Advanced Center for Nursing and Rehabilitation, DAB CR6618 (2025)

DECISION

Advanced Center for Nursing & Rehabilitation (Petitioner or the facility) is a skilled nursing facility located in New Haven, Connecticut, that participates in the Medicare program.  On December 22, 2022, Petitioner was notified by the Centers for Medicare and Medicaid Services (CMS) that, based on an inspection by the Connecticut Department of Public Health, Facility Licensing & Investigation (State Survey Agency), it was found, as relevant herein, to be out of compliance with 42 C.F.R. § 483.25, quality of care, Tag F0684 and 42 C.F.R. § 483.25(d)(1)(2), Free of Accident Hazards/Supervision/Devices, Tag F0689, at the immediate jeopardy level.1  CMS

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Exhibit (Ex.) 2 at 1-2.  For that noncompliance, CMS ultimately imposed a $7,445.00 per-day civil money penalty (CMP) for five days, beginning March 23, 2022, and continuing through March 27, 2022, and a CMP of $360.00 per day for 38 days, from March 28, 2022 through May 4, 2022, for a total CMP of $40,724.00.2  Id. at 8.  Petitioner filed a timely Request for Hearing (RH) on February 17, 2023.3

I.    Background

The Social Security Act (Act) sets forth requirements for nursing facility participation in the Medicare program and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.  To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities are in substantial compliance with program participation requirements.  Act § 1864(a); 42 C.F.R. § 488.20.  The regulations require that each facility be surveyed once every 12 months, and more often, if necessary, to

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ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.

In this case, a complaint investigation survey of the facility was conducted from March 21, 2022 through March 24, 2022.  CMS Ex. 1 at 1.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs, and a deficiency existed which posed immediate jeopardy to resident health and safety.  CMS Ex. 2.  Specifically, as relevant herein, it found that the facility did not meet federal requirements under 42 C.F.R. § 483.25 (Tag F0684 -- Quality of Care) and 42 C.F.R. § 483.25(d)(1)(2) (Tag F0689 -- Free of Accident Hazards/Supervision/Devices).  CMS Ex. 2 at 7-8.  
Petitioner timely requested a hearing. 

On February 21, 2023, Judge Leslie A. Weyn issued a Standing Prehearing Order, setting forth prehearing procedures.4  Both parties filed their prehearing exchanges, including prehearing briefs (CMS PH Br. and P. PH Br.).  With its brief, CMS submitted 14 proposed exhibits, including the written direct testimony of one witness.  CMS Exhibits (Exs.) 1-14.  Petitioner submitted nine proposed exhibits, including the written direct testimony of four witnesses.  P. Exs. 1-9. 

Petitioner filed objections to the surveyor notes contained in CMS Exhibits 8 and 9 on the basis that they involved hearsay and were inherently unreliable.  Petitioner also filed a request to cross-examine the witness proposed by CMS and a request for subpoenas to be issued for the three surveyors who conducted the survey.  CMS filed an objection to Petitioner’s request for subpoenas and filed a request to cross-examine the four witnesses proposed by Petitioner.

I held a prehearing conference in this matter on June 10, 2024.  At the prehearing conference, Petitioner withdrew its objections to CMS Exhibits 8 and 9 and its subpoena requests.  Petitioner confirmed its request to cross-examine the proposed witness of CMS, whose declaration is contained in CMS Ex. 14.  CMS amended its request to cross-examine and sought only to cross-examine Marley West, R.N., whose declaration is contained in P. Ex. 5.  As a result, I admitted CMS Exhibits 1-14 and Petitioner Exhibits 1-9 into the record, with the exception of CMS Exhibit 14 and Petitioner Exhibit 5, which were provisionally admitted, subject to authentication at the hearing.  On August 5, 2024, Petitioner withdrew its request to cross-examine the witness of CMS.

A hearing was held in this matter on August 7, 2024.  On September 13, 2024, I notified the parties that the transcription of the hearing had been received and established a schedule for post-hearing briefs.  Both parties submitted post-hearing briefs (CMS PO Br. and P. PO Br.) on November 19, 2024.

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II.    Issues

1)  Whether the facility was in substantial compliance with 42 C.F.R. §§ 483.25 and 483.25(d)(1)(2);

2)  If the facility was not in substantial compliance with 42 C.F.R. §§ 483.25 and 483.25(d)(1)(2), whether CMS’s determination that the noncompliance immediately jeopardized the health and safety of the facility’s residents was clearly erroneous; and

3)  If the facility was not in substantial compliance, whether the penalty amounts imposed are reasonable.

III.    Discussion5

1. Petitioner was in substantial compliance with 42 C.F.R § 483.25.

Program requirement:  42 C.F.R. § 483.25 (Tag F684).  The statute mandates that the facility ensure that each resident receive, and the facility provide, the necessary care and services to allow the resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident’s comprehensive assessment and plan of care.  Act § 1819(b)(2).

The quality-of-care regulation characterizes quality of care as a “fundamental principle that applies to all treatment and care provided to facility residents.”  Based on the resident’s comprehensive assessment, the facility must ensure that the resident receives treatment and care in accordance with professional standards of practice, the resident’s comprehensive, person-centered care plan, and the resident’s choices.  42 C.F.R. § 483.25.  The regulation “imposes on facilities an affirmative duty designed to achieve favorable outcomes to the highest practicable degree.”  Sheridan Health Care Ctr., DAB No. 2178 at 14 (2008) (citing Windsor Health Care Ctr., DAB No. 1902 at 16-17 (2003)); Woodstock Care Ctr., DAB No. 1726 at 3-4 (2000), aff’d, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).

Resident # 4 (R4) was admitted to the facility on February 6, 2022, following a hospital stay from January 31, 2022 through February 6, 2022.  CMS Ex. 8 at 1.  He had a past medical history of chronic alcohol abuse, depression, diabetes mellitus, and substance abuse, on methadone.  Id. at 140.  According to the Discharge Summary from the hospitalization, R4 was admitted after being found when his medical alert alarm went off

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after a fall.  He was treated for rib and sternal fractures, remote cerebral vascular accident, and episodes of hypoglycemia down into the 30s.  Nightly Lantus insulin was discontinued.  Id. at 136.

