Artesian Home Center, DAB CR6744 (2025)

DECISION

Artesian Home Center (Petitioner or facility) is a skilled nursing facility (SNF) that participates in the Medicare program.

Over a period of approximately four months, three of Petitioner’s residents fell a total of 15 times at the facility.  One resident, R41, was elderly and severely cognitively impaired, and continually wanted to get up and walk in the facility even though it was unsafe for her do so unassisted.  The facility failed to provide increased supervision, as required by R41’s plan of care.  R41 fell six times within seven weeks, fracturing her hip and arm.  Another resident, R28, an extremely elderly woman with moderate cognitive impairment, was at the facility to recover from a fracture caused by a fall at home.  The facility did not immediately assess R28 or create a care plan.  Within four days, R28 fell while going outside the facility to smoke.  Although Petitioner rushed to put a care plan into place, R28 fell twice more, once inside the facility and once outside while smoking.  The latter fall resulted in a trip to the emergency room (ER).  As a result, the facility started to supervise R28 when she went outside to smoke, but did not supervise her movements within the facility.  R28 then fell three more times within the facility, for a total of six falls in a three-month period.  The final resident, R34, was not elderly and not cognitively impaired, but she had lost one of her legs beneath the knee and was obese.

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This made independent transfers from her bed to a wheelchair difficult.  After an initial fall while attempting an independent transfer, R34’s physician ordered a slide board as an assistive device.  However, the facility did not provide it to her.  Months later, R34 fell twice trying to independently transfer between her wheelchair and bed.  The facility responded by providing a different assistive device ordered by a nurse practitioner.  R34 fell again while independently transferring.  R34’s three falls, which occurred after the physician ordered the slide board, happened within a month’s time.

Near the end of the time period when R28, R34, and R41 were experiencing falls, another resident, R94, was admitted to the facility.  R94 had no trouble with walking but instead was at risk while eating.  He had no teeth, was severely cognitively impaired, and had a physician order and care plan that required his food to be mechanically softened before he ate it.  Although Petitioner assessed R94 as needing staff assistance with almost all activities of daily living, the facility thought he could independently eat.  Staff noted that R94 “shoveled” food into his mouth at meals.  Just over two weeks after being admitted, R94 began to choke while eating a meal.  Staff were able to remove enough pieces of scalloped potatoes from his airway so he could breathe, but R94 still had an airway partially obstructed with potatoes.  The Emergency Medical Service (EMS) whisked R94 to the ER, which in turn diagnosed him with aspirational pneumonia and sent him to a hospital’s intensive care unit (ICU).  After five days in the hospital, R94 returned to the facility, where the facility commenced supervising his eating and, as stated in the report concerning the choking incident, making sure R94’s meals met his dietary requirements (i.e., were mechanically softened).

Based on an Oklahoma State Department of Health (state agency) survey of Petitioner’s facility, the Centers for Medicare & Medicaid Services (CMS) found that Petitioner had not been in substantial compliance with the Medicare program requirements to 1) adequately supervise residents and provide assistive devices to prevent accidents, and 2) provide food that meets the individual needs of residents.  CMS also determined that Petitioner’s noncompliance immediately jeopardized the health and safety of residents.  CMS imposed a remedial per-day civil money penalty (CMP) on Petitioner for 23 days.  The CMP amount was $14,300 per day for the first four days, until Petitioner abated the immediate jeopardy situation, and then $1,300 per day until Petitioner returned to substantial compliance with Medicare program requirements.

Petitioner requested a hearing to dispute CMS’s findings of substantial noncompliance  that caused an immediate jeopardy situation.  After holding a hearing and considering the record in this case, I conclude that Petitioner was noncompliant with Medicare program requirements at 42 C.F.R. §§ 483.25(d)(2) and 483.60(d)(3), and that CMS’s immediate jeopardy determination was not clearly erroneous.  Further, Petitioner did not challenge the amount and duration of the CMP; therefore, I uphold the imposition of that remedy.

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I.     Legal Framework

The Medicare program “provides basic protection against the costs of . . . related post-hospital . . . care” for individuals over the age of 65 who are eligible for Social Security retirement benefits and for individuals under the age of 65 who meet other criteria.  42 U.S.C. § 1395c.  Post-hospital care includes extended care services provided at an SNF.  42 U.S.C. §§ 1395f(a)(2)(B), 1395x(h)-(i).

For Medicare program purposes, an SNF is an institution that is primarily engaged in providing skilled nursing care and/or rehabilitation services for its residents but is not primarily engaged in the care and treatment of mental diseases.  42 U.S.C. §§ 1395x(j), 1395i-3(a)(1).  Because an SNF is a “provider of services” in the Medicare program, each SNF that participates in the program must file a provider agreement with the Secretary of Health and Human Services (Secretary).  42 U.S.C. §§ 1395cc(a), 1395x(u).

A Medicare participating SNF must meet a variety of ongoing statutory requirements as to how it provides services, maintains the rights of its residents, and administers its facility.  42 U.S.C. § 1395i-3(a)(3), (b)-(d).1  Further, SNFs must comply with “such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”  42 U.S.C. § 1395i-

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(d)(4)(B); see 42 U.S.C. § 1395i-3(c)(1)(xi), (f).  The Secretary has promulgated regulations to establish those additional requirements.  See 42 C.F.R. pt. 483, subpt. B.2

When an SNF fails to meet a statutory or regulatory participation requirement, then the SNF has a “deficiency.”  42 C.F.R. § 488.301; see also 42 U.S.C. § 1395i-3(h)(1).  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  42 C.F.R. § 488.301; see also 42 U.S.C. § 1395i-3(h)(3).  To maintain “substantial compliance,” an SNF’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.

“It is the duty and responsibility of the Secretary to assure that requirements which govern the provision of care in skilled nursing facilities . . . are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public monies.”  42 U.S.C. § 1395i-3(f)(1).  To do so, the Secretary contracts with state agencies to survey participating SNFs.  42 U.S.C. §§ 1395aa(a), 1395i-3(g); 42 C.F.R. § 488.10.  Standard surveys are unannounced and occur at least once every 15 months.  42 U.S.C. § 1395i-3(g)(2)(A)(i), (iii)(I).  State agencies also investigate complaints made against SNFs.  42 U.S.C. § 1395i-3(g)(1)(C), (4).

When the results of a survey or investigation show that an SNF is not in substantial compliance with Medicare program participation requirements, the Secretary may impose remedies on the SNF.  42 U.S.C. § 1395i-3(h)(2); 42 C.F.R. § 488.406.  All remedies imposed on SNFs are remedial in nature because they “ensure prompt compliance with [Medicare] program requirements” and “are applied on the basis of noncompliance found during surveys conducted by CMS or by the survey agency.”3  42 C.F.R. § 488.402(a)-(b); NMS Healthcare of Hagerstown, DAB No. 2603 at 8 n.6 (2014) (holding that, although the regulations use the term “civil money penalty,” the regulations also “make it clear that a CMP is not a punitive mechanism.”).  In order to assist a facility in returning to substantial compliance quickly, SNFs must file a plan of correction with the state agency/CMS.  42 C.F.R. § 488.402(d).

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When CMS selects a remedy to impose on an SNF, it determines the scope (i.e., the number of residents affected or potentially affected) and severity (i.e., the degree of harm or potential harm) for each deficiency.  See 42 C.F.R. § 488.404(a)-(b).  The highest level of severity occurs when the noncompliance immediately jeopardizes the health or safety of SNF residents.  See 42 U.S.C. § 1395i-3(h)(1).  “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.

One enforcement remedy is a CMP.  42 U.S.C. § 1395i-3(h)(2)(B)(ii).  CMS may impose a per‑instance CMP for each instance of the SNF’s noncompliance or a per‑day CMP for the number of days an SNF is not in substantial compliance.  42 U.S.C. § 1395i‑3(h)(2)(A), (h)(2)(B)(ii)(I); 42 C.F.R. § 488.430(a).  For CMPs assessed on or after January 17, 2020, and for deficiencies that occurred after November 2, 2015, the CMP amounts may range as follows:  $2,233 to $22,320 for per-instance CMPs; $112 to $6,695 per day for less serious noncompliance; or $6,808 to $22,320 per day for noncompliance that poses immediate jeopardy to the health and safety of residents.  45 C.F.R. § 102.3 (2020); 85 Fed. Reg. 2869, 2870, 2880 (Jan. 17, 2020); see also 42 C.F.R. § 488.438(a) (providing original CMP amounts before statutory inflation adjustments).

If CMS imposes a CMP based on a finding of noncompliance, then the SNF may request a hearing before an administrative law judge (ALJ) to challenge CMS’s initial determination of noncompliance that led to the imposition of an enforcement remedy and/or the level of noncompliance if a successful challenge to the level would affect the range of CMP amounts imposed on the SNF.  42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii); 42 C.F.R. §§ 488.330(e)(3)(ii), 488.408(g)(1), 488.434(a)(2)(viii), 498.3(b)(13)-(14), (d)(10); see also 5 U.S.C. §§ 554, 556.  However, CMS’s choice of remedies is not reviewable.  42 C.F.R. §§ 488.438(e)(2), 488.408(g)(2), 498.3(b)(13).

If an SNF challenges the existence of a deficiency, CMS must make a prima facie case that the SNF failed to substantially comply with federal participation requirements and, if such a showing is made, the SNF must then prove substantial compliance by a preponderance of the evidence.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health and Human Servs., No. Civ.A. 98-3789 (GEB), 1999 WL 34813783 (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).  If an SNF challenges CMS’s determination as to the level of noncompliance, CMS’s determination must be upheld unless it is clearly erroneous.  42 C.F.R. § 498.60(c)(2).

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If an ALJ concludes that there was a basis for imposing a CMP on an SNF, then the SNF may dispute the amount of the CMP.  The ALJ’s review of the CMP amount is limited to considering the statutory and regulatory factors for setting the CMP amount.  42 C.F.R. § 488.438(e)(3); see 42 U.S.C. §§ 1320a-7a(d), 1395i-3(h)(2)(B)(ii)(I); 42 C.F.R. § 488.438(f).  The ALJ may not reduce a CMP to zero.  42 C.F.R. § 488.438(e)(1).

Either the SNF or CMS may request that the Departmental Appeals Board (DAB) review an ALJ’s decision.  42 C.F.R. § 498.80; 5 U.S.C. § 557.

II.     Background and Procedural History

Petitioner is an SNF located in Sulphur, Oklahoma.  On February 10 through 12 and 18 through 20, 2020, the Oklahoma State Department of Health (state agency) conducted a recertification and licensure survey along with a complaint investigation.  CMS Ex. 2 at 1.  Based on the survey, the state agency documented numerous deficiencies in two Statements of Deficiencies (SOD).  CMS Ex. 2; CMS Ex. 26 at 2-5.  The state agency found that the following deficiencies immediately jeopardized the health and safety of residents:

• 42 C.F.R. § 483.25(d)(1), (2) (F-Tag 689) (S/S = K) (Accidents).
• 42 C.F.R. § 483.60(d)(3) (F-Tag 805) (S/S = J) (Food in Form to Meet Individual Needs).

CMS Ex. 2 at 19-37, 53-59.  The state agency also concluded that the facility removed the immediate jeopardy situation on February 20, 2020.  CMS Ex. 2 at 20-21, 54-55.

On November 19, 2020, CMS issued an initial determination imposing a CMP on Petitioner.  CMS Ex. 1.  CMS indicated that, although the immediate jeopardy conditions were removed by the end of the survey, Petitioner remained non-compliant with Medicare participation requirements until March 11, 2020.  CMS Ex. 1 at 1-2.  Therefore, CMS imposed a $14,300 per-day CMP for four days, from February 17, 2020 through February 20, 2020, and a $1,300 per-day CMP for 19 days, from February 21, 2020 through March 10, 2020, for a total CMP of $81,900.  CMS Ex. 1 at 1-2.

On January 12, 2021, Petitioner requested a hearing to dispute the findings of noncompliance and immediate jeopardy, and the imposition of a CMP.  The Civil Remedies Division acknowledged receipt of Petitioner’s hearing request and issued my Standing Prehearing Order.  On April 14, 2021, CMS filed a prehearing brief and 26 proposed exhibits, three of which were written direct testimony from witnesses (CMS Exs. 23-25).  On May 19, 2021, Petitioner submitted a prehearing brief and 38 proposed exhibits, eight of which were written direct testimony from witnesses (P. Exs. 31-38).  The parties requested to cross-examine all of the opposing party’s witnesses.

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On March 10, 2022, I issued a notice that I would hold a hearing on June 13 through 15, 2022.  In the notice, I admitted all of the parties’ proposed exhibits, without objection.

On April 8, 2022, CMS withdrew the written direct testimony for one of its witnesses (CMS Ex. 25) and withdrew its request to cross-examine three of Petitioner’s witnesses.  Also on April 8, 2022, CMS requested that I issue a subpoena to compel the attendance of CMS’s two remaining witnesses, Michelle Rawson (CMS Ex. 24) and Shonda Benedict (CMS Ex. 23).  These witnesses were originally state agency surveyors but had been hired by a business entity that owns Petitioner.  CMS stated that Petitioner’s counsel had not indicated that he would cooperate in ensuring that Ms. Rawson and Ms. Benedict would appear for the hearing.

On April 20, 2022, I directed Petitioner to respond to the subpoena request and confirm whether Ms. Rawson and Ms. Benedict were employees of Petitioner’s parent corporation.  I also directed Petitioner to state whether it believed that a subpoena would be necessary to compel the attendance of the witnesses.  Petitioner responded that Ms. Rawson and Ms. Benedict were now employed by Elmbrook Management, which operates and/or provides management services to numerous nursing facilities and assisted living facilities, including Petitioner.  Petitioner also stated that Ms. Rawson and Ms. Benedict informed Elmbrook’s chief executive officer that CMS contacted them about appearing for the hearing and that they were uncomfortable at the prospect of testifying.  Petitioner stated that it did not object to CMS’s subpoena request because the witnesses’ discomfort was an insufficient reason to object.  However, Petitioner stated that Elmbrook’s management would not require the witnesses to appear.

