Sligo Creek Center, DAB CR5745 (2020)

DECISION

Petitioner, Sligo Creek Center, was not in substantial compliance with program participation requirements from June 14 through December 11, 2016, due to violations of multiple participation requirements established by 42 C.F.R. pt. 483.1  There is a basis for

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the imposition of enforcement remedies.  The following enforcement remedy is reasonable:  a $12,541 per-day civil money penalty (CMP) from June 14 through October 5, 2016, and a $303 per-day CMP from October 6 through December 11, 2016, for a total CMP of $1,449,975.

I.  Background

Petitioner is located in Takoma Park, Maryland, and participates in Medicare as a skilled nursing facility (SNF) and the state Medicaid program as a nursing facility (NF).  Joint Settlement Status Report, Joint Stipulations of Undisputed Facts (Jt. Stip.)  ¶ 1, and Joint Statement of Issues Presented for Hearing.  On September 27 and 28, and October 6, 2016, the Montgomery County, Maryland Department of Health and Human Services (state agency) completed a survey of Petitioner that was triggered by a complaint.  The state agency found Petitioner was not in substantial compliance with program participation requirements.  CMS Exs. 1, 19 at 1-34; Jt. Stip. ¶ 2.  On December 12, 2016, the state agency conducted a revisit survey and concluded that Petitioner had

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returned to substantial compliance effective that day.2  CMS Ex. 19 at 35-44; CMS Ex. 20 at 2.  CMS notified Petitioner by letter dated January 31, 2017, that it was imposing the following enforcement remedy:  a $12,541 per-day CMP from June 14 through October 5, 2016, and a $303 per-day CMP from October 6 through December 11, 2016.  CMS Ex. 20 at 1-5.

Petitioner requested a hearing before an administrative law judge (ALJ) on March 20, 2017 (RFH).  The case was assigned to me for hearing and decision on March 24, 2017, and an Acknowledgment and Prehearing Order was issued at my direction.

On July 16 through 18, 2018, a hearing was convened by video teleconference and a transcript (Tr.) of the proceedings was prepared.  CMS offered CMS exhibits (CMS Exs.) 1 through 50, and CMS Exs. 1 through 47, 49, and 50 were admitted as evidence.  Tr. 56-70, 306-07.  CMS withdrew its offer of CMS Ex. 48, which remains in the record but is not considered substantive evidence.  Tr. 210-15.  CMS offered CMS Exs. 51, 52, and 53 post-hearing per agreement of the parties at hearing, and they are admitted.  Tr. 1096-98.  Petitioner offered Petitioner exhibits (P. Exs.) 1 through 31 that were admitted as evidence.  Tr. 70-94, 944, 997, 1103.

CMS called the following witnesses to testify:  Surveyor Raphaella Slade, RN; Kimberly Townsend, MPA, BSN, RN; and Itala Fontana, RN.  The parties agreed to preserve the testimony of Sapna Bamrah Morris MD, MBA, CMS's expert witness, by deposition prior to hearing because she was unable to attend the hearing.  Dr. Morris's declarations were admitted as CMS Exs. 42 and 46 and her deposition testimony as CMS Ex. 49.

Petitioner called the following witnesses:  John Loome, MD; Funmi Odunubi, RN, Petitioner's director of nursing (DON); Suzanne Hayden, RN, Petitioner's Assistant DON (ADON) and infection control nurse; Bret Stine, Petitioner's administrator from approximately March to July 2015; Eduardo Salazar, Petitioner's administrator beginning in July 2015 for approximately two years; and Richard Hodder, MD.  Following the hearing, the parties filed post-hearing briefs (CMS Br. and P. Br., respectively) and post-hearing replies (CMS Reply and P. Reply, respectively).

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II.  Discussion

A.  Issues

Whether there is a basis for the imposition of an enforcement remedy;

Whether the declaration of immediate jeopardy is clearly erroneous; and

Whether the remedy imposed is reasonable.

B.  Applicable Law

The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and at 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.3  The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of the date noncompliance began.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF, if the SNF fails to return to substantial compliance with program participation requirements within three months of the date noncompliance began – commonly referred to as the mandatory or statutory denial of payment for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF's participation in Medicare, even if there has been less than 180 days of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, CMPs, appointment of temporary management, and other remedies such as a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements.  "Substantial compliance means a level of compliance with

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the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm."  42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary's regulations at 42 C.F.R. pt. 483, subpt. B.  Noncompliance refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance, i.e., a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10-.28, 488.300-.335.  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  The regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  The upper range of a CMP, $6,291 per day to $20,628 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.4  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table).  "Immediate jeopardy means 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 (emphasis in original).  The lower range of CMPs, $103 per day to $6,188 per day, is reserved for deficiencies that do not pose immediate jeopardy, but either cause actual harm to residents, or cause no actual harm but have the potential for causing more than minimal harm.  42 C.F.R. § 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (Table).

The Act and regulations make a hearing before an ALJ available to a long-term care facility against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy."  42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of enforcement remedies or the factors CMS considered when choosing enforcement remedies are not

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subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility's authority to conduct a nurse aide training and competency evaluation program (NATCEP).  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  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); Woodstock Care Ctr., DAB No. 1726 at 9, 38 (2000), aff'd, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000).  ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

The hearing before an ALJ is a de novo proceeding, that is, "a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies."  Life Care Ctr. of Bardstown, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of persuasion and the quantum of evidence required to meet the burden is not addressed by regulations.5  Rather, the Board has long held that the petitioner, the nongovernmental party, bears the burden of persuasion to show by a

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preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  Batavia Nursing & Convalescent Inn, DAB No. 1911 (2004); Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App'x 181 (6th Cir. 2005); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Ctr., DAB No. 1665 (1998); Hillman Rehab. Ctr., DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), aff'd, Hillman Rehab. Ctr. v. United States, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that only when CMS makes a prima facie showing of noncompliance, is the facility burdened to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The Board has not specified how much evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with "evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement."  Id.; Batavia Nursing & Convalescent Ctr., DAB No. 1904.  "Prima facie" means generally that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted."  Black's Law Dictionary 1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, that is, CMS should be burdened to present evidence sufficient to establish a fact as more likely true and to raise a presumption.  However, the Board has never ruled that CMS must establish its prima facie case by a preponderance of the evidence.  Indeed, it is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.  In this case, I conclude that CMS has made its prima facie showing by a preponderance of the evidence.

C.  Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence given the greatest weight in my decision-making.6  I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible

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evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., Admin. L. and Prac. § 5:64 (3d ed. 2013).

CMS alleges based upon the survey that ended October 6, 2016, that Petitioner was not in substantial compliance with program participation requirements from June 14, 2016 through December 11, 2016, based upon violations of 42 C.F.R. §§ 483.20(k)(3)(i) (Tag F281,7 scope and severity (s/s) D8); 483.35(i) (Tag F371, s/s E); 483.65 (Tag F441, s/s K); and 483.70(h)(4) (Tag F469, s/s E).

Petitioner requested ALJ review of only the noncompliance cited as posing immediate jeopardy based on the alleged violation of 42 C.F.R. § 483.65 (Tag F441).  RFH; Tr. 14-15.  Accordingly, my review is limited to the alleged noncompliance under Tag F441 and

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the reasonableness of the CMP in the upper range of authorized CMPs based on the immediate jeopardy citation.

1.  Petitioner did not request review of the noncompliance cited as violations of 42 C.F.R. §§ 483.20(k)(3)(i) (Tag F281) (s/s D), 483.35(i) (Tag F371) (s/s E), and 483.70(h)(4) (Tag F469) (s/s E); those citations of noncompliance are administratively final; and the citations are bases for the imposition of enforcement remedies.

2.  Petitioner did not request review of the reasonableness of the $303 per day CMP based on the unchallenged noncompliance citations for the period October 6 through December 11, 2016, and that remedy is administratively final and not subject to further review for reasonableness.

3.  CMS has established a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. § 483.65.

4.  Petitioner has not met its burden to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. § 483.65 during the period June 14 through December 11, 2016.

a.  Facts

This case involves the occurrence of Tuberculosis (TB) in Petitioner's facility.  Findings related to latent TB infection (latent TB infection) and active TB are set forth followed by findings of fact regarding the occurrence of TB in Petitioner's facility.

i.  Latent TB Infection, Active TB, and Standard of Care

Centers for Disease Control and Prevention (CDC) Guidelines

The CDC issues recommendations and guidelines for controlling tuberculosis in the United States.  In 2005, the CDC published a revision of its guidelines previously published in 1994, for preventing the transmission of TB in health-care settings.  CMS Ex. 41 at 3.  In 2005, the CDC also issued with the American Thoracic Society and the Infectious Diseases Society of America recommendations for controlling tuberculosis in the United States.  CMS Ex. 53.  The CDC is accepted as an authoritative and credible

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source for information on the cause and control of TB and its guidance is evidence of the standard of care.9

TB is an infectious disease that is caused by the bacterium Mycobacterium tuberculosis (M. tuberculosis).  According to the CDC, M. tuberculosis, which is carried in airborne droplets, 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 one tests positive when tested for TB.  The CDC says that the probability for infection from M. tuberculosis is affected by the concentration of droplets carrying M. tuberculosis and the duration of exposure – the closer the proximity to one infected and the longer the exposure, the higher the risk for infection.  CMS Exs. 41 at 6, 115-16; 42 at 2-3; 53 at 9.   M. tuberculosis can attack any part of the body but generally attacks the lungs.  There are two TB-related conditions, latent TB infection and TB disease also referred to as active TB.  If not treated properly active TB can be fatal, and five percent of patients diagnosed in the United States each year with active TB are either dead when diagnosed or they die during treatment.  CMS Ex. 42 at 2-3, 5.  Active TB in the throat or lungs can be infectious while active TB in other parts of the body are generally not.  Active TB is most likely to be spread among people who spend time together every day.  CMS Ex. 42 at 3.  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.  The CDC stresses that the treatment of latent TB infection is essential to control and eliminate TB because it substantially reduces the risk that M. tuberculosis will progress to active TB.  CMS Ex. 41 at 55.

The following definitions from CDC guidance are important in this case:

Latent TB infection, often referred to as LTBI, is a condition in which a person is infected with M. tuberculosis but does not have active TB.  People with latent TB infection are asymptomatic, do not feel sick, have a positive TB test but a negative chest x-ray for active TB, and do not transmit the disease.  People with latent TB infection are at risk for progression to active disease.  Treatment (referred to as preventative therapy, chemoprophylaxis, or prophylaxis) is indicated for those at risk for progression to active TB.

Active TB means that the disease caused by M. tuberculosis is clinically active.

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Infectious TB refers to active TB of the lungs or larynx.  People with infectious TB have the potential to transmit the disease.

CMS Exs. 30 at 10; 41 at 46; 42 at 3-4; 49 at 126-29; 53 at 4, 12.

Persons at high risk for progression from latent TB infection to active TB include people infected with M. tuberculosis within the previous two years.  CMS Exs. 41 at 7; 42 at 3; 53 at 12.  It is not disputed that progression from latent TB infection to active TB can occur at any time after being infected.  CMS Ex. 42 at 15.  According to the CDC, approximately five percent of people with newly acquired latent TB infection progress to active TB within two years of exposure, if there is no intervention.  CMS Ex. 53 at 37.  Approximately five to 10 percent of people with latent TB infection who are not treated will develop active TB during their lifetime.  CMS Exs. 30 at 7; 41 at 6; 42 at 3.  The CDC says that people with latent TB infection should be treated absent compelling contraindications.  Treating latent TB infection is easier than treating active TB and helps prevent the spread of TB.  CMS Ex. 42 at 4, 6.  The CDC recommends that directly observed therapy (i.e., a healthcare worker watches the swallowing of each dose and records administration) be used when possible.  CMS Exs. 53 at 40; 41 at 8-9, 21.  According to the CDC, directly observed therapy is the standard of care for treating active TB or latent TB infection.  CMS Ex. 41 at 21, 56-57.

CDC recommendations for TB control in health care facilities include offering treatment, if not contraindicated, for residents with latent TB infection.  CMS Ex. 53 at 60, 70.  Health care facilities pose an increased risk for transmission of TB due to the congregate setting.  CMS Exs. 30 at 9; 41 at 7, 29; 42 at 11; 53 at 17.  Therefore, residents in SNFs and NFs are at increased risk for transmission of TB.  According to the CDC, elderly residents in SNFs and NFs "are almost twice as likely to acquire TB as those living in the community."  CMS Ex. 53 at 60.  The CDC recommends that nursing home residents with latent TB infection "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.  The CDC notes that there is evidence of the value of treating latent TB infection in elderly residents of nursing homes to prevent future outbreaks.  CMS Exs. 41 at 86; 53 at 60, 70.  There is evidence that treatment of latent TB infection can reduce the risk for death due to progression to active TB.  CMS Exs. 32 at 5-6; 33 at 6.

CDC recommended strategies for controlling TB in the United States include identification of people with latent TB infection that are at risk for progression to active TB and treatment with an effective drug regime.  CMS Exs. 30 at 8; 53 at 17.  The preferred treatment for latent TB infection is nine months of isoniazid (INH), but other

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treatment regimens are characterized as acceptable alternatives.  CMS Exs. 30 at 18; 41 at 55, 86.

The CDC states that by law suspected or confirmed TB in a patient or health care worker must be reported to the local or state health department "so that follow up can be arranged and a community contact investigation can be conducted."  CMS Ex. 41 at 38, 58.  The CDC states that 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 Exs. 42 at 8; 53 at 22.  According to the CDC, "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; 10 P. Ex. 5 at 1-2.

Maryland Regulations and Guidelines

The Maryland Department of Health and Mental Hygiene issued the "Maryland TB Guidelines for Prevention and Treatment of Tuberculosis" in 2007.  CMS Ex. 39.  The Maryland state health department is accepted as a credible source, and its guidance is also evidence of the standard of care.  Listed as a general objective in the Maryland guidelines, among others, is the provision of treatment for latent TB infection to "high-risk reactors."  CMS Ex. 39 at 10.  The Maryland guidelines provide that 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 TB.  The policy provides 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.  CMS Ex. 39 at 10.  Therefore, the Maryland guidance specifically recognizes the role of a private provider in treating one with TB.  The Maryland guidelines recognize that residents of SNFs/NFs are at risk for infection and the recently infected are at risk for conversion from latent TB infection to active TB.  The guidelines state that a decision to test for TB is a decision to treat, including recent contacts with TB infection and residents of SNFs/NFs.  CMS Ex. 39 at 12-14.  The purpose of treating latent TB infection is to reduce the chance a person with latent TB progresses to active TB.  Treatment should be targeted to high-risk groups regardless of age, including the recently infected and those in SNFs/NFs.  CMS Ex. 39 at 14, 19.

Maryland specifies that directly observed therapy is the standard of care for active TB.  The Maryland guidelines do not specify that directly observed therapy is the standard of care for latent TB infection.  Maryland specifies either INH or rifampin is used for

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treatment of latent TB infection for six or nine months depending on the treatment regime.  CMS Ex. 39 at 20-21, 28-30, 59.  Compliance with diagnosis, treatment, and quarantine is enforceable by law in Maryland.  CMS Ex. 39 at 39.

Maryland regulations applicable to Petitioner require that the facility medical director serve as a liaison with local health officials and public health agencies.  CMS Ex. 38 at 10, 14 (Md. Code Regs. 10.07.20.11-1(G)(3)).  Maryland regulations also require that a facility monitor residents for signs and symptoms of tuberculosis by performing an annual symptom review, and if signs and symptoms are detected, a physician is required to evaluate for TB in communicable form, notify the health officer within 24 hours if the physician suspects TB, and coordinate management of the resident and the resident's contacts with the health officer.  The regulations require that the facility assess and manage a resident with possible TB in accordance with CDC guidelines.  CMS Ex. 38 at 17 (Md. Code Regs. 10.07.02.21-2(b)(4)-(5)).  In Maryland, a health officer is required to recommend appropriate treatment for latent TB infection.  CMS Ex. 38 at 19 (Md. Code Regs. 10.06.01.21(B)(2)).

ii.  TB in Petitioner's Staff and Residents

2015 TB Outbreak11 and Contact Investigation12

The parties proposed findings of fact and the evidence admitted shows that there is little dispute regarding the outbreak of active TB and latent TB infection in Petitioner's facility among staff and residents.  I note that there is a dispute about whether Petitioner's medical director, Dr. Passi, or Petitioner's staff ever received recommendations or orders for treatment of latent TB infection identified in its residents from the county health

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department between the revelation of the outbreak in May 2015 and September 2016.  I find based on the following summary of the evidence that no recommendations for treatment of latent TB infection were received by Petitioner from the county health department prior to September 2016.  P. Exs. 26-27.

