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                              Crystal Oaks Long Term Care, DAB CR5302 (2019)
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Crystal Oaks Long Term Care, DAB CR5302 (2019)








  
  
    

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





Crystal Oaks Long Term Care
(CCN: 265369),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-15-2568FDA Docket No. C-15-2568Decision No. CR5302April 25, 2019

        
              
    

      DECISION

Petitioner, Crystal Oaks Long Term Care, was not in substantial compliance with program participation requirements from March 3 through 24, 2015, based on violations of 42 C.F.R. §§ 483.13(b)1
 and (c)(1)(i) (Tag F223) and 483.13(c) (Tag F226). There is a basis for the imposition of enforcement remedies. The following enforcement remedies are reasonable: a denial of payment for new admissions (DPNA) effective March 7 through 24, 2015, and a civil money penalty (CMP) of $5,800 per day from March 3 through 17, 2015, and $150 per day from March 18 through 24, 2015, a total CMP of $88,050.

I. Background

Petitioner is located in Festus, Missouri. Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1. Petitioner participates in Medicare as a skilled nursing facility (SNF). Joint Stipulation of Facts (Jt. Stip.) ¶ 1. Petitioner was subject to a complaint

**Page 2**

investigation by the Missouri Department of Health and Senior Services (state agency) on March 3, 2015, and found not in substantial compliance with program participation requirements.  CMS notified Petitioner by letter dated March 19, 2015, that it was imposing the following enforcement remedies based on the noncompliance found by the state agency during the March 2015, survey:  a CMP of $5,800 per day for the noncompliance cited under Tag F223 and continuing until Petitioner returned to substantial compliance or its participation in Medicare was terminated.  CMS advised Petitioner that the state agency imposed a discretionary DPNA effective March 7, 2015, that would continue until Petitioner returned to substantial compliance or its provider agreement was terminated.  CMS Ex. 1 at 2.  CMS advised Petitioner that its provider agreement and enrollment in Medicare would be terminated on March 26, 2015, if Petitioner did not return to substantial compliance before that date.  Jt. Stip. ¶ 8; CMS Ex. 1 at 1.  Although the CMS notice did not specify the effective date of the CMP, the parties stipulated that it began to accrue on March 3, 2015.  Jt. Stip. ¶ 8; CMS Ex. 2 at 1.

A revisit survey conducted on March 18, 2015, determined that Petitioner abated immediate jeopardy as of March 18, 2015, but that Petitioner had not attained substantial compliance with federal participation requirements.  CMS advised Petitioner by letter dated March 20, 2015, that the CMP of $5,800 ran from March 3 through 17, 2015, and that the CMP was reduced to $150 per day effective March 18, 2015, and would continue to accrue at that rate until Petitioner returned to substantial compliance or its provider agreement was terminated.  CMS advised Petitioner that its provider agreement would not be terminated on March 26, 2015, but that termination would occur if Petitioner did not achieve substantial compliance by September 18, 2015.  CMS also advised Petitioner that the DPNA effective March 7, 2015, would continue until Petitioner returned to substantial compliance or its provider agreement was terminated.  Jt. Stip. ¶  9; CMS Ex. 2.

A second revisit survey conducted on April 1, 2015, determined that Petitioner attained substantial compliance effective March 25, 2015.  CMS advised Petitioner by letter dated April 7, 2015, that the CMP of $5,800 ran from March 3 through 17, 2015, and that the CMP of $150 ran from March 18 through 24, 2015, a total CMP of $88,050.  CMS further advised that the DPNA ended March 25, 2015.  Thus, the DPNA was in effect from March 3 through 24, 2015.  Termination of Petitioner’s provider agreement did not occur due to Petitioner’s return to substantial compliance effective March 25, 2015.  Jt. Stip. ¶  10, CMS Ex. 4.

Petitioner requested a hearing before an administrative law judge (ALJ) on May 4, 2015.  The case was docketed as C-15-2385, assigned to me for hearing and decision, and an Acknowledgment and Prehearing Order was issued at my direction.  Petitioner filed a second request for hearing on May 18, 2015, which was docketed as C-15-2568 and assigned to me for hearing and decision.  On June 9, 2015, the cases were consolidated for hearing and decision under C-15-2568 and C-15-2385 was dismissed.

**Page 3**

A hearing was convened by video teleconference on May 10, 2017.  A transcript (Tr.) of the proceedings was prepared.  CMS offered CMS Exs. 1 through 30.  CMS Exs. 1 through 4, 6 through 19, 21 through 24, and 26 through 30 were admitted.  Tr. at 27-79, 84-88.  Petitioner offered Petitioner exhibits (P. Exs.) A through Z and AA through CC that were admitted as evidence.  Tr. at 76-77.  CMS called the following witness:  Surveyor Angela David, R.N.  Petitioner called the following witnesses:  Heather Cates, Licensed Practical Nurse (LPN); Jean Fink, Registered Nurse (RN), Petitioner’s nightshift supervisor; and James Arnold, Petitioner’s Chief Executive Officer and Administrator.

Following the hearing, CMS offered Exs. 31 and 32.  CMS Ex. 31 is an extract from the State Operations Manual, CMS Pub. 100-07 (SOM), app. PP (rev. 133, eff. Feb. 6, 2015), specifically Tags F223 through F226.  CMS offered the SOM extract per my request at the hearing.  Tr. 172-74, 203-05, 249.  Petitioner does not object to my consideration of CMS Ex. 31; agrees the provisions of the SOM in CMS Ex. 31 were in effect at the time of the survey; and objects to CMS Ex. 32.  Petitioner’s Response to Request for Joint Stipulation and CMS’s Response to Request for Joint Stipulation.  CMS Ex. 31 is admitted as evidence of CMS policy in effect at the time of the March 3, 2015 survey.  CMS Ex. 32 is a list of revisions to SOM app. PP that verifies that CMS Ex. 31 was in effect at the time of the survey.  CMS Ex. 32 is cumulative of Petitioner’s stipulation regarding CMS Ex. 31 and not relevant to an issue I must decide, therefore CMS Ex. 32 is not admitted as evidence.

Petitioner filed its post-hearing brief on August 11, 2017 (P. Br.) and its post-hearing reply brief on September 8, 2017 (P. Reply).  CMS filed its post-hearing brief on August 10, 2017 (CMS Br.) and its post-hearing reply brief on September 11, 2017 (CMS Reply).

Petitioner renewed its hearsay objections to CMS Exs. 6 and 18 in its post-hearing brief.  P. Br. at 9-10; P. Reply at 3-6.  CMS Exs. 6 and 18 are both relevant and authentic and they are admitted as evidence.  However, the hearsay statements in CMS Exs. 6 and 18 are not relied upon for my findings of fact and they are accorded no weight in this decision.

II. Discussion

**A. Issues**

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

Whether the remedy imposed is reasonable.

**Page 4**

**B. Applicable Law**

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.2
 The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of 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 long-term care facility that is not complying substantially with federal participation requirements.  “*Substantial compliance* means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpart B.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if, a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.  State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10-.28, 488.300-.335.  The

**Page 5**

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.

