Westside Care Center, LLC, DAB CR6598 (2025)

DECISION

In this case, I consider a skilled nursing facility’s obligation to protect, from injury or death caused by illicit substance abuse, its residents suffering from substance use disorder.

Petitioner, Westside Care Center LLC, is a skilled nursing facility, located in Manchester, Connecticut, that participates in the Medicare program. Its residents include individuals suffering from substance use disorder. Some of those residents obtained, possessed, and ingested Fentanyl and other illicit drugs. They overdosed, and one resident died following an overdose.

Based on a complaint investigation, completed on February 2, 2023, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and imposed civil money penalties (CMPs) of $8,265 per day for 22 days of immediate jeopardy and $245 per day for 34 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner appealed only the immediate jeopardy determination and resulting CMP. CMS has moved for summary judgment, which Petitioner opposes.

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For the reasons set forth below, I grant CMS’s motion. The undisputed evidence establishes that, from January 9 through 30, 2023, the facility was not in substantial compliance with the Medicare program requirement governing quality of care and accident prevention: 42 C.F.R. § 483.25(d)(1) and (2). I find that this deficiency posed immediate jeopardy to resident health and safety and that the penalty imposed is reasonable.

Background

The Social Security Act (Act) sets forth requirements for nursing facilities to participate in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those 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. Act § 1864(a); 42 C.F.R. § 488.20. Each facility must be surveyed annually, with no more than 15 months elapsing between surveys. Facilities must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected. Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308. The state agency must also investigate all complaints. Act § 1819(g)(4).

Here, responding to a report that a facility resident suffered a serious drug overdose, surveyors from the Connecticut Department of Public Health, Facility Licensing and Investigation Section, conducted a complaint investigation from January 9 through February 2, 2023. CMS Ex. 16, CMS Ex. 23 at 2 (Predka Decl. ¶ 6). Based on the investigation findings, CMS determined that the facility was not in substantial compliance with:

• 42 C.F.R. § 483.25(d)(1) and (2) (Tag F689 – quality of care: accident prevention), cited at scope-and-severity level J (isolated instance of substantial noncompliance that poses immediate jeopardy to resident health and safety);
• 42 C.F.R. § 483.12(a)(1) (Tag F600 – freedom from abuse, neglect, and exploitation), cited at scope-and-severity level D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm);

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• 42 C.F.R. § 483.21(a)(1)-(3) (Tag F655 – comprehensive, person-centered care planning: baseline care plan), cited at scope-and-severity level D;
• 42 C.F.R. § 483.25 (Tag F684 – quality of care), cited at scope-and-severity level D; and
• 42 C.F.R. § 483.20(f)(5) (Tag F842 – resident assessment: records), cited at scope-and-severity level D.

CMS Exs. 16, 21, 22.

The surveyors revisited the facility on March 23, 2023. Based on their findings, CMS determined that the facility returned to substantial compliance on March 6, 2023. CMS Ex. 22.

CMS imposed CMPs of $8,265 per day for 22 days of immediate jeopardy (January 9-30, 2023) and $245 per day for 34 days of substantial noncompliance that did not pose immediate jeopardy (January 31 through March 5, 2023) (Total: $181,830 + $8,330 = $190,160). CMS Exs. 21, 22.

Petitioner timely requested review but has limited its appeal to the deficiency cited under section 483.25(d)(1) and (2), the immediate jeopardy determination, and the $8,265 per-day CMP. Request for Hearing at 1.

Exhibits. The parties filed pre-hearing briefs (CMS Br.; P. Br.). Thereafter, CMS filed a Motion for Summary Judgment (CMS MSJ), and Petitioner filed its opposition (P. Opp.).

CMS has submitted 32 exhibits (CMS Exs. 1-32), and Petitioner has (belatedly) submitted two documents: the written declarations of J. Craig Allen (a physician specializing in substance use disorders) and George Kingston (a nursing home administrator not affiliated with Petitioner). Contrary to the instructions in my prehearing order, the documents are not marked as exhibits. I nevertheless refer to Petitioner’s documents as P. Ex. 1 (Allen Decl.) and P. Ex. 2 (Kingston Decl.).

CMS objects to my admitting Petitioner’s documents. For purposes of summary judgment, I need not rule on the objections but will consider the proffered evidence to determine whether it creates a material fact in dispute. Lilia Gorovits, M.D., P.C., DAB No. 2985 at 3 (2020), aff’d, Gorovits v. Becerra, 20-1850 (E.D. Pa. May 17, 2021); Ill. Knights Templar Home, DAB No. 2274 at 6-7 (2009).

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Issues

Because Petitioner does not challenge the deficiencies cited under sections 483.12(a)(1), 483.21(a)(1)-(3), 483.25, and 483.20(f)(5), I find that, from January 31 through March 5, 2023, the facility was not in substantial compliance with Medicare program requirements and that the CMP imposed ($245 per day) is reasonable.

With respect to the issues before me, I consider whether summary judgment is appropriate.

On the merits, the issues are:

• From January 9 through 30, 2023, was the facility in substantial compliance with 42 C.F.R. § 483.25(d)(1) and (2);
• If the facility was not then in substantial compliance with section 483.25(d)(1) and (2), did that deficiency pose immediate jeopardy to resident health and safety; and
• If the facility was not in substantial compliance with section 483.25(d)(1) and (2), is the CMP – $8,265 per day for 22 days of immediate jeopardy – reasonable?

Discussion

Summary judgment. Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law. Southpark Meadows Nursing & Rehab. Center, DAB No. 2703 at 5 (2016); W. Texas LTC Partners, Inc., DAB No. 2652 at 5 (2015), aff’d, W. Tex. LTC Partners, Inc. v. U.S. Dep’t of Health & Human Servs., 843 F.3d 1043 (5th Cir. 2016); Bartley Healthcare Nursing & Rehab., DAB No. 2539 at 3 (2013) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986)); Ill. Knights Templar Home, DAB No. 2274 at 3-4 (and cases cited therein).1 

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The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.” Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs., 388 F.3d 168, 173 (6th Cir. 2004) (quoting Celotex, 477 U.S. at 322). To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986) (emphasis added); see also Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004). The non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact. Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5 (2003). In doing so, the non-moving party must show more than “some metaphysical doubt as to the material facts.” W. Tex. LTC Partners, DAB No. 2652 at 6; 1866ICPayday.com, L.L.C., DAB No. 2289 at 3 (2009) (quoting Matsushita, 475 U.S. at 587).

In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non-moving party. Heritage House of Marshall Health and Rehab., DAB No. 3035 at 8 (2021); Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr., 388 F.3d at 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004). However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions or draw inferences that are not reasonable. Vibra Hospital of Charleston – TCU, DAB No. 3094 at 11 (2023); W. Tex. LTC, DAB No. 2652 at 6-7; cf. Guardian, DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed and there is only one reasonable conclusion that can be drawn from those facts.”); see Green Valley Health Care & Rehab. Ctr., DAB No. 2947 at 8 (2019) (quoting Johnson v. Perez, 823 F. 3d, 701, 705 (D.C. Cir. 2016)) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position”); Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).

Summary judgment applied to administrative review in Medicare cases. It is well-established that an administrative law judge is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing. Shah v. Azar, 920 F.3d 987, 996 (5th Cir. 2019) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010).

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There seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some suggesting that, to do so, denies a party a fundamental right. In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals shattered this misconception: “All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.” Fal-Meridian, 604 F.3d at 449 (emphasis added); see Cedar Lake Nursing Home, 619 F.3d 453, 457-58 (affirming summary judgment that was based on the ALJ’s “specific, undisputed findings of fact,” accepting as true the facts presented by the Petitioner).

As the following discussion shows, no issues in this matter “would benefit from being resolved in an evidentiary hearing.” CMS’s case rests primarily on the facility’s own documents, supplemented with statements that facility staff made to the state surveyor. Petitioner has not questioned the facts set forth in its documents nor presented the testimony of any employees denying that they made the statements or claiming that the statements are untrue. The statements may therefore constitute substantial evidence. Omni Manor Nursing Home, DAB No. 1920 at 11 (2004); see Beatrice State Development Ctr., DAB No. 2311 at 17, 18 (2010) (pointing out that the facility could have, but did not, present testimony that refuted the statements the surveyors claimed they made).

