CASE | DECISION |JUDGE | FOOTNOTES

Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
IN THE CASE OF  


SUBJECT:

Weatherford Health Care Center,

Petitioner,

DATE: February 04, 2004
                                          
             - v -

 

Centers for Medicare & Medicaid

 

Docket No.C-01-1014; C-02-0122
Decision No. CR1139
DECISION
...TO TOP

DECISION

Petitioner, Weatherford Health Care Center (Petitioner or facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner initiated these matters to challenge the Centers for Medicare & Medicaid Services' (CMS's) determinations that, based on the findings of surveys ending June 29, 2001, August 24, 2001, and September 19, 2001, Petitioner was not in substantial compliance with program participation requirements, and that, from September 16 through 20, 2001, its deficiencies posed immediate jeopardy to resident health and safety. Petitioner now declines "to actively litigate" the June 29, 2001 survey findings, and agrees to pay the $1,000 per instance civil money penalty (CMP) imposed as a result of the deficiencies cited during that survey. (1) Petitioner's (P.) Brief at 2. CMS subsequently rescinded the penalties imposed following the August 24, 2001 survey. CMS Brief at 3. Thus, only the initial determinations stemming from the September 2001 survey are currently before me.

As explained below, I conclude that from September 16 through 20, 2001, the facility was out of compliance with program requirements, that its deficiencies posed immediate jeopardy to resident health and safety, and that the amount of the CMP, $10,000 per day for five days, is reasonable.

I. Background

As a condition for participation in the Medicare and Medicaid programs, skilled nursing facilities (SNFs) (Medicare) and nursing facilities (NFs) (Medicaid) periodically undergo surveys to determine whether they are in substantial compliance with program requirements, and the Secretary of Health and Human Services contracts with state survey agencies to conduct those surveys. Social Security Act (Act), section 1864(a); 42 C.F.R. § 488.20. The regulations require that each facility be surveyed at least once every 12 months, and more often, if necessary, to ensure that identified deficiencies are corrected. 42 C.F.R. § 488.20(a).

In this case, on June 29, 2001, the Texas Department of Human Services (State Agency) completed a complaint investigation/standard compliance survey, and concluded that the facility did not meet requirements for Resident Rights (42 C.F.R. § 483.10(b)(11)), Resident Behavior/Facility Practices (42 C.F.R. § 483.13(c)), Quality of Life (42 C.F.R. § 483.15(h)(2)), Quality of Care (42 C.F.R. §§ 483.25 and 483.25(m)(1)), Physical Environment (42 C.F.R. § 483.70(h)(4)), and Administration (42 C.F.R. §§ 483.75(e)(4) and 483.75(f)). Among other specific findings:

•On May 16, 2001, a non-certified nurse aide improperly attempted to transfer a resident who fell (or "was placed") on the floor, likely sustaining a leg fracture that was not reported or treated for many days. CMS Exhibit (Ex.) 1, at 1-8.

•The surveyors set forth a long and detailed list of housekeeping and maintenance deficiencies, including fecal stains, dried urine stains, an accumulation of dead insects, "grime and soil," broken tiles, and, in one room, a "chronic offensive odor." CMS Ex. 1, at 12-17.

•The facility was infested with flies. CMS Ex. 1, at 31-32.

•The surveyors reviewed the care of five residents undergoing kidney dialysis. Not one of those five was weighed and/or assessed before and after dialysis, as required by his/her care plan. The facility had no means by which to ensure that residents undergoing dialysis received their meals. In one case, facility staff failed to follow physician orders for fluid restriction. CMS Ex. 1, at 17-24.

•The surveyors reported a medication error rate of 10%. CMS Ex. 1, at 26-27.

•Nurse aides who had not completed an approved nurse aide training program were providing direct patient care without supervision. CMS Ex. 1, at 32-35.

•Certified nurse aides were not able to demonstrate competence while performing transfers or in applying a condom catheter. CMS Ex. 1, at 35-38.

CMS agreed with the State Agency conclusions, and, by letter dated July 23, 2001, advised the facility that it was not in substantial compliance with federal requirements, and that CMS was imposing a DPNA (denial of payment for new admissions), effective September 29, 2001, and a per instance CMP of $1,000. CMS Ex. 32, at 1-2. (2)

The state surveyors revisited the facility on August 24, 2001, citing deficiencies under Quality of Life (42 C.F.R. § 483.15(h)(2)) and Dietary Services (42 C.F.R. § 483.35(h)(2)). By letter dated September 11, 2001, CMS advised the facility that it had not achieved substantial compliance, but "the situation that had led to the finding of immediate jeopardy had been removed." (3) The letter advised that the DPNA and the $1,000 per instance CMP remained in effect. In addition, the facility's provider agreement would terminate on October 29, 2001, and CMS imposed an additional per instance CMP in the amount of $3,050. CMS Ex. 32, at 3-4.

In a letter dated September 21, 2001, Petitioner timely appealed both surveys. The case was docketed C-01-1014, and assigned to me.

