Petitioner, the Warren N. Barr Pavilion of Illinois Masonic Medical Center (IMMC), is a skilled nursing facility dually certified for participation in the Medicare and Medicaid programs. All such certified long term care facilities must undergo "standard" surveys within 15-month intervals to establish their compliance with program participation requirements. 42 C.F.R. � 488.308(a).⁽¹⁾ When a facility is found to be out of substantial compliance⁽²⁾ with program requirements during a standard survey, the facility may be required to undergo resurveys (or "follow-up" surveys) as often as necessary, if it wishes to show that it has corrected the cited deficiencies and is now in compliance. 42 C.F.R. � 488.308(c).

Standard surveys and follow-up surveys of dually certified long-term care facilities are conducted by state agencies. 42 C.F.R. � 488.330. The state agencies certify the compliance or noncompliance of such facilities, subject to the approval of HCFA. 42 C.F.R. � 488.330(a)(1)(C). A certification of noncompliance requires the imposition of an enforcement action against the responsible facility. 42 C.F.R. � 488.330(b)(2). The enforcement action may be an alternative remedy provided by 42 C.F.R. Section 488, subpart F. 42 C.F.R. � 488.330(b)(2)(ii).

In the foregoing context, Petitioner underwent one standard survey during April of 1997, as well as a follow-up survey during each of the two subsequent months. The Illinois Department of Public Health (IDPH) found Petitioner out of substantial compliance with program requirements during the standard survey of April, 1997. The IDPH also found that Petitioner continued to be out of compliance during the first follow-up survey of May, 1997. When the second follow-up survey was conducted during June of 1997, the IDPH certified that Petitioner had resumed compliance with all program requirements as of June 25, 1997.

Based on the survey results, HCFA imposed a civil money penalty against Petitioner in the amount of $50 per day, from April 3, 1997 through June 24, 1997.

Petitioner timely exercised its right to contest the survey findings which had resulted in the imposition of the CMP enforcement remedy. See 42 C.F.R. � 498.3(b)(12). The case was assigned to me for adjudication. During the in-person hearing held in Chicago, Illinois, each party presented the testimony of two witnesses. The following documents were admitted into evidence:

-- HCFA's Exhibits (HCFA Ex.) 1 through 6, 9, 12, 13, 17, 20 through 24, 29, 31, and 32;⁽³⁾

-- Petitioner's Exhibits (P. Ex.) 10 and 12.⁽⁴⁾

After the close of the in-person hearing and the issuance of the hearing transcript, the parties exchanged and filed two sets of post-hearing briefs. These briefs consisted of each party's main brief and reply brief.⁽⁵⁾

Because Petitioner had raised for the first time during hearing a new theory of law and fact concerning one of the surveyed residents, I gave HCFA leave to supplement its evidence on this issue when it filed its post-hearing brief. Tr. 159 - 163; Letter to counsel by direction of ALJ, dated October 14, 1998 (October 14, 1998 Letter Order). I allowed Petitioner to seek leave to supplement its evidence on the same issue, provided that its additional evidence was rebuttal in nature and was not appropriate for presentation during Petitioner's case in chief during the in-person hearing.⁽⁶⁾ October 14, 1998 Letter Order. Under this process, HCFA attached two documents identified as HCFA Supplemental Ex. (HCFA Supp. Ex.) 33 and 34 to its main brief. I have admitted these two additional exhibits into the record.

Accordingly, the dispositive question of fact the parties have placed before me is whether, during the resurvey of May, 1997, Petitioner continued to be out of substantial compliance with the program requirements identified by HCFA during the initial survey of April, 1997. If HCFA succeeds in proving that Petitioner had failed to attain compliance with the relevant requirements by the time of the initial survey, the parties' stipulations would make Petitioner liable for payment of the assessed CMP in the amount of $50 per day from April 3, 1997 through June 24, 1997.⁽⁷⁾ By these same stipulations, if Petitioner proves that it had resumed substantial compliance with the relevant requirements by the resurvey of May, 1997, then Petitioner will not need to pay a CPM for any of the days from April 3 to June 24, 1997, even though a portion of the CMP corresponds to days covered by the uncontested initial survey findings of April, 1997. See Tr. 12.

FINDING OF FACT OR CONCLUSION OF LAW (FFCL) 1: Petitioner cannot be found in substantial compliance during the resurvey unless it has corrected those deficiencies which underlie the noncompliance citations of the initial survey.

A. Requirements of 42 C.F.R. � 488.308(a)

The regulation governing resurveys states as follows:

(c) Other surveys. The survey agency may conduct a survey as frequently as necessary to --

(1) Determine whether a facility complies with the participation requirements; and

(2) Confirm that the facility has corrected deficiencies previously cited.

42 C.F.R. � 488.308(c). Petitioner was aware that the foregoing regulatory provisions are in the conjunctive, apply to the resurvey conducted by IDPH during late May of 1997, and govern the resolution of this action before me. Therefore, Petitioner has made the following assertion as one of its main arguments post hearing:

Warren Bar Corrected the Previously Cited Deficiencies by May 18, and Was in Substantial Compliance on the Date of the Revisit Survey.

P. Br., 21.

Additionally, Petitioner correctly interprets the regulatory provisions as meaning that it cannot be determined to be in compliance during a resurvey unless it has corrected the previously cited deficiencies. This interpretation is evidenced by the following heading for Petitioner's arguments:

Warren Barr Did Correct the Previously Cited Deficiency by May 18, 1997, and Was, Therefore, in Substantial Compliance With the Participation Requirements on the Date of the Revisit Survey.

P. Reply, 3. This interpretation is reflected also by Petitioner's agreement to waive challenge to the noncompliance citations which resulted from the initial survey of April, 1997.⁽⁸⁾

B. The citations of the April survey which resulted in Petitioner's formulation of a plan of correction and the return of IDPH for resurvey in May

Even though Petitioner is not contesting the noncompliance determination from the initial survey of April, 1997, both parties have provided a summary of those survey findings which are important to understanding why, in resurveying Petitioner during May of 1997, the IDPH found that Petitioner remained out of compliance with the general quality of care provision of 42 C.F.R. � 483.25.⁽⁹⁾ Both parties note that, during the initial survey of April, 1997, the noncompliance citation resulted from Petitioner's omissions in the care of its residents, including the facility's failure to obtain accurate nutritional parameters by height and weight for one resident, and its failure to thicken liquids and monitor feeding for two residents who were on "swallowing precautions." P. Br., 5; HCFA Br., 7.

In order to understand the quality of care requirements citation, as well as the facts which were used by HCFA to make its noncompliance determinations from the initial and first resurvey of Petitioner herein, it is necessary to place the broad language of 42 C.F.R. � 483.25 in the context of those specific regulatory requirements which govern Petitioner's obligation to timely and accurately conduct a "comprehensive assessment" and then complete a "comprehensive plan of care" for each resident.

The relevant language of the quality of care regulation is as follows:

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 the plan of care.

42 C.F.R. � 483.25.

The "comprehensive assessment" referenced in 42 C.F.R. � 483.25 is the outcome of a process wherein the facility is obligated to gather accurate information (42 C.F.R. �� 483.20 and 483.20(c)) in a timely manner (42 C.F.R. � 483.20(b)(4) and (5)) concerning each resident's needs in areas such as his nutritional status and nutritional requirements (42 C.F.R. � 483.20(b)(2)). The regulation mandating the use of comprehensive assessments for each resident specifies that the appropriate health care professional, in completing the relevant portion of the assessments, must certify the accuracy of that portion. 42 C.F.R. � 483.20(c)(2). As relevant to this case, the regulation requires also that the facility conduct the assessment no later than 14 days after the date of the resident's admission and promptly after a significant change in the resident's physical or mental condition. 42 C.F.R. � 483.20(b)(4) and (5). The facility must also examine each resident as appropriate (but, in no event, less than once every 3 months) to assure the continued accuracy of the assessment. 42 C.F.R. � 483.20(b)(5).

The "plan of care" referenced in the quality of care regulation, 42 C.F.R. � 483.25, is also defined by other regulatory provisions. The plan of care is related to an assessment in that the results of the comprehensive assessment process are to be used by the facility to "develop, review, and revise the resident's comprehensive plan." 42 C.F.R. � 483.20(b)(6). Additionally, the facility is under an obligation to develop the plan of care to meet the residents' needs that are identified in the comprehensive assessments. 42 C.F.R. � 483.20(d)(1). The plan must specify the services to be furnished "to attain or maintain the resident's highest practicable physical, mental, and psychosocial well-being as required under � 483.25 . . . ." 42 C.F.R. � 483.20(d)(1)(ii). Additionally, the comprehensive care plan must be developed within 7 days after completion of the comprehensive assessment (42 C.F.R. � 483.20(d)(2)(i)) and be periodically reviewed and revised by a team of qualified persons after each assessment (42 C.F.R. � 483.20(d)(2)(iii).

In the context of the foregoing regulatory requirements, Petitioner was found out of compliance with the general quality of care requirements contained in 42 C.F.R. � 483.25, for failing to provide, in accordance with the comprehensive assessment and the plan of care for its residents, the necessary care and services which would enable them to attain and maintain the highest practicable physical, mental, and psychosocial well-being.

