Golden Living Center - Morgantown, DAB CR5811 (2021)

DECISION

Following a survey by the West Virginia Office of Health Facility Licensure and Certification (state agency), the Centers for Medicare & Medicaid Services (CMS) concluded that Golden Living Center – Morgantown (Petitioner or facility) was not in substantial compliance with 42 C.F.R. § 483.25(h). Effective November 28, 2016, 42 C.F.R. § 483.25(h) was re-designated as 42 C.F.R. § 483.25(d).  81 Fed. Reg. 68,688, 68,860 (Oct. 4, 2016).  I apply the regulations in effect at the time of the survey.  See Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey).   CMS determined that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety and imposed a civil money penalty (CMP) of $12,341 per day for 120 days (from June 8, 2016, through October 5, 2016).  CMS also imposed a per day CMP of $403 for 69 days (from October 6, 2016, through December 13, 2016).  CMS determined Petitioner returned to substantial compliance as of December 14, 2016.  The total CMP imposed by CMS is $1,508,727.  Petitioner requested a hearing to challenge CMS’s findings and the remedies imposed.

Petitioner concedes that its staff removed side rails from a resident’s bed contrary to a physician’s order.  After the side rails were removed, the resident fell from bed and

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suffered injuries that ultimately led to his death.  The main thrust of Petitioner’s arguments and evidence in the present proceeding is not that it was at all times in substantial compliance with Medicare participation requirements, but that its noncompliance was less serious and shorter in duration than CMS concluded.  For the reasons explained in this decision, I find that Petitioner failed to prove that CMS’s finding of immediate jeopardy was clearly erroneous or that Petitioner returned to substantial compliance earlier than CMS alleged.  I further find that the CMP amounts imposed are reasonable.

I. Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Morgantown, West Virginia.  See e.g., CMS Exhibit (Ex.) 1 at 1.  State agency surveyors conducted an annual survey and complaint investigation at Petitioner’s facility from October 4, 2016 through October 17, 2016.  Id.  In a letter dated January 13, 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 and that the noncompliance represented immediate jeopardy to resident health and safety.  CMS Ex. 2.  CMS further informed Petitioner that it was imposing a per day CMP of $12,341 for each of the 120 days of immediate jeopardy (from June 8, 2016, through October 5, 2016) and an additional per day CMP of $403, effective October 6, 2016, until Petitioner returned to substantial compliance.  Id. at 2.  In a letter dated January 19, 2017, CMS stated that Petitioner had returned to substantial compliance and that the $403 CMP had stopped accruing as of December 13, 2016.  CMS Ex. 3 at 1.  CMS further informed Petitioner that the total amount of the CMPs was $1,508,727.  Id.

Petitioner timely requested a hearing, and the case was assigned to me.  I issued an acknowledgment and prehearing order (Prehearing Order) establishing a briefing schedule.  In accordance with that schedule, the parties 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 two witnesses.  CMS Exs. 4, 5.  Petitioner offered the written direct testimony of one witness.  P. Ex. 7.  Petitioner requested to cross-examine only one of CMS’s witnesses.  CMS requested to cross-examine Petitioner’s witness.

On June 21, 2018, I held a hearing via video-teleconference (VTC), and a transcript (Tr.) was made of the proceeding.  I presided from the Departmental Appeals Board office in Washington, D.C.  Counsel for each party and the witnesses appeared via VTC from Morgantown, West Virginia.  Joseph Bianculli, Esq., represented Petitioner.  Eric Wolfish, Esq. and Frederick Wu, Esq., represented CMS.  I admitted CMS Exs. 1-39 and P. Exs. 1-7.  See Tr. at 14, 25, 174.  During the hearing, counsel for Petitioner cross-examined Ms. Jeannie Monahan, a state agency surveyor, and counsel for CMS cross-examined Petitioner’s administrator, Ms. Linda Dailey.

