Findings Of Fact Background On July 31, 1987, the Department of Health and Rehabilitative Services (HRS) published in the Florida Administrative Weekly an announcement of the fixed need pools for the subject batching cycle, which pertained to the planning horizon of July, 1992. According to the notice, the fixed need pool, which was calculated pursuant to Rules 10-5.008(6) and 10-5.011(m), (n), (o), and (q), Florida Administrative Code, was adjusted according to the occupancy rate thresholds as prescribed by said rules. The net adjusted need for short-term psychiatric beds in District 7 was zero. By letter to HRS dated August 12, 1987, the North Brevard County Hospital District, doing business as Jess Parrish Memorial Hospital (Jess Parrish), provided notice of its intent to apply for a certificate of need to convert 16 beds from medical/surgical to psychiatric. By Application for Certificate of Need dated September 14, 1987, Jess Parrish requested that HRS grant a certificate of need for the conversion of 16 medical/surgical beds to 16 adult short-term psychiatric beds at a cost of $46,100. Jess Parrish is a tax-exempt organization whose board of directors have been authorized by law to levy ad valorem taxes in a special tax district in north Brevard County for the support of the hospital. The main hospital is located at 951 North Washington Avenue in Titusville, which is in north Brevard County. Brevard County is located in HRS District 7. By letter to Jess Parrish dated October 5, 1987, HRS requested additional information. By response dated November 9, 1987, Jess Parrish supplied the requested responses to omissions. By letter dated November 18, 1987, Jess Parrish provided additional information desired by HRS. By letter dated December 22, 1987, Wuesthoff Hospital (Wuesthoff) informed HRS that it objected to the above-described application because of absence of need. The letter states that Wuesthoff maintained an occupancy rate of 74% during the past year in its 25 short-term psychiatric beds. Wuesthoff is located in Rockledge, which is in central Brevard County. By letter and State Agency Action Report dated January 25, 1988, HRS informed Jess Parrish of its intent to issue the requested certificate of need for the conversion of the 16 beds. By Petition for Formal Administrative Hearing filed February 23, 1988, Wuesthoff challenged the intent to award the certificate of need to Jess Parrish and requested a formal hearing. The Application and Approval Process The application for the certificate of need states that Jess Parrish has a total of 210 beds, consisting of 172 medical/surgical beds, 10 obstetric beds, 20 pediatric beds, and 8 intensive care unit beds. The application contains all elements required by law, including a resolution authorizing the application and financial statements. The application and omissions response state that Jess Parrish admitted about 100 psychiatric patients in fiscal year ending 1987. The omissions response adds that Jess Parrish would offer the following programs for its short-term psychiatric patients: continual evaluation, screening, and admissions; individual, family, and group therapy; occupational, recreational, and vocational therapy; psychological and psychiatric testing and evaluation; day hospital and day clinic; family and friends education and support groups; and specialized treatment programs for geriatric psychiatric patients. The omissions response reports that the only facility with adult short-term psychiatric beds within 45 minutes of Jess Parrish is Wuesthoff. The omissions response states that Wuesthoff had experienced the following occupancy rates in its adult short-term psychiatric program: 1984--59%; 1985--66%; 1986-- 7l%; and first three quarters of 1987--71%. The omissions response acknowledges that Jess Parrish and Circles of Care, Inc. (Circles of Care) had jointly prepared the application and that Jess Parrish "plans to employ by contract, Circles of Care, Inc. to operate and manage our unit" if the application is approved. The omissions response includes a letter to HRS dated November 10, 1987, from James B. Whitaker, as president of Circles of Care. The letter describes the 12-year relationship between the two parties, which began when Circles of Care leased its first 12 beds from Jess Parrish between 1974 and 1980. Mr. Whitaker states that the two parties thus "work[ed] out a management agreement; for the new sixteen bed unit that Jess Parrish has requested." In the State Agency Action Report, HRS notes that the project does not conform with Policy 4 of the applicable District 7 Local Health Plan. This policy provides that additional short-term inpatient psychiatric beds may be approved when the average annual occupancy rate for all existing facilities in the planning area equals or exceeds the following rates: adult--75% and adolescents/children--70%. HRS reports a similar discrepancy as to the occupancy standard in the State Health Plan, which incorporates at Objective 1.2 the same 70%/75% standards. HRS states in the State Agency Action Report that the 1986 occupancy rates for short-term psychiatric beds, which averaged 69.98% in Brevard County, were 87% at Circles of Care, 70.6% at Wuesthoff, and 14% at a new facility, C. P. C.--Palm Bay. In addition, for the first six months of 1987, the report states that the occupancy rates, which averaged 63.5% in Brevard County, were 76% at Circles of Care, 71.5% at Wuesthoff, and 43% at C. P. C.--Palm Bay. In calculating numeric need under the rule, HRS concludes that there was a net need for a total of 547 beds in the district, consisting of 312 in specialty hospitals and 235 in general hospitals. Addressing the provision of the District 7 Local Health Plan focusing upon need at the county level, HRS finds that there was a net need for a total of 38 beds. Recognizing the "sub- standard utilization" of existing short-term psychiatric beds, HRS states that the application was justified "mainly because of the enhanced access to services that the project would provide." All of the other criteria were fully satisfied with one irrelevant exception, and the State Agency Action Report concludes: Although the district and county utilization of short-term psychiatric beds falls below the 70% [sic) adult standard, this project merits a Certificate of Need because there exists numeric need in the service area and because the project affords greater access and availability to psychiatric services for underserved groups. Need District and State Health Plans Part 3 of the 1985 District 7 Local Health Plan, published by The Local Health Council of East Central Florida, Inc., sets forth policies and priorities for inpatient psychiatric services. Policy 1 establishes each of the four counties of District 7 as a subdistrict for purposes of planning inpatient psychiatric services. Policy 3 of the 1985 District 7 Local Health Plan provides a specific methodology to allocate beds when the numeric need rule methodology indicates a need for inpatient psychiatric beds. A minimum of .15 beds per 1000 projected population should be allocated to hospitals holding a general license. A total of .20 beds per 1000 projected population may be located in specialty hospitals or hospitals holding a general license. The population projections are for five years into the future. Policy 4 of the 1985 District 7 Local Health Plan provides that additional short-term inpatient psychiatric beds may be approved when the average annual occupancy rates for all existing facilities in the planning area equal or exceed 75% for adult facilities and 70% for adolescents/children facilities. The policy concludes: Additional beds should not be added to the health system' until the existing facilities are operating at acceptable levels of occupancy. Good utilization of existing facilities prior to adding beds aids in cost containment by preventing unnecessary duplication. The 1988 District 7 Local Health Plan, although inapplicable to the subject proceeding, refers to the pending application of Jess Parrish. The plan states: [T]he residents of District 7 appear to be well-served by the existing providers with only a few exceptions. First, residents of north Brevard County (Titusville area) currently have no access to any certified, short-term, inpatient psych services in less than 22 miles. In many driving situations this distance takes longer than 30-45 minutes to traverse. . . . If [the CON that has been tentatively approved] is sustained through litigation and the unit is finally opened availability of these 16 beds should ameliorate, to a large degree, the potential geographic access problems for north Brevard adult/geriatric patients at least. Objective 1.1 of the 1985-1987 State Health Plan states that the ratio of short-term inpatient hospital psychiatric beds to population should not exceed .35 beds to 1000 population. Objective 1.2 states that, through 1987, additional short-term psychiatric beds should not normally be approved unless the service districts has an average annual occupancy of 75% for existing and approved adult beds and 70% for existing and approved adolescents/children beds. Numeric Need Pursuant to HRS Rules Net Need Rule 10-5.011(1)(o)4., Florida Administrative Code, sets forth the HRS numeric need methodology. The rule provides that the projected number of beds shall be determined by applying the ratio of .35 beds to 1000 population to the projected population in five years, as estimated by the Executive Office of the Governor. The relevant projected population for District 7 is 1,564,098 persons. Applying the ratio, the gross number of beds needed in District 7 is 547. The total number of existing and approved short-term psychiatric beds in District 7 in 1987 was 410. There is therefore a net need for 137 short-term psychiatric beds in District 7. The relevant projected population for Brevard County is 441,593 persons. Applying the ratio, the gross number of beds needed in Brevard County is 155. The total number of existing and approved short-term psychiatric beds in Brevard County in 1987 was 117. There is therefore a net need for 38 short- term psychiatric beds in Brevard County. A minimum of .15 beds per 1000 population should be located in hospitals