SUBJECT:

Batavia Nursing and Convalescent Center,

Petitioner,

Centers for Medicare & Medicaid

DECISION

Petitioner, Batavia Nursing and Convalescent Center, is a nursing facility certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the Centers for Medicare & Medicaid Services' (CMS) ⁽¹⁾ determination that, from August 6, 1999 through September 30, 1999, it was not in substantial compliance with program participation requirements and that the most serious deficiencies in the facility constituted actual harm that was not immediate jeopardy. For the reasons discussed below, I affirm CMS's determination to impose a civil money penalty (CMP) against Petitioner ($600 a day for a total of $33,600) for the deficiencies identified.

I. Background

The Ohio Department of Health (State survey agency) conducted an annual certification survey at Petitioner's facility from August 2, 1999 through August 6, 1999. The survey team (four of whom testified about this survey at the hearing -- registered nurses Debbie Truett, Sylvia Grimes, and Jacqueline Kardasz, and registered dietitian Sharon Dunn) determined that Petitioner was out of compliance with federal requirements for nursing homes participating in the Medicare and Medicaid programs. They found the most serious deficiencies to be isolated deficiencies that constituted actual harm that was not immediate jeopardy, where significant corrections were required (Level G deficiencies). These Level G deficiencies included four F Tags: F 157 (notification of rights and services); F 309 (receipt of highest practicable level of care); F 314 (pressure sores) and F 324 (accident prevention). The survey team also identified nine Level D deficiencies and one Level E deficiency. These were deficiencies that constituted no actual harm but had the potential for causing more than minimal harm that is not immediate jeopardy. ⁽²⁾ See CMS exhibit (CMS Ex.) 4.

From September 28, 1999 through September 29, 1999, the State survey agency revisited Petitioner's facility. The survey team (two of whom testified about this survey at the hearing -- Ms. Truett and Ms. Kardasz) found Petitioner still out of substantial compliance with participation requirements, with the most serious deficiency a repeat Level G deficiency at F 324 (accident prevention). The survey team also identified three level D deficiencies. See CMS Ex. 15.

On October 21, 1999, the State survey agency conducted another revisit which certified that Petitioner was in substantial compliance with participation requirements.

On October 28, 1999, CMS sent Petitioner a letter notifying it that, as a result of the survey findings, CMS was imposing certain remedies, including a CMP of $600 a day. On November 23, 1999, CMS sent Petitioner a letter notifying it that a second revisit had found it in substantial compliance and informing it that the total amount of the CMP due was $33,600 (for the period beginning on August 6, 1999 and continuing through September 30, 1999).

By letter dated December 23, 1999, Petitioner requested a hearing. The case was originally assigned to Administrative Law Judge Cynthia Josserand, reassigned to Administrative Law Judge Mimi Hwang Leahy, and finally reassigned to me. I held a hearing in the case from January 15 - 17, 2002. At the hearing I admitted into evidence CMS exhibits (CMS Exs.) 1 - 12, 15 - 46, and 53 - 58 (Transcript (Tr.) 22, 280) and Petitioner's exhibits (P. Exs.) 1 - 26 (Tr. 213, 279, 290). CMS submitted a brief (CMS Br.) to which Petitioner responded (P. Br.) and to which CMS replied (CMS R. Br.).

II. Issues

1. Whether Petitioner was out of substantial compliance with participation requirements between August 6 and September 30, 1999.

2. Whether the $33,600 CMP imposed by CMS against Petitioner is reasonable.

III. Statutory and Regulatory Background

The Social Security Act (Act) sets forth requirements for nursing facilities participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing nursing facilities participating in the Medicare program are found at 42 C.F.R. Parts 483, 488 and 489.

To participate in the Medicare program, a nursing facility must maintain substantial compliance with program requirements. To be in substantial compliance, a facility's deficiencies may pose no greater risk to resident health and safety than "the potential for causing minimal harm." 42 C.F.R. � 488.301.

If a facility is not in substantial compliance with program requirements, CMS has the authority to impose one or more of the enforcement remedies listed in 42 C.F.R. � 488.406, which include imposing a CMP. See Act, section 1819(h). CMS may impose a CMP for the number of days that the facility is not in substantial compliance with one or more program requirements, or for each instance that a facility is not in substantial compliance. 42 C.F.R. �� 488.430(a); 488.440.

In situations where deficiencies do not constitute immediate jeopardy, but have caused actual harm or have the potential for causing more than minimal harm, CMS may impose a CMP in the lower range of $50 to $3,000 per day. 42 C.F.R. � 488.438(a)(1)(ii).

IV. Burden of Proof

As an evidentiary matter, CMS must set forth a prima facie case that the facility was not in substantial compliance. Petitioner then has the burden of coming forward with evidence sufficient to establish the elements of any affirmative argument or defense, and bears the ultimate burden of persuasion. To prevail, Petitioner must prove, by a preponderance of the evidence, that it was in substantial compliance with relevant statutory and regulatory provisions. Meadow Wood Nursing Home, DAB No. 1841 (2002); Cross Creek Health Care Center, DAB No. 1611 (1998), applying Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd Hillman Rehabilitation Center v. HHS, No. 98-3789 (GEB), slip op. at 25 (D.N.J. May 13, 1999); see Coquina Center, DAB No. 1860, n.4 (2002). I follow this precedent in making my decision here.

V. Findings of Fact, Conclusions of Law, and Discussion

I make findings of fact and conclusions of law to support my decision in this case. I set forth each finding below, in italics, as a separate heading.

In making my findings in this case, I will be addressing solely the Level G deficiencies identified by the State survey agency surveyors and adopted by CMS. This is because I find these deficiencies alone are sufficient for me to uphold the CMP imposed against Petitioner by CMS.

1. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.10(b)(11) (F Tag 157 on the statement of deficiencies (CMS 2567 or 2567) dated August 6, 1999).

42 C.F.R. � 483.10(b)(11) is entitled "notification of changes" and provides, among other things, that a facility must immediately inform a resident's physician when there is a significant change in the resident's physical, mental, or psychosocial status.

CMS alleges that, based on surveyor observation, staff interviews, and a review of facility records, Petitioner failed to promptly notify two residents' physicians of changes in their health status. After reviewing the evidence and argument with regard to both residents, I find the deficiencies cited by CMS to be substantiated. I discuss each example by resident number.

Resident 102: This resident was readmitted to Petitioner's facility on July 22, 1999, following surgery for a small bowel obstruction. CMS Ex. 4, at 2 - 3; CMS Ex. 30, at 12; P. Ex. 12A, at 7; Tr. 153 - 155. On readmission, nursing notes indicate the dressing at the incision site was dry and intact (P. Ex. 12, at 36) and the resident's skin condition progress report noted the area looked "red" and that there was a small amount of yellow drainage. P. Ex. 12A, at 7. On July 23, 1999, "redness" was noted at the incision site. P. Ex. 12, at 36. However, on July 24, 1999, at 2:15 P.M., a large amount of foul green drainage was noticed at the site, and a supervisor was notified. P. Ex. 12, at 35; CMS Ex. 30, at 12. On July 25, 1999, at 2:15 P.M., a large amount of green drainage was again noticed. CMS Ex. 4, at 2; P. Ex. 12A, at 5; CMS Ex. 30, at 12. On July 26, 1999, at 3:00 P.M., a large amount of foul green drainage was noticed and the resident's physician was notified. P. Ex. 12A, at 6; CMS Ex. 4, at 3; CMS Ex. 30, at 12. At that time, the physician ordered an antibiotic and a culture of the drainage. P. Ex. 12A, at 6; P. Ex. 12, at 18; CMS Ex. 30, at 12; Tr. 153.

