Department of Public Health (state agency) and found not in substantial compliance with program participation requirements.  Joint Stipulations of Undisputed Fact (Jt. Stip.) ¶¶ 1-5; Centers for Medicare & Medicaid Services (CMS) Exhibits (Exs.) 1-2.  The state agency completed a third complaint survey on March 7, 2019.  The surveyors concluded that there was continuing noncompliance by Petitioner.  CMS Exs. 3, 12.  Based on an April 2, 2019 revisit survey, the state agency concluded that Petitioner returned to substantial compliance effective March 22, 2019.  CMS Exs. 4, 12.

On March 8, 2019, CMS notified Petitioner that it was imposing a PICMP of $13,780 for the violation of 42 C.F.R. § 483.25(d)(2) alleged by the December 31, 2018 survey, and a CMP of $935 per day effective February 11, 2019 and continuing until Petitioner returned to substantial compliance or its participation in Medicare was terminated, for the violations of 42 C.F.R. §§ 483.10(g)(14) and 483.25(b)(1) alleged by the survey completed on February 13, 2019.  CMS also noted that the state agency imposed a discretionary denial of payment for new admissions (DPNA) effective April 20, 2019.  CMS Ex. 11.  CMS notified Petitioner on April 19, 2019, that a revisit survey completed on March 22, 2019, determined that Petitioner returned to substantial compliance effective March 22, 2019.  CMS advised Petitioner that the discretionary DPNA imposed by the state agency did not go into effect and was rescinded.  CMS advised Petitioner that the $935 per day CMP based on the February 2019 survey ran from February 11 through March 21, 2019, and that the $13,780 PICMP based on the January 2019 survey was unchanged.  CMS Ex. 12.

Petitioner requested a hearing before an administrative law judge (ALJ) on April 5, 2019.  The case was assigned to me for hearing and decision on April 12, 2019, and an Acknowledgement and Prehearing Order was issued at my direction.  On September 9, 2019, the parties filed a joint settlement status report in which they waived an oral hearing and requested a decision on the briefs.  On September 20, 2019, I issued an order accepting the waiver of oral hearing and set a briefing schedule.

Petitioner filed its opening brief on the merits on November 19, 2019 (P. Br.).  CMS filed its opening brief on November 19, 2019 and its amended opening brief on November 25,

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2019 (CMS Br.).  Each party filed proposed findings of fact and conclusions of law.  Petitioner filed a reply brief on December 18, 2019 (P. Reply).  CMS filed a reply brief on December 19, 2019 (CMS Reply).

CMS filed CMS Exs. 1 through 34 on July 9, 2019, and CMS Exs. 35 and 36 on November 25, 2019.2
  On September 9, 2019, Petitioner filed objections to CMS Exhibits (Exs.) 1 through 3, 15, 16, 18, 19, 26, and 27 on grounds that the documents include hearsay.  The objections are overruled.  Petitioner is correct that the documents all include and are mostly hearsay.  However, evidence is not excluded on the basis that it is hearsay so long as it is relevant and authentic.  Rather, I consider the hearsay nature of evidence when determining how to weigh the evidence.  On December 5, 2019, Petitioner objected to CMS Ex. 35, the declaration of Surveyor Staci Byers, Registered Nurse (RN).  Petitioner specifically objects to statements of Surveyor Byers in paragraph 9, sections (a) through (f), on the basis of speculation, and paragraph 10, sections (a)(ii) and (b)(i) on the basis of hearsay.  CMS Ex. 35 does contain hearsay.  However, hearsay is admissible so long as it is relevant and authentic, and Petitioner’s objection goes to the weight to be accorded the evidence rather than its admissibility.  Therefore, the hearsay objection is overruled, and I will determine the appropriate weight to be accorded to the hearsay.  Further, Surveyor Byers’ testimony is not speculative, rather she is stating the bases for her findings and conclusions that Petitioner violated 42 C.F.R. § 483.25(d)(2), and her opinions are relevant and important to judging the merits of the citation of noncompliance.  Accordingly, Petitioner’s objection to CMS Ex. 35 is overruled.  CMS Exs. 1 through 36 are admitted and considered as evidence.  Petitioner did not file exhibits but informed me it chose to rely upon the documentary evidence filed by CMS.  Generations at Lincoln’s List of Proposed Exhibits filed August 12, 2019.  I further note that by waiving oral hearing Petitioner waived the right to cross-examine the surveyors whose declarations are in evidence as CMS Ex. 35 and 36.

II.  Discussion

**Issues**Whether there is a basis for the imposition of an enforcement remedy; and,

Page 4

Whether the remedy imposed is reasonable.

**Applicable Law****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 DPNA.  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

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

Page 5

statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

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

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,525 per day to $21,393 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.4
  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2019).  “*Immediate jeopardy* means a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301 (emphasis in original).  The lower range of CMPs, $107 per day to $6,417 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2020).  CMS is also authorized to impose a PICMP in the range of $2,140 to $21,393, for an instance of noncompliance.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2).

Petitioner was notified in this case that it may be ineligible to conduct a nurse aide training and competency evaluation program (NATCEP).  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to

Page 6

42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $10,697 (45 C.F.R. § 102.3 (Table)) (2019); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements.  “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  The CMP proposed by CMS triggers the ineligibility to be approved to conduct a NATCEP in this case.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination).

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

**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).

Page 7

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.5
  Rather, the Board has long held that the petitioner, i.e., the nongovernmental party, 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. 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 a prima facie case of noncompliance with a regulatory requirement.”  *Id.*;

Page 8

*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 the burden shifts to Petitioner or not.  It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.  In this case based on the following analysis, I conclude that CMS has made its prima facie showing of noncompliance by a preponderance of the evidence.

**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, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence given the greatest weight in my decision-making.6
  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 to 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., Administrative Law and Practice § 5:64 (3d ed. 2013).

This case involves noncompliance cited by a survey of Petitioner that ended January 30, 2019 (CMS Ex. 1), a survey that ended on February 13, 2019 (CMS Ex. 2), and a survey completed on March 7, 2019, that found continuing noncompliance.  The survey that ended on January 30, 2019, cited Petitioner for violations of 42 C.F.R. §§ 483.10(g)(14) (Tag F5807
 , at a scope and severity level (s/s) D);8
 483.25(d) (Tag F689, s/s G); and

Page 9

483.45(c)(3)(e) (Tag F758, s/s level D).  CMS Ex. 1.  The survey that ended on February 13, 2019, cited Petitioner for violations of 42 C.F.R. §§ 483.10(g)(14) and (15)9
 (Tag F580, s/s level D), and 483.25(b)(1) (Tag F686, s/s G).  CMS Ex. 2.  The survey completed on March 7, 2019, cited Petitioner for continuing noncompliance under Tag F686 based on a violation of 42 C.F.R. § 483.25(b)(1) that posed a risk for more than minimal harm (s/s D), but related to a different resident than the resident involved in the survey completed on February 13, 2019.10
  CMS Ex. 3 at 3-5.  CMS imposed a PICMP of

Page 10

$13,780 for the instance of noncompliance cited under Tag F689 by the January 30, 2019 survey.  CMS imposed no enforcement remedy based on the alleged noncompliance by the January 2019 survey under Tags F580 or F758 and the allegations of noncompliance under those Tags are not subject to my review.  CMS Ex. 11; 42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13).  Therefore, with respect to the January 2019 complaint survey, only the noncompliance based on the alleged violation of 42 C.F.R. § 483.25(d)(2)11
 is at issue before me.  With respect to the February 2019 complaint survey, the noncompliance based on the alleged violations of 42 C.F.R. §§ 483.10(g)(14)12
 (Tag F 580) and 483.25(b)(1) (Tag F686) are at issue before me.  The enforcement remedies at issue are the proposed $13,780 PICMP and the proposed $935 per day CMP for 39 days from February 11 through March 21, 2019.

**SURVEY COMPLETED JANUARY 20, 2019**

**Petitioner violated 42 C.F.R. § 483.25(d)(2) (Tag F689) in the case of Resident 2.
	The violation of 42 C.F.R. § 483.25(d)(2) caused actual harm to Resident 2 and amounted to noncompliance under Tag F689.**The surveyors cited Petitioner related to the examples of Resident 2 and Resident 5.  The example of Resident 2 amply demonstrates the noncompliance.  Therefore, the example of Resident 5 is not discussed.

Page 11

**Facts**A minimal number of clinical records for Resident 2 were placed in evidence by CMS13
 and none were provided by Petitioner.  But there is little dispute as to what happened to Resident 2.

Resident 2, a male, was 61 years old when he was admitted to Petitioner on November 9, 2018.  CMS Ex. 14 at 9, 14, 16, 42.  Resident 2 had multiple medical issues when he was admitted to Petitioner including a recent hospitalization for acute on chronic respiratory failure.  CMS Ex. 14 at 10, 42, 56.  Resident 2’s diagnoses included a fracture of the shaft of his right fibula.  CMS Ex. 14 at 56, 69-72.  A progress note printed on November 9, 2018 and based on a physician visit on November 7, 2018, indicates that Resident 2 had a fracture described as a right distal fibular fracture that was casted on October 19, 2018, and a probable osteophyte avulsion fracture at the suprapatellar area.  CMS Ex. 14 at 42, 56.  Resident 2 could not bear weight on his right leg.  CMA Ex. 14 at 56, 69.  An orthopedic surgeon who saw Resident 2 on January 29, 2019, described the resident’s fracture as being at the right ankle.  The physician stated Resident 2 was in the nursing home to learn to walk again.  CMS Ex. 14 at 75.  Due to his fracture Resident 2 used a wheelchair for mobility.  CMS Ex. 14 at 28.

