Eastern Star Masonic Home, DAB CR6065 (2022)

DECISION

Petitioner, Eastern Star Masonic Home, was not in substantial compliance with Medicare program participation requirements based on a violation of 42 C.F.R. § 483.45(f)(2) that posed a risk for more than minimal harm.1  A per-instance civil money penalty (PICMP) of $18,370 is a reasonable enforcement remedy. 

I.   Background

Petitioner is in Boone, Iowa, and participates in Medicare as a skilled nursing facility (SNF).  Centers for Medicare & Medicaid Services (CMS) exhibits (Exs.) 1 at 1; 2 at 1; Joint Stipulation of Facts and Issues Presented (Jt. Stip.) at 1 ¶ 3.  From May 28 through

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June 3, 2019, the Iowa Department of Inspections and Appeals (state agency) completed a complaint investigation and extended survey of Petitioner that was triggered by Petitioner’s self-report of an incident.  CMS Exs. 1, 3, 7 at 2 ¶ 7.  The state agency surveyor found that Petitioner was not in substantial compliance with 42 C.F.R. § 483.45(f)(2) (Tag F7602 ) at a scope and severity (s/s)3 J, which is immediate jeopardy. Pursuant to 42 C.F.R. § 483.45(f)(2), a SNF must ensure that its residents are free from significant medication errors.  The surveyor found that Petitioner had corrected the noncompliance and removed immediate jeopardy before the survey began, and she and CMS characterize the noncompliance as past noncompliance.  CMS Exs. 1 at 6; 2 at 1; 3 at 1.  On June 19, 2019, CMS notified Petitioner that it concurred with the state agency’s survey findings and imposed an $18,370 PICMP.  CMS Ex. 2.  The notice further

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informed Petitioner that it was ineligible to conduct a nurse aide training and competency evaluation program (NATCEP) for two years.  CMS Exs. 2 at 2, 3 at 1-2. 

On August 5, 2019, Petitioner filed a request for hearing before an administrative law judge (ALJ).  The case was assigned to me for hearing and decision on August 16, 2019, and an Acknowledgment and Prehearing Order (Prehearing Order) was issued at my direction.  On November 13, 2019, CMS filed CMS Exs. 1 through 7.  On December 13, 2019, Petitioner filed Petitioner’s exhibits (P. Exs.) 1 through 21. Neither party objected to the other party’s proposed exhibits and CMS Exs. 1 through 7 and P. Exs. 1 through 21 are admitted as evidence. 

On January 13, 2020, the parties filed their prehearing briefs (CMS Br. and P. Br., respectively).  The parties also filed on January 13, 2020, their joint settlement status report, in which they waived their right to an oral hearing.  On January 14, 2020, I issued an order accepting the parties’ waiver of an oral hearing subject to 42 C.F.R. § 498.66(b)(1), establishing a schedule for the parties to file reply briefs, and directing the parties to file proposed findings of fact and conclusions of law with their reply briefs.  On March 13, 2020, the parties filed their reply briefs (CMS Reply and P. Reply, respectively) with their proposed findings of fact and conclusions of law.  Accordingly, this case is ready for a decision on the documentary evidence and the briefs without the need for an oral hearing. 

II.   Discussion

A.  Issues

Whether there is a basis for the imposition of an enforcement remedy; and, if so,

Whether the remedy imposed is reasonable. 

B.  Applicable Law

1.  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) 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

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

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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.  CMS is authorized to impose a PICMP in the range 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).  

Petitioner was also notified that it is ineligible to conduct a NATCEP.  CMS Ex. 2 at 2.  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 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 extended survey of Petitioner and the PICMP proposed by CMS triggered the ineligibility to be approved to conduct a NATCEP in this case.  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). 

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

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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 NATCEP.  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). 

2.  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

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long held that the petitioner, i.e., the nongovernmental party, 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.  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 (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 and to raise a presumption, subject to being disproved or rebutted.  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 the burden shifts to Petitioner or not.  It is unclear from prior Board decisions whether CMS can make a prima facie showing with little more than mere allegations or a scintilla of evidence.  In this case, based on the following analysis, I conclude that CMS has made a prima facie showing of noncompliance by a preponderance of the evidence. 

C.  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, although not all may be specifically discussed in this decision.  I discuss the credible

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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., Administrative Law & Practice § 5:64 (3d ed. 2013). 

1.  CMS has made a prima facie showing of noncompliance by showing that Petitioner violated 42 C.F.R. § 483.45(f)(2) (Tag F760) and that the violation posed a risk for more than minimal harm to Resident 1.

2.  There is a basis for the imposition of an enforcement remedy. 

3.  Petitioner has failed to rebut the prima facie showing of noncompliance or establish an affirmative defense. 

The alleged noncompliance involved one facility resident, Resident 1.  The surveyor alleged in the statement of deficiencies (SOD) that Petitioner violated 42 C.F.R. § 483.45(f)(2) (Tag F760) because Resident 1 did not receive for four days the diuretic Bumex® as ordered by his physician.  The surveyor concluded that the medication error was significant and posed a risk for more than minimal harm to the resident.  The surveyor alleged that the medication error caused a significant decline in the resident’s condition and his subsequent hospitalization.  CMS Ex. 1 at 1. 

a.  Facts

Resident 1 was admitted to Petitioner’s facility on June 11, 2016.  Resident 1’s diagnoses listed in various clinical records in evidence, include chronic congestive heart failure – stage 4, a history of atrial fibrillation, essential hypertension, hypotension, gastro-esophageal reflux disease, Alzheimer dementia, Lewy body dementia, psychotic disorder, chronic kidney disease – stage 3, benign prostatic hypertrophy with obstructive uropathy, and depression.  CMS Ex. 4 at 1-2, 53, 59, 78-79, 113; Jt. Stip. at 1 ¶ 6.  Prescriptions listed in Resident 1’s clinical record included Abilify® and Sertraline HCL for his

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depressive disorder, Aricept® and Namenda XR® for Alzheimer’s, Bumex® for heart failure, Coreg® for hypertension, Ativan® for anxiety, Finasteride, and Flomax® for prostatic hyperplasia, and Lasix® 20 mg daily for congestive heart failure.  Jt. Stip. at 1 ¶¶ 6, 8; CMS Ex. 4 at 3-12, 25-35. 

Surveyor Sandra Simmons conducted the complaint investigation and resulting extended survey.  CMS Ex. 7 at 2 ¶ 7.  Her written direct testimony was accepted as evidence without objection by Petitioner, who waived the right to cross-examine the witness by waiving an oral hearing.  Surveyor Simmons explained her rationale for concluding a significant medication error occurred in the example of Resident 1 cited in the SOD.  She testified that, based on her knowledge and experience as a nurse and surveyor, she knows that diuretics (Lasix® and Bumex®) remove water from the body.  For one who has heart failure (such as Resident 1), removing excess fluid is necessary to prevent it from collecting in the extremities or around the lungs.  She testified that weight fluctuation is some indication of whether there is fluid retention.  CMS Ex. 7 at 3 ¶ 9.  She testified that Resident 1 had been receiving Lasix®, but on May 17, 2019, Lasix® was discontinued and Resident 1’s physician ordered that he continue to receive Bumex®.  However, Bumex® was not administered from May 17 to 21, 2019.  She found that the failure to administer Bumex® for four days was a significant medication error because Resident 1 had no diuretic for four days and required hospitalization.  CMS Ex. 7 at 4 ¶¶ 13-15.  

Petitioner does not dispute that Resident 1 did not receive Bumex® on May 18, 19, and 20, 2019, contrary to the order of his physician, Brian C. Mehlhaus, MD.  Petitioner also does not dispute that Resident 1 did not received Bumex® on May 17, 2019, but disputes that he should have received it that day.  Petitioner’s Proposed Findings of Fact & Conclusions of Law (P. PFF&CL) ¶ 27.  It is not necessary for me to decide whether Resident 1 should have received Bumex® on May 17, 2019, because the undisputed fact that he did not receive Bumex® on May 18, 19, and 20, 2019 is a sufficient factual basis for the decision in this case. 

The following facts related to the missed doses of Bumex® are found in Petitioner’s records placed in evidence by CMS.  

Progress notes show that on May 13, 2019 at about 11:30 a.m., nursing staff observed that Resident 1 had a five-pound weight gain in one day.  Examination of his legs revealed 3+ and 4+ pitting edema.  Staff notified Dr. Mehlhaus and a message was left for the resident’s daughter.  Dr. Mehlhaus ordered that Resident 1 be given Bumex®, two milligrams (mg) by mouth for three days.  CMS Ex. 4 at 17-18, 44. 