In the meantime, on September 16, 2001, a seriously mentally ill resident eloped from the facility and was killed when struck by a pickup truck four miles away. P. Ex. 4. After receiving a report of the incident, state surveyors returned to the facility, and conducted a complaint investigation survey from September 17 through 19, 2001. CMS Ex. 20. The surveyors determined that the facility was not in substantial compliance with federal requirements for Resident Assessment (42 C.F.R. § 483.20(k)(3)(i)) and Quality of Care (42 C.F.R. §§ 483.25 and 483.25(h)(2)), and that the conditions posed immediate jeopardy to resident health and safety. In a letter dated September 24, 2001, CMS advised the facility that it agreed with the state's assessment. The termination date for the facility's provider agreement was moved up to October 12, 2001, and the date of the DPNA changed to September 26, 2001. CMS also imposed state monitoring. In addition to the CMPs already imposed, CMS added a CMP in the amount of $10,000 per day, beginning September 16, 2001, continuing until the facility achieved substantial compliance or its provider agreement terminated. CMS Ex. 32, at 5-6.

The State Agency subsequently determined that the facility had achieved substantial compliance. CMS agreed, and, by letter dated October 23, 2001, advised Petitioner that neither the DPNA nor termination would be imposed. The CMP of $10,000 per day was discontinued as of September 21, 2001. The facility's total CMP was therefore $54,050. (A $1,000 per instance CMP, a $3,050 per instance CMP, and a $10,000 per day CMP for five days). CMS Ex. 32, at 7-8. Petitioner again timely appealed, the appeal was docketed as C-02-0122, and assigned to me. In a motion filed June 7, 2002, Petitioner asked that its two appeals be consolidated. CMS did not object, and, by order dated August 22, 2002, I consolidated the two matters.

While these cases were pending, CMS rescinded the $3,050 CMP imposed following the August 23, 2001 survey.

CMS has moved for summary judgment. Petitioner opposes, arguing that "there is in deed (sic) a fact issue as to whether [Petitioner] was in compliance with the regulations at issue in this case," and

a fact issue also remains as to whether enforcement actions taken by CMS, namely the declarations of Immediate Jeopardy and Substandard Quality of Care and the imposition of Civil Money Penalties, were appropriate based not only on the facts that existed prior to the incident with the resident, but also the extensive actions that the facility took immediately after this incident . . . .

P. Brief at 11.

The parties have submitted proposed exhibits. Petitioner has submitted nineteen exhibits (P. Exs. 1-19) and two declarations. CMS has submitted thirty-two exhibits. (CMS Exs. 1-32). In my April 26, 2002 order, I directed the parties to exchange "as a proposed exhibit" the complete written direct testimony of any proposed witness. Petitioner submitted declarations, but did not include them as proposed exhibits. More significant, the Bryant declaration is unsigned, with a note that the signature was "unavoidably delayed," but would be forthcoming. To date, Petitioner has not submitted a signed declaration. I have nevertheless treated the document as a signed declaration for purposes of this decision.

For its part, CMS promised its supporting affidavits "as soon as possible," but, until very recently, failed to submit any. (4) Nevertheless, as set forth in my order and as provided in Rule 56, Federal Rules of Civil Procedure, summary judgment may be appropriate without supporting affidavits or even exhibits from the moving party:

I will hear and decide each motion for summary disposition according to the principles of Rule 56 of the Federal Rules of Civil Procedure and applicable case law. A party moving for summary disposition need not offer supporting affidavits or exhibits but it must state concisely in its motions those material facts it contends are not in dispute. A party opposing a motion for summary disposition must state in its opposition those material facts that it asserts to be in dispute. It is never sufficient for a party opposing a motion to aver only that it "disputes" alleged facts or that it demands an in-person hearing.

Order Setting Pre-hearing Exchanges and Establishing Additional Procedures, at 4, ¶ 9 (April 26, 2002).

In the absence of any objections, and for purposes of this summary judgment ruling, I admit P. Exs. 1-19, CMS Exs. 1- 32, and the written direct testimonies of Sharon Bryant and Greg Moore.

II. Issues

I consider first whether summary judgment is appropriate.

Petitioner declines to litigate the June 29, 2001 survey findings, and agrees to pay the $1,000 per instance CMP. CMS has withdrawn the penalty for the August 24, 2001 survey. Thus, on the merits, the following issues remain:

1. Whether, from September 16 through 20, 2001, the facility was in substantial compliance with program participation requirements, specifically, 42 C.F.R.§ 483.25 (Quality of Care) and 42 C.F.R. § 483.20(k)(3)(i) (Resident Assessment).

2. If the facility was not in substantial compliance, did its deficiencies pose immediate jeopardy to resident health and safety?

3. If the facility was not in substantial compliance, is the amount of the Civil Money Penalty imposed, $10,000 per day (total of $50,000), reasonable?

III. Statutory and Regulatory Background

The Act sets forth requirements for nursing facility participation in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facility participation in the Medicare program are found at 42 C.F.R. Part 483.

