Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
|IN THE CASE OF|
Woodbine Healthcare & Rehab Centre,
|DATE: July 24, 2006|
- v -
Centers for Medicare & Medicaid Services.
| Docket No.C-03-512
Decision No. CR1476
For the reasons stated below, I conclude from a preponderance of the evidence that Woodbine Healthcare & Rehab Centre (Petitioner or Facility) was substantially non-compliant with requirements for long-term care facilities to participate in Medicare and Medicaid and, accordingly, the Centers for Medicare & Medicaid Services (CMS) had a basis to impose a denial of payment for new admissions (DPNA) on Petitioner from April 25, 2003 through June 25, 2003.
Petitioner is a 300-bed skilled nursing facility in Gladstone, Missouri. Petitioner's Prehearing Brief (P. PreBr.) at 2; see P. Ex. 4. The Missouri Department of Health and Senior Services (State agency) conducted an abbreviated survey of Petitioner's facility which ended on April 22, 2003. Based on that survey, the State agency concluded that Petitioner was not in substantial compliance with the Medicare and Medicaid requirements for participation and that certain of the conditions in the Facility constituted immediate jeopardy to residents' health and safety. The State agency advised Petitioner on April 23, 2003, that a DPNA would be effective on April 25, 2003. On May 7, 2003, the State agency began a revisit survey to determine if Petitioner had abated immediate jeopardy. The State agency concluded that Petitioner had removed the immediate jeopardy but still remained non-compliant with participation requirements. On May 15, 2003, CMS notified Petitioner that the DPNA would be effective until Petitioner achieved substantial compliance. The State agency concluded an abbreviated survey on May 29, 2003. On June 12, 2003, the State agency notified Petitioner that it would recommend to CMS that the DPNA remain in effect. Petitioner timely filed a request for hearing on June 19, 2003. After another revisit survey on June 26, 2003, the State agency found that Petitioner had returned to compliance. On July 10, 2003, CMS notified Petitioner that it concurred with the State agency and discontinued the DPNA as of June 26, 2003.
Petitioner filed a motion for summary judgment on September 25, 2003, along with three proposed exhibits marked P. Exs. A-C. On October 24, 2003, CMS filed its response and five proposed exhibits marked CMS Exs. 1-5. On November 7, 2003, Petitioner filed a reply brief. On February 8, 2005, I denied Petitioner's motion and set the case for a hearing to begin on July 26, 2005. Petitioner filed a pre-hearing brief on May 20, 2005 (P. PreBr.). On July 8, 2005, Petitioner filed a waiver of an in-person hearing and asked that the case be decided on the record and briefs. Because CMS had filed a very abbreviated pre-hearing brief (CMS PreBr.), I invited CMS to file another statement outlining its evidence and arguments. Thereafter, CMS filed a brief on August 19, 2005 (CMS Br.) and Petitioner filed its brief on September 23, 2005 (P. Br.). In their final exchanges of exhibits, CMS submitted three proposed exhibits (CMS Exs. 1-3), and Petitioner filed 42 proposed exhibits (P. Exs. 1-42). All proposed exhibits are admitted without objection.
II. Applicable law and regulations
Petitioner is considered a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.
Sections 1819 and 1919 of the Act invest the Secretary with authority to impose penalties against a long-term care facility for failure to comply substantially with federal participation requirements.
Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. 42 C.F.R. Part 488 provides that facilities participating in Medicare may be surveyed on behalf of CMS by state survey agencies in order to ascertain whether the facilities are complying with federal participation requirements. 42 C.F.R. §§ 488.10-488.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. §§ 488.300-488.335. The regulations in 42 C.F.R. Part 488 give CMS a number of different remedies that can be imposed if the facility is not in compliance with Medicare requirements. Under Part 488, a state or CMS may impose a denial of payment for new admissions against a long-term care facility when a state survey agency determines that the facility is not complying substantially with federal participation requirements. 42 C.F.R. §§ 488.406, 488.408, 488.417.
If substantial noncompliance has been shown, the remedy continues until "[t]he facility has achieved substantial compliance, as determined by CMS or the State based upon a revisit or after an examination of credible written evidence that it can verify without an on-site visit; . . . ." 42 C.F.R. § 488.454(a)(1). The regulation further provides that "[i]f the facility can supply documentation acceptable to CMS or the State survey agency that it was in substantial compliance and was capable of remaining in substantial compliance, if necessary, on a date preceding that of the revisit, the remedies terminate on the date that CMS or the State can verify as the date that substantial compliance was achieved and the facility demonstrated that it could maintain substantial compliance, . . . ." 42 C.F.R. § 488.454(e).
The regulations define the term "substantial compliance" to mean "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.
Substantial noncompliance that is immediate jeopardy is defined as "a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident." 42 C.F.R. § 488.301. In order for an administrative law judge (ALJ) to overturn CMS's finding of immediate jeopardy, the ALJ must find that CMS's determination of immediate jeopardy is clearly erroneous. 42 C.F.R. § 498.60(c)(2); Ridge Terrace, DAB No. 1834 (2002).
The Act and regulations make a hearing before an ALJ available to a long-term care facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. §§ 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al., DAB CR65 (1990), aff'd, 941 F.2d 678 (8th Cir. 1991).
When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dep't of Health and Human Services, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); see Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004). Under Hillman and Batavia, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Once CMS has established a prima facie case of noncompliance, Petitioner has the burden of proving, by a preponderance of the evidence, that it complied substantially with participation requirements. Hillman, DAB No. 1611, at 3-8.
The issues in this case are: (1) whether CMS had a factual basis to impose remedies against Petitioner for failing to comply substantially with federal requirements; (2) if so, whether CMS's decision that the deficiencies put Petitioner's residents in immediate jeopardy was clearly erroneous; and (3) whether Petitioner achieved substantial compliance prior to the date CMS assigned; that is, June 26, 2003.
