Date: 1999 April 30

I decide that Petitioner, Libbie Convalescent Center, was not in substantial compliance with Medicare participation requirements at the time of the August 1998 survey. Consequently, the Health Care Financing Administration (HCFA) had the authority to terminate Petitioner's Medicare provider agreement.

Petitioner is a skilled nursing facility located in Richmond, Virginia. HCFA initially found that Petitioner was not in substantial compliance with Medicare participation requirements based on a February 24-27 and March 2-3, 1998 survey by the Commonwealth of Virginia Department of Health, Center for Quality Health Care Services and Consumer Protection (State survey agency). Subsequently, HCFA found that Petitioner remained out of compliance with Medicare participation requirements, based on two revisit surveys, on May 13-15 and May 18-19, 1998; and on August 3-7, 1998.

Petitioner timely requested a hearing. The parties agreed that I would decide only the termination issue, based on only the August 1998 survey. HCFA terminated Petitioner' s Medicare provider agreement effective September 28, 1998.⁽¹⁾ The hearing before me was held December 3-6, 1998, in Washington, D.C. During the hearing, Petitioner offered into evidence 161 exhibits (P. Exs. 1-161) and HCFA offered into evidence 55 exhibits (HCFA Exs. 1-40, 42-44, 46-57), each of which I admitted into evidence. Following the hearing, the parties submitted briefs. Petitioner' s brief is referred to as P. Br. HCFA' s brief is referred to as HCFA Br.

Based on the evidence of record and applicable law, in light of the parties' arguments, I determine that Petitioner was not in substantial compliance with Medicare participation requirements at the time of the August 1998 survey.

Medicare, a federally subsidized health insurance program for the elderly and disabled, was established under Title XVIII of the Social Security Act (Act). Medicare provides reimbursement for certain services rendered by providers, such as skilled nursing care facilities (SNFs) like Petitioner, who participate in the Medicare program under "provider agreements" with the United States Department of Health and Human Services (DHHS). In order to enter into such an agreement, a SNF must meet certain requirements imposed by applicable statute and regulations. Act, section 1819 [42 U.S.C. § 1395i-3]; 42 C.F.R. Parts 483, 488, and 489. The requirements for participation in Medicare by SNFs are set forth in 42 C.F.R. Part 483. A SNF is subject to the survey, certification, and remedies provisions of 42 C.F.R. Part 488 and to the provisions governing provider agreements in 42 C.F.R. Part 489.

The survey process is the means by which DHHS (through HCFA) assesses providers' compliance with participation requirements. State survey agencies, under agreements with HCFA, perform the surveys of SNFs and make recommendations to HCFA as to whether such facilities meet federal requirements for Medicare participation. Act, section 1864(a); 42 C.F.R. §§ 488.10, 488.11, 488.20. The results of these surveys are used by HCFA as the basis for its decisions regarding a SNF's initial or continued participation in Medicare. HCFA, not a State survey agency, makes the determination as to whether a facility is eligible to participate or remain in Medicare. Id.

The regulations define "substantial compliance" as "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. § 488.301. HCFA terminates a SNF's provider agreement if it is not in substantial compliance within six months from the last day of a survey from which it was found to be out of substantial compliance. 42 C.F.R. § 488.412. HCFA is authorized to terminate the participation of a SNF which it determines is not in substantial compliance with participation requirements even if it has not been out of substantial compliance for six months. 42 C.F.R. §§ 488.412, 488.456(b)(1)(i), 489.53(a)(3). The parties in this case stipulated, however, that if Petitioner was in substantial compliance with Medicare participation requirements at the time of the August 1998 survey, HCFA would not terminate Petitioner's Medicare participation.

The burden of proof is governed by the decision of an appellate panel of the Departmental Appeals Board in the case of Hillman Rehabilitation Center, DAB No. 1611 (1997). Under Hillman, HCFA bears the burden of coming forward with evidence sufficient to establish a prima facie case that Petitioner was not in substantial compliance with a participation requirement at issue. Once HCFA has established a prima facie case, Petitioner has the ultimate burden of persuasion: to prevail, Petitioner must prove by a preponderance of the evidence that it was in substantial compliance with the requirement.

The issue is whether Petitioner was in substantial compliance with Medicare participation requirements at the time of the August 1998 survey.

1. Quality of care: Pressure sores. Petitioner was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(c)(2), regarding pressure sores, at the time of the August 1998 survey.

2. Quality of care: Range of motion. Petitioner was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(e), regarding range of motion, at the time of the August 1998 survey.

3. Quality of care: General. Petitioner was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25, regarding quality of care generally, at the time of the August 1998 survey.

4. Quality of care: Activities of daily living. Petitioner was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(a)(3), regarding grooming and hygiene, at the time of the August 1998 survey.

5. Quality of care: Accidents. Petitioner was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(h)(2), regarding accidents, at the time of the August 1998 survey.

6. Quality of care: Unnecessary drugs. Petitioner was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(l)(1), regarding unnecessary drugs, at the time of the August 1998 survey.

7. Quality of care: Nutrition. Petitioner was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(i)(1), regarding nutrition, at the time of the August 1998 survey.

8. Quality of care: Incontinence. Petitioner was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.25(d)(2), regarding incontinence, at the time of the August 1998 survey.

9. Resident assessments: Comprehensive care plans. Petitioner was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.20(k), regarding comprehensive care plans, at the time of the August 1998 survey.

10. Physician services: Physician visits. Petitioner was not in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.40(b)(3), regarding signing and dating all orders, at the time of the August 1998 survey.

11. HCFA had the authority to terminate Petitioner's Medicare agreement.

After careful consideration, I find four quality of care deficiencies and one physician services deficiency. The evidence does not show the existence of other deficiencies.

Several principles guide my analysis here:

1. By the terms of the parties' stipulation dated October 30, 1998,⁽²⁾ I need review only the findings from the August 1998 survey. Petitioner agreed not to challenge the prior surveys in this case. Under these circumstances, I will not look back to events that occurred prior to May 19, 1998, the exit date of the previous survey, in my review of the deficiencies alleged from the August survey.

2. Whether adequate notice was provided to Petitioner, regarding the identity of some of the residents involved in the August 1998 survey, is an issue in this case. As discussed below in Part IA, I find that HCFA failed to provide Petitioner with adequate notice regarding the identities of residents 19-26 and therefore I will not consider any evidence that concerns residents 19-26. HCFA did not meet its burden of providing adequate notice as to resident identities after a mistake in numbering the residents was discovered and corrected by the survey team, following the termination of the survey. The survey team renumbered the residents beginning with resident 19, and used the renumbering in the Statement of Deficiencies, HCFA form 2567. HCFA failed to notify Petitioner in writing of the renumbering.

3. Certain of Petitioner's documents that were copied during the survey were subsequently altered. The differences between documents submitted by Petitioner and otherwise identical documents submitted by HCFA were noted by HCFA. The differences between the documents that the surveyors were given during the survey and the documents that Petitioner later provided as exhibits were not accounted for by an acceptable procedure by Petitioner's staff, such as "late entries" to the documents. Deliberately misleading alteration was not proved by the evidence. I find that I am unable to draw a useful conclusion from the differences in the documents.

4. Evidence that was not provided to the surveyors at the time of the survey was offered to me. The Dilantin level of June 14, 1998, discussed below in Part IC, was not provided to the surveyors during the survey, nor during the Informal Dispute Resolution (IDR), nor during the prehearing exchange. It was presented for the first time during the hearing. P. Ex. 161; Tr. at 1293. I am reluctant to exclude a document which is relevant to the period covered during the survey and the issues raised by the deficiency citations. I determined to admit that evidence, finding that the prejudice to HCFA was outweighed by Petitioner's need. HCFA's counsel were given an opportunity to review the newly submitted evidence and discuss it with its witnesses. I admitted P. Ex. 161 into evidence. Tr. at 1293.

