SUBJECT:

Northern Montana Care Center,

Petitioner,

Centers for Medicare & Medicaid

DECISION

Petitioner, Northern Montana Care Center, is a long-term care facility located in Havre, Montana. At all relevant times, Petitioner was certified to participate in the Medicare and Medicaid programs as a provider of services. Petitioner challenges the decision of the Centers for Medicare & Medicaid Services (CMS) ⁽¹⁾ that, from May 29, 1998 through June 22, 1998, Petitioner was not in substantial compliance with program participation requirements. For the reasons discussed below, I affirm CMS's determination that Petitioner was not in compliance with program participation requirements, and I sustain CMS's denial of payment for new admissions (DPNA) from May 29, 1998 through June 22, 1998.

I. BACKGROUND

This case has a lengthy and tangled history before administrative law judges at the Civil Remedies Division of the Departmental Appeals Board. ⁽²⁾ With regard to the highlights of this history: By letter dated May 14, 1998, CMS notified Petitioner that it would be imposing a DPNA as of May 29, 1998, because Petitioner was out of substantial compliance with program participation requirements. ⁽³⁾ On July 13, 1998, Petitioner appealed CMS's determination to the Civil Remedies Division of the Departmental Appeals Board. The case was assigned to Administrative Law Judge Edward D. Steinman. At the request of the parties, the case was stayed through January 8, 1999. The parties then filed separate notices of issues, and Petitioner submitted a proposed stipulation of fact. The parties then briefed a CMS motion to dismiss based on the adequacy of Petitioner's hearing request. Judge Steinman denied CMS's motion to dismiss in his January 28, 2000 Ruling Denying Motion to Dismiss Request for Hearing. On January 31, 2000, the case was reassigned to Administrative Law Judge Cynthia A. Josserand. On May 1, 2000, the case was reassigned to Chief Administrative Law Judge Marion T. Silva. On May 30, 2000, Judge Silva ordered the parties to brief a CMS motion to strike or limit the issues to be decided in the case. On May 15, 2001, Judge Silva ruled on CMS's motion (Ruling on CMS's Motion to Strike or Limit the Issues and Order Directing Exchanges) and ordered the parties to make an exchange of exhibit and witness lists in preparation for hearing. By letter dated June 26, 2001, Judge Silva set a hearing date of September 11, 2001. By motion dated July 13, 2001, Petitioner requested vacating of Judge Silva's May 15, 2001 Ruling. ⁽⁴⁾ By letter dated July 24, 2001, at the parties' request, Judge Silva changed the date of the hearing to October 1, 2001. In a Summary of Rulings dated August 31, 2001, Judge Silva ruled, among other things, with regard to the issues she would be hearing in the case. By Vacation of Hearing Date and Order dated September 6, 2001, Judge Silva granted the parties' request to vacate the hearing date and set dates for prehearing briefing of the issues. On January 30, 2002, CMS filed a response to Petitioner's prehearing brief and a motion for summary judgment, to which Petitioner responded. The case was reassigned to me on June 19, 2002, upon Judge Silva's recusal. By Interim Order dated June 19, 2002, I denied CMS's motion for summary judgment and set a hearing in Helena, Montana, to convene on September 9, 2002.

I held a hearing in this case from September 9, 2002 through September 12, 2002 and took testimony by telephone in the case on September 27, 2002. ⁽⁵⁾ During the hearing I admitted CMS exhibits (CMS Exs.) 1 - 50 ⁽⁶⁾ and Petitioner's exhibits (P. Exs.) 1 - 66. Transcript (Tr.) 27, 28, 290, 525. The parties submitted posthearing briefs (CMS Br. and P. Br.) and responses (CMS R. Br. and P. R. Br.).

II. ISSUE

The only issue in this case is whether Petitioner was out of substantial compliance with at least one participation requirement during the survey which concluded on April 30, 1998. If Petitioner was out of substantial compliance with any participation requirement at this survey, CMS was authorized to impose the DPNA. Thus, if I find Petitioner to be out of compliance with at least one participation requirement, I do not have the authority to alter CMS's choice of DPNA as a remedy.

III. STATUTORY AND REGULATORY BACKGROUND

The Social Security Act (Act) sets forth requirements for long-term care facilities participating in the Medicare and Medicaid programs, and authorizes the Secretary of Health and Human Services (Secretary) to promulgate regulations implementing the statutory provisions. Act, sections 1819 and 1919. The Secretary's regulations governing long-term care facilities are found at 42 C.F.R. Part 483. Regulations governing survey, certification, and enforcement procedures, and regulations governing provider agreements, are found at Parts 488 and 489, respectively; and regulations governing appeals procedures are found at Part 498.

