SUBJECT: Lakeridge Villa Health Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

Lakeridge Villa Health Care Center (Lakeridge, Petitioner) appeals the October 14, 2004 decision by Administrative Law Judge (ALJ) Anne E. Blair sustaining the determination of the Centers for Medicare & Medicaid Services (CMS) to impose civil money penalties (CMPs) totalling $80,300 for Lakeridge's failure to substantially comply with Medicare participation requirements. Lakeridge Villa Health Care Center, DAB CR1231 (2004) (ALJ Decision).

As discussed below, we conclude that none of Lakeridge's arguments on appeal provides a basis for overturning the ALJ Decision. Accordingly, we sustain the CMPs imposed in this case.

Background

Lakeridge is a skilled nursing facility (SNF). SNFs participating in the Medicare program are subject to survey and enforcement procedures set out in 42 C.F.R. Part 488, Subpart E, to determine if they are in substantial compliance with applicable program requirements which appear at 42 C.F.R. Part 483, Subpart B. "Substantial compliance" means a level of compliance such that "any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301. "Noncompliance," in turn, is defined as "any deficiency that causes a facility to not be in substantial compliance." 42 C.F.R. � 488.301.

A CMP is one of the remedies that may be imposed against a facility that is not in substantial compliance. 42 C.F.R. � 488.408(d). A CMP in the range of $50-$3,000 per day may be imposed for one or more deficiencies that do not constitute "immediate jeopardy" but that either cause actual harm or create the potential for more than minimal harm. 42 C.F.R. � 488.438(a). A CMP in the range of $3,050-$10,000 per day may be imposed for one or more deficiencies that constitute "immediate jeopardy." 42 C.F.R. � 488.438(b). Immediate jeopardy is defined in 42 C.F.R. � 488.301 as "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." The regulations provide a number of factors to be considered by CMS in determining an appropriate CMP amount within the applicable range. 42 C.F.R. � 488.438(f)(3), incorporating by reference 42 C.F.R. � 488.404.

The Ohio Department of Health (State survey agency) conducted a complaint and standard survey at Lakeridge beginning on August 21, 1999 and ending on August 27, 1999, ⁽¹⁾ and issued a Statement of Deficiencies (SOD) that cited Lakeridge for numerous alleged deficiencies, one of which was categorized as immediate jeopardy. The State survey agency found that the immediate jeopardy abated on August 31 and that the deficiencies identified in the survey were corrected on October 3. CMS notified Lakeridge that it concurred with the State survey agency findings and would impose CMPs in the amount of $5,150 per day effective August 23-30, 1999, and in the amount of $1,150 per day from August 31-October 3, 1999.

Following a hearing, the ALJ concluded that Lakeridge had failed to substantially comply with five requirements of participation cited by the surveyors and that CMS did not make a prima facie case that Lakeridge failed to substantially comply with one participation requirement. ⁽²⁾ In addition, the ALJ found that the CMPs assessed against Lakeridge are reasonable. The ALJ also rejected several legal arguments made by Lakeridge.

On appeal, Lakeridge takes exception to the following numbered findings of fact and conclusions of law (FFCLs) made by the ALJ:

1. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25(h)(2).

a. Petitioner knew or should have known of the potential harm posed by incorrect use of restraints.
b. With respect to six residents, Petitioner failed to rebut CMS's prima facie case that the residents did not receive adequate supervision and assistance devices to prevent accidents.
c. Pursuant to regulations, as written and interpreted by the Departmental Appeals Board (Board), Petitioner failed to take reasonable measures to prevent foreseeable accidents.
d. The potential for more than minimal harm and, thus, Petitioner's substantial noncompliance, exists even though no actual injury occurred.
e. CMS's assessment that Petitioner's noncompliance with 42 C.F.R. � 483.25(h)(2) presented immediate jeopardy to Petitioner's residents is not clearly erroneous.

2. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.13.

a. With respect to seven residents, Petitioner failed to rebut CMS's prima facie case that Petitioner used restraints on the residents without adequate medical justification.
b. Use of restraints without medical justification presents the potential for more than minimal harm.

4. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25.

a. With respect to seven residents, Petitioner failed to rebut CMS's prima facie case that it did not provide the necessary care and services so that the residents could attain or maintain their highest practicable physical, mental and psychosocial well-being, in accordance with their comprehensive assessment and plan of care.
b. Petitioner's failure to provide necessary care and services presents the potential for more than minimal harm.

5. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25(c). a. With respect to four residents, Petitioner failed to rebut CMS's prima facie case that it did not ensure that residents who entered the facility without pressure sores did not develop them unless unavoidable and/or that residents with pressure sores received necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

b. The Petitioner's failure to provide services for the prevention and treatment of pressure sores presents the potential for more than minimal harm.

6. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25(d)(2).

a. With respect to six residents, Petitioner failed to rebut CMS's prima facie case that Petitioner did not ensure its residents received appropriate incontinence care treatment and services to prevent urinary tract infections and restore as much normal bladder function as possible.
b. Petitioner's failure to provide appropriate incontinence care and services to prevent urinary tract infections and to restore as much normal bladder function as possible caused either actual harm or the potential for more than minimal harm.

7. The CMPs assessed against Petitioner are reasonable.

8. Other arguments presented by Petitioner are not persuasive.

a. The correct standard for the burden of proof, as set forth in Hillman Rehabilitation Center, DAB No. 1611 (1997), has been reaffirmed and explained by the Board.
b. CMS may impose a CMP for a deficiency found while the facility is implementing an approved plan of correction for the same deficiency cited in a prior survey.
c. Petitioner was not denied a fair hearing due to evidentiary and procedural rulings I made during the course of this proceeding.
d. As stated previously, Petitioner could reasonably foresee accidents with its use of restraints and there were practicable methods available to Petitioner to provide adequate supervision and assistance devices.

ALJ Decision at 5-7, 12-15, 22-23, 25, 30-31, 35, 39-42.

Our standard of review on a disputed conclusion of law is whether the ALJ decision is erroneous. Our standard of review on a disputed finding of fact is whether the ALJ's finding is supported by substantial evidence on the record as a whole. See Guidelines for Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs, http://www.hhs.gov/dab/guidelines/ prov.html.

We first address Lakeridge's exceptions to the FFCLs on two cross-cutting legal issues (FFCLs 8.a. and 8.b.). We then address Lakeridge's exceptions to the FFCLs regarding the individual deficiencies on which the CMPs were based (FFCLs 1, 2, 4, 5, and 6). ⁽³⁾ Next, we address Lakeridge's exception to the FFCL regarding the reasonableness of the CMP amounts (FFCL 7). Finally, we discuss Lakeridge's exception to the FFCL affirming the ALJ's prior evidentiary and procedural rulings (FFCL 8.c.). ⁽⁴⁾

I. The ALJ did not err in allocating the burden of proof here.

In FFCL 8.a., the ALJ held that the correct standard of proof was set out in a Board decision holding that, before the ALJ, a rehabilitation facility must prove substantial compliance by the preponderance of the evidence, once CMS has established a prima facie case that the facility was not in substantial compliance with relevant statutory or regulatory provisions. Hillman Rehabilitation Center, DAB No. 1611, aff'd, Hillman Rehabilitation Center v. United States, No. 98-3789(GEB) (D.N.J. May 13, 1999). Lakeridge takes the position that the ALJ, in following Hillman, erroneously shifted the burden of proof to the provider. Lakeridge argues that requiring it to prove compliance by the preponderance of the evidence conflicts with the Administrative Procedure Act (APA) and also that the "burden of proof standard" applied here is a substantive rule that was not promulgated pursuant to the notice and comment rulemaking procedures required by the APA. RR at 3-6.

We reject Lakeridge's contention that placing the ultimate burden of persuasion on the facility to show substantial compliance violates the APA. As the Board has previously stated, the burden of proof that the Board applies is not a rule under the APA but instead is in the nature of an order setting forth a rationale, based on the statute and regulations, that establishes precedent for ALJ hearings in these cases. See, e.g., Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), aff'd, Batavia Nursing & Convalescent Ctr. v. Thompson, No. 04-3325 (6th Cir. Apr. 15, 2005). Furthermore, while this rationale was originally set forth in Hillman, it has not been treated as a binding rule but has been reexamined as appropriate to different types of cases. In subsequent decisions, the Board found that the same burden applied in cases involving nursing facilities such as Lakeridge. See, e.g., Cross Creek Health Care Center, DAB No. 1665 (1998). In any event, in a prior case, the Board held, and the court affirmed, that allocation of the ultimate burden of persuasion is material only where the evidence is in equipoise. Fairfax Nursing Home, Inc., DAB No. 1794 (2001), aff'd, Fairfax Nursing Home, Inc. v. U.S. Dept. of Health and Human Svcs., 300 F.3d 835, 840, n.4 (7th Cir. 2002), cert. denied, 537 U.S. 1111 (2003). To the extent that the evidence in this case is not in equipoise, it is immaterial where the burden lies.

We therefore affirm the ALJ's FFCL 8.a.

II. The ALJ did not err in ruling that CMS is authorized to base a CMP on a deficiency found while the facility is implementing an approved plan of correction for the same deficiency cited in a prior survey.

In FFCL 8.b., the ALJ affirmed her April 30, 2002 ruling that CMS is authorized to base a CMP on a deficiency found while the facility is implementing an approved plan of correction for the same deficiency cited in a prior survey. CMS based the $5,150 per day CMP at issue here in part on its finding, based on the August 1999 survey, of an immediate jeopardy deficiency under section 483.25(h)(2), cited in the SOD as Tag F-324. This deficiency citation related to findings (discussed later in this decision) that Lakeridge failed to ensure that restraints were applied properly or that residents with restraints were supervised properly to prevent accidents. In a prior complaint survey, conducted on July 30, 1999, the State survey agency found a deficiency under the same tag, based on a finding that Lakeridge did not assure adequate supervision for a resident who left the facility for a workshop away from the facility. The deficiency found in the prior survey was cited at a scope and severity level of "E" (a pattern of no actual harm with a potential for more than minimal harm that is not immediate jeopardy). The State survey agency gave Lakeridge until September 18, 1999 to correct this deficiency.

