Findings Of Fact Valaria Alsina has been licensed as a medical physician in Florida since 1976 and was so licensed at all times here relevant. On August 19, 1980, Elsa Trujillo and her daughter Nancy, age 12, visited the office of Respondent for treatment. This was the initial visit to Respondent by these patients. Patient histories in Exhibit 3 for Elsa show the first entry to be October 7, 1980; however, the language used in this history clearly shows this to be not Elsa's first visit. Respondent's testimony and reports submitted by Respondent to Petitioner, Exhibit 3, reveal initial complaints by this patient to be dizziness, urinary tract infection, vomiting, vaginal discharge, headache, depression, burning sensation while voiding, and dark urine. Respondent did a urinalysis, took blood for testing, did a PAP smear and vaginal irrigation. Other treatment rendered this patient was not disclosed. The skin and blood tests performed constitute the gravamen of the charges here involved. In Exhibit 1 Respondent billed the insurance carrier for Elsa $359.50 for this visit of August 19, 1980. Those blood tests, the necessity for some of which is questioned by Petitioner, are for glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including sodium, potassium, chlorides, and carbon dioxide) total protein, bilirubin, and albumin. The reason the need for these tests is questioned is because they were billed to Prudential Insurance Company as individual tests for each of which Respondent billed from $10.00 to $20.00. These tests are normally performed by medical laboratories in groups, automatically, in which testing machines are programmed to do certain tests on one blood sample introduced into the testing machine. These automatic testing procedures are generically designated "SMA" and are known as SMAC-6, SMAC-16, SMAC-26, etc., with the number denoting the number of tests performed. Those blood tests performed on the Trujillos are all included in the SMAC-22 program for which a laboratory normally charges the doctor $10-$12. Had these tests been charged as SMAC-22, the fact that several were unnecessary would have been accepted because, as a SMAC-22 neither physical nor financial harm resulted to the patient from the unnecessary blood tests conducted. The SMAC-22 could have been performed as cheaply as or cheaper than two manual and individual tests. Since Petitioner's expert witnesses both agreed that some of the tests conducted on this patient were indicated from the symptoms presented, the only fault they found was in Respondent's performing, and charging the patient for, individual and manual blood tests for which there was no medical justification. Nancy Trujillo was seen by Respondent on August 19, 1980. For this visit Respondent billed Prudential Insurance Company $262.50. Clinical data prepared by Respondent for Nancy shows usual childhood diseases, tonsillectomy, adenoid-ectomy, fever, sore throat accompanied by ear pains and swelling, patient complaining of weakness, history of anemia, poor appetite, burning sensation when voiding, dark urine, and a skin rash on right leg. Patient's weight was recorded as 70 pounds, but neither height nor temperature was recorded. In addition to a complete physical examination, a urinalysis, skin culture, and sensitivity test were done, and blood chemistry tests included complete blood count, calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. These blood tests, all of which (except the cbc) are included in a SMAC-22, were billed as having been performed as individual tests at costs ranging from $10.00 to $17.50 each. Treatment prescribed for Nancy consisted of aspirin suppositories. Respondent testified that Nancy was under weight, although her height was not measured, and that she took Nancy's temperature but failed to record it. Jose Trujillo was seen by Respondent on February 4, 1981, as a patient. Clinical data recorded by Respondent on this visit (Exhibit 3) include ". . . history of diverticulitis of colon, states that have diet but feels like some abdominal discomfort accompanied by diarrhea and feels weak. Patient with history of admission in the hospital, admission Palmetto General Hospital. Some lower discomfort abdomen and dark urine." For this visit prudential Insurance Company was billed $340 for complete physical examination (genital exam omitted) complete blood count; urinalysis; blood tests including glucose, BUN, creatinine, calcium, phosphorus, uric acid, electrolytes (including calcium, potassium, chlorides, and carbon dioxide) total protein, cholesterol, triglycerides, SGOT, SGPT, and alkaline phosphates; urine culture; sensitivity test; and collection and handling. The blood tests were all included in a SMAC- 22 but were billed as individual and manually performed tests with costs ranging from $10.00 to $20.00 each. Petitioner's expert witnesses both testified that some of the tests performed on these three patients were indicated by the symptoms and complaints described. Other tests conducted were not appropriate for the symptoms given. They also agreed that had these tests been conducted and billed as a SMAC-22 they would not consider that that could be a violation of the Medical Practices Act because, even though some of these tests were not medically indicated, they "come with the package" and would not increase the cost to the patient. However, when conducted manually and individually and so billed, the practice of conducting blood tests for which there is no medical justification does not conform to the generally prevailing standards in the medical community. Because of the findings below, it is unnecessary to denote those tests performed on each of the Trujillos for which there was no medical justification. Although billed to Prudential Insurance Company as manually and individually performed, the blood tests on the three patients above-named were conducted as a SMAC-22 and were not performed manually and individually as testified to by Respondent. This determination is based on the following facts, circumstances, and rationalizations: Respondent sent the blood samples from these three patients to Central Medical Laboratory, Inc., for a SMAC-22 test. Respondent testified that she performed each of the series of 10 to 15 tests on the blood samples of these patients in 20 to 30 minutes; however, other medical witnesses testified it took a trained technician 20 minutes to perform one of these blood tests manually. The latter testimony is deemed more credible. Many of these tests have subjective characteristics, such as color comparisons, and identical results from the same blood sample tested by two technicians or run through the same automated process would be rare. The odds against a technician performing individual and manual tests on 16 blood samples and obtaining the identical result on all tests that is obtained from a commercial laboratory SMA test is astronomical. Yet, the one report obtained from Central Medical Laboratory for the SMAC-22 conducted on the blood sample from Jose Trujillo (Exhibit 7) is identical to the "manual and individual" test report maintained by Respondent for the same blood sample in Exhibit 3--with one exception. The laboratory found the triglyceride test to be 254 MG/DL, well outside the 30-175 range for this test. On Exhibit 3 Respondent recorded 175 for this test. She testified she sent blood samples from the three Trujillos to the laboratory to have a check on her tests but did not ask the laboratory to do a recheck on the triglycerides test on Jose or recheck her test for triglycerides after receiving the laboratory report. Only a small amount of blood (5 or 10 cc) is required for an automated procedure for up to 40 different tests, whereas at least three times this amount of serum would be required for 10 tests conducted manually or individually. Accordingly, manual testing would require the drawing of a lot more blood than would be required for automated testing in a commercial lab. Respondent testified that she sent one-half of the blood sample taken on each Trujillo to the laboratory and kept the other one-half to test in her office. Commercial medical laboratories are licensed by the state; are checked for compliance with proper procedures; equipment used is checked for proper calibration at frequent intervals; reagents used in the testing is frequently replaced; and, when compared to the equipment, procedures, calibration, and reagents used in a physician's office which are subject to no regulation, the former should provide the more reliable test in a much shorter time. The equipment in Respondent's office is capable of being used to conduct all of the tests on these three patients for which Respondent billed Prudential Insurance Company. No rational explanation was provided to justify having a SMAC-22 performed and duplicating these tests manually. Respondent's testimony that the SMAC-22 was ordered to check the results of the manual tests she performed is not credible. If a check on the manual tests conducted on blood samples of Nancy and Elsa Trujillo for the August 17, 1980, visit was desired, it would appear appropriate to check the office procedures by doing a SMAC-22 on only one of those blood samples, rather than have both of these samples checked as was done here. Repeating this "check" on the sample taken from Jose Trujillo on February 4, 1981, does not make sense. Either the laboratory test is trusted or it is not. The same applies to the individual tests conducted manually in the office. If confident of the procedures, there would be no reason for Respondent to check the manual tests conducted in the office by sending one-half of the serum to a commercial laboratory. Respondent testified that Central Medical Laboratory picks up blood samples at her office daily. This suggests that some tests are routinely ordered by Respondent and conducted by the laboratory, and no evidence was presented to rebut such a conclusion. On the other hand, Petitioner presented no evidence of the volume of tests conducted by Central Medical Laboratory for Respondent which would solidify this conclusion. Nor did Petitioner submit the SMAC-22 results obtained by Central Medical Laboratory for the blood test conducted on the serum taken from Elsa and Nancy Trujillo on August 17, 1980, to see if they too were identical to the results shown in Exhibit 3. The only rational explanation for having SMAC-22 tests performed in a commercial laboratory and reporting these tests as done individually and manually in Respondent's office is the amount the insurance company will pay for the latter is nearly ten times what they will pay for the former. Laboratory tests billed for Jose Trujillo for the February 4, 1981, visit amount to nearly $250. Charges submitted for these tests reported on the SMAC-22 (Exhibit 7) amount to $187. Respondent testified she paid for the SMAC-22 tests she ordered and did not bill the insurance company for these tests because "they won't pay for both" SMAC and manual tests performed on the same sample. Since the lab charged Respondent only $10-$12 for the SMAC-22 tests conducted, the insurance company would not pay $187 if these tests were charged as automated tests. Considerable evidence was submitted that there was no medical justification for certain of the tests performed on Nancy, Elsa, and Jose Trujillo. For Nancy, these unnecessary tests included tests for calcium, glucose, BUN, creatinine, albumin, bilirubin, total protein, and SGPT. For Elsa, these unnecessary tests were calcium, phosphorus, uric acid, total protein, bilirubin, with either BUN or creatinine justified, but not both. For Jose, no medical justification was shown for manually performed tests for glucose, calcium, phosphorus, electrolytes, SGDT and SGNT. In view of the finding above, that these tests were not manually done but were performed as a SMAC-22, the fact that they are not medically justified if done manually becomes immaterial.
