SUBJECT:

Lakeridge Villa Health Care Center,

Petitioner,

Centers for Medicare & Medicaid Services.

DECISION

I conclude that Lakeridge Villa Health Care Center (Petitioner or facility) was not in substantial compliance with Medicare conditions of participation governing nursing home facilities at an immediate jeopardy level from August 23, 1999 through August 30, 1999, and at a non-immediate jeopardy level from August 31, 1999 through October 3, 1999. In so doing, I find that the assessment of immediate jeopardy was not clearly erroneous and that the civil money penalties (CMPs) assessed were for a reasonable amount. Accordingly, I sustain the determination of the Centers for Medicare & Medicaid Services (CMS) to impose CMPs of $80,300 on Petitioner.

I. FACTUAL AND PROCEDURAL BACKGROUND

Petitioner is a skilled long-term nursing facility located in Cincinnati, Ohio. On August 27, 1999, the Ohio Department of Health (State agency) conducted a complaint and standard survey at Petitioner's facility. The State agency cited Petitioner for numerous alleged deficiencies, one of which was categorized as immediate jeopardy. On October 8, 1999, CMS notified Petitioner that it concurred with the State agency's findings and would impose CMPs in the amount of $5,150 per day effective August 23, 1999 through August 30, 1999, and in the amount of $1,150 per day effective August 31, 1999 until Petitioner achieved substantial compliance. CMS also imposed the remedies of directed in-service training on the subject of proper applications of physical restraints and assistance devices, a denial of payment for new admissions effective October 30, 1999, and the proposed termination of Petitioner's Medicare provider agreement on January 30, 2000, if Petitioner had not attained substantial compliance by that date. On December 1, 1999, CMS notified Petitioner that a resurvey by the State agency on October 8, 1999, found that Petitioner was in substantial compliance with participation requirements as of October 3, 1999. CMS accordingly rescinded the following remedies: directed in-service training, denial of payment for new admissions, and termination of Petitioner's Medicare provider agreement. In that letter, CMS also stated that the per day CMP of $1,150 ended on October 3, 1999, resulting in the total amount of CMPs imposed of $80,300. Petitioner timely requested a hearing by letter of December 7, 1999.

The case was assigned to several Administrative Law Judges (ALJ) before the case was assigned to me. I held a hearing in Cincinnati, Ohio, from May 13 - 15, 2003. I admitted the following CMS exhibits (CMS Exs.) into the record: 1 - 32 (including 7A), 75 - 93. I admitted the following Petitioner exhibits (P. Exs.) into the record: 1 - 3, 5, 7, 9 - 12, 15, 20 - 24, 26, 28, 29, 31 - 33, 35 - 44, 46, and 47. ⁽¹⁾ The following individuals testified for CMS at the hearing: State agency surveyors Debbie Truett, R.N.; Bernadette Poole, R.N.; Mary Pat Stahl, licensed and registered dietician; and Leatha Ann Slusher-Rose, R.N. Petitioner offered the testimony of one witness, Pamela Ruth Griffin, a licensed practical nurse (LPN) employed by Petitioner. After receiving a copy of the hearing transcript (Tr.), both parties submitted briefs (Br.) and reply briefs (R. Br.).

II. REGULATORY AND LEGAL BACKGROUND

Petitioner is considered a long-term care facility under the Social Security Act (Act) and regulations promulgated by the Secretary of Health and Human Services (Secretary). The statutory and regulatory requirements for participation by a long-term care facility are found at sections 1819 and 1919 of the Act and at 42 C.F.R. Part 483.

Sections 1819 and 1919 of the Act invest the Secretary with authority to impose CMPs against a long-term care facility for failure to comply substantially with federal participation requirements.

Pursuant to the Act, the Secretary has delegated to CMS and the states the authority to impose remedies against a long-term care facility that is not complying substantially with federal participation requirements. Part 488 of 42 C.F.R. provides that 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. The regulations contain special survey conditions for long-term care facilities. 42 C.F.R. �� 488.300-488.335. Under Part 488, a state or 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 give CMS a number of different remedies that can be imposed if the facility is not in compliance with Medicare requirements. Id.

The regulations specify that a per day CMP that is imposed against a facility will fall into one of two broad ranges of penalties. 42 C.F.R. �� 488.408; 488.438. The upper range of CMPs, of from $3,050 per day to $10,000 per day, is reserved for deficiencies that constitute immediate jeopardy to a facility's residents, and, in some circumstances, for repeated deficiencies. 42 C.F.R. �� 488.438(a)(1), (d)(2). "Immediate jeopardy" is defined as "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." 42 C.F.R. � 488.301. The lower range of CMPs, of from $50 per day to $3,000 per day, is reserved for deficiencies that do not constitute immediate jeopardy, but either cause actual harm to residents, or cause no actual harm, but have the potential for causing more than minimal harm. 42 C.F.R. � 488.438(a)(2).

The regulations define the term "substantial compliance" to mean "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." 42 C.F.R. � 488.301.

When a penalty is imposed and appealed, CMS must make a prima facie case that the facility has failed to comply substantially with federal participation requirements. To prevail, a long-term care facility must overcome CMS's showing by a preponderance of the evidence. Hillman Rehabilitation Center, DAB No. 1611 (1997); aff'd, Hillman Rehabilitation Center v. U.S., No. 98-3789 (GEB) (D.N.J. May 13, 1999). Batavia Nursing and Convelescent Inn, DAB No. 1911 (2004). Under Hillman and Batavia, CMS bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner failed to comply with participation requirements. Once CMS has established a prima facie case of noncompliance, Petitioner has the burden of proving, by a preponderance of the evidence, that it complied substantially with participation requirements. Hillman Rehabilitation Center, DAB No. 1611.

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)(12), (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).

III. ISSUES

The issues in this case are whether CMS has a factual basis to impose CMPs against Petitioner for failing to comply substantially with Medicare participation requirements. If so, the next question is whether CMS's determination that the deficiencies put Petitioner's residents in immediate jeopardy is clearly erroneous. The final issue, if the CMPs are authorized, is whether the amounts imposed are reasonable.

IV. FINDINGS OF FACT AND CONCLUSIONS OF LAW

I have examined closely all of the evidence of record to determine whether Petitioner was complying with participation requirements and to decide whether a CMP may be imposed against Petitioner. Although Petitioner was cited in the August 1999 survey for having failed to meet numerous requirements for participation in the Medicare program, CMS elected to present evidence at the hearing for only six of the deficiencies. ⁽²⁾ These deficiencies were identified as " Tags" and refer to particular regulatory requirements as follows:

1. F 324 - Quality of Care 42 C.F.R. � 483.25(h)(2)

2. F 221 - Resident Behavior and Facility Practices 42 C.F.R. � 483.13(a)

3. F 309 - Quality of Care 42 C.F.R. � 483.25

4. F 314 - Quality of Care 42 C.F.R. � 483.25(c)

5. F 316 - Quality of Care 42 C.F.R. � 483.25(d)(2)

6. F 272 - Resident Assessment 42 C.F.R. � 483.20(b)

CMS cited Tag F 324 at the immediate jeopardy level, with the other deficiencies not posing immediate jeopardy to the facility's residents.

The preponderance of evidence, as discussed below, supports the finding that Petitioner failed to comply with several conditions of participation. This is a sufficient basis to affirm CMS's imposition of a CMP against Petitioner.

I make findings of fact and conclusions of law (Findings) to support my decision in this case. I set forth each of my ultimate findings below as a separate heading. I discuss each finding in detail, including the results of the survey, whether the results are supported by the evidence of record, and whether Petitioner has met its burden to overcome the findings the surveyors made.

I discuss below all the alleged deficiencies brought against Petitioner by CMS at the hearing, beginning with the most serious allegation against Petitioner, the finding of immediate jeopardy arising from the deficiency at Tag F 324.

1. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25(h)(2).

Under the heading "Accidents," the regulations at 42 C.F.R. � 483.25(h)(2) require that a facility must ensure that each of its residents receives adequate supervision and assistance devices to prevent accidents. CMS alleges that Petitioner's application of restraints in contravention of manufacturer's recommendations and without adequate supervision caused Petitioner's residents to be in likely danger of serious injury or death. CMS assigned a finding of immediate jeopardy to Petitioner's failure to meet this participation requirement. Petitioner responds to CMS's allegations primarily with legal arguments and conclusions concerning why the circumstances I discuss below with respect to each resident do not constitute noncompliance. Petitioner made little attempt to offer evidence that would counter the factual circumstances the surveyors described.

I specifically note at the outset of discussion regarding Tag F 324 that Petitioner argues CMS's allegations under this tag should have been dismissed because CMS sent Petitioner a letter in May 2003 and included "Tag 323" rather than "Tag 324"as one of the tags it would pursue at the upcoming hearing in this case. "Tag 324" was not included in the list. The statement of deficiencies (SOD) in this case did not cite a "Tag 323." CMS's reference to "Tag 323" as opposed to "Tag 324" was clearly a typographical error both because the SOD contained no "Tag 323" and because CMS did not suggest it was dropping the tag for which it had assigned immediate jeopardy. If Petitioner was at all confused about CMS's intentions after the letter, Petitioner could have asked either CMS or my office. Petitioner did neither. I decline to dismiss this tag because of an obvious typographical error for which Petitioner has shown no prejudice. ⁽³⁾

a. Petitioner knew or should have known of the potential harm posed by incorrect use of restraints.

When a facility uses restraints with residents, essentially tying the resident into a position, the facility must ensure that the restraint is tied correctly. If it is not, the restrained resident can experience serious injury. For example, if a restraint is tied to the non-moveable part of the bed frame and the head of the bed is lowered or raised, the resident can suffer chest compression or suffocation. CMS Ex. 79. Also, the resident may be injured by catching limbs in siderails and/or by attempting to change position with the restraint on. Id. Additionally, extra supervision or assistance devices such as bed alarms are required for residents who are restrained. ⁽⁴⁾ See Id.

The manufacturer of the restraints used by Petitioner, the Posey restraint, includes in its product information instructions that the restraint straps be tied to the moveable part of the bed frame so that the device will not tighten or loosen when the bed is raised or lowered. Tr. 22, 36 - 38; CMS Ex. 79, at 6. Other instructions in the manufacturer's safety bulletin include: monitoring patients frequently because, if a resident slides down or becomes suspended by the restraint, chest compression and suffocation could result. Id. The instruction folder contains the following explicit instruction:

Siderails must be in the UP position when using restraints in bed. Do not use any siderail that will allow the patient's body or limbs to fit over, under, around, through, or between siderails and become suspended in the restraint, resulting in chest compression and suffocation.

CMS Ex. 79, at 6.

Under large and bold type stating "warning," the manufacturer states:

1. Always monitor patients frequently!

2. Restrictive products should be used only after all other non-restrictive interventions are been considered.

3. The inappropriate and/or incorrect application of restrictive products may result in serious injury or death.

CMS Ex. 79, at 2.

b. With respect to six residents, Petitioner failed to rebut CMS's prima facie case that the residents did not receive adequate supervision and assistance devices to prevent accidents.

The surveyors recorded several different instances when Resident 30 was observed with a waist restraint that was used contrary to the manufacturer's instructions. Tr. 22; CMS Ex. 79. First, Resident 30 was seen with a waist restraint tied to the non-movable part of the bed frame. Tr. 35 -38. The waist restraint was tied too tightly and the resident complained. Id. The resident did not have a bed alarm on the bed even though there was a physician's order for a bed alarm. Tr. 35 - 36. At another time, Resident 30 was observed trying to get out of bed and had scooted her legs towards the edge of the bed with the waist restraint around her chest. No facility staff members were around to supervise Resident 30. Tr. 38 -39.

