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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:

Century Care of Crystal Coast,

Petitioner,

DATE: August 09, 2006
                                          
             - v -

 

Centers for Medicare & Medicaid Services.

 

Docket No.C-04-528
Decision No. CR1488
DECISION
...TO TOP

DECISION

Century Care of Crystal Coast (Petitioner or facility) is a nursing facility, located in Morehead City, North Carolina, that is certified to participate in the Medicare and Medicaid programs as a provider of services. One of its residents was not properly supervised when she eloped from the facility; a second resident suffered flash burns to his face and hands when he ignited a cigarette lighter while his oxygen was flowing. After reviewing the circumstances surrounding these incidents, as well as other findings, the Centers for Medicare & Medicaid Services (CMS) determined that, from April 26 through July 20, 2004, the facility was not in substantial compliance with program requirements, and that, from April 26 through June 16, 2004, its conditions posed immediate jeopardy to resident health and safety. Petitioner now challenges those determinations.

For the reasons set forth below, I conclude that the facility was not in substantial compliance with program requirements during the period in question, and that, from April 26 through June 16, 2004, the facility's deficiencies posed immediate jeopardy to resident health and safety. I do not consider whether the amount of the civil money penalty (CMP) imposed - $3,050 per day for 52 days and $150 per day for 34 days (total of $163,700) - is reasonable. By law, the minimum per day penalty for periods of immediate jeopardy is $3,050. Petitioner has presented no challenge to the reasonableness of the penalty for the period of substantial noncompliance that did not constitute immediate jeopardy.

Background

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

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may "pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

The Secretary contracts with state survey agencies to conduct periodic surveys to determine whether skilled nursing facilities (SNFs) (Medicare) and nursing facilities (NFs) (Medicaid) are in substantial compliance with program participation requirements. Act, � 1864(a); 42 C.F.R. � 488.20. The regulations require that each facility be surveyed once every twelve months, and more often, if necessary, to ensure that identified deficiencies are corrected. Act, section 1819(g)(2)(A); 42 C.F.R. �� 488.20(a), 488.308.

In this case, the North Carolina Department of Health and Human Services (State Agency) conducted a complaint investigation/survey, which it completed on June 18, 2004. CMS Exs. 2, 3; Tr. 134. The state surveyors concluded that the facility was not in substantial compliance with program requirements, specifically:

    �42 C.F.R. � 483.25(h)(2) (Tag F324 - quality of care - accidents), at scope and severity level "K" (pattern of noncompliance that posed immediate jeopardy to resident health and safety);

    �42 C.F.R. � 483.35(d)(3) (Tag F365 - dietary services - food), at scope and severity level "D" (isolated deficiency that caused no actual harm, with the potential for more than minimal harm);

    �42 C.F.R. � 483.35(e) (Tag F367 - dietary services - therapeutic diets), at scope and severity level "E" (pattern of noncompliance that caused no actual harm with potential for more than minimal harm); and

    �42 C.F.R. � 483.75 (Tag F490 - administration), at scope and severity level "K."

CMS Exs. 2, 3; P Ex. 1. The State Agency subsequently determined that the facility's deficiencies no longer posed immediate jeopardy as of June 17, 2004, and that the facility achieved substantial compliance on July 21, 2004.

Based on the State Agency's findings, CMS has imposed a CMP of $3,050 per day for 52 days of immediate jeopardy (from April 26 through June 16, 2004), plus $150 per day for the 34 days from June 17 through July 20, 2004, when the facility was still not in substantial compliance, but its deficiencies no longer posed immediate jeopardy to resident health and safety. (Total CMP $163,700). (1) CMS Exs. 6, 28, 29. (2)

Petitioner timely requested a hearing.

The hearing convened on March 14, 2006, in New Bern, North Carolina. Mr. Joseph L. Bianculli appeared on behalf of Petitioner, and Ms. Gwendolyn Johnson appeared on behalf of CMS. I admitted CMS Exhibits (CMS Exs.) 1 through 36 and Petitioner's Exhibits (P. Exs.) 1 through 45. Tr. 2-3. CMS subsequently withdrew CMS Ex. 35, so that document is removed from the record. Tr. 118.

Issues

The issues before me are:

1. Whether, from April 26 through July 20, 2004, the facility was in substantial compliance with program participation requirements, specifically, 42 C.F.R. � 483.25 (h)(2) (quality of care - accidents), 42 C.F.R. � 483.35 (dietary services), and 42 C.F.R. � 483.75 (administration);

and

2. If the facility was not in substantial compliance from April 26 through June 16, 2004, did its conditions then pose immediate jeopardy to resident health and safety.

With respect to the amount of the penalty imposed, if I find immediate jeopardy from April 26 through June 16, 2004, I must sustain the $3,050 per day CMP, because that is the statutory and regulatory minimum for deficiencies that pose immediate jeopardy. Aside from arguing its substantial compliance, Petitioner has not challenged the CMP amount ($150 per day) for the period June 17 through July 20, 2004.

Discussion


  I. From April 26, through July 20, 2004, the facility was not in substantial compliance with the program participation requirements. (3)

A. The facility did not provide an adequate level of supervision to prevent accidents, as required by 42 C.F.R. � 483.25(h)(2).

Few facts are in dispute here. The parties agree that on April 26, 2004, one of the facility's residents, referred to as Resident # 10 (R10), was not properly supervised when she wandered away from the facility grounds. Staff from an adjacent office building noticed her sitting behind their building and she was eventually returned to the facility unharmed. Facility staff did not document R10's departure nor inform the facility's administrative staff of the event. The parties also agree that on May 5, 2004, a second facility resident, Resident # 2 (R2), suffered flash burns to his face and hands after he lit a contraband cigarette lighter in the presence of his flowing oxygen.

