Kennybrook Village, DAB CR5863 (2021)

DECISION

Following a survey by the Iowa Department of Inspections and Appeals (state agency), the Centers for Medicare & Medicaid Services (CMS) concluded that Kennybrook Village (Petitioner or facility) was not in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.10(c)(6), (c)(8), (g)(12), and 483.24(a)(3) (right to refuse treatment and to formulate advance directives), and 42 C.F.R. § 483.25(d)(1), (2), (n)(1)-(3) (right to be free of accident hazards and to receive supervision and assistive devices).1  CMS determined that Petitioner's past noncompliance constituted immediate jeopardy to resident health and safety and imposed a civil money penalty (CMP) of $14,541 per day for two days from April 5, 2017, through April 6, 2017.  Thereafter, CMS found that Petitioner abated the immediate jeopardy, but that Petitioner's continued noncompliance constituted isolated actual harm that was not immediate jeopardy.  Based on the non-immediate jeopardy level noncompliance, CMS imposed a CMP of $503 per day for 20 days from April 7, 2017 through April 26, 2017.  In all, CMS imposed CMPs of $39,142 for the deficiencies cited.  Petitioner requested a hearing to challenge CMS's findings and the remedies imposed.

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For the reasons explained in this decision, I conclude that Petitioner was in substantial compliance with the Medicare participation requirements under 42 C.F.R. §§ 483.10(c)(6), (c)(8), (g)(12), and 483.24(a)(3).  Because Petitioner complied with these regulations, the finding of immediate jeopardy is without factual support and there is no basis to impose a CMP of $14,541 per day for April 5, 2017, through April 6, 2017.  However, I conclude that Petitioner failed to comply substantially with the Medicare participation requirements established by 42 C.F.R. § 483.25(d)(1), (2).  Thus, there is a basis to impose a CMP for that noncompliance.  Finally, I conclude that a CMP of $503 per day from April 5, 2017, through April 26, 2017 is reasonable.

I.  Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Grimes, Iowa.  CMS Exhibit (Ex.) 6 at 1.  On March 31, 2017, Petitioner self-reported to the state agency that Resident #1 2 had experienced an "accident with major injury." CMS Ex. 26 at 1.  The state agency "triaged [the accident] as nonIJ [non-Immediate Jeopardy] high due to inadequate nursing supervision."  Id.  In an addendum dated April 6, 2017, Petitioner's Administrator reported that Resident #1 had died on April 5, 2017, after returning to the facility from the hospital.  Id. at 2.

Based on the self-report, the state agency scheduled an onsite survey to begin on April 10, 2017.  Id.  State agency surveyor Pamela Diveney (Surveyor Diveney) was assigned to conduct the survey, which was completed on April 26, 2017.  Id.; see also P. Ex. 3 at 1 (original Form CMS-2567); CMS Ex. 6 at 1 (amended Form CMS-2567).3   Based on the survey findings, CMS determined that the facility was not in substantial compliance with the following requirements:

• 42 C.F.R. §§ 483.10(c)(6), (c)(8), (g)(12), and 483.24(a)(3) (Tag F155 ‑ Right to Refuse; Formulate Advanced Directives) at scope and severity level K (pattern of noncompliance that poses immediate jeopardy to resident health and safety); and

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• 42 C.F.R. §§ 483.25(d)(1), (d)(2), (n)(1)-(3) (Tag F323 - Free of Accident Hazards/Supervision/Devices) at scope and severity level G (isolated noncompliance that causes actual harm that is not immediate jeopardy).4

CMS Ex. 1 at 1; see also CMS Ex. 6.

In a letter dated May 18, 2017, CMS informed Petitioner that, based on the state agency's survey findings, CMS determined that the facility was not in substantial compliance with Medicare participation requirements.  CMS Ex. 1 at 1.  CMS further informed Petitioner that it was imposing a per‑day CMP of $14,541 for two days of past noncompliance (April 5, 2017, through April 6, 2017) and a per-day CMP of $503 beginning April 7, 2017, and continuing each day until the facility returned to substantial compliance.  Id.  By letter dated August 9, 2017, CMS notified Petitioner that, based on a May 24, 2017 revisit, the state agency determined that the facility returned to substantial compliance with Medicare participation requirements effective April 27, 2017.  CMS Ex. 2 at 1.  Thus, CMS assessed a $14,541 per-day CMP for Petitioner's noncompliance at the immediate jeopardy level for two days (April 5, 2017 through April 6, 2017) totaling $29,082 and a $503 per-day CMP for Petitioner's noncompliance at the non‑immediate jeopardy level for 20 days (April 7, 2017 through April 26, 2017) totaling $10,060.  Id. In all, CMS imposed a total CMP amount of $39,142.  Id.

Petitioner timely requested a hearing, and the case was assigned to me.  I issued an Acknowledgment and Prehearing Order establishing a briefing schedule.  In accordance with the schedule, CMS and Petitioner filed prehearing exchanges, including prehearing briefs (CMS Br. and P. Br., respectively), exhibit and witness lists, and proposed exhibits.  As part of its prehearing exchange, CMS offered the written direct testimony of one witness.  CMS Ex. 33.  Petitioner offered the written direct testimony of six witnesses.  P. Exs. 13-18.  Petitioner requested to cross‑examine CMS's witness.  P. Br. at 25.  CMS did not request to cross-examine Petitioner's witnesses in its prehearing exchange.

On October 16, 2018, I conducted a telephone prehearing conference with the parties, the substance of which is described in a Summary of Prehearing Conference and Notice of Hearing issued October 18, 2018 (Summary).  Docket Entry #16 in the Departmental Appeals Board (DAB) Electronic Filing System (E-File).  In the Summary, I noted that, at the prehearing conference, CMS untimely requested cross-examination of Petitioner's witnesses, that Petitioner objected to the request as untimely, and that, in the interest of making a complete administrative record, I exercised my discretion to permit CMS to

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cross-examine Petitioner's witnesses Wilda Thomas, LPN (LPN Thomas), Joni Frantz, RN (RN Frantz), and Assistant Director of Nursing Carrie Reiling, RN (ADON Reiling).5   I also directed CMS to produce Surveyor Diveney at the hearing for cross‑examination.  I admitted into the record CMS Exs. 1-33 and P. Exs. 1-21.  I provisionally admitted exhibits containing the written direct testimony of witnesses scheduled to appear at the hearing (CMS Ex. 33 and P. Exs. 13, 14, and 15), pending authentication at the hearing.

On January 10, 2019, I held a hearing by video teleconference (VTC) and a transcript (Tr. I) was made of the proceeding.  I presided from the DAB offices in Washington, D.C.  Counsel for each party, and Petitioner's witnesses LPN Thomas, RN Frantz, and ADON Reiling appeared via VTC from the United States Bankruptcy Court for the Southern District of Iowa in Des Moines, Iowa.  Kendall Watkins, Esq., represented Petitioner and Wanda Cannick, Assistant Regional Counsel, represented CMS.  Civil Remedies Division (CRD) attorney-advisor Tony Tran also appeared and assisted me in the proceedings.  At the beginning of the hearing, CMS counsel advised me that the CMS witness, Surveyor Diveney, was unable to appear at the hearing, due to illness.  Tr. I at 5.  I ruled that we would take testimony from Petitioner's witnesses that day and reconvene at a later date to take testimony from CMS's witness.  Id. at 9.  I admitted CMS Exs. 1-32 and P. Exs. 1-21 into the record.  Id. at 14, 20, 38, 56.  During the hearing, counsel for CMS cross-examined Petitioner's three witnesses, with direct and redirect examination by Petitioner's counsel.