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

II. Issues

Petitioner conceded that it failed to comply substantially with Medicare participation requirements.  Tr. at 273-74. At the hearing, Petitioner’s counsel stipulated that the removal of Resident 126’s side rails was a deficient practice.  Tr. at 273-75.  At that time, I understood Petitioner to be stipulating that it was noncompliant with 42 C.F.R § 483.25(h).  Counsel for CMS interpreted the stipulation as I did, stating, “if [Petitioner is] willing to stipulate that a deficiency was present, it seems like the main issues to address in post-hearing briefing are, one, whether [immediate jeopardy] was present; and, two, whether [immediate jeopardy] continued until [CMS found the facility returned to substantial compliance].”  Tr. at 274-75; see also CMS Posthrg. Br. at 1.  During the hearing, counsel for Petitioner did not object to or ask to correct opposing counsel’s statement.  Tr. at 274-75.  As I discuss in greater detail in section IV.B.2, below, it appears Petitioner is now attempting to retreat from this stipulation and to argue that CMS cited noncompliance under the wrong regulation.  See P. Posthrg. Br. at 2 n.1.   Further, Petitioner did not appeal deficiencies that CMS cited at the non-immediate jeopardy level of scope and severity.  See P. Posthrg Br. at 8 n.4.  Accordingly, the issues remaining for decision are:

1. Whether CMS’s determination that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety is clearly erroneous; if not
2. Whether Petitioner abated the immediate jeopardy earlier than CMS determined; and
3. Whether the per day CMP amounts are reasonable.

III. Jurisdiction

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

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IV. Discussion

A. Statutory and Regulatory Framework

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

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

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

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

In a hearing before an administrative law judge, CMS must make a prima facie case that the SNF failed to comply substantially with federal participation requirements.  If CMS makes a prima facie case, the burden of persuasion shifts to the SNF, which must prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB

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No. 1611 at 8 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health and Human Servs., No. 98-3789 (GEB) (D. N.J. May 13, 1999); see Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson,129 F. App’x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001).

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

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

Resident 126 To protect their privacy, I refer to residents involved by the resident numbers assigned during the surveys.  See CMS Ex. 34; see also CMS Ex. 1.

At the time of the events at issue, Resident 126 was a 78-year-old man who had been admitted to Petitioner’s facility on September 25, 2013. The facts concerning Resident 126 are largely undisputed.  The only truly disputed facts relate to the question of whether the actions of Petitioner’s staff in removing the side rails from Resident 126’s bed posed immediate jeopardy to Resident 126 or to Petitioner’s other residents.  I discuss this issue further in section IV.B.3, below.  See, e.g., CMS Ex. 8 at 1.  His diagnoses included dementia, atrial fibrillation, type 2 Diabetes, and anxiety, among others.  Id.; see also CMS Ex. 9 at 2.  Resident 126 was prescribed Coumadin (Warfarin), an anticoagulant, based on his diagnosis of atrial fibrillation.  CMS Ex. 9 at 2; see also CMS Ex. 8 at 4.  Upon admission to Petitioner’s facility, a physician ordered bilateral half side rails for Resident 126’s bed to aid him in turning and repositioning.  Id. at 2; see also CMS Ex. 7 at 15.  Resident 126’s Care Plan also noted that he was at risk for falls, had an unsteady gait, and needed assistance from staff for transfers.  CMS Ex. 7 at 1.

Sometime in May or June 2016, Petitioner’s staff completed a facility-wide assessment of side rail usage.  P. Ex. 7 at 3; see also CMS Ex. 4 at ¶ 17.  During this review, Petitioner determined that Resident 126’s side rails should not be removed, but that his roommate’s should.  CMS Ex. 1 at 25; P. Ex. 7 at 3-4; Tr. at 195-96.  On June 7, 2016, Petitioner issued a work order to maintenance staff to remove the side rails in Resident 126’s room, but the work order did not specify which resident’s bed.  CMS Ex. 35.  On June 8, 2016, based on instructions from one of Petitioner’s nursing staff, maintenance staff removed the side rails from the bed “nearer the door,” which was Resident 126’s bed.  P. Ex. 7 at 3; see also CMS Ex. 35.  Because of this error, Resident 126’s side rails were removed, rather than those of his roommate.  P. Ex. 7 at 3-4.

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Five days later, on June 13, 2016, at 11:15 p.m., Resident 126 fell from his bed and hit his head.  CMS Ex. 6 at 9.  On June 14, 2016, at 8:45 p.m., Resident 126 complained of dizziness and was sent to the emergency room.  Id. at 8.  A computed tomography (CT) scan revealed that Resident 126 sustained a right basilar ganglia parenchymal hematoma (brain bleed).  CMS Ex. 10 at 2.  The next day, June 15, 2016, a second CT scan showed an increase in the size of the hemorrhage.  Id. at 4.  On June 16, 2016, the hospital deemed Resident 126 appropriate for inpatient hospice care.  Id. at 5.  Three days later, on June 19, 2016, Resident 126 died.  CMS Ex. 12.

