Sun West Choice Healthcare and Rehabilitation, DAB CR6254 (2023)

DECISION

Sun West Choice Healthcare and Rehabilitation (Petitioner or “the facility”) challenges the determination by the Centers for Medicare & Medicaid Services (CMS) that its conceded noncompliance with the Medicare program participation requirements regarding infection control (42 C.F.R. § 483.80(a)(1), (2), (4); (f)) (cited as Tag F-880)¹ amounted to immediate jeopardy to resident health and safety.  To the extent a favorable decision regarding the immediate jeopardy determination would result in a lower applicable civil monetary penalty (CMP) range, Petitioner also challenges the CMP imposed.

For the following reasons, I uphold CMS’s determination that Petitioner’s noncompliance with the Medicare participation requirements for infection control caused immediate jeopardy to resident health and safety.  I uphold the $20,265 CMP, which is based in part on a per-day CMP of $8,935 for one day of immediate jeopardy noncompliance.

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I. Background

The Social Security Act (Act) establishes requirements for skilled nursing facility (SNF) participation in the Medicare program and authorizes the Secretary of Health and Human Services (“the Secretary”) to promulgate regulations implementing those statutory provisions.  See 42 U.S.C. § 1395i-3; 42 C.F.R. pts. 483 and 488.  To participate in the Medicare program, SNFs must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, any deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “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 participation requirements.  42 U.S.C. § 1395aa(a); 42 C.F.R. §§ 488.10, 488.20.  The Act and its implementing regulations require that facilities be surveyed on average every twelve months, and more often if necessary, to ensure that identified deficiencies are corrected.  42 U.S.C. § 1395i‑3(g)(2)(A); 42 C.F.R. §§ 488.20(a), 488.308.  During the COVID-19 pandemic, surveyors conducted focused infection control surveys of SNFs to investigate compliance with Medicare participation requirements pertaining to infection control, as occurred with Petitioner.  See CMS Memorandum QSO-20-20-All (March 20, 2020) (“Prioritization of Survey Activities”), https://www.cms.gov/files/document/qso-20-20-allpdf.pdf-0 (last visited Feb. 28, 2023); see also CMS Ex. 3.

CMS may impose a per-day CMP for the number of days a facility is not in substantial compliance or a per-instance CMP for each instance of the SNF’s noncompliance.  42 U.S.C. § 1395i-3(h)(2)(B)(ii); 42 C.F.R. § 488.430(a).²  If CMS imposes a remedy based on a noncompliance determination, then the facility may request a hearing before an administrative law judge (ALJ) to challenge the noncompliance finding and enforcement remedy.  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).

A CMS surveyor conducted a COVID-19 focused infection control survey of the facility on July 8, 2020, and cited immediate jeopardy noncompliance³ with the Medicare

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program participation requirements found at 42 C.F.R. § 483.80(a)(1), (2), (4); (f) (cited as Tag F-880) at the “K” level scope and severity.⁴  CMS Ex. 1 at 2; see CMS Ex. 17 at 1.  The surveyor drafted a statement of deficiencies, Form CMS-2567, that identified immediate jeopardy on July 8, 2020.  CMS Ex. 1 at 1; see CMS Ex. 19 at 2, 14 (testimony of surveyor).  Petitioner abated immediate jeopardy that same day.  CMS Ex. 1 at 1.

In a letter dated July 24, 2020, CMS explained that, on July 8, 2020, the survey team found an immediate jeopardy situation that was abated that same day.  CMS Ex. 17 at 1.   CMS determined Petitioner continued to remain out of substantial compliance after it abated immediate jeopardy.  CMS Ex. 17 at 1-2.  CMS imposed a per-day CMP of $8,935 for the single day of immediate jeopardy noncompliance on July 8, 2020, and a per-day CMP of $515 thereafter that would remain in effect until Petitioner returned to substantial compliance.  CMS Ex. 17 at 2-3.

Petitioner timely requested a hearing on September 22, 2020.  CMS filed a pre-hearing brief, along with 20 proposed exhibits (CMS Exs. 1-20), and Petitioner filed a pre-hearing brief and 24 proposed exhibits (P. Exs. 1‑24).  CMS filed a reply brief and evidentiary objections.  In a May 5, 2021 order summarizing a May 4, 2021 pre-hearing conference, I sustained CMS’s objections to P. Exs. 1, 2, 4, 5, 6, and 7, and overruled CMS’s objections to P. Exs. 12, 13, 16, and 19.  At that time, I admitted CMS Exs. 1-20 and P. Exs. 3 and 8-24 into the evidentiary record, with CMS Ex. 19 and P. Exs. 22 and 23 being provisionally admitted into the evidentiary record pending the appearance of the witnesses for cross-examination at the hearing.  The witnesses were cross-examined at a videoteleconference hearing on August 12, 2021, and I therefore admit CMS Ex. 19 and P. Exs. 22 and 23 in addition to the previously admitted evidentiary exhibits.

Following the hearing, a transcript (Tr.) of the hearing was made available to the parties.  Thereafter, the parties both filed post-hearing briefs (CMS Post-Hrg. Br. and P. Post-Hrg. Br.) and post-hearing reply briefs (CMS Post-Hrg. Reply; P. Post-Hrg. Reply).  The record is closed and the case is ready for a decision.

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II. Issues

At the May 4, 2021 pre-hearing conference, the parties agreed that the following issues are presented for review: 

Whether the determination of immediate jeopardy for Petitioner’s noncompliance with 42 C.F.R. § 483.80(a)(1), (2), (4); (f) (cited as Tag F-880) was clearly erroneous?

Whether the $20,265 CMP is reasonable to the extent it is based, in part, on immediate jeopardy noncompliance?

See May 5, 2021 Order Summarizing Pre-Hearing Conference; Tr. at 3.

III. Discussion⁵

1. 1. Petitioner has a written infection control policy addressing the cleaning and decontamination of glucometers⁶ that states, “[I]f no visible organic material is present, disinfect after each use the exterior surfaces following the manufacturer’s directions or may use a cloth/wipe with either an EPA-registered detergent/germicide with a tuberculocidal or HBV/HIV label claim, or a dilute bleach solution of 1:10 (one part bleach to 9 parts water) to 1:100 concentration.”
2. 2. Petitioner’s Director of Nursing, Ms. Shoemaker, testified that the facility had an established procedure in place prior to July 8, 2020, directing the “precise steps to follow when using a glucometer and when sterilizing it after it has been used.” These steps included that staff “[p]lace barrier on surface intended for use during procedure, and place glucometer on the barrier,” “[p]lace the used glucometer on a barrier on the medcart for cleaning and sterilization before next use,” and that staff “[w]ash hands,” “[p]ut gloves on,” “[w]ipe glucometer with the bleach wipe,”  and “[u]se a second bleach wipe to wrap the glucometer, and allow it to sit for five minutes (or as per the manufacturer’s instructions on the bleach wipe).”