The Issue Whether Respondent acted contrary to its governing statutes, rules, policies, or project specifications in selecting the winning response to the subject Request for Proposals and, if so, whether any such act was clearly erroneous, arbitrary, capricious, or contrary to competition within the meaning of Section 120.57(3)(f), Florida Statutes.
Findings Of Fact At all times material to this proceeding, Respondent was a duly-constituted School Board with the duty to operate, control, and supervise all free public schools within the School District of Miami-Dade County, Florida, pursuant to Article IX, Florida Constitution, and Section 230.03, Florida Statutes. For over 25 years Respondent has used school facilities to conduct blood collection drives from students over the age of 17 years and adults. Intervenor conducted the blood drives for Respondent in the past and, at the time of the RFP at issue in this proceeding, was the incumbent provider. The only previous request for proposal (the 1998 RFP) issued by Respondent for the blood collection drive occurred in 1998. Petitioner and Intervenor were the only two entities submitting responses to the 1998 RFP. Intervenor was selected as the winning proposer in 1998. At times pertinent to this proceeding, Elda Martinez was Respondent's Coordinator of Special Projects for the Bureau of Community Services, Linda Brown was the supervisor for Ms. Martinez, and Alex Bromir was the supervisor for Ms. Brown. Ms. Martinez, under the supervision of Ms. Brown and Mr. Bromir, had the primary responsibility of preparing the 1998 RFP and the RFP. Barbara Jones, Director of Procurement Management and Material Testing for Respondent, assisted Ms. Martinez in the preparation of the RFP. On May 21, 2001, Respondent mailed the RFP to potential proposers to solicit proposals for the administration of its blood collection drive program. Respondent received timely responses to the RFP from Petitioner and from Intervenor. No timely protest to the RFP specifications was filed.2 Article II of the RFP provides that the purpose of the RFP is ". . . to designate one blood center to collect blood donations from students and staff at Miami-Dade County Public Schools [sic] facilities." Article IV of the RFP provides general information about the school district and a general description of the blood collection drive program. Article IV(K) provides that the blood center must have donor and individual school recognition programs acceptable to Respondent. Article IV(L) provides that a scholarship incentive program through the College Assistance Program (CAP) is desirable. Article V of the RFP sets forth certain technical requirements. Responders to the RFP were required by Article V(A) to provide the following documentation and information: Documentation of its status as a not- for-profit organization. The last two years of audited financial records. The blood center must agree to complete and open access by appropriate Miami-Dade School Board representatives and by the media, to the details of these financial records, if requested. The past three years of the Federal Drug Administration (FDA) and the American Association of Blood Banks (AABB) inspection reports, including 483 forms, warning letters, or intent to revoke license correspondence with the FDA. * * * Documentation that the blood center is active in the educational efforts of the school system they serve. (i.e., provide educational programs for teachers, staff, and students) [sic] Documentation that the blood center can develop, implement, and actually execute a school-based scholarship program within a school district at no cost to the school district. Description of existing programs in the school districts currently served. . . . Article V(B) is as follows: The organization shall provide an adequate number of mobile units, personnel, materials, equipment, and supervision to carry out the estimated number of blood units to be collected in the blood drive. Article V(C) is as follows: The blood center must provide sufficient trained and skilled personnel to screen the donors to insure that they will not be placed at risk by donating blood. Article VII of the RFP, which pertains to evaluation of proposals, provides as follows: Proposals will be evaluated by representatives of the school district in order to ascertain which proposal best meets the needs of the School Board. The Selection Committee will consist of the following or their designees: -Chief Administrator, Bureau of Community Services -Executive Director, Community Participation -Representative from Risk and Benefits - Management and Services -Principal, Senior High -Principal, Adult Center -Coordinator of Special Projects, Bureau of Community Services -A school based Activities Director -A representative from PTSA Council -A representative from Student Services -A representative from the Student Government -A representative from Comprehensive Health/Health Education -A representative from the Division of Business Development and Assistance -A representative from the Division of Procurement Management and Materials Testing Evaluation considerations will include but not [be] limited to the following: Responsiveness of the proposal clearly stating an understanding of the work to be performed meeting all guidelines. Documentation of present certification; qualification of laboratory staff members; past experience and record of performance; verification of references. Primary emphasis in the selection process will be placed on the background, experience, and service of staff to be assigned to the project. Expertise in the areas addressed in the RFP, and the ability to respond in a timely, accurate manner to the district's requirements is essential. An important consideration is the methodology of blood collection which takes into consideration not only expediency but the safest and least painful procedures. The blood center must demonstrate commitment to the continuing education of the students and faculty. The generosity of the scholarship program to be distributed by the College Assistance Program (CAP) will be another factor to be taken into account. The availability of sufficient mobile units to cover all high schools, adult centers, and vocational/technical schools so that all the students have an equal opportunity to participate in the program. The school district reserves the right to reject any and all proposals submitted. When the final selection is made, a contract acceptable to the Attorney of the Board [sic] will be entered into with the successful proposer. No debriefing or discussions will be held with unsuccessful vendors. Proposals from Petitioner and Intervenor were opened on June 14, 2001. On June 18, 2001, a Selection Committee, formed in accordance with the requirements of the RFP, met to evaluate the proposals. There was no issue at the First Meeting as to whether both proposals had satisfied the technical specifications of the RFP. At the beginning of the First Meeting the Selection Committee members were given an agenda of the meeting, a chart comparing the scholarship programs being offered by the two proposals (the chart), and evaluations of the Intervenor's performance as the present provider. There were 14 members of the Selection Committee. Mr. Bromir was the chairman and a voting member of the First Meeting. Ms. Martinez and Ms. Brown were also voting members of the Selection Committee. Ms. Martinez had worked with Intervenor's staff for several years and thought they did a good job directing the blood drive. She believed that Intervenor's contract with Respondent (as a result of the 1998 RFP) should have been renewed without the necessity of a new RFP. Intervenor honored Ms. Martinez, who was about to retire, at an awards luncheon shortly before the First Meeting. Ms. Martinez clearly favored Intervenor throughout the selection process and greeted representatives of Intervenor with embraces prior to the start of the First Meeting. Both proposals responded to the evaluation criteria set forth in Article VII(F) pertaining to the generosity of the scholarship program. Ms. Martinez prepared the chart that was distributed at the beginning of the meeting. The chart purported to compare the two scholarship proposals and was the focus of considerable attention at the final hearing. The evaluation included a determination as to what could not be included in Petitioner's proposal and estimates as to what would likely be included in Intervenor's proposal. Petitioner's response to the RFP committed to contribute $225,000 in direct donations to the CAP. In addition, the response reflected that participating schools would earn a minimum of $217,000 in recognition payments during the contract's initial, three-year term. A direct donation to participating schools is prohibited by School Board rule, and, consequently, a participating school could not earn such a donation. However, the RFP contained the following savings clause: "Any surplus funds not earned, as part of this guaranteed minimum funding to participating schools, will become an added donation to the College Assistance Program (CAP)." Because of the savings clause, Ms. Martinez correctly determined that the minimum guarantee to the CAP over the initial three- year term was $442,000 ($225,000 + $217,000). In addition to the foregoing, Petitioner's proposal contains a bonus program that could be earned by participating schools. Because these are the type payments that are prohibited (and were not requested by the RFP) and because there was no savings clause pertaining to these funds, Ms. Martinez correctly determined that the bonus program could not be considered in evaluating Petitioner's proposal. The printed agenda for the First Meeting, prepared by Ms. Martinez, included the following item: Before starting the discussion, explain that the RFP did not request for [sic] direct donations to the schools and that therefore the monies earmarked for this purpose will not be considered (as part of a scholarship or incentive program). However, since the agency (Petitioner) that offered it (direct donations to the schools) had a clause whereby "surplus funds that are not earned from the guaranteed minimum funding will become an added donation to the CAP", the minimum funding may be added to the CAP guaranteed donation. However, the bonus program should not be considered. Ms. Martinez spent considerable time in preparing the chart and attempted to present a fair comparison between the two proposals. Unfortunately, Ms. Martinez