SUBJECT:

Lake Park Nursing and Rehabilitation Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Lake Park Nursing and Rehabilitation Center (Petitioner or facility), is a long term care facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS's) determination that, on January 26 and 27, 2003, it was not in substantial compliance with program participation requirements, and that its deficiencies posed immediate jeopardy to resident health and safety. The parties have agreed that this matter may be decided on the written record, without an in-person hearing. For the reasons set forth below, I find that the facility was not in substantial compliance with program participation requirements during the period in question, and that its deficiencies posed immediate jeopardy to resident health and safety. I therefore sustain the $3,050 per day civil money penalty (CMP).

I. Background

Following a complaint investigation/survey conducted on January 28, 2003, and completed February 7, 2003, surveyors from the North Carolina Department of Health and Human Services (State Agency) concluded that the facility was not in substantial compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. Specifically, it found that, for two days - January 26 and 27, 2003 - the facility did not meet federal requirements under 42 C.F.R. � 483.25 (Tag F-309 - Quality of Care) at a "J" level of scope and severity (immediate jeopardy to resident health and safety). CMS Exhibits (Exs.) 3, 5.

CMS agreed with the State Agency, and so advised the facility in a letter dated February 26, 2003. CMS Ex. 7. CMS imposed a CMP of $3,050 per day for the two days of alleged noncompliance, for a total $6,100 CMP. The letter also advised the facility that its nurse aide training program would not be approved. CMS Ex. 7.

Petitioner timely requested a hearing, and the case was assigned to me. CMS Ex. 7. After filing their initial briefs (Petitioner (P.) Pre-hearing Brief and CMS Pre-hearing Brief) and submissions, the parties have agreed that this case may be decided based on their written submissions, without an in-person hearing. See Order Granting Petitioner's Request for Waiver of In-Person Hearing (June 14, 2005); 42 C.F.R. � 498.66 (waiver of right to appear and present evidence). Pursuant to agreement of the parties, and my June 14, 2005 order, the parties filed additional briefs (P. Opening Brief and CMS Brief). Petitioner then filed a reply to CMS's brief (P. Response Brief), but CMS opted not to reply to Petitioner's brief. CMS has filed nineteen exhibits (CMS Exs. 1-19), plus the declaration of Surveyor Mary Ann Sawicki. Although my initial pre-hearing order instructed the parties to "exchange as a proposed exhibit the complete written direct testimony of any proposed witness," CMS did not mark Surveyor Sawicki's declaration. I have therefore marked the declaration as CMS Ex. 20. Petitioner has filed twenty-four exhibits (P. Exs. 1-24). In the absence of any objections, I admit CMS Exs. 1-20, and P. Exs. 1-24.

II. Issues

The case presents the following questions:

1. Whether, on January 26 and 27, 2003, the facility was in substantial compliance with program participation requirements for facilities participating in the Medicare and Medicaid programs, specifically 42 C.F.R. � 483.25.

2. If the facility was not in substantial compliance, did facility conditions pose immediate jeopardy to resident health and safety?

If I find substantial noncompliance at the immediate jeopardy level, the amount of the CMP will be sustained, inasmuch as the statutory minimum per day CMP in an immediate jeopardy situation is $3,050. ⁽¹⁾

Petitioner has raised some additional issues as to its due process rights and has complained about the conduct of the survey. However, I have no authority to consider such issues. See Order Summarizing Results of Prehearing Conference (June 2, 2005). ⁽²⁾

III. Statutory and Regulatory Background

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

To participate in the Medicare and Medicaid programs, facilities periodically undergo surveys to determine whether they comply with applicable statutory and regulatory requirements for Medicare (SNFs) and/or Medicaid (NFs). They must maintain substantial compliance with program requirements and, to be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

Under the statute and "quality of care" regulation, each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychological well-being, in accordance with the resident's comprehensive assessment and plan of care. Act, section 1819(b); 42 C.F.R. � 483.25. Accordingly, the facility must conduct an initial and periodic resident assessment of functional capacity that is comprehensive, accurate, standardized, and reproducible. 42 C.F.R. �� 483.20, 483.25. The facility must also make a comprehensive assessment of a resident's needs promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. � 483.20(b)(2)(ii).

The facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. � 483.25(h)(2). An "accident" is "an unexpected, unintended event that can cause a resident bodily injury," excluding "adverse outcomes associated as a direct consequence of treatment or care (e.g., drug side effects or reactions)." State Operations Manual (SOM) Appendix PP, Guidance to Surveyors, Part 2, SOP 483.25 Quality of Care (Rev. 274, June 1995) (SOM Guidance); see Woodstock Care Center, DAB No. 1726, at 4 (2000), aff'd Woodstock Care Center v. Thompson, No. 01-3889 (6^th Cir. Nov. 17, 2003) (unpublished).

Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment, or death to a resident." 42 C.F.R. � 488.301. CMS's determination as to the level of a facility's noncompliance - which includes its immediate jeopardy finding - must be upheld unless it is "clearly erroneous." 42 C.F.R. � 498.60(c).

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements or for each instance that a facility is not in substantial compliance. 42 C.F.R. � 488.430(a). In situations where the deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. Penalties in the range of $3,050 to $10,000 per day are imposed for deficiencies constituting immediate jeopardy. 42 C.F.R. � 488.438.

The parties' burdens in these proceedings are well-established. CMS must set forth a prima facie case that the facility was not in substantial compliance. Petitioner, in turn, has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004), aff'd Batavia Nursing and Convalescent Center v. Thompson, No. 04-3325 (6^th Cir. April 15, 2005); 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); See also, Community Skilled Nursing Centre, DAB No. 1987, at 4 (2005)

IV. Discussion

A. On January 26 and 27, 2003, the facility was not in substantial compliance with the program participation requirement set forth at 42 C.F.R. � 483.25. ⁽³⁾

The quality of care regulation, 42 C.F.R. � 483.25, imposes on facilities an affirmative duty designed to achieve favorable outcomes "to the highest practicable degree." Windsor Health Care Center, DAB No. 1902, at 16 - 17 (2003); Woodstock, DAB No. 1726, at 25 - 30. Among other specific requirements, the facility is required to "take reasonable steps to ensure that a resident receives supervision and assistance devices designed to meet his or her assessed needs and to mitigate foreseeable risks of harm from accidents." 42 C.F.R. � 483.25(h)(2); Windsor Health Care Center, DAB No. 1902, at 5 (2003); Asbury Center at Johnson City, DAB No. 1815, at 12 (2002); Koester Pavilion, DAB No. 1750, at 25 - 26 (2000); Woodstock, DAB No. 1726, at 25. The regulation requires the facility to anticipate what accidents might befall a resident and to take steps - increased supervision or the use of assistance devices - to prevent them. Guardian Health Care Center, DAB No. 1943, at 18 (2004).

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

Windsor Health Care Center, DAB No. 1902, at 5. Measures taken by the facility to prevent accidents must be considered in deciding whether the facility satisfies the regulatory requirement that each resident receive adequate supervision and assistance devices. Guardian Health Care Center, DAB No. 1943, at 12.

Here, Resident 3 (R3) was seventy-one years old and suffering from congestive heart failure, hypertension, osteoporosis, Parkinson's Disease, and chronic obstructive pulmonary disease when she was admitted to the facility on January 15, 2003. P. Ex. 6, at 2, 58-60; CMS Ex. 10, at 15, 20. She had a history of serious mental illness (paranoid schizophrenia with multiple personality disorder), long and short-term memory problems, and her cognitive skills were severely impaired. She had a significant history of wandering. On January 20, 2003, the facility assessed her risk for wandering, and determined that she was at high risk. A score of 12 or above on Petitioner's scale established high risk; R3 scored 20. P. Ex. 6, at 3-4, 9, 17, 30-34; CMS Ex. 10, at 5.

From the day of her admission, R3 exhibited wandering behavior and attempted to leave the facility. P. Ex. 6, at 45, et seq. A nursing note dated January 15, 2003, apparently written at midnight, describes R3 as

very agitated at the beginning of the shift. She was standing up [and] dragging along her oxygen tubing[,] almost tripping on it. She was attempting to leave the facility [and] stating that she was going home.

