Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB No. 3036 (2021)

FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION

Logan Healthcare Leasing, LLC, which operates Logan Care and Rehabilitation (Petitioner), a skilled nursing facility (SNF) that participates in the Medicare program, has appealed a decision of an Administrative Law Judge (ALJ).  Logan Healthcare Leasing, LLC d/b/a Logan Care and Rehabilitation, DAB CR5677 (2020) (ALJ Decision).  The ALJ Decision upheld, on summary judgment, a determination by the Centers for Medicare & Medicaid Services (CMS) to impose on Petitioner a per-instance civil money penalty (CMP) of $20,905 based on a finding that Petitioner was not in substantial compliance with Medicare participation requirements in 42 C.F.R. § 483.25(d)(1) and (d)(2).  The determination arose from a January 14, 2018 incident in which a resident sustained a second-degree burn from smoking in his room, unsupervised by facility staff, and while receiving supplemental oxygen via nasal cannula. 

For the reasons explained below, we conclude that summary judgment was appropriate and that Petitioner was not in substantial compliance with the requirements in 42 C.F.R. § 483.25(d)(1) and (d)(2) based on undisputed material facts.  Petitioner did not challenge in this appeal the amount of the CMP, which we summarily affirm.  Accordingly, we affirm the ALJ Decision in its entirety. 

Legal Background

To participate in Medicare, a SNF must be in “substantial compliance” with Medicare participation requirements.  A SNF is not in substantial compliance when it has a “deficiency” – that is, a failure to meet a participation requirement – that creates at least the potential for more than minimal harm to one or more residents.  42 C.F.R. § 488.301 (defining “Substantial compliance” as “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”).  The term “noncompliance,” as used in the applicable regulations, is synonymous with lack of substantial compliance. 

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Id. (defining “Noncompliance”).1  Compliance with Medicare participation requirements is evaluated through onsite surveys performed by state survey agencies, which report their findings.  Id. §§ 488.10(a), 488.11, 488.18, 488.20, 488.305-310.

At issue here are the quality-of-care requirements in 42 C.F.R. § 483.25.  The prefatory language of section 483.25 provides:  “Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents.  Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices[.]”  Section 483.25(d) obligates a facility to minimize accident hazards and prevent accidents.  It states:

The facility must ensure that –

(1) The resident environment remains as free of accident hazards as is possible; and

(2) Each resident receives adequate supervision and assistance devices to prevent accidents.

42 C.F.R. § 483.25(d)(1), (d)(2).

CMS may impose one or more enforcement “remedies” on a SNF that is not in substantial compliance with a Medicare participation requirement.  42 C.F.R.§§ 488.400, 488.402(b)-(c), 488.406.  Remedies may include a CMP for each “instance of noncompliance.”  Id. §§ 488.408(d)(1)(iv), 488.408(e)(1)(iv), 488.430(a).  When CMS imposed the CMP here, the authorized range for a per-instance CMP was $2,097 to $20,965.  Id. §§ 488.408(e)(2)(ii), 488.438(a)(2); 45 C.F.R. § 102.3 (table); 82 Fed. Reg. 9174, 9188 (Feb. 3, 2017).  CMS sets the CMP within that range based on, among other factors, the “seriousness” of the noncompliance.  42 C.F.R. §§ 488.404(a)-(b), 488.438(f)(3).  Seriousness is a function of the scope of noncompliance (whether it is “isolated,” constitutes a “pattern,” or is “widespread”) and severity (whether it has created a “potential for” harm, resulted in “[a]ctual harm,” or placed residents in “immediate jeopardy”).  Id. § 488.404(b).  The most serious noncompliance is that which puts one or more residents in “immediate jeopardy.”  Id. § 488.301 (defining “Immediate

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jeopardy” to mean “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”).

A SNF may challenge a determination of noncompliance that has resulted in the imposition of an enforcement remedy by requesting an ALJ hearing and appealing any unfavorable decision by the ALJ to the Board.  42 C.F.R. §§ 488.408(g)(1), 498.3(b)(13), 498.5(b)-(c).  A SNF may also contest the reasonableness of the amount of any CMP imposed.  Lutheran Home at Trinity Oaks, DAB No. 2111, at 21 (2007).  A SNF may not, however, contest CMS’s finding about the “level of noncompliance” (e.g., a finding of immediate jeopardy) except in limited circumstances, such as when a successful challenge would affect the range of CMP amounts that CMS may impose.  42 C.F.R. § 498.3(b)(14).

Case Background

The following background facts are drawn from the ALJ Decision and the record of the ALJ proceedings.  These facts are undisputed unless otherwise indicated.    

Petitioner’s smoking policy (revised December 19, 2016 and in effect throughout the period at issue) required its staff to “establish and maintain safe resident smoking practices.”  CMS Ex. 28, at 1.  The policy included the following provisions:

• “Smoking restrictions shall be strictly enforced in all nonsmoking areas.”
• “Nursing staff shall perform a Smoking Assessment” and “determine restrictions on a resident’s smoking privileges.”
• “Any smoking-related privileges, restrictions, and concerns (for example, need for close monitoring) shall be noted on the care plan, and all personnel caring for the resident shall be alerted to these issues.”
• “Any resident with restricted smoking privileges requiring monitoring shall have the direct supervision of a staff member, family member, visitor or volunteer worker at all times while smoking.”
• “Smoking articles for residents WITHOUT independent smoking privileges:
  1. Residents without independent smoking privileges may not have or keep any types of smoking articles, including cigarettes, tobacco, etc., except when they are under direct supervision.
  2. Smoking shall not be permitted in bed ever.”

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• “This facility may check periodically to determine if residents have any smoking articles in violation of our smoking policies.  Staff shall confiscate any such articles, and shall notify the Charge Nurse/Unit Manager that they have done so.”

Id. at 1-2 (emphases in original). 

Resident 5 (R5), whose diagnoses included chronic obstructive pulmonary disease, pulmonary fibrosis, acute respiratory failure with hypoxia, hypoxemia, and shortness of breath, was admitted to the facility in September 2017.  CMS Ex. 10, at 10-11, 34.  Given his respiratory conditions, R5 used an oxygen tank and received continuous oxygen, 5 liters per minute, via nasal cannula.  Id.at 24, 25, 26; CMS Ex. 25, at 1.  R5 was alert, oriented, and able to make his needs and wishes known.  P. Ex. 1, at 6, 7; CMS Ex. 10, at 34.

On December 5, 2017, facility staff conducted a smoking assessment of R5, consistent with the facility policy to establish and maintain safe resident smoking practices.  CMS Ex. 10, at 41-42; CMS Ex. 28, at 1.  The assessment concluded:  “Resident is to be supervised when smoking.”  CMS Ex. 10, at 41.  Staff also assessed R5 to need staff to store lighters and cigarettes on his behalf.  Id.  The same day, staff initiated R5’s care plan, documenting that R5 was at risk for smoking-related injury.  CMS Ex. 25, at 21.  The care plan set out the following goal:  “[R5] will remain compliant with facility smoking procedure and smoking restrictions[.]”  Id.

In addition to a smoking policy, the facility also had in place a document entitled “Smoking Guidelines.”  The record includes a copy of the “Smoking Guidelines” bearing what appears to be R5’s signature dated December 5, 2017, the day of the smoking assessment.  CMS Ex. 10, at 40.  The Smoking Guidelines provided that residents may smoke only in the designated smoking area located outside “Building C/Rehab on the back side” during “open” smoking hours between 6 a.m. to 10:00 p.m., though it recognized “[t]here may be set times for one-on-one supervised smokers.”  Id.  The Smoking Guidelines also stated:  “All residents [who] use oxygen MUST leave oxygen inside the building in the ‘C’ building lobby.  There is to be no oxygen near the smoking area.”  Id. (emphases in original).