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

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

The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.”  *Life Care Ctr. of Bardstown*, DAB No. 2479 at 33 (2012) (citation omitted).  The allocation of the burden of persuasion and the quantum of evidence required to meet

**Page 6**

the burden is not addressed by regulations.3
  Rather, the Board has long held that the petitioner, the nongovernmental party, bears the burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998); *Hillman Rehab. Ctr.*, DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), *aff’d*, *Hillman Rehab. Ctr. v. United States*, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that only when CMS makes a prima facie showing of noncompliance, is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007).  The Board has not specified how much evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.”  *Id.*; *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904.  “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.”  *Black’s Law*

**Page 7**

*Dictionary*1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, that is, CMS should be burdened to present evidence sufficient to establish a fact as more likely true and to raise a presumption.  However, the Board has never ruled that CMS must establish its prima facie case by a preponderance of the evidence.  Indeed, it is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.  In this case, I conclude that CMS has made it prima facie showing by a preponderance of the evidence.

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

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

CMS alleges, based upon the survey completed on March 3, 2015, that Petitioner was not in substantial compliance with program participation requirements beginning on March 3, 2015, based upon violations of 42 C.F.R. §§ 483.13(b) and 483.13(c)(1)(i) (Tag F223,5

**Page 8**

scope and severity (s/s) J6
) and 483.13(c) (Tag F226, s/s E).  CMS Ex. 6.  A revisit survey completed on March 18, 2015, found that Petitioner abated the immediate jeopardy cited for Tag F223 but that Petitioner failed to return to substantial compliance under both Tags F223 and F226 as cited by the March 3 survey.  Petitioner’s theory is that there was no noncompliance, but, if there was, there was no immediate jeopardy and Petitioner returned to substantial compliance immediately following the incident cited as the basis for the citations of noncompliance.  P. Br.

**1.  Petitioner violated 42 C.F.R. § 483. 13(b) and (c)(1)(i) (Tag F223) and the violation posed a risk for more than minimal harm.**

**2.  Petitioner violated 42 C.F.R. § 483.13(c) (Tag F226) and the violation posed a risk for more than minimal harm.**

Both of the alleged deficiencies in this case relate to an incident involving Resident 1 and the alleged perpetrator, Certified Nursing Assistant (CNA) Robert Leensvaart.  Hence, the deficiencies are discussed together.

The March 3, 2015 Statement of Deficiencies (SOD) alleges that Petitioner violated 42 C.F.R. § 483.13(b) and (c)(1)(i) (Tag F223), because Petitioner failed to protect Resident 1 from abuse.  More specifically the surveyor alleges that:

[T]he facility failed to protect one of three sampled residents from abuse by not immediately removing a female resident from the danger of abuse and not immediately assessing the

**Page 9**

resident when a licensed practical nurse (LPN) walked in on a male certified nursing assistant (CNA) in bed with an elderly contracted (chronic loss of joint motion due to structural changes in non-bony tissue. . .) female resident.  This resulted in the resident being left unattended with the CNA when the LPN left the room to report what he/she saw to a supervisor (Resident #1).

CMS Ex. 6 at 1.  The surveyor does not allege that Resident 1 was actually abused by the CNA.  Surveyor David who conducted the March 3, 2015 survey cited the deficiency as an isolated event that posed immediate jeopardy.  CMS Ex. 6 at 1.  The surveyor alleges as a violation of 42 C.F.R. § 483.13(c) (Tag F226) that Petitioner’s abuse and neglect policy failed to address immediately removing a resident from danger and immediately assessing a resident when abuse is suspected.  The surveyor cited the deficiency as a pattern of noncompliance with potential for more than minimal harm that was not immediate jeopardy.  CMS Ex. 6 at 18-19.  I conclude that Petitioner violated the regulations and the violations posed a risk for more than minimal harm.

**a.  Facts**

The parties stipulated to the following facts:

On February 19, 2015, at approximately 6:00 a.m., LPN Heather Cates (CMS Ex. 12) entered Resident 1’s room and saw CNA Leensvaart (CMS Ex. 12; Tr. 24) on Resident 1’s bed with Resident 1.  CNA Leensvaart got off the bed and LPN Cates went to notify her supervisor.

LPN Cates and her supervisor returned to Resident 1’s room but CNA Leensvaart had departed the room.

The supervisor found CNA Leensvaart and took him to the lobby to wait for Petitioner’s Administrator to arrive.

CNA Leensvaart denied on questioning by the Administrator than there was any inappropriate contact with Resident 1.

The Administrator notified the state agency of the incident at 8:48 a.m.

Jt. Stip. ¶¶ 2-5.  The parties stipulated at hearing that Petitioner contacted both local law enforcement and the state agency.  Tr. 51-52.

LPN Cates was called as a witness by Petitioner.  LPN Cates testified that on February 19, 2015, at about 6:00 a.m. she entered Resident 1’s room and she saw CNA Leensvaart

**Page 10**

jump up from Resident 1’s bed.  She testified she asked him what he was doing and he replied his feet hurt so he was resting them.  LPN Cates testified she assumed he was sleeping because she caught him sleeping at the nurse’s station earlier that night and he had go to his car to sleep during his lunch break.  She testified she left the room to get her supervisor.  She testified CNA Leensvaart was fully dressed and she saw that Resident 1 was wearing something blue, which she assumed was her gown.  She testified she did not know what other clothing Resident 1 may have had on but she did not see any bare skin.  She testified that she did not see CNA Leensvaart touching Resident 1.  She testified that she did not believe that CNA Leensvaart abused Resident 1.  She testified she thought he was one of the better CNAs.  She testified that she got her supervisor, RN Fink, who was on the other side of the building and when they returned to Resident 1’s room RN Fink removed CNA Leensvaart from the area.  She testified she believed CNA Leensvaart posed no risk to Resident 1.  She testified that she told RN Fink that she found CNA Leensvaart in bed with Resident 1.  She testified she saw CNA Leensvaart lying on top of the covers.  She testified that when she and Petitioner’s counsel walked the path she took on February 19, 2015, to get her supervisor and return it took only about three minutes.  She testified she did not assess Resident 1 before leaving the room to get her supervisor.  Tr. 185-91.  LPN Cates identified her prior affidavit admitted as P. Ex. Z and stated it was true and correct.  Tr. 192.  LPN Cates also identified her statement dated February 19, 2015 admitted as CMS Ex. 28, and stated it was correct.  Tr. 193.  In her February 19, 2015 statement, she stated that when she asked CNA Leensvaart what he was doing he responded that he was getting ready to dress Resident 1 but his feet hurt so he gave them a rest.  CMS Ex. 28.  I note that LPN Cates prior statement made near the time of the incident shows that Resident 1 was not dressed yet, but her statement does not reveal what precisely Resident 1 was wearing at the time.  LPN Cates testified that when she left to get her supervisor, CNA Leensvaart was making Resident 1’s bed.  Tr. 194.  She did not clarify if CNA Leensvaart was making Resident 1’s bed while she was in it or if Resident 1 was removed from her bed before LPN Cates left the room.  She testified that if she thought there was any abuse occurring she would have immediately removed CNA Leensvaart.  Tr. 197.  LPN Cates’ testimony is credible with the noted inconsistencies.  I find her statements made closer in time to the incident to be more credible and weighty than her testimony.

RN Fink testified that on February 19, 2015, LPN Cates came to her and reported she found CNA Leensvaart laying in Resident 1’s bed.  She returned to Resident 1’s room with LPN Cates and while walking she called the on-call supervisor to report what was happening.  She located CNA Leensvaart in a neighboring room and removed him to the lobby.  She testified that she also participated with counsel in timing the walk from the resident’s room to where she was when LPN Cates reported to her on February 19, 2015, and the round-trip took only about three minutes.  She testified that she had received no complaints from residents or family about CNA Leensvaart and was unaware of any misconduct but she knew he had a pattern of falling asleep on the job.  She did not think there was any risk to Resident 1.  She testified that after she removed CNA Leensvaart to

**Page 11**

the lobby he never had access to Resident 1 again.  She testified that Resident 1 was assessed by the Assistant Director of Nursing at about 7:30 a.m. on February 19, 2015.  Tr. 207-11, 226-27.