No care plans addressing Resident 2’s right leg fracture or his use of a wheelchair are in evidence.14
  There are also no contemporaneous nursing notes in evidence that address an assessment of Resident 2 following the incident on December 28, 2018.

A physical therapy note dated December 28, 2018, shows that Resident 2 was injured when his right leg was pulled under his wheelchair.  CMS Ex. 14 at 59.  It is not indicated that the physical therapy session was altered on account of the accident.  CMS Ex. 14 at 59.

Page 12

A record of an interview of Resident 2 was placed in evidence by CMS, and Petitioner has not contested its accuracy or rebutted its content.  The document reflects that Resident 2 was alert and oriented at the time of the interview.  The document also reflects that the interview was conducted on New Year’s Day.  The statement indicates that the interview was triggered by Petitioner’s report to management that a certified nursing assistant (CNA) “was talking back” to Resident 2, and that the CNA was suspended pending investigation.  CMS Ex. 14 at 50.  Resident 2 stated that he and the CNA were in a hurry and forgot to put the leg-rests on the wheelchair.  He stated his right leg got caught under the wheelchair rails.  He stated therapy was aware and that he was okay.  The document reflects that the CNA was separately interviewed, and she denied being disrespectful to the resident.  Another CNA was also interviewed, and she indicated that the CNA who was the focus of the investigation was not disrespectful.  The document indicates it was prepared by Lynnette Torres, SVP.15
  CMS Exs. 14 at 50; 15 at 12.  According to other evidence in the record, Ms. Torres is a registered nurse employed by Petitioner.  CMS Ex. 15 at 17.  The records of interviews by Petitioner’s staff member are considered weighty as this evidence is consistent with other evidence of record related to the December 28, 2018 entrapment of Resident 2’s right leg under his wheelchair.

An x-ray of Resident 2’s right knee was done on December 28, 2012, following the entrapment of his right leg under the wheelchair.  No fracture or dislocation was identified.  However, the report states that further radiographs in one week were warranted if there was further concern about the knee or worsening of symptoms.  CMS Ex. 14 at 49.

The record includes a form titled “Concerns” dated December 28, 2018, completed by Amanda Bradburn, whose position with Petitioner is not indicated.  The form states that a CNA was pushing Resident 2 in his wheelchair when his right leg went under his wheelchair twisting the leg back.  The report indicates no swelling, no bruising, and no complaints of pain were noted.  The report also indicates that the resident’s physician was notified.  Under actions taken is the statement that the x-ray was clear, no further orders would be given, and staff were to continue to monitor.  CMS Ex. 15 at 13, 15.

There is no further evidence of evaluation or treatment of Resident 2’s right knee until an MRI was performed on about January 18, 2019.  CMS Ex. 14 at 45-48, 55, 74-76.  The

Page 13

reason for the study was “[p]ain in the right knee throughout the entire knee after twisting 2 weeks ago.”  CMS Ex. 14 at 45, 54.  The MRI shows Resident 2 had severe arthritic changes in his right knee and medial and lateral meniscus tears.  CMS Ex. 14 at 46-47, 51-52, 76.  On January 29, 2019, an orthopedic surgeon, reviewed x-rays (I infer the x-ray from December 28, 2018) and an MRI (I infer the MRI from January 18, 2019).  The physician observed that Resident 2 had medial and lateral meniscal tears of the right knee visible on the MRI.  He noted that Resident 2 complained of acute pain.  The physician stated in his progress note that he could not tell if the tears were old or new.  The decision was made to treat Resident 2’s pain with an intraarticular injection of steroids in the right knee.  CMS Ex. 14 at 41, 45-48, 55, 74-76.

On January 29, 2019, Surveyor Staci Byers interviewed the CNA who was pushing Resident 2 in his wheelchair when the incident occurred on December 28, 2018.  She stated that Resident 2 had his boot (I infer an orthopedic boot) on his right foot when it became entangled under his wheelchair.  The CNA told the surveyor that Resident 2 did yell in pain when his foot became entangled, and she had to have a nurse assist her in freeing Resident 2’s foot.  The CNA admitted that Resident 2 had footrests for his wheelchair, but she did not put them on.  CMS Ex. 15 at 1.  Despite the hearsay nature of the statement of the CNA, I find it credible and weighty as it is consistent with other evidence of record.  I further note Petitioner waived the opportunity to call the CNA to testify at an oral hearing.

Physical therapy treatment notes show no complaints of pain with movement of Resident 2’s lower extremities on December 24 and 26, 2018.  A note on December 28, 2018, records that that morning Resident 2’s right leg had been entrapped under his wheelchair.  The note records that the physical therapist used electric stimulation to reduce Resident 2’s knee pain.  CMS Ex. 14 at 59.  Resident 2 was also treated for knee pain by electric stimulation on December 31, 2018 and January 2, 2019.  CMS Ex. 14 at 60.  The physical therapy notes also record complaints of knee pain on January 7, 2019.  CMS Ex. 14 at 61.

A nurse practitioner (who Petitioner refers to as an orthopedic clinical nurse practitioner (P. Br. at 6)) reported to Surveyor Byers during an interview on January 28, 2019, that Resident 2 did not complain of knee pain before the incident on December 28, 2018.  She also opined that the entrapment of Resident 2’s foot on December 28, 2018, is consistent with the meniscus tear identified by the MRI on January 18, 2018.  She further opined that the injury caused a setback in Resident 2’s rehabilitation from his right leg fracture.  CMS Ex. 15.  Despite the hearsay nature of the statement, I find it credible and worthy of weight because it is consistent with other evidence.  I give weight to the opinions expressed as they are within the scope of expertise of a nurse practitioner.  The opinion that the meniscus tear is consistent with the December 28, 2018 entrapment is unrebutted by any evidence in the record.  Further, Petitioner waived the opportunity to call the nurse practitioner as a witness at an oral hearing.

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CMS placed in evidence a one-page document titled “Wheelchairs.”  CMS Ex. 20.  I infer the document was obtained by surveyors during the survey.  The document does not discuss the use of footrests on wheelchairs except to state they can be folded or swung to the side for easier access to the bed, toilet, or tub.  The document does not state when or if footrests must be used.  CMS Ex. 20.

Surveyor Byers opined in her declaration that Petitioner violated 42 C.F.R. § 483.25(d)(2) because Petitioner failed to ensure Resident 2 received adequate supervision and assistance devices by failing to ensure the footrests were used on Resident 2’s wheelchair.  She opined that the failure to use the footrests on December 28, 2018, resulted in Resident 2’s right foot becoming entangled under his wheelchair while a CNA was pushing him.  She further opined that basic safety principles for CNAs require that footrests on wheelchairs be used to elevate a resident’s feet to prevent entanglement.  CMS Ex. 35 at 2 ¶ 9.  Surveyor Byers, a registered nurse and trained surveyor (CMS Ex. 35 at 1 ¶¶ 2-5), has the knowledge and expertise to opine as to the proper use of footrests on wheelchairs.  Her opinion is not rebutted by any evidence in the record.  Surveyor Byers found that Resident 2 suffered actual harm in the form a meniscus tear in his right knee and a complaint of pain when the resident’s foot became entangled.  CMS Ex. 35 at 3 ¶ 10.  Surveyor Byers opinions are consistent with and supported by the evidence of record and are considered weighty.  Petitioner waived the opportunity to cross-examine Surveyor Byers by waiving an oral hearing.

**Analysis**The Statement of Deficiencies (SOD) alleges that Petitioner violated 42 C.F.R. § 483.25(d)(2) because Petitioner failed to ensure Resident 2 received adequate supervision and assistance devices to prevent accidents.  The surveyors allege more specifically that Petitioner failed to ensure that wheelchair footrests were used when Resident 2 was being pushed in his wheelchair, resulting in his foot becoming entrapped under the wheelchair with resulting pain and injury.  CMS Ex. 1 at 4-7.  Surveyor Byers made clear in her declaration that the surveyors concluded that Petitioner violated 42 C.F.R. § 483.25(d)(2) in this case.  CMS Ex. 36 at 2 ¶ 9.

The general quality of care requirement established by 42 C.F.R. § 483.25 is that a facility must ensure that it provides, and each resident receives “the necessary care and services to attain or maintain the [resident’s] highest practicable physical, mental, and psychosocial well-being, in accordance with the [resident’s] comprehensive assessment and plan of care.”  Regarding the prevention or avoidance of accidents 42 C.F.R. § 483.25(d) requires:

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

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(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).