Because of his hypoglycemia, R4 was evaluated by the Diabetes Management Team on February 6, 2022.  CMS Ex. 8 at 185.  At the conclusion of the evaluation, it was noted that R4 was hyperglycemic that morning and starting Lantus at a low dose was advised.  Id. at 186.  Recommendations from the evaluation were to:

1. Start Lantus 5 units QHS
2. Continue with Metformin and Linagliptin at current doses
3. Continue lispro LOW dose sliding scale AC TID
4. Continue lispro LOW dose sliding scale qHS (Starting with a BG of 250)
5. Blood glucose monitoring AC TID & HS
6. Diet:  carb consistent

The consultant’s report further indicated that “[a]ll recommendations were conveyed via direct contact with the covering provider or MHB.”  CMS Ex. 8 at 186.

R4 was discharged on February 6, 2022 with Encounter Diagnoses of fall against object, closed fracture of multiple ribs, and Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin.  CMS Ex. 8 at 135.  Discharge medications included insulin glargine (Semglee, Lantus) 100 unit/mL, inject 5 Units under the skin daily, and Sitagliptin-metformin (Janumet), one tablet by mouth daily.  Id. at 141-142.

On February 6, 2022, upon R4’s admission to the facility, physician’s orders included Accucheck BID (twice a day) at 9:00 AM and 9:00 PM.  CMS Ex. 8 at 35.  On February 7, 2022, physician’s orders for Janumet (sitagliptin-metformin) once a day at 9:00 AM, and Lantus Solostar U-100 Insulin subcutaneous, once a day at 9:00 PM were entered.  Id. at 38.  The resident received Janumet at 9:00 AM on February 7 and February 8, 2022, and Lantus SoloStar on February 7, 2022 at 9:00 PM.  Id. at 84-85.  Blood glucose readings were obtained as follows:  2/6 at 9:15 PM:  150 mg/dL; 2/7 at 9:33 AM:  142 mg/dL; 2/7 at 9:20 PM:  210 mg/dL; and 2/8 at 9:35 AM:  200 mg/dL.  Id. at 117.

On February 8, 2022 at 1:43 PM, an LPN observed that R4 was showing signs of a change in mental status from that morning.  He was observed to be short of breath, was started on oxygen, and sent to the ER.  CMS Ex. 8 at 69.

R4 was hospitalized from February 8, 2022 through February 15, 2022 with principal diagnosis of diabetic ketoacidosis.  CMS Ex. 8 at 150.  On admission, his FS glucose was over 600.  According to R4’s report, he had not been receiving insulin.  He was treated with insulin infusion with resolution of the acidosis.  Id. at 150-51.  Discharge

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medications included sliding scale insulin (SSI), three times a day before meals, and daily injections of Lantus.  Id. at 155.

CMS argues that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25 because it failed to incorporate the hospital recommendation for sliding scale insulin and failed to take appropriate action by notifying the provider when elevated blood glucose readings were recorded, resulting in a failure to follow applicable standards of practice for patients with a history of diabetic ketoacidosis (DKA).  CMS PH Br. at 22, CMS PO Br. at 23.  Petitioner argues that it did not violate applicable standards of practice in its care of R4 because it implemented the physician orders set forth in the Hospital Discharge Summary, which themselves did not adopt recommendations from the hospital diabetes consult, and the failure to notify the provider of blood sugars equal to or greater than 200mg/dl did not violate a standard of practice.  P. PH Br. at 9, P. PO Br. at 2.

Considering first the argument that the facility should have implemented the recommendations of the hospital diabetic consultants for sliding scale insulin, I find this recommendation was not in accordance with professional standards of practice.  There is no dispute that the facility effectuated the medication orders contained in the Hospital Discharge Summary and Hospital Transport Handoff.6  At the time of the discharge on February 6, 2022, a summary was prepared by Mahsa Shariat, M.D.  In the Discharge Summary, Dr. Shariat indicated the primary diagnosis was a fall but other diagnoses included Type 2 diabetes mellitus with hyperglycemia, with long term use of insulin.  CMS Ex. 8 at 135.  During the hospitalization, R4 was reported to have had episodes of hypoglycemia down to the 30s, at which point nightly Lantus insulin was discontinued.  Id. at 136.  Discharge medications to start included “insulin glargine (SEMGLEE, LANTUS) 100 unit/mL vial Inject 5 Units under the skin daily.  Qty:  10 mL, Refills:  2 Start date: 2/6/2022.”  Id. at 141.  The Discharge Report also contained the notation “Inpatient Consultants and summary of recommendations:  None.”  Id. at 136.

In the Hospital Transport Handoff, medications to start included “insulin glargine 100 unit/mL vial Commonly known as:  Semglee, Lantus Inject 5 Units under the skin daily.  Replaces:  Lantus Solostar U-100 Insulin 100 unit/mL (3 mL) pen” and “Janumet 50-1,000 mg per tablet Generic drug:  SITagliptin-metformin Take 1 tablet by mouth daily.”  CMS Ex. 8 at 170-71.  Dirk C. Johnson, M.D., the discharging attending physician, signed the Transport Handoff, indicating that he had seen, evaluated, and reviewed the findings and assessment by Drs. Aravind and Shariat and concurred with their

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documentation.  P. Ex. 2; CMS Ex. 8 at 135.  Facility Resident Progress Notes dated February 6, 2022 indicated that at 7:31 PM, “Medication reconciled -W-10 with PCP.”  CMS Ex. 8 at 78.  As noted above, on February 6, 2022, upon admission to the facility, physician’s orders included Accucheck BID (twice a day) at 9:00 AM and 9:00 PM.  Id. at 35.  On February 7, 2022, physician’s orders for Janumet (sitagliptin-metformin) once a day at 9:00 AM, and Lantus Solostar U-100 Insulin subcutaneous, once a day at 9:00 PM, were entered.  Id. at 38.

