Life Care Center of Citrus County, DAB CR6752 (2025)

DECISION

Petitioner, Life Care Center of Citrus County, is a long-term-care facility located in Florida that participates in the Medicare program.  Following a survey completed on May 12, 2023, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare program requirements and that its deficiencies posed immediate jeopardy to resident health and safety.  CMS imposed civil money penalties (CMPs) of $13,695 per day for eight days of immediate jeopardy and $360 per day for 42 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner appealed.

As explained herein, I deny Petitioner’s motion for remand, and for refund of civil money penalty, grant CMS’s motion for summary judgment, affirm the basis for CMS’s imposition of penalties, and find the CMPs selected by CMS reasonable.

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I.     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 fifteen 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).

Pursuant to section 1135(b) of the Act, CMS prioritized infection control surveys, creating a survey tool that focused on infection control, and, specifically, on critical elements associated with the transmission of Covid-19.  Facilities were expected to comply with CMS guidance in effect at the time of the survey.

The surveys.  This case involves two surveys, a recertification survey completed May 12, 2023 and a revisit survey completed on July 7, 2023.

On May 8, 2023, surveyors from the Florida Agency for Health Care Administration (state agency) began an unannounced recertification survey, which they completed on May 12, 2023.  Based on the survey findings, CMS determined that the facility was not in substantial compliance with:

• 42 C.F.R. § 483.80(a)(1)(2)(4)(e)(f) (Tag F880 - infection control – prevention and control program) cited at scope and severity level K;
• 42 C.F.R. § 483.12 (Tag F600 - free from abuse, neglect, and exploitation) cited at scope and severity level K;
• 42 C.F.R. § 483.75(c)(d)(e)(g)(2)(i)(ii) (Tag F867 – quality assurance and performance improvement: quality assessment and assurance), cited at scope and severity level K;
• 42 C.F.R. § 483.70 (Tag F835 – administration), cited at scope and severity level K;

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• 42 C.F.R. § 483.25(i) (Tag F695 – respiratory/tracheostomy care and suctioning), cited at scope and severity level D.1

CMS Ex. 1; CMS Ex. 2 at 1.

Surveyors returned to the facility and completed a follow-up survey on July 7, 2023.  The revisit survey found that Petitioner had achieved substantial compliance on June 24, 2023.  CMS Ex. 2.

Based on the deficiencies cited, CMS has imposed against the facility penalties of $13,695 per day for eight days of substantial noncompliance that posed immediate jeopardy to resident health and safety (May 4, 2023 through May 11, 2023) and $360 per day for 42 days of substantial noncompliance that did not pose immediate jeopardy (May 12, 2023 through June 23, 2023).  CMS Ex. 2 at 2.

Petitioner appealed.

CMS submitted a pre-hearing brief and motion for summary judgment (CMS Br.) and 71 exhibits (CMS Exs. 1-71).  Petitioner submitted a pre-hearing brief (P. Br.) and 17 exhibits (P. Exs. 1-17).   In the absence of any objections, I admit into evidence CMS Exs. 1-71 and P. Exs. 1-17.

CMS also submitted one proposed witness who Petitioner requested to cross examine.  Petitioner submitted five proposed witnesses.  CMS did not request cross examination.

Motion for Remand, and for Refund of Civil Money Penalty.  Following the closing of briefing, Petitioner filed a motion seeking remand of this case to CMS and a refund of the CMP imposed in this case.  Petitioner argues that it is entitled to a jury trial.  Petitioner premises this argument on Sec. & Exch. Comm’n v. Jarkesy, 603 U.S. 109 (2024).  However, in a recent case, the Departmental Appeals Board held that:

The Court did not hold that every agency’s attempt to impose and enforce CMPs necessarily is, like the SEC’s action, “a common law suit in all but name” that “must be adjudicated in Article III courts.”  Jarkesy, 144 S. Ct.  at 2136.  On the contrary, the Court acknowledged the long-established “public rights exception,” under which “Congress may assign [a] matter for decision to an agency without a jury, consistent with the Seventh Amendment,” and extensively discussed the Court’s precedents applying that exception.  Id. at 2131-34.

