South Shore Rehabilitation, LLC/d/b/a South Shore Rehabilitation and Nursing Center, DAB CR5789 (2020)

DECISION

In these consolidated appeals, I consider whether a long-term-care facility is responsible for the errors made by its contractors and whether putting the wrong label on a drug violates the requirement that drugs be labeled in accordance with accepted professional principles.   

Petitioner, South Shore Rehabilitation LLC, is a long-term-care facility, located in Freeport, New York, that participates in the Medicare program.  Following a survey completed on May 30, 2018, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with the Medicare program requirements that govern the labeling of drugs and biologicals, 42 C.F.R. § 483.45(g), and that its deficiencies posed immediate jeopardy to resident health and safety.  Based on the same findings, CMS subsequently determined that the facility was not in substantial compliance with two additional requirements:  42 C.F.R. § 483.45(f)(2), which requires that residents be free of significant medication errors; and 42 C.F.R. § 483.10(g)(14), which requires that the facility immediately consult the resident’s physician whenever there is a significant change in his condition.

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CMS has imposed civil money penalties (CMPs) of $13,199 per day for two days of immediate jeopardy and $505 per day for 55 days of substantial noncompliance that did not pose immediate jeopardy.

Petitioner appeals.  CMS moves for summary judgment, which Petitioner opposes.

For the reasons set forth below, I grant CMS’s motion.  The evidence in this case is undisputed, and the case’s outcome turns on questions of law.  Based on the law and the undisputed evidence, I find that the facility was not in substantial compliance with Medicare program requirements, its deficiencies posed immediate jeopardy to resident health and safety, and the penalties imposed are reasonable. 

Background

The Social Security Act (Act) sets forth requirements for nursing facilities participating in the Medicare program and authorizes the Secretary of Health and Human Services to promulgate regulations implementing those statutory provisions.  Act § 1819.  The Secretary’s regulations are found at 42 C.F.R. Part 483.1   To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements.  To be in substantial compliance, a facility’s deficiencies may pose no greater risk to resident health and safety than “the potential for causing minimal harm.”  42 C.F.R. § 488.301. 

The Secretary contracts with state survey agencies to survey skilled nursing facilities in order to determine whether they are in substantial compliance.  Act § 1864(a); 42 C.F.R. § 488.20.  Each facility must be surveyed annually, with no more than fifteen months elapsing between surveys, and must be surveyed more often, if necessary, to ensure that identified deficiencies are corrected.  Act § 1819(g)(2)(A); 42 C.F.R. §§ 488.20(a); 488.308.  The state agency must also investigate all complaints.  Act § 1819(g)(4).

Here, on May 30, 2018, a surveyor from the New York State Department of Health (state agency) completed a survey of the facility.  Based on her findings, CMS determined that the facility was not in substantial compliance with:

• 42 C.F.R. § 483.45(g) (Tag F761, formerly F431) (pharmacy services – service consultation, labeling, and storage), cited at scope and severity level L

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(widespread substantial noncompliance that poses immediate jeopardy to resident health and safety).  CMS Ex. 1; CMS Ex. 2.

CMS determined that immediate jeopardy lasted for two days, from May 30 through 31, 2018.  CMS Ex. 2.

CMS subsequently determined that the facility returned to substantial compliance on July 26, 2018.  CMS Ex. 2 at 19-29; CMS Ex. 5.

CMS has imposed civil money penalties of $13,199 per day for two days of immediate jeopardy (May 30-31, 2018) and $505 per day for 55 days of substantial noncompliance that did not pose immediate jeopardy (June 1 through July 25, 2018), for a total penalty of $54,173 ($26,398 + $27,775 = $54,173).  CMS Ex. 2 at 20-29.

Petitioner appeals.  With its motion and brief (CMS Br.), CMS submits 21 exhibits (CMS Exs. 1-21).  With its brief in opposition to summary judgment (P. Br.), Petitioner submits 14 exhibits (P. Exs. 1-14).2

Informal dispute resolution (IDR).  Petitioner sought IDR through the state process.  42 C.F.R. § 488.331.  An IDR panel apparently recommended that the tag be deleted, and, initially, CMS agreed.  CMS Ex. 2 at 15-16.  However, CMS subsequently reopened its determination and explicitly rejected the IDR recommendation.  CMS Ex. 2 at 19-29.  In its hearing request, Petitioner challenged the reopening; during these proceedings, however, it appears to have abandoned that challenge.  Although it mentions the issue in passing, it has presented no argument.  See P. Br. at 5-6; Acknowledgment and Pre-hearing Order, Dkt. No. C-18-1332 at 3 ¶ 3 (ordering that the pre-hearing brief contain “any argument” the party intends to make); Acknowledgment and Consolidation Order, Dkt. No. C-19-144 (November 21, 2018) (consolidating the two appeals and ruling that the previously-issued order remained in effect).  In any event, it is well-settled that CMS may reopen an initial determination (42 C.F.R. § 498.30) and that CMS ultimately determines whether a facility is in substantial compliance and whether its deficiencies pose immediate jeopardy.  Act § 1819(h)(1)(2); Britthaven of Chapel Hill, DAB No. 2284 at 7-9 (2009). 