holding a general license, and .20 beds per 1000 population may be located in specialty hospitals or hospitals holding a general license. The calculations disclose that, for District 7, there is a net need of 73 beds in the former category and 65 beds in the latter category. As to Brevard County, the respective numbers are 41 and 4. Rule 10-5.011(1)(o)4.d., Florida Administrative Code, provides that new facilities for adults must be able to project a 70% occupancy rate for the first year and 80% occupancy rate for the third year. Jess Parrish projects that its short-term psychiatric program will experience a utilization rate of 66% at the end of the first complete year of operation and 82% at the end of the third complete year of operation. These projections are reasonable and substantially conform with the requirements of the rule. Rule 10-5.011(1)(o)4.e., Florida Administrative Code, provides that no additional short-term inpatient beds shall normally be approved unless the average annual occupancy rate for the preceding 12 months in a "service district" is at least 75% for all existing adult short-term inpatient psychiatric beds and at least 70% for all adolescents/children short-term inpatient psychiatric beds. HRS considered the 70%/75% occupancy standards in making the July, 1987, announcement of a zero fixed need pool for short-term psychiatric beds in Brevard County. The determination of zero fixed need was a reflection that, although numeric need existed, the occupancy standards had not been satisfied. The incorporation of the occupancy standard into the July, 1987, fixed need calculation represented a deviation from nonrule policy deferring computation of the occupancy levels until the application-review process. The prior announcement of a fixed need pool on February 27, 1987, stated that a number of beds were needed even though the occupancy situation in District 7 was about the same. Subsequent announcements likewise deferred consideration of the occupancy standard. HRS has explicated its nonrule policy of excluding occupancy standards from the calculation of numeric need when publishing fixed need pools. Unlike the relatively simple task of determining the relevant population projection and multiplying it by the proper ratio, application of the occupancy standards, especially at the time in question, required numerous determinations and calculations. By attempting to incorporate the occupancy standards into the calculations upon which the fixed need pool were based, HRS increased the potential for error, which occurred in this case, rather than increased the reliability of the information. Although adequate reason exists for revising the July, 1987, published fixed need pool, Rule 10-5.008(2)(a), Florida Administrative Code, prohibits revisions to a fixed need pool based upon a change in need methodologies, population estimates, bed inventories, or other factors leading to a different projection of need, if retroactively applied. However, the revision of the July, 1987, fixed need pool does not represent a change in need methodologies, population estimates, bed inventories, or other factors leading to a different projection of need, if retroactively applied. The revision to the fixed need pool, which did not represent a change in need methodology or underlying facts, was a result of three legitimate considerations. First, HRS revised the fixed need pool to implement its policy decision to limit the fixed need pool to the numeric need calculation and reserve the calculations of occupancy standards to the application-review process. This consideration does not involve a change in the methodology of determining numeric need or applying occupancy standards. Second, HRS revised the fixed need pool to correct earlier, erroneous calculations. This consideration does not involve a change in the underlying facts, but merely in the computations based upon the same facts. Third, HRS revised the fixed need pool to reflect developing policy in the application of the occupancy standards. HRS decided to apply the more liberal 70% occupancy standard to facilities serving both adults and adolescents/children, exclude from the determination of occupancy levels any facilities serving only age cohorts not served by the applicant, and restrict the 75% occupancy standard to facilities serving adults only. HRS made these changes, which it felt would not harm existing providers, in recognition of the failure of data provided by health-care suppliers to distinguish between adult and adolescents/children admissions and patient days. These considerations approximate a change in methodology, but the revision resulting from such considerations does not violate the rule because HRS already has shown that consideration of the occupancy standards should not take place until after publication of the fixed need pool. In the present case, two facilities in District 7 serve only adolescents/children. These facilities are C. P. C.-- Palm Bay and Laurel Oaks, which is in Orange County. Eliminating their occupancy rates, the district occupancy rate in the year ending June 30, 1987, was 71.9%. Removing the occupancy rate of C. P. C.--Palm Bay from Brevard County, the county occupancy rate during the same period was over 75%. Under the revised policies, Brevard County had a net need of 38 short- term psychiatric beds, applicable occupancy standards in the county and district were satisfied, and the July, 1987, publication of a fixed need pool of zero did not preclude the finding of need under other than "not normal" circumstances. Accessibility Financial Accessibility The primary service area of Jess Parrish is north Brevard County. A higher percentage of the population of this area lives below the poverty level than does the population of any other sub-region of Brevard County. According to the 1980 Census data, the applicable percentages of area residents living below the poverty level were 12.7% in north Brevard County, 10% in central Brevard County, 8.4% in south Brevard County, and 9.6% in Brevard County overall. Partly as a reflection of the different sub-regions and partly as a reflection of the commitment of Jess Parrish to provide access to underserved populations, Jess Parrish provides considerably more services to Medicaid patients than does either of the other major general hospitals in central and south Brevard County. In 1987, 11.5% of the admissions and 8.9% of the patient days at Jess Parrish were Medicaid. The respective numbers are 7% and 6% for Wuesthoff and 5.8% and 3.9% for Holmes Regional Medical Center, which is in Melbourne. A key component of financial accessibility is the effect of the proposed program on Circles of Care. About 55% of the patients of Circles of Care are indigent. Another 17% of its patients earn between the minimum wage and $15,000 annually. Circles of Care has participated in all phases of the application process on behalf of Jess Parrish. The approval of the new program would not have an adverse effect on Circles of Care. To the contrary, the new program at Jess Parrish would provide Circles of Care with more treatment options, especially with respect to indigent patients, whose need for short-term psychiatric services has proven at times difficult to meet. These options are especially valuable at a time when there is no net need in Brevard County for any more short-term psychiatric beds in specialty hospitals, such as Circles of Care. The 52 psychiatric beds licensed to Circles of Care are in two different units contained within a single hospital facility located in Melbourne, which is in south Brevard County. Sheridan Oaks is a 24-bed, private unit, which cannot accept many Baker Act patients without adversely affecting the other patients and the psychiatrists who refer private-pay patients to this unit. The other unit is a public Baker Act receiving facility with 28 beds, for which Circles of Care receives state funds. Unlike Sheridan Oaks, the public receiving facility employs the psychiatrists who work there. About 85-90% of all Baker Act patients in Brevard County come through this public receiving facility, whose occupancy rate was 98% in the year ending June 30, 1987. In addition to these units, Circles of Care operates a mental health outpatient clinic in Titusville, an outpatient/inpatient treatment center in the Rockledge/Cocoa area, numerous social clubs throughout Brevard County for the chronic mentally ill, and numerous public education and awareness programs concerning the treatability of mental illness. Another limitation of being a specialty hospital is that Circles of Care does not qualify for Medicaid reimbursement. Jess Parrish, as a general hospital, qualifies for such reimbursement and projects in its application that 39% of its patient days will be Medicaid and 9% of its patient days will be indigent. Geographic Access Jess Parrish is located at the north end of Brevard County, which runs about 80 miles north-south. Wuesthoff is about 25 miles south of Jess Parrish, and Titusville is about 40 miles north of Melbourne. Intercity north-south traffic uses Interstate 95, which is west of the above-described cities, and U.S. Route 1, which runs through the center of each of these cities. Rule 10-5.011(1)(o)5.g., Florida Administrative Code, provides that short-term inpatient psychiatric services should be located within a maximum travel time of 45 minutes under average travel conditions for at least 90% of the population of the service area. This criterion is presently met without the addition of short-term psychiatric beds at Jess Parrish. This factor is outweighed, however, by another factor in this case. Jess Parrish projects about half of its patients will be indigent or Medicaid, and north Brevard County has a disproportionate share of the county's impoverished residents. Average travel conditions for these persons require public transportation, which, in north Brevard County, is limited to Greyhound/Trailways and local taxi companies. Exclusive of time waiting for the bus and traveling to and from the bus stations, the time for the 25-mile trip between Titusville and Rockledge, of which there are three or four trips daily (excluding off-hour trips), ranges from 25-35 minutes. There is evidence in the