I consider first whether these incidents establish that the facility was not in substantial compliance with 42 C.F.R. � 483.25(h)(2). Under the statute and the "quality of care" regulation, each resident must receive, and the facility must provide, the necessary care and services to allow a resident to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, � 1819(b); 42 C.F.R. � 483.25. Among other specific requirements, the facility must "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)(2); Windsor Health Care Center, DAB No. 1902, at 5 (2003); Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester Pavilion, DAB No. 1750, at 25-26 (2000); Woodstock Care Center, DAB No. 1726, at 25 (2000). The facility must anticipate potential accidents and take steps to prevent them (increased supervision or the use of assistance devices). Guardian Health Care Center, DAB No. 1943, at 18 (2004).

A facility is permitted the flexibility to choose the methods it uses to prevent accidents, but the chosen methods must constitute an "adequate" level of supervision under all the circumstances.

Windsor Health Care Center, DAB No. 1902, at 5. See also, Windsor Health Care Center, DAB No. 1902, at 16-17; Woodstock, DAB No. 1726, at 25-30. (Section 483.25(h)(2) imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." )

Resident #10.

Petitioner acknowledges the inadequacy of its supervision, at least with regard to R10. See, e.g., Tr. 46 ("I will reiterate that we are not contesting that it will be appropriate to find that there was a deficiency relating with the supervision of this resident. The resident obviously was not supervised." ); P. Closing Br. at 3, 20, 24. R10 was a long-time facility resident who suffered from organic brain syndrome and depression, and whose memory was deteriorating. P. Ex. 43, at 3. She had a history of wandering and elopement, which the facility acknowledged. She wore an electronic alarm bracelet that sounded a loud alarm if she approached an exterior door. P. Ex. 25, at 7, 8; P. Ex. 26; P. Ex. 45, at 4 (Wolf Decl.); P. Ex. 43, at 3 (Piner Decl.); Tr. 50.

R10 was also a very heavy smoker. "[S]he smoked almost constantly." P. Ex. 45, at 4 (Wolf Decl.); P. Ex. 43, at 3 (Piner Decl.). Because of her deteriorating mental condition, she was considered an "unsafe smoker" who required supervision at all times when smoking. P. Ex. 43, at 3 (Piner Decl.); Tr. 55.

Prior to April 2003, residents, including R10, were allowed to smoke in the facility's dining room. The facility then instituted a smoke-free policy, and residents were supposedly allowed to smoke only on an adjacent patio. Tr. 34. (4) But the facility did not seem to enforce a consistent policy on resident smoking. It had in place a written policy, dated February 27, 2002, updated in February 2003, when the facility announced that its building would become smoke-free. According to the written policy,

each resident who smokes will not be permitted at any time to keep lighters, matches and cigarettes in his or her room or on his or her person. Lighters, matches will be stored at the nurse's station, the front office, the activity office, and Social Services Office.

CMS Ex. 25, at 9; P. Ex. 29, at 2; Tr. 76-77; see also, P. Ex. 30. Notwithstanding the written policy, the facility administrator, Beverly Jorgenson, testified that residents were allowed to keep cigarettes with them. Her testimony with respect to the policy on lighters and matches was inconsistent. She said in her declaration that lighters and matches were to be kept at the nursing station, and residents were permitted to smoke only in an outdoor smoking area outside the dining room. P. Ex. 42, at 2 (Jorgenson Decl.). Under cross- examination, however, she modified her claim and said that "safe" residents were allowed to carry lighters during the day, and then turn them in at night. Tr. 127. Consistent with this testimony, the surveyors learned that, notwithstanding the written policy, some residents kept lighters, matches and cigarettes, with the staff's knowledge and consent. Tr. 77.

In any event, R10 was plainly not a "safe" smoker. By the time of her elopement, smoking in the building had not been allowed for two years, but her habits were apparently well-ingrained; she continued to smoke in the dining room from time to time, and to smoke unsupervised. She had also been caught multiple times with matches or a lighter in her possession, and was occasionally even caught smoking two cigarettes at the same time. P. Ex. 27, at 1; P. Ex. 28, at 1, 3, 4, 6; CMS Ex. 3, at 10; CMS Ex. 13, at 28, 29, 30 ("Pt. remains noncompliant [with] smoking policy and continues to smoke on patio [without] supervision."), 31, 32 ; Tr. 34-35; Tr. 54.

R10 was "constantly was going out to the patio behind the dining room to smoke at all hours and in all weather conditions." P. Ex. 45, at 4 (Wolf Decl.); P. Ex. 43, at 3-4 (Piner Decl.). She always headed for the same door, and continually triggered that door's alarm. Tr. 43, 51. In fact, the staff became inured to her constant departures, telling the surveyors that, although they were supposed to go out with R10 when she went to the patio, she went there by herself at times. Tr. 42. Nursing notes dated December 12, 2003, at 6:30 p.m. document that she "continues to go out on the patio to smoke without supervision." CMS Ex. 3, at 9-10. A note dated December 13, 2003, at 7:00 p.m. documents that she "continues with noncompliance with smoking policy and goes out on patio without supervision." A social service progress note dated December 18, 2003, states that she "frequently goes out the back door alone." P. Ex. 28, at 7. She would exit the facility and the alarm would sound, but staff would not respond, saying instead, "Oh, that's Resident Number Ten. She's going out to the patio." Tr. 37.

April 26, 2004 incident. Although the record is spotty as to the exact circumstances surrounding R10's elopement, (5) employees from a physician's office in a building adjacent to the facility reported that, through an office window, they observed R10 sitting at an outside picnic table. Initially, they did not know where she was from, since people from a near-by senior center would sometimes sit at that table. Tr. 41. But they checked her wrist band and determined that she was a facility resident. They took her into the office and called the facility. Facility staff walked over and picked her up, and returned her to the facility, unharmed. P. Exs. 34, 35.

