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CASE | DECISION | JUDGE | FOOTNOTES

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


SUBJECT:

Price Hill Nursing Home,

Petitioner,

DATE: February 23, 2001
                                          
             - v -

 

Health Care Financing Administration

 

Docket No.C-98-171
Decision No. CR745
DECISION
...TO TOP

I decide that, during the time covered by the October 1997 survey, Petitioner, Price Hill Nursing Home (the provider), failed to be in substantial compliance with every Medicare participation requirement for which it was cited by the Health Care Financing Administration (HCFA). Accordingly, HCFA had the authority to impose a civil money penalty (CMP). I decide further that, on September 3, 1997, for one day only, the provider was not in substantial compliance with the only requirement alleged to be deficient at an immediate jeopardy level, Tag F-324, a quality of care requirement concerning accidents pursuant to 42 C.F.R. § 483.25(h)(2). HCFA's determination that the provider's noncompliance on September 3, 1997 was at an immediate jeopardy level was not clearly erroneous. Because of the immediate jeopardy finding, I conclude that $6,950 is a reasonable CMP, comprised of $3,050 for September 3, 1997, plus $50 per day for 78 additional days of noncompliance (September 4, 1997 through November 20, 1997).

I. Background

The provider is a skilled nursing facility located in Cincinnati, Ohio. The Ohio Department of Health (State survey agency)(1) conducted a survey of the provider from September 23 - 26, 1997, and on October 3, 1997. Those two surveys are referred to as the October 1997 survey. Based on the October 1997 survey, HCFA found that the provider was not in substantial compliance with Medicare participation requirements. HCFA Ex. 34.

HCFA imposed a $66,950 CMP, comprised of $3,050 per day for 21 days of immediate jeopardy (September 3, 1997 through September 23, 1997), plus $50 per day thereafter for 58 days of noncompliance (September 24, 1997 through November 20, 1997). HCFA found the provider to be in substantial compliance with Medicare participation requirements beginning November 21, 1997. HCFA Ex. 36.

The provider timely requested a hearing, which was held in Cincinnati, Ohio, from April 19 - 22, 1999. During the hearing, each party called witnesses to testify. The transcript of the hearing is referred to as Tr. HCFA Exhibits (HCFA Exs.) 1- 39 were admitted into evidence, but HCFA Ex. 33 was withdrawn. Post-hearing, HCFA Exhibit 40 was admitted into evidence. Petitioner Exhibits (P. Exs.) 1- 13 were admitted into evidence. The parties' opening briefs, referred to as P. Br. and HCFA Br., were filed in July 1999. The parties' reply briefs, referred to as P. R. Br. and HCFA R. Br., were filed in August 1999.

II. Applicable law

Skilled nursing facilities, such as the provider, participate in the Medicare program by entering into provider agreements with the United States Department of Health and Human Services (DHHS). Requirements of participation are imposed by statute and regulation. Social Security Act (Act), section 1819 [42 U.S.C. § 1395i-3]; 42 C.F.R. Parts 483, 488, and 489.

The regulations define "substantial compliance" as follows: "Substantial compliance means a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301.

The regulations define "immediate jeopardy" as follows: "Immediate jeopardy means 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." Id.

The regulations specify that a CMP that is imposed against a provider will fall into one of two broad ranges of penalties. Per-day CMPs in the lower range, from $50 per day to $3,000 per day, are imposed for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. Per-day CMPs in the upper range, from $3,050 per day to $10,000 per day, are imposed for deficiencies that constitute immediate jeopardy to one or more of a provider's residents. 42 C.F.R. §§ 488.408, 488.438(a).

The preponderance of the evidence standard is applied to resolve disputed issues of fact, except as provided by 42 C.F.R. § 498.60(c)(2), which states that, in CMP cases, HCFA's determination as to the level of noncompliance of a skilled nursing facility must be upheld unless it is clearly erroneous.