New issues.  CMS asserts that the facts presented here also establish that the facility was not in substantial compliance with two additional requirements:  42 C.F.R. § 483.45(f)(2) (Tag F333) (pharmacy services:  medication errors) and 42 C.F.R. § 483.10(g)(14) (Tag F157) (resident rights:  notification of changes) and asks that I consider the tags as new

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issues.  CMS Br. at 3 n.4; CMS Ex. 19 at 7-10 (Hill-O’Neill Decl. ¶¶ 19-27).3   The regulations specifically allow me, at the request of either party or on my own, to consider new issues, even if they arose after the hearing request was filed, so long as the opposing party has adequate notice and the opportunity to address the new issues.  42 C.F.R. § 498.56; Jennifer Matthew Nursing & Rehab. Ctr., DAB No. 2192 at 49-50 (2008).  CMS has provided such notice, and, in its brief, Petitioner addressed the new issues.  P. Br. at 5.4   I may therefore consider whether the facility’s deficiencies put it out of substantial compliance with sections 483.45(f)(2) and 483.10(g)(14), as well as section 483.45(g).  

Nevertheless, I decline to consider whether the facility was in substantial compliance with section 483.10(g)(14), which turns on a different (although related) set of facts.  The two deficiencies I affirm are based on the same set of facts and more than support the penalties imposed.  (In fact, as the following discussion shows, the penalty imposed is justified by the original citation alone.)  An administrative law judge need not consider all of the deficiencies cited, so long as the deficiencies she affirms support the penalties imposed.  Perry Cnty. Nursing Ctr. v. U.S. Dep’t of Health & Human Servs., 603 F. App’x 265, 271 (5th Cir. 2015) (agreeing that the regulations require ALJs to review only those findings that are material to the outcome of a case); Claiborne-Hughes Health Ctr. v. Sebelius, 609 F.3d 839, 847 (6th Cir. 2010); Rockcastle Health &  Rehab. Ctr., DAB No. 2891 at 23-24 (2018); Carrington Place of Muscatine, DAB No. 2321 at 20-21 (2010); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 6 n.5 (2010), aff’d, Senior Rehab. & Skilled Nursing Ctr. v. Health & Human Servs., 405 F. App’x 820 (5th Cir. 2010).

Issues

As a threshold matter, I consider whether summary judgment is appropriate.

On the merits, the issues are:

1.  From May 30 through July 25, 2018, was the facility in substantial compliance with Medicare program requirements;

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2.  If, on May 30 and 31, 2018, the facility was not in substantial compliance with Medicare program requirements, did its deficiencies then pose immediate jeopardy to resident health and safety; and

3.  If the facility was not in substantial compliance with Medicare program requirements, are the penalties imposed – $13,199 per day for two days and $505 per day for 55 days – reasonable?

Discussion

Summary judgment.  Summary judgment is appropriate if a case presents no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law.  Bartley Healthcare Nursing & Rehab., DAB No. 2539 at 3 (2013) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 322-25 (1986)); Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009), and cases cited therein.

The moving party may show the absence of a genuine factual dispute by presenting evidence so one-sided that it must prevail as a matter of law or by showing that the non-moving party has presented no evidence “sufficient to establish the existence of an element essential to [that party’s] case, and on which [that party] will bear the burden of proof at trial.”  Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs., 388 F.3d 168, 173 (6th Cir. 2004) (quoting Celotex Corp. v. Catrett, 477 U.S. at 322).  To avoid summary judgment, the non-moving party must then act affirmatively by tendering evidence of specific facts showing that a dispute exists.  Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986); Vandalia Park, DAB No. 1939 (2004); Lebanon Nursing & Rehab. Ctr., DAB No. 1918 (2004); Crestview Parke Care Ctr., DAB No. 1836 at 5 (2002). 

General denials do not satisfy a party’s burden to identify specific evidence demonstrating a material fact is in dispute.  Shah v. Azar, 920 F. 3d 987, 995 (5th Cir. 2019); Forsyth v. Barr, 19 F. 3d 1527, 1533 (5th Cir. 1994); Pearsall Nursing & Rehab., DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner “refers broadly to ‘the evidence presented in [its] response’” but “identifies no specific evidence relevant to the material facts . . . .”); Ill. Knights Templar, DAB No. 2274 at 4 (finding that the non-moving party must furnish admissible evidence of a dispute concerning a material fact); Livingston Care Ctr., DAB No. 1871 at 5 (2003), aff’d, Livingston Care Ctr. v. U.S. Dep’t of Health & Human Servs., 388 F.3d 168.  The non-moving party must also show more than “some metaphysical doubt as to the material facts.”  W. Tex. LTC Partners, Inc., DAB No. 2652 at 6 (2015), aff’d, W. Tex. LTC Partners, Inc. v. U.S. Dep’t. of Health & Human Servs., 843 F.3d 1043 (5th Cir. 2016); 1866ICPayday.com L.L.C., DAB No. 2289 at 3 (2009) (quoting Matsushita Elec. Indus. Co., 475 U.S. at 587).

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In examining the evidence for purposes of determining whether summary judgment is appropriate, I must draw all reasonable inferences in the light most favorable to the non-moving party.  Brightview Care Ctr., DAB No. 2132 at 2, 9 (2007); Livingston Care Ctr., 388 F.3d 172; Guardian Health Care Ctr., DAB No. 1943 at 8 (2004); see also Brightview, DAB No. 2132 at 10 (entry of summary judgment upheld where inferences and views of non-moving party are not reasonable).  However, drawing factual inferences in the light most favorable to the non-moving party does not require that I accept the non-moving party’s legal conclusions.  W. Tex. LTC Partners, DAB No. 2652 at 6-7, 14-15; cf. Guardian Health Care , DAB No. 1943 at 11 (“A dispute over the conclusion to be drawn from applying relevant legal criteria to undisputed facts does not preclude summary judgment if the record is sufficiently developed, and there is only one reasonable conclusion that can be drawn from those facts.”); see Green Valley Health Care & Rehab. Ctr., DAB No. 2947 at 8 (2019), quoting Johnson v. Perez, 823 F.3d, 701, 705 (D.C. Cir. 2016) (noting that a genuine factual dispute does not exist “when a putatively disputed body of evidentiary material could not, even assuming a sympathetic factfinder, reasonably support a finding crucial to the nonmoving party’s legal position.”). 