Petitioner’s Investigation/Corrective Action Plan

Following Resident 126’s hospitalization, Petitioner investigated his fall.  CMS Ex. 15 at 1‑2.  A “Five Day Follow-Up” Report, dated June 17, 2016, described the circumstances surrounding the fall as follows:

Res[ident] fell from bed on 6/13/16 resulting in transport to [hospital Emergency Department] on 6/14 and [diagnosis] of brain bleed.  Review of Prog[ress] Notes, side rail audit, work order history, physician’s orders, side rail assessment, and Res[ident] care plans identified a clerical error that resulted in the Resident’s side rails being removed instead of the Res[ident’s] Roommate’s.  The Nurse’s Note following the fall from bed indicates that the resident was attempting to sit up when he fell from the bed.

Id.

Petitioner implemented a corrective action plan which included recurring audits of physician’s orders and side rail assessments, education to staff regarding safe side rail use, the use of focus sheets A focus sheet is a written communication that Petitioner uses to direct care givers to provide residents with interventions, services, and equipment ordered by the residents’ physicians.  CMS Ex. 4 at ¶ 47. to identify which residents had orders for side rails, in-service education sessions, and coaching for specific staff members.  Id. at 4-6.  Among other subjects, Petitioner conducted in-service training to resident care staff on “Following the focus sheets that are [sic] preventions and equipment are in place.  Ensuring if side rails are indicated on the focus sheet that they are in place or if they are not on the focus sheet that they are not on the bed.”  Id. at 5; see also CMS Ex. 1 at 25 (per statement of administrator, plan of correction included ensuring “staff followed the focus sheets, which contained directives for safety preventions and equipment.”).

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State Agency Investigation

On July 7, 2016, the state agency received a complaint from Resident 126’s medical power of attorney.  CMS Ex. 11 at 1; see also CMS Ex. 4 at ¶ 31.  The state agency then conducted an annual survey and complaint investigation from October 4, 2016 through October 17, 2016.  CMS Ex. 1 at 1; CMS Ex. 2 at 1.

On October 5, 2016, as part of her investigation, the state agency surveyor, Ms. Monahan, conducted a “sweep” of resident rooms.  CMS Ex. 4 at ¶ 47.  The purpose of the sweep was to determine whether Petitioner was providing the assistive devices (such as fall mats, side rails, and bed alarms) called for in the residents’ focus sheets.  Id.  Ms. Monahan observed that Resident 48, who had a history of falls, and whose physician had ordered a bed alarm, had a bed alarm that did not function properly.  CMS Ex. 1 at 27-28; CMS Ex. 4 at ¶ 55; CMS Ex. 20 at 1.  Resident 44, who was also a fall risk and required a bed alarm, was found to not have an alarm in place.  CMS Ex. 1 at 28‑29; CMS Ex. 4 at ¶ 56; CMS Ex. 18 at 1; CMS Ex. 19 at 1.  Resident 102 had a history of falls and had orders for a bed alarm, but her bed alarm was not functioning.  CMS Ex. 1 at 29; CMS Ex. 4 at ¶ 57; CMS Ex. 26 at 1.  Resident 67, who was at risk for falls and had impaired mobility, required a bed alarm; however, Ms. Monahan observed his bed alarm hanging from the back of the bed and turned off; in addition, the pressure pad that should have been on the resident’s bed was missing.  CMS Ex. 1 at 29-30; CMS Ex. 4 at ¶ 58; CMS 22 at 1.

On October 6, 2016, the state agency notified Petitioner that the failure to follow Petitioner’s correction plan by ensuring that all physician-ordered safety equipment was in place resulted in a finding of immediate jeopardy.  CMS Ex. 31 at 1.  Petitioner submitted a plan of correction that same day, which the state agency accepted.  Id. at 1-2.  Based on the accepted plan of correction, the state agency found the immediate jeopardy was abated on October 6, 2016.  Id.; see also CMS Ex. 2 at 1.

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

The quality of care regulation, 42 C.F.R. § 483.25, states generally that “[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”  Subsection 483.25(h) imposes specific obligations upon a facility related to accident hazards and accidents, as follows:

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(h) Accidents.  The facility must ensure that—

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

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

Petitioner concedes that its actions represented a deficient practice.  Tr. at 273-75.  Petitioner does not dispute that its staff erred by removing the side rails from Resident 126’s bed nor that, after the side rails were removed, Resident 126 fell from bed and suffered serious injury.  Id. at 196; see also P. Posthrg. Br. at 1.