On about March 10, 2015, Petitioner's administrator, Bret Stine, received a letter from the county health department informing him that a housekeeper, referred to as RC, was not cleared to work until further notice.  Petitioner's Proposed Findings of Fact (PPFF) ¶¶ 62, 64; CMS' Proposed Findings of Fact (CPFF) ¶ 14; P. Ex. 1; CMS Ex. 14 at 34; Tr. 981.  The letter did not reveal that employee RC had active TB, but Petitioner learned that fact about two months later, which would be sometime in May 2015.  PPFF ¶ 66; CPFF ¶ 15; CMS Ex. 14 at 36; Tr. 982.  The case of RC is referred to as an index case by the experts and parties.

On April 27, 2015, Petitioner learned that a second staff member, nursing assistant MA, was being treated for active TB.  The county health department did not formally notify Petitioner of this second active case until May 2015.  PPFF ¶¶ 68, 69; CPFF ¶ 16; CMS Ex. 14 at 37.

On about May 13, 2015, the county health department notified Petitioner that a resident who had been hospitalized and died a week or so earlier had had active TB.  PPFF ¶ 78; CPFF ¶¶ 23, 24; Tr. 987-92.

Therefore, there is no dispute that in May 2015, Petitioner's management knew it had two employees infected with active TB and that a recently deceased resident had had active TB.

On May 15, 2015, county health department officials met with Petitioner's administrator Stine, DON Odunubi, medical director Dr. Passi, ADON Hayden, the medical director and regional vice president for Petitioner's operator Dr. Loome (May 15, 2015 meeting).  PPFF ¶ 79; CPFF ¶¶ 24-26; P. Ex. 7.  Petitioner's staff understood that the county health department officials stated that they would take the lead and guide Petitioner's response.  The county health department officials informed Petitioner that all residents potentially exposed to TB from January to March 2015, should be tested for TB exposure.  PPFF ¶ 84; Tr. 469-475, 478-79, 945-48.  Petitioner was responsible to ensure all residents were tested.  PPFF ¶ 85; CPFF ¶ 25; Tr. 994-96.

ADON Hayden testified that she understood from the discussion at the May 15, 2015 meeting, that Petitioner would be providing medications for treatment of residents with latent TB infection, but the specific medications to be provided were not discussed.  She also understood that the county health department would provide specific directions, assist to complete testing, and recommend necessary medication for treatment of latent TB infection.  PPFF ¶¶ 85-86; Tr. 996-1001.

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Following the May 15, 2015 meeting, Petitioner's staff completed two rounds of testing for all residents not previously tested positive for TB exposure.  Testing, which I infer was skin testing as the evidence shows that the county health department did the blood testing for residents for whom skin tests were contraindicated, showed 19 or 2013 residents with TB exposure, and a list was provided to the county health department.  Chest x-rays showed that none of the residents had active TB at the time.  The second round of testing, which I infer was both skin testing by Petitioner's staff and blood testing by the county health department, was completed in August 2015, except for blood tests for four foreign born residents.  PPFF ¶¶ 94, 99, 103-104, 116-20; CPFF ¶¶ 29-31, 33-35, 39; CMS Ex. 22 at 16-21; Tr. 1001-1022.

There is no dispute that a decision was made to delay prophylactic treatment of the latent TB infection cases until after the second round of testing of Petitioner's residents was completed.  Both the county health department and Petitioner's staff were aware of and agreed with that decision.  Tr. 585-87, 633-34, 1065; PPFF ¶ 111; CPFF ¶ 32.

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Resident 4's Treatment for Latent TB Infection

The evidence shows Resident 4 tested positive for TB on about May 25, 2015, and an x-ray was negative for active TB.  CMS Ex. 8 at 15, 19, 36-37.  "Symptom Surveillance for Tuberculosis" forms electronically signed by DON Odunubi direct annual monitoring only for Resident 4.  CMS Ex. 8 at 38-39.  Resident 4 tested positive again in October 2015, during preparation for a kidney transplant, and her physician ordered prophylactic medication that was administered by Petitioner's staff.  PPFF ¶ 121-123; CPFF ¶ 40; CMS Exs. 14 at 129; 28 at 2; P. Ex. 20.  On November 5, 2015, ADON Hayden sent a facsimile to the county health department.  Written on the facsimile cover sheet is information that Resident 4 was started on INH 300 mg per day and vitamin B-6 50 mg once per day.  A progress note that was transmitted with the facsimile cover-sheet is dated October 28, 2015, and shows that Resident 4 was seen by an infectious disease physician due to testing positive for TB that was not active and he prescribed INH and vitamin B-6 on October 28, 2015.  P. Ex. 20 at 1-2; Tr. 1059-60.  There is no documentary evidence offered by either party that Resident 4 received INH beginning in October 2015.  However, ADON Hayden testified the medication was administered as ordered.  Tr. 1061.  Clinical records for Resident 4 obtained by the surveyors show that on June 22, 2016, Resident 4 had a prescription for INH 300 mg, one time per day for latent TB infection.  CMS Ex. 8 at 4, 29.  It is not clear from the Physician's Order sheet whether the order was a new order or had been in place since October or November 2015.  Resident 4 was again tested for TB on August 30, 2016, and it was reported that there was no evidence of TB.  CMS Ex. 8 at 21, 22, 40-45.

Other Residents with Latent TB Infection Were Not Treated

There is no dispute that no prophylactic treatment was started in 2015 or before September 2016 for any resident that tested positive for latent TB infection, except for Resident 4.  Petitioner knew that no treatments for latent TB infection were provided to its residents who tested positive for latent TB throughout 2015 and until September 2016, except Resident 4.  PPFF ¶¶ 132, 134, 135, 137, 139, 158; CPFF ¶ 40-41.

TB testing and the administration of prophylactic medication for latent TB infection was regularly discussed among Petitioner's staff and management from August 2015 through January 2016, and after.  PPFF ¶¶ 125, 128-30; CPFF ¶¶ 43-47.

In May 2016, Petitioner's staff did an annual assessment of residents who had previously tested positive for exposure to TB in 2015, and staff found no signs or symptoms of active TB.  PPFF ¶ 163; P. Ex. 21.

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Resident 1's Conversion14 to Active TB and the 2016 TB Outbreak

Resident 1 tested positive for TB in May 2015, and a chest x-ray showed no active TB.  PPFF ¶ 166; CPFF ¶ 50; CMS Ex. 5 at 29-30, 36, 77, 79, 87-88; Tr. 1025-26.  Symptom Surveillance for TB forms indicate that effective May 9, 2015, the resident was on annual monitoring only.  CMS Ex. 5 at 44-45.  A year later, on June 4, 2016, Resident 1 had a chest x-ray.  PPFF ¶¶ 170-176; CPFF ¶ 51; CMS Ex. 5 at 61.  However, Resident 1's physician did not diagnose Resident 1 with active TB.  PPFF ¶¶ 177-180; CMS Ex. 5 at 55-58, 62-72.  On August 4, 2016, Resident 1 was coughing up blood.  PPFF ¶ 182; CPFF ¶ 53; CMS Ex. 5 at 2.  Resident 1's clinical records in evidence do not list a diagnosis of latent TB infection.  Tr. 143-44.  However, her records from May 29, 2015, do reflect a positive test for TB followed by a chest x-ray.  CMS Ex. 5 at 29.  On August 9, 2016, another chest x-ray resulted in the diagnosis of active TB.  PPFF ¶¶ 182-183; CPFF ¶ 55; CMS Ex. 5 at 43, 46-48.

Due to Resident 1's diagnosis with active TB, Petitioner's staff contacted the county health department and testing of all employees and residents of Petitioner's facility began again.  PPFF ¶ 184.  Following the new testing, which was completed in September 2016, 16 residents were identified as having latent TB infection (including some that were positive in 2015), no active TB was identified, and prophylactic treatment was recommended or ordered beginning about September 15, 2016.  PPFF ¶¶ 185-187; P. Exs. 22-27; CMS Ex. 14 at 236-42; Tr. 1069-70.

Active TB of Employee in 2015 and Active TB of Resident 1 Had Common Origin

The Maryland Department of Health and Mental Hygiene, at the request of counsel for CMS, compared a sample taken from housekeeper RC on March 10, 2015, and a sample from Resident 1 obtained August 9, 2016.  The genotype matched indicating that there was likely a common origin for the TB.  CMS Exs. 39 at 27; 46 at 4-6; 47; 53 at 14-16.

Petitioner's TB Management Policy

Petitioner was not cited by the surveyor for not having an infection control policy and procedure as required by 42 C.F.R. § 483.65.  There is no dispute that Petitioner had the required policy, extracts of which specifically related to TB are in evidence marked as P. Ex. 6.

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Petitioner's tuberculosis management policy shows it became effective September 1, 2004, it was revised on October 1, 2013, and it was subsequently reviewed on September 1, 2015.  P. Ex. 6 at 1.  There is no dispute that this policy and procedure document was in effect in 2015 and 2016 during the TB outbreaks at Petitioner's facility.  The document placed in evidence is composed of a policy statement (P. Ex. 6 at 1-2) followed by a procedure for TB screening (P. Ex. 6 at 3-5), and a separate procedure for addressing TB post exposure for residents (P. Ex. 6 at 6-7).

The policy statement provides that all residents are tested for TB on admission to Petitioner in accordance with CDC guidelines and Maryland law and recommendations.  The policy statement provides that if TB exposure occurs in Petitioner's facility, management is to notify the health department and conduct an investigation in accordance with state guidelines.  The policy provides that all residents are to be screened in accordance with state guidelines.  The stated purpose of the policy is to reduce the risk for transmission of TB among residents and provide management if TB exposure occurs.  P. Ex. 6 at 1.  The policy sets forth practice standards in sections titled "screening" and "post exposure."  The policy clearly addresses:  (1) routine screening testing upon admission to Petitioner; and (2) the action required when it is determined that a resident has been identified as having been exposed to TB.  The policy provides that when TB is identified (the policy does not specify active TB or latent TB infection) the health department is to be notified and its recommendations for investigation and follow-up are to be followed; an investigation is to be done to identify any residents or staff that have been exposed; and treatment needs of residents are to be determined.  P. Ex. 6 at 1-2.  I note that Petitioner's policy does not state that investigation and determination of treatment needs are to be accomplished by the health department, or suggest that Petitioner's staff must wait for those steps to be completed by the county health department.

Petitioner's TB screening procedure requires staff to review any hospital discharge summary of a resident being admitted to Petitioner for signs of TB.  P. Ex. 6 at 3.  I consider this requirement to reflect Petitioner's recognition that is important to clearly document in clinical records any evidence of TB, which could include active TB, or the results of testing reflecting latent TB infection.  The procedure requires skin testing within 48 hours and within no more than 10 days for all new admissions, except in specified cases.  The procedure specifies that for new admissions a first skin test is to be done and if it is negative a second test is to be done in one to three weeks.  The policy specifies that if either skin test is positive, staff is to obtain a chest x-ray and medical evaluation is to be done.  Staff is also instructed to observe for signs and symptoms of TB and obtain medical evaluations if signs and symptoms are present.  If a resident is identified as having suspected or confirmed TB, steps to isolate and transfer the resident are specified.  If the required chest x-ray is negative for active disease the procedure requires that:  (1) symptoms of active TB are to be reviewed with the resident and the resident is to be monitored annually; (2) the resident is to report any signs or symptoms

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of active TB; and (3) staff is to observe for signs and symptoms of TB, which I construe, based on the CDC material described, to be active TB as latent TB infection appears to have no observable signs and symptoms, other than a positive skin test and negative chest x-ray.  In section 4 of the procedure, it is specified if at any time a resident develops signs and symptoms of TB, which arguably should include a positive skin test, staff is to obtain a chest x-ray and initiate medical evaluation.  If the chest x-ray and/or medical evaluation is negative for active disease, alternative diagnoses are to be considered and the resident evaluated for chemoprophylaxis, which I construe to be treatment for latent TB infection.  P. Ex. 6 at 3-4.  Petitioner's TB screening procedure does not state that testing, medical evaluation, and determination of whether treatment is appropriate are to be accomplished by the health department, or suggest that Petitioner's staff must wait for those steps to be completed by the county health department.  P. Ex. 6 at 3-5.

Petitioner's post TB exposure procedure for residents provides that as soon as TB exposure is identified (no distinction is made between active TB and latent TB infection), the health department is to be notified and its recommendations for investigation and follow-up are to be followed.  P. Ex. 6 at 6.  The procedure requires staff to investigate and to identify any residents or staff who have been exposed to TB.  The procedure requires that skin testing, except in specified cases, proceed, ideally with two weeks of possible TB exposure.  If the results of the first skin test are negative, a second test is done within 12 weeks after exposure.  If a skin test is positive, the procedure is to obtain a chest x-ray and medical evaluation.  Although the organization of sections of the procedure is confusing, the procedure specifies that when a chest x-ray and/or medical evaluation is negative for active disease, staff is to proceed to obtain an evaluation for chemoprophylaxis.  P. Ex. 6 at 5-7.  Petitioner's procedure does not state that staff is to wait to follow the procedure, including skin testing, chest x-rays, medical evaluation, and evaluation for treatment of latent TB infection, until the health department makes its recommendations for investigation and follow-up.

Petitioner's infection control policy and procedures related to TB do not specifically mention notification of a resident's treating physician, but I find it more likely than not that the medical evaluations and evaluations for chemoprophylaxis should be read to suggest that those evaluations include the treating physician.  The policy and procedures clearly do not state that a medical evaluation or evaluation for prophylaxis was to be performed by county health department officials.  The policy and procedures clearly direct facility staff to obtain the evaluations and the most likely source for such an evaluation would be the resident's treating physician.

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Witness Testimony15

Kimberly Townsend, MPA, BSN, RN was called by CMS and testified by declaration subject to cross-examination at hearing.  RN Townsend was a nurse administrator for the county health department.  She testified regarding the meeting she and RN Fontana attended with Petitioner's staff in May 2015.  She testified the purpose of the meeting was to provide Petitioner's staff direction regarding a contact investigation following possible exposure of staff and residents to active TB.  She testified that it was explained to Petitioner's staff that staff members had the option of obtaining TB testing from the county health department or their own primary physician, but Petitioner was responsible for care and treatment of its residents, including testing and follow-up treatment.  She testified that it was agreed that Petitioner would handle most testing, but Petitioner's staff requested assistance with obtaining blood testing.  RN Townsend testified it was explained to Petitioner's staff that the goal was identification and treatment of individuals with active TB and those with latent TB infection.  She testified that it was explained that the county health department recommended prophylactic treatment for anyone who had a positive TB test and treatment would be provided by Petitioner.  Monitoring of affected residents was also emphasized.  She testified that Petitioner's staff verbalized agreement and understanding.  CMS Ex. 44; Tr. 472-74, 478-80, 490-91.  RN Townsend testified that she and RN Fontana had a conference call with Petitioner's medical director at the time, Dr. Passi, probably in May 2015.  During the conference call, treatment for latent TB infection was discussed and she believed he understood that isoniazid (INH) and vitamin B6 were usually used for nine months.  Tr. 526-29.  RN Townsend testified that under Maryland law the county health department was only responsible for oversight of active TB cases not cases of latent TB infection.  She testified that the occurrence of latent TB infection is not something that must be reported to the county health

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department and only active TB cases are reportable.  Tr. 515-16.  RN Townsend's testimony regarding the county health department's involvement with latent TB infection cases is at odds with the Maryland guidance and regulations, and is not accepted as weighty.

