Opinion ID: 786733
Heading Depth: 5
Heading Rank: 3

Heading: The Alleged Disputes Regarding Patient Care

Text: 42 The most serious potential genuine disputes of material fact concern the care of four patients at Crestview's facility (Residents 44, 68, 90, and 93). For Residents 44 and 90, Crestview allegedly failed to provide the necessary care and services to attain or maintain the highest practicable physical, mental, or psychosocial well-being, in accordance with the comprehensive assessment and plan of care. 42 C.F.R. § 483.25. The ODH surveyors observed Residents 44 and 90 without elbow and heel protectors at multiple times during the days of observation, even though physicians had ordered the protectors to be worn at all times because of the high danger of pressure-sore development. 2 Crestview responds by arguing: 1) the residents did not need the protectors because the protectors would not prevent the development of unavoidable sores and because other treatments, such as the use of pressure-relief mattresses, were employed to prevent the development of sores; and 2) the protectors were not observed on the patients because the residents moved, shifted, or displaced the protectors or because the protectors were removed by staff to provide treatment. J.A. at 252-54 (Pet. Prehearing Br.); J.A. at 264-65 (Hrybiniak Decl.). We emphatically reject Crestview's first argument. Crestview cannot defend an alleged failure to adhere to a physician's orders by contending that those orders are incorrect or misguided. If the staff of a facility believes that a resident does not need protectors or some other treatment ordered by a physician, the proper course of action is to rework the patient's comprehensive plan of care in a venue other than HHS's administrative appeals process. Barring such revision, a facility must follow the plan of care. 43 Crestview's second argument is different, because it posits that the patients themselves interfered with the implementation of a physician's order. Crestview did not dispute that the protectors were not on the residents, but rather presented evidence, solely in the form of an administrator's affidavit, that it did not violate § 483.25 because the residents moved or shifted the protectors, the residents were uncooperative with care, or the staff removed the protectors to provide other treatment. This evidence suggests not that the doctor's orders were inappropriate, but rather that Crestview did not fully execute them because of patient interference or because of the necessity of other intervening treatments. Consequently, we must assess whether the mere fact that the surveyors saw two patients without heel protectors, which were supposed to be worn at all times, by itself is a violation of § 483.25. In other words, is Crestview strictly liable such that it cannot offer reasons for the observed deviations from the comprehensive plan of care? 44 There is, unfortunately, not a clear answer. In our lone case evaluating § 483.25, Woodstock Care Ctr. v. Thompson, 363 F.3d 583 (6th Cir.2003), we noted that the HHS DAB did not employ a strict-liability standard when evaluating whether a provider achieved compliance under a subsection of § 483.25, which required a facility to ensure that ... [e]ach resident receives adequate supervision and assistance devices to prevent accidents. Id. at 589 (quoting 42 C.F.R. § 483.25(h)(2)). We affirmed the DAB's imposition of a penalty. Id. at 590. In the administrative decision below, the DAB had held that the regulatory standard does not amount to strict liability or require absolute success in an obviously difficult task ... [and] that an element of reasonableness is inherent in the regulation's requirements. Woodstock Care Ctr. v. Health Care Fin. Admin, Docket No. A-2000-32, CR 623, DAB No. 1726, 2000 WL 900609 (H.H.S.), at 19 (May 30, 2000) (quotation omitted). Subsequent DAB decisions have confirmed this holding as it applies to § 483.25(h)(2), the regulation governing accident prevention. Josephine Sunset Home v. CMS, Docket No. A-03-85, CR 1038, DAB No.1908, 2004 WL 714959, at 10 (Feb. 9, 2004) (affirming Woodstock and listing other cases that decline to impose strict liability). At least one ALJ has also ruled that strict liability does not control § 483.25(m)(2). See Living Ctr. West v. CMS, Docket No. C-00-844, CR 988, 2002 WL 31906315 (H.H.S.), at 9 (Dec. 18, 2002) (ruling that [a]bsent ... a regulation or ruling of strict liability for any `missed dose' under 42 C.F.R. § 483.25(m)(2), the factual circumstances of the deficiency must be considered). 