At another time, a surveyor observed Resident 30 in bed with a waist restraint on and the siderail down for the serving of a meal. The resident was leaning toward the side of the bed and no facility staff members were supervising the resident and no bed alarm was in place. Tr. 42 - 43. On still another day, Resident 30 was observed in her bed with a waist restraint on with the right siderail down and without a bed alarm. Tr. 43 - 44. On another day, Resident 30 was observed in bed with a restraint on, a meal tray on the bedside table, no bed alarm and no supervision. Tr. 44 - 45.

Resident 29 had diagnoses including arthritis, Parkinson's disease, Alzheimer's disease and a past hip fracture and required extensive assistance for transfers and ambulation. Resident 29 was dependent on staff for all other care. Tr. 51 -52. She had a soft waist restraint ordered for her. Tr. 50 - 51. On August 21, 1999, a surveyor saw the resident seated in a wheelchair with a waist restraint on for over four hours without supervision, first in the dining room and then in her bedroom. The resident was observed leaning in her wheelchair and trying to scoot forward. Tr. 61 - 63. The next day, the surveyor saw the resident in bed, equipped with three-quarter length siderails, with a waist restraint on that was tied inappropriately to the non-moveable part of the bed frame and the waist restraint was across the resident's chest and breast. The resident was pulling at the restraint, attempting to pull the restraint over her head. The resident was not supervised. Tr. 63 - 65.

On August 24, 1999, Resident 29 was observed in bed with a waist restraint. She was turned on her right side and the siderail on the left side was down. Tr. 67 - 68. A staff member said the rail had detached. Id. On August 25, 1999, the resident was observed in bed with the waist restraint tied to the non-movable part of the bed frame. The bed had a bed alarm but it was not attached to the resident. The resident was not being supervised. Tr. 68 - 69.

Resident 22 had impaired short and long-term memory and severely impaired decision-making ability. Tr. 237. Her physician had ordered a soft waist restraint for her while she was in bed and in a chair. Tr. 237 - 38. She was at high risk for falls because of her attempts at unassisted ambulation while in the chair and her inability to use a call light. Id.; CMS Ex. 10, at 6. On August 18, 1999, she was found on the floor next to her bed, and her restraint had pulled loose from the right side of the bed. Tr. 238. On August 21, 1999, the resident was observed attempting to get out of bed by coming out of the bottom area of the bed with the three-quarter siderails raised. Her waist restraint had been tied to the non-moveable part of the bed and the restraint was up around her breasts. A staff member came to the room to assist the resident back to bed. Tr. 239 - 40.

On August 24, 1999, a surveyor observed Resident 22's waist restraint again tied to the non-movable part of the bed frame. Resident 22 had been thrashing in bed and had red abrasions on her rib cage from the rubbing of the restraint on her body. Tr. 241 - 42. The surveyor informed a facility nurse that Restraint 22's restraint was improperly tied. Tr. 241 - 42. On August 25, 1999, Resident 22 was observed in bed with the waist restraint on. Resident 22 had a bed alarm but the alarm was ineffective as it was not connected to the resident. Tr. 242 - 43. On August 27, 1999, the resident was observed in bed but the bed alarm was turned off. Later, Resident 22 was observed thrashing about and there were no staff members around to supervise her. Tr. 74.

As a result of Huntington's disease, this resident, who was only 33 years old (CMS Ex. 21, at 1), had uncontrollable, aggressive jerking movements of the body and extremities. He was able to make large motor movements, but did not have enough control of his muscles to place himself intentionally into a body position. Tr. 87, 439 - 40. He was fed through a gastrostomy tube. CMS Ex. 21, at 2. He had a physician's order for a vest restraint while in bed and when up in a chair for safety and protection due to his unsteady gait and prior falls. Tr. 440. On August 24, 1999, a surveyor observed him in bed tossing and turning with a vest restraint on. Tr. 440 - 41. He was moving quickly and spastically. He was swinging around and pushing the pads on his siderails through the rails. His movements had pushed his sheets and pillowcase cover off of his bed. Id. Resident 74 had pushed the siderail pads through the siderails, creating a six inch gap between the siderails and the mattress. Tr. 441. Staff members walked by his room without coming to his assistance. A nurse aide finally came into the room and covered the resident, repositioned him and placed the siderail pads back into proper position. Tr. 442. About 20 minutes later, a surveyor saw Resident 74 again making uncontrollable movements and he had pulled his tube feeding pole over onto the siderails of his bed. The tube feeding pump was infusing into the resident's gastrostomy tube at that time. The surveyor notified Petitioner's staff. Tr. 443 - 44. About 20 minutes later, nursing staff assisted the resident into a geri-chair and into his vest restraint. Resident 74's vest restraint was too large for his frame. Tr. 530 - 31.

About one hour later, Resident 74 was alone in his bedroom and he had scooted off his geri-chair and was fully suspended in his vest restraint. The restraint was up around his neck and high underneath his arms. Tr. 444 - 46, 538 - 39. There were no facility staff members in the unit to help this resident. The surveyor commandeered two nursing assistants from another unit to lift Resident 74 back into the chair. Tr. 446, 542. The staff members then turned off the light and left Resident 74 alone in the room. They did not adjust the restraint. Tr. 541 - 42. Less than 20 minutes later, Resident 74 was observed again off the chair and suspended by the vest restraint. Tr. 89, 543 - 44. After some effort, two nurses were found who were able to get the resident out of the suspended position and into a reclining geri-chair. Finally, the staff replaced Resident 74's vest restraint with one that was sized appropriately for his body. Tr. 545 - 47; CMS Ex. 21, at 9; CMS Ex. 79, at 5.

In addition to being too large, Resident 74's vest restraint was likely contraindicated due to his agitation and restlessness. Tr. 550 - 52, 557 - 58. Moreover, Resident 74's first vest restraint was improperly tied around the arms of the geri-chair and secured at waist level behind the resident. According to manufacturer's instructions, the restraint straps should be pulled at a 45 degree angle across the hips and then tied down underneath the chair out of the reach of the patient. Tr. 534 - 35; CMS Ex. 79, at 3. Again on August 26, 1999, a surveyor observed that the resident's vest restraint while in bed was tied too tightly at his shoulder level. Tr. 554 - 55.

On August 28, 1999, Resident 74, while thrashing in bed, flipped himself over from his stomach to his back. His G-tube was infusing at the time and the tube feeding pole was being pulled across the floor by the resident's thrashing. No staff was supervising the resident. Tr. 556 - 57; CMS Ex. 21, at 18. On August 29, 1999, Resident 74 was in a darkened bedroom, seated in a geri-chair, with his vest restraint raised up to his chest level. Tr. 93 - 94; CMS Ex. 28, at 14.

On August 24, 1999, Resident 73 was observed in bed with a pelvic restraint applied. A pelvic restraint looks like an adult diaper that is placed between the user's legs and then secures the user to either a bed or chair. Tr. 454 - 55. Resident 73 was lying on a bare mattress. Tr. 76. She was pulling herself upwards trying to get out of bed and her legs were off the side of the bed. Tr. 77. Resident 73's room door was closed and no staff were in the immediate area. Id. On August 26, 1999, Resident 73 was observed in bed with her pelvic restraint on. She started calling out. Tr. 470 - 71. Two nurse aides walked by the room but offered no assistance. Resident 73 began talking loudly and calling out. Again two facility staff members walked by and offered no assistance. Id. About 10 minutes later, Resident 73 was sitting up in bed and reaching over trying to untie her restraint (in the past, she had been able to untie the restraints). Tr. 472 - 75. After being requested to do so, a staff member was found who entered Resident 73's room, closed the door and quickly left, leaving the resident unsupervised. Id. Resident 73's assigned nurse was, according to this staff person, giving another resident a bath and was unable to assist Resident 73 at that time. The first nurse repositioned the resident before leaving the room. Id.

Resident 73 became increasingly agitated as the morning progressed. While alone in her room, restrained by a pelvic restraint, she began pulling on her adult diapers and ripping and shredding them. Tr. 472 - 75. She sat up in bed, cried, pulled on her restraint ties and shredded her diapers. She began rocking back and forth and calling out. Her assigned nurse walked by but did not offer the resident any assistance. Id. Resident 73 reached for her restraint straps and yelled, "I'll be good. Please help me. I can't get up. I can't get up." Resident 73 threw her legs over the siderail. Finally, about 45 minutes after she started crying out, Resident 73's nurse came in and assisted her into the bathroom. Id.

On August 29, 1999, Resident 73 was alone in her bedroom wearing a pelvic restraint. She was awake and agitated. Although Resident 73 had a bed alarm attached to her, the alarm works were tucked between two pillows, rendering it ineffective in alerting staff if she tried to climb out of bed. Resident 73 was raising herself, scooting over to the edge of the bed, actively trying to get out. Her actions caused a three to four inch gap between the mattress and siderail, and the resident's legs and feet were in the gap. Tr. 81 - 84.

Petitioner argues that Resident 73 routinely refused to remain in bed and was very combative and aggressive and that CMS complains only because this resident did not receive "instant gratification" for her requests for attention. P. Br. at 17, 22. This resident, according to Petitioner, engaged in attention seeking behaviors, was on psychotropic medications and was described as psychotic. She yelled and talked a lot, and the reliability of her communication was suspect. P. Br. at 18. While Petitioner's description of Resident 73 may be accurate, her difficult conduct does not absolve Petitioner from its responsibility to use restraints correctly so as to minimize the potential for harm.

c. Pursuant to regulations, as written and interpreted by the Departmental Appeals Board (Board), Petitioner failed to take reasonable measures to prevent foreseeable accidents.

Petitioner argues that CMS is imposing strict liability with respect to 42 C.F.R. � 483.25(h)(2). Petitioner's argument is inapplicable herein. The standard to be considered in accident cases is generally expressed as a statement that the regulations do not require a facility to be free of all accidents; strict liability is not assigned to a facility for accidents a resident may sustain. In cases, however, concerning a facility's compliance with 42 C.F.R. � 483.25(h), the focus is on the affirmative duty of the facility to ensure that each resident receives adequate supervision to prevent accidents. While a facility is not required to do the impossible or be a guarantor against unforeseeable occurrences, the facility is required to do everything in its power to prevent accidents. Stated in a slightly different way, the facility is obligated to take measures that are designed, to the extent that is practicable, to ensure that residents do not sustain accidents that are reasonably foreseeable. See Koester Pavilion, DAB No. 1750 (2000); Woodstock Care Center, DAB No. 1726 (2000), aff'd, 2003 WL22718244 (6^th Cir.).

CMS's argument herein is that accidents are reasonably foreseeable when a facility incorrectly uses restraints and provides inadequate supervision for residents with restraints. My decision with respect to this tag is based on CMS's factual showing that accidents were reasonably foreseeable with restraints being used as Petitioner was using them and that Petitioner failed to take reasonable and practicable measures to assure that accidents did not occur to the residents wearing restraints.

I conclude that the evidence presented by CMS shows that accidents were reasonably foreseeable in the circumstances as described above for Residents 30, 29, 8, 22, 74 and 73. The restraint manufacturer provided product instructions telling the users that serious complications of chest compression can result from tying restraints to the non-movable part of a bedframe and using them with siderails not in position. CMS Ex. 79. The surveyors actually observed numerous instances when Petitioner's staff had tied restraints to the non-moveable part of residents' bedframes and had left residents in bed with restraints and the siderails of their bed in the down position.

Rather than submitting evidence in response to CMS Ex. 79, Petitioner argues that CMS failed to prove that Petitioner's staff engaged in the practice of raising or lowering a bed with a restraint tied to an non-movable part of the bed frame. ⁽⁵⁾ Petitioner's argument misses the mark. What CMS has shown and what Petitioner failed to rebut is that additional supervision is required for residents wearing restraints, again as instructed by the restraint manufacturer. Id. The facility failed to monitor residents in restraints who had siderails down and attempted to leave the bed, pulling on the restraint, and posing the clear and known risk of chest compression and strangulation. Id.; Tr. 67. For example, Resident 30 was left alone in bed with a waist restraint, a siderail left down, no bed alarm, and the resident was attempting to leave the bed. Tr. 43 - 44. Similarly, Resident 29 was left alone in her bed with a waist restraint tied to the non-moveable part of the bed frame, with the head of the bed raised, and was trying to pull the restraint over her head. Tr. 63 - 66. Also Resident 74 was placed in an ill-fitting vest restraint which left him hanging off the front of his geri-chair. Tr. 89 - 90, 444 - 46, 538 - 39.

d. The potential for more than minimal harm and, thus, Petitioner's substantial noncompliance, exists even though no actual injury occurred.

