SUBJECT:

Riverwalk Village,

Petitioner,

Centers for Medicare & Medicaid

DECISION

Petitioner was not in substantial compliance with 42 C.F.R. § 483.25(h)(2) from May 31, 2001 through July 11, 2001, which resulted in actual harm to one resident but did not rise to the level of immediate jeopardy. The remedy proposed by the Centers for Medicare & Medicaid Services (CMS), a civil money penalty (CMP) of $4,200 ($100 per day for 42 days), is reasonable.

I. PROCEDURAL HISTORY

Petitioner participates in the federal Medicare program as a skilled nursing facility (SNF) and the State of Indiana Medicaid program as a nursing facility (NF). Petitioner is located in Noblesville, Indiana. The Indiana State Department of Health (the State agency) completed a complaint survey of Petitioner on June 18, 2001 and prepared a statement of deficiencies (SOD) bearing that same date. Petitioner was cited in the SOD for violation of 42 C.F.R. § 483.20(b) (F Tag 272) and 42 C.F.R. § 483.25(h)(2) (F Tag 324). F Tag 272 is not at issue in this appeal as it was deleted or resolved through the informal dispute resolution process. ⁽¹⁾ The violation of section 483.25(h)(2), one of the quality of care standards set forth in the regulations, is cited at a scope and severity level of G which translates as an isolated incident with actual harm to a resident but not amounting to immediate jeopardy. ⁽²⁾ CMS Ex. 5.

Petitioner was notified by letter from CMS dated August 22, 2001 that, based on the survey which ended on June 18, 2001, CMS was imposing a denial of payment for new Medicare and Medicaid admissions (DPNA) effective September 18, 2001, and a CMP of $100 per day effective May 31, 2001. It was determined from a revisit survey on July 19, 2001, that Petitioner achieved substantial compliance as of July 12, 2001. Thus, the DPNA never took effect. However, the CMP of $100 per day was imposed for the period from May 31, 2001 through July 11, 2001, 42 days, with a total CMP of $4,200. CMS Ex. 13 at 1-2.

Petitioner requested a hearing by letter dated October 15, 2001. The case was assigned to me for hearing and decision on October 26, 2001. A hearing was conducted in this case September 9 through September 11, 2002, in Indianapolis, Indiana. A 468-page transcript was prepared and reviewed by the Parties. During the hearing, CMS offered and I admitted CMS Exs. 1 through 11, 11A, 12 through 14, 14A, 15 through 67 and 67A. ⁽³⁾ Transcript page (Tr.) 13. Petitioner offered and I admitted into evidence Petitioner's exhibits 1 through 30. Tr. 16-17. Petitioner's exhibits 31 and 32, offered as demonstrative evidence, were not admitted initially for lack of foundation. Tr. 16-17. Subsequently, Petitioner's exhibits 31 and 32 were admitted for the limited purposes indicated on the record. Tr. 276-281; 338-340. CMS called two witnesses, State surveyors Lauretta Handy and Carol Novotny-Elmer. Petitioner called five of its employees as witnesses; Margaret Goodwin, Angela M. Dickson, Patty (Rios) Gordon, Bryndi (Eismen) Culbertson, and Jean Murdock. Petitioner indicated at the close of the hearing that motions to supplement the record would be filed post hearing. Tr. 456-463.

An undated motion was received from Petitioner on October 17, 2002, in which Petitioner moved for leave to supplement the record with P. Ex. 33 on grounds that it was a copy of the complete SOD (HCFA 2567L) in that it included Petitioner's plan of correction which needed to be reflected in the public record. The motion to admit P. Ex. 33 was not opposed. In a motion dated October 16, 2002, Petitioner moved for leave to "obtain and supplement the record . . . with the Surveyor Packet from the Indiana State Department of Health." I suspended the post hearing briefing schedule by order dated November 8, 2002, pending post hearing development of the record. On November 12, 2002, Respondent filed its response in opposition to Petitioner's motion. I concluded, based upon the Parties' pleadings, that the "surveyor packet" is relevant to my determination of the issues in this case. I also found that Respondent identified no specific prejudice related to production of the survey packet for the survey of Petitioner's facility which was completed on June 18, 2001. Therefore, on November 19, 2002, I ordered Respondent to obtain from the State agency and offer as the next CMS exhibit, the documents that comprise the "surveyor packet" related to the survey of Petitioner's facility completed on June 18, 2001. ⁽⁴⁾ Respondent submitted CMS Ex. 68 with its cover letter dated December 9, 2002. Respondent states in the cover letter:

