SUBJECT: Lineville Nursing Facility,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

On October 30 and November 1, 2002 respectively, Lineville Nursing Facility (Lineville) and the Centers for Medicare & Medicaid Services ⁽¹⁾ (CMS) filed requests for review appealing an August 30, 2002 decision by Administrative Law Judge (ALJ) Anne Blair. Lineville Nursing Facility, DAB CR947 (2002) (ALJ Decision). The August 30, 2002 decision (ALJ Decision) upheld CMS's imposition of remedies for noncompliance (discovered during a November 1999 revisit survey) with the Medicare participation requirements in 42 C.F.R. �� 483.15(f)(1) and 483.25(c). In its request for review, Lineville challenges the ALJ's findings that it was not in substantial compliance with sections 483.15(f)(1) and 483.25(c) during the November 1999 revisit survey. For its part, CMS challenges a finding by the ALJ that it failed to prove Lineville's noncompliance with section 483.75(l)(1).

For the reasons below, we affirm the ALJ's findings concerning Lineville's noncompliance with sections 483.15(f)(1) and 483.25(c). In addition, we reverse the ALJ's finding under section 483.75(l)(1) and find that Lineville was not in substantial compliance with that regulation during the November 1999 revisit survey. Accordingly, we sustain the remedies imposed in this case: (1) a denial of payment for new admissions effective December 24, 1999 to February 22, 2000; and (2) civil money penalties totaling $13,500.

Background

A. Regulatory Background

Lineville is a skilled nursing facility that participates in the Medicare program. A facility's compliance with the Medicare participation requirements in 42 C.F.R. Part 483 is verified through the survey and certification process described in 42 C.F.R. Part 488, Subpart E. Surveys are usually conducted by a state agency under an agreement with CMS. A survey's findings are presented in a Statement of Deficiencies, which identifies each alleged failure to meet a participation requirement. See CMS State Operations Manual (SOM) Appendix P, ch. IV. Deficiency findings are identified in the Statement of Deficiencies using data "tags" that correspond to the participation requirements in 42 C.F.R. Part 483. Id.

If a survey reveals that a facility is not in "substantial compliance" with federal participation requirements, the facility must submit a plan of correction (POC) for approval by the survey agency. 42 C.F.R. �� 488.402(d), 488.408(f). Even if the POC is approved, the facility may not be regarded as in substantial compliance until the survey agency determines, following an onsite revisit or other means of verification, that the deficiency no longer exists. 42 C.F.R. � 488.440(h); SOM � 7316. "Substantial compliance" is defined in the regulations as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

For deficiencies that do not constitute immediate jeopardy, but either cause actual harm or create the potential for more than minimal harm, CMS may impose a CMP in the range of $50-$3,000 per day. 42 C.F.R. � 488.438(a)(2) (1998). A CMP continues to accrue until either "(1) The facility has achieved substantial compliance, as determined by HCFA or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit" or "(2) HCFA or the State terminates the provider agreement." 42 C.F.R. � 488.454(a).

B. The surveys

The Alabama Department of Public Health (ADPH) performed an annual survey at Lineville from September 14 to September 16, 1999. Based on this survey (which we refer to as the September survey), ADPH cited Lineville for nine deficiencies. CMS Ex. 21. On October 13, 1999, Lineville submitted a POC alleging that it had corrected the cited deficiencies and was in substantial compliance with Medicare participation requirements. Id.

On November 2-5, 1999, ADPH conducted a revisit survey (the "November revisit survey") at Lineville. See CMS Ex. 9. As a result of the November revisit survey, Lineville was cited for six deficiencies (including the three at issue in this appeal). None of the cited deficiencies was deemed by ADPH to place residents in "immediate jeopardy."

In a November 29, 1999 letter, ADPH notified Lineville that it would recommend to CMS that certain remedies be imposed, including civil money penalties (CMPs), if the facility did not furnish an acceptable POC or otherwise achieve substantial compliance by December 9, 1999. CMS Ex. 9. Lineville apparently made no response to the November 29 letter because on December 9, 1999, CMS notified Lineville that it was imposing the following remedies recommended by ADPH: (1) denial of payment for new admissions, effective December 24, 1999; (2) a CMP of $50 per day for the period September 16 to November 4, 1999; and (3) a CMP of $100 per day from November 5, 1999 until Lineville achieved substantial compliance. CMS Ex. 10.

On January 19-20, 2000, a second revisit survey was performed, and Lineville was again cited for deficiencies. See Lineville Request for Review (RR) at 3. On February 23, 2002, ADPH conducted a third revisit survey and determined that Lineville was in substantial compliance with Medicare participation requirements as of February 22, 2000. Id.

C. The ALJ proceeding

In early February 2000, prior to the third revisit survey, Lineville requested an ALJ hearing, contending that there was no legal or factual basis for the six deficiency findings made by ADPH during the November revisit survey. In requesting the hearing, Lineville did not contest the findings made by ADPH during the surveys prior or subsequent to the November revisit survey. See Lineville RR at 3. In addition, Lineville did not allege that the CMPs imposed by CMS were unreasonable. See ALJ Decision at 24. An evidentiary hearing was held by the ALJ on February 5-6, 2002.

The ALJ Decision contains six numbered Findings of Fact and Conclusions of Law (FFCL), one for each of the deficiencies cited by ADPH. ALJ Decision at 5. In FFCL 1, the ALJ found that, as of the date of the November revisit survey, Lineville had failed to provide Resident 5 with an "ongoing program of activities" to meet his interests and physical, mental, and psychosocial well-being, as required by 42 C.F.R. � 483.15(f)(1). Id. at 6. In FFCL 2, the ALJ found that Lineville had failed to provide Resident 9 with necessary care to treat and prevent pressure sores, in violation of 42 C.F.R. � 483.25(c). Id. at 10. Based on these two FFCLs, ⁽²⁾ the ALJ concluded that Lineville was not in substantial compliance with Medicare participation requirements from September 16, 1999 to February 22, 2000, and that its noncompliance created a potential for more than minimal harm to residents. Id. at 25. Accordingly, the ALJ upheld the remedies imposed by CMS.

Issues

In this appeal, Lineville challenges both FFCLs 1 and 2. Lineville RR 4-20. CMS challenges FFCL 6, a determination by the ALJ that CMS had failed to prove a violation of 42 C.F.R. � 483.75(l)(1), which requires a facility to maintain complete and accurate clinical records. We address each of the challenged FFCLs in turn.

