SUBJECT:

Country Club Retirement Center, Inc.,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Country Club Retirement Center, Inc., was not in substantial compliance with Medicare and Medicaid conditions of participation governing long-term care nursing home facilities from March 29, 2002 through April 3, 2002. The per day civil money penalty (CMP) of $350 per day for six days of noncompliance, for a total CMP amount of $2,100, is reasonable and approved.

I. Procedural History

Petitioner, located in Ashtabula, Ohio, is certified to participate in the Medicare program as a skilled nursing facility (SNF) and in the state Medicaid program as a nursing facility (NF). Petitioner requested a hearing by letter dated August 1, 2002, to challenge the findings of a standard survey of Petitioner's facility completed by the Ohio Department of Health (the state agency) on March 29, 2002. Based on recommendations of the state agency, the Centers for Medicare & Medicaid Services (CMS) initially proposed a $350 per day CMP, a denial of payment for new admissions, effective June 29, 2002, mandatory termination of Petitioner's provider agreement, effective September 29, 2002, and the loss of Petitioner's nurse aide training and/or competency evaluation program for two years due to the denial of payment for new admissions. By letter dated June 18, 2002, however, CMS rescinded the denial of payment and the termination remedies, and, due to the rescission of the denial of payment, Petitioner did not lose its nurse aide training and/or competency evaluation program. However, CMS did impose, as the only remedy, the $350 CMP for six days for the period March 29, 2002 through April 3, 2002. Petitioner was found in compliance as of April 4, 2002. CMS exhibit (Ex.) 3, at 1-3.

The case was assigned to me for hearing and decision on August 21, 2002, and, on that date, a Notice of Case Assignment and Prehearing Case Development Order was issued at my direction. I held a hearing in this case in Cleveland, Ohio, on January 27, 2003. CMS offered, and I admitted, CMS Exs. 1-6, with the caveat that I would not consider any irrelevant documents, which Counsel for CMS admitted were present in the CMS documents. Transcript (Tr.) at 16-18. Petitioner offered, and I admitted, Petitioner's (P.) Exs. 1-23. ⁽¹⁾ I also heard the testimony of CMS's witness, state agency surveyor Judith Louise Toth, R.N. (Tr. at 51-123), and Petitioner's witness, Marlene S. Blackford, R.N. (Tr. at 123-177). The parties filed post-hearing briefs (CMS Br. and P. Br.).

II. Findings of Fact and Conclusions of Law

A. Findings of Fact

The following findings of fact are based upon the testimony adduced at hearing and 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 is located in Ashtabula, Ohio, and is certified to participate in the Medicare program as a SNF and in the state Medicaid program as a NF.

2. Petitioner requested a hearing by letter dated August 1, 2002, to challenge the findings of a standard survey completed by the state agency on March 29, 2002, that it was out of compliance with participation requirements.

3. It was determined on a revisit survey on April 25, 2002, that Petitioner had achieved substantial compliance effective April 4, 2002. CMS Ex. 3, at 1.

4. Based on the March 29, 2002 survey, Petitioner was cited with being out of compliance with participation requirements found at: 42 C.F.R. �� 483.13(c)(1)(i); 483.15(a); 483.20(g); 483.20(k)(2); 483.25(g)(2); 483.25(h)(2); 483.25(m)(1); 483.35(h)(2); and 483.65(b)(3). CMS Ex. 1, at 1-21.

5. The only participation requirement still at issue in this case is the alleged violation of 42 C.F.R. � 483.25(h)(2), quality of care, found at Tag F 324 on the statement of deficiencies. Tr. at 15-16; CMS Ex. 1, at 9-16.

6. The deficiency found at Tag F 324 involved only one resident, Resident 35. Id.

7. . Resident 35, an 84-year-old male, was admitted to Petitioner's facility on July 23, 2001. CMS Ex. 2, at 5, 8. ⁽²⁾

8. Resident 35 had diagnoses including Lewy body disease, was severely cognitively impaired, did not have the ability to recall, and had no short or long-term memory. Tr. at 61; CMS Ex. 2, at 95.

9. Lewy body disease is a type of dementia which affects memory, language, the ability to judge distances, the ability to carry out simple actions, and the ability to reason. CMS Ex. 2, at 3.