In its brief, HCFA explains the quality of care citation which resulted from Petitioner's failure to obtain accurate nutritional parameters for its resident (identified as R9 during the initial survey). See HCFA Br., 7. Petitioner does not dispute HCFA's conclusion that Petitioner was unable to complete a nutritional assessment for R9 upon his admission, as specifically ordered by R9's treating physician. Petitioner's inability to complete the nutritional assessment as specifically directed by this resident's physician was caused by its dietician's doubts concerning the accuracy of the height and weight recorded by Petitioner's staff for the resident. Id. at 7 - 8. According to HCFA, Petitioner did not weigh R9 until some time after the initial on-site survey was completed on April 3, 1997. Id. at 8.⁽¹⁰⁾

As for those residents on "swallowing precautions" (R23 and R31) mentioned in the report of the initial survey, both of those residents had physician's orders for Petitioner to thicken the liquids that are fed to them. The April, 1997 survey report was introduced into evidence by HCFA without objections from Petitioner. Tr. 5 - 6. The survey report containing the following uncontested findings concerning R23:

R23 admitted 3/23/97 with post CVA and pneumonia, had been on tube feeding until orders were changed to puree with ground meat and nectar thick liquids. Surveyor observed that R23 had a water pitcher at bedside with unthickened water. A cup of liquid left over from breakfast was noted to be pudding thick instead of nectar. When this was presented to E14 on 4/2/97 she stated that water given with meds was also unthickened and that the resident was merely given 5cc of water to "wash down her medications." Interview with R23 done on 4/2/97 indicated that facility was not consistently thickening her fluids as per MD order. There were no swallowing precautions posted on 4/2/97 when observed by E14 and Surveyor.

HCFA Ex. 1 at 5 - 6. The survey report contains also these uncontested findings concerning R31:

R31 admitted 2/97 and is also on swallowing precautions post CVA with hemiplegia. Survey observed a can of strawberry Ensure at bedside which was not thickened as per MD orders to nectar on 4/2/97 This was pointed out to team RN who thickened this liquid. Later on 4/2/97 lunch observation, Surveyor observed that R31 was left alone in room to eat lunch even though there was a swallowing precaution posted to indicate that this resident must "swallow twice, use chin tuck and eat small bites." The lunch served was not in accordance to the menu and consisted of a dinner roll, two dry cookies, and a peach on a bed of lettuce. This resident was offered no supervision at meal time.

HCFA Ex. 1 at 6.

Petitioner acknowledges that, in response to the foregoing quality of care citations from the April, 1997 survey, it committed to instituting a plan of correction and to complete it by May 18, 1997. P. Br., 5 - 6. As relevant to its failure to obtain accurate height and weight measurements for residents, Petitioner's plan committed to providing in-service training to its staff on obtaining height and weight for residents, following physicians' orders, and using thickened liquids and monitoring for residents on swallowing precautions. P. Br., 5; HCFA Ex. 1 at 1. Additionally, Petitioner's plan of correction included the following provisions:

The R.D. [Registered Dietician] will be responsible for ensuring an accurate weight is recorded on the medical record [for R9]. Monthly chart audits will be conducted by the Food Service Director to monitor compliance and reports will be made to the Performance Improvement Committee.

In addition, the nursing staff will conduct an audit 24 hours after admission. The admitting height and weight will be part of this audit. The Director of Nursing will review for compliance and report to the Performance Improvement Committee the results.

HCFA Ex. 1 at 2.

As for correcting the omissions concerning its care of residents who had been placed on "swallowing precautions" by their physician, Petitioner represented in its plan that:

E14 [the staff member who provided care to R23] was disciplined and re-inserviced on protocols for patients on thickened liquids. Dietary will now provide thickened liquids in commercially prepared consistencies. .... Swallowing precautions will be posted above the bed. The nursing supervisor will check this daily. The Director of Nursing will monitor for compliance and report results to the Performance Improvement Committee.

R31 - The family and the private duty staff were inserviced on her need for all liquids to be thickened. .... Only commercially prepared thickened liquids will be utilized for patients. Patients on swallowing precautions are to eat in the lounge unless one to one supervision is provided in the room at meal time. . . . All residents on thickened liquids have been reviewed and precautions posted above their beds.

HCFA Ex. 1 at 3 - 4.

On May 28, 1997, 10 days after Petitioner was to have completed the corrective actions in its plan of correction, the IDPH conducted a resurvey to verify Petitioner's allegations that it had corrected the previously cited noncompliance problems. The surveyors, as well as HCFA, concluded that Petitioner had not yet attained compliance with the regulatory provisions of 42 C.F.R. � 483.25. They based their conclusions on their evaluation of the care rendered to two residents: Ethel K. and Jan H. Their findings, as discussed below, indicate that no accurate weight had been taken for Ethel K despite Petitioner's efforts, such as providing re-training for its staff and making its Registered Dietician responsible for ensuring the accuracy of weight and height measurements. Similarly, their findings indicate also that, despite having posted a "swallowing precaution" over Jan H.'s bed as required by the corrective actions specified in its plan, Petitioner did not provide to Jan H. the thickened liquid or the supervision also required by other portions of its plan.

FFCL 2: The completion of a plan of correction as written is not dispositive of whether prior noncompliance with cited requirements have been successfully eliminated.

Petitioner is correct in noting the relevancy of the plan of correction it had submitted following the initial, April, 1997, survey. See, e.g., P. Reply, 3. The IDPH had given Petitioner the option of submitting a plan of correction containing certain required information, or be at risk for having enforcement remedies imposed immediately on the basis of the results from the first survey. HCFA Ex. 2. Petitioner chose to submit a plan of correction. Therefore, Petitioner was required to set forth in its plan components which included:

1. What corrective action(s) will be taken for those residents found to have been affected by the deficient practice;

2. How the facility will identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken;

3. What measures will be put into place or what systemic changes will be made to ensure that the deficient practice does not recur . . . .

HCFA Ex. 2 at 1 - 2. Additionally, the IDPH specified that the deadline for Petitioner to complete its corrections under the plan must be set at "No later than '5/18/97'." HCFA Ex. 2 at 2.

In its efforts to comply with the requirements for preparing a plan of correction that would be acceptable to the government, Petitioner committed to undertake actions which are intended to achieve compliance. HCFA Ex. 1. It committed also to completing its corrective actions by May 18, 1997. Id. It contends in these proceedings that all components of its plan of corrections were in fact completed before May 18, 1997. P. Reply, 3.

However, completion of a plan of correction by the deadline date does not, by itself, demonstrate that the previous citations for noncompliance have been eliminated. As explained in the preamble to the regulations for situations where an enforcement remedy has already been imposed:

When a remedy is lifted for a facility, it is based on that facility's substantial compliance with the requirements, not on the facility's adherence to its plan of correction. The health or safety of a resident could be jeopardized by a situation in which a plan of correction was followed but the facility was still not in substantial compliance with the participation requirements.

59 Fed. Reg. 56,203 (Nov. 10, 1994). There is no indication in the preamble or the regulations themselves that, if remedies have not yet been imposed, mere adherence to a plan of correction would automatically eliminate concerns for residents' well-being. Concerns for residents' well-being underlie the entire survey process and each resultant finding of noncompliance. See, 42 C.F.R. �� 488.404, 488.406.

The concerns for residents' well-being are especially appropriate in the context of this case, where Petitioner had made commitments to undertake certain actions, such as providing additional training its staff members, assigning to its Registered Dietician the responsibility for ensuring that accurate weight and height are recorded for residents, and posting swallowing precautions over residents' beds where appropriate. See, HCFA Ex. 1 at 1 - 4. However, the residents' health needs could remain unmet, and Petitioner's obligations to them could remain unfulfilled under 42 C.F.R. � 483.25, if, for example, the training proved ineffective, the residents' weights were not recorded accurately despite Petitioner's designation of the Registered Dietician as the responsible overseer, or the posting of "swallowing precautions" over residents' bed led to no implementation of those precautions.

Therefore, I conclude that the resurvey team had the authority to look behind Petitioner's allegation of compliance in order to determine whether its staff has, in fact, done what it had committed to do in the written plan of correction, and to resolve the issue of whether Petitioner's efforts have proven successful for the residents' benefit, as intended by the general requirements of 42 C.F.R. � 483.25.

FFCL 3: If there had existed any question as to whether deficiencies for more than one or two residents are needed to affirm HCFA finding of noncompliance under 42 C.F.R. � 483.25, each party has waived presentation of that issue.

For the initial survey of April, 1997, the surveyors made the noncompliance citation for 42 C.F.R. � 483.25 based on their review of the care provided to 30 residents. From that pool of 30 residents, they identified seven (7) residents whose care manifested deficiencies which amounted to noncompliance. Thereafter, during the first follow-up survey of May, 1997, in focusing on the status of Petitioner's voluntary remediation efforts and its alleged resumption of compliance with 42 C.F.R. � 483.25, the IDPH reviewed the care provided to 11 residents. HCFA and the surveyors used the care provided to two residents to support the finding that Petitioner remained out of compliance with the general requirements of 42 C.F.R. � 483.25.