An ALJ previously assigned to the instant case raised the issue of whether CMS could properly impose a CMP based on the citation to Tag F-324 in the August 1999 survey since the period for correction of a deficiency cited under that tag pursuant to the July 1999 survey had not ended. Pre-Hearing Conference Summary and Confirmation of Briefing Schedule, dated 10/19/00. Following briefing by the parties, ALJ Blair ruled that "a CMP could be based on the August 27^th survey, even though it occurred during a period when Petitioner had an accepted plan of correction . . . ." Ruling and Notice of Hearing dated 4/30/02, at 4-5. ⁽⁵⁾ Lakeridge notified the ALJ that it objected to this ruling and reserved the issue for appeal. Notice of Objections to Order of Administrative Law Judge, dated 5/2/02, at 1. On appeal, Lakeridge points out that the regulations at 42 C.F.R. � 488.412(a)(2) gave CMS the option of terminating Lakeridge's provider agreement or permitting Lakeridge to continue participation while implementing its plan to correct the non-immediate jeopardy deficiency under Tag F-324 found in the July 1999 survey. According to Lakeridge, in selecting the latter option, CMS need not have accepted the timeframe for correction proposed by the facility but could have required Lakeridge to take action within a specified timeframe. Lakeridge asserts, however, that both the State survey agency and CMS accepted the date Lakeridge proposed for correction of the identified deficiencies. Lakeridge argues that, having accepted this date, CMS could not properly base the CMP upon a finding of noncompliance for which Lakeridge was in the process of implementing its plan of correction. RR at 28-29.

A "deficiency" is a failure to meet a participation requirement. 42 C.F.R. � 488.301. The mere fact that a later failure is with respect to the same participation requirement (and therefore cited under the same survey tag number) does not mean that it is the same "deficiency." Here, the failure cited in the August 1999 survey is different in nature from the failure cited in the July 1999 survey and would require different corrective action. Thus, we question whether the two identified failures under the same tag should be considered to be the same deficiency. Even assuming that the two failures constituted the same deficiency, however, Lakeridge's reliance on section 488.412 is misplaced. This regulation states in pertinent part:

(a) If a facility's deficiencies do not pose immediate jeopardy to residents' health or safety, and the facility is not in substantial compliance, CMS or the State may terminate the facility's provider agreement or may allow the facility to continue to participate for no longer than 6 months from the last day of the survey if-
(1) The State survey agency finds that it is more appropriate to impose alternative remedies than to terminate the facility's provider agreement;
(2) The State has submitted a plan and timetable for corrective action approved by CMS . . . .

The regulation permits CMS to allow a facility with deficiencies to continue to participate in Medicare for up to six months if it has an approved plan of correction. Nothing in the regulation suggests, however, that CMS may not impose a remedy such as a CMP during the period for corrective action specified in such a plan. In any event, these regulations apply only to the situation where a facility's deficiencies do not pose immediate jeopardy. Here, the surveyors determined at the August 1999 survey that the deficiency under Tag F-324 posed immediate jeopardy from August 23-30. Section 488.410(a) requires that when there is immediate jeopardy, CMS terminate the provider agreement within 23 calendar days of the last date of the survey if the immediate jeopardy is not removed. Pursuant to section 488.410(b), CMS "may also impose other remedies, as appropriate." There is no mention in section 488.410(b) of a plan of correction.

Thus, there is nothing in the regulations that precludes the imposition of a CMP based on a continuing deficiency before the facility has an opportunity to correct that deficiency pursuant to its approved plan of correction. Moreover, we agree with the ALJ that it was reasonable for CMS to impose a CMP notwithstanding the plan of correction since CMS found that the noncompliance cited at the August survey was more serious. If a CMP were held in abeyance pending the completion of the corrective action period, Lakeridge would have had no incentive to act quickly to correct a deficiency that posed immediate jeopardy to resident health and safety. Furthermore, as the ALJ pointed out, if CMS could terminate Lakeridge's provider agreement based on the August survey, it surely could impose a CMP on the same basis.

We therefore affirm the ALJ's FFCL 8.b.

III. The ALJ properly concluded that Lakeridge did not substantially comply with section 483.25(h)(2).

Section 483.25(h)(2) falls under the general "quality of care" requirement at section 483.25, and provides:

Accidents. The facility must ensure that-

* * * * * * *

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

The ALJ concluded in FFCL 1 that Lakeridge did not provide adequate supervision and assistance devices to prevent accidents in the case of the six residents cited in the SOD, in violation of section 483.25(h)(2). Lakeridge used restraints on each of these residents. The ALJ found that Lakeridge either used the restraints incorrectly and/or provided inadequate supervision for the resident. According to the ALJ, accidents were reasonably foreseeable under these circumstances because the restraint manufacturer provided instructions stating that serious complications of chest compression can result from incorrect application of the restraints (i.e., tying restraints to the non-movable part of a bedframe and using them with siderails not in position) as well as that additional supervision is required for residents wearing the restraints. ⁽⁶⁾ The ALJ also concluded that Lakeridge failed to substantially comply with section 483.25(h)(2) despite the lack of actual harm since noncompliance exists where there is a potential for more than minimal harm. Finally, the ALJ concluded that CMS's determination that Lakeridge's noncompliance with section 483.25(h)(2) presented immediate jeopardy to Lakeridge's residents was not clearly erroneous. ALJ Decision at 12-15.

Lakeridge first challenges this FFCL on procedural grounds. Lakeridge asserts that the ALJ erred in permitting CMS to amend its pleadings orally to include Tag F-324, the tag number corresponding to the finding in the SOD that involves this regulation. ⁽⁷⁾ Lakeridge relies on the fact that a May 2, 2003 CMS letter listing the survey findings for which CMS would present evidence at the hearing scheduled to begin on May 13 did not list Tag F-324. Lakeridge alleges that it reasonably concluded from this letter that CMS was dropping this tag and therefore "withdrew numerous exhibits" and "did not call all of its intended witnesses." RR at 8-9.

The ALJ Decision notes that Lakeridge had argued at the hearing that CMS's allegations under this tag should have been dismissed based on CMS's May 2 letter. The ALJ Decision states, however, that the letter referred to Tag F-323, that this "was clearly a typographical error" and that CMS intended to refer to Tag F-324 instead. The ALJ relied on the fact that the SOD did not include a Tag F-323, as well as the fact that Tag F-324 was the immediate jeopardy tag and "CMS did not suggest it was dropping the tag for which it had assigned immediate jeopardy." ALJ Decision at 6. The ALJ Decision observes that Lakeridge could have asked for clarification if it was confused about CMS's intentions after the letter, but did not. In addition, the ALJ Decision states that Lakeridge had ample opportunity to call additional witnesses and submit further exhibits after the ALJ ruled at the hearing not to dismiss this tag. The ALJ therefore reaffirmed her ruling on the ground that Lakeridge was relying on "an obvious typographical error for which Petitioner has shown no prejudice." Id.

We conclude that Lakeridge's exception has no merit. We agree with the ALJ that CMS intended to refer to Tag F-324 rather than Tag F-323 in its May 2 letter. There appears to be no logical reason why CMS would have dropped its immediate jeopardy tag after discussing it in its prehearing brief. See CMS Pre-Hearing Memorandum dated 9/30/02, at 14-18. The Board has previously held that it "will not countenance the purely formalistic claim that a typographical mistake must defeat evaluation of the evidence on . . . noncompliance with the regulation." Beechwood Sanitarium, DAB No. 1906, at 43 (2004) (finding that Beechwood had adequate notice of the requirements at issue, despite a typographical error in the SOD).

We also agree with the ALJ that Lakeridge was not prejudiced by this typographical error. The gravamen of Lakeridge's objection is that it was denied "notice and an opportunity to be heard." RR at 8. However, Lakeridge's counsel raised this issue at the outset of the hearing and was promptly advised of the ALJ's conclusion that it was clear that CMS was relying on Tag F-324. Tr. at 10-12. Even if Lakeridge was unprepared to offer exhibits or present testimony relating to this tag during the time scheduled for the hearing (which ended a day and a half early because Lakeridge presented only one witness), Lakeridge could have requested a continuance of the hearing. Instead, Lakeridge's counsel merely asked "for a continuing objection to testimony and exhibits regarding tag 324 . . . ." Id. at 12. Moreover, CMS asserts, and Lakeridge does not dispute, that the proposed exhibits that Lakeridge did not offer at the hearing related to deficiencies other than Tag F-324, further undermining Lakeridge's claim that it was deprived of an opportunity to make its case with respect to this tag. See CMS Response Br. at 12, n.4. Finally, neither before us, nor when objecting to the ALJ ruling, did Lakeridge make any proffer of evidence that it would have presented but for CMS's typographical error.

Lakeridge also disputes FFCL 1.c., arguing that the ALJ erred in upholding the deficiency finding "regardless of whether or not the accident actually does occur or results in any harm." RR at 12. ⁽⁸⁾ Lakeridge mischaracterizes the ALJ Decision, however. While the ALJ Decision cites the statement in Koester Pavilion, DAB No. 1750 (2000), that the facility is required to do everything in its power to prevent accidents (which, taken out of context, may be somewhat misleading), the ALJ in fact applied the correct standard. The Board has previously described this standard as follows:

As indicated, section 483.25(h)(2) provides that a facility "must ensure" that "each resident receives adequate supervision and assistance devices to prevent accidents." In Woodstock Care Center, the Board analyzed the wording, context, and history of section 483.25(h)(2) and, based on that analysis, set out a framework for evaluating allegations of noncompliance with that requirement. Woodstock Care Center, DAB No. 1726, at 25-30 (2000)(citing 54 Fed. Reg. 5316, 5332 (February 2, 1989)), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). We determined that although section 483.25(h)(2) does not hold a facility strictly liable for accidents that occur, it does require the facility to take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents. Id.; see also Odd Fellow and Rebekah Health Care Facility, DAB No. 1839 (2002). A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must be adequate under the circumstances. See Woodstock Care Center. What are adequate supervision and assistance devices for a particular resident depends, of course, on the resident's ability to protect himself from harm. Id.

Northeastern Ohio Alzheimer's Research Center, DAB No. 1935, at 9 (2004). Lakeridge's suggestion that, in order to find a lack of substantial compliance with the regulatory requirement, the ALJ must find that an accident has occurred and that it resulted in harm ignores the context and statutory goal of the regulation. The purpose of the regulatory requirement is to prevent accidents, as part of achieving the statutory goal that residents attain or maintain their highest practicable level of functioning. Moreover, as noted above, the regulations make clear that no finding of actual harm is required since noncompliance exists if there is a potential for more than minimal harm.

