SUBJECT:

Newton Presbyterian Manor,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

For the reasons stated below, I conclude that Newton Presbyterian Manor (Petitioner or Facility) was not in substantial compliance with Medicare conditions of participation governing nursing home facilities at an immediate jeopardy level on February 19, 2002. Accordingly, I sustain the Centers for Medicare & Medicaid Services' (CMS's) imposition of a per instance civil money penalty (CMP) of $1,000.

I. Background

A. The procedural background

Petitioner is a skilled nursing facility located in Newton, Kansas. Following the Petitioner's self-report regarding an elopement from the Facility, the Kansas Department of Health and Environment (State agency) conducted a survey on February 22, 2002, and, as a result, issued a Statement of Deficiencies (SOD or 2567) alleging a violation of 42 C.F.R. � 483.25(h)(2). CMS set the scope and severity at immediate jeopardy and imposed a per instance CMP of $1,000. Petitioner timely requested a hearing on May 7, 2002. A hearing was held before me in Wichita, Kansas, on August 19-20, 2003. CMS submitted its exhibits, identified as CMS Exhibits (Exs.) 1-7 ⁽¹⁾, and I admitted them into the record. Petitioner submitted its exhibits, identified as P. Exs. 1-61, and I admitted them into the record.

The following persons testified for CMS: State agency surveyor Jackie Kirkpatrick and Myra Aud, Ph.D., a faculty member of the University of Missouri at Columbia, Missouri. The Petitioner presented the following witnesses: Sheldon Klassen, the Facility's Administrator; Angela L. Naysmith, R.N., a charge nurse at the Facility; Heather R. Porter, the former Director of Nursing (DON) at Petitioner's facility; and, Dixie Flynn, a registered nurse and doctoral student at St. Louis University in St. Louis, Missouri.

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 on February 19, 2002, Petitioner was not in substantial compliance with Medicare participation requirements in a way that created immediate jeopardy to its residents. Accordingly, I also find CMS is authorized to impose a per instance CMP of $1,000 against Petitioner.

B. 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 CMPs 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 at 42 C.F.R. � 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 per instance or per day CMP 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, 488.430.

The regulations specify that a CMP imposed against a facility can be either a per day CMP for each day the facility is not in substantial compliance or a per instance CMP for each instance that a facility is not in substantial compliance. 42 C.F.R. � 488.430(a). When penalties are imposed for an instance of noncompliance, the penalties will be in the range of $1,000 - $10,000 per instance. 42 C.F.R. � 488.438(a)(2).

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.

The Act and regulations make a hearing before an administrative law judge (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),(14). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F2d. 678 (8^th 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. United States, No. 98-3789 (GEB) (D.N.J. May 13, 1999). 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.

II. Issues

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 the amount of the CMP imposed is reasonable.

III. Findings of fact and conclusions of law

I have examined closely all of the evidence of record to determine whether Petitioner was complying with participation requirements and to decide whether a CMP may be imposed against Petitioner. I conclude the preponderance of the evidence and the statute and regulations support the finding that Petitioner failed to comply with one condition of participation. I further find that CMS's determination that Petitioner's deficiency created immediate jeopardy is not clearly erroneous and that the CMP imposed is reasonable.

A. Findings of fact - background

I make findings of fact to support my decision in this case and set forth each of my findings below in numbered paragraphs.

1. Resident 1, the only resident at issue in this case, was a 77-year-old woman of slight stature who was moderately impaired from Alzheimer's Dementia. Transcript (Tr.) at 450. ⁽²⁾ Several months prior to the incident in question, she had been living at the Facility in an early dementia security unit in "assisted living" where she had the freedom to come and go. Her cognitive abilities were, however, deteriorating. She could no longer remember her room's location or that she was in a nursing home. Tr. at 22, 93. On January 10, 2002, she was transferred from "assisted living" to Petitioner's Special Care Unit (SCU), a special locked ward at the Facility designed to provide extra protection for residents with dementia. CMS Ex. 2, at 28; Tr. at 28-29, 450.

2. Resident 1's husband resided in Petitioner's Health Care Center (HC), a section of the Facility that was not locked in the same way as was the SCU. After her move, Resident 1's family had requested that she be allowed to eat her meals with her husband. Tr. at 201-02, 382. The SCU and HC corridors could be accessed by the same lobby. The SCU was adjacent to the HC lobby and a locked door separated the two. P. Ex. 10; CMS Exs. 5, 6; Tr., at 32, 119-20. The HC lobby was essentially a hub between three patient care hallways. Tr. at 119. The HC lobby was described as being an open area with a television in the corner and an aviary. The lobby had tables for dining and several recliners for watching television. Tr. at 52. A nurses' station and the Facility's DON office were located immediately off the lobby. P. Ex. 16; CMS Ex. 5; Tr. at 120-21, 149, 157. The Facility used this lobby as a place where Resident 1 and her husband could eat together. Tr. at 45. The Facility did not bring Resident 1's husband into the SCU for meals because Resident 1's husband's behavior was disruptive and created too much stimulation for SCU residents. Tr. at 49, 198. A few other residents also ate their meals in the HC lobby. Tr. at 45.