Despite having conceded that its actions represented a deficient practice, As I pointed out previously, I and opposing counsel understood Petitioner to have stipulated that it failed to comply substantially with 42 C.F.R. § 483.25(h).  See supra note 2. Petitioner nevertheless argues that CMS failed to make a prima facie case that its noncompliance was the cause of Resident 126’s fall from bed and the resulting injury that led to his death.  See, e.g., P. Posthrg. Br. at 2 n.1.  Petitioner’s argument is somewhat convoluted and, in any event, appears to be primarily intended to establish that removing the side rails from Resident 126’s bed did not pose immediate jeopardy to resident health or safety. In the following section of this decision, I explain why Petitioner’s argument regarding CMS’s burden of proof on the issue of immediate jeopardy is misplaced.   However, to the extent Petitioner now contends that CMS failed to make a prima facie case of noncompliance with 42 C.F.R § 483.25(h) because it did not establish that removing the side rails caused Resident 126’s fall from bed, I disagree.

To conclude that CMS has made a prima facie case of noncompliance with 42 C.F.R. § 483.25(h)(2), I must find evidence that Petitioner failed to provide a needed assistive device and that this failure had the potential to cause more than minimal harm to a resident.  Contrary to Petitioner’s suggestion (see P. Posthrg. Br. at 2 n.1), CMS need not prove that Petitioner’s error in removing Resident 126’s side rails was the sole cause of Resident 126’s fall.  Nor is CMS required to eliminate every other possible explanation for Resident 126’s fall.  To establish a prima facie case, a party need only produce “enough evidence to allow the fact-trier to infer the fact at issue and rule in the party’s favor.”  Black’s Law Dictionary at 1228 (8th ed. 2004) (cited in Hilltop Manor Health Care Ctr., DAB CR3052 at 5-7 (2013)).

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Petitioner acknowledges, even underscores, that Resident 126’s physician ordered side rails as an “assistance device” to help Resident 126 “turn and reposition in his bed.”  P. Posthrg. Br. at 3 (italics in original).  As already described, Petitioner concedes that its staff removed the side rails from Resident 126’s bed due to a “clerical error.”  Id. at 1.  As such, Petitioner admits that it failed to provide an assistive device that Resident 126’s physician had determined the resident needed.  If I can infer that this failure on Petitioner’s part had the potential for more than minimal harm, CMS has made a prima facie case of noncompliance.  I have no difficulty in drawing such an inference.

The state agency surveyor, Ms. Monahan, testified credibly that Resident 126’s side rails, prescribed by his physician as assistive devices for repositioning, would have an added benefit of helping him to reposition more safely by giving him added stability.  See, e.g., Tr. at 44, 63.  Accordingly, by removing the side rails, Petitioner deprived Resident 126 of an assistive device that could aid his stability, which could increase the risk that he would lose his balance and experience a fall, as in fact happened.  This posed a risk for more than minimal harm to Resident 126, particularly because he was prescribed anticoagulant therapy.  See CMS Ex. 4 at ¶ 44.  As such, any fall could cause him to experience bleeding.  Id.

Therefore, I find that CMS made a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h) (Tag F323).  Petitioner did not rebut this conclusion by a preponderance of the evidence.  Having concluded that Petitioner was not in substantial compliance, I next consider whether CMS’s finding of immediate jeopardy was clearly erroneous.

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

Immediate jeopardy exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  Petitioner argues that this definition places on CMS the burden to establish that a facility’s failure to comply with a participation requirement was the cause in fact of serious injury to a resident or that it was likely to cause such injury.  See, e.g., P. Posthrg. Br. at 2 (threshold inquiry in this case is “whether the mistaken removal of Resident #126’s side rails plausibly caused his accident (or was “likely to cause” a similar accident).” (italics in original)).  Petitioner’s argument on this point has been explicitly rejected in appellate decisions of the Departmental Appeals Board (DAB).