10. One symptom of Lewy body disease is that an individual with the disease may experience falls for no apparent reason, because their ability to judge distances and make movements and actions accurately is disrupted. CMS Ex. 2, at 3.

11. Resident 35 needed assistance for transfers and ambulation. CMS Ex. 2, at 6.

12. Resident 35 scored a 12 on a fall risk assessment completed on July 23, 2001, and a score of 10 on an assessment completed on July 24, 2001. A score over 10 represents high risk . CMS Ex. 2, at 6; P. Ex. 4, at 4-5.

13. Resident 35's care plan dated July 23, 2001, assessed him as at risk for injuries from falls due to: an unsteady gait; extreme agitation; cognitive impairment; and ambulation by self. CMS Ex. 2, at 5.

14. Resident 35's care plan goal was that he would not sustain injuries from falls. CMS Ex. 2, at 5.

15. The interventions listed included on the care plan dated July 23, 2001, were: keeping Resident 35's environment clear of obstructions; monitoring the environment for wet spots or items below his field of vision; monitoring medications for side effects and possible cause of falls; ensuring a call light within reach and answered promptly; requesting OT (occupational therapy) and PT (physical therapy) evaluations; assisting with mobility as needed, and use of a self-releasing belt in the wheelchair. The care plan was updated July 30, 2001, November 20, 2001, and December 11, 2001 with the addition of interventions including use of a body alarm while in bed, use of a body alarm at all times, and a one or two person assist for ambulation and transfers. CMS Ex. 2, at 5.

16. Resident 35's physician ordered that he maintain a self-releasing seatbelt while he was in a wheelchair (CMS Ex. 2, at 256) and that he have a body alarm while in bed to achieve the goal of no injuries from falls. CMS Ex. 2, at 5; P. Ex. 4, at 2-3. Resident 35 had a history of throwing himself out of bed and of using a self-releasing restraint while sitting in a lounge chair. P. Ex. 3, at 2.

17. The fall/risk assessment dated July 24, 2001, stated that Resident 35 would be free of falls and not sustain serious injury from falls, noted that Resident 35 was at risk due to confusion, wandering, unawareness of safety needs, poor comprehension, gait and balance problems, and psychoactive drug use, and noted as interventions: call light within reach; supervision and verbal cues in hallways when ambulating; close supervision for self-ambulation; supervision and assistance with transfers/ambulation; encourage participation in social activities; provide adequate lighting and a night light; attempt orientation; reorient to call bell; bed alarm; water within reach; one siderail up; and teach to wear appropriate shoes. CMS Ex. 2, at 6.

18. Resident 35's plan of care did not indicate that he had a history of intentionally sitting down on the floor. CMS Ex. 2, at 5.

19. A social history completed on July 23, 2001, indicates that Resident 35 occasionally "slips to sitting on floor." P. Ex. 3, at 1. But, the citation does not indicate a history of a proclivity on Resident 35's part to intentionally sit down on the floor.

20. Petitioner required incident reports to be filled out for any incident in which a resident sustained an injury, including fractures, skin tears, bruising or cuts. Incidents involving falls with injuries necessitated complete vitals and follow-up interventions for three days, including neurologic checks for head injuries. All incidents were to be followed up with an investigation. CMS Ex. 2, at 22.

21. On 10 occasions from July 31, 2001 through March 15, 2002, Petitioner's records for Resident 35 show that he was found either on the floor or tipped over in his wheelchair.

22. On July 31, 2001, nurse's notes indicate that Resident 35 had fallen at 6:20 a.m. the day before, July 30, 2001. Resident 35 had gotten out of bed and was in the hallway outside his room. Upon questioning, Resident 35 stated that he had to go to the bathroom. CMS Ex. 2, at 8; P. Ex. 15, at 1.

23. Petitioner's investigation follow-up on July 30, 2001, revealed that Resident 35 was observed lying on the hall floor with a small amount of blood noted on his right arm and the back of his head. Resident 35 did not know what had happened, but remembered he was looking for the bathroom. CMS Ex. 2, at 258.

