The Issue The issues to be resolved in this case concern whether Proposed Rules 590-3.002, 590-5.003, 590-3.003, 590-5.004, and 0094 Sf =e 590-7.001, Florida Administrative Code, which substantially revise and replace existing provisions of the same rules are invalid on the basis that they are allegedly an invalid exercise of delegated legislative authority for reasons set forth more ‘fully in Section 120.52(8), Florida Statutes.
Findings Of Fact 1. The Respondent, Agency for Health Care Administration, is an agency of the State of Florida charged with administering licensing of clinical laboratory personnel in pertinent part. This responsibility was formerly that of the Department of Health and Rehabilitative Services. 2. The Florida Association of Blood Banks, the Petitioner, is a non-profit organization made up of community blood banks throughout the state of Florida. The organization represents the interest of individual member physicians, technicians, technologists and other health care workers who work in blood banks, hospitals, community blood banks, and blood centers throughout the state as well as institutional blood banks and transfusion services. 3. The association is organized to assure good blood banking practices in the state of Florida in order to improve safety of the blood supply in the state for the public. Both the individual and institutional memberships of the association are affected by the proposed rule in terms of both institutional community blood centers and individual technicians and technologists working in blood centers because changes to licensure provisions will make employment more difficult and otherwise make qualified staff prospectively ineligible for employment and thus make it more difficult for blood banking entities in hiring qualified personnel. ° 0096 _€ we ae 4. Hospital-based blood banks which perform transfusion services will also be impacted because changes in the proposed rules may disqualify certain technologists and technicians from -working in blood banks, may increase costs and make it more. -.-. difficult for these blood banks to replace qualified staff. It has not been shown that the changes will improve the safety or quality of health care provided. 5. The proposed rules will impose education and training programs which are not adequate for the specialized procedures performed by the blood banks, thus making licensure more difficult. They will provide less qualified applicants. 6. The Petitioner has demonstrated that it represents the interests of its institutional and individual members and that a substantial number of those members will be affected by the proposed rules. The rules are within the scope of interest which the Petitioner/association was organized and is operated to protect. 7. Clinical laboratory personnel are defined to include technologists and technicians who perform or are responsible for performing laboratory test procedures. This definition includes personnel in blood banks performing laboratory test procedures but does not include trainees, persons who perform screening for blood banks or plasmapheresis centers, phlebotomists or persons employed by the clinical laboratory to perform manual pre-testing duties, clerical personnel or those with other administrative responsibilities. 8. Clinical laboratory personnel and blood banks currently C C perform test procedures in the field of immunohematology and the current specialization of blood banking. 9. All laboratories must comply with the conditions imposed under the Federal Clinical Laboratory Improvement Amendments of 1988 ("CLIA"). Those regulations appear at 42 Code of Federal Regulation Section 493.1, et. seq. The CLIA regulations, however, do not relate to licensure of laboratory personnel themselves. CLIA imposes specific qualifications and requirements for individuals who perform "high complexity testing." Compliance with these regulations requires that each individual performing such testing "possess a current license issued by the state in which the laboratory is located as well as certain other requirements which are discussed herein." The CLIA rules provide detailed and specific regulations concerning performance of laboratory test procedures. 10. The proposed rules at issue substantially modify the existing laboratory personnel rules and eliminate the specialty designation in blood banking. The following proposed rules delete the specialty designation in blood banking: A. The specialty designation of blood banking is deleted from the provision pertaining to general requirements of clinical laboratory personnel training programs (Fla. Admin. Code R. 59)-3.001); B. The specialty designation in blood banking is deleted from clinical laboratory personnel training programs (Fla. Admin. Code R. 590-3.003); c. The licensing procedure for technologists with a specialty in blood banking is deleted (Fla. Admin. Code R. 590- 5.004); and 0098 11. = ¢ ~e D. The licensing psocedure for technicians with a specialty in blood banking is deleted (Fla. Admin. Code R. 590-5.004); and E. Provisions providing for licensure examinations for the specialty in blood banking are deleted (Fla. Admin. Code R. 590- 7.001). Substantial changes are made in technician and technologist training and experience requirements. These changes include: 12. A. Education and training requirements for licensure as a technician are changed from 400 hours of instruction in a designated specialty under the existing rules toa minimum of one year of integrated instruction covering all categories, including categories of clinical chemistry, hematology, immunohematology, microbiology and serology immunology. (Fla. Admin. Code R. 590- 3.001(6) (1)). B. Experience requirements for licensure as a technologist are changed from 400 hours of training and experience in a designated specialty (no longer including blood banking) to five years of pertinent clinical laboratory experience with one year of experience in each category for which licensure is sought (Fla. Admin. Code R. 590- 5.003(1)(g)). Alternatively, three years of pertinent clinical laboratory experience of which one year shall be in the category for which licensure is sought for an applicant with a baccalaureate degree. The laboratory personnel licensure rules have been in existence for a substantial period of time but until recently did not provide for a specialty designation in blood banking. Because of new laboratory tests for specific diseases which were imposed on blood banks pursuant to federal regulation issued by the Federal Food and Drug Administration and the need for specially trained personnel in order to perform these tests, a 0099 C C task force was formed in 1988 and 1989 to work with the Department of Health and Rehabilitative Services to develop a blood banking specialty under the laboratory personnel rules. This specialty was created by rules adopted in May of 1995. The specialization was intended to focus training in specific areas of work in blood banks in order to ensure that laboratory personnel working in blood banks complied with controlling federal regulations. 13. A comprehensive examination for this blood banking specialty was developed and adopted by rule in December of 1995. See Rule 590-7.001, Florida Administrative Code. The examination was administered for the first time in September of 1996. 14. The proposed rules were published in the August 23, 1996, Florida Administrative Weekly. The agency offered no testimony or evidence that any change in circumstances that occurred with respect to licensure of laboratory personnel in the specialization of blood banking. Further no evidence was offered that any difficulty had been created in maintaining the blood banking specialization. There was no evidence of the existence of any problem with respect to specialized training and educational requirements for licensed technologists and technicians. To the contrary, the evidence indicates that failure to provide specialized education for training in blood banks would create significant problems for blood banks and their personnel. 15. The agency offered several reasons for the proposed changes at the hearing. These included the agency's desire to 0700 _C€ CC minimize proliferation of specialties; a desire to make licensure dependent upon the discipline related to the particular laboratory test procedures performed and a desire to make the state regulatory scheme consistent with CLIA. 16. The proposed rules limit the categories in which training and education are provided for licensure to certain limited categories. These are the categories of Chemistry, Hematology, Immunchematology, Microbiology, and Serology/Immunology. The department contends that these categories of tests are "disciplines" while blood banking is not. It maintains that the categories of Histology, Radioassay and Blood Gas Analysis are also disciplines. (See Proposed Rules 590-3.003(2) (a) (b) (c) and (d), Florida Administrative Code). However, each of these areas involves performance of one or more test procedures from a specialty category. Thus these categories are no more discrete "disciplines" than is blood banking. 17. The agency contends that while immunohematology is synonymous with blood banking, the "donor processing" aspect of blood banking is not a disciplined-based specialty and should therefore be deleted. 18. The disciplines which the department intends to reccgnize in its proposed rules are Chemistry, Hematology, Immunohematology, Microbiology, and Serology/Immunology, as well as Histology, Radioassay, and Blood Gas Analysis. Except for Radioassay and Blood Bas Analysis these categories are based upon laboratory tests proficiency standards described in the federal regulatory scheme known as CLIA. CLIA regulations contains 8 0101 CC C_ specific proficiency standards for tests performed in these general categories. A blood bank performs a limited number of tests in each category, to wit, Immunology (42 CFR Section 493.027), Routine Chemistry (42 CFR Section 493.931), Syphilis Serology (42 CFR Section 493.923), Hemotology (42 CFR Section 493.941), and Immunohematology (42 CFR Section 493.959). Each CLIA category includes numerous tests within the category. While CLIA does not provide for personnel standards, the proficiency tests' standards are the basis upon which personnel are licensed in the various specialty categories. 19. While clinical laboratory procedures are utilized to assist in the diagnosis and treatment of disease, blood is considered a product. Thus standards for performing clinical laboratory test procedures and testing blood are different. For this reason CLIA provides specific standards respecting the activities of blood banks. These provisions includes standards concerning the operation of a transfusion service and blood bank pursuant to standards of immunohematology (42 CFR Section 493.1271), standards governing immunohematological collection, processing dating periods, labeling and distribution of blood and blood products (42 CFR Section 493.1273), standards for blood and blood products storage (42 CFR Section 493.1275), standards for the provision of testing (42 CFR Section 493.1279), standards for the retention of samples of transfused blood (42 CFR Section 493.1283), and standards for the investigation of transfusion reactions (42 CFR Section 493.1285). 