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                              Presbyterian Village, DAB CR5849 (2021)
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Presbyterian Village, DAB CR5849 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





Presbyterian Village
(CCN: 11-5490),
Petitioner,

v.

Centers for Medicare & Medicaid Services.
Docket No. C-17-511Decision No. CR5849April 8, 2021

        
              
    

      DECISION

Following a survey by the Georgia Department of Community Health (state agency), the Centers for Medicare & Medicaid Services (CMS) concluded that Presbyterian Village (Petitioner or the facility) was not in substantial compliance with Medicare program participation requirements codified at 42 C.F.R. §§ 483.80(a)(1), (a)(2), (a)(4), (e), (f) and 483.70.1
  CMS concluded that Petitioner failed to respond adequately to an outbreak of viral gastroenteritis (norovirus) at its facility.  CMS determined that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety and imposed a civil money penalty (CMP) of $10,841 per day for eleven days (from January 13, 2017, through January 23, 2017).  CMS determined Petitioner returned to substantial compliance as of February 8, 2017.2
  Petitioner requested a hearing to challenge CMS’s

**Page 2**

findings and the remedies imposed.  For the reasons discussed below, I find that Petitioner failed to comply substantially with the Medicare participation requirements found at 42 C.F.R. §§ 483.80(a)(1) and 483.70.  However, I find that Petitioner’s noncompliance was first evident on January 16, 2017, rather than January 13, 2017, as CMS found.  For the period January 16, 2017, through January 23, 2017, I find that Petitioner’s noncompliance posed immediate jeopardy to its residents.  Finally, I conclude that the CMP amount is reasonable.

I.        Background and Procedural History

Petitioner is a skilled nursing facility (SNF) located in Austell, Georgia, that participates in the Medicare program.  *See, e.g.*, CMS Exhibit (Ex.) 5 at 1.  The state agency conducted a recertification survey of Petitioner’s facility from January 17, 2017, through January 20, 2017.  *Id*.  Based on the survey findings, the state agency concluded that Petitioner was not in substantial compliance with 42 C.F.R. §§ 483.80(a)(1), (a)(2), (a)(4), (e), (f) (Tag F441) and 483.70 (Tag F490).3
  *Id.* at 2-3.  The facility’s noncompliance was cited at a scope and severity level “K.”4
  *Id*.  CMS concurred with the state agency’s determination and, by letter dated February 1, 2017, imposed a CMP of $10,841 per day from January 13, 2017, through January 23, 2017, and a Denial of

**Page 3**

Payment for New Admissions (from February 3, 2017, through February 7, 2017).  CMS Ex. 9 at 1-3; *see also* CMS Ex. 38 at 2-4; CMS Ex. 42.  CMS determined that the facility returned to substantial compliance effective February 8, 2017.  CMS Ex. 42 at 1.

Petitioner timely requested a hearing before an administrative law judge.  The case was assigned to me for hearing and decision.  On April 5, 2017, I issued an Acknowledgment and Pre-Hearing Order (Pre-Hearing Order) establishing a briefing schedule.  In compliance with my Pre-Hearing Order, CMS filed a pre-hearing exchange, consisting of a pre-hearing brief (CMS Br.) and 45 proposed exhibits, including the written declarations of two proposed witnesses (CMS Exs. 1-45).  Petitioner filed a pre‐hearing exchange, consisting of a pre‐hearing brief (P. Br.) and 111 proposed exhibits, including the written declarations of ten proposed witnesses (P. Exs. 1-111).

CMS did not object to any of Petitioner’s proposed exhibits.  Petitioner objected to CMS exhibits 26, 27, 44, and 45 because they include hearsay.  Petitioner additionally objected to CMS Ex. 44 on the basis that it includes improper opinion testimony.  Following a telephone prehearing conference with the parties, I overruled Petitioner’s objections to CMS Exs. 26 and 27.  In an order issued April 16, 2018, I noted that hearsay is admissible in administrative proceedings before the Civil Remedies Division.  42 C.F.R. § 498.61 (“Evidence may be received at the hearing even though inadmissible under the rules of evidence applicable to court procedure.”).  I further noted that I would disregard any testimony that purports to opine on the ultimate legal issues that are reserved for my decision.

On May 21 and 22, 2018, I held a hearing via video-teleconference (VTC), and a transcript (Tr.) was made of the proceeding.  I presided from the Departmental Appeals Board office in Washington, D.C.  Counsel for each party and the witnesses (with one exception) appeared via VTC from Atlanta, Georgia.  Howard W. Reese, III, Esq., and J. Felicia LeRay, Esq., represented Petitioner.  Michelle Gilliam, Esq., Assistant Regional Counsel, represented CMS.  I admitted CMS Exs. 1-45 and P. Exs. 1-111.  *See*Tr. at 14, 28, 55, 136, 179, 213, 230, 280, 330, 367, 383,  449, 479.  During the hearing, counsel for Petitioner cross-examined Ms. Ginnie Campbell, a former employee of the Cobb & Douglas County Public Health Department (CDPH) and Ms. Joy Shepherd, a state agency surveyor.  Counsel for CMS cross-examined Petitioner’s co-medical directors, Dr. R. Elliot Jackson and Dr. Charles D. Markle; Petitioner’s administrator, Ms. Carolyn Hardy; Petitioner’s Director of Nursing (DON), Nichelle Buckles; Petitioner’s former Assistant DON and Infection Control Nurse, Lud Harris; and Tomeka Davis, a nurse who worked occasionally at Petitioner’s facility.  CMS also cross-examined Petitioner’s expert witnesses:  Bruce Robinson, M.D., M.P.H.; Benjamin Lopman, Ph.D., MSc; and Zandraetta Tims-Cook, M.D., M.P.H.

Following the hearing, each party submitted a post-hearing brief (CMS Posthrg. Br.; P. Posthrg. Br.) and a reply brief (CMS Reply; P. Reply).

**Page 4**

II.       Issues

The issues in this case are:

Whether Petitioner was in substantial compliance with Medicare participation requirements at 42 C.F.R. §§ 483.80(a)(1), (a)(2), (a)(4), (e), (f) (Tag F441) and 483.70 (Tag F490); and, if not,

Whether CMS’s determination that the noncompliance represented immediate jeopardy to resident health and safety was clearly erroneous; and, if not,

Whether the CMP of $10,841 per day is reasonable.