In Liberty Commons Nursing and Rehab Ctr. - Johnston, DAB No. 2031 at 18 (2006), aff’d Liberty Commons Nursing & Rehab Ctr.-Johnston v. Leavitt, 241 F. App’x 76 (4th

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Cir. 2007),  Petitioner’s counsel should be well aware of the Liberty Commons decision, since he represented the facility in that case. the facility argued – as does Petitioner in the present case – that the regulatory definition of immediate jeopardy “specifically requires CMS to allege and to demonstrate a causative link between some asserted noncompliance, and actual or ‘likely’ serious harm to one or more actual residents in order to support an immediate jeopardy finding.”  Id. (quoting the facility’s brief).  In rejecting this argument, the appellate panel explained:

[The facility] appears to be arguing either that CMS’s burden of producing evidence sufficient to make a prima facie case on the issue of noncompliance extends to the issue of the level of noncompliance – here immediate jeopardy – as well or that CMS has the burden of proof on the issue of immediate jeopardy.  Neither argument is legally supportable.

                                         *        *        *

Extending CMS’s prima facie case obligation to the issue of the level of noncompliance or allocating the burden of proof on that issue to CMS would be inconsistent with 42 C.F.R. § 498.60(c)(2), which limits the [administrative law judge’s] scope of review of CMS’s finding regarding the level of noncompliance.  Section 498.60(c)(2) states that CMS’s finding regarding the level of noncompliance “must be upheld unless it is clearly erroneous”.  The Board has held that this regulation places the burden on the SNF – a heavy burden, in fact – to upset CMS's finding regarding the level of noncompliance.  In other words, under section 498.60(c)(2), CMS’s finding regarding the level of noncompliance must be upheld absent a showing of clear error.  To require CMS to make a prima facie case on the level of noncompliance would effectively and impermissibly convert what is clearly a limitation on the [administrative law judge’s] scope of review under the regulations (and by extension a corresponding burden of proof on the SNF) into a burden of proof, or at least a burden of going forward, on CMS.

Id. (internal citations omitted).  In summary, the regulations do not place the burden of proving causation on CMS.

To the contrary, pursuant to 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.  See, e.g., Brian Ctr. Health and Rehab./Goldsboro, DAB No. 2336 at 9 (2010).  Once CMS presents evidence supporting a finding of noncompliance, CMS need not offer evidence to support its determination that the

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noncompliance constitutes immediate jeopardy.  See, e.g., Cal Turner Extended Care Pavilion, DAB No. 2384 at 14-15 (2011), rev’d on other grounds, Cal Turner Extended Care Pavilion v. U.S. Dep’t of Health & Human Servs., 501 F. App’x. 502 (6th Cir. 2012).  Rather, the burden is on the facility to show that the immediate jeopardy determination is clearly erroneous.  See id. at 14-15; see also Miss. Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), aff’d, Miss. Care Ctr. of Greenville v. U.S. Dep’t of Health & Human Servs., 517 F. App`x 209 (5th Cir. 2013).

Petitioner’s primary argument is that CMS’s determination of immediate jeopardy is clearly erroneous because there is no causal connection between the removal of Resident 126’s side rails and the fall that led to his subsequent death.  P. Br. at 7, 9.  For the reasons I have just explained, CMS is not required to prove a causal connection.  Moreover, the evidence Petitioner has offered is insufficient to disprove that such a connection existed.

Petitioner relies on the testimony of its administrator, Linda Dailey, for the proposition that side rails are intended to aid residents with bed mobility and are not intended as safety devices.  See P. Ex. 7 at 1-2.  However, Petitioner’s argument that, because Resident 126’s side rails were intended to aid him in repositioning, they could not have had a role in his fall is fatally flawed.  Even though I may agree that the primary purpose of side rails is to aid bed mobility, that does not prove that side rails have no role in promoting safety.  As I have described above, CMS’s witness, Ms. Monahan, testified that side rails assist residents in repositioning safely while in bed.  See, e.g., Tr. at 44, 63.  Ms. Monahan is a registered nurse with over 35 years of clinical nursing experience.  CMS Ex. 4 at ¶¶ 1, 3.  In Ms. Monahan’s opinion, the removal of Resident 126’s side rails contributed to his fall from bed.  Id. at ¶ 40; see also Tr. at 42-43, 63, 69, 76-77.  Petitioner’s administrator opined that the removal of Resident 126’s side rails did not contribute to his fall.  See, e.g., P. Ex. 7 at 2.  However, Ms. Dailey is not a medical professional; she acknowledged that she is not qualified to determine if a resident should have side rails, nor to write or discontinue orders.  Tr. at 178-79.

