Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Appellate Division

DATE: April 29, 1998

In the Case of:

Lake City Extended Care Center,
Petitioner,

- v. -

Health Care Financing Administration.

Civil Remedies CR494
App. Div. Docket No. A-98-13
Decision No. 1658

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

The Health Care Financing Administration (HCFA) appealed a September 23, 1997 decision by Administrative Law Judge (ALJ) Steven T. Kessel. Lake City Extended Care Center, DAB CR494 (1997) (ALJ Decision). Lake City Extended Care Center (Lake City, Petitioner) had sought a hearing before the ALJ challenging HCFA's imposition, pursuant to sections 1819 and 1919 of the Social Security Act, of a civil money penalty for failure by Lake City to comply substantially with requirements for participation in Medicare and Medicaid. HCFA found that Lake City's failure to comply substantially with 42 C.F.R. . 483.25--which requires that a long-term care facility provide to each of its residents "the necessary care and services to attain or maintain the highest practicable physical, mental, or psychosocial well-being, in accordance with the comprehensive assessment and plan of care"--was widespread and posed immediate jeopardy to Lake City's residents. HCFA also found that Lake City's failure to comply substantially with the participation requirement at section 483.40(a)(1) and (2) was widespread and caused actual harm and that its failure to comply substantially with the participation requirements at section 483.20(b) and section 483.20(d) was widespread and posed a potential for more than minimal harm. See HCFA Ex. 5, at 2, 5, 7, 12. Based on these findings, HCFA imposed a $7,500 per day civil money penalty beginning November 21, 1995 (the date of completion of the survey in which these findings were made) until December 19, 1995 (the date of the resurvey which found Lake City in compliance). The ALJ concluded that, contrary to what HCFA had found, Lake City complied substantially with section 483.25 and that HCFA therefore had no authority to impose the $7,500 per day civil money penalty. The ALJ further concluded that he had no authority to impose a civil money penalty in a lower dollar range based on the one incident he found violated the standard of care in section 483.25 or other deficiencies found by HCFA. Consequently, the ALJ stated that he would not decide whether the other deficiencies existed.

On appeal, HCFA objected to the ALJ's finding that Lake City complied substantially with section 483.25. Specifically, HCFA contended that the ALJ erred in finding that this section did not require Lake City to report to the treating physician any fevers above 101 degrees. HCFA also disputed certain findings of fact based on which the ALJ concluded that, except in one instance, Lake City did not violate a different standard of care which he found was applicable. In addition, HCFA contended that the ALJ erred in concluding that Lake City was in substantial compliance with section 483.25 notwithstanding his finding that Lake City violated the applicable standard of care in one instance where Lake City failed to report to the treating physician a patient's fever of 105.1 degrees. HCFA further contended that the ALJ erred in determining that he had no authority to impose a civil money penalty in the lower range.

Our standard for review of an ALJ decision on a disputed issue of law is whether the ALJ decision is erroneous. Our standard for 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. As discussed below, we find that there is substantial evidence in support of the ALJ's factual findings regarding both the applicable standard of care and the violations of the standard of care alleged by HCFA. We further find, however, that the ALJ erred in finding that Lake City was in substantial compliance with section 483.25 notwithstanding his finding that Lake City violated the applicable standard of care in one instance. In addition, we find that the ALJ erred in finding that he had no authority to impose a civil money penalty in the lower range.

We moreover proceed to address several questions that the ALJ did not reach in light of the findings in his decision. We find that the deficiency under section 483.25 based on Lake City's violation of the standard of care in one instance did not pose immediate jeopardy. Accordingly, there is no basis for imposing a civil money penalty in the upper range. However, we find that a civil money penalty in the lower range, in the amount of $500 per day, should be imposed based on the deficiency under section 483.25 as well as the deficiencies under the other participation requirements cited by HCFA, which we find existed. Finally, we reject Lake City's collateral arguments, raised before the ALJ but not resolved, that the surveyors' deficiency findings were invalid.

Procedural Background

HCFA's finding that Lake City failed to comply substantially with the federal requirements for participation in Medicare and Medicaid was based on a survey of Lake City conducted on behalf of HCFA by the Florida Agency for Health Care Administration (State survey agency) on November 20 and 21, 1995. The survey was intended to determine whether Lake City had corrected the deficiencies found by the State survey agency during a survey conducted in September 1995. The November survey consisted of an on-site visit to the facility during which the surveyors reviewed a sample of Lake City's patient records and interviewed members of Lake City's staff. The report of the November 1995 survey identified four deficiencies in Lake City's operation, described above. These deficiencies are listed in the survey report under headings that are designated as "tags," each of which corresponds to a requirement of participation in the regulations. (Tag 309 corresponds to the surveyors' finding of a deficiency under section 483.25. The other deficiencies are listed as Tags 385, 272 and 279.) Under each tag are the facts found by the surveyors and an explanation of those findings. Also included under each tag are the surveyors' findings of the scope and severity of each deficiency. By letter dated November 30, 1995, the State survey agency advised Lake City that, since the surveyors found that conditions in the facility "had deteriorated to the point that immediate jeopardy to residents now exists," Lake City "will now be subject" to a civil money penalty of $7,500 per day (as well as a moratorium on admissions). HCFA Ex. 7, at 2.

By letter dated December 5, 1995, HCFA directed Lake City to file a plan of correction to address the deficiencies that were identified at the November 1995 survey. HCFA stated that it would terminate Lake City's participation in Medicare on December 27, 1995 if the immediate jeopardy to resident health and safety were not removed by that date. HCFA also advised Lake City that it might impose a civil money penalty against Lake City in the amount of $7,500 for each day that Lake City was not in substantial compliance with federal participation requirements.

Lake City filed a plan of correction with the State survey agency on December 12, 1995. The plan stated that Lake City would, no later than December 14, 1995, correct the deficiencies identified in the November 1995 survey (although Lake City did not concede that they existed). On December 18 and 19, 1995, the State survey agency conducted another survey and concluded that Lake City was complying substantially with all federal participation requirements. Based on this survey, HCFA determined that Lake City attained substantial compliance with federal participation requirements on December 19, 1995.

On February 22, 1996, HCFA notified Lake City that HCFA had determined to impose a civil money penalty of $7,500 per day against Lake City, commencing on November 21, 1995 and continuing until December 19, 1995. When the matter was not resolved through an informal dispute resolution procedure, Lake City requested a hearing before an ALJ.

HCFA filed a timely appeal of the ALJ Decision pursuant to 42 C.F.R. Part 498, Subpart E.

HCFA's Exceptions

HCFA excepted to the following findings of fact and conclusions of law (FFCLs) in the ALJ Decision:

2. The implied requirement in 42 C.F.R. . 483.25 that a facility monitor and, when medically indicated, report a resident's fever to the resident's treating physician, does not . . . require a facility to report a resident's fever to the resident's physician whenever the fever exceeds 101 degrees Fahrenheit.