3. As part of Resident 1's admission to the SCU, Petitioner assessed her and Petitioner identified her as an aimless wanderer and a possible elopement risk. Tr. at 93, 377, 450. ⁽³⁾ The Petitioner devised a care plan for her on January 24, 2002, that addressed her wandering as an identified problem and Petitioner instituted interventions to prevent it. P. Exs. 25, 36; Tr. at 25, 456. Although she was assessed as an aimless wanderer and had wandered into the rooms of other SCU residents, prior to February 19, 2002, Resident 1 had never attempted to exit the building. Tr. at 68, 377.

4. Petitioner's measures to prevent elopement by at-risk residents included the following. The Facility doors were equipped with alarms that required a code entered on a keypad to open the door. Tr. at 163. Additionally, the Facility used a personal alarm system with residents who had been assessed as an elopement risk. The personal alarm system involved the use of alarm bracelets or anklets placed on the resident. The alarm was designed to sound if the wearer attempted to pass through a door that had been equipped with an alarm trigger. In addition to the actual door alarm, the Facility had placed alarm triggers near the door for those residents who were wearing the bracelet or anklet. Tr. at 164, 166. One keypad near the doors was used to disarm the wander alarm and one keypad was used to disarm the door. At each egress, the Facility used the same code for the door's keypad and the residents' personal alarm keypad but the key codes were not the same for all egresses into and out of the Facility. Tr. at 221. Also, the Facility had a Guardian Alarm System as a "backup" in case the door alarms were not working and could not be immediately repaired. Tr. at 162-63. Additionally, the Petitioner employed a 30 minute visual check system for residents assessed at risk. The Facility also had an "elopement notebook" with the name, photograph, and responsible party for the at-risk residents. Tr. at 195.

5. As part of Petitioner's elopement prevention plan for Resident 1, Petitioner placed a personal alarm device on her ankle. CMS Ex. 2, at 28; Tr. at 181. Her physician's order for the device, dated January 10, 2002, required the Facility to check daily for the device's placement on her ankle and it was to be checked weekly for functioning. Id. Additionally, her care plan provided that she was to receive 30 minute visual checks. Id. Her name, photograph, and responsible party were included in Petitioner's elopement notebook. Tr. at 195.

6. On February 19, 2002, Resident 1 ate dinner with her husband in the HC lobby which was her normal routine. Tr. at 46, 233, 379. That evening Angie Naysmith was charge nurse for both the HC and SCU. Tr. at 236-37. At 6:15 p.m. and 6:45 p.m., Ms. Naysmith observed Resident 1 in the HC lobby. Tr. at 59, 60, 80, 123, 233, 235. At 7:00 p.m., Debra Lazarro, a certified medication assistant for the Facility, opened the door between the SCU and the HC lobby and she observed Resident 1 in the lobby. CMS Ex. 2, at 34; Tr. at 60-62, 123-24, 387.

7. Sometime between 7:20 p.m. and 7:30 p.m., two Facility certified nursing assistants (CNAs) were returning to the HC after a meal break. They were walking along an enclosed hallway between two of the Facility units. The hallway had windows all along the corridor. One of the CNAs looked out of a window and saw Resident 1 in the front - or south - yard of the Facility. P. Exs. 37, 46; Tr. at 77. The CNAs immediately brought Resident 1 back into the building. Tr. at 178.

8. When Resident 1 was found, the staff noted that her clothing was not torn, soiled, or wet. P. Ex. 37; Tr. at 252-53. Her glasses were still on. The staff concluded that she had not fallen when she was outside. Tr. at 67. The CNA who discovered Resident 1 outside, nonetheless, had described Resident 1's skin as very cold and Resident 1 looked like she had been crying. P. Exs. 34, 46. Resident 1 was wearing her personal alarm anklet when she was found. Tr. at 67. No staff member had heard an alarm sound, however, when she left the building. P. Ex. 34; Tr. at 175.

9. Upon Resident 1's return, the Charge Nurse, Ms. Naysmith, assessed Resident 1's physical condition. P. Ex. 34; Tr. at 178, 241, 247. Resident 1 had no signs of bleeding, bruising, or injury. She denied any pain or injury. P. Ex. 34; Tr. at 250. When Resident 1 was found, however, she handed one of the CNAs a tooth. P. Ex. 36, at 3; Tr. at 247. Her mouth was examined and there was no indication that the tooth was hers or that it had come out during that evening or when she was outside. P. Ex. 36, at 3; Tr. at 66, 67, 247-48. Although Resident 1 was noted to have "fading purple bruises" on her the next day, staff concluded the bruises could have been unrelated to her elopement. CMS Ex. 1, at 3-4; P. Ex. 33, at 6. Resident 1 was using both Plavix and aspirin which act as blood thinners and can exacerbate bruising. P. Ex. 24, 26; Tr. at 249, 393.

10. After Resident 1 was returned to the building, the staff began an investigation. P. Ex. 36. Ms. Naysmith notified Resident 1's physician, family, and the DON regarding the elopement. P. Ex. 33; Tr. at 179, 255. The staff checked other residents who were at risk for wandering as well as their personal alarm bracelets and identification bracelets. Tr. at 179, 243. The staff also checked the door and personal alarm systems to make sure they were operating properly. P. Exs. 35, 36; Tr. at 243.