A progress note dated May 15, 2019, at 10:15 a.m. records observations of the director of nursing (DON) that Resident 1 had an unsteady gait, pallor, swelling of his face especially around his eyes, and swelling of his abdomen.  The DON notes that Resident 1 was started on Bumex® 2 mg on May 14, 2019 for three days.  She also noted his weight

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was 187.9 pounds on May 11, 2019 and 192.0 on May 15, 2019.  Both the resident’s daughter and Dr. Mehlhaus were notified and Dr. Mehlhaus was asked if he wanted laboratory testing.  On May 15, 2019, Dr. Mehlhaus ordered laboratory testing around 1:52 p.m. and results were forwarded to him between 2:00 and 2:51 p.m. the same day.  A progress noted dated May 15, 2019 at 8:44 p.m. shows that Dr. Mehlhaus ordered that Resident 1’s Bumex® be held.  CMS Ex. 4 at 16, 19, 43.  The order to hold Bumex® is also reflected by a hand-written entry on the laboratory report.  CMS Ex. 4 at 20. 

A progress note dated May 16, 2019 at 1:09 p.m. shows Resident 1 was experiencing labored breathing and he saw Dr. Mehlhaus at about 2:45 p.m. A progress note dated May 16, 2019 at 5:57 p.m. shows that nursing staff requested clarification from Dr. Mehlhaus regarding his order for Coreg®.  CMS Ex. 4 at 16, 42-43.  A progress note dated May 17, 2019 at 3:11 p.m. states that a new order was received from Dr. Mehlhaus for Lasix® and to continue Bumex®.  CMS Ex. 4 at 15, 42. 

A progress note dated May 21, 2019 at 11:37 a.m. records that a nurse called Resident 1’s family to inform them that Resident 1 had not been give his Bumex® for a few days.  A note at 12:06 p.m. on May 21, records that the charge nurse reported that Resident 1’s Bumex® had not yet arrived from the pharmacy so the nurse gave the resident the prescribed dose from Petitioner’s emergency medication kit.  Resident 1’s respiration was noted to be heavy, his abdomen was soft and rounded, and he had pitting edema to both lower extremities.  A late-entered progress note on May 21, 2019 at 3:43 p.m., records that, at 11:40 a.m., Dr. Mehlhaus ordered Resident 1 to the hospital and family was notified.  A progress note on May 21, 2019 at 3:07 p.m., shows that Resident 1 was admitted to the hospital due to congestive heart failure.  CMS Ex. 4 at 15, 40-41, 46.  A progress note dated May 23, 2019 at 11:09 a.m. and noted that Resident 1 may be discharged from the hospital on May 24, 2019.  CMS Ex. 4 at 13, 40.  A progress note dated May 24, 2019, shows that Resident 1 returned to Petitioner on May 24, 2019 at about 1:06 p.m.  CMS Ex. 4 at 39. 

The medication administration record (MAR) maintained by Petitioner for Resident 1 shows that he was prescribed Lasix® and Bumex® to address his congestive heart failure.  CMS Ex. 4 at 4-5, 6, 24, 26-27.  The MAR shows that the prescription for Lasix® started June 12, 2016 and was discontinued on May 16, 2019.  CMS Ex. 4 at 27.  The order for Bumex® started May 14, 2019, and was held from May 15 to 17, 2019.  CMS Ex. 4 at 5, 26.  A separate MAR entry lists the Bumex® as starting again on May 21, 2019.  CMS Ex. 4 at 4, 24.  The MAR shows Resident 1 received Lasix® each morning on May 1 through 16, 2019.  The MAR does not show Lasix® was administered during the remainder of May 2019.  CMS Ex. 4 at 6, 27.  An order note dated May 17, 2019, shows that a new order was received at about 3:05 p.m. that day to discontinue Lasix®, but to continue Bumex®. CMS Ex. 4 at 22.  The MAR shows that Bumex® was ordered on May 14, 2019, and was administered at 6:00 a.m. or during the day shift on May 14 and 15, 2019.  Bumex® was held and not administered per physician order on

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May 16 and 17, 2019.  Bumex® was next administered on May 21, 2019.  CMS Ex. 4 at 4-5, 26, 46.  The MAR shows Resident 1 was absent from the facility on May 22 and 23, 2019.  CMS Ex. 4 at 4.  A different copy of the MAR in evidence shows Bumex® was administered on May 21, 2019, Resident 1 was hospitalized on May 22 through 24, 2019, and Bumex® was administered May 25 through 28, 2019.  CMS Ex. 4 at 24.  Therefore, the evidence shows that Dr. Mehlhaus ordered that Bumex® be continued on May 17, 2019 at 3:05 p.m., but Bumex® was not administered on May 18, 19, and 20, 2019.  More significant is the fact that the MAR shows that Resident 1 received no Lasix® or Bumex® to address his congestive heart failure for four days, May 17, 18, 19, and 20, 2019.7   It is undisputed that on May 21, 2019, Resident 1 had to be admitted to the hospital for an exacerbation of his congestive heart failure. 

A Boone County Hospital discharge summary prepared by Dr. Mehlhaus for Resident 1 shows he was admitted to the hospital on May 21, 2019 and discharged on May 24, 2019.  CMS Ex. 4 at 53-56.  Resident 1 was reported to be an 87-year-old male.  The discharge summary states he was admitted with increasing cough and shortness of breath.  The summary also incorrectly states that he had gained 15 pounds over three-to-four days at Petitioner.  CMS Ex. 4 at 53.  Petitioner’s “Weights and Vitals Summary” for Resident 1 shows he weighed 187.9 pounds on May 11, 2019 and 192 pounds on May 15, 2019.  His weight dropped to 187.8 pounds on May 17, 2019.  Resident 1 weighed 193.4 pounds on May 19, 2019, but he weighed 187.8 pounds on May 20 and 183.8 pounds on May 21, 2019.  CMS Ex. 4 at 49; P. Ex. 2 at 3.  Therefore, according to Petitioner’s records, Resident 1’s weight had dropped 10 pounds in the days prior to his admission to the hospital on May 21, 2019. 

The discharge summary also incorrectly states that Dr. Mehlhaus ordered Bumex® on May 16, but that order was not carried out.  CMS Ex. 4 at 53.  According to the evidence, Bumex® was ordered on May 14, administered on May 14 and 15, held on May 16 17 per physician order, and then not administered on May 17, 18, 19, and 20, 2019, despite Dr. Melhaus’ order that Bumex® be continued on May 17, 2019.  CMS Ex. 4 at 4-5, 22, 24, 26, 46. 

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The discharge summary indicates that on admission Resident 1 had acute urinary retention and over 700 cubic centimeters (cc) of urine was voided when a urinary catheter was inserted.  The discharge summary also reports that Resident 1 lost 19 pounds in three days in the hospital.  CMS Ex. 4 at 53.  The parties stipulated that there were discrepancies in weights recorded for Resident 1 while he was in the emergency department and the hospital.  Jt. Stip. at 3 ¶ 27.  During evaluation in the emergency department on May 21, 2019, Resident 1 is reported to have weighed 99.79 kilograms (approximately 220 pounds).  P. Ex. 2 at 17.  However, other hospital records identify bed scale weights of 192 pounds, 3.2 ounces on May 21; 182 pounds, 9.6 ounces on May 22; 179 pounds, 1.6 ounces on May 23; and 173 pounds, 12.8 ounces on May 24, 2019.  P. Ex. 2 at 12, 14.  Jt. Stip. at 3 ¶ 27.  Petitioner’s Weights and Vitals Summary for Resident 1 show that he weighed 183.8 pounds at 7:44 a.m. on May 21, 2019.  P. Ex. 2 at 3; CMS Ex. 4 at 49.  I find that the weight of 220 pounds recorded in the emergency department on May 21, 2019, is more likely than not in error.  Weights of approximately 192 pounds on May 21, 2019 and a 182 pounds on May 22, 2019, are consistent with a hospital progress note on May 22, 2019 that reports a 10-pound weight loss.  A weight of 179 pounds on May 22, 2019 is consistent with additional loss of two pounds reported in the hospital progress note that day.  P. Ex. 2 at 29-30.  Petitioner’s “Weights and Vitals Summary” for Resident 1 shows he weighed 177.2 pounds on May 24, 2019.  I infer the weight was obtained after he was released from the hospital.  CMS Ex. 4 at 49; P. Ex. 2 at 3.  Based on Petitioner’s weights on May 21 and 24, 2019, Resident 1’s weight was down only 6.6 pounds after his discharge from the hospital.  The discrepancy between the discharge summary statement that the resident lost 19 pounds in the hospital and Petitioner’s records that show only a 6.6-pound weight loss, need not be resolved.  Clearly the resident lost weight while in the hospital.  This decision is based on the fact that Resident 1 received no medication for the treatment of his congestive heart failure on May 18, 19, and 20, 2019, and he was diagnosed on admission with an exacerbation of his congestive heart failure, a fact not in dispute and confirmed by chest x-ray.  While the amount of weight loss may be an indication of the degree or significance of Resident’s congestive heart failure and fluid overload, I have received no expert testimony that permits me to make such a determination. 

