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                              Park Plaza LTC Partners, Inc., DAB CR5493 (2019)
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Park Plaza LTC Partners, Inc., DAB CR5493 (2019)








  
  
    

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





Park Plaza LTC Partners, Inc.,
	(CCN: 675982),
	Petitioner,
v.
Centers for Medicare & Medicaid Services
Docket No. C-17-718Decision No. CR5493December 13, 2019

        
              
    

      DECISION
Petitioner, Park Plaza LTC Partners, Inc., is a long-term care facility located in San Angelo, Texas, that participates in the Medicare program. One of its employees – a licensed vocational nurse – mistakenly discontinued a resident’s medication order for a thyroid-replacement drug, and no one noticed. The affected resident, who suffered from severe hypothyroidism, went 44 days without her medication. Finally, while she was hospitalized, blood tests revealed severe hypothyroidism, and physicians diagnosed a myxedema coma.
The Texas state survey agency investigated, and, based on its survey, completed March 1, 2017, the Centers for Medicare & Medicaid Services (CMS) determined that the facility was not in substantial compliance with Medicare requirements, including those that govern pharmacy services and medication errors. CMS has imposed civil money penalties (CMPs) of $2,875 per day for 44 days and $305 per day for 34 days of substantial noncompliance ($136,870 total).
Petitioner appeals. CMS has moved for summary judgment, which Petitioner opposes.
**Page 2**
I grant CMS’s motion.
The undisputed evidence establishes that the facility was not in substantial compliance with the regulations governing pharmacy services and administration, and that the penalties imposed ($2,875 and $305 per day) 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. 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).
In this case, a surveyor from the Texas Department of Aging and Disability Services went to the facility to investigate a complaint. She completed her investigation on March 1, 2017. CMS Ex. 1 at 1; CMS Ex. 3. Based on her findings, CMS determined that the facility did not comply substantially with two program requirements:
42 C.F.R. § 483.45(f)(2) (Tag F333 – pharmacy services: medication errors) at scope and severity level H (pattern of substantial noncompliance that causes actual harm but does not pose immediate jeopardy to resident health and safety); and
	42 C.F.R. § 483.70(i)(1) and (5) (Tag F514 – administration: medical records) at scope and severity level E (pattern of substantial noncompliance that causes no actual harm with the potential for more than minimal harm).CMS Ex. 1 at 1; CMS Ex. 3.
Thereafter, CMS determined that the facility returned to substantial compliance on March 2, 2017. CMS has imposed against the facility penalties of $2,875 per day for 44 days (December 14, 2016 – January 26, 2017) and $305 per day for 34 days (January 27 – March 1, 2017) of substantial noncompliance (total $136,870). CMS Ex. 1 at 9.
**Page 3**
Petitioner appealed, and CMS has moved for summary judgment. Petitioner opposes. In addition to its motion for summary judgment (CMS MSJ), CMS submitted a prehearing brief (CMS Br.) and eleven exhibits (CMS Exs. 1-11). Petitioner submitted its own prehearing brief (P. Br.), its memorandum in opposition to summary judgment (P. Opp.), and 13 exhibits (P. Exs. 2, 4-15).
Issues
As a threshold matter, I consider whether summary judgment is appropriate.
On the merits, the issues are:
From December 14, 2016, through March 1, 2017, was the facility in substantial compliance with 42 C.F.R. §§ 483.45(f)(2) and 483.70(i)(1) and (5);
	If the facility was not then in substantial compliance with program requirements, are the penalties imposed – $2,875 per day for 44 days and $305 per day for 34 days – reasonable.**Scope and severity**. Petitioner also challenges the scope-and-severity determinations, which I have no authority to review. The regulations authorize review of a scope and severity determination if: (1) a successful challenge would affect the range of the CMP; or (2) CMS has made a finding of substandard quality of care that results in the loss of approval of the facility’s nurse aide training program. 42 C.F.R. §§ 498.3(b)(14), 498.3(d)(10); *N. Las Vegas Care Ctr.*, DAB No. 2946 at 10-11 (2019). Here, the CMP range would not change if I altered the scope and severity finding because the penalties CMS imposed are already in the lower of the two CMP ranges. 42 C.F.R. § 488.438(a)(1). Petitioner has not claimed that it has a nurse aide training program, but, assuming it does, so long CMS imposes a penalty of $10,483 or more (as it has here) the state cannot approve the program. So the facility loses its approval without regard to the scope and severity finding. Act § 1819(f)(2)(B); 42 C.F.R. § 483.151(b)(2)(iv); 45 C.F.R. § 102.3 (table).