On February 1, 2019, I conducted a second telephone prehearing conference with the parties to discuss obtaining the testimony of CMS's witness, Surveyor Diveney.  On February 5, 2019, I issued a Notice of Continuation of Hearing, in which I found good cause to permit Surveyor Diveney to provide testimony from her home via smart phone and scheduled the resumption of the hearing in this case for February 19, 2019.6   On February 19, 2019, I held a continued video/telephone hearing and a transcript was made of the proceeding.  Tr. II.  I presided from the DAB office in Washington, D.C.  Counsel for the parties appeared from their respective offices, and Surveyor Diveney appeared from her home by smart phone with video capability.  CRD Team Lead Elizabeth Fischer-Laurie also appeared and assisted me with the proceedings.  During the hearing, counsel for Petitioner cross‑examined Surveyor Diveney, who conducted the survey of Petitioner's facility, with direct and redirect examination by CMS counsel.  I admitted Surveyor Diveney's written direct testimony into the record as CMS Ex. 33.  Id. at 9.

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Following the continued hearing, each party submitted a post-hearing brief (CMS Posthrg. Br., P. Posthrg. Br.) and a reply brief (CMS Reply, P. Reply).

II.  Issues

The issues in this case are:

1. Whether Petitioner failed to comply substantially with Medicare participation requirements; if not
2. Whether CMS's determination of immediate jeopardy was clearly erroneous; and
3. Whether the CMP amount is reasonable.

III.  Jurisdiction

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

IV.  Burden of Proof

CMS must make a prima facie showing that Petitioner failed to comply substantially with federal participation requirements.  If this occurs, Petitioner must prove substantial compliance by a preponderance of the evidence in order to rebut CMS's showing and to prevail.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff'd sub nom Hillman Rehab. Ctr. v. U.S. Dep't of Health & Human Servs., No. Civ. A 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff'd sub nom 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).

V.  Discussion

A. Statutory and Regulatory Framework

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

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

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. §§ 488.10, 488.20.  The Act and regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A) (42 U.S.C. § 1395i-3(g)(2)(A)); 42 C.F.R. §§ 488.20(a), 488.308.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that are not in substantial compliance with the program participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  Among other enforcement remedies, CMS may impose a per-day CMP for each instance of noncompliance, whether or not the deficiencies are at the immediate jeopardy level of noncompliance.  42 C.F.R. § 488.430(a).  CMS may also impose a per-day CMP for the number of days of past noncompliance, including deficiencies at the immediate jeopardy level.  42 C.F.R. § 488.430(b).  At the time of the April 2017 survey at issue in this case, the range for a per-day CMP at the immediate jeopardy level was $6,394 - $20,965, while the range for a per-day CMP that did not constitute immediate jeopardy was $105 - $6,289.  42 C.F.R. § 488.438(a)(1); 45 C.F.R. § 102.3; see also 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).

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

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

Resident #1 was an 85-year-old man who was admitted to Petitioner's facility in 2012.  CMS Ex. 7 at 1‑2.  Resident #1's diagnoses included paraplegia, essential primary hypertension, chronic atrial fibrillation, presence of pacemaker, peripheral vascular disease, and multiple co-morbidities.  Id. at 11-12; see also CMS Ex. 11 at 1.  The Minimum Data Set (MDS) assessment, dated January 20, 2017, indicates that

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Resident #1 had a Brief Interview for Mental Status (BIMS) score of 15,7 was independent in wheelchair locomotion on and off his unit, required extensive assistance with bed mobility, and was totally dependent for assistance with transfers.  CMS Ex. 7 at 4, 8, 23.  His care plan, with focus area initiation date January 31, 2014, documented that Resident #1 was "full code" for resuscitation when non-responsive, did not want intubation, but did want cardiopulmonary resuscitation (CPR), medications, electroshock stimulation, and call 911 emergency.  CMS Ex. 8 at 9; CMS Ex. 9.  Resident #1 also designated the facility as his home, with no plans for discharge and return to the community.  CMS Ex. 8 at 6.

On March 30, 2017, Resident #1 fell from his "electric wheelchair" or "electric scooter" while crossing the doorway threshold into a restaurant while on a lunch outing with facility activities staff and other residents.8   CMS Ex. 26 at 1, 3; see also CMS Exs. 23, 27.  Petitioner self-reported this fall using an online reporting system, completing the report on March 31, 2017.  Id. at 1.  The report indicates that Resident #1

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was assisted back into his wheelchair by volunteer bus driver Les Wiley (Driver Wiley) and the restaurant owner, reported no pain at that time, and refused to be transported back to the SNF for assessment.  CMS Ex 26 at 1, 6.  Although Resident #1 refused to be transported back to the SNF before having his meal, Activities Director Hope Wiley (AD Wiley) nonetheless reported the incident to ADON Reiling, by telephone.  Id. at 3, 5.  ADON Reiling did not require the activities staff to return Resident #1 to the facility at that time.  Id.  She also reported the incident to Petitioner's Administrator.  Id.  AD Wiley reported that Resident #1 complained that his knee hurt only after he had finished his meal.  Id. at 3.  Resident #1 returned to the facility with the group on the bus around 1:00 PM.  Id. at 3, 5.  Resident #1 had no visible signs of injury, but stated that his right leg hurt and rubbed his right thigh and knee.  Id. at 5.  At the facility, Resident #1 was transferred from his wheelchair into his bed by Hoyer lift for further nursing assessment.  Id.

A nurses' note for March 30, 2017 (13:06) entered by Ann Lorenzen, LPN (LPN Lorenzen), documents that Resident #1 described that he had difficulty getting his electric wheelchair into the restaurant, because it got "hung up on the lip of the doorway entrance."  CMS Ex. 11 at 7.  He reported backing his wheelchair up, "floored it to get through the door way," and "hit the door way and fell out of my chair . . . ."  Id.  LPN Lorenzen documented that her physical assessment of Resident #1 did not reveal any obvious signs of injury.  Id.  She notified Resident #1's physician, who ordered x-rays.  Id.  The x-rays revealed a right proximal femur fracture.  CMS Ex. 25 at 2.  Resident #1 was then transported by ambulance to an acute care hospital for further treatment.  CMS Ex. 11 at 7.  Resident #1 underwent surgical repair of a right proximal third femur fracture on April 3, 2017.  CMS Ex. 24 at 1; see also CMS Ex. 11 at 3-4.

Resident #1 returned to the facility on April 5, 2017, and was assessed at 4:00 PM on his readmission from the hospital.  CMS Ex. 10 at 1; CMS Ex. 11 at 3-4.  When assessed on readmission, Resident #1 was alert and oriented x 4, was lucid and spoke clearly, and "wanted to get in his motorized wheelchair but resident appeared tired and so RN suggested resident lay down for a while rather than staying up in his wheelchair.  Resident agreeable."  CMS Ex. 11 at 3.  Resident #1's "skin was pale, warm and dry," his pulses palpable but weak peripheral pulses in bilateral feet, respiration was non-labored, and "[c]hronic vascular discoloration throughout lower extremities [was] noted."  Id.  He was "able to follow directions and control upper [extremities] per usual."  Id.  He asked the nurse to position the partial side rail of his bed so that he could "pull himself over in the bed and turn for repositioning.  Resident demonstrated ability to turn his upper body. . . .  Nursing personnel continued working with resident when RN exited resident room."  Id.

