SUBJECT: Spring Meadows Health Care Center,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

On December 2, 2003, Spring Meadows Health Care Center (Spring Meadows) appealed a July 9, 2003 decision (as amended on January 13, 2004) by Administrative Law Judge (ALJ) Anne E. Blair. Spring Meadows Health Care Center, DAB CR1063 (2003) (ALJ Decision) and DAB CR1130 (2004). The Centers for Medicare & Medicaid Services (CMS) had determined, based on a June 1999 survey, that Spring Meadows was not in substantial compliance with Medicare participation requirements. After an evidentiary hearing, the ALJ concluded that Spring Meadows was not in substantial compliance with the requirements in 42 C.F.R. � 483.13(c) that a facility investigate and report suspected abuse of residents (although she concluded that CMS did not show that Spring Meadows failed to meet the requirement in that section that a facility develop and implement policies that prohibit abuse and neglect). The ALJ also concluded that Spring Meadows was not in substantial compliance with the requirement in 42 C.F.R. � 483.25 that each resident receive necessary care and services to attain or maintain his/her "highest practicable" well being. The ALJ upheld CMS's determination that Spring Meadows' noncompliance was serious enough to place residents in "immediate jeopardy." In addition, the ALJ found that the state of immediate jeopardy lasted from April 24 through June 7, 1999. Finally, the ALJ found that the amount of the CMP imposed by CMS for the period of noncompliance -- $5,000 per day -- was unreasonable and therefore reduced it from $5,000 to $3,050 per day, for a total CMP of $137,250.

CMS did not appeal the ALJ's conclusion regarding the requirement that a facility develop and implement policies that prohibit abuse and neglect. Spring Meadows did not appeal the ALJ's conclusion that Spring Meadows failed to investigate and report suspected abuse, but did appeal the remaining conclusions in the ALJ Decision. Spring Meadows contends that the ALJ violated its due process rights by basing her conclusion regarding section 483.25 on factual grounds of which Spring Meadows had no prior notice. Spring Meadows also contends that the ALJ erred in affirming CMS's immediate jeopardy determination. In addition, Spring Meadows contends that, if its deficiencies placed residents in immediate jeopardy, this level of noncompliance lasted for no longer than one day.

For the reasons stated below, we affirm the ALJ's conclusion that Spring Meadows was not in substantial compliance with section 483.25. While the ALJ improperly based this conclusion on grounds about which Spring Meadows received no pre-hearing notice, this procedural error was not prejudicial. CMS relied on other grounds to support its finding of noncompliance under section 483.25, including the facility's failure to recognize a head injury to a resident and to provide neurological assessments of the resident following the injury, consistent with its own policy. Spring Meadows had adequate notice of those grounds and ample opportunity to develop the record in response, yet failed to show by a preponderance of the evidence that it complied substantially with section 483.25. Thus, we modify the ALJ Decision by setting out new findings to support the conclusion that Spring Meadows was not in substantial compliance with section 483.25. In addition, we affirm the ALJ's remaining conclusions under appeal (although modifying somewhat the analysis regarding immediate jeopardy). Accordingly, we uphold the CMP of $3,050 per day from April 24 to June 7, 1999.

I. Regulatory Background

Spring Meadows is a skilled nursing facility (SNF) that participates in the Medicare program. Medicare's participation requirements for SNFs and other long-term care facilities are set forth in 42 C.F.R. Part 483. Compliance with Medicare participation requirements is verified through surveys performed by state agencies in accordance with the requirements in 42 C.F.R. Part 488, subpart E. A survey agency reports any "deficiency" (that is, a failure to meet a participation requirement) it finds on a standard form called a "Statement of Deficiencies" (SOD). See 42 C.F.R. �� 488.325(a), 488.301; CMS State Operations Manual (SOM), Appendix (App.) P, sec. IV. Each deficiency citation in the SOD is identified by an alpha-numeric "tag" number that corresponds to the relevant participation requirement in Part 483 of the regulations. SOM, App. P, sec. IV.

The SOD also includes the survey agency's findings about the "seriousness" of each deficiency. See 42 C.F.R. � 488.404. The seriousness of a deficiency depends on its "scope" and "severity." SOM, App. P, sec. V. "Severity" refers to whether a deficiency creates the "potential for harm," results in "actual harm," or places residents in "immediate jeopardy"; "scope" refers to whether the deficiency is "isolated," constitutes a "pattern," or is "widespread." Id.; see also 42 C.F.R. � 488.404(b)(1). The most serious deficiencies are those that place residents in "immediate jeopardy." Id.

If a survey reveals that a facility is not in "substantial compliance" with one or more participation requirements, CMS may impose a CMP or other remedy to encourage the facility to bring itself into substantial compliance promptly. 42 C.F.R. �� 488.404, 488.406, 488.408, and 488.440. A facility is not in substantial compliance if it has one or more deficiencies that create the potential for more than minimal harm. 42 C.F.R. � 488.301. "Noncompliance" means "any deficiency that causes a facility to not be in substantial compliance." Id.

CMS may impose a CMP for either the number of days the facility is not in substantial compliance (a per day CMP), or "for each instance that [the] facility is not in substantial compliance" (a per instance CMP). 42 C.F.R. � 488.430(a). If a per day CMP is imposed for noncompliance at the immediate jeopardy level, the CMP must be in the range of $3,050 to $10,000. 42 C.F.R. � 488.438(a)(i). If the noncompliance is less serious, the per day CMP must be set within the lower range of $50 to $3,000. 42 C.F.R. � 488.438(a)(ii).

A facility may not appeal CMS's decision to impose a remedy. See 42 C.F.R. � 488.403(g)(2). A facility may, however, appeal the findings of noncompliance that led to the imposition of a remedy. 42 C.F.R. �� 488.408(g)(1), 498.3(b)(13). Review by an ALJ of the amount of a CMP is limited, however. An ALJ may consider only whether the amount of the CMP is reasonable based on the factors specified in 42 C.F.R. � 488.438(f). 42 C.F.R. � 488.438(e)(3); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). A finding by CMS that a facility's noncompliance has placed residents in immediate jeopardy "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2); Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003).

II. Case Background

On June 4 and June 7, 1999, the Tennessee Department of Health (TDH) performed a complaint survey of Spring Meadows. CMS Ex. 1. The survey was performed in order to investigate an incident involving a male resident referred to as Resident 1 (or R1). TDH found, among other things, that at 1:00 a.m. on April 24, 1999, a licensed practical nurse (LPN) was called into Resident 1's room by his private sitter; the LPN "noted the resident to have blood and (2) � inch lacerations above the right eye"; the sitter stated "resident hit head on side rail"; an "interview with the LPN on duty when the incident occurred revealed that no neurological assessment was performed at any time following the head injury"; documentation for the period 9 a.m. through 11:00 a.m. on April 24 noted edema to the right eye, bruising, and that the resident was lethargic (resulting in a call to his physician who told the nurse to monitor him); and, after the family arrived and noted fever and vomiting at 11:15 a.m., the resident was transferred to the hospital where he later died. Id. TDH also found that: (1) Spring Meadows had failed to perform or document a physical or neurological assessment of Resident 1 after the incident, despite a facility policy that required the nursing staff to perform and document a neurological assessment whenever a resident sustained a "head injury"; (2) Spring Meadows had failed to investigate or report suspected abuse by Resident 1's private sitter; and (3) failure by facility nursing staff to recognize that the resident had suffered a head injury, monitor the resident's condition, and perform neurological assessments as outlined in facility policy contributed to the delay of appropriate treatment and resulted in a serious threat to the resident's health. Id.

Based on these findings, TDH cited Spring Meadows for deficiencies under tags F224, F225, and F309. CMS Ex. 1. Under tag F224, TDH determined that the facility's failure to perform a neurological assessment of Resident 1 on April 24, 1999 constituted a violation of the language in section 483.13(c) that requires a facility to "develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of residents[.]" ⁽¹⁾ Id. at 1. Next, under tag F225, TDH determined that the facility's failure to investigate or report suspected abuse of Resident 1 violated the following requirements: section 483.13(c)(2), which states that a facility must, among other things, "ensure that all alleged violations involving mistreatment, neglect, or abuse, including injuries of unknown source . . . are reported immediately to the administrator of the facility and to other officials in accordance with State law"; section 483.13(c)(3), which states that the facility "must have evidence that all alleged violations are thoroughly investigated"; and section 483.13(c)(4), which states that the "results of all investigations must be reported to the administrator . . . and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident[.]" Id. at 4-5. Finally, under tag F309, TDH cited Spring Meadows for violating section 483.25, which requires a facility to ensure that each resident receives "the necessary care and services to attain or maintain [the resident's] highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care." Id. at 6.

Based on the survey findings, CMS concluded that Spring Meadows was not in substantial compliance with Medicare participation requirements from April 24 through June 11, 1999, and that each of the deficiencies cited in the SOD had placed residents in immediate jeopardy during that period. CMS Ex. 20. Accordingly, CMS imposed a CMP of $5,000 per day for the period of noncompliance. Id.

III. The ALJ Proceedings

A hearing was held at which witnesses testified for both parties. Mary Gaynor, the surveyor who performed the June 7, 1999 complaint survey of Spring Meadows, testified on behalf of CMS. Spring Meadows presented the testimony of its administrator Shannon Ruth Jones; its Director of Nursing (DON) in April 1999, Paige Adams; and its Medical Director, Dr. David L. Gullett. Spring Meadows also presented testimony from LPN Denise Baggett, who came on duty at 7:00 a.m. on April 24, 1999, and first observed Resident 1 that morning at 9:00 a.m. Spring Meadows did not present testimony from Charleston Brown, who was the LPN on duty until 7:00 a.m. on that date, nor from other nurses who attended to the resident immediately after the incident.

The parties submitted briefs after the hearing. In its post-hearing brief, CMS contended that Spring Meadows did not comply with section 483.13(c) because the nursing staff had failed to implement its "Accident and Incident Report" policy after the incident on April 24. ⁽²⁾ CMS asserted that Resident 1 suffered a head injury on April 24, 1999, but that the facility failed to perform a neurological assessment and to document it on a "neurocheck" form, as required by its policy.