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3. 3. CMS conducted a focused infection control survey on July 8, 2020, at which time a surveyor observed a nurse, Ms. Hessley, use the same glucometer on two different residents.
4. 4. The surveyor observed that Ms. Hessley “failed to sanitize/disinfect a glucometer . . . between use on residents” and that “blood glucose testing supplies were contaminated when moved from one resident room to another and from one medication cart to another without sanitization or use of a barrier.”
5. 5. Petitioner concedes that Ms. Hessley “mistakenly failed to sanitize the glucometer” between uses on different residents and “failed to set up a barrier for the glucometer both in the resident room and on the medication cart.”
6. 6. Petitioner submitted a “Skills checklist – Nurse” that listed an evaluation date of November 20, 2019, that purports to show that Ms. Shoemaker evaluated the skills of Ms. Hessley on November 20, 2019, upon her hiring by the facility.
7. 7. Both Ms. Shoemaker and Ms. Hessley testified on cross-examination that Ms. Shoemaker completed the evaluation form when observing Ms. Hessley on November 20, 2019.
8. 8. Because the form lists a date of “5/2020” and references evaluation of the skill of “Covid-19, signs & symptoms, PPE [personal protective equipment] and droplet precautions,” it is not credible that Ms. Shoemaker evaluated Ms. Hessley’s skills with that form on November 20, 2019, which would have been at a time when COVID-19 had neither been identified nor been the subject of any facility policy.
9. 9. Because Ms. Shoemaker and Ms. Hessley provided materially false statements, I have determined that their testimony that Petitioner trained and evaluated Ms. Hessley’s competency in various nursing skills, to include the use of a glucometer with proper infection prevention measures, on November 20, 2019, is not credible.
10. 10. A failure to disinfect a glucometer between uses and the failure to use a barrier between the glucometer and testing supplies and surfaces, such as tables, pose a risk of bloodborne illness through exposure to blood-contaminated supplies and equipment.

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11. 11. Petitioner failed to comply with 42 C.F.R. § 483.80(a)(1), (2), (4); (f) when it did not establish 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 disease and infections during testing with glucometers.
12. 12. A failure to disinfect a shared glucometer, or cross-contamination of testing supplies and surfaces with a blood sample obtained for use in the glucometer, can expose residents to bloodborne illnesses such as hepatitis and HIV, and these illnesses can cause serious harm or death.
13. 13. Petitioner had 24 residents who received daily capillary blood glucose (CBG) monitoring through the facility’s use of shared glucometers.
14. 14. Petitioner has not demonstrated that the finding that Petitioner’s deficient practices caused immediate jeopardy to the health and safety of the 24 residents who received daily CBG monitoring is clearly erroneous.

The July 8, 2020 survey

During the July 8, 2020 focused infection control survey, the surveyor observed a facility licensed practical nurse (LPN), Ms. Hessley, perform CBG testing on residents.  CMS Ex. 19 at 10-12.  As relevant to the immediate jeopardy finding that is the subject of this decision, the Form 2567 statement of deficiencies summarized the basis for the surveyor’s determination:  

Based on observation, interview, and record review the facility failed to implement basic infection control practices to prevent transmission of blood borne pathogens during 2 of 2 observations when staff performed blood glucose monitoring for Residents R1 and R2.  The facility failed to sanitize/disinfect a glucometer (device to test blood glucose) between use on residents.  Additionally[,] blood glucose testing supplies were contaminated when moved from one resident room to another and from one medication cart to another without sanitization or use of a barrier.  Twenty four residents who required blood glucose testing were placed at risk for serious and potentially life-threatening blood-borne illness which constituted immediate jeopardy. 

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CMS Ex. 1 at 4.  The surveyor, via the Form 2567 statement of deficiencies, provided a detailed discussion of her observations regarding the performance of CBG testing by Ms. Hessley, stating: 

During observation . . . at 11:13 AM [Ms. Hessley] prepared supplies to perform a blood glucose test on [Resident # 1] . . . [Ms. Hessley] carried a container of glucose test strips, 3 lancets (to puncture the skin) and the glucometer in her hands.  [Ms. Hessley] stepped into [Resident # 1’s] room and placed the supplies directly on the bedside stand.  [She] did not place a barrier on the bedside stand. . . .

[Ms. Hessley] opened the bottle of test strips and inserted a strip into the machine. [She] used one lancet to prick the skin and squeezed the finger to form a droplet of blood. [She] held the glucometer up to [Resident # 1’s] finger to allow blood to run into the test strip. [Ms. Hessley] then placed the glucometer with the test strip still in it back on the bedside table while she removed her gown and gloves. [She] used hand sanitizer then carried the glucometer, the test strip container and the lancets in her hand. [She] discarded the used lancet in the sharps container and placed the test strips, remaining two lancets, and glucometer directly on the surface of the medication cart with no barrier and no cleaning or disinfection of the glucometer.

* * * *

At 11:21 AM [Ms. Hessley] took the contaminated glucometer, test strips, and two lancets from the medication cart to [Resident # 2’s] room and placed them on the over bed table with no barrier. [She] donned a gown and gloves and performed the blood glucose test on [Resident # 2], inserting the test strip, lancing the finger, and holding the glucometer up to the droplet of blood on the finger . . . . [She] placed the unused lancet and the glucometer on the medication cart with no barrier and no cleaning or sanitization of the glucometer.

[Ms. Hessley] wheeled the medication cart down the corridor to the nursing station where [another nurse] sat. [Ms. Hessley] asked [the other nurse] if she had bleach wipes and [the other nurse] said she did. [Ms. Hessley] moved the

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contaminated glucometer to [the other nurse’s] medication cart. . . . [She] did not place a barrier on the medication cart.

CMS Ex. 1 at 5-6; see CMS Exs. 2 at 2 (staff identifier list referring to Ms. Hessley as “LN2”); 19 at 10-13 (surveyor’s testimony regarding the observations she reported in the statement of deficiencies).  The surveyor reported that Ms. Hessley “admitted that she had forgotten to disinfect” the glucometer between uses between Resident # 1 and Resident # 2 and also “admitted that sanitizing the medication cart in light of the fact that the contaminated glucometer had sat on it was ‘probably a good idea.’”  CMS Ex. 19 at 13 (surveyor testimony); see CMS Ex. 1 at 6.

In her testimony, Ms. Hessley stated that she “[did] not dispute the entirety of the description of [her] conduct,” but claimed “there is certain information included in the document that [she does] not believe is fully accurate.”  P. Ex. 22 at 4, 5.  Ms. Hessley did not dispute that she did not clean the glucometer between uses, nor did she dispute that she did not use a barrier between the glucometer and the surface upon which it was placed.  P. Ex. 22 at 6 (“I believe I clearly articulated that [the glucometer] should have been disinfected between residents with bleach wipes; that a barrier should have been placed when placing the glucometer or other items on both the bedside table and the medication cart; and that the cart should have been sanitized if exposed to the used glucometer.”); see P. Br. at 3 (“During the course of performing this task, Ms. Hessley mistakenly failed to sanitize the glucometer between Resident 1 and Resident 2, and failed to set up a barrier for the glucometer both in the resident room and on the medication cart.”).  Ms. Hessley claimed that the surveyor’s observations “are not representative” of the way she normally performs these tasks and “are the product of nerves and anxiety in the context of the survey process, and are outliers.”  P. Ex. 22 at 5.  Ms. Hessley stated that “it seems more appropriate and fair to consider the manner in which [she has] performed blood glucose checks on the literally tens of thousands of occasions prior to that day.”  P. Ex. 22 at 5-6.