Petitioner also argues that an attempted accident is neither an accident nor a deficient practice. Petitioner presents substantial argument in its reply brief concerning application of strict liability in ALJ and Board decisions. P. R. Br. Petitioner speaks particularly about concepts of "foreseeability, possibility versus probability, definitions of duty." Id. at 11. I expressly find that Petitioner had a clearly stated duty under the regulations to provide adequate supervision to its residents wearing restraints because it was foreseeable that serious danger was probable with inappropriate application of restraints and leaving residents with restraints without adequate supervision. In fact, Petitioner was basically lucky that no one was hurt. The manufacturers of the restraints provided sufficient warnings that the residents were to be supervised when wearing the restraints. For the resident with Huntington's, the facility had ample warning that he was likely to get seriously hurt in the vest restraint he was wearing. Petitioner provided no evidence that staff was trained in the use of restraints or that staff was specifically trained not to raise the bedframe when the restraint was tied to a nonmovable part of the bed. Moreover, the Board has clearly interpreted the regulations as not requiring harm, but the potential for more than minimal harm, as determinative of noncompliance. Western Care Management Corp., d/b/a Rehab Specialties Inn, DAB No. 1921 (2004); Lake City Extended Care Center, DAB No. 1658, at 14 (1998).

e. CMS's assessment that Petitioner's noncompliance with 42 C.F.R. � 483.25(h)(2) presented immediate jeopardy to Petitioner's residents is not clearly erroneous.

Immediate jeopardy occurs when a 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. Given CMS's expertise in determining the scope and severity of a cited deficiency, I cannot change CMS's assignment of immediate jeopardy unless that assignment is clearly erroneous. I am constrained by 42 C.F.R. � 498.60(c)(2) which provides that the ALJ upholds "CMS's determination as to the level of noncompliance of an SNF or NF . . . unless it is clearly erroneous." See also 42 C.F.R. � 498.3(d)(10).

In this case, Petitioner's noncompliance with federal requirements did not cause injury, harm, impairment, or death to any of Petitioner's residents. Of course, a finding of immediate jeopardy does not require any finding of actual harm to justify a determination that immediate jeopardy exists, as the definition of "immediate jeopardy" indicates a showing of actual harm is not necessary. Fairfax Nursing Home, Inc., DAB No. 1794 (2001); Southridge Nursing and Rehabilitation Center, DAB No. 1778 (2001). The issue in this case is whether Petitioner's noncompliance was "likely" to cause injury, harm, impairment, or death. I must consider the probabilities of harm given the noncompliance. The determination of whether there was immediate jeopardy requires some prognosticating, some predicting of probabilities, as reasonable minds can and do differ on issues such as these. Southridge Nursing and Rehabilitation Center, DAB No. 1778.

I base my decision that CMS's assignment of immediate jeopardy in this case is not clearly erroneous on two factors. First, as noted above, the manufacturer's warnings about restraint application are expressed in strong, prominent and unambiguous language that patients wearing restraints must be monitored frequently; siderails must be in the up position when a restrained patient is in a bed; vest restraints must fit the size of the patient and the restraint must be tied to the immoveable part of the bed frame. CMS Ex. 79.

With respect to the vest restraint used on Resident 74, I note that the manufacturer's instructions warn that, "[t]hey are designed to be 'gentle reminders' and should not be used on aggressive, restless, agitated patients, to prevent sliding, or as upper torso supports." CMS Ex. 79, at 5. The instructions further note that, "[i]f there is a history of sliding down or danger that patient could become suspended in the restraint, resulting in chest compression and suffocation, the medical authority should be notified immediately so an acceptable alternative intervention or product can be used." Id. at 6; see Tr. 550 - 52. Moreover, the United States Food & Drug Administration issued a bulletin regarding potential hazards with protective restraint devices. The bulletin states that "[i]ncorrect use of these devices has involved using the wrong size for the patient's weight, errors in securing restraints, and inadequate patient monitoring. Such mistakes have resulted in fractures, burns and strangulations." CMS Ex. 79, at 7.

The second factor I considered in determining that CMS's assignment of immediate jeopardy was not clearly erroneous is that the surveyors determined immediate jeopardy not completely by a review of the records but by what they actually observed. All four of the surveyors who testified at the hearing are experienced surveyors and Surveyors Truett, Poole, and Slusher-Rose are all registered nurses. These surveyors could clearly see the danger to the residents posed by Petitioner's incorrect application of restraints and inadequate monitoring and testified as such. See, e.g., Tr. 37 - 40, 73, 88 - 90, 223, 231 - 34, 529 - 32. Their testimony, particularly with respect to Resident 74, reflected their distress at the way in which restraints had been used with him and the Petitioner's lack of supervision of Resident 74 when he was wearing the restraints. Therefore, I do not find their assessment of immediate jeopardy to be clearly erroneous.

2. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.13.

Section 483.13(a) of 42 C.F.R. provides that residents have the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms.

a. With respect to seven residents, Petitioner failed to rebut CMS's prima facie case that Petitioner used restraints on the residents without adequate medical justification.

Resident 30 was diagnosed with a seizure disorder, prior cerebral vascular accident (CVA or stroke), deep vein thrombosis (DVT) and osteopenia. CMS Ex. 8, at 1; CMS Ex. 3, at 5. She was unable to make realistic decisions about her own health and safety and was unable to understand she could not get up without assistance. Tr. 27 - 28; CMS Ex. 8, at 3. Resident 30 had a history of falls, especially from bed, and some falls resulted in head injuries. Tr. 23; CMS Ex. 8, at 17. On July 8, 1999, she suffered a hematoma to her forehead when she was found on the floor of her bedroom. Tr. 23 - 25; CMS Ex. 8, at 21. Resident 30 had a physician's order for a waist restraint to be used while she was in bed and in a chair to prevent falls and unassisted ambulation. Tr. 20; CMS Ex. 8, at 30, 38. Surveyor Truett testified that other less restrictive measures were available for Resident 30 that would have provided equal protection against falls. Tr. 34. For example, Resident 30 had a physician's order for a bed and chair alarm because she was unable to use a call light. CMS Ex. 8, at 38. During the time of the survey, however, the resident did not have a bed alarm or chair alarm attached to her person. Tr. 36.

Petitioner alleges that Resident 30's self-care deficits preventing ambulation due to an unsteady gait resulted in multiple falls. She had decreased muscular coordination, hypertension, seizure disorder, increased agitation, lower leg weakness, hyperactivity and was on anti-psychotic medications. Petitioner claims these are all medical symptoms justifying the use of restraints. P. Br. at 3 - 6. While these may be Resident 30's medical conditions and symptoms, which CMS does not dispute, Petitioner provided no expert testimony to support its assertions that these symptoms require or justify the use of restraints.

Surveyor Truett also testified that the use of a restraint with Resident 30 was actually unsafe because of her seizure disorder and posed a risk of injury if Resident 30 had a seizure with the restraint in place. Tr. 29 - 30.

Petitioner's witness, LPN Griffin, testified that a restraint was used for Resident 30 because "she was a danger to herself and could be a danger to others 'cause she stabbed me with a fork." Tr. 653. LPN Griffin described Resident 30 as confused, combative and aggressive. Tr. 655. She testified that other methods were used with Resident 30 such as changing her medications and moving her from floor to floor to reduce outside stimuli. Tr. 654. She did not explain in her testimony why Resident 30 had no bed or chair alarm. Nor did Petitioner provide any support for LPN Griffin's suggestion that restraints are appropriate for combative residents as a protection for the staff.

Resident 29 had diagnoses including arthritis, Parkinson's disease, anemia, heart disease, and hip fracture. CMS Ex. 9, at 1, 13. CMS concedes the facility appropriately ordered a soft waist restraint for this resident on January 4, 1999, after she had suffered the hip fracture. Tr. 51 - 52. An acute hip fracture often necessitates the use of a restraint for a resident who needs to be reminded not to get up while the fracture is healing. Tr. 51. Moreover, after her hip fracture, Resident 29 needed extensive assistance with ambulation. Tr. 52 - 53. But, after she fell out of bed on March 22, 1999, the facility correctly identified Resident 29 as a future candidate for restraint reduction. And, her medical records show that her hip fracture had healed by May 11, 1999. Tr. 53 - 54; CMS Ex. 9, at 13. Yet, Resident 29's waist restraint was still on and her restraint reduction plan had not been implemented even several months later at the time of the survey. Id. Surveyor Truett testified that Resident 29 did not have any medical symptoms at the time of the survey that justified the use of the restraint. Less restrictive alternatives were available, such as a low bed, scoop mattress, a mat on the floor beside the bed and a personal alarm device. Tr. 58 - 59.

As with Resident 30, Petitioner argues that Resident 29's medical symptoms and diagnoses supported the use of a restraint with her. LPN Griffin testified for Petitioner that Resident 29 had no idea of her safety needs and decreased cognition about her whereabouts and that justified the use of restraints. Tr. 656. Petitioner submitted no analysis done by the facility after Resident 29's hip had healed that concluded Resident 29 continued to need a restraint. Petitioner provided no expert testimony to support its conclusion that Resident 29's medical symptoms and diagnoses alone justified restraint use with her. Simply on the basis of their credentials, I find the registered nurses who testified for CMS to be more knowledgeable about justifications for restraint use than Petitioner's lone witness. Moreover, Surveyor Stahl, while not a registered nurse, is a licensed health care professional with a masters degree and many years of experience as a surveyor, and she provided credible testimony about the use of restraints. Tr. 467 - 68; CMS Ex. 92.

Petitioner admitted Resident 8 with diagnoses of dementia with psychotic symptoms, organic personality disorder, organic delusional disorder, diabetes and osteoarthritis. Tr. 218; CMS Ex. 11, at 1. CMS alleges Resident 8 had no medical symptoms justifying the use of a waist restraint, although she was seen several times during the survey with a waist restraint on. Tr. 223 - 24. The facility said it used the restraint to prevent her from climbing out of bed due to her inability to ambulate without assistance. Tr. 224 - 25; CMS Ex. 11, at 4. Less restrictive measures could have been used to ensure her safety such as lowering her bed, moving her closer to a nurses' station, moving her bed against the wall or employing a bed or pressure alarm. Tr. 226 - 28. Apparently, the soft restraint had been ordered by the physician as an "initial MD order," which came with the resident upon admission to Petitioner's facility in May 1999. Tr. 228 - 29. Nonetheless, Petitioner made no further assessments regarding restraint use with Resident 8 in the months between her admission in May and the survey in August 1999. Id.

Petitioner argues that Resident 8 had medical symptoms including restlessness, confusion, lack of awareness of surroundings related to psychotic symptoms with dementia, delusional disorder, osteoarthritis, and an unsteady gait, all of which justify restraint use. LPN Griffin testified that Resident 8 was agitated and the facility went through all sorts of devices with her but she was wild and wandering into other people's rooms. As a result, the facility requested a soft waist restraint from Resident 8's physician. Tr. 658. ⁽⁶⁾ LPN Griffin testified that the facility had tried a bed alarm but "a lot of those patients would just take the bed alarms off. They had chair alarms, you know that just plucked them off and threw them on the floor, whatever they wanted to do with them." Tr. 658 - 59. On the other hand, LPN Griffin's reference to Resident 8 as wild and wandering into other residents' rooms suggests to me that the restraint was used for staff convenience rather than Resident 8's safety. I find that Petitioner provided insufficient rebuttal evidence that Resident 8's condition and symptoms justified the use of restraints.