Ms. Grimes, a registered nurse and a State survey agency surveyor, credibly testified that green drainage and a foul odor can be indicative of an infection. Ms. Grimes testified that the resident's physician should have been notified on July 24, 1999, when the green drainage was first noticed by the nursing staff, and that the facility's failure to notify the resident's physician until July 26 did not represent prompt notification of the change in the resident's condition. Tr. 153 - 154. This is because, by the time the resident's physician was notified, there was a decline and deterioration in the resident's condition. Id. In fact, by July 26, the resident had become cyanotic and restless, and had to be admitted to the hospital. In the hospital the resident was diagnosed with a staph infection in the wound and blood. Tr. 154.

Petitioner's witness, Kimberly Parks, R.N. (who is employed as a regional director by Petitioner's corporate owner), also conducted a record review of this citation. She disagreed with the citation of the deficiency, asserting that the resident had drainage when the resident was re-admitted on July 22, 1999. Ms. Parks testified that the resident's physician was a physician at the hospital, so Petitioner believed that the physician was aware of the drainage because he gave an order for the resident to be on an antibiotic when she was readmitted to the facility on July 22. Ms. Parks testified also that, when the odor began in the drainage, Petitioner did notify the physician, but the resident refused to go back to the hospital and her daughter had to come and talk her into going back to the hospital. Thus, any delay in getting the alert and oriented resident to the hospital resulted from her presumably-competent refusal to go. Moreover, Ms. Parks testified that there was an order for a culture and sensitivity received for the resident prior to her going to the hospital, as well as an order for an antibiotic. Tr. 300 - 302, 314 - 315.

Petitioner's arguments do not support a finding that it was in compliance with this requirement. Petitioner does not address why the facility delayed in reporting the foul green drainage from when it was first noticed and reported to a supervisor on July 24 to July 26. Had the information on the change in this resident's condition been relayed to the physician on July 24, the actions the physician then took (ordering a culture and sensitivity and another antibiotic) might have prevented the severity of the infection and the need to send the resident to the hospital.

Resident 2: Resident 2 fell to the floor on July 24, 1999. P. Ex. 1, at 97. On July 25, Resident 2's physician ordered an x-ray of Resident 2's spine due to the resident's complaints of moderate to severe pain following the fall. P. Ex. 1, at 60. On July 26, Resident 2 fell again. ⁽³⁾ On July 26 also, the x-ray was obtained. P. Ex. 1, at 86. The x-ray results were incomplete, because the upper lumbar vertebra bodies could not adequately be visualized on the lateral view. The x-ray report recommended a non-portable film. CMS Ex. 30, at 20. However, Ms. Dunn, one of the State agency surveyors who testified, stated that her review of the records was silent as to whether Resident 2's physician was notified regarding the incomplete and visually deficient x-ray. Tr. 121. Ms. Dunn also observed the resident in pain during the days of the survey. Tr. 121 - 122. Contemporaneous nursing notes indicate that the resident was complaining of pain and receiving pain medication during this time. P. Ex. 1, at 85 - 87. My review of the nursing notes indicates that it was not until August 5 (the day before the survey was completed), that Resident 2's physician was notified of the problems with the x-ray and the resident's complaints of pain. P. Ex. 1, at 73.

CMS's argument is that Petitioner did not notify Resident 2's physician of the incomplete x-ray and, thus, the physician had no opportunity to accept or reject the recommendation for a non-portable film. Petitioner argues that there was no requirement that the resident's attending physician follow the radiologist's recommendation for a non-portable x-ray. P. Br. at 7. Petitioner argues that the resident was on pain medication and the facility was trying to rule out whether the resident (who was also on multiple psychotropic medications) was in actual pain or just manifesting psychosis and dementia. Petitioner also argues that the resident's physical condition explains why the x-ray was not clear. P. Br. at 21 - 22. Petitioner's arguments do not address the central issue: why the physician was not immediately notified of the incomplete x-ray so that the physician could then determine whether a non-portable film should be obtained, a deficiency which might have contributed to the resident's continuing experience of pain.

2. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.25 (F Tag 309 on the CMS 2567 dated August 6, 1999).

42 C.F.R. � 483.25, entitled "Quality of Care" provides 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."

CMS alleges that, based on observation, record review, and staff interview, Petitioner failed to ensure that the necessary care and services were provided to three residents in accordance with their comprehensive assessments. After reviewing the evidence and argument with regard to these residents, I find the deficiencies cited to be substantiated. I discuss each resident by resident number.

Resident 154: Petitioner does not really contest the facts as set forth in the 2567. P. Br. at 11 addressing CMS Ex. 4, at 11 - 15, see CMS Ex. 30, at 67 - 70. The 2567 reflects that Resident 154 was at risk for skin breakdown due to diagnoses including peripheral vascular disease, chronic edema and agitation. The resident was assessed as at risk for skin breakdown due to these diagnoses and to the resident's impaired cognitive status and need for assistance with activities of daily living, incontinence, and the use of physical and chemical restraints. The 2567 also reflects that both nursing notes and the observations of one of the surveyors (Ms. Truett) show that Petitioner failed to implement interventions consistent with the regulations to prevent a decline in the condition of Resident 154's feet.

The 2567 states that on July 11, 1999, nursing notes documented that the resident had edema of the left foot with a small purple area on the inner aspect of the left heel. On July 12, nursing notes documented that the resident bumps her feet on the wheelchair when moving about and slides her feet up and down in shoes. The surveyor does note that an immediate needs care plan was developed, but that it did not address protective and preventive interventions. On July 21, nursing notes documented that the area on the left inner heel was purple and 2 by 2 centimeters in diameter. On July 28, nursing notes documented the area as a large 3.4 centimeter blood filled blister that was raised 2 centimeters.

On August 2, the resident was observed by the surveyor physically restrained in a wheelchair, being pushed down the corridor by a staff member, wearing only socks on her feet, with both feet dragging on the floor under her chair. The resident's feet bent forward, with her toes rubbing against the floor. The surveyor notified a staff member, who removed the sock on the resident's left foot. The foot had pitting edema ("swelling that when one presses it with the fingertips . . . the depression caused by the pressing remains when the object that's doing the pressing is withdrawn . . ." (Tr. 43)) with a thin, transparent dressing on the heel and gauze tightly wrapped around the edematous ankle.

On August 3, the resident was observed physically restrained in her wheelchair wearing only socks on her feet. A nurse aide pushed her to her room with both her feet dragging on the floor. The resident then remained for approximately two hours in her wheelchair with both feet dragging on the floor. The resident was then observed with her feet bent forward under the chair. The resident was observed the same day during treatment to the left heel. The resident had a purple bruise on the top of her left great toe which had not been there the day before. On August 4, the resident was observed again, physically restrained in the wheelchair with both feet dragging on the floor. On August 5, the surveyor observed the resident during treatment to her left heel. The area was bloody at the outer aspects with dark black tissue. The sore was measured by the nurse at 4 by 4 centimeters. The 2567 reflects that nursing notes dated August 5 show that during treatment the blistered area ruptured with bloody brown drainage flowing from the wound. The 2567 notes that, during all the surveyor's observations, no interventions were put in place to prevent further decline and injury to the resident's feet, despite the observations having been shared with Petitioner's administrative staff on August 3 and August 5.