9 0102 ~C€ = 20. The CLIA standards incorporate provisions of 21 CFR Section 640 and 21 CFR Part 606, pertaining to blood and blood product collection, processing and distribution. Pertinent regulations adopted by the Food and Drug Administration Act provide comprehensive regulatory requirements controlling the manner, method and procedures of a blood bank in collecting, testing, processing, and storing blood. See generally 21 CFR Section 640.1 through Section 640.56. Additionally, other provisions of the Act provide extensive regulation pursuant to provision of good manufacturing practices for blood and blood components. See 21 CFR Section 606.3 through Section 606.17. Thus, these regulations provide the primary regulation of the performance of laboratory procedures by blood bank personnel. They are the focus of a blood bank training and education program. The blood bank specialty examination provided for by the existing rules which the department proposes to delete, incorporates applicable provisions of the above-described federal regulations. The preponderant evidence does not demonstrate that the agency considered the import of the CLIA and Food and Drug Administration provisions in proposing to delete the blood bank specialization. 21. A blood bank performs a limited number of test procedures in a number of different categories. These include a single Serology test (Syphilis), two Immunology tests (HIV and hepatitis), a single Chemistry test (ALT), several Hemotology procedures and several Immunohematology test procedures. Although CLIA provides proficiency standards for many laboratory (on) 103 - C test procedures in each category, a blood bank performs only the specific procedures identified by FDA regulations. The FDA regulations, previously referred to, specify the methodology and manner of performing these specific tests. 22. Performance of these test procedures in a blood bank is fundamentally different than that which occurs in a general laboratory. In a general laboratory, personnel are trained to perform a multiple of tests and to interpret the results for purposes of diagnosis. It is essential that personnel be able to interpret tests and determine if additional tests are required. No FDA regulations control the performance of these test procedures. Rather, CLIA describes general proficiency standards for performance of each specialty and sub-specialty tests procedures. (See 42 CFR Section 493.812 through Section 493.865 42 CFR Section 493.909 through Section 493.959). These performance standards provide the basis for education and training in the licensure of personnel. However, blood banks provide specific training in the performance of test procedures required by CLIA and the FDA. This type of training is not available in a general medical technologist program nor ina training program which was not provided by a blood bank. 23. In proposing rules deleting the blood bank specialty, the agency has admitted that it did not consider the import of any of the federal regulations, described above, pertaining to blood banks, nor did it consider the provisions of CLIA pertaining to unique standards and procedures applied to blood banks in adopting personnel training and licensure provisions. cD aed ; (om) Further, although the agency acknowledges that the training and educational programs necessary for training laboratory personnel licensed and employed in blood banks would require inclusion of the relevant federal regulations, the deletion of the blood banking specialty would effectively delete education and training under these provisions. . 24. Part of the agency's justification for the proposed rules was to assure consistency between the provisions of CLIA and the clinical laboratory personnel rules. However, representatives of the department admitted that the proposed rules regarding training programs for licensure were not consistent with CLIA and in fact, would exceed the CLIA requirements. The specific provision of CLIA pertaining to experience and training at issue provides as follows: Section 493.1489 Standard: Testing Personnel. Qualifications Each individual performing high complexity testing must: A. Possess a current license issued by the state in which the laboratory is located, if such licensing is required; and B. Meet one of the following requirements: k* ke * (2) (B) have laboratory training that includes either of the following: kek ek (2) At least three months documented laboratory training in each specialty in which the individual performs high complexity testing. C C 2S. This provision is consistent with existing rule provisions which require 400 clock hours of pertinent clinical laboratory experience in each specialty for which licensure is sought. (See Rules 59)-5.003(2) (a)1, Florida Administrative Code). Additionally, this provision in CLIA is consistent with clinical laboratory training programs for the technicians which require a minimum of 400 clock hours of instruction in each specialty (See Rule 590-3.003(3), Florida Administrative Code, Rule 59)-5.004(2) (b), Florida Administrative Code). The proposed rules, however, delete these provisions and instead require participation in a one year educational program for each specialty in which licensure is sought or one year of experience in each category for which licensure is sought. (See Proposed Rule 590-3.001(6) (1) and 590-5.003(1) (g), Florida Administrative Code). 26. Change of the experience and training requirement of 400 hours (approximately three months) to one year represents a substantial departure from the CLIA requirements. The agency offered no preponderant evidence explaining the reason for the departure. Moreover, such an inconsistency contradicts one of the stated goals expressed by the agency - to make the personnel standards consistent with CLIA. 27. Change of the experience and training requirements from 400 hours to one year would impose unnecessary and unreasonable requirements in training blood bank personnel. A blood bank performs only a limited number of tests in several categories. Training for each procedure is based upon federal regulatory 13 0106 _C _C oe requirements imposed by CLIA and the FDA. Thus, training of laboratory personnel to perform a wide array of tests in each category as proposed is unnecessary, costly and counterproductive. 28. For personnel employed with broad-based designations, the blood bank is forced to provide additional specialized education and training because of the unique nature of the test procedures performed. Thus, 400 hours of training in each specialty in which tests are to be performed in a blood bank setting (rather than one year) appears to be a reasonable allocation of time. 29. Training programs have been established which provide training in each specialty consistent with these requirements and which have been approved by the state as recently as in the last year. Adoption of the longer training and experience requirements in the proposed rules would result in more difficult recruitment of qualified personnel, will increase personnel costs and will not produce more qualified, competent personnel. 30. The agency offered as justification for the change the fact that under the existing regulatory scheme, a high school graduate who obtained 400 hours of education and/or training could qualify as a technician. Although the agency appears to imply that something is wrong with this standard, it offered no evidence or testimony that such individuals would be ill-equipped or ill-trained to perform laboratory test procedures for which they had been thus trained. 0107 ~ CL 31. The effect of the proposed change as it would apply to personnel employed by a blood bank would be, in many instances, to change the education and experience requirements from 400 hours in the specialty licensure obtained to one year in each specialty. Thus, in a blood bank in which personnel were employed to perform limited testing in each of four different areas, a minimum of four years of experience and/or training would be required. These are significant and substantial changes from the requirements of the present rules. 32. The agency has suggested that there is no interest in the blood banking designation because no one is currently designated in that specialty. However, it is apparent that the examination for this specialty has only recently been developed and the first examination was only given in September of 1996, approximately one month after the agency proposed the rules at issue which would delete that specialty. Even though it was not well-advertised, sixty-two people took the blood bank examination, including ten who took only the blood bank specialty. There was evidence that there are many individuals who are interested in taking the examination and making application for the blood bank licensure designation.
Conclusions For Petitioner: Thomas J. Guilday, Esquire Rex D. Ware, Esquire Huey, Guilday and Tucker, P.A. Post Office Box 1794 Tallahassee, Florida 32302 For Respondent: Edwin A. Bayo, Esquire Office of the Attorney General The Capitol, Plaza Level 01 Tallahassee, Florida 32399-1050
Appeal For This Case A party who is adversely affected by this final order is entitled to judicial review pursuant to Section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing one copy of the notice of appeal with the Agency Clerk of the Division of Administrative Hearings and a second copy, accompanied by filing fees prescribed by law, with the District Court of Appeal, First District, or with the District Court of Appeal in the Appellate District where the party resides. The notice of appeal must be filed within 30 days of rendition of the order to be reviewed.
The Issue The issues are whether, during 2015, Respondent held himself out as a “doctor of medicine,” even though he did not hold a license to practice medicine in Florida, in violation of section 456.072(1)(m), Florida Statutes (2014); whether, during 2015, Respondent exceeded the scope of his advanced practice registered nursing (APRN)1 license modifier by removing adipose tissue from a patient’s abdomen, performing intravitreous injections of the processed tissue into both eyes of a patient, and failing to have a protocol in place for the removal of abdominal adipose tissue and the intravitreous injection of any material into a living person, in violation of section 456.072(1)(o); and, if so, the penalty that should be imposed.
