Shiloh First Health Care, Inc., DAB CR6467 (2024)

DECISION ON REMAND

I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose a $10,000 per-instance civil money penalty against Petitioner, Shiloh First Healthcare, Inc., a home health care agency. 

I. Background

This case originated when CMS determined to impose a civil money penalty against Petitioner after state surveyors found, in August and October 2016, that Petitioner failed to comply with a Medicare participation requirement.  Petitioner requested a hearing to challenge the noncompliance findings and the remedy determination.  

The case was assigned to another administrative law judge.  It was reassigned to me on February 5, 2018.  On March 20, 2018, I granted summary judgment in favor of CMS, finding that undisputed material facts established that Petitioner had failed to comply with Medicare participation requirements and that CMS’s remedy determination was reasonable.  

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Petitioner appealed my decision to the Departmental Appeals Board, and on October 24, 2019, a Board appellate panel remanded the case to me, finding that there were disputed issues of material fact that necessitated a hearing.  Shiloh First Health Care, Inc., DAB No. 2974 (2019).  On December 23, 2019, I again granted summary judgment in favor of CMS.  Petitioner appealed this second decision to the Board.  

The Board’s appellate panel then deliberated for four years.  On December 5, 2023, it issued a second remand decision.  The panel again found that there were disputed issues of material fact and it directed that I hear and decide the case “without further delay.”  Shiloh First Health Care, Inc., DAB No. 3123 (December 5, 2023). 

Acting in response to the remand, I received the parties’ exhibits into evidence.  These included CMS Ex. 1 – CMS Ex. 22 and P. Ex. 1.  CMS initially objected to P. Ex. 2, an unsworn affidavit executed by Ms. Bibian Mukoro, R.N., who is Petitioner’s owner and supervising nurse.  I afforded Petitioner a second opportunity to submit a sworn and/or notarized affidavit from Ms. Mukoro.  Petitioner offered a revised P. Ex. 2, which is a notarized affidavit executed by Ms. Mukoro.  CMS did not object to the revised P. Ex. 2, which I receive into evidence. 

CMS initially requested to cross-examine Ms. Mukoro.  It withdrew that request.  Petitioner did not request to cross-examine Vivienne Phillips, R.N., who is CMS’s sole witness.  CMS Ex. 22.  That neither party requested cross-examination means that no purpose would be served by an in-person hearing.  I therefore hear and decide this case based on the written record.¹  In doing so I weigh the evidence and make credibility findings as is appropriate. 

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II. Issues, Findings of Fact and Conclusions of Law

A. Issues

The issues are whether Petitioner failed to comply substantially with a condition governing a home health agency’s participation in Medicare and whether a per-instance civil money penalty of $10,000 is a reasonable remedy for Petitioner’s noncompliance. 

B. Findings of Fact and Conclusions of Law

1. Noncompliance

Home health agencies participate in the Medicare program subject to the requirements of regulations set forth at 42 C.F.R. Part 484.  These regulations include a condition set forth at 42 C.F.R. § 484.30.²  This condition directs a participating home health agency to furnish skilled nursing services to eligible Medicare beneficiaries under the supervision of a registered nurse and according to the beneficiaries’ plans of care.  The registered nurse must initiate appropriate preventative and rehabilitative nursing procedures. 

CMS alleges that Petitioner failed to comply with this condition.  It asserts that Petitioner’s registered nurse (Ms. Mukoro) violated the condition because she re-used a lancet for drawing blood in order to determine patients’ blood sugar levels, violating a professionally recognized standard of care requiring lancets to be used on only on one patient and not reused on other patients.³ 

A “lancet” is a fingerstick device that contains a needle that punctures the skin in order produce blood to measure blood sugar levels.  There are two types of devices:  those that are disposed of after a single use and those that are reusable but, only on a single individual.  A lancet should never be used on multiple individuals.  Both the Centers for Disease Control (CDC) and CMS have issued guidance directing that lancets never be used on more than one individual because of the possibility that they may transmit blood-borne disease if used in that manner.  CMS Ex. 18; CMS Ex. 19; CMS Ex. 21. 

