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                              Oak Park, DAB CR5451 (2019)
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Oak Park, DAB CR5451 (2019)








  
  
    

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





Oak Park,
	(CCN: 01-5452),
	Petitioner,
v.
Centers for Medicare & Medicaid Services,
Respondent.
Docket No. C-18-1337Decision No. CR5451October 23, 2019

        
              
    

      DECISION
I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose remedies against Petitioner, a skilled nursing facility, consisting of civil money penalties of $8,749 for each day of a period that began on May 23, 2018, and that ran through May 28, 2018.1
I. Background
I held a hearing on June 27, 2019, for the purpose of cross-examination and re-direct testimony of witnesses.  I received into evidence exhibits offered from CMS that it identified as CMS Ex. 1-CMS Ex. 33 and exhibits from Petitioner that it identified as P. Ex. 1-P. Ex. 7 and P. Ex. 14-P. Ex. 15.  I sustained objections offered by CMS to P. Ex. 8-P. Ex. 13 and excluded those exhibits from evidence.  March 26, 2019 Summary of Pre-Hearing Conference and Notice of Hearing.
Page 2
II.  Issues, Findings of Fact and Conclusions of Law
**A.  Issues**
The issues are whether CMS’s determination of immediate jeopardy level noncompliance is clearly erroneous and whether CMS’s remedy determination is reasonable.
**B.  Findings of Fact and Conclusions of Law**
Petitioner’s noncompliance with Medicare participation requirements is not at issue.  It concedes that it failed to comply substantially with requirements set forth at 42 C.F.R. §§ 483.35(a)(3)-(4) and 483.80(a)(1)-(2), (a)(4), (e), and (f).  These regulations require a skilled nursing facility to employ a nursing staff that possesses the competency and skill level necessary to provide services that meet residents’ needs in a manner that promotes the residents’ safety and physical, mental, and psychosocial well-being.  They require also that a skilled nursing facility develop and implement a written infection prevention and control program to prevent, identify, and control the onset and spread of infection to the extent possible.
Undisputed facts establish Petitioner’s noncompliance and its systemic nature.  Petitioner’s noncompliance persisted for years.
Petitioner’s nursing staff regularly checked the blood sugar levels of residents suffering from diabetes with devices known as “glucometers.”  The Centers for Disease Control and Prevention (CDC) recommends that these devices not be used on more than one patient due to the potential for disease transmission that arises from shared usage of glucometers.  Shared usage creates an opportunity for exposure to blood-borne viruses, including Hepatitis B, Hepatitis C, and HIV.  CMS Ex. 19 at 2.  However, if glucometers are shared, they must be both cleaned and disinfected after each use per manufacturer’s instructions.  *Id.* at 4.
Petitioner used glucometers on multiple residents, and it was thus mandatory that its staff clean and disinfect those devices after each use.
“Cleaning” and “disinfecting” are terms of art with distinct meanings.  “Cleaning” is the act of removing organic and inorganic contaminants from the surface of devices.  CMS Ex. 30 at 2.  “Disinfecting” consists of killing any bacterial or viral organisms that may remain on glucometers after they have been cleaned.  *Id.*Cleaning may be accomplished by using solvents such as alcohol.  Cleaning doesn’t assure disinfection.  The manufacturer of the devices used by Petitioner recommends that, if they are used on more than one individual, they be cleaned by wiping them with Super Sani-Cloths, an Environmental Protection Agency-approved disinfectant.  CMS Ex. 23 at 45-46.
Page 3
Petitioner’s staff failed to follow these recommendations.  It cleaned glucometers after each use by wiping them with 70 percent isopropyl alcohol prep pads.  It failed to take additional measures to disinfect the glucometers.  That, notwithstanding the fact that, in 2008, the CDC issued guidance stating that isopropyl alcohol is an ineffective disinfectant against certain bacteria and viruses.  CMS Ex. 31 at 39.  The staff did not follow the manufacturer’s recommendation that Super Sani-Cloths be used to disinfect the glucometers.
Petitioner’s staff misunderstood the difference between cleaning and disinfecting glucometers.  One of Petitioner’s nurses, when interviewed, stated that the staff used a 70 percent isopropyl alcohol pad, both to clean and to disinfect glucometers.  CMS Ex. 2 at 23.  She had advised Petitioner’s staff to follow that protocol for three-and-a-half years.  *Id.*She wrongly believed that isopropyl alcohol was an effective means of destroying blood-borne pathogens.  *Id.*; *see* CMS Ex. 31 at 39.  Other members of Petitioner’s staff also failed to understand the difference between cleaning and disinfecting glucometers.  *E.g.*, CMS Ex. 2 at 27.
CMS determined that Petitioner’s noncompliance was so egregious as to pose immediate jeopardy for Petitioner’s residents.  The civil money penalties that CMS determined to impose and that are at issue here are reserved for immediate jeopardy level noncompliance.  Petitioner challenges the finding of immediate jeopardy and the resulting remedies.
