The Issue Whether Petitioner is entitled to receive a passing score on the clinical portion of the August 1999 optometry licensure examination.
Findings Of Fact Petitioner, Sandra Farhady (Farhady), took the Florida optometry licensure examination in August 1999. The examination is divided into four portions: laws and rules, pharmacology, clinical, and certification. Prior to the administration of the test, each examiner is given grading standards, which are the requirements that must be met by a candidate to successfully demonstrate a particular procedure. All examiners receive standardization training, during which the examiners are trained to apply grading standards consistently. Examiners are instructed to wear their best corrective lenses. Examiners are instructed to grade each applicant independently of each other and are not permitted to confer with each other concerning a candidate's score. If both examiners agree, the candidate receives no credit or full credit, depending on whether they considered the candidate to have properly performed the procedure requested. If they disagree, the candidate is given partial credit on that procedure. The clinical portion of the examination requires the applicant to perform a number of tasks while two examiners evaluate the procedures. The examiners observe the procedure through a viewing system known as a teaching tube which is attached to the optometrist's equipment used by the candidate. Only one teaching tube is used so each examiner views the procedure separately. The candidate may ask the first examiner to grade his view and hold the view for the second examiner without having to refocus, or the candidate may perform the procedure for each examiner. Farhady passed the laws and rules, pharmacology, and certification portions of the examination, but failed the clinical portion of the examination with a score of 69.1. The passing score for the clinical examination is 75.0. Farhady challenged the score that she received on question 11a of the clinical examination. The question dealt with a procedure called retinoscopy, and the Department conceded at final hearing that Farhady should have been given credit for her answer. The additional points associated with question 11a raised Farhady's final score to 70.125. Farhady challenged the score she received for questions 33a, 33b, 33c, and 34a of the clinical examination. The questions relate to a procedure known as applanation tonometry, which is used to check a patient for glaucoma by measuring the intraocular pressure. This portion of the examination was worth ten points. Applanation tonometry is performed using a tonometer. The tonometers used by all the candidates for the August 1999 examination were part of a Zeiss slit lamp, which is also called a Zeiss microscope. It is an apparatus commonly used by optometrists within the scope of their practice. Each of the tonometers had a large fixation device mounted on the left side of the microscope. On the day of the clinical portion of the examination, the tonometer used by Farhady was in working order. No other candidate made a complaint concerning the working condition of the tonometer. The tonometer used by Farhady was not altered before, during, or after Farhady's session. There are time limits for section two of the clinical portion of the examination, which includes the applanation tonometry procedure. The Candidate Information Booklet for the Optometry Examination, which is provided to all candidates prior to the examination, provides: To protect the patient and to evaluate clinical competency, we will put time limits on the amount of time you will have to attempt each of the Section Two procedures. Timing will start after you receive the initial instructions for each procedure from the examiners and will continue until completion of the procedure or until time expires. . . . The time limit for the applanation tonometry procedure is six minutes. Farahady was unable to complete the applanation tonometry within the time allowed during the examination. She could not make the probe of the tonometer contact the patient's eye. During the procedure she advised the examiners, "Something is up with the tonometer." Farhady filled in a Candidate Comment Form and stated the following: Unable to acquire a view on tonometry. Mires were clear but fluorescent pattern not correct. It appeared like ground glass. I reapplied NAFI, but same view was seen so no grading was possible & I ran out of time. One of the examiner's noted the following on the Examiner's Comment Form: Pt. Ran out of time on tonometry--was apparently unable to see mires. Mires did not 'Flouress' well but was easily visible. Light source was close to 90 [degrees] away which may have contributed. Tonometry was repeated by this examiner without instilling new NaFl successfully by brightening the light source & bringing it to 60 [degrees]. Farhady contends that the position of the fixation device prevented her from being able complete the tonometry procedure. The fixation device can be easily moved to one side, pushed back, or folded up. If the fixation device was hindering Farhady in bringing the tonometer probe in contact with the patient's eye, Farhady could have quickly and easily moved the device out of her way. The position of the fixation device is not a defect in the tonometer equipment, which would have prevented a candidate from successfully performing applanation tonometry. Item 33a was the evaluation of whether the illumination source was a proper angle of 40 to 60 degrees. Item 33b evaluated whether the mires were the proper width. Item 33c evaluated whether the mires alignment was correct. Item 34 was the evaluation of whether the candidate obtained an accurate reading of the intraocular pressure. Farhady did not have the proper angle, did not demonstrate whether the mires were the proper width, did not align the mires correctly, and did not obtain a reading of intraocular pressure. Farhady challenged the score she received for questions 25a, 26a, 27a, 28a, 30a, and 32a, in section two of the clinical examination. These questions relate to a procedure referred to as biomicroscopy of the fundus. The scores given by the examiners for these questions were not identical. Examiner 199 did not give Farhady any points for questions 25a, 26a, 27a, 28a, and 32a. Examiner 199 noted that Farhady did not establish the proper focus with respect to these procedures. While examiner 231 did give Farhady points for procedure 25a, examiner 231 noted that Farhady had achieved only a borderline focus. Both examiners noted poor focus with respect to question 32a and did not give Farhady credit for that question. Question 25a required proper focus of nerve head. Examiner 199 noted the following on the grade sheet with respect to question 25a: Could not get it in view in left ocular. Candidate even verbalized this. For questions 26a, 27a, and 28a, examiner 199 noted that Farhady had no focus. For question 32a, examiner 199 noted, "could not/would not maintain focus." Farhady challenges the scores she received for questions 2a and 4a on section one of the clinical examination. These questions relate to visual field testing. The candidate is shown a visual field and is asked questions pertaining to the visual field. When Farhady was shown the visual field, she immediately said out loud that it was a glaucomatous loss before the examiner could read the instructions to her. The examiner said, "no" and began to read the instructions. Farhady thought that the examiner meant that it was not a glaucomatous loss. The examiner manual advises the examiners to avoid any comments which the candidate could interpret as favorable or unfavorable. For question 2a, Farhady was asked to name the visual field defect. She stated that it was arcuate scotoma. The correct answer was superior arcuate scotoma. Credit is not given for partial answers. It is important that the candidate identify whether it is a superior or an inferior arcuate scotoma in order to establish the location of the lesion so that the correct diagnosis can be made. Whether the examiner said "no" is irrelevant to the answer which Farhady gave to question 2a because she did identify that it was an arcuate scotoma. For question 4a, Farhady was asked which disease would be most consistent with the visual field defect. Farhady answered supracellar craniopharyngioma, which is incorrect. In layman's terms, a supracellar craniopharyngioma is a tumor of the pituitary gland. A visual field of a tumor of the pituitary gland is a bitemporal configuration not an arcuate configuration, meaning that Farhady's answer did not correlate in any way with the visual field defect. It was improper for the examiner to have said "no" after Farhady responded that it was a glaucomatous loss. It could have been interpreted by a candidate, as it was by Farhady, that her response was incorrect. The examiner should have told Farhady to wait until the instructions were read. Question 4a was worth 1.5 points, giving Farhady a total percent score of 71.6, which is not a passing score.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Sandra D. Farhady did not pass the clinical portion of the August 1999 optometry licensure examination and dismissing her petition. DONE AND ENTERED this 13th day of April, 2000, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 13th day of April, 2000. COPIES FURNISHED: Joe Baker, Jr., Executive Director Board of Optometry Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Angela T. Hall, Esquire Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Sandra D. Farhady 6404 Wiley Street Hollywood, Florida 33023
The Issue The issue for consideration in this case is whether alleged statements attributed to the Board of Optometry were made by the Board, and if so, whether the statements constitute unpromulgated rules prohibited by Section 120.54(1)(a), Florida Statutes, (Supp. 1996).
