2000.02.29 CR650 Koester Pavilion vs. HCFA

The findings of fact and conclusions of law, identified here, are discussed below in detail in the Discussion section, section V.

1. A SNF is required to ensure that the resident environment remains as free of accident hazards as is possible. 42 C.F.R. § 483.25(h)(1).

2. A provider's failure to abide by a manufacturer's cautionary instructions is an important factor to be weighed when evaluating potential accident hazards, but does not per se create an accident hazard. To determine whether the manner in which Resident 113's in-bed waist restraint was used was an accident hazard, all the specific circumstances must be evaluated.

3. Posey, the manufacturer of Resident 113's in-bed waist restraint, cautions that while a patient is in bed with a Posey belt (waist restraint) in place, side rails must be in the up position. Posey cautions further not to use any side rail that will allow the patient's body or limbs to fit over, under, around, through, or between side rails and become suspended in the restraint, resulting in chest compression and suffocation. Posey cautions further to use side rail covers (seizure pads), if necessary. P. Ex. 7 at 3; P. Ex. 30 at 77; P. Ex. 76 at 1.

4. The provider used a Posey waist restraint on Resident 113 while he was in bed with side rails in the up position that were 36 or 37 inches long, that is between � and � the length of full length side rails. P. Ex. 47 at 5; P. Ex. 76 at 4; Tr. 354.

5. The provider did abide by the Posey in-bed waist restraint cautionary instructions in the manner in which the provider used the restraint for Resident 113. P. Ex. 7 at 3; P. Ex. 30 at 77;
and P. Ex. 76 at 1.

6. Considering the totality of the circumstances, including for example the properly applied waist restraint which among other things kept Resident 113 in the middle of his bed, Resident 113's slight stature which kept his legs from going off the edge of his bed, and the many means used by the provider to monitor Resident 113 while he was in bed, I find that the manner in which Resident 113's in-bed waist restraint was used was not an accident hazard.

7. The provider was in substantial compliance with the quality of care requirement concerning accidents that is found at 42 C.F.R. § 483.25(h)(1).

8. There was no immediate jeopardy and HCFA's determination that there was immediate jeopardy was clearly erroneous.

9. The provider was in substantial compliance with 42 C.F.R. § 483.25(h)(2), a quality of care requirement to ensure that each resident receives adequate supervision and assistance devices to prevent accidents.

10. The provider was in substantial compliance with 42 C.F.R. § 483.25(c), a quality of care requirement for prevention and treatment of pressure sores.

11. The provider was in substantial compliance with Medicare participation requirements, and HCFA was not authorized to impose a CMP.

This discussion section is divided into three subsections (A, B, and C). Each subsection covers one of the three regulation subsections cited on the Statement of Deficiencies, HCFA form 2567L, specifically 42 C.F.R. §§ 483.25 (h)(1) and (h)(2) and § 483.25(c). Findings of fact and conclusions of law (FFCL) 1 - 8 are discussed in subsection A; FFCL 9 is discussed in subsection B; and FFCL 10 is discussed in subsection C.

A. The provider was in substantial compliance with 42 C.F.R.
§ 483.25(h)(1). There was no immediate jeopardy.

Following the July 1997 survey, HCFA cited the provider with quality of care deficiencies, specifically the subsection of the regulations concerning accidents, 42 C.F.R. § 483.25(h)(1), which states:

42 C.F.R. § 483.25 Quality of care.

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.

. . . .

(h) Accidents. The facility must ensure that--

(1) The resident environment remains as free of accident hazards as is possible; . . . .

To support the allegation that the provider failed to comply with this requirement, the situation of Resident 113 is detailed at tag F 323 on the Statement of Deficiencies. HCFA Ex. 3 at 4 - 6; P. Ex. 30 at 31 - 40. [Of the two versions of the Statement of Deficiencies in evidence, HCFA Ex. 3 is the earlier version. The later, revised version of the Statement of Deficiencies, P. Ex. 30 at 28 - 43, resulted from dispute resolution. P. Ex. 30 at 44 - 45.]

The potential accident hazard identified by the surveyors was the manner in which Resident 113's in-bed waist restraint was used. What alarmed the surveyors was the lack of "full length" or "continuous" side rails for Resident 113's bed, which the surveyors understood to be required whenever a waist restraint was used to secure a person to his bed. Based on their observations of Resident 113, the surveyors assumed that only the "top part" of a split side rail system was in place, and that the "bottom part" of the split side rail system was missing. [The "top part" would refer to the expanse from the head of the bed down toward the middle, along each side of the bed; the "bottom part" would refer to the expanse from the foot of the bed up toward the middle, along each side of the bed.] Theoretically, Resident 113's lower body might slide off the edge of the bed, and his body could slide down in the waist restraint, potentially resulting in entrapment, chest compression and suffocation.⁽²⁾ Tr. 84; HCFA Ex. 10 at 2; P. Ex. 6 at 1; P. Ex. 7 at 2-5; P. Ex. 30 at 77; P. Ex. 76 at 1.