III.     Jurisdiction

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

IV.     Discussion

**A. Statutory and Regulatory Background**

The Act sets requirements for SNFs to participate in the Medicare program and authorizes the Secretary of Health & Human Services (Secretary) to promulgate regulations implementing those statutory provisions.  Act § 1819 (42 U.S.C. § 1395i-3).  The Secretary’s regulations are found at 42 C.F.R. parts 483 and 488.

To participate in the Medicare program, a SNF must maintain substantial compliance with program requirements.  To be in substantial compliance, a SNF’s deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  A deficiency is a violation of a participation requirement established by section 1819(b)-(d) of the Act (42 U.S.C. § 1395i-3(b)-(d)), or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  *Id.*  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  *Id.*

The Secretary contracts with state agencies to conduct periodic surveys to determine whether SNFs are in substantial compliance with the participation requirements.  Act § 1864(a) (42 U.S.C. § 1395aa(a)); 42 C.F.R. § 488.10.  The Act also authorizes the Secretary to impose enforcement remedies against SNFs that do not comply with the participation requirements.  Act § 1819(h)(2) (42 U.S.C. § 1395i-3(h)(2)).  The regulations specify the enforcement remedies that CMS may impose if a facility is not in substantial compliance.  42 C.F.R. § 488.406.  Among other enforcement remedies, CMS

**Page 5**

may impose a CMP for each day that a facility is not in substantial compliance.  42 C.F.R. § 488.430(a).  The regulations authorize CMS to impose a CMP within the range of $6,291 to $20,628 per day for deficiencies that pose immediate jeopardy to a facility’s residents. 5
  42 C.F.R. § 488.438(a)(1); 45 C.F.R. § 102.3.

If CMS imposes a remedy, such as a CMP, based on a noncompliance determination, then the facility may request a hearing before an administrative law judge to determine whether there is a basis for the deficiency findings that led to the imposition of the remedy and whether the CMP imposed is reasonable.  Act §§ 1128A(c)(2) (42 U.S.C. § 1320a-7a(c)(2)), 1819(h)(2)(B)(ii) (42 U.S.C. § 1395i-3(h)(2)(B)(ii)); 42 C.F.R. §§ 488.408(g), 488.434(a)(2)(viii), 498.3(b)(13).  However, the facility may not appeal CMS’s choice of remedies.  42 C.F.R. § 488.408(g)(2).

CMS has the burden to come forward with evidence sufficient to make a *prima facie* showing that Petitioner is out of substantial compliance with participation requirements to establish a basis to impose an enforcement remedy.  *See, e.g., Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7 (2007).  If CMS makes this *prima facie* showing, then Petitioner bears the ultimate burden of persuasion as to whether it substantially complied.  In other words, Petitioner must show, by a preponderance of the evidence, on the record as a whole, that it was in substantial compliance with participation requirements.  *Id*.  Petitioner has both the burden of coming forward and the burden of persuasion as to any affirmative defense.  *Id.*; *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004), *aff’d sub nom.*,*Batavia Nursing & Convalescent Ctr.* *v. Thompson*, 129 F. App’x 181 (6th Cir. 2005).

In the present case, CMS alleged that Petitioner failed to comply substantially with 42 C.F.R. § 483.80(a)(1), (a)(2), (a)(4), (e), and (f).  The regulation requires:

The facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.
     (a) Infection prevention and control program. The facility must establish an infection prevention and control program (IPCP) that must include, at a minimum, the following elements:
          (1) A system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under a contractual arrangement based upon

**Page 6**

the facility assessment conducted according to § 483.70(e) and following accepted national standards;
          (2) Written standards, policies, and procedures for the program, which must include, but are not limited to:
                (i)  A system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility;
                (ii) When and to whom possible incidents of communicable disease or infections should be reported;
                (iii) Standard and transmission-based precautions to be followed to prevent spread of infections;
                (iv) When and how isolation should be used for a resident; including but not limited to:
                      (A) The type and duration of the isolation, depending upon the infectious agent or organism involved, and
                      (B) A requirement that the isolation should be the least restrictive possible for the resident under the circumstances.
                (v) The circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease; and
                (vi) The hand hygiene procedures to be followed by staff involved in direct resident contact.

*          *          *

(4) A system for recording incidents identified under the facility’s IPCP and the corrective actions taken by the facility.

*          *          *

(e) Linens. Personnel must handle, store, process, and transport linens so as to prevent the spread of infection.
     (f) Annual review. The facility will conduct an annual review of its IPCP and update their program, as necessary.

CMS also alleged that the facility failed to comply substantially with 42 C.F.R. § 483.70, which requires:

A facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

**Page 7**

**B.  Findings of Fact, Conclusions of Law, and Analysis**

***1.   I find the following facts by a preponderance of the evidence.***

**Petitioner’s Policies and Procedures**

The state agency surveyors alleged that Petitioner did not have an infection control policy in place at the time of the survey.  *See, e.g.,*CMS Ex. 5 at 4-5.  However, Petitioner offered credible testimony that it had in place policies and procedures for infection control and response to viral outbreaks that had been created prior to January 2017, and had been continuously in effect for a number of years.6
  *See, e.g.,*P. Ex. 65 at ¶ 14; P. Ex. 66 at ¶ 11; P. Ex. 67 at ¶ 5; P. Ex. 70 at ¶¶ 3-4; Tr. at 250, 259-60, 264, 404, 420, 470.  I therefore find that Petitioner had a written policy, titled “Gastroenteritis,” that was in effect at the time of the survey (Gastroenteritis Policy).  *See*P. Ex. 1.

Petitioner’s Gastroenteritis Policy began with the following general information:

Gastroenteritis is inflammation of the lining of the stomach and intestines, and usually causes nausea, vomiting, and/or diarrhea.  Illnesses that cause nausea and diarrhea are often referred to as the “stomach flu”.  **Noroviruses** may account for more than 90% of gastroenteritis outbreaks not caused by bacteria or toxins.

*Id.* at 1(bold type added).  The policy provided the following criteria to define a “case” that should be treated as part of a suspected norovirus outbreak:

Vomiting and/or diarrhea (two or more loose stools in a 24-hour period) in a resident or staff member with onset of symptoms since

**Page 8**

(specified date) and whose symptoms have no other apparent cause [such as a new medication or laxative or pre-existing health condition].