2.b. The temperature reporting requirement that is incorporated in 42 C.F.R. . 483.25 is the professionally recognized standard of care that a nursing home's professional staff report to a resident's treating physician any change in the resident's temperature that indicates a medically significant deterioration in the resident's condition.

3. The method by which Petitioner measured residents' temperatures is not relevant to my decision.

4. Petitioner followed professionally recognized standards of care in providing care to Resident 5.

5. Petitioner followed professionally recognized standards of care in providing care to Resident 1.

6. Petitioner complied substantially with the requirements of 42 C.F.R. . 483.25 between November 21, 1995 and December 19, 1995.

7. There is no basis for me to sustain a civil money penalty against Petitioner in the upper range of civil money penalties for the period beginning November 21, 1995 and ending on December 19, 1995 premised on Petitioner's alleged failure to comply substantially with the requirements of 42 C.F.R. . 483.25.

8. There is no basis for me to sustain a civil money penalty against Petitioner in the lower range of civil money penalties for the period beginning November 21, 1995 and ending on December 19, 1995 premised on Petitioner's alleged failure to comply substantially with the requirements of 42 C.F.R. . 483.25.

9. I am without authority to impose a civil money penalty against Petitioner based on the allegations made at tags 272, 279, and 385 in the report of the November 1995 survey of Petitioner.

HCFA did not appeal FFCLs 1, 2a, and 7. Accordingly, we sustain those three FFCLs without further discussion. We address the remaining FFCLs in the discussion that follows and list our new FFCLs at the conclusion of this decision.

Discussion

1. There is substantial evidence supporting the ALJ's determination as to the applicable standard of care for reporting a resident's fever.

HCFA did not dispute that, as the ALJ found, "[t]he broad requirements of 42 C.F.R. . 483.25 implicitly include a requirement that a facility adhere to professionally recognized standards of care in providing care and treatment to its residents." ALJ Decision at 16. HCFA also did not dispute that "the professionally recognized standards of care which apply to a long-term care facility include standards which govern the medically appropriate monitoring and reporting of residents' fevers." Id. However, HCFA disputed the ALJ's conclusion as to the applicable standard for reporting a resident's fever, reflected in FFCLs 2 and 2a. The ALJ concluded that "[t]here is no specific temperature which triggers a reporting requirement." ALJ Decision at 20.

Instead, the ALJ ruled:

The temperature reporting requirement that is incorporated in 42 C.F.R. . 483.25 is the professionally recognized standard of care that a nursing home's professional staff report to a resident's treating physician any change in the resident's temperature that indicates a medically significant deterioration in the resident's condition.

ALJ Decision at 17. The ALJ subsequently reiterated this standard, adding that "[w]hat is significant depends on the unique circumstances which pertain to each individual resident." ALJ Decision at 21. On appeal, HCFA maintained, as it did before the ALJ, that this was not the applicable standard of care and that a facility must report a resident's fever to the treating physician whenever the fever exceeds 101 degrees. If this were the applicable standard, Lake City would have violated the standard of care in several instances in the case of one patient and in one instance in the case of another patient, as HCFA found. Thus, we must determine here whether there is substantial evidence supporting the ALJ's finding as to the applicable standard of care.

At the hearing conducted by the ALJ, two witnesses testified concerning the applicable standard of care, HCFA's witness Mr. Fuller and Lake City's witness Dr. Page. The ALJ found that Dr. Page's explanation of the standard of care was more persuasive than the explanation given by Mr. Fuller. The ALJ stated that Dr. Page's qualifications as an expert were stronger than those of Mr. Fuller since "Dr. Page is a physician who specializes in geriatric care and the medical director of two nursing homes." ALJ Decision at 21. The ALJ also stated that "Dr. Page gave a coherent explanation of the circumstances under which a nursing home should report a resident's elevated temperature," while "Mr. Fuller merely recited the asserted requirement that every temperature in excess of 101 degrees must always be reported, without explaining why . . . ." ALJ Decision at 21-22.

On appeal, HCFA argued that Dr. Page's testimony was "of little relevance" because he testified as to what standard of care should be followed by a physician in determining whether a change in treatment was justified when the salient question is what standard of care should be followed by nursing home staff in determining when to report a patient's condition to the treating physician. HCFA Br. at 26-27. We find no merit in this argument. Dr. Page expressly addressed the question of when nursing home staff should report to the physician. See e.g., Tr. at 329-330, 337, 351-352. The fact that he also testified that he would not have changed the treatment of the patients in question had he been called whenever their fevers exceeded 101 degrees does not detract from his testimony regarding the standard of care for reporting to the physician.

HCFA also argued in effect that Dr. Page was not a credible witness both because he was paid to testify and because he was allegedly not familiar with the medical records of the patients in question. The ALJ specifically addressed the first point, finding that "HCFA did nothing to impeach Dr. Page's credibility, aside from suggesting that his testimony was motivated by the compensation he received for it." ALJ Decision at 26. With respect to the second point, even if it were true that Dr. Page was not familiar with the medical records, that would not have any bearing on his opinion as to the standard of care in long-term care facilities for reporting fevers to the treating physician. Such an opinion does not hinge on a knowledge of individual medical records. In any event, Dr. Page's testimony was clearly based on the medical records in question where they were germane.

HCFA also disputed the ALJ's statement that Mr. Fuller did not explain why the standard of care should be to report fevers over 101 to the treating physician. HCFA noted Mr. Fuller's testimony that, as a nurse, he would call the treating physician where a patient's fever exceeded 101 degrees because he would expect the physician to issue orders to prevent the fever from getting worse and because the nature of these orders would depend on the severity of the fever. See HCFA Br. at 28, citing Tr. at 76-77. HCFA argued that this constituted a compelling rationale for finding that this was the applicable standard of care: i.e., that "facility staff lack the expertise, and the legal authority, to make medical assessments and give treatment orders for fevers over 101." Id. at 28; see also id. at 29 and HCFA's post-hearing brief at 33-34. The ALJ did not specifically address this argument in his decision. However, HCFA did not point to any evidence in the record to support the argument that facility staff lacked legal authority to assess a patient's condition. Moreover, section 483.40(c) requires that a resident be seen by a physician once every thirty days for the first ninety days after admission, and then at least once every sixty days thereafter. See section 483.40(c). This requirement assumes that facility staff are capable of assessing a patient's condition between physician visits and determining if physician notification is warranted. HCFA did not argue that any nurse aides or licensed practical nurses who provided care at Lake City were not properly supervised by registered nurses. Furthermore, while HCFA is correct that only a physician is authorized to give treatment orders, HCFA's argument ignores the fact that there are often, as the ALJ found was the case here, pre-existing orders for treatment which remain adequate even when a patient's fever rises above 101 degrees. Thus, the need for physician's orders does not justify a standard of care which requires that each incident of a fever over 101 degrees must routinely be reported to the treating physician.