IV. Findings of Fact and Conclusions of Law (1)
A. CMS presented a prima facie case, and Petitioner failed to prove by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. § 483.25(h)(2). (2)
Resident 1, aged 88, was admitted to Petitioner's facility on April 11, 2003, at 5:00 p.m. CMS Ex. 1, at 48; P. Ex. 32, at 1. The Statement of Deficiencies (SOD) for the April 22, 2003 survey states that, prior to admission, he had lived at home with his spouse. His diagnoses included Alzheimer's disease. CMS Ex. 1, at 48. He could ambulate but could only acknowledge or state his name, not where he lived. Id.; see Id. at 58. On the day he arrived, Resident 1 ate supper at 6:30 p.m. About an hour later, Resident 1's stepdaughter called the Facility and reported that Resident 1 had just arrived at the front door of the family's residence about two miles from the Facility. CMS Ex. 1, at 49, 51. A young couple had apparently picked up Resident 1 on the street and drove him in their car to his family's house. Id. at 51. Because Resident 1 could provide only his name, the couple either looked at an old driver's license Resident 1 had in his wallet and/or called local police to find his home address. CMS Ex. 1, at 53; CMS Ex. 2, at 32, 39, 40, 68. The Facility staff did not know Resident 1 was missing until the stepdaughter phoned the Facility and advised the staff. CMS Ex. 1, at 53. Resident 1 was returned to the Facility and was not injured during his elopement. Resident 1 was moved immediately to Petitioner's secured unit (700 hall) for day care and the next day he was assigned to the secured unit. (3) Id. at 49, 53. Upon Resident 1's admission, space in the Facility's secured unit on a full time basis was unavailable.
The regulation at 42 C.F.R. § 483.25(h)(2) requires a facility to ensure that each resident receives adequate supervision and assistance devices to prevent accidents. CMS alleges (under Tag F324) that Petitioner failed to comply with this section of the regulations due to four elopements from the facility between April 11 and May 9, 2003. CMS Ex. 1, at 9-22, 48-68.
With respect to Resident 1's first elopement, Petitioner argues that Resident 1 was a new admission and his family members did not make the Facility aware that he was an elopement risk. P. Ex. 32, at 6, 9, 11; P. Ex. 33, at 4, 5; P. Ex. 35; P. Ex. 36. Further, Resident 1's medical records given to the Facility upon his admission include a note from his attending physician that Resident 1 was not at risk for wandering or elopement. P. Ex. 32, at 16. As there was no indication that Resident 1 was at risk for elopement, Petitioner argues it could not have known that special supervision was required.
A facility is not cited with a deficiency merely because a resident elopes. In cases involving a facility's compliance with 42 C.F.R. § 483.25(h), however, the focus is on the affirmative duty of the facility to establish that it took measures that are designed to the extent practicable to ensure that residents unable to care for themselves outside the facility do not elope. See Koester Pavilion, DAB No. 1750 (2000). In explaining what a facility must do, an appellate panel of the Departmental Appeals Board (DAB) has stated that "a facility is not required to do the impossible or be a guarantor against unforeseeable occurrences, but is required to do everything in its power to prevent accidents." Koester Pavilion, DAB No. 1750, at 26. As the DAB has recently stated,
Golden Age Skilled Nursing & Rehabilitation Center, DAB No. 2026, at 10-11 (2006).
Moreover, while a single elopement episode may or may not show that a facility has failed to implement adequately an elopement prevention policy, repeated episodes centered on a failure for attentive staff supervision certainly raises an inference that the Facility has a systemic problem and has either an inadequate anti-elopement system or has failed to implement its anti-elopement policies. See Emerald Oaks, DAB No. 1800 (2001). The essential question is whether a facility has notice, or should reasonably have anticipated the risk of the elopements that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. See Woodstock Care Center, DAB No. 1726 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003).
I concede it remains unclear whether Resident 1's family advised the admitting staff that Resident 1 was an elopement risk. CMS Ex. 2, at 36, 100. The Facility staff members say they were not so advised. P. Ex. 32, at 11; CMS Ex. 2, at 39-40, 46, 52, 57-59. Resident 1's stepdaughter, however, asserts it was discussed during Resident 1's admission. Resident 1's wife, his former caretaker, remembered that she mentioned Resident 1 was a "roamer." CMS Ex. 1, at 52. Nonetheless, although Petitioner argues that Resident 1's elopement on his first day at the Facility was not a foreseeable risk, especially because his family did not indicate he was a roamer, Resident 1's family did provide the Facility with sufficient information to suggest that Resident 1 was unable to protect himself in many situations and would need attentive supervision. On admission, Resident 1's stepson-in-law related his view that Resident 1 had the mentality of a 3-year- old, did not initiate anything on his own and had to be instructed to do anything. CMS Ex. 2, at 40; P. Ex. 33, at 5. Moreover, although Resident 1's spouse had been his caretaker, was his durable power of attorney, and likely could better provide the needed information, the staff asked Resident 1's stepdaughter and stepson-in-law to fill out the paperwork that the Facility used at admission to determine if a new resident was at risk for wandering. CMS Ex. 1, at 52; see CMS Ex. 2, at 100; P. PreBr. at 14.
Furthermore, the Facility's Initial Wandering Assessment Guide advised staff to implement safety measures if a new admission could ambulate independently and had dementia. CMS Ex. 1, at 49. Moreover, the form contained the following information for the staff:
CMS Ex. 2, at 100.
