SUBJECT:

Highland Manor of Elko,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

Petitioner, Highland Manor of Elko, violated 42 C.F.R. �� 483.20(k)(3)(i) ⁽¹⁾ and 483.25, as alleged by the Centers for Medicare & Medicaid Services (CMS) based on a survey of the facility completed on November 15, 2002. There is a basis for the imposition of an enforcement remedy, and two per instance civil money penalties (CMPs), in the amount of $2000 for each violation, are reasonable.

I. Background

Petitioner, a skilled nursing facility (SNF) located in Elko, Nevada, was subject to a Medicare and Medicaid re-certification survey by the Nevada Department of Human Resources, Health Division (the state agency) that ended on November 15, 2002. The state agency determined that Petitioner was not in substantial compliance with participation requirements and recommended that CMS impose enforcement remedies. CMS notified Petitioner by letter dated January 31, 2003, that based upon the survey completed on November 15, 2002 and a revisit survey completed on January 9, 2003, Petitioner's Medicare and Medicaid provider agreement would be terminated on May 15, 2003, if substantial compliance was not achieved before that date. CMS's letter also advised Petitioner of the following: a denial of payment for new admissions (DPNA) would be effective February 15, 2003, based upon the findings of the survey completed on January 9, 2003; Petitioner's approval to conduct a Nurse Aide Training and Competency Evaluation Program (NATCEP) was withdrawn based upon imposition of a CMP of $5000 or greater and/or the DPNA; a per instance CMP of $2500 would be imposed for the noncompliance identified under Tag F 281; ⁽²⁾ and a per instance CMP of $2500 would be imposed for the noncompliance identified under Tag F 309, from the survey ended on November 15, 2002. CMS Exhibit (Ex.) 37. A revisit survey was conducted by the state agency on February 27, 2003, and Petitioner was again found not in substantial compliance with participation requirements. CMS Ex. 38. Petitioner was found to have achieved substantial compliance by a revisit survey completed by the state agency on April 15, 2003. Accordingly, Petitioner's provider agreement was not terminated, and the DPNA that began on February 15, 2003 was discontinued effective April 15, 2003. CMS Ex. 39.

Petitioner requested a hearing by an administrative law judge (ALJ) by letter dated March 28, 2003, challenging the findings and conclusions of the surveys completed on November 15, 2002, January 9, 2003, and February 27, 2003. The case was assigned to me for hearing and decision on May 2, 2003. On July 30, 2003, the parties executed a Joint Stipulation of Undisputed Facts (Court Ex. 1), in which Petitioner agreed that the only two alleged deficiencies remaining for adjudication are the alleged violations of 42 C.F.R. �� 483.20(k)(3)(i) (Tag F 281) and 483.25 (Tag F 309), from the survey ended on November 15, 2002. These two deficiencies were cited by CMS as the basis for the imposition of the two per instance CMPs of $2500; thus, those CMPs are in issue before me. CMS Ex. 37. Petitioner also stipulated that it conceded all facts in connection with the January 2003 survey and that it was not in substantial compliance as concluded by that survey. CMS cited the January 2003 survey findings as the basis for imposition of the DPNA; thus, the findings from that survey and the DPNA are not at issue before me. Furthermore, because imposition of a DPNA requires that the state withdraw authority to conduct a NATCEP, Petitioner's loss of its NATCEP authority is not in issue before me. See 42 C.F.R. �� 483.151(e); 483.151(b)(2)(v); section 1819(h)(2)(B) of the Act.

I conducted a hearing in this case on October 22 and 23, 2003, in Elko, Nevada. CMS offered as evidence, and I admitted, CMS Exhibits 1 through 6; 12 and 13; 17; 19 through 24; 26; 28 and 29; 32; 34 and 35; 37 through 44; 72 and 73; 75 through 77; 91; 94; 100 through 105. ⁽³⁾ Petitioner offered, and I admitted, Petitioner's Exhibits (P. Exs.) 1, and 3 through 11. I also marked the parties' signed Joint Stipulation of Undisputed Facts, dated July 30, 2003, as Court Ex. 1, and the parties' signed Pre-hearing Joint Stipulations, dated October 14, 2003, as Court Ex. 2. CMS presented testimony of the following witnesses: Judith Donaldson, Dora Goddard, Jennifer Dunaway, Barbara Cavanagh, Vicki Hutchings, Paula Perse, Christine Rushing, and Katherine Stewart. Petitioner presented testimony of the following witnesses: Audra Dana, Leanne Berry, Paula Harris, Fred Stapleton, and Joyce Stapleton. The parties filed posthearing briefs and posthearing reply briefs.

II. Discussion

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 Elko, Nevada, is a long-term care facility authorized to participate in the Medicare program as a SNF.

2. Petitioner was surveyed by the state agency and the report of the results of that survey are contained in a Statement of Deficiencies (SOD) dated November 15, 2002.

3. Petitioner requested a hearing by an ALJ by letter dated March 28, 2003.

4. In dispute before me are two deficiencies cited on the survey, alleged violations of 42 C.F.R. �� 483.20(k)(3)(i) (Tag F 281) and 483.25 (Tag F 309), and the per instance CMPs of $2500 for each alleged deficiency.

5. Resident 19's physician ordered that she be transferred only with a mechanical lift and her care plan included that requirement. CMS Ex. 19, at 12; CMS Ex. 72, at 1; Tr. 499.

6. On November 11, 2002, a fire alarm sounded in Petitioner's facility and Petitioner's staff transferred Resident 19 from her bed to a wheelchair using a three-person assist or lift rather than a mechanical lift. P. Ex. 1, at 19-24; Tr. 499.

7. It was quicker by as many as 15 minutes to transfer Resident 19 using a three-person assist rather than a mechanical lift. Tr. 499-503.

8. It was reasonable for staff to transfer Resident 19 using a three-person assist rather than a mechanical lift given the perceived emergency.

9. Resident 19 was evaluated by a speech therapist, placed on an appropriate diet, and special feeding procedures were implemented and made known to nursing staff.

10. Resident 10's care plan dated August 28, 2002, required staff to "use mechanical lift and 2 assist for all transfers." CMS Ex. 13, at 28.

11. During the survey, a surveyor saw two nurse aides transfer Resident 10 using a two-person pivot transfer without a mechanical lift. Tr. 404-08, 432-33.

12. Resident 10 experienced an increase in pain due to the use of a two-person pivot transfer. Tr. 413, 436-37.

13. On separate occasions prior to the survey, Residents 20, 21, 24, 29, and 9 were transported to medical appointments without anyone from Petitioner's staff accompanying or assisting them.

14. Residents 20, 21, 24, 29, and 9 were each assessed by Petitioner as being at risk and requiring monitoring, supervision, and assistance, and each of their care plans required specific interventions and services by Petitioner's staff. CMS Exs. 21, 23, 26, and 12; P. Exs. 6, 7, 8, and 3.

15. Residents 20, 21, 24, 29, and 9 had little or no ability to protect themselves from risks of harm.

16. Resident 20 suffered two broken femurs while in transit without supervision or assistance from Petitioner's staff.

17. Resident 26's Medicine Administration Record (MAR) documented a physician's order for 30 cc's of Milk of Magnesia when the resident had not had a bowel movement for three days and an order for a 10 mg Bisacodyl suppository when there was no bowel movement for four days. P. Ex. 9, at 18-19; CMS Ex. 24, at 16, 38.

18. Nurse's notes show that on November 12, 2002, Resident 26's daughter complained about the resident "grimacing and holding stomach" and that Resident 26 last had a bowel movement during the evening shift on November 7, 2002. P. Ex. 9, at 1, 3.

19. The nurse's notes show that staff administered a Dulcolax (Bisacodyl) suppository for Resident 26 on November 12, 2002, at 1:45 p.m., more than four days from her last documented bowel movement, and the resident then had a bowel movement during the evening shift on November 12, 2002. P. Ex. 9, at 1, 3-4.

20. There is no evidence that Milk of Magnesia was provided to Resident 26 as ordered after she passed three days without a bowel movement.

21. Resident 26 suffered pain or discomfort as a result of continuing constipation on November 13, 2002.

22. Resident 10 had physician's orders for staff to change her foley catheter monthly and provide catheter care on each shift, including daily irrigation with 30 cc's of normal saline, and checking for patency (making sure the catheter is not clogged); additionally, catheter care and keeping the catheter tubing off the floor to prevent infection were specifically required by her plan of care. CMS Ex. 13, at 16, 24, 117; P. Ex. 10, at 116; Tr. 459.

23. Petitioner did not perform catheter care on each shift for Resident 10 as required and failed to keep the catheter tubing off the floor to prevent infection.

24. Petitioner failed to monitor Resident 10's pain and reposition her every two hours as required by her care plan, causing increased pain for the resident. Tr. 438-39.

25. Resident 15's care plan required that she be monitored for increased signs and symptoms of pain, that effectiveness of pain medication be monitored, that the doctor be notified if pain was not controlled, and that the resident be repositioned every two to three hours or more frequently as needed. CMS Ex. 17, at 8-9.

26. Petitioner had assessed Resident 15 for pain, the resident had a pain care plan, her pain was monitored, and her doctor advised given the number of pain medication adjustments and changes made.

27. Resident 15 was medicated per orders and care plan during dressing changes on October 28 and November 4, 2002, but experienced breakthrough pain.

28. Petitioner did what it could to coordinate hospice services for Resident 15 and the evidence shows that some services, albeit limited, were provided as ordered by Resident 15's physician.

29. Petitioner has a history of violation of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) and 42 C.F.R. � 483.25 (Tag F 309) from a prior survey.

30. Petitioner was culpable for the violations of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) and 42 C.F.R. � 483.25 (Tag F 309) as determined on the survey in issue.

B. Conclusions of Law

1. Petitioner timely requested a hearing and I have jurisdiction.

2. Pursuant to 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281), the services provided or arranged by the facility, such as Petitioner's, must meet professional standards of quality.

3. Petitioner did not violate 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, by not using a mechanical lift for a transfer of Resident 19 during a perceived fire emergency.

4. Petitioner did not violate 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, as a preponderance of the evidence shows that a speech pathologist evaluation of Resident 19 was done as ordered and the recommendations resulting from that evaluation were documented and implemented.