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.
**Page 4**
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. Dep’t of Health & Human Servs.*, 388 F.3d 168, 173 (6th Cir. 2004) (quoting *Celotex*, 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); *see also Vandalia Park*, DAB No. 1939 (2004); *Lebanon Nursing & Rehab. Ctr.*, DAB No. 1918 (2004). The non-moving party may not simply rely on denials, but must furnish admissible evidence of a dispute concerning a material fact. *Ill. Knights Templar*, DAB No. 2274 at 4; *Livingston Care Ctr*., DAB No. 1871 at 5 (2003). In doing so, the non-moving party must 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*, 475 U.S. at 587).
In examining the evidence for purposes of determining the appropriateness of summary judgment, 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); *Guardian Health Care Ctr.*, DAB No. 1943 at 8 (2004); *see Livingston Care Ctr.*, 388 F.3d at 172-73; *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, Inc.*, DAB No. 2652 at 6-7, 14-15; *cf. Guardian Health Care Ctr.*, 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.”).
**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, 449-50 (7th Cir. 2010).1
 Nevertheless, there seems to be
**Page 5**
some confusion about applying such well-founded principles of civil litigation to these proceedings, with some ill-informed advocates 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 misapprehensions: “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). Thus, because the petitioner/nursing home did not tender evidence that, if believed, would show its substantial compliance, the Seventh Circuit sustained the ALJ’s granting summary judgment in CMS’s favor. *Id.* at 451.
Here, CMS has come forward with evidence – primarily the facility’s own documents and uncontroverted hospital records – establishing facts showing that the facility was not in substantial compliance with sections 483.45(f)(2) and 483.70(i)(1). For its part, Petitioner has not come forward with any admissible evidence establishing a dispute over the objective facts. Instead, it characterizes legal conclusions as disputes of fact and asks me to ignore irrefutable evidence in order to draw unreasonable inferences based on witness speculation. Speculation and unsubstantiated assertions do not satisfy a party’s burden to identify *specific* evidence demonstrating a material fact in dispute. *Shah v. Azar*, 920 F.3d at 995-96; *Pearsall Nursing & Rehab. Ctr. – North*, DAB No. 2692 at 7 (2016) (affirming summary judgment where Petitioner “refer[red] broadly to ‘the evidence presented in [its] response’” but “identifie[d] no specific evidence relevant to the material facts”); *Forsyth v. Barr*, 19 F.3d 1527, 1533 (5th Cir. 1994).
As the following discussion shows, no issue here would benefit from being resolved in an evidentiary hearing. I rely solely on the unchallenged documentary evidence, not on CMS witness testimony. And I accept, for purposes of summary judgment, the factual claims (although not the conclusions) made by Petitioner’s witnesses. For Petitioner to prevail, I would have to agree that the facility’s long-term and unjustified failure to administer a resident’s thyroid medication does not constitute a significant medication error and is not likely to cause more than minimal harm. Because I cannot reach that conclusion, Petitioner simply cannot prevail.
**Page 6**
***CMS is entitled to summary judgment because the undisputed evidence establishes that, for 44 days, facility staff did not administer a resident’s prescribed medication, disregarding a physician’s order and the resident’s care plan. As a result, the facility was not in substantial compliance with 42 C.F.R. §§ 483.45(f)(2) and 483.70(i)(1).2*****Program requirement: 42 C.F.R. § 483.45(f)(2) (Tag F333)**. The facility must provide routine and emergency drugs to its residents and must ensure that its residents are free of any significant medication errors.
**Program requirement: 42 C.F.R. § 483.70(i)(1) and (5) (Tag F514)**. The facility must also be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psycho-social well-being of each resident. Among other specific requirements, the facility must, in accordance with accepted professional standards and practices, maintain medical records on each resident that are complete, accurately documented, readily accessible, and systematically organized. Each medical record must contain: sufficient information to identify the resident; a record of the resident’s assessments; the resident’s comprehensive care plan and services provided; the results of any preadmission screening and resident review evaluations and determinations conducted by the state; the physician’s, nurse’s, and other licensed professional’s progress notes; and laboratory, radiology, and other diagnostic services reports.