*Id.* The Gastroenteritis Policy required the following actions, among others:  “As soon as an outbreak is suspected, the Nursing Supervisor or Designee should contact the Director of [N]ursing, the Administrator and then the Public Health Department.”  *Id.*at 2.

The Gastroenteritis Policy noted that the viruses are easily transmitted from person to person, and that “[p]eople are most contagious from the moment they begin feeling ill until diarrhea subsides; however they can remain contagious for at least two days after recovery.”  *Id.*at 1.  Given the danger of person-to-person transmission, the Gastroenteritis Policy required “[p]rompt exclusion/isolation of affected individuals” and elaborated as follows:

Exclusion or isolation is a vital measure in outbreak control.  Every effort should be made to keep any symptomatic (ill) individual excluded/isolated until 48 hours after normal bowel habits have returned and any vomiting has stopped – the ‘48-hour rule’.[7
]

*          *          *

In general . . . it is important that people with symptoms are kept apart from those who do not have symptoms.

*Id.*at 2.

The Gastroenteritis Policy included the following instructions for disinfection:

Noroviruses are resistant to many commonly used disinfectants, including quaternary ammonium compounds that are often used in health care facilities.  During an outbreak it is important to use a 5000 ppm bleach solution effective against norovirus (one cup of household bleach in one gallon of water . . .) or a disinfectant approved by EPA with specific claims for activity against noroviruses.

*Id.*at 1.

**Page 9**

Petitioner also had a related policy, titled “Isolation Policies and Procedures” (Isolation Policy).  P. Ex. 36.  I find it more likely than not that Petitioner’s Isolation Policy was in effect at the time of the survey.  The Isolation Policy stated that contact precautions apply to residents who may have norovirus.  *Id.*at 1.  According to the policy, contact precautions included the following elements:

**PPE** [Personal Protective Equipment] **use**
     a. Wear gloves when touching the resident and the resident’s immediate environment or belongings.
     b. Wear a gown if substantial contact with the resident or the resident’s environment is anticipated.
     c. Perform hand hygiene before entering the room and after removal of PPE.  Use soap and water when hands are visibly soiled (for example, with
         blood, body fluids), or after caring for residents with known or suspected infectious diarrhea (for example, *Clostridium difficile*, norovirus).

**Resident placement**
A single room is preferable.  Cohort only with residents who are affected by the same organism.

**Resident transport**
Limit the movement and transport of the resident from the room for essential purposes only.  Where necessary ensure that adequate precautions are taken to minimize the risk of transmission to others, and contamination of environmental surfaces or equipment.

**Resident care equipment**
Where possible dedicate the use of resident care equipment to a single resident.  Otherwise, ensure that all items are adequately cleaned or disinfected before use for another resident.

*Id.*at 1-2.

Petitioner’s policies were generally consistent with the “Recommendations for Controlling an Outbreak of Viral Gastroenteritis in a Long Term Care Facility” fact sheet that was provided to the facility by CDPH.  *See*CMS Ex. 21 at 5-8; *see also*CMS Ex. 44 at ¶ 7.  For example, the CDPH recommendations included:

Immediately call a Board of Health epidemiologist . . . when two or more residents or staff begin experiencing vomiting and/or diarrhea within a three‐day period. . .**Page 10**

Promptly isolate residents with gastrointestinal symptoms (vomiting, diarrhea, fever and/or abdominal pain).  Keep ill residents in their rooms for 72 hours after vomiting and/or diarrhea cease.*          *          *

Restrict visitation. . . .
	Ensure that residents and staff wash their hands more often than usual. . . .*          *          *

Consider closing the dining room and serving meals to residents in their rooms.*          *          *

Ensure staff are using precautions when caring for a patient with an active gastrointestinal illness, including wearing gowns, gloves and a mask.*          *          *

Maintain a log of sick residents and staff. . . . Provide updates to the Board of Health as requested.*          *          *

It is extremely important to use a [disinfectant] product that is effective against norovirus.
	A chlorine bleach solution is the recommended disinfectant.CMS Ex. 21 at 5-7.

**Events of January 13-16, 2017**

On January 13, 2017, three of Petitioner’s residents experienced nausea, vomiting, and diarrhea.  *See, e.g.,* CMS Ex. 24 at 1; P. Ex. 67 at ¶ 7.  The same day, two additional residents experienced diarrhea.  *Id.* No additional residents experienced gastrointestinal symptoms on January 14, 2017.  However, on January 15, 2017, five additional residents experienced nausea, vomiting, and diarrhea, or some combination of these symptoms.  *Id.* On January 16, 2017, eight additional residents experienced gastrointestinal symptoms.  *Id.*at 1-2.

**Page 11**

Petitioner’s expert witness, Bruce Robinson, M.D., M.P.H., testified that it is not possible to identify an outbreak of viral gastroenteritis on the first day patients get sick.  Tr. at 189-90.  According to Dr. Robinson, this is because there are any number of diagnoses in addition to viral gastroenteritis that may cause vomiting and diarrhea in a frail elderly population.  *Id.*at 188-89.  Dr. Robinson’s testimony is consistent with other expert testimony from Benjamin Lopman, Ph.D., MSc, and Zandraetta Tims-Cook, M.D., M.P.H.  Dr. Lopman testified that an outbreak of viral gastroenteritis is characterized by several patients experiencing multiple episodes of vomiting or diarrhea within 48 to 72 hours of one another.  Tr. at 304; *see also*P. Ex. 59 at 7 (¶ 8).  Similarly, Dr. Tims-Cook testified that it would have been “impossible” during the initial window to realize that anything out of the ordinary was happening.  Tr. at 351-52; *see also*P. Ex. 61 at ¶ 7.  She went on to explain, “[Y]ou can’t define an outbreak in one day.”  Tr.at 352.  Rather, according to Dr. Tims-Cook, identifying an outbreak involves “a number [of cases] that exceeds what is expected and over a certain duration.”  *Id*.  The testimony of the experts is credible and unrebutted on the record.8
  I therefore find that it was not possible for Petitioner to have identified an outbreak of viral gastroenteritis on January 13, 2017.