To participate in the Medicare and/or Medicaid programs, a long-term care 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 skilled nursing 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 imposition of a DPNA. The DPNA may be imposed for any deficiency constituting noncompliance and must be imposed where a facility is not in substantial compliance after three months or substandard quality of care has been found on a facility's last three consecutive standard surveys. 42 C.F.R. §§ 488.402(c); 488.408; 488.417(b). See Desert Hospital, DAB No. 1623 (1997).

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

In making my findings in this case I do not address all 13 of the deficiencies identified in the survey report (statement of deficiencies, CMS 2567, or 2567) prepared by the State survey agency (originally issued following the survey on April 30, 1998, and as modified after Informal Dispute Resolution (CMS Ex. 1)). ⁽⁷⁾ Instead, I address Petitioner's failure to comply substantially with four of the requirements cited in the survey report and make no findings as to the remaining alleged deficiencies or to Petitioner's other arguments, as a decision on those issues would not change the outcome of this case and would not further the appropriate use of judicial resources. Moreover, in making my findings, I do not address every resident example cited. CMS is authorized to impose a DPNA if a provider is found to be out of substantial compliance with even a single participation requirement, and it is thus unnecessary for me to make findings on each deficiency or on every resident example identified under that deficiency to support the remedy imposed. See Beechwood Sanitarium, DAB No. 1824, at 19 - 22 (2002).

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.

1. As of the survey ending on April 30, 1998, Petitioner was out of compliance with the participation requirement at 42 C.F.R. § 483.20(b) (referenced as F Tag 272 on the statement of deficiencies from the April 30, 1998 survey).

The section of the regulations governing "Resident assessment" is codified at 42 C.F.R. § 483.20. The regulation provides that a facility must conduct, initially and periodically, a comprehensive, accurate, standardized, reproducible assessment of each resident's functional capacity. The subsection at 42 C.F.R. § 483.20(b) is entitled "Comprehensive assessments." It requires that --

A facility must make a comprehensive assessment of a resident's needs, using the resident assessment instrument (RAI) specified by the State. The assessment must include at least the following information: (i) Identification and demographic information. (ii) Customary routine. (iii) Cognitive patterns. (iv) Communication. (v) Vision. (vi) Mood and behavior patterns. (vii) Psychosocial well-being. (viii) Physical functioning and structural problems. (ix) Continence. (x) Disease diagnoses and health conditions. (xi) Dental and nutritional status. (xii) Skin condition. (xiii) Activity pursuit. (xiv) Medications. (xv) Special treatments and procedures. (xvi) Discharge potential. (xvii) Documentation of summary information regarding the additional assessment performed through the resident assessment protocols. (xviii) Documentation of participation in assessment. The assessment process must include direct observation and communication with the resident, as well as communication with licensed and nonlicensed direct care staff members on all shifts.

The minimum data set (MDS) is used to prepare various assessments, including a 14-day assessment, an annual assessment, and a significant change assessment, which are all comprehensive assessments. They include the RAPs (resident assessment protocols), which are generated by certain identified data elements answered in an MDS assessment. The RAPs allow the individual completing the assessment to pursue a problem or concern a resident is having. See Tr. 40 - 42. Such assessment instruments are important because they allow facility staff to understand a resident physically, emotionally, and socially. Id. at 42.

As reflected in the CMS 2567, CMS alleges that based on surveyor observations, record review, and staff interviews, it was determined that the facility failed to comprehensively assess certain residents. CMS alleges that inaccuracies and incomplete assessments were found; observations and/or interview information was inconsistent with data in the residents' assessment instruments; Petitioner failed to gather further information on triggered RAPs which were needed to comprehensively assess residents' needs or declines in function; restraints were imposed on residents without assessment for risk versus benefit; and references to the source of information used in decision making on the RAPs was not documented. ⁽⁸⁾ CMS Ex. 1, at 21 - 22. I next discuss several resident examples CMS has cited as demonstrating this deficiency.

Resident 8: The CMS 2567 reflects that Resident 8 had a decline in ambulation from her quarterly assessment, dated December 6, 1997, to her annual assessment dated March 4, 1998. Specifically, the 2567 reflects that she was coded as needing extensive assistance with ambulation in December and, in March, she declined to the point where the activity did not occur. However, Resident 8's Activities of Daily Living (ADL) RAP did not include an assessment of or reason for this decline, or what measures had been attempted to prevent it. The 2567 also reflects that Resident 8 had a diagnosis of longstanding dysphagia and was on a specialized swallowing protocol developed by the speech therapist. However, Resident 8 was assessed in the nutritional status RAP to have no difficulty swallowing. Moreover, the assessment did not address whether or not Resident 8 required assistance with feeding. ⁽⁹⁾ CMS Ex. 1, at 22 - 23.

CMS argues in its posthearing brief that the assessments completed for Resident 8 were incomplete, inaccurate, and not a comprehensive assessment of the resident's needs and/or decline in function. I agree.