CMS also contended that a statement by a facility staff member that the sitter's story was inconsistent with the location of blood (on the door frame) observed at the time of the incident showed that Spring Meadows had reason to suspect that Resident 1 might have been abused, but Spring Meadows failed to implement its abuse investigation and reporting policy. That policy, said CMS, required the facility to collect statements about an incident of suspected abuse, notify the administrator about the incident, and forward the results of any investigation to the state survey agency within five days of the incident. CMS Post-Hearing Brief at 12-13.

Finally, regarding the deficiency citation under tag F309, CMS asserted:

The facility's failure to provide services to ensure Resident 1's quality of care, such as failure to adequately investigate possible instances of abuse and failure to recognize and provide adequate observation and treatment for a head injury, clearly compromised Resident 1's quality of care.

CMS Post-Hearing Brief at 14.

IV. The ALJ Decision

The following are pertinent findings of fact made by the ALJ concerning the April 24, 1999 incident involving Resident 1:

1. R1 was a 93 year old gentleman who had been admitted to Petitioner's facility on January 25, 1999. He suffered from several medical conditions including dementia, chronic obstructive pulmonary disease (COPD), coronary artery disease, hypertension, congestive heart failure, shortness of breath, sick sinus syndrome, gastro-esophageal reflux disease (GERD), and irritable colon. He exhibited agitated behavioral symptoms and resisted care. He was alert but confused. . . .

2. R1 appeared to be deteriorating around the time of the incident in question. Approximately one month prior to the incident, R1 experienced an agitated episode during which he worked free of his physical restraints and thrashed about, hitting, kicking, throwing furniture and breaking his dentures. On the night prior to the incident in question, the facility staff noted the resident was not feeling well and had slight rubbing sounds in his lungs.

3. As a result of R1's agitation and destruction in March 1999, his physician had recommended to R1's family that they arrange for a sitter to come to Petitioner's facility and sit with R1 at night. The family did employ a sitter and a sitter was in the room with R1 on the night of April 23-24, 1999.

4. At about 1:00 a.m. on the morning of April 24, 1999, R1's sitter summoned Petitioner's charge nurse, Charleston Brown, LPN, to R1's room. The sitter told the charge nurse that the resident had hit his head on the bed's side rail. The charge nurse observed an injury above R1's right eye; that is, R1 had two lacerations each about � inch over the right eye. The LPN applied steri strips to the wound, covered the wound with a telfa pad and an ice pack. About an hour and a half later, the sitter came out of R1's room and reported R1 was in pain and asked if R1 could be given a pain medication. The charge nurse gave R1 Tylenol, which R1 was able to swallow. The charge nurse phoned R1's daughter at 6:15 a.m. about the incident.

5. At about 7:00 a.m. another nurse, Denise Baggett, LPN, arrived to assume responsibility for the care of residents including R1. She did not immediately go to see R1. Rather she attended to some dining room activities. At 9:00 a.m. she examined R1. She noted edema with red circular bruising and purple discoloration on the outer borders approximately 5 centimeters in diameter above his right eye. She noted R1 refused to leave the bandages on and was very agitated and lethargic. The sitter informed LPN Baggett that R1 had not slept well the night before.

6. LPN Baggett then called R1's physician. R1's physician instructed LPN Baggett to monitor the resident and apply ice as needed. She noted that R1 refused ice and became agitated. She also noted that the staff had performed ADLs for R1 and R1 was resting quietly with his eyes closed.

7. Some members of R1's family came to the facility on the morning of April 24, 1999. At about 11:15 a.m., after one of R1's family members reported that R1 had a fever and had vomited, LPN Baggett again contacted R1's physician and asked that R1 be transferred to the hospital. R1 was transported to the emergency room (ER) fifteen minutes later. While R1 was being sent to the ER, LPN Baggett filled out a patient transfer form and stated that the diagnosis at the time of the transfer was "head injury/possible aspiration."

8. Neither LPN Brown nor LPN Baggett did a neurological assessment of R1 after his injury and while he was in their care.

9. At the hospital, R1 was coded as "do not resuscitate." Only comfort measures were requested by his family. Three days later R1 died. The cause of R1's death is unclear. He had several diagnoses the few days he was in the hospital including cerebral vascular accident (CVA) with intra cranial bleeding, heart attack, pneumonia and sepsis.

* * *

12. About 1� weeks after R1's death (between May 3 and 7, 1999), DON Adams was summoned to a meeting with R1's family members. The family members had a photograph of R1 showing the wound above his right eye and expressed concern that the injury did not appear to be consistent with the sitter's report that R1 had fallen backwards. Moreover, the hospital had told the family that R1 had expired due to a CVA. The family members asked the DON whether she thought it peculiar that the sitter had not called the family to inquire about the resident.

13. At the time of the family meeting, DON Adams could not identify the sitter but was told by the family that a S.W., Jr., or his father, S.W., Sr., had been the sitter for R1 on April 24, 1999. Some family members expressed their belief to DON Adams that these men were associated with a church and they did not think the sitter would have hurt R1. On the other hand, the family had some unresolved questions about the incident. At that time, the DON knew the sitter had not reported and signed in as required by facility policy. The DON suggested that the family ask Adult Protective Services (APS) of the Tennessee Department of Human Services to assist them.

14. After the conversation with R1's family, DON Adams spoke to Administrator Jones and the social services worker who had originally been told by the hospital that R1's cause of death was pneumonia. At DON Adams' request, Petitioner's social services worker phoned the hospital and reported to DON Adams that she was again told R1 had died from pneumonia.

15. Neither DON Adams nor Administrator Jones contacted the Tennessee Department of Human Services regarding the concerns expressed by R1's family.

ALJ Decision at 5-8 (citations omitted).

Based on the foregoing and other factual findings, the ALJ upheld CMS's findings of noncompliance under tags F225 and F309, but not the finding of noncompliance under tag F224. Regarding tag F224, the ALJ concluded that, although Resident 1 had suffered a "head injury" on April 24, 1999, CMS failed to establish that Spring Meadows was not in substantial compliance with the requirement in section 483.13(c) that it develop and implement policies to prohibit abuse and neglect. ALJ Decision at 9-11. She based this conclusion on her evaluation that a preponderance of the evidence showed that it was not medically necessary for the facility to have performed a neurological assessment of Resident 1, and therefore the facility's failure to perform one did not constitute "neglect." Id. The ALJ also found that CMS had "provided no credible or reliable evidence to support the various statements in its brief that Resident 1 had a deadly head injury or that the injury caused or hastened his death." Id. at 9. In addition, the ALJ found:

Although I suspect that performing neuro checks following a head injury is the better nursing practice, CMS failed to offer a preponderance of the evidence that a neurological assessment is required and standard medical practice when a resident has a head injury. Surveyor Gaynor [CMS's witness] is a registered nurse who certainly has more expertise concerning good nursing practice than the average layperson. On the other hand, DON Adams, also a registered nurse, testified that a nurse familiar with a patient can tell whether that patient has sustained a neurological injury. The nurse can see whether a resident has diminished orientation or consciousness because the nurse knows the resident's baseline. While DON Adams admitted R1 had an acute episode, she also said R1's baseline had not changed and the LPN could determine a formal neuro check was unnecessary.

Id. at 11 (citations omitted).

Regarding tag F225, the ALJ found that Spring Meadows had failed to report allegations of abuse as required by 42 C.F.R. � 483.13(c)(2) and (c)(4); failed to perform an investigation of the suspected abuse involving Resident 1, as required by 42 C.F.R. � 483.13(c)(3); and failed to implement its written policies regarding the prevention of abuse, mistreatment, and neglect, as required by 42 C.F.R. � 483.13(c). ALJ Decision at 12-20.

Finally, regarding tag F309, the ALJ found:

R1's plan of care dated February 3, 1999, reported R1's propensity to climb out of bed and over the bed rail if not restrained. Petitioner's stated goal to address this problem was to emphasize safety with no incident reports due to falling. Petitioner's stated approach in R1's plan of care for this goal was to restrain R1 with a posey vest or the side rails up and to check his restraint every 30 minutes and release R1's restraints every two hours to allow R1 to exercise.

I reviewed the evidence regarding the staff's activities that night and compared those activities with R1's sitter's actions. I can only conclude that Petitioner basically left the care of R1 in the sitter's hands. Petitioner attended to R1 when the sitter called upon the staff, first, to relate the injury, and second, to ask for pain medication for R1. LPN Brown apparently looked in on R1 at 3:30 a.m to ask whether the pain medication had worked. There is no evidence that anyone on Petitioner's staff checked on R1 between 3:30 a.m. and 9:00 a.m. R1's care was left in the hands of a person whom the Petitioner did not know and about whose duties Petitioner was unaware.

Petitioner's plan of care contemplated the need for some substantial monitoring of R1, certainly more frequently than the times recorded in the nurses' notes. An abdication of staff monitoring because R1 had a sitter with him is a failure to provide necessary services according to R1's plan of care, particularly when the facility is unaware of the identity or duties of the sitter. Based on the plain language of [section 483.25], Petitioner was not providing the necessary care and services to attain or maintain R1's highest practicable physical well-being.

ALJ Decision at 21 (citations omitted; emphasis added).

After concluding that the facility was not in substantial compliance with sections 483.13(c)(2)-(4) and 483.25, the ALJ upheld, as not clearly erroneous, CMS's determination that the deficiencies had placed residents in immediate jeopardy. ALJ Decision at 22-23. The ALJ further concluded that Spring Meadows was in noncompliance -- at the level of immediate jeopardy -- through June 7, 1999 (not June 11, as CMS had found). Id. at 23-24. Finally, the ALJ determined that the amount of the CMP imposed by CMS was unreasonable and accordingly reduced it from $5,000 to $3,150 per day. Id. at 24-25.