24. Following the July 30, 2001 fall, Petitioner noted on Resident 35's care plan that he was to ambulate with a one or two person assist, but no other interventions, such as increased supervision, were initiated at that time, despite the fact that Petitioner's investigation showed that Resident 35 was still confused, disoriented, and had behavior problems including being combative and agitated. CMS Ex. 2, at 5, 257, 258; P. Ex. 4, at 1. On August 1, 2001, Resident 35's physician recommended a restorative program of ambulation and range of motion with staff. P. Ex. 17.

25. At 5:30 a.m. on August 5, 2001, Resident 35 was found on the floor in another resident's room. There were skin tears on Resident 35's elbow, and traces of stool from his room to another resident's room, where a large stool was found. CMS Ex. 2, at 182. There was no investigation follow-up report available for review. Although this incident is not mentioned in nurse's notes for that period offered as evidence by Petitioner (P. Exs. 15 and 21) it is documented in nurse's notes obtained by the surveyor (CMS Ex. 2, at 244).

26. On August 6, 2001, a note to staff from the director of nursing (DON) stated that Resident 35 was to be checked every hour and instructed that, if he was restless, he was to be gotten up and toileted. The DON noted that he was getting up in the night to use the bathroom frequently. The DON stated this procedure was mandatory and not an option. P. Ex. 19.

27. Petitioner's Behavior Management Notes dated August 21, 2001, reflect Resident 35 eloped despite the fact that he was a wearing a Wander Guard personal alarm. The notes also reflect attempted elopements in August, September, and October 2001. The notes reflect Resident 35 was frequently agitated and aggressive with staff and other residents. P. Ex. 16. Nurse's notes show that Resident 35 eloped August 15, 2001, with multiple attempts thereafter. CMS Ex. 2, at 245-255. The August 15 elopement is also documented in an investigation follow-up. CMS Ex. 2, at 263.

28. On September 3, 2001, Resident 35 fell twice.

a. At 3:00 a.m., Resident 35 removed his personal alarm, hid it under his pillow, went across the hall and fell, receiving a small 1 cm. by 1.5 cm. abrasion on his right shoulder. CMS Ex. 2, at 8, 182, 248; P. Ex. 15. No new interventions were listed on his care plan (CMS Ex. 1, at 12), but the investigation follow-up recommended as a new intervention that staff check his alarm placement every hour. CMS Ex. 2, at 259. A note from the ADON dated September 3, 2001, states that Resident 35 was removing and hiding his body alarm and instructed staff that when he was in bed he was to be checked every hour to ensure his alarm was in place. P. Ex. 19, at 2; P. Ex. 20. Resident 35's physician was notified. CMS Ex. 2, at 247.

b. At 7:00 a.m., Resident 35 was walking and fell, bumping his head. Contemporaneous nurse's notes indicate that Resident 35 lost his balance and fell. CMS Ex. 2, at 248. However, a subsequent nurse's note dated September 4, 2001, suggests that he may have fallen due to shoe strings or a carpet/linoleum divide. CMS Ex. 2, at 8; P. Ex. 15. An intervention noted on what appears to be a care plan states that "Family brought new shoes for him." CMS Ex. 2, at 6.

29. On September 18, 2001, at approximately 8:30 p.m., nurse's notes indicate that Resident 35 was found tipped back in his wheelchair. There was a 2 cm. abrasion on the back of his head, and some bleeding was noted. Staff could not do a neurologic check because of Resident 35's agitation. There was no mention of the self-releasing seat belt. There was no investigation or follow-up for this incident. ⁽³⁾ CMS Ex. 1, at 12, 13; CMS Ex. 2, at 250.

30. On October 13, 2001, at approximately 10:00 p.m., nurse's notes indicating a late entry state that Resident 35 was found tipped back in his wheelchair, and that he had a small abrasion on the right side of the back of his head. Staff could not get vital signs due to his agitation. The nurse's notes did not state whether or not Resident 35 had his self-releasing belt, and no new interventions were added to his plan of care. CMS Ex. 2, at 252; CMS Ex. 1, at 13.