Findings Of Fact The parties stipulated as a matter of fact that: The FOA is a not-for-profit Florida corporation whose membership is comprised of optometrists licensed under Chapter 463, Florida Statutes, to practice optometry in Florida. All FOA members are subject to and regulated by the Board of Optometry and its rules. The FOA has approximately 1,022 members. The Board of Optometry is the agency responsible for regulating the optometric practice of all FOA members. Board rules and agency statements of general applicability regulate the optometric practice of all FOA members. Individual members of the FOA, being subject to and regulated by the rules and policy of the Board of optometry, are persons whose substantial interests will be affected by the alleged agency statements and are thus substantially affected persons within the meaning of Section 120.56(1)(e), Florida Statutes (Supp. 1966). As all members of the FOA are subject to and regulated by Board rules and statements of general applicability, a substantial number of the FOA’s members would be substantially affected by the alleged statements. The objective of the FOA is to promote and protect the interests of the general public and licensed optometrists in ensuring the availability of high quality eye care at an affordable price. The FOA represents its members through the provision of education and training, and by participation in administrative proceedings, legislative activities, and court litigation. Petitioner, Brian Lloyd Weber, O.D., is an optometrist licensed and practicing in Florida. Petitioner, 29/49 Optical Inc., (29/49), is a corporation which operates optical establishments in Florida. The Board of Optometry is the state agency in Florida which licenses optometrists and regulates the practice of optometry in this state. On January 29, 1992, the Probable Cause Panel of the Board of Optometry determined there was probable cause to discipline the license of Dr. Weber because of an alleged violation of Section 463.014(1)(b), Florida Statutes, involving the corporate practice of optometry. Thereafter, on February 2, 1992, an Administrative Complaint was filed with the Board which alleged that Dr. Weber had violated the cited statute by engaging in the practice of optometry with a corporation not composed of other health care providers; by entering into a corporate arrangement which permitted an unlicensed person to practice optometry through Dr. Weber, in violation of Rule 21Q-3.008, (now Rule 59V-3.008, Florida Administrative Code); and by holding himself out to the public as available to render professional services in a manner which implies he is professionally associated with an entity which is not a licensed practitioner, also in violation of the Rule. The investigation conducted by the then Department of Professional Regulation, which led up to the action of the panel and the filing of the Administrative Complaint indicated that Dr. Weber owned 250 shares of stock in 29/49, along with an optician, Anthony Record, not licensed to provide optometry services, who also owns stock in the corporation. Allegedly, the corporation operated at five different locations, at one or more of which eye examinations were performed. It was also alleged that 29/49 had publicly advertised itself as an entity which provided complete eye examinations, and that Dr. Weber performed the eye examinations described in the advertisements. In fact, Dr. Weber is a director and officer of 29/49. He holds a 75% ownership share in the corporation. Both Dr. Weber and Mr. Record control the corporation and share the duties and profits of the operation. The firm provides optitianry services, as defined in Sections 484.002(3) and (7), Florida Statutes. Dr. Weber asserts that the operations of 29/49 are separate from the operations of his optometric practice, and claims that the Board’s direction to him to change the corporate structure of 29/49 so as to dissolve his partnership with a lay person is a continuation of what he claims is a long-standing policy of prohibiting the joint ownership of an optitianry between and optometrist and a lay person. Before a hearing was held on the Administrative Complaint, Dr. Weber and counsel for the Board entered into a stipulation which, if accepted by the Board, would have resolved the pending disciplinary action. The stipulation was presented to the Board at its July 8, 1993 meeting, at which time the Board voted to reject it and to propose a counter-stipulation. At that meeting, the Board did not enunciate any of the alleged agency statements at issue here nor did it take a position as to what Dr. Weber must do to rectify the practice situation to its satisfaction. Nonetheless, by Order dated September 9, 1993, the Board formally rejected the proposed stipulation and proposed its own stipulation. On September 12, 1996, Dr. Weber and the Agency’s counsel presented a second stipulation to the Board for settlement of the disciplinary matter, but again the Board voted to reject the stipulation and to offer its own second counter- stipulation. This counter-proposal called for Dr. Weber to change his corporate structure so that he no longer violated the statutory prohibition against practicing optometry with non- licensed individuals, and that he no longer practice with a lay person. This second counter-proposal by the Board did not enunciate any of the alleged agency statements at issue herein. This second counter-proposal was promulgated in an Order of the Board issued on October 15, 1996. Sections 463.014(1)(a)&(b), Florida Statutes, provide: No corporation, lay body, organization, or individual other than a licensed practitioner shall engage in the practice of optometry through the means of engaging the services, upon a salary, commission, or other means or inducement, of any person licensed to practice optometry in this state. Nothing in this section shall be deemed to prohibit the association of a licensed practitioner with a multidisciplinary group of licensed health care professionals, the primary objective of which is the diagnosis and treatment of the human body. No licensed practitioner shall engage in the practice of optometry with any corporation, organization, group or lay individual. This provision shall not prohibit licensed practitioners from employing, or from forming partnership or professional associations with, licensed practitioners licensed in this state or with other licensed health care professionals, the primary objective of whom is the diagnosis and treatment of the human body. Consistent therewith, the Board of Optometry has promulgated Rule 59V-3.008, Florida Administrative Code, which implements the provisions of the statute. Rule 59V-3.008, Florida Administrative Code, restates the intent of the legislature regarding the need for licensure of practitioners of optometry, defines a “licensed practitioner”, and thereafter outlines with particularity those actions which may and those which may not be carried on by licensed optometrists in Florida. The rule is quite clear in its definitions and leaves little room for misunderstanding regarding what constitutes the practice of optometry and optometric services; those individuals who must be licensed; what professional activities a licensed practitioner may perform and what activities constitute a violation of Section 463.014,Florida Statutes. Of specific relevance to the issues herein are: (15)(b) Entering into any agreement (whether written or oral) which allows, permits or facilitates an entity which itself is not a licensed practitioner to practice optometry, to offer optometric services to the public, or to control through any means whatever any aspect of the practice of optometry. Allowing, permitting, encouraging, forbearing, or condoning any advertisement including those placed in a newspaper, magazine, brochure, flier, telephone directory, or on television or radio, which implies or suggests that the licensed practitioner is professionally associated or affiliated with an entity which itself is not a licensed practitioner. Occupying or otherwise using professional office space in any manner which does not clearly and sufficiently indicate to the public that his/her practice of optometry is independent of and not associated with an entity which itself is not a licensed practitioner. , (I), and(j), [which all refer with specificity to some action which relates to the practice of optometry by a licensed practitioner with an entity which itself is not a licensed licensed practitioner.] This rule has been challenged in the courts and determined to be a valid exercise of delegated legislative authority. Petitioner claims that pronouncements by the Board of Optometry since the passage of the relevant statute and the promulgation of the relevant rule, including a Declaratory Statement by the Board in response to a Petition therefore by Phillip R. Sidran, O.D. in 1991, found at 13 FALR 4804; and in discussion of members at various meetings of the Board’s Probable Cause Panel; all indicate that the Board has formulated a policy regarding the instant issue which is neither a statute nor a properly promulgated rule. In 1991, Dr. Sidran, a licensed optometrist, sought a declaratory statement from the Board regarding the propriety of having a licensed optician share the revenues and responsibilities deriving from the optical portion of his practice. In its Declaratory Statement, issued on October 9, 1991, the Board specifically referred to and quoted the controlling portions of the statute and the rule which it then interpreted as indicating such an arrangement was prohibited. At no time did the Board promulgate new guidelines or expand the strictures imposed by the existing statute and rule. It applied an existing statute and rule to the factual situation posed by Dr. Sidran and concluded that under the facts of that case, the existing statute and rule prohibited the proposed relationship. The subsequent discussion of that opinion at the meeting of the Board’s Probable Cause Panel, convened on January 29, 1992, to consider proposed disciplinary action against Dr. Weber for the situation described here with 20/49, again interpreted existing statute and rule but did not formulate policy. Petitioner further refers to two additional meetings of the Board of Optometry at its meetings on July 8, 1993 and September 12, 1996, at both of which the members present discussed the situation regarding Dr. Weber’s business relationship in 29/49. He claims that in both situations, the Board members made policy statements which should have been formalized through the promulgation of a rule amendment or supplement. Review of the transcripts of those meeting does not support Dr. Weber’s position, however. It is clear that in each case the Board members examined the facts presented to them, applied the existing statutory and rule provisions to those facts, and concluded that the Petitioner’s actions constituted a violation of existing law. The Board’s position vis a vis Dr. Weber’s business arrangement was made a part of the Board’s counter-proposal to the stipulation of settlement initially agreed to by Dr. Weber and the Department’s counsel. In it’s counter-stipulation, which came out of the September 12, 1996 Board meeting, the Board required Dr. Weber to “... change his corporate structure so he is no longer in violation of Section 463.014(1)(b), Florida Statues, and that [his] practice be changed so that he is no longer practicing with a lay person.”
Findings Of Fact Petitioner was an applicant for licensure to practice acupuncture in the State of Florida and took the acupuncture licensing examination in August, 1982. Information was provided to the candidate prior to the administration of the examination which identified refer- ence books to study for the written part of the examination. This included an outline of Chinese acupuncture which explained the technique of opening and closing the hole. There were no texts specified for the practical examination. The acupuncture technique of opening or closing the hole for sedation or tonification was graded as part of the removal portion of the examination. However, Petitioner did not utilize the acupuncture technique of opening or closing the hole as part of his removal technique and was penalized for this omission. The acupuncture examiners were professional examiners from California who are familiar with the different schools of acupuncture thought. Grading procedures were standardized in advance of examination administration and examiners were requested to utilize their professional judgment in assigning grades on each criteria in the performance of three needle insertions. Petitioner contends that he should not have been penalized for failing to close or leave open the acupuncture hole upon needle removal. In the view of Respondent's experts and as stated in the reference material (outline of Chinese acupuncture) this is an essential procedure relative to sedation and tonification. Therefore, Petitioner was correctly graded as to needle removal. Petitioner contends that he would have passed the examination had the practical portion scores been averaged. Under the grading procedures followed by Respondent, Part III (diagnostic written portion) and Section A, Part IV (technique) of the practical examination are graded separately, and the candidate must obtain a satisfactory score on each section. Respondent's separate grading procedures are consistent with Section 468.323, Florida Statutes (Supp. 1982). This provision requires the candidate to cass an examination which tests his knowledge and competency in specified areas including needle removal. This could not be accomplished if an unacceptable score in needle removal were permitted merely because Petitioner did well on other portions of the practical examination.