In the late morning of January 14, 2018, R5 told staff that he wanted to smoke.  CMS Ex. 10, at 14 (nursing note, “[R5] stated wanting to smoke or he wasn’t going to wear his oxygen”); CMS Ex. 10, at 49 (¶ 3) (affidavit of State-Tested Nursing Assistant (STNA)

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C. Hampshire,2 who attested, “[R5] said that he wasn’t going to wear his oxygen if he wasn’t allowed a cigarette”).  Staff counseled R5 on the hazards of smoking and the need to keep his oxygen in place.  P. Ex. 3, at 2; CMS Ex. 10, at 14, 44 (¶ 4), 46 (¶ 7).  R5 did not have any cigarettes available to him in the morning of January 14; but, a short time later that day, a visitor brought R5 smoking materials.  CMS Ex. 10, at 49 (¶ 4).  STNA Hampshire stated that she observed the visitor hand R5 a pack of cigarettes.  Id.  After the visitor left, facility staff observed R5, without his wheelchair or oxygen, walking outside to the designated smoking area on the patio.3  Id. at 14, 46 (¶ 11), 49 (¶ 5); CMS Ex. 23, at 2.    

STNA Hampshire stated that she followed R5 outside to supervise and saw that he already had a cigarette lit.  CMS Ex. 10, at 49 (¶¶ 5-6).  She sat with R5 while he smoked.  Then Licensed Practical Nurse (LPN) A. Wilson took over the supervision.  Id. at 46-47 (¶¶ 14, 17), 49 (¶¶ 6, 7); P. Ex. 3, at 2; see also P. Br. at 14.  Both staff members explained the smoking policy to R5 and told him that he would need to turn in his cigarettes after his smoke break, but R5 indicated he would not comply.  According to LPN Wilson and STNA Hampshire, R5 stated that staff would have to “pry the cigarettes from his cold, dead hands.”  CMS Ex. 10, at 47 (¶ 16), 49 (¶¶ 6, 7); CMS Ex. 23, at 2.  After R5 finished smoking, LPN Wilson helped him back inside, to his wheelchair.  CMS Ex. 10, at 47 (¶ 17), 14 (“[wheelchair] was left in facility/outside smoking area doors”).  Knowing that R5 had retained possession of his cigarettes, STNA Hampshire searched his room for smoking materials when he was not there.  CMS Ex. 10, at 49-50 (¶¶ 8, 14).   STNA Hampshire attested that she did not find any cigarettes or lighters in R5’s room.  Id. at 49 (¶ 8).  Petitioner asserts that, at approximately 7:00 p.m. on January 14, staff began to check on R5 at least every half hour.  P. Br. at 6-7, 13, 154; CMS Ex. 10, at 49 (¶ 10) (STNA Hampshire attesting that, “[a]t shift change, I reported to the on-coming

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STNA that [R5] had cigarettes” and that “[the on-coming STNA] was going to try to get the cigarettes later that night”).  LPN J. Meade, the evening nurse, attested that she observed R5 in bed at the beginning of her shift and that she did not see any cigarettes or lighters on him at that time.  CMS Ex. 10, at 56 (¶¶ 2, 6).

At approximately 8:00 p.m. on January 14, STNA S. Ruff called LPN Meade into R5’s room.  CMS Ex. 10, at 54 (¶ 4), 56 (¶ 7).  LPN Meade found STNA Ruff in the room, holding burnt and melted oxygen tubing.  Id.at 14, 56 (¶ 7).  R5, who was in bed, had “burn marks to [the] right side of [his] neck” and the neckline of his shirt was “scorched.”  Id.at 14, 56 (¶ 7).  R5 was wet from having poured water from a pitcher on himself to stop the burning.  Id.at 14, 56 (¶ 7).  At that time, R5 denied smoking, but staff found a pack of cigarettes, a lighter, and a styrofoam cup containing two cigarette butts on his bedside stand.  Id.at 56 (¶ 7).  LPN Meade completed a head-to-toe assessment and noted burns on R5’s neck.  Id.at 14.  R5 was transferred to a hospital for evaluation and treatment.  Id.  R5 was diagnosed with a second-degree burn to the right side of his neck.  CMS Ex. 26, at 4, 7, 8.  The hospital’s discharge orders were to clean and redress the burn daily for seven days; R5 was prohibited from smoking “until this problem [was] discussed with [his] attending doctor.”  Id. at 7.  Upon discharge from the hospital the next day, R5 returned to Petitioner’s facility.  Id. at 7, 9, 11; CMS Ex. 10, at 14, 17.

On January 30, 2018, the Ohio Department of Health (state agency) completed a complaint investigation of Petitioner’s facility.  CMS Ex. 1, at 1; CMS Ex. 3, at 1.  The state agency found that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1) and (d)(2) (Tag F689, Free of Accident Hazards/Supervision/Devices5) based on the January 14, 2018 incident involving R5 and that the noncompliance posed immediate jeopardy to resident health and safety.  CMS Exs. 9, 15.

By notice dated July 30, 2018, CMS informed Petitioner that it was imposing a $20,905 per-instance CMP for an immediate-jeopardy-level deficiency for failure to substantially comply with 42 C.F.R. § 483.25(d)(1) and (d)(2).  CMS Ex. 9, at 3.  Petitioner filed a

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request for hearing before an ALJ to challenge the citation and the CMP.6     

ALJ Proceedings and Decision

The ALJ’s prehearing order established a briefing schedule for the parties’ submissions. CMS filed a combined prehearing brief and motion for summary judgment, exhibit and witness lists, and 40 proposed exhibits.  Petitioner filed a combined opposition to CMS’s motion for summary judgment, cross-motion for partial summary judgment, and prehearing brief, exhibit and witness lists, and 10 proposed exhibits.  CMS filed a response to Petitioner’s cross-motion for summary judgment and objections to Petitioner’s proposed exhibits.

In the absence of any objection to CMS’s proposed exhibits, the ALJ admitted into the record CMS’s exhibits 1-40 (including a corrected CMS Ex. 1).  ALJ Decision at 3.  The ALJ admitted Petitioner’s exhibits 1-4 and 6-8 but excluded Petitioner’s exhibit 5 (February 16, 2019 affidavit of LPN Meade) as submitted late and without good cause, and Petitioner’s exhibits 9 and 10 as irrelevant because they concerned the Tag F925 deficiency for which Petitioner had no right to ALJ review.  Id. at 2-3; supra note 6.  CMS objected to the witnesses proposed by Petitioner (S. Secrest, LPN Wilson, STNA Hampshire, J. Evans, Maintenance Manager Tucker, N. Thompson, and LPN Meade) on the basis that Petitioner had failed to submit as proposed exhibits the written direct testimony of each witness with its prehearing exchange.  ALJ Decision at 3.  The ALJ overruled the objections, noting that Petitioner submitted the affidavits of those witnesses earlier, as exhibits to its request for hearing, and CMS later marked those affidavits as its own exhibits and submitted them as part of its own prehearing exchange.  Id. (referring to the affidavits submitted as part of CMS’s exhibit 10, pages 44-57).7 

On the deficiency cited as Tag F689, CMS asserted that the undisputed facts supported a conclusion that Petitioner failed to adequately supervise R5 in accordance with its smoking policy and assessment of the risk and hazards posed by R5’s smoking, and to

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prevent R5 from keeping and using smoking materials in his room.  Petitioner asserted that the smoking accident was unforeseeable and unavoidable; that the facility took all reasonable measures to reduce the accident risk; and that it did not violate 42 C.F.R. § 483.25(d)(1) and (d)(2).  The ALJ determined that, although Petitioner attempted to raise certain factual disputes, no factual dispute was material to the issues before her.  Moreover, the ALJ noted, many arguments concerned the legal significance of facts, not the existence of facts.  ALJ Decision at 6.  Accordingly, the ALJ determined that it would be appropriate to resolve the dispute by summary judgment.  Id. at 1, 6.