Further, Petitioner’s investigation report, which Ms. Dailey signed, highlights a connection between the removal of Resident 126’s side rails and his fall.  In the report, which was dated June 17, 2016, Ms. Dailey wrote:

Review of Prog[ress] Notes, side rail audit, work order history, physician’s orders, side rail assessment, and Res[ident] care plans identified a clerical error that resulted in the Resident’s side rails being removed instead of the Res[ident’s] Roommate’s.  The Nurse’s Note following the fall from bed indicates that the resident was attempting to sit up when he fell from the bed.

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CMS Ex. 15 at 1-2.  I find that Ms. Dailey’s written direct testimony is inconsistent with the report she prepared.  I accord more weight to the report because it was prepared contemporaneously (within four days after Resident 126 fell), and before the matter was the subject of litigation.  Further, Ms. Dailey’s report is consistent with the nursing note documenting Resident 126’s fall.  See CMS Ex. 6 at 9 (“res[ident’s] bed previously noted with side rails, side rails not present at this time.  [Resident] stated he rolled out of the bed when trying to sit up.”).

In addition, I accord less weight to Ms. Dailey’s testimony than to that of Ms. Monahan.  Ms. Monahan’s experience and training as a registered nurse qualifies her to opine on matters involving nursing care, while Ms. Dailey’s experience as a nursing home administrator does not.  For all these reasons, I conclude that Petitioner’s evidence is insufficient to establish that CMS’s finding of immediate jeopardy was clearly erroneous.  I next consider whether CMS’s determination of the duration of immediate jeopardy was clearly erroneous.

4. Petitioner failed to prove that CMS clearly erred in concluding that immediate jeopardy continued through October 5, 2016.

Regarding the duration of noncompliance, “the period of noncompliance continues until the facility affirmatively demonstrates a return to substantial compliance.”  Ridgecrest Healthcare Ctr., DAB No. 2493 at 15 (2013) (citing Premier Living & Rehab. Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care, DAB No. 1658 at 12-15 (1998)); see also W. Tex. LTC Partners, Inc., DAB No. 2652 at 18 (2015) (facility “has the substantive burden of proving that it achieved substantial compliance earlier than the date CMS determined.”).  The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist.  Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12-13 (2011).  To demonstrate a return to substantial compliance, the facility must show that the incidents of noncompliance have ceased and that it has implemented appropriate measures to ensure that similar incidents will not recur.  Libertywood Nursing Ctr., DAB No. 2433 at 15 (2011) (citing Life Care Ctr. of Elizabethton, DAB No. 2367 at 16 (2011)); accord 42 C.F.R. § 488.456(a) and (e).  A facility’s return to substantial compliance usually must be established through a resurvey.  42 C.F.R. § 488.454(a); Ridgecrest, DAB 2493 at 2-3.

Moreover, CMS’s determination that noncompliance continues to pose immediate jeopardy to a facility’s residents “constitutes a determination about the ‘level of noncompliance’ and, therefore, is subject to the clearly erroneous standard of review under section 498.60(c)(2).”  Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336 at 7‑8.  Thus, CMS’s finding as to the duration of immediate jeopardy is presumed to be correct, and Petitioner must demonstrate clear error to establish that it removed the immediate jeopardy earlier than CMS found.  Id. at 9 (and cases there cited).

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Petitioner argues that, even if it was not compliant with 42 C.F.R. § 483.25(h), the “alleged deficiencies in the later survey are not related [to Resident 126’s accident] and therefore cannot extend to continuing noncompliance.”  P. Br. at 2.  Petitioner further argues that even if Resident 126’s fall constituted immediate jeopardy, Petitioner “promptly addressed” and responded to the matter, thereby abating immediate jeopardy.  Id. at 10.  Neither argument proves that CMS clearly erred in concluding that Petitioner’s noncompliance continued to pose immediate jeopardy through October 5, 2016. 

As to Petitioner’s first argument, I observe that Petitioner does not dispute that, at the time of the survey, some of its residents lacked bed alarms (or working bed alarms) that had been ordered by their physicians.  Instead, Petitioner argues that the failure to ensure that working bed alarms were present did not pose a risk of serious harm to its residents and, in any event, was unrelated to the removal of Resident 126’s side rails and, therefore, could not provide a basis for citing the facility with continuing noncompliance.  I disagree.