Recommendation Based on the foregoing, it is RECOMMENDED that Respondent enter a Final Order denying the petition. DONE and ENTERED this 29th day of September, 1983, in Tallahassee, Florida. R. T. CARPENTER 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 29th day of September, 1983. COPIES FURNISHED: Mr. William S. Huang 697 E. Altamonte Drive Altamonte Springs, Florida 32701 Drucilla E. Bell, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ann Mayne, Executive Director Board of Acupunture Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Flori4a 32301
The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Petitioner's Injury At all times, the Petitioner has been employed as a Ladies Wear Department Manager for K-Mart Corporation. On July 21, 1998, Petitioner, while in the course and scope of her employment, was injured when she fell on a metal ladder as she attempted to hang clothes on a rail. Her left knee struck a metal bar on the second step of the ladder, causing immediate pain. On August 26, 1998, Petitioner consulted Dr. Jeffery Friedman, M.D., an orthopedic surgeon, who specializes in knee and shoulder surgery. Dr. Friedman was recognized as an expert in the field of orthopedic surgery. On or about September 4, 1998, Petitioner underwent arthroscopic surgery performed by Dr. Friedman to remove a loose body from the knee. Dr. Friedman found grade III chondromalacia and debrided the area using an arthroscopic shaver. He also found loose articular cartilage at the patella. Dr. Friedman's records describe the area of grade III chondromalacia as "fairly large" and involving " the apex of the patella." However, neither the size nor the shape of the injury is disclosed. Dr. Friedman also debrided flake of articular cartilage from the tibial plateau and removed a calcific loose body from the posteromedial compartment. His post-operative diagnosis was left knee loose body, chrondromalacia, and intracruciate ligament strain. Petitioner returned to work with K-Mart after the arthroscopic surgery, and was placed on light duty. While performing her duties, Petitioner is required to stand most of the time, and is unable to sit. Prior to her injury, Petitioner worked 40 hours per week. After her injury, due to her physical limitations resulting from the accident, Petitioner is only able to work 24 hours per week. Petitioner's pain limits her ability to work 40 hours per week. Petitioner cannot put her full weight down on the left knee while going up steps or a ladder or it causes sharp shooting pains. In addition, continuous walking results in continuous aching pain. The reduction in Petitioner's work hours was due to her injury. Petitioner is now unable to perform all of the duties that were required of her before the injury. Dr. Friedman found Petitioner to have reached maximum medical improvement in December 1998. In early 1999, Petitioner sought treatment for continued pain. An MRI was performed on or about March 5, 1999, which suggested a small defect in the articular cartilage, thinning of the patellar cartilage, and narrowing of the medical femoral tibial joint consistent with the early stages of osteoarthritis. In June, 1999, Petitioner underwent steroid injections for continued pain. In September, 1999, Petitioner returned to Dr, Friedman because of continued pain. Dr. Friedman reviewed a video tape that he had made of the arthroscopic surgery and fount that the Petitioner had a fairly large chondral defect of the patella. Dr. Friedman determined that Petitioner was a candidate for ACI, also known as the Genzyme Carticel Procedure (Genzyme Procedure). Dr. Friedman believed that the ACI procedure would benefit Petitioner by providing long-term symptomatic relief with joint pain and mechanical disturbances and improved joint motion function, eliminating the complaints of grinding and catching, and furthering the goal of returning the patient to regular and even strenuous activity. Petitioner then requested authorization for the ACI procedure. The Employer/Carrier denied the request and referred it to the Agency for Health Care Administration for review in accordance with Florida law. The Agency consulted with the University of Florida Faculty Practice Group, and Dr. B. Hudson Berrey, Chair of the Department of Orthopaedics and Rehabilitation, rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. Dr. Berrey further opined that there was not reliable evidence that ACI would provide significant benefit to the recovery and well-being of the injured employee within the meaning of Rule 59B-11.004(3), Florida Administrative Code. The documents and information forwarded to Dr. Berrey by Respondent included Petitioner's medical records provided by Intervenor, K-Mart carrier. Dr. Berrey did not review any actual MRI films, did not review any films taken at the time of the arthroscopic procedure, and in fact only reviewed certain documentation that was supplied to him by the agency. Petitioner was denied her right to present information to Dr. Berrey prior to his forming his opinion for the agency. This was a violation of Rule 59B-11.003, Florida Administrative Code. The agency rendered a decision based upon Dr. Berrey's opinion, declining to order the Employer/Carrier to provide ACI to Petitioner. Autologous Chondrocyte Implantation The ACI procedure was initially developed in Sweden by Dr. Lars Peterson. ACI is a surgical procedure whereby a sample of cartilage is harvested from another area of the joint. The harvesting of the cartilage is performed during an arthroscopic surgical operation. The sample is sent to Boston to the laboratory of Genzyme Tissue Repair, Inc. ("Genzyme"), the owner of the process. Genzyme uses its proprietary process to culture the cells into an estimated 12 million chondrocytes over a period of approximately two months. Genzyme then returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted on the wounded cartilage and covered with the periosteal flap. The ACI procedure thus requires two surgical operations, one arthroscopic procedure and one open procedure. The claimed benefit of ACI is that the cartilage that is generated and implanted onto the knee will be hyaline cartilage or hyaline-like cartilage rather than fibrocartilage. Hyaline cartilage is composed both of the cartilage cells of an extra-cellular matrix. It has greater ability than fibrocartilage to withstand compression and shearing forces. ACI has been shown to produce "hyaline-like" cartilage in some patients. However, it does not reproduce the extra- cellular matrix in which the chondrocytes are found in naturally occurring hyaline cartilage. Alternative Treatments Other available treatments for a defect in articular cartilage of the knees include abrasion chondroplasty, arthroscopic microfracture, and arthroscopic drilling. Many patients get relief with one or more of these alternative procedures and do not need another operation. In addition, a surgical procedure to elevate the tibial tubercle and remove some of the weight from the patella might also alleviate the Petitioner's pain and improve her functioning. Dr. Friedman performed an abrasion chondroplasty during the arthroscopic surgery of September 4, 1998. Dr. Friedman did not offer Petitioner either the microfracture or the drilling procedures. Dr. Friedman had considered performing a tibial tubercle elevation but has not recommended that the Petitioner undergo that procedure either before the ACI is approved or independently of the ACI. Dr. Friedman views the primary purpose of this procedure as assuring the best possible results from the ACI. Dr. Friedman indicated there were no appropriate alternative medical procedures, other then the ACI procedure, available for Petitioner's injury. Dr. Friedman opined that the only viable option of putting back normal articular cartilage underneath the kneecap would be with the ACI procedure. In this opinion, the alternative procedures are not appropriate for and would not benefit Petitioner, as they were merely temporary procedures. Moreover, he emphatically stated that the ACI procedure is the procedure which is appropriate for an would benefit Petitioner. The Evidence That ACI Remains Investigative The Agency for Health Care Administration has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Sections 440.13(15) or 408.02, Florida Statutes; therefore, there was no Agency-approved protocol for Dr. Berrey to consider in rendering his opinion. Dr. Berrey testified that he could find no articles or publications describing controlled studies in which the effectiveness of ACI compared to any other procedure. Dr. Berrey further testified that he could find no articles about the ACI procedure in peer-reviewed journals in which the authors used objective measures of outcome which compared the patients' condition before and after treatment. The use of blinded or controlled studies is important so that possible confounding factors or variables can be controlled or accounted for and the results measured objectively. Dr. Berrey found that the publications cited by the proponents of the procedure discussed research which was funded by Genzyme, the owner of the process by which the chondrocytes were cultured. The funding of the research by the owner of the process was an additional factor in his determination that the evidence supporting the efficacy of the procedure was not reliable. The Cartilage Repair Registry and the results reported therein do not constitute reliable evidence of the benefits of ACI when compared to other available procedures for two reasons. First, the potentially confounding variables are neither controlled nor accounted for. Second, each surgeon evaluates his or her own work, so that there is no objective, independent measurement or assessment of the condition of each patient before and after surgery. Although the premise on which ACI is based is that the patient's implant will consist of hyaline cartilage rather than fibrocartilage, the available data does not indicate that the results are comprised only, or even primarily, of genuine hyaline cartilage. Rather, the evidence is that some patients develop "hyaline-like" cartilage, or cartilage composed partly of hyaline tissue. It cannot be determined whether hyaline or hyaline- like cartilage has filled a patient's defect without performing a biopsy and a histological evaluation of the tissue. The published reports described in the testimony contain discussions of post-surgical histological performed on very small numbers of patients. The published reports concerning the use of ACI to treat defects of the patella show that the results are not as favorable as those claimed for treatment of the femoral condyle. After the proponents of the procedure began to perform other procedures with the ACI to assure that any defects in the alignment of the patella are repaired, improved results were reported. Dr, Friedman testified about the published results of histological evaluations of 37 patients. Of those, seven underwent ACI to treat defects of the patella. Only one of the seven showed the development of hyaline-like tissue. Further, only two of the seven patella patients reported surgical results classified as good or better. Dr. Friedman opined that the histological data resulting from treatment of defects of the patella had improved since the study described in the preceding paragraph. However, he could not give any reference to the basis for his opinion. Dr. Friedman further testified that the more recent articles discussed the results of patients who had been followed from nine to 15 years. However, the articles and presentations from 1997 to 2000 report on follow-up of the first hundred patients between two and nine years after their surgery. Dr. Billings testified that Dr. Peterson's presentation discussed follow-ups of ACI patients occurring as long as 15 years after surgery. Yet, the March 2000 presentation to the American Academy of Orthopedic Surgeons focused on 40 patients who had been evaluated three or more years after their surgery. The FDA granted an accelerated approval of the Carticel product in 1997. The original accelerated FDA approval was granted for defects of the femoral condyle, the trochlear groove, and the patella. The terms of the approval require that controlled studies be conducted which compare the procedure to other procedures available for the treatment of focal chondral defects, specifically, microfracture and the creation of a periosteal flap without the injection of the cultured chondrocytes. None of the expert witnesses had found in their literature search any published reports of the progress of the controlled studies required under the terms of the accelerated FDA approval. In February, 2000, the FDA approval was modified. Genzyme is no longer permitted to market the ACI procedure or its Carticel product for treatment of defects to the patella. The requirements of Rule 59B-11.004, Florida Administrative Code, differ significantly from those of the accelerated FDA approval process, so that the granting of accelerated approval does not determine the answer to the question whether a treatment is