record that mentally ill bus passengers do not always make it to their intended destinations by way of intercity buses. The use of available public transportation is therefore problematic, but in any event adds considerable time to the travel time to Wuesthoff for those individuals who do not own a motor vehicle. Effect on Wuesthoff The effect of the conversion of medical/surgical beds to short-term psychiatric beds will have no material effect on Wuesthoff, even though it did reduce the number of short-term psychiatric beds from 30 to 25 in 1986. The occupancy rate for Wuesthoff's short-term psychiatric unit in 1987 was 70.6%. The prime service areas of Wuesthoff and Jess Parrish as to psychiatric admissions do not substantially overlap. Although Jess Parrish may be expected to draw more patients from Wuesthoff's prime service area following commencement of the new operation, many of Jess Parrish's patients will be from the indigent and Medicaid payor classes for which the competition is not intense. The addition of a 16-bed short-term psychiatric unit at Jess Parrish will not materially influence the availability of qualified personnel for Wuesthoff. It appears that Jess Parrish will be able to staff the relatively small 16-bed unit without employing significant numbers of professional employees of Wuesthoff. Some of the relatively few patients whom Wuesthoff can be expected to lose to Jess Parrish involve referrals from Titusville-area physicians, psychiatrists, and psychologists, who will place their patients in the closer facility once it is opened. The negative impact upon Wuesthoff is outweighed in these cases by gains for the patients in continuity of care and community support. Financial Feasibility The short-term financial feasibility is good. Jess Parrish has available to it sufficient funds to undertake the relatively modest capital outlay in constructing the facility, which will consist of about 8000 square feet on an existing floor of the hospital. The long-term financial feasibility is generally good. The financial projections are based on reasonable assumptions, which are largely derived from the actual experience of Circles of Care. The projections accurately estimate revenue sources and expenses. Jess Parrish reasonably projects an adequate supply of patients from a combination of sources, including Circles of Care, existing patients whose diagnoses include psychiatric components, and numerous health-care professionals in north Brevard County. The financial projections contemplate a material contribution by Circles of Care, but project no compensating expenditures. However, this deficiency is largely offset by the likelihood that the financial participation of Circles of Care will be restricted to a share of any excess of revenues over expenses of the new project, possibly excluding reimbursement of fairly minor expenses. If that is the case, the effect of any management agreement would be only to reduce the excess of revenues over expenses enjoyed by Jess Parrish from the operation of the short-term psychiatric unit. The management agreement would not expose Jess Parrish to losses that would not have otherwise existed but for the agreement to make payments to Circles of Care. Under these circumstances, the omission of the information, although material, does not seriously cast into doubt the long-term financial feasibility of the project. Quality of Care The quality of hospital care offered by Jess Parrish is excellent. The quality of the various psychiatric services offered by Circles of Care is also excellent. Both facilities are accredited by the Joint Commission on the Accreditation of Hospitals. The issue in this case involves the quality of care to be expected in the 16-bed short-term psychiatric unit for which Jess Parrish seeks a certificate of need. Circles of Care and Jess Parrish have agreed that Circles of Care will be responsible for recruiting most of the personnel for the new program and will employ the program's medical director, who will be responsible for treatment decisions. In addition, Circles of Care will advise Jess Parrish as to the adoption of policy, which will remain ultimately the responsibility of Jess Parrish. Jess Parrish will employ the head nurse and all other full-time professional staff working in the unit. The tentativeness of the arrangement between Circles of Care and Jess Parrish is partly explained by the desire of both parties to avoid the time and expense of negotiating an agreement in every detail prior to obtaining final approval of the certificate of need. In addition, both organizations were devoting substantial time to the subject litigation, for which Circles of Care was paying a portion of the expenses. In the final analysis, the failure to work out the agreement, although not a positive feature of the application, is not a serious problem for two reasons. First, Circles of Care and Jess Parrish have a long history of mutual cooperation. The relationship began when Jess Parrish leased Circles of Care 16 hospital beds for psychiatric use. Although the arrangement ended several years ago when Circles of Care constructed its Melbourne facility, the two organizations have since cooperated in several less intensive ways. Second, although Circles of Care has superior expertise in the area of mental health, Jess Parrish qualifies by itself to operate the proposed facility. Circles of Care has already provided much of the necessary technical information required for the preparation of budgets and pro formas. Recruiting would probably take somewhat longer without Circles of Care, but the modest construction budget obviously does not involve significant debt service, so that the delay would not be costly. Perhaps the most significant loss from a quality-of-care perspective would be the medical director, whose expertise will be critical. Again, this would be largely a problem of delay only, as Jess Parrish would have to find a replacement, although it appears likely that the director may be Dr. David Greenblum, who is already a member of the active medical staff at Jess Parrish. Given the quality of care provided by Jess Parrish in the past, there is no basis for any concern that, in the unlikely event that the parties fail to negotiate an agreement, Jess Parrish would jeopardize its reputation as a quality 200-bed general hospital in order to commence prematurely a 16-bed short- term psychiatric unit. Other Factors The record does not demonstrate that there are less costly, more efficient, or more appropriate alternatives to the inpatient services proposed in the subject application. There are no crisis stabilization units or short-term residential treatment programs available in Brevard County. The proposed project will have a measurable impact only upon Circles of Care, whose existing inpatient facilities will be enhanced, and Wuesthoff, whose existing inpatient facilities will not be materially affected. In general, these existing services are being used in an appropriate and efficient manner. On the other hand, the beds that Jess Parrish seeks to convert are underutilized in their present designation. The medical/surgical beds at Jess Parrish have been utilized at a rate of less than 60% over the past three years. There are no feasible alternatives to renovation of the existing facilities. The costs and methods of proposed construction are reasonable and appropriate. The approval of the application will foster healthy competition in the area of short-term psychiatric services and promote quality assurance.
Recommendation Based on the foregoing, it is hereby RECOMMENDED that the Department of Health and Rehabilitative Services enter a Final Order granting the application of Jess Parrish for a certificate of need to convert 16 medical/surgical beds to 16 short-term adult psychiatric beds. DONE and ENTERED this 30th day of June, 1989, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 30th day of June, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-1220 Treatment Accorded Proposed Findings of Jess Parrish 1-6 Adopted or adopted in substance. 7-8 Rejected as irrelevant. 9-10 Adopted or adopted in substance. 11 Rejected as recitation of testimony and subordinate. 12-13 Adopted or adopted in substance. Rejected as irrelevant. Adopted to the extent of the finding in the Recommended Order that there likely will be an agreement between Circles of Care and Jess Parrish. Rejected as unsupported by the evidence that such an agreement exists already. Also rejected as unnecessary insofar as the application can stand on its own without the participation of Circles of Care. 15a Adopted or adopted in substance. 15b-15c Rejected as irrelevant. 15d-15g Adopted in substance, although certain proposed facts rejected as subordinate. However, the first sentence of Paragraph 15f is rejected as against the greater weight of the evidence. 15h Rejected as recitation of testimony. 16-18 Adopted or adopted in substance except that all but the last sentence of Paragraph 18g. is rejected as against the greater weight of the evidence and legal argument. 19 First sentence adopted. 19 (remainder) -22. Rejected as subordinate and recitation of evidence. Generally adopted, although most of the facts are rejected as subordinate in the overall finding and cumulative. Adopted except that sixth sentence is rejected as against the greater weight of the evidence and the seventh sentence is rejected as subordinate. Adopted in substance. First sentence adopted. Remainder rejected as irrelevant. Rejected as irrelevant. Adopted. 28a Rejected as unsupported by the greater weight of the evidence. 28b-28d Adopted or adopted in substance. and 31 Rejected as subordinate. Rejected as unnecessary. 32-50 Adopted or adopted in substance. Treatment Accorded Proposed Findings of HRS 1-11 Adopted or adopted in substance. & 14 Rejected as irrelevant. & 15-16 Adopted. 17 Rejected as unnecessary. 18-74 See rulings on Paragraphs 16-50 in preceding section. Treatment Accorded Proposed Findings of Wuesthoff 1-3 Adopted or adopted in substance. Rejected as irrelevant. Rejected as against the greater weight of the evidence and legal argument. 6-10 & 12 Adopted or adopted in substance. 