The facility had a video camera surveillance system, with time-stamp recording on the video image and a camera that captured activity at Resident #1's doorway.   CMS Ex. 14; P. Exs. 6-11; P. Ex. 13 ¶ 9; P. Ex. 14 ¶ 7.  The following describes some of the recorded

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staff activity in and around Resident #1's doorway in the afternoon and evening of April 5, 2017, based on review of the time-stamped video clips entered into the record:

• At 16:47:05 (4:47:05 PM), LPN Thomas entered Resident #1's room and exited at 16:50:13 (4:50:13 PM).  P. Ex. 6; P. Ex. 13 ¶ 13.
• At 17:49:29 (5:49:29 PM), RN Frantz entered Resident #1's room and exited at 17:49:38 (5:49:38 PM), closing the door to the room.  P. Ex. 7; P. Ex. 14 ¶ 9.
• At 19:14:04 (7:14:04 PM), LPN Thomas opened the door and entered Resident #1's room, exited at 19:14:46 (7:14:46 PM), then re-entered at 19:14:54 (7:14:54 PM).  P. Ex. 8; P. Ex. 9; P. Ex. 13 ¶¶ 14-17.
• At 19:15:05 (7:15:05 PM), Certified Nurse Assistant Mere Coltrain (CNA Coltrain) stopped walking in the hallway and stood a little more than halfway from Resident #1's doorway and the opposite wall.  P. Ex. 9.
• LPN Thomas exited the room at 19:15:06 (7:15:06 PM) and did not acknowledge or interact with CNA Coltrain.  Id.
• From 19:15:08 through 19:15:10 (7:15:08 PM to 7:15:10 PM), CNA Coltrain took three steps to the left while remaining in the middle of the hallway and facing Resident #1's doorway, then walked away to the right without returning to her prior observation point.  Id.
• At 19:15:41 (7:15:41 PM), LPN Thomas entered Resident #1's room, closely followed by RN Frantz who entered at 19:15:43 (7:15:43 PM).  P. Ex. 9; P. Ex. 10; P. Ex. 13 ¶¶ 19-20; P. Ex. 14 ¶¶ 10-11.  While CNA Coltrain came down the hallway at this time, she remained on the opposite wall and did not look into Resident #1's doorway before disappearing from the video at 19:15:48 (7:15:48 PM).  P. Ex. 10.  LPN Thomas exited Resident #1's room at 19:16:07 (7:16:07 PM); RN Frantz exited at 19:16:09 (7:16:09 PM), closing the door behind her.  P. Ex. 10; P. Ex. 13 ¶ 21; P. Ex. 14 ¶ 12.
• At 19:21:29 (7:21:29 PM), RN Frantz entered Resident #1's room, closing the door behind her; she exited at 19:23:20 (7:23:20 PM), again closing the door behind her.  P. Ex. 11; P. Ex. 14 ¶ 13.

A nurses' note, dated April 5, 2017, at 22:09 (10:09 PM), states that the author (LPN Thomas) assisted an RN, the ADON, and 2 CNAs return Resident #1 to his bed from his

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"high back" wheelchair using a Hoyer lift, following his return from the hospital at 15:30 (3:30 PM).  CMS Ex. 11 at 1; P. Ex. 13 ¶ 23; Tr. I at 25.  The note documents a "skin check" revealing three Stage 1 pressure ulcers and that Resident #1 would be evaluated for strength and mobility, as well as for an electric wheelchair "until evaluation to use high back [wheelchair]."  CMS Ex. 11 at 1.  The entry also states that a nurse closed the door to Resident #1's room at "1800," as Resident #1 was sleeping.  Id.  At 19:15, when LPN Thomas entered Resident #1's room, he was "not breathing not responding to verbal or tactile stimuli," and she "call[ed] to RN [Frantz] to affirm initial assessment."  Id.  The author then wrote:  "Body is cool to touch.  Skin is jaundiced.  No palpable pulses, no respirations, no BP."  Id.  RN Frantz instructed LPN Thomas to call Resident #1's physician immediately, who "accepted the assessment of death" and gave the "verbal order not to initiate CPR."  Id.; see also CMS Exs. 20, 21 (letters from Resident #1's physician).  The note then discusses contact and arrangements with the family, funeral home, and medical examiner.  CMS Ex. 11 at 1.

On April 7, 2017, LPN Thomas spoke by telephone with Director of Clinical Operations Deborah Jamison, RN (Director Jamison), 9 concerning LPN Thomas's observations and actions surrounding the death of Resident #1.  P. Ex. 13 ¶ 24; P. Ex. 16 ¶ 5.  Director Jamison had access to Resident #1's electronic medical records from her office and advised LPN Thomas that the record did not reflect all observations and assessments related by LPN Thomas in the telephone conversation.  P. Ex. 13 ¶ 24; P. Ex. 16 ¶ 5.  Director Jamison advised LPN Thomas to review her record notes concerning Resident #1's death, make a late entry for observations and assessments not included in the original note, and ensure that documentation of her assessments and observations was complete.  P. Ex. 13 ¶ 24; P. Ex. 16 ¶ 5.  Both LPN Thomas and Director Jamison testified that Director Jamison did not tell LPN Thomas what to document.  P. Ex. 13 ¶ 24; P. Ex. 16 ¶ 5.  On April 7, 2017, "after 2:00 p.m.," LPN Thomas added two late entries to nurses' notes in the record.  P. Ex. 13 ¶ 24; CMS Ex. 11 at 2.  With respect to Resident #1's condition, she wrote:  "Additional assessment findings are as follows.  Mouth open teeth falling out.  Noted BLE [bilateral lower extremity] knees down purple, red in color.  Lying on left side noted with increased distention, and bloating to left later[al] ABD [abdomen]."  CMS Ex. 11 at 2.  She also wrote that Resident #1's son asked whether CPR was initiated and thanked her when she answered "no."  Id.

On April 7, 2017, RN Frantz also spoke with Director Jamison concerning RN Frantz's assessment of the death of Resident #1.  P. Ex. 14 ¶ 14; P. Ex. 16 ¶¶ 3-4.  RN Frantz testified that because LPN Thomas had been Resident #1's charge nurse on the day of his death, and conducted the initial assessment after finding Resident #1 unresponsive, RN

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Frantz "did not document my assessment of the resident that evening."  P. Ex. 14 ¶ 14.  Director Jamison contacted RN Frantz and stated that because RN Frantz also assessed Resident #1, she "needed to document [her] assessment and observations in the clinical record, which [she] did as late entries during [her] shift on April 7, 2017, shortly after 1:30 p.m."  Id.  RN Frantz testified that she did not consult LPN Thomas or review LPN Thomas's entries before making her own late entry.  Id.  RN Frantz also testified:  "Ms. Jamison did not tell me what to document, but only gave instructions to document all of my observations made as part of my assessment.  Late entries are an acceptable method of charting in a resident's clinical record."  Id.  The nurses' notes for Resident #1 contain, in relevant part, the following late entry by RN Frantz:

This Nurse goes to [Resident #1's] room and finds him nonresponsive.  No respirations.  His skin was jaundiced, cool to touch, no palpable pulse, no BP obtainable.  Circumoral cyanosis10 noted.  Mouth was agape with dentures falling out of mouth.  Jaw stiffened.  Abdominal bloating and significant distension observed.  Feet and hands were very cold/stiffened.  [Resident #1] appeared to be deceased for some time.  This Nurse chose not to initiate CPR because of these assessment findings.  A Stat call was placed to [Resident #1's physician] with immediate response to report assessment at which time she gave orders not to attempt CPR.  DON and Family notified.

CMS Ex. 11 at 2.  A second late entry states that Resident #1 "was laying on his left side in bed during assessment period.  Large accumulation/pooling of fluid was palped on [left lateral abdomen]."  Id.

At all times relevant to this case, Petitioner had in effect its "Kennybrook Village CPR Policy" (CPR Policy), which states its objective is to determine when CPR must be initiated, consistent with federal law requirements to effect a resident's advance directive.  CMS Ex. 22 at 1.  The CPR Policy states that on determining "that a resident is in cardiopulmonary or respiratory arrest (note the time), CPR will be immediately initiated by nursing staff and 911 called," unless an exception applies, including:  "When there is the presence of obviously clinical signs of irreversible death (defined as rigor mortis or dependent lividity) . . . ."  Id. (emphasis original).  The CPR Policy also states:  "If a nurse's assessment concludes that the resident exhibits signs of irreversible death leading to nursing judgment not to initiate CPR, complete and contemporaneous documentation

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of the nursing assessment shall be documented in the clinical record."  Id. at 2.  The CPR Policy includes the following definitions:

• Cardiopulmonary arrest:  physiologic state wherein the resident actually has no palpable pulse and no spontaneous respirations.
• Dependent lividity:  means clear demarcation of pooled blood within the body, seen in a dependent part of the body, occurring as a sign of irreversible death.
• Rigor mortis:  means that major joints such as the jaw, shoulders, elbows, hips, or knees are immovable; this is a sign of irreversible death.