RN Townsend testified that the county health department took the unusual step of having a county physician write individual treatment recommendations for each affected resident after the second round of testing of residents was completed in September 2015.  RN Townsend was clearly unaware that in Maryland a county health officer is required to recommend appropriate treatment for latent TB infection.  CMS Ex. 38 at 19 (Md. Code Regs. 10.06.01.21(b)(2)).  However, RN Townsend testified that the recommendations were only in written form and after they were sent to Petitioner by facsimile, they could not be located.  CMS Ex. 44, Tr. 493-504, 510-12, 530-31.  I find RN Townsend's testimony regarding preparation and transmission of treatment recommendations credible.  Her testimony is consistent with an October 26, 2015 email she sent that indicates recommendations were sent to Petitioner's medical director.  CMS Ex. 48 at 38-40.  However, RN Townsend did not testify in her declaration when the recommendations were sent or to any knowledge that the individual recommendations were actually received by Petitioner's medical director or Petitioner's staff.  RN Townsend did not testify that there was any attempt to verify Petitioner's receipt of the treatment recommendations.  There is also no evidence that RN Townsend, RN Fontana, or the county health officer explained that Maryland specifies either isoniazid (INH) or rifampin is used for treatment of latent TB infection for six to nine months depending on the treatment regime.  CMS Ex. 39 at 20-21, 28-30, 59.  Advising Petitioner's staff of the Maryland policy on treatment for latent TB infection may not have satisfied the Maryland regulatory requirement that the health officer provide treatment recommendations for latent TB infection.  However, it is surprising that county health department staff did not advise Petitioner's staff that there were only two choices of treatment under Maryland guidelines, either isoniazid (INH) or rifampin, with a preference under CDC guidelines for isoniazid (INH), and that information should be shared with primary care physicians so that treatment could be ordered.  RN Townsend testified that Petitioner's staff advised the county that they intended to start treatment for latent TB infection after a second round of testing of residents was finished in September 2015, but no treatment was started and Petitioner's staff advised that they were waiting due to a change in Petitioner's administrator.  Tr. 497-503.  RN Townsend testified the Maryland regulations make a facility responsible for the care and treatment of facility residents.  CMS Ex. 44 at 2.

RN Townsend testified that she learned from RN Fontana in November 2015, that treatment for latent TB infection had not been started, but she was not concerned because Petitioner's staff had done a good job with the contact investigation and she believed treatment would begin when Petitioner's new medical director was in place.  She agreed on my examination that she did no follow-up with Petitioner's staff about whether

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treatment was initiated after November 2015, but she thought RN Fontana had continuing communication with ADON Hayden.  Tr. 508-09, 512-15.  RN Townsend testified that she was not aware that treatment for latent TB infection had not been started until Resident 1 was diagnosed with active TB.  Tr. 531-32.

RN Itala Fontana was called by CMS and testified.  RN Fontana is a community health nurse with the county health department.  In her position, she serves as case manager for cases of active TB.  Tr. 557-60.  She became aware of the cases of Petitioner's two employees who had active TB in 2015 and of the resident who previously died due to TB.  She was assigned to do the contact study related to those cases by her supervisor, RN Townsend.  She participated in the May 15, 2015 meeting with Petitioner's staff and medical director, and RN Townsend.  Tr. 562-68.  She testified it is rare for the county health department to make treatment recommendations for treatment of latent TB infection.  RN Fontana was clearly unaware of the requirement of the Maryland regulation that the county health officer recommend appropriate treatment for latent TB infection.  CMS Ex. 38 at 19 (Md. Code Regs. 10.06.01.21(b)(2)).  She testified that in her opinion the medical director for the facility or the primary care physician should know that their resident is infected and order treatment.  She testified that the standard of care is to administer isoniazid (INH) and vitamin B6 for nine months.  Tr. 580-81.  She testified that during a conference call with her, RN Townsend, and Petitioner's medical director, the medical director expressed that he understood the treatment protocol.  Tr. 583-84.  She testified that the county physician did send treatment recommendations about the third of fourth week of October 2015.  Tr. 584-85, 588-90.  She testified that Petitioner did not need to receive treatment recommendations from the county physician as treatment recommendations are in the CDC guidelines.  She did not mention that Maryland guidelines also specify treatment protocols for latent TB infection.  CMS Ex. 39 at 20-21, 28-30, 59.  She testified that normally the facility medical director or physician for the resident would be notified that the resident had latent TB infection and he or she would determine what medication to use, subject to refusal by the resident or family.  If treatment was refused, then the facility would have to monitor the resident with latent TB infection monthly for at least a year for symptoms of active TB.  Tr. 590-92.  She testified that she sent treatment recommendations to Petitioner by facsimile.  She did not testify, however, that she knew that the recommendations were received by Petitioner.  She did not testify that she attempted to verify receipt of the recommendations in any way.  She testified that ADON Hayden did not tell her that she did not receive the recommendations, but clearly she did not ask.  She testified that the recommendations and the facsimile sheet were lost when the county health department moved.  Tr. 597-98.  While I accept as true her testimony that she sent the treatment recommendations to Petitioner by facsimile, her testimony does not establish that the recommendations were actually received.  She testified that she learned on November 5, 2015, that Petitioner had not started treatment for any resident with latent TB.  She was aware that one resident had treatment in conjunction with preparing for a kidney transplant, but it is not clear when she learned that.  On January 26, 2016, she again

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communicated with ADON Hayden and was aware that treatment for residents with latent TB infection had not begun.  Tr. 607-16.  In August 2016, she learned that Resident 1 was showing symptoms of active TB.  She testified that had ADON Hayden informed her of Resident 1's symptoms in June 2016, she would have told her to have the resident evaluated for TB.  Tr. 620-22.  On cross-examination, she agreed that not all residents had received required blood tests by November 2015 or January 2016.  She also agreed that in November 2015, she agreed with ADON Hayden to setting a meeting with Petitioner's new medical director, but she did not follow-up with that.  Tr. 634-38.

Bret Stine testified that he was Petitioner's administrator from approximately March to July 2015.  Tr. 776-77.  He testified based on his 35 years as a nursing home administrator in Maryland with frequent interactions with Maryland county health departments, that he understood the nursing home is responsible to report to the county health department and the health department provides guidance and takes the lead directing action by the nursing home.  He testified that Petitioner's policy (P. Ex. 6 at 1) is that in the case of TB, the county health department was to be notified and its recommendations for investigation and follow-up were to be followed.  Tr. 780-84, 801.  He testified he attended the May 15, 2015 meeting.  County representatives told Petitioner's staff in attendance that the county would guide staff through the process including staff education, which occurred during a later meeting.  His understanding was that the health department would collaborate with conducting the contact investigation and throughout the entire process.  He testified that Petitioner's medical director, Dr. Passi, also attended the May 15, 2015 meeting.  He recalled that Dr. Passi indicated he would be following the health department direction.  Tr. 789-93.  He testified that no treatment recommendations were received from the county prior to his departure from Petitioner in July 2015.  Tr. 793.  He agreed in response to my questing that he would expect that a positive test for TB exposure would be documented in a resident's clinical record.  Tr. 797.

Eduardo Salazar testified that he became Petitioner's administrator when Mr. Stine departed in July 2015 and he continued in that role until the end of 2016.  Tr. 809-12.  He was briefed on the situation with TB when he took over.  Tr. 813.  He testified that Dr. Passi was medical director until about November 2015, and was followed by Dr. Ajani in that role.  Tr. 814-15.  He testified that Dr. Passi and later Dr. Ajani attended monthly quality assurance committee meetings he also attended at which the TB outbreak was discussed.  Tr. 815, 822.  Mr. Salazar testified that ADON Hayden was the infection control nurse throughout the entire period of the TB outbreak.  He testified he was aware of no written or oral direction from the county health department for treatment of residents.  He recalled that it was explained to him when he took over that they were following the direction and guidance of the county health department for handling the TB outbreak and they were waiting for further guidance.  He testified that they continued to wait until August 2016, when the second contact investigation started, which was triggered by Resident 1 developing active TB.  Tr. 816-18.  In response to my question he

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stated he was not certain that a TB test result would be recorded in a resident's clinical record.  Tr. 818-21.

John Loome, MD, testified.  He is the senior vice-president of medical affairs for Genesis Healthcare, East Division, which is the manager and operator of Petitioner.  Tr. 845-49.  He provides oversight and guidance to medical directors of approximately 125 facilities operated by Genesis.  Tr. 849-50.  He testified that TB is insidiously contagious so that everyone in Petitioner's facility was at risk when employees had active TB in the spring of 2015, and there was also risk for the community.  Therefore, the county health department had to be involved.  He agreed that there is a legal requirement to notify the county health department and it is standard of practice to do so.  Tr. 854-57.  He opined that if one has latent TB infection or active TB, it is the responsibility of the county health department to ensure that an investigation is done and treatment provided.  Tr. 864.  He opined that it is the county health officer's responsibility to recommend a course of treatment for latent TB infection.  Tr. 868-76; CMS Ex. 38 at 19.  He testified that Genesis policy is that facility staff must contact the county health department and follow their lead and direction.  Tr. 877.  He testified that he attended the May 15, 2015 meeting with Dr. Passi, Petitioner's medical director, some of Petitioner's staff, and representatives of the county health department.  He discussed the meeting with Dr. Passi thereafter, and they both believed that the county health department would give recommendations and direction for residents with latent TB infection.  Tr. 878-86; CMS Ex. 38.  On cross-examination, he testified that he did not recall Dr. Passi or other staff stating that they had trouble contacting or obtaining information from the county health department during the period May 2015 to August 2016.  He stated that his only involvement during the period May 2015 to August 2016, was attending the meeting on May 15, 2015.  Tr. 894-96.  He testified that he first learned in October 2016, that the health department had not provided information requested by Petitioner's staff when he spoke with Dr. Passi who he agreed was not Petitioner's medical director at the time.  Tr. 906-08.  Dr. Loome testified on cross-examination that he participated in selecting Dr. Ajani to succeed Dr. Passi as Petitioner's medical director in October 2015.  He testified that Dr. Ajani was aware of the TB outbreak at Petitioner when he took the position.  Tr. 923-24.

DON Odunubi was called to testify by Petitioner.  Tr. 940.  She testified that her understanding from meetings with county health department staff at Petitioner on May 15, 2015 and June 11, 2015, was that the county staff would instruct them on the plan of care for residents and staff at Petitioner.  Her understanding of Petitioner's infection control policy was that they were to notify the county health department and to follow the county recommendations for investigation and follow-up.  She testified that no written guidance or recommendations for treatment of latent TB infection were received from the county between May and November 2015.  She testified that RN Fontana never told her that recommendations for treatment of latent TB infection had been faxed.  Tr. 946-49, 951.  She testified on cross-examination that she recalled no communication between her

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and the county health department other than the meetings in May and June 2015.  Tr. 954.  DON Odunubi testified that it was not Petitioner's practice to update a care plan in the case of a positive TB test with a negative chest x-ray, unless treatment is initiated.  She testified that Resident 4's care plan was updated when she began treatment and so were the care plans of residents for whom treatment was initiated in the fall of 2016.  Tr. 1075-77.  She testified that it was not the practice of physicians at Petitioner's facility to enter a diagnosis of latent TB in a resident's clinical record.  According to DON Odunubi, 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.16  Tr. 1086-88.  DON Odunubi did not explain how staff was to know to monitor for signs and symptoms of active TB if there was no care plan or even a diagnosis listed in the resident's clinical records.  DON Odunubi's suggestion that only monitoring of a resident with latent TB infection is all that is required is clearly at odds with CDC guidelines (CMS Ex. 53 at 60; P. Ex. 4 at 7), Maryland guidelines (CMS Ex. 39 at 12-14, 19), and Petitioner's TB management policy (P. Ex. 6).  On cross-examination, DON Odunubi agreed that patients with a positive TB test and negative chest x-ray should be treated.  Tr. 1094.

ADON Hayden was called to testify by Petitioner.  Tr. 970-71.  She testified that in her capacity as infection control nurse she was responsible for monitoring both staff and residents for TB.  Tr. 971-72.  She testified that as an RN she had no authority to order testing or treatment.  Tr. 976.  She testified that she recalled that during the May 15, 2015 meeting with the county health department representatives there was a question about whether the county health department would be providing medications and the answer

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was that Petitioner would provide the medications.  Tr. 996.  She testified that she understood based on comments from RN Townsend that the county would take the lead and guide Petitioner throughout the process, including providing specific directions, helping with testing, and recommending medications for treatment of latent TB infection.  Tr. 998.  She testified that the county was requested to make recommendations for the type of medication and duration of treatment for latent TB infection.  Tr. 1000.  ADON Hayden testified that in order for chest x-rays to be performed for residents with a positive skin test for TB exposure, it was necessary to obtain a physician's order.  When the chest x-rays were done, the results were sent to the physician to give any additional orders.  All the chest x-rays performed for residents were negative.  Employees identified by a positive skin test for TB were handled by the county health department.  Tr. 1009-13.  She clarified that skin testing was ordered by Petitioner's medical director and chest x-rays were ordered by individual physicians.  I accept her testimony as true.  However, ADON Hayden did not explain why individual physicians were not asked to order treatment for latent TB infection when they were provided the chest x-rays that they ordered because their patients had a positive skin or blood test for TB.  The medical director was not the treating physician for all the residents and there were three other attending physicians at the time.  The medical director also issued orders for blood testing requested by the county health department.  Tr. 1020-22.  She testified that before he departed as medical director, Dr. Passi asked whether she had received treatment recommendations for the county health department.  ADON Hayden testified she received no treatment recommendations from RN Fontana by facsimile in 2015.  Tr. 1022-24.

ADON Hayden testified regarding Resident 1, and some of the resident's clinical records from June 4, 2016 to August 2016, are in evidence as P. Ex. 10.  ADON Hayden testified that Resident 1 had a positive skin test for TB followed by a negative chest x-ray during the first round of testing in May 2015, but that is not reflected by the few documents from the resident's clinical record in evidence.  She testified that Resident 1 had no signs or symptoms of active TB in May or June of 2015.  The resident did have a history of emphysema and chronic obstructive pulmonary disease and other diagnoses before May 2015.  ADON Hayden testified that Resident 1 had a change of condition on June 4, 2016.  Tr. 1024-31, 1055.  In response to my questions, she agreed that when Resident 1 had a positive TB skin test and a negative chest x-ray, the resident had latent TB infection.  She was not aware whether Resident 1 was considered to have a change in condition in 2015 when testing showed she had latent TB infection.  She agreed that nursing notes from June 2016 (P. Ex. 10 at 1-4) do not indicate that the resident had latent TB infection.  She testified that staff may not have focused on the resident immunization status where the positive skin test would have been documented.  She did not believe that latent TB had been added to the resident's "face sheet," a document which follows a resident when transferred to a hospital.  She testified that she did not believe latent TB infection was entered on the face sheet of any resident.  She also testified that she did not believe that the interdisciplinary team for any resident updated a

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resident care plan based on the fact that testing showed a resident had latent TB, and she agreed she would have been involved in care planning related to infection control.  She testified that updating resident face sheets and care plans would involve no direction or guidance from the county health department.  Tr. 1032-39.  ADON Hayden testified that a determination that a resident had latent TB infection would trigger a care plan update for symptom surveillance.  She testified that symptom surveillance was done, but she was not aware of any care plans being updated for any residents in 2015.  Tr. 1039-40, 1045.  She did not explain how staff was to know to do symptom surveillance without a diagnosis in the resident's clinical record or a care plan.  She testified that ordinarily a nurse would not question a physician's diagnosis or treatment order, unless there was an obvious issue.  Tr. 1049.

ADON Hayden testified regarding Resident 4.  Resident 4 required treatment for latent TB infection before undergoing a kidney transplant.  On November 5, 2015, ADON Hayden reported to RN Fontana at the county health department that Resident 4 had treatment for latent TB infection ordered by a physician at the institution where the transplant was to be done (P. Ex. 20).  She testified the treatment was administered by Petitioner's staff.  Tr. 1059-61.

ADON Hayden testified that she told RN Townsend that she wanted to put off any treatment for residents with latent TB infection until the second round of testing of residents was complete.  She testified that RN Townsend agreed.  She testified that she did not have the discussion with RN Fontana, contrary to RN Fontana's testimony.  Tr. 1065.  She testified that when RN Fontana asked on November 5, 2015, whether treatment of residents with latent TB infection had begun, the second round of testing was complete except for the four residents who required blood draws that were difficult draws.  She testified that she did not have further discussion regarding the question.  Tr. 1066-67.  She testified that she expected RN Fontana to get in touch with her because she knew that the county health department was making a move and latent TB is not contagious.  She testified that Petitioner just continued to do symptom surveillance.  Tr. 1067-68.  After Resident 1 was diagnosed with active TB in August 2016, resident testing and chest x-rays were done again.  Thereafter the county nurse practitioner and county physician issued orders for the treatment of latent TB infection with INH and vitamin B6 with liver function tests.  Tr. 1069-71.