Please note that CMS Exhibit 68 contains several documents that are not relevant to the issues in this case. The "surveyor packet", consisting solely of the documents created and collected during the June 18, 2001 complaint survey no longer exists in its original form. The Indiana State Department of Health's file regarding the June 18, 2001 complaint survey at Riverwalk Village contains, among other things, information collected at the time of the June 18, 2001 complaint survey, information gathered throughout the informal dispute resolution proceedings, and information gathered at revisit surveys. CMS Exhibit 68 is being submitted in the manner in which it was received from the Indiana State Department of Health.

On December 18, 2002, Petitioner objected to the admissibility of CMS Ex. 68 because it was not responsive to my Order of November 19, 2002, for most of the reasons listed by Respondent in the foregoing extract from its letter of December 9, 2002. Petitioner asked that I reject CMS Ex. 68 and order Respondent to permit Petitioner direct access to the State agency files. Respondent filed no response to Petitioner's objection.

In an order dated January 27, 2003, I sustained Petitioner's objection to CMS Ex. 68 and it was not admitted as evidence, but I directed that it remain with the record of proceedings in this case. I ordered that Respondent, on or before February 21, 2003, offer the surveyor packet related to this case or a reconstruction if necessary. ⁽⁵⁾ I also granted Petitioner's unopposed motion for admission into evidence of P. Ex. 33. On February 21, 2003, CMS submitted a reconstruction of the surveyor packet marked as CMS Ex. 68a. CMS Ex. 68a is admitted as evidence subject to the fact that it is a reconstruction and no state or federal official has certified it is complete. Petitioner's concerns regarding the completeness of the surveyor packet produced by CMS are discussed in Petitioner's post hearing reply brief at 7 and 8. Petitioner sought production of the complete surveyor packet to show that a Falls Circumstance Assessment (CMS Ex. 52; P. Ex. 15) had been released to the Surveyors, contrary to the implication of their testimony at hearing. The fact that CMS has not and, apparently, cannot certify that the surveyor packet is complete frustrates Petitioner's attempt to discredit the Surveyors on this point and to disprove the implication that the document may have been fabricated after the survey. To ensure no prejudice to Petitioner, I treat the Falls Circumstance Assessment (CMS Ex. 52; P. Ex. 15) as having been completed on May 27, 2001 consistent with the testimony of Petitioner's witnesses. Tr. 269-170; 309-311. ⁽⁶⁾

The Parties filed their post hearing briefs on January 10, 2003. Reply briefs were filed on March 3, 2003.

II. FINDINGS OF FACT AND CONCLUSIONS OF LAW

A. FINDINGS OF FACT

The following findings of fact are based upon the exhibits admitted and the transcript of the proceedings. Citations to transcript pages and exhibit numbers related to each finding of fact may be found in the analysis section of this decision.

1. Petitioner's facility, located in Noblesville, Indiana, participates in the federal Medicare program as a skilled nursing facility (SNF) and the State of Indiana Medicaid program as a nursing facility (NF).

2. The State agency completed a complaint survey of Petitioner on June 18, 2001 and prepared a SOD bearing that same date.

3. The State agency alleged that Petitioner violated 42 C.F.R. § 483.25(h)(2) (F Tag 324), related to quality of care, with respect to Resident 1 who suffered actual harm as a result.

4. CMS notified Petitioner of the alleged violation and that CMS intended to impose a CMP of $100 per day for the period from May 31, 2001 through July 11, 2001, 42 days, with a total CMP of $4,200.

5. Resident 1, was the resident involved.

6. Before May 27, 2001, Resident 1 had not fallen for more than a year.

7. On May 27, 2001 at about 11:30 p.m., Resident 1 got out of bed, climbing over or around her side rail; dislodging her Foley catheter; and tried to walk across the room, but fell causing a rug burn on her knee.