Spring Meadows subsequently filed a request for reconsideration, challenging the ALJ's conclusion that the facility was not in substantial compliance with section 483.25 (tag F309). As indicated, the ALJ based that conclusion on her finding that Spring Meadows had failed to perform periodic safety monitoring of Resident 1, as called for in the plan of care, between 3:30 a.m. and 9:00 a.m. on April 24 and essentially left him in the hands of the sitter during that time. Spring Meadows contended that its alleged failure to perform such monitoring was not a basis for the survey agency's deficiency finding under tag F309. As a result, said Spring Meadows, it lacked notice that a finding of noncompliance might be made or sustained on that basis and was therefore deprived of an opportunity to demonstrate at the hearing that Resident 1 had in fact been adequately monitored on April 24. ⁽³⁾

In response to the motion for reconsideration, the ALJ issued an Amended Decision that modified her original decision in only one significant respect -- namely, by reducing the CMP from $3,150 to $3,050 per day. Spring Meadows Health Care Center, DAB CR1130 (2004). The ALJ declined to amend her findings regarding tag F309, stating that Spring Meadows' "newly-submitted evidence did not persuade her to change the Decision." Id. at 5.

Spring Meadows then appealed the ALJ Decision (as amended) by filing a request for review with the Board. On August 11, 2004, while the appeal was pending, the Board sent the parties a letter with questions on various issues. Both parties filed written responses to the letter.

V. Standard of Review

The standard for our review of an ALJ decision on a disputed issue of law is whether the ALJ decision is erroneous. Our standard of 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. Guidelines - Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs (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 (10th Cir. 2000).

VI. Discussion

As a preliminary matter, we note that the ALJ's conclusions regarding substantial compliance under tags F224 and tag F225 are not at issue in this appeal. Accordingly, we do not review those conclusions, and our decision is not precedential in that regard.

The issues Spring Meadows raises in its appeal relate to: (A) the ALJ's findings and conclusion concerning the deficiency reported under tag F309; (B) CMS's immediate jeopardy determination; (C) the ALJ's finding regarding the duration of the immediate jeopardy; and (D) the reasonableness of the amount of the CMP. We address these issues in sections A through D below.

A. Spring Meadows was not in substantial compliance with the participation requirement in section 483.25.

1. In concluding that Spring Meadows was not in substantial compliance with section 483.25, the ALJ improperly relied on a factual basis for which Spring Meadows did not have adequate notice; this procedural error was not prejudicial since the record supports the ALJ's conclusion, based on grounds alleged by CMS of which Spring Meadows did have adequate notice.

Renewing the objection raised in its request for reconsideration, Spring Meadows asserts in its request for review that the ALJ's finding of noncompliance with respect to tag F309 must be set aside because the factual basis for that finding was not disclosed or identified by CMS or the ALJ prior to or during the hearing. Request for Review (RR) at 9-17. We find merit in this due process contention.

The ALJ found that Spring Meadows failed to carry out instructions in the plan of care to monitor Resident 1 periodically in order to check and, when necessary, release his physical restraints and to otherwise ensure his physical safety. The problem with this finding is that Spring Meadows had no notice, in the SOD or in CMS's pre-hearing submissions, that the failure to perform periodic safety inspections might be the basis for finding noncompliance under tag F309. Although the SOD does refer to a failure to monitor the resident, the SOD as a whole makes it clear that the survey agency was relying on Spring Meadows' alleged failure to recognize Resident 1's head injury, to perform a physical and neurological assessment, and to monitor Resident 1 for any effects of the head injury, as a basis for citing tag F309. ⁽⁴⁾ CMS urged the ALJ to sustain the tag F309 citation on that basis, but did not rely on any lack of monitoring of the resident's restraint, pursuant to the plan of care. Moreover, neither CMS nor the ALJ questioned the facility's witnesses about the safety monitoring given to Resident 1, and CMS proffered no evidence on that subject in its case-in-chief.

CMS's response brief on appeal studiously ignores the thrust of Spring Meadows' due process argument. CMS asserts that a deficiency was correctly cited by the survey agency under tag F309 "because the facility staff failed to properly assess Resident 1's injury as a head injury and provide appropriate treatment . . . ." Response Brief at 3. CMS also asserts that the "SOD was quite clear in setting out the factual allegations underlying Tag 309 as it related to Spring Meadows failure to maintain Resident 1's well being by failing to provide a timely assessment of his condition, thus delaying appropriate medical treatment and resulting in serious harm to the resident." Id. (emphasis added). However, the "assessment" that CMS refers to here is not the periodic safety assessment called for by the plan of care, but the neurological and physical assessment that was, in CMS's view, necessitated by Resident 1's head injury.

In short, CMS has not explained why Spring Meadows should be deemed to have had pre-hearing notice that compliance with Resident 1's plan of care for safety monitoring was at issue in this case. Because Spring Meadows did not have timely notice of this issue, Spring Meadows had no effective opportunity to present testimony and other evidence to show that Resident 1 received the safety monitoring called for in the plan of care. ⁽⁵⁾ The Part 498 regulations contemplate that notice of the issues will be given prior to the hearing. 42 C.F.R. �� 498.52, 498.56. Consequently, the findings on which the ALJ based her conclusion regarding section 483.25 must be set aside. Livingston Care Center, DAB No. 1871 (2003) (due process requires adequate notice of the issues in controversy and a meaningful opportunity to be heard).

Setting aside the ALJ's findings because of the procedural error does not necessarily mean that we must set aside her conclusion that Spring Meadows was not in substantial compliance with section 483.25, however. When the Board finds a procedural error, the Board will reverse or remand only if the procedural error was prejudicial. See Guidelines -- Appellate Review of Decisions of Administrative Law Judges Affecting a Provider's Participation in the Medicare and Medicaid Programs; Livingston Care Center. Here, CMS relied on grounds for finding noncompliance under tag F309, about which Spring Meadows had adequate notice -- namely the failure to identify Resident 1's head injury, to perform neurological and physical assessments of Resident 1, and to monitor his condition for potential effects of the injury. Since the record is fully developed on these grounds, we have determined in the interest of judicial economy to address them here, rather than remanding the case to the ALJ. ⁽⁶⁾

As discussed next, based on our review of the record, we conclude that Spring Meadows did not meet its burden to show, by a preponderance of the evidence, that it was in substantial compliance with section 483.25. Before discussing the factual issues, however, we first address Spring Meadows' legal arguments that the language in section 483.25 on which CMS relies is unconstitutionally vague, and that CMS's reliance on the neurocheck policy is improper since section 483.25 does not require Spring Meadows to have such a policy.

2. Section 483.25 is not unconstitutionally vague, and the lack of a specific requirement in that section for a "neurocheck" policy does not mean that the policy is irrelevant in evaluating compliance with the section.

Section 483.25 addresses quality of care. The lead-in language on which CMS relies states:

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.

The subsections of section 483.25 address particular types of needs with more specificity.

Spring Meadows argued that CMS could not properly rely on the lead-in language because it was unconstitutionally vague and because it does not specifically require Spring Meadows to have a "neurocheck" policy. ⁽⁷⁾

We disagree. The lead-in language is based on the statutory definition of skilled nursing facility services in section 1819(b) of the Social Security Act. The statute and the regulations as a whole are based on the premise that the facility has (or can contract for) the expertise to first assess what each resident's needs are (in order to attain or maintain the resident's highest practicable functional level) and then to plan for and provide care and services to meet the goal. The wording was chosen to reflect an approach that emphasizes resident care outcomes, rather than procedural and structural requirements. See, e.g., 54 Fed. Reg. 5316, 5332 (Feb. 2, 1989). In the preamble to implementing regulations, CMS stated:

We recognize that a facility cannot ensure that the treatment and services will result in a positive outcome since outcomes can depend on many factors, including a resident's cooperation (i.e., the right to refuse treatment), and disease processes. However, we believe it is reasonable to require the facility to ensure that "treatment and services" are provided, since the basic purpose for residents being in the facility is for "treatment and services" and that is why the Medicare or Medicaid program makes payment on the residents' behalf. We also think it is reasonable to require the facility to ensure that the resident does not deteriorate within the confines of a resident's right to refuse treatment and within the confines of recognized pathology and the normal aging process.

Id. The preamble goes on to say that the facility could "direct surveyor attention to any evidence (the resident [sic] or the resident's clinical record) in order to show that a negative resident care outcome was unavoidable." Id.

While the clearest case of failure to meet the general requirement is failure to provide one of the specific services outlined in the subsections or failure otherwise to follow the plan of care based on the comprehensive resident assessment, the regulation, in context, is clear enough to support applying it in other circumstances. Thus, we have upheld ALJ decisions that impose remedies based on this section where the care provided did not meet "professional standards of quality," since the regulations elsewhere require that the services provided or arranged by the facility must meet such standards. 42 C.F.R. �� 483.25, 483.75. Indeed, Spring Meadows effectively concedes in its arguments that failure to meet such standards would be a basis for finding noncompliance with section 483.25. Given the wording of section 483.25, meeting professional standards of quality may not always be sufficient, but at the very least, such standards define the minimum services that must be provided, and Spring Meadows cannot reasonably claim that it did not know it had to meet such standards.

Moreover, contrary to what Spring Meadows argued, it was not improper of CMS to rely on Spring Meadows' own policy in evaluating its compliance with the quality of care requirement, even though section 483.25 does not specifically require that Spring Meadows have such a policy. The regulatory approach gives facilities flexibility in the structure and procedures used to ensure that residents receive the described services. Thus, it was reasonable for CMS to rely on the facility's policy as evidencing the facility's evaluation of what must be done to assess a resident's head injury in order to meet the quality of care requirement, even if the facility was not required to adopt a written policy to meet the requirement. ⁽⁸⁾ Alternatively, as we discuss below, it is reasonable to presume that the facility's policy reflects professional standards of quality, absent convincing evidence to the contrary. ⁽⁹⁾

Consistent with the outcome-oriented regulatory approach, moreover, the facility has an opportunity to show that any negative care outcome for a particular resident does not evidence a failure to provide quality care consistent with section 483.25 because the resident's decline was unavoidable, given the resident's condition or refusal of treatment. Where the circumstances of an incident evidence a more systemic problem, however, CMS is not required to ignore the systemic failure merely because it may not in fact have resulted in harm for the particular resident or residents involved. See St. Catherine's Care Center of Findlay, Inc., DAB No. 1964, at 11 (2005) (and cases cited therein). This is clear from the fact that noncompliance may be found even if there is only the potential for more than minimal harm, but no actual harm. In that sense, the outcome being looked at is the quality of care being provided, not just the health outcome for the individual resident.