Petitioner should have reasonably anticipated Resident 1's elopement. Petitioner could be expected to know that a new admission with Resident 1's stage of dementia would be confused by his change of residence and he would be unable to fend for himself away from the Facility. Only more attentive and frequent supervision would have been adequate for a new arrival in Resident 1's status. Petitioner could have reasonably prevented his elopement simply by watching him more closely on his first hours in the Facility. To show the inadequacy of supervision, I note that Resident 1 had walked to the highway, got into a car with strangers and was (fortunately) delivered to his old residence without anyone on Petitioner's staff realizing Resident 1 was gone. Petitioner failed to provide adequate supervision to Resident 1.
Resident 2 was readmitted to the Facility on December 2, 2002, after a hospitalization. His diagnoses included dementia. CMS Ex. 1, at 62; CMS Ex. 2, at 20. The SOD notes that an assessment completed by the Facility on January 2, 2003, indicated that Resident 2 had long and short-term memory problems and severely impaired decision-making skills. The assessment also indicated that Resident 2 was wheelchair bound and needed others to propel his wheelchair. CMS Ex. 1, at 62.
On April 12, 2003, the day after Resident 1 had eloped, Resident 2 had been outside the Facility since 10:30 a.m. watching the Facility's Easter egg hunt for local children. The staff brought Resident 2 inside. A staff member then noticed Resident 2 wheeling himself to the front door. She removed him from the front door area and took him back to his hall. Around 12:30 p.m., a visitor came into the Facility and told staff he had seen a person in a wheelchair on the parkway in front of the Facility. CMS Ex. 1, at 63; CMS Ex. 2, at 3, 4, 6, 13; P. Ex. 38, at 1. The staff went outside and saw Resident 2. CMS Ex. 2, at 14-16. The staff brought Resident 2 back into the building. Resident 2 was gone less than ten minutes and was uninjured. CMS Ex. 1, at 63; CMS Ex. 2, at 1. Resident 2 had not previously eloped. See CMS Ex. 2, at 4; P. Ex. 38, at 1.
The State agency surveyors observed a moderate amount of traffic on the street south of the Facility's main entrance where a staff member had found Resident 2. The street had four traffic lanes with a median between the east bound and west bound lanes. The immediate surroundings included both residential and business areas. CMS Ex. 1, at 63.
The Facility's "Initial Wandering Assessment Guide" for Resident 2, completed on February 2, 2003, failed to show Resident 2's dementia even though his diagnoses included dementia. CMS Ex. 1, at 62; CMS Ex. 2, at 10. Given Resident 2's ability to elope and get to the highway, the Facility's assessment that he was unable to self-propel his wheelchair was also clearly incorrect. CMS Ex. 1, at 62; CMS Ex. 2, at 10. In fact, Resident 2 could move his wheelchair without assistance and Facility staff knew it. (4) The Wandering Guide indicated that changes in residence could increase a resident's wandering behavior. CMS Ex. 2, at 10. Petitioner's staff moved Resident 2 to three different rooms, on three different hallways, the week before his elopement. CMS Ex. 1, at 62.
Petitioner argues that Resident 2's elopement was unforeseeable because Resident 2 had not previously eloped. Nurses' notes, however, suggest that Resident 2 had previously exhibited exit-seeking behavior and that a factor increasing such behavior was present; i.e., his having recently been moved from room-to-room. P. Ex. 37, at 51. Petitioner's supervision was inadequate for Resident 2 also because, while he had the ability to move around in his wheelchair, he likely would have been unable to move quickly enough to avoid dangers such as traffic had it become necessary. His decision-making skills were limited. And there is evidence that Resident 2 had actually gotten onto the highway. CMS Ex. 1, at 64-65. Luckily someone spotted him in the road and reported it to the Facility staff. CMS Ex. 2, at 6. The Facility staff had not noticed his absence even though one staff member had seen Resident 2 wheeling himself toward the front door. The Facility had not considered Resident 2 to be an elopement risk even though some staff members knew he often talked about going home. CMS Ex. 1, at 64-65; CMS Ex. 2, at 14 - 15. Petitioner could have reasonably anticipated Resident 2's elopement and there were reasonable methods available to prevent it such as watching him more closely after he wheeled himself to the front door. I conclude Petitioner's supervision of Resident 2 was inadequate.
The next day after his elopement, Resident 2 continued to be agitated and made attempts to go outside. The staff moved him to a different room on a different hall. Resident 2 again went to the front desk and attempted to leave. The staff then put Resident 2 in the secured unit for daycare. CMS Ex. 1, at 63-64; CMS Ex. 2, at 5, 7. Resident 2's picture was taken and placed with a staff member at the front door and an alarm was installed at the door. CMS Ex. 1, at 67-68; CMS Ex. 2, at 5. While measures such as alarms are important in preventing elopements, staff attention is at least equally important. A certified nurse aide told a state agency surveyor that, on April 15, 2003, he worked on the secured unit for the first time in many years but was not told of Resident 2's recent elopement. CMS Ex. 1, at 66.
After Resident 1's elopement on April 11, 2003, the Facility made space on the secured unit for him. CMS Ex. 1, at 55. During the next few days following Resident 1's first elopement, Resident 1 repeatedly requested to go home and asked how to unlock the secured unit doors. On April 14, 2003, three days after his admission, Resident 1 stood by the door and attempted to exit as staff came and left through the door. He did get out one time and was retrieved. CMS Ex. 1, at 55, 57; CMS Ex. 2, at 70.
The next morning on April 15, at 9:00 a.m., an LPN gave Resident 1 his medication. Twenty minutes later, at 9:20 a.m., an employee at a law office about ˝ mile from the Facility phoned the Facility and said Resident 1 was at the firm's office. CMS Ex. 1, at 55, 57; CMS Ex. 2, at 72; P. Ex. 32, at 7. The law office employees first saw Resident 1 about a block north of the office. Resident 1 then walked on the sidewalk across the road and for some reason stopped and stared at their business for some time. At about 9:15 a.m., Resident 1 crossed the street, walked up to the front door of the law firm and stood there. One of the employees opened the door and asked Resident 1 if he needed help. Resident 1 said that he was lost and sick and asked them to call his father. He gave his name and said he lived in Gladstone. CMS Ex. 1, at 58; CMS Ex. 2, at 21. The law firm employees first called another nearby nursing facility and then Petitioner's. CMS Ex. 1, at 58; CMS Ex. 2, at 21, 72. The Facility staff was unaware that Resident 1 was gone until the law firm employee called the Facility. CMS Ex. 1, at 59. Resident 1 was returned to the Facility and was uninjured. Id.