8. Petitioner reviewed the circumstances related to Resident 1's fall on May 27, 2001, concluded it was an isolated incident, and decided to implement no new interventions to prevent future falls.

9. On May 31, 2001, at approximately noon, certified nursing assistant (CNA) 1, Angela Dixon, took Resident 1 to the bathroom.

10. CNA Dixon left Resident 1 on the toilet with the call light in or near her hand and her wheelchair nearby.

11. CNA Dixon advised another CNA, Patty (Rios) Gordon, that Resident 1 was in the bathroom.

12. CNA Gordon checked on Resident 1 who was not yet done in the bathroom so CNA Gordon left her there but returned about 12:10 p.m. to 12:15 p.m. and found her sitting in her wheelchair.

13. At approximately 1:50 p.m. Resident 1's roommate used her call light to summon staff who found Resident 1 on the floor in her room.

14. Resident 1 admitted that she had been trying to walk and fell.

15. Resident 1 had a fractured left hip and subsequently died due to complications of hip surgery.

16. The Facility concluded after its investigation that Resident 1 transferred herself to her wheelchair after she finished using the toilet and that her saddle cushion was not engaged in her wheelchair.

17. On May 31, 2001, from 12:15 p.m. to 1:50 p.m., a period of 1 hour and 35 minutes, Petitioner's staff did not ensure that Resident 1 had her call light, did not provide any needed repositioning or use of the toilet, and did not ensure that the pommel cushion was in use, all of which were care planned interventions.

B. CONCLUSIONS OF LAW

1. Petitioner timely request a hearing.

2. The quality of care requirement is that, a facility such as Petitioner's, must ensure that "(e)ach resident receives adequate supervision and assistance devices to prevent accidents." 42 C.F.R. § 483.25(h)(2).

3. CMS made a prima facie showing by establishing that Resident 1 fell on May 27, 2001 and May 31, 2001 with minor injury on May 27, 2001 but a fractured hip on May 31, 2001.

4. The burden is upon Petitioner to show it acted reasonably to prevent Resident 1's falls, including whether it was reasonable not to implement certain specific interventions in light of the May 27, 2001 fall.

5. Petitioner took reasonable steps prior to the May 27, 2001 fall to protect Resident 1 against an accidental fall and injury and that fall does not represent a violation of 42 C.F.R. § 483.25(h)(2) .

6. After the fall of May 27, 2001, Petitioner was on notice that Resident 1 had fallen due to her attempt to walk after leaving her bed; that the interventions previously implemented were not effective to prevent the fall of May 27, 2001; that Resident 1 intentionally left her bed and attempted to walk; thus, it was not reasonable for Petitioner's staff to conclude that no new supervision or assistance devices were necessary to prevent or reduce the risk of accidental falls - a violation of 42 C.F.R. § 483.25(h)(2).

7. On May 31, 2001, Petitioner did not implement the interventions it had care planned for Resident 1, i.e., Petitioner did not give Resident 1 the supervision Petitioner had care planned for her, specifically ensuring that her call light was available; repositioning every two hours or as needed; assisting with using the toilet every two hours or as needed; and ensuring that the saddle or pommel cushion was being used for positioning in the wheelchair.

8. Petitioner's failure to implement its care planned interventions for Resident 1 is clearly a failure of supervision and a violation of 42 C.F.R. § 483.25(h)(2).

9. The CMP proposed by CMS is reasonable.

III. DISCUSSION

A. ISSUES

The issues in this case are:

1. Whether there is a basis for the imposition of an enforcement remedy because Petitioner was not in substantial compliance with the participation requirement stated at 42 C.F.R. § 483.25(h)(2) (F Tag 324 on the Statement of Deficiencies) from May 31, 2001 through July 11, 2001 as alleged by CMS; and

2. Whether the remedy proposed by CMS is reasonable.

B. APPLICABLE LAW

The Social Security Act (Act) sets forth requirements for long-term care facilities participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing long-term care facilities are found at 42 C.F.R. Part 483. Regulations governing survey, certification, and enforcement procedures, and regulations governing provider agreements, are found at Parts 488 and 489, respectively; and regulations governing appeals procedures are found at Part 498.

