Sligo Creek Center, DAB No. 3191 (2025)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Sligo Creek Center (Petitioner), a Maryland skilled nursing facility (SNF), requests review of the October 23, 2020 Administrative Law Judge (ALJ) decision, Sligo Creek Center, DAB CR5745 (2020) (ALJ Decision). The issue before the ALJ was whether Petitioner was in substantial compliance with the requirement to adopt and implement infection control policies in 42 C.F.R. § 483.65, from June 14, 2016 through December 11, 2016. The ALJ concluded that: (i) Petitioner was not in substantial compliance with section 483.65 as alleged by the Centers for Medicare and Medicaid Services (CMS); (ii) CMS’s determination that Petitioner’s noncompliance with section 483.65 posed immediate jeopardy to resident health and safety from June 14 through October 5, 2016 was not clearly erroneous; and (iii) the $12,541 per-day civil money penalty (CMP) that CMS imposed against Petitioner for the period of immediate jeopardy was reasonable.¹ For the reasons discussed below, we affirm the ALJ Decision.

Legal Background

A. Social Security Act and Medicare Regulations

To participate in the Medicare program, a SNF must be in “substantial compliance” with the participation requirements in 42 C.F.R. Part 483, subpart B. 42 C.F.R. §§ 483.1(b), 488.400. Substantial compliance requires a level of compliance “such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” Id. § 488.301. The term “noncompliance,” as used in the applicable

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regulations, is synonymous with lack of substantial compliance. Id. The participation requirements at issue in this appeal include the requirement to establish and maintain an infection control program found at 42 C.F.R. § 483.65,² which required:

The facility must establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of disease and infection.

(a) Infection control program. The facility must establish an infection control program under which it—

(1) Investigates, controls, and prevents infections in the facility;

(2) Decides what procedures, such as isolation, should be applied to an individual resident; and

(3) Maintains a record of incidents and corrective actions related to infections.

(b) Preventing spread of infection.

(1) When the infection control program determines that a resident needs isolation to prevent the spread of infection, the facility must isolate the resident.

(2) 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.

(3) The facility must require staff to wash their hands after each direct resident contact for which handwashing is indicated by accepted professional practice.

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Compliance with Medicare participation requirements is verified through onsite surveys performed by state survey agencies. Id. §§ 488.10(a), 488.11. A state survey agency reports any “deficiency” (failure to meet a participation requirement) it finds in a Statement of Deficiencies (SOD) that organizes deficiency findings by alpha-numeric “Tags” corresponding to regulatory requirements and CMS guidance.³ See id. § 488.110(i), (m); Vibra Hospital of Charleston-TCU, DAB No. 3094, at 2 n.2 (2023); see generally CMS Pub. 100-07, State Operations Manual (SOM), Chapter 7, Survey and Enforcement Process for Skilled Nursing Facilities & Nursing Facilities; Cross Creek Health Care Ctr., DAB No. 1665, at 7 (1998) (explaining that the SOM “is distributed to state survey agencies to assist them in conducting facility surveys”). A SOD also indicates the survey agency’s assessment of the “seriousness” (addressing the scope and severity) of any cited deficiency. Id. §§ 488.404(a)-(b). The most serious noncompliance poses immediate jeopardy, meaning it “has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” Id. § 488.301 (defining “immediate jeopardy”).

CMS may impose one or more enforcement “remedies” on a SNF found to be out of substantial compliance. Act § 1819(h); 42 C.F.R. §§ 488.400; 488.402(b)-(c); 488.404; 488.406; 488.408(a)-(e). Available remedies include a CMP, assessed either per day or per incident. 42 C.F.R. §§ 488.406(a)(3); 488.430. When CMS assessed the remedy here, daily CMPs could range from $6,291 to $20,628 per day for noncompliance posing immediate jeopardy, and from $103 to $6,188 per day for less serious noncompliance.⁴ Id. §§ 488.408(d)(1)(iii), (e)(1)(iii); 488.438(a)(1)(i)-(ii). Within either range, CMS sets an amount by considering specified factors. Id. §§ 488.404; 488.408(b), (d)(2), (e)(2); 488.438(b), (f). A per-day CMP may accrue “as early as the date that the facility was first out of compliance” and continues until it achieves substantial compliance, or its provider agreement terminates. Id. §§ 488.440(a)(1), 488.454(a).

A SNF may appeal a determination of noncompliance that led to the imposition of a remedy by requesting an ALJ hearing and appealing any unfavorable ALJ decision to the Board. 42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(b)-(c). However, certain issues are not appealable, including CMS’s choice of remedy and CMS’s noncompliance level determination (unless it would affect the applicable CMP range). Id. §§ 488.408(g)(2); 498.3(b)(13)-(14); see also Meridian Nursing Center, DAB No. 2265, at 13, 16 (2009),

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aff’d Fal-Meridian, Inc. v. U.S. Dep`t of Health & Human Servs.,604 F.3d 445 (7th Cir. 2010) (citing Ridge Terrace, DAB No. 1834, at 7 (2002)).

B. U.S. Centers for Disease Control and Prevention (CDC) Guidelines⁵

Tuberculosis (TB) is an infectious disease that is caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis). M. tuberculosis is carried in airborne droplets and is spread by people who have pulmonary or laryngeal TB when they cough, sneeze, shout, or sing. TB is not normally spread by surface contact. However, M. tuberculosis can remain airborne on normal air currents in a building for a prolonged period and can spread throughout a room or building. Infection occurs usually within two to 12 weeks when a person inhales the droplet with M. tuberculosis, at which point an individual tests positive when tested for TB. See CMS Ex. 41, at 6, 115-16; CMS Ex. 42, at 2-3; CMS Ex. 53, at 9.

Latent TB infection (LTBI) is a condition in which a person is infected with M. tuberculosis but does not have active TB. People with LTBI are asymptomatic, do not feel sick, have a positive skin test but a negative chest x-ray (CXR) for TB, and do not transmit the disease. A person infected with LTBI is at risk for progressing to TB. Treatment (referred to as preventative therapy, chemoprophylaxis, or prophylaxis) is indicated for those at risk for progression to active TB. See CMS Ex. 41, at 46; CMS Ex. 53, at 4; see also CMS Ex. 49, at 126-29. For most persons, the only evidence of LTBI is an immune response against mycobacterial antigens demonstrated by a positive skin test or a blood antigen assay such as QuantiFERON^®-TB Gold test (QFT-G).⁶ CMS Ex. 53, at 12. Once a person has contracted LTBI, the risk for progression to active TB varies. The greatest risk for progression to disease occurs within the first 2 years after infection. Id.

TB and infectious TB mean that the disease caused by M. tuberculosis is clinically active and patients are generally symptomatic. See CMS Ex. 53, at 4. Infectious TB refers to active TB of the lungs or larynx. People with infectious TB have the potential to transmit the disease. Id. This decision will use the terms “LTBI” and “active TB.”

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CDC guidance further provides:

• Residents and staff of congregate settings such as long-term care facilities are among those at highest risk for exposure and infection. CMS Ex. 41, at 7.
• Treatment of LTBI is essential to control and eliminate TB because it substantially reduces the risk that M. tuberculosis will progress to active TB. Id. at 55.
• Persons at high risk for progression from LTBI to active TB include people infected with M. tuberculosis within the previous two years. Id. at 7.
• Approximately five percent of people with newly acquired LTBI progress to active TB within two years if there is no intervention. CMS Ex. 53, at 37.
• Approximately five to 10 percent of people with LTBI who are not treated will develop active TB during their lifetime. CMS Ex. 30, at 7; CMS Ex. 41, at 6.
• Health care facilities pose an increased risk for transmission of TB due to the congregate setting. CMS Ex. 30, at 9; CMS Ex. 41, at 7, 29; CMS Ex. 53, at 17.
• Elderly residents in SNFs and nursing facilities (NFs) “are almost twice as likely to acquire TB as those living in the community,” accordingly the CDC recommends that nursing home residents with LTBI “should be offered treatment according to current recommendations.” CMS Ex. 53, at 60.
• Control of TB in nursing homes requires, among other things, prompt detection and diagnosis, isolation of those who are infectious, and initiating standard therapy; there is evidence of the value in treating LTBI in elderly residents of nursing homes to prevent future outbreaks and that treatment of LTBI can reduce the risk for death due to progression to active TB. CMS Ex. 32, at 5-6; CMS Ex. 33, at 6; CMS Ex. 41, at 86; CMS Ex. 53, at 60, 70.
• CDC recommended strategies for controlling TB in the United States include identification of people with LTBI that are at risk for progression to active TB and treatment with an effective drug regimen. CMS Ex. 30, at 16; CMS Ex. 53, at 17.
• The preferred treatment for LTBI is nine months of isoniazid (INH), but other treatment regimens are characterized as acceptable alternatives. CMS Ex. 30, at 18; CMS Ex. 41, at 55, 86.
• The responsibility for TB control and prevention in the United States rests upon public health officials, including federal, state, county, and local public health agencies. CMS Ex. 53, at 22.
• The primary responsibility for ensuring the quality and completeness of all TB-related services rests with the jurisdictional health agency. CMS Ex. 53, at 25; P. Ex. 4, at 2, 7; P. Ex. 5, at 1-2.

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C. Maryland Regulations and Guidelines

The Code of Maryland Regulations (COMAR) in effect at the time of the survey addressed a number of processes involving SNFs, including Medical Director Duties and TB control, and identified actions for both health care providers and health officers.⁷ See COMAR, Department of Health, Diseases, Communicable Diseases and Related Conditions of Public Health Importance § 10.06.01 (2017); Department of Health, Hospitals, Comprehensive Care Facilities and Extended Care Facilities, Medical Director Duties § 10.07.02.11-1 (2017), and Infection Control Program (ICP) § 10.07.02.21 (2017). These regulations incorporate CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities (Morbidity and Mortality Weekly Report (MMWR) 1994; Vol. 43/No. RR-13).⁸ COMAR § 10.07.02.01-1(B)(1).

A health officer is required to recommend appropriate treatment for LTBI for contacts of communicable TB as well as provide for supervised treatment of LTBI for children under four (4). Id. § 10.06.01.21(B)(2)-(3); see CMS Ex. 38, at 19. A facility Medical Director is responsible for overall coordination, execution, and monitoring of physician services, and shall perform other essential duties related to clinical care and physician practices, including serving as a liaison with local health officials and public health agencies that have policies and programs that may affect the facility’s care and services to residents. Id. § 10.07.02.11-1(A)(1), (G)(3); see CMS Ex. 38, at 13-14. A SNF is required to develop written policies, consistent with COMAR, to govern the nursing care and related medical or other services it provides, including Infection Control and TB surveillance. Id. § 10.07.02.09(A)(15)-(16); see CMS Ex. 38, at 7. A facility’s ICP shall include monitoring of the health status of all residents to determine if the residents are free from communicable TB. Id. § 10.07.02.21-2(A). Additionally, a facility shall assess residents for TB according to CDC Guidelines, perform a yearly symptom review and assess and manage a resident with a history of previous positive TB skin test, previous history of active TB, or positive skin test conversion⁹ in accordance with CDC Guidelines. Id. § 10.07.02.21-2(B)(1), (4)-(5).

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The Maryland Department of Health and Mental Hygiene issued Guidelines for Prevention and Treatment of TB in 2007. CMS Ex. 39. These Guidelines reference the 2005 version of the CDC Guidelines For Preventing The Transmission of Mycobacterium tuberculosis In Health-Care Settings, 2005. MMWR 2005; Vol. 54/No. RR-17. See CMS Ex. 39, at 8, 45. These Guidelines address the roles of both the local health departments and providers, and state that limited public health resources should be allocated and prioritized, and list activities in descending priority order, with three levels. Id. at 10. Treatment of LTBI is listed in both the second and third level, depending on the individual’s risk. Id. at 11-12 (Table 4). The Maryland Guidelines also include:

• It is the responsibility of the local health department to identify, evaluate promptly, and ensure an appropriate course of treatment is prescribed and completed for all people suspected of having active TB. Id. at 10.
• A private provider undertaking to treat one with active TB is undertaking a public health function that includes prescribing an appropriate treatment regime and ensuring adherence to that regime until treatment is completed. Id.
• A decision to test is a decision to treat, including recent contacts exposed to TB infection and residents of SNFs/nursing facilities (NFs). Id. at 12-14.
• Treatment should be targeted to high-risk groups regardless of age, including the recently infected and those in SNFs/NFs. Id. at 19.
• The purpose of treating LTBI is to reduce the chance an individual with LTBI progresses to active TB. Id.
• Individuals found to have a positive skin test should be examined by a provider to rule out active TB disease and be evaluated for treatment of LTBI. The evaluation consists of TB symptom review, CXR, and testing and evaluation of other medical conditions. Id.
• Either INH or rifampin is used for treatment of LTBI. Id. at 20-21.

Case Background¹⁰

Petitioner operates a long-term care facility in Takoma Park, Maryland that participates in Medicare as a SNF. The factual basis of this appeal is nearly undisputed and involves the occurrence of active TB and LTBI, involving both staff members and residents, in Petitioner’s facility in 2015 and 2016.

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A. Petitioner’s written policy concerning TB Management

Petitioner’s written infection control policy (ICP) included policies and procedures specific to TB Management. P. Ex. 6.¹¹ The policy’s stated purpose was “[t]o reduce the risk for [TB] among patients” and “[t]o provide appropriate management post exposure.” Id. at 1. The practice standards for screening indicated that all residents are tested upon admission. Id. ¶ 1.1. The standards for post exposure indicated that when TB is identified, “notify the state Health Department and follow its recommendations for investigation and follow-up”; “[i]nvestigate to identify if any patients or employees have been exposed”; and “[f]ollow Tuberculosis Post Exposure procedure to determine treatment needed for patients.” Id. ¶¶ 2.1-2.2.1 (emphasis omitted).