On April 21, 2022, I ordered Petitioner to provide additional information concerning the relationship between Petitioner and Elmbrook.  Petitioner responded that an individual named Thomas Coble is the sole owner of a number of entities.  Petitioner is owned by Artesian Home, Inc., which is wholly owned by one of Mr. Coble’s entities.  Ms. Rawson and Ms. Benedict were employed by different entities, but both entities were owned by Mr. Coble.  Petitioner’s counsel stated that he serves as counsel to various businesses owned by Mr. Coble on an ongoing basis.

On May 9, 2022, I issued an Order Denying CMS’s Motion for Issuance of a Subpoena (May 9 Order) because it did not comply with the regulations governing subpoenas.  I acknowledged that CMS no longer has the ability to require the witnesses, through the state agency for which they used to work, to appear for the hearing.  However, I reasoned that Thomas Coble, the owner of Petitioner and the business entities that employ the witnesses, could direct his own employees to appear and be cross-examined at the hearing.  I stated that Petitioner did not show that Mr. Coble was unable to direct his employees to appear at the hearing and merely preferred not to direct them.  I surmised that Mr. Coble may be using this situation to aid Petitioner in seeking the exclusion of the former surveyors’ written direct testimony.  I stated that the scheduling of the hearing

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provides Petitioner with an opportunity to cross-examine the former surveyors because Petitioner’s owner has the ability to direct the appearance of the former surveyors at the hearing.  Finally, I stated that I would accommodate the witnesses’ schedules and that they could appear at any time during the scheduled three-day hearing.

On June 13, 2022, I held an evidentiary hearing by video teleconference in this case.  CMS waived cross-examination of all of Petitioner’s witnesses except for Petitioner’s former Director of Nursing (DON), Rosalind Renee’ Smith, R.N.4  Hearing Transcript (Tr.) 12.  At the hearing, I excluded CMS Exhibit 25, which CMS had withdrawn before the hearing.  Tr. 6-7.  Neither of the two former state agency surveyors appeared for the hearing.  Petitioner’s counsel stated that they had a “strong preference not to participate on behalf of CMS, and Mr. Coble has told us them that he will not force them to do so.  And so, given that they are not available to CMS, and not available to Your Honor, the usual rule requests that their testimony also be withdrawn at this point.”  Tr. 7.  I provided Petitioner with the opportunity to raise the issue in post-hearing briefing.  Tr. 9-10.  After DON Smith testified, I discussed a post-hearing briefing schedule and advised the parties that all of the arguments that they wanted me to consider when rendering this decision had to be included in the post-hearing brief.  Tr. 89; July 15, 2022 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule at 1.

Both parties timely filed post-hearing briefs (CMS Br. and P. Br., respectively) and CMS filed a reply brief (CMS Reply).

In July 2024, Petitioner moved for remand of this case with an order for CMS to repay Petitioner the money it collected for the CMP and placed in escrow.  CMS filed an opposition to the motion.

III.     Rulings

In this proceeding, Petitioner asserts that it has the right to a jury trial based on Securities and Exchange Commission v. Jarkesy, 144 S. Ct. 2117 (2024), and requests that I remand this case to CMS with instructions for CMS to refund the CMP collected by CMS and placed in escrow.  The DAB recently denied similar motions for remand and refund.  Oak Ridge Ctr., DAB No. 3195 at 31-32 (2025); The Oaks, DAB No. 3160 at 27-28 (2024).

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As stated earlier, Petitioner has the right to dispute the imposition of the CMP in this case at a formal administrative proceeding before an ALJ.  5 U.S.C. §§ 554, 556-557; 42 U.S.C. §§ 1320a-7a(c)(2), 1395i‑3(h)(2)(B)(ii).  Therefore, I deny Petitioner’s motion and issue this decision under the authority of the duly enacted statutes cited above.

In its post-hearing brief, Petitioner renewed its motion to exclude the written direct testimony for Ms. Benedict and Ms. Rawson.  Petitioner asserted that CMS did not produce those witnesses for cross-examination but still wants their testimony to be admitted into the record.  P. Br. at 5.  Petitioner argued that my Standing Prehearing Order states that it is the responsibility of the party who offers written direct testimony to produce the witness for cross-examination.  P. Br. at 5.  Petitioner acknowledges that both former surveyors now work for entities owned by Thomas Coble, who also owns Petitioner.  P. Br. at 6.  Petitioner stated that the former surveyors would not willingly appear at a hearing and Mr. Coble would not require them to appear.  P. Br. at 6-7.  Petitioner also argued that the Federal Rules of Evidence address unavailable witnesses, and those rules would not support admission of the written direct testimony in this case.  P. Br. at 7-8.  Petitioner also stated there is no reason why Petitioner or Mr. Coble has any legal or practical responsibility to help CMS support its case by producing the surveyors as witnesses.  P. Br. at 8.  CMS responded to Petitioner that I had ordered Petitioner to produce the former surveyors at the hearing because they were now employees of Petitioner’s owner, but Petitioner declined to produce those witnesses.  CMS Reply at 2-3.

Petitioner’s arguments do not persuade me that my May 9 Order requiring Petitioner’s owner to direct his employees to appear at the hearing in this case was wrong.  Petitioner wants me to ignore that its owner has control over CMS’s witnesses.  In fact, Petitioner’s counsel even served as a conduit for communication between CMS and its witnesses.  April 8, 2022 CMS’s Mot. for Issuance of a Subpoena at 1; P. Resp. to CMS’s Req. for Subpoena at 2.  As a result, it is unclear what the true wishes of CMS’s witnesses were.

Petitioner has never specified any impediment, legal or otherwise, that Petitioner’s owner had to simply directing his employees to appear for a hearing and testify truthfully.  Rather, Petitioner’s owner is unwilling to do so.  This led me to question his motives.  As it turns out, Petitioner’s owner chose not to have his employees appear at the hearing to testify, and Petitioner’s counsel immediately moved to exclude their written direct testimony at the hearing.  Tr. 7.

I continue to find the following analysis in my May 9 Order to be correct:

Regardless, it is significant that when written direct testimony has been submitted, the opposing party only has to be given the “opportunity” to cross-examine the witness.  Vandalia Park, DAB No. 1940 (2004); Civil Remedies Division

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Procedures § 16(b) (“An ALJ may order that the written direct examination of a proposed witness be filed as a proposed exhibit with the party’s prehearing exchange.  A party will then be afforded an opportunity to cross-examine a witness during an oral hearing.).  In a situation like the one presented in this case, such an opportunity does not mean the party who submitted the written direct testimony must produce the witness for cross-examination or for an administrative law judge to issue a subpoena to compel the attendance of the witness.  Rather, scheduling of the hearing in this case at which Petitioner may cross-examine the former surveyors is sufficient opportunity since Petitioner’s owner may direct those former surveyors to appear for the hearing.

May 9 Order at 8.  CMS and I both offered to accommodate the schedules of these witnesses by allowing them to appear at any time during the three days originally planned for the hearing.  May 9 Order at 9.  Petitioner declined this opportunity to cross-examine the former surveyors.  As a result, I deny Petitioner’s motion to exclude CMS Exhibits 23 and 24.

I note that, for purposes of this decision, it does not matter whether I admit or exclude the testimony of the former surveyors.  I have not cited their testimony or the SOD as substantive evidence in this decision.  Therefore, none of my findings or conclusions are based on their testimony.  See Rehab at River’s Edge, DAB No. 3163 at 12 (2024) (“We reject Petitioner’s claim that the ALJ improperly relied on the testimony of CMS witnesses without allowing Petitioner to cross-examine them, because the ALJ demonstrably did not rely on testimony from any CMS witness to resolve any material factual dispute. . . . The ALJ did not even cite to the Statement of Deficiencies generated from the work of the State Agency surveyor.  As discussed below, the ALJ resolved the disputed issues in CMS’s favor by relying instead on other, ample non-testimonial exhibits, many of which were Petitioner’s own records turned over to the State Agency during the survey.”).

IV.     Issues

1) Whether Petitioner was in substantial compliance with the Medicare program requirements for SNFs identified in the SOD.

2) If Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.25(d)(2) and/or 483.60(d)(3), whether CMS’s immediate jeopardy determination was clearly erroneous.

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3) If Petitioner was not in substantial compliance with Medicare program requirements, whether a $14,300 per-day CMP for four days, from February 17, 2020 through February 20, 2020, and a $1,300 per-day CMP for 19 days, from February 21, 2020 through March 10, 2020, are reasonable.

V.     Findings of Fact and Conclusions of Law

My findings of fact and conclusions of law are in bold and italics.

Accident Prevention - 42 C.F.R. § 483.25(d)(2)

1. R41, an 80-year-old resident with profound cognitive deficits, had a care plan that identified a risk for falls.  Starting in late December 2019, R41 fell six times in just over six weeks.  One fall resulted in a fractured hip, which required surgical repair.  Following that fall, R41 was placed on hospice.  Another fall, a few weeks later, resulted in a fractured arm.  R41 died less than two weeks after that fall.  Although R41’s care plan included interventions for the risk of falls before R41 first fell in December 2019, Petitioner neither implemented all of those interventions nor added new interventions to the care plan to prevent future falls based on the evolving situation.  Petitioner’s staff knew that R41 would continue to attempt to walk unassisted, which placed R41 at significant risk for falling and injury.

R41 was an 80-year-old woman who was admitted to Petitioner’s facility in January 2018 with diagnoses that included the following:  dementia; osteoarthritis; combativeness; a history of falls with injury at home; and multiple other conditions that increased the risk of falls.  P. Ex. 32 ¶ 17.

Petitioner had a care plan for R41 for August 1, 2019 through February 19, 2020.  CMS Ex. 7 at 20-67.  There is a care plan entry for “Falls,” with a “Problem Start Date” of August 23, 2019.  CMS Ex. 7 at 48-49.  The long-term goal was for R41 to be “free from falls.”  CMS Ex. 7 at 48.  The target date for this goal was set for November 23, 2019.  The following care plan approaches/interventions had a “Problem Start Date” of August 23, 2019:  assess and treat for postural/orthostatic hypotension; implement an exercise program for strength, gait, and balance; increased staff supervision with intensity based on resident need; direct pharmacist to conduct comprehensive medication review to assess polypharmacy and medications that increase fall risk; and provide individualized toileting interventions.  CMS Ex. 7 at 49-50.

On November 12, 2019, Petitioner’s staff conducted a Minimum Data Set (MDS) assessment for R41.  CMS Ex. 7 at 1-7.  The Brief Interview for Mental Status (BIMS)

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showed that R41 received a 0 out of a possible score of 15, showing that R41 was severely cognitively impaired.  CMS Ex. 7 at 2.  Petitioner’s staff assessed R41’s Functional Status as independent and did not need physical help from staff to move in bed, transfer between surfaces (e.g., bed, chair, wheelchair, standing position), walk in room, walk in corridor, and locomote on and off R41’s unit.  CMS Ex. 7 at 5.  Similarly, staff assessed R41 as being steady at all times when moving from seated to standing position, walking, turning around, moving on and off toilet, and surface-to surface transfers.  CMS Ex. 7 at 6.  R41 did not need any mobility devices.  CMS Ex. 7 at 6.  R41 did not have any falls since admission to the facility.  CMS Ex. 7 at 7.

On November 13, 2019, Petitioner renewed the care plan entry detailed above from August 23, 2019, with the same approaches/interventions.  CMS Ex. 7 at 48-52.

On December 27, 2019, R41 fell.  A licensed practical nurse (LPN) reported that she was called to R41’s room and found R41 sitting on the floor next to her bed with blood on her face from two lacerations above and below her chin.  CMS Ex. 7 at 68, 150.  The fall was not witnessed by staff.  CMS Ex. 7 at 68.  R41 complained of moderate pain and was transported to a hospital’s ER for evaluation.  CMS Ex. 7 at 68, 150.  At the hospital, R41 had a facial bone CT scan, which was negative.  CMS Ex. 7 at 150.  R41 returned to Petitioner’s facility from the hospital later that day.  CMS Ex. 7 at 149.

Petitioner’s staff “closed” a review of the fall on December 31, 2019, and indicated that the “Falls Prevention Program” was not initiated, R41’s pain was resolved, the injury was healing without complication, and the care plan was updated.  CMS Ex. 7 at 68, 71.  The care plan update involved a new entry for “Psychosocial Well-Being,” with a “Problem Start Date” of December 27, 2019.  CMS Ex. 7 at 58.  The new entry specified that R41 had “an abrasion to her chin, bottom lip and a skin tear to left forearm due to fall.”  CMS Ex. 7 at 58.  The short-term goal was for the skin tear to heal within 30 days.  CMS Ex. 7 at 58.  The care plan approaches for this entry were to observe for signs and symptoms of infection, follow the treatment ordered by the physician, use good antiseptic technique, and conduct a weekly skin assessment.  CMS Ex. 7 at 58-59.  Significantly, the care plan was not updated to provide additional interventions to prevent falls.

R41 continued to walk throughout the facility alone.  On December 30 and 31, 2019, Petitioner’s staff noted R41 was ambulating in a hallway and common areas of the facility.  CMS Ex. 7 at 148-49.  On January 2, 2020, staff noted that R41 was going into the rooms of other residents and taking things from those rooms.  CMS Ex. 7 at 148.  On January 8, 2020, staff noted that R41 was following staff into the rooms of other residents and was trying to push other residents around in their wheelchairs.  CMS Ex. 7 at 147.

On January 10, 2020, R41 fell again.  An LPN reported that R41 fell in the main lobby of the facility, which was witnessed by staff.  CMS Ex. 7 at 89.  R41 complained of severe pain in her left hip.  CMS Ex. 7 at 89.  Staff indicated that they noted no injury but gave

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R41 analgesics for the pain.  CMS Ex. 7 at 89, 91.  Because the analgesics did not fully relieve R41’s pain, the facility called EMS, which transported R41 to a hospital ER.  CMS Ex. 7 at 91-92.