Facilities must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. § 488.301. A facility's noncompliance constitutes immediate jeopardy if it has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." Id. Immediate jeopardy can exist regardless of the scope and severity of the deficiency, so long as the deficiency involves a potential for more than minimal harm. Lake City Extended Care Center, DAB No. 1658, at 17 (1998). CMS's determination as to immediate jeopardy must be upheld unless "clearly erroneous." 42 C.F.R. § 498.60(c)(2); Bergen Regional Medical Center, DAB No. 1832 at 9, fn 9 (2002).

The facility must conduct, initially and periodically, a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity. 42 C.F.R. § 483.20. The facility must also develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, mental, and psychosocial needs that are identified in the comprehensive assessment. Among other requirements, the care plan must be developed within seven days after completion of the comprehensive assessment. It must be prepared by an interdisciplinary team, and reviewed periodically by a team of qualified persons. Services provided or arranged by the facility pursuant to the care plan must meet professional standards of quality. 42 C.F.R. § 483.20(k).

Under the statute and "quality-of-care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychological well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. § 483.25. Specifically, the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. § 483.25(h)(2).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. § 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. CMS increases the per day penalty amount for any repeated deficiencies for which a lower level penalty was previously imposed. 42 C.F.R. § 488.438.

In setting the amount of the CMP, CMS considers 1) the facility's history of noncompliance; 2) the facility's financial condition; 3) factors specified in 42 C.F.R. § 488.404; and 4) the facility's degree of culpability, which includes neglect, indifference, or disregard for resident care, comfort, or safety. The absence of culpability is not a mitigating factor. 42 C.F.R. § 488.438(f). The factors in section 488.404 include 1) the scope and severity of the deficiency; 2) the relationship of the deficiency to other deficiencies resulting in noncompliance; and 3) the facility's prior history of noncompliance in general and specifically with reference to the cited deficiencies.

IV. Discussion

A. Summary disposition is appropriate because Petitioner has not demonstrated any dispute over genuine issues of material fact. (5)

Unless the parties raise a genuine issue of material fact, an administrative law judge (ALJ) may decide a case on summary judgment without an evidentiary hearing. Carrier Mills Nursing Home, DAB No. 1883 (2003) Livingston Care Center, DAB No. 1871 (2003); Crestview Parke Care Center, DAB No. 1836 (2002); Everett Rehabilitation and Medical Center, DAB No. 1628, at 3 (1997); Carmel Convalescent Hospital, DAB No. 1584, at 27 (1996). To defeat a motion for summary judgment, the non-moving party may not rely on the denials of its pleadings, but is required to tender evidence of specific facts, in the form of affidavits and/or admissible discovery material, in support of its contention that a dispute exists. Crestview at 6 (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 n.11 (1986)).

In determining whether this case can be decided by summary judgment, I apply the standard articulated by the Board in Crestview. I evaluate Petitioner's rationale for its alleged disputes of fact and its proffered evidence "to see if a genuine dispute of fact has been raised." If I conclude that such a dispute has been raised, for summary judgment purposes, I resolve that dispute in favor of the nonmoving party, "just as if it had been established by a preponderance of the evidence." Crestview, DAB No. 1836, at 8. See also Carmel Convalescent, DAB No. 1584, at 22 (Where the petitioner had the opportunity to present its case with briefs and supporting documentation, but did not demonstrate a genuine dispute of material fact, the Board affirmed summary disposition) and Glenburn Home, DAB No. 1806, at 17 (2002) ("[I]n reviewing a case where an ALJ failed to either obtain a written waiver or hold an oral hearing, we may nonetheless uphold the decision if the affected party either had conceded all of the material facts or proffered testimonial evidence only on facts which, even if proved, clearly would not make any substantive difference in the result.")

Here, CMS has come forth with a list of its findings and has set forth its rationale for determining substantial noncompliance at the time of the September survey. Petitioner has responded with documentary evidence and declarations of witnesses. For purposes of resolving this motion for summary judgment, I wholly accept Petitioner's assertions of fact. Resident #1 (R1) was admitted to the facility on August 21, 2001. He had suffered a cerebral vascular accident with aphasia. He had dementia with delusions and was paranoid. He also had emphysema. P. Ex. 2, at 7; P. Ex. 3, at 6, 10. Petitioner concedes that, at the time of his admission, the responsible nurse failed to complete R1's initial assessment. Specifically, she did not complete that portion of the assessment form that addressed his risk for wandering. P. Brief at 4; Bryant Decl. at 6. Nevertheless, R1 resided at the facility without significant incident for several weeks, until the night of September 16, 2001, when he left the facility and was killed. Facility staff were not aware that he was missing, and only learned of it at 11:40 p.m. when R1's daughter called to tell them. Petitioner admits that staff failed to conduct a required visual check of all residents, and that nurses responsible subsequently lied about their dereliction. P. Brief at 5; See P. Ex. 3, at 64; P. Ex. 4, at 14. A staff member had last seen R1 at about 8:30 to 8:45 p.m., wandering outside the facility, but did not report the observation, nor take any other action. Bryant Decl. at 10-11; P. Ex. 3, at 64; P. Ex. 4.