Expert Testimony and Opinions

Commander (CDR) Sapna Bamrah Morris, MD

The parties agreed to take the deposition of the CMS expert witness CDR Morris with the Public Health Service, in advance of hearing due to her unavailability during the scheduled hearing.  Her deposition was admitted without objection as CMS Ex. 49 and her declarations as CMS Exs. 42 and 46.  CMS offered CDR Morris as an expert in the

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management of public health TB prevention and control programs.  CMS Ex. 49 at 4-5.  Based on consideration of CMS Ex. 42 pages 1, 2, and 16 through 30, I conclude CDR Morris is an expert in the area of disease prevention and control, specifically TB, and well-qualified to render expert opinions in that area (Tr. 1109).  See Fed. R. Evid. 702-704.

CDR Morris opined based on the evidence that she reviewed from this case, that TB had been transmitted to identified residents.  However, Petitioner failed to document whether those residents were eligible for treatment of latent TB infection.  CMS Ex. 42 at 11-12.  Her opinion is credible and weighty as Petitioner has conceded that, while the resident's records reflect positive TB tests and chest x-ray results, they contain no diagnosis of latent TB infection or determination by anyone qualified as to whether treatment was appropriate or contraindicated.  Tr. 142-45; 295-96.  CDR Morris opined that because residents with tests indicating latent TB infection were not treated, they were at risk to progress or convert to active TB, which is what happened to Resident 1.  She opined that Resident 1 was not properly isolated or evaluated for active TB when symptoms appeared, placing staff and residents at risk.  CMS Ex. 42 at 12.  CDR Morris opined that in April and May 2015, after learning about two staff with active TB, Petitioner acted appropriately by contacting the county health department and doing a contact investigation as directed, and identifying staff and residents who had contact with the two infected employees.  Appropriate TB tests were administered followed by chest x-rays.  CDR Morris opined that the residents should have been diagnosed as having latent TB infections not later than September 2015.  She opined that all residents assessed as having latent TB infection should have been offered and treated for latent TB infection absent a contraindication that should have been documented in their clinical record.  CMS Ex. 42 at 12-15, 119.  CDR Morris opined that in lieu of treatment for latent TB infection, a strict monitoring protocol should have been initiated, but there is no documentation in the files of Residents 1, 5, 6, or 7 that there was active surveillance of the type she describes with periodic symptom screening, physical examination, and chest x-rays.  CMS Ex. 42 at 13.  The parties provided me with only limited records for the four residents, so it is not possible for me to assess the weight to be assigned to CDR Morris' opinion that there is no documentation in the resident files of active surveillance.

CDR Morris opined that Resident 1 had symptoms consistent with active TB in May and June 2016, but was not diagnosed until August 2016.  Between June and August 2016, Resident 1 posed a risk for TB infection to other staff and residents.  CMS Ex. 42 at 14.

On cross-examination, CDR Morris clarified that her opinion that the documentation of follow-up of residents who tested positive for latent TB infection was inadequate, was based on the standard of care applicable to management of TB and she had no idea how that related to the applicable standard of care in the long-term care facilities.  CMS Ex. 49 at 14-15.  She testified on cross-examination that practitioners from county health departments do not generally write orders in healthcare settings.  Health department

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physicians or their extenders would only write orders for those they see in their own clinic.  CMS Ex. 49 at 37.  CDR Morris testified that the testing procedure followed by Petitioner in May through August 2015, was acceptable.  The two active staff cases were identified.  Resident contacts with the two active cases were tested.  Those residents who tested positive were given a chest x-ray to rule out active TB and then were ready for treatment for latent TB infection.  Residents who tested negative were given a second test eight to 10 weeks later in August 2015.  Those who tested positive had active TB ruled out by a chest x-ray and they were then ready for treatment for latent TB infection.  Residents who had a second negative test did not have latent TB infection.  She testified it was acceptable to delay treating the group identified in May 2015 as requiring treatment until the August 2015 group was identified so that all were treated as a cohort.  CMS Ex. 49 at 53-54.  CDR Morris testified that the infection control nurse and physician should know when treatment for latent TB infection is appropriate based on the CDC guidance.  She agreed that a physician or practitioner needed to issue the order for treatment and that there may be contraindications for treatment.  CMS Ex. 49 at 56.  CDR Morris testified that an order for treatment would not be issued by a county health department but by the treating physician because a county health department would not have access to a resident's entire medical history.  The only exception she noted is if the resident went to a county health department and was evaluated.  CMS Ex. 49 at 57-60, 67.  She clarified that the health department medical director would know about the source case of TB and could advise Petitioner whether standard prophylaxis medications could be used and which residents should be considered for treatment.  However, Petitioner could have proceeded absent advice from the county medical director as was often done.  CMS Ex. 49 at 85-86.  She testified that the facility should have known the correct procedures for residents based on the CDC guidelines, educational materials that discuss the standard of practice, Maryland state regulations, and the TB infection control plan.  CMS Ex. 49 at 67.  CDR Morris further clarified that latent TB infection is not a condition that is reportable to the public health authority which has no authority over latent TB infection, even if there is a high risk for infection.  CMS Ex. 49 at 77, 130-31.  CDR Morris was apparently unfamiliar with the Maryland regulation that requires a health officer to recommend appropriate treatment for latent TB infection.  CMS Ex. 38 at 19 (Md. Code Regs. 10.06.01.21(b)(2)).

CDR Morris testified on cross-examination regarding Resident 1, that she had a positive TB test in May 2015 and a negative chest x-ray indicating that she had latent TB infection and not active TB.  The resident's baseline testing on admission to Petitioner showed she had a negative TB test, which is evidence that her exposure to active TB was recent and likely Petitioner's employee was the index that was infectious.  CDR Morris could find no information in the evidence she was given showing that Resident 1 was informed, educated, and offered treatment for latent TB infection, or whether she accepted or refused treatment.  She found no evidence of treatment after the resident tested positive for latent TB infection in 2015, and it is known she did not receive treatment at that time.  CDR Morris opined Resident 1 was at high risk in the first two

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years after exposure and she should have received treatment for the latent TB infection or have been monitored closely for symptoms consistent with active TB.  In June 2016, Resident 1 developed a cough and complained of chest pain, and a chest x-ray was done showing classic signs of active TB, which should have caused a medical evaluation to rule out TB.  The resident's physician diagnosed bronchitis which was inconsistent with the x-ray findings.  She further opined that Petitioner's infection control nurse should have recognized the symptoms of possible active TB if she was monitoring the resident.  She opined that Petitioner's staff should have alerted Resident 1's physician of her risk for developing active TB.  CMS Ex. 49 at 91-102, 105-11.

CDR Morris testified that it is standard of care to provide treatment for latent TB infection.  CMS Ex. 49 at 131.  It is also necessary for a resident's caregiver to be informed of the latent TB infection.  CMS Ex. 49 at 134-36.  CDR Morris testified that there is no requirement for a healthcare facility such as Petitioner to wait for direction from the county health department on how to proceed to treat latent TB infection.  CMS Ex. 49 at 163-66.  She testified that those living in a congregate setting with latent TB infection should be treated unless there is a contraindication or they refuse treatment in which case they should be monitored for two years if there was a recent exposure.  She opined that the fact Resident 1 had an exposure and within two years developed symptoms of active TB that were not identified by Petitioner's staff, indicates that monitoring was not being done.  When on or about June 4, 2016, Resident 1 showed signs and symptoms consistent with possible active TB, she should have been isolated under both CDC and state guidelines.  CMS Ex. 49 at 166-70.  She opined that Resident 1 was at risk for possible death because of the delay in diagnosis of active TB.  Other residents were also at risk for progression to active TB which can be life-threatening.  CMS Ex. 49 at 188.

Richard A. Hodder, MD

Richard A. Hodder, MD provided a declaration admitted as P. Ex. 31 and testified at hearing.  Tr. 653.  Based on Dr. Hodder's testimony (Tr. 663-71; P. Ex. 31), and his curriculum vitae (P. Ex. 30), I accept Dr. Hodder as well-qualified to render opinions related to long-term care and infectious disease medicine, including active TB and latent TB infection (Tr. 1107).  See Fed. R. Evid. 702-704.  A letter from Dr. Hodder to counsel for Petitioner was also admitted as evidence without objection as P. Ex. 29.  He opined that the 2005 CDC guidelines and the Maryland guidelines from 2007, place the primary responsibility for ensuring the quality and completeness of TB services, including planning for the treatment and follow-up with contacts to someone with active TB, upon the county health department.  P. Ex. 31 at 7.  He testified that Petitioner's policies and procedures (P. Ex. 6) stress the role of the county health department and impose no requirement for either Petitioner's medical director or a resident's physician to take the lead to initiate investigation of contacts or order treatment of a resident with latent TB infection.  He testified:  "I know that when I was a long term Medical Director, I would

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not issue blanket TB prophylaxis orders without specific direction from the local public health authority."  P. Ex. 31 at 8.  This testimony is credible and significant because it shows that as a medical director, Dr. Hodder knew it was his responsibility to order treatment for latent TB infection, however, he only did so with specific direction from the local public health authority.

Dr. Hodder opined that the county health department seriously departed from CDC and Maryland guidelines in March and April 2015, by not taking immediate action to declare a significant public health emergency and to dispatch a professional team to Petitioner to provide on-site direction and follow-up every day.  P. Ex. 31 at 9-10, 12.  While I accept Dr. Hodder's opinion, the Montgomery County, Maryland health department is not subject to my jurisdiction and the conduct of the department is not on trial before me.

Dr. Hodder opined that someone from the county health department should have assessed the residents for treatment for latent TB infection, determined which residents should have started treatment, and either recommended or given orders for treatment.  P. Ex. 31 at 13-15.  Dr. Hodder does not reveal the basis for his opinion, which I read to be that the county health department should assume the responsibility to diagnose and treat residents.  I have received no evidence that it is standard of care for a county health department to assume responsibility for the treatment of long-term care facility residents.  He opined it is improbable that any recommendations for treatment were sent by the county health department to Petitioner.  P. Ex. 31 at 15.  This is not an opinion within Dr. Hodder's scope, rather it is a judgment I must make by weighing the evidence.  I accept as fact that Dr. Hodder found or was given no recommendations for treatment from the county health department, which is consistent with the fact that ADON Hayden denies receipt of recommendations and the county health department concedes it cannot find the recommendations sent to Petitioner by facsimile.  I do not find that no recommendations were made, simply that no recommendations were actually received by Petitioner's staff.

Dr. Hodder expresses the expectation that the county health department would have provided close supervision and follow-up for treatment ordered for residents for latent TB infection.  He found no evidence of follow-up by the county health department.  P. Ex. 31 at 15.  His opinion assumes that the county health department prescribed treatment, but there is no evidence to support that assumption.  Rather, the evidence shows that the county health department sent treatment recommendations, not received by Petitioner, not that the county health department ordered a specific course of treatment and undertook to care for residents with latent TB infection, at least not until September 2016 (P. Exs. 26-27).  Dr. Hodder points out that in September 2015, a county health department representative drew blood from staff members and eight residents.  However, because the blood draw was unsuccessful for four residents, the county was to send a phlebotomist to attempt another blood draw.  He states he understood the county did not complete the blood draw for the four residents who required a phlebotomist.  P. Ex. 31 at 16.  While it may be true that the county failed to draw blood for the four residents, the county health

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department is not subject to my jurisdiction.  Furthermore, the fact that blood was not drawn for TB testing from four residents, does not address the other residents who were known to have latent TB infection and were not treated.  He notes that quality assurance committee minutes from January 2016, show that Petitioner continued to wait for direction from the county health department.  P. Ex. 31 at 16.  He acknowledges that on November 5, 2015, the county health department asked whether Petitioner's medical director had started treatment for the residents with latent TB infection.  ADON Hayden responded that no treatment had begun because the prior medical director had departed, and she asked for a meeting with the county health department representative, RN Fontana.  P. Ex. 31 at 17; P. Ex. 18 at 4-6.  He opines it is astonishing that ADON Hayden's response did not trigger an immediate response from the county health department.  P. Ex. 31 at 17.  Dr. Hodder overlooks the fact that ADON Hayden's response was not that treatment was not started because Petitioner was awaiting recommendations or orders from the county health department.  The fact that the county health department did not immediately respond is questionable, but that department's failures are not subject to my review.  The question from the county health department also did not provoke an immediate reaction by ADON Hayden or Petitioner's staff.  Clearly the question of whether treatment had begun shows that the county health department had some expectation that treatment should have begun.  Dr. Hodder observes that ADON Hayden advised RN Fontana that Petitioner had a new medical director and a meeting needed to be set to figure out a plan, but there was no response from the county.  Dr. Hodder states he is unsure what further action ADON Hayden could have undertaken.  P. Ex. 31 at 18.  I note that there is also no evidence that ADON Hayden advised the new medical director of the county health department inquiry.  I find no evidence that the new medical director attempted any follow-up with the county health department.  Dr. Hodder stresses that Petitioner had a TB outbreak and that the county health department was astonishingly derelict in its failure to follow-up.  P. Ex. 31 at 17.  He does not comment upon the new medical director's failure to address the TB outbreak at Petitioner or suggest that the new medical director had a responsibility to take action to clarify the situation with the county health department so that treatment could be initiated expeditiously.

Dr. Hodder opines that Resident 1's symptoms, which manifested on June 4, 2016, could have been evidence of active TB, but the radiologist did not report a suspicion of active TB or any disease to the resident's physician.  Resident 1's physician diagnosed acute bronchitis and ordered an antibiotic with improvement.  Dr. Hodder points to no evidence that the resident's physician or the radiologist were informed that Resident 1 previously tested positive for latent TB infection.  However, he opines that there was no reason why Petitioner's nurses, who were supposed to be monitoring Resident 1 for signs and symptoms of active TB, would question the treating physician's diagnoses.  Dr. Hodder expressed no opinion regarding whether Petitioner's medical director had a duty to alert Resident 1's treating physician that she had a prior positive testing for latent TB infection and was at high risk to convert to active TB.  P. Ex. 31 at 18-20.  In August 2016, two

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months later, Resident 1 was diagnosed with active TB at which time the county health department again took action.  All of Petitioner's residents and employees were again tested.  Dr. Hodder states that the county health department then provided written orders for treatment of residents with latent TB infection.  P. Ex. 31 at 20-21.

Dr. Hodder opined that the county health department failed in its mission by not notifying Petitioner immediately in March and April 2015, that two of its employees had active TB and by failing to provide on-site supervision at Petitioner's facility as long as necessary to ensure the TB outbreak did not spread and all responses were implemented.  He notes he found no evidence that at any time in 2015, the county health department recommended or directed treatment of residents identified as having latent TB infection or conducted on-site confirmation of treatment with ongoing surveillance to ensure no residents presented with signs of active TB.  P. Ex. 31 at 21-22.  He opines that there was nothing more Petitioner's staff could have done, and ADON Hayden implemented Petitioner's infection control policy as well as she could absent direction and communication by the county department.  P. Ex. 31 at 22.  As already noted, I have no authority to review the county health department's performance of its duties.

On cross-examination, Dr. Hodder agreed that even if Petitioner did not receive treatment recommendations from the county health department for residents with latent TB infection, Petitioner was responsible to ensure that residents received treatment.  Tr. 713-14.  Dr. Hodder did not opine that treatment for latent TB infection was not required when not contraindicated.

iii.  More Than Minimal Harm

According to the CDC guidelines, the best scientific evidence presented to me and unrebutted, five percent of people with newly acquired latent TB infection progress to active TB within two years of exposure if there is no treatment.  CMS Ex. 53 at 36.  Petitioner tested its residents for TB between May and August 2015, and identified 19 to 20 residents with a positive test for TB but a negative chest x-ray, which is latent TB infection.  PPFF ¶¶ 94, 99, 103-104, 116-20; CPFF ¶¶ 29-31, 33-35, 39; CMS Ex. 22 at 16-21; Tr. 1001-1022.  One resident, Resident 4, was successfully treated for latent TB infection, per order of her physician, in connection with her preparation for a kidney transplant.  P. Ex. 20 at 1-2; Tr. 1059-61; CMS Ex. 8 at 4, 21-22, 29, 40-45.  Therefore, of the remaining 18 or 19 residents with latent TB, it was reasonable to anticipate that at least one of the residents with latent TB infection would convert to active TB within two years.  In fact, no later than August 2016, just over one year after being identified as having latent TB infection, Resident 1 did convert to active TB.