The Oaks, DAB No. 3160 at 27 (2024).

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I note that Petitioner’s motion assumes that the holding in Jarkesy requires a jury trial for all CMPs imposed by federal agencies when the CMPs have a punitive or remedial purpose. The origin, purpose, and context for CMPs imposed on skilled nursing facilities are significantly different than those imposed by the Securities and Exchange Commission based on securities fraud.

Further, I deny Petitioner’s motion because I do not have authority to remand this matter to CMS with an order to pay Petitioner money that CMS is holding in escrow. My independent remand authority is limited to remanding a case to CMS for CMS to consider a new issue and, if appropriate, issue a new determination.  42 C.F.R. § 498.56(d).  Petitioner does not seek a new CMS determination; rather, it wants me to order CMS to return funds held in escrow. Thus, Petitioner’s request is outside of my authority.

II.     Issues

The issues are:

• Whether summary judgment is appropriate;
• Whether the facility was in substantial compliance from May 4, 2023 through June 23, 2023, with Medicare program requirements;
• If, from May 4, 2023 through May 11, 2023, the facility was not in substantial compliance with program requirements, whether its deficiencies then posed immediate jeopardy to resident health and safety; and
• If the facility was not in substantial compliance with program requirements, whether the penalties imposed – i.e. $13,695 per-day for eight days of immediate jeopardy and $360 per day for 42 days of substantial noncompliance that did not pose immediate jeopardy – are reasonable?

III.     Jurisdiction 

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

IV.     Standard for summary judgment

Summary judgment is appropriate in cases where 42 C.F.R. Part 498 applies if there is no genuine dispute of any material fact and the moving party is entitled to judgment as a matter of law.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 750 (6th Cir.

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2004); Civ. Remedies Div. P. § 19(a).  A “genuine” dispute exists if “the evidence is such that a reasonable [trier of fact] could return a verdict for the nonmoving party,” (Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)), and a “material” fact is one “that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010).

To obtain summary judgment, the moving party must show it is entitled to judgment as a matter of law because there is no genuine dispute of material fact requiring an evidentiary hearing to resolve.  Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 5 (2012).  If the moving party meets this initial burden, the non-moving party must “come forward with ‘specific facts showing that there is a genuine issue for trial.’”  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986).  “To defeat an adequately supported summary judgment motion, the non-moving party may not rely on the denials in its pleadings or briefs, but must furnish evidence of a dispute concerning a material fact — a fact that, if proven, would affect the outcome of the case under governing law.”  Senior Rehab., DAB No. 2300 at 3.

In evaluating a motion for summary judgment, an ALJ does not address credibility or evaluate the weight of conflicting evidence.  Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009).  Rather, in examining the evidence to determine the appropriateness of summary judgment, an ALJ must draw all reasonable inferences in the light most favorable to the non-moving party.  See Brightview Care Ctr., DAB No. 2132 at 10 (2007) (upholding summary judgment where inferences and views of non-moving party are not reasonable).  “[A]t the summary judgment stage[,] the judge’s function is not . . . to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986).  Drawing factual inferences in the light most favorable to the non-moving party does not require me to accept the non-moving party’s legal conclusions.  Cedar Nursing Home, DAB No. 2344 at 7 (2010).

V.     Discussion

The May 12, 2023 Survey.

1. The facility was not in substantial compliance with 42 C.F.R. § 483.80(a) because, contrary to facility policies and Center for Disease Control and Prevention (CDC) guidelines, it did not post accurate or sufficient signs about the COVID-19 outbreak; did not implement the correct transmission based precautions for COVID-19; did not timely or properly cohort residents; and because staff misused personal protective equipment (PPE).2

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A.  Program requirements:  Section 1819(d)(3) of the Social Security Act mandates that a skilled nursing facility must (A) establish and maintain an infection control program to provide a “safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection,” and (B) be designed, constructed, equipped, and maintained in a manner that protects the health and safety of residents, personnel, and the general public.

Consistent with section 1819(d)(3), 42 C.F.R. § 483.80 (Tag F880) requires the facility to establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.

