The Warren N. Barr Pavilion of Illinois Masonic Medical Center (IMMC) appealed the May 26, 1999 decision of Administrative Law Judge (ALJ) Mimi Hwang Leahy upholding the imposition of a civil money penalty (CMP) of $50 per day for the period from April 3, 1997 through June 24, 1997. See IMMC Warren N. Barr Pavilion, DAB CR594 (1999) (ALJ Decision). The ALJ concluded that the Health Care Financing Administration (HCFA) had demonstrated that IMMC was not in substantial compliance with program requirements during the period at issue and that the daily amount of the CMP could not be reduced below $50 since that is the lowest amount permitted by statute. ALJ Decision at 4, n.7, and 35. On appeal, IMMC took exception to three findings of fact and conclusions of law (FFCLs) in the ALJ Decision, numbered 2, 4, and 5, which are set forth below. In essence, one contested FFCL concluded that the fact of completing a plan of correction (POC) as written does not necessarily suffice to establish that noncompliance has been eliminated and two contested FFCLs found that HCFA had demonstrated continued noncompliance based on the use of two specific patients as examples. In addition, IMMC argued that the ALJ had assigned the burden of proof erroneously and erred in weighing the evidence. For the reasons explained below, we conclude that IMMC's arguments are without merit, and we therefore affirm the ALJ Decision.

Background

A survey of IMMC beginning on April 3, 1997 by the State survey agency, the Illinois Department of Public Health (IDPH), found that IMMC was not in substantial compliance with applicable program requirements. ALJ Decision at 2. IMMC thereafter submitted a plan of correction and alleged that substantial compliance would be achieved by May 18, 1997. On May 29, 1997, IDPH conducted a revisit survey and found that IMMC was still not in substantial compliance. In June 1997, IDPH conducted a second revisit and determined that IMMC had resumed substantial compliance with all program requirements as of June 25, 1997. Based on these survey results, HCFA imposed a CMP of $50 per day for the period from April 3, 1997 through June 24, 1997.

The parties stipulated before the ALJ that IMMC did not contest the deficiency findings made in the April 1997 survey and that the CMP would not have been imposed if the May 1997 survey had found substantial compliance. Accordingly, the dispositive question before the ALJ was whether IMMC continued to be out of substantial compliance as of the May 1997 survey. ALJ Decision at 3-4.

The uncontested deficiency findings from the April 1997 survey included noncompliance with general regulatory requirements for providing an adequate quality of care to residents. 42 C.F.R. � 483.25. That regulation provides that each resident should receive "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." The circumstances which led to the uncontested deficiency findings included the facility's inability to complete a nutritional assessment of a resident because of the doubtful accuracy of height and weight records and the facility's failure to provide proper monitoring to two residents on swallowing precautions. See HCFA Ex. 1, at 4-6; ALJ Decision at 7-10.

IMMC was informed after the initial survey that it was required to submit a POC stating, among other things, what corrective actions the facility would take for the specific residents affected by the deficient practice, how other residents who could be affected would be identified and what measures would be taken by the facility to prevent recurrences and monitor compliance. See HCFA Ex. 2, at 1-2. IMMC was also instructed that the POC had to provide a plan to achieve substantial compliance no later than May 18, 1997 and that a revisit would be scheduled once IMMC credibly alleged that compliance was or would be achieved by a specific date. The POC was accepted by IDPH and a revisit was then undertaken to verify compliance.

The surveyors at the May 1997 revisit found that IMMC had not achieved substantial compliance with the requirements of 42 C.F.R. � 483.25. The surveyors based this conclusion on their evaluation of care provided to two residents. As to the first resident, known as Ethel K., the surveyors found that no accurate weight had been recorded. As to the second resident, known as Jan H., the surveyors found that he did not receive required supervision during mealtime despite a posted notice that he was on swallowing precautions.

Standard of Review

Our standard of review of an ALJ decision on a disputed issue of law is whether the ALJ decision is erroneous. Our standard of review on a disputed issue of fact is whether the ALJ decision as to that fact is supported by substantial evidence on the record as a whole.