31. On October 28, 2001, at 12:00 a.m., nurse's notes indicate that Resident 35 was crawling up the hallway with a bleeding laceration to the crown of his head. Because Resident 35 was confused, Petitioner could not ascertain the cause of the injury and the resident was sent to the emergency room for evaluation. CMS Ex. 2, at 255. Although an investigation follow-up was completed (Id. at 260), no recommendations were made or noted on either the investigation follow-up sheet or in the care plan (Id. at 257).

32. On October 30, 2001, Petitioner requested that Resident 35's physician review Resident 35's medications due to Resident 35's aggression, weakness, and frequent falls. The physician did so, and adjusted Resident 35's medication. P. Ex. 23.

33. No falls are recorded for Resident 35 between October 28, 2001 and February 16, 2002.

34. On December 11, 2001, Resident 35's physician ordered a body alarm at all times to alert staff to Resident 35's attempts to make unassisted transfers. CMS Ex. 2, at 308; P. Ex. 23. This new intervention was noted on the plan of care. CMS Br. at 7.

35. February 16, 2002 nurse's notes, and an investigation follow-up on February 18, 2002, state that Resident 35 was observed sitting on the floor on his knees. He had removed his nightgown with his body alarm on it, got out of bed, and was in the hallway when a nurse came out of another room and saw him. He had sustained a 1 cm. laceration to the left side of his head and a 2 cm. abrasion to the right side of his head. Resident 35 denied falling and hitting his head, and staff could not tell if he had fallen or sat on the floor. CMS Ex. 2, at 310, 311, 261; P. Exs. 5, 6. No new interventions were recommended and it appears that no new interventions were added to his plan of care. CMS Ex. 2, at 257.

36. On February 19, 2002, Resident 35's physician ordered a change in his anti-psychotic medication. P. Ex. 7.

37. On February 21, 2002, nurse's notes indicate that Resident 35 was again found sitting on the floor in the hallway outside his room. He had previously been in bed. He was assessed for injuries and none were noted. CMS Ex. 2, at 313; P. Exs. 8, 9. The plan of care did not show any additional interventions were added. CMS Ex. 1, at 14. However, an affidavit from the DON, Karan Martin, indicates that there was intervention, in that the staff was re-educated on interventions to be used to prevent such incidents including checking him every hour. P. Ex. 9, at 2. Notes from a Fall Program Team Meeting indicated that on February 21, 2002, Resident 35 "sat himself on the floor . . . ." P. Ex. 10.

38. On March 15, 2002, an investigation follow-up indicates that Resident 35 removed his body alarm, scooted down in his bed, and slid onto the floor. Resident 35 sustained an abrasion on his right shoulder where he went down the side of the bed. Resident 35 was highly agitated and uncooperative. CMS Ex. 2, at 315; P. Ex. 12. No new interventions were recommended on the investigation follow-up. CMS Ex. 2, at 262.

39. As of March 15, 2002, Petitioner began checking Resident 35 at 30 minute intervals if he was awake, agitated, or showed any sign of wanting to get out of bed. He was to be cleaned, dressed, and gotten up. P. Ex. 13.

40. CMS determined to impose a per day CMP of $350 per day for six days.

41. There is no evidence of Petitioner's inability to pay the CMP imposed.

B. Conclusions of Law

1. Petitioner's request for hearing was timely and I have jurisdiction.

2. Resident 35 suffered 10 reported accidents that may be characterized as falls, including tipping over in his wheelchair, while a resident in Petitioner's facility.

3. Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F 324) by not providing assistance devices and adequately supervising Resident 35 to prevent falls in investigating, assessing, and intervening to prevent accidents from recurring.

4. Petitioner did not take all reasonable steps to make Resident 35 and his environment as accident free as possible, and Petitioner's investigations of Resident 35's falls, assessment of his needs, and interventions were not aggressive enough given Resident 35's known diagnoses of Lewy Body Disease and his history of accidents and falls.

5. Resident 35 suffered injuries, which are considered actual harm within the meaning of the regulations, as a result of accidental falls while in Petitioner's care.

6. CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2) (Tag F 324).

7. Petitioner has failed to rebut the CMS prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2) (Tag F 324) either by showing it was in substantial compliance or by an affirmative defense.