Neither prior to, nor during the hearing, did Petitioner challenge the sample size used in the May resurvey. It did not allege that the sample size or the sample selection protocol used during the May resurvey were contrary to established survey procedures or otherwise improper. Nor did Petitioner argue or attempt to demonstrate that, as a matter of law, findings of deficiencies concerning one or two residents are insufficient for supporting the noncompliance citation at issue. Neither party suggested that the percentage of the residents found to have deficient care was of significance to the outcome of their dispute.⁽¹¹⁾ Both parties addressed only the quality of care disputes concerning these residents.

Nevertheless, I took measures to ascertain whether there existed any disputes between the parties arising solely from the fact that the May resurvey citation concerned only two residents, one of whom Petitioner claims should not have been included because he had private insurance. I gave the parties the opportunity to brief these foregoing matters by including in my October 14, 1998 Letter Order the following instructions:

The parties should include the following matters in their posthearing briefs, with each matter discussed in a separate section:

. . .

(3) Considering only the citations of deficiencies with regard to one resident, can HCFA's determination of noncompliance be affirmed.

October 14, 1998 Letter Order, 1 - 2.

In the posthearing briefs, each party summarized my other two sets of instructions which preceded the one quoted above (P. Br., 2; HCFA Br., 2) and then complied with them. However, the directive quoted above is not even mentioned in any of the posthearing briefs. Accordingly, I have concluded that the parties are in agreement that a noncompliance determination may be adequately established by deficiencies found for one or two residents. In the remainder of the decision, I will review the merits of the facts alleged to support, or not support, HCFA's noncompliance determination.

FFCL 4: HCFA has shown, through the use of Ethel K. as an example, that Petitioner's practices continued to be out of compliance with the requirements of 42 C.F.R. � 483.25 when the resurvey was conducted.

A. HCFA's prima facie showing of noncompliance

There is no dispute that during the initial survey of April, 1997, Ethel K. was given the identifier of R30.⁽¹²⁾ In 1997, this resident was 82 years old. See, e.g., HCFA Ex. 23 at 5.

In the initial survey report, Petitioner's care of Ethel K. was not listed as noncompliant with the general quality of care requirements of 42 C.F.R. � 483.25, or Tag F 309.⁽¹³⁾ However, according to the report for the initial survey, "[t]here was no weight on admission" for this resident. HCFA Ex. 1 at 12.

Ethel K.'s records were audited again during the resurvey of May, 1997, 10 days after Petitioner had allegedly implemented its written plan to ensure that correct weight measurements would be recorded for its residents. As noted previously, the plan of correction had been prepared by Petitioner as a response to the April survey findings that its staff did not weight a resident on repeated occasions, even though his physician had ordered it on the resident's admission in order to evaluate the resident's nutritional needs, and even though the accuracy of the weight recorded in the resident's charts was questioned by the individual who attempted to perform the nutritional assessment. See HCFA Ex. 1 at 4 - 5.

According to the report of the May, 1997 resurvey team (HCFA Ex. 3), Petitioner's records for Ethel K. showed that she was readmitted to Petitioner's facility on March 17, 1997, following open heart surgery and respiratory distress. The "vital statistics" taken by Petitioner's staff on her readmission indicate that she weighed 105.8 pounds on March 17, 1997 and was 5'6" tall. HCFA Ex. 23 at 4.⁽¹⁴⁾ The initial nutritional assessment document completed on March 24, 1997 listed 140 pounds as this resident's weight over the past three months. HCFA Ex. 23 at 3. Her desired weight was listed as 130 to 140 pounds in the same March 24 document. Id.

Then, on March 31, 1997, Petitioner's staff entered 140 pounds onto the MDS (Minimum Data Set) form⁽¹⁵⁾ they completed for Ethel K. See HCFA Ex. 3 at 2. Then another assessment record dated April 7, 1997 listed the weight of 151.8 pounds for this resident. Id. The same weight of 151.8 pounds was again attributed to Ethel K. for April 17, April 23, and April 30, and May 7, 1997. Id.

In the nutritional progress notes dated May 14, the inaccuracy of the weights previously recorded for Ethel K. was noted. Id.; HCFA Ex. 23 at 2. The document indicates that Petitioner's nursing staff subtracted the weight of Ethel K.'s wheelchair (51 pounds) from the previously recorded weight of 152 pounds. Id. Petitioner's nursing staff then recorded 101 pounds as Ethel K.'s body weight for April and May of 1997. Id.

Having noted the foregoing problems in Petitioner's records, one of the surveyors had Petitioner's staff weight Ethel K. in her presence without the wheelchair. When Ethel K. was weighed in the surveyor's presence on May 28, 1997, the surveyor verified a weight of 127.1 pounds. Id.

Relying on the foregoing facts, the IDPH and HCFA concluded that Petitioner's staff had failed to weight Ethel K. until the surveyor insisted that the task be done in her presence on May 28, 1997, and that, therefore, Petitioner did not know Ethel K.'s true body weight for accurately assessing her nutritional needs until May 28, 1997. See HCFA Br., 10.

Patricia Disselhurst, a Registered Dietician who was a member of the May resurvey team, gave testimony at the hearing to explain the importance of having accurate weight measurements for Ethel K. As correctly summarized by Petitioner, Ms. Disselhurst testified that this resident was "'dutifully assessed weekly,' but 'with maybe misinformation' (Tr. 58), and that the assessments were changed based on the different body weights recorded in her chart (Tr. 59)." P. Br., 9.⁽¹⁶⁾ Petitioner also introduced evidence that, each week, Ethel K.'s condition was followed by her physician and Petitioner's Registered Dietician, who communicated her status to the nursing staff. Tr. 153.

On the question of what impact Ethel K.'s weights had on her plan of care, Ms. Disselhurst responded that "the whole plan of care depends" upon whether Ms. K was gaining or losing weight, so that the Facility could determine whether it needed to increase her fluids/nutrition. P. Br., 9 (citing Tr. 64).⁽¹⁷⁾ According to Ms. Disselhurst, the amount of fluids needed by Ethel K. would depend on her weight. P. Br., 9 (citing Tr. 62 - 63). For example, if she weighed 150 pounds, she would need a different amount than if she weighed 105 pounds. Id.

In providing her opinion as a Registered Dietician, Ms. Disselhurst testified also that a good nutritional assessment was needed by Ethel K. because "protein heals, water heals, carbohydrates heal," and this resident was a very sick woman in need of continued healing for her pressure sores and infections. Id. The other witness for HCFA at the hearing, Commander Dorsey LeCompte, R.N., ⁽¹⁸⁾ provided testimony which was consistent with Ms. Disselhurst's opinions. See P. Br., 11 (citing Tr. 125). Commander LeCompte noted also that Ethel K.'s body was "already fighting to heal after a very serious [heart] surgical procedure." Id. For these reasons, both of HCFA's expert witnesses were of the opinion that Ethel K. had been placed at risk for more than minimal harm by Petitioner's preparation of the legally required assessments and care plan with use of inaccurate weight measurements, by Petitioner's changing those assessments on the basis of inaccurate weight measurements, and by Petitioner's inability or failure to use accurate weight information to determine whether and when provisions of its care plan should be modified to help this resident attain her highest practicable level of well-being as soon as possible. See, e.g., Tr. 58 - 59, 62 - 63, 125 - 126.

B. The invalidity of Petitioner's defenses and supporting evidence

Karen Kraker-Urso, Petitioner's vice-president and nursing facility administrator for the past three years, testified also at the hearing and provided more details concerning the seriousness of Ethel K.'s medical condition. According to Petitioner and Ms. Kraker-Urso, Ethel K. was admitted to Petitioner's long term care facility while she was on tube feeding after her heart bypass surgery, suffering from extensive wounds from that surgery, and with open wounds on her leg which were not healing due to her low albumen levels. P. Br., 14 (citing Tr. 153). She was in Petitioner's facility for rehabilitation. Id. Consistent with Ms. Disselhurst's observation that Petitioner was generating an assessment for Ethel K. each week (Tr. 58), Ms. Kraker-Urso testified also that Petitioner's Registered Dietician and the treating physician followed this resident's condition every week (Tr. 153).

Through Ms. Kraker-Urso's testimony, Petitioner admits that the 151 pounds attributed to Ethel K. after her admission was inaccurate. See P. Br., 13; Tr. 154. As correctly found by the resurvey team, Petitioner's method for correcting its mistake was not to re-weigh this resident immediately after the problem was raised in the nutritional records dated May 14, 1997. P. Br., 13 - 14. Instead, Petitioner's staff simply changed Ethel K.'s records ex post facto. Id. In a portion of the"Nutritional Progress Notes" dated May 14, 1997, Petitioner's staff retroactively attributed 101 pounds to Ethel K. for "4/97" and "5/97." HCFA Ex. 23 at 2. Petitioner, with use of Ms. Kraker-Urso's testimony, contends that attributing the weight of 101 pounds to Ethel K. retroactively demonstrates completion of the relevant portions of its plan of correction as drafted, which specified May 18, 1997 as the deadline for retraining its employees and ensuring that correct weight measurements are recorded for its residents. P. Br., 13 - 14.

In apparent defense of the decision not to re-weigh Ethel K. when the problem was identified in mid-May (see, HCFA Ex. 23 at 2), Ms. Kraker-Urso provided the following information:

-- The facility weighs its residents in the first three days of each month. P. Br., 13; Tr. 155.