Id. at 1;  cf. P. Ex. 1 at 2 (2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (AHA Guidelines));  P. Ex. 2 at 11 (CMS guidance on "Cardiopulmonary Resuscitation (CPR) in Nursing Homes," revision date Jan. 23, 2015, reflecting Appendix PP draft guidance revisions for Tag F155).

State Investigation

On April 10, 2017, Surveyor Diveney was scheduled to begin a survey of Petitioner's facility to investigate the self‑reported fall of Resident #1 from his mobility device.  CMS Ex. 26 at 2; CMS Ex. 33 ¶ 11.  The survey was completed on April 26, 2017.  CMS Ex. 1 at 1; CMS Ex. 6 at 1; P. Ex. 3 at 1.  As part of the survey process, Surveyor Diveney interviewed members of Petitioner's staff and reviewed facility video recordings and records.  CMS Ex. 4; CMS Ex. 14.  Surveyor Diveney made handwritten notes of the interviews and reviews at or about the times she conducted the interviews and reviews.  CMS Exs. 12-19, 28, 29.  Surveyor Diveney prepared the Statement of Deficiencies, which set forth the results of her survey and deficiencies assessed.  P. Ex. 3 at 1; CMS Ex. 6 at 1; CMS Ex. 33 ¶ 13; Tr. II at 9-10.

According to Surveyor Diveney's interview notes dated April 13, 2017 (1:59 PM), CNA Claire Gehring (CNA Gehring) first stated that she at no time entered Resident #1's room on April 5, 2017.  CMS Ex. 16 at 1.  However, a second entry on the same day (2:45 PM) states that CNA Gehring entered Resident #1's room at "19:08" (7:08 PM), at the direction of RN Frantz in search of gowns.  Id. at 2.  According to Surveyor Diveney's notes, CNA Gehring said she "[d]id not go to res bedside, he was lying in bed and had one eye open.  I did not say anything & neither did he."  Id.  Surveyor Diveney's typewritten notes of an interview with CNA Gehring on April 26, 2017 (2:35 PM) state:  "[S]he does not recall if Resident #1 was on his back or side when [she] entered room

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. . . , he had one eye open, mouth open, don't [sic] recall if dentures coming out of mouth or not, he was probably on his back."  CMS Ex. 17 at 1 (emphasis added).11

Surveyor Diveney also made typewritten notes of an interview with CNA Coltrain on April 26, 2017 (1:30 PM).  Id.  According to the notes, CNA Coltrain stated that, when she was in the hallway outside Resident #1's room on April 5, 2017, "around 7:15 pm," she could see the resident, who "was still on his back with blankets pulled up to abdomen."  Id.  Also according to the notes, she stated that when she later was asked to "clean the resident up to transfer, he was cold but not [too] cold, a little warm, not stiff, his mouth opened with dentures protruding out, skin pale."  Id.

Following IDR/IC, the reviewer issued a decision, dated June 26, 2017, in which she concluded that the original SOD (P. Ex. 3) incorrectly reported that RN Frantz entered Resident #1's room with LPN Thomas at 7:21:34 PM.  P. Ex. 3 at 5.  The reviewer directed that the SOD be modified to reflect the correct time of entry, 7:15:43 PM.  Id.; see also CMS Ex. 14 at 3; compare P. Ex. 3 at 7 with CMS Ex. 6 at 7.12   The corrected SOD is found at CMS Ex. 6.

Testimonial Evidence

Petitioner offered written statements under oath from:  (1) LPN Thomas; (2) RN Frantz; (3) ADON Reiling; (4) Director Jamison; (4) Gwen Suntken, RN (expert witness) (Ms. Suntken); (5) Stephen E. Godfrey, MD (expert witness) (Dr. Godfrey).  I overruled CMS's objection to Petitioner's untimely request to cross-examine Petitioner's witnesses, and counsel for CMS cross-examined LPN Thomas, RN Frantz, and ADON Reiling at the hearing on January 10, 2019.  Tr. I at 18-29, 37-47, 55-58.  Petitioner additionally offered a transcript of the deposition of Surveyor Diveney, taken August 24, 2017.  P. Ex. 21.  CMS offered the written direct testimony of Surveyor Diveney as CMS Ex. 33.  Counsel for Petitioner cross-examined Surveyor Diveney at the continuation of the hearing on February 19, 2019.  Tr. II.

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Petitioner's witnesses LPN Thomas, RN Frantz, and ADON Reiling testified that, prior to 7:15 PM on April 5, 2017, the baseline coloration of Resident #1's lower extremities (below the knees) was normally tan and light brown as the result of his chronic peripheral vascular disease.  P. Ex. 13 ¶ 4; P. Ex. 14 ¶ 4; P. Ex. 15 ¶ 5; Tr. I at 30-31, 50‑51; see also P. Ex. 4 at 4  (March 30, 2017 physician consult note documenting "large hemosiderin deposits" 13 on Resident #1's left lower leg, with right leg wrapped and splinted down to foot).  At 4:00 PM on April 5, 2017, ADON Reiling conducted and charted a head‑to‑toe assessment of Resident #1 on readmission to the facility, at which LPN Thomas and other staff were present, and documented "[c]hronic vascular discoloration throughout lower extremities noted."  P. Ex. 15 ¶ 3; see also CMS Ex. 11 at 3; P. Ex. 13 ¶ 10; Tr. I at 30-31 (LPN Thomas testimony).  At 4:47 PM, LPN Thomas entered Resident #1's room to apply cream to his lower legs, which she testified had "normal" light brown and tan coloration at that time.  P. Ex. 13 ¶ 13; see also CMS Ex. 11 at 1; P. Ex. 6.  At 5:49 PM (17:49), RN Frantz briefly entered Resident #1's room, spoke with him, then exited and closed the door behind her at his request.  P. Ex. 14 ¶ 9; P. Ex. 7.

At 7:14 PM (19:14), LPN Thomas entered Resident #1's room, exited, re-entered, then exited again in about one minute.  P. Ex. 13 ¶¶ 14-17; see also P. Ex. 8; P. Ex. 9.  Approximately 30 seconds later, LPN Thomas and RN Frantz both entered Resident #1's room.  P. Ex. 13 ¶¶ 19-21; P. Ex. 14 ¶¶ 10, 11; see also P. Ex. 9; P. Ex. 10.  Approximately 30 seconds later, both LPN Thomas and RN Frantz exited Resident #1's room, and RN Frantz closed the door behind her.  P. Ex. 13 ¶ 21; P. Ex. 14 ¶ 12; see also P. Ex. 10.  LPN Thomas charted this series of actions in an entry dated April 5, 2017 at 22:09 (10:09 PM), in which she stated that Resident #1 was non-responsive when she first entered his room and did not respond to verbal or tactile stimulation, his body was cool to touch, skin jaundiced, no palpable pulses or respiration.  P. Ex. 13 ¶¶ 14-17, 23; see also CMS Ex. 11 at 1.  RN Frantz confirmed LPN Thomas' assessment and instructed LPN Thomas immediately to telephone Resident #1's physician, who gave the verbal order not to initiate CPR and "accepted the assessment of death."  P. Ex. 13 ¶ 21; see also CMS Ex. 11 at 1; CMS Exs. 20, 21 (letters written by Resident #1's physician).