Ms. Truett testified that her review of the record did not show that a plan was developed as a result of Resident 154's assessment as at risk for skin breakdown. Instead, Petitioner identified that no plan would be developed. Tr. 40. Ms. Truett repeated the assertion in the 2567 that, although an immediate needs care plan was instituted, it did not address protective and preventive interventions. Ms. Truett testified that such interventions were warranted because the facility had identified that Resident 154 bumped her feet on the wheelchair and slid her feet up and down in shoes, which actions could have led to injury to her foot. Moreover, Ms. Truett testified that the condition of Resident 154's heel had worsened, going from a 2 by 2 centimeter purple area on July 21 to a larger blood filled blister on July 28, indicating more damage underneath the skin. Tr. 42.

Petitioner did not dispute either the description of the nursing notes or the observations of Ms. Truett as contained in the 2567, except as the description or observation concerned the gauze wrapped about Resident 154's leg. P. Br. at 5. Instead, Petitioner referred to the testimony of Tamela Lewis, R.N., who has been employed for 10 years at Petitioner's facility and is responsible for preparing patient assessments and care plans. Petitioner refers to Ms. Lewis' testimony that she examined Resident 154's medical records and saw that there was a July 12 physician's order to clean the inner heel of the left foot with normal saline and to apply a hydrofluoric dressing to the heel, which was to be checked every day for placement and changed every five days. Tr. 221.

Ms. Lewis also testified that there was an active care plan for the resident, and that the interventions regarding the care and treatment of the resident's skin included that the resident was turned every two hours, had heel protectors, and a special bed mattress. Ms. Lewis testified that the resident frequently kicked off the heel pads, which made it hard to keep them on, but that the resident wore them in bed. Tr. 221 - 222.

None of Ms. Lewis' observations, however, address CMS's deficiency citation here - that the resident was assessed as at risk for skin breakdown, had skin breakdown identified, had skin breakdown that was getting worse on the left heel, and yet no adequate care plan was developed to address the bumping, sliding of the feet up and down in shoes, and foot dragging that both nursing notes and the surveyor's observations identified.

Ms. Truett specifically testified that the lack of protective and preventive interventions in Petitioner's immediate needs care plan could lead to injury to the foot (Tr. 41) and, in fact, the condition of Resident 154's foot did get worse.

Resident 186: The 2567 indicates that this resident had diagnoses including cerebral vascular accident, hypertension, and heart disease. The resident had a physician's order for use of an anti-coagulant medication routinely until July 23, when it was discontinued due to an elevated bleeding time and excessive bleeding at an injury site. The resident also had a physician's order for bilateral knee high anti-embolism hose to be on at all times.

However, on August 2 from 12:20 P.M. to 2:00 P.M., on August 3 from 7:20 A.M. to 10:45 A.M. and at 12:15 P.M., and on August 6 at 7:42 A.M., Resident 186 was observed seated in a regular chair with his lower extremities dependent on the floor. At no time was he wearing the anti-embolism hose. CMS Ex. 4, at 14 - 15; CMS Ex. 30, at 87 - 88.

Ms. Truett testified that anti-embolism hose are usually implemented for patients who are at risk for deep vein thrombosis or blood clots that may occlude the lower extremities. Anti-embolism hose also aid in preventing blood clots, as did the anti-coagulant medication which had to be discontinued. Tr. 44 - 46. Ms. Truett noted that the deficient nursing practice here was that while the resident's physician ordered the application of the anti-embolism hose, the facility's staff failed to implement the physician's order. Tr. 47.

Petitioner's argument is that Ms. Truett also acknowledged that in spite of the order for the hose, it would not be inappropriate for the staff to remove them and that there were exceptions to the order. Tr. 91. Petitioner argues that Ms. Truett made no investigation of the facility's protocols and practices regarding the application of such hose. Tr. 92.

I find that it is not the surveyor's responsibility to determine whether there was a facility protocol or practice for dealing with anti-embolism hose. The surveyor noted here that a physician's order was not followed in numerous instances in a situation where the order was for hose to prevent deep vein thrombosis or blood clots. It was up to the facility to show that it was in compliance with the orders. In this case, Petitioner's failure to follow the physician's order could have led to serious, even fatal, consequences for the resident.

Resident 39: Petitioner does not dispute the facts as set forth in the 2567 with regard to this resident. Resident 39 had diagnoses including peripheral vascular disease, hypertension, and right hip fracture. CMS Ex. 4, at 15; CMS Ex. 15, at 41; CMS Ex. 30, at 33; Tr. 47. The resident was assessed on May 28, 1999, with limited range of motion in the lower extremities. The resident had current physician's orders for bilateral thigh high anti-embolism hose on at all times (which the physician ordered could be removed daily only for hygiene and then were to be re-applied (see P. Ex. 4, at 47, 48)). However, Ms. Truett observed the resident on August 2, 1999, from 1:15 P.M. to 4:35 P.M., on August 3, from 7:23 A.M. to 10:10 A.M., and from 12:18 P.M. to 4:05 P.M., and on August 4 from 7:30 A.M. to 10:45 A.M. and at 12:45 P.M., either in bed or in a wheelchair, without the physician ordered anti-embolism hose on. CMS Ex. 4, at 15; Tr. 48. Ms. Truett testified that the facility was engaging in a deficient nursing practice here, because the physician ordered the hose to be on at all times and the facility failed to implement the physician's order. I agree. Moreover, I agree with CMS that even if Resident 39 resisted wearing anti-embolism hose, the facility should have informed her physician so that the physician could have given different orders to control her peripheral vascular disease. CMS R. Br. at 17.

3. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.25(c) (F Tag 314 on the CMS 2567 dated August 6, 1999).

The regulation at 42 C.F.R. � 483.25(c) provides that, based on a comprehensive assessment of a resident, a facility must ensure 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, and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

Here, CMS alleges that based on record review, observations, and staff interview, Petitioner failed to ensure that a resident having a pressure sore received the necessary treatment and services to promote healing.

Resident 169: Petitioner has not submitted evidence contradicting the material facts as set forth in the CMS 2567 and as testified to by Ms. Truett. CMS Ex. 4, at 17 - 18; Tr. 35 - 39. Resident 169 had diagnosis including diabetes, cerebral vascular accident, and thyroid disease. CMS Ex. 4, at 17; CMS Ex. 30, at 1; Tr. 35. The 2567 notes that on May 10, 1999, the resident was assessed as at risk for skin breakdown with a history of an open pressure sore on her right heel. On July 13, 1999, at 6:45 A.M., nursing notes document that the resident had a nickel sized open stage II pressure sore on her right heel. ⁽⁴⁾ The sore was described as thick white in appearance with a 0.5 centimeter open area in the center and reddened surrounding tissue. A skin treatment summary dated July 13 identified that the resident had new shoes brought in by her family and that they would be left off until the sore healed. Ms. Truett verified this with the administrative staff on August 3. The facility's care plan interventions included heel pads on the resident when she was in bed and a foot cushion on her wheelchair foot rest. On August 2, 1999, from 12:35 P.M. to 3:35 P.M., Ms. Truett observed the resident in bed without the planned heel pads on her feet. On August 3, from 8:20 A.M. to 9:03 A.M., Ms. Truett observed the resident wearing tennis shoes and sitting in her wheelchair with her feet resting on the foot rests. On August 4, from 7:30 A.M. to 8:30 A.M., Ms. Truett observed the resident sitting in her wheelchair with her feet on the foot rests and tennis shoes on. On August 4 also, at 1:03 P.M., Ms. Truett observed treatment of the resident's right heel. It was measured by the staff nurse at 2.3 by 3 centimeters with an outer edge of white tissue surrounded by deep red tissue. The heel had open yellow Stage II areas that measured 2 centimeters by .6 centimeters. On August 4, nursing notes documented that the sore had brown drainage with a black area at the sore site. On August 6, at 7:40 A.M., Ms. Truett observed the resident in bed without foot pads on. A nurse aide exited the room without applying the foot pads. CMS Ex. 4, at 17 - 18; Tr. 35 - 39.