Petitioner’s Chief Executive Officer and Administrator, James Arnold was called as a witnesss.  Administrator Arnold identified his prior written statement dated February 19, 2015 (P. Ex. S), and testified it was accurate.  Tr. 233-34.  He stated in his statement that at about 6:30 a.m. on February 19, 2015, he received a text message from RN Fink that CNA Leensvaart was caught by a nurse lying in a resident’s bed sleeping.  He arrived at the facility at about 7:00 a.m. and he interviewed CNA Leensvaart.  CNA Leensvaart told him his knee hurt so he laid on the bed and fell asleep, jumping-up when LPN Cates entered the room.  CNA Leensvaart told him that the resident had her top on but no pants.  Administrator Arnold reported that incident to both the local police and the state agency consistent with his statement admitted as P. Ex. S.  Administrator Arnold testified that he had no reason to believe CNA Leensvaart acted improperly with any resident.  Tr. 234.  He testified that Petitioner was surveyed in 2013, and it’s policy for preventing and handling complaints of resident abuse, neglect, mistreatment, and misappropriation of resident property had been found deficient.  As a result, Petitioner submitted a plan of correction with a revised policy that was found acceptable by the state agency.  Tr. 235-37; P. Exs. P, Q.  He testified that the policy accepted by the state agency was the policy in effect at the time of the current survey.  Tr. 236-38.  Administrator Arnold testified that the policy does not require that a resident be immediately removed if there is no suspicion of abuse.  Tr. 237.  He testified that in his opinion, LPN Cates acted appropriately by going to get her supervisor when she found CNA Leensvaart in Resident 1’s bed because there was no reason for her to suspect abuse and the time she was absent from Resident 1’s room was very short.  Tr. 238.  He testified that CNA Leensvaart was removed from the facility the morning of February 19, 2015, and thereafter he posed no threat to Resident 1.  Tr. 239.  He agreed on cross-examination that the best way to protect a resident form potential abuse by a staff member is to either remove the resident or the suspected staff member to prevent access to the resident by the staff member.  He testified that he called the police to cover all the bases because he did not know exactly what happened in the resident’s room.  He felt the police would be more skilled in examining CNA Leensvaart.  He testified that he did not suspect any improper conduct but he wanted to be sure.  Tr. 242-43.  Administrator Arnold testified in response to my questions that he informed the state agency representative because he reports “about everything” and he was already on the telephone with a state agency representative discussing another matter.  Tr. 244.  Administrator Arnold’s testimony was credible.

Resident 1 was a 90-year-old female on February 19, 2015, the date of the alleged incident involving CNA Leensvaart.  Resident 1 was examined on February 19, 2015 at about 8:36 a.m., by her physician, A. Patel, MD, who found no abrasions, trauma, or other signs of forced entry of the resident’s vagina.  He noted that a pelvic examination was not possible due to the resident’s age and contractures of her hips.  CMS Ex. 17 at 1.

**Page 12**

A Change of Condition and Progress Note signed by the physician dated February 19, 2015, lists primary diagnoses of advanced or end-stage dementia, hypertension, hyperlipidemia, macular degeneration (right eye only per care plan (CMS Ex. 17 at 52)), and contractures.  She was assessed as:  being nonverbal, with no signs or symptoms of pain; alert only to herself which was status quo; totally dependent for activities of daily living (ADLs); requiring a Hoyer lift for transfers; incontinent of bowel and bladder; and no signs or symptoms of emotional distress.  CMS Ex. 17 at 2-4, 42-46.

Resident 1’s Minimum Data Set (MDS) with an assessment reference date of February 4, 2015, 15 days before the incident, shows:  she could never or rarely make herself understood and she sometime understood others; her mental status and mood could not be assessed due to her inability to understand; she had memory problems; her cognitive skills were severely impaired; she was totally dependent for ADLs; she could not ambulate herself and had difficulty transferring from surface-to-surface with staff assistance; she used a wheelchair; her range of motion of her legs was limited on both sides; she was always incontinent of bowel and bladder; diagnoses included anemia, hypertension, hyperlipidemia, Alzheimer’s Disease, history of cerebrovascular accident, non-Alzheimer’s dementia, and a seizure disorder; she suffered from depression, manic depression, and a psychotic disorder; and she was not noted to be in pain.  CMS Ex. 17 at 12-25.

The parties offered as evidence multiple policies of Petitioner:  titled and dated as follows:

“Abuse – Internal Reporting Requirements and Identification of Allegations,” original issue date September 1999, latest revision March 2015 (CMS Ex. 22; P. Ex. M);7

**Page 13**

“Abuse-Identifying Events; Trend; Patterns; Occurrence of Possible Abuse,” original issue April 2000; latest revision March 2013 (CMS Ex. 21; P. Ex. P at 13-14);

“Resident Abuse and Neglect, Theft, Mistreatment, Protection of Resident,” with issue dates of September 1997, October 1997, and April 2000, and a latest revision dated of March 2015 (CMS Ex. 23);8

“Abuse-Protection of Residents,” original issue September 1999, revised March 2013 (P. Ex. P at 3);

“Adm. Abuse of Residents,” original issue September 1997, revised March 2013 (P. Ex. P at 4-5);

**Page 14**

“Abuse-Theft of Resident Belongings and/or Property,” original issue January 2000, revised March 2013 (P. Ex. P at 6-7);

“Abuse-Internal Reporting Requirements and Identification of Allegations” original issue September 1999, revised March 2013 (P. Ex. P at 8-12);

“Abuse-Identifying Events; Trend; Patterns; Occurrence of Possible Abuse,” original issue April 2000, revised March 2013 (P. Ex. P at 13-14); and

“Abuse, Reporting to Hot Line,” original issue October 1997, revised March 2013 (P. Ex. P at 15-17).

According to Administrator Arnold the policies in evidence with a revision date of March 2013, were revised as part of the plan of correction for a survey in February 2013. Tr. 235-37; P. Exs. P, Q.

Of the policies produced by Petitioner in P. Ex. P, the policy titled “Abuse – Protection Of Residents” which was revised in March 2013, is the most pertinent.  The document states it is the policy of Petitioner “to take immediate steps to protect our residents while any abuse investigation is underway.”  P. Ex. P at 3.  The policy indicates that any employee accused of mistreatment will be suspended immediately.  The policy, which was in effect at the time of the March 3, 2015 survey, does not state what action staff should take to protect a resident upon observing possible abuse, neglect, mistreatment, and misappropriation of resident property, before an investigation is initiated.  The policy provides that a resident who allegedly mistreated another resident will be removed from contact with the allegedly mistreated resident and requires assessment of the alleged abusive resident.  But there is no provision for the immediate removal of an allegedly abusive employee or other provision requiring protection of the allegedly abused resident.  There is no requirement to assess the allegedly abused resident in this policy.  P. Ex. P at 3.