As for Petitioner’s own two witnesses, they are outsiders, who have no direct knowledge of any facts underlying the deficiencies cited by CMS. Only one witness, Greg Kingston, a nursing home administrator who is not affiliated with the facility, claims to know what was going on in the facility. But he offers no specific facts, only a conclusory statement that the facility “has been continuously diligent in attempting to eliminate or reduce the presence of Fentanyl and other illicit drugs.” P. Ex. 2 (Kingston Decl. ¶ 6). Conclusory statements that are unsubstantiated by evidence of specific facts are insufficient to create a genuine factual dispute and do not preclude summary judgment. See Guardian, DAB No. 1943 at 11 (characterizing as “conclusory in nature” claims that the facility provided “effective,” “appropriate,” or “aggressive” interventions).

As I did in Cedar Lake, I base this decision on my “specific, undisputed findings of fact” and accept as true the facts presented by Petitioner.

Summary judgment applied to CMPs. Whether the penalty amount imposed is reasonable is a legal, not a factual, issue. To overcome a summary judgment motion as to the reasonableness of the penalties, the facility must proffer evidence sufficient to create a genuine dispute about facts affecting how the regulatory factors should be assessed. Vibra Hospital of Charleston, DAB No. 3094 at 30 (2023); Crawford Healthcare, DAB No. 2738 at 19 (2016).

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1. CMS is entitled to summary judgment finding that the facility was not in substantial compliance with 42 C.F.R. § 483.25(d)(1) and (2) because the undisputed evidence establishes that facility staff did not follow the directions of a resident’s care plan nor the facility’s policies that were designed to prevent resident access to dangerous drugs and other illicit substances.2 

42 C.F.R. § 483.25(d) (Tag F684). The Medicare 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. To this end, the “quality-of-care” regulation mandates, among other requirements, that each resident’s environment remain as free of accident hazards as possible and that each resident receive adequate supervision and assistive devices to prevent accidents. 42 C.F.R. § 483.25(d); Del Rosa Villa, DAB No. 2458 at 7 (2012); Clermont Nursing & Convalescent Ctr., DAB No. 1923 at 9-10, aff’d sub nom. Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 Fr. App’x. 900 (6th Cir. 2005); accord Briarwood Nursing Ctr., DAB No. 2115 at 5 (2007) (holding that the facility must “take all reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and mitigate foreseeable risks of harm from accidents”).3 

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)). “The regulation focuses not on whether an

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accident occurs, but, rather, on whether the facility has provided supervision and assistance devices adequate to prevent an accident.” Kenton Healthcare, DAB No. 2186 at 13 (2008).

Facility policies

[T]he Board has repeatedly held that the requirements under section 483.25 “obligate the [facility] to furnish the care and services set forth in the resident’s care plan, to implement doctor’s orders, to monitor and document the resident’s condition, and . . . to follow its own resident care policies.” Good Shepherd Home for the Aged, Inc. d/b/a The Good Shepard Home, DAB No. 2858 at 12 (2018) (citing Life Care Ctr. of Bardstown, DAB No. 2479 at 22 (2012)) (citing cases), aff’d 535 F. App’x 468 (6th Cir. 2013); Woodland Village Nursing Ctr., DAB No. 2053 at 9 (citing cases), aff’d, 239 F. App’x 80 (5th Cir. 2007). The . . . ALJ . . . may “rely on a facility policy as evidence of the provider’s own judgment as to what must be done to attain or maintain its residents’ highest practicable physical, mental, and psychosocial well-being, as required by section 483.25.” Senior Rehab., DAB No. 2300 at 13 (quoting Sheridan Health Care Ctr., DAB No. 2178 at 15).

Heritage House, DAB No. 3035 at 10 (emphasis added); accord Green Valley Healthcare and Rehab. Ctr., DAB No. 2947 at 6 (2019) (citing The Laurels at Forest Glen, DAB No. 2182 at 18 (2008)); North Las Vegas Care Ctr., DAB No. 2946 at 6 (2019); Good Shepherd Home for the Aged d/b/a The Good Shepherd Home, DAB No. 2858 at 14 (holding that a facility violates [what is now] section 483.25(d) if it fails, without justifiable reason, to implement the accident precautions its own staff have determined are necessary to mitigate foreseeable accident risks); West Texas LTC Partners, Inc., DAB No. 2652 at 14 (holding that, at a minimum, to comply with section 483.25, the facility must follow its own policies and protocols); Hanover Hills Health Care Ctr., DAB No. 2507 at 6 (2013) (observing that “the Board has long held that a facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality-of-care requirements in section 483.25”).

CMS submits copies of the facility’s policies. CMS Exs. 17-20. Two sets of those policies are accompanied by memos from the facility’s administrator. CMS Exs. 17, 18 (discussed below). Petitioner does not concede that the instructions accompanying the administrator’s first memo (CMS Ex. 17) are “policies” but asserts, “The memo speaks for itself.” P. Opp. at 6-7. Obviously, each of the administrator’s two memos “speaks for itself”; each memo says that, to prevent residents from acquiring illicit drugs, all of these procedures must be followed during visits. You can quibble about the nomenclature, but, plainly, these instructions show the facility’s “own judgment as to what must be done to attain or maintain its residents’ highest practicable physical, mental, and psychosocial

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well-being, as required by section 483.25.” Sheridan Health Care Ctr., DAB No. 2178 at 15.

Witness Kingston, himself a licensed nursing home administrator, agrees that these instructions constitute “best practices” for eliminating the presence of illicit drugs in a facility. P. Ex. 2 (Kingston Decl. ¶ 7). I consider this opinion, together with the facility administrator’s memos (CMS Exs. 17, 18), sufficient to establish what the facility determined was “needed to meet the quality of care requirements in section 483.25.” See Hanover Hills, DAB No. 2507 at 6.

Facility policy: supervised visit process. In a memo dated August 5, 2022, the facility administrator described an episode “this week” of a resident obtaining illicit substances due to having a visitor in the resident room. “Clearly, this is contrary to how supervised visits should be conducted.” With the memo, the administrator sent to staff copies of the facility’s policy for supervised visits. CMS Ex. 17 at 1.

The policy explains that, because the facility provides sub-acute care to residents with a medical condition brought on by substance use disorder, staff are required to “be vigilant in ensuring that drugs and other illicit substances do not enter the building.” CMS Ex. 17 at 2. The policy points to the “two major routes” by which illicit substances enter the building: visitors and deliveries – both through the front door. For that reason, the receptionist and security play a key role in preventing incidents. The policy then lists “the procedure that must be followed during visits” (emphasis in original):

• Residents who require supervised visits have their names shaded on the resident roster.
• Supervised visits occur in either the conference room or the room behind the receptionist area.
• There are no exceptions unless specifically approved by the Administrator or Director of Nursing on an individual visit basis.
• The visitor will remain in the outer lobby until the resident comes to the front area for the visit.
• Once the resident is in the visit location (Conference Room or Aging Room), the visitor will be escorted into the visit room.
• Security remains in the room for the entire visit, no exceptions.
• There will be no physical contact between visitor and resident.

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• There will be no passing of food or other substances during the visit.
• At no time will the visitor and the resident be left alone.

CMS Ex. 17 at 2.

Facility policy: supervised visit process. An amended version of the supervised visit policy (also attached to the August 5 memo) includes all the procedures listed in the earlier version (CMS Ex. 17 at 2) and adds:

• If a visitor requests to use the bathroom, the bathroom next to the Administrator’s office will be the ONLY bathroom used. No exceptions

CMS Ex. 17 at 7 (emphasis added).

Facility policy: package inspection. The facility’s policy for package inspection lists the “procedure that must be followed during visits” (emphasis in original):

• Residents on supervised visits are required to have packages examined. This includes food deliveries, laundry, packages in the mail and store deliveries.
• Proper searches take time. “It is best” to tell the person delivering the items that they will be delivered to the resident shortly.
• When searching laundry, carefully check all pockets and place the clothing inside out to verify that nothing is attached to the seams. When finished, fold the laundry as it was given to you.
• When inspecting groceries, only sealed containers will be accepted. Open containers will be returned. If a multiple pack of soda is delivered, open the pack and make sure nothing is between the cans.
• If a bag of chips or other snack is delivered, make certain that the bag appears to have air in it and looks normal. People will open a bag along the seam and place drugs inside and glue the bag closed.
• Make certain sealed containers haven’t been previously opened. Check for glued back corners.

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• If uncertain of any item, it’s best to secure it. Someone else can check it the next day. All items not delivered to the resident must be secured in the room with the cigarettes.
• Package deliveries from Amazon or the mail should be opened with the resident present. “Activities” can perform this function.
• Prepared food items can be delivered only from pre-selected restaurants. The list is at the front desk. Food-delivery groups like Door-Dash should not be accepted. When food is delivered, examine it with a disposable knife of fork to ensure that no illicit substances are included.
• Once all items have been checked carefully, deliver to the resident.