CMS’s position here is that the facility should have implemented the recommendation from the diabetic management consultation for sliding scale insulin.  While it is clear that a diabetic management consultation was done during the hospitalization on February 6, 2022 and one of the recommendations from that consult was for sliding scale insulin, it is also clear that this recommendation was not adopted by the physician doing the discharge report.  CMS Ex. 8 at 185-86, 141-42.  CMS argues, through its witness, that even if the consult summary was not attached to the discharge summary, “the facility nonetheless should have carefully reviewed the patient’s/resident’s hospital stay to have a clear understanding of the care needs required by medical professionals and thus ensure safe, quality of care.”  CMS Ex. 14 at 6.  What CMS suggests is that Petitioner, despite receiving medication orders in the Discharge Report from the hospital, in the Transport Handoff Report, and the facility’s physician’s order, should have looked past these orders and implemented a “recommendation” that was not adopted at the time of discharge.  Moreover, under CMS’s position, the facility would have had to read through the entire hospital record to find this recommendation since the front page of the discharge report (incorrectly) indicated there were no inpatient consultations or recommendations.  CMS Ex. 8 at 136.  CMS cites no authority or guidance documents as to when a facility may disregard physician’s orders and I am not aware of any such authority.  As such, I have given no weight to the opinion of Ms. Elkins, CMS’s expert witness, on this issue.

CMS then points to the statements reportedly made by Dr. Lazarides, the treating source at the facility, that “there should have been sliding scale insulin orders in place for Resident # 4, with blood glucose perimeters to direct staff when to notify the provider” and a provider should have been notified about the elevated blood sugar results that were obtained.  CMS Ex. 1 at 42.  The Summary Statement of Deficiencies (SOD) further indicated that Dr. Lazarides additionally stated that “a provider (MD or APRN) should have been notified for the elevated blood sugar results.”  Id.  There are two reasons why these statements in this summary are not given weight.  In the first place, it is not entirely consistent with the surveyor’s notes of her conversation with Dr. Lazarides, as discussed below.  Moreover, his statement that he was not sure why there was not an order for sliding scale insulin and, if the resident was a brittle diabetic, there should have been SSI orders, was given in hindsight after the second hospitalization on February 8, 2022.  Id.  It is notable that Dr. Lazarides, himself, did not order SSI or request notification with blood sugars over 200 in the admission orders he entered on February 7, 2022.  CMS Ex.

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8 at 38.  Therefore, I see no basis for finding a deficiency on the part of the facility for implementing the orders that were provided by three different physicians.

Ms. West testified that, upon admission, R4’s medications were reconciled with the W-10 (transport handoff) and PCP.  Tr. at 13.  In her declaration, she stated that it was “standard practice within the long-term care industry to rely on the Hospital Discharge/Summary/Interagency Report (W-10) for orders and recommendations when a patient is being admitted from the hospital to the SNF,” particularly with a new admission, where the SNF has no prior knowledge of the resident’s medical condition and has not yet done a full assessment and care plan.  P. Ex. 5 at 2.  In this case, the facility did rely on the above sources in order to provide R4 with the prescribed medication.

Perhaps recognizing the relative weakness of its position that the facility should have followed the recommendations of the in-patient diabetes consult, rather than the orders entered by physicians, CMS then asserts that the facility failed to take action when elevated blood glucose readings of 210 and 200 were recorded on February 7-8, 2022, which was further indicative of a failure to follow applicable standards of practice for patients with a history of DKA.  CMS PH Br. at 22.  Specifically, CMS asserts that “the resident’s physician was not notified at the time of either reading.”  Id.  However, the weight of the record does not support the argument that the failure to notify a physician after obtaining blood glucose readings of 210 and 200 was inconsistent with the applicable standards of care for R4.

In the SOD, CMS stated that MD# 1, Dr. Lazarides, told the surveyor that a provider “should have been notified for the elevated blood sugar results.”  CMS Ex. 1 at 42.  However, this statement is not consistent with the surveyor’s notes in CMS Exhibit 8 at 211.  In those notes, Dr. Lazarides reportedly stated that someone should be notified if blood sugar levels were at “400, 300, or 250,” none of which were reported in this case.  CMS Ex. 8 at 211.  Similarly, in his Declaration, William C. Hallett, Pharm.D., a geriatric pharmacist, stated that throughout his over 30 years of experience, facility policies generally dictate notification when blood sugars fall below 70 mg/dl or above 400 mg/dl, and occasionally, the high range was placed to 300 or 350 mg/dl, but he could not recall any instance in which notification was required for less than 300 mg/dl, let alone 200 mg/gl.  P. Ex. 7 at 2-3.  Consistent with these statements, Ms. West indicated in her declaration that she “would not expect nursing to notify a physician for a blood glucose reading at or slightly above 200mg/dl and this is not the standard of practice within the industry.  The standard practice would be to notify when blood sugars are below 70mg/dl or above 400mg/dl, absent specific orders to the contrary.”  P. Ex. 5 at 3.  As Dr. Hallett noted, “[i]ndeed, following Resident # 4’s readmission to the facility following his hospital discharge on 2/15/2022, his fingerstick monitoring and sliding scale insulin orders provided for notification upon a blood sugar level of less than 70 mg/dl or greater than 400 mg/dl.”  P. Ex. 7 at 3.

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Even Ms. Elkins wavers in her opinion as to when physician notification was required under applicable standards of care.  In her declaration, she stated that, in her professional opinion, “the readings at face value at that moment in time could be interpreted as maybe not requiring physician/practitioner notification at that very moment.”  CMS Ex. 14 at 6.  Finally, in CMS’s Response brief (CMS RBr.), it “admits that it is unclear from the notes as to when MD# 1 would have expected a provider to be notified of elevated blood sugar readings for R # 4.”  CMS RBr. at 5.  Thus, the allegation that the facility’s failure to notify a physician when blood glucose readings of 210 and 200 were obtained was inconsistent with applicable standards of care for R4 is not supported by the record.

CMS’s final argument as to why Petitioner was not in compliance with 42 C.F.R. § 483.25 was that, even if the blood glucose readings were not at a level requiring physician/practitioner notification, the history of diabetic ketoacidosis necessitates “more frequent monitoring of blood glucose.”  CMS PO Br. at 22 (citing P. Ex. 6 at 16).  CMS further argues that:

as Ms. Elkins-Pogarian explained, given the resident’s history of DKA, the facility should have undertaken some action at the time of the high blood sugar readings.  According to Ms. Elkins Pogarian:  “A blood sugar of 200 mg/dl in a patient/resident known to have unstable blood sugars during a recent hospitalization requiring a diabetic team to review, would be indicative of, at a minimum, rechecking that patient’s/resident’s blood sugar (glucose) within an hour or so to ensure the . . . blood sugar was lowering.  If not, a practitioner should be notified as a dose of insulin may be required especially before the resident eats again.”

