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Department of Health and Human Services DEPARTMENTAL APPEALS BOARD Civil Remedies Division |
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Provena Villa Franciscan, Petitioner, |
DATE: October 26, 2006 |
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Centers for Medicare & Medicaid Services. |
Docket No.C-04-24 Decision No. CR1522 |
| DECISION | |
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DECISION I sustain the determination of the Centers for Medicare and Medicaid Services (CMS) to impose a Civil Money Penalty (CMP) against Provena Villa Franciscan, Petitioner, for failure to comply substantially with federal requirements governing participation of long-term care facilities in Medicare and State Medicaid programs. CMS imposed a per instance CMP of $3,050. I. BACKGROUND This case came before me pursuant to a request for hearing filed by Petitioner on October 13, 2003, in accordance with section 1128(c)(2) of the Social Security Act (Act) and 42 C.F.R. �� 488.408(g) and 498.40. By letter dated September 3, 2003, CMS informed Petitioner that, based on a survey completed August 5, 2003, it was imposing selected remedies due to Petitioner's failure to be in substantial compliance with the applicable Federal requirements for long-term care facilities. The remedies were based on an immediate jeopardy deficiency under Tag F-324. The letter informed Petitioner that CMS was imposing the following remedies:
I held a hearing on October 25-26, 2005. At the hearing, CMS offered 16 exhibits, identified as CMS Exs. 1-16. I received CMS Exs. 1-15 into evidence without objection. I received CMS Ex. 16 into evidence over Petitioner's objection. Petitioner offered 10 exhibits, identified as P. Exs. 1, 2, 6, 7, 11, 12, 13, 15, 16, and 17. I received these exhibits into evidence without objection. Subsequent to the hearing, the parties submitted post-hearing briefs (CMS Br. and P. Br.) and response briefs (CMS Response and P. Response). Based on the testimony offered at the hearing, the documentary evidence, the arguments of the parties, and the applicable law and regulations, I find that Petitioner was not in substantial compliance at the immediate jeopardy level on the date determined by the State survey agency and CMS. I further find that CMS was authorized to impose a per instance CMP of $3,050. II. APPLICABLE LAW AND REGULATIONS Petitioner is considered a long-term care facility under the Act and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act, and at Title 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs and denial of payment for new admissions against a long-term care facility for failure to comply substantially with 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 483 provides that facilities which participate in Medicare may be surveyed on behalf of CMS by State survey agencies in order to ascertain whether the facilities are complying substantially with participation requirements. 42 C.F.R. �� 488.10-.28. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-.335. Under Part 488, a State or CMS may impose a CMP against a long term care facility where a State survey agency ascertains that the facility is not complying substantially with participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The CMP may start accruing as early as the date that the facility was first out of compliance until the date substantial compliance is achieved or the provider agreement is terminated. CMS may impose a CMP for either the number of days a facility is not in substantial compliance with one or more participation requirements or for each instance that a facility is not in substantial compliance, regardless of whether or not the deficiencies constitute immediate jeopardy. 42 C.F.R. � 488.430(a). Thus, CMS may impose a per instance CMP ranging from $1,000 to $10,000 for an instance of non-compliance regardless of whether the deficiency is at the immediate jeopardy level. 42 C.F.R. � 488.438(a)(2). The regulations define the term "substantial compliance" to mean:
42 C.F.R. � 488.301. "Immediate jeopardy" is defined to mean:
Id. In determining the amount of the CMP, the following factors, specified at 42 C.F.R. � 488.438(f), must be considered:
In a CMP case, CMS must make a prima facie case that the facility has failed to comply substantially with 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. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). The Act and regulations make a hearing available before an administrative law judge (ALJ) to a long term 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)(12), (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). III. ISSUES
IV. FINDINGS AND DISCUSSION The findings of fact and conclusions of law noted below in italics are followed by a discussion of each finding.