On the other hand, the medical professionals who expressed an opinion agreed that, by January 16, 2017, there was sufficient information to conclude that Petitioner was experiencing an outbreak.  For example, Dr. Tims-Cook testified that, by Sunday evening (January 15, 2017) or Monday (January 16, 2017) it was appropriate to recognize an outbreak.  Tr. at 341; *see also id.*at 236 (based on record review, DON thought cases began to be suspicious for an outbreak on January 15, 2017).  Similarly, R. Elliot Jackson, M.D., one of Petitioner’s co-medical directors, testified that, as of January 16, 2017, it was apparent that Petitioner was experiencing an outbreak of a gastrointestinal illness.  Tr. at 140-41, 148-50.  In addition, Charles D. Markle, M.D., Petitioner’s other co‐medical director, testified that on January 16, 2017, one of Petitioner’s nurses informed him that the facility was experiencing an outbreak of gastrointestinal illness.  *Id.*at 218-220; *see also*P. Ex. 67 at ¶ 11 (“[o]n January 16, 2017, Drs. Markle and Jackson . . . made a decision that we were experiencing a viral gastroenteritis outbreak at the facility”).  Consistent with his and Dr. Jackson’s determination, Dr. Markle developed standing orders to treat any of his patients who developed symptoms consistent with

**Page 12**

gastroenteritis.  P. Ex. 65 at ¶ 12; *see also*CMS Ex. 29 at 7.  Dr. Markle’s orders included clear liquids, contact precautions, monitor temperature, and isolation.9
  P. Ex. 65 at ¶ 12.  I therefore find that, as of January 16, 2017, Petitioner’s staff and co-medical directors were aware that the facility was experiencing an outbreak of viral gastroenteritis.

January 16, 2017, was Martin Luther King, Jr. Day, a national holiday.  *See, e.g.*, P. Ex. 68 at ¶ 6.  Although it was a holiday, Carolyn Hardy, Petitioner’s administrator, was at the facility.  *Id.*at ¶ 5.  On January 16, in response to the gastroenteritis outbreak, Petitioner’s staff posted signage to restrict visitation, and management made the decision to cease admitting new residents.  *Id.*at ¶ 6; *see also*CMS Ex. 29 at 6.  Petitioner’s nursing staff had already begun isolating residents who were symptomatic.  P. Ex. 68 at ¶ 5.  Ms. Hardy testified that Petitioner “continued to implement [its] infection control policies and procedures, and followed [its] infection prevention and control program.”  *Id.*at ¶ 6.  However, no member of Petitioner’s staff reported the gastroenteritis outbreak to state or county public health officials on January 16, 2017.  *See id.*at ¶¶ 8, 9.

Petitioner’s staff apparently believed it was not possible to report an outbreak of viral gastroenteritis to public health officials on January 16, 2017, because it was a holiday.  *See, e.g.*,P. Ex. 67 at ¶ 11 (facility was “unable to report on January 16, [2017] because it was a national holiday, and the public health department was closed”).  However, this was incorrect.  Ginnie Campbell, who at the time was a disease surveillance nurse for CDPH, testified that facilities are able to report outbreaks “using Georgia’s toll-free 24‐hour telephone number . . . or online through the SendSS (State Electronic Notifiable Disease Surveillance System . . . .”10
  CMS Ex. 44 at ¶ 6.  Ms. Campbell further testified that this contact information is available on both the state and county public health websites.  *Id.* Yet, Petitioner’s staff reported the outbreak, at the earliest, on January 18, 2017.11

**Page 13**

**Events of January 17-20, 2017**

*Activities of Petitioner’s staff*

Petitioner’s Quality Assurance Committee met on January 17, 2017.  P. Ex. 68 at ¶¶ 10, 11; *see also*P. Ex. 58.  Following the meeting, Petitioner’s staff decided to suspend group activities facility-wide and initiated increased rounds by housekeeping.  P. Ex. 68 at ¶ 11.

Lud Harris, who was Petitioner’s Infection Control Nurse at the time, testified that she called CDPH and left a message for Ginnie Campbell around lunchtime on January 18, 2017.  Tr. at 463, 468-69.  Ms. Harris also testified that the telephone log showed a call from her office to Ms. Campbell's number on that date.  *Id.*at 469.  Tomeka Davis, a nurse who also worked at Petitioner’s facility from time to time, testified that she had spoken to Ms. Campbell on January 18, 2017, and that Ms. Campbell told Ms. Davis that she had received a message from Ms. Harris earlier that day.  *Id.*at 374.  I find the testimony of Ms. Harris and Ms. Davis credible.  Based on their testimony, I find it more likely than not that, on January 18, 2017, Ms. Harris attempted to notify CDPH of a possible outbreak of viral gastroenteritis at Petitioner’s facility by leaving a voicemail message for Ms. Campbell.

*Activities of state agency surveyors*

On January 17, 2017, state agency surveyors arrived at Petitioner’s facility to conduct a recertification survey.  *See*CMS Ex. 5 at 1; *see also*Tr. at 55-56.  When the surveyors arrived at the facility, a staff member informed them that “there was something going on” at the facility and that residents were in isolation.  Tr. at 56.  The surveyors also observed signs posted on the front door of the building, warning of “an outbreak of a GI [v]irus” and asking visitors to refrain from visiting. *Id.*at 57-58; *see also*CMS Ex. 29 at 6.  The surveyors contacted their supervisor, who instructed them to proceed with the survey.  Tr. at 58.

While the surveyors were onsite at Petitioner’s facility, they observed that several residents who experienced gastrointestinal symptoms were not kept isolated from other residents.  For example, on January 18, 2017, at 5:10 p.m., a surveyor observed Resident

**Page 14**

# 51 watching television in the day room.  CMS Ex. 5 at 18.  Resident # 51 began experiencing symptoms on January 16 and her symptoms ended on January 17.  *Id.*; *see also*CMS Ex. 24 at 4.  January 18 was neither 48 nor 72 hours after Resident # 51 was no longer experiencing symptoms.  Similarly, on January 20, 2017, at 10:42 a.m. and 3:30 p.m., a surveyor observed that Resident # 11 was sitting in a common area with other residents, although she had experienced diarrhea on January 18, 2017.  CMS Ex. 5 at 15.