An Incident Report concerning the January 10, 2020 fall stated the following:

Staff report resident was resting on the couch in the main lobby.  Resident stood up to walk and fell on left side, resident assessed, left leg rotated outward and slightly shortened, complaint of hip pain. . . . [P]er [primary care physician] 911 called to transport to [emergency room] for evaluation & treatment.  Arbuckle Memorial Hospital ER report x-ray exam:  Left femoral neck fracture; and resident transferred to Ada Memorial Hospital.

CMS Ex. 7 at 99.

On January 10, 2020, a physician at the ER completed a History and Physical for R41.  CMS Ex. 7 at 103-06.  The physician stated that a registered nurse (RN) from Petitioner’s facility indicated that R41 “[c]omplained [of] left hip pain after a mechanic fall.”  CMS Ex. 7 at 103.  The physician’s assessment was that R41 had a closed fracture of her left hip with “Fall” being listed as an active problem.  CMS Ex. 7 at 106.  The physician decided to admit R41 to the hospital.  CMS Ex. 7 at 106.

On January 13, 2020, R41 had surgery related to the left hip fracture.  CMS Ex. 7 at 146.

A facility Incident Report dated January 15, 2020, stated that R41 was admitted to the hospital for left hip surgery and that, upon R41’s return, Petitioner would reassess R41’s needs and implement further interventions as deemed necessary.  CMS Ex. 7 at 97.

On January 17, 2020, the hospital discharged R41.  The discharge summary stated that the problems resolved at the hospital included:  “Closed fracture of left hip with routine healing” and “Left displaced femoral neck fracture.”  CMS Ex. 7 at 107.  The hospital treated R41 with “[o]pen treatment of [the] left midcervical femoral neck fracture, with prosthetic replacement.”  CMS Ex. 7 at 108, 110.  The discharge summary also warned that, because R41 was taking Eliquis 5mg twice daily for 30 days, Petitioner’s staff needed to “[b]e aware that this medication comes with an increased risk of bleeding.  If [R41] falls or hits her head take directly to an ER for evaluation.”  CMS Ex. 7 at 108.

R41 returned to Petitioner’s facility on January 17, 2020.  CMS Ex. 7 at 143.  Following return to the facility, R41 was considered terminally ill due to Alzheimer’s and started to receive hospice services.  CMS Ex. 7 at 24, 142.

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Petitioner added a new care plan entry for “Safety” with a “Problem Start Date” of January 17, 2020.  CMS Ex. 7 at 27.  The new entry specified that R41 had a “post op left hip fracture and is at risk for pain and immobility.”  CMS Ex. 7 at 27.  The long-term goal was to “Prevent immobility and decrease pain” within 90 days.  CMS Ex. 7 at 27.  The care plan approaches for this entry were to assist with activities of daily living (ADLs) as needed, give pain medications as ordered, maintain the adduction of the affected extremity, monitor for increased pain and discomfort, and observe for signs and symptoms of thrombophlebitis.  CMS Ex. 7 at 27-28.  The care plan did not provide new interventions to prevent falls.

Although Petitioner did not add interventions to help R41 to avoid falls, Petitioner’s staff again observed R41’s proclivity to walk unassisted.  On January 17, 2020, a progress note stated that R41 required one-on-one care because R41 was trying to get out of bed on her own.  CMS Ex. 7 at 142.  A January 18, 2020 progress note stated:  “Resident [41] sitting on side of bed.  Tried to talk to resident to have her lay back down but resident trying to get up ou[t] of bed.”  CMS Ex. 7 at 142.  A January 19, 2020 progress note stated:  “Resident trying to stand up from couch and wheelchair during beginning of shift.”  CMS Ex. 7 at 141.  Another January 19, 2020 progress note from later in the day stated:  “[R41] just now began trying to stand and walk, resident redirected to couch.”  CMS Ex. 7 at 141.  On January 20, 2020, a progress note stated that R41 made several attempts to ambulate without assistance.  CMS Ex. 7 at 141.  A January 22, 2020 progress note indicated that R41 attempted to come out of her room without wearing any clothes.  CMS Ex. 7 at 141.

On January 29, 2020, Petitioner’s staff conducted another MDS assessment.  CMS Ex. 7 at 8-19.  R41 had the following diagnoses:  hyponatremia; thyroid disorder; hip fracture; Alzheimer’s Disease; Non-Alzheimer’s Dementia; and Anxiety Disorder.  CMS Ex. 7 at 13-14.  The assessment again showed a 0 BIMS score, indicating severe cognitive impairment.  CMS Ex. 7 at 9.  The assessment for Functional Status changed dramatically from the previous MDS.  R41 needed extensive assistance with bed mobility, transfers between surfaces, and locomotion on and off R41’s unit, and R41 needed the assistance of one person for those tasks except for transfers between surfaces, which required two staff persons to assist.  CMS Ex. 7 at 11.  R41 did not walk during the assessment and now needed a wheelchair.  CMS Ex. 7 at 11-12.  The assessment indicated that R41 had recent falls and that a care plan for “Falls” was needed because R41 was “[a]t risk for falls/injury.”  CMS Ex. 7 at 15, 18.  The problem was described as follows:  “[R41] at risk for falls due to psychotropic medication, recent fall with hip fracture.  [R41] will stand, unable to balance self to safely walk independently, has recently begun using wheelchair for locomotion.  She is at risk for falls/injury.”  CMS Ex. 7 at 18.

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Despite this MDS assessment, on January 29, 2020, Petitioner renewed, unchanged, the care plan’s entry for “Falls” and left as the only approaches/interventions those identified originally on August 23, 2019, before R41 had fallen at the facility.  CMS Ex. 7 at 48-50.

On the same date that Petitioner renewed the care plan’s “Falls” entry with no new interventions, R41 fell again.  An Event Report stated that R41 fell in the facility common room.  The fall was witnessed but apparently not by facility staff.  The report stated that R41 had no pain and no apparent injury, and R41 was resting on a couch with no signs or symptoms of distress and that an X-ray of the left hip produced no acute findings.  CMS Ex. 7 at 111, 139.  The report also stated:  “Resident had hip pain prior to fall, unable to voice pain levels, resident shakes head right [t]o left, denying pain when asked if she []is hurt.”  CMS Ex. 7 at 112.  The report noted that R41 had been resting on a couch but was “[f]requently trying to stand up.  Resident fell during previous shift.”  CMS Ex. 7 at 114.

Although the January 17, 2020 discharge summary from the hospital warned Petitioner to send R41 to the ER if she fell during the next 30 days while she was receiving the medication Eliquis (CMS Ex. 7 at 108), there is no evidence in the record that Petitioner sent R41 to the hospital following the January 29 fall.  Petitioner did not add any new fall prevention interventions to the care plan following this fall.

On January 30, 2020, R41 fell again.  The fall was not witnessed and R41 was found on the floor of her room under her wheelchair.  CMS Ex. 7 at 139.  There is no evidence that Petitioner sent R41 to the ER.  Petitioner did not add any new fall prevention interventions to the care plan following this fall.

A January 31, 2020 Progress Note states that R41 is “[f]requently trying to stand up.”  CMS Ex. 7 at 139.

On February 1, 2020, R41 fell again.  Staff witnessed the fall in the hallway.  CMS Ex. 7 at 138.  There is no evidence that Petitioner sent R41 to the ER.  Petitioner did not add any fall prevention interventions to the care plan following this fall.

A February 2, 2020 Progress Note states that R41 “continues to attempt to get out [of] chair and bed with no assistance, resident unable to understand usage of call light for assistance.”  CMS Ex. 7 at 138.

On February 8, 2020, R41 fell again, for the sixth time in just over six weeks, in the hallway outside of her bedroom.  CMS Ex. 7 at 120, 124, 138.  The fall was not witnessed.  CMS Ex. 7 at 124.  R41 suffered bruising and laceration, and had “Severe Pain – Horrible, Intense.”  CMS Ex. 7 at 124.  The laceration was “[l]arge or deep . . . with jagged edges needing sutures” and there was “[u]ncontrolled bleeding with direct pressure applied.”  CMS Ex. 7 at 125.  An Event Report stated:

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Resident found laying on stomach in floor outside of her room in the hallway.  Assisted up and into wheelchair.  Laceration noted to left eyebrow with moderate bleeding from site.  Bruising starting to left cheek.  Pain voiced when left arm moved.  Care provided to laceration and bleeding controlled.  Resident grimacing and moaning d/t pain.  Dr. Frank and DON notified of fall.

CMS Ex. 7 at 125; see also CMS Ex. 7 at 120, 138.  The facility called EMS, which transported R41 to the ER.  CMS Ex. 7 at 120, 125, 138.  At the ER, an X-ray showed that R41 had a “nondisplaced fracture involving left proximal humeral surgical neck.”  CMS Ex. 7 at 133.  On February 8, 2020, Petitioner documented in an Event Report that R41 received a moderately deep skin tear that bleeds a small amount.  CMS Ex. 7 at 77.

R41 returned to the facility from the ER on February 9, 2020.  The ER applied Dermabond to R41’s left eyebrow and an immobilizer to R41’s left arm.  The ER also stated to Petitioner’s staff that R41 had a closed, non-displaced surgical neck fracture of the left humerus.  CMS Ex. 7 at 120, 125, 137.  R41 was to wear the immobilizer until her arm got better.  CMS Ex. 7 at 137.

A care plan entry for “Safety” with a “Problem Start Date” of February 10, 2020, specified that R41 had a “closed, non-displaced surgical neck fracture of the left humerus d/t fall.”  CMS Ex. 7 at 20.  The long-term goal was to “Prevent immobility and decrease pain” within 90 days.  CMS Ex. 7 at 20.  The care plan approaches for this entry were to assist with ADLs as needed, give pain medications as ordered, monitor for increased pain and discomfort, prevent pressure sores, and provide immobilizer care.  CMS Ex. 7 at 20-21.  The care plan did not provide new interventions to prevent falls.

A care plan entry for “Psychosocial Well-Being” with a “Problem Start Date” of February 10, 2020, specified that R41 had a “laceration to [the] left eyebrow.”  CMS Ex. 7 at 21.  The short-term goal was for the laceration to heal within 30 days.  CMS Ex. 7 at 21.  The care plan approaches for this entry were to observe for signs and symptoms of infection, follow the treatment ordered by the physician, use good antiseptic technique, and conduct a weekly skin assessment.  CMS Ex. 7 at 21.

On February 20, 2020, R41 died at Petitioner’s facility.  P. Ex. 4.

2. R28, a 96-year-old resident with cognitive deficits, entered the facility following a hospital stay for a clavicle fracture caused by a fall.  Based on an assessment of R28, Petitioner’s staff created a care plan entry that identified a risk for falls.  R28 fell four times within the first month at the facility, requiring R28 to go to the ER once.  Two weeks after the fourth fall, Petitioner’s staff conducted a new

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assessment, determined that R28 was at high risk for falls, and added a number of care plan interventions.  During the following month and a half, R28 fell twice from her wheelchair.

R28 was a 96-year-old woman who was admitted to Petitioner’s facility on November 15, 2019 for skilled nursing care to receive physical therapy (PT) and occupational therapy (OT).  See P. Ex. 6 at 22; CMS Ex. 8 at 21; P. Ex. 32 ¶ 68.  R28 had fallen at least two times within the six months before being admitted to the facility, with one of the falls occurring within a month of admission.  CMS Ex. 8 at 6.  Concerning the most recent fall before admission, R28 had been hospitalized for a clavicle fracture.  P. Ex. 6 at 21; CMS Ex. 8 at 21; P. Ex. 32 ¶ 68.

On November 18, 2019, R28 told facility staff that her vision was impaired due to macular degeneration.  Also on November 18, 2019, facility staff noted R28 had “weakness,” ambulated with a walker with assistance of one staff member and made transfers with the assistance of one staff member.  P. Ex. 6 at 21; CMS Ex. 8 at 21.

On November 19, 2019, R28 fell and sustained an injury that was not considered a “major injury.”  The fall was unwitnessed; however, staff found R28 outside, under a gazebo on the ground.  R28 stated that she hit the right side of her head, and staff did not note any other injuries at that time.  P. Ex. 6 at 20; CMS Ex. 8 at 6, 21.

On November 19, 2019, facility staff conducted an MDS assessment of R28.  CMS Ex. 8 at 1-10.  This assessment was made due to R28’s admission to the facility.  CMS Ex. 8 at 1.  R28’s BIMS score was 12.  CMS Ex. 8 at 2.  Facility staff assessed R28 as needing “limited assistance” and a “[o]ne person physical assist” for bed mobility, transfers between surfaces (e.g., bed, chair, wheelchair, standing position), walking in her room, walking in the corridor, and locomoting on and off R28’s unit.  CMS Ex. 8 at 3, 21.  Facility staff also indicated that R28 was “[n]ot steady, only able to stabilize with staff assistance” moving from a seated to standing position, walking, turning around, and transfers between bed and chair or wheelchair.  CMS Ex. 8 at 4.  R28 used a walker and a wheelchair.  CMS Ex. 8 at 4, 21.

The MDS assessment noted that R28’s PT had already started by the time of the assessment and R28 had received 90 minutes of therapy.  CMS Ex. 8 at 8.  Also, by the time of the MDS assessment, R28 had twice received restorative nursing care related to transferring.  CMS Ex. 8 at 9.  Finally, the MDS’s Care Area Assessment Summary noted that care planning issues included falls, cognitive loss, visual function, and psychotropic drug use.  CMS Ex. 8 at 10.

On November 20, 2019, the facility created a “Falls” entry in the resident’s care plan because:  “Risk for falls related to weakness, unsteady balance and gait.”  The long-term goal was to protect R28 from falls during the next 90 days.  However, there were no

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interventions listed in this care plan entry with a November 20, 2019 date.  CMS Ex. 8 at 19-20.

On November 23, 2019, R28 was caught smoking in her room; therefore, the facility took R28’s cigarettes so that she would have to ask staff for them when she wanted to smoke.  On November 23 and 24, 2019, progress notes stated that R28 “has been out to smoke a lot.”  P. Ex. 6 at 19; CMS Ex. 8 at 22.