Facility policies and procedures

Petitioner claims that it “has, and had at the time of the July 8, 2020[] survey, a robust, comprehensive, and compliant infection prevention and control program.”  P. Br. at 6, citing P. Ex. 9 (identified in Petitioner’s list of exhibits as “Sun West Choice Infection Prevention and Control Policies”).  Included in these policies is an infection control policy and procedure, last revised in July 2013, that addressed the cleaning and decontamination of glucometers.  P. Ex. 9 at 23-24; see CMS Ex. 7.  The policy stated that “[i]f no visible organic material is present, disinfect after each use the exterior surfaces following the manufacturer’s directions or may use a cloth/wipe with either an EPA-registered detergent/germicide with a tuberculocidal or HBV/HIV label claim, or a dilute bleach solution of 1:10 (one part bleach to 9 parts water to 1:100 concentration).” 

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P. Ex. 9 at 23.  The policy did not address the use of barriers between the contaminated glucometer and any surface upon which it was placed.  P. Ex. 9 at 23-24.

In testimony submitted on March 12, 2021, Petitioner’s Director of Nursing, Ms. Shoemaker, testified that she “worked hard to develop, revise, augment and implement various clinical policies, procedures and protocols,” to include “the Facility nursing staff approach [to] the use and sanitization of devices, like blood glucometers.”  P. Ex. 23 at 2.  Ms. Shoemaker recognized that “[t]he potential for infection control issues relative to these devices is well-known to [her], and the Facility protocols surrounding their use were designed to maximize infection prevention.”  P. Ex. 23 at 2.  Ms. Shoemaker testified that staff “is trained on the precise steps to follow when using a glucometer and when sterilizing it after it has been used.”  P. Ex. 23 at 2.  Rather than citing to a written policy, Ms. Shoemaker recited a multi-step procedure in her testimony, explaining the steps as follows: 

1. Gather all items needed to perform the check, including the glucometer, the lancet, an alcohol wipe (for the resident’s finger) and the strip.
2. Also have a barrier (e.g., a piece of wax paper or a paper towel) and bleach wipes readily available.
3. Wash hands before entering the resident’s room and don gloves.
4. Place barrier on surface intended for use during procedure, and place glucometer on the barrier.
5. Identify the resident.
6. Use an alcohol wipe to sterilize the finger.
7. With the lancet, prick the resident’s finger to obtain a droplet of blood.⁷
8. Transfer the droplet of blood from the finger to the glucometer.⁸

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9. Read the blood sugar result.
10. Apply band-aid to resident’s finger.
11. Remove gloves and wash hands.
12. Place the used glucometer on a barrier on the medcart for cleaning and sterilization before next use.⁹
13. To clean the glucometer:
    1. Wash hands
    2. Put gloves on
    3. Wipe glucometer with the bleach wipe
    4. Use a second bleach wipe to wrap the glucometer, and allow it to sit for five minutes (or as per the manufacturer’s instructions on the bleach wipe).

Ex. 23 at 2-3. Ms. Shoemaker testified that “[t]his procedure was in place prior to the survey o[n] July 8, 2020, and is/was the subject of training for our nursing staff both at the time of hire and annually thereafter.”¹⁰ P. Ex. 23 at 3

With precise recall of the apparently unwritten procedure, as evidenced by her use of  identical language to that of Ms. Shoemaker,¹¹ Ms. Hessley testified that she “was trained by and at Sun West Choice to take the following steps” (P. Ex. 22 at 2) in connection with obtaining blood sugar readings with glucometers: 

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1. Gather all items needed to perform the check, including the glucometer, the lancet, an alcohol wipe (for the resident’s finger) and the strip.
2. Also have a barrier (e.g., a piece of wax paper or a paper towel) and bleach wipe readily available.
3. Wash hands before entering the resident’s room and don gloves.
4. Place barrier on surface intended for use during procedure, and place glucometer on the barrier.
5. Identify the resident.
6. Use an alcohol wipe to sterilize the finger.
7. With the lancet, prick the resident’s finger to obtain a droplet of blood.
8. Transfer the droplet of blood from the finger to the glucometer.
9. Read the blood sugar result.
10. Apply band-aid to resident’s finger.
11. Remove gloves and wash hands.
12. Place the used glucometer on a barrier on the medcart for cleaning and sterilization before next use.¹²

Ex. 22 at 2-3.

Petitioner concedes noncompliance with the Medicare participation requirements at 42 C.F.R.  § 483.80 and does not dispute CMS’s determination of noncompliance.

Pursuant to 42 C.F.R. § 483.80, Petitioner was required to “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.” 

Petitioner frames the issue on appeal as “whether the non-compliance identified by the surveyor on July 8, 2020, constituted ‘immediate jeopardy’ as that term is defined and described in revised Appendix Q of the State Operations Manual . . . for the purposes of assigning a scope and severity level of ‘K’ to the claimed deficient practice.”  P. Br. at 5.  Petitioner concedes the noncompliance cited involving the observations of Ms. Hessley’s use of a glucometer on July 8, 2020.  See Tr. at 3 (my discussion of the framing of the issues that was agreed upon by the parties during the pre-hearing conference, to include

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Petitioner’s conceded noncompliance with 42 C.F.R. § 483.80).  Petitioner does not dispute the observations of the surveyor that are the factual basis for the citation of immediate jeopardy, stating the following in its brief: 

[The surveyor] proceeded to monitor the activity of [Ms. Hessley] . . . as she initiated blood glucose checks of residents assigned to her care that morning . . . During the course of performing this task, Ms. Hessley mistakenly failed to sanitize the glucometer between Resident 1 and Resident 2, and failed to set up a barrier for the glucometer both in the resident room and on the medication cart. . . .

The reason Ms. Hessley made the isolated error was not because she lacked knowledge on the process and protocol to follow when performing blood sugar checks and/or using/sanitizing a glucometer . . . Rather, the etiology of the error was her anxiety and nervousness associated with being the subject of a surveyor observation.

P.Br. at 3; see P. Post-Hrg. Br. at 2-3 (essentially verbatim passage).

The statement of deficiencies, along with the testimony of the surveyor, reported that the facility had 24 residents who required CBG monitoring.  CMS Exs. 1 at 1; 19 at 14.  Petitioner has not disputed this figure.  See P. Br. at 4.