The Board has previously stated that 42 C.F.R. § 483.25(d)16
 does not make a facility strictly liable for accidents that occur, but that the regulation does require that a facility take all reasonable steps to ensure that:  (1) a resident receives supervision and assistance devices that meet his or her assessed needs; and (2) mitigate foreseeable risks of harm from accidents.  *Woodstock Care Ctr.*, DAB No. 1726 at 28-30.  A facility is permitted the flexibility to choose the methods of supervision it uses to prevent accidents, but the chosen methods must be adequate under the circumstances.  Whether supervision is “adequate” depends in part upon a resident’s ability to protect himself or herself from harm.  *Id.*  Based on the regulation and the cases in this area, CMS meets its burden to make a prima facie case if the evidence demonstrates that the facility failed to provide adequate supervision and assistance devices to prevent accidents given what was reasonably foreseeable.  *Alden Town Manor Rehab. & HCC*, DAB No. 2054 at 5-12 (2006).  An “accident” is an unexpected, unintended event that can result in injury of a resident.  It does not include adverse outcomes that are a direct consequence of treatment or care provided in accordance with current standards of practice (e.g., drug side effects or reactions).  *Woodstock Care Ctr.*, DAB No. 1726 at 4.

In *Good Shepherd Home for the Aged, Inc.*, DAB No. 2858 (2018), an appellate panel of the Board discussed prior Board interpretations and applications of 42 C.F.R. § 483.25(h)(2) (now 42 C.F.R. § 483.25(d)(2)). which are summarized as follows:

Petitioner is required to provide supervision and assistance devices designed to meet the resident’s assessed needs and to mitigate foreseeable risks of harm from accidents.

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Petitioner must provide supervision and assistance devices to reduce known or foreseeable accident risks to the highest practicable degree consistent with accepted standards of nursing practice.

Petitioner is required to identify and assess foreseeable accident risks; determine what, if any, interventions are necessary and appropriate to mitigate the assessed risk; and take timely and effective steps to implement the chosen interventions.

Petitioner must furnish the care and services required by a resident’s care plan; implement doctor’s orders; monitor and document the resident’s condition; and follow its resident care policies.  Facility policy may be considered to be evidence of an appropriate standard of care and violation of a resident care policy may support a conclusion that a regulatory requirement is violated.

Petitioner’s failure to implement accident precautions its staff has determined to be necessary to mitigate an accident hazard without justifiable cause violates 42 C.F.R. § 483.25(d)(2).

*Good Shepherd*, DAB 2858 at 11-14; *Logan Healthcare Leasing, LLC*, DAB No. 3036 at 13-14 (2021).

It is necessary to apply the regulatory participation of 42 C.F.R. § 483.25(d)(2) as interpreted by the Board to the example of Resident 2.  I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(d)(2) and the violation caused actual harm to Resident 2.

The analysis in this case is not complicated.  Although there is no care plan in evidence reflecting the requirement, it is not disputed that Resident 2 required the use of a wheelchair for mobility, I infer due to the fracture of his lower right leg.  The wheelchair had footrests, which it is undisputed, were to be used to help keep Resident 2’s feet off the floor when the wheelchair was in use.  On December 28, 2018, a CNA failed to ensure Resident 2 was using the footrests when she was pushing him in the wheelchair.  As a result, Resident 2’s right foot became entrapped under the wheelchair while he was being pushed by the CNA.  The assistance device was the wheelchair and the wheelchair footrests.  The CNA was responsible to supervise Resident 2 in using the wheelchair safely.  Even if Resident 2 was in a hurry and did not want to use the footrests, the CNA had the responsibility to provide supervision and ensure safe use of the wheelchair.  The CNA failed to ensure the wheelchair footrests were in the proper position and that Resident 2’s right foot was properly placed on the footrests.  Resident 2’s right foot was entrapped.  Petitioner does not deny the accident occurred in this way.

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Petitioner argues in its defense that the accident caused no actual harm to Resident 2.  Petitioner argues that the meniscus tear shown by the MRI on January 18, 2019 was due to degenerative changes in Resident 2’s right knee rather than the entrapment of his right foot.  P. Br. at 3-7; P. Reply at 2-4.  Even if I accepted Petitioner’s argument that the meniscus tear was due to generative changes, the CNA admitted to Surveyor Byers that Resident 2 hollered in pain when his foot became entrapped.  CMS Ex. 15 at 1.  Physical therapy treatment notes show no complaints of pain with movement of Resident 2’s lower extremities on December 24 and 26, 2018.  A note on December 28, 2018, records that that morning Resident 2’s right leg had been entrapped under his wheelchair.  The note records that the physical therapist used electric stimulation to reduce Resident 2’s knee pain.  CMS Ex. 14 at 59.  Resident 2 was also treated for knee pain by electric stimulation on December 31, 2018 and January 2, 2019.  CMS Ex. 14 at 60.  The physical therapy notes also record complaints of knee pain on January 7, 2019.  CMS Ex. 14 at 61.  I have no difficulty concluding that the fact Resident 2 suffered knee pain which the evidence shows began when his right foot was entrapped on December 28, 2018, is actual harm, even if I accept Petitioner’s argument that the resident’s meniscus tear had another cause.

I do not, however, conclude that Petitioner has shown by a preponderance of the evidence that the meniscus tear suffered by Resident 2 was due to degenerative changes only and not the entrapment of Resident 2’s right foot.  Petitioner has not rebutted the evidence that Resident 2 suffered a meniscus tear in his right knee due to the entrapment.  Resident 2 expressed pain during the incident and physical therapy notes show that he continued to express that he was suffering right knee pain.  The fact that the x-ray following the incident did not show a meniscus tear does not satisfy Petitioner’s burden in this case.  Petitioner presented no evidence that an x-ray can show such an injury.  Petitioner has also presented no evidence to permit an inference based on the fact a meniscus tear was not shown by the x-ray makes it more likely than not that there was no such tear.  The orthopedic surgeon stated in his progress note that he could not tell if the tear was old or new.  The nurse practitioner interviewed by Surveyor Byers opined that the meniscus tear is consistent with the entrapment of Resident 2’s right foot.  Surveyor Byers also opined that that the tear was likely due to the entrapment.  Petitioner asserts that Petitioner’s medical director determined that Resident 2’s “injury was degenerative in nature” citing CMS Ex. 14 at 54.  P. Br. at 7.  CMS Ex. 14 at 54 is the first page of the report of the MRI done on January 18, 2019.  I infer that Petitioner is referring to a handwritten note on the face of the document that states “orthopedic to follow degenerative [lateral] meniscus tear,” followed by words I cannot decipher, and the note “1-24 faxed Attention:  Dr. Kureshey” and what appear to be initials.  CMS Ex. 14 at 54.  Dr. Kureshey was

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Petitioner’s medical director and Resident 2’s physician.17
  P. Reply at 3.  It is not possible for me to determine whether the hand-written opinion that Resident 2’s lateral meniscus tear was degenerative was the opinion of Petitioner’s medical director or the opinion who whomever sent the document by facsimile.  The results noted in the MRI report do not state that either the medial or lateral meniscus tears in the resident’s right knee were degenerative in nature.  CMS Ex. 14 at 52.  Furthermore, the orthopedic surgeon who saw Resident 2 on January 29, 2019, reported he reviewed the MRI and he specifically noted that he could not determine whether the medial and lateral meniscus tears of the resident’s right knee were old or current.  CMS Ex. 14 at 73-75.  Petitioner also points out that Resident 2 had a history of an injury to his right knee, specifically, an “osteophyte avulsion fracture at the suprapatellar area with his chronic severe osteoarthritis” citing CMS Ex. 14 at 56.  P. Br. at 7.  However, Petitioner presented no evidence that such a fracture is the same as a meniscus tear or could cause a meniscus tear.

Based on all the evidence, I conclude CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.25(d)(2) and that the violation caused actual harm to Resident 2.  Petitioner has not met its burden to show by a preponderance of the evidence that the accident involving Resident 2 and resulting injury was unavoidable.  Petitioner has not shown by a preponderance of the evidence that Resident 2 did not suffer actual harm.  In fact, Petitioner presented no evidence choosing to rely upon the evidence presented by CMS.  I conclude Petitioner has not met its burden to show that it remained in substantial compliance with the requirement of 42 C.F.R. § 483.25(d)(2) or to establish an affirmative defense.

**SURVEY COMPLETED FEBRUARY 13, 2019**

**Petitioner violated 42 C.F.R. § 483.25(b)(1)(i) (Tag F686) in the case of Resident 1.
	The violation of 42 C.F.R. § 483.25(b)(1) caused actual harm to Resident 1 and amounted to noncompliance under Tag F686.
	Petitioner has not met its burden to show that it returned to substantial compliance before March 22, 2019.**Page 19

**Facts**Resident 1, a male, was admitted to Petitioner from an acute care hospital on January 16, 2019.  He was 31 years old at the time of admission.  His diagnoses included a pervasive developmental disorder, a stable burst fracture of the T11-T12 vertebra with resulting paraplegia, major depressive disorder, and asthma.  He was required to wear a Thoracic Lumbar Sacral Orthosis (TLSO) back brace if out of bed.  CMS Ex. 25 at 110-112.  Resident 1 was totally dependent upon staff for his activities of daily living, including changing his position while in bed.  CMS Ex. 25 at 90.