On November 24, 2019, R28 had a fall in the hallway that was witnessed by a resident:  “ambulating w/ rolling walker, lost balance, fell to floor, resident did not hit head, no [signs or symptoms of] injury noted.”  P. Ex. 6 at 18; CMS Ex. 8 at 22.  Facility staff noted cigarette burn holes in R28’s robe and discussed smoking safety with R28.  P. Ex. 6 at 18; CMS Ex. 8 at 22.

On December 2, 2019, R28 was found lying on her back in the courtyard.  R28 complained of left shoulder pain and neck pain.  Staff called EMS, which transported R28 to a hospital.  The hospital determined that R28 did not have any new fractures, but hospital staff administered Norco (a pain medication) to R28.  R28 returned to the facility on the same day.  CMS Ex. 8 at 23.  Following R28’s return, facility staff “discussed safety issues [related to the] fall and supervised smoking . . . [R28] verbalized understanding.”  P. Ex. 6 at 15-16; CMS Ex. 8 at 23.

Progress notes on December 7, 2019, and December 11, 2019, indicated that R28 is “at times very confused.”  P. Ex. 6 at 13-14; CMS Ex. 8 at 24.

On December 12, 2019, facility staff found R28 sitting on the floor in her room in front of her wheelchair.  R28 stated that she slid off the wheelchair.  R28 did not complain of pain.  P. Ex. 6 at 13; CMS Ex. 8 at 24.

On December 14, 2019, R28 became a long-term care resident at the facility.  P. Ex. 6 at 12.

On December 27, 2019, R28’s physician ordered a hospice care evaluation and treatment for R28.  P. Ex. 6 at 11; CMS Ex. 8 at 25.

On January 1, 2020, facility staff conducted an MDS assessment for R28 due to a significant change in status.  CMS Ex. 8 at 11.  R28’s BIMS score dropped to 10, which is moderate cognitive impairment.  CMS Ex. 8 at 12; P. Ex. 32 ¶ 73.  The MDS assessment showed R28 now had an impairment in an upper extremity and only used a wheelchair, and not a walker, as a mobility device.  CMS Ex. 8 at 14.  The MDS assessment did not assess R28’s ability to walk but noted that R28 still needed supervision and a one-person physical assist for bed mobility and transferring between surfaces (e.g., from bed to chair or wheelchair).  CMS Ex. 8 at 13.  R28 also could only

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stabilize with staff assistance when transferring between surfaces, such as from bed to chair or wheelchair.  CMS Ex. 8 at 14.

The January 1, 2020 MDS assessment noted that R28 had three falls since the prior MDS assessment less than six weeks earlier.  CMS Ex. 8 at 16.  One of the falls resulted in no injury; however, two of the falls resulted in injuries that were not considered to be “major” injuries.  CMS Ex. 8 at 16.  The MDS assessment indicated that R28 received restorative nursing care for each of the preceding seven days related to transfers.  CMS Ex. 8 at 18.

Also on January 1, 2020, a facility RN observed R28 as part of a Fall Risk Assessment Tool.  The RN found there was a significant change in R28’s condition.  The RN’s assessment was that R28 had a total fall risk score of 16, which is a “High Fall Risk.”  CMS Ex. 8 at 27.  The fall risk assessment noted the following diagnoses for R28:  fracture of an unspecified part of the left clavicle; depressive episodes; Pseudobulbar affect; mood disorder due to known physiological condition; hypothyroidism; unspecified fall; sequela; personal history of other malignant neoplasm of large intestine; insomnia; lower back pain; and anorexia.  CMS Ex. 8 at 27.

On January 3, 2020, facility staff added the following interventions for the “Falls” care plan entry:  administer medications as ordered; assist with ambulation as needed; assist with transfers if needed; assure safety and take whatever measures are necessary to ensure safety; bed in low position if needed; encourage resident to request assistance; keep call light within reach, promote the proper use of the hand rolls and grips in the bathroom; requires assistance to go outside and smoke due to history of falling in courtyard.  CMS Ex. 8 at 19-20.

Progress notes for early January 2020 indicate that R28 was persistently but sporadically verbally aggressive and unkind, and once hit another resident.  P. Ex. 6 at 7-11.

On January 26, 2020, a progress note records another fall:  “Resident found sitting on the floor in her room between bed and wheelchair in her room.  Resident denies injury and denies hitting her head.  States that she ‘did not fall out of the bed’ but couldn’t explain how she ended up sitting on the floor by her bed.  Resident extremely rude to staff.  Will continue with fall monitoring.”  P. Ex. 6 at 4; CMS Ex. 8 at 25.

On February 8, 2020, R28 bit another resident during an altercation.  P. Ex. 6 at 3.

On February 14, 2020, a progress note recorded another fall for R28:  “Resident found sitting on the floor in front of her [wheelchair], [R28] states she was getting out of bed trying to get in her [wheelchair], [R28] states she did not hit her head, resident assessed @ this time & assisted back in her [wheelchair], no apparent injuries noted.”  P. Ex. 6 at 2; CMS Ex. 8 at 26.  R28 did not complain of pain following the fall.  P. Ex. 6 at 1-2.

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3. R34, a 62-year-old resident who had one leg amputated below the knee and toes removed from the foot on the other leg, was only able to ambulate using a wheelchair.  Petitioner’s staff originally assessed R34 in April 2019 as needing two staff members to assist her in transferring back and forth between her bed and wheelchair.  After R34 fell in June 2019, when attempting that transfer alone, Petitioner’s staff added “Falls” to R34’s care plan in July 2019, but did not provide any specific interventions.  However, in August 2019, a physician ordered a slide board for R34 to use when transferring.  Petitioner did not provide the slide board to R34.  In a subsequent assessment in October 2019, Petitioner’s staff determined that R34 only needed supervision and set up for her to transfer between her bed and wheelchair.  In December 2019, R34 fell while independently transferring between her bed and the wheelchair.  A nurse practitioner ordered a trapeze bar to be installed over R34’s bed as an assistive device.  Probably before the trapeze bar could be installed, in January 2020, R34 fell again while independently transferring between her bed and the wheelchair.  Petitioner added interventions to the resident’s care plan for falls.  However, R34 fell again while trying to independently transfer from her bed to the wheelchair.

R34, a woman in her early 60’s during the relevant period in this case, was admitted to Petitioner’s facility from an acute care hospital on April 4, 2019.  CMS Ex. 9 at 2, 4.  R34’s active diagnoses included:  absence of left leg below the knee; absence of right foot toes; morbid obesity; chronic obstructive pulmonary disease (COPD); deep venous thrombosis; diabetes; arthritis; and asthma.  CMS Ex. 9 at 10-11, 59.

On April 17, 2019, facility staff conducted an MDS assessment of R34.  CMS Ex. 9 at 1-11.  R34’s BIMS score was 14.  CMS Ex. 9 at 6.  R34’s lower extremity on one side of her body was impaired and R34 used a wheelchair.  CMS Ex. 9 at 9.  R34’s functional status included:  no assistance needed for bed mobility; extensive assistance by two persons for transfers between surfaces (e.g., bed, chair, wheelchair, standing position); and supervision and set up assistance needed for locomotion on and off R34’s unit in the facility.  CMS Ex. 9 at 8.

On June 22, 2019, staff responded to a call light and found R34 sitting on the floor.  R34 stated that she “went to the floor when transferring herself.  Stated she has pain in . . . right knee, no swelling noted, stated she did not hit her head only her bottom.”  CMS Ex. 9 at 90.  On July 18, 2019, the facility added an entry to R34’s care plan for “Falls”; however, the care plan does not show any interventions to be implemented at that time.  CMS Ex. 9 at 90.  One of Petitioner’s witnesses testified that this care plan entry “included typical fall interventions.”  P. Ex. 32 ¶ 59.

On August 5, 2019, R34’s physician ordered the use of a slide board for R34’s transfers.   CMS Ex. 9 at 50.  A slide board is used to assist a resident transferring between a bed and

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wheelchair.  Tr. 40.

On October 17, 2019, facility staff conducted an MDS assessment of R34.  CMS Ex. 9 at 12-20.  Although the MDS assessment indicated that it is a quarterly assessment, the MDS also indicated that R34 had reentered the facility from an acute care hospital on October 14, 2019.  CMS Ex. 9 at 12, 14.  R34’s BIMS score was 13.  CMS Ex. 8 at 16.  R34’s lower extremity on one side of her body was impaired and R34 used a wheelchair.  CMS Ex. 9 at 19.  R34’s functional status included:  “limited assistance” and a “[o]ne person physical assist” for bed mobility; and supervision and set up assistance for transfers between surfaces (e.g., bed, chair, wheelchair, standing position) and for locomoting on and off R34’s unit.  CMS Ex. 9 at 18-19.  R34 was “[n]ot steady, only able to stabilize with staff assistance” moving from a seated to standing position.  CMS Ex. 9 at 19.  The assessment also indicated that R34 had a fall sometime in the last two to six months before reentry at the facility, likely the June 22, 2019 fall.  CMS Ex. 9 at 20.

On December 21, 2019, R34 fell trying to get into her wheelchair from her bed.  CMS Ex. 9 at 22; see also Tr. 37.  R34 was found on the floor beside her bed.  CMS Ex. 9 at 26.  R34 told staff that she forgot to lock the wheels of the wheelchair before the transfer. CMS Ex. 9 at 26; P. Ex. 5 at 12.  R34’s leg was scraped, with a pain level of three on a scale of zero to ten.  CMS Ex. 9 at 22, 26; P. Ex. 5 at 12.  Staff encouraged R34 “to please put [call] light on and let us help her into the chair.  [J]ust smiled and stated she can get up on her own.”  CMS Ex. 9 at 25-26; P. Ex. 5 at 12.  Staff were to monitor R34 for 72 hours for bruising or other injuries related to the fall.  CMS Ex. 9 at 25.

On December 30, 2019, a nurse practitioner ordered a trapeze bar to assist R34 in transfers.  CMS Ex. 9 at 50; P. Ex. 5 at 9.  The trapeze bar would allow R34 to use her upper body strength to independently move from the bed to her wheelchair.  Tr. 62.

On January 1, 2020, R34 fell in her room and was found on the floor between her bed and her wheelchair.  R34 said she slid from the bed while transferring from her wheelchair to the bed.  R34 had an abrasion to her left scapula and a soft tissue injury to the right scapula.  R34 rated her pain as a three.  Staff encouraged R34 to call for assistance to transfer.  CMS Ex. 9 at 21, 27, 34, 58; P. Ex. 5 at 8; see also Tr. 37-38.

On January 14, 2020, facility staff added interventions to the care plan’s entry for “Falls,”  including:  assessing and treating for postural/orthostatic hypotension; encouraging the use of call light for assistance with transfers; increasing staff supervision with intensity based on resident need; directing pharmacist to conduct a comprehensive medication review to assess polypharmacy and medications that increase fall risk; and providing individualized interventions based on needs/patterns.  CMS Ex. 9 at 90.  The care plan listed the risk of falls was due to the loss of R34’s left leg, the use of a wheelchair, and the use of a slide board for transfers into the wheelchair.  CMS Ex. 9 at 90.

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Also, on January 14, 2020, facility staff added an entry in R34’s care plan for “Visual Function” because R34 was “[a]t risk for injury d/t impaired vision.”  CMS Ex. 9 at 65.  The care plan interventions included encouraging independence with ADLs, ensuring adequate lighting, and keeping the environment free of clutter.  CMS Ex. 9 at 65.

On January 22, 2020, R34 fell in her room while trying to transfer from the bed to the wheelchair by herself.  R34 told staff that her left hip had been hurting her prior to the fall and rated her pain as a four, which is “Moderate Pain – Distressing, Miserable.”  CMS Ex. 9 at 42, 58; P. Ex. 5 at 1; see also Tr. 37-38.  Staff were to monitor R34 for 72 hours for bruising or other injuries related to the fall.  CMS Ex. 9 at 45.

4. Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(2) because it did not take all reasonable steps to provide the supervision and assistance devices necessary to prevent foreseeable accidents by three residents.

The Social Security Act requires SNFs to “care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident” and “provide services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, in accordance with a written plan of care which describes the medical, nursing, and psychosocial needs of the resident and how such needs will be met.”  42 U.S.C. § 1395i-3(b)(1)(A), (2).

In furtherance of these statutory requirements, the Secretary promulgated the “quality of care” requirements at 42 C.F.R. § 483.25.  One requirement imposes specific obligations on a facility related to resident supervision and accident prevention as follows:5

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.

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42 C.F.R. § 483.25(d).  Section 483.25(d)(1) requires a facility to 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 at 10 (2005).  Section 483.25(d) “come[s] into play when there are conditions in a facility that pose a known or foreseeable risk of accidental harm.”  Meridian Nursing Ctr., DAB No. 2265 at 9 (2009), aff’d sub nom., Fal‑Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010).  Section 483.25(d)(2) requires facilities to 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 have “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).  Therefore, “[t]he standard of care imposed by these ‘as is possible’ and ‘adequate supervision’ regulations has been consistently interpreted by the [Department of Health and Human Services] and federal courts as a ‘reasonableness’ standard.”  Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010).

In the present case, CMS argues that the specific facts concerning R28, R34, and R41 show that Petitioner failed to properly determine the cause for their falls and, as a result, multiple falls ensued for each resident.  CMS Br. at 20-21.  CMS cited to DON Smith’s testimony to show that Petitioner’s staff did not think it was necessary to document the details of their discussions or interventions in resident care plans because it was not practical to do so after each fall.  CMS Br. at 21-22 (citing Tr. 31-32, 74, 77-78, 81).

Petitioner responds to CMS by pointing to DON Smith’s testimony concerning meetings held “each weekday morning to review all resident issues” as sufficient to meet Petitioner’s obligation to consider the reason for resident falls.  P. Br. at 10, 12.  Petitioner argues that it is only required to consider the falls and whether any changes are needed but that it is not required to document those deliberations.  P. Br. at 11-12.