Summary judgment applied to administrative review in Medicare cases.  It is well-established that an administrative law judge is empowered to decide a case on a motion for summary judgment, without an evidentiary hearing.  Shah v. Azar, 920 F.3d 987, 996 (5th Cir. 2019) (citing Cedar Lake Nursing Home v. U.S. Dep’t of Health & Human Servs., 619 F.3d 453, 457 (5th Cir. 2010)); see Fal-Meridian, Inc. v. U.S. Dep’t of Health & Human Servs., 604 F.3d 445, 449 (7th Cir. 2010). 

There seems to be some confusion about applying such well-founded principles of civil litigation to these proceedings, with some suggesting that, to do so, denies a party a fundamental right.  In one succinct observation, Judge Posner of the Seventh Circuit Court of Appeals gave lie to such misconceptions:  “All it means for a decision to be based on a grant of summary judgment is that there are no issues that would benefit from being resolved in an evidentiary hearing.”  Fal-Meridian, 604 F.3d at 449 (emphasis added). 

Finally, deciding a case on summary judgment does not mean that it is decided without a hearing, and, in applying the principles of summary judgment to administrative proceedings, courts have been careful to avoid any suggestion that the case is decided without a hearing.  Throughout their decisions, they refer to deciding the case without an “oral hearing” or without an “evidentiary hearing.”  Although a case may be decided on summary judgment (or based on the written record), an administrative law judge, by considering the evidence and applying the law, has granted the petitioner a hearing, as required by sections 205(b) and 1866(h) of the Act.  See CNG Transmission Corp. v. FERC, 40 F.3d 1289, 1293 (D.C. Cir. 1994) (holding that a “paper hearing” satisfies statutory requirements for “notice and opportunity for hearing.”).

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As the following discussion shows, this case turns on purely legal issues:  whether the facility is responsible for the actions of its contractors; and whether putting the wrong label on a medication violates the requirement that drugs “be labeled in accordance with currently accepted professional principles.”  42 C.F.R. § 483.45(g).  

1.   CMS is entitled to summary judgment because the undisputed evidence establishes that the facility’s contract pharmacy mislabeled a resident’s medication, and, as a result, facility staff dispensed the wrong drug to one of its vulnerable residents, which put the facility out of substantial compliance with 42 C.F.R. § 483.45(f)(2) and (g).5

Program requirements:  42 C.F.R. § 483.45(f)(2) and (g) (Tags F333 and F761).  The facility must provide routine and emergency drugs and biologicals to its residents or obtain them under an agreement with an outside source.  42 C.F.R. § 483.45.  That agreement must specify that the facility assumes responsibility for obtaining services that meet the professional standards and principles that apply to professionals providing services.  42 C.F.R. § 483.70(g).

Among other requirements, the drugs and biologicals used in the facility must be labeled “in accordance with currently accepted professional principles.”  42 C.F.R. § 483.45(g).

The facility must also ensure that its residents are free of any significant medication errors.  42 C.F.R. § 483.45(f)(2).

Pharmacy services agreement.  The facility had an agreement with a pharmacy.  CMS Ex. 8.  By its terms, the pharmacy agreed to provide pharmacy services to the facility and its residents.  The pharmacy agreed (among other specifics) to label all products in accordance with applicable laws.  CMS Ex. 8 at 3.  The agreement included an indemnification clause, by which each party agreed to hold the other harmless “from and against any claim, cause of action, liability, damage, cost or expense” arising out of its breach of the agreement or “arising out of its negligent act or omission, or willful misconduct.”  CMS Ex. 8 at 12-13.

Facility pharmacy policies.  The pharmacy and the facility had in place written policies that governed drug labels.  According to one policy, in order to ensure accuracy, the “prepackager” of medications must prepackage them in a separate, designated area; work with only one medication at a time; and document on a daily log sheet all prepackaged medications.  The log sheet is to include:  the date prepackaged; the medication name, strength, and dosage; manufacturer; lot number and expiration date; number of packages;

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the initial or signature of the prepackager; and the signature of the responsible pharmacist.  CMS Ex. 7 at 1-2. 

The prepackaged units are inspected and released by a registered pharmacist.  The policy charges the inspecting pharmacist with ensuring that medications are packaged in accordance with the policy, paying particular attention to ensuring:  the correct medication; correct strength; proper expiration date; that the lot number matches the container and quality control log card; that each package contains the correct number of units; that the product is in an appropriate container; and that the seal is intact.  “A pharmacist’s signature on the quality control logs shall certify that the medication has been properly prepared, packaged, and labeled.”  CMS Ex. 7 at 2.

The facility had a separate policy for dispensing medications.  Its stated purpose is to ensure that the pharmacist “dispense[s] prescribed medication safely and accurately for the resident.”  CMS Ex. 7 at 3.  The policy for medication errors defines “medication error” as “any preventable event that may cause or lead to inappropriate medication use or customer harm” and includes product labeling.  Among the errors listed:  a label that differs from the medication ordered.  CMS Ex. 7 at 4.