According to CDR Morris, if not treated properly active TB can be fatal, and five percent of patients diagnosed in the United States each year with active TB are either dead when

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diagnosed or they die during treatment.  CMS Ex. 42 at 2-3, 5.  This opinion is not rebutted or challenged and is accepted as credible.

The risk for death associated with conversion to active TB is certainly a risk for more than minimal harm.  The effects of treatment for active TB might also be more than minimal harm, but CMS presented no evidence of any adverse side effects from treatment for active TB or other risks associated with such treatment.

iv.  Key Findings of Fact

In May and August 2015, Petitioner's staff and the county health department conducted two rounds of TB testing of residents who might have been exposed to an employee with active TB.  Testing showed 19 or 20 residents with TB exposure and a list was provided to the county health department.  Chest x-rays showed that none of the residents had active TB in 2015.  The second round of testing was completed in August 2015, except for blood tests for four foreign born residents.  PPFF ¶¶ 94, 99, 103-104, 116-20; CPFF ¶¶ 29-31, 33-35, 39; CMS Ex. 22 at 16-21; Tr. 1001-1022.  There is no question that Petitioner's staff did a good job conducting the contact investigation and testing of residents in 2015, as attested to by RN Fontana.  Tr. 578.

Blood tests were conducted by the county health department, and blood test results for only five residents were provided to Petitioner's staff.  Tr. 1006-07.

There is no question that a positive TB test and negative chest x-ray shows that one has latent TB infection.  CMS Exs. 30 at 10; 41 at 46; 42 at 3-4; 49 at 126-29; 53 at 4, 12.  Petitioner concedes that a resident who had a positive test for TB and a negative chest x-ray should be treated at some time.  P. Br. at 3.

Resident 4, one of the residents identified as having latent TB infection in 2015, was treated beginning about October or November 2015, pursuant to an order from a physician who evaluated her in preparation for a kidney transplant.  PPFF ¶¶ 121-123; CPFF ¶ 40; CMS Exs. 14 at 129; 28 at 2; P. Ex. 20 at 1-2.

There is no dispute that the remaining 18 to 19 residents identified as having latent TB infection in 2015, including Resident 1, received no treatment for latent TB infection until September 2016.  P. Reply at 16-17.

Petitioner's infection control policy, the part of that policy specifically applicable to TB, required that one identified with a positive TB test and a negative chest x-ray must be referred for medical evaluation for treatment.  P. Ex. 6 at 6-7.  Petitioner's policy did not say how quickly the medical evaluation needed to be requested.  However, the unrebutted evidence shows that five percent of all persons with latent TB infection will convert to active TB infection, in many cases becoming infectious, within two years of exposure to

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TB.  CMS Ex. 53 at 36.  If not treated properly, active TB can be fatal, and five percent of patients diagnosed in the United States each year with active TB are either dead when diagnosed or they die during treatment.  CMS Ex. 42 at 2-3, 5.  Active TB in the throat or lungs can be infectious while active TB in other parts of the body are generally not.  Active TB is most likely to be spread among people who spend time together every day.  CMS Ex. 42 at 3.  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.  The CDC stresses that the treatment of latent TB infection is essential to control and eliminate TB because it substantially reduces the risk that M. tuberculosis will progress to TB.  CMS Ex. 41 at 55.  Although Petitioner has suggested through its briefs that its medical directors and ADON Hayden had little or no experience handling a TB outbreak, Petitioner has never suggested that they did not know of the risk of conversion from latent TB to active TB and the risk that posed to all staff and residents for serious harm and possible death.  Based on the known risks associated with TB, I infer that Petitioner's policy, which is not alleged to be defective, requires prompt action by Petitioner's staff for all steps required for handling a TB outbreak.

Regardless of how promptly Petitioner's staff may be expected to follow Petitioner's infection control policy, in this case, the 18 or 19 residents identified as having latent TB infection in 2015, were never referred to their primary care physicians for evaluation for treatment.  Therefore, Petitioner's staff failed to follow an express requirement of Petitioner's infection control policy.  Based on that failure, I find that Petitioner did not implement or maintain its infection control policy, which is the basis for noncompliance cited in this case.

There is no dispute that a decision was made to delay prophylactic treatment of the latent TB cases until after the second round of testing of Petitioner's residents was completed.  Both the county health department and Petitioner's staff were aware of that decision.  Tr. 585-87, 633-34, 1065; PPFF ¶ 111; CPFF ¶ 32.  There is no evidence of any agreement between Petitioner's staff and the county health department or direction from the county health department as to how long treatment for latent TB infection could be delayed.  There is also no evidence that the risk posed to residents due to the delay was actually assessed by either the county health department or Petitioner.17  There is no evidence that

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any of the residents' physicians who should have been involved, Petitioner's medical directors, and the county health officer, were actually involved in decision-making regarding delayed treatment for latent TB infection.

b.  Analysis

The parties have advanced multiple theories in their briefs and their arguments at hearing.  Indeed, it is easy to lose focus in this case on the key facts and issues because the parties pursue many threads that have little or nothing to do with the actual deficiency citation.18  It is important to understand that the noncompliance alleged in the SOD and cited by CMS's initial determination defines and limits the facts and issues that require my de novo review.

The regulation Petitioner is alleged to have violated 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.

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(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.

42 C.F.R. § 483.65.  The regulation requires that Petitioner establish and maintain an infection control policy.  The Board in addressing 42 C.F.R. § 483.65 has held that the regulation requires that a facility do more than merely adopt an infection control policy, the regulation requires that the policy be implemented.  Golden Living Ctr. – Superior, DAB No. 2768 at 7 (2017); Heritage House of Marshall Health & Rehab. Ctr., DAB No. 2566 at 12 (2014); The Windsor House, DAB No. 1942 at 60 (2004); Park Manor Nursing Home, DAB No. 2005 at 60 (2005).

Surveyor Slade testified that she was the only surveyor for the complaint investigation at Petitioner on September 27, 28, and October 6, 2016.  She testified that she drafted the allegation of noncompliance under Tag 441 in the SOD based on a violation or 42 C.F.R. § 483.65.  The purpose of the survey was to investigate complaints related to a TB outbreak at Petitioner.  She declared immediate jeopardy on October 6, 2016, and immediate jeopardy was abated that day.  CMS Ex. 43 at 3-4.  Surveyor Slade testified that she concluded Petitioner violated 42 C.F.R. § 483.65 because Petitioner failed to implement proper infection control measures after residents were exposed to active TB by two infected employees; Petitioner failed to follow-up with treatment and management of multiple residents identified as at risk for exposure who had latent TB infection; Petitioner failed to ensure that a diagnosis of latent TB infection and treatment decisions were documented in clinical records, and failed to ensure treatment for latent TB infection was provided as appropriate.  CMS Ex. 43 at 4.  In the case of Resident 1, latent TB infection progressed to active TB by about June 14, 2016, but Petitioner failed to provide treatment or isolation for Resident 1 from June 14, 2016 through August 2016 when she had to be hospitalized.  CMS Ex. 43 at 4-5.  Surveyor Slade opined that the regulatory violation posed a risk for more than minimal harm and immediate jeopardy.  CMS Ex. 43 at 5.  Surveyor Slade opined that the facility was obliged to notify treating physicians of positive TB test results so that the physicians could decide whether to treat or not.  Tr. 312-13.  I do not accept Surveyor Slade's opinion that Resident 1's latent TB infection progressed to active TB on June 14, 2016.  Although Surveyor Slade is

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qualified as a surveyor, I have no evidence she is qualified to render such a diagnosis.  CDR Morris' testimony that Resident 1 had symptoms consistent with active TB in June 2014, may be viewed to bolster Surveyor Slade's opinion.  However, CDR Morris did not actually examine Resident 1 or review more than the limited records available to me in this case.  Furthermore, CDR Morris did not render a diagnosis but only opined that Resident 1's symptoms were consistent with active TB.  CMS Ex. 42 at 12, 14.

Surveyor Slade cited only four specific residents as examples under Tag F441 in the SOD – Residents 1, 5, 6, and 7.  On my examination, Surveyor Slade testified that she examined the records of only five residents who had positive tests for TB.  Resident 1 was one of the examples she examined.  She testified that Resident 1's records included two positive TB test results and a negative chest x-ray from May and September 2015.  She agreed the test results and x-ray are consistent with latent TB infection and that the interdisciplinary team should have had access to that information in Resident 1's clinical record.  She testified that she saw no diagnosis of latent TB infection entered in the resident's records, no care plan, no physician note, and nothing on the resident's face sheet.  Tr. 336-39; CMS Ex. 5.19  Petitioner conceded that while the results of TB testing were entered in resident charts, no diagnosis of latent TB infection was noted in resident clinical records because no physician from the county health department or the facility rendered such a diagnosis.  Tr. 143-44.  Petitioner agreed at hearing that there is no dispute that staff reported all positive TB test results in 2015 to the county health department, but Petitioner denies ever receiving a diagnosis or treatment orders for any resident with latent TB infection in 2015 or early 2016.  Tr. 295-96.

A precise parsing of the actual allegations in the SOD of the basis for Surveyor Slade's determination of noncompliance is required because her allegations in testimony are both more extensive and more precise than the actual findings and conclusions of the noncompliance alleged in the SOD.  Surveyor Slade alleges in the SOD that Petitioner was not in substantial compliance with the requirements of 42 C.F.R. § 483.65 for the following reasons:

Petitioner failed to ensure timely follow-up of the treatment and management of multiple residents identified as at risk for exposure to a serious infectious disease; and

Petitioner failed to record in residents' clinical records the rationale for treatment or non-treatment for the potential exposure.

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CMS Ex. 1 at 7.  More specifically the first allegation is that Petitioner identified 19 to 20 residents who were exposed to TB, evidenced by the fact they had latent TB infection, i.e., a positive test for TB followed by a negative chest x-ray, but failed to provide treatment for the latent TB infection or monitoring for those for whom treatment was contraindicated or those who refused treatment.  The second allegation is that Petitioner did not document why no treatment was provided to the residents with latent TB infection.  Documentation is important to ensure treatment decisions are based on the best and most comprehensive information and to establish that quality care was delivered.  Petitioner's infection control policies and procedures in evidence do not specifically establish or address documentation requirements, and there is no allegation that the policies and procedures were deficient for failure to establish documentation requirements.  Therefore, failure to document is not a violation of Petitioner's infection control policy or 42 C.F.R. § 483.65.  However, the absence of documentation means that there is little or no documentation that Petitioner's staff actually did what was required by Petitioner's policy and procedure, i.e., medical evaluation by primary care physicians to determine the best plan of care including treatment for latent TB infection, if not contraindicated, and monitoring.  P. Ex. 6 at 6-7.  I note that Petitioner has never actually asserted that primary care physicians conducted medical evaluations and made treatment decisions for any resident with latent TB infection other than Resident 4.  Therefore, one cannot expect to find documentation of referral for medical evaluation, medical evaluation, treatment orders, or engagement of a resident's interdisciplinary team in care planning for the treatment or monitoring of the residents with latent TB infection as required by 42 C.F.R. § 483.20(k)(2).20  I conclude that Petitioner violated 42 C.F.R. § 483.65 for the reasons alleged by the surveyor in the SOD, and alternative theories of liability mentioned by CMS at hearing and in post-hearing briefing are not discussed in detail or considered in concluding Petitioner was noncompliant.

i.  CMS's Prima Facie Case

Petitioner argues that CMS cannot make a prima facie showing in this case because CMS cannot show that the county health department sent and Petitioner received treatment recommendations for residents with latent TB infection in the fall of 2015.  P. Reply at 2.  There is credible evidence the county health department 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.  My conclusion that Petitioner violated 42 C.F.R. § 483.65, does not turn on

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whether or not Petitioner ever received treatment recommendations from the county health department anyway.21

Surveyor Slade did not allege that Petitioner did not have the required infection control policy or that the policy was defective.  CMS Ex. 1 at 6-15.  CMS also does not allege Petitioner failed to have the required policy.  Rather, it is alleged that Petitioner failed to maintain or implement its infection control program to prevent infection by treating and managing residents with latent TB infection and Petitioner failed to document a rationale for not treating residents with latent TB infection.

Pursuant to 42 C.F.R. § 483.65(a), Petitioner's infection control program must:  (1) control and prevent infections in the facility; (2) require a decision on what procedures must be applied to an individual resident, and (3) result in a record of incidents and corrective actions related to infections.  The requirements of 42 C.F.R. § 483.65(a) for Petitioner's policy to address and be implemented to control and prevent infections and require decisions related to procedures to be applied for individual residents are clearly placed in issue by the SOD in this case.  CMS Ex. 1 at 7.  The requirement of 42 C.F.R. § 483.65(a) to create a record of incidents and corrective actions, does not appear to be implicated in this case as it is not alleged that Petitioner's infection control nurse failed to create such records.  Prevention of the spread of infection is addressed by 42 C.F.R. § 483.65(b), which requires isolation of residents, prohibiting infected employees from contact with residents, and handwashing.  There is no allegation in the SOD that Petitioner failed to prohibit infected staff from contact with residents or that there was a failure to require staff handwashing.  Regarding isolation, if Resident 1 had active TB in June 2016, then clearly she should have been isolated and moved immediately under Petitioner's policy.  P. Ex. 6 at 6.  Resident 1 was not moved, however, until August 2016, when she was diagnosed as having active TB.  I do not read the SOD as clearly alleging that Petitioner violated or failed to maintain its policy because Petitioner's staff failed to isolate and move Resident 1 in June 2016.  CMS Ex. 1 at 7.  Indeed, there is no contemporaneous evidence from June 2016, which shows that Resident 1 was actually diagnosed with active TB and Petitioner's staff should have known that it needed to comply with its infection control policy related to active TB.  Accordingly, I do not

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conclude that Petitioner's failure to isolate Resident 1 in June 2016, was a failure to follow Petitioner's infection control policy.22

I conclude that CDC and Maryland guidelines and the Maryland regulations establish the standard of care for latent TB infection in long-term care facility residents.  The CDC stresses that treatment of latent TB infection is essential to control and eliminate TB.  CMS Exs. 41 at 55; 53 at 60, 70.  Nursing home residents are at higher risk for infection.  CMS Exs. 30 at 9; 41 at 7, 29; 42 at 11; 53 at 17, 60.  Residents are at highest risk for progression from latent TB infection to active TB infection during the first two years after exposure if there is no treatment.  CMS Exs. 41 at 7; 42 at 3; 53 at 12, 36.  The CDC recommends that people with latent TB infection be treated absent compelling contraindications.  CMS Exs. 42 at 4, 6; 53 at 60, 70; P. Ex. 4 at 7.  The CDC states that control of TB in nursing homes requires prompt detection and diagnosis, isolation of those who are infectious, and initiation of standard therapy.  CMS Exs. 41 at 86; 53 at 60, 70.  The CDC also states that treatment of latent TB infection can reduce the risk for death due to progression, i.e., conversion, to active TB.  CMS Exs. 32 at 5-6, 33 at 6.  The standard of care under CDC and Maryland guidelines and Maryland regulations is treatment of latent TB infection, unless contraindicated.  CMS Exs. 30 at 8; 32 at 5-6; 33 at 6; 39 at 19; 41 at 55, 86; 53 at 17, 60, 70; P. Ex. 4 at 7.  Petitioner concedes that a resident who had a positive test for TB and a negative chest x-ray should be treated at some time.  P. Br. at 3.  Preferred treatment for latent TB infection is isoniazid (INH) for six to nine months according to both the CDC and Maryland guidelines.  CMS Exs. 30 at 18; 41 at 55, 86; 39 at 20-21, 28-30, 59.  The Maryland guidelines recommend treating for latent TB infection to reduce the possibility of progression to active TB.  CMS Ex. 39 at 19.  Maryland specifies that either INH or rifampin should be used for treatment of latent TB infection.  CMS Ex. 39 at 20-21, 28-30, 59.