Resident 16 was diagnosed with senile dementia of Alzheimer's type, blindness in her left eye due to glaucoma, depression, arthritis, bipolar disease, hallucinations and agitation. Tr. 246; CMS Ex. 13, at 1. Resident 16 also experienced a loss of balance. P. Ex. 11, at 30. Her care plan indicated she was at high risk for falls due to her glaucoma, poor judgment, memory loss, cognitive loss and unsteady gait. Tr. 248, CMS Ex. 13, at 15. Ostsensibly due to her increased number of falls, a soft waist restraint was prescribed for Resident 16 only for when she was in bed, not when she was in a chair. Tr. 246 - 47; CMS Ex. 13, at 3. The surveyor testified she had seen Resident 16 wearing a waist restraint in bed on four occasions, and on three of those occasions the restraint was tied to the immoveable part of the bed frame. Tr. 247 - 48.

The State agency surveyor testified that Resident 16 did not have medical symptoms that necessitated the use of a soft waist restraint while she was in bed because, as shown by Petitioner's nurses' notes for August 5, 1999, Resident 16 was able to reposition herself in bed when she desired to do so. Tr. 250; CMS Ex. 13, at 4. The surveyor surmised the restraint was being used on Resident 16 for staff convenience because there were fewer of Petitioner's staff members available at night to supervise this resident and Resident 16 was more likely to get up from bed at night from anxiety rather than to leave her chair during the day. Tr. 250 - 51, 253. According to the surveyor, less restrictive measures were available to ensure Resident 16's safety, such as moving her to a room closer to the nurses' station, and putting an alarm on her to alert staff when she was getting out of bed. Tr. 252.

On the other hand, Resident 16's husband was adamant that Resident 16's waist restraint was necessary for her safety. CMS Ex. 13, at 57; Tr. 662 - 63. CMS alleges that the family's request for the use of a restraint is not a reason by itself for the facility to use a restraint in the absence of any medical symptoms necessitating the restraint. Tr. 255 - 56. According to CMS, the facility has the responsibility to educate the family on the problems that may result from the restraint and the ways in which less restrictive measures could be used to provide safety to the resident. Id. The Board has affirmed CMS's position on this issue. Cross Creek Health Care Center, DAB No. 1665 (1998). Moreover, a physician's prescription alone, without an interdisciplinary analysis, does not justify the use of a restraint. Tr. 31 - 33; CMS Ex. 80, at 3.

Petitioner submitted no evidence that the facility had considered less restrictive methods of assuring Resident 16's safety while she was in bed. Nor did Petitioner provide any evidence that substantiated that Resident 16's diagnoses and symptoms justified the use of a restraint. LPN Griffin only testified that the resident's husband insisted on the use of a restraint and threatened to sue the surveyors if the restraint was removed. Tr. 662 - 63.

Resident 73's diagnoses included Alzheimer's disease, congestive heart failure, coronary artery disease, a prior left knee replacement, hypertension, osteoarthritis and psychotic features. Tr. 457; CMS Ex. 14, at 1. She was unsteady while ambulating and totally dependent on staff for dressing, toileting and hygiene. She was able, however, to ambulate with a walker with the extensive assistance of one person. Tr. 457; CMS Ex. 14, at 3. Resident 73 was cognitively unable to use a call light. Id.

Petitioner assessed Resident 73 as needing a pelvic restraint while in a chair and in bed because, according to the facility, she was unsteady on her feet while ambulating alone and because she had periods of anxiety, was status post knee replacement and had Alzheimer's. Tr. 458 - 59; CMS Ex. 14, at 20. On August 26, 1999, Resident 73 was in bed restrained by the pelvic restraint, but she was calling out and was trying to untie her restraint. Tr. 456 - 57, 471; CMS Ex. 14, at 11 - 12.

CMS contends Resident 73 had no medical symptoms that required use of the restraint. Tr. 459. In particular, CMS alleges that Alzheimer's disease by itself is not a medical condition or symptom that justifies the use of a restraint. According to the testimony of the nurse surveyor, using restraints on Alzheimer's residents often increases their anxiety and agitation, causing them to attempt to get out of the restraints and injure themselves in the process. Id. Moreover, using a restraint with an Alzheimer's patient with an unsteady gait allows the resident to decline in ambulation ability. Tr. 460 - 61. Less restrictive methods could have been used such as a lowered bed, a scoop mattress, a mat on the floor, a sensor alarm under the mattress or a personal alarm attached to the resident, a chair alarm, or a pommel cushion on the chair. Tr. 461 - 63. Although this resident's power of attorney requested the use of the restraint at night and for the wheelchair, the family's desires cannot be the deciding factor. Neither the doctor's order nor the request of the patient's legal representative are by themselves determining factors for the use of a restraint. Tr. 464 - 68.

Petitioner claims that this resident was unsteady while ambulating due to agitation, right knee replacement and Alzheimer's disease. According to Petitioner, these factors justify the use of restraints. Id.; Tr. 665. LPN Griffin testified that Resident 43 was an Alzheimer's resident who was at a high risk for falls and her three sons insisted on use of the pelvic restraint. LPN Griffin said the facility had tried other things such as a lap buddy and a bed alarm, but Resident 73 was very heavy. Tr. 663 - 64. LPN Griffin provided no explanation as to how Resident 73's obesity affected use of less restrictive methods, such as a lap buddy or bed alarm.

I find that once the State agency surveyors proffered credible testimony that restraints were not required for this resident, Petitioner, to prevail, needed to submit a proponderance of evidence that the symptoms mandated restraint use. Petitioner did not.

Resident 60 had diagnoses including dementia with agitation, hypthyroidism and venous stasis. Tr. 560; CMS Ex. 15, at 1. The facility assessed this resident on June 30, 1999, as not needing any restraints because she was able to ambulate on the unit with supervision. Tr. 560 - 61; CMS Ex. 15, at 3. She was not assessed as a high risk for falls. Tr. 563 - 64; CMS Ex. 15, at 3.

On August 12, 1999, the facility sought and received a telephone order for a soft waist restraint after the resident fell the prior evening and injured her forehead. Tr. 562; CMS Ex. 15, at 4. The facility staff found this resident on the floor of another resident's room where she had wandered wearing her roommate's shoes that were too large for her. Tr. 562 - 63; CMS Ex. 15, at 4. CMS alleges the fact that this resident had dementia and agitation did not justify the use of a waist restraint. Less restrictive measures should have been implemented, such as a bed alarm or personal alarm clipped to her. Or, CMS contends, the facility could have toileted her more frequently at night, moved her closer to the nurses' station, and ensured her roommate's shoes were put away and her own were available to her. Tr. 565 - 66.

Petitioner argues that this resident's disorientation, confusion, dementia, psychosis and antipsychotic medications, and wandering with no purpose, justify the use of restraints. LPN Griffin testified that Resident 60 was easily agitated and combative. She fell and fractured her leg and fell again after it had healed and refractured it. Tr. 665. Thus, according to LPN Griffin, her doctor agreed to order a soft restraint for her. Id.

I find CMS's witnesses' testimony to be more persuasive than LPN Griffin's because of the surveyors' credentials and experience and because LPN Griffin again suggested that a resident's agitation and combativeness support the use of restraints. To use restraints because a resident is agitated or combative indicates the restraints were for the staff's convenience rather than the resident's safety.

Resident 62 had diagnoses including organic brain syndrome, seizure disorder and osteoporosis. Tr. 567; CMS Ex. 16, at 1. A pelvic restraint was ordered for Resident 62 to be used at all times in bed and in a chair. Tr. 567 - 68. The facility first ordered the restraint for Resident 62 almost two years prior to the survey. Id.; CMS Ex. 16, at 11.

Resident 62, according to CMS, had no valid medical symptoms requiring the use of the restraint. Less restrictive methods could have been used to ensure the resident's safety, such as more frequent monitoring, a pressure sensitive or personal alarm, a lap buddy for her chair, more frequent toileting, or moving the resident closer to the nurses' station. Tr. 569 - 70. Additionally, CMS contends that the resident was seated in her chair with a soft pelvic restraint and the staff wheeled her back to her room after breakfast and locked the brakes on her wheelchair and left her alone in her room. This resident remained alone in her bedroom with her wheelchair brakes locked for over three hours. Tr. 570 - 74; CMS Ex. 16, at 5. Resident 62 was unable to unlock the brakes on her wheelchair, but if the brakes were unlocked, the resident was able to move her wheelchair around the facility. Id. CMS alleges the locked wheelchair brakes were an additional restraint for which there was no medical reason and that, instead, the brakes were engaged on Resident 62's wheelchair for the staff's convenience. Tr. 570 - 74, 637 - 78; CMS Ex. 16, at 5.

LPN Griffin testified for Petitioner that Resident 62 was combative and agitated and had an unsafe gait. She had previously fractured her arm and the facility did not wish to risk more serious injury. LPN Griffin testified that other interventions had been tried such as bed alarms, padded siderails, ambulating with her, and medication reviews. Tr. 666 - 67. However, I find that LPN Griffin's reference to Resident 62's combativeness and agitation suggest the restraint was used for staff convenience rather than resident safety. Petitioner did not address Resident 62 and this tag in its posthearing brief.

With respect to the seven residents described above, Petitioner failed to ensure that the residents were only restrained when required for medical symptoms. CMS Ex. 3, at 5. A facility's decision to implement a restraint must be based on an assessment by an interdisciplinary team. And, while a physician's order may be persuasive evidence that a restraint is necessary, a facility cannot rely solely on a physician's order to prove compliance but must show with other evidence that the facility analyzed whether the restraints were necessary to treat the resident's symptoms and that they were not imposed for discipline or convenience. CMS Ex. 80, at 3; Cross Creek Health Care Center, DAB No. 1665.

Petitioner argues that the regulations do not specifically require that a facility's medical records contain a statement of symptoms justifying restraints. The regulations may not expressly state that a facility's records contain a statement justifying restraints, but the facility should be able to provide affirmative evidence that a thoughtful interdisciplinary assessment of restraint use for a resident was done prior to calling the resident's physician to request an order for a restraint. Petitioner also contends that diagnoses such as dementia, movement disorders, disorientation, and confusion all raise safety concerns that justify the use of restraints, but Petitioner provided no witness with the same or greater credentials as the surveyors to say the restraints were required for the residents at issue herein. I note that CMS does not dispute the diagnoses and/or symptoms for each of these residents that were proffered by Petitioner. The problem is that Petitioner did not present any evidence that it had analyzed whether less restrictive methods could have been used with these residents nor any evidence from a medical expert that the restraints were required to treat the residents' symptoms.

b. Use of restraints without medical justification presents the potential for more than minimal harm.

As discussed above, a restraint can cause physical injury and should not be used unless other less restrictive methods have been considered because of the physical problems inherent in their use. CMS Exs. 79, 80. Restrained individuals in long-term care facilities also experience the mental anguish of, among other things, fear, humiliation or demoralization. CMS Ex. 84; see CMS Ex. 80. I find, therefore, that the use of restraints that are not required by a medical condition, and as described above, presents the potential for more than minimal harm.

3. CMS failed to make a prima facie case that Petitioner was not in substantial compliance with 42 C.F.R. � 483.20.

According to the regulations, a facility must make a comprehensive assessment of each resident. The facility must make a comprehensive assessment of a resident's needs, using an assessment instrument specified by the state. 42 C.F.R. � 483.20(b). The assessment must include, inter alia, nutritional status and physical structural problems. 42 C.F.R. � 483.20(b)(1)(viii) and (xi).

a. With respect to the one resident at issue, CMS did not make a prima facie case that Petitioner had not done a comprehensive assessment as required by 42 C.F.R. � 483.20(b)(1)(viii) and (xi).