To participate in the Medicare program, a facility must maintain substantial compliance with program participation requirements.  In order to be in substantial compliance, deficiencies may “pose no greater risk to resident health or safety than the potential for causing minimal harm.”  42 C.F.R. § 488.301.  “Noncompliance” means “any deficiency that causes a facility to not be in substantial compliance.”  Id.  Petitioner’s noncompliance exposed residents to the risk of infection, and therefore, posed more than a minimal risk to resident health and safety.  CMS Ex. 1 at 7-8 (citing Centers for Disease Control and Prevention (CDC) guidance submitted as CMS Ex. 16 at 1) (“An underappreciated risk of blood glucose testing is the opportunity for exposure to bloodborne viruses (HBV, hepatitis C virus, and HIV) through contaminated equipment and supplies if devices used for testing (e.g., blood glucose meters, fingerstick devices) are shared.  Outbreaks of hepatitis B virus (HBV) infection associated with blood glucose monitoring have been identified with increasing regularity particularly in long-term care settings.”); see also CMS Ex. 16 at 2 (CDC discussion of “unsafe practices” in CBG monitoring, to include “[u]sing a blood glucose meter for more than one person without cleaning and disinfecting it in between uses,” and that such practice has contributed to transmission of hepatitis B or the “risk for infection”); P. Post-Hrg. Reply at 8 (Petitioner’s acknowledgment that the development of a bloodborne illness “is serious”). 

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Petitioner’s failure to disinfect a glucometer between uses, alone, placed residents at risk of bloodborne infection and amounted to noncompliance with 42 C.F.R. § 483.80.

Petitioner disputes “the findings and conclusions generated from the Federal Survey . . . as they relate to the conclusion that a situation of Immediate Jeopardy existed with respect to the staff use of the glucometer between Residents 1 and 2 during a single observation.”  P. Br. at 1 (bold font omitted).  Petitioner primarily argues that the noncompliance stemmed from an “isolated mistake initiated in connection with [Ms. Hessley’s] fear/anxiety, rather than as a result of a broken system or a generalized lack of knowledge regarding glucometer use and sanitization.”  P. Br. at 2.  Petitioner also argues that there is an “absence of actual or probable harm to either of the involved Residents,” and therefore, a citation at the “K” level (pattern) of scope and severity “should be reduced to an ‘E’ as per the relevant scope and severity grid.”  P. Br. at 1-2.   Apparently not appreciating its burden of proof, Petitioner also argues that “CMS did not and cannot demonstrate that any recipient of care has suffered or is likely to suffer serious injury, serious harm, serious impairment or death relative to the deficient practice.”  P. Br. at 3.

The facts here are not complicated.  Petitioner submitted testimonial evidence that it trains its staff to perform a step-by-step procedure for CBG monitoring that incorporates infection control measures that would be expected to prevent the transmission of bloodborne illnesses.  P. Exs. 22 at 2-3; 23 at 2-3.  Although this purported procedure has apparently not been reduced to a written facility policy, both facility witnesses provided identical recitations of the procedure.  P. Exs. 22 at 2-3 (Ms. Hessley’s testimony regarding steps “a” through “l” of the procedure); 23 at 2-3 (Ms. Shoemaker’s identical testimony regarding “the precise steps” that staff are trained to follow, to include steps “a” through “l,” along with an additional “m” (“To clean the glucometer” and its four subparts); but see P. Exs. 9 (26 pages of documents identified by Petitioner as its “Infection Prevention and Control Policies” that do not include the procedure discussed by the witnesses); 11 (outlining a protocol that was not discussed by Petitioner’s witnesses).  Despite staff purportedly being trained to perform the “precise steps” outlined in this procedure, a surveyor observed multiple deviations from the procedure, to include the complete failure to disinfect the glucometer between uses on different residents and the placement of the contaminated glucometer, along with the testing supplies, directly on surfaces, such as medication carts, a bedside table, and an over-the-bed table, without a barrier to prevent cross-contamination.  See CMS Ex. 1 at 5-6.  And despite Petitioner’s claim that this noncompliance was “isolated” and not a systemic failure, there is no credible support for this claim.  See P. Br. at 10 (“This is certainly not the kind of ‘egregious noncompliance,’ systemic failure, or incompetence contemplated by other Tribunals when upholding an immediate jeopardy finding.”)  Although the nurse claims she appropriately performed CBG checks “literally tens of thousands of occasions prior to that day” and that her multiple infection control lapses during observation by the surveyor were merely due to nervousness or anxiety, neither the nurse nor the Director of Nursing has offered credible testimony that the nurse was, in fact, trained to correctly

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perform CBG monitoring and had her competency verified.  Neither witness’s claim regarding the facility’s purported extensive training and competency evaluation process is credible because both witnesses draw support from fabricated evidence, as I discuss below.  See P. Ex. 14; see P. Exs. 22, 23.

Petitioner relies on fabricated evidence to show that Ms. Hessley was trained to perform CBG monitoring in accordance with a facility procedure and demonstrated competency in the performance of CBG monitoring on November 20, 2019.

Petitioner claims that the observed infection control deficiencies were an “isolated error” and “not because [Ms. Hessley] lacked knowledge on the process and protocol to follow when performing blood sugar checks and/or using/sanitizing a glucometer.”  P. Br. at 3; see P. Post-Hrg. Br. at 7 (“Ms. Shoemaker affirmed Ms. Hessley’s competence in this same area with her testimony, leaving no doubt that what happened on the day of the survey was an aberration.”).  The Director of Nursing, Ms. Shoemaker, testified that the facility trained its nursing staff on its infection control procedures involving glucometer use at the time of hire.  P. Ex. 23 at 3.  Ms. Shoemaker testified that she “personally verified and validated the competency of [Ms.] Hessley . . . with respect to her management of blood sugar checks and glucometer cleaning at the time of her hire on November 18, 2019.”  P. Ex. 23 at 3-4.  In support, Ms. Shoemaker cited to P. Ex. 14, which is a “Skills checklist- Nurse” that lists Ms. Hessley’s name with a date of hire of November 18, 2019, and throughout the four-page form, lists numerous competencies that correspond to the handwritten notation of “11/20/19,” indicating that the marked competencies were evaluated on that same date.  P. Ex. 14 at 1-4.  In addition to the handwritten notation of “11/20/19” listed alongside Ms. Shoemaker’s initials on each page of the form, Ms. Shoemaker placed her signature on the last page of the form alongside the handwritten date of “11/20/19.”  P. Ex. 14 at 1-4.  During cross-examination at the hearing, counsel for CMS asked Ms. Shoemaker to confirm that she had signed the skills checklist on November 20, 2019; Ms. Shoemaker answered in the affirmative.  Tr. at 79.  Ms. Shoemaker also explained that the “skills checklist is how [she verifies] the competency of all nurses at Sun West.”  Tr. at 79-80.

Likewise, Ms. Hessley testified that “[a]t the start of [her] employment, [she] participated in extensive training,” and that “following this training, [her] competency in each area was assessed by [her] supervisor, [Ms. Shoemaker], to ensure that [her] skills were consistent with performance expectations.”  P. Ex. 22 at 2.  Like Ms. Shoemaker, Ms. Hessley relied on P. Ex. 14, the nursing skills checklist dated November 20, 2019, to support her statements.  P. Ex. 22 at 2.  Citing the skills checklist, Ms. Hessley testified that “[i]ncluded in this training and return demonstration process were critical principles of infection control,” and that she was “trained and then tested on the Facility’s procedures for performing blood sugar checks on residents, which included the process of cleaning and disinfecting blood glucometers.”  P. Ex. 22 at 2.  On cross-examination, Ms.