To get to that picnic table, R10 apparently walked through a gate in the chain-link fence that surrounded the patio. She walked through a line of trees, past a parking lot, and around to the back of the building that housed the physician's office. Tr. 38-40; P Ex. 42, at 4-5 (Jorgenson Decl.). According to Surveyor Ernie Zapetis, the patio gate was not locked, and its clasp could easily be undone. Tr. 52. Administrator Jorgenson, on the other hand, opined that R10 would not have been able to unlatch the gate herself, and guessed that a "newly hired temporary maintenance man" probably left the gate unlatched. P. Ex. 42, at 5 (Jorgenson Decl.); see also P. Ex. 45, at 4 (Wolf Decl.). Since the facility did not investigate, there is no way to know how R10 was able to leave the patio.

No documentation, no report, no investigation. The facility conducted no investigation following R10's elopement. Staff explained to the surveyors that the administrator and the Director of Nursing (DON) were away from the facility at a conference, so the Assistant Director of Nursing (ADON) picked up the resident and "they just didn't think about conveying that information to the DON or the Administrator, and they didn't document it anywhere, and they didn't do anything else about it." Tr. 47-48. In fact, the facility administration first learned of the incident from the surveyors.

Subsequent events. Subsequent smoking incidents involved R10. A May 5, 2004, 6:00 p.m. nursing note indicates that she was again found smoking in the dining room. She had a cigarette lighter in her pocketbook. P. Ex. 27, at 2; CMS Ex. 13, at 27. Later that night she was found alone, smoking on the patio. She had a book of matches. She was later found smoking two cigarettes in the dining room. She again had a book of matches. P. Ex. 27, at 3; CMS Ex. 13, at 26.

Resident #2

R10 was not the only facility resident suffering from dementia who violated the facility's smoking policies and who possessed a contraband cigarette lighter or matches.

Resident #2 (R2) was admitted to the facility in January 2004, (6) with diagnoses of mild dementia, delirium, chronic obstructive pulmonary disease, and acute pneumonia. He required oxygen almost continuously. He was also a heavy smoker, and removed his oxygen in order to go outside to smoke. But, without his oxygen, he frequently exhibited confusion and disorientation. P. Ex. 8, at 2; P. Ex. 9, at 1, 2; P. Ex. 10; P. Ex. 43, at 2 (Piner Decl.); Ex. 45, at 2 (Wolf Decl.).

According to Director Wolf, the facility routinely advised its new admissions of the facility rules regarding smoking (although she did not specify which of its conflicting rules were explained). In her declaration, Director Wolf testified that she spoke to R2 about the facility's rules regarding smoking, and that he "definitely" understood those rules, and was capable of following them. P. Ex. 45, at 2 (Wolf Decl.) Under cross-examination, she admitted that she did not actually remember R2's admission, but said that it was standard practice to explain the smoking policy to every new admission. Tr. 17. She did not even know whether R2 was present, or whether the policies were explained to a family member. Tr. 18. Similarly, Administrator Jorgenson asserts that "as with the other residents, facility staff explained the policy to R2 at the time of his admission, and he agreed to comply." P. Ex. 42, at 2 (Jorgenson Decl.). However, she does not specify which of the conflicting policies staff explained, and I see no evidence that Administrator Jorgenson had any more direct knowledge of R2's admissions process than Director Wolf. Indeed, she likely knew even less.

On February 9, 2004, staff reported smelling cigarette smoke in R2's bathroom, suggesting that he had violated the facility smoking policies. Director Wolf asked him whether he had been smoking, and, after initially denying it, he admitted that he had done so, and promised not to do it again. P. Ex. 12; P. Ex. 45, at 2 (Wolf Decl.); CMS Ex. 8, at 8; Tr. 20. No one asked R2 how he managed to light the cigarette(s); no one asked him whether he had matches or a lighter: (7)

JUDGE HUGHES: The first time he smoked in his room, and you were aware that he smoked in his room, how did he light the cigarette?

THE WITNESS: I don't know. I assume he had - -

JUDGE HUGHES: Did you ask him?

THE WITNESS: No, I didn't ask him.

JUDGE HUGHES: So, you did not investigate to see whether or not he had matches or a lighter in his room?

THE WITNESS: I didn't search his things, no.

JUDGE HUGHES: You didn't have to search his things to ask him a question. It wouldn't have been a violation of his rights to ask him a question.

THE WITNESS: Right.

JUDGE HUGHES: Would it have been a violation of his rights to let his visitors know that it was very important that they not provide him with a lighter or matches?

THE WITNESS: No, that wouldn't have been a violation.

JUDGE HUGHES: And you didn't do that, either?

THE WITNESS: No.

Tr. 25.

Notwithstanding this definitive testimony, Petitioner asserts that, following the February 9 smoking incident, Director Wolf asked R2 whether he had a lighter in his room. P. Reply Br. at 11. To support this claim, Petitioner relies on earlier, more equivocal testimony from Director Wolf. After she admitted that she did not know how R2 lit his cigarettes, CMS counsel asked, "after you counseled him the first and second time, did you think to ask him whether or not he might have a lighter or matches, or have access to them?" Director Wolf replied, "Well, we talked about the fact that he was not allowed to have them, and he assured me that he didn't." Tr. 19; see P. Reply Br at 11-12, fn 9. This suggests a conversation sometime after the second incident. Moreover, Petitioner omits Director Wolf's next response:

Q. He told you he did not have lighters or matches on his person?

A. Right.

Q. Or did he tell you that he wasn't smoking in his room?

A. Well, he told me initially that he wasn't smoking in his room. And then he later - - after I talked to him for a few minutes, he said, "Yeah, all right, I did, but I won't do it anymore."