11 Rejected as against the greater weight of the evidence. Rejected as recitation of testimony and cumulative. Rejected as cumulative except that second sentence is adopted. Rejected as recitation of testimony. Rejected as cumulative, subordinate, and legal argument. Rejected as cumulative except that second sentence is adopted. First clause rejected as against the greater weight of the evidence. Remainder rejected as irrelevant. Rejected as cumulative and subordinate. 20-23 Rejected as irrelevant and unnecessary. Rejected as against the greater weight of the evidence. Rejected as irrelevant and unnecessary. Rejected as cumulative. 27-28 Rejected as irrelevant and unnecessary. 29 Rejected as legal argument. 30-32 Rejected as irrelevant. 33-41 Rejected as against the greater weight of the evidence and subordinate. 42 and 51 Rejected as recitation of evidence. 43-45 Rejected as against the greater weight of the evidence. 46 Rejected as legal argument. 47-50 and 52-54 Rejected as subordinate. 55 Rejected as against the greater weight of the evidence. 56-59 Rejected as irrelevant. 60-66 Rejected as subordinate and recitation of testimony. 67-69 Rejected as against the greater weight of the evidence. 70-73 Rejected as against the greater weight of the evidence and subordinate. 74-78 Adopted. 79 Rejected as against the greater weight of the evidence. 80-82 Adopted. 83-85 Rejected as against the greater weight of the evidence. 86 Rejected as subordinate and against the greater weight of the evidence. 87-91 Adopted or adopted in substance. 92 Rejected as against the greater weight of he evidence. 93-94 Rejected as subordinate. Rejected as against the greater weight of the evidence. Rejected as irrelevant. 97-98 Rejected as against the greater weight of the evidence. Rejected as irrelevant. Rejected as subordinate. 101-102 Rejected as against the greater weight of the evidence. Rejected as partly cumulative and partly legal argument. Rejected as against the greater weight of the 105 evidence Rejected and irrelevant. as against the greater weight of the 106-108 evidence. Rejected as subordinate. 109 110-113 Rejected evidence. Rejected as against the greater weight of as subordinate. the 114-117 118-120 Rejected evidence. Rejected as against the greater weight of as irrelevant and subordinate. the 121-122 Rejected as subordinate. 123 124-125 First sentence adopted in substance. Remainder rejected as subordinate. Rejected as subordinate. 126-129 Rejected as unsupported by the greater weight of evidence. the COPIES FURNISHED: Anthony Cleveland W. David Watkins Oertel, Hoffman, Fernandez & Cole, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507 John Rodriguez 1323 Winewood Boulevard Building 1, Room 407 Tallahassee, Florida 32399-0700 William B. Wiley Darrell White McFarlain, Sternstein, Wiley & Cassedy, P.A. Post Office Box 2174 Tallahassee, Florida 32316-2174 Stephen M. Presnell MacFarlane, Ferguson, Allison & Kelly Post Office Box 82 Tallahassee, Florida 32302 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 =================================================================
Findings Of Fact At the commencement of formal hearing, Respondent moved ore tenus to dismiss upon grounds that no disputed issues of material fact existed. Upon representations of Petitioner's counsel that there remained issues of whether or not there had been selective application of the rules to Petitioner (TR 6-7 and 19), of whether or not the license restrictions imposed upon Petitioner duplicated education already completed by the Petitioner at Jackson Memorial Hospital, and a representation that the evidence to be adduced at formal hearing would include educational events up to the date of the de novo formal proceeding sufficient to entitle Petitioner to certification without any probationary period or restrictions (TR 10-12, 16 and 18), ruling was reserved on the motion to dismiss until the completion of Petitioner's case-in-chief. At the conclusion of Petitioner's case-in-chief, Respondent again renewed its motion to dismiss. The motion was denied without prejudice, pending review of the full application file and other documentary evidence admitted in Petitioner's case-in-chief. Respondent has raised the motion yet again in its post-hearing proposals and it is ruled upon in the following conclusions of law. By its January 21, 1987 Order, the Board of Medicine, Advisory Council for Respiratory Care granted Petitioner a license as a respiratory care practitioner subject to the following restrictions: ...the license shall be issued subject to probation upon the conditions: Applicant is not to work in any critical care area, including the emergency room, and, Applicant will not do ventilator care in the home. This probation shall be in force until Applicant has successfully completed an advanced care registry eligibility program with adequate supervision. Said program may be approved by the Chair of the Council. It is stipulated that Petitioner meets standard requirements for licensure. It is disputed as to whether she is entitled to an unlimited/unrestricted license absent the probationary educational requirements. Petitioner received several written and oral warnings relating to incidents of improper patient care while employed at Mount Sinai Medical Center, Miami, Florida, from 1979 to 1982 and prior to making application for her license in 1986. One significant incident involved Petitioner's supervising a student using a sidearm nebulizer and treatment in the Mount Sinai surgical intensive care unit. Petitioner failed to verify information given to her by the student in that she did not personally view the patient and left the room while the treatment was still in the patient. Another significant incident involved Petitioner leaving another sidearm nebulizer in line with a ventilator circuit on a patient. Petitioner admitted her error with regard to these incidents and admitted their inherent danger to patients. The Petitioner was terminated from employment at the Mount Sinai Medical Center on July 21, 1982, for negligence in performance of her duties. Petitioner began work at Jackson Memorial Hospital, Miami, on August 9, 1982. She has maintained continuous employment with Jackson Memorial Hospital up to the date of formal hearing. Until the January 21, 1987 Council Order, Petitioner also worked critical care areas of Jackson Memorial Hospital and did home ventilator therapy for a private company called "Allied." Since January 21, 1987, she has limited her work as required by the licensing order, and since its entry she has performed only duties involving floor care and treatments in the units. Petitioner testified at formal hearing that she successfully completed Respiratory Therapy Theory I and II at Miami Dade Community College subsequent to leaving Mount Sinai, as well as numerous other introductory education courses (TR 35- 36). This testimony is in part contrary to her testimony before the Advisory Council on November 18, 1986. By that prior testimony, she admitted she had not received any clinical course experience of any kind and did not do any ventilating at Jackson Memorial Hospital subsequent to her dismissal from Mount Sinai Medical Center and prior to the Council hearing on November 18, 1986. (Jt. Ex. 2 pp. 59-62) With one exception, all of Petitioner's formal training and clinical training as a respiratory technician for which documentation exists, shows that her training occurred prior to her firing from Mount Sinai in 1982. The one exception is a certificate dated March 16, 1985, showing that Petitioner was found to have fulfilled the educational requirements of the National Board of Respiratory Care, but there is no showing in the record of what these requirements might be or of when they were fulfilled. (Jt. Ex. 1) Petitioner admitted at formal hearing that she has completed no specific course of study and has not completed any advanced care registry eligibility program. The individual subjects she has claimed to have completed since her Mount Sinai experience do not appear to be either clinical or to offer hands- on experience. On periodic Jackson Memorial Hospital Employee Evaluations, Petitioner has received "low" ratings in the categories of "work habits" for the period 8/14/83 to 8/12/84; for "quantity of work" and "personal relations" for the period 8/15/84 to 8/11/85; and again for "work habits" for the period 8/11/85 to 8/10/86. She has "Satisfactory" or "High" ratings in other categories during each of these periods. No proof of arbitrary, capricious, or selective imposition of educational or probationary requirements was demonstrated.
Recommendation Upon the foregoing Findings of Fact and Conclusions of Law it is, RECOMMENDED that the Board of Medicine enter a Final Order affirming its January 21, 1987 Order. DONE and RECOMMENDED this 17th day of December, 1987, at Tallahassee, Florida. ELLA JANE P. DAVIS Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of December, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-1412 The Petitioner's proposals were struck. Rulings upon the Respondent's proposed findings of fact (PFOF) are hereafter ruled upon pursuant to section 120.59(2), Florida Statutes: Respondent's PFOF: 1. Rejected as subordinate and unnecessary and as covered in FOF 1 and 2 and the Conclusions of Law. 2-3. Covered in FOF 3. Covered in FOF 5. Covered in FOF 7. 6-7. Modified in FOF 9-10 to conform to the greater weight of the evidence as a whole and to exclude irrelevant material. 8. Covered in FOF 11. COPIES FURNISHED: Dorothy Faircloth, Executive Director Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750 Gregory F. Esposito, Esquire 5440 North State Road 7 Suite 23 Fort Lauderdale, Florida 33319 Allen R. Grossman, Esquire Department of Legal Affairs The Capitol, Suite 1601 Tallahassee, Florida 32399-1050 William O'Neil, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue to be determined in this proceeding is whether Respondent, Babak Saadatmand, M.D. (Respondent or Dr. Saadatmand), has violated section 458.331(1)(m) and (t), Florida Statutes (2013), as alleged in the Administrative Complaint.