P. Ex. 6, at 45; CMS Ex. 10, at 29. The nurse responded by placing a Wanderguard on R3's left ankle. Id. Similarly, the following day, nurses notes describe R3 as "out in hall in [wheel chair] asking everyone she sees to take her home." Id. In an entry dated January 17, 2003, the nurse notes that R3 "needs close supervision [at] all times." (emphasis added) P. Ex. 6, at 46; CMS Ex. 10, at 31.

R3 was also unsteady on her feet, requiring limited assistance for ambulating. P. Ex. 6, at 3; CMS Ex. 10, at 26, 30. On January 19, 2003, she was "found" on the floor next to her wheel chair in her room. P. Ex. 6, at 49. A note dated January 20, 2003, indicates that she fell while attempting to walk. The facility responded by placing her in a merri-walker. ⁽⁴⁾ P. Ex. 6, at 10, 50, 70; CMS Ex. 10, at 33. She was on oxygen, and staff attached her oxygen tank to the back of the walker. She continued her wandering behavior, creating additional problems because she went into other resident's rooms, uninvited. Facility staff began to consider placing her in a secluded unit, or transferring her to another facility. P. Ex. 6, at 10, 45, et seq.; CMS Ex. 10, at 27, 34-37.

Petitioner says that on January 20, 2003, the facility developed a written care plan to address R3's risk. Several of its witnesses allude to that plan. Inasmuch as CMS does not challenge Petitioner's implication that it had the plan in place on January 20, 2003, I accept that Petitioner had an acceptable written care plan as of that date. However, Petitioner has not exactly produced an unambiguously contemporaneous written document containing the interventions it claims were implemented at that time. Rather than identifying exactly where in the record the written plan might be found, Petitioner cites generally to P. Ex. 6, pages 1-16. But pages 1-9 of P. Ex. 6 contain assessments, not plans. Page 10 appears to be nursing notes describing accidents that occurred on January 19 and 27, 2003. Pages 11 through 16 include care plans, but most of those plans were obviously developed after the January 27 incident. The plans found on pages 12 through 14 are dated January 28, 2003, with the description of the problem, the goal and the approaches separately dated January 28, 2003. This leaves just three pages of P. Ex. 6: pages 11, 15 and 16.

The documents on pages 15 and 16 are somewhat confusing. ⁽⁵⁾ Although they are dated January 28, 2003, they include problems, goals and approaches dated January 25, 2003. In any event, neither page specifically addresses the problems of R3's wandering or potential elopement. The document on page 15 instead addresses her problem of "maladaptive behaviors." In an entry dated January 25, 2003, the facility set a goal that R3 "would be free from injury to self or others." To accomplish this goal, staff were to explain procedures prior to their implementation, allow for a "calming period" before approaching her if she were agitated, redirect her to another activity when she was anxious, and encourage her participation in activities. She was to wear a Wanderguard bracelet continuously. P. Ex. 6, at 15.

The document on page 16 addresses her problem of "short and long term memory loss with impaired decision making and problem understanding others." The goal for this resident was to maintain her cognitive level of function through the next review. To accomplish this goal, staff was to evaluate the level of her cognitive loss, perform reality orientation and validation therapy and other approaches with the resident. P. Ex. 6, at 16.

Page 11 contains a typed care plan that reflects the interventions Petitioner alleges were in place to prevent R3's wandering. But every other care plan in the record includes the exact month/day/year of implementation and an estimated date for achieving the plan's goal. Each proposed intervention is then separately dated. P. Ex. 6, at 12-16. And the dates were obviously entered at the same time the document was generated; they are of the same font and an integral part of the text. In contrast, this document has handwritten in the margin "1-20-02." See also CMS Ex. 10, at 6 (for a more clear copy of the document). At the bottom someone has handwritten in "add to CP" (presumably, "Care Plan"). ⁽⁶⁾

The plan identifies R3's problem as "trauma, potential for R/T (related to) wandering." It sets as a goal: "Whereabouts will be known to staff at all times as demonstrated by no events of leaving facility." The following interventions were put into place to reduce R3's potential for injury: 1) frequent checks of the resident's location; 2) ensuring that the resident's identification bracelet was on at all times; 3) ensuring that alarmed exits were functional at all times; 4) orienting the resident to surroundings and room number as frequently as needed; 5) counsel wandering and praise appropriate behavior; 6) post the resident's name on her door; 7) ensure that the resident's picture and name were placed on the "wandering resident board;" and 8) involve the resident in activities as appropriate. P. Brief at 5; P. Ex. 20 (Holtzhausen declaration (decl.) � 7).