**Resident 2 (R2)**. R2 was an 84-year-old woman when she was admitted to the facility on February 8, 2016. She suffered from a long list of ailments, including congestive heart failure, glaucoma, muscle wasting, dysphagia, peripheral vascular disease, diabetes, and hypothyroidism. CMS Ex. 4 at 1, 3, 141-142. To treat her hypothyroidism, her physician prescribed a thyroid-replacement medication, Levothyroxine, 125 mcg (micrograms) daily. CMS Ex. 4 at 8, 50, 68, 74.
R2’s care plan, dated December 26, 2016, identified her hypothyroidism as an issue of concern and directed staff to “[g]ive thyroid replacement therapy as ordered,” specifically Levothyroxine, daily. Staff were also directed to monitor and document side effects and the effectiveness of the drug. The plan listed signs and symptoms of hypothyroidism: rapid pulse, weight loss, fatigue, heat intolerance, increased perspiration, anxiety, restlessness, tremor, insomnia, palpitations, fever, goiter or enlargement of thyroid gland, and hair/skin/nail texture changes. Staff were to monitor for these symptoms, document them, and report them to the resident’s physician. The plan’s stated goals were to: 1) keep the resident free from the signs and symptoms of hypothyroidism; 2) be sure that *she was compliant with hormone replacement therapy*; and 3) have her thyroid function
**Page 7**
tests within normal limits through the review date. The plan listed January 2, 2017, as the “target date” and January 12, 2017, as the “revision date.” CMS Ex. 4 at 110.
At the time they developed the care plan, neither its drafters nor anyone else noticed that facility staff had not been administering R2’s thyroid medication for two weeks. On December 13, 2016, one of the facility’s nurses erroneously discontinued the medication. CMS Ex. 4 at 8, 22, 87; P. Br. at 3 (admitting that an order for Levothyroxine “was inadvertently discontinued”). Staff did not administer the prescribed drug for 44 days. *See* CMS Ex. 4 at 25-37 (showing that the drug was administered from December 8-13, 2016, but not thereafter).
R2 began to show symptoms of decreased cognition, and preliminary lab results showed that she had a urinary tract infection. CMS Ex. 4 at 6; P. Ex. 4 at 1-2. On January 26, 2017, at her family’s insistence, R2 was transferred to the hospital. CMS Ex. 4 at 6, 12, 23, 87. Upon her admission, she was diagnosed with acute renal failure and “multiple other items to . . . qualify for sepsis.” CMS Ex. 5 at 3-5. After additional blood work, the hospital diagnosed severe hypothyroidism, untreated, and myxedema coma (severe hypothyroidism leading to decreased mental status, hypothermia, and other symptoms). CMS Ex. 5 at 8, 18, 21, 31, 42. The hospital immediately reinstated the thyroid medication, and hospital physicians emphasized and “re-emphasized” how important it was for her to take it. CMS Ex. 5 at 26, 56.
R2 was thus a very ill woman, who suffered from multiple serious disorders, including hypothyroidism. Unquestionably, depriving her, for a prolonged period, of her much-needed thyroid medication was a significant medication error that posed the potential for causing (and likely did cause) more than minimal harm.
Moreover, in failing to administer medications as ordered, facility staff disregarded the resident’s care plan. According to the plan, nursing staff were responsible for ensuring that R2 received her thyroid-replacement medication, and they were supposed to be monitoring and documenting its effects. Either staff did not review the plan, or they reviewed it but chose to ignore it.3
 Had anyone paid attention, he/she would have known that R2 needed thyroid medication even though her physician order for it had been deleted. And if the plan’s “target date” and “revision date” had any meaning, staff would have reviewed R2’s thyroid medication situation on January 2 and January 12, detecting the error well before the hospital discovered it.