“Immediate jeopardy” is defined at 42 C.F.R. § 488.301 to mean noncompliance that is so egregious as to create a likelihood of serious injury, harm, impairment or death for a resident or residents of a skilled nursing facility.  A skilled nursing facility that is the recipient of an immediate jeopardy noncompliance determination may challenge that finding and its duration.  In doing so, it bears the burden of proving that the finding is clearly erroneous.  42 C.F.R. § 498.60(c)(2); *Universal Health Care – King*, DAB No. 2383 at 16 (2011), *aff’d*, *Universal Healthcare/King v. Sebelius*, 400 F. App’x 299 (4th Cir. 2012).
A finding of immediate jeopardy need not be predicated on a finding of actual harm to a resident.  A likelihood of serious harm, injury, impairment, or death is the minimum necessary criterion for an immediate jeopardy finding.  *Life Care Ctr. of Tullahoma*, DAB No. 2304 at 58 (2010), *aff’d sub nom. 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).  Thus, CMS may predicate a finding of immediate jeopardy on noncompliance that consists of systemic failure by a facility staff to comply with participation requirements that likely will lead to serious harm in the future to residents of a skilled nursing facility even if none of the residents suffers immediate harm from the deficient conduct.
Page 4
The clearly erroneous standard imposes a heavy burden on the facility that challenges an immediate jeopardy level noncompliance finding.  A challenging facility must prove that harm or threatened harm does not meet any reasonable definition of “serious.”  *Daughters of Miriam Ctr.,*DAB No. 2067 at 9 (2007).  If the challenging facility does not offer evidence that excludes every reasonable ground that supports a finding of immediate jeopardy then the finding of immediate jeopardy must be sustained.
CMS predicates its immediate jeopardy finding not just on Petitioner’s acknowledged noncompliance but on findings made by experts that illuminate the dangers posed by the failure to disinfect shared glucometers.  The risk, as described by the CDC, is that an improperly disinfected glucometer may come into contact with a resident’s fingerstick wound.  In that event, the glucometer itself may serve as a vehicle for transmitting pathogens to the patient:
Indirect contact transmission can also occur even if the patient never directly contacts the meter.  Healthcare personnel hands can become contaminated with blood at various points while performing assisted blood glucose monitoring including pricking the patient’s finger or handling the patient’s test strip.  Blood can then be transferred to the meter when healthcare personnel handle the meter to obtain the reading.  If the meter is not cleaned and disinfected after use, the blood remaining on the meter can be transferred to subsequent patients via healthcare personnel hands when they handle the meter and then assist with fingerstick procedures.  *Numerous outbreaks have implicated this mechanism in the spread of [Hepatitis B] infections.*
CMS Ex. 19 at 11 (emphasis added).  The CDC noted that the Hepatitis B virus has been found to remain infectious in dried blood on environmental surfaces for at least seven days.  *Id.*
The dangers posed by un-disinfected glucometers, as described by the CDC, are more than a reasonable basis for CMS’s determination of immediate jeopardy level noncompliance.  The risk to residents of disease transmission from glucometers that have not been disinfected properly is not hypothetical.  It is real and has been verified in numerous instances.
I do not find that the arguments and evidence offered by Petitioner establish CMS’s determination to be unreasonable and therefore clearly erroneous.  Petitioner argues that it implemented safeguards at its facility that assured that none of its residents were infected with blood-borne pathogens.  It reasons that if none of its residents were infected the chances of spread of infection from resident to resident were nil.  As support for this argument, Petitioner asserts that it screened all of its residents upon admission for blood-
Page 5
borne pathogens including Hepatitis B and HIV.  It argues that its screening process assured that no residents were infected.
Petitioner did not define what it meant by this screening process.  Did its staff review resident applicants’ medical records for a history of viral infections?  Did it perform blood tests on applicants to determine that they were not infected?  Petitioner doesn’t say.  It did not offer evidence addressing its individual residents’ medical histories nor did it produce proof, consisting of laboratory results, that its residents were infection-free.
If Petitioner examined residents’ medical records for infection, the obvious problem is the possibility that the records might not reveal infections that exist.  I take notice that Hepatitis B and HIV are not necessarily symptomatic in their early stages.  A resident could easily be infected and in an asymptomatic stage of the disease, and that infection would not be reported because no one thought to test for it.  Another obvious problem is that residents might become infected while residing at Petitioner’s facility.  A resident could acquire a blood-borne pathogen during a hospital stay.  The resident could return to the facility with an undetected infection.  Petitioner’s screening process would not reveal that.  Residents might also become infected while at Petitioner’s facility from contact with infected third parties.
In short, Petitioner’s screening process – however Petitioner conducted it – does not exclude the risk of an infected individual becoming a resident of the facility or of a resident acquiring an infection while at the facility.