According to Frieda Holtzhausen, the facility's Director of Nursing (DON), R3's plan "was subsequently adjusted" to include use of the Wanderguard System and a merri- walker. ⁽⁷⁾ The facility also transferred R3 to a room closer to the nurses' station "to allow for closer observation." The facility also tried to get a psychiatric consultation. ⁽⁸⁾ Id. P. Ex. 20 (Holtzhausen decl. � 7).

The January 26, 2003 Incident

A nursing note written at 8 p.m. January 26, 2003, refers to R3's merri-walker having "been discovered" in the facility courtyard, and R3 sitting in the lobby, having suffered scrapes and abrasions to her elbow and knee:

[R3] observed sitting on table in lobby [with] BM on seat of pants and legs. Stated, "I just fell over in them trees." Per off going nurse. Merri-walker located outside in courtyard. Resident alert [with] confusion [at] times. Incontinence care and shower given. [Range of motion] to all extremities [within normal limits without complaints of] pain or discomfort. Scrapes/abrasions noted to [left] elbow [and] knee.

P. Ex. 6, at 54.; CMS Ex. 10, at 38.

Characterizing R3's injuries as "minor," Petitioner argues that "no competent evidence" establishes that R3 suffered an "'accident,' i.e. fell, on January 26, 2003," and that CMS presents no evidence of any facility noncompliance on January 26, 2003. According to Petitioner,

[T]hese [injuries] could have occurred while getting out of the Merry Walker or during her re-entry from the enclosed courtyard back into the lobby, given that she had a unsteady gait.

P. Opening Brief at 9. I agree that R3's injuries could have occurred almost anyplace in the facility or courtyard, and certainly could have occurred when she got out of her merri-walker. However, unexplained scrapes and abrasions to elbow and knee on one side of her body, together with the abandonment of her merri-walker, certainly suggest an accident, most likely a fall.

The uncontroverted evidence establishes that, notwithstanding its stated goal - R3's "whereabouts [would] be known to staff at all times" - and its plan for "frequent checks of the resident's location," sometime on January 26, 2003, R3 injured herself, soiled herself, and left her merri-walker (to which she and her compulsory supply of oxygen were purportedly attached) outside in the courtyard. And the facility offers no explanation as to what happened, nor exactly when it happened. That the facility made no apparent effort to figure this out hardly strengthens its case. It recognized that R3 needed "close supervision at all times," but provides no evidence as to where, how, or even when, within hours, R3's injuries occurred. Had R3 been appropriately supervised, injuries might still have occurred, but the facility would be able to explain something about the circumstances surrounding their occurrence. ⁽⁹⁾

The facility apparently had in place a "Documentation of Behavior" chart, which provides a space for filling in hourly observed target behaviors. Staff were directed to initial the entries at the end of each shift. P. Ex. 6, at 44; CMS Ex. 10, at 28; See also CMS Ex. 14, at 3-4 (policy regarding the Documentation of Behavior). For January 26, staff on the day shift (7 a.m. to 3 p.m.) reported her stripping her clothing off at 9 a.m., 10 a.m. and noon. From this, I could infer that someone was monitoring her behaviors during the day shift, but no entries at all were made by the 3 to 11 p.m. shift. Id.