We also note that, in circumstances where a resident is injured or otherwise has a change in condition, merely following the resident's plan of care is not sufficient to meet the quality of care requirement in section 483.25 since any resulting resident need would not have been previously assessed and addressed in the plan of care. Moreover, a facility is required under the regulations to notify a resident's physician if any injury "has the potential for requiring physician intervention," and to notify the physician and/or take other steps if there is a significant change in a resident's condition. 42 C.F.R. �� 483.10(b)(11); 483.20(b)(2)(ii). Implicit in these requirements is the need to assess the nature of an injury and any effects on the resident's condition.

Finally, we reject Spring Meadows' argument that only the subsections of section 483.25 are sufficiently specific, so the "catchall" lead-in language should not be cited as a basis for finding noncompliance. CMS's guidance on section 483.25 in its State Operations Manual (SOM) has long treated the lead-in language as a requirement that could be cited even if the more specific requirements in the subsections were met, thus recognizing that limiting application of the section to those narrow instances would not meet congressional intent regarding facility quality of care. The SOM guidance under the separate tag number (F309) assigned to the lead-in language recognizes that some assessments of a resident's needs, in addition to the comprehensive assessment, may need to be performed in order to meet the statutory and regulatory goal. SOM, App. P, Part II (Guidance to Surveyors -- Long-Term Care Facilities).

3. Spring Meadows' "neurocheck" policy is a policy relevant to the quality of care standard in section 483.25.

At the time the incidents in question occurred, Spring Meadows had a policy, called the "Accident and Incident Report" policy, that required the nursing staff to complete a neurological assessment form whenever a resident suffered a "head injury." CMS Ex. 12. The assessment form, called a "neuro-check assessment record," solicits information every two hours (for a period of 72 hours) and has the following categories: "Vital Signs," "Consciousness Normal for Resident," "Verbal Response Normal for Resident," "Responds to: Verbal Stimuli, Light Touch, Painful Stimuli," "Pupils Both Equal Normal & react to light," Grip "WNL for pt" (for both right and left hand), moves "extremities Normal for pt." (for both right and left extremities), and "No seizure activity." CMS Ex. 15, at 2; CMS Ex. 16, at 2. ⁽¹⁰⁾ Spring Meadows also had an "Acute Episode" policy that required documentation in the medical record each shift for any acute episode or change in condition, including documentation of "neuro checks if head injury or CVA is suspected for at least 72 hours, or longer until the condition is stable or the resident is transferred to an acute care facility." CMS Ex. 13.

When a facility adopts a policy that calls on the nursing staff to take affirmative actions to safeguard resident health and safety, it is reasonable to infer (in the absence of evidence to the contrary) that the facility did so because such actions are necessary to attain or maintain resident well-being. The policy here is clearly designed to address resident well-being by ensuring full, timely, and regular assessment of whether an injury to the head has caused a decline in the resident's status that needs to be addressed through medical treatment or other services. The policy's documentation requirements also serve to enhance resident well-being by ensuring that all caregivers have the information necessary to make timely, post-injury decisions to identify and meet the resident's needs.

While the surveyor testified that she would not find a facility out of compliance with section 483.25 on the basis that it did not have a written "neurocheck" policy like Spring Meadows' policy, Spring Meadows' reliance on this testimony is misplaced. Section 483.25 gives facilities flexibility about how to meet the regulatory goal, but that does not mean that CMS needs to ignore a facility's failure to meet the policies it has adopted to meet that goal, where the policy is fairly read as representing the facility's judgment about what services are needed in particular circumstances. The surveyor clearly and reasonably viewed the policy as a "requirement for the health and safety" of facility residents. Tr. at 95.

4. The policy applied to Resident 1's injury.

DON Adams admitted that the incident in which Resident 1 was injured constituted an acute episode, within the meaning of Spring Meadows' policy. Tr. at 178. Further, Spring Meadows does not deny that Resident 1 suffered a head injury but asserts that the injury "was not a head injury that required a neurological assessment (or neurocheck)." Petitioner's Response to Questions at 1 (emphasis in original). According to Spring Meadows, it "did not consider the small lacerations on the resident's forehead to be the type [of] head injury that required either a neurocheck or neurological assessment." Id. (emphasis in original). Spring Meadows relies on testimony by DON Adams that the neurocheck policy was not intended to apply to all head injuries, only to head injuries that, in a nurse's professional judgment, were ones "where you would expect neurological changes." Tr. at 158. ⁽¹¹⁾ Spring Meadows also says its testimony "supports the proposition that after a head injury of the type suffered by Resident 1 no neurological assessment was required." Petitioner's Response to Questions at 4 (emphasis in original).

We do not find these arguments persuasive. First, neither the "Accident and Incident" policy nor the "Acute Episode" policy makes any distinction between types of head injuries. Nor does either policy document contain any statement indicating that nurses are free to exercise their judgment about whether to do neurochecks when there is a head injury or suspected head injury. CMS Exs. 12, 13.

Second, even assuming that the policy permitted an exercise of nursing judgment about the nature of the head injury, there is nothing in the contemporaneous nurse's notes or incident report to support a finding that any of the facility nurses who attended to Resident 1 after the incident had in fact exercised nursing judgment and determined that Resident 1's injury did not require a neurological assessment, nor did any of those nurses testify to that effect. ⁽¹²⁾ Moreover, the nurse's notes from the time of the incident indicate that the LPN was summoned to the resident's room by his sitter, that the sitter stated that Resident 1 had "hit his head" on the side rail of the bed, and that the nurses noted blood over the eyes and "lac. 2 � inch" above the right eye. CMS Ex. 4, at 20. Since the nurses did not observe the incident, it is difficult to see how they could determine, without further assessment over a period of time, that the resident had not hit his forehead with sufficient force to cause neurological change.

Third, the ALJ made a finding -- and there is substantial evidence to support it -- that Resident 1 suffered a "head injury" in the early morning hours of April 24, 1999. In doing so, she rejected Spring Meadows' argument that the injury was not the type of injury requiring neurological assessment. Specifically, the ALJ found:

The greater weight of the evidence is that R1 did, in fact, suffer a "head injury." While Petitioner attempted to portray R1's injury as minor skin tears or small lacerations, R1's injury was more extensive. As part of LPN Baggett's transfer of R1 to the hospital, she referred to R1's diagnosis as a head injury. She explained a few days later to Administrator Jones that R1 had been bleeding badly under the skin. Further, R1's hospitalization notes refer to R1's "large laceration and contusion on the right forehead with bruising @ the eye" and "head trauma to the rt side." CMS Ex. 18, at 18, 23, 32. A hospital physician also makes a reference to a laceration with three sutures and "6 days to get stitches out." CMS Ex. 22, at 36. These references strongly suggest to me that R1's injury was far more serious than minor skin tears.

ALJ Decision (July 9, 2003), at 9. ⁽¹³⁾

Spring Meadows points to the notation in the incident report that the resident was "alert" as somehow supporting its position regarding the type of head injury Resident 1 had suffered. While it may mean that there was no immediate effect on his level of consciousness, the notation also suggests that LPN Charleston Brown, the nurse who completed the report after the incident (and did not testify), thought that alertness (which Spring Meadows' witnesses testified was the most important component of a neurocheck) was relevant in evaluating the injury. Thus, this notation undercuts any suggestion that the nurses who observed the resident at the time thought that the injury was merely a minor skin tear that did not require any neurological assessment. ⁽¹⁴⁾

We therefore find that Spring Meadows' policy that a neurocheck be performed and documented applied to Resident 1. The surveyors found, and Spring Meadows does not dispute, that the nursing staff did not complete a neurocheck form or otherwise document a neurological assessment of Resident 1 in accordance with the facility policy.

5. Testimony that "neurochecks" were not medically necessary for Resident 1 is irrelevant and not persuasive.

We also conclude that Spring Meadows' reliance on testimony to the effect that neurochecks were not "medically necessary" for the type of injury Resident 1 suffered to be misplaced, for several reasons. First, Spring Meadows pointed to nothing to support the conclusion that section 483.25 requires only services that are "medically necessary." In response to Board questions, Spring Meadows acknowledged that "medically necessary" is only "one of the ways of interpreting the word 'necessary'" in section 483.25. Petitioner's Response to Questions at 3. In our view, interpreting section 483.25 to require only "medically necessary" services is not reasonable. Section 483.25 instead requires that each resident must receive care and services necessary to attain or maintain a resident's highest practicable well-being. ⁽¹⁵⁾ Services that a nursing facility undertakes to provide to meet the statutory and regulatory goal may not all be medically necessary, as that concept is generally understood, and the specific subsections refer to some services that are preventive in nature. Here, the issue is whether a facility's failure to identify an injury as a "head injury" requiring neurological assessment, and to provide neurological assessments and monitoring of the resident's condition, evidences noncompliance because such failures could cause a delay in providing medical diagnosis and treatment or other nursing services in order to maintain the resident's highest practicable well-being.

Second, the testimony by Spring Meadows' witnesses regarding "medical necessity" was based on their review of some of the records regarding Resident 1, in the context of giving their opinions on whether failure to do the neurochecks was neglect that caused Resident 1's death. A thorough reading of the testimony of DON Adams, moreover, indicates that it was carefully crafted to state what her evaluation of the need for a neurological assessment was after her initial review of the incident report and nurse's notes, at which time she had determined that the injury was only "minor skin tears." Tr. at 155-162. She did not testify that her evaluation would be the same based on the more complete information she had after she had talked with the nurses involved and had done a more thorough investigation. Similarly, Dr. Gullet concluded that the injury was not a "significant" one for which neurochecks would be medically necessary based on his understanding of the incident, including an assumption that the resident was "in bed" at the time he hit his head on the side rail. Tr. at 216; see also Tr. at 225 and compare Tr. at 233. The nurse's notes merely note "hit head on side rail," without stating from what position, however, and that was based on the sitter's report, not on personal observation.