On appeal, IMMC argued that the ALJ erred in stating the applicable burden of proof. The ALJ issued an order on December 10, 1997 that instructed the parties that HCFA had the initial burden of coming forward with evidence establishing a prima facie case that IMMC was not in substantial compliance with participation requirements and then IMMC had the burden of proving by a preponderance of the evidence on record as a whole that it met the participation requirements at issue. IMMC acknowledged that the ALJ based this order on the appellate decision in Hillman Rehabilitation Center, DAB No. 1611 (1997), but argued that both the order and the appellate decision were unconstitutional.⁽¹⁾ IMMC offered no argument as to why the burden of proof was unconstitutional, but rather stated that the distribution was unlike that applicable to licensees in other administrative fora. IMMC Br. at 9. IMMC provided no examples of the other administrative cases to which it was referring, but noted that the issue was on appeal in a federal court in Illinois in another case. Id.

The ALJ correctly stated and applied the burden of proof articulated in the Hillman case. The reasoning behind that allocation of the burden in cases involving nursing homes receiving federal funds to provide services to Medicare beneficiaries and Medicaid recipients under federal participation requirements is fully set out in DAB No. 1611 and the district court decision affirming that decision and is incorporated by reference here. See generally DAB No. 1611, at 9-25; Hillman Rehabilitation Center v. U.S. Dep't of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999), at 21-38; see also Cross Creek Health Care Center, DAB No. 1665, at 13, n.10. (1998). Based on a thorough examination of the relevant statutory and regulatory provisions and their long-standing interpretation, the Board and the court concluded in Hillman that a facility is entitled to participate in Medicare only when it demonstrates that it is in substantial compliance with the requirements for participation. These requirements are intended to protect the health and safety of the residents who are the beneficiaries of the program. The Board and the court further found that due process was satisfied by requiring HCFA to prove a prima facie case that particular requirements were not met before the facility had to show by a preponderance of the evidence that it was in substantial compliance and by providing a full and fair hearing to the facility on the contested deficiencies.

Furthermore, IMMC did not dispute that it had failed to raise the burden issue before the ALJ, despite having adequate notice in the ALJ's order, issued more than nine months before the hearing. IMMC offered no reason that it could not have raised its arguments before the ALJ. As a matter of judicial economy, it is inappropriate to permit a party to wait until after a hearing and decision below to challenge an order allocating the burden of proof, unless that party can show cause why it could not have raised the same question below at a point in time when the ALJ could have effectively addressed any allegation of error. IMMC had the opportunity to make such a showing here and made no attempt to do so.

We therefore affirm the ALJ's order on the allocation of the burden of proof in this case.

2. Completion of an approved plan of correction does not per se imply correction of prior deficiencies.

The first numbered FFCL to which IMMC excepted read as follows:⁽²⁾

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

ALJ Decision at 10. IMMC argued that all the actions required in its POC were completed by the date set for completion and that its facility must, therefore, be found to be in substantial compliance with the program requirements for which the POC was submitted. IMMC Br. at 2.

IMMC agreed with the ALJ that it could not be found in substantial compliance "unless it has corrected those deficiencies which underlie the noncompliance of the initial survey." IMMC Br. at 2; ALJ Decision at 4. Nevertheless, IMMC argued that fulfilling its POC must be sufficient to demonstrate that the underlying deficiencies have been corrected because, by accepting the POC, HCFA or the state survey agency "explicitly agrees with the Facility that if it complies with the steps set out in the plan . . . then the Facility will correct the cited deficiency." IMMC Br. at 3. IMMC's argument is without merit.

HCFA is authorized to impose a CMP on a facility for the period during which it is found not to be in substantial compliance with program requirements. 42 C.F.R. � 488.440(b). It is well-established that "[m]ere acceptance of a plan of correction does not establish substantial compliance. See, e.g., 42 C.F.R. �� 488.440(h) and 488.454(a)(1), Cross Creek Health Care Center, DAB No. 1665, at 3 (1998)." Beverly Health and Rehabilitation -- Spring Hill, DAB No. 1696 (1999). Regulations specifically require the POC to specify the date "by which those deficiencies will be corrected," not merely the date by which the actions set out in the POC will be taken. 42 C.F.R. � 488.401. Thus, the ALJ correctly held that the facility must establish that substantial compliance has in fact been achieved.⁽³⁾

IMMC agreed that, if it had been found on the revisit to be out of compliance with different participation requirements than those involved in the deficiency findings in the first survey, HCFA could properly impose remedies on the facility. IMMC Br. at 3. However, IMMC contended that the ALJ erred in upholding a remedy based on a determination on revisit that IMMC had not come into compliance on a deficiency cited in the original survey, since IMMC contended that it had followed its POC. Finding noncompliance in such circumstances, according to IMMC, amounted to "second-guessing" and failing to give guidance on how to comply with participation requirements. Id.