Findings Of Fact The Parties Petitioner is the state agency charged with regulating the practice of nursing pursuant to section 20.43, and chapters 456 and 464, Florida Statutes. Respondent was born and raised in Cuba, where he obtained a licensed practical nurse degree and, in 1995, Respondent earned a Doctor of Medicine degree and moved to Florida. On two occasions, Respondent failed to pass the examinations in Florida for licensure as a medical doctor. Respondent obtained a Florida license as a registered nurse in 2005 and, in March 2015, a license modifier as an APRN. Respondent’s highest relevant education in the United States is a Master of Science degree in nursing awarded in December 2014 from the south Florida campus of the University of Turabo. A couple of months later, the American Academy of Nurse Practitioners certified Respondent as a Family Nurse Practitioner. The transfer of processed fat tissue into the eye is thought, by some, to treat conditions of the eye, such as dry macular degeneration, to be part of regenerative medicine. This so-called “stem cell injection procedure” (“procedure”) comprises three steps: (1) removing the fat tissue, usually from the abdomen; (2) processing the fat tissue to prepare it for injection; and (3) injecting the processed fat tissue into the vitreous cavity at the back of the eye. Following the completion of his medical education in Cuba, Respondent obtained varying degrees of training and experience in the each of the three steps of the procedure. Respondent testified that he trained with a “specialist,” possibly an ophthalmologist, in intravitreal injections. This covered such topics as the choice of syringe, the preparation of the patient, maintaining an open eye, the choice of a substance to stabilize the inside and outside eye, and the angle of the needle to the surface of the eye at the point of injection. Respondent also obtained training in intranasal and intraarterial injections, the latter of which is the more complicated. Respondent obtained a certificate in Mexico for completing the training in the removal of tissue from bone marrow. Respondent did not detail his training or experience in processing removed fat tissue. Through much of Latin America, Respondent has injected processed fat tissue, at the rate of about ten patients over one week, and has trained other healthcare providers to perform these procedures. Respondent also testified that he had performed a dozen intravitreal injections of processed fat tissue in Mexico and Chile prior to the three injections at issue in this case, so it seems that most of his experience did not involve intravitreal injections. Respondent’s only evidence of purported “stem cell” experience was assisting in bone marrow aspiration, not surgical adipose tissue removal or intravitreal injections. Respondent admitted that he had never performed intravitreal injections under the supervision of an ophthalmologist, a medical doctor of any type, or in a supervised training program prior to performing intravitreal injections on Patients E.K., E.N., and P.B. in May and June of 2015. Respondent failed to provide any evidence that he was educated or supervised by a licensed physician in the performance of these procedures prior to performing them on Patients E.K., E.N., and P.B. Performance of the Procedure by Respondent at the Clinic Respondent’s first intravitreal injection of fat tissue at the Clinic took place in April 2015, about one month after he had completed the educational requirement for this APRN license modifier. Having retained Respondent as an independent contractor, the Clinic called him a few days before an upcoming intravitreal stem cell injection to confirm his availability. The Clinic paid Respondent $500 per procedure, for which it charged each patient $5000. Although the Clinic operated this program as an FDA- registered clinical trial, all procedures were “patient funded treatment,” and the Clinic was not affiliated with any educational or research institution investigating stem-cell treatment of eye diseases or disorders. The three patients involved in this case are, or were, E.K., P.B., and E.N. E.K.’s procedure took place on May 15, 2015, and P.B. and E.N.’s procedures took place on June 16, 2015. Each patient suffered from dry macular degeneration. Each patient was sighted at the time of the procedure, at the end of which, each patient was substantially blind. At the time of each patient’s procedure, E.K., who died five years after her procedure, was 89 years old and resided in Oklahoma. P.B. was 77 years old and resided in southwest Florida, and E.N. was 72 years old and resided in Missouri, where she had taught research methods to graduate students at the University of Missouri. At the time of the subject procedures, the Clinic was affiliated with Bioheart, Inc., a publicly traded corporation. Key employees of the Clinic included Kristin Comella, who served as the chief scientist of the Clinic and chief scientific officer of Bioheart and holds bachelor’s and master’s degrees in chemical engineering, and Dr. Antonio Blanco, who is an internist in Hollywood, Florida, with 26 years of practice and the medical director of the Clinic and holds a medical degree from Georgetown University. The Clinic’s website adds that Ms. Comella is in the top 50 of global stem-cell influencers. E.K. and E.N. testified that they learned about or confirmed their interest in the Clinic by an online search of clinical trials of stem-cell treatment for dry macular degeneration. Neither patient differentiated between patient-funded clinical trials, such as these, and clinical trials whose treatment costs were subsidized by research centers, universities, hospitals, and pharmaceutical manufacturers. E.K.’s medical records do not include any representations as to Respondent’s status as a healthcare provider. E.K. and her niece, who accompanied her, arrived in Fort Lauderdale in sufficient time for E.K.’s pre-operative appointment with Dr. Greenbaum, an ophthalmologist employed with the Hollywood Eye Clinic. Until she spoke with Dr. Greenbaum, E.K. believed that Dr. Greenbaum would perform the procedure, based on what she had been told by Clinic staff. At the pre-operative exam conducted by Dr. Greenbaum, E.K. and her niece learned that Dr. Greenbaum would not be performing the procedure on the following day. Dr. Greenbaum mentioned Respondent’s name, so the niece had her husband research Respondent that night, but his research revealed nothing. The next day, E.K. and her niece were introduced to Respondent by a Clinic employee, likely Ms. Comella. The niece does not recall if the employee referred to Respondent as a physician, but she assumed that he was. She recalled only that the clinic employee introduced him by saying that he was very experienced and had performed lots of stem cell injections of this type. The niece recalled distinctly that Respondent introduced himself as a “medical doctor.” Respondent denies doing so. The niece’s testimony is credited based on the totality of the evidence. P.B.’s medical records do not include any representations as to Respondent’s status as a healthcare provider except for the operative report, which bears Respondent’s signature above “Physician Signature.” Well prior to the date of the procedure, P.B. called the Clinic, spoke with Dr. Greenbaum and Ms. Comella, who informed her that Dr. Greenbaum would perform the procedure. P.B. later arrived in Fort Lauderdale in time for her pre-operative exam by Dr. Greenbaum, whose office told P.B. that Dr. Greenbaum was no longer performing the procedure. P.B. assumed that another ophthalmologist would perform the procedure. The next day, P.B. and a friend or family member, who had accompanied her on the trip, met Ms. Comella and Respondent, whom Ms. Comella introduced as “Doctor Perez,” and he did not correct her. P.B. asked him if he was an ophthalmologist, and Respondent replied, “no, but I’m well-trained in this procedure.” He never mentioned that, in terms of Florida licensing, he was only a registered nurse or APRN and was not a physician. E.N.’s medical records include the most references to Respondent’s status as a healthcare provider. These records include a page from the Clinic’s website that was initialed and dated by E.N., and prominently identifies Respondent as a “DM, NP-C,” meaning “doctor of medicine” and “nurse practitioner--certified.” The accompanying text discloses that “Dr. Alejandro Perez” graduated from the University of Havana Medical School in 1993 as a “Doctor in Medicine”; since 2007, he has conducted innovative research on regenerative medicine with a focus on adult stem cells from bone marrow and adipose tissue; “Dr. Perez” has worked on adult stem cells to treat multiple chronic diseases; “Dr. Perez” trains national and foreign “Medical Doctors” on the use of adult stem cells; and that “[h]e currently holds a National Board Certification as a Family Nurse Practitioner.” In three out of five references, the document refers to Respondent as a “doctor,” never disclosing that he was not a licensed physician in Florida. This website page may have come into existence after Respondent’s first patient encounter in this case in May 2015. Ms. Comella introduced Respondent to E.N. and her sister, who had accompanied her on the trip, as “Dr. Alex Perez.” Without stating his specialization, Respondent told E.N. that he was a “medical doctor” and was proud of his “profession,” which, in context, meant the practice of medicine, not nursing. Respondent wore a white jacket with a printed name tag, “Alex Perez, M.D.” At no time did Respondent reveal that his Florida licensure was as a registered nurse or APRN and not a physician. Lack of a Written Protocol As a licensed APRN, Respondent was required by section 464.012 and Florida Administrative Code Rule 64B9-4.002 to practice under an APRN protocol filed with the Board of Nursing. At all times material, the scope of practice of a certified family nurse practitioner licensed in Florida as an APRN did not include performing any invasive procedures, including surgical removal of adipose tissue or intravitreal injections, without an APRN Protocol on file that ensured physician supervision. By letter dated March 12, 2015, the Board of Nursing notified Respondent that he was required to have an approved APRN protocol on file with the Department “within 30 days of employment.” Respondent was employed in March 2015 at the time of receipt of the above-referenced letter. In May and June 2015, Respondent was aware of the protocol requirement and the scope of practice as an APRN. He admitted that he received the March 12, 2015, letter and failed to provide a protocol as instructed. At no time did Respondent ever obtain or file with the Board of Nursing a written protocol between him and a supervising licensed physician authorizing Respondent to perform the subject procedure. Respondent claimed, alternatively, that Drs. Greenbaum and Blanco served as his supervising physicians, but admitted that they served remotely and without a signed written protocol. Harm to the Patients The impact on the three patients of this unauthorized procedure performed by Respondent was blindness and its incumbent, incalculable damages, including, but not limited to, loss of independence, loss of mobility, and loss of enjoyment of life. Respondent admitted that, if not for the procedure, the three patients would likely not have been blind.2
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Nursing enter a final order finding that Respondent has violated sections 456.072(1)(o) and 456.072(1)(m) and revoking Respondent’s license to practice as an advanced practice registered nurse. DONE AND ENTERED this 3rd day of May, 2021, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of May, 2021. COPIES FURNISHED: Dirlie Anna McDonald, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Nicole M. DiBartolomeo, Esquire Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Louise St. Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Dwight Oneal Slater, Esquire Cohn Slater, P.A. 3689 Coolidge Court, Unit 3 Tallahassee, Florida 32311 Joe Baker, Jr., Executive Director Board of Nursing Department of Health 4052 Bald Cypress Way, Bin C-02 Tallahassee, Florida 32399 Deborah McKeen, BS, CD-LPN Board of Nursing Department of Health 4052 Bald Cypress Way, Bin D-02 Tallahassee, Florida 32399
Findings Of Fact Respondent is a licensed chiropractor in the State of Florida and was so licensed at the time of the alleged violations. He holds License No 2167 issued by the State Board of Chiropractic Examiners. On December 24, 1975, pursuant to a request of Randy Spector for a blood test, Respondent extracted a blood sample from Spector. At this time, Respondent informed Spector that he would send the blood sample to MET-PATH laboratories for testing and that the results would be back in approximately a week or ten days. A few days later Spector visited Respondent's office and was informed by him that the tests were fine and that he was in good health, but he did not have the results back from the laboratory. Respondent's wife, who was present, told Spector that the laboratories do not always send the test back unless they are asked for or unless something was wrong. This sounded like "double talk" to Spector and he asked Respondent for the test results. Respondent said that he would call the lab on the phone and obtain the results. On January 2, 1976, Spector again visited Respondent's office and was provided the report of blood analysis. Respondent explained some of the entries on the report and after so doing, Spector asked him to sign the report. Respondent did so. Thereupon Spector gave him a check for $15.00 in payment for the test and was provided a receipt. (Testimony of Spector, Petitioner's Exhibits 1,2 & 3) Spector was now convinced that the analysis of his blood had not been made by MET-PATH laboratories and therefore called that company several times during the next week or so. Each time he was informed by that concern that they had not received any of his blood for testing from Respondent. On January 5, 1976, Spector's legal counsel wrote a letter to Respondent advising him that Spector believed that the test results were fabricated and asserted a claim for malpractice and fraud. Respondent's counsel responded by letter of January 19 denying the allegations and stating that "if there was any error, it was simply an error in transposition of any test results and there was no resulting damage of any nature whatsoever to your client". (Testimony of Spector, Respondent's Exhibits 1 & 2). Spector contacted Dr. George Fica, a chiropractor who had been treating him and his wife. He told him of his complaint against Respondent and indicated that the matter was going "to be blown sky high" and that the press would be involved. However, Spector told Fica that if Respondent apologized, he would drop the matter. He showed Fica the blood test results and Fica told him that they were in normal limits but that some of the tests would have required the use of a laboratory. Fica talked to the Respondent about Spector's complaints and his claim that MET-PATH Laboratories had not done the work. Respondent stated that he had done it with a machine in his office. Fica then questioned him about certain tests such as triglycerides, which required laboratory analysis. Respondent then informed him that he didn't do the work in his office, but that he was using many labs for blood work and that his secretary had typed the wrong information on Spector's report. (Testimony of Fica) About January 12th or 13th, Spector went to Respondent's office and told him that the matter had gotten out of hand and that he wanted to straighten it out. Spector checked Respondent's tape recorder to make sure it was not running and also looked up and down the hallway outside his office and then closed the door. During the course of the conversation, Respondent apologized for not sending Spector's blood sample to MET-PATH and told him that he had run the tests in his own office and that they had been transposed in error. Spector told Respondent it would cost him a lot of money to go to court and indicated that the matter should be settled. (Testimony of Spector; Respondent) It was stipulated that Respondent had not sent Spector's blood sample to any laboratory for analysis. Respondent testified that he had originally planned to send Spector's blood to MET-PATH but due to a previous fire that destroyed much of his office, he had no usable mailing cartons for this purpose. Therefore, he did those tests that he could perform on a machine in his office. A number of the tests could not be done on the machine and he was unaware that his secretary had typed entries for such tests on the report given to Spector. Respondent speculated that the secretary must have mistakenly used figures from another patient's blood test when preparing the report. This explanation is not deemed credible in view of Respondent's contradictory statements in this regard to Spector and Fica as set forth in the foregoing findings. The laboratory cost for preparing a blood analysis is approximately $10.00. (Testimony of Resp., Pet.'s Exh. 4) Respondent has been a chiropractor for approximately 13 years and enjoys an excellent reputation for competence in his field. An associate, who has been in his office for the past several months, has never observed him engage in an unethical practice. (Testimony of Respondent, Fica, Gordon)
Recommendation That the Florida Board of Chiropractic Examiners issue a reprimand to Respondent, R.H. Grant, for violation of Section 460.13(3)(h), Florida Statutes. DONE and ENTERED this 25th day of October, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Ronald C. LaFace, Esquire Post Office Box 1752 Tallahassee, Florida Charles A. Sullivan 1245 20th Street Post Office Box 3 Vero Beach, Florida 32960
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.
The Issue The issues to be resolved in this proceeding concern whether disciplinary action should be taken against the Respondent's license to practice medicine based on allegations that the Respondent violated the standard of care, specifically Subsection 458.331(1)(q) and (t), Florida Statutes, by allegedly inappropriately or excessively prescribing legend drugs and by failing to practice medicine with that level of care, skill and treatment recognized as acceptable by reasonably prudent physicians under similar conditions and circumstances. It must also be determined, if any of the alleged violations are proven, what, if any, penalty is warranted.