11. When the CNAs escorted her into the Facility building, Resident 1's alarm anklet activated the alarm in the hallway south of the HC lobby. P. Ex. 36; Tr. at 239, 241-42. With one exception, all of the Facility's door and personal alarm systems were functioning and operational. P. Ex. 36; Tr. at 179-80, 213-14, 245. The personal alarm system at the north door of the HC lobby when tested, however, emitted only two or three short "beeps" and then shut off. If functioning properly, the alarm would have sounded until staff reset the alarm. P. Exs. 34, 35; Tr. at 73-75, 174-75. After the Facility staff discovered the alarm malfunction at the north door, the staff activated the "backup" Guardian Alarm System and locked down the SCU. Tr. at 163, 185, 245-46. Over the next several days, the alarm at the north door was repaired. P. Ex. 9; Tr. at 74, 173-75, 180, 185-86.

12. Resident 1 was unable to say how she had left the building or why, except to "look for her car." P. Ex. 36. The Facility did not reach any definitive conclusion about how Resident 1 left the building. Tr. at 179.

13. On February 20, 2002, Petitioner notified the State agency of the occurrence. P. Exs. 36, 37. The Facility changed Resident 1's care plan to provide that she eat all of her meals inside the locked SCU. P. Ex. 36. Additionally, the Facility adopted a plan for checking the anklets and bracelets of residents at high risk of elopement and the door alarms. The Facility conducted in-service training for unwitnessed exit precautions and prevention techniques. P. Ex. 36; Tr. at 184.

14. On February 22, 2002, the State agency conducted an abbreviated survey of the Facility, and determined the Facility was not in compliance with federal participation requirements. CMS Ex. 1. The State agency issued a SOD for the single incident of Resident 1's elopement, determining a severity level of immediate jeopardy. Id. The State agency found deficiencies under F-tags 698 (past noncompliance) and 324 (lack of adequate supervision and assistance devices to prevent accidents). ⁽⁴⁾ Id. On March 15, 2002, CMS notified Petitioner that CMS concurred with the recommendation of the State agency and imposed a $1,000 per instance CMP. On May 7, 2002, Petitioner filed its request for hearing.

B. Conclusions of fact and law

1. The preponderance of the evidence is that Petitioner failed to comply substantially with federal requirements of participation.

Section 483.25 of 42 C.F.R., entitled "Quality of Care," provides that "[e]ach resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and care plan." A subpart of this regulation at 42 C.F.R. � 483.25(h)(2) relates to accidents and requires each facility to "ensure that each resident receives adequate supervision and assistance devices to prevent accidents."

The standard to be considered in elopement and accident cases is generally expressed as a statement that the regulations do not require a facility to be free of all accidents; strict liability is not assigned to a facility for accidents a resident may sustain. In cases, however, concerning a facility's compliance with 42 C.F.R. � 483.25(h), the focus is on the affirmative duty of the facility to ensure that each resident receives adequate supervision to prevent accidents. While a facility is not required to do the impossible or be a guarantor against unforeseeable occurrences, the facility is required to do everything in its power to prevent accidents. While not strict liability, the fact that an elopement or accident actually occurred tends to show that the facility did not do everything in its power to prevent its occurrence. This is particularly true if the facility has foreseen the potential for a resident's accident or elopement. Stated in a slightly different way, the facility is obligated to take measures that are designed, to the extent that is practicable, to ensure that residents do not sustain accidents that are reasonably foreseeable. See Koester Pavilion, DAB No. 1750 (2000); Woodstock Care Center, DAB No. 1726 (2000) aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6th Cir. 2003). My decision in this case is based on whether Petitioner took measures, to the extent practicable, to ensure that Resident 1 did not elope, given Petitioner's recognition that Resident 1 was at risk for elopement. The regulations do not require that a facility use any particular system to prevent elopements. Using an outcome-oriented approach, facilities have the flexibility to use a variety of methods, but they are responsible for achieving the required results. Woodward Hills Nursing Center, DAB CR991 (2003).

Petitioner argues that the facility had systems in place to provide appropriate supervision of Resident 1, such as alarmed doors, as well as a personal alarm which Resident 1 was wearing when she eloped. Petitioner also argues that the facility did 30 minute visual checks of Resident 1 and that when Resident 1 ate in the HC lobby she was highly visible to staff. Tr. at 15. Petitioner points out that Resident 1 was not injured in any way and the facility had no notice of any problems with its procedures and systems in place. Tr. at 18. As explained in more detail below, I do not find Petitioner's arguments to be persuasive.

In this case, Petitioner had planned the following actions to prevent Resident 1's elopement. First, Petitioner placed a wander guard on Resident 1 so that her attempts to pass through a door to the outside would trigger an alarm. Second, as part of its supervision, Petitioner planned to have a staff person visually check the resident's whereabouts every 30 minutes. Had just one of these practicable measures been adequately implemented on the night in question, it is unlikely Resident 1 would have been able to elope.

a. Petitioner failed to ensure that its anti-elopement alarms were in working condition.