IMMC did not cite specifically where HCFA or the State survey agency "explicitly" agreed that IMMC's compliance with the POC would suffice to constitute substantial compliance with the covered program requirements. Certainly, the express instruction sent to IMMC by IDPH did not so state. Instead, IMMC was informed that if it submitted both an acceptable POC and a credible allegation of compliance, IDPH would "presume that the facility is in compliance on the above date, unless, during the revisit, the Department determines otherwise." HCFA Ex. 2, at 2. This language indicates that, while it was hoped that the POC would provide sufficient improvement to result in substantial compliance, that outcome was not a foregone conclusion. Nothing in the letter suggests that IDPH could determine that compliance had not actually been achieved only if new deficiencies had arisen not found during the original survey.

Nor would such a restriction on the survey agency be a logical or necessary consequence of the requirement that the POC be accepted by the survey agency. For example, many of the POC provisions in IMMC's plan included a commitment to provide additional in-service training to address deficient staff performance. See, e.g., HCFA Ex. 1, at 12, 19, 20. Such training may often suffice to improve staff performance. However, approval of in-service training as a response to deficiencies in performance cannot mean that a facility is insulated from responsibility if the staff is found on a revisit to be continuing to perform deficiently despite the training. Otherwise, the effect would be to replace federal participation requirements with the terms of a POC. IMMC pointed to no authority by which a state survey agency is authorized, by its acceptance of POCs, to grant facilities permission to operate in violation of federal participation requirements.

As the ALJ pointed out, HCFA addressed the effect of compliance with a POC in the preamble to regulations adopting the present enforcement scheme. HCFA there rejected a suggestion that a CMP should be increased whenever a facility failed to follow its POC and stated that:

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). The same reasoning underlies the ALJ's conclusion in this case that surveyors on the revisit properly looked at actual compliance, not simply at completion of the POC.

We therefore sustain the challenged FFCL.⁽⁴⁾

3. Substantial evidence on the record as a whole supported the ALJ's finding with regard to Ethel K.

The second FFCL to which IMMC took exception read as follows:

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.

ALJ Decision at 13. IMMC argued that the ALJ erred in rejecting the testimony presented by IMMC that it had complied with its POC in its treatment of Ethel K., even where, according to IMMC, that testimony was uncontradicted. IMMC Br. at 4-6, 10-12. Further, IMMC argued that the ALJ erred in treating as irrelevant opinions of a nurse and doctor offered by IMMC that Ethel K.'s health did not deteriorate during her stay. Id. at 6-7, 12-13. IMMC also contended that there was no evidence that any error in recording Ethel K.'s weight presented a potential for more than minimal harm, as the ALJ found. Id. at 12-13.

Among the uncontested findings from the initial survey were that no weight was recorded for Ethel K. on her original admission (in March 1997) and that she was not provided with adequate nutrition or services as ordered by her physician for her tube feeding after coronary bypass surgery. ALJ Decision at 14; HCFA Ex. 1, at 11.

During the revisit in May 1997, the surveyors reported that weights recorded for this resident varied widely (from 106 to 152 between mid-March and May) and that the nutritional notes indicated that, after the accuracy of the weights was questioned, facility staff responded by making a correction by subtracting 51 pounds because that reflected the weight of her wheelchair which they concluded had been erroneously included in her weight. See HCFA Ex. 2, at 1-3; HCFA Ex. 23, at 2. The surveyors had her weighed without the wheelchair and found that her weight was 127.1 on May 28, 1997. HCFA Ex. 2, at 3. The ALJ found that IMMC had acknowledged that no weight was placed on the admissions records for Ethel K. when they were completed originally, but that a weight of 105.8 was inserted there at a later date. See ALJ Decision at 14, n.14 and record citations therein.