The State agency surveyors later observed the street which Resident 1 had crossed twice to get to the law office. The street provided access to numerous businesses on both sides of the street and to a residential area that contained single family units and apartment complexes. A moderate amount of traffic filtered from a major four lane road located one block west of the facility and law office. CMS Ex. 1, at 58-59.
Several of the rooms on the secured unit had sliding glass patio doors. Petitioner's staff thought pins were in the doors so the doors would open only wide enough for ventilation. One of Petitioner's staff members went into room 702 around 9:00 a.m. on the day Resident 1 eloped the second time and saw the sliding door was open. A maintenance man came into the room, closed the door, and advised Petitioner's Assistant Director of Nursing. CMS Ex. 1, at 60-61; see P. Ex. 14, at 2. There is no record evidence that the staff checked to account for all residents on the secured hall at that time.
As a result of the elopements which had been reported to the State agency, a State agency surveyor arrived at the Facility on April 15, 2003 (at 9:55 a.m.), soon after Resident 1 had been returned from the law firm (around 9:30 a.m.). CMS Ex. 1, at 57. Around 11:00 a.m., the surveyor saw that the sliding glass door in room 702, on the secured unit, was partially open and/or was partially off its track. The room was open to an unsecured area of lawn and to a street immediately behind the facility. Id. at 60. The surveyor determined that five of the rooms on the secured unit had sliding glass doors and that two of the five opened freely to an unsecured lawn. Id.; CMS Ex. 2, at 74. Later investigation revealed that the Facility had no regularly scheduled monitoring system for the patio doors. CMS Ex. 1, at 61; CMS Ex. 2, at 23, 75. Petitioner's administrator and maintenance worker said they were unaware that the doors could open. CMS Ex. 1, at 60; CMS Ex. 2, at 72a.
Petitioner speculates that Resident 1 had disassembled the pin locks on the room 702 patio door and eloped through it. P. PreBr. at 22. Resident 1 had a long career as an aircraft mechanic with TWA. P. Ex. 32, at 4. The Facility surmised that because of his years with the airline and despite his Alzheimer's, Resident 1's mechanical problem-solving skills were still at a high level of functioning. I am less certain than Petitioner that Resident 1 disassembled pin locks. Other possibilities for Resident 1's egress existed. See, e.g., CMS Ex. 2, at 62-63, 75, 98. Regardless, that Petitioner did not know of Resident 1's mechanical abilities does not relieve Petitioner of its obligation to watch him and notice his absence.
Facility staff should have been acutely aware that Resident 1 was an elopement risk and unable to navigate alone outside. I note that a law firm employee saw Resident 1 when he appeared close to the law firm entrance and the employee led him into the office. The employee noted Resident 1's confusion. Finally, I fail to understand how a "secured" unit could have sliding patio doors without scheduled inspection of the doors' security features. I conclude Petitioner's supervision was inadequate with respect to Resident 1's second elopement in less than a week's time. Resident 1's family moved him from the Facility after this incident.
Resident 3 was admitted to the Facility on or about the end of March in 2003. (5)
He had long and short-term memory problems and his diagnoses included Alzheimer's disease. The Facility assessed Resident 3 on April 29, 2003, and indicated he had impaired decision-making skills. He was easily distracted, had altered periods of perception, episodes of disorganized speech, periods of restlessness and his mental function varied over the course of the day. He had wandered (moved with no rational purpose, seemingly oblivious to needs or safety) in four to six of the days in the week prior to his assessment. CMS Ex. 1, at 9-10; P. Ex. 23, at 7-8. Resident 3's care plan included: 15 minute checks, redirection when Resident 3 tried to leave the Facility, a photo of him at the front door, notification of the staff that he was at risk for elopement, daily activities, and a wander alert device on his person. CMS Ex. 1, at 10. The Facility staff was aware that Resident 3 should be in a secure unit. No bed, however, was available on the secured unit and Resident 3's family was reluctant to place him in the unit. CMS Ex. 1, at 21; P. Ex. 41, at 148.
On May 9, 2003, at 3:00 p.m., Resident 3 was at the nurses' station. That evening, Resident 3 was repeatedly walking back and forth at the front door and his wander alert device was setting off the alarm. He engaged in that activity for about 45 minutes. CMS Ex. 1, at 10, 15. At the nurses' station, Resident 3 asked for his car. He was restless most of the evening. Id. at 14. At 4:50 p.m. Resident 3 went to the dining room for supper. Id. at 10. He attempted to go out of the front door after supper. Id. at 15. The receptionist did not tell anyone on the hall that Resident 3 had been trying to get out of the building. Also after supper, about 6:05 p.m., Resident 3 began to shadow an LPN while she was doing a medication pass. He repeated to her that he wanted to go home. Id. at 10. The LPN redirected him to his room and he expressed he did not belong there. Resident 3 began to shadow the LPN again and she asked a CNA to take him back to his room. Id. at 10-11.
Facility staff was unaware that he was gone until a family member called the Facility and advised that Resident 3 was apparently at a fire station about a mile from the Facility. At 8:25 p.m., a police officer returned Resident 3 to the Facility. CMS Ex. 1, at 11; CMS Ex. 2, at 181. Soon after Resident 3 was returned, a visitor to the Facility reported an earlier observation of Resident 3 around 7:55 p.m. at an intersection near the parking lot talking to someone in a stopped car. CMS Ex. 1, at 15, 17.
