SUBJECT:

Golden Age Skilled Nursing & Rehabilitation Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Golden Age Skilled Nursing & Rehabilitation Center, was not in substantial compliance with Medicare and Medicaid participation requirements during the period August 12, 2002 to September 18, 2002. Petitioner failed to provide adequate supervision for one resident in violation of 42 C.F.R. � 483.25(h)(2). ⁽¹⁾ The Centers for Medicare & Medicaid Services' (CMS) determination that the violation presented immediate jeopardy is not clearly erroneous. A per instance civil money penalty (CMP) of $3,100.00 is reasonable.

I. PROCEDURAL HISTORY

Petitioner, located in Centerville, Iowa, is a long-term care facility certified to participate in the Medicare program as a skilled nursing facility (SNF) and in the Iowa Medicaid program as a nursing facility (NF). The Iowa Department of Inspections and Appeals (the State agency), completed a survey of Petitioner's facility on August 23, 2002, reporting its findings in a statement of deficiencies (SOD) with that date. Joint Stipulation of Fact dated February 14, 2003 (Jt. Stip. I).

CMS notified Petitioner, by letter dated September 9, 2002, that it was imposing a per instance CMP of $3,100.00 for the violation of 42 C.F.R. � 483.25(h)(2) (Tag F 324) as alleged in the SOD dated August 23, 2002. Joint Stipulation of Fact dated July 22, 2003 (Jt. Stip. II); CMS Exhibit (CMS Ex.) 1. A revisit survey was conducted by the State agency on October 16 and 17, 2002, and it was determined that Petitioner achieved substantial compliance with program requirements effective September 18, 2002. Jt. Stip. II.

Petitioner requested a hearing by an administrative law judge (ALJ) by letter dated November 5, 2002. The case was assigned to me for hearing and decision on December 2, 2002, and a Notice of Case Assignment and Prehearing Case Development Order (Prehearing Order) was issued at my direction on that date. The case was set for hearing for September 22 through 25, 2003. However, on July 22, 2003, Petitioner waived oral hearing, the parties having agreed that the case could be decided on the pleadings and documentary evidence. A briefing schedule was established by my Order of August 7, 2003. Petitioner and CMS timely filed opening briefs (P. Brief and CMS Brief, respectively) and they each filed reply briefs (P. Reply and CMS Reply). Petitioner offered Exhibits (P. Exs.) 1 - 23 and CMS offered Exhibits (CMS Exs.) 1 - 4. Petitioner's Ex. 23 is a video tape and Petitioner's Ex. 22 is a transcript of that tape. Paragraph B.4.b. of the Prehearing Order provides that video tapes will not be received as evidence. Petitioner has not shown good cause for deviating from that order. Comparison of the tape with the transcript does not show that the video tape has additional evidentiary value over that of the transcript and the video is merely cumulative. Accordingly, Petitioner's Exs. 1 - 22 are admitted. Petitioner's Ex. 23 is not admitted but will remain with the record for possible review by appellate authorities. Petitioner objected to the admission of pages 121 - 168 of CMS Ex. 4 arguing that the documents cannot be authenticated on the basis of the "Best Evidence Rule." I sustain Petitioner's objection on the grounds that CMS, as the proponent of CMS Ex. 4, pages 121 - 168, has failed to establish that those documents are authentic, i.e., that they are what they purport to be. See, e.g. Fed. R. Evid. 901. Petitioner submitted an affidavit of Gina Lee Banning, a registered nurse and employee of Petitioner who compared documents in Petitioner's files and the pages offered by CMS. Petitioner's Objection to Respondent's Proposed Exhibit, dated February 14, 2003. Nurse Banning identified numerous differences between the documents offered by CMS and facility records. In its response to Petitioner's objection, CMS reveals that the pages in question were printed by an unspecified individual from the State agency from an information system maintained by the Iowa Foundation for Medical Care. CMS alleges that the documents include information provided by Petitioner to the Foundation related to Resident 2. I have insufficient evidence to determine that the documents are what they purport to be, i.e., that they contain information reflecting Petitioner's assessment of Resident 2. The formal rules of evidence do not generally apply in administrative proceedings such as this. However, relevance and materiality are fundamental rules of evidence that are applicable. Relevance and materiality cannot be established by a proponent of evidence without first establishing the evidence is, in fact, authentic. The Federal Rules of Evidence describe the requirement for authentication as a condition precedent to admissibility. Fed. R. Evid. 901. The authenticity of CMS Ex. 4, pages 121 - 168, has not been established and those documents are not considered as probative evidence. However, pages 121 - 168 of CMS Ex. 4 will remain in the record for appellate review, if any. I also note, that even if authenticity could be established, Petitioner's assessment of Resident 2 is of no relevance to the disposition of this case. CMS Exs. 1 - 4 are admitted, except CMS Ex. 4 pages 121 - 168 are not admitted or considered as substantive evidence in this decision. Petitioner submitted P. Exs. 24, 25, and 26 with its initial brief and P. Exs. 27 - 30 with its reply brief. CMS made no objection to the admissibility of P. Exs. 24 - 30, and they are admitted.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