Regarding CMS's citation concerning Resident 8's dysphagia, CMS notes that although Resident 8 had longstanding dysphagia, the Nutritional Status RAP indicated that she had no difficulty in swallowing. CMS Br. at 16, citing CMS Ex. 1, at 23; CMS Ex. 17, at 21. Ms. Rooney, one of the State survey agency surveyors, testified that the dysphagia was a swallowing problem related to the resident's stroke and that a speech therapist had prescribed a specific protocol for it (which I note to be included as P. Ex. 8, at 29). Ms Rooney also stated that in addition to failing to address the swallowing difficulty, the Nutritional Status RAP did not address whether Resident 8 required assistance with feeding, which the speech therapist had recommended. Tr. 230. Petitioner asserts, however, that Resident 8's need for assistance with feeding was described accurately in her most current comprehensive assessment, P. Ex. 8, at 16 (discussing that the resident ate and drank with a one person physical assist). Moreover, Petitioner argues that Resident 8 was not on a specialized swallowing protocol, but that the speech therapy recommendations regarded her dentures and related to maintaining a functional chew (Tr. 487). Further, Petitioner asserts that Resident 8 was on a mechanical soft diet and did not have an issue with swallowing. P. Br. at 35.

I find that although Resident 8's comprehensive assessment may have noted that Resident 8 needed help in feeding, Resident 8's Nutritional Status RAP did not refer to this or address adequately the resident's swallowing difficulty (which is reflected at P. Ex. 8, at 29, and is entitled "swallowing"). Omitting such key information defeats the purpose of the RAP, which is to more closely pursue a resident's problems, here Resident 8's problems with swallowing and eating, in order to care plan for the resident. While Petitioner may argue that the speech therapy recommendations were limited, the documentation of record shows that the resident did have an issue with swallowing, not limited simply to wearing dentures or maintaining a functional chew, that should have been addressed in the RAP. I note that a Speech-Language-Dysphagia Screen dated December 29, 1997, references Resident 8's difficulty in swallowing (P. Ex. 8, at 27) and includes the therapist's recommendations for "Swallowing." The recommendations specify: Dentures in for meals. Will feed herself but requires assistance . . . reduce her pocketing of food. 1. Her bite sizes should be ½ tsp. Watch she doesn't get them too [?] 2. After a few bites, tell her to take a drink. 3. Remind her to swallow before she [?] more in there. 4. Finish meal with liquids to help clea[n] oral cavity. 5. Check oral cavity. Swab if necessary." P. Ex. 8, at 29.

Regarding CMS's citation concerning Resident 8's decline in ambulation, CMS argues that Resident 8's ADL RAP failed to assess the decline in Resident 8's ambulation. Resident 8 experienced such a serious decline in ambulation that by March, 1998, ambulation no longer occurred. However, the ADL RAP did not include an assessment of or reason for this decline. CMS notes that the summary of the ADL RAP reported Resident 8 had limited potential for improvement and that Alzheimer's disease impacted her ability to perform ADLs. However, CMS asserts that Petitioner answered no in the same RAP to the question as to whether the resident had cognitive factors which impacted ADL functional ability (CMS Ex. 17, at 39). CMS Br. at 16. Petitioner's rebuttal, however, is that Resident 8's change in ambulation was clearly documented in the nurses' notes ( P. Ex. 8, at 48 - 52). Petitioner also asserts that the ADL RAP was completed and accurate as evidenced by the surveyor's finding on the 2567. Moreover, Petitioner asserts that the changes were the unavoidable outcome of the progression of her disease. P. Br. at 35.

After reviewing P. Ex. 8, at 48 - 52, I do not find that the nurses' notes support Petitioner's assertion that a change in ambulation was "clearly noted." Moreover, although Petitioner asserted that the ADL RAP for Resident 8 was complete and accurate, it did not address her decline in ambulation, and it stated that the resident had no cognitive factors impacting ADL functional status, whereas Resident 8 did have such factors, which Petitioner recognizes in its summary of findings. CMS Ex. 17, at 39.

Resident 28: The CMS 2567 reflects that, according to physician progress notes dating back to September 9, 1997, Resident 28 had a longstanding history of edema in her right arm and left leg. The State agency surveyors observed the edema on all days of the survey. Edema was not indicated as a problem condition on her MDS of October, 1997. ⁽¹⁰⁾ CMS Ex. 1, at 23.

CMS argues that Resident 28's assessment was inaccurate, because the resident had edema, which was observed during the survey, but which was not included as a condition in her assessment. CMS Br. at 17, citing Tr. 232. According to Petitioner, the MDS assessment timeframe for observation of edema is seven days. Thus, Petitioner asserts, the surveyor's observation of this resident in April is irrelevant to the question of whether the October 1997 MDS assessment accurately reflected the resident's edema during a seven-day period that occurred six months earlier. I do not find Petitioner's argument persuasive. Instead, I agree with CMS that the MDS completed by a facility is not intended to rely only on information gathered from resident observation, but should also account for information found in a resident's medical records. Here, the edema should have been considered in the resident's assessment. See P. Ex. 52, at 43 (which indicates that a review of a resident's record, including recent physician notes or orders, is to be used in completing the RAI).