The TB screening procedures specify initial testing frequency and what to do if both the first and second tests are negative (no further evaluation is needed); or positive (obtain a CXR and medical evaluation); and observe for signs and symptoms of TB (if any present, initiate medical evaluation). Id. ¶¶ 2–2.3. These procedures also specify the process for residents with a particular history, including a written history of a positive skin test, residents who have a history of the BCG vaccination, residents with necrotic or anaphylactic response to the skin test, and those who refuse the skin test. Id. ¶¶ 3.1-3.4. Finally, it addresses screening documentation. Id. ¶ 5.

The post-exposure procedures for residents specify what to do as soon as TB exposure is identified and how to handle residents with and without a written history of a positive skin test. See id. ¶¶ 1–4. In either case, obtaining a CXR and medical evaluation is required, and if negative for active disease, the resident is to be medically evaluated for prophylaxis. Id. ¶¶ 3.5, 4.1.2. Finally, the post exposure procedures address documentation, indicating that skin test administration and results are documented in the Medication Administration Record (MAR) or PCC [“PointClickCare” electronic record system implemented by Genesis], and interventions and follow-ups such as a CXR, are documented in nurse’s notes. Id. ¶¶ 5.1–5.2.

B. TB Incidents in 2015 and 2016

In 2015, two of Petitioner’s staff members were diagnosed with active TB by the Montgomery County, Maryland Department of Health and Human Services (hereinafter the county) on different dates. On or about March 10, 2015, the county initially notified Petitioner that staff member #1, who worked in the laundry, “is under my care and is notcleared to return to work.” ALJ Decision at 14; P. Ex. 1 (emphasis added). The initial

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letter did not reveal that staff member #1 had active TB, but Petitioner learned of the diagnosis approximately two months later from the employee’s leave paperwork indicating the employee had active TB. Id.; see also CMS Ex. 14, at 36. The case of staff member #1 is referred to as an “index case” by the parties and their respective expert witnesses. ALJ Decision at 14. On April 27, 2015, Petitioner learned staff member #2 was being treated for active TB and had been hospitalized from April 8–21, 2015, again from leave paperwork submitted by the employee.¹² CMS Ex. 14, at 37. On May 7, 2015, the county reached out to Petitioner’s infection control nurse (ICRN), requesting that the facility provide the “housekeeping/laundry” staff members with the number for the county to “make an appointment with them for assessment.” Id. at 36.

While some details are not fully developed in the record, on May 13, 2015, the county communicated to Petitioner that staff members #1 and #2 had been diagnosed with active TB and that a former resident who had been hospitalized in March of 2015 and subsequently passed away in April of 2015 (while still hospitalized), was found to have active TB at the time of death. See CMS Ex. 13, at 14; ALJ Decision at 14 (citing Tr. at 987-92); Petitioner’s Proposed Finding of Fact (PPFF) ¶ 78; CMS Proposed Findings of Fact (CPFF) ¶ 21. The county Nurse Administrator for TB control contacted Petitioner’s facility administrator to set up a meeting to discuss TB contact investigation and response to the situation. CMS Ex. 44, ¶ 2; Tr. at 466, 986. That meeting took place on May 15, 2015, and both the county Nurse Administrator and the county Case Manager visited Petitioner and met with its staff to provide guidance regarding the TB contact investigation process. CMS Ex. 14, at 40-41, 45; CMS Ex. 44, ¶ 2; see also P. Ex. 7 (list of meeting attendees).

The primary purpose of the county’s meeting with Petitioner’s staff was “to provide direction . . . about how to perform the contact investigation for staff and residents following active [TB] exposure.” CMS Ex. 44 ¶ 2. County personnel explained to staff that the SNF was at high risk for TB transmission because it is a congregate setting, and further indicated that because Petitioner’s staff were responsible for the direct care and treatment of its residents, Petitioner’s staff would be responsible for testing its residents for TB and for follow up treatment. Id. at ¶¶ 2-3. County personnel testified that during that meeting they reviewed general guidance regarding prophylactic treatment to individuals with LTBI, informed Petitioner it was responsible for providing prophylactic treatment, and recommended that anyone with a positive skin test or QFT-G test, and active TB ruled out, receive prophylactic treatment unless contraindicated. See Tr. at 486-491, 569-570, 575. Petitioner’s staff indicated they would handle all the TB skin testing of residents and requested assistance from the county for residents for whom a

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QFT-G blood test was recommended.¹³ Id. Generally, the contact investigation involves a series of two skin tests, eight weeks apart, for anyone who has not already had a positive skin test (all residents are tested on admission to the SNF). Anyone with a positive skin test or positive QFT-G test would then receive a CXR to rule out active TB. Tr. at 565-569.

Over the ensuing weeks, the first round of skin testing was done for Petitioner’s staff and residents, and CXRs were taken as needed. Again, the details are somewhat imprecise, but at least 19 residents had positive skin tests and negative CXRs.¹⁴ See P. Exs. 9, 11, 13; see also ALJ Decision at 15 n.13. No residents were found to have active TB. Id. Petitioner’s ICRN and the county staff agreed to hold off with any LTBI prophylactic treatment until after the second round of testing. See ALJ Decision at 15 (citing Tr. at 585–87, 633–34, 1065; PPFF ¶ 111; CPFF ¶ 32). In August 2015, the second round of skin testing was initiated for all residents with negative results in the first round. Out of 40 residents tested, six had positive results, but all had negative CXRs. P. Ex. 15. Additionally, a few residents with positive skin tests and negative CXRs in round one had passed away, been discharged, or transferred out of the facility before the second round of testing. See P. Ex. 15, at 14; CMS Ex. 28, at 2. The county had drawn blood for QFT-G testing for some, but not all, of the residents who required it. P. Ex. 15, at 13–14.

One resident, R4, being evaluated for a possible kidney transplant, tested positive on the skin test and QFT-G during round one of the 2015 testing. P. Ex. 11, at 3; P. Ex. 20, at 1; CMS Ex. 8, at 36–37. On September 17, 2015, Petitioner’s ICRN texted the county Case Manager, inquiring about treatment advice for dialysis patients. P. Ex. 18, at 1. The Case Manager’s response indicated “we have no dr right now. i will have to check with dr Walsh when he comes next week to read X-rays.” Id. at 2. In October of 2015, while undergoing testing for the kidney transplant, R4’s bloodwork again tested positive for LTBI. P. Ex. 20, at 2; see also Tr. at 1060. The transplant evaluation physician prescribed INH and Vitamin B6 (prophylactic treatment).¹⁵ P. Ex. 20, at 1–2. On November 5, 2015, Petitioner’s ICRN again texted the county Case Manager, indicating a

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fax with the updates on the dialysis patient would be forthcoming, and asked again about scheduling the last few residents for QFT-G blood draws. P. Ex. 18, at 4; P Ex. 20, at 1. The county Case Manager responded that perhaps the blood draws could be done the following week since it required coordination with lab personnel, and asked if “[Petitioner’s Medical Director] put residents on prophy?” P. Ex. 18, at 4. The ICRN replied that Petitioner had a new medical director and “[n]othing has been started with the residents. We will need to coordinate process.” Id. at 4-5. The county Case Manager replied that she too had a new medical director and “maybe we can meet one afternoon and figure out a plan.” Id. The last communication in the record between the ICRN and county Case Manager is another text sent by the ICRN, over two months later, on January 26, 2016, “[w]ondering what the plans are for Sligo” and indicating that staff member #2 had stopped by the facility but only got as far as the front lobby. Id. at 6. The Case Manager replied, “plan to meet with you soon to see where we are.” Id. at 7.

TB testing and the administration of prophylactic medication for LTBI was regularly discussed among Petitioner’s staff and management at the Quality Assurance (QA) meetings from August 2015 through January 2016. ALJ Decision at 16 (citing PPFF ¶¶ 125, 128–29; CPFF ¶¶ 43-47). Petitioner’s Administrator testified that the QA Committee continued to discuss the matter after January 2016, but acknowledged that the Committee Minutes did not include this topic. PPFF ¶ 130; CPFF ¶ 48. In May 2016, Petitioner’s staff did an annual assessment of residents who had previously tested positive for exposure to TB in 2015 and found no one exhibited signs or symptoms of active TB. ALJ Decision at 16 (citing PPFF ¶ 130; P. Ex. 21).

On June 4, 2016, R1 informed a member of the nursing staff of coughing with chest pain. P. Ex. 10, at 1. R1 had tested positive on the skin test during round one of TB testing in 2015 and previously had a negative CXR, but no prophylactic treatment. CMS Ex. 5, at 29–30, 36; Tr. at 1025–1026. R1’s attending physician ordered a CXR, which showed modest left lower lobe and right upper lobe patchy infiltrates. CMS Ex. 5, at 17. The attending physician diagnosed R1 with bronchitis and prescribed antibiotics, nebulizer treatments and cough medicine. Id. at 2. On August 8, 2016, R1 was coughing up blood and was transferred to a hospital. Id. Nothing in the record indicates that anyone at Petitioner’s facility identified this as a possible symptom of active TB. At the hospital, R1 tested positive for active TB. See PPFF ¶ 183; CPFF ¶ 55; see also CMS Ex. 1, at 18. R1’s diagnosis resulted in Petitioner and the county again testing all residents for TB. See P. Ex. 14; ALJ Decision at 17. The 2016 testing revealed no cases of active TB, but 23 residents were found to have LTBI, 17 of whom were identified in the 2015 testing. The county medical director prescribed prophylactic treatment (INH and Vitamin B-6). See P. Ex. 27; see also Tr. at 1069–70. There is no dispute among the parties that the only resident identified in 2015 as having LTBI who received prophylactic treatment before September of 2016 was R4, which the county played no role in. ALJ Decision at 16 (citing PPFF ¶¶ 132, 134-135, 137, 139, 158; CPFF ¶ 40–41).

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C. 2016 complaint survey and the CMP

On September 27, 28 and October 6, 2016, the Maryland Department of Health and Mental Hygiene, Office of Health Care Quality (state agency) conducted an on-site “complaint survey” of Petitioner’s facility.¹⁶ CMS Ex. 1; CMS Ex. 19, at 1. A “complaint survey” is a survey “conducted on the basis of a substantial allegation of noncompliance.” 42 C.F.R. § 488.705. A “substantial allegation of noncompliance” is defined as “a complaint from any of a variety of sources (such as patient, relative, or third party), . . . that would, if found to be present, adversely affect the health and safety of patients or residents and raises doubts as to a provider’s or supplier’s compliance with any Medicare condition of participation, condition for coverage, condition for certification, or requirements.” Id. § 488.1. Additional survey activities involved interviews of county staff. See CMS Ex. 1, at 12–13, 19. On December 12, 2016, the state agency conducted a revisit survey and found the facility was in substantial compliance but identified deficiencies that posed no actual harm with potential for minimal harm. See CMS Ex. 19, at 35–44.

The initial 2016 survey resulted in citations for multiple deficiencies, only one of which is the subject of this appeal, the violation of section 483.65, which states (in part) that a SNF “must establish and maintain an infection control program designed to provide a safe, sanitary and comfortable environment and to help prevent the development and transmission of disease and infection.” CMS Ex. 1, at 5–15. The basis for that deficiency citation was a finding that Petitioner had failed to “ensure timely follow up of the treatment and management of multiple residents who were identified at risk for exposure to a serious infectious disease [TB] [and] . . . failed to record in residents’ clinical records the rationale for treatment/non treatment for the potential exposure to [TB].” Id. at 7. The survey further found that Petitioner’s violation of section 483.65 had placed residents in immediate jeopardy.

There was no date listed for when immediate jeopardy level noncompliance began, but removal of the conditions that posed immediate jeopardy was confirmed by the resurvey on October 6, 2016. Id. at 7–8; see also CMS Ex. 19, at 1. On October 19, 2016, the state agency informed Petitioner that an immediate per-instance CMP of $8,000 was imposed by the state agency for the deficiency alleging noncompliance with section 483.65. CMS. Ex. 19, at 2. Additionally, Petitioner was informed of the opportunity to request a hearing on the decision to impose the CMP or to pursue Informal Dispute Resolution (IDR) at the state level in accordance with section 488.331. Id. at 3-4. Finally, the state agency indicated that it would recommend CMS terminate Petitioner’s provider agreement on April 6, 2017, if substantial compliance was not achieved by that

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time, and further indicated that if substantial compliance was not achieved by January 6, 2017, CMS would be required to deny payments for new admissions (DPNA). Id. at 2.

On October 28, 2016, in accordance with the state agency’s guidance, Petitioner requested IDR for the cited deficiency alleging noncompliance with section 483.65, including the scope and severity of the deficiency. CMS Ex. 14. On December 13, 2016, the IDR results, which upheld the deficiency but modified the text of the citation, were

provided to Petitioner. CMS Ex. 36, at 1, 16.¹⁷ On January 31, 2017, CMS concurred with the state agency’s survey findings, determined the immediate jeopardy began on June 14, 2016, and imposed a $12,541 per-day CMP for the immediate-jeopardy period (June 14 through October 5, 2016) and a $330 per-day CMP for the remaining period of noncompliance (October 6 through December 11, 2016). CMS Ex. 20, at 1–5.