The ALJ also relied on the fact that the plan of correction submitted by Lake City in response to the November 1995 survey did not represent that Lake City would report every fever which exceeded 101 degrees. Instead, the plan of correction proposed to implement an acute care charting system which gives explicit instructions to nurses concerning the care to be provided to residents who suffer from acute illnesses. The ALJ found that this proposal "is consistent with the kind of monitoring and reporting that Dr. Page testified would be appropriate." ALJ Decision at 23. The ALJ further stated that "[t]he fact that HCFA accepted a plan of correction which did not bind [Lake City] to report every resident temperature in excess of 101 degrees at least suggests that HCFA did not consider the asserted reporting standard to be a mandatory requirement that long-term care facilities follow." Id.

On appeal, HCFA argued that the inference made by the ALJ from HCFA's acceptance of the plan of correction was erroneous. HCFA argued specifically that a plan of correction "need not mirror the deficiency statement, because [the] function [of the plan of correction] is to demonstrate how a facility will address the underlying causes of deficiencies." HCFA Br. at 29. It is unclear what HCFA meant by this argument. Certainly, it does not explain why the ALJ could not reasonably infer, from the fact that HCFA accepted a plan of correction which adopted a different standard of care, that there was no mandatory standard of care requiring that all fevers in excess of 101 degrees be reported regardless of the circumstances and any existing orders.
HCFA also argued that the ALJ erred in finding that a protocol that Lake City had in place during the November survey, stating "[f]or fever greater than 101 call physician," was not persuasive evidence of the applicable standard of care. See HCFA Ex. 6, at 25, "OTC Protocol" signed by the treating physician and a licensed nurse on 11/2/95.) We disagree. The ALJ noted that HCFA itself conceded that "failure by a facility to comply with a protocol is not a failure to comply with a participation requirement where the protocol does not comport with a professionally recognized standard of care and where the participation requirement does not direct a facility to follow each of its internal protocols." ALJ Decision at 22. Moreover, on appeal, HCFA identified the issue as whether Petitioner had proven "by a preponderance of the evidence that there is no recognized princip[le] of nursing home operations that requires notifying physicians of temperatures ranging from 101 to 105.1." HCFA Br. at 23 (emphasis added). Thus, HCFA itself took the position that a facility's protocol may not necessarily reflect the standard of care to which long-term care facilities are generally held. Furthermore, the fact, noted by HCFA, that Lake City's director of nursing told surveyors that "the physician is always called when the resident has a fever in excess of 101 degrees" merely confirms that this was Lake City's policy and is not tantamount to an admission that this is the applicable standard of care. See HCFA Br. at 24, and HCFA Ex. 5, at 11. Accordingly, we find that there is substantial evidence in the record as a whole that supports the ALJ's finding as to the applicable standard of care for reporting a patient's fever to the treating physician. Thus, reversal of the ALJ Decision is not warranted on this basis. We therefore sustain FFCLs 2 and 2b.

2. The ALJ did not err in concluding that the differences between methods of measuring temperature were irrelevant to the issues presented.

At the hearing, HCFA's witness Mr. Fuller testified regarding the three methods of measuring body temperature (oral, rectal and axillary) and the difference between the temperature readings obtained by each method of measurement. Tr. at 58-59. Subsequent to the hearing, Lake City provided an excerpt from a medical treatise which indicated that the difference between the temperature readings was smaller than HCFA's witness had stated. P. Ex. 16. The ALJ found this dispute "largely to be irrelevant to [the] decision." ALJ Decision at 24. Specifically, the ALJ stated that, in view of his finding that there is no standard of care that requires a facility automatically to report a temperature of more than 101 degrees to the treating physician, "the fact that a resident's temperature might be above 101 degrees, depending on the method by which that temperature is taken, is not significant to my decision." Id. The ALJ continued:

What is significant is whether a resident manifests a temperature change that establishes a significant deterioration in the resident's condition. No party disputes that such a change may be recorded by any of the accepted ways of taking an individual's temperature. Id.

On appeal, HCFA excepted to FFCL 3, which found that the method of temperature measurement was not relevant to the decision. HCFA argued that "evidence regarding the accuracy and significance of various measurements" was relevant even under the standard of care the ALJ found was applicable, since "there is some point at which staff should consult physicians." HCFA Br. at 30. HCFA also asserted that this evidence was "directly relevant to the surveyors' finding [under section 483.40(a)(1) and (2)] that the facility's protocol to guide staff was deficient because it failed to specify whether it meant oral, rectal or axillary temperature." Id.

We conclude that the ALJ did not err in finding that the method of temperature measurement was irrelevant to the issues presented. HCFA's assertion that "there is some point [i.e., some specific temperature] at which staff should consult physicians" ignores the ALJ's point that what is important is whether there is a temperature change that signals a significant deterioration in the patient's condition. Thus, it is not the magnitude of the temperature that is important, but whether the temperature change signals a deteriorating condition. HCFA did not argue that a temperature change could not be discerned if the patient's temperature were measured using one method as opposed to another method or even if different methods were used to measure a patient's temperature at different times.

HCFA's argument that the method of temperature measurement is relevant to the issue of whether the surveyors properly found that Lake City's protocol was deficient also lacks merit. This argument is predicated on the assumption that the protocol was binding on the facility. As discussed earlier, the ALJ found that the protocol did not reflect the applicable standard of care. Thus, unless the protocol was part of a care plan or was otherwise required under the regulations (which HCFA did not allege was the case), Lake City's failure to follow the protocol was not significant here.

Accordingly, we sustain FFCL 3.

3. There is substantial evidence supporting the ALJ's conclusion that Lake City complied with the standard of care in section 483.25 in caring for Patients 1 and 5 in all but one incident.

HCFA argued that, even applying the standard of care he found was proper, the ALJ erred in finding, in FFCLs 4 and 5, that Lake City complied with the standard of care in caring for Patients 1 and 5. According to HCFA, the ALJ made numerous errors of fact in determining that none of the incidents identified by the surveyors except one incident involving Patient 5 constituted violations under the standard he applied.

We have carefully reviewed the record with respect to all of the factual findings challenged by HCFA, including all of the evidence on which HCFA relied in support of its position. We conclude that there is substantial evidence in the record as a whole that supports the ALJ's findings. Thus, reversal of these findings is not warranted.

Accordingly, we sustain FFCL 5 without further discussion. Although we do not accept HCFA's arguments in opposition to either FFCL 4 or FFCL 5, we nevertheless modify FFCL 4 as follows to reflect the fact that the ALJ found that Lake City violated the standard of care in one incident involving Patient 5:

There was one incident in which Petitioner failed to follow professionally recognized standards of care in providing care to Resident 5.

4. The ALJ erred in finding that Lake City complied substantially with the requirements of section 483.25 during the period for which the civil money penalty was imposed.