**Page 8**
These undisputed facts show that the facility’s problem went beyond the failings of its nursing staff. As part of the pharmacy-services regulation, a licensed pharmacist is supposed to review, at least monthly, each resident’s drug regimen, including the resident’s medical chart, and to report and document any irregularities. 42 C.F.R. § 483.45(b). As Petitioner tacitly admits, the pharmacist was not adequately performing his job. P. Opp. at 9 (conceding that, “when the facility’s pharmacy consultant reviewed drug records for December, he did not catch this mistake”).
Thus, the safeguards that are supposed to be in place to ensure that facility residents receive proper medication were not working, which resulted in a significant medication error and put the facility out of substantial compliance with 42 C.F.R. § 483.45(f)(2).
Because staff erroneously deleted R2’s medication order, her medical record was neither complete nor accurate, putting the facility out of substantial compliance with 42 C.F.R. § 483.70(i).
Petitioner, however, argues that two “inherently factual determinations” preclude summary judgment: 1) what led to the medication error; and 2) what effect, if any, the error had on R2. Pet. Opp. at 7. Petitioner’s argument fails for two reasons: 1) the “inherently factual determinations” are not in serious dispute; and 2) to the extent that any underlying fact is in dispute, that fact is not material.
First, the cause of the medication error is not in dispute. Although Petitioner and its witnesses ambiguously describe the problem as a “computer error,” facility records leave no doubt – and Petitioner produces no evidence to suggest otherwise – that the underlying “error” was a nurse who inadvertently discontinued the drug, while she correctly discontinued two other orders. CMS Ex. 4 at 8, 22, 87; P. Ex. 5 at 3-7; P. Ex. 12 at 3 (Kofron Decl.); P. Ex. 13 at 3 (Duffley Decl.). But the cause of the medication error is not material. Petitioner is as responsible for ensuring that its computer system is working properly and not causing significant medication errors as it is for ensuring that its staff is not causing errors and ensuring that any errors are detected and remedied. The critical factor here is that the error occurred and continued undetected over a lengthy period.
Second, although Petitioner attempts to create a dispute regarding the effect of the medication error (which is not material), it produces no admissible evidence establishing a dispute over R2’s hospital physicians’ unwavering conclusions that R2 required the medication and that its omission contributed to her severe symptoms. Instead, Petitioner asks me to infer from witness statements and opinions that the drug error caused no ill effects. But the witnesses did not say this (which they could have, had they believed it), and to draw such inferences from their deliberately ambiguous remarks is not reasonable.
More important: even accepting, for purposes of summary judgment, that failing to administer thyroid medication to a woman who needed it caused her no ill effects, the
**Page 9**
issue is not material. The regulations do not require actual harm. *Life Care Ctr. of Elizabethton*, DAB No. 2367 at 6 (2011), and cases cited therein. Failing, for 44 days, to administer ordered medication – particularly a thyroid-replacement medication – to an individual who needs it must be considered a significant medication error that creates the “potential for causing more than minimal harm” and puts the facility out of substantial compliance, without regard to whether the resident was actually harmed.
Thus, I find not material Petitioner’s suggestion that R2’s medical crises were caused by her son’s insistence that some of her medications (ironically, those administered for congestive heart failure, diabetes, and hypertension, but not for hypothyroidism) be discontinued. P. Opp. at 9, *citing* P. Ex. 8. Petitioner and its witnesses point to notes of a very odd conversation between R2’s son and one of the nurses. I accept that R2’s son advocated discontinuing her drug regimen and may have temporarily succeeded in doing so. Although some of R2’s medications were discontinued on September 16, 2016 (P. Ex. 7 at 13), by December 9, they had been reinstated. CMS Ex. 4 at 35-40, 68-71; CMS Ex. 5 at 3, 5, 6. At the time of her hospital admission, R2 was taking Ceftriaxone (an antibiotic), Cholecalciferol (Vitamin D), Coumadin (blood thinner), Digoxin (to treat congestive heart failure), Humalog (insulin), Lasix (diuretic), vitamins, and zinc. CMS Ex. 5 at 9; *see* CMS Ex. 4 at 90-91 (showing that as of 12/08/2016, R2 was taking Cholecalciferol, Coumadin, Digoxin, furosemide (Lasix), Humalog, vitamins, zinc, and Glucogen, as needed, for diabetes).4
Referring to a letter from Peter Chang, M.D., R2’s physician, Petitioner also claims that Dr. Chang “unequivocally states that the missed thyroid medication did not play a role in [R2’s] medical problem that necessitated her hospitalization.” P. Br. at 7; P. Opp. at 11; *see*CMS Ex. 11; P. Ex. 5 at 17; *see also* P. Ex. 12 at 5 (Kofron Decl.); P. Ex. 13 at 6 (Duffley Decl.).5
 The physician letter offers a narrow opinion; Dr. Chang writes that R2’s return to the hospital “was not a result of her lack of levothyroxine administration.” P. Ex. 5 at 17; CMS Ex. 11. For purposes of summary judgment, I accept this. Ample evidence supports the finding that R2 suffered a multitude of serious impairments and that her urinary tract infection was the immediate reason she was hospitalized on January 26. However, it does not follow – *and Dr. Chang does not claim* – that failing to administer her thyroid medication caused R2 no actual harm. I find it telling that Dr. Chang limited his opinion to the cause of her January 26 hospitalization and said nothing
**Page 10**
about whether failing to administer the thyroid drug harmed her. He does not dispute her subsequent diagnosis of myxedema, nor the hospital physicians’ concerns about her untreated hypothyroidism, which are well-supported by the documentary evidence. CMS Ex. 5 at 18, 21-22, 37, 42-43, 48.