CMS contends the facility failed to make a comprehensive assessment of this resident's nutritional needs or safety needs with respect to restraints. Tr. 449 - 53; CMS Ex. 21, at 3 - 4. I find that Petitioner may not have adequately "care planned" for Resident 74's nutritional or safety needs, but I do not find that equates with the regulatory requirement to do a comprehensive assessment. CMS showed that on July 13, 1999, the facility reduced the infusion rate on this resident's gastrostomy tube from 90 cc per hour to 65 cc per hour. At the time of the subject survey, the infusion rate for this resident continued to be 65 cc per hour. Id. The facility's dietary note of August 21, 1999, however, recommended that the 90 cc per hour infusion continue for the resident without any mention of the lower 65 cc infusion rate previously implemented. Id. According to CMS, Petitioner failed to comprehensively assess and evaluate whether Resident 74's needs for calories, protein and fluids were being met as a result of the decreased infusion rate. Id. Insufficient calories can cause weight loss, insufficient protein can result in skin breakdown, and insufficient fluids can cause possible constipation and fecal impaction. Id.

CMS also alleges that the facility failed to address and assess the resident's safety when using a vest restraint given the facility's knowledge of this resident's ability to get out of the vest restraint and tendency to try to get up with the restraint on. Tr. 452 - 53; CMS Ex. 21, at 33. Moreover, based on the manufacturer's instructions, the vest restraint was contraindicated because of the resident's constant involuntary movements and frequent suspension by the restraint while in a chair. Tr. 452 - 53, 550 - 51.

LPN Griffin testified that the lessening in infusion for Resident 74 was because the dietician was trying to decrease this resident's frequent loose stools by reducing his liquid intake. The temporary reduction of infusion rate was successful in decreasing the number of loose stools. Resident 74's intake was then increased back to the usual rate. According to LPN Griffin, Resident 74 stayed within his ideal body weight throughout this process. Tr. 670 - 71. She also testified that the facility tried Resident 74 with a low bed but, because he was fed by a gastrostomy tube, the head of the bed needed to be at a 45 degree angle and low beds do not provide that degree of adjustment. Id. ⁽⁷⁾

Petitioner argues that the assessments referred to in the regulations at 42 C.F.R. � 483.20(b) do not require a facility to address safety issues versus risk factors for purposes of restraint use. Of course, the regulations do not, and cannot, address every situation in a nursing home. Using a restraint and cutting calories certainly are points of care that require some analysis on the part of the staff. However, I agree with Petitioner that with respect to this cited deficiency the regulations do not require a comprehensive assessment in the absence of a significant change in a resident's condition. The regulations set forth with particularity when a facility must make a comprehensive assessment of a resident; that is, within 14 calendar days after admission (section 483.20(b)(2)(i)); within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition (section 483.20(b)(2)(ii)); or, not less than once every 12 months (section 483.20(b)(2)(iii)). CMS made no showing that Petitioner failed to comprehensively

assess Resident 74 at his admission or annually. Nor did CMS make any showing that there were significant changes in Resident 74's condition that required a new comprehensive assessment under section 483.20(b)(2)(ii). While I might find that Petitioner failed to provide some necessary services to Resident 74 with regard to his nutrition and the application of a vest restraint, I cannot determine, based on the evidence submitted by CMS, that Petitioner failed to appropriately assess Resident 74 under Tag F 272.

4. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25.

The regulations for Medicare participation at 42 C.F.R. � 483.25 require 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.

a. With respect to seven residents, Petitioner failed to rebut CMS's prima facie case that it did not provide the necessary care and services so that the residents could attain or maintain their highest practicable physical, mental and psychosocial well-being, in accordance with their comprehensive assessment and plan of care.

Resident 39 was 75 years old and had diagnoses including ataxia, cerebral vascular accident, diabetes, hypertension, status post subdural hematoma, multiple falls and dysphagia. Tr. 98; CMS Ex. 3, at 37; CMS Ex. 17, at 1. This resident attempted to climb out of her bed on both June 4, 1999 and July 2, 1999. CMS Ex. 3, at 37 - 38; CMS Ex. 17, at 4. On July 5, 1999, the staff found this resident sitting on her bedroom floor. Id. Again, three weeks later on July 24, 1999, the staff found her sitting on the floor. Id. The facility made no changes to this resident's care plan as a result of these incidents. CMS Ex. 3, at 38; CMS Ex. 17, at 13. On four separate occasions, March 2, March 23, June 8, and July 24, 1999, the facility assessed this resident as a high risk for falls. Tr. 98; CMS Ex 17, at 7 - 8. Although the facility's care plan for this resident identified interventions to prevent her falls, such as incontinence care, giving her a call light within reach, monitoring her frequently, and adequately repositioning and supervising her, the facility did not implement these interventions. Tr. 100, 104 - 05.

On August 21, 1999, a nurse aide transferred Resident 39 to her bed after dinner and left her bedside without offering her toileting assistance or placing her call light within reach. CMS Ex. 3, at 38; CMS Ex. 17, at 5. About one-half hour later, this resident attempted to stand without staff assistance. The nurse aide returned and again placed the resident in bed without taking her to the toilet. Less than an hour later, the resident was in her bed attempting to remove a soiled incontinence brief. Id. On August 24, 1999, Resident 39 was left in her room with both three-quarter unpadded siderails up. CMS Ex. 3, at 38 - 39; CMS Ex. 17, at 6. For two hours, she was attempting to exit her bed by scooting to the mattress' edge and placing her legs between the mattress and siderails. Id. Two days later, she was sitting alone in a darkened room without her call light within reach. CMS Ex. 3, at 39; CMS Ex. 17, at 24.

LPN Griffin testified for Petitioner that Resident 39 would not be careful and would attempt to do things for herself that she could not do and then would fall. Tr. 673 - 74. LPN Griffin said the facility tried different interventions but mentioned only trying to anticipate Resident 39's needs and providing her with a special plan for toileting. Id. But, by not taking Resident 39 to the toilet, and by leaving her alone without a call light available, as observed by the surveyors, Petitioner was not implementing its plan for Resident 39 and she was not receiving the services necessary to attain her highest practicable physical and mental well-being as set forth in her care plan.

Resident 31 had diagnoses including peripheral vascular disease with neuropathy of the feet, arthritis and blindness. Tr. 107; CMS Ex. 3, at 39; CMS Ex. 18, at 1. This resident's care plan required daily skin checks of her hands and feet for circulation, pedal pulses, coldness, color and signs and symptoms of decreased blood flow. CMS Ex. 3, at 39; CMS Ex. 18, at 8. On August 25, 1999, this resident's left great toe was very swollen and painful to touch with an open, draining sore on it. Tr. 107; CMS Ex. 3, at 40; CMS Ex. 18, at 3, 12. Resident 31 told the State agency surveyor that a nurse aide had injured her toe two days earlier on August 23, but that no one on the staff had cared for or attended to the injury. CMS Ex. 18, at 4. Neither the assistant director of nursing nor the nurse aide supervisor knew of this resident's injury. Tr. 107, 109. The resident's clinical notes contained no record of the injury. Tr. 109.

Petitioner asserts - but did not submit supporting evidence - that it promptly responded to this injury and obtained physician's orders for treatment and a podiatry consultation. Petitioner does not even contend that the treatment referred to was provided prior to the surveyors' notification to the staff that Resident 31's toe was injured. ⁽⁸⁾ According to Petitioner, Resident 31 was extremely restless and confused and had a diagnosis of peripheral neuropathy, leaving her prone to an infection. Petitioner provided no evidence for this assertion. ⁽⁹⁾

Resident 14 was 80 years old and had diagnoses including hypertension, dementia, cerebral vascular accident and chronic vascular insufficiency. Tr. 110 - 11; CMS Ex. 3, at 40; CMS Ex. 19, at 1. Facility records for this resident on August 25, 1999, identified an ulcer on his right foot that measured .25 x .25 centimeters. CMS Ex. 19, at 16. One day later, the ulcer had grown significantly and was measured to be 1.2 x .9 centimeters with red surrounding tissue. CMS Ex. 19, at 8. The State agency surveyor had observed a nurse aide pushing this resident in a wheelchair and his feet were bumping and dragging on the floor. CMS Ex. 3, at 41; CMS Ex. 19, at 6. A physician had ordered a protective dressing for the resident's feet, but the dressing had not been applied when Resident 14 was observed on August 24, 1999. Tr. 113; CMS Ex. 3, at 41. On August 26, 1999, the State agency surveyor saw that Resident 14's pants were wet with urine from his crotch to his knees. Tr. 116; CMS Ex. 19, at 8. He complained to the surveyor that no one would take him to the bathroom. Id. Sitting for long periods, especially in urine, contributes to skin breakdown. Tr. 116, 118.

LPN Griffin testified that because of Resident 14's diagnoses of chronic vascular insufficiency, the facility staff would try to keep his feet elevated to reduce swelling and increase blood circulation. Tr. 676. According to LPN Griffin, Resident 14 was supposed to be up in a wheelchair with leg extenders to elevate his feet and to make sure he was in bed when he was sleepy so that he would not fall out of his chair. Tr. 677. She did not explain why the staff allowed Resident 14's feet to drag and bump on the floor nor why no dressing had been applied to Resident 14's feet as ordered.

According to Petitioner's records, a March 1999 physician's order requests that Ted hose be placed on Resident 14 and that an eggcrate mattress be placed on his bed to prevent skin breakdown. P. Ex. 40, at 1. Indeed, the facility had several physician's instructions on hand to deal with Resident 14's pressure sores, such as applying dressings and cleansing solutions. Id. at 4 - 5. Other plans for protecting Resident 14's skin on record at the facility included skin grid, turning and positioning. Id. at 27 - 30. Petitioner's evidence, however, does not respond to CMS's allegations. The point is that Resident 14 was not getting the services his care plan indicated were to be provided. Rather, Petitioner makes claims unsubstantiated by expert testimony that vascular insufficiency makes pressure sores unavoidable. Petitioner quotes P. Ex. 40, at 25, in its brief at 9, but the quote states that Resident 14's decline was unavoidable. It does not say that pressure sores on Resident 14's feet were unavoidable. Moreover, while Petitioner argues that physician's orders were in place for interventions related to pressure sores, such as Ted hose and an eggcrate mattress, Petitioner does not present evidence that such measures were actually implemented.

As noted above, this resident thrashed about in his bed due to his Huntington's Chorea. Tr. 575 - 76; CMS Ex. 3, at 43. On August 24, 1999, the resident was thrashing and repeatedly striking the unpadded footboard with his right toe as a result of his involuntary, spastic movements. Tr. 575 - 77. The lack of padding could inhibit healing of his toe. Tr. 580. This resident's bed also had metal, three-quarter siderails without sufficient padding. The padding did not prevent contact between the resident's body and the metal siderails. Tr. 579. The resident had yellow and reddish-brown stains on the sheet underneath his left elbow, with a layer of skin lost on the elbow. Tr. 579 - 81; CMS Ex. 21, at 8. Most importantly, with respect to Petitioner's failure to provide necessary services to Resident 74, he had a scabbed-skin sore on the outer part of his right toe without any dressing covering the sore, even though there was a doctor's order for a dressing. Tr. at 575 - 78, 623, 639 - 40; CMS Ex. 21, at 24.

Petitioner provided no response with respect to this cited deficiency and Resident 74.

At the time of the August survey Resident 49 was 99-years-old with diagnoses including microcytic anemia, ischemic heart disease, and dementia. CMS Ex. 22, at 1, 10. She was at high risk for skin breakdown. Tr. 582; P. Ex. 35, at 43. She was unable to determine when she needed to turn and reposition herself. She was totally dependent on the staff for turning and repositioning. Tr. 583. Resident 49's ischemic heart disease decreased the blood flow to her extremities and increased the likelihood of skin breakdown. Tr. 583 - 84. Her anemia also increased her risk for skin breakdown. Id.