The surveyors evaluated Resident 113's in-bed situation on July 9, 1997, and informed the nursing staff of their concern. As a result, the same day, the staff applied to Resident 113's bed, full and continuous side rails, or side rails that extended from the head to the foot of the bed. Tr. 56-58, 94-95; HCFA Ex. 3 at 5. The surveyors were incorrect in finding that the provider had been using an incomplete split side rail system. The surveyors were told by the provider's staff that the side rail system on Resident's 113's bed was not a split side rail system and that there were no missing or incomplete parts. P. Ex. 30 at 32.

Resident 113's case history and care plan reveal that the provider tried different methods for Resident 113 of preventing falls or injury from falls, prior to ordering the use of a waist restraint in bed. Before a restraint was applied in bed, he had on occasion climbed out of bed over the side rails and fallen. Tr. 114 - 125; P. Ex. 75 at 46. Mattresses were positioned around the resident's bed to prevent injury from any falls. P. Ex. 75 at 42. The provider used a soft lap positioner (lap buddy) and a waist restraint while the resident was in his wheelchair, and a Posey safety body alarm, but the resident repeatedly tried to slide out of his wheelchair to ambulate or disconnected the safety alarm. Tr. 112, 124, 276 - 277, 290; P. Ex. 75. On July 7, 1997, a chest restraint in bed was ordered and discontinued, and a waist restraint in bed was ordered, all on the same day, with instructions that the patient was to be monitored every 30 minutes, and the restraint was to be removed for 10 minutes every 2 hours. P. Ex. 75 at 24; Tr. 353 - 354. The staff did the monitoring as instructed, and, in addition, Resident 113 was monitored from the nurses' station, which was near his room, with audio and video equipment that was in hisroom, and, at times, there was a person stationed just outside the door to his room, and, at times, he was monitored continuously one-on-one. Tr. 282, 290 - 291, 296.

Provider staff testified that Resident 113's in-bed waist restraint, properly applied, permitted him to turn on his axis, but not to shift his body laterally toward the edge of the bed. Tr. 277, 294 - 295. Provider staff testified that Resident 113's legs were too short to reach over the edge of the bed while he was in the waist restraint, so it was impossible for him to have slid off the bed and become entrapped in the restraint. Tr. 282, 291, 302. The provider maintains that a full length side rail is 57 inches long, and that Resident 113's bed side rails, at 37 inches long, were approximately three-quarters the length of full length side rails. P. Ex. 47 at 5; P. Ex. 76 at 4; Tr. 292 - 293, 354. Resident 113's bed was an average-sized hospital bed, 84 inches long according to the parties' stipulation. Tr. 351 - 352. The provider agrees that the waist restraint manufacturer's instructions state that side rails must be in the up position when using restraints, pointing out that Resident 113's bed side rails were up. The provider maintains that Resident 113 did not need full length covered side rails to receive care and services properly and appropriately and shows that the restraint manufacturer does not mandate that full length side rails or side rail covers be used. [The provider is correct under at least three versions of the waist restraint manufacturer's instructions.] The provider maintains that the side rails it was using for Resident 113 were continuous, in that it was not using a split side rail system.⁽³⁾

At the time of the survey, the provider was virtually tie-restraint free. Out of a census of 143 residents, the way a waist restraint was used in bed was an issue for only one resident, Resident 113. The provider was not cited for any other deficiencies relating to restraints, and it did not have a history of such violations. When the surveyors observed Resident 113 lying in his bed on July 9, 1997, his waist restraint was properly applied, and he was secure and comfortable. Tr. 31 - 32, 88; HCFA Ex. 3 at 5. Resident 113 was an elderly gentleman, slight of stature and weight. He was four feet ten inches, or four feet eleven inches, tall (Tr. 275, 332), weighing about 130 pounds. He was diagnosed as having Alzheimer's disease, assessed by the provider's staff as having cognitive loss with moderately impaired decision-making skills, confused, disoriented, wandering frequently, and having periods of motor restlessness. P. Ex. 75 at 8, 13, 54; Tr. 275.

Two Food and Drug Administration (FDA) safety alerts are in evidence. The first, an FDA Safety Alert dated July 15, 1992, entitled "Potential Hazards with Protective Restraint Devices," warned of potential hazards in using restraints (HCFA Ex. 9 at 2-5; P. Ex. 5 at 2 - 5) and included an instruction to follow the manufacturer's directions for use. Side rails were not specifically mentioned in connection with that instruction, however.

The second FDA Safety Alert, dated August 23, 1995, entitled "Entrapment Hazards with Hospital Bed Side Rails," included precautions against entrapment hazards. It is clear from this Alert that side rails can present a danger to a person restrained in bed. Although the reported entrapments⁽⁴⁾ are not similar to the potential danger at issue here (ALJ Ex. 1 at 1), this Alert also recommended following the facility's protocol and the restraint manufacturer's instructions for proper use, in addition to the federal, state, and local regulations regarding the use of protective restraints. ALJ Ex. 1 at 2.