5. Petitioner violated 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, by failure to use a mechanical lift for transfers of Resident 10 as required by her care plan.

6. Resident 10 experienced actual harm, increased pain, due to Petitioner's violation of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281).

7. Pursuant to 42 C.F.R. � 483.25 (Tag F 309), each resident of a long-term care 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.

8. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, because Petitioner failed to provide the necessary care and services to Residents 20, 21, 24, 29, and 9 by failure to provide adequate supervision to ensure their safe transportation to medical appointments outside the facility and by failure to ensure care planned interventions were performed while the residents were outside the facility.

9. Resident 20 suffered actual harm, two broken femurs, as a result of Petitioner's violation of 42 C.F.R. � 483.25 (Tag F 309).

10. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, because it failed to comply with Resident 26's care plan and physician's order and administer laxatives during the period November 7 through 12, 2002.

11. Resident 26 suffered actual harm, increased pain, as a result of Petitioner's violation of 42 C.F.R. � 483.25 (Tag F 309).

12. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, by failure to provide Resident 10 with foley catheter care as ordered and care planned.

13. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, by failure to comply with the requirements of Resident 10's pain care plan on November 13 and 14, 2002.

14. Resident 10 suffered actual harm, increased pain, as a result of Petitioner's violation of 42 C.F.R. � 483.25 (Tag F 309).

15. Petitioner did not violate 42 C.F.R. � 483.25 (Tag F 309) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, with regard to pain management for Resident 15, including assessment, monitoring, planning, and implementing the plan.

16. Petitioner did not violate 42 C.F.R. � 483.25 (Tag F 309) as alleged by the survey that concluded at Petitioner's facility on November 15, 2002, with regard to arranging for hospice services ordered for Resident 15, as available hospice services were arranged and provided.

17. Petitioner's violations of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) and 42 C.F.R. � 483.25 (Tag F 309) provide the basis for imposition of an enforcement remedy.

18. A per instance CMP of $2500 for Petitioner's violation of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) is not reasonable.

19. A per instance CMP of $2000 for Petitioner's violation of 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) is reasonable.

20. A per instance CMP of $2500 for Petitioner's violation of 42 C.F.R. � 483.25 (Tag F 309) is not reasonable.

21. A per instance CMP of $2000 for Petitioner's violation of 42 C.F.R. � 483.25 (Tag F 309) is reasonable.

C. 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.

D. Applicable Law

Petitioner is a long-term care facility participating in the federal Medicare program as a SNF. 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 of Health and Human Services (Secretary) with authority to impose CMPs against long-term care facilities 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. 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). Further, "[s]ubstantial 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 regulations specify that a CMP that is imposed against a facility on a per day basis will fall into one of two ranges of penalties. 42 C.F.R. �� 488.408, 488.438. The upper range of CMP, of from $3050 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 $3000 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 $1000 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 care facility against whom CMS has determined to impose a CMP. Act, section 1128A(c)(2); 42 C.F.R. �� 488.408(g); 498.3(b)(13). 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. U.S. Dept. of Health and Human Services, 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.

E. Analysis

1. Petitioner violated 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281).

42 C.F.R. � 483.20(k)(3)(i) provides:

The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity.

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(k) Comprehensive care plans.

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(3) The services provided or arranged by the facility must -

(i) Meet professional standards of quality . . . .

The SOM explains at Tag F 281 that "professional standards of quality" means that services are provided in accordance with accepted standards of clinical practice which may be determined based on a number of suggested sources. Surveyors are instructed by the SOM to question only those practices which have or potentially have negative outcomes and to ask the facility to produce the references that are the basis for the questioned practice. One specific question to be addressed by the surveyors is whether "physicians' orders are carried out, unless otherwise indicated by an advanced directive?" CMS Ex. 101, at 92-93.

With respect to the alleged deficiency cited under Tag F 281 in the November 15, 2002 Statement of Deficiencies (SOD), Petitioner argues in its posthearing brief that the SOD "simply states that the facility failed to ensure that 'the services provided or arranged by the facility met the professional standards of quality.'" Petitioner contends that this allegation is "overly broad and vague" and fails to adequately give notice to the facility as to what it allegedly did wrong. Petitioner's Posthearing Brief (P. Brief) at 2. I find no basis for Petitioner's vagueness argument. The sentence from the SOD quoted by Petitioner is only the general allegation of the regulatory provision violated; after this statement, the SOD then goes on to state the specific factual allegations pertaining to two specific residents. The general and specific allegations under Tag F 281 in the SOD (CMS Ex. 1, at 12-15) are clear and gave more than sufficient notice of the allegations for Petitioner to prepare and present a defense as amply demonstrated at hearing and by its briefing post hearing.

Under Tag F 281, CMS alleged that Petitioner failed to ensure that care and services met professional standards of quality for two residents who are identified in the SOD as Residents 19 and 10. CMS Ex. 1, at 12-15.

a. Petitioner did not violate 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) by not using a mechanical lift for a transfer of Resident 19 during a perceived fire emergency, and a preponderance of the evidence shows that a speech pathologist evaluation of Resident 19 was done as ordered and the recommendations resulting from that evaluation were documented and implemented.

Resident 19 was admitted to Petitioner's facility on October 30, 2002, with a history of aspiration pneumonia and left-sided paralysis from a previous stroke. P. Ex. 1, at 11, 36; CMS Ex. 1, at 13. The surveyors allege in the SOD that during a surveyor interview, Resident 19's daughter complained that on the evening of November 11, 2002, a smoke alarm went off due to smoke from repair work and Resident 19 was transferred into a wheelchair without the use of a Hoyer lift. Resident 19's daughter reported that Resident 19's left upper arm was broken from not using the lift. According to the SOD, the nurse's notes showed that Resident 19 was "transferred from the bed to the wheelchair with three man assist during fire evacuation procedures - care giver by side." CMS Ex. 1, at 14. The SOD states that the care giver reported to the staff that the resident complained of mild shoulder and chest pain. The nurse reported that no signs of an injury were found. The SOD states further that the nurse's notes on November 12, 2002, indicated that Resident 19 complained of left shoulder pain, but again, no signs of injury were found. Resident 19's daughter requested an x-ray, which revealed a left shoulder/humeral head fracture. CMS Ex. 1, at 14-15. It is also alleged in the SOD that Resident 19's physician had ordered that she be moved with a Hoyer lift, that the CNA (Certified Nurse Assistant) care plan required the use of the Hoyer lift, but the nursing care plan did not. CMS Ex. 1, at 15.

In response to these allegations in the SOD, Petitioner argues that Resident 19 was safely transferred on November 11, 2002. Petitioner contends that there was a fire in the facility on that day, and, given the emergency situation, facility staff acted appropriately in transferring Resident 19 with a three-person assist rather than using a Hoyer lift. ⁽⁴⁾ P. Brief at 9-10. Petitioner asserts that time was of the essence, and performing a three-person transfer takes about five minutes as opposed to approximately fifteen minutes for a Hoyer lift transfer. Petitioner argues that using a Hoyer lift is a "long and involved process" and it is, thus, unreasonable to expect facility staff to use it in emergency circumstances. P. Brief at 9-10. Finally, Petitioner contends that both the three-person transfer and Hoyer lift transfer are equally safe methods.

There is no question that Resident 19's physician ordered that she be transferred only with a Hoyer-type lift ⁽⁵⁾ and that her care plan included that requirement. CMS Ex. 19, at 12; CMS Ex. 72, at 1; Tr. 499. Based on the record, there were two different lifts at Petitioner's facility that could have been used to transfer Resident 19. The resident had her own lift that her family had brought from home for staff to use. CMS Ex. 19, at 4; CMS Ex. 1, at 14; Tr. 64, 81, 102-03. Petitioner's staff used her personal lift three or four times but stopped because it didn't fit under the bed. Rather than Petitioner's personal lift, staff used a facility-owned lift to transfer Resident 19. Tr. 64-65, 102-03.

There is no dispute that on November 11, 2002, the fire alarm sounded and Petitioner's staff transferred Resident 19 from her bed to a wheelchair using a three-person assist or lift rather than the Hoyer-type lift. In a three-person lift, three staff members use their bodies to physically lift a patient rather than using a mechanical lift. P. Ex. 1, at 21; Tr. 499. There is no question that staff transferred Resident 19 because a smoke alarm sounded in the facility, smoke was detected by staff, and it was deemed necessary to evacuate facility residents. P. Ex. 1, at 19-24.

I find that CMS has made a prima facie showing that Petitioner was in violation of 42 C.F.R. � 483.20(k)(3)(i) because there was a physician's order that specified Resident 19 was to be transferred only using a Hoyer lift (P. Ex. 1, at 58, 72, 117, 135), and staff admittedly transferred the resident without the lift on November 11, 2002 (P. Ex. 1, at 21-24, 44). However, in this case I find that the conduct of Petitioner's staff was reasonable under the circumstances. Paula Harris, a registered nurse and Petitioner's Director of Nursing, testified that it was quicker by as many as 15 minutes to evacuate the resident using a three-person assist rather than the Hoyer lift (Tr. 499-503), even though the lift that had been brought from the resident's home was apparently in her bathroom (CMS Ex. 19, at 48; Tr. 108). The weight of the evidence is that a transfer using a lift generally takes longer than a three-person assist. Tr. 134-35, 500, 502-03. CMS's witness, Dora Goddard, a CNA and Resident 19's private caregiver who witnessed the November 11, 2002 transfer, testified that it would take about 15 minutes to do a Hoyer transfer. Tr. 134. Ms. Goddard testified further that it probably took the three staff members less than five minutes to transfer Resident 19 once they all arrived. Tr. 128, 132. I note that CMS's witness, Surveyor Cavanagh, in response to my questioning, stated that she found no indication that the three-person assist was not done correctly. Tr. 235.