The program must include:

1) a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon the facility assessment conducted according to § 483.70(e) and following accepted national standards;3

2) written standards, policies, and procedures for the program, which must include: 

i) a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;

ii) when and to whom possible incidents of communicable disease or other infections should be reported;

iii) standard and transmission-based precautions to be followed to prevent spread of infections;

iv) when and how isolation should be used for a resident, including:

A) the type and duration of the isolation, depending upon the infectious agent or organism involved: and

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B) a requirement that the isolation should be the least restrictive possible for the resident under the circumstances.

v) the circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and

vi) the hand hygiene procedures to be followed by staff involved in direct resident contact.

*  *  *  *  *

4) a system for recording incidents identified under the infection prevention and control program and the corrective actions to be taken by the facility.

The facility must also conduct an annual review of its infection prevention and control program and update the program, as necessary.

The infection-control regulation thus requires that the facility have written policies in place, and that it implements those policies.  If it does not, it violates section 483.80(a).4  Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017); Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014).5

B.  Facility policy:  Infection Prevention and Control Program (IPCP) and Plan.  In a policy dated January 21, 2019 and revised January 25, 2023 (which was in effect during the May 2023 survey), the facility put into place an infection prevention and control program “to prevent, recognize, and control the onset and spread of infection.”  CMS Ex. 50 at 1.

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The policy calls for ensuring that staff follow the IPCP’s policies including hand hygiene and appropriate use of PPE.  CMS Ex. 50 at 3.  It also states that the facility administration should ensure that current infection control standards of practice are based on recognized guidelines and incorporated into the plan.  Id.  The plan also called for the assignment of one or more individuals with training in infection control to provide on-site management of the IPCP.  Id. at 2.

Facility policy:  Coronavirus (COVID-19) (SARS-CoV-2).  In a separate policy dated February 28, 2020 and revised April 4, 2023 (which was in effect during the May 2023 survey), the facility put into place an infection prevention and control program to address Covid-19.  CMS Ex. 52 at 1.  The policy called for the posting of signs or posters at the entrance and in strategic places with instructions about current infection prevention and control recommendations.  Id. at 6.  The policy provided examples of strategic places to include waiting areas and elevators.  Id.  The policy also called for the facility to provide visitors with education on hand hygiene, minimizing surface touches and the use of personal protective equipment (PPE) consistent with current CDC guidelines.  Id.  The facility was also required to maintain an inventory of PPE in the facility and make PPE available in areas where resident care is provided.  Id. at 7.  The policy established that staff caring for residents with confirmed COVID-19 cases were required to use full PPE to include gowns, gloves, eye protection, and a NIOSH approved or equivalent respirator.  Id. at 9.

The facility’s policy stated that a patient with a confirmed or suspected COVID-19 infection should be placed in a single-person room with the door kept closed and a dedicated bathroom.  CMS Ex. 52. at 9.  To that end, the facility was instructed to consider designating entire units within the facility with designated staff to treat patients with COVID-19 when infection rates are high.  Id.  If an area was designated to care for COVID-19 patients, only residents who have a confirmed COVID-19 infection should be placed in the unit.  Id. at 10.

The policy addressed recommendations for newly identified COVID-19 cases and addressed the high risk of unrecognized infections among residents.  Specifically, the policy states that a single new case of COVID-19 in any staff or resident should be evaluated as a potential outbreak.  CMS Ex. 52 at 14.  To aid in treating the situation as a potential outbreak, staff were instructed to wear N95 or higher respirators, eye protection, gloves and gowns.  Id.  The facility was also instructed to ensure that appropriate PPE is available outside the resident room for any resident who is on isolation unless the resident resides on a dedicated COVID-19 unit.  Id.

If there were suspected or confirmed cases of COVID-19 in the memory care unit, the policy provided additional guidance.  CMS Ex. 52 at 15.  The policy notes that it may be challenging to restrict residents in the memory care unit to their rooms, so the facility should implement the use of eye protection and N95 or other respirators for staff when on

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the unit.  Id.  The policy explained that requiring all staff to wear PPE will help address the potential for encountering a wandering resident who might have COVID-19.  Id.  Lastly, the policy stated that it may be helpful to have dedicated staff working in the memory care unit.  Id.