The following findings of fact are based upon the exhibits admitted. Citations to exhibit numbers related to each finding of fact may be found in the analysis section of this decision if not indicated here.

1. Petitioner, located in Centerville, Iowa, participates in both the Medicare and Medicaid programs.

2. On August 23, 2002, the State agency completed a survey of Petitioner and found Petitioner in violation of 42 C.F.R. � 483.25(h)(2) and other regulations.

3. On September 9, 2002, the State agency notified Petitioner that it intended to impose a per instance CMP of $3,100 based only upon Petitioner's violation of 42 C.F.R. � 483.25(h)(2), with respect to Resident 1.

4. After a revisit survey, CMS found Petitioner in substantial compliance with program requirements as of September 18, 2002.

5. Petitioner requested a hearing on November 5, 2002.

6. Resident 1 was admitted to Petitioner's facility on January 9, 2001.

7. Resident 1 suffered from an anxiety disorder, high blood pressure, diabetes, tremors, poor vision, and atrial fibrillation and she had to use a walker.

8. Resident 1's care plan, dated March 13, 2002, recognized a history of falls and specified that she wear non-skid, well-fitting footwear, that her environment be kept safe with clear pathways, and required that her walker be within reach at all times.

9. Resident 1 was coherent, alert, and oriented except for a few instances.

10. Resident 1 was required to wear a WanderGuard� bracelet, a transponder bracelet that triggered a door alarm when the resident approached a door with the alarm system.

11. Petitioner allowed Resident 1 to sit outside the facility, as she desired, at picnic tables at the front of the facility and Resident 1 had done so numerous times in the past with no apparent difficulty.

12. Staff knew when Resident 1 exited and entered the building because she triggered the door alarm, causing a staff member to check who triggered the alarm and to reset it.

13. Petitioner had no written plan for supervising or checking on Resident 1 while she was outside but Petitioner asserts that staff knew to check her intermittently.

14. On August 12, 2002, a staff member saw Resident 1 sitting outside the facility at the picnic tables with another resident who was also her roommate, but 10 to 15 minutes later the same staff member noted that Resident 1 was missing.

15. Resident 1 was found, unharmed, two blocks north of the facility on the sidewalk on the same side of the street as the facility.

16. Petitioner was not aware of Resident 1's departure or her location for a period of 10 to 15 minutes and had effectively lost all control and supervision over the resident until she was located and placed in a staff member's car.

17. Examples of foreseeable hazards for Resident 1 or a similar resident when outside Petitioner's building include the parking lot with approaching and backing cars and a potentially slippery surface given oil and water leaks; the low planter and low parking lot curb upon which a walker leg might catch; wet grass; uneven grass and dirt surfaces; the blunt ends of the horizontal surfaces of the picnic table and the table legs; and a street with traffic approximately 156 feet from the front of the building.

18. Petitioner has produced no evidence to show that a plan to supervise Resident 1, while she was outside, was actually formulated and implemented or that staff was aware of such a plan.

19. No staff members have been identified by Petitioner as having the responsibility for checking on Resident 1 the day of the incident and no staff has provided evidence that they did, in fact, check on Resident 1.