Petitioner’s initial care plan for Resident 1 when he was admitted on January 16, 2019, shows he was assessed as at risk for pressure sores.  His admitting diagnoses listed a Stage 2 pressure ulcer on an “unspecified buttock” (CMS Ex. 25 at 42), however whether he actually had a pressure ulcer at admission is subject to conflicting evidence as discussed hereafter.  Several interventions were listed on that care plan including the requirement to reposition the resident every two hours.  CMS Ex. 25 at 42.

A comprehensive care plan was created on January 21, 2019, that addressed Resident 1’s risk for pressure ulcers stating the problem began on January 21, 2019.  The problem section lists current wounds on the left and right buttocks and the ischium.  CMS Ex. 25 at 11-13, 45-49.  The care plan description of the wounds is unclear as to whether there were two wounds, one on each buttock or a single wound that was in the area between and extended to each.  The ischium is a bony prominence at the bottom of the pelvic girdle, below the buttocks.  The care plan does not clearly indicate whether there was a separate wound in the flesh of the buttock over the ischium bone or whether this wound is the same as that referred to as being on the buttocks.  Interventions listed include a special cushion and mattress; the direction to staff to avoid shearing the resident’s skin during positioning, transfers, and turning; systematic skin inspections with particular attention to bony prominences; diet per physician orders; encouraging intake (of what is not specified) as the resident tolerates; using pillows and foam wedges, among other things to prevent direct contact between bony prominences; keeping the resident as clean and dry as possible; monitoring and reporting laboratory results; using lubricants and protective films and dressings and protective padding to reduce friction; reporting signs of skin breakdown; turning and repositioning as the resident tolerates; using absorbent pads/briefs; using pressure reduction when the resident is in his wheelchair; using heel protectors or pillows to relieve pressure on the resident’s heels as he tolerates; using moisture barrier product in the perineal area; and using pillows for offloading for pressure reduction while the resident is in bed.  CMS Ex. 25 at 11-13, 46-49.  This care plan did not require repositioning Resident 1 in bed or his wheelchair every two hours to offload or relieve the pressure on his rear.

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Petitioner created a care plan to address Resident 1’s risk for pressure ulcers.  CMS Ex. 25 at 1-2, 45-46.  The care plan states it was created on February 5, 2019, however that was after Resident 1 was transferred to the hospital and discharged from Petitioner.  The care plan states the problem started January 30, 2019 (CMS Ex. 25 at 1), which is clearly in error as Petitioner’s records show Resident 1 had redness on his buttocks as early as January 24, 2019 (CMS Ex. 25 at 131), if not before.  Because the care plan in evidence at CMS Ex. 25 at 1-2, is incorrect regarding the onset of the resident’s risk for ulcers and indicates it was not created until after the resident’s discharge, I do not accept the care plan as evidence of the plan of care for Resident 1 while he was residing with Petitioner.

Resident 1’s Minimum Data Set (MDS) dated January 23, 2019, five days after his admission, indicates that he had a Stage I pressure ulcer and was at risk for pressure ulcers.  CMS Ex. 25 at 86.  The MDS also indicates that Resident 1 was on a turning/repositioning program.  CMS Ex. 25 at 88.

A nurse progress note dated January 16, 2019, states that an initial skin check was completed but the results of the check are not specifically stated.  The note states that wound care orders are for nystatin powder to be applied to Resident 1’s groin to address a rash, and that the resident’s back incision was healed.  CMS Ex. 25 at 111.  I infer no pressure sores were noted during the skin check on January 16, 2019, because no pressure ulcer or sore was mentioned.

An observation report dated January 17, 2019, recorded that Resident 1 had redness on his buttocks and that barrier cream was ordered, but also indicated that the resident was not in the turning and repositioning program.  The form is not specific as to where on Resident 1’s buttocks the redness was.  The form does not indicate whether the redness persisted after the resident was moved off his buttocks and the pressure on his buttocks was relieved.  The form is marked to indicate that Resident 1 had no pressure ulcer at the time, which would be consistent with the fact that the redness disappeared after pressure was removed from the skin.  CMS Ex. 25 at 50, 98-99.

A skin assessment performed on January 24, 2019, documents redness on Resident 1’s buttocks and does not state whether the redness persisted after the resident was repositioned off his buttocks.  The form suggests that the redness extends to both buttocks and does not indicate whether the redness was observed between the buttocks, or whether it covered the entirety of the buttocks.  CMS Ex. 25 at 56, 131.

An observation report dated January 25, 2019, records that after being positioned with pressure on his buttocks for two hours Resident 1 had redness on his buttocks over the

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bony prominence.  However, the form indicates that when the same area was reevaluated, one hour after the pressure was relieved, the redness went away.  The form is marked to indicate that a two-hour repositioning schedule was required for Resident 1.  CMS Ex. 25 at 57, 94.  I find no evidence that the interdisciplinary team (IDT) 18
 considered this evaluation or that it was brought to the attention of the physician for consideration when he issued his order on January 27, 2019, to reposition/offload only as possible each shift (CMS Ex. 25 at 59).

A nurse progress note dated January 27, 2019 at 2:47 p.m. shows that on that day Licensed Practical Nurse (LPN) Taylor was informed by the day-shift nurse that Resident 1 had a wound on his buttocks but where is not stated.  LPN Taylor spoke with Petitioner’s administrator and then contacted the wound care nurse for treatment instructions.  The wound treatment nurse ordered application of thick layers of zinc every shift; to keep the resident lying on his sides not his back; and the resident was to be up in his wheelchair only for meals.  The note indicates LPN Taylor went to Resident 1’s room and applied the treatment and also informed the resident’s power of attorney holder of the change in orders as she was present with the resident at the time.  The note does not indicate that Resident 1’s physician was notified or consulted.  CMS Ex. 25 at 108.  I note that the evidence includes no care plan for Resident 1 that includes the interventions directed by the wound care nurse in her conversation with LPN Taylor on January 27, 2019, i.e., that thick layers of zinc should be applied every shift; that the resident should be kept lying on his sides not his back; and that the resident was to be up in his wheelchair only for meals.  CMS Ex. 25 at 108.  The evidence does not show that Resident 1’s IDT met and determined that the wound care nurse’s orders to keep the resident on his side and out of the wheelchair except for meals should not be implemented or include any explanation for why the interventions were not implemented as part of the resident’s care plan.

A form titled “Comprehensive Admission, Readmission, or New Site Wound Documentation” dated January 27, 2019 but with no time listed, shows that Resident 1 had an unstageable wound 5 by 3.5 (I infer centimeters (cm)) with uneven margins on his

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buttocks.  The form includes the hand-written notation that staff was attempting to keep the area offloaded to the extent the resident permitted.  The form indicates that there was black or brown eschar present in the wound bed.  This form does not indicate where specifically on Resident 1’s buttocks the wound was located.  CMS Ex. 25 at 58, 93.  An observation report dated January 27, 2019 for an observation made that date between 6:16 p.m. and 6:27 p.m., shows that Resident 1 responded only to painful stimuli, his skin was occasionally moist due to incontinence, he was chair fast, his ability to change is body position was very limited, and he had adequate nutrition.  Listed as a problem is that he required moderate to maximum assistance in moving and that needed to be done by completely lifting him to avoid sliding against the sheets, that he frequently slid down in his bed or wheelchair and maximum assistance was required for repositioning him, and his spasticity, contractures, or agitation caused almost constant friction.  A turning and repositioning program was listed as an intervention, but it is not clear from the form that that was a recommendation or intended to indicate such a program was part of Resident 1’s care plan for pressure ulcer prevention and treatment.  The form is marked to indicate that the current plan of care will continue.  CMS Ex. 25 at 95-96

On January 27, 2019, Resident 1’s physician ordered that Resident 1’s wound on his left buttock and ischium be cleaned and dried, a thick layer of zinc ointment was to be applied, and the areas were to be offloaded when possible every shift.  This order may be read to state Resident 1 had a wound on his left buttock and his ischium or a single wound on the left buttock in the flesh over the ischium.  According to Petitioner’s physician order report, Resident 1’s physician issued two orders on January 28, one for the left buttock and ischium and one for the right buttock and ischium, further confusing the number and location of the resident’s pressure ulcers.  However, these orders support a finding that Resident 1’s physician was consulted on January 27, 2019.  New physician orders issued on January 30, 2019, mention only the ischium and left buttock, and do not mention repositioning/offloading or turning the resident at all.  CMS Ex. 25 at 59, 103.  The list of orders does not reflect the time when the orders were issued.  There is no evidence that the physician was informed of the wound nurse’s orders to keep the resident lying on his side and out of his wheelchair except for meals.  There is also no evidence that Resident 1’s IDT discussed the best interventions for the resident, particularly in light of the inconsistency between the wound nurse orders and the physician’s orders.

The evidence includes a message dated January 27, 2019 at 3:10 p.m., in which RN Melissa Weber, Petitioner’s director of nursing (CMS Ex. 24 at 2), requested a “standard air mattress and roho cushion” for Resident 1.  CMS Ex. 25 at 139.  The evidence does not indicate whether either the mattress or cushion were received before Resident 1 went the hospital on February 4, 2019.  Resident 1 was subsequently discharged from Petitioner without returning.

