Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Shiloh Nursing and Rehab, LLC,
Centers for Medicare & Medicaid Services.
Docket No. C-21-284
Decision No. CR5940
I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a per-instance civil money penalty of $5,000 against Petitioner, Shiloh Nursing and Rehab, LLC, a skilled nursing facility.
The parties filed pre-hearing exchanges that included briefs and proposed exhibits, identified as CMS Ex. 1-CMS Ex. 12 and P. Ex. 1-P. Ex. 13. CMS filed the declarations of two witnesses – Lori Scroggins, R.N. and Daniel J. McElroy, R.N. – as CMS Ex. 9 and CMS Ex. 10. Petitioner filed the declarations of three witnesses – Mark L. Stillwell, M.D., F.A.C.P., Amber Brumley, R.N., and Lesly Rodriguez – as P. Ex. 6, P. Ex. 8, and P. Ex. 9. The parties filed requests for cross-examination of witnesses but subsequently withdrew those requests.
There would be no purpose in convening an in-person hearing inasmuch as neither party now requests to cross-examine witnesses. I decide this case based on the parties’ written exchanges, including the testimony of their witnesses. Neither party filed objections to my receiving exhibits into evidence. Consequently, I receive all of the parties’ exhibits.
The issues are whether Petitioner failed to comply substantially with a regulation that governs its participation in Medicare and, if so, whether a per-instance civil money penalty of $5,000 is a reasonable penalty amount.
II. Findings of Fact and Conclusions of Law
The regulation that is at issue here, 42 C.F.R. § 483.80, requires a skilled nursing facility to 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 communicable diseases and infections. Mere development of a program and promulgation of policies by a facility does not establish compliance. The regulation requires that a facility implement whatever program it develops. Golden Living Ctr. – Superior, DAB No. 2768 at 7, 20 (2017) (addressing the predecessor infection control regulation at 42 C.F.R. § 483.65). That means that a facility must enforce its policy in order to assure that its staff members comply with it.
The facts of this case are not complicated. Petitioner has an infection control program. Among other things, this program addresses measures and precautions that Petitioner’s staff must take in order to protect against the spread of COVID-19 (Covid). Covid is a highly contagious disease that can be spread easily by particles exhaled by an infected individual. P. Ex. 6 at 3. It is well known that individuals may be asymptomatic yet infected and capable of infecting others via the spread of exhaled particles. Id. at 4.
Petitioner’s infection control policy includes requirements governing its staff’s use of personal protective equipment, including face masks or respirators. The policy explicitly requires staff to assure that they wear masks that fit snugly over their noses and chins. CMS Ex. 8; CMS Ex. 9 at 3-4.
This policy is in accord with the recommendations made by the Centers for Disease Control and Prevention (CDC). Face masks should cover an individual’s nose and mouth in order to prevent the spread of infectious particles when the individual breathes, speaks, sneezes, or coughs. CMS Ex. 11 at 6. Proper fit of a face mask is a “critical factor” in preventing others from being exposed to infectious particles. Id. at 8.
However, on two occasions, surveyors visiting Petitioner’s facility observed members of the staff not properly wearing face masks. On August 31, 2020, a surveyor observed a registered nurse exiting a resident’s room into a common hallway, after having delivered medication to that room. CMS Ex. 5 at 3; CMS Ex. 9 at 3. The nurse was masked, but her nose was exposed. Id. The surveyor asked the nurse how she was supposed to wear the mask, and the nurse responded by acknowledging that the mask should cover her nose but had slipped down. Id.
On the following day, September 1, 2020, a surveyor observed a nursing assistant wearing a face mask that did not cover her nose. CMS Ex. 5 at 3. The assistant, when queried, acknowledged that the mask should cover her nose. But, she said, the mask was sliding down. Id.
These two episodes are absolute proof that members of Petitioner’s staff were not following Petitioner’s policy, or CDC guidelines, about wearing masks. A mask that does not cover one’s nose is obviously ineffective protection against the spread of Covid particles because an uncovered nose is a pathway for the particles to spread into the air.
I find that these incidents establish a failure by Petitioner to implement its infection control policy. Put simply, Petitioner did not assure that its staff members complied with the policy that it established. In both incidents reported by surveyors, the staff member admitted that she knew what the policy required but admitted at the same time that she hadn’t followed it.
It is not a justification for failure to follow the policy to say that a mask “slipped.” Absent full compliance with mask wearing requirements, the mask becomes less effective and the wearer is capable of spreading highly infectious particles.