D. Proceedings before the ALJ

On March 20, 2017, Petitioner timely requested an ALJ hearing, contesting only the finding of “immediate jeopardy” noncompliance of section 483.65, and the associated remedies CMS imposed as a result of that finding. Req. for Hrg. (RFH) at 2.¹⁸

The evidence offered by the parties in this case was voluminous; including excerpts from eight residents’ clinical records; Petitioner’s TB Management policy; memoranda from Petitioner’s Director of Nursing (DON), ICRN, and a “statement” from the prior medical director documented in the form of a memo by the Genesis Sr. VP of Medical Affairs; documents from both the 2015 and 2016 contact investigations; information regarding the QA Committee meetings; communications between members of Petitioner’s staff and the county; excerpts from various CDC and Maryland TB Guidelines and COMAR; survey and post-survey CMP documents and enforcement history; excerpts from CMS Pub. 100-07, State Operations Manual (SOM) (requested by the ALJ); and curricula vitae (CVs), reports, and declarations from expert witnesses for each party offered as written direct testimony. CMS also offered declarations from the surveyor, the county Nurse Administrator, and deposition testimony from its expert witness.

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The parties stipulated to the following facts:

• Petitioner is a SNF located in Takoma Park, Maryland and, at the time of the pertinent events at issue here, participated in the Medicare and Medicaid programs.
• On October 6, 2016, the state agency conducted a survey at Petitioner’s facility, following which it cited certain deficiencies, including one deficiency at 42 C.F.R. § 483.65 (infection control) at scope and severity of “K,” based on the survey team’s finding of a pattern of deficient practice. As a result of the survey findings, the survey team called “immediate jeopardy” on October 6, 2016 at 6:10 P.M. based on the infection control deficiency. The Immediate Jeopardy was abated the same day at 10:30 P.M.
• The state agency sent Petitioner a copy of a SOD from the October 6, 2016 survey (CMS Exhibit 1).
• CMS concurred with the state agency survey findings and the determination of Immediate Jeopardy. As a result, on January 31, 2017, CMS sent Petitioner a Notice regarding the findings of the October 6, 2016 survey (CMS Notice). CMS Ex. 20, at 1.
• CMS imposed a “per diem” CMP in the amount of $12,541 per day for the 114 days beginning June 14, 2016, through October 5, 2016 ($1,429,674); and a per-diem CMP in the amount of $303 for the 67 days beginning October 6, 2016, through December 12, 2016¹⁹ ($20,301), a total of $1,449,975.
• CMS did not impose a DPNA or provider agreement termination action.
• CMS also provided that Petitioner would be disqualified from offering a nurse aide training and competence evaluation program (NATCEP) for a period of two years. Petitioner did not operate a NATCEP at the time, and so that remedy is not at issue here.
• CMS’s determination that Petitioner was out of compliance with the non-immediate jeopardy deficiencies is administratively final as is CMS’s imposition of a $303 per day CMP for the 67 days from October 6, 2016, through December 11, 2016.

Joint Settlement Status Report, Joint Stipulation of Undisputed Facts, and Joint Statement of Issues Presented for Hearing ¶ B.

The parties further agreed that the issues were (1) whether the deficiency for section 483.65 constituted noncompliance (as defined at 42 C.F.R. § 488.301); (2) whether CMS’s immediate jeopardy determination was clearly erroneous; and (3) whether the $12,541 per day CMP for 114 days (immediate jeopardy period) was reasonable. Id. ¶ C.

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E. ALJ Decision

The ALJ issued a decision on October 23, 2020, finding Petitioner was not in substantial compliance due to violations of multiple participation requirements established by 42 C.F.R. § 483.65. ALJ Decision at 1. The ALJ Decision includes extensive summarized witness testimony, necessary because:

Although the parties agreed to most of the relevant facts, they presented witness testimony rather than simply stipulating to the undisputed facts. In this case, the witness testimony is particularly helpful for me to better understand the extremely complex issues related to TB, its identification, and treatment. For that reason, a summary of the relevant testimony is included in this decision, with weight and credibility determinations noted. No significant issues of credibility are identified, and all witnesses generally provided credible testimony except where noted. However, as addressed for certain witnesses, the weight of witness testimony is significantly affected by knowledge of the facts, including CDC guidance and Maryland law, which is set forth in some detail in this decision. Witness testimony is also summarized here as my findings of what they testified to. This is particularly necessary in this case given a significant number of errors and omissions in the transcript due to the inadequacy of microphones used during this video conference hearing, and the need to clarify with witnesses when questions and responses were muddled or confused.

Id. at 20 n.15.

The ALJ made findings of fact which included:

• In May and August 2015, Petitioner’s staff and the county conducted two rounds of TB testing of residents who might have been exposed to an employee with active TB. At least 19 or 20 residents had positive results. CXRs showed that none of the residents had active TB in 2015. It is undisputed that a positive TB test and a negative CXR shows the individual has LTBI.
• Petitioner concedes that a resident with a positive TB test and a negative CXR should be treated at some time.
• R4, identified as having LTBI in 2015, was started on treatment beginning on or about October or November 2015, pursuant to an order from a physician (not affiliated with Petitioner) in preparation for a possible kidney transplant.
• There is no dispute that the remaining 18 to 19 residents identified as having LTBI in 2015, including R1, received no treatment for LTBI until September 2016.

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• Petitioner’s TB infection control policy specifically required that someone identified with a positive TB test and a negative CXR be referred for medical evaluation for treatment.
• Unrebutted evidence shows that five percent of all persons with LTBI will convert to active TB infection within two years of exposure to TB.
• If not treated properly, active TB can be fatal, and five percent of patients diagnosed in the U.S. each year with active TB are either dead when diagnosed or die during treatment.
• Residents and staff of congregate settings such as long-term care facilities are among those at highest risk for exposure and infection.
• CDC guidance stresses that the treatment of LTBI is essential to “control and eliminate TB” because it substantially reduces the risk of progressing to active TB.
• The ALJ inferred, based on the known risks associated with TB, that Petitioner’s policy, not alleged to be defective, requires prompt action by Petitioner’s staff for all steps required for handling a TB outbreak.
• All but one resident identified as having LTBI in 2015 were never evaluated for treatment until after R1 was diagnosed with active TB; and none were referred to their primary care physicians for evaluation for treatment.
• There is no dispute that a decision was made to delay prophylactic treatment of the LTBI cases until after the second round of testing of residents was completed in 2015. There is no evidence of any agreement between Petitioner’s staff and the county or direction from the county as to how long treatment for LTBI could be delayed.
• There is no evidence that the risk posed to residents due to the delay was assessed by either the county or Petitioner. There is also no evidence that any physician was involved in the decision to delay treatment for LTBI.

ALJ Decision at 34–36.

Petitioner alleged there was a conflict of interest because the surveyor and the county health employees worked for the same state agency. P. Br. at 6-7 n.6, 36; P. Rep. Br. at 4 n.1. The ALJ explained that any alleged conflict was immaterial because his review was de novo and his decision was not based on the surveyor’s testimony or observations in the SOD, but on the testimony of the other witnesses, documents other than the SOD, and the undisputed facts. ALJ Decision at 50. The ALJ noted that Petitioner conceded that the Board has found that allegation of defects in the survey process are immaterial when there is an otherwise appropriate basis for finding noncompliance. Id. (citing P. Rep. Br. at 4, n.1). The ALJ made four conclusions of law regarding the noncompliance citation at

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the level of immediate jeopardy, and the reasonableness of the CMP based on that citation:²⁰

• CMS established a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.65. Id. at 9.
• Petitioner did not meet its burden to show it was in substantial compliance with 42 C.F.R. § 483.65 during the period June 14 through December 11, 2016. Id.
• Petitioner failed to show that the determination or duration of immediate jeopardy was clearly erroneous. Id. at 50.
• The CMP for the period of immediate jeopardy was reasonable. Id. at 58.

We will discuss the ALJ’s findings and conclusions in more detail in our analysis.

F. Proceedings before the Board

Petitioner timely requested Board review of the ALJ Decision, asserting the ALJ’s determination to uphold the deficiency for failure to comply substantially with 42 C.F.R. § 483.65 and the corresponding per-day CMP for the immediate-jeopardy period (June 14, 2016 through October 5, 2016) as reasonable must be set aside. Request for Review (RR) at 1, 24. Petitioner asserts the ALJ’s arbitrary and capricious creation of an ad hoc requirement based on an “inference of an unwritten obligation” for its staff to assume certain obligations that Maryland law specifically assigns to the county; as well as completely new obligations, and “imported those implied obligations into then Section 483.65 as regulatory requirements.” Id. at 24-25. Petitioner also asserts the ALJ Decision is not supported by the record²¹ and some of the findings of fact are inconsistent with the plain language of CMS’s Guidelines, including the ALJ’s minimization of the alleged conflict of interest.²² Id. at 27, 32-33. Finally, Petitioner asserts that there is no basis for the duration of the noncompliance. Id. at 36.

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CMS asserts there is no dispute that TB is an infection covered by 42 C.F.R. § 483.65, and Petitioner’s TB Post Exposure procedure states if a resident has a positive skin test and a negative CXR (which identifies the resident as having LTBI), the infection control plan called for evaluation for prophylaxis and that did not happen. CMS Br. at 16–17 (citing P. Ex. 6; Tr. at 1032, 1077). CMS alleges that by failing to implement its own infection control policy, Petitioner ignored its duty to “help prevent the development and transmission of disease and infection” as required by section 483.65. Id. at 18. CMS denies that Petitioner’s obligation to implement its own TB infection control policy is an “ad hoc regulatory obligation” but rather a clearly defined and well-known regulatory requirement. Id. at 20. Finally, CMS asserts that Petitioner is legally responsible for implementation of its infection control policies and procedures, regardless of what the county did or did not do. Id. CMS further asserts that Petitioner did not show that the finding of immediate jeopardy, or the duration of immediate jeopardy, was clearly erroneous. Id. at 27–33. CMS asserts that the Board should uphold the ALJ’s decision. Id. at 33.

Petitioner’s reply brief asserts the evidentiary premises for CMS’s arguments are flawed; CMS misstates the language of Maryland law; and that CMS never identified any regulatory basis for the sanction imposed. See P. Rep. Br. at 1-2, 7, 15, 17. Petitioner concludes by reasserting its position that its “staff did what the County Health Department instructed them to do, which was the extent of [its] obligations under both then-Section 483.65, State law, and its own TB Policy.” Id. at 20.

On July 2, 2024, Petitioner moved for remand and a refund of its CMP based upon the Supreme Court decision of Securities and Exchange Commission v. Jarkesy, 144 S. Ct. 2117 (2024). P. Mot. for Remand, & for Refund of CMP (P. Jarkesy Mot.). On July 12, 2024, CMS filed an opposition to Petitioner’s motion. Opp. to Mot. for Remand, & for Refund of CMP (CMS Jarkesy Opp.). By letter dated July 22, 2024, the Presiding Board Member notified Petitioner of the opportunity to submit a reply to CMS’s response within 15 days after receipt of the notice. Not. of Opportunity to Reply at 1. Petitioner filed a timely reply. P. Reply to CMS Jarkesy Opp. (P. Jarkesy Reply).

This Decision addresses Petitioner’s challenges of the ALJ Decision that we deem have merit as to the legal and factual sufficiency of the ALJ Decision involving Tag F441, and

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Petitioner’s arguments concerning Jarkesy. As explained below, we affirm the ALJ’s Decision, and deny Petitioner’s motion for relief pursuant to Jarkesy.

Standard of Review

In cases proceeding under 42 C.F.R. Part 498, the Board’s standard of review on a disputed factual issue is whether the ALJ decision is supported by substantial evidence; the standard of review on a disputed issue of law is whether the ALJ’s decision is erroneous. See Duke Ahn, M.D., DAB No. 3093, at 7 (2023); see also Guidelines – Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s or Supplier’s Enrollment in the Medicare Program (Guidelines), accessible at https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/enrollment/index.html?language=en.

“Substantial evidence” means “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Consulate Healthcare of Jacksonville, DAB No. 3119, at 11 (2023) (citing Richardson v. Perales, 402 U.S. 389, 401 (1971) (quoting Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938)). “The ‘substantial evidence’ standard is deferential.” Glenoaks Nursing Ctr., DAB No. 2522, at 6 (2013). “Under the substantial evidence standard, the Board does not re-weigh the evidence or overturn an ALJ’s choice between two fairly conflicting views of the evidence; instead, the Board determines whether the contested finding could have been made by a reasonable fact-finder taking into account whatever in the record fairly detracts from the weight of the evidence that the ALJ relied upon.” Douglas Bradley, M.D., DAB No. 2663, at 5 (2015) (internal quotation marks, brackets, and citations omitted); see also Golden Living Ctr. – Frankfort, DAB No. 2296, at 9-10 (2009), aff’d, 656 F.3d 421 (6th Cir. 2011).

Analysis

Having reviewed the entire record and considered Petitioner’s arguments along with CMS’s responses to those arguments, we affirm the ALJ Decision because substantial evidence supports the ALJ’s findings and conclusion that Petitioner was not in substantial compliance with 42 C.F.R. § 483.65.

A. The ALJ’s conclusion that Petitioner was noncompliant with 42 C.F.R. § 483.65 is supported by substantial evidence and not legally erroneous.

Petitioner requests the Board set aside the findings of noncompliance and the imposition of the CMP because any adverse outcome in this case was the direct consequence of the county’s failings, not an act or omission by Petitioner, much less an act or omission section 483.65 commanded or even addressed. RR at 40.