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and the entire record of this proceeding, the following findings of fact are made: The Parties Petitioner, the Department of Health, is the agency charged with the regulation of the practice of medicine pursuant to chapters 20, 456, and 458, Florida Statutes. Respondent, Babak Saadatmand, M.D., is a medical doctor licensed by the Board of Medicine. Dr. Saadatmand holds Florida license number ME 114656. Respondent graduated from the University of Maryland, College of Medicine, in 1988, and completed his residency at Case Western Reserve. He then completed a residency in emergency medicine at Cook County Hospital in Chicago, Illinois. Respondent was board-certified in internal medicine, but no longer holds that certification because at the time it was due for renewal, he was no longer eligible because his practice was devoted to emergency medicine as opposed to internal medicine. He remains board-certified in emergency medicine. Respondent has held positions that required him to supervise residents and give lectures at Yale University, New York College of Medicine, and Indiana University. Dr. Saadatmand chose to practice emergency medicine as a traveling physician for the last three years, because of the financial benefits available by doing so while he gained additional experience in emergency medicine. However, he has since or now accepted a position as the assistant program director of the emergency medicine residency program at Jackson Memorial Hospital in Miami, Florida, where his job responsibilities will include the supervision of residents. Dr. Saadatmand holds a medical license in several other states in addition to Florida, and has not been disciplined in any state where he is licensed. Dr. Saadatmand’s Treatment of R.D. In June and July of 2014, Respondent was working as a traveling physician at Parrish Medical Center in Titusville, Florida. While most of his assignments in various emergency facilities have been six months long, the assignment at Parrish Medical Center was for approximately one month. Respondent treated patient R.D. on June 27, 2014, at Parrish Medical Center emergency room. R.D. was accompanied by his wife, C.D. R.D. was a 52-year-old male when he presented to Parrish Medical Center. He had a history of T-cell lymphoma and had been treated for his cancer through the Space Coast Cancer Center. Just days before his presentation to the emergency room on June 27, 2014, he had been cleared to return to his place of employment. However, on June 27, 2014, R.D.’s supervisor called R.D.’s wife, C.D., and asked her to come get R.D. as he was too ill to be at work. R.D. arrived at Parrish Medical Center in the early afternoon, and was triaged by a nurse at approximately 2:13 p.m. The notes from the triage nurse’s assessment recorded, among other things, R.D.’s vital signs upon arrival; his chief complaint, including its duration and intensity; a brief medical history; a list of his current medications; and a drug/alcohol use history. Registered Nurse Sharon Craddock was the emergency room nurse who completed the initial assessment, or triage assessment, of R.D.’s condition. According to her triage notes in the Parrish Medical Center records, R.D.’s chief complaint upon arrival was constipation, which was described as constipation for three days, with bilateral abdominal pain. The pain was described as aching, pressure, shooting, and throbbing, and R.D.’s pain level was reported in Ms. Craddock’s notes as being an eight on a ten-point scale. Her description of his abdomen was “soft, non-tender, round, and obese.” Nurses are directed to record the pain level reported by the patient, and not to alter the pain level based on the nurse’s observation.1/ R.D.’s vital signs were taken upon his arrival at Parrish Medical Center and were recorded in the electronic medical records as follows: temperature, 98.4F; pulse, 127H; respiration, 20; blood pressure, 120/70; and pulse oximeter, 95. The only abnormal reading reflected in R.D.’s vital signs was his pulse, which was above 100, considered to be the upper limit of normal. R.D. reported that he had a medical history which included T-cell lymphoma and that he did not smoke or drink. His current medications were listed as aspirin, Zyrtec, Amaryl, Metformin, Prilosec, Percocet, Pravastatin, and a multivitamin. The Percocet dosage was listed as one tablet, three times daily, as needed for pain. Ms. Craddock also recorded a nursing note for R.D. at 3:37 p.m., and she was in the room when Respondent first went in to see R.D. Ms. Craddock’s nursing note indicates, “Pt with a hx of stomach CA with a recent ‘clean bill of health’ presents with ABD pain and constipation. Occasionally takes Percocet for pain. Wife at BS. Pt. sleepy, states he normally takes a nap this time of day. Pending MD eval with orders.” The Parrish Medical Center chart documents that R.D. was calm, cooperative, and asleep at 15:37 hours (3:37 p.m.). This presentation is generally inconsistent with a patient who is in severe abdominal pain. Dr. Saadatmand saw R.D. at approximately 3:56 p.m. Consistent with the custom at Parrish Medical Center, he worked with a scribe who took Respondent’s dictation for notes during his visit with the patient, and then loaded those notes into the electronic medical record. Respondent would then have the opportunity to review the notes as transcribed and direct the scribe to make any necessary changes. Dr. Saadatmand’s notes indicate that R.D. presented with abdominal pain, and was experiencing moderate pain that was constant with cramping. The description of R.D.’s pain as moderate was based upon Dr. Saadatmand’s observation of R.D. The chief complaint listed was constipation. Dr. Saadatmand took a history from R.D., who reported that he had been diagnosed with gastric lymphoma in 2013, and was treated with radiation and chemotherapy. R.D. and his wife, C.D., reported to Respondent that they feared his cancer might be returning, as his current symptoms were similar to those he experienced when his cancer was first diagnosed. He had returned to Space Coast Cancer Center for some additional screening two to three weeks before the emergency room visit, which included a CT of the abdomen and an upper and lower endoscopy. R.D. and his wife both believed that the results of the screening were normal. Respondent recorded this conversation in the electronic medical record as “[R.D.] had a recent follow up with Dr. Rylander and had normal EGD and colonoscopy. [R.D.] had recent CT scan with cancer center.” Space Coast Cancer Center does not use Parrish Medical Center to perform its CT scans or other testing, so the results of the recent CT scan were not available for Respondent to view. Respondent believed that R.D. and C.D. had followed the directions of R.D.’s oncologists, and R.D. had been a compliant patient. Respondent asked R.D. about his use of Percocet. He did not ask how much he was taking, but how often and whether the use had changed. He considered the answer to this question to be important, because a change in the use could indicate a change in R.D.’s pain intensity. R.D. did not report any change in the amount that he was taking, which was generally an “every other day thing for him.” Respondent testified that, given that the type of Percocet that R.D. was prescribed was an extra-strength as opposed to a standard version of Percocet, it was highly likely that R.D. would suffer from opioid-induced constipation. R.D. reported to Respondent that he had not attempted any laxatives. R.D. also denied having any nausea or surgical history. The lack of a surgical history is significant because patients with a recent surgical history and abdominal pain may be experiencing complications related to the surgery, which would account for the patient’s pain. There is no reference to R.D.’s diabetes in either the nursing triage notes or Dr. Saadatmand’s notes. The only reference in the past medical history is the report of cancer. The list of medications R.D. was taking at home includes Metformin HCI. No evidence was presented to establish whether Metformin is a drug prescribed only for diabetes or whether it is an accepted treatment for other conditions. Moreover, there is no evidence presented to establish how Respondent was to know that R.D. was diabetic if R.D. did not report the condition. In addition to taking R.D.’s medical history, Respondent performed a review of systems and a physical examination, including palpation of his abdomen. In his chart, the electronic medical record states under “review of systems,” “All systems: Reviewed and negative except as stated.” Under the category “Gastrointestinal,” the record indicates “Reports: Abdominal pain, Constipation. Denies: Nausea, vomiting, Diarrhea.” In the physical examination section of the electronic medical record, it is noted that R.D. was alert and in mild distress. The cardiovascular examination indicates that R.D. had a regular rate, normal rhythm, and normal heart sounds, with no systolic or diastolic murmur. With respect to his abdominal exam, Respondent indicated, “Present: Soft, normal bowel sounds. Absent: Guarding, Rebound, Rigid.” The notation that the abdomen was soft with normal bowel sounds is another way of noting that the abdomen is non-tender. Because R.D. was tachycardic upon presentation to the emergency room, Dr. Saadatmand noted R.D.’s anxiety about the possibility of his cancer returning, and checked his pulse a second time. When Respondent checked R.D.’s pulse, it had slowed to 90, which is within a normal range. In light of R.D.’s normal vital signs, normal abdominal examination, and the length of his pain and constipation, Respondent determined that the most likely cause for Respondent’s pain was constipation, and communicated that determination to R.D. and C.D. He asked whether R.D. had used a laxative and was told he had not. Dr. Saadatmand told R.D. and his wife that the pain medication that he took could be a source for his constipation, and that it would be prudent to try a laxative and see if that produced results before considering any further diagnostic tests. Respondent did not order any lab tests for patient R.D. on June 27, 2014, because his vital signs and abdominal examination were normal. He did not order an EKG for R.D. because there were no symptoms to indicate a cardiac issue. Respondent also did not order a CT scan of the