Standard of Review

Our standard of review on a disputed conclusion of law is whether the ALJ Decision is erroneous. Our standard for review on a disputed issue of fact is whether the ALJ decision as to that fact 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 (at http://www.hhs.gov/dab/ guidelines/); South Valley Health Care Center, DAB No. 1691 (1999), aff'd South Valley Health Care Center v. HCFA, 223 F.3d 1221 (10^th Cir. 2000).

Substantial evidence exists to support a factual finding "if a reasonable mind reviewing the evidence in the record as a whole could accept it as adequate to support his conclusion." Consolidated Edison v. NLRB, 305 U.S. 197, 229 (1938); Richardson v. Perales, 402 U.S. 389, 401 (1971). Regarding this standard, we have said that:

the reviewer must examine the record as a whole and take into account whatever in the record fairly detracts from the weight of the decision below. The reviewer does not, however, reweigh the evidence nor substitute his or her judgment for that of the initial decision-maker. Thus, the reviewer must not displace a "choice between two fairly conflicting views," even though a different choice could justifiably have been made if the matter had been before the reviewer de novo. The reviewer must, however, set aside the initial conclusions when he or she "cannot conscientiously find that the evidence supporting that decision is substantial, when viewed in the light that the record in its entirety furnishes, including the body of evidence opposed to the [initial decision-maker's] view." In addition, the Board has held that an ALJ need not "cite to everything in the record which supports" the findings, but that the "evidence that the ALJ does cite must support the findings made."

Carehouse Convalescent Hospital, DAB No. 1799, at 6 (2001) (citations omitted).

Issue 1 (FFCL 1): Whether substantial evidence supports the ALJ's finding that Lineville failed to provide an ongoing program of activities designed to meet Resident 5's needs and well-being.

Title 42 C.F.R. � 483.15(f)(1) states that a facility "must provide for an ongoing program of activities designed to meet, in accordance with the comprehensive assessment, the interests and the physical, mental, and psychosocial well-being of each resident." ADPH found -- and for reasons discussed below the ALJ agreed -- that Lineville had violated section 483.15(f)(1) by failing to provide Resident 5 with sufficient activities to prevent social isolation. CMS Ex. 2, at 7; ALJ Decision at 6, 10.

In her decision (at pages 6-8), the ALJ described the following undisputed facts and evidence: Resident 5 had medical problems that made him bed-bound and totally dependent on the nursing staff for transfers and most other daily activities. He suffered from dementia, depression, and impaired cognition. He had no immediate family. Despite his cognitive impairment, his speech was clear, and he could sometimes understand others and make himself be understood. According to a September 22, 1999 Minimum Data Set (MDS) assessment, he experienced periods of restlessness and exhibited calling-out behaviors indicative of depression, anxiety, and sad moods. CMS Ex. 4, at 62. These behaviors were interpreted by the nursing staff and others as an attempt to get people to visit him in his room. Tr. at 40, 328-29; CMS Ex. 4, at 12, 19, 21. Lineville's Director of Nursing, Susan Reynolds, testified that Resident 5 was a very lonely old man who wanted a lot of attention. Tr. at 272. Nurse Reynolds also described him as a "difficult resident" who would sometimes yell and use foul language with the nursing staff and attempt to strike those who helped him accomplish daily tasks. Id. In addition, she testified that he could not participate in large group activities because he would become agitated if there was too much stimulus. Tr. at 286.

Section N of the September 1999 MDS assessment states that on an average day Resident 5 was awake for most of the morning and afternoon; that he preferred to engage in activities in his room; and that his preferred activities included cards or other games, music, reading, spiritual or religious activities, watching TV, and talking or conversing. CMS Ex. 4, at 65. A February 1999 assessment identified similar activity interests. CMS Ex. 4, at 13-15. The February 1999 assessment also indicated that he was "available" to participate in activities for as many as 7.70 hours per day, but that his "pot[ential] for involvement in act[ivity]" was a "little less than of the time available." Id. at 14; see also Tr. at 331-32.

In the Statement of Deficiencies for the September survey, ADPH reported that during July and August 1999, Resident 5 had participated in -- and enjoyed -- activities involving interaction with other residents. ⁽³⁾ CMS Ex. 21, at 5; see also CMS Ex. 4, at 18-22; Tr. at 33, 332-37. In addition, ADPH reported that, between September 1 and September 15, 1999, Resident 5 was offered activities in his room on four occasions for ten minutes each, and that twice a month he was wheeled out of his room in his bed for group activity. CMS Ex. 21, at 6. Based on this information, ADPH found that the "frequency of attempts to get the resident out of the room (in spite of the positive results the times when taken out of the room involved in activities) was not consistent with the previous plan of care established for this resident," and that Lineville had "failed to plan for activities to prevent social isolation from others when the resident's interaction during the times when taken to activities indicated an enjoyment of being with others." Id.

In response to these findings, Lineville revised Resident 5's activity plan. See CMS Ex. 4, at 8; CMS Ex. 21, at 5. The revised activity plan, dated October 11, 1999, identified the following goal: "Involvement in act. will increase from 2x wkly to 4x wkly by next review 12/99." CMS Ex. 4, at 8. The plan listed specific "approaches" to achieving the goal, including group activities and in-room visits. ⁽⁴⁾ Id.

During the November revisit survey, ADPH reviewed the records of Resident 5's activities during October and early November 1999. Tr. at 40-41. These records (Lineville Exs. 8-10) show the following activities between October 11 and November 5:

October 13 1 hour of television
October 18 Pastor Abrams
October 21 30-minute church service
October 25 30-minute church service
October 28 2 hours of television
November 1 30-minute church service
November 3 staff turns on radio in room
November 4 First Assembly (church service)

The ALJ found that from October 14 to November 5, 1999, Resident 5 "was available for about 140 hours of activities" but "was provided only about five hours of activities during this period." ALJ Decision at 9. In addition, the ALJ found:

While Petitioner was in the process of increasing the activities of Resident 5, Petitioner was simply not providing sufficient interaction with other people or visual stimulation for Resident 5. I do not find that television provides either the type of interaction or visual stimulation Resident 5 needed, but Resident 5 did not even have television more than a few hours a week. For most of his time awake, he was lying in bed, doing absolutely nothing, with a staff member coming in every "hour or two." Petitioner did not provide any evidence to indicate why Resident 5 could not be wheeled in his bed relatively frequently to common areas where there may have been other residents. Nor did Petitioner provide evidence that Resident 5 was always disruptive in such settings. In fact, Petitioner's progress notes indicate that Resident 5 interacted appropriately with other residents during the group activities he had been provided.