In judging the reasonableness of Petitioner's staff's conduct, it is reasonable to view the facts from the perspective of the staff at the time of the incident rather than based upon hindsight with the benefit of more facts than may have been known or apparent at the time - the approach CMS advocates. CMS Posthearing Brief (CMS Brief) at 7-9. Petitioner's staff was on the scene and in the best position to make judgments regarding Resident 19's transfer. The evidence that transfer with a mechanical lift could take 15 to 20 minutes is unrebutted by credible evidence. CMS suggests that rather than using a three-person assist, Petitioner's staff could have simply rolled the resident's bed out of the room or simply closed the door. CMS Brief at 8-9. It is not necessary for me to decide if either option would have been a better response to the fire alarm because the best response to a fire alarm is not in issue. The question is, when staff decided to transfer the resident, whether or not it was reasonable for Petitioner's staff to use a three-person lift rather than using the mechanical lift required by the care plan. I conclude, given the fire alarm and the unrebutted evidence of how much time could be saved by using a three-person assist rather than a mechanical lift, it was reasonable for staff to act as it did. Thus, Petitioner rebutted the prima facie case with regard to the incident involving Resident 19 on November 11, 2002. ⁽⁶⁾

The SOD in this case is not a model of clarity with regard to the other allegations regarding Tag F 281 and the examples cited relative to Resident 19 or how those examples amount to regulatory violations. According to the allegations of the surveyors in the SOD, Resident 19's admission orders included a pureed diet and a speech evaluation/swallowing study (CMS Ex. 1, at 13), and that is consistent with the evidence of record (CMS Ex. 19, at 11-12; P. Ex. 1, at 11). The SOD alleges that the surveyors reviewed "the record" for evidence that the speech therapist evaluation was done as ordered and they did not find documentation they sought. The SOD does not specify what record was reviewed; what documents were included in that record; or whether there was a requirement that such documents be in any particular file. The surveyors apparently did find one document that indicated the evaluation was done and they asked staff to provide a copy of the report. There is no question that a copy of the report was provided to the surveyors and it is in the record before me at CMS Ex. 19, at 6-9. There is no indication that the surveyors inquired about where staff found a copy of the report.

The speech therapist evaluation report provided to the surveyors showed that Resident 19 received a speech therapy evaluation on November 2, 2002, within a few days of the order that it be done. The report - specifically the forms titled "Speech Pathology Swallowing Recommendations" and "Bedside/Chairside Assessment of Swallowing Function" - recommended a modified barium swallow study to be completed as soon as possible; a mechanical soft diet; thickened liquids, 90 degree hip-flexion during and 30 minutes after meals; tuck chin while swallowing liquids and solids; liquids should be presented in a cup with a straw; and the resident should be encouraged to say "ah" with staff listening for any gurgling. CMS Ex. 19, at 6-9; P. Ex. 1, at 5, 7-8. The surveyors allege in the SOD that there was no evidence in Resident 19's record that Petitioner's nursing staff was aware of the speech therapist's recommendations for Resident 19's swallowing problem or had implemented these recommendations. CMS Ex. 1, at 14. Because it is not clear to which record the surveyors refer and the fact that the speech therapist evaluation was produced by staff from some record upon request by the surveyors, there is a significant question as to whether or not the allegation is well-founded.

In its posthearing brief, Petitioner argues that CMS appears to have abandoned the allegations concerning Resident 19's diet and feeding procedures. Petitioner contends that CMS put on no evidence at the hearing, apparently choosing to rely on the allegations in the SOD. Petitioner argues that such reliance on the SOD alone, without any supporting evidence, is insufficient to establish a prima facie case. P. Brief at 4. Petitioner is correct that CMS did not present any testimony at the hearing concerning Resident 19's swallowing problem. Further, CMS advanced no argument about this alleged deficiency in either its posthearing brief or posthearing reply brief. However, CMS did argue the example in its prehearing brief and, contrary to Petitioner's assertions, there is evidence in the record in CMS Ex. 19 and P. Ex. 1, and there is the testimony of Petitioner's dietician, Leanne Berry, in addition to the allegations of the SOD.

There is no dispute that Resident 19 had swallowing problems. There is no dispute that Resident 19 was evaluated by a speech pathologist on November 2, 2002, 13 days before the survey was completed. There is no dispute that the report of the speech therapist was produced to the surveyors upon request after the surveyors were unable to locate the report themselves. There is also no dispute that the speech therapist made the findings and recommendations reflected in the documents before me. The gist of the surveyors' allegations appear to be that the speech therapist's recommendations were not implemented.

In rebutting the allegations of the SOD, Petitioner contends that the record establishes that Resident 19 was evaluated by a speech therapist, placed on an appropriate diet, and special feeding procedures were implemented and made known to nursing staff. Petitioner argues that "there were comprehensive strategies for eating on the resident's care plan, which took into account and incorporated the speech therapist's recommendations." P. Brief at 8-9. Petitioner called Leanne Berry, a registered dietician and food service supervisor employed by Petitioner, to testify at hearing in support of its position that special feeding measures were in place for Resident 19. Ms. Berry testified that Resident 19 was fed most meals by her daughter or her private caregiver. Tr. 480. Ms. Berry testified that she worked with the speech therapist, that she was aware that a speech therapy evaluation was ordered for Resident 19 when she was admitted, and that she knew the evaluation and report had been done. Tr. 480-82. Ms. Berry testified that the speech therapist had set forth his recommendations in the document found at page 5 of P. Ex. 1, and that she would have received it from him. Ms. Berry testified that after getting the recommendations, she "wrote a special protocol and . . . made several copies" and "took it down to the dining room so that it could go with each plate or each tray when she was fed." Tr. 484-85, 487. She stated that she also instructed the CNAs. Tr. 485. Ms. Berry testified that dining room staff would be aware of the protocol because they would have received copies, and someone feeding Resident 19 would know the protocol because a note would be written on the bottom of her meal ticket and a copy would be on her meal tray each time she was served. Tr. 487-88. She testified that she gave a copy to Resident 19's caregiver and that the speech therapist did five or six training sessions. Tr. 486. Ms. Berry identified Resident 19's care plan with strategies for eating and swallowing that was initiated October 30, 2002 with updates November 19, 2002 and November 20, 2002 at Petitioner Ex. 1, at 137, and testified that that plan comported with the recommendations of the speech therapist. Tr. 492-93. Ms. Berry was not cross-examined by CMS and her testimony is unrebutted. Her testimony is consistent with her own notes at CMS Ex. 19, at 5. I have no reason to discount Ms. Berry's testimony. While I am not convinced that the care plan at P. Ex. 1, at 137 truly reflects the complete recommendations of the speech therapist, the weight of the evidence indicates that the speech therapist's recommendations were being followed to the extent that the resident's daughter permitted or cooperated; the deficiency alleged was not failure to update the care plan; and I have been cited no legal requirement that either all the speech therapist's recommendations be implemented or recorded in toto or in part in the care plan within the 13 days between the evaluation on November 2 and the end of the survey on November 15 or thereafter.

I conclude that the evidence does not support a conclusion that Petitioner violated 42 C.F.R. � 483.20(k)(3)(i) with regard to Resident 19 based on any failure to document or implement speech therapist recommendations.

b. Petitioner violated 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) by failing to use a mechanical lift for transfers of Resident 10 as required by her care plan and Resident 10 experienced actual harm in the form of increased pain.

For the example of Resident 10, the SOD states: "See F 309 related to provision of staff to ensure safe transportation of a resident." CMS Ex. 1, at 15. Tag F 309, which I discuss hereafter in the context of other alleged examples, alleges a violation of 42 C.F.R. � 483.25, the general quality of care regulation. Under Tag F 309, the surveyors allege, among other things, that Petitioner failed to provide safe transportation of residents. In its posthearing brief and posthearing reply brief, Petitioner argues that the SOD did not provide notice of how it violated 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) with respect to Resident 10. Petitioner contends that it is logical for it to assume that the transportation issue under Tag F 309 involves transportation on the Northeastern Area Transit (N.E.A.T.) bus (operated by Coach USA), not transfers of residents, and thus interpret the cross-reference as referring to NEAT bus transportation with respect to Resident 10. Petitioner contends further that there are no allegations under Tag F 309 that pertain to transportation involving Resident 10. Petitioner takes the position that it was "impossible for [it] to discern just what surveyors meant," and thus, there can be no finding of a deficiency under F 281. P. Brief at 11-12; P. Posthearing Reply (P. Reply) at 7-8.

Again the SOD is not a model of clarity. The description of the example of Resident 10 under Tag F 309 requires two pages of the SOD. CMS Ex. 1, at 27-29. Included in the allegations related to Resident 10 are that she had a care plan that required that all transfers be accomplished by a mechanical lift with a two-person assist. The surveyor alleged in the SOD that on November 14, 2002, the resident was transferred using a pivot transfer and not with a mechanical lift. CMS discussed the deficiency in its prehearing brief at pages 18-21, two months prior to the hearing. CMS references page 27 of CMS Ex. 1 (SOD) and, in a footnote, notes that "[t]he citation under F-281 is related to the second of two examples concerning Resident 10 in F-309." CMS Prehearing Brief at 18 n.11. CMS's prehearing brief asserts:

In this example, the professional standard that was violated is related to the failure to follow care planned interventions in that the facility failed to implement the care planned assistive device to ensure the safe transfer of a resident.

CMS Prehearing Brief at 19. CMS goes on to contend explicitly that Petitioner's staff "was not using a mechanical lift for all transfers with Resident 10." CMS Prehearing Brief at 19.

The question is whether within the four corners of the SOD (CMS Ex. 1) Petitioner should have been on notice that the transfer issue was the alleged basis for the Tag F 281 citation with respect to Resident 10, particularly in light of CMS's prehearing brief which clearly addressed the deficiency two months in advance of the hearing. I am not persuaded that Petitioner did not have adequate notice as to the factual underpinnings relating to Resident 10 and this deficiency citation.