The ALJ found that Lake City "contravened a standard of care" incorporated in section 483.25 with respect to Patient 5 when it failed to report her fever of 105.1 degrees to her treating physician on September 24, 1995 and that "[t]hat failure posed a risk of harm to the resident's health or safety that was more than minimal." ALJ Decision at 40. The ALJ found that Lake City therefore "did not comply substantially with the requirements" of that section on that date. Id. The ALJ further found, however, that Lake City "complied substantially with the requirements of" that section "on all other relevant dates." Id. The ALJ therefore determined that there was "no need" for him to consider whether HCFA established a prima facie case that Lake City's failure to comply with the regulation was of a level of severity that posed immediate jeopardy to Lake City's residents since "I may not sustain a civil money penalty against Petitioner in the upper range of penalties [which requires an immediate jeopardy finding]. . . unless I find that Petitioner failed to comply substantially with the requirements of 42 C.F.R . 483.25 during the period from November 21, 1995 until December 19, 1995." Id. at 42 (emphasis in original).

HCFA argued, and we agree, that the ALJ erred in determining, in FFCL 6, that Lake City complied substantially with the requirements of section 483.25 during the period for which the civil money penalty was imposed. As discussed below, this determination misconstrues the regulatory scheme for imposing civil money penalties.

Civil money penalties are one of a number of remedies that may be available when a facility is found not to comply substantially with the conditions of participation in Medicare at 42 C.F.R. Part 483. Skilled nursing facilities (SNFs), such as Lake City, are surveyed at least every 15 months to determine compliance with the conditions of participation. Sections 488.20(a) and 488.308(a). A SNF must be surveyed more often if necessary to ensure that identified deficiencies are corrected. Section 488.308(c). Based on the survey, the surveyors prepare a report that lists the deficiencies found, the regulations to which they relate, the surveyors' findings as to the scope and severity of the deficiencies and the specific findings that support each deficiency determination. The severity categories range from deficiencies that cause "no actual harm with a potential for minimal harm" to ones that pose "immediate jeopardy to resident health or safety." Section 488.404(b)(1). The scope can be "isolated," "pattern," or "widespread." Section 488.404(b)(2). An isolated deficiency occurs "when one or a very limited number of residents are affected . . . and/or the situation has occurred only occasionally . . . ." Tr. at 226-227 (reading into record from State Operations Manual, Transmittal Number 274, page P-49.B).

Where a deficiency is found to be isolated and involve no actual harm with a potential for minimal harm, the facility is deemed to be in substantial compliance, and no action may be taken against it. Sections 488.301 (definition of "Substantial compliance"), 488.402(d)(2) and 488.408(f)(2). However, where there is a deficiency of any other scope and severity, the facility must submit a plan of correction which describes "1. How corrective action will be accomplished 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; 3. What measures will be put into place or systemic changes made to ensure that the deficient practice will not recur; and 4. How the facility will monitor its corrective actions to ensure the deficient practice is being corrected and will not recur, i.e., what program will be put into place to monitor the continued effectiveness of the systemic changes." State Operations Manual, section 7304; see also sections 488.401 (definition of "Plan of correction"), 488.402(d) and 488.408(f)(1). Even if the plan of correction is accepted, the facility is not regarded as in substantial compliance until HCFA determines, usually through a revisit survey, that the deficiency no longer exists. Section 488.440(b) and (h).

For deficiencies of a certain scope and severity, HCFA may impose a civil money penalty, which may start accruing as early as the date that the facility was first out of compliance and continues until the date the facility achieves substantial compliance. Sections 488.408 and 488.440(a) and (b). A civil money penalty in the $3,050 to $10,000 range must be imposed where a deficiency poses immediate jeopardy, regardless of its scope. Section 488.408(e)(2)(iii) and (d)(3)(ii). Absent immediate jeopardy, a civil money penalty in the $50 to $3,000 range must be imposed where a widespread deficiency causes no actual harm with a potential for harm that is more than minimal or where a deficiency of any scope causes actual harm. Section 488.408(d)(2). A civil money penalty in the same range may be imposed based on any other deficiency except where the facility is in substantial compliance. Section 488.408(d)(3).

Under this regulatory scheme, once the surveyors found that Lake City had a deficiency involving a potential for more than minimal harm, Lake City could not be considered in substantial compliance until it submitted a plan of correction and HCFA determined that Lake City had come into substantial compliance. Lake City submitted a plan of correction dated December 12, 1995 (HCFA Ex. 5), and the facility was resurveyed and found in compliance on December 19, 1995. The ALJ's finding that Lake City was not in substantial compliance on September 24, 1995 but was in substantial compliance on all other relevant dates is thus erroneous as a matter of law.

In the ALJ's view, Lake City was out of substantial compliance only on September 24, 1995 because the incident on which he based his finding of substantial noncompliance was "only an isolated episode of [Lake City] not complying with professionally recognized standards of care in providing care to Resident 5," and there was not even "a prima facie case of a generalized failure by Petitioner to comply with standards of care. . . ." ALJ Decision at 40-41. The ALJ also stated that "the evidence of noncompliance by Petitioner on one date is greatly outweighed by evidence that Petitioner complied with professionally recognized standards of care in caring for Residents 5 and 1 in all of the other episodes cited" and "is outweighed also by evidence that there were no derelictions of care in the treatment that Petitioner gave to any of its other residents." Id. at 41. Furthermore, the ALJ found "affirmative evidence that Petitioner complied with the requirements of 42 C.F.R. . 483.25 after November 21, 1995." Id.

However, all of these approaches are contrary to the regulatory scheme, which assumes that any deficiency that has a potential for more than minimal harm is necessarily indicative of problems in the facility which need to be corrected. If this were not the assumption, there would be no basis for requiring a plan of correction in the case of such a deficiency. Moreover, a plan of correction is required regardless of the scope of the deficiency, as long as the deficiency has a potential for more than minimal harm or involves actual harm. Section 488.402(d)(2). Since the ALJ found that the incident in question had a potential for more than minimal harm, he was required to find that Lake City was out of substantial compliance from the date of completion of the survey in which this incident was cited until the date of the resurvey in which substantial compliance was established. (Substantial compliance here meant not only that surveyors found no other incidents like the one at issue after the November survey but also that Lake City had implemented a plan of correction designed to assure that no such incidents would occur in the future.) No findings that Lake City violated the standard of care between these dates were required in order to find Lake City out of substantial compliance, nor can evidence of other incidents in which Lake City met the standard of care change the fact that it was out of substantial compliance.

Lake City argued that a different standard was upheld by the Board in CSM Home Health Services, Inc.. The Board there stated that "the regulations require that, in order for termination to be justified, the manner and degree of the deficiencies must be considered," and concluded that the ALJ did not err when he found that termination was not justified where there was no evidence of a pattern of failure to comply with the regulations. DAB 1622, at 29. This statement is not inconsistent with our holding here. Properly evaluating the degree of the deficiency involves considering not only the number of incidents, but also the seriousness of the potential harm. In any event, that decision is inapposite since it involved the termination of a home health agency, not the imposition of a civil money penalty on a long-term care facility.