The ALJ determined that the undisputed facts, even viewed in the light most favorable to Petitioner, established that the facility failed to follow its own smoking policy by not directly supervising R5 while he had cigarettes in his possession.  Thus, the ALJ concluded that “Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1)-(d)(2) . . . because it failed to provide adequate supervision to prevent [R5’s] smoking accident.”  ALJ Decision at 6.  The ALJ granted summary judgment for CMS and denied Petitioner’s cross-motion for summary judgment.  Id. at 1, 17.

The ALJ considered and rejected Petitioner’s argument that the accident was unforeseeable and unavoidable because R5 had refused to relinquish his cigarettes and staff could not forcibly take the cigarettes from him.  ALJ Decision at 11 (citing P. Br. at 12, 19; CMS Ex. 10, at 47 (¶ 20)).  The ALJ noted:  “Petitioner apparently concedes that it did not follow that portion of its smoking policy prohibiting non-independent smokers from keeping smoking materials on their persons.  Petitioner instead asserts that it could not implement the policy without violating R5’s rights.”  Id.  Inferring that staff had tried but could not persuade R5 to surrender the cigarettes and accepting that staff could not have confiscated the cigarettes without using force (id. at 11-12, citing P. Br. at 12, 19; CMS Ex. 10, at 47 (¶ 16), 49 (¶ 6)), the ALJ reasoned –

Petitioner’s argument is, at bottom, a straw man.  It assumes that Petitioner’s only choices in response to R5’s refusal to turn over his cigarettes were either to take the cigarettes by force, or allow R5 to retain them without staff supervision.  Contrary to Petitioner’s argument, its own smoking policy offered Petitioner another option for dealing with R5’s refusal to give up his cigarettes:  direct supervision. . . .  Nor has Petitioner argued that direct supervision of R5 would have been impossible. . . .

Id. at 12 (citations to the record omitted).  As the ALJ pointed out, Petitioner’s smoking policy prohibited residents without independent smoking privileges, like R5, from having or keeping any type of smoking articles, including cigarettes, except under direct supervision.  Id. at 12, 14 (citing CMS Ex. 28, at 2 (¶ 13)).

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The ALJ also considered Petitioner’s argument that staff appropriately implemented the smoking policy.  According to Petitioner, the policy presumes staff has knowledge that a resident is smoking before the need for supervision is triggered, but staff could not have known of the need to supervise R5 because he smoked covertly in his room, despite repeated warnings about smoking hazards.  ALJ Decision at 12 (citing P. Br. at 4, 14, 20). 

The ALJ rejected the argument that staff could not have known R5 needed supervision after his supervised smoke break because the staff’s own actions – searching R5’s room for smoking materials (including specifically a lighter8) and placing R5 on 30-minute checks starting at approximately 7 p.m. – indicated that staff contemplated the possibility that R5 would or could smoke in his room.  ALJ Decision at 12 (citing CMS Ex. 10, at 49 (¶ 8), 50 (¶ 14) and P. Br. at 13, 15).  The ALJ also observed that R5’s refusal to comply with the policy by refusing to turn over the cigarettes to staff “made it more likely – not less so – that he might ignore the facility’s rules and warnings against smoking in his room.”  Id. at 12-13.  Thus, the ALJ stated, although “Petitioner took some steps to address the risk that R5 would smoke in his room in violation of facility policy,” those “steps . . . were not ‘adequate’ to ‘ensure’ that R5’s environment was as free of accident hazards as possible and did not constitute adequate supervision under the circumstances.”  Id. at 13.

Petitioner suggested that R5 had assumed the risk of smoking in his room despite the interventions and warnings.  P. Br. at 14.  Rejecting the “assumption of risk” argument as based on a common law tort concept, the ALJ stated that R5’s smoking in his room in violation of facility policy did not absolve Petitioner of its duty to protect R5 from accident hazards inasmuch as federal law and regulations required Petitioner to ensure that residents remain as free from accident hazards as practicable.  ALJ Decision at 13 n.11.  The ALJ also observed that, even accepting that R5 had assumed the risk of smoking in his room in the presence of oxygen, Petitioner still would have to meet its duty to protect other residents from the danger of a fire that might spread beyond R5’s room.  Id. (citing Century Care of Crystal Coast, DAB No. 2076, at 18 (2007), aff’d, Century Care of the Crystal Coast v. Leavitt,281 F. App’x 180 (4th Cir. 2008) (“The facility should also have considered the risk to other residents in the event of an oxygen explosion or fire in determining how much reliance to place on [the resident’s] judgment.”)).

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The ALJ also noted inadequacies concerning the room sweep and the 30-minute checks.  The ALJ observed that, conducting a sweep of R5’s room9 was “inadequate” to mitigate the risk that R5, “with cigarettes still in his possession, might later obtain a lighter from another resident or visitor.”  ALJ Decision at 13.  And, the ALJ noted, the room sweep failed to address the risk that R5 already had a lighter on his person, which the facility later found to be the case.  Id. (citing P. Br. at 14 (“Clearly, [R5] had all smoking materials on his person – a fact that only became known to staff after the accident.”) (emphasis by Petitioner)).  As for the 30-minute checks, the ALJ accepted for purposes of summary judgment that staff had performed them (id. at 10 n.10) but noted that Petitioner did not explain what each “check” entailed.  Id. at 13.  In any case, the ALJ observed, the checks began with a shift change at 7 p.m., leaving no interventions in place to address the risk of an accident during a period of at least three hours between the end of R5’s smoke break and the evening shift change – a period during which R5 was left alone, with cigarettes.10  Id. (citing P. Br. at 6-7, 13, 15 and P. Ex. 3, at 2 (documenting R5’s smoke break at 3:55 p.m. (15:55))).  Rejecting the argument that staff could not have reasonably known R5 would “sneak a cigarette between 30-minute checks” (P. Br. at 14), the ALJ reasoned that, had staff directly supervised R5 while he was in possession of smoking materials (as required by its smoking policy), it would not have had to consider the risks posed by the 30-minute checks.  ALJ Decision at 13 n.12. 

Further, the ALJ noted that Petitioner failed to explain through its brief or to show by evidence why it deviated from its smoking policy.  ALJ Decision at 14.  The policy, the ALJ noted, prohibited residents without independent smoking privileges (such as R5) from having or keeping any smoking materials “except when under direct supervision.”  Id. (citing CMS Ex. 28, at 2 (¶ 13) (emphasis added by ALJ)).  The ALJ further noted this duty to supervise was in no way limited to situations where staff knew a resident was engaged in the act of smoking.  Id.  Accordingly, the ALJ determined, staff did not comply with the policy provision to directly supervise R5 while he possessed smoking materials (i.e., the cigarettes he had received from a visitor).  Id.  The ALJ thus concluded that the facility’s failure to directly supervise R5 while he had cigarettes in his possession, in violation of its own policy, amounted to a failure to comply substantially with 42 C.F.R. § 483.25(d)(1) and (d)(2).  Id.