In the context of determining whether the standard was met, the first issue is whether the services provided are consistent with the plan of care and comprehensive assessment of the resident, which reflect the facility's own evaluation of what is needed to prevent accidents. Resident 30's care plan as of July 8, 1999 included an alarm in bed to prevent falls, yet the surveyors observed the resident without a bed alarm in place on two occasions. CMS Ex. 8, at 30; CMS Ex. 3, at 83; ALJ Decision at 7-8. (In addition, the ALJ found that there was a physician's order for a bed alarm. ALJ Decision at 7, citing Tr. at 35-36.) This failure alone, which Lakeridge did not dispute, would be sufficient to find a lack of substantial compliance since Lakeridge itself had evaluated the resident as needing an alarm.

Where it is necessary to go on to evaluate the adequacy of the supervision and assistance devices planned for and in fact provided, the ALJ must consider whether the facility could have reasonably foreseen that an accident might occur in spite of the services provided (that is, that the facility knew or should have known that the services were inadequate to prevent accidents), including that the planned level of supervision was inadequate to meet the resident's needs or that an assistance device would not function as intended because, for example, the device was not properly applied to the resident. In the case of Residents 30, 29, 8, and 22, the surveyors found that a restraint was tied to the non-movable part of the bedframe, contrary to the manufacturer's instructions. ALJ Decision at 7-9, citing Tr. at 35-38, 68-69, 235, 239-240. In the case of Resident 74, the surveyors found that the vest restraint was too large for the resident's frame and was tied around the arms of the geri-chair and secured in a manner contrary to the manufacturer's instructions. ALJ Decision at 10, citing Tr. at 530-31, 534-35, and CMS Ex. 79, at 3. Lakeridge does not dispute these findings, but merely argues that it was improper to infer that tying the restraint to a non-movable part of the bed could harm the residents since there was no testimony or evidence that staff attempted "to move or change the position of the bed without first releasing or loosening the restraint." RR at 10. However, the ALJ stated, and Lakeridge does not dispute, that Lakeridge provided no evidence that staff was specifically trained not to raise the bedframe when the restraint was tied to a non-movable part of the bed. ALJ Decision at 13. Thus, there is substantial evidence in the record supporting the ALJ's conclusion that Lakeridge should have known that the services it provided were inadequate to prevent accidents.

Lakeridge also challenges the ALJ's finding that CMS's determination of immediate jeopardy was not clearly erroneous (FFCL 1.e.). The ALJ relied in part on the surveyors' observations and testimony regarding "the danger to the residents posed by Petitioner's incorrect application of restraints and inadequate monitoring . . . ." ALJ Decision at 15, citing as examples Tr. at 37-40, 73, 88-90, 223, 231-234, 529-532 (pertaining to Residents 30, 29, 74 and 8). The ALJ also relied on the manufacturer's warnings about restraint application, which as the ALJ noted earlier, state that "[t]he inappropriate and/or incorrect application of restrictive products may result in serious injury or death." ALJ Decision at 14, citing CMS Ex. 79; see also ALJ Decision at 7. In addition, the ALJ pointed out that both the manufacturer's instructions and a Food & Drug Administration bulletin regarding potential hazards with protective restraint devices indicated that the circumstances and manner in which Lakeridge used a restraint on Resident 74 could result in serious harm (i.e., "chest compression and suffocation" and "fractures, burns and strangulations"). ALJ Decision at 15, citing CMS Ex. 79, at 6 and 7.

Lakeridge's only basis for challenging this FFCL is that it had a physician's order to use a vest restraint on Resident 74. RR at 13. Even if the physician's order was sufficient to show that a vest restraint was an appropriate intervention for this resident, however, the existence of such an order does not undercut the surveyors' observations that the restraint was the wrong size and was applied incorrectly, nor does it undercut the ALJ's findings regarding the danger this posed to the resident. Moreover, in determining that Lakeridge's noncompliance posed immediate jeopardy, the ALJ also relied on the surveyors' testimony regarding the danger posed to residents other than Resident 74 by Lakeridge's incorrect application of restraints and inadequate monitoring. Lakeridge does not challenge the ALJ's reliance on this testimony.

We therefore affirm the ALJ's FFCL 1.

IV. The ALJ properly concluded that Lakeridge failed to substantially comply with section 483.13(a).

Section 483.13(a) provides in pertinent part:

Restraints. The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms. ⁽⁹⁾

In FFCL 2, The ALJ found that Lakeridge failed to rebut CMS's prima facie case that Lakeridge used restraints on seven residents without adequate medical justification. The ALJ relied on surveyor testimony that, in each case, there were other, less restrictive measures that could have been used to ensure the resident's safety. The ALJ found that Lakeridge "did not present any evidence that it had analyzed whether less restrictive methods could have been used with these residents nor any evidence from a medical expert that the restraints were required to treat the residents' symptoms," the nature of which was undisputed by CMS. ALJ Decision at 22. According to the ALJ, "the facility should be able to provide affirmative evidence that a thoughtful interdisciplinary assessment of restraint use for a resident was done prior to calling the resident's physician to request an order for a restraint." Id. The ALJ also found that the hip fracture which had made a restraint necessary for Resident 29 had healed several months before the survey; that the testimony of Lakeridge's witness, licensed practical nurse (LPN) Pamela Griffin, regarding Resident 8, 60 and 62 suggested that, in each case, the restraint was used for staff convenience rather than for the resident's safety; that the family's request for a restraint did not itself justify the use of a restraint on either Resident 16 or Resident 73; and that a physician's order alone did not justify the use of a restraint in the case of Residents 16 or 73. Id. at 15-22. The ALJ further found that use of the restraints without medical justification presents the potential for more than minimal harm since it can cause not only physical injury but also mental anguish. Id. at 22-23.

Lakeridge argues that the ALJ simply restated the findings of the surveyors without any analysis of the regulation and that she adopted "the faulty argument of CMS that there is nothing in the resident records which identifies a 'medical symptom' for the use of a restraint." RR at 14. Citing Steadman's Medical Dictionary, 26^th Ed., pp. 17-18, Lakeridge notes that the word "symptom" is broadly defined. Lakeridge asserts that the record shows that medical symptoms existed to support the use of restraints in the case of each of the residents. Lakeridge claims, moreover, that it reasonably relied on physicians' orders to use restraints on Residents 30, 29, 8, 16 and 73. RR at 14-17.

Contrary to what Lakeridge argues, the ALJ's conclusions are based on the requirements of the regulation. In Cross Creek Health Care Center, which the ALJ cited, the Board stated that section 483.13(a) "imposes on nursing facilities, not doctors, an obligation to use restraints in a very prescribed manner -- not for discipline, not for convenience and only if required by the resident's medical symptoms." At 11 (also quoting the statement in 59 Fed. Reg. 56,116, 56,227 (Nov. 10, 1994) that "it is the facility's responsibility to ensure that the services provided by physicians will satisfy the facility's obligations under the Act and regulations"). ⁽¹⁰⁾ The Board also noted in that decision that "nursing facilities are subject to other Medicare/Medicaid requirements which are also not applicable to doctors and which could impact on a decision under section 483.13(a) to use or not use restraints." Id. Examples cited by the Board include the following: a long-term care facility is required to consult with the resident or the resident's surrogate about all treatment decisions (42 C.F.R. � 483.10(d)(2)); a long-term care facility is required to help a resident achieve his/her highest practicable physical, mental and psychosocial well-being (section 1819(b)(2) of the Social Security Act); and a long-term care facility resident has a right to refuse medical treatment (42 C.F.R. � 483.10(b)(4)). The Board concluded that, because section 483.13(a) is directed towards nursing facilities, "the regulation imposes on the long-term care facility an independent obligation to ensure that the use of restraints, even with a doctor's order, meets the criteria of the regulation" and "an independent obligation to continue to assess the impact of the use of a restraint and to consult with the doctor if the nursing facility finds that use of the restraint no longer meets the criteria of the regulation." Id. Thus, although a physician's order for a restraint is clearly some evidence of its medical necessity, such an order is not by itself sufficient to establish that use of the restraint met the criteria of the regulation.

While Lakeridge's request for review focuses on the physicians' orders, Lakeridge also submitted restraint assessments for five of the seven residents at issue. See P. Ex. 11, at 1 (5/26/99 assessment for Resident 73); P. Ex. 11, at 7 (5/13/99 assessment for Resident 8); P. Ex. 11, at 22 (11/1/98 assessment for Resident 30); P. Ex. 11, at 33 (12/10/98 assessment for Resident 16); and P. Ex. 44, at 53 (8/12/99 assessment for Resident 60). ⁽¹¹⁾ The assessments show that Lakeridge considered less restrictive alternatives for treating each of the five residents' medical symptoms before determining that restraints were necessary. The resident's right to be free from restraints if they are not required places an obligation on the facility to consider less restrictive alternatives to treat the resident's symptoms and to weigh the risks of restraint application against the benefits. Thus, the assessments are probative evidence that Lakeridge's use of the restraints met the criteria of the regulation.

The ALJ Decision implies that these assessments were not entitled to any weight because they were signed only by LPN Griffin and/or another nurse, not by an interdisciplinary team. However, the regulations do not specifically state that the assessment (or periodic reassessment) of whether to apply a restraint must be done by an interdisciplinary team (nor is there any statement to this effect in the SOM). ⁽¹²⁾ The ALJ also appeared to give no weight to the physicians' orders. The ALJ relied instead on surveyor testimony that the restraints were not required and that specific, different alternatives should have been tried first, but were not. Even if we were to conclude that giving proper weight to the assessments and physicians' orders would make a difference for some of the seven residents cited in the SOD, however, that would not be a basis for overturning the ALJ's finding of noncompliance with respect to at least four residents. We conclude that there is substantial evidence in the record showing that Lakeridge failed to substantially comply with section 483.13(a) in the following respects:

• Lakeridge did not submit any evidence that it did an assessment before using restraints on Residents 29 or 62. ⁽¹³⁾
  
  
• Lakeridge did not remove Resident 29's restraint even after the justification for the restraint no longer existed. The ALJ found that a soft waist restraint that was ordered for the resident on January 4, 1999, after she had suffered a hip fracture, was still being used at the time of the survey although the resident had been identified as a future candidate for restraint reduction in March 1999 and her hip fracture had healed by May 11, 1999. ALJ Decision at 17, citing Tr. at 53-54 and CMS Ex. 9, at 13. ⁽¹⁴⁾ To ensure that residents' rights to be free of restraint are respected, the facility may not reasonably continue to rely on a physician's order for a restraint that was based on a diagnosis or symptom that no longer exists, particularly given the risks of long-term use of restraints. ⁽¹⁵⁾
  

• The ALJ relied in part on the testimony of Surveyor Truett that "the use of a restraint with Resident 30 was actually unsafe because of her seizure disorder and posed a risk of injury if Resident 30 had a seizure with the restraint in place." ALJ Decision at 16, citing Tr. at 30. Lakeridge does not refer to this testimony or present any evidence to rebut it or to show that it had considered this particular risk and found that it was outweighed by the benefits of imposing the restraint.
  