At a minimum, based on R3's unexplained injuries and the abandonment of her merri-walker in the courtyard, CMS has established a prima facie case of noncompliance, and the facility has essentially offered no response. ⁽¹⁰⁾ I therefore conclude that on January 26, 2003, the facility was not in substantial compliance with 42 C.F.R. � 483.25(h)(2). ⁽¹¹⁾

The January 27, 2003 Incident

The following day, R3 is described as "wandering all around the building," going into other residents' rooms and taking their belongings. At about 7:35 or 7:40 p.m. that evening, an alarm went off. According to the nursing notes, written at 9:15 p.m., two nurses "checked system." Licensed Practical Nurse (LPN) Tamara Henry writes that, "assisted by housekeeping tech," she "searched the carport area and side of building," but did not see anyone, and returned to the facility. A visitor subsequently came in and reported seeing "some type of wheel chair down in the ditch while riding by." P. Ex. 6, at 54-56; CMS Ex. 10, at 38-40. ⁽¹²⁾ Two nurses went out, but were not able to see the resident from the building until they approached the ditch. They found her sitting in the ditch "between the rocks." She was muddy and bleeding. She had a lump on the back of her head, and abrasions on the top of her right shoulder, the back of her right arm, and right hip. Staff gave her a shower, and then put her to bed. They subsequently notified her physician, and sent her to the hospital. Id. LPN Henry noted that the "unobserved fall" occurred at 8:00 p.m., and she completed her assessment at 8:10 p.m. P. Ex. 6, at 65.

No credible evidence establishes that staff were adequately monitoring R3's whereabouts prior to her elopement. Petitioner offers no evidence from nursing staff in R3's unit, who were presumably responsible for the "frequent checks." Petitioner instead points to three pages of documentation to show that its staff made "routine, hourly location checks," citing P. Ex. 6, at 67-69. P. Opening Brief at 10. ⁽¹³⁾ Those pages consist of charts labeled "Resident Location Check." For each hour of the day, staff may fill in a code indicating where the resident is at the time: in bed (IB), out of bed (OB), or out of the facility (OOF). P. Ex. 6, at 68. But the documents only establish that the facility began this practice after R3 was found in the ditch outside the facility. P. Ex. 6, at 68. On P. Ex. 6, at 68, someone has handwritten across the top of the page "1/27/03 - 1/28/03." The first hour, 8:00 p.m., has a large X in the corresponding box. This was the hour staff found R3 outside the facility in the ditch. At 9:00 and 10:00 p.m. the chart indicates she was "in bed." From 11:00 p.m. through 3:00 a.m. January 28, "hospital" is written into the corresponding boxes. From 4:00 a.m. through 6:00 a.m., she is "in bed," and in the final hour of the chart, 7:00 a.m., she is "out of bed." In the "comments" box following the last hourly entry, someone has written "confused." P. Ex. 6, at 68. These entries are consistent with the nursing notes.

I find that the "Resident Location Check" sheet found at P. Ex. 6, at 67, covers the period from 8:00 a.m through 7:00 p.m. on January 28, 2003. After the last hourly entry, a comment is written and dated 1/28/03. P. Ex. 6, at 67. The last sheet, P. Ex. 6, at 69, begins at 8:00 p.m. January 28, 2003, and ends at 7:00 a.m. the following morning. The comment written in the "comments" box, is dated "1/29/03." P. Ex. 6, at 69. I note also that none of Petitioner's witnesses refer to these documents, much less claim that they were in place prior to R3's elopement. The record thus contains no evidence that these "routine, hourly location checks" began prior to R3's January 27 elopement.

I note also that on the "Documentation of Behavior" chart for January 27, 2003, staff indicate that in the early hours of the morning, 1:00 and 2:00 a.m., R3 was inappropriately wandering within the facility. At 8:00 a.m., she was again stripping off clothing and inappropriately wandering the facility. Again, however, no entries were made for the entire 3:00 p.m. to 11:00 p.m. shift that day. CMS Ex. 10, at 28.

The facility recognized that R3 would attempt to elope and that her elopement would jeopardize her health and safety. It determined that an adequate response to such risk included staff's frequently checking on her location. But Petitioner has offered no credible evidence that staff checked her whereabouts at all during the afternoon/evening of January 27, 2003.

With respect to the facility's subsequent actions, Petitioner argues that its responsibility for R3 ceased when she managed to exit the building undetected. Referring to the elopement, Petitioner writes,

What occurs after the event should have no bearing on whether the facility instituted appropriate measures designed to prevent accidents, particularly in a case such as this when the resident was only out of the facility for 5 - 10 minutes.