A late entry note by LPN Thomas, which is not dated or time-stamped,14 provides additional assessment findings, including:  "Mouth open teeth falling out.  Noted BLE

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knees down purple, red in color.  Lying on left side noted with increased distention, and bloating to left lateral [abdomen]."  CMS Ex. 11 at 2; see P. Ex. 13 ¶¶ 15, 16.  LPN Thomas testified that she made these late entries after 2:00 PM on April 7, 2017, at the direction of Director Jamison to ensure that her assessments and observations on April 5 were complete.  P. Ex. 13 ¶ 24; P. Ex. 16 ¶ 5 (written testimony of Director Jamison).  A late entry note by RN Frantz, effective April 5, 2017 (19:15) states that LPN Thomas alerted RN Frantz that Resident #1 was nonresponsive and RN Frantz's assessment included "circumoral cyanosis," "jaw stiffened," and "feet and hands were very cold/stiffened.  [Resident #1] appeared to be deceased for some time."  CMS Ex. 11 at 2.  RN Frantz's written testimony also states that "[b]oth legs below the knee were dark purple and red.  The purple/red discoloration was significantly different from my observations of this resident's baseline condition where his skin was light brown/tan with darker brown spots."  P. Ex. 14 ¶ 10.  RN Frantz testified that she initially did not record a nurses' note because LPN Thomas was Resident #1's charge nurse; however, RN Frantz made the late entry shortly after 1:30 PM on April 7, 2017, following a telephone conversation with Director Jamison.  Id. ¶ 14.

LPN Thomas, RN Frantz, and Director Jamison all testified that Director Jamison did not tell LPN Thomas or RN Frantz what to document, but to document their complete assessments and findings.  P. Ex. 13 ¶ 24; P. Ex. 14 ¶ 14; P. Ex. 16 ¶¶ 4, 5.  Petitioner's expert witness, Ms. Suntken, testified on written direct that late entry charting is an acceptable nursing practice so long as the entry is identified as a late entry, the author has "total recall of the omitted information and the entry is made as soon as reasonably possible."  P. Ex. 17 ¶ 21; see also P. Ex. 19; P. Ex. 13 ¶ 24; P. Ex. 14 ¶ 14.  Further, according to Ms. Suntken, late entries "are considered part of the contemporaneous record."  P. Ex. 17 ¶ 21.

Ms. Suntken also testified that LPN Thomas and RN Frantz had sufficient time in Resident #1's room to assess him for signs of irreversible death.  Id. ¶¶ 12-14.  She further opined that dependent lividity can be first visible 20-30 minutes after a heart stops beating, and that rigor mortis is initially detected in a body's smaller muscles, including the jaw, and can first appear "as early as one hour after death."  P. Ex. 17 ¶¶ 16, 17.  Petitioner's expert physician witness, Dr. Godfrey, testified that, based on his review of the survey and clinical records, the observations and assessments by LPN Thomas and RN Frantz included "such irreversible signs of a postmortem interval as livor mortis" (dependent lividity) and rigor mortis.  P. Ex. 18 ¶¶ 3, 4.  Dr. Godfrey also averred that

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dependent lividity and rigor mortis in small muscles of the face "begin[] as early as one hour after death."  Id. ¶¶ 4, 5.

2.  Petitioner substantially complied with the Medicare participation requirements at 42 C.F.R. §§ 483.10(c)(6), (8), (g)(12), and 483.24 (a)(3) (Tag F155).

SNF residents have the right "to request, refuse, and/or discontinue treatment" and "to formulate an advance directive."  42 C.F.R. § 483.10(c)(6).  See also 42 C.F.R. § 483.10(c)(8) (subsection 483.10(c) does not give residents the right to receive medical treatment or medical services deemed medically unnecessary or inappropriate); 42 C.F.R. § 483.10(g)(12) (requiring facilities to inform residents in writing of their right to formulate an advance directive).  An advance directive is "a written instruction, such as a living will or durable power of attorney for health care . . . relating to the provision of health care when the individual is incapacitated."  42 C.F.R. § 489.100.  The State Operations Manual (SOM) similarly provides that an advance directive could be a living will, a directive to the attending physician, a durable power of attorney for health care, a medical power of attorney, a pre-existing medical order for "do not resuscitate (DNR)," or another document that directs the resident's health care.  SOM, CMS Pub. 100-07, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (Rev. 168, eff. March 8, 2017).15

There is no dispute that Resident #1 was a "full code" patient, who had requested CPR, medicines, and electro-shock interventions (but no intubation) if found non-responsive.  CMS Ex. 9; CMS Ex. 8 at 9.  There is also no dispute that both Petitioner's CPR Policy and the AHA Guidelines allow for CPR to be withheld from a full code patient when the patient exhibits clinical signs of irreversible death, including rigor mortis or dependent lividity.  CMS Ex. 22 at 1; P. Ex. 1 at 2.  Resident #1 was last documented as alive and responsive at 5:49 PM on April 5, 2017, and was first assessed as non-responsive at 7:14 PM, a period of 1 hour and 25 minutes later.  P. Ex. 14 ¶¶ 9, 10; P. Ex. 13 ¶ 14.

CMS contends that Petitioner failed to comply with 42 C.F.R. § 483.10(c)(6) because, when LPN Thomas found Resident #1, a full code patient, unresponsive, she did not immediately initiate CPR and call 911.  CMS Br. at 11-14; CMS Posthrg. Br. at 3-8; CMS Reply at 1-7.  CMS's view that Petitioner's staff unreasonably withheld CPR from Resident #1 depends almost entirely upon Surveyor Diveney's opinion that Resident #1 did not, in fact, exhibit clinical signs of irreversible death when LPN Thomas and RN Frantz assessed him at or around 7:15 p.m. on April 5, 2017.  The evidence on which

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CMS relies includes Surveyor Diveney's summaries of her findings in the Statement of Deficiencies, her sworn written and hearing testimony, and her notes of witness interviews.  CMS Ex. 6 at 1-12; CMS Ex. 33; Tr. II; CMS Exs. 12-13, 15-19.  Other than Surveyor Diveney, CMS did not present the sworn written direct testimony of any witness.

In support of its position that it substantially complied with the requirement to respect residents' advance directives and to provide CPR when appropriate, Petitioner offered the written direct and hearing testimony of LPN Thomas, RN Frantz, and ADON Reiling.  P. Exs. 13-15.  Petitioner also offered the written direct testimony of Director Jamison and its expert nursing and physician witnesses, Ms. Suntken and Dr. Godfrey.  P. Exs. 16-20.  CMS did not request to cross-examine Director Jamison or Petitioner's expert witnesses, whose written direct testimony is thus uncontested.

Surveyor Diveney's opinion that Resident #1 did not exhibit clinical signs of irreversible death is based on two assumptions which the evidence establishes were unfounded.  First, Surveyor Diveney assumed that the mere fact that LPN Thomas and RN Frantz documented some of their observations and assessments of Resident #1 in late entries rendered those entries unreliable.  Second, Surveyor Diveney assumed that the red or purple discoloration of Resident #1's lower extremities was related to his diagnosis of peripheral vascular disease and was not a sign of dependent lividity.  In the paragraphs that follow, I explain why the preponderance of the evidence supports conclusions contrary to those reached by Surveyor Diveney and on which CMS relies.