HCFA bears the burden of coming forward with evidence sufficient to establish a prima facie case that the provider was not in substantial compliance with the participation requirements at issue. Once HCFA has established a prima facie case, the provider has the ultimate burden of persuasion: to prevail, the provider must prove by a preponderance of the evidence that it was in substantial compliance with each participation requirement at issue. [See Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. United States, Department of Health and Human Services, Health Care Financing Administration, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999).]

III. Issues

The principal issue is whether the provider was in substantial compliance with Medicare participation requirements during the time covered by the October 1997 survey. A more specific issue is whether the provider was in substantial compliance with 42 C.F.R. § 483.25(h)(2), a quality of care requirement concerning accidents [Tag F-324]. If not, a further issue is whether the non-compliance under Tag F-324 resulted in immediate jeopardy, and if so, when the immediate jeopardy abated.

IV. Findings of fact and conclusions of law

Each finding of fact and conclusion of law (FFCL) identified here pertains to the time covered by the October 1997 survey. I discuss in detail only FFCLs 1 through 6 in the Discussion section, section V.


1.Quality of care: Accidents. On September 3, 1997, the provider did not ensure that each resident received adequate supervision and assistive devices to prevent accidents, as required under 42 C.F.R. § 483.25(h)(2) [Tag F-324].

2. Quality of care: Accidents. For one day only, September 3, 1997, the provider did not prove that it was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(h)(2) [Tag F-324].

3.
Quality of care: Accidents. For 20 days, September 4, 1997 through September 23, 1997, the provider proved that it was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(h)(2) [Tag F-324].

4.
HCFA's determination that the provider's noncompliance with 42 C.F.R.
§ 483.25(h)(2) [Tag F-324] on September 3, 1997 was at an immediate jeopardy level, was not clearly erroneous.

5.Since there was no deficiency under 42 C.F.R. § 483.25(h)(2) [Tag F-324] for 20 days, September 4, 1997 through September 23, 1997, there was no immediate jeopardy during those days.

    6. HCFA's determination that the provider's noncompliance was at an immediate jeopardy level from September 4, 1997 through September 23, 1997, was clearly erroneous.

    7.
    Quality of care: Accidents. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R.
    § 483.25(h)(1) [Tag F-323].

    8. Quality of care: Activities of Daily Living. The provider proved that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. § 483.25(a)(2) [Tag F-311].

    9. Infection control. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. § 483.65(a) (1) - (3) [Tag F-441].

    10.
    Resident rights: Privacy. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R.
    § 483.10(d)(3) [Tag F-164].


    11.
    Physical Environment: Pest Control. The provider did not prove that it was in substantial compliance with Medicare participation requirements specified in 42 C.F.R. § 483.70(h)(4) [Tag F-469].

    12.
    Physical Environment: Resident rooms. HCFA acknowledged that it would not be proceeding regarding 42 C.F.R. § 483.70(d)(1)(ii) [Tag F-458], which had been waived. Tr. 42.

    13.
    Quality of life: Dignity. HCFA withdrew its allegations that the provider was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.15(a) [Tag F-241]. Tr. 12.

    14.
    Quality of Life: Environment. HCFA failed to establish a prima facie case that the provider was out of substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.15(h)(2) [Tag F-253].

    15.
    Resident Assessment: Comprehensive care plans. HCFA failed to establish a prima facie case that the provider was out of compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.20(d) [Tag F-279]. Tr. 474-475.

    16.
    Life Safety Code. The provider did not prove that it was in substantial compliance with four life safety code requirements [Tag K-21, K-46, K-66, and K-68].

    17.
    HCFA had the authority to impose a CMP.

    18.
    A CMP in the amount of $6,950 is reasonable.

V. Discussion

On September 3, 1997, the provider did not ensure that each resident received adequate supervision and assistive devices to prevent accidents, as required under 42 C.F.R. § 483.25(h)(2) [Tag F-324]. For that one day only, there was immediate jeopardy.