  
• The SOD reports that Resident 73 was in a pelvic restraint for three hours without release of the restraint "even though the care plan for the resident stated for the resident to be walked every two hours when up." CMS Ex. 3, at 11. Lakeridge does not dispute these findings or provide any evidence to rebut them, but instead relies on the fact that there were physician's orders for the restraint. As the Board stated in Cross Creek Health Care Center, however, "review of a facility's compliance requires careful consideration to make sure that the facility is implementing the doctor's restraint order pursuant to its terms." At 11. Here, Lakeridge's use of the restraint was contrary to the physician's orders that Resident 73 be released from the restraint every two hours for 10 minutes. P. Ex. 43, at 27. In any event, Lakeridge had determined in Resident 73's plan of care that use of the restraint was justified only if the resident was walked every two hours.



• Lakeridge also failed to use restraints in accordance with Resident 62's plan of care. The SOD reports that Resident 62 was in a pelvic restraint for nearly four hours although the resident's plan of care indicated that the restraint should be released every two hours. CMS Ex. 3, at 12; see also, ALJ Decision at 21, citing CMS Ex. 16, at 5; P. Ex. 44, at 1. Lakeridge does not dispute these findings or point to any evidence to rebut them.
  

Had Lakeridge demonstrated for each resident in question that the resident's medical symptoms justified application and continued use of the restraint, the mere mention by LPN Griffin of family preferences and staff convenience would not by itself be sufficient to show violation of residents' rights. In the context of many instances where Lakeridge did not properly document justification for or proper use of restraints, however, LPN Griffin's testimony further calls into question whether Lakeridge had a policy consistent with the regulations.

Lakeridge also disputes the ALJ's finding that its noncompliance with section 483.13(a) presents the potential for more than minimal harm, asserting that "the use of restraint was limited to those residents whose medical condition required them . . . ." RR at 17-18. Lakeridge's argument has no merit, however. As discussed above, in the case of several of the residents at issue, Lakeridge failed to show that use of a restraint was warranted based on the resident's medical condition. Lakeridge does not dispute that use of a restraint where it is not warranted by the resident's medical condition has a potential for more than minimal harm. Moreover, Lakeridge's failure to apply the restraints in accordance with the physician's orders and/or the resident's plan of care in the case of two residents clearly posed the potential for more than minimal harm since the orders and care plans were intended to minimize the adverse effects of restraining the resident for a long period of time.

We therefore affirm the ALJ's FFCL 2.

V. The ALJ properly concluded that Lakeridge failed to substantially comply with section 483.25.

Section 483.25, captioned "Quality of care" provides in pertinent part:

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

This provision is based on the statutory definition of skilled nursing facility services in section 1819(b) of the Social Security Act. Following this lead-in language to section 483.25 are subsections addressing care and services to meet specific needs, such as prevention and treatment of pressure sores.

In FFCL 4, the ALJ found that Lakeridge had failed to provide services to seven residents to meet their identified needs and that this failure was inconsistent with the resident's plan of care, facility policy or physician's orders. The ALJ further found that Lakeridge's noncompliance presents the potential for more than minimal harm. ALJ Decision at 25-31.

Lakeridge's arguments are, for the most part, based on faulty legal premises. Lakeridge does not dispute that, as a general matter, a facility's failure to comply with physician's orders or to follow its own policy, as well as the failure to provide services in accordance with a plan of care based on a resident's comprehensive assessment, can constitute a deficiency under section 483.25. See The Windsor House, DAB No. 1942, at 55-56 (2004), citing Batavia Nursing and Convalescent Center at 35-36; Spring Meadows Health Care Center, DAB No. 1966, at 17-18 (2005). ⁽¹⁶⁾ Lakeridge argues, however, that a deficiency was not properly cited under tag 309 (corresponding to the lead-in language in section 483.25) where the findings relate to specific resident needs that are specifically addressed in subsections of section 483.25. According to Lakeridge, Resident 39 should have been cited under the tag for accidents, Residents 49, 74, and 50 should have been cited under the tag for pressure sores, and Resident 62 should have been cited under another, unspecified tag. RR at 19-22. However, as the Board indicated in Beechwood Sanitarium at 80, 89-90 (cited in the ALJ Decision at 30), the fact that CMS may have been able to cite a deficiency under another tag is irrelevant; the issue before us is whether the ALJ had substantial evidence in the whole record to support her factual findings and whether she committed legal error in evaluating those factual findings against the regulatory requirements under which the facility was cited. Lakeridge does not argue that the analysis or result would have been different here if CMS were relying on a subsection of section 483.25. Moreover, citing a deficiency under the general lead-in language of this section was particularly appropriate where Lakeridge's failure to meet the needs of the resident in question cut across more than one specialized need category, as in the case of Resident 50.

Lakeridge also argues, for some residents, that there was no actual harm to the residents, implying that this is a reason for overturning the finding of noncompliance as to these residents. For example, Lakeridge argues that, although Residents 49 and 50 were at risk for skin breakdown, Resident 49 never had a problem with skin breakdown and Resident 50 had no skin breakdown until August 25. RR at 21-22. As indicated in our discussion of FFCL 1, no actual harm is necessary to find noncompliance.

With respect to Resident 74, Lakeridge argues that the fact that CMS misidentified this resident on the SOD as Resident 73 means that any citation related to this resident should be stricken. Lakeridge's own plan of correction in response to the survey findings, however, indicates that Lakeridge was fully aware that the resident cited in the SOD, who was described there as having Huntington's Chorea, was Resident 74, not Resident 73 (who did not have Huntington's Chorea). CMS Ex. 3, at 43. Lakeridge does not assert, nor do we find, any prejudice to it from the mistake in the resident number on the SOD.

Lakeridge's arguments regarding the ALJ's factual findings also lack merit. For most of the residents at issue, Lakeridge does not dispute that it failed to provide care and services according to the plan of care, the facility's own policy, or physician's orders, ⁽¹⁷⁾ nor does Lakeridge cite to any evidence that it did in fact provide the services that the surveyors found it did not. ⁽¹⁸⁾ Instead, Lakeridge points mostly to evidence that is irrelevant to the ALJ's findings on these matters or that is undisputed. In the case of Resident 39, for example, the ALJ found that interventions in the resident's care plan to prevent falls were not implemented. ALJ Decision at 25-26. Lakeridge argues only that "[t]he plan of care listed interventions that addressed the specific needs of the resident," citing to exhibits containing care plans for the resident, and does not dispute the ALJ's finding. RR at 19.

With respect to Resident 50, Lakeridge does cite to evidence which, if credited, would show that, contrary to what the surveyor found, Lakeridge did, during the survey, apply gauze between the thumb and finger on the resident's left hand as required by a physician's order. RR at 22, citing P. Ex. 41. The evidence on which Lakeridge relies is a care record in which caregivers initialed that they provided these services at each of the three shifts on each of the survey dates. P. Ex. 41, at 12. The ALJ Decision acknowledges that Lakeridge provided this evidence, but also cites Surveyor Slusher's testimony that she did not see gauze on the resident's hand during the survey. ALJ Decision at 29, citing Tr. at 591. (The "surveyor notes worksheet" is consistent with this testimony. CMS Ex. 23, at 7.) The ALJ did not specifically state that she did not find Lakeridge's evidence credible; however, it is clear that the ALJ gave greater weight to the surveyor's testimony, which was consistent with the surveyor's notes, than to Lakeridge's care record. Since we find that it was not clear error for the ALJ to rely on the surveyor's testimony, particularly when Lakeridge did not present any testimony that the care record was correct, we defer to the ALJ's judgment in this matter.

The ALJ also appeared to base her conclusion that there was a deficiency under section 483.25 with respect to Resident 50 on a finding that Lakeridge did not provide range of motion exercises for this resident. ALJ Decision at 29. The record contains physician's orders for such exercises twice a day, three to five times a week. P. Ex. 41, at 9-10. Lakeridge argues that these services were provided. RR at 22, citing P. Ex. 41. The evidence on which Lakeridge relies is a care record with initials indicating that Resident 50 was given range of motion exercises twice a day, three times a week, during August 1999. P. Ex. 41, at 11. However, another document in that exhibit, captioned "Restorative Program Record," indicates that no range of motion exercises were provided from August 21 through August 31. Id. at 14. Moreover, the "surveyor notes worksheet" indicates that the surveyor asked facility staff on August 25 and 26 "to see ROM - but was never notified during the survey." CMS Ex. 23, at 7. In the absence of any testimony to resolve this conflicting evidence, the ALJ could reasonably find that the required services were not provided.

Lakeridge also disputes the ALJ's finding that its noncompliance "presents the potential for more than minimal harm," asserting that it "provide[d] the necessary care and services for each and every resident identified" so that there could be no potential for "even the most minimal harm." RR at 22. Lakeridge's argument has no merit, however, since the record shows that Lakeridge failed to provide care and services it determined the residents needed, and these failures had the potential for causing avoidable pressure sores, injuries from falls, and other harm to residents that is more than minimal.

We therefore affirm the ALJ's FFCL 4.

VI. The ALJ properly concluded that Lakeridge failed to substantially comply with section 483.25(c).

Section 483.25(c) provides:

Pressure sores. Based on the comprehensive assessment of a resident, the facility must ensure that-

(1) A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and
(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

In FFCL 5, the ALJ found that, in the case of four residents, Lakeridge had failed to ensure that residents who entered the facility without pressure sores did not develop them unless unavoidable and/or that residents with pressure sores received necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. The ALJ also found that Lakeridge's noncompliance presents the potential for more than minimal harm, since "[p]ressure sores can lead to infection and certainly cause discomfort and pain to the residents with such sores." ALJ Decision at 31-35.

