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                              Foothills Acres Rehabilitation & Nursing Center, CR6289 (2023)
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Foothills Acres Rehabilitation & Nursing Center, CR6289 (2023)








  
  
    

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





Foothills Acres Rehabilitation & Nursing Center
(CCN: 31-5425)
Petitioner,

v.

Centers for Medicare & Medicaid Services
Docket No. C-20-283Decision No. CR6289May 22, 2023

        
              
    

      DECISION

Petitioner, Foothills Acres Rehabilitation & Nursing Center, was not in substantial compliance with program participation requirements from August 23 through November 4, 2019.  Petitioner was not in substantial compliance due to violations of 42 C.F.R. §§ 483.21(b)(3)(i) and 483.45(c)(4) and (5),1 and the regulatory violations posed a risk for more than minimal harm and, therefore, amounted to noncompliance.  There is a basis for the imposition of enforcement remedies.  The following enforcement remedies are reasonable:  a per instance civil money penalty (PICMP) of $21,393 per instance for one day of immediate jeopardy on August 23, 2019, and a per day CMP of $110 per day for

**Page 2**

73 days of noncompliance for the period August 24 through November 4, 2019, for a total CMP of $29,423.

I.    Background

Petitioner is in Hillsborough, New Jersey, and participates in Medicare as a skilled nursing facility (SNF).  Centers for Medicare & Medicaid Services (CMS) Exhibits (Exs.) 1-2; Joint Stipulation of Facts (Jt. Stip.) at 1 ¶ 1.  From August 19 through 28, 2021, the New Jersey State Department of Health, Office of Long-Term Care (state agency) completed a complaint investigation of Petitioner and found Petitioner was not in substantial compliance with program participation requirements.  CMS Exs. 1-2.  Surveyors concluded that Petitioner violated 42 C.F.R. §§ 483.21(b)(3)(i) (Tag F658), 483.45(c)(1)-(2) and (4)-(5) (Tag F756), 483.45(f)(1) (Tag F759), and 483.80(a)(1)-(2), (4), (e), and (f) (Tag F880) and that the regulatory violations posed a risk for more than minimal harm.  CMS Ex. 1.  The surveyors concluded that the noncompliance under Tags F658 and F756 posed immediate jeopardy for Petitioner’s residents.  CMS Ex. 1 at 1-2, 29-31; CMS Ex. 2.  On October 29, 2019, a revisit survey determined that the facility remained out of substantial compliance under Tag F658, but that the noncompliance under Tag F756 was corrected on October 25, 2019.  A second revisit survey on November 5, 2019, determined that Petitioner returned to substantial compliance effective that day.  CMS Ex. 2 at 1-2.

CMS notified Petitioner of its initial determination by letter dated December 9, 2019.  CMS advised Petitioner that it concurred with the state agency findings of noncompliance and that it was imposing the following enforcement remedies:  a PICMP of $21,393 for one day of immediate jeopardy on August 23, 2019, and a CMP of $110 per day for 73 days of noncompliance for the period August 24 through November 4, 2019.  The total CMP accrued was $29,423.  CMS informed Petitioner that it was imposing the enforcement remedies based on all the deficiencies cited by the state agency, but the CMS letter does not specifically mention the noncompliance alleged under Tags F759 or F880.  CMS Ex. 2 at 1-2.  CMS also informed Petitioner that it was ineligible to conduct a nurse aide training and competency evaluation program.  CMS Ex. 2 at 5.

Petitioner requested a hearing before an administrative law judge (ALJ) on February 6, 2020 (RFH).  The case was assigned to me for hearing and decision on February 13, 2020, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at my direction.  On July 20 through 21, 2021, a hearing was convened by video teleconference and a transcript (Tr.) of the proceedings was prepared.2  CMS offered

**Page 3**

CMS Exs. 1 through 17 that were admitted as evidence, subject to the limitations stated at hearing regarding CMS Exs. 10 and 11.  Tr. vol. 1 at 24-26; Tr. vol. 2 at 241-43.  Petitioner offered Petitioner’s exhibits (P. Exs.) 1 through 7 that were all admitted as evidence.  Tr. vol. 1 at 28.  Post-hearing CMS offered CMS Exs. 18 and 19 as I directed at hearing.  Tr. vol. 1 at 21-23.  Petitioner has not objected to my consideration of CMS Exs. 18 and 19 and they are admitted as evidence.  CMS called the following witnesses:  Surveyor Dawn Stillwell, RN and Surveyor Lisa Roccia, RN.  Petitioner called the following witnesses:  Pinchas Goldblatt, Petitioner’s administrator, and Nelia Adaci, RN who was qualified as an expert witness (P. Ex. 1, Tr. vol. 2 at 141-42).

Following the hearing, the parties filed post-hearing briefs (CMS Br. and P. Br., respectively) and post-hearing reply briefs (CMS Reply and P. Reply, respectively).3

II.    Discussion

**Applicable Law****Statutory and Regulatory Medicare Program Enforcement**The statutory and regulatory requirements for participation of a SNF in Medicare are at section 1819 of the Social Security Act (Act) and 42 C.F.R. pt. 483.  Section 1819(h)(2) of the Act authorizes the Secretary (the Secretary) of Health and Human Services (HHS)

**Page 4**

to impose enforcement remedies against a SNF for failure to comply substantially with the federal participation requirements established by sections 1819(b), (c), and (d) of the Act.4 The Act requires that the Secretary terminate the Medicare participation of any SNF that does not return to substantial compliance with participation requirements within six months of being found not to be in substantial compliance.  Act § 1819(h)(2)(C).  The Act also requires that the Secretary deny payment of Medicare benefits for any beneficiary admitted to a SNF if the SNF fails to return to substantial compliance with program participation requirements within three months of being found not to be in substantial compliance – commonly referred to as the mandatory or statutory denial of payments for new admissions (DPNA).  Act § 1819(h)(2)(D).  The Act grants the Secretary discretionary authority to terminate a noncompliant SNF’s participation in Medicare, even if there has been less than six months of noncompliance.  The Act also grants the Secretary authority to impose other enforcement remedies, including a discretionary DPNA, civil money penalties (CMP), appointment of temporary management, and a directed plan of correction.  Act § 1819(h)(2)(B).

The Secretary has delegated to CMS and the states the authority to impose remedies against a SNF or NF that is not in substantial compliance with federal participation requirements.  42 C.F.R. §§ 488.400, 488.402(b). “*Substantial compliance*means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm.” 42 C.F.R. § 488.301 (emphasis in original).  A deficiency is a violation of a participation requirement established by sections 1819(b), (c), and (d) of the Act or the Secretary’s regulations at 42 C.F.R. pt. 483, subpt. B.  42 C.F.R. § 488.301.  The term “noncompliance” refers to any deficiency (statutory or regulatory violation) that causes a facility not to be in substantial compliance; that is, a deficiency that poses a risk for more than minimal harm.  42 C.F.R. § 488.301.  Therefore, even if a facility violates a statutory or regulatory requirement, CMS may not impose enforcement remedies if the deficiency does not pose a risk for more than minimal harm.

State survey agencies survey facilities that participate in Medicare on behalf of CMS to determine whether the facilities are complying with federal participation requirements.  42 C.F.R. §§ 488.10‐.28, 488.300-.335.  The regulations specify the enforcement

**Page 5**

remedies that CMS may impose if a facility is not in substantial compliance with Medicare requirements.  42 C.F.R. § 488.406.

CMS is authorized to impose a CMP against a facility not in substantial compliance with program participation requirements.  CMS is authorized to impose a CMP on a per day or per instance basis.  In this case, CMS proposed a PICMP and a per day CMP.  When the survey was conducted between August 19 and 28, 2019, and the initial determination was issued on December 9, 2019, CMS was authorized to impose a per day CMP in the lower range of CMPs of $107 to $6,418 per day for noncompliance that did not pose immediate jeopardy and in the upper range of CMPs of $6,524 to $21,393 for noncompliance that posed immediate jeopardy.  CMS was authorized to impose a PICMP of $2,140 to $21,393.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2019).

The Act and regulations make a hearing before an ALJ available to a SNF against which CMS has determined to impose an enforcement remedy.  Act §§ 1128A(c)(2), 1866(h); 42 C.F.R. §§ 488.408(g), 498.3(b)(13).  A facility has a right to appeal a “certification of noncompliance leading to an enforcement remedy.” 42 C.F.R. §§ 488.408(g)(1); 488.330(e), 498.3(b)(13).  However, the choice of remedies, or the factors CMS considered when choosing remedies, are not subject to review.  42 C.F.R. § 488.408(g)(2).  A facility may only challenge the scope and severity level of noncompliance determined by CMS if a successful challenge would affect the range of the CMP that may be imposed or impact the facility’s authority to conduct a nurse aide training and competency evaluation program.  42 C.F.R. § 498.3(b)(14), (d)(10)(i).  The CMS determination as to the level of noncompliance, including the finding of immediate jeopardy, “must be upheld unless it is clearly erroneous.” 42 C.F.R. § 498.60(c)(2); *Woodstock Care Ctr.*, DAB No. 1726 at 9, 39 (2000), *aff’d*, *Woodstock Care Ctr. v. Thompson*, 363 F.3d 583 (6th Cir. 2003).  The Board has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination.  *See, e.g*., *Ridge Terrace*, DAB No. 1834 (2002); *Koester Pavilion*, DAB No. 1750 (2000). ALJ review of a CMP is subject to 42 C.F.R. § 488.438(e).

Petitioner was notified in this case that was ineligible to conduct a NATCEP for two years.  CMS Ex. 2 at 5.  Ineligibility to conduct a NATCEP is not an enforcement remedy that the state agency and CMS have the authority or discretion to impose.  42 C.F.R. § 488.406 (list of remedies CMS and the state agency are authorized to impose in addition to termination).  Pursuant to sections 1819(b)(5) and 1919(b)(5) of the Act, SNFs and NFs may only use nurse aides who have completed a training and competency evaluation program.  Pursuant to sections 1819(f)(2) and 1919(f)(2) of the Act, the Secretary was tasked to develop requirements for approval of NATCEPs and the process for review of those programs.  Sections 1819(e) and 1919(e) of the Act impose upon the states the requirement to specify what NATCEPs they will approve that meet the

**Page 6**

requirements that the Secretary established and a process for reviewing and re-approving those programs using criteria the Secretary set.  The Secretary promulgated regulations at 42 C.F.R. pt. 483, subpt. D.  Pursuant to 42 C.F.R. § 483.151(b)(2) and (f), a state may not approve and must withdraw any prior approval of a NATCEP offered by a SNF or NF that has been:  (1) subject to an extended or partial extended survey under sections 1819(g)(2)(B)(i) or 1919(g)(2)(B)(i) of the Act; (2) assessed a CMP of not less than $10,697 (45 C.F.R. § 102.3 (Table)) (2019); or (3) subject to termination of its participation agreement, a DPNA, or the appointment of temporary management.  Extended and partial extended surveys are triggered by a finding of “substandard quality of care” during a standard or abbreviated standard survey and involve evaluating additional participation requirements. “Substandard quality of care” is identified by the situation where surveyors identify one or more deficiencies related to participation requirements established by 42 C.F.R. §§ 483.10, 483.12, 483.24, 483.25, 483.40, 483.45, 483.70 or 483.80, which are found to constitute either immediate jeopardy, a pattern of or widespread actual harm that does not amount to immediate jeopardy, or a widespread potential for more than minimal harm that does not amount to immediate jeopardy and there is no actual harm.  42 C.F.R. § 488.301.  The amount of the CMP imposed in this case triggers Petitioner’s ineligibility to be approved to conduct a NATCEP.  Additionally, the noncompliance cited based on the violations of 42 C.F.R. § 483.45(c) at the level of immediate jeopardy constitutes substandard quality of care which also triggers the ineligibility to conduct a NATCEP in this case.

**Burden of Proof, Burden of Production, and Quantum of Evidence**The hearing before an ALJ is a de novo proceeding, that is, “a fresh look by a neutral decision-maker at the legal and factual basis for the deficiency findings underlying the remedies.” *Life Care Ctr. of Bardstown*, DAB No. 2479 at 33 (2012) (citation omitted).

The allocation of the burden of proof and the quantum of evidence required to meet the burden is not addressed by regulations applicable in this case.5 Rather, the Board has long

**Page 7**

held that the petitioner, i.e., the nongovernmental party affected by CMS action imposing an enforcement remedy, bears the ultimate burden of persuasion to show by a preponderance of the evidence that it was in substantial compliance with participation requirements or any affirmative defense.  *Batavia Nursing & Convalescent Inn*, DAB No. 1911 (2004); *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904 (2004), *aff’d*, *Batavia Nursing & Convalescent Ctr. v. Thompson*, 129 F. App’x 181 (6th Cir. 2005); *Emerald Oaks*, DAB No. 1800 (2001); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998); *Hillman Rehab. Ctr.*, DAB No. 1611 (1997) (remand to ALJ), DAB No. 1663 (1998) (after remand), *aff’d*, *Hillman Rehab. Ctr. v. United States*, No. 98-3789 (GEB), 1999 WL 34813783 (D.N.J. May 13, 1999).  The Board has indicated that CMS has the initial burden of production to make a prima facie showing of noncompliance, which is determined without consideration or weighing of Petitioner’s evidence.  If CMS makes a prima facie showing, then the facility bears the burden to show, by a preponderance of the evidence on the record as a whole, that it was in substantial compliance or had an affirmative defense.  *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7-8, 15 (2007).  The Board has not clearly defined the quantum of evidence CMS needs to present to meet its burden of making a prima facie showing.  The Board has stated that CMS must come forward with “evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish aprima facie case of noncompliance with a regulatory requirement.” *Id.*; *Batavia Nursing & Convalescent Ctr.*, DAB No. 1904. “Prima facie” means generally that the evidence is “[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted.” *Black’s Law Dictionary*1228 (8th ed. 2004).  One might conclude that if the preponderance of the evidence is required in these proceedings, that standard would also apply to the requirement for CMS to make a prima facie showing, i.e., CMS should be required to present evidence sufficient to establish a fact as more likely true.  However, the Board has never specifically ruled that the CMS prima facie case must be supported by preponderant evidence, or what happens if it is not, including whether Petitioner has the burden of persuasion even if CMS failed to make a prima facie showing on each element

**Page 8**

of its case.  It is also unclear from prior Board decisions whether CMS can make a prima facie showing with mere allegations or a scintilla of evidence.  The Board has indicated that CMS may make a prima facies showing of noncompliance based solely upon the factual allegations of the statement of deficiencies (SOD) that “are specific, undisputed, and not inherently unreliable.” *Evergreene*, DAB No. 2069 at 15.  In this case, I conclude CMS has made its prima facie showing by a preponderance of the evidence.