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Hessley testified that she signed the skills checklist “when they trained me” on November 20, 2019.  Tr. at 68.

The direct and cross-examination testimony of both Ms. Hessley (P. Ex. 22, Tr. 65-70) and Ms. Shoemaker (P. Ex. 23, Tr. 78-82), along with the evidentiary support for this testimony (P. Ex. 14), are not credible.  Both nurses testified that the skills checklist that was used to evaluate Ms. Hessley’s competency as a nurse, to include her ability to perform CBG monitoring according to the specific multi-step procedure outlined by the witnesses, was completed and signed on November 20, 2019.  These statements are false, and the completed skills checklist submitted as P. Ex. 14 at 1-4 is fabricated evidence.

The skills checklist form submitted as P. Ex. 14 at 1-4 lists a date in the lower left-hand corner.  The font size of that date is quite small, but the date of “5/2020” is unmistakable.  The only reasonable interpretation for such a notation that appears in the lower left-hand corner of each page of a standardized typewritten form is that the form was either created or revised in May 2020.  And if there was any doubt that this form was either created or revised in May 2020, a listed competency on line 13(j) as a sub-element of infection control, “Covid-19, signs & symptoms, PPE and droplet precautions,” could not have existed on November 20, 2019.  P. Ex. 14 at 3.  Yet, Ms. Shoemaker documented on page 3 of the skills checklist, by writing “11/20/19” at the top of the column and drawing an arrow from that date through all the competencies listed below on that page, that Ms. Hessley had demonstrated competency in not only “Covid-19, signs & symptoms, PPE and droplet precautions,” but also “Blood sugar checks,” among numerous other competencies, on November 20, 2019.  P. Ex. 14 at 3.

Petitioner, of course, would not have offered training in “Covid-19, signs & symptoms, PPE and droplet precautions” on November 20, 2019, nor would it have evaluated a nurse’s competency with respect to “Covid-19, signs & symptoms, PPE and droplet precautions” at that time.  Petitioner did not yet have an established COVID-19 policy on November 20, 2019, and did not have such a policy until March 4, 2020.  See P. Ex. 9 at 1 (Petitioner’s “Preparatory Plans and Actions for COVID-19 Outbreak,” identified as “COVID-19 Preparedness Plan 03/04/20” at the bottom of the document).  In fact, COVID-19 was unknown to not just Petitioner on November 20, 2019; COVID-19 was also not yet known to the world.  See https://www.cdc.gov/media/releases/2020/t0117-coronavirus-screening.html (last visited Feb. 28, 2023) (transcript of first CDC COVID-19 media telebriefing on January 17, 2020) (“On December 30th, China reported an outbreak of respiratory disease in Wuhan City, it’s a major transportation hub about 700 miles south of Beijing with the population of more than 11 million people.  An investigation led by local officials identified a new coronavirus as the cause of the outbreak.”); see also https://www.cdc.gov/museum/timeline/covid19.html#Early-2020 (last visited Feb. 28, 2023) (CDC’s chronological report of the history of COVID-19, reporting that on December 12, 2019, “[a] cluster of patients in China’s Hubei Province, in the city of Wuhan, begin to experience the symptoms of an atypical pneumonia-like

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illness that does not respond well to standard treatments.”).  Inasmuch as Petitioner did not have a COVID-19 policy in November 2019, and the first worldwide case of COVID-19 had not yet been documented, it is patently false that Ms. Shoemaker evaluated Ms. Hessley’s competency with “Covid-19, signs & symptoms, PPE and droplet precautions” on November 20, 2019.  P. Ex. 14 at 3; see Tr. at 79 (Ms. Shoemaker’s testimony that she signed the skills competency form on November 20, 2019); 68 (Ms. Hessley’s testimony that she signed the skills competency form in 2019 “when they trained [her] on the 20th”).

In its post-hearing brief, CMS pointedly revealed its concerns regarding the credibility of P. Ex. 14 and Petitioner’s witnesses, stating: 

Additionally, Sun West points to documentation of skills tests that allegedly demonstrate Nurse Hessley’s evaluation and competence at the time of her initial hire in November of 2019.  See P. Ex. 14.  And [Director of Nursing] Shoemaker and Nurse Hessley testified that Nurse Hessley was trained well upon her hire to Sun West in November of 2019, including as to CBG monitoring skills and protocols, and that those skill tests were completed and signed contemporaneously with her hiring and initial training in November 2019.  Tr. 68:11-24; 78:13-24; 79:1-24.  However, this testimony is not credible, because the form that this testimony relies upon appears to not have been in existence at the time of Nurse Hessley’s hire in November 2019 [internal footnote omitted].  In the bottom left hand corner of the form, “5/2020” is printed.  The form’s reference to COVID-19 signs, symptoms, and protocols at P. Ex. 14 at 3 would be consistent with a form that was created or last updated in May of 2020, because the World Health Organization noted the first case of COVID-19 in late December of 2020 [internal footnote omitted].¹³COVID-19 signs, symptoms, and protocols, however, would not be consistent with a document that was created and signed as early as November 20, 2019. Yet, both Nurse Hessley and [Director of Nursing]

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Shoemaker testified that they signed this skills test in November 2019 upon Nurse Hessley’s initial hire.  As such, to the extent this Tribunal would rely on the direct testimony of either of the facility witnesses, it should weigh that testimony in light of the credibility issues presented above.

CMS Post-Hrg Br. at 14-15.  Not only did CMS accuse Petitioner of submitting fraudulent evidence, but it also alleged that Petitioner’s two witnesses lied in their sworn testimony.  Petitioner could have responded to these serious allegations in its post-hearing reply brief, yet instead chose to ignore these allegations.  Petitioner also could have filed a motion to withdraw P. Ex. 14 and the testimony of its witnesses, but it did not pursue that course of action.¹⁴  In the absence of any defense to CMS’s allegations of serious misconduct on the part of Petitioner and its witnesses, which is supported by a review of the evidence, I find that P. Ex. 14 is fabricated evidence and that both Ms. Hessley and Ms. Shoemaker lack credibility as witnesses.¹⁵

Inasmuch as Ms. Hessley lied that she signed P. Ex. 14 on November 20, 2019, I have no reason to find that her testimony is anything other than a self-serving collection of lies.  I reject Petitioner’s claim that the observed infection control failures involving Ms.