Petitioner nevertheless argues that summary judgment is not appropriate, citing fact issues "as to whether [the facility] was in compliance," and the appropriateness of CMS's enforcement actions. P. Brief at 11. Whether the undisputed facts amount to substantial noncompliance, whether they establish immediate jeopardy, and whether they justify the imposition of a CMP are not questions of fact; they are questions of law. Petitioner also points to the facility actions following R1's death, which, it claims, "virtually eliminated any possibility of any resident leaving the facility without authorization." P. Brief at 11. For summary judgment purposes, however, I accept Petitioner's factual assertions as to its actions in correcting the cited deficiencies - although I do not accept the conclusions Petitioner reaches based on those facts. As the following discussion shows, Petitioner has not demonstrated the existence of a dispute of material fact, and, therefore, summary judgment is appropriate.

B. From September 16 through 20, 2001 the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R. § 483.25 (Quality of Care) and § 483.20 (Resident Assessment), and the facility's level of noncompliance posed immediate jeopardy to resident health and safety .

The quality of care regulation, 42 C.F.R. § 483.25, imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." Windsor Health Care Center, DAB No. 1902, at 16-17 (2003); Woodstock Care Center, DAB No. 1726, at 25-30 (2000). Among other requirements, the facility must ensure that its supervision is adequate to prevent accidents. This requirement does not amount to strict liability or require absolute success in an obviously difficult task. Using an outcome-oriented approach, facilities have the flexibility to use a variety of methods, but they are responsible for achieving the required results. In ensuring adequate supervision, the facility is not required to do the impossible or be a guarantor against unforeseeable occurrence, but it is required to "take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents." 42 C.F.R. § 483.25(h); Windsor Health Care Center at 5 (2003); Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester Pavillion, DAB No. 1750, at 25-26; Woodstock Care Center at 25.

CMS alleges that Petitioner fell short of this standard. Citing the circumstances surrounding R1's death as well as other survey findings, CMS argues that the facility had no effective system in place for identifying who was at risk to wander, what to do if a resident exhibited such problematic behavior, and how to "track and/or trend how often the behavior occurred." Nor had the facility a system in place for ascertaining the whereabouts of its residents. CMS Ex. 20, at 1.

Petitioner concedes that it made two errors with respect to its treatment of R1. First, at the time of his admission, staff failed to assess his risk for wandering. Bryant Decl. at 7. Second, during the 10:00 p.m. shift change on September 16, 2001, staff did not check to insure that R1 was safely in the facility. Petitioner minimizes the significance of these errors, however, arguing that its staff's failings were not related to R1's elopement and subsequent accident. According to Petitioner, the inadequacy of R1's initial assessment was of little consequence because he thereafter resided at the facility without such incident, and a comprehensive assessment, performed 14 days later, did not indicate that he was a serious risk for elopement. The nurses' failure to check on R1 the night of the accident did not matter because R1 was already dead at the time they were required to do so. Petitioner characterizes R1's actions as "isolated," and claims that it could not have anticipated them because he had no history of any attempts to wander. P. Brief at 3.

Petitioner's efforts to distance its errors from R1's accident are misplaced. Although the evidence strongly suggests that the inattention of facility staff contributed to R1's elopement and subsequent death, I need not even reach that issue in order to find substantial noncompliance posing immediate jeopardy. A finding of immediate jeopardy is not contingent on a finding of actual harm. Immediate jeopardy encompasses situations where there is a likelihood of serious harm. Fairfax Nursing Home, Inc., DAB No. 1794, at 14 (2001). And the facility's errors here certainly created a foreseeable likelihood of serious harm. Without regard to his elopement risk, I find that the facility acted unreasonably in leaving a deeply paranoid individual unsupervised for long stretches of time. As the evidence shows, the facility recognized that R1's mental state put him in jeopardy for accidents, yet took no discernable steps to protect him.

First, with respect to the missing initial assessment, Petitioner concedes that, had the appropriate assessment been performed at the time of his admission, R1 would have been assessed as at high risk for wandering, and would have been placed on wandering precautions "based solely on being a new resident with a diagnosis of dementia." P. Brief at 4; Bryant Decl. at 7. Indeed, according to the facility's assessment tools, for a newly admitted resident, the presence of any one of five factors meant that he/she was at high risk for wandering, and staff were directed to implement a prevention plan. P. Ex. 3, at 14. R1 displayed three of the five factors: he was ambulatory, taking medication that can cause confusion, and had well-documented dementia. P. Ex. 3, at 14-15, 17.

Petitioner does not dispute the importance of assessing the elopement/wandering risk posed by a new resident who is mobile, demented, and paranoid. Here, apparently because a staff member was distracted, R1's risk was not assessed and no precautions were taken. No one even noticed the oversight for two weeks. That a tragedy did not occur was fortuitous, but the facility obviously had no plan in place to protect R1 and no system for catching a significant staff error.