One of Petitioner's plans for residents who were elopement risks was to apply personal alarms on such residents. An alarm was placed on Resident 1's ankle and it was on her and operational when she was found outside. The band's placement was to be checked daily and the function was to be checked every week. P. Ex. 26, at 1. Based on some of Petitioner's documentation, however, it is not clear that the ankle band was checked every day nor its functioning checked every week. See P. Ex. 28; Tr. at 224. Resident 1's anklet bracelet, nonetheless, was in place and appeared to be working at the time of her elopement.

More problematic is the fact that the north door anklet alarm was not working at the time of Resident 1's elopement. Petitioner's staff was charged with checking the door alarms every day, every shift; i.e., three times per day. Petitioner's documentation concerning these checks contains gaps. P. Ex. 1. Based on this documentation, one could conclude that no one checked the door alarms on any shift from February 13, 2002 until after Resident 1 eloped on February 19, 2002. Id. Although the charge nurse, Angie Naysmith had initialed the door alarm check sheet for her shift of from 2:00 p.m. to 10:30 p.m., I infer from her testimony that door alarms had not been checked prior to Resident 1's elopement. See Tr. at 242 (after the elopement she thought she needed to know whether the anklet bracelet and door alarms were working); Tr. at 243 (checked the doors after assessing Resident 1).

Petitioner's investigation after Resident 1's elopement confirmed that the HC lobby anklet alarm trigger on the north side was malfunctioning; i.e., emitting three tones and then resetting. Tr. at 176, 180. ⁽⁵⁾ Although Petitioner's investigation provided no definitive answer as to how Resident 1 exited the Facility, Petitioner's Administrator Klassen opined that it was unlikely Resident 1 exited the north lobby door with the faulty anklet alarm because of the distance Resident 1 would have had to cover to the spot where she was found in the relatively short amount of time she was outside the building. Tr. at 179, 187-89. He suggested that, because Resident 1 was found outside the south door of the Facility, a guest or visitor may have punched the correct code number into the key pad to deactivate the door alarm and Resident 1 simply followed the person out. Tr. at 191-92, 230.

To conclude that Resident 1 exited the Facility on the south side may be preferable to Petitioner because such a conclusion would assign the entire cause of Resident 1's elopement to the unintended acts of visitors and would suggest a shorter time period of Resident 1's absence. The Facility's faulty alarm and haphazard system of checking alarms, doing visual checks on Resident 1, and supervising her - which I discuss later herein - would have made no contribution to her exit.

I conclude that the more logical explanation for Resident 1's elopement is that she wandered out of the Facility on the north side and walked eastward around the building to the south. I conclude this for a number of reasons. First, I think that a visitor who was knowledgeable enough about the Facility to know the south door alarm keypad code would also know he or she did not have to deactivate the anklet alarm to exit the door. There would have been no reason for a visitor to think the anklet alarm - a separate keypad - would have to be deactivated. Second, when Debra Lazarro opened the SCU door into the HC lobby, she saw Resident 1 without her husband. Ms. Lazarro asked Resident 1 whether she was ready to return to the SCU. Ms. Lazarro described her observation as follows:

The last time I saw [Resident 1] she was sitting at the table in HCC. I had ask [sic] her if she was ready to come back to SCU or to her room. She'd [seen] her husband coming down the North hall and [Resident 1] said, "well here he comes" so I told her I'd let her stay and visit him.

CMS Ex. 2, at 34. Ms. Lazarro does not say that she herself saw Resident 1's husband coming down the hall. It seems logical to me that Resident 1 could have wandered toward the north hall, saw someone going out the lobby door on the northwest side and followed them. Because the anklet alarm at that door was not working, she was able to leave the building without an alarm sounding. Third, according to Petitioner's post-elopement investigation, Resident 1 had stated to the CNAs that found her that she was looking for her car. P. Exs. 36, 37. A schematic of the Facility shows a parking lot outside the north door. CMS Ex. 6; see also Tr. at 187, 242. Although an assumption about the thought processes of a person with Alzheimer's dementia is not foolproof, I see a possible connection between Resident 1's saying she was looking for her car and passing a parking lot. Fourth, based on my review of the schematic of the Facility and the relative distances from Petitioner's photographs, I conclude that Resident 1 could have walked around the building on the east side of the Facility from the north to the south doors in 15 to 20 minutes. CMS Ex. 6; P. Exs. 13, 22. I find, therefore, it entirely plausible that Resident 1 left the building through the north door, following a visitor or staff person who had deactivated the door alarm, and that the faulty anklet alarm at the door allowed her to exit without an alarm sounding. Because no alarm sounded, it is highly unlikely that Resident 1 exited any of the other doors in the Facility. P. Ex. 34; Tr. at 230-31, 359-61. ⁽⁶⁾ Had the north door anklet alarm been checked in the shift prior to Resident 1's elopement, it is unlikely Resident 1 would have eloped.

It is Petitioner's responsibility to show it was in compliance. The Facility had a faulty north door alarm and has submitted evidence insufficient for me to conclude that Petitioner's staff checked the anklet alarm at the north door during Ms. Naysmith's shift prior to Resident 1's elopement on February 19, 2002.

b. The Facility's implementation of its every 30 minute visual check system did not work for the times when Resident 1 was eating dinner in the HC lobby.