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Hessley were an isolated occurrence and were not indicative of a systemic problem.  P. Br. 3, 9-10.  There is simply no credible evidence that Petitioner had determined that Ms. Hessley was competent to perform CBG monitoring in such a manner as to prevent the spread of infection.  Similarly, I reject Petitioner’s claim, based on Ms. Hessley’s testimony, that a nurse who had purportedly performed CBG testing on “literally tens of thousands of occasions” simply forgot numerous fundamental infection control measures solely because of nervousness, fear, or anxiety during the survey process.¹⁶  P. Br. at 2-3; see P. Ex. 22 at 5-6.  I also reject Ms. Shoemaker’s claim that she trained Ms. Hessley to perform CBG testing according to an established facility procedure on November 20, 2019, and evaluated her competency that same day.¹⁷  See P. Ex. 23 at 3-4.  I likewise reject Ms. Shoemaker’s claim that she developed, revised, augmented, and implemented clinical policies, to include “the use and sanitization of devices, like blood glucometers,” such that she trained and evaluated the skills of staff performing those competencies.  P. Ex. 23 at 2-3.  If Ms. Shoemaker is willing to lie about assessing Ms. Hessley’s competency on November 20, 2019, then there is simply no reason she would not lie about similar matters.  In short, Petitioner has not submitted credible evidence that it trained and evaluated its staff to ensure that they performed CBG monitoring in a manner that was consistent with the infection control requirements of 42 C.F.R. § 483.80.  The surveyor’s observation of Ms. Hessley confirmed a repeated inability to perform CBG monitoring without exposing residents to serious harm through exposure to bloodborne illnesses, whether through failing to disinfect the glucometer between uses on different residents or repeatedly risking cross-contamination by placing the testing supplies and a non-disinfected glucometer directly on multiple surfaces, to include the medication carts and tables in residents’ rooms.

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Petitioner has not demonstrated that CMS’s determination that the 24 residents who were subject to daily CBG monitoring were exposed to a likelihood of serious harm through deficient practices that included lack of disinfection of the glucometer and a failure to prevent potential cross-contamination is clearly erroneous.

Petitioner claims that Ms. Hessley’s egregious infectious control lapses did not expose Resident # 1 and Resident # 2 to a likelihood of serious harm.  See P. Br. at 3, 13-16.  Petitioner relies on cursory identical statements by the physician for both Resident # 1 and Resident # 2 that “[t]here is no evidence based information to support that this deficient practice would result in serious injury, harm, impairment or death of this patient.”  P. Br. at 15, citing P. Exs. 12 at 4; 13 at 4.  Even assuming, only for the sake of discussion, that Resident # 1 and Resident # 2 were not exposed to a likelihood of serious harm, Petitioner ignores that immediate jeopardy was cited for the risk to the health and safety of all 24 residents who were subject to daily CBG testing.  CMS Ex. 1 at 1 (“Deficient infection control practices related to blood glucose testing placed 24 residents who required blood glucose testing at risk for exposure to and potential for infection with blood-borne pathogens which constituted immediate jeopardy.”); see P. Br. at 13-16.  The surveyor, in calling immediate jeopardy at that time, recognized that Petitioner had 24 residents who had CBG monitoring up to four times per day, to include high-risk residents who were on dialysis.  See CMS Exs. 6 at 11 (surveyor notes); 19 at 6, 19-20; Tr. at 17; see CMS Ex. 15 (CDC’s discussion of the increased risk of infection for dialysis patients).  To the extent Petitioner attempts to belatedly address the scope of the immediate jeopardy to include the likelihood of serious harm faced by all 24 residents who received daily CBG monitoring by a nurse who did not ensure basic infection control measures (i.e., disinfecting the glucometer between uses on different residents), and not just Resident # 1 and Resident # 2, it has not met its burden to demonstrate that CMS’s determination of immediate jeopardy was clearly erroneous.  See P. Post-Hrg. Br. at 12 (arguing that no residents in the facility were positive for Hepatitis B or other bloodborne illnesses, but not citing evidence that the residents had actually been tested for Hepatitis B or other bloodborne illnesses following the requisite incubation period(s)). 

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 Departmental Appeals Board (DAB) directs that the “clearly erroneous” standard imposes on a facility a heavy burden to show no immediate jeopardy and has 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) (citing Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004)).  A facility challenging an immediate jeopardy determination must prove that the harm or threatened harm does not meet any

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reasonable definition of “serious.”  Daughters of Miriam Ctr., DAB No. 2067 at 9 (2007).  

Petitioner argues that the CMS guidance at Appendix PP of the SOM somehow supports its claim that CMS’s immediate jeopardy determination is clearly erroneous.  P. Br. at 7-8, citing P. Ex. 24 (excerpts from CMS Pub. 100-7, SOM, App. PP (Guidance to Surveyors for Long Term Care Facilities)).  This guidance is not supportive of Petitioner’s arguments.  CMS directed that “[i]f fingerstick devices are used on more than one resident, surveyors must cite at this tag and utilize the guidelines in Appendix Q for immediate jeopardy.”  P. Ex. 24 at 2 (bold and italics omitted).  With respect to blood glucose meters, the guidance further states that “[i]f the facility failed to clean and disinfect, per device manufacturer’s instructions, and blood glucose meters are used for more than one resident, surveyors must cite this tag and utilize the guidelines in Appendix Q as it may constitute immediate jeopardy.”  P. Ex. 24 at 3 (italics omitted); see CMS Pub. 100-7, SOM, App. Q, § VI (Calling Immediate Jeopardy) (Rev. 187, eff. Mar. 6, 2019) (“When the surveyor/survey team determines the entity’s noncompliance has caused a serious adverse outcome, or has made a serious adverse outcome likely, and immediate action is needed to prevent serious harm from occurring or recurring, the survey team must consult with their State Agency . . . for confirmation that [immediate jeopardy] exists, and seek direction.”) see also § V(B) (“To determine if there is a likelihood of a serious adverse outcome, the surveyor/survey team uses their professional judgment and takes into account the nature and scope of the identified noncompliance, the particular vulnerabilities of the recipients at risk, and any other relevant factors to determine whether serious harm will likely occur if no corrective action or inadequate action is taken.”).  The fact that CMS guidance provides that the failure to clean a blood glucose meter may constitute immediate jeopardy, rather than must be cited as immediate jeopardy, does not establish that CMS’s citation of immediate jeopardy is clearly erroneous.  Under the circumstances presented here, the surveyor determined that 24 residents faced exposure to bloodborne illness and that immediate action was necessary to remove this risk of serious harm caused by both the failure to disinfect glucometers between uses and the risk of cross-contamination posed by placing glucometers and testing supplies directly on surfaces such as the medication cart (that traveled throughout the facility)¹⁸ and residents’ in-room tables.  See Liberty Commons Nursing & Rehab Ctr. - Johnston, DAB No. 2031 at 19 (2006) (“Immediate jeopardy exists if a SNF’s noncompliance is the type of noncompliance that would likely cause serious injury, harm, impairment, or death if not corrected, even if surveyors did not observe or identify a particular resident who was actually threatened with harm during the survey.”)