Ms. Truett testified that the failure to implement the planned interventions (that the resident was in bed without heel pads, was wearing tennis shoes and sitting in a wheelchair with her feet resting directly on the footrest of her wheelchair) risked further deterioration in the open sore identified by facility documentation. Tr. 36 - 37. CMS argues that the failure to implement the planned interventions (the heel pads and the foot cushion) allowed further decline in Resident 169's skin breakdown and that Petitioner thus failed to ensure that Resident 169 received the necessary treatment and services to promote healing of a pressure sore. CMS. Br. at 10 - 12.

Petitioner argues that Resident 169's medical diagnosis and condition contributed to her skin breakdown because she had both circulation problems and was diabetic. Petitioner asserts that the interventions applied by it to prevent pressure sores included a turn schedule, daily checks by aides when care was provided, an eggcrate mattress, heel pads, elevation of the heels, regular lab work to evaluate her blood, and dietary involvement including nutritional health supplements fortified with vitamins. P. Br. at 20. Petitioner asserts that Resident 169 was noncompliant and would refuse to walk, to eat, to adhere to a turn schedule, and would kick off her heel pads. Petitioner asserts that it discussed with her physician changing from heel pads to gauze pads. Petitioner also argues that Resident 169 did not in fact have a Stage IV pressure sore, but that it was identified as such because it was black. Petitioner also obliquely attacks the extent of Ms. Truett's observations, arguing that she had a "propensity to play word games" because it took two pages of cross-examination for her to acknowledge that Resident 169 was on a pressure reducing mattress and that she only admitted on cross-examination that she documented Resident 169 wearing socks. P. Br. at 4.

Even if I accept all Petitioner's arguments and assertions to be true, however, I still find Petitioner out of compliance with this participation requirement. Moreover, I find actual harm to have existed, in that Resident 169 developed a pressure sore which steadily became larger. Petitioner has not contested that its own care plan to prevent pressure sores for Resident 169 included heel protectors and a foot cushion, nor has it contested the surveyor's observations that Petitioner was not consistently implementing the care plan with regard to heel protectors and a foot cushion. I agree with Ms. Truett that Petitioner identified Resident 169 as at risk and then did not implement its planned intervention to prevent the deterioration of the pressure sore once it developed. Tr. 39. Petitioner's actions are thus not consistent with the requirement that it prevent avoidable pressure sores and provide necessary treatment and services to promote healing in an existing pressure sore.

4. As of the survey ending on August 6, 1999, Petitioner was out of compliance with the participation requirement at 42 C.F.R. � 483.25(h)(2) (F Tag 324 on the CMS 2567 dated August 6, 1999).

The regulation at 42 C.F.R. � 483.25(h)(2) provides that a facility must ensure that each resident receives adequate supervision and assistance devices to prevent accidents. This requirement does not amount to strict liability or require absolute success in an obviously difficult task. Using an outcome-oriented approach, facilities have flexibility to use a variety of methods and approaches, but they are responsible for achieving the required results. In ensuring adequate supervision, the facility is not required to do the impossible or be a guarantor against unforeseeable occurrence, but it "is required to do everything in its power to prevent accidents." Koester Pavilion, DAB No. 1750, at 24 (2000); Woodstock Care Center, DAB No. 1726, at 25 (2000).

Here, CMS alleges that, based on observation, record review, and staff interview, Petitioner failed to ensure that four residents received adequate supervision and assistance devices to prevent accidents. After reviewing the evidence and argument with regard to these residents, I find the deficiencies cited to be substantiated. As above, I discuss each example by resident number.

Resident 39: Petitioner does not contest the facts as set forth in the 2567 dated August 6, 1999, but does contest that a deficiency should have been cited based on the facts. CMS Ex. 4, at 23 - 26; Tr. 249. Resident 39 (discussed above at Finding 2) had diagnoses including severe dementia, Alzheimer's disease, and hip fracture. Resident 39 was assessed to require extensive physical assistance for all care and had memory impairment and poor decision making ability.

Resident 39 was assessed as at risk for falls and had a history of falls. On October 1, 1998, at 12:45 A.M., nursing notes show a nurse aide found Resident 39 on the floor beside her bed. She sustained a bruised left hand and a laceration over her left eye. She required transfer and treatment at a hospital. She was readmitted to the facility on the same date and documentation identifies that she had continued complaints of left hip pain and refusal to bear weight. Prior to the fall she was ambulatory. On October 22, 1998, she was diagnosed as having a non-displaced right hip fracture. On November 8, 1998, nursing notes document that she fell out of bed and was found on the floor with a skin tear on her left elbow. Nursing notes document that on May 19, 1999, at 7:00 P.M., on May 23, 1999, at 1:30 P.M., and on May 27, 1999, at 10:20 A.M., Resident 39 climbed out of bed and was found on the floor. She sustained injuries including swelling, bruising, redness, and abrasions. CMS alleges that Resident 39 remained at risk from falls from her bed and her clinical record is silent with regard to preventive interventions. CMS Ex. 4, at 23 - 24.

On August 2, 1999, Ms. Truett observed Resident 39 from 1:15 to 4:34 P.M., in bed, with full unpadded side-rails raised at the head of the bed. There was no personal alarm on her, or on the bed, and she was leaning against the unpadded side-rail on the right and placing her arms through and over the side-rail bars and reaching and pulling on the privacy curtains between the beds. Ms. Truett described Resident 39 as agitated, moving her legs over the side-rail, and thrashing about in bed. CMS Ex. 4, at 24 - 25; CMS Ex. 34, at 137; Tr. 50. Ms. Truett testified that the unpadded side-rails posed a problem because of the potential for side-rail entrapment. Tr. 50. On August 3, 1999, Ms. Truett observed Resident 39 in bed, with a personal alarm device lying on the bed next to her. The alarm device was not attached to anything and moved with the resident without activating. The resident was moving about in bed, with her head lying on the right unpadded side-rail. At 12:52 P.M., Ms. Truett observed that both the resident's shins were bruised and there was an inflamed scabbed area on her right ankle. The clinical record and facility staff, when interviewed, failed to identify the cause of the injuries. On August 4, 1999, Ms. Truett observed the resident in bed, turned to the right, with her legs over the bottom of the side-rails and her head on the raised right side-rail bar. CMS Ex. 4, at 24 - 25; CMS Ex. 34, at 34, 135; Tr. 51 - 52.