CMS Ex. 17 at 3-4.

Facility policy: package inspection. An updated policy for package inspection lists the same procedures as the first policy (CMS Ex. 17 at 3-4) and adds:

• Ask the resident for permission to search the bag. Tell the resident that we need to make sure your belongings do not contain any unsafe items. We request to examine your bags/suitcases/belongings so that we can make sure all the contents are safe.
• If the resident declines the above, verify that the risk assessment has determined that [due] to resident safety the bags should be searched. A shaded roster indicates a positive risk assessment.

CMS Ex. 17 at 8.

Facility policy: hazardous or precautionary items. A separate set of policies addresses the problem of hazardous items. This includes a policy intended to “ensure [a] safe and healthy environment for all residents” and lists items considered “hazardous or precautionary.” The listed items are deemed potentially dangerous or may pose significant health risks and must be handled on facility premises by or under the supervision and/or discretion of staff. CMS Ex. 20 at 2.

On admission, staff must review with all competent residents, or the responsible parties of incompetent residents, a list of hazardous or precautionary items. These items include: sharp items; intoxicating substances, including liquor, beer, wine; illegal drugs; weapons; smoking materials, such as tobacco, cigarettes, cigars, pipes; lighters/matches; independent lighting/ignition materials, including candles, incense; medications, unless

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approved by the interdisciplinary team; and other items deemed unsafe or inappropriate by the interdisciplinary team. Id.

If staff suspect hazardous or precautionary items, they immediately notify the supervisor. The facility will then decide whether to use the facility-approved “room-search” and/or “belongings search” procedures and protocols. Id.

If staff detect hazardous or precautionary items, and the item presents a risk to the safety and health of others, staff will immediately facilitate the isolation or removal of the risk and inform the supervisor. If illegal drugs or weapons are suspected or detected, the facility will contact local law enforcement for assistance. CMS Ex. 20 at 3.

Staff should not conduct searches of a resident or personal belongings unless the resident or resident’s representative agrees to a voluntary search and understands the reason for the search. Exceptions can be made when staff suspect and document an imminent risk to the safety of any resident or staff. Id.

Facility policy: room searches. The facility had in place a room-search policy, aimed at ensuring “the safety of the treatment and residential environment and those that reside, work, and visit there.” CMS Ex. 20 at 32. Among other provisions, the policy directs staff to “strive to ensure” that the resident environment remains as free from accident hazards as possible. If staff have reasonable cause to suspect hazardous or precautionary items within the treatment and residential areas of the facility, they may institute room searches and remove or isolate from resident use any hazardous or precautionary items or materials. If there is suspected and documented imminent risk to resident or staff safety, staff may search without resident approval. Id.

The policy lists procedures for room searches and provides that, upon discovery of any objects considered illegal, staff will contact law enforcement. They will record room searches in the facility records, using the room search worksheet or similar document. CMS Ex. 20 at 33.

Facility policy: new admissions. The facility’s policy for new admissions lists the procedure that must be followed when a new resident arrives:

• The facility is notified that a new resident is being admitted. Included in the information provided is whether the resident requires supervised visits, and this information is given to the reception desk. Place the resident’s name in the appropriate bed on the resident roster and write next to the name: “Supervised Visit.” This is a reminder until the resident roster is updated. Once updated, the resident name is shaded, indicating supervised visits and package inspections.

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• When the resident arrives to be admitted and meets the requirements for supervised visits, the policy directs staff to ask the ambulance or chair car attendant for the resident’s personal belongings, explaining that they will be delivered to the resident once the resident is in the resident’s room. If the resident doesn’t allow staff to collect the bags, the resident stays in the lobby and the person who is “running the building” at the time speaks to the resident.
• Once the personal belongings are collected, they should be searched to ensure that no illicit items are inside. Carefully check wallets and purses and all the little pockets. Check all items in the personal bags. Once completed, return the bags to the resident on the unit. If unsure about an item, secure it in the cigarette room, and someone will verify the next day.

CMS Ex. 17 at 5.

Facility policy: new admissions. The facility updated the policy for new admissions by adding some minor edits (as highlighted below in italics):

• The facility is notified that a new resident is being admitted. Included in the information provided is whether the resident requires supervised visits, and this information is given to the reception desk. Place the resident’s name in the appropriate bed on the resident roster and write next to the name: “Supervised Visit” and/or “Package/Bag Search.” This is a reminder until the resident roster is updated. Once updated the resident name is shaded, indicating supervised visits and package inspections.
• When the resident arrives to be admitted and meets the requirements for supervised visits, ask the ambulance or chair car attendant for the resident’s personal belongings. Have the resident sign the Belongings Search Form (Attached). Explain that they will be delivered to the resident once the resident is in the resident’s room. If the resident doesn’t allow you to collect the bags, have the resident stay in the lobby and ask the person who is “running the building” at the time to come down and speak to the resident. Complete the form as indicated for items 1 and 2.

CMS Ex. 17 at 10.

Facility policy: fresh air breaks. The facility’s policy for fresh air breaks lists the procedure that must be followed during fresh air breaks:

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• Security must be present during fresh air breaks.
• Security has primary responsibility for ensuring that no arriving visitors go directly to a resident who is on supervised visits.
• If a visitor approaches, ask the visitor to go into the lobby to check in and tell the visitor that the resident will be in shortly.
• Once the resident has re-entered the facility, follow the normal supervised visit protocol.

CMS Ex. 17 at 6, 11.

Policy/Procedure Update. In a second memo, dated September 27, 2022, the facility administrator again reported an episode “this week” in which a resident came into contact with an illicit substance. The substance entered through the front door. The administrator again stressed that the front door is “the first line of defense” in preventing illicit substances from entering the building. He reminded staff that the “carefully outlined procedures” must be followed. Food deliveries can be accepted only from one of four existing food establishments.

The update added two additional procedures:

• Effective immediately, all food and package deliveries must be maintained in the accompanying log (which is attached). All packages of highlighted residents must be inspected.
• Effective September 30, 2022, all food delivery orders will be called in by the receptionist. If the order is not for one of the approved vendors, the phone order should not be completed.

CMS Ex. 18 (emphasis added).

Facility policy: standing orders for Naloxone. The facility had in place standing orders for Naloxone, an opioid antagonist, used to reverse the effects of opioids. The drug is administered to prevent death and reduce disability and injury from opioid overdoses. Under the policy, when permitted by state law/regulation and facility policy, a registered nurse may administer Naloxone to a resident experiencing respiratory depression, unresponsiveness, or respiratory or cardiac arrest, and an opioid overdose is suspected. CMS Ex. 20 at 1.

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The policy outlines the procedures the nurse must follow in administering the medication. The encounter must be documented in the resident’s medical record. Documentation must include the resident presentation, route (internasal or IM), dose administered, and the resident’s response. Id.

Facility policy: care plan. Consistent with the regulations, the facility policy dictates that each resident have a comprehensive, person-centered plan of care. CMS Ex. 20 at 4; see 42 C.F.R. § 483.21. The policy reflects regulatory requirements for care-planning, including developing a baseline care plan followed by “comprehensive care plan development.” CMS Ex. 20 at 5-6.

Facility policy: nursing progress notes. The facility policy mandates that the resident’s progress “be documented in the medical record by licensed staff, as required.” CMS Ex. 20 at 7. Specifically, nursing staff are directed to use the “Nurses’ Progress Notes” form. Documentation must be in black ink. Each entry must identify the date and time of the occurrence. Id.

Facility policy: scope of social work services. The facility policy requires that professional social work services be provided in order to attain or maintain the resident’s highest practicable physical, mental, and psychosocial well-being. CMS Ex. 20 at 23. Among other responsibilities, social work practices include identifying and planning a response to the resident’s known psychosocial needs, including the resident’s abuse of alcohol or other drugs. Id.

Facility policy: social work documentation. As with nurses’ notes, the facility’s policy for social work documentation requires that entries be in ink and be dated and signed at the time of entry.

A short-term rehab social work case evaluation must be completed within 72 hours of the resident’s admission and maintained in the resident’s clinical record. If the resident’s anticipated stay becomes long term, an initial social work assessment must be done. The assessments are maintained in the resident’s clinical record and identify known psychosocial conditions that may potentially affect the resident’s care and well-being.

Periodic and interim recording of service, staff observations, and assessments are entered into the social service section of the medical record. Quarterly social service progress documentation must be entered into the clinical record prior to the scheduled resident care conference. The contents must comply with applicable standards and regulations. CMS Ex. 20 at 9, 35-37. Among its specific provisions, the policy provides that post-incident notes be entered either in a narrative progress note or on the “Interim Occurrence Response” form. CMS Ex. 20 at 36.