A surveyor who was also a registered dietician testified that the unreliability of the weight records could significantly impact planning for adequate nutritional and fluid intake for this very compromised resident and could potentially cause her harm. Tr. at 58-62. HCFA also presented expert testimony from a registered nurse with a master's degree in public health who reviewed the records and concluded that the extreme weight fluctuations should have triggered concern and that using incorrect weight figures for a resident in her very serious medical condition was potentially dangerous. Tr. at 123-26. Based on this testimony, the ALJ concluded that the Ethel K. was placed at risk of more than minimal harm by the failure to accurately assess her weight. ALJ Decision at 15-16

Ms. Kraker-Urso, vice-president and administrator of IMMC and a registered nurse, admitted that the weights recorded for Ethel K. were wrong and that they were altered without reweighing her. Tr. at 154-55. She stated that this was done because the aide who weighed Ethel K. reported that she failed to deduct the weight of the wheelchair. Tr. at 155. Ms. Kraker-Urso testified that this conclusion was consistent with the May weight for Ethel K. which was 101. Tr. at 154. She also testified that Ethel K. had a history of dramatic weight fluctuations within brief time frames, which she attributed to edema. Tr. at 153-55. IMMC argued that the discovery and correction of the erroneous weight records by IMMC reflected its performance of POC provisions, in that the problem was identified and action taken to correct the records. Also, IMMC argued that the addition of an admission weight for March that was not on Ethel K.'s records at the time of the April survey was simply the result of carrying out the POC requirement that all records would be audited for an admitting height and weight and corrected if missing.

A careful review of the record as a whole demonstrates that the ALJ's findings as to Ethel K. are supported by substantial evidence. The ALJ found the testimony and arguments presented by IMMC neither credible nor internally consistent. ALJ Decision at 18. As the ALJ pointed out, there was no actual weight recorded at 101, but only an after-the-fact addition to the admission records showing a weight near that figure, on which IMMC relied in a circular fashion to validate the idea that the questioned weight of 152 resulted simply from adding the 51-pound weight of the wheelchair. ALJ Decision at 18-19. There was no evidence of any actual accurate weight taken of Ethel K. between admission and the weight taken in front of the surveyors. No record evidence explains the selection of that particular weight to insert retroactively as her admitting weight (nor was there any indication on the face of the records that the weight was not taken on admission but rather was added at a later date to the completed record). See ALJ Decision at 18-19; see also HCFA Exs. 23, at 4 and 31, at 9; Tr. at 193. Furthermore, Ms. Kraker-Urso's testimony that Ethel K.'s weight had ranged as high as 179.9 during the period before the revisit, increased from 127 to 156 within a very short time after the revisit, and thus was extremely variable undercuts, rather than supports, the conclusion that earlier weight measurements of Ethel K. could reliably be altered by subtracting the wheelchair weight. The ALJ also noted that the aide who allegedly made the assertion about this error was never identified or made available for cross-examination by HCFA. ALJ Decision at 20.

IMMC complained that the ALJ had simply rejected the testimony of Ms. Kraker-Urso out of hand because she "had an interest in the outcome of the investigation . . . ." ALJ Decision at 20; IMMC Br. at 5. However, it is clear that the ALJ did not dismiss the testimony but rather analyzed it carefully and found that it did not support IMMC's arguments. Furthermore, it was entirely proper for the ALJ to assess the credibility of the witnesses appearing before her. The facts to which the ALJ alluded, e.g., that Ms. Kraker-Urso was the one who formulated the plan of correction and who interviewed the aide, as well as having a management position at IMMC, were reasonable factors for the ALJ to consider in deciding how much credence to give to opinions expressed by the witness.

IMMC argued further that the ALJ should not have dismissed Ms. Kraker-Urso's uncontradicted testimony that weight alone is not the only information on which a nutritional assessment is based. IMMC Br. at 6. However, the ALJ's conclusion was not that this testimony was not credible but that it failed to address the clear evidence of record that accurate weight measurements are important to nutritional assessments, especially with the medical problems that Ethel K. suffered. ALJ Decision at 21, n.22.