was required to make certain assumptions as to Intervenor's proposal because it contained a bonus plan that depended on the success of future blood drives. The Intervenor's bonus plans, which neither contains a minimum nor a maximum, required Ms. Martinez to estimate the success of future blood drives.3 Ms. Martinez' chart set forth that Intervenor's guaranteed scholarship contribution over the initial three-year term would be $124,800 and the estimated contribution from bonuses during that period would be $325,145.00, so that the total scholarship contribution would equal $449,945.00 for the initial three-year term (compared with $442,000.00 for Petitioner). The evidence presented at the final hearing failed to establish that her estimates were reliable. Because of her estimates, Ms. Martinez' chart did not provide an accurate comparison of the two proposals. In weighing the impact of the misleading chart, the undersigned has considered Ms. Martinez' leadership role in securing the procurement, the absence of specific evaluation criteria in the RFP, and the lack of instruction as to how the Selection Committee was to evaluate the scholarship proposals. Those considerations establish that the misleading chart was not a de minimis error. Prior to the decision to issue the RFP, Ms. Martinez attempted to evaluate Intervenor's performance as the provider pursuant to the 1998 RFP. She solicited evaluations from personnel at the various schools at which blood drives had been conducted. In addition to distributing the misleading chart, Ms. Martinez distributed to the Selection Committee at the First Meeting summaries of the positive evaluations of Intervenor that she had solicited from school personnel and added her own positive comments as to Intervenor's performance. Further, Ms. Martinez asked other persons on the Committee to attest to their own good experiences with Intervenor. The testimonials on behalf of Intervenor came from a nurse instructor, an activities director, principals, a student, and a PTA representative. The testimonials made the following points: Intervenor stresses education; Intervenor encourages student-run blood drives; blood unit giving greatly increased during Intervenor's contract; there was excellent cooperation from all of Intervenor's staff; and the program runs smoothly in schools. Ms. Martinez' acts of distributing the positive evaluation summaries and of soliciting testimonials on behalf of Intervenor tainted the Selection Committee's evaluation process at the First Meeting because it moved the focus of the evaluation from the evaluation criteria set forth in the RFP to the issues of whether the existing provider for the blood drive had been doing a good job and whether there was a need for change. Such acts were contrary to the evaluation criteria set forth in the RFP. Petitioner was not given an equal opportunity to supply positive recommendations from its clients nor was it allowed to have its clients address the Selection Committee to attest to their positive experiences with Petitioner. Intervenor was accorded an unfair competitive advantage by Ms. Martinez' acts of distributing positive evaluation summaries and soliciting testimonials on behalf of Intervenor. In addition to the foregoing, the minutes of the First Meeting reflect that the Selection Committee found the following to be of significance: number of mobile units available (25 for Intervenor and 17 for Petitioner), bad donor letter (attachment 7 to its proposal),4 personnel available (150 for Intervenor and 84 for Petitioner), the scholarships being offered, and the cash and cash equivalents at the end of the year as reflected by the financial statements ($1,800,000 for Intervenor and $26,200 for Petitioner). Article V(B) of the RFP requires the proposer to provide an adequate number of mobile units, personnel, materials, equipment, and supervision to carry out the estimated number of blood units to be collected in each blood drive. The Selection Committee had not determined the number of mobile units and personnel needed to perform the contract. Because that determination had not been made, there was no basis to judge what constituted an adequate number of mobile units and personnel. It was a material error for the Selection Committee to base its decision on the relative number of mobile units and personnel each proposer had available without first determining what constituted an adequate number of mobile units and personnel. It was not error for the Selection Committee to consider attachment 7 to Petitioner's proposal. The referenced material includes negative findings and comments from regulatory authorities following inspections of Petitioner's laboratories. Petitioner's complaint that it had to submit information as to its in-house laboratories while Intervenor did not have to submit similar information as to the independent laboratories it used is a collateral attack on the specifications of the RFP that is rejected as being untimely and without merit. The RFP required each proposer to submit audited financial statements as part of its response. Petitioner's assertion that it was error for the Selection Committee to consider the relative financial strengths of the two proposers is without merit. At the First Meeting the committee voted 14 to 0 in favor of awarding the contract to Intervenor. Thereafter Petitioner timely filed a challenge to the proposed award and the matter was referred to DOAH for formal proceedings and assigned DOAH Case No. 01-3047BID. Prior to a formal hearing before an Administrative Law Judge, Petitioner and Respondent filed a Joint Motion for Withdrawal of Petition and Dismissal Without Prejudice on the grounds that the proceeding was not ripe for hearing because the five-day public notice requirement for the First Meeting was not observed. Pursuant to the Joint Motion, DOAH Case No. 01-3047BID was closed and jurisdiction of the matter was relinquished to Respondent for further proceedings. Thereafter, Respondent invalidated the actions taken at the First Meeting and scheduled the Second Meeting. Mr. Bromir and Ms. Martinez retired between the First Meeting and the Second Meeting, which occurred August 29, 2001. Ms. Brown chaired the Second Meeting, which consisted of 11 voting members. Eight of the 11 voting members at the Second Meeting had participated as voting members at the First Meeting. No new instructions were given the members at the Second Meeting, other than they were to disregard the actions of the First Meeting. No financial analysis of the two proposals was distributed or discussed at the Second Meeting. Accordingly, the only analysis any of the committee considered or discussed regarding a comparison of the financial benefits offered by the two proposals was the misleading chart prepared by Ms. Martinez. In addition, no instructions were given at the Second Meeting to ensure that members who were present at the First Meeting would not be improperly swayed by the positive evaluations and testimonials presented on behalf of Intervenor. It is clear that the Selection Committee at both the First Meeting and the Second Meeting selected Intervenor in large part because it was doing a good job as the incumbent provider. The eight members of the Selection Committee who had been at the First Meeting and improperly selected Intervenor based in part on its incumbency were not advised that they could not make their selection on that improper basis. The failure of Respondent to cure the defects of the First Meeting tainted the Second Meeting. The minutes of the Second Meeting contain an incorrect fact that was a factor in the Selection Committee's evaluation of the two proposals. The minutes reflect that Petitioner had only two mobile units available to serve the school system. That reference is clearly an error because Petitioner's proposal represents that it had 17 mobile units available. According to the minutes, the number of available mobile units was a factor favoring the selection of Intervenor.5 Consequently, the reference to the two mobile units is a material error that tainted the Second Meeting. At the Second Meeting, Ms. Jones, a non-voting staff member who assisted in conducting the meeting, raised the issue as to whether Petitioner's proposal was unresponsive to one of the technical criteria, namely, the requirement of presenting “documentation” of its educational efforts in the school systems in which it serves. There was no determination by the Selection Committee that Petitioner was not a responsive proposer, and there was no evidence that Ms. Jones raised that issue for improper motives. Since the actions of the First Meeting had been invalidated, the issue as to whether the proposals met the technical criteria was an appropriate issue for the Second Meeting. Petitioner's argument to the contrary is rejected. Respondent's procurement rules require that minutes be kept of each Selection Committee meeting and that the minutes document the reasons for the recommendation coming out of the meeting. The minutes kept for the First Meeting and the Second Meeting do not accurately reflect what was discussed. For example, according to Ms. Jones, there was a discussion of the relative financial terms being offered by the proposals at the First Meeting. No such discussion is reflected in the minutes of that meeting. Additionally, there was limited discussion about financial benefits at the Second Meeting, yet minutes of the Second Meeting do not reflect that the Committee discussed or considered the relative financial merits of each proposal. There was no other written statement by either the First or Second Selection Committee of the reasons for its decisions. Intervenor represented that it and the labs it use are considered by the Food and Drug Administration to be among the best in the United States. That statement is at most a minor, waivable defect that should be considered puffery. The statement is not a material misrepresentation. Intervenor represented in its response that it was the only blood bank in South Florida that had the endorsement of the Red Cross. That statement is at most a minor, waivable defect that should be considered puffery. The statement is not a material misrepresentation.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Miami-Dade County School Board invalidate the award of the contract to Intervenor and conduct a new selection process. DONE AND ENTERED this 14th day of August, 2002, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 14th day of August, 2002.