P. Opening Brief at 12. I reject this remarkable suggestion. The facility is required to protect its residents no matter where they might wander. Critical to preventing accidents is a facility's recognition that a wandering resident might elope, and that a frail and confused resident is at increased risk when outside the facility without supervision. It must therefore develop practices designed to return that resident quickly and safely to the facility.

I note also that the record simply does not support Petitioner's repeated claim that R3 was out of the facility for only five to ten minutes. Petitioner cites the absence of significant change in R3's oxygen saturation level as evidence that the entire elopement incident took only five to ten minutes. At most, that fact only suggests that she was separated from her oxygen, presumably because she had fallen into the ditch, for five to ten minutes. It says nothing about how long she was out of the facility. In fact, the uncontroverted evidence establishes that the exit alarm sounded at 7:35 - 7:40 p.m. LPN Henry, who was working that night, says that R3's accident occurred at 8:00 p.m. She was subsequently returned to the facility, and assessed at 8:10 p.m. P. Ex. 6, at 65. By any reasonable calculation, R3's time out of the facility far exceeded five to ten minutes.

The facility obviously recognized its obligation to residents who leave the building, because it had in place a Missing Resident policy, which Brenda Burton, Director of Regulatory Affairs and Policy Implementation of Britthaven, Inc., says "was designed specifically to promptly locate a resident known to be missing." P. Ex. 21, at 2 (Burton decl.� 14). The policy generally instructs staff to determine that a resident is actually missing, check the sign-out form, and search the building. If the resident is not in the facility, notify the Administrator, the DON, and supervisor. For an "out of facility search," search the grounds "as assigned by the licensed nurse;" then, if the resident is not found, notify law enforcement, the attending physician, responsible party, and continue the search "as indicated and as directed." P. Ex. 22; CMS Ex. 14, at 1.

The policy does not provide staff specific instructions for responding when an exit alarm sounds. According to Director Burton, "there is no certainty that any resident has exited the building at all" when the door alarm sounds, so, until the facility has identified a resident as "missing," the missing resident policy would not be implemented. "Once all residents were accounted for in that area, a facility-wide head count would occur." P. Ex. 21(Burton decl.� 14).

Although Petitioner offers no declarations from staff who were present at the time, and would have first-hand knowledge of these events, contemporaneous written statements from staff members working on the night of January 27, 2003, show their inadequate response to the sound of an exit alarm. When the alarm sounded, two nurse aides (Barbara Davis and Sherrie Osuagura) and a nurse (Katherine Bennett) were on duty in the secured unit, referred to as SPARKS. ⁽¹⁴⁾ LPN Katherine Bennett wrote that she "was redirecting" a resident away from an exit door on the SPARK unit when the alarm went off. She thought that the resident she was redirecting had set the alarm off attempting to open the door after her visiting family left. But a nurse aide told her that "it was the door outside of SPARK unit where the alarm went off and that door was not completely shut when she checked it. She stated that she looked outside and called out but did not see or hear anyone." CMS Ex. 13, at 1.

The nurse aide, Barbara C. Davis, wrote:

While in SPARKS around 7:35 pm I heard the alarms ringing, we didn't no (sic) where it was coming from, we checked all doors in our area. Nurse K. Bennett was at one exit and I check (sic) the others. When I realized it wasn't our doors, I went to check another door on another side nere (sic) the kitchen. The door was ringing and I opened the door and walked outside didn't see anyone I looked both ways while repeating the words hello! hello! (Sic) I closed the door made sure it was locked. Came back into SPARKS told Nurse Bennett that it was the door on the kitchen side.

CMS Ex. 13, at 2.

Sherrie Osuagura wrote that she was in SPARKS at 7:35 p.m.

We were putting pts. night clothes on. The [illegible] told us to have everyone in bed at 8 pm. We heard the alarm going off we check the doors in SPARKS (sic). Barbara went to the side door the door kitchen (sic) was open (sic) She went out the door and said anyone out here. (sic) No one responded so she came back in and the alarm went off. We started back putting residents night clothes on and passing snacks. She told the C nurse in SPARKS that the side door near to the kitchen was open.