Following the October 1997 survey, HCFA cited the provider with numerous deficiencies ("F-Tags"), one of which, Tag F-324, was cited at the immediate jeopardy level ("J" scope and severity). HCFA Ex. 3 at 12. The Statement of Deficiencies from the October 1997 survey, HCFA form 2567L, can be found as HCFA Exs. 2 and 3 (revised), and P. Ex. 1.

Surveyor Patricia Buczkowski, the team coordinator (leader), testified that the survey team members became concerned about the provider's supervision of five residents who had "WanderGuard" bracelets. The team questioned whether the provider was properly using and monitoring the audible movement alarm system to prevent the residents from eloping from the facility or exiting the facility without a staff member or supervision. Tr. 43 - 45. Of particular concern to the surveyors was whether the audible alarm bracelets were being tested. The surveyors articulated the theory that the provider had no system in place to monitor each resident's audible alarm bracelet to be sure that it was functional and the batteries were operational. HCFA Ex. 3 at 14 - 15. Ms. Buczkowski testified that the surveyors were trying to "tell if the facility was aware if the alarm was working or not." Tr. 93.

Mr. Wolfe testified that the surveyors thought that the bracelet system failed and that the system was not checked to see that everything was operational until September 26, 1997. Tr. 349.

Tag F-324 is a quality of care deficiency under 42 C.F.R. § 483.25(h)(2), which states:

42 C.F.R. § 483.25 Quality of care.

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.

(h) Accidents. The facility must ensure that-

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

42 C.F.R. § 483.25(h)(2).

Initially, to support the Tag F-324 citation, the situations of two residents, Resident 49 and Resident 52, were identified on the Statement of Deficiencies. HCFA Ex. 3 at 12 -17. The situation that was of most concern to the surveyors was that of Resident 52, who died following surgery after a fall from the front steps. Tr. 580 - 581, 588. The situation of Resident 52, however, was deleted from consideration by informal dispute resolution. Tr. 236, 499.

At the hearing, I informed the parties that my initial reaction was to find no deficiency under Tag F-324. Tr. 600. HCFA objected and I indicated that I would honor that objection. Id. In light of Woodstock Care Center, DAB No. 1726 (2000), I reverse my position. Woodstock was issued by an appellate panel of the Departmental Appeals Board. The within case is distinguishable from Woodstock. Nevertheless, in reliance on Woodstock, I do find a deficiency under Tag F-324.

HCFA urges me not to consider how difficult Resident 49 was to manage. HCFA states:

. . . the mental condition of Resident 49 has been raised as a concern or potential defense regarding this deficiency. However, Resident 49's difficult behavior does not vitiate the Facility's responsibility to adequately supervise him. It is true that Resident 49 was combative and difficult to control, and at times he posed a threat to others as well as himself. However, it was the Facility who chose to rely on an audible alarm system as a means of supervising Resident 49's wandering behavior. Obviously, if a facility relies on such a means to supervise wandering, a facility has to ensure that the system (including its main components of keypad and bracelet) are functioning properly. This is especially pertinent when a facility has had recent instances of elopement in which its staff were not aware of Resident 49's exit or where he was. Regardless of how difficult Resident 49 may have been to manage, as a resident of its facility, Petitioner was responsible for providing Resident 49 with adequate supervision and assistive devices to prevent accidents which it failed to do.

HCFA Br. at 6 - 7.

I agree with HCFA that "Resident 49's difficult behavior does not vitiate the Facility's responsibility to adequately supervise him." While 42 C.F.R. § 483.25(h)(2) does not impose strict liability upon a provider where a resident wanders unsupervised, the relevant inquiry is whether there was supervision which was adequate for the resident's situation. Heath Nursing and Convalescent Center, DAB CR610 at 6 (1999). This would involve consideration of a variety of measures designed to keep staff reasonably apprised of the resident's needs. The adequacy of measures which it takes to effectuate this requirement does place a high expectation on the provider to achieve results, but it does not amount to strict liability or require absolute success in an obviously difficult task. Woodstock, DAB No. 1726, at 27. See also Lakeland Continuing Care Center, DAB CR683 (2000).