IMMC also argued that the ALJ had substituted her own opinion for the medical testimony of witnesses in rejecting the assertions of Ms. Kraker-Urso (a nurse) and of Ethel K.'s physician (in the form of a letter) to the effect that Ethel K.'s health improved rather than deteriorated during her stay at IMMC. IMMC Br. at 6-7. Again, the ALJ did not reject the evidence on this point as lacking credibility but rather as lacking relevance. ALJ Decision at 22-23. The ALJ held that noncompliance in this context did "not turn on whether Ethel K. had manifested outward signs of deterioration" but rather on whether the facility subjected her to a potential for more than minimal harm, even if that potential was, happily, not translated into actual injury in this case. Id. This reasoning is in accord with our prior holdings that a deficiency finding that caused no actual harm but presented a potential for more than minimal harm would justify a finding that the facility was out of substantial compliance. See, e.g., Lake City Extended Care Center, DAB No. 1658, at 24-26 (1998); CarePlex of Silver Spring, DAB No. 1627, at 24 (1997). Any other result would make meaningless the regulatory definition of substantial compliance as a level of compliance "such that any identified deficiencies pose no greater risk to resident health or safety than the potential for causing minimal harm." 42 C.F.R. � 488.301; see also 59 Fed. Reg. at 56,153 (Nov. 10, 1994).

We find that substantial evidence on the record as a whole supported the ALJ's finding with regard to Ethel K. and that no legal error has been shown. We therefore affirm FFCL 4 as quoted above.

4. Substantial evidence on the record as a whole supported the ALJ's finding with regard to Jan H.

The third FFCL to which IMMC took exception read as follows:

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.

ALJ Decision at 23. On their revisit, the surveyors had found that Jan H. was eating alone in his room despite a warning sign that he needed assistance and despite a pharyngeal study dated nine days earlier showing swallowing problems. HCFA Ex. 1, at 3, and Ex. 3, at 4; Tr. at 70-73. IMMC argued that the care given to Jan H. was compliant because the facility's procedure required only that, at the time the meal was brought to him, he be given verbal reminders to eat slowly and use chin tucks to avoid choking. IMMC Br. at 11. IMMC also argued that no potential for more than minimal harm was demonstrated in Jan H.'s case because he was sufficiently alert and understood the precautions himself and, in fact, was released to return to work soon after the revisit. Id. at 13-14. Finally, IMMC argued that the participation requirements did not apply to Jan H. because he was not a Medicare or Medicaid resident. Id. at 14.

Because the uncontested deficiencies from the first survey included improper handling of residents with swallowing problems, the POC stated that IMMC would provide in-service training to its staff on proper monitoring of such patients, 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," and that "[s]wallowing precautions will be posted above the bed" and the "nursing supervisor will check this daily." HCFA Ex. 1, at 1-3.

It was uncontested that Jan H. had been assessed as having difficulty swallowing and as aspirating thin fluids and that a sign was posted above his bed indicating that he needed to eat slowly and use chin tucks to swallow. On the survey date, Jan H. was observed eating alone in his room and hurrying because a driver was waiting to take him to an outside appointment. HCFA Ex. 3, at 4; Tr. at 69. The nurse assigned to his care indicated to the surveyor that she did not know Jan H. needed assistance in eating. Tr. at 71-72.

IMMC offered no evidence in support of its claim that "facility policy" was to require only verbal cuing on meal delivery. This claim conflicts with the assertions in the POC as to how patients with swallowing problems would be handled. Ms. Kraker-Urso testified that Jan H. had entered the facility on tube-feeding but that he had been upgraded to a general diet, that he himself chose to eat in his room, and that he was able to understand the instructions and managed well enough to be released soon after. See IMMC Br. at 11-12; Tr. at 157, 163, and 168-70. However, as the ALJ noted, even if the contentions presented by IMMC were all true, they would not suffice to rebut the evidence that IMMC failed to comply with participation requirements in its treatment of Jan H.

The only evidence offered that Jan H. was eating in his room by choice was the conclusory testimony of Ms. Kraker-Urso that he had a right to do so. ALJ Decision at 29. There was no evidence that she had any personal knowledge of his refusing to eat in the lounge and no record was introduced documenting such a refusal, even though regulations require such records of refusal of an offer of service. Id.; 42 C.F.R. � 483.20(d)(1)(ii).

The ALJ reasonably gave reduced weight to Ms. Kraker-Urso's testimony about the contents of revisions to Jan H.'s care plan and orders from his physician, in light of the fact that IMMC expressly declined to offer the documents into evidence. ALJ Decision at 29-30. Also, the ALJ noted that the testimony was internally inconsistent. ALJ Decision at 30-31. For example, Ms. Kraker-Urso's own testimony was that Jan H. was upgraded to a general diet in the beginning of June 1997, but did not explain why then he was receiving a general diet on May 28, 1997 at the survey visit. Id.