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Applying the factors in 42 C.F.R. §§ 488.438(f) and 488.404 (the latter referenced in section 488.438(f)(3)), the ALJ also determined that the $20,905 CMP – which the ALJ stated was “close to the then-maximum amount for a per-instance CMP” – was reasonable.  ALJ Decision at 15 & 15 n.13 (citing 82 Fed. Reg. 9174, 9188 (Feb. 3, 2017)).  In so determining, the ALJ indicated her agreement with CMS as to the seriousness of, and Petitioner’s culpability for, the deficiency.  Id. at 15-16 (referring to CMS Br. at 24).  In the ALJ’s assessment, the deficiency was “extremely serious” because R5 sustained actual harm, a second degree burn on his neck, which required emergency room care.  Id. at 16 (citing CMS Ex. 10, at 14 and CMS Ex. 26, at 7).  Smoking near flowing oxygen (which R5, who was on continuous oxygen, did) was, the ALJ said, “extremely dangerous” given the potential to harm R5, other residents and staff.  Id.  On culpability, the ALJ observed that the facility’s failure to comply with its own smoking policy, which “led directly to R5’s smoking-related injuries and put other residents and staff at risk,” “demonstrates a disregard for resident safety.”  Id.  Rejecting the assertion that R5 “recognized his culpability for the event” (P. Br. at 17), the ALJ noted that, “whatever the extent” of R5’s culpability, Petitioner was not relieved of its share of culpability, which the ALJ characterized as “significant” and “justif[ying] an increased” CMP amount.  ALJ Decision at 16. 

On the argument that the CMP is “excessive” in light of the facility’s “good survey history” and that Petitioner is “not a facility that is accustomed to receiving citations for substandard care” (P. Br. at 17), the ALJ noted enforcement history data that revealed the imposition of a CMP for two citations after a March 2017 survey.  ALJ Decision at 16 (citing CMS Ex. 14, at 2).  The ALJ observed that although those earlier citations did not involve “substandard quality of care,” “if anything, the recent CMP imposed within a year before the survey at issue would support an increased CMP amount, as well.”  Id. 

Petitioner did not assert that it could not pay the CMP.  ALJ Decision at 16 (citing Gilman Care Ctr., DAB No. 2357, at 7 (2010) (facility must prove its financial condition by the preponderance of the evidence)).

Considering, “[o]verall, the seriousness of the deficiency and the facility’s culpability,” the ALJ determined that the $20,905 per-instance CMP was “fully justif[ied]” and reasonable even without regard to the facility’s compliance history.  ALJ Decision at 17.

Standard of Review

We review whether summary judgment is appropriate de novo.  Southpark Meadows Nursing & Rehab. Ctr., DAB No. 2703, at 5 (2016).  “Summary judgment is appropriate when the record shows there is no genuine issue as to any material fact, and the moving party is entitled to judgment as a matter of law.”  Id.  A dispute of fact is “material” if its resolution might affect the case’s outcome under the governing law.  Id. (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)). 

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In evaluating a party’s motion for summary judgment, we view the record in the light most favorable to the non-moving party (or, here, Petitioner, the party that did not prevail before the ALJ on summary judgment) and giving that party the benefit of all reasonable inferences.  See id.; Pearsall Nursing & Rehab. Ctr., DAB No. 2692, at 5 (2016); Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); U.S. v. Diebold, Inc., 369 U.S. 654, 655 (1962).  Drawing factual inferences in the light most favorable to the non-moving party does not, however, require that a reviewer draw unreasonable inferences or accept the non-moving party’s legal conclusions.  Brightview Care Ctr., DAB No. 2132, at 10 (2007); Cedar Lake Nursing Home, DAB No. 2344, at 7 (2010).  Inferences based on speculation are not reasonable.  Dumas Nursing & Rehab., L.P., DAB No. 2347, at 18 (2010).  Nor may the adjudicator make credibility determinations or weigh the evidence when deciding a summary judgment motion.  See Anderson, 477 U.S. at 249.

Our standard of review on a disputed conclusion of law is whether the ALJ’s decision is erroneous.  Guidelines -- Appellate Review of Decisions of Administrative Law Judges Affecting a Provider’s Participation in the Medicare and Medicaid Programs, https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/guidelines/participation/index.html.

Analysis

Petitioner asserts that the ALJ’s determination to grant summary judgment for CMS is “contrary to the regulations and the evidence.”  Request for Review (RR) at 1.  According to Petitioner, the ALJ wrongly “imposed [on Petitioner] a standard of practice . . . that is unsupported by the regulations.”  Id.  Petitioner asks us to “reverse” the ALJ’s decision and remand this case to the ALJ for a hearing.  Id. at 1, 4.

We address Petitioner’s arguments in detail below.  For the reasons set out below, we conclude that the undisputed material facts establish that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1) and (d)(2), and that the ALJ did not err in granting summary judgment for CMS.  Accordingly, we affirm the ALJ Decision.

I.   Summary judgment is appropriate because the undisputed material facts establish that Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(d)(1) and (d)(2).

Section 483.25 obligates a facility to make “quality of care,” as described in the regulation, a fundamental principle applicable “to all treatment and care provided to facility residents.”  “Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with . . . the comprehensive person-centered care plan” and “the resident’s choices.”  Id.To that end,

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section 483.25(d)(1) (formerly section 483.25(h)(1)),11 obligates a facility to provide a resident environment that is “as free of accident hazards as is possible.”  This requirement “places a continuum of affirmative duties” on the facility.  Maine Veterans’ Home - Scarborough, DAB No. 1975, at 6 (2005).  A facility must identify and remove hazards, where possible, or where the hazard is unavoidable because of other resident needs, manage the hazards by reducing accident risks to the extent possible.  Id. at 10; Meridian Nursing Ctr., DAB No. 2265, at 3 (2009), aff’d sub nom. Fal-Meridian, Inc. v. United States Dep’t of Health & Human Servs., 604 F.3d 445 (7th Cir. 2010).  In accordance with section 483.25(d)(2), a facility must take “all reasonable steps to ensure that a resident receives supervision . . . that meet[s] his or her assessed needs and mitigate[s] foreseeable risks of harm from accidents.”  Briarwood Nursing Ctr., DAB No. 2115, at 5 (2007) (citing Woodstock Care Ctr. v. Thompson, 363 F.3d 583, 590 (6th Cir. 2003), aff’g Woodstock Care Ctr., DAB No. 1726 (2000)). 

“[T]he federal requirements are based on an ‘outcome-oriented’ approach, in which the regulations establish outcomes facilities must achieve, but provide each facility with flexibility to select methods to achieve them that are appropriate to its own circumstances and needs.”  Azalea Court, DAB No. 2352, at 9 (2010) (citing Virginia Highlands Health Rehab. Ctr., DAB No. 2339, at 5 (2010), citing Lake Mary Healthcare, DAB No. 2081, at 17 (2007)), aff’d, Azalea Court v. United States Dep’t of Health & Human Servs., 482 F. App’x 460 (11th Cir. 2012).  Accordingly, the “failure to take measures that are reasonably necessary, under the circumstances, to achieve an outcome required by the regulation . . . to ensure that the resident environment remains as free of accident hazards as is possible and that residents receive supervision adequate to prevent accidents” may establish “noncompliance, even though the regulation does not specify the particular measures that the facility must or may take to achieve these outcomes.”  Azalea Court at 9 (emphasis in original).