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There is no dispute that Petitioner had an ICP for TB. The ALJ found that Petitioner’s violation of section 483.65 was based on failing to ensure timely follow-up of the treatment and management of at least 19 residents identified as at risk for exposure to a serious infectious disease and on failing to record in the residents’ clinical records the rationale for treatment or nontreatment. ALJ Decision at 38–39.²³ The ALJ further found that CDC and Maryland guidelines, and COMAR, establish the standard of care for LTBI in long-term care facility residents, and that care would involve the treatment of LTBI absent compelling contraindications, using INH. Id. at 41. Additionally, the ALJ found that Petitioner’s policy and procedures were not inconsistent with the standard of care defined by the applicable CDC and Maryland guidelines and regulations. Id. at 42. Accordingly, the ALJ held that Petitioner did not implement its TB management policies and procedures to prevent the development and spread of active TB by ensuring that residents identified as having LTBI were treated, unless contraindicated or refused, as required by section 483.65. Id. at 46 (“One of the responsibilities established by 42 C.F.R. § 483.65 is that Petitioner ‘must establish and maintain an infection control program designed to provide a safe, sanitary and comfortable environment and to help prevent the development and transmission of disease and infection.’”).

For the reasons explained below, we affirm the ALJ’s conclusions that Petitioner was not in substantial compliance with 42 C.F.R. § 483.65.

1. Petitioner’s arguments concerning the ALJ’s creation of an ad hoc requirement as the basis for the sanction are not supported by the record.

Petitioner does not dispute that it must develop and maintain appropriate infection control policies and procedures, including policies and procedures for TB testing and control. However, Petitioner contends that the ALJ did not address the “context” for applying its TB Policy, since Maryland law, CDC guidance and its own TB Policy “specifically assign responsibility for certain aspects of TB control, including certain notification, testing, treatment, and follow up tasks at issue here,[] to the [county].” RR at 2–3 (emphasis omitted).

The ALJ summarized the essence of Petitioner’s argument as “because it did not receive recommendations from the county health department it should have no liability for its failure to control the TB outbreaks in 2015 and 2016, and the harm caused.” ALJ Decision at 45. The ALJ accepted, based on undisputed evidence in this case, that the county failed to complete blood testing of four residents; failed to ensure that Petitioner received the recommendations for treatment; and failed to ensure treatment was initiated in late 2015 or early 2016 for all residents identified as having LTBI. Id. at 46. Nevertheless, the ALJ concluded that the fact that the county did not promptly discharge

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its duties cannot be a defense for Petitioner’s failure to follow its infection control policy as required by section 483.65. Id. Petitioner disputes the ALJ’s characterization of its arguments as the county’s failures constitute a “defense” to the alleged noncompliance with its own regulatory obligation. RR at 3. Petitioner asserts the threshold evidentiary and legal questions are whether Petitioner’s staff “violated a clear agency directive, set forth in advance in any regulation, Interpretive Guidance, or anywhere else, to do something other than what they did.” Id. at 4.

Petitioner relies on the Sixth Circuit decision in Golden Living Ctr. - Mountain View, 832 F. App’x 967 (6th Cir. 2020), for the premise that because CMS never provided any notice that it might impose a sanction based on “implied obligations,” the imposition of sanctions based on such ad hoc interpretations is “arbitrary and capricious” under the Administrative Procedure Act (APA). Id. at 25–26.

The noncompliance in this case was not based on any implied obligation for which Petitioner had no notice. Rather, it arose from Petitioner’s failure to comply with its own TB infection control policy – which is specifically required under section 483.65. The regulations in Part 483 are clear that noncompliance regarding infection control could result in the imposition of sanctions. Petitioner’s ancillary argument questioned “where in the regulation (or State law, or CDC Guidance), could [Petitioner’s] staff and Medical Director find . . . the parameters [as to] when and why to shift specified responsibility from the public health agency to someone else (including themselves)?” P. Post-Hrg. Rep. Br. at 35–36 (emphasis in original). This argument is similarly flawed in that it erroneously articulates Petitioner’s responsibilities regarding infection control under Federal law.

On appeal to the Board, Petitioner reasserts these arguments in describing the various ways the ALJ erred:

• ALJ did not address the context for applying the Center’s TB Policy, starting with the undisputed fact that for more than two centuries, TB control in the United States has been, and is, primarily a local public health agency responsibility.
• ALJ determined there was no need to harmonize Petitioner’s TB policy with State law or the CDC’s guidance.
• ALJ inexplicably held that notwithstanding the clear provisions of State law and CDC guidance, it was Petitioner, and, specifically, its Medical Director and Infection Control Nurse, who failed to complete duties such as initiation of prophylaxis that State law specifically assigned to the county.
• ALJ never directly addressed the binding effect of these State laws and guidelines on Petitioner, or whether section 483.65 incorporates them as federal requirements.

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• Maryland law, the CDC’s TB guidance, and Petitioner’s own TB Policy, all specifically assign responsibility for certain aspects of TB control, including the very tasks at issue here, to the local public health authority, in this case, the county.

RR at 2-4; P. Rep. Br. at 7.

There is nothing arbitrary or capricious about the ALJ’s determination of the source of Petitioner’s responsibility as a SNF participating in Medicare. The regulation establishes the requirement for a SNF to have an infection control policy under which it investigates, controls, and prevents infections in the facility; decides what procedures should be applied to an individual resident; and maintains a record of incidents and corrective actions related to infections. See 42 C.F.R. § 483.65(a)(1)–(3). The overarching premise of Petitioner’s position is that section 483.65 says “nothing at all about TB”; CMS’s SOM indicates SNFs “should follow specific State law and [CDC] guidance regarding the nuts and bolts of infection control for specific diseases”; and Maryland law and CDC Guidelines all specifically assign responsibility for certain aspects of TB control to the local public health authority, including the tasks which the noncompliance is based on. RR at 1-2, 7. Accordingly, Petitioner asserts that its determination to “defer to the county” was entirely consistent with the policy itself, State law, and CDC Guidance. P. Rep. Br. at 7 (emphasis added).

We find this argument neither persuasive nor supported by any evidence in the record. We reject Petitioner’s argument that the regulation does not apply to TB, as the version in effect at the time of the survey does not mention any disease by name, and more pertinently, Petitioner does not dispute that TB is an infectious disease. “[T]he federal requirements are based on an ‘outcome-oriented’ approach, in which the regulations establish outcomes facilities must achieve, but provide each facility with flexibility to select methods to achieve them that are appropriate to its own circumstances and needs.” Azalea Court, DAB No. 2352, at 9 (2010) (citing Virginia Highlands Health Rehabilitation Center, DAB No. 2339, at 5 (2010), citing Lake Mary Healthcare, DAB No. 2081, at 17 (2007)), aff’d, 482 F. App’x 460 (11th Cir. 2012). “[A] facility’s failure to take measures that are reasonably necessary, under the circumstances, to achieve an outcome required by the regulation” may establish “noncompliance, even though the regulation does not specify the particular measures that the facility must or may take to achieve these outcomes.” Azalea Court at 9. Moreover, Petitioner had a specific infection control plan for TB. It is the implementation, or lack thereof, of that plan that forms the basis for the noncompliance determination.

Petitioner’s assertion that the CDC and Maryland Guidelines, and COMAR specifically assign the initiation of prophylaxis to the county is not supported by the evidence. Petitioner argues that both the Maryland TB Guideline (CMS Ex. 39) and CDC guidance (P. Ex. 4, at 2; see also CMS Ex. 53, at 25) provide that the local health department is

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responsible for ensuring that all persons who are suspected of having TB are identified and evaluated promptly, that an appropriate course of treatment is prescribed and completed successfully, and regardless of where a person receives medical care, the public health agency is primarily responsible for ensuring the quality and completeness of all TB-related services. RR at 12–13.

Petitioner’s argument is misplaced. The Maryland Guideline Petitioner relies on specifically refers to individuals with “suspected” TB or those confirmed to have active TB, not LTBI (emphasis added), and it requires the local health department to ensure that certain actions be taken, not requiring they be done only by the local health department. See CMS Ex. 39, at 10. The CDC guidance states “[c]ertain considerations for control of TB in hospitals apply also to extended care facilities, including 1) maintaining a high index of suspicion for the disease; 2) promptly detecting cases and diagnosing disease; 3) isolating infectious persons and initiating standard therapy . . . .” See CMS Ex. 53, at 60. Finally, Petitioner relies on CDC guidance stating that among the responsibilities of the local health department is to “medically evaluate and treat” and “plan for treatment and follow up of contacts.” RR at 13 (citing P. Ex. 4, at 6-7, 10); see also CMS Ex. 40, at 45. However, the first quoted phrase is incomplete. The cited language states, in full, that “[h]ealth departments are responsible for ensuring that TB contacts are medically evaluated and treated.” See P. Ex. 4, at 6 (emphasis added). As previously stated, this does not require that the local health department itself perform the evaluation and treatment, but it must confirm or make sure that it is done. Moreover, none of this guidance absolves nursing homes of their responsibilities under 42 C.F.R. § 483.65 or makes local health departments exclusively responsible for preventing the development and transmission of TB in nursing homes.

Similarly, the “plan for treatment and follow-up of contacts” is again only a portion of the complete reference contained in the document. Id. at 10. The quoted language is found in the “Recommendations for Contact Investigations and for Outbreak Prevention and Response” section, and the topic of the cited provision is “TB-control programs should develop outbreak response plans for their jurisdictions.” Id. Another Guideline in the record addresses “Recommendations for TB Control in Health-Care Facilities and Other High-Risk Settings.” See P. Ex. 4, at 11-12; CMS Ex. 53, at 69-70. It states that residents admitted to long-term care facilities with TB infection should be offered treatment if indicated. Id. Simply put, no Guideline or guidance puts the sole responsibility for treatment and infection control on the local health department. Finally, as CMS points out, the Maryland Guidelines state either the local health department or a private provider may be responsible for prescribing an appropriate treatment regimen and ensuring it is adhered to and completed. See CMS Ex. 39, at 10. The treatment regimen, with listed medication, dosage, and duration, is also contained in this document. See id. at 20–21. The COMAR language only requires that the county health department recommend appropriate treatment for LTBI. See COMAR § 10.06.01.21(B)(2).

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The ALJ addressed these arguments, and held:

Petitioner provides no reasoned and supported argument that it should be relieved of the responsibilities to its residents it undertook when enrolling in Medicare. While the county had a duty under [COMAR] to recommend treatment for those residents with [LTBI], Petitioner should have been concerned with ensuring that none of the residents converted to active TB, exposing all staff and residents to TB and the need for treatment for [LTBI] or, much worse, active TB and possible death.

* * * *

The Maryland guidelines specify that either isoniazid (INH) or rifampin is used for treatment of latent TB infection for six to nine months depending on the treatment regime. Therefore, even absent a specific recommendation, Petitioner could have anticipated that the recommendation would be one antibiotic or the other. Further, Petitioner could have provided the Maryland guidelines to the residents’ treating physicians and then relied upon those physicians to issue appropriate orders for treatment. The Maryland guidelines specify that a private provider undertaking to treat one with TB is undertaking a public health function that includes prescribing an appropriate treatment regime and ensuring adherence to that regime until treatment is completed. Therefore, the Maryland guidelines specifically provide for a private provider ordering and treating one with TB and impose the obligation to ensure that treatment is completed.

* * * *

Petitioner asserts there is nothing in the regulations that shifts responsibility for handling a TB outbreak to [its] staff or medical director. Petitioner overlooks, however, its responsibilities under 42 C.F.R. § 483.25 to ensure its residents receive necessary care and services . . . [and] its own policy, which places upon [its] staff the responsibility to ensure medical evaluations for treatment are accomplished for those with [LTBI]. . . . The fact the county was not fulfilling its duty is no excuse for Petitioner’s failure to fulfill its duty to its residents. In this case, Petitioner’s own policy required [it] to ensure that medical evaluation for treatment of

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[LTBI] was done, and [it] failed to follow that policy, which is the basis for the deficiency citation.

ALJ Decision at 47–49 (internal citations omitted).²⁴

In order to participate in Medicare, a SNF must meet that program’s requirements for participation. Act § 1819(a)(3), (b)-(d); 42 C.F.R. § 483.1. The chief purpose of those requirements, and of the laws adopted to enforce them, is to promote and protect the health, safety, and rights of a SNF’s Medicare residents. See Avon at 2 (citing Act § 1819(f)(1)); see also Northeastern Ohio Alzheimer’s Research Ctr., DAB No. 1935, at 8 (2004) (discussing the “regulatory goal” of the enforcement scheme for Medicare-participating SNFs). The ALJ correctly held that Petitioner had an independent obligation under the Federal regulations to establish and maintain an ICP to provide a safe and sanitary environment, and help prevent the development and transmission of TB, and to timely and fully implement protocols called for by its infection control program after the TB exposures in 2015: (1) medical evaluation for prophylactic treatment of residents with LTBI; and (2) administering appropriate prophylactic treatment to residents with LTBI. See 42 C.F.R. § 483.65; CMS Ex. 30, at 8; CMS Ex. 53, at 17 (CDC recommended strategies for controlling TB in the United States include identification of people with LTBI that are at risk for progression to active TB and treatment with an effective drug regimen); see also P Ex. 6, at 2, 6-7 ( Petitioner’s infection control policy required it to follow its own post-exposure policy to “proceed with evaluation for chemoprophylaxis” for residents with LTBI and determine treatment needed for patients; the purpose of those protocols is to help prevent the development of active TB for those determined to have LTBI, which in turn serves to minimize or control the spread of infectious disease having the potential to cause serious or life-threatening

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illness to all residents). Nothing in that process was dependent on involvement of the county.