**Issues**Whether there is a basis for the imposition of an enforcement remedy; and

Whether the remedies proposed are reasonable.

**Findings of Fact, Conclusions of Law, and Analysis**My conclusions of law are set forth in bold text followed by my findings of fact and analysis.  I have carefully considered all the evidence and the arguments of both parties, though not all may be specifically discussed in this decision.  I discuss in this decision the credible evidence given the greatest weight in my decision-making.6 I also discuss any evidence that I find is not credible or worthy of weight.  The fact that evidence is not specifically discussed should not be considered sufficient to rebut the presumption that I considered all the evidence and assigned such weight or probative value to the credible evidence that I determined appropriate within my discretion as an ALJ.  There is no requirement for me to discuss the weight given every piece of evidence considered in this case, nor would it be consistent with notions of judicial economy to do so.  Charles H. Koch, Jr., *Admin. L. and Prac.* § 5:64 (3d ed. 2013).

The survey that resulted in the citations of noncompliance at issue before me was completed on August 28, 2019.  The surveyors' findings and conclusions are recorded in the SOD that was admitted as CMS Ex. 1.  The surveyors alleged in the SOD the following noncompliance:

Tag F658 – Petitioner violated 42 C.F.R. § 483.21(b)(3)(i), the regulatory violation posed a risk for more than minimal harm and amounts to noncompliance

**Page 9**

as described under Tag F658, 7 and the noncompliance posed immediate jeopardy for Petitioner’s residents that the surveyors cited at a scope and severity level of K.8 CMS Ex. 1 at 1.

Tag F756 – Petitioner violated 42 C.F.R. § 483.45(c)(1)-(2) and (4)-(5), the violation posed a risk for more than minimal harm that amounted to noncompliance under Tag F756, and the noncompliance posed immediate jeopardy for Petitioner’s residents at a scope and severity of K.  CMS Ex. 1 at 29-30.

Tag F759 – Petitioner violated 42 C.F.R. § 483.45(f)(1), the violation posed a risk for more than minimal harm that amounted to noncompliance under Tag F759,

**Page 10**

and the noncompliance posed a risk for more than minimal harm at a scope and severity of D.  CMS Ex. 1 at 44.

Tag F880 – Petitioner violated 42 C.F.R. § 483.80(a), (e), and (f), the violation posed a risk for more than minimal harm that amounted to noncompliance under Tag F880, and the noncompliance posed a risk for more than minimal harm at a scope and severity of D.  CMS Ex. 1 at 46.

The December 9, 2019 CMS initial determination does not specifically mention the noncompliance alleged under Tags F759 or F880, but specifically mentions only the immediate jeopardy Tags F658 and F756.  However, the initial determination states that a per day CMP of $110 was imposed for continued noncompliance.  The initial determination is not clear as to whether the daily CMP in the lower range was imposed based on all four citations of noncompliance cited by the surveyors or just the two immediate jeopardy Tags after the immediate jeopardy was removed.  Petitioner requested review of only Tags F658 and F756 (RFH) and the parties do not discuss Tags F759 and F880 in any briefing they have provided to me.  If CMS imposed no enforcement remedy based on Tags F759 and F880, then Petitioner had no right to request review as to those Tags for which CMS decided not to impose an enforcement remedy.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13).  However, if CMS did consider F759 and F880 as a basis for imposing the daily CMP in the lower range, those uncontested deficiencies alone would be a sufficient basis for imposing the CMP.  I conclude that the lack of clarity in the CMS notice of initial determination will not be permitted to prejudice Petitioner as CMS bears the burden to provide adequate notice of the imposition of a CMP and the factual and legal basis for doing so.  42 C.F.R. §§ 488.434, 498.20.  The CMS notice is not clear and the parties do not address Tags F759 and F880 and I decline to further address those Tags.  Because I conclude that there was noncompliance under Tags F658 and F756 that is a basis for imposing both the PICMP and the per day CMP, CMS suffers no prejudice by my declining to further consider Tags F759 and F880.

I conclude, based on the following findings of fact and analysis, that CMS made a prima facie showing that Petitioner was not in substantial compliance with participation requirements due to the following regulatory violations that posed a risk for more than minimal harm and amounted to noncompliance:

Tag F658, a violation of 42 C.F.R. § 483.21(b)(3)(i) that posed a risk for more than minimal harm to Residents 39 and 71; and

Tag F756, a violation of 42 C.F.R. § 483.45(c)(4) and (5) that posed a risk for more than minimal harm to Residents 39 and 71.

**Page 11**

Petitioner has not rebutted the CMS prima facie showing or established an affirmative defense as to the allegations of noncompliance by a preponderance of the evidence.  The proposed enforcement remedies are reasonable.

**Petitioner violated 42 C.F.R. § 483.21(b)(3)(i).
	The violation of 42 C.F.R. § 483.21(b)(3)(i) posed a risk for more than minimal harm.**Petitioner is required to ensure that “services provided or arranged . . . as outlined in the [resident’s] comprehensive care plan . . . [m]eet professional standards of quality.” 42 C.F.R. § 483.21(b)(3)(i).  The surveyors allege that Petitioner violated the regulation because Petitioner had a “multi-system failure” when multiple nurses failed to follow physician orders contrary to “professional standards of nursing clinical practice.” CMS Ex. 1 at 1.  The surveyors allege more specifically that from February 2019 to August 2019, 40 nurses disregarded physician ordered parameters for administering insulin to Residents 39, 85, 100, and 155 and 10 nurses failed to administer blood pressure medication to Residents 71, 85, and 147 according to physician ordered parameters.  CMS Ex. 1 at 2.  It is not necessary to discuss the examples of all the residents discussed by the surveyors, as the examples of Residents 39 and 71 are sufficient to show the noncompliance.  ****

**Facts**(i)  Findings Related to Resident 39

Resident 39, a female, was 61 years old when the survey occurred.  CMS Ex. 6 at 110, 130.  She was admitted to Petitioner on May 28, 2018.  CMS Ex. 6 at 112, 130.  Her Minimum Data Set (MDS) with an assessment reference date of May 30, 2019, three months prior to the end of the survey on August 28, 2019, lists active diagnoses including hypertension and diabetes mellitus that required injections of insulin every day.  CMS Ex. 6 at 113, 123-24, 126.  Resident 39’s other diagnoses on admission to Petitioner included paralytic syndrome due to stroke, end stage renal disease requiring dialysis, diabetic polyneuropathy, osteoarthritis, muscle weakness, lack of coordination, bipolar disorder, and major depressive disorder.  CMS Ex. 6 at 130.

Resident 39 had a comprehensive care plan to address her diagnosis of insulin dependent diabetes mellitus and her elevated blood glucose levels secondary to that diagnosis.  Goals of the care plan included maintaining her blood glucose within normal limits of 70 to 100 mg/dL (milligrams per deciliter), keeping her free of signs and symptoms of either high or low blood glucose levels (hyperglycemia and hypoglycemia, respectively), and avoiding development of neuropathy, visual disturbance, and abnormal kidney function (all of which she already suffered according to the evidence).  The care plan required that

**Page 12**

staff monitor Resident 39’s blood glucose level, her weight, and for any signs or symptoms related to hyperglycemia and hypoglycemia.  The care plan required that Resident 39 be provided the diet ordered and the medications ordered.  Notes on the care plan show episodes of hyperglycemia in September and December 2018 and March and June 2019.  CMS Ex. 6 at 21-23.

The evidence includes multiple physician orders for insulin for Resident 39.  Petitioner’s Medication Administration Records (MARs)9 for Resident 39 in evidence list the physician orders and contain information related to the administration of insulin and other medications.  Orders reflected in the MARs for July and August 2019, are mostly consistent with copies of physician orders in evidence as CMS Ex. 6 at 13-15, 80-82, 91-93, 95-96, 103-104, and 106-107.  Only Resident 39’s MARs for July and August 2019 have been placed in evidence by CMS.  The copies of the MAR pages in evidence reflect that they were generated from Petitioner’s electronic medical records system (SigmaCare by MatrixCare®) on August 21, 2019.  Therefore, there are no entries for the administration of medications after August 20, 2019.  CMS Ex. 6 at 1-6.  Resident 39’s MARs listing the administration of insulin are the bases for the following findings.

Resident 39’s July 2019 MAR lists a January 26, 2019 order for insulin to be dosed per a sliding scale of blood glucose readings, three times daily before meals.  The MAR lists the times for administration as 7:30 a.m., 11:30 a.m., and 5:00 p.m.  The order states that the morning dose may be omitted on dialysis days – Monday, Wednesday, and Friday.  The MAR shows that on July 7 and 23, 2019 at 7:30 a.m. Resident 45 was given insulin although no site is indicated on July 7, 2019, and no dose is indicated on July 23, 2019.  Blood glucose readings at 7:30 a.m. on July 13, 18, 27, and 28, 2019, indicate that Resident 1 should have received insulin per the sliding scale, but it is not recorded that she received insulin.  Blood glucose readings at 11:30 a.m. on July 1, 2, 5, 8, 9, 10, 11, 12, 13, 15, 18, 19, 22, 23, 26, 28, and 30, indicate Resident 39 should have received insulin per the sliding scale,

**Page 13**

but no entry shows insulin was given.10 On July 8, 2019 at 11:30 a.m. a site for administration of insulin is listed but no dose.  The MAR shows that on July 6, 2019 at 7:30 a.m. and 11:30 a.m. Resident 39 was given insulin even though at both times her blood glucose was 121 and the sliding scale only required insulin if blood glucose was above 151.  Glucose readings at 5:00 p.m. indicate Resident 39 should have received insulin per the sliding scale on July 1, 2, 3, 4, 7, 8, 9, 12, 13, 14, 15, 16, 18, 19, 21, 22, 23, 25, 26, 27, and 29, 2019, but the MAR does not show that any insulin was administered.11 CMS Ex. 6 at 59.  The notes to the MAR do not include explanations for the failure to administer doses of insulin as ordered on the dates I have listed.  CMS Ex. 6 at 65-72.  Therefore, 47 times in July 2019, Petitioner’s MAR for Resident 39 does not show she was properly administered insulin as required by this physician’s order.

Resident 39’s July 2019 MAR lists a December 1, 2018 order for six units of insulin three times per week with meals on Monday, Wednesday, and Friday.  Times listed on the MAR for administration of the insulin are 12:00 p.m. and 4:30 p.m.  The MAR lists an injection site every day in July 2019 a dose was to be administered.  The dose administered is only listed six times.  Even though the dose is not always indicated on the MAR I infer that insulin was administered based on the entry of the injection site.  Five of the six times that a dose is entered, it is entered as six units.  However, on July 22, 2019 at 12:30 p.m. the MAR indicates Resident 39 was given only two units of insulin rather than the six units as ordered.  CMS Ex. 6 at 60.  There is no note to the MAR that explains why only two units of insulin were administered.  CMS Ex. 6 at 70.  Therefore, one time in July 2019, Petitioner’s MAR for Resident 39 does not show she was properly given insulin as required by this physician’s order.

**Page 14**

The July 2019 MAR lists a December 1, 2018 order for six units of insulin three times per day on non-dialysis days – Sunday, Tuesday, Thursday, and Saturday.  The times listed for administration are 7:30 a.m., 11:30 a.m., and 4:30 p.m.  CMS Ex. 6 at 61.  A note to the MAR indicates that Resident 39 refused the dose on July 4, 2019, at 11:30 a.m. but another note shows she was out of the facility on leave on July 4, 2019 at 11:30 a.m.  CMS Ex. 6 at 66.  Whether Resident 39 refused the dose or was out of the facility, Petitioner could not administer the dose of insulin and the absence of an entry of the blood glucose and dose is consistent with no dose being administered through no fault of Petitioner’s staff.  The dose administered is not listed for most days.  The injection site is listed in every instance, except at 11:30 a.m. on July 4, 2019.  I infer that for those instances when a site is listed insulin was administered even though no dose is listed.  However, at 4:30 p.m. on July 18 and 21, 2019, the MAR shows that Resident 39 was only administered two units of insulin and not the six units required by the physician’s order.  CMS Ex. 6 at 61.  The notes for the July 2019 MAR include no explanation for why the incorrect dose of insulin was given at 4:30 p.m. on July 18 and 21, 2019.  CMS Ex. 6 at 68-70.  Therefore, two times in July 2019, Petitioner’s MAR for Resident 39 does not show she was properly given insulin as required by this physician’s order.

Resident 39’s MAR for July 2019, lists a July 30, 2019 order for insulin to be administered on a sliding scale on her dialysis days, Monday, Wednesday, and Friday at 11:30 a.m. and 4:30 p.m.  On July 31, 2019 at 11:30 a.m., Resident 39 should have received insulin per the sliding scale, but the MAR does not show that any insulin was given.  At 4:30 p.m. Resident 39 also required insulin per the sliding scale and the correct dose of insulin is listed on the MAR.  CMS Ex. 6 at 55.  Therefore, one time in July 2019, Petitioner’s MAR for Resident 39 does not show she was properly given insulin as required by this physician’s order.