To provide a resident “adequate supervision” consistent with section 483.25(d)(2), a facility has flexibility to choose how to supervise a resident “as appropriate to [its] circumstances and to employ reasonably necessary measures to comply with the regulation”; but, the measures chosen must be able to “reduce known or foreseeable accident risks to the highest practicable degree. . . .”  Heritage Plaza Nursing Ctr., DAB No. 2829, at 6, 20 (2017) (quoting Century Care of Crystal Coast, DAB No. 2076, at 6-7 and Lifehouse of Riverside Healthcare Ctr., DAB No. 2774, at 15 (2017)); see also Windsor Health Care Ctr., DAB No. 1902, at 5 (2003) (supervision or other accident-

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prevention measures taken must be “adequate” “under all the circumstances”), aff’d Windsor Health Ctr. v. Leavitt, 127 F. App’x 843 (6th Cir. 2005); Del Rosa Villa, DAB No. 2458, at 19 (2012) (whether a facility complied with section 483.25(h)(2) depends on whether it took all reasonable and practicable measures to identify, evaluate, and reduce or eliminate the foreseeable risk of an accident), aff’d, Del Rosa Villa v. Sebelius, 546 F. App’x 666 (9th Cir. 2013); Libertywood Nursing Ctr., DAB No. 2433, at 7 (2011) (“ensuring” adequate supervision involves identifying and minimizing safety risks), aff’d, Libertywood Nursing Ctr. v. Sebelius, 512 F. App’x 285 (4th Cir. 2013); Clermont Nursing & Convalescent Ctr., DAB No. 1923, at 21 (2004) (section 483.25(h)(2) requires a facility to eliminate or reduce a known or foreseeable “risk of accident to the greatest degree practicable”), aff’d, Clermont Nursing & Convalescent Ctr. v. Leavitt, 142 F. App’x 900 (6th Cir. 2005).

A facility’s obligations under section 483.25 also includes furnishing the care and services set forth in its own resident care policies.  Life Care Ctr. of Bardstown, DAB No. 2479, at 22 (2012) (citing cases), aff’d, 535 F. App’x 468 (6th Cir 2013); Life Care Ctr. of Tullahoma, DAB No. 2304, at 34 (2010) (the care and services required by section 483.25 include care and services called for by a facility’s resident care policy), aff’d, Life Care Ctr. Tullahoma v. Sec’y of United States Dept. of Health & Human Servs., 453 F. App’x 610 (6th Cir. 2011); Good Shepherd Home for the Aged, Inc., DAB No. 2858, at 12 (2018) (section 483.25 obligates a SNF to follow its own resident care policies).  Indeed, “[o]nce a facility adopts a policy that incorporates the measures that are appropriate to assure that residents receive adequate supervision and assistance devices to prevent accidents . . . the facility is held to follow through on them.”  Heritage Plaza, DAB No. 2829, at 20.

Moreover, “[a] facility policy such as [a] smoking policy,” the Board has said, “may play various roles in evaluating compliance with federal requirements.”  Oxford Manor, DAB No. 2167, at 5 (2008) (citing Spring Meadows Health Care Ctr., DAB No. 1966, at 16-20 (2005) and Century Care of Crystal Coast, DAB No. 2076).  As here, a facility’s smoking policy may show that the facility recognized the dangers of permitting residents to have or keep cigarettes or lighters in their possession, smoking in bed, and smoking in other than designated areas.  See Oxford Manor at 5; CMS Ex. 28, at 1-2.  The facility’s policy may also show the “standard of care the facility expected its staff to provide.”  Oxford Manor at 5.

A.   Petitioner failed to take all reasonable steps, including adequate supervision of R5’s smoking activity consistent with the facility’s smoking policy, to prevent the accident that occurred in the evening of January 14, 2018. 

Petitioner challenges the ALJ’s determination that it “failed to take all reasonable steps to prevent the smoking accident that occurred” because staff “did not directly supervise R5 while he had cigarettes in his possession.”  ALJ Decision at 11.  Petitioner maintains that

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it acted reasonably and consistent with the facility’s smoking policy.  Petitioner first points to “multiple interventions” its staff implemented “to promote R5’s safety upon learning that he had been given cigarettes” by a visitor.  RR at 1-2 (Petitioner’s emphasis removed).  The record includes, Petitioner says, undisputed evidence of staff interventions in the form of direct supervision of R5 while he smoked the cigarettes he had obtained from a visitor, outside at the designated smoking area; staff asking R5 whether he had smoking materials (R5 admitted to having cigarettes but denied having a lighter); staff counseling R5 on smoking hazards and the facility’s smoking policy; performing a “sweep” of R5’s room to locate any smoking materials; and placing R5 on 30-minute checks.  Id. at 2. 

Staff performed a smoking assessment of R5 consistent with facility policy to establish and maintain safe resident smoking practices and to determine any necessary restrictions on R5’s smoking privileges.  CMS Ex. 10, at 41-42; CMS Ex. 28, at 1.  Based on that assessment, staff determined that R5 was at risk for smoking-related injury and could not smoke independently.  CMS Ex. 10, at 41-42.  Staff took interventions, notably, providing R5 direct supervision while he smoked in the afternoon of January 14, outside at the designated smoking area, consistent with staff’s determination on R5’s needs, the smoking policy, and Smoking Guidelines.  CMS Ex. 10, at 40, 46-47 (¶¶ 14, 17), 49 (¶¶ 6, 7); CMS Ex. 28, at 1-2; P. Ex. 3, at 2.  These facts are undisputed and support Petitioner’s position that its staff took some mitigation steps.

However, as the Board has stated in prior decisions discussed above, in evaluating whether a facility complied with section 483.25(d), the issue is not whether the facility took some steps to mitigate an assessed risk.  Rather, the issue is whether the facility took all reasonable steps to mitigate an assessed risk.  See Briarwood Nursing Ctr., DAB No. 2115, at 5.  Accordingly, the question here is whether Petitioner’s staff took all reasonable steps to ensure R5 received the supervision that met his assessed needs to mitigate against the foreseeable risk of harm posed by his smoking activity and possession of cigarettes.12  They did not do so on the evening of January 14.

Petitioner did not adequately supervise R5 the evening of January 14, while he had cigarettes in his possession.  ALJ Decision at 11, 12, 14.  The failure to do so unquestionably violated the facility’s smoking policy (CMS Ex. 28, at 1-2), which required, among other things, that any resident with restricted smoking privileges (such as R5) must be directly supervised while smoking and be under direct supervision when

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they have any type of smoking articles, including cigarettes.  As the ALJ stated, correctly, once a facility adopts a policy that incorporates measures it has determined are appropriate to assure that residents receive adequate supervision to prevent accidents, it will be held to follow through on that policy.  ALJ Decision at 11.  If it did not, then that failure could support a finding that the facility did not meet the regulatory standard.  See id.; see also Oxford Manor, DAB No. 2167, at 5-6 (the accident-prevention measures a facility decides to take may be set out in a facility’s resident care policy, such as a smoking policy); Hanover Hill Health Care Ctr., DAB No. 2507, at 6 (2013) (“[A] facility’s own policy may be sufficient evidence . . . of what the facility has determined is needed to meet the quality of care requirements in section 483.25.”); Bivins Mem’l Nursing Home, DAB No. 2772, at 9 (2017) (cited in ALJ Decision at 11) (a facility’s “failure to comply with its own policies can support a finding that the facility did not achieve compliance with the regulatory standard”).  Here, Petitioner’s undisputed failure to comply with its Smoking Policy (and the absence of contemporaneous evidence documenting a stated exception based on professional judgment for departing from its policy) demonstrates that Petitioner did not take all reasonable steps to mitigate the risk of a smoking accident.  See Oxford Manor at 5-6.

Apart from Petitioner’s failure to comply with its own smoking policy, we must also ask whether the actions staff took to mitigate the risk of harm were reasonable and sufficient under the circumstances, especially when staff well knew, following the afternoon smoke break on January 14, that R5 had retained cigarettes and remained resistant to heeding the warnings about the hazards of smoking and complying with the facility’s smoking restrictions.  As discussed earlier, the facility’s interventions included conducting a room sweep and then later putting R5 on 30-minute checks.  But, as the ALJ noted, conducting a room sweep (which turned up nothing) left open the possibility that R5 might later obtain a lighter from another resident or visitor; it also left open the possibility that R5 already had a lighter on his person.  See ALJ Decision at 13.  Moreover, it is undisputed Petitioner’s staff knew R5 had the cigarettes on his person and would not leave his smoking materials anywhere where staff would be able to find and remove them.  CMS Ex. 10, at 47 (¶ 19).  Thus, the room sweep, according to Petitioner’s own staff, was not adequate.  See id. 