I wholly accept that R1 had no history of wandering and no wandering incidents during his first weeks at the facility. However, according to the facility's assessment tools, history alone was not dispositive of the risk. Even for a resident who was not a new admission, the presence of any one of the five factors placed the resident "at risk" for wandering and staff were directed "to implement a prevention plan of care for wandering." P. Ex. 3, at 14. Again, Petitioner concedes that R1 met three of the listed factors: he was ambulatory; he took medication that can cause confusion or disorientation; and he was demented.

According to DON Bryant, however, those factors did not necessarily place R1 at risk for wandering, and did not necessarily compel the facility to implement a care plan to prevent wandering. Pointing to a policy "clarification" in effect at the time of R1's 14-day assessment, DON Bryant explains that for an ambulatory resident, the presence of a listed factor was only a "beginning point upon which to initiate an evaluation of whether the resident truly is a wanderer." P. Ex. 9; Bryant Decl. at 8. The policy clarification says that the presence of any of the listed factors:

indicates that the resident should be reviewed by the care plan committee to determine if he/she may be a wander risk. This discussion and the result should be documented in the clinical record. An interdisciplinary plan of care should be developed if the resident is identified as at potential risk or risk of wandering.

P. Ex. 9, at 1. Petitioner offers no evidence that the care plan committee discussed and documented R1's risk. Among the assessments performed within 14 days, I see no assessment of his risk for wandering. Instead, DON Bryant, on her own, determined that he posed no risk, based solely on his history. Bryant Decl. at 9. (6)

Even assuming that DON Bryant reasonably determined that R1 posed no risk for elopement or wandering, he was seriously demented, paranoid, taking psychotropic medications, and was unquestionably at risk for some incident or accident. An assessment of his cognitive loss/dementia dated September 6, 2001 identified an "acute confusional state" and resistance to care (refusal to take necessary medications) as behavioral problems. P. Ex. 3, at 45, 47. R1 had a history of refusing to eat due to fear of poisoning, and this behavior continued during his weeks at the facility. P. Ex. 3, at 49. See also P. Ex. 3, at 60, 61 ("afraid we are trying to poison him"). By the end of August, staff reported increased anxiety and put him on Ativan, a tranquilizer that can increase confusion. CMS Ex. 26. To address his psychiatric problems, his physician ordered a new medication, Zyprexa, on September 6. P. Ex. 3, at 68. Zyprexa (olanzapine) has the potential to impair judgment, thinking, and motor skills. See www.zyprexa.com (Eli Lilly and Company 2003).

R1's care plan suggests that the facility recognized that his dementia could lead to accidents, because it sets as a short-term goal that "he will not experience an incident or accident for 90 days." But the plan offers no clear indication as to what staff should do to prevent accidents. The approaches listed are general and do not seem particularly related to achieving that goal (address resident by name, allow him time to respond, answer questions with yes/no answers). P. Ex. 3, at 50.

The facility had no system in place for maintaining a reasonable account of R1's whereabouts. I see no evidence of any monitoring. No staff member seemed to be responsible for him. On the date of his accident, the facility allowed this demented and paranoid individual to remain outside, unsupervised after dark. (7) No one even realized that he was missing until more than two hours after his death. According to the facility incident report, he was seen by staff members at approximately 8:45 p.m. P. Ex. 4. (8) Someone taking out the trash saw him "walking around the laundry building." P. Ex. 4, at 6. A nursing note written at 11:40 p.m. the night of September 16, indicates that the resident's daughter called to say that the police found R1 at 9:20 p.m. on Bethel Road. He had been hit by a car and killed. The police subsequently called the facility with the same information. P. Ex. 3, at 64-65.

This case is more akin to the situation in Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001) than to an elopement case. Southridge presented no question of elopement. A competent but physically disabled resident slipped down an embankment and was unable to climb back out and return to the facility. Although staff noted his disappearance and attempted to find him, the Board found it "incumbent upon Petitioner's staff to locate or attempt to locate the resident in as systematic and expeditious manner as possible" in order to satisfy its "affirmative duty" to provide supervision sufficient to achieve a favorable outcome. Southridge at 10. Among other failings, the facility had not followed its own "missing resident" protocol, nor appropriately intensified its search. Here, the facility did not even come close to Southridge's admittedly inadequate level of performance since it did not identify the resident as missing, much less take any action to locate him. And, sadly, the outcome here was more dire than that in Southridge where the resident was eventually found in good health. (9)

The only monitoring system the facility had in place to keep track of R1 appears to have been a required visual check of every resident at every shift change. I find this insufficient to protect an individual with R1's level of dementia. In any event, Petitioner concedes that staff did not even perform this minimal task:

[T]he nursing staff is supposed to provide [a] report to each other and make a visual check of all residents in the facility at the change of shift. It is true that on the night of the resident's elopement, the nursing staff [who] was to make these walking rounds and visually check on the residents did not do so pursuant to the facility policy on this one occasion.