5. Petitioner requires a reasonable amount of time in which to see to the residents' needs. This is particularly applicable to grooming deficiencies as discussed in Part ID. This is applicable also to deficiencies involving care plans discussed in Part II. When there is a significant change in a resident's condition, a reasonable amount of time is required for the facility to respond, to assess the resident, and to augment the resident's care plan. A reasonable amount of time is required even to determine that a resident has indeed experienced a significant change in condition. An example of this is discussed in Part IE where a resident needed to be evaluated for being at risk of falls.

I. Quality of care.

Following the August 1998 survey, HCFA cited Petitioner with deficiencies in eight quality of care categories, discussed in sections A through H, below.

A. Pressure sores. A quality of care regulation subsection, concerning pressure sores, cited following the August survey, 42 C.F.R. § 483.25(c)(2), 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.
. . . .
(c) Pressure Sores. Based on the comprehensive assessment of a resident, the facility must ensure that--
. . . .
(2) A resident having pressure sores receives necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.

42 C.F.R. § 483.25(c)(2); HCFA Ex. 1 at 35.

To support the allegation that Petitioner failed to comply with this requirement, the situations of two residents, Resident S.A. (#2) and Resident N.W. (#25) are detailed at tag F 314 on the HCFA 2567. HCFA Ex. 1 at 35-44.

The preponderance of the evidence shows that Petitioner failed to turn and reposition resident 2 frequently enough to promote healing, thereby manifesting Petitioner's noncompliance with participation requirements in respect to tag F 314.

S.A. (resident 2) was at risk for developing pressure sores. A pressure sore had existed on her right buttock for six months. This pressure sore had waxed and waned in size from March through August 1998. P. Br. at 35; HCFA Ex. 4 at 39-52. In essence, the alleged deficiency is that Petitioner failed to care properly for this Stage III pressure sore and that the resident thereby suffered actual harm because a trip to the hospital for the resident's wound to be surgically debrided had been scheduled. Surgery was performed on this resident in mid-August. HCFA alleges that this resident had the ability to heal because she had a history of previous bed sores that had healed in the past and a pressure sore on the left buttock had healed during the same time period. Tr. at 1257.

HCFA alleges that Petitioner failed to turn and reposition resident 2 frequently enough to promote healing. HCFA points to a repositioning flow chart from June which fails to show that the resident was repositioned at all during the 7:00 a.m. - 3:00 p.m. shift for a total of nine shifts; during the 3:00 p.m. - 11:00 p.m. shift for a total of five shifts; and during the 11:00 p.m. - 7:00 a.m. shift for a total of eight shifts. Tr. at 1259-1260; HCFA Ex. 4 at 64. Petitioner's medical director, Dr. Vranian, testified that there is a standard of care to turn patients with decubiti (pressure sores) every two hours. Tr. at 389. Ms. Thurnher, the clinical services coordinator of Petitioner's parent company, testified that generally patients are repositioned every two hours and if needed, more frequently. Tr. at 1258. Ms. Thurnher also testified that the repositioning flow chart is filled in only by the certified nurses aides (CNAs), and that other staff, such as LPNs and RNs, might turn residents as well.

Even if other staff would occasionally turn residents, turning is generally the duty of the CNAs. Petitioner failed to present any evidence that resident was turned during these 22 eight-hour shifts other than this vague statement by Ms. Thurnher. Since the June repositioning flow chart fails to show that resident 2 was turned, for a total of 22 eight- hour shifts, in violation of the standard of care, I find that HCFA established a prima facie case of noncompliance with participation requirements that Petitioner did not rebut by a preponderance of the evidence.

HCFA bases this deficiency on other failures by Petitioner, as well. I do not find that Petitioner failed to care properly for resident 2's pressure sores in any aspect, other than failure to turn and reposition.

Resident N.W. (#25)

I find that HCFA failed to provide Petitioner with adequate notice of any deficiencies that involve resident 25. When HCFA determines to impose a remedy, HCFA must give the provider advance notice of its determination. 42 C.F.R. § 488.402(f)(1). The notice must inform the provider of the nature of the provider's noncompliance with participation requirements, among other things, as a prerequisite to imposing a remedy against the provider. 42 C.F.R. § 488.402(f)(1)(i). HCFA may not rely on a general or vague statement that the provider is not complying with participation requirements, nor may HCFA give the provider an inomplete or erroneous statement of the provider's deficiencies. The regulation requires nothing less than a complete and accurate disclosure.

Under the reasoning stated in Hillman, HCFA has an initial obligation to set forth the basis for its determinations with sufficient specificity to allow a provider to respond (the obligation to make a prima facie case). It is obvious that HCFA's obligation to set forth, with particularity, the basis for its determinations, must be accurate. In this case, HCFA failed to provide Petitioner adequate notice of any deficiency that relates to Residents 19-26.

During the hearing there was testimony from Dr. Crosier, a surveyor, that an error was made by the survey team. On the numbered list of residents presented to Petitioner, Resident 12 is listed twice as both resident 12 and resident 19. Tr. at 303. When the statement of deficiencies was written up by the survey team, resident 19 was omitted and all the subsequent residents were moved up one number, so that resident 20 became 19 and resident 21 became 20 and so forth. The survey team renumbered the residents beginning with resident 19 and based the 2567, Statement of Deficiencies, on the renumbering. HCFA did not, in writing, notify Petitioner of this error, and Petitioner was not provided a corrected resident list.

In fact, according to the testimony of Ms. Stone, a surveyor, it was Petitioner that raised the issue of the confusion in resident identities at the IDR that was conducted on September 30, 1998, one month after Petitioner appealed HCFA's determination of substantial noncompliance. According to Ms. Stone, Petitioner was informed at the IDR, orally, of the error in the numbering of the residents. Tr. at 474-476. However, when an IDR is conducted, the provider is not allowed to be represented by counsel. This is so even when an appeal is in process and counsel that is representing the provider has submitted a notice of appearance. Even after the IDR was concluded, HCFA never sent Petitioner or its counsel a written notification of the error in resident numbering. The exchange between counsel at the hearing made it evident that, at least in respect to two individuals identified as N.R. and N.W. and variously identified as residents 24, 25, and 26, that there was real confusion on the part of Petitioner as to the resident identities referred to in the statement of deficiencies. Tr. at 920-928.

The burden of providing adequate notice must be placed on HCFA. A provider should not be put in the position of second guessing the statement of deficiencies as to resident identities. When HCFA realized its mistake, it was incumbent on it to notify Petitioner, in writing, of this essential information. Informing Petitioner, orally, in a forum where it cannot be represented by counsel, is not sufficient notice. When such information is conveyed orally there is a serious risk of misunderstanding, error, or miscommunication, as appears to have happened as regards residents N.R. and N.W. HCFA argues that Petitioner received notice at the time of the prehearing exchange, which occurred on November 15, 1998, in the contents of declarations submitted by the surveyors. I do not find merit in this argument. Such essential information should not be buried in the midst of a huge exchange. Petitioner should not be put in the position of having to hunt for this information when HCFA has the burden of providing adequate notice. For these reasons, I find that HCFA failed to provide Petitioner with adequate notice as regards residents 19-26 and I will not consider any evidence that concerns these residents.

B. Range of motion. A quality of care regulation subsection, concerning range of motion, cited following the August survey, 42 C.F.R. § 483.25(e)(2), 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.

. . . .
(e) Range of Motion. Based on the comprehensive assessment of a resident, the facility must ensure that--
. . . .
(2) A resident with a limited range of motion receives appropriate treatment and services to increase range of motion and/or to prevent further decrease in range of motion.

42 C.F.R. § 483.25(e)(2); HCFA Ex. 1 at 47.

To support the allegation that Petitioner failed to comply with this requirement, the situation of resident M.S. (#8) is detailed at tag F 318 on the HCFA 2567. HCFA Ex. 1 at 47-49.

The preponderance of the evidence shows that Petitioner failed to continuously provide resident 8 with a hand roll⁽³⁾ as ordered by her physician, thereby manifesting Petitioner's noncompliance with participation requirements in respect to tag F 318.