Clearly, IMMC did not implement its own POC in that a patient with posted swallowing precautions was permitted to eat alone in his room without one-on-one supervision. However, the ALJ did not rest the conclusion that the care given to Jan H. was deficient on the failure to fully apply the terms of the POC per se. ALJ Decision at 31-32. The ALJ found, for example, that IMMC offered no credible evidence even that IMMC applied its purported policy of providing verbal cues on meal delivery, since it did not identify a staff member who delivered the meal or gave any such cue to Jan H. Id. at 32-33. In addition, the ALJ noted that IMMC offered no evidence that Jan H. received any assistance during the meal in question or that he had previously received supervision and assistance in accordance with the swallowing assessment. Id.

As discussed in regard to Ethel K., IMMC is mistaken in its argument that no deficiency can be found in the case of Jan H. because his condition improved rather than deteriorating. Cf. IMMC Br. at 12. The ALJ correctly concluded that residents are protected from exposure to conditions that present a potential for more than minimal harm, not only from conditions that actually injure them. ALJ Decision at 34-35. The ALJ credited testimony by HCFA's witnesses that the risk presented to Jan H. was that he might have choked while eating alone and hurriedly. ALJ Decision at 25; Tr. at 74-76, 129.

Finally, IMMC argued that participation requirements expressly permit a facility to include in its provider agreement a "distinct part," less than the entire institution, which participates in Medicare and Medicaid, in which case other parts need not comply with the requirements. IMMC Br. at 14-16; 42 C.F.R. � 483.5. This legal argument is inapposite in light of the evidence cited by the ALJ and not challenged by IMMC on appeal that Jan H. was in a bed specifically certified for Medicare. ALJ Decision at 27-28.

IMMC nevertheless suggested that applying the participation requirements to its care of Jan H. would somehow contravene contract law. IMMC Reply Br. at 7. IMMC defined the applicable contract as the provider agreement by which "HCFA offered to pay the Facility for the services provided to a Medicare resident, the Facility accepted the offer, and, in consideration for the promise to pay for those services, the facility agreed to abide by the participation requirements." Id. We have previously observed that the provider agreement is not a straightforward bilateral contract, but rather is governed by statutory and public policy considerations, and that among those considerations is the independent obligation to comply with all conditions of participation to qualify to receive payments. See Hillman at 16-17, and n.12.

Furthermore, IMMC acknowledged that it agreed to abide by the participation requirements in the portion of the facility certified to provide care to Medicare residents in order to continue to qualify to receive payments for care provided to its Medicare residents. IMMC pointed to nothing in its assurances that would permit it to selectively comply with those requirements in the certified part of its facility based on the source of payments for care to an individual resident.

We find that substantial evidence on the record as a whole supported the ALJ's finding with regard to Jan H. and that no legal error has been shown. We therefore affirm FFCL 5 as quoted above.

1. Both parties were apparently unaware that DAB No. 1611 had been upheld by the District Court on appeal. Hillman Rehabilitation Center v. U.S. Dep't of Health and Human Services, No. 98-3789 (D.N.J. May 13, 1999).

2. Neither party excepted to any FFCL other than the three discussed in the analysis and therefore the remaining FFCLs are affirmed without further discussion.

3. IMMC argued that, while "mere acceptance by HCFA, or 'completion,'" of a POC does not prove substantial compliance, IMMC was "in compliance with its plan of correction on the date of the revisit survey and, because no other deficiency was cited" besides those addressed in the POC, it must therefore be found in substantial compliance. Id. (emphasis in original). The decision in Cross Creek clearly stated that even when a POC is accepted, a facility "is not regarded as in substantial compliance until HCFA determines, usually through a revisit survey, that the deficiency no longer exists." Cross Creek at 3 (emphasis added). Thus, substantial compliance depends on a factual assessment that the pre-existing deficiency has been eliminated, not merely on determining that the POC has been complied with and no new deficiencies discovered.

4. In this section we resolved only the legal issue raised concerning this FFCL. We do not thereby imply that IMMC did in fact comply fully with its POC. The factual disputes are discussed later in this decision.