(Emphasis added) P. Brief at 5. Two nurses were supposed to have made these rounds. One claimed to have been "too weak, in too much pain, and too tired" to make the rounds (raising significant questions as to the quality of care she was providing). Bryant Decl. at 11. The other simply did not do so for reasons that are not explained and she then lied about it, writing in the medical record:

Walking rounds made [at change] of shift by this lvn [and weekend] lvn. Rm was [dark]. . .thought I saw res. foot in bed.")

P. Ex. 3, at 64; CMS Ex. 24, at 2; P. Brief at 5; Bryant Decl. at 10. The nurse who made this entry was subsequently disciplined for her failure "to assure all residents were in their proper place" at the change of shift. P. Ex. 4, at 14. Although seemingly acknowledging that the staff's malfeasance was "not insignificant," Petitioner attempts to minimize its importance by pointing out that R1 was already dead by the time the visual check should have occurred. P. Brief at 5.

That R1 had already been killed in no way lessens the seriousness of the staff misconduct. Failure to perform an essential service and then falsifying a medical record to cover up that failing constitutes a serious breach that by itself creates a likelihood of serious harm.

Based on the uncontroverted evidence, I find that the facility failed to take reasonable steps to mitigate foreseeable risks of harm from accidents. It was therefore not in substantial compliance with program participation requirements and its deficiencies posed immediate jeopardy to resident health and safety, and constituted substandard quality of care.

C. The duration of the CMP is consistent with statutory and regulatory requirements.

The day following R1's death, the facility began to implement changes. Greg Moore, Regional Vice President for the corporation that owns and operates the facility, explained the facility actions. First, the managers looked at the systems the facility then had in place to protect residents. According to VP Moore, the facility already had an alarm system in place, because chimes sounded when a door was opened. They did not consider this adequate, however, because the chimes stopped when the door closed. Moore Decl. at 6. By Monday afternoon, staff had been placed at all six exit doors and the facility increased the volume on the door chimes. In VP Moore's opinion, the placement of staff at the doors eliminated the potential for harm. Id. at 7.

Regional and facility nurses evaluated all of the residents to determine which were at risk for wandering. Eight residents (3, 4, 5, 6, 7, 8, 9 and 10) were identified as at risk for wandering. Residents 2 and 11 were identified as at risk for elopement. The residents identified as at risk for wandering were put on 30-minute to one-hour checks. (10) Those that tended to leave the facility were to be discharged within a day or two. The facility also contracted with a company to install a Wanderguard system, although that was going to take additional time to accomplish. Id. at 10-11.

Because of these efforts at correction, Petitioner asserts that its conditions posed no immediate jeopardy to residents, or, if its conditions posed immediate jeopardy to residents, the period ended before September 20, 2001. P. Brief at 10. Petitioner argues:

[O]ur understanding of a declaration of immediate jeopardy was that it had to be based on current conditions at the facility that represent an immediate harm to residents. We truly felt that we removed any such condition by implementing our new system, before the immediate jeopardy was cited. Therefore, the immediate jeopardy should have never been cited, based on the current conditions of the facility.

Moore Decl. at 8. Petitioner not only misunderstands the rules governing immediate jeopardy, but also seriously underestimates the seriousness of its deficiencies. It is undisputed that Petitioner acted to address the deficiencies that gave rise to the immediate jeopardy determination, but Petitioner has neither demonstrated that the determination was clearly erroneous, nor that the jeopardy was abated before CMS deemed compliance was achieved on September 20, 2001 (see CMS Ex. 32, at 7).

Underlying the immediate jeopardy finding were some serious problems with staff performance. One of the facility's nurses, described by her supervisor as "one of the best nurses that we have," simply failed to complete a necessary assessment and, for two weeks, no one caught the error. Two other nurses deliberately refused to perform the fairly undemanding, but critical task of making rounds. One of them then falsified a medical record to cover for it. These are not the kinds of problems that resolve themselves by management fiat. Staff still had to be trained in the new procedures, and monitored to insure that those procedures were appropriately implemented. See, e.g., P. Ex. 8 (showing staff in-service conducted September 19-22), and P. Ex. 8, at 34 ("New action plan put in place as of 9/19/01.").

Moreover, assuming Petitioner's actions were effective, Petitioner's own documents suggest that correction could not have occurred before September 20, 2001. For instance the facility's "Immediate Action Plan" (P. Ex. 7, at 1) and related in service reports (P. Ex. 7, at 2-15) are dated September 17, 2001; the documents Petitioner submitted to demonstrate its new policy for monitoring residents prone to wandering, addressing improved door alarms and policy concerning missing resident procedures are dated September 19, 2001 ( P. Ex. 8); and the in-service reports showing that staff were trained in the new policies are dated September 20, 2001 (P. Ex. 8, at 8). The facility implemented its new policies in stages. So, while Petitioner may have acted quickly, the record does not establish that the immediate jeopardy resolved instantaneously upon Petitioner's decision to implement new policy. On this basis alone, I could not find clearly erroneous CMS's determination that immediate jeopardy existed from September 16 to September 20, 2001.