investigative under that rule. The FDA's inquiry addresses the issues of safety and efficacy. However, the accelerated FDA approval process does not address the issues of whether a particular product is more effective than currently existing treatments or is equally cost-effective. Based upon all the evidence, the performance of the ACI procedure on the defects located in the patella is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. The Probability That ACI Would be of Significant Benefit in Returning Petitioner to Work Both of Petitioner's expert witnesses testified that if she does not undergo ACI, it is likely that she will need a total knee replacement. However, neither witness testified that Petitioner currently requires a total knee replacement. No testimony was presented as to when Petitioner might require a total knee replacement. Despite the testimony that ACI has been studied for 20 years, the published reports follow patients only for nine years after surgery. From the current state of the research, it is not possible to conclude that patients who undergo ACI avoid the need for subsequent surgery in ten or more years. The published studies of the results of ACI going out nine years from the date of surgery do not state the number of procedures performed on the patella. No witnesses testified regarding any published studies of the effectiveness of ACI that addressed the extent to which patients had been able to return to work as a result of the procedure. There is insufficient evidence from which to conclude that the ACI is more likely to enable the Petitioner to return to her duties that other available procedures. The Likelihood That the Benefits of ACI Would Outweigh the Risks and the Costs The testimony compared the cost and benefit of ACI with chondroplasty, microfracture or drilling, and, to some extent, a Macquet procedure or tibial tubercle elevation. Each of the other procedures requires only one surgical operation. ACI requires an arthroscopic surgical procedure to harvest cartilage, culturing of the chondrocytes at the Genzyme laboratory in Boston, and followed by an open surgical procedure to create a periosteal flap and to implant the chondrocytes. Petitioner's expert testified that the cost of culturing the chondrocytes alone was between $8,000 and $10,000, in addition to the two surgical procedures. Petitioner's expert compared the cost of ACI to that of a total knee replacement. However, that comparison is not appropriate under the rule because there is no evidence that Petitioner currently needs a knee replacement or that a knee replacement is the treatment generally used to treat her current condition. The cost of the abrasion chondroplasty, the microfracture or drilling procedure would approximate the cost of the first stage of ACI, approximately $2,300. Dr. Billings testified that the cost of the second stage of ACI was greater than that of the first stage. The second stage is an open surgical operation rather than an arthroscopic one. The total cost of the ACI procedure, including therapy, is probably close to the $30,000 required for a total knee replacement, including the therapy required for the total knee replacement. Dr. Berrey testified that published reports of the cost of ACI are as high as $37,000. The ACI requires extensive physical therapy; Petitioner presented no evidence as to the extent to which the cost of this aspect of treatment was included in the total cost of ACI. ACI has been established to be safe, so that the benefits of the procedure outweigh the risks. However, there is insufficient evidence from which to conclude that the benefits of ACI outweigh the additional costs.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying approval of the autologous chondrocyte implantation for Petitioner Rebecca Crane. DONE AND ENTERED this 27th day of November, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE 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 27th day of November, 2000. COPIES FURNISHED: Jeffrey J. Bordulis, Esquire 570 Crown Oak Centre Drive Longwood, Florida 32750 Lisa J. Hurley, Esquire Pyle, Jones, Hurley & Hand, P.A. 1069 West Morse Boulevard Winter Park, Florida 32789 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308
Findings Of Fact Petitioner passed all parts of the acupuncture examination except section one of Part Four, which was the clinical practical segment of the examination. That portion required the demonstration of various needling techniques and was independently graded by two observer-examiners. Respondent then averaged the two grades to arrive at a single score for each technique Petitioner was required to demonstrate. Respondent administered its first acupuncture examination in December, 1981, and its second in August, 1982 (at issue here). The examinations were developed and administered in consultation with California examiners, since that state had the greatest experience in testing and licensing acupuncturists. Petitioner raised no factual dispute with respect to examiner credentials, qualifications tested, or the scoring system. Rather, Petitioner pointed to alleged errors by the examiners in administering and grading certain questions. Additionally, Petitioner contends the reading list given for the written portion of the examination was misleading in that it was not intended to apply to the practical portion. Petitioner points to several questions where he received full credit from one examiner and a much lower grade from the other. Rather than averaging the two grades, Petitioner believes the lower grades should be thrown out as errors. However, Respondent instructed its examiners to give full credit where they failed to observe a specific technique or were otherwise uncertain of the performance. Thus, there was no showing that these diverse grades were other than a result of an examiner's failure to observe (for which Petitioner was not penalized). Petitioner further challenges the instructions given, contending the examiner erred in administering certain questions. Again, however, it is at least as likely that Petitioner misinterpreted instructions which were properly given. Petitioner contends he was misled by the reading list provided in advance of the examination. It was not clear, as Respondent argues, that the reading list was intended only for the written portions of the examination. However, Petitioner did not show that this misunderstanding prevented him from performing satisfactorily on the practical portion of the examination. Petitioner challenges the examiner's "eyeballing" techniques to grade his selection of proper acupuncture points. Respondent concedes this is not a precise method in all cases. However, the tolerance permitted on point location will allow for slight examiner error as well as reasonable candidate error. This was shown to be an acceptable scoring method by the testimony of Respondent's expert witness.
Recommendation Based on the foregoing, it is RECOMMENDED that Respondent enter a Final Order denying the petition. DONE and ENTERED this 14th of July, 1983, in Tallahassee, Florida. COPIES FURNISHED: Clarine Smissman, Esquire 217 North Eola Orlando, Florida 32801 Drucilla E. Bell, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ann Mayne, Executive Director Board of Acupuncture Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 R. T. CARPENTER 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 14th day of July, 1983.
Findings Of Fact Petitioner applied for and took the 1982 acupuncture examination consisting of four parts. He failed Part IV the clinical practical, or hands- on, part of the examination dealing with needle insertions, manipulation and needle removal, patient care, sanitation and antiseptic application. In 1983 the Florida Legislature created the Board of Acupuncture within the Department of Professional Regulation and empowered the Board with the authority to adopt rules. Perhaps in conjunction with that transfer of authority, the 1983 acupuncture examination was cancelled, and no examination was given during 1983. Effective August 13, 1984, the Board enacted rules regulating the examination and re-examination of acupuncturists. In October, 1984, a restructured three-part acupuncture examination was administered. The practical Part of that examination, Part III, was divided into two sections: the written practical section and the clinical practical section. Petitioner took the clinical practical section of Part III but was not required to take the written practical section of Part III. Petitioner again failed the clinical practical section. In December, 1984, Petitioner was notified in writing as to his 1984 examination results and was advised in an accompanying document that the deadline for filing an application to retake the acupuncture examination in 1985 would be May 24, 1985. That same accompanying document also advised Petitioner that candidates who failed either section 1 or section 2 of Part III must retake both section 1 and section 2 of Part III. Petitioner made the decision that he would not take the 1985 acupuncture examination but rather would wait until the 1986 acupuncture examination was given. However, when Petitioner "got laid off" from his employment, he decided to take the 1985 examination, mailing his application therefor the day before the deadline. In July, 1985, Petitioner retook Part III of the acupuncture examination. Petitioner received a score of 54 on the written practical section and a score of 65 on the clinical practical section. A score of 70 or greater on both sections is required in order to achieve a passing grade for Part III. Petitioner requested a review of his grades. That review revealed that although errors were found in scoring the written practical section, Petitioner's adjusted grade on that portion of the practical Part of the examination remained below the required 70. The review of the clinical practical section of that Part of the acupuncture examination revealed that both examiners who graded Petitioner on the clinical practical section evaluated Petitioner identically as to those areas in which Petitioner's performance was inadequate, agreeing item by item.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is, RECOMMENDED that a Final Order be entered finding that Petitioner failed both sections 1 and 2 of Part III of the 1985 acupuncture examination; denying Petitioner's request that his grade be set aside and that he be permitted to retake the examination without first completing the educational requirements; and denying Petitioner's application for certification to practice acupuncture in the State of Florida. DONE and RECOMMENDED this 24th day of October, 1986, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of October, 1986. COPIES FURNISHED: Marcelle Flanagan, Executive Secretary Board of Acupuncture 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wings S. Benton, General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Bruce Alexander, Esquire 9200 South Dadeland Boulevard Suite 515 Miami, Florida 33156 H. Reynolds Sampson, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Regulation of those practicing acupuncture first became law in Florida with the passage of Chapter 80-375, Laws of Florida (1980). Therein it was declared unlawful for any person to practice acupuncture in this state unless such person has been certified by the Department of Professional Regulation. This statute, as amended, and now contained in Section 468.323, Florida Statutes (1981), requires an applicant for certification to practice acupuncture in this state to pass an examination which tests the applicant's competence and knowledge of the practice of acupuncture and "includes a practical examination of the skills required to practice acupuncture, covering diagnostic techniques and procedures, point/meridian selection, needle insertion, manipulation and removal, patient care, sanitation and antiseptic application." The technique of point/meridian selection, needle insertion, manipulation and removal, which Section 468.323 requires a successful applicant to demonstrate are techniques basic to traditional Chinese acupuncture. All of these Petitioners failed the clinical practical portion of the examination given in August, 1982. The August, 1982, examination was the second examination given in this state to applicants for certification to practice acupuncture. The first examination was given in December, 1981. Due to the lack of known-to-be qualified examiners in Florida, Respondent contacted the State of California, who has licensed acupuncture practitioners since 1976, and arranged to have acupuncturists who have served as examiners in California, serve as examiners for the practical part of the Florida examination for the examinations given in December, 1981, and August, 1982. All of the examiners who administered and graded the practical portion of the August, 1982, examination have practiced acupuncture for at least five years and have served as examiners in California for at least three years. Most of these examiners hold degrees in medicine or oriental medicine and all are