Resident 8 had lost all voluntary movement in her right hand, wrist, and fingers. Tr. at 524-529. As a result, the resident's physician ordered that she wear a hand roll, abductor, splint, and a palm guard at all times except for bathing and range of motion exercises. HCFA Ex. 25 at 11. Surveyor, Shirly Stone, R.N., observed resident 8 during the survey. Resident 8's hand was contracted, clenched in a tight fist and in an inappropriate anatomical position. Resident 8 did not have a hand roll in her right hand. The surveyor was told the the hand roll was being laundered. Tr. at 345-350, 519-520, 524-529; HCFA Ex. 54 at 5. The facility does not deny that resident 8 was observed with her hand contracted and closed and without a hand roll.

Although resident 8 had lost active range of motion in her right hand, wrist, and fingers, she still retained passive range of motion, in that someone else could uncurl her clenched fist. However, when the resident's hand was opened, in the presence of the surveyor, the resident experienced pain which indicated to the surveyor that the hand roll had not been in place for some time period that exceeded the time it would take to launder the hand roll. Tr. at 524-525.

Petitioner argues that the hand roll was being laundered and that this device was returned from the laundry "within a few minutes." P. Br. at 41. I am not impressed with this argument, even though the evidence does show that the hand roll was returned to resident 8 shortly after the surveyor made her observation. Petitioner failed to present any evidence to show how long resident 8 had been without the hand roll. Petitioner did not provide any evidence as to the time needed to process the laundry, the length of the laundry cycle, or its efforts to ensure that the hand roll would be returned to resident 8 promptly when the laundry was done.

Not providing resident 8 with a hand roll at all times as ordered by the physician, placed resident 8 at a risk for more than minimal harm. The hand roll, abductors, splints, and palm guard were prescribed to maintain resident 8's passive range of motion, the flexibility in her joints to allow a caregiver to open her hand when neccessary, for example to clean the hand. Without these devices, the contracted hand would tighten up and cause resident 8 to have pain when the hand was opened by a caregiver, passive range of motion would not be maintained, and resident 8 would be susceptible to pressure sores and infections. Tr. at 353-355, 524-529, 584-585, 807-808; HCFA Ex. 54.

It is uncontroverted that resident 8 did not have a hand roll on the day of the survey. The evidence is confusing as to whether there were other times that resident 8 was without her hand roll.⁽⁴⁾ The facility did not provide any evidence relating to the length of time that resident 8 was without the hand roll. Nor did the facility explain why another hand roll was not provided to resident 8 during the time her usual hand roll was being laundered. Both the surveyor, Ms. Stone, and one of Petitioner's witnesses, Ms. Sodergren, agreed that another hand roll or a similiar substitute could have been provided to resident 8 during the time the hand roll was laundered. Tr. at 347-348, 521-522, 1031-1032. In light of the physician's orders that a hand roll be used continuously, the facility's failure to ensure that the hand roll was used twice, at the least, during the month of July and the facility's failure to provide a substitute for the hand roll during laundering manifests the facility's noncompliance with Medicare participation requirements.

C. General. A quality of care regulation, cited generally under 42 C.F.R. § 483.25, during following the August survey, 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.

42 C.F.R. § 483.25; HCFA Ex. 1 at 10.

To support the allegation that Petitioner failed to comply with this requirement, the situation of three residents, Resident V.N. (#7), Resident A.L. (#1), and Resident M.W. (#14)⁽⁵⁾ are detailed at tag F 309 on the HCFA 2567. HCFA Ex. 1 at 10-20.

The preponderance of the evidence shows that Petitioner failed to the provide care and services necessary to alleviate resident 14's constipation and related discomfort, thereby manifesting Petitioner's noncompliance with participation requirements in respect to tag F 309.

HCFA alleges that the Petitioner failed to provide care and services necessary to alleviate the alleged constipation and related discomfort of which resident 14 complained. HCFA Ex. 1 at 17-20; HCFA Ex. 51 at 19-22; Tr. at 180-195.

Resident 14 reported to the surveyor, Ms. Casey, that she was uncomfortable due to constipation. HCFA Ex. 51 at 21-22; Tr. at 181-182. On August 3, 1998, the first day of the survey, resident 14 complained to Ms. Casey that she had not had a bowel movement in three days and was uncomfortable even though she had been given Milk of Magnesia the night before. This resident was prone to constipation since it was a side effect of the medication she was receiving. HCFA Ex. 6 at 33; Tr. at 190. A doctor's order dated July 9, 1998 stated that the resident should receive Milk of Magnesia with cascara, as needed every four hours for constipation. HCFA Ex. 6 at 39; P. Ex. 77.

When asked by Ms. Casey, on August 4 and 5, 1998, the resident complained that she was still experiencing discomfort. Petitioner's nurse performed a rectal examination on August 4, 1998 and confirmed that stool was present in the rectum. HCFA Ex. 51 at 21; Tr. at 190-191. HCFA argues that when one dose of the laxative proved ineffective, Petitioner's staff should have given the resident another dose as provided for by the physician's order of July 9, 1998. In addition, HCFA argues that other nursing interventions should have been taken, such as walking the resident around or giving her a warm drink or the like. Tr. at 193, 195; HCFA Ex. 51 at 21. Petitioner did not give resident 14 another dose of Milk of Magnesia until August 5, 1998. P. Ex. 77. On August 6, 1998, the resident experienced relief. The potential for harm was more than minimal because resident 14 experienced avoidable discomfort for several days.

Petitioner argues that the Daily Care sheet for August shows that resident 14 had a bowel movement on four consecutive days, August 3, 4, 5, and 6, 1998. Tr. at 1183; P. Ex. 71. Given this documentation, Petitioner argues that HCFA cannot base a deficiency solely on the resident's complaint. P. Br. at 25.

However, Petitioner's nurse confirmed by a rectal examination that stool was present in the rectum on August 4, 1998. The annual comprehensive assessment dated July 13, 1998, noted that the resident is cognitive 1 (modified independence). This assessment indicates that she has no difficulty in making herself understood or in understanding others. HCFA Ex. 1 at 18. In addition, Ms. Casey testified that it is possible to have bowel movements that are not sufficient in volume to allow a resident to experience relief. Tr. at 183, 190; HCFA Ex. 51 at 20-21. Ms. Casey also testified that in the elderly population, constipation is a very uncomfortable thing. Tr. at 195. Furthermore, the August Daily Care Sheet indicates that the first time a bowel movement was recorded in the month of August was not until the 3:00 p.m. - 11:00 p.m. shift on August 3, 1998. P. Ex. 71. According to Petitioner's records, Milk of Magnesia was not given until August 5, 1998 even though the physician's order allowed this laxative to be given every four hours as needed. P. Ex. 77. There was no evidence that other interventions were tried by Petitioner's staff, other than an X-ray that was performed to rule out the possibility of an obstruction as the cause of the resident's discomfort. P. Ex. 76. For the reasons stated above, I find that the events relating to resident 14 supports the finding of noncompliance with participation requirements as to tag F 309.

The essence of HCFA's allegation is that Petitioner failed to both obtain a Dilantin level for resident 7 on May 14, 1998 as ordered by her physician and failed to monitor this resident's Dilantin levels subsequent to May 14, 1998, as ordered by the physician.

Resident 7 was hospitalized for Dilantin toxicity in May 1998. She was readmitted to Petitioner on May 13, 1998. Tr. at 361-362; HCFA Ex. 24 at 274. Dilantin is an anti-seizure medication. Tr. at 361. However, if the dose of Dilantin is too high, side effects such as confusion, slurred speech, ataxia, nausea, vomiting, and cardiac fibrillation can occur. On the other hand, if the dosage is too low, the patient can have seizures and can injure herself during the seizure. Tr. at 811-817; HCFA's Br. at 25. It is therefore important to monitor a patient on Dilantin so that the proper dosage can be determined within the therapeutic range. This would especially be essential in a patient who had just been hospitalized for Dilantin toxicity. If Petitioner failed to obtain and monitor resident 7's dilantin levels, as alleged by HCFA, then Petitioner was putting this resident at risk for more than minimal harm.