The Board has held that the facility’s policy may also show the “standard of care the facility expected its staff to provide”). Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB No. 3036, at 14 (2021) (citing Oxford Manor, DAB No. 2167, at 5 (2008)). Petitioner’s failure to implement the protocols (absent evidence that they were unnecessary or violated professional standards of care) constitutes noncompliance with section 483.65. The Board has long held that the regulation requires a SNF not only establish, but “maintain” – implement – the policies and procedures of its infection control program. See Golden Living Ctr. – Superior at 7; see also Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566, at 12 (2014) (holding that section 483.65 “can only reasonably be interpreted as requiring not just that an infection control policy exist, but also that the policy be followed”), appeal dismissed, 14-60388 (5th Cir. 2014); see also The Windsor House, DAB No. 1942, at 60 (2004) (stating that section 483.65 “makes clear that it is not enough simply to have an infection control program, but the facility must also follow the precautions established in that program”); Park Manor Nursing Home, DAB No. 2005, at 60 (2005) (stating that section 483.65 “can reasonably be read as requiring the facility to implement an effective infection control program in [its] daily interaction with residents”).

As such, there was a regulatory obligation for Petitioner to implement its infection control policy, not an ad hoc requirement created by the ALJ. Having determined a regulatory obligation, we turn now to whether the ALJ erred in determining that CMS met its burden to establish noncompliance, and Petitioner failed to show substantial compliance by a preponderance of the evidence.

2. Substantial evidence in the record supports the ALJ’s finding that Petitioner was not in substantial compliance with 42 C.F.R. §65.

The noncompliance determination included the failure to implement infection control protocols specifically designed and intended to contain an outbreak of a contagious disease. In 2015, at least 19 residents, including R1, had positive TB tests and negative CXRs, indicating those residents had LTBI. The undisputed standard of care according to the CDC, Maryland Guidelines, and the expert witnesses, is treatment of LTBI to avoid progression to active TB, except when treatment is contraindicated or refused. See ALJ Decision at 41, 57 (citing for CDC: CMS Exs. 41, at 55; 53, at 17, 60, 70; P. Ex. 4, at 7; for Maryland: CMS Exs. 30, at 8; 39, at 12–14, 19, 20–21, 28-30, 59; testimony of both expert witnesses: CMS Ex. 49, at 131; P. Ex. 31, at 13–15; Tr. 713–14). Petitioner conceded that any resident with a positive skin test and negative CXR (LTBI) should be treated. P. Post-Hrg. Br. at 3; see also Tr. at 864 (Genesis Vice Pres. of Medical Affairs), 1032 (ICRN), 1094 (DON). Petitioner’s own policy states that all patients exposed to TB will be screened based on guidelines from the state/local agency to reduce the risk for TB

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among patients and to provide appropriate management post exposure, to include following the post exposure procedure requiring “evaluation for chemoprophylaxis” for patients with positive TB tests and negative CXRs to “determine treatment needed for patients.” See P. Ex. 6, at 1, ¶ 2.2.1, ¶ 3.5.

a. Petitioner did not obtain medical evaluation for prophylactic LTBI treatment as required by its infection control policy.

Petitioner conceded that no diagnosis of LTBI was noted in any of the resident’s clinical records, and there were no care plans for dealing with LTBI for the 19 residents because no physician from the county or the facility rendered such a diagnosis. ALJ Decision at 38 (citing Tr. at 143–44). The undisputed evidence is that planning for treatment in this case was done from the very first meeting in May of 2015. The county told Petitioner’s leadership and the ICRN that Petitioner would be responsible for treating its residents. Petitioner understood from the outset that it was responsible for the administration of LTBI prophylactic treatment. Tr. at 478, 575, 996.

The ICRN testified that to her recollection, prior to 2015 there had not been a TB case at Petitioner’s facility in 25 years, and as a result, the facility requested the county provide treatment recommendations.²⁵ Tr. at 975–76. The ICRN stated, “We’re just not familiar with what a resident would be put on specifically for this type of exposure that we were dealing with . . . we were asking for recommendations as far as the type of medication, duration. I was not familiar with what would be the standard.” Id. at 999–1000. The ICRN further testified that prior to contacting the county for any reason, she was required to consult with the Genesis Sr. VP of Medical Affairs. Id. at 977–78. The ICRN’s recollection of any discussion at the initial meeting with the county regarding medication was limited to responding to a question as to whether the county would provide the medication, indicating no, the facility would provide the medication, but no specifics as to what medications would be involved, or the timing of prophylaxis, or categories of who would receive it. Id. at 996, 999.

Petitioner’s Med. Dirs. (Dr. P (2015) and Dr. A (2016)) did not testify at the hearing, but both the county Nurse Administrator and county Case Manager testified that in the early stages of the contact investigation, when the notification letters were being drafted (which Dr. P was going to sign along with the County Health Officer), there was a conference call with Dr. P and the subject of follow-on treatment was addressed. See Tr. at 526, 583. According to the county Nurse Administrator, Dr. P clarified that he was ok

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with Petitioner doing the follow-on treatment for the residents and asked what was usually recommended for prophylactic treatment, to which she replied, “[INH] and vitamin B6 for nine months” and “he seemed familiar with that by his response” of “‘Oh, yeah.’” Id. at 526–29. The county Case Manager testified that in a conversation involving prophylactic treatment being done by Petitioner, Dr. P replied, “Oh yeah, INH and B6, Yeah, I know.” Id. at 583.

Petitioner’s infection control policy’s intended purpose was to reduce the risk for TB among patients and to provide appropriate management post exposure. P. Ex. 6, at 1. For patients with positive skin tests but negative CXRs, Petitioner was required to proceed with medical evaluation for chemoprophylaxis. Id. at 6–7.

While Petitioner’s initial request to the county for recommended treatment was appropriate at the time it was made, that did not end Petitioner’s responsibility under its own policy. Petitioner asserts that it applied or implemented the “tasks” of recommending and initiating treatment by “defer[ring]” to the county. P. Rep. Br. at 7. Therein lies the problem. Petitioner, not the county, had the responsibility to provide treatment and management of multiple residents identified as having been exposed to active TB, specifically to evaluate the residents for prophylactic treatment. Much was made about the absence of a diagnosis in the records, but whether the diagnosis was documented or not, Petitioner was awaiting treatment recommendations – which implies that the residents had a medical need for treatment, unless contraindicated. Petitioner’s reliance on the absence of a documented diagnosis argument is misleading, as the testimony of Petitioner’s witnesses indicated that diagnoses were only documented when medications (treatment) were ordered. In summary, Petitioner knew its own policy and procedure established a need to evaluate the infected residents for treatment, and that did not happen in 2015.

Counsel and the ALJ questioned Petitioner’s ICRN and DON as to when a “diagnosis” for LTBI or a positive TB skin test would be entered in a resident’s clinical record. The DON agreed that if a resident had a positive skin test and a negative CXR, that is diagnostic of LTBI, but would not be considered a “new diagnosis” because the resident “is not on any medication.” Id. at 1077–78. The ALJ stated, “Well, it would still be a diagnosis, even if you’re not treating it” (id. at 1078), to which the DON replied, “The doctors don’t (inaudible) a diagnosis on the patient’s chart. We are not also going to note it because there was nothing to document on that patient since there was no signs or symptoms of TB to monitor.” Id. The DON also testified that if a resident tests positive for TB exposure and has a negative chest x-ray, Petitioner’s staff simply monitors for symptoms of active disease. See id. at 1086–88. That approach to residents having LTBI is not consistent with Petitioner’s infection control policy, requiring the facility to “proceed with evaluation for chemoprophylaxis.” P. Ex. 6, at 6. Additionally, Petitioner’s ICRN testified that no treatment from an outside physician would have been

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provided to a resident unless the attending agreed with it, and independently issued an order for said treatment. Tr. at 1058–61 (emphasis added).

The ALJ summarized the DON’s testimony as “no, our facility does not document a diagnosis of [LTBI] . . . all nurses know they’re supposed to monitor for conversion to active TB” to which the DON said “yes”; and “so the fact that a patient may have [LTBI], you’re not really treating them any differently, is that correct?” to which the DON replied “No, we don’t treat them differently.” Id. at 1079–81. The ALJ noted the DON’s “suggestion” that only monitoring of a resident with LTBI is all that is required is clearly at odds with CDC guidelines. Id. The ALJ found this portion of the DON’s testimony not credible, but indicated even if it was, it did not outweigh Petitioner’s policy and procedure that required medical evaluation for treatment for a resident identified as having LTBI. See ALJ Decision at 42-43.

While we agree that the testimony is difficult to reconcile on its face, the DON’s testimony was consistent with the absence of documented diagnoses of LTBI in the residents’ records, and the ICRN’s testimony that medication orders had to be initiated by an attending physician, which was not done until the fall of 2016 for all residents except R4. Compare Tr. at 1075–79 (DON) with Tr. at 1036–42 (ICRN).

Before the Board, Petitioner contends that nowhere does its policy say that an evaluation for prophylactic treatment must be – or even should be – performed or ordered by a resident’s primary care physician. P. Rep. Br. at 9. Again, Petitioner ignores the very language in its own TB infection control plan which explicitly states to follow its post-exposure procedure to determine treatment needed for patients. See P. Ex. 6, at 2. The infection control plan applies to Petitioner’s staff, not the county or any other outside medical provider. Moreover, that is consistent with the very same Maryland Guideline cited above which states that individuals with a positive skin test “should be examined by a provider,” not a health officer, “to rule-out [active] TB disease and be evaluated for treatment of [LTBI].” See CMS Ex. 39, at 19. Petitioner further contends CMS cannot dispute “that the timing of when nursing facilities can ‘treat’ residents is triggered by the receipt of valid orders.” P. Rep. Br. at 11. Again, while true, this statement evades the evidence that Petitioner’s practice required those valid orders be initiated by a facility physician. Additionally, Petitioner contends that the threshold issue is not “whether some twenty residents required evaluation for prophylaxis at some point . . . but who would do the evaluations and give the necessary prophylaxis orders.” Id. (emphasis in original). Petitioner argues that in requesting the county medical director evaluate and prescribe prophylaxis orders, they had “initiated” such evaluations and therefore had done what its policy required. Id. Finally, Petitioner asserts that it was not unreasonable for the ICRN to continue to wait on the county health department even after January 2016, because there was an agreement to delay treatment for LTBI until after the second round of testing was done. See RR at 15–16, 33–34.

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We do not find these arguments persuasive. The ALJ correctly noted that there was no evidence that any of the Petitioner’s attending physicians, Medical Director, or the county health medical director were involved in the decision to delay treatment. See ALJ Decision at 35–36. The ALJ further noted that CMS’s expert witness opined that while the decision to delay treatment was acceptable, the residents should have been diagnosed with LTBI not later than September 2015. Id. at n.17 (citing CMS Ex. 49, at 53-54). Petitioner ignores its independent obligation to manage and evaluate for prophylactic treatment multiple residents identified as having been exposed to active TB, to prevent conversion of even one resident to active TB. Furthermore, Petitioner only requested the county provide evaluation and recommended treatments, but never received any recommended treatment orders.

Petitioner further points out that the county exhibited no urgency about treatment at any time in 2015. RR at 16, 19. Whether the county expressed any urgency is inconsequential to the lack of action by Petitioner – who had the obligation to implement its infection control policy. The county inquired about whether the treatment had been started in November of 2015. The ICRN response of “nothing had been started” did not in any way indicate it could not start treatment because it had not received the recommended treatment orders, but only said it had a new medical director, “when is a good time to talk . . . We will need to coordinate process.” See P. Ex. 18, at 4-6. We disagree with Petitioner’s assessment that the county “conceded the obvious” that one could interpret this email communication to mean Petitioner was still awaiting the treatment recommendations. See RR at 33 (citing Tr. at 617). Moreover, Petitioner’s expert witness testified that even without recommendations from the county, Petitioner had the ultimate responsibility to ensure residents with LTBI received prophylactic treatment. See Tr. at 713.

In summary, we find that Petitioner never obtained the medical evaluations for appropriate LTBI treatment required by its infection control policy.

b. Petitioner did not appropriately manage residents found to have LTBI in accordance with its own TB Infection Control Policy.

The purpose of Petitioner’s own policy was to reduce the risk for TB among patients and provide appropriate management post-exposure. See P. Ex. 6, at 1. Petitioner’s policy and procedures required assessment and management of any resident who had a positive TB skin test in the 2015 post-exposure testing. Federal regulations required an infection control plan to investigate, control, and prevent infections in the facility. See 42 C.F.R. § 483.65(a)(1). Petitioner’s own policy further required that if a TB exposure occurs in the facility, Petitioner will conduct an investigation “per state guidelines” and screen exposed residents “based on guidelines from the state/local agency.” P. Ex. 6, at 1. Maryland regulations require a facility to conduct annual symptom review and assess and manage a resident with a history of previous positive TB skin test, previous history of

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active TB, or positive skin test conversion in accordance with CDC Guidelines. See COMAR § 10.07.02.21-2(B)(1), (4), (5).

As noted above, counsel for both parties and the ALJ spent a good deal of time asking questions regarding when a diagnosis would be entered, as well as when a “change of condition” would be documented for a resident with LTBI, when a care plan would be updated to monitor for signs and symptoms of active TB for a resident with LTBI, and whether a resident’s LTBI status would be included when residents received CXRs ordered for reasons unrelated to the TB screening process, or a resident was transferred to a hospital for any reason. See Tr. at 1032–53; 1073–88. The ALJ eventually narrowed the focus, stating “I’m not seeing any evidence that the interdisciplinary team [IDT] for each . . . of the 19 residents were actually informed of the latent TB diagnosis so that they could actually develop a care plan that included monitoring for signs and symptoms of active TB or conversion.” Tr. at 1036.