Lake City also argued that the ALJ's finding that it was in substantial compliance during the period for which the civil money penalty was assessed was consistent with section 488.26(c)(2). That section provides that, in determining compliance with participation requirements, the State survey agency must use "resident outcomes as the primary means to establish the compliance status of facilities." However, the preamble to the final regulations indicates that this requirement is reflected in the definition of "substantial compliance" as "a level of compliance with requirements of participation such that any identified deficiencies pose no greater risk to patient health and safety than the potential for causing minimal harm." 59 Fed. Reg. 56116, 56153. Similarly, while Lake City also noted that the preamble states that "[t]he substantial compliance standard . . . tolerates a reasonable degree of imperfection," the preamble identifies as "imperfection" the existence of "violations that constitute no actual harm and a potential for no more than minimal harm." Id. at 56226. The ALJ found that the incident that violated the standard of care in section 483.25, although it caused no actual harm, had a potential for more than minimal harm. ALJ Decision at 32-33. Thus, the outcome of this incident did not justify a finding of substantial compliance.

We therefore reverse FFCL 6 and substitute the following FFCL:

6. As a matter of law, Petitioner was out of substantial compliance with the requirements of 42 C.F.R. . 483.25 between November 21, 1995 and December 19, 1995.

5. It is necessary to reach the question whether the incident that the ALJ found violated the standard of care in section 483.25 posed immediate jeopardy.

Since the ALJ found, erroneously, that Lake City was in substantial compliance during the relevant period, the ALJ did not reach the question whether the incident that he found violated the standard of care in section 483.25 also posed immediate jeopardy. Sections 1819(h)(2)(A) and (B) and 1919(h)(3)(B) and (C) of the Act provide that the Secretary may impose a civil money penalty not to exceed $10,000 for each day of noncompliance where a deficiency poses immediate jeopardy. (As previously noted, the regulations provide for a civil money penalty in the $3,050 to $10,000 range where there is immediate jeopardy.) HCFA did not take the position that any of the other deficiencies found by the surveyors posed immediate jeopardy. Thus, in order to determine whether HCFA properly imposed a civil money penalty in the upper range, it must be determined whether the incident that the ALJ found violated the standard of care in section 483.25 posed immediate jeopardy.

6. The incident that the ALJ found violated the standard of care in section 483.25 did not pose immediate jeopardy.

In this section, we consider whether the incident that the ALJ found violated the standard of care in section 483.25 also posed immediate jeopardy. The applicable regulations define the term "immediate jeopardy" as--

a situation in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident.

42 C.F.R. . 488.301. Immediate jeopardy can exist regardless of the scope of the deficiency. See State Operations Manual, section 7500 (HCFA Ex. 15) (scope and severity grid showing isolated, pattern and widespread deficiencies constituting immediate jeopardy). Moreover, immediate jeopardy can exist regardless of the severity of the deficiency as long as the deficiency involves a potential for more than minimal harm. See section 488.408(d) and (d) (references to deficiencies "with a potential for more than minimal harm but not immediate jeopardy" and to deficiencies "that constitute actual harm that is not immediate jeopardy" imply that such deficiencies could pose immediate jeopardy). See also State Operations Manual, section 7500 (HCFA Ex. 15).

HCFA argued on appeal that a finding of immediate jeopardy was warranted because "HCFA adduced ample evidence that a fever of more than 101 that is undiagnosed and uncontrolled is likely to cause serious harm." HCFA Br. at 43. HCFA specifically relied on testimony by Lake City's witness Dr. Page that a sustained fever of 103 degrees poses risks of seizures and neurological damage. HCFA Br. at 46, citing Tr. at 359. HCFA maintained that the nursing notes showed that Patient 5 had a fever that high or higher for a period of nine hours, including the time when the patient's fever rose to 105.1 degrees. (HCFA did not contend that actual harm resulted in this case, however.)

We conclude that HCFA's argument that a finding of immediate jeopardy is warranted is clearly erroneous because HCFA incorrectly assumed that Patient 5 had an undiagnosed and uncontrolled fever and that the fever was at least 103 degrees for nine hours. As the ALJ Decision pointed out in concluding that there was no actual harm, the patient's fever was reduced as a result of the treatment that Petitioner provided for her elevated temperature. See ALJ Decision at 33. The nursing notes show that her fever, which was recorded at 105.1 degrees (rectal) at 9:40 p.m. on September 24, was 103 degrees (rectal) at 10:00 p.m., 102.4 at 10:30 p.m., 103 degrees at 10:45 p.m., and 103 degrees at 12:00 a.m. on September 25. Thus, the patient's fever was significantly reduced within 20 minutes of the time it was recorded at 105.1 degrees. Moreover, Lake City presented uncontroverted testimony that the treatment that would have been provided at a hospital would have been the same as that actually provided by Lake City's staff (administration of Tylenol and ice packs). See Tr. 259. Thus, even if the cause of the fever was undiagnosed, the fever was being controlled.

HCFA argued, however, that Patient 5 also had an undiagnosed and uncontrolled fever of over 101 degrees for a sustained period prior to the time the temperature of 105.1 degrees was recorded. HCFA pointed to the fact that this patient's temperature was not taken between 3:15 p.m., when her temperature was 102.5 degrees, and 9:40 p.m. on September 24, and noted that her temperature could have been as high as the 105.1 degrees recorded at 9:40 p.m. for the six and one half hours in between. We are unwilling to conclude based on mere speculation that the patient had an uncontrolled fever over 101 degrees for that period of time, however. Since HCFA did not dispute the ALJ's finding (at ALJ Decision at 20) that Lake City did not violate the standard of care for monitoring fever in the case of Patient 5, Lake City cannot be held responsible for what the patient's fever might have been during that period. For the same reason, the record does not clearly establish that, as HCFA asserted, Patient 5 had a sustained fever of at least 103 degrees for nine hours.

HCFA also pointed to testimony by one of Lake City's witnesses that "there could have been potential . . . harm to the resident" from the 105.1 degree temperature recorded on September 24 which the ALJ found should have been reported to the treating physician. See Tr. at 258 (emphasis added). However, it appears that the witness meant that there could have been a potential for harm if the patient's fever had not been controlled, as evidenced by her next statement that "[i]n fact, there was not, they continued to monitor and it came down . . . ." Id. In any event, HCFA's reliance on this testimony to establish that there was immediate jeopardy is unwarranted since, as noted above, there can be a potential for more than minimal harm without immediate jeopardy. The same witness later testified unequivocally that she did not believe that the failure to call the treating physician in this situation resulted in immediate or serious jeopardy to Patient 5. See Tr. 259. Furthermore, although HCFA relied on the testimony of Lake City's witness Dr. Page to show that there was immediate jeopardy, Dr. Page indicated that Patient 5 was not subject to the risks that might be posed by a fever above 103 degrees because "every time this patient was addressed with that, they documented that they treated it and brought it down." Tr. at 359.