CMS PO Br. at 23.

Ms. Elkins does not specifically allege that this practice was a standard of care for a patient with a medical history of DKA and instead indicates it was based on her “professional opinion.”  CMS Ex. 14 at 6.  CMS argues that “the facility’s failure to ensure action when elevated blood glucose readings were recorded is further indicative of a failure to follow applicable standards of practice for patients with a history of DKA,” citing CMS Ex. 14 and P. Ex. 6 at 16.  Petitioner Exhibit 6 at 16, entitled Standards of Medical Care in Diabetes-2013, does, in fact state that any condition leading to deterioration in glycemic controls necessitates more frequent monitoring of blood glucose.  It is doubtful that there would be any dispute about that statement.  However, it does not provide any specific guidance as to recommended frequency of the monitoring or what actions would be appropriate if certain levels of blood glucose were obtained.  Therefore, I do not see this document as identifying specific standards of care that the facility allegedly failed to follow.

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Moreover, Dr. Lazarides included as a diagnosis in the Physician Order Report dated February 6, 2022 “Diabetes mellitus due to underlying condition with ketoacidosis without coma.”  CMS Ex. 8 at 35.  With the knowledge of that diagnosis, they entered orders for a check of R4’s blood glucose twice a day at 9 AM and 9 PM.  Id.  The record establishes that this, in fact, was done as ordered:

02/06/2022 9:15 PM  150 mg/dL
02/07/2022 9:33 AM  142 mg/dL
02/07/2022 9:20 PM   210 mg/dL
02/08/2022 9:35 AM  200 mg/dL

CMS Ex. 8 at 117.

There were no orders on admission to re-check blood sugars if they were found to be at a certain level.  In her testimony, Ms. West stated that in the face of blood glucose readings of 210 and 200, she would not re-check unless there was an order to do so.  Tr. at 16.  Moreover, Dr. Hallett stated that “[a]t 9:35AM on 2/8/2022, Resident # 4 had a blood sugar level of 200 mg/dl, and the prior day at 9:10PM, a reading of 210mg/dl, indicating that in the morning hours of 2/8/2022, his blood sugars were stable.”  P. Ex. 7 at 3.  Thus, there is no apparent reason why a re-check of blood sugars would be a professional standard of practice under the facts of this case.

As detailed above, Petitioner’s evidence, including the statement of both R4’s treating provider, the testimony and written statement of Ms. West, as well as that of William Hallett, a Doctor of Pharmacy and Board Certified Geriatric Pharmacist, establishes by a preponderance of the evidence that the care provided to R4 did not violate applicable professional standards of practice.  See Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007) (“A facility can overcome CMS’s prima facie case either by rebutting the evidence upon which that case rests, or by proving facts that affirmatively show substantial compliance.”) (citing Tri-County Extended Care Center, DAB No. 1936 (2004)).

2. The facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)‑(2).

42 C.F.R. § 483.25 provides that quality of care is a fundamental principle that applies to all care and services provided to facility residents.  The facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices.  Under the provisions of 42 C.F.R. § 483.25(d), the facility must ensure that—

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

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

The Board long ago resolved that “accidents” are events that can cause injury to residents and can be prevented by supervision.  Accidents thus include behavior by a resident that can cause harm to that person.  The regulation’s emphasis is on ensuring that supervision is adequate to meet the specified goal – preventing accidents and keeping residents safe.  Woodstock Care Ctr., DAB No. 1726 at 21, 36 (2000).  Appellate panels of the Departmental Appeals Board (DAB) have held that the regulations require that a facility address foreseeable risks of harm from accidents “by identifying and removing hazards, where possible, or where the hazard is unavoidable because of other resident needs, managing the hazard by reducing the risk of accident to the extent possible.”  Meadowwood Nursing Ctr., DAB No. 2541 at 2 (2013).

Subsection 483.25(d)(2) requires that a facility take “all reasonable steps to ensure that a resident receives supervision and assistance devices that meet his or her assessed needs and mitigate foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115 at 11 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003) (facility must take “all reasonable precautions against residents’ accidents”)).  Facilities are given “the flexibility to choose the methods” they use to provide supervision or assistive devices to prevent accidents, so long as the chosen methods “constitute an ‘adequate’ level of supervision under all circumstances.”  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).

A facility’s obligations under section 483.25 also include furnishing the care and services set forth in its own resident care policies.  Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012) (citing cases), aff’d, 535 F. App’x 468 (6th Cir 2013); Life Care Ctr. of Tullahoma, DAB No. 2304 at 34 (2010) (the care and services required by section 483.25 include care and services called for by a facility’s resident care policy), aff’d, Life Care Ctr. Tullahoma v. Sec’y of United States Dept. of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011); Good Shepherd Home for the Aged, Inc., DAB No. 2858 at 12 (2018) (section 483.25 obligates a SNF to follow its own resident care policies).  Indeed, “[o]nce a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents . . . the facility is held to follow through on them.”  Heritage Plaza, DAB No. 2829 at 20 (2017); Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB No. 3036 (2021).

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CMS asserts that “Petitioner failed to implement interventions consistent with its own policies for three residents with histories of substance use disorder, including when these residents were in possession of and/or known to have taken illicit substances.”  CMS PH Br. at 17.  It further alleged that “the facility did not adhere to its own policies for safeguarding residents from obtaining or using contraband.”  CMS PO Br. at 16.  Petitioner alleged in response that it implemented numerous interventions to protect and supervise residents with substance abuse disorders.  P. PH Br. at 16.  It cited measures that included on-site alcohol and drug counseling, on-site security officers 24 hours a day, and restrictions on leaving the facility.  P. PH Br. at 16-18.  It further asserted that it “implemented numerous, multi-layered interventions to ensure the safety of the residents and regularly evaluated those measures and implemented additional measures when necessary as required by the regulation and CMS’ allegations with respect to these residents is based on inaccurate facts and an incorrect interpretation as to the Petitioner’s obligations under 42 C.F.R. § 483.25(d).”  P. PO Br. at 11-12.