Petitioner’s policy titled “Abuse-Identifying Events; Trend; Patterns; Occurrence of Possible Abuse,” revised March 2013 (P. Ex. P at 13-14) provides it is Petitioner’s policy to aggressively investigate any suspicious event involving a resident including “bruising, fracture, visible signs of unusual mental anguish or other untoward and unusual resident events.”  P. Ex. P at 13.  None of Petitioner’s witnesses suggested in testimony that a staff member lying in bed with a resident is not an usual event.  The policy requires reporting of the event and investigation.  However, the policy does not require that the staff member who discovers an unusual event take immediate steps to protect the resident involved.  The policy requires assessment of the resident to identify any bruising, fracture, or visible signs of unusual mental anguish but does not specify who must do the assessment or how quickly.  P. Ex. P at 13.

**Page 15**

After careful review of the remaining policies Petitioner offered for my consideration in P. Ex. P, I find no instruction to Petitioner’s staff that upon discovery of a situation in which there is possible abuse, neglect, mistreatment, or misappropriation of resident property, the staff member must take immediate action to ensure that the resident involved is protected from further harm.  Examples of staff action to protect a resident may include, but are not limited to, remaining with the resident and calling for help, removing the resident to a secure location if removal will not cause potential harm to the resident, or removing a possible perpetrator.  The policies require resident assessment to determine any physical or mental injury, but they do not specify that the staff member who discovers an unusual resident event conduct an immediate assessment or call for assistance by one qualified to conduct such an assessment to determine if the resident involved requires immediate medical attention to prevent further harm to the resident as a result of the incident.  P. Ex. P at 3-17.

**b.  Analysis**

Section 1819(c)(1)(A)(ii) of the Act requires that a SNF protect its residents and promote their “right to be free from physical or mental abuse, corporal punishment, involuntary seclusion, and any physical or chemical restraints imposed for purposes of discipline or convenience and not required to treat the resident’s medical symptoms.”  The Secretary has provided by regulation that a “resident has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion.”  42 C.F.R. § 483.13(b).  The regulations require that a facility develop and implement written policies and procedures prohibiting mistreatment, neglect, and abuse of residents and the misappropriation of resident’s property.  42 C.F.R. § 483.13(c).  The facility must “[n]ot use verbal, mental, sexual, or physical abuse, corporal punishment or involuntary seclusion.”  42 C.F.R. § 483.13(c)(1)(i).

This case does not turn on whether CNA Leensvaart abused Resident 1.  The issues upon which this case does turn are whether:

LPN Cates failed to take necessary actions to ensure Resident 1 was protected from potential abuse by CNA Leensvaart or harm from any injuries Resident 1 may have suffered after discovering them in the bed together; and

Whether Petitioner had implemented the policies required by 42 C.F.R. § 483.13(c).

**(i.)  The violation of 42 C.F.R. § 483.13(b) and (c)(1)(i) (Tag F223).**

**Page 16**

Surveyor David alleges in the SOD under Tag F223 that Petitioner violated 42 C.F.R. § 483.13(b) and (c)(1)(i) because Petitioner:  (1) failed to protect Resident 1 from abuse because staff did not immediately remove Resident 1 from possible danger of abuse posed by a male staff member; and (2) failed to immediately assess Resident 1 following suspected abuse.  CMS Ex. 6 at 1.   The regulations cited by the surveyor provide:

(b) Abuse. The resident has the right to be free from verbal, sexual, physical, and mental abuse, corporal punishment, and involuntary seclusion.

(c) Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

(1) The facility must—

(i) Not use verbal, mental, sexual, or
physical abuse, corporal punishment,
or involuntary seclusion;

42 C.F.R. § 498.13(b) and (c)(1).  The surveyor did not allege that CNA Leensvaart actually abused Resident 1.  CMS Ex. 6 at 1.  Rather, Surveyor David, made clear in her testimony that the problem was that LPN Cates found CNA Leensvaart in bed with Resident 1, which was “completely unusual,” but LPN Cates failed to take any action to ensure abuse had not occurred or to protect the resident.  Tr. 108-10.

It is not disputed that on February 19, 2015, at about 6:00 a.m., LPN Cates walked into Resident 1’s room and observed CNA Leensvaart in Resident 1’s bed.  LPN Cates thought CNA Leensvaart was merely sleeping on the job and she failed to recognized that abuse or mistreatment of Resident 1 may have occurred or could occur.  It is also not disputed that LPN Cates left CNA Leensvaart in Resident 1’s room alone when she went to report the incident to her supervisor, RN Fink.  By leaving CNA Leensvaart in Resident 1’s room, LPN Cates failed to protect Resident 1 from possible abuse or mistreatment by CNA Leensvaart.  Although I accept Petitioner’s evidence that only about three minutes elapsed from the time LPN Cates left the room and returned with RN Fink, that short period does not ensure that no abuse or mistreatment could occur while CNA Leensvaart remained alone with Resident 1.  Clearly, LPN Cates reported the unusual resident event as required by Petitioner’s policy, but she failed to recognize the potential for abuse, the need to protect Resident 1, and she failed to immediately assess whether Resident 1 suffered any physical or emotional injury that required immediate treatment.  LPN Cates’ failures caused Petitioner to fail to meet its statutory and

**Page 17**

regulatory duties to protect Resident 1 from potential abuse or mistreatment by CNA Leensvaart.

LPN Cates failures may be directly attributable to Petitioner’s failure to develop and implement adequate policies and procedures as required by 42 C.F.R. § 483.13(c) as discussed hereafter.

Petitioner argues that it can only be held liable for violations of 42 C.F.R. § 483.13 if it knows or has reason to know that a potentially abusive act that posed serious harm or injury was likely to occur.  However, Petitioner acknowledges that it is required to act according to 42 C.F.R. § 483.13 and its policies implementing the regulatory requirements, when there is a “suspicion of abuse.”  P. Br. at 10.  Petitioner argues that LPN Cates believed CNA Leensvaart fell asleep in Resident 1’s bed and there was no prior incident that put Petitioner or LPN Cates on notice that CNA Leensvaart might abuse or mistreat a resident.  P. Br. at 11-12.  Petitioner argues that it had no duty to protect Resident 1 in this case because it had no knowledge of any prior abuse incidents involving CNA Leensvaart or his propensity to engage in such acts.  P. Br. at 11-13; P. Reply at 7-10.  Prior knowledge of any prior abusive actions by an employee is not required to trigger Petitioner’s duty to protect its residents from potential abuse, neglect, mistreatment, or misappropriation of resident property.  Petitioner’s duty to protect its residents is triggered by Petitioner’s participation as a provider in Medicare and accepting residents to its facility.  Furthermore, in the case of potential abuse by a staff member, the Board has concluded that foreseeing such potential for abuse is not determinative.

The Board has concluded in prior cases that “[p]rotecting and promoting a resident’s right to be free from abuse necessarily obligates the facility to take reasonable steps to prevent abusive acts, regardless of their source”  *Western Care Mgmt. Corp. d/b/a Rehab Specialties Inn*, DAB No. 1921 at 12 (2004); *Pinehurst Healthcare & Rehab. Ctr.*, DAB No. 2246 at 6 (2009).  Noncompliance with 42 C.F.R. § 483.13(b) and (c)(1)(i) may be found even if no actual resident abuse occurred.  *Honey Grove Nursing Ctr.*, DAB No. 2570 at 3 (2014).  The Board has explained that:

The goal of section 483.13(b) is to keep residents free from abuse. This goal cannot be achieved if a facility could be found in compliance even though it failed to take reasonable steps to protect residents from potentially injurious acts which it knew or should have known might occur and which might be willful. . . .