On January 18, 2017, at 5:00 p.m., a surveyor observed a Certified Nursing Assistant (CNA) wearing gloves, but not a gown, go into Resident # 17’s room with a bath basin.  *Id.*at 16.  Resident # 17 had symptoms of the gastrointestinal illness beginning on January 18, 2017.  *Id*. at 15-16. Resident # 17 later tested positive for norovirus.  *Id.*at 16*.*  In addition, in an interview on January 18, 2017, a CNA told the surveyor that, although Resident # 11 had diarrhea on January 18, the CNA had provided care wearing gloves, but had not worn a gown or mask.  *Id.*at 15.  Also, in an interview on January 18, 2017, one of Petitioner’s LPNs stated that she cared for a resident with active symptoms (Resident # 107) wearing gloves, but had not used a gown.  *Id.*

In an interview on January 20, 2017, one of Petitioner’s housekeepers told a surveyor that she uses a product she identified as GenEon for cleaning and disinfecting.  CMS Ex. 5 at 10.  Surveyors later learned from CDPH that GenEon is not on the Environmental Protection Agency’s (EPA’s) list of products certified as effective against norovirus.  *Id.*at 23; *see also*CMS Ex. 21 at 13-14.

***2.   Beginning on January 16, 2017, Petitioner failed to comply substantially with 42 C.F.R. § 483.80(a)(1) because it did not effectively maintain its infection control policy during a norovirus outbreak at the facility.***

In January 2017, Petitioner had in place a number of policies bearing on infection control during a gastrointestinal virus outbreak.  *See, e.g.,* P. Exs. 1, 7, 9, 14, 16, 18, 24, 36.  Petitioner followed some – but not all – of the steps required by its policies.  A facility’s policies may represent standards by which the facility is bound.  *See, e.g., Ill. Knights Templar Home*, DAB No. 2369 at 9-10 (2011); *see also**Perry Cnty. Nursing Ctr.*, DAB No. 2555 at 9 (2014) (“it is ‘reasonable to presume’ that [a facility’s own] policies reflect professional standards of quality” (quoting *Sheridan Health Care Ctr.*, DAB No. 2178 at 32 (2008)).  Had Petitioner’s staff implemented its existing policies fully, it is likely that Petitioner would have substantially complied with Medicare participation requirements.  However, Petitioner did not do so.  Petitioner did not timely report the outbreak to public health officials.  Petitioner did not fully implement contact isolation procedures when caring for residents who became ill.  Petitioner did not ensure that all ill residents were kept apart from well residents.  Finally, Petitioner was not using bleach or another cleaning agent identified by the EPA as effective against norovirus.

**Page 15**

With regard to Petitioner’s obligation to report the outbreak of viral gastroenteritis to public health officials, Petitioner’s Gastroenteritis Policy directed Petitioner’s staff to report to the Public Health Department “[a]s soon as an outbreak is suspected.”  P. Ex. 1 at 2.  As I have found above, members of Petitioner’s nursing staff, as well as its co‐medical directors, determined that the facility was experiencing an outbreak as of January 16, 2017.  Yet, it is undisputed that the *earliest*any member of Petitioner’s staff attempted to report the outbreak was on January 18, 2017, when Ms. Harris left a message for Ms. Campbell at CDPH.  Ms. Harris was apparently under the mistaken impression that it was not possible to report an outbreak on January 16, 2017, because it was a holiday.  *See*P. Ex. 67 at ¶ 11.  But, even if Ms. Harris did not know of the options for reporting online or via the toll-free number, Petitioner has made no showing that it could not have reported to CDPH on January 17, 2017, which was a regular work day.  I therefore find that Petitioner did not report the outbreak promptly, as its own policy required.  Because Petitioner did not report the outbreak until January 18, 2017, CDPH did not begin to provide support in managing the outbreak until on and after that date.  *See, e.g.,*CMS Ex. 21.  For example, CDPH did not obtain stool samples from Petitioner to test for norovirus until January 20, 2017.  CMS Ex. 44 at ¶ 9.  Three residents and one staff member tested positive for norovirus.  *Id.*; *see also*CMS Ex. 30.

Further, Petitioner did not keep affected residents separated from unaffected residents as its Gastroenteritis Policy required.  Petitioner’s policy provided:

Exclusion or isolation is a vital measure in outbreak control.  Every effort should be made to keep any symptomatic (ill) individual excluded/isolated until 48 hours after normal bowel habits have returned and any vomiting has stopped – the ‘48-hour rule’.

P. Ex. 1 at 2.  However, the state agency surveyors observed several residents in common areas before 48 hours had passed after symptoms subsided.12
  CMS Ex. 5 at 15, 18.  In addition, Petitioner did not suspend communal dining during the outbreak.  Tr. at 431.

Moreover, Petitioner did not fully implement its Isolation Policy.  For example, Petitioner’s policy directed staff to “[w]ear a gown if substantial contact with the resident or the resident’s environment is anticipated.”13
  P. Ex. 36 at 1.  However, surveyors

**Page 16**

observed and were told that Petitioner’s staff did not wear gowns when providing care to affected residents.  CMS Ex. 5 at 15-16.

Petitioner points to the testimony of Dr. Lopman as proof that it effectively implemented its infection control policy.  *See*P. Posthrg. Br. at 2-3; P. Reply at 2.  Dr. Lopman testified that, in statistical terms, the duration of the norovirus outbreak at Petitioner’s facility was “on the shorter end of the distribution of how long norovirus outbreaks can occur.”  Tr. at 316.  He went on to opine that, based on the duration of the outbreak, there was probably not “ongoing environmental contamination resulting in subsequent cases.”  *Id.* I find Dr. Lopman’s testimony on the characteristics of the outbreak in comparison with the statistics on outbreaks credible.  Nevertheless, his testimony does not contradict the observations of the surveyors as a factual matter.

For all these reasons, Petitioner did not implement its own policies for infection control during the January 2017 gastroenteritis outbreak.  It therefore failed to maintain an effective infection control program as required by 42 C.F.R. § 483.80(a)(1).14
  Petitioner’s noncompliance was substantial because it had the potential to cause more than minimal harm.  Dr. Lopman and Ms. Campbell both testified that gastroenteritis can be serious for the elderly and those with comorbidities.  For example, Dr. Lopman opined that, for institutionalized elderly, gastroenteritis “may progress to more severe or prolonged illness and, occasionally, death.”  P. Ex. 59 at 3 (¶ 5).  Similarly, Ms. Campbell testified that repeated vomiting and diarrhea can lead to dehydration, which may require therapy with intravenous fluids.  CMS Ex. 44 at ¶ 5.  She further testified that, in severe cases, patients with gastroenteritis may require hospitalization.  *Id.* In some severe cases gastroenteritis may lead to death.  *Id.*