Tr. 19-20. Because I found this testimony confusing, I asked the more specific questions, and Director Wolf admitted that, following the first incident of R2 smoking in his room, she did not ask how he lit the cigarette or whether he possessed a lighter or matches, much less how he could have obtained them. See Tr. 25. Certainly, Director Wolf, as well as Petitioner's other witnesses, had ample opportunity to specify what steps they took, immediately following the February 9 smoking incident, to prevent R2 from again smoking in his room. And the evidence establishes that they did very little.

Several days later, on February 13, 2004, another staff member reported smelling cigarette smoke in R2's bathroom. When Director Wolf questioned him, R2 denied smoking indoors. Noting that R2's hygiene "was not very good," and that his clothes frequently reeked of smoke because they "had not been laundered for some time," Director Wolf claimed that she "was satisfied" with R2's denial, and saw no need or justification for further action. She did "not see any way" to justify searching R2's possessions or otherwise limiting his right to smoke. P. Ex. 12; CMS Ex. 8, at 8; P. Ex. 45, at 2 (Wolf Decl.)

R2 also seems to have done a fair amount of his smoking on the front porch rather than on the patio behind the dining room, even though, according to the facility policy, the front porch was not a designated smoking area. P. Ex. 19, at 6, 8, 9, 12; P. Ex. 30; Tr. 126-127. According to the written policy and Administrator Jorgenson, residents were allowed to smoke "only" in the patio area outside the dining room. P. Ex. 30; P. Ex. 42, at 2 (Jorgenson Decl.). But staff, including Administrator Jorgenson, were obviously aware that R2 smoked on the front porch, and I see no suggestion that they considered this a problem. See, e.g. P. Ex. 19, at 12 (Per Administrator Jorgenson: "There have been two occasions that I have seen [R2] smoking on the facility front porch.").

May 5, 2004 incident. In the early morning hours of May 5, 2004, R2 got out of bed, and, apparently forgetting that his oxygen was flowing, he lit a cigarette lighter, igniting the oxygen nasal cannula, and suffered flash burns to the left side of his face and to his hands. P. Ex. 13, at 1; P. Ex. 15. At the hospital emergency room, he was diagnosed with first degree burns on the left side of his face and on both hands, and was prescribed Percocet for the pain, and antibiotic ointment to prevent infection. P. Ex. 15. (8)

Initially, R2 told the nurse that he did not know why he did it, "I just did." P. Ex. 13, at 1; CMS Ex. 8, at 5. He later told Director Wolf that he had wanted to call his wife, and "popped the lighter up" near his face to read her phone number, which was on a business card. P. Ex. 16; CMS Ex. 43, at 3. He denied smoking, although he admitted having in his room a cigarette lighter, which he said a visitor had given him. P. Ex. 45, at 3 (Wolf Decl.). Staff subsequently found a lighter and two cigarettes in his room, and a cigarette butt on the floor near the bathroom door. P. Ex. 13, at 2; CMS Ex. 8, at 12. The cigarettes and lighter were confiscated. CMS Ex. 8, at 5-6.

Petitioner nevertheless claims that "there is no evidence" that R2 was actually smoking or attempting to smoke at the time of his accident. P. Closing Br. at 14. I consider the staff's finding cigarettes, a lighter, and, most significant, a cigarette butt on the floor (9) "evidence" of smoking. However, I need not resolve that question in order to determine whether R2 was properly supervised to prevent accidents.

Analysis. CMS argues that the facility failed to provide adequate supervision to its residents, particularly to its smokers. I agree.

1. The facility had in place an ambiguous smoking policy, inconsistently applied.

Under the written policy, no resident was allowed to keep cigarettes, lighters, or matches in his room or on his person. CMS Ex. 25, at 9; P. Ex. 29, at 2; P. Ex. 30. But, in practice, all residents who smoked were allowed to keep cigarettes with them. P. Ex. 42, at 2. And, according to Administrator Jorgenson, in practice, residents deemed "safe" were allowed to carry their own lighters during daytime hours. Tr. 127, 77. (10) The written policy limited smoking to the back patio. In practice, R2 regularly smoked on the front porch. While it may have been perfectly appropriate to allow smoking on the front porch, this should have been reflected in the facility's written policy.

2. The facility had in place no systematic procedure for assessing the degree of supervision required for its smokers.

According to the written policy, "[e]ach resident who smokes shall be provided the degree of independence appropriate to his/her demonstrated ability to do so safely and within facility guidelines." P. Ex. 29, at 2. But, prior to the June 2004 survey, the facility had no systematic approach for assessing that "appropriate degree of independence." Petitioner concedes that, at the time of R2's admission, the facility performed no written assessments as to a resident's ability to smoke unsupervised. Nor did the facility develop care plans to insure a resident's safety while smoking. P. Closing Br. at 10.

Still, the smoking issue was not completely ignored, according to Nurse Piner, who testified that, around the time of R2's admission, she determined that smoking safety was not an issue for him because he was alert and oriented. Tr. 124. Indeed, Nurse Piner testified that, up until the day he burned himself, she saw no need to change R2's care plan with respect to safety issues. Tr. 124. I find this remarkable. First, R2's history was significant for confusion, delirium, and unsafe behaviors, including unsafe smoking behaviors. He was suffering from progressive dementia. He was visually impaired. See, CMS Ex. 8, at 54-59. Immediately before his admission to the facility, he had been hospitalized with a "worsening mental status." He had been waking in the middle of the night, turning on the stove and faucets, and leaving them on. His wife reported that he "drop[ped] cigarette butts in the home and she [was] concerned that he [would] burn the house down." CMS. Ex. 8, at 57. Second, as the facility recognized, R2 had to remove his oxygen in order to smoke with any degree of safety, but, without his oxygen, he became confused and disoriented. Third, Nurse Piner testified that, near the time of his admission, she discussed the oxygen safety policies with him, and was "satisfied that he had the capacity to understand the danger." Tr. 123; see P. Ex. 8, at 2. Yet, soon after this discussion, he violated those policies by smoking in his room, exposing himself and others to significant danger, and neither Nurse Piner nor anyone else re-assessed the risk he posed. (11) Tr. 125. Even if it had been reasonable to deem R2 a "safe" smoker at the time of his admission (which I find unconvincing), it was not reasonable to consider him a "safe" smoker after he violated the facility's oxygen safety policies by smoking in his room. Tr. 125.