HCFA determined, with regard to Resident 49, that the provider was not in compliance with the requirement to ensure adequate supervision and assistive devices to prevent accidents. Ms. Buczkowski testified that the records showed a number of instances in which Resident 49 left or attempted to leave the facility unsupervised. Tr. 46.

On September 3, 1997, Resident 49 was missing from the facility at 7:00 a.m. No alarm had sounded. One-half hour earlier, at 6:30 a.m., he had been found in the facility lobby, having gotten out of bed, and he was redirected back to his bed. At 7:45 [a.m.], a local hospital called the provider, indicating that Resident 49 had been picked up on Fairbanks Avenue by ambulance, after he had been found by the police. Tr. 46, 492. HCFA Ex. 18 at 42 - 43. He stayed at the hospital overnight for observation. The following discharge summary was dictated by Amador Delamerced, M.D.:

DATE OF ADMISSION: 09/03/97

DATE OF DISCHARGE: 09/04/97

This patient was sent in by Dr. Goldman from Price Hill Nursing Home. He is a 43-year old white male with a long-standing history of anoxic brain injury, dementia, chronic obstructive pulmonary disease, depression, history of substance abuse in the past, organic personality disorder. He was admitted to Franciscan Hospital - Western Hills Campus having apparently been brought in by the police who found him lying on Fairbanks, unable to give any history. He had multiple bruises and abrasions all over the body with dry, bloody nose noted.

He was extensively worked up, including a head CAT scan which did not show any bleed or stroke.

His medications are Haldol, Depakote, Buspar and Cogentin, Bactrim, Valium. He was observed overnight and remained lethargic but with no significant neurologic deficits. He was able to eat without difficulty, was arousable. He did not verbalize any complaints. He was discharged to a nursing home, put on bedrest with restraints to prevent another episode of wandering. He is to rest and recover from his injuries. He will receive local wound care including Polysporin Ointment to the abrasions on the face and the body. He will resume his previous medications at the nursing home. These include Haldol, Cogentin, Buspar, Depakote.

Dr. Philip Goldman will follow the patient at the Price Hill Nursing Home.

HCFA Ex. 18 at 13.

Sutures were required for a laceration at the tip of Resident 49's right ear and across his nose, which was fractured. His arms and legs were severely bruised. On September 4, 1997, Resident 49 was readmitted to the provider's facility. His skin assessment documented in the provider's nurses' notes showed multiple bruises and abrasions. He had bruises on his right shoulder, both elbows, both hands and knuckles, left hip, both knees, left side of his face, bridge of his nose, and chin. He had abrasions on the knuckles, knees, and chin. The source of his injuries remains unknown. Id. at 16 - 17, 42 - 44; Tr. 49 - 50. He may have fallen, as the provider postulates. His injuries were consistent with a fall.

On September 3, 1997, when the provider staff found that Resident 49 was not in the facility and the alarm had not sounded, they called the company that had installed their audible alarm system that day. The brand name of their system was not actually "WanderGuard," but Cotag (for the bracelets) and Doorgard (for the keypads, placed at exit doors). The company assessed the whole system the same day, September 3, 1997, and found a malfunctioning key pad, which they replaced, that day. Tr. 486 - 489; P. Ex. 13.

The provider supplied the surveyors with the invoice showing the work done on September 3, 1997. Tr. 490, 512 - 513, 518. The keypad had not actually failed, but was "by-passing," by discontinuing the alarm as soon as the exit door closed. Thus, the alarm was sounding only momentarily. The by-pass feature was removed totally, so that the alarm would no longer be discontinued prematurely. Tr. 490.

The surveyors apparently did not have the written Cotag wrist tag information. P. Ex. 13, at 1- 2; HCFA Br. at 5. The Cotag information was given to the provider when it purchased the whole system [the audible alarm system]. Tr. 582. The surveyors may also not have had the Doorgard keypad information. Tr. 414 - 415, 553 - 561; P. Ex. 13 at 3 - 8. Nevertheless, those written materials, together with the testimony of Rhonda Sims, whom I found to be very credible, persuade me that only the provider's keypad was faulty, not any of the provider's audible alarm bracelets (wrist tags). Tr. 486 - 488. Ms. Sims' testimony was corroborated by the testimony of Sondra Dee Schoemaker. Tr. 587 - 590.