abdomen or pelvis for patient R.D. on June 27, 2014. He felt that, in terms of R.D.’s concern about cancer recurrence, there were tests available to R.D.’s oncologist that would be more useful in detecting any recurrence of R.D.’s cancer that are not available through an emergency room visit. For example, a PET scan would be the most helpful, but is not something that Respondent could order through the emergency room because it is not considered an emergent study. The Department has not alleged, and the evidence did not demonstrate, that R.D. suffered from any emergency condition that additional testing would have revealed and that went undetected by Dr. Saadatmand. Respondent did order a prescription-strength laxative, i.e., Golytely, for R.D., which is a laxative commonly used to treat constipation and to prepare patients for a colonoscopy. Dr. Saadatmand communicated his recommendation to R.D. and C.D., who seemed relieved that the problem might be limited to constipation. He also advised them to return to the emergency room should R.D.’s symptoms get worse or if he developed a fever, because those developments would indicate a change in his condition. R.D. received discharge instructions that are consistent with Dr. Saadatmand’s discussion with R.D. and his wife. The discharge instructions referred R.D. to his primary care physician, noted the prescription for Golytely, and provided information related to the community health navigator. The Patient Visit Information sheet received by R.D. specifically noted that the patient was acknowledging receipt of the instructions provided, and stated, “I understand that I have had EMERGENCY TREATMENT ONLY and that I may be released before all my medical problems are known and treated. Emergency medical care is not intended to be a substitute for complete medical care. My Emergency Department diagnosis is preliminary and may change after complete medical care is received. I will arrange for follow-up care.” R.D. also received printed materials about constipation and how to address the problem. These instructions stated that the patient should contact his or her primary care provider if the constipation gets worse, the patient starts to vomit, or has questions or concerns about his or her condition or care. It also instructed the patient to return to the emergency room if he or she had blood in his or her bowel movements or had a fever and abdominal pain with the constipation. R.D. signed the acknowledgment that he had read and understood the instructions given to him by his caregivers. The acknowledgment specifically referenced the instructions regarding constipation. The written instructions are consistent with the verbal advice provided by Respondent. R.D.’s Subsequent Treatment Unfortunately, R.D.’s symptoms did not improve. He developed a fever and his pain level increased significantly. As stated by his wife, his pain the following day was “way worse” than when he saw Dr. Saadatmand. After a call to her niece, a nurse that worked in the emergency room at Parrish Medical Center, C.D. took R.D. back to the hospital on June 28, 2014, at approximately 6:30 p.m. At that point, he had a heart rate of 125, a temperature of 101.6 degrees, and tenderness in the lower left quadrant of his abdomen. Testing indicated that R.D. had intra-abdominal masses and small collections of extra-luminal gas that suggested the possibility of a contained micro-perforation. There is no allegation in the Administrative Complaint that the micro- perforation existed at the time R.D. saw Respondent. R.D. died on August 23, 2014, as a result of end-stage T-cell lymphoma. The Expert Witnesses The Department presented the expert testimony of Annie Akkara, M.D. Dr. Akkara is board-certified in emergency medicine and has been licensed to practice medicine in Florida for approximately nine years. All of her practice has been in the greater Orlando area in the Florida hospital system. She worked full-time for one year when she first moved to Florida, and since that time approximately 80 percent of her practice has involved reviewing medical charts for Veracode Associates, to determine whether diagnostic codes are fully supported in the medical records. She takes emergency room shifts on an as-needed basis, and has supervisory responsibility over patient extenders, such as nurses and physicians’ assistants, but not over other physicians. Dr. Akkara has never served on any committee for a medical staff at a hospital or helped develop protocols for an emergency room, and has not conducted any type of medical research. Although her position requires her to review electronic medical records, she was not familiar with the program used by Parrish Medical Center. Dr. Akkara reviewed the medical records for the emergency room visits for both June 27 and 28, 2014, as well as the records from the inpatient admission after the June 28 visit. She also reviewed the expert witness reports of Drs. Orban and Smoak. Dr. Saadatmand presented the expert testimony of David Orban, M.D. Dr. Orban practices emergency medicine in the Tampa area. He attended medical school at St. Louis University and completed residencies in orthopedics and emergency medicine. Dr. Orban has been licensed to practice medicine in Florida since 1982 and has been board-certified in emergency medicine since 1981. Before he practiced in Florida, Dr. Orban served as an instructor in surgery at the Washington University School of Medicine, and from 1970 through 1983, was an assistant professor of medicine at the University of California, Los Angeles (UCLA). In that position, he supervised residents in the emergency medicine program and helped to develop the program’s curriculum. Dr. Orban left UCLA in 1983 and moved to Florida, in order to help establish the emergency medicine residency program at the University of Florida. Currently, Dr. Orban is the director of emergency medicine for the University of South Florida (USF), College of Medicine, and the Medical Director Emeritus for the Tampa General Hospital Emergency Room. The USF emergency medicine residency program is a competitive program which receives approximately 1,200 applications each year for ten residency positions. Dr. Orban continues to spend approximately 20-24 hours each week practicing in the emergency room, in addition to his teaching responsibilities. He both sees patients on his own and supervises residents who are seeing patients. He has extensive experience in evaluating non-traumatic abdominal pain in the emergency room.2/ Allegations Related to the Standard of Care Dr. Akkara testified that in her opinion, Dr. Saadatmand’s care and treatment departed from the standard of care in a variety of ways. She agreed that Respondent assessed R.D.’s abdomen, but believed that he erred in not specifically documenting that the abdomen was not tender. In this case, the patient record specifically states, “Abdominal exam: Present: Soft, Normal bowel sounds. Absent: Guarding, Rebound, Rigid.” In Dr. Akkara’s view, the notes should have been more specific, and she found fault with the fact that the notes did not use the words “tender” or “non-tender.” Dr. Orban, on the other hand, noted that Respondent specifically documented the absence of guarding, rigidity and rebound tenderness, and described the abdomen as “soft, with normal bowel sounds.” Dr. Orban testified that assessing an abdomen for guarding, rigidity, and rebound are all forms of checking for abdominal tenderness. He did not hesitate to interpret Respondent’s medical records for R.D. as reflecting a normal exam, meaning no tenderness was discovered. Dr. Orban’s opinion is supported by the differences in the medical records from R.D.’s June 27 and 28 emergency room visits, and what options are provided in the electronic medical record when a positive finding for tenderness is chosen. Dr. Orban’s testimony is credited. The Administrative Complaint alleges and Dr. Akkara opined that Respondent departed from the appropriate standard of care by failing to obtain a complete set of normal vital signs before R.D. was discharged from the hospital. The only vital sign that was ever abnormal during R.D.’s June 27 visit was his heart rate, which upon arrival was 127. Respondent rechecked R.D.’s heart rate when he examined him, and upon re-examination it was 90, well within normal limits. Dr. Orban did not believe that the standard of care required the physician, as opposed to possibly supportive staff, to obtain a complete set of vital signs prior to ordering a patient’s discharge. The evidence established that while there is sometimes a nursing standard in emergency rooms requiring a nurse to obtain a second set of vital signs before a patient is discharged, there is no corresponding standard that requires the physician to repeat all of the vitals as well. Dr. Akkara admitted that while she attempts to get a complete set of vital signs before she discharges a patient, she does not always succeed in doing so. The evidence did not demonstrate a departure from the standard of care for not obtaining a second set of vital signs prior to discharge, especially where, as here, all of R.D.’s vital signs were normal when he arrived at the emergency room, except for his heart rate, and Dr. Saadatmand did, in fact, re-assess R.D.’s heart rate prior to discharge. The Administrative Complaint alleges that Respondent fell below the standard of care by not ordering routine lab work for R.D. The Administrative Complaint does not allege what purpose the routine lab work would serve in the emergency treatment of R.D. Dr. Akkara testified that routine lab work should have been completed before discharge, and that it was a departure from the standard of care not to do so. She stated that the labs were necessary to assess white blood cell count, glucose levels, and kidney function, and in those cases where tenderness was noted in the upper right quadrant of the abdomen, also could indicate issues with the patient’s liver enzymes. Dr. Akkara acknowledged, however, that it is possible for a CBC (complete blood count) to be frequently misleading in patients with abdominal pain, and is often normal with patients with appendicitis. Blood work often cannot distinguish between serious and benign abdominal