The resident’s MAR lists a July 30, 2019 order for insulin on a sliding scale on Resident 39’s non-dialysis days, Sunday, Tuesday, Thursday, and Saturday at 4:30 p.m.  Under this order the only instance for possible administration of insulin was on July 30, 2019, and at that time Resident 39’s recorded blood glucose was below the lowest blood glucose that required insulin per the sliding scale order.  No error in administration of the insulin is noted.  CMS Ex. 6 at 55.12

**Page 15**

The July 2019 MAR lists a June 19, 2019 prescription for seven units of insulin to be administered daily at bedtime.  The MAR reflects administration of seven units every day in July 2019 except for July 26 when the dose of insulin is listed as “123.” The blood glucose reading is also listed as “123” and I infer the entry of “123” as the insulin dose was merely a data entry error.  CMS Ex. 6 at 57.

Resident 39’s MAR for August 2019, lists a June 19, 2019 order for seven units of insulin by injection at bedtime.  The MAR records that the insulin was administered as ordered on August 1 through 5, 2019.  CMS Ex. 6 at 3.  The August 2019 MAR shows that on August 6, 2019, a new order was issued increasing the insulin at bedtime from 7 units to 12 units of insulin.  The MAR shows that this order was fulfilled only on August 9, 2019, and not on August 6 through 8 and 10 through 20, 2019.  CMS Ex. 6 at 1.  Therefore, Petitioner’s August 2019 MAR for Resident 39 shows she did not receive either 7 or 12 units of insulin at bedtime on August 6, 2019, and no doses at bedtime on 13 other days after the order for 12 units was issued.  There were 14 total instances when Petitioner’s MAR does not show that she received insulin as required by these physician orders for insulin at bedtime.

The August 2019 MAR lists a July 30, 2019 order for insulin to be administered by injection on Monday, Wednesday, and Friday – Resident 39’s days for dialysis.  The times for administration are listed on the MAR are 11:30 a.m. and 4:30 p.m.  The number of units to be administered is specified by a sliding scale based on the resident’s blood glucose reading.  The recorded blood glucose readings on the MAR show that at 4:30 p.m. on August 2, 5, 7, 16 and 19, and 11:30 a.m. on August 16 and 19, 2019, the sliding scale required that insulin be administered.  However, the MAR does not show that insulin was administered.  CMS Ex. 6 at 1.  The notes to the August 19, 2019 MAR contain no explanation for why insulin was not administered on those dates and times per the sliding scale.  CMS Ex. 6 at 9-10.  Therefore, Petitioner’s August 2019 MAR for Resident 39 fails to show that she received insulin as ordered on seven occasions.

The August 2019 MAR lists a July 30, 2019 order for insulin to be administered by injection on Resident 39’s non-dialysis days – Saturday, Sunday, Tuesday, and Thursday.  The MAR lists times for administration of 7:30 a.m., 11:30 a.m., and 4:30 p.m.  The number of units to be administered is specified by a sliding scale based on the resident’s blood glucose reading.  The recorded blood glucose readings on the MAR show that on August 1 at 11:30 a.m., August 4 at 11:30 a.m. and 4:30 p.m., August 6 at 4:30 p.m., August 8 at 4:30 p.m., August 10 at 11:30 a.m., August 11 at 11:30 a.m., August 18 at 7:30 a.m., and August 20 at 11:30 a.m. and 4:30 p.m. the sliding scale required that Resident 39 be given doses of insulin.  However, no dose of insulin is recorded on the MAR and no explanation for why the insulin was not given on those dates and times is listed in the August

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2019 notes to the MAR.  CMS Ex. 6 at 2, 9-10.  Therefore, Petitioner’s August 2019 MAR for Resident 39 fails to show that she received insulin as ordered on 10 occasions.

Resident 39’s MAR for August 2019, lists a December 1, 2018 order for six units of insulin to be injected with meals on Monday, Wednesday, and Friday.  The MAR only lists times for this order of 12:00 p.m. and 4:30 p.m. with no time for a morning meal listed.  The MAR lists injection sites for 12:00 p.m. and 4:30 p.m. on every Monday, Wednesday, and Friday except Wednesday, August 21, 2019.  The space for entering the dose administered is blank on all dates an injection site is listed except for August 9 and 14, 2019 at 4:30 p.m. and August 16, 2019 at 12:30 p.m., which have entries showing the resident received six units of insulin.  CMS Ex. 6 at 5.  Notes to the MAR indicate that insulin was not given at 12:00 p.m. on August 21, 2019, because Resident 39’s blood glucose was too low.  CMS Ex. 6 at 10.  The order does not indicate the dose of insulin is to be held for a blood glucose reading at a certain level.  CMS Ex. 6 at 5.  Nevertheless, I accept the representation that the insulin was held due to low blood glucose absent any evidence to the contrary.  Although the amount of insulin administered is not recorded for most dates and times, I infer based on the notation of an injection site that the insulin was delivered as ordered.  CMS Ex. 6 at 10.

Resident 39’s MAR for August 2019, lists a December 1, 2018 order for six units of insulin to be administered by injection three times per day on Tuesday, Thursday, Saturday, and Sunday (non-dialysis days).  Times for administration listed on the MAR are 7:30 a.m., 11:30 a.m., and 4:30 p.m.  There is no space for listing the dose of insulin administered on any day at any time.  Blood glucose readings and sites of administration are entered on the form for 7:30 a.m., 11:30 a.m., and 4:30 p.m. for Tuesday, Thursday, Saturday, and Sunday (August 1, 3, 4, 6, 8, 10, 11, 13, 15, 17, 18, and 20, 2019), except for August 13, 2019, at 11:30 a.m. when the form is completed to show insulin was not administered.  CMS Ex. 6 at 6.  The notes for the August 2019 MAR do not contain an entry explaining why insulin was not administered on August 13 at 2019, at 11:30 a.m.  There is a note that indicates that insulin was not administered at 4:30 p.m. on August 13, 2019.  CMS Ex. 6 at 9-10.  However, the MAR shows that insulin was administered at 4:30 p.m. on August 13, 2019 in the lower abdomen.  CMS Ex. 6 at 6.  I infer a clerical error was made with the nurse incorrectly recording in the notes that insulin was held at 4:30 p.m. rather than 11:30 a.m. on August 13, 2019.  The note for August 13, 2019 at 4:30 p.m. indicates insulin was held because the resident’s blood glucose was below normal parameters.  CMS Ex. 6 at 10.  However, the order recorded in the MAR shows no lower parameter for blood glucose below which insulin was not to be administered.  CMS Ex. 6 at 6, 103.  Nevertheless, I accept the representation of the notes that there was a lower parameter of blood glucose that required holding insulin.  Therefore, Petitioner’s

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August 2019 MAR for Resident 39 shows that Resident 39 received insulin consistent with this order of her physician.

In summary, Petitioner’s MARs for Resident 39, admittedly generated from Petitioner’s electronic medical records wherein the administration of insulin is recorded by Petitioner’s staff, shows that there were 51 instances in July 2019 when the MARs show Resident 39 was not administered insulin as required by physician orders.  The MARs show there were 31 instances in August 2019.  A total of 82 times in July and August 2019, Petitioner’s MARs for Resident 39 fail to show that she received insulin when required by physician orders.

(ii)  Findings Related to Resident 71

The evidence also shows a significant number of errors in the administration of medicine for hypotension for Resident 71.

Resident 71 was 76 years old at the time of the survey.  CMS Ex. 7 at 1.  His diagnoses included multiple cardiac and circulatory system diagnoses, including atherosclerotic heart disease, cardiomyopathies, atrial fibrillation, heart failure, he had a pacemaker, hypertensive heart disease, hyperlipidemia, unstable angina, and hypertension.  He also suffered many other diagnoses including chronic obstructive pulmonary disorder, shortness of breath, giddiness and dizziness, anxiety, and depression among others.  CMS Ex. 7 at 44-110.  According to the surveyor and not disputed by Petitioner is that Resident 71’s MDS, with an assessment reference date of June 6, 2019, shows that Resident 71 was assessed as suffering from orthostatic hypotension.  CMS Ex. 1 at 19.

Resident 71’s care plan effective September 12, 2018, recognized that he was at high risk for injury related to cardiovascular complications of hypertension (high blood pressure).  The care plan states the goal for Resident 71 is to maintain blood pressure within normal limits and to comply with dietary restrictions per physician’s orders.  Interventions listed required that staff:  monitor vital signs and blood pressure as ordered by the physician, administer antihypertensive medications as prescribed by the physician; provide therapeutic diet as prescribed by the physician; encourage compliance with physician ordered treatments and dietary recommendations to control blood pressure elevation; educate the resident on symptoms of high blood pressure, such as headache, weakness, muscle cramp, tingling, palpitations, sweating, and vision disturbances; and monitor for adverse reactions of antihypertensive medications such as dizziness or orthostatic hypotension (low blood pressure associated with standing from a supine position).  In the notes section of the care plan, it is noted that Resident 71 suffered from both elevated and low blood pressure. CMS Ex. 7 at 138.  Resident 71’s fall care plan effective July 5, 2013, did not indicate that he was at risk for falls due to hypotension.  CMs Ex. 7 at 123.

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On March 12, 2019, Resident 71’s attending physician prescribed one 2.5 milligram (mg) midodrine tablet orally three times per day at 6:00 a.m., 11:00 a.m., and 4:00 p.m.  The diagnosis listed for the prescription is that the resident had a cardiac pacemaker.  The order does not state the medication is to be held if the resident’s systolic13 blood pressure is greater than 130 mm Hg (millimeters of mercury).  CMS Ex. 7 at 49.  However, Resident 71’s MAR indicates that midodrine was to be held if his systolic blood pressure was greater than 130 mm Hg.  CMS Ex. 7 at 5, 13, 22, 30, 37.  The order for one, 2.5 mg midodrine tablet given orally three times a day was renewed on April 9, 2019 and May 18, 2019.  CMS Ex. 7 at 57, 68, 79, 90, 99, 109.  None of the renewal orders state that midodrine was to be held if the resident’s systolic blood pressure was greater than 130 mm Hg.  The conflict between the MARs and the orders was not cited as a deficiency by the surveyors, who suggest in the SOD that the order to hold was included in the physician’s orders.  CMS Ex. 1 at 20.

The evidence includes Resident 71’s MARs for April through August 2019. CMS Ex. 7 at 1-41.  The surveyors allege in the SOD that Petitioner’s March 2019 MAR for Resident 71 shows that midodrine was administered outside physician ordered parameters two times.  CMS Ex. 1 at 20.  Resident 71’s records obtained by the surveyors during the August 2019 survey are in evidence marked as CMS Ex. 7.  CMS Ex. 7 includes no copy of a March 2019 MAR for Resident 71.  CMS Ex. 8 is a spreadsheet listing medication administration, but it does not indicate what medication was administered and there was no testimony at hearing that explained CMS Ex. 8.  Therefore, I do not further consider the allegations regarding errors in administering midodrine to Resident 71 in March 2019.

Petitioner’s MARs for Resident 71 from April through August 20, 2019, show that midodrine was administered 38 times in violation of physician orders because the resident’s systolic blood pressure was greater than 130 mm Hg at the time of administration – 4 times in April, 6 times in May, 8 times in June, 12 times in July, and 8 times in August.  CMS Ex. 7 at 5, 13, 22, 30, 37.  The MARs state that midodrine 2.5 mg was dispensed on the dates and at the times listed.  However, if the midodrine was held then an “*” was to be entered on the date and time.  All the entries include nurse initials or identifiers and I draw no inference based on the presence of the initials or identifiers regarding the administration of midodrine.  CMS Ex. 7 at 5, 13, 22, 30, 37.  My finding is that midodrine was not properly administer 38 times because no “*” appears on the MAR to indicate the midodrine was held on the date and at the time the recorded blood pressure was above 130 mm Hg.  I find it more likely than not that the midodrine was

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administered 38 times in error as entered on the MARs in the absence of evidence to the contrary.

(iii)  Findings Related to Applicable Standards of Quality

The regulation CMS alleges Petitioner violated requires that services provided or arranged by Petitioner as required by a resident’s care plan meet professional standards of quality.  42 C.F.R. § 483.21(b)(3)(i).  Therefore, it is necessary to determine what are the professional standards of quality against which CMS wants to measure Petitioner’s nurses’ performance.  The surveyors alleged in the SOD under Tag F658 that the medication errors amounted to services that do not meet professional standards that posed a risk for more than minimal harm and posed immediate jeopardy for Petitioner’s residents.  The surveyors allege that professional standards of nursing require administering medication according to physician orders.  CMS Ex. 1 at 1.

RN Adaci, Petitioner’s expert, testified that the professional standards incorporated by reference under Tag F658 are those set by professional organizations, licensing boards, regulating agencies, and entities like the American Diabetic Association (ADA).  Tr. vol. 2 at 147.  Petitioner did not present evidence from any of these entities that contradict that professional standards of nursing quality require administering medication according to physician orders.

Petitioner is in New Jersey.  New Jersey law14 requires that licensed nurses follow orders issued by a licensed or otherwise legally authorized physician or dentist.  CMS Ex. 1 at 2-3.  Petitioner does not deny that under New Jersey law it is a professional standard for nurses to comply with physician orders.

The Board has also looked to a facility’s resident care policies as evidence of professional standards of quality.  The Board is willing to infer or presume that a facility policy reflects a professional standard of quality absent evidence to the contrary.  *Perry County Nursing Ctr.*, DAB No. 2555 at 9 (2014).  Petitioner’s policy on medication administration issued March 20, 2015, requires that nurses that administer medication ensure that a resident receive the right dose of medication, at the right time, and via the correct route.  CMS Ex. 13 at 61, 117; Tr. vol. 1 at 39; Tr. vol. 2 at 10.