Ms. Truett also found that Resident 39 engaged in various troublesome and unsanitary behaviors which the facility failed to provide the necessary preventive measures for. On May 25, 1999, at 1:30 P.M., Resident 39 was found with a bottle of "Phisohex" open and in her mouth. Resident 39 obtained the bottle from the top of the treatment cart. On June 1, 1999, at 6:00 P.M., Resident 39 entered a male resident's room and drank from his urinal. On June 28, 1999, at 9:30 A.M., Resident 39 grabbed a cord for a stereo in the dining room and pulled it off on herself, sustaining a 2 centimeter bruise on her right shin. CMS asserts that neither Resident 39's clinical record or her care plan addressed her need for increased supervision and prevention and protective interventions to ensure that she did not injure herself. CMS Ex. 4, at 25 - 26; CMS Ex. 30, at 34A and B; Tr. 53 - 54.

Petitioner presented the testimony of Mary Palmer, a licensed nursing home administrator and Petitioner's administrator from March 2000 through September 2001. Ms. Palmer testified that she did not believe the citation with regard to Resident 39 was accurate. She testified that Resident 39 was a small woman who was frequently agitated in bed, leading to a tendency to bruise. She also testified that the bruises on August 3 could have been caused by another resident who wheeled in front of Resident 39, hitting her legs. She testified that Resident 39 threw objects out of her room and went in and out of other residents' rooms and was not easily redirected by staff. Moreover, Resident 39 resisted care on a daily basis. Ms. Palmer testified that Resident 39's behavior could not be easily altered. Tr. 249 - 252. Ms. Palmer also testified that Petitioner would try different interventions for residents who resisted care and, if they didn't work, would try something else. However, Ms. Palmer did not have information regarding Petitioner's interventions with respect to Resident 39 because she had not reviewed the resident's chart. Tr. 253 - 254. LPN Rebecca Vincent, Petitioner's ancillary administrative nurse, who oversaw and monitored the residents receiving psychoactive medications or who had restraints, testified with respect to Resident 39's falls. She stated that Resident 39 was assessed following any fall with interventions put in place after each. She noted that at one point Resident 39 went without a fall for six months and that, following the subsequent fall, there was an assessment by a nurse, completion of an incident report, and an immediate care plan. Moreover, she stated that the facility's practice is not to pad rails when only half-rails are in place: half-rails are only to enable a resident to turn and reposition in bed. She also testified that with respect to Resident 39's going into another resident's room and drinking urine, there was no way to care-plan for that. Tr. 264 - 268.

The gravamen of CMS's case here is that Petitioner did not provide Resident 39 adequate supervision and assistance devices to prevent accidents, in that it did not properly address in her clinical record or care plan the need for increased supervision and prevention and identify protective interventions to ensure that she did not injure herself. While Petitioner's witnesses asserted that they care planned and provided interventions, neither Petitioner nor its witnesses provided citations to documentation existing prior to the survey to substantiate these assertions. Petitioner has not rebutted the prima facie case set forth by CMS.

Resident 164: CMS asserts here that Petitioner properly assessed Resident 164 for falls, and recommended interventions, but that actual evidence failed to reveal consistent implementation of the interventions recommended. CMS Br. at 16; Tr. 59.

The 2567 reflects that Resident 164 had diagnoses including Parkinson's disease, arthritis, Alzheimer's disease with agitation, anxiety, and insomnia. It reflects that the clinical record indicated that the resident had a history of falls to the floor. On August 24, 1999, the resident was assessed as at risk for falls due to a history of falls, cognitive impairment, difficulty with bed mobility and transfers, weakness, balance problems, poor leg control, and visual impairment. A fall prevention care plan had interventions for providing a call light within reach, a pad on the floor beside the bed, and a personal alarm at all times. CMS Ex. 4, at 26. Petitioner does not contest these facts. See P. Br. at 16 - 17.

The 2567 then reflects that Resident 164 sustained a series of falls. On February 28, 1999, nursing notes document that Resident 164 was found with half his body on the floor and the other half on the mat beside his bed. On April 22, 1999 nursing notes document that he was found on the floor next to his bed. On July 20, 1999, nursing notes document that he was found on the floor beside his bed with his head lying on the floor. On July 30, 1999, nursing notes document that he was found on the floor by his bed with a six to seven inch scrape on his right inner elbow and red areas on both his hips. The clinical record did not document whether his call light was in reach or whether his personal alarm was in use at the time of these falls. CMS Ex. 4, at 26 - 27; CMS Ex. 30, at 78; Tr. 55.

Ms. Truett observed Resident 164 at several times during the survey. Tr. 56 - 60; CMS Ex. 4, at 27. On August 4, 1999, at 8:30 A.M., Ms. Truett observed Resident 164 alone in his room lying on his bed at the very right edge of his mattress. The left side-rail was raised and the right side-rail was lowered with his call light lying on his night stand out of his reach. A personal alarm device was lying on the bed next to him at the edge of the mattress. Ms. Truett testified that the alarm would not have sounded even if he fell out of bed. Tr. 57. Ms. Truett also observed that the pad on the floor next to his bed was positioned so that half of it was under the bed. Moreover, it did not extend to the head or the foot of the bed. Due to the positioning of the mat, a large area of bare floor was observed from the resident's shoulder areas and at the foot of the bed. At 9:00 A.M., Ms. Truett observed the resident in the same position, with the improper placement of the pad, personal alarm, and call light. Ms. Truett shared her concerns with the staff to avoid another accident with possible injuries. At 12:50 P.M., Ms. Truett observed Resident 164 in a wheelchair at his bedside, with the call light laying on his night stand behind his back. Ms. Truett also noted during the survey that Resident 164's wife visited him at the facility everyday until between "2&3". CMS Ex. 34, at 134.

Petitioner does not deny that it created the interventions, nor does it assert that it consistently implemented them. See P. Br. at 16 - 17. Instead, Petitioner, through the testimony of Ms. Vincent, argues that Resident 164's wife essentially subverted these interventions: she came in daily at 6:00 A.M., pushed the mat out of the way to get close to his bed, and moved the call light out of his reach because she was with him most of the time. Further, she always requested the rails to be down because she was next to him. Tr. 262. Moreover, Ms. Vincent testified that Resident 164 had a history of falling and putting himself on the floor as an attention seeking behavior. Tr. 262 - 263. Finally, Ms. Vincent noted that it is simply standard nursing procedure to place a call light within a resident's reach and nursing notes would not document it. Tr. 263 - 264.

As stated above, the gravamen of CMS's position is that Petitioner failed to consistently implement the interventions it recommended. Petitioner's arguments, as explained in Ms. Vincent's testimony, do not address this concern. If Petitioner knew that Resident 164's wife was subverting the interventions it assessed to be necessary for his safety, it was up to Petitioner to make sure that they were implemented - and certainly to make sure that they were implemented while the resident's wife was not in the room. Moreover, stating that Resident 164's falls were part of an attention seeking behavior does not excuse the facility from implementing the interventions it assessed as necessary to address the resident's falls - or care planning for what to do to address his attention seeking behavior. Finally, Petitioner does not address why the call light was not in place during Ms. Truett's observations. Petitioner has not rebutted the prima facie case put forth by CMS.

Resident 7: Here CMS is arguing that Petitioner failed to ensure that Resident 7 received adequate supervision and evaluation of a restraint assistance device to prevent accidents; specifically that the facility erred in using a soft waist restraint for Resident 7 because she made active attempts to remove the restraint. CMS Ex. 4, at 29; Tr. 127 - 128.