Resident 5: The CMS 2567 reflects that Resident 5 was admitted to Petitioner's facility on June 1, 1997, with diagnoses of organic brain syndrome, confusion, forgetfulness, and inability to care for self. CMS asserts that conflicting information was documented in the RAPs and MDS. Specifically, CMS asserts that: (1) Social Service notes dated November 17, 1997, stated, "Resident remains alert and oriented to person." However, the annual MDS dated March 26, 1998, indicated the resident had a problem with long-term memory, but had no problem with short term memory or decision making; (2) The RAP information for the Cognitive Loss/dementia medical factors stated the resident had dementia, but then stated the resident did not have medical condition(s) or diagnosis(es) that impact cognitive status. Also noted in the RAP was that the resident had exhibited verbal expressions of distress and sad, apathetic or anxious appearance in the last 30 days, but the MDS assessment did not indicate this; (3) It was noted in the RAP summary, "Resident has poor eyesight but is able to perform ADLs and there is (sic) no signs of cognitive loss."; (4) It was noted in the RAP summary on psychosocial well-being, "Resident does have diagnosis of dementia that affects cognitive functioning." CMS Ex. 1, at 25 - 26.

Petitioner argues that CMS's findings with regard to this resident represent a lack of knowledge and misunderstanding of the RAP process rather than evidence of substantial noncompliance. Petitioner posits that inconsistencies in responses on RAP summaries are likely the result of the resident's behaviors or condition during a given observation period or occur when interdisciplinary team members completing the RAP come from several different disciplines. Petitioner suggests that, rather than demonstrating substantial noncompliance, the RAP responses noted to be inconsistent with the MDS are actually evidence that Petitioner made proper use of an interdisciplinary team process and appropriately completed the RAP and care planning processes in compliance with the regulations. Petitioner asserts that it has a process in place to assess each resident using the RAI and each resident cited had the process completed. To the extent that there were issues related to implementation of the computer-based record system Petitioner was then undergoing or even a documentation error, Petitioner states there was no negative impact on a resident or the potential for minimal harm to a resident while the computer transition was in progress. P. Br. at 40 - 41.

Petitioner does not deny CMS's findings. Instead, Petitioner has speculated as to why inconsistencies exist in the record. Moreover, Petitioner has not demonstrated that it actually assessed these inconsistencies. Thus, I uphold the deficiency citation here.

2. As of the survey ending on April 30, 1998, Petitioner was out of compliance with the participation requirement at 42 C.F.R. § 483.20(d) (referenced as F Tag 279 on the statement of deficiencies from the April 30, 1998 survey).

The regulation governing "Comprehensive care plans" is codified at 42 C.F.R. § 483.20(d). ⁽¹¹⁾ The regulation provides that a 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 describe: 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 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.

As reflected in the CMS 2567, CMS alleges that based on observations, staff interview, and record review, the facility failed to develop comprehensive care plans for certain residents, as the care plans either did not reflect the care needs of the residents; did not contain specific and measurable goals or approaches for chronic issues, identify problems through assessments, or document who was responsible to follow through with approaches. CMS Ex. 1, at 27 - 28.

Resident 28: The CMS 2567 reflects that Resident 28 was observed on all days of the survey to exhibit problem behaviors. However, CMS stated that Resident 28 had no care plan to address these behaviors. CMS Ex. 1, at 28. In its brief, CMS cites to CMS Ex. 30 to show that Resident 28 wandered and had daily behavioral problems which were ignored in the care plan. Moreover, CMS alleges that the care plan did not specifically address the resident's disruptive behavior and did not provide interventions concerning the disruptive behaviors. CMS Ex. 30, at 38 - 40. My review of the care plan supports CMS's allegation that the care plan did not address Resident 28's behaviors, and Petitioner has not rebutted CMS's evidence and argument.

Resident 6: The CMS 2567 reflects that Resident 6 was screened by physical therapy on March 10, 1998, due to a flexion contracture of the hip. Specific approaches, including passive stretching of hips and knees, were indicated, but these approaches were not on Resident 6's plan of care. CMS Ex. 1, at 28; see CMS Ex. 15, at 4, 14. In its brief, CMS referred to the testimony of Ms. Rooney with regard to why it would be important to have these specific approaches on a care plan. Ms. Rooney stated that, ". . . you would expect that when there's been an assessment by a professional that outlines a care plan that would prevent a problem from becoming a further problem, that in order for all of the staff in the facility to know what to do to prevent that problem, that information would be on the care plan so that they could easily reflect on that document and know how to care for that patient . . . ." Tr. 238.