Findings Of Fact The Petitioner is an agency of the State of Florida charged, in pertinent part, with regulating the entry into practice and the regulation of practice of licensed physicians in the State of Florida. That statutory authority includes ascertaining whether physicians practice in accordance with the appropriate standard of care, including determinations of whether and to what degree disciplinary sanctions should be imposed, by standard set forth in Subsection 458.331, Florida Statutes. The Respondent at all times material hereto has been a licensed physician in the State of Florida. He holds license No. ME0010390. The Respondent is board-certified in surgery and thoracic surgery and has been most recently employed by the Department of Corrections (DOC) as a physician and Assistant Medical Director at the NFRC. This is a DOC facility in Lake Butler, Florida, which medically screens and processes prison inmates before they are transferred to a permanent prison location. It also provides, through a 130-bed hospital, care and treatment for inmates around the state for non-emergency conditions. The NFRC hospital does not have an intensive care unit but the DOC has a contract to provide care for emergency or complicated medical cases with the Memorial Medical Center in Jacksonville for the performance of any complex or emergency surgeries. The DOC contracted with a private company to provide surgical facilities at the NFRC for minor surgery. This includes hernia repairs and liver biopsies. The private facility maintains a "mobile surgical unit" located a few hundred yards from the NFRC hospital. This unit is not designed for serious post-surgical complications. In order to perform any surgery at this mobile surgical unit an independently-contracted surgical consultant must request the DOC to approve the surgery. Then the requested surgery must be reviewed and approved through a utilization management process. Finally, the recommended surgery is reviewed by Dr. Azcuy, the Medical Director of NFRC. Dr. Azcuy has veto power on any surgery performed at the mobile surgical unit. Once he approves a surgery, an independently contracted surgeon performs the surgery at the mobile surgical unit. After surgery is completed at the unit the patient is then taken back to the NFRC hospital where DOC employees provide follow-up care and treatment. The Respondent, as Assistant Medical Director of the NFRC hospital, is such a DOC medical employee. The Respondent, Dr. Vontz, was born May 31, 1930, in Germany. He grew up and was educated in pre-war, war-time and post-war, occupied Germany. He received his medical education at Universities in Hamburg and Freiburg, Germany, as well as at the University of Florida and the University of Michigan in the United States. He has been an Assistant Medical Professor at the University of Florida/Shands Medical Center and is board- certified in surgery and in thoracic surgery. He became a United States citizen in 1961 and located his practice primarily in Jacksonville, Florida. He practiced thoracic surgery in Jacksonville, Florida, from the early 1960's until his initial retirement on December 31, 1993. He was primarily responsible for organizing and initiating the first cardiac surgery unit and surgical team in Jacksonville, Florida. His practice involved any type of surgical intervention in the chest cavity including heart, lungs, major vessels, diaphragm, as well as open-heart surgery. He performed open-heart surgery in Jacksonville from 1965 to 1993. After initially retiring from the performance of heart surgery in 1993, Dr. Vontz was unsatisfied with retirement and returned to work as the medical director of Methodist Medical Center in Jacksonville. As Medical Director he supervised physicians and observed and monitored their manner and means of practice. He also became medical director of Champion Health Care, a Health Maintenance Organization (HMO). When Champion Health Care closed its operations in Jacksonville due to financial circumstances in 1996, Dr. Vontz went to work as an employed physician at NFRC as Senior Physician and Assistant Medical Director. He was thus an employee of the Department of Corrections at that point. Dr. Vontz stays current in knowledge of medicine and proper medical practice by participating in continuing medical education. He has never before been the object of a complaint concerning his medical practice and his rendition of medical care for patients. The Surgical Procedures A liver biopsy is a sampling of the tissue of the liver. A percutaneous liver biopsy can be performed with a closed abdomen, involving no incision. It can be done "blindly" meaning without a CT scan or laproscopic instrument for guidance of the insertion and placement of the biopsy needle device. The standard of care requires a surgeon to continue making passes or inserting a needle until an appropriate sample in obtained. The requirement of making three passes of the needle to obtain an adequate sample is probably within the standard of care. The making of four passes, as was the case with this patient, T.C., may or may not be within the standard of care. The standard of care does not specifically determine the number of passes permitted or required. The procedure for a percutaneous liver biopsy involves the use of a "trecut needle." That is a needle with a hollow metal sheath designed to allow the insertion of the needle device into the liver with the hollow sheath taking a core sample of the liver tissue, which is then withdrawn for laboratory analysis. The appropriate standard of care for such a liver biopsy, done blindly, is for the patient to be in a sitting position. This allows gravity to force the organs, including the colon and intestine in the area of the liver, to fall away from the vicinity of the liver somewhat so as to avoid some of the risk of puncturing a hollow intestine or "hollow viscous" organ with the needle. The standard of care would also require that the procedure be done under a local anesthetic so that the patient remains conscious and can demonstrate to the surgeon performing the procedure through reaction to excessive pain, etc., when the procedure may have gone awry through improper placement of the needle device. The two surgical procedures performed on patient T.C. were the percutaneous liver biopsy, with a trecut needle, and a left, inguinal hernia repair. These procedures were performed on the same surgical occasion and were performed under a general, endotracheal anesthesia with the patient on the operating table in a supine position for both procedures. Patient T.C. was a 33-year-old male. He had a left, inguinal hernia which required repair and the attendant liver biopsy procedure was performed on him because he suffered from "Hepititis C." The procedures were performed on April 14, 1998, at 8:30 a.m. by Dr. Zomorodian, a board-certified surgeon and independent contractor for the DOC. The liver biopsy in the upper quadrant required four "runs" or "passes" in order to obtain a specimen. A "gooey substance" was obtained in the trecut biopsy needle. On April 14, 1998, at approximately 9:30 a.m., right after the surgical procedures were performed, Dr. Zomorodian wrote a hand-written operative note reading in pertinent part as follows: "percutaneous biopsy of liver done first the patient tolerated the procedures well- to recovery room in stable condition." This hand-written operative note was the only report of any kind available to the Respondent from Dr. Zomorodian, the operating surgeon, concerning patient T.C. On that same day however, Dr. Zomorodian also a dictated a more detailed operative report. The operative report indicated that a "gooey substance" was obtained during the liver biopsy. Operative reports, in the normal course of business, have to be typed and filed by the administrative staff and are not generally available for approximately three days. That was the case in the instant situation and the operative report was not available at any pertinent time to the case at hand for Dr. Vontz's benefit. Although the extraction of a "gooey substance" does not automatically mean that a bowel or hollow viscous organ has been perforated by the biopsy needle, for instance it could possibly have been a substance obtained from the diseased portion of a patient's liver, it is a strong indication that a hollow viscous organ, for instance the colon, has been penetrated by the needle. The presence of the gooey substance in the biopsy needle specimen should have placed T.C.'s surgeon, Dr. Zomorodian, on notice that a complication had occurred during the liver biopsy, including the likelihood of perforation of a hollow viscous organ such as the colon or other intestinal portion. It is significant that Dr. Zomorodian, after patient T.C.'s death, asked the hospital staff to change his dictated and typed operative note to remove reference to the "gooey substance". The DOC's hospital staff refused to do so. The operative procedures were finished by 9:23 a.m. on April 14, 1998. The patient was removed to the recovery room of the mobile surgical unit and at 9:43 a.m. was given 50 milligrams of Demerol intravenously for pain. At 10:30 a.m. he was moved from the surgical unit to the second floor of the NFRC hospital. Dr. Zomorodian expected him to have pain subsequent to the liver biopsy and hernia repair. At 9:30 a.m. that morning he ordered Demerol in the amount of 75 milligrams with Phenergan intramuscularly on an as-needed basis for pain and also ordered Tylenol No. 3, one or two tablets every three hours for pain. Tylenol No. 3 contains codeine. This analgesic pain medication order by Dr. Zomorodian, according to normal written protocol for the hospital, was to be in effect for three days. Post-Operative Care On April 14, 1998, during the course of the day after surgery, T.C. complained of pain. He was given Demerol and Phenergan (25 milligrams) at 11:00 a.m., 2:30 p.m., and 10:00 p.m., in accordance with Dr. Zomorodian's standard medication order and protocol. Phenergan is a drug used to accentuate the effect of Demerol. T.C. at age 14 began to use marijuana and to drink alcoholic beverages at the age of 16. By age 20 he had started cocaine use. As shown by Dr. Lynn's testimony a patient with a drug history such as this is more resistant to pain medications and requires more of them to alleviate pain than someone who has not used such drugs on a frequent and recurring basis. T.C., in the recovery room, was given 50 milligrams of Demerol intravenously. Dr. Lynn established that this medication approximately an hour after surgery would be abnormal for a hernia repair and an uneventful liver biopsy, if such were the case, especially after receiving 20 cc's of 0.5% marcaine containing epinephrine at the end of the operation in addition to the general anesthetic which has it own pain reliever in it. The installation of the marcaine with the epinephrine should have alleviated any immediate wound pain associated with the surgical procedures. During the afternoon of April 14, 1998, the Respondent was asked by the charge nurse to examine T.C. because of her suspicion that T.C. was complaining of pain merely as a ruse to obtain drugs. The Respondent assessed the patient and determined that his complaints of pain were genuine and so he continued the medication order according to Dr. Zomorodian's standing order. Dr. Vontz had no reason to believe that the patient was having any complication or acute distress at that point and therefore went home at his usual time of approximately 4:00 p.m. His normal working hours were 7:00 a.m. to 4:00 p.m. Other senior physicians and emergency room physicians were present or on-call during evening and early morning hours under the standard operating procedure of the hospital. Dr. Vontz returned to the hospital at approximately 6:30 to 7:00 a.m. on the morning of April 15, 1998, and saw the patient