To participate in the Medicare and/or Medicaid programs as a SNF or NF, a long-term care facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies identified during a survey 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 "Quality of Care" requirement, each resident of a facility must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the resident's comprehensive assessment and plan of care. 42 C.F.R. § 483.25. Specifically, with regard to the subsection of the requirement regarding "accidents," a facility must ensure that: 1) the resident environment remains as free of accident hazards as possible; and 2) each resident receives adequate supervision and assistance devices to prevent accidents. 42 C.F.R. § 483.25(h).

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 DPNA, directed in-service training, and imposition of a CMP. See Act, section 1819(h). CMS may impose a CMP for each instance that a facility is not in substantial compliance with program requirements, regardless of whether or not the deficiencies constitute immediate jeopardy. 42 C.F.R. § 488.430(a). 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, a facility may not appeal the choice of remedies by CMS or the factors CMS considered when choosing a remedy. 42 C.F.R. § 488.408(g)(2).

CMS has the burden of coming forward with sufficient evidence to prove a prima facie case of noncompliance with a participation requirement where the facility contends that it in fact was complying with that requirement. In that circumstance, a long-term care facility has the ultimate burden of rebutting, by a preponderance of the evidence, the prima facie case of noncompliance introduced by CMS or any affirmative defense. 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 (D.N.J. May 13, 1999).

C. ANALYSIS

In order to evaluate a facility's compliance with the requirements of section 483.25(h), 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). Section 483.25(h) requires that a facility provide both "assistance devices" and "adequate supervision" to prevent accidents. What supervision or assistance devices are 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, DAB No. 1726 (2000), the Board considered whether the facility had notice 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, at 26-27. 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 more than minimal harm to a resident); or (2) it shows the facility failed to do what it could to supervise residents or provide assistive devices to minimize risks that could lead to accidents.

1. Petitioner was not in substantial compliance with the participation requirement stated at 42 C.F.R. § 483.25(h)(2) (F Tag 324 on the Statement of Deficiencies) from May 31, 2001 through July 11, 2001.

The facts important for resolution of this case are not disputed. On May 31, 2001, at approximately noon, certified nursing assistant (CNA) 1, Angela Dixon, took Resident 1 to the bathroom. CNA Dixon left Resident 1 on the toilet with the call light in or near her hand and her wheelchair nearby. CNA Dixon advised another CNA, Patty (Rios) Gordon, that Resident 1 was in the bathroom. CNA Gordon checked on Resident 1 who was not yet done in the bathroom so CNA Gordon left her there but returned about 12:10 p.m. to 12:15 p.m. and found her sitting in her wheelchair. ⁽⁷⁾ At approximately 1:50 p.m. Resident 1's roommate used her call light to summon staff who found Resident 1 on the floor in her room. Resident 1 admitted that she had been trying to walk and fell. Resident 1 complained of severe pain in her left hip. Her doctor was contacted who ordered that Resident 1 be transported to the emergency room where it was determined Resident 1 had a fractured left hip. Resident 1 subsequently died due to complications of hip surgery. The Facility concluded after its investigation that Resident 1 transferred herself to her wheelchair after she finished using the toilet and that her saddle cushion was not engaged in her wheelchair. She subsequently tried to walk and fell fracturing her hip. CMS Exs. 1 & 33; P. Exs. 17 & 18, at 16-18. These facts are sufficient to establish the CMS prima facie case - an accident involving a resident occurred with more than minimal harm to the resident.