Id. at 10 (emphasis added). Based on these findings, the ALJ concluded that Lineville had failed to show that it was in substantial compliance with section 483.15(f)(1) during the November revisit survey. Id. at 11.

Lineville now contends that the ALJ applied the wrong standard in assessing its compliance with 42 C.F.R. � 483.15(f)(1). Lineville RR at 4, 8. The correct standard, Lineville asserts, is not whether it was providing "enough" or "sufficient" activities in the reviewer's estimation, but whether the facility was furnishing activities in compliance with the October 11 activity plan. Id. at 8-10.

We reject this contention and find that the ALJ applied the correct standard in assessing Lineville's compliance with section 483.15(f)(1) and that her finding of noncompliance is supported by substantial evidence. The applicable compliance standard is found in the text of section 483.15(f)(1), which requires a facility to provide an ongoing program of activities "in accordance with the comprehensive assessment." In other words, the regulation requires an activity program commensurate with the patient's needs, capacities, and preferences, as revealed in the patient's assessment. In this case, the ALJ found that Resident 5 spent most of his waking hours "lying in bed, doing absolutely nothing," even though assessments and staff observations indicated signs of social isolation, and that Lineville had taken only minimal or inadequate steps to reduce that isolation or to provide the activities that he preferred or enjoyed. The ALJ also described evidence that Resident 5's social isolation had been exacerbated by padded bed siderail protectors (not removed until the survey) that obstructed his vision of the hall. Tr. at 43-44, 123, 125, 469-70. In addition, the ALJ found that Lineville had documented a mere five hours of activities during the 26 days from October 11 to November 5, despite Resident 5's availability for 140 hours of activity during that period. Considered together, these findings address whether Resident 5's activities and living conditions adequately met, or were commensurate with, his assessed needs and are therefore consistent with the applicable compliance standard.

Lineville cites Appendix PP of the CMS State Operations Manual (SOM) to support its contention that the October 11 activity plan establishes the appropriate compliance standard. Lineville RR at 8. However, Appendix PP's guidelines (entitled "Guidance to Surveyors") regarding section 483.15(f)(1) mirror the standard just described. They state that an activities program should be "multi-faceted and reflect each individual resident's needs," and that "an activities program should occur within the context of each resident's comprehensive assessment and care plan." CMS Ex. 19, at 6. Appendix PP also indicates, via a set of questions and investigative criteria, that an activity program provided "within the context" of a care plan and comprehensive assessment is one in which the type, frequency, and duration of the activities is consistent with the needs and interests of the patient and his or her capacity to participate in those activities. Id. at 6-7. In short, the guidelines in Appendix PP suggest that the needs and capacities of the resident, not the plan for meeting or accommodating those needs and capacities, provide the benchmark for assessing compliance with section 483.15(f)(1).

Lineville contends that the October 11 activity plan provides the appropriate compliance standard "because it is undisputed that the activities care plan complied with the Medicare requirements for a care plan as set out in 42 C.F.R. � 483.20(k)." Lineville RR at 10. We reject this contention because we do not agree that the plan's compliance with section 483.20(k) was undisputed. ADPH, in fact, made no finding whatsoever concerning the requirements in section 483.20(k). A failure to cite an otherwise noncompliant facility for violating a particular participation requirement does not constitute a certification or representation by the survey agency that a facility is compliant with that requirement. See 42 C.F.R. �� 488.24, 488.330. Moreover, nothing in the record indicates that ADPH or CMS represented to Lineville that implementation of the October 11 activity plan would suffice to establish substantial compliance with section 483.15(f)(1). See CMS Ex. 21. In fact, Lineville's POC contains no description of the plan or its goals; the POC states merely that Resident 5's activity plan would be revised. ⁽⁵⁾

Lineville complains that it is being unfairly held to a standard that required it to provide 7.7 hours of activities per day, the number of hours Resident 5 was "available" for activities. Lineville Reply Brief at 4-5. However, neither ADPH nor the ALJ adopted or applied such a numerical standard, neither assessed Lineville's compliance based solely on the number of hours of activities provided, and neither stated or implied that Lineville was obligated to occupy every one of Resident 5's available waking hours. The ALJ, for example, simply found that Lineville had provided an insufficient quality and quantity of activities given the time available for those activities and his assessed needs. In any event, the number of hours that Resident 5 was available for activities is a relevant consideration, because it is a measure of his assessed needs.

Lineville contends that ADPH cited it only for failing to follow its own activity plan, which, Lineville asserts, it did follow. See Lineville RR at 8; Lineville Reply Brief at 2-3. The Statement of Deficiencies for the November revisit survey does state that Lineville was cited for failing to provide activities at the "frequency established in the plan of care to prevent social isolation." CMS Ex. 2, at 7. However, the Statement of Deficiencies also states that Lineville had failed to provide activities "in accordance with [Resident 5's] assessment." Id. In addition, the ADPH surveyor, Lucinda Ashley, a registered nurse, testified that she cited Lineville for violating section 483.15(f)(1) based on its failure to provide sufficient activities to prevent social isolation. Tr. at 116; see also CMS Ex. 2, at 4. We therefore do not agree that Lineville was cited only for failing to follow the October 11 activity plan.

We note parenthetically that the activity plan provided an inadequate or unclear standard of compliance. The plan called upon Lineville to increase the frequency of Resident 5's activities from two to four times per week, but it did not specify what the quality or duration of those activities should be in light of his assessed needs (particularly his need for social stimulus) and availability. CMS Ex. 4, at 8. Despite an assessment indicating that he had time each day for activities, the plan also failed to specify the minimum that could or should be done for him on a daily basis. Instead, the plan simply listed several approaches that could be taken to increase his "activity," some of which do not necessarily involve social interaction. Id. Under the circumstances, the ALJ could reasonably have concluded that the plan was a wholly inadequate response to the needs of a bedfast and dependent resident who suffered from depression, exhibited signs of social isolation, had infrequent visits from family or friends, and was brought out of his room rarely if ever.