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The policy includes specific documentation requirements for the various categories of social work assessment (initial, person-centered, short-term rehab, post-MDS review, quarterly progress, interim, discharge planning). CMS Ex. 20 at 9-11.

The policy also requires that assessments of risk of harm to self or others be entered in the resident’s clinical record. All checks must be documented in the clinical record. Staff monitoring of residents should be entered on either Q15 or Q30 minutes flowsheet. One-on-one monitoring should be entered on a Q15 minute flowsheet. CMS Ex. 20 at 12.

Facility policy: reportable events – reporting allegations and incidents. According to the facility’s policy, it would report all allegations and incidents, as required by state and federal law. CMS Ex. 20 at 13. The policy defines “reportable event” as an event “that is clinically unusual or inconsistent with the policies and practice of the facility.” Id. The policy also provides specific procedures for reporting and investigating these events. CMS Ex. 20 at 13-17.

Facility policy: close observation. A facility policy provides staff with guidance “in applying close observation levels” in order to ensure resident safety. The policy explains that “close observation” consists of “multiple levels of resident observation options that offer staff the choice of a close observational response that is proportional to the level of risk to resident safety or wellbeing.” CMS Ex. 20 at 18.

The policy lists risk factors, including for new admissions, “decompensated mental status,” and others. Id. The policy lists the various close-observation levels. CMS Ex. 20 at 19-20.

Resident 5 (R5). R5 was a 29-year-old man, admitted to the facility on August 5, 2022, following hip surgery. CMS Ex. 1 at 1; CMS Ex. 4 at 9; CMS Ex. 6 at 3, 7. In addition to his post-surgery status, his diagnoses included oppositional defiant disorder, attention-deficit hyperactivity disorder, and an adjustment disorder with mixed anxiety and depressed mood. CMS Ex. 1 at 2; CMS Ex. 4 at 9; CMS Ex. 6 at 9. He was separately diagnosed with an intellectual disability. CMS Ex. 7 at 3; see CMS Ex. 4 at 9. A social services note, dated August 22, 2022, indicates that R5 is cognitively intact, with a BIMS (Brief Interview for Mental Status) score of 15/15. CMS Ex. 4 at 3.

From early on, R5 showed a willingness to disregard facility rules. In a note dated August 22, 2024, the social worker records that she spoke to him about his unauthorized smoking over the previous weekend. He admitted that he and two other residents went outside to smoke, without supervision. Id. The facility did not consider amending his care plan or increasing his level of supervision.

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R5 had a history of substance abuse, including abusing opioids. CMS Ex. 2 at 3, 18; CMS Ex. 3 at 16. When he was admitted to the hospital for his hip surgery (on July 28, 2022), he had Fentanyl and cocaine in his system. CMS Ex. 6 at 36; CMS Ex. 16 at 17‑18.

Inaccurate assessment. At the time of his admission, facility staff filled out a “Visitor Risk Assessment.” According to that document, R5 had not used illicit substances within 30 days prior to his admission. CMS Ex. 1 at 7. Inasmuch as R5 tested positive for Fentanyl and cocaine on July 28, 2022 – just one week earlier – it seems that he had used these substances within the 30 days prior to August 5, 2022. CMS Ex. 6 at 36. Nevertheless, based on this misinformation, the document concludes that R5 may have visitors without restrictions. CMS Ex. 1 at 7. Thus, because staff were not aware that R5 had used drugs during the 30 days prior to his admission, they did not then implement supervised visits. This was the first of several mistakes the facility made in its treatment of R5. CMS Ex. 9 at 1; CMS Ex. 23 at 2 (Predka Decl. ¶ 10e).

The facility’s vice president of business development, who oversees the admissions team, acknowledged the error. He told Surveyor Aneta Predka that the facility’s “admission liaison” did not electronically send R5’s preadmission evaluation, which was an “omission.” CMS Ex. 9 at 21. Petitioner acknowledges that the facility “was late to recognize [R5’s] drug use” but suggests that, because it placed the resident on close supervision no later than September 11, 2022, and added substance use disorder to the care plan “soon thereafter,” the error was of no consequence. P. Opp. at 16.

I disagree. Because of this error, a resident with a significant history of substance use disorder was not adequately supervised for at least five weeks following his admission. His care plan was not amended to reflect the required level of supervision until more than two weeks later (on September 27, after he was caught with illicit drugs). Thus, almost eight weeks elapsed before his plan accurately reflected his need for supervised visits. This falls short of ensuring that he receive adequate supervision to prevent accidents and, in fact, he was able to obtain drugs while inadequately supervised.

Regardless of whether an accident occurred during this time of inadequate supervision, facility’s failure to supervise the resident as necessary put the facility out of substantial compliance with section 483.25(d). Kenton Healthcare, DAB No. 2186 at 13 (holding that the question is not whether an accident occurred but whether the facility provided adequate supervision). As the court explained in Fal-Meridian, 604 F.3d at 447, uncertainty about whether inadequate supervision caused the resident harm “cannot get the nursing home off the hook.” Rather, the dispositive question is whether the facility’s actions were “consistent with its duty to keep the home as free as possible from hazards that might cause an accident to a resident.”

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Nor am I persuaded by Petitioner’s suggestion that the facility’s duty to protect R5 from illicit substances was somehow less because he had been admitted following hip surgery, not specifically for treatment of his substance use disorder. See P. Opp. at 16. Without regard to the reason for a resident’s admission, the facility must identify potential risks and provide adequate supervision and assistive devices to ameliorate those risks and prevent accidents. Briarwood Nursing Ctr., DAB No. 2115 at 5.

R5’s care plan. As documented above, it is well-settled that a resident’s care plan represents the facility’s judgment about what care and services are needed to keep the resident safe. If facility staff fail to provide care and services in accordance with the resident’s comprehensive assessment and plan of care, it violates section 483.25. White Sulphur Springs Ctr., DAB No.2520 at 6-7 (2013); Deltona Health Care, DAB No. 2511 at 7-8 (2013); Venetian Gardens, DAB No. 2286 at 5 (2009).

Petitioner’s baseline care plan, dated August 5, 2022, indicates that R5 takes methadone because he has a history of substance use disorder. Methadone prevents cravings and withdrawal symptoms. The plan directs staff to administer methadone, as directed; it describes potential problems associated with the drug and the appropriate responses to those problems. CMS Ex. 3 at 2.

The plan identifies, as a concern, R5’s substance use disorder, recognizing his difficulties with refusing illegal substances when the opportunity presents. The plan indicates that the facility will further assess the risk of R5’s obtaining illegal drugs from visitors and others. It cautions that he could be asked to have his possessions or room searched “if the risk of harmful items is suspected.” CMS Ex. 3 at 4. At that time, the plan did not call for supervised visits (because of his inaccurate assessment).

The plan also recognizes that, in light of his substance use disorder and his history, the resident is at risk of an overdose. It describes the symptoms of an opioid overdose and provides staff with instructions on how to respond. CMS Ex. 3 at 16-17.

On September 27, 2022, the facility added an issue to R5’s care plan: “I was found with illicit drugs in my possession, and it is suspected that I sell them to my peers.” CMS Ex. 3 at 20. Among the interventions listed: provide social services and psych support, as needed; complete room searches, when needed; provide supervision for appointments and visits; and provide 1:1 observation, as needed. CMS Ex. 3 at 20.

I note that the supervision requirement incorporates the facility’s policies and procedures for supervision. If the supervision provided does not comply with those policies and procedures, the facility has not followed the resident’s care plan.

On October 4, 2022, the facility amended R5’s care plan to add: “I may tell you things that are not real and may say things about others that are not true. I believe these things

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to be true.” CMS Ex. 3 at 19. Among other interventions, staff are directed to: limit the resident’s exposure to peers or staff about whom he makes statements that may not be true; listen to what the resident is saying and determine if there is any truth to it; if he makes statements about staff that may not be true, provide him with two caregivers; and offer the resident 1:1 visits by the social worker to discuss concerns and issues about others. CMS Ex. 3 at 19.

A social work assessment, dated November 8, 2022, concludes that R5 has the capacity to meet his basic needs in the community. However, the assessment also points out that his recent history of substance use places him “at risk of seeking unescorted exit from a supervised setting.” CMS Ex. 4 at 16.