B. CONCLUSIONS OF LAW

1. Petitioner's request for hearing was timely filed and I have jurisdiction as to the alleged violation of 42 C.F.R. � 483.25(h)(2) but not as to any alleged deficiencies that are not the basis for imposing a remedy.

2. There is prima facie evidence that Petitioner violated 42 C.F.R. � 483.25(h)(2).

3. The narrow issue is whether or not Petitioner's supervision, as described by Petitioner in this case, was "adequate."

4. Petitioner did not provide adequate supervision to Resident 1 to prevent accidents, considering Resident 1's condition and the foreseeable hazards.

5. Resident 1 was unsupervised and left the facility grounds, exposing herself to the hazards of vehicle traffic, weather, uneven terrain, and similar hazards that present great risk of harm to one so impaired.

6. The declaration of immediate jeopardy was not clearly erroneous.

7. A per instance CMP of $3,100.00, is reasonable.

III. ANALYSIS

A. ISSUES

The issues in this case are:

Whether there is a basis for the imposition of an enforcement remedy; and, \

Whether the remedy imposed is reasonable.

B. APPLICABLE LAW

Petitioner is a long-term care facility participating in the federal Medicare program as a SNF and in the state Medicaid program as a NF. The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Social Security Act (the Act) and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest the Secretary of Health and Human Services (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. Facilities that participate in Medicare may be surveyed on behalf of CMS by state survey agencies in order to determine whether the facilities are complying with federal participation requirements. 42 C.F.R. �� 488.10 - 488.28.

Pursuant to 42 C.F.R. Part 488, CMS may impose a per instance or per day CMP against a long-term care facility when a state survey agency concludes that the facility is not complying substantially with federal participation requirements. 42 C.F.R. �� 488.406, 488.408, 488.430. The regulations at 42 C.F.R. Part 488 also give CMS a number of other remedies that can be imposed if a facility is not in compliance with Medicare requirements. Id.

The regulations authorize CMS to impose a CMP for an instance of noncompliance in the range of $1,000 to $10,000 per instance. 42 C.F.R. �� 488.408, 488.438. Pursuant to 42 C.F.R. � 488.301, "[i]mmediate jeopardy means 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." (emphasis in original). "Substantial compliance means 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." Id. (emphasis in original).

The Act and regulations make a hearing before an ALJ available to a long-term facility against which CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g), 498.3(b)(13). The hearing before an ALJ is a de novo proceeding. Anesthesiologists Affiliated, et al, DAB CR65 (1990), aff'd, 941 F.2d 678 (8^th Cir. 1991). A facility has a right to appeal a "certification of noncompliance leading to an enforcement remedy." 42 C.F.R. � 488.408(g)(1); see also 42 C.F.R. �� 488.330(e) and 498.3. However, the choice of remedies by CMS or the factors CMS considered when choosing remedies are not subject to review. 42 C.F.R. � 488.408(g)(2). A facility may only challenge the scope and severity level of noncompliance found by CMS if a successful challenge would affect the amount of the CMP that could be collected by CMS or impact upon the facility's nurse aide training program. 42 C.F.R. �� 498.3(b)(14) and (d)(10)(i). CMS's determination as to the level of noncompliance "must be upheld unless it is clearly erroneous." 42 C.F.R. � 498.60(c)(2). This includes CMS's finding of immediate jeopardy. Woodstock Care Center, DAB No. 1726, at 9, 38 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). The Departmental Appeals Board (the Board) has long held that the net effect of the regulations is that a provider has no right to challenge the scope and severity level assigned to a noncompliance finding, except in the situation where that finding was the basis for an immediate jeopardy determination. See, e.g., Ridge Terrace, DAB No. 1834 (2002); Koester Pavilion, DAB No. 1750 (2000). Review of a CMP by an ALJ is governed by 42 C.F.R. � 488.438(e).