3. The facility's response to R2's February 9, 2004 smoking incident was not adequate for preventing accidents.

R2 was on continuous oxygen; he had been told how dangerous it was for him to smoke in his room, and he did it anyway. This was a very serious matter. I am therefore not persuaded by Petitioner's suggestion that R2's smoking in his room was "not serious enough to demand that the resident consent to involuntary searches, (12) to restrict his visitors, or to consider discharge." P. Closing Br. at 17; P. Ex. 42, at 3 (Jorgenson decl.).

Moreover, even if these methods were deemed too intrusive, the facility could have intervened in other, more benign ways. Obviously, R2 had a means by which to light his cigarettes, but Director Wolf did not even ask him how he had done so. She did not ask him to turn in his lighter. Nor did the facility advise his visitors that it was very important that they not provide him with a lighter or matches. Tr. 25. The facility might also have considered installing smoke detectors in R2's room and/or bathroom. There is no evidence that the facility increased its supervision of R2. Indeed, according to Nurse Piner, he was still considered a "safe smoker." As noted above, the facility has flexibility to choose the methods by which it prevents accidents, but those methods must be adequate. Here, though presented with unmistakable evidence that R2's actions posed significant risk of accidents, the facility failed to take even minimal steps to prevent them.

4. The evidence establishes that even a seriously demented resident could obtain cigarettes, lighters, and matches, yet the facility took virtually no action to prevent this.

As discussed above, the facility understood that R10 could not safely possess lighters and matches, but she repeatedly managed to obtain them. P. Ex. 27, at 1-3; P. Ex. 28, at 1, 3, 4, 6; CMS Ex. 3, at 10; CMS Ex. 13, at 26-32; Tr. 34-35; Tr. 54. Also as discussed above, R2 seems to have had little difficulty in obtaining a lighter.

The surveyors spoke to staff, who suggested that the residents who were allowed to possess fire materials and cigarettes would share them with other residents without regard to safety levels. Tr. 60, 71. Petitioner complains about the reliability of the surveyor findings, but I need not even reach that issue. The uncontroverted evidence establishes that facility staff knew or should have known that the facility's smokers - even a high risk smoker like R10 - were able to obtain lighters and matches. The facility was therefore charged with investigating how the items were obtained, and taking steps to stop it from happening again. Yet, it offers no evidence that it undertook any investigation or other effort to prevent residents from acquiring these dangerous items. The facility's inaction falls far short of taking reasonable steps to mitigate foreseeable risks of harm from accidents.

5. As the facility concedes, it failed to provide R10 an adequate level of supervision to prevent accidents.

With respect to R10's elopement, staff simply reneged on their obligation to supervise her. Her care plan called for close supervision. She was not supposed to be on the patio unsupervised. She was not supposed to be smoking unsupervised. Tr. 55. Yet she left the building, left the facility grounds, made her way to the building next door, and no one at the facility even realized she was missing until they were called by the people who found her.

Without any support, Petitioner asserts that R10 was "immediately" spotted sitting at the picnic table, that the facility neighbors "immediately" called the facility, and that facility staff "immediately" picked her up, concluding that R10 was gone "no more than five minutes." P. Closing Br. at 24. This is pure fantasy. The facility did not document. The facility did not investigate. No one has any idea how long R10 was gone. She could have been gone for a substantial amount of time. And even if she had been missing for a relatively short time, the facility's failure to supervise still put her at significant risk. That she was discovered by responsible neighbors and returned to the facility unharmed was certainly fortuitous, but, as I have noted in similar circumstances, "critical to preventing accidents is a facility's recognition that a wandering resident might elope, and that a frail and confused resident is at increased risk when outside the facility without supervision." Medina Nursing Center, DAB CR1469, at 9 (2006); Lake Park Nursing and Rehabilitation Center, DAB CR1341, at 12 (2005); see also 42 C.F.R. � 488.301 (facility is not in substantial compliance if its deficiencies pose the potential for more than minimal harm). Here, R10 would have been at risk if she had remained unsupervised on the smoking patio. That she managed to leave the facility grounds and wander around only increased her vulnerability.

Pointing out that staff regularly checked her alarm bracelet, which was functioning properly, Petitioner also suggests that some unidentified visiting relative abandoned R10 alone on the patio. (13) Again, not one shred of evidence - no note in the file, no statement from a facility employee - suggests that R10 had a visitor. That her alarm was working only suggests that she probably set it off when she left the building unsupervised, as she had on so many other occasions. And staff simply ignored the alarm and allowed her to go out to the patio alone.

Because the facility did not adequately supervise R10, placing her at significant risk of suffering an accident and potentially serious injury, it was not in substantial compliance with 42 C.F.R. � 483.25(h)(2).

6. Facility staff failed to document, report, or investigate R10's elopement.

Compounding its deficiencies, facility staff neither documented, reported, nor investigated R10's elopement. Administrator Jorgenson, the DON, and other administrative staff first learned of the incident from the surveyors. P. Ex. 45, at 5 (Wolf Decl.) To this day, Administrator Jorgenson is "not entirely sure of what happened because no nurse reported the incident to me or the Director of Nursing (or to the Resident's attending physician or family) at the time." P. Ex. 42, at 6 (Jorgenson Decl.); Tr. 134.