-- In mid or late May, 1997, Petitioner did not voluntarily re-weigh Ethel K. to determine the accuracy of the 101 pounds attributed to her because the following facts led Petitioner to conclude that the mistake was caused by a Certified Nursing Aide's failure to deduct the weight of this resident's wheelchair:

A. Ms. Kraker-Urso and her staff considered that "the May weight we took was 101" for Ethel K. (Tr. 154);

B. Ms. Kraker-Urso and her staff talked to the aide who weighed Ethel K. (P. Br., 13);

C. Petitioner's engineering staff calibrates the scales for accuracy each week (Tr. 154 - 55);

D. "We know that the staff use the proper technique because they're competency trained on how to do the weights. So when we talked to the aide, that's when we discovered that the weight of the wheelchair had not been deducted from the weight that was recorded." (Tr. 155).

-- Ethel K. had a history of wide fluctuations in her weight due to fluid retention in her abdomen and generalized edema throughout her body, as shown by her weight of 140 pounds in January, 1997⁽¹⁹⁾, an increase of 40 pounds within one and one half months thereafter (to 179.9 pounds by March, 1997), and an increase of 23 pounds within an eight day period in June after the resurvey. See Tr. 153 - 154; P. Br., 14.

I do not find Petitioner's explanations and affirmative arguments to be credible or logically consistent.

I address first Ms. Kraker-Urso's statement that, in concluding that the resident had been weighed with her wheelchair, she and her staff considered that "the May weight we took was 101" for Ethel K. (Tr. 154). There is no weight of 101 pounds which was actually recorded on a date in May preceding the investigative efforts described by Ms. Kraker-Urso. Even if Ms. Kraker-Urso had been referring to the 105.8 pounds that was inserted around the time of her investigation onto the "Vital Statistics" document dated March 17, 1997,⁽²⁰⁾ her reliance on that insertion would reflect patently circular reasoning and does not help establish the validity of her investigation.

Additionally, nothing of record can account for Petitioner's concluding around mid-May that 105.8 pound should have been inserted as Ethel K.'s weight on the "Vital Statistics" form that should have been completed on March 17, 1997. Mathematically, it is impossible to obtain 105.8 pounds by subtracting 51 pounds (the weight of the wheelchair) from any of the other weights recorded by Petitioner. The initial survey found, and Petitioner acknowledges, that Ethel K. was not weighed in March of 1997. Even if I were to assume that the 152 pounds recorded by Petitioner for April and May, 1997 included a wheelchair weighing 51 pounds (see, HCFA Ex. 23 at 1 - 2), subtracting 51 pounds would not have enabled Petitioner to insert 105.8 pounds as Ethel K.'s March vital statistics on or before May 14, 1997, as the result of the investigative efforts and findings described by Ms. Kraker-Urso.

As for Petitioner's decision of mid-May, 1997 to change Ethel K.'s weight for April and May to 101 pounds, the accuracy of that measurement is also not supported by sufficient credible or persuasive evidence. The accuracy of the 101 pounds attributed by Petitioner to Ethel K. turns on several questions: whether this resident had actually been placed on a scale with her wheelchair when Petitioner's staff was supposed to have been weighing her during April and May; whether the 152 pounds previously recorded for this resident was the number shown on the scale when she was placed on it with her wheelchair; whether Petitioner's staff knew how to weight residents properly (with or without wheelchairs) before the in-service training that was instituted as a response to the April survey citations; and whether Petitioner's staff knew how to record the numbers shown on the scale accurately before they received the in-service training provided by Petitioner's plan of correction.

These questions cannot be answered by the fact that Petitioner's engineering staff calibrated the equipment each week. Nor is it logically consistent for Ms. Kraker-Urso to contend that the staff responsible for weighing Ethel K. was "competency trained on how to do weights" (Tr. 155), when relevant in-service training was provided to staff as a part of the plan of correction after those dates when Ethel K. had been allegedly weighed. The staff's need for such training before, during, and after the initial survey of April, 1997 is certainly implied by Petitioner's voluntary commitment to "in-service" its staff on topics such as "obtaining heights and weights" by May 18, 1997. Moreover, Petitioner's very belief that the weight recorded for a resident included a wheelchair of 51 pounds calls into question the competency of the responsible staff member(s). As the witnesses at hearing all acknowledged, it is not difficult to use one's eyes to gauge whether an individual weighs approximately 100 pounds, or approximately 150 pounds. See, e.g., Tr. 69. Therefore, the care givers' attentiveness and capabilities are also brought into doubt by Petitioner's conclusion that its staff members must have recorded and relied on 150 pounds when Ethel K. allegedly weighed only 101 pounds.

Yet, the routine calibration of equipment and the alleged competency of its staff in weighing residents were the only matters specified by Ms. Kraker-Urso to explain her conclusion that attributing 101 pounds to Ethel K. retroactively for April and May. The CNA who is believed to have weighed Ethel K. with her wheelchair was never identified by Petitioner or made available by Petitioner to answer questions under oath. Nor did Ms. Kraker-Urso indicate the types of questions asked of this individual or the answers she received during the internal investigation. Even if I were to assume that the individual told Ms. Kraker-Urso that she had weighed Ethel K. with her wheelchair and then recorded the numbers she saw on the scale (as opposed to having fabricated the numbers or having been careless in reading those numbers, for example), nothing of record enables me to determine whether the individual was telling the truth to her employer, or whether the individual had prevaricated in order to protect her job or to avoid disciplinary proceedings.

Ms. Kraker-Urso had an interest in the outcome of the investigation when she decided to believe that the variations in the recorded weights were caused by the CNA's having weighed Ethel K. with her wheelchair.⁽²¹⁾ She formulated the plan of correction that is alleged to have brought Petitioner back into compliance after the April, 1997 survey. P. Br., 13. That plan of correction makes the Registered Dietician responsible for "ensuring an accurate weight is recorded" (HCFA Ex. 1 at 2), but it leaves unaddressed the practical question of how the Registered Dietician is to ensure such accuracy when it is not practical to expect that she weight all the residents herself, or that the CNAs weight all the residents in the presence of other staff members for verification. Therefore, it is not surprising that Petitioner and Ms. Kraker-Urso should use the circular reasoning that their plan of correction was successful because they reached a conclusion that the recording of an accurate weight for Ethel K. had been accomplished by retroactively subtracting 51 pounds from this resident's March, April, and May 1997 weights without having to re-weighing her.

Nor is there any credible evidence in the record which adequately supports Ms. Kraker-Urso's conclusion that this resident need not be re-weighed until the first three days of the following month, when residents are routinely weighed by Petitioner. As noted above, Ms. Kraker-Urso attributed significance to the fact that subtracting the 51 pounds of the wheelchair resulted in a weight that approximated the amount previously recorded for Ethel K. This approach is illogical, given Ms. Kraker-Urso's observation that this resident has wide fluctuations in weight during short periods of time due to the retention of fluid in her abdomen and other parts of her body. The surveyors noted that Petitioner's records showed this resident as weighing 140 pounds when the MDS form was prepared on March 31, 1997. HCFA Ex. 3. There is also Ms. Kraker-Urso's testimony that Ethel K. had weighed 140 pounds in January of 1997, that her weight increased to 179.9 pounds within 45 days thereafter, and that she gained 23 pounds within an eight-day period during June, 1997. Tr. 153 - 154. Given these swift and significant weight changes, there is no basis for accepting Ms. Kraker-Urso's belief that, if the wheelchair had not been included, the monthly weight taken of Ethel K. without her wheelchair would have remained constant at about 100 pounds for March, April, and May of 1997.

The uncontroverted evidence before me leads to the conclusion that Petitioner did not correct its noncompliant practices and was not providing timely, accurate, and appropriate weighing services to its residents by the time of the May, 1997 resurvey. The example of Ethel K. shows that Petitioner's remediation efforts to attain compliance with 42 C.F.R. � 483.25 were superficial at best and disingenuous at worst. Petitioner's arguments that its omissions towards Ethel K. were inconsequential to her attaining her highest practicable level of well-being are at variance with the fact that Petitioner's own staff thought it necessary to conduct weekly assessments of her with the use of weight information which later proved unreliable.⁽²²⁾ Petitioner was aware that Ethel K. had recent heart surgery, that she had a tendency to retain a great deal of fluids in short periods of time, and that her doctor used medication (Lasix) to rid her of the excess fluids whenever necessary. E.g., Tr. 154. Petitioner also knew of her physician's practice of adjusting this resident's medications dosage to eliminate excess water from her body. Tr. 172. Yet, even after Petitioner realized that the weight information it had attributed to her repeatedly was incorrect, it opted to do what was convenient instead of what was better suited to the needs of this very ill resident in order to have accurate weight measurements for her nutritional assessments and the adjustments of her medication dosages. Therefore, instead of re-weighing Ethel K. immediately upon discovering the erroneous measurements, Petitioner chose to subtract 51 pounds from a previously recorded measurement and not re-weigh her for accuracy because Petitioner's usual time for weighing residents was still weeks away.