The Board has also found it appropriate to rely upon a surveyor’s testimony as to what constitutes a professional standard of nursing care when the evidence shows the surveyor had training, experience, and knowledge in the field.  *Perry County*, at 9.  Surveyor Dawn

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Stillwell, RN, testified that she participated in the recertification survey of Petitioner that concluded on August 28, 2019.  Tr. vol. 1 at 33.  She testified that regarding the noncompliance alleged under Tag F658, that the surveyors found that numerous nurses were not following physician orders contrary to professional nursing standards.  Tr. vol. 1 at 34-35, 43-45; CMS Ex. 12.  As a registered nurse, Surveyor Stillwell had sufficient expertise through training and experience to opine that following physician orders is a professional standard for nurses.

I find the preponderance of evidence shows that it is a professional standard of quality for nurses to follow physician orders.

(iv)  Findings Related to the Risk for More than Minimal Harm

CMS must show as part of its prima facie case that there is a risk for more than minimal harm due to a deficiency, i.e., a regulatory or statutory violation, to show that there is noncompliance that is a basis for the imposition of an enforcement remedy.  42 C.F.R. §§ 488.301 (deficiency is violation of a participation requirement, substantial compliance means no deficiency poses a risk for more than minimal harm, and noncompliance means that a facility is not in substantial compliance); 488.402(b) (enforcement remedies are imposed based on noncompliance); *Evergreene Nursing Care Ctr.*, DAB No. 2069 at 7-8, 15 (CMS must make a prima facie showing of noncompliance, whether CMS made a prima facie showing is determined without consideration of Petitioner’s rebuttal evidence, and may be based solely on the SOD).  The surveyors allege that there was a risk for more than minimal harm due to the citation of noncompliance under Tags F658 and F756.  However, that allegation is disputed by Petitioner.  Tr. vol. 2 at 135-36.  I find that the preponderance of the evidence shows that there was risk for more than minimal harm for Residents 39 and 71 due to the failure to deliver medications as ordered.

The surveyors allege noncompliance under Tags F658 and F756, and inherent in that allegation is that Petitioner’s regulatory violations posed a risk for more than minimal harm.  The surveyors also allege that the noncompliance posed immediate jeopardy, which reflects the determination that there was a risk for more than minimal harm.  CMS Ex. 1 at 1, 29.  Surveyor Stillwell testified that she did not observe any actual harm during the survey.  However, in her opinion the medication errors posed a risk for likely serious adverse outcomes because nurses were not following physician orders.  Tr. vol. 1 at 175, 186.

Surveyor Lisa Roccia, RN, testified that she participated in the annual survey of Petitioner that was completed on August 28, 2019, and helped write the SOD with Surveyor Stillwell.  She testified that Petitioner was cited for noncompliance under Tag F658 because, based on the surveyors’ review of resident MARs, nurses failed to administer medication in accordance with physician orders, specifically insulin and

**Page 21**

hypertension medication.  She testified that noncompliance was cited under Tag F756 because the pharmacy consultant failed to identify irregularities.  She testified that the noncompliance cited under Tags F658 and F756 was based on the same facts.  Tr. vol. 2 at 5-9, 86.  Surveyor Roccia opined that many of Petitioner’s nurses failed to follow Petitioner’s medication administration policy because they were not giving medications according to physician orders.  Tr. vol. 2 at 10.  She opined that the errors on the MARs were not a computer software problem because the evidence shows that some nurses entered information correctly while others did not.  Tr. vol. 2 at 32-33.  She testified that immediate jeopardy was cited because insulin is a high-risk medication and multiple nurses failed to follow physician orders over a long period and that posed a risk for serious injury to residents.  Tr. vol. 2 at 64-67.  Surveyor Roccia testified that it is standard of practice to record blood sugar, injection site, and the amount of insulin given so that you know the medication was administered correctly.  Tr. vol. 2 at 107-08.  She testified that she did not find that Residents 39 or 71 suffered any adverse health effects, i.e., she did not find that they suffered actual harm.  Tr. vol. 2 at 115.

Petitioner’s administrator, Pinchas Goldblatt, testified at the hearing that Resident 39 suffered no harm based on the administration of insulin and none of the four residents in the survey sample experienced hypoglycemia or hyperglycemia.  Tr. vol. 1 at 199.  Administrator Goldblatt may have been unaware that care plan notes in evidence dated March 5, 2019 and June 3, 2019, show that Resident 39 had episodes of hyperglycemia.  CMS Ex. 6 at 23.  Administrator Goldblatt does not have training as a physician or nurse or any other training of which I have been informed that qualifies him to render medical opinions and I give no weight to his opinion that Resident 39 suffered no harm.  He testified that Petitioner concedes that on July 6, 2019, Resident 39 received insulin when she should not have.  He opined Resident 39 suffered no harm due to the improper doses of insulin.  Tr. vol. 1 at 209.  However, he is not qualified as a physician, nurse, or otherwise medically qualified to render such an opinion.  He further opined that the two errors did not show a widespread risk of harm for residents.  Tr. vol. 1 at 209.  Administrator Goldblatt fails to address the fact Resident 39’s MARs reflect 82 errors related to the administration of insulin.  CMS Ex. 6 at 1-11, 55-72.  Administrator Goldblatt’s opinion that the problem with documenting insulin administration was not a widespread problem involving numerous staff and residents is not credible, absent citation to specific evidence in support of that opinion.  Petitioner’s challenge is that without documentation on the MARs, Petitioner cannot show that it was more likely than not that insulin was administered when it was necessary.

Administrator Goldblatt testified regarding the allegation related to Resident’s 71’s blood pressure medicine that the surveyors never alleged that Petitioner’s staff failed to give the medication.  Tr. vol. 1 at 205.  Administrator Goldblatt’s testimony is misleading because the allegation is that Resident 71 received medication when he should not have.  The surveyors alleged that Resident 71 was given midodrine, a medication for the control of blood pressure, outside of physician ordered parameters when he should not have

**Page 22**

received midodrine under the physician orders.  CMS Ex. 1 at 20-22.  Resident 71’s MAR shows that he received midodrine when it should have been held in April 2019 (CMS Ex. 7 at 5), May 2019 (CMS Ex. 7 at 13), June 2019 (CMS Ex. 7 at 22), July 2019 (CMS Ex. 7 at 30), and August 2019 (CMS Ex. 7 at 37).

Petitioner called Nelia Adaci, RNto testify as an expert witness at the hearing.  P. Ex. 1; Tr. vol. 2 at 138, 142.  She testified that shortly after the survey that ended on August 28, 2019, she was retained by Petitioner as a consultant.  She testified that she did a root-cause analysis related to the noncompliance cited by the surveyors.  She testified that in her opinion Petitioner was not deficient because the problem was not nurses failing to follow physician orders, rather, the problem was Petitioner’s electronic medical records.  Tr. vol. 2 at 142, 144-46.  She testified she felt it was unfair to characterized Petitioner’s nurses as failing to follow physician orders.  She testified that she did find lapses in care reflected in medical records and documentation.  However, she asserted that there was no evidence of any adverse reaction.  Tr. vol. 2 at 148-49.  RN Adaci agreed in response to my questioning that it is important to record the administration of insulin and the injection site.  Tr. vol. 2 at 182-83.  She testified in response to my question that her root cause analysis did not include interviewing staff to determine whether they committed a medication error, e.g., whether they gave insulin when not required by a physician’s order for a sliding scale or gave the wrong dose.  Tr. vol. 2 at 190.

Petitioner provided a declaration that RN Adaci executed prior to hearing setting forth her findings.  RN Adaci did not deny that the MAR of Resident 39 and the MARs of three other residents show that nursing staff failed to record the site of insulin administration and the amount of insulin administered.  P. Ex. 2 at 7-10 ¶¶ 26-27, 30, 39.  She opined that Petitioner’s nurses did not disregard physician orders and properly administered the insulin but simply failed to record evidence of administration by entering site and dose because the software was flawed.  She infers that insulin was administer by nursing staff because, had insulin not been administer, the residents would have exhibited signs and symptom of hyperglycemia.  P. Ex. 2 at 8 ¶¶ 28-29.  She asserts that had the nurses missed the doses alleged by the surveyors, the residents would have exhibited signs or symptoms of hyperglycemia at least one time.  P. Ex. 2 at 9 ¶ 37, 12 ¶ 52; Tr. vol. 2 at 201-02, 207-08, 234.  However, RN Adaci does not point to nurses notes or progress notes to support her opinion that Resident 39 did not suffer either hypoglycemia or hyperglycemia and Petitioner did not place such records in evidence for Resident 39.  RN Adaci also apparently missed care plan notes that are in evidence dated March 5, 2019 and June 3, 2019, that show that Resident 39 had episodes of hyperglycemia.  CMS Ex. 6 at 23.  The one progress note in evidence for Resident 39

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dated July 22, 2019, does not mention either hyperglycemia or hypoglycemia.15 CMS Ex. 6 at 16-18.  She concedes that on July 6, 2019, Resident 39 received doses of insulin when her blood glucose was recorded as 121 and admits that level was below the physician order to administer insulin only when her blood glucose was above 151.  She acknowledges that one dose of insulin on July 6, 2019, was two units with a blood glucose of 121 and the other dose on July 6, 2019, was four units with the same blood glucose of 121.  P. Ex. 2 at 10 ¶¶ 43-46; Tr. vol. 2 at 203-04.  RN Adaci does not address the fact that four units was a further violation of physician orders as under the sliding scale four units should only have been given if the resident’s blood glucose was above 201 (CMS Ex. 6 at 59).  RN Adaci asserts that despite the occurrence of three violations of physician ordered parameters for administering insulin to Resident 39 on July 6, 2019, the resident was at no risk for harm.  P. Ex. 2 at 10 ¶¶ 43-46; Tr. vol. 2 at 204-06.  RN Adaci did not testify that violation of physician orders when administering insulin never poses a risk for more than minimal harm.  It is surprising and not credible that an expert witness with RN Adaci’s expertise would not recognize the risk for harm to a resident due to the violation of physician orders in the administration of insulin and reflects an unacceptably cavalier attitude about compliance with physician orders as a standard of practice for nurses.  RN Adaci further opines that “[a] preponderance of evidence shows that the facility administered NovoLog Insulin in complete adherence to the Manufacturer’s Prescribing information and Standards of Practice in managing [diabetes] in Nursing Homes.”  P. Ex. 2 at 12-14 ¶¶ 50-62.  An opinion I also reject as not credible based largely upon Petitioner’s own evidence discussed hereafter.

Petitioner placed in evidence manufacturer’s prescribing information for NovoLog.  The prescribing information cautions that dosage must be individualized and any change in dose should be made cautiously under medical supervision.  P. Ex. 3 at 3, 5.  The manufacturer states hypoglycemia is the most common adverse effect of insulin therapies and “[s]evere hypoglycemia may lead to unconsciousness and or convulsions and may result in temporary or permanent impairment of brain function or death.” P. Ex. 3 at 5.  The manufacturer describes several factors that may alter the risk for hypoglycemia.  The manufacturer also cautions that insulin products, including NovoLog may cause hypokalemia, renal impairment, and hepatic impairment among other conditions, all of which are serious conditions harmful to one administered insulin.  P. Ex. 3 at 5-6.  Based on the manufacturer’s prescribing information for NovoLog, RN Adaci’s representation that incorrect dosing of insulin poses no risk for harm is not credible and must be rejected.  The manufacturer’s information certainly does not suggest that administration of two or four units of insulin when not necessary under physician orders poses no risk for harm, and RN Adaci’s opinion to the contrary appears to have been developed

**Page 24**

without full consideration of the manufacturer’s prescribing information.  The manufacturer’s information is consistent with and supports the surveyors’ conclusion that administering an unnecessary dose of insulin or failure to administer insulin as ordered poses a risk for hypoglycemia or hyperglycemia and more than minimal harm.

Petitioner also placed in evidence an article published by the ADA, which does not indicate that giving an incorrect dose of insulin poses no risk for harm to one who is provided the incorrect dose.  P. Ex. 4.  P. Ex. 5 is a position statement of the ADA addressing management of diabetes in long-term care facilities.  The ADA guidelines recognize that the existence of comorbidities and overall health of residents makes it critical to establish personalized goals and treatment of diabetes in such residents.  The ADA states “[t]he risk of hypoglycemia is the most important factor in determining glycemic goals due to the catastrophic consequence in this population.”  P. Ex. 5 at 1.  The ADA points out that the prevalence of diabetes in long-term care residents is 25 to 34 percent, which is much higher than the general population.  P. Ex. 5 at 1.  The ADA guidelines recognize that the risk for hypoglycemia are dependent on the condition of the individual resident with multiple factors that impact the risk.  Generally, the risk for hypoglycemia is higher in long-term care residents than the general population.  P. Ex. 5 at 3-5.  The ADA guidelines mention throughout that excessive reliance on sliding scale insulin is disfavored and, if used, it should be in conjunction with other glucose lowering agents.  P. Ex. 5 at 1, 4, 10.  The guidelines stress that challenges must be identified for a resident that requires diabetes management, then an individualized plan can be designed to improve diabetes management and reduce the risk of hypoglycemia, thereby improving quality of life for the resident.  Diabetes requires an interprofessional team approach.  P. Ex. 5 at 1, 10.  Inappropriate dosing or timing of insulin is one of the challenges for long-term care staff and practitioners that the guidelines indicate must be addressed.  The guidelines recognize that improper dosing of insulin poses a risk for hypoglycemia and hyperglycemia, which may cause serious harm, injury, or death.  P. Ex. 5 at 1, 3-4.  The guidelines specifically mention federal inspections, federal quality of care regulations, and the fact financial penalties may be imposed for noncompliance.  P. Ex. 5 at 10.  The guidelines do not suggest that it is acceptable for staff to not follow physician orders for sliding scale insulin by failing to give insulin when required or giving insulin when not required.  To the extent that RN Adaci’s opinion may be read to be that missing doses or unnecessary doses of insulin are acceptable under the ADA guidelines, the opinion is not supported by the guidelines and not credible.  Indeed, the ADA guidelines support the surveyors’ conclusion that there was a risk for more than minimal harm to Petitioner’s residents who were given a dose of insulin when not required or who were given an incorrect dose of insulin.