Petitioner also argues that, while it reused its glucometers on multiple residents, the lancets that were used to perform fingersticks were discarded after every use.  It contends that the glucometers never came into contact with the residents’ skin.  Thus, according to Petitioner, this practice of discarding lancets after each fingerstick provided its residents with absolute protection against coming into contact with pathogens.
The CDC’s findings refute this argument.  As the CDC points out, a health care worker could come into contact with a blood-borne pathogen on the surface of a glucometer and then transmit that pathogen, either to the lancet or directly to a patient’s fingerstick wound.  CMS Ex. 19 at 11.
Petitioner argues that CMS failed to follow its survey protocol in making its immediate jeopardy noncompliance findings and that it delayed unreasonably in transmitting its findings of immediate jeopardy to Petitioner.  These arguments are attacks on the process by which CMS came to its determination.  How CMS came to its finding of immediate jeopardy level noncompliance is irrelevant.  As I have explained, the undisputed facts establish Petitioner’s noncompliance with participation requirements.  Given that, Petitioner faces the heavy burden of proving that CMS’s immediate jeopardy determination is clearly erroneous.  It doesn’t matter how CMS obtained the evidence
Page 6
that led it to make its determination.  All that matters at this juncture is whether Petitioner can prove it to be clearly erroneous.
Petitioner also argues that it was denied due process because it was not able to cross-examine Ms. Jorie Scott, one of the surveyors who made findings leading to CMS’s immediate jeopardy level noncompliance determination.  Petitioner characterizes Ms. Scott’s findings as instrumental and it asserts that its inability to cross-examine this surveyor crippled its defense.
I find this assertion to be without merit.  Although CMS did not provide Ms. Scott’s direct testimony, Petitioner could nevertheless have requested that I subpoena her if it believed that examining her under oath was critical.  It did not.
Furthermore, and as I have explained, the findings of noncompliance – conceded by Petitioner – emanate from undisputed facts.  Petitioner has made no showing that Ms. Scott, had she testified, would have altered those facts in the least.  Finally, and as I explained on the record of the hearing, I do not accept surveyors’ conclusions as to matters of law.  A conclusion by any witness – whether that witness is a surveyor or someone else – that Petitioner’s noncompliance constituted immediate jeopardy is a legal conclusion that I do not accept as evidence.
The penalty amount that CMS imposed, $8,749 per day, is modest when measured against the severity of Petitioner’s noncompliance and Petitioner’s poor compliance history.  It amounts to only about 40 percent of the allowable maximum daily penalty.  The evidence, measured against applicable regulatory factors, establishes this penalty amount to be eminently reasonable.
The seriousness of Petitioner’s noncompliance is amply supported by the CDC’s explanation of the risks to patients, and skilled nursing facility residents, of using shared un-disinfected glucometers.  42 C.F.R. § 488.438(f)(3) (incorporating by reference 42 C.F.R. § 488.404).  It is unnecessary for me to restate those risks here.  The seriousness of Petitioner’s noncompliance is amplified in this case by the fact that Petitioner’s staff was operating in plain ignorance of the CDC’s conclusions and of the recommendations of the manufacturer of the glucometer devices used in Petitioner’s facility.  A competent staff would have known about these conclusions and recommendations.  Petitioner’s staff’s ignorance is stark evidence of incompetence.
Indeed, the need to disinfect and not just clean the glucometers was a fundamental tenet of nursing that the staff ignored.  CMS Ex. 30 at 2.  The staff also ignored or failed to obtain explicit instructions about disinfection from the glucometers’ manufacturer.  CMS
Page 7
Ex. 23 at 45-46.2
  In sum, the record of this case paints a picture of a staff that was woefully unprepared to perform the basic function of safely checking the blood sugar levels of Petitioner’s residents.
Petitioner’s compliance history also is a basis for establishing the civil money penalty amount.  42 C.F.R. § 488.438(f)(1).  Over the years Petitioner has been repeatedly cited for noncompliance with multiple participation requirements.  These include deficiencies that caused actual harm to residents.  CMS Ex. 27.
Finally, I sustain the duration of the daily immediate jeopardy level penalties, consisting of a period running from May 23 through May 28, 2018.  CMS ended these penalties on the date that it determined that Petitioner alleviated its immediate jeopardy level noncompliance.  Petitioner did not offer evidence proving that it had removed immediate jeopardy at an earlier date.


          /s/
        Steven T. Kessel

                      Administrative Law Judge
      1. Petitioner did not challenge additional civil money penalties of $505 per day. back to note 1
                      2. When asked to produce the manual for cleaning and disinfecting glucometers, Petitioner’s staff produced an outdated Australian manual that advised about maintenance of glucometers that were used only by a single individual and not shared. CMS Ex. 24. back to note 2 Back to top
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