The ICRN testified the IDT members were aware of the positive skin tests but did not believe the care plans were updated until 2016; she would have been involved if they were and those actions did not require direction or guidance from the county. Id. at 1037–40.

The ICRN also testified that a finding of LTBI would trigger an update of the care plan for symptom surveillance, but a care plan would not be changed based solely on a positive skin test or positive QFT-G, but she did not know why. See id. at 1039, 1042–44. When asked by the ALJ if any additional monitoring would be required once CXR results were available, the ICRN testified “we would do the annual symptom surveillance” and then clarified that “the standard would be annually, and then when a resident presents with signs and symptoms, we would have to do that [monitor].” Id. at 1044. The ALJ followed up, asking, “So for nursing staff, and particularly since you had PRN²⁶ staff, to understand that they needed to be particularly attentive to signs and symptoms of conversion from latent to active [TB], would that not need to be somewhere in the care plan, arguably?” Id. at 1044. The witness responded, “yes, there should be a care plan.” Id. at 1045.

The ALJ explained the underlying basis for this line of questioning:

[Counsel], I’m fully aware that the facility was not cited for care planning deficiency, they weren’t cited for [Minimum Data Set] deficiency. I fully understand, and I’m not going to add any citations to the deficiencies. Don’t worry. That’s not – that’s not generally what I do. So don’t worry about that.

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But I think I need to get some honesty here that there were things that this facility could have and should have done without waiting for the county to tell you what to do next.

There are certain things that are directed by the federal regulations, right? . . . So I just want to make sure that it’s clear that I understand what’s actually required of this facility when you get a positive diagnosis, note something.

Id. at 1045. Petitioner’s counsel did not disagree with the ALJ’s line of questioning, and indicated the DON might be a better witness to address these issues. Id. at 1045–46.

The DON testified that on admission, it was not Petitioner’s practice to update a resident’s care plan following a positive skin test and negative CXR, stating “[w]e continue to monitor the patient for any unusual signs and symptoms, and we report to the physician.” Id. at 1075. The DON also stated that with a positive skin test and negative CXR, the care plan would be updated “if the patient was placed on medication like INH, Vitamin B”, and “we monitor for any unusual signs and symptoms, and we report to the physician.” Id. at 1076. The DON stated that care plans were updated for R4 in 2015, as well as for the residents who were put on prophylaxis in the fall of 2016. Id. at 1076–77.

CMS argued in its post-hearing brief, but did not cite to any reference document, that annual monitoring for signs and symptoms of active TB was inadequate for residents with LTBI, relying on the declaration and deposition testimony of its expert witness. See CMS Post-Hrg. Br. at 12–16; see also CMS Exs. 42 (Dr. M’s declaration) ¶ 73; 49, at 87–88, 104–106 (Dr. M’s deposition testimony that in the absence of treatment for LTBI, a strict monitoring schedule should be adhered to over the 2 years following exposure). The ALJ agreed “that annual monitoring is probably not adequate” but declined to find the monitoring to be deficient based on the absence of any citation that Petitioner’s infection control policy was inadequate. See ALJ Decision at 43 n.24. Before the Board, CMS acknowledges that Maryland regulations only require annual symptom review. See CMS Br. at 5; see also COMAR § 10.07.02.21-2(B)(4).

When the testimony is analyzed in context, it is clear that the actions, or inactions, of Petitioner all hinge on a determination, finding, or diagnosis of LTBI accompanied by an order for medication. Here, there had been no treatment ordered as Petitioner was awaiting recommended treatment from the county. Just as there is no evidence that any of Petitioner’s physicians or nurse practitioners were asked to evaluate the residents for treatment, there is no evidence as to whether any of the attending physicians had determined or diagnosed any resident with LTBI, or whether they knew of the fact that Petitioner was awaiting recommended treatment from the county. Nevertheless, the evidence supports there was an expectation to treat absent contraindication, which supports that there was a determination or finding of LTBI that was not documented in the residents’ records.

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The ALJ opined on why the interpretation of Petitioner’s policy by the DON and the ICRN was “inadequate to prevent or control outbreaks for TB.” ALJ Decision at 25 n.16. The ALJ used the facts surrounding R1 to illustrate this point:

[R1] was identified in May 2015 by a positive TB skin test and negative chest x-ray as having [LTBI]. [R1] was not treated for [LTBI] and was formally evaluated in May 2016, a year after initial identification, and determined not to have converted to active TB. One month later [R1] had signs and symptoms consistent with possible active TB that were not recognized as such, an oversight that may have been facilitated by the fact that [R1’s] records did not clearly reflect the TB testing in 2015 and the [LTBI], either by a clear diagnosis or a care plan for the [LTBI].

Id.

We agree with the ALJ’s determination that Petitioner’s practices were inadequate to prevent or control infections, at least those involving LTBI. Most disconcerting is the fact that both the DON and the ICRN testified that even without an order for medication, those residents awaiting treatment recommendations would somehow need to be monitored for signs and symptoms of conversion to active TB. But without independent knowledge of a resident’s TB status, or an overt entry in the resident’s clinical record, the evidence provides no basis for how any staff member would know to be alerted to signs and symptoms of TB in any resident, let alone the 19 who were identified with LTBI in 2015. The ICRN testified that she did not know if staff “focused” on a given resident’s immunization status, where the positive skin test would have been documented. ALJ Decision at 26. There is also no evidence of what, if anything, staff were instructed to do regarding monitoring these residents while awaiting suggested treatment regimens. Petitioner’s own infection control policy required appropriate post-exposure management, including monitoring those with LTBI for signs and symptoms of TB to prevent the development and spread of active TB pursuant to the federal statute and regulations.

The ALJ highlighted the fact that only partial records of seven residents with LTBI were in the record. ALJ Decision at 43 n.24. Petitioner’s post-exposure policy required a medical evaluation for patients with a positive skin test but negative CXR. See P. Ex. 6, at 6-7. Eighteen residents identified with positive skin tests in early 2015 fell into that category. Regarding R1, the ALJ found the nursing notes recorded R1’s signs and symptoms in June and August of 2016 that could be consistent with active TB, but there is no mention or annotation of any concern by any staff member, or the attending physician, that these symptoms were recognized as related to TB and could indicate conversion to active TB. ALJ Decision at 43 n.24. The ALJ found the staff’s failure was “more symptomatic of a lack of competency and inadequate training than a failure to

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implement Petitioner’s infection control policy.” Id. Whether staff’s failure was indicative of lack of competence or lack of cognizance, the conclusion is the same – the residents identified with LTBI were not properly managed in accordance with the facility’s own policy to prevent the development and spread of active TB, which constitutes a failure to implement its infection control policy.

Ultimately, Petitioner’s decision not to indicate the TB status in its residents’ records detracts from its assertion that it did everything it should have done. Not everyone with a cough necessarily needs to be characterized as possibly having TB. But someone with LTBI, who presents with a cough, and coughs up bright red blood, presents a very different situation. Pursuant to its infection control policy, Petitioner was required to reduce the risk for TB among patients and to provide appropriate management post exposure to reduce the risk of residents with LTBI from converting to active TB, and that involved more than simply the administration of medication if prescribed. The purpose of testing is to identify the presence of TB infection. It does no good to test if the results are not known to staff and providers responsible for providing appropriate care to those residents, which includes monitoring symptoms.

There is no question that the county did not provide assistance to Petitioner once the 2015 contact investigation was completed for all but a handful of residents requiring QFT-G blood draws. Nevertheless, Petitioner had an independent duty to comply with its own infection control policy, mandated by participation in Medicare. Petitioner had the obligation to appropriately manage the residents with LTBI starting in 2015. Petitioner’s decision to abdicate its responsibilities to its residents and defer to the county was unacceptable. Petitioner had the obligation to do more than “what the county told them to do” and it failed to comply with those obligations. Petitioner’s policy required it to reduce the risk for TB among patients, which clearly includes residents with LTBI at risk for converting to active TB. To control LTBI, prophylactic treatment is recommended, and as discussed further below, was in fact being administered to R4 by Petitioner’s staff, with no involvement by the county health department. Petitioner did not establish that it had fulfilled the requirements of its own infection control policy to manage residents with LTBI by a preponderance of the evidence.

c. Petitioner did not provide prophylactic LTBI treatment until September of 2016 to any resident except R4.

Petitioner does not dispute that active TB is a contagious and life-threatening disease, and individuals with LTBI should be treated. Most importantly, Petitioner does not dispute that only one resident, R4, received prophylaxis LTBI treatment in 2015, and that treatment was ordered by R4’s attending physician, and administered by staff at Petitioner’s facility.

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Even if Petitioner had received treatment recommendations from the county in 2015 for the residents identified with LTBI, Petitioner’s ICRN clearly stated that no treatment from an outside source would have been provided to a resident unless their attending physician agreed with it, and independently issued an order for that treatment. See Tr. at 1058–61 (emphasis added). This process was illustrated by the events surrounding the determination to provide LTBI prophylaxis to R4 in October of 2015. A physician involved in R4’s evaluation for a kidney transplant performed a TB skin test that came back positive and prescribed INH and Vitamin B6. However, while the ICRN provided that information to the county, Petitioner did not rely on any decision by the county prior to initiating the treatment. Instead, the prescribed treatment was reviewed, approved, and independently ordered by the attending physician. Only then did Petitioner’s staff provide the INH and vitamin B6 treatment; no one from the county was involved in the treatment decision process. Id.; see also P. Ex. 20, at 2.

The example shows that it was not the county’s failure to provide a treatment recommendation that prevented the additional residents from receiving prophylactic treatment, but the facility’s failure to fulfill its responsibility under its infection control policy to evaluate the residents having LTBI for treatment. Accordingly, we affirm the ALJ’s determination that Petitioner was not in substantial compliance with section 483.65.

B. CMS’s immediate jeopardy determination, including the duration, was not clearly erroneous.

Immediate jeopardy is “a situation in which the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.” 42 C.F.R. § 488.301. The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2). The Board has held that “[t]he ‘clearly erroneous’ standard . . . ‘means that CMS’s immediate jeopardy determination’ . . . ‘is presumed to be correct, and the burden [on the SNF] of proving the determination clearly erroneous is a heavy one.’” Consulate Healthcare of Jacksonville, DAB No. 3119, at 12 (2023) (citing Mississippi Care Ctr. of Greenville, DAB No. 2450, at 15 (2012), aff’d, 517 F. App’x 209 (5th Cir. 2013) (per curiam); see also Brian Ctr. Health & Rehab./Goldsboro, DAB No. 2336, at 8-9 (2010)).

The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard. See Vibra Hospital of Charleston-TCU, DAB No. 3094, at 23 (2023) (citing Universal Health Care at 16; Brian Ctr. Health and Rehab./Goldsboro at 7–8; Owensboro Place & Rehab. Ctr., DAB No. 2397, at 12–13 (2011)).

Petitioner challenges the ALJ’s upholding of CMS’s declaration of immediate jeopardy, asserting that “CMS speculates that perhaps [R1] was developing active TB in December

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2015, or June 2016, and that her physician (and two radiologists) misdiagnosed her (ostensibly because they were flying blind because [Petitioner] did not document her LTBI in her nursing facility chart a certain way)”; and because there was no actual noncompliance, the imposition of a sanction based on R1’s conversion to active TB due to Petitioner’s failure to provide timely prophylaxis to R1, is based on “fatal evidentiary (and legal) flaws.” RR at 36–38; P. Rep. Br. at 15–17 (emphasis omitted).

As discussed above, noncompliance was established. Furthermore, the ALJ found that based on the “undisputed risks for serious harm or death secondary to a conversion to infectious TB posed by even one resident in a long-term care environment, I would have no trouble concluding immediate jeopardy existed beginning no later than August 2015.” ALJ Decision at 57. The ALJ further concluded that R1 “suffered actual harm” because of the failure to receive treatment for LTBI in 2015 and LTBI “converted to active TB” in 2016. Id. at 56. Moreover, in June of 2017, the “genotype” of R1’s TB was determined to be the same as staff member #1’s TB. See CMS Ex. 47. For the same reasons discussed above, Petitioner’s failure to follow its own policy and procedures to treat residents identified as having LTBI was directly related to R1’s disease progression from LTBI to active TB. There is nothing in the partial clinical record for R1 that shows she had a history of TB exposure prior to 2015. See CMS Ex. 5, at 5 (R1’s annual symptom surveillance dated May 09, 2015 showing test results as NA, and evaluation of results indicating annual monitoring only); 2, 29-30, 36 (showing positive skin test on May 26, 2015, order for CXR to rule out TB, negative CXR results); compare P. Ex. 11, at 3 (showing R1’s name with no annotation of prior history (hx)) with id. at 4 (showing another resident with annotation of “Hx+”). There is no ambiguity or conjecture as to the source of R1’s exposure in 2015 and later disease progression.

Petitioner’s position is that “CMS simply assumes that [R1’s] disease must have progressed because of some (unexplained) breakdown in [Petitioner’s] implementation of its infection control or TB policies.” P. Rep. Br. at 16 (emphasis omitted). Petitioner further asserts that “even where the record supports a finding of some noncompliance . . . the record also must contain an evidentiary basis from which the ALJ or Board can infer that death or serious harm to one or more residents actually had been caused by, or was the ‘probable’ or ‘reasonably to be expected’ result of, the alleged noncompliance, and not just – to use CMS’s own words – ‘possible,’ ‘potential,’ or ‘mere risk.’” Id. at 16–17 (citing Oak Ridge Center, DAB No. 2913 (2018) and Golden Living Center – Trussville, DAB No. 2937 (2019)).