HCFA also asserted that the incident in question here fit within two of the examples of immediate jeopardy listed in Appendix Q of the State Operations Manual. According to HCFA, one example that applied here was the situation where "staff do not know critical duties/procedures required for patients' care." HCFA Reply Br. at 18, quoting Appendix Q at Q-9 (P. Ex. 13). HCFA asserted that Lake City's staff "were either unaware of any protocol or procedure for physician notification, or they ignored it." Id. As discussed above, however, the record establishes only that there was one incident in which there was a failure to follow the procedures for reporting fevers to the treating physician required by the standard of care that the ALJ found was applicable. The record further shows that only one staff member was monitoring Patient 5 during this incident. See P. Ex. 7, at 20-21. In our view, this does not constitute a situation where facility staff do not know critical duties and procedures. The other example which HCFA said applied was failure by staff to respond to changes in physiologically monitored status. See State Operations Manual, Appendix Q at Q-10 (P. Ex. 13). However, as discussed above, the record clearly shows that Petitioner's staff did respond to Patient 5's elevation in temperature, providing appropriate care.
We therefore conclude that HCFA's position that the incident that the ALJ found involved a violation of the standard of care in section 483.25 posed immediate jeopardy was clearly erroneous. Accordingly, we reverse FFCL 8 and substitute the following FFCL:

There is no basis to sustain a civil money penalty against Petitioner in the upper range of civil money penalties for the period beginning November 21, 1995 and ending on December 19, 1995 premised on Petitioner's failure to comply substantially with the requirements of 42 C.F.R. . 483.25 since that deficiency did not pose immediate jeopardy.

7. Imposition of a civil money penalty in the lower range was warranted based on the deficiency under section 483.25.
As discussed above, there is no basis for the imposition of a civil money penalty in the upper range since the deficiency under section 483.25 did not pose immediate jeopardy. However, a lower range civil money penalty may be imposed under section 488.408(d)(3), which authorizes the imposition of a lower range civil money penalty based on any deficiency that has a potential for more than minimal harm that is not immediate jeopardy. See also State Operations Manual, section 7500 (HCFA Ex. 15). As discussed above, the ALJ correctly found that the deficiency under section 483.25 was isolated and had a potential for more than minimal harm. The ALJ in fact recognized that a lower range civil money penalty would be required under these circumstances, since he stated that he would have sustained a lower range civil money penalty against Lake City had he "concluded that Petitioner was not complying substantially with the requirements of 42 C.F.R. . 483.25, but that the level of noncompliance determined by HCFA (immediate jeopardy) was clearly erroneous." ALJ Decision at 43-44.
The imposition of a lower range civil money penalty is clearly within the Board's authority. Section 488.438(e), captioned "Review of the penalty," describes the limits on review of the civil money penalty "[w]hen an administrative law judge or State hearing officer (or higher administrative review authority) finds that the basis for imposing a civil money penalty exists . . . ." In explaining the intent of this provision, the preamble to the final regulations states:
. . . we are adding a paragraph to redesignated . 488.438 to explain the reviewability of the civil money penalty that is imposed on a SNF or NF for noncompliance with participation requirements. We now specify that in any case in which an administrative law judge or State hearing officer (or higher administrative review authority) finds that the basis for imposing a civil money penalty exists, as described in . 488.430, the administrative law judge or State hearing officer (or higher administrative review authority) may not: set a penalty of zero or reduce a penalty to zero; review the exercise of discretion by the Secretary or the State to impose a civil money penalty; or consider any factors in reviewing the amount of the penalty other than those specified at . 488.438(f). In other words, when the administrative law judge or State hearing officer (or higher administrative review authority) finds noncompliance supporting the imposition of the civil money penalty, he or she must remedy it with some amount of penalty consistent with the ranges of penalty amounts established in . 488.438.
59 Fed. Reg. 56116, 56206 (emphasis added). Accordingly, pursuant to the authority in this regulation, we are imposing a civil money in the lower range based on our finding that Lake City was out of substantial compliance with section 483.25 but that the deficiency did not pose immediate jeopardy (as well as on our findings of other deficiencies, discussed below).
Accordingly, we reverse FFCL 9 and substitute the following FFCL:
9. A civil money penalty should be imposed against Petitioner in the lower range of civil money penalties for the period beginning November 21, 1995 and ending on December 19, 1995 based in part on Petitioner's failure to comply substantially with the requirements of 42 C.F.R. . 483.25.
Before we can determine the amount of the civil money penalty in the lower range that should be imposed, however, we must determine whether the three other deficiencies found by the surveyors existed. The regulations provide that the factors affecting the amount of the civil money penalty include the scope and severity of the deficiencies. Sections 488.438(f)(3) and 488.404(b). Thus, although our determination that the deficiency under section 483.25 did not pose immediate jeopardy dictates that a lower range civil money penalty be imposed, the scope and severity of any other deficiencies that existed would affect the amount of the civil money penalty within that range. Furthermore, if these deficiencies existed, they would have been an independent basis for the imposition of a civil money penalty in the lower range absent any deficiency under section 483.25. The ALJ did not evaluate the evidence to determine whether any of these three deficiencies existed since he found that the civil money penalty imposed by HCFA was not based on these deficiencies. As discussed below, however, we conclude that this finding was erroneous.
8. HCFA's civil money penalty was imposed on the basis of all four deficiencies found in the November 1995 survey.
The ALJ found that the $7,500 per day civil money penalty was imposed solely on the basis of HCFA's finding that Lake City failed to comply with section 483.25 (although he noted that HCFA considered these deficiencies "as ancillary evidence" to support an upper range civil money penalty). The State Operations Manual, section 7400.E.1, provides that "[t]he remedy category to be applied against facility noncompliance will be determined by the most serious deficiency(ies) identified . . . ." ALJ Decision at 44. The record shows, however, that, while noncompliance with section 483.25 was the basis for HCFA's imposition of a civil money penalty in the upper range (since HCFA found that this deficiency posed immediate jeopardy), the civil money penalty was based on all of the deficiencies found by the surveyors. Specifically, HCFA's February 22, 1996 notice to Lake City stated in relevant part that "[t]his civil monetary penalty is based on the . . . facility's failure to comply with requirements for nursing home participation in the Medicare and Medicaid programs at 42 [C.F.R.] 483.1 et seq. as reflected in the Statement of Deficiencies." The Statement of Deficiencies identifies deficiencies under three conditions of participation in addition to section 483.25. See HCFA Ex. 5. As the Board has previously noted, there is no requirement that HCFA spell out in its notice letter all the findings on which it relies. See Desert Hospital, DAB 1623, at 10, n. 9 (1997). Moreover, the regulations clearly contemplate that a civil money penalty may be imposed based on multiple deficiencies, as was the case here. Section 488.402(c) provides that "HCFA . . . may apply one or more remedies for each deficiency constituting noncompliance or for all deficiencies constituting noncompliance." In explaining this provision, the preamble to the final regulations states that "it may also be appropriate for one remedy to be imposed for multiple deficiencies that constitute noncompliance. . . ." 59 Fed. Reg. 56116, 56168. In addition, section 488.430(a) provides that "HCFA . . . may impose a civil money penalty for the number of days a facility is not in substantial compliance with one or more participation requirements . . . ." (Emphasis added.)
Accordingly, we reverse the ALJ's finding, in FFCL 10, that he had no authority to impose a civil money penalty based on the three other deficiencies found by the surveyors in addition to the deficiency under section 483.25 because this finding was premised on the ALJ's erroneous finding that HCFA imposed the civil money penalty based solely on the deficiency at section 483.25.
9. The record supports a finding that the three deficiencies found by the surveyors in addition to the deficiency under section 483.25 existed.
HCFA argued that there was no need to evaluate the evidence relating to the three other deficiencies to determine whether they in fact existed since Lake City failed to request a hearing on HCFA's findings of these deficiencies. Accordingly, HCFA argued, "the deficiencies cited under Tags 385, 272 and 279 stand as they are." HCFA Br. at 15. The request for hearing does not refer to the deficiencies found under section 483.20(b) and section 483.20(d). Moreover, the request for hearing refers to only one of the three findings listed by the surveyors under section 483.40(a)(1) and (2) (the finding that Lake City failed to notify physicians of changes in resident conditions which could lead to resident harm).
Lake City nevertheless took the position that it had "challenged the imposition of a [civil money penalty]" and asserted that, at the hearing, "HCFA took the position that the deficiencies [at Tags 385, 272 and 279] were part of the issues in dispute." Lake City Br. at 30, n.17. We need not resolve the question whether Lake City was precluded from challenging the existence of these deficiencies based on its hearing request, however, since we find that the record supports a finding that these deficiencies existed. Specifically, as discussed below, we find that Lake City in effect admitted the existence of these deficiencies, arguing only that the patients in question were not harmed.
Section 483.20(b) requires that "[t]he facility must make a comprehensive assessment of a resident's needs . . . ." The surveyors found that there were incomplete resident assessment instruments in six of eight records reviewed. HCFA Ex. 5, at 3. Before the ALJ, Lake City did not allege that comprehensive assessments were completed as required, nor did it provide any testimonial or documentary evidence of completed assessments. In its brief submitted in response to HCFA's exceptions to the ALJ Decision, however, Lake City took the position that "these citations constitute documentation deficiencies only. . . ." Lake City Br. at 111. Lake City noted that HCFA's witness Ms. Williams testified that the purpose of completing the form is to assess and provide care, and argued that "HCFA failed to present any evidence that the care was not performed . . . ." Id.
Section 483.20(d) requires that "[t]he facility must develop a comprehensive care plan for each resident that includes measurable objectives and timetables to meet a resident's medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment." The surveyors found that the comprehensive care plans they reviewed did not contain measurable objectives to meet identified needs of the residents, failed to address all areas of care as identified on the Resident Assessment Protocol Sheet, and were not timely initiated. HCFA Ex. 5, at 5-6.
Lake City did not allege before the ALJ that the comprehensive care plans contained the required elements or were timely initiated, nor did it provide testimonial or documentary evidence to this effect. Lake City also identified this finding as involving only a documentation deficiency that did not affect the care given to the patients in question. Lake City Br. at 111.
Lake City thus effectively admitted that it did not comply with the requirements at section 483.20(b) and section 483.20(d). Even if Lake City's failure to comply did not harm the patients in question, this would not make the findings of deficiencies under these sections improper. The preamble to the final regulations, addressing the suggestion that "all deficiency citations made by surveyors should include what the negative outcome is," stated that "[a] violation of any participation requirements must be considered a deficiency, even if the violation caused no negative outcome to occur." 59 Fed. Reg. 56116, 56227. In any event, we are not persuaded that there was no negative outcome from Lake City's failure to complete comprehensive assessments or care plans. The fact that the Omnibus Budget Reconciliation Act of 1987, which imposed these requirements, mandated a patient outcome-oriented system indicates that comprehensive assessments and plans of care were regarded as having a direct impact on patient outcome. See 59 Fed. Reg. 56116, 56117. Accordingly, we find that the record establishes the existence of deficiencies under section 483.20(b) and section 483.20(d).