The evidence shows that the Facility's staff was unclear as to whose responsibility it was to do and/or to chart the 30 minute visual checks of Resident 1 required by her care plan when Resident 1 was in the HC lobby eating meals with her husband. Tr. at 36, 38-39; 405-09. What the SCU staff understood was that, while Resident 1 was in the HC lobby, the HC staff would do the 30 minute visual checks. Then, after Resident 1 returned to the SCU, the SCU staff charted that the visual checks had been done. Id. ⁽⁷⁾

I find this to be a problematic after-the-fact way to chart the visual checks. In essence, the SCU could chart only that Resident 1 was returned safe and sound from her meals. The SCU staff could not chart that 30 minute visual checks had been done if the SCU staff had not done the checks. Both CMS's and Petitioner's witnesses testified that it is better nursing practice for the person who does the activity to be the person who charts it. Tr. at 260, 407.

Petitioner argues that there was overlap in staff between HC and SCU and enough communication between them that formal charting every 30 minutes was unnecessary. Tr. at 389-90. Petitioner also pointed out that the Facility often used only one charge nurse for both units, as was the case on February 19, 2002. The charge nurse for HC and SCU on the evening of February 19^th, Angie Naysmith, was ultimately responsible for Resident 1's whereabouts whether Resident 1 was at HC or the SCU. Tr. at 405. Petitioner also contends that, because there were so many staff members wandering around and through the HC lobby that strict 30 minute visual checks were unnecessary. In fact, Angie Naysmith later stated that she had seen Resident 1 at 6:15 p.m. and at 6:45 p.m. P. Ex. 34. ⁽⁸⁾

In her testimony, the DON was ambiguous about whether the Facility's charge nurses actually assigned to a specific CNA each day the responsibility of doing and charting visual checks of Resident 1. The DON explained that the charge nurse would only "at times," varying among the charge nurses, assign to a specific CNA or CMA the responsibility of doing and charting the 30 minute visual checks of Resident 1. Tr. at 406. The charting was to be done at the time of the visual check and not later or at the end of the shift. Tr. at 407. The DON admitted that, "I don't believe on this particular resident that it was assigned by the charge nurse in Health Care, that she assigned a CNA in Health Care to do that. She took that responsibility when she came over for those brief 30 to 45 minutes to eat the meal." Tr. at 407. Yet, it was the responsibility of the SCU staff to chart her whereabouts at some later time. Tr. at 408. According to the DON, "When [HC] returned her, it was obvious that they had checked on her for those visual checks." Tr. at 409.

The problem with Petitioner's method is that, after Resident 1 was returned to the SCU, it wasn't obvious the visual checks had been made, it was only obvious that Resident 1 had not disappeared. See Tr. at 415. After this incident, the Facility's policy changed such that the check sheet went with the person who had left the SCU. The charting also required a notation as to where the resident was seen. Tr. at 390; Ps. Exs. 31, 32.

I conclude that the Facility's method of doing its visual checks of Resident 1 when she was in the HC lobby did not provide her adequate supervision, given her known condition and risk for wandering. It was an important element of "supervision" of Resident 1 that someone have responsibility for her whereabouts. When Resident 1 was out of the SCU, it was important that she have more, rather than less, monitoring due to the visitors in the area and the staff being involved in other duties at mealtime. Tr. at 35. Resident 1 may have been visible to many staff members while she was dining in that area, but if no one HC staff member was responsible for her presence or absence, her absence would not be noticed. If no HC staff person was responsible for knowing whether Resident 1 had returned to the SCU, the HC staff would naturally assume she had returned to SCU if she were no longer in the lobby, particularly if her absence was at the end of dinner time, as it was on February 19, 2002. In the HC, the evening meals were served at 5:30 p.m. and were generally concluded within a half hour to 45 minutes. Tr. at 182. There is no record evidence that an official hand-off of responsibility for Resident 1's care was arranged between SCU and HC staff. As a result, no one from HC would have made any particular note of Resident 1's absence. The HC staff had no reason to think that Resident 1 would not be absent from the lobby after 7:00 p.m.

Moreover, even if Petitioner had actually visually checked for Resident 1 every 30 minutes, the facility staff failed to go the next step and "supervise" Resident 1, a requirement clearly stated in the regulations. Tr. at 35. As noted above, Ms. Lazarro from the SCU looked into the HC lobby at 7:00 p.m. and spoke with Resident 1. Resident 1's husband was not with her at that time. Ms. Lazarro asked Resident 1 whether she wished to return to the SCU. Resident 1 indicated that she saw her husband coming down the hall and the staff member told Resident 1 she could remain in the lobby longer to chat with her husband. Ms. Lazarro did not check to see whether, indeed, Resident 1's husband was coming down the hall. Nor did Ms. Lazarro find either the charge nurse, Ms. Naysmith, or another staff member in the HC lobby to indicate that Resident 1 still needed attention, i.e., supervision, in the lobby, and had not returned to the SCU. Tr. at 83. Because of Petitioner's system and the time, 7:00 p.m., any staff member in the lobby would have assumed that Resident 1 was absent because she had returned to the SCU.