8. A per day CMP of $350 per day for six days of noncompliance, for a total CMP of $2,100, is reasonable.

III. Analysis

A. Issues

The general issues are:

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

2. 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 (Act) and at 42 C.F.R. Part 483. Sections 1819 and 1919 of the Act vest 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. 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, 488.300-488.335. 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 in 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 specify that a CMP that is imposed against a facility on a per day basis will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMP, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1)(i), (d)(2). The lower range of CMP, from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(1)(ii). There is only a single range of $1,000 to $10,000 for a per instance CMP, which applies whether or not immediate jeopardy is present. 42 C.F.R. �� 488.408(d)(1)(iv); 488.438(a)(2).

The Act and regulations make a hearing before an ALJ available to a long-term facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g); 498.3(b)(13). 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). 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. U.S. Dept. of Health and Human Services, 363 F.3d 583 (6^th Cir.2003). The Departmental Appeals Board (the Board or DAB) 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).

C. Discussion

1. Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F 324), which is a basis for the imposition of a CMP.

A facility must ensure that "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. � 483.25(h)(2). The specific manner by which facilities are to deliver care and services is not prescribed by the regulations. Rather, a facility is permitted to determine the means to achieve the regulatory ends. In the case of 42 C.F.R. � 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. The issue, generally, is whether the quality of the supervision or the use, or lack thereof, of assistance devices at a long-term care facility was such that residents were subject to the risk of injury from accidental causes in their daily activities. In order to evaluate a facility's compliance with 42 C.F.R. � 483.25(h)(2), it is necessary to examine whether the facility did all it could to "prevent foreseeable accidents" or whether the facility did "everything in its power to prevent accidents." Odd Fellow and Rebekah Health Care Facility, DAB No. 1839, at 6-7 (2002), quoting Asbury Care Center at Johnson City, DAB No. 1815, at 12 (2002), and Koester Pavilion, DAB No. 1750, at 25-26 (2000).

Pursuant to 42 C.F.R. � 483.25(h)(2), a facility must provide both "assistance devices" and "adequate supervision" to prevent accidents. Whether a facility's supervision or assistance devices can be considered adequate depends on what kind of measures would be calculated to prevent potential accidents from occurring given the known or reasonably foreseeable risks. In Woodstock Care Center, the Board considered whether the facility had notice of or should reasonably 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). Based on the regulation and the cases in this area, CMS meets its burden to show a prima facie case if: (1) it presents evidence that an accident occurred (with or without harm to a resident); or (2) it shows 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)." SOM, App. P, page PP-105, Guidance to Surveyors for Long Term Care Facilities, Part 2, F324, Quality of Care (Rev. 274, June 1995), Woodstock Care Center, DAB No. 1726, at 4 (2000).

I have set forth my findings of fact in detail above and do not restate them here. Given the facts I have found, I conclude that CMS has made a prima facie showing of a violation of 42 C.F.R. � 483.25(h)(2) by showing that Resident 35 was injured as the result of multiple accidents involving falls, i.e., CMS has produced sufficient evidence that, absent conflicting evidence, shows a violation occurred. Meadow Wood Nursing Home, DAB No. 1841, at 7 (2002); Emerald Oaks, DAB No. 1800, at 16 (2001). Petitioner violated 42 C.F.R. � 483.25(h)(2) (Tag F 324) by not adequately supervising Resident 35, in that Petitioner did not investigate, assess, or intervene adequately to prevent accidents from recurring, specifically in 10 instances where Resident 35 was found either on the floor or tipped over in his wheelchair. The burden is upon Petitioner to either, rebut the prima facie case by showing that it was more likely than not in substantial compliance; or establish an affirmative defense. Emerald Oaks, DAB No. 1800, at 16. Petitioner failed in its burden.

To rebut CMS's prima facie case, Petitioner argues generally that: (1) the citation to F Tag 324 is facially defective, as the allegations in the statement of deficiencies do not set forth the elements of the cited regulation and must be dismissed; (2) even if the citation was not defective, the evidence is insufficient that Petitioner violated the regulation; and, (3) even if the citation were valid, the CMP issued is disproportionate and should be eliminated or reduced. P. Br. at 1. It is significant that Petitioner does not dispute facts alleged by CMS regarding the circumstances of Resident 35's falls, the investigation of the falls, Petitioner's assessment of Resident 35's needs related to recurring falls, or the interventions Petitioner implemented or the timing of those interventions.