Did the provider follow the in-bed waist restraint manufacturer's instructions for proper use? HCFA says no; the provider says yes. Both are correct, depending upon which version of the manufacturer's instructions is applied. The in-bed waist restraint manufacturer is Posey.⁽⁵⁾ There are at least four versions of Posey instructions in evidence.

The different versions of Posey's safety instructions in evidence require me to determine which version is applicable here. There is a critical difference, for example, between Posey's warnings in HCFA Ex. 10 (see also P. Ex. 6) and Posey's warnings in P. Ex. 7. The earlier cautionary instruction warns to use full length or continuous side rails and not to use � or � side rails. HCFA Ex. 10; P. Ex. 6. The version Posey printed a year later deleted such admonitions.

Below, I discuss which version of Posey safety instructions is applicable here. First, though, I address whether failure to heed a waist restraint manufacturer's cautionary instructions creates an accident hazard. The answer is not necessarily, as it depends upon all the circumstances evaluated as a whole. A provider's failure to abide by a manufacturer's cautionary instructions is an important factor to be weighed when evaluating potential accident hazards but does not per se create an accident hazard. A manufacturer may foresee and warn against all potential risks and hazards in the use of its products. A manufacturer may change its warnings with increased awareness and experience with the product. A manufacturer's warnings may promote safe use of a product and may help insulate the manufacturer from liability in the event of harm. Here, there was no injury or harm to Resident 113. If there had been injury or harm, and if the provider had failed to heed the manufacturer's warnings, such failure might have kept the manufacturer from being found to blame and might have exposed the provider to greater liability. To determine whether the manner in which Resident 113's in-bed waist restraint was used was an accident hazard, all the specific circumstances must be evaluated.

Tag F 323 in the Statement of Deficiencies⁽⁶⁾ includes the following excerpt:

When the State survey agency quoted Posey instructions on the Statement of Deficiencies, which Posey version did the State survey agency have? The variation of the language of the Statement of Deficiencies as originally crafted (HCFA Ex. 3 at 5), compared to the language of the Statement of Deficiencies as revised (P. Ex. 30 at 32), is one indication that the surveyors may not have had the applicable manufacturer's instructions. The State survey agency seems to have had the version contained in HCFA Ex. 10 at 1, �8 and P. Ex. 6 at 1, �8, when the revised Statement of Deficiencies was prepared. HCFA's Ex. 10 points me to a version of the "Instructions for the Use of Posey Restrictive Products," which includes:

At first, these Instructions for the Use of Posey Restrictive Products (HCFA Ex. 10 at 1; P. Ex. 6 at 1) appear to relate to vest restraints, not waist restraints of the type being used on Resident 113. This is particularly so, since the reverse side, Application Instruction Sheet Posey Criss-Cross Vests (HCFA Ex. 10 at 2; P. Ex. 6 at 2) is solely about vests, and states at the bottom, "See Other Side For Safety Instructions." Nevertheless, �5 refers to the "sizing chart below for vests, jackets, and belts," and the small chart at the lower left portion of the page, entitled "Sizing Table for Posey Products" includes the statement: "Posey belts are not color-coded, but are sized according to this table." Id. After careful study of HCFA Ex. 10 at 1 and P. Ex. 6 at 1, including the references to belts, I find that this Posey instruction does apply to waist restraints (belts) such as that being used on Resident 113. Thus, this version of the waist restraint manufacturer's instructions cautions against using � or � length side rails while the patient is in bed with the Posey belt or waist restraint in place.

The Posey instructions found in P. Ex. 7 at 3, however, which were printed a year later (1993 instead of 1992), have a rewritten �8. There is no recommendation for full and continuous covered bed siderails and no caution against using � or � length side rails. That document is entitled "Safety (emphasis added) Instructions for the Use of Posey Restrictive Products":

Here again, �5 refers to the "sizing chart below for vests, jackets, and belts," and the small chart at the lower left portion of the page, entitled "Sizing Table for Posey Products" includes the statement: "Posey belts are not color-coded, but are sized according to this table." Id. Here again, I find that this Posey instruction does apply to waist restraints (belts) such as that being used on Resident 113.

The provider apparently had the Posey version that is shown as Exhibit A attached to its Plan of Correction.⁽⁷⁾ P. Ex. 30 at 32, 77. In pertinent part it warns, "All siderails MUST be in the up position when using restraints. If necessary, use a siderail cover especially with split siderails, to prevent the patient's body from going under, around, through or between the siderails." There is no caution to use a full length or continuous side rail.

There is no caution against using � or � length side rails. A different version with nearly identical language regarding the side rails is P. Ex. 76 at 1, �8

I find that the Posey version printed in 1993, which is a more recent version than that used by HCFA, is most meaningful for the survey in 1997. This 1993 version is quoted in pertinent part a few paragraphs above. P. Ex. 7 at 3. Particularly significant is the way Posey has refined its instructions. There is no caution to use a full length or continuous side rail. There is no caution against using � or � length side rails. Consequently, under this version of Posey's instructions, in addition to the versions found at P. Ex. 30 at 77 and P. Ex. 76 at 1, the provider did abide by the manufacturer's cautionary instructions.