highly qualified acupuncturists. All of these examiners were assembled before the commencement of the examination and instructed for twelve to eighteen hours to assure that all were grading on the same scale and their grades would be as consistent as practicable. They were provided with Acupuncture Examiner Manual (Exhibit 14) which contains grading criteria for each task on the practical examination. Petitioners contend that this examiner manual established grading criteria for procedures that are unnecessary and/or not practiced by many acupuncturists, thereby taking from the examiners the initiative to grade the examinees on their overall demonstration of acupuncture techniques. A careful review of Exhibit 14 does not compel this conclusion. To the contrary, Exhibit provides the examiners with examples of techniques that demonstrate competence as well as techniques demonstrating superior performance. As noted below, the areas in which the greatest number failed was in location of acupuncture point and length of needle/angle of insertion/manipulation. In the former a passing grade was given if the candidate needled on the proper meridian. A superior grade resulted if the candidate was less than one-half inch off point and on the meridian. In the latter the candidate received a passing score if he got two of the three, viz, angle of insertion, length of needle and/or manipulation, correct. Either twisting and twirling or lifting and thrusting of the needle was accepted for manipulation for either tonification or sedation. Instructions were mailed to all applicants advising of the time and place of their examination; the format of the examination; the bibliography of books to study for Part II of the examination, Theory and Practice of Acupuncture; how Part IV of the practical examination will be graded and that it will consist of: (1) Needle Insertion, Manipulation and Removal and (2) Patient Care, Sanitation and Antiseptic Application (Exhibit 4). Also forwarded to the applicants were the rules governing acupuncture clinics, Chapter 10D-81, Florida Administrative Code, and Chapter 21-12, Florida Administrative Code, covering licensing procedures for acupuncturists, including scope of the examination. Every examinee's scores for items 6, 11, and 16 on Part IV.1 of the August, 1982, examination intended to test examinees' performance in needle inspection prior to insertion were invalidated by Respondent at the examination because: Candidates did not adhere to this criteria, it would appear that while this is a vital precautionary measure to be utilized in the practice of acupuncture, candidates, however, consistently failed this criteria. The contention is that since applicants used newly purchased pre-packaged needles, disposable needles, and their personal needles, the assumption is that candidates were confident of the "good" condition of needles, and with the exception of one candidate this appears to be true. Prior to the August, 1982, acupuncture licensure examination, Respondent did not specify to Petitioners any text as reference for the clinical practical portion (Part IV) of the examination, nor did Respondent expressly notify Petitioners that they would be tested on points/meridian location in Part IV.1 of the examination. Respondent did not instruct examiners for the August, 1982, examination that they had to determine the accuracy of Petitioners' point/meridian location through the examinees' use of the proportional measurement method, including the comparison of the size of their hand to Petitioners' hands, and then palpation, and the examiners did not use this method of determining the accuracy with which Petitioners located acupuncture points on the clinical practical examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they were required to insert the needle at an angle, either with or against the flow of energy along the meridian, in order to receive a score for "correct angle" on the August, 1982, acupuncture licensure clinical practical examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they had to demonstrate one of the needle manipulation techniques known as "twisting and twirling" or "lifting and thrusting" in order to receive a score for "correct manipulation" on the August, 1982, acupuncture licensure clinical examination. Respondent did not notify Petitioners by rule or otherwise that "needle manipulation" would be graded in two separate items on the grade sheet for each acupuncture point on the examination. Nor did Respondent notify Petitioners expressly in writing prior to the examination that they had to close the hole for tonification and leave the hole open for sedation in order to receive a score for "proper removal" of the needle on this examination. Respondent did not notify Petitioners expressly in writing prior to the examination that they had to cleanse hands by washing with soap or scrubbing with alcohol or an antiseptic solution prior to handling needles and that they had to maintain "sterile hands" when handling any of the needles in order to receive a "pass" score for item 2 of Part IV.2 of the examination. Nor did Respondent so notify Petitioners that they had to use an antiseptic agent, such as betadine solution, hydrogen peroxide, or alcohol, to cleanse the skin area in which needle insertion was to be performed in order to receive a pass score for item 3 of Part IV.2 of this examination. Nor did Respondent so notify Petitioners that once their hands had been cleansed the cleansed hands could not be used to adjust their clothing or in any other manner that would not maintain sterility in order to receive a "pass" score for item 4 of Part IV.2 of the examination. Respondent did not adopt a rule specifying the criteria by which examiners were to be selected prior to the August, 1982, acupuncture examination, nor did Respondent adopt a rule specifying point/meridian location as a grading criterion for the August, 1982, examination. "Superior manipulation" and "extreme care exercised" are not terms of art in the practice of acupuncture. Acupuncture is defined in the statutes and rules to mean "the insertion of needles into the human body, or the treatment of specific skin areas by means of mechanical, thermal, or the electrical stimulation, for the purpose of controlling and regulating the flow and balance of energy in the body." There are numerous "schools" of acupuncture throughout the world where "masters" teach different techniques. However, all of these schools teach the traditional Chinese theory of acupuncture which is to balance the energy in the body by "tonifying" those areas where there is insufficient energy and "sedating" those areas with too much energy. No evidence was presented that different acupuncture "points" are used at the differing schools of acupuncture or that proper results can be obtained if the needle is not inserted accurately on the point to he needled. These "points" are where needles are inserted and manipulated to increase or decrease the flow of energy on that meridian. The differences in these schools of acupuncture, including the western or scientific, consists mainly of techniques used to attain the desired end. Of these techniques, depth of needle, angle of insertion, and how a needle is manipulated to stimulate the point are perhaps the most significant. Of the three texts referred to the applicants for study, two describe the traditional Chinese art of acupuncture, while the third, by Felix Mann, tests the Chinese art of acupuncture against western scientific bases to demonstrate the efficacy or lack thereof of some of these procedures. While a scientific basis for certain of the traditional Chinese theories cannot be demonstrated, Mann, and others in the scientific world, contend these theories to be without merit. Pursuant to the Chinese school of acupuncture, both depth and angle of insertion of the needle are important. For tonification this school teaches that the needle be angled with the flow of energy, and stimulation of the point is attained by: (1) Repeatedly lift the needle gently subtaneously, then thrust it back with force; (2) Twist and twirl the needle back and forth with small amplitudes and slowly; (3) Insert the needle slowly, twirl it gently. When withdrawing, rest the needle just beneath the skin for a short interval, then withdraw it swiftly; and (4) After withdrawing the needle, close the acupuncture hole by applying slight pressure over it, preventing the vital energy from the channel from escaping. For sedation the needle is inserted against the flow and the manipulations above-noted for tonification are, insofar as practicable, reversed and the hole is left open for the excess energy to escape (Exhibit 6). Traditional Chinese acupuncture emphasizes the importance of point location, angle of insertion, depth of penetration of the needle, the type manipulation used and opening or closing of the hole. All schools emphasize the importance of point location. Some schools, finding little scientific basis for angle and depth of insertion, de-emphasize the importance of these techniques. Many contend that there is no basis for angled insertions solely for tonification or sedation, that with adequate stimulation, depth of needle is unimportant and that almost any type of stimulation is adequate for either tonification or sedation. Little scientific basis for leaving the hole open or closing the hole for sedation and tonification, respectively, has been demonstrated. Since many acupuncture practitioners in the western world, particularly medical doctors, attain stimulation by the use of electricity, and electricity will pass through body tissue easier than manually transmitted vibrations of the needle, the depth of penetration for these practitioners using electrical stimulation is not particularly important. Accordingly, those practitioners give little weight to depth of penetration. Manipulation of the needle during and after insertion consists principally of lifting and thrusting or twisting and twirling. The needle can be moved only in three dimensions, but the speed and amplitude of those movements can be varied. Variations of the speed, amplitude and direction of the movement of the needle are obtained by "plucking" the needle, "scraping" the needle, "shaking" the needle, "flying" the needle, and "trembling" the needle. (Exhibit 28) Movements in certain directions with emphasis are specified for tonification and other movements for sedation are important in the practice of traditional Chinese acupuncture. In the instructions given to the applicants, including all of these Petitioners, they were directed to bring acupuncture needles of various sizes they would use in their practice and all material needed for sanitation and antiseptic application. For Part IV of the examination, each applicant was advised prior to the examination (Exhibit 5) that he/she would be required to perform needle insertion, manipulation and removal on themselves for three different acupuncture points, that the examiner will designate the points on which needle insertion, manipulation and removal are to be performed; that they were to demonstrate for the examiners how they would treat a patient in their clinic when performing needle insertion, manipulation and removal; that they are required to demonstrate only the proper sterilization and sanitation procedures and proper needling techniques for the designated acupuncture points; and that minutes is allotted for this portion of the test. The examination was conducted in a motel room having a sink for the applicant to wash his hands, a straight chair and coffee table for applicant to sit on and set up his equipment and two chairs for the two examiners. Upon entry into the room, each applicant was given the information contained in Exhibit 10. Several Petitioners testified Exhibit 10 was not read to them, while all examiners testified that Exhibit 10 was read to each applicant. All Petitioners who testified prepared a lower leg for acupuncture, all acknowledged that they used a different needle for each insertion, and each acknowledged that he/she was directed to tonify or sedate three specific points. Exhibit 10 directs the procedures each Petitioner testified he followed with the possible exception of the words "using correct angle and needle manipulation" following the directions to "tonify spleen 6" or "sedate liver 4." While a few of the Petitioners attributed their failure to use correct needle angle prescribed by traditional Chinese acupuncture to the failure of the examiners to so instruct them, most of the Petitioners who didn't angle the needle testified that they used a perpendicular needle angle of insertion of the needle because they didn't believe in the efficacy of angling the needle; or to the instruction to insert the needle as they would on a patient in their clinic. Since they didn't use angled insertions on their patients or "close the hole" or "leave the hole open" when treating their patients, they didn't demonstrate the use of those techniques on the examination. Petitioners' primary complaints about the examination concern the failure