C.  The facility’s deficiencies.

Failure to place adequate signage.  As noted above, the facility’s policy required the posting of signage at the entrance of the building and in other strategic places to inform visitors and staff of an infection outbreak.  CMS Ex. 52 at 1.

It is undisputed that there were multiple positive COVID-19 residents in the facility, and specifically in the memory care unit, when the inspection began on May 8, 2023.  CMS Ex. 48.  On May 8, 2023, at approximately 9:45 a.m., the surveyor observed that there were no visual alerts posted at the entrance to the Memory Care Unit entrance to inform visitors or staff of an identified infection outbreak.  CMS Ex. 1 at 99.  There was similarly no signage advising of the need to wear PPE before entering the unit.  Id.  Also, once the surveyor entered into the Memory Care Unit, there was no signage on the doors of Residents 42, 45, 60, and 72 to inform staff and visitors of the need to see a nurse prior to entering their rooms or the need to wear PPE.  Id. at 99-100.

At around 10:10 a.m. on May 8, 2023, the surveyor observed staff members placing signs that said “contact precautions” on the doors of multiple residents in the memory care unit.  CMS Ex. 99 at 100-101.  The surveyor also spoke to staff member A who admitted to having removed any signage in the memory care unit earlier that morning because she wasn’t sure who had tested positive for COVID-19 over the weekend.  CMS Ex. 14.

Petitioner argues that the signage posted throughout the facility was both adequate and in the proper locations.  Even assuming arguendo that the signage was properly posted, the signage still failed to instruct staff and visitors about the type of outbreak and the proper PPE required.  The facility’s own policy states that the signage should include instructions about current infection prevention and control recommendations.  CMS Ex.  52 at 6.  The instructions included on the signs for contact precautions only mandate the wearing of gloves and a gown.  CMS Ex. 8 at 5.  The facility’s policies required the use of N-95 masks, eye protection, gowns and gloves when entering a COVID-19 positive resident’s room.  See CMS Ex. 50; CMS Ex. 52.  The signs placed around the facility should have reflected these requirements.  Further, the Regional Director of Life Care’s Clinical Services told the surveyor that she provided different signs with the proper information to the Director of Nursing (DON) on May 4, 2023 (4 days before the survey) but the DON did not use the correct signs.  CMS Ex. 14.  As a result, it is undisputed that the facility did not have proper signs placed throughout their facility including in the memory care unit.

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Failure to implement proper precautions.  At the time of the May 8, 2023 survey, the facility’s policies required the use of N-95 masks, eye protection, gowns and gloves when entering a confirmed or suspected COVID-19 positive resident’s room.  See CMS Ex. 50; CMS Ex. 52.  The facility’s policies were reflective of CDC guidance in place at the time.  The facility’s policy also stated that any employee entering the memory care unit must wear an N-95 or similar respirator mask and eye protection to minimize the risk of spreading COVID-19 when encountering wandering residents.  CMS Ex. 52 at 15.  The policy further laid out guidelines for training staff on the use of PPE and instructed staff to reference CDC guidance for the application and removal of PPE.  Id. at 8.  The CDC guidance in place during the May 8, 2023 survey stated that staff should put on PPE upon entering a room and take PPE off and discard it before exiting a resident’s room.  CMS Ex. 65 at 72-73; CMS Ex. 66.

During the May 8, 2023 survey, the surveyor observed that there were no signs indicating that wearing PPE was necessary upon entering the memory care unit.  CMS Ex. 14 at 11.  There were two bins containing PPE (gowns, gloves, N-95 masks, and face shields) for Residents 42, 45, 60, and 72.  Id.  There was no PPE made available at the entrance to the memory care unit.  Id.  The residents were seen without PPE and staff was seen wearing improper PPE.  Id.  Specifically, the surveyor observed staff wearing N-95 masks and surgical masks without gloves, gowns, or eye protection.  Id.

Petitioner also argues that staff were in compliance with CDC guidelines in place at the time.  P. Br. at 18 (citing P. Ex. 11, 12).  Petitioner does not assert that staff’s PPE usage was in compliance with its own guidelines and the undisputed facts show that staff were seen not wearing proper PPE.