Next, I evaluate whether the provider was ignorant of the manufacturer's requirements, and whether the provider's nursing staff were "unaware of the proper use of siderails with the use of restraints in bed," such as to create a potential accident hazard. I find no evidence to support such a theory. The surveyors misjudged the provider's awareness and were mistaken when they told the provider's Director of Nursing that the waist restraint could be used only with full side rails. P. Ex. 30 at 38.

To evaluate the risk of harm, I consider all these circumstances as a whole. My holding here is based on the unique factors of this situation. In another case I might hold that an accident hazard was created by failure to use full length bed side rails, but not here. Was it possible for Resident 113 to have been injured by the in-bed waist restraint in the absence of full length side rails? No actual injury or harm to Resident 113 occurred. No alarming event occurred. If Resident 113 were to have slid off the edge of his bed and to have become entrapped in his waist restraint, the harm would have been more than minimal; it would have been life threatening. Was there a risk to resident health and safety greater than potential for causing minimal harm? (See substantial compliance definition, 42 C.F.R. § 488.301.) The preponderance of the evidence proves no such risk. Upon careful consideration of all the evidence, I conclude that the manner in which resident 113's waist restraint was used was not an accident hazard. The provider has proved the following, which are among the most important factors that weigh against the existence of a accident hazard: (1) the correctly applied waist restraint; (2) the resident's position in the middle of the bed; (3) the resident's inability to shift his body laterally toward the edge of the bed [he could only rotate on his axis]; (4) the resident's slight stature and legs which were too short to reach over the edge of the bed; (5) the many ways the provider monitored the resident; and (6) the provider's compliance with the manufacturer's instructions by having side rails up that would not allow the Resident 113's body or limbs to fit over, under, around, through, or between side rails. Thus, the provider has proved that it was in substantial compliance with the requirements of 42 C.F.R. § 483.25(h)(1).

Immediate jeopardy means a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident. 42 C.F.R. § 488.301. I find that the provider was in compliance with Medicare participation requirements; as a result, I find that there was no immediate jeopardy. Further, I find that HCFA's determination that there was immediate jeopardy was clearly erroneous. 42 C.F.R. § 498.60(c)(2).

B. The provider was in substantial compliance with 42 C.F.R. § 483.25(h)(2).

Following the July 1997 survey, HCFA cited the provider with a second deficiency in the quality of care category concerning accidents. This second quality of care regulation subsection concerning accidents, 42 C.F.R. § 483.25(h)(2), states:

42 C.F.R. § 483.25 Quality of care.

. . . .

(h) Accidents. The facility must ensure that--

. . . .

(2) Each resident receives adequate supervision
and assistive devices to prevent accidents.

To support the allegation that the provider failed to comply with this requirement, the situations of two residents, Resident 24 and Resident 43,⁽⁸⁾ are detailed at tag F 324 on the Statement of Deficiencies. HCFA Ex. 3 at 6 - 7.

Regarding Resident 24, HCFA determined that the provider was not in compliance with the requirement to ensure adequate supervision and assistive devices to prevent accidents. The surveyor observed skin tears and abrasions on Resident 24's arm and shin. Tr. 190; P. Ex. 71 at 17. The surveyors concluded that the resident had fallen while being assisted to the bathroom on the morning of July 9, 1997. Tr. 190 - 191.

The evaluation for Resident 24 known as the Minimum Data Set (MDS) had indicated a need for two or more persons for Resident 24 for ambulation. Tr. 333. Thus, an issue here is the provider's failure to have two persons assist the resident to ambulate in her room. Ms. Wiley, a registered nurse who completes MDSs and care plans for the provider, testified that on the MDS you have to code for the highest level of assistance given during the seven day assessment period. Tr. 333 - 334. Ms. Wiley testified that in the room, Resident 24 was fine with one assist for short distances with her walker. The resident needed two assists for longer distances, such as in the corridor to the dining room or to the lounge. Tr. 334. At the time of the incident, in which the resident lost her balance and was lowered to the floor with the assistance of the nurse aide, the resident was in her room using a walker, being assisted by the nurse aide. Tr. 334. The skin tears did result from the incident as the nurse aide held onto her. The resident did not fall, but, rather, sat on the floor as the aide held onto her to keep her from hitting the floor hard. Tr. 334.

Ms. O'Brien, a charge nurse who was the skin care coordinator, testified that Resident 24 had very fragile skin and was at risk for skin tears. Tr. 309. Ms. O'Brien had observed and had personally provided one person assists to Resident 24 in her room, with her walker, and testified that those measures were adequate. Tr. 310.

Ms. Stine, a licensed practical nurse (LPN), also testified that Resident 24 needed one person to assist her while she used her walker in her room, ambulating from the chair to the toilet or to the bed. Tr. 253. She would use two assistants sometimes ambulating farther away, such as going to the dining room with her walker. Tr. 254 - 256. The resident's lucidity varied and she required more assistance at some times than at others. Tr. 253. She had a Posey body alarm for safety so that staff were alerted if she was getting up by herself. Tr. 254, 309.