Findings Of Fact Southwest Florida Blood Bank, Inc., is a nonprofit community blood bank operating principally in the Tampa Bay Area. It operates a number of facilities known as "transfusion services" in hospitals in the Tampa Bay Area. It has paid separate licensure fees for three of these facilities. Leon County Blood Bank, Inc., is a nonprofit community blood bank operating in Leon County, Florida. It operates several facilities known as "transfusion services" within the County. It has been required to pay separate licensure fees for one of these facilities. No evidence was presented as to Petitioner Jacksonville Blood Bank, Inc. No evidence was presented as to Petitioner Florida Association of Blood Banks, Inc., although the parties did stipulate that it is a trade group which develops professional standards. "Blood banking" is an activity which involves administrative and medical functions in making available for transfusion to patients human blood and blood components. The operational procedures of a blood bank typically involve recruiting activities to attract volunteer donors. These donors are screened, questioned, and evaluated for suitability. If suitable, a blood donation is voluntarily obtained. Screening and collection procedures involve performance of a hematocrit, hemoglobin and blood typing. These procedures are clinical laboratory procedures subject to regulation under Chapter 483, Florida Statutes. They provide information about the health of the prospective donor and the suitability of blood for ultimate transfusion. Blood is typically collected at either the principal blood bank facility or at remote collection stations sometimes referred to as branch offices or mobile donor units. Blood is infrequently collected at facilities known as transfusion services. Once the blood is collected, it is processed using a variety of test procedures including antibody screens, serologic tests, and other procedures to determine the suitability of blood for storage prior to a need for ultimate transfusion. Human blood can be and is frequently separated into various blood components. Separation into components can occur before or after various test procedures are performed. Once the blood or components have been completely processed, the label is identified as to blood type and immunohematologic properties. The blood is then stored until it is needed for transfusion. All of these procedures typically occur in the principal blood bank facilities and are referred to as processing. Before blood can be transfused to a patient, further procedures must be performed. When a physician orders blood or a blood component for transfusion to a patient, a sample must first be obtained from the intended patient/recipient. The patient's sample is then mixed with a sample of blood or blood component obtained by donation in order to test compatibility. This procedure is known as a crossmatch. If the blood is determined to be compatible, then it is provided to the hospital for transfusion to the patient/recipient. The hospital will then either transfuse the blood or store it awaiting transfusion. Crossmatch procedures are often performed in the principal blood bank facility. However, they are also performed in facilities known as "transfusion services" located in hospitals. These facilities are operated both by hospitals and blood banks. Blood collection is usually performed in the principal blood bank, a collection station branch office or a mobile donor unit. Processing is typically done at a central location. Blood banks frequently rent or lease space in hospitals in which they operate facilities referred to as "transfusion services." These facilities have the capacity to store limited amounts of blood and to perform crossmatch procedures when blood or a blood component is requested for transfusion to a patient/recipient. A "collection station" is a remote location in which the only activity is the collection of blood from donors. The Southwest Florida Blood Bank (hereinafter "SWFBB") operates multiple locations in which it collects blood. It also operates four mobile donor units. The SWFBB performs the majority of its procedures at its principal location near the University of South Florida. This facility is licensed by the Department and a licensure fee is paid. SWFBB leases or rents space in hospitals at Tampa General Hospital, St. Joseph's Hospital, Humana-Brandon Hospital and a new facility known as Women's Hospital. It performs crossmatch procedures at each of these locations. The Department has required separate licensure and payment of a separate fee for each facility. SWFBB also provides blood and blood components to a number of hospitals in which the hospital performs the crossmatching. The Leon County Blood Bank (hereinafter "LCBB") performs crossmatch and compatibility testing at its principal location for blood supplied to hospitals. LCBB also leases or rents space at Tallahassee Memorial Hospital and Tallahassee Community Hospital where it provides personnel to perform crossmatch and compatibility testing procedures within the hospital. The Department requires separate licenses and payment of separate fees for facilities located at Leon County Blood Bank and Tallahassee Community Hospital. (It does not charge a separate fee for the facility located within Tallahassee Memorial Hospital because LCBB is located on property adjacent to the hospital, but it does require separate licensure.) The LCBB also provides blood to hospitals in nearby counties where the hospital operates a transfusion service to perform the crossmatch. The Department has defined the activities which it considers to be a "transfusion service." They include the performance of therapeutic pheresis; preparation of red blood cells; recovery of human plasma; and collection of blood. According to the Department, these activities do not require licensure. However, activities involving crossmatching, prenatal immunohematology procedures or other procedures for therapeutic administration of blood or blood components are considered to be clinical laboratory procedures and require a separate license. Hence, they are not activities of a "transfusion service" according to the Department. The separation of activity the Department has established fails to comport with any breakdown recognized or applied in the medical, blood bank or hospital industry. All witnesses who testified indicated that a "transfusion service" has always included the activity of crossmatching or compatibility testing of blood. Dr. Paul Schmidt, a preeminent national authority in blood banking with over thirty years experience, testified "transfusion service" has always included the activity of crossmatching. This was confirmed by Dr. Malloy who has been involved in both national and state blood banking for over twenty years. Their understanding is further confirmed by the Department's own witness, Laura Phillips, who was responsible for promulgation of the challenged rule. No witness who testified could identify a single instance in which a "transfusion service" operates in the manner of the activities broken down by the Department in its rule under challenge in this cause. The Department's exclusion of crossmatching procedures from the definition of "transfusion service" contradicts the historical meaning of the term and the functional breakdown of activities which exist and have always existed in the industry. Dr. Schmidt and Dr. Malloy testified without contradiction that a transfusion service does not collect blood. Furthermore, neither is aware of any transfusion service which has ever been involved in continuous blood collection. The Department offered no evidence of a facility which engages in such activity. Both Dr. Schmidt and Dr. Malloy admitted that preparation of red blood cells and recovery of human plasma could be done in a transfusion service, but that these activities as a matter of practice were generally done in a blood collection and processing facility. Neither is aware of any entity or facility which has performed the various functions which the Department attributes to a transfusion service in their rule. The Department has never attempted to ascertain whether facilities exist which meet the definition contained within their rule. The only facilities which the Department could identify as meeting their definition were "collection stations or mobile units." Finally, the testimony is uncontradicted that crossmatching is inherently a function of a "transfusion service." Authoritative medical and industry standards as well as state and federal regulations uniformly include the function of crossmatching within the activities performed by a "transfusion service." The American Association of Blood Banks Standards, which are the most comprehensive recognized standards existing within the United States and perhaps the world, define and refer to a transfusion service as including the functions of "storing, crossmatching and issuing blood for transfusion." These standards are applied by organizations such as the Joint Commission on Accreditation of Hospitals and the College of American Pathologists in defining hospital practice and inspection procedures. The Department itself uses these standards. It has entered into an agreement for alternate-year inspections of blood banks and transfusion services with the AABB which adopts the AABB standards and guidelines, including the definition of a "transfusion service." The federal Health Care Financing Administration has adopted a definition for "transfusion services" which includes the crossmatching and compatibility testing of blood. The federal Food and Drug Administration also defines transfusion service as involving compatibility testing. More importantly, the Department has been delegated inspection responsibilities under federal regulations and pursuant to federal regulations in determining qualifications for Medicare reimbursement certification. Finally, the Department's own survey reports contain reference to "transfusion service" in the context of procedures which include activities involving crossmatching and compatibility testing. The Department acknowledges that its rule definition of "transfusion service" is inconsistent with federal regulations as well as their own practices and procedures. The Department justifies its rule distinction between those activities which are referred to as a "transfusion service" and those activities which are not and require licensure and payment of a separate fee, by claiming that certain activities performed by "transfusion services" are not "clinical laboratory procedures". However, even this explanation is contradicted by the evidence. The testimony is uncontradicted that collection of blood involves performance of procedures known as hemotocrit, hemoglobin and blood typing. These procedures are acknowledged to be clinical laboratory procedures. Hence, under the Department's own analysis, a "transfusion service" performing collection of blood would be a clinical laboratory and thus fail the Department's rule definition. The Department has required payment by SWFBB and LCBB of licensure fees for facilities which each leases or rents at hospitals where the principal activity is the crossmatching and storing of blood of transfusion. The most recent separate fee charge for each of these facilities is $750.00 per year per facility. The Department is not able to cite any authority, standard or state or federal regulation consistent with its definition of transfusion service. It is unable to identify any facility which has met, or in the future would meet, its definition. Petitioners have stipulated that transfusion services are a kind of clinical laboratory and are thus subject to separate licensure as a clinical laboratory.
Findings Of Fact The findings of fact set forth in the Recommended Order are approved and adopted and incorporated herein. There is competent substantial evidence to support the findings of fact.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 18th day of August, 1988. WILLIAM J. KENDRICK 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 18th day of August, 1988.