In contending that the late entries in Resident #1's medical record are unreliable, CMS asserts that the conversations that LPN Thomas and RN Frantz had with Director Jamison two days after Resident #1's death, and prior to making the late entry clinical notes, make the late entries suspect.  CMS Br. at 13 ("[C]hanges made are self-serving [to] justify the facility's actions.").  This view was obviously shared by Surveyor Diveney, who testified that, among other things, she "question[s] . . . a late entry done . . . a couple of days or so after the fact and by instructions of the corporate nurse."  Tr. II at 24; see also id. at 86.  Nevertheless, I find that the credible testimony of LPN Thomas, RN Frantz, and Director Jamison establishes that Director Jamison did not influence LPN Thomas or RN Frantz to record any particular clinical observations, much less to fabricate them.  LPN Thomas, RN Frantz, and Director Jamison all testified that Director Jamison discussed Resident #1's death with LPN Thomas and RN Frantz, stated that parts of the discussions were not documented in the patient's electronic medical records to which she had access, and directed both LPN Thomas and RN Frantz to make late entries reflecting their entire assessments and observations, without discussing content.  P. Ex. 13 ¶ 24, P. Ex. 14 ¶ 14, P. Ex. 16 ¶¶ 3-5.  Nothing in CMS's cross-examination of nurses Thomas and Frantz created any doubt on these points.  Tr. I at 21-29, 33-35, 38-47.  Finally, Petitioner's expert nursing witness, Ms. Suntken, testified that late entries are acceptable charting practices in nursing if they are clearly identified as such, the author has independent

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recall concerning the contents, and the entries are made as soon as reasonably practicable, and are considered "part of the contemporaneous record."  P. Ex. 17 ¶ 21.  As noted above, CMS did not request to cross-examine either Director Jamison or Ms. Sunken.

CMS additionally argues that the late entries are unreliable based on alleged inconsistencies between the entries and Surveyor Diveney's notes of interviews with CNAs Gehring and Coltrain (Staff C and Staff G).  See CMS Posthrg. Br. at 7-8; see also CMS Ex. 4.  I do not find that the CNAs' statements call into question the nurses' chart entries.  First, LPN Thomas and RN Frantz testified under oath and were subject to cross-examination.  The statements recorded by Surveyor Diveney are hearsay.  While hearsay is admissible in administrative proceedings, it is inherently less reliable than testimony under oath.  Second, the CNAs' statements are inconsistent with other evidence of record.  Specifically, CNA Gehring's statements to Surveyor Diveney change significantly over the course of three interviews in two weeks.  CNA Gehring's first statement (April 13, 2017, at 1:59 PM) reports that she never entered Resident #1's room.  CMS Ex. 16 at 1.  However, a second statement the same day (2:45 PM) instead reports that she entered Resident #1's room at 7:08 PM, but had no interaction with him and only observed him in bed with one eye open.  Id. at 2.  Finally, a typewritten statement recorded two weeks later (April 26, 2017, at 2:35 PM) states that she has no recollection of Resident #1's body position when she entered his room before opining that he "was probably on his back."  CMS Ex. 17 at 1.  Because of these inconsistencies, I accord little weight to CNA Gehring's statements.

Similarly, I find CNA Coltrain's statement to Surveyor Diveney unreliable in part because it was apparently taken three weeks after Resident #1's death on April 5, 2017.  See CMS Ex. 17.  In addition, and more importantly, CNA Coltrain's statement is contradicted by the video recording from April 5, 2017.  Based on CNA Coltrain's positioning in the hallway, halfway between Resident #1's doorway and the opposite wall for approximately two seconds, I do not find credible her statement that she had a clear view of Resident #1's body positioning from her vantage point.  CMS Ex. 17; P. Exs. 9, 10; see also P. Ex. 13 ¶ 20.  I note that when LPN Thomas and RN Frantz interacted with Resident #1, they both took at least two or three steps through his doorway into his room before entering completely or stepping out, while CNA Coltrain was at most halfway across the hallway from the doorway when she purportedly made her observation.  Compare, e.g., P. Ex. 6 at 16:47:05‑06; P. Ex. 7 at 17:49:29-35; and P. Ex. 8 at 19:14:03‑07 with P. Ex. 9 at 19:15:02-11.  Finally, contrary to CMS's arguments, I do not find that CNA Coltrain's observations describing Resident #1's body as still "a little warm [and] not stiff" when she prepared his body for transfer establish that he did not display clinical signs of irreversible death when nurses Thomas and Frantz assessed him earlier.  See CMS Posthrg. Br. at 7.  CNA Coltrain lacks the clinical training of either an LPN or an RN.  I therefore accord her observations less weight than those of LPN Thomas and RN Frantz.

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For the reasons just explained, I find that Petitioner has proved by a preponderance of the evidence that the late entries by LPN Thomas and RN Frantz are not unreliable.  To the contrary, I find it is more likely than not that the entries accurately record the clinical observations nurses Thomas and Frantz made concerning Resident #1's condition on April 5, 2017.  The nurses' notes describe and the nurses confirmed in testimony that, from 7:15 PM-7:16 PM on April 5, 2017, both nurses observed and assessed Resident #1 as non-responsive with clinical signs of irreversible death.  Those signs included dependent lividity (purple and red coloration of the lower extremities, in contrast to baseline tan and light brown baseline coloration) and, according to RN Frantz, signs of rigor mortis in Resident #1's jaw.  P. Ex. 13 ¶¶ 14-19; P. Ex. 14 ¶¶ 10-12; Tr. I at 29-33, 42-43, 50-51; CMS Ex. 11 at 1-2.

I find particularly compelling the testimony of nurses Thomas and Frantz that they assessed Resident #1 as displaying dependent lividity based on the purple or red skin coloration they observed on Resident #1's lower extremities on April 15, 2017, after the resident was found unresponsive.  They testified that this was distinctly different from the baseline coloration of Resident #1's skin that they had previously observed.  P. Ex. 13 ¶¶ 4, 13, 15; P. Ex. 14 ¶¶ 4, 10; see also Tr. I at 30-31, 51; P. Ex. 15 ¶¶ 3-5 (ADON Reiling observed Resident #1's lower extremities to be tan or brown when she assessed him at 4:00 PM on April 5, 2017).  By contrast, I find speculative and unreliable Surveyor Diveney's opinion that signs of dependent lividity were absent.  Surveyor Diveney's opinion that Petitioner's nurses incorrectly assessed Resident #1 as displaying dependent lividity was based on her assumption that the purple or red coloration the nurses observed after finding Resident #1 unresponsive was consistent with Resident #1's baseline.  However, Surveyor Diveney established no basis for this opinion.  Surveyor Diveney never examined or cared for Resident #1.  P. Ex. 21 at 22 (thumbnail page 84).  She acknowledged that she had no reason to disbelieve Petitioner's nurses' testimony that Resident #1's skin was tan or brown in color at his baseline, other than her general impression that patients diagnosed with peripheral vascular disease may display red or purple discoloration of their skin.  P. Ex. 21 at 20 (thumbnail pages 74-75); see also Tr. II at 34-37, 44-45, 52-53.  I therefore accord little weight to Surveyor Diveney's testimony on this point.

Finally, Petitioner offered credible, unrebutted expert testimony that Petitioner's nurses appropriately assessed Resident #1 as displaying clinical signs of irreversible death.  Ms. Suntken, Petitioner's nursing expert, testified that LPN Thomas and RN Frantz had sufficient time in Resident #1's room to assess him for signs of irreversible death.  She further opined that dependent lividity can be first visible 20-30 minutes after a heart stops beating, and that rigor mortis is initially detected in a body's smaller muscles, including the jaw, and can first appear "as early as one hour after death."  P. Ex. 17 ¶¶ 14-17.  Petitioner's expert physician witness, Dr. Godfrey, testified that, based on his review of the survey and clinical records, the observations and assessments by LPN Thomas and RN Frantz included "such irreversible signs of a postmortem interval as livor mortis"

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(dependent lividity) and rigor mortis.  P. Ex. 18 ¶¶ 3, 4.  Dr. Godfrey also averred that dependent lividity and rigor mortis in small muscles of the face "begin[] as early as one hour after death." Id. ¶¶ 4, 5.  Dr. Godfrey opined that withholding CPR from Resident #1 under these conditions complied with state and federal requirements.  Id. ¶ 10.

In summary, I find that Petitioner has proved by a preponderance of the evidence that it complied substantially with 42 C.F.R. §§ 483.10(c)(6), (c)(8), (g)(12) and 483.24 (a)(3) (Tag F155).  The evidence of record compels the conclusion that Resident #1 displayed clinical signs of irreversible death when observed and assessed by LPN Thomas and RN Frantz at or about 7:15 PM on April 5, 2017.  The nurses' observations supported withholding CPR under both Petitioner's CPR Policy and the AHA Guidelines, notwithstanding Resident #1's "full code" status.  I thus find that Petitioner was in substantial compliance with these regulatory requirements at the time of Resident #1's death on April 5, 2017.