The Maryland regulations require that a nursing home assess all residents annually for signs and symptoms of TB.  If any signs and symptoms are detected, a physician must then evaluate for TB in communicable form, and the county health department must be notified within 24 hours if active TB is suspected.  The physician is required to coordinate the management of resident and resident's contacts with the county health

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officer.  A nursing facility is required to assess and manage a resident with possible TB in accordance with CDC guidelines.  CMS Ex. 38 at 17.

A portion of the Petitioner's infection control policy and procedures related to TB has been admitted to the record as P. Ex. 6.  Petitioner's policy requires that when TB23 is identified the health department is to be notified and the recommendations of the health department are to be followed; staff is to conduct an investigation to determine if any staff or residents have been exposed to TB; and the treatment needs of any residents exposed are to be determined.  P. Ex. 6 at 1-2.  Petitioner's TB screening procedures and post TB exposure procedures require skin testing for TB, except when blood testing is required.  If a skin test is positive, a chest x-ray is to be ordered.  If the chest x-ray is positive for TB, the resident is isolated and transferred to an appropriate facility as soon as possible.  If the chest x-ray is negative, alternative diagnoses are to be considered and the resident is to be evaluated for chemoprophylaxis, i.e., treatment of the latent TB infection.  P. Ex. 6 at 3-7.  Petitioner's policy and procedures are not inconsistent with the standard of care defined by the CDC and Maryland guidelines.

There is no dispute that between May and September 2015, 19 to 20 of Petitioner's residents were identified as having latent TB infection.  The evidence shows that Resident 4 received further medical evaluation in connection with her evaluation for a kidney transplant, and treatment for her latent TB infection was ordered by a physician related to her evaluation for the transplant with treatment administered by Petitioner's staff.  PPFF ¶¶ 121-123; CPFF ¶ 40; CMS Ex. 8 at 4, 21-22, 29, 38-45; CMS Exs. 14 at 129; 28 at 2; P. Ex. 20 at 1-2; Tr. 1059-61.  There is no dispute that the remaining 17 to 18 residents received no treatment for latent TB infection until September 2016.  Resident 1 did not receive treatment for latent TB infection but began treatment for active TB in August 2016.  P. Reply at 16-17.  There is no evidence that in 2015, Petitioner's staff informed the residents' treating physicians of the residents' positive skin tests and negative chest x-rays and requested medical evaluation of the residents by their physicians for treatment of latent TB infection, as required by Petitioner's policy and procedures.  Therefore, Petitioner's staff did not comply with Petitioner's infection control policy related to TB.  DON Odunubi testified that it was not Petitioner's practice to update care plans for residents identified with latent TB unless treatment was initiated; physicians who saw patients at Petitioner did not place a diagnosis of latent TB on residents' clinical records; and Petitioner's staff simply monitored annually for conversion from latent TB to active TB.  Tr. 1086-88.  DON Odunubi's testimony suggests that TB outbreaks were regularly dealt with at Petitioner, contrary to the representation of Petitioner throughout this case that its staff had little experience dealing

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with TB and therefore had to rely upon the county health department.  I conclude that DON Odunubi's testimony is not credible and, even if it was, her testimony does not outweigh Petitioner's policy and procedure that requires medical evaluation for a treatment for a resident identified as having latent TB infection.  There is no dispute that the residents with latent TB infection, other than Resident 4, were not evaluated for treatment by their primary care physicians in 2015 or early 2016.24

I conclude that Petitioner's infection control program, specifically the policies and procedures related to TB, was not implemented by Petitioner's staff to prevent the development and spread of active TB.  I conclude that, although Petitioner had the required policy, it was not maintained, i.e., implemented, as required by 42 C.F.R. § 483.65.  Petitioner did not implement its policy to prevent the spread of TB infection by ensuring that residents identified as having latent TB infection were treated, unless contraindicated or refused, in accord with CDC and Maryland guidelines which establish the standard of care.  Petitioner's staff failed to request the residents' primary care physicians or Petitioner's medical director evaluate the residents for appropriate treatment for latent TB infection.  More than minimal harm was posed by the regulatory violation because as demonstrated by Resident 1, there was a risk for actual harm due to the conversion to active TB.25  CMS Ex. 42 at 4-5, 13-14.  Petitioner does not dispute that

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active TB is a contagious and life threatening disease.  The potential for conversion to active TB as in the case of Resident 1, establishes that there was a risk for more than minimal harm and immediate jeopardy for all Petitioner residents, particularly those with latent TB infection.

ii.  Petitioner's argument that the county health department did not do its duty and that Petitioner was waiting on treatment recommendations from county health officials is no defense.

Petitioner urges me to find that its staff did all that was required under state and federal law for various reasons discussed hereafter and that Petitioner did not violate 42 C.F.R. § 483.65 and remained in substantial compliance.  P. Br. at 6.  Petitioner argues that CMS failed to make a prima facie showing of a violation of 42 C.F.R. § 483.65, an argument I reject based on the preceding discussion.  Petitioner also argues that it has rebutted the CMS prima facie case, an argument I address hereafter.

Surveyor Slade cited Petitioner for violating 42 C.F.R. § 483.65, not because Petitioner did not have an infection control policy but because Petitioner failed to follow, i.e., implement or maintain, its existing policy.  The surveyor alleged noncompliance because Petitioner failed to ensure timely treatment and management of multiple residents identified as having latent TB infection and because Petitioner did not document in the residents' clinical records why no treatment occurred.  CMS Ex. 1 at 7.  Therefore, this

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case turns on the facts that Petitioner had an infection control policy that required evaluation for treatment for latent TB infection (treatment could be contraindicated or refused), but no residents identified with latent TB infection during testing in 2015 were referred for treatment to their primary care physicians or received treatment prior to September 2016, except Resident 4.  Only Resident 4 received treatment administered by Petitioner's staff based on the order of an infectious disease doctor who evaluated her preparatory to kidney transplantation.  The absence of documentation of a decision to treat or not treat for latent TB infection noted by the surveyor is important as it supports an inference that there was no follow-up, no treatment, no determination that treatment was contraindicated, and no refusal of treatment by an individual resident.

The clearest statement of a theory in this case is provided by Petitioner in its post-hearing brief.  Petitioner's argument in response to the actual deficiency citation can be summarized by the following points:  all witnesses agreed that treatment for residents with latent TB was necessary; the county health department agreed to provide recommendations for treatment for individual residents; there was an agreement to wait until after the second round of testing was completed in the fall 2015; the county health department never finished collecting blood from four residents for testing; and Petitioner never provided any treatment to those residents with latent TB infection in 2015, except Resident 4, because Petitioner never received recommendations from the county health department.  P. Br. at 35; P. Reply at 16-17.  Petitioner argues that its infection control policy and procedures, specifically that part related to TB, require notification of the county health department and following the county's guidance, which Petitioner argues is consistent with CDC and Maryland guidance.  Petitioner argues it was waiting for county health department treatment recommendations of residents with latent TB infection identified in 2015, when in 2016 Resident 1 developed active TB.  The gist of Petitioner's argument is that 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.  Petitioner does not acknowledge, to the detriment of Petitioner's credibility, that primary care physicians for each of the 18 or 19 residents infected with latent TB infection could have promptly evaluated their patients and ordered treatment, for cases in which treatment was not contraindicated or refused, using one of the two antibiotics authorized by the Maryland regulations.  The example of Resident 4 proves that individual physicians can order treatment for latent TB infection and do so promptly after diagnosis.  The evidence shows that not later than November 2015, ADON Hayden was aware that treatment for latent TB infection had been ordered for Resident 4 by one of her physicians.

Petitioner challenges me to clearly delineate the respective responsibilities of the county health department and Petitioner related to the TB outbreak.  Petitioner argues that CMS has never correctly described a SNF's responsibilities under 42 C.F.R. § 483.65, because CMS has not "defined or described the respective legal responsibilities" of a SNF and a county health department under controlling standards.  P. Reply at 1-2 (emphasis in

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original), 8-16.  Petitioner agrees that it has some obligation with respect to TB control under 42 C.F.R. § 483.65 and clarifies that it does not suggest that the county health department can take over a SNF's infection control program or treat residents.  However, Petitioner argues that Petitioner's staff had little or no experience handling TB and for that reason Petitioner's policy directed that Petitioner's staff follow direction of the county health department.  P. Reply at 15-16.  Petitioner, however, argues the county health department did not do its job.  Petitioner argues it did seek county guidance and complied with all county health department guidance and CMS has failed to show that Petitioner had any additional obligation under 42 C.F.R. § 483.65.  P. Reply at 16.

Using Petitioner's summary of its theory of this case, it is relatively simple to illustrate the deficiency and respond to Petitioner's challenge.  Petitioner's obligations to its residents are set forth in 42 C.F.R. pt. 483.  Petitioner has the responsibility to deliver necessary care and services for its residents.  42 C.F.R. § 483.25.26  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."  TB is a disease.  The county health department has responsibility to oversee the prevention and management of TB.  The county health department has the responsibility under the Maryland guidelines to identify, promptly evaluate, and ensure an appropriate course of treatment is prescribed and completed for all people suspected of having TB.  CMS Ex. 38 at 10.  The Maryland regulations require that a health officer recommend appropriate treatment for latent TB infection.  CMS Ex. 38 at 19.  I accept based on undisputed evidence in this case that the county health department failed its duty because the county health department did not complete blood testing of four residents; failed to ensure that Petitioner received the county health department recommendations for treatment; and failed to ensure treatment was initiated in late 2015 or early 2016 for all residents identified as having latent TB infection.

However, the fact that the county health department did not promptly discharge its duties cannot be a defense for Petitioner's failure to follow its infection control policy as required by 42 C.F.R. § 483.65.  Dr. Passi, Petitioner's medical director, Dr. Ajani, the successor medical director, and ADON Hayden, Petitioner's infection control nurse, should have been thoroughly familiar with the respective responsibilities and their relationship with the county health department to ensure Petitioner's residents were protected to the maximum extent during the TB outbreak.  Clearly residents were not

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protected as reflected by the conversion of Resident 1 from latent TB infection to active TB.  Petitioner's policy requires medical evaluation and determination of treatment for TB, including latent TB infection.  P. Ex. 6 at 6-7.  Petitioner failed to follow its policy.  Contrary to Petitioner's argument, the alleged noncompliance in this case is not based on Petitioner's failure to follow specific directions from the county health department, or that Petitioner failed a duty to initiate treatment for individual residents who had latent TB infection.  P. Br. at 37.  The alleged noncompliance is that Petitioner failed to implement or maintain its infection control policy.  Petitioner's policy requires that if TB exposure occurs in Petitioner's facility, as happened in early 2015, the health department was to be notified and its recommendations for investigation and follow-up were to be followed; an investigation was to be done to identify if any residents or staff were exposed; and if a TB test was positive, a chest x-ray was to be done, and if the chest x-ray was negative, medical evaluation was to be obtained for treatment.  P. Ex. 6 at 6-7.

Petitioner argues that the county health department was not demonstrating any sense of urgency, and it was not for ADON Hayden or any member of Petitioner's staff to second guess the county health department.  P. Br. at 37.  Petitioner argues that the county health department's actions "at best were lackadaisical, if not negligent or worse."  P. Br. at 37.  Petitioner points out it took the county months to inform Petitioner that Petitioner had two infected employees; the county agreed to delaying treatment for at least six months after TB was identified; the county delayed blood tests and never finished some tests; and in January 2016, RN Fontana was still proposing a meeting to discuss how to proceed.  P. Br. at 37-38.  Petitioner asserts that no one involved in the investigation of the TB outbreak at Petitioner in 2015, expressed any urgency about beginning treatment for latent TB infection until nearly a year and a half after the outbreak was detected.  P. Reply at 35.  Petitioner asserts it is not clear how Petitioner's staff could discern from 42 C.F.R. § 483.65 or their experience that the county health department was botching the case.  P. Br. at 38.  Petitioner's assertions miss the point that it is Petitioner's compliance with its own infection control policy that is at issue.

Petitioner should have a much larger concern for the welfare of its residents than demonstrated by counsel's argument.  Even if I accept as true that the county health department was dilatory, 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 the Maryland regulations to recommend treatment for those residents with latent TB infection, 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 latent TB infection or, much worse, active TB and possible death.  Petitioner's medical directors were obviously not particularly engaged or they would have been calling the state health department demanding action and meeting with all the primary care physicians to ensure that they did the medical evaluation and initiated prophylaxis consistent with Petitioner's policy.  Nothing in the Maryland regulations or Maryland and CDC guidance suggests that the

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county health department may interfere with a primary care physician prescribing treatment for his or her patient, consistent with the two treatment modalities for latent TB infection specified in the Maryland regulation.  Furthermore, Resident 4's case should have triggered action by Petitioner's medical director and ADON Hayden, as Resident 4's case provided a clear example that a private physician ordered treatment for his or her patient.

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.  CMS Ex. 39 at 20-21, 28-30, 59.  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.  CMS Ex. 39 at 10.  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.  Dr. Passi or any of the other primary care physicians of the residents with latent TB infection could have ordered treatment for their residents within the scope of the Maryland guidelines.  The Maryland guidelines recognize that residents of SNFs and NFs are at risk for infection and the recently infected are at risk for conversion from latent TB to active TB.  The guidelines specify that a decision to test for TB is a decision to treat, including recent contacts with TB infection.  CMS Ex. 39 at 12-14.  Treatment should be targeted to high-risk groups including those recently infected and those in SNFs.  CMS Ex. 39 at 19.  The testimony of both CDR Morris and Dr. Hodder is consistent with the Maryland guidelines.

Petitioner argues that only the county health department had the resources to do the blood testing (QuantiFERON™) necessary for some staff and residents who were foreign born.  The county health department drew blood from 31 residents on about May 27, 2015, and from another four residents in August 2015, and never drew blood for testing from four residents who required special skills to accomplish the blood draw.  The county only provided Petitioner test results for five residents, three positive and two negative.  P. Reply at 19-20; Tr. 572-75, 1006-07.  If ADON Hayden or Petitioner's medical director believed that there were still residents who needed to have a blood test or that the county had not yet returned all of the test results to the facility, Petitioner's responsibility to its residents required follow-up with the county about those concerns.  Petitioner did not follow-up or advocate in the best interests of its residents.  Petitioner's attempts to shift blame to the county once again are therefore unpersuasive, particularly given that Petitioner knew it already had multiple residents with latent TB infection who required medical evaluation and orders for treatment under Petitioner's infection control policy.

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Petitioner concedes:

It seems obvious that in any TB outbreak it is necessary for someone to take the lead in what plainly is a fairly complicated process, to give direction, and to follow up to assure that all necessary interventions have been completed.

P. Reply at 35 (emphasis in original).  Petitioner argues that it is not clear at what point Petitioner's staff should have complained to the county health department or sought interventions by higher state authority.  Petitioner states that its expert, Dr. Hodder, was clear that he would have been more aggressive under the circumstances.  Petitioner asserts there is nothing in the regulations that shifts responsibility for handling a TB outbreak to Petitioner's staff or medical director.  P. Reply at 35-36.  Petitioner overlooks, however, its responsibilities under 42 C.F.R. § 483.25 to ensure its residents receive necessary care and services.  Petitioner also overlooks its own policy, which places upon Petitioner's staff the responsibility to ensure medical evaluations for treatment are accomplished for those with latent TB infection.  P. Ex. 6 at 6-7.  Petitioner asserts that it was not unreasonable for ADON Hayden to continue to wait on the county health department even after January 2016, because there was an agreement to delay treatment for latent TB infection until after the second round of testing was done.  In fact, as Petitioner represents, the county health department expressed no urgency about treatment even as of January 2016.  P. Reply at 36-37.  However, again Petitioner ignores its independent obligation to its residents to ensure they received necessary care and services as required by 42 C.F.R. § 483.25, in this case treatment for latent TB infection to prevent conversion of even one resident to active TB.  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 Petitioner to ensure that medical evaluation for treatment of latent TB infection was done, and Petitioner failed to follow that policy, which is the basis for the deficiency citation.