It was not until June of 1997, after the first resurvey was completed, that Petitioner began to weigh Ethel K. each week. According to Ms. Kraker-Urso, this resident's weight on June 2 (only 4 days after the weight of 127 pounds was attained in the surveyor's presence) had arisen to 133.1 pounds. Tr. 172. Between June 2 to June 10, the resident's weight increased from 133 pounds to 156 pounds. Id. Then, seven days later, she was back down to 151 pounds, according to Ms. Kraker-Urso. Id. This information added and emphasized by Petitioner (P. Br., 18) also supports the conclusion that Petitioner should have immediately reweighed Ethel K. voluntarily when it questioned the accuracy of its records during mid-May, instead of merely subtracting 51 pounds from a previously recorded number.

Moreover, the noncompliance issue does not turn on whether Ethel K. had manifested outward signs of deterioration, as suggested by Petitioner. See, e.g., Tr. 189. Nor should great deference be given to the conclusions of a physician concerning the quality of Petitioner's services to his patient, as also was suggested by Petitioner. See, P. Br., 24; P. Ex. 10 at 415.⁽²³⁾ The interests of nursing home residents would be poorly served if Petitioner's propositions were accepted in the context of this case. The requirements of the Medicare statutes and regulations are to help the residents improve to the highest practicable level of well-being as soon as possible. Therefore, noncompliance is defined not in terms of actual harm to residents, but as the potential for causing more than minimal harm to the resident's health. In this case, the obligations and liabilities imposed by law are against the certified nursing care facilities, not against the physicians who, along with those facilities, share in the care of patients residing in nursing homes. Here, too, Ethel K.'s physician did not instruct Petitioner to weigh her with her wheelchair, to include the weight of the wheelchair in the weekly assessment, or to refrain from reweighing her immediately for an accurate measurement when the mistake and its cause were suspected.

Applying the general statutory framework and the requirements of the relevant regulation to the facts before me, I find that, but for the intervention of the resurvey team on May 28, 1997, Petitioner would have continued to placed Ethel K.'s health at more than minimal risk of harm by not providing the services which would have enabled her to "attain or maintain the highest practicable physical, mental, and psychosocial well-being, in accordance with the comprehensive assessment and the plan of care." 42 C.F.R. � 483.25. Absent accurate and reliable weight information, Petitioner could not have reviewed or revised this resident's assessments and care plan to improve her condition as expeditiously as possible, as contemplated by the regulations. See also 42 C.F.R. � 483.20.

FFCL 5: HCFA has shown, through the use of Jan H. as an example, that Petitioner's practices continued to be out of compliance with the requirements of 42 C.F.R. � 483.25 when the resurvey was conducted.

A. HCFA's prima facie showing of noncompliance

The same type of superficial corrective measures was reflected in the services provided by Petitioner to Jan H.⁽²⁴⁾ during the May 1997 resurvey in response to the swallowing precautions posted on his bed.

The relevant parts of Petitioner's plan of correction stated that its staff would be "in-serviced" on topics which included "the use of thickened liquids and the monitoring required for patients on swallowing precautions." HCFA Ex. 1 at 1. Petitioner's plan specified also that "[p]atients on swallowing precautions are to eat in the lounge unless one to one supervision is provided in the room at meal time." HCFA Ex. 1 at 3. In accordance with Petitioner's corrective action plan, "[s]wallowing precautions will be posted above the bed" and its "nursing supervisor will check this daily." HCFA Ex. 1 at 3.

The resurvey team found that a resident assessment form completed by Petitioner on May 10, 1997 indicated that Jan H. needed total assistance in eating. HCFA Br., 15 - 16; HCFA Ex. 3 at 4. Ms. Disselhurst testified that a pharyngeal study done on May 19, 1997 for Jan H. stated:

Presented with mild oral stage problem, characterized difficulty masticating soft foods as he tended to swallow soft foods. He had difficulty chewing soft foods and aspirated thin fluids and had multiple swallows to clear solid foods.

Tr. 70. She noted also the following information contained in the same May 19, 1997 report:

The aspiration was complete with very poor to no sensitivity reaction; the patient had silent aspiration; approximately 20 percent of the liquid were aspirated; the chin tuck procedure was attempted with fair results.

Tr. 72.⁽²⁵⁾ During the resurvey, Ms. Disselhurst spoke also to the speech therapist for the facility and was informed that Jan H. had to be observed, that he had been on partial tube feedings, that he eats too fast, and that he is so happy to be eating. Id.

On May 28, 1997, Ms. Disselhusrt noted that, consistent with Petitioner's plan of correction, there was a swallowing precaution sign posted above Jan H.'s bed stating, "Use chin tuck" and "Needs to slow down." See Id.; HCFA Ex. 1 at 3. HCFA does not specifically dispute that Petitioner's nursing supervisor may have been checking for the presence of this sign each day, as also required by its plan of correction. However, HCFA, through one of its witnesses, contends that he was not receiving other required services.

When Ms. Disselhurst observed Jan H. on May 28, 1997, he was not taking his meal in the lounge or receiving one-on-one supervision in his room during his meal, as specified by Petitioner's plan of correction. Instead, he was eating his meal alone in his room, and he was hurrying through his meal because he was scheduled to be transported to the hospital for an appointment. HCFA Br., 10; Tr. 69; HCFA Ex. 3 at 4. Additionally, the consistency of the food (pureed) given to Jan H. for that one meal was not appropriate to the eating restrictions indicated by Petitioner's records or its staff members, according to HCFA. HCFA Br., 11. When Ms. Disselhurst made inquiries with the nurse assigned to his care, the nurse said she was not aware of Jan H.'s need for assistance in eating. Tr. 71 - 72.

Ms. Disselhurst was of the opinion that Petitioner's omissions placed Jan H. at risk for more than minimal harm because he could have choked without supervision and in rushing through his meal for his appointment. Tr. 74 - 76. Commander LeCompte also provided the opinion that Jan H. was placed at risk for aspirating his food by Petitioner's failure to supervise him and by the timing of his meal that day. Tr. 129. Both of these witnesses believed that Petitioner should have delivered the meal to Jan H. earlier on this day, so that he would not feel a need to rush through it in order to be timely for his appointment. Id., Tr. 76.

B. The invalidity of Petitioner's defenses and supporting evidence

To provide a background for its various defenses to HCFA's conclusions concerning the care of Jan H., Petitioner used Ms. Kraker-Urso's testimony to outline this resident's status while at the facility. P. Br., 15.

According to Ms. Kraker-Urso, Jan H. had cancer of the larynx; he experienced an acute episode while at work; while hospitalized, he had a tracheostomy inserted and was begun on tube-feeding. Id., (citing Tr. 157). He was sent to Petitioner's facility to have his trachea removed, to get him on oral food, and to discontinue the tube-feeding. Id. According to Ms. Kraker-Urso, all of the foregoing goals were met by Petitioner. Id. Jan H. had a need for total assistance in eating at the time the MDS assessment form was completed because, at that time, he was on tube-feeding only; later, at the beginning of June, he was upgraded to a general diet. P. Br., 17 (quoting Tr. 168 - 170).

Based primarily on the foregoing information, Petitioner's defenses to the surveyor's observations of May 28, 1997 are as follows:

-- Jan. H. was not a Medicare or Medicaid resident. P. Br., 16, 25 - 28.

-- Jan H. did not wish to eat in the dining room and had exercised his right as a resident to eat in his room. P. Br., 17 (quoting Tr. 168 - 170).

-- The care plan and physician's orders for Jan H. had upgraded his status from being totally dependent on others for eating, so that he would need only verbal guidance at meals. P. Br. 19 (citing Tr. 179).

-- Jan H.'s doctor released him back to work with no restrictions on May 27, 1997. P. Br., 16 (citing Tr. 163).

-- Throughout his stay at Petitioner's facility, Jan H. was alert and oriented, was able to follow instructions, did not require one-on-one supervision all the time, and had been training in using chin tucks. He had not needed total assistance since being taken off of tube feeding. P. Br., 16 - 17 (quoting Tr. 168 - 170).

-- The written swallowing caution placed above Jan H.'s bed was for the staff to provide him with oral cues, and Petitioner's procedures required that these oral cues be given to Jan H. when the meals are delivered to his room. P. Br., 22.

-- The surveyors did not have sufficient information to determine whether the meal was served "late" to Jan H., the time of his appointment, or that the driver responsible for transporting him to his appointment was one of Petitioner's employees. P. Br., 11.

-- Jan H. did not suffer any negative outcome, as is required for a finding of noncompliance. P. Br., 23.

The foregoing contentions, even if true, do not rebut HCFA's showing that Petitioner had continued to be out of compliance with the requirements of 42 C.F.R. � 483.25 as of May 28, 1997.

a. Under the facts of this case, Petitioner's obligation to maintain compliance with Medicare certification requirements is not affected by who pays for the care rendered to Jan H.

The fact that Jan H. was not receiving Medicare or Medicaid benefits does not constitute a defense for Petitioner. During the evidentiary hearing, Petitioner's counsel advised me of his client's legal theory: that the Medicare requirements were inapplicable to Jan H., a "Union 100 patient" (Tr. 158), because Petitioner's facility had three "distinct parts," one of which is "private pay." Tr. 159 - 161.⁽²⁶⁾ Since Petitioner was raising this legal theory for the first time, I established procedures for the parties to flesh out their respective positions on the issue after the witnesses had completed their in-person testimony. Tr. 162 - 163, 196; October 14, 1998 Letter Order.