In this case, I am to determine, in relation to R28, R34, and R41, whether Petitioner “ensured” that “[e]ach resident receive[d] adequate supervision and assistance devices to prevent accidents.”  42 C.F.R. § 483.25(d)(2).  When conducting this analysis, I need to determine whether any accidents, in this case falls, were foreseeable.  As stated earlier in this decision, if CMS makes a prima facie showing of a deficiency, Petitioner has the burden of proving substantial compliance.  There is no dispute that Petitioner identified a fall risk for each of the residents and that those residents proceeded to have multiple falls

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after the risk had been identified.  Indeed, each of these residents had a history of falls.  Therefore, I must consider whether the record shows Petitioner provided “adequate supervision and assistive devices.”
As part of my analysis, I must consider whether the care plan interventions provided for each of the residents were adequate and implemented.  When considering an alleged deficiency under section 483.25(d), it is appropriate to look at relevant care plan interventions because section 483.25 “effectively incorporates” the regulatory requirements for assessments and individualized care plans in its introductory language, which requires that a facility provide each resident “the necessary care or services to attain or maintain the highest practical physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.”  Buena Vista Care Ctr., DAB No. 2498 at 16 (2013) (internal citations and emphasis omitted).  Further, the measures required in a care plan “are evidence of the facility’s evaluation of what must be done to attain or maintain a resident’s ‘highest practicable physical, mental, and psychosocial well-being’ as required by the overarching introductory language to section 483.25.”  Blossom South Nursing and Rehabilitation Ctr., DAB No. 2578 at 13 (2014).

I now consider whether Petitioner was in substantial compliance with 42 C.F.R. § 483.25(d) based on the circumstances involving R41, R28, and R34.

The record shows that R41’s falls were foreseeable.  Petitioner identified and care planned for the risk of falls as early as August 2019.  CMS Ex. 7 at 48-50; P. Ex. 32 ¶¶ 17, 20.  DON Smith also testified that R41 immediately had a care plan put into place for fall prevention because of her assessed risks of falling due to dementia and R41’s “insistence on ambulating without assistance in both a wheelchair and sometimes walking.”  P. Ex. 32 ¶ 21.  Further, R41 had a fall on December 27, 2019, which resulted in lacerations to her face and a trip to the ER.  CMS Ex. 7 at 68, 150.

R41’s December 27, 2019 fall should have resulted in facility staff increasing supervision of R41 and/or assistance to avoid future falls.  Even without adding new interventions, the care plan in place on December 27, 2019, required the following:  “Increased staff supervision with intensity based on resident need.”  CMS Ex. 7 at 49.  After all, the goal of the care plan was that “Resident will be free of falls.”  CMS Ex. 7 at 49.

There is no evidence that, following the December 27, 2019 fall, Petitioner evaluated whether R41’s needs required increased supervision to ensure the care plan goal of having no falls could be achieved.  To the contrary, on December 30 and 31, 2019, Petitioner’s staff simply noted that R41 was ambulating in the hallway and common areas of the facility with no indication of supervision.  CMS Ex. 7 at 148-49.  A lack of supervision is clear from a January 2, 2020, notation that R41 was going into the rooms of other residents and taking things.  CMS Ex. 7 at 148.  Had R41 been more closely supervised, she would not have been allowed to do this.  Nor, as noted on January 8, 2020, would R41 have been allowed to follow staff into the rooms of other residents or to

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push other residents around in their wheelchairs, had she been more closely supervised.  CMS Ex. 7 at 147.

Without increased supervision, on January 10, 2020, R41 fell resulting in a hip fracture that required a hospital stay and surgical repair.  CMS Ex. 7 at 89-92, 99, 103-08, 146.

The facility Incident Report from January 15, 2020, stated that upon R41’s return to the facility, Petitioner would reassess R41’s needs and implement further interventions as deemed necessary.  CMS Ex. 7 at 97.  Although R41’s return to the facility on January 17, 2020 resulted in her receiving hospice care and a new care plan entry for “Safety,” Petitioner did not add any interventions to the care plan for fall prevention.  CMS Ex. 7 at 20-21, 27-28, 48-50, 142.  There is also no evidence that Petitioner implemented the existing care plan intervention for increasing supervision based on R41’s needs.

While there was no additional supervision, staff continued to observe R41 walking unassisted.  A January 17, 2020 progress note stated that R41 required one-on-one care because R41 was trying to get out of bed on her own.  CMS Ex. 7 at 142.  Despite this, there is no evidence that one-to-one care was provided or, if it were provided, that it lasted more than a brief time.  Still, there may have been some additional supervision in practice because staff intervened multiple times between January 18 and January 22, to redirect R41 from walking unassisted.  CMS Ex. 7 at 141-42.

It was not until January 29, 2020, that Petitioner’s staff conducted another MDS assessment, which found significant changes to R41’s functional status.  CMS Ex. 7 at 8-19.  R41 still had a BIMS score of zero; however, R41 now needed extensive assistance with bed mobility, transfers between surfaces, and locomotion on and off R41’s unit, and R41 needed the assistance of one person for those tasks except for transfers between surfaces, which required two staff persons to assist.  CMS Ex. 7 at 9, 11.  The assessment indicated that R41 had recent falls and that a care plan for “Falls” was needed because R41 was “[a]t risk for falls/injury.”  CMS Ex. 7 at 15, 18.  The problem was described as follows:  “[R41] at risk for falls due to psychotropic medication, recent fall with hip fracture.  [R41] will stand, unable to balance self to safely walk independently, has recently begun using wheelchair for locomotion.  She is at risk for falls/injury.”  CMS Ex. 7 at 18.  Despite this MDS assessment, on January 29, 2020, Petitioner renewed, unchanged, the care plan’s entry for “Falls.”  CMS Ex. 7 at 48-50.

Even without new interventions, the care plan for “Falls” still had the goal of R41 remaining free from falls and required increased staff supervision with intensity based on resident need.  Unsurprisingly, on the same day that the MDS assessment warned of R41’s inability to safely walk on her own, R41 fell in a common room at the facility.  While the Event Report indicates that fall was witnessed, the “[f]all [was] not witnessed by staff.”  CMS Ex. 7 at 111.  Therefore, R41 was not supervised during the fall.

The next day, January 30, 2020, R41 fell again.  The fall was not witnessed, showing that R41 was not supervised, despite the fact that it was now obvious that the “intensity” of R41’s needs required more supervision under the care plan.  CMS Ex. 7 at 139.
The following day, January 31, 2020, staff noted that R41 is “[f]requently trying to stand up.”  CMS Ex. 7 at 139.  Unsurprisingly, on February 1, 2020, R41 fell again.  This time, facility staff witnessed the fall in the hallway but were too far away to stop the fall.  CMS Ex. 7 at 138; P. Ex. 34 at 1.  Therefore, supervision for R41 was again lacking.

On February 2, 2020, staff noted that R41 “continues to attempt to get up out [of] chair and bed with no assistance, resident unable to understand usage of call light for assistance.”  CMS Ex. 7 at 138.  Despite this awareness of R41’s efforts to keep standing and walking unassisted, there is no evidence that Petitioner took any action to increase supervision, as required by the care plan.  Then, on February 8, 2020, R41 fell again, for the sixth time, in the hallway outside of her bedroom.  CMS Ex. 7 at 120, 124, 138.  Facility staff were not supervising R41 because the fall was not witnessed.  CMS Ex. 7 at 124-25.  R41 suffered bruising, a laceration, uncontrolled bleeding, and fracture in her left arm.  CMS Ex. 7 at 120, 124-25, 133, 138.  Within two weeks, R41 died.  P. Ex. 4.

The lack of documentary evidence showing that Petitioner complied with the care plan and increase supervision of R41 to prevent falls is not helped much by the testimony of Petitioner’s witnesses.  Petitioner’s witnesses agree that from December 2019, R41’s health deteriorated rapidly.  DON Smith stated that the nursing notes for R41 showed that “she was very rapidly declining, to the point that her falls were unavoidable.”  P. Ex. 32 ¶ 16.  DON Smith also testified that R41 refused nutrition, medications, and assistance, and opined that the falls occurred due to R41’s declining strength.  P. Ex. 32 ¶¶ 23-25, 27-31, 50-52.  Derra Eppler, R.N., the Vice President for Clinical Services at Elmbrook Management Company, agreed with DON Smith and testified that she also believed R41’s falls were unavoidable based on R41’s declining health situation.  P. Ex. 33 at 3.  Robyn Gilbreath, LPN, testified that R41’s “decline was so rapid, and she was actually in pretty good physical condition (as compared to her mental status) her falls were very difficult to predict or prevent.”   P. Ex. 38 at 2.  But LPN Gilbreath also confirmed R41 “constantly wanted to be walking around the facility.”  P. Ex. 38 at 1.  All of this testimony simply makes it clear that the care plan provision that required more supervision of R41 based on the “intensity” of R41’s needs was not followed by Petitioner’s staff.  After all, the care plan’s goal was for R41 to be free of falls.

Petitioner’s witnesses, however, take the position that Petitioner provided adequate supervision and interventions for R41.  DON Smith testified that Petitioner’s staff provided “multiple interventions to try to keep her from getting out of bed and preventing the resident from attempting to ambulate unaccompanied.”  P. Ex. 32 ¶ 35.  DON Smith indicated that R41’s care plan showed that extensive assistance was to be provided to R41 with a number of activities of daily living.  P. Ex. 32 ¶ 36.  LPN Gilbreath testified that R41 was assisted with showering, dressing, and toileting.  P. Ex. 38 at 2.  DON

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Smith also alleged that “[m]any of these interventions increased the provision of one on  one care during key activities where there is a higher risk of falls.”  P. Ex. 32 ¶ 38.  DON Smith testified that the care plan included an exercise program to target strength, gait, and balance, and additional staff supervision, and LPN Gilbreath generally testified R41 did exercise programs and therapies for strength, gait, and balance.  P. Ex. 32 ¶ 41; P. Ex. 38 at 2.  DON Smith further testified that the care plan indicated staff needed to monitor R41’s whereabouts, and nursing notes indicated there was 72-hour monitoring for R41 following her falls, staff assisted R41 back to her room on multiple occasions, staff placed a call light in reach of R41, staff placed a fall mat next to R41’s bed, and R41 used a wheelchair.  P. Ex. 32 ¶¶ 43-47.  LPN Gilbreath testified that, during those 72-hour monitoring periods, R41 was “monitored extra closely,” which included assisting her  “back to her room and her bed,” and making sure the call light was “always in reach.”  P. Ex. 38 at 2.  LPN Gilbreath testified that R41’s falls were “very difficult to predict or prevent.  She really did not want to be kept in her room and would insist on walking without assistance despite staff closely watching her and offering to assist.”  P. Ex. 38 at 2.  LPN Gilbreath stated that staff made sure R41 was in common rooms and visible to staff; however, LPN Gilbreath also admitted that at least one fall was witnessed by staff who could not prevent the falls.  P. Ex. 38 at 2-3.  Tijuana Hooks, CMA/CNA, testified that she witnessed the fall but could not prevent it.  P. Ex. 34 at 1.  LPN Gilbreath said she would remind R41 to use the call light and not to walk unassisted.  P. Ex. 38 at 3.

Some of this testimony is corroborated by the documentary record, but much of it is not.  DON Smith admitted that one-to-one supervision is not documented, and there are no records indicating that R41 was placed on one-to-one coverage.  Tr. 50-51.  Further, increasing supervision for only the 72-hour periods following each fall is insufficient to comply with the care plan requirement that supervision in general must be based on the intensity of the need for the supervision.  As the witnesses testified, R41’s need for supervision was continually increasing as R41 experienced significant cognitive decline.

In addition, witness testimony that R41 would be reminded to use a call light and not to walk unassisted was not an effective intervention.  As stated above, R41 had a BIMS score of zero and staff documented that R41 could not understand the cues to use the call light.  CMS Ex. 7 at 9, 138.  Therefore, verbal warnings and cues do not substitute for providing the supervision required by the care plan.  See Fal‑Meridian, 604 F.3d at 451.

In addition to failing to comply with the care plan for R41 concerning “Falls,” Petitioner also failed to add interventions to that care plan as R41’s situation continued to decline.  Although there is little documentary evidence that new interventions were considered or implemented, DON Smith testified that the facility would add new interventions or care plan updates after a resident has a fall, and after each subsequent fall.  Tr. 31-32.  She admitted that it would be a good practice to reassess interventions if the current ones were not working.  Tr. 32.  However, DON Smith later stated that she did not agree that a care plan needs to be changed after each fall.  Tr. 51-52.

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DON Smith also testified that, following a fall, staff would check whether anything needed to be changed, such as removing room clutter or changing resident footwear, but such actions would not be documented.  Tr. 54.  DON Smith testified that the facility interdisciplinary team would review the care plan after each fall and that one should infer that the interdisciplinary team did not believe that new interventions were needed if none were added to the care plan.  However, DON Smith admitted that decisions as to whether additional interventions in a care plan should or should not be made should be documented.  Tr. 78.  She also agreed that interventions related to a resident’s fall should be documented in the resident’s clinical records.  Tr. 79.  DON Smith also admitted that the interdisciplinary team’s review of interventions that nurses may implement after an incident, like a fall, would not be documented in the resident’s medical record.  Tr. 81.  DON Smith testified that staff would know that no additional interventions were added following an incident because the care plan would not change; however, the consideration to add interventions would not be written down.  Tr. 85-86.

In the record, there are no documents showing that Petitioner added interventions to R41’s care plan concerning “Falls” during the time period when R41 had six falls.  I do not find DON Smith’s testimony credible that an interdisciplinary team actively, yet silently, considered additional interventions after R41’s falls and determined there were none to be made.  Even if this were true, as I concluded above, Petitioner failed to implement the care plan for “Falls” by neglecting to increase supervision of R41 based on her mental decline and increasingly dangerous (for her) behaviors.

LPN Gilbreath testified that the facility implemented the “usual fall preventions as her care plan stated,” which “included trying to calm and orient [R41], revising her medications, multiple interventions to try to keep her from getting out of bed and preventing [her] from attempting to ambulate unaccompanied.  She was assisted with showering, dressing, and toileting.  After falls, she was monitored extra closely for 72 hours.”  P. Ex. 38 at 2.  While LPN Gilbreath’s testimony may broadly be true, R41 fell too many times while unsupervised to credit Petitioner with fully complying with the care plan intervention that required more supervision based on the intensity of the need.