at 7:15 a.m. The pain medication had been continued according to Dr. Zomorodian's order with the last Demerol injection, with Phenergan, occurring at approximately 4:05 a.m. that morning. The patient had not urinated during the day on April 14 until approximately 5:00 p.m. when he voided 300 cc's of urine with pain. When the Respondent examined the patient at 7:15 a.m. on April 15 he found and noted in his record: "abdomen tightly distended ?? rebound. Will treat as acute abdomen and follow closely." An abdomen described as "tightly distended" means that the abdomen is tense, firm and swollen. "Rebound" means that the physician has placed pressure on the abdomen with his fingers and upon release of the pressure the patient has pain. "Acute abdomen" is severe abdominal pain that could occur for a number of reasons. It could be a potentially catastrophic event needing immediate surgical intervention (abdominal exploratory surgery). It may be caused by a disease process secondary to a perforated bowel or ruptured appendix for which immediate surgery is indicated, or it may result from conditions such as a subscapsular hematoma (blood under the membrane capsule enclosing the liver), an ileous or blockage of an intestine, or may be pain resulting from a "shutdown" or failure of bowel function. It is not uncommon when abdominal surgery, even a hernia repair, has occurred that for a certain period of time, due to possible contact with the bowel during surgery, that the bowel will simply cease to function temporarily or have a halt to the peristalic movement of the bowel. Dr. Vontz thus made a decision to treat T.C. condition as an acute abdomen and then follow the patient closely to try and diagnose whether the abdominal distress was caused by a catastrophic event such as a perforated bowel requiring surgical intervention (surgically acute abdomen) or whether some other non-infectious disease process or condition was occurring causing the abdominal pain in which case it would be termed and diagnosed as a "medically acute abdomen," not necessarily requiring surgical intervention. Thus the standard of care required that the Respondent attempt to determine the underlying cause of the acute abdomen which he did by ordering a number of diagnostic tests or procedures. He also placed the patient at "NPO," meaning no nourishment or liquids by mouth. He ordered fluids administered intravenously at the rate of 150 cc's per hour, ordered an upright and "flat plate" X-ray of the abdomen and chest and additionally ordered a "stat CBC" meaning an immediate complete blood count. The stat blood count was designed to show whether white blood cell counts were elevated, which would indicate that an infectious process was going on which would require surgical exploration to determine if the colon and/or another organ had been penetrated, required repair and emergency treatment for infection. At 11:10 a.m. on the morning of April 15, Dr. Vontz also ordered a catheterization for T.C. because of the previously noted problem of low urine output. At 12:15 p.m. Dr. Vontz met with the radiologist, Dr. V. M. Saenz, and evaluated the chest and abdominal X-rays. It was their joint opinion that the chest X-ray was not remarkable. The abdominal X-ray did not show any air or fluid levels which the Respondent would expect if a perforated bowel had occurred. The presence of air (gas) or fluid would indicate the perforation of a hollow viscous organ, such as the colon. The X-ray did show a large amount of feces in the colon however. Because of the history of the recent liver biopsy the possibility of a subcapsular hematoma of the liver was considered. A subcapsular hematoma is the accumulation of blood and fluid within the membrane capsule surrounding the liver and could occur due to bleeding from the penetration of the liver by the biopsy needle. In order to investigate that possibility a CT scan of the abdomen was ordered by the Respondent and performed. The CT scan was requested on an emergency basis and performed at 1:47 p.m. on April 15. A CT scan images a patient in "slices" giving a three dimensional picture of the area in question so that the patient can be observed for any abnormalities. Drs. Vontz and Saenz interpreted the CT scan of the abdomen as follows: . . . a crescent-shaped, hypodense collection of fluid is demonstrated along the supra lateral portion of the liver. Although this could correspond to a liquefied subcapsular hematoma taking into consideration that the liver biopsy was performed yesterday . . . would expect this to be of higher density . . . there are also several fluid filled distended loops of small bowel in the left upper quadrant which most probably correspond to jejunum. Because, in effect, the collection of fluid referenced in this quoted note is not of sufficient density to be recognized as a collection of blood along the supra lateral portion of the liver, it was determined that this was serum or other fluid. Thus on April 15th at 4:00 p.m. Dr. Vontz ruled out a subcapsular hemorrhage, thus ruling out both blood and "free air" in the abdomen. In cases where the colon or other hollow viscous organ is penetrated the presence of "free air" or gas is noted in approximately 75% of the cases. Thus the lack of it is indicative, although not conclusive, of the lack of a perforation of a hollow viscous organ. When the Respondent saw the patient at 7:15 on the morning of April 15th and ordered the stat CBC the blood count was then made, some 22 to 24 hours post-surgery. The blood count showed a white blood cell count of 4.6 with the upper end of the normal range being 12.3. Thus the white blood cell count, a marker for infection, appeared entirely normal. The neutrophil portion of the blood count revealed a slightly elevated reading or a slight abnormality. Neutrophils are immature white blood cells which, if abnormally high, can indicate the presence of infection. Because they were only slightly elevated that did not really indicate infection to the Respondent since they can normally occur after surgery. A slight elevation can normally be attributed to atelectasis, a condition associated with the fact that the patient had had a general anesthesia and therefore somewhat decreased lung function as well as an abdominal operation which subsequently resulted in severe pain in the abdomen, which can cause a slight elevation in the neutrophil count. The normal white blood cell count, with only a slight increase in neutrophil reading and the absence of any significant elevated temperature on April 15th understandably resulted in the Respondent's not concluding that any infectious process was going on at that point. This is certainly an abnormal presentation of symptoms by a patient, who upon autopsy, was proven to have had a large, two centimeter perforation of the colon, with a massive peritonitis infection. In such a patient it is highly unusual for more blatant signs of an infectious process, including a significantly elevated, white blood cell count, not to have occurred 24 hours after the surgical procedure which resulted in the perforation. On April 15th at 4:00 p.m., Dr. Vontz ruled out a subcapsular hematoma or hemorrhage and ruled out blood and free air being present in the abdomen. The CT scan however, did show the presence of a fluid collection in the vicinity of the liver, as found above. Also on April 15th at 5:00 p.m., Dr. Vontz ordered the placement of nasogastric tube in the patient in order to prevent his swallowing air and causing further distention of the alimentary tract. At 7:00 p.m. that evening the patient removed the nasogastric tube on his own and refused to have it replaced. He was uncooperative with care throughout that shift even when the nurse explained the necessity of his treatment. On the morning of April 15th at 6:30 a.m., just before the Respondent saw him, T.C.'s vital signs were within normal limits. At 1:25 p.m. that day, some 29 hours after the liver biopsy, his vital signs were still within normal limits. His blood pressure was 134/88, his temperature was 97.4, his heart rate was 110, and his respiratory rate was 20 at 1:25 on April 15th. Thus he was still not demonstrating an infectious process some 29 hours after the surgical procedure involved. On April 15, 1998, at approximately 5:00 p.m. the patient's abdomen remained distended, without audible bowel sounds and he continued to complain of pain. His urine was dark and concentrated. Once again, in accordance with Dr. Zomorodian's orders, was given Demerol at approximately 5:00 p.m. on April 15th. On April 16, at approximately 6:25 a.m., T.C. was restless and continued to complain of severe pain, he was again given Demerol. At 6:22 a.m. on the morning of April 16th approximately 46 hours subsequent to the liver biopsy, his vital signs were still within normal limits. At 8:00 a.m. that morning Dr. Vontz ordered that he be maintained on NPO status; that intravenous fluids be decreased to 100 cc's per hours and that he be given a dulcolax suppository because of his bowel status. T.C., as a result, had a large emptying of the bowel, which made him feel grossly better. During his interview with Dr. Vontz at approximately noon that day he was able to stand at his bedside and sit by his bedside and converse with Dr. Vontz. At 8:45 that morning of April 16th, Dr. Vontz had ordered a "stat Chem 20 test." The "Chem 20" revealed hemoconcentration or concentration of the blood, which indicated dehydration. At 12:40 p.m. on April 16th, Dr. Vontz ordered a foley catheter inserted in the patient's bladder and ordered another Chem 20 test of his blood for April 17th. He also ordered clear liquids for T.C. since he seemed to be feeling better after the bowel movement and the Respondent felt he could take clear liquids by mouth. His urine output remained low and at 1:00 p.m. on April 16th, Dr. Vontz ordered a urine culture and sensitivity study. The urine culture was ordered by the respondent by telephone upon a nurse contacting him because he was at an in-service training seminar some half-mile away from the patients hospital floor at that time. By 1:00 p.m. the patient was very restless, becoming somewhat confused and was tachycardic, which means increased heart rate. His heart rate was as high as 159 beats per minute. He had a respiratory rate of 28 and a blood pressure of 94/64 in the afternoon of the 16th. In addition to ordering the urine culture, an electrocardiogram was performed on the patient, ordered approximately at 1:00 p.m., which revealed abnormal tachycardia. Dr. Vontz listened to T.C.'s bowel sounds on both the morning of the 15th and the morning of the 16th. His bowel sounds were returning to normal on the morning of the 16th and after receiving the suppository T.C. had a bowel movement, which gave the Respondent the impression that the patient was improving. Clinically, he exhibited no nausea, vomiting, or any sign of bowel obstruction. The low urine output and the tachycardic condition along with the elevated respiratory rate and depressed blood pressure after 1:00 p.m. on the 16th showed that the patient, however was becoming more critically ill. In retrospect it is apparent that he was in septic shock. Dr. Vontz last visited the patient at 4:30 p.m. on the 16th. He determined that he should be transported to Memorial Hospital for more aggressive care, including surgical exploration of the abdomen to attempt to determine the cause of his condition. The Respondent elected however, because of the lateness in the day to avoid confusion and discontinuity in his care and treatment by having him transported early the following morning. Dr. Vontz felt there would be less likelihood of delay or interruption in the level of care for the patient than if he arrived at the critical care hospital in the middle of the evening. After seeing the patient at approximately 4:30 p.m., Dr. Vontz went home but remained in telephone