On May 14, 1998, a physician's order stated that the dilantin level should be checked on that day and then every month. HCFA Ex. 24 at 6; P. Ex. 61. The evidence shows that the laboratory was called to do the test on May 14, 1998. HCFA Ex. 24 at 15; Tr. at 508-509. The surveyor, Ms. Stone could not find the laboratory result for the May 14, 1998 Dilantin level. Petitioner concedes that it cannot find the result. P. Br. at 22. There was no evidence that Petitioner followed up with the laboratory to see if this test was even done, and no evidence that Petitioner notified the physician of the result, if indeed, Petitioner obtained such a result. For a resident that had just returned from the hospital the day before and who was hospitalized for Dilantin toxicity, this lapse on Petitioner's part could result in a potential of more than minimal harm. Petitioner argues that there would be a reasonable inference that the May 14, 1998 Dilantin was done since the June 14, 1998 level,⁽⁶⁾ which was ordered at the same time, was done timely. I do not agree. I find that such an inference is far from reasonable in the absence of any other evidence to support Petitioner's inference. Petitioner also argues that the events of May 14, 1998 should not be considered by this forum because the Petitioner had undergone an earlier survey which ended May 19, 1998 and no deficiency on this matter was cited in the earlier survey. Tr. at 1132; HCFA Ex. 36. I find merit in Petitioner's argument primarily because of the parties' stipulation in which they agreed to limit this hearing only to the August survey. Under the circumstances of this case, I will not look back to events that occurred prior to the end of the previous survey.

On June 19, 1998, there was a physician's order that Dilantin levels be checked every month starting in one month, July 19, 1998. HCFA Ex. 24 at 12. This order was placed on a Standing Order Information Sheet. HCFA Ex. 24 at 33. The Standing Order Information sheet specifies that a Dilantin level is to be done on July 19, 1998, a date certain. The patient was in residence at Petitioner on July 19, 1998. The surveyors did not find a Dilantin level in resident 7's chart for that date. Tr. at 1309. Petitioner does not deny that there was no Dilantin level done on July 19, 1998.

Petitioner claims that resident 7 was never at the Petitioner for 30 consecutive days and therefore could not comply with this order. Petitioner states that this resident was in and out of Petitioner's facility very often. Resident 7 was hospitalized on June 16, 1998 and then readmitted to Petitioner on June 19, 1998. Resident 7 was again hospitalized on July 8, 1998 and readmitted to Petitioner on July 17, 1998. HCFA Ex. 54 at 11-14; Tr. at 493-503. Petitioner concedes that it did not arrange for a Dilantin level to be taken between June 14, 1998 and the date of the survey. Petitioner also concedes that the record did not indicate whether a Dilantin level was performed in the hospital. P. Br. at 23. There was no indication in the nurses' notes or record that the nurses confirmed whether the physician wanted his June 19, 1998 order to be followed. However, prior to the date on which the Dilantin level was to be done, July 19, 1998, resident 7 was discharged to the hospital and then readmitted to Petitioner on July 17, 1998. The attending physician, upon resident 7's readmittance, again placed an order as to Dilantin levels. The July 17, 1998 order says that Dilantin levels should be done every month starting in one month, August 17, 1998, after the August survey. P. Ex. 61 at 8. Given the testimony of Dr. Vranian, who testified that a new admission order supersedes an old order that addresses the same issue, I find that Petitioner was in substantial compliance with participation requirements as to tag F 309 as it relates to resident 7. Tr. at 405.

HCFA alleges that, as relates to resident 1, Petitioner's staff failed to conduct an accurate evaluation of the resident's condition after a fall that occurred on June 12, 1998 and consequently ambulated resident 1 back to her bed on a fractured hip which presents a potential for more than minimal harm. HCFA Ex. 1 at 14-17.

It is uncontested that resident 1 was found on the floor, near the foot of her bed, on June 12, 1998 at 3:00 p.m. Two nurses assessed the resident, ambulated resident 1 back to bed, and 40 minutes later resident 1 was assessed again and found to have a protruding hip and to have one leg shorter than the other leg. HCFA Ex. 3 at 50-51; Tr. at 137-138. The resident was transported to the hospital at 4:15 p.m. and diagnosed with a fractured hip. HCFA Ex. 3 at 51, 74.

The evidence indicates that two nurses were present at the time the resident was assessed at 3:00 p.m. The nurse who arrived first performed a range of motion test. The result of the range of motion test was that it was within normal limits and this was noted in the nurses notes by the second nurse. HCFA Ex. 3 at 51; Tr. at 137-138. The evidence shows that there was no indication of injury, at the time the first range of motion occurred, that was noted in the resident's chart. At this time, the resident was alert and talking. HCFA Ex. 3 at 5. Forty minutes later, the resident was assessed again and her hip appeared fractured. Petitioner speculates that resident 1 fractured her hip by getting caught in the side rails.

During the August survey, Ms. Casey interviewed the first nurse who had conducted the range of motion in the first assessment. When Ms. Casey asked if the first nurse had noticed any injury to the resident's leg, the nurse replied that she thought the leg was dislocated at the time of the first assessment. HCFA Ex. 1 at 17; HCFA Ex. 2 at 9; Tr. at 39. HCFA alleges that Petitioner's staff walked the resident back to bed anyway. Tr. at 38-39, 138, 142. HCFA argues that the first nurse's statement must be given great weight because it is an admission against interest. HCFA Br. at 26. I disagree. I find that the first nurse's statement should be given little weight since I find it unreliable. This statement was made under the pressure of a survey, when confronted by a surveyor. This statement was also made more than seven weeks after the incident occurred and with the benefit of hindsight, knowing that the resident was diagnosed with a fractured hip shortly after the fall. There is no indication that the first nurse ever communicated her belief to anyone else on the staff at the time of the incident. In fact, the range of motion during the first assessment was noted in the patient's chart as within normal range and no other indications of injury were noted. More importantly, the first nurse's actions in ambulating the patient back to bed fly directly in the face of her later statement. Had she believed that resident 1's leg was dislocated at the time she performed the initial assessment, she would have indicated that to the other nurse in some way that should have been reflected in the record. HCFA's reliance on the Incident Report is also misplaced because although Petitioner checked off the box on the form indicating a possible fracture, the Incident Report was not limited to the time of 3:00 p.m. but includes the later assessment and transfer of the resident to the hospital. HCFA Ex. 3 at 5

Alternatively, if the nurse's statement is indeed accurate, which I believe is unlikely absent any other corroboration, and she made a mistake in her initial assessment and never indicated her mistake to any other of Petitioner's staff, the mistake was addressed by the reassessment of the resident 40 minutes later. Ms. Casey conceded that a follow- up assessment is essential when dealing with a fall and that one of the purposes of the follow-up assessment was to catch something that had not been caught during the earlier assessment. Tr. at 135.

Dr. Crosier, also a surveyor, testified that if a nurse finds a resident's range of motion normal following a fall, then it is an acceptable standard of practice to ambulate a patient back to bed. Tr. at 333. Given Dr. Crosier's testimony, the lack of weight I give to the nurse's statement seven weeks after the incident and the fact the resident 1 was alert and talking, I find that Petitioner was in substantial compliance with participation requirements, as to tag F 309, as it relates to resident 1.

D. Grooming. A quality of care regulation subsection, concerning grooming, cited following the August survey, 42 C.F.R. § 483.25(a)(3), 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.

(a) Activities of daily living. Based on the comprehensive assessment of a resident, the facility must ensure that--
. . . .
(3) A resident who is unable to carry out activities of daily living receives the necessary services to maintain good nutrition, grooming, and personal and oral hygiene.