A chest x-ray was done on May 21, 2019.  The radiology report states that the x-ray revealed:  “[e]nlarged cardiac silhouette, with increased interstitial opacities bibasilar opacities and plural effusions.  Findings are often seen secondary to congestive heart failure and volume overload.”  P. Ex. 2 at 25.  Resident 1 was diagnosed in the emergency department as having congestive heart failure and renal failure.  P. Ex. 2 at 21; CMS Ex. 4 at 40.  On May 21, 2019, Resident 1 was started on intravenous Bumex® 2 mg administered every eight hours.  CMS Ex. 2 at 22.  The parties stipulated that this constitutes three times the dose of Bumex® which was prescribed while he was at the facility.  Jt. Stip. at 3, ¶ 28.  A progress note dated May 22, 2019, stated Resident 1’s weight was down 10 pounds overnight.  P. Ex. 2 at 29.  A May 23, 2019, progress note states that Resident 1 lost another two pounds.”  P. Ex. 2 at 30.  I infer that the recorded

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weight loss shows that treatment with the intravenous Bumex® was having some effect.  Absent qualified expert medical testimony, I draw no inferences related to the effectiveness of the intravenous Bumex® at a higher dose relative to the effect of an oral dose given multiple times per day. 

A chest x-ray performed on May 23, 2019, showed “small bilateral pleural effusions” consistent with congestive heart failure exacerbation and volume overload.”  The radiologist listed an impression of mild to moderate congestive heart failure exacerbation or volume overload.  P. Ex. 2 at 27.  

On May 22, 2019, Petitioner terminated the employment of Registered Nurse (RN) Wilkening, the staff member Petitioner determined was responsible for the medication error, because she failed to follow primary care physician orders, failed to follow a plan of correction pertaining to medication errors, and because her actions resulted in “the harm [and] hospitalization of a resident.”  CMS Ex. 6 at 40. 

In an unsworn statement8 dated June 20, 2019, Joshua J. Anderson, DO, Petitioner’s medial director, stated that he reviewed hospital records related to Resident 1’s admission on May 21, 2019 and records of Petitioner.  He opines that Resident 1 suffered no harm due to the missed does of Bumex®.  He notes possible errors and inconsistencies in hospital records related to Resident 1’s hospitalization.  He opines that Resident 1’health deteriorated due to his multiple medical diagnoses and not Petitioner’s failure to administer Bumex® in violation of a physician order.  He renders no opinion as to whether the fact that Resident 1 received no medication for his congestive heart failure during the period May 18 through 20, 2019, led to exacerbation of the resident’s congestive heart failure.  P. Ex. 2 at 38; CMS Ex. 6 at 26.  Even if I could consider Dr. Anderson’s unsworn statement, his opinion that the missed doses of Bumex® caused no harm is not weighty because he does not discuss whether the fact that Resident 1 had no diuretic on May 18, 19, and 20, 2019, may have caused or contributed to Resident 1’s exacerbation of congestive heart failure and fluid volume overload.  He also fails to

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explain how an exacerbation of congestive heart failure and fluid overload does not amount to harm or increased risk for harm.  

Petitioner also placed in evidence the November 27, 2019 unsworn statement of Dr. Mehlhaus, Resident 1’s treating physician.  Dr. Mehlhaus states that he was Resident 1’s treating physician for the last three years of the resident’s life.  He saw Resident 1 on May 16, 2019, for increasing shortness of breath.  He states that he switched Resident 1 from Lasix® to Bumex® 2 mg daily.  The order for Bumex® was not immediately carried out.  Resident 1 was subsequently transferred to the hospital on May 21, 2019 for worsening congestive heart failure.  He states that while there are discrepancies about scale readings, it is clear Resident 1 lost at least 8-to-10 pounds while hospitalized.  Dr. Mehlhaus opines that Petitioner’s failure to give Bumex® as ordered may have led to Resident 1’s hospitalization, but that is not 100 percent clear.  He opined that it is possible that Resident 1 may have needed intravenous Bumex®, even if the medication error had not occurred.  P. Ex. 8 at 2.  Dr. Mehlhaus’ statement is not sworn or affirmed and may not be considered as testimony.  This summary is included in the interest of thoroughness. 

Petitioner presented the written direct testimony of Robert L. Bender, II, MD.  Dr. Bender testified that he was a treating physician for Resident 1, but he does not state when.  He testified he was well‑acquainted with the resident and listed the various documents he reviewed when developing the opinions stated in his testimony.  He opined that Resident 1 experienced a loop diuretic resistance syndrome which was shown by his diminished response to the Lasix® and oral Bumex®.  He stated that the chest x-rays show some fluid retention based on the noted presence of small pleural effusions which remained even after diuresis.  He opined that Resident 1 did not sustain serious injury, serious harm, serious impairment, or death because he did not receive Bumex® as ordered.  He also opined that there was not an increased probability of serious harm, serious injury, serious impairment, or death from the missed doses of Bumex®.  P. Ex. 18.  Dr. Bender fails to reconcile his opinion and the facts which show that for four days, May 17, 18, 19, and 20, 2019, Resident 1 did not receive any medication to address his congestive heart failure and subsequently the resident had to be hospitalized for an exacerbation of congestive heart failure.  Thus, while Dr. Bender is qualified and considered credible, he simply fails to address the real issue, which is whether the failure to administer Bumex® to Resident 1 on May 18, 19, and 20, 2019 was a significant medication error (because the resident had no other diuretic medication to address his congestive heart failure and he suffered discomfort, or his health and safety were jeopardized) and whether that error posed a risk for harm or immediate jeopardy. 

Petitioner also presented the written direct testimony of Kristin S. Meyer, Pharm.D.  She testified that she reviewed various records related to Resident 1.  She also adopted her unsworn written statement of her professional opinions submitted by Petitioner.  I infer that unsworn written statement to which Ms. Meyer refers was placed in evidence as P.

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Ex. 19.  I treat P. Ex. 19 as if it were sworn to or affirmed by Ms. Meyer.  Ms. Meyer states that a medication error occurred when Resident 1 did not receive Bumex® for three days in May 2019.  She states that while she understands the error is not disputed, she cannot confirm that this was the cause for Resident 1’s hospitalization on May 21, 2019.  She states Resident 1 received Lasix® for an unknown period prior to being placed on Bumex® on May 13, 2019.  Both drugs are loop diuretics and to give both would be a duplication of medication therapy.  She states that the Bumex® was held due to a decline in kidney function and then the Lasix® was discontinued and the Bumex® was intended to be continued indefinitely.  However, the Bumex® order was not carried out for three days.  When he arrived at the hospital on May 21, 2019, Resident 1 was edematous (swollen with an excessive amount of fluid) and complained of shortness of breath but with clear lungs and normal respiratory effort.  She opined that there were many contributing factors to Resident 1’s decline that led to his hospitalization on May 21, 2019.  She further opined that the omission of Bumex® did not cause serious injury, serious harm, or serious impairment.  P.  Ex. 19.  Although Ms. Meyers is qualified and her testimony is credible, she failed to reconcile her opinions with the fact that Resident 1, who had congestive heart failure, received no diuretic for the four days (May 17, 18, 19, and 20, 2019) prior to his exacerbation of congestive heart failure and hospitalization.  She clearly does not opine that the missed doses of Bumex® and the complete absence of a diuretic for four days did not contribute to Resident 1’s exacerbation of his congestive heart failure and hospitalization.  She does not opine that the medication error caused no harm or risk of harm to Resident 1. 