In accordance with the procedures I had established, HCFA submitted documentary evidence showing that Jan H., although a private pay patient, was in fact occupying a Medicare-certified bed in a Medicare-certified room at the time of the May 1997 resurvey.⁽²⁷⁾ During the evidentiary hearing, Petitioner did not present any evidence as part of its case in chief that Jan H. was occupying a bed in the distinct, "private pay" unit. Nor did Petitioner avail itself of the opportunity provided by my October 14, 1998 Letter Order to seek leave to submit evidence in rebuttal to HCFA's proof concerning Jan H.'s stay in a Medicare-certified bed and room during the relevant time. Its only response of note is the assertion that HCFA's argument that the Medicare regulations governed the care rendered to individuals occupying Medicare-certified beds "would seem to be opposed to HCFA's early position on this matter." P. Reply, 9. HCFA, however, maintains that its position has remained constant. HCFA Reply, 7.

Under these circumstances, I find the uncontested facts before me render inapposite Petitioner's legal theory that the Medicare statutes and regulations do not apply to portions of the facility which are not certified for Medicare participation.

The regulation under consideration, 42 C.F.R. � 483.25, specifically states that "[e]ach resident shall receive and the facility must provide . . . ." None of the Medicare regulations includes a test for determining their applicability on the basis of who is paying for the care provided by the Medicare-certified facility, or whether that care will be paid for at all by anyone. Therefore, the plain meaning of the words in 42 C.F.R. � 483.25 means, at the very minimum, that the mandatory provisions of the regulation apply to residents who occupy Medicare-certified beds in Medicare-certified rooms. Jan H. was such a resident.

As an occupant of a Medicare-certified bed in the portion of a facility that is Medicare-certified, Jan H. was merely a third-party beneficiary of the Medicare certification agreement entered into by Petitioner with HCFA. The agreement is between Petitioner and HCFA. Under this agreement, there can be no real doubt that Petitioner has agreed to maintain compliance with all Medicare laws and regulations at its certified facility or unit, in exchange for the privilege of continued participation in the Medicare program. See, e.g., 42 C.F.R. � 483.1. Petitioner's receipt of reimbursements from the Medicare trust fund for care rendered to Medicare beneficiaries is merely a result of its having entered into the program participation agreement with HCFA. As a matter of law, HCFA's rights against Petitioner under their agreement cannot be altered by Petitioner's decision to care for a non-Medicare patient in a part of the facility that was given Medicare certification on the basis of Petitioner's promise to comply with the Medicare laws and regulations when providing care therein.

Additionally, nothing of record suggests that the terms of Jan H.'s private insurance policy precluded Petitioner from adhering to the Medicare regulations. Nor is there any indication in the record that payments would be denied by Jan H.'s private insurer if Petitioner were to provide to him "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). There is also no logical or evidentiary basis for suspecting that the Medicare-certified bed and room occupied by Jan H. during the resurvey might have been located in a distinct part of the premise which was not certified for Medicare participation.

For all of the foregoing reasons, it is not necessary for me to reach the question posed by Petitioner, which intimates without factual support that Jan H. had been placed in a distinct private-pay unit of the facility. The fact that Petitioner could have, but did not, place Jan H. in its private-pay unit does not enable Petitioner to divest itself of the responsibility to provide to Jan H. the services mandated by 42 C.F.R. � 483.25.

b. There is insufficient evidentiary support for Petitioner's contention that Jan H. chose to eat in his room, as opposed to being taken into the dining room where supervision would have been provided.

Petitioner seeks to create the impression that its staff had attempted to take Jan H. to the dining room where his eating would have been supervised as provided by the plan of correction, but Jan H. had refused this service, thereby causing Ms. Disselhurst to observe him eating unsupervised in his own room on May 28, 1997. P. Br., 17. Petitioner does not contend that there exists any documentation of Jan H.'s alleged refusal of this offer of service, even though such documentation is required to be a part of the resident's comprehensive care plan (42 C.F.R. � 483.20(d)). Instead, Ms. Kraker-Urso asserted in conclusory terms that Jan H. had exercised his right to refuse to be taken into a supervised area for his meals by choosing to eat alone in his own room. This conclusion appears self-serving and is not supported by credible or verifiable evidence.

c. Petitioner's contention that Jan H.'s status was upgraded to "verbal guidance" is unsupported by the evidence of record.

Also to refute the conclusions drawn by HCFA from Petitioner's omission of services, which would appear to be reasonable in light of the assessment records for Jan H. and Petitioner's corrective action plan, Petitioner had Ms. Kraker-Urso testify about the contents of a care plan and physician orders which were prepared for Jan H. P. Br., 19 (citing Tr. 178 - 179, 183). Petitioner made clear during the hearing that it did not wish to offer the care plan or physician orders into evidence. Id.; Tr. 174. It asks me to accept Ms. Kraker-Urso's descriptions of their contents and effects as true. See Tr. 182. HCFA interposed objections going to the weight of testimony describing the contents of documents not of record. Tr. 173 - 174.

Without doubt, Petitioner had the discretion to withhold from my review a copy of those documents which has been relied upon so heavily for its defenses. However, I am not obligated to accept Ms. Kraker-Urso's testimony describing the substance of a care plan or physician orders which Petitioner has chosen not to place into evidence after many, many months of trial preparations. Contrary to Petitioner's argument, her testimony does not have "credibility all on its own." Tr. 182. As previously noted, Ms. Kraker-Urso is neither a neutral "fact witness" nor an impartial expert in these proceedings. There appears to be no good reason for Petitioner's decision to have her describe these allegedly important documents without also placing the documents into evidence. Moreover, she provided some very summary statements in describing the contents of the extra-record physician orders and care plan for Jan H. Tr. 178 - 179. She either provided no dates for those events considered to be significant to Petitioner's defenses (id.), or she provided dates for events which had not yet occurred when Petitioner was resurveyed on May 28, 1997 (e.g., Tr. 170).

d. Petitioner's defense that Jan H. had been discharged for return to work on May 27, 1997 is neither supported by the evidence of record nor legally significant.

Petitioner contends also that on May 27, 1997, Jan H. had been discharged by his physician for return to work without restrictions. Tr. 163. Even if there exists facts of record which would explain Jan H.'s presence in Petitioner's facility during the surveyor's observations on May 28 despite his having been allegedly discharged for work one day earlier, the physician's order of discharge is not in evidence.⁽²⁸⁾ Additionally, what a physician states in a discharge order does not relieve Petitioner from providing services which are necessary "in accordance with the comprehensive assessment and plan of care" (42 C.F.R. � 483.25) while the resident remains in the facility. Petitioner was supposed to have been providing care to Jan H. on May 28, 1997 in accordance with the requirements of 42 C.F.R. � 483.25 whether or not he could have left there the previous day.

In effect, Petitioner is asking me to believe, on the basis of its witness' interpretations of documents not of record (some of which are not even represented to be the assessment records or the care plan mandated by 42 C.F.R. �� 483.20 and 483.25), that Petitioner need not have complied fully with its written corrective action plan or the literal terms of the quality of care regulations in delivering its services to Jan H. on May 28, 1997 because Petitioner knew that he had recovered so well and so rapidly from the swallowing risks indicated in the pharyngeal study of May 19, 1997 that his physician had authorized his returning to work without restrictions on May 27, 1997. Since there is nothing of record to suggest that Jan H.'s work had anything to do with his ability to swallow food, I am unable to accept Petitioner's proposition that being released for returning to work without restrictions on May 27, 1997 meant that, for the days he continued to reside at Petitioner's facility after May 27, he did not need the services appropriate to the swallowing limitations of record. As even Ms. Kraker-Urso indicated in her testimony, it was not until the beginning of June that Jan H.'s condition was upgraded for the consumption of a general diet. See P. Br., 17 (quoting Tr. 168 - 170).

e. Petitioner has created non-issues with its defense that Jan H. did not need total assistance or one-on-one supervision.

Non-issues have been created by Petitioner's efforts to defend its omissions on the basis of Jan H.'s cognitive skills, his ability to perform chin tucks on his own, his lack of need for one-on-one supervision at all times, and the lack of need of total assistance in eating. See P. Br., 16 - 17 (quoting Tr. 167 - 170).

The one-on-one supervision framework comes from Petitioner's own written plan of correction. Petitioner volunteered to make one-on-one supervision available to residents with swallowing precautions whenever they are given their meals in their own room. For the provision of one-on-one supervision, its plan of correction did not mention the use of criteria such as the residents' cognitive skills or the residents' ability to do chin tucks or other procedures on their own. Therefore, there is no flaw in the conclusion that Jan H.'s situation demonstrates that Petitioner did not in fact implement its plan of correction as written.

More significantly, the surveyor's observation was that Jan H. did not receive any supervision or assistance of any duration at any time during the meal of May 28, 1997. The nurse in charge of Jan H.'s care told the surveyor that she was not even aware that he was in need of assistance. These circumstances make inapposite Petitioner's affirmative arguments that Jan H. was not in need of one-on-one supervision or continuous supervision throughout his entire meal, and that he was no longer in need of total assistance in eating after discontinuation of tube feeding. These affirmative arguments leave unaddressed the fact that, on the day of the resurvey, no supervision or assistance of any degree or duration had been provided to Jan H. in any staff-to-resident ratio. If Petitioner had been providing some supervision or assistance to this resident during the days between the pharyngeal study of May 19 and the surveyor's observations of May 28, Petitioner had the opportunity to prove what it had been doing for Jan H. on days other than May 28. Petitioner did not do so.

f. The evidence does not support Petitioner's allegation that its staff had given Jan H. the oral cues that are necessary.