At the time of the hearing, Ms. Schoemaker, a licensed practical nurse, had been employed at the provider's facility for 11 years. Ms. Schoemaker testified (on surrebuttal) that the first two pages of Exhibit 13 [the Cotag pages] had been offered to the surveyors during the survey. She testified that the provider had had that information "at the beginning, when our [audible alarm] system was placed." Tr. 587 - 588. In response to direct examination, Ms. Schoemaker testified:

Q Was there, in your opinion, a problem with Resident 49's wrist tag?

A No.

Q Why not?

A Cause it was very functional, worked very well on alarming.

Tr. 589.

Ms. Schoemaker described the gathering in the main nursing office during the survey. The provider staff that she identified as being present were Ms. Sims, Ms. Kersey, and herself. The surveyors she identified as being present were Patty [Patricia Buczkowski] and Ms. Thompson. In response to the question, "What was the discussion about?" Ms. Schoemaker replied, "Well, I know that we were trying to argue our case against the citation under Resident 52, at the time, and Resident [49]. . . . So, we were trying to discuss and argue out our points on that case." When asked, "What was the primary discussion about?" Ms. Schoemaker replied, "52." And then, at some point there became an issue about the alarm system?" Ms. Schoemaker replied, "Yes, the issue about the monitoring, the system we had put in place for monitoring on the alarms. We did not necessarily have a documented out system that they were looking for to address that." Tr. 589 - 590.

The surveyors acknowledged the repair of the key pad, with the following entry on the Statement of Deficiencies:

Interview with facility administrative staff on 9/25/97 at 1:50 PM verified the incident on 9/3/97 was unwitnessed and it was assumed the audible alarm system had not worked. A problem was identified with the audible movement alarm system after the 9/3/97 incident. The system could be bypassed (deactivated) and the alarm would only sound when the resident was within three feet of the key pad. Farther than three feet away, the alarm would not sound so if the resident was already outside and in the yard, the alarm system would not activate the alarm.

HCFA Ex. 3 at 14.

It is unclear to me whether the surveyors understood that the key pad was repaired on September 3, 1997.

The surveyors wrote the following in the Statement of Deficiencies:

Although the facility had a system in place for assuring each of the alarmed doors was operational it did not have a system in place to monitor that each resident's bracelet was functional and the batteries were operational. There was no evidence the facility explored any other type of system breakdown other than the key pad device.

HCFA Ex. 3 at 15.

The evidence shows that the provider acted promptly and effectively to determine why the system failed on September 3, 1997 and to get the system repaired that day. The provider had had the system about 15 months prior to the October 1997 survey. Tr. 537.

In July 1996, documentation regarding Resident 49's behavior included the following Reason for Care Plan Decision:

Resident wanders oof [out of facility] frequently & has many dx [diagnoses] that contribute to cognitive deficits. Plan to proceed to care plan to monitor behavior & intervene as necessary. New wanderguard system has allowed staff to monitor wandering oof more efficiently.

P. Ex. 8 at 136.

I find that the provider's audible alarm system was only one of at least nine different methods and approaches the provider used to prevent Resident 49 from leaving the facility without supervision. Tr. 422 - 427; HCFA Ex. 18 at 60 - 64. The provider and the treating psychiatrists worked to minimize Resident 49's anxiety and agitation while avoiding lethargy. There were frequent psychiatric consults in an attempt to balance his medications. Restraints were contraindicated and none were applied. The provider sought to improve any conditions, such as his impaired cognitive status, his unsteady gait, and his urinary tract infection, which could interfere with Resident 49 attaining his highest practicable physical, mental, and psychosocial well-being. The interventions for such problems would be expected also to help keep him from trying to leave the facility. The provider staff frequently checked Resident 49. The provider's care plan for Resident 49 could be described as holistic and compassionate and effective. It is obvious that the provider and Resident 49's psychiatrists had the objective of keeping Resident 49 as fully functioning as possible while keeping him safe.