Resident 3's care plan called for 15-minute checks of his whereabouts. The CNA who was working as an extra on Resident 3's hall and was to do the 15-minute checks reported to surveyors that the nurse had not given her a 15-minute check or assignment sheet. This CNA did know, however, that Resident 3 was to be checked every 15 minutes. CMS Ex. 1, at 12-14. This CNA said she told another CNA who arrived later at 4:30 p.m. that Resident 3 was an elopement risk. Id. at 13. The arriving CNA later reported to surveyors that she was unaware of the required 15-minute checks for Resident 3 and was given no checking documentation. Id. at 14. The RN coming on duty for the evening shift at the Facility on May 9, 2003, knew that Resident 3 was an elopement risk, but staff members had not advised her that Resident 3 had increased exit seeking behaviors earlier during the day. Id. at 19-20.
Petitioner's facility administrator reported after investigation that a dietary employee had seen Resident 3 in the Facility's back parking lot on the evening Resident 3 eloped but she did not recognize Resident 3 as a resident at that time. A visitor also reported that she had seen Resident 3 on the street corner by the Facility at 7:55 p.m. Someone apparently picked up Resident 3 in his or her car and took him to the fire station. CMS Ex. 1, at 16. The car's driver told paramedics at the fire station that he had picked up the elderly gentleman on the corner down the street. The gentleman could not provide a name or address but said someone had dropped him off at a medical office. Id. at 17-18. At the fire station, the paramedics observed that Resident 3 was confused and could not provide them with any identification other than his name. He was able to tell them a family member's name and the paramedics found it in the telephone book. Id. at 18. The Facility was unaware until called by a family member that Resident 3 was absent. Resident 3 was returned to the Facility. It was noted that he was wearing his wander alert bracelet. Id. Resident 3 was not injured during his elopement.
The State agency had begun a revisit survey of Petitioner on May 7, 2003. CMS Ex. 2, at 154. Surveyors were at the Facility on May 12, 2003, after the latest elopement. See CMS Ex. 1. The surveyors observed that Resident 3's wander alert device activated only two of 35 exits from the facility. As of May 12, 2003, the State agency determined that Petitioner was still noncompliant with Medicare requirements at the immediate jeopardy level. Id. at 21.
Upon further investigation of Resident 3's elopement, Petitioner determined that a resident and family member had disarmed an alarm button near a nurses' station. Petitioner then created a protective cover to deter access to the alarm silencing button and advised staff, residents and family members not to disturb the alarm button. CMS Ex. 2, at 196-98; P. Ex. 18, at 2.
Petitioner knew Resident 3 was an elopement risk but argues that it could not foresee a third party's disabling of an alarm door. Intervention by a third party might relieve a facility of a finding of noncompliance. In this situation, however, Petitioner's deficiency stems additionally from the fact that adequate staff attention to Resident 3 was missing and the Facility staff was again unaware of Resident 3's absence. Resident 3 had been expressing obvious elopement behaviors, his attached alarm did not work at all doors, and he was to be on 15-minute checks. Resident 3 was gone for more than 15 minutes. He had exited the Facility, gotten into a stranger's car and was delivered to a fire station. I conclude Petitioner's supervision of Resident 3 was not adequate.
B. CMS's determination that Petitioner's noncompliance posed immediate jeopardy is not clearly erroneous.
In this case, CMS assigned a scope and severity level to the cited elopements as posing a risk of immediate jeopardy to the residents. As noted above, CMS assessed a DPNA. Although both parties alluded to CMS's finding of immediate jeopardy in their hearing briefs, neither party addressed my jurisdiction to reconsider CMS's immediate jeopardy classification.
Appeal rights attach to certain initial determinations made by CMS as set forth in the regulations. The level of noncompliance, in this case immediate jeopardy, can be appealed but only if: (1) the range of CMP that can be collected could change, or (2) a finding of substandard quality of care leads to the loss by a facility of the approval of its nurse aide training program. 42 C.F.R. §§ 498.3 (b)(14)(i) and (ii), 498.3(d)(10)(i) and (ii).
Because the penalty assessed in this case is a DPNA, a finding of immediate jeopardy can have no effect on a range of penalties. The only way CMS's assessment of immediate jeopardy can be an appealable initial determination is if the finding of substandard quality of care will affect the Facility's nurse aide training program. Neither party in this case submitted evidence that Petitioner has a nurse aide training program. If Petitioner has no training program, I have no jurisdiction to consider CMS's assignment of immediate jeopardy to the noncompliance at issue.
In the alternative, should Petitioner have an approved nurse aide training program, I find that CMS's assignment of immediate jeopardy is not clearly erroneous. Immediate jeopardy is defined in the regulations as "a situation in which the provider's non-compliance 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.
Admittedly, none of Petitioner's residents suffered serious harm or injury as a consequence of their elopements. Nonetheless, a parkway was in front of the Facility. The highway in front of the fire station, about one mile from the Facility, had a speed limit of 45 miles per hour. The highway had four lanes of traffic with a center turn lane. CMS did not measure the traffic in the evening but CMS determined the highway was heavily traveled at 1:50 p.m. in both directions. The surrounding area included residences and businesses. CMS Ex. 1, at 18-19.
All three of the residents who eloped the Facility between April 11 and May 9, 2003 had limited orientation. They walked or wheeled out into an area that had a four-lane highway. Two knew only their names but not where they lived. Resident 2 had difficulties maneuvering his wheelchair and was next to, if not on, the highway. CMS Ex. 2, at 13. All had limited decision-making skills. Two of the eloping residents got into cars with strangers. Luckily the strangers deposited them at safe havens. Had any of these residents had a health emergency, it is likely a rescue would have taken far longer given their elopements than had the residents been safely inside the Facility. The high possibility of serious injury with these elopements is patent. Moreover, given the Facility's lack of implementation of a working elopement prevention plan to include appropriate supervision, the likelihood of other elopements was high. In these circumstances, I cannot find that CMS's determination of immediate jeopardy was clearly erroneous.