RN Adaci states in her declaration that Resident 71 suffered from orthostatic hypotension, which is low blood pressure that often results when standing from a supine position.  Resident 71 was prescribed midodrine for his hypotension because it increases blood pressure.  The midodrine was prescribed as one 2.5 mg tablet three times per day,

**Page 25**

except it was to be held if the resident’s systolic blood pressure was above 130.  RN Adaci states that Petitioner does not dispute that there were some administration errors by Petitioner’s staff.  She does not state that she identified a particular number of errors but recites the surveyors’ finding of 35 instances of failure to follow physician orders during the period March through August 2019.  P. Ex. 2 at 14-15 ¶¶ 63-68.  RN Adaci does not specifically discuss the multiple instances during the period April through August (up to the survey) when Resident 71’s MARs show that he was given midodrine when his systolic blood pressure was significantly above 130.  CMS Ex. 7 at 5, 13, 22, 30, 37.  RN Adaci opined based on her understanding of the manufacturer’s prescribing information for midodrine that it was extremely unlikely that Resident 71 was at risk for actual harm when he was administered midodrine and his systolic blood pressure was above 130.  P. Ex. 2 at 15-16 ¶¶ 70-75.  During the hearing she opined that Resident 71 was not a risk for more than minimal harm due to the administration of midodrine in violation of physician orders when his systolic blood pressure was greater than 130 because he was on a low dose of midodrine.  Tr. vol. 2 at 208-09.  She states “[t]here was no indication of any signs or symptoms that may have resembled or indicated any form of potential or actual harm to Resident # 71 in the 35 times that the drug was administered outside of the parameters.” P. Ex. 2 at 16 ¶ 73.  RN Adaci does not disclose whether she bases her opinion that there no signs or symptoms on Resident 71’s medical records or some other evidence.  Progress notes are where signs and symptoms would most likely be recorded.  However, there are no progress notes for Resident 71 in evidence and notes on the resident’s MARs are minimal.  CMS Ex. 7.  RN Adaci opines that there was no harm or likelihood of harm to Resident 71 and no likelihood of serious injury, harm, impairment, or death, i.e., immediate jeopardy.  P. Ex. 2 at 16-17 ¶¶ 76-79.  She goes on to state that Resident 71’s “entire medical record supports the conclusion that he was medically stable even after the [erroneous] administration” citing CMS Ex. 7 as the basis for this opinion.  However, CMS Ex. 7 does not include significant portions of Resident 71’s medical records, chiefly progress notes by physicians, nurses, and other medical professionals who would recognize the manifestation of signs and symptoms related to giving midodrine when it should not have been given.  CMS Ex. 7, which includes physician order sheets, pages of MARS, and care plan pages, simply does not provide RN Adaci a sufficient basis for her opinion that Resident 71 suffered no harm due to improperly being given midodrine outside physician parameters.  The fact that she failed to recognize that she did not have in CMS Ex. 7 the evidence necessary to support her opinion casts doubt upon all her opinions expressed in this case.  It is unfortunate that RN Adaci expressed her opinions without insisting that Petitioner provide and place in evidence the complete record for Resident 71, which may or may not have shown that he suffered increased hypotension or other symptoms due to the improper administration of midodrine.

Petitioner did place in evidence information regarding midodrine from the website Drugs.com.  The information includes an alert that indicates “midodrine can cause marked elevation of supine blood pressure.” P. Ex. 6 at 6.  The alert is consistent with the surveyors’ conclusion that administering midodrine contrary to physician orders poses a

**Page 26**

risk for more than minimal harm.  The information further specifies that supine and sitting blood pressure should be monitored.  P. Ex. 6 at 7.  Petitioner also placed in evidence manufacturer’s information that includes a warning that midodrine can cause marked elevation of supine blood pressure.  P. Ex. 7 at 1, 3-4.  The manufacturer’s information indicates that supine and standing blood pressure should be monitored regularly to determine if supine blood pressure increases excessively.  P. Ex. 7 at 8.  The manufacturer’s information is consistent with the surveyors’ conclusion that administering midodrine when unnecessary poses a risk for more than minimal harm.

RN Adaci’s opinions that Residents 39 and 71 were not at risk for more than minimal harm are not as weighty as the evidence Petitioner presented showing that improper dosing of insulin and midodrine poses a risk for more than minimal harm.  I find that there was a risk for more than minimal harm to both residents.

(v.)  Findings Related to Petitioner’s Electronic Medical Records

Pinchas Goldblatt, Petitioner’s administrator during the August 2019 survey testified at length about SigmaCare, the electronic medical records program Petitioner was using during the survey.  He had been Petitioner’s administrator for about four years at the time of the survey.  He testified that the decision to use SigmaCare was made before he became the administrator, and it was in use for about a year and a half before he became administrator.  Tr. vol. 1 at 193-95.  I infer that Petitioner had used SigmaCare for more than five years before the survey.

Administrator Goldblatt testified that it was thought that SigmaCare was a top-of-the-line product when it was purchased, but that did not prove to be the case.  He explained that one problem was that staff would weigh a resident and forget to deduct the weight of the wheelchair.  Petitioner wanted SigmaCare to be modified prevent a weight entry if the difference in weight was beyond a certain amount each day or, at least, to alert staff to the possibility that the wheelchair weight was included.  SigmaCare’s response was that Petitioner’s staff needed to be more careful.  Administrator Goldblatt testified that SigmaCare was not helpful with Petitioner’s complaints.  After the survey, Petitioner went to a new electronic medical records program.  He testified there were other problems with SigmaCare.  Tr. vol. 1 at 193-97.  He testified that nurses were sometimes unable to enter insulin injection site and dose of insulin administered in SigmaCare.  He testified that nurses were unable to enter the information as the option of site and dose was not on the medication pass screen.  Tr. vol. 1 at 200-01.  This testimony lacks credibility because Resident 39’s MARs for July and August 2019, clearly show that many times site and does information was recorded by Petitioner’s nurses.  CMS Ex. 6 at 1, 59.  Administrator Goldblatt testified that SigmaCare offered no solution.  Tr. vol. 1 at 204.  He opined Petitioner’s nurses were doing the best they could using the SigmaCare system.  Tr. vol. 1 at 207.  He testified that prior to the survey, staff had been

**Page 27**

trained on medication administration and if they could not follow a physician order for medications, they were to inform a manager and/or call the physician.  Tr. vol. 1 at 207-08.  He did not opine that all nurses followed their training.

RN Adaci asserts that the surveyors “raised no issue on the propriety or impropriety of administration” of insulin.  P. Ex. 2 at 9 ¶ 35.  She asserts that the surveyors cited Petitioner because nurses failed to document dose and site of administration.  She subsequently concedes that the surveyors allege, at least in part, that residents did not receive insulin within physician ordered parameters.  P. Ex. 2 at 9 ¶ 37.  Her opinion is that nurses did not disregard physician orders, rather, Petitioner’s had a software problem.  P. Ex. 2 at 10 ¶ 40.  RN Adaci’s opinion that Petitioner had a software problem is certainly consistent with the evidence of record.  However, her opinion that physician orders were not disregarded or at least violated, is not supported by the weighty evidence in this case.

RN Adaci testified she believed Petitioner’s management was aware of a problem with the software and was trying to have the software company fix the problem.  She did not see any documentation of communication with the software company but got her information from the administrator and owner.  Tr. vol. 2 at 183-85.  RN Adaci did not express any concern that, although Petitioner had been using SigmaCare for five years prior to the survey, Petitioner had developed no alternate solutions to ensure residents were correctly receiving medications and that the administration of medications was documented so that nurses and other staff, physicians, and the consultant pharmacist could verify that medications were administered as ordered.

**Analysis**Petitioner must ensure that “[t]he services provided or arranged by the facility, as outlined by the comprehensive care plan . . . [m]eet professional standards of quality.” 42 C.F.R. § 483.23(b)(3)(i).  There is no regulatory definition of “professional standards of quality.” However, under Tag F658 in the SOM CMS explains its view that professional standards of quality means that care and services are provided in accordance with accepted standards of clinical practice.  CMS Ex. 18 at 1.  I have found that accepted standards of clinical practice require that nurses follow physician orders for the administration of medication.

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The Board has previously recognized that a nurse’s failure to carry out a physician’s order may constitute a failure to meet professional standards of quality.16*Life Care Ctr. of Tullahoma*, DAB No. 2304 at 31 (2010) (citing *Georgian Court Nursing Ctr*, DAB No. 1866 at 8 (2003); *Emerald Oaks*, DAB No. 1800 at 37 (2001)), *aff’d*, *Life Care Ctr. Tullahoma v. Sec’y of U.S. Dept. of Health & Human Servs.*, 453 F. App’x 610 (6th Cir. 2011).

Petitioner’s MARs for Resident 39 for July and August 2019, fail to show that the resident was correctly administered insulin in accordance with physician orders a total of 82 times.  Petitioner’s MARs for Resident 71 for April through August 20, 2019, fail to show that the resident was correctly administered midodrine per physician orders 38 times.  Failure to follow physician orders is a violation of the regulatory requirement for professional standards of quality in the delivery of care.  I have also found that the failure to administer medications to Resident 39 and 71 posed a risk for more than minimal harm to those residents.  I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.21(b)(3)(i) that posed a risk for minimal harm and amounts to noncompliance under Tag F658.  Therefore, Petitioner bears the burden to show by a preponderance of the evidence that it was in substantial compliance with the participation requirement to provide care and services meeting professional standards of quality, i.e., that there was no violation of 42 C.F.R. § 483.21(b)(3)(i) that posed a risk for more than minimal harm to any resident.  Petitioner does not meet its burden.

Petitioner argues CMS failed to make a prima facie case of noncompliance, pointing to perceived errors and possible inconsistencies among the SOD, surveyor prepared documents, and the surveyors’ testimony.  P. Br. at 2-6.  Petitioner’s argument is without merit.  The regulations are clear that any inadequacies in survey performance do not relieve a facility from meeting all the requirements of program participation or invalidate adequately documented deficiencies.  42 C.F.R. § 488.318(b).  The Board made clear in *Avon Nursing Home*, DAB No. 2830 (2017), that the surveyor’s and CMS’s view of the evidence are irrelevant to an ALJ’s de novo review, except to the extent that CMS relies upon unreliable evidence as supporting its findings and conclusions of noncompliance.  The Board explained:

An ALJ decides the noncompliance issue de novo – that is, without deference to CMS’s or the state survey agency’s factual findings or legal conclusion and based on her own

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evaluation of the credibility of the submitted evidence.  *N.C. State Veterans Nursing Home, Salisbury*, DAB No. 2256, at 24 (2009).  Because the ALJ reviews CMS’s noncompliance determination de novo, an allegation that the state survey agency used improper methods or personnel to make its findings and conclusions is irrelevant, except to the extent that the state agency’s survey practices undermine the credibility of evidence that CMS identifies as supporting the noncompliance determination.

DAB No. 2830 at 12 (2017).  The Board further stated that “the ultimate issue before an ALJ is . . .‘whether the *evidence*as it is *developed before the ALJ*supports’ CMS’s independent ‘finding of noncompliance’ under the relevant participation requirements.”  *Avon*, DAB No. 2830 at 11 (citing *Sunshine Haven Lordsburg*, DAB No. 2456 at 21 (2012), *aff’d in part and transferred*,*Sunshine Haven Lordsburg v. U.S. Dept. of Health & Human Servs.*, 742 F.3d 1239 (10th Cir. 2014)) (emphasis in original).  I do not rely upon the surveyors’ allegations in the SOD or their testimony in finding and concluding that Petitioner was not in substantial compliance.  The SOD provided Petitioner notice of the allegations of noncompliance, and it is considered solely for that purpose in deciding this case.  My detailed de novo review is reflected in my findings of fact and those findings are based primarily upon the documentary evidence.  Inconsistences in the surveyors’ testimony or among their testimony, the SOD and their working documents do not adversely affect the credibility or the weight of the documentary evidence, most of which comes from Petitioner’s records for Residents 39 and 71.  In this case, the most important purpose of the surveyors testimony is explaining why they cited the noncompliance, i.e., the alleged regulatory violations and the risk for more than minimal harm, and their testimony is not relied upon to establish the existence of the noncompliance as that is determined based on the documentary evidence.  I do not rely upon the surveyors review of the evidence or their summaries of such things as how many nurses failed to follow physician orders or the number of occurrences.  The fact that numerous nurses failed to follow physician ordered parameters for the administration of insulin and midodrine is reflected by the entries or the absence of entries on the MARs for Residents 39 and 71 obtained by the surveyors during the survey from the medical records for each resident maintained by Petitioner.  My findings that numerous omissions of information from the MARs show medication was not administered as ordered is my finding and not dependent upon the opinions or findings of the surveyors.  The allegations of the surveyors in the SOD may be sufficient to make the CMS prima facie showing, but the surveyor allegations in the SOD are not accepted as sufficient standing alone to make the prima facie showing in this case.  The documentary evidence in CMS Exs. 6 and 7, particularly the MARs and physician orders, establish the CMS prima facie case.