Moreover, since Spring Meadows failed to do and document the neurochecks or to do any contemporaneous investigation of the incident, its witnesses' evaluation of the type of injury and the role the injury may have played in Resident 1's deterioration is based on incomplete information. Similarly, in light of the sparse information in the nurse's notes, we simply do not know whether performance of neurochecks, consistent with Spring Meadows' policy, would have yielded signs or symptoms of a change in Resident 1's neurological status before 9:00 a.m., or between 9:00 and 11:15 a.m., that might, in turn, have led to quicker intervention that might have made a difference in his well-being.

6. The circumstances indicate noncompliance with section 483.25 because they evidence a systemic failure that could affect other residents, and, in any event, Spring Meadows' evidence regarding why it did not provide the services to Resident 1 is seriously flawed.

Spring Meadows' case focused on Resident 1, and the argument that neurochecks would not have been useful for him and that any delay in transferring him to the hospital did not matter because he died of pneumonia.

As noted above, however, an incident regarding a resident may evidence a systemic failure that can be a basis for a finding of noncompliance (triggering the need for remedies to ensure corrective action), even if a causal relationship is not shown between the failure and actual harm to the resident. Here, regardless of the effect of Spring Meadows' failure on Resident 1, nursing staff failure to recognize that a head injury had occurred and to follow its policy raises a substantial question about the quality of care Spring Meadows was providing.

There is ample evidence in the record to support a conclusion that such failures could result in failure to recognize a deterioration in the resident's status, a failure to timely provide needed services, and serious consequences. ⁽¹⁶⁾ For example, Surveyor Gaynor described the purpose of the neurocheck form for a resident with a head injury, by explaining that "if there's any variation from normal in any of those areas, it can indicate that you have some deterioration [in neurological status] from the normal." Tr. at 40-41. Moreover, when she testified about the facility's requirements in its neurocheck policy, she testified that they were consistent with her nursing training concerning neurological assessments and that they all were "pretty standard" and "very important." Tr. at 68-69.

Spring Meadows presented testimony that the "most important" change to look for is a change in mental status (or alertness), but did not rebut the testimony that the other tests were very important. Nor did DON Adams explain why she would have drafted a policy that required nursing staff to do and document regular and comprehensive neurochecks for head injuries if this was not generally necessary.

In any event, we do not think that Spring Meadows' evidence regarding Resident 1's particular circumstances excuses its failure to follow its own policy in caring for him after the injury. In addition to its argument that the injury was not the type of head injury covered by the policy (which we rejected above), Spring Meadows presented testimony that, given Resident 1's combativeness and other circumstances, some of the components of the neurocheck could not have been performed on him or would have yielded no useful information. The testimony focused on the resident's inability to grasp and on evidence that Resident 1's pupils were of unequal size in 1993 due to cataract surgery -- a condition that Dr. Gullet said he would "expect to be a persistent situation." Tr. at 217.

We first note that the neurocheck form does not ask whether the resident's status deviates from a general norm, but whether it deviates from what is normal for the resident. Thus, the fact that the "normal" for Resident 1 may have been that he had unequal pupils and could not grip well does not mean that the nurses could not have noted whether he had some neurological deterioration from the normal in those areas, as well as the other areas on the neurocheck form. With respect to the testimony about the unequal pupils, it is not based on any personal knowledge about whether the pupils in fact continued to be unequal years after the cataract surgery and is undercut by a hospital record indicating that Resident 1's pupils were equal (though "sluggishly reacting" to light) when he was admitted to the hospital. CMS Ex. 18, at 18; see also, CMS Ex. 18, at 11 (RN Grammer's after-the-fact statement that his "pupils were equal" immediately after the incident); CMS Ex. 18, at 41 (LPN Brown's after-the-fact statement that "pupils were equal" at 6:45 a.m.). The neurocheck form, moreover, asks for a check of whether "Pupils Both Equal Normal & react to light" and therefore is not limited to examining whether the pupils were equal. ⁽¹⁷⁾ Spring Meadows presented no specific testimony on why it could not have tested Resident 1 for reactivity to light, as the hospital did, or why that test would not have been useful.

The general testimony by Dr. Gullett that the resident's combativeness would have precluded doing any of the neurochecks (other than tests for alertness) in a useful way is also not persuasive, given contradictory evidence. For example, the record indicates that the resident's vital signs were taken after the incident, that he was placed in restraints to address his combativeness, and that LPN Baggett took his vital signs again at 9:00 a.m. ⁽¹⁸⁾ Ultimately, the rise in his temperature was one of the symptoms that led to his transfer to the hospital. Also, one of the neurochecks is to note whether there is any seizure activity. We do not see how the resident's combativeness could have prevented the nurses from observing and noting such activity, and Spring Meadows' witnesses did not address this neurocheck specifically, nor even seem to recognize it as one of the neurochecks. Similarly, the testimony does not specifically address why the nurses could not have noted whether the resident could move his extremities in a way that was normal for him, nor explain why that neurocheck would not have been useful. (The hospital record indicates that a CT scan was ordered because he exhibited a weakness on his left side. CMS Exhibit 18, at 17-23, 32. Spring Meadows did not claim this was a pre-existing problem, and the hospital record relates this to the acute hemorrhaging on the right side of his brain shown by the CT scan, which had not shown up on a CT scan done a few months earlier. Id.)

Moreover, as Spring Meadows itself points out, the incident report by the attending nurse noted that the resident was alert - an observation that goes to the resident's level of consciousness and which Spring Meadows' witnesses identified as the most important test. The fact that the nurses could make the observation at the time of the incident, and note around 9:00 a.m. that he was lethargic, undercuts any testimony to the effect that it would not have been feasible or useful for the nursing staff to observe and document Resident 1's consciousness level every two hours, as required by the policy.

Finally, in response to a question from the ALJ, Dr. Gullett testified that if a nurse noted that a patient was lethargic, neurochecks should be done at that point. Tr. at 225. Yet, while the contemporaneous nurse's notes indicate that LPN Baggett observed that the patient was lethargic (possibly as early as 9:00 a.m.), she did not comply with the neurocheck policy at that time or after talking to the attending physician (in spite of his direction to "monitor" the resident). CMS Ex. 4, at 20. ⁽¹⁹⁾ While she later testified as to why the resident's confusion, uncooperativeness, inability to cooperate, and unequal pupils would have prevented her doing some tests, she did not testify that she had in fact made any attempt to do any of these tests, nor did she explain why she could not have done or documented other neurochecks. Tr. at 233-234, 237-238.

Finally, while we agree with the ALJ that CMS did not establish that the head injury caused the acute intercerebral hemorrhaging noted on Resident 1's CT scan done upon his hospitalization, that the hemorrhaging caused his death, or that the outcome would have been different for him had he been hospitalized sooner, we also note that the evidence as a whole does not rule out the head injury as a possible cause of the hemorrhaging, nor rule out the possibility that regular and complete neurochecks might have led to his being hospitalized sooner, where medical decisions could be made about whether to treat him or not.

In sum, we conclude that Spring Meadows' failures evidence a systemic problem, regardless of the effect on Resident 1, and that, in any event, the evidence does not persuasively show that doing and documenting regular neurochecks would not have been useful for Resident 1.

7. CMS presented evidence sufficient to show that Spring Meadows' care of Resident 1 did not meet professional standards of care, and Spring Meadows did not show, by a preponderance of the evidence, that the services it provided met professional standards.

Before us, Spring Meadows argues that its position is supported by the statement in the ALJ Decision that "CMS failed to offer a preponderance of the evidence that a neurological assessment is required and standard medical practice when a resident has a head injury." Spring Meadows Reply Brief at 2. This reliance is misplaced, for the following reasons.

First, the ALJ's conclusion was made with respect to the issue of whether Spring Meadows was complying with section 483.13 and in support of the ALJ's conclusion that the facility's neurocheck policy was not a policy to prevent neglect. While we do not disturb her ultimate conclusion on that issue (since CMS did not timely take exception to the conclusion), this does not necessarily mean that our evaluation of the evidence regarding section 483.25 must be limited by her evaluation regarding section 483.13.

The ALJ's reference to "preponderance of the evidence" indicates that she applied an erroneous standard of proof, placing the ultimate burden of persuasion on CMS, rather than on Spring Meadows. Under Board precedent, Spring Meadows had the ultimate burden of persuasion to prove substantial compliance by a preponderance of the evidence (although Spring Meadows could also prevail without submitting any evidence if CMS did not make a prima facie case through undisputed facts and evidence legally sufficient to show noncompliance). Batavia Convalescent Center, DAB No. 1904 (2004). Contrary to what Spring Meadows argues, moreover, CMS did present sufficient evidence to show that Spring Meadows' care of Resident 1 did not meet professional standards of quality.

The ALJ agreed with Spring Meadows that the testimony of Surveyor Gaynor on cross-examination indicated merely that she thought that, "if a facility had any type of written policy, the facility had to follow that policy." ALJ Decision at 11. ⁽²⁰⁾ The testimony read as a whole, however, indicates that Surveyor Gaynor considered Spring Meadows' "neurocheck" policy as setting an accepted standard of practice for the facility, even if she would not necessarily cite another facility for noncompliance if it did not have such a written policy. See, e.g., Tr. at 79, referring to tag 281 (which relates to the requirement at 42 C.F.R. � 483.20(k) that the services provided by the facility must meet "professional standards of quality"). Moreover, as noted above, she testified that the facility's requirements in its neurocheck policy were consistent with her nursing training concerning neurological assessments and that they all were "pretty standard" and "very important." Tr. at 68-69.

In our view, Survey Gaynor's testimony, together with the undisputed facts that Spring Meadows had adopted the neurocheck policy but did not follow it, was sufficient to shift the burden to Spring Meadows to show that what it did do was consistent with professional standards of quality. Yet, the testimony by Spring Meadows' witnesses does not rebut the surveyor's testimony to the effect that the neurocheck policy should be considered as establishing the accepted standard of quality of care for the facility. More important, there was no testimony from any of Spring Meadows' witnesses that what it did to monitor and assess Resident 1 for any consequences of the head injury in fact met professional standards of quality for nursing care.