conditions, and Dr. Akkara admitted that with respect to R.D., given the records from the subsequent admission, any results from a CBC ordered on June 27 would not have altered the treatment of the patient or changed his ultimate outcome. Dr. Orban testified that in the majority of cases where a CBC is ordered in the emergency room, it is not helpful. Ordering a CBC is helpful where a patient has a fever because it would help identify infection, or where a patient appears anemic. Other than those instances, it is not all that useful and is over-utilized. A chemistry panel measures a patient’s serum levels for things like sodium, creatinine, and glucose. Dr. Orban testified that, even with a diabetic patient, unless the patient is experiencing vomiting, mental status changes, blurred vision, frequent urination, or other symptoms associated with diabetes, a blood chemistry panel would not be helpful for assessing a patient with non-traumatic abdominal pain. Records for R.D.’s June 28 visit (the day after Respondent saw R.D.) note that he was diabetic, while the June 27 records do not. However, it was not established that either R.D. or his wife ever told anyone, whether nursing staff or Dr. Saadatmand, that he was diabetic. There is no testimony that his prescription for Metformin was to treat diabetes, as opposed to some other condition, and there was no evidence to indicate that diabetes is the only condition for which Metformin can be prescribed. Dr. Akkara repeatedly referred to R.D.’s diabetes as a basis for her opinions, but never identified the records that formed a basis for her knowledge of R.D.’s diabetic condition. The evidence presented does not establish that ordering a blood chemistry or CBC was required by the appropriate standard of care related to the care and treatment of R.D. in the emergency room on June 27, 2016. Dr. Akkara also testified that Respondent departed from the standard of care by failing to obtain a CT scan of the abdomen and pelvis. Her opinion is based, at least in part, on her belief that Respondent failed to document that R.D.’s abdomen was non-tender. She agreed with Dr. Orban that if a patient has no abdominal tenderness, then a CT scan is probably not warranted. In addition, Dr. Orban testified credibly that over the last ten years, there has been a trend toward over-utilization of CT scans, with the concomitant increased risk of radiation- induced cancer. In this case, R.D. had reported having a CT scan just weeks before this emergency room visit. His abdomen was not tender. In a case such as this one, where the patient presents with non-traumatic abdominal pain and a normal abdominal examination and no fever, a CT scan is not warranted. Dr. Orban’s testimony is credited. There is not clear and convincing evidence to establish that the standard of care required Respondent to order a CT scan under the circumstances presented in this case. Dr. Akkara testified that Respondent also violated the standard of care by not ordering an EKG for R.D. However, she acknowledged that R.D. did not present with any cardiac-related symptoms and denied chest pain. The purpose of an EKG is to explore any cardiac-related symptoms, and R.D. did not present with any. Dr. Akkara did not provide any protocols that dictate when an EKG should be ordered. Dr. Akkara also acknowledged that ordering an EKG would have no impact on the care provided to R.D., and that a patient does not need an EKG just because he or she walks in the emergency room with tachycardia.3/ The Department did not establish that the failure to order an EKG violated the applicable standard of care in this case. The Department also has charged Respondent with failing to arrange for follow-up care and failing to discuss follow-up care, as well as reasons for R.D. to return to the emergency room, if necessary. However, as noted in paragraphs 32-34, Dr. Saadatmand discussed follow-up care with R.D. and told him what circumstances would require a return visit to the emergency room. Dr. Akkara acknowledged that the discharge instructions given to R.D. were adequate. As stated by Dr. Orban, the role of an emergency room physician with regard to the assessment of patients is to identify emergency situations and treat them. Emergency situations are those that are acute, rapidly decompensating, and that require either medical or surgical intervention, with most likely a hospital admission for more definitive care. It is not the emergency physician’s responsibility to manage a patient’s chronic conditions. It is routine to advise patients with non- acute conditions to follow up with their established physicians and to provide written instructions to that effect. Dr. Saadatmand’s actions in providing instructions, both in terms of follow-up and possible return to the emergency room, were consistent with the standard of care. Finally, the Administrative Complaint finds fault with Dr. Saadatmand for not conducting another abdominal examination and not re-assessing R.D.’s vital signs prior to discharge. As noted previously, the only vital sign that was abnormal when R.D. arrived was his heart rate. Respondent did re-assess R.D.’s heart rate prior to discharge, and it was normal. With respect to a second examination of Respondent’s abdomen, the Department did not establish that one was necessary. Here, Respondent’s initial examination was normal, and there was a reasonable explanation for his discomfort that Respondent believed needed to be addressed before going any further. Dr. Akkara offered no protocol or other authority other than her own clinical experience to support the opinion that serial examinations of the abdomen were required. On the other hand, Dr. Orban testified that where, as here, where the first examination was normal and there was no fever or vomiting, no second examination would be required.4/ Dr. Orban’s testimony is credited. In summary, the Department did not establish that Respondent violated the applicable standard of care in his care and treatment of R.D. Further, his medical records, while not perfect, justify the course of treatment provided in this case.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 5th day of December, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 5th day of December, 2016.
The Issue The issue in this case is whether an application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital (“Wolfson”), to operate a pediatric trauma center should be approved.
Findings Of Fact The following findings of fact are derived from the stipulation of the parties, the admitted exhibits, and the testimony at final hearing. DOH is the state agency responsible for, inter alia, the review and approval (or denial) of applications to operate trauma centers, including pediatric trauma centers. DOH denied the trauma center application filed by Wolfson, not due to an absence of need in the area, but due to Wolfson’s failure to comply with some requirements set forth in the application. Wolfson is a 216-bed not-for-profit children’s hospital located in Jacksonville, Duval County, Florida. It is part of the Baptist Health organization and is one of three hospitals operated under that entity’s license. Wolfson is located on the same campus as Baptist Medical Center – Jacksonville. The two hospitals share a pharmacy which is located in the children’s hospital and a laboratory located in the adult hospital, but no other services or staff. Interestingly, Wolfson was developed by the sons of Morris Wolfson, a Jewish immigrant to the United States. One of Mr. Wolfson’s children had died at an early age due to lack of access to health care services. Later in his life, after acquiring a small fortune from his business, Mr. Wolfson asked his five remaining sons to develop a children’s hospital accessible to every child, regardless of race, creed, or religious affiliation. By 1951 the sons had raised over half a million dollars and were prepared to construct a hospital. They approached the Baptists, who agreed to build the children’s hospital as part of their development of Baptist Hospital. In 1955, Mr. Wolfson’s dream became a reality. Wolfson provides a wide range of services to children, including but not limited to: two neonatal intensive care units; cardiac catheterization; open heart surgery; bone marrow transplants; and extracorporeal membrane oxygenation, a less complex bypass procedure. There is an emergency department at Wolfson. It receives approximately 60,000 patients per year. Wolfson also operates three satellite emergency departments and has three mobile ICUs (known as “Kids Kare” mobile units). Wolfson’s service area is quite large, comprised of a triangle identified by the vertices of Savannah, Georgia – Dothan, Alabama – and Daytona Beach, Florida. About ninety percent of Wolfson’s patients come from within that area. There is not currently a pediatric trauma center in Jacksonville, which is located in Trauma Service Area (“TSA”) 5. There are five counties in TSA 5: Duval, Baker, Clay, Nassau, and St. Johns. The closest pediatric trauma center to Jacksonville is located in Gainesville, Alachua County, Florida, some 60 miles away. There is a Level II trauma center located at UF Health Jacksonville, but it is not specifically for pediatrics. There are differences in the provision of care to pediatric patients versus adult trauma patients, including specialized equipment, age-appropriate drugs, and modified procedures. Pediatric trauma patients from TSA 5 must be transported to UF Health Jacksonville or Shands in Gainesville. Some of those patients are designated as “trauma alert patients.” Those are individuals identified by emergency medical services as requiring immediate, high-level treatment by skilled professionals. Not all trauma patients are trauma alert patients. Once a pediatric trauma patient has been stabilized at UF Health Jacksonville or Shands, the patient can be transferred to Wolfson for further treatment. Wolfson then undertakes the care needed by the patient. UF Health Jacksonville transfers about 20 to 30 pediatric trauma patients per month to Wolfson. Not all of those patients have previously been deemed trauma alert patients, but Wolfson has extensive experience treating patients with significant needs. It