The 2567 and the testimony of Sharon Dunn, a surveyor with the State survey agency for over 15 years, who has a bachelor of science degree in food and nutrition (Tr. 19 - 120), reflect that Ms. Dunn observed Resident 7 in a cloth waist restraint (either in bed or in a wheelchair) on all five days of the survey ending on August 6, 1999. ⁽⁵⁾ Nursing notes record that on July 5, 1999, Resident 7 was found lying on the floor on her left side with her wheelchair on her. Resident 7 had a soft waist restraint in place which remained in place and was untied by staff. As a result of this incident, Resident 7 sustained a laceration to her forehead and complained of pain. Resident 7 was sent to the hospital and returned with 16 stitches. No changes were made to her plan of care to prevent further injury. Ms. Dunn's record review showed that the restraint was ordered on December 21, 1999. The order specified that a soft waist device be on her at all times (wheelchair and bed) to remind her to ask for assistance with transfers due to her diagnosis of dementia with agitation and history of significant falls. The manufacturer's instructions for the waist restraint stated that it was not intended for patients who actively attempted to remove it. The instructions also stated to make sure that the bed-rails were in the raised position before leaving a resident. Ms. Dunn's review of nursing notes and physician's orders showed that Resident 7 was restrained with the soft waist restraint with the use of two half side-rails from December 21, 1998 through August 3, 1999, leaving a potential for injury. Also, Resident 7's side-rail safety assessments of December 4, 1998 and March 11, 1999, for the use of two top half side-rails, indicated that the resident was at risk for going over the side-rails or off the end of the bed. Resident 7's clinical record showed that she made active attempts to remove the device, contrary to the manufacturer's instructions. Nursing notes of July 17 and 20, 1999, stated that she was resistant to wearing the restraint, agitated, and swinging her arms when staff tried to reapply it. A nursing note on July 16, 1999, indicated that Resident 7 removed a butter knife from the dining room and took it to her room to cut off the restraint. Ms. Dunn observed Resident 7 in the soft waist restraint during the days of the survey. On August 4, 1999, Resident 7 stated to Ms. Dunn that she did not like having the restraint on and asked her to assist in removing it. CMS Ex. 4, at 27 - 29; Tr. 124 - 128.

Ms. Dunn testified that she did not believe the facility provided adequate care for Resident 7. This was because the manufacturer's instructions specified that the restraint was not indicated for a resident who tries to remove it, and there was documentation in Resident 7's clinical record that she had tried to remove the restraint and was agitated with it on. Ms. Dunn also testified that Resident 7's side-rail assessment stated that she was at risk for climbing out of bed with the half side-rails up. She testified that to have the restraint on with Resident 7 making active attempts to either release the restraints or get out of bed left her at risk for further injuries similar to the incident of July 5, 1999. Tr. 128.

Petitioner does not directly contest Ms. Dunn's observations or her review of the clinical record, noting simply that Ms. Dunn testified that the facility was acting fully in compliance with physician's orders. P. Br. at 7. In opposition to CMS's citation of the deficiency here, Petitioner offers the testimony of Ms. Vincent, who opines that Resident 7 was a difficult management problem. Ms. Vincent also asserts that Resident 7 was assessed and changes were made in her care plan from "July to November." However, Ms. Vincent did not state the year these changes were implemented, and, if the implementations took place in 1999, anything the facility did following the survey ending on August 6 is immaterial. If the year was 1998, the facility's actions did not reflect the state of the facility during the survey. Additionally, according to Ms. Vincent, the purpose of the changes was to attempt to keep Resident 7 safe while maintaining her highest level of functional ability. Ms. Vincent testified that this balancing took into account the psychosocial, emotional and physical aspects of keeping Resident 7 safe, and included consideration of the family's feelings and concerns and the physician's opinion. Ms. Vincent opinion is that "You don't automatically want to change devices if there's another problem that you can deal with and perhaps go back to or stay with a device that currently is working." Tr. 272 - 274. ⁽⁶⁾

Ms. Vincent's testimony and Petitioner's argument do not adequately address CMS's concerns, which go to the use of the waist restraint in contravention of the manufacturer's instructions and the possibility that, unsupervised, and unwilling to wear the waist restraints, Resident 7 was at risk for accidents.

Resident 41: The 2567 reflects that Resident 41 was a cognitively impaired resident with a history of falls. He had physician's orders for a cloth waist restraint to be on at all times to remind him to request assistance with transfers due to his decreased cognitive status, and for his side-rails to be up at all times as he was unable to ambulate without assistance due to Alzheimer's with cognitive impairment. The 2567 reflects that the manufacturer's instructions for the soft waist restraint state that staff should "[a]lways make certain that the bed rails are in the raised position before leaving patient." CMS Ex. 4, at 29 - 30; CMS Ex. 58; CMS Ex. 39, at 17.

Ms. Dunn observed Resident 41 at 9:15A.M. and at 4:44 P.M. on August 2. Resident 41 was alone in his room, restrained in bed with the soft waist restraint in place. The bottom portion of the left padded side-rail was not raised completely or locked in place. When slight pressure was put on it the side-rail lowered. Ms. Dunn informed Kim Parks of Petitioner's staff of this, and Ms. Parks raised the side-rail and locked it into position. On August 5, at 9:41 A.M., Ms. Dunn observed Resident 41 in his room, alone, seated in his wheelchair, with the right side of the restraint not tied. Ms. Dunn testified that Resident 41 was at risk for falls, because he had a history of trying to get up and ambulate unassisted without the restraint being tied. The purpose of the restraint was to remind him that he could fall. Ms. Dunn made staff aware of the untied restraint and it was re-tied.

Ms. Dunn's record review showed that on May 7, 1999, Resident 41 had a restraint assessment that stated the restraint was in use due to decreased cognitive status, ambulating without assistance, climbing out of bed, and degenerative dementia with agitation. On May 21, 1999, at 12:30 P.M., Resident 41 was apparently found sitting on the floor in front of his wheelchair with his restraint untied. CMS Ex. 3, at 29 - 30; Tr. 129 - 133.

Petitioner argues that the statement of deficiencies is not accurate with regard to the manufacturer's recommendations. In defense of this argument, Petitioner offered the testimony of Ms. Vincent. Ms. Vincent testified that she is familiar with Resident 41, his records, his restraints, and the manufacturer's recommendations regarding the use of side-rails and restraints. Ms. Vincent testified that Ms. Dunn's testimony regarding the device not being recommended for use by a resident who attempts to remove the restraint isn't in the manufacturer's recommendations and referenced what was later identified as P. Ex. 26. Ms. Vincent also testified that Resident 41's family never complained about his care. Further, Ms. Vincent testified that Resident 41 had an order for a restraint in his wheelchair to use as a reminder to get assistance when he wanted to ambulate. She testified that Resident 41 could and did untie the restraint. She testified that the facility evaluated potentially changing the restraint, but that the change required the approval of his physician and the consent of the resident's responsible decision-maker. Tr. 269 - 270.

Petitioner's arguments are unavailing. I agree with CMS in this case that Ms. Vincent's testimony does not rebut the allegations in the 2567 that Resident 41's side-rails were not in place or that Resident 41's restraint was untied on August 5. Furthermore, Petitioner has provided no explanation for why it offered a different set of manufacturer's recommendations than those contained in Resident 41's clinical record. I also agree with CMS that whether a resident's relative complains about a particular resident's care or not is not the standard for compliance with the requirements. Finally, it was up to the facility to inform the physician and responsible decision-maker that Resident 41 was at risk for falls, and there is no evidence that the facility ever did so.