Ms. Naysmith, the charge nurse, who reported later that she had seen Resident 1 at 6:30 and 6:45 p.m. that evening, testified she had finished monitoring the dining room, done some charting, and then a little before 7:00 p.m. she went to supper. Tr. at 233. Her practice was to have dinner with her own husband and small daughter in the quiet room just off from the HC lobby. Id. at 234. On the evening in question, Ms. Naysmith was the charge nurse for both HC and the SCU, but she did nothing to assure that a staff person was supervising Resident 1 before she went to supper. Tr. at 237. Petitioner contends that because Ms. Naysmith had last seen Resident 1 at 6:45 p.m., no visual check was required until 7:15 p.m. Further, according to Petitioner, Resident 1 was found by 7:20 p.m. when she would have been noticed as missing by Ms. Naysmith. I conclude, however, that there is no evidence Ms. Naysmith would have interrupted her supper break with her family to do a visual check of Resident 1 at 7:15 p.m. Tr. at 260, 396-97. More importantly, it is unlikely Ms. Naysmith would have found anything unusual about Resident 1's absence. She would have assumed, as did the rest of the HC staff, that Resident 1's absence meant she had returned to the SCU. It was simply fortuitous that two staff members saw Resident 1 in the south yard and returned her to the facility.

Further evidence that Petitioner's system of supervising Resident 1 was inadequate is contained in the testimony of Dr. Myra Aud, an assistant professor of nursing who testified on behalf of CMS. She found an inconsistency in the way Petitioner's visual checks were done and documented when Resident 1 was in the HC lobby and out of the SCU. Tr. at 98. She also testified that it is inappropriate for nursing personnel to indicate on a chart that he or she had done a visual check when, in fact, someone else had done the visual check. Tr. at 101, 129, 143. Rather than more loosely following procedures when Resident 1 was out of the SCU, according to Dr. Aud, the facility should have done additional and compensating monitoring because when Resident 1 was in the HC lobby, the precautions for keeping her safe had been reduced and additional procedures were called for. Tr. at 102. Dr. Aud further testified that demented individuals are drawn to doors which are often, as a result, camouflaged in home care settings. Tr. at 104. Moreover, it is common behavior for people with dementia to shadow other people. Tr. at 140.

Petitioner also presented an expert witness, Dixie Flynn, a Ph.D. candidate at St. Louis University, who is an R.N. and has been a certified nursing home administrator. Tr. at 449. Her testimony can be summarized as saying that the HC lobby was an intimate area in which residents could be easily seen. Tr. at 454. She also noted that her review of the records confirmed that Resident 1 was not injured as a result of her elopement. Id. at 454-56. She also stated that because of the relatively smaller size of the facility, there was interaction and communication between the HC staff and the staff of the SCU. Tr. at 460. She disagreed with Dr. Aud that it is inappropriate for nursing staff to delegate charting to another member of the staff and that it is common for charting to be done well after the activity in a nursing home setting. Tr. at 464-65. Nonetheless, she later conceded that it would be her preference that a staff member document his or her own activities and that nursing guidelines concur. Tr. at 465-66, 475, 485. She noted that it is not possible for a facility to provide 24 hour a day, one-on-one supervision to a particular resident. Tr. at 466.

My difficulty with Ms. Flynn's testimony is that even if the HC lobby was a small area in which residents could easily be seen, there was no one staff person who was specifically charged with accepting responsibility for Resident 1, a hand-off when she left the greater security of the SCU, and would note her absence. Moreover, there is no evidence that an HC staff member was assigned to stay in the lobby area so a staff person could have seen Resident 1 leave if she had chosen to do so. Tr. at 116-17. I also note that even though Resident 1 was not injured as a result of her elopement, the potential for more than minimal harm is patent. There is no evidence Resident 1 could maneuver streets or other hazards or that she could find her way back once she had wandered away. I concede it is not possible for a facility to provide 24 hour a day, one-on-one supervision to its residents. This inability to continuously monitor is why facilities have special locked units. When a resident known to wander is out of the locked unit, however, more supervision is required. Every 30 minute visual checks could amount to satisfactory supervision while Resident 1 was in the SCU but was not adequate supervision when she was in the HC lobby, particularly when no one staff person was assigned responsibility for doing those checks.

Of course in this case, Petitioner had an alarm system as an assistance device and the anklet alarm was properly placed on Resident 1. The regulations, however, require that residents receive both adequate assistance devices and supervision. In this case, Resident 1 clearly received inadequate supervision. The reason why alarms are known to be insufficient alone to prevent elopement from long-term care facilities is because they can malfunction and because they are disarmed from time to time by staff and visitors. Tr. at 80, 105, 107. Supervision is also required. I conclude that when Resident 1 was in the HC lobby area, she required more - not less - supervision. She should not have been left alone in an area where neither the staff nor visitors would have expected a person from the SCU to wander through a door to the outside. Moreover, visitors to the Facility often had access to the codes for disarming the north and south exit doors. The access code was posted on the outside of the door (Tr. at 218) and there was no formal program in place to advise visitors to be careful about who exits with them. Id. Without adequate supervision while Resident 1 was in the HC lobby, a simple malfunction in an alarm could lead to an elopement. As a result, I conclude Petitioner was not in substantial compliance with 42 C.F.R. � 483.25(h)(2) on the night of February 19, 2002.