Regarding Resident 1, Petitioner speculates that the resident's physician may not have treated Resident 1 differently if she had known that the resident had latent TB infection.  P. Reply at 27-28.  Petitioner did not call Resident 1's physician as a witness and speculation is no substitute for evidence.  Whether or not Resident 1 had active TB as early as June 2016, is speculative and cannot be determined definitively on the present record.  Although CDR Morris testified Resident 1 had classic signs of TB in June 2016, she did not examine the resident and I do not give her testimony greater weight than the medical evidence reflecting Resident 1's diagnoses by her treating physician at the time.  However, the evidence does show that Resident 1 was identified as having latent TB infection in 2015, she was provided no treatment for latent TB infection, and as a result she developed active TB no later than August 2016.

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The testimony of DON Odunubi and ADON Hayden reflects a fundamental misunderstanding of CDC and Maryland guidance.  DON Odunubi testified that a positive skin test and negative chest x-ray did not result in a diagnosis of latent TB infection being placed on a resident's clinical records, or trigger a care plan revision unless treatment was initiated.  Tr. 1075-77.  She testified that Petitioner's staff simply monitored for signs and symptoms that a resident had active TB.  Tr. 1086-88.  However, she ultimately agreed on cross-examination that residents with latent TB infection ought to be treated.  Tr. 1094.  ADON Hayden testified that she was not concerned about waiting for the county health department to make treatment recommendations or issue orders because latent TB infection is not infectious and Petitioner continued to do symptom surveillance.  Tr. 1067-68.  ADON Hayden testified that it was regular practice for Petitioner's staff to note in a resident's clinical record, specifically nursing notes, signs and symptoms the resident may have been experiencing, including any respiratory or lung symptoms.  Tr. 1029-31.  However, she testified that a positive TB test, which is certainly a sign or symptom, would have been noted on a resident's immunization status, not on the face sheet that is sent with a resident when transferred.  She did not believe any diagnosis of latent TB infection was placed on a resident's face sheet.  Tr. 1034-35.  Both nurses, despite their years of experience in nursing, failed to recognize that there was a risk for a resident with latent TB infection, i.e., a positive TB test and negative chest x-ray, to convert to active TB and that treatment, not merely annual observation, was necessary to prevent conversion and exposure of other residents or staff to active TB.  They failed to recognize that under Petitioner's infection control policy related to TB (P. Ex. 6 at 6-7) a medical evaluation needed to be obtained to determine whether treatment was contraindicated, and if not, treatment should be initiated, absent a refusal.

Petitioner argues that the survey should be rejected because Surveyor Slade worked for the same state agency as RN Townsend and RN Fontana.  Petitioner reasons that there was a conflict of interest that raises a significant issue of the credibility of Surveyor Slade.  P. Br. at 6-7 n.6, 36; P. Reply at 4 n.1.  Even if Petitioner has identified a conflict of interest, this decision is not based on Surveyor Slade's testimony and observations in the SOD.  My review is de novo and my decision is amply supported based on the testimony of the other witnesses, the documents other than the SOD, and the undisputed facts.  Petitioner concedes that the Board has previously found that defects in the survey process are immaterial where there is an otherwise appropriate basis for finding noncompliance.  P. Reply at 4 n.1.

I conclude that Petitioner has failed to rebut the CMS prima facie case or to establish an affirmative defense.

5.  Petitioner failed to meet its burden to show that the declaration of immediate jeopardy related to the noncompliance under Tag F441 was clearly erroneous or that immediate jeopardy was abated before October 5, 2016.

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Surveyor Slade concluded that the violation of 42 C.F.R. § 483.65 posed immediate jeopardy to resident health and safety from June 14, 2016, through October 5, 2016.  Petitioner argues that there was no violation of 42 C.F.R. § 483.65 and no immediate jeopardy.  P. Reply at 38.

The CMS determination of immediate jeopardy must be upheld, unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS's determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  Yakima Valley Sch., DAB No. 2422 at 8-9 (2011); Cal Turner Extended Care Pavilion, DAB No. 2384 at 14 (2011); Brian Ctr. Health and Rehab./Goldsboro, DAB No. 2336 at 9 (2010) (citing Barbourville Nursing Home, DAB No. 1962 at 11 (2005), aff'd, Barbourville Nursing Home v. U.S. Dep't of Health & Human Srvs.,174 F. App'x 932 (6th Cir. 2006)); Maysville Nursing and Rehab. Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing & Rehab. Ctr.– Johnston, DAB No. 2031 at 18-19 (2006), aff'd, Liberty Commons Nursing & Rehab. Ctr.–Johnson v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).  "Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous."  Cal Turner, DAB No. 2384 at 14-15 (citing Liberty Commons Nursing & Rehab. Ctr.–Johnston, 241 F. App'x 76 at 3-4).

"Immediate jeopardy" under the regulations refers to 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, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility's provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(B)(ii).

Pursuant to 42 C.F.R. § 498.3(d)(10), a finding by CMS that deficiencies pose immediate jeopardy to the health or safety of a facility's residents is not an initial determination that triggers a right to request a hearing by an ALJ or that is subject to review.  Rather, a finding of noncompliance that results in the imposition of an enforcement remedy, except the remedy of monitoring by the state, does trigger a right to request a hearing and is subject to review.  42 C.F.R. §§ 488.408(g); 498.3(b)(8) and (13).  Furthermore, the level

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of noncompliance, i.e., scope and severity, is subject to review only if a successful challenge would:  (1) affect the amount of CMP that may be imposed, i.e., the higher range of CMP authorized for immediate jeopardy; or (2) affect a finding of substandard quality of care that rendered the facility ineligible to conduct a NATCEP.  42 C.F.R. § 498.3(b)(14) and (16).  Pursuant to 42 C.F.R. § 498.60(c)(2), in reviewing a CMP, the ALJ must uphold the CMS determination of the level of noncompliance (i.e., the scope and severity), unless it is clearly erroneous.  The phrase "clearly erroneous" is not defined by the Secretary.

Many appellate panels of the Board have addressed "immediate jeopardy."27  In Mississippi Care Ctr. of Greenville, DAB No. 2450 at 15 (2012), the Board commented:

CMS's determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); Woodstock Care Center.  The "clearly erroneous" standard means that CMS's immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  See, e.g., Maysville Nursing & Rehabilitation Facility, DAB No. 2317 at 11 (2010); Liberty Commons Nursing and Rehab Center — Johnston, DAB No. 2031 at 18 (2006), aff'd, Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt, 241 F. App'x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that "distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries."  59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994).  "This inherent imprecision is precisely why CMS's immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference."  Daughters of Miriam Center, DAB No. 2067, at 15 (2007).

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The Board's statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

We believe that a provider's burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility's obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.

59 Fed. Reg. at 56, 116, 56,179 (Nov. 10, 1994) (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive

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deferential consideration, by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board's decision in Mississippi Care Ctr. of Greenville; Daughters of Miriam Ctr., and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving deference or requiring that the immediate jeopardy determination be given deference in addition to applying the "clearly erroneous standard" would be contrary to the intent of the drafters of the regulation; would significantly limit the review of the determination by an ALJ and the Board; and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from Mississippi Care Ctr. of Greenville, that panel of the Board stated that the clearly erroneous standard means that "the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one."  Id. at 15.  Similar formulations have been used in other Board decisions when referring to the "clearly erroneous standard."  However, the Board's characterization of the "clearly erroneous standard" in Mississippi Care Ctr. and other cases does not define the standard.  The "clearly-erroneous standard" is described in Black's Law Dictionary as a standard of appellate review applied in judging the trial court's treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  Black's Law Dictionary 269 (8th ed. 2004).  The Supreme Court has addressed the "clearly erroneous standard" in the context of the Administrative Procedures Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact's existence.  In re Winship, 397 U.S. 358, 371-72 (1970); Concrete Pipe & Prods. of California, Inc. v. Constr. Laborers, 508 U.S. 602, 622 (1993).  The "substantial evidence" standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  Consolidated Edison, 305 U.S. 197, 229 (1938); Dickinson v. Zurko, 527 U.S. 150, 162 (1999).  Under the "clearly erroneous" standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  United States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948); Dickinson, 527 U.S. at 162; Concrete Pipe, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires

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meaningful review.28  Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23.

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  Dumas Nursing and Rehab., L.P., DAB No. 2347 at 19 (citing Life Care Ctr. of Tullahoma, DAB No. 2304 at 58 (2010), aff'd, Life Care Ctr. of Tullahoma v. Sec'y of U.S. Dep't of Health & Human Servs., 453 F. App'x 610 (6th Cir. 2011)).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define "likelihood" or establish any temporal parameters for potential harm.  Agape Rehab. of Rock Hill, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  Brian Ctr. Health and Rehab./Goldsboro, DAB No. 2336 at 7-8.  There is a difference between "likelihood" as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  Daughters of Miriam Ctr., DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences.  Woodstock Care Ctr., DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with "actual harm?"  On the first question the Board recognized in Yakima Valley Sch., DAB No. 2422 at 8, that the regulations do not define or explain the meaning of the term "serious" as used in the definition of immediate jeopardy.29  The

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Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term "serious."  Id. (citing Daughters of Miriam Ctr., DAB No. 2067 at 9).  In Daughters of Miriam Ctr., the Board discussed that the ALJ attempted to define "serious," finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ's definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut the presumption by showing that the actual or threatened harm met no reasonable definition of serious.  Daughters of Miriam Ctr., DAB No. 2067 at 9-10.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found based on the violations of 42 C.F.R. § 483.65, I have no definite and firm conviction that an error has been committed.  I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the deficiency under 42 C.F.R. § 483.65 was clearly erroneous.

I have concluded that Petitioner violated 42 C.F.R. § 483.65.  The violation posed a risk for more than minimal harm to Petitioner's residents due to the risk associated with exposure to TB.  I have also found and concluded that Resident 1 suffered actual harm because she did not receive treatment for latent TB infection and converted to active TB, which adversely affected her.  Petitioner challenges the determination that immediate jeopardy was posed for Petitioner's residents based on its violation of 42 C.F.R. § 483.65.  The gist of Petitioner's argument is there was no violation, no noncompliance, and no immediate jeopardy.  I conclude based on the evidence of record that Petitioner has not

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met its burden under 42 C.F.R. § 498.60(c)(2) and shown that the declaration of immediate jeopardy was clearly erroneous, including the alleged duration.

Petitioner knew in August and September of 2015, that it had at least 18 to 19 residents with positive TB tests and negative chest x-rays, indicating that those residents had latent TB infection.  The standard of care, according to the CDC (CMS Exs. 41 at 55; 53 at 17, 60, 70; P. Ex. 4 at 7), the State of Maryland (CMS Exs. 30 at 8; 39 at 12-14, 19, 20-21, 28-30, 59), CDR Morris (CMS Ex. 49 at 131), and Dr. Hodder (P. Ex. 31 at 13-15; Tr. 713-14), is treatment of latent TB infection to avoid conversion to active (infectious) TB, except when treatment is contraindicated or refused.  According to the CDC, approximately five percent of people with newly acquired latent TB infection progress to TB within two years of exposure if there is no intervention.  CMS Ex. 53 at 36.  Approximately 5 to 10 percent of people with latent TB infection who are not treated will develop TB during their lifetimes.  CMS Exs. 30 at 7; 41 at 6; CMS Ex. 42 at 3.  If not treated properly, active TB can be fatal, and five percent of patients diagnosed in the United States each year with active TB are either dead when diagnosed or they die during treatment.  CMS Ex. 42 at 2-3, 5.  Therefore, untreated latent TB infection poses a risk for conversion to active TB infection and death.  The conversion of even one resident to active TB, in this case Resident 1, can occur at any time.  CMS Ex. 42 at 15.  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.  Active TB is most likely to be spread among people who spend time together every day.  CMS Ex. 42 at 3.  The CDC stresses that the treatment of latent TB infection is essential to control and eliminate TB because it substantially reduces the risk that the bacterium, M. tuberculosis, will progress to TB.  CMS Ex. 41 at 55.  Based on the unrebutted scientific evidence, with 18 to 19 residents with latent TB infection known to Petitioner in August or September 2015, Petitioner should have known that without treatment at least one of those residents was a ticking TB time-bomb that could go off at any time exposing even more residents and staff to TB.  However, Petitioner did nothing to protect its residents choosing to wait on, using Petitioner's terms, the lackadaisical or neglectful county health department.  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.  The fact that there was an agreement to delay treatment for latent TB infection for the convenience of either the county health department or Petitioner's staff can be no excuse for Petitioner's failure to ensure there was prompt action to protect its residents.  CDR Morris's opinion that the delay was acceptable (CMS Ex. 49 at 53-54), is not acceptable except from the perspective of the scientist or clinician who might find it convenient to treat multiple residents as a cohort.  CDR Morris certainly did not suggest that there was a smaller probability of a conversion to active TB from latent TB infection during the first few weeks or months of exposure or provide any other basis for her opinion that waiting was acceptable other than for convenience.

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CMS determined that immediate jeopardy began June 14, 2016. 30  I conclude that immediate jeopardy existed no later than June 14, 2016.  I will not disturb CMS's exercise of discretion.  CMS concluded that immediate jeopardy ended October 5, 2016.  CMS Ex. 20 at 1-2.  Petitioner has not shown that the declaration or duration of immediate jeopardy was clearly erroneous.

6.  A $12,541 per-day CMP from June 14 through October 5, 2016, the period of immediate jeopardy, and a $303 per-day CMP from October 6 through December 11, 2016, a total CMP of $1,449,975, is a reasonable enforcement remedy.

Petitioner did not request review of the noncompliance cited as violations of 42 C.F.R. §§ 483.20(k)(3)(i) (Tag F281) (s/s D), 483.35(i) (Tag F371) (s/s E), and 483.70(h)(4) (Tag F469) (s/s E); those citations of noncompliance are administratively final; and the citations are bases for the imposition of enforcement remedies.  Petitioner also did not request review of the reasonableness of the $303 per-day CMP based on the unchallenged noncompliance citations for the period October 6 through December 11, 2016, and that remedy is administratively final and not subject to further review for reasonableness.  I have concluded that Petitioner violated 42 C.F.R. § 483.65 and that the violation posed a risk for more than minimal harm to one or more facility residents.  I have also concluded that Petitioner failed to meet its burden to show that the declaration of immediate jeopardy was clearly erroneous.  Therefore, it is necessary to assess the reasonableness of the CMP CMS proposes for the period of immediate jeopardy.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per-day CMP for the number of days that the facility is not in

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compliance or a per-instance CMP for each instance that a facility is not in substantial compliance, whether or not the deficiencies pose immediate jeopardy.  42 C.F.R. § 488.430(a).

A CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  Relevant here, the upper range of a CMP, $6,291 per day to $20,628 per day, is reserved for deficiencies that pose immediate jeopardy to a facility's residents and, in some circumstances, for repeated deficiencies.  42 C.F.R. § 488.438(a)(1)(i), (d)(2); 45 C.F.R. § 102.3 (Table).

I conclude that there is a basis for the imposition of a per-day CMP based on the noncompliance that posed immediate jeopardy in this case.  If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility's history of non-compliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility's degree of culpability, including but not limited to the facility's neglect, indifference, or disregard for resident care, comfort, and safety, and the absence of culpability is not a mitigating factor.  The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.  My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose, but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  Emerald Oaks, DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14–16 (1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997).

In this case, CMS proposes to impose a $12,541 per-day CMP, which is in the middle of the range of CMPs that may be imposed for immediate jeopardy.  I find the penalty amount more than justified based on the facts in this case.  Petitioner knew it had 18 to 19 residents who required treatment for latent TB infection, but failed to comply with its

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own infection control policy that required those residents be evaluated and treated for latent TB infection.  Petitioner's failure resulted in one resident converting to active TB, exposing more residents to the risk of infection with TB and serious harm or death.  Petitioner was culpable as staff knew the situation but chose to wait for action by the county health department rather than aggressively pursue evaluation and treatment for the residents.  Petitioner failed to deliver necessary care and services and neglected the needs of its residents.31  Resident 1 suffered actual harm due to her conversion from latent TB infection to active TB.  CMS Ex. 5 at 6.  Because 18 to 19 residents were involved and there were two TB outbreaks, there was a pattern of noncompliance.  Petitioner has not alleged that its financial condition is grounds for a reduction of the CMP amount.  The evidence shows that Petitioner has a history of noncompliance as it was cited with immediate jeopardy in 2014 for a violation of the requirement to deliver necessary care and services.  CMS Ex. 21 at 2.