*Honey Grove Nursing Ctr*., DAB No. 2570 at 3 (citing *Western Care Mgmt. Corp*., DAB No. 1921).  However, the Board has also stated that “considerations of foreseeability are inapposite when staff abuse has occurred” because “a facility acts

**Page 18**

through its staff and cannot disown the consequences of the actions of its employee.”  *Honey Grove Nursing Ctr.*, DAB No. 2570 at 4 (quoting *Gateway Nursing Ctr.*, DAB No. 2283 at 8 (2009)).

I accept as credible LPN Cates testimony that she only thought CNA Leensvaart was sleeping.  However, it is the fact that LPN Cates failed to recognize that the unusual event of a staff member in bed with a resident posed a risk for abuse or mistreatment that is key in this case.  Even if it is true that LPN Cates and members of the management team thought CNA Leensvaart was not likely to abuse or mistreat a resident, that provides no defense for Petitioner.  Lack of knowledge of any prior incidents of abuse or mistreatment by CNA Leensvaart is also not a defense.  LPN Cates should have been trained and knowledgeable enough to recognize that the unusual event of a staff member being in bed with a resident had the potential to involve abuse or mistreatment of that resident and that knowledge and training should have caused her to act immediately to protect the resident and determine whether she required immediate medical intervention.  LPN Cates should have been trained and knowledgeable enough to know that protecting Resident 1 was as simple as remaining in the resident room and calling for help or taking CNA Leensvaart with her to find her supervisor.  LPN Cates should have been trained and knowledgeable enough to know that it was not for her to decide whether abuse had occurred or might occur.  All LPN Cates really needed to know was that CNA Leensvaart was not supposed to be in bed with Resident 1.  Certainly, RN Fink’s actions clearly showed that she recognized and understood the gravity of the situation.  Similarly, Administrator Arnold recognized the gravity of the situation because he promptly called local law enforcement because he did not know for sure what had happened.  Administrator Arnold also immediately advised a member of the state agency after the incident, albeit during a telephone conversation related to another matter.  RN Fink and Administrator Arnold did take immediate action to remove any threat posed by CNA Leensvaart and to assess Resident 1 as Petitioner argues.  P. Reply at 10.  However, LPN Cates’ failures are the cause of the noncompliance.  LPN Cates was Petitioner’s employee and Petitioner failed to protect Resident 1 by ensuring that LPN Cates knew how to respond to the unusual event and then act to protect Resident 1 from potential abuse and ensure that Resident 1 received any necessary medical intervention to prevent harm or continuing harm.9

**Page 19**

Petitioner argues that there is no specific requirement in 42 C.F.R. § 483.13 to immediately assess a resident.  P. Reply at 7.  I agree the regulation does not specifically state a resident must be assessed.  However, Petitioner fails to recognize that inherent in the requirement to protect a resident from abuse, neglect, or mistreatment is the need to conduct an immediate assessment of the resident to determine whether any medical intervention is required to ensure the resident does not suffer continuing harm due to abuse, neglect, or mistreatment.

Accordingly, I conclude that CMS made a prima facie showing that Petitioner violated 42 C.F.R. § 483.13(b) and (c)(1)(i) and the violation posed a risk for more than minimal harm for Resident 1.  Petitioner has failed to meet its burden to rebut the CMS prima facie showing or to establish an affirmative defense by a preponderance of the evidence.10

Petitioner argues that, if I conclude it was not in substantial compliance, I should conclude that the noncompliance lasted no more than one day.  P. Br. at 21-24; P. Reply at 14-15, 17.  However, Petitioner has failed to meet its burden to show by a preponderance of the evidence that it corrected the noncompliance cited under Tags F223 or F226 before March 25, 2015.  In fact, Petitioner states in its revised plan of correction for the March 3, 2015 survey that it completed its plan for correction for both Tags as of March 25, 2015.  P. Ex. J at 4.  The revisit survey on March 18, 2015, determined that Petitioner had not corrected the noncompliance as of the date of the revisit, but Petitioner had abated the immediate jeopardy.  CMS Ex. 7.  These facts make it more likely than not that Petitioner did not return to substantial compliance before March 25, 2015.

**(ii.)  The violation of 42 C.F.R. § 483.13(c) (Tag F226).**

The surveyor alleges a violation of 42 C.F.R. § 483.13(c) (Tag F226) on grounds that Petitioner failed to develop and implement policies and procedures that prohibit

**Page 20**

mistreatment, neglect and abuse of residents.  CMS Ex. 6 at 19.  The surveyor cited this deficiency at a scope and severity of “E,” meaning that there was a pattern of noncompliance that did not result in actual harm, but had the potential for more than minimal harm that is not immediate jeopardy.

The regulation requires in pertinent part:

(c) Staff treatment of residents. The facility must develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents and misappropriation of resident property.

* * * *

(2) The facility must ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source, and misappropriation of resident property are reported immediately to the administrator of the facility and to other officials in accordance with State law through established procedures (including to the State survey and certification agency).

(3) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress.

(4) The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

42 C.F.R. § 483.13(c).

The Board has concluded in cases involving 42 C.F.R. § 483.13(c) and allegations of failure to protect residents from neglect that noncompliance can be based on either failure to develop policies adequate to prevent neglect or to implement the policies.  *Madison County Nursing Home*, DAB No. 2895 at 11 (2018); *Southpark Meadows Nursing & Rehab. Ctr.*, DAB N. 2703 at 6 (2016); *Glenoaks Nursing Ctr*, DAB No. 2522 at 12 (2013).  The Board’s rationale is equally applicable when abuse or mistreatment are involved.  In examining whether a facility has implemented policies and procedures prohibiting abuse, neglect, mistreatment, and misappropriation, the Board has held that

**Page 21**

the issue under 42 C.F.R. § 483.13(c) is “whether the circumstances presented, viewed as a whole, demonstrate a systemic problem in implementing policies and procedures” to prevent abuse.  *Columbus Nursing & Rehab. Ctr.*, DAB No. 2247 at 27 (2009) (citing *Liberty Commons Nursing & Rehab Ctr.–Johnston*, DAB No. 2031 at 14 (2006), *aff’d*,*Liberty Commons Nursing & Rehab Ctr.–Johnston v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007)).

Petitioner’s policy titled “Abuse – Protection Of Residents” states it is the policy of Petitioner “to take immediate steps to protect our residents while any abuse investigation is underway.”  P. Ex. P at 3.  The policy indicates that any employee accused of mistreatment will be suspended immediately.  The policy, which was in effect at the time of the March 3, 2015 survey, does not state what action staff should take to protect  a resident upon observing or receiving an allegation of possible abuse, neglect, mistreatment, and misappropriation of resident property, before an investigation is initiated.  The policy provides that a resident who allegedly mistreated another resident will be removed from contact with the allegedly mistreated resident and requires assessment of the alleged abusive resident.  However, there is no provision for the immediate removal of an allegedly abusive employee or other provision requiring protection of the allegedly abused resident.  There is no requirement to assess the allegedly abused resident in this policy.  P. Ex. P at 3.

Petitioner’s policy titled “Abuse-Identifying Events; Trend; Patterns; Occurrence of Possible Abuse” provides it is Petitioner’s policy to aggressively investigate any suspicious event involving a resident including “bruising, fracture, visible signs of unusual mental anguish or other untoward and unusual resident events.”  P. Ex. P at 13-14.  None of Petitioner’s witnesses suggested in testimony that a staff member lying in bed with a resident is not an usual event.  The policy requires reporting of the event and investigation.  However, the policy does not require that the staff member who discovers an unusual event take immediate steps to protect the resident involved.  The policy requires assessment of the resident to identify any bruising, fracture, or visible signs of unusual mental anguish but does not specify who must do the assessment or how quickly.  P. Ex. P at 13.