***3.   Petitioner was not in substantial compliance with 42 C.F.R. § 483.70 because its administration did not ensure that the facility’s infection control policy was carried out effectively.***

The Medicare participation requirement for administration requires that “[a] facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident.”  42 C.F.R. § 483.70.  For many of the same reasons described in

**Page 17**

the previous section of this decision, I find that Petitioner did not comply substantially with this requirement.  Petitioner’s response to the outbreak of viral gastroenteritis at its facility was not coordinated or consistent.  Although, as I have found above, Petitioner had in place policies and procedures for addressing such an outbreak, its staff members were not familiar with the requirements of the policy and, therefore, did not implement it fully.  This is perhaps understandable because it appears that the outbreak of January 2017 was the first such incident several of Petitioner’s management team had ever experienced.  *See, e.g.,*Tr. at 409-10 (Petitioner’s administrator had no prior experience of a reportable disease); *see also id.*at 465 (Infection Control Nurse had never had occasion to report before).  Moreover, the outbreak began to manifest over a holiday weekend.  Therefore, Petitioner’s full-time managers were not on duty.  *See id.*at 234, 393-94, 457 (DON, Infection Control Nurse did not work January 14-16, 2017; administrator was working on January 16, 2017).  Finally, the arrival of the surveyors on January 17, 2017, created an additional distraction.  *See id.*at 398; *see also*P. Ex. 63 at ¶ 10 (surveyors interviewing facility employees pulls employees away from their primary duties and makes responding to an outbreak “impossible”).

Yet, even allowing for the fact that several factors may have made it more challenging for Petitioner’s staff to respond to the outbreak, it was Petitioner’s responsibility to ensure that staff followed the proper protocols, even under difficult circumstances.  I infer that Petitioner did not substantially comply with 42 C.F.R. § 483.70 because Petitioner’s staff appeared to be unfamiliar with Petitioner’s policies for dealing with an outbreak of viral gastroenteritis in several key respects.  First of all, Petitioner’s administrator was not herself aware of the facility’s obligation to report the outbreak to public health officials, nor did she check to determine whether any such requirement existed.  *See*Tr. at 400, 426.  If the administrator herself was unaware of the obligation, it is difficult to see how she could ensure that the facility fulfilled the requirement.  While there is some suggestion that Ms. Hardy relied on Petitioner’s clinical staff to carry out this duty (*id.*at 426), their knowledge of the reporting requirement was inadequate as well.

For example, Petitioner’s Infection Control Nurse did not report the outbreak as soon as it was suspected, as I have found above.  Indeed, Ms. Harris herself did not know at the time that she could report an outbreak via facsimile to the local public health department.  *Id.*at 466.  Moreover, even as of the date of the hearing, Ms. Harris was unaware of the options for 24-hour reporting.  *Id.*at 467.  The fact that the staff member primarily responsible for infection control at Petitioner’s facility was unfamiliar with these requirements leads me to conclude that there was a failure in Petitioner’s administration.

Further, Petitioner’s administration did not ensure that staff kept residents who were ill in their rooms until at least 48 hours after their symptoms subsided.  *See*CMS Ex. 5 at 15, 18.  Petitioner offered some testimony suggesting that it could not confine residents to their rooms short of restraining them, which would violate the residents’ rights.  *See,*

**Page 18**

*e.g.,*Tr. at 197-98.  However, Petitioner made no showing that staff even attempted to redirect ill residents to their rooms when they entered common areas.

Finally, Petitioner’s direct care staff did not seem to be familiar with all aspects of Petitioner’s Isolation Policy, particularly with regard to the use of personal protective equipment.  As I have described above, Petitioner’s policy required staff to use gowns “if substantial contact with the resident or the resident’s environment is anticipated.”  P. Ex. 36 at 1.  Despite the existence of this policy, some of Petitioner’s staff did not use gowns when caring for residents affected by the viral gastroenteritis outbreak.15
  CMS Ex. 5 at 15‐16.

For all these reasons, I conclude that Petitioner did not comply substantially with 42 C.F.R. § 483.70.  Having concluded that Petitioner failed to comply with Medicare participation requirements, I next consider whether CMS’s determination that Petitioner’s noncompliance posed immediate jeopardy to resident health and safety was clearly erroneous.

***4.   CMS did not clearly err in determining that Petitioner’s noncompliance represented immediate jeopardy to resident health and safety from January 16, 2017, through January 23, 2017.***

Immediate jeopardy exists if a facility’s noncompliance has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.  42 C.F.R. § 488.301.  I must uphold CMS’s determination as to the level of a facility’s substantial noncompliance (which includes an immediate jeopardy finding) unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The “clearly erroneous” standard imposes on facilities a heavy burden to overcome a finding of immediate jeopardy.  Appellate panels of the DAB have sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  *See, e.g.*, *Barbourville Nursing Home*, DAB No. 1962 at 11 (2005) (quoting *Florence Park Care Ctr.*, DAB No. 1931 at 27-28 (2004)), *aff’d*, *Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006).

CMS asserts that Petitioner’s noncompliance with Medicare participation requirements represented a pattern of immediate jeopardy to resident health and safety (scope and severity level “K”) from January 13, 2017 through January 23, 2017.  CMS Posthrg. Br. at 12-13.  Petitioner argues that the finding of immediate jeopardy was clearly erroneous.  P. Posthrg Br. at 22.  Petitioner’s main argument is that there can be no finding of

**Page 19**

immediate jeopardy because it substantially complied with Medicare participation requirements.  *Id.*I agree with Petitioner’s argument, but only in part.  As I explain below, Petitioner’s duty to implement its Gastroenteritis Policy and other related infection control policies could only arise once it became apparent that the facility was experiencing an outbreak of viral gastroenteritis.

As I have described above, Petitioner’s expert witnesses all agreed that it is not possible to identify an outbreak of viral gastroenteritis on the first day patients get sick.  *See, e.g.*, Tr. at 189-90, 304, 351-52; *see also*P. Ex. 59 at 7 (¶ 8); P. Ex. 61 at ¶ 7.  CMS presented no evidence to the contrary.  I therefore find that CMS clearly erred in determining that a situation of immediate jeopardy existed at Petitioner’s facility as of January 13, 2017.  On the other hand, the medical professionals who expressed an opinion agreed that, by January 16, 2017, there was sufficient information to conclude that Petitioner was experiencing an outbreak.  Tr. at 141, 148-49, 236, 341.  I therefore find that, as of January 16, 2017, Petitioner had a duty to implement its policies and procedures for responding to an outbreak of viral gastroenteritis.  However, as I have already explained in the preceding sections of this decision, Petitioner did not fully and adequately implement its policies and procedures.  On and after January 16, 2017, it was not clearly erroneous to conclude that Petitioner’s residents were likely to experience serious injury, harm, impairment, or death as a result of Petitioner’s noncompliance.