Petitioner further argues that training was provided to staff on the proper use of PPE.  P. Br. at 12; P. Ex. 3.  However, regardless of training, it is undisputed that the staff were not following the facility’s policies and CDC guidance regarding the usage of PPE.

Quarantine delays: residents.  The facility’s policy stated that a patient with a confirmed or suspected COVID-19 infection should be placed in a single-person room with the door kept closed and a dedicated bathroom.  CMS Ex. 52. at 9.  The policy advised that an entire area could be designated as a care unit for COVID-19 patients but if that designation was made, only residents with a COVID-19 confirmed diagnosis could be housed there.  Id. at 9-10.

According to the facility’s COVID-19 reporting for May 8 and 9, 2023, Resident 92 tested positive for COVID-19 on May 5, 2023.  CMS Ex. 41 at 1.  Resident 50 did not test positive for COVID-19 until May 8, 2023.  CMS Ex.  15 at 3-4.  As a result, according to the facility’s own policy, Resident 92 and Resident 50 should have been separated.  Petitioner argues instead that because Resident 92 and Resident 50 were in the same room and likely exposed to COVID-19 by the same person, they did not need to be

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separated.  P. Br. at 19-23.  However, as noted above, the facility’s policy states that those residents with a suspected or confirmed COVID-19 infection should be separated into a single-person room.  And, according to that same policy, if the memory unit had been designated a COVID-19 care unit, only those residents with a confirmed COVID-19 infection should have been housed in the unit.  Petitioner does not argue that Resident 50 had an earlier positive COVID-19 test.  Therefore, it is undisputed that Resident 50 and Resident 92 should have been separated.

Petitioner argues again that it followed CDC guidance when separating residents.  However, Petitioner fails to dispute that it failed to follow its own infection control policies.

2. The facility was not in substantial compliance with 42 C.F.R. § 483.75 because the facility failed to ensure that its quality assurance and performance improvement program (QAPI) developed and implemented appropriate plans of action to investigate, develop, and implement an effective performance improvement plan for the prevention of the possible spread of infection when a COVID-19 outbreak was identified in the facility.
3. The facility was not in substantial compliance with 42 C.F.R. § 483.70 because its failure to follow its infection control policies establish that the facility was not administered to effectively use its resources, and did not adequately address or contain a COVID-19 outbreak.

Program requirement:  42 C.F.R. § 483.75 (Tag F867).  The facility must maintain a quality assessment and assurance committee that reports to the facility’s governing body.  At a minimum, the committee must include:  the DON; the Medical Director or designee; at least three other members, including the administrator, owner, a board member, or other individual in a leadership role; and the infection preventionist.  The committee must meet at least quarterly and as needed to coordinate and evaluate activities under the facility’s QAPI program.  Among other duties, it must identify issues “with respect to which quality assessment and assurance activities . . . are necessary.”  The committee must “develop and implement appropriate plans of action to correct identified quality deficiencies.”

Program requirement:  42 C.F.R. § 483.70 (Tag F835).  The facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

Facility policy:  QAPI.  Consistent with the regulation, the facility had in place a policy requiring it to develop a QAPI program setting forth the process for conducting QAPI

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activities, such as identifying and correcting quality deficiencies as well as opportunities for improvement.  CMS Ex. 55 at 1.  The facility’s policy directed that the QAPI plan should include processes for identifying and prioritizing quality deficiencies and developing and implementing corrective action or performance improvement activities.  Id. at 2.  The policy also called for performance improvement that includes the continuous study and improvement of processes with the goal of improving care delivery and enhancing resident quality of life.  Id. at 3.  Importantly, the facility’s QAPI policy also called for the facility’s governing body to develop and implement appropriate plans of action to correct identified quality deficiencies.  Id. at 4.

Facility disregard of QAPI requirements.  The facility was not in substantial compliance with 42 C.F.R. § 483.75 because the facility management did not implement an effective QAPI program, for which the governing body is accountable, and no evidence establishes that the governing body met and responded to quality deficiencies throughout the facility.