The suggestions made by physical therapy on March 10, 1998, included that Resident 6: sleep supine and nap during the day; use a wheelchair harness across the upper chest to prevent forward flexion; receive passive stretches to strengthen hips and knees; and be walked while being reminded to stand straight. P. Ex. 6, at 78.

Petitioner asserts that Resident 6 was screened by physical therapy at the request of nursing staff because staff monitored and assessed a change in her gait. Petitioner argues that the physical therapy suggestions were just that -- suggestions -- for restorative orders that it did not have to follow. Petitioner argues three suggestions were implemented and documented in the clinical record, including in the plan of care. Passive stretching was not implemented because it made Resident 6 scream. Instead, Petitioner implemented stretching by positioning Resident 6 in her recliner. They rejected use of a chest harness as too restrictive for Resident 6, so it does not appear on the care plan. Behavioral approaches were included on the care plan and available to the surveyors at the time of the survey and clinical records evidence specific monitoring and interventions. P. Br. at 43 - 44.

Petitioner attempts to have it both ways. First, it asserts that it did not have to implement the physical therapy suggestions, and, second, it says it did implement most of them, but had reasons for not implementing all of them. However, it does not cite to the record concerning where such decision making took place. While Petitioner has asserted that three of the suggestions were implemented, documented, and included in the resident's care plan, my review of the care plan (CMS Ex. 15, at 14; P. Ex. 6, at 18), which is dated January 16, 1998, does not show any updating in March encompassing the physical therapy recommendations. Thus, the physical therapy plan, including the passive stretching of hips and knees, does not appear to have been included in the care plan as of the date of the survey, and it is not clear from the clinical record that what the nurses documented in the nursing progress notes was related to these physical therapy recommendations. See P. Ex. 6, at 36. I agree with Ms. Rooney that in order for staff to know what to do to prevent the flexion problem, information should have been on the care plan in order for facility staff to know how to care for the resident, especially if such staff is in the unit for the first time or working with the resident for the first time. See Tr. 238.

Resident 17: The CMS 2567 reflects that Resident 17 was assessed on all MDSs to have long and short term memory problems and to be severely impaired in decision making. Resident 17's care plan had a goal for this resident to maintain optimal cognitive functions. Resident 17 was also assessed on all MDSs to be totally incontinent. Resident 17's care plan had a goal noting "incontinent episodes will be under control." CMS Ex. 1, at 28.

CMS asserts, based on the record and the testimony of Ms. Rooney (Tr. 239) that Resident 17's care plan did not contain measurable goals regarding her long and short term memory problems. It indicated the goal was to "maintain optimal cognitive function" (CMS Ex. 25, at 23 and also to be found at P. Ex. 17, at 52) which is hard to measure. The interventions in the care plan ("Approach resident in positive manner;" "Autonomy and Dignity. Allow Patient While Providing Needed Care;" and "Consistent Caregiver Provide consistent caregiver" (CMS Ex. 25, at 23)) did not offer any specific, concrete intervention(s) for maintaining optimal cognitive function. In addition, CMS asserts that Resident 17 had been assessed as incontinent (a change from her annual assessment of December 4, 1997 (CMS Ex. 25, at 49)) and a goal of "incontinent episodes will be under control or improve and the skin will remain dry and intact" was indicated. CMS Ex. 25, at 23. However, CMS asserts that the plan contained no clear, measurable plan or interventions to deal with the resident's incontinence (the only intervention listed being "Incontinence. Observe for." Id. CMS cited Ms. Rooney's testimony that "you would hope for something that's real measurable so that staff could understand whether they have met that or not." Tr. 239.

Petitioner argues that behavioral interventions are present on the plan of care developed for Resident 17. Petitioner argues that the finding of noncompliance was inaccurate and reflects a misunderstanding of the care plan process, a misreading of the documentation, or both. Petitioner argues that it is not necessary to develop an individual care plan for each triggered RAP and the interdisciplinary team may choose to combine related issues into a single care plan problem. Here, Petitioner asserts that Resident 17's care plan included specific interventions for her anxiety and anger as well as a need for a consistent caregiver. Further, regarding whether the interventions were measurable, Petitioner asserts that the surveyor did not understand the MDS instrument and coding. Petitioner asserts that the MDS coding is numeric according to standard definitions and criteria developed by CMS, and that the comparison of MDS codes from assessment to assessment thus provides an inherent way to measure any care plan intervention in that domain. Petitioner stated that whether a resident maintained their level of cognitive functioning would be measured by comparing codes in a given section from one assessment to the next in order to determine a decline or improvement in functional areas. P. Br. at 44.