Petitioner acknowledges that the matter "should have been reported and investigated at the time," but then attempts to justify the staff's inaction by arguing, somewhat inconsistently, that: 1) the elopement was an isolated event; and 2) the elopement was consistent with R10's usual state, "not the result of any change in the Resident's condition, unusual agitation, increased propensity to wander, etc." P. Ex. 42, at 6 (Jorgenson Decl.); P. Ex. 45, at 5 (Wolf Decl.); P. Ex. 43, at 5 (Piner Decl.). According to Petitioner, no evidence establishes that R10's elopement

showed some evolution of the Resident's focused wandering behavior to some more dangerous activity such as aimless wandering, or exit-seeking behavior focused on, or posing the risk of escaping the Center's grounds.

P. Closing Br. at 38.

I do not understand how staff could have made such an ad hoc determination without any investigation. R10 may have regularly left the facility building to smoke unsupervised on the patio, but she had purportedly never before left the facility grounds. That she left the grounds represents an obvious change. On the other hand, if Petitioner is correct that R10's actions were consistent with her prior behavior, then she had long been engaging in dangerous behaviors, and the facility's interventions were not keeping her in a safe place. This elopement, along with her other "consistent" behaviors, should have been reported and investigated so that the facility professionals could determine what changes were necessary to keep her safe.

Without an investigation to determine how and why the elopement happened, the facility is not in a position to take steps to prevent it from recurring. For example, R10 was plainly able to exit through the gate in the chain-link fence surrounding the patio, something she had apparently never done before. The surveyors opined that the gate latch was easily opened. Administrator Jorgenson opined, on the other hand, that R10 would not have been capable of opening the latch, and blamed maintenance personnel for leaving the gate open. Because no one investigated, we have no way of knowing. But, if an investigation revealed that R10 was capable of unlatching the gate, facility efforts to prevent recurrence might be different than if the maintenance personnel left the gate unlatched.

By failing to report and investigate the incident, the facility was not taking reasonable steps to mitigate the foreseeable risks of harm from accidents. (14)

B. The facility was not administered in a manner that enabled it to use its resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as required by 42 C.F.R. � 483.75.

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 physical, mental, and psychosocial well-being of each resident. 42 C.F.R. � 483.75. A finding of substantial noncompliance in the facility's administration may derive from findings of substantial noncompliance in other areas.

[W[here a facility has been shown to be so out of compliance with program requirements that its residents have been placed in immediate jeopardy, the facility was not administered in a manner that used its resources effectively to attain the highest practicable physical, mental, and psychosocial well-being of each resident.

Asbury Center at Johnson City, DAB No. 1815, at 11 (2002).

I discuss below why I conclude that the facility's deficiencies posed immediate jeopardy to resident health and safety, which, itself, justifies the finding that the facility was not in substantial compliance with 42 C.F.R. � 483.75. Moreover, as the discussion above shows, the facility's deficiencies were related to systemic problems for which the facility administration is accountable: the facility had no consistent smoking policy (resident access to cigarettes, lighters, and matches; approved smoking areas); the facility had in place no systematic procedure for assessing the degree of supervision required for its smokers; and the administration did not conduct necessary investigations, most notably, it failed to investigate R10's elopement.

Petitioner argues that facility administration should not be held accountable for its failure to investigate the elopement because staff did not report the incident. First, R10's elopement is not the only example of administrative shortcomings in investigating incidents. Its investigation following R2's February 9 smoking incident was inadequate. Nor is there evidence of administrative efforts to determine how R10 obtained lighters and matches. Second, the administration seems to have been ill-informed on at least one other serious issue: Administrator Jorgenson learned that housekeeping had earlier found cigarette butts in a drawer in R2's room only after R2 had burned himself. P. Ex. 42, at 3. Finally, Petitioner offers no evidence of written policies, staff training, or other administrative efforts to encourage staff to report significant events to the administrative staff.

C. The facility did not meet each resident's special dietary needs, as required by 42 C.F.R. � 483.35.

The facility must provide each resident with a nourishing, palatable, well-balanced diet that meets his/her nutritional and special dietary needs. 42 C.F.R. � 483.35. Among other requirements, food must be prepared in a form designed to meet individual needs (42 C.F.R. � 483.35(d)(3)), and therapeutic diets must be prescribed by the attending physician. 42 C.F.R. � 483.35(e).

Resident #22 (R22) had diagnoses of Alzheimer's Dementia, senile dementia, and dysphagia. CMS Exs. 3, at 28; 33, at 1-2 (Cunningham Decl.). Dysphagia is a swallowing disorder, requiring precautions against aspiration and choking. CMS Ex. 17, at 5; Tr. 107. Among these precautions, R22's physician had ordered honey-thickened liquids. CMS Ex. 3, at 28; Tr. 101. Such thickened liquids are ordered for residents with swallowing difficulties to prevent them from aspirating liquid into their lungs, a danger posed by the thinner liquids. Tr. 102.

Surveyor Lanaya Cunningham, a registered dietician with many years experience (CMS Ex. 33, at 3-4), observed that the orange juice on R22's tray was labeled "nectar- consistency." Nectar-consistency is not as thick as honey-consistency. When Surveyor Cunningham brought this to the responsible nurse's attention, the nurse removed the juice and replaced it with another cup of orange juice that had been thickened appropriately. CMS Ex. 3, at 28.

Petitioner concedes that the facility is supposed to follow physician orders in this regard, but asserts, without providing any support, that the surveyor would not be able to determine the difference between honey-thickened and nectar-thickened liquids unless she tested them with a "viscometer." P. Closing Br. at 26; P. Reply Br. at 20-21. (15) But the surveyor did not have to assess visually the thickness of the juice; it was pre-mixed from the manufacturer and labeled "nectar-thick." Tr. 104, 111. In the absence of any testimony or other evidence challenging the surveyor observation, I find this sufficient to establish that, in contravention of the physician order, the facility was serving R22 a liquid that was not sufficiently thickened. I also find that this deficiency presented the potential for more than minimal harm because it exposed a vulnerable resident to increased risk of aspiration.