of Respondent to more specifically tell them exactly what they would be required to do on the practical part of the examination to obtain a passing grade. Su Liang Ku was a successful applicant for licensure on the August, 1982, examination and testified as an expert witness in these proceedings. He acknowledged that the instructions that he was given were not all-encompassing and that he did not always "close the hole" when applying tonification procedures to patients in his office; however, he clearly recognized the need to demonstrate to the examiners all of the appropriate techniques when taking an examination. Ku had taken exams in Burma, China and California before taking the Florida examination and was not surprised by the tests he was asked to perform on the practical examination or uncertain whether the needle should be angled, the hole closed or left open, or whether he should demonstrate more than one technique used to stimulate the point. Had some of these Petitioners recognized and kept in mind this innate distinction between adequate clinical procedures and examination procedures, they, too, would have passed this examination. Petitioner William Skelton failed Part IV of the examination largely because he was graded zero by both examiners for "needle manipulation and removal" for two of the three points. He was also given a below average by both examiners on needle length for one point. Skelton understood he would be examined on traditional Chinese acupuncture, and to tonify a point, he angled the needle in the direction of flow. He also understood point location was very important and that when told to tonify Spleen 6 he was expected to insert the needle at the correct point. Despite his acknowledgment that he understood he was being examined in traditional Chinese acupuncture, Skelton closed the hole on one point traditional Chinese acupuncture indicates should be left open. Petitioner Anna Alvarez failed Part IV of the August, 1982, examination largely as a result of the marks she received from both examiners on length of needle/angle of insertion/manipulation. These marks were 2 for both examiners for points 2 and 3 while for point 1 examiner A scored her performance zero and examiner B scored it 2. Had a passing mark from each examiner been awarded for all three points on this item of the examination, she would easily have passed Part IV of the examination. Ms. Alvarez testified that she did not understand she was being graded on point selection; however, she received passing marks in accuracy of location of acupuncture points from both examiners for all three points. Ms. Alvarez also testified that she achieved chi at two points and after receiving chi it is not necessary to manipulate the needle. While this procedure may well be appropriate in practice, the examiner can hardly determine that the applicant is competent as an acupuncturist unless acupuncture techniques are demonstrated. Simply announcing the arrival of "chi" after which additional stimulation may not be necessary, does not demonstrate manipulation. On the third point, Liver 4, she testified that she did not want sedation so she did not try to get chi. She also testified that the needle was inserted perpendicular to the skin for each point. One of the criteria tested on this part of the practical examination is angle of insertion. While the efficacy of angle of insertion is disputed by many, it is entrenched in traditional Chinese acupuncture and all candidates were aware that the examination would be in this field. Applicants were not given a failing score if needle was not angled, but received a higher score if this technique was demonstrated. Petitioner Paul Gonzalez failed Part IV of the August, 1982, examination largely because of the grades he received in accuracy of location of acupuncture point and in length of needle/angle of insertion/manipulation. For point one, Gonzalez was marked zero by both examiners. He testified that he was told to do Liver 8 and he got mixed up and inserted the needle at Kidney 8. He also testified that he had brought only 1-1/2 inch needles to the examination despite instructions received in Exhibit 4. On cross examination he testified that he had other needles with him but used only 1-1/2 inch needles in the examination. Gonzalez expected to he tested on traditional Chinese acupuncture procedures and attempted to demonstrate those techniques and needle insertion and manipulation. However, of the six grades received for each of the four sections on which the candidates were graded (two examiners x three points) Gonzalez received 2 - 3's and 4 - 2's for length of needle/angle of insertion/manipulation. Only on point 3 did his total score for a point reach the passing level of 3. Gonzalez angled the needle against the flow when he was told to sedate Gall Bladder 41. He also testified he was not told to tonify or sedate the other two points; however, this is contrary to the testimony of the examiners that they read Exhibit 5 to all applicants and to the testimony of other witnesses that they were told to tonify or sedate each point to be needled. Petitioner Edward Rumsey failed Part IV of the August, 1982, examination after receiving zeros from both examiners on point selection for point 1, a 3 and a 0 for point selection for point 2, and 2 - 2's for point selection for point 3. For needle manipulation and removal he received zeros from both examiners for points 1 and 2. In each of the 4 techniques tested for the three points, Rumsey received a total score less than 12 which reduces to an average score of less than 3 needed for passing. Rumsey testified he studied the books on Chinese acupuncture listed on Exhibit 4. When told to tonify Stomach 36, he inserted needle perpendicular to the skin. When told to tonify Spleen 10, he inserted the needle at an angle to the flow. When told to sedate Gall Bladder 41, he again inserted needle perpendicular to the skin. Rumsey further testified the only manipulation technique he used was twisting the needle and he didn't demonstrate closing the hole or leaving the hole open. As with other applicants, the examiners who tested Rumsey were seated in chairs facing Rumsey and could observe him clearly. Rumsey, as did several other witnesses, contended the examiners could not ascertain the needle was inserted more than 1/2 inch from the correct point unless they actually measured. The various acupuncture points are located a certain number of "cuns" from an anatomical landmark and there are a specified number of cuns between two anatomical landmarks. For example, Exhibit 9, p 91, shows there are 8 cuns between the nipples on a man's chest. An experienced acupuncturist should be able to locate a point with considerable accuracy by viewing the anatomical landmark and, by eye, selecting the point 3/8, 1/4, etc. of the distance between these landmarks. Petitioner, David Bole, failed part IV of the August, 1982, examination because he received an average score high enough to pass only one of the four criteria graded by the examiners, viz, "condition of needle - handle comes in contact with skin." On needle manipulation and removal, he received for point 1 a 0 and a 3; for point 2 - 3 zeros; and for point 3 - 2 fours. On accuracy of point location, Bole received 2 - 3's for point 1; a zero and a 3 for point 2; and a 4 and a 3 for point 3. For length of needle/angle of insertion/manipulation, he received scores of 3 and 2 for point 1; 2 and 3 for point 2; and 3 and 4 for point 3. Bole also received a mark of at least one fail by both examiners in the sanitation part of Part IV. Any grade of fail in the sanitation portion of the examination results in a final grade of fail. Bole testified he holds a Ph.D. in psychology and has been practicing acupuncture under the supervision of a medical doctor. He studied the recommended texts to prepare for the examination, but relied on his experience, past training and instruction to proceed as he would with a patient in his own clinic, in demonstrating his proficiency in traditional Chinese acupuncture. Bole testified he inserted the needle at an angle with the flow when directed to tonify and against the flow when directed to sedate. He also demonstrated closing the hole or leaving the hole open as appropriate. He used the same swab to clean all points as well as to seal the hole and he used 1-1/2 inch needles for all points. Bole acknowledged that knowing length of needle used allows the examiner to determine the depth the needle is inserted. His principal objection is that insufficient directions were given to applicants for the applicants to understand exactly what they were expected to demonstrate. Harvey J. Kaltsas failed Part IV of the August, 1982, examination by reason of the low scores he received in accuracy of locating acupuncture point and length of needle/angle of insertion/manipulation. On point location Kaltsas received passing grades of 3 by each examiner for points 1 and 2, but for point 3, received grades of 0 and 2. For length of needle/angle of insertion/manipulation he received a 2 from each examiner for point 1, a 3 from each examiner for point 3, and one 2 and one 3 for point 2. Kaltsas testified that in his training, the angle of insertion of the needle is the most important factor in needling. To prepare for the examination Kaltsas studied the texts recommended in Exhibit 10 and assumed the examiners would be looking for methods of tonification and sedation discussed in the books on traditional Chinese acupuncture. For each of the three points he was told to tonify or sedate, he inserted the needle perpendicular to the skin. Kaltsas also testified he didn't think the examiners were looking for point location because they didn't take physical measurements to check the accuracy of each point he needled. Petitioner Marie Burleson failed Part IV of the August, 1982, examination partly as a result of running out of time before point 3 was needled. However, even if the score on point 3 could be ignored, Burleson would have failed all of the criteria except "needle manipulation and removal." For the accuracy of location of the two points needled, Ms. Burleson received two 2's for point 1 and one 2 and one 3 for point 1. Zeros were given for point 3. For length of needle/angle of insertion/ manipulation, Burleson received a score of 3 from one examiner for points 1 and 2, but a score of 1 from the other examiner. For a "condition of needle" Petitioner received a score of 4 from one examiner for points 1 and 2, but received a score of 0 and 3 from the other examiner. Both the examiners scored Burleson zero on point 3. Burleson attributed her difficulty in not completing point 3 to the fact that she had no comfortable place to put her foot while she was needling the leg. She testified that when she started to insert the needle in point 3, her foot slipped off the chair and the needle was bent. Burleson is a graduate of an acupuncture school in California from which she took most of her studies by correspondence. She spent only one month full-time in classrooms before graduation. At the examination, Burleson used a one-inch needle inserted perpendicular to the skin for both points 1 and 2. She demonstrated closing the hole for the two points tonified. Petitioner Henry Meritt failed Part IV of the August, 1982, examination as the result of failing all of the criteria except "condition of needle" for which he was graded a 3 by each examiner for each of the 3 points. He also failed the sanitary part of Part IV with respect to his handling of needles. For accuracy of location of acupuncture point Meritt scored 3's for points 1 and 2 and zero for point 3 by both examiners. For length of needle/angle of insertion/manipulation, Meritt scored a zero and 2 for point 1, two 2's for point 2, and a zero and a 3 for point 3. For "needle manipulation and removal" both examiners scored Meritt zero for points 1 and 2 and he received a 2 and a 4 for point 3. Meritt contends he was not instructed to demonstrate how he located the points to be needled and that he thought, as did others, that point location was to be graded only in Parts II and III of the examination. In view of Finding of Fact 5 above, that point location is the most important element in acupuncture, such contentions are simply not credible. Without inserting the needle on the point or at least on the meridian on which this point is located, the desired results are not obtainable. This Petitioner testified tonification is obtained simply by leaving the needle inserted and without manipulation, that he used 1-1/2 inch needles for all points, that it was immaterial what length needle he used because they were inserted only 1/4 inch and that his two examiners were unprofessional during the time he was in the room taking his practical examination. He graduated from Doctor Dale's Institute in New York and refers to himself as Dr. Meritt although he has no doctoral degree in medicine or anything else. Petitioner Charles McWilliams failed Part IV of the August, 1982, examination by reason of obtaining a total score from both examiners below that required