CMS Ex. 13, at 3.

Four other staff members report simply that they were giving showers or getting residents ready for bed at that time. CMS Ex. 13, at 4, 5, 6, 8. Barry Polk, who appears to be the housekeeping tech referred to in LPN Henry's nursing note, writes "I was cleaning the maine (sic) dining room. Met the nurse looked but didn't see anyone in site (sic). CMS Ex. 13, at 7.

From these statements, I can reasonably infer that staff did not understand how to determine which door alarm was sounding. Indeed, "Nurse #1" (presumably LPN Bennett) admitted to the surveyor, in the presence of the facility administrator, that she did not know which alarms were for what doors. The administrator subsequently ordered that the nurses be trained on the door alarms, and sent the LPN home, noting that she would not be allowed to return. P. Ex. 1, at 8; CMS Ex. 3, at 8. By the time Nurse Aide Davis found the correct door, R3 was out of sight.

The statements also show that when they finally identified the correct exit door, staff took only a perfunctory look around the immediate vicinity, called out, and, when they heard no response, assumed it was a false alarm, closed and locked the door, and returned to their usual duties. Staff do not suggest that they intended to conduct a head count for the entire facility.

Director Burton justifies the staff's inadequate search by noting that no one even identified a resident as missing. P. Ex. 21 (Burton decl. � 14). That is obvious from the staff statements. But I do not accept Petitioner's claim that a passer-by so instantly appeared that a facility head-count was unnecessary. Not one staff person suggests that he/she even considered taking a facility-wide head count to determine if anyone was missing.

Further, I reject Petitioner's suggestion that it could not reasonably have anticipated that R3 would exit through a door so far from her room. As the facility recognized, R3 regularly wandered throughout the facility, and staff could reasonably have foreseen her exit through virtually any of the facility's exit doors.

Petitioner thus fell short of taking reasonable steps to mitigate foreseeable risks of harm. Staff recognized that R3 wandered, would attempt to elope, and that elopement would jeopardize her safety. Among other interventions, they determined that she required "frequent checks" of her location. But the evidence does not establish that staff consistently and frequently checked her whereabouts. The facility also had alarm systems in place, but staff plainly did not respond appropriately when an alarm sounded. The facility's actions (or inactions) placed R3 at risk and constitute substantial noncompliance with the quality of care regulation. 42 C.F.R. � 483.25(h)(2).

B. The facility conditions posed immediate jeopardy to resident health and safety.

I next consider whether CMS's immediate jeopardy finding was "clearly erroneous." 42 C.F.R. � 498.60(c)(2). The Board has observed repeatedly that the "clearly erroneous" standard imposes on facilities a "heavy burden" to show no immediate jeopardy, and has sustained determinations of immediate jeopardy where CMS presented evidence "from which '[o]ne could reasonably conclude' that immediate jeopardy exists." Barbourville Nursing Home, DAB No. 1962, at 11 (2005); Florence Park Care Center, DAB No. 1931, at 27-28 (2004), citing Koester Pavilion, DAB No. 1750 (2000).

Immediate jeopardy exists if the facility's noncompliance has caused or is likely to cause "serious injury, harm, impairment or death to a resident." 42 C.F.R. � 488.301. Here, R3 unquestionably suffered injuries as a result of the facility's noncompliance. The documentary evidence flatly contradicts DON Holtzhausen's declaration that R3 "had no injuries as a result of the incident." P. Ex. 20 (Holtzhausen decl. � 8). She had a lump on her head and multiple bruises and abrasions. Given her frail condition, her reliance on oxygen, and the proximity of the ditch, I do not find "clearly erroneous" CMS's conclusion that the facility's failure to protect her from accidents either caused or was likely to cause R3 serious harm. I therefore affirm CMS's immediate jeopardy determination.

C. Because I have determined the facility's noncompliance was at the immediate jeopardy level, the CMP must be at least $3,050 per day for each day of noncompliance.