5. As of the revisit survey ending on September 29, 1999, Petitioner remained out of compliance with the participation requirement at 42 C.F.R. � 483.25(h)(2) (F Tag 324 on the CMS 2567 dated September 29, 1999).

Here, CMS alleges that based on observation, record review, and staff interview, the facility continued to fail to ensure that residents received adequate supervision and assistance devices to prevent accidents. After reviewing the evidence and argument with regard to the three residents cited in the 2567 (CMS Ex. 15, at 7 - 12) I find the deficiencies cited to be substantiated at Level G. As above, I discuss each example by resident number.

Resident 61: CMS determined that Petitioner was out of compliance with the participation requirement because Petitioner did not implement different or additional interventions to supervise and minimize Resident 61's fall risk.

The 2567 (CMS Ex. 15, at 7 - 9) reflects that Resident 61 was admitted to the facility on August 20, 1999, with diagnoses including dementia, confusion, neurogenic bladder, degenerative joint disease, and osteoarthritis. Documentation in the clinical record indicates that prior to admission the resident was hospitalized due to severe confusion. On August 20, the resident was assessed with short and long term memory impairment, poor decision making ability and the need for physical assistance with transfers and ambulation. On August 21, nursing notes document that the resident was found on the floor. On August 23, nursing notes document the resident was found sitting on the floor. Facility interventions implemented as a result of these falls were to encourage the resident to use a walker for ambulation and to request a physical therapy evaluation, after which the resident started on physical therapy. On September 1, the resident was found on the floor at the foot of her bed with complaints of pain in the left shoulder and hip. On September 2, nursing notes document the resident fell backwards and hit her head on a heater. The resident sustained a laceration to the right temporal area, bruising on a hip and arm, and a skin tear on an elbow. Nursing notes document that the resident was re-educated about the use of the walker and a restraint free alarm was initiated. On September 6, nursing notes document the resident was found sitting on the floor in front of her recliner. The alarm was in her hand. On September 8, the resident was found on the floor in front of her chair. Undated nursing notes document that the resident was again found on the floor. A physical restraint was initiated on September 9, but it was discontinued on September 20. Although the physical restraint was discontinued, the restraint free alarm was continued. On September 27, nursing notes document that the resident was found on the floor in another resident's room. The restraint free alarm did not sound as it was still in the resident's bed. On September 28, Ms. Truett observed Resident 61 from 9:52 A.M. to 10:40 A.M., and from 2:00 P.M. to 4:00 P.M., seated in a recliner chair in her bedroom. The resident stated to Ms. Truett that she was bored and tired of sitting alone in the bedroom. She complained of having nothing to do and not being able to get around because of the restraint free alarm. On September 29 from 8:30 A.M. to 9:47 A.M., Ms. Truett observed Resident 61 again. The resident complained again about having nothing to do and stated and demonstrated that she had the ability to remove and replace the restraint free alarm. She stated to Ms. Truett, "[T]hey think by placing it on the back of my shirt that I can't reach it but I can." CMS Ex. 15, at 7 - 9; Tr. 62 - 66.

Petitioner does not object to most all of the facts CMS cited in the 2567. Instead, Petitioner asserts that Ms. Truett's testimony regarding Resident 61 being bored with activities defies logic. Specifically, Petitioner argues that while Ms. Truett acknowledged Resident 61 had some degree of dementia, she did not know to what degree or whether the resident could tell good from bad, pain from pleasure, or hot from cold. P. Br. at 5. Petitioner also presented the testimony of Ms. Vincent. Ms. Vincent asserts that the description of Resident 61 in the 2567 is inaccurate. Ms. Vincent asserts that the resident did not sit in a room and act bored. Instead, she was one of a threesome that sat at a certain intersection in the hallway and critiqued people. The three looked out for each other. Ms. Vincent further testified that Resident 61 is an outgoing person who enjoys talking to people and spends very little time in her room. CMS Br. at 19.

Petitioner's arguments and assertions do not address the central issue of the case: why the facility did not implement a different intervention or device to prevent or minimize falls. Petitioner has not rebutted the prima facie case put forward by CMS.

Resident 81: CMS asserts that during interviews administrative nursing staff identified that the facility policy was to assess residents for falls within 14 days. CMS asserts that Resident 81 had repeated falls and was at risk for falls without adequate interventions implemented to minimize the fall risk. CMS Ex. 15, at 10.

The 2567 (CMS Ex. 15, at 9 - 10; see Tr. 66 - 71) reflects that Resident 81 had diagnoses including herniated disk, dizziness, syncope, frequent falls, and hypertension. A hospital note on August 9, 1999, identified that the resident complained of lower back pain and asserted that every time she got up her legs would not hold her and falls occurred. On August 19, at 1:30 A.M., nursing notes documented that she was found on the bathroom floor. On August 31, she was assessed to require only supervision with transfers and ambulation. A care plan for falls was written on September 1. Care plan interventions included ensuring that her call light was within reach at all times and that her siderails were up on the right side due to her generalized weakness. On September 24, at 4:00 P.M., nursing notes documented that she was found on the floor at her bedside. On September 28, at 2:00 A.M., nursing notes documented she was found on the floor yelling loudly. She was noted to have increased confusion at this time. The clinical record was silent as to comprehensive interventions to minimize her risk for further falls and the potential for injury.

On September 28, at 4:03 P.M., Ms. Truett observed the resident in bed without the right siderail raised. The resident was "scooted" down in the bed and the call light cord was above her head and tucked under the pillow out of ther reach. On September 29, from 7:10 A.M. to 9:50 A.M., and at 12:55 P.M., the resident was observed lying in bed on her back. At 7:10 A.M. the call light cord was observed tucked under her pillow out of her reach. During this observation period, the head of her bed was elevated and she was observed "scooted" down in the bed and lying on the left edge of her mattress.

Ms. Truett testified that the interventions planned, other than the call light, did not meet the resident's needs. She had documented weakness, her legs could give out, and she was unable to be independent, yet the interventions planned by Petitioner did not address these issues. Tr. 69. Ms. Truett noted that with the call light under the pillow the resident couldn't see it or obtain it should she need assistance. Moreover, Ms. Truett testified Petitioner's policy to wait 14 days to assess a resident for falls was inappropriate given the potential for injury. Tr. 69 - 70.

Petitioner asserts that Ms. Truett could not identify what effective interventions would be for the prevention of accidents. Petitioner also asserts that when nursing notes state a resident is "found on the floor" that does not necessarily mean that a resident fell. Petitioner also states that Ms. Truett cannot say when the siderail she observed not to be raised, on September 28 at 4:03 P.M., was actually lowered or raised. Petitioner asserts that this resident had a diagnosis of syncope, which is generally characterized as an unannounced, unpredicted loss of balance and falling down. Petitioner asserts that syncope is not caused by a facility, nor is it something a facility can prevent. Petitioner asserts that only where a significant risk of injury to a resident's health or safety exists can a facility intervene with medications administration in the absence of an attending physician order. Finally, Petitioner asserts that for all residents identified as being found on the floor there was no way to tell if these were syncopic episodes. P. Br. at 5- 6; see Tr. 101 - 106.

Petitioner's assertions and argument miss the point. CMS is asserting that Petitioner did not timely assess and implement interventions to prevent falls. It was not the surveyor's duty to identify effective interventions. This was a resident with syncope who complained that her legs would not hold her up. It was Petitioner's responsibility to effectively care plan for this. CMS has made a prima facie case which is unrebutted by Petitioner.