Ms. Campbell, the former CDPH public health nurse, testified that gastroenteritis can be serious for the elderly and those with comorbidities because, for example, repeated vomiting and diarrhea can lead to dehydration, which may require therapy with intravenous fluids.  CMS Ex. 44 at ¶ 5.  In severe cases, patients with gastroenteritis may require hospitalization or even lead to death.  *Id.* Drs. Lopman and Robinson confirmed the serious risks that an outbreak poses in a long‐term care facility.  P. Ex. 59 at 3 (¶ 5) (for institutionalized elderly, gastroenteritis “may progress to more severe or prolonged illness and, occasionally, death”); P. Ex. 63 at ¶ 10 (norovirus outbreak may “wreak havoc within a facility”).  In fact, several of Petitioner’s affected residents did require hospitalization, and two later died.16
  CMS Ex. 24.  Petitioner’s evidence that the outbreak at its facility was of relatively short duration, in statistical terms (*see*Tr. at 316), does not demonstrate that the finding of immediate jeopardy was clearly erroneous because, during the outbreak, all Petitioner’s residents were at risk of contracting norovirus.

**Page 20**

***5.   A CMP of $10,841 per day from January 16, 2017, through January 23, 2017, is reasonable in amount and duration.***

I have concluded that Petitioner failed to comply substantially with 42 C.F.R. §§ 483.80(a)(1) and 483.70.  In addition, I have found that CMS did not clearly err in determining that Petitioner’s noncompliance posed immediate jeopardy to Petitioner’s residents from January 16, 2017 through January 23, 2017.

To determine whether a CMP is reasonable, I examine the factors listed in 42 C.F.R. § 488.438(f):  1) the facility’s history of noncompliance; 2) the facility’s financial condition; 3) the factors specified in 42 C.F.R. § 488.404; and 4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety.  The absence of culpability is not a mitigating factor.  42 C.F.R. § 488.438(f).  The factors listed in § 488.404 include:  1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.  Unless a facility contends that a particular regulatory factor does not support the CMP amount that CMS imposed, the administrative law judge must sustain it.  *Coquina Ctr.*, DAB No. 1860 at 32 (2002).

The regulations specify that a per day CMP will fall into one of two ranges of penalties.  42 C.F.R. §§ 488.408, 488.438.  CMS imposes a CMP in the upper range, $6,291 to $20,628 per day, 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).17
  CMS imposes a CMP in the lower range, $103 to $6,188 per day, 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).  In assessing the reasonableness of a CMP amount, an administrative law judge considers the per day amount, rather than the total accrued CMP.  *See Kenton Healthcare, LLC*, DAB No. 2186 at 28 (2008).  The regulations leave the decision regarding the choice of remedy to CMS, and the amount of the remedy to CMS and the administrative law judge, requiring only that the regulatory factors at §§ 488.438(f) and 488.404 be considered when determining the amount of a CMP within a particular range.  42 C.F.R. §§ 488.408, 488.408(g)(2); 498.3(d)(11); *see also*42 C.F.R. § 488.438(e)(2) and (3); *Alexandria Place*, DAB No. 2245 at 27 (2009); *Kenton Healthcare*, DAB No. 2186 at 28-29.

**Page 21**

Petitioner argues that the CMP amount is unreasonable because there is no basis to impose a CMP at all.  P. Posthrg. Br. at 23.  I have explained above why I conclude CMS had a basis to impose a CMP.  Having considered the regulatory factors, I conclude that the CMP imposed in this case is reasonable for the period January 16, 2017, through January 23, 2017.  The CMP imposed, $10,841, isfn valueor17 iThe CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102.  The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case (i.e., February 1, 2017).  *See*81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016).mefniate jeopardy CMPs.  Petitioner’s noncompliance was serious.  Its failure to follow carefully and completely its own policies for dealing with an outbreak of viral gastroenteritis placed all its residents at risk of exposure to norovirus, which is highly contagious.  As I have noted above, viral gastroenteritis can have extremely serious consequences for the health of elderly nursing home residents.  I therefore find the amount of the CMP reasonable.

V.      Conclusion

For the reasons stated in this decision, I sustain CMS’s determinations, in part.  I conclude that Petitioner was not in substantial compliance with the participation requirements at 42 C.F.R. §§ 483.80(a)(1) and 483.70 from January 16, 2017, through January 23, 2017.  I further find reasonable the $10,841 per day CMP imposed for Petitioner’s noncompliance.