The sheet given to the nurse aide at the beginning of the shift is not specific regarding whether Resident 24 needed two staff members or one to assist her in walking. However, the information is not detailed and is general in nature. P. 71 at 29 - 30, 100, 113. Oral communication from the prior shift supplements the written information. Tr. 335 - 336.

Resident 24's being lowered to the floor on July 9, 1997, was not part of a pattern of falls, and the evidence does not establish other instances where the resident was unable to ambulate safely in her room being assisted by one staff person while using a walker. The evidence viewed in its entirety does not establish that assistance by one staff person instead of two for the trip to the bathroom amounted to a deficiency. Providing quality care includes encouraging and assisting each resident to do as much for herself as reasonably can be done. So long as Resident 24 remains ambulatory, there is some risk of a fall. I find that the provider did everything within reason to provide Resident 24 with adequate supervision and assistive devices to prevent accidents. Thus, with regard to Resident 24, the provider has proved that it was in substantial compliance with the requirements of 42 C.F.R. § 483.25(h)(2).

HCFA cited the provider for failing to supervise Resident 134 (also known as Resident 43 and also known as Resident 131) adequately to prevent his falling and repeated injuries. The surveyors reviewed records for Resident 134, which revealed that he had fallen on January 20, 1997, and fractured his right hip. Tr. 60 - 61, 67 - 69, 73 - 75. The records further indicated that the resident had fallen again on July 2, 1997. On July 3, 1997, X-rays revealed that he had fractured his left leg. Tr. 75; P. Ex. 73 at 2, 32 - 33, 51. Between the falls, on April 30, 1997, the provider had assessed the resident as needing extensive assistance with walking. P. Ex. 73 at 54, 72.

Notations of Resident 134 being on the floor were not necessarily notations of falls. Ms. Gray, a charge nurse, testified that the resident was an attention seeker who would sit on the floor and would announce beforehand that he was going to do it in order to get the staff into trouble. Tr. 297-298. "He would say those words. 'If I fall on the floor, you're going to get in trouble'." Tr. 298. Ms. Gray testified that Resident 134 would fall intentionally to get the response it would bring; "He knew that would bring everybody." Tr. 299. In answer to cross-examination questions, asking if it was her opinion that Resident 134's habit of drawing attention to himself by purposely flinging himself on the floor was the behavior that caused him to fracture his hip, Ms. Gray responded, "Yes." Resident 134 would frequently yell out, "Help, help," when he just wanted attention, according to Ms. Wiley, the registered nurse who does MDSs and care plans. Tr. 336. Resident 134 was admittedly difficult, perhaps impossible, to manage.

Numerous monitoring devices were in place for Resident 134. His medication Prozac may have affected his balance and his gait and thereby increased his propensity to fall. Tr. 82. He had had an alarm to alert the staff that he was changing position, but it was discontinued in February 1997 due to the resident's request. Tr. 78 - 83. He had both a Posey body alarm and a bed alarm. Tr. 298. The staff continuously directed him and redirected him to ask for assistance for ambulation. Tr. 80. Regarding Resident 134's cognitive state, I find that he understood staff requests and was capable of complying but that he deliberately chose not to, thereby making prevention of accidents more difficult.

He was monitored at least every 30 minutes, at times he was supervised one-on-one, and at times he was brought up to the nurses' station, where he could sit and have lots of attention. Tr. 304, 336.

Resident 134's care plan was being implemented appropriately, staff were assisting him, and his behavior made keeping him safe extremely difficult. Resident 134 sustained two serious injuries within a six-month period. While that is alarming, the evidence as a whole, including all of the evidence concerning the resident's behavior, persuades me that the provider had done everything within reason to provide Resident 134 with adequate supervision and assistive devices to prevent accidents. Thus, with regard to Resident 134, the provider has proved that it was in substantial compliance with the requirements of 42 C.F.R. § 483.25(h)(2).

Following the July 1997 survey, HCFA cited the provider with a deficiency in the quality of care category concerning pressure sores. The quality of care regulation subsection concerning pressure sores, 42 C.F.R. § 483.25(c), states:

42 C.F.R. § 483.25 Quality of care.

(1) A resident who enters the facility without pressure sores
does not develop pressure sores unless the individual's clinical
condition demonstrates that they were unavoidable; and

(2) A resident having pressure sores receives necessary
treatment and services to promote healing, prevent
infection and prevent new sores from developing.

To support the allegation that the provider failed to comply with this requirement, the situations of four residents, Residents 24, 44, 30, and 8, are detailed at tag F 314 on the Statement of Deficiencies. HCFA Ex. 3 at 1 - 4.

HCFA cited the provider for failure to provide adequate care regarding Resident 24's blisters (pressure sores) from new shoes.⁽⁹⁾ Resident 24 was previously discussed (in section V., subsection B); she had very fragile skin and was at risk for skin tears. Tr. 309, 333. She had circulatory problems and at times had pedal edema, which is swelling of the feet. Tr. 324.