In mid-September 1997, Resident 49 was found to have a "sub therapeutic valproic acid level," demonstrating the difficulty in balancing his medications. P. Ex. 8 at 9. Following the October 1997 survey, the provider staff attempted to find placement for Resident 49 in a locked facility, as shown by documentation dated October 28, 1997 and November 3, 1997. Resident 49's sister was contacted relative to a possible "lock unit." Two nursing facilities in the area assessed the resident, but were unable to take him due to being unable to provide more monitoring than he was receiving at the provider's facility. The licensed social worker also tried to find alternative placement for Resident 49, but was unable to locate placement that would provide better security monitoring than the provider's current system. HCFA Ex. 18 at 82 - 83; Tr. 455 - 456.

In about March 1998, Resident 49 broke out a bathroom window to climb out of the provider's facility. Based on that behavior, treating psychiatrist Dr. Massoud determined to place Resident 49 in a lock unit in a Veterans facility and discharge him from the provider's facility. Tr. 532 - 534, 589 - 590. The relevance of that information is that it confirms how very difficult it was to provide care and services to Resident 49.

The provider worked diligently with the hope of modifying Resident 49's behavior so that he might continue to reside in the provider's facility. The provider took numerous precautions to prevent Resident 49 from leaving the facility unwitnessed. Many, many of Resident 49's repeated attempts to leave the facility were stopped by provider staff. The surveyors documented that Resident 49 attempted to leave the facility on about 30 different days within a six-week period, including multiple times on some of those days.

The evidence shows that Resident 49 left the facility grounds without the provider's knowledge on only two or three of those occasions, including August 25, 1997 and September 3, 1997. HCFA Br. at 1-5; HCFA Ex. 5 at 43 - 45; HCFA Ex. 9 at 1 - 5; HCFA Ex. 18; Tr. 93 - 97, 102 - 112; and P. Br. at 5.

I find that the evidence does not prove that the audible alarm system failed to sound previous to September 3, 1997. I find no evidence that the audible alarm system failed to work on any day other than September 3, 1997. Resident 49 left the facility grounds undetected on August 25, 1997. It is possible that the audible alarm system did not sound then, but I cannot draw that inference from the evidence. The evidence does not persuade me that the key pad was malfunctioning prior to September 3, 1997, or that any other component of the audible alarm system malfunctioned. Nevertheless, on August 25, 1997, the provider was on notice that it needed to take additional action to prevent Resident 49's unwitnessed departures. Consequently, the finding of a deficiency on September 3, 1997, when Resident 49 again left the facility grounds undetected, is appropriate. I find that because the provider took immediate action that day to rectify the malfunction, the audible alarm system was working properly later in the day on September 3, 1997. Tr. 489 - 490.

The surveyors based the deficiency largely on their finding that the provider did not have a system in place to monitor or test the operation of each resident's alarm bracelet, or wrist tag. For 20 days, September 4, 1997 through September 23, 1997, until the provider had such a system in place, the surveyors found immediate jeopardy to persist. The surveyors relied on WanderGuard manufacturer's instructions, which call for daily testing. HCFA Ex. 39. As we have seen, the provider was not using WanderGuard equipment.

The evidence shows that the Cotag audible alarm bracelets had long-life power cells and were self-monitoring, with an audible beep when the voltage became low. The wrist tag (transponder) could be strapped to the wrist or the ankle. Its 3V (volt) lithium power cell, or battery, had a typical seven-year life. Even if the wearer (wanderer) remained in the field (within range of the keypad) for prolonged periods, the power cell life was typically 3 years. P. Ex. 13 at 1. If the battery were to go low, a battery flag (audible beep) provided a warning. Id.; Tr. 487. The provider staff also knew the exit components of the alarm system were working because the alarm sounded routinely. Tr. 488, 589. I conclude that the provider has proved that, for 20 days, September 4, 1997 through September 23, 1997, it was in substantial compliance with the only requirement alleged to be deficient at an immediate jeopardy level, Tag F-324, a quality of care requirement concerning accidents pursuant to 42 C.F.R. § 483.25(h)(2). Since there was no deficiency under 42 C.F.R. § 483.25(h)(2) [Tag F-324], there was no immediate jeopardy.