The facts found by the ALJ regarding Residents 24 and 29 are similar in that they both involve the lack of pressure-relieving devices on a chair as well as surveyors' observations of treatment of a pressure sore. The ALJ found that Resident 24 was at risk for pressure sores and had a pressure sore on her coccyx that increased in size from August 17 to August 26, 1999. ALJ Decision at 31. The ALJ further found that this resident had no pressure-relieving devices on her bed or chair at any time during the survey. Id. The ALJ found in addition that Lakeridge had not specifically disputed evidence in the SOD and surveyor notes that, although the resident had a physician's order for a dressing to be applied to her pressure sore, there was no dressing on the pressure sore at the time of treatment for that pressure sore on August 26. ^{(19) (20)} Id. at 32, citing CMS Ex. 3, at 56, and CMS Ex. 24, at 14. The ALJ concluded that "the absence of a dressing on Resident 24's sore alone supports my finding that Petitioner did not do all it could to promote healing of Resident 24's pressure sore." ALJ Decision at 32.

The ALJ found that Resident 29 was at risk for pressure sores and had a pressure sore on her coccyx that increased in size from August 17 to August 26. ALJ Decision at 32. The ALJ also found that there was a physician's order for an eggcrate pad on the resident's chair, but that, throughout the survey, the resident was restrained in a wheelchair with no pressure-relieving devices. Id. at 32-33. The ALJ further found that, during pressure sore treatment on August 21, there was dried feces on the resident's buttocks beneath the sore's loose dressing and that the nurse did not remove her gloves, which became soiled with feces, before irrigating and wiping the open pressure sore with saline. Id. at 33, citing Tr. at 126, and CMS Ex. 3, at 58. The ALJ concluded that "[b]y not providing the interventions as stated in the physician's orders and not cleaning her pressure sore as required, Petitioner was not doing what it could to prevent infection or promote healing of Resident 29's pressure sore." Id. at 33. ⁽²¹⁾

Lakeridge argues that "[t]he physician's order regarding the resident's use of the chair did not include an order for pressure relief devices." RR at 23. It is unclear whether Lakeridge is referring to Resident 24 or to Resident 29 since Lakeridge does not refer to either resident by number (or any other identifier such as initials). Lakeridge's argument refers to some findings that appear in the ALJ Decision only with respect to Resident 24, but Lakeridge cites Petitioner Exhibit 32, which relates to Resident 29. Compare with resident identifier at CMS Ex. 7. Our review of Lakeridge's exhibits does not reveal any that relate to Resident 24.

Clearly, however, there is nothing in Lakeridge's request for review that addresses the evidence cited by the ALJ that Lakeridge failed to follow the physician's orders for a dressing for Resident 24. We agree with the ALJ that this undisputed evidence is sufficient to support a deficiency finding with respect to Resident 24. Even if the ALJ had relied on the lack of a pressure-relieving device on this resident's chair, moreover, nothing in the record contradicts the ALJ's finding.

Petitioner Exhibit 32 does show that, contrary to what Lakeridge argues, there was a physician's order for a pressure-relieving device on Resident 29's chair. P. Ex. 32, at 14 (order signed by physician on 8/2/99 for "EGGCRATE PAD to chair while up"). However, the same exhibit also contains a treatment record for Resident 29 with initials showing that there was an eggcrate pad on the chair on each day of the survey for three nursing shifts, with the exception of one nursing shift on August 27. P. Ex. 32, at 48. The ALJ Decision does not refer to this evidence, so it is unclear why the ALJ did not credit it.

However, there is nothing in Lakeridge's request for review that addresses the evidence cited by the ALJ that Resident 29's pressure sore was not cleaned as required. We conclude that this undisputed evidence is sufficient to support a deficiency finding with respect to this resident. Moreover, there is undisputed evidence (not cited by the ALJ) that on August 21, 1999, Lakeridge left Resident 29 in her wheelchair for over four hours without repositioning, although there was a physician's order to reposition Resident 29 every two hours. CMS Ex. 3, at 57; Tr. at 127.

With respect to Resident 9, the ALJ found that, by August 21, 1999, the resident had developed a pressure sore on his left lower buttocks and in addition had numerous other pressure sores. ALJ Decision at 33-34. The ALJ further found that, on August 21, the resident was restrained in a wheelchair without a pressure-relieving device and without repositioning for around three hours, and that he had a urine-soaked brief when the nurse aide placed him in his bed, which did not have pressure-relieving device. Id. at 34. The ALJ concluded that "[b]oth sitting for long stretches and sitting in urine promote pressure sores and prevent healing of pressure sores." Id., citing Tr. at 264, 66, 271, 588.

Lakeridge argues that the ALJ "concedes" that the resident had an abrasion, rather than a pressure sore and that it "cannot be held that there was a deficiency at this tag when there was the presence of an abrasion, not a pressure sore." RR at 24. This argument ignores the ALJ's separate findings, based on the evidence presented by CMS, that Resident 9 had developed numerous pressure sores. Surveyor Poole testified that the so-called "abrasion" on the resident's left buttock was only one of these pressure sores. Tr. at 260. Thus, there is substantial evidence in the record to support the ALJ's finding of noncompliance as to Resident 9. ⁽²²⁾

With respect to Resident 8, the ALJ found that the resident had a Stage II pressure sore on her coccyx, and that the resident was seated with a restraint on August 21, 1999 for over six hours in a chair without a pressure-relieving device, contrary to the requirement in the resident's care plan that she be released from her restraint every two hours and walked to help her pressure sore. ALJ Decision at 34. The ALJ concluded that "[s]itting for long periods without a pressure relieving device promotes new pressure sores and impedes healing of existing pressure sores," in violation of section 483.25(c). Id. at 35, citing Tr. at 271.

Lakeridge argues only that "the facility was cited for allegedly failing to have pressure relieving devices for the bed despite the fact that the resident's attending physician entered an order for an egg crate mattress 'to prevent further skin breakdown.'" RR at 24. While it is correct that CMS based its finding of noncompliance in part on this alleged failure, the ALJ did not rely on it. See ALJ Decision at 35 (stating that "even assuming that Resident 8 did have a pressure relieving mattress, petitioner did not respond to the surveyor's observation that Resident 8 was left sitting in a chair for over six hours without a pressure relieving device on the chair"). Accordingly, Lakeridge's argument does not provide a basis for reversing the ALJ's finding of noncompliance as to this resident. ⁽²³⁾

Lakeridge also disputes the ALJ's finding that its noncompliance with section 483.25(c) presents the potential for more than minimal harm, asserting that it "provide[d] the necessary care and services for each and every resident identified" so that there could be no potential for "even the most minimal harm." RR at 24. Lakeridge's argument has no merit, however, since the record shows that Lakeridge failed to provide care and services it determined the residents needed and since these failures had the potential for causing avoidable pressure sores or for causing existing pressure sores to become infected.

We therefore affirm the ALJ's FFCL 5.

VII. The ALJ properly concluded that Lakeridge failed to substantially comply with section 483.25(d)(2).

Section 483.25(d)(2) provides:

Urinary Incontinence. Based on the resident's comprehensive assessment, the facility must ensure that -

* * * * * * *

(2) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

In FFCL 6, the ALJ found that Lakeridge failed to provide the care and services required by section 483.25(d)(2) in the case of six residents.

As to Resident 39, the ALJ found that this resident required extensive physical assistance with toileting and that, as part of a restorative toileting training program, Resident 39's plan of care required toileting in advance of need. The ALJ relied on Surveyor Truett's testimony, which was supported by surveyor notes, that, on August 21, 1999, she observed that the resident was not offered toileting for an extended period of time. ALJ Decision at 36, citing Tr. at 128, and CMS Ex. 17, at 5. The ALJ also relied on surveyor notes indicating that on August 26, Resident 39 was left in her wheelchair for three hours without an offer of toileting. Id., citing CMS Ex. 17, at 36. The ALJ noted that LPN Griffin testified that Resident 39 refused to get up and use the toilet because the process was painful for her and preferred to use the bedpan instead. Id., citing Tr. at 689. (The testimony cited by the ALJ in fact refers to Resident 31, not Resident 39. Tr. at 688.) The ALJ concluded that "[e]ven if Resident 39 preferred to use the bedpan instead of being taken to the toilet, she could have been offered the use of the bedpan in advance of need so that she could maintain continence." ALJ Decision at 36.

Lakeridge argues that the ALJ "finds a deficiency under this tag because the facility did not violate the resident's right to refuse treatment." RR at 25. However, the ALJ's conclusion is not inconsistent with the resident's right to refuse treatment (assuming that this resident had in fact refused to get up and use the toilet). ⁽²⁴⁾

As to Resident 31, the ALJ found that this resident was dependent on the staff for toileting and was assessed as frequently incontinent of bladder. ALJ Decision at 36. The ALJ stated that Lakeridge had not responded to CMS's allegation, based on surveyor testimony and surveyor notes, that on August 24, 1999, a nurse aide who changed the resident's brief did not offer to take her to the toilet (in spite of her expression that she was ashamed when she had to urinate on herself) and that, on August 25, the nurse aide who changed the resident's brief (after she had had no toilet care for almost three hours) also did not offer to take her to the toilet. Id., citing Tr. at 133-135, and CMS Ex. 18, at 14, 16.

Lakeridge asserts that the ALJ ignored the records it submitted that "demonstrate that the facility planned for and successfully implemented intervention to treat incontinence and to prevent infection." RR at 25, citing P. Ex. 29. However, Lakeridge does not claim on appeal that it did respond to the surveyor's allegation regarding its failure to offer toileting to Resident 31. Moreover, Lakeridge does not cite specific evidence in Petitioner Exhibit 29 to support its position, nor do we find any. Exhibit 29 does show that the resident's plan of care for continence provided the following: "Check attends [every two hours]" and "Staff to anticipate and meet needs promptly." P. Ex. 29, at 36. The unrebutted testimony indicates, at the least, that Lakeridge was not fully implementing these interventions, and constitutes substantial evidence in support of the ALJ's findings.

As to Resident 29, the ALJ based her findings for this resident on Surveyor Truett's observation that, on August 21, 1999, a nurse aide providing incontinence care to this resident (who had a urinary tract infection and a history of e coli urinary tract infections) had caused feces to be spread over the nurse aide's gloves, the resident's catheter tubing, and under the dressing on her buttocks. ALJ Decision at 37. The ALJ stated that Lakeridge's argument that the resident's care plan required wiping the catheter tubing "does not change the fact that feces should not come into contact with a catheter tube." Id., citing Tr. at 138-139 (surveyor testimony that "leaving the tubing contaminated with feces increases contamination of the urinary tract with feces").