DON Smith testified that Petitioner could not restrain R41 or confine her to bed, but that “[y]ou just keep her as safe as you can.”  Tr. 56.  DON Smith did not think there was a practical way to stop R41’s falls and that nothing else could be done short of restraining her.  Tr. 57-58.  LPN Gilbreath appears to agree.  P. Ex. 38 at 3.  However, Petitioner could have simply followed the care plan and increased supervision as R41’s health declined.  The progress notes mention that one-to-one supervision would help.  CMS Ex. 7 at 142.  But even conducting 15-minute checks may have helped significantly.  Using staff to supervise cognitively impaired residents to avoid accidents is not a prohibitively expensive intervention.  Fal‑Meridian, 604 F.3d at 450.  In the present case, R41 was on hospice care and providing increased supervision was likely to be of limited duration.

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Given the number of falls, the injuries sustained, Petitioner’s failure to implement the care plan intervention to increase supervision, and a failure to consider and implement additional interventions, I conclude that Petitioner failed to provide adequate supervision of R41 to prevent accidental falls, which had a risk of more than minimal harm.

I draw a similar conclusion for R28.

CMS asserts that R28 fell five times within three months and Petitioner did not analyze the cause of the falls or add interventions to prevent the falls.  CMS Br. at 21.  Petitioner disagrees and asserts that it conducted all appropriate risk assessments, implemented standard fall precautions, and added new interventions as R28 began to fall.  P. Br. at 20.  Petitioner argues that it successfully monitored R28 and properly medicated R28 to manage R28’s underlying behavior to stop her falls.  P. Br. at 20-21.

In November 2019, R28 was new to the facility but was quite elderly at age 96 and came with a history of falls.  See P. Ex. 6 at 22; CMS Ex. 8 at 6, 27; P. Ex. 32 ¶ 68.  In fact, R28 had just been hospitalized for a clavicle fracture due to a fall.  P. Ex. 6 at 21; CMS Ex. 8 at 21; P. Ex. 32 ¶ 68.  Based on R28’s fall and fracture, which led to her hospital stay and admission to Petitioner’s facility, I conclude that further falls were reasonably foreseeable unless appropriate interventions were implemented.

Despite R28 being an obvious fall risk, Petitioner did not expedite the MDS assessment for R28.  Before conducting an assessment and entering care plan interventions, R28 was permitted to independently walk around the facility and outside the facility to smoke.  R28 fell on November 19, 2019, while walking alone outside the facility.  P. Ex. 6 at 20; CMS Ex. 8 at 6, 21.  Although facility staff conducted the MDS assessment the same day as the fall, and created a care plan entry for “Falls,” the facility did not state interventions to achieve the stated care plan goal that R28 “[w]ill be protected from falls for the next 90 days.”  CMS Ex. 8 at 19-20.  This failure to add care plan interventions made it nearly meaningless, other than to alert staff that R34 was at risk for falls.

DON Smith characterized R28’s care plan made on admission as having “common interventions” as well as PT and OT.  P. Ex. 32 ¶ 74.  I cannot credit this testimony because the care plan document does not show any interventions (CMS Ex. 8 at 19-20) entered on November 20, 2019, and DON Smith’s testimony is too vague as to specific interventions implemented.  DON Smith may be referring to basic interventions started  by staff before the MDS assessment.  If so, these were not entered into the care plan and did not generally require supervision for R28 while she was walking with her walker.

This situation is troubling because R28’s first fall at the facility, on November 19, 2019, occurred while R28 was allowed to go and smoke outside alone.  LPN Gilbreath testified that she found R28 on the ground and that R28 had been smoking.  P. Ex. 38 at 4.

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Only five days later, on November 24, 2019, R28 lost her balance while using a walker and fell.  P. Ex. 6 at 18; CMS Ex. 8 at 22.  This fall did not result in an evaluation for care plan interventions and R28 was allowed to walk unsupervised in and outside the facility.  Therefore, it was not surprising that, on December 2, 2019, R28 was found lying on her back in the courtyard after a fall.  P. Ex. 6 at 16; CMS Ex. 8 at 23.  Although LPN Gilbreath stated that R28 had not fallen again outside after the first outdoor fall (P. Ex. 38 at 4), DON Smith acknowledged that R28 fell twice outside before the facility supervised R28 when she went outside to smoke.  P. Ex. 32 ¶ 76.

DON Smith acknowledged that R28 hit her head during the first fall.  Tr. 32-33.  Further, DON Smith acknowledged that R28’s second fall outside on December 2, 2019 (but third fall overall since entering the facility) was a serious fall because EMS transported R28 to the hospital.  Tr. 33.  Therefore, it took a second fall outside before Petitioner required supervision for R28 when she went outside to smoke.

Supervision while going outside was not added to the care plan.  Nor was supervision required by the care plan while R28 was in the facility.  It is not surprising that, on December 12, 2019, R28 was found inside the facility on the floor in front of her wheelchair.  P. Ex. 6 at 13; CMS Ex. 8 at 24.  Because R28 had already fallen inside the facility, supervising her only while outside was insufficient to protect R28 from falls.

DON Smith testified that R28’s January 1, 2020 assessment showed that R28 was a high fall risk.  Tr. 34; CMS Ex. 8 at 27.  DON Smith testified that additional interventions were added to R28’s care plan on January 3, 2020, which included “staff assistance with ambulation and transfers if needed, approaches for the staff to assure safety and take whatever measures necessary to ensure safety, for the resident’s bed to be in low position at all times, to encourage [R28] to ask for assistance, to keep the call light within reach, to promote proper use of hand rolls, and hand grips in the bathroom.”  P. Ex. 32 ¶ 81.  However, all of this only occurred after R28 had already fallen four times at the facility.

LPN Gilbreath testified that staff implemented the care plan interventions and “she was regularly watched for assistance with ambulation and transfers.  She was assisted when smoking or going outside.  She was assisted with bathing and dressing.”  P. Ex. 38 at 5.  DON Smith testified that R28 “was monitored closely” due to her aggressive behavior and smoking.  P. Ex. 32 ¶ 78.  DON Smith testified that R28 was a challenging resident, listing her aggressive behaviors and dangerous smoking habits.  P. Ex. 32 ¶¶ 70-71.  LPN Gilbreath testified that R28’s aggressive behavior made it more challenging to care for her.  P. Ex. 38 at 5.  Despite these interventions, R28 fell two more times, on January 26, 2020, and February 14, 2020.  P. Ex. 6 at 2, 4; CMS Ex. 8 at 25, 26.

DON Smith admitted that there were no additional updated care plan interventions after the two additional falls occurred following the care plan updates on January 3, 2020.  Tr.

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36.  Despite this, DON Smith testified that an interdisciplinary team evaluated each fall that R28 had and that one could infer that no additional interventions meant that the team believed the facility was doing all it could do.  Tr. 60.  DON Smith testified that there would not be documentation of the interdisciplinary team’s evaluations unless an in service was done, and that it would be impractical to document all of the assessments and interventions in the care plan each time they were considered or made.  Tr. 72-74.

There is no doubt that the record shows that R28 was a challenging resident.  She appears to have been verbally and, sometimes, physically aggressive.  However, as DON Smith confirmed, R28 fell a total of six times at the facility.  P. Ex. 32 ¶¶ 67, 76-77; see also Tr. 32-33, 35.  Petitioner was extremely slow to create and implement interventions for R28 and there is no evidence that Petitioner provided supervision to R28 while ambulating, except when R28 went outside to smoke, and then only after two falls outside had already occurred.  R28 also fell twice within the facility before any meaningful interventions were added to the care plan.  Even then, after two more falls occurred, Petitioner did not seek to modify the interventions or provide more supervision.  Further, R28 was injured or was subjected to the risk of more than minimal harm based on these falls.

Unlike R41 and R28, R34 was significantly younger and had intact cognition.  R34’s main risk for falls was the loss of a leg and her obesity, which made unassisted transfers to and from her bed to her wheelchair risky.  This risk was first made clear to Petitioner’s staff in June 2019 when R34 was found in her room on the floor between the bed and her wheelchair.  CMS Ex. 9 at 90 (evaluation notes for a June 22, 2019 fall entered into care plan).  This fall was not surprising because an MDS assessment two months earlier indicated that R34 needed extensive assistance from two (or more) persons for transfers between surfaces (e.g., bed, chair, wheelchair, standing position).  CMS Ex. 9 at 8.  The June 2019 fall now alerted staff that R34 would self-transfer.  LPN Gilbreath testified that R34 “is morbidly obese and will try to transfer herself from the bed to the chair using her weight.  I think that’s likely how her falls happened-she would not wait any amount of time for staff to help her transfer (when she chose to use the call light).  We constantly reminded her to do that, and she can understand direction and voices her understanding, but then sometimes would choose to self-transfer anyway.”  P. Ex. 38 at 3.

After the June fall, in July 2019, Petitioner rightly added an entry to R34’s care plan for “Falls”; however, it wrongly did not include specific interventions.  CMS Ex. 9 at 90.  The first potential intervention came in August when R34’s physician ordered an assistive device for R34, a slide board for transfers.  CMS Ex. 9 at 50.

At this point, the record becomes unclear whether Petitioner ever provided R34 with the assistive device (slide board) ordered by the physician.  LPN Gilbreath testified that R34 has a slide board that helped her to get from the bed to her wheelchair; however, R34 did not use it in December 2019 when she started to fall.  P. Ex. 38 at 3.  Nurse Eppler’s testimony supports LPN Gilbreath’s testimony, stating:  “Each of her falls occurred when

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she was transferring herself from her wheelchair to her bed without using a slide board, which her physician had recommended.”  P. Ex. 33 at 6.  Although DON Smith’s testimony generally comported with these other witnesses when she stated that R34’s falls involved transferring herself to or from her wheelchair without assistance and without using a slide board (P. Ex. 32 ¶ 58), DON Smith also testified that Petitioner never provided R34 with the slide board.  See Tr. 42, 44.

DON Smith testified that, before a slide board could be provided, PT or OT would need to evaluate whether a slide board was safe for R34 to use.  Tr. 42-43, 61.  DON Smith believed that R34 was evaluated for slide board use, but the slide board was rejected in favor of a trapeze bar.  Tr. 61-62.  However, the record does not contain an evaluation or conclusion by PT or OT, and, as DON Smith stated, the order for a slide board should have been deleted from R34’s records if R34 could not use it.  Tr. 62.  DON Smith explained potential reasons why a slide board may be unsafe for R34 to use (Tr. 62-64); however, that does not prove that PT or OT found that the slide board was unsafe for R34 to use.  Further, DON Smith’s testimony that the slide board was rejected in favor of the trapeze bar is problematic because each of those devices was ordered months apart, which may mean that PT or OT did not evaluate the use of both of those assistive devices until December 2019, when the trapeze bar was ordered.  See CMS Ex. 9 at 50.

Further creating questions is R34’s care plan entry for “Falls,” which indicates that a reason R34 was at risk for falls was that she “uses slide board for transfers into w/c.”  CMS Ex. 9 at 90.  Does this mean that R34 had a slide board and used it, causing a fall risk?  Or, does this mean, consistent with the testimony of LPN Gilbreath and Nurse Eppler, that R34 had the slide board but was at risk for falls because she did not always use it?  Or does it support DON Smith’s testimony that R34 was not provided the slide board because it was not safe to use?

Whatever the truth may be, Petitioner has no documentation that it provided an assistive device (slide board) based on the August 2019 physician order or that PT or OT timely evaluated and rejected that device.  Because R34 fell on December 21, 2019, while trying, unassisted, to get into her wheelchair from her bed before there was an order for a trapeze bar, the failure to provide the slide board or another assistive device shows a significant failure on Petitioner’s part.  CMS Ex. 9 at 22; see also Tr. 37; CMS Ex. 9 at 26 (R34 was found on the floor beside her bed); P. Ex. 5 at 12 (same).  There is no mention of the slide board in the documentation concerning this fall.  Further, while an October 17, 2019, MDS assessment indicated that R34 only needed supervision and set up assistance for transfers between surfaces (e.g., bed, chair, wheelchair, standing position) (CMS Ex. 8 at 18, 21), R34 told staff that the December 21 fall was caused by R34 forgetting to lock the wheels of the wheelchair before she attempted the transfer alone.  CMS Ex. 9 at 26; P. Ex. 5 at 12.  Therefore, I conclude that Petitioner failed to provide an assistive device to R34 that had been ordered by a physician, and R34 did not receive sufficient supervision/set up for a transfer.

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Following the December 21, 2019 fall, Petitioner did not take immediate action to provide interventions in the care plan’s “Falls” entry.  However, on December 30, 2019, a nurse practitioner ordered a trapeze bar to assist R34 in transfers.  CMS Ex. 9 at 50; P. Ex. 5 at 9.  The purpose of the trapeze bar was for R34 to use her upper body strength to independently move from the bed to her wheelchair.  Tr. 62.

R34 fell two days later on January 1, 2020, while attempting to transfer independently from her bed to the wheelchair.  There is no evidence that the trapeze bar was installed in R34’s room by that time.  CMS Ex. 9 at 21, 27, 34; P. Ex. 5 at 8; see also Tr. 37.

Despite two falls that occurred in the same manner, Petitioner waited until January 14, 2020, to finally add interventions to the care plan’s entry for “Falls.”  CMS Ex. 9 at 90.  Also on January 14, 2020, facility staff added an entry in R34’s care plan for “Visual Function” because R34 was “[a]t risk for injury d/t impaired vision.”  CMS Ex. 9 at 65.

It is unclear whether Petitioner implemented the care plan interventions when, on January 22, 2020, R34 fell in her room while trying to transfer from the bed to the wheelchair by herself.  CMS Ex. 9 at 42, 58; P. Ex. 5 at 1; see also Tr. 37-38.