Findings Of Fact The Respondent is a licensed medical doctor holding license number 0013446 issued by the Florida Board of Medical Examiners. He specializes in internal medicine, geriatrics, endocrinology and nuclear medicine with an extensive educational and professional background in those fields. He is currently in private practice in Dade County, Florida. The Petitioner is an agency of the State of Florida charged by Chapter 458, Florida Statutes (1981), with administering, regulating, and enforcing the licensure and medical practice standards as delineated by that chapter and related rules. Maurice Blanchar was examined at the Miami Heart Institute in 1976. At that time it was suggested by his attending physician that Mr. Blanchar have a "nuclear scan" because of a suspected abnormality described as "Gallin Syndrome." Mr. Blanchar was also examined at the Cooper Clinic in Dallas, Texas, in 1979, at which time it was also suggested that he have a nuclear scan (apparently related to cardiac complaints at that time of an unspecified nature). A coronary angiogram was performed at the Cooper Clinic, which was within normal limits. Sometime in 1979, Mr. Blanchar, with a prior history of undiagnosed cardiac complaints, read an advertisement in a local newspaper which offered nuclear scans to be performed by the Respondent, Dr. Sternberg. Mr. Blanchar kept this advertisement in his possession for approximately one year and ultimately called the Respondent's office for an appointment in July of 1980. Upon obtaining his appointment, Mr. Blanchar was advised to bring $95 as a initial fee, together with proof of medical insurance coverage. Upon arriving for his scheduled appointment at the Respondent's office, Mr. Blanchar executed a questionnaire designed to disclose his medical history. His specific presenting complaint was that he was suffering chest pains. He was a regular "jogger" and had no pain or discomfort attendant to this exercise, but suffered chest pains only while resting in bed at night. He met with the Respondent and informed the Respondent that he was responding to the advertisement regarding "nuclear scans" and informed the Respondent of his complaint, a somewhat unusual occurrence. Based upon Mr. Blanchar's complaints, together with information discerned from Mr. Blanchar's previous records from the Cooper Clinic and the Miami Heart Institute, Dr. Sternberg discussed the procedures he intended to perform with Mr. Blanchar. Dr. Sternberg informed him of the tests he would perform before and as he was performing them. Dr. Sternberg explained, and Mr. Blanchar admitted in his testimony, that the $95 fee was not for the entire nuclear scan series of tests performed, but was rather for a consultation and initial examination performed by the Respondent. The record does not clearly reflect whether specific fees for tests or procedures to be performed were discussed between the Respondent and Mr. Blanchar at this time, other than the Respondent informing Mr. Blanchar that his insurance company would pay for the cost of the nuclear scans involved. Prior to beginning the testing, the Respondent had no presupposition that Mr. Blanchar had cardiac arterial disease, based upon a previous normal coronary angiogram, and the symptoms of lack of pain while jogging, but pain while at rest in bed at night. Dr. Sternberg was aware that Mr. Blanchar was a jogger, which indicated to the Respondent that in terms of likelihood, his chances of having coronary artery disease were extremely small in terms of percentages. However, the fact that he developed chest pains while at rest in bed, led Dr. Sternberg to believe that this symptom could possibly be related to coronary artery disease. Because of the possibility of a hiatal hernia, arthritis, or possibly a congenital heart lesion, the Respondent performed three tests, the so-called "first pass," "MUGA at rest" and "MUGA at stress." All tests were designed to give complementary information, which information is not necessarily achievable by any one procedure in and of itself. The first procedure performed was the cardiac imaging blood pool test, commonly referred to as a "first pass study." It is the function of this test to assess the pattern of blood flow through the heart to determine right and left ventricular performance which is measured by cardiac wall motion and "ejection fraction." The first pass test is also utilized if there is a suspicion of vascular misformation, obstruction or shunting in a patient's heart. The first pass test was found to yield results within normal limits. The next procedure performed by the Respondent was the cardiac imaging, gated, static test, designed to show cardiac wall motion and ejection fraction, which last term is related to the volume of blood pumped by the heart upon ventricular contraction. This procedure is commonly termed the "MUGA at rest" study. The main concern of this test is a measurement of cardiac function as observed by wall motion of the heart and measured by the ejection fraction while the patient is at rest. This procedure is most commonly done as a baseline study for obtaining information concerning cardiac function while the patient is at rest for purposes of comparison with the cardiac imaging, gated, wall motion, ejection fraction test done with the patient at stress. This latter test is referred to as "MUGA at stress" and is performed in the case of patient Blanchar by using the so-called "Cold Presser Method," which involves stressing the heart to the required degree for the test by fastening an ice bag on the arm of the patient until he has reached the level of stress desirable for performing the MUGA at stress test. The MUGA at stress performed by the Cold Presser Method, although somewhat experimental, is an accepted means of inducing cardiac stress in the patient for purposes of obtaining meaningful MUGA at stress results. The MUGA at stress test, when used in conjunction with the MUGA at rest study, gives the physician a comparison of relevant data concerning cardiac function. Dr. Sternberg was the primary treating physician for Mr. Blanchar. He did not see him on a referral basis from any other physician with any attendant request to do a specific or narrow diagnostic service. Rather, Mr. Blanchar presented himself with a complaint of chest pains at night while at rest, therefore Dr. Sternberg had a broader range of potential problems to consider in determining which diagnostic test to perform on Mr. Blanchar. When Dr. Sternberg performed the first pass test, which was performed first of the three tests performed on patient Blanchar, the ejection fraction was normal, but on the lower side of a normal range for this patient. Dr. Sternberg and the Respondent's expert witness, Dr. Epstein, as well as Dr. Gottlieb testifying for the Petitioner, established that the first pass test is medically indicated to rule out problems such as "shunting," obstructions or regurgitation. Dr. Sternberg had no prior medical history of Mr. Blanchar which would automatically rule out any such problems and, in the exercise of sound medical judgment, felt that the first pass test should he performed. The decision to perform this test was medically appropriate given the patient's symptoms and the doctor's responsibility as the only primary care physician involved. Dr. Sternberg then performed the MUGA studies at rest and at stress and found that the wall motion of the heart looked normal in the left anterior oblique view. The ejection fraction was normal with the MUGA study "at rest" test, but was higher in the normal range than had been the case with the first pass study, which led him to believe that the previous first pass study had an anxiety factor in the patient as a contributing factor to its results. Thus, the MUGA at stress test was able to confirm the efficacy of the performance of and results of the first pass study and Dr. Sternberg was, as well, able to rule out any problems related to shunting, regurgitation, or obstruction in the patient. He was able to confirm that the first pass study, with the patient's anxiety as a factor, had resulted in a slightly altered ejection fraction result. In any event, after these two tests were performed, he also felt the need to look at the wall motion of the heart, under stress conditions in the other areas of the heart, because he had not yet found any area of abnormality. Ultimately, no substantial abnormality was found in the patient's heart, except a suggestion that stress altered his ejection fraction. He also found that the wall motion of Mr. Blanchar's heart in the region of the left circumflex branch, the posterior laterial wall, towards the apex, showed sluggish motion, in fact, almost a paradoxical type of motion during stress, as compared with the baseline study which indicated that there was evidence of probable coronary artery disease at that point. Dr. David Allen Epstein practices diagnostic radiology and nuclear medicine. He was accepted as an expert witness on behalf of the Respondent and largely corroborated the Respondent's testimony, finding the procedures performed by Dr. Sternberg for patient Blanchar to be medically legitimate and to constitute matters of clinical judgment. Dr. Epstein established that the Respondent had available to him other justifiable tests beyond those he performed for Mr. Blanchar and established that the first pass, MUGA at rest and MUGA at stress studies performed, were for medically justifiable reasons and, in a patient with the presenting symptoms of Mr. Blanchar, were each designed to elicit information not directly available from the other tests. The use of color for cardiac computer studies is a useful diagnostic procedure. Neither Dr. Stuart Gottlieb nor Dr. Stolzenberg (Petitioner's expert witnesses) found any fault with the management or care provided these patients, nor the choice of tests performed by Dr. Sternberg with the exception of the first pass test and the separately billed stress test. Both Drs. Gottlieb and Stolzenberg felt the first pass test was redundant. However, their testimony in this regard is rejected and Dr. Epstein's and the Respondent's is accepted, inasmuch as the Respondent was the primary care physician and the only physician concerned with these proceedings who saw the patients in a clinical setting, charged with evaluating the patient's own complaints and arriving at a diagnosis. Patient Blanchar was not presented to the Respondent by another referring physician upon a narrow area of specific inquiry, rather Dr. Sternberg had to perform the added first pass study in order to rule out possible shunting, obstruction, regurgitation and other problems and his testimony regarding the necessity for this is corroborated by that of his expert, Dr. Epstein. It was established that all three cardiac studies were efficacious with regard to patient Blanchar and the Respondent's testimony and Dr. Epstein's testimony is accepted to the exclusion of other testimony in this regard. The Respondent's bill presented to patient Blanchar (and presumably his insurance carrier) is set forth in Petitioner's Exhibit "A" and reflects the following charges: Comprehensive office visit, new patient $ 95.00 Stress