On November 8, 2022, R5’s care plan was amended to reflect that, on November 6, he overdosed on an illicit substance. CMS Ex. 3 at 15. The plan lists the following interventions:

• Provide the resident with supervised visits
• Monitor the resident for signs and symptoms of overdose;
• Social work would follow up and support, as needed; and
• Provide mental health support and follow up, as needed.

CMS Ex. 3 at 15, 39. Again, providing the resident with supervised visits means following the facility’s policies and procedures for supervised visits.

Because the facility did not properly assess R5 substance use disorder and, for a significant amount of time, his care plan allowed for unsupervised visits, the facility was not taking all reasonable steps to prevent accidents and was thus not in substantial compliance with section 483.25(d).

The Incidents

September 11, 2022. According to a September 11, 2022 nursing note, that morning, R5 was at the nursing station, “yelling and cursing at staff.” He was upset that 15-minute checks had been implemented “due to his unsafe behavior and reports of him distributing drugs to other residents.” He refused staff requests that he stay in his room and became “increasingly threatening.” He went into the lobby and tore up and threw a facility binder. Staff called his nurse practitioner, who directed them to send him to the hospital. CMS Ex. 4 at 7.

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At the hospital, R5 reported that another resident overdosed two hours after he spent time in R5’s room. R5 was then put on “lock-down” and checked every 15 minutes. R5 told the hospital staff that he hadn’t done anything wrong and that what happened to the other resident “had nothing to do with” him. CMS Ex. 7 at 4.

R5 returned to the facility on September 12, 2022, and was again placed on 15-minute checks. CMS Ex. 4 at 7.

In a progress note, dated September 16, 2022 (a Friday), the nurse practitioner reported that R5 “was noted with substance last weekend.” CMS Ex. 2 at 14. The nurse practitioner reported that staff would continue to monitor R5 closely for substance abuse incidents and seek a social work consult for support in combatting the substance abuse. Staff would also monitor R5 with periodic toxicology screens. CMS Ex. 2 at 26.

R5’s care plan was not then amended to reflect the need for increased supervision.

September 27, 2022. A nursing note, dated September 27, 2022, reports that R5 visited the room of a resident (identified as R3) who had been sent out for possible opioid abuse. Staff notified the director of nursing services and searched the room. They found a bag that had contained Heroin/Fentanyl and an unidentified pill. R5 was placed on one-on-one supervision. CMS Ex. 4 at 7. On September 29, 2022, R5 told the social worker that he received hazardous substances from another resident. R5 denied giving the substance to others. CMS Ex. 4 at 3.

A visitor risk assessment, dated September 29, 2022, indicates that R5 had been caught with contraband (hazardous substance) and would be allowed visitors only with supervision. He was placed on one-on-one supervision. CMS Ex. 1 at 8. The following day, he was seen by a physician’s assistant at his behavioral health center. CMS Ex. 5 at 20. In a progress note, dated September 30, 2022, a nurse practitioner noted that R5 had a history of substance abuse and, twice in the previous two weeks, he was “found to be involved in distributing substance to other residents.” CMS Ex. 2 at 18.

Nurses’ notes do not indicate when R5’s level of supervision changed from one-on-one, but an entry dated October 13, 2022, indicates that the interdisciplinary team met and R5’s 15-minute checks were discontinued. CMS Ex. 4 at 6, 10.

November 6, 2022 overdose. At 8:20 p.m. on November 6, 2022, staff found R5 unresponsive. He had no pulse and no respirations. He was suffering from a drug overdose. Staff initiated CPR, administered Narcan (Naloxone) and called 911. They sent R5 to the emergency room. CMS Ex. 4 at 6, 12; CMS Ex. 9 at 1-3. Staff also searched R5’s room, assessing the safety risks as high (which justifies an unapproved room search), and found a small bag of drugs. They notified the police and turned in the bag of narcotics. CMS Ex. 4 at 12; CMS Ex. 16 at 22-23.

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R5 returned to the facility the following morning with a diagnosis of drug overdose. He was put on 15-minute checks. CMS Ex. 4 at 6, 11-12.

In a progress note, dated November 7, 2022, the nurse practitioner reported that R5 had suffered an overdose. When he returned to the facility, he reported that he had received the substance – Fentanyl – from another resident’s visitor. The nurse practitioner described the facility’s plan as: continue Q15 minute checks; continue supervised visits; and reeducate the resident on the danger of using illegal, non-prescribed substances. CMS Ex. 2 at 24.

The social worker interviewed R5, who admitted that he took a substance that was not prescribed and that he overdosed. She placed R5 in the “psych book” for additional evaluation and support. CMS Ex. 4 at 2.

R5 later told Surveyor Predka that his own brother brought four “bundles” (20 bags per bundle) of Fentanyl into the facility but that the drugs were intended for another resident. CMS Ex. 9 at 8.

Surveyor Predka reviewed the “security/receptionist shift to shift report,” dated November 12, 2022. According to the receptionist’s report, R5 advised the security guard that he had overdosed the weekend before and that he obtained the illegal substance from R6. He said that R6 still had the drugs on him. The receptionist reported the encounter to the Nurse Supervisor, who told her that R5 “doesn’t always tell the truth” and that she “could not go by the word of another resident.” The Nurse Supervisor said that there was nothing she could do, according to the receptionist’s report. CMS Ex. 9 at 7; CMS Ex. 16 at 25; see CMS Ex. 9 at 25 (resident list). The facility did not investigate the allegation.

In speaking to Surveyor Predka, the Nurse Supervisor first denied that the receptionist, or anyone else, told her that the resident still had drugs, and then she said she had no memory of that happening. “Nobody told me that the resident still had drugs on him, nobody called me. I don’t remember. If it was reported to me, I would address it.” CMS Ex. 9 at 16; CMS Ex. 16 at 25.

Although he supervised the receptionist and the security guard, the facility’s administrator told the surveyor that he was not aware of the receptionist’s report. Had he known, he’d have made sure the situation was investigated. CMS Ex. 9 at 18; CMS Ex. 16 at 25.

December 11, 2022 incident. On December 11, 2022, R5 and another resident got into an “altercation,” and R5 hit the other resident in the head with his cane. The resident’s head was injured. Police were called. The social worker met with R5 on December 12;

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the resident was not receptive and walked out of her office. The social worker recommended a referral for mental health services and a care plan revision, among other interventions. CMS Ex. 4 at 5, 15. R5 continued on 15-minute checks. CMS Ex. 4 at 5.

A nurse’s note, dated December 14, 2022, describes an unpleasant altercation between the nurse and R5. R5 was using a crutch that had not been ordered. The nurse offered him his walker. He refused to return the crutch, complaining that they had taken away his cane, which they had confiscated because he used it as a weapon. He became irate, claiming that he could use anything as a weapon. CMS Ex. 4 at 5. Later that day, R5 was again placed on 15-minute checks after another resident reported that he had been smoking crack overnight. R5 denied the allegation but refused to submit to a room search. CMS Ex. 4 at 4.

Overdoses involving other residents. Four additional overdoses, one fatal, occurred between November 12 and December 31, 2022. CMS Ex. 16 at 25-26. Evidence describing the circumstances underlying most of these incidents is sparce. However, Petitioner does not deny that they occurred.

Resident 1 (R1). Among the few documents describing the overdoses are records from emergency medical services, dated December 14, 22, and 31, 2022, for R1, a 41-year-old woman. According to these records, R1 had an extensive history of drug abuse and was admitted to the facility so that she could receive antibiotics via a PICC (peripherally inserted central catheter) line. CMS Ex. 15 at 11. The documents describe three incidents:

• On December 14, 2022, witnesses observed R1 smoking crack. Although she denied “any and all” drug use, police found drugs and drug paraphernalia on her person, and facility staff found drugs in her purse. Staff insisted that she be sent to the hospital before they would even consider allowing her to remain at the facility. The EMTs (emergency medical technicians) took her to the hospital. CMS Ex. 15 at 11.
• On December 22, 2022, EMTs were again called to the facility. Staff found R1 on the floor next to her bed, unresponsive, with agonal4  respirations. Staff administered Naloxone and called 911. When the EMTs arrived, R1 had recovered and had become aggressive and combative, demanding to be left alone. Facility policy requires that a resident be sent to the hospital after a Naloxone treatment, and R1 was sent to the hospital. Hospital personnel reported that she had been transported to the hospital for the same issue “multiple times in recent weeks.” CMS Ex. 15 at 5.

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• On December 31, 2022, R1 had an abnormally low respiratory rate and pinpoint pupils. She admitted to snorting Fentanyl. Staff again administered Narcan and sent her to the emergency room. CMS Ex. 15 at 1.