After careful review of the remaining policies Petitioner offered for my consideration in P. Ex. P, I find no instruction to Petitioner’s staff that, upon discovery of possible abuse, neglect, mistreatment, or misappropriation of resident property, the staff member must take immediate action to ensure that the resident involved is protected from further harm.  Examples of staff action to protect a resident may include, but are not limited to, remaining with the resident and calling for help, removing the resident to a secure location if removal will not cause potential harm to the resident, or removing a possible perpetrator.  Assessment, though not specifically mentioned in 42 C.F.R. § 483.13(c), is obviously necessary both to determine whether the resident requires immediate medical intervention and as the first step in the investigation required by the regulation.  The need

**Page 22**

for protection from further harm and assessment of the resident should be recognized and understood by trained nursing staff and by all other staff.  LPN Cates demonstrated that the facility policy must be specific and training on the policy is required to ensure staff recognizes possible abuse, neglect, mistreatment, or misappropriation of property.

Petitioner’s policies specifically require resident assessment to determine any physical or mental injury.  However, Petitioner’s policies do not specify that the staff member who discovers an unusual resident event conduct an immediate assessment or call for assistance by one qualified to conduct such an assessment to determine if the resident involved requires immediate medical attention to prevent further harm to the resident.  P. Ex. P at 3-17.  One may hope that it is unnecessary to write clearly such a requirement in a policy on the basis such actions should be second nature to trained staff.  However, this case clearly shows the need for clarity in policies and constant training to recognize possible abuse and to take appropriate action to ensure the safety and welfare of the residents involved.

The facts in this case are that LPN Cates failed to recognize that the unusual event of CNA Leensvaart being in bed with Resident 1 was possibly an incident of abuse or mistreatment.  LPN Cates left CNA Leensvaart alone in the room with Resident 1 for up to three minutes.  LPN Cates did not assess Resident 1 to determine if she had obvious signs of any abuse or mistreatment and could not even testify with certainty what Resident 1 was wearing at the time.  The overarching requirement of 42 C.F.R. § 483.13(c) is to protect the resident from abuse and harm related thereto.  LPN Cates failed to understand the incident she observed had the potential for abuse or mistreatment of a resident and she failed to protect that resident.  Based on my review of Petitioner’s policies in effect at the time, they were not sufficiently clear to train staff to identify possible abusive situations and the actions required to protect a resident immediately from further abuse or to protect a resident from further harm if abuse or mistreatment occurred.  Even if one concluded that Petitioner’s policies were sufficiently clear, LPN Cates clearly showed that the policies were not implemented to ensure Resident 1 was protected.

Accordingly, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.13(c) and Petitioner has failed to rebut the prima facie showing or establish an affirmative defense.

Petitioner argues that 42 C.F.R. § 483.13(c) does not require that the policy and procedures required by that regulation specify that residents must be immediately removed from danger and immediately assessed.  P. Br. at 19-20; P. Reply at 12-13.  Petitioner is correct, the regulation does not specify the text for Petitioner’s policies or exactly what must be included.  The regulation clearly does require that Petitioner “must prevent further potential abuse while the investigation is in progress.”  42 C.F.R. § 483.13(c)(3).  The plain language of this provision requires protection of the resident

**Page 23**

who is the target of abuse as well as all other residents from potential abuse.  It would be a ridiculous interpretation of this regulatory requirement to conclude that it applies only upon initiation of the investigation and not immediately upon the allegation or discovery of abuse, neglect, or mistreatment of a resident.  The regulation, 42 C.F.R. § 483.13(c), also requires that Petitioner thoroughly investigate and retain documents reflecting the investigation.  A necessary step in such an investigation, often before it is formally convened, is the immediate initial assessment to determine whether there is evidence of what occurred.  The immediate initial assessment is also necessary to determine whether a resident needs immediate medical intervention to prevent further harm, physical or mental, which is clearly required by other regulatory requirements that establish Petitioner’s duty of care for its residents.  *See e.g.*, 42 C.F.R. §§ 483.20, 483.25, 483.30, 483.40.  I agree with Petitioner that regulations should be as clear and comprehensive as possible, but in this case the regulatory scheme is clear enough to put Petitioner on notice of its duties to protect and care for its residents.

Petitioner also argues that the policies in effect in February 2015 were the policies reviewed and approved by the state agency and CMS during the March 2013 survey.  P. Br. at 11-12, 20; P. Reply at 12; P. Exs. P, Q.  Petitioner cites no authority for the proposition that CMS is bound by its prior determination related to Petitioner’s policies in 2013.  Based on my review, Petitioner’s policies were deficient in 2013 when approved by the state agency and CMS, and their deficiency was clearly shown in this case.  Past action of the state agency and CMS notwithstanding, I am required to follow the Act and regulations.  *1866ICPayday.com*,*L.L.C.*, DAB No. 2289 at 14 (“[a]n ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground.”)  Petitioner’s argument could be construed to be that CMS should be estopped from enforcing 42 C.F.R. § 483.13(c) against Petitioner based on the prior approval of Petitioner’s deficient policies.  However, estoppel against the federal government, if available at all, is presumably unavailable absent “affirmative misconduct,” such as fraud.  *See, e.g.*,*Pacific Islander Council of Leaders*, DAB No. 2091 at 12 (2007); *Office of Pers. Mgmt. v. Richmond*, 496 U.S. 414, 421 (1990).  Petitioner alleges no affirmative misconduct or fraud by the state agency or CMS and I find none based on the evidence before me.

**3.  The declaration of immediate jeopardy related to the noncompliance with 42 C.F.R. § 483.13(b) and (c)(1)(i) (Tag F223) was not clearly erroneous.**

CMS alleges that the noncompliance based on the violation of 42 C.F.R. § 483.13(b) and (c)(1)(i) (Tag F223) posed immediate jeopardy to Petitioner’s residents beginning on March 3, 2015 and continuing through March 17, 2015.  CMS Exs. 2, 4, 6.  Petitioner asserts that there was no immediate jeopardy but, if I should find there was immediate jeopardy, it was abated by February 19, 2015.  P. Br. at 21-22; P. Reply at 13-14.  Petitioner encourages me to consider the fact that the surveyor did not recognize that

**Page 24**

there was immediate jeopardy on February 19, 2015, when she entered the facility to conduct the complaint investigation and she left that day without requiring any action by Petitioner.  Tr. 126-32; P. Br. at 6, 14-15; P. Reply at 14.  Surveyor David testified that the decision to declare immediate jeopardy was not hers as that decision was made later by CMS.  Tr. 132.  Surveyor David agreed on cross-examination that when she identifies immediate jeopardy, she is not supposed to leave the facility until the immediate jeopardy is abated.  She also agreed that because CNA Leensvaart was arrested and Resident 1 was assessed twice on February 19, 2015, she left the facility thinking that there was no immediate jeopardy for Resident 1. Tr. 133.