Resident 24 was dependent on the staff for assistance with all daily activities including dressing. P. Ex. 71 at 100, 104, 108, 113, 114; P. Ex. 74 at 8, 18, 52. She was free from pressure sores until after her family brought her new shoes in June 1997. The new shoes, open-toed shoes that could be adjusted across the tops, were brought to Resident 24 at the request of the resident's podiatrist because of the resident's edema. Tr. 254, 325 - 326. Resident 24 subsequently developed a blister on the side of her foot, for the most part from the shoes. Tr. 176, 254; HCFA Ex. 3 at 2-3; P. Ex. 71 at 101; P. Ex. 74 at 9, 19. She then developed a second blister, on top of her foot, again for the most part from the shoes. The staff discovered, treated, and monitored the blisters, and then noted that the new shoes should not be worn. P. Ex. 71 at 26.

Should the provider should have prevented the blisters? Did the provider give good treatment for the blisters? Ms. Wiley, the registered nurse who does MDSs and care plans, testified that the provider did everything possible to prevent and care for Resident 24's pressure sores. Tr. 324. Ms. Wiley testified that it appeared to the staff that the new shoes appeared to fit. Id. She also described how body assessments were done regularly on Resident 24 in an effort to monitor her skin for signs of pressure sores. Tr. 324.

HCFA counters that nurses' notes indicate that these assessments were done only once per week during the time of the alleged deficiency as opposed to the two times per week as represented by Ms. Wiley. HCFA Br. at 11. HCFA's argument seems to be that the failure to discover the pressure sores immediately and failure to discontinue or adequately adjust Resident 24's shoes immediately is noncompliance. HCFA Br. at 11.

The provider counters that Resident 24's edema, poor circulation, fragile skin, and other medical conditions made her prone to pressure sores. The provider notes that the surveyor who noted the deficiency, Ms. Tobias, had no special knowledge on the subject of skin care and was unaware of the medical conditions purported to predispose Resident 24 for pressure sores. Tr. 194 - 195.

The evidence indicates that there was an occurrence of blistering associated with the new shoes. If a person such as Resident 24 is at risk for developing pressure sores and especially susceptible due to the friction between shoes and feet, special care must be taken in fitting shoes to that person. It was the resident's podiatrist who requested the new shoes, to compensate for the edema and to insure as good a fit as possible. The podiatrist had requested an adjustable sandal type shoe and that is what the family of the resident had brought into the facility. The top of the shoe was adjustable. The shoes appeared to fit, but the breaking in seems to have caused the blister. Tr. 325 - 326.

The surveyor acknowledged that she herself has bought new shoes which caused her to develop a pressure sore area while the shoes were being broken in. Tr. 195. Following is an exchange between the provider's counsel and the surveyor, which is instructive concerning the provider's conundrum in caring for Resident 24's feet:

Q. And, have you ever had a pair of shoes that fit, but took a while to break in?

A. Yes, I have. And--

Q. And, you can't-

A. --in fact, have developed a pressure area.

Q. And, you can't say whether that's what happened here or not, can you? That the shoes may actually well have fit, but just needed time to break in?

A. But, it was the facility's responsibility to make sure that the shoes did not cause a pressure sore on the resident's feet.

It is in the common experience of the average person that shoes, and new shoes in particular, can cause blisters. The provider argues that the facility should not be held to a mathematically precise standard of care in order to be found substantially compliant. The provider asserts that, considering the resident's medical problems and all of the other factors, especially the provider's efforts to prevent and treat pressure sores, the pressure sores were unavoidable. The provider mentions testimony that Resident 24 developed a pressure sore on her ankle, an area where there was no shoe. Tr. 282. The existence of a pressure sore where the shoe did not rub may demonstrate the difficulty in keeping Resident 24 free from pressure sores, but that alone does not prove that the pressure sores on her feet were unavoidable.

HCFA cites Cross Creek Health Care Center v. HCFA, DAB CR504 (1997). Concerning the same regulation at issue here, Administrative Law Judge Steven T. Kessel held at page 50 that a facility must do whatever is reasonably necessary to avoid the development of pressure sores in its residents. The regulation states, in pertinent part, that "A resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable." 42 C.F.R. § 483.25(c)(1). Under the regulation, substantial compliance and pressure sores cannot coexist unless the sores were unavoidable. Unavoidability must be demonstrated by the clinical condition of the resident. Resident 24 was without sores initially and developed sores while in the care of the facility. The burden is on the provider to prove by a preponderance of the evidence (that it is more likely than not) that the resident's clinical condition made the sores unavoidable.

The regulation obviously does not require the provider to ban shoes for its residents who are at risk for pressure sores. It was not the provider's prerogative to prevent Resident 24's new shoes from being tried. As it turned out, she could not tolerate them. Her very fragile skin, which contributed to her being at risk for skin tears, her circulatory problems, and the swelling of her feet, all contributed to the formation of the blisters.