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No new skin abnormalities were noted during skin assessments on January 28 and February 2, 2019.  CMS Ex. 25 at 132-33.  The notation on these forms may be read to mean that there were no new pressure ulcers in addition to those previously assessed.  However, neither form specifically addresses existing pressure ulcers, except that both have the buttocks area circled on the diagram on the form.  A progress note dated January 30, 2019, indicates a nutrition assessment was done and incorrectly noted that the resident’s skin was intact.  CMS Ex. 25 at 106.

However, a nurse’s note dated February 6, 2019, is noted to be a late entry for January 28, 2019.  RN Tarr records that she was called to Resident 1’s room by the CNAs who were preparing the resident for a shower.  The CNAs showed RN Tarr a wound on the resident’s coccyx and intergluteal fold.  RN Tarr described the wound as red and open with no signs or symptoms of infection and no odor.  Her note reflects that she instructed the CNAs to pat the area dry.  She then contacted the wound nurse and requested she reevaluate the dressing as the area was very moist.  The note does not indicate that Resident 1’s physician was notified or consulted.  CMS Ex. 25 at 106, 108.

A physician specializing in wounds evaluated Resident 1 on January 30, 2019.  The specialist identified a wound on Resident 1’s sacrum that was unstageable that was 5 cm by 3.5 cm and the depth could not be determined due to the presence of necrotic tissue.  The specialist performed a surgical excisional debridement of the necrotic tissue to a depth of 0.3 cm.  The specialist’s treatment plan included dressing the wound daily, off-loading the wound, limiting siting to 30 minutes at a time, and repositioning according to facility protocol.  The specialist also identified a wound on the left buttock, which he referred to as a shearing wound rather than a pressure ulcer.  He recommended the application of house barrier cream twice daily for the shearing wound.  CMS Ex. 25 at 129-30.  I find, based on the wound expert’s report, that Resident 1 had two wounds, one a pressure ulcer at the sacrum and the other a shearing wound on the left buttock, with the wound on the sacrum being the most serious.  Based on the expert’s report, I infer that references in Resident 1’s clinic records to wounds over the coccyx or in the intergluteal area refer to the wound identified by the expert as being over the sacrum.  I further infer that references to wounds referred to in the record as on either buttock refer to the wound identified by the wound experts a being on the left buttock.  My findings in this regard are supported by wound management forms created on January 30, 2019, by Petitioner’s wound nurse LPN Renae Renfro (CMS Ex. 24 at 2).  The forms created by LPN Renfro between 10:30 p.m. and 11:00 p.m. on January 30, 2019, state Resident 1 had a pressure ulcer located at his sacrum and ulcer (which the expert reported to be a shearing wound) on his left buttock.  CMS Ex. 25 at 135-38.

A nurse progress note dated February 4, 2019 at 9:01 p.m., indicates Resident 1’s physician was notified that at 8:00 p.m. that Resident 1 had a fever of 101.8 degrees, and that he was given Tylenol but his fever was up to 101.9 degrees an hour later.  The physician ordered that Resident 1 be sent to the emergency room.  Family was present

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with Resident 1 and they were notified of the status change and new order.  Staff determined that Resident 1 had a bowel movement and feces had gotten under his wound dressing.  The wound was cleaned and redressed and Resident 1 was sent to the hospital.  CMS Ex. 25 at 107.  Resident 1 did not return to Petitioner and was discharged from Petitioner on February 4, 2019.  CMS Ex. 25 at 112.

The evidence includes a form with the date February 11, 2019, the title “Advance Directive,” and lists January 31, 2019 as the date recorded.  The form discusses Resident 1’s sacral pressure ulcer, and states that because Resident 1 prefers to be up in his wheelchair, the pressure ulcer was unavoidable.  CMS Ex. 25 at 134.  There is no indication on the form who completed the form or what qualifications the person may have had to render an opinion that a pressure ulcer was unavoidable.  Therefore, the opinion is given no weight.

A form titled “Treatments and Administration History:  01/16/2019 – 02/11/2019, indicates that for each of three shifts on January 16 through 26 and 29 through 31, 2019, staff preformed the order related to the pressure ulcers on Resident 1’s buttock and his coccyx to clean and pat dry, to apply a thick layer of zinc ointment, and to offload every shift when possible.  CMS Ex. 25 at 115 (order refers to right buttock), 122 (order refers to left buttock).  It is not possible for me to determine from this form whether staff actually offloaded the areas by repositioning the resident in his bed or wheelchair or in some other manner, or whether staff concluded it was not possible to do so.

The hospital report dated February 4, 2019, states that on arrival Resident 1 had a “stage IV [full thickness tissue loss with exposed bone] sacral decubitus ulcer” and was complaining of his coccyx aching.  The ulcer measured 6 cm by 3 cm, and 3 cm deep.  CMS Ex. 25 at 20, 26.  A CT scan of the resident showed the ulcer over the coccyx with no bony involvement, and a small left hip effusion.  CMS Ex. 25 at 22.  The left hip effusion was also described as a partial thickness loss on the left buttock with slough noted at the base of the wound.  CMS Ex. 25 at 27.  Resident 2 was treated with intravenous antibiotics for sepsis, a urinary tract infection, and the Stage 3 pressure ulcer over his coccyx.  Resident 2 was subsequently transferred to a hospital in the town where his mother lives.  CMS Ex. 25 at 24-25.

**Analysis**The surveyors allege in the SOD that Petitioner violated 42 C.F.R. § 483.25(b)(1)(i) and (ii) because Petitioner failed to develop a program for offloading Resident 1’s weight on his buttocks while up in his wheelchair and failed to implement a turning and repositioning program, and the failures resulted in Resident 1 developing a pressure ulcer on his sacrum that had to be debrided and led to Resident 1’s hospitalization.  CMS Ex. 2 at 4-5.

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Surveyor Patricia Fountain, RN, wrote the citation of noncompliance under Tag F686 for the survey completed on February 13, 2019.  In her declaration she testified that she cited the noncompliance because Petitioner failed to prevent pressure ulcers from developing in violation of 42 C.F.R. § 483.25(b)(1)(i).  She testified specifically that Petitioner failed to reposition Resident 1 every two hours and regularly offload pressure from his buttocks resulting in a Stage III or IV pressure ulcer.  CMS Ex. 36 at 1-2 ¶¶ 5-9.  She opined that it was inadequate for Petitioner to implement a program to reposition Resident 1 every two hours only during his first day at the facility.  She testified that other measures ordered by Petitioner were complementary to the intervention of repositioning Resident 1 to relieve pressure on his buttocks and the other measures without repositioning were inadequate.  She opined that standards of practice required repositioning in a case such as Resident 1’s.  CMS Ex 36 at 2 ¶ 9.b.ii-iii.  She opined that a Stage III or IV pressure ulcer is actual harm.  CMS Ex. 36 at 4 ¶ 11.

Petitioner is required by the quality of care regulations to ensure that “[a] resident receives care, consistent with professional standards of practice, to prevent pressure ulcers and does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable.”  42 C.F.R. § 483.25(b)(1)(i).  Petitioner is also obliged to ensure that a resident with pressure ulcers receives treatment and services that are consistent with professional standards of practice, that promote healing, prevent infection, and prevent new ulcers.  42 C.F.R. § 483.25(b)(1)(ii).  Surveyor Fountain testified that she cited the noncompliance under this Tag based on violation of 42 C.F.R. § 483.25(b)(1)(i).

CMS has adopted definitions for terms related to the regulation that are to be applied by surveyors in conducting surveys.  A “pressure sore,” often referred to as a “pressure ulcer,” is any lesion of the skin caused by unrelieved pressure, generally over a bony prominence, that damages the underlying tissue.  “Friction” is the mechanical force exerted on skin that is dragged across any surface.  “Shearing” results when layers of the skin rub against each other or the underlying tissue rubs against the skin resulting in tissue damage.  Friction and shearing are not primary causes of pressure ulcers, but they are considered contributing factors.  “Eschar” is thick, leathery, black or brown colored, necrotic or devitalized tissue that has lost its normal physical properties and biological activity, and it may be loose or firmly adhered to a wound.  “Debridement” is the removal of dead tissue and foreign matter from a wound to permit and improve healing.  “Unavoidable” means that the resident developed a pressure ulcer/injury despite the fact a facility evaluated the resident’s clinical condition and risk factors; defined and implemented interventions consistent with resident’s needs, goals, and professional standards of practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate.  CMS identifies four stages for such injuries:  a Stage 1 pressure injury is a non-blanchable redness of the skin; a Stage 2 pressure ulcer is a partial-thickness loss of skin with exposed dermis; a Stage 3 pressure ulcer is a full thickness skin loss with subcutaneous fat visible; and a Stage 4 pressure ulcer is a full-

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thickness skin loss and tissue loss with fascia, muscle, tendon, ligament, cartilage, or bone visible.  SOM app. PP, Tag F686 (rev. 173, eff. Nov. 28, 2017).