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Petitioner’s attempts to make a convincing argument that the omissions from the MARs for Residents 39 and 71 are simple data entry errors due to difficulties Petitioner had with SigmaCare.  P. Br. at 5-6; P. Reply at 4, 6-7.  Petitioner argues that “nurses properly administered the drug [insulin] but did not enter the site/location of injection in the computer.” P. Br. at 12.  However, the argument is not convincing because Petitioner presented insufficient credible evidence to show it was more likely than not that Residents 39 and 71 were properly administered insulin and midodrine when Petitioner’s records show that there were errors in administration.  Petitioner presented no documents from either residents’ medical record such as progress notes or other evidence showing proper administration; Petitioner points to no evidence offered by CMS from Petitioner’s records that tends to show proper administration; Petitioner offers no testimony of staff that they administered the medications correctly when that is not reflected on the MAR; and neither RN Adaci17 nor Administrator Goldblatt testified that they had any knowledge that medication was administered correctly when the resident’s MARs shows it was not.  Petitioner’s position is made even more incredible by the fact that based on Administrator Goldblatt’s testimony Petitioner was using SigmaCare for five years before the survey.  Administrator Goldblatt’s testimony suggests that Petitioner had problems with SigmaCare throughout the time it was in use at Petitioner.  However, during the period prior to the survey, Petitioner had not managed to ensure that the administration of medications was properly documented either through SigmaCare or by some alternative method such as recording medication administration on paper or using some other automated system.  Petitioner has a duty under 42 C.F.R. § 483.70(i)(1)(i)-(iv) to maintain complete, accurate, accessible, and organized medical records for each resident.  Although not cited as a deficiency by the surveyors, Petitioner’s electronic medical records clearly did not meet the participation requirement for maintaining medical records for Residents 39 and 71.  As a result, Petitioner cannot show by a preponderance of the evidence that Resident 39 was properly administered insulin and Resident 71 was properly administered midodrine, when the MARs fail to show that they were.

**Petitioner violated 42 C.F.R. § 483.45(c)(4)-(5) as alleged under Tag F756.
	The violation of 42 C.F.R. § 483.45(c)(4)-(5) posed a risk for more than minimal harm.****Page 31**

**Findings of Fact**The findings of fact under Conclusions of Law 1 and 2 apply to this alleged noncompliance.

**Analysis**The SOD notified Petitioner that the surveyors concluded Petitioner violated 42 C.F.R. § 483.45(c)(1)-(2) and (4)-(5).  CMS Ex. 1 at 29-30.  Pursuant to 42 C.F.R. § 483.45(c)(1) Petitioner must ensure that a licensed pharmacist reviews each resident’s drug regime monthly.  Pursuant to 42 C.F.R. § 483.45(c)(2), the medication regimen review must include review of the residents’ medical record.  The evidence shows and there is no dispute that Petitioner had a contract pharmacy company, Pharma-Care, Inc., that provided a pharmacist who did the monthly reviews required by the regulation, including review of residents’ medical records.  CMS Exs. 9, 13 at 53-59, 14; Tr. vol. 1 at 37, 197-99, 216.

Pursuant to 42 C.F.R. § 483.45(c)(4) the reviewing pharmacist must report any irregularities to the resident’s attending physician, Petitioner’s medical director, and Petitioner’s director of nursing, and the report of irregularities must be acted upon.  The allegation of the SOD is that Petitioner’s contract pharmacist missed the errors and omissions in Resident 39’s and Resident 71’s MARs as well as errors in the records of other residents which need not be considered as the noncompliance is sufficiently shown by the examples of Residents 39 and 71.  CMS Ex. 1 at 30-36.  This allegation is in issue and requires resolution.  Pursuant to 42 C.F.R. § 483.45(c)(5), Petitioner is required to develop and maintain policies and procedures for the monthly drug regimen review.  It is not alleged that Petitioner did not have the required policy and procedures, but that Petitioner failed to maintain the policies and procedures, i.e., Petitioner failed to ensure its policy and procedures were followed as evidenced by the fact the contract pharmacist failed to identify the errors and omission in the MARs of Residents 39 and 71.  CMS Ex. 1 at 30-36.  Therefore, this allegation is also at issue and requires resolution.

The issues are whether Petitioner violated the requirements of 42 C.F.R. § 483.45(c)(4) and (5) and, if a violation occurred, whether the violation posed a risk for more than minimal harm.  I conclude that Petitioner violated 42 C.F.R. § 483.45(c)(4) and (5), and there was a risk for more than minimal harm which substantiates the noncompliance alleged under Tag F756.

Surveyor Stillwell testified that noncompliance was cited under Tag F756 because Petitioner’s consulting pharmacist failed to identify the medication administration errors the surveyors found and failed to report the errors to Petitioner’s administrator and director of nursing.  She explained that both citations of noncompliance involve the same residents and the same facts regarding the medication errors.  Tr. vol. 1 at 36-37.  She

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testified that immediate jeopardy was also cited for Tag F756 because the pharmacist consultant missed the whole problem.  Tr. vol. 1 at 116.  Surveyor Roccia testified that the pharmacy consultant failed to identify that Resident 39 was not given insulin as ordered.  Tr. vol. 2 at 27, 63.  Surveyor Roccia testified that the pharmacy consultant failed to identify that Resident 71 given medication for hypotension contrary to physician order.  Tr. vol. 2 at 48, 63.

Administrator Goldblatt testified that Petitioner’s consultant pharmacy was Pharma-Care.  Pharma-Care was supposed to audit every month and alert Petitioner if standards of care were not being followed.  A Pharma-Care representative came to Petitioner to do the monthly audit.  The audit should have included review of residents’ MARs.  He testified that the pharmacy consultant never informed him of any problem with staff entering data on MARs.  Tr. vol. 1 at 197-98, 216.  He admitted that the pharmacy consultant identified no errors in the administration of insulin or hypertension medications according physician orders.  Tr. vol. 1 at 219.

I have found by a preponderance of the evidence that Petitioner’s MARs for Resident 39, admittedly generated from Petitioner’s electronic medical records wherein the administration of insulin is recorded by Petitioner’s staff shows that there were 51 instances in July 2019 when the MARs show Resident 39 was not administered insulin per physician orders.  The MARs show there were 31 instances in August 2019.  A total of 82 times in July and August 2019, Petitioner’s MARs for Resident 39 fail to show that she received insulin when required by physician orders.  CMS Ex. 6 at 1-3, 5-6, 9-10, 55, 59-61, 65-72.

I have found by a preponderance of the evidence that Petitioner’s MARs for Resident 71 from April through August 20, 2019, show that midodrine was administered 38 times in violation of physician orders because the resident’s systolic blood pressure was greater than 130 mm Hg at the time of administration – 4 times in April, 6 times in May, 8 times in June, 12 times in July, and 8 times in August.  CMS Ex. 7 at 5, 13, 22, 30, 37.

Pharma-Care consultant pharmacist reports are in evidence in CMS Exs. 9 at 1-47 (June, July, 2019) and 14 (March, April, May, June, 2019), CMS Ex. 6 at 54 (Resident 39), and CMS Ex. 7 at 42-43 (Resident 71).  None of the errors I have found in the MARs for Resident 39 and Resident 71 generated from Petitioner’s electronic medical records are reflected in the consultant pharmacist’s reports.

RN Adaci testified regarding Tag F756 that she concluded that CMS Exs. 9 and 14 show that the pharmacy consultant did her due diligence when performing the monthly reviews.  Tr. 149-151.  CMS Exs. 9 and 14 show that the consultant pharmacist completed documents showing a detailed review of records.  However, it is difficult to reconcile the level of detail reflected with the fact the pharmacist missed errors reflected by the MARs in evidence.  Possibly the pharmacy consultant never reviewed MARs such

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as those in evidence that reflect the errors I have found.  However, one must question what the consultant did review.  The consultant was not called to testify by Petitioner and what the consultant reviewed cannot be resolved based on the evidence in the record.  RN Adaci states that Petitioner’s pharmacy consultant admitted to “missing a few errors” related to Resident 71, but she opines that Resident 71 was not at any risk for harm due to the pharmacy consultant’s failures and there was no immediate jeopardy.  P. Ex. 2 at 21 ¶ 100.  RN Adaci agreed in response to my questions that the pharmacy consultant did not report the errors in the administration of insulin to Resident 39 on July 6, 2019.  Tr. vol. 2 at 231-32.  RN Adaci admitted that she did not know what reports the pharmacy consultant considered.  Tr. 232.  I give little weight to RN Adaci’s opinions that there was no risk for harm due to the errors in following physician orders reflected in the residents’ MARs.  RN Adaci overlooked that there was evidence in Petitioner’s records that Resident 39 did suffer episodes of hyperglycemia.  CMS Ex. 6 at 23.  She testified in response to my question that her root cause analysis did not include interviewing staff to determine whether they committed medication errors, e.g., whether they gave insulin when not required by a physician’s order for a sliding scale or gave the wrong dose.  Tr. vol. 2 at 190.  RN Adaci did not reconcile her opinion that there was no risk for harm from improper administration of insulin or midodrine with manufacturer’s information and other materials placed in evidence by Petitioner that show that improper administration of both poses a risk for serious harm and, possibly, death.

I conclude that Petitioner violated 42 C.F.R. § 483.45(c)(4) and (5).  The regulatory violation posed a risk for more than minimal harm.  Accordingly, I conclude that Petitioner was not in substantial compliance with the participation requirement established by 42 C.F.R. § 483.45(c)(4) and (5).

**The declaration of immediate jeopardy was not clearly erroneous.**There was a declaration of immediate jeopardy based on the noncompliance cited under Tags F658 (42 C.F.R. § 483.21(b)) and F756 (42 C.F.R. § 483.45(c)).  CMS Ex. 1 at 1-2, 29-31.  CMS imposed a PICMP of $23,393 for one day of immediate jeopardy on August 23, 2019, based on the noncompliance under Tags F658 and F756.  CMS Ex. 2 at 1-2.  Petitioner argues there was no immediate jeopardy.  P. Br. at 17-18, 20-23; P. Reply at 6.

The threshold question is whether I have authority to review the declaration of immediate jeopardy.  CMS determined to impose a PICMP based on the declaration of immediate jeopardy for Tags F658 and F756.  The Board as previously determined that an ALJ has no authority to review the declaration of immediate jeopardy under 42 C.F.R. § 498.3(b)(14) and (d)(10)(i)-(ii), when CMS imposes a PICMP for the immediate jeopardy noncompliance.  *NMS Healthcare of Hagerstown*, DAB No. 2603 at 6-7 (2014); *Evergreen Commons*, DAB No. 2175 (2008).  However, in this case the declaration of immediate jeopardy for the violation of 42 C.F.R. § 483.45(c)(4)-(5) constituted substandard quality of care that also triggered Petitioner’s ineligibility to be approved to

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conduct a NATCEP.  Therefore, the level of noncompliance, i.e., immediate jeopardy, is subject to review pursuant to 42 C.F.R. § 498.3(b)(14)(ii).

Petitioner bears a heavy burden under the regulations when challenging a declaration of immediate jeopardy.  Unlike the issue of whether there is noncompliance, the Secretary has by regulation imposed the burden of persuasion on Petitioner to show that the declaration of immediate jeopardy was in error not by a preponderance of the evidence, but by a showing that the declaration was clearly erroneous.  The CMS determination of immediate jeopardy must be upheld unless Petitioner shows the declaration of immediate jeopardy to be clearly erroneous.  42 C.F.R. § 498.60(c)(2).  CMS’s determination of immediate jeopardy is presumed to be correct, and Petitioner has a heavy burden to demonstrate clear error in that determination.  *Yakima Valley Sch.*, DAB No. 2422 at 8-9 (2011); *Cal Turner Extended Care Pavilion*, DAB No. 2384 at 14 (2011); *Brian Ctr. Health & Rehab./Goldsboro*,DAB No. 2336 at 9 (2010) (citing *Barbourville Nursing Home*, DAB No. 1962 at 11 (2005), *aff’d*,*Barbourville Nursing Home v. U.S. Dep’t of Health & Human Servs.*, 174 F. App’x 932 (6th Cir. 2006)); *Maysville Nursing & Rehab. Facility*, DAB No. 2317 at 11 (2010); *Liberty Commons Nursing & Rehab Ctr. – Johnston*, DAB No. 2031 at 18-19 (2006), *aff’d*,*Liberty Commons Nursing & Rehab Ctr. – Johnson v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007). “Once CMS presents evidence supporting a finding of noncompliance, CMS does not need to offer evidence to support its determination that the noncompliance constitutes immediate jeopardy, rather, the burden is on the facility to show that that determination is clearly erroneous.” *Cal Turner*, DAB No. 2384 at 14-15 (citing *Liberty Commons*, 241 F. App’x 76, at 80-81).

“*Immediate jeopardy*” under the regulations refers to “a situation in which 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, 489.3 (emphasis in original).  In the context of survey, certification, and enforcement related to SNFs and NFs under the regulations, a conclusion by the state agency and CMS that noncompliance with program participation requirements poses immediate jeopardy to the facility residents, triggers specific regulatory provisions that require enhanced enforcement remedies, including authority for CMS to impose a larger CMP than may be imposed when there is no declaration of immediate jeopardy.  42 C.F.R. §§ 488.408(e), 488.438(a)(1)(i), (c), and (d).  The regulations also require termination of the facility’s provider agreement on an expedited basis or the removal of the immediate jeopardy through appointment of temporary management.  42 C.F.R. §§ 488.410, 488.440(g), 488.456, 489.53(d)(2)(ii).

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Many appellate panels of the Board have addressed “immediate jeopardy.”18 In *Miss. Care Ctr. of Greenville*, the Board commented:

CMS’s determination that a deficiency constitutes immediate jeopardy must be upheld unless the facility is able to prove that the determination is clearly erroneous.  42 C.F.R. § 498.60(c)(2); *Woodstock Care Center*.  The “clearly erroneous” standard means that CMS’s immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.  *See, e.g.,* *Maysville Nursing & Rehabilitation Facility*, DAB No. 2317, at 11 (2010); *Liberty Commons Nursing and Rehab Center — Johnston*, DAB No. 2031, at 18 (2006), *aff’d*, *Liberty Commons Nursing and Rehab Ctr. — Johnston v. Leavitt*, 241 F. App’x 76 (4th Cir. 2007).  When CMS issued the nursing facility survey, certification, and enforcement regulations, it acknowledged that “distinctions between different levels of noncompliance . . . do not represent mathematical judgments for which there are clear or objectively measured boundaries.” 59 Fed. Reg. 56,116, 56,179 (Nov. 10, 1994). “This inherent imprecision is precisely why CMS’s immediate jeopardy determination, a matter of professional judgment and expertise, is entitled to deference.”  *Daughters of Miriam Center*, DAB No. 2067, at 15 (2007).