Petitioner did have a number of facility policies related to resident safety.

• Leave of Absence (L OA) Policy

Under this policy, residents may be given a therapeutic leave of absence, after medical clearance from a physician.  Residents with IV access were not eligible for an independent LOA.  Residents with an LOA who were also smokers could obtain cigarettes from the nursing supervisor.  Lighting materials were kept at the front desk and must be returned to the front desk upon return to the facility from LOA.  If it was determined that continued LOAs pose a safety risk to the resident or other residents, the facility could limit or revoke the resident’s right to an LOA.  CMS Ex. 4 at 20.

• Accident and Incidents – Investigating Reporting Policy Statement

This policy indicated that all accidents or incidents involving residents or employees, among others, occurring on the premises shall be investigated and reported to the Administrator.  Incident/Accident reports relating to accident or safety hazards were to be reviewed by the Safety Committee.  CMS Ex. 4 at 2.

• Resident Belongings/Room Search Policy and Procedure

This policy required a reasonable suspicion that a resident had contraband prior to conducting a search.  Contraband was defined in this policy as “[a]ny item that is banned from the facility and/or is of harm to the resident or others.  Items included but are not limited to: guns, knives, ammunition, chemical substances, alcohol, illegal drugs or drug paraphernalia, lighters, and other items that pose safety or risk as determined by staff.”  CMS Ex. 4 at 14.  Under this policy, the provider should be notified of any significant

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findings, at which point the provider would evaluate the resident and make any necessary changes to the plan of care up to and including the revocation of an LOA.  Id.

• Contraband Violations Policy

This facility policy provided that if a resident was found to be in possession of any substances indicated as contraband per the Contraband Admissions Agreement, the facility reserved the right to perform room and/or person searches and an Accident and Incident report would be completed for each contraband violation.  The Contraband Agreement contained examples of contraband violations, which included use or possession of a controlled substance or illegal drug, alcohol, firearm, knife, or other weapon, cigarettes, cigars, pipes, e-cigarettes, vapes or other fire sources, or prescription drugs prescribed outside of the facility.  CMS Ex. 4 at 16.

• Smoking

Under the smoking policy, facility staff will maintain all smoking materials.  If a resident has an order for an independent leave of absence, cigarettes were to be obtained from security at the front desk, and lighting materials were kept at the front desk and were to be returned to the front desk.  In the event the smoking policy was violated, a non-invasive room and person search and counseling would be completed.  After a violation, a smoking assessment was to be completed by the charge nurse.  CMS Ex. 4 at 48.

A review of the record establishes that, despite these policies, the facility failed to ensure that the resident environment remained as free of accident hazards as is possible and that each resident received adequate supervision and assistance devices to prevent accidents.

Three such failures follow.

Resident # 1 (R1)

R1 was admitted to the facility on November 17, 2021 with diagnoses that included a chronic ulcer of the ankle, anxiety disorder, depressive disorder, insomnia, pain, and opioid use.  CMS Ex. 5 at 1-2.  Physician’s orders on admission included Methadone, which could be self-administered.  Id. at 5.  The treating physician also indicated R1 could have an independent Leave of Absence (LOA).  Id. at 8.  Upon admission, R1 signed a facility form entitled “Policy and Procedures:  Leave of Absence.”  Id. at 172.  R1 also signed the Agreement Regarding Contraband Violations.  Id. at 173-174.

In a Resident Progress Note dated December 14, 2021, it was reported that a drug test of R1 was positive for Fentanyl, an unprescribed drug, on December 2, 2021.  CMS Ex. 5 at 144, 199.  Use of a controlled substance or an illegal drug was included as a contraband violation in the facility policy on Contraband Violations in effect at that time.  CMS Ex. 4

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at 16.  However, there was no indication in the record that the facility instituted any of the facility policy provisions for contraband violations, including completing an “Accident & Incident” Report and conducting room searches after every LOA for 90 days.  Id. at 17.  Instead, R1 was merely “educated” on the risks of opioid therapy and overdose.  CMS Ex. 5 at 145.

According to an interview with the Director of Nursing (DON) by the surveyor on March 21, 2022, the facility was told by other residents that R1 may be doing drugs.7  CMS Ex. 9 at 5.  On March 2, 2022, R1’s room was searched on the basis of “Reasonable suspicion.”  CMS Ex. 5 at 180.  According to the Resident Room Search Worksheet, a used needle and razor blades were found in the closet and drug paraphernalia was found in clothing.  Id.  In her interview with the surveyor, the DON stated that during the search, needles, razor blades, metal balls/pipe filters, a pipe with black soot, 2 lighters, and 2 methadone bottles with a trace of green liquid with R1’s name on them were found in the room.  CMS Ex. 9 at 5; CMS Ex. 1 at 45.  According to the form, R1 stated that someone borrowed his coat and he didn’t know where the items came from.  CMS Ex. 5 at 180.

The facility’s definition of contraband, which was contained in the room search policy, defined it as “[a]ny item that is banned from the facility and/or is of harm to the resident or others.  Items included but are not limited to: guns, knives, ammunition, chemical substances, alcohol, illegal drugs or drug paraphernalia, lighters, and other items that pose safety or risk as determined by staff.”  CMS Ex. 4 at 14.  Under this definition, the needles, razor blades, pipe filters, pipe, and lighters would clearly fall within the definition of contraband.8  The question here is whether the facility provided “adequate supervision” to R1 to prevent accidents and responded to the discovery of this concerning contraband in a manner consistent with Medicare guidelines and its own internal policies.

In response to the room search and the resulting discovery of contraband, the facility did conduct follow-up searches of R1’s room on March 9, 2022 and March 17, 2022.  CMS Ex. 5 at 181-82.  However, the facility failed to follow several of its other policies relating to safety.