42 C.F.R. § 483.25(a)(3); HCFA Ex. 1 at 21.

To support the allegation that Petitioner failed to comply with this requirement, the situations of 14 residents are detailed at tag F 312 on the HCFA 2567. ⁽⁷⁾ HCFA Ex. 1 at 21-35.

The preponderance of the evidence shows that Petitioner failed to adequately groom and provide good hygiene to both residents 7 and 8, thereby manifesting Petitioner's noncompliance with participation requirements in respect to tag F 312.

Several residents were found by the surveyors not to have been bathed or have their hair shampooed as often as they should. It is unnecessary to make any findings as to Residents 5, 14, 17, or 18 in light of the evident situation regarding Resident 7. Resident 7 was described as disheveled looking and that her hair was oily or clumped together. Tr. at 358; HCF Ex. 54 at 15-16. Resident 7 was totally dependent on Petitioner to meet her personal hygiene needs. HCFA Ex. 24 at 20, 78. The evidence shows that resident 7's hair was shampooed only once during the month of June, only once during July, and not at all in the month of May. HCFA Ex. 24 at 41, 104-106; HCFA Ex. 54 at 15-16; Tr. at 358-371. Resident 7 was in the hospital between July 7 and July 17, 1998. Petitioner argues that resident 7's hair always looked greasy. Tr. at 1069. It is no wonder that resident 7's hair looked greasy when Petitioner clearly failed to provide this resident with the necessary services to maintain good grooming. A lack of grooming can negatively impact on a resident's psychosocial well-being and has a potential for more than minimal harm.

HCFA alleges that Resident 8, who had a contracted hand, previously discussed in Part IB, was observed by Ms. Stone to have a foul odor coming from her hand and that when the hand was opened, four pieces of debris, possibly skin-like flakes, fell out. HCFA Ex. 1 at 23-25. Resident 8 could not voluntarily open her hand. However, she still had enough flexibility and movement in her joints for her hand to be opened by another person. Tr. at 346-347, 524-529. It was up to Petitioner's staff to open and clean her hand. Tr. at 353-355; HCF Ex. 54 at 16-17. Evidence was presented that the potential for harm was more than minimal in that the resident was at risk for bacterial growth and infections in the area inside her contracted hand and there was a risk of developing pressure sores. Tr. at 353-355, 584-585; HCFA Ex. 54 at 16-17.

Petitioner argues that the observation of resident 8 took place immediately after breakfast and therefore it is not clear what Ms. Stone thought she saw fall from resident 8's hand. P. Br. at 30. I find this argument to be without merit since the resident clearly could not feed herself with such a severely contracted hand. In addition, Petitioner argues that its Director of Nursing, Ms. Lamb, who was present at the time resident 8's hand was opened, testified that she did not see anything fall out of resident's 8's hand and that the hand was clean. Tr. at . 1065-1066, 1099-1102. I find that the testimony of Ms. Stone to be more credible. Ms. Stone's vivid description of her observations, even to describing the clothes worn by resident 8, were clearly an accurate depiction of resident 8. Tr. at 345. The overall tenor of Ms. Stone's testimony was detailed and precise. I find that Petitioner not in substantial compliance with participation requirements as to both residents 7 and 8 under tag 312.

Residents 15 and 16 were both reported as having dirty fingernails and nose hairs. Both were observed early in the day and shortly after breakfast. Resident 15 was observed as having nose hair covered with thick mucous, while resident 16 was observed as having nose hair from both nostrils. They were both observed while Petitioner was still performing the morning care of residents. Tr. at 1071. It is obvious that a provider needs a reasonable amount of time in which to see to the residents' needs. The surveyor who observed these residents conceded that she had not gone back later in the day to see observe these residents. Tr. at 673. Under these facts, I do not find that these residents suffered from a risk of more than minimal harm.

HCFA alleges that Resident 5 was unshaven. The evidence shows that resident 5 refused a shave the day before he was observed, as was common for this resident. The evidence also indicates that this resident was shaved on the two days following the day he was observed. Tr. at 312; P. Ex. 83 at 2. Under these facts, I do not find that this resident suffered from a risk of more than minimal harm.

HCFA cited Petitioner for failure to provide sufficient baths to both residents 17 and 18. This portion of the grooming deficiency was based solely on a review of the resident's records, in particular looking at the frequentcy of tub baths and showers. HCFA Ex. 1 at 34-35. Neither resident was observed by the surveyor. Tr. at 211. At the hearing, the surveyor confirmed that these residents were given bed baths regularly and absent evidence showing that these residents actually had inadequate personal hygiene, this portion of the grooming deficiency cannot be maintained. Tr. at 209-211.

E. Accidents. A quality of care regulation subsection, concerning accidents, cited following the August survey, 42 C.F.R. § 483.25(h)(2), 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--
. . . .
(2) Each resident receives adequate supervision and assistive devices to prevent accidents.

42 C.F.R. § 483.25(h)(2); HCFA Ex. 1 at 49.

To support the allegation that Petitioner failed to comply with this requirement, the situation of one resident, Resident E.S. (#4) is detailed at tag F 324 on the HCFA 2567. HCFA Ex. 1 at 49.

The preponderance of the evidence shows that Petitioner was in substantial compliance with participation requirements specified in 42 C.F.R. § 483.25(h)(2) regarding accidents at the time of the August 1998 survey.

Resident E.S. (#4) was a non-insulin-dependent diabetic with glucose levels low but stable. She needed to be evaluated for being at risk for falls, based on two incidents that were suspicious for falls, which occurred on July 22 and August 2, 1998. HCFA Ex. 13 at 11-12. If such evaluation were to show that she required greater supervision or any assistance devices to prevent accidents, then certainly suggestions such as placing an alarm on her wheelchair (Tr. at 265-266), and discussing with her physician whether to perform Accuchecks to determine her blood sugar level (Tr. at 321), would be worthy of consideration. Nevertheless, at the time of the August survey, I find that it was premature to conclude that any greater supervision or any assistance devices were warranted. Petitioner must be allowed a reasonable time to assess situations such as that of Resident E.S. (#4). I find the evidence insufficient to show any deficiency under tag F 324.

F. Unnecessary drugs. A quality of care regulation subsection, concerning unnecessary drugs, cited following the August survey, 42 C.F.R. § 483.25(l)(1), 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.

(l) Unnecessary drugs.- -

(1) General. Each resident's drug regiment must be free from unnecessary drugs. An unnecessary drug is any drug when used:

(i) In excessive dose (including duplicative drug therapy); or

(ii) For excessive duration; or

(iii) Without adequate monitoring; or

(iv) Without adequate indications for its use; or

(v) In the presence of adverse consequences which indicate that the dose should be reduced or discontinued; or

(vi) Any combination of the reasons above.

42 C.F.R. § 483.25(l)(1); HCFA Ex. 1 at 54.

To support the allegation that Petitioner failed to comply with this requirement, the situation of resident 5 is detailed at tag F 329 on the HCFA 2567.⁽⁸⁾ HCFA Ex. 1 at 54-59.

The preponderance of the evidence shows that Petitioner was in substantial compliance with participation requirements specified in 42 C.F.R. § 483.25(l)(1) regarding unecessary drugs, at the time of the August 1998 survey.

The essence of this alleged deficiency is that resident 5 was given Ativan, an antianxiety drug, on August 1, 2, and 3, 1998 without adequate indications for its use and without first attempting to determine the cause of the anxiety and implementing alternative measures to address the anxiety. HCFA Ex. 53 at 8-9; HCFA Ex. 1 at 55. At the hearing, it was evident that the real deficiency in this case was that Petitioner did not describe what was happening with this resident, in sufficient detail, on the nights of August 1, 2, and 3, 1998, that caused the staff to administer Ativan on those occasions.