Petitioner submitted the written direct testimony of its Administrator and Chief Executive Officer, Richard Colby.  Administrator Colby testified that, after being notified on May 21, 2019 of Resident 1’s change in condition and missed Bumex® doses, Dr. Mehlhaus requested that Resident 1 be sent to the hospital.  P. Ex. 13 at 2 ¶ 4.  “After Resident 1’s admission to the hospital, Dr. Mehlhaus contacted the facility and was angry about the missed doses of the medication which was his primary focus.”  P. Ex. 13 at 2 ¶ 4.  Administrator Colby testified that there were discrepancies in the various weights the hospital recorded for Resident 1 and that, during the survey, the facility attempted to “provide clarifying information” to the surveyor, but “she did not accept the written information offered for her review” and “did not ask us for the hospital records or the ability to access the records.”  P. Ex. 13 at 2 ¶ 5.  Mr. Colby asserted that the surveyor “was observed to have erratic behavior” and “emotional lability.”9   P. Ex. 13 at 2 ¶ 6.  Administrator Colby also testified that he subsequently had a conversation with Dr.

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Mehlhaus, during which Dr. Mehlhaus indicated “he was familiar with the nurse involved with the missed medications, and stated she had difficulty and lack of ability to perform her job in a satisfactory manner in other prior health care settings.”  P. Ex. 13 at 2 ¶ 8.  Administrator Colby testified that he never heard that the nurse had problems.  P. Ex. 13 at 2 ¶ 8.  He testified that Dr. Mehlhaus acknowledged there were discrepancies in the weights the hospital recorded for Resident 1 while he was admitted.  He testified that Dr. Mehlhaus acknowledged the accuracy of Petitioner’s weights for Resident 1.  Administrator Colby testified that Dr. Mehlhaus acknowledged that he had a brief conversation with the surveyor and that at the time he was not aware of the errors in the hospital weights.  P. Ex. 13 at 2 ¶ 8.  Finally, Administrator Colby asserted Dr. Mehlhaus “acknowledged Resident [1] had multiple diagnoses and symptoms which complicated and challenged the care of the resident.”  P. Ex. 13 at 2 ¶ 10. 

Petitioner presented the written direct testimony of DON Mona Lerdal.  She testified as to how the medication error, which is undisputed, is believed to have occurred.  She also testified that she spoke with Dr. Mehlhaus in November 2019.  According to DON Lerdal, Dr. Mehlhaus acknowledged discrepancies in hospital weights for Resident 1.  She testified that Dr. Mehlhaus told her that the medication error may have led to Resident 1’s hospitalization, but he could not say with 100 percent certainty.  He also indicated Resident 1 was likely to have needed Bumex® administered intravenously because patients in congestive heart failure do not absorb the diuretic enough.  DON Lerdal also testified that Dr. Mehlhaus told her that he told the surveyor that there was no harm to Resident 1.  P. Ex. 14 at 4 ¶ 21.  

The testimony of DON Lerdal and Administrator Colby shows that Dr. Mehlhaus believed that the missed doses of Bumex® contributed to the exacerbation of Resident 1’s congestive heart failure and fluid overload and required that he be hospitalized although he was not 100 percent certain.  This hearsay is considered weighty as it is consistent with other evidence of record, such as the hospital discharge summary written by Dr. Mehlhaus.  This hearsay is also offered by Petitioner who thereby waives any objection to my consideration or assignment of weight.  The assertion that Dr. Mehlhaus may have told the surveyor that Resident 1 suffered no harm is not considered weighty as there is no explanation of the basis for that opinion, which is inconsistent with the shortness of breath that Resident 1 was suffering when he was sent to the hospital for evaluation.  There is no assertion that Dr. Mehlhaus stated that Resident 1 was at no increased risk for harm due to the missed medication. 

The parties stipulated that Petitioner was cited for a significant medication error that posed a risk for more than minimal harm on June 15, 2017, only 23 months before the survey at issue in this case.  Jt. Stip. at 1 ¶ 7.  

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b.  Analysis

Long-term care facilities participating in Medicare must ensure that each resident is provided with routine and emergency drugs and biologicals.  42 C.F.R. § 483.45.  Regarding medication errors, the pharmacy services regulation requires that the facility must ensure that:  

(1) It is free of medication error rates of five percent or greater; and

(2) Residents are free of any significant medication errors.  

42 C.F.R. § 483.45(f).  There is no allegation in this case that Petitioner had a medication error rate of five percent or more.  Rather, CMS asserts that there was a significant medication error in this case.  CMS Ex. 1; CMS Br. 

In order to make a prima facie showing of noncompliance under Tag F760 based on a violation of 42 C.F.R. § 483.45(f)(2), CMS must show that: 

(1) Petitioner’s staff committed a medication error;

(2) The medication error was significant; and

(3) The violation posed a risk for more than minimal harm. 

The regulation does not define “significant.  However, the SOM and Board decisions describe a significant medication error as one that caused or may cause a resident discomfort or jeopardize a resident’s health and safety.  According to the SOM, app. PP, Tag F760, a medication error is the “observed or identified preparation or administration of medications or biologicals” not in accordance with:  prescriber’s order, manufacturer’s specifications, or accepted professional standards and principles applicable to the professional providing service.  A significant medication error is one that causes a resident discomfort or jeopardizes his or her health and safety.  The SOM states: 

Significance may be subjective or relative depending on the individual situation and duration, e.g., constipation that is unrelieved because an ordered laxative is omitted for one day, resulting in a medication error, may cause a resident slight discomfort or perhaps no discomfort at all.  However, if this omission leads to constipation that persists for greater than three days, the medication error may be deemed significant since constipation that causes an obstruction or fecal

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impaction can directly jeopardize the resident’s health and safety.

SOM, app. PP, Tag F760.  The term “jeopardize” is not defined in the SOM.  The common meaning of “jeopardize” is “to expose to danger or risk” or to “imperil.”10

The Board has stated that it is not necessary for CMS to show that there was any actual harm to support a conclusion that a medication error is significant.  Rather, a medication error may be significant if there is a potential danger or risk to a resident’s health and safety.  Life Care Ctr. of Tullahoma, DAB No. 2304 at 35 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sebelius,453 F. App’x 610 (6th Cir. 2011).  Discomfort may depend upon the individual resident.  The relative significance of medication errors is a matter of professional judgment that considers three factors:  (1) resident condition; (2) drug category; and (3) frequency of the error.  Id at 36 (citing 56 Fed. Reg. 48,853 (Sep. 26, 1991).  Similarly, the SOM provides that determining the relative significance of a medication error “is a matter of professional judgment” and directs surveyors to consider in assessing whether a medication error was significant or not, the resident’s medical condition, the drug category a medication fits within, and the frequency with which the error occurred.  SOM, app. PP, Tag F760. 

I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. § 483.45(f)(2) that posed a risk for more than minimal harm. 

Petitioner does not dispute that staff failed to give Resident 1 Bumex® on May 18, 19, and 20, 2019, in violation of the order of Dr. Mehlhaus.  P. Reply at 20; Jt. Stip. ¶ 18.  Therefore, the first element of the CMS prima facie case is satisfied by Petitioner’s concession.  

Although Petitioner concedes that a medication error occurred because Dr. Mehlhaus’ order was not followed, Petitioner argues that the medication error was not significant and, therefore, Petitioner did not violate of 42 C.F.R. § 483.45(f)(2).  P. Reply at 20. 

The SOM lists examples of medication errors that occur when a medication that was ordered was not administered and characterizes them as either significant or non-significant.  Bumex® is not one of the specifically listed medications.  Thus, there is no presumption that a medication error related to the administration of Bumex® is either significant or non‑significant.  SOM, app. PP, Tag F760. 

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Because there is no presumption that failure to administer Bumex® is a significant medication error, it is necessary to determine whether the failure to administer Bumex® to Resident 1 on May 18, 19, and 20, 2019, either caused Resident 1 discomfort or jeopardized his health and safety.  I conclude that the preponderance of the evidence shows it is more likely than not that Resident 1 suffered discomfort and his health and safety were jeopardized due to the medication error.  I further conclude CMS has made a prima facie showing that there was a risk for more than minimal harm based on the same evidence. 

Resident 1 did not receive any diuretic from May 17 through May 20, 2019.  On May 21, 2019 at about 11:40 a.m., Dr. Mehlhaus ordered that Resident 1 be sent to the emergency room.  At the time, Resident 1 was reported to be having respiratory distress, his abdomen was soft and rounded, and he had pitting edema to both lower extremities.  Resident 1 was admitted to the hospital due to congestive heart failure.  CMS Ex. 4 at 15, 40-41, 46.  Hospital records show that when admitted Resident 1 was complaining of shortness of breath.  CMS Ex. 4 at 53-56; P. Ex. 2 at 15.  A chest x-ray on May 21, 2019, confirmed that Resident 1 was suffering an exacerbation of his congestive heart failure and volume overload.  P. Ex. 2 at 27.  The evidence that Resident 1 was having some respiratory distress in the form of shortness of breath, labored breathing, and increased respirations support a finding that Resident 1 was suffering some discomfort.  The evidence also supports a finding that Resident 1’s health and safety were at risk at that time due to the exacerbation of his congestive heart failure and fluid overload. 