testing 150.00 Provision of Radionuclide 20.00 Cardiac Imaging gated (wall Motion, ejection fraction) w/stress 500.00 Cardiac Imaging gated (wall Motion, ejection fraction) static 500.00 Cardiac Imaging blood pool (1st pass) and or vascular flow 500.00 Dr. Sternberg charged patient Blanchar an additional $150 for "stress testing" which is represented on his bill to be a separate and different test from the cardiac imaging, gated, wall motion study with stress or "MUGA at stress," for which the doctor charged Blanchar $500. Although the Respondent represented that this "stress testing" was a separate service performed, there is no evidence whatever in the record which would establish that such a stress test was performed separate and apart from the MUGA at stress, performed for the $500 charge. A separate stress test would have been redundant and unnecessary in any event. It is obvious therefore that the patient Blanchar was billed for a separate item called "stress testing" in the amount of $150 which was not actually performed and which was not necessary. Dehlia Teramo suffered an automobile accident on March 12, 1980. She was initially seen by Dr. Carlos B. Fernandez, who saw her on the day of the accident. He ultimately referred Ms. Teramo to the Respondent with a history of trauma sustained in the accident with subsequent pain throughout her head, ears, eyes, neck, nose, and left shoulder. On April 10, 1980, Ms. Teramo initially saw the Respondent complaining of frequent headaches, neck pain, eye pain, high blood pressure, back and shoulder pains and pain in her nose, having sustained trauma and unconsciousness after being thrown about in the interior of her car during the auto accident. She additionally suffered pain in the left upper and lower parts of her mouth and suffered a recurrence of her menstrual period. Dr. Fernandez sent her to the Respondent for evaluation and diagnosis with reference to all these physical complaints, including the possibility of a fracture in the head or left shoulder area, but not solely for determination of the presence of a fracture of the sphenoid bone of the head. The Respondent performed three diagnostic tests or studies on different dates to attempt to determine the basis of Ms. Teramo's injuries. The first study was conducted on April 10, a blood circulation study. This study, when confined to the cerebral area is known also as a brain flow study. The study was conducted by the Respondent in area of the head as well as the spine and shoulder. The test is performed by injecting the patient with a radionuclide and then following the "bolus" throughout the areas in the which the physician is interested in gathering data with an x-ray camera assisted by a computer. In effect, this test images the blood flow in the blood vessels involved in the head, spine and shoulder areas and is used to detect subdural or epidural hematomas, abnormal vascular changes in the brain and in the other areas tested. It is designed to show any breaks or "leaks" in the blood/brain barrier, that is, any passage of blood from the vascular system of the brain into surrounding brain tissue. In itself, it is not the primary test for determining a fracture, but it is useful and all expert witnesses agreed and established that it was within sound medical judgment and patient management to perform such a test to aid and ascertain the basis for the complaints Ms. Teramo had regarding her head, neck and shoulder areas. A sphenoid bone fracture would be difficult to diagnose with this one test alone, but that was not the sole basis for the referral of Ms. Teramo to the Respondent. The radionuclide which is injected travels throughout the patient's body and the physician can do a number of limited scans or a total body scan utilizing the one injection of radionuclide. In performing the blood circulation or blood flow study, the Respondent charged patient Teramo for each component of the study, in effect, each view taken was charged for as a separate procedure as was the injection of the radionuclide. The computer processing and color image analysis was also disclosed to patient Teramo to be a separate procedure and was billed for separately, as shown on Petitioner's Exhibit "K," the bill set forth below. The blood circulation study and the quantitative cerebral blood flow study were represented to the patient Teramo on the bill as being separate studies and a separate $200 charge was assessed against the patient for the quantitative cerebral flow study. These studies are performed during the same patient visit and utilizing the same injection of radionuclide. The cerebral blood flow study is dynamic, with imaging done as the radioactive "bolus" moves through the vascular area in question. The blood circulation study, also called blood pool study, is the static form phase of the procedure performed after the vascular system in the area in question has already been completely infused with radionuclide. The testimony of Dr. Stolzenberg, coupled with that of the Respondent himself, establishes that the quantitative cerebral blood flow study is indeed tested with the same injection of radionuclide at the same patient visit. It is a different test or procedure, however, although many practitioners do not use it and it is unusual to see it used. However, it was not demonstrated, because it is not a standard type of procedure, that a practitioner should not charge a separate fee for it, not that the brain flow study always necessarily includes a quantitative, cerebral blood flow study. Thus it was not shown that the quantitative, cerebral blood flow study with the separate charge of $200 on Ms. Teramo's bill was not a separately identifiable test performed on her. The Petitioner also was unable to establish that this particular test was not medically indicated for a patient with Ms. Teramo's presenting symptoms. On April 14, 1980, the Respondent performed another nuclear scan on patient Teramo, known as a bone scan. This is accomplished by again injecting the patient with a radionuclide substance which adheres to the bones and joints after passage of a period of time while the patient waits in the examining facility. This scan was utilized for the same areas as the previous scan or blood flow study, that is the head and left shoulder areas and cervical spine area. The bone scan is used to aid in the physician's determination of the presence of fractures. The Respondent separated his charges for this procedure into a separate charge for each view obtained, as well as a separate charge for the injection of the radionuclide, and a separate charge for computer processing and clinical color imaging analysis done by the Respondent himself. On April 18, 1980, the Respondent performed an echoencephalogram upon patient Teramo. This procedure is designed to determine the presence of subdural or epidural hematomas, fractures and tumors. It is commonly utilized in cases of patients who sustain traumatic injury. Having reviewed the results of all these procedures, the Respondent arrived at a diagnosis of patient Teramo as having a fracture of the sphenoid bone of the head. No apparent diagnosis was made with reference to the shoulder area. The Respondent presented a bill to patient Teramo, admitted as Petitioner's Exhibit "K," reflecting the following pertinent charges: 4/10/80 Initial consultation $ 95.00 Injection of Radio- nuclide for scans 20.00 Scans: (Blood circulation study) Head LL 75.00 Head PA 75.00 Head Vertex 75.00 Cervical Spine PA 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head AP 75.00 Head RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis 350.00 Quantitative Cerebral Blood Flow Study 200.00 4/14/80 Office visit 25.00 Injection of Radio- nuclide for scans 20.00 Scans: (Bone and Joint Study) Head AP 75.00 Head RL 75.00 Head LL 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head PA 75.00 Cervical Spine PA 75.00 Cervical Spine LL 75.00 Cervical Spine RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis. 350.00 4/18/80 Office visit 25.00 Echoencephalogram, A-Mode 150.00 The blood and bone scan studies done with regard to Ms. Teramo's complaints, as well as the echoencephalogram, are medically appropriate and a proper exercise of sound medical judgment by a clinical physician and primary treating physician in the position of Dr. Sternberg with regard to this patient. It must be remembered that Ms. Teramo was not merely presented for determining the presence of a sphenoid fracture, rather she was presented to Dr. Sternberg by Dr. Fernandez, for investigation of various types of suspected pathologies. Dr. Sternberg's testimony, as corroborated by that of Dr. Epstein, establishes that certain fractures not always detectable by specific types of radiographic techniques may be detected by the device of blood pool scans. The Respondent showed (corroborated to some extent by Drs. Gottlieb and Stolzenberg) that the tests performed on Ms. Teramo constituted matters of clinical judgment and that Dr. Sternberg had available to him other tests which he could have performed on Ms. Teramo or Mr. Blanchar and did not. Some physicians use color imaging in computer processing and that is a legitimate type of evaluation and diagnostic technique. Further, Dr. Stolzenberg recognizes that there are some physicians who do cerebral blood flow studies of the brain and charge fees there for and acknowledges that there is no prohibition against such a procedure and that some physicians use the aid of a computer during performance and evaluation of brain scans as a routine matter. Neither of the Petitioner's expert witnesses are primary care physicians and Dr. Stolzenberg admitted that he does not practice internal medicine; neither have examined either of Dr. Sternberg's patients concerned in this proceeding. Only Dr. Sternberg, of the three doctors involved, is a primary care physician. It has thus been shown that the first pass study, the MUGA at rest and the MUGA at stress studies, as well as the blood circulation study, quantitative cerebral blood flow study and bone scans performed on these two patients were medically legitimate and all were within an appropriate choice of tests and were selected and performed in a manner within acceptable medical standards. The fact that the Respondent charged a $75 fee for each of the various scans or views of the head, shoulders, and cervical spine of Ms. Teramo for purposes of the blood circulation study and the bone scans performed appears exorbitant, however there is no evidence that it was not a charge directly related to the Respondent's time and skill as a highly trained specialist, coupled with a component in each of those charges for the use of highly sophisticated, color, computer processing equipment and camera which he owned and operated himself in his own office. Since the specific rates charged by physicians for this and any other type of service, are not regulated, these charges cannot be delved into further for purposes of this proceeding once the diagnostic procedures to which they relate have been established, to be medically acceptable, which they have, with the exception of the $150 charged patient Blanchar for the unperformed stress test.