for passing in all of the criteria tested except "condition of needle - handle comes in contact with skin" on which he received a score of 3 from each examiner for each of the 3 points. For accuracy of location of acupuncture points, examiner A gave him a 4 for each of the 3 points, while examiner B awarded him scores of 3, 2 and 0 for points 1, 2 and 3, respectively. For length of needle/angle of insertion/manipulation for point 1 he received scores of 1 and 2; for point 2 scores of 2 and 3; and for point 3 scores of 2 and 2. For "needle manipulation and removal" for point 1 he received scores 2 and 0; for point 2 scores of 2 and 0; and for point 3 scores of 0 and 3. McWilliams testified he understood the practical part of the examination would be based on the texts to which he had been referred in Exhibit 4; that he angled his needle; that a 1-1/2 inch needle was used to tonify Stomach 36 (point 1) and Spleen 10 (point 2) and a 1-inch needle was used to sedate Gall Bladder 41 (point 3); that when he withdrew the needle from point 3, a drop of blood appeared and he put a swab on the hole; and if the latter motion constituted closing the hole, he closed the hole at point 3. McWilliams does not adhere to the theory that closing the hole or leaving the hole open is effective in tonification or sedation. Petitioner James Bissland failed Part IV of the August, 1982, examination because of failing scores received in accuracy of location of acupuncture point and length of needle/angle of insertion/manipulation and because he received a fail score from examiner A on the use of antiseptic solution on the skin prior to needle insertion on all three points needled. Bissland's scores for accuracy of point location were 2's for points 1 and 2 and 3's for point 3. For length of needle/angle of insertion/manipulation he scored a 1 and a 2 for point 1; a 1 and a 2 for point 2; and 2's for point 3. Bissland contends he did not know he would be graded on accuracy of point location but, had he known, he would have done nothing different than he did on the examination. Bissland studied the texts referred to in Exhibit 4 and expected Part IV of the examination to be a demonstration of the knowledge presented in Parts II and III. When told (by Exhibit 5) that he should demonstrate to the examiners the procedures he used in his own clinic, Bissland testified that is what he did. For each point Bissland used a 1-inch needle and a Japanese shallow needle technique with each needle penetrating 1/4 to 1/2 inch. No angling of the needles was performed. Bissland normally provides stimulation by electricity and does not angle the needles unless anatomically necessary. Since he was advised that electrical stimulation would not be allowed on the examination, he demonstrated slow and rapid insertion of the needle, slow and rapid rotation of the needle, and what he considered proper removal of the needle. Petitioners' expert witness, Peter Lu, took and passed the acupuncture examination in August, 1982. His father and grandfather were both Chinese medical doctors and Lu graduated from Hong Kong Western Pacific College where he studied acupuncture and Chinese medicine for four years. He considers point location and depth of needle insertion very important in acupuncture and an examiner can judge the depth of insertion by the length of the needle used. He was taught for tonification to angle the needle with the flow and to close the hole to prevent the escape of energy. For sedation he was taught to angle the needle against the flow and to leave the hole open to release the undesirable energy. Lu would consider a demonstration unsatisfactory if an examinee bent a needle while needling himself. Petitioners presented an expert witness who opined that test results on a practical examination were unreliable when two examiners on a scale of 0 to 4 gave scores 3 or more points apart. Here, the examiners were directed to give the applicant being tested a passing score if they could not clearly see what the applicant was demonstrating. This expert also testified the grades are unreliable where one examiner awards a pass and the other a fail. On the sanitation and antiseptic application part of the examination, the only grades authorized are pass and fail. At one point on the scale on which such performance is weighed there must be a equipoise between pass and fail. Thereafter, whichever way the scale is tilted determines the grade assigned. In this examination, the two examiners agreed on the grade to be assigned for 81 percent of the applicants. Part of the 19 percent on which they disagreed can be attributed to the instructions to award a pass score if the demonstration couldn't be clearly seen by the examiner. Even without this instruction, a difference of only 19 percent is a reasonable deviation in scores assigned by two examiners.
Findings Of Fact Dr. Norman S. Bateh is the Petitioner in this matter and is an unsuccessful candidate on the optometry (theory and practice) licensing examination administered by the Respondent Board of Optometry on July 23 through 25, 1983. The development of, an examination by this Board reflects careful planning and consideration to ensure it fairly tests an applicant's knowledge of the subject matter. Prior to the preparation of a particular examination, a large pool of questions is developed from numerous professional and academic sources. After the examination is given, an analysis of it is conducted to see how the questions are received by the examinees. Examinees are given the opportunity to contest particular questions after the examination has been administered. Based on the Board's analysis of the test results, any question that was answered correctly by less than 58 percent of the examinees, in addition to those questions contested by the examinees are sent for verification to the Board's consultants, in this case Drs. Pappas and Chrycy. If, upon review by the consultants, it appears a question was incorrectly graded, ambiguous, unclear, or unfair; or if, in the consultant's opinion, there is any sort of problem with the question, all examinees are given credit for it. Passing grade on the 100-question, multiple-choice examination was 70 percent. Petitioner was initially awarded a grade of 66, but on review, at his request, of several of the questions which were graded as wrong, he was awarded two more points, which brings his grade to 68, still two points below passing. He was ranked 98th out of 103 examinees. Petitioner challenges four questions at this hearing as being either improperly graded or invalid because the question is incapable of a correct answer. These questions are numbered 8, 31, 73 and 78 and will be discussed individually, infra. If Petitioner's answer is determined to be correct, he will be awarded one point credit for that question. If any question is determined to be invalid for any reason, Petitioner will be awarded one point credit for that question. Question 8 on the examination read: Intraocular lens placement after cateract extraction results in an image magnification of approximately: 0% 4% 9% D. 25% Petitioner's answer on the examination was "C. 9%." The Board's correct answer was "B. 4%." Petitioner presented the testimony of an ophthalmologist, Dr. Schnauss, who has performed the operation to implant intraocular lenses between 500 and 600 times. As an expert who has used the lenses in his practice frequently and as consultant to one .of the major manufacturers of these lenses, e states unequivocally the degree of magnification is less than 1 percent, but not 0 percent. The further away from the location of the original lens of the eye, the greater the magnification. Since the lens implant is close to the plane of the original eye lens, there would be little magnification. Therefore, notwithstanding the conclusions of the Respondent's experts, Dr. Pappas and Dr. Chrycy, both consultants to the Board of Optometry, who cite Duane, Clinical Ophthalmology, Vol. I, as authority, no answer listed as an option on the examination is clinically correct. However, 52 percent of the candidates who took this particular examination gave the Board's correct answer. Question 31 on the examination read: Which of the following would you consider a positive scotoma: the blind spot Evan's angia-scotomas Seidel's scotoma muscae volitantes Petitioner's answer on the examination was "C. Seidel's scotoma." The Board's correct answer was "D. muscae volitantes." A scotoma is a blind spot in the patient's vision. Positive scotomas are those which are noticeable by the patient as he sees. Negative scotomas are not noticeable to the patient, but show up under test. A Seidel's scotoma, which is an extension of a blind spot, would not be a positive scotoma because the patient would not see it in the visual field. The Board's preferred answer, muscae volitantes, was attacked by Petitioner's experts as being inaccurate since they are bits of floating protein substance in the eye which, .though they are opaque and create a block to vision where they exist, are not true blind spots because they are not a defective area in the eye and they move. They are blind only because they temporarily block vision, not because they are a defect in the eye. Therefore, while muscae volitantes are, technically, positive scotomas where they exist, the question is inartfully drawn, vague and confusing, a conclusion supported by the fact that only 28 percent of the candidates got the correct answer. This low figure, to Mr. Gustafson, Respondent's test statistician, is insignificant. However, a question so confusing that only 29 of 103 examinees get it right and which is capable of such substantial meritorious argument on both sides is truly vague. Question 73 on the examination read: A keratoconus patient with "K" readings of 46.00 x 52.00 can best be fitted with which lens: a spherical firm lens a soft lens with overglasses a bitoric gas permeable lens with light touch on the cone a bitoric gas permeable lens with heavy touch on the cone Though Petitioner testified his answer was "D," and he defended it at the hearing, his answer on the examination was "A." The Board's correct answer was "C." The prime consideration in this question is the touch of the lens, not the issue of hard or soft, or gas permeability. The most current edition of Mandell's textbook and the majority of optometrists today feel that the best choice of lens for fitting a keratoconus patient is the bitoric gas permeable lens with light touch. The opinion of the "majority of optometrists" referred to by Dr. Chrycy was garnered in discussions with a personal friend who, as a Fellow of the American College of Optometry, had recently attended a meeting of that body where this exact subject was, discussed and that opinion rendered. Petitioner cited an earlier edition of Mandell's work to urge the position that a firm lens is required to contain the protrusion of the dark part of the eye that comes along with keratoconus. Later opinion, however, changes that position which is now no longer considered the better treatment. Petitioner also challenged the "K" readings in the question as being unreliable. Unfortunately by doing so, reasonable asthat might be in the practice of optometry, he read into the question a factor that was neither present nor intended by the examiners. The "1(" readings in this question were agiven quantity. Petitioner's treating them as a "trick" was an unfortunate mistake. It is also pertinent to note that 71 of the 103 examinees (69 percent) chose the correct answer to this question. Question 78 on the examination, the fourth and last one challenged by Petitioner at the hearing, reads: The extraocular muscle most frequently involved in extropia is the medial rectus superior rectus lateral rectus superior oblique Petitioner's answer was "C. lateral rectus." The Board's correct answer was "A. medial rectus." The term "extropia" means a turning outward of the eye. The term "extraocular" means outside the eye. The medial rectus muscle is the muscle between the eye and the nose which pulls toward the center of the face. The lateral rectus muscle is that on the outward part of the eye which pulls toward the ear. In a normal individual, the muscles, of equal strength, balance each other and the eye looks forward unless the person involved moves it. Extropia is caused when there is an imbalance of the muscles, either by a weakening of the medial rectus, which allows the normallateral rectus to overpower it, or by an unnatural strengthening of the lateral rectus which then overpowers the normal medial rectus. By far the greater weight of optometric opinion, based on observation and testing, reveals that the most frequent" cause of this condition is the weakening ofthe medial rectus, leaving the lateral rectus normal. Consequently, the correct answer is not lateral rectus as claimed by Petitioner, but the medial rectus as stated by the Board,notwithstanding even the Board's expert, witness testified there is no definitive authority to support the Board's choice. In this case, 64 percent of the examinees chose the correct answer.