On August 24, 1999, Resident 49 was seated in a geri-chair for almost six hours without a position change. Tr. 584. On August 25, this resident was seated in a geri-chair for over two and a half hours without a position change. Id. On neither day did her geri-chair have a pressure relieving device and the staff failed to place a barrier between this resident's knees to prevent skin-to-skin contact and skin breakdown even though required by facility policy to do so. Tr. 585 - 86.

Petitioner responds to CMS's allegations by stating that Resident 49 never had a skin breakdown. P. Br. at 11. LPN Griffin testified as much. Tr. 679. Nonetheless, the facility policy for residents without skin breakdown was to use cushions on chairs and to turn the residents every two hours. P. Ex. 35, at 27. Obviously, this policy was not implemented for Resident 49. Tr. 584 (Resident 49 seated for long periods); Tr. 585 (no pressure relief device on her chair); Tr. 585 - 86 (no protection from knee-to-knee contact). Thus, she did not receive necessary services as determined by facility policy or her plan of care.

This 84-year-old resident had a left hand contracture. Her physician had ordered a four-by-four gauze to be placed in her left hand between her thumb and forefinger due to her risk for skin breakdown on her left hand. Tr. 590 - 92; CMS Ex. 23, at 4. The surveyor did not see gauze on the resident's hand at any time during the survey. Tr. 591.

Petitioner argues that this resident had no skin breakdown through most of 1999 until August 25, when a pressure area developed on her foot. P. Ex. 41, at 4 - 5. Surveyor Slusher-Rose spotted the new pressure sore on the bottom of Resident 50's foot. Tr. 597. Petitioner did provide evidence that Resident 50 was given range of motion exercises twice a day, three to five times per week. P. Ex. 41, at 11. Additionally, the application of dressings between Resident 50's thumb and forefinger was documented by the facility staff. Id. at 12 - 13. Petitioner argues no pressure area ever developed in this resident's hand. Petitioner also contends that the resident was verbally abusive and physically combative during range of motion exercises for her hands and fingers. Id. at 14. Such combativeness, however, does not absolve the facility from providing necessary services.

The facility identified Resident 62 as a moderate risk for skin breakdown. Tr. 592 - 94; CMS 16, at 8. She was totally dependent on the staff for mobility, transfers and ambulation. Tr. 595; CMS Ex. 16, at 3. The facility's policies required residents who are confined to bed be turned at least every two hours. CMS Ex. 16, at 18. Even when a resident has a seizure disorder and is sleepy after a seizure, a resident at risk for skin breakdown should be turned regularly. Tr. 633. On August 25, the State agency surveyor saw Resident 62 lying in bed for six hours without a position change. And, on the next day, she observed her in bed for two and a half hours without a position change. CMS Ex. 3, at 46; Tr. 595 - 96.

LPN Griffin testified for Petitioner that Resident 62 never had a skin breakdown while at the facility. Tr. 679 - 80. As stated above, however, no actual harm is required to show a deficiency. Petitioner provided no further evidence in response to CMS's allegations regarding Resident 62. Thus, Petitioner failed to rebut CMS's evidence that Petitioner did not provide necessary services as determined by facility policy.

Petitioner makes a number of arguments in its posthearing brief regarding this tag. In particular, Petitioner contends that this deficiency citation should only be used for quality of care issues not covered by section 483.25(a) through (m). According to Petitioner, these deficiencies should have been cited under Tags F 324, 314, and 328. This argument does not respond to the allegations. Although the deficiencies may have been cited under different tags, the deficiencies still fit within the cited deficiency. Problems found at nursing homes can often be interpreted and cited under different regulatory requirements. The issue is whether CMS has proved that Petitioner was not in compliance with Tag F 309. Beechwood Sanitarium, DAB No. 1906 (2004).

b. Petitioner's failure to provide necessary care and services presents the potential for more than minimal harm.

For the residents described above, the facility's failure to provide necessary care and services caused either actual harm to the residents or the potential for more than minimal harm. For example, Resident 39 was not toileted at appropriate times and was actually harmed by having to sit in a soiled incontinence brief. Failure to toilet also carried the potential for lessened continence and accidents because Resident 39 tried to get out of bed to go to the toilet. Tr. 104, 128, 462 - 63. Resident 31 suffered actual harm for two days with a greatly swollen and infected toe without any assistance from Petitioner's staff. Tr. 107, 110. Resident 14 suffered actual harm from the lack of a dressing on the sore on his foot, and the potential for more than minimal harm existed from his having to sit in urine which can lead to skin breakdown. Tr. 266, 275. Similarly, Residents 49, 50 and 62 faced the potential for skin breakdown, which is clearly more than minimal harm. Resident 74 suffered actual harm with injuries caused by his thrashing and hitting unpadded parts of his bed frame.

5. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25(c).

Section 483.25(c) of 42 C.F.R. requires a facility to ensure that a resident who enters the facility without pressure sores does not develop them unless the resident's clinical condition demonstrates that pressure sores were unavoidable. Moreover, the facility must ensure that a resident who has pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

a. With respect to four residents, Petitioner failed to rebut CMS's prima facie case that it did not ensure that residents who entered the facility without pressure sores did not develop them unless unavoidable and/or that residents with pressure sores received necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

Resident 24 had medical conditions that placed her at risk for pressure sores. Tr. 118, 680. Facility records note that on August 17, 1999, Resident 24 had a Stage II pressure sore on her coccyx that measured .25 x .25 x .25 centimeters with a Stage I sore surrounding it. CMS Ex. 24, at 4. The facility first identified this sore on April 20, 1999. By August 26, the same pressure sore had increased in size to .8 x .4 x .4 centimeters. The surrounding area had also increased. CMS Ex. 24, at 12, 14. According to CMS, Resident 24 had no pressure relieving devices on her bed or chair at any time during the survey. CMS Ex. 3, at 56; CMS Ex. 24, at 5 - 9. On August 21, 1999, Resident 24 was in a chair in her bedroom for over three hours without any pressure relieving device on her chair and without incontinence care. CMS Ex. 3, at 56. On August 24 and 25, the resident was up in a chair for two hours without a pressure relieving device on her chair. Id.

LPN Griffin testified for Petitioner that the usual practice for CNAs at the facility was to turn each resident at the beginning of the shift and to return in two hours to reposition the resident. A supervisor's responsibility was to make rounds and to assure that the residents were turned. Tr. 680 - 81. She said that ". . . we try our best to make sure that our residents are turned and repositioned. And it may not be every two hours on the dot. We may be 10 or 15 minutes late, but they're gonna get turned." Tr. 682. In addition, Petitioner's records show that Resident 24 had an order for an ointment to be applied to the buttocks and perineal area twice a day as a preventive measure. P. Ex. 37, at 2 - 3. An attending physician examined Resident 24 on August 2, 1999, and found her skin to be within normal limits. P. Ex. 37, at 7. Petitioner also submitted the July and August monthly summaries for Resident 24 that note no skin breakdowns for her. P. Ex. 37, at 15 - 17. (As opposed to this report, however, the surveyor observed that Resident 24 actually did have a pressure sore in August 1999.) Petitioner also points out that Resident 24's physician ordered an eggcrate mattress for her bed. P. Ex. 37, at 2, 3, 5.

Petitioner did not respond to CMS's evidence that, on August 26, 1999, a State agency surveyor observed treatment for this resident's pressure sore. A staff nurse removed Resident 24's urine-soaked brief and the resident's open pressure sore had no dressing applied to it even though the resident had a physician's order for a dressing. CMS Ex. 3, at 56; CMS Ex. 24, at 14.

I find that the pressure sore on Resident 24 observed by the surveyor increased from August 17 to August 26, 1999, and this was likely exacerbated by the fact that she was allowed to sit for over three hours on her chair without any pressure relieving device on the chair. Regardless of the facility's alleged policy on repositioning residents and LPN Griffin's testimony that staff turned the residents regularly, the absence of a dressing on Resident 24's sore alone supports my finding that Petitioner did not do all it could to promote healing of Resident 24's pressure sore. A dressing provides protection as well as an environment for healing of a pressure sore. Tr. 118.

Resident 29 had a pressure sore on her coccyx. Tr. 122; CMS Ex. 9, at 28. Resident 29's diagnoses put the resident at risk for skin breakdown but did not make the skin breakdown unavoidable. Tr. 121 - 23. Petitioner's nursing staff had documented Resident 29's pressure sore on August 17, 1999, as a Stage II measuring .1 x .5 x .25 centimeters. CMS Ex. 9, at 4. By August 26, at the survey, Resident 29's pressure sore had increased in size to .4 x .1 x. 3 centimeters with a yellow area of 2.3 x .8 centimeters surrounding the pressure sore. The sore had a brown drainage. CMS Ex. 9, at 28.

The State agency surveyor observed Resident 29's pressure sore treatment on August 21, 1999. The surveyor saw dried feces on this resident's buttocks. Dried feces suggests that Resident 29 had a soiled diaper long before the care observed by the surveyor. Tr. 124. The feces was beneath the sore's loose dressing and in contact with the pressure sore. Tr. 124; CMS Ex. 9, at 5. During treatment, the nurse's gloves became visibly soiled with feces but the nurse did not remove the gloves before irrigating and wiping the open pressure sore with saline. Tr. 126; CMS Ex. 3, at 58. Throughout the survey, the surveyors observed this resident restrained in a wheelchair without any pressure relieving devices on the chair. CMS Ex. 3, at 57 - 58.

LPN Griffin testified for Petitioner that Resident 29 had been to the hospital several times while residing at Petitioner's facility and that Resident 29 would return to them from the hospital with a Stage IV pressure sore. She further testified that the facility healed the pressure sore each time. Tr. 683.

Petitioner refers to P. Ex. 32, at 14, 17, and responds that Resident 29 had orders for an eggcrate mattress which was thereafter changed to an order for an "air low, air loss" mattress. Petitioner's exhibit, however, only shows that the preferred mattress for this resident was unavailable for some time. Id. It does not show that the facility made any particular effort to obtain the preferred mattress for Resident 29 prior to the survey. Petitioner also argues that Resident 29's Foley catheter kept urine away from the skin but submitted no evidence to substantiate its claim. Petitioner further argues incorrectly that the physician's order regarding Resident 29 did not include an order for a pressure relieving device for her chair. In fact, the physician's order says an eggcrate pad should be on her chair when she was in it. P. Ex. 32, at 14, 17.

Petitioner also contends that a nurse aide is not permitted to change a dressing, thus her not changing the dressing was within standard nursing practice. P. Br. at 13. Petitioner provided no evidentiary support for this statement. Further, Petitioner argues that the allegations regarding nursing technique were cited incorrectly and should have been cited under an infection control tag. The fact that CMS has cited a deficiency under one tag that could have been cited under another tag as well is not a valid argument for a finding that a facility was in substantial compliance. By not providing the interventions as stated in the physician's orders and not cleaning her pressure sore as required, Petitioner was not doing what it could to prevent infection or promote healing of Resident 29's pressure sore. See Tr. 127.

Resident 9 was totally dependent on the facility's staff for transfer and ambulation. CMS Ex. 12, at 3. By August 21, 1999, Resident 9 had developed a pressure sore on his left lower buttocks. Tr. 259 - 60; CMS Ex. 12, at 33. He also had four Stage I pressure sores on his ankle or malleolus and three on the outer lateral area of his feet. Tr. 259 - 60; CMS Ex. 12, at 9. He additionally had an open pressure sore on his left ischium. Id. On August 24, 1999, while changing linens on this resident's bed, the staff, using improper technique, pulled the resident's bed sheet out from under him, shearing his skin. Tr. 262 - 63; CMS Ex. 12, at 13. Moreover, even though Resident 9 had a physician's order for heel protectors on his feet when he was in bed, a surveyor observed Resident 9 in bed without heel protectors. His treatment nurse could not locate heal protectors in this resident's room. Tr. 267 - 68; CMS Ex. 12, at 3; CMS Ex. 3, at 60. On August 21, 1999, Resident 9 was also restrained in a wheelchair without a pressure relieving device for around three hours. During this time, this resident was not repositioned, changed, or toileted. Tr. 264; CMS Ex. 3, at 59 - 60; CMS Ex. 12, at 5 - 8. A nurse aide then placed this resident in bed - without a pressure relieving device - and his urine soaked brief was removed. Id.