There is no evidence that any resident's alarm bracelet ever malfunctioned. Consequently, I find HCFA's determination that immediate jeopardy persisted for the 20 days from September 4, 1997 through September 23, 1997, to be clearly erroneous.

"Immediate jeopardy means 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." 42 C.F.R. § 488.301. [italics in original].

Since no resident suffered serious injury, harm, impairment, or death, from September 4, 1997 through September 23, 1997, the issue is whether it was likely that a resident would suffer serious injury, harm, impairment, or death.

Even when two residents, Resident 49 and Resident 52, were still examples of the deficiency under Tag F-324, various State survey agency employees differed as to whether the situation constituted immediate jeopardy. Accordingly, the deficiency was initially cited at a scope and severity level of "G" (not immediate jeopardy). Before the Statement of Deficiencies was completed, however, the scope and severity level was changed to "J" (immediate jeopardy). When Resident 52's situation was eliminated from consideration during the informal dispute resolution, the scope and severity for Tag F-324 still remained at a J level.

The State Operations Manual (SOM), at Appendix Q, gives guidance to surveyors as follows:

"[i]mmediate and serious threat" [means] having a high probability that serious harm or injury could occur at any time, or has already occurred, and may well occur again if [residents] are not protected effectively from the harm, or the threat is not removed.

I find that it was not likely, and there was not a high probability, that any resident would suffer serious injury, harm, impairment, or death, from the provider's failure until September 23, 1997 (actually, until September 26, 1997) to have a system for testing in place. There is no evidence to prove that any of the provider's five residents who wore the wrist bracelets remained at risk for serious injury, once the key pad was repaired. There is no evidence that any bracelet ever malfunctioned or was likely to malfunction.

The surveyors articulated that each wrist bracelet was required to be tested periodically, relying on the WanderGuard manufacturer's guidance. In response to the survey and the Statement of Deficiencies, the provider started testing each resident's wrist bracelet periodically and had in-service training, which is excellent preventive maintenance, even though the facility was not using a WanderGuard product.

The surveyors' conclusion that the five residents were at risk of serious harm until such preventive precautions were in place is clearly erroneous because it is not likely, and there was not a high probability, that the bracelets, which were operating fine, were going to stop functioning during the period beginning September 4, 1997 and ending September 26, 1997 and contribute to the serious injury, harm, impairment, or death of one of the residents.

I am persuaded that, before I could find that the provider remained deficient in ensuring that each resident received adequate supervision and assistive devices to prevent accidents, I should be able to articulate what act or omission on the part of the provider caused it to fall short of meeting that requirement. I find the provider deficient for failure to keep Resident 49 from exiting the facility unwitnessed on September 3, 1997, between 6:30 a.m. and 7:00 a.m. The deficiency ended, in my view, when Resident 49 was located and adequately cared for, and the audible alarm system was functioning properly. That was also September 3, 1997.

VI. Conclusion

The provider was not in substantial compliance with all Medicare participation requirements during the time covered by the October 1997 survey. HCFA had the authority to impose a CMP. There was immediate jeopardy for one day, September 3, 1997. A $6,950 CMP is reasonable.
JUDGE
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Jill S. Clifton

Administrative Law Judge

 

FOOTNOTES
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1. HCFA contracts with state health agencies to conduct surveys of skilled nursing facilities' compliance with Medicare participation requirements. Sections 1864 and 1819(a) of the Social Security Act; 42 U.S.C. § 1395aa; 42 U.S.C. §1395i-3(g); and 42 C.F.R. § 488.20.

CASE | DECISION | JUDGE | FOOTNOTES