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• Under the Room Search Policy and Procedure, the provider should be notified of any significant findings, at which point the provider would evaluate the resident and make any necessary changes to the plan of care up to and including the revocation of an LOA.  CMS Ex. 4 at 14.  There is no evidence that the provider was notified of the items found in R1’s room during the room search or that the referenced re-evaluation was done.9
• The facility had a policy for Contraband Violation, which indicated that an Accident and Incident report would be completed for each contraband violation.  CMS Ex. 4 at 17.  Moreover, the Accident and Incidents – Investigating Reporting Policy required that all accidents or incidents involving residents occurring on the premises should be investigated and reported to the Administrator.  Incident/Accident reports relating to accident or safety hazards were to be reviewed by the Safety Committee.  CMS Ex. 4 at 2.  There is no evidence that the facility completed this report after finding contraband in R1’s room during the search on March 2, 2022.
• The facility’s Leave of Absence policy indicated that, if at any time, it was determined that continued LOAs posed a safety risk to the resident or other residents, the facility may limit or revoke the resident’s right to an LOA.  CMS Ex. 4 at 19-20.  There is no evidence that the facility assessed whether continued LOAs by R1 posed a safety risk to him or other residents, despite the finding of used needles, razor blades, and other drug paraphernalia in R1’s room.
• Under the smoking policy, lighting materials were kept at the front desk and were to be returned to the front desk.  If the smoking policy was violated, a smoking assessment was to be completed by the charge nurse.  CMS Ex. 4 at 48.  Even though two lighters were found in R1’s room, a clear violation of the smoking policy, there was no evidence that a smoking assessment was done by the charge nurse.

Petitioner asserts that it did investigate the source of the drug paraphernalia “by questioning Resident # 1” and then accepting his response that he did not know where the items came from and that “someone” had borrowed his coat.  P. PO Br. at 17-18.  It is difficult to accept that a reasonable facility would cease the investigation at that point, assuming R1’s response was even somewhat plausible.  Given the presence of needles,

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razorblades, and lighters, a reasonable facility would follow up with an inquiry as to who borrowed the coat.  A reasonable facility would have also continued to investigate how those items got into R1’s room, if, in fact, R1 did not bring them in.  To imply that simply questioning R1 was a sufficient investigation of the findings from March 2, 2022, particularly when his responses provided no information as to how these dangerous items got into the facility, cannot be seen as ensuring that the resident environment remained as free of accident hazards as possible or that each resident was receiving adequate supervision to prevent accidents.

Petitioner argued that it took “reasonable and appropriate measures to ensure the safety of Resident # 1 and other residents by searching for and confiscating any potential contraband and conducting ongoing room searches, educating Resident # 1 on the risks of overdose and providing psychosocial report.”  P. PO Br. at 19.  The issue here is not whether the facility took some steps to mitigate an assessed risk.  Rather, the issue is whether the facility took all reasonable steps to mitigate an assessed risk.  See Briarwood Nursing Ctr., DAB No. 2115 at 5.  The evidence establishes that the facility failed to “ensure” that each resident’s environment remained as free of accident hazards as possible and that each resident received adequate supervision and assistive devices to prevent accidents.  42 C.F.R. § 483.25(d).  It failed to follow several of its own safety policies when it did not notify the provider of the items found in R1’s room during the room search, complete an Accident and Incidents report after finding contraband in R1’s room, assess whether continued LOAs by R1 posed a safety risk to him or other residents, or conduct a smoking assessment after finding lighters in R1’s room.  See Logan, DAB No. 3036 at 14 (“A facility’s obligations under section 483.25 also includes furnishing the care and services set forth in its own resident care policies.”) (internal citations omitted).  Furthermore, the search of R1’s room revealed several very dangerous contraband items, including used needles, razor blades, a used pipe, and two lighters.  CMS Ex. 1 at 45.  Even though R1 denied having anything to do with these items, the facility was put on notice that someone was bringing these contraband items into the facility, creating an unsafe environment for R1 and all other residents.  There was no investigation as to how needles and razor blades could have been brought into the facility, or obtained in the facility, for that matter.  The failure to act put R1 and the other residents at significant foreseeable risk of harm from accidents due to the dangerous nature of the contraband.  See Meadowwood, DAB No. 2541 at 2.10  In addition to the duty to ensure that R1’s environment was free of accident hazards, the facility also has a duty to protect other residents from the danger posed by this contraband.  Century Care of Crystal Coast, DAB No. 2076 at 18 (2007), aff’d, Century Care of the Crystal Coast v. Leavitt, 281 F. App’x 180 (4th Cir. 2008).  As a result, I must find that the facility failed

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to ensure that the resident environment remained free of accident hazards as is possible and that R1 did not receive adequate supervision to prevent accidents.

Resident # 3 (R3)

R3 was admitted to the facility on October 13, 2020 with diagnoses that included alcohol abuse, hepatic failure, endocarditis, and alcohol hepatitis.  CMS Ex. 6 at 1-2.  On January 31, 2022, a physician issued an order authorizing R3 to have an LOA.  Id. at 41.  In a Resident Progress note dated February 12, 2022 at 11:25 PM, an LPN indicated that when she arrived at R3’s room, after being notified by a nurse that he was on the unit and she should come and get him, the LPN observed that R3 was unresponsive and 911 was called.  A second Resident Progress note dated February 13, 2022 at 12:09 AM indicated the resident was observed to be supine on the floor and unresponsive.  Staff called 911 and EMS took over.  Id. at 69, 87.

According to the EMR report, R3 required one dose of nasal Narcan and two doses of IV Narcan while being transported to the hospital.  R3 reported he drank one pint of vodka the previous day after not drinking for the past year and a half.  CMS Ex. 6 at 129.  R3 was hospitalized from February 12, 2022 through February 23, 2022, with diagnoses that included septic shock secondary to mitral valve endocarditis due to MRSA, alcohol and opioid use disorder, cirrhosis, and esophageal varices.11  Id. at 128.  Lab work done on February 12, 2022 was positive for fentanyl, which was not a prescribed medication, and ethanol.  Id. at 140.  R3 was discharged back to the facility with orders for IV antibiotics through a PICC line.  Id. at 87.

Upon R3’s return to the facility, his physician cancelled the LOA authorization on February 23, 2022.  CMS Ex. 6 at 41.  However, R3 was determined to be able to safely smoke on an independent LOA on March 4, 2022 and the care plan continued to indicate that he could smoke outside in designated areas under the supervision of family/friends.  Id. at 29, 36.