Surveyor Cunningham also noted that R22 was being fed by a nurse-aide helper. A nurse-aide helper lacks the training and certification of a nursing assistant. Tr. 101. The helper did not compare the label on the beverage with the physician order, which was written on the tray card. Tr. 111. Nor did the helper understand the difference between honey and nectar-thickened liquids; she thought it was simply a question of taste rather than thickness. CMS Ex. 3, at 28-29; Tr. 101. I agree with Surveyor Cunningham and CMS that assisting people with swallowing difficulties requires specific training and the nurse-aide helper lacked that requisite training. Tr. 114.

Resident # 19 (R19) also suffered from dysphagia, and, to prevent choking, had a physician's order for ground meat. However, Surveyor Cunningham observed that R19 was served shredded turkey for lunch. CMS Ex. 3, at 29. Shredded meat presents an increased risk of aspiration and choking. Tr. 112. Again, the uncontroverted evidence establishes that the facility failed to follow the physician's order; R19's food was not prepared in a form designed to meet her needs; and R19 was exposed to increased risk of injury from aspiration.

The facility was therefore not in substantial compliance with 42 C.F.R. � 483.35 because it did not meet each resident's special dietary needs.

II. CMS's determination that, from April 26 through June 16, 2004, the facility's deficiencies posed immediate jeopardy to resident health and safety was not clearly erroneous.

I next consider whether CMS's immediate jeopardy finding was "clearly erroneous."

CMS's determination as to the level of a facility's noncompliance - which includes its immediate jeopardy finding - must be upheld unless it is "clearly erroneous." 42 C.F.R. � 498.60(c). The Board has observed repeatedly that the "clearly erroneous" standard imposes on facilities a "heavy burden" to show no immediate jeopardy, and has sustained determinations of immediate jeopardy where CMS presented evidence "from which '[o]ne could reasonably conclude' that immediate jeopardy exists." Barbourville Nursing Home, DAB No. 1962, at 11 (2005); Florence Park Care Center, DAB No. 1931, at 27-28, (2004) citing Koester Pavilion, DAB No. 1750 (2000).

Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment or death to a resident." 42 C.F.R. � 488.301. In arguing no serious harm, Petitioner trivializes the seriousness of the incidents here, suggesting that R2 was only "slightly singed," and characterizing R10's elopement as "a short walk." P. Closing Br. at 18, 38.

"Serious injury or harm" does not require that a resident, particularly an elderly or fragile individual, suffer second or third degree burns or some permanent disfigurement. Here, R2 was more than "slightly singed." He suffered first degree burns to his hands and face, causing him pain and requiring treatment in the hospital emergency room. I find this satisfies the standard for "serious injury, harm, or impairment." Moreover, the regulation does not require an actual injury; the likelihood of serious injury is sufficient. The facility is fortunate that R2 was not more seriously injured, and that no one else was injured. The deficiencies that resulted in R2's injuries could easily have caused far greater harm to him or to others. As Director Wolf testified, "fire and oxygen" is "always a concern" because oxygen is so flammable, and lighting a fire in the presence of flowing oxygen risks a "flame up or an explosion." Tr. 20.

With respect to R10, Petitioner asserts that she simply took a "walk across the lawn," and returned to the facility unharmed, so her "elopement" created little or no likelihood of serious harm or injury. I disagree.

That R10 wandered into a neighboring backyard instead of turning toward the street was fortuitous. That she was observed by responsible individuals who took it upon themselves to assist her return to the facility was also fortuitous. But R10's mental condition was severely deteriorating. She was a careless smoker, able to obtain matches and lighters; she was at risk for falls (see CMS Ex. 13, at 37). The facility recognized that she was not even safe alone on the facility's own patio. That this confused and vulnerable resident wandered, alone and unsupervised, outside the facility grounds, and no one at the facility was even aware that she was gone presented for her a strong likelihood of serious injury or harm.

Petitioner also complains about the duration of the immediate jeopardy finding, arguing that two separate, unrelated incidents occurred, so the facility should not be charged with ongoing noncompliance. Again, I disagree.

On April 26, 2004, R10 eloped. For all the reasons set forth above, on that day, the facility was not in substantial compliance with program requirements and its deficiency posed immediate jeopardy to resident health and safety. The presumption is that such non-compliance continues until the facility comes forward and demonstrates correction. See Lake City Extended Care, DAB No. 1658, at 14-15 (1998). The facility must correct the cited deficiency and implement 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 Johnson City, DAB No. 1815, at 19-20 (2002) ("[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 Care Center, DAB No. 1665 (1998).

R10's elopement, by itself, would have justified the immediate jeopardy finding for this entire period because the facility implemented no changes to ensure that residents could not exit the gate adjacent to the smoking area. Indeed, the facility administration was not even aware of the incident until the time of the survey.

But the facility's problems went beyond R10's elopement. As Surveyor Zapetis explained, the surveyors were concerned generally about the supervision (or absence thereof) of the residents to prevent accidents. Between April 26 and June 16, numerous incidents demonstrated that the facility had not corrected its immediate jeopardy deficiencies. During this period, R2 sustained facial and hand burns, but the facility did nothing differently to ensure that residents were properly assessed for their ability to smoke unsupervised and to possess smoking materials to prevent additional smoking-related injuries. P. Ex. 32, at 2 (Zapetis Decl.). Though known to have contraband smoking materials in his possession, no postings advised visitors not to give R2 smoking materials. Although the facility no longer allowed smoking in the dining room, R10 was repeatedly found smoking there. On numerous occasions, she acquired lighters and/or matches, yet the facility did not investigate their source or make efforts to prevent their acquisition. The facility made no efforts to change its policies to address these deficiencies until the time of the survey. Tr. 33.