Another policy calls for medication reviews whenever staff detect that a resident has experienced an acute change in condition.  Under the policy, the facility is required to designate a registered nurse (RN) to notify the pharmacist, when necessary, to identify medication as a potential cause of an acute change in a resident’s condition.  Within three days of receiving notification, the pharmacist must review the resident’s medications and identify, in a written report, any medication that has the potential to cause the change in condition.  The designated RN is then required to forward the report to appropriate medical staff and to the facility’s Director of Nursing (DON).  The resident’s medical provider must review the report and document, on its face, any changes to the resident’s medication regimen or the clinical rationale for not making a change.  The DON forwards the completed report to the facility’s medical director for review.  CMS Ex. 15 at 24.

Resident 1 (R1).  R1 was a 73-year-old man, initially admitted to the facility on November 25, 2015, suffering from a long list of ailments, including bipolar disorder, hydrocephalus, atherosclerotic heart disease, diabetes, diabetic peripheral angiopathy, and anemia.  He had muscle weakness and abnormalities of gait and mobility.  CMS Ex. 9 at 1-2; CMS Ex. 10 at 18, 19.  He did not have high blood pressure.  See CMS Ex. 9; CMS Ex. 10 at 18.

R1 underwent a quarterly assessment on March 7, 2018.  As part of that assessment, he scored 11 out of 15 on a brief interview for mental status (BIMS), which indicates a moderate cognitive impairment.  CMS Ex. 10 at 6.  His mental status was stable.  He had no difficulty focusing his attention; his thinking was neither disorganized nor incoherent; he experienced no altered level of consciousness.  CMS Ex. 10 at 7.  He experienced no

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hallucinations or delusions.  His behavior was unremarkable – exhibiting no physical or verbal aggression or other symptoms.  He did not reject evaluation or care.  CMS Ex. 10 at 10.

To control his bipolar disorder, his physician had prescribed lithium carbonate, 450 mg. at bedtime.  CMS Ex. 9 at 11, 12, 17.

R1’s care plan listed coronary artery disease and bipolar disorder among his problems.  The plan directed staff to administer his cardiac medications as ordered, and to monitor his blood pressure and report any abnormal readings to his physician; to monitor his labs and report the findings to his physician; and to monitor and report to his physician any signs or symptoms of coronary artery disease (chest pain or pressure, especially with activity, heartburn, nausea, vomiting, shortness of breath, excessive sweating).  CMS Ex. 9 at 9.

To address his bipolar disorder, R1’s care plan directed staff to:  administer his lithium and other antidepressant medications as ordered; monitor and report to his physician any signs and symptoms of depression unaltered by the antidepressant medications (sadness, irritability, anger, crying, slowed movement, agitation, disrupted sleep, fatigue, lethargy, changes in cognition, etc.); and observe the effectiveness and adverse effects of psychotropic medications.  CMS Ex. 9 at 11.  In a separate list, staff were instructed to:  monitor the resident for changes in mood or behavior; monitor for side effects of his medications; and observe the effectiveness of the medications.  CMS Ex. 9 at 12.

The mislabeled drug.  These facts are not disputed:

Responding to the facility’s resupply request, on April 30, 2018, the pharmacy supplied a blister pack of 30 pills; the pack was labeled lithium.  However, it did not contain lithium; it contained the anti-hypertensive, benazepril.  R1 did not have high blood pressure.  CMS Ex. 9 at 21, 23, 44, 45. 

From May 1 through 22, 2018, facility nurses administered the mislabeled benazepril to R1.  CMS Ex. 9 at 24.  Initially, staff reported no changes or minor changes in R1’s behavior, likely because it took that long for the stores of lithium to be eliminated from his body.6   CMS Ex. 11 at 25 (indicating, on May 1, that R1 was “doing well on current

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medication regimen”); CMS Ex. 11 at 23 (indicating, on May 2, no complaints or distress); CMS Ex. 11 at 21 (indicating, on May 7, “his mood is currently stable”).

By May 10, however, R1’s behavior had changed.  Nurses reported that he was “non-compliant,” which was a new behavior for him.  Progress notes indicate that he “was not quite his usual self” and “gave a hard time to take meds.”  CMS Ex. 11 at 18.  Thereafter, his condition further deteriorated.

• On May 13, staff reported that R1 was “more confused than usual” and that his blood pressure was lower than usual (87/60).  CMS Ex. 11 at 17.  Because he was also suffering from an infection, staff began to administer IV antibiotics.  CMS Ex. 11 at 17. 
• On May 14, staff reported that R1’s blood pressure “continues to run low” (118/74).  He was seen by a physician for his low blood pressure, elevated temperature, and weakness.  In an effort to increase his blood pressure, he was treated with IV fluids.  CMS Ex. 11 at 15-16.  
• On May 15, staff described the resident as confused.  He tried to hit the nurse’s hand to stop her from rehanging his IV fluids.  He kept repeating that he was “not a good person.”  His blood pressure was 94/63.  CMS Ex. 11 at 15.  Later that day, a  physician saw him for his low blood pressure, elevated temperature, and weakness.  CMS Ex. 11 at 14.  On May 16, a cardiac physician recommended discontinuing his potassium, with a follow-up in one to two months.  The resident was also to have consults with a neurologist and a urologist.  CMS Ex. 11 at 13-14.
• On May 17, staff reported that R1 continued to have behavioral issues and that his appetite was poor.  CMS Ex. 11 at 12.  His sister expressed her concern about his well-being, noting that “when he raises his hand, he is going to stop eating.”  She apparently asked that he be sent to the hospital, which the nurse discouraged, telling her that “the resident raising his hand up is not an indication for transfer to the hospital.”  CMS Ex. 11 at 12.
• The resident did not improve.  Later that night, staff described him as confused, “slow to respond and connect thought processes.”  Despite encouragement, he would take fluids only in small amounts.  He had to be “strongly encouraged” to take his evening medications.  He pushed the nurse who was providing care and then said he was sorry for doing so.  His blood pressure was 95/59.  CMS Ex. 11 at 11.