The fact that Bumex® was not administered on three consecutive days is further evidence that the medication error was significant.  The SOM instructs surveyors that:  

If an error is occurring repeatedly, there may be more reason to classify the error as significant.  For example, if a resident’s medication was omitted several times, it may be appropriate, depending on consideration of resident condition and medication category, to classify that error as significant. 

SOM, app. PP, Tag F760.  Here, Petitioner’s staff failed to administer Bumex® for three days.  Because Resident 1’s Lasix® had already been held or stopped, Resident 1, who had well-documented congestive heart failure, was without any diuretics for a total of four days.  Resident 1’s condition deteriorated to the point that he had to be hospitalized on May 21, 2019, and given Bumex® intravenously to reduce his fluid overload and improve his heart condition.  CMS Ex. 4 at 14, 53-56; P. Ex. 2 at 15. 

I conclude that CMS has made a prima facie showing of noncompliance under Tag F760.  Petitioner admits the medication error and the evidence shows that Resident 1 suffered discomfort and his health and safety were jeopardized.  Therefore, I find that 42 C.F.R. § 483.45(f)(2) was violated.  Furthermore, the regulatory violation posed a risk for more

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than minimal harm and amounted to noncompliance under Tag F760.  Therefore, Petitioner bears the burden to rebut the prima facie showing or to establish an affirmative defense by a preponderance of the evidence.  I conclude that Petitioner has failed to satisfy its burden. 

The gist of Petitioner’s defenses are that:  

Petitioner self-reported11 the fact that Resident 1 did not receive his Bumex® contrary to physician orders and the self-report led to an incomplete and flawed investigation by the state agency; and

Oral Bumex® would have been ineffective for Resident 1 if administered as ordered by Dr. Mehlhaus.  

P. Br. at 1-2. 

Petitioner asserts the state agency surveyor lacked clinical knowledge of Resident 1’s diseases and medications, she failed to gather necessary information including more complete hospital records and she failed to more thoroughly question the medical director, pharmacy, Resident 1’s physician, and facility staff.  P. Br. at 7-12; P. Reply at 7-9, 17-21.  Petitioner argues that the surveyor erroneously found that, because Resident 1 was not given Bumex®, he had to go to the hospital.  Petitioner argues the surveyor refused to accept information from Petitioner’s quality assurance and performance improvement program.  Petitioner argues that the surveyor behaved erratically and unprofessionally.  However, Petitioner admits that it is not possible to determine if the surveyor’s behavior affected her findings.  Petitioner argues that there is no evidence that the surveyor understood that the resident suffered from a possible loop diuretic resistance syndrome or considered it when making her findings.  Petitioner notes other possible errors and omissions by the surveyor in reaching her findings and conclusions, including failure to resolve inconsistencies in hospital weights of Resident 1, the fact that Dr. Mehlhaus was unaware of Resident 1’s weights and stated that Bumex® was started on May 16, 2019.  Petitioner argues that the surveyor’s errors make it impossible for CMS to make a prima facie case.  P. Br. at 7-12. 

Petitioner’s challenges to the CMS prima facie case based on the performance of the surveyor are without merit in this forum.  The Board has been consistent in holding that inadequate survey performance is irrelevant to ALJ and Board review of a CMS

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determination of noncompliance.  Avon Nursing Home, DAB No. 2830 at 11.  In Libertyville Manor Rehab. & Healthcare Ctr. the Board explained: 

Even if Petitioner's complaints about how the survey-and-enforcement process unfolded had been factually substantiated, they would still be legally irrelevant because they do not call into question the validity of any appealable noncompliance determination. See 42 C.F.R. § 488.318(b) (stating that “[i]nadequate survey performance does not . . . [r]elieve a SNF . . . of its obligation to meet all requirements for program participation” or “[i]nvalidate adequately documented deficiencies”); Nightingale Home Healthcare, Inc., DAB No. 2784, at 11 (2017) (holding that the administrative appeal process under 42 C.F.R. Part 498 “do[es] not provide for a review of surveyor performance”; that “evidence about the survey process is not relevant where the provider has not shown how any alleged defects in the conduct of the survey . . . undercut or impeach the evidence of noncompliance offered by CMS”; and that the ALJ committed no error in “disregarding . . . complaints about the survey process itself that did not relate to evidence concerning the facts of [the SNF's] compliance status”); Ne. Ohio Alzheimer's Research Ctr., DAB 1935, at 8 (2004) (noting that the goal of the survey-and-enforcement process is to ensure that “all deficient providers are appropriately sanctioned” and that this goal “is in direct conflict with the idea that a noncompliant facility may avoid a remedy based on a defense that does not negate or remove the factual basis for a finding of noncompliance”) (internal quotation marks omitted). 

DAB No. 2849 at 23 (2018).  In Avon, the Board explained that:  

[U]nder the governing administrative appeal regulations, the ultimate issue before an ALJ is not how the state agency performed the survey or what process it followed to reach its conclusions, but “whether the evidence as it is developed before the ALJ supports” CMS’s independent “finding of noncompliance” under the relevant participation requirements . . . .  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 conclusions and based on [his or her] own evaluation of the credibility of the submitted evidence. 

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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. 

Avon Nursing Home, DAB No. 2830 at 11-12 (emphasis in original) (citations omitted). 

The Boards position is consistent with 42 C.F.R. § 488.318(b) which provides:  

(b) Inadequate survey performance does not—

(1) Relieve a SNF or NF of its obligation to meet all requirements for program participation; or

(2) Invalidate adequately documented deficiencies. 

Petitioner’s allegations that the surveyor’s investigation was not comprehensive or thorough and the allegations that the surveyor’s behaviors were erratic (P. Reply at 17-20), even if true, do not undermine the credibility of the evidence upon which CMS relies in this case for its prima facie showing.  The fact that Resident 1 did not receive Bumex® on May 18, 19, and 20, 2019, in violation of physician’s orders, has been conceded by Petitioner.  The fact Resident 1 was admitted to the hospital on May 21, 2019 due to exacerbation of his congestive heart failure and fluid overload is not disputed.  Discrepancies in hospital weights and other errors in hospital records are recognized, but they do not detract from the objective evidence, such as the chest x-ray on May 21, 2019 and its interpretation that it was consistent with congestive heart failure and fluid overload.  CMS Ex. 4 at 40 (May 21, 2019 progress note at 4:25 p.m., which is consistent with x-ray findings at P. Ex. 2 at 25).  My conclusion that CMS has made a prima facie showing by a preponderance of the evidence that there was noncompliance under Tag F760 is not based on the surveyor’s allegations, but is based on the actual evidence of record.  Petitioner’s attacks on the surveyor do not undermine the credibility of the evidence. 

Petitioner’s second line of defense is that oral Bumex® would not have been effective for Resident 1, even if it had been administered as ordered.  Petitioner points to the fact that both Bumex® and Lasix® were administered on May 14 and 15, 2019, but Resident 1’s condition worsened in that he had swelling around his eyes and in the abdomen and his weight was up two pounds.  Petitioner argues that, despite receiving both loop diuretics on May 14 and 15, 2019, the resident’s congestive heart failure worsened and “he ended up in the hospital with worsening [congestive heart failure] because no effective

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treatment had been initiated.”  P. Reply at 4.  Petitioner appears to concede that Resident 1 was sent to the emergency room on May 21, 2019 due to his worsening congestive heart failure.  Petitioner argues that, because taking Bumex® orally was ineffective for Resident 1 due to the resident’s “advancing” congestive heart failure, its failure to administer the oral Bumex® as ordered did not cause Resident 1 discomfort or jeopardize his health and safety.  P. Reply at 11.  If, as Petitioner concedes, Resident 1’s congestive heart failure was worsening on May 14 and 15, 2019, the fact that Lasix® was discontinued on May 16, 2019 and the Bumex® that was ordered on May 17, 2019 was not administered on May 18, 19, and 20, 2019, make it difficult, if not impossible, for Petitioner to show that it was more likely than not that Resident 1’s hospitalization on May 21, 2019 was not avoidable, even if he received the Bumex® as ordered by Dr. Mehlhaus.  If Resident 1 had received oral Bumex® as ordered on May 18, 19, and 20, 2019, and his congestive heart failure still worsened, Petitioner would have a more credible argument, but those are not the facts.  Petitioner even argues, without the benefit of medical expert testimony, that Dr. Mehlhaus mis-diagnosed the severity of Resident 1’s congestive heart failure because he did not recognize Resident 1 was experiencing a loop diuretic resistance syndrome.12   P. Reply at 4.  Petitioner’s theory that Resident 1 was experiencing a loop diuretic resistance syndrome causing Lasix® and Bumex® to be ineffective on May 14 and 15, 2019 is based on speculation and conjecture and therefore is rejected.13  

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Petitioner cites the testimony of Ms. Meyer and Dr. Bender in support of its theory that failure to administer oral Bumex® on May 18, 19, and 20, 2019, had no significant effect on Resident 1 and did not cause or pose any risk for serious injury, serious harm, serious impairment, or death.  P. Br. at 12-13.  I do not find the testimony of these witnesses weighty, certainly not weighty enough to satisfy Petitioner’s burden of persuasion.  