To the extent that the goals in the activity plan were clear, Lineville was not meeting them. Lineville contends that it "was already meeting its goal of providing two to four activities per week when the November revisit survey occurred, despite the fact that the facility still had more than a month left to meet its goal." Lineville RR at 6. This contention is based on an unreasonably narrow interpretation of the activity plan. Because Lineville had been advised during the September survey that its activity program for Resident 5 was insubstantial (consisting of brief, infrequent forays outside his room) and had failed to address an apparent need for social interaction, it is unreasonable to suggest that the October 11 activity plan merely required Lineville to provide two to four discrete "activities" per week, no matter how brief or insignificant. Giving Resident 5 two chances per week to, say, watch television would not have met his need for social interaction. Instead, the plan is most reasonably read as requiring Lineville to increase the number of days during which Resident 5 was given the opportunity for substantial, sustained activity. Lineville did not show that it met that goal. As indicated, it documented a mere five hours of activity during the 26 days from October 11 to November 5. Lineville Ex. 8-10. Three of the five hours involved no social interaction. No documented group or social activity lasted more than 30 minutes, and there was no day on which he engaged in more than one such activity.

Even if we accept the contention that the activity plan goal was simply to increase the number of discrete activities, Lineville failed to establish that even this goal was met. The plan required Lineville to increase Resident 5's "activities" from two to four per week. Its documentation, however, shows no more than two significant activities per week between October 11 and November 5. ⁽⁶⁾

Lineville points to testimony by Director of Nursing Reynolds that Lineville's staff, social workers, and volunteers regularly visited Resident 5. Lineville RR at 6-7. Although the ALJ did not comment on this testimony (see ALJ Decision at 9-10), she could have reasonably accorded it little, if any, weight. None of the alleged visits was observed by Nurse Reynolds, and none was documented on Resident 5's chart. See Tr. at 340-41. Moreover, Lineville was on notice of its need to increase the quality and quantity of Resident 5's activities as a result of the September 1999 survey. Lineville also had constructive knowledge of the guidelines in Appendix PP of the SOM, which communicate the importance of record-keeping by instructing surveyors to review clinical and attendance records to verify responses to activities identified in the progress notes. CMS Ex. 19, at 7. In light of these guidelines and ADPH's findings during the September survey, the absence of any documentation of the room visits mentioned by Nurse Reynolds is a strong indication that they did not in fact occur.

For the reasons above, we conclude that the ALJ applied the correct legal standard in assessing compliance with section 483.15(f)(1), and that there is substantial evidence in the record to support the ALJ's finding that Lineville failed to provide an ongoing program of activities designed to meet the interests and physical, mental, and psychosocial well-being of Resident 5. Accordingly, we affirm FFCL 1.

Issue 2 (FFCL 2): Whether substantial evidence supports the ALJ's finding that Lineville failed to provide necessary treatment or services to a resident with a history of pressure sores.

A nursing facility's obligations regarding the treatment or prevention of pressure sores are set forth in 42 C.F.R. � 483.25(c), which states:

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.

As did the survey agency, the ALJ concluded that Lineville had violated section 483.25(c)(2) chiefly because it allowed a resident susceptible to skin breakdown to wear an ill-fitting orthotic boot that came into direct contact with the skin. ALJ Decision at 13; CMS Ex. 2 at 11. In support of this conclusion, the ALJ relied upon the facts and evidence described below. See generally ALJ Decision at 10-13.

Resident 9 had diabetes, peripheral vascular disease, and other conditions that made him susceptible to pressure sores, particularly in his lower extremities. Tr. at 46-47, 127, 194-95. Upon his admission to Lineville in 1997, he had a serious pressure sore on the left heel that was successfully treated. Tr. at 288-290.

In August 1999, an MDS assessment revealed that Resident 9 had two stage I pressure sores, and that he received preventive and protective foot care to prevent new sores from developing. CMS Ex. 5, at 28. His plan of care specified that he wear orthotic footwear (variously described as Meda boots, EZ boots, or Multi-Podus boots) at all times to eliminate pressure on the heels and to prevent pressure sores from developing at those sites. CMS Ex. 5, at 11, 28, 30-36; CMS Ex. 2, at 8; Tr. at 46-47.

On October 24, 1999, Lineville's nursing staff reported a "blood blister" on Resident 9's left heel. CMS Ex. 5, at 16. That same day, a physician ordered the nursing staff to treat the heel with Granulex, a topical spray that lubricates the skin, prevents infection, and stimulates blood supply. Id. at 5; Tr. at 387.

On November 4, 1999, Surveyor Ashley observed Resident 9 wearing Multi-Podus boots on both feet without any socks. Tr. at 48-50. She testified that the boots were old and worn; that she saw an uncovered, darkened pressure sore on his left heel; and that the heel was resting in direct contact with the metal frame of the boot. Tr. at 48-52. Surveyor Ashley advised the nursing staff of her observations, whereupon a nurse readjusted the boot. Tr. at 52-53; CMS Ex. 2, at 10.

On November 4, Dr. Smith, Lineville's medical director, wrote a progress note describing his evaluation of Resident 9's left heel. CMS Ex. 5, at 9; Tr. at 354. Dr. Smith indicated in the progress note that the wound or lesion on the heel looked like a blood blister but also said:

There is a blood blister on the left heel that blanches out around it. I think the blister is the early stages of a pressure sore, however, he is in a boot all of the time and there is no way he can get a pressure sore there. Patient may just have bumped it someway that caused it to bleed under the skin and that is old blood now under the skin. P: Treat this vigorously as a Stage 2 pressure sore thinking that might be what we are dealing with, but it is certainly no more than a Stage 2.

CMS Ex. 5, at 9.

In response to treatment ordered by Dr. Smith, a scab formed on Resident 10's left heel. On November 8, the scab fell off, revealing healthy pink skin underneath. CMS Ex. 5, at 18.

During the proceedings before the ALJ, both parties submitted evidence about whether the lesion on Resident 9's left heel was a "blood blister" or a "pressure sore." The ALJ found that the dispositive issue regarding Resident 9 was not whether his heel "lesion" was a blister or a pressure sore, but "whether [Lineville] was complying with the requirement to prevent new sores from developing." ALJ Decision at 12. The ALJ later noted that the lesion was a condition that "can be described" as a pressure sore. Id. at 13. In addition, the ALJ found Resident 9's boot "was not correctly placed on his [left] foot" on November 4; that the "improper fitting boot directly caused" the lesion on the left heel; that the lesion was "preventable" had the boots fit properly; and that Lineville "did not demonstrate that Resident 9's lesion was unavoidable if Resident 9's orthotic boot had been placed on his foot correctly." Id. at 12-14. The ALJ also found that Lineville was required to show that the lesion was unavoidable but that no such showing was made. Id. at 14. Based on these findings, the ALJ concluded that Lineville had failed to ensure that Resident 9 "received necessary assessments, treatments, and services to promote healing, prevent infection, and prevent new sores from developing," in violation of section 483.25(c)(2). Id.