Petitioner misses the point. The deficiency identified here is not that the surveyors will be unable to compare the MDS coding from assessment to assessment, but, instead, that the care plan is devoid of specific interventions to give staff specific and measurable goals and approaches to guide them in the care of this resident. There is nothing in the care plan offering any specific, concrete intervention for maintaining optimal cognitive functioning or a clear, measurable plan or intervention to deal with incontinence.

3. As of the survey ending on April 30, 1998, Petitioner was out of compliance with the participation requirement at 42 C.F.R. § 483.25(h)(1) (referenced as F Tag 323 on the statement of deficiencies from the April 30, 1998 survey).

The regulation governing "Accidents," 42 C.F.R. § 483.25(h)(1), provides:

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

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

The CMS 2567 reflects that, based on observations, staff interviews, and review of staffing levels, Petitioner failed to ensure that the resident environment remained free from potential hazards. The CMS 2567 cited two examples.

Example 1: The CMS 2567 states that:

The facility, which utilizes a central vacuum system, failed to do so in a manner that was safe for residents walking in hallways. The central vacuum system has a long hose that attaches to a receptacle on the wall. On 4/27/98, it was observed that the person vacuuming in a resident room had left an excessive amount of hose laying/flopping in the hallway in the special care unit. Several of the residents in this unit wander independently, and have some unsteadiness in their gait.

On 4/29/98 the vacuum was being utilized in the east hallway. The person utilizing it was in a room on the other side of the hallway with their back toward the door. A long length of hose was laying in the middle of the floor, in a looping fashion in the hallway. The surveyor nearly tripped over the hose as the person utilizing it pulled the hose farther into the room and moving the length of hose lying in the hallway. Several residents with varying levels of gait stability were viewed ambulating in this hallway independently during all days of the survey.

CMS Ex. 1, at 43 - 44.

Petitioner argues that it was in substantial compliance with the regulation. It asserts its in-wall vacuum system is used at least daily to clean the floors and it is expected that surveyors would see the vacuum hose in use and where resident rooms are located. A vacuum must be used to maintain compliance with regulations governing a safe, clean, comfortable and homelike environment. 42. C.F.R. §§ 483.15(h)(1) and 483.70(g)(4). Petitioner asserted that the system has been continuously in use since the building opened in 1997, this survey is the only time a question about its presence has been raised, and there has never been an incident involving a resident, visitor, or staff member, other than the allegations during the April 1998 survey. Petitioner also questioned the testimony of surveyors regarding their observations of the hose, stating there was no documentation in the survey workpapers of the presence of residents where the hose was observed, or the time the observations were made. Moreover, the surveyors did not discuss their observations with staff regarding measures the facility put in place to complete necessary vacuuming of the facility while maintaining a safe environment. Petitioner asserts that the allegation of unsafe conditions was based upon pure speculation. P. Br. at 64 - 65.

The testimony of the surveyors was consistent in their observation that the vacuum might cause a tripping hazard. Tr. 398, 658 - 659. Although Petitioner has indicated that the surveyors did not take into account what measures the facility put into place to complete the necessary vacuuming while maintaining a safe environment, Petitioner did not submit any evidence regarding what those measures were and instead questions the contemporaneous documentation by the surveyors and states that it has been using the system for several years without injury. However, in the absence of any documentary evidence or testimony regarding what Petitioner has done to ensure resident safety, I must agree with the surveyors that a vacuum hose moving about a hall could cause a risk of more than minimal harm to elderly and, perhaps, demented and unsteady residents.

Example 2: The CMS 2567 states that:

During evening rounds between 6:30 and 8 pm on 4/29/98, surveyors found the door to the Beauty Shop open. It was noted that caustic products were left out, this included: 2 full bottles and a partial bottle of Mar-V-Cide a disinfectant. This product was found on the bottom shelf of the metal closet that was not locked. On the label the product was described "hazard to humans and domestic animals. Corrosive, causes eye and skin damage harmful or fatal i[f] swallowed. Beauty Shop Guideline #7 said "the door is to be locked". Additionally, a large variety of hair care products in the area were accessible to residents. Interview with staff demonstrated that the door is occasionally left open as family sometimes wish to provide hair care for individual residents.

CMS Ex. 1, at 44 - 45.

Petitioner argues that the surveyors' observation regarding the Beauty Shop door was a single, isolated finding, raising only speculation, based on hearsay, that this one-time finding, if it existed, posed any hazard. Petitioner asserts that there are two doors to the Beauty Shop, one in an area not immediately accessible to residents. ⁽¹²⁾ Petitioner asserts that neither the survey report nor surveyor workpapers indicates which door was unlocked. Petitioner asserts the Mar-V-Cide was found on the bottom shelf of a closet, not left out. Petitioner's only citation to the record to support these assertions is the affidavit of its employee, Ms. Pollington (P. Ex. 56, at 3), who admits that the beauty shop was left open for family members, and to a surveyor's worksheet which notes an unlocked door (P. Ex. 47, at 1058). P. R. Br. at 5, n.4. Petitioner also asserts that the hearsay statements of staff cannot be verified and provide no legal basis for me to presume that this was more than a single, isolated incident of a performance failure by staff. Petitioner argues that the concept of "substantial compliance" is intended to tolerate a "reasonable degree of imperfection." 59 Fed. Reg. 56,226 (1994); P. Br. at 65 - 66.