Lakeridge contends that the basis for the ALJ's finding regarding this resident is that "the method in which catheter care was administered was inconsistent with the surveyor's preference." RR at 25. ⁽²⁵⁾ According to Lakeridge, the ALJ ignored evidence in Petitioner Exhibit 32 showing that "the nursing assistant properly cleaned the resident's catheter after incontinence care was provided." Id. (emphasis added). In fact, while Petitioner Exhibit 32 shows that catheter care was provided on the date in question, there is nothing in that exhibit or in the nurse's notes that specifically states that the catheter was cleaned or at what point. See P. Ex. 47, at 40, 47. In any event, Lakeridge points to no evidence rebutting the surveyor's testimony as to what occurred during incontinence care or indicating that it is appropriate during incontinence care to spread feces on catheter tubes, nor does Lakeridge assert that this would not present a risk of urinary tract infection.

Lakeridge also appears to argue that the ALJ's finding of noncompliance as to Resident 29 was unwarranted because CMS failed to establish that the resident developed a urinary tract infection after the incident in question. RR at 25. As discussed above with respect to FFCL 1, however, no finding of actual harm is necessary.

As to Resident 26, the ALJ found that this resident was assessed as incontinent of bowel and bladder and that her June 1999 plan of care called for her to be taken to the bathroom after meals and at her request. The ALJ also relied on the surveyor's observations that, throughout the survey, Resident 26 was not offered toileting after meals or at bedtime. ALJ Decision at 37, citing P. Ex. 3, at 66-68 and CMS Ex. 25, at 3-6.

Lakeridge argues that the ALJ "refuses to recognize . . . that the surveyor cannot possibly observe the resident continuously after meals to determine whether or not toileting was offered." RR at 26. The surveyor notes on which the ALJ relied, however, record that, on August 26, 1999, the surveyor observed the resident being brought back to her bedroom from the dining room after breakfast and then being "left" in her wheelchair with a lap buddy and "[no] toilet." CMS Ex. 25, at 6. (An almost identical observation was made the previous day, except that the notation "[no] toilet" does not immediately follow the observation that the resident was left in her wheelchair with a lap buddy. Id. at 5.) In any event, even if the surveyor was not continuously observing the resident during the period after breakfast, her observations (recorded about every 10 or 15 minutes) were sufficient to shift the burden to Lakeridge to show that it regularly offered toileting to the resident after meals according to the plan of care. Yet, Lakeridge cites to no evidence to that effect.

Lakeridge also asserts that Resident 26 was able to advise when she needed to go to the bathroom and was able to use a call light and to follow simple directions and instructions. According to Lakeridge, these facts, combined with the fact that a bowel and bladder program was in place for this resident, indicate that "she was receiving appropriate incontinence treatment and had the need arisen, she was capable of requesting it if toileting was not immediately offered." RR at 26. As the ALJ Decision indicates, however, any ability the resident had to advise when she needed to go to the toilet is irrelevant since "an offer of toileting after meals was part of her care plan." ALJ Decision at 38. Moreover, Lakeridge's reliance on the resident having a bowel and bladder program is misplaced since Lakeridge waited almost two months after assessing Resident 26 as incontinent of bowel and bladder before instituting the bowel and bladder program on August 25 (during the survey). See ALJ Decision at 37, citing CMS Ex. 3, at 66-67; see also P. Ex. 33, at 27 (8/5/99 monthly summary indicating no bowel or bladder training program).

As to Resident 30, the ALJ found that on August 24, 1999, the resident was found lying on her back for over an hour wearing a soiled incontinence brief and that, when the nurse aide changed the brief, she did not clean the resident's perineal area before applying a clean brief. ALJ Decision at 38, citing Tr. at 145-146 and CMS Ex. 3, at 68. ⁽²⁶⁾ The ALJ stated that she agreed with LPN Griffin that a restorative program was not appropriate for this resident (since at the time of the survey the resident was at the end stage of her life and on comfort measures only). However, the ALJ stated that "no resident should be left lying in urine" and that the resident should have been cleaned before application of a new brief. ALJ Decision at 38.

Lakeridge asserts that "[a] successful bowel and bladder plan had been implemented until the resident was no longer able to comprehend it" and that the facility thereafter used "only comfort measures." RR at 26. Since Lakeridge does not explain how failing to timely change the resident's brief and then failing to properly clean her would promote the resident's comfort, however, the ALJ's finding as to this resident is not inconsistent with any physician's order for comfort measures only.

As to Resident 9, the ALJ finding was based on Surveyor Poole's testimony that, on August 21, 1999, after removing a soiled brief from the resident, a nurse aide reapplied the urine-soaked brief on the resident. The ALJ found that, since Resident 9 already had skin breakdown, reapplying a urine-soaked brief would create more skin breakdown because of the caustic effect of urine. ALJ Decision at 39, citing Tr. at 275.

Lakeridge argues, as it did before the ALJ, that Resident 9 was a hospice patient in the end stages of his life, that his family did not want the resident's briefs changed because it caused stress on his heart, and that Lakeridge was honoring this request. RR at 27, citing Tr. at 693 (testimony of LPN Griffin). However, the cited testimony does not refer to the wishes of the resident's family. Instead, LPN Griffin stated that the resident's cardiologist "was not too big about us . . . running him around the room and going to the bathroom." Even this testimony does not indicate that changing the resident's brief was medically contraindicated, however. Moreover, Lakeridge does not dispute the ALJ's finding regarding the risk of reapplying a urine-soaked brief that had already been removed.

Lakeridge also disputes the ALJ's finding that its noncompliance with section 483.25(d)(2) presents the potential for more than minimal harm, asserting that it "provide[d] the necessary care and services for each and every resident identified" so that there could be no potential for "even the most minimal harm." RR at 27. Lakeridge's argument has no merit, however, since the record shows that Lakeridge failed to provide care and services it determined the residents needed and since these failures had the potential for causing harm such as urinary tract infections that is more than minimal.

We therefore affirm the ALJ's FFCL 6.

VIII. The amounts of the immediate jeopardy and the non-immediate jeopardy CMPs were reasonable.

In FFCL 7, the ALJ found that both the immediate jeopardy and non-immediate jeopardy CMPs assessed by CMS were reasonable in amount based on the factors under 42 C.F.R. � 488.438(f). These factors are: the facility's history of noncompliance (including repeated deficiencies), the facility's financial condition, the factors listed in 42 C.F.R. � 488.404, and the facility's degree of culpability. The factors listed in section 488.404 include the scope and severity of the deficiencies, and the relationship of one deficiency to other deficiencies resulting in noncompliance. The regulations define culpability as neglect, indifference, or disregard for resident care, comfort or safety. 42 C.F.R. � 488.438(f)(4).

In evaluating the reasonableness of the CMPs, the ALJ noted that the $5,150 per day CMP assessed for the period of immediate jeopardy, which was based primarily on Lakeridge's failure to comply with section 483.25(h)(2) (restraints), is in the middle of the immediate jeopardy range. The ALJ found that "serious danger was likely given the inappropriate application of the restraints" and that at least six residents were affected. ALJ Decision at 40. The ALJ further noted that "Petitioner has had a relatively poor compliance history," having been cited in a prior survey for failure to ensure adequate supervision and assistance devices. Id., citing CMS Ex. 93. In addition, the ALJ stated that Lakeridge's staff "appeared indifferent about the plight of the residents who were restrained. They walked by the doors of residents, such as Resident 74, without coming to the resident's aid." Id. at 41. ⁽²⁷⁾ With respect to the $1,150 per day CMP assessed for the non-immediate jeopardy deficiencies, the ALJ noted that this was in the middle of the range for such CMPs, that the scope of the deficiencies is "wide, as each deficiency affected a number of residents," that the "seriousness of the deficiencies was fairly high because of the actual harm that residents incurred as a result of the noncompliance," and that Lakeridge had "prior deficiencies related to prevention of accidents and care of pressure sores." Id. The ALJ also stated that, although she found for Lakeridge on one of the alleged deficiencies (in FFCL 3), there were "a sufficient number of deficiencies at a scope and severity to support the [non-immediate jeopardy] CMP." Id.

Lakeridge argues that the CMPs were not warranted by "its history of noncompliance, including the presence, if any, of repeat deficiencies . . . , the seriousness of any proven prior deficiencies, [or] the relationship between those deficiencies . . . ." RR at 27. Lakeridge contends that, "[s]hould substantial non-compliance be established, . . . a CMP of no more than $50/day is warranted." Id. at 28.

It is not clear whether Lakeridge intends to dispute the ALJ's findings regarding its history of noncompliance. Contrary to what Lakeridge asserts, however, the ALJ did not find that there were any repeated deficiencies. Moreover, as the ALJ Decision indicates, CMS Exhibit 93 shows that a survey on January 20, 1999 found a Level G deficiency under section 483.25(h)(2) (Tag F-324 - accidents) and a Level G deficiency under section 483.25(c) (Tag F-314 - pressure sores). CMS Ex. 93, at 1. Thus, the ALJ properly relied on Lakeridge's history of noncompliance as a factor in determining the reasonableness of the amounts of both CMPs.

Furthermore, contrary to what Lakeridge asserts, the ALJ did not rely on the seriousness of the prior deficiencies or the relationship between those deficiencies as a factor in determining that either CMP amount was reasonable. The ALJ did, however, rely on the seriousness of the deficiencies found in the August 1999 survey. CMS assessed the deficiency under section 483.25(h)(2) (Tag F-324) as Level K (a pattern of immediate jeopardy to resident health or safety). See CMS Ex. 3, at 80; SOM, App. P, sec. V. For the reasons discussed above, we upheld the ALJ's conclusion that CMS's determination of immediate jeopardy was not clearly erroneous. We also upheld this deficiency finding as to all six residents cited in the SOD. Thus, the ALJ properly relied on CMS's assessment of the seriousness of the deficiency under section 483.25(h)(2) in determining the reasonableness of the $5,150 per day CMP.