Lineville contends that CMS failed to prove a violation of section 483.25(c)(2) because Resident 9 did not, in fact, have a "pressure sore" at the time of the survey. Lineville RR at 14. In addition, Lineville contends that the ALJ committed a legal error in finding that the existence or nonexistence of a pressure sore during the survey was immaterial for purposes of determining the facility's compliance with section 483.25(c). For the reasons below, these contentions do not persuade us to disturb the ALJ's conclusion that Lineville was in violation of that regulation during the November revisit survey.

First, there is substantial evidence in the record to support the ALJ's implied finding that, during the November revisit survey, Resident 9 had a pressure sore or a healing pressure sore on his left heel. A stage II pressure sore is defined in the MDS assessment (and in Appendix PP of the SOM) as a "[a] partial thickness loss of skin layers that presents clinically as an abrasion blister, or shallow crater." CMS Ex. 5, at 28 (emphasis added). CMS's expert witness, Dr. Richard Esham, a board-certified internist, testified that the lesion on Resident 9's left heel was a pressure sore which could have been caused by the resident's ill-fitting orthotic boot. Tr. at 196, 198. Dr. Esham also testified that all blood blisters are pressure sores. Tr. at 193-94, 212-19, 227. In addition, there was evidence that Lineville's medical director (Dr. Smith) and Resident 9's attending physician identified and treated Resident 9's blister as a stage II pressure sore. Tr. at 386-87, 394; CMS Ex. 5, at 5 (indicating that Granulex was prescribed to treat the "blood blister" found on October 24).

Relying on the testimony of Dr. Smith, Lineville contends that the existence of the scab on Resident 9's heel is proof that the blood blister was not a pressure sore. Lineville RR at 15. Dr. Smith testified that pressure sores and blood blisters have different causes: a blood blister is caused by sudden trauma, a pressure sore by prolonged pressure on the affected area of skin resulting in lack of blood to that area. Tr. at 382-87. In addition, Dr. Smith testified that pressure sores do not form scabs (dried blood) that fall off but instead form eschars that must be surgically debrided. Id. Dr. Smith also stated that he found it clinically significant that healthy, pink skin was found when the scab fell off on November 8 because "maybe [the lesion] was getting blood supply to that area from the start." Tr. at 386.

We cannot say that Dr. Smith's testimony compels a finding contrary to the conclusion reached by Dr. Esham that Resident 9 had a pressure sore on his left heel. Dr. Esham's characterization of the heel lesion is not inconsistent with CMS's survey guidelines, which state that a pressure sore may clinically appear to be a blister. SOM Appendix PP (guidelines under Tag 314). In addition, Dr. Smith reported in his November 4 progress note that there was "blanching" around the heel lesion and later testified that blanching is a clinical sign of a pressure sore. ⁽⁷⁾ See CMS Ex. 5, at 9; Tr. at 384. We further note that medical diagnosis is, to some degree, a problematic endeavor -- Dr. Smith admitted his uncertainty about whether the heel lesion was a blood blister or a pressure sore -- so we find it significant that Resident 9's physicians chose to treat the lesion as a pressure sore. Moreover, only speculation was offered about the cause of the lesion. Finally, the appearance of healthy skin on November 8 does not necessarily prove that the left heel lesion was not, in its early stages, a pressure sore. Aggressive treatment with Granulex, which stimulates blood supply, could account for the healthy skin observed on November 8. See Tr. at 387. Under the circumstances, we reaffirm our finding that "substantial evidence" -- evidence that a reasonable mind might accept as adequate -- supports the ALJ's finding that Resident 9 had a pressure sore on his left heel.

As for the assertion that the ALJ committed a legal error in applying section 483.25(c)(2), we agree with the ALJ that the existence of a pressure sore at the time of the survey was immaterial. We reject Lineville's assertion that a facility violates section 483.25(c)(2) only if a pressure sore is discovered at the time of the survey. No such timing requirement appears in the regulation. Section 483.25(c)(2) states only that a resident "having pressure sores" receive necessary treatment to promote healing, prevent infection, and prevent new sores from developing. We read this language as requiring evidence of a pressure sore at any point during the resident's stay in the facility; CMS need not show, as Lineville would require, that a pressure sore existed at the time of the survey. Adopting Lineville's interpretation of section 483.25(c)(2) would, in cases involving residents whose pressure sores healed prior to the survey, effectively preclude CMS from enforcing the regulation's requirement that a facility provide necessary care to prevent new pressure sores from forming.

In this case, it is undisputed that Resident 9 was susceptible to pressure sores, that Lineville had treated Resident 9 for pressure sores while in the facility, and that his plan of care called for necessary measures to prevent their recurrence, including the wearing of orthotic boots. Under these circumstances, a failure to satisfactorily implement the required preventive measures would violate Lineville's obligation under section 483.25(c)(2) to provide care or treatment to "prevent new sores from developing."

Lineville contends that it provided such treatment and "did everything within its power to prevent Resident #9 from developing" pressure sores. Lineville RR at 17-20. However, the plan of care called upon Lineville to ensure that Resident 9 wore a properly fitting orthotic boot -- whose purpose was to eliminate any pressure on the skin -- at all times. Lineville does not dispute the necessity of this preventive measure. In addition, Surveyor Ashley gave undisputed testimony that, on November 4, Resident 9 was wearing an ill-fitting orthotic boot that was in direct contact with his heel, and Dr. Esham testified that such contact likely impaired the healing process. Tr. at 48-50, 198. This is substantial evidence that Lineville had failed to render necessary treatment to promote healing and prevent new pressure sores from forming. See Ridge Terrace, DAB No. 1834 (2002) (finding that a single observation of a nurse's aide cleaning an open sore area with a stool-stained washcloth was sufficient to sustain a deficiency finding).