I find that there is more than a reasonable degree of imperfection here. The facility's Beauty Shop guideline shows that Petitioner knew an unlocked door leading to caustic and toxic products would be dangerous to residents. Petitioner did not provide any testimony or cite to any evidence I could find to dispute the surveyors' observations that a potentially dangerous substance was left out in an unlocked room accessible to facility residents who might not understand that the substance was a danger to them. Moreover, in an administrative hearing, hearsay testimony is admissible, and Petitioner has provided no testimony nor cited to any evidence to lead me to find not credible the testimony of the surveyors that they were told by facility staff that the beauty shop was left open to families (and thence to residents) despite the Beauty Shop guideline. Thus, I find that this citation is more than a single, isolated incident of a performance failure by staff. The products contained in the Beauty Shop are dangerous to elderly and perhaps demented individuals who may not perceive that danger; leaving these products accessible to these individuals is an accident waiting to happen.

4. As of the survey ending on April 30, 1998, Petitioner was out of compliance with the participation requirement at 42 C.F.R. § 483.20(b) (referenced as F Tag 333 on the statement of deficiencies from the April 30, 1998 survey).

The "Quality of Care" regulations include 42 C.F.R. § 483.25(m)(2), which covers "Medication Errors" and requires that:

The facility must ensure that -- (1) It is free of medication error rates of five percent or greater; and (2) Residents are free of any significant medication errors.

The CMS 2567 states that, based on record review and observation, it was determined that Petitioner failed to give a dose of insulin in the dosage ordered by the physician to Resident 40. Specifically, Resident 40 was to receive Humulin Insulin in 70/30 14 units subcutaneously every morning. It was the routine for this licensed nurse, as evidenced by another insulin administration, to draw up the correct dose in the medication room and, after removing the syringe from the insulin bottle, pull back on the syringe further pulling air into the syringe prior to proceeding to the room. When the nurse entered the room she/he then pushed the plunger up to the correct dose before administering. On April 29, 1998, at 7:30 A.M., when the nurse pushed the plunger up in the room she/he pushed it to the 12 unit mark on the syringe and then pulled back to the 14 unit mark. This was then administered to the resident. The surveyor immediately reported the error to the nursing supervisor of the unit to ensure that the resident had adequate insulin coverage, since only 12 units had been administered. The 2567 also states that sites of administration were not routinely documented following injections. Doing so would allow for proper rotation of sites for routine injections. CMS Ex. 1, at 54 - 55.

CMS asserts that this was a significant medication error, in that a dose of insulin was given of less than the dose prescribed by the resident's physician. The physician had prescribed 14 units of insulin for Resident 40, but the surveyor observed the LPN administer only 12 units. Specifically, Ms. Rooney testified that she observed the nurse pull the correct dosage of insulin into the syringe, "and then she would pull back a bubble of air and then go to the room, push the syringe back to the correct dosage and then give the medication. With the first patient that I saw her give the medication that way she did give the correct dose, but with resident No. 40 . . . When she pushed the plunger in, when she was in the room, she pushed to 12 units instead of 14 units, and then pulled back to 14 when she noticed air and gave the medication. So, in essence, gave only 12 units of insulin versus 14." Tr. 283 - 284. Ms. Rooney also testified that the technique was not a proper administration. Id. at 284. Ms. Rooney also testified that residents generally get their main dose of insulin in the morning, so it is generally "very dangerous" if patients do not get the proper dosage of insulin in the morning. Id. at 285.

Petitioner asserts that it was in substantial compliance with this requirement. Petitioner submitted the affidavit of the resident's attending physician that a two unit deviation, if it did occur, which Petitioner does not concede, would not be a significant drug error for this resident (P. Ex. 57; see also HCFA Pub. 7, State Operations Manual, Rev. 274, Appendix P at PP-129). Further, Petitioner asserts that the alleged facts could not have occurred as described. Petitioner referenced demonstrative evidence offered at the hearing to show that Ms. Rooney's testimony that she saw the medication nurse push the plunger from 14 to 12 units but was unable to stop her from administering the incorrect dosage was not credible. Petitioner states that from the demonstration and the appearance of the insulin syringe, the only way Ms. Rooney could have seen what she described was to have been right next to the medication nurse. In that position she could have indicated an error was about to occur. P. Br. at 81.