C. Petitioner failed to show that it regained compliance prior to June 25, 2003, as CMS determined based on a revisit.
CMS initiated a revisit survey on May 7, 2003. CMS did not deem the survey completed until May 29, 2003. CMS Ex. 1. By May 29, CMS had determined that Petitioner had removed immediate jeopardy but remained noncompliant with participation requirements. CMS Ex. 1, at 21. CMS advised Petitioner on July 10, 2003, that the State agency determined after a revisit on June 26, 2003, that Petitioner was back in substantial compliance. The DPNA would be removed as of June 26, 2003. P. Ex. 26. Petitioner argues that even if it is found to have been out of compliance due to the elopements, it came back into compliance prior to the date of CMS's revisit on June 26, 2003, and that its DPNA should end prior to that date.
Petitioner contends that, at the very latest, it reached substantial compliance by May 22,2003 by virtue of several measures it had taken to prevent elopements from the Facility. (6) P. PreBr. at 33. CMS responds that Petitioner's various plans of correction had indicated the several measures taken by the Facility to correct the deficiency at Tag F324. These measures, according to CMS, however, required a revisit to determine whether the alleged corrections had actually been made. CMS refers to the regulations at 42 C.F.R. § 488.417(d) for the rule that when a DPNA has been imposed, payments to the Facility resume prospectively on the date that the facility achieves substantial compliance, as indicated by a revisit or written credible evidence acceptable to CMS. CMS Br. at 6-7.
In its brief, CMS basically argues that CMS could never find written evidence credible or acceptable. "Surely Petitioner does not expect the agency charged with the fiduciary duty of properly dispensing Medicare and Medicaid funds to rely solely on written allegations of an interested party . . . ." CMS Br. at 6. Contrary to CMS's argument, the regulations do provide for CMS to accept written evidence if it is credible. Generally, however, a facility's return to substantial compliance must be established through a resurvey, and if deficiencies involve inadequate supervision, requiring such a resurvey seems wise. Cross Creek Health Care Center, DAB No. 1665 (1998).
Nonetheless, CMS can insist on a resurvey and still determine that a facility reached compliance prior to the date of resurvey. 42 C.F.R. § 488.454(e). CMS cannot impose a remedy through the date of a followup survey if the facility can demonstrate that the error or deficiency was corrected prior to the survey. Therefore, I conclude I must review the evidence and determine whether indeed Petitioner reached compliance sooner than determined by CMS; that is, before June 26, 2003. Palm Garden of Gainesville, DAB No. 1922 (2004). However, as emphasized in other prior cases, a petitioner has the burden of showing that it was substantially compliant prior to the date determined by CMS. Petitioner's noncompliance found during a survey establishes a presumption that Petitioner was not complying on dates thereafter. CMS has no affirmative burden to offer additional evidence to prove that Petitioner was not complying after May 11, 2003. Barn Hill Care Center, DAB No. 1848 (2002); Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002). Plus, substantial compliance means not only that the specifically 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. Barn Hill, DAB No. 1848, at 15 (emphasis added).
Petitioner contends that even prior to the first elopement on April 11, Petitioner had security measures in place. P. PreBr. at 21. For example, according to Petitioner, of all the exterior doors to the Facility, only two were unalarmed, the front main door and the back door of the therapy department. Each nurses' station had a panel that monitored all of the door alarms. The Facility had one secured unit (700 hall) which housed Alzheimer residents and others particularly at risk for elopement. Id. Petitioner claims the five sliding glass patio doors as well as all of the windows on the secured unit had pin locks in place. Petitioner claims also to have kept a photo book at the front desk with the receptionist that contained photos of those residents identified as at risk for elopement. Id. at 22.
Not only is it clear from the four elopements that occurred after April 11 that something was amiss in Petitioner's elopement prevention procedures, I note that record evidence shows that the sliding glass patio doors on the secured unit were not monitored for security and two could be opened. Further, the book at the receptionist's desk near the front door with photographs of those at risk for elopement was not current. CMS Ex. 1, at 67-68.
Petitioner claims that, after April 15, 2003, the Facility took further measures to prevent elopements such as, among others:
I do not find all of Petitioner's claims particularly persuasive with respect to its alleged compliance on a date prior to June 26, 2003. While I am considering Petitioner's compliance date de novo and my decision is based on the record evidence and not on how CMS evaluated the situation, it appears the State agency was acting responsibly in requiring a revisit to determine compliance. As noted above, although Petitioner claimed to have locked the patio doors in the secured unit and said the Facility had a photo book of at-risk residents at the front desk, these preventative measures had not been fully implemented. As another example, Petitioner claims that by April 17, all residents identified for either elopement or wandering were coded with a smiley face sticker on the nurse aide care plan, the resident's durable equipment, and the resident's room. P. Ex. 3, at 3; P. Ex. 5, at 6-8. Indeed, on a Facility document titled "Executed Plan of Correction for Removal of Immediate Jeopardy," Petitioner alleged jeopardy had been removed by April 16, 2003, and one action included that "[a]ll residents identified for either elopement or wandering propensities will be coded with a Smiley Face on the Nurse Aid Care Plan, the resident's durable equipment and the resident's room." CMS Ex. 2, at 162. Record evidence shows that as of May 7, 2003, not all of the labels were in place or had been placed correctly. CMS Ex. 2, at 154, 161.