Still further, as the ALJ found, the 30-minute checks implemented by Petitioner on the evening of January 14 left gaps in supervision that exposed R5 and other residents to unnecessary risks between checks.  ALJ Decision at 13.  And, it is undisputed that staff did not begin performing 30-minute checks until the shift change around 7 p.m., which left at least a three-hour gap in time after R5’s afternoon smoke break during which he had possession of cigarettes with no supervision.  See id.

It is undisputed that a visitor gave R5 a pack of cigarettes in the afternoon on January 14 and that R5 smoked at least one cigarette under staff supervision at that time.  It is also undisputed that staff knew R5 retained the cigarettes in his possession.  RR at 3

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(“Petitioner was on notice that the visitor gave R5 cigarettes”); CMS Ex. 10, at 47 (¶ 19) (“I knew he had the cigarettes on his person. . . . I knew he wasn’t going to put them anywhere the staff would be able to pick them up and remove them.”).  Nevertheless, Petitioner contends that as long as the staff were operating on the reasonable assumption that R5 did not have a lighter, they had no reason to think that R5 required direct supervision.  RR at 3 (“Petitioner had no notice that the visitor gave him a lighter”; “Direct supervision wasn’t necessary because a cigarette without a light isn’t immediately dangerous.”).  To bolster its argument that direct supervision of R5 was unnecessary, Petitioner also states that R5 had no cigarettes available to him until a visitor gave him cigarettes on January 14, R5 had not smoked at the facility before January 14, and that the Minimum Data Set with an assessment reference date of October 20, 2017, provided that R5 was not then a current tobacco user.  Id. at 3 (citing CMS Ex. 10, at 44, 46, 49; P. Ex. 1, at 25).   

We reject the assertion that direct supervision of R5 was not necessary.  Even accepting that staff had no reason to think R5 had a lighter on January 14 and that belief was reasonable, staff did not act reasonably under the circumstances.  On December 5, 2017, staff performed a smoking assessment, which reported that R5 smokes 2-5 times per day, he likes to smoke at all times of day, he can light his own cigarette, and he has no desire to quit smoking.  CMS Ex. 10, at 41.  Based on the smoking assessment, staff further determined that R5 needed to be supervised when smoking, and the facility needed to store any lighter and cigarettes for him.  Id.  Further, since R5 smoked in the afternoon of January 14 in the presence of staff (but without scheduling a supervised smoke break and, according to staff, without having his own lighter) and having refused to relinquish the cigarettes he had received earlier that day, facility staff were unquestionably on notice that R5 might attempt to smoke again whether or not staff believed he had his own lighter.  Yet staff did not take appropriate action to protect R5 and others.  Petitioner presented no evidence that its staff could not have provided direct supervision of R5 in the evening of January 14. 

The record thus supports that staff knew, or reasonably should have known, of the heightened risk of R5 smoking the cigarettes in his possession, while unsupervised, which posed a risk of harm to him and others.  We find the “interventions” Petitioner took by repeatedly warning and counseling R5, supervising R5’s afternoon smoke break, performing a room sweep, and performing 30-minute checks (RR at 1-2) were not sufficient under the circumstances.  As the ALJ rightly stated, Petitioner had another option, which was direct supervision of R5 consistent with Petitioner’s smoking policy, which would have avoided the risk that R5 could smoke unsupervised between the 30-

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minute checks.13  See ALJ Decision at 12, 13 n.12.  Petitioner did not assert or show it could not have provided R5 direct supervision in the evening of January 14.  Id. at 12 (ALJ, citing CMS Ex. 10, at 44 (¶ 9), and stating that “[n]or has Petitioner argued that direct supervision of R5 would have been impossible”).  To the contrary, LPN Secrest submitted testimony asserting that had she known R5 had a lighter, she would have put him on 1:1 supervision until it was safely secured by staff.  CMS Ex. 10, at 44 (¶ 9).  The evidence, therefore, is uncontroverted that the same measure could have been taken (consistent with Petitioner’s smoking policy) until staff was able to safely secure R5’s cigarettes.

Petitioner also argues that R5 had disregarded staff’s warnings and admonitions and made “intentional misrepresentations” to Petitioner.  RR at 2.  Petitioner, moreover, states that R5 sustained burn injuries because he “opted to assume the risk of his foolhardy behavior,”14 not as a result of staff’s failure to substantially comply with any regulation.  Id.  Petitioner, however, had a duty to protect R5 (and others) from accident hazards.  ALJ Decision at 13 n.11.  The risk of harm posed by R5’s smoking was unquestionably foreseeable.  Petitioner was not absolved of its duty to protect residents because R5 chose to smoke in his room in violation of facility policy, despite repeated warnings about accident hazards.  Petitioner had an obligation to take all reasonable accident-prevention steps, including supervision of R5’s smoking and possession of cigarettes, to meet that duty, but failed to do so.

The undisputed facts establish that Petitioner did not ensure that the facility remained as free of accident hazards as is possible, and that R5 received adequate supervision to prevent a smoking-related accident.  Thus, we conclude that a rational trier of fact, even viewing the record in the light most favorable to Petitioner and drawing all reasonable inferences in its favor, could not find that Petitioner was in substantial compliance with section 483.25(d)(1) or (d)(2).

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B.   Petitioner’s arguments concerning care-planning have no merit; they raise no question of material fact that could defeat summary judgment for CMS. 

The ALJ considered evidence that R5 underwent a smoking assessment on December 5, 2017, which documented, among other things, that R5’s care plan would be used to assure R5 remained safe while smoking and that the facility needed to store any cigarettes or lighters on behalf of R5.  CMS Ex. 10, at 41.  The ALJ noted that staff updated R5’s care plan the same day, documenting R5’s “risk for injury [related to] Smokes tobacco-cigarette products.”  ALJ Decision at 7 (quoting CMS Ex. 25, at 21).  The ALJ also noted, however, the care plan indicated the intervention to have nursing staff store R5’s smoking materials was initiated on January 15, the day after the accident.  Id.at 7-8 and 8 n.7 (citing CMS Ex. 25, at 21 and CMS Ex. 10, at 41).  The ALJ wrote, “It therefore appears that the intervention to store R5’s smoking materials should have been care planned as of December 5, 2017.”  Id. at 8 n.7. 

Petitioner apparently reads the ALJ’s footnote about care-planning to mean the ALJ determined that “a resident’s care plan must be updated upon the initiation of every new intervention.”  RR at 2.  Petitioner maintains that 42 C.F.R. § 483.21 (captioned “Comprehensive person-centered care planning”) does not require a facility to immediately enter or update an intervention in a resident’s care plan.  In accordance with section 483.21(b)(2), Petitioner says, a facility must develop a comprehensive care plan within seven days after completing a comprehensive assessment, but section 483.21 does not otherwise specify when a care plan must be updated outside the context of a comprehensive assessment.  Id.  Accordingly, says Petitioner, “assuming the event of [R5] obtaining cigarettes” constituted a “significant change” as contemplated by CMS guidance, Petitioner had seven days to update R5’s care plan to include interventions performed immediately after staff became aware that R5 had cigarettes.  Id. (citing State Operations Manual, Appendix PP guidance for Tag F657, at 22615).  Petitioner asserts that the ALJ therefore “improperly considered” whether Petitioner had failed to update the care plan when she decided to grant CMS’s motion for summary judgment.  Id.  Petitioner also expresses its view that it was “disingenuous” for the ALJ to have “grant[ed] summary judgment against Petitioner for placing people over paperwork” when Petitioner had implemented multiple “person-centered” interventions to promote R5’s safety and well-being.  Id.