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• The following day, R1 continued to have behavioral issues.  He was “combative during care.”  CMS Ex. 11 at 10-11.
• Later that day, the facility’s dietician met with R1’s sister to discuss his “recent decline,” including low blood pressure and periods of confusion.  His appetite had been “poor to fair” for a week, according to the dietician’s note.  CMS Ex. 11 at 10.
• On May 19, R1’s blood pressure was down to 94/50.  CMS Ex. 11 at 10.
• On May 20, staff again described R1 as “agitated and combative.”  Staff were instructed to monitor his blood pressure and to notify his physician if it dropped significantly between his sitting and standing.  CMS Ex. 11 at 9-10.
• On May 22, R1’s blood pressure was 98/55.  CMS Ex. 11 at 6.  Staff reported that he had “brief episodes of aggression.”  He gestured that he would hit the nurse dispensing his medications.  He then apologized, saying that he didn’t know why he had done that.  CMS Ex. 11 at 9.  Later that morning, he spit out his medications.  Id.
  
  Elsewhere, staff reported that he was “agitated and combative with staff during care.”  He refused his medications and hit the nurse’s hands, throwing the medications on the floor.  “Resident attempts to hit this writer then apologize[d] and voiced, ‘I don’t know what’s happening to me.’”  CMS Ex. 11 at 6-7.
• By that time, the results of blood work, drawn on May 18, were available.  R1 had “undetectable” levels of lithium in his blood.  CMS Ex. 9 at 37, 39.  His nurse practitioner ordered 450 mg. of lithium immediately, followed by 300 mg. per day for four days.  His lithium levels were to be drawn the following day (May 23) and again on May 26 and May 30.  CMS Ex. 11 at 8.  The nurse practitioner reiterated staff reports of R1 exhibiting “abnormal behaviors.  He strikes [without] notice and apologizes afterward.”  This was a marked change; he was normally a “very pleasant individual.”  CMS Ex. 11 at 5, 7.
• In a note, dated May 23, the facility’s social worker reported R1’s periods of agitation, “possibly related to depression.”  CMS Ex. 11 at 5.

On May 23, 2018, R1’s psychiatrist examined R1 and noted his change in status, characterized by his poor appetite, withdrawn affect, sparse language, and depressed and “clearly decompensated” mood.  CMS Ex. 9 at 42.

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Upon reviewing R1’s (nonexistent) lithium levels, R1’s psychiatrist was “skeptical” that the tablet that was being administered to him was lithium.  The psychiatrist examined the tablets and noted that he had never seen a lithium tablet that looked like the one administered to R1 (a gray pill with the letter “S” and number “343” on each side).  CMS Ex. 11 at 5; see CMS Ex. 9 at 45.  The psychiatrist initially recommended that R1 be hospitalized to stabilize his psychiatric condition and ordered that lithium be administered immediately.  CMS Ex. 9 at 17, 43; see CMS Ex. 11 at 5.

R1’s nurse practitioner investigated and discovered that the pills the facility administered were, in fact, benazepril/lotensin, an anti-hypertensive.  CMS Ex. 11 at 5.  She reported her findings to the facility’s medical director and asked that he start an investigation.  She also called the nursing department and ordered them to stop administering the erroneous medication.  CMS Ex. 11 at 5.

By May 23, the facility had started administering actual lithium to R1.  Nevertheless, because it takes time to achieve therapeutic blood levels, the resident continued his aggressive behavior.  On the morning of May 24, staff were unable to reinsert his IV because he was too combative.  CMS Ex. 11 at 4.  His nurse practitioner described his disturbing behavior:

Patient is restless, confused, aggressive, impulsive, combative, clingy, and afraid.  He states to staff, “[D]on’t leave me.”  He sits on the bed but lunges at people near him.  He pulled out his IVL this morning and he had to be coaxed to take some of his medications with applesauce.

CMS Ex. 11 at 3. 

At 4:28 p.m. on May 24, R1’s blood pressure was 77/44.  Because staff could not bring it under control, he was transferred to the hospital for further evaluation.  CMS Ex. 11 at 1-2; CMS Ex. 12 at 2-8.

Thus, the undisputed evidence establishes that R1’s medication was mislabeled, and, from May 1 through 22, 2018, facility staff gave him the wrong medication.  CMS Ex. 9 at 44-45.  As a result, his behavior underwent a dramatic change; he exhibited the significant symptoms of depression listed in his care plan – sadness, irritability, anger, crying, slowed movement, agitation, disrupted sleep, fatigue, lethargy, and changes in cognition.  CMS Ex. 9 at 11.  Equally disturbing, he experienced serious fluctuations in his blood pressure because he was administered the mislabeled anti-hypertensive.  CMS Ex. 11 at 1; CMS Ex. 12 at 2-8.

A drug used in the facility – and administered daily for three weeks – was not labeled in accordance with professional principles, putting the facility out of substantial compliance

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with section 483.45(g).  The facility did not ensure that R1 was free of any significant medication errors, which put it out of substantial compliance with 42 C.F.R. § 483.45(f)(2). 