DON Adams testified instead that, "based on her review of the records," she saw "no problem at all with the care and evaluation and treatment and monitoring of the patient" based on "the fact that the patient had a minor - apparently a minor injury at the time and they did go back in and check on him two or three times and that he did not seem to be less alert from that time on through the night." Tr. at 161. In other words, her opinion assumed, as she had previously testified that she had determined based on her record review, that the nurses on duty had evaluated the injury as minor skin tears not needing a neurological assessment. Thus, her opinion at most goes to the standard of care when the attending nurse considers the injury to be only a skin tear and not the type of head injury that might cause a neurological change, a premise that Spring Meadows did not establish here.

Moreover, DON Adams' testimony indicates a lack of a careful review of the record. She testified that, from "reading the documentation," it was her "understanding that when the day shift nurse came in at 7:00, she called the doctor because the resident had developed a fever during that shift and the physician told her to monitor the patient." Tr. at 161. In fact, the nurse's notes indicate (and LPN Baggett admitted) that the earliest she had observed the resident was 9:00 a.m. The nurse's notes also indicate that she had observed edema and bruising to his right eye and his lethargy before calling the doctor, that at 11:15 a.m. the resident's family "stated he vomited and has fever," and that at that time the resident's temperature was 99.8 (compared to 98.7 noted in the margin for the 9:00 through 11:00 a.m. period). CMS Ex. 4, at 20. ⁽²¹⁾ We also note that DON Adams was not an independent expert. She was the DON of the facility at the time of the incident, and her actions in investigating the incident had been called into question by the survey.

Thus, we conclude that Spring Meadows did not establish by the preponderance of the reliable, probative evidence that what Spring Meadows did following the incident met professional standards of quality.

8. What Spring Meadows did fell far short of what its policy required.

The services that Spring Meadows did provide fell far short of what its policy called for. As noted above, Spring Meadows' neurocheck form solicits information every two hours (for a period of 72 hours) and has the following categories: "Vital Signs," "Consciousness Normal for Resident," "Verbal Response Normal for Resident," "Responds to: Verbal Stimuli, Light Touch, Painful Stimuli," "Pupils Both Equal Normal & react to light," Grip "WNL for pt" (for both right and left hand), moves "extremities Normal for pt." (for both right and left extremities), and "No seizure activity." CMS Ex. 15, at 2; CMS Ex. 16, at 2.

What the contemporaneous records show regarding Resident 1's care following the head injury is strikingly different. The nurse's notes contain no indication of any neurological assessment at the time of the incident (although the incident report does appear to indicate that the attending nurse, LPN Brown, noted that the resident was alert after the incident and had taken his vital signs). The nurse's notes indicate that at 2:30 a.m. LPN Brown was called in by the sitter because the resident was complaining of pain. LPN Brown gave the resident Tylenol which he swallowed (which DON Adams said indicated that his level of consciousness was normal at the time), and at 3:30 a.m. LPN Brown checked to see whether the Tylenol had worked and noted "some relief." CMS Ex. 4, at 20. Even assuming that LPN Brown observed the resident for any change in his level of consciousness on these occasions, there is no documentation that he even attempted any of the other neurochecks or that he had attempted them and the resident was uncooperative. The next notation, at 6:15 a.m., merely indicates that the resident's family was contacted about the incident. Id.

A form for recording vital signs contains no record of Resident 1's temperature for the date of the incident, and the other vital signs are recorded only once, with the same values as what was recorded upon the resident's transfer to the hospital. CMS Ex. 18, at 70, 87. Thus, while it appears that the vital signs on the incident report were taken at the time of the incident, there is no evidence that the vital signs were taken again until at least 9:00 a.m., when LPN Baggett saw the resident for the first time that day (after coming in at 7:00 a.m. and assisting in the dining room).

In sum, even if we assume that LPN Brown did some assessment through observation of the resident at 2:30 and 3:30 a.m., Spring Meadows did not submit any credible evidence that it did any nursing assessment of Resident 1's condition in the period between 3:30 and 9:00 a.m., a period of five and one-half hours.

We do not consider the notes signed by LPN Brown, documenting some actions between 3:30 and 6:45 a.m. (CMS Exhibit 18, at 41), to be reliable evidence, for the following reasons. Those notes were not present in the resident's record at the time of the survey but were produced to the surveyors four days later and are dated June 10, 1999. Tr. at 43; see also CMS Ex. 18, at 4. LPN Brown did not appear as a witness to verify their accuracy, nor did any other witness corroborate what the document says or implies. Moreover, LPN Brown's notes produced after the survey indicate that at 6:45 a.m. Resident 1's "pupils were equal" - a notation that is inconsistent with Spring Meadows' evidence that they were not. CMS Ex. 18, at 4. In any event, the additional notes do not show any results from an assessment (or any attempt at an assessment) between 1:00 a.m. ("respond to verbal stimuli") and the 6:45 a.m. note about the pupils. Id. We note that the initials "CB" appear for April 24 on a form for documenting restraint monitoring each shift. CMS Ex. 18, at 62. We are not willing to infer from this form that LPN Brown in fact both checked the restraint every 30 minutes and paid attention to Resident 1's neurological status each time, given his failure to document any meaningful assessment of that status, either in his contemporaneous notes or in the after-the-fact ones. ⁽²²⁾

Finally, as noted above, LPN Baggett conceded that she did not do neurochecks, even though she noted at 9:00 a.m. that the resident was "lethargic" and had evidence that the injury was more serious than minor skin tears. While she testified that she did do some assessment of the resident's status, she did not satisfactorily explain why she could not have complied with the policy. In fact, her testimony indicates that she was unaware of the policy, even though she was familiar with the neurocheck form, had received a copy of facility policies, and had received training. Tr. at 237-238.

In sum, Spring Meadows did not meet its burden to show through a preponderance of the evidence that it was in substantial compliance with section 483.25.

Accordingly, we affirm the ALJ's conclusion that Spring Meadows was not in substantial compliance with section 483.25, but modify the decision to substitute our findings and supporting analysis in place of the ALJ's analysis in section II.B.5 of her decision.

B. CMS's determination that Spring Meadows' noncompliance resulted in immediate jeopardy to residents is not clearly erroneous.

CMS determined that each of the deficiencies cited in the Statement of Deficiencies (under tags F224, F225, and F309) warranted an immediate jeopardy designation. Spring Meadows' second major contention on appeal is that the ALJ erred in upholding CMS's determination that the deficiency cited under tag F225 was serious enough to place one or more residents in immediate jeopardy. RR at 18.

We note at the outset that the ALJ did not sustain CMS's immediate jeopardy finding based on the deficiency cited under tag F225 (which relates to an alleged failure to report or investigate suspected abuse by Resident 1's sitter). Indeed, the ALJ found that CMS, through its witness, Surveyor Gaynor, had "essentially conceded that the deficiency cited at Tag F225 regarding Petitioner's failure to investigate and report allegations of abuse, standing alone, did not pose immediate jeopardy." ALJ Decision at 22-23. The ALJ's immediate jeopardy analysis focused instead on the facts and circumstances that she found to constitute noncompliance with section 483.25 (tag F309). Id. at 23. Since we have set aside the ALJ's factual findings related to that section, additional analysis regarding the immediate jeopardy issue is necessary.

For its part, CMS in its response brief makes no meaningful attempt to defend the ALJ's analysis of the immediate jeopardy issue or the validity of its immediate jeopardy determination. Response Brief at 3-4. It appears, moreover, that CMS misconstrued the facility's argument concerning immediate jeopardy as a contention that the ALJ had no basis for finding noncompliance with section 483.13(c). Id.

In view of these circumstances, we asked the parties in our August 11, 2004 order to comment on the significance of Surveyor Gaynor's apparent concession that the deficiency cited under tag F225 did not by itself warrant an immediate jeopardy finding, and to indicate whether the immediate jeopardy determination could be sustained on other grounds. Based in part on the parties' responses to our questions, we conclude that the immediate jeopardy determination made by CMS with respect to the deficiency citation under tag F225 was clearly erroneous, but that the immediate jeopardy finding under tag F309 was not clearly erroneous.

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." Thus, in the absence of evidence that the deficiency has caused serious harm to a resident, a determination of immediate jeopardy requires a showing that serious harm is likely, not merely that a risk of serious harm exists. Innsbruck Healthcare Center, DAB No. 1948 (2004). In reviewing an immediate jeopardy determination, the reviewing body must consider the facts upon which CMS relied in making the determination, as well as any evidence presented at the hearing. Id. Because the definition of "immediate jeopardy" requires that there be some causal connection between the facility's noncompliance and the existence of serious injury or a threat of injury, the nature and circumstances of the facility's noncompliance are of obvious importance to the evaluation.

The gravamen of the deficiency finding under tag F225 was the facility's failure to report and investigate suspected abuse of Resident 1 by his private sitter. CMS Ex. 1, at 4-6. The ALJ found (and the record shows) that some time between May 3 and May 7, 1999, approximately one and one-half weeks after Resident 1 died, members of Resident 1's family met with the facility's director of nursing, Paige Adams. ALJ Decision at 7; Tr. at 167-68. The ALJ found that, as a result of this meeting, DON Adams knew or had reason to know that some family members suspected that Resident 1 had been abused by his sitter, and that the facility was therefore required by Tennessee law to report these suspicions to the appropriate state agency, Tennessee Department of Health, Adult Protective Services (APS). ALJ Decision at 15. Instead of reporting the abuse herself, the ALJ found, DON Adams referred the family to APS. Id. at 7. Based on these factual findings, the ALJ determined that Spring Meadows had failed to comply with requirements in section 483.13(c) that incidents of suspected abuse be investigated and reported to the state authorities and key facility personnel. Id. at 15-20.