Further, the posting of guards obviously did not prevent residents from exiting the facility. According to VP Moore, R2 was at risk for elopement and the facility's own documents identify her as at risk for elopement ( P. Ex. 10, at 2; CMS Ex. 30, at 39; CMS Ex. 20, at 12). Moore Decl. at 10. DON Bryant disputes the characterization, conceding that R2 wandered, but arguing "the mere fact that she was observed once outside the facility should not be stretched to equal an elopement risk." In any event, no one disputes that R2 wandered, that she had dementia, was mobile in her wheelchair, and had expressed a desire to return home. P. Ex. 17, at 3, 4, 5, 11, 13, 14. On the evening of September 17, after the guards had purportedly been posted, she exited the facility and was found attempting to leave. P. Ex. 17, at 3. According to CMS, staff reported that they were not aware that R2 had left the building, but learned of it during the evening meal when visitors reported observing her out by the laundry building. CMS Ex. 20, at 10-11. Petitioner has not disputed that assertion.

The Board has repeatedly explained that under the regulatory scheme, any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility that need to be corrected. Barn Hill Care Center, DAB No. 1848, at 12-18 (2002); Lake City at 14. Since I found that the deficiencies cited have the potential for more than minimal harm, I must also find that the facility was out of compliance "from the date of the completion of the survey in which [these] deficiencies were cited until the date of the resurvey in which substantial compliance was established." Lake City at 14-15. Substantial compliance means not only that the specific cited instances of substandard care were corrected, and that no other instances have occurred, but also that the facility has implemented a plan of correction designed to assure that no such incidents occur in the future. No findings that the facility violated the standard of care between these dates are required in order to find the facility out of substantial compliance, nor can evidence of other incidents in which the facility met the standard of care change the fact that it was out of substantial compliance. Barn Hill; Lake City at 15. See also Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002) (The burden is on the facility to prove that it has resumed complying with program requirements, not on CMS to prove that deficiencies continued to exist after they were discovered.); Asbury Center at 19-20 ("[A] facility's return to substantial compliance must usually be established through a resurvey, and in a situation involving inadequate supervision, requiring such a resurvey seems wise."); Cross Creek.

I note finally that neither party submitted a copy of the facility's plan of correction, and, possibly, the facility did not submit one. (11) It seems unusual for a facility with this level and quality of problem to be found in compliance after such a short period: just five days. Compare, e.g., Asbury Center (28 days and 30 days). Ironically, the facility may have benefitted from the State Agency's perception that the seriousness of its deficiencies required state monitoring. Ordinarily, receipt and review of a written plan of correction followed by a revisit survey necessarily lengthens the time for imposition of a CMP. Here, however, possibly because the state monitors were present, the facility was found in substantial compliance at the first possible opportunity.

D. The amount of the CMP Imposed against Petitioner, $10,000 per day for 5 days, is reasonable.

Having found a basis for imposing a CMP, I now consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. § 488.438(f). It is well-settled that, in reaching a decision on the reasonableness of the CMP, I may not look into CMS's internal decision-making processes. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved. (financial condition, facility history, culpability). I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard for CMS's discretion. Barn Hill at 21; Community Nursing Home, DAB No. 1807, at 22 et seq. (2002); Emerald Oaks, DAB No. 1800, at 9 (2001); CarePlex of Silver Spring, DAB No. 1683, at 8. For this reason, I reject Petitioner's argument that because a tag was removed at the state IDR proceeding, after CMS had set the amount of the CMP, the facility should not be accountable for the full amount of the penalty. (12)

CMS has imposed a penalty of $10,000 per day, which is the maximum amount for an immediate jeopardy situation ($1,000 - $10,000 per day). I recognize that, even though imposed for only five days, because this is the maximum, its imposition should be reserved for those situations that are particularly egregious, based on the factors provided in section 488.438(f). After carefully reviewing the circumstances of this case in light of those factors, I am not able to find the amount unreasonable.

I consider very significant the facility's history of noncompliance. Less than three months earlier, during the June 29, 2001 survey, CMS found many significant deficiencies, including quality of care deficiencies. Moreover, the kinds of deficiencies cited involved staff neglect, error, and malfeasance at levels similar to those discussed here. One resident sustained a serious injury in the care of an unqualified nurse aide who then failed to report the injury. Other staff knew of the incident, but failed to report it. CMS Ex. 1, at 1-8. The survey cites many examples of staff ignoring treatment plans for its dialysis patients. CMS Ex. 1, at 17-24. The surveyors reported a medication error rate of 10%. CMS Ex. 1, at 26-27. Unqualified and incompetent staff were allowed to provide care. CMS Ex. 1, at 35-38. Unfortunately, the lenient penalty CMS imposed following the June survey was apparently insufficient to produce and sustain the necessary level of corrective action.

The record is silent as to the facility's financial condition. The facility must timely raise its claim that a particular factor makes a CMP unreasonable before any question arises as to CMS's responsibility for producing evidence as to that factor. Community Nursing at 22.