Application of the regulation is well-established by the decisions of various appellate panels of the Board.  In *Rae-Ann Geneva Nursing Home*, DAB No. 2461 (2012), the Board reviewed principles recognized in prior decisions of the Board:

The facility must go beyond what seems reasonable and always furnish care and services necessary to prevent new sores, unless clinically avoidable and to treat existing sores;

A prima facie case of noncompliance with the regulation exists when the evidence shows that a resident who is admitted with no pressure sores develops a sore in the facility;

When it is shown that a resident develops a sore in the facility the burden is on the facility to show that development of the sore was clinically unavoidable;

To show that development of a pressure sore was clinically unavoidable, the facility must show it provided all the care and services needed to prevent development of a pressure sore, but a sore developed anyway because it was clinically unavoidable;

Clinically unavoidable means development of the sore was not only unsurprising given the condition of the resident, but it was unpreventable despite appropriate measures implemented considering the clinical risks; and

A facility does not meet its burden to show that a pressure sore or ulcer was clinically unavoidable by a showing that a resident was at increased risk for developing pressure sores.

*Id*., at 6-7. 19

The evidence presented by CMS establishes a prima facie showing of noncompliance based on a violation of 42 C.F.R. § 483.25(b)(1).

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Resident 1 was admitted to Petitioner on January 16, 2019.  CMS Ex. 25 at 112.  Resident 1’s initial care plan completed on January 16, 2019, states that he had a Stage 2 pressure ulcer on an unspecified buttock.  CMS Ex. 25 at 42.  However, an observation report dated January 17, 2019, recorded that Resident 1 had redness on his buttocks and the form was marked to indicate Resident 1 had no pressure ulcers or pressure sores at the time.  CMS Ex. 25 at 50, 99.  A skin assessment on January 24, 2019, documents redness on Resident 1’s buttocks and does not indicate the presence of a pressure sore or ulcer.  CMS Ex. 25 at 56, 131.  An observation report recording a skin – tissue tolerance assessment dated January 25, 2019, indicates that after Resident 1 had been on his back for two hours he had redness on his buttocks over the bony prominence.  However, one hour after the pressure was relieved the redness went away.  CMS Ex. 25 at 57, 94.  The redness observed on Resident 1’s buttocks between January 16 and 25, 2019, as described in the clinical records, does not meet the CMS characterization of a Stage 2 pressure ulcer which involves a partial skin loss.20
  SOM app. PP, Tag F686.  Whether or not the redness may have been a Stage 1 pressure injury as defined by CMS cannot be determined based on Resident 1’s clinical records because the records do not indicate whether the redness was blanchable, i.e., whether the skin turned white when pressed with a finger, a key diagnostic under CMS guidance in the SOM.  Petitioner has not addressed the inconsistency between the diagnosis of a Stage 2 pressure ulcer on an unspecified buttock listed on Resident 1’s initial plan of care and subsequent assessments before January 27, 2019, which show that he had redness on his buttocks.  I find that the

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preponderance of the evidence does not show that Resident 2 had any pressure injury, sore, or ulcer upon admission to Petitioner on January 16, 2019 through the assessment performed on January 25, 2019.

I find no evidence of an assessment of Resident 1’s skin on January 26, 2019.

However, based on the nursing notes, I find that Resident 1 developed a pressure ulcer on about January 26 or 27, 2019.  On January 27, 2019 at about 2:47 p.m. LPN Taylor was informed by the day shift nurse that Resident 1 had a wound on his buttocks.  Where precisely the wound was located is not stated in the resident’s progress note.  There is also no indication how the day shift nurse learned of the wound or when.  The progress note states that LPN Taylor contacted the administrator and the wound nurse.  The wound nurse ordered that thick layers of zinc be applied to the area every shift, the resident was to lie on his sides not his buttocks, and he was to be up only for meals.  CMS Ex. 25 at 108.  A form titled “Comprehensive Admission, Readmission, or New Site Wound Documentation” dated January 27, 2019 but with no time listed, shows that Resident 1 had an unstageable wound 5 by 3.5 with uneven margins on his buttocks.  The form includes the hand-written notation that staff was attempting to keep the area offloaded to the extent the resident permitted.  The form indicates that there was black or brown eschar present in the wound bed.  This form does not indicate where on Resident 1’s buttocks the wound was located.  CMS Ex. 25 at 58, 93.

On January 27, 2019, Resident 1’s physician ordered that Resident 1’s wound on his left buttock and ischium be cleaned and dried, a thick layer of zinc ointment was to be applied, and the areas were to be offloaded when possible every shift.  CMS Ex. 25 at 59, 103.

I conclude that the fact Resident 1 developed a pressure ulcer on about January 26 or 27, 2019, while a resident of Petitioner, is a prima facie showing that Petitioner violated 42 C.F.R. § 483.25(b)(1).  RN Tarr observed the ulcer on January 28, 2019.  RN Tarr described the area as red with open skin.  CMS Ex. 25 at 108.  On January 30, 2019, Resident 1’s pressure ulcer over his sacrum had to be surgically debrided.  CMS Ex. 129-30.  Based on the evidence, I conclude that Resident 1 suffered actual harm based on both the development and necessary treatment for the pressure ulcer over his sacrum.

Therefore, the burden shifts to Petitioner to show that the pressure ulcer over Resident 1’s sacrum was unavoidable.  To show that development of a pressure sore was clinically unavoidable, the facility must show it provided all the care and services needed to prevent development of a pressure sore, but a sore developed anyway because it was clinically unavoidable.  Clinically unavoidable means development of the sore was not only unsurprising given the condition of the resident, but it was unpreventable despite appropriate measures implemented considering the clinical risks.  *Rae-Ann Geneva*, DAB No. 2461 at 6-7.  I conclude Petitioner has failed to meet its burden.

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When Petitioner was admitted on January 16, 2019, an initial plan of care was completed, which required, among other things, that Resident 1 be repositioned every two hours.  CMS Ex. 25 at 42.  As I read the initial plan, the requirement to reposition every two hours was not limited to when the resident was in his bed or his wheelchair.  A comprehensive care plan created on January 21, 2019, included a plan for Resident 1’s risk for pressure ulcers.  CMS Ex. 25 at 11-13, 46-49.  One intervention listed provided for obtaining a special cushion for Resident 1’s wheelchair and a special mattress for his bed.  However, this intervention was not added to the care plan until January 27, 2019, when Resident 1’s pressure ulcer over his sacrum was identified.  CMS Ex. 25 at 11, 46.  The roho cushion and low-air-loss mattress were also not ordered until January 27, 2019.  CMS Ex. 25 at 139.  The January 21, 2019 care plan also provided that Resident 1 be turned and repositioned as he tolerated.  CMS Ex. 25 at 12, 48.  I infer that the requirement to turn and reposition applied whether Resident 1 was in his bed or his wheelchair.  I note that the requirement to turn and reposition as the resident tolerated is significantly different from the requirement of the initial care plan to turn and reposition every two hours.  Petitioner has presented no evidence that the resident’s IDT determined that the change was necessary and appropriate considering the initial assessment of the resident’s risk to develop pressure ulcers verses any potential noncompliance by the resident or psychosocial or other harm to the resident associated with repositioning him every two hours.  Petitioner offers no evidence, and the evidence presented by CMS does not record regular attempts to turn and reposition Resident 1 whether he was in bed or in his wheelchair.  There is also a dearth of evidence showing that Petitioner’s staff regularly implemented many of the interventions listed in the January 21, 2019 care plan.  Petitioner’s failure to show interventions were actually implemented defeat its argument that Resident 1’s sacral pressure sore was unavoidable.

When LPN Taylor was alerted to the fact that Resident 1 had a pressure ulcer on January 27, 2019, she contacted the wound nurse.  In addition to ordering that thick layers of zinc oxide be applied to the area, the wound nurse ordered that the resident be kept on his sides not his back and that he be up in his wheelchair only for meals.  CMs Ex. 25 at 108.  At some unknown time on January 27, 2019, Resident 1’s physician (who was also Petitioner’s medical director) ordered that a thick layer of zinc applied to the area, and the areas were to be offloaded when possible every shift.  CMS Ex. 25 at 59, 103.  The physician orders on January 27 and 28, 2019 mention wounds on Resident 1’s left buttock and ischium and his right buttock and ischium.  There is no mention of a wound over the coccyx or sacrum.  The orders create concern that the physician may not have been fully informed as to the correct location and state of the pressure ulcer identified on January 27, 2019.  There is no evidence the physician was notified of the orders of the wound nurse.  Petitioner presents no evidence that the IDT decided how to resolve the conflict between the wound nurse’s direction to keep the resident on his side and up only for meals and the physician’s order that pressure areas be offloaded, when possible, every shift.  The is also no evidence that the IDT ever addressed Resident 2’s resistance to

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turning and repositioning or minimizing being up in his wheelchair.  Petitioner presents no evidence showing that staff was following any offloading or turning and repositioning protocol for Resident 1.  Petitioner has failed to show that Resident 1’s pressure ulcer over his sacrum developed despite the implementation of a turning and repositioning protocol, whether every two hours or as the resident would tolerate.  The fact that turning and repositioning, i.e., offloading, was a necessary intervention is attested to by the fact that the intervention was included in the initial care plan, the February 21, 2019 care plan, the wound nurse’s order on January 27, 2019, and the physician’s order.  Therefore, Petitioner has failed to show the sacral pressure ulcer was unavoidable.