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A lancet includes a metering device along with the penetrating needle.  When a lancet is used, the top of the metering device is placed directly against the patient’s skin.  Blood drawn from the patient transfers to the metering device.  There is a possibility that a quantity of the patient’s blood may become embedded in the small opening in the metering device from which the lancet’s needle protrudes.  CMS Ex. 22 at 2.  If the lancet is used on more than one individual there is a possibility that embedded blood may be transferred from one individual to the next.  If that blood contains a pathogen, it may transmit that pathogen to the second individual.  Wiping a lancet with alcohol in an effort to disinfect it between uses is not effective because it may not remove embedded blood.  Id. at 3. 

Ms. Phillips testified that she observed Ms. Mukuro using a lancet to check the blood sugar level of a patient.  CMS Ex. 22 at 2.  She saw Ms. Mukuro attempting to disinfect the lancet with a disinfecting wipe.  Id.  Ms. Phillips averred that Ms. Mukuro told her that she kept a glucometer for use on patients who needed blood sugar checks.  According to Ms. Phillips, Ms. Mukuro stated that she cleaned the lancet with a disinfecting wipe in between patients.  Id. at 3.  Ms. Phillips stated: 

I specifically asked . . . [Ms. Mukoro] whether she took any additional measures to disinfect the lancing device.  She informed me that that she believed that wiping the lancing device on the outside with a disinfecting wipe was sufficient.  I also asked her whether this was the standard procedure she typically employed when using the lancing device and whether this was the device she normally used.  She informed me that these were the steps and device she typically used when checking glucose levels at Shiloh. 

Id. 

Ms. Phillips interviewed two of Petitioner’s patients, Patient # 2 and Patient # 4.  She avers that both patients told her that Ms. Mukoro checked their blood sugar levels with the equipment that she brought with her on visits to these patients.  P. Ex. 22 at 3. 

Ms. Phillips’ testimony is evidence, if not rebutted by Petitioner, that establishes that Ms. Mukoro improperly re-used a lancet on more than one patient to check blood sugar levels.  It establishes also that Ms. Mukoro used a disinfecting technique that was ineffective in protecting patients from exposure to other patients’ blood, thereby creating a pathway for the transmission of blood-borne pathogens. 

Petitioner’s sole evidence is Ms. Mukoro’s affidavit.  P. Ex. 2.  I find that it does not rebut or discredit Ms. Phillips’ testimony. 

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In its brief, Petitioner asserts that none of its nurses “at any time, use the same lancing device on multiple patients.”  Petitioner’s pre-hearing brief at 1.  However, after denying that its nurses ever reuse lancets, Petitioner concedes that its nurses do just that: 

Shiloh’s supervising Nurse does not deny using the instruments, including lancing devise [sic], that she carries with her on field trips on patient[s] who do not have one, or run out of supplies to make theirs unusable, but emphatically denies that the only cleaning she does is wiping it with disinfecting wipe, as alleged. 

Id. at 6.

In her affidavit Ms. Mukoro avers that she “adopt[s] the contents of my Pre-hearing brief submitted by my Attorney in my defenses . . . .”  P. Ex. 2 at 1.  I accept that statement as a general denial of Ms. Phillips’ findings.  Her general denial aside, Ms. Mukoro does not explicitly deny any of Ms. Phillips’ findings.  She does not deny reusing a lancet on more than one patient.  She does not explicitly deny attempting to disinfect the device between uses by wiping it with a disinfectant.  See P. Ex. 2 at 1-2. 

Ms. Mukoro does not assert that professionally recognized standards of care allow her to use a lancet on more than one patient.  Nor does she deny that the CDC and CMS advise against using a lancet on more than one patient.  She offers no evidence to show that her attempts at disinfecting a lancet between uses effectively prevented the transmission of blood (and possibly blood-borne pathogens) from one patient to another.  See P. Ex. 2 at 1-2. 

I find not credible Ms. Mukoro’s general denial and failure to explicitly rebut Ms. Phillips’ findings.  Ms. Mukoro and Petitioner had the opportunity to explain exactly how Ms. Mukuro tested the blood sugar levels of Petitioner’s patients.  If she did not re-use a lancet, she might have offered an affirmative evidence showing that, in fact, she used a separate lancet on each patient.  She might have offered proof showing that she discarded each lancet after she used it, and how she did so.  But she offered none of that.  Most significantly, Ms. Mukoro does not explain how she cleans the lancet that she re-uses.  Denying that she wipes it with a disinfectant hardly explains how she ensures that blood is not transmitted from one patient to the next when the lancet is re-used.  See P. Ex. 2. 