3.  Because Petitioner was in substantial compliance with 42 C.F.R. §§ 483.10(c)(6), (c)(8), (g)(12), and 483.24(a)(3), no question remains as to whether its actions posed immediate jeopardy to resident health and safety.

4.  Petitioner did not substantially comply with the Medicare participation requirements at 42 C.F.R. § 483.25(d)(1), (2) (Tag F323).

Subsection 483.25(d) is part of the quality of care regulation at 42 C.F.R. § 483.25.  The regulation provides that "[q]uality of care is a fundamental principle that applies to all treatment and care provided to facility residents."  42 C.F.R. § 483.25.  Subsection 483.25(d) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

The facility must ensure that -

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

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

42 C.F.R. § 483.25(d)(1), (2).

Subsection 483.25(d)(1) requires that a facility address foreseeable risks of harm from accidents "by identifying and removing hazards, where possible, or, where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible."  Maine Veterans' Home - Scarborough, DAB No. 1975

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at 10 (2005) (explaining the inherent standard of care in section 483.25(h)(1)); The Bridge at Rockwood, DAB No. 2954 at 10 (2019) ("The correct question is whether the facility did what it reasonably could to ensure that all residents received supervision needed to 'mitigate foreseeable risks of harm' based on what it knew about the residents, their care needs, and the conditions in the facility.").16

Subsection 483.25(d)(2) requires that a facility take "all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents."  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take "all reasonable precautions against residents' accidents")), aff'g Woodstock Care Ctr., DAB No. 1726 (2000).  Facilities are given "the flexibility to choose the methods" they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods constitute an "adequate" level of supervision for a particular resident's needs.  Windsor Health Care Ctr., DAB No 1902 at 5 (2003), aff'd sub nom. Windsor Health Ctr. v. Leavitt, 127 F. App'x 843 (6th Cir. 2005).  The mere occurrence of an accident does not, by itself, prove that a facility provided inadequate supervision.  However, when "an accident does occur, the circumstances surrounding an accident (or apparent accident) may support an inference that the facility's supervision of a resident was inadequate."  Lake Park Nursing and Rehab. Ctr., DAB No. 2035 at 8 (2006) (citing St. Catherine's Care Center of Findlay, Inc., DAB No. 1964 (2005)).

As previously noted, CMS cited this deficiency after reviewing Resident #1's fall from his mobility device on March 30, 2017, while on a lunch outing with facility staff and other residents.  See discussion at pp. 7-8, supra; CMS Ex. 6 at 12-22.  CMS summarized the basis for the deficiency as follows:

[T]he facility failed to provide adequate supervision to ensure against hazards from self and elements in the environment . . . .  Resident #1 went on an outing to a restaurant with 3 other residents, the activity director and van driver.  The resident attempted to enter through a door and the threshold was raised and not accessible.  The resident "rammed" the

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threshold and fell out of the chair.  The resident did not receive supervision or assistance getting through the door.

CMS Ex. 6 at 13.

As I explain in greater detail below, the record developed before me does not demonstrate that Petitioner took "all reasonable measures" to protect Resident #1 from experiencing an accident.  See Briarwood Nursing Ctr., DAB No. 2115 at 11.  As such, Petitioner failed to "provide supervision and assistance devices that reduce known or foreseeable accident risks to the highest practicable degree, consistent with accepted standards of nursing practice."  Heritage Plaza Nursing Ctr., DAB No. 2829 at 6 (2017) (internal quotation marks omitted).

Petitioner argues primarily that the accident happened "very quickly" and was unforeseeable, in that "Resident #1's scooter knocked the door frame of the second door, and he slid out of his electric scooter."  P. Br. at 22.  Petitioner asserts that Resident #1 had no prior falls from his mobility device in his five years as a resident at the facility and that an occupational therapy assessment determined that he was able to independently operate the mobility device.  Id.; see also P. Ex. 5 at 2.  However, accepting all of Petitioner's assertions at face value, they do not establish that Petitioner provided Resident #1 with adequate supervision and assistance under the circumstances.

Petitioner's accident investigation report documents that, when Resident #1 was initially unable to cross the restaurant door threshold in his mobility device, he activated the device's "fast" mode and crossed the threshold, and he fell from the mobility device inside the restaurant at a second door.  CMS Ex. 26 at 3, 6.  Petitioner's volunteer driver and a restaurant employee assisted Resident #1 back onto his mobility device.  Resident #1 had no visible signs of injury and did not initially complain of pain.  Moreover, he refused to return to the facility before having lunch, and ADON Reiling advised AD Wiley by telephone to continue with lunch as planned and that Resident #1 would be assessed upon his return.  Id. at 3-6.

LPN Lorenzen assessed Resident #1 upon his return from the restaurant, as set forth in Petitioner's "Fall Scene Investigation Report" (report).  CMS Ex. 27; see also CMS Ex. 23 (witnessed fall report).  The report states, in part, that Resident #1 "forced" his mobility device "over lip of doorway" before he "tipped out of chair."  CMS Ex. 27 at 1.  The report states that Resident #1 backed up his mobility device, "took a run for it and dumped himself out."  Id.  Resident #1 stated that he "floored it" and passed over the door threshold before he fell.  Id. at 2.  The report states the root cause of the fall as an isolated incident because Resident #1 was in an unfamiliar environment and forced his mobility device through the doorway, causing him to lose control of the device, hit a wall and door frame, and falling.  Id. at 3.  The report includes Petitioner's plan that Resident #1 would be re‑evaluated by OT for mobility device safety.  Id. at 4.  The report author

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also spoke with AD Wiley about turning off the mobility device into "manual mode" when assisting Resident #1 through difficult passageways.  Id.  The contemporaneous nurses' note by LPN Lorenzen indicates that Resident #1's physician also ordered an x‑ray, which revealed an acute fracture of the right femur, and Resident #1 was transferred to a hospital for surgical repair of the fracture.  CMS Ex. 11 at 7; CMS Exs. 24, 25.

Petitioner offered the written direct testimony of ADON Reiling, which includes the following:

8.  Resident #1 has been a paraplegic since 1981, and utilized an electric scooter.  He was independent in his use of the scooter and was able to operate the scooter both in the facility and outside the facility, including leaving the facility grounds for social outings.  I am aware from a review of his clinical record and conversations with nursing staff that Resident #1 in his five-year history at [the facility] has never had a fall from his electrical scooter. . . .

9.  Resident #1's scooter had a seat belt, but despite repeated staff education regarding the safety benefits of using the seat belt, I am aware that Resident #1 repeatedly indicated that he did not wish to use the seat belt on his scooter.

P. Ex. 15 ¶¶ 8-9.

As ADON Reiling's testimony demonstrates, although Resident #1 had never fallen from his mobility device while at Petitioner's facility, Petitioner's staff knew that Resident #1 did not use the seat belt on his device.  Therefore, as soon as it became apparent that Resident #1's mobility device could not easily cross the restaurant threshold, it was foreseeable that attempting to cross the threshold might cause the device to stop or lurch unpredictably, which would create the risk that Resident #1 might fall from the device, as in fact happened.  Apparently, neither AD Wiley nor Driver Wiley were aware that Resident #1's mobility device could be placed in "manual mode" to allow one or more of them to assist Resident #1 in crossing the threshold.  Taking this step would likely have averted the accident that occurred.  Thus, facility staff did not take all reasonable steps to avoid the accident.  The accident resulted in actual harm to Resident #1, who sustained a fractured femur, requiring surgical repair.  Accordingly, because Petitioner's noncompliance caused more than minimal harm to a resident, Petitioner was not in substantial compliance with the participation requirement.  Having concluded that Petitioner did not comply substantially with 42 C.F.R. § 483.25(d)(1), (2) (Tag F323), I next consider whether the CMP imposed is reasonable.