A minimum data set (MDS) or basic assessment of Resident 1's ability completed for the seven-day period that ended on February 26, 2001, shows that during that period: Resident 1 could understand and be understood; Resident 1 needed extensive assistance with using the toilet including transfers and a one person physical assist; she did not walk in her room during the period; a wheelchair pushed by another was her primary means of locomotion; but for all seven days of the period she had transfer and walking restorative care or rehabilitation including walking 26 to 50 feet, walking for 11 to 15 minutes, with limited one person physical assist. P. Ex. 2; CMS Ex. 28. In March 2001, she was assessed as being at low risk for falls and not requiring any physical restraint but two bed side rails were ordered as enablers. P. Ex. 3. An assessment of Resident 1's abilities dated May 24, 2001, indicates some deterioration in her condition from February 2001. The notes from May 2001 indicate that Resident 1 needed assistance with all activities of daily living (ADL's); she was weak, tired easily, requested more naps, and required more assistance; she had difficulty maintaining a sitting position in her wheelchair and the use of a saddle cushion between her legs was implemented; she used the call light to summon staff for assistance; she was on a toilet schedule and use of the toilet required total assistance but her ability to transfer varied with how tired she was. P. Ex. 9. On May 24, 2001, Resident 1 was assessed as at moderate risk for falls, but no physical restraints are indicated on the physical restraint assessment form for that date. P. Exs. 10 & 12; CMS Exs. 55 & 59. On May 27, 2001 at about 11:30 p.m., Resident 1 got out of bed, climbing over or around her side rail; dislodging her Foley catheter; and tried to walk across the room, but fell causing a rug burn on her knee. P. Exs. 15 & 18, at 15; CMS Exs. 30, at 2 & 52. Resident 1's plan of care with an original date of July 26, 2000 and updated through June 2001 indicates that her primary means of locomotion was a wheelchair and she required total assistance. Interventions included assisting her with propulsion but encouraging her to propel herself and ensuring that her call light was available and answered promptly; and a hand-written entry reflects the addition of the saddle or pommel cushion to her wheelchair chair to help positioning. P. Ex. 20, at 1-3; CMS Ex. 38, at 5. Resident 1's plan of care also reflected her history of one prior fall and included, among other things, the following interventions: call light available and answered promptly; assisting with repositioning every two hours or as needed; and assisting with use of the toilet every two hours or as needed. P. Ex. 20, at 9; CMS Exs. 38, at 7, 61 at 1. Margaret L. Goodwin, a licensed practical nurse (LPN), a member of Petitioner's nursing staff, and a direct care giver for Resident 1, testified that after the fall on May 27, 2001, an interdisciplinary team reviewed Resident 1's situation and determined that the fall was an isolated incident and that no new interventions were required. Tr. 322-323.

Subsequent to the complaint survey of Petitioner's facility on June 18, 2001, the Surveyors recorded their findings in the statement of deficiencies (SOD). ⁽⁸⁾ As already indicated, the deficiency designated as F 272 (P. Ex. 33, at 2-6) related to resident assessment (42 C.F.R. § 483.20(b)) was deleted through the informal dispute resolution process and the allegations in that deficiency citation will not be considered further.

The Surveyors allege under F 324 that 42 C.F.R. § 483.25(h)(2) was violated with regard to Resident 1 because: (1) Resident 1 fell on May 27, 2001 and again on May 31, 2001 sustaining a left hip fracture; (2) Petitioner failed to assess Resident 1 in accordance with its falls prevention policy; (3) Petitioner failed to implement interventions of a "motion alarm" and designating Resident 1 as being part of Petitioner's "Falling Star Program;" (4) Resident 1's pommel cushion was not in place at the time of the May 27, 2001 fall; and (5) Resident 1's care plan had not been updated. P. Ex. 33, at 6-17.

The second, forth and fifth allegations against Petitioner are not supported by the evidence. The second allegation that Petitioner failed to assess Resident 1 is similar to the allegation cited under F Tag 272 that was deleted during the informal dispute resolution. Furthermore, the evidence of record clearly shows that Resident 1 was in fact assessed. The Surveyor's fourth allegation that Resident 1's pommel cushion was not in place at the time of the May 27, 2001 fall is not relevant. The pommel cushion was a device used in Resident 1's wheelchair chair and not her bed. On May 27, 2001, the undisputed facts are that Resident 1 got out of bed, not her wheelchair, and fell when attempting to walk. The fifth allegation that Resident 1's care plan was not updated is also not meritorious. Section 483.25(h)(2) obliges a SNF or NF to provide adequate supervision and assistance devices to prevent accidents. Care planning is required by 42 C.F.R. § 483.20(k) and failure to adequately care plan should be cited as a violation of that provision rather than section 483.25(h)(2). Furthermore, the Surveyor's allegations that Resident 1's care plan was not updated between the original date of July 26, 2000 and May 31, 2000 (P. Ex. 33, at 14) are factually inaccurate. The care plan page related to Resident 1's history of falls (P. Ex. 20, at 9) clearly shows it was reviewed and a handwritten date "3-7-01" was entered, new "Estimated Dates" of 01-01 and 04-01 were also entered. The implementation of the saddle or pommel cushion is also noted in the care plan. P. Ex. 20, at 1-2. Thus, it appears that the care plan was, in fact, up-dated.