Ultimately, given the number and seriousness of R2’s medical conditions, it may not be possible to sort out which impairments caused which symptoms. Her hospital physicians opined that the thyroid deficiency contributed to her health problems, and Petitioner has come forward with no evidence or qualified medical opinion establishing a dispute.6
 But, even accepting, for purposes of summary judgment, that Petitioner’s many symptoms were caused by her other impairments, failing to administer the thyroid medication, by itself, constituted a significant medication error.
**Quality assurance committee**. Petitioner also argues that CMS is precluded from citing a deficiency because the facility’s quality assurance committee was addressing the problem. Inasmuch as the evidence establishing the facility’s substantial noncompliance here is wholly independent of any action by the quality assurance committee, I reject this contention.
A facility must maintain a quality assessment and assurance committee to identify quality issues and to develop and implement appropriate plans of action to address those issues. 42 C.F.R. § 483.75(g). The committee’s good faith attempts to identify and correct deficiencies will not be used as a basis for sanctions. 42 C.F.R. § 483.75(i).
Nothing in this record suggests that CMS learned of R2’s medication problems based on its review of the committee’s documents. To the contrary, the hospital initially discovered the error, and review of R2’s hospital and facility medical records confirmed it, independent of any actions by the quality assurance committee. While a significant medication error would likely (and should) trigger the committee’s scrutiny, that fact does not preclude CMS from finding a deficiency and imposing remedies. Indeed, to hold otherwise would mean that a facility could prevent surveyor scrutiny of its deficiencies simply by referring its deficiencies to the committee for study. *See Jewish Home of E. Pa.*, DAB No. 2254 at 9-13 (2009).
**Page 11**
***CMS’s determination as to the duration of the facility’s substantial noncompliance is consistent with statutory and regulatory requirements.***Petitioner suggests that the duration of the penalty is unfair because its quality assurance committee began correcting the deficiencies before the March 1 survey.
Once a facility has been found to be out of substantial compliance (as Petitioner was here), it remains so until it affirmatively demonstrates that it has achieved substantial compliance once again. *Ridgecrest Healthcare Ctr.*, DAB No. 2493 at 2-3 (2013); *Taos Living Ctr.*, DAB No. 2293 at 20 (2009); *Premier Living & Rehab Ctr.*, DAB No. 2146 at 23 (2008); *Lake City Extended Care*, DAB No. 1658 at 12-15 (1998). The burden is on the facility to prove that it is back in compliance, not on CMS to prove that deficiencies continued to exist. *Asbury Ctr. at Johnson City*, DAB No. 1815 at 19-20 (2002).