DAB No. 2450 at 15 (2012).  The Board’s statement that the CMS immediate jeopardy determination is entitled to deference is subject to being misunderstood to limit ALJ and Board review of immediate jeopardy beyond what was intended by the drafters of the regulations.  In the notice of final rulemaking on November 10, 1994, the drafters of 42 C.F.R. § 498.60(c)(2), discussing the merits of the reviewability of deficiency citations, selection of remedy, and scope and severity, commented:

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We believe that a provider’s burden of upsetting survey findings relating to the level of noncompliance should be high, however.  As we indicated in the proposed rule, distinctions between different levels of noncompliance, whether measured in terms of their frequency or seriousness, do not represent mathematical judgments for which there are clear or objectively measured boundaries.  Identifying failures in a facility’s obligation to provide the kind of high quality care required by the Act and the implementing regulations most often reflect judgments that will reflect a range of noncompliant behavior.  Thus, in civil money penalty cases, whether deficiencies pose immediate jeopardy, or are widespread and cause actual harm that is not immediate jeopardy, or are widespread and have a potential for more than minimal harm that is not immediate jeopardy does not reflect that a precise point of noncompliance has occurred, but rather that a range of noncompliance has occurred which may vary from facility to facility.  While we understand the desire of those who seek the greatest possible consistency in survey findings, an objective that we share, the answer does not lie in designing yardsticks of compliance that can be reduced to rigid and objectively calculated numbers.  Survey team members and their supervisors ought to have some degree of flexibility, and deference, in applying their expertise in working with these less than perfectly precise concepts.  **For these reasons, we have revised the regulations to require an administrative law judge or appellate administrative review authority to uphold State or HCFA findings on the seriousness of facility deficiencies in civil money penalty cases unless they are clearly erroneous.**

59 Fed. Reg. at 56,179 (emphasis added).  It is clear from this regulatory history that the drafters of 42 C.F.R. § 498.60(c)(2) ensured that the state agency or CMS determination that there was immediate jeopardy would receive deferential consideration, by adopting the clearly erroneous standard of review.  Thus, caution must be exercised to ensure that the Board’s decisions in *Mississippi Care Center*, *Daughters of Miriam Center*, and other decisions that have mentioned deference relative to immediate jeopardy not be read to require deference for the determination that there was immediate jeopardy beyond that imposed by adoption of the clearly erroneous standard.  Giving deference or requiring that the immediate jeopardy determination be given deference in addition to applying the “clearly erroneous standard” would be contrary to the intent of the drafters of the regulation, would significantly limit the review of the determination by an ALJ and the

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Board, and would impermissibly deny an affected party the due process right to review intended by the drafters of the regulation.

In the foregoing quotation from *Mississippi Care Center*,that panel of the Board states that the clearly erroneous standard means that “the immediate jeopardy determination is presumed to be correct, and the burden of proving the determination clearly erroneous is a heavy one.” DAB No. 2450 at 15.  Similar formulations have been used in other Board decisions when referring to the “clearly erroneous standard.” However, the Board’s characterization of the “clearly erroneous standard” in *Mississippi Care Center* and other cases does not define the standard.  The “clearly erroneous standard” is described in *Black’s Law Dictionary* as a standard of appellate review applied in judging the trial court’s treatment of factual issues, under which a factual determination is upheld unless the appellate court has the firm conviction that an error was committed.  *Black’s Law Dictionary* 760 (8th ed. 2004).  The United States Supreme Court has addressed the “clearly erroneous standard” in the context of the Administrative Procedure Act (APA).  The Court described the preponderance of the evidence standard, the most common standard, as requiring that the trier-of-fact believe that the existence of a fact is more probable than not before finding in favor of the party that had the burden to persuade the judge of the fact’s existence.  *In re Winship*, 397 U.S. 358, 371-72 (1970) (Harlan, J., concurring); *Concrete Pipe & Prods. of Cal., Inc. v. Constr. Laborers*, 508 U.S. 602, 622 (1993).  The “substantial evidence” standard considers whether a reasonable mind might accept a particular evidentiary record as adequate to support a conclusion.  *Consol. Edison Co. of New York v. NLRB*, 305 U.S. 197, 229 (1938); *Dickinson v. Zurko*, 527 U.S. 150, 162 (1999).  Under the “clearly erroneous” standard, a finding is clearly erroneous even though there may be some evidence to support it if, based on all the evidence, the reviewing judge or authority has a definite and firm conviction that an error has been committed.  *United States v. U.S. Gypsum Co.*, 333 U.S. 364, 395 (1948); *Dickinson*, 527 U.S. at 162; *Concrete Pipe*, 508 U.S. at 622.  The clearly erroneous standard has been characterized by the Court as being stricter than the substantial evidence test and significantly deferential.  The Court stressed in discussing the clearly erroneous standard the importance of not simply rubber-stamping agency fact-finding.  The Court also commented that the APA requires meaningful review.19*Dickinson*, 527 U.S. at 162 (citations omitted); *Concrete Pipe*, 508 U.S. at 622-23.

**Page 38**

Various panels of the Board have recognized other principles applicable to the review of the immediate jeopardy issue.  A finding of immediate jeopardy does not require a finding of actual harm, only a likelihood of serious harm.  *Dumas Nursing & Rehab., L.P.*, DAB No. 2347 at 19 (citing*Life Care Ctr. of Tullahoma*, DAB No. 2304 at 58).  The definition of immediate jeopardy at 42 C.F.R. § 488.301, does not define “likelihood” or establish any temporal parameters for potential harm.  *Agape Rehab. of Rock Hill*, DAB No. 2411 at 18-19 (2011).  The duration of the period of immediate jeopardy is also subject to the clearly erroneous standard.  *Brian Ctr. Health & Rehab./Goldsboro*, DAB No. 2336 at 7-8.  There is a difference between “likelihood” as required by the definition of immediate jeopardy and a mere potential.  The synonym for likely is probable, which suggests a greater degree of probability that an event will occur than suggested by such terms as possible or potential.  *Daughters of Miriam Ctr.*, DAB No. 2067 at 10.  Jeopardy generally means danger, hazard, or peril.  The focus of the immediate jeopardy determination is how imminent the danger appears and how serious the potential consequences may be.  *Woodstock Care Ctr.*, DAB No. 1726.

What is the meaning of serious injury, harm, or impairment as used in the definition of immediate jeopardy found in 42 C.F.R. § 488.301?  How does serious injury, harm, or impairment compare with “actual harm?” On the first question, the Board recognized in *Yakima Valley School*, that the regulations do not define or explain the meaning of the term “serious” as used in the definition of immediate jeopardy.  DAB No. 2422 at 8.  The Board suggested that the definitions may be unimportant because the Board has held that, under the clearly erroneous standard, once the state agency or CMS declares immediate jeopardy there is a presumption that the actual or threatened harm was serious and the facility can only rebut the presumption of immediate jeopardy by showing that the harm or threatened harm meets no reasonable definition of the term “serious.” *Id.* (citing*Daughters of Miriam Ctr.*,DAB No. 2067 at 9).  In *Daughters of Miriam Center*, the Board discussed that the ALJ attempted in that case to define “serious,” finding meanings such as dangerous, grave, grievous, or life-threatening.  The Board notes that the ALJ stated that serious harm is outside the ordinary, requiring extraordinary care, or having lasting consequences.  The Board further noted that the ALJ stated that a serious injury may require hospitalization, or result in long-term impairment, or cause severe pain, as opposed to harm, injury, or impairment that is temporary, easily reversible with ordinary care, does not cause a period of incapacitation, heals without special medical intervention, or does not cause severe pain.  The Board did not endorse or adopt the ALJ’s definitional exercise but concluded that it was simply unnecessary in the context of that case.  The Board reasoned, as already noted, that the facility bore the burden to rebut

**Page 39**

the presumption by showing that the actual or threatened harm met no reasonable definition of serious.20*Daughters of Miriam Ctr.*,DAB No. 2067 at 9-10.

I have found by a preponderance of the evidence that Petitioner’s MARs for Resident 39, admittedly generated from Petitioner’s electronic medical records wherein the administration of insulin is recorded by Petitioner’s staff shows that there were 51 instances in July 2019 when the MARs show Resident 39 was not administered insulin per physician orders.  The MARs show there were 31 instances in August 2019.  A total of 82 times in July and August 2019, Petitioner’s MARs for Resident 39 fail to show that she received insulin as required by physician orders.  CMS Ex. 6 at 1-3, 5-6, 9-10, 55, 59-61, 65-72.

I have found by a preponderance of the evidence that Petitioner’s MARs for Resident 71 from April through August 20, 2019, show that midodrine was administered 38 times in violation of physician orders because the resident’s systolic blood pressure was greater than 130 mm Hg at the time of administration – 4 times in April, 6 times in May, 8 times in June, 12 times in July, and 8 times in August.  CMS Ex. 7 at 5, 13, 22, 30, 37.

I have found by a preponderance of the evidence that Pharma-Care consultant pharmacist reports in evidence fail to show that the pharmacist identified the errors in the MARs which indicate improper administration of insulin and midodrine for Resident 39 and Resident 71.  CMS Exs. 9 at 1-47 (June, July, 2019) and 14 (March, April, May, June, 2019), CMS Ex. 6 at 54 (Resident 39), and CMS Ex. 7 at 42-43 (Resident 71).

Petitioner placed in evidence manufacturer’s information, guidance from the ADA, and other information all of which is consistent with finding that improper administration of

**Page 40**

insulin and midodrine poses a risk for serious harm and, possibly, death.  P. Ex. 3 at 5-6, P. Ex. 4, P. Ex. 5 at 1, 3-4, P. Ex. 6, P. Ex. 7.

Applying the clearly erroneous standard to the record before me related to the noncompliance I have found, I have no definite and firm conviction that an error has been committed by the determination that immediate jeopardy existed on August 23, 2019.  Petitioner has not shown that the potential harm met no reasonable definition of the term serious.

Petitioner argues that surveyors failed to comply with SOM app. Q when they declared immediate jeopardy.  P. Br. at 17-18, 20.  Petitioner’s reliance on SOM Appendix Q is misplaced before me.  Appendix Q is a guide for surveyors discussing how to apply a regulatory standard; it does not define that standard nor is it enforceable as a regulation.  The regulations, not the SOM, are binding on ALJs and the Board.  *Pinecrest Nursing & Rehab. Ctr.*, DAB No. 2446 at 18‐19 (2012).  While Appendix Q may be instructive on the issue of immediate jeopardy, it is not controlling authority.  *Foxwood Springs Living Ctr.*, DAB No. 2294 at 9 (2009).  Petitioner cites no authority for its position that surveyor deviations from the guidance in Appendix Q, even if shown, are a basis to conclude that the declaration of immediate jeopardy is clearly erroneous.

Viewing the record as a whole, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy for the noncompliance cited based on violations of 42 C.F.R. §§ 483.21(b)(3)(i) (Tag F658) and 483.45(c)(4) and (5) (Tag F756) for one day on August 23, 2019, was clearly erroneous.

**A PICMP of $21,393 for one day of immediate jeopardy on August 23, 2019, and a CMP of $110 per day for 73 days of noncompliance from August 24, 2019 through November 4, 2019, a total CMP of $29,423, is reasonable.**I have concluded that Petitioner was not in substantial compliance with the participation requirements established by 42 C.F.R. §§ 483.21(b)(3)(i) (Tag F658) and 483.45(c)(4) and (5) (Tag F756), based violations of those regulatory requirements, which posed a risk for more than minimal harm to one or more facility residents.  I have also concluded that Petitioner failed to show that the declaration of immediate jeopardy for one day was clearly erroneous.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP.  CMS may impose a per day CMP for the number of days that the facility is not in compliance or a PICMP for each instance that a facility is not in substantial compliance with program participation requirements.  42 C.F.R. § 488.430(a).  When the survey was conducted between August 19 and 28, 2019, and the initial

**Page 41**

determination was issued on December 9, 2019, CMS was authorized to impose a per day CMP in the lower range of CMPs of $107 to $6,418 per day for noncompliance that did not pose immediate jeopardy and in the upper range of CMPs of $6,524 to $21,393 for noncompliance that posed immediate jeopardy.  CMS was authorized to impose a PICMP of $2,140 to $21,393.  42 C.F.R. §§ 488.408(d), (e); 488.438(a)(2); 45 C.F.R. § 102.3 (Table) (2019).

If I conclude, as I have in this case, that there is a basis for the imposition of an enforcement remedy and the remedy proposed is a CMP, my authority to review the reasonableness of the CMP is limited by 42 C.F.R. § 488.438(e).  The limitations are that:  (1) I may not set the CMP at zero or reduce it to zero; (2) I may not review the exercise of discretion by CMS in selecting to impose a CMP; and (3) I may only consider the factors specified by 42 C.F.R. § 488.438(f) when determining the reasonableness of the CMP amount.  In determining whether the amount of a CMP is reasonable, the following factors specified at 42 C.F.R. § 488.438(f) must be considered:  (1) the facility’s history of non-compliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as described in 42 C.F.R. § 488.404(b), the same factors CMS and/or the state were to consider when setting the CMP amount; and (4) the facility’s degree of culpability, including but not limited to the facilities neglect, indifference, or disregard for resident care, comfort, and safety – the absence of culpability is not a mitigating factor.