Petitioner argues that this resident did not have a pressure sore, rather he had an abrasion most probably from someone trying to pick him up in the bed and rubbing his skin against the sheet. Tr. 262 - 63, 687. Regardless of how it occurred, an abrasion is a skin breakdown that must be treated. Petitioner submitted evidence that a number of interventions were planned to prevent pressure sores on Resident 9, including an eggcrate mattress on his bed, and heel protectors. P. Ex. 9, at 54. The evidence does show that Resident 9 refused to leave the heel protectors on while sleeping; he would remove them and throw them across the room. Id. at 55 - 56. Petitioner also contends this resident was on hospice and considered to be in the end stage of his life. P. Br. at 14. Although I might agree that a resident at the end of life should not have to wear heel protectors if the resident does not want to, Resident 9 should not have been restrained in a wheelchair for three hours or allowed to sit in urine, end-stage or not. Both sitting for long stretches and sitting in urine promote pressure sores and prevent healing of pressure sores. Tr. 264 - 66, 271, 588.

Resident 8 had a Stage II pressure sore on her coccyx. Tr. 273; CMS Ex. 11, at 31. According to CMS, she had no proper pressure relieving devices for her bed or chair. Tr. 270; CMS Ex. 3, at 61. Resident 8, who was totally dependent on the facility staff for care, was seated with a restraint on August 21, 1999, for over six hours in a chair without a pressure relieving device. CMS Ex. 11, at 6 - 10; CMS Ex. 3, at 61. As treatment for Resident 8, the facility's care plan required that she be released from her restraint every two hours and walked to help her pressure sore. CMS Ex. 11, at 31.

LPN Griffin testified that if the facility's residents are incontinent or at risk for incontinence, the facility uses preventive creams, peri-care and changes diapers every two hours, or more frequently if needed. Tr. 687. Petitioner also argues that Resident 8's attending physician entered an order for an eggcrate mattress for Resident 8's bed and that her mattress was a pressure relieving device. P. Ex. 24, at 89. Even assuming that Resident 8 did have a pressure relieving mattress, Petitioner did not respond to the surveyor's observation that Resident 8 was left sitting in a chair for over six hours without a pressure relieving device on the chair. Sitting for long periods without a pressure relieving device promotes new pressure sores and impedes healing of existing pressure sores. Tr. 271.

b. The Petitioner's failure to provide services for the prevention and treatment of pressure sores presents the potential for more than minimal harm.

The potential for more than minimal harm is patent in a facility's failure to prevent and treat pressure sores. The regulations, in specifically setting forth participating facilities' requirements with respect to pressure sores, acknowledge the harm caused by pressure sores. 42 C.F.R. � 483.25(c). Pressure sores can lead to infection and certainly cause discomfort and pain to the residents with such sores.

6. Petitioner failed to show by a preponderance of the evidence that it was in substantial compliance with 42 C.F.R. � 483.25(d)(2).

The regulations at 42 C.F.R. � 483.25(d)(2) require a facility to ensure that a resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

a. With respect to six residents, Petitioner failed to rebut CMS's prima facie case that Petitioner did not ensure its residents received appropriate incontinence care treatment and services to prevent urinary tract infections and restore as much normal bladder function as possible.

The facility assessed Resident 39 in June of 1999 as occasionally incontinent of bladder and requiring extensive physical assistance with toileting. The staff placed this resident on a restorative toileting program. CMS Ex. 3, at 62. A restorative program should be designed to help improve a resident's continence. Tr. 128, 274. Surveyor Truett testified, nonetheless, that the program for Resident 39 as designed would not maintain continence because it was planned for only three to five times a week. Tr. 130 - 31. As part of the restorative toileting program, Resident 39's care plan required toileting in advance of need. CMS Ex. 17, at 13. On August 21, 1999, a nurse aide transferred this resident to bed after dinner without offering to take her to the toilet even though the resident had been sitting for almost two hours without being taken to the toilet. Tr. 128; CMS Ex. 17, at 5; CMS Ex. 3, at 63. About 45 minutes later, this resident was pulling at her urine soaked brief. The staff did not change this resident's brief until an hour and one-half later. Id. On August 24, 1999, the resident was observed to have visibly wet herself. When her nurse changed her brief, the nurse did not offer to take Resident 39 to the toilet. CMS Ex. 3, at 63. Two days later, Resident 39 was again left in her wheelchair, for three hours, without an offer of toileting. CMS Ex. 17, at 36.

LPN Griffin testified that, when Resident 39 first came to the facility, the staff did help her with toileting but that the process was painful for her and she flatly refused to get up and use the toilet. She used the bedpan instead. The facility staff unsuccessfully attempted to talk her out of her decision. Tr. 689. LPN Griffin's testimony does not respond to the allegation. Even if Resident 39 preferred to use the bedpan instead of being taken to the toilet, she should have been offered the use of the bedpan in advance of need so that she could maintain continence.

The facility, on March 12, 1999, assessed this resident, who was legally blind, as totally continent of bladder but dependent on the staff for toileting as she required extensive physical assistance with transfers and ambulation. Tr. 132; CMS Ex. 3, at 64. Three months later, in June, the resident was assessed as frequently incontinent of bladder and still dependent on the staff for toileting. CMS Ex. 18, at 7. On August 24, 1999, Resident 31 was lying in bed. A nurse came into her room and Resident 31 told the nurse that she had wet her brief. Tr. 133 - 34; CMS Ex. 18, at 16. She also told the nurse aide that she knew when she had to use the bathroom but there was no one available to help her. Id. She explained that she was ashamed when she had to urinate on herself. The nurse aide who changed her brief did not offer to take her to the toilet. Tr. 133 - 34; CMS Ex. 18, at 16. On August 25, 1999, a nurse aide changed Resident 31's soiled brief and confirmed that the resident had no toilet care for almost three hours. Tr. 134 - 35; CMS Ex. 3, at 64 - 65; CMS Ex. 18, at 14. The nurse aide changed this resident's brief without offering to take her to the toilet. Id. Toileting after meals and at bedtime assists residents in maintaining continence. Tr. 276 - 77. Petitioner did not respond to this allegation with respect to this resident.

On August 21, 1999, a State agency surveyor observed Resident 29 receiving incontinence care. Resident 29 had a urinary tract infection and a history of e coli urinary tract infections. Tr. 136; CMS Ex. 9, at 1. Resident 29 had dried, black feces smashed and dried on her buttocks and under the dressing on her buttocks. Tr. 137 - 38; CMS Ex. 9, at 5. To remove the feces from the resident's buttocks, the nurse aide used dry, rough wipes and caused the feces to be spread over the nurse aide's gloves, Resident 29's catheter tubing and under the dressing on her buttocks. Id. Resident 29 already had a urinary tract infection. Her catheter did not have an anti-reflux valve to prevent urine from running back into the bladder and causing re-contamination. Tr. 139 - 40.

LPN Griffin testified that Resident 29 did have a Foley catheter to help the wounds on her buttocks and the staff administered catheter care every shift. Tr. 690. Petitioner argues that wiping the catheter tubing was required by this resident's care plan (P. Ex. 32, at 47). Catheter care may have been required but that does not change the fact that feces should not come into contact with a catheter tube. Tr. 138 - 39.

Petitioner contends the technique the nurse aide used should have been cited as an infection control deficiency. As noted above, simply because a cited deficiency could be cited under different regulatory requirements does not prove compliance. Beechwood Sanitarium, DAB No. 1906. Moreover, the regulation that CMS cited expressly requires the prevention of urinary tract infections and thus is appropriately used for this allegation. Petitioner further argues that this resident did not develop a urinary tract infection after the allegedly deficient care she received. As stated by the Board in a recent decision, neither the facility's nosocomial infection rate nor the lack of an ensuing urinary tract infection is determinative of compliance. Batavia Nursing and Convelescent Inn, DAB No. 1911 (2004).

On June 28, 1999, the facility assessed Resident 26 as incontinent of bowel and bladder. CMS Ex. 3, at 66. Eventually, the resident was placed on a bowel and bladder program on August 25, 1999. Nonetheless, the facility staff, throughout the survey, failed to offer this resident toileting after meals or at bedtime. CMS Ex. 3, at 66 - 68; CMS Ex. 25, at 3 - 6.

LPN Griffin testified for Petitioner that a bowel and bladder program had been instituted for Resident 26. In her testimony, she was ambiguous about the specifics. Tr. 690 - 91. Petitioner argues that there was ample time between the surveyors' observations for the staff to have offered toileting or to have asked this resident whether she wished to go to the toilet. P. Br. at 16. According to Petitioner, this resident had the ability to inform the staff that she needed to use the toilet. The submitted records suggest that at least occasionally Resident 26 was able to advise when she needed to go to the toilet. P. Ex. 33, at 16, 17, 19, 24, and 26. Petitioner further contends that this resident's care plan identified her toileting ability, her ability to use a call light, and to follow simple directions and instructions. Id. at 2, 3, 25, 36, 38. Nonetheless, Resident 26's June 1999 care plan called for her to be taken to the bathroom after meals and at her request. Id. at 54. Thus, whether or not the surveyor continuously observed Resident 26, she did observe that Resident 26 was not offered toileting after meals even though an offer of toileting after meals was part of her care plan. CMS Ex. 25, at 3 - 6.

The facility's assessment of Resident 30, dated August 3, 1998, noted she had been on a bowel and bladder program with good results. CMS Ex. 3, at 68; CMS Ex. 8, at 33. By February 1, 1999, the facility had discontinued her from a bowel and bladder program and the resident's care plan indicated she was completely incontinent. Tr. 144; CMS Ex. 8, at 29. On August 24, 1999, Resident 30 was left lying on her back for over an hour wearing a soiled incontinence brief. When the nurse aide changed the resident, she did not clean the resident's perineal area before applying a clean brief. Tr. 145 - 46; CMS Ex. 3, at 68.

LPN Griffin testified that Resident 30 had declined after her successful bowel and bladder program and she could no longer comprehend it. Tr. 691. LPN Griffin testified that Resident 30 was given incontinence care because, if she had not received it, she would have had skin breakdown and that, in general, ". . . our nursing home doesn't smell of urine. If you're not giv[ing] incontinence care, you're gonna get odor . . . . I feel our staff does a very good job of keeping our residents dry." Tr. 692.

Petitioner further argues that this resident, who expired several days after the survey, was at the end stage of her life and only comfort measures, rather than a restorative program, should have been used. P. Br. at 17. While I agree that a restorative program for Resident 30 may not have been appropriate at the time of the survey, no resident should be left lying in urine and should be cleaned before application of a new brief, allegations that were not rebutted by Petitioner.

On August 21, 1999, a State agency surveyor observed Resident 9 attempting to transfer himself from his wheelchair to the commode. Tr. 274; CMS Ex. 3, at 72 - 73. The surveyor secured help for the resident and a nurse aide removed a saturated and heavily soiled brief from the resident. Resident 9 then urinated on command. When this resident had finished urinating, the nurse aide reapplied the urine-soaked brief on the resident. This resident was not on a bowel and bladder restoration program. Tr. 274 - 75; CMS Ex. 3, at 72 - 73.