On May 5, Petitioner decided to install the "Home Free" wireless monitoring system on the front door and elevator on the 300 hall leading down to the therapy department which had an exiting door. P. Ex. 8, at 1-3; P. Ex. 15, at 16; P. Ex. 21, at 19. This system caused the front door and elevator door to lock automatically when a resident who was wearing the required wristband approached. See P. Ex. 15, at 16; P. Ex. 21, at 19. Petitioner provided a wrist band for each resident identified as at risk for wandering or elopement and who was not on the secured unit. P. Ex. 21, at 19.
Nonetheless, on May 9, 2003, Petitioner had another elopement without staff realizing that a resident was missing. Therefore, in determining whether Petitioner attained substantial compliance prior to June 26, 2003, I focused on what Petitioner did after the May 9 elopement. As determined by Petitioner's investigation, Resident 3 went through an alarmed door on the 800 hall when a family member of a different resident disabled the alarm button. Petitioner placed a protective cover over the alarm button to prevent staff members, residents, and visitors from disabling the alarm. P. Ex. 18, at 2; CMS Ex. 2, at 196. Thereafter, Petitioner relocated the staff member placed at the main entrance so that he or she could monitor both the front door and the 800 hall door. P. Ex. 21, at 2, 19; P. Ex. 23, at 8; see P. Ex. 42, at 14. On May 10, Petitioner deactivated the push buttons that bypassed the alarms on all exit doors that had this feature and established these doors with appropriate signage as emergency exits only. P. Ex. 18, at 1; P. Ex. 21, at 2, 20; P. Ex. 23, at 10.
Petitioner points out that the Facility instituted other measures to prevent elopement. On May 12, 2003, Petitioner contracted a security company to place four security guards on the outside of the building twenty-four hours a day, seven days a week. P. Ex. 9, at 1-2. Petitioner placed the guards based on the suspected exit ways of the eloping residents; i.e., the front door, 800 hallway door, and the patio door on the 700 hall. See P. Ex. 4, at 1. On May 13, Petitioner sent a notification letter to resident family members and responsible parties regarding the safety and security systems to apprise them of the security measures in place. P. Ex. 6, at 1-2. On May 21, 2003, Petitioner had modified the Facility's 500 hall to be used as a second secured unit and most of the additional residents identified as at-risk for wandering and elopement were moved to this unit. See P. Ex. 5, at 28-29; P. Ex. 23, at 12. Additionally, Petitioner points to various in-service training sessions that were held for the staff such as:
Further, Petitioner argues that by May 11, it had resolved the alleged elopement problem by other actions such as making the receptionist staff aware of the notification procedures when they observed residents demonstrating exit-seeking behavior. P. Ex. 23, at 11; P. PreBr. at 27. Additionally, photos of new admissions to the Facility were posted for four days near the staff time clock so that staff would be more attentive to the newly admitted residents' presence or absence. P. Ex. 21, at 3, 21. Supplemental support staff persons were added for monitoring activities throughout the Facility. P. Ex. 21, at 20; P. Ex. 23, at 9. Petitioner also updated the residents' personal alarm bracelets by adding a locking device to the bracelet to prevent residents from removing them. P. Ex. 23, at 11.
On May 20, 2003, the State agency received Petitioner's latest proposed plan of correction. The State agency advised Petitioner on May 27, 2003 that Petitioner's plan of correction was unacceptable as submitted. P. Ex. 20, at 1. I reiterate that my review is de novo and I am not bound by the surveyors' factual or legal conclusions. CarePlex of Silver Spring, DAB No. 1683 (1999). Nonetheless, I note that the State agency expressed the following concerns about Petitioner's plan of correction: the Home Free wireless monitoring system only affected the main entrance and elevator and the plan did not address what the Facility expected to do with numerous other doors; the Facility did not specify how often and who was responsible for checking patio doors or how the checking would be documented; similarly, the Facility did not adequately specify how it planned to monitor the personal watcher bracelets to assure the devices were in place; nor did the Facility address methods of behavior modification or redirection of residents who display elopement behaviors. P. Ex. 20, at 1. I find the State agency's concerns well-founded.
It is clear CMS considered it necessary to actually determine by observation whether Petitioner had implemented all it had alleged and could sustain compliance. Petitioner had previously made claims of improvements that had not been implemented. On April 28, 2003, Petitioner submitted a plan of correction to the State agency and stated that " . . . all actions to remove the immediate jeopardy were completed on or before April 16, 2003," and requested a prompt revisit. P. Ex. 14, at 1. Obviously, Petitioner had not abated immediate jeopardy by April 16 because Petitioner had another elopement on May 9, 2003. Further, as noted above, CMS discovered corrections Petitioner claimed to have made that were not fully implemented on the dates alleged. As examples and as noted above, the receptionist's photo book of elopement-risk residents was out of date, and the application of stickers on the durable equipment and charts of at-risk residents was not completed as of the alleged date.
I also found that Petitioner's evidence of exactly when proposed improvements were implemented is unclear. For example, Petitioner had planned to build fences around outdoor courtyard areas that bordered exits. Petitioner claims that by May 17, six foot high fencing was installed to enclose the outside area of one of the suspected exit routes bordering the 700 and 800 halls. P. Ex. 23, at 11; see P. Ex. 4, at 2. The rest of the proposed fencing, however, was not completed until June 11, 2003. P. Ex. 23, at 11. These inconsistencies suggest to me that CMS was expressing reasonable judgment by insisting that Petitioner be revisited to determine that Petitioner was in compliance with participation requirements.
Importantly, the key item missing from Petitioner's prior anti-elopement system was the staff's attentive supervision of residents given that all four elopements occurred without the Facility staff realizing the residents were gone until so advised by others outside the Facility. While Petitioner claims to have done in-service training by May 22 on tools for recognizing elopement risk behaviors, redirection of residents, proper response to alarms, how to complete 15-minute checks, and the new resident identification program, the only evidence that the staff had actually absorbed and implemented the new training is indicated in P. Ex. 29 which is dated June 18, 2003. A surveyor notes that "[b]ased on interviews with housekeeping, CNAs and nurses, all staff was knowledgeable regarding the identification and care of residents identified as elopement risks." Id.