With regard to its first argument, Petitioner notes that each citation on the statement of deficiencies contains three distinct sections - a recitation of the regulatory section at issue, an allegation of the acts or omissions committed by the facility and then a recitation of the factual evidence. Petitioner argues that the regulation at issue requires that a facility must ensure that each resident receive adequate supervision and assistance devices to prevent accidents. Petitioner urges that the surveyor's allegations in the statement of deficiencies are defective because they allege that Petitioner failed to fully investigate and assess multiple falls to prevent accidents from recurring. Petitioner argues that the surveyors failed to allege a violation of 42 C.F.R. � 483.25(h)(2) (F Tag 324), as the citation does not allege either that Resident 35 did not receive adequate supervision or assistance devices to prevent accidents. Petitioner asserts that the surveyors allegations would be better cast under other regulatory provisions. Petitioner concludes that CMS has failed to identify the legal criteria to which it seeks to hold Petitioner, thus failing to make a prima facie showing of a violation. P. Br. at 2-3.

Petitioner misapprehends the nature of the statement of deficiencies. The statement of deficiencies is not an information or complaint, as in a criminal proceeding, and the surveyors who draft it are not attorneys. The statement of deficiencies is a notice document. In this case, the surveyors alleged a violation of 42 C.F.R. � 483.25(h)(2) and they alleged facts that they perceived to show a violation. Petitioner was clearly put on notice of the law CMS was relying upon and the facts CMS believed reflected a violation. Petitioner did not file a motion to dismiss prehearing for defective notice and did not move for a more definite statement from CMS. Most importantly, Petitioner appeared at hearing with documents and evidence fully prepared to defend against the specific charges made by CMS. Even if the statement of deficiencies was a poorly worded notice of the deficiencies alleged, there is no apparent prejudice and none is specifically alleged by Petitioner. Also, the language of the statement of deficiencies, cited by Petitioner at page three of its brief as the most offensive, indicates that Petitioner did not take actions "to fully investigate and assess the multiple falls . . . to prevent accidents from recurring." The language might have been more clear if had said "fully investigate, assess, and intervene" to prevent accidents from recurring, but intervention, in the form of adequate supervision and assistance devices, is clearly a concept inherent in the language chosen by the surveyors. Accordingly, I conclude that Petitioner's argument that the allegations of the statement of deficiencies were defective is without merit.

Petitioner argues next that the alleged deficiency should not be found because the surveyors' conclusions are in error. P. Br. at 3. Petitioner asserts that while the statement of deficiencies alleges that Petitioner failed to fully investigate and assess Resident 35's multiple falls, in fact, each incident was full investigated, properly assessed, and Resident 35 was provided with the appropriate care and supervision. ⁽⁴⁾

Petitioner never disputes that Resident 35 was at increased risk of falls due to his diagnosis of Lewy body disease. P. Br. at 4. Petitioner asserts that prior to admittance to the facility, Resident 35 also had a history of voluntarily sitting on the floor. Petitioner's witness, Ms. Blackford, testified that she noted that on admission Resident 35's family reported Resident 35 had various episodes where he would sit voluntarily on the floor. P. Br. at 4; Tr. at 158. Petitioner's suggestion is that not all 10 of the incidents reflected in its records for Resident 35 may have been falls, rather, he might have simply chosen to sit on the floor. I note that Resident 35's care plan did not indicate that he had a history of intentionally sitting down on the floor. See Finding 18. ⁽⁵⁾ Further, the social history completed on July 23, 2001, indicates that Resident 35 occasionally slips to sitting on the floor, specifically that Resident 35 had "3 falls in Feb 01 - stitches . . . on head, occasional slips to sitting on floor." P. Ex. 3, at 1. The citation does not indicate a history or proclivity on his part to intentionally sit down on the floor. Finding 19. The record shows that Resident 35 had a high risk of falling and injury from falls and he in fact fell and was injured on multiple occasions. Furthermore, Petitioner's records show that most of the incidents described in the statement of deficiencies where Resident 35 was found on the floor were unwitnessed. Thus, Petitioner's assertion that Resident 35 sat down rather than fell down is totally speculative and not based in fact. ⁽⁶⁾