I conclude that Petitioner has failed to meet it burden to show by a preponderance of the evidence, that Resident 1’s pressure ulcer over his sacrum was unavoidable.

Petitioner does not argue that it corrected the noncompliance cited under Tag F686 based on violation of 42 C.F.R. § 483.25(b)(1), before March 22, 2019, the date CMS determined after additional surveys that Petitioner returned to substantial compliance.  A third survey completed on March 7, 2019, also alleged that Petitioner violated 42 C.F.R. § 483.25(b) in the case of another resident who was placed at risk for more than minimal harm with no actual harm or immediate jeopardy.  CMS Ex. 3.  In fact, Petitioner states in its plan of correction for that allegation of noncompliance that it completed correction of the deficiency on March 22, 2019, the date CMS determined Petitioner returned to substantial compliance.  CMS Ex. 3 at 1.  I conclude that Petitioner did not correct the noncompliance under Tag F686 until March 22, 2019, as determined by CMS.

**Petitioner violated 42 C.F.R § 483.10(g)(14) (Tag F580), and the violation posed a risk for more than minimal harm.****Facts**Findings of fact related to Resident 1’s development of a pressure ulcer over his sacrum are set forth under Conclusions of Law 4 through 6.

Surveyor Fountain testified in her declaration that at approximately 6:30 a.m. on January 27, 2019, a CNA told an RN from the night shift that Resident 1 had a pressure ulcer.  The RN from the night shift told the day shift RN and failed to contact Resident 1’s physician.  The day shift RN also failed to contact Resident 1’s physician but told the LPN coming on duty for the night shift about the resident’s wound.  According to Surveyor Fountain, at approximately 2:45 p.m. on January 27, 2019, eight hours after the CNA first reported the ulcer to the RN at 6:30 a.m., the pressure ulcer was reported to the wound nurse who obtained orders from the resident’s physician.  CMS Ex. 36 at 4-5 ¶ 12.c-e.  I infer that Surveyor Fountain based her testimony on her interviews with the various staff members she refers to in her testimony.  Surveyor Fountain’s notes related to those interviews are found in CMS Ex. 27 at 5-6.  Surveyor Fountain opines that

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Petitioner violated 42 C.F.R. § 483.10(g)(14)(i)(B) because Petitioner’s staff did not immediately consult with Resident 1’s physician.  Petitioner offered no evidence to rebut Surveyor Fountain’s testimony and did not denying in briefing its accuracy.  P. Br., P. Reply.

**Analysis**The surveyors allege in the SOD that Petitioner violated 42 C.F.R § 483.10(g)(14)(i)(B) for failing to immediately notify the physician after discovering that Resident 1 had a new pressure ulcer which was a significant change in his condition and the violation posed a risk for more than minimal harm with no actual harm or immediate jeopardy.  CMS Ex. 2 at 1.

Section 483.10(g)(14)(i) requires that a facility “immediately” consult the resident’s physician when there is “a significant change in the resident’s physical, mental, or psychosocial status.”  42 C.F.R. § 483.10(g)(14)(i)(B).  “Immediately” means “without any intervening interval of time.”  *Magnolia Estates Skilled Care*, DAB No. 2228, at 8-9 (2009); *see also,* 56 Fed. Reg. 48,826, at 48,832-33 (Sep. 26, 1991).  A “significant change” includes “situations when there is a chance that physician intervention is needed.”  *Claiborne-Hughes Health Ctr. v. Sebelius*, 609 F.3d 839, 843 (6th Cir. 2010) (*citing Laurels at Forest Glen*, DAB No. 2182, at 12-13 (2008)).

The language of the regulation is very specific that the facility “consult with the resident’s physician.”  42 C.F.R. § 483.10(g)(14)(i).  It is clear from the language of the regulation that the requirement to consult is not discretionary and requires more than merely informing or notifying the physician.  The use of the term “immediately” in the regulatory requirement indicates that consultation is expected to be done as soon as the change is detected, without any intervening interval of time.  It does not mean that the facility can wait hours or days before consulting with the resident’s physician.  The preamble to the final rule indicates that originally the proposed rule granted the facility up to 24 hours in which to consult with the resident’s physician and to notify the legal representative or family.  However, after the receipt of comments that time is of the essence in such circumstances, the final rule amended that provision to require that the physician be consulted, and the legal representative or family be notified immediately.  56 Fed. Reg. at 48,833.

I have found that on either January 26 or 27, 2019, Resident 1 developed a pressure ulcer over his sacrum.  I conclude that the development of the ulcer was a significant change in Resident 1’s condition within the meaning of 42 C.F.R. § 483.10(g)(14)(i)(B) because it was a deterioration in his health that could be a life-threatening condition and reflected a clinical complication that required physician intervention.  According to the undisputed and unrebutted testimony of Surveyor Fountain, it was roughly eight hours before Petitioner’s staff contacted Resident 1’s physician.  There is no evidence before me recording the contact or showing that an actual consultation occurred.  I further conclude

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that the eight-hour delay in notification of Resident 1’s physician is not the immediate consultation required by the regulations.

Accordingly, I conclude that CMS has made a prima facie showing that Petitioner violated 42 C.F.R. § 483.10(g)(14)(i)(B) (Tag F580) and that the violation posed a risk for more than minimal harm.

**A PICMP of $13,790 for the noncompliance under Tag F689, based on the violation of 42 C.F.R. § 483.25(d)(2), which caused actual harm to Resident 2 is a reasonable enforcement remedy.
	A CMP of $935 per day from February 11 through March 21, 2019, for the noncompliance under Tag F580 based on a violation of 42 C.F.R. § 483.10(g)(14) that posed a risk for more than minimal harm, and the noncompliance under Tag F686 based on a violation of 42 C.F.R. § 483.25(b)(1)(i) that caused actual harm to Resident 1, is a reasonable enforcement remedy.
	Petitioner had not shown that it returned to substantial compliance with program participation requirements before March 22, 2019.**I have concluded that on December 31, 2019, Petitioner violated 42 C.F.R. § 483.25(d)(2) (Tag F689), which caused actual harm to Resident 2.  CMS imposed a PICMP of $13,780 based on the noncompliance cited under Tag F689.  CMS imposed no other enforcement remedy based on the survey that concluded on January 30, 2019.  CMS Ex. 12 at 2.  Therefore, no other citation of deficiency from the survey that ended on January 30, 2019, is at issue before me.

I have concluded that Petitioner violated 42 C.F.R. § 483.10(g)(14) (Tag F580) and the violation posed a risk for more than minimal harm.  I have also concluded that Petitioner violated 42 C.F.R. § 483.25(b)(1)(i) (Tag F686), and that violation caused actual harm to Resident 1.  The noncompliance under Tags F580 and F686 began on about January 26 or 27, 2019, when Resident 1 developed an open pressure ulcer over his sacrum.  The noncompliance continued until March 22, 2019, the date Petitioner stated in its plan of correction for the March 7, 2019 survey that it completed correction of the noncompliance.  CMS Ex. 3 at 1.  CMS imposed a CMP of $935 per day for the period February 11 through March 21, 2019, for the two citations of noncompliance cited by the survey that concluded on February 13, 2019.  CMS Ex. 12 at 2.

The Board has stated that the fact CMPs are included among authorized remedies for noncompliance shows that the Secretary has already determined that CMPs serve a remedial purpose and the Board is bound by that determination.  ALJs and the Board

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review whether a CMP is reasonable under the regulatory factors and can change the amount if they find the CMP is not reasonable based on the factors.  However, ALJs and the Board cannot eliminate the CMP or reduce it to zero under 42 C.F.R. § 488.438(3)(1).  *Liberty Commons Nursing & Rehab. – Alamance,* DAB No. 2070 at 18 (2007), *aff’d, Liberty Commons Nursing v. Leavitt*, 285 F. App’x 37 (4th Cir. 2008).

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

When a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per day CMP for the number of days that the facility is not in compliance or a per instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,525 per day to $21,393 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table) (2019).  The upper range of CMPs is not applicable in this case.  The lower range of CMPs, $107 per day to $6,417 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table) (2019).  CMS is also authorized to impose a PICMP in the range of $2,140 to $21,393, for an instance of noncompliance.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2).

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

In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect,

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indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.

The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.

My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds, considering the purpose of the Act and regulations.  *Liberty Commons Nursing – Alamance,* DAB No. 2070; *Emerald Oaks*, DAB No. 1800 at 10; *CarePlex of Silver Spring*, DAB No. 1683 at 14–16 (1999); *Capitol Hill Cmty. Rehab. & Specialty Care Ctr.*, DAB No. 1629 (1997).

Pursuant to 42 C.F.R. § 488.438(f)(1), I consider Petitioner’s history of noncompliance including any repeated deficiencies.  CMS placed in evidence CMS Ex. 8 which reflects Petitioner’s survey and enforcement history back to March 2005.  I note Petitioner has a history of prior noncompliance related to accidents and pressure ulcers most recently cited by a survey cycle that began September 20, 2018.  CMS Ex. 8 at 1.  No information is provided to me that permits me to compare prior citations of noncompliance with my current findings and conclusions that noncompliance occurred in the surveys at issue before me.  Therefore, the prior noncompliance is noted but is not given weight in determining the reasonableness of the enforcement remedies at issue before me.  Petitioner argues that consideration of prior citations of noncompliance, particularly if not subject to ALJ and Board review, is a violation of Petitioner’s right to due process.  P. Br. at 18.  Petitioner does not specify whether the due process issue is substantive or procedural in nature.  Petitioner cites no authority that 42 C.F.R. § 488.438(f)(1), which permits consideration or prior noncompliance, violates substantive due process.  Petitioner also points to no procedural due process granted by the Act or regulations that has not been accorded to Petitioner in this case.