Dr. Bender testified he was Resident 1’s treating physician, though he does not say when or for what he treated Resident 1.  P. Ex. 18 at 1.  Resident 1’s Admission Record lists Dr. Mehlhaus and Rebecca Metzger as his care providers, not Dr. Bender.  CMS Ex. 4 at 1.  Resident 1’s MARs list Dr. Mehlhaus as Resident 1’s physician.  CMS Ex. 4 at 3-12, 25-35.  Progress notes for Resident 1 list Dr. Mehlhaus as Resident 1’s physician.  CMS Ex. 4 at 13, 15-19, 36, 43-45.  Resident 1’s care plans also list Dr. Mehlhaus as his physician.  CMS Ex. 4 at 101-13.  I do not find Dr. Bender’s opinions weightier due to a treating relationship with Resident 1, as it is not clear when he last treated the resident, and clinical records in evidence do not reflect his involvement in control of Resident 1’s congestive heart failure and hospitalization in May 2019.  Dr. Bender opines that Resident 1 experienced a loop diuretic resistance syndrome, and he bases his opinion on the resident’s response to the Lasix® and oral Bumex®.  P. Ex. 18 at 2.  Dr. Bender does not specifically identify the response of Resident 1 to Lasix® and oral Bumex® or when that response occurred.  I also infer that Dr. Bender is referring to the response when Lasix® and Bumex® were administered on the same day.  The MAR shows that Lasix® was prescribed for Resident 1 beginning June 12, 2016 and it was discontinued by Dr. Mehlhaus on May 16, 2019, and not administered thereafter in May 2019.  CMS Ex. 4 at 6, 27.  The MAR shows Bumex® was started on May 14, 2019, but it was held per Dr. Mehlhaus’ order on May 15, 16, and 17, 2019.  CMS Ex. 4 at 5, 26.  The MAR shows that a dose of Bumex was administered during the morning on May 14 and 15, 2019.  One dose of Bumex® was administered on May 21, 2019, before Resident 1 was sent to the emergency room.  CMS Ex. 4 at 4, 24.  Therefore, according to Petitioner’s records, Resident 1 received Lasix® and Bumex® on only two days, May 14 and 15, 2019.  Dr. Bender does not explain how he can diagnose that Resident 1 suffered a loop diuretic resistance syndrome based on only two days of overlap of Lasix® and Bumex®, particularly with not having examined Resident 1 and absent any laboratory testing.  Dr. Bender’s opinion that Resident 1 had a diminished response to Lasix® and Bumex®, I infer that was on May 14 and 15, 2019, the only two days he received both, is totally unsupported by any evidence in the record or described by Dr. Bender.  Therefore, I do not find Dr. Bender’s diagnoses or opinions credible.  Dr. Bender also fails to explain how, if Resident 1 did suffer a loop diuretic resistance syndrome, Dr. Mehlhaus apparently successfully treated Resident 1 with oral Bumex® 2 mg once per day after his

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release from the hospital.14   CMS Ex. 4 at 24, 35-39.  Dr. Bender also fails to mention or address how in developing his opinions he considered the facts that Resident 1, who had known congestive heart failure (CMS Ex. 4 at 78, Minimum Data Set, reference date Mar. 6, 2019), received no diuretic on May 17, 18, 19, and 20, 2019.  Dr. Bender does not explain why it is more likely than not that Resident 1’s hospitalization due to an exacerbation of congestive heart failure and fluid overload was due to Resident 1 not receiving diuretic for four days, rather than a loop diuretic resistance syndrome.  The fact that Dr. Mehlhaus reportedly commented that patients like Resident 1 sometimes do not absorb diuretics, unless administered intravenously, lends some credibility to Dr. Bender’s opinions.  However, there is no report showing that Dr. Mehlhaus said he determined that was the case with Resident 1, and any such opinion would be suspect given that Resident 1 had no diuretics for four days before his hospitalization.  Finally, I reject Dr. Bender’s opinions that Resident 1 suffered no harm and there was no risk for serious injury, serious harm, serious impairment, or death because he did not receive Bumex® on May 18, 19, and 20, 2019, when the resident was receiving no other diuretic.  P. Ex. 18 at 3.  Dr. Bender provides no examples of what he considers to be serious.  Although he does not specifically articulate the basis for his opinion, it is more likely than not that in developing the opinion, he considered his loop diuretic resistance syndrome theory and the notion that oral Bumex® would not have been helpful to avoid the exacerbation of Resident 1’s congestive heart failure had it been administered as prescribed.  Dr. Bender also opines that the treatment Resident 1 received at the hospital could have been administered at Petitioner.  P. Ex. 18 at 3.  Dr. Bender does not explain why he believes that to be the case.  He also does not explain why his opinion that Resident 1 did not need to be hospitalized should be given greater weight than Dr. Mehlhaus’ opinion and order that Resident 1 needed to be sent to the emergency room for evaluation and treatment as ordered by the emergency department physician. 

I also find the opinions of Ms. Meyer are entitled to little weight.  Ms. Meyer states that she cannot confirm that the fact Resident 1 did not receive Bumex® on May 18, 19, and 20, 2019, “was the cause of his hospitalization on May 21, 2019.”  P. Ex. 19 at 1.  Ms. Meyer does not opine that the medication error did not cause Resident 1’s hospitalization on May 21, 2019.  Ms. Meyer recognizes that Resident 1 had been receiving Lasix®.  He was then given Bumex®, which was held due to a decline in kidney function.  Subsequently, Lasix® was discontinued and the resident was supposed to be given Bumex® but that order was not carried out for three days.  She also notes that Coreg® was increased slightly on May 18, 2019, with no adverse effect.  P. Ex. 19 at 1.  She does

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not explain how the change in Coreg® may be relevant to Resident 1’s exacerbation of congestive heart failure and fluid overload.  Ms. Meyer notes that, on arrival at the hospital, Resident 1 was edematous and complained of shortness of breath but, based on his electrolytes, she did not think he was significantly fluid overloaded from his congestive heart failure.  P. Ex. 19 at 2.  Ms. Meyer does not state she examined Resident 1 on May 21, 2019.  Ms. Meyer stated that Resident 1 had a complicated medical and medication history with many possible contributors to his overall decline in health status.  I have no reason to question the forgoing observations and opinions.  However, Ms. Meyer opines that the “omission of Bumex® at the nursing facility” did not lead “to serious injury, serious harm or serious impairment.”  P. Ex. 19 at 2.  Ms. Meyer did not opine that the medication error did not pose a risk for more than minimal harm to Resident 1 or that it did not cause him discomfort.  She does not opine that the medication error did not lead to or contribute to Resident 1’s exacerbation of his congestive heart failure and fluid overload.  She also does not explain why an exacerbation of known congestive heart failure and fluid overload does not pose a risk for serious injury, harm, or impairment, and her opinion that there was no such risk is unsupported and not entitled to weight. 