Lineville suggests that the boots were not ill-fitting, relying primarily on the testimony of Jackie Floyd (an occupational therapist), who testified that she examined Resident 9 in April 1999 and again on November 11 and determined that his boots fit well and were not causing problems. See Lineville RR at 18. However, we agree with the ALJ that this evidence "did not answer the question of whether the boots Resident 9 was wearing at the time he was observed by the surveyor were the same orthotic boots for which Ms. Floyd had assessed the fit." ALJ Decision at 13. Ms. Floyd could not identify the brand of boot she observed on April 15, and she described the boots she saw on November 11 as "telescoping" foot splints, not the Multi-Podus boots that the surveyor observed him wearing on November 4. See Tr. at 48, 405-10, 471; Lineville Ex. 22, at 3, 5. In addition, Surveyor Ashley reported being told by Lineville staff that Resident 9 had many pairs of boots. Tr. at 49, 471; CMS Ex. 2, at 10. Lineville asserts that its Director of Nursing, Susan Reynolds, gave undisputed testimony that Resident 9 had only one pair of orthotic boots, and these were the boots that Resident 9 was seen wearing on April 15, November 2-5, and November 11, 1999. Lineville RR at 19. However, we agree with CMS that Lineville mischaracterized Nurse Reynolds' testimony, which consisted of answers to unclear and ambiguous leading questions about whether Resident 9 had ever changed his boots. See Tr. at 374-75. We also agree with the ALJ that "Ms. Floyd's assessment of boots that had been placed on Resident 9's heels correctly proves nothing about the way the boots were placed on Resident 9's heels at other times." ALJ Decision at 13.

Finally, Lineville contends that the ALJ erroneously required it to demonstrate that the lesion on Resident 9's left heel was "clinically unavoidable." Lineville RR at 16-17. Lineville contends that this standard is applicable only to violations of section 483.25(c)(1), which specifies a facility's obligations to a resident who enters a facility without pressure sores. Id. However, we have held that "once surveyors identify a resident with pressure sores, it is incumbent on the long-term care facility to demonstrate that such sores were unavoidable." Cross Creek Care Center. Section 483.25 does not limit the applicability of the unavoidability defense to cases involving residents who are admitted to the facility with pressure sores. We see no material difference between a susceptible person who enters a facility without pressure sores but later develops them, and a person (like Resident 9) who enters a facility with pressure sores, is successfully treated, then develops another sore while still in the facility. In either case, the facility violates the requirement to prevent new pressure sores from developing unless it can show that the pressure sore was unavoidable. Cf. SOM Appendix PP (Guidance to Surveyors) (noting that a pressure sore can be considered unavoidable only if routine preventative and daily care is provided). See SOM Appendix PP (Guidance to Surveyors).

In any event, unavoidability is a tangential issue in this case because the thrust of ADPH's deficiency finding was not Lineville's failure to prevent the left heel pressure sore, but its failure to take the steps called by the plan of care to promote healing and prevent additional sores from forming. Because there is substantial evidence that Lineville did not take these necessary steps, we affirm FFCL 2.

Issue 3 (FFCL 6): Whether CMS established that Lineville failed to maintain complete and accurate clinical records regarding Resident 10.

Title 42 C.F.R. � 483.75(l)(1) provides that a nursing facility must "maintain clinical records on each resident in accordance with accepted professional standards that are -- (i) [c]omplete; (ii) [a]ccurately documented; (iii) [r]eadily accessible; and (iv) [s]ystematically organized." ADPH found (under tag F514) that Lineville was not in substantial compliance with section 483.75(l)(1) because it failed to maintain a complete or accurately documented record of Resident 10's seven-day voiding pattern. CMS Ex. 2, at 17-19.

Resident 10, a male, was admitted to Lineville on October 26, 1999, approximately one week before the November revisit survey. CMS Ex. 6, at 16. Upon admission, he was occasionally incontinent of bladder. Id. at 14, 17, 25. To address this problem, the plan of care directed the nursing staff to evaluate him for an "appropriate bowel and bladder training program." Id. at 12. On November 2, a bowel and bladder assessment revealed that he continued to have occasional incontinence of bladder and that a program of scheduled bowel and bladder assistance (to prompt his use of the bathroom) would be developed to help him maintain continence. Id. at 8-9, 14. Accordingly, the plan of care was amended to require the nursing staff to monitor his voiding pattern for seven days. Id. at 12.

Surveyor Ashley and Nurse Reynolds testified that prompting a resident to use the bathroom at designated times can help a resident maintain continence. Tr. at 77-80, 320-21. In order to determine when this prompting should occur, the resident's voiding activity is monitored and documented over a period of time to determine whether a pattern exists. Id. If a pattern exists, a schedule is developed to ensure that the nursing staff renders toileting assistance when the resident needs it, preferably before the resident has urinated or defecated on himself. Id.

The monitoring of Resident 10's voiding pattern was recorded by certified nursing assistants (CNAs) on a document labeled "7-Day Pattern Setting" (which we refer to as the "Pattern Setting form"). CMS Ex. 26; Tr. at 80-81. At the hearing, Nurse Reynolds confirmed that her nursing staff uses the entries on the Pattern Setting form to determine whether a resident's bowel and bladder habits exhibit a pattern that can be used to establish a toileting schedule. Tr. at 260, 324-25.

In accordance with the amended plan of care, Lineville began to monitor Resident 10's voiding activity on November 2, 1999. CMS Ex. 6, at 12, 14. Lineville's protocol called for hourly observations of the resident to determine whether he was incontinent or needed toileting assistance. Tr. at 79-80; CMS Ex. 26.

At approximately 6:00 p.m. on November 3, 1999, Surveyor Ashley copied and reviewed Resident 10's Pattern Setting form. Tr. at 80-81. There were no entries for the previous day, November 2, after 3:00 p.m. CMS Ex. 26. The entry for 9:00 a.m. on November 3 indicated that Lineville's staff had checked Resident 10 and found him to be dry. Id. However, at that time, Surveyor Ashley observed a nursing aide changing Resident 10's diaper, which was soiled with urine and diarrhea. Tr. at 74-75, 82, 445. Lineville conceded that the Pattern Setting form was not complete, particularly for November 2 and November 3. Lineville Brief in Response to CMS's RR at 3; Tr. at 259-60. In addition, a nursing note dated November 11 states that the Pattern Setting form was "inaccurate." CMS Ex. 6, at 15.

Lineville argued at the hearing that the Pattern Setting form (CMS Ex. 26) is not a "clinical record" for purposes of section 483.75(l)(1), and thus there is no factual basis for a deficiency finding under that regulation. The ALJ agreed, finding that the Pattern Setting form was a mere "tool" used by CNAs to track Resident 10's voiding pattern, and noting that CMS had "provided no evidence of the professional standards that would require the Pattern Setting form to be part of the clinical records or to be accurate and complete." ALJ Decision at 24. We find, however, that the ALJ erred in not viewing the form as an inaccurate and incomplete clinical record.