I conclude that a $12,541 per-day CMP from June 14 through October 5, 2016 is reasonable.  I further conclude that the total CMP of $1,449,975, is reasonable.

III.  Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with program participation requirements from June 14 through December 11, 2016.  There is a basis for the imposition of the following enforcement remedies, which are also reasonable:  a $12,541 per-day CMP effective June 14, 2016, through October 5, 2016; and a $303 per-day CMP effective October 6, 2016, through December 11, 2016.

• 1. Citations are to the October 1, 2016 revision of the Code of Federal Regulations (C.F.R.), which were in effect at the time the survey was completed in this case, unless otherwise stated.  In Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), an appellate panel of the Departmental Appeals Board (Board), after reviewing prior Board decisions, expressed a preference for applying the regulations in effect at the time of agency action rather than at the time of the events that were the basis for the agency action, at least in provider and supplier revocation cases.  In this case, the events that are the basis for the agency action occurred in 2015 and 2016, and the complaint investigation that is the basis for the agency action concluded on October 6, 2016.  The surveyor cited a violation of 42 C.F.R. § 483.65, which was the infection control regulation in effect throughout 2015 and through the end of the survey on October 6, 2016.  Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1 at 5.  The provisions of 42 C.F.R. § 483.65 were unchanged during the period of 2015 through completion of the survey.  Therefore, the regulation with which Petitioner was bound to comply during the period at issue, 2015 through completion of the survey on October 6, 2016, were the same.  However, effective November 28, 2016, the requirements related to infection control were moved to 42 C.F.R. § 483.80.  81 Fed. Reg. 68,688, 68,697 (Oct. 4, 2016).  The initial determination by CMS was issued on January 31, 2017.  CMS Ex. 20 at 1-5.  Therefore, the revised regulation effective November 28, 2016, would arguably apply under the Board's rationale in Kabat and cases cited therein.  The revision of the infection control regulation under 42 C.F.R. § 483.80 was significant.  At hearing, I advised the parties that I would apply the version of 42 C.F.R. § 483.65 in effect October 1, 2016.  The parties have not objected.  Tr. 99-100.  Due to the significant change in the infection control standard under 42 C.F.R. § 483.80, remand to CMS for revision of the Statement of Deficiencies (SOD) and a new initial determination was possible.  However, it is also possible to compare the provision of 42 C.F.R. § 483.65 and 42 C.F.R. § 483.80, and conclude that the participation requirement allegedly violated is found in both regulations.  The surveyor cited 42 C.F.R. § 483.65(a), (b), (c).  CMS Ex. 1 at 5-6.  Subsection (a) requires that a facility establish an infection control program to accomplish specific tasks.  Subsection (b) requires that a facility prevent the spread of infection by accomplishing specific tasks.  Subsection (c) has no application based on the allegations in the SOD.  Pursuant to 42 C.F.R. § 483.80(a), a facility must establish an infection control program and specific elements for such a program are listed.  Subsection (a) of 42 C.F.R. § 483.80 incorporates the provisions of 42 C.F.R. § 483.65(b) in substantial part.  Therefore, it is possible to simply read a citation to 42 C.F.R. § 483.65(a) and (b) as a citation to 42 C.F.R. § 483.80(a) without prejudice to either party, if that is deemed necessary.
• 2. The parties incorrectly stipulated that the CMP in this case ran through December 12, 2016.  Jt. Stip. ¶ 5.  However, the fact the state agency determined that Petitioner returned to substantial compliance effective December 12, 2016 (CMS Ex. 19 at 35-44), ended the accrual of the CMP effective December 11, 2016 (CMS Ex. 20 at 2).  42 C.F.R. § 488.440(b).
• 3. SNFs and NFs are often referred to as long-term care facilities or nursing homes.  Participation of a NF in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.
• 4. CMS increased the CMP amounts to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).
• 5. Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation similar to those of the HHS and SSA IGs, and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.
• 6. "Credible evidence" is evidence that is worthy of belief.  Black's Law Dictionary 596 (8th ed. 2004).  The "weight of evidence" is the persuasiveness of some evidence compared to other evidence.  Id. at 1625.
• 7. This is a "Tag" designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (http://www.cms.hhs.gov/Manuals/IOM/list.asp).  The "Tag" refers to the specific regulatory provision allegedly violated and CMS's policy guidance to surveyors.  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.  Ind. Dep't. of Pub. Welfare v. Sullivan, 934 F.2d 853 (7th Cir. 1991); Nw. Tissue Ctr. v. Shalala, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.
• 8. CMS and the state agency use scope and severity levels when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, Chap. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The scope and severity matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.
• 9. The CDC has issued numerous guidelines and recommendations that are potentially applicable in this case.  However, I consider only those offered as evidence by the parties.
• 10. P. Ex. 4 includes extracts from CMS Exs. 41 and 51.
• 11. CMS objected at hearing to characterizing the occurrence of active TB and latent TB infections at Petitioner as an outbreak.  Tr. 233.  Outbreak as used in this decision refers to the fact that the active and latent TB cases occurred in Petitioner's nursing home environment, suddenly, and unexpectedly; there is no evidence that TB usually occurred in Petitioner's facility; and there were multiple cases of active and latent TB.  The use of the term in this decision is consistent with Dr. Hodder's explanation of the meaning of the term as a term of art.  Tr. 686-88; CMS Ex. 53 at 41-42.  Under CMS guidance to surveyors, one case of an infection that is highly communicable, is an outbreak.  CMS Ex. 52 at 22.  TB is highly communicable and the occurrence of TB at Petitioner's facility is correctly referred to as an outbreak.
• 12. A contact investigation is the process of investigating potential contacts with one with active TB that was infectious or communicable, followed by testing to determine if those contacts were exposed to TB.  CMS Ex. 53 at 6, 17, 36-41.
• 13. Petitioner states there were about 19 (Tr. 142) or 20 residents who tested positive for TB exposure (PPFF ¶ 94).  CMS states there were only 19 (CPFF ¶ 39).  The SOD indicates that on about October 6, 2016, 20 residents were receiving treatment for latent TB infection.  CMS Ex. 1 at 7.  The SOD also alleges that 19 residents were identified as positive for latent TB in the initial round of testing in May 2015.  CMS Ex. 1 at 10.  P. Ex. 21 lists 26 residents identified in 2015 as exposed to TB and 18 of those are not listed as deceased when that document was prepared in 2016.  Counsel for Petitioner stated that there were 19 residents.  Tr. 142.  Petitioner's expert testified that there were 20 residents who tested positive for latent TB infection and received chest x-rays.  P. Ex. 31 at 11, 19.  The surveyor discusses only four residents in the SOD, Residents 1, 5, 6, and 7 (CMS Ex. 1 at 10-15), and CMS provided me only limited documentation from the clinical records of Residents 1 through 7.  There is no need to resolve the disparate numbers as there is no question that in May and June 2015, Petitioner had at least 19 residents who had been exposed to TB but who had not progressed to active TB as reflected by a positive skin test but a negative chest x-ray.  There is also no dispute that none of the 19 received prophylactic medication for latent TB infection between their identification in May 2015 and about August or September 2016 when treatment for latent TB infection began, except for Resident 4 whose case is discussed hereafter.  It would have been helpful to have a single, accurate listing of residents tested positive in 2015 by skin and blood tests and a similar list for those tested positive in 2016, with an indication of why residents do not appear on both lists.  It would have also been helpful to have a single exhibit that included copies of all test results, chest x-rays, and physician orders for treatment or copies of the residents' clinical records.  However, the absence of such detailed evidence does not prevent a decision in this case on the bases discussed hereafter.
• 14. Conversion refers to the undisputed fact that Resident 1 had latent TB infection and subsequently developed active TB.
• 15. 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.
• 16. Petitioner was not cited with noncompliance because its infection control policy was inadequate or due to inadequate care planning to treat and/or monitor latent TB infection.  However, the example of Resident 1 clearly shows why Petitioner's policy, at least as interpreted by DON Odunubi and ADON Hayden, was inadequate to prevent or control outbreaks for TB.  Resident 1 was identified in May 2015 by a positive TB skin test and negative chest x-ray as having a latent TB infection.  Resident 1 was not treated for latent TB infection and was formally evaluated in May 2016, a year after initial identification, and determined not to have converted to active TB.  One month later Resident 1 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 Resident 1's records did not clearly reflect the TB testing in 2015 and the latent TB infection, either by a clear diagnosis or a care plan for the latent TB infection.  If Petitioner's policy required clear documentation in resident records that the resident had a positive test and negative chest x-ray indicating probable latent TB infection, and a plan for treatment of latent TB and monthly assessments until the resident again tested negative for TB or the presence of latent TB infection was otherwise ruled out, Petitioner's policy would have much more effectively provided for the prevention and control of infections in the facility.
• 17. CDR Morris opined that the agreement between ADON Hayden and the county health department to delay treating the group identified in May 2015 as requiring treatment until the August 2015 group was identified so that all were treated as a cohort was acceptable.  CMS Ex. 49 at 53-54.  However, she also opined that the residents should have been diagnosed as having latent TB infections not later than September 2015.  She opined that all residents assessed as having latent TB infection should have been offered and treated for latent TB infection absent a contraindication that should have been documented in their clinical records.  CMS Ex. 42 at 12-15, 119.  My understanding of her opinions was that a delay in treatment until around September 2015, would be acceptable, but after that the risk for conversion was too great a threat.  I do not construe her opinions to be an endorsement of the delay in this case of nearly a year from September 2015 to August or September 2016.
• 18. Efforts have been made to discuss many theories and arguments in footnotes with some discussion to address their relative merit or lack thereof.  Theories advanced which are not discussed in this decision were not overlooked but simply found to merit no discussion.
• 19. Pages 2 through 4 of CMS Ex. 5 are surveyor notes, not part of Resident 1's clinical record.
• 20. The requirement for care planning moved to 42 C.F.R. § 483.21 effective November 28, 2016.  81 Fed. Reg. 68,688; 68,689; 68,737-43; 68,858.
• 21. Even if I found as fact that Petitioner's medical director did receive the recommendations for some of the residents with latent TB infection and failed to share them with other staff, it would not affect the outcome.  Similarly, if Petitioner's staff did receive the recommendations and simply failed to notify primary care physicians so that they could prescribe treatment, the outcome in this case would be no different.  Thus, under either scenario, receipt or non-receipt of recommendations are facts that are really immaterial.  See Fed. R. Evid. 401(b).  Petitioner would be no less liable for failure to follow its infection control policy in either case.
• 22. I recognize that Surveyor Slade did allege that immediate jeopardy began on June 14, 2016, which happened to be when Resident 1 had signs and symptoms that may have been consistent with, and Surveyor Slade seems to have determined were consistent with, the onset of active TB, even in the absence of a physician's diagnosis.  CMS Exs. 1 at 10-11; 43 at 3-5.  However, as discussed hereafter Petitioner has the burden to show that the declaration of immediate jeopardy was clearly erroneous, and Petitioner has failed to meet that burden.
• 23. Petitioner's policy is potentially confusing because it is not clear when "TB" is used whether it is a reference to active TB, infectious TB, or latent TB infection.
• 24. CMS also argues that Petitioner's annual monitoring for signs and symptoms of active TB (P. Ex. 21) was inadequate for residents with latent TB infection.  CMS Br. at 12-16.  Petitioner's policy provides that if a resident has a positive test for TB but a negative chest x-ray, the resident is to be monitored at least annually for signs and symptoms of active TB.  P. Ex. 6 at 4.  While I agree with CMS that annual monitoring is probably not adequate based on the evidence in this case, Petitioner was not cited because its infection control policy was inadequate.  CMS Ex. 1 at 5-15.  Furthermore, partial records of only seven residents with latent TB infection were placed in evidence and it is not possible to determine how much monitoring was actually done or not done.  Certainly, staff recorded signs and symptoms of Resident 1 in June and August 2016, that were consistent with active TB.  CMS Ex. 5 at 2, 43, 46-48, 55-58, 61, 62-72.  Therefore, staff was monitoring Resident 1 but simply failed to recognize and/or failed to advise the treating physician that Resident 1 may have had active TB in June and August 2016.  However, staff's failure is more symptomatic of a lack of competency and inadequate training than a failure to implement Petitioner's infection control policy.
• 25. CMS argues that Petitioner failed to ensure that Resident 1 received treatment for latent TB infection and suffered harm when she converted to active TB.  CMS Br. at 11-12.  CMS also argues that Petitioner failed to monitor Resident 1 for signs and symptoms of active TB to identify when she converted from latent to active TB; and Petitioner failed to timely diagnose and treat Resident 1's active TB.  CMS Reply at 2.  The argument CMS advances is really that Petitioner failed to deliver necessary care and services and or neglected Resident 1's care.  Those charges are not before me and are not considered bases for imposing enforcement remedies in this case.  Pursuant to 42 C.F.R. § 498.30, CMS had 12 months from the date of its January 31, 2017 notice of initial determination to reopen and revise that initial determination.  CMS failed to reopen and revise before January 31, 2018, to add new citations of noncompliance or to change the period and amount of the CMP.  CMS also argues Petitioner failed to isolate Resident 1 when she developed signs of active TB in June 2016.  CMS Reply at 2, 6-8.  There is no dispute that in June 2016, Petitioner's staff did not seem to recognize Resident 1's signs and symptoms were possibly consistent with active TB.  Therefore, there was no evidence of consideration of the need to isolate Resident 1 at that time and no violation of Petitioner's policy requiring isolation when there is suspected or confirmed TB.  This failure does not reflect a failure to implement Petitioner's infection control policy but, rather, a failure to ensure that Petitioner's staff was adequately trained and competent to recognize the signs and symptoms of active TB.
• 26. 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.  81 Fed. Reg. 68,688; 68,745.
• 27. Decisions often cited include:  Lakeport Skilled Nursing Ctr., DAB No. 2435 at 6 (2012); Liberty Health & Rehab. of Indianola, LLC, DAB No. 2434 at 13, 18-19 (2011); Yakima Valley Sch., DAB No. 2422 at 8; Lutheran Home at Trinity Oaks, DAB No. 2111 (2007); Daughters of Miriam Ctr., DAB No. 2067; Britthaven of Havelock, DAB No. 2078 (2007); Koester Pavilion, DAB No. 1750; Woodstock Care Ctr., DAB No. 1726.
• 28. The Board's characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttal presumption, is entirely consistent with the Supreme Court's characterization of the standard.  However, the Court's cautions about ensuring meaningful review rather than rubber-stamping agency decisions shows it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.
• 29. Appendix Q of the SOM in effect at the time of the survey in this case, also failed to provide surveyors a working definition of the term "serious" that they can use to determine whether harm, injury, or impairment is serious when deciding whether or not to declare immediate jeopardy.  The Act does not define the phrase "immediately jeopardize" and does not introduce the concept of serious harm, injury, or impairment as the basis for finding immediate jeopardy.  Thus, one is not in error concluding that absent a definition of the term "serious" in the Act, the regulations, the SOM, or decisions of the Board, it is essentially up to individual surveyors, and whatever unpublished guidance they receive from their superiors or CMS officials, to exercise their individual discretion and judgment to decide that there was immediate jeopardy, which subjects a facility to the maximum imposable CMPs.
• 30. The CMS initial determination issued January 31, 2017, included the determination that immediate jeopardy started on June 14, 2016.  CMS Ex. 20 at 2.  At hearing, counsel for CMS argued that June 14 was a typographical error and the inception of immediate jeopardy should have been June 4, 2016.  Tr.  56-57, 62.  CMS argued that on de novo review I should find that the evidence supported an inception of immediate jeopardy of June 4, 2016.  Tr. 56-57, 62.  I ruled at the hearing 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. 65‑66.  Pursuant to 42 C.F.R. § 498.30, CMS can only reopen and revise its initial determination within 12 months of the date on the notice of the initial determination.  Counsel raised this issue for the first time during the first day of hearing on July 16, 2018, more than a year after the date of the initial determination and too late for CMS to reopen and revise its initial determination.  Tr.  66-67.
• 31. I recognize that CMS did not charge Petitioner for either failure to deliver necessary care and services or neglect.  I consider only the practical effect of Petitioner's action.