LPN Gilbreath testified that the following interventions were implemented for R34 to avoid falls:  make sure she had adequate lighting, make her room ordered so she could see and easily access items she used most often, monitoring of wearing oxygen, reviewing her medication, and assessing her for postural/orthostatic hypotension.  P. Ex. 38 at 4.  DON Smith testified that the interventions to reduce R34’s risk of falls included placing a trapeze bar to assist with transfers, reminding her every shift to wear oxygen at all times, educating R34 to use the call light for transfers, and reminding R34 that she should not fall asleep in the wheelchair.  P. Ex. 32 ¶ 60.  However, as mentioned above, these interventions were only available to potentially stop the third fall.

DON Smith testified that R34 would verbalize understanding of education and instruction provided to her and then not comply with it.  P. Ex. 32 ¶ 61.  As a result, DON Smith concluded that “the reason for her falls were her attempts to transfer without asking for assistance (despite reminders to do so).”  P. Ex. 32 ¶ 62.  The record supports DON Smith’s conclusion.  However, in addition to ensuring that R34 had assistive devices, Petitioner also had the duty to supervise R34 better once staff became aware that R34 would attempt unsafe independent transfers.  The January 14, 2020 care plan interventions included increasing staff supervision with intensity based on resident need and providing individualized interventions based on needs/patterns.  CMS Ex. 9 at 90.  R34 needed additional supervision, but there is no record that this was provided by the January 22, 2020 fall.  Therefore, I conclude that Petitioner failed to provide adequate supervision and assistive devices to R34 to prevent accidental falls.  Those falls had a risk of more than minimal harm.

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Based on the foregoing, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(2) based on the facts involving R28, R34, and R41.

5. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d)(2) posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  The regulation does not require that a resident actually be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).

I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2).  The “clearly erroneous” standard imposes on facilities a heavy burden to show no immediate jeopardy, and administrative appellate cases have sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  See, e.g., Barbourville Nursing Home, DAB No. 1962 at 11 (2005) (quoting Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  In reviewing CMS’s finding, I “must consider whether the totality of the allegations support the Agency’s determination that [the SNF’s] noncompliance ‘has caused, or [was] likely to cause, serious injury, harm, impairment, or death to a resident.’”  Rosewood Care Ctr., 868 F.3d 605, 618 (7th Cir. 2017) (emphasis omitted).

CMS contends that Petitioner’s failure to provide adequate supervision and assistive devices created an environment likely to cause serious injury or impairment to its residents.  To support this contention, CMS argues that R41 had four falls within a two- week period, and two of the falls resulted in R41 fracturing bones.  CMS attributes this to Petitioner’s failure to assess the efficacy of current interventions and evaluate what new preventative measures could be put in place.  CMS Br. at 25; CMS Reply at 15.

Petitioner argues that CMS “has offered no evidence, that various falls . . . were caused by the [Petitioner], much less by noncompliance.”  P. Br. at 32.

My review of the record cannot support a conclusion that CMS’s immediate jeopardy determination is clearly erroneous.  As stated above, Petitioner bears the burden of showing this and Petitioner made little effort to do so.  One can readily understand why.

As CMS asserts, R41 suffered multiple falls within a short time.  As explained above, R41 was severely cognitively impaired and unable to follow warnings not to walk unassisted, and Petitioner did not comply with the care plan and increase supervision

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based on R41’s deteriorating condition.  After R41’s first fall that resulted in lacerations, Petitioner did not take action to increase supervision, resulting in a second fall and a fractured hip that required surgery.  DON Smith’s testimony connected the placement of R41 on hospice care with R41’s period of increased falls, noting that her first fall came about two months before R41 died.  P. Ex. 32 ¶¶ 19, 22.  DON Smith acknowledged that R41 fell several times but said “that most of the falls did not involve any serious injury, and for the two that did, EMS was immediately called, and [R41] was transported to the hospital.”  P. Ex. 32 ¶ 32.  However, DON Smith admitted that, following the second fall, which resulted in the fractured hip, R41 was placed on hospice care.  P. Ex. 32 ¶¶ 26, 33.  This is not to say that the fall was solely was responsible for the placement on hospice care, but the timing indicates there is some connection between the two events.

DON Smith also admitted that R41 sustained six falls within a seven-week period, and two of the falls resulted in bone fractures.  Tr. 30-31.  The last of those six falls was when R41 sustained a fractured bone in her arm.  As found above, all of these falls can be directly traced to Petitioner’s failure to implement the care plan intervention on supervision and a failure to evaluate the implementation of new interventions.  Even if one were to consider just the two falls that resulted in fractures, that is enough to show that Petitioner’s noncompliance caused serious injury, harm, and impairment for R41.  The other falls, however, did present a likelihood for similar serious injury and harm.

In addition, Petitioner’s lack of attention to R41 resulted in Petitioner’s failure to comply with orders from the hospital following surgery to repair her hip from the first fall.  Although the January 17, 2020 discharge summary from the hospital warned Petitioner to send R41 directly to the ER if she fell during the next 30 days while she was receiving the blood thinning medication Eliquis (CMS Ex. 7 at 108), there is no evidence that this happened after the January 29, January 30, or February 1, 2020 falls.

R28 also suffered six falls, all within a few months.  Significantly, R28 came to the facility to recover from a previous fall that had fractured her clavicle.  Petitioner did not assess R28 for fall risks or create care plan interventions quickly after admission, and R28 fell before the assessment was made and a care plan was created.  Most of the falls did not result in injuries.  However, DON Smith acknowledged that R28’s second fall outside on December 2, 2019 (but third fall at the facility) was serious because EMS transported R28 to the hospital.  Tr. 33.  Further, DON Smith acknowledged that R28 hit her head during the first fall.  Tr. 32-33.  As explained above, Petitioner failed to create and implement interventions to ensure that R28 was supervised when walking.  She was 96 years old and had a fractured clavicle.  These falls were likely to cause serious injury, harm, or impairment given her age and the possibility of further injuring her clavicle.

Finally, R34 fell three times within a relatively short period.  Petitioner failed to provide an assistive device ordered by a physician to avoid falls while transferring between bed

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and wheelchair.  While R34 never suffered significant injuries from her falls, this does not lessen the likelihood of falls to cause significant injury or harm.

Therefore, I conclude that CMS’s determination that Petitioner immediately jeopardized the health and safety of R28, R34, and R41 is not clearly erroneous.

Food Preparation for Individual Needs - 42 C.F.R. § 483.60(d)(3)

6. R94 was a 60-year-old resident with severe cognitive impairment, a recent history of pneumonia, and no teeth.  On admission to Petitioner’s facility, a physician ordered a mechanical soft diet and chopped meats for R94.  Similarly, R94’s care plan required a mechanical soft diet with chopped meats, and warned there was a risk of choking and aspiration.  Petitioner’s staff considered R94 capable of independently eating despite R94’s practice of “shoveling” food into his mouth.  On February 17, 2020, R94 choked during a meal.  Staff responded and removed pieces of scalloped potatoes from his airway.  EMS took R94 to the ER.  The ER concluded that R94 had aspiration pneumonia and arranged for R94 to be admitted to a hospital’s ICU.  A facility report following the choking incident indicated that R94 would now be supervised while eating meals and that staff would verify that the meal was correct for R94’s diet.

R94 was admitted to Petitioner’s facility on January 31, 2020, from another facility.  P. Ex. 9; CMS Ex. 10 at 3-4.  R94 was a 60-year-old man diagnosed with:  Down syndrome; vascular dementia without behavioral disturbance; unspecified dementia; and unspecified systolic (congestive) heart failure.  CMS Ex. 10 at 4.  R94 had no teeth and wore no dentures.  CMS Ex. 10 at 2.  A 2017 Speech-Language Pathologist (SLP) assessment stated:  “No problems were observed or reported on his current diet (chopped to 1”) but his jaw movement is minimal for chewing.”  P. Ex. 11 at 3.

Prior to admission to Petitioner’s facility, on January 23, 2020, R94 was admitted to a hospital due to shortness of breath with fever.  P. Ex. 12 at 4.  The Admission History and Physical stated that R94 had been recently hospitalized for pneumonia and acute hypoxic respiratory failure.  P. Ex. 12 at 4.  A physician assessed R94 as having healthcare associated pneumonia, acute cystitis, sepsis secondary to pneumonia, and acute hypoxic respiratory failure.  P. Ex. 12 at 9.

On January 24, 2020, an SLP at the hospital evaluated R94 and found the following:  “[R94] demonstrates functional oral and pharyngeal swallow.  [History] of esophageal dysphagia.  [R94] is endentulous.  Recommend soft dental diet, chopped meats, thin liquids.  Esophageal swallow precautions.”  P. Ex. 13 at 3.  The SLP identified the following precautions:  “sit upright for all intake”; “small bites/sips”; “supervision with meals”; and “sit upright 30-45 min after meals.”  P. Ex. 13 at 4.

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Consistent with this assessment, on January 31, 2020, the day R94 was admitted to Petitioner’s facility, a physician ordered the following for R94:  “Diet:  mech soft, chopped meats.”  P. Ex. 10; CMS Ex. 10 at 4; CMS Ex. 11 at 3.  The physician also ordered R94’s medications to be “crushed or capsules may be opened and administered with pudding or applesauce or as indicated.”  P. Ex. 10; CMS Ex. 10 at 4.
On February 12, 2020, Petitioner’s staff performed an MDS assessment for R94.  CMS Ex. 10 at 5.  The assessment indicated that R94 had an intellectual disability and severely impaired cognitive skills.  CMS Ex. 10 at 6-7.  Although the functional status assessment indicated that R94 needed extensive assistance from a staff member to help him with most activities of daily living, the assessment rated R94 as independent with eating and required “[s]etup help only.”  CMS Ex. 10 at 8.  The MDS assessment noted that R94 did not have any teeth, needed a mechanically altered diet (i.e., “require change in texture of food or liquids”), and did not have a swallowing disorder.  CMS Ex. 10 at 9-10.

On February 13, 2020, Petitioner’s staff added a care plan entry for “Nutritional Status” that noted R94 “requires a diet of mech soft with chopped meats and is at risk for weight loss and choking/aspiration.”  CMS Ex. 10 at 1.  This entry’s interventions included:  allowing R94 extra time to eat; assisting R94 to eat if he became unable to eat; monitoring his intake at meals; and “Diet as ordered by physician.”  CMS Ex. 10 at 1.

A February 17, 2020 rogress note entered by a LPN at 12:10 p.m. stated:

Was called to dining room, [R94] appeared to be choking on food, 2 staff member stood resident up, while this nurse started Heimlich Maneuver, 5 abdominal thrusts completed, crash cart brought to dining room was able to suction parts of potatoes from resident mouth.  Resident able to breath[e] but some portions of food still lodge[d], EMS arrived during suctioning and transported resident to EMS.

CMS Ex. 10 at 3; see also P. Ex. 14 at 1.

The February 17, 2020 Clinical Report from the ER physician stated that R94’s chief complaint was moderate shortness of breath (i.e., dyspnea) that “started just prior to arrival.”  CMS Ex. 10 at 11.  The physician recorded that “Nursing home staff states that the patient aspirated on a potato prior to arrival and is still present,” and R94 “has had sputum production, a cough and chest pain.”  CMS Ex. 10 at 11.  The ER physician described R94 as in “mild distress,” and noted that “Respiratory distress [is] present.  Moderately decreased air movement in the right lung.”  CMS Ex. 10 at 11.

Due to R94’s shortness of breath, the ER ordered an X-ray taken on February 17, 2020, which revealed that R94 had bilateral lower lobe pneumonia.  CMS Ex. 10 at 13, 20.  The

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ER physician’s clinical impression was “Aspiration Pneumonia, Acute Hypoxic respiratory failure, Adrenal insufficiency.”  CMS Ex. 10 at 14, 16.  The ER physician arranged for R94 to be admitted to the ICU of a hospital because “higher level of care” was needed.  CMS Ex. 10 at 13, 16-17.  The ER physician required R94 to be transported from the ER to the hospital’s ICU in an ambulance noting that R94 “[r]equires airway monitoring or suctioning” and “continuous oxygen [and] monitoring by trained staff.”  CMS Ex. 10 at 18.  The ER physician stated that death could be expected if R94 were transported by any means other than an ambulance.  CMS Ex. 10 at 19.

In a February 20, 2020 Event Report, the facility noted that, on February 17, 2020, R94 “choked during meal in dining room.”  P. Ex. 14 at 1.  The report stated:  “Staff to supervise all meals.  Staff to verify correct diet [served] at all meals.”  P. Ex. 14 at 1.

On February 22, 2020, R94 was discharged from the hospital and returned to Petitioner’s facility.  P. Ex. 14 at 1; P. Ex. 15 at 3.  The hospital discharge stated that R94 had an “acute episode of hypoxia after [a] choking spell.”  P. Ex. 15 at 3.

Petitioner’s staff noted that R94 returned to the facility after being hospitalized for aspiration pneumonia.  P. Ex. 14 at 1.  After R94 returned, the facility documented that staff supervised and assisted R94 at meals to prevent choking until the end of June 2020; however, that supervision and assistance was to continue beyond June.  P. Ex. 14 at 1-2. 

7. Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(d)(3) because it did not provide food prepared for R94’s individual needs.

The Social Security Act states:  “To the extent needed to fulfill all plans of care . . . a skilled nursing facility must provide . . . dietary services that assure that the meals meet the . . . special dietary needs of each resident.”  42 U.S.C. § 1395i-3(b)(4)(A)(iv).  The implementing regulations require SNFs to provide each resident with food and drink that meet the “special dietary needs” of the resident and for each resident to receive “[f]ood prepared in a form designed to meet individual needs.”  42 C.F.R. § 483.60(d)(3).

Consistent with a physician order and an SLP assessment, R94’s care plan required food to be mechanically soft and for meat to be chopped.  CMS Ex. 10 at 1; P. Ex. 10; P. Ex. 13 at 3.  “A ‘mechanical soft’ diet consists of food that has been altered in texture to make it easier to swallow.  Mechanical soft food may include pureed food, but it may also include chopped or ground food.”  Kingsville Nursing & Rehab. Ctr., DAB No. CR6212 at 3 (2023).  “Pureed food is prepared in a blender.  In contrast, a ‘mechanical soft’ diet can include . . . meats that require some chewing but are ground or well cooked to make chewing them easier.”  Rehab at River’s Edge, DAB No. 3163 at 3 (2024).