Since I have determined that the facility was out of compliance at the immediate jeopardy level, the regulations limit my authority to review the amount of the CMP. In situations such as this, where the deficiencies constitute immediate jeopardy, CMS may impose a CMP in the range of $3,050 to $10,000 per day. 42 C.F.R. � 488.438. Where a CMP of $3,050 per day is imposed, the daily amount must be sustained unless the nursing home establishes that the determination of immediate jeopardy is clearly erroneous. Hermina Traeye Memorial Nursing Home, DAB No. 1810, at 16 (2002).

V. Conclusion

For all of the reasons discussed above, I uphold CMS's determination that on January 26 and 27, 2003, the facility was not in substantial compliance with program participation requirements, specifically 42 C.F.R.� 483.25 (Quality of Care), and that its deficiencies posed immediate jeopardy to resident health and safety. I therefore sustain the $3,050 per day CMP.

Carolyn Cozad Hughes

Administrative Law Judge

1. Of course, had I not found that the deficiency posed immediate jeopardy, I would have determined, as a matter of law, that a CMP of $3,050 per day is unreasonable, since $3,000 is the statutory maximum per day CMP for a non-immediate jeopardy situation.

2. My jurisdiction is limited to review of initial determinations, which are listed at 42 C.F.R. � 498.3. Moreover, I am bound by the statute and regulations, and have no authority to consider constitutional challenges to them. With respect to Petitioner's complaint that the surveyors failed to follow provisions of the State Operations Manual (SOM), I note that the SOM is not binding. It provides unpublished guidance to surveyors, but its provisions do not change the participation requirements set out in the regulations, by which I am bound. Alden-Princeton Rehabilitation & Health Care Center, DAB No. 1873, at 8 (2003); Beverly Health and Rehabilitation Center - Williamsburg, DAB No. 1748, at 8 (2000).

3. I make Findings of Fact and Conclusions of Law (Findings) to support my decision in this case. I set forth each Finding, in italics and bold, as a separate heading.

4. A merri-walker is an assistive device designed to enable individuals with impaired balance to ambulate. The device envelops the individual in a frame with a base wider than the area occupied by the individual's legs. A harness attaches the individual to the device. No one has suggested that a merri-walker is an adequate substitute for appropriate supervision. See, Madison Health Care, Inc., DAB CR1325, at 6, fn 2 (July 14, 2005) (manufacturer warns purchasers that residents should not be left on their own while using this product).

5. Petitioner apparently added some approaches on January 28 ^th to those already planned and dated January 25, 2003. P. Ex. 6, at 15 and 16.

6. A virtually identical document, but for the date, is found on the following page, P. Ex. 6, at 12, but that care plan unambiguously indicates on its face that it was generated on January 28, 2003.

7. In fact, documentary evidence shows that the Wanderguard was implemented on January 15, and the merri-walker put in place on January 20. P. Ex. 6, at 45, 50.

8. I do not doubt this statement, but find it a little puzzling inasmuch as R3 was taking powerful psychoactive medications and was presumably seen by her treating psychiatrist on a regular basis. P. Ex. 6, at 59.

9. In its reply brief, Petitioner makes much of CMS's unfortunate and inaccurate characterization of this event as an elopement. I agree that R3 did not elope at this time. However, the facility was also charged with protecting her from injury within the facility, which it failed to do.

10. That Petitioner bears this burden is particularly appropriate in a situation such as this. The surveyors may observe an injury or review documentation of an injury, but, assuming the facility is monitoring and investigating appropriately, it is in a far better position to explain what occurred.

11. Moreover, as discussed below, R3's subsequent elopement and the staff's inappropriate response show systemic problems in the facility's strategy for preventing accidents, which justifies a finding of substantial noncompliance prior to January 27, 2003.

12. Although Petitioner and CMS appear to have provided copies of the same nurses' notes which state "Family member came in facility. Made staff aware they seen (sic) some type of wheel chair down in the ditch while riding by." P. Ex. 10, at 49. In CMS's exhibit, however, someone has written in the margin "passer by." CMS Ex. 10, at 39.

13. Even if the documentation supported Petitioner's claim (which it does not), I am not convinced that an hourly location check is sufficient to protect an individual who needs "close supervision at all times."

14. Although R3 did not reside in the secured SPARKS unit, the record does not appear to contain the contemporaneous written statements from nursing staff working elsewhere in the facility that evening.