Resident 5 is a 54-year-old male with diagnoses with include CVA (stroke), hypertension, blindness, major depression with psychosis, hemiplegia, and seizure disorder. HCFA Ex. 1 at 28. The record indicates that resident 5 had a history of behavioral problems that were well known to the staff. At times, this resident got physically abusive with the staff. Tr. at 624. The resident was attended frequently by psychiatric professionals. Tr. at 625. The resident was on and off various drugs during the time before and during the survey. The resident is described as having "themes of violence" and diagnosed with major depression with paranoid ideation by a psychiatrist in April 1998. P. Ex. 141 at 1. A different psychiatric professional, Dr. Israel, diagnosed resident 5 with depression with agitation on June 8, 1998. P. Ex. 141 at 7. Resident 5 is described as acting impulsively and unreasonably on July 9, 1998 by Dr. Israel. P. Ex. 141 at 11. Resident 5 is further described as aggressive, agitated, unable to control his behavior, impulsive, on July 15, 1998. P. Ex.141 at 12. Resident 5 was prescribed Ativan "as needed" on July 16, 1998 for agitation. P. Ex. 22 at 8; P. Ex. 141 at 13. The record continues to indicate further psychiatric progress notes until and past the survey date. P. Ex. 141 at 14-19.

Resident 5 was involved with behavioral management techniques since May of 1998. Tr. at 707. Although the record reflects that these techniques were somewhat successful, Ativan was still ordered on an "as needed" basis and was to be given when behavioral management techniques were not working. Tr. at 711.

Resident 5 also had a history of begging on the street before he came to Petitioner. At times, he would try to leave Petitioner's facility to beg on the street. Since he was blind, and Petitioner's facility was located adjacent to a busy intersection and a large shopping center, his trying to leave the facility was inappropriate and dangerous behavior. Dr. Israel testified that this type of behavior would trigger the administration of Ativan by the staff, since the resident was putting himself in great jeopardy. Tr. at 726-728. Ms. Lamb, Director of Nursing at Petitioner, testified that on the three nights in question, resident 5 was attempting to leave Petitioner's facility in his wheelchair in order to go beg for money on the street, thereby placing himself in danger. She testified that the only way to keep resident 5 in the building was to administer Ativan. Tr. at 1063-1065. She also testified that the staff attempted to calm resident 5 down prior to giving him the Ativan, but could not. Tr. at 1088.

HCFA does not dispute that Petitioner did document why Ativan was administered on those dates. Petitioner's records show that Ativan was administered for "agitation" and "delusions" on the dates in question. HCFA Ex. 20 at 6; P. Ex. 145 at 6. However, HCFA argues that there was no description of what behaviors existed that triggered the administration of Ativan and no documentation of what behavioral interventions were attempted before the drug was administered. HCFA Br. at 30-31.

In light of the evidence presented, I find that although the word "agitation" is very concise, it is nevertheless descriptive of the resident's state of mind on August 1, 2, and 3, 1998. A more detailed description would have been illuminating but given the staff's familiarity with the resident and the testimony of both Dr. Israel and Ms. Lamb, I am convinced that Petitioner did not administer Ativan without adequate indications for it's use. In addition, when attempts to calm this resident failed and given the facts that the resident had a history of being physically abusive to the staff and was about to place himself in imminent danger, I find that Petitioner acted reasonably in not attempting to institute other behavioral management techniques and in administering Ativan on an as needed basis.

G. Nutrition. A quality of care regulation subsection, concerning nutrition, cited following the August survey, 42 C.F.R. § 483.25(i)(1), 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.

(i) Nutrition. Based on the comprehensive assessment of a resident, the facility must ensure that a resident--

(1) Maintains acceptable parameters of nutritional status, such as body weight and protein levels, unless the resident's clinical condition demonstrates that this is not possible..

42 C.F.R. § 483.25(i)(1); HCFA Ex. 1 at 50.

To support the allegation that Petitioner failed to comply with this requirement, the situation of resident 9 is detailed at tag F 325 on the HCFA 2567. HCFA Ex. 1 at 50-54.

The preponderance of the evidence shows that Petitioner was in substantial compliance with participation requirements specified in 42 C.F.R. § 483.25(i)(1) regarding nutrition, at the time of the August 1998 survey.

Resident 9 had a history of throat cancer, anxiety disorder, and depression, among other things. The cancer recurred and was determined to have metastasized and was non-treatable. P. Ex. 130-140; Tr. at 759-760. The evidence showed that resident 9 essentially stopped eating after his throat cancer recurred. Tr. at 706. Resident 9 persistently refused to eat when offered food by his family, the staff, and even the psychologist, Dr. Israel. Tr. at 706. Resident 9 was described by Ms. Shipe, Petitioner's social worker, as extremely depressed and often remarking that he just wanted to die. Tr. at 740. Dr. Patel, an internist and resident 9's attending physician, testified that the throat cancer was gradually closing up the food pipe and therefore the patient's food intake declined. Resident 9's condition caused him difficulty in taking fluids as well as solids. Tr. at 760, 762. Dr. Patel discussed the option of providing the resident with a feeding tube, however, resident 9's family refused this option. Tr. at 760. Even the surveyor conceded that the care plan and interventions provided by Petitioner were good.

Tr. at 65. I take particular note of Dr. Patel's opinion that resident 9 lived for a longer period of time in the nursing home than Dr. Patel had expected. Tr. at 763.

HCFA argues that even before the throat cancer reoccurred in July 1998, Petitioner failed to adequately provide the necessary care and services to maintain resident 9's nutritional parameters. Ms. Casey testified that although the care plan regarding nutrition was good, she was concerned with how the care plan was being implemented. Her concern centered on the responses of the staff at Petitioner, in that the staff continually asked Ms. Casey if she was aware that this resident had throat cancer. Tr. at 65, 67. Her testimony gave the impression that she felt the staff had given up on this resident and therefore the staff was not intervening aggressively enough. Tr. at 109. However, the record indicates that resident 9 was receiving interventions by the nursing staff, the dietitian, the social worker, and the psychologist. P. Ex. 130-137; Tr. at 119, 761-763. In addition, although the throat cancer did not reoccur until some time in July 1998, resident 9 was depressed despite medications and refusing to eat prior to the reoccurrence of the cancer. P. Ex. 59; Tr. at 962. As noted above, the surveyor conceded that the care plan was good and Dr. Patel's opinion was that this resident lived longer than expected.

In light of this evidence, I find that the resident's condition was such that it was not possible to maintain nutritional parameters for resident 9 and that Petitioner was in substantial compliance with participation requirements as to tag F 325.

H. Incontinence. A quality of care regulation subsection, concerning incontinence, cited following the August survey, 42 C.F.R. § 483.25(d)(2), 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.

(d) Urinary incontinence. Based on the comprehensive assessment of a resident, the facility must ensure that --

(2) A resident who is incontinent of bladder receives appropriate treatment and services to prevent urinary tract infections and to restore as much normal bladder function as possible.

42 C.F.R. § 483.25(d)(2); HCFA Ex. 1 at 44.

To support the allegation that Petitioner failed to comply with this requirement, the situations of residents 8 and 15 are detailed at tag F 316 on the HCFA 2567. HCFA Ex. 1 at 44-47.

The preponderance of the evidence shows that Petitioner was in substantial compliance with participation requirements specified in 42 C.F.R. § 483.25(d)(2) regarding incontinence, at the time of the August 1998 survey.

Resident 8 was assessed as being incontinent of both bowel and bladder. HCFA Ex. 1 at 45. On August 3, 1998, the surveyor, Ms. Stone, observed resident 8 at 11:00 a.m. and smelled the odor of urine and at 11:30 a.m., when the resident had been returned to her room, it was determined that the resident was soaked with urine. HCFA Ex. 1 at 45. Ms. Stone testified that the CNA in charge of caring for resident 8 told her that the CNA had changed resident 8 between 7:30 a.m. and 8:00 a.m. that morning. HCFA Ex. 1 at 45; HCFA Ex. 54 at 10-11. Resident 8's care plan addresses the problem of incontinence and states that the resident will be checked every two hours for incontinence. HCFA Ex. 25 at 10. HCFA alleges that the it was more than three and one-half hours since resident 8 had been checked or changed.