We find these arguments unpersuasive and contradicted by the record evidence. Again, Petitioner ignores the requirement to comply with its regulatory responsibility to implement its TB infection control policy with the stated purpose to reduce the risk for TB among patients and to provide appropriate management post exposure. To the extent that Petitioner suggests that it could not provide treatment to the residents identified as having LTBI unless and until the county prescribed treatment, that position is both

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factually and legally incorrect. Furthermore, as discussed above, any treatment provided to a resident had to be ordered by the attending physician/nurse practitioner – even if another physician outside the facility had prescribed treatment. Many of the CXR orders signed by the facility physicians/nurse practitioners did indicate “TB test reaction” as the reason for the order, and most of those orders show the results were telephonically relayed to a named facility physician/nurse practitioner. See P. Exs. 9, 13. There is no evidence, documentary or testimonial, to establish whether the attending physicians or nurse practitioners for any of the residents identified as having LTBI were informed of the policy’s requirement to evaluate for prophylaxis when those CXRs ruled out active TB. Petitioner conceded that no diagnosis of LTBI was noted in any of the resident’s clinical records because no physician from the county or the facility rendered such a diagnosis. ALJ Decision at 38 (citing Tr. at 143–44). But there is no explanation as to why such a diagnosis was not made when treatment recommendations were pending.

The ICRN testified that R1 had a history of emphysema and chronic obstructive pulmonary disease (COPD), along with other diagnoses, before May 2015. ALJ Decision at 26; see also Tr. at 1027. The ICRN also testified that R1 had a positive skin test and negative CXR during the first round of testing in May 2015, but was not exhibiting any signs or symptoms of TB. ALJ Decision at 26; see also Tr. at 1026. The ALJ interpreted this evidence to indicate R1 had LTBI, but that “is not reflected by the few documents from [R1’s] clinical record in evidence” and the ICRN was “not aware whether R1 was considered to have a change in condition in 2015 when testing showed LTBI” and agreed that a review of nursing notes in 2016 (P. Ex. 10, at 1–4) did “not indicate that [R1] had [LTBI].” ALJ Decision at 26. We have previously discussed the ICRN’s testimony that staff may not have focused on the resident’s immunization status where the positive skin test would have been documented; that a determination” that a resident had LTBI would trigger an update to a resident’s care plan for symptom surveillance, but did not believe the IDT updated any resident’s care plan based on the fact that testing showed a resident had latent TB; and that changes to a resident’s care plan would “involve no direction or guidance from the county. See infra, citing Tr. at 1032–39. The ICRN’s testimony also included that she did not believe that [LTBI] had been added to [R1’s] or any resident’s “face sheet,” a document which follows a resident when transferred to a hospital. See Tr. at 1035. While there was no testimony as to whether or not the record contained a face sheet for any resident, the first page in R1’s clinical record shows a date and time of “Dec. 3, 2015 15:41:57 ET” and LTBI is not shown as a diagnosis, and the listed diagnoses were entered at admission seven months earlier. See CMS Ex. 5, at 1.

The record clearly establishes that R1’s attending physician ordered the initial CXR to rule out active TB and was notified of the negative result. The same attending physician also ordered the CXR in June of 2016, diagnosed the resident with bronchitis, and then in early August 2016, when R1 was coughing up blood, ordered R1 to be transferred to the hospital. Id. at 6–8, 47, 50, 61. The evidence regarding the transfer is disconcerting in that the date of transfer shows “10/27/2015” but shows “report called in” and “date sent”

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as August 8, 2016; contains “Resident observed with bright red moderate bleeding from her mouth” but the “Reason for transfer” is listed as “Other – GI bleeding” and there is no mention of TB status or possible conversion to active TB. See CMS Ex. 5, at 6–7. The surveyor interviewed R1’s attending physician and testified that the doctor “did not recall” if R1’s TB status was documented in 2015. While that response is corroborated by the testimonial evidence and the minimal clinical record evidence provided, it provides no meaningful evidence of whether the attending physician was aware of R1’s TB status, and how, if at all, the attending physician factored that information into the medical symptoms R1 experienced throughout 2015 and 2016 prior to being diagnosed with active TB. We find the totality of information associated with the transfer to be compelling evidence that TB was not considered by the facility at the time of transfer.

Petitioner’s argument that the county failed to comply with its requirement to make specific prophylaxis recommendations for residents who had tested positive for exposure does not “justify” or absolve its own failure to implement its own TB infection control policy and procedures. Petitioner provided no evidence that the attending physicians or nurse practitioners were asked to evaluate the residents determined to have LTBI for prophylactic treatment or asked to order LTBI treatment; and if not, why not. We agree with the ALJ’s assessment that the absence of documentation means that there is little or no documentation that Petitioner’s staff actually did what was required by its policy and procedures, i.e., medical evaluation by physicians to determine the best plan of care including treatment for LTBI, if not contraindicated, and monitoring. Given these circumstances, Petitioner’s failure to implement post-exposure TB procedures fully or promptly, namely medical evaluation, prophylactic treatment and appropriate management of the infected residents, was likely to cause serious harm to residents. In addition to the harm directly to those residents who could convert to active TB, they would now be contagious and pose a risk to expose the remaining residents to TB. The ALJ noted the CDC Guidelines found treatment of LTBI can reduce the risk for death due to conversion to active TB, and correctly concluded for all residents with LTBI there was a risk for actual harm due to the risk for death associated with conversion to active TB, as demonstrated by R1. ALJ Decision at 41, 43. Thus, the ALJ did not err in concluding that CMS’s immediate jeopardy determination was not clearly erroneous.

The county was not involved in the prophylactic treatment ordered and provided to R4 by Petitioner’s staff. The treatment regimen prescribed for R4 was exactly the same as what the county health department prescribed in 2016 – INH 300 mg daily together with Vitamin B6 50 mg daily – and corresponded to the regimen and dosage provided in CDC guidance. See P. Ex. 14; P. Ex. 26; CMS Ex. 30, at 18; CMS Ex. 39, at 20, 22. CMS’s determinations of noncompliance and immediate jeopardy and the ALJ’s upholding of those determinations are based on failures of Petitioner to implement its TB infection control policy. In short, Petitioner made no meaningful attempt to carry its heavy burden to show clear error by CMS.

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Accordingly, we affirm the ALJ’s finding that Petitioner failed to establish that CMS’s declaration of immediate jeopardy was clearly erroneous.

Petitioner also challenges the ALJ’s upholding of CMS’s determination regarding the duration of the immediate jeopardy period, that is, that residents were in immediate jeopardy from June 14 through October 5, 2016. Petitioner argues that “it is not at all clear what, if anything, these dates have to do with the noncompliance CMS alleged or the ALJ actually sustained.” RR at 36. We reject Petitioner’s assertions.

The SOD did not contain a start date for the immediate jeopardy, which the ALJ noted as “odd” at the hearing, but the CMS determination notice did. See Tr. at 59–60; see also CMS Ex. 20. At the hearing, CMS argued that the inception of immediate jeopardy of June 14, 2016, was a “typo” and should have been June 4, 2016. Tr. at 56–57. The ALJ stated that changing the start date of immediate jeopardy is not a matter of “correcting a typographical error,” but is instead a substantive change in the enforcement remedy proposed by CMS that would increase the CMP by more than $120,000. Tr. at 56–57, 62, 65–66; see also ALJ Decision at 58 n.30. The ALJ further held that CMS can only reopen and revise its initial determination within 12 months of the date on the notice of the initial determination, and here, counsel raised this issue more than 18 months after the date of the initial determination. Tr. at 66–67; ALJ Decision at 58 n.30 (citing 42 C.F.R. § 498.30). CMS articulated that the choice of the start date of non-compliance at the immediate jeopardy level was an exercise of “selective enforcement,” asserting Petitioner could have been cited in September of 2015. See Tr. at 122–25.

The ALJ found that the evidence showed that R1 was identified as having LTBI in 2015, was provided no treatment for LTBI, and as a result developed active TB no later than August 2016. ALJ Decision at 49. The ALJ also found that based on the “undisputed risks for serious harm or death secondary to a conversion to infectious TB posed by even one resident in a long-term care environment, I would have no trouble concluding immediate jeopardy existed beginning no later than August 2015.” Id. at 57. Nevertheless, the ALJ did not disturb CMS’s exercise of discretion and concluded the immediate jeopardy existed no later than June 14, 2016, and ended October 5, 2016. Id. at 58. The ALJ further found Petitioner had not shown that the duration was clearly erroneous. Id.

The Board has previously held that a facility’s noncompliance, or failure to meet a participation requirement, “is what constitutes the deficiency, not any particular event that was used as evidence of the deficiency” and “there is no requirement that the duration of a remedy coincide with particular events that form the evidence of lack of substantial compliance.” Regency Gardens Nursing Ctr., DAB No. 1858, at 21 (2002) (citing 42 C.F.R. § 488.301). Furthermore, the Board has held that CMS is not “under any compulsion to explain why it decides not to impose remedies on days for which it might do so. From the provision that remedies may be imposed as early as the first day

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of noncompliance, it follows that CMS may choose to begin any remedy at a later date.” Id. at 10 (emphasis omitted); see also Mountain View Manor, DAB No. 1913, at 6 (2004) (upholding CMP beginning on May 25 because immediate jeopardy existed as of that date, despite unclear reasoning why that date was chosen). Still further, Petitioner made no showing that it abated the immediate jeopardy before October 5, 2016. See Owensboro Place & Rehab. Ctr., DAB No. 2397, at 12-13 (2011) (“[I]t is not incumbent on CMS to justify the [abatement] date, but, rather, on [the facility] to show an earlier date of abatement . . . .”).

Accordingly, we find no error in the ALJ’s conclusion that CMS’s determination concerning the duration of immediate jeopardy (June 14, 2016 through October 5, 2016) was not clearly erroneous. See 42 C.F.R. § 498.60(c)(2) (“CMS’s determination as to the level of noncompliance of a SNF . . . must be upheld unless it is clearly erroneous.”); Brian Ctr. Health and Rehab./Goldsboro, at 7-8 (“A determination by CMS that a SNF’s ongoing compliance remains at the level of immediate jeopardy during a given period constitutes a determination about the ‘level of noncompliance’ and, therefore, is subject to the clearly erroneous standard of review under section 498.60(c)(2).”).

As Petitioner “does not contend that [the per day CMP amount] is unreasonable based on the relevant regulatory factors,” we “find no basis for disturbing the ALJ’s conclusion that the amount of the CMP was reasonable.” See Lutheran Home at Trinity Oaks, DAB No. 2111, at 22 (2007); see also Glenoaks at 27 (upholding CMP amount where petitioner did “not contend . . . on appeal . . . that any particular regulatory factor did not support the CMP amounts”).

C. We reject Petitioner’s arguments based upon Jarkesy.

Concerning Jarkesy, Petitioner argues the Supreme Court “held that where, as here, an agency imposes a CMP for regulatory noncompliance, such a CMP is equivalent to a common law remedy, and thus the Seventh Amendment requires that a jury, not an ALJ, must consider a challenge to that remedy in the first instance.” P.’s Jarkesy Mot. at 1. “Accordingly,” Petitioner asserts, “this appeal proceeding was void ab initio, and so the Board should,” among other things, “hold that under Jarkesy the ALJ did not have constitutional authority to conduct this review[.]” Id. at 3; see also P.’s Jarkesy Reply at 1 (“[T]his proceeding is void ab initio.”). Petitioner further contends that “if, as Jarkesy holds, the due process necessary in a CMP appeal is a jury trial, then CMS must meet that constitutional command and return the ‘escrowed’ [CMP] funds pending such review.” P.’s Jarkesy Mot. at 3.

CMS counters that “the Board consistently has held that ALJs do not have the authority to consider constitutional challenges. Jarkesy does not invalidate those prior decisions or their reasoning that this type of constitutional challenge may not be heard before an ALJ or the DAB.” CMS Jarkesy Opp. at 1. “Therefore, there is no authority to remand based

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on a purported Seventh Amendment infirmity in the long-standing process for review of CMS enforcement actions.” Id. at 2. CMS considers Petitioner’s refund request to be “premised on the same unreviewable Seventh Amendment claim” and therefore states that the Board “must deny this request.” Id.

We reject Petitioner’s arguments for remand and refund of the CMP based upon Jarkesy. That case arose from “an enforcement action” by the Securities and Exchange Commission (SEC) pursuant to the Securities Act of 1933, the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, and the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. Jarkesy, 603 U.S. 109, 115-16 (2024). The SEC brought an enforcement action seeking CMPs from an investment advisor company and its individual manager for alleged securities fraud, and the SEC elected to proceed before an ALJ. Id. at 115, 117-118. The Supreme Court addressed the question “whether the Seventh Amendment permits the SEC to compel respondents to defend themselves before the agency rather than before a jury in federal court,” and concluded that “[t]he Seventh Amendment . . . applies and a jury is required.” Id. at 115, 120-21.

We reject Petitioner’s attempts to equate this case with Jarkesy. This case concerns an entirely separate statutory and regulatory regime administered by the U.S. Department of Health and Human Services, an issue that was not even before the Court, which held that the “SEC’s antifraud provisions replicate common law fraud, and it is well established that common law claims must be heard by a jury.” Jarkesy, 603 U.S. at 120. 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.” Id. at 136. 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 127-132. The Supreme Court did not decide the potential applicability of that exception to the Act and its implementing regulations concerning imposition and enforcement of CMPs for noncompliance with Medicare participation requirements.