Resident 10 was admitted on August 6, 2002, with diagnoses that included cerebellar vascular accident, dysphasia, and hypothyroidism. She was recovering from a recent hip fracture and two fractured shoulders. CMS Ex. 13, at 5. A review of Resident 10's record shows that her care plan dated August 28, 2002, required staff to "use mechanical lift and 2 assist for all transfers." CMS Ex. 13, at 28. The care plan noted that "[a]ll transfers are being done by lift at this time." CMS Ex. 13, at 28. A "Followup to Fall Risk Assessment," dated August 10, 2002, stated that Resident 10 "is transferred only using a Hoyer lift." CMS Ex. 13, at 49. Further references to Resident 10's transfer needs are contained in another assessment document, also dated August 10, 2002, which notes that Resident 10 "is transferred only using the Hoyer lift" and also that the resident "has needed total assist and the lift for all transfers." CMS Ex. 13, at 87, 100. Surveyor Katherine Stewart testified that she observed Resident 10 on November 13 and 14, 2002. She called for staff to care for the resident, and, when staff arrived, she went into the hallway. She testified that she saw two nurse aides transfer the resident using a two-person pivot transfer without a mechanical lift. She also testified that she concluded no Hoyer-type lift was used to transfer the resident from wheelchair to bed because staff never came to the hall to retrieve the lift. She confirmed this by asking a CNA who provided care and the CNA confirmed that Resident 10 was transferred using a two-person pivot transfer. Tr. 404-08, 432-33. Ms. Stewart testified that she did not believe Resident 10 suffered actual harm as a result of the transfer other than an observed exacerbation of her pain, but there was the potential for more than minimal harm. Tr. 413, 436-37.

Petitioner argues that it was not on notice for what to defend and does not present argument regarding the alleged facts. P. Brief at 11-12; P. Reply at 7-8. There is no dispute that Resident 10's care plan required the use of the Hoyer lift and a two-person assist for transfers. Surveyor Stewart provided convincing testimony that the resident was transferred without the use of a Hoyer-type lift as required by the care plan. Petitioner's staff's failure to follow the care plan and use a mechanical lift to transfer Resident 10, constitutes a prima facie showing that Petitioner was out of compliance with 42 C.F.R. � 483.20(k)(3)(i). Petitioner offered no evidence to rebut the CMS evidence nor did it establish an affirmative defense. ⁽⁷⁾

2. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309).

The regulation requires that:

Each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and plan of care.

42 C.F.R. � 483.25. The SOM instructs that deficiencies are to be cited under Tag F 309 only when a quality of care deficiency is not specifically covered by another quality of care tag. Surveyors are instructed to determine if the facility is providing necessary care and services based upon resident assessments and whether the facility is evaluating outcomes and changing interventions as necessary. The surveyor is to consider whether the facility is continually and aggressively implementing the plan of care and whether that plan is proper and updated. CMS Ex. 101, at 97.

CMS alleges under Tag F 309 that Petitioner violated the quality of care requirement in three areas:

� With respect to Residents 20, 21, 24, 29, and 9, CMS alleges that Petitioner failed to ensure their safety when they were transported to appointments outside the facility. CMS Ex. 1, at 16-25.

� With respect to Residents 26 and 10, CMS alleges that Petitioner failed to provide proper bowel and bladder care. CMS Ex. 1, at 16, 25-27.

� With respect to Residents 15 and 10, CMS alleges that Petitioner failed to adequately assess them for pain and develop a pain management program to meet their needs. CMS Ex. 1, at 16, 27-32.

a. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) with regard to Residents 20, 21, 24, 29, and 9 by failing to provide adequate supervision to ensure their safe transportation to medical appointments outside the facility and by failing to ensure care planned interventions were performed while the residents were outside the facility. Resident 20 suffered actual harm as a result.

It is not disputed that on separate occasions Residents 20, 21, 24, 29, and 9 were transported to medical appointments on the N.E.A.T. bus without anyone from Petitioner's staff accompanying or assisting them.

Resident 20 was assessed by Petitioner on her minimum data set (MDS) with a reference date of October 18, 2002, as being moderately impaired for decision-making, unable to walk, unable to maintain a sitting position without assistance, requiring extensive assistance for transfers, unable to ambulate even in a wheelchair without assistance, spending most of her time in bed, and had fractures of both legs. P. Ex. 5, at 5-11. On her MDS with a reference date of August 1, 2002, she had a slightly better rating of modified independence in decision-making, was able to maintain a sitting position, had a history of falls within the past 31-180 days, and this MDS predated the leg fractures. P. Ex. 5, at 12-17. Petitioner's care plan with an onset date of April 11, 2001 and an indication that it was purged on October 14, 2002 after the resident was returned from the hospital with two broken legs, is at P. Ex. 5 at 38. The care plan for falls indicates a history of falls and specifies that the resident requires an assist with transfers, that she is to be reminded to use the call light rather than attempting transfers herself, and that she is to be checked frequently for her needs. P. Ex. 5, at 38, 135-137. On October 9, 2002, Petitioner sent Resident 20 to a medical appointment outside the facility on the N.E.A.T. bus with no staff to supervise or assist her. While on the N.E.A.T. bus, Resident 20 fell from her wheelchair breaking both femurs. P. Ex. 5, at 64-66, 72, 81-82, 93-98.

Resident 21's care plan dated August 22, 2002, required that she have a minimal assist of one to two persons for all transfers, she was to be assisted with wheelchair mobility and monitored for positioning and repositioning as needed, her call light was to be kept in reach, she was to be monitored for safety and comfort, she was to be assisted to the bathroom every two to three hours, and a gait belt was to be used for a limited assist for ambulating. P. Ex. 6, at 32-34. The resident was also to be monitored for pain and given Vicodin. P. Ex. 6, at 47. A physician's order from July 2002, specified that she could go on outings with staff as she desired. P. Ex. 6, at 2. Her MDS dated August 8, 2002, shows that she was moderately impaired for decision-making, required limited assistance for transfers, did not walk, required extensive assistance for locomotion on and off the unit where she lived, had a history of falls in the last 30 days and the past 31-180 days with a hip fracture in the last 180 days, and was evaluated as having deteriorated compared to her status of 90 days ago. P. Ex. 6, at 4-10. She was evaluated by Petitioner's nursing staff as requiring assistance with transfers for safety, she was to be encouraged to request assistance with transferring as she had a known history of falls, and Petitioner had increased her supervision at night to prevent falls. P. Ex. 6, at 16, 18-19, 21, 27. The surveyors allege in the SOD that on October 27, 2002, the resident had difficulty breathing and her family asked that she have an x-ray to rule out pneumonia. CMS Ex. 1, at 21; P. Ex. 6 at 59-60. According to the SOD, on October 28, 2002, Resident 21 was sent out of Petitioner's facility for the x-ray at 10:00 a.m., transported by the N.E.A.T. bus unaccompanied by a staff member from Petitioner's facility. The SOD states that staff at the x-ray facility confirmed this. This staff person indicated that the resident could not stand and her family had to assist with the x-ray. The SOD alleges that, according to the x-ray facility, the bus normally drops residents off, the residents have no paper work, and they do not know why they are there. CMS Ex. 1, at 21-22. Petitioner does not dispute that the resident was sent to the appointment without staff to supervise or assist her. P. Brief at 14-15; P. Reply at 11-12.

Resident 24 had a physician's order that specified that she could go on outings with staff as desired. P. Ex. 7, at 1. Her MDS with a reference date of September 23, 2002, indicates that she had moderately impaired decision-making, she required extensive assistance for transfers, she was totally dependent on staff for locomotion on and off the unit, and she could not stand but could sit upright. P. Ex. 7, at 4-7, 29. Her care plan dated July 15, 2002, recognized her risk for falls due to decreased mobility and mental function and her need for total assistance with transfers and mobility. Her care plan required that she be monitored for side effects of her medication including drowsiness, dizziness, and lethargy; that she be transferred with total assist of one or two persons as she was non-weightbearing with particular care to avoid injury; and that her position in her wheelchair be checked every two to three hours with repositioning as necessary. P. Ex. 7, at 18, 40, 42. Her care plan dated July 15, 2002, also recognized her increased risk for pain and required that she be monitored for indications of increased pain, that she be administered medication per physician's orders for pain, and that she be monitored for signs and symptoms reflecting effectiveness of medication with reporting to the physician. P. Ex. 7, at 23. There is no dispute that Resident 24 went out of Petitioner's facility on October 30, 2002, to a physician's appointment for an "infected R great toe" (P. Ex. 7, at 38) unaccompanied on the N.E.A.T. bus by any member of Petitioner's staff.

Resident 29 was deaf and was diagnosed as having senile dementia, depression, paranoia, and hypertension. P. Ex. 8, at 1, 24; CMS Ex. 26, at 6. She had a physician's order that provided that she may go on outings with staff as desired. P. Ex. 8, at 1. The resident's MDS with a reference date of September 10, 2002, indicates that she was moderately impaired for decision-making, verbally abusive and socially inappropriate daily, required extensive assistance for transfers, and could not walk or stand. P. Ex. 8, at 4-7, 23. Her care plan dated June 21, 2002, required that she be redirected when she became verbally abusive; she was to be repositioned in her wheelchair every two to three hours; she was to be assisted in the bathroom to prevent self-transfers due to her increased risk for falls; staff was instructed to use clear concise speech due to her deafness; she was to be monitored for side-effects of her medication; and she was to be assisted to activities such as bingo, church services, and sing-a-long due to her propensity to become abusive and threatening. P. Ex. 8, at 8-22. There is no dispute that Resident 29 went out of Petitioner's facility on October 9, 2002 and November 6, 2002 to physician appointments. P. Ex. 8, at 25, 30. The SOD indicates that the surveyor interviewed the social worker who reported that he accompanied the resident to the November 6, 2002 appointment because the physician would not see her unless a staff member was with her. The surveyor contacted the physician's office and was advised that Petitioner had sent Resident 29 to previous appointments alone without staff. The office reported that the resident was too much to handle and that her behavior frightened other patients in the waiting room. CMS Ex. 1, at 23. Petitioner does not dispute the allegations regarding the report of the social worker or the physician's office. P. Brief at 15-16; P. Reply at 12-13.