Petitioner’s arguments.  Petitioner acknowledges, as it must, that the drug packet containing benazepril was labeled lithium, which leads to the inescapable conclusion that the drug was not properly labeled.  See P. Br. at 1.  Remarkably, Petitioner argues that the label was, in fact, correct.  Petitioner characterizes the mislabeling as a “packaging error” rather than a labeling error.  P. Br. at 1, 9-11.  In Petitioner’s view, but for its being placed on the wrong drug, the label was perfect:  consistent with the physician order, it identified a drug, lithium, and included “the appropriate accessory and cautionary instructions, as well as the expiration date, which, by its plain language, is all the regulation requires.”  P. Br. at 2.

I reject this argument.  Nothing is more basic to proper labeling than correctly identifying the drug that is labeled.  Here, every bit of information on the drug label was wrong.  I am aware of no professional principle – and obviously there is none – that sanctions putting the completely wrong label on a drug.  In the State Operations Manual, app. PP, Tag F761 (Rev. 173, eff. Nov. 28, 2017), CMS cites an example that illustrates this obvious fact and underscores that putting the wrong label on a medication violates section 483.45(g):

As a result of an incorrect label on the package, staff administered the wrong medication or wrong dose(s) of a medication (e.g., anticonvulsant, antihyperglycemic, benzodiazepine) with a potential for clinically significant adverse consequences, which resulted in, or had the potential for, serious harm or death (e.g., toxic levels of the medication, unresponsiveness, uncontrolled seizures).

CMS Ex. 6 at 4.7

Nevertheless, Petitioner argues that requiring a drug’s label to identify correctly the packaged drug “would result in an expansion of the regulation beyond its plain meaning” and would therefore render the regulation meaningless:  “CMS could simply hold [skilled nursing facilities] responsible for all medication errors[,] without regard to whether a regulation was actually violated.”  P. Br. at 2.  Again, I am frankly baffled by Petitioner’s argument.  Requiring that the label on a drug accurately identify the drug is a minimal requirement, plainly spelled out in the regulation, 42 C.F.R. § 483.45(g).  Moreover, except where they are of no consequence, the regulations, in fact, hold facilities

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responsible for medication errors.  See, e.g., 42 C.F.R. § 483.45(a) (requiring the facility to “assure” that drugs be dispensed accurately to meet the needs of each resident); 42 C.F.R. § 483.45(f) (requiring that the facility ensure that medication error rates are not 5 percent or greater and that residents are free of any significant medication errors); and 42 C.F.R. § 483.45(g) (requiring that drugs be labeled properly).

Petitioner also blames its contract pharmacy for the error and argues that the facility is not responsible for errors made by its contractors.  The regulations say otherwise.  The language of section 483.45(g) makes it plain that the facility is responsible for drug labeling.  See 56 Fed. Reg. 48,826, 48,860 (Sept. 26, 1991) (explaining that the language of the regulation imposes labeling requirements on the facility); State Operations Manual, app. PP, Tag F761 (CMS Ex. 6 at 1) (explaining, pursuant to section 483.45(g), that the facility, in coordination with the pharmacist, provides accurate labeling).  Use of an outside resource for professional services does not relieve the facility of its obligation.  42 C.F.R. § 483.21(b)(3)(i).

In Maysville Nursing & Rehab. Facility, DAB No. 2317 (2010), the Departmental Appeals Board rejected the facility’s argument that it was not responsible for the mistakes of its contract pharmacist.  The Board reiterated its long-standing position that the facility is responsible for the actions of its licensed staff, ruling that the facility “cannot disown the consequences of the inadequacy of the care provided by the simple expedient of pointing the finger at [staff failings] since [staff is] the agent of [the] employer[,] empowered to make and carry out daily care decisions.”  DAB No. 2317 at 13 (quoting Emerald Oaks, DAB No. 1800 at 7 n.3 (2001)).  The Board noted that the facility executes the provider agreement and provides services “of the quality mandated by the participation requirements.”  Id.

The Board then ruled that “this rationale [is] no less applicable here[,] even if [the facility] hired the pharmacist as a consultant rather that an employee.”  The facility is required to provide the pharmacy services to ensure that residents receive quality care.  Maysville, DAB No. 2317 at 14.

Finally, citing section 483.75(h)(2)(i) – which is now section 483.21(b)(3)(i)) – the Board observed that the regulations specifically make a facility responsible for the quality of the services provided by outside resources, which would include the services of a contract pharmacist.  (“The services provided or arranged by the facility, as outlined by the comprehensive care plan, must . . . [m]eet professional standards of quality.”).  Id.

The nurse’s statement.  CMS enhances its case with an additional assertion that the medication nurse recognized a potential problem with the pills she was dispensing.  As the psychiatrist did later, she noticed that the pills differed from the lithium tablets she had been dispensing.  But she reported no concerns about the changed appearance of the medication, even after R1’s depressive symptoms manifested themselves.  She told the

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surveyor that she didn’t know what to do if she noticed a change in the appearance of a medication, so she did nothing.  CMS Ex. 13 at 4.  CMS argues that she should have followed a facility policy that directs staff administering medications to refer to Drugs.com when unfamiliar with the pharmacology of a medication.  CMS Ex. 15 at 3; see CMS Ex. 13 at 8 (Petitioner’s DON opining that “its [sic] just a good practice” for a nurse to check if she sees something different with a medication).

Although Petitioner presents no actual evidence to establish a dispute about this, it attacks the reliability of CMS’s evidence, particularly the competence and veracity of its own staff, questioning the employee’s “statements, credibility, truthfulness and knowledge.”  P. Br. at 22.  To the extent that Petitioner’s argument raises a dispute of fact, it is not material.8   The undisputed facts – that R1’s medication was mislabeled and that staff gave him the wrong medication – resolve this case, without regard to the purported knowledge and inaction of the medications nurse. 