Substantial noncompliance under section 483.70 can be based on other deficiency findings.  As discussed below, I find that the facility’s deficiencies posed immediate jeopardy to resident health and safety, which, by itself, justifies the finding that the facility was not in substantial compliance with 42 C.F.R. § 483.70.  It is settled that a finding of substantial noncompliance in the facility’s administration may derive from findings of substantial noncompliance in other areas.

[W]here a facility has been shown to be so out of compliance with program requirements that its residents have been placed in immediate jeopardy, the facility was not administered in a manner that used its resources effectively to attain the highest practicable physical, mental, and psychosocial well-being of each resident.

Asbury Ctr. at Johnson City, DAB No. 1815 at 11; Lopatcong Ctr., DAB No. 2443 at 13 (2012) (reiterating the Board’s long-standing determination that where a deficiency finding under section [then 483.75, now 483.70] derives from other findings, “i.e., was based on the surveyors’ identification of other deficient practices,” those separately identified deficiencies “may constitute a prima facie case that a facility has not been administered efficiently or effectively as required by section 483.75.”) (quoting Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 at 7 (2002)); see also Stone Cnty. Nursing and Rehab. Ctr., DAB No. 2276 at 15-16 (2009).

Administrative failings.  Although I may find substantial noncompliance with section 483.70 based solely on the facility’s other deficiencies, many of the facility’s failures were directly attributable to its administration, which was, after all, ultimately responsible for the facility’s response to the Covid outbreak.

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Moreover, the facility’s administrator and its medical director were remarkably ill-informed of their responsibilities.  These breakdowns are evidenced by the fact that Director of Nursing was suspended for failure to follow the clinical policies related to infection control.  CMS Ex. 14 at 18.  The Medical Director was not informed about a COVID-19 outbreak and was not included in quality assurance meetings.  CMS Ex. 14 at 15-16.  The facility’s administrator stated that she was unaware that incorrect signage had been posted and that staff was not wearing appropriate PPE.  CMS Ex. 14 at 16-17.  Further, when the surveyors requested a copy of the QAPI records related to COVID-19 outbreak, they were provided with a single document completed by the Regional Director of Clinical Services.  CMS Ex. 64; CMS Ex. 71.  Despite the admitted failings, the Regional Director of Clinical Services acknowledged the problems the facility had with implementing its infection control policy but insisted that a root cause analysis or performance improvement plan were unnecessary.  CMS Ex. 14 at 17.

Further, as set forth above, the facility failed to implement a QAPI program that complied with regulatory requirements and the facility’s own policy.  For this failing, the governing body is accountable.

Petitioner argues that the Medical Director was aware of the outbreak but does not provide his testimony or other statement.  In sum, it is clear that the undisputed evidence discussed throughout this decision supports a finding that the facility was not compliant with the QAPI and the administration requirements.

4. The facility was not in substantial compliance with 42 C.F.R. §§ 483.12 and 483.25 because it did not provide its residents with the goods and services they needed to avoid suffering physical harm, pain, mental anguish, and emotional distress and to attain or maintain the highest practicable physical, mental, and psychosocial well-being.

Program requirement:  42 C.F.R. § 483.12 (tag F600).  A facility resident has the right to be free from abuse, neglect, and exploitation.  42 C.F.R. § 483.12.  “Neglect” is defined as the failure of the facility, its employees, or service providers to provide a resident with the goods and services necessary to avoid his/her suffering physical harm, pain, mental anguish, or emotional distress.  42 C.F.R. §§ 483.5, 488.301.

Facility Policy: Neglect.  The facility’s policy on abuse and neglect states that the facility must ensure that residents are free from neglect and that the facility must have processes in place to provide needed care and services to all residents.  CMS Ex. 54 at 1.  The policy states that neglect includes cases where indifference for resident care or safety resulted in or had the potential to result in physical harm or pain.  Id. at 6.  The policy also states that neglect includes incidents where a resident’s needs are unmet because of staff’s lack of knowledge.  Id.

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Failure to keep residents free from neglect: As the discussions above outline, the facility’s failure to post proper signage about COVID-19, failure to properly cohort residents, and failure to follow its infection prevention policies amounted to neglect to the residents.  The residents undisputably suffered physical harm when they contracted COVID-19 as a result of the facility’s failures.