Section 483.40(a) requires that "[t]he facility must ensure that--(1)The medical care of each resident is supervised by a physician; and (2) Another physician supervises the medical care of residents when their attending physician is unavailable." The surveyors found Lake City out of compliance with this requirement on three grounds: that the OTC Protocol did not specify how 101 degrees was to be measured; that physicians failed to review the Physician's Order Sheet, which in two cases erroneously stated that the patient was free of communicable disease; and
that Lake City did not notify the physician of changes in the conditions of Patients 1 and 5. HCFA Ex. 5, at 22-23.
Based on our prior discussion, we conclude that the surveyors incorrectly found a deficiency under this section based on the OTC Protocol. However, we further conclude, also based on our prior discussion, that there was a deficiency under this section based on the same incident (involving Patient 5) which gave rise to the ALJ's finding that Lake City violated the standard of care in section 483.25. Moreover, we conclude that the physicians' failure to review the Physician's Order Sheets constituted another basis for finding a deficiency under section 483.40(a). Lake City did not dispute that the Physician's Order Sheets were not reviewed, but simply argued that "this deficiency posed no greater risk than the potential for minimal harm" since the Physician's Order Sheets were not used by staff to review diagnoses or treatment decisions. Lake City Br. at 107. Lake City pointed specifically to the surveyors' notation that isolation signs were posted on the doors of the patients with infectious diseases notwithstanding the statements in the Physician's Order Sheets. As discussed above, however, a finding of a deficiency is not obviated by the lack of any negative outcome. In addition, HCFA determined that the deficiency under section 483.40(a)(1) and (2) caused actual harm that was not immediate jeopardy. As indicated earlier in this decision, the regulations provide that the level of noncompliance is subject to review only if it would affect the range of the civil money penalty. Since that would not be the case here, HCFA's determination as to the severity of this deficiency is not subject to review.
Accordingly, we substitute the following FFCLs for FFCL 10 (which we reversed as explained in the preceding section):
10. Petitioner failed to comply substantially with the conditions of participation at section 483.20(b), section 483.20(d), and section 483.40(a)(1) and (2).
10a. The deficiencies under sections 483.20(b), section 483.20(d), and section 483.40(a)(1) and (2) must be considered in determining the amount of a lower range civil money penalty against Petitioner based on the deficiency at section 483.25 and are also an independent basis for imposing a lower range civil money penalty.