The ALJ's findings and conclusions regarding tag F225 are based on her assumption that Spring Meadows did not have reason to suspect abuse until after Resident 1's family spoke with Nurse Adams in May 1999 (that is, after his death). Indeed, the ALJ expressly refused to find that the facility had reason to suspect abuse, mistreatment, or neglect on April 24. She noted that CMS's evidence regarding inconsistencies between the sitter's story and what RN Sharon Grammer stated in her June 9, 1999 statement about what she had observed and had been told by CNA Nicole Watkins the night of the incident was "fraught with reliability problems" since neither of these individuals testified. ALJ Decision CR1063, at 17. Since CMS did not appeal the ALJ's finding on this issue, we consider only whether CMS had some basis for concluding that the facility's failure to investigate or report suspected abuse after the May 1999 meeting placed residents in immediate jeopardy.

We find that the determination that noncompliance with section 483.13(c) was at the immediate jeopardy level was clearly erroneous. Spring Meadows presented evidence that the sitter in question did not work at the facility after April 24, and there is no reason to believe that the facility would have allowed him to do so after the meeting between DON Adams and Resident 1's family. ⁽²³⁾ In addition, CMS did not show that the facility's handling of this particular incident reflected a fundamental or systemic misunderstanding of its obligations under section 483.13(c), or that facility employees had shown an inability to comply with reporting and investigation requirements under other circumstances. Finally, as the ALJ accurately noted, Surveyor Gaynor conceded that the noncompliance reported under tag F225 was not serious enough to warrant a finding of immediate jeopardy. ⁽²⁴⁾ Tr. at 120.

Given these circumstances, we conclude that CMS's determination that the noncompliance reported under tag F225 placed residents in immediate jeopardy was clearly erroneous.

This conclusion does not provide a basis for reducing the CMP amount, however. As we discuss next, CMS's determination of immediate jeopardy under tag F309 was not clearly erroneous. Since the ALJ already reduced the CMP to $3,050, the lowest amount that applies where immediate jeopardy is found, we do not have the authority to reduce the amount further.

Surveyor Gaynor testified that the facility's failure to recognize that Resident 1 had suffered a head injury and to do neurochecks according to its policy meant that, in her judgment, this resident "and others" were likely to suffer serious harm in the near future. Tr. at 98-101; see also Tr. at 95-96. She also testified that she reviewed a sample of the facility's records, and did not see any documentation of neurochecks regarding head injuries prior to June 4, 1999. Tr. at 54-57.

The testimony of Spring Meadows' witnesses went to whether Resident 1 suffered actual harm from the facility's failures, given his particular circumstances. Overall, however, it did not undercut Surveyor Gaynor's testimony about the importance of doing neurological assessments when there is a head injury, nor her opinion that failure to recognize when a neurological assessment is needed is likely to cause serious harm in the near future. As noted above, Spring Meadows' witnesses testified that some neurochecks were more important than others, but did not rebut her testimony that each of the neurochecks is important in identifying whether a resident's condition is deteriorating. That Resident 1's condition may have deteriorated anyway or that he may have died of causes other than the head injury is irrelevant since actual harm is not a prerequisite for an immediate jeopardy determination.

Thus, we conclude that CMS's determination regarding immediate jeopardy, while clearly erroneous with respect to tag F225, was not clearly erroneous with respect to tag F309.

C. Spring Meadows was in noncompliance from April 24 to June 7, 1999 at the immediate jeopardy level.

In section II.B.5 of her decision, the ALJ determined that the facility's noncompliance existed at the level of immediate jeopardy from April 24 to (and including) June 7, 1999. ALJ Decision at 23-24. Spring Meadows contends on appeal that its noncompliance with section 483.25 existed at the level of immediate jeopardy for only one day - April 24, 1999 - and that any immediate jeopardy ceased when Resident 1 was transported to the hospital. RR at 21.

A facility is not in substantial compliance, and therefore subject to a CMP, if it has one or more deficiencies that have a risk of causing more than minimal harm to resident health or safety. 42 C.F.R. � 488.301. As discussed, the deficiency under tag F225 posed at least the potential for more than minimal harm, and CMS's determination that the deficiency under tag F309 was at the immediate jeopardy level is not clearly erroneous. Spring Meadows does not contend that it corrected those deficiencies sooner than June 8, 1999, and its own plan of correction shows that corrective work was not completed until June 11, 1997. ⁽²⁵⁾ Consequently, we affirm the ALJ's conclusion that Spring Meadows was not in substantial compliance with one or more Medicare participation requirements from April 24 through June 7, 1999.

Spring Meadows' contentions about the duration of the immediate jeopardy imply that it was CMS's burden to show that the facility's noncompliance continued at that level in the days and weeks after the incidents giving rise to the deficiency findings. CMS was under no obligation to prove continuing noncompliance, however. Once CMS established that the facility was not in substantial compliance as of April 24, 1999, the burden was on Spring Meadows to show that it had come back into substantial compliance. Brier Oak Terrace Care Center, DAB No. 1798 (2001) ("If Brier Oak wanted to establish that it was in substantial compliance with all program requirements effective the date of its POC, Brier Oak had the responsibility to prove that at the hearing"). ⁽²⁶⁾ Similarly, Spring Meadows had the burden to show that the immediate jeopardy situation did not continue because Spring Meadows had taken appropriate corrective action to remove the immediate jeopardy. Transporting Resident 1 to the hospital did not constitute such corrective action.

Further, contrary to what Spring Meadows' arguments imply, there is no requirement that the duration of a per day penalty coincide with particular events (such as the facility's response to Resident 1's head injury on April 24) that may constitute evidence of the facility's noncompliance. Florence Park Care Center, DAB No. 1931 (2004). CMS may impose a per day CMP that begins to accrue "as early as the date the facility was first out of compliance" and remains in effect until CMS verifies, usually by conducting a revisit survey, that the facility has implemented a plan of correction that ensures that similar incidents will not recur. Florence Park Care Center; Cross Creek Health Care Center, DAB No. 1665 (1998).

D. A CMP of $ 3,050 per day for the period of noncompliance is reasonable.

Our conclusion regarding immediate jeopardy requires that we uphold the amount of the per day CMP since $3,050 per day is the lowest amount in the range that applies when immediate jeopardy is found. See 42 C.F.R. � 488.438.

Spring Meadows asserts that its noncompliance resulted in no actual harm to residents and, on that ground, urged us to impose a "minimum" per day CMP for a single day (April 24, 1999) of noncompliance or, in the alternative, a "per instance" CMP. In support of its request for a per instance CMP, Spring Meadows directs our attention to section 7510 of the State Operations Manual. Section 7510 states that CMS may select either a "per day" or "per instance" CMP when noncompliance is identified, and that "when it is difficult to accurately establish when the noncompliance began or was corrected, the selection of the per instance civil money penalty may be the most appropriate choice." SOM � 7510.

It is unclear whether the Board or an ALJ has the authority to impose a per instance CMP when CMS has previously selected a per day remedy (as it did here). We need not resolve that issue, however, because we conclude that a per day CMP is more appropriate. A per day CMP is more appropriate because it is clear that Spring Meadows did not correct its noncompliance before June 1999. See infra footnote 25. The per day CMP is effective for the duration of Spring Meadows' noncompliance -- that is, from April 24 through June 7, 1999.

Conclusion

For the reasons stated above, the Board: (1) substitutes the factual findings and legal conclusions in section VI.A. above for the findings in section IV.B.3 of the ALJ Decision; (2) modifies the basis for the conclusion (in section IV.B.4 of the ALJ Decision) that CMS's determination regarding immediate jeopardy was not clearly erroneous; (3) affirms the conclusion in section IV.B.5 of the ALJ Decision that Spring Meadows was in noncompliance at the immediate jeopardy level from April 24 to (and including) June 7, 1999; and (4) upholds the CMP amount of $3,050 per day for that period.

Donald F. Garrett

Cecilia Sparks Ford

Judith A. Ballard
Presiding Board Member

1. For purposes of section 483.13(c), "neglect" is defined as a "failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness." 42 C.F.R. � 488.301.

2. The "Accident and Incident Report" policy (CMS Ex. 12) states that "all accidents or incidents" will be documented in an "Accident Incident/Unusual Occurrence Report." The policy then sets forth four "procedures" to be followed when an accident or incident covered by the policy occurs: (1) "[E]xamine the resident and provide emergency care to the resident"; (2) "Call the resident's physician"; (3) "Follow the instructions of the physician"; and (4) "Notify the family[.]" The policy then provides instructions about documenting the incident or accident. Item (e) states: "If the resident suffered a head injury, complete the neurological assessment form."

3. In support of its reconsideration motion, Spring Meadows attached to the motion an affidavit from Paige Adams (its DON in April 1999), who stated that routine behavioral and restraint monitoring was not documented in the nursing notes because the facility "charts by exception," and that, in any event, other records show that behavioral and restraint monitoring was performed for Resident 1 on April 24, 1999. While this proffered evidence may not be persuasive to prove compliance with the plan of care for restraint monitoring, it is at least sufficient to show that timely notice and a hearing on the issue might have made a difference in the outcome on that issue.

4. The plan of correction, which CMS approved, did not address the facility's alleged failure to perform periodic safety monitoring. Instead, the plan focused on its failure to perform a neurological assessment. CMS Ex. 1, at 2-3, 7.

5. Spring Meadows presented some documentary evidence with its motion for reconsideration, but the ALJ did not discuss that evidence other than to say that she did not find it persuasive. Spring Meadows Health Care Center, DAB CR1130 (2004).

6. The Board's authority includes the authority to modify an ALJ decision, in whole or in part. 42 C.F.R. � 498.88(f). Of course, if the ALJ had made any credibility determinations based on her observation of witness demeanor, we would defer to those determinations. The ALJ made no such determinations, however. Our evaluation of the witnesses' testimony is based on whether it is relevant and probative on the issues before us and, if so, whether it conflicts with the contemporaneous documentary evidence, which we give more weight.

7. The ALJ viewed these arguments as raising constitutional issues beyond the scope of her review. We view them as going to the interpretation of the regulation and its application to the particular circumstances here.

8. We note that the requirements for administration of a facility include the general requirement that the "facility must be administered in a manner that enables it to use its resources effectively and efficiently to attain or maintain the highest practicable . . . well-being of each resident" and the more specific requirement that the medical director is responsible for implementing "resident care policies." 42 C.F.R. � 483.75. Thus, the regulations contemplate that, as part of administering the facility in a way that will be effective in meeting the quality of care goal, the facility will have such policies, even if the specific content of the policies is not specified.