Jan H.'s need for some amount of supervision or assistance during meals is acknowledged by Petitioner's defense that the written swallowing caution placed above his bed was for the staff to provide him with oral cues, and Petitioner's procedures required that these oral cues be given to Jan H. when the meals are delivered to his room. P. Br., 22. There is also evidence that Jan H.'s speech therapist had indicated a correlation between Jan H.'s happiness in eating food after having been on partial tube feeding, and his tendency to eat too fast. Tr. 70. However, neither Petitioner's acknowledgement of Jan H.'s needs, nor its description of what its staff is supposed to do explains why Ms. Disselhurst observed no one giving this resident any degree of supervision or any verbal cue appropriate to the swallowing precaution posted above his bed. The absence of these services is consistent with Ms. Disselhurst's report that the nurse charged with Jan H.'s care was unaware of his need for assistance.

If Petitioner wished to prove the inaccuracy of these observations by Ms. Disselhurst, it could have, for example, identified the staff member who delivered the meal to Jan H. on the day in issue, and make that individual available to answer questions under oath concerning any oral cue given to Jan H. Instead, Petitioner has chosen to imply that an oral cue was in fact given, because Petitioner had a policy for its staff members to do so for Jan H. Even if I were to accept the existence of such a policy, there is still no proof that it had been effectuated by staff for Jan H. On cross-examination, Ms. Kraker-Urso said she did not know for a fact whether the staff member who took the meal tray to Jan H.'s room had given the oral cues. Tr. 177 - 178. She evaded answering HCFA's counsel's question on whether there was any staff member in the room to give Jan H. the oral cues. Tr. 178.⁽²⁹⁾

Here, as in Ethel K.'s situation, there is a critical gap between the beliefs asserted or implied by Petitioner and Petitioner's proof.

g. Petitioner knew or could have determined the period of time during which the driver was likely to pick up Jan H.; therefore, Petitioner's staff could have timed the delivery of Jan H.'s noon meal on May 28, 1997 accordingly to enable him to eat it in a leisurely manner.

As correctly noted by Petitioner, the surveyors did not have sufficient information to determine whether the meal was served "late" to Jan H., the time of his appointment, or whether the driver responsible for transporting him to his appointment was one of Petitioner's employees. P. Br., 11. However, Petitioner's explanations of why Jan H. did not have sufficient time to eat his meal in a leisurely manner on May 28, 1997 supports HCFA's conclusion that Petitioner had placed this resident at risk for aspiration and choking.

According to Petitioner, "[i]t is uncontroverted that the driver who was taking Mr. H to his appointment was considerably late and that he was not an employee of the Facility." P. Reply, 7. Petitioner states that it did not know when the driver would arrive and, therefore, was unable to time the delivery of Jan H.'s meal so that he would have adequate time to enjoy it. Id. Petitioner attributes to "bad luck" the fact that "the driver showed up in the middle of Mr. H's meal." Id.

I have no doubt that Petitioner was unable to anticipate the exact time of the driver's arrival. However, it is inconceivable that Petitioner did not have advanced notice of, or could not have determined in advance, the reasonable range of time during which one of its residents was supposed to leave its premises for a doctor's appointment. A Medicare-certified nursing facility should not, after all, allow its residents to come and go at will, or allow individuals who are not its employees to drive its residents away without prior arrangements with Petitioner. Therefore, even if Petitioner's staff could not have known whether the driver for Jan H. would in fact arrive on time, early, or late, Petitioner knew or could have known the approximate range of time during which to expect the driver's arrival (and, accordingly, the range of time for Jan H.'s departure) in order to time the delivery of Jan H.'s noon meal to him.

My reading of the evidence as well as Petitioner's arguments indicates that no effort had been made to time the delivery of Jan H.'s noon meal with consideration of the driver's likely arrival time and the resident's need to eat slowly due to his swallowing precautions. It appears more likely than not that his meal was delivered at the same time as usual, or with the meals of other residents who did not need to leave for an outside appointment that day. As with Petitioner's decision not to re-weigh Ethel K. before the regularly scheduled weighing dates for all residents, Petitioner's service to Jan H. on the day observed by the surveyor also indicates a disregard for the residents' needs in favor of its staff's convenience and routine. There is not even a hint in the record that doing what it should have for these two residents would have caused a great deal of inconvenience to its staff, required Petitioner to spend a great amount of money, or required deep analysis beyond the capabilities of an average person.

If Petitioner had been mindful of Jan H.'s swallowing restrictions, the risks posed by eating too quickly, and the approximate range of time during which the driver was likely to arrive, Petitioner's staff could have served the meal to Jan H. well in advance of that period. Thus, Petitioner would have enabled Jan H. to have the time to finish his meal slowly, per his swallowing restrictions and avoid the risks of choking or aspiration, even if the driver had arrived as late as he had done on May 28, 1997. Even if the driver had arrived before the likely period of time, Jan H. would have still had the opportunity to finish his meal slowly while the driver waited, because there was no rush to leave early.

In contrast, the actual events of May 28, 1997 show, as represented by Petitioner, that Jan H. had only eaten one half of his meal when the driver, who was considerably late, arrived to take him to his appointment. Petitioner blames the driver for arriving so late and in the middle of Jan H.'s meal. However, if this driver had not arrived so late, Jan H. may not have been served his meal, or he may not have been able to eat even half of it in advance of being asked by the driver to leave for the appointment. Even though the driver's exact arrival was beyond Petitioner's control, Petitioner's own omissions were the major contributing factors for placing Jan H. at increased risk for choking or aspiration during the noon day meal of May 28, 1997.

h. The lack of actual harm to Jan H. does not establish compliance with 42 C.F.R. � 483.25.

For Jan H., Petitioner also elicited Ms. Kraker-Urso's opinions that no noncompliance citation should have been made because Jan H. did not in fact choke at any time during his stay, and because this resident did not exhibit the requisite decline or negative outcome required by 42 C.F.R. � 483.25. Tr. 168 - 170, 189 - 190. I reject these contentions for the reasons previously set forth in addressing this very defense for Ethel K.'s situation. There is no allegation of actual harm to Jan H. Additionally, I note that, in order to accept the lack of decline defense, I would need to conclude that 42 C.F.R. � 483.25 contains no requirement for Petitioner to render services that would enable the resident to "attain" his or her highest practicable level of well-being. I do not do so because acceptance of this defense would be contrary to the content of the regulation.⁽³⁰⁾

For the foregoing reasons, I uphold HCFA's determination of noncompliance and its imposition of the $50 per day CMP against Petitioner, for the period from April 3, 1997 through and including June 24, 1997.

1. "Standard" surveys are those which include the elements specified in 42 C.F.R. � 488.305.

A standard survey is also called an initial survey (because it begins the survey cycle), or a full survey (due to its comprehensive nature). Additionally, a standard survey is sometimes called an "annual survey" because the interval for undergoing such surveys within each state should average 12 months or less. See 42 C.F.R. � 488.308(b).

2. Substantial compliance means "a level of compliance with the requirements of participation such that any identified deficiencies pose no greater risk of resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301.

From time to time in this Decision, I will use "compliance" as an abbreviation for "substantial compliance." Similarly, I will use "noncompliance" to mean the failure to comply substantially with program requirements.

3. All other documents marked with intervening numbers between 1 through 30 were withdrawn by HCFA. Transcript of hearing (Tr.), 5.

4. With the exception of a document marked for identification as P. Ex. 11, Petitioner had withdrawn the remainder of its proposed exhibits. Tr. 6.

I deferred ruling on the admissibility of Petitioner's proposed Exhibit 11 at the outset of the hearing. Instead, I gave Petitioner the opportunity to offer its Exhibit 11 after the commencement of testimony. Tr. 6. HCFA reserved its right to argue its objections to said document until that time. Tr. 6. After hearing the parties' arguments on whether the document should be admitted (Tr. 163 - 166), I excluded Petitioner's proposed Exhibit 11 from the record. Tr. 165 - 166.

5. I will denote Petitioner's main post-hearing brief as "P. Br.," and Petitioner's reply brief as "P. Reply." I will denote HCFA's main post-hearing brief as "HCFA Br.," and its reply brief as "HCFA Reply."

6. Petitioner did not request permission to supplement its evidence.

7. The daily amount of $50 per day is the lowest rate permitted by regulation. 42 C.F.R. � 488.438(b). The $50 per day rate cannot be reduced to zero unless I conclude that Petitioner was in compliance with program requirements. 42 C.F.R. � 488.438(e)(1).

8. Even though the regulation at 42 C.F.R. � 488.308((c)(2) refers to "deficiencies" in general (and Petitioner terms its problems from the April survey as "deficiencies"), the record in

this case leaves no doubt that Petitioner was cited for deficiencies which amounted to noncompliance as a result of the initial survey of April, 1997. The April 1997 survey report shows that a scope and severity (SS) level of "G" had been assigned to the problems identified under 42 C.F.R. � 483.24 or Tag F 309. HCFA Ex. 1 at 1. A notice letter from IDPH explains that "deficiencies at level "D" or above" mean that the facility is not in substantial compliance. HCFA Ex. 2 at 2.