When a penalty is proposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. "Prima facie" means that the evidence is "[s]ufficient to establish a fact or raise a presumption unless disproved or rebutted." Black's Law Dictionary 1228 (8^th ed. 2004); see also Hillman Rehabilitation Center, DAB No. 1611, at 8 (1997), aff'd Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999). To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); Batavia Nursing and Convalescent Inn, DAB No. 1911 (2004); Emerald Oaks, DAB No. 1800 (2001); Cross Creek Health Care Center, DAB No. 1665 (1998); Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Center v. U.S. Dept. of Health and Human Services, No. 98-3789 (GEB) (D.N.J. May 13, 1999).

C. DISCUSSION

In this case, CMS notified Petitioner that it was imposing a per instance CMP based upon a violation of 42 C.F.R. � 483.25(h)(2). CMS Ex. 1. Although other deficiencies were cited by the surveyors in the SOD dated August 23, 2002, CMS did not seek to impose any remedy based upon those deficiencies and they are not subject to appeal or my review. A facility may only appeal as to deficiencies that are alleged to be the basis for an enforcement remedy. 42 C.F.R. � 488.408(g)(1). CMS has also made clear in its briefs that it seeks to impose a CMP solely upon the alleged violation of 42 C.F.R. � 483.25(h)(2), as that violation relates to Resident 1. CMS Prehearing Brief at 1; CMS Brief at 6; CMS Reply at 3.

1. Petitioner violated 42 C.F.R. � 483.25(h)(2).

Section 483.25 of Title 42 C.F.R. establishes quality of care requirements for long-term care facilities. One such requirement is that a facility must ensure "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2). The regulation requires that a facility provide both "assistance devices" and "adequate supervision" to prevent accidents. In Woodstock Care Center, the Board considered whether the facility knew or reasonably should have anticipated the risk of the kind of events that occurred and whether any reasonable means were available to prevent them without violating the residents' rights. Woodstock Care Center, DAB No. 1726, at 26-27 (2000), aff'd, Woodstock Care Center v. Thompson, 363 F.3d 583 (6^th Cir. 2003). The Board in Woodstock noted that while a facility is permitted the flexibility to choose the methods it uses to prevent accidents, the chosen methods must constitute an "adequate" level of supervision and use of assistance devices given all the circumstances. What is "adequate" takes into consideration the resident's ability to protect himself or herself from harm. See Woodstock Care Center at 28-35; see also Windsor Health Care Center, DAB No. 1902, at 5 (2003), aff'd, Windsor Health Center v. Leavitt, 127 Fed. App. 843, 2005 WL 858069 (6th Cir. April 13, 2005) ("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.")

There is a prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2), when: (1) the evidence shows that an accident occurred, with or without harm to a resident; or (2) the evidence shows that the facility failed to do what it could to supervise residents or provide assistance devices to minimize risks that could lead to accidents. 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, App. P, Guidance to Surveyors, at PP-105, F324, Quality of Care (Rev. 274, June 1995); Woodstock Care Center, DAB No. 1726, at 4 (2000).

There is no dispute as to what happened with Resident 1 on August 12, 2002, the event that is the basis for the alleged deficiency. Resident 1 was admitted to Petitioner's facility on January 9, 2001. She suffered from an anxiety disorder, high blood pressure, diabetes, tremors, and atrial fibrillation. Resident 1 was independent and did not require supervision for most of her activities of daily living (ADLs), but required supervision with toileting and personal hygiene and limited assistance with dressing. Resident 1 suffered from an episode of hallucinations fourteen months prior to August 2002, attributed to an acute illness at that time. She also got dressed and tried to leave the facility about 2:30 a.m. on May 14, 2002. After the May 2002 attempt to leave, Resident 1 was required to wear a WanderGuard� bracelet, a transponder bracelet that triggered a door alarm when the resident approached a door with the alarm system. However, Petitioner did allow Resident 1 to sit outside the facility, as she desired, at picnic tables at the front of the facility. On August 12, 2002, Resident 1 was sitting outside the facility with another resident who was also her roommate. A staff member entering the facility saw the residents sitting outside. When leaving the facility a brief time later, the staff member noted that Resident 1 was gone. The staff member questioned Resident 1's roommate and then sought assistance to locate Resident 1. Resident 1 was found two blocks north of the facility on the sidewalk on the same side of the street as the facility. Resident 1 was returned to the facility in a staff member's car. Resident 1 was unharmed. Resident 1 told staff and the surveyor that she was glad staff came to get her because she was tired of walking and it was very hot outside. At the time it was about 83 degrees Fahrenheit with slight winds ranging from calm to 7 miles per hour. Jt. Stip. I at 2-4.