Recommendation Having considered the foregoing Finding of Fact, Conclusions of Law, the candor and demeanor of the witnesses and the pleading and arguments of the parties, it is, therefore RECOMMENDED: That the Board of Medical Examiners enter a Final Order finding the Respondent, Joshua L. Sternberg, M.D., guilty of a violation of Sections 458.331 (1)(1) and (o) Florida Statutes (1981), to the extent delineated above, and that he be fined the sum of $1,000 for each of the above two violations. DONE and ENTERED this 30th day of November, 1983, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 30th day of November, 1983. COPIES FURNISHED: Harold M. Braxton, Esquire 45 S.W. 36th Court Miami, Florida 33135 Steven M. Slepin, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. On February 23, 1983, the horse "Rock Steady" owned by Petitioner, Russell Michael, Jr., and trained by Ronnie Warren, ran in the seventh race at Gulf Stream Park. The horse finished first. Subsequent to the running of the aforementioned race, and in accordance with standard procedure, "Rock Steady" was led over to the state detention barn for the taking of a urine specimen. The specimen was placed in a sealed container and transported to the Division's laboratory with other specimens. Upon reaching the Division's laboratory, the specimen was logged in, assigned a number and subjected to various preliminary tests. Based on those preliminary tests, further tests were made and on March 3, 1983, the Division's laboratory reported that the specimen taken from "Rock Steady" contained at least 182 micrograms of phenylbutazone and/or its derivatives per milliliter of urine. (Respondent's composite Exhibit 1) "Rock Steady" was administered phenylbutazone in oral paste form at some time prior to the seventh race on February 23, 1983. (Post-hearing stipulation of the parties entered pursuant to a joint telecon on July 25, 1984) On April 28, 1983, Dr. Wayne C. Duer, 3/ Chief of the Division's Bureau of Laboratory Services, sent a split sample from the urine specimen taken from "Rock Steady" to Dr. Thomas Tobin in accordance with instructions of Respondent's counsel. (Petitioner's Exhibit 8) On or about that same date, Dr. Duer sent another split sample from "Rock Steady" to Dr. George A. Maylin, Director of the New York State Racing and Wagering Board Drug Testing and Research Program. Dr. Tobin reported an average amount in the sample of 125.1 micrograms of phenylbutazone per milliliter of urine. Dr. Maylin reported a sum total of 154.4 micrograms of phenylbutazone per milliliter of urine. (Petitioner's Exhibit 10) The methods employed by the Division laboratory, and which were utilized by Chief Duer, liquid chromatography, thin laver chromatography and ultraviolet spectrophotometry, are methods recognized as the "state of the art" for quantitating phenylbutazone in urine. Based on analysis of the specimen here in question on March 1 by Dr. Duer, an average amount of 182 micrograms of phenylbutazone per milliliter of urine was indicated. In reporting his results, Dr. Duer reported his findings by factoring in the various results and averaging to report the concentration of phenylbutazone in "Rock Steady's" urine specimen. All of the Division's analyses were conducted under Dr. Duer's direction and supervision. Dr. Duer has noted a variance of approximately 3 - 4 percent when analyzing any given sample. Samples can vary based on the exposure to air for long periods of time; samples left unsealed for long periods of time; samples analyzed over various time periods; the amount of alkaline in a urine sample and the physiology of an animal - all of which may fluctuate the phenylbutazone levels in the blood plasma of a given animal. However, as noted, a specimen analyzed soon after a race is apt to be more reliable than subsequent analyses. THE PETITIONER'S DEFENSE Petitioner takes the position that it should not be required to return the purse money because the sample analyzed is different from the sample taken from the horse owned by Petitioner, "Rock Steady"; that the testing procedures utilized by the Respondent are unreliable and the analyses show widely varying concentrations of the drug phenylbutazone and based on the varying calculations, there is no competent and substantial evidence upon which a finding or a requirement can be made herein requiring Petitioner to return the purse money for using the drug phenylbutazone. Respecting Petitioner's claim that the sample analyzed was not the sample taken from the Petitioner's horse "Rock Steady" or that somehow the samples were mishandled or otherwise confused, the evidence herein reveals that Dr. Duer analyzed the urine sample taken from the horse "Rock Steady" and it remained under his custody and control until he personally apportioned the sample such that it could be analyzed by independent laboratories at Cornell University in New York and at the University of Kentucky in Lexington, Kentucky. The analytical methods employed by the Respondent, under the direction of Dr. Duer, appear reliable and are generally recognized as the state of the art in analytical procedures for measuring the drug phenylbutazone. Based on the methods utilized and the fact that the urine sample was analyzed within a short period after "Rock Steady" ran in the seventh race on February 23, 1983, I find that the testing procedures and the results of the analysis were reliable. Finally, as to Petitioner's claim that the methods employed by Respondent lend to varying results, all of the experts herein related that the calculations may vary from one laboratory to the next in a range of approximately 3 - 4 percent. Given that degree of variance as the range within which a given sample may vary, that degree of variance does not alter the conclusion herein by Respondent that the Petitioner's horse competed with an excessive amount of a permitted drug in its system in violation of Rule 7E- 1.0612, Florida Administrative Code. It is so found.
The Issue The issue to be decided is whether disciplinary action should be taken against the Respondent's license as a medical doctor for the alleged violations of Chapter 458, Florida Statutes (1983), as set forth in the Administrative Complaints?
Findings Of Fact The Respondent is licensed as a medical doctor with the State of Florida, Board of Medical Examiners. The license, Number 28366, was first issued on February 11, 1976. The Respondent was licensed at all times relevant to this proceeding. October 5, 1983 Complaint. On or about July 7, 1982, the State Attorney of the Eleventh Judicial Circuit filed a ten (10) count Information against the Respondent. In the information it was alleged that the Respondent knowingly and unlawfully filed, attempted to file or aided and abetted in the filing of claims for services to recipients of state or federally funded assistance program benefits (the Florida Medicaid Program) in violation of Section 409.325, Florida Statutes. The services, according to the Information, were never rendered. On April 18, 1983, the State of Florida nolle prossed Counts 3 and 4 of the Information. On June 30, 1983, the State nolle prossed Counts 1, 2, 5, 7 and 9. The same day, the Respondent withdrew his original plea and plead guilt to the remaining counts: 6, 8 and 10 of the Information. As a result of the Respondent's guilty plea, he was found guilty on counts 6, 8 and 10 and adjudication was withheld. The Respondent was placed on probation for one (1) year and was required to repay $3,500.00 to the Florida Medicaid Program. The Respondent completed his probation, which was terminated early by the court, and made restitution to the Florida Medicaid Program. The Respondent stipulated that he plead guilty to Counts 6, 8 and 10 of the Information, that adjudication ways withheld and that the case was disposed of in the manner described above. According to the Respondent, he plead guilty on the advice of this counsel and as a matter of convenience (to himself and not "to all parties" as suggested by the Respondent in his proposed findings of fact). He did so despite his belief that he was not guilty. The Respondent's proposed finding of fact that his attorney never advised him that he could be in violation of Section 458.331(1)(c), Florida Statutes, irrelevant. July 27, 1983 Complaint. On March 24, 1981, the Respondent saw Ana Gonzalez as a patient in his office. Ms. Gonzalez was thirteen years old at the time of her first visit (Ms. Gonzalez's date of birth was incorrectly listed as "8-7-82" in the Respondent's records). Ms. Gonzalez, according to the Respondent's record of Ms. Gonzalez's visits (hereinafter referred to as the "Patient Records") complained of "pain of mild intensity on lower left quadrand [sic], inradiating [sic] to right lower quadrant and left lumbar fossa." The Patient Records, which were all in the same handwriting, 1/ also indicate that Ms. Gonzalez had low back pain, dark urine which looked like blood and a fever of 100.4 degrees. A physical examination of Ms. Gonzalez found nothing abnormal except pain in both lower quadrants of the abdomen and the left lumbar fossa of the back. The Respondent made a probable diagnosis of pyelonephritis and ordered a SMAC 26, a Complete Blood Count ("C.B.C."), an urinalysis, an E.K.G. and a chest x-ray. The Petitioner has proposed a finding of fact that the chest x-ray and the E.K.G. were not referred to in the Patient Records. This proposed finding is incorrect. The Respondent did, however, order a kidney, urethra and bladder x-ray ("K.U.B.") which was not recorded in the Patient Records. The Respondent also prescribed an antibiotic. The results of the E.K.G. and the chest x-ray are not noted in the Patient Records; nor does the E.K.G. print-out include any findings. The SMAC 26 showed nothing abnormal. The C.B.C. also showed nothing abnormal and the K.U.B. was negative. Finally, the urinalysis showed that the patient's urine was yellow, clear and contained no blood. The charges for the first visit were $30.00 for the examination, $182.00 for the SMAC 26 (charged at $7.00 per 26 procedures), $6.00 for the urinalysis, $10.00 for the C.B.C., $40.00 for the chest x-ray and $40.00 for the E.K.G. No charge was made for the K.U.B. The patient was next seen by the Respondent on March 31, 1981 (erroneously reported as March 31, 1982 in the Patient Records). The Petitioner's proposed finding of fact that the Patient Records were kept in the same pen is therefore incorrect. The Patient Records indicate the following: "The patient is feeling a little better of pain. No fever. Persist urine dark." The Patient Records do not indicate that Ms. Gonzalez was examined on this visit. The Respondent continued the antibiotic and ordered the following tests: a C.B.C., a K.U.B. and an intravenous pyelogram ("I.V.P."). The I.V.P. was reported as negative in the Patient Records. The C.B.C. again found no abnormalities. The K.U.B., as testified to by the Respondent, was also negative. The Respondent testified that he ordered another K.U.B. on this visit because he again found blood in the patient's urine and because he believed that you can never tell when a test will result in a positive finding. The Petitioner has proposed the following finding of fact with regard to the March 31, 1981 visit: Again, the tests results obtained from the laboratory show that the urine is not discolored and that the urine does not contain blood, in contradiction with the handwritten medical record of the Respondent. Although this proposed finding is correct with regard to tests performed on the March 24, 1981 visit, no