9. The regulation codified at 42 C.F.R. � 483.25 contains general requirements, followed by subsections (a) through (m). Those subsections specify the facility's obligation to ensure against certain problems or consequences for its residents.

Because "Tag F 309" was used to make the citation for the initial April, 1997 survey and the May, 1997 resurvey, I conclude that Petitioner was found to have remained out of compliance with the general requirements of 42 C.F.R. � 483.25. See P. Ex. 9 and HCFA Ex. 1. I base my conclusion on the following instruction to surveyors appearing on the face of the survey reports:

Use F 309 for quality of care deficiencies not covered by 483.25(a) - (m).

P. Ex. 9 at 1; HCFA Ex. 1 at 1.

10. According to the surveyors' report, this 87 year old resident was identified as R9 during the initial survey, and his charts showed the following:

Physician admission orders include nutritional assessment to be done.

On 3/28/97, a nutritional assessment was attempted which "questioned" the accuracy of the height (6'5") and weight charted upon admission of R9. Clinical record review and staff interview indicated no follow up on re-weighing and re-measuring of R9. Interview of E8 [one of Petitioner's staff members] on 4/2/97 at 9:30 a.m. states that she "informed the nurse (E9) taking care of R9 of the need for height and weight to be done again on 3/28/97." On 3/31/97 E8 again told the nurse taking care of R9 that "R9 still needs to be reweighed and remeasured in order to complete an accurate nutritional assessment as ordered by the physician."

Clinical record review and staff interview on 4/2/97 indicates, still no follow up on weight and height of R9. Surveyor brought this to the attention of E2 who asked a CNA to reweigh R9 which was 165 lbs..[sic] The height still remained undone as of 4/3/97.

HCFA Ex. 1 at 4 - 5.

11. During the initial survey, approximately 23%, or 1 out of 4.3 residents, of those sampled were found to have received the deficient care which resulted in the noncompliance finding.

During the May resurvey, approximately 29%, or 1 out of 3.5 residents, of those sampled were found to have received the deficient care which resulted in the noncompliance finding.

12. For the resurvey of May, 1997, the surveyors gave Ethel K. the identifier of R9. Tr. 32. As noted above, another resident (a male) had been assigned the R9 identifier for the initial survey in April.

13. During the initial survey, the problems with Ethel K.'s care were placed under Tag F 322, or 42 C.F.R. � 483.25(g)(2), which pertains to those services which should be rendered to residents being fed by naso-gastric or gastronomy tube. HCFA Ex. 1 at 11.

14. Near the close of the evidentiary hearing, Petitioner's counsel acknowledged that no weight had been placed onto the "Vital Statistics" form showing a completion date of March 17, 1997. Tr. 193 (referring to HCFA Ex. 31 at 9). Subsequently, for reasons detailed in this Decision, Petitioner inserted into its March 17, 1997 document the weight of 105.8 pounds for Ethel

K. Tr. 193 (referring to HCFA Ex. 23 at 4).

15. This is a standardized screening form which must be used by Medicare and Medicaid certified facilities in performing the required assessments of its residents. See 42 C.F.R. � 483.20(b).

16. After summarizing Ms. Disselhurst's testimony, Petitioner did not deny that weekly assessments were done for Ethel K., that those assessments were changed weekly, or that

Ethel K.'s weight was relevant to the assessments and changes to them.

17. After summarizing Ms. Disselhurst's testimony, Petitioner did not deny the existence of a plan of care for Ethel K., or that Ethel K.'s weight was relevant to her plan of care.

18. In addition to being a Registered Nurse, Ms. LeCompte also has a Master's degree in Public Health, and she is a Commander in the U.S. Public Health Commission. Tr. 115 - 116. During the time period relevant to this action, she was on assignment with HCFA's Illinois Office. Tr. 116.

19. This was her weight on being hospitalized for heart bypass surgery.

20. Petitioner's counsel had answered "Absolutely," to my question of whether the eight of 105.8 pounds was added "after the facility discovered its error?" Tr. 193; compare HCFA Ex. 31 at 9 (March 17, 1997 "Vital Statistics" form without weight) and HCFA Ex. 23 at 4 (same form dated March 17, 1997 with weight).

21. Petitioner also elicited Ms. Kraker-Urso's opinions as an intermittent surveyor for the long term care division of the Joint Commission on Accreditation of Health Care Organizations. See Tr. 145. While I can readily appreciate her credentials, I do not believe that the Joint Commission would assign her to determine the status of her own employer's compliance. The potential for a biased outcome is too great and too apparent in such a situation. In the context of evaluating the findings made by the IDPH and HCFA against Petitioner, I have not given her opinions as a surveyor much weight given her management position in Petitioner's organization, her participation in many of the decisions at issue, and her obvious interest in the outcome of these proceedings.

22. Petitioner relies on Ms. Kraker-Urso's opinion that an individual's weight is but a part of the information needed for a nutritional assessment. P. Br., 24. However, she never expressed the opinion that accurate weight measurements are unnecessary, or that the needs of an individual with Ethel K.'s fluctuating weight and other medical problems should be assessed without reference to accurate weight measurements.

23. Dr. Steven Lorsch, in giving his opinion that Ethel K. had received the necessary care and services, paraphrased only a portion of 42 C.F.R. � 483.25. He did not mention the section of the regulation specifying the delivery of services in accordance with the resident's comprehensive assessment and care plan, or that the requirements for updating or amending the assessments and care plans. P. Ex. 10 at 415.

24. Jan H. was given the identifier of R1 for the May 1997 resurvey. See P. Ex 9 at 3 - 4. He was not among those residents whose care was reviewed during the initial survey.

25. When asked to explain the contents of the report, the witness testified that the pharyngeal study was done by a speech pathologist, and it stated that Jan H.,

when he would swallow, would not complete the swallowing activity, he had sensitivity, and he could aspirate, he could choke, and his lungs would fill up.

Tr. 73. A "chin tuck," to the best of this witness' understanding as a Registered Dietician, involves literally tucking in the chin, which is taught to people with difficulty in swallowing so that they may swallow with the least amount of activity. Id.

26. As also explained by Ms. Kraker-Urso, the facility has a total of 294 licensed beds, of which only 60 were in a "distinct part Medicaid unit," and only 52 were Medicare-certified beds. Tr. 158.

27. HCFA's evidence shows that, when the surveyors conducted their "focused review" on May 28, 1997, Jan H. (also identified as Resident 1 of that resurvey) was occupying one of the two beds in Room 703. HCFA Ex. 13; HCFA Supp. Ex. 34.

According to a survey summary document dated June 4, 1997, Petitioner had 18 rooms containing 52 beds which were Medicare-certified, or "SNF" (skilled nursing facility) beds. HCFA Ex. 33 at 1 (#14). Both of the beds in the room occupied by Jan H., Room 703, were Medicare-certified beds. HCFA Supp. Ex. 33 at 2 (re item "T18": the 18 Medicare-certified rooms listed under #14, "LTC Certified Bed Breakdown," of the preceding page).

HCFA's brief summarizes the substance of the foregoing information. HCFA Br., 10.

28. According to the representations of Petitioner's counsel, this document had been in existence at the time of the May 1997 resurvey but he did not learn of its existence until one week prior to the hearing, when he spoke to Ms. Kraker-Urso. Tr. 165 - 166. I denied Petitioner's motion to admit this document (Petitioner's proposed Exhibit 11) because counsel and his client have been given many months to prepare for hearing, and they were apprised of the prehearing procedures and schedules well in advance. Therefore, their own delays in communicating with one another does not constitute good cause for missing the deadline I had established for filing and exchanging before the hearing all those documents which a party intends to offer into evidence. Tr. 165 - 167. I did not reach the issue of prejudice to HCFA in my consideration because I do not permit any party to disregard my scheduling order without good cause and then place the state of its opponent's readiness under scrutiny by arguing, in effect, that its opponent should have anticipated Petitioner's delay and the disregard of my Order. See Tr. 165.

29. Her response was, "He had already been delivered the tray by the nursing staff." Tr. 178.

30. Ms. Kraker-Urso explained that she read certain instructions to surveyors, which told them to look for declines in resident conditions under 42 C.F.R. � 483.25. Tr. 185 - 186. Therefore, she is of the opinion that no finding of noncompliance may be made under this regulation unless the surveyors have found declines in the resident's condition. Id. If such instructions exist, Ms. Kraker-Urso has misapplied them.

The presence or absence of a decline in a resident's condition is not dispositive of the compliance issue under 42 C.F.R. � 483.25. If, for example, the surveyor finds that a resident had attained his highest practicable level of well-being, but subsequently suffers a decline, then the instructions to surveyors described by Ms. Kraker-Urso would have applicability. The surveyor may then use the fact of the decline to pursue additional inquiries (e.g., was the decline avoidable) in order to determine whether the facility had failed to deliver services in accordance with his plan of care and assessments which would have enabled the resident to maintain his highest level of well-being. If the resident's health was at a low ebb like Ethel K.'s or Jan H.'s during the May 1997 resurvey, the other requirement of the regulation for enabling the resident to attain his highest practicable level of well-being cannot be determined by pursuing the question of whether the resident had experienced declines.