Shiloh First Health Care, Inc., DAB CR5052 (2018)

DECISION

I grant summary judgment in favor of the Centers for Medicare & Medicaid Services (CMS), sustaining its decision to impose a $10,000 per-instance civil money penalty against Petitioner, Shiloh First Health Care, Inc., a home health care agency.

I. Background

This case was assigned originally to another Administrative Law Judge.  It was reassigned to me at the beginning of February of this year.  Pursuant to that judge’s pre-hearing order, CMS filed a brief and proposed exhibits that it identified as CMS Exhibit (Ex.) 1-CMS Ex. 22.  CMS also filed a motion for summary judgment.  Petitioner filed a brief in which it opposed CMS’s motion and an exhibit that it identified as P. Ex. 1.In its pre-hearing exchange, Petitioner asserted that it was filing a second exhibit that it identified as P. Ex. 2. Purportedly, this exhibit is an affidavit or declaration containing the testimony of a nurse, Bibian Mukoro. However, Petitioner did not file this purported exhibit. I noticed that the purported exhibit had not been filed when I reviewed the case record after it had been reassigned to me. Affording Petitioner the benefit of the doubt, and assuming that the omission was inadvertent, I sent an e-mail to counsel for the parties on February 12, 2018, in which I gave Petitioner until 5:00 p.m. Eastern Time on March 13, 2018, to complete his filing. Petitioner filed Ms. Mukoro’s affidavit on that date.

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I have reviewed the parties’ contentions and their supporting exhibits, including the belatedly filed affidavit of Ms. Mukoro – P. Ex. 2 – and find no dispute as to the material facts. Consequently, summary judgment is appropriate. I do not receive the parties’ exhibits into evidence inasmuch as I am granting summary judgment. However, I cite to some of the exhibits in order to illustrate undisputed facts or to explain why there are no disputes as to material facts.

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 reasonable.

B. Findings of Fact and Conclusions of Law

Home health agencies participate in the Medicare program subject to the requirements of regulations set forth at 42 C.F.R. Part 484. These requirements include the condition set forth at 42 C.F.R. § 484.30. Pursuant to this condition, a participating home health agency must 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. 42 C.F.R. § 484.30.

CMS asserts that Petitioner failed to comply with this condition.CMS asserts that Petitioner failed to comply with other conditions of participation but it bases its motion for summary judgment on Petitioner’s alleged failure to comply with 42 C.F.R. § 484.30.  It asserts that Petitioner’s registered nurse violated the condition because she re-used a lancet for drawing blood in order to determine blood sugar levels, in contravention of a professionally recognized standard of care requiring lancets to be used only once and not re-used.

A “lancet” is a fingerstick device that contains a needle that punctures the skin in order to produce sufficient blood in order to measure blood sugar levels.  There are two types of fingerstick devices:  those that are disposed of after a single use and those that are re-useable, but only on a single individual.  Neither device should ever be used on more than one individual.  Both the Centers for Disease Control and CMS have issued guidance

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directing that these devices never be used on more than one person 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.

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.  In using the lancet in that manner, the possibility exists that a tiny 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.  Wiping a lancet with alcohol between uses is not effective disinfection because it may not remove potentially embedded blood.  Id. at 3.

A surveyor interviewed Ms. Mukoro, who admitted that she brought equipment with her on home health visits for purposes of checking beneficiaries’ blood glucose levels.  CMS Ex. 22 at 3.  The nurse stated that she believed that wiping the outside of a lancet between uses with a disinfecting wipe was sufficient to clean the lancet and to make it ready for re-use.  Id.  She averred that this was the procedure that she followed when she checked blood glucose levels of beneficiaries served by Petitioner.  Id.

Ms. Mukoro’s testimony neither adds material facts to, nor does it contradict, anything that she stated in her interview with the surveyor.  See P. Ex. 2.  Most significantly, Ms. Mukoro does not deny that she re-used lancets on multiple beneficiaries.  In her affidavit Ms. Mukoro asserts that the surveyor was biased against Petitioner, but that assertion raises no material facts that affect the outcome of this case.  Id.

The surveyor also interviewed beneficiaries served by Petitioner.  Several beneficiaries told the surveyor that they did not check their own blood sugar levels but that they were checked by Petitioner’s nurse during home health visits and that the nurse used her equipment to perform the checks.  CMS Ex. 22 at 3-4.

The only reasonable inference that I can draw from these facts is that Petitioner’s nurse re-used lancets to perform blood sugar checks.  The nurse did not deny re-using lancets.  More significantly, she told the surveyor that she cleaned the lancets between uses.  There would be no point whatsoever to cleaning the lancets if the nurse did not re-use them.