When she left the facility grounds on August 12, 2002, Resident 1 intended to walk to her sister's house. Resident 1 was using a walker. There is no dispute that a neighbor of the facility observed that Resident 1 attempted to cross the street but was apparently deterred by traffic and continued walking along the same side of the street as the facility, first on the grass then on the sidewalk. The staff member who observed Residents 1 and 2 sitting outside the facility on August 12, 2002, was the facility's activity director. The parties agree that no more than 10 to 15 minutes elapsed between the time that the activity director saw Resident 1 sitting outside and the time she noted Resident 1 was missing. The parties also agree that in March 2002, Resident 1 had an incident of approximately one hour when she was verbally abusive to staff and referred to herself by another name. The parties also agree that Petitioner had no established procedure for checking on Resident 1 when she sat outside except that staff did check "off and on." Jt. Stip. II at 3-4. Based upon the stipulated facts, there is prima facie evidence that Petitioner violated 42 C.F.R. � 483.25(h)(2). See Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002); Emerald Oaks, DAB No. 1800, at 16 (2001). Resident 1 was outside the facility and, at a time when she was not adequately supervised, she left the facility grounds attempting first to cross and then walking along a street that had some traffic. Petitioner was not aware of Resident 1's departure or her location for a period of 10 to 15 minutes and had effectively lost all control and supervision over the resident until she was located and placed in a staff member's car. Although Resident 1 was not injured, there can be no doubt that this was an unexpected, unintended event that could have resulted in the resident suffering bodily injury. Thus, the burden is upon Petitioner to rebut the prima facie case by showing that it was more likely than not in substantial compliance or by establishing an affirmative defense. Emerald Oaks, DAB No. 1800, at 16.

Petitioner's defense is that it was not foreseeable that Resident 1 was going to wander off as she did. Petitioner cites evidence that Resident 1 was coherent, alert, and oriented except for the few incidents already noted. Petitioner also points out that Resident 1 was permitted to sit outside and had returned to the facility without incident on multiple occasions. P. Brief at 6-7, 13-18. Petitioner also argues it provided supervision for Resident 1. Resident 1 wore a bracelet transponder that triggered the door alarm of a door equipped with an alarm system when Resident 1 approached too closely. According to Petitioner, it was the practice with Resident 1 that she would pass through the front door of the facility to go sit at the picnic tables at the front of the facility, which triggered the alarm. Staff would hear the alarm and check and see that Resident 1 triggered the alarm and that she was sitting at the picnic table out front. Staff would silence, but not deactivate the alarm system. When Resident 1 returned inside, she again triggered the alarm which alerted staff to the fact she was back inside the facility. Staff again silenced, but did not deactivate the alarm. When Resident 1 was sitting outside, staff would monitor her presence "off and on" or intermittently. Jt. Stip. II; P. Brief at 18-20. The gist of Petitioner's argument is that, given Resident 1's condition, the level of supervision Petitioner provided was adequate and it was not foreseeable that a greater level of supervision was required to prevent Resident 1 from leaving the facility grounds. Petitioner attacks the surveyor's credibility but, given the undisputed facts, this case does not turn on the credibility of the surveyor. Petitioner also argues that its response to Resident 1's elopement was adequate and proper. However, Petitioner's response to the elopement is not the issue or the basis for my finding of a violation of 42 C.F.R. � 483.25(h)(2). The narrow issue is whether or not Petitioner's supervision, as described by Petitioner in this case, was "adequate." I conclude it was not.