5. The undisputed evidence establishes that CMS’s determination that the facility’s deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy.  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. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

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.  Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing & Rehab Ctr. – 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 harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.’”  Maysville Nursing and Rehab., DAB No. 2874 at 21 (2018) (quoting Libertywood Nursing Ctr., DAB No. 2433 at 18 (2011), aff’d, Libertywood Nursing Ctr. v. Sebelius, 512 Fed. App’x 285 (4th Cir. 2013)).

With respect to the standard for determining whether immediate jeopardy exists, I need not find that the facility’s noncompliance caused actual harm or injury to a resident.  So long as the deficiencies are likely to cause serious injury or harm, they pose immediate jeopardy.  42 C.F.R. § 488.301.

Petitioner argues that CDC guidelines were changing and that the facility was compliant with the CDC’s guidance.  P. Br. at 5-6.  However, the deficiencies cited in this case were a result of the facility’s failure to follow its own policies.  At a minimum, facilities were

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required to follow the basic infection control guidelines that were incorporated into its written policies.

Further, failing to follow infection control policies during the outbreak of an infectious disease is likely to cause serious harm to facility residents.  In Golden Living Ctr. – Superior, for example, the Board concluded that it was not erroneous for CMS to determine that the facility’s failure to implement – fully and promptly – influenza control precautions posed immediate jeopardy to resident health and safety.  DAB No. 2768 at 25-26.  There, the facility had failed to implement the infection control protocols specifically designed and intended to contain an outbreak of influenza, a contagious virus known to cause substantial illness and even death to many long-term-care residents.  The Board observed that the facility’s own experience established that the likelihood of serious harm to residents from the spread of the disease was neither hypothetical nor insubstantial.  Five residents contracted the disease within a two-week period.  Id.  Here, the facility’s experience even more dramatically establishes that the “likelihood of serious harm to residents from the spread of the disease was neither hypothetical nor insubstantial.”  Id. at 25.

Because COVID-19 is so infectious (see, CMS Exs. 69, 70) and because nursing home residents are so vulnerable, keeping the virus out of the facility was critically important.  For that reason, the facility’s policies mandated that proper signage be posted, residents were timely separated, and proper PPE was used.  Yet despite developing these policies, the facility failed to implement them fully.  The facility also did not timely administer improvement plans or make other changes consistent with QAPI policies to try to slow a potential outbreak and determine what went wrong.  Because of this failure, COVID-19 spread in the facility.

Because the facility’s deficiencies were likely to cause serious harm, CMS’s determination that those deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.

6. The penalties imposed – $13,695 per day for the period of immediate jeopardy and $360 per day for the period of substantial noncompliance that did not pose immediate jeopardy – are 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

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(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 Rehab., DAB No. 2738 at 20 (2016).

Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, July 20, 2023.  Here, CMS imposed penalties of $13,695 per day for the initial period of immediate jeopardy.  The amount is in the lower range for situations of immediate jeopardy ($7,317 to $23,989).  CMS imposed a penalty of $360 per day for the period of substantial noncompliance that did not pose immediate jeopardy, which is at the very low end of the range ($120 to $7,195).  42 C.F.R. §§ 488.408(e), 488.438; 45 C.F.R. § 102.3; 87 Fed. Reg. 15100 (March 17, 2022).

Considering the relevant factors, these amounts are reasonable.

Petitioner argues generally that the CMP is not reasonable but does not claim that it is unable to pay the penalty.

With respect to the remaining factors, I have discussed in detail the facility’s widespread deficiencies and its disregard for its own written policies.  The facility failed to follow basic infection control protocols and that lapses in implementing its infection control policies put its residents in immediate jeopardy during the COVID-19 outbreak.  For this, the facility is culpable, and the penalty is reasonable.

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Conclusion

From May 4, 2023 through June 23, 2023, the facility was not in substantial compliance with Medicare program requirements, and, from May 4, 2023 through May 11, 2023, its deficiencies posed immediate jeopardy to resident health and safety.

The penalties imposed are reasonable.