10. A $500 per day civil money penalty is reasonable based on the factors in section 488.438(f).
In this section, we discuss the amount of a civil money penalty that is reasonable under the applicable regulations. HCFA did not provide a rationale for any particular penalty amount within the lower range in the event that the ALJ or the Board were to decide that a civil money penalty in the upper range was not warranted.
Section 488.438(f) provides:
In determining the amount of penalty, HCFA does or the State must take into account the following factors:

(1) The facility's history of non-compliance, including repeated deficiencies.
(2) The facility's financial condition.
(3) The factors specified in . 488.404 [the severity and scope of the deficiencies].
(4) The facility's degree of culpability. Culpability for purposes of this paragraph, includes, but is not limited to, neglect, indifference, or disregard for resident care, comfort or safety. The absence of culpability is not a mitigating circumstance in reducing the amount of the penalty.
HCFA indicated generally that it considered all of the factors in section 488.438(f) in imposing the $7,500 per day civil money penalty. Lake City's history of non-compliance, its financial condition, the regulations under which deficiencies occurred, and the existence of culpability are unchanged by our findings here. With respect to Lake City's history of noncompliance, the record shows that the September 1995 survey found Lake City out of compliance with the same regulatory provisions as the November 1995 survey (although not on the same grounds in all cases). With respect to Lake City's financial condition, since HCFA determined that Lake City's financial condition permitted a $7,500 per day civil money penalty, payment of a civil money penalty in any lesser amount would clearly be within Lake City's means. With respect to the factors specified in section 488.404, we have determined that Lake City had deficiencies under the same regulations as found by the surveyors. Moreover, while there is no evidence in the record that Lake City's deficiencies were due to indifference or disregard for patient care, the fact that Lake City offered no reason for not completing the comprehensive assessments and plans of care required by the regulations establishes the neglect necessary for finding some degree of culpability.
However, the scope and severity of the deficiencies based on which we impose the civil money penalty differ from the scope and severity of the deficiencies based on which HCFA imposed a $7,500 per day civil money penalty. Not only does the deficiency under section 483.25 not involve immediate jeopardy, but that deficiency was also isolated rather than widespread as found by the surveyors. In addition, there are fewer findings supporting the deficiency under section 483.40(a)(1) and (2). Thus, we conclude that a civil money penalty of $500 per day should be imposed. Accordingly, we add the following FFCL:
11. A civil money penalty of $500 per day for the period November 21, 1995 through December 19, 1995 is reasonable.

11. There is no merit to Lake City's collateral arguments, raised before the ALJ but not resolved, that the surveyors' deficiency findings were invalid.
In its response to HCFA's exceptions to the ALJ Decision, Lake City reiterated several collateral arguments that were raised in its post-hearing brief but not addressed by the ALJ. The ALJ determined that it was unnecessary to resolve these arguments in light of his findings that Lake City was in substantial compliance with section 483.25 and that he lacked authority to impose a civil money penalty based on the other deficiencies found by the surveyors. Since we uphold the ALJ's finding that there was no deficiency under section 483.25 with respect to Patient 1, it remains unnecessary to address Lake City's argument that the survey finding that the care provided to this patient did not comply with the standard of care in section 483.25 was invalid because the individual who made this finding did not receive the training required by section 488.314. In addition, since we determine that the deficiency under section 483.25 did not pose immediate jeopardy, it remains unnecessary to address Lake City's argument that, pursuant to section 488.438(c), the upper range civil money penalty should have been reduced to a lower range civil money penalty as of November 25, 1995 because a surveyor determined during a monitoring visit on that date that there was no longer any immediate jeopardy. We address the remaining arguments below.
Lake City argued that the finding of a deficiency under section 483.25 was invalid because the State survey agency did not conduct an extended survey. Section 488.310(a) requires an extended survey where a facility furnished substandard quality of care. Section 488.301 defines "Substandard quality of care" as one or more deficiencies under section 483.25 (and other sections not relevant here) "which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm that is not immediate jeopardy; or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm." The deficiency under section 483.25 did not fall in any of these categories. Thus, there was no requirement for an extended survey. In any event, sections 1819(a)(2)(B)(iv) and 1919(g)(2)(B)(iv) of the Act provide that "[n]othing in this paragraph [on extended surveys] shall be construed as requiring an extended or partial extended survey as a prerequisite to imposing a sanction against a facility under subsection (h) on the basis of findings in a standard survey."
Lake City also argued that the period for which the civil money penalty was imposed should have ended on December 14 rather than December 19, 1995 (the date of the revisit survey) because Lake City provided credible written evidence in its December 12, 1995 plan of correction that it would be in substantial compliance as of December 14, 1995. However, section 488.454(a) provides that "alternative remedies [including civil money penalties] continue until--(1) The facility has achieved substantial compliance, as determined by HCFA or the State based upon a revisit survey or after an examination of credible written evidence that it can verify without an on-site visit." (Emphasis added.) There is no indication in the record that HCFA determined pursuant to an examination of Lake City's written allegation of substantial compliance that Lake City was in substantial compliance as of December 14. In any event, Lake City provided no proof that it was in substantial compliance as of December 14. Thus, there is no basis for ending the civil money penalty on that date.
Finally, Lake City argued that the September 24, 1995 incident that the ALJ found violated the standard of care in section 483.25 should not have been considered by HCFA in determining whether to impose a civil money penalty because the incident occurred before the October 27, 1995 date of correction of deficiencies found in the September 1995 survey. However, the date of correction for the September 1995 survey is irrelevant because the basis for that survey's finding of a deficiency under section 483.25 was not the same as the basis for the November 1995 survey's finding of a deficiency under section 483.25. Moreover, section 488.440(a) provides that a civil money penalty may start accruing as early as the date that the facility was first out of compliance (as determined by HCFA or the state agency), without any limitation on that date. Accordingly, this argument also fails to provide a basis for reversing the finding of a deficiency under section 483.25.
Conclusion
For the foregoing reasons, we sustain FFCLs 1, 2, 2a, 2b, 3, 5, and 7 and reverse FFCLs 4, 6, 8, 9 and 10. We substitute the following FFCLs for FFCLs 4, 6, 8, 9 and 10:
4. There was one incident in which Petitioner failed to follow professionally recognized standards of care in providing care to Resident 5.
6. As a matter of law, Petitioner was out of substantial compliance with the requirements of 42 C.F.R. . 483.25 between November 21, 1995 and December 19, 1995.

8. There is no basis to sustain a civil money penalty against Petitioner in the upper range of civil money penalties for the period beginning November 21, 1995 and ending on December 19, 1995 premised on Petitioner's failure to comply substantially with the requirements of 42 C.F.R. . 483.25 since that deficiency did not pose immediate jeopardy.
9. A civil money penalty against Petitioner should be imposed for the period beginning November 21, 1995 and ending on December 19, 1995 based in part on Petitioner's failure to comply substantially with the requirements of 42 C.F.R. . 483.25.
10. Petitioner failed to comply substantially with the conditions of participation at section 483.20(b), section 483.20(d), and section 483.40(a)(1) and (2).
10a. The deficiencies at sections 483.20(b), section 483.20(d), and section 483.40(a)(1) and (2) must be considered in determining the amount of a lower range civil money penalty against Petitioner and are also an independent basis for imposing a lower range civil money penalty.

In addition, we add the following FFCL:
11. A civil money penalty of $500 per day for the period November 21, 1995 through December 19, 1995 is reasonable.
________________________
Judith A. Ballard
________________________
Cecilia Sparks Ford
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Donald F. Garrett
Presiding Board Member