The applicable regulation at 42 C.F.R. � 483.24(h)(2) entitled "Quality of Care" provides that the facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. Summary of the surveyor findings as reflected in the Statement of Deficiencies (SOD) (CMS Ex. 2, at 3-9). Resident 1 was admitted to Petitioner's secured dementia unit, the Damiano Unit, on June 12, 2003. CMS Ex. 2, at 3-4. His diagnoses included altered mental status and vascular dementia with psychosis. Id. at 3. On June 17, 2003, the facility transferred Resident 1 to a hospital for a psychiatric evaluation related to the Resident's combative behaviors toward staff and other residents. Id. at 4. The Resident returned to the facility on June 24, 2003. Id. A June 30, 2003 Minimum Data Set Assessment (MDS) and Resident Assessment Protocol (RAP) indicated that Resident 1 suffered from severe cognitive deficits and impaired long- and short-term memory. CMS Ex. 2, at 4. The Resident required staff supervision and direction to ensure safe decision-making and was at risk for falls due to the psychotropic medications he was taking. Id. Resident 1 also exhibited daily wandering behavior. Id. The facility assessed Resident 1 as a high elopement risk. CMS Ex. 2, at 3. He had a history of making multiple attempts to leave the facility. Id. An interim care plan from June 24, 2003, stated that he "on occasion look[ed] for a way out." Id. at 4. Resident 1's June 30, 2003 care plan included specified interventions for the Resident's wandering behavior and elopement risk problem. Id. These interventions included the following: (1) "Know [Resident 1's] whereabouts at all times;" (2) "Place in areas where constant observation is possible;" (3) Attempt to divert his attention from the exit doors;" and (4) "Respond to exit door alarms promptly." Id. at 4-5. Resident 1 eloped from the facility on July 19, 2003, at approximately 6:15 pm. CMS Ex. 2, at 3. Nurses' notes indicate that the Resident was upset with his supper and walked out of the Damiano Unit dining room at 6:00 p.m. Id. at 5. All of the Unit's assigned staff remained in the dining room at that time. Id. at 5-6. They did not hear a door alarm. Id. At approximately 6:15 p.m., an agency nurse, Sharon Griffin (Nurse Griffin), left the dining room to check on the Resident. (3) Id. at 5. She could not locate him on the Unit or anywhere else in the facility. Id. Nurse Griffin notified the nursing supervisor and a "Code Green" was called at approximately 6:30 p.m. (4) Id. Nurse Griffin found Resident 1 at approximately 6:45 p.m. CMS Ex. 2, at 5. He was about four blocks from the facility on a heavily traveled street. Id. at 3. The Resident told her that he was going home. Id. at 5. She guided him into her vehicle and drove him back to the facility. Id. The facility could not determine how Resident 1 eloped. Id. at 6. The surveyor's investigation revealed that Petitioner did not comply with certain provisions of its Elopement Risk Policy. CMS Ex. 2, at 6-7. The Policy required that Resident 1's picture be placed in an album at the nurses' station and at the receptionist's desk at the main entrance of the facility. Id. at 6. The receptionist on duty on July 19, 2003 indicated that Resident 1's photograph was not in the album at the time of the elopement. Id. She also indicated that she did not know Resident 1 was a high risk for elopement. Id. The Policy also required the facility's Environmental Services Department to conduct daily checks of the doors' alarms. Id. The maintenance director indicated, however, that Environmental Services did not assess the door alarms daily but checked them once a month. Id. at 7. The surveyor's investigation also revealed possible door alarm malfunctions which may have taken place at the time of Resident 1's elopement. CMS Ex. 2, at 6-8. Maintenance personnel indicated that the Damiano Unit's East and Center corridor exit doors would not trigger an alarm at the receptionist panel because the panel was too full to include them. Id. at 7. Additionally, the facility's Elopement Investigation Tool indicated that the East corridor exit doors were not functioning appropriately on July 19, 2003. Id. at 7-8. Discussion A facility's duty of care under 42 C.F.R. � 483.25(h)(2) is not absolute. Nonetheless, the facility's measures to protect its residents must be adequate and in accordance with the comprehensive resident assessment and plan of care. St. Catherine's Care Center of Findlay, Inc., DAB No. 1964 (2005). Individual resident care plans and general facility policies "represent the facility's contemporaneous assessment of adequate supervision" and are relevant to deficiency determinations under section 483.25(h)(2). Id. at 13. Furthermore, the Departmental Appeals Board (Board) has previously upheld deficiency findings under 42 C.F.R. � 483.25 based on a facility's failure to follow its plan of care since "'[a] care plan is based on a facility's assessment of a resident's needs and represents an interdisciplinary team's best judgment of the services required for the resident, including services required under section 483.25.'" Coquina Center, DAB No.1860, at 21 (2002), citing Cherrywood Nursing and Living Center, DAB No. 1845, at 8 (2002). See also Crestview Parke Care Center, DAB No. 1836 (2002); Asbury Center at Johnson City, DAB No. 1815 (2002). CMS argues that Petitioner failed to provide adequate supervision and assistance devices to Resident 1 because it did not follow Resident 1's care plan and did not follow the facility's Elopement Risk Policy. CMS Br. at 11-12. In particular, CMS contends that Petitioner did not perform the following interventions from Resident 1's care plan:
Id. See also P. Ex. 13, at 3-4. In addition, CMS contends that Petitioner did not check its door alarms daily and did not ensure that its interior door alarms were functional as the facility's Elopement Risk Policy required. CMS Br. at 11-12; P. Ex. 2. Petitioner disputes CMS's interpretation of Resident 1's care plan. It argues that CMS interprets the care plan too stringently and that nursing staff responded appropriately on July 19, 2003. See, e.g., P. Br. at 8-11, 15-19. Petitioner asserts that the Damiano Unit's door alarms were functioning properly at the time of Resident 1's elopement. P. Br. at 21. Thus, according to Petitioner, its failure to test the alarms on a daily basis is immaterial. Id. at 26. Finally, Petitioner also asserts that its failure to place Resident 1's picture in the "wander book" is immaterial because the receptionist was "certain" that Resident 1 did not exit the facility through the front door. Id. at 26-28. Petitioner's arguments are unpersuasive. The record establishes that Petitioner knew Resident 1 was at high risk for elopement and injury if left unattended. See, e.g., CMS Ex. 8, at 133. The June 30, 2003 MDS and RAP narratives noted specifically that Resident 1 required "staff supervision and direction" to ensure his safety. P. Ex. 12, at 12. They also noted that Resident 1 paced around the Damiano Unit, wandered to exits in that unit, and stated that "he [was] going to leave." Id. Resident 1's July 2, 2003 care plan indicated that he did, in fact, attempt to leave the unit. P. Ex. 13, at 3. Nurses' notes documented that he asked how to leave the facility, was "look[ing] for way out," and approached exit doors. P. Ex. 15, at 1-2. The Resident also stated that he wanted to go home. Id. Petitioner's assessments of Resident 1 indicated that the Resident could elope at any moment if given the opportunity to do so. The Resident's care plan recognized this risk. The care plan incorporated references to the Damiano Unit's door alarms, see P. Ex. 13, at 4, but it also specifically required nursing staff to do more than rely solely on the alarms in their supervision of Resident 1. Approaches such as "know [Resident 1's] whereabouts at all times," and "place [Resident 1] in areas where constant observation is possible" indicate that the nursing staff was the first line of defense in the prevention of Resident 1's elopement. Despite the importance of these care plan interventions, the record establishes that nursing staff did not follow them on July 19, 2003. Nurses' notes for that day indicate that Resident 1 walked out of the Damiano Unit dining room at approximately 6:00 pm. P. Ex. 15, at 4, CMS Ex. 8, at 82. At that time, all of the residents on the unit were in the dining room for dinner and a medication pass. Transcript (Tr.) at 142,149. Additionally, all of the staff assigned to the Damiano Unit for that evening were also in the dining room. Tr. at 203-04, 309; CMS Ex. 8, at 125. At the time Resident 1 left the dining room, therefore, nursing staff were not monitoring or observing the other areas of the unit. One nurse, Nurse Griffin, saw Resident 1 leave the dining room. Tr. at 147. Although she knew the rest of the unit was unattended, she decided to finish her immediate task and did not follow Resident 1 out of the dining room. Id. Apparently, she assumed that Resident 1 was going to his "favorite couch." Tr. at 161. Approximately fifteen minutes passed before Nurse Griffin even attempted to discover Resident 1's actual whereabouts on the unit. Tr. at 147-48; CMS Ex. 8, at 83; P. Ex. 15, at 5. Petitioner asserts that Resident 1's care plan did not require nursing staff to constantly observe the Resident. P. Br. at 9-10. Instead, Petitioner argues that the care plan required staff to have "a general knowledge of whether Resident 1 was on or off the unit." P. Br. at 9-10. Thus, according to Petitioner, Nurse Griffin's actions were appropriate under the circumstances. Id. at 10, 14. I disagree. The language of the care plan is clear: "know [Resident 1's] whereabouts at all times," and "place [Resident 1] in areas where constant observation is possible." P. Ex. 13, at 3-4 (emphasis added). Petitioner's own witnesses testified that this language required more than a general knowledge of whether Resident 1 was on or off the unit. For example, Elaine Netcel, a charge nurse in the facility's Stratford Unit, testified that these approaches required nurses to know Resident 1's location on the Damiano Unit itself. Tr. at 291-92, 307. Thus, nursing staff should have known whether Resident 1 was in the dining room, in his own room, or in a common area watching television. Tr. at 291-92. Such an approach is appropriate, moreover, in light of Resident 1's prior attempts to elope from the Damiano Unit. Nonetheless, when Resident 1 left the dining room at 6 pm, nursing staff did not know where he went. Nor did they promptly attempt to redirect the Resident into an area where they could see him, even though they knew the rest of the unit outside the dining room was unattended. Nursing staff's failure to follow the care plan left Resident 1 unattended and unsupervised for approximately fifteen minutes, during which time he managed to elope from the secure unit. Additionally, it is undisputed that Petitioner did not place Resident 1's picture in the "wander book" at the front reception desk, as the Resident's care plan and the facility's Elopement Risk Policy required. (5) Lorri Weeks, the receptionist on duty at the time of Resident 1's elopement, testified that his picture was not in the "wander book." Tr. at 244. Prior to the incident, she did not know what Resident 1 looked like or that