Recommendation Based on the foregoing, it is RECOMMENDED: That a final order be entered finding that Petitioner should be awarded one additional point credit for Question 31 and that he, nonetheless, failed to achieve a passing score on the July, 1982, optometry examination. RECOMMENDED this 19th day of August, 1983, in Tallahassee, Florida. ARNOLD H. POLLOCK Division of Administrative Hearings Department of Administration 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 19th day of August, 1983. COPIES FURNISHED: Abraham I. Bateh, Esq. 2124 Park Street Jacksonville, Florida 32204 Drucilla E. Bell, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Mr. Fred Rochep Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Mildred Gardner Executive Director Board of Optometry Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Petitioner sat for the August 24, 1991 Optometry licensure examination. He did exceedingly well on two of the three portions of the examination. His grade on the clinical portion (sections 1 and 2) was 71.5. The minimum passing score was 75.0. Petitioner challenged the behavior of the examiners in section 2 of the clinical portion of the examination, and the grade he received for several individual procedures tested. Petitioner's patient for the clinical examination was his wife, Susan Vazoulas. Mrs. Vazoulas testified that prior to Petitioner entering the examination room for section 2 of the clinical portion of the examination, she overheard the two examiners, one male and one female, discussing material already on their clipboards. The male examiner indicated he had given an "81". The female examiner indicated she had given an "84", but was a "hard liner." Petitioner was not present during this exchange. Mrs. Vazoulas did not see what was on the examiners' clipboards and could not testify with any certainty as to what was being discussed. Every reasonable inference suggests that the examiners' conversation did not apply to Petitioner's section 2 clinical test for the following reasons: The examiners' comments were made before the Petitioner entered the examination room and before he began to take his section 2 clinical examination. The numbers "81" and "84" bear no relationship to any of Petitioner's scores on any portion of his licensure examination. The examiners for section 2 were not the examiners for section 1, whereon Petitioner scored 100%. If anything, had the examiners reached two divergent scores of 81 and 84, respectively, it would more likely suggest the presence of independent judging and the lack of collusion, instead of the presence of collusion and absence of independence as assumed by Petitioner in this instance. The examination room in which section 2 of Petitioner's clinical examination was administered was very small, approximately 8 x 10 feet. During section 2, the two examiners separately viewed each of 16 procedures performed on Mrs. Vazoulas by Petitioner and after each procedure, they individually returned to their respective clipboards to record their scores. The two clipboards were placed on a countertop side by side while not in use. Petitioner and Mrs. Vazoulas each observed the examiners separately marking their respective clipboards but never saw what was written down by either of the examiners. Petitioner and Mrs. Vazoulas felt it would have been hard for each examiner to avoid seeing the score assigned by the other examiner, but neither Petitioner nor Mrs. Vazoulas observed any actual sharing of information or scores during Petitioner's section 2 clinical examination or afterwards. Petitioner and Mrs. Vazoulas testified in terms of the examiners having "the chance" to see each other's clipboard and "the opportunity" for collusion and absence of independence in grading. In this instance, Petitioner considered that identical grades given by both examiners was proof of their collusion and arbitrary and capricious grading. However, similarity of scores is equally susceptible of being interpreted as resulting from each examiner having observed the same performance by Petitioner on each of the 16 procedures and applied the same judging criteria to what s/he saw. The law does not presume illicit behavior without more evidence than that it "could have" happened. Petitioner challenged his section 2 grade for clinical procedures 4-9 for biomicroscopy, alleging that he was graded 17.5 out of a possible 20 points while all parts were checked "yes". In fact, the score sheets show that all parts were not checked "yes" by both examiners. One examiner graded procedure four with "N" for "no". This could result in an "all or nothing" score of zero for that item. Assuming, arguendo, the "yes" and "no" were averaged, Petitioner's score still would not have amounted to the additional 2.5 points Petitioner alleged he was entitled to out of this section of the examination. Respondent's Exhibit 2 is a document titled "Optometry Practical Examination Section 2 - Grading Standards August 1991." The instructions to the examiners state in the second paragraph of that document, "Comment on reason for any NO judgment. Comment if performance was a marginal YES." Thus, examiners could legitimately insert comments even where they responded "yes" in evaluating the performance of the candidate in a given procedure. They did so here. Petitioner challenged his grade on procedure number 15, gonioscopy, stating that partial credit should have been given for the showing of the proper angle. Petitioner's Exhibits 1 and 2, the grade sheets for section 2, reflect that Petitioner received no credit from either examiner. Both "no" responses have comments recorded next to them. Respondent's Exhibit 2, page 4, states the criteria for a "yes" response on procedure number 15, gonioscopy, as: Must be focused on nasal angle with proper illumination Gives proper response to question Both criteria must be satisfied to receive a "yes" response. Petitioner and Respondent concur that Petitioner correctly demonstrated the angle required in procedure 15, gonioscopy, which satisfied one of the two required criteria to receive a "yes" from either examiner. Petitioner attempted, by extrapolation of procedure 5, to show that the remaining criterion was also met. He was not persuasive in this attempt. The grade sheets reflect that Petitioner failed to satisfy the second criterion: to give the correct response to the question posed. Petitioner made no valid showing that he did answer the question correctly or that the points available from this answer would raise his total score 3.5 points for a passing grade. Petitioner challenged his grade for procedure number 1, binocular indirect ophthalmoscopy (BIO). Petitioner admitted that he did this procedure incorrectly by using the 3:00 o'clock position, rather than the 9:00 o'clock position requested by the examiners but felt six points should not have been deducted and it should have been marked "yes, marginal," awarding him a majority of the six lost points. Petitioner did not demonstrate good cause within the grading criteria in evidence why he should have received the "majority," presumably four, points. Petitioner presented no evidence concerning the grading of challenged procedures 11 and 14. As to all of the foregoing, Petitioner's challenge to the effect that he did not understand the grading system was not sufficient to carry his burden of proof to establish that the examination, scoring, and/or grading system was arbitrary or capricious.
Recommendation Upon the foregoing findings of fact and conclusions of law, it is recommended that the Department of Professional Regulation enter a final order ratifying the examination grade previously assigned to Petitioner. DONE and RECOMMENDED this 15th day of September, 1992, at Tallahassee, Florida. ELLA JANE P. DAVIS, Hearing Officer Division of Administrative Hearings The De Soto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of September, 1992. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 92-2205 The following constitute specific rulings, pursuant to S120.59 (2) F.S., upon the parties' respective proposed findings of fact (PFOF) Petitioner's PFOF: None filed Respondent's PFOF: 1-6 Accepted except for unnecessary, subordinate on cumulative material. 7-13 Accepted except for subordinate material. It is noted that Petitioner bears the burden of proof herein, not Respondent. COPIES FURNISHED: Vytas J. Urba Assistant General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 George L. Vazoulas 182C Chestnut Ridge Drive Harrisonburg, VA. 22801 Diane Orcutt, Executive Director Department of Professional Regulation, Board of Optometry 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Suite 60 Tallahassee, Florida 32399-0792
The Issue Whether the Respondent committed the violation alleged in the Administrative Complaint issued October 2, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for investigating and prosecuting complaints against persons holding licenses in the health professions and occupations, including chiropractic physicians. See § 456.073, Fla. Stat. The Board of Chiropractic Medicine ("Board") is the entity responsible for imposing penalties against chiropractic physicians for violations of Section 460.413(1), Florida Statutes. See § 460.413(2), Fla. Stat. At the times material to this proceeding, Dr. Falowski was a chiropractic physician licensed to practice chiropractic medicine in Florida, having been issued license number CH 5108. Dr. Falowski was first certified in Florida to practice chiropractic medicine in 1986. Dr. Falowski also is certified to administer propriety drugs. At the times material to this proceeding, Dr. Falowski did business as Rainbow Rehabilitation, and his address of record was 4201 North State Road 7, Lauderdale Lakes, Florida 33319. On or about August 25, 2997, Dr. Falowski submitted an application for acupuncture certification to the Department. He paid a fee and was certified to take the acupuncture certification examination. His application reflects that he completed 105 hours of acupuncture training at the University of Miami. Dr. Falowski took the acupuncture certification examination in November 1997, but he did not pass the examination. On or about April 15, 1998, Dr. Falowski submitted a second application for acupuncture certification to the Department. He paid a fee and was again certified to take the acupuncture certification examination. His application reflects that he completed acupuncture training at the University of Miami. Dr. Falowski took the acupuncture certification examination in May 1998 and attained a passing score. On or about July 7, 1998, the Department mailed an Examination Grade Report to Dr. Falowski, advising him that he had passed the chiropractic certification examination for acupuncture. A Request for Registration Form for the Board of Chiropractic Medicine was included with the Examination Grade Report, and the instructions stated that the form and a check or money order must be returned to the Department within 45 days. The form listed a $100.00 fee for the Chiropractic Acupuncture Certification. There is nothing in the records of the Department indicating that it received the Request for Registration Form or check in the amount of $100.00 from Dr. Falowski, nor do the records reflect that Dr. Falowski has been issued an acupuncture certification.4 On or about December 28, 2005, writing was observed on the window of the Rainbow Rehabilitation office which stated: WE DO PHYSICALS & BLOOD WORK LICENSED ACUPUNCTURE EKG No acupuncture license number was listed on the window. Dr. Falowski intended to perform acupuncture treatments for any member of the public who requested these treatments at Rainbow Rehabilitation.5
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Chiropractic Medicine enter a final order Finding that Francis J. Falowski, D.C., offered to practice acupuncture when he was not certified to do so, in violation of Section 460.413(1)(t); Imposing an administrative fine against Dr. Falowski in the amount of $5,000.00; and Placing Dr. Falowski on probation for a period of two years, under such terms and conditions as the Board deems appropriate. DONE AND ENTERED this 20th day of March, 2008, in Tallahassee, Leon County, Florida. PATRICIA M. HART 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 20th day of March, 2008.