urine test was performed on the March 31, 1981 visit. The charges for the March 31, 1981, visit included $30.00 for the examination, $10.00 for the C.B.C., $40.00 for the K.U.B. and $80.00 for the I.V.P. The third visit by Ms. Gonzalez was on April 7, 1981. On this visit, Ms. Gonzalez was feeling much better (the "pain was very mild"), but the Respondent determined there was still blood in her urine. The Patient Records again do not indicate the results of any physical examination. The Respondent ordered an urinalysis which found that her urine was yellow. Although the Respondent testified in his deposition that the Patient Records for the April 7, 1981 visit were complete, billing records show that a charge for an I.V.P. was made for April 7, 1981 which was not recorded in the Patient Records. The Respondent admitted in his deposition that no I.V.P. was performed and stated that the charge for $80.00 was a mistake. The Respondent stated that he did perform a K.U.B. or I.V.P. on this visit because it was too soon after the last K.U.B. and I.V.P. tests. Instead of an I.V.P., the Respondent testified in his deposition that Ms. Gonzalez received physiotherapy for which she should have been charged only $20.00. The physiotherapy was ordered because of the patient's complaints of lower back pain and consisted of heat treatment/ultrasound. Petitioner, in its proposed findings of fact, indicates that the Respondent took Ms. Gonzalez, off the antibiotic he had prescribed earlier at the April 7, 1981 visit, citing "(Depo., page 20)." This proposed finding is not supported by the record. Other charges for the April 7, 1981, visit included $30.00 for the examination and $6.00 for the urinalysis. The next visit by Ms. Gonzalez was on April 14, 1981. The Patient Records do not indicate Ms. Gonzalez's condition or that an examination was performed. The Patient Records only indicate that the Respondent suggested hospitalization of Ms. Gonzalez so that more tests could be made and that her father refused. The Respondent ordered a K.U.B. (which was negative) and a SMAC 26 (which found no abnormalities). The antibiotic was also changed. The charges for this visit included $30.00 for the visit, $40.00 for the K.U.B. and $182.00 ($7.00 per 26 procedures) for the SMAC 26. Again the bill included a charge of $80.00 for an I.V.P. which, according to the Respondent, was a mistake in billing. The Respondent actually performed physiotherapy which should have resulted in a $20.00 charge. The final visit occurred on April 20, 1981. The Patient Records for this visit indicated the following: I insisted some UROLOGY must consultate this patient and she refused to see another Doctor and culture and sensitivity. She says she does not want to go to the rest room. She decides pick up the urine. I decide another I.V.P. because persist a mild hematuria [blood]. Mr. Gonzalez again refused to admit his daughter to a hospital as suggested by Respondent. The Respondent recommended hospitalization because his tests were not finding anything and he therefore wanted to run a kidney scan. There is no indication in the Patient Records as to whether an examination was performed. The Respondent ordered a K.U.B., an I.V.P. and a C.B.C. The results of these tests are not recorded in the Patient Records but the Respondent has testified that they were negative. On this visit the Respondent indicated his diagnosis was pyelonephritis, which he described as "kidney infection." Charges for this visit were $30.00 for the examination, $40.00 for the K.U.B., $80.00 for the I.V.P. and $10.00 for the C.B.C. Pyelonephritis is an inflammatory reaction of the kidney involving the kidney tissue and the pelvis of the kidney. It is usually accompanied by severe toxicity, a temperature for a child the age of Ms. Gonzalez of 104 to 105 degrees and extreme chills. It is a serious infection. The diagnosis of pyelonephritis on March 24, 1981 and April 20, 1981, by the Respondent was not medically justified. Ms. Gonzalez did not have any of the symptoms normally associated with pyelonephritis. The results of all of the tests performed by the laboratory 2/ and the Respondent were negative. Laboratory test results conclusively showed that Ms. Gonzalez's urine was yellow, and contained no blood. Additionally, the Respondent should have performed a urine culture, a blood culture and a sensitivity test before concluding that the patient was suffering from pyelonephritis. The cultures would have determined if there was an organism present and, if so, what type. The sensitivity test would have shown what the organism was sensitive to. None of these tests were performed. Most of the tests ordered by the Respondent were also not medically justified. The only tests which were clearly medically justified were the SMAC 26, C.B.C. and the urinalysis ordered on March 24, 1981. Most of the remaining tests were not medically justified as hereinafter discussed. The E.K.G. performed by the Respondent on March 24, 1981, was not medically justified. The Respondent indicated that he ordered an E.K.G. because he was looking for valvular problems with Ms. Gonzalez's heart. An E.K.G., however, only, shows the electrical activity of the heart. The Respondent also testified that the E.K.G. was performed because he suspected a kidney problem. According to the Respondent, if there was a problem with Ms. Gonzalez's kidneys, it could have affected her E.K.G., especially in light of her age. No problem was found according to the Respondent. The chest x-ray performed on the March 24, 1981 visit was not medically justified. This test resulted in exposure of Ms. Gonzalez to x-rays which could be harmful to her. The Respondent, based upon his deposition testimony, believes that a chest x-ray should be taken of anyone who comes to his office as a patient and has insurance. With regard to Ms. Gonzalez, he indicated that her parents requested the chest x-ray but admitted there was no medical cause for her to receive a chest x-ray. The K.U.B. tests performed on March 24, 1981, March 31, 1981, April 14, 1981 and April 20, 1981 and the I.V.P. tests performed on March 31, 1981 and April 20, 1981 were not medically justified. These tests also resulted in exposure of Ms. Gonzalez to x-rays which could be harmful to her; especially the I.V.P. test which has six to seven times the radiation level of a K.U.B. The I.V.P. was also a dangerous procedure because it is an invasion procedure (the introduction of a foreign substance to the body). Even the Respondent must have realized the possible problem with the I.V.P. since he indicated that this test was not performed on April 7, 1981, because it was too soon after the test performed on March 31, 1981. The second SMAC 26 test, performed on April 14, 1981 was not medically justified. The test, according to the Respondent, was performed because the blood in Ms. Gonzalez's urine persisted. The evidence clearly shows that there was no blood in her urine, however. A SMAC 26 is a single laboratory procedure whereby one blood sample is divided into 26 parts (or some other number of parts) which are diagnosed or read by a machine at the same time. It is not 26 separate tests; it is a single automated test. The method by which the Respondent billed for the SMAC 26 tests performed on March 24, 1981 and April 14, 1981, (charging $7.00 for each of 26 tests) was not justified. The Respondent billed for the S4AC 26, which gas performed by Central Medical Laboratory, because he believed that the insurance company would pay what he hoped to receive for the test: $60.00-$80.00. If he had only billed $60.00 for the test he stated that he would only have received $6.00 to $10.00 from the insurance company. The Petitioner has proposed a finding that the SMAC 26 billing was "outrageously high." The evidence supports a finding that the charge was excessive. Finally, the C.B.C. tests of March 31 1981 and April `20, 1981 and the physiotherapy performed on April 7, 1981 and April 14, 1981 were not medically justified. Dr. Handwerker's testimony was consistent with the findings in this Recommended Order with regard to the lack of medical justification for most of the tests. The Respondent stated that he agreed in part and disagreed in part with Dr. Handwerker's testimony. When asked to identify those areas of Dr. Handwerker's testimony he disagreed with, the Respondent unsuccessfully attempted to rebut Dr. Handwerker's testimony with regard to the E.K.G. and chest x-ray and with the fact that the tests were repeated to often. 3/ The Respondent did not attempt to rebut any other part of Dr. Handwerker's testimony, which was based upon his examination of the Patient Records and the Respondent's deposition (she did not examine Ms. Gonzalez). Based upon the foregoing, it is clear that the Respondent failed to practice medicine in conformance with the generally accepted and prevailing standards of medicine in the medical community. The Respondent also failed to, practice medicine with the level of care, skill and treatment recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and conditions. The father of Ms. Gonzalez testified on behalf of the Respondent. Mr. Gonzalez stated that he was satisfied with the Respondent's medical care of the Gonzalez family and that he would continue to retain the Respondent. Letters submitted by the Respondent also indicated that friends, associates and his pastor believe the Respondent is honest, experienced, qualified and of high moral and ethical standards. Although the Respondent testified that he had done the best he could do for Ms. Gonzalez, the unrebutted testimony supports a conclusion that his best was not good enough. Finally, the Respondent's testimony to the effect that he had not intended to exercise influence over Ms. Gonzalez or to deceive her in his medical treatment of her is not believable in light of the facts.
Recommendation Based on the foregoing Findings of Fact and Conclusions RECOMMENDED: That Respondent be found guilty of violating Section 458.331(1)(c), Florida Statutes (1983), by being found guilty, regardless of adjudication, of a crime in any jurisdiction which directly relates to the practice of medicine or to the ability to practice medicine. It is further RECOMMENDED: That Respondents be found guilty of violating Section 458.331(1)(l), Florida Statutes (1983), by employing a trick or scheme in the practice of medicine when such scheme or trick fails to conform to the generally prevailing standards of treatment in the medical community. It is further RECOMMENDED: That Respondent be found guilty of violating Section 458.331(1)(o), Florida Statutes (1983), by exercising influence on a patient or client in such a manner as to exploit the patient or client for financial gain of himself, as a licensee. It is further RECOMMENDED: That Respondent be found guilty of violating Section 458.331(1)(t), Florida Statutes (1983), by failing to practice medicine with the level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. It is further RECOMMENDED: That the Respondent's medical license be suspended for a period of one (1) year and that the Respondent be placed on probation for a period of three (3) years, upon reinstatement of his license, subject to such conditions and terms of monitoring and continuing medical education as may then be prescribed by the Board of Medical Examiners. DONE and ORDERED this 22nd day of February, 1985, in Tallahassee, Florida. LARRY J. SARTIN Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 FILED with the Clerk of the Division of Administrative Hearings this 22nd day of February, 1985.