The regulations do not define the term "clinical record," but section 483.75(l)(5) does say that a clinical record "must contain" a "record of the resident's assessments" (emphasis added), among other things. Resident assessments are discussed in section 483.20, which states that a facility must make a "comprehensive assessment" of a resident's needs and functioning, using a resident assessment instrument (RAI). ⁽⁸⁾ 42 C.F.R. � 483.20(b)(1). Such an assessment must include information about the resident's "continence," "behavior patterns," "cognitive patterns," and other aspects of functioning. 42 C.F.R. � 483.20(b)(ix). In addition, section 483.20 requires the facility to "maintain all resident assessments" and "use the results of the assessments to develop, review, and revise the resident's comprehensive care plan." 42 C.F.R. � 483.20(d).

Although we do not decide here that the term "assessment" in section 483.75(l)(5) refers solely to the "comprehensive assessment" described in section 483.20(b), we note that section 483.75(l)(5) does not set forth a complete list of the documents that are part of the clinical record. Because that regulation simply lists certain items that must be included, it is reasonable to assume that any items similar in purpose and function to the listed items should also be deemed part of the clinical record. As indicated in section 483.20, the chief purpose of an "assessment" is to gather information about a resident's habits, "patterns" (see e.g., 42 C.F.R. � 483.20(b)(1)(vi)), or functioning, so that the information can be used to develop or revise an appropriate plan of care. The Pattern Setting form in this case serves that purpose: it required Lineville's nursing staff to gather information about an aspect of Resident 10's functioning -- information that would be used to direct his care (i.e., to develop and institute a scheduled toileting program or, if a scheduled program was not feasible, to provide the basis for identifying other steps to control his incontinence). For this reason, we find that the Pattern Setting form was part of the clinical record.

Our conclusion that the Pattern Setting form was a clinical record is supported by the guidelines in Appendix PP of the SOM. These guidelines state that "[a] complete clinical record contains an accurate and functional representation of the actual experience of the individual in the facility," and must "contain enough information to show that the facility knows the status of the individual, has adequate plans of care, and provides sufficient evidence of the effects of the care provided." CMS Ex. 19, at 17. The guidelines also instruct surveyors to consider the following questions:

• Is there enough record documentation for staff to conduct care programs and to revise the program, as necessary, to respond to the changing status of the resident as a result of interventions?

• How is the clinical record used in managing the resident's progress in maintaining or improving functional abilities and mental and psychosocial status?

SOM Appendix PP (guidance under Tag F514) (emphasis added). Viewed in light of the regulations, these guidelines provide that a document is part of the clinical record if it is used in some significant way to assess the resident's need for medical treatment or maintain the resident's health, safety, and psychosocial well-being. As indicated, the Pattern Setting form was used in this way.

In addition to finding that the Pattern Setting form was a clinical record, we find that it was not maintained in accordance with accepted professional standards. The professional standard in this case was established by the plan of care, which required Lineville's nursing staff to chart Resident 10's voiding pattern in order to design a toileting schedule. Lineville's Director of Nursing admitted that the voiding pattern record would be the basis for designing the toileting schedule. Tr. at 320-22, 325. In addition, Surveyor Ashley, a registered nurse, gave uncontradicted testimony that professional standards require an accurate and complete record of Resident 10's voiding pattern under these circumstances. Tr. at 171. Indeed, the mere existence of the Pattern Setting form, which called for entries each hour concerning the Resident's continence, is itself evidence of a professional standard requiring those entries.

Lineville asserts that "[t]here is absolutely no regulatory requirement that a CNA document each time" a resident is checked for incontinence, that a CNA is not permitted to make progress notes in a resident's clinical record, and that the document was kept in a separate notebook for CNAs. Lineville Brief in Response to CMS RR at 3-4. Relying on witness testimony, ⁽⁹⁾ Lineville also asserts that it was up to the nursing home to determine what documents become part of a patient's clinical record. Id. at 4. However, a facility's characterization of a document, or the protocols used to generate or maintain it, is irrelevant under the criteria set out above. What matters is the significance of the document (and the information in it) for the resident's care or treatment.

The fact that a "regulatory requirement" did not require CNAs to complete the Pattern Setting form is also irrelevant. Professional treatment standards and the resident's medical circumstances determine when a facility must generate a document and maintain it as a clinical record. For example, a facility need not perform and record two- or four-hour temperature checks for a resident whose vital signs and overall condition are stable. However, if the resident is running a fever or exhibiting other signs of medical instability, then a written record of periodic temperature checks would likely be required and maintained in the resident's clinical record to enable caregivers to assess the effectiveness of treatment and prevent further deterioration.

Lineville asserts that even if it failed to maintain an accurate and complete "clinical record" within the meaning of section 483.75(l)(1), it was nevertheless in substantial compliance with that regulation because the deficiency did not create the potential for more than minimal harm. Lineville Brief in Response to CMS RR at 5. The record shows otherwise. Surveyor Ashley and Nurse Reynolds testified that the purpose of the Pattern Setting document was to provide the nursing staff with the information necessary to anticipate Resident 10's need to use the toilet, develop a scheduled toileting program to address that need, and thus prevent episodes of incontinence. Tr. at 77-83, 260, 320-25. Surveyor Ashley testified that incomplete or inaccurate entries on such a document make it difficult or impossible to know a resident's true bowel and bladder habits, increasing the risk of incontinence episodes. See Tr. at 81-83. Surveyor Ashley also testified that failure to develop an effective scheduled toileting program (a program based on information in the Pattern Setting form) increases the risk that a resident will become progressively more incontinent, and that incontinence undermines a resident's sense of dignity and self-esteem and can lead to physical problems, such as infections and impaired skin integrity. Tr. at 82-83; see also 321-22. In short, the testimony established that failure to accurately identify a voiding pattern may prevent a facility from developing an effective toileting program, thereby increasing the risk of persistent or increasing incontinence and its attendant consequences, which, if they occurred, would cause more than minimal harm. Consequently, we find that Lineville's failure to maintain a complete and accurate Pattern Setting form created the potential for more than minimal harm.