he was a high elopement risk. Tr. at 257; CMS Ex. 8, at 27-28. Petitioner argues that its failure to place Resident 1's picture in the "wander book" is immaterial because Ms. Weeks did not see Resident 1 elope through the front door. P. Response at 26; Tr. at 260. Petitioner's argument, however, misconstrues the gravamen of the deficiency. CMS does not have the burden to show how Resident 1 eloped. Under the circumstances of this case, whether the Resident eloped through the front door or through another exit makes no difference. (6) The problem is that the facility knew Resident 1 was a high elopement risk and yet did not follow its own care plan in which it had determined what measures were necessary to protect him. Here, the care plan included the approach that the Resident's picture be in the "wander book." The parties devoted significant argument to the issue of whether the door alarms were operating properly at the time Resident 1 eloped. As I have pointed out in my discussion of the "wander book," however, it is not CMS's burden to show how the resident eloped. Petitioner's point seems to be that, if it can establish that the door alarms were operating properly, then I must conclude that Petitioner was providing all assistive devices that were reasonably necessary to protect Resident 1.
Because the facility was not in substantial compliance with program requirements, CMS has the authority to impose a remedy, and I have no authority to review CMS's choice of remedy; in this case, a per instance CMP. 42 C.F.R. � 488.438(e)(2); 42 C.F.R. � 498.3(b)(13); see also 42 C.F.R. � 488.408(g)(2). Because CMS imposed a per instance CMP, for which the regulations provide only one range ($1,000 to $10,000), the level of noncompliance (i.e. the finding of immediate jeopardy) does not affect the range of the civil money penalty. 42 C.F.R. � 488.438(a)(2). Thus, CMS's finding of immediate jeopardy is not reviewable based on the imposition of the CMP. See Aase Haugen Homes, Inc., DAB CR1273, at 4 (2005), aff'd, DAB No. 2013, at 3 (2006). However, CMS's finding of immediate jeopardy is also subject to review if a finding of substandard quality of care results in the facility's loss of approval to conduct a nurse aide training program. 42 C.F.R. � 498.3(b)(14)(ii). Substandard quality of care is defined to mean:
42 C.F.R. � 488.301. In the present case, CMS concluded that Petitioner failed to comply with 42 C.F.R. � 483.25(h)(2) and that Petitioner's noncompliance was at the immediate jeopardy level. Thus, there was a finding of substandard quality of care, and that finding resulted in the loss of the facility's approval to conduct a nurse aide training program. See CMS Ex. 4, at 4. Accordingly, the finding of immediate jeopardy is subject to my review. The regulations define immediate jeopardy as "a situation in which a 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. A finding of immediate jeopardy does not require "a finding of present harm, but also encompasses a situation that is [likely to cause] harm." Britthaven, Inc., d/b/a Britthaven of Smithfield, DAB No. CR1259, at 29 (2004), citing Hermina Traeye Memorial Nursing Home, DAB No. 1810 (2002). I must uphold CMS's determination of immediate jeopardy unless I find that the determination is clearly erroneous. 42 C.F.R. � 498.60(c)(2). The burden rests on the provider to prove that CMS's determination of immediate jeopardy is clearly erroneous. Petitioner has not met that burden here. Petitioner contends that the finding of immediate jeopardy is not warranted because CMS did not "demonstrate that [Petitioner] failed to provide proper assistive devices and supervision." P. Response at 14. However, I have rejected Petitioner's arguments that it provided Resident 1 with adequate supervision. Moreover, as stated earlier, the record clearly establishes that Petitioner knew Resident 1 was at high risk for elopement and injury if left unsupervised. The facility had documented that Resident 1 paced around the unit, wandered to exits, and stated that "he [was] going to leave." P. Ex. 12, at 13. The care plan reflected that he had attempted to leave the unit. P. Ex. 13, at 3. Nurses' notes documented his practice of seeking an exit out of the facility. P. Ex. 15, at 1-4. Because of Resident 1's high elopement risk, Petitioner determined that it was important for staff to "know [Resident 1's] whereabouts at all times," and "place [Resident 1] in areas where constant observation is possible." P. Ex. 13, at 3-4 (emphasis added). Additionally, the care plan directed that Resident 1's picture be placed in the "wander book" at the front reception desk. In spite of the foregoing, on July 19, 2003, at 6:00 pm, the Resident was allowed to walk out of the Damiano Unit dining room, and enter an area where no staff was present to supervise him. Nurse Griffin, who saw Resident 1 exit the room, waited approximately 15 minutes before attempting to determine his whereabouts. CMS Ex. 2, at 3. The facility's negligence is compounded by the failure to place Resident 1's picture in an album at the receptionist desk at the main entrance of the facility, in keeping with its care plan and policy. CMS Ex. 2, at 6. Furthermore, the facility failed to inform the receptionist that Resident 1 was an elopement risk. Id. The facility's assessment of Resident 1 concluded that he suffered from severe cognitive impairments and impaired long and short-term memory. CMS Ex. 2, at 4. Thus, Petitioner should have foreseen that a failure to provide adequate supervision to Resident 1 was likely to cause that Resident, as well as other residents similarly situated, serious injury, harm, impairment, or death.