45 The lack of strict liability in § 483.25(h) does not automatically mean that a violation of the general language of § 483.25 is not a strict-liability infraction, but the use of the word practicable in § 483.25 suggests that a party can offer reasons for the failure to adhere to a comprehensive plan of care. The regulation employs the phrase highest practicable physical, mental, and psychosocial well-being, 42 C.F.R. § 483.25 (emphasis added), which suggests that a reasonableness standard inheres in the regulation. Similar to the word adequate in § 483.25(h)(2), practicable intimates that it is possible for a petitioner to show that there was a justifiable reason for the violation of § 483.25. 3 Lacking any other guidance from HHS aside from its statements in Woodstock and progeny, we conclude that § 483.25 is not a strict-liability regulation. 46 Crestview has presented some evidence that Residents 44 and 90 were observed without their ordered skin protectors because the residents removed or shifted the protectors or the staff members removed the protectors to provide other treatment. Crestview's evidence in this vein is not strong, chiefly because Crestview has failed to point to any patient records or preserved staff observations of such behavior, but the relative weakness of the evidence in comparison with the observations by the ODH surveyors is not a proper consideration on summary judgment. Upon remand, the ALJ may conclude in fact that Crestview has not proven it acted reasonably in failing to adhere to these residents' plans of care. Nonetheless, taking the evidence in the light most favorable to Crestview, a genuine dispute of material fact exists regarding the violation of § 483.25. Summary judgment without an in-person hearing on the issue of the asserted violations involving these two residents was thus improper. 47 For Residents 68 and 93, Crestview was cited for failing to prevent the development of avoidable new pressure sores and to provide the necessary treatment to promote healing of preexisting sores. 42 C.F.R. § 483.25(c)(2). To counter the observations of pressure sores on Resident 68, Crestview introduced evidence that Resident 68's pressure sores were clinically unavoidable. Crestview also asserted that Resident 68 rested on a pressure-relieving mattress to help avoid pressure sores and that the pressure sore observed on the left elbow was successfully treated within thirty days. J.A. at 254 (Pet. Prehearing Br.); J.A. at 265 (Hrybiniak Decl.). As regards Resident 93, Crestview presented evidence that the dirty protector reapplied to Resident 93's heel never made contact with his skin, because his foot was rebandaged, such that the allegedly dirty protector did not contribute to the development of any pressure sores. J.A. at 255 (Pet. Prehearing Br.); J.A. at 265 (Hrybiniak Decl.). Crestview did not offer any evidence to dispute the surveyor's observation that a dirty heel protector was earlier applied directly against Resident 93's open pressure sore before the nurse rebandaged the sore and placed the dirty protector against the clean bandage. 48 Crestview appears not to dispute that Resident 68 was not wearing heel protectors, but such a concession does not negate the existence of a genuine dispute of material fact. The evidence as presented, and taken in the light most favorable to Crestview, shows that Crestview took measures to halt the development of avoidable pressure sores and to promote the healing of existing sores. Crestview claims that the pressure sores were unavoidable and that it succeeded in treating other pressure sores affecting Resident 68. Whether these sores were unavoidable and whether Crestview succeeded in preventing and treating the sores are factual questions that should not have been resolved in a summary fashion without a hearing. CMS certainly presented evidence that Crestview violated 42 C.F.R. § 483.25(c)(2), but CMS's evidentiary effort with regards to Resident 68 only reinforces our conclusion that summary judgment (and thus disposition without a hearing) is improper in the face of disputes of material fact. 49 The same cannot be said of Crestview's evidence regarding Resident 93. Crestview has failed to dispute the surveyor's observation that a dirty heel protector had been applied directly against an open pressure sore. That the same dirty heel protector was later reapplied over clean bandages does not remedy the initial instance of unclean treatment of pressure sores. In evaluating Crestview's noncompliance with § 483.25(c)(2), the ALJ did not consider the appropriateness of applying the dirty heel protector to the resident's bandaged feet, but rather focused on the initial application of the protector to an open sore. Because Crestview failed to challenge this observation, there is no genuine dispute of material fact regarding the violation of § 483.25(c)(2) with regards to Resident 93. 50