First of all, I disagree that the purpose of bed alarms is completely unrelated to the purpose of side rails, as Petitioner suggests.  Rather, bed alarms are intended to help keep residents safe while they are in bed, as Petitioner acknowledges.  See P. Posthrg. Br. at 16-17 (“[T]he notion is generally accepted . . . that at least in some cases the [bed alarm] sound can alert staff (or the resident herself) that a resident is moving in a potentially risky manner.”).  Similarly, Petitioner acknowledges that side rails are assistance devices that help residents turn and reposition in bed.  P. Posthrg. Br. at 3.  And, as I have described above, the surveyor’s unrebutted testimony establishes that side rails assist residents to turn and reposition safely.  See, e.g., Tr. at 44, 63.  Thus, both side rails and bed alarms serve the related purpose of enhancing residents’ safety while in bed.

However, even if I were to conclude that bed alarms and side rails did not serve somewhat similar purposes, I would not find that CMS’s finding as to the duration of immediate jeopardy was clearly erroneous.  Resident 126, who was assessed as a fall risk, experienced a fall from bed causing him serious injury that ultimately led to his death.  As I have described above, Petitioner’s own investigation concluded that its error in removing Resident 126’s side rails was a factor in the accident.  Thus, Resident 126 fell from bed at least in part because Petitioner’s staff failed to ensure that he received assistive devices (side rails) that his physician had ordered, thereby failing to comply substantially with 42 C.F.R. § 483.25(h).  As relevant here, section 483.25(h) requires SNFs to ensure that “[e]ach resident receives adequate supervision and assistance devices to prevent accidents.”  The regulation does not define or limit the devices that must be provided.  Petitioner cites to no authority for the proposition that a deficiency for failing to provide assistive devices to prevent accidents does not continue unless the same assistive device or devices are at issue.  Nor would I expect any such authority to exist.  Simple common sense dictates that, if a facility fails to provide one type of assistive

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device today, it does not achieve compliance with its regulatory obligation if it fails to provide a different type of assistive device tomorrow.

Moreover, it was reasonable for the state agency surveyor to verify whether Petitioner had achieved substantial compliance by investigating whether Petitioner had successfully implemented the correction plan it established following Resident 126’s fall.  A facility’s correction plan “may be regarded as evidence of the measures necessary to bring the [facility] back into substantial compliance.”  Libertyville Manor Rehab. & Healthcare Ctr., DAB No. 2849 at 14 (2018).

Following Resident 126’s fall in June 2016, Petitioner implemented a correction plan that included an audit of physician’s orders and side rail assessments, and education to staff regarding focus sheets, side rail use, and post fall procedures.  CMS Ex. 15 at 1-3.  As part of this corrective action plan, Petitioner conducted in-service training for its resident care staff, among other things.  One aspect of Petitioner’s in-service training was “Following the focus sheets that are [sic] preventions and equipment are in place.”  CMS Ex. 15 at 5.  During the survey, Ms. Monahan observed that, of seventeen residents who had physician orders for bed alarms that were recorded on their focus sheets, four either had no bed alarm or had bed alarms that did not function properly.  CMS Ex. 4 at ¶ 59.  Based on the surveyor’s observations, it was not clearly erroneous for CMS to conclude that immediate jeopardy continued until Petitioner addressed its continuing failure to ensure that each resident was actually furnished the assistive devices his or her physician had ordered.

Petitioner argues that the administrative law judge’s decision in The Springs at the Watermark, DAB CR5064 (2018) supports its position that CMS cannot cite continuing noncompliance based on “allegations of noncompliance – or even suggestions of hypothetical scenarios – that are unrelated to the actual basis for the cited noncompliance.”  P. Posthrg. Br. at 7.  The Watermark decision does not address the issue at all.  Instead, in Watermark,the administrative law judge reduced the duration of immediate jeopardy because he found that the facility in that case promptly implemented corrective actions that were effective in protecting residents from eloping.  DAB CR5064 at 7-9.  Although CMS apparently concluded that additional corrective measures were required, the administrative law judge determined that the additional measures were not reasonable.  Id. at 7.  Moreover, the judge explicitly considered the extent to which the facility had implemented its corrective action plan to prevent elopements.  Id. at 6.