As CMS argues, “The Board has consistently held that ALJs may not declare a statute or regulation to be unconstitutional and refuse to apply or follow the statute or regulation on that basis.” Fady Fayad, M.D., DAB No. 2266, at 14 (2009), aff’d, 803 F. Supp. 2d 699 (E.D. Mich. 2011); see also Borgess Med. Ctr., DAB No. 3106, at 42 (2023); Russell L. Reitz, M.D., DAB No. 2748, at 8 (2016). The Board is not authorized to invalidate or declare unconstitutional any part of the Act, or its complex implementing regulations and refuse to enforce it for any reason. Instead, the Board “must follow applicable statutes and regulations,” and we do so in this case. See The Oaks, DAB No. 3160, at 28 (2024); Linda Silva, P.A., DAB No. 2966, at 12 (2019). We cannot anticipate how federal courts may apply the reasoning of Jarkesy in different circumstances, including in the context of the long-standing and complex statutory and regulatory regime governing imposition of

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CMPs upon SNFs, like Petitioner, that CMS deems noncompliant with the conditions of Medicare participation. Accordingly, we deny Petitioner’s motion.

Conclusion

We affirm the ALJ Decision upholding CMS’s determinations that Petitioner was not in substantial compliance with 42 C.F.R. § 483.65, from June 14 through October 5, 2016, at the immediate-jeopardy level. We also affirm the ALJ’s conclusion that the $12,541 CMP imposed for each day during the immediate jeopardy period was reasonable. Finally, we deny Petitioner’s motion for relief based on Jarkesy.

Susan S. Yim²⁷

Endnotes

¹ CMS also alleged violations of 42 C.F.R. §§ 483.20(k)(3)(i), 483.35(i), and 483.70(h)(4), but Petitioner did not challenge them, or the remedy imposed.

² In October 2016, the participation requirements for long-term care facilities in subpart B of Part 483, including the requirements related to infection control, were revised, effective November 28, 2016. Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed Reg. 32,256 (July 13, 2017) (technical corrections). The revision of the infection control requirements was significant, but the ALJ determined that the revision incorporated the pre-revision sections 483.65(a) and (b) into section 483.80(a). See ALJ Decision at 1-2 n.1; 42 C.F.R. § 483.80. The ALJ notified the parties of the plan to use the version in effect in October 2016 and the parties did not object. See ALJ Decision at 1-2 n.1; see also Transcript (Tr.) at 99-100. Like the ALJ, we apply the regulations in effect in October 2016 when the state survey agency conducted the complaint investigation and survey in this case. See Consulate Healthcare of Jacksonville, DAB No. 3119, at 1 n.1 (2023) (citing North Las Vegas Care Ctr., DAB No. 2946, at 1.n.1 (2019)).

³ The version of the SOM in effect at the time of the survey can be found at CMS Ex. 51. Specifically, it calls for all infection prevention and control practices to reflect current CDC guidelines and consistently comply with state and local health department requirements (such as COMAR) for reporting communicable diseases. CMS Ex. 51, at 5, 10. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. See Ind. Dep’t. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); N.W. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).

⁴ Under the regulation, the range of CMPs that CMS may impose is adjusted annually for inflation under 45 C.F.R. Part 102. See 42 C.F.R. § 488.438(a) (Oct. 1, 2016); see also Interim Final Rule, Adjustment for Civil Monetary Penalties for Inflation, 81 Fed. Reg. 61,538, 61,563 (Sept. 6, 2016).

⁵ Our decision, like that of the ALJ, only refers to CDC publications in the record. For all exhibits that are full or excerpted portions of the Guidelines, we refer to the exhibit page numbers rather than the original document’s page numbers.

⁶ QFT-G is a Food and Drug Administration (FDA)-approved blood assay test that provides more accurate results than skin tests and can be used in all circumstances in which the skin test is used, including contact investigations and evaluation of those who had received the Bacille Calmette-Guérin (BCG) vaccination. CMS Ex. 39, at 18. The BCG vaccine is used in most countries where TB disease is endemic. The vaccine is effective in preventing disseminated and meningeal TB disease in infants and young children. It may have approximately 50% efficacy for preventing pulmonary TB disease in adults. See CMS Ex. 41, at 110.

⁷ COMAR section 10.06.01.02(13) defines “health officer” as the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City, or the duly designated representative of the health officer, or both.

⁸ We note that this version of the CDC Guidelines was not the current version. The CDC updated the Guidelines in 2005. See CMS Ex. 41, Guidelines For Preventing The Transmission of Mycobacterium tuberculosis In Health-Care Settings, (MMWR 2005; Vol. 54/No. RR-17).

⁹ “Skin test conversion” is a change in the result of a skin test for TB that is interpreted to indicate a change from being uninfected to infected. A conversion is presumptive evidence of new TB infection and poses an increased risk for progression to active TB disease. See CMS Ex. 40, at 41.

¹⁰ This section is drawn from the ALJ Decision and the record before the ALJ and provides context for the issues Petitioner raises on appeal.

¹¹ P. Ex. 6 contains excerpts from the ICP. This policy and its procedures were mandated by Genesis HealthCare, who managed and operated Petitioner, along with other SNFs across the U.S during the time period at issue. To avoid confusion, we will refer to these as Petitioner’s policy and procedures. See Tr. at 849 (Testimony of Genesis Sr. Vice President of Medical Affairs (Sr. VP of Medical Affairs)).

¹² On May 18, 2015, the county Medical Director notified Petitioner that employee #2 “is currently under my care and is cleared for work.” See CMS Ex. 14, at 35 (emphasis added).

¹³ TB skin testing is interchangeably referred to as PPD and TST. At the time of this contact investigation, the county administered the QFT-G test. See Tr. at 574-575.

¹⁴The ALJ discussed the discrepancies in the number of residents who tested positive during the 2015 testing. See ALJ Decision at 15 n.13. The ALJ ultimately determined that there was no need to resolve the disparate numbers as there were at least 19 residents with positive skin tests and/or QFT-G and negative CXRs and the absence of consistent detailed evidence did not prevent a decision in the case. Id. We agree that discrepancies in the numbers in both the 2015 and 2016 testing does not prevent us from reviewing that decision.

¹⁵ Petitioner’s ICRN testified that R4’s prescribed prophylactic treatment was administered as ordered, beginning in 2015. Tr. at 1061. However, the documentary evidence in the record states R4’s “start date 10/30/15 [INH] 300 mg QD and B6 50 mg QD” and “started INH + Vit 6 10/15 completed 10/3/16.” See P. Ex. 14, at 4-5, 10 (R4’s entire clinical record is not in the record). The ALJ noted entries for prescriptions for INH and vitamin B6 dated June 22, 2016 – but it was not clear from the physician’s order sheet whether the order was new or had been in place since 2015. ALJ Decision at 16; see also CMS Ex. 8, at 29, 31.

¹⁶ There were two different complaints filed, only one of which dealt with the occurrence of TB in the facility. See CMS Ex. 23. No aspects of the other complaint are part of this appeal.

¹⁷ The notice does not indicate what the modifications were, but a comparison of the text in the original SOD and the version attached to the IDR report reveals the last paragraph of the original text was removed. It stated, “There is no documented evidence that the facility reached out to the local health department/CD&E/TB staff, except as indicated during some of the monthly Quality Assurance meeting documentation when ‘waiting for the local health department follow up.’” Compare CMS Ex. 1, at 14–15 with CMS Ex. 36, at 14.

¹⁸ The RFH indicates that Petitioner requested Independent Informal Dispute Resolution (IIDR) to contest the cited deficiency, which was pending as of the date of the RFH, but further stated that if the IIDR process causes CMS to withdraw the CMP at issue, Petitioner would dismiss the appeal. RFH at 2. The record does not contain that request, but it does contain the result of the IIDR, issued on March 29, 2017, substantiating the citation but indicating the reviewer determined that August 4, 2016, should be the start date for the immediate jeopardy determination. CMS Ex. 13, at 1, 14.

¹⁹ As the ALJ noted, CMS determined that Petitioner returned to substantial compliance effective December 12, 2016, thus ending the accrual of the CMP effective December 11, 2016. ALJ Decision at 3 n.2. Thus, as the ALJ also noted, “[t]he parties incorrectly stipulated that the CMP . . . ran through December 12, 2016.” Id.

²⁰ As Petitioner did not request review of the noncompliance cited as violations of 42 C.F.R. §§ 483.20(k)(3)(i), 483.35(i), and 483.70(h)(4), or the $303 per day CMP associated with those citations, the ALJ made two additional conclusions of law, finding those citations and the associated CMP administratively final, and that the $303 per day CMP is not subject to further review for reasonableness. ALJ Decision at 9.

²¹ Petitioner’s argument relies on the proposition that the only basis for noncompliance could be the county sending treatment orders in 2015, and Petitioner receiving, but not implementing, those orders. Without that, it asserts that any basis for noncompliance is dependent on an ad hoc regulatory obligation. The ALJ found credible evidence that the county “sent treatment recommendations to Petitioner’s medical director. However, there is also credible evidence, sufficient to overcome any presumption of receipt, that the treatment recommendations were not received.” ALJ Decision at 39. The ALJ’s determination of noncompliance did not turn on whether Petitioner ever received treatment recommendations from the county, concluding that receipt or non-receipt of recommendations was immaterial; Petitioner would be no less liable for failure to follow its infection control policy in either case. Id. at 39-40; see also n.21.

²² As the ALJ relied on evidence other than the surveyor’s testimony or related observations in the SOD, and made credibility determinations on all the witnesses, we need not address the conflict argument any further. See Avon Nursing Home, DAB No. 2830, at 11-12 (2017) citing Sunshine Haven Lordsburg, DAB No. 2456, at 21 (2012), aff’d in part and transferred, Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs., 742 F.3d 1239 (10th Cir. 2014) (noting that the ultimate issue is not whether the survey was performed correctly but whether “the evidence as it is developed before the ALJ supports” CMS’s independent “finding of non-compliance” under the relevant participation requirements) (internal quotation marks omitted); see also Lifehouse of Riverside Healthcare Ctr., DAB No. 2774, at 13 (2017); Blossom South Nursing & Rehab. Ctr., DAB No. 2578, at 19 (2014) (the Board defers to ALJ findings on weight and credibility of witness testimony absent a compelling reason to do otherwise); see, e.g., Woodland Oaks Healthcare Facility, DAB No. 2355, at 7 (2010). Petitioner has shown no such clear error or other compelling reason here.

²³ The ALJ expressly indicated that alternative theories of liability offered by CMS at the hearing and in post-hearing briefs were not considered in concluding Petitioner was noncompliant with section 483.65. See ALJ Decision at 39.

²⁴ The ALJ noted that the quality-of-care requirements of 42 C.F.R. § 483.25 were revised effective November 28, 2016, but the regulation number and the requirement to ensure that residents received necessary care and services were unchanged. ALJ Decision at 46 n.26 (citing 81 Fed. Reg. 68,688, 68,745). Later in the decision, the ALJ further indicated that “I recognize that CMS did not charge Petitioner for either failure to deliver necessary care and service or neglect. I consider only the practical effect of Petitioner’s action.” See id. at 60 n.31. Petitioner has not challenged the ALJ’s reference to, or analysis of, 42 C.F.R. § 483.25 on appeal. While CMS did not cite any violation of section 483.25, there is no dispute that section 483.65 imposes on a SNF the responsibility to identify and adopt as policy – and then meet – adequate infection control standards. The Board has found that to read the regulation in any other way “would undercut Congressional intent to ensure quality of care in nursing facilities, since professional standards may change over time.” See Golden Living Ctr. – Superior, DAB No. 2768, at 23 (2017). The Board further stated, “our understanding and application of section 483.65 here comports with other Board decisions which hold that a SNF’s resident care policies may, in appropriate circumstances, be used to judge whether the SNF has complied with Part 483 regulations that impose general quality-of-care obligations.” Id. (emphasis added) (citing Omni Manor Nursing Home, DAB No. 1920, at 23 (2004); cf. John J. Kane Reg’l Ctr. – Glen Hazel, DAB No. 2068, at 12 (2007) (noting that the requirement under section 483.25 to provide “necessary care and services” implies an obligation to ensure that services meet “professional standards of quality” not specified in that regulation). We focus our review on the cited deficiency of section 483.65, but do so with the understanding that infection control is a distinct quality of care obligation which Petitioner is obligated to provide to “protect the health and safety of its residents who are the intended beneficiaries of the [Medicare] program”. See Sanctuary at Whispering Meadows, DAB No. 1925, at 9 (2004), aff’d, 151 F. App’x 386 (6th Cir. Oct. 7, 2005).

²⁵ We note that because the Maryland Guidelines and COMAR required the county to provide recommended treatment for LTBI, Petitioner would not have had to request the county do so. The record established that neither the county witnesses who testified, nor the surveyor, were aware of that requirement. We infer that Petitioner became aware of this requirement after the survey and IDR. See Tr. at 192, 492; 511, 575-576, 999-1000; cf Tr. at 8. This is not dispositive to our review but provides useful context to the seemingly inconsistent evidence prior to, and after, the request for ALJ review.

²⁶ PRN staff are healthcare professionals who work “as circumstances may require.” COMAR § 10.07.02.01.B(40) (2017).

²⁷ Former Board Member Susan S. Yim fully participated in all deliberations concerning this matter and, before her retirement, reached consensus with the Board on the final decision and reviewed and approved it.