The real focus of this case is upon the Surveyors' first and third allegations, i.e., that Resident 1 fell on May 27 and again on May 31, 2001, and that a motion alarm was not implemented for Resident 1 and she was not placed in the Petitioner's Falling Star program. It is undisputed that Resident 1 fell on both dates, no motion alarm was implemented, and Resident 1 was not included in Petitioner's Falling Star program. The issue that must be resolved is whether Petitioner acted reasonably to prevent Resident 1's falls, including whether it was reasonable not to implement certain specific interventions in light of the May 27, 2001 fall. ⁽⁹⁾ The quality of care requirement is that, a facility such as Petitioner's, 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 the facility is 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. ⁽¹⁰⁾ In the case of section 483.25(h)(2), the regulatory end is the prevention of accidental injury of nursing facility residents. Thus, it is incumbent upon Petitioner to show that all reasonable steps were taken to ensure Resident 1 had adequate supervision and assistance devices to prevent accidental falls.

Considering first the May 27, 2001 fall, I conclude that Petitioner had taken reasonable steps to protect Resident 1 against an accidental fall and injury. Resident 1 entered Petitioner's facility in 1998 and had no fall until May 27, 2001. Nevertheless, the Petitioner care planned certain interventions to minimize the risk of falls, including the use of a saddle cushion between Resident 1's legs to help her maintain positioning in her wheelchair; ensuring her call light was available and answered promptly; assisting with repositioning every two hours or as needed; and assisting with using the toilet every two hours or as needed. P. Ex. 20, at 9; CMS Exs. 38, at 7, 61, at 1. Petitioner also implemented the use of partial side-rails, albeit for the purpose of enabling self-repositioning rather than as a restraint. P. Ex. 3. These interventions were successful and reasonable and apparently prevented any falls until May 27, 2001. Petitioner had no information or reason to believe prior to May 27, 2001 that its planned interventions were not reasonable and effective. Accordingly, I conclude that Resident 1's fall of May 27, 2001 does not represent a violation of 42 C.F.R. § 483.25(h)(2).

Things changed on May 27, 2001 when, as Petitioner's own investigation showed, Resident 1 climbed over or around her bed side rails, got out of bed, tried to walk, fell, and was confused about what she had done. The new information Petitioner had as a result of this incident was that:

•Resident 1 had some confusion, perhaps different than staff had seen before;

•Despite her physical limitations and perhaps due to confusion Resident 1 was able to avoid or overcome the restraint or limit imposed by her bed side rail; and

•Resident 1 apparently thought she could walk and/or wanted to try indicating a lack of awareness of her physical limitations.

The evidence shows that after the fall on May 27, 2001, Petitioner's staff did consider or assess whether new or different interventions were required for Resident 1 but elected not to implement any changes based on the conclusion that the fall of May 27 represented an isolated incident. Tr. 311, 322. The issue is whether or not the decision not to implement new or changed interventions was reasonable in light of the facts known after the May 27, 2001 fall. I resolve this issue against Petitioner. Further, my review of the facts reveals that Petitioner not only failed to implement new interventions; Petitioner also failed to comply with its care planned supervision for Resident 1.