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The DAB considered an analogous circumstance in Daughters of Miriam Center, DAB No. 2067, explaining: 

In our view, CMS had ample reason to conclude that [the petitioner’s] noncompliance would likely have caused death or serious harm to Resident 4 in the very near future, but for her fortuitous refusal to accept the insulin injection, or to other residents had the facility not stopped the nurse from administering medications when it did.  The nurse’s multiple errors occurred in the space of a single shift, and they suggested extreme carelessness or gross incompetence.  The error regarding Resident 3 involved an apparent failure to read or interpret properly the physician’s Vancomycin order . . . . The errors involving Resident 4 stemmed from an inexplicable failure by the nurse to identify correctly the patient to whom she was giving the medications.  There is no indication in the record that the nurse’s deficient performance was atypical or an infrequent aberration.

There is also no indication that the nurse’s responsibilities for administering prescription medication extended only to Residents 3 and 4, or that her work was being closely supervised. An incident report prepared by the supervising nurse on the shift when the errors occurred shows that she became aware of the errors only after the contract nurse who made them approached the supervisor to tell her she had made the mistake involving the injection of Vancomycin into Resident 3’s thigh. . . Had the contract nurse not recognized her mistake . . . and reported it, there is no reason for us to conclude, based on the record before us, that she would not have continued to make medication errors indefinitely while contracted to work at the facility.

Daughters of Miriam at 12-13.

In Liberty Commons, which was cited by the DAB in Daughters of Miriam, the petitioner argued that CMS’s immediate jeopardy determination “rests on a purely hypothetical or speculative threat of harm” that a failure to implement latex allergy precautions was likely to cause serious harm, as “CMS produced no evidence that anyone else in the facility at the time was allergic to latex.”  Liberty Commons, DAB No. 2031 at 17.  The DAB explained that the ALJ correctly concluded that the immediate jeopardy finding was

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not clearly erroneous based on the facility’s weaknesses in protecting all residents, explaining: 

We too find this a reasonable inference.  Regardless of whether there were other residents known to have latex allergies at the time, the facility had a policy and procedures for dealing with latex allergies and protecting its residents from exposure to latex.  The medical record forms in evidence also indicate that the facility undertook to document in its records other allergies its residents may have had.  It was not unreasonable for CMS or the ALJ to infer that Liberty Commons’ failure to implement its latex allergy precautions with respect to Resident 2 evidenced a systemic laxity with respect to its allergy precautions – particularly with respect to staff communication – that posed a very real and present threat to other residents who needed protection, whether from latex in particular or other allergens.

Liberty Commons, DAB No. 2031 at 21. 

Similar to the circumstances addressed in Daughters of Miriam and Liberty Commons, Petitioner had a deficient practice that placed a category of residents at risk, specifically, all residents who were subject to CBG monitoring.  Petitioner recognized the attendant risk of improper glucometer use.  See P. Post-Hrg. Reply at 8 (“Briefly on the issue of harm, Sun West is not taking the position that the development of a bloodborne illness is something less than serious.  It is serious.”);¹⁹ P. Ex. 23 at 2 (testimony of Ms. Shoemaker that “[t]he potential for infection control issues relative to these devices is well-known to me, and the Facility protocols surrounding their use were designed to maximize infection prevention.”); CMS Ex. 1 at 1 (plan of correction stating that “[r]esidents requiring blood glucose monitoring have the potential to be affected by failure to follow glucose monitoring infection control and disinfection procedures.”); see also CMS Ex. 16 at 1 (CDC guidance that a “risk of blood glucose testing is the opportunity for exposure to bloodborne viruses (HBV, hepatitis C virus, and HIV) through contaminated equipment and supplies if devices used for testing . . . (e.g., blood glucose meters, fingerstick devices, insulin pens) are shared.”).  Petitioner’s nurse completely failed to employ facility-required infection control measures, as required by 42 C.F.R. § 483.80, when performing CBG monitoring on residents, as evidenced by her failure to disinfect a blood-exposed glucometer between uses and repeated failure to use a barrier to prevent cross-contamination of the medication carts and surfaces in the

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residents’ rooms.  This failure is compounded by Petitioner’s failure to demonstrate that it had ensured that the nurse was competent to provide CBG testing that complied with the standard and transmission-based precautions that it claimed were an established facility procedure.  Had the surveyor not identified Ms. Hessley’s unsafe practices during the survey and not called immediate jeopardy, there is simply no reason to believe that these infection control failures would not have continued when she performed the same procedure on up to 22 other residents who required CBG monitoring.  Petitioner’s laxity in its infection prevention and control program exposed all residents who received CBG monitoring to a risk of infection from bloodborne illness, and Petitioner has not shown that CMS’s immediate jeopardy determination was clearly erroneous.

Finally, I briefly address Petitioner’s proverbial apples-to-oranges argument that other facilities in Arizona with infection control deficiencies relating to CBG monitoring were not cited for immediate jeopardy.  P. Br. at 11-12.  Such arguments do not demonstrate how the citation of immediate jeopardy in this case is clearly erroneous, particularly when CMS guidance unquestionably contemplates that the noncompliance observed during the July 8, 2020 survey may, in fact, amount to immediate jeopardy depending on the circumstances.  See CMS Pub. 100-7, App. PP.  Petitioner has the burden of proving that an immediate jeopardy determination is clearly erroneous, and arguing that some other facilities were not cited with immediate jeopardy relating to CBG monitoring does not meet this high burden.²⁰  See, e.g., Liberty Commons, DAB No. 2031 at 18 (“In other words, under section 498.60(c)(2), CMS’s finding regarding the level of noncompliance must be upheld absent a showing of clear error.”).

15. Petitioner waives any challenge to the reasonableness of the $20,265 CMP.

Inasmuch as I upheld the immediate jeopardy determination, Petitioner does not dispute the $20,265 CMP.  P. Br. at 17 (“Because Sun West disputes the assessed scope and severity, it necessarily disagrees with the imposition of the [CMP] in the amount of $20,265.00.  However, it does not dispute the amount of the [CMP] on a stand alone basis or in connection with the finding, generally, of an immediate jeopardy.”).  I have upheld the immediate jeopardy determination, and Petitioner has therefore waived any dispute as to the reasonableness of the CMP.

IV. Conclusion

For the reasons discussed above, I find that the facility was not in substantial compliance with the Medicare participation requirements, and CMS’s determination of immediate

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jeopardy to resident health and safety on July 8, 2020, is not clearly erroneous.

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Endnotes

¹  The finding of noncompliance included subsection (e) pertaining to the handling, storage, processing, and transport of linens.  CMS Ex. 1 at 3.  CMS concedes that the citation of subsection (e) was “clerical error.”  CMS Pre-hearing Brief (CMS Br.) at 3.  

²  The per-day CMP ranges applicable to this case are $6,808 to $22,320 for immediate jeopardy-level deficiencies and $112 to $6,695 for deficiencies that do not constitute immediate jeopardy.  45 C.F.R. § 102.3 (2020).

³  Immediate jeopardy exists when “the provider’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.