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5. A CMP of $503 per day from April 5, 2017, through April 26, 2017, is reasonable in amount and duration.

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

The regulations specify that a per-day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,394 to $20,965 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2).17   The lower range of a CMP, $105 to $6,289 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  In assessing the reasonableness of a CMP amount, an administrative law judge considers the per-day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC, DAB No. 2186 at 28 (2008).  The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); see also 42 C.F.R. § 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29.

In this case, CMS imposed CMPs of $14,541 per day for two days from April 5, 2017, through April 6, 2017, and $503 per day for 20 days from April 7, 2017, through April 26, 2017.  I have found above that Petitioner substantially complied with 42 C.F.R. §§ 483.10(c)(6), (c)(8), (g)(12), and 483.24(a)(3); therefore, there is no basis to impose immediate jeopardy level CMPs for April 5 and 6, 2017.  However, because Petitioner was out of substantial compliance at the non-immediate jeopardy level, I determine

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de novo whether a CMP of $503 per day for 22 days of noncompliance (April 5, 2017, through April 26, 2016) is reasonable, based on the factors enumerated in the regulations.

Applying the regulatory factors, I find that Petitioner's noncompliance in this case was serious, in that Resident #1 sustained a fracture requiring surgical repair when he fell from his mobility device.  CMS Ex. 11 at 7; CMS Ex. 24.  The $503 per-day CMP that CMS imposed is less than ten percent of the maximum CMP that is authorized for deficiencies that do not pose immediate jeopardy to resident health and safety ($6,289 per day).  42 C.F.R. § 488.438(a)(1)(i), (d)(2).  I find that a CMP in the lower end of the range for non‑immediate jeopardy deficiencies is reasonable based on the seriousness of the noncompliance alone.  Indeed, given the serious consequences Resident #1 experienced as a result of Petitioner's noncompliance, the CMP amount is modest.

Petitioner has not argued (should I find substantial noncompliance existed) that it returned to substantial compliance earlier than April 26, 2017.  Accordingly, I find that the duration of the CMP, from April 5, 2017, through April 26, 2017, is reasonable.

VI.  Conclusion

For the reasons discussed above, I find that Petitioner substantially complied with the Medicare participation requirements defined at 42 C.F.R. § 483.10(c)(6), (c)(8), and (g)(12), 42 C.F.R. § 483.24(a)(3).  Accordingly, CMS lacked a basis to impose a CMP of $14,541 per day for two days.  Petitioner did not comply substantially with 42 C.F.R. § 483.25(d)(1), (2).  A CMP of $503 per day for 22 days ($11,066 in all) is reasonable in amount and duration.

1. I apply the regulations in effect at the time of the survey.  Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996).
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2. To protect the privacy of the resident and the resident's family, I refer to the resident by the identifier assigned during the survey.  The resident key for the survey is found at CMS Ex. 5.
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3. Following an Informal Dispute Resolution informal conference (IDR/IC), the reviewer directed that the Form CMS-2567 be modified to correct an error in reporting the times certain events occurred.  CMS Ex. 3 at 5.  In this decision, I also refer to the Form CMS‑2567 as the Statement of Deficiencies or SOD.
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4. Subsections (n)(1)-(3) of 42 C.F.R. § 483.25 pertain to the appropriate use of bed rails in a SNF, which is not at issue in this survey.  I thus do not further address this regulatory requirement.
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5. The staff key for the survey is found at CMS Ex. 4.
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6. CMS counsel represented during the January 10, 2019 hearing that Survey Diveney had retired from the state agency at the end of December 2018, but intended to participate in the hearing.  Tr. I at 70.
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7. BIMS scores are categorized into 3 levels:  intact/borderline cognition (13–15), moderate cognitive impairment (8–12), and severe cognitive impairment (0–7).  See, e.g., Kali S. Thomas et al., The Minimum Data Set 3.0 Cognitive Function Scale, 55 Med. Care e68, e69 (2017) (online article), available at https://insights.ovid.com/crossref?an=00005650-201709000-00011 (last visited Feb. 15, 2021).  Thus, Resident #1's BIMS score indicates that his cognition was intact.
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8. The statement of deficiencies describes Resident #1's mobility device using various terms, including "chair," "power wheelchair," "power chair," "motorized wheelchair," and "wheelchair."  CMS Ex. 6 at 13-14.  In its brief filed December 26, 2017, Petitioner asserts that Resident #1 "used both an electric scooter and wheelchair for locomotion around the facility" and later refers to Resident #1's "electric wheelchair" and "scooter."  P. Br. at 3, 10.  Petitioner also states that Resident #1 "operated a motorized wheelchair for over thirty-five years [and] has used his current scooter for approximately one year."  Id. at 9.  Medicare authority distinguishes power wheelchairs from scooters, as follows:  "Power mobility device (PMD) means a covered item of durable medical equipment that is a class of wheelchairs that includes a power wheelchair (a four-wheeled motorized vehicle whose steering is operated by an electronic device or a joystick to control direction and turning) or a power-operated vehicle (a three or four-wheeled motorized scooter that is operated by a tiller) . . . ."  42 C.F.R. § 410.38(c) (emphasis added).  If, as Petitioner asserts, Resident #1 used both a scooter and a power wheelchair, the record does not establish which device he was using during the lunch outing on March 30, 2017.  In any event, the type of device Resident #1 used is not material to any issue I must decide.  For clarity, I refer in this decision to his mode of conveyance as a mobility device.
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9. Director Jamison's written testimony indicates that she is "Director of Clinical Operations for Pivotal Healthcare, the company that manages Kennybrook Village."  P. Ex. 16 ¶ 1.
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10. Upon my questioning, RN Frantz testified that circumoral cyanosis means "[b]luing or discoloration of the lips."  Tr. I at 46.
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11. For unknown reasons, Surveyor Diveney's interviews of CNA Gehring and CNA Coltrain on April 26, 2017, appear as typewritten notes.  CMS Ex. 17.  Surveyor Diveney documented most of her interviews with other staff members in handwritten notes.  See CMS Exs. 12, 13, 15, 16.  Surveyor Diveney testified that she "could have" prepared contemporaneous handwritten notes of these interviews, but any such notes were not submitted into evidence.  Tr. II at 68-69.
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12. Surveyor Diveney testified that the time discrepancies resulted from a typographical error.  Tr. II at 14.  This explanation is consistent with her handwritten notes on video review.  CMS Ex. 14 at 3-6.
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13. "Hemosiderin" is defined as "an intra-cellular storage form of iron, found in the form of pigmented yellow to brown granules . . . ."  Dorland's Illustrated Medical Dictionary at 854 (31st ed. 2007).
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14. When cross-examining Surveyor Diveney, Petitioner's counsel represented that the facility's electronic medical record software identifies the date and time of late entries within the electronic medical record system.  Tr. II at 83.  The date and time of the late entries do not appear on the hard copy of the late entry notes admitted into evidence.  CMS 11 at 2.
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15. The cited transmittal is available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R168SOMA.pdf (last visited April 23, 2021).  The description of different types of advance directives appears at PDF page number 22 of the transmittal.
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16. In 2016, CMS issued a final rule that re-designated and revised the provisions of 42 C.F.R. Part 483.  See Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688, 68,828 (Oct. 4, 2016).  Prior to 2016, the content of subsections 483.25(d)(1) and (2) was codified at subsections 483.25(h)(1) and (2).  The decisions cited in this discussion section interpreted 42 C.F.R. § 483.25(h)(1) and (2).  I find it appropriate to rely on the reasoning of these decisions in the present case because there was no substantive change to the language when 42 C.F.R. § 483.25(h)(1) and (2) were re‑codified as § 483.25(d)(1) and (2).
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17. The CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102.  The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case.  See 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).
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