R2’s Fentanyl intoxication, cardiac arrest, and death. R2 was a 53-year-old man, who resided in the facility. On December 29, 2024, he went into cardiac arrest. The EMTs were called, and he was taken to the hospital. CMS Ex. 14 at 1, 5. On January 5, 2023, he died of acute intoxication, including Fentanyl. CMS Ex. 14 at 15.

Standard of care. Petitioner argues that an evidentiary hearing is necessary to determine the “applicable professional standard of care related to a nursing facility’s attempts to protect its residents from injury or death” caused by drug overdoses. P. Opp. at 21. In fact, no one disputes Petitioner’s assertions as to the standard of care. I accept that the facility’s written policies represent that standard. Nor is anyone faulting the facility because it failed to meet some unattainable standard; rather, the facility was not in substantial compliance because its staff did not follow some uncomplicated instructions for supervising its at-risk residents. See Kenton Healthcare, DAB No. 2186 at 13 (holding that section 483.25(d) does not focus on the accident itself but on whether the facility has provided adequate supervision).

Facility staff’s disregard of facility policies. The evidence – which Petitioner does not challenge – establishes that staff disregarded facility policies. Consistent with the administrator’s statements in his memos of August 5 and September 27, 2022, R5 described, to Surveyor Predka, the methods by which the residents and their cooperative family members brought drugs into the facility:

• Fast food bags: a family member would hide Fentanyl at the bottom of a bag of fries. When Security checked the bag of food, they would see only the fries. CMS Ex. 9 at 8.
• Trips to the bathroom: R5 explained that a family member would ask to use his bathroom. In the bathroom, he would hide the drugs behind the ceiling tiles or in the heater/radiator. CMS Ex. 9 at 8. This was the means by which R5’s brother sneaked drugs into the facility on November 6, allowing for the resident’s overdose. Although his visits were supposed to be supervised, staff allowed his brother to go into R5’s room. Knowing that a “guy will not follow another guy into the bathroom,” his brother went into the bathroom and hid the drugs in the ceiling. A second resident retrieved the drugs and gave R5 five of the bags. CMS Ex. 9 at 9; CMS Ex. 23 at 3 (Predka Decl. ¶ 10i, j).

The security guard, who was on duty on November 6, confirmed R5’s report. He admitted that, rather than holding the meeting in one of the designated rooms (as required by the facility policy), he allowed R5 and his visitor to “meet quickly in the hallway.”

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The three then went into R5’s room for “about” 30 seconds. The visitor “did go to the bathroom in [R5’s] room” but could not have been in there for more than 25 seconds. The guard admitted that something was “definitely” amiss in how the two interacted. CMS Ex. 9 at 12; CMS Ex. 16 at 23.

The guard also told Surveyor Predka that he didn’t know that supervised visits were not supposed to take place in the resident’s room. After the November 6 incident, he learned about the requirement that supervised visits take place in the conference room or the room behind the receptionist. CMS Ex. 9 at 13-14; CMS Ex. 16 at 23. The facility’s administrator suggested to Surveyor Predka that the guard might have been trained at a sister facility, so was unaware of the supervised visits policy. CMS Ex. 9 at 20; CMS Ex. 16 at 24.

Neither the security guard nor the administrator testified and thus did not deny making these statements. Nor has Petitioner denied that they made them. I can therefore consider them accurate. See Beatrice State Development Ctr., DAB No. 2311 at 17, 18 (pointing out that the facility could have but did not present testimony that refuted the statements the surveyors claimed they made); Omni Manor Nursing Home, DAB No. 1920 at 11 (holding that statements of facility employees to the surveyors may be admitted in an administrative proceeding and may constitute substantial evidence).

Thus, the undisputed evidence establishes that, contrary to the facility’s written policies and the administrator’s unambiguous instructions, the security guard on duty on November 6:

• Allowed a resident to meet his visitor in spaces that were not the conference room nor the room behind the receptionist area, notwithstanding a facility policy that limited visits to one of those two rooms and emphasized that there are no exceptions (without specific management approval); and
• Allowed the visitor to enter the resident’s bathroom, notwithstanding a facility policy emphasizing that the bathroom next to the administrator’s office would be the ONLY bathroom used, no exceptions.

CMS Ex. 9 at 12; CMS Ex. 16 at 23; see CMS Ex. 17 at 2, 7. This puts the facility out of substantial compliance with section 483.25(d).

I accept, for purposes of summary judgment, the security guard’s claims as to the short duration of R5’s meetings with his visitor – “quickly in the hallway,” making “no physical contact” and “about 30 seconds” in the resident room. I also accept that the visitor was alone in the bathroom for “no more than 25 seconds” and that the door to the bathroom “was not completely closed.” CMS Ex. 9 at 12. I also accept that, although the guard did not observe the visitor in the bathroom, he heard what he thought was the

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sound of the visitor urinating. Id. However, notwithstanding these efforts to minimize the significance of the guard’s failing to follow the facility’s strict policies on supervised visits, there is no question that he gave the resident and his visitor opportunities to get the drugs into the facility that would not have been there had guard followed the policies. As Witness Allen explained, and the facility’s administrator recognized, those suffering from substance use disorders “find new and innovative ways to procure” drugs. P. Ex. 1 at 2 (Allen Decl. ¶ 9). For that reason, staff had to “be vigilant” and to follow the facility’s policies meticulously. CMS Ex. 17 at 1.

Although, as noted, Petitioner did not submit the security guard’s testimony nor any other evidence to refute the evidence that he was not properly trained as to the policies for supervised visits, it questions whether he made such a statement: “It seems questionable that an individual who provided detailed information regarding the professional education that he exhibited during a supervised visit would have then said that he never received any education on supervised visits.” P. Opp. at 9. This argument fails for many reasons.

• The so-called “detailed information” the guard provided establishes that he did not follow the policy.
• If, in fact, the guard had been properly trained, it would not have been difficult for Petitioner to present evidence to establish that fact, such as testimony from the guard or the administrator denying the statements they made to the surveyor or records of staff training attendance. But it did not.
• Most important, even if I agreed that the guard had been properly trained, that does not help Petitioner’s case. Either the guard was not trained and was thus not aware of the policies, or he was trained and chose to disregard the policies. Either option puts the facility out of substantial compliance with section 483.25(d).

Petitioner also argues that staff’s failing to follow specific instructions for supervising residents does not put the facility out of substantial compliance. Citing provisions of the State Operations Manual, Petitioner argues that drug overdoses are not “accidents” within the meaning of section 483.25(d). P. Opp. at 14-15. According to Petitioner, because R5’s overdose was neither “unintentional” nor “unexpected,” it cannot be considered an accident: “[I]t was the result of an intentional, premeditated, deceptive, conspiratorial act.” P. Opp. at 2-4, 15; see P. Ex. 1 at 2 (Allen Decl. ¶ 9). I reject this thinking.

Blaming the resident seems to disregard Witness Allen’s testimony as to the “insidious and self-destructive nature of addiction.” P. Ex. 1 at 1 (Allen Decl. ¶ 7).

Moreover, I am not bound by the provisions of the State Operations Manual. The Departmental Appeals Board has repeatedly observed that administrative law judges (and the Board) are bound by the statutes and regulations, not the State Operations Manual,

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whose provisions are “instructive” but not binding. See Beverly Health and Rehabilitation Services v. Thompson, 223 F. Supp.2d 73, 99-106 (D.D.C. 2002); Countryside Rehab. and Health Care, DAB No. 2853 at 25; Kindred Transitional Care and Rehab. – Greenfield, DAB No. 2792 at 20 (2017); Oakwood Community Ctr., DAB No. 2214 at 16 (2008); Aase Haugen Homes, Inc., DAB No. 2013 at 15 (2006). This approach comports with the Supreme Court’s comments as to the value of sub-regulatory guidance. Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019).

In any event, nothing in the cited provisions of the State Operations Manual – or any other authority – gives the facility a pass on properly supervising its residents. The Board long ago resolved that “accidents” are events that can cause injury to residents and can be prevented by supervision. Woodstock Care Ctr., DAB No. 1726 at 21, 36. Allowing dangerous substances into the facility can injure vulnerable residents and can be prevented by supervision.

I accept the testimony of Petitioner’s witness that individuals who suffer substance use disorder will attempt to obtain illicit drugs, and their use of those drugs is likely to cause them serious harm. But I do not agree that these stark realities relieve the facility of its responsibility to provide adequate supervision. See P. Ex. 1 at 1 (Allen Decl. ¶ 6) (asserting that individuals with substance use disorder are highly likely to devote significant time and effort attempting to obtain opioids and other addictive substances). As the Board has explained (and, as I noted above), section 483.25(d) focuses on whether the facility has provided adequate supervision, not on whether an accident has occurred. Kenton Healthcare, DAB No. 2186 at 13; accord Fal-Meridian, 604 F.3d at 447.