Lineville asserts that "even if a full and complete 7-day voiding pattern were necessary, it would only take at most an additional 7 days to complete one," and that "a delay of seven days during which a resident was being checked every hour could not possibly present a potential for more than minimal harm." Lineville Brief in Response to CMS RR at 6. This contention ignores that the deficiency finding under section 483.75(l)(1) was based on inaccuracies or omissions that created the potential for harm. There was a potential for harm in part because the Pattern Setting form could not have been completed within the original seven-day timespan. Undoubtedly Lineville could have taken steps to complete the Pattern Setting form after November 3 (the day ADPH discovered the deficiency). However, as of November 3, two days of entries on the Pattern Setting form were either incomplete or inaccurate, making it impossible for Lineville to provide the appropriate continency training after the original seven days specified by the form and increasing the risk that Resident 10 would become permanently or progressively more incontinent. There was also a potential for harm because, on November 3, there was no reason to believe that Lineville would in fact produce an accurate record of Resident 10's voiding pattern for the ensuing seven days.

Because we find that the Pattern Setting form was a clinical record that was not complete and accurate or otherwise maintained in accordance with professional standards, and because this inaccurate and incomplete form created the potential for more than minimal harm, we reverse the ALJ's determination regarding Tag F514 and conclude that Lineville was not in substantial compliance with the participation requirement set forth in 42 C.F.R. � 483.75(l)(1). ⁽¹⁰⁾

Issue 4: Whether there was a basis for the remedies imposed against Lineville.

Lineville contends that, if it was in substantial compliance with Medicare participation requirements during the November revisit survey, there is no legal basis to impose any remedies for the period between September 16, 1999 (the date of the annual survey) and February 22, 2000 (the date of the third revisit survey). We find it unnecessary to address this contention because we are affirming the ALJ's findings that Lineville was not in substantial compliance during the November revisit survey. ⁽¹¹⁾

Conclusion

We affirm the ALJ's findings that Lineville failed to comply with the participation requirements in 42 C.F.R. �� 483.15(f)(1) and 483.25(c). In addition, we reverse FFCL 6 and substitute the following finding:

Lineville failed to maintain a complete and accurate written record of nursing services -- namely, the monitoring of Resident 10's voiding pattern -- being provided to maintain the resident's continence. The record of Resident 10's voiding pattern (CMS Ex. 26) is a "clinical record" within the meaning of 42 C.F.R. � 483.75(l)(1) because it was to be used to direct his care. Because this clinical record was not complete or accurate, Lineville was not in substantial compliance with section 483.75(l)(1) during the November revisit survey.

For these reasons, we sustain the remedies imposed by CMS.

Cecilia Sparks Ford

Marc R. Hillson

Donald F. Garrett
Presiding Board Member

1. CMS was previously named the Health Care Financing Administration (HCFA). See 66 Fed. Reg. 35,437 (July 5, 2001). We use the name "CMS" in this decision unless we are quoting documents that refer to HCFA.

2. The ALJ set aside the other four deficiency findings. ALJ Decision at 14, 17, 21, 23.

3. During the September 1999 survey, Resident 5 was identified as Resident 2. See CMS Ex. 21, at 4-6.

4. The listed approaches were: (1) "Provide 2 group acts per wk. Church service, large group parties for socialization"; (2) "In room [visits two times per week] (thru) games, gospel music, bible reading, social [visits]"; (3) "Act[ivity]. calendar posted in room and read to him wkly"; (4) "Staff to reminisce about painting on ceiling"; (5) "Nsg. staff will roll his bed to act[ivities]"; (6) "Act. director [visit] PRN"; (7) "SS Director [visit] PRN"; (8) "Act[ivity] staff will provide him with TV/VCR cart wkly to watch movies in his rm."; (9) "Radio/Gospel music will be provided wkly at his bedside per act. staff"; and (10) "Volunteers will visit PRN." CMS Ex. 4, at 8.

5. Implementation of an approved POC does not, by itself, establish substantial compliance with a participation requirement. Cross Creek Health Care Center, DAB No. 1665 (1998); Warren Barr Pavilion of Illinois, DAB No. 1705 (1999). In Warren Barr, the nursing facility argued that implementation of the POC was sufficient to demonstrate that the underlying deficiencies had been corrected because CMS's acceptance of the POC was tantamount to an agreement on the criteria for a finding of substantial compliance. We rejected that argument, saying (in footnote 3):

The decision in Cross Creek clearly stated that even when a POC is accepted, a facility "is not regarded as in substantial compliance until HCFA determines, usually through a revisit survey, that the deficiency no longer exists." Thus, substantial compliance depends on a factual assessment that the pre-existing deficiency has been eliminated, not merely on determining that the POC has been complied with and no new deficiencies discovered. [internal citations omitted]

6. The fact that Lineville gave itself an additional month to meet the goal is irrelevant. As indicated, mere submission and acceptance of a POC does not establish that a cited deficiency has been corrected.

7. Dr. Smith testified that "[c]lassic pressure sores start out with redness on the skin and the skin breaks down and you see a blanching then on the skin from lack of blood supply and then the skin will necrose . . . ." Tr. at 384.

8. We have noted that the term "comprehensive assessment" is a term of art in the statute and regulations. See Cross Creek Health Care Center at fn. 8. "Comprehensive assessment" refers to the evaluation process which is statutorily mandated to be performed within 14 days of arrival at the facility pursuant to a protocol promulgated or approved by CMS. Social Security Act �� 1819(b)(3), 1819(e)(5), and 1819(f)(6)(B).

9. Director of Nursing Reynolds testified that the facility determines how to document and what is included in the clinical record, and that a CNA may not make a progress note in that record. Tr. at 257.

10. Even if Lineville was shown to have been in substantial compliance with this requirement, the facility's other deficiencies would support the remedies imposed by CMS and the ALJ.

11. Lineville's argument concerning the legal basis for CMS's remedies is based squarely on a contention that it was in substantial compliance during the November revisit survey. For example, on pages 22 and 23 of its request for review, Lineville states: "The timeline of events . . . clearly reveals that but for the Survey Agency's erroneous determination that Lineville was not in compliance with the applicable Medicare conditions of participation at the First Revisit Survey, no remedies would have been recommended by the Survey Agency and no remedies would have been imposed on Lineville by CMS. . . . Where the parties disagree is on the question of whether the CMPs imposed by CMS for the period of September 16, 1999 through November 4, 1999 (at a rate of $50 per day) and the period of January 21, 2000 through February 22, 2000 (at a rate of $100 per day) should be vacated if Lineville is found to have been in substantial compliance as of November 5, 1999 at the First Revisit Survey."