9. Spring Meadows argues that holding a facility to its own policies would penalize those facilities that adopt policies setting higher standards than the professional standards of quality. Our decision does not preclude a facility from showing that its policy sets a higher standard. See Lake City Extended Care Center, DAB No. 1658 (1998). That alone, however, is not enough to show that the facility was complying substantially with the regulatory requirements. The nature of the policy, the applicable professional standard, the extent of any deviation from the policy and the standard, and the circumstances in which the deviation occurred would all be relevant in evaluating compliance.

10. Although DON Adams appeared to indicate in her testimony that this was not the version of the neurocheck form in effect at the time of the incident, Nurse Baggett identified it as the form that was in effect at the time of the incident. Tr. at 237-238. Spring Meadows did not submit any other version of the form.

11. In its briefing, Spring Meadows mischaracterized this testimony as indicating that neurochecks applied only to the type of injury that might give rise to a CVA (stroke). In fact, the testimony does not support this characterization. Instead, DON Adams referred to the purpose as looking for "neurological changes." Tr. at 158. The example given of a "head injury" where a nurse would expect no neurological change was a "paper cut across the head." Tr. at 159. She did not testify that clear standards exist for differentiating among head injuries based on their characteristics immediately after the injury occurs, nor explain how the judgment could be made even if the nurse is not sure how the injury occurred.

12. Indeed, a statement made by Sharon Grammer (a registered nurse who was on duty the night of the incident) and dated June 9, 1999, asserts that she entered the room after the incident "and immediately began an assessment" of the resident and found that his "pupils were equal, his hand grips were firm" and he "followed verbal instruction." CMS Ex. 18, at 11. The ALJ questioned the reliability of Nurse Grammer's further statement regarding what an aide told her about observations of the room that were inconsistent with what the sitter said since neither Nurse Grammer nor the aide testified. In our view, the reliability of the statement depends on its use. One might reasonably question why, if Nurse Grammer did these tests, they were not documented in the nurse's notes. On the other hand, the fact that Nurse Grammer did not (even after the survey) claim that she had determined the injury did not require neurochecks (or that she was unable to do the tests) and instead claimed to have done a few of the tests undercuts the explanation DON Adams gave of why a complete neurological assessment was not done.

13. The citation to "CMS Ex. 22 at 36" should instead be "CMS Ex. 18, at 22, 36."

14. Moreover, since the policy contemplates that all of the neurochecks be performed and documented every two hours for 72 hours, we infer that symptoms of neurological damage may not show up right away. Thus, that the resident was alert at the time the report was filled out (apparently immediately after the incident) does not suggest that there was no head injury significant enough to cause neurological change. Indeed, LPN Baggett's notes for the 9:00 to 11:00 a.m. period indicate that she thought it was relevant at the time that Resident 1 was "lethargic" and that the resident's physician needed to be informed about the injury and his status and other symptoms, even though the injury had occurred at least eight hours before. CMS Ex. 4, at 20; see also CMS Ex. 18, at 17. We do not know at what time the resident became lethargic and developed the other symptoms since there are no contemporaneous nurse's notes at all for the period between 3:30 and 9:00 a.m.

15. Similarly, Spring Meadows' view that the purpose of the general quality of care requirement in section 483.25 is simply to provide services necessary to avoid harm is unsupported and is inconsistent with the wording and history of the provision. See Petitioner's Response to Questions at 2. Like Spring Meadows' medical necessity argument, this argument was based on the concept of neglect, which the ALJ found to be relevant for determining whether Spring Meadows failed follow a policy to prevent abuse or neglect. Section 483.25, however, sets a standard for quality of care. Compliance with that standard requires more than mere avoidance of harm through neglect.

16. Indeed, Spring Meadows conceded that "there is no doubt that neurological monitoring of some residents with some injuries should be done." Petitioner's Response to Questions at 6 (emphasis in original).

17. In response to a Board question about whether Spring Meadows had presented any specific testimony about why it could not have tested for reactivity to light, Spring Meadows cited to testimony that it said showed that the "pupil dilation test is the same as the reaction to light . . . ." Petitioner's Response to Questions at 7, citing Tr. at 40. The cited page does not support that proposition, however, and Spring Meadows' witnesses' testimony about Resident 1's eyes was based solely on his alleged condition of having unequal pupils due to cataract surgery in 1993. It does not necessarily follow that a test for reactivity to light or pupil dilation would not be useful for him. DON Adams did testify that "examining his pupils" would "[p]robably not" have had any effect on a neurological assessment if he had unequal pupils from the cataract surgery. Tr. at 175. But it is not clear whether she merely meant "examining" his pupils for unequal size would probably not be useful or also meant testing them for reactivity to light would not have been useful.

18. When asked whether neurochecks would have been useful for Resident 1, Dr. Gullett testified that "[i]t would have been very hard to evaluate because of the resident's combative behavior, his inability to cooperate" and that the "only component that would have been [useful] would have been his degree of alertness." Tr. at 217. While he testified that one of the purposes of neurochecks is to determine alertness, his testimony did not specifically identify which of the tests listed on Spring Meadows' form were used to determine alertness, nor did he testify that those specific tests were done in a timely manner for Resident 1.

19. In its response to Board questions, Spring Meadows described events as though the lethargy was not noted until later and asserted that "the record is clear" that the resident was promptly transferred to the hospital after his change in mental status or baseline. Petitioner's Response to Questions at 3-4, citing Tr. at 90-91, 155-156, 219, and 231-232. The record is far from clear, however. The testimony on which Spring Meadows relies implies that the resident's status was the same as normal because the resident "did not seem to be less alert through the night" (Tr. at 219), that he was "agitated" in the period between 9:00 and 11:00 a.m. and it was normal for him to be agitated (Tr. at 90-91, 155-156), that the relevant change that caused his transfer was his fever and vomiting (Tr. at 232), and that Nurse Baggett called his doctor at 9:00 a.m. only because of the edema and bruising to his eye and reported that the resident was normal for him (Tr. at 231). The contemporaneous nurse's notes, however, contain no information at all about the resident's alertness status between 3:30 and 9:00 a.m., and the 9:00 through 11:00 a.m. notes read as follows:

Noted edema to [right] eye [with] red circular bruising to eye [with] purple outer borders approx 5cm in diameter. Resident refuses to leave bandages on. Very agitated & lethargic - Sitter informed this nurse he didn't sleep well last noct. Call placed to MD reported all events. MD stated to monitor & apply ice PRN (Resident refuses ice becomes very agitated.) ADL's performed per staff. Resident resting quietly [with] eyes closed. Will monitor.

CMS Ex. 4, at 20. Vital signs are noted in the margin at the top of this series of notes. These notes suggest that the fact that the resident was agitated was not viewed as inconsistent with stating that he was also lethargic - a condition that Dr. Gullett testified would trigger a need for the neurochecks. They also suggest that the lethargy was noted before Nurse Baggett called the doctor.

20. The ALJ used what she acknowledged was "an obviously exaggerated example" of why she did "not agree" with the testimony, stating that "CMS appears to argue that, if a facility had a written policy to give each resident a birthday party, CMS could show a facility's failure to implement a policy against neglect by a mere showing that the facility failed to provide several residents with a birthday party." ALJ Decision at 11. In other words, the ALJ's rejection of the testimony as meaningful was in the context of considering whether the "neurocheck" policy was the type of policy covered by section 483.13. Regardless of whether CMS correctly treated the "neurocheck" policy as a policy to prevent abuse and neglect, however, the policy is on its face a policy about what services the facility will provide to a resident with a head injury and how the facility will document that it has, in fact, provided those services.

21. "Edema" means "the presence of abnormally large amounts of fluid in the tissues" and is "usually applied to an accumulation of excessive fluid in the subcutaneous tissues, resulting in swelling." Leonard, Peggy C., Medical Terminology (1990), at 23.

22. Other documents which Spring Meadows belatedly submitted to show it monitored the resident relate to the care provided by nurse aides. Spring Meadows' DON testified that an LPN familiar with a resident could identify a change in neurological status through observation, but did not testify that a nurse aide would be qualified to do this.

23. The ALJ stated that "the DON felt that the facility had no responsibility" for the sitter or his actions. ALJ Decision at 19, citing Tr. at 171-172. This statement does not accurately characterize DON Adams' testimony. For example, DON Adams stated that she always wanted to know who was in the facility at all times, and that after receiving the incident report on Resident 1, she inquired about the sitter's certification and whether he was attending to any other residents. Tr. at 170-71.

24. Surveyor Gaynor explained that the noncompliance under tag F225 was "pulled up" to a higher level of seriousness by the two other deficiencies (under tags 224 and 309) cited by the surveyors. Tr. at 120.

25. On June 16, 1999, Spring Meadows submitted a plan of correction that specified the actions it would take -- or had taken -- to correct the cited deficiencies. CMS Ex. 1. Concerning the deficiencies cited under tags F225 and F309, the plan of correction indicates that the facility had, among other things: (1) "inserviced" (provided training or instruction to) the nursing staff about the need to report allegations and incidents of abuse to the administrator; and (2) inserviced staff regarding the handling of suspected head injuries pursuant to the facility's Accident and Incident Report policy. Id. at 3, 5, 7. The plan also indicates that this inservicing was not completed until June 11, 1997. Because Spring Meadows has made no attempt to discount the importance or necessity of this corrective action in attaining substantial compliance, we see no basis to disturb the ALJ's finding that Spring Meadows did not bring itself into substantial compliance with all participation requirements until June 8 (three days before it completed inservicing).

26. The regulations state that a per day penalty continues to accrue until the date of a revisit survey verifying substantial compliance, unless the facility submits "documentation acceptable to CMS or the State agency that substantial compliance was achieved on a date preceding the revisit," in which case the per day penalty ceases on the "date of correction for which CMS and the state receive and accept written credible evidence." 42 C.F.R. �� 488.454(a), 488.440(h)(1).