The demonstration presented by Petitioner at hearing did not convince me that Ms. Rooney's testimony was not credible. The syringe used in the demonstration was not identical to the syringe used by the nurse giving the injection (Tr. 523, 526) and the argument that Ms. Rooney could not have seen the error is speculative. Moreover, my concern here is not simply that Petitioner's nurse committed an error in this case, but that the technique used could have caused more than minimal harm to other residents.

Moreover, Petitioner never addressed the surveyor's other observation, that it failed to routinely document the sites of medication administration following injections, and that the failure to do so could result in improper rotation of sites for routine injections. Thus, I find CMS's finding to be unrebutted and I uphold it.

5. CMS had a basis to impose a DPNA in this case and I do not have the authority to modify this remedy.

As I stated above in Section III of this decision, if a skilled nursing facility is not in substantial compliance with program requirements, CMS has the authority to impose a DPNA. The DPNA may be imposed for any deficiency constituting noncompliance. I do not have the authority to alter CMS's determination where a basis exists to impose that remedy. Since I have found Petitioner to be out of compliance with the participation requirements above, CMS had a basis upon which to impose a DPNA and I do not have the authority to modify the remedy.

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 labeled as the Health Care Financing Administration or HCFA, I refer to it as the Centers for Medicare & Medicaid Services or CMS.

2. When I began my review of the record in this case, I discovered that the record file did not contain any of the correspondence, submissions, or other documents generated in the case prior to May 15, 2001. However, in a motion to the Appellate Division of the Departmental Appeals Board (Board) (as discussed below), Petitioner provided the Board with a complete copy of the record in the case through June 26, 2001. I am placing a copy of Petitioner's submission in the file as the record file in this case prior to May 15, 2001.

3. The deficiencies upon which the DPNA was based were not at the immediate jeopardy level. The April 30, 1998 survey upon which the deficiencies were based included a finding of immediate jeopardy. However, the immediate jeopardy was removed after a revisit survey on May 6, 1998, but prior to the imposition of the DPNA, and the DPNA was not based on that finding of immediate jeopardy. See Administrative Law Judge Marion T. Silva's Ruling on CMS's Motion To Strike or Limit the Issues and Order Directing Exchanges, dated May 15, 2001.

4. Petitioner also requested review of Judge Silva's May 15, 2001 Ruling by the Board. In a Ruling dated July 26, 2001, the Board declined to hear Petitioner's request, finding that Petitioner's request for review was premature.

5. CMS offered the testimony of Montana Department of Public Health and Human Services (State survey agency) surveyors Kathleen Moran, Janet Collins, Julie Rooney, LaDawn Whiteside Hendricks, Carol Maggitti, and Linda Chapman, and also the testimony of Cecilia Prela, R.Ph. Petitioner offered the testimony of its employees Alice Chambers, India Bauer, and Lori Henderson, and also the testimony of Curtis Kauffmann, M.D. Petitioner has questioned the competence of three of CMS's witnesses: Kathleen Moran, Julie Rooney and Carol Maggitti. These three were trainees who had not yet completed the training and testing program prescribed by the Secretary of Health and Human Services. Petitioner asserts that, due to their inexperience, the State survey agency did not "get [the facts] straight." P. Br. at 7. Petitioner notes that although CMS might argue that the use of these trainees met a regulatory exception (because they were accompanied by qualified surveyors), there is no evidence of oversight or supervision in the record. Id. Thus, Petitioner's argument does not go to whether or not these individuals could take part in the survey but, rather, questions their credibility. Below, I rely on the testimony of these professionally credentialed individuals and their survey findings where such testimony and survey findings are consistent with the regulations, their professional expertise, and the documentary evidence of record.

6. CMS marked its exhibits "D. Ex.," apparent shorthand for Defendant's exhibits. However, in this decision I refer to CMS's exhibits by the acronym "CMS Ex. or Exs."

7. I note here Petitioner's continued objection to the "final 2567" issued by the State survey agency (CMS Ex. 1) as being an accurate reflection of the results of Informal Dispute Resolution (IDR). P. Br. at 9 - 10. However, Petitioner has not furnished evidence or argument that convinces me I cannot rely on this exhibit.

8. While I note all of CMS's general allegations here, again, I do not address every allegation below.

9. The 2567 also reflects that the facility did not do a risk versus benefits analysis with regard to side-rails and asserts that the location of documentation to support assessment data for the RAP reviews was not entered on the RAP summary form. I make no findings regarding this section of the citation.

10. The CMS 2567 also cited the facility for failing to assess the seatbelt noted during the survey. I make no findings regarding this section of the citation.

11. After 1998, 42 C.F.R. § 483.20(d) was recodified and is now cited as § 483.20(k).

12. Petitioner cites as evidence for the two doors, and the inaccessibility of the one, to P. Ex. 35. P. Ex. 35 consists of 105 pages and is a May 12, 1998 letter from the State survey agency accompanied by a copy of the April 30, 1998 statement of deficiencies. This exhibit does not appear to corroborate the statement Petitioner has made.