Petitioner's care plan for Resident 35, did plan for falls. ⁽⁷⁾ Petitioner attempted interventions after some of the incidents and the CMS surveyor witness agreed that some of the interventions were appropriate. Petitioner points specifically to interventions including a restorative program initiated after the July 31, 2001 incident; the hourly checks of the resident after the August 5, 2001 incident; hourly checks for placement of the body alarm and ensuring new shoes were provided after the September 3 incidents; medication changes after the October 28 incident; medication changes after the February 16, 2002 incident; and increased monitoring of Resident 35 after the March 15, 2002 incident. P. Br. at 4-7. Petitioner also asserts that after the October 28, 2001 incident it assessed Resident 35 and altered his care plan to: place Resident 35 on the toilet in advance of need, to anticipate his toileting needs, and assist him as needed due to his unsteady gait; change his body alarm order to constant wear rather than only while in bed to alert staff of his attempts at self transfer and ambulation and assist him as needed due to his unsteady gait; monitor the body alarm every shift for effectiveness and good working order; continue to have Resident 35 followed by his psychiatrist to make medication changes; and monitor his behaviors by nursing and social services staff, including one on one, taking him for walks, and providing activities to help reduce agitation and provide for positive social interaction. P. Br. at 7. Petitioner did not provide citations to the record for all these interventions, but for purposes of my decision I accept that they did occur as alleged.

Petitioner concludes that Resident 35's diagnosis of Lewy body disease made him and his needs a "moving target." P. Br. at 8. Petitioner asserts that, like dealing with a reservoir that springs a leak unpredictably, the facility had to be continually reactive, heading off a recurrence of the last cause of a fall. Petitioner argues that despite the difficulty of this task, it was able to reduce the incidence of falls, while preventing all but the most nominal of injuries and preserving Resident 35's freedom from restraints as much as possible. Id.

Petitioner's duty, however, is to be more than just reactive. Petitioner's duty is to institute measures to prevent reasonably foreseeable accidents and not just react to the causes of prior accidents. Here, it was Petitioner's duty to be proactive in its supervision of Resident 35. Resident 35 had a disease that increased his risk for falls, he was a well known flight risk, he was combative with staff and aggressive with other residents, he required a two person assist for transfers, he ambulated all over the facility in his wheelchair, he had repeated falls. Petitioner cannot reasonably argue that it was not foreseeable that Resident 35 would fall. Petitioner's abbreviated investigations and failure to investigate in some instances resulted in no recommended interventions and there is, in most cases, no indication of interventions being implemented based upon investigation of cause and assessment of need. Thus, I can only conclude that Petitioner did not do everything in its power to prevent the foreseeable accidents in this case. Petitioner was clearly on notice, given Resident 35's diagnosis of Lewy body disease and his increased potential for falls and accidents, that his was a difficult case to manage. However, the continuation of accidents following the interventions attempted by Petitioner shows that the interventions attempted were not successful and not aggressive enough. For example, the bed alarm initiated by Petitioner was easily removed and Resident 35 got out of bed with ease. Although there was a period from October 28, 2001 to February 16, 2002, when Resident 35 had no documented accidents, it is not clear from the evidence that this was due to any of Petitioner's interventions. Minimally restrictive interventions were apparently never tried, for example, a low bed, a pressure sensitive alarm for Resident 35's wheelchair and bed rather than a tether that he was able to easily remove, visual checks and repositioning more frequently than every 30 minutes. While additional interventions might not have completely prevented the accidents, such interventions would have shown that Petitioner was aggressively monitoring Resident 35's situation, thus adequately supervising him and doing its best to stay in compliance with the regulations without imposing significant physical restraint.

2. A CMP of $350.00 per day for the period March 29, 2002 through April 3, 2002, for a total CMP of $2100.00, is reasonable based on the facts of this case.

In determining the amount of the CMP, the following factors specified at 42 C.F.R. � 488.438(f) must be considered: (1) the facility's history of non-compliance, 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. My role is not to review for correctness CMS's determination as to penalty amount. I must decide de novo whether the evidence justifies a particular amount.