Installation of Petitioner's proposed new alarm system is another important piece of Petitioner's implementation of an adequate anti-elopement system. Petitioner submitted an amended plan of correction on May 29, 2003 with a corrective date of May 22, 2003, one of the dates when Petitioner now claims it had achieved compliance. P. PreBr. at 21. One of the items that Petitioner proposed in its supplemented plan of correction, in addition to others, was replacing the door alarms with an "updated system that allows keypad monitoring of entrance/exits at particular doors . . . . in the event someone were to exit and an alarm sounds, staff would have to go to the particular exit to deactivate the alarm using the keypad." P. Ex. 21, at 2. The State agency accepted this plan of correction and advised Petitioner on June 2, 2003, that "[a] re-inspection will be conducted at your facility to determine if the cited violations have been corrected in accordance with your plan of correction." P. Ex. 22.
CMS conceded in the SOD for the May 29, 2003 survey that Petitioner had accomplished enough in implementing an adequate elopement prevention plan to abate immediate jeopardy but not to show compliance. CMS noted the following:
CMS Ex. 1, at 21.
Petitioner filed further information with the State agency on June 13, 2003. P. Ex. 23. Again on June 16, 2003, the State agency responded that Petitioner's plan of correction was acceptable and that a re-inspection would be scheduled to determine if the plan of correction had been implemented. P. Ex. 24.
Petitioner argues that the additional items in its plan of correction that were completed by May 22, 2003, were entirely redundant to its compliance. P. PreBr. at 32. I infer from CMS's statements, however, that CMS considered Petitioner's new alarm system as central to Petitioner's allegation of compliance. This is because Petitioner's plan of correction was considered inadequate until Petitioner advised CMS of its proposal and CMS referred to the new system in its May 29 SOD. CMS's determination regarding what actions are required for a facility to correct deficiencies is a matter committed to its discretion and I have no authority under 42 C.F.R. § 498.3 to review it. Even Petitioner does not claim that the new alarm system was installed prior to June 25, 2003. It appears Petitioner had not even obtained a price quote for this system until May 25, 2003. P. Ex. 21, at 42. State agency surveyors noted during the revisit on June 18, 2003, that the new security system was not completely installed. P. Ex. 29. At the revisit on June 26, 2003, the surveyors again noted that the new alarm system had not yet been connected but a shipment tracer indicated the remainder of the system was on its way. P. Ex. 28, at 3-4, 7. The surveyors went to the trouble of inquiring about the status of system parts being shipped to the Facility. Id. It appears the installation of the new alarm system was important to the surveyors in determining Petitioner's compliance and I agree. In a situation of inadequate staff supervision, the "assistive devices" must be effective.
Petitioner has provided insufficient evidence that its staff had fully implemented all the Facility's anti-elopement provisions prior to June 26, 2003. As a result, I conclude that Petitioner failed to prove that it achieved compliance prior to June 25, 2003.
Petitioner was substantially noncompliant with Medicare participation requirements and CMS had a basis to impose the penalty of DPNA on Petitioner from April 25, 2003 through June 25, 2003.
Anne E. Blair
Administrative Law Judge
1. Petitioner contested few of the material background facts in this case. Rather, Petitioner disputed the conclusions CMS drew from the facts.
2. CMS's Statement of Deficiencies alleged additional, non-immediate jeopardy deficiencies (Tag F157 and Tag F309). CMS only circumstantially refers to these other deficiencies in its briefing. CMS PreBr. at 1, 2; CMS Br. at 3, 7. Therefore, I infer that CMS has dropped these alleged deficiencies and I do not address them in this decision. See CMS Br. at 1 (CMS states that the DPNA remedy was imposed "as a result of a deficiency cited under F-324 [42 C.F.R. § 483.25(h)(2)].").
3. The Facility had one secured unit (700 hall) which housed Alzheimer residents and others particularly at risk for elopement. The 700 hall has three exit doors - a main door from the nurses' station, an exterior door located in the patio day room, and an exterior door leading out to the parking lot. P. PreBr. at 15; see P. Ex. 4, at 3. The main door from the nurses' station and the exterior door leading out to the parking lot had a 15-second egress function. Once unlocked and opened, an alarm would sound that would have to be silenced. P. PreBr. at 15.
4. A Facility CNA interviewed by a State agency surveyor reported that Resident 2 could propel his wheelchair and could transfer himself in or out of the chair. CMS Ex. 1, at 62; CMS Ex. 2, at 22.
5. The State agency surveyors referred to this resident as Resident 1 in the May 2003 SOD. Petitioner points out, in footnote one of its brief, that CMS incorrectly refers to Resident 1 from the May 29, 2003 survey as the same person who is identified as Resident 1 from the April 22 survey (who eloped twice in April). Petitioner notes that these residents are in fact two different individuals. P. Brief at 2 n.1; see CMS PreBr. at 3; CMS Br. at 4.
CMS counsel's careless reading of the record is noteworthy, particularly since Resident 1 from the April 22 survey was discharged on April 15, 2003, and therefore, was not even in the facility in May 2003. CMS Ex. 2, at 50. Overall, I found CMS counsel exhibited questionable effort in its litigation of this case, from its limited briefing to its disorganized submission of exhibits.
I will refer to Resident 1 of the May 2003 survey as "Resident 3" in this decision to distinguish him from Resident 1 of the April 22 survey.
6. Petitioner subsequently asserted in its brief that it was in substantial compliance no later than May 11, 2003. P. Br. at 17.