Because staff did not follow the facility’s policies for supervised visits, the facility was not in substantial compliance with section 483.25(d).

The uninvestigated report. In another respect the facility did not take all reasonable steps to protect its residents from illicit substances. The administrator’s memos emphasize that the receptionist and security both “play a key role” in preventing the introduction of illicit substances into the facility. CMS Ex. 17 at 1. The facility’s administrator supervised the receptionist and the security guards, yet he was unaware of the receptionist’s November 12, 2022 report, and, as a result, no one investigated its allegations. CMS Ex. 9 at 18; CMS Ex. 16 at 25.

As discussed above, in a written document, dated November 12, 2022, the facility’s receptionist reported that R5 told the security guard that he had overdosed the weekend before (which is verifiably true – CMS 4 at 6, 12; CMS Ex. 9 at 1-3); that another resident had supplied the drugs; and that the resident still had drugs on him. R5’s care plan required staff to determine if the resident’s statements were true. CMS Ex. 3 at 19. No one did that. The receptionist wrote that she had reported the incident to the nurse

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supervisor, who took no action. CMS Ex. 9 at 7. The facility’s administrator admitted that he was unaware of the allegation, which should have been investigated.

I must draw every reasonable inference in the light most favorable to the non-moving party. However, neither version of the events surrounding the receptionist’s report is particularly favorable to the facility. Either the receptionist did not report the incident to the nurse supervisor or she reported the incident and the nurse simply discounted it. In either case, a staff member did not act appropriately.

Nevertheless, no one disputes that the receptionist recounted the incident in a written shift-to-shift report. And the solid and uncontradicted evidence – which Petitioner has not challenged – establishes that facility management did not review the report and did not investigate its allegations. Management was not even aware of the report’s allegations until the surveyor pointed them out. This also establishes that the facility was not taking reasonable steps to prevent accidents, which puts it out of substantial compliance with section 483.25(d).

Thus, viewing the entire record in the light most favorable to Petitioner, and drawing all reasonable inferences in its favor, a rational trier of fact could not find that the facility was in substantial compliance with section 483.25(d)(1) and (2).

2. The undisputed evidence establishes that the facility’s substantial noncompliance with 42 C.F.R. § 483.25(d)(1) and (2) posed immediate jeopardy to resident health and safety.

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). Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination. The burden is on the facility to show that CMS’s determination is clearly erroneous. Consulate Healthcare of Jacksonville, DAB No. 3119 at 33 (2023); Woodland Oaks Healthcare Facility, DAB No. 2355 at 17-18 (2010); Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing & Rehab Center – Johnston, DAB No. 2031 at 17-18, aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007)).

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.” Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000));

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Daughters of Miriam Center, DAB No. 2067 at 7, 9 (2007); see Yakima Valley School, DAB No. 2422 at 8 (2011) (holding that the “clearly erroneous” standard is highly deferential and “places a heavy burden on the facility to upset CMS’s finding regarding the level of noncompliance”).

That the facility’s substantial noncompliance with section 483.25(d) posed immediate jeopardy to resident health and safety is not a close question. Petitioner’s witness described the “insidious and self-destructive nature of addiction” and explained that this risk is exacerbated by the “potency and unpredictability of illicitly produced Fentanyl.” P. Ex. 1 at 1 (Allen Decl. ¶ 7). The facility did not take all reasonable steps to keep this potentially deadly substance away from the facility’s vulnerable residents. This failure was likely to cause the facility’s residents, including R5, serious injury (or even death). In fact, because he was able to obtain drugs that were smuggled into the facility, R5 suffered actual harm – a drug overdose.

The facility’s substantial noncompliance caused actual harm to at least one vulnerable facility resident and was likely to cause serious harm to others. Petitioner has thus not met its burden of establishing that CMS’s immediate jeopardy determination is clearly erroneous.

3. CMS’s determinations as to the duration of the facility’s substantial noncompliance and immediate jeopardy are consistent with statutory and regulatory requirements.

Once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again. Ridgecrest Healthcare Ctr., DAB No. 2493 at 2-3 (2013); Taos Living Ctr., DAB No. 2293 at 20 (2009); Premier Living & Rehab Ctr., DAB No. 2146 at 23 (2008); Lake City Extended Care, DAB No. 1658 at 12-15 (1998). The burden is on the facility to prove that it is back in compliance, not on CMS to prove that the deficiencies and the immediate jeopardy continued to exist. West Texas LTC Partners, Inc., 843 F.3d at 1049; Asbury Care Ctr. at Johnson City, DAB No. 1815 at 19-20 (2002).

A facility’s return to substantial compliance usually must be established through a resurvey. 42 C.F.R. § 488.454(a); Ridgecrest, DAB No. 2493 at 2-3. The facility must show that the incidents of noncompliance have ceased and that it has implemented appropriate measures to ensure that similar incidents will not recur. Nursing Ctr., DAB No. 2433 at 15 (2011) (citing Life Care Ctr. of Elizabethton, DAB No. 2356 at 16 (2011); accord 42 C.F.R. § 488.454(a) and (e); Hermina Traeye Memorial Nursing Home, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation “acceptable by CMS” showing that it was in substantial compliance and was capable of remaining in

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substantial compliance on the earlier date); Cross Creek Care Center, DAB No. 1665 (1998).

There is no requirement that a remedy’s duration coincide with particular adverse events. Consulate Healthcare of Jacksonville, DAB No. 3119 at 33. A facility’s allegation that it reduced the threat to one resident, without establishing that it completed actions to ensure the protection of all residents, does not show that CMS erred in determining the duration of immediate jeopardy. Id. at 22.

Here, the facility has not met its burden of establishing that it returned to substantial compliance any earlier than January 30, 2023. Its deficiencies were not the type (like a leaky roof or a broken dishwasher) that lend themselves to a quick fix. As shown by the discussion above, the facility’s problems were not limited to one incident involving

one resident (as Petitioner suggests) or one employee; the problems were systemic and long-standing and involved all levels of facility personnel:

• As early as August 5, 2022, a resident obtained illicit substances after staff allowed visitors into the resident’s room. CMS Ex. 17 at 1.
• Illicit drugs continued to enter the facility through the front door, as the facility’s administrator reported in his September 27, 2022 memo. CMS Ex. 18.
• The facility inaccurately assessed R5 at the time of his admission, which resulted in unrestricted visits. This continued even after he was caught distributing drugs to other residents on September 11, 2022. CMS Ex. 4 at 11; CMS Ex. 9 at 1, 21.
• The facility did not consider altering R5’s level of supervision in response to his August 22 disregard for the smoking rules. CMS 4 at 3.
• R5 had an inadequate care plan in place for many weeks. The facility did not amend the care plan to require supervised visits until the second time R5 was found with illicit substances (on September 27). CMS Ex. 4 at 7.
• Either the receptionist did not timely report R5’s conversation with the security guard on November 12 or she reported it to the nurse supervisor, who took no action.
• The facility disregarded the receptionist’s November 12, 2022 shift-to-shift report. As late as January 30, 2023, facility management was not aware of the incident described in the report. CMS Ex. 16 at 25.

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• Although the facility seems to disavow responsibility for R1’s multiple drug overdoses (December 14, December 22, and December 31), it has not explained how R1 consistently obtained those drugs or shown that she was properly supervised.
• Nor has the facility come forward with any evidence explaining how R2 obtained the drugs that led to his heart attack and death on December 29.

Petitioner suggests that the facility returned to substantial compliance on November 8, 2022, because it “provided education to the security personnel and receptionists regarding the process for supervised visits, audits were conducted, and the incident was reviewed by the QAPI.” P. Opp. at 24. Petitioner submits no underlying evidence describing any of these actions.5 See Ill. Knights Templar, DAB No. 2274 at 4; Livingston Care Ctr., DAB No. 1871 at 5 (holding that, to avoid summary judgment, the non-moving party may not simply rely on denials but must furnish admissible evidence of a dispute concerning a material fact).

While training might, if properly implemented, help the facility achieve substantial compliance, by itself, training does not establish substantial compliance. Until the facility can demonstrate that its training and other interventions are effective, i.e., that staff capably followed the training, that management put effective monitoring tools in place, and that those interventions resolved the problem, the facility has not met its significant burden of demonstrating that it has alleviated the level of threat to resident health and safety. Oceanside, DAB No. 2382 at 19-20; Premier Living and Rehab. Ctr., DAB CR1602 (2007), aff’d, DAB No. 2146 at 24 (2008); See CMS Ex. 16 at 17-18 (reflecting that corrective action includes training followed by audits of supervised visits and locations and that these corrections would be completed no sooner than January 31).