Resident 9's MDS with a reference date of December 6, 2002, indicates that the resident was moderately impaired for decision-making, required supervision with transfers, required supervision for walking and locomotion on and off the unit, required partial physical support for standing, and he had a history of falls in the past 31 to 180 days with a hip fracture. P. Ex. 3, at 100-04. His MDS with a reference date of September 25, 2002, indicates that he was moderately impaired for decision-making, required limited assistance for transfers and walking in the corridor, was totally dependent for locomotion on and off the unit with a wheelchair being the primary means of locomotion, was unable to stand without physical help, and had a history of falls in the last 30 days with a history of hip fracture. P. Ex. 3, 105-12. Resident 9's care plan stated that he required assistance with transfers and most activities of daily living (ADLs), he was to be assisted to the bathroom every one to two hours and on request, and he was to be assisted with repositioning in his wheelchair every two to three hours. The care plan recognized his risk for yelling and striking out and staff was to monitor and diffuse as necessary. He was to be monitored for side-effects of medication and illnesses, he was to be monitored and assessed for pain and given pain medications as ordered, and his oxygen saturation was to be monitored with oxygen administered to maintain saturation above 90 percent. P. Ex. 3, at 3-6, 11-15, 19. Petitioner's records for Resident 9 show that he fell on August 23, 2002. P. Ex. 3, at 24-26. He fell again on October 15, 2002. P. Ex. 3, at 31-35. The resident's care plan dated September 16, 2002, stated that he required assistance with all ADLs to provide safety, he was to be monitored for pain and side effects as with the prior plan, hallways were to be kept clear of clutter, staff was to ensure that he had appropriate shoes and that his pant legs did not extend below his shoes, he was to be monitored to prevent self-transfers but this intervention was discontinued on some unspecified date, he was to be kept in a supervised area when up to decrease falls. P. Ex. 3 at 73-74. The resident fell again on November 10, 2002. P. Ex. 3, at 76-79. It is undisputed that on November 4, 2002, Resident 9 was sent for a left hip x-ray on the N.E.A.T. bus without a member of Petitioner's staff to supervise or assist. CMS Ex. 1, at 24; P. Brief at 16; P. Reply at 12-13.

Each of the five residents was assessed and a care plan was developed for each by Petitioner. The question under Tag 309 is whether or not Petitioner provided the care and services it determined necessary through the comprehensive assessments and then set out in each resident's plan of care with the goal that each resident would attain or maintain the highest practicable physical, mental, and psychosocial well-being. Considering each resident's MDS and the risks assessed by Petitioner; considering each resident's plan of care and the service Petitioner undertook to deliver based upon assessed needs; and then considering that Petitioner put each of these residents on the N.E.A.T bus without at least one or more of Petitioner's staff on board to ensure that the plan of care was fulfilled, it is abundantly clear that Petitioner was not delivering care and services it determined necessary for those residents to attain or maintain their highest practicable states. Thus, Petitioner was in violation of 42 C.F.R. � 483.25 with regard to the examples cited.

CMS might also have cited these examples as violations of the more specific quality of care requirement established by 42 C.F.R. � 483.25(h)(2) (adequate supervision and assistance devices to prevent accidents). Pursuant to 42 C.F.R. � 483.25(h)(2), a facility must ensure "[e]ach resident receives adequate supervision and assistance devices to prevent accidents." 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 of 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. Appx. 843, No. 04-3018 slip op., 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)." CMS Ex. 101, at 118; Woodstock Care Center, DAB No. 1726, at 4 (2000).

The evidence presented is sufficient to constitute a prima facie showing that Petitioner failed to provide the necessary supervision to Residents 20, 21, 24, 29, and 9 to prevent accidents. Petitioner's records, specifically the assessments and care plans for each resident, show that Petitioner was well aware of the risks to each resident. Furthermore, it is clear from Petitioner's assessments and other records that these residents had little or no ability to protect themselves. By placing these residents on the N.E.A.T. bus without the supervision of its trained staff, Petitioner failed to minimize the risks. In the case of Resident 20, actual harm occurred. CMS Exs. 20, 21, 23, 26, and 12; P. Exs. 5, 6, 7, 8, and 3.

In its defense, Petitioner claims that it did provide safe transportation. Petitioner also asserts that there is no regulation requiring the facility to provide an assistant for residents who use the N.E.A.T. bus. Petitioner contends further that it had no duty to the residents once they were placed on the N.E.A.T. bus, asserting that it was the responsibility of the N.E.A.T. bus employees to safely transport the residents to their respective appointments. P. Brief at 13, 16. Furthermore, Petitioner asserts that it had staffing constraints and therefore it was "not possible" to send staff with residents on the N.E.A.T. bus. P. Rep. Brief at 9.

I find Petitioner's arguments to be without merit. Certainly there is no regulation of the Secretary that addresses placing the residents of long-term care facilities on buses for transportation, with or without qualified staff to care for and supervise at-risk residents. But as already discussed, there is the quality of care regulation which I find Petitioner specifically violated by placing these particular residents on the N.E.A.T. bus unsupervised and contrary to assessed needs and their plans of care.

With respect to Resident 20, actual harm occurred. Petitioner attempts to blame her accident on the fact that the N.E.A.T. bus driver did not use the shoulder strap on the resident. ⁽⁸⁾ Petitioner states in its brief, "[t]he preponderance of the evidence indicates that Resident #20's injury was directly caused by COACH USA's failure to utilize the shoulder strap . . . The facility had absolutely no control over whether COACH USA utilized the shoulder belt . . . the facility cannot be held responsible for this." P. Brief at 14. Petitioner further asserts that two staff members met Resident 20 at her physician's appointment, "so not even a potential for minimal harm was present." P. Brief at 14. But, the issue here is not whether or not the N.E.A.T. bus driver was doing his or her job. The issue is whether or not Petitioner, by placing these residents on the N.E.A.T. bus unaccompanied by qualified staff, was delivering the quality of care it assessed necessary and planned to provide as required by the regulation. Even more specifically, was Petitioner providing for the safety of the residents and ensuring that the specific interventions of their care plans were being fulfilled, when they were given over to the N.E.A.T. bus driver for transportation? Clearly Petitioner was not fulfilling its regulatory obligations to these residents. The fact that Resident 20 was met by two staff members at her appointment is irrelevant. By the time Resident 20 arrived at her physician's office, she had already slid out of her wheelchair on the N.E.A.T. bus, and unbeknownst to anyone at the time, fractured both knees. One must ask how Petitioner was able to send two staff members (one of whom was a CNA) in the facility van to meet Resident 20 at the physician's office, and yet could not be bothered with sending one or both of them to accompany Resident 20 on the N.E.A.T. bus. In fact, after the appointment, because the resident was crying and in severe discomfort, the staff members transported her back to Petitioner's facility in the facility van. CMS Ex. 20, at 34, 36.

With respect to the other four residents, while the evidence does not show that they suffered actual harm, I conclude that Petitioner did not provide the quality of care assessed necessary and planned for and did not minimize the risk of accidents to the extent reasonably possible. Like Resident 20, these other four residents had histories of falls or were assessed as being at risk for falls. ⁽⁹⁾ They were diagnosed to be suffering from confusion (Resident 21), organic brain syndrome (Resident 24), senile dementia and paranoia (Resident 29), and Alzheimer's disease (Resident 9), and each was assessed as needing assistance and supervision. CMS Exs. 21, 23, 26, and 12; P. Exs. 6, 7, 8, and 3. In sending these residents to their medical appointments unaccompanied on the N.E.A.T. bus, I find that Petitioner put them at risk of more than minimal harm due to their vulnerable physical and psychological conditions.

Both Vicki Hutchings, Petitioner's former director of social services, and Audra Dana, an operations manager at Coach USA, testified that they had concerns about the residents' safety on the N.E.A.T. bus, and had spoken to Petitioner's staff about providing a staff person to accompany them on the bus. ⁽¹⁰⁾ Tr. 186, 187-88, 295-97. Ms. Hutchings testified that family members expressed their concerns to her about residents being unattended during N.E.A.T. bus transportation, and several physicians complained also about residents who came without a staff member. ⁽¹¹⁾ Tr. 298. According to Ms. Dana, when Coach USA first started transporting residents for Petitioner, Petitioner supplied an attendant with every resident. Tr. 182-83. However, this practice deteriorated and Petitioner eventually stopped supplying staff to accompany the residents. Tr. 184. Ms. Dana testified that sometimes, a staff member from Petitioner's facility would "show up" at the physician's office, but other times, no one would be there. If no one was there to meet the resident, the N.E.A.T. bus driver would take the resident into the office even though the driver was not supposed to do this. Tr. 185.

Petitioner asserts in its briefs that it was the responsibility of Coach USA and/or the residents' families to ensure that Resident 20 and the other residents were transported safely to their appointments. I find this argument to be totally without merit. Petitioner accepted responsibility for these residents when it accepted them for care and it has legal responsibility for them based upon its participation in the Medicare program. Petitioner cannot avoid its duty by the simple expedient of sending the residents outside the facility on non-facility transportation. Petitioner, not the employees of Coach USA or the residents' family members, was under the obligation to ensure that the residents were safely transported to their medical appointments or arrangements made for them to be seen at the nursing facility. By sending the five residents unsupervised on the N.E.A.T. bus, Petitioner clearly abdicated its duty to provide the necessary care and services to all residents, in violation of 42 C.F.R.
� 483.25.

Petitioner's assertion that it could not send staff with residents on the N.E.A.T. bus because it had a staff shortage is nearly as offensive as the notion it could simply avoid responsibility by handing the patients off to someone. Under 42 C.F.R. � 483.30, a facility has a duty to have sufficient nursing staff to provide nursing and related services to attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident. Thus, Petitioner cannot use inadequate staffing as a justification for its failure to provide staff to accompany residents. If Petitioner was able to send two staff members off the premises in its own van to meet Resident 20 at her physician's appointment, adequacy of staffing was obviously not the issue in that instance.

b. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) because it failed to comply with Resident 26's care plan and physician's order to administer laxatives during the period November 7 through 12, 2002 and Resident 26 suffered actual harm, and because it failed to provide foley catheter care as ordered and care planned for Resident 10.

Resident 26 was an 89-year-old female admitted to the facility on April 3, 2001. Her diagnoses upon admission included Alzheimer's disease, dementia, and she had a history of right hip fracture. CMS Ex. 24, at 15. Resident 26's MAR documented a physician's order for 30 cc's of Milk of Magnesia when the resident had not had a bowel movement for three days and an order for a 10 mg Bisacodyl suppository when there was no bowel movement for four days. P. Ex. 9, at 18-19; CMS Ex. 24, at 16, 38. Nurse's notes show that on November 12, 2002, the resident's daughter complained about the resident "grimacing and holding stomach" and that Resident 26 last had a bowel movement during the evening shift on November 7, 2002. P. Ex. 9, at 1, 3. The nurse's notes show that staff administered a Dulcolax (Bisacodyl) suppository on November 12, 2002, at 1:45 p.m., more than four days from her last documented bowel movement. P. Ex. 9, at 1. Resident 26 is documented to have had her next bowel movement during the evening shift on November 12, 2002. P. Ex. 9, at 3-4. There is no indication that Milk of Magnesia was provided to the resident as ordered after she passed three days without a bowel movement.