Was it reasonable to expect the staff to have become aware of a reddened skin area on Resident 24's foot in time to intervene and prevent a blister? The blister probably formed very quickly. The provider has proved that its care was diligent and was nearly immediate. The pressure sore site was checked every shift (at least three times per day), and the Polymem dressing, an absorbent type of dressing, was changed every day, once a day, and in between, if necessary. Tr. 261 - 263. Polymem dressing applied on July 1, 1997, for example, is documented in P. Ex. 71 at 2, and the evidence shows frequent skin assessments and care provided to Resident 24. The attending physician was advised of the presence of the sores. Tr. 260. The evidence about Resident 24's blisters taken as a whole persuades me that the provider did everything within reason to prevent and treat Resident 24's pressure sores. This is in accord with the opinion of Ms. Wiley, who testified, "I think we did everything possible that we could have done." Tr. 324. The provider has proved that it was in substantial compliance with the requirements of 42 C.F.R. § 483.25(c) insofar as Resident 24 is concerned.

Like Resident 24, Resident 44 was free from pressure sores upon admission to the facility. Tr. 176; P. Ex. 71 at 101; P. Ex. 74 at 9, 19. The facts and my analysis here are similar to those concerning Resident 24 (above, subsection C.1.).

Resident 44's feet were showing some contracturing from her disease process. She was diagnosed as having ALS (Lou Gehrig's disease) and she had had a prior cardiovascular accident (CVA) or stroke. She had aphasia, so she could not speak very well. She had limited mobility (could ambulate for a short distance with two assists), was totally dependent on the staff for all of her care, and had decreased stamina and decreased appetite. Tr. 256 - 259, 314, 327. These medical conditions placed her at risk for developing pressure sores.

Ms. Stine, an LPN, testified that Resident 44's family had brought her a pair of shoes they insisted that she wear:

Ms. Stine testified that Resident 44's daughter brought the shoes in (Tr. 258), and:

the shoes were monitored and the shoes were removed when the first red area appeared.

Ms. Ribble-O'Brien testified that Resident 44's new shoes were brought in in June. Tr. 314. Ms. Wiley, R.N., testified regarding Resident 44:

The daughter was not happy with this. She stated her mother would never wear shoes like that and she took them home, the tennis shoes that we had provided her, she took them home and put the other ones back on her.

Ms. Wiley testified further that the daughter had said that the shoes she had brought in were the type of shoes Resident 44 had always worn. Resident 44 danced quite frequently in her younger days and she preferred this type of shoe. Tr. 327 - 328.

Q. Let me direct your attention to Resident 44 now.

A. Yes.

Q. I believe that this resident also had new shoes.

A. Yes.

Q. And that your staff preferred that she have a tennis shoe type?

A. Yes, one that fit her better.

Q. Right. And, that it was your opinion that the shoes that the family insisted on were not proper?

A. Yes, they were too small.

Q. Tell me if it's proper nursing practice to put a resident into circumstances that may cause her physical harm such as pressure sores simply because the family requests it?

A. No, that's why we got the tennis shoes.

Q. But you didn't put the tennis shoes on her, did you?

A. Yes, we did.

Q. I thought your testimony was that the family took the tennis shoes back?

A. After a period of time, they did. But, until they came to visit and saw the tennis shoes, that's when they took them - -

Q. And, your staff did nothing about that?

A. We put slippers on her after that.

Q. But, you still - - she was still given the shoes to wear by your staff, is that correct?

A. Per her daughter's request.

Q. Even though it is your opinion that those shoes were improper, correct?

A. Yes.

HCFA argues that there is nothing in the nurses' notes indicating that tennis shoes had been given to the resident as Ms. Wiley had testified. Tr. 326 - 328. HCFA casts aspersions on the veracity of Ms. Wiley's testimony concerning both the provision of the tennis shoes to Resident 44 and the alleged lack of cooperation on the part of Resident 44's daughter with the facility. HCFA maintains that it is telling that there is no entry in the nurses' notes to indicate Resident 44's daughter was not cooperating subsequent to a June 17, 1997 entry that HCFA argues showed Resident 44's daughter was cooperating. However, this entry in the notes refers to a telephone call to the resident's daughter regarding a consent form for a visit to the podiatrist and an indication that new shoes were to be provided by the resident's family. The provision of tennis shoes by the provider and the lack of cooperation by the daughter in providing the correct shoes are not the type of information I would expect to find in the nurses' notes. I find credible the testimony regarding Resident 44's shoes of Ms. Wiley, Ms. Ribble-O'Brien, and Ms. Stine.

The provider took the offending shoes away when the first red area appeared. The provider obtained tennis shoes for the resident, which were more accommodating to the resident's condition than those that the family had provided. The provider requested that the daughter bring in a larger size. The provider made the effort to have a podiatrist determine the footwear needs of the resident. The provider gave healing care to the resident when a blister developed from the offending shoes. The provider advised the attending physician of the presence of the sores. Tr. 260. Considering all the circumstances, the provider did everything within reason to prevent and treat Resident 44's pressure sores. The provider has proved that it was in substantial compliance with the requirements of 42 C.F.R. § 483.25(c) insofar as Resident 44 is concerned.

HCFA cited the provider for failure to provide adequate care regarding Resident 30's pressure sores. The alleged failure regards the possible impact on Resident 30's skin of the new orthotic open-toed boot for his left foot, which he had begun using in June 1997.