Furthermore, the nurse admitted to using an ineffective technique to clean the lancets.  As I have discussed, wiping a lancet with alcohol between uses does not guarantee that small quantities of blood embedded at the opening of the lancets’ metering devices are removed.  Consequently, blood and any pathogens within that blood may be transmitted from beneficiary to beneficiary even if the lancets are wiped down between uses.

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I find that Petitioner’s re-use of lancets on multiple patients clearly violated the requirements of 42 C.F.R. § 484.30.  That regulation requires that home health agency services meet professionally recognized standards of care, described in the regulation as appropriate preventative and rehabilitative procedures.  Re-using lancets on multiple beneficiaries is a clear and flagrant violation of professionally recognized standards.  The practice is in plain violation of Centers for Disease Control and CMS advisories, advisories that should be known by every home health agency and its staff.

Re-use of lancets – even those that have been wiped with a disinfectant between uses – poses great danger for patients.  There is the possibility that blood-borne pathogens, including pathogens that cause hepatitis, may be transmitted in this manner.  Petitioner’s re-use of lancets put its beneficiaries at great risk of harm.

Petitioner asserts as a fact that none of its nurses “at any time, use the same lancing device on multiple patients.”  Petitioner’s pre-hearing brief at 1.  That is an assertion of fact, which, if supported by evidence, would be reason for me to deny CMS’s motion for summary judgment.  However, as Petitioner offered no evidence whatsoever to support its contention, it is a bald denial without support. 

Moreover, I note that Petitioner’s counsel’s characterization in Petitioner’s pre-hearing brief of the purported testimony of Ms. Mukoro provides no basis to find a genuine dispute about a material fact.  In the brief, counsel avers 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 . . . .

Petitioner’s pre-hearing brief at 6. As I have stated, Ms. Mukoro’s affidavit does not establish material facts in dispute. See P. Ex. 2. In her affidavit, Ms. Mukoro does not deny re-using lancets nor does she “emphatically deny” cleaning used lancets by wiping them with an alcohol saturated swab. Indeed, Ms. Mukoro does not address the allegations concerning re-use of lancets.

In its initial determination, 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. CMS devotes part of its brief to defending this determination and Petitioner, equally, attacks it. However, and as CMS acknowledges, a finding of immediate jeopardy-level noncompliance is not a necessary element of this case nor of my decision.

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Regulations authorize imposition of civil money penalties against home health agencies such as Petitioner 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).

When CMS determines to impose a per-instance civil money penalty, the penalty amount may range from $1000 to $10,000.  42 C.F.R. § 488.845(b)(6).  That range applies whether or not immediate jeopardy is present.

I do not make a finding that Petitioner’s noncompliance comprised immediate jeopardy for Medicare beneficiaries inasmuch as it is unnecessary that I do so.  Rather, I review the penalty amount of $10,000 in the context of regulatory criteria governing imposition of civil money penalties.  Those criteria include the seriousness of an entity’s noncompliance.  42 C.F.R. § 488.815. 

Petitioner’s noncompliance was especially egregious.  Re-use of lancets violates all accepted standards of nursing practice.  It is dangerous to patients because re-use of lancets – even when a practitioner attempts to disinfect them between uses – poses a risk of transmitting blood-borne pathogens such as the hepatitis virus from one individual to the next.  Re-use is specifically prohibited by applicable guidelines published by the Centers for Disease Control and CMS.  CMS Ex. 21.  Any nurse should be aware of these guidelines because complying with them is an integral element of professional nursing care.  Petitioner’s noncompliance put Medicare beneficiaries at great risk.  A penalty of $10,000 is entirely reasonable given the potentially dangerous consequences of Petitioner’s noncompliance.

Petitioner argues that CMS’s remedy choice is arbitrary and unsupported by the undisputed material facts.  I disagree.  There is nothing arbitrary about this remedy choice; it is well grounded on the seriousness of Petitioner’s noncompliance and the danger that this noncompliance posed for Medicare beneficiaries.  Petitioner also challenges the methodology used by surveyors, contending that the surveyor’s actions were unfair to Petitioner.  That is not a meaningful challenge to the surveyor’s findings.

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The surveyor, and CMS, adduced evidence that Petitioner was noncompliant with regulatory requirements.  That shifted the burden to Petitioner to rebut that evidence, regardless of the evidence’s provenance.  Petitioner failed to offer any material facts or evidence that constitute a rebuttal.