The evidence shows that Resident 26 did not have a bowel movement between the evening of November 7, 2002 through the evening of November 12, 2002. P. Ex. 9, at 3-4; CMS Ex. 24, at 33-34; Tr. 451-52. During this span of five days, Petitioner's staff failed to administer Milk of Magnesia and Bisacodyl in accordance with her physician's orders. Tr. 452-53. Had staff complied with the orders, they would have given the resident Milk of Magnesia on November 10, 2002, the third day without a bowel movement, and they would have given her a Bisacodyl suppository on November 11, 2002, the fourth day the resident had not had a bowel movement. Tr. 452-53.

Petitioner admits that its staff was one day late in administering Bisacodyl to Resident 26. P. Brief at 18; P. Reply at 13; P. Ex. 9, at 19. Petitioner contends, however, that "[s]uch a slight error is insignificant" and disputes that actual harm occurred. P. Brief at 18. Petitioner does not address its staff's failure to give the resident Milk of Magnesia during the five-day span. Petitioner argues, in effect, that the failure to comply with the resident's care plan did not create the potential for even minimal harm to the resident. However, the unrebutted evidence shows that, as a result of her untreated constipation, Resident 26 suffered abdominal pain and/or discomfort, which amounts to actual harm. Furthermore, Surveyor Stewart gave unrebutted testimony that constipation can lead to fecal impaction that can result in serious medical problems. Tr. 453. Ms. Stewart stated that fecal impactions are a concern with the elderly, and is an area that surveyors pay close attention to when conducting surveys. Tr. 453-54.

Based on the evidence, I find that Petitioner failed to provide the necessary care and services for Resident 26 to allow her to attain or maintain the highest practicable physical well-being in accordance with her plan of care, in violation of 42 C.F.R. � 483.25.

Resident 10's condition has already been briefly reviewed in the context of Tag F 281 and the failure to use a lift for transfers. Under Tag F 309, the surveyors allege that Resident 10 had a physician's order for Foley catheter care each shift. CMS Ex. 1, at 26; CMS Ex. 13, at 16. The SOD alleges that the MAR failed to document any Foley catheter care during the "2-10" and "10-2" shifts from November 1 through November 11, 2002, and there was no Foley catheter care documented at all on November 2 and 3, 2002. CMS Ex. 1, at 26; CMS Ex. 13, at 16. Resident 10's care plan required that the catheter tubing was to remain off the floor to prevent infection; however, the surveyors observed the tubing dragging on the floor on November 12, 2002. CMS Ex. 1, at 26.

My review of Resident 10's records shows that she had physician's orders for staff to change her Foley catheter monthly and provide catheter care on each shift, including daily irrigation with 30 cc's of normal saline, and checking for patency (making sure the catheter is not clogged). CMS Ex. 13, at 16, 117; Tr. 459. ⁽¹²⁾ Additionally, her care plan specifically noted that catheter care was to be provided and that the catheter tubing was to be kept "off the floor to prevent infection." CMS Ex. 13, at 24; P. Ex 10, at 116.

Petitioner argues that Resident 10 did receive appropriate catheter care. As support for this contention, Petitioner points to a form titled "Daily Documentation List - CNA," dated November 2002. P. Ex. 10, at 334. This form lists several categories along the left-hand margin, one of which is "Voiding." Within this category, there are four sections: "Bladder Program," "Continent - # of times," "Incontinent - # of times," and "Catheter." P. Ex. 10, at 334. Petitioner cites the testimony of Joyce Stapleton, a consultant hired by Petitioner in November 2002, who assisted the staff in writing Petitioner's plans of correction. Tr. 548-49. Ms. Stapleton testified that the entries (i.e. check marks in boxes) next to "Catheter" on the form during the period November 1 through 11 were made by the CNAs and document that Resident 10 did have a catheter and that the CNAs had provided catheter care on the days and shifts where checked. Tr. 551. CMS contends that Petitioner has mischaracterized the evidence, and offers the testimony of its surveyor, Ms. Stewart, who contradicted Petitioner's interpretation of the "Daily Documentation List - CNA." Ms. Stewart explained that the check marks on the form did not indicate that catheter care was done, only that a catheter was present. Tr. 461-64.

It is not necessary to determine whether I find Ms. Stewart's or Ms. Stapleton's testimony to be more credible. The physician's order required catheter care every shift and P. Ex. 10, upon which Petitioner relies, clearly shows no catheter care or catheter check was done on various shifts on November 2, 5, 8, 10, 23, 26, 27, 28, 29, and 30, 2002. P. Ex. 10, at 335-38. Petitioner has not explained these gaps in care. By failing to comply with the physician's orders regarding foley catheter care, I conclude that Petitioner failed to provide Resident 10 with necessary care and services in violation of 42 C.F.R. � 483.25.

With respect to Resident 10's catheter tubing, Petitioner does not dispute that it was dragging on the floor. Petitioner contends, however, that a catheter tube "touching the floor for a short period of time" is not evidence of a deficient practice under Tag F 309 because it was "unavoidable due to resident movement." P. Rep. Brief at 13; P. Brief at 18. I find this argument to be unpersuasive. Resident 10's care plan explicitly stated that her catheter tubing was to be kept "off the floor to prevent infection." CMS Ex. 13, at 24; P. Ex. 10, at 116. During the survey, Ms. Stewart observed the resident in her wheelchair with her catheter tubing dragging on the floor. Tr. 455-57. She testified that the tubing would become contaminated, and put the resident at increased risk of having a bladder infection. Tr. 455-56. Ms. Stewart stated further that by being on the floor, the tubing could get bent and become obstructed, or it could become dislodged, possibly causing severe injury to the resident. Tr. 456-57. By allowing Resident 10's catheter tubing to drag on the floor, Petitioner violated a care plan directive. Based on the unrebutted evidence, I conclude that Petitioner failed to provide the necessary care and services for Resident 10 to allow her to attain or maintain the highest practicable physical well-being in accordance with her plan of care, in violation of 42 C.F.R. � 483.25.

c. Petitioner violated 42 C.F.R. � 483.25 (Tag F 309) by failure to comply with the requirements of Resident 10's pain care plan on November 13 and 14, 2002 and Resident 10 suffered actual harm; Petitioner did not violate 42 C.F.R. � 483.25 (Tag F 309) with regard to pain management for Resident 15, including assessment, monitoring, planning, and implementing the plan.

The surveyors also allege with regard to Residents 10 and 15 that Petitioner violated the regulation by failing to adequately assess them for pain and develop a pain management program to meet their needs. CMS Ex. 1, at 16, 27-32.

With respect to Resident 10, the gist of the allegations by the surveyor is that she observed that Petitioner did not comply with the care plan requirements to manage pain by repositioning the resident in bed or chair every two hours, by observing for signs of pain, and relieving her pain by having her lie down. CMS Ex. 1, at 27-29.

The evidence demonstrates that Petitioner failed to follow Resident 10's care plan and failed to effectively manage the resident's pain levels. Surveyor Stewart testified that, on November 13, 2002, she observed the resident at breakfast around 7:30 a.m., and continued to observe her after she was taken back to her room around 8:45 a.m. Tr. 402. Ms. Stewart stated that the resident was basically left to sit in her room, with her back facing the doorway. ⁽¹³⁾ Tr. 402-03. She observed that the call light was on the far side of the resident's bed. Tr. 402. Around 10:15 a.m., Ms. Stewart observed that the resident appeared to be in pain. The resident said she was in pain and would like to lay down. Tr. 403, 407. The resident indicated that she was unable to call for aid because the call light was out of her reach. Ms. Stewart asked staff to assist Resident 10, at which time they went into her room and assisted her. Tr. 404. According to Ms. Stewart, the resident had been sitting in her wheelchair since 7:30 a.m. Tr. 439.

Ms. Stewart observed Resident 10 again the next day, November 14, 2002. Tr. 405. She stated that when Resident 10 was brought back to her room, the call light was again out of her reach, and the resident was left for an extended period of time. Ms. Stewart testified that she observed the resident grimacing, and the resident said she was in pain, and that she wished to lay down. Tr. 405, 407. According to Ms. Stewart, the resident was unable to call for assistance because she could not reach her call light. Ms. Stewart again asked staff to lay the resident down. Tr. 406, 407. She testified that failure to reposition Resident 10 every two hours, as required by her care plan, would likely increase the pain level that the resident experienced. Tr. 438-39.

In its posthearing briefing, Petitioner contends that it adequately assessed Resident 10 for pain and developed a pain program but never specifically addresses the surveyor allegations. P. Brief at 19-21; P. Reply at 15. Petitioner has presented no evidence that contradicts Ms. Stewart's testimony about her observations on November 13 and 14, 2002. Based on CMS's unrebutted evidence, I conclude that Petitioner neither monitored Resident 10's pain and grimacing nor provided her with adequate pain management as required by her care plan and assessments. The evidence shows that Petitioner's staff failed to implement the interventions that had been identified to manage and alleviate Resident 10's pain. Accordingly, I conclude that Petitioner failed to provide Resident 10 with the care and services that she needed, in violation of 42 C.F.R. � 483.25.

The surveyors allege in the SOD that Petitioner failed to adequately monitor and assess Resident 15 for pain; adequately care plan a method that would alleviate her pain secondary to serious skin ulcers including coordinating administration of medication with wound care to achieve maximum pain relief; document and communicate with her physician regarding pain management; and monitor and document the effectiveness of pain medication. CMS Ex. 1, at 30, 32. The surveyors allege that as a result the resident experienced unnecessary pain during dressing changes. CMS Ex. 1, at 29-32. The surveyor's allegations are based upon a records review and there is no indication of any direct observation of wound care by the surveyor. The surveyor's notes indicate that she did observe the resident for two days but the only written note regarding the observation is that the resident was not offered fluids between meals and the urine in her catheter was dark amber. CMS Ex. 17, at 4. Surveyor Christine Rushing, who prepared the allegations under Tag F 309 regarding Resident 15, testified that based on the nature of the pressure sores Resident 15 had, dressing changes would be very painful. Tr. 352-54. Ms. Rushing testified that a member of Resident 15's family told her she was concerned that Resident 15 was not getting the pain relief she required and expressed concern regarding medication changes. Tr. 355-56.