Petitioner argues that CMS is unreasonably imposing a requirement of strict liability as a measure of compliance with the infection control requirement. But in this case, strict compliance isn’t an arbitrarily harsh measurement of compliance, it is absolutely necessary. The well-known infectiousness of Covid makes strict compliance with mask wearing requirements essential, indeed, “critical.” CMS Ex. 11 at 8.
This case is distinguishable from the kinds of cases in which strict liability has been held to be an inappropriate standard for measuring a skilled nursing facility’s performance. For example, it is inappropriate to hold a skilled nursing facility strictly liable for every accident that occurs on its premises, because, theoretically, some accidents are unforeseeable. For that reason, nursing facilities are bound to the requirement that they protect residents against foreseeable accidents. Here, however, it is entirely foreseeable that failure to wear a face mask properly potentially exposes residents of a facility and other staff members to Covid particles. Thus, holding a facility strictly accountable for enforcing an infection control requirement, such as a requirement that staff wear masks, is in no way equivalent to a hypothetical strict liability requirement in an accident case.
Petitioner argues that no proof exists that the two noncompliant staff members were providing care to residents when they violated mask wearing requirements. The evidence contradicts that assertion. The registered nurse who was observed not wearing her mask properly was seen exiting a resident’s room during the course of passing medications, with her nose uncovered. That is strong evidence that the nurse may have exposed a
resident or residents to her exhalations. Additionally, I find it to be improbable that the nursing assistant observed with an improperly fitting mask was wandering Petitioner’s premises at random and not involved in resident care. But, even if she was not directly involved in resident care at the time she was observed by the surveyor, she was potentially spreading virus particles throughout the facility when she walked around with her nose uncovered.
In its defense, Petitioner argues that there is no proof that the incidents of noncompliance posed any risk of harm to residents. For that, it relies on the testimony of Dr. Stillwell. P. Ex. 6. Dr. Stillwell premises his opinion on his assumption that the staff members who violated Petitioner’s policy were not actually providing care to residents at the time nor standing within six feet of another, potentially susceptible individual. Id. at 5.
I have explained why the reasonable inference is that the staff members actually were involved in resident care. Moreover, I find that Dr. Stillwell and Petitioner miss an obvious point. Even if the staff members were not in sufficiently close proximity to other individuals at the precise instances that surveyors observed them to be wearing their masks improperly, the potential existed that their failure to comply with facility policy might eventually expose residents or other staff members to Covid particles. The evidence supports the inference that these staff members were generally nonchalant about mask wearing requirements. That is because they knew that they were wearing their masks improperly, but nevertheless wore them that way.
Dr. Stillwell suggests that slippage of masks is an inevitable consequence when masks are worn on a regular basis. P. Ex. 6 at 5-6. That may be, but that doesn’t excuse staff members from failing to fix the problem immediately when it occurs.
It is irrelevant whether there is evidence showing that the staff members who violated Petitioner’s policy actually transmitted Covid to other individuals. Noncompliance rests on the potential for harm caused by failure by Petitioner’s staff to comply with Petitioner’s infection control policies. Nonchalant mask wearing can eventually lead to transmission of disease. That is enough to establish noncompliance.
CMS alleges an additional failure by Petitioner to comply with its infection control policy that relates to improper decontamination measures employed by a member of Petitioner’s staff in caring for an incontinent resident.
Petitioner’s infection control policy states in part that Petitioner considers hand hygiene to be the primary means to prevent the spread of infection. CMS Ex. 7. Its policy requires all members of its staff to wash their hands with soap and water after contact with any resident with infectious diarrhea. The policy states explicitly that the use of gloves does not substitute for the hand-washing requirement. Id.
A surveyor observed a member of Petitioner’s staff violating Petitioner’s hand-washing policy while treating an incontinent resident. While wearing gloves, a nursing assistant touched some of the resident’s stool. The nursing assistant removed her gloves and changed into new gloves without first washing her hands. CMS Ex. 5 at 5. When interviewed by a surveyor about the incident, the nursing assistant admitted that she should have washed her hands before donning new gloves, but that she was nervous and forgot to do so. Id.; CMS Ex. 2 at 24.
The failure to wash hands between removing contaminated gloves and donning new gloves is an obvious violation of Petitioner’s infection control policy. The potential for harm from this violation is evident. In removing the contaminated gloves the nursing assistant potentially could touch them with her bare hands, thereby contaminating them. If she fails to wash her hands before donning new gloves, she potentially could touch the exterior of the new gloves with her now-contaminated hands, leaving potentially infectious material on the exterior of the gloves.