Petitioner does not explain the incidents that occurred after R5’s November 8 overdose but essentially disavows any responsibility for them. Petitioner argues that the surveyors did not investigate those events, which, in any event, did not “form the basis for the finding of immediate jeopardy in the Form 2567.” P. Opp. At 23-24. These arguments fail for the following reasons:

• Neither CMS nor the state surveyors is required to investigate and explain episodes of drug overdoses or any other accidents. By showing that facility residents had access to drugs and were able to ingest them, CMS has met its burden. To avoid summary judgment, Petitioner must come forward with

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• evidence of specific facts showing that a dispute exists. Tex. LTC Partners, DAB No. 2652 at 6; Ill. Knights Templar, DAB No. 2274 at 4; Vandalia Park, DAB No. 1939; Livingston Care Ctr., DAB No. 1871 at 5. Petitioner has come forward with no such evidence.
  
  Ultimately, to show that it was in substantial compliance, the facility must come forward with evidence establishing that it was taking all reasonable steps to prevent the accidents. Petitioner has not produced that evidence (e.g., no witness testimony, no accident investigation reports).
• With respect to Petitioner’s complaint as to the contents of the survey report form, it is well-settled that, so long as Petitioner has notice and a meaningful opportunity to be heard, CMS may raise issues and present evidence of facts not specifically raised in the statement of deficiencies. Life Care Ctr. of Bardstown v. Secretary, 535 F. App’x 468 (6th Cir. 2013).

Thus, Petitioner has not established that the facility achieved substantial compliance any earlier than January 30, 2023.

4. The CMP imposed – $8,265 per day for the period of immediate jeopardy – is reasonable.

To determine whether a civil money penalty is reasonable, I apply 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) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating factor. The factors 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.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors. I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion. Barn Hill Care Ctr., DAB No. 1848 at 21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22, et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 (2001); CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

I determine whether a penalty is reasonable based on the per-day penalty, not the total accrued penalty. Crawford Healthcare and Rehabilitation, DAB No. 2738 at 20 (2016).

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The burden is on the facility “to demonstrate, through argument and submission of evidence addressing the regulatory factors, that a reduction is necessary to make the CMP amount reasonable.” Heritage Plaza Nursing Ctr., DAB No. 2829 at 22 (2017) (quoting Oaks of Mid City Nursing and Rehab. Ctr., DAB No. 2375 at 26-27 (2011)).

Penalties are inflation-adjusted and change annually. The amount is determined as of the date the penalty is assessed, in this case, February 28, 2023. CMS Ex. 21; 87 Fed. Reg. 15,100, 15,111-12 (Mar. 17, 2022). For each day of immediate jeopardy, CMS imposed a CMP of $8,265 per day, which is barely above the minimum amount for situations of immediate jeopardy ($7,317 to $23,989). 42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. at 15,111-12.

Considering the relevant factors, this amount is reasonable, and, because Petitioner has proffered no evidence sufficient to create a genuine dispute of facts affecting how the regulatory factors should be assessed, CMS is entitled to summary judgment on this issue. Vibra Hospital, DAB No. 3094 at 30; Crawford Healthcare, DAB No. 2738 at 19.

The facility has a significant history of substantial noncompliance, including substantial noncompliance with the quality-of-care regulation:

• For a survey completed on April 19, 2022, the facility was not in substantial compliance with sections 483.12(c) (Tag F609 – freedom from abuse, neglect, and exploitation: reporting alleged violations) and 483.21(b) (Tag F657 – comprehensive care planning: timing, development, and revisions), both cited at scope and severity level D. CMS Ex. 26 at 1.6
• For a survey completed on April 12, 2022, the facility had a significant number of Life Safety Code violations (10), all cited at scope and severity level F (widespread substantial noncompliance that causes no actual harm, with the potential for more than minimal harm). CMS Ex. 26 at 1.
• For a survey completed on March 18, 2022, the facility was not in substantial compliance with sections 483.10(a) (Tag F550 – resident rights), 483.12(c) (Tag F609 – freedom from abuse, neglect, and exploitation: reporting alleged violations), and 483.12(c) (Tag F610 – freedom from abuse, neglect, and exploitation: reporting and investigating). CMS Ex. 26 at 1.

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• For a survey completed on January 19, 2022, the facility was not in substantial compliance with section 483.10(a) (Tag F550 – resident rights), cited at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm). CMS Ex. 26 at 1.
• For a survey completed on December 13, 2021, the facility was not in substantial compliance with sections 483.25 (Tags F684 – quality of care), cited at scope and severity level G (isolated instance of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety). CMS Ex. 26 at 1.
• For a survey completed on January 27, 2021, the facility was not in substantial compliance with sections 483.10 (Tag F563 – resident rights: right to receive /deny visitors) and 483.10 (Tag F580 – resident rights: notification of changes), cited at scope and severity level D. CMS Ex. 26 at 2.
• For a survey completed on July 14, 2020, the facility was not in substantial compliance with section 483.80 (Tag F880 – infection control: prevention and control program), cited at scope and severity level E. CMS Ex. 26 at 2.
• For a survey completed on May 11, 2020, the facility was not in substantial compliance with section 483.80 (Tag F880 – infection control: prevention and control program), cited at scope and severity level E. CMS Ex. 26 at 2.
• For a survey completed on February 14, 2020, the facility was not in substantial compliance with section 483.50 (Tag F770 – laboratory services), cited at scope and severity level D. CMS Ex. 26 at 2.
• For a survey completed on January 2, 2020, the facility was not in substantial compliance with section 483.25 (Tags F684 – quality of care), cited at scope and severity level D. CMS Ex. 26 at 2.
• For a survey completed on August 30, 2019, the facility was not in substantial compliance with 10 health regulations, including two quality-of-care deficiencies, section 483.25 (Tags F684 and F686), cited at scope and severity level D. CMS Ex. 26 at 3.
• On August 27, 2019, the facility had one Life Safety Code violation, cited at scope and severity level D. CMS Ex. 26 at 3.

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• For a survey completed on June 18, 2019, the facility was not in substantial compliance with sections 483.10 (Tag F580 – resident rights) and 483.25 (Tag F684 – quality of care), cited at scope and severity level D. CMS Ex. 26 at 3.
• For a survey completed March 4, 2019, the facility was not in substantial compliance with sections 483.25 (Tags F684 and F698), and 483.50 (Tag F773 – laboratory services), all cited at scope and severity level D. CMS Ex. 26 at 3.
• For a survey completed on November 27, 2018, the facility was not in substantial compliance with section 483.21 (Tag F656 – resident care plans), cited at scope and severity level D. CMS Ex. 26 at 3.
• For a survey completed July 27, 2018, the facility was not in substantial compliance with the quality-of-care regulation, section 483.25 (Tag F689), cited at scope and severity level G. CMS Ex. 26 at 4.
• On July 25, 2018, the facility had one Life Safety Code violation, cited at scope and severity level D. CMS Ex. 26 at 4.

By itself, the facility’s history – including its repeated substantial noncompliance with the quality-of-care regulation – justifies a substantial increase in the penalty amounts.

With respect to the facility’s financial condition, it is well-settled that the facility has the burden of proving that paying the CMP would render it insolvent or would compromise the health and safety of its residents. Van Duyn Home and Hosp., DAB No. 2368 (2011); Gillman Care Ctr., DAB No. 2357 (2010). Petitioner does not claim that its financial condition affects its ability to pay the penalty.

Applying the remaining factors, as I discussed in some detail above, allowing dangerous drugs into the facility put the facility’s vulnerable residents at significant risk. The facility had specific policies in place that were aimed at keeping the drugs out. Among the policies were some straightforward instructions: visits to residents with substance use disorder must be supervised; such visits must be limited to one of two rooms; visitors may use only one designated bathroom – not the bathroom in the resident’s room. Yet, staff disregarded the policies (or were not aware of them), for which the facility is culpable.

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Conclusion

CMS is entitled to summary judgment because the undisputed evidence establishes that, from January 9 through 30, 2023, the facility was not in substantial compliance with the quality-of-care requirements, 42 C.F.R. § 483.25(d)(1) and (2). That deficiency posed immediate jeopardy to resident health and safety. The CMP imposed – $8,265 per day for 22 days of immediate jeopardy – is reasonable.