According to Resident 15's care plan, dated September 6, 2001, ⁽¹⁴⁾ she was at high risk for pain and appeared to be "in actual pain from her decubitus ulcers, especially during dressing changes." The care plan required that she be monitored for increased signs and symptoms of pain, that effectiveness of pain medication be monitored, that the doctor be notified if pain was not controlled, and that the resident be repositioned every two to three hours or more frequently as needed. CMS Ex. 17, at 8-9.

I find that the surveyor's allegations regarding care planning, monitoring, and communicating with Resident 15's doctor are not supported by the record. In fact, review of CMS Ex. 17 and P. Ex. 11 shows that there was a pain care plan. Further, while documentation may not have been as extensive as the surveyor desired, it is clear that the resident's pain was monitored and her doctor advised given the number of pain medication adjustments and changes made. My review of the nursing notes shows two instances documented, one October 28, 2002 (CMS Ex. 17, at 22, 29) and November 4, 2002 (CMS Ex. 17, at 23, 30) where the resident apparently experienced more severe pain during dressing changes. The surveyor concluded these two documented instances show that pain medication was not effective and the plan of care was not followed rather than concluding that these were the only two instances during the period she reviewed where there was breakthrough pain that was properly noted and acted upon consistent with the plan of care. However, the record does not support the surveyor's conclusion. Resident 15 did receive pain medication on October 28, 2002 and November 4, 2002, and her breakthrough pain was properly recorded in the nursing notes as discussed hereafter.

Petitioner asserts that the record shows that Resident 15 did receive MS Contin as ordered on October 28, 2002, and did receive liquid morphine on November 4, 2002, at 8:00 a.m. Petitioner contends further that the liquid morphine the resident received on November 4 still would have been effective at the time of her dressing change, which would have started around 11:00 a.m. P. Brief at 19-20. The record supports Petitioner's position.

With respect to the October 28, 2002 dressing change, I am persuaded that the evidence shows that Resident 15 received pain medication on that day. CMS's witness, Ms. Rushing, initially testified that, based on her review of the resident's October 2002 MAR (CMS Ex. 17, at 42), Demerol, Vicodan, and the Duragesic patch had all been discontinued prior to October 28^th, and she could not find any evidence of pain medication being administered on October 28. Tr. 369. However, in response to my questioning, Ms. Rushing acknowledged that a nursing note dated October 24, 2002, contained a physician's order to discontinue the Duragesic patch and start "MS Contin 15 mg BID." Tr. 380; CMS Ex. 17, at 23; P. Ex. 11, at 37. I directed Ms. Rushing's attention to CMS Ex. 17, at 58, which is another MAR. In response to my questions about this particular document, Ms. Rushing conceded that it was possible that certain handwritten changes with respect to the days of the month were meant to indicate October 2002 dates. ⁽¹⁵⁾ Tr. 380-82. She then conceded that it was more likely than not that Resident 15 did receive pain medication on October 28, 2002, in the morning and evening. Tr. 383-84.

As for the November 4, 2002 dressing change, I find that the testimony and evidence also indicate that Resident 15 received pain medication on that day, as ordered. At the hearing, Ms. Rushing was questioned regarding the resident's November 2002 MAR, which lists both MS Contin and liquid morphine in the medications column. She testified that, according to a notation on the document, liquid morphine was substituted for MS Contin because MS Contin was not available. Tr. 388, 393-94; CMS Ex. 17, at 47; P. Ex 11, at 43.

Concerning MS Contin, Ms. Rushing testified that, because the "0800" and "1700" (5:00 p.m.) boxes contain initials that are circled, this meant that MS Contin was not administered to the resident. Tr. 368; CMS Ex. 17, at 47. According to Ms. Rushing, it is standard nursing practice to circle initials if a resident refuses medication. Tr. 386-87; 389. Ms. Rushing's testimony pertains to the period November 4 to 12, 2002, and is consistent with the fact that the MAR contains the instruction to "circle initials when medication or treatment is refused." CMS Ex. 17, at 48; Tr. 387. What is not entirely clear from her testimony or the record, however, is whether the MS Contin was offered to Resident 15 in the first place on November 4-12, 2002, and then refused by her. Ms. Rushing would have me conclude that MS Contin was not available, and staff circled their initials in the boxes to indicate that it was not administered. Tr. 390-91. Whatever the motivation behind the circled initials for MS Contin, it appears that this pain medication was not available and was not given to Resident 15.

With respect to the liquid morphine, Ms. Rushing testified that Resident 15 received this pain medication only once on November 4, 2002. She then changed her testimony, stating that the resident also received it again later that day. Ms. Rushing stated that the MAR shows that the resident received 40 mg of liquid morphine at 8:00 a.m. on November 4, 2002. Tr. 368. Noting what looked like circled initials in the "1700" (5:00 p.m.) box, Ms. Rushing initially testified that this meant that Resident 15 had refused liquid morphine at that hour. Tr. 368. However, Ms. Rushing later stated that it appeared that the initials were not circled. Tr. 391. When I asked Ms. Rushing if she would conclude that morphine was given to the resident at 1700 hours on November 4, 2002, she responded, "I would say that it was." Tr. 391. Ms. Rushing then testified that the resident probably did receive morphine "at 08 and 1700." Tr. 392.

I am also not persuaded by CMS's argument that Petitioner's administration of the medication did not correspond to the times when the resident experienced the most pain. On cross-examination, Ms. Rushing testified that, although the entry for the November 4, 2002 dressing change was written at 11:30 a.m., the dressing change itself would have begun around 11:00 a.m. Tr. 396. Given that the liquid morphine was administered at 8:00 a.m. on November 4 and lasts for three or four hours, the testimony of Ms. Rushing supports a conclusion that the medication would still have been effective at the time the resident received a dressing change. Tr. 394-96. Moreover, Ms. Rushing testified that it is not unusual for a resident to complain of pain during a dressing change even after receiving pain medication. Tr. 378; Tr. 384-85. In response to my questioning, she stated further that if the resident experienced breakthrough pain despite having received her pain medication as ordered, she would not cite this as deficient care. Tr. 378-79. ⁽¹⁶⁾

The evidence does not support a conclusion that Petitioner's care of Resident 15 was deficient in the area of pain management or that Petitioner violated 42 C.F.R. � 483.25 as alleged.

The surveyor also alleges in the SOD that Resident 15's physician ordered hospice services for the resident on September 3, 2002. According to a social worker, only a few hospice visits had taken place as of the survey. The social worker stated that the local hospice is volunteer-run and the agency had difficulty providing needed services. The SOD alleges that the physician was not notified that hospice services were not being supplied. The SOD alleges further that a staff person could not find evidence in the record of any hospice visits. CMS Ex. 1, at 31.

CMS does not address this allegation in its posthearing briefing. Petitioner acknowledges that Resident 15 had a physician's order in place for hospice services. P. Brief at 20; P. Ex. 11, at 51; CMS Ex. 17, at 49. Its former Administrator, Fred Stapleton, testified that he agreed with the statement in the SOD that the hospice agency had difficulty providing needed services. Tr. 531. According to Mr. Stapleton, the hospice program in Petitioner's area was a volunteer program, with only one paid staff person, a social worker. Tr. 530-31. Mr. Stapleton stated that the hospice program did not have licensed nursing staff to provide care and that the services provided consisted of a volunteer coming to the facility and giving moral support to the resident and family. Tr. 531. Joyce Stapleton, the consultant hired by Petitioner, gave testimony that one person did visit Petitioner's facility on a very infrequent basis, and the primary purpose of the visits was to provide companionship. Tr. 554-55. Petitioner, pointing out that hospice services in the area were extremely limited, argues that it did all it could to coordinate hospice services for Resident 15. P. Brief at 20. I conclude that Petitioner did what it could to coordinate hospice services and the evidence shows that some services, albeit limited, were provided as ordered by Resident 15's physician.

Accordingly, I conclude that Petitioner did not violate 42 C.F.R. � 483.25, as alleged by CMS with respect to Resident 15.

3. A per instance CMP of $2500 for Petitioner's noncompliance under Tag F 281, and a per instance CMP of $2500 for Petitioner's noncompliance under Tag F 309 are not reasonable; however, a per instance CMP of $2000 for Petitioner's noncompliance under Tag F 281, and a per instance CMP of $2000 for Petitioner's noncompliance under Tag F 309 are reasonable.

I must also consider whether the amount of the CMPs imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). Emerald Oaks, DAB No. 1800, at 10 (2001); CarePlex of Silver Spring, DAB No. 1683, at 16-17 (1999); Capitol Hill Community Rehabilitation and Specialty Care Center, DAB No. 1629 (1997). In reaching a decision on the reasonableness of the CMP, I do not look into CMS's internal decision-making process. Instead, I consider whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved (financial condition, facility history, and culpability). CarePlex, DAB No. 1683, at 8. I am neither bound to defer to CMS's factual assertions, nor free to make a wholly independent choice of remedies without regard to CMS's discretion. Community Nursing Home, DAB No. 1807, at 25 (2002); CarePlex, DAB No. 1683, at 17-18.

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 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.

In this case, CMS urges that I uphold the imposition against Petitioner of two separate per instance CMPs, in the amounts of $2500 each, for the deficiencies identified under Tag F 281 and Tag F 309. CMS maintains that measured against the applicable factors, the CMPs are reasonable. Petitioner contends that, if CMPs are required to be imposed, I should reduce them to the minimum per instance amounts of $1000 each.

CMS asserts that Petitioner has a history of non-compliance and was found to be previously deficient under Tag F 281 and Tag F 309 at a prior survey. As support, CMS cites an OSCAR report (CMS Ex. 43), which is a document that lists a facility's prior compliance history. The report shows that at a November 2001 survey Petitioner was found to be out of compliance with several tags, including Tag F 281 and Tag F 309, the tags at issue in this case. CMS Ex. 43. At the November 2001 survey, Tag F 281 was cited at the "D" level, and Tag F 309 was cited at the "E" level. ⁽¹⁷⁾ CMS Ex. 43. I find that Petitioner does have a history of past noncompliance. Petitioner was under different management at the time of the November 2001 survey. Furthermore, and more significantly, it is not possible to determine the factual basis for the prior citations of tags that have a very broad scope and might encompass many different failings of a facility. Thus, I give minimal weight to Petitioner's history of noncompliance.