I find that that this incident constitutes noncompliance by Petitioner with its infection control policy. As Petitioner’s own policy states, hand hygiene is a primary method of infection control. Failure by staff – even on a single occasion – to comply with that policy opens an avenue for the spread of infection. It is thus critical that staff always comply with the policy. Moreover, the fact that a staff member forgets to comply with the policy leads easily to the inference that the staff member has not been drilled sufficiently on the policy’s importance. Forgetting the most critical step in hand hygiene supports the conclusion that the staff member doesn’t understand the importance of that step.
Petitioner relies on the testimony of all three of its witnesses to assert that there is no evidence that the nursing assistant actually contaminated herself or others with her soiled gloves prior to removing them. P. Ex. 6 at 7; P. Ex. 8 at 3; P. Ex. 9 at 4. Such evidence is not a necessary predicate to conclude that that the potential existed for contamination when the assistant failed to wash her hands.
I have considered the additional defenses and arguments made by Petitioner and I find them to be without merit. Petitioner asserts that its noncompliance consists of “minor infractions” that should not derogate from its overall efforts at infection control and, in particular, from its efforts to combat the occurrence and spread of Covid at its premises. Petitioner’s pre-hearing brief at 6, 15. I disagree that the noncompliance was minor. The failure by staff to understand and to comply rigorously with Petitioner’s infection control policy vitiated that policy because it opened an avenue for the spread of infection within Petitioner’s facility. The extreme contagiousness of Covid is undisputed. See P. Ex. 6 at 3. A facility must be extraordinarily rigorous in its infection control efforts in order to combat the entry and spread of this disease into its premises. For that reason, even
isolated errors by staff aren’t minor because they can potentially lead to a widespread infection of staff and residents.
Petitioner criticizes surveyors for failing to identify the names of the staff members who failed to comply with infection controls. According to Petitioner, it was unable to provide additional in-service training to these individuals as a consequence of the surveyors failing to identify them. Petitioner’s pre-hearing brief at 17-18.
The argument is a red herring. Whether or not the staff members who violated Petitioner’s policy are identified by name doesn’t derogate from the fact that they were observed violating that policy.
Petitioner repeatedly refers to the measures that it undertook to construct and implement an infection control policy and touts its efforts as proof that it complied with regulatory requirements. See, e.g., Petitioner’s pre-hearing brief at 19. However, CMS does not base its noncompliance allegations on assertions that Petitioner’s infection control policy was on its face inadequate. The allegations – and my findings – of noncompliance stem from Petitioner’s failure to implement its policy. The evidence of noncompliance stands as irrefutable proof that Petitioner did not implement its policy. As I have explained, especially given the contagiousness of Covid, even a few instances of failures potentially put Petitioner’s entire resident population and its staff at risk.
Petitioner also suggests that CMS relies on new or unanticipated interpretations of the infection control regulation as a legal basis for finding Petitioner noncompliant and it asserts that I should not give deference to CMS’s interpretations. Petitioner’s pre-hearing brief at 19-23. I find nothing novel or unusual about the manner in which CMS interpreted the regulation in this case. There is no controversy that the regulation requires that a facility must implement any infection control policy that it develops. This is a straightforward and factually quite simple case of a failure to implement explicit policies.
The remedy that CMS determined to impose for Petitioner’s noncompliance is a $5,000 per-instance civil money penalty. I find that to be a reasonable amount.
In deciding the reasonableness of a remedy amount, I consider factors that include: the seriousness of a facility’s noncompliance, its culpability, its compliance history, and its financial condition. 42 C.F.R. §§ 488.438(f)(1)-(4), 488.404 (incorporated by reference into 42 C.F.R. § 488.438(f)(3)). I also consider the permissible range of penalties. For a per-instance civil money penalty, the maximum allowable amount in October 2020, when the penalty was imposed, was just over $20,000. 42 C.F.R. § 488.438(a)(2); 45 C.F.R. § 102.3 (2020).
The penalty in this case is modest, being only about 25 percent of the allowable maximum per-instance civil money penalty amount. The seriousness of the noncompliance amply justifies this modest penalty amount. As I have discussed, the failures by Petitioner’s staff to comply with Petitioner’s infection control policy put residents of the facility and other staff members at risk of potentially catastrophic consequences. Even a small risk that a staff member might spread Covid particles and infect other persons on Petitioner’s premises could trigger a cascade of infection that would be devastating to the frail and impaired residents of the facility.
Furthermore, Petitioner’s compliance history supports the penalty. The infection control noncompliance that I sustain here is not Petitioner’s first failure to comply with regulatory requirements governing infection control. In June 2020, Petitioner also was cited for failure to comply with infection control requirements. CMS Ex. 10.
Petitioner has not offered evidence that it lacks the wherewithal to pay the penalty.
Steven T. Kessel Administrative Law Judge