2.   The undisputed evidence establishes that CMS’s determination that the facility’s deficiencies posed immediate jeopardy to resident health and safety is not clearly erroneous.

Immediate jeopardy.  Immediate jeopardy exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident.”  42 C.F.R. § 488.301.  CMS’s determination as to the level of a facility’s noncompliance (which would include an immediate jeopardy finding) must be upheld unless it is “clearly erroneous.”  42 C.F.R. § 498.60(c).  The Board has observed repeatedly that the “clearly erroneous” standard imposes on facilities a “heavy burden” to show no immediate jeopardy and has sustained determinations of immediate jeopardy where CMS presented evidence “from which ‘[o]ne could reasonably conclude’ that immediate jeopardy exists.”  Florence Park Care Ctr., DAB No. 1931 at 27-28 (2004) (citing Koester Pavilion, DAB No. 1750 (2000)); Daughters of Miriam Ctr., DAB No. 2067 at 7, 9 (2007).

Once CMS presents evidence supporting a finding of substantial noncompliance, it need not offer evidence to support its immediate jeopardy determination.  The burden is on the facility to show that CMS’s determination is clearly erroneous.  Grace Healthcare of Benton, DAB No. 2189 at 13 (2008) (citing Liberty Commons Nursing & Rehab Ctr.- Johnston, DAB No. 2031 at 17-18, aff’d, Liberty Commons Nursing & Rehab Ctr. – Johnston v. Leavitt, 241 F. App’x 76 (4th Cir. 2007)).  The harm or threatened harm is presumed to be serious, and the facility has the burden of establishing that the harm or threatened harm “did not meet any reasonable definition of ‘serious.’”  Maysville Nursing

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& Rehab., DAB No. 2874 at 21 (2018) (quoting Libertywood Nursing Ctr., DAB No. 2433 at 18 (2011), aff’d, Libertywood Nursing Ctr. v. Sebelius, 512 F. App’x 285 (4th  Cir. 2013)).

Petitioner argues that the immediate jeopardy determination is not reasonable because the facts do not establish that its noncompliance caused or was likely to cause serious harm, and, in any event, the facility should not be held accountable for its pharmacist’s errors.  P. Br. at 24-25.  As discussed above, it is well-settled that the facility is responsible for the actions of its contractors.

Moreover, this is the type of situation the State Operations Manual describes to illustrate an example of immediate jeopardy under section 483.45.  As a result of an incorrect label on the medication package, staff administered the wrong medication, which had “a potential for clinically significant adverse consequences,” and resulted in, or had the potential for, serious harm.  CMS Ex. 6 at 4.  That R1 suffered serious harm – emotionally and physically – is well-documented and not seriously disputed.  His mental health deteriorated, leaving him depressed, lost, and even more confused.  CMS Ex. 11 at 3-21; CMS Ex. 9 at 42; CMS Ex. 17.  Physically, he experienced dramatic and dangerous fluctuations in his blood pressure, which staff initially treated by administering IV fluids.  When they ultimately could not control the fluctuations, the resident had to be hospitalized.  CMS Ex. 11 at 1; CMS Ex. 12 at 2-8. 

To the extent that any of Petitioner’s witnesses opine that R1 was not significantly affected by the medication error, I need not, for purposes of summary judgment, consider that such opinions create a genuine factual dispute.  The evidence of harm is so one-sided that it could not reasonably support the finding that R1 was not seriously harmed, even by a factfinder sympathetic to Petitioner’s position.  See Green Valley Healthcare & Rehab. Ctr., DAB No. 2947 at 8 (2019) (quoting Johnson v. Perez, 823 F. 3d, 701, 705 (D.C. Cir. 2016)).  Further, where opinion testimony “is wholly at odds with what is shown unambiguously on the face of the [facility’s] documents,” it is not sufficient to raise a genuine dispute of fact precluding summary judgment; no rational trier of fact would be persuaded by expert testimony if it is contradicted by the facility’s documents on their face.  Bartley, DAB No. 2539 at 8.

In any event, the regulation does not require actual harm, but the likelihood of serious injury or harm.  Administering an anti-hypertensive to someone with normal or low blood pressure is obviously likely to cause serious harm; denying someone suffering from bipolar disorder the mood-stabilizing medication he requires is also likely to cause serious harm.  More generally, mislabeling a medication and administering the wrong medication to virtually any vulnerable long-term-care resident is likely to cause serious harm. 

CMS’s immediate jeopardy determination is therefore not clearly erroneous.

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3.   The undisputed evidence establishes that the penalties imposed are reasonable.

To determine whether a civil money penalty is reasonable, I apply the factors listed in 42 C.F.R. § 488.438(f):  (1) the facility’s history of noncompliance; (2) the facility’s financial condition; (3) factors specified in 42 C.F.R. § 488.404; and (4) the facility’s degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort or safety.  The absence of culpability is not a mitigating factor.  The factors in 42 C.F.R. § 488.404 include:  (1) the scope and severity of the deficiency; (2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and (3) the facility’s prior history of noncompliance in general and specifically with reference to the cited deficiencies.

I consider whether the evidence supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found, and in light of the section 488.438(f) factors.  I am neither bound to defer to CMS’s factual assertions nor free to make a wholly independent choice of remedies without regard for CMS’s discretion.  Barn Hill Care Ctr., DAB No. 1848 at 21 (2002); Cmty. Nursing Home, DAB No. 1807 at 22 et seq. (2002); Emerald Oaks, DAB No. 1800 at 9 ; CarePlex of Silver Spring, DAB No. 1638 at 8 (1999).