Petitioner argues that Resident 1 was transferred to the hospital on May 21, 2019, because his nurse observed he was very restless and was breathing faster.  P. Reply at 7.  However, Petitioner’s records show Resident 1 was short of breath and not just breathing faster.  CMS Ex. 4 at 46.  In fact, a progress note dated May 21, 2019 at 12:06, signed by RN Elliott, indicates that Resident was visibly short of breath and his respirations were 40 per minute and heavy.  CMS Ex. 4 at 41.  The parties stipulated that Resident 1 was visibly short of breath on May 21, 2019 prior to going to the emergency room.  Jt. Stip. at 3 ¶ 24.  The emergency department physician documented that Resident 1 had a complaint of shortness of breath and that Resident 1 was having increased “work of breathing and increased respiratory rate just today, which prompted his RN to recommend [emergency department] evaluation.”  P. Ex. 2 at 15.  The emergency department physical examination described Resident 1’s respiratory pattern as tachypnea (abnormally rapid breathing) with a respiratory rate of 20 to 30, but also states that the resident’s respiratory effort was normal, and the resident denied respiratory distress.  P. Ex. 2 at 17-18.  The chest x-ray ordered by the emergency department physician showed signs consistent with congestive heart failure and volume overload.  P. Ex. 2 at 21, 25. 

Petitioner argues that the discomfort Resident 1 was suffering on May 21, 2019, was related to his obstructive uropathy and the fact he had more than 700 cc of urine in his bladder that he could not void and was resolved after the resident voided.  P. Reply at 7, 11.  Whether or not the amount of urine in Resident 1’s bladder was causing him discomfort and possibly causing him to breath faster is not the issue.  The issue is whether the failure to administer Bumex® for three days following one day with no Lasix® more likely than not caused Resident 1 discomfort or jeopardized his health and safety.  Petitioner speculates Resident 1’s discomfort was solely attributable to the fact

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Resident 1’s bladder was extremely full, and the resident could not void.  However, Petitioner’s speculation cannot be given greater weight than the objective evidence in the form of the chest x-ray and the emergency department physician’s assessment that Resident 1 was suffering an exacerbation of congestive heart failure and fluid overload.  Petitioner offers no evidence that Resident 1 was not suffering discomfort from both his congestive heart failure and his full bladder.  The fact Resident 1 was short of breath, according to Petitioner’s records, is good and credible evidence that Resident 1 was having discomfort associated with his breathing and more likely than not that discomfort was secondary to his exacerbation of congestive heart failure and fluid overload as shown by the x-ray and physician assessment done shortly after his arrival at the hospital. 

Petitioner argues that “failing to administer an ineffective medication on multiple occasions does not rise to the level of a significant medication error” in this case.  P. Reply at 11.  Dr. Mehlhaus ordered oral Bumex® for Resident 1 that Petitioner did not ensure was administered on May 18, 19, and 20, 2019.  For the reasons already discussed, Petitioner has failed to show by a preponderance of the evidence that the Bumex®, if administered as ordered, would not have been effective to treat Resident 1’s congestive heart failure and to avoid discomfort and jeopardy to his health and safety.  

I also note that Petitioner fired RN Wilkening on May 22, 2019, the day after it was discovered Resident 1 had not been administered Bumex® on May 18, 19, and 20, 2019.  The Notice of Corrective action related to the termination of RN Wilkening, who was clearly terminated due to the medication error, states the plan of corrective action was her “immediate termination because her negligent actions and disregard for policies and procedures resulted in the harm and hospitalization of a resident.”  CMS Ex. 6 at 40.  Therefore, Petitioner clearly recognized the harm to Resident 1 due to the missed doses of Bumex®.  

There is no dispute that Resident 1 was not given a dose of Bumex® on May 18, 19, and 20, 2019.  (P. PFF&CL) ¶ 27.  I conclude that three consecutive days of missed doses meets the definitions of “repeatedly” and “several times” which the SOM describes as indicating that a medication error is significant.  SOM, app. PP, Tag F760. 

I find and conclude based on my review of all the evidence that Petitioner has failed to meet its burden of persuasion to show by a preponderance of the evidence that the admitted medication error was not significant.  In attempting to rebut CMS’ prima facia case, it is not sufficient for Petitioner to merely create uncertainty about whether the medication error was significant or doubt over whether it led to Resident 1’s worsening condition and subsequent hospitalization.  Actual harm need not occur for a medication error to be significant or for there to be a risk for more than minimal harm.  In this case Petitioner bears the burden to show that Resident 1 had no discomfort due to the medication error and that his health and safety were not jeopardized in order to establish that the medication error was not significant.  Life Care Ctr. of Elizabethton, DAB No.

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2367 at 6 (2011).  If the medication error is determined to be significant, Petitioner also bears the burden to show that the regulatory violation did not pose a risk for more than minimal harm.  The evidence Petitioner put forward is not sufficient to meet either burden.  Therefore, Petitioner has failed rebut CMS’s prima facie showing that Petitioner violated 42 C.F.R. § 483.45(f)(2) (Tag F760), and that the violation posed a risk for more than minimal harm to Resident 1.  Accordingly, I conclude that Petitioner was not in substantial compliance with the program participation requirement established by 42 C.F.R. § 483.45(f)(2). 

4.  The declaration of immediate jeopardy due to the noncompliance based on a violation of 42 C.F.R. § 483.45(f)(2) (Tag F760) was not clearly erroneous. 

I also conclude that CMS’s determination that the noncompliance under Tag F760 posed immediate jeopardy was not clearly erroneous.  The surveyor concluded that the immediate jeopardy was abated on May 24, 2019 when Petitioner completed retraining its staff regarding physician orders and based on quality assurance efforts related to medication administration.  CMS Ex. 1 at 6. 

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,

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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). 

Many appellate panels of the Board have addressed “immediate jeopardy.”15   In Mississippi 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

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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: 

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. 

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59 Fed. Reg. at 56,179 (emphasis added).  It is clear from this regulatory history that, by adopting the clearly erroneous standard of review, the drafters of 42 C.F.R. § 498.60(c)(2) sought to ensure that the determination of immediate jeopardy by a state agency or CMS would receive deferential consideration.  Thus, caution must be exercised to ensure that the Board’s decisions in Mississippi Care Ctr., Daughters of Miriam Ctr., 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 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 269 (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. N.L.R.B., 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. 

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The Court also commented that the APA requires meaningful review.16   Dickinson, 527 U.S. at 162 (citations omitted); Concrete Pipe, 508 U.S. at 622-23. 

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 (2010), aff’d, Life Care Ctr. of Tullahoma v. Sec’y of U.S. Dep’t of Health & Human Servs., 453 F. App’x 610).  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 Ctr., the Board

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

Applying the clearly erroneous standard to the record before me related to CMS’s determination of noncompliance at the immediate jeopardy level, I have no definite and firm conviction that an error has been committed. 

Petitioner contends that it was in substantial compliance with the participation requirements and, therefore, CMS’s immediate jeopardy determination “is a non-issue that does not need to be addressed.”  P. Br. at 14-17; P. Reply at 21-22.  Petitioner argues that the declaration of immediate jeopardy was clearly erroneous based on what Petitioner characterizes as the surveyor’s and the state agency’s failure to take into account the "totality of the circumstances," lack of thorough investigation in obtaining the hospital records and interviewing hospital personnel, and a failure to understand the complex clinical condition and medication interactions involved with Resident 1.  P. Br. at 14.  Petitioner asserts that the record is unclear as to who at the state agency made the initial decision to declare immediate jeopardy and contends that CMS did not give sufficient weight to the opinions of Petitioner’s expert witnesses when CMS made its immediate jeopardy determination.  P. Reply at 22.  I have found for reasons already discussed that, contrary to Petitioner’s arguments, there was noncompliance under Tag F760 and that the noncompliance posed a risk for more than minimal harm to Resident 1.  CMS made a prima facie showing of noncompliance that Petitioner has failed to rebut or establish an affirmative defense by a preponderance of the evidence. 

Petitioner has failed to show that Resident 1, who clearly was suffering congestive heart failure and fluid overload on May 21, 2019, was not likely to suffer serious injury, harm, impairment, or death due to the fact he did not receive a diuretic for four days, including May 18, 19, and 20, 2019, dates on which Petitioner admits Resident 1 did not receive Bumex® as ordered by his physician, Dr. Mehlhaus.  Petitioner’s witnesses’ opinions are not weighty for the same reasons they are not weighty on the issue of whether the medication error was significant, and do not show any clear error in the declaration of immediate jeopardy. 

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Based on the foregoing, Petitioner has not shown that its noncompliance with 42 C.F.R. § 483.45(f)(2) (Tag F760) did not cause, and was not likely to cause, serious injury, harm, impairment, or death to Resident 1.  42 C.F.R. § 488.301.  Therefore, I conclude that Petitioner has failed to show that the declaration of immediate jeopardy was clearly erroneous. 