The factors that CMS and the state were required to consider when setting the CMP amount and that I am required to consider when assessing the reasonableness of the amount are set forth in 42 C.F.R. § 488.404(b):  (1) whether the deficiencies caused no actual harm but had the potential for minimal harm, no actual harm with the potential for more than minimal harm, but not immediate jeopardy, actual harm that is not immediate jeopardy, or immediate jeopardy to resident health and safety; and (2) whether the deficiencies are isolated, constitute a pattern, or are widespread.

My review of the reasonableness of the CMP is de novo and based upon the evidence in the record before me.  I am not bound to defer to the CMS determination of the reasonable amount of the CMP to impose but my authority is limited by regulation as already explained.  I am to determine whether the amount of any CMP proposed is within reasonable bounds considering the purpose of the Act and regulations.  *Emerald Oaks,*DAB No. 1800, at 10 (2001); *CarePlex of Silver Spring*, DAB No. 1683, at 14–16 (1999); *Capitol Hill Comty. Rehab. and Specialty Care Ctr.*, DAB No. 1629 (1997).

I have considered the regulatory factors.  There is no evidence that Petitioner has a history of noncompliance.  Petitioner comments that the total CMP of $29,423 is a large amount of money but not likely to cause a facility to close.  P. Br. at 25.  Petitioner has not presented evidence that it is unable to pay the CMP proposed by CMS.  Petitioner argues that the imposition of even a small CMP damages a facility’s business reputation

**Page 42**

and continued viability.  P. Br. at 25.  However, that is not a factor I am permitted to consider when assessing the reasonableness of a CMP.  No doubt avoiding a citation of noncompliance is a significant incentive for maintaining substantial compliance with program participation requirements as a citation of noncompliance is potentially prejudicial to a facility’s reputation.  However, that is clearly why the Secretary is authorized by Congress to survey facilities and enforce compliance through the imposition of enforcement remedies.

The deficiencies cited were serious.  Petitioner has argued throughout this case that Residents 39 and 71 (and the other residents cited as examples by the surveyors) suffered no actual harm.  P. Br.; P. Reply.  However, the measure of the seriousness of noncompliance is not measured solely by whether a resident suffered actual harm.  The manufacturer’s information, ADA guidance and other evidence produced by Petitioner shows that there is a risk for serious harm and death due to improper administration of insulin and midodrine.  P. Ex. 3 at 5-6, P. Ex. 4, P. Ex. 5 at 1, 3-4, P. Ex. 6, P. Ex. 7.  The fact that the evidence does not show actual harm for Residents 39 and 71, except for some hyperglycemia for Resident 39 (CMS Ex. 6 at 23), is fortuitous for the residents and Petitioner.  The evidence shows that there many instances when Resident 39 and Resident 71 did not receive their medication in accordance with their physician orders and the errors were committed by many members of Petitioner’s nursing staff over a period of months making this wide-spread noncompliance.  Petitioner has failed to show that the declaration of immediate jeopardy was clearly erroneous.

I also conclude that Petitioner was extremely culpable.  Petitioner complains that it was stuck with “a lousy software system that the nurses struggled with, and the Petitioner tried to have fixed prior to the survey.” P. Br. at 25; P. P. Reply at 6.  However, as Administrator Goldblatt’s testimony reveals, Petitioner had SigmaCare for five years prior to the survey and failed to take sufficient action to ensure that its records accurately reflected the health of its residents and the care and services they received even though Petitioner’s complaints are that SigmaCare was a problem from the very beginning.  Petitioner’s attempts to place the blame on its software vendor rather than accepting responsibility and taking prompt action to protect its residents from the adverse effects of inaccurate or otherwise defective medical records, emphasizes Petitioner’s culpability.  The evidence also shows that many of Petitioner’s staff was able to use the SigmaCare system to accurately document the administration of medications, despite Petitioner’s complaints about the software.

After weighing all the factors, I conclude that a PICMP of $21,393 (which is at the very top of the range authorized for PICMPs) for an instance of immediate jeopardy on August 23, 2019, and a per day CMP of $110 (which is at the very bottom of the range of authorized per day CMPs) for 73 days of noncompliance from August 24, 2019 through November 4, 2021, are reasonable.

**Page 43**

III.    Conclusion

For the foregoing reasons, I conclude that:

Petitioner was not in substantial compliance with program participation requirements from August 23 through November 4, 2019, due to violations of 42 C.F.R. §§ 483.21(b)(3)(i) (Tag F658), 483.45(c)(4) and (5) (Tag F756) each of which posed a risk for more than minimal harm to residents;

The determination of immediate jeopardy was not clearly erroneous; and

Reasonable enforcement remedies are a CMP of $21,393 per instance for one day of immediate jeopardy on August 23, 2019, and a CMP of $110 per day from August 24 through November 4, 2019.

Endnotes

1  References are to the October 1, 2018 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the August 19 through 28, 2019 survey in this case.  Appellate panels of the Board have concluded it is appropriate in long-term care facility survey cases to apply the regulatory participation requirements in the revision of the C.F.R. in effect at the time a survey was conducted.  *Good Shepard Home for the Aged, Inc.*, DAB No. 2858 at 1 n.1 (2018); *Carmel Convalescent Hosp.*, DAB No. 1584 at 2 n.2 (1996).

2  The transcript was prepared as two volumes, one volume for July 20, 2021, and one volume for July 21, 2021.  Contrary to instructions, the court reporter started numbering each volume of the transcript with “1” rather than continuously numbering across both volumes.  Therefore, citations to the transcript refer to the volume and page number such as “Tr. vol. 1 at 11” or “Tr. vol. 2 at 11.”

3  Petitioner objected to the CMS post-hearing brief on grounds that it exceeded 25 pages.  P. Reply at 1-2.  However, I specifically instructed counsel at hearing that their post-hearing brief and post-hearing reply brief could not exceed 30 pages each without leave to file a longer brief.  Tr. vol. 2 at 238.  The Prehearing Order, para. II.M.2 also advised the parties that each brief could not exceed 30 pages.  Accordingly, Petitioner’s objection to the number of pages of the CMS post-hearing brief is without merit and overruled.  Petitioner also objects that CMS failed to file proposed findings of act and conclusions of law and a list of transcript errata.  P. Reply at 1-2.  CMS filed both documents with its post-hearing reply brief.  I instructed the parties at hearing that it was permissible to file proposed findings of fact and conclusions of law and a list of errata with either of their post-hearing briefs.  Tr. vol. 2 at 238-39.  Accordingly, Petitioner’s objection is without merit, and it is overruled.

4  SNFs and nursing facilities (NFs) are often referred to as long-term care facilities or nursing homes.  NF participation in Medicaid is governed by section 1919 of the Act.  Section 1919(h)(2) of the Act gives enforcement authority to the states to ensure that NFs comply with their participation requirements established by sections 1919(b), (c), and (d) of the Act.

5  Congress granted the Secretary authority to impose enforcement remedies for noncompliance.  Act § 1819(h)(2).  The Secretary is authorized to impose CMPs as an enforcement remedy by section 1128A of the Act.  CMPs are imposed by CMS with delegated authority of the Secretary.  42 C.F.R. § 488.2.  Pursuant to subsection 1128A(j) of the Act, section 205 of the Act is applicable to the imposition of CMPs, and that section is applicable to the imposition of CMPs by both the Secretary and the Commissioner of Social Security under the authority of section 1128A of the Act.  The Inspectors General (IGs) for both HHS and the Social Security Administration (SSA) also exercise delegated authority to impose CMPs pursuant to section 1128A of the Act.  Both IGs engaged in rulemaking to specify the allocation of the burden of persuasion and the quantum of evidence required when proceeding upon a case involving a CMP.  Both the SSA IG and the HHS IG imposed upon the government in CMP cases the burden of persuasion on all issues other than affirmative defenses and mitigating factors for which the burden is upon the nongovernmental party.  The regulations of the IGs for SSA and HHS provide that the burden of persuasion is to be judged by a preponderance of the evidence.  20 C.F.R. § 498.215(b), (c); 42 C.F.R. § 1005.15(b), (d).  CMS failed to promulgate a regulation like those of the HHS and SSA IGs and the Board has filled the gap with its interpretative rules allocating the burden of persuasion to the nongovernmental party, the party defending against the imposition of the CMP.

6  “Credible evidence’ is evidence that is worthy of belief.  *Black’s Law Dictionary* 596 (8th ed. 2004).  The “weight of evidence” is the persuasiveness of some evidence compared to other evidence.  *Id*. at 1625.

7  This is a “Tag” designation as used in CMS Pub. 100-07, State Operations Manual (SOM), app. PP – Guidance to Surveyors for Long Term Care Facilities (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf).  The “Tag” refers to the specific regulatory participation requirement allegedly violated and CMS’s policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect.  *Ind. Dep’t. of Pub. Welfare v. Sullivan*, 934 F.2d 853 (7th Cir. 1991); *Nw. Tissue Ctr v. Shalala*, 1 F.3d 522 (7th Cir. 1993).  Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

8  CMS and the state agency use scope and severity levels when selecting remedies.  The scope and severity level is designated by an alpha character, A through L, selected by CMS or the state agency from the scope and severity matrix published in the SOM, chap. 7, § 7400E.  A scope and severity level of A, B, or C indicates a deficiency that presents no actual harm but has the potential for minimal harm, which is an insufficient basis for imposing an enforcement remedy.  Facilities with deficiencies of a level no greater than C remain in substantial compliance.  42 C.F.R. § 488.301.  A scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy.  A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy.  Scope and severity levels J, K, and L are deficiencies that constitute immediate jeopardy to resident health or safety.  The matrix, which is based on 42 C.F.R. § 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency.

9 Surveyor Lisa Roccia, RN, explained that the MAR forms in evidence were obtained from Petitioner.  The forms are reports generated from Petitioner’s electronic medical records and reflect the monthly compilation of the administration of medications for a resident.  According to Surveyor Roccia, nurses enter in the resident’s electronic medical record data for the administration of medication through a data input screen for the day and time the medicine is administered.  She testified that she observed one nurse make such medication administration entries.  Tr. vol. 2 at 68-74.  Petitioner’s expert witness, Nelia Adaci, RN, agreed that the MARs in evidence are not documents that appear in a resident’s record but are a report generated from the Petitioner’s electronic medical record for a resident.  Tr. vol. 2 at 233-34.

10  RN Adaci opines that the fact nurses’ initials appear on the MAR indicate insulin was given, even though the dose and site may not be indicated.  P. Ex. 2 at 8 ¶ 30; Tr. vol. 2 at 234.  I note that initials appear multiple times every day on the MARs when insulin could be administered whether the MARs indicate medication was administered (CMS Ex. 6 at 1-2, 5-6, 57, 59-61; CMS Ex. 7 at 5, 13, 22, 30, 37).  The form does not indicate on its face whether the initials are present to show the nurse on duty responsible for medication administration for the shift or whether the initials show that there was some action by the nurse.  I do not find that RN Adaci’s knowledge of the software was sufficiently established to accept her opinion weighty or credible.  I do not accept an inference that there was any action or inaction by a nurse based on the presence of the nurse’s initials on a form, particularly where the entry is the product of a software program Petitioner complains was faulty.

11  On July 30, 2019, a new order for insulin was issued which is discussed hereafter.

12  The July 30, 2019 physician orders in evidence do not specifically mention using the physician’s sliding scale.  CMS Ex. 6 at 95-96, 106.  However, because the orders do not order a specific dose of insulin, I infer that the physician intended the use of the sliding scale as reflected in the MAR.  CMS Ex. 6 at 55.

13  The systolic blood pressure is the first number or top number in a blood pressure measurement and the diastolic blood pressure is the second or bottom number of a blood pressure measurement.  Tr. vol. 2 at 40.

14  The practice of nursing is defined at N.J. Rev. Stat. § 45:11-23b.

15  CMS Ex. 6 contains other progress notes, but they are for a different resident.  CMS Ex. 6 at 189-91.

16  The regulation addressed by the Board in that case was 42 C.F.R. § 483.20(k)(3).  The requirement was subsequently moved to 42 C.F.R. § 483.21(b)(3)(i).  81 Fed. Reg. 68,688, 68,858 (Oct. 4, 2016).

17  As explained in my findings of fact I do not accept the inference suggested by RN Adaci that the presence of nurse initials or identifiers on the MARs reflects any actual action by a nurse.

18  Decisions often cited include:  *Lakeport Skilled Nursing Ctr.*, DAB No. 2435 at 7 (2012); *Liberty Health & Rehab of Indianola, LLC*, DAB No. 2434 at 13, 18-19 (2011); *Yakima Valley Sch.*, DAB No. 2422 at 8; *Lutheran Home at Trinity Oaks*, DAB No. 2111 (2007); *Britthaven of Havelock*, DAB No. 2078 (2007); *Daughters of Miriam Ctr.*, DAB No. 2067; *Koester Pavilion*, DAB No. 1750; *Woodstock Care Ctr.*, DAB No. 1726 at 39.

19  The Board’s characterization of the clearly erroneous standard as being highly deferential to the fact-finding by the state agency surveyor and CMS, and even triggering a rebuttable presumption, is entirely consistent with the Supreme Court’s characterization of the standard.  However, the Court’s cautions about ensuring meaningful review rather than rubber-stamping agency decisions show it is important for the ALJ and the Board not to be tempted to simply defer to the surveyor, the state agency, or CMS on the immediate jeopardy issue.

20  CMS subsequently provided surveyors a definition of “serious” to guide the immediate jeopardy determination.

**Serious injury, serious harm, serious impairment or death** are adverse outcomes which result in, or are likely to result in:  death; a significant decline in physical, mental, or psychosocial functioning, (that is not solely due to the normal progression of a disease or aging process); or loss of limb, or disfigurement; or avoidable pain that is excruciating, and more than transient; or other serious harm that creates life-threatening complications/conditions.
SOM app. Q, ¶ III (eff. Mar. 6, 2019) (bold in original).
  
          /s/
        Keith W. Sickendick

                      Administrative Law Judge Back to top
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