CMS assessed the deficiencies under sections 483.13(a) (Tag F-221), 483.25 (Tag F-309), 483.25(c) (Tag F-314) and 483.25(d)(2) (Tag F-316) as Level H (a pattern of actual harm with a potential for more than minimal harm that is not immediate jeopardy). See CMS Ex. 3, at 5, 36, 54 and 62; SOM, App. P, sec. V. We upheld each of these deficiency findings as to all of the residents cited in the SOD (except that we did not fully resolve the issues regarding three of the seven residents cited under section 483.13(a)). ⁽²⁸⁾ Thus, the ALJ properly relied on CMS's assessment of the scope and severity of the deficiencies in determining the reasonableness of the $1,150 per day CMP. ⁽²⁹⁾

Moreover, Lakeridge does not dispute the factual basis for the ALJ's finding that its staff appeared indifferent about the plight of the residents who were restrained. Thus, the ALJ properly relied on this finding, which meets the definition of "culpability" in section 488.438(f)(4), in determining the reasonableness of the $1,150 per day CMP.

Finally, Lakeridge does not offer any reason why the ALJ erred in determining that the combination of the factors that the ALJ found were present supports the CMPs in the amounts assessed by CMS.

We therefore affirm the ALJ's FFCL 7. ⁽³⁰⁾

IX. The ALJ's evidentiary and procedural rulings were proper.

In FFCL 8.c., the ALJ declined to change any of the evidentiary and procedural rulings she made to which Lakeridge had objected. ALJ Decision at 42. Lakeridge takes exception to these rulings, citing the objections it raised at the hearing. We discuss Lakeridge's major objections below, to the extent not already addressed in this decision.

Lakeridge excepts to the ALJ's "[p]ermitting CMS to examine witnesses using two attorneys to 'tag-team' the witnesses," identifying several instances in which the same witness was examined by one of CMS's two attorneys regarding certain tags and by CMS's other attorney regarding other tags. RR at 29. At the hearing, Lakeridge objected to this procedure as "inappropriate," noting that it had been specifically prohibited by another ALJ in another proceeding and that the rules of the United States District Courts prohibit it. The ALJ stated that she would permit CMS to examine witnesses in this manner unless it became "cumbersome" or otherwise affected the procedure. Tr. at 95-97. On the second day of the hearing, Lakeridge's counsel declined to respond to the ALJ's inquiry as to "what prejudice" to Lakeridge there had been "so far." Tr. at 574. Since Lakeridge failed to identify any prejudice to it, we find no error in the ALJ's ruling.

Lakeridge also excepts to the ALJ's admitting certain testimony by the four surveyors. Lakeridge identifies numerous instances where it claims that the ALJ erroneously permitted the surveyors to "to diagnose resident symptoms and conditions, and testify outside the scope of their licenses and beyond their capacity." RR at 29. Most of this testimony went to whether various residents had a diagnosis that justified the use of a restraint (Tr. at 30, 54, 57, 225, 459, 460, 564, 568, 636) and whether the facility failed to provide adequate supervision and assistance devices to prevent accidents (Tr. at 45, 70, 78, 99, 548, 550). Lakeridge also identifies numerous instances where it claims that the ALJ erred in "[p]ermitting surveyors to speculate on risk of harm for which they lack capacity and determines the ultimate legal conclusion." Id. at 30 (sic). Most of this testimony went to the likelihood of harm from application of a restraint (Tr. at 39, 64, 70, 72, 226, 233, 452, 477, 552).

We find no basis for Lakeridge's claim of error in the ALJ's admitting this testimony. Contrary to what Lakeridge argues, the surveyors were not purporting to make diagnoses or to state legal conclusions, but rather to give their opinion on whether, in light of the diagnoses in the residents' medical records, restraints were justified or supervision and assistance devices provided were adequate, and on the risk of harm if they were not. Moreover, Lakeridge does not argue that the surveyors' opinions on the risk of harm, which necessarily involved some degree of speculation, had no factual basis.

Lakeridge also alleges that the surveyors were not knowledgeable about "current clinical practice standards," primarily because they had no recent clinical experience. RR at 30, citing Tr. at 148-149, 215, 278, 435, 437, 481, 524, 550, and 552. The Board has held, however, that "[t]he evidentiary test for opinion testimony by experts . . . is whether the witness is 'qualified as an expert by knowledge, skill, experience, training, or education . . . .'" See, e.g., Omni Manor Care Center, DAB No. 1920 (2004) at 10, n.12 (citing Rule 702 of the Federal Rules of Evidence). All of the surveyors who testified here were licensed professionals (three registered nurses and one registered dietician) and each had passed the surveyor minimum qualifications test, received annual training, and participated in 500 or more surveys. Tr. at 15-18, 216-217, 435-437, 524-526. Thus, it was within the ALJ's purview to determine that the surveyors had knowledge of the areas as to which they testified by virtue of their education, training, and experience.

Lakeridge also takes exception to several unrelated evidentiary rulings, which we address below.

Lakeridge excepts to the testimony of Surveyor Stahl that Surveyor Slusher observed a nurse untying Resident 73's restraint at 10:32 a.m. (following Surveyor Stahl's observation of Resident 73 trying to untie the restraint beginning at 10:05 a.m.) as "compound hearsay." RR at 30, citing Tr. 475. Similarly, Lakeridge excepts on the same basis to the ALJ admitting testimony that CMS Exhibit 21 contained a doctor's order for a dressing a scabbed skin sore on Resident 74's toe. Id., citing Tr. at 577. Since the ALJ was not bound by the Federal Rules of Evidence, we conclude that the ALJ did not err in admitting this testimony. ⁽³¹⁾

Lakeridge excepts to Surveyor Slusher's testimony that skin breakdown is not required for a citation under Tag F-309 (the general quality of care provision in section 483.25). RR at 30, citing Tr. at 640. At the hearing, Lakeridge objected to CMS counsel's question eliciting this testimony on the ground that the question called for a legal conclusion. The ALJ did not expressly address this objection, but proceeded to ask the witness a similar question. The testimony addressed the application of the regulation to particular facts, a matter as to which the surveyor was qualified to testify. Moreover, it is the ALJ's prerogative to question witnesses to clarify matters. We therefore see no error in the admission of this testimony.

Lakeridge excepts to the ALJ's permitting "speculative, irrelevant testimony by surveyors on what physicians do within the scope of a physician's practice," citing testimony that doctors rely heavily on nursing recommendations in issuing orders for restraints. RR at 30, citing Tr. at 56. The ALJ noted at the hearing that this testimony pertained only to the surveyor's experience. We see no reason why the surveyor was not competent to testify on this matter based on her experience. Moreover, this testimony is relevant to the issue raised by Lakeridge of the weight to be given to physician's orders for a restraint. We therefore see no error in its admission.

Finally, Lakeridge excepts to the ALJ's denying its motion to strike as nonresponsive Surveyor Stahl's testimony in response to the ALJ's own inquiry whether the surveyor would expect a facility to not use a restraint if there is both a note from the representative of the resident asking that a restraint be used and a physician's order for a restraint. RR at 30, citing Tr. at 465-467. We see no basis for Lakeridge's characterization of the surveyor's testimony as nonresponsive, nor find any error in its admission. (At the hearing, Lakeridge also objected to the ALJ's question on the ground that it asked for a legal conclusion. As the ALJ noted, however, the question was instead "what her expectation is as a surveyor when she goes into a facility." Tr. at 476.)

We therefore affirm the ALJ's FFCL 8.c.

Conclusion

For the reasons explained above, we affirm and adopt all of the FFCLs to which Lakeridge takes exception.

Donald F. Garrett

Cecilia Sparks Ford

Judith A. Ballard
Presiding Board Member

1. The ALJ Decision states that the survey was conducted "[o]n August 27, 1999." ALJ Decision at 1. The record indicates that, the survey began on August 21 and ended on August 27. CMS Ex. 7A, at 1-2. (All exhibits referred to in this decision as "CMS" exhibits are identified in the record as "HCFA" exhibits. CMS was previously known as HCFA (the Health Care Financing Administration).)

2. The SOD cited more than six deficiencies; however, CMS agreed at a prehearing conference to proceed only on six of them, primarily those that were assessed at a scope and severity level of "G" or above. ALJ Decision at 4. Level G denotes a deficiency that poses actual harm that is not immediate jeopardy and is isolated in scope. CMS State Operations Manual (SOM), Appendix (App.) P, sec. V.

3. Our summary of the facts regarding individual residents is intended to provide a general framework for understanding the ALJ Decision and is not a substitute for the ALJ's findings.

4. Lakeridge also makes several other general arguments. See Request for review (RR) at 6-8. To the extent that these remaining arguments involve issues that are raised by the facts of this case, we address them in the context of Lakeridge's exceptions to the FFCLs regarding individual deficiencies. We also found the same general arguments (made by the same counsel) to be without merit in Community Skilled Nursing Centre, DAB No. 1987, at 6-8 (2005).

5. The ALJ set out the following reasons for her ruling:

• The state agency is required to investigate complaints within a certain number of days regardless if the facility is under a plan of correction.
• The residents and incidents alleged for Tag F-324 from the August 27^th survey is very different from Tag F-324 as cited in the July 30^th survey.
• Although as yet unproven, the deficiencies cited in Tag F-324 from the August 27^th survey could have seriously affected residents' welfare.
• Pursuant to 42 C.F.R. � 488.330(b)(2), a certificate of noncompliance requires enforcement action and enforcement action must include termination of Medicare or Medicaid provider agreements or application of alternative remedies.
• If CMS can terminate a contract in this situation, as Petitioner concedes, CMS can apply alternative remedies as well. [footnote omitted]
• A facility may not appeal CMS's choice of remedy. 42 C.F.R. � 488.408(g)(1).
• With the particular circumstances alleged in this case, for the residents' well being, and the need for immediate correction of any deficiency posing immediate jeopardy, a correction could not wait until the end of the period of correction.
• An accepted plan of correction does not give a provider a "free zone" for noncompliance in every case.

6. The ALJ made the same finding as part of FFCL 8.c.

7. Lakeridge also makes the same exception to FFCL 8.c. RR at 29.

8. Lakeridge argues that the ALJ thus impermissibly applied a "strict liability standard" in upholding the deficiency finding under section 483.25(h)(2) and many other tags. RR at 9. As the ALJ recognized, the concept of "strict liability" is inapplicable here. ALJ Decision at 12. The issue under the regulations is not whether the facility is "liable" to any resident (or even to the federal government) in spite of the lack of actual harm, but whether the facility is substantially complying with the federal requirements for certification. The regulations define "substantial compliance" in terms of the potential for no more than minimal harm. 42 C.F.R. � 488.301.