Petitioner misunderstands the ALJ’s discussion about care-planning.  The ALJ did not grant summary judgment against Petitioner because R5’s care plan was not immediately updated.  Petitioner’s arguments go beyond the confines of the ALJ’s discussion and are not on point.  They raise no material factual issue.      

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It is undisputed that one particular intervention – to have staff store R5’s smoking materials for R5 – was not documented in R5’s care plan as of January 14, the day of the accident.  This intervention was initiated the next day.  CMS Ex. 25, at 21 (care plan, stating, in relevant part, “Nursing to store smoking materials for resident.  Date Initiated:  01/15/2018”).  While the ALJ opined that Petitioner did not timely update R5’s care plan to include this intervention, this was not the basis for her conclusion that Petitioner violated 42 C.F.R. § 483.25(d)(1) and (d)(2) or for CMS’s noncompliance determination.  The ALJ concluded that Petitioner did not comply with 42 C.F.R. § 483.25(d)(1) and (d)(2) because it did not take all reasonable steps to prevent the foreseeable accident in light of R5’s assessed needs, facility policy, and the undisputed facts surrounding the episode.  

C.   Petitioner’s remaining arguments are meritless; they raise no material factual issue that could defeat summary judgment for CMS. 

Petitioner asserts that, in accordance with the terms of the smoking assessment, R5 was to be supervised only “when smoking.”  RR at 2 (citing CMS Ex. 10, at 41).  Petitioner says, “[I]mplicit in the smoking assessment and the smoking policy is that Petitioner must be aware that a resident is engaged in the activity of smoking to trigger the requirements for supervision.”  Id. at 2-3.  Petitioner says that, in this instance, there is “no evidence or suggestion” that staff were aware R5 was smoking in his room in the evening of January 14, and, accordingly, no need for supervision was even triggered.  Id. at 3.  According to Petitioner, based on the smoking assessment, staff determined that R5 “did not need supervision and/or one-on-one assistance.”  Id. at 3 (Petitioner’s emphasis). 

The smoking assessment does include the following handwritten notation:  “Resident [5] is to be supervised when smoking.”  CMS Ex. 10, at 41.  Relying on this notation, Petitioner apparently would have us infer that it was only necessary to supervise R5 when he was actually engaged in the act of smoking regardless of any other facts or circumstances.  Such an inference is not reasonable and is contradicted by the facility’s own policy and R5’s smoking assessment.  The meaning of the notation in the smoking assessment (R5 “is to be supervised when smoking”) must be considered in context, together with other parts of the assessment and the smoking policy.  First, the smoking assessment itself determined that R5 would not be permitted to retain cigarettes and lighters himself.  CMS Ex. 10, at 41 (determining that the facility needed to store any cigarettes and lighter for R5).  Second, Petitioner’s smoking policy sets out numerous preventive safety measures to be taken in advance or on an ongoing basis even when a resident is not in the act of smoking.  Those measures include performing a smoking assessment; alerting staff about smoking privileges, restrictions, and concerns; and periodically checking for resident possession of smoking materials in violation of facility policy and confiscating the materials.  CMS Ex. 28, at 1-2.  Significantly, it also requires direct supervision when a resident like R5 is in possession of cigarettes—regardless of whether the resident also has a lighter.  Id. at 2 (¶ 13).  Reading the assessment notation

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to mean that the obligation to supervise is “triggered” only when staff actually know a resident is smoking is not compatible with the policy terms; nor would such a reading serve the purposes underlying the assessment, the smoking policy, and the regulation.

Petitioner points to the smoking policy provision which states that residents without independent smoking privileges may not retain smoking articles, except under direct supervision, and argues that “the focus of the policy is on those articles designed to light a cigarette, not on the cigarette itself.”  RR at 3 (also stating that “a cigarette without a light isn’t immediately dangerous”).  But this argument directly contradicts the plain language of the smoking policy, which broadly refers to “any types of smoking articles, including cigarettes, tobacco, etc.” and is not at all limited to materials that could be used to light cigarettes.  See CMS Ex. 28, at 2 (¶ 13).  The language of the policy contemplates, broadly, items that could be used for smoking and does not contemplate only staff monitoring of tobacco lighting products, but not tobacco products themselves.  The notion that Petitioner’s “Smoking Policy” is focused on staff monitoring of items used to light tobacco but not tobacco is unreasonable and untenable, especially when the policy is worded broadly to be inclusive of smoking-related items not limited to lighters.

Moreover, as explained in the ALJ Decision and our discussion earlier, even accepting that staff had no reason to think R5 had a lighter, Petitioner nevertheless had an obligation to supervise R5’s smoking, which it did not do on the evening of January 14.  Indeed, the purpose of the policy, “to maintain safe resident smoking practices,” in Petitioner’s own words (RR at 3), would be best served by having staff monitor the possession and use of all smoking materials.  That would be particularly true for individuals like R5, whom staff had already determined as needing the facility to store his cigarettes and lighter as well as direct supervision when smoking.  CMS Ex. 10, at 41.   

Petitioner also says it would be “impossible” for any facility to provide “24-hour” one-on-one supervision – something not mandated by any rule or regulation and which could invade a resident’s right to privacy – to all residents determined to need supervision.  RR at 3.  Petitioner’s argument misses the mark.  The ALJ did not conclude that Petitioner violated section 483.25(d) because it did not provide 24-hour one-on-one supervision of R5; the ALJ held Petitioner to taking reasonable steps to prevent the foreseeable risk of harm posed by R5’s smoking activity and possession of cigarettes.  Those steps included direct supervision of R5 while he had smoking materials in his possession – something Petitioner itself determined was appropriate to mitigate the risk of harm for all residents without independent smoking privileges.  Cf. Azalea Court, DAB No. 2352, at 9-10 (rejecting argument that section 483.25(h) does not require continuous one-on-one supervision where the facility itself made observation of the resident’s whereabouts “at all times” part of the resident’s care plan). 

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II.   There is a basis to impose a CMP; CMS’s immediate jeopardy finding is not subject to review; Petitioner has not identified any basis to eliminate or reduce the CMP amount.  

As discussed earlier, noting that the $20,905 per-instance CMP was “close to” the maximum permissible per-instance CMP amount, the ALJ determined that the CMP was reasonable in light of the seriousness of, and Petitioner’s culpability for, the deficiency.  ALJ Decision at 15-17.  The ALJ considered, but rejected, Petitioner’s argument that the CMP amount was excessive.  Id. at 16. 

On appeal, Petitioner says nothing about the ALJ’s determination upholding the CMP amount.  It does, however, ask that we “reverse” the ALJ’s decision to grant summary judgment for CMS on the section 483.25(d) deficiency, the only deficiency at issue and the only basis for the imposition of the $20,905 CMP, as erroneous.  RR at 1.  We understand Petitioner to be asserting that there is no basis for finding noncompliance with 42 C.F.R. § 483.25(d) and thus no basis for the imposition of any CMP.  As explained, the undisputed material facts establish that Petitioner was not substantially compliant with 42 C.F.R. § 483.25(d).  Accordingly, there is a basis to impose a remedy, which may be a CMP for an instance of noncompliance.  In the absence of any argument by Petitioner challenging the CMP amount, we have no reason to disturb the ALJ’s determination that the CMP is reasonable and, therefore, it is summarily affirmed.16 

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Conclusion

We affirm the ALJ Decision.