In contrast to the facility in Watermark, in the present case, Petitioner did not prove that it promptly and completely addressed all the issues revealed by Resident 126’s accident.  Resident 126’s fall revealed that Petitioner’s staff had overlooked that Resident 126 did not have an assistance device that his physician had ordered (in his case, side rails).  Petitioner did conduct an audit to make sure that its residents who had orders for side rails had them installed and that residents who did not have orders for side rails did not

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have them installed.  However, Petitioner’s audit did not succeed in ensuring that all of its residents received all assistive devices ordered by their physicians, as I have just described.  Where, as here, the facility’s corrective measures did not eliminate the likelihood of serious harm, there is no basis to shorten the period of immediate jeopardy.

For these reasons, I find that Petitioner has not shown that CMS’s determination as to the duration of immediate jeopardy was clearly erroneous.

5. A CMP of $12,341 per day for the period of immediate jeopardy is reasonable.

I have concluded that Petitioner failed to comply substantially with 42 C.F.R. § 483.25(h) and that CMS did not clearly err in determining that Petitioner’s noncompliance posed immediate jeopardy to Petitioner’s residents from June 8, 2016 through October 5, 2016.

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

The regulations specify that a per day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  CMS imposes a CMP in the upper range, $6,291 to $20,628 per day, for deficiencies that pose immediate jeopardy to a facility’s residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2). 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 81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).  CMS imposes a CMP in the lower range, $103 to $6,188 per day, for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii).  In assessing the reasonableness of a CMP amount, an administrative law judge considers the per day amount, rather than the total accrued CMP.  See Kenton Healthcare, LLC,DAB No. 2186 at 28 (2008).  The regulations leave

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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.

CMS decided to impose per day CMPs in this case, and I have found that the declaration of immediate jeopardy was not clearly erroneous.  For the period of Petitioner’s immediate jeopardy level noncompliance (June 8, 2016, through October 5, 2016), CMS imposed a CMP of $12,341 per day, which is near the midpoint of the range for immediate jeopardy level noncompliance.  For the period of Petitioner’s non-immediate jeopardy level noncompliance (October 6, 2016, through December 13, 2016) CMS imposed a per day CMP of $403, which is at the lower end of the range for non-immediate jeopardy level noncompliance.  Petitioner did not request review of the non-immediate jeopardy level deficiencies in this proceeding.  See P. Posthrg Br. at 8 n.4.  I therefore summarily affirm the amount and duration of the $403 per day CMP imposed for the non-immediate jeopardy level noncompliance.

Petitioner does not argue that any particular regulatory factor supports a reduction of the CMP amount proposed by CMS.  For that reason alone, I could conclude the CMP amount is reasonable.  See Coquina Ctr., DAB No. 1860 at 32.  However, I have reviewed the regulatory factors and explain why I find that they support a conclusion that the CMP amount is reasonable in relation to Petitioner’s immediate jeopardy level noncompliance.

As I have described above, Petitioner’s failure to ensure that its staff provided Resident 126 the assistive devices ordered by his physician (side rails) contributed to an accident that ultimately led to Resident 126’s death.  As such, the noncompliance represented immediate jeopardy.  Although the record does not reveal that any resident other than Resident 126 experienced a fall or other accident related to Petitioner’s failure to provide assistive devices, there can be no doubt that Petitioner’s elderly and frail residents would risk serious injury if they experienced falls.  See, e.g., CMS Ex. 4 at ¶ 43.  Further, although Resident 126’s accident revealed that Petitioner’s staff were not being proactive in ensuring that residents received all assistive devices noted in focus sheets, physician orders, or care plans, Petitioner had not resolved this issue at the time of the survey.  These facts reveal the seriousness of Petitioner’s noncompliance.  The facts also demonstrate that Petitioner was culpable for the failure that led to Resident 126’s fall.  Under the regulation, culpability includes neglect or indifference.  Here, Petitioner’s carelessness in removing Resident 126’s side rails and failing to discover the mistake until after Resident 126 fell is evidence of neglect or indifference.  CMS imposed a CMP

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of $12,341 per day, which is near the middle of the immediate jeopardy range.  The regulatory factors of seriousness and culpability fully support the CMP amount.

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

V. Conclusion

For the reasons discussed above, I conclude that Petitioner was not in substantial compliance with the Medicare participation requirements at issue.  Moreover, Petitioner did not establish that CMS’s immediate jeopardy determination was clearly erroneous.  Nor did Petitioner prove that it abated immediate jeopardy earlier than October 6, 2016.  Accordingly, I conclude that CMS had a basis to impose a CMP.  Finally, I conclude that the CMPs imposed are reasonable.