When an ALJ finds that the basis for imposing a CMP exists, the ALJ may not: (1) set a penalty of zero or reduce the penalty to zero; (2) review the exercise of discretion by CMS to impose a CMP; and (3) consider any factors in reviewing the amount of the penalty other than those specified by regulation. 42 C.F.R. � 488.438(e). I have found that a basis exists for CMS to impose a CMP because I have found that Petitioner was not in compliance with 42 C.F.R. � 483.25(h)(2). I must, therefore, review de novo whether the amount of the CMP is reasonable by considering the four factors specified in 42 C.F.R. � 488.438(f). These four factors are: (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the scope and severity of the deficiencies, the relationship of one deficiency to other deficiencies, a facility's prior history of noncompliance with reference to the deficiency at issue (factors specified in 42 C.F.R. � 488.404); and (4) the facility's degree of culpability. CMS imposed a $3,050 per instance CMP, which is in the lower range of possible per instance CMP amounts. There is no evidence in the record regarding two of the regulatory factors: 1) the facility's history of noncompliance; and 2) the facility's financial condition. Inasmuch as a single deficiency is at issue here, I cannot consider the relationship among deficiencies. Therefore, the factors that I can consider in reviewing the reasonableness of the CMP are the scope and severity of the deficiency and the facility's degree of culpability. In this case, Petitioner failed to ensure that Resident 1 received adequate supervision and assistance devices to prevent accidents, and such failure resulted in his leaving the facility unsupervised, placing him at risk of serious injury, harm, impairment, or death. These circumstances demonstrate that the deficiency was serious and that the facility bears a certain degree of culpability. In light of these factors, a CMP of $3,050 is not unreasonable. Moreover, the onus is on Petitioner to come forward with evidence, consistent with 42 C.F.R. � 488.404, to show that the amount of the CMP is unreasonable. Petitioner has failed to do so. V. CONCLUSION I conclude that CMS correctly determined that Petitioner was not complying with federal requirements governing participation of long-term care facilities in Medicare and State Medicaid programs at the immediate jeopardy level, and that the imposition of a per instance CMP of $3,050 is reasonable. |
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José A. Anglada Administrative Law Judge |
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| FOOTNOTES | |
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1. The Denial of Payment for New Admissions was no longer in effect as of September 10, 2003. CMS Ex. 6, at 1. 2. Petitioner came into substantial compliance prior to the effective date of the termination of the provider agreement. The CMP based on immediate jeopardy remained the sole issue in this case. 3. The SOD uses the identified "Z2" to refer to Nurse Griffin. 4. The facility's Elopement Risk Policy states that a "Code Green" is called when a door is breached and the door alarm sounds. The receptionist calls the Code Green over the intercom, indicating the location of the breached door. She repeats the call evry 30 seconds until facility staff ascertains the cause of the breach Id. at 6. 5. If an ambulatory resident is at risk for elopement, the facility's Elopement Risk Policy provided that "[A] picture of that resident will be placed at the nurses' station and the reception desk." P. Ex. 2, at 1. As stated above, Approach 10 of the Resident's care plan also indicated that the Resident's picture should have been in the "wander book" at the front desk. P. Ex. 13, at 3. 6. I note that Petitioner's elopement investigation did not reveal exactly how Resident 1 eloped. See CMS Ex. 8, at 119-22. At the time of the hearing, Petitioner still could not explain how Resident 1 eloped from the facility. See, e.g., Tr. at 283, 325. |
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