Petitioner has not argued that it is without the financial means to pay the CMPs. Nor has Petitioner submitted any evidence with respect to its financial condition. Therefore, I do not consider Petitioner's financial condition in analyzing the reasonableness of the CMPs.

In determining the serious of Petitioner's deficiencies, I must consider whether the deficiencies constituted actual harm. 42 C.F.R. � 488.404(b). As discussed above, I found that Petitioner's noncompliance did result in actual harm. Under Tag F 281, Surveyor Stewart suggested in her testimony (Tr. 413, 436-37) there was no actual harm, but she clearly testified that she witnessed Resident 10 suffer pain with the transfer, which clearly amounts to actual harm. Under Tag F 309, Petitioner's failure to ensure its residents' safety when they were transported to appointments resulted in actual harm to Resident 20, who suffered fractures of both her knees while riding the N.E.A.T. bus unaccompanied by a staff member. Also under Tag F 309, Resident 26 and Resident 10 both experienced pain due to Petitioner's failure to follow their care plans.

With respect to Tag F 309, Petitioner notes that this tag's scope and severity level was initially cited at the "H" level, but was then lowered by CMS to a level "G" deficiency. Petitioner argues that the per instance CMP amount of $2500 was based on the tag having a "H" scope and severity level, and should have been reduced when the scope and severity level was changed to a level of "G." P. Brief at 23. Petitioner's argument is unavailing. It is not for me to review how CMS exercises its discretion and determines the amount of a CMP to propose. When evaluating whether a CMP is within a reasonable range, I do not look into CMS's internal decision-making process. I do of course consider that as to both tags in dispute before me, CMS has not prevailed in showing the alleged deficiencies were as extensive as originally alleged.

The last factor for me to consider is Petitioner's culpability. The term "culpability" is defined at 42 C.F.R. � 488.438(f)(4) to include "but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety." The evidence supports the conclusion that Petitioner was culpable. Although certain interventions and orders were in the residents' care plans based on their assessed needs, Petitioner's staff failed to ensure that these interventions and orders were followed. Additionally, Petitioner's failure to provide residents with supervision when they took public transportation, despite having been alerted of safety concerns, demonstrated indifference for their safety and welfare. Petitioner abdicated its duty toward the residents it put on the N.E.A.T. bus, and it was culpable.

I consider my finding that there was no deficiency as to Resident 19 under Tag F 281, and conclude adjustment of the CMP is appropriate. A further adjustment is appropriate based upon my conclusion that a deficiency has not been proved regarding Resident 15 under Tag F 309. Accordingly, considering all the factors, I reduce the per instance CMP as to Tag F 281 from $2500 to $2000 and for Tag F 309, I reduce the CMP from $2500 to $2000.

III. Conclusion

For the foregoing reasons, I conclude that Petitioner violated 42 C.F.R. � 483.20(k)(3)(i) (Tag F 281) and 42 C.F.R. � 483.25 (Tag F 309) and there is a basis for the imposition of remedies. A per instance CMP in the amount of $2000 for each violation 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 survey, unless otherwise indicated.

2. This is a "Tag" designation as used in the State Operations Manual (SOM), Appendix PP - Guidance to Surveyors for Long Term Care Facilities. The verison of the SOM in effect during this survey was admitted as evidence as CMS Exhibit 101. The "Tag" refers to the specific regulatory provision allegedly violated and CMS's guidance to surveyors. Although the SOM does not have the force and effect of law, the provisions of the Act and regulations interpreted clearly do have such force and effect. State of Indiana by the Indiana Department of Public Welfare v. Sullivan, 934 F.2d 853 (7^th Cir. 1991); Northwest Tissue Center v. Shalala, 1 F.3d 522 (7 ^th Cir. 1993). Thus, while the Secretary may not seek to enforce the provisions of the SOM, he may seek to enforce the provisions of the Act or regulations as interpreted by the SOM.

3. The parties executed a prehearing stipulation on October 14, 2003 (Ct. Ex. 2), in which they agreed, based upon their narrowing of issues for adjudication, that the following CMS exhibits would not be offered or considered as evidence: CMS Exs. 7-11; 14-16; 18; 25; 27; 30-31; 33; 36; 45-71; 74; 78-90; 92-93; and 95-99. The transcript erroneously indicates that CMS Ex. 27 was offered and admitted as evidence and omits that CMS Ex. 28 was offered and admitted as evidence. Tr. 28-29. The parties also stipulated that CMS was not proceeding on the examples of Residents 9 and 16 cited under Tag F 281, the alleged violation of 42 C.F.R. � 483.20(k)(3)(i), which examples had been removed by the informal dispute resolution process. CMS Ex. 2.

4. The evidence does not show that there was actually a fire in the facility. CMS's witness, Dora Goddard, testified that, although something smelled "hot," she did not see a fire and could not recall seeing any smoke. Tr. 107, 117. CMS's witness, Surveyor Cavanagh, said she did not see any documentation of a fire. Tr. 155, 224; Tr. 221-22. Of course, unless it is clear that there is no fire, it is the task of the fire department to determine whether there is a fire and the task of facility staff is to protect residents when there is a fire alarm.

5. Based upon descriptions from the witnesses at trial, the Hoyer (a brand or manufacturer's name) or a Hoyer-type lift is a mechanical lift with wheels and a sling in which a patient is placed and then moved without the need for a staff member to physically lift the patient. Tr. 89-90, 91, 99. Invacare is another manufacturer of similar lifts. Tr. 81.

6. CMS also alleges that Petitioner's records show transfers of Resident 19 on several other occasions "with assist" rather than "with lift." CMS Prehearing Brief at 12; CMS Brief at 5. However, the additional allegations by counsel for CMS were not cited as deficiencies by the state agency in the SOD at CMS Ex. 1. Thus, it is clear that those allegations were not the basis for the imposition of any remedy in this case. Nor can it be argued that Petitioner was notified of those allegations as contemplated by the regulations. See 42 C.F.R. � 488.330. If CMS determines that it is important to its case to allege deficiencies not identified by the surveyors or cited as a basis for the imposition of a remedy, then CMS always has the option of withdrawing its proposed imposition of remedies, amending its notices to Petitioner, and restarting the clock for Petitioner to request a hearing. See 42 C.F.R. �� 498.30, 498.32, and 498.78. Furthermore, even if I were to consider the allegations, CMS has not shown that "with assist" and "with lift" are not synonymous as used in Petitioner's records.

7. CMS alleges in briefing before me that there were other instances when Petitioner's staff transferred Resident 10 by a two-person assist and did not use a lift. CMS Prehearing Brief at 20; CMS Brief at 11. However, the additional allegations by counsel for CMS were not cited as deficiencies by the state agency in the SOD at CMS Ex. 1. Thus, it is clear that those allegations were not the basis for the imposition of any remedy in this case. Nor can it be argued that Petitioner was notified of those allegations as contemplated by the regulations. See 42 C.F.R. � 488.330. If CMS determines that it is important to its case to allege deficiencies not identified by the surveyors or cited as a basis for the imposition of a remedy, then CMS always has the option of withdrawing its proposed imposition or remedies, amending its notices to Petitioner, and restarting the clock for Petitioner to request a hearing. See 42 C.F.R. �� 498.30, 498.32, and 498.78. Further, considering the evidence cited by CMS in support of the additional allegations, I find that the language used in the documents cited is not sufficient to raise the inference upon which CMS seeks to rely.

8. According to the written statement by the N.E.A.T. bus driver, the driver had strapped Resident 20's wheelchair to the bus and put the lap belt on her, but did not use the shoulder strap because the resident is very small. CMS Ex. 20, at 39, 88.

9. While not mentioned in the SOD, Petitioner's staff noted in Resident 29's care plan that she is "at risk for injury from falls. She has had no falls in the last three months." P. Ex. 8, at 19.

10. Ms. Hutchings testified that Petitioner had had a system whereby it would send residents on its own facility van, which was equipped to transfer wheelchair-bound residents, but Petitioner let the van driver go, and instead switched to the N.E.A.T. bus service to transport residents. Ms. Hutchings was told that the reason for the switch was that Petitioner "did not want to pay for a CMA [sic] to assist and go with residents." Tr. 296.

11. I recognize that this is hearsay; however, Petitioner has never disputed that family and physicians expressed concern about its practice.

12. Ms. Stewart testified that catheter care also involved wiping and cleaning the tubing. Tr. 459.

13. Ms. Stewart also testified that there was a fire drill, and staff "just shut the door and continued on to the next room." Tr. 402.

14. The SOD states that the care plan is dated "9/6/02." CMS Ex. 1, at 29. The date on the care plan in evidence is actually "09/06/2001."

15. CMS Ex. 17, at 58 is a MAR that lists "MS contin" in the "medications" column, and, according to the dates at the bottom, covers the period from November 1, 2002 through November 30, 2002. Along the top of the document is one row of dates and below this row, the corresponding days of the month. On this particular document, however, the days of the month have been changed via someone's handwriting for the 24 ^th through the end of the month. At the hearing, I questioned Ms. Rushing as to her interpretation of these changes, and she conceded that it was possible that the changes were meant to indicate October 2002 dates. Tr. 380-82.

16. Ms. Rushing also testified that she found that on one occasion Petitioner had not administered Demarol as ordered and that was of concern to her. Tr. 356. However, that is not alleged as a deficient practice in the SOD. CMS Ex. 1, at 29-32.

17. According to the scope and severity matrix published in the SOM, section 7400E, a scope and severity level of D, E, or F indicates a deficiency that presents no actual harm but has the potential for more than minimal harm that does not amount to immediate jeopardy. A scope and severity level of G, H, or I indicates a deficiency that involves actual harm that does not amount to immediate jeopardy. The matrix, which is based on 42 C.F.R. � 488.408, specifies which remedies are required and optional at each level based upon the frequency of the deficiency. See SOM, section 7400E.