The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  *Yakima Valley Sch.,* DAB No. 2422 at 8-9 (2011); *Cal Turner Extended Care Pavilion*, DAB No. 2384 at 14 (2011); *Brian Ctr. Health & Rehab./Goldsboro,*DAB No. 2336 at 9 (2010) (*citing* *Barbourville Nursing Home*, DAB No. 1962 at 11 (2005), *aff’d, Barbourville Nursing Home v. U.S. Dep’t of Health & Human Srvs.,*174 F. App’x 932 (6th Cir. 2006); *Maysville Nursing & Rehab. Facility*, DAB No. 2317 at 11 (2010); *Liberty Commons Nursing & Rehab. Ctr.– Johnston*, DAB No. 2031 at 18-19 (2006), *aff’d, Liberty Commons Nursing & Rehab. Ctr.–Johnson v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007).  Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous.  *Cal Turner Extended Care Pavilion*, DAB No. 2384 at 14-15; *Liberty Commons Nursing & Rehab. Ctr.–Johnston*, 241 F. App’x 76 at 3-4.

“*Immediate jeopardy”* under the regulations refers to a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. §§ 488.301, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility’s residents is not an initial determination that

**Page 25**

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

Many appellate panels of the Board have addressed “immediate jeopardy.”11
****In ***Mississippi Care Ctr. of Greenville*,**DAB No. 2450 at 15 (2012), the Board commented**:**

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

****Page 26****

matter of professional judgment and expertise, is entitled to deference.” *Daughters of Miriam Center*, DAB No. 2067, at 15 (2007).

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

We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility's obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  **For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA [now known as CMS] findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.**

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59 Fed. Reg. at 56,179 (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decision in *Mississippi Care Ctr. of Greenville*; *Daughters of Miriam Ctr.,* and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation; would significantly limit the review of the determination by an ALJ and the Board; and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from *Mississippi Care Ctr. of Greenville,*that panel of the Board states that the clearly erroneous standard means that the “immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.”  *Id*. at 14.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.”  However, the Board’s characterization of the “clearly erroneous standard” in *Mississippi Care Ctr.* and other cases does not define the standard.  The “clearly-erroneous standard” is described in Black’s Law Dictionary as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  *Black’s Law Dictionary* 269 (8th ed. 2004).  The Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  *In re Winship*, 397 U.S. 358, 371-72 (1970); *Concrete Pipe and Products of California, Inc. v. Construction Laborers*, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  *Consolidated Edison*, 305 U.S. 197, 229 (1938); *Dickinson v. Zurko*, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  *United States v. United States Gypsum Co.*, 333 U.S. 364, 395 (1948); *Dickinson*, 527 U.S. at 162; *Concrete Pipe*, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also

****Page 28****

****commented that the APA requires meaningful review.12
 *Dickinson*, 527 U.S. at 162 (citations omitted); *Concrete Pipe*, 508 U.S. at 622-23.

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

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm?”  On the first question, the Board recognized in *Yakima Valley Sch.*, DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.13
  The

****Page 29****

****Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.”  *Id.*, *citing Daughters of Miriam Ctr.*, DAB No. 2067 at 9.  In *Daughters of Miriam Ctr*, the Board discussed that the ALJ attempted to define “serious” finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heal without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  *Daughters of Miriam Ctr.,*DAB No. 2067 at 9.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found based on the violations of 42 C.F.R. § 483.13(b) and (c)(1)(i), I have no definite and firm conviction that an error has been committed in CMS’s determination that immediate jeopardy existed or its duration.  LPN Cates failed to recognize an incident of potential abuse or mistreatment leaving Resident 1 alone with CNA Leensvaart while LPN Cates left the room to find help.  LPN Cates also left the room without determining whether Resident 1 was okay, as reflected by the fact that LPN Cates could not attest to what Resident 1 was actually wearing.  Petitioner’s argument that LPN Cates complied with the requirements of its policies that were approved by the state agency and CMS in 2013 does not show that the declaration of immediate jeopardy was clearly erroneous.  In fact, LPN Cates actions clearly show that Petitioner’s policies were defective exposing the resident to potential abuse, even though for only a brief period.  Failure to ensure that the perpetrator of an alleged or suspected act of abuse is removed or isolated from residents to protect residents from further acts of abuse as required by 42 C.F.R. § 483.13(b), poses a risk that a resident may suffer serious injury, harm, impairment, or death.  Petitioner’s evidence does not show that there was no

****Page 30****

likelihood for serious (given any accepted definition of that term) injury, harm, impairment or death on account of the noncompliance.  *Yakima Valley Sch.*, DAB No. 2422 at 8.  Accordingly, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy based on the violation of 42 C.F.R. § 483.13(b) and (c)(1)(i) was clearly erroneous.

**4.  A CMP of $5,800 per day from March 3 through 17, 2015 and $150 per day from March 18 through 24, 2015, a total CMP of $88,050 and a DPNA effective March 3 through 24, 2015, are reasonable enforcement remedies.**

I have concluded that Petitioner violated 42 C.F.R. §§ 483.13(b) and 483.13(c)(1)(i) (Tag F223) and 483.13(c) (Tag F226) from March 3 through 24, 2015 .  I have also concluded that the declaration of immediate jeopardy related to the violation of 42 C.F.R. § 483.13(b) and (c)(1)(i) from March 3 through 17, 2018, was not clearly erroneous.  Therefore, CMS has bases to impose enforcement remedies.

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.  The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.

My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within

****Page 31****

reasonable bounds considering the purpose of the Act and regulations.  *Emerald Oaks*, DAB No. 1800 at 10 (2001); *CarePlex of Silver Spring*, DAB No. 1683 at 14-16 (1999); *Capitol Hill Cmty. Rehab. & Specialty Care Ctr.*, DAB No. 1629 (1997).

There is no dispute that Petitioner has a history of noncompliance under Tag F226.  An abbreviated survey and complaint investigation by the state agency completed on February 7, 2013, determined Petitioner was noncompliant under Tag F226.  Petitioner revised it policies required by 42 C.F.R. § 483.13(c) as a result.  Tr. 235-37; P. Exs. P, Q.

Administrator Arnold testified that Petitioner is an independent, not-for-profit.  He testified that there is no profit to a corporation or individual and a CMP will cut deeply into Petitioner’s cash reserves, limiting Petitioner’s ability to repair equipment and buy new equipment.  Tr. 241.  On cross-examination he agreed that Petitioner had never requested that CMS consider the potential hardship.  Tr. 242.  Petitioner has not provided me with financial statements or other evidence in support of Administrator Arnold’s testimony.  I accept his testimony as fully credible, but I have no idea based on his testimony alone, how significant the impact of a CMP will be upon Petitioner’s reserves and ability to maintain its operations.