Petitioner does not dispute that a thorough investigation of the source of the drugs was not conducted after the incident on February 12, 2022 and R3 was not formally removed from the approved LOA, but instead argues this did not constitute immediate jeopardy.

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RH at 10.  While the argument as to immediate jeopardy is addressed below, I note that the failure to investigate the possession/use of contraband is inconsistent with the facility’s policy to investigate “all accident or incidents involving residents . . . occurring on the premises.”  CMS Ex. 4 at 2.  Petitioner asserts that since “[i]t was believed the resident obtained the drugs while on LOA,” the failure to determine the source of the drugs did not result in immediate jeopardy, which I am presuming is an argument that no further investigation was necessary.  P. RH at 10.  However, the presumption that R3 “obtained” the drugs outside the facility does not answer the question of whether R3 brought the drugs or alcohol into the facility and consumed them there, which posed a  reasonably foreseeable risk that possibly endangered other residents, in addition to himself.  See Briarwood, DAB No. 2115 at 11.  Moreover, the failure to investigate, including the failure to search R3’s room after the incident, created the risk of contraband remaining in the facility, again placing other residents at risk.  The facility policy on investigations clearly states “all accident or incidents” occurring on the premises will be investigated.12  Furthermore, R3 was still determined to be able to safely smoke outside with family and friends so the risk of further contraband violations remained.  Based on this evidence, I find that the facility failed to ensure that the resident environment remained as free of accident hazards as is possible and that R3 did not receive adequate supervision to prevent accidents.

Resident # 12 (R12)

R12 was admitted to the facility on December 3, 2021 with diagnoses that included rhabdomyolysis, bipolar disorder, anxiety disorder, endocarditis, depression, and cocaine abuse, following a hospitalization for overdose, with rhabdomyolysis and methicillin sensitive staph with tricuspid valve endocarditis.  CMS Ex. 7 at 1-2, 20-21.  Adetola Adedayo, M.D., authorized an LOA on December 22, 2021.  Id. at 41.

On January 19, 2022, during a psychiatry follow up, the provider indicated that they had been advised that R12 had been going on LOA and using drugs and felt guilty.  A staff nurse reportedly advised the provider that R12 had overdosed and Narcan was administered.13  The provider indicated that R12 was initially evasive when asked about the previous day’s events but subsequently admitted to using fentanyl or heroin while going to the store to buy a pastry and a soda.  CMS Ex. 7 at 80, 124, 127.  When seen in follow up by psychiatry on January 20, 2022, R12 was seen for therapy, stating that “I

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don’t even use heroin, only like, once or twice a week.”  Id. at 128.  R12 then requested continuation of Klonopin.  The provider refused to order that medication, indicating that R12 was at risk of death, given his repeated use of heroin and fentanyl.  The provider noted that he had been found on the floor two days ago and needed Narcan to be revived, which was the second time in two months he had had an overdose.  Id. at 85-87.

Petitioner asserts that there was no failure to investigate the overdose incident because “[t]he source of the drugs was clear from Resident # 12’s statement that he was given drugs by someone outside the facility while on an LOA to the store.”  P. PO Br. at 21 (citing CMS Ex. 7 at 80).  Initially, it is noted that R12 would not appear to be the most reliable source of information for the required investigation.  R12, alternately, denied that he had been hospitalized for an overdose and alleged that his “one time use” was not an issue, CMS Ex. 7 at 126; did not believe that he had a substance abuse issue that warranted treatment, id. at 127; admitted to the use of fentanyl or heroin while on a LOA to the corner store, at which time someone followed him and offered him drugs so he “took a bump,” id. at 80; and then stated that he used heroin “only, like once or twice a week.”  Id. at 128.

Even assuming that R12’s statement could be believed, and disregarding all of the other inconsistent statements, this would not relieve the facility of the requirement in its own Accident and Incident - Investigating Reporting Policy to investigate and report to the Administrator all accidents or incidents involving residents, which would then be reviewed by the Safety Committee.  CMS Ex. 4 at 2.  There is no record of this occurring following the incident involving R12 on or about January 18, 2022.  Moreover, an investigation may have clarified whether or not R12 was, in fact, using heroin “only” once or twice a week, which would put R12 at significant risk for overdoses and other complications.

Based on these factors, I find that the facility failed to ensure that the resident environment remained as free of accident hazards as is possible and that R12 did not receive adequate supervision to prevent accidents.

Petitioner has made general arguments that none of its policies required the facility to investigate how a resident obtained contraband, citing CMS Ex. 4.  P. PO Br. at 22.  It is correct that no facility policy makes that statement.  However, the facility policy covering accidents and incidents does require an investigation and report for all accidents or incidents14 occurring on its premises.  CMS Ex. 4 at 2.  R1, R3, and R12 were all involved in incidents or accidents, as discussed above.  The facility policy details 14

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areas to be addressed in the report, only one of which is the injured person’s account of the accident or incident.  The reports are then to be reviewed by the Safety Committee to consider trends related to accident or safety hazards and to analyze individual resident vulnerabilities.  So, to simply accept a resident’s statement at face value or, as with R3, to merely assume what happened, does not comply with the facility’s own policy.  The failure to comply with this policy places the involved residents and all other residents at risk for further incidents or accidents because Petitioner did not follow policies that it determined to be necessary to ensure that residents receive adequate supervision and assistance devices to prevent accidents.  See Heritage Plaza, DAB No. 2829 at 20 (2017).

Petitioner also asserts that it implemented a number of interventions to ensure its residents with substance use disorder (SUD) received appropriate care, treatment, and supervision.  P. PO Br. at 14.  It notes its partnership with a substance abuse treatment center, support groups, 24-hour security officers, cameras, relocation of vending machines, checking of food deliveries, and procedures for leaving the building.  Id. at 14‑15.  Petitioner cites the testimony of its witness that restricting LOAs was very limited, based on instructions from the Long-Term Care Ombudsman.  Id. at 19; Tr. at 21.  It is clear that CMS guidance establishes that a facility cannot restrict a resident’s right to leave the facility.  CMS Ex. 11 at 31.  However, had the required investigations been done and the source of the contraband violations ascertained, modifications or new interventions could have been implemented, such as those suggested in CMS Ex. 11 at 32.  It is not for the trier of fact to suggest treatment modifications.  Rather, it is the facility’s responsibility to follow its own policies, in conjunction with agency regulations, to ensure resident safety.  Had the facility instigated its required investigation at the time of the initial evidence of contraband, which was R1’s abnormal drug screen on December 2, 2021, it perhaps could have prevented the subsequent incidents described above.