CMS alleges that Petitioner should have implemented a pressure sensitive alarm and designated Resident 1 as being subject to Petitioner's Falling Star program and that it was unreasonable for Petitioner not to have done so, particularly after the May 27, 2001 fall. My conclusion is that after the fall of May 27, 2001, Petitioner was on notice that Resident 1 had fallen due to her attempt to walk after leaving her bed. Once Petitioner's staff was aware that the interventions previously care planned were not effective to prevent the fall of May 27, 2001, especially because Resident 1 intentionally left her bed and attempted to walk, it was not reasonable for Petitioner's staff to conclude that no new interventions were necessary. ⁽¹¹⁾ Petitioner has not disputed that the interventions suggested by CMS were available for Resident 1 and there is evidence that had Resident 1 not died those interventions would have been implemented. CMS 38, at 7.

Even if I accepted Petitioner's argument that it was reasonable for Petitioner's staff to have determined that no new interventions were required for Resident 1 despite the fall on May 27, 2001, I would still find a violation on the facts of this case. It is clear from the evidence that on May 31, 2001, Petitioner did not implement the interventions it had care planned for Resident 1. Petitioner did not give Resident 1 the supervision Petitioner had care planned for her, specifically ensuring that her call light was available, repositioning every two hours or as needed; assisting with using the toilet every two hours or as needed; and ensuring that the saddle or pommel cushion was being used for positioning in the wheelchair. P. Ex. 20, at 9; CMS Exs. 38, at 7, 61, at 1. The facts in this regard are undisputed. At noon, on May 31, 2001, CNA Dixon, took Resident 1 to the bathroom and left her with call light in hand and her wheelchair nearby. CNA Gordon checked on Resident 1 shortly thereafter but left because Resident 1 was not finished in the toilet. Around 12:10 p.m. to 12:15 p.m. Gordon passed the room and saw Resident 1 sitting in her wheelchair. At approximately 1:50 p.m. Resident 1's roommate used her call light to summon staff who found Resident 1 on the floor in her room. There is no evidence of any staff contact with Resident 1 from 12:15 p.m. to 1:50 p.m., a period of 1 hour and 35 minutes during which Petitioner's staff did not ensure that Resident 1 had her call light, did not provide any needed repositioning or use of the toilet, and did not ensure that the pommel cushion was in use. Staff clearly made an erroneous assumption (Tr. 364, 374) rather than taking the simple step of entering Resident 1's room and checking her call light and pommel cushion. Petitioner's failure to implement its care planned interventions for Resident 1 is clearly a failure of supervision and a violation of 42 C.F.R. § 483.25(h)(2).

2. The remedy imposed by CMS is reasonable.

My conclusion that Petitioner violated 42 C.F.R. § 483.25(h)(2) and the undisputed fact that Resident 1's fall on May 31, 2001 resulted in a fractured hip, provide the basis for the imposition of a remedy. The issue remaining is whether the remedy proposed by CMS is reasonable. The only remedy is the $100 per day CMP beginning on May 31, 2001 and continuing through July 11, 2001 for a total of $4,200. Petitioner does not address the reasonableness of the CMP except to assert that there was no basis for a remedy. P. Brief at 30.

If a facility is found to be out of substantial compliance with participation requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. § 488.406, including a CMP (either per instance or per day). 42 C.F.R. § 488.408. I cannot review the choice of remedies by CMS (42 C.F.R. § 498.3(d)), but I must consider whether the amount of the CMP imposed against Petitioner is reasonable. Reasonableness of the amount of a CMP is determined by applying the factors listed in 42 C.F.R. §§ 488.438(f) and 488.404. Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1997). These factors include a facility's history of noncompliance; a facility's financial condition; a facility's degree of culpability, and the factors specified in section 488.404 which are considered in the selection of any remedy. The regulation calls for an initial assessment of the seriousness of the deficiency, which includes the degree or risk of harm that the deficiencies present and whether the deficiencies are isolated, part of a pattern, or widespread. 42 C.F.R. § 488.404(b). CMS may also consider "other factors, which may include, but are not limited to," how the deficiencies relate to each other and the prior history of compliance of the facility. 42 C.F.R. § 488.404(c). In this case, CMS has proposed a CMP of $4,200 ($100 per day for 42 days). A CMP ranging from $50 to $3,000 is authorized for a deficiency that does not amount to immediate jeopardy but either caused actual harm or had the potential for more than minimal harm. 42 C.F.R. § 488.438(a)(ii). The proposed CMP is thus at the lower end of the range. Considering all the relevant factors in light of the evidence, I conclude that the proposed CMP is reasonable.