5.  A per-instance CMP of $18,370 is a reasonable enforcement remedy. 

I have concluded that Petitioner violated 42 C.F.R. § 483.45(f)(2) (Tag F760).  Based on that violation, Petitioner was not in substantial compliance with program participation requirements from at least May 18 through May 20, 2019.  The violation of 42 C.F.R. § 483.45(f)(2) (Tag F760) caused actual harm to Resident 1, including exacerbation of his congestive heart failure and fluid overload, ultimately requiring hospitalization.  I have also concluded that the declaration of immediate jeopardy related to the noncompliance under Tag F760 was not 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, whether the noncompliance poses immediate jeopardy or not.17   42 C.F.R. § 488.430(a).  The regulation at 42 C.F.R. § 488.438(a)(2) specifies that a per-instance CMP will range from $1,000 to $10,000, as adjusted annually at 45 C.F.R. part 102.  In this case, CMS imposed the per-instance CMP on June 19, 2019.  For per-instance CMPs imposed between October 11, 2018, and November 5, 2019, the applicable range was $2,140 to $21,393.  45 C.F.R. § 102.3 (2019); 83 Fed. Reg. 51,369, 51380 (Oct. 11, 2018); 84 Fed. Reg. at 59,459, 59,559, (Nov. 5, 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:  (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

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of noncompliance, including repeated deficiencies; (2) the facility’s financial condition; (3) the seriousness of the deficiencies as set forth at 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 facility’s neglect, indifference, or disregard for resident care, comfort, and safety, and 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, 60 DAB No. 1800 at 10 (2001); CarePlex of Silver Spring, DAB No. 1683 at 14-16 1999); Capitol Hill Cmty. Rehab. & Specialty Care Ctr., DAB No. 1629 (1997). 

The PICMP of $18,370 imposed by CMS is reasonable.  Petitioner had a history of a citation of noncompliance for a significant medication error that posed a risk for more than minimal harm.  Jt. Stip. at 1, ¶ 7.  Petitioner did not submit any evidence regarding its financial condition and nothing in the record demonstrates that an $18,370 CMP would place the facility in a precarious financial condition.  Further, the severity of the noncompliance at issue is significant.  Although the significant medication error was limited in scope in the sense that it was limited to one facility resident, that deficiency nevertheless persisted for at least three consecutive days and posed immediate jeopardy.  I also find Petitioner’s culpability to be significant.  The regulation at 42 C.F.R. § 488.438(f) provides that in reviewing a facility’s culpability I must consider a “facility’s neglect, indifference, or disregard for resident care, comfort, and safety.”  Here, Petitioner itself described RN Wilkening’s conduct as exhibiting a “disregard for policies and procedures” and that her failure to ensure Resident 1’s Bumex® order was implemented was “negligent.”  CMS Ex. 6 at 40. 

Finally, I note that, because Petitioner’s staff failed to administer Bumex® to Resident 1 for at least three consecutive days, CMS presumably had discretion to impose a per-day CMP for each of those days instead of the per-instance CMP it chose here, which very well may have resulted in a significantly higher penalty.  See Plum City Care Ctr., DAB No. 2272 at 18-19 (2009) (observing, in a case where a facility was not in substantial compliance for multiple days, that a maximum per-instance CMP was “actually a modest penalty when compared to what CMS might have imposed.”).  Considering the

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foregoing, I conclude that a per-instance CMP of $18,370, which is not the maximum authorized, is a reasonable enforcement remedy.18

III.   Conclusion

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with the program participation requirements at 42 C.F.R. § 483.45(f)(2) and that the non-compliance posed immediate jeopardy.  A PICMP of $18,370 is a reasonable enforcement remedy.  

1. Citations are to the 2018 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the survey, unless otherwise indicated.  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).
• back to note 1
2. This is a “Tag” designation as used in CMS Pub.100-07, State Operations Manual (SOM), Appendix PP – Guidance to Surveyors for Long Term Care Facilities, rev. 173, eff. November 28, 2017 (https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/downloads/appendix-pp-state-operations-manual.pdf) (last visited March 3, 2022).  The “Tag” refers to the specific regulatory provision allegedly violated and CMS policy guidance to surveyors.  Although the SOM does not have the force and effect of law, the provisions of the Act and regulations as interpreted in the SOM 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 of Health and Human Services (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.
• back to note 2
3. Scope and severity levels are used by CMS and a state 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 SOM, ch. 7, § 7400.5.1 (rev. 63, Sep. 10, 2010).  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 not considered “noncompliance,” and 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 indicate 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 which are optional at each level based upon the frequency of the deficiency.
• back to note 3
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.
• back to note 4
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.
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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.
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7. The MAR also shows that Resident 1 was prescribed Coreg® beginning May 17, 2019.  The parties stipulated that Coreg® may be used to treat congestive heart failure and hypertension.  Jt. Stip. at 2 ¶ 14.  However, the diagnosis listed on the MAR for that medication is essential (primary) hypertension not congestive heart failure.  The Coreg was held from May 16 to 18, 2019.  The MAR shows Coreg was administered in the evening on May 18, twice on May 19 and 20, and the morning of May 21, 2019, I infer before Resident 1 was sent to the hospital.  CMS Ex. 4 at 8, 30.
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8. Witnesses are required to testify under oath or affirmation.  42 C.F.R. § 498.62; Prehearing Order ¶ II.L.8.  Dr. Anderson’s statement is not sworn or affirmed and may be rejected as incompetent evidence on this basis alone.  The statement is discussed here in the interest of thoroughness.  The same is true for the unsworn written statement of Dr. Mehlhaus discussed next.  A party to these proceedings may not avoid the need to present witness testimony that is sworn or affirmed subject to the penalty for perjury and is subject to cross-examination by the simple expedient of offering unsworn written statements, even when CMS waives the right to cross-examination of all witnesses by agreeing to a waiver of oral hearing.
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9. “[A]llegations of inadequate survey performance are irrelevant to ALJ or Board review of CMS’s noncompliance and remedy determinations.”  Avon Nursing Home, DAB No. 2830 at 11 (2017); 42 C.F.R. § 488.318(b).
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10. Merriam-Webster, www.merriam-webster.com/dictionary (last visited Apr. 5, 2022).
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11. Petitioner does not specifically assert that the fact it “self-reported” to the state agency is any defense to the noncompliance.
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12. Petitioner further questions Dr. Mehlhaus’ judgment by asserting that Resident 1 was at increased risk by taking Bumex®.  Petitioner cites as evidence a print of a website, GoodRx.  P. Ex. 7.  CMS did not object to the admission of P. Ex. 7 as evidence and it was admitted absent a challenge to its authenticity and relevance.  However, given the very nature of websites, including uncertainties inherent in their creation and accuracy of their content, I generally give little or no weight to such evidence.  Petitioner offered the testimony of Ms. Meyer who has a Doctor of Pharmacy degree and who could have addressed any identifiable risk to Resident 1 from Bumex®.  Whether or not Bumex® posed a risk, it was ordered by Resident 1’s treating physician and Petitioner failed to administer it.  There is no evidence that Petitioner’s medical director or other qualified staff or consultants made a medical determination to not administer the medication due to assessed risk to the resident.  Therefore, the argument that Bumex® was potentially dangerous to Resident 1 does not excuse Petitioner’s failure to ensure that staff administered the drug in accordance with the resident’s physician’s order.
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13. Counsel for both parties pursue arguments and make assertions related to medical diagnoses, medication effects, signs and symptoms of illness, and other medical matters beyond the knowledge and experience of those not trained in medicine, without the benefit of medical expert testimony or other credible scientific evidence in the record.
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14. Petitioner argues that there is a simple explanation, i.e., that the hospital treatment was effective and created enough improvement to overcome the loop diuretic resistance syndrome so that the oral Bumex® was effective.  P. Reply at 4-5.  Petitioner advances this argument with no supporting expert opinion or other competent evidence.
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15. 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.
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16. 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 caution 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.
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17. For this reason, the declaration of immediate jeopardy in this case is irrelevant, except to the extent the declaration of immediate jeopardy reflects the seriousness of the noncompliance which may be considered in determining the reasonableness of the PICMP imposed.
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18. Because Petitioner was subject to an extended survey and the amount of the PICMP, Petitioner was ineligible to be approved to conduct a NATCEP for two years pursuant to section 1819(f)(2)(B)(iii)(I)(b), (c) of the Act and 42 C.F.R. §§ 483.151(b)(2)(iii), (iv), (f)(1).
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