Petitioner does not argue that it is unable to pay the CMPs imposed in this case.  P. Br. at 17-18; P. Reply at 5-7.  Petitioner has presented no evidence to show that its financial condition warrants a reduction in the imposed CMP.  42 C.F.R. § 488.438(f)(2).

Petitioner argues that it is not culpable.  P. Br. at 17-18; P. Reply at 6.  Pursuant to 42 C.F.R. § 488.438(f)(4), the facility’s culpability is to be considered when determining

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the reasonableness of the CMP.  The regulation provides a non-exhaustive list of what constitutes culpability, including “neglect, indifference, or disregard for resident care, comfort or safety.”  42 C.F.R. § 488.438(f)(4).  Neglect is “failure . . . to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish, or emotional distress.”  42 C.F.R. § 488.301.  I have found and concluded that Residents 1 and 2 both suffered actual harm.  The harm that they suffered was due to failure of Petitioner’s staff to deliver necessary care and services to prevent entrapment of Resident 2’s foot under his wheelchair and to prevent Resident 1 from developing a serious pressure ulcer over his sacrum.  Not only does the noncompliance meet the definition of neglect the evidence shows a disregard for the resident’s care, comfort, and safety.  Accordingly, I conclude that Petitioner was culpable despite its arguments to the contrary.

I also consider under 42 C.F.R. § 488.404(b) the seriousness of the noncompliance in this case.  The noncompliance under Tags F689 and F686 caused actual harm to the two residents involved.  The surveyors and CMS do not allege that either instance of noncompliance posed immediate jeopardy which weighs in favor of Petitioner.  The noncompliance alleged under Tag F580 is related to the noncompliance cited under Tag F686 and posed a risk for more than minimal harm without actual harm or immediate jeopardy.  I also consider that in citing noncompliance the surveyors concluded that the instances of noncompliance were isolated rather than a pattern of noncompliance or widespread noncompliance – conclusions supported by the allegations in the SODs and the evidence.

The PICMP imposed in this case is slightly above the middle of the authorized range of PICMPs.  The per day CMP imposed is well below the middle of the lower range of CMPs authorized.  Based on my review of the regulatory factors, I conclude that the PICMP and CMP imposed in this case are reasonable.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements on December 31, 2018 and from February 11 through March 21, 2019.  I further conclude that the enforcement remedies imposed are reasonable.


          /s/
        Keith W. Sickendick

                      Administrative Law Judge
      1. References are to the 2018 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the surveys, unless otherwise indicated.  In Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), an appellate panel of the Departmental Appeals Board (Board), after reviewing prior Board decisions, expressed a preference for applying the regulations in effect at the time of agency action rather than at the time of the events that were the basis for the agency action, at least in provider and supplier revocation cases.  Other appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the revision of the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted.  Good Shepard Home for the Aged, Inc., DAB No. 2858 at 1 n.1 (2018); Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996). back to note 1
                      2. CMS also filed documents marked CMS Exs. 1 through 35 on November 19, 2019.  However, I rejected those exhibits as they did not conform to requirements of my orders in this case.  Order Rejecting Exhibits, Nov. 21, 2019. back to note 2
                      3. SNFs and 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. back to note 3
                      4. CMS annually adjusts CMP amounts that may be imposed to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016). back to note 4
                      5. Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation similar to those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP. back to note 5
                      6. “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. back to note 6
                      7. This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities.  The “Tag” refers to the specific regulatory provision allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  Ind. Dep’t of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM. back to note 7
                      8. Scope and severity levels are used by CMS and a state when selecting remedies.  Scope and severity levels are designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, ch. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicate a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. back to note 8
                      9. No facts are alleged in the SOD that would constitute a violation of 42 C.F.R. § 483.10(g)(15), which is related only to disclosures at admission to a facility that is a composite distinct part.  CMS Ex. 2 at 1-4. back to note 9
                      10. The surveyors designate both residents as Resident 1 (“R1”) in the two surveys.  However, the allegations show that Resident 1 in the survey that ended February 13, 2019, was male.  CMS Ex. 2 at 8-11.  The allegations in the SOD for the survey completed on March 7, 2019, show that the resident referred to as Resident 1 in that survey was a female.  CMS Ex. 3 at 4. back to note 10
                      11. The SOD cites both 42 C.F.R. § 483.25(d)(1) and (2).  CMS Ex. 1 at 4.  However, Surveyor Staci Byers states in her declaration that the noncompliance cited is based on violation of 42 C.F.R. § 483.25(d)(2).  CMs Ex. 35 ¶ 9. back to note 11
                      12. The SOD also alleges that Petitioner violated 42 C.F.R. § 483.10(b)(15).  CMS Ex. 2 at 1-2.  However, no facts are alleged that constitute a violation of 42 C.F.R. § 483.10(b)(15) and that regulatory requirement is not considered further. back to note 12
                      13. CMS Ex. 14 contains clinical records for Resident 2.  However, CMS Ex. 14 pages 43-44 and 57-58 are records related to a different resident – Resident 1 from the survey completed on February 13, 2019.  The pages that were erroneously included in CMS Ex. 14 are also found among the records of Resident 1 from the February 2019 survey, which are in evidence as CMS Ex. 25. back to note 13
                      14. Petitioner was not cited for a care planning violation and I infer the surveyors simply did not obtain copies of care planning documents related to the leg fracture and wheelchair use.  I also infer the surveyors failed to obtain nursing notes reflecting the incident on December 28, 2018. back to note 14
                      15. I find no other evidence of an investigation of possible neglect or abuse.  Petitioner was not charged by the surveyors with failure to investigate or report possible neglect or abuse.  CMS Ex. 1.  The record contains an Employee Disciplinary Report form that shows that there was further investigation on about January 25, 2019, related to the CNA’s conduct and job performance.  CMS Ex. 15 at 14-17. back to note 15
                      16. Effective November 28, 2016, 42 C.F.R. pt. 483, was extensively revised with many of the participation requirements established by the regulations being moved and renumbered.  81 Fed. Reg. 68,688, 68,697 (Oct. 4, 2016).  Prior to the revision, identical provision related to accident prevention were found at 42 C.F.R. § 483.25(h).  Therefore, many Board decisions refer to 42 C.F.R. § 483.25(h) rather than 42 C.F.R. § 483.25(d). back to note 16
                      17. Petitioner complains that surveyor notes of a surveyor interview of Dr. Kureshey are not in evidence.  P. Reply at 3.  I note Petitioner waived an oral hearing and the opportunity to present the testimony of Dr. Kureshey.  Petitioner also did not submit an affidavit or declaration of Dr. Kureshey to support its defense. back to note 17
                      18. A resident’s comprehensive care plan must be prepared, reviewed, and revised by a resident’s IDT that includes the resident’s physician, a registered nurse responsible for the resident, a nurse aide responsible for the resident, a member of the food and nutrition services staff, the resident and resident’s representative if practicable, and other staff and professionals based on the residents needs or as requested by the resident.  42 C.F.R. § 483.21(b)(2)(ii)-(iii).  In Resident 1’s case, it would be reasonable for a wound care nurse to be a member of the IDT because Resident 1 required such services.  I note that the surveyors did not allege a care planning deficiency in this case. back to note 18
                      19. Board decisions cited discuss the version of the applicable regulation in effect before November 28, 2016, which was at 42 C.F.R. § 483.25(c) and in the SOM under Tag F314.  81 Fed. Reg. 68,688, 68,697. back to note 19
                      20. There are several clinical records for Resident 1 that indicate that Resident 1 had a Stage 2 pressure ulcer at admission and before January 27, 2019, including CMS Ex. 25 at 42, 50, 57, 94, 99, and 112.  However, the actual clinical evidence recording assessments of Resident 1 before January 27, 2019 do not support a finding that Resident 1 had more than redness on his buttocks before January 27, 2019.  I note that the documents appear to have been printed from Petitioner’s electronic records system on either February 11 or 27, 2019, after Petitioner was diagnosed with a pressure ulcer.  I speculate that when the records were printed for the surveyors, Petitioner’s record system automatically updated the diagnoses listed on the forms to include a Stage 2 pressure ulcer based on the development of such an ulcer on about January 26 or 27, 2019.  If my speculation is correct, listing of diagnoses that is not correct for the date of the assessment, care, or treatment reflected by a form, poses a potential risk for Petitioner.  Clinical records must be accurately completed to reflect actual diagnoses and other information at the time the form is completed rather than automatically updated when the form is printed to include content that is not true and correct.  In this case, there is no impact upon the decision in this case as the decision turns on the undisputed development of a pressure ulcer over Resident 1’s sacrum after he was admitted to Petitioner. back to note 20 Back to top
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