IV. CONCLUSION

For the foregoing reasons I conclude as follows:

There is a basis for a remedy in that Petitioner violated 42 C.F.R. § 483.25(h)(2) by failing to appropriately supervise Resident 1 which resulted in actual harm to Resident 1.

A CMP of $100 per day for 42 days, May 31 2001 through July 11, 2001, a total of $4,200, is reasonable in this case.

KEITH W. SICKENDICK

Administrative Law Judge

1. CMS exhibit (CMS Ex.) 14A; Petitioner's exhibit (P. Ex.) 1.

2. CMS State Operations Manual (SOM), § 7400E.

3. The Parties agreed that CMS Ex. 18 is only probative as to the issue of the reasonableness of the remedies. Petitioner's hearsay objection was overruled but I have accorded such weight as I deem appropriate .

4. I also reestablished a briefing schedule .

5. Again, I express my concern that Respondent offered a collection of documents amounting to more than 600 pages, many of which Respondent admitted were not relevant. I remain troubled by the fact that Respondent offered no explanation for why the records of the State agency are in such disarray or worse, how some documents have been lost or destroyed. CMS and its agent, the State agency, know that appeals often occur when enforcement remedies are imposed. It is fundamental that when litigation is likely the parties must preserve the documents that support their claim or suffer the consequences. In this case, the Surveyors had some difficulty with their recollection of events related to the survey that occurred more than a year before the hearing, which impacts negatively upon their credibility. Further, the integrity of the State agency survey file for this case was legitimately questioned by Petitioner and, through post hearing development, it was demonstrated that the file lacked integrity in that the file was not carefully persevered. Because the surveyors' testimony and the survey files are usually critical to the CMS case, the loss of credibility of either the surveyors or their records would normally be fatal to the CMS prima facie case. CMS avoided such result in this case because few, if any, of the key facts are disputed and there has been no real question as to the integrity of Petitioner's records. Further, my review of the evidence is de novo and not dependent upon the conclusions of the Surveyors, the State agency, or CMS.

6. I note that the Surveyors did not testify that CMS Ex. 52/P. Ex. 15 did not exist at the time of the survey or allege that the document was a fabrication. Rather, they testified that the document was not given to them at the time of the survey. Tr. 76; 110; 114. The fact that the Surveyors might not have seen CMS Ex. 52/P. Ex. 15 is not disputed by Petitioner who offers the explanation that the document would have been filed in a quality assurance file rather than the Resident's chart. Petitioner's Reply Brief (P. Reply) at 8.

7. This rendition of the facts is consistent with CMS Ex. 33, the Fall Circumstance Assessment dated May 31, 2001 and the notification of an unusual occurrence dated June 1, 2001 (P. Ex. 17), both documents completed by Petitioner near the date of the event, but inconsistent with the testimony of Petitioner's witnesses, Angela Dixon and Patty (Rios) Gordon. CNA Dixon and Gordon testified that lunch was served around 11:00 a.m. (Tr. 358, 380) rather than noon as reflected in the two documents. I accept the contemporaneous records as the more credible versions of the events based upon the generally accepted proposition that memories fade with time.

8. Several copies of the SOD were admitted as evidence. However, there seems to be no dispute that P. Ex. 33 is a complete and accurate copy. Accordingly all references to the SOD are to P. Ex. 33 unless otherwise indicated.

9. The Surveyors indicate in the SOD that one or more members of the family requested implementation of these interventions following the May 27, 2001 fall. No member of the family was called to testify and I will not accept as probative this hearsay evidence which is not subject to being tested by cross-examination. Further, because there is no dispute that the interventions were not implemented, the hearsay evidence is not important to the CMS case for a deficiency cited under F Tag 324.

10. See Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203; 54 Fed. Reg. 5316 (February 2, 1989) ("The purpose of the revisions is to focus on actual facility performance in meeting residents' needs in a safe and healthful environment, rather than on the capacity of facility to provide appropriate services.").

11. Petitioner acknowledged in its post hearing brief at 5 that Resident 1 was at high risk for falls.