Petitioner suggests that someone else, other than the CNA assigned to resident 8, could have checked resident 8 sometime between 8:00 a.m. and 11:30 a.m. Tr. at 952. However, Petitioner did not present any evidence or witnesses to show that this in fact occurred as regards resident 8. Petitioner also argues that since HCFA is not alleging that Petitioner failed to provide services to restore as much normal bladder function as possible, then HCFA must be claiming that resident 8 was exposed to an increased risk of urinary tract infections because she was wet for a longer period of time than the care plan calls for. P. Br. at 37-38. I agree. No where in the 2567, does HCFA state that this deficiency has anything to do with restoring normal bladder function. In fact, the 2567 does not even refer to an increased risk of urinary tract infections. The 2567 merely states that, "[t]he facility failed to ensure that the resident who was incontinent of bladder received the appropriate services to prevent the resident from being wet and having an odor of urine." HCFA Ex. 1 at 46. Petitioner did present evidence that resident 8 had not suffered any urinary tract infections or pressure sores. P. Ex. 112-120. In addition, the 2567 states that the resident had not been checked or changed for at least three hours which was contrary to the care plan that stated the resident be checked every two hours.

The basis of this deficiency seems to be that Petitioner failed to follow its own policy of checking patients every two hours for incontinence. HCFA failed to show any standard of care that requires two-hour checks of incontinent residents. Both Dr. Crosier, a surveyor, and Dr. Vranian, Petitioner's medical director, testified that there was no standard that they knew of pertaining to this problem. Tr. at 337, 388-389. I find that absent a standard of care that requires checking incontinent patients every two hours, Petitioner's failure to follow its own policy is not a deficiency. I find that the situation regarding resident 8 is not a deficiency as stated under the regulations. Merely being wet or having an odor of urine, by itself, is not a violation of the regulations.

Dr. Crosier found resident 15 to be wet, on August 7, 1998, at 10:10 a.m. Dr. Crosier also testified that he smelled a strong odor of urine and he estimated that resident 15 had been wet for about 30 minutes. Resident 15 was last checked at 7:30 a.m., which was two hours and forty minutes earlier, according to the CNA in charge. HCFA Ex. 49 at 10. The CNA had come into the room at 10:10 a.m. in order to check the resident. Tr. at 294. The CNA told Dr. Crosier that Petitioner tries to check incontinent residents every two hours. Tr. at 294. Evidence was presented that one can not accurately estimate the amount of time someone has been wet by the odor of urine. Tr. at 412. Evidence was also presented that even though resident 15, as resident 8 above, had been incontinent for a long time, he did not have a history of urinary track infection or skin breakdowns. P. Ex. 113-116, 118, 119. For the reasons mentioned above in Part IG, relating to resident 8, I find that the situation regarding resident 15 is not a deficiency as stated under the regulations.

II. Resident assessment.

Care plans are addressed by the regulation entitled "Resident assessment." The regulation subsection, concerning care plans, cited following the August survey, 42 C.F.R. § 483.20(k),⁽⁹⁾ states:

42 C.F.R. § 483.20 Resident assessment.
The facility must conduct initially and periodically a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity.

. . . .

(k) Comprehensive care plans. (1) The facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment. The care plan must describer (sic) the following--

(i) The services that are to be furnished to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under § 483.25; and

(ii) Any services that would otherwise be required under § 483.25 but are not provided due to the resident's exercise of rights under § 483.10, including the right to refuse treatment under § 83.10(b)(4).

(2) A comprehensive care plan must be--

(i) Developed within 7 days after completion of the comprehensive assessment;

(ii) Prepared by an interdisciplinary team, that includes the attending physician, a registered nurse with responsibility for the resident, and other appropriate staff in disciplines as determined by the resident's needs, and, to the extent practicable, the participation of the resident, the resident's family or the resident's legal representative; and

(iii) Periodically reviewed and revised by a team of qualified persons after each assessment.

Under the regulations, a care plan must be developed within seven days after completion of the comprehensive assessment. The regulation concerning comprehensive assessments states:

42 C.F.R. § 483.20 Resident assessment.

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

. . . .
(b)Comprehensive assessments.
. . . .

(2) When required. Subject to the timeframes prescribed in § 413.343(b) of this chapter, a facility must conduct a comprehensive assessment of a resident as follows:

(i) Within 14 calendar days after admission, excluding readmissions in which there is no significant change in the resident's physical or mental condition. (For purposes of this section, "readmission" means a return to the facility following a temporary absence for hospitalization or for theraputic leave.)

(ii) Within 14 calendar days after the facility determines, or should have determined, that there has been a significant change in the resident's physical or mental condition. (For purposes of this section, "significant change" means a major decline or improvement in the resident's status that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one area of the resident's health status, and requires interdisciplinary review or revision of the care plan, or both.)

42 C.F.R. § 483.20 (b)(2)(i)-(ii).⁽¹⁰⁾

To support the allegation that Petitioner failed to comply with this requirement, the situations of seven residents are detailed at tag F 279 on the HCFA 2567. The seven residents are R.L. (# 5), E.S. (#4), M.S. (#8), S.A. (#2), M.W. (#14), A.L. (#1), and E.S. (#9). HCFA Ex. 1 at 3-10.

The preponderance of the evidence shows that Petitioner was in substantial compliance with the Medicare participation requirements specified in 42 C.F.R. § 483.20(k), regarding comprehensive care plans, at the time of the August 1998 survey.

Many decisions about a resident's care must be made long before that resident's condition can be assessed (comprehensive assessment) and the care plan created or revised. For example, when a resident is admitted following surgery, the resident's needs for wound care, mobility, nutrition, elimination, and countless other aspects must all be addressed by the staff while the resident's condition is being evaluated. There is no substitute for professional training, judgment, and experience in such situations. Also, there are oral communications, and many papers other than the care plans, that guide the CNAs, such as shift reports, clipboards with assignments, flow sheets, and information posted in resident's rooms. P. Br. at 13.

There is, of course, room for improvement in any care plan, but I find no failure by Petitioner to comply with the regulations. Two things I would have liked to see in Petitioner's care plans, are cross references to separate writings that are included in the care plan but found at different tabs, such as doctor's orders and rehabilitation plans; and, for residents with pressure sores, the requirement for turning and repositioning patients at minimum every two hours.

III. Physician services.

A physician services regulation cited during the August survey states:

42 C.F.R. § 483.40 Physician services
A physician must personally approve in writing a recommendation that an individual be admitted to a facility. Each resident must remain under the care of a physician.

. . . .
(b) Physician visits. The physician must--

(1) Review the resident's total program of care, including medications and treatments, at each visit required by paragraph (c) of this section;

(2) Write, sign, and date progress notes at each visit; and

(3) Sign and date all orders.

(c) Frequency of physicians visits.

(1) The resident must be seen by the physician at least once every 30 days for the first 90 days after admission, and at least once every 60 days thereafter.

42 C.F.R. § 483.40(b)(1)-(3), (c)(1); HCFA Ex. 1 at 59.

To support the allegation that Petitioner failed to comply with this requirement, the situations of resident 7 is detailed at tag F 386 on the HCFA 2567. HCFA Ex. 1 at 59-60.

The preponderance of the evidence shows that Petitioner failed to ensure that resident 7's physician signed and dated all of the orders concerning resident 7, thereby manifesting Petitioner's noncompliance with participation requirements in respect to tag F 386.

Resident 7 was previously discussed in Part IC above. The essence of the deficiency at tag F 386 is that the physician failed to sign and date the orders for resident 7 and to write progress notes for the resident. HCFA Ex. 1 at 59-60. Resident 7 has had several hospital admissions. Resident 7 was readmitted to Petitioner on May 13, 1998 after being hospitalized for Dilantin toxicity. Resident 7 was again admitted to the hospital on June 16, 1998 and readmitted to Petitioner on June 19, 1998. Resident 7 returned to the hospital on July 8, 1998 and was readmitted to Petitioner on July 17, 1998.