Petitioner alleges the CMP imposed is unreasonable. It asserts that it had "perfect" annual surveys from 1997 to 2000, and only two deficiencies noted in its 2001 survey (neither of which was a repeat deficiency for the survey at issue here). Petitioner further asserts that the level of harm here is minimal given Resident 35's fragile physical condition, and that the conduct alleged was consistent with an individual who voluntarily sits on the floor. Petitioner notes that the deficiency related to a single resident showing improvement in having fewer reportable incidents and was, thus, not widespread. Finally, Petitioner notes that there was no neglect or indifference to Resident 35 on its part. P. Br. at 8-10.

Petitioner's assertion that the conduct in question was consistent with Resident 35 sitting on the floor is not supported by the evidence. Even if I accept Petitioner's other assertions, I conclude that the CMP imposed is reasonable. The applicable range of CMPs where no immediate jeopardy exists is $50 to $3,000 per day. $350 day is in the bottom fifth of the range. Further, CMS only proposed the CMP for six days, from the end of the survey on March 29 through April 3, 2002. Petitioner has conceded that it had a prior history of difficulty with its falls program, as cited in the October 2001 survey. P. Br. at 4. Petitioner has not alleged, and there is no evidence of, an inability on Petitioner's part to pay this modest CMP. Moreover, actual harm occurred to Resident 35; he sustained injuries due to the incidents in question. Findings 23, 25, 28, 29, 30, 31, 35, 38. I do find Petitioner's culpability to be slight, in that Petitioner did attempt intervention, albeit inadequate. Because Petitioner's culpability is slight, a CMP in the lower fifth of the range of possible CMP amounts is reasonable considering that Resident 35 sustained actual harm in this situation due, at least in part, to Petitioner's inadequate actions.

IV. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. � 483.25(h)(2) and that a CMP of $2,100 is reasonable.

Keith W. Sickendick

Administrative Law Judge

1. Petitioner's exhibits were initially marked as P. Exs. 7 through 29, but have been re-marked as P. Exs. 1-23. Tr. at 19-35.

2. CMS Ex. 2, at pages 5 and 257, are copies of the same document, a July 23, 2001 care plan for falls for Resident 35. There are other instances in the exhibits where more than one copy of the same document has been admitted. I may refer to only one copy of each document. In this instance, I will refer to CMS Ex. 2, at 5.

3. The nurse on duty failed to fill out an investigation report for this incident, and for the incident on October 13, 2001 (Finding 30). P. Br. at 6; CMS Br. at 5, n.4.

4. As a preliminary issue, Petitioner argues that I should not consider the seven incidents prior to October 30, 2001, based on the due process and double jeopardy clauses of the Constitution. Petitioner cites no authority for its assertion. Petitioner's theory seems to be that in an October 2001 survey Petitioner was cited for failure to properly administer its falls program, but not as a violation of Tag F 324, and this precludes any findings based upon any falls Resident 35 suffered prior to the October 2001 survey. I find no authority for the proposition that CMS is estopped from finding a provider deficient on a survey based on an act or omission not discovered or cited on an intervening survey. Furthermore, the 10 incidents cited by CMS are not separately charged as bases for remedies but, rather, are cited as examples in support of a general failure by Petitioner to comply with the regulation at issue and to show that Petitioner had knowledge of Resident 35's high risk for such accidents. Even if Petitioner's argument was considered to be meritorious, the incidents after October 2001 are sufficient alone to show a violation of the regulations.

5. The factual record and my findings of fact are set forth in detail in the Findings of Fact section of this decision. In the interest of judicial economy, I simply refer the reader to the appropriate finding of fact.

6. Of course, had Petitioner been adequately supervising Resident 35, Petitioner might have been able to prevent him from sitting down on the floor accidentally or voluntarily.

7. As noted in the findings, due to Resident 35's history of falling, Resident 35's physician prescribed both a personal body alarm and a self-releasing seatbelt while he was in his wheelchair. The surveyors have noted that after some of the falls Petitioner's staff did not state whether or not the self-releasing seatbelt was in place. See P. Ex. 1, at 11. I do not find such failure alone to be especially significant. What is significant, however, is that it is not clear from the facility's records how the resident fell, and it is this lack of clarity and investigation that is significant.