The gravamen of Ms. Mukoro’s affidavit is her complaint that Ms. Phillips was antagonistic and biased.  Rather than addressing CMS’s allegations head on, Ms. Mukoro testifies that Ms. Phillips – and by extension, CMS – is biased against her, for unknown reasons.  P. Ex. 2 at 1-2.  She asserts that Ms. Phillips used:  “whatever responses she got from . . . [Petitioner’s] patients . . . to draw out-of-context and negative conclusions about . . . [Petitioner’s] practices without giving . . . [Petitioner] the opportunity to relate it to the context.”  Id. at 1.  Ms. Mukoro contends that Ms. Phillips: “exaggerated and

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construed every finding to result in the worst punitive outcome for . . . [Petitioner].”  Id. at 2. 

But none of these claims of bias rebut Ms. Phillips’ findings.  Even if Ms. Phillips was antagonistic towards Petitioner, her antagonism – if it existed at all – did not undercut the very specific findings that she made.  And as I have stated, Ms. Mukoro, who had the opportunity to do so, did not deny Ms. Phillips’ findings explicitly. 

2. Remedy

CMS determined that Petitioner’s noncompliance with the requirements of 42 C.F.R. § 484.30 was so egregious as to comprise immediate jeopardy for beneficiaries serviced by Petitioner.  However, and as CMS acknowledges, a finding of immediate jeopardy level noncompliance is not a necessary element of this case or of my decision. 

I do not find that Petitioner’s noncompliance caused Medicare beneficiaries to be in immediate jeopardy.  Rather, I review the civil money penalty of $10,000 based on the regulatory criteria governing penalty amounts where home health agencies are found not to be in substantial compliance with conditions governing their participation in Medicare. 

Regulations authorize imposition of civil money penalties against home health agencies as remedies for their failure to comply with Medicare participation requirements.  42 C.F.R. § 488.845.  A civil money penalty may be imposed either for each day of a home health agency’s noncompliance or for each instance of noncompliance.  Id.  Civil money penalties may be imposed against a home health agency:  “regardless of whether the [home health agency’s] deficiencies pose immediate jeopardy.”  42 C.F.R. § 488.845(a)(1).  That range applies whether or not immediate jeopardy is present. 

Petitioner’s noncompliance was very serious.  A penalty of $10,000 is reasonable because of the potentially dangerous consequences of that noncompliance.  Reuse of a lancet violates accepted standards of nursing practice.  Reuse is dangerous to patients because of the potential for transmitting blood-borne pathogens from one patient to another.  That danger persists even if one attempts to disinfect a lancet between uses by wiping it with a disinfectant.  The construction of the lancet renders it impossible to remove tiny blood particles with a disinfectant wipe.  Reuse is specifically prohibited by CDC guidelines.  CMS Ex. 21. 

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Petitioner asserts that CMS’s remedy choice is arbitrary.  I disagree.  The remedy is well grounded on the seriousness of Petitioner’s noncompliance and the danger that it posed for beneficiaries. 

Endnotes

¹  I issued rulings and an order on December 14, 2023 in which I noted that Petitioner had not requested to cross-examine Ms. Phillips.  Due to a clerical error unknown to me at the time, the Civil Remedies Division staff had failed to activate Petitioner’s participation in the Departmental Appeals Board’s e-filing system.  Consequently, Petitioner did not receive immediately the December 14 rulings and order.  However, the staff subsequently discovered the error and activated Petitioner’s participation.  Petitioner then received the rulings and order.  That is established by Petitioner’s filing of a notarized version of Ms. Mukoro’s affidavit, an action that I had addressed in the December 14 rulings and order.  Petitioner did not demand cross-examination of Ms. Phillips even after having received the December 14, 2023, rulings and order. 

²  The provision governing skilled nursing services at 42 C.F.R. § 484.30 was consolidated with provisions governing therapy and medical social services under 42 C.F.R. § 484.75, which governs skilled professional services.  82 Fed. Reg. 4504, 4514, 4566, 4574-75 (Jan. 13, 2017), as amended at 85 Fed. Reg. 27,628 (May 8, 2020). 

³  CMS initially alleged that Petitioner violated other home health agency conditions of participation in addition to the one that I address in this decision.  However, CMS has not offered argument concerning these other alleged violations.