• 1. On October 4, 2016, CMS issued a final rule that amended the Medicare participation requirements for long-term care facilities published in 42 C.F.R. Part 483.  Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016).  CMS applied the revised regulations in citing Petitioner.  Our analysis and decision are based on the participation requirements in effect when the survey supporting CMS’s enforcement action was performed.  Carmel Convalescent Hosp., DAB No. 1584, at 2 n.2 (1996) (applying the regulations in effect on the date of the survey and resurvey).
• 2. Facility records reflect variations in how some staff members are referred.  For instance, they also identify STNA Hampshire as a “CNA” (Certified Nursing Assistant).  CMS Ex. 10, at 61.  These variations present no issue affecting our analysis.
• 3. The ALJ noted an apparent discrepancy concerning when STNA Hampshire observed R5 going outside to the smoking area.  ALJ Decision at 9 n.8.  According to the survey records, STNA Hampshire made her observation at 3:30 p.m.; however, in her affidavit, STNA Hampshire stated she made her observation “shortly after lunch, not 3:30 p.m.”  Id.; compare CMS Exs. 15, at 11 and 23, at 2 and CMS Ex. 10, at 49 (¶ 12).  The ALJ stated that the exact time at which staff observed R5 smoking outside on January 14 was not material to her decision.  ALJ Decision at 9 n.8.
• 4. The ALJ noted CMS appeared to have conceded that staff performed a room sweep while R5 was smoking outside in the afternoon of January 14.  ALJ Decision at 10 n.9 (citing CMS Br. at 6).  The record evidence does not establish when the room sweep occurred or that CMS conceded that it occurred while R5 was smoking outside; however, the exact timing of the room sweep is immaterial and we accept that it occurred after STNA Hampshire learned R5 was refusing to relinquish his cigarettes.  The ALJ also noted that, in asserting that staff began 30-minute checks on R5 after 7 p.m., Petitioner relied on LPN J. Meade’s affidavit (P. Ex. 5), which the ALJ had excluded as filed late and without good cause.  Id. n.10 (citing P. Br. at 7).  “Nevertheless,” the ALJ said, “for purposes of summary judgment, I accept that Petitioner’s staff implemented 30-minute checks on R5.”  Id.
• 5. Survey findings are described in CMS Form 2567, Statement of Deficiencies (SOD), which identifies noncompliance findings using “Tag” designations that correspond to the participation requirements at issue and CMS’s guidance on the requirements.  See generally CMS Pub. 100-07, State Operations Manual, Chapter 7, Survey and Enforcement Process for Skilled Nursing Facilities and Nursing Facilities.  The Manual and Appendices to the Manual are available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.
• 6. CMS also cited, but did not impose a remedy for, a non-immediate-jeopardy deficiency alleging a violation of 42 C.F.R. § 483.90(i)(4) (Tag F925) for failure to maintain an effective pest control program.  CMS Ex. 9, at 1-3; CMS Ex. 15, at 13-18.  Petitioner sought to challenge the Tag F925 deficiency before the ALJ, but the ALJ determined she had no authority to review that deficiency because CMS did not impose a remedy.  ALJ Decision at 14-15 (“The remedy, not the citation of a deficiency, triggers the right to a hearing.”).  Since Petitioner’s appeal before the Board is limited to Tag F689 (Request for Review at 1), we need not address this aspect of the ALJ Decision.
• 7. We note two things about the written testimony.  First, although the ALJ excluded LPN Meade’s February 16, 2019 affidavit (P. Ex. 5), the ALJ admitted a different affidavit signed by LPN Meade on August 8, 2018.  See CMS Ex. 10, at 56-57.  Second, the ALJ determined the written direct testimony of Maintenance Manager Tucker (CMS Ex. 10, at 52-53) was irrelevant because it concerned the non-reviewable pest-control deficiency.  ALJ Decision at 3 n.2.  Although the ALJ admitted CMS Ex. 10, she excluded Tucker as a witness and, therefore, did not consider the part of CMS Ex. 10 containing his affidavit.  Id. (“It is not practicable to exclude a portion of CMS Ex. 10.  However, I do not consider pages 52-53 of CMS Ex. 10 in reaching my decision.”).
• 8. The parties disputed whether staff knew that R5 had a lighter.  CMS asserted that staff knew R5 had a lighter, as well as cigarettes; Petitioner did not dispute that staff knew R5 had obtained cigarettes from a visitor but denied knowledge of whether R5 also had a lighter.  For purposes of ruling on CMS’s motion, the ALJ accepted that staff were not aware R5 had a lighter in his possession.  ALJ Decision at 9.  In any case, the ALJ also stated, whether staff knew R5 had a lighter was ultimately immaterial.  Id.
• 9. The ALJ noted the SOD indicated that three staff members were unable to confirm whether a room sweep was completed, but also that CMS appeared to have conceded that a room sweep was completed.  For purposes of the summary judgment analysis, the ALJ assumed that staff had completed a room sweep.  ALJ Decision at 10 n.9 (citing CMS Ex. 15, at 10-11; CMS Ex. 23, at 2; CMS Br. at 6).
• 10. During the survey, a surveyor noted that a “portable oxygen tank was affixed to the back of [R5’s] wheelchair.”  ALJ Decision at 16 (citing CMS Ex. 23, at 2).  Petitioner, the ALJ said, did not dispute that the oxygen played a role in igniting a fire.  Id. (citing P. Br. at 7 (acknowledging that “the oxygen started a fire”)).  Before the Board, Petitioner does not challenge this aspect of the ALJ’s analysis.
• 11. Before 2016, the text of 42 C.F.R. § 483.25(d)(1) and (d)(2) was codified in prior sections 483.25(h)(1) and (h)(2), as the ALJ noted.  ALJ Decision at 7 n.6 (citing Final Rule, Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68,688, 68,828 (Oct. 4, 2016)).  We agree with the ALJ that it is appropriate to rely on the reasoning in Board decisions interpreting prior sections 483.25(h)(1) and (h)(2) because there was no substantive change to the language when those sections were re-codified in sections 483.25(d)(1) and (d)(2).  See id.
• 12. “The plain meaning of the term ‘accident hazards’” (as used in former section 483.25(h)(1) and in current section 483.25(d)(1)) “encompasses the hazard of accidentally starting a fire.”  Glenburn Home, DAB No. 1806, at 3, 25-26 (2002).  The risk of accidental fire from smoking is self-evident.  Petitioner does not dispute that a resident’s unsupervised smoking in a nonsmoking area (with oxygen via nasal cannula) posed a foreseeable risk of harm.  Nor does Petitioner dispute that R5’s smoking after the supervised smoke break on January 14 and the accident that occurred that evening were foreseeable.
• 13. Petitioner takes issue with what it characterizes as the “claim” “on hindsight” that 30-minute checks were insufficient to keep R5 safe.  It says, “no one has stated that [the accident] would not have happened if R5 had been directly supervised.”  RR at 3.  The question of whether a facility violated section 483.25(d) does not turn on the occurrence of an accident; the issue is whether the facility took all reasonable steps to protect residents from foreseeable risks of harm, which Petitioner did not do in this instance.  See, e.g., Western Care Mgmt. Corp.,DAB No. 1921, at 15 (2004).
• 14. The “Board has routinely rejected attempts to import [common law] tort principles into federal administrative proceedings involving long-term care facilities.”  Kindred Transitional Care and Rehab – Greenfield, DAB No. 2792, at 12 (2017) (and cited cases).
• 15. The State Operations Manual, Appendix PP, “Interpretive Guidelines for Long-Term Care Facilities,” Revision 173 dated November 22, 2017, is available at:  https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf.
• 16. Where, as here, CMS has decided to impose a per-instance CMP, the penalty amount must be in the range set by regulation regardless of whether the noncompliance was at the “immediate jeopardy” level.  42 C.F.R. §§ 488.438(a)(2), 488.408(d)(1)(iv).  Petitioner did not ask us to review the “immediate jeopardy” determination and, in any event, the “immediate jeopardy” finding is not reviewable because it did not and could not affect the penalty range for this CMP.  See Fort Madison Health Ctr., DAB No. 2403, at 12-13 (2011).