Review of Resident 1's condition, impairments, and limitations is appropriate when determining the adequate level of supervision required by the regulation. According to Petitioner's records, Resident 1 was 82 when she walked away from the facility on August 12, 2002. An annual Minimum Data Set (MDS), an assessment instrument completed by Petitioner with an assessment reference date of March 7, 2002, shows that Resident 1 had diagnoses of diabetes mellitus, a history of congestive heart failure, hypertension, a history of cerebrovascular accident or stroke, an anxiety disorder, macular degeneration with the ability to see large print but not regular print in newspapers or books, hearing impairment, osteoarthrosis, and atrial fibrillation. CMS Ex. 4, at 96, 98-100. Resident 1 had a short-term memory deficit and "modified independence" in decision-making. CMS Ex. 4, at 98. Resident 1's care plan dated March 13, 2002, recognized a history of falls and specified that she wear non-skid, well-fitting footwear, that her environment be kept safe with clear pathways, and required that her walker be within reach at all times. CMS Ex. 4 at 68. A RAP (resident assessment protocol) dated March 3, 2002, shows that Resident 1 was assessed as at high risk for injury due to the potential for falls. CMS Ex. 4, at 108. Petitioner produced an order from a Physician's Assistant dated August 23, 2002, after the survey, that states that Resident 1 may sit outside alone. P. Ex. 4, at 5; P. Ex. 29.

Petitioner calls attention to CMS Ex. 4, at 9, a photograph of the front of its facility and the picnic tables where Resident 1 usually sat. Petitioner argues that the picnic tables are close to the facility and about "half the distance of a football field" from the street (P. Reply at 4) or 156 feet according to Petitioner's Administrator (P. Ex. 27). Petitioner asserts that the close proximity of the picnic tables to the front of the facility and the distance to the street show that there was no foreseeable risk to Resident 1. P. Reply at 4. I note from my review of pictures admitted as CMS Ex. 4, pages 3 and 9, that the picnic tables appear to be placed upon a concrete, asphalt, or some other composite surface that appears to be firm and smooth. However, it is clear from the photograph at CMS Ex. 4, at 3, that the surfacing does not extend much, if at all, past either side of the picnic table benches or seating surface, and that to sit upon the seats of the picnic table it would be necessary for the resident to take some steps upon what is clearly a grass and soil surface. I also note that the photograph at CMS Ex. 4, at 3 shows that the approach to the picnic table is along the edge of the paved parking area with a narrow strip of grass that passes by a low planter made of block or stone. The parking lot appears to be edged by a raised curb or bumper that ends a few feet from the end of the picnic table in the photograph. CMS Ex. 4, at 3. The photographs at CMS Ex. 4, at 3 and 9 show that the grass and soil lawn is flat or slightly sloped toward the street. It is not possible to determine how smooth or even the surface of the grass and soil lawn is, but it is common knowledge that such a surface would not be as smooth as the flooring inside the facility or even the surface of the paved parking area.

Given the details I can glean from the photographs, Petitioner's assertion that there was "no foreseeable" risk to Resident 1 presented by her going to and sitting at the picnic tables is simply not credible. There is no dispute that Resident 1 had to use a walker and she had poor vision. Resident 1 did not ambulate as an unimpaired person would. Thus, what might not pose a risk of harm for an unimpaired person would be a foreseeable hazard to her. Examples of foreseeable hazards for Resident 1 or a similar resident include the parking lot with approaching and backing cars and a potentially slippery surface given oil and water leaks; the low planter and low parking lot curb upon which a walker leg might catch; wet grass; uneven grass and dirt surfaces; the blunt ends of the horizontal surfaces of the picnic table and the table legs; and of course the street itself, which Resident 1 demonstrated could be reached by a person so impaired in a very brief period.

Furthermore, Resident 1 had a care plan based upon her history of falls that specified that her environment was to be safe with clear pathways. Petitioner has presented no evidence that includes care planning for Resident 1's history of falls and making the outdoors safe for her either by assistance devices or adequate supervision. Although Petitioner asserts it had a plan that involved Resident 1 triggering door alarms so that staff knew when she entered or exited with intermittent checks by staff, Petitioner has produced no evidence to show that such a plan was actually formulated and implemented or that staff was aware of such a plan. ⁽²⁾ It is clear that some staff members were aware of the practice of Resident 1 but that does not constitute a plan of supervision. Further, Petitioner has produced no evidence that staff ever really checked on Resident 1 while she was sitting outside. It was fortuitous that Petitioner's activity director returned to the facility when she did, noted Resident 1 at the picnic table, and then on returning after 10 or 15 minutes, noted Resident 1 missing. No other staff members have been identified by Petitioner as having the responsibility for checking on Resident 1 the day of the incident and no other staff has provided evidence that they did, in fact, check on Resident 1. Petitioner focuses upon the notion it was not foreseeable that Resident 1 would wander off on August 12, 2002. However, Petitioner's focus is too narrow and Petitioner fails to recognize all the potential accident hazards Resident 1 or one similarly situated faced outside with no more supervision than Petitioner provided.