2. CMS's classification of immediate jeopardy for Petitioner's substantial noncompliance is not clearly erroneous.

In this case, CMS assigned a scope and severity level to the cited deficiency as isolated and posing a risk of immediate jeopardy to the residents. As noted above, CMS assessed a per instance CMP of $1,000. 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).

A per instance CMP can be from $1,000 to $10,000. There is no specifically defined range of per instance penalty for findings of immediate jeopardy. 42 C.F.R. � 488.438(a)(2). Thus, a finding of immediate jeopardy can have no effect on a range of penalties. If CMS has assessed a per instance CMP, the only way CMS's assessment of immediate jeopardy can be an appealable initial determination, herein, is if the finding of substandard quality of care will affect the Facility's nurse's aide training program. Neither party in this case submitted evidence that Petitioner has a nurse's 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's 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 noncomplaince 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, Resident 1 did not suffer serious harm or injury as a consequence of her elopement. When Resident 1 was discovered by Facility staff members and was returned to the Facility, she had not been outside for a long period of time, perhaps 10-20 minutes. She was, nonetheless, cold, tired and short of breath. Tr. at 44. The fact that she did not suffer more injury is simply good luck. It is hard to imagine an elopement, for even a short period of time, by an elderly resident who suffers from Alzheimer's dementia at even a moderate level, that fails to present the likelihood of serious injury, particularly on a midwestern winter night.

3. The amount of the per instance CMP assessed against Petitioner, $1000, is reasonable.

A per instance CMP can be from $1,000 to $10,000. CMS imposed the lowest possible per instance CMP against Petitioner. Because CMS has proven, by a preponderance of the evidence, that Petitioner was substantially noncompliant as alleged, I cannot change the type of penalty that was assessed, and I cannot find that the CMP of $1,000 is unreasonable. 42 C.F.R. �� 488.408 (g)(2), 488.438 (a)(2).

4. I find no impropriety in Petitioner's handling of documents as alleged by CMS.

CMS devoted over eight pages of its post-hearing brief to its concerns that Petitioner had altered or backdated some of its documents. Earlier, on March 6, 2003, CMS requested Petitioner to produce documents or witnesses to explain the alleged discrepancies. Thereafter, on July 18, 2003, CMS moved for an Order to compel Petitioner to provide the requested information by way of an issued subpoena. On August 1, 2003, because I found CMS's request to be over-broad and burdensome, I denied CMS's request but permitted CMS to address these documents during its cross-examination of Petitioner's witnesses. CMS now complains that because the requested subpoena was not issued, "the employees at the facility who knew the circumstances surrounding the documentation of monitoring of the resident during the time of the elopement and the documentation of the alarm system checks were never identified." CMS Br. at 19. CMS requested either an "adverse inference rule" or in the alternative, CMS asked that the record be re-opened, the subpoena issued and the hearing reconvened.

CMS first noted that CMS Ex. 2, at 51 [other copies at P. Ex. 30 and the original at P. Ex. 60] had handwritten initials "HC" written over the initials "DL" in the critical 30-minute time blocks for visual checks on the evening of February 19, 2002. I find the document in question did have D.L. for Deb Lazarro on it for the checks that were being done in HC and that later someone wrote "HC." over Ms. Lazarro's initials, with the HC referring to the Health Care Center's staff. Tr. at 85. CMS asked that I apply an "adverse inference rule" because the facility made no explanation for the alleged alteration. Id. In particular, with respect to P. Ex. 60, CMS asked that I infer that no one on the facility's staff was willing to put their initials on the document because they did not know whether or not observations of the resident had been made during the critical time periods. According to CMS, if staff did not know whether observations had been made at 6:00 p.m. or 6:30 p.m., it would suggest that adequate supervision had not been provided.

I agree with CMS that the alteration does show that Petitioner's staff was confused about who was to make the 30 minute visual checks of Resident 1 and how the checks were to be documented. Tr. at 85. The chart had not previously been documented in this fashion. Tr. at 86; P. Ex. 60. Moreover, we can assume that D.L. did not regard her conversation with Resident 1 at 7:00 p.m. to be a documentable visual check as someone continued to refer to HC as the responsible party at 7:00 p.m. the night of February 19.

I do not find, however, that this handwritten change reflects anything particularly nefarious on Petitioner's part. With regard to the red HCs placed on P. Ex. 60, the DON testified that management did not direct that the HC be placed on the chart. Staff told her that they wrote the HC to denote Health Care staff. After the incident the staff were in-serviced and told the initials on the charts should be "their initials verifying that they had actually seen the resident at that time, not where the resident was." Tr. at 399.