A facility “is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an ‘adequate’ level of supervision under all the circumstances.”  Windsor Health Care Ctr., DAB No. 1902 at 5.  Even assuming that the above residents had the right to take risks with their own safety, the failure to investigate, in compliance with its own policies, and then consider new interventions, posed health and safety risks for those residents and other residents in the facility for whose care it was responsible.  Petitioner’s failure to follow its own policies posed a risk of more than minimal harm to its residents and resulted in harm to R3 and R12; therefore, Petitioner was not in substantial compliance with the participation requirement at 42 C.F.R. § 483.25(d)(1)(2); see 42 C.F.R. § 488.301 (definition of substantial compliance).

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3. CMS’s determination that Petitioner’s noncompliance with 42 C.F.R. § 483.25(d)(1)(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.  CMS’s determination as to the level of a facility’s noncompliance, which would include an immediate jeopardy finding, must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Barbourville Nursing Home, DAB No. 1962 (2005) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

Petitioner asserts that “CMS fails to establish a serious adverse outcome or likely serious outcome resulting from the Petitioner’s alleged noncompliance.  Petitioner assessed the risks, not only to Residents # 1, 3 and 12 but to all SUD residents, and took numerous measures to provide supervision to such residents.”  P. PO Br. at 22-23.  It further argues that “CMS fails to establish even a prima facie case that any alleged noncompliance caused or was likely to cause, serious harm, impairment or death.”  Id. at 12.

The facility’s failure to comply with its own policies lead to “serious harm” to two of the above residents and risk of serious harm to other residents in the facility.  R12 was able to obtain and use unprescribed drugs, resulting in an overdose and requiring the administration of Narcan.  CMS Ex. 7 at 80.  R3 was discovered unresponsive on the floor of his room, after consuming “one pint of vodka” and fentanyl the previous day, again requiring the administration of Narcan.  CMS Ex. 6 at 69, 87.  R1 was discovered to have in his room, in addition to other contraband, used needles, razor blades, lighters, and drug paraphernalia, posing a significant risk to himself and other residents.  CMS Ex. 9 at 5; CMS Ex. 1 at 45.  These consequences are clearly “serious” since the health and safety of facility residents was or could have been endangered.  Based on the above evidence, I find that CMS’s determination that the deficiencies posed immediate jeopardy to resident health and safety was not clearly erroneous.

4. The penalties imposed are reasonable in amount and duration.

Prior to assessing the reasonableness of the CMP in this case, it is necessary to determine the amount of the penalty at issue.  As noted above, CMS initially notified Petitioner that it was imposing a CMP in the amount of $9,800 per day for five days, from March 23, 2022, through March 27, 2022, as a result of the immediate jeopardy noncompliance. CMS Ex. 2 at 1.  CMS also informed Petitioner that it was imposing a CMP in the amount of $360 per day for a period of 38 days, for the period of March 28, 2022,

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through May 4, 2022, based on Petitioner’s continued  noncompliance at a lower scope and severity level.  Id.  In the RH, Petitioner contested the five day $9,800 per day CMP for noncompliance at the immediate jeopardy level but did not address the subsequent CMP of $360 per day for 38 days.  RH at 5.

CMS subsequently revised the CMP to $7,445 per day for the five days from March 23, 2022 through March 27, 2022, for a total of $37,225, based on noncompliance with Tag F684, 42 C.F.R. § 483.25, at a G level, and Tag F689, 42 C.F.R. § 483.25(d)(1), (2), at a J level.  CMS Ex. 2 at 8.  As a result, the total amount of the CMP at issue in this matter is $37,225.15

My conclusion that there was no noncompliance under Tag F684 would generally cause me to adjust the per day CMP downward.  However, no such adjustment is possible in this case.  Because I sustained the finding of noncompliance with Tag F689 at the immediate jeopardy level, the penalty amount for the first five days of the period of noncompliance must be from the higher range of penalties.  42 C.F.R. § 488.438(a)(1)(i).  For the year in question, that range is $7,317 to $23,989 per day.  45 C.F.R. § 102.3 (2022); 87 Fed. Reg. at 15,100, 15,112 (March 17, 2022).  I have not reduced the $7,445 per-day CMP for the period of immediate jeopardy noncompliance because that amount is near the bottom of the CMP higher range already and I cannot consider amounts in the lower range.

In assessing the reasonableness of any penalties imposed, consideration is given to the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  See 42 U.S.C. §§ 1320a-7a(d)(2), 1395i-3(h)(2)(B)(ii)(I).  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in 42 C.F.R. § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  See 42 U.S.C. §§ 1320a-7a(d)(1), (3), 1395i-3(h)(2)(B)(ii)(I).

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 §§ 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.

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§ 488.438(e)(2) and (3); Alexandria Place, DAB No. 2245 at 27 (2009); Kenton Healthcare, LLC, DAB No. 2186 at 28-29 (2008).  However, 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 (2002).

In this case, Petitioner makes no argument regarding the reasonableness of the CMP or the application of the regulatory factors, other than to assert that “the amount of the CMP should also be reduced to reflect noncompliance which did not result in immediate jeopardy.”  P. PO Br. at 23, P. PH Br. at 23.  However, as discussed above, the penalty imposed is already at the lowest range of penalties for deficiencies constituting immediate jeopardy and, absent any contention from Petitioner regarding the regulatory factors for reasonableness, I find the penalty imposed by CMS of $7,445 per day for the five days from March 23, 2022, through March 27, 2022 for a total of $37,225 to be reasonable.

IV.    Conclusion

I find that the facility was in substantial compliance with 42 C.F.R. § 483.25 but was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)(2); the determination of immediate jeopardy was not clearly erroneous; and the CMP imposed of $7,445 per day for the five days from March 23, 2022, through March 27, 2022, for a total of $37,225, is reasonable.