LPN Griffin testified that a program was in place for Resident 9 to check and change his briefs, but Resident 9's family did not want him bothered or stressed or moved around a lot because of his heart condition. Tr. 693. Petitioner argues that this resident, as evaluated in July 1999, was totally dependent on staff for all toileting needs. P. Ex. 9, at 41. He had been on a bowel and bladder program. Id. at 38. He was a hospice resident with only pain and anxiety medications. ⁽¹⁰⁾ According to Petitioner, P. Ex. 9, at 52 - 78 details Resident 9's incontinence care, but this document only indicates that the plan was to change Resident 9 every two hours and does not address whether the plan was implemented. Moreover, Petitioner did not address CMS's evidence that a staff person re-applied a urine-soaked brief to Resident 9. Resident 9 already had skin breakdown. Reapplying a urine-soaked brief creates more skin breakdown because of the caustic effect of urine. Tr. 275.

Petitioner claims in its brief that urinary tract infections are common in the elderly and hard to control. For support, Petitioner cited and quoted from a textbook that was not offered in evidence, nor did Petitioner provide any evidence that the text is accepted as authoritative. The fact that urinary tract infections may be more common in the elderly simply supports the proposition that facilities must provide good incontinence care to residents. Petitioner contends additionally that residents who are near death should not be in a bladder restoration program. This argument has some intuitive appeal but does not respond to the facility's failure to provide toileting in advance of need or to change residents' briefs in a timely manner.

b. Petitioner's failure to provide appropriate incontinence care and services to prevent urinary tract infections and to restore as much normal bladder function as possible caused either actual harm or the potential for more than minimal harm.

Failure to provide appropriate incontinence care causes the actual harm of shame to many residents, such as Resident 31. Tr. 133. The failure to toilet regularly and to have a restorative program carries the potential of diminished continence, which is certainly more than minimal harm. Tr. 276 - 77. Failure to toilet or change a soiled brief and changing incontinence briefs incorrectly has the distinct potential for causing urinary tract infections and/or pressure sores, a clear harm to frail residents. Tr. 138 - 39, 266.

7. The CMPs assessed against Petitioner are reasonable.

Petitioner did not present testimony at the hearing regarding the reasonableness of the amounts of the CMPs assessed against it. Nor did it raise the issue in its posthearing brief or reply brief. Petitioner provided no evidence or argument regarding its compliance history, financial condition, or degree of culpability that could be used to consider the reasonableness of the CMP amounts. Nor did CMS provide evidence - other than an "OSCAR" report and a financial statement - regarding the reasonableness of the CMPs. CMS Exs. 6, 93. CMS, however, need not produce evidence relating to the factors in 42 C.F.R. � 488.438(f) unless the facility timely contends some listed factor(s) makes the CMP unreasonable. Community Nursing Home, DAB No. 1807, at 20 (2002). Nonetheless, an ALJ is to make a de novo review of the factors listed in 42 C.F.R. � 488.438(f) to evaluate whether a CMP is within a reasonable range.

The factors I must consider under 42 C.F.R. � 488.438(f) are: the facility's history of noncompliance, the facility's financial condition, the factors listed in 42 C.F.R. � 488.404, and the facility's degree of culpability. The factors listed in 42 C.F.R. � 488.404 include the scope and severity of the deficiencies, and the relationship of one deficiency to other deficiencies resulting in noncompliance. The regulations define culpability as neglect, indifference, or disregard for resident care, comfort or safety. 42 C.F.R. � 488.438(f)(4).

Petitioner has not contended that its financial condition will be affected substantially by the payment of the assessed CMPs or that it cannot pay the CMPs. The regulations authorize a per day CMP in the range of $3,050 to $10,000 in cases where the noncompliance presents immediate jeopardy to residents. The CMP assessed against Petitioner for the period of immediate jeopardy is $5,150 per day, a figure in the middle of the immediate jeopardy range. In this case, CMS presented no evidence that any of Petitioner's residents were actually seriously injured as a result of Petitioner's failure to comply with 42 C.F.R. � 483.25(h)(2). Nonetheless, it is clear serious danger was likely given the inappropriate application of the restraints. With regard to its scope, the facility's deficiency affected at least six residents. Moreover, Petitioner has had a relatively poor compliance history. Petitioner's failure to ensure adequate supervision and assistance devices had been cited in a prior survey. CMS Ex. 93. Additionally, in several instances, Petitioner's staff members appeared indifferent about the plight of the residents who were restrained. They walked by the doors of residents, such as Resident 74, without coming to the resident's aid. My consideration of these various factors suggests that the amount of the per day, immediate jeopardy CMP is reasonable.

Per day CMPs for non-immediate jeopardy deficiencies can range from $50 to $3,000 per day. CMS's assessment against Petitioner of $1,150 is also in the middle of the range for per day CMPs in non-immediate jeopardy situations. The scope of the deficiencies shown by CMS is wide, as each deficiency affected a number of residents. Moreover, the seriousness of the deficiencies was fairly high because of actual harm that residents incurred as a result of the noncompliance. Also, Petitioner's noncompliance history, and its prior deficiencies related to prevention of accidents and care of pressure sores, suggest the CMP should not be at the bottom of the range. Although I found for the Petitioner on one of CMS's claimed deficiencies, CMS proved a sufficient number of deficiencies at a scope and severity to support the assessed CMP. For these reasons, I find the per day CMP assessed against Petitioner for its non-immediate jeopardy period of noncompliance is reasonable.

8. Other arguments presented by Petitioner are not persuasive.

A number of arguments Petitioner presented do not relate to a particular deficiency citation or to particular residents.

a. The correct standard for the burden of proof, as set forth in Hillman Rehabilitation Center, DAB No. 1611 (1997), has been reaffirmed and explained by the Board.

In its brief, Petitioner presents its view that this tribunal has employed an incorrect evidentiary standard that shifts to a petitioner an inappropriately high burden of proof. P. Br. at 22 - 26. The Board has considered this argument on a number of occasions and has confirmed its view that CMS must first make a prima facie case of noncompliance and a petitioner must then rebut that showing by a preponderance of the evidence. Batavia Nursing and Convelescent Inn, DAB No. 1911 (2004). I need not discuss Petitioner's argument further in this decision. I note that the standard expressed in Hillman and Batavia is essentially a preponderance of the evidence standard that is applicable to civil cases generally.

b. CMS may impose a penalty for a deficiency found during a facility's implementation of a plan of correction for a deficiency that was previously cited.

I previously ruled in this case that an approved plan of correction that had not yet been implemented does not innoculate a facility from a finding of noncompliance on a subsequent survey. Ruling and Notice of Hearing, dated April 30, 2002. I stand on my prior ruling. Petitioner indicated in its brief that it intends to preserve this issue for appeal. P. Br. at 26 - 27. Petitioner's objection is preserved.

c. Petitioner was not denied a fair hearing due to evidentiary and procedural rulings I made during the course of this proceeding.

Petitioner objected to a number of rulings I made during the hearing (P. Br. 27 - 29) and, with respect to those that I have not discussed elsewhere in this decision, I make the following comments.

�I could find no prejudice, and Petitioner offered no explanation of prejudice, that allegedly occurred to it because two CMS attorneys were allowed to question one witness based on what portion of the case was assigned to that attorney.

�I find the CMS surveyors that testified did not testify beyond their capacity or outside the scope of their licenses. Petitioner had every opportunity to present witnesses with equal or greater credentials to rebut the surveyors and Petitioner failed to do so.

�The State Operations Manual has repeatedly been ruled as helpful or useful as a guideline in determining compliance with regulatory standards. No error is created by doing so.

�I reviewed the evidentiary rulings I made to which Petitioner excepted and decline to change any of them.

Petitioner's objections to these rulings are preserved for appeal.

d. As stated previously, Petitioner could reasonably foresee accidents with its use of restraints and there were practicable methods available to Petitioner to provide adequate supervision and assistance devices.

Petitioner's Reply Brief was devoted almost entirely to argument about the definition of, prevention of and responsibility for accidents. The discussion of tort law in the brief is interesting but not instructive with respect to the standards set forth in 42 C.F.R. � 483, which refers to requirements on facilities who wish to participate in the Medicare and Medicaid programs.

Petitioner seems to argue that CMS requires too much of facilities. Petitioner contends a nursing home cannot always be in perfect shape; that a resident may not be completely immune from any physical degradation of condition, annoyance, inconvenience, or other occurrence which creates a less than perfect environment. P. R. Br. at 2 - 3. Petitioner is correct that a nursing home may not always be a perfect environment, but there are some reasonable things the taxpayers can expect of nursing homes who are receiving Medicare and/or Medicaid dollars for their services and that includes: taking a resident to the toilet when he or she expresses a need to go; caring for pressure sores; not allowing residents to be left to sit or lie in their own waste; not tying residents to a bed or chair without medical justification; and not leaving residents alone for long periods without adequate supervision. The regulations are designed to protect Medicare and Medicaid beneficiaries and recipients. The standards in the regulations are neither ambiguous nor do they constitute "strict liability."

V. CONCLUSION

For the reasons set forth above, I conclude that Petitioner was not in substantial compliance with Medicare conditions of participation governing nursing home facilities at an immediate jeopardy level from August 23, 1999 through August 30, 1999, and at a non-immediate jeopardy level from August 31, 1999 through October 3, 1999. I also sustain CMS's assessment of a $5,150 per day CMP for Petitioner's period of immediate jeopardy and $1,150 per day for Petitioner's period of noncompliance at a non-immediate jeopardy level.

Anne E. Blair

Administrative Law Judge

1. The transcript of the hearing reflects that I received and admitted P. Ex. 12 into evidence. However, Petitioner did not submit this exhibit at hearing. Instead, Petitioner submitted P. Ex. 15 and that is the exhibit I admitted. With its prehearing exchange, Petitioner submitted copies of P. Ex. 12. I am placing one of those copies into the record and admitting it as P. Ex. 12. Thus, both P. Ex. 12 and P. Ex. 15 are admitted in evidence .

2. I held a prehearing conference on April 23, 2003, at which I requested CMS to narrow the issues for hearing. CMS agreed to proceed primarily on the issues where it assessed a scope and severity level of "G" or above.

3. Petitioner claimed in its brief that it did not call all of its intended witnesses or submit all intended exhibits because of CMS's letter. P. Br. at 2. My ruling on Petitioner's motion to dismiss was at the very beginning of the hearing and Petitioner had ample opportunity to call additional witnesses and submit further exhibits. Tr. 10 - 12.

4. A bed alarm is a device for a resident who may be unable to use a call light. One part of the alarm is hooked to an alarm box that has been attached to a solid surface and the other part is attached to a resident's clothing. The alarm sounds when the resident attempts to change position. Tr. 69.

5. CMS did show that the heads of beds of some of the residents were in an elevated position with the restraints tied to immovable parts of the bed frame, but Petitioner is correct that no State agency surveyor testified that she had observed the bed being raised or lowered with the restraint in position. The opportunity for that possibility was patent, nonetheless. Petitioner could have submitted testimony that it trained its staff on the proper use and application of restraints. No such evidence was submitted.

6. Doctors rely heavily on nursing recommendations when ordering a restraint for a patient. Tr. 56. Rather than the physician initiating the request for a restraint, often a facility staff member will request a resident's physician to prescribe a restraint. Tr. 468 - 69.

7. In its posthearing brief, Petitioner referred to P. Ex. 5, at 1, as being three assessments of Resident 74's dietary needs. Only one of the assessments, however, was dated prior to the survey at issue. Petitioner also referred to a number of its exhibits that it contends are assessments related to Resident 74's falls risk and the use of restraints. None of these documents discuss whether a vest restraint must be used to protect Resident 74 from falls. See, e.g., P. Ex. 42, at 63, 64.

8. In fact, the documents Petitioner referred to in its brief (P. Ex. 31, at 7, 8, 39, and 41 - 42) are all dated August 25, 1999, the same day (or after) the surveyor advised the staff of Resident 31's injury. Tr. 107.

9. Petitioner quoted from a medical text. P. Br. at 8 - 9. Petitioner neither provided any foundation that the text is authoritative nor submitted the applicable portions of the text as an exhibit.

10. Petitioner's reference to a care plan for Resident 9's urinary incontinence (P. Ex. 9, at 11) is dated after the survey.