9. The numbered heading for FFCL 2 refers only to section 483.13; however, the SOD cites section 483.13(a) (CMS Ex. 3, at 5), and it is clear that the ALJ intended to refer only to that subsection.

10. The ALJ also cited CMS Exhibit 80, the Interpretative Guidelines CMS publishes in the SOM, to support her conclusion that "a physician's prescription alone . . . does not justify the use of a restraint." ALJ Decision at 19. Lakeridge argues that the ALJ erred in "[p]ermitting the use of the SOM as evidence of a regulatory violation," citing objections it made at the hearing to CMS counsel's questions regarding SOM provisions on restraints on the ground that the SOM by its own terms provides guidance to surveyors and is not binding on facilities. RR at 30, citing Tr. at 203, 255. (This argument appears in Lakeridge's exception to FFCL 8.c.) The ALJ overruled these objections and commented in her decision that "[n]o error is created by" using the SOM "as a guideline in determining compliance with regulatory standards." ALJ Decision at 42.

We need not determine whether this ruling was proper since it is clear from the wording and context of the regulatory requirement, and its history, that the responsibility for ensuring that restraints are used in accordance with the regulatory criteria lies with the facility.

11. The resident room number on the last document is 221B, which corresponds to Resident 61 on the list of resident identifier numbers at CMS Exhibit 7. However, the resident's first initial corresponds to that of Resident 60, and other documents for Resident 60 show her room number as 221A, consistent with CMS Exhibit 7. (Lakeridge's request for review mistakenly refers to Resident 60 as a male. RR at 17.)

12. The regulations on resident assessments provide that a comprehensive assessment must be done within 14 days after the resident's admission, and reviewed quarterly thereafter, as well as in certain other circumstances where there is a "significant change" in the resident's physical or mental condition, as defined in the regulation. 42 C.F.R. � 483.20(b) and (c). The regulations provide that a registered nurse must "conduct or coordinate each assessment with the appropriate participation of health professionals," that a "registered nurse must sign and certify that the assessment is completed," and that "[e]ach individual who completes a portion of the assessment must sign and certify the accuracy of that portion of the assessment." 42 C.F.R. � 483.20(h). In contrast, the regulations regarding the comprehensive care plans (that must be developed to meet the resident's needs as identified in the comprehensive assessment) provide that the plan must be prepared "by an interdisciplinary team." 42 C.F.R. � 483.20(k)(2)(ii).

13. Lakeridge cites "P. Ex. 45" in support of its allegation that Resident 62's "diagnoses are consistent with the use of restraints." RR at 17. However, Lakeridge did not move to have that exhibit admitted into the record. See Tr. at 9. While LPN Griffin testified with respect to Resident 62 that less restrictive alternatives were tried first, she did not indicate that any formal assessment was done for this resident. Tr. at 666-667.

14. The ALJ cited to the testimony of Surveyor Truett that no restraint reduction program was ever implemented for Resident 29. LPN Griffin testified that Lakeridge had begun a restraint reduction program for this resident before the survey, but she did not identify any exhibit which showed that (nor did Lakeridge do so in its post-hearing brief, as its counsel indicated it would). Tr. at 709-710. The ALJ did not specifically state that she did not find LPN Griffin's testimony credible; however, it is clear that the ALJ gave greater weight to Surveyor Truett's testimony. Absent clear error, the Board defers to the findings of the ALJ on weight and credibility of testimony. See, e.g., Batavia Nursing and Convalescent Center at 27, citing Koester Pavilion at 15. It was not clear error for the ALJ to rely on Surveyor Truett's testimony, especially in the absence of any facility records supporting LPN Griffin's allegation.

15. Similarly, a restraint assessment for Resident 60 indicated that imposition of a waist restraint while she was in bed was required on a temporary basis because she had sutures in her forehead as a result of a fall. P. Ex. 44, at 53. The record shows that the sutures were removed on August 20, yet Lakeridge did not discontinue use of the restraint until August 26, when it obtained a physician's order to do so. Id. at 5, 47, 52.

16. In Spring Meadows Health Care Center, the Board noted that a facility is not precluded from showing that its policy set a higher standard than the professional standards of quality, in which case the facility's failure to comply with the policy alone would not be a basis for a deficiency finding under section 483.25. At 18, n.9. Lakeridge does not argue that this was the situation here.

17. The ALJ Decision indicates that Lakeridge failed to comply with a facility policy to turn residents every two hours when it left Resident 49 seated in a geri-chair for almost six hours without a position change. ALJ Decision at 29, citing P. Ex. 35, at 27. The ALJ appears to have misread the facility's policy to require repositioning residents every two hours while they are up in a chair, as well as when confined in bed. This misreading is irrelevant to the ALJ's conclusions, however, since Resident 49's care plan includes a directive, in effect during the time in question, to re-position every two hours that is not limited to when the resident is in bed. P. Ex. 35, at 42. Moreover, the ALJ further found that the facility violated its own policy by not using a cushion on the resident's chair. ALJ Decision at 29. Lakeridge's "Procedure for Skin at Risk" said to "[a]void pressure on boney prominences by using pillows or foam to position the resident." P. Ex. 35, at 27.

18. Lakeridge cites its Exhibit 35 as support for its contention that Resident 74 received appropriate care and services, but this exhibit refers to Resident 49. Compare with resident identifier at CMS Ex. 7.

19. The ALJ Decision cites CMS Exhibit 24, at 14, as evidence of the physician's order. ALJ Decision at 32. This exhibit is a pressure ulcer report from April 20, 1999, signed by a physician, that says to "cleanse open area on coccyx" with "NS, apply PSO and DD Bid T/H." CMS Ex. 24, at 14. In this context, "DD" appears to refer to a dry dressing. Dorland's Medical Abbreviations at 84 (1992).

20. The ALJ Decision indicates that there was conflicting evidence regarding whether Resident 24 had a pressure sore at the time of the survey, stating that Lakeridge "submitted the July and August monthly summaries for Resident 24 that note no skin breakdowns for her." ALJ Decision at 32, citing P. Ex. 37, at 15-17. However, this exhibit relates to Resident 17. Compare with resident identifier at CMS Ex. 7.

21. Surveyor Truett testified that the danger to the resident from feces coming into contact with a pressure sore was that it can contribute to the development of infections, which would prevent healing and probably make the wound become larger. Tr. at 125. She also testified that, in using gloves that had feces on them when she wiped the wound, the nurse recontaminated the wound that she was trying to clean. Tr. at 126. In Barbourville Nursing Home, DAB No. 1962 (2005), the Board concluded, based on similar facts, that the ALJ did not err in upholding CMS's determination of immediate jeopardy.

22. Lakeridge also argues that the ALJ "concedes" that the resident refused to wear heel protectors, which the physician had ordered when the resident was in bed. RR at 24. The ALJ Decision does not appear to rely on the surveyor's observation that Resident 9 was in bed without heel protectors, however. See ALJ Decision at 34.

23. The SOD states that Resident 8's current plan of care "was silent as to any pressure relieving device for the chair . . . ." CMS Ex. 3, at 61. (An undated care plan for the resident (which was updated November 10, 1999) states "EGGCRATE PAD TO CHAIR WHEN UP FOR COMFORT AND PRESSURE RELIEF." P. Ex. 24, at 1.) However, the resident's plan of care dated May 17 (in effect until August 26) included as part of the approach to address pressure ulcers "Release her from waist restraint every two hours and walk." P. Ex. 24, at 4. Thus, in keeping the resident in her chair for six hours, Lakeridge failed to follow the plan of care, regardless of whether it was required to have a pressure-relieving device on the chair.

24. The ALJ also appeared to credit the surveyor's testimony that the bowel and bladder program that Lakeridge had attempted to implement for the resident would not maintain continence because it was planned for only three to five times a week. ALJ Decision at 36. It is immaterial if Lakeridge disputes this testimony, however, since Lakeridge does not allege that it was following the bowel and bladder program for the resident the week of the survey.

25. This resident is erroneously identified in the request for review as Resident 239.

26. The surveyor testimony cited by the ALJ refers to Surveyor Truett's observation on a different day (August 22) that Resident 30 was left lying on her back from 7:30 to 8:21 a.m., which did not include an observation that the resident was incontinent at that time. Tr. at 145, referring to CMS Ex. 8, at 7. However, Surveyor Truett confirmed that the resident was not cleaned properly on August 24. Tr. at 146, referring to CMS Ex. 3, at 68. Moreover, the latter document indicates that on August 24, the resident was observed lying in bed with a soiled incontinence brief on for over two hours.

27. The example given by the ALJ may refer to the incident mentioned earlier in the ALJ Decision where a surveyor observed Resident 74 in bed tossing and turning with a vest restraint on to such an extent that he pushed his sheets and pillowcase cover off of his bed and pushed the siderail pads through the siderails, yet staff members walked by his room without coming to his assistance. ALJ Decision at 9. Another such incident involving Resident 74 was described by Surveyor Truett at the hearing. Tr. at 90.

28. The ALJ stated that the scope of the non-immediate jeopardy deficiencies is "wide, as each deficiency affected a number of residents." Since the ALJ did not use the term "widespread" (one of the three scope levels in section 488.404(b)(2) of the regulations), we read this statement as consistent with CMS's assessment of the scope of each of these deficiencies as "pattern."

29. Lakeridge was precluded from challenging the "level of noncompliance" assigned by CMS to the non-immediate jeopardy deficiencies since it would not affect the range of the CMP. 42 C.F.R. � 498.3(b)(14).

30. In taking exception to FFCL 7, Lakeridge also states that it "denies the propriety of . . . the duration that the CMP was imposed and/or the duration of the period of substantial non-compliance alleged as pertains to any and all citations . . . ." RR at 27. Lakeridge did not raise these issues before the ALJ, nor does it explain in its request for review what the bases for its position are. Accordingly, we do not consider these issues here.

31. The Board has recognized that "hearsay is admissible and may be accorded appropriate weight, if supported by adequate indicia of reliability . . . ." Pacific Regency Arvin, DAB No. 1823, at 15, n.6 (2002); see also Omni Manor Nursing Home at 16-18. In any event, although Lakeridge raised a procedural objection to Surveyor Stahl's testimony, it never disputed the finding in the SOD (which is consistent with her testimony) that "[t]he resident was left alone [from 10:05] until 10:32 AM at which time a staff nurse entered the room to assist this resident to the bathroom." See CMS Ex. 3, at 95-96.