Petitioner’s noncompliance under both Tags F223 and F226 is serious.  Petitioner has not shown that the immediate jeopardy related to the violation of Tag F223 was clearly erroneous or abated prior to March 17, 2015.  LPN Cates failure to take action to immediately protect Resident 1 from further abuse and to ensure she suffered no harm from any abuse that may have already occurred is extremely serious.  Petitioner’s evidence clearly shows that CNA Leensvaart later confessed to police his abuse of Resident 1, confirming the seriousness of LPN Cates failure to act immediately.  P. Ex. BB at 2-3.  This is not an example of hindsight rather it is a clear example of a lack of awareness and foresight.  Properly trained staff based on properly developed and implemented policies must be able to recognize circumstances that could result in resident abuse, neglect, mistreatment, or misappropriation of their property.  Policies and training must be sufficient to cause staff to recognize the risk and to respond appropriately.  There is no dispute that LPN Cates recognized it was highly unusual and not permitted for a staff member to lie in bed with a resident but LPN Cates’s concern was malingering not abuse.  I conclude that Petitioner was culpable because Petitioner failed to ensure Resident 1 was protected from potential abuse or mistreatment by staff.  I also conclude that Petitioner was culpable for not developing and implementing effective policies and procedures as required by 42 C.F.R. § 483.13(c).  I do conclude that Petitioner is less culpable based on the fact the state agency and CMS approved Petitioner’s plan of correction and revised policies in March 2013.  P. Exs. O, Q.  I also consider Petitioner less culpable because RN Fink and Administrator Arnold did act appropriately, by ensuring CNA Leenvaart was quickly removed from resident contact, the local police were contacted and began a prompt investigation, and Petitioner immediately self-reported the incident to the state agency.****

****Page 32****

****A CMP that is imposed against a facility on a per day basis falls into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $3,050 per day to $10,000 per day, is reserved for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  The lower range of a CMP, $50 per day to $3,000 per day is reserved for deficiencies that do not constitute immediate jeopardy but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  The CMP of $5,800 per day from March 3 through 17, 2015, the period of immediate jeopardy, is in the low end of the range of CMPs authorized for immediate jeopardy.  The CMP of $150 per day from March 18 through 24, 2015, was abated is also in the low end of the authorized range.  In light of the relevant factors, I conclude that the amount and duration of the CMP are reasonable.  I also conclude that CMS was authorized to impose a discretionary DPNA during the period March 7 through March 24, 2015, and that the DPNA is a reasonable enforcement remedy.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from March 3 through 24, 2015.  I also conclude that a CMP of $5,800 per day from March 3 through 17, 2015, and $150 per day from March 18 through 24, 2015, a total CMP of $88,050, and a DPNA from March 7 through 24, 2015, are reasonable enforcement remedies.


          /s/
        Keith W. Sickendick

                      Administrative Law Judge
      1. References are to the 2014 revision of the Code of Federal Regulations (C.F.R.), unless otherwise indicated. back to note 1
                      2. Participation of a nursing facility (NF) in Medicaid is governed by section 1919 of the Act. Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act. back to note 2
                      3. Congress granted the Secretary authority to impose enforcement remedies for noncompliance. Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)). The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act (42 U.S.C. § 1320a-7a). CMPs are imposed by CMS with delegated authority of the Secretary. 42 C.F.R. § 488.2. Pursuant to subsection 1128A(j) of the Act, section 205 of the Act (42 U.S.C. § 405) is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act. The Inspectors General (IGs) for both HHS and the Social Security Administration 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 3
                      4. “Credible evidence” is evidence that is worthy of belief. Black’s Law Dictionary 596 (18th ed. 2004). The “weight of evidence” is the persuasiveness of some evidence compared to other evidence. Id. at 1625. back to note 4
                      5. This is a “Tag” designation as used in SOM app. PP – Guidance to Surveyors for Long Term Care Facilities (http://www.cms.hhs.gov/Manuals/IOM/list.asp). The “Tag” refers to the specific regulatory provision allegedly violated and CMS’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 5
                      6. Scope and severity levels are used by CMS and a state when selecting remedies. The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, Chap. 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 indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety. The 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 6
                      7. The March 2015 revision of this policy was in response to the findings of noncompliance from the March 3, 2015 survey and revisit. P. Reply at 6; CMS Ex. 22; P. Ex. M. It is not obvious from the face of this document how it was changed. However, it may be inferred that requirements to immediately remove a resident from the threat of danger and immediately assess a resident who was a potential victim of abuse were added by Petitioner.
I do not consider the fact that Petitioner made changes to its policy an admission by Petitioner that it was in violation of 42 C.F.R. § 483.13(c). I agree with Petitioner (P. Reply at 6) that it is inappropriate to consider subsequent remedial measures adversely to Petitioner in this case. I find unpersuasive and not binding prior Board decisions rejecting the notion that subsequent remedial measures should not be considered an admission of a regulatory violation. See e.g. Rockcastle Health and Rehab. Ctr., DAB No. 2891 at 15 (2018). I agree with the Board that Fed. R. Evid. 407 is not binding in this forum and that the law related to torts is also not binding. However, the policy reasons for not treating subsequent remedial measures adversely to a Petitioner in cases such as this must be considered in the absence of any statutory or regulatory guidance. First, it is clear that Petitioner had no choice in this case but to change its policy or continue to be held noncompliant with a continuing CMP. Petitioner did not change its policies because it admitted it was wrong, it changed it policies because it was compelled to by the authority of CMS and the state agency, which is the purpose for imposing enforcement remedies. 42 C.F.R. §§ 488.400, 488.402(a). Second, treating subsequent remedial measures as an admission of a regulatory violation, clearly can deter a facility from changing policies based on an identified defect, whether that defect is identified by a survey or not. Deterring facilities from improving compliance with statutory and regulatory compliance is clearly contrary to the purpose of the Act and regulations to improve long-term care of Medicare recipients and protection of the Medicare Trust Fund. Petitioner placed the March 2013 revision of this policy in evidence as P. Ex. P at 8-12, so it is not necessary for me to attempt to discern from CMS Ex. 22 and P. Ex. M what the policy said before it was changed in response to the March 2015 survey and revisit. back to note 7
                      8. Based on the revision date of this document, it is likely that it was revised due to the March 3, 2015 survey and revisit. I have no copy of a prior version of this document in evidence to determine how it was modified and make no attempt to do so. I do not consider any changes as an admission by Petitioner of a violation of 42 C.F.R. § 483.13(c). back to note 8
                      9. Petitioner implies that there was no visible or apparent injury of Resident 1. P. Reply at 10. However, the implication is not supported by the facts. LPN Cates’ failure to conduct even a rudimentary assessment of Resident 1 is shown by the fact that she was not certain as to what Resident 1 was wearing at the time other than a blue garment that may or may not have been a gown. Tr. 185-91. back to note 9
                      10. Petitioner explains that it requested informal dispute resolution (IDR) as authorized by 42 C.F.R. § 488.431(a). P. Ex. AA. The IDR was favorable to Petitioner. P. Ex. BB; P. Reply at 8-9. Petitioner does not explain how I should weigh this evidence. However, CMS clearly did not accept the IDR results in this case and those results are not binding upon CMS or me. 42 C.F.R. § 488.431(a). I have weighed the IDR results as evidence offered by Petitioner, but I find those results do not, in the face of all the evidence of record, support a conclusion that it is more likely than not no noncompliance occurred. back to note 10
                      11. Decisions often cited include: Lakeport Skilled Nursing Ctr., DAB No. 2435 at 6 (2012); Liberty Health & Rehab. of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Daughters of Miriam Ctr., DAB No. 2067; Britthaven of Havelock, DAB No. 2078 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726. back to note 11
                      12. The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttal presumption, is entirely consistent with the Supreme Court’s characterization of the standard. However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue. back to note 12
                      13. The version of Appendix Q of the SOM in effect at the time of this survey also failed to provide surveyors a working definition of the term “serious” that they could use to determine whether harm, injury, or impairment was serious when deciding whether or not to declare immediate jeopardy. The Act does not define the phrase “immediately jeopardize” and does not introduce the concept of serious harm, injury, or impairment as the basis for finding immediate jeopardy. Thus, one is not in error concluding that absent a definition of the term “serious” in the Act, the regulations, the SOM, or decisions of the Board, it is essentially up to individual surveyors, and whatever unpublished guidance they receive from their superiors or CMS officials, to exercise their individual discretion and judgment to decide that there was immediate jeopardy, which subjects a facility to the maximum imposable CMPs. back to note 13 Back to top
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