I therefore do not find "clearly erroneous" CMS's finding that, from April 26 through June 16, 2004, the facility's deficiencies posed immediate jeopardy to resident health and safety.

II. The reasonableness of the amount of the CMP is not before me.

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, � 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), 488.440. In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for causing more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. 42 C.F.R. � 488.483(a)(1)(ii). Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. � 488.438.

For the period of immediate jeopardy, CMS has imposed the minimum per day penalty, $3,050, which must therefore be sustained.

With regard to the $150 per day CMP imposed for the period of noncompliance that was not immediate jeopardy, aside from asserting its compliance, Petitioner has not argued that the amount of the penalty is unreasonable. That issue is therefore not before me. See, Community Nursing Home, DAB No. 1807, at 22 (2002) ( 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.).

Conclusion

The evidence here establishes that the facility was not in substantial compliance with program requirements from April 26 through July 20, 2004. From April 26 through June 16, 2004, the facility's deficiencies posed immediate jeopardy to resident health and safety. The amount of the CMP imposed - $3,050 per day for the period of immediate jeopardy - is mandated by statute and regulation and must be sustained. The $150 per day CMP for 34 days has not been challenged.

JUDGE
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Carolyn Cozad Hughes

Administrative Law Judge

FOOTNOTES
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1. $3,050 per day x 52 days = $158,600. $150 per day x 34 days = $5,100. $158,600 + $5,100 = $163,700.

2. The State Agency recommended a $3,050 CMP from April 26 through June 17, 2004, dropping to $150 per day effective June 18. 2004. However, because CMS determined that the immediate jeopardy was corrected as of June 17, 2004, it imposed the $3,050 CMP through June 16, and dropped the penalty to $150 per day effective June 17. CMS Ex. 6 at 1, 2.

3. I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding in italics as a separate heading.

4. However, as discussed below, the record also establishes that at least one resident, R2, regularly smoked on the front porch (P. Ex. 19, at 6, 8, 9, 12), a practice that did not comport with the facility's articulated smoking policy.

5. I discuss below the failure of facility staff to document or report this incident.

6. Petitioner incorrectly states that R2 was admitted on February 5, 2004, citing P. Ex. 8, at 1. P. Closing Br. at 11. But that document only shows that a care plan review sheet identifying R2 as a "new admit" was filled out on February 5. Other assessments are dated earlier. P. Ex. 6, at 2, 3, 4, 5, 7, 8, 9, 10, 11. All of Petitioner's witnesses say he was admitted in January. P. Ex. 43, at 2; P. Ex. 44, at 1; P. Ex. 45, at 2. Elsewhere in its brief, Petitioner asserts that R2 was admitted to the facility on January 20, 2004. P. Closing Br. at 15.

7. The record contains conflicting evidence as to whether R2 had initially been allowed to keep a cigarette lighter. Director Wolf's testimony suggests that he was not. But R2's wife testified that he was. Tr. 14. Based on the written policy, he should not have been allowed a lighter, but, according to Administrator Jorgenson, "safe" smokers were allowed to keep them during the day, and, according to Nurse Piner, the facility considered R2 a "safe" smoker until the May 5, 2004 incident.

8. It seems that, soon thereafter, R2's treating physician discontinued the Percocet, noting that his other pain medications were sufficient. P. Ex. 13, at 2.

9. Staff also found cigarette butts in a dresser drawer, but Petitioner claims that "it was not clear how old they were, or even whether they belonged to the resident." P. Closing Br. at 19. Petitioner also explains that R2 had a habit of "hoarding" cigarette butts (P. Ex. 44, at 2 (Clarke-Baker Decl.)). Even if this arguably explains the butts found in his dresser, it does not explain the cigarette butt found on the floor.

10. Petitioner argues at some length that I should discount as unreliable hearsay the surveyor testimony that facility staff told them that residents, including R2, kept cigarettes, lighters, and matches. P. Closing Br. at 13. Of course, hearsay is admissible in these administrative proceedings (42 C.F.R. � 498.61), and, even if hearsay were not otherwise admissible, such statements would likely fall within an exception to the hearsay rule (declaration against interest). In any event, the surveyor testimony is wholly consistent with testimony from Petitioner's own witnesses and other evidence. Administrator Jorgenson testified that "safe" smokers were allowed to keep cigarettes and lighters. Tr. 127. As discussed below, Nurse Piner, who was responsible for assessments, assessed R2 as a "safe" smoker. R2's wife said that R2 was initially allowed to keep a lighter and matches. Tr. 14. And, as R10 demonstrated and as staff surely realized, even a seriously demented resident had little difficulty obtaining these items.

11. The record contains a "Safe Smoking Assessment" for R2 dated June 17, 2004 - about 6 weeks after he burned himself. Because his vision was inadequate, he was not able to communicate his understanding that smoking materials were "for his own personal use," and he was not able to communicate that he understood that smoking materials could be used only in the designated smoking area, R2 was then determined to be an unsafe smoker who required constant supervision while smoking. According to the facility's assessment tool, any one of these factors warranted the finding of "unsafe smoker." CMS Ex. 25, at 23.

12. Of course, if the resident consented, the search would not be involuntary. But at this time no one asked him to consent.

13. I consider this "phantom relative" assertion pure fabrication. But even if R10 had been visited by a relative who subsequently abandoned her on the patio, this would not have relieved the facility of its obligation to provide her the close supervision she required.

14. The facility claims that R10's elopement was an isolated instance (Tr. 41), but CMS's point is well-taken - where staff fail to document or report such incidents, the absence of any record means very little.

15. Of course, if Petitioner's theory were correct, the facility itself should not have been serving R22 any liquids without first testing them with a viscometer. And if a trained dietician is not able to assess visually the thickness of a liquid, what does it mean that the facility apparently had only an untrained nurse-aide helper making that judgment?

CASE | DECISION | JUDGE | FOOTNOTES