With respect to CMS Ex. 2, at 25, concerning the alleged backdating of the alarm check sheet, CMS asked that I infer that the "post-survey placement of initials for supposed pre-survey checks was intended to be misleading" which would, according to CMS, be relevant to the credibility of its witnesses and the accuracy of its documents. CMS Br. at 12-13. With regard to the comparison between CMS Ex. 2, at 25 and P. Ex. 1, at 1, a reasonable assumption can be made that when the facility gave the copy of the door alarm check sheet to the surveyors, the facility continued to use the original check sheet. Whether or not an adverse inference is required, it is clear, based on P. Ex. 1, that the staff member who charted put in a late entry for both February 12^th and February 19^th without indicating that it was a late entry, a system not in accord with the Facility's policy. Tr. 209-10, 423-24. Again, I do not conclude anything nefarious on Petitioner's part about these documents. I do think this supports my conclusion that there was confusion about elopement prevention responsibilities on the night of February 19^th. I note that Ms. Naysmith testified but CMS asked her no questions about whether she checked any of the door alarms or knew whether anyone on her staff had checked the door alarms prior to Resident 1's elopement on February 19, 2002.

CMS also complains about P. Ex. 25, at 2, with respect to handwritten notes adding interventions to Resident 1's care plan after she eloped. CMS argues these notes were written on the document and undated in order to suggest to the surveyors that the interventions had been part of Resident 1's care plan since January 24, 2002. The DON credibly testified that, as part of her five-day investigation of the elopement, she made the handwritten entries on P. Ex. 25, page 2 on February 20, 2002, to record interventions already in place for Resident 1 of 30 minute visual checks, weekly checks on her personal alarm and redirecting activities when wandering. She explained that when the surveyors were reviewing Resident 1's care plan and asked who put in the handwritten entries, she dated the entries as having been made on February 20, 2002. She said the noted interventions had been in place but had not been put on the care plan. Tr. at 400-03. I find nothing intentionally misleading about the DON's actions. She had been the DON for only a few days. She was in the middle of a survey and she was trying to respond to the surveyors' concerns. Other documents confirm that the 30 minute visual checks and weekly checks on the alarm anklet had been in place prior to the elopement. The late notations do suggest some sloppy paperwork on the part of the facility but not, in my opinion, an attempt to hide evidence. I point out, in addition, that the DON appeared at the hearing and CMS had an opportunity to cross-examine her.

In conclusion, I find no cause for making any adverse inferences that could not be naturally made by reviewing the documents in question. Nor do I find that the documents show any intent by Petitioner to mislead either CMS or this tribunal. I decline to reopen the record in this case.

IV. Conclusion

I sustain CMS's determination against Petitioner that it was not in substantial compliance at the immediate jeopardy level on February 19, 2002, and the imposition of a per instance CMP in the amount of $1,000.

Anne E. Blair

Administrative Law Judge

1. Attached to its post hearing brief, CMS submitted Ex. 7 which has been renumbered by me as Ex. 8 and, there being no objection filed from Petitioner, was admitted into the record.

2. To protect her privacy, Resident 1's name is not used herein.

3. Petitioner used the term "aimless wanderer" for residents in the lower to middle of the continuum which included individuals with no risk of wandering to high risk of elopement. Tr. at 378.

4. Because F-tag 698 is a derivative citation from F-tag 324, I discuss only F-tag 324 in this decision.

5. Petitioner's Administrator Klassen testified that, even though no testing was documented, he had no reason to believe the checks of the alarms were not made. Tr. at 169-70. On the contrary, I conclude the more rational supposition is that the checks were not made. When alarm checks had been previously documented, one can assume that the absence of documentation equates with the absence of checks.

6. I also considered whether Resident 1 may have left by way of the door at the end of the north hall from where, as she told Ms. Lazarro, she saw her husband approaching. Resident 1 may have wandered down the north hall to find him. As explained by Administrator Klassen, the north hall door alarm was a Radio Shack brand and different from the other door alarms. As opposed to a code on a keypad, the only way to deactivate the north door alarm was to use a key. Additionally, he explained that the alarm was battery operated and not hardwired into the Facility's other system. Periodically when maintenance performed its monthly alarm check, the batteries would have worn out and would need to be replaced. Tr. at 172-73. Petitioner's documentation indicates that the last maintenance check of the alarm prior to Resident 1's elopement was done on January 26, 2002, and contains a notation the alarm did not work. P. Ex. 7. There is no check mark on the form indicating that corrective action had been completed. Id. Because CMS did not question Petitioner's findings that all the door alarms had been checked after discovering Resident 1's elopement, and that all door alarms were operational, I see no need to focus on this possibility for purposes of this decision.

7. The DON told the surveyors that she expected the staff to do the 30 minute visual checks and document them as they did them and she expected the SCU staff to come out of the unit and check the resident when Resident 1 was off the unit. The staff of the SCU said they did not come away from the unit and check Resident 1 while she was off the unit. They thought the HC staff was responsible for checking on Resident 1. Tr. at 36. While the SCU staff believed the HC staff were responsible for doing the visual checks of Resident 1, the SCU staff documented the visual checks on the records when Resident 1 returned to the SCU. Tr. at 36; CMS Ex. 2, at 36, 39, 51.

8. I cannot conclude that Ms. Naysmith felt she was actually the person on staff who was to observe Resident 1 at 30 minute intervals. She had not previously charted that she had done such checks and she did not chart her observations at 6:15 p.m. and 6:45 p.m. She only included her observations in her write up of the events surrounding Resident 1's elopement. P. Ex. 34; Tr. at 260, 262, 264.