The facility must show that the incidents of noncompliance have ceased *and* that it has implemented appropriate measures to insure that similar incidents will not recur. *Libertywood Nursing Ctr.*, DAB No. 2433 at 15 (2011), *citing Life Care Ctr. of Elizabethton*, DAB No. 2367 at 16; *accord* 42 C.F.R. § 488.454(a) and (e); *Hermina Traeye Mem’l Nursing Home*, DAB No. 1810 at 12 (2002) (holding that, to be found in substantial compliance earlier than the date of the resurvey, the facility must supply documentation “acceptable to [CMS]” showing that it was in substantial compliance and *was capable of remaining in substantial compliance* on the earlier date); *Cross Creek Health Care Ctr.*, DAB No. 1665 (1998). A facility’s return to substantial compliance usually *must be established through a resurvey*. 42 C.F.R. § 488.454(a); *Ridgecrest*, DAB No. 2493 at 2-3.
Here, the facility has not met its burden of establishing that it returned to substantial compliance any earlier than the date of the survey. Its deficiencies were not the type (like a leaky roof or a broken dishwasher) that lend themselves to a quick fix. Not only did a nurse inaccurately delete a physician order, but, for 44 days, virtually every member of the nursing staff responsible for administering medications and monitoring her symptoms disregarded R2’s care plan. The plan’s so-called “target” and “revision” dates were simply ignored. And then, the pharmacy consultant did not notice the error. These problems were ongoing and systemic, not attributable to any one individual or incident.
The facility was thus required to review its practices, identify the areas of breakdown, and make changes to ensure that the problems did not recur. Staff had to be trained to follow new practices, and management had to ensure that the new practices were being followed and that they were effective. Until the facility could demonstrate that its training and other interventions were effective, i.e., that staff capably followed the training, that management put effective monitoring tools in place, and that those interventions resolved the problem, the facility has not met its significant burden of demonstrating that it has returned to substantial compliance. *Oceanside Nursing &*
**Page 12**
*Rehab. Ctr.*, DAB No. 2382 at 19 (2011); *Premier Living & Rehab Ctr.*, DAB CR1602 (2007), *aff’d*, DAB No. 2146 (2008).
The facility has thus not met its burden of establishing that it returned to substantial compliance any earlier than March 2, 2017.
***The penalties imposed – $2,875 followed by $305 per day – 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 (2001); *CarePlex of Silver Spring*, DAB No. 1638 at 8 (1999).
Here, CMS imposes per-day penalties of $2,875 and $305, which are in the lower to very-low ranges for per-day penalties ($105 to $6,289). 42 C.F.R. §§ 488.408(d)(1)(iii); 488.438(a)(1)(ii); 45 C.F.R. § 102.3 (table).7
 Considering the relevant factors, the penalty is reasonable.
The facility has a less-than-stellar history.
A complaint investigation, conducted on January 16-17, 2014, disclosed that the facility was not in substantial compliance with quality-of-care requirements, (then) 42 C.F.R. § 483.25(h), and that the deficiency posed a pattern of immediate**Page 13**
jeopardy to resident health and safety (Tag F323 cited at scope and severity level K). CMS Ex. 7 at 1.8
In a survey completed on June 11, 2014, the facility was not in substantial compliance with 42 C.F.R. § 483.60 (now 42 C.F.R. § 483.45), which governs **pharmacy services**. The deficiencies were widespread (Tag F425 cited at scope and severity level F). The facility was also out of substantial compliance with multiple life-safety code requirements. CMS Ex. 7 at 2.
	Another complaint investigation, completed May 27, 2015, cited widespread noncompliance with 42 C.F.R. § 483.35(i) (now 42 C.F.R. § 483.60), which governs food and nutrition services (Tag F371 cited at scope and severity level F). CMS Ex. 7 at 6.
	The May 27, 2015 complaint investigation again found widespread noncompliance with 42 C.F.R. § 483.60, which governs **pharmacy services** (Tag F425 cited at scope and severity level F). CMS Ex. 7 at 6.
	The May 27, 2015 investigation found widespread noncompliance with 42 C.F.R. § 483.65 (now 42 C.F.R. § 483.80), which governs infection control (Tag F441 cited at scope and severity level F). In addition, the facility had multiple life-safety code deficiencies. CMS Ex. 7 at 6.
	In a survey completed May 19, 2016, the facility was not in substantial compliance with 42 C.F.R. § 483.10(f) (now 42 C.F.R. § 483.10(j)), which governs resident rights: grievances; the deficiency was widespread (Tag F166 cited at scope and severity level F). CMS Ex. 7 at 10.