Resident 30 was diagnosed as having severe peripheral vascular disease and diabetes mellitus. His right leg had been amputated. He had no use of the left leg or the left arm due to a stroke. Tr. 269. Because of his circulatory problems and other medical conditions, he was more prone to skin breakdown. He would develop blisters on his foot that were not even related to the location of his orthotic boot or anything, where there was no pressure, such as on the tops of his toes. (His toes were exposed.) Tr. 311 - 312, 328 - 329.

The pressure sore which led to HCFA's citation was one of several on the back of the resident's left ankle. P. Ex. 72 at 26, 44, and 57. The surveyor for HCFA observed the pressure sore on the back of the resident's ankle while the dressing was being changed by the staff. Tr. 220, 223 - 224, 362 - 364; P. Ex. 29. The surveyor observed that the plastic underside of the device curved up onto the back of the ankle, and it was her concern that the orthotic boot, apparently designed to alleviate pressure on the sore, may in fact have been putting pressure on the area of the sore. The surveyor detected that there was a potential problem with the new orthotic boot possibly exacerbating the pressure sore on the back of Resident 30's ankle.

The resident had been treated by the physical therapist for the provider and had received the orthotic boot in June. Tr. 224, 363. The orthotic boot was used in accord with the instructions of the physical therapist, and it was a new model used to replace an older model which was unavailable. Id. The provider had been working with the new orthotic boot for one month or less prior to the survey. On July 9, 1997, provider staff telephoned the company where the orthotic boot was purchased. The brace (orthotic boot) was purchased on June 3, 1997, and the company representative Janet Reynolds stated that the brace was state approved and tested and could no way cause a pressure area. P. Ex. 72 at 33.

The evidence does not persuade me that the impact of the new orthotic boot was to increase pressure in the area of the sore or to contribute to skin breakdown. Nor am I persuaded that the provider failed to assess the impact of the new orthotic boot. I am persuaded that Resident 30's pressure sores were unavoidable as a result of his clinical condition and that the provider did all that could reasonably be done to prevent, to assess and to treat Resident 30's pressure sores. I find that the provider was in substantial compliance with the requirements of 42 C.F.R. § 483.25(c) regarding Resident 30.

HCFA cited the provider for failure to provide adequate care regarding Resident 8's pressure sore, for the reason that fecal matter was left on her skin in the area of the pressure sore.

Given Resident 8's balance problems and her size (155 pounds, Tr. 330), it was difficult to hold her up and cleanse her at the same time. It was safer and easier to complete cleaning her in bed, rather than while she was still at the toilet. The surveyor was present when a staff nurse came to change the Tegaderm dressing on the pressure sore, which was on the buttock. Tr. 217 - 218, 251. Nurse aides in Resident 8's room informed the surveyor that they had completed Resident 8's incontinent care and after a bowel movement had returned her to bed. The nurse aides turned the resident over for the nurse to change the dressing. P. Ex. 29 at 201. It was discovered when the nurse proceeded to change the dressing that there was fecal material clinging to the skin in the area of the pressure sore. Tr. 217. The nurse cleaned the area and changed the dressing.

Witnesses for the provider were in agreement with HCFA on two things. First, the nurse aides, while not permitted to change the dressing on the pressure sore, were able to clean the skin around the sore; there was no reason not to clean the fecal matter from the skin in that area. Tr. 233. It was the provider's practice for nurse aides to clean a resident who has soiled herself and tell the charge nurse that the dressing is soiled and needs changing. Tr. 251 - 252. Second, good nursing practice would have included the nurse aides washing the area (one can wash over the top of the Tegaderm), even if they anticipated the imminent arrival of the nurse coming to change the dressing. Tr. 284 - 286.

HCFA concludes from this that under the regulation Resident 8 did not receive the necessary treatment to promote healing and avoid infection of an existing sore and did not receive the necessary treatment to prevent the development of new sores. The provider emphasizes that very little time elapsed between the nurse aides returning the resident to her bed and the arrival of the nurse. The provider argues that there would not have been any benefit for the aides to have cleaned the resident who was about to have her dressing changed. The provider also emphasizes that the Tegaderm dressing covering the pressure sore was impermeable to water. Tr. 230.

The most significant factor here is that the Tegaderm dressing covering the pressure sore kept the existing sore from being affected by the fecal matter. Also, where there were no pressure sores, the fecal matter was not in contact with the skin long enough to contribute to breakdown. It is clear that leaving Resident 8 in a degrading and unsanitary condition was poor nursing practice. This fact, however, does not by itself indicate a deficiency. The evidence proves that this isolated omission neither led to aggravation of the pressure sore nor led to the development of other sores. The provider quickly attended to the presence of the fecal matter, which did not threaten the sore because of the impermeable barrier used in the treatment of the resident. If it were a regular practice to leave residents with fecal matter clinging to their skin, rather than promptly cleansing them, clearly this would constitute a deficiency. Under the circumstances here, however, the provider has proved that it was in substantial compliance with the requirements of 42 C.F.R. § 483.25(c) insofar as Resident 8 is concerned.