is Wolfson’s desire to operate its own pediatric trauma center, thereby obviating the need for a trauma patient to first go to UF Health Jacksonville or Shands before being transferred. There are times when a delay in transfer can have negative consequences for the patient. The number of such occurrences was not quantified by Wolfson, but Wolfson considers it a significant problem. There is, by rule, a very precise process for a hospital to obtain verification as a trauma center. There are three stages to the process: provisional review, in-depth review, and site visit. Hospitals are given only one opportunity each year to apply for verification. In order to apply, a hospital must file a letter of intent (“LOI”) between September 1 and October 1. On or before October 15, the Department sends an application package to each hospital which had timely submitted an LOI. After receiving the application package, a hospital has until April 1 of the following year to complete and submit the application. DOH must complete its provisional review of the application and notify the applicant, by April 15, of any deficiencies which should be addressed. The hospital then has five business days to submit clarifying or corrective information. In accordance with this process, Wolfson timely filed its application to operate a pediatric trauma center. By rule, the application must contain responses and support relating to nineteen “critical elements” related to trauma care. The Department then reviews the application to make sure that all minimum standards for approval have been met. An applicant is not required to necessarily satisfy each element or subpart of a standard in order for it to be approved by the Department. However, failure to comply with a critical element overall can result in denial of the application. The initial review of an application by the Department is extremely important because, if provisionally approved, the applicant can immediately commence operating as a trauma center. In the present case, Wolfson’s application was reviewed by two persons under contract with the Department: Dr. Robert Reed and Susan Cox, RN. The Department deems each of those persons to be an expert in the field of trauma care based on their background and training. The provisional review by the reviewers was for the purpose of determining whether the application was complete and whether the hospital satisfied the critical elements required for a trauma center. After completion of their initial review, the reviewers sent a letter to Wolfson identifying certain deficiencies they had found in the application. There were a number of deficiencies identified by Dr. Reed and Nurse Cox in Wolfson’s application. However, the most important of those (and the ones at issue in this proceeding) were as follows: Standard II.B.1.b relates to trauma-related continuing medical education (“CME”) requirements for emergency physicians; Standard XVII relates to required multidisciplinary conferences which must be held throughout the year; and Standard XVIII addresses Quality Management a/k/a Quality Improvement (“QI”), also referred to as Performance Improvement. Wolfson was given an opportunity to address each of the stated deficiencies and did, in fact, submit some additional information. Despite the additional information, Wolfson’s application was still deemed insufficient and was denied. The Department now concedes that the CME standard was satisfied in Wolfson’s application. The same is true for the standard relating to multidisciplinary conferences. The QI standard (Standard XVIII), however, remains in dispute. DOH contends that the information submitted by Wolfson in its initial application and deficiency response falls short of proving compliance with this critical element. The QI standard requires a system of procedures and protocols that will promote performance improvement while maintaining patient safety. The goal is to establish processes to ensure a hospital is continually improving the quality of care provided. The subparts of the QI standard require detailed demonstrations of various processes, including: A.2 – A clearly defined performance improvement program for the trauma population; – Review of all trauma patient records from five specified categories; – Monitoring of six indicators relevant to the respective facility (which are in addition to four state-mandated indicators); – Review of cases relevant to the six indicators by the trauma medical director (“TMD”) and trauma program director (“TPD”), to decide whether the cases should be referred to the quality management committee (“QMC”). B.5 – Evaluation by QMC of the effectiveness of action taken to ensure problem resolution; – Preparation and submittal of a quarterly report showing which cases have been selected for corrective action; and – Maintenance of an in-hospital trauma registry with information on patients being treated. The gist of Wolfson’s QI program is set forth on a flow chart contained in the application. That chart is entitled, “Trauma PI Process: Levels of Review.” Though not explained at final hearing, the “PI” in the chart is presumably “Performance Improvement.” The flow chart indicates there to be a primary (daily) review, a secondary (weekly) review, and a tertiary (monthly) review involving certain designated persons. In each of the “boxes” for the respective reviews, there is a stated purpose for the review. For the primary review, the purpose is stated as: Identification of opportunities for Improvement/Validation. The secondary review’s purpose is: Adverse Event/Audit Filter Review. And the purpose of the tertiary review is: Peer Review/Accountability Determination, Loop Closure Plan, Trended Data Review. Phases of care identified in the flow chart are: Pre- hospital, Resuscitation, Inpatient Care Review, and Readmission Review. There is a list of “actions” in the flow chart: Education; Counseling; Trend Report; Guidance/Policy/Protocol Development; and Hospital PI Project. From that list, there is an arrow pointing back toward the primary review box. There is no narrative in the flow chart to explain how the various boxes interconnect or how the information therein ties to the requirements as outlined in the application form. Wolfson asserts that all relevant information is contained in the flow chart, whether in narrative form or not. There is also additional information in the application, attached as a “Scope of Services” addendum, which further elucidates what is found in the flow chart. The Department deems the flow chart and scope of services information insufficient for determining whether the proposal satisfies the critical elements. Wolfson says the flow chart is a “clearly defined performance improvement program.” It is, in fact, only an outline of a clearly defined program. The testimony provided at final hearing by Wolfson’s TPM explained how that outline would work to improve performance. With that explanation, the flow chart/scope of service information minimally satisfies this critical element of the application. Wolfson maintains that the information provided supports the requirement for review of all records from five specified categories, i.e., all trauma alert cases, critical or ICU admissions, operating room admissions for traumatic injury, critical trauma transfers, and in-hospital deaths. Upon review of the flow chart there is insufficient evidence concerning those five areas. However, the scope of information addendum at least minimally refers to those areas as part of the review process. The flow chart/scope of service information addresses the four state-required indicators. The other six indicators required in the application are listed as “to be determined by the [Quality Management] committee.” Wolfson points out that in the minutes from a QMC meeting in February (which was included in the application), nine additional indicators are listed. So, although not easily found, the application does provide sufficient response to the required element. The application is also supposed to identify cases relevant to the six selected indicators in order to determine whether any of those cases should be referred to the QMC. The determination to refer cases is followed up by an evaluation of the effectiveness of actions taken by the committee. The flow chart can be interpreted to address this requirement, but it is fairly nebulous. The scope of services information provides some additional support, but only in general terms. The required quarterly reports are supposed to show which cases have been selected for corrective action by the committee. Wolfson asserts that it cannot submit any such reports until it is operating as a pediatric trauma center, i.e., until it actually has patient cases to report. That position is plausible. The Department did not provide any evidence as to how other applicants satisfied this requirement, so Wolfson’s position cannot be measured against other providers.1/ The same is true as to the requirement for an in- hospital registry of information concerning patients who are being treated. Wolfson has purchased the software needed to commence its registry once patients are being admitted, but it cannot do so at this time, again because it has no such patients. All things considered, Wolfson’s application was not a superlative response to the question of its abilities, but it at least minimally met the requirements for approval of a provisional license. Considering, de novo, all of the evidence concerning Wolfson’s proposed trauma center operations, the application is complete. Wolfson provided extensive testimony and evidence as to the need for a pediatric trauma center in the service area and its willingness and ability to meet that need. There is no doubt that, if approved, the pediatric trauma center would be beneficial to the area. However, need was not an issue in the proceeding.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent, Department of Health, enter a Final Order approving the pediatric trauma center application filed by Petitioner, Southern Baptist Hospital of Florida, Inc. d/b/a Wolfson Children’s Hospital. DONE AND ENTERED this 14th day of November, 2017, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of November, 2017.