	The May 19, 2016 survey also found a pattern of substantial noncompliance under 42 C.F.R. § 483.13(a) (now 42 C.F.R. § 483.12) which governs resident behavior and facility practices (Tag F221 cited at scope and severity level E). CMS Ex. 7 at 10. And, again, the facility was not in substantial compliance with multiple life-safety code requirements. CMS Ex. 7 at 10.Thus, the facility has a history of substantial noncompliance, including repeated problems with its pharmacy services. That it was not able to maintain substantial compliance with the pharmacy requirements, by itself, justifies penalties significantly greater than the minimum. *See Cedar Lake Nursing Home*, DAB No. 2390 at 18-19 (2011); *Hallmark*
**Page 14**
*House Nursing Ctr.*, DAB No. 2226 at 19 (2009); *Burton Healthcare Ctr.*, DAB No. 2051 at 19 (2006); *Heartland Manor at Carriage Town*, DAB No. 1664 (1998).
Petitioner does not claim that its financial condition affects its ability to pay the penalty.
Applying the remaining factors, the magnitude of Petitioner’s problems is hard to overstate. As noted above, every person on the nursing staff charged with implementing the resident’s care plan neglected to do so. And the consultant pharmacist did not properly review the resident records in order to catch the significant medication error. For these serious, systemic problems, the facility is culpable. Because the undisputed evidence justifies the penalty amounts, CMS is entitled to summary judgment on this issue. *Senior Rehab. & Skilled Nursing Ctr.*, DAB No. 2300 at 20 (2010).
Conclusion
For these reasons, I grant CMS’s motion for summary judgment. The undisputed evidence establishes that the facility was not in substantial compliance with program requirements from December 14, 2016, through March 1, 2017. The penalties imposed – $2,875 per day for 44 days and $305 per day for 34 days of substantial compliance – are reasonable.


          /s/
        Carolyn Cozad Hughes

                      Administrative Law Judge
      1. The courts that have considered applying principles of summary judgment to Medicare administrative proceedings have carefully avoided any suggestion that deciding a case on summary judgment means that it is decided without a hearing. Throughout their decisions, they refer to deciding the case without an “oral hearing” or without an “evidentiary hearing.” The courts recognize that, 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”). back to note 1
                      2. My findings of fact and conclusions of law are set forth, in bold and italics, as captions in the discussion section of this decision. back to note 2
                      3. Staff’s failing to follow the resident care plan violates the quality-of-care regulation, which requires that the facility “ensure that residents receive treatment and care in accordance with . . . the comprehensive, person-centered care plan . . . .” 42 C.F.R. § 483.25. However, CMS did not cite a deficiency under section 483.25. back to note 3
                      4. In fact, at the time of her hospital admission, R2 was suffering from Coumadin toxicity and maybe Digoxin toxicity. CMS Ex. 5 at 5, 7. back to note 4
                      5. I agree with CMS that a written declaration would generally carry more weight than a letter, and CMS would be entitled to cross-examine Dr. Chang if this matter were decided based on an evidentiary hearing. 42 C.F.R. § 498.61. Nevertheless, Dr. Chang’s limited opinion seems consistent with the documentary evidence, and, in any event, the opinion is not material. back to note 5
                      6. Based on his review of the medical records, Registered Nurse Travis Duffley opines that, contrary to the unanimous opinion of her hospital physicians, R2 suffered no ill effects from thyroid depletion. He suggests that the diagnosis arrived at by multiple hospital physicians is invalid because the resident’s symptoms could be explained by her other impairments and because she did not experience all potential symptoms of myxedema. P. Ex. 13 at 6-7. For purposes of summary judgment, I am not bound to accept this conclusion, which is based on faulty logic, but, even if I were, the issue is not material. back to note 6
                      7. Penalties are inflation-adjusted and change (more or less) annually. The amount is determined as of the date the penalty is assessed, in this case on May 15, 2017. CMS Ex. 1 at 9; 82 Fed. Reg. 9174, 9182 (Feb. 3, 2017). back to note 7
                      8. The regulations governing long-term-care facilities were revised in October 2016, and the quality-of-care requirement is now found at 42 C.F.R. § 483.25(d). 81 Fed. Reg. 68,688, 68,828, 68,860 (Oct. 4, 2016). The substance of the regulation – which is also statutory – has not changed. back to note 8 Back to top
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