Based on the foregoing, I conclude that Petitioner did not provide adequate supervision to Resident 1 to prevent accidents, considering Resident 1's condition and the foreseeable hazards. Based upon all the evidence, I cannot find that the declaration of immediate jeopardy was clearly erroneous. Resident 1 was unsupervised and left the facility grounds, exposing herself to the hazards of vehicle traffic, weather, uneven terrain, and similar hazards that present great risk of harm to one so impaired.

2. A per instance CMP of $3,100.00, is reasonable.

I have concluded that Petitioner was not in substantial compliance with Medicare and Medicaid participation requirements during the period August 12, 2002 to September 18, 2002. Further, Petitioner's violation of 42 C.F.R. � 483.25(h)(2) posed immediate jeopardy for its residents.

Petitioner's argument that the amount of the per instance CMP proposed by CMS is unreasonable because CMS failed to consider or failed to adequately consider the regulatory factors, is unavailing. P. Brief at 29-20; P. Reply at 25. It is not for me to review how CMS exercises its discretion and determines the amount of a CMP to propose. My review of the reasonableness of a proposed CMP is de novo, i.e., I make an independent determination as to the reasonableness of a CMP based upon the evidence and regulatory factors. 42 C.F.R. � 488.438(e).

The applicable range for a per instance CMP is $1,000 to $10,000. 42 C.F.R. � 488.438(a)(2). The $3,100 per instance CMP proposed for the instance of noncompliance with 42 C.F.R. � 483.25(h)(2) is in the lower-third of the range of possible CMPs.

In determining a reasonable CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered: (1) the facility's history of noncompliance, including repeated deficiencies; (2) the facility's financial condition; (3) the seriousness of the deficiencies as set forth at 42 C.F.R. � 488.404; and (4) the facility's degree of culpability. In deciding what penalty amount is reasonable, I must examine the evidence that relates to the regulatory factors.

I have no evidence of a history of violations by Petitioner except the evidence related to the survey before me. The facility has not alleged an inability to pay, or submitted evidence of such inability. I consider the seriousness of the deficiency and potential for harm reflected by the foregoing discussion of the deficiency. I do find that Petitioner was culpable with regard to the violation of 42 C.F.R. � 483.25(h)(2). Petitioner offers no reasonable explanation for why it had no documented plan to adequately supervise and it has no evidence that it did adequately supervise Resident 1 while she was outside the facility building. I conclude that the amount of the CMP is reasonable.

IV. CONCLUSION

For the foregoing reasons, I conclude that Petitioner was not in substantial compliance with Medicare and Medicaid participation requirements during the period August 12, 2002 to September 18, 2002. A per instance CMP of $3,100.00 is reasonable.

Keith W. Sickendick

Administrative Law Judge

1. All references are to the revision of the Code of Federal Regulations (C.F.R.) in effect at the time of the surveys, unless otherwise indicated.

2. It is important to recall that because there is prima facie evidence of a violation, i.e., Resident 1 wandered off, the burden is upon Petitioner to show that it was providing adequate supervision. Petitioner never contends that there was actually a documented plan of supervision that recognized hazards and sought to minimize them consistent with the resident's right to go outside. Petitioner also never asserts that any staff actually checked on Resident 1 while she was out sitting at the picnic tables. Although Petitioner is not strictly liable for every accident and one-on-one supervision for every resident at Petitioner's facility was likely not reasonable, Petitioner has to show it did something to make Resident 1's environment safe for her, including the outdoors where Petitioner allowed her to be.