Upon a review of resident 7's medical record, a surveyor, Ms. Stone, found that the physician had failed to sign all the orders since May 13, 1998. HCFA Ex. 54 at 19-20; Tr. at 367-368. The surveyor brought this to the attention of Petitioner's staff. The staff subsequently called the physician to come in to sign the orders. The medical record was taken from the surveyor and then returned to her with most of the orders signed. Even after the records were returned to the surveyor, several of the orders remained unsigned. HCFA Ex. 24 at 5-13, 45-46; Tr. at 541. In addition, of the orders that were signed, several remained undated. HCFA Ex. 24 at 5-13, 45-46.

Petitioner does not refute these facts. Rather, Petitioner argues that the physician's first face-to-face visit and thus the requirement to sign his orders, was not yet due under the regulations. Petitioner asserts that an admission occurs each time a resident returns to Petitioner after having gone to the hospital for several days. Petitioner points out that 42 C.F.R. § 483.40(b)(1)-(3) does not specifically say when a physician must sign his orders and argues that I should be guided by the 30-day after admission time period found in 42 C.F.R. § 483.40(c)(1) as to the timing of the physician's signing and dating of his orders. According to Dr. Vranian, a physician may give orders over the telephone and then sign them at his next visit to Petitioner. Tr. at 400-403. Ms. Thurnher also has the same view on this matter. Tr. at 1184-1185, 1198-1199. Petitioner argues that since resident 7 was readmitted, after her last hospitalization, on July 17, 1998, then the signing of the orders that took place on August 4, 1998 was timely. Therefore, Petitioner argues, since there was no violation of a regulation, there can be no deficiency.

HCFA did not present any evidence on an accepted standard of practice concerning the time in which to sign telephone orders. However, even if I accept the 30-day time period from admission to the facility as the time in which to sign telephone orders, HCFA takes the position that resident 7 was in the facility for 30 consecutive days from May 13, 1998, one of the days of admission, until June 16, 1998, and the physician should have signed the orders that were in effect on those dates earlier than August 4, 1998. In addition, HCFA points out, and Petitioner does not deny, that the physician was notified by Petitioner of the unsigned orders, after Petitioner became aware of the problem from the surveyor, and that this prompted the physician to come in. HCFA Br. at 52.

I find merit in HCFA's position. Absent evidence on an accepted standard of practice concerning the time in which a physician must sign telephone orders, I am guided by 42 C.F.R. § 483.40 (c)(1) which states, and even Petitioner argues, that a physician must visit a resident at least once every 30 days in the first 90 days following an admission. I find that resident 7 was admitted to the facility on May 13, 1998, after being hospitalized for Dilantin toxicity. More than 30 days elapsed between May 13, 1998 and June 16, 1998, at which time resident 7 returned to the hospital. Any telephone orders during the May 13 - June 16, 1998 time period should have been signed and dated within 30 days following the May 13, 1998 admission. The unsigned orders from May 13 - June 16, 1998 support a finding of a deficiency under tag F 386.

In addition, some of the orders that remained undated, after the physician's visit of August 4, 1998, date back to mid-May. These orders that remained undated, were undated for almost three months, well in excess of the 30-day after admission time period that Petitioner urges me to accept. These undated orders also support a finding of a deficiency under tag F 386.

The fact that orders after July 17, 1998 were not all signed and dated is not relevant to this deficiency since the physician had until August 17, 1998, after the August survey was concluded, in which to sign these orders.

At the hearing, Petitioner argued that the records of May 13 - June 16, 1998 were closed records because the resident had been discharged from Petitioner to go to the hospital on June 16, 1998 and closed records do not have to have signed orders in them. Tr. at 891. I disagree. The requirement to have signed orders in the medical record became due on June 13, 1998, while the resident was still in the facility and the record was not yet closed. I also disagree with Petitioner's argument that the failure to have signed orders in a closed chart does not reach the level of a potential for more than minimal harm. The potential for more than minimal harm must be assessed at the time the signing should have taken place. On June 13, 1998, no one knew that resident 7 would have fractured her hip and would have required another hospitalization on June 16, 1998. The resident could have remained unvisited by her physician for an indefinite period of time and all her telephone orders could have remained unconfirmed by the physician. Telephone orders are, of course, oral orders and there is a serious risk of misunderstanding, error, or miscommunication. For this reason, a physician's signature is required on all orders to confirm that the orders are correct. Without this confirmation from the physician, who is the source of the order, there is a potential for more than minimal harm to the resident. Therefore, I find that Petitioner was not in substantial compliance as regards tag F 386.

Petitioner was not in substantial compliance with Medicare participation requirements at the time of the August 1998 survey. Consequently, HCFA had the authority to terminate Petitioner's Medicare provider agreement.

1. HCFA' s termination action was, however, enjoined in U. S. District Court.

2. By a stipulation dated October 30, 1998, HCFA agreed that its termination of Petitioner was based on its determination that Petitioner was out of compliance with Medicare requirement for more than six months. HCFA agreed that it would not have terminated Petitioner if substantial compliance had been demonstrated at the August 1998 survey. HCFA agreed to rescind the termination if I were to find that Petitioner was in substantial compliance during the August 1998 survey. Petitioner agreed not to challenge the prior surveys. The parties agreed that I need only review the findings based on the August 1998 survey and that the only issue before me is the termination. Thus, if I find even a single deficiency in the August 1998 survey, which poses a risk of more than minimal harm, then HCFA would have the authority to terminate Petitioner's Medicare agreement.

3. The hand roll is also referred to as a palm protector and as a palm guard. Tr. at 346-347, 831, 1027-1028, 1040, 1065; P. Br. at 41. I refer to this device as a hand roll thoughout this discussion.

4. The surveyors were provided documents from the facility which demonstrate that there were 14 shifts during the month of July 1998, in which resident 8 did not wear the hand roll, abductor, splint, and palm guard as ordered. HCFA Ex. 25 at 11. However, Petitioner offered the identical exhibit, once as P. Ex. 11 and again as P. Ex. 122, which shows differences when compared to the exhibit offered by HCFA as HCFA Ex. 25 at 11. Petitioner's exhibits show only two shifts in which resident 8 did not wear the hand roll, abductor, splint, and palm guard as ordered. Deliberately misleading alteration of any document was not proved by the evidence. I find that I am unable to draw a useful conclusion from the differences in these documents and I give little weight to the differences in these documents. However, I note that even Petitioner's exhibits show that there were two shifts during July in which resident 8 did not wear the hand roll, abductor, splint, and palm guard as ordered.

5. HCFA withdrew its tag 309 citation regarding the care provided to Resident 25. However, even if HCFA had not withdrawn this citation as regards Resident 25, I would not consider evidence concerning this resident because of the issue of inadequate notice discussed in Part IA above.

6. The Dilantin level of June 14, 1998 was not provided to the surveyors during the survey, nor during the IDR, nor during the prehearing exchange. It was presented for the first time during the hearing. P. Ex. 161; Tr. at 1293.

7. I will not consider any evidence that concerns residents 19, 20, 21, 22, and 24, because of the issue of inadequate notice discussed in Part IA above.

8. The allegation concerning resident 7 under F 329 was withdrawn by HCFA during the hearing.

9. The August survey cited 42 C.F.R. § 483.20 (d) which was redesignated as 42 C.F.R. § 483.20 (k). 62 Fed. Reg. 67174, 67210.

10. In § 483.20, paragraph (b) was revised as shown above. 62 Fed. Reg. 67174, 67211. The effective date of the revision to § 483.20(b) was March 23, 1998. Subsequently, in § 483.20, the introductory text to paragragh (b) (2) was revised as shown above. 63 Fed. Reg. 53301, 53307. The effective date of the revision to the introductory text to paragraph (b)(2) was July 1, 1998.