communication with the hospital, medical staff and the registered nurse on duty. At approximately 8:15 p.m. on the 16th Katherine Kravitz, R.N., called Dr. Vontz informing him that T.C. had "spiked a fever," measured at the axcilla (armpit) at 103 degrees. She also advised the Respondent that the Chem 20 test had been returned and demonstrated a BUN of 55. Dr. Vontz determined that this demonstrated hemoconcentration, indicating dehydration. Dr. Vontz therefore increased his fluids intravenously to 150 cc's per hour. He also ordered Lasix to be provided, as a "one-shot" medication, because he was concerned about T.C.'s kidney function being substandard, in view of the rising BUN reading and because the fluid was being increased to 150 cc's per hour. He wanted to be sure that T.C. was able to void sufficient urine to accommodate the increase in intravenous fluid. He learned that T.C. had adequate kidney function to accommodate the increase in IV fluid administration. He also ordered at this time that T.C. be given Fortaz at 1 gram every 8 hours intravenously. Fortaz is an antibiotic specifically designed to attack abdominal infectious processes especially attributable to escherichia coli (e-coli) contamination in the abdomen. Dr. Vontz was of the belief that the sudden temperature elevation indicated that there had been a sudden burst of infection. Up to the point of the telephone call at 8:15 the evening of the 16th T.C.'s temperatures had not been significantly elevated, although other of his vital signs on the afternoon of the 16th had indicated abnormality, involving low blood pressure, elevated respiratory rate and tachycardia, as found above. Dr. Vontz called nurse Kravitz at 11:00 p.m. on April 16th and learned that T.C.'s temperature was down from 103 to 100.6 degrees. This led him to believe that the antibiotic administration and the IV fluid therapy was improving the patient. Earlier on April 16th at approximately 4:30 p.m. in response to the patient's restlessness and continued severe pain the Respondent had ordered Ativan and Morphine, as well as placing him in restraints and a posey vest. The Ativan and restraints were ordered because of his restlessness and anxiety. The Morphine is a narcotic stronger than Demerol in its analgesic properties. Patient T.C. at 6:00 p.m. that day was still confused and his urine was dark amber in color, indicating dehydration. Throughout the late night of April 16, 1998, the nursing notes indicated that the patient was moaning and groaning without verbal response and was no longer fighting against his restraints. In retrospect it is clear that he was dying. The information given Dr. Vontz when he called the nurse to check on the patient at approximately 11:00 p.m. on April 16th, and learned that the patient's temperature was down to 100.6 and that his other vital signs were returning to normal levels, indicated to him that the antibiotic and intravenous fluid therapy was helping the patient to improve. Curiously, the hospital records indicate that on the early morning of April 17th at 1:15 a.m., the patient's temperature was 100.6, his pulse rate was down to 80, and his respiratory rate was 24 with blood pressure at 100/60, indicating vital signs returning to normal levels. At 3:45 a.m. on April 17th however, T.C. was found to be without vital signs and was shortly thereafter pronounced dead. Thus, within 55 hours of the attempted liver biopsy by Dr. Zomorodian, T.C. was dead. Upon autopsy, it was found that he had a two centimeter diameter hole in his colon which caused significant release of e-coli bacteria into T.C.'s abdominal cavity, resulting in massive, acute bacterial peritonitis. Dr. Vontz arose at his home at approximately 4:00 a.m. on the morning of April 17th to go to the hospital to arrange for the patient's transfer to the acute facility at Memorial Medical Center. He was shocked to arrive and find that the patient had died. The patient had been seen on the night of the 16th and early morning of the 17th by the emergency room physician on duty, Dr. Edwards. Emergency room physicians are involved in continuing the treatment of in-house patients at NFRC when attending physicians are off-duty. Analysis of Responsibility The medical examiner, Dr. Hamilton, who performed the autopsy on T.C. found the two centimeter hole in the proximal transverse colon. The proximal transverse colon is on the right side of T.C.'s body adjacent to the liver. This clearly demonstrated that the attempted liver biopsy by Dr. Zomorodian caused the perforation of the colon in the vicinity of the liver. The patient had been given 50 milligrams of intravenous Demerol at 9:43 a.m. by Dr. Zomorodian's order. This need for medication only approximately an hour after surgery would be abnormal for a hernia repair and an uneventful liver biopsy. Less than an hour after receiving this Demerol T.C. was moved out of the surgical unit recovery room and taken to "two West" in the NFRC hospital. When transferred to the NFRC hospital it would have been certainly appropriate for Dr. Zomorodian to admonish, in his post-operative note, as testified to by Dr. Lynn, that "we may have caused this patient some problems, we did four sticks, we came back with a gooey substance, watch this patient carefully." Instead Dr. Zomorodian only made a cryptic post- operative note to the effect that the liver biopsy was done, with no more description than the fact that it was done. Although he dictated and had typed a more elaborate post-operative note that mentioned the gooey substance, this was not available at any time to Dr. Vontz during his care of the patient. Moreover, Dr. Zomorodian attempted to have the reference to the gooey substance edited out of his post-operative note, which the hospital staff quite correctly refused to do. The surgeon performing the surgical procedures, under the protocol of the American College of Surgeons and the NFRC protocol should not delegate post- operative care to someone else, under normal circumstances. If that surgeon cannot be involved in the post-operative care, he must communicate in a very clear and unequivocal fashion, to one who has been delegated the post-operative care, all information concerning the surgical procedure and the care of the patient while the patient was under his care and treatment, which Dr. Zomorodian did not do. It was thus incumbent upon Dr. Zomorodian to make certain that there was effective follow-up care for his patient but there is nothing in the record to indicate that Dr. Zomorodian ever called anyone associated with the NFRC hospital, post-operatively, to check on his patient or to provide them information concerning the patient. Be that as it may, the Respondent, in the absence of any information from Dr. Zomorodian, in following the appropriate standard of care, should have contacted Dr. Zomorodian as the surgeon of record during the course of the care of T.C., and he failed to do so. Dr. Vontz also departed from the appropriate standard of care in several other particulars. First, he failed to adequately recognize and act on the knowledge produced by the CT scan that there was a fluid collection, which did not appear to be blood, in the vicinity of the liver. This clue, learned by the Respondent and the radiologist at approximately 4:00 p.m. on April 15th would seem to indicate that aggressive, surgical intervention early in this patient's course of care was in order. Moreover, in the face of the patient's continuing symptoms, and even though the initial complete blood count did not show an elevated white cell count, and thus did not seem to indicate infection, a later CBC should have been ordered on April 15th or even April 16th; particularly on the morning of April 16th in a continuing effort to rule out an infectious process beginning in the patient. This was not done after the initial CBC was obtained on the morning of April 15th. Additionally, compliance with an appropriate standard of care would dictate that by the early afternoon of April 16th, with the presence of tachycardia, depressed blood pressure, elevated respiratory rate, and the continuing severe abdominal pain, that the Respondent should have transferred the patient to Memorial Medical Center that afternoon for more aggressive treatment. The decision to transfer him did not occur until early in the evening of the 16th and then the Respondent, for the reasons found above, decided not to effect the actual transfer until early the following morning, by which time it was, of course, too late. Although the Respondent was not clearly alerted to an infectious process until the high temperature which occurred after 8:00 p.m. on the night of the 16th, the other critical symptoms earlier in that afternoon should have compelled him to have the patient transferred to the acute care facility. Indeed, if a CBC had been ordered to look at white blood cell count earlier on the 16th or even on the afternoon of the 15th the progress of the infection might have been detected even though it was not resulting in any significant increase in body temperature. Thus, in these particulars, the Respondent must be found to have violated the appropriate standard of care as well as in the fact that during the day on April 16th he did not make progress notes outlining his treatment plan. That is not a finding that he had no treatment plan, however. Taking a more prophylactic, cautious view of the results of the CT scan and the ordering of an additional CBC on late April 15th or early on April 16th might have pointed him toward a finding of the existence of a surgical problem rather than a medically acute abdomen problem. This would have impelled him to effect aggressive surgical intervention earlier, with the possibility of saving the patient. In fairness to Dr. Vontz it should be pointed out that infectious peritonitis is a rapid and devastating illness, but death within the third day of contamination is a bit rapid and unusual. Moreover, traditionally a patient experiencing one or more perforations of the colon usually evolves a clearly discernable infectious process around the 24th hour after the perforation occurs. The medications ordered and administered by the surgeon, Dr. Zomorodian, could have masked some symptoms and led the later care-giver astray as to the evolving signs and symptoms of a perforated viscous for a time. T.C.'s infectious process presented in an unusual manner. A typical patient would demonstrate severe illness, with nausea, vomiting, and severe pain. In the vast majority of cases he would exhibit free air or gas under the diaphragm and would have an elevated white blood cell count fairly early, with associated elevated body temperature or fever and chills. Dr. Vontz indeed considered the issue of a perforated bowel and performed the above-found tests in an effort to find evidence of it. He believed the test results, including the complete blood cell count did not produce evidence to support the existence of a perforated bowel. In fact, however, the abnormality on the CT scan involving hypodense fluid in the vicinity of the liver should have alerted him to that potential and he should have ordered an updated complete blood cell count which might have told him of the advancing infectious process at an early enough time to have saved the patient. In fact, the evidence demonstrates that the time period between 12 hours and 48 hours after such a perforation and inoculation with e-coli bacteria occurs is critical and that after 48 hours without aggressive, surgical intervention it is improbable that such a patient can be saved. A more aggressive approach to the result of the CT scan abnormality, an updated complete blood cell count and contact with the surgeon involved would have been a more appropriate standard of care and might have compelled Dr. Vontz to have acted more quickly in having the patient transported for more critical intensive care.