Further, Petitioner’s food policy required food trays to be checked for correct “diet order” and “[s]pecial requests” before providing them to each resident.  CMS Ex. 14 at 7-8.

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During cross-examination, DON Smith agreed that the meal involved in R94’s choking incident included scalloped potatoes and that staff successfully suctioned pieces of potato from R94’s mouth.  Tr. 45-46.  DON Smith agreed that R94 required soft foods and that soft foods means tender and soft, and not hard.  Tr. 44.  DON Smith also agreed that mashed potatoes would be considered soft but undercooked potatoes would perhaps not be considered soft.  Tr. 45.  She further agreed that undercooked potatoes would not be consistent with a soft mechanical diet.  Tr. 45.  Finally, DON Smith agreed that R94 coughed up three pieces of scalloped potatoes and not mashed potatoes.  Tr. 47.

Petitioner disputes that the scalloped potatoes, as provided to R94, contravened the care plan’s requirement for mechanical soft food.  P. Br. at 24-25.  Rather, Petitioner asserts that R94’s method of eating caused the choking incident.  P. Br. at 25.

In support of Petitioner’s position, DON Smith and Nurse Eppler testified that there is no evidence that R94’s diet was not appropriately modified because R94 did not choke until his last bite.  P. Ex. 32 ¶¶ 96, 102; P. Ex. 33 at 10.  Further, they testified that the surveyors did not observe the choking incident and improperly relied on the statements of three residents with mental deficiencies who said that the scalloped potatoes were uncooked that day.  P. Ex. 32 ¶¶ 97-98; P. Ex. 33 at 10; Tr. 70-71.  DON Smith testified that she conducted an investigation and questioned the food preparation staff, who did not admit to improperly preparing the food for R94.  Tr. 69.

The evidence of record is sufficient to conclude that CMS made a prima facie case that Petitioner failed to provide R94 with food that met his dietary restrictions.  R94 choked on scalloped potatoes that staff could only partially remove from his airway.  Scalloped potatoes are not necessarily mechanically softened like mashed potatoes, and the survey found no evidence that the ones served to R94 had been mechanically softened.  See Century Care of Crystal Coast, DAB CR1488 (2006) (upholding a deficiency because a resident was served shredded meat, instead of ground meat, as ordered by a physician).

As explained above, once CMS has come forward with evidence sufficient to establish a prima facie case that it had a legally sufficient basis for imposing remedies, the SNF has the ultimate burden of persuasion and must prove, by a preponderance of the evidence, that it is in substantial compliance with the relevant statutory and regulatory provisions.  Hillman Rehab. Ctr., DAB No. 1611 at 8 (1997), aff’d, Hillman Rehab. Ctr. v. U.S. Dep’t of Health and Human Servs., No. Civ.A. 98-3789 (GEB) 1999 WL 34813783 (D.N.J. May 13, 1999).

Petitioner did not provide any contemporaneous documentation or witness testimony from individuals who were present when R94 choked to confirm that the scalloped potatoes were mechanically softened as required by his care plan and a physician order.  DON Smith and Nurse Eppler state in their testimony that there is no evidence that

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Petitioner failed to provide R94 with food that was properly prepared for him; however, neither witnessed the choking incident (P. Ex. 33 at 9; Tr. 44), and such statements do not aid Petitioner in meeting its burden.  Further, the facility’s menu for February 17, 2020, indicates that the scalloped potatoes were on the regular menu and not modified to be served as a mechanically softened option.  See CMS Ex. 12 at 13 (Monday noon meal).  Therefore, Petitioner’s staff had to specifically soften those potatoes for R94.
As mentioned earlier, DON Smith testified that she investigated the choking incident and found that R94’s food had been mechanically softened.  However, her investigation seems to have been extremely limited:

Q:  What did you do to determine whether there was a problem with the preparation of this resident’s meal?  Do interviews, look at the meal cards, all that stuff?

A:  I just asked the questions and checked with the dietary people, and other residents.

Q:  What did they tell you?  Did they tell you it was – did they admit to any problem?

A:  No.

Tr. 69.

I do not give weight to this testimony from DON Smith.  There is no documentation of this alleged investigation in the record and she did not mention it in her written direct testimony.  Further, if she did conduct one, DON Smith’s responses to questions, quoted above, fail to convince me that her investigation was thorough and complete.  When asked whether she conducted interviews and checked meal cards, she vaguely responded that she just asked some people some questions.  And the fact that no one admitted to any problems with the food provided to R94 is far from dispositive.

The only documentation of an inquiry into the choking incident is the Event Report, which was created and closed by staff members other than DON Smith.  This report recounts the choking incident in the same manner as R94’s progress notes, which does not state that the potatoes had been mechanically softened.  Significantly, the Event Report provides instructions for the future:  “Staff to supervise at all meals.  Staff to verify correct diet [served] at all meals.”  P. Ex. 14 at 1.

I find the explicit requirement that staff are to verify that the correct diet is being served to R94 as indicative that Petitioner’s inquiry was unable to confirm that R94’s meal had been mechanically softened as required by the care plan.  After all, staff were already required to check the meal as a normal precaution.  CMS Ex. 14 at 7-8.  Stating this as a

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future expectation in the Event Report shows that Petitioner’s staff had to be affirmatively reminded to check the food being served to R94.  This notation is particularly suggestive given that Petitioner was unable to provide any evidence that, on February 17, 2020, Petitioner checked R94’s meal before it was served, and that R94’s scalloped potatoes were mechanically softened.

Finally, Nurse Eppler testified that Petitioner’s staff retrieved “dime sized” pieces of potato, which she states is the appropriate size for the potato that should have been provided to him.  P. Ex. 33 at 9.  The implication is that these “dime sized” pieces prove compliance.  However, I do not accept Nurse Eppler’s position.  DON Smith testified that, despite not having teeth, R94 could and did chew his food.  Tr. 46.  DON Smith also testified that nursing notes indicated that R94 would “shovel” his food when eating, but staff monitored R94 closely and R94 seemed to be able to eat safely that way.  P. Ex. 32 ¶¶ 89-90, 114; Tr. 44-45.  Therefore, even if a coin sized piece of potato was sufficient to meet the care plan’s requirement for mechanical soft food, I cannot assume that the potato slices were originally that small.  Because Nurse Eppler’s testimony is speculative, it does not satisfy Petitioner’s burden to show that the facility provided R94 with mechanically soft potatoes.

Therefore, I conclude that Petitioner was not in substantial compliance with 42 C.F.R. § 483.60(d)(3) because Petitioner failed to provide R94 with food that met his individual and special dietary needs, as expressed in R94’s care plan, and that failure created a risk for more than minimal harm to R94.

8. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.60(d)(3) posed immediate jeopardy to resident health and safety is not clearly erroneous.

As stated above, immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  The regulation does not require that a resident actually be harmed.  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 8 (2012).  Further, I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c)(2).

CMS argues that its immediate jeopardy determination is correct because R94 required hospitalization in an intensive care facility after choking.  CMS Br. at 25; CMS Reply at 15-16.  In response, Petitioner argues that there is no evidence that Petitioner caused R94’s choking incident.  P. Br. at 32.

Petitioner is incorrect.  Its noncompliance caused R94 to choke.

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Petitioner’s staff documented the choking incident and documented that facility staff were able to save R94 from choking by using the Heimlich Maneuver and suction to remove parts of potato from R94’s mouth, allowing him to breathe.  However, some of the potato remained lodged in his mouth when EMS arrived to take R94 to the ER.  CMS Ex. 10 at 3; see also P. Ex. 14 at 1.

Choking and the loss of oxygen is likely to cause serious harm or death unless the obstruction is removed.  However, in a resident like R94, merely removing the obstruction does not ensure that he would not die or be otherwise seriously harmed.

DON Smith admitted in her testimony that R94 was sent to the hospital following the choking incident and was diagnosed with aspirational pneumonia.  P. Ex. 32 ¶ 94.  DON Smith testified that aspirational pneumonia is caused by a foreign substance getting into the lungs.  Tr. 66.  However, DON Smith also testified that it was unavoidable for R94 to get aspirational pneumonia because he had Down syndrome, had no teeth, an enlarged tongue, and he “shoveled” food into his mouth.  Tr. 66-67.  Finally, DON Smith testified that R94’s history of hospitalization before the choking incident showed he already had pneumonia diagnoses, and his discharge diagnoses from the hospital following the choking incident were similar to the diagnoses from his previous hospital admissions.  P. Ex. 32 ¶¶ 107-113.

The increased likelihood of R94 aspirating due to his various physical and mental limitations along with R94’s recent history of hospitalization for pneumonia should have resulted in Petitioner having a heightened concern that R94 not choke and aspirate due to the food provided to him.  In this case, R94 not only was subject to the likelihood of serious injury or harm, or death, from choking on potatoes, but the physician at the ER was sufficiently concerned that he arranged for R94 to be admitted to the ICU of a hospital because “higher level of care” was needed.  CMS Ex. 10 at 13, 16-17.  R94’s situation was so precarious that the ER physician certified that R94 would be expected to die if he was not transported to the ICU by ambulance, which allowed staff to monitor his airway and suction when needed and provide continuous oxygen.  CMS Ex. 10 at 18-19.  Finally, the significant harm and danger posed to R94 based on the choking incident is also shown by the fact that R94 remained in the hospital for five days.  P. Ex. 15.

Therefore, I conclude that CMS’s determination that Petitioner immediately jeopardized the health and safety of R94 is not clearly erroneous.

Other Alleged Deficiencies and Remedy

9. I need not decide whether Petitioner was in substantial compliance with any of the other deficiencies alleged in the SOD because the deficiencies adjudicated above are more than sufficient to justify the relatively modest remedy that CMS imposed.

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The SOD in this case alleged many deficiencies.  However, CMS identified two deficiencies that were at the immediate jeopardy level.  Above, I have fully considered and upheld the immediate jeopardy citations.  As seen from the detailed findings for those citations, those deficiencies involved situations where four residents were subjected to both actual and likely significant harm, injury, impairment, and death.  R41 was placed on hospice upon her return from hip surgery following a fall, and R94 was sufficiently close to death that the ER physician certified that he would die unless transported to the ICU in an ambulance where his airway could be monitored and suctioned and he was provided with continuous oxygen.  Further, a pattern was established where Petitioner’s staff either would not follow the interventions in the residents’ care plans or would not initially complete or later update care plans.  There is no doubt that the modest CMPs imposed in this case are more than supported based on the deficiencies at 42 C.F.R. §§ 483.25(d)(2) and 483.60(d)(3).

I note that the $14,300 per-day CMP for four days is almost exactly in the middle of the applicable penalty range ($6,808 to $22,320) for immediate jeopardy deficiencies. 45 C.F.R. § 102.3 (2020).  Therefore, this amount is far from the maximum that could have been imposed.  Further, the $1,300 per-day CMP for 19 days of non-immediate jeopardy level deficiencies is on the lower end of the penalty range ($112 to $6,695).6  45 C.F.R. § 102.3 (2020).

An ALJ need not consider all of the deficiencies cited, so long as the deficiencies he or she affirms support the penalties imposed.  Perry Cnty. Nursing Ctr. v. U.S. Dep’t of Health & Human Services, 603 F. App’x 265, 271 (5th Cir. 2015) (agreeing that the regulations require ALJs to review only those findings that are material to the outcome of a case); Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010); Rockcastle Health and Rehab. Ctr., DAB No. 2891 at 23-24 (2018); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 6 n.5 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010).  Therefore, I do not need to adjudicate any of the other lower-level deficiencies alleged in this case.

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10. The amount and duration of the $14,300 per-day CMP imposed for four days and the $1,300 per-day CMP imposed for 19 days were not challenged and are, therefore, reasonable.

CMS imposed on Petitioner a $14,300 per-day CMP for four days and a $1,300 per-day CMP for 19 days.  CMS Ex. 1 at 2.  Petitioner disputed the deficiencies underlying the imposition of this remedy as well as the findings of immediate jeopardy.  Except for two conclusory sentences in its request for hearing, Petitioner did not challenge the CMP amounts or duration.

An SNF bears the burden of showing that its noncompliance was of shorter duration than alleged by CMS.  Owensboro Place & Rehab. Ctr., DAB No. 2397 at 12 (2011) (citing Kenton Healthcare, LLC, DAB No. 2186 at 24-25 (2008); Lake Mary Health Care, DAB No. 2081 at 30 (2007)).  Petitioner made no attempt to show the duration of the CMP should be shorter.  Therefore, I accept the duration as found by CMS.

When determining whether a CMP amount is reasonable, I am to apply the factors listed in 42 C.F.R. § 488.438(f).  The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the ALJ, requiring only that the regulatory factors at 42 C.F.R. §§ 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), (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  There is a “presumption that CMS has considered the regulatory factors in setting” the CMP amount and that those factors support the CMP.  Unless a facility contends that a particular regulatory factor does not support the CMP amount, an ALJ must sustain it.  Coquina Ctr., DAB No. 1860 at 32 (2002).

An SNF may appeal the amount and duration of a CMP.  42 C.F.R. §§ 488.438(e), 498.3(b)(13).  In its post-hearing brief, however, Petitioner did not dispute the amount or duration of the CMP.  Tr. 89; July 15, 2022 Notice of Receipt of Transcript and Post-Hearing Briefing Schedule at 1 (requiring parties to identify all issues in the post-hearing briefs that they want me to address).  Therefore, I uphold the CMP amounts imposed by CMS.

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VI.     Conclusion

For the reasons set forth above, I sustain CMS’s determination that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.25(d)(2) and 483.60(d)(3), and that the noncompliance immediately jeopardized the health and safety of residents.  Petitioner did not challenge the amount and duration of the CMP; therefore, I uphold the CMP imposed on Petitioner.