⁴  Scope and severity levels are used by CMS and state survey agencies when selecting remedies.  The scope and severity level is designated by letters A through L.  CMS Pub. 100-7, State Operations Manual (SOM), ch. 7, § 7400.3.1 (Matrix for Scope & Severity)   (Rev. 185, eff. Nov. 16, 2018); see also 42 C.F.R. § 488.408.  As relevant here, a scope and severity level of “K” indicates a pattern of immediate jeopardy to resident health or safety. 

⁵  Findings of fact and conclusions of law are in bold and italics.

⁶  I use the terms “blood glucose meter” and “glucometer” interchangeably throughout this decision. 

⁷  The “precise steps to follow” in this procedure, as listed by the Director of Nursing, do not address where the nurse should place the contaminated lancet after pricking the resident’s finger and how and when the lancet should properly be disposed.  Further, the procedure does not instruct where the unused lancet should be placed prior to the procedure (i.e., on a barrier).  I note that the surveyor observed that Ms. Hessley placed testing supplies directly on both the medication cart and a bedside table without a barrier.  CMS Ex. 1 at 5-6.

⁸  The “precise steps to follow” in this procedure, as listed by the Director of Nursing, direct the nurse to place the resident’s bloody finger against the glucometer, rather than against a test strip inserted in the glucometer.  In fact, the procedure lacks any instruction that a test strip should be inserted into the glucometer.  It is unclear how CBG monitoring would be performed without the use of a test strip.  See P. Ex. 23 at 2 (Ms. Shoemaker’s discussion that a test strip is one of the necessary supplies to perform CBG monitoring).  Further, the procedure does not address where the unused test strip should be placed prior to the procedure (i.e., on a barrier); as I previously noted, the surveyor observed that Ms. Hessley placed testing supplies directly on both the medication cart and a bedside table without a barrier.  CMS Ex. 1 at 5-6.

⁹  The “precise steps to follow” in this procedure, as listed by the Director of Nursing, do not instruct the nurse to remove the used test strip from the glucometer, to include where to place the contaminated test strip upon removal and how to dispose of it.  Further, the policy does not instruct the nurse to ensure that the test strip is removed prior to cleaning the glucometer.

¹⁰  Petitioner submitted an undated “Glucometer use and disinfecting Steps” protocol as P. Ex. 11.  The protocol included that “[e]ach med cart will have two glucometers and a divided tray to hold them,” and the “tray has one side for clean glucometers and [an]other side for dirty glucometers.”  P. Ex. 11 (bold and underline omitted).  Neither of Petitioner’s witnesses addressed this protocol in their testimony, and there no indication that this protocol existed prior to the July 8, 2021 survey.  See P. Exs. 22 at 2-3; 23 at 2-3 (witness discussion of multi-step procedure for CBG monitoring, lacking any reference to the placement of the glucometer in a tray or the requirement to clean the dirty side of the tray with bleach).

¹¹  Petitioner has not submitted any evidence that this procedure has been memorialized in a written facility policy or procedure.

¹²  Unlike Ms. Shoemaker, Ms. Hessley omitted the disinfection portion of the procedure in her recitation of the steps to be taken in connection with performing blood sugar checks on residents.  P. Ex. 22 at 2-3.  Ms. Hessley, like Ms. Shoemaker, did not discuss when a test strip should be inserted and removed from the glucometer, nor did she address the procedure for handling and disposing of contaminated test supplies, to include the contaminated test strip and the lancet.  Compare P. Ex. 23 with P. Ex. 22.

¹³  CMS inaccurately paraphrases the CDC’s timeline; the World Health Organization was informed of “several cases of pneumonia of unknown etiology . . . occurring in Wuhan, China” in December of 2019.  CMS Br. Post-Hrg. Br. at 14; see Centers for Disease Control and Prevention, CDC Museum COVID-19 Timeline, https://www.cdc.gov/museum/timeline/covid19.html#Early-2020 (last visited Mar. 15, 2023).

¹⁴  CMS’s discussion can be viewed as an allegation that Petitioner’s counsel, through the electronic filing of Petitioner’s pre-hearing exchange, submitted false material evidence.  CMS Post-Hrg. Br. at 14-15.  Petitioner’s counsel opted to wholly disregard this allegation.  See California Rules of Professional Conduct, Rule 3.3(a)(3) (addressing obligation to “to take reasonable remedial measures, including if necessary, disclosure to the tribunal.”).

¹⁵  Pursuant to 42 U.S.C. §§ 1320a-7a(c)(4) and 1395i-3(h)(2)(B)(ii), an administrative law judge “may sanction a person, including any party or attorney, for failing to comply with an order or procedure, failing to defend an action, or other misconduct as would interfere with the speedy, orderly, or fair conduct of the hearing.”  Owing to my lack of personal awareness regarding who and/or what entity is specifically responsible for the creation and submission of the fraudulent evidence, along with the current age of the pending request for hearing, I opted to not further delay issuance of a decision in order to address who or what entity may be subject to a sanction.  See Standing Pre-Hearing Order § 16 (“I may sanction any person, to include a party or an attorney, for failing to defend an action, or for other misconduct that interferes with the speedy, orderly, or fair conduct of the hearing.); see also Civil Remedies Division Procedures § 23.  I expect that CMS takes such reports seriously and may wish to consider whether it has tools at its disposal to address dishonesty and misconduct by an enrolled provider and recipient of Medicare funds in connection with its appeal of a CMP, and if so, whether it should investigate whether Petitioner is the entity responsible for such dishonesty and misconduct.

¹⁶  Based on Ms. Hessley’s testimony that she had performed “literally tens of thousands” of CBG tests in the approximately six years she had been licensed as a nurse, it is simply implausible that she would forget multiple infection control steps, to include something as fundamental as cleaning the glucometer before using it on the next resident after she had just “prick[ed] the resident’s finger to obtain a droplet of blood” and “[t]ransfer[red] the droplet of blood from the finger to the glucometer.”  P. Ex. 22, at 2, 6.  A process correctly and consistently repeated “tens of thousands” of times would expectedly be ingrained as a standard routine that would not be subject to multiple deviations.  Ms. Hessley may have performed CBG testing tens of thousands of times, but there is no credible evidence that she employed standard and transmission-based precautions to prevent the spread of infection when doing so.  See C.F.R. § 483.80(a)(2) (requirement that written standards, policies, and procedures include standard and transmission-based precautions to be followed to prevent the spread of infections).

¹⁷  In the absence of evidence of a written policy or procedure, it is dubious whether Petitioner had, in fact, implemented the step-by-step CBG monitoring procedure addressed by both Ms. Hessley and Ms. Shoemaker in their testimony.  P. Exs. 22 at 2-3; 23 at 2-3.

¹⁸  In actuality, the scope of immediate jeopardy could have been greater and cited as widespread, in that the cross-contaminated medication carts would expectedly be used to administer medications to residents who did not receive daily CBG monitoring.

¹⁹  Petitioner has not disputed that illnesses such as Hepatitis B are spread by bloodborne pathogens.

²⁰  Petitioner only reports the facilities that did not receive immediate jeopardy citations; it does not address whether its research uncovered whether any facilities, like itself, had been cited with immediate jeopardy.