Recommendation Accordingly, having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses and the pleadings and arguments of the parties it is, therefore, RECOMMENDED: That a final order be entered by the Board of Medicine finding the Respondent guilty of violating Subsection 458.331(1)(t), Florida Statutes, in the above-found and concluded manner, and not guilty of violating Subsection 458.331(1)(q), Florida Statutes, and that, as a penalty therefor the Respondent shall: Complete 50 hours of continuing medical education in surgery; Complete the Florida Medical Association Quality Medical Records Course; Remain on a probationary status for a period of one year with the probationary term to require a review of 25% of the Respondent's medical records by a supervising physician approved by the Board of Medicine. DONE AND ENTERED this 19th day of July, 2000, in Tallahassee, Leon County, Florida. P. MICHAEL RUFF 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 19th day of July, 2000. COPIES FURNISHED: Kristy Johnson, Esquire Department of Health Post Office Box 14229 Tallahassee, Florida 32317-4229 Thomas R. Brown, Esquire Brown, Terrell, Hogan, Ellis, McClamma and Yegelwel, P.A. Blackstone Building, Eighth Floor 233 East Bay Street Jacksonville, Florida 32202 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Angela T. Hall, Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
Findings Of Fact The Petitioner, Shelly Gans, graduated from high school in June, 1973. She attended Broward Community College during terms 1 and 3 of the 1973-74 academic year, where she earned fifteen (15) credits. She does not have two years of academic study as required by Rule 10D-41.069(5). She then attended Sheridan Vocational Technical Center from February, 1974 to February, 1975. She was thereafter employed by Dr. Stephen Katzman from March, 1975 through August, 1979 as a technologist doing laboratory testing including phlebotomy. She was thereafter employed at Florida Medical Center as a technologist doing blood banking, hematology, chemistry and part time phlebotomy. Ms. Gans passed the October, 1983 proficiency examination for clinical laboratory technologists given by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control. After passing the U.S. Department of Health and Human Services examination, Ms. Gans was licensed as a clinical laboratory technician by the Department of Health and Rehabilitative Services Office of Licensure and Certification, Laboratory Personnel Licensure, through June 30, 1986. In October, 1984, Ms. Gans was examined by HRS for licensure as a clinical laboratory technologist in the specialties of clinical chemistry, hematology and immuno- hematology. She passed the immunohematology examination but failed the hematology and clinical chemistry examinations. She re-applied and took those examinations in April, 1985 when she passed the hematology examination but failed the chemistry examination a second time. Under Rule 10D- 41.071(9), Florida Administrative Code, Ms. Gans was required to take continuing education before she could re-apply to sit for the chemical chemistry examination a third time. Ms. Gans enrolled in Broward Community College in the second term of the 1985-1986 school year and took three hours in general chemistry. That course ended after January 1, 1986. She re-applied for examination as a technologist in the specialty of clinical chemistry on July 14, 1986. Her application for that examination was denied on August 14, 1986 because she did not have sixty (60) semesters of college credits which the Department believed was required under Section 10D-41.C69(5), Florida Administrative Code.
Recommendation It is RECOMMENDED that Shelly Gans be permitted to sit for the technologist examination in clinical chemistry when it is next given because she meets the requirements of Rule 10D- 41.069(6), as currently written and has taken retraining in clinical chemistry after she twice failed the examination, as is required by Rule 10D-41.071(9), Florid Administrative Code. DONE and ORDERED this 23rd day of July, 1987, in Tallahassee, Florida. WILIAM R. DORSEY, JR. 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 23rd day of July, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-3670 The following constitute my rulings on proposed findings of fact pursuant to Section 120.59(2), Florida Statutes, (1985). Rulings on Proposed Findings by Petitioner The proposals by the Petitioner are generally in the form of argument rather than proposed findings of fact. Relevant proposed factual findings have been made in the Recommended Order. Rulings on Proposed Findings by Respondent Covered in Finding of Fact 4. Covered in Finding of Fact 4. Covered in Finding of Fact 1. Rejected as an improper reading of Rule 10D-41.069(6). Rejected because the issue is not when notice of the rule was given, but what the rule says. Rejected as based on hearsay. Moreover, even if it was the intention of Centers of Disease Control that the Department of Health and Human Services examination not be a permanent means of credentialing in lieu of education and experience requirements, the Department of Health and Rehabilitative Services has not implemented that intent in the rule which it enacted. Rejected as unnecessary. That Ms. Gans' application was received after January 1, 1986 is covered in Finding of Fact 4. Rejected as unnecessary. COPIES FURNISHED: Michael O. Mathis Staff Attorney HRS Office of Licensure & Certification 2727 Mahan Drive Tallahassee, Florida 32308 Shelly Gans 4163 Southwest 67th Avenue Apartment 104C Davie, Florida 33314 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
The Issue This is an examination challenge proceeding in which the Petitioner asserts entitlement to a passing grade on a licensure examination.
Findings Of Fact The Petitioner, Allen Sledge, took the hematology technologist licensure examination in March 1999. In due course he was furnished a grade report which advised him that he had failed the exam. The grade report advised him that the minimum passing score was 350, and that he had achieved a score of 338. During the examination review requested by the Petitioner, he was not provided with the same examination booklet he had used during the examination. However, the contents of the examination booklet provided to him during the examination review were identical to the contents of the examination booklet provided to him when he took the examination. During the examination review process, the Petitioner was not allowed to make copies or notes regarding the content of any of the examination materials. Therefore, he had to write his challenges to the examination based on his memory of what he saw during the examination review process, without benefit of the exact language of the questions. The Petitioner's examination review was conducted in accordance with the provisions of statutes and rules that govern post-examination access to examination materials. There is only one version of the hematology technologist examination that was administered in March 1999. All candidates who took the examination on that date were provided with examination booklets that contained identical content. All candidates who took the hematology technologist examination in March 1999, were instructed to select the "best" answer for each question. With regard to the three challenged questions (Questions 35, 37, and 47), the Petitioner did not select the "best" answer to any of the three questions. Rather, the answers chosen by the Petitioner for each of the three challenged questions were incorrect choices. The subject matter of all of the challenged questions is appropriate for a hematology technologist licensure examination. All of the questions test for knowledge that should be known by a hematology technologist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED That a final order be issued dismissing the Petitioner's challenge to the examination, and concluding that the Petitioner failed the subject examination. DONE AND ENTERED this 18th day of January, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH 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 18th day of January, 2000.