Resident 161: CMS determined that Petitioner failed to implement an immediate needs care plan with comprehensive interventions to address this resident's falls.

The 2567 (CMS Ex. 15 at 10 - 11; see Tr. 164 - 175) states that Resident 161 had diagnoses of dementia, Alzheimer's disease with paranoia, and obsessive/compulsive disorder. Ms. Kardasz's review of nursing notes indicated that on September 22, 1999, at 6:45 P.M., the resident became weak and was lowered to the floor. At this time, the resident was hypertensive, with a blood pressure of 208/90. On September 24, at 12:20 P.M., the resident fell in her room. The resident stated that her slippers were too slick. The nurse documented that the slippers had treads that were worn thin. The nurse documented that the resident was afraid to ambulate by herself. On September 25, at 1:15 A.M., the resident called out for help and was found on the floor between her bed and the wall. The record was silent as to implementation of comprehensive interventions to prevent further falls and to address the resident's fear of falling.

Petitioner asserts that Resident 161 had a diagnosis of Parkinson's disease which produces difficulty with ambulation. Petitioner also asserts that Ms. Kardasz agreed that if Petitioner had shoes which gripped instead of being smooth it might cause a resident with Parkinson's to pitch forward and fall. Petitioner also noted that Ms. Kardasz vacillated as to whether a shoe could be too smooth and contribute to a fall, although Petitioner noted that her opinion was that a resident is a better judge than staff of when a shoe is too slick. Petitioner argued that interventions were documented in this resident's medical record (citing P. Ex. 18), including physical therapy and a walker, which Ms. Kardasz acknowledged to be interventions related to falls. Petitioner asserts that Resident 161's combination of Parkinson's disease and Alzheimer's disease produced irritability. Petitioner argues that a facility is required to promote the maximum functional independence of its residents and allow them to do as much for themselves as possible, and it's a matter of judgment as to when to interfere with that ability. Finally, Petitioner argues that the fact that the resident was found on the floor does not mean that the resident fell. Moreover, interventions were put in place, a physician's visit and a referral to a specialist. Petitioner insists that there was no deficient practice in this case. P. Br. at 8 - 9.

Petitioner again misses the point. This resident essentially fell three times in four days. Petitioner has not rebutted Petitioner's prima facie case that it did not implement an immediate needs care plan to address these falls, nor has Petitioner shown that it was addressing these falls in some other manner.

6. The amount of the CMP imposed against Petitioner by CMS, $33,600, is reasonable.

I have found a basis for imposing the CMP for the period of time CMS has assessed. I now must consider whether the amount imposed is reasonable, applying the factors listed in 42 C.F.R. � 488.438(f). My "inquiry should be whether the evidence presented on the record concerning the relevant regulatory factors supports a finding that the amount of the CMP is at a level reasonably related to an effort to produce corrective action by a provider with the kind of deficiencies found and in light of the other factors involved." CarePlex of Silver Spring, DAB No. 1683, at 8 (1999).

CMS has imposed a penalty of $600 a day, which is at the lower end of the range ($50 to $3,000) for CMPs imposed for deficiencies that do not constitute immediate jeopardy, but either cause actual harm, or cause no actual harm but have the potential for causing more than minimal harm. In this case there is a repeat deficiency and the deficiencies cited are serious, constituting actual harm to facility residents. Petitioner's brief did not cite to any evidence regarding its financial condition, other than a brief reference to information provided to CMS witness Tim Weidler reflecting a net operating loss and negative shareholder's equity. P. Br. at 9. Under these circumstances, and in the absence of any other cited evidence, I find CMS's determination to be reasonable, and I sustain the CMP assessed by CMS.

VI. Conclusion

For all the reasons discussed above, I uphold CMS's determination that, from August 6, 1999 through September 30, 1999, Petitioner was out of substantial compliance with program participation requirements. I also affirm CMS's determination to impose a CMP of $33,600 against Petitioner for the deficiencies identified.

Richard J. Smith

Administrative Law Judge

1. When this case was initially docketed, CMS was referred to as the Health Care Financing Administration or HCFA. HCFA has since been renamed the Centers for Medicare & Medicaid Services or CMS. When I refer to anything in the record previously submitted as the Health Care Financing Administration or HCFA, I refer to it as the Centers for Medicare & Medicaid Services or CMS.

2. An annual life safety code survey was also completed on August 5, 1999. One deficiency was found, but I do not address it in this decision. See CMS Ex. 5.

3. CMS states that it was following the July 26 fall, not the July 24 fall, that Resident 2's physician ordered the x-ray. However, whether the x-ray was ordered following the resident's fall on July 24 or July 26 is immaterial - the gravamen of CMS's citation of a deficiency is that the results of the x-ray were not reported to Resident 2's physician.

4. A pressure sore means ischemic ulceration and/or necrosis of tissues overlying a bony prominence subjected to pressure, friction, or shear. Pressure sores are assessed in four stages. Stage I is a persistent area of redness (without a break in the skin). It's an area of pressure that once the pressure is relieved the area of redness does not go away. Stage II is when there is actual superficial tissue loss and the area is open, and which presents clinically as an abrasion, blister, or shallow crater. Stage III is a deeper wound, and a partial but not full loss of thickness that presents as a deep crater with or without undermining adjacent tissue. Stage IV is where there is a full thickness tissue loss as well as any necrosis, exposing muscle and/or bone. The risk factors for pressure sores include debilitation, nutrition, and vascular issues and, specifically, such diagnoses as peripheral vascular disease, diabetes, and cerebral vascular accidents which limit an individual's ability to move extremities. The elderly are at greater risk because of their nutrition, hydration, and limited abilities. Tr. 33 - 34; State Operations Manual, page 93.

5. A soft waist restraint such as the one Resident 7 wore goes around a resident's waist and ties to the back of a wheelchair or to part of a bedframe. Tr. 125, 274 - 275.

6. I note that Petitioner cites to P. Ex. 2, at 325 - 330, in support of Ms. Vincent's testimony as to the facility's interventions, which testimony included the facility's having changed Resident 7's room, moved her closer to the nurse's station, given her the side-rails with the soft waist device, a low bed with a mat on the floor, and the replacement of the soft waist device with a lap tray. However, the pages cited from this exhibit (P. Ex. 2, at 325 - 330), consist of copies of physician order sheets for Resident 7. P. Ex. 2, at 327 - 329 consist of orders for dates from August 13 - 29, 1999, after the dates of the survey and immaterial to the deficiency cited here. P. Ex. 2, at 328 and 329, consist of physician orders from August 3 - 6, 1999, generated during the survey resulting in the deficiency, and appear to be responding to surveyor concerns, not to be separately generated facility exhibits, to wit: from the August 3, 1999 order ("D/C Top [half] SR [up arrow] X2 [change] to bilateral siderails [up arrow] X2"); from the August 5, 1999 order ("OT eval if fx per poc for positioning is restraint reduction"); from another August 5, 1999 order ("D/C ot order for eval @ fx. P.T. screen for restraint needs"); and from an August 6, 1999 order ("D/C siderails, D/C soft waist restraint per PT recommendations"). Only P. Ex. 2, at 330, consists of orders generated prior to the survey, and the only order pertinent to the deficiency cited here is an order dated July 12, 1999, which merely states "[r]emove soft waist restraint at all meals at resident's convenience when supervised."