          /s/
        Leslie A. Weyn

                      Administrative Law Judge
      1. I apply the regulations in effect at the time of the survey.  See Carmel Convalescent Hosp., DAB No. 1584 at 2 n.2 (1996) (applying regulations in effect on the date of the survey and resurvey). back to note 1
                      2. CMS also imposed a per day CMP of $303 for 15 days (from January 24, 2017, through February 7, 2017).  However, I dismissed as untimely Petitioner’s hearing request challenging that remedy.  See ALJ Ruling No. 2017-22 (July 14, 2017) (Docket No. C-17-700).  Petitioner did not request further review of the dismissal; it is therefore administratively binding.  42 C.F.R. § 498.71(b). back to note 2
                      3. Effective November 28, 2017, CMS adopted new interpretive guidance in Appendix PP to the State Operations Manual (SOM) revising the F-Tag numbers applicable to the various regulatory participation requirements.  See SOM Appendix PP (Rev. 173, issued 11/22/2017).  However, CMS and state agencies were still using the prior F-Tag designations at the time of the survey at issue in the present case. back to note 3
                      4. CMS and state survey agencies consider the scope and severity of deficiencies when selecting enforcement remedies.  CMS summarizes the scope and severity levels in a matrix published in the SOM.  SOM, CMS Pub. 100-07, ch. 7, § 7400.5.1 (Rev. 63, eff. Sept. 10, 2010, was in effect at the time of the survey at issue) (in the current version of the SOM (Rev. 185, eff. Nov. 16, 2018), the scope and severity matrix appears at § 7400.3.1).  “Scope” describes how many residents are potentially affected by a particular deficiency.  Deficiencies may be “isolated,” “pattern,” or “widespread” in scope.  “Severity” describes the possible harm that a deficiency may cause.  A scope and severity level of A, B, or C describes a deficiency that causes no actual harm with the potential for minimal harm.  Facilities cited with deficiencies at level C or lower remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F describes a deficiency that has caused no actual harm with the potential for more than minimal harm that is not immediate jeopardy.  A scope and severity level of G, H, or I describes a deficiency that has caused actual harm that is not immediate jeopardy.  Scope and severity levels J, K, and L describe deficiencies that pose immediate jeopardy to resident health or safety. back to note 4
                      5. CMS increases the CMP amounts annually to account for inflation in compliance with the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015, 104 Pub. L. No. 114-74, § 701, 129 Stat. 584, 599 (2015).  See 81 Fed. Reg. 61,538 (Sept. 6, 2016). back to note 5
                      6. Joy Shepherd, one of the state agency surveyors, testified that Petitioner’s administrator reported that the facility did not have an infection control policy.  CMS Ex. 45 at ¶ 8.  Petitioner’s administrator, Ms. Hardy, denied that any surveyor asked her for the facility’s infection control policy.  See, e.g., Tr. at 407-08.  Petitioner’s DON, Ms. Buckles, also testified that none of the surveyors asked for the facility’s infection control policy.  Id. at 247.  Both Ms. Hardy and Ms. Buckles thought it was odd that no one asked for the infection control policy because, in their experience, it was routine for surveyors to do so.  Id. at 247, 407.  Finally, Ms. Shepherd acknowledged that she did not ask to see the entirety of Petitioner’s infection control policy.  Tr. at 69.  In addition, I find credible Ms. Buckles’ testimony that she offered a copy of Petitioner’s Gastroenteritis Policy (P. Ex. 1) to “Beth,” one of the surveyors.  See id. at 248.  I take notice that one of the survey team members was named Elizabeth Mayo.  See CMS Ex. 27 at 1. back to note 6
                      7. Petitioner’s policy of isolating residents for 48 hours was consistent with CDC recommendations.  CMS Ex. 22 at 12 (“place residents with norovirus gastroenteritis on Contact Precautions for a minimum of 48 hours after the resolution of symptoms”). back to note 7
                      8. The CDPH “Recommendations for Controlling an Outbreak of Viral Gastroenteritis in a Long Term Care Facility” states that facilities should call an epidemiologist immediately if two or more residents “begin experiencing vomiting and/or diarrhea within a three‐day period.”  CMS Ex. 21 at 5.  This recommendation could be read as suggesting that an outbreak of gastroenteritis occurs as soon as two residents experience diarrhea.  As the testimony of Drs. Robinson and Tims-Cook makes clear, such a measure would be unworkable in a long-term care facility, where multiple residents may experience diarrhea on any given day for reasons totally unrelated to viral illness.  In any event, CMS has nowhere argued that this is the standard for defining a viral outbreak. back to note 8
                      9. Although Petitioner’s Gastroenteritis Policy required residents to be isolated for 48 hours after their symptoms subsided, Dr. Markle’s orders stated that patients were to be kept in their rooms for only 24 hours.  Compare P. Ex. 1 at 2 with CMS Ex. 29 at 7. back to note 9
                      10. A flyer published by the Georgia Department of Public Health suggests that the electronic State Electronic Notifiable Disease Surveillance System is to be used when a report is required within seven days (i.e. not for immediate reporting).  See CMS Ex. 25.  However, the flyer does confirm that the Department’s toll-free number may be used for immediate reporting.  Id. back to note 10
                      11. Petitioner’s expert witnesses, Dr. Robinson and Dr. Tims-Cook, apparently also believed that reporting the outbreak was not possible on a holiday.  See P. Ex. 63 ¶ 17; P. Ex. 61 at ¶¶ 4, 11, 17.  However, I accord their opinions on this point little weight because Petitioner did not establish a foundation for the witnesses’ opinions.  For example, Dr. Robinson, who is retired, previously practiced in Florida.  P. Ex. 63 at ¶ 1.  Thus, it is unlikely that he would be familiar with the mechanics for reporting an outbreak in Georgia.  Moreover, I infer Dr. Tims-Cook’s testimony (P. Ex. 61 at ¶ 17) likely refers to CDPH’s business hours.  I find credible Ms. Campbell’s testimony that the Georgia State Department of Health maintains a toll-free telephone number that allows 24-hour reporting, without regard to holidays or weekends. back to note 11
                      12. CDPH recommended that residents remain isolated for 72 hours after their symptoms subsided.  See, e.g., CMS Ex. 21 at 5. back to note 12
                      13. Petitioner’s Isolation Policy did not specify what was meant by “substantial contact.”  Nevertheless, a surveyor observed one of Petitioner’s CNAs preparing to bathe an affected resident, although the CNA was not wearing a gown.  CMS Ex. 5 at 16.  Bathing a resident would seem to require “substantial contact” under any reasonable definition of the term. back to note 13
                      14. I find that Petitioner complied substantially with subsection (a)(2) of 42 C.F.R. § 483.80 because it had an infection control policy that addressed the required components.  I do not address Petitioner’s compliance with subsections (a)(4), (e), or (f).  I am permitted, “in the interests of judicial economy, [to] review only those deficiencies that have a material impact on the outcome of the dispute.”  Claiborne-Hughes Health Center v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010). back to note 14
                      15. It is possible that the policy to use a gown “if substantial contact . . . is anticipated” may have contributed to staff’s uncertainty about when it was appropriate to use gowns.  But, if so, it would be incumbent on Petitioner’s administration to provide clear instructions on implementing the policy. back to note 15
                      16. The record before me does not establish that the residents who died succumbed to complications from gastroenteritis.  I therefore do not rely on the fact that a patient or patients may have died in reaching the conclusion that Petitioner’s noncompliance posed immediate jeopardy to its residents. back to note 16
                      17. The CMP ranges listed in the regulations are adjusted annually for inflation under 45 C.F.R part 102.  The amounts I cite here were those in effect at the time CMS imposed the remedies at issue in the present case (i.e., February 1, 2017).  See 81 Fed. Reg. 61,538, 61,549 (Sept. 6, 2016). back to note 17 Back to top
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