Applying the remaining factors, I find that the deficiencies cited were extremely serious, and that the facility was culpable. The facility is responsible for the consequences of its employees' actions. Emerald Oaks at 7 n. 3. Here, facility employees not only failed in their responsibilities, two of them lied, and one falsified a medical record in order to cover up her negligence. (13) I consider fabricating documentation to be an especially dangerous practice, which can be difficult to detect, and which seriously undermines the Agency's ability to review facility practices, as well as the facility's ability to provide adequate care. I find that this level of culpability warrants a very severe penalty.

Based on these factors I am unable to find unreasonable CMS's determination to impose, for a limited time, the maximum CMP of $10,000 per day.

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that from September 16 through 20, 2001, the facility was not in substantial compliance with program participation requirements, specifically, 42 C.F.R. § 483.25 (Quality of Care) and 42 C.F.R. § 483.20(k)(3)(i) (Resident Assessment). Its deficiencies posed immediate jeopardy to resident health and safety, and the amount of the CMP imposed, $10,000 per day for five days (total of $50,000), is reasonable.

JUDGE
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Carolyn Cozad Hughes

Administrative Law Judge

FOOTNOTES
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1. Although Petitioner asserts that it does not concede the facts leading to the finding of noncompliance, its disinclination to pursue the appeal necessarily results in a final agency determination of substantial noncompliance .

2. A $1,000 per instance penalty seems surprisingly low given the scope and severity of the deficiencies cited during the June survey, but CMS offers no explanation for what Petitioner itself accurately characterizes as an "extremely limited remedy." P. Brief at 2.

3. This notice letter is hardly a model of clarity. During the August survey, the surveyors apparently found immediate jeopardy, and, during the same survey, they found that the immediate jeopardy situation was removed, hence the $3,050 CMP. I suspect also that, in assessing the amount of the CMP, CMS may have confused the rules for per instance penalties ($1,000 to $10,000 range) with those for per diem penalties ($3,050 to $10,000 per day range in immediate jeopardy situations). Compare 42 C.F.R. § 488.438(2) with 42 C.F.R. § 488.438(a)(1)(i).

4. I received the Affidavit of Daniel J. McElroy, R.N., on January 22, 2004. CMS did not indicate why this filing was made well over a year after the filing of CMS's prehearing brief and motion (received September 3, 2002). Despite the unexplained lag in filing the McElroy Affidavit, I need not decide whether to admit it. Mr. McElroy's statement concerns CMS's review of the survey findings and CMS's evaluation of the factors for making the remedy determination. This information is not relevant to my analysis of the reasonableness of the amount of CMP (see discussion in section IV. D. below).

5. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding in italics as a separate heading.

6. Following R1's death, the facility again clarified its policy. The re-clarified policy identified as "at risk" any resident who received a yes response to any one of the following questions: Is the resident resistant to being placed in a long-term care facility? Does the resident have a history of wandering? Is the resident currently taking any medication which may cause confusion or disorientation? Are there any indications of dementia? P. Ex. 7, at 1; P. Ex. 3, at 14. The care plan committee then reviews any resident identified as "at risk" to determine if the resident is a wandering risk. Any resident deemed an elopement risk would be discharged because the facility is not set up to provide care for them. A resident identified as at risk for wandering would be monitored every 30 minutes. In addition, the facility purchased door alarms and mandated rounds every 2 hours as well as walking rounds at change of shift in order to ensure residents' whereabouts. P. Ex. 7.

7. According to data from the U.S. Naval Observatory, Astronomical Applications Department, for this geographic location, sunset was at 7:35 p.m. on September 16, 2001. The "end of civil twilight" was at 7:59 p.m. "After the end of civil twilight, artificial illumination is normally required to carry on ordinary outdoor activities." http://aa.usno.navy.mil .

8. Of course, this raises an obvious question as to how R1 managed to travel so far, about four miles, in such a short time. Petitioner speculates that he was given a ride, but offers no particular evidence to support the speculation other than the time and location of his death. Moore Decl. at 13.

9. Petitioner submits its own "missing resident" protocol. P. Ex. 6. However, by its own terms, the resident must be identified as missing before any action is triggered. The document says nothing about monitoring the presence of residents at risk for accidents.

10. According to the written "action plan" dated September 17, 2001, every resident identified as "at risk" for wandering was to be monitored every 30 minutes. P. Ex. 7, at 1.

11. By letter dated September 21, 2001, the State Agency informed Petitioner that the CMP of $10,000 per day would be imposed from September 16, 2001 until a plan of correction was submitted and accepted, there was a finding of substantial compliance or the facility was terminated. The letter directed Petitioner to submit a plan of correction within 10 days of receiving the September 21, 2001 letter.

12. Moreover, the IDR action involved form rather than substance. The same deficiencies were cited under tag number F324.

13. I recognize that one of these nurses eventually admitted to the misconduct. P. Ex. 4, at 14.

CASE | DECISION | JUDGE | FOOTNOTES