Here, CMS imposes penalties of $13,199 per day for two days of immediate jeopardy, which is in the mid-range ($6,394 to $20,965), and $505 per day for 55 days of substantial noncompliance that did not pose immediate jeopardy, which is in the very low range ($105 to $6,289).  42 C.F.R. §§ 488.408(d); 488.438; 45 C.F.R. § 102.3 (2017); 82 Fed. Reg. 9174, 9182-83 (Feb. 3, 2017).9

Except to argue that it was in substantial compliance and, thus, not subject to any penalty, Petitioner has not discussed the reasonableness of the penalty.

Applying the relevant factors here, these penalties are reasonable.

The facility history is not perfect.  Since 2006, it has consistently been out of substantial compliance during its annual recertification surveys, as well as during intervening complaint investigations, with deficiencies cited at scope and severity levels D (isolated instance of substantial noncompliance that causes no actual harm with the potential for more than minimal harm) and E (pattern of substantial noncompliance that causes no

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actual harm with the potential for more than minimal harm).  CMS Ex. 16.  Among the deficiencies cited:

• The facility was twice out of substantial compliance with pharmacy services because of medication errors (March 23, 2012, cited at scope and severity level E and October 22, 2007, cited at scope and severity level D).  CMS Ex. 16 at 3, 4.
• The facility was cited five times for failing to meet professional standards of quality (March 31, 2015; April 25, 2014; April 13, 2011; October 22, 2007; and January 24, 2006) at scope and severity level D.  CMS Ex. 16 at 2, 3, 4, 5.
• The facility was cited six times for various quality-of-care deficiencies (April 14, 2017; March 21, 2016; March 31, 2015; April 25, 2014; July 2, 2013; and January 20, 2009) at scope and severity level D.  CMS Ex. 16 at 1, 2, 3, 4.

Over the years, other deficiencies were cited in the areas of food services, nursing, infection control, housekeeping and maintenance, lab services, and failing to consult promptly a physician regarding a resident’s change in condition.  CMS Ex. 16.

Petitioner does not claim that its financial condition affects its ability to pay the penalties.

With respect to the remaining factors, a very serious error was made here, with significant negative repercussions for a vulnerable resident.  As discussed above, the facility is accountable for the error.

For these reasons, I find that the amounts of the CMPs are reasonable.

Conclusion

The material facts in this case are undisputed, and the case turns on purely legal issues.

The undisputed facts establish that, from May 30 through July 25, 2018, the facility was not in substantial compliance with 42 C.F.R. §§ 483.45(f)(2) and (g).  On May 30 and 31, 2018, its deficiencies posed immediate jeopardy to resident health and safety.  The penalties imposed – $13,199 per day for two days of immediate jeopardy and $505 per day for 55 days of substantial noncompliance that did not pose immediate jeopardy – are not clearly erroneous.  I therefore grant CMS’s motion for summary judgment.

1. Although the regulations governing long-term care facilities have been revised, their substance (much of which is also statutory) has not changed, so cases decided prior to the revisions remain valid.  81 Fed. Reg. 68,688 (Oct. 4, 2016); 82 Fed. Reg. 32,256 (July 13, 2017).
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2. CMS has objected to several of Petitioner’s proffered exhibits.  Because I decide this case on summary judgment, I need not rule on those objections.  Lilia Gorovits, M.D., P.C., DAB No. 2985 (2020) at 3 n.4; Univ. of Tex. MD Anderson Cancer Ctr., DAB No. 2927 at 18 (2019); Illinois Knights Templar Home, DAB No. 2274 at 6-7 (2009).
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3. On pages 9 and 10 of CMS Ex. 19, the paragraphs following paragraph 25 are not numbered correctly.  What should be paragraphs 26 through 29 are incorrectly numbered paragraphs 18 through 21.  My citations are to the corrected numbering.
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4. Petitioner correctly asserts that Tag F333 addresses medication errors and that Tag F157 addresses notification of changes.  However, Petitioner cites to the old regulations, which, as noted above, were amended, effective November 28, 2016.  See 81 Fed. Reg. 68,688.
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5. My findings of fact/conclusions of law are set forth, in italics and bold, in the discussion captions of this decision.
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6. The half-life of a drug is the time it takes for the amount of it in the body to be reduced by half.  How long this takes depends on how the body processes and eliminates the drug.  It can vary from a few hours to a few days.  The elimination half-life of lithium is about 18-24 hours; however, it is “considerably longer in the elderly because of the age-related decrease in glomerular filtration rate,” i.e., how well the kidneys are working.  According to at least one study, duration of treatment may also affect the half-life of lithium.  For those just starting treatment, the half-life was 1.3 days; for those treated for over a year, it was 2.4 days.  CMS Ex. 18 at 5-6.  It seems that R1 had been treated with lithium for years.  See CMS Ex. 12 at 9; CMS Ex. 13 at 3-4.
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7. In fact, CMS considered this level of noncompliance to pose immediate jeopardy.  See discussion, below.
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8. Petitioner has asked that the nurse be subpoenaed for cross-examination.  Because her testimony is not material, it is not reasonably necessary for the full presentation of Petitioner’s case.  See 42 C.F.R. §§ 498.58(a); 498.60(b).
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9. Penalties are inflation-adjusted and change annually.  The amount is determined as of the date the penalty is assessed, in this case, on June 28, 2018.  See CMS Ex. 2 at 1; 82 Fed. Reg. at 9182-83.
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