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
The Issue The issues in this case are whether Respondent violated Subsections 456.072(1)(gg), 456.072(1)(y), and 460.413(1)(q), Florida Statutes (2005),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with the regulation of chiropractic medicine pursuant to Chapters 20, 256 and 460, Florida Statutes. Dr. Guerriero is a licensed chiropractic physician with the State of Florida, having been issued license number CH 6373 on or about August 21, 1991. The Professional Resource Network (PRN) is the impaired practitioners program for the Board of Chiropractic Medicine pursuant to Section 456.076, Florida Statutes. PRN is an independent program that monitors the evaluation, care, and treatment of impaired healthcare professionals. PRN oversees random drug screens and provides for the exchange of information between treatment providers and the Department for the protection of the public. On or about October 26, 2005, Dr. Guerriero was admitted to the Center for Drug Free Living, Inc., for detoxification related to opiate and benzodiazepine use. On October 31, 2005, he self-reported to PRN that he was discontinuing the use of benzodiazepines and opiates prescribed by his doctor and that he had entered the Center for Drug Free Living, Inc., to be weaned from these prescription medications. PRN arranged for Dr. Guerriero to be evaluated by Chowallur Dev Chacko, M.D. (Dr. Chacko), who is a psychiatrist. The evaluation was made to determine whether Dr. Guerriero's addiction problems prevented him from practicing chiropractic medicine with reasonable skill and safety to patients. Dr. Chacko saw Dr. Guerriero on November 7, 2005. Dr. Guerriero admitted to continuing the use of prescription medications containing opioids and benzodiazepines after his recent detoxification. Dr. Chacko diagnosed Dr. Guerriero as having opioid and benzodiazepine dependence, as well as suffering from alcohol abuse. It was Dr. Chacko's opinion that Dr. Guerriero was not able to practice chiropractic medicine with reasonable skill and safety. He recommended that Dr. Guerriero receive inpatient substance abuse treatment. After PRN received the evaluation performed by Dr. Chacko, there were several unsuccessful attempts to contact Dr. Guerriero. However, Dr. Guerriero did talk with his case manager on December 16, 2005, to discuss options for treatment. Dr. Guerriero maintained that he could not afford the inpatient treatment. His case manager informed him that one option would be an intensive outpatient program with no less than nine hours a week of therapy. During the therapy, Dr. Guerriero would not be allowed to practice chiropractic medicine. After the treatment was completed, Dr. Guerriero would be required to be evaluated to determine if he could practice chiropractic medicine with reasonable skill and safety to patients. Dr. Guerriero did not provide PRN with any evidence that he had completed any treatment program. PRN received no further contact from Dr. Guerriero until May 2, 2006. Dr. Guerriero indicated that he wanted to get a second opinion. On July 31, 2006, Martha E. Brown, M.D. (Dr. Brown), who is board-certified in psychiatry and addiction psychiatry, saw Dr. Guerriero for an evaluation. During the evaluation, Dr. Guerriero indicated that he was taking Dalmante, which had been prescribed for him as a sleep-aid. He admitted to drinking from one-to-two glasses of wine three times a week. Dr. Guerriero was given a drug test during the evaluation, and he tested positive for alcohol, opioid, and benzodiazepine use. Dr. Brown's diagnosis of Dr. Guerriero was that he was alcohol dependent, opiate dependent, and sedative hypnotic dependent. It is Dr. Brown's opinion that Dr. Guerriero cannot practice chiropractic medicine with reasonable skill and safety. She recommended that he enter a detoxification program and then a residential long-term treatment program, that he see a pain management specialist to look at his pain issues, that he see a psychiatrist acceptable to PRN to help him with his sleep difficulties, that he abstain from all mood altering substances including alcohol, and that he be in PRN for long-term monitoring. Dr. Guerriero did not provide PRN with proof that he had completed an inpatient program. He did not execute a contract with PRN. PRN sent Dr. Guerriero contracts to sign, but the contracts were returned as unclaimed. The last contact that Dr. Guerriero had with PRN was on August 31, 2006. Jerome M. Gropper, D.D.S. (Dr. Gropper), is a clinical network coordinator at PRN. He is a practicing dentist and has a master's degree in counseling. Based on his review of the PRN file of Dr. Guerriero, he is of the opinion that Dr. Guerriero could not practice chiropractic medicine with reasonable skill and safety and that Dr. Guerriero will need long-term residential treatment before he could safely return to practice. Based on the opinions of Drs. Chacko, Brown, and Gropper, Dr. Guerriero cannot practice chiropractic medicine with reasonable skill and safety to his patients due to his dependence on drugs and alcohol. In order to be able to return to practice chiropractic medicine, Dr. Guerriero will need long- term residential treatment and will need to enter into a monitoring contract with PRN.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Guerriero violated Subsections 456.072(1)(y), 456.072(1)(gg), and 460.413(1)(q), Florida Statutes; imposing a $1,000 administrative fine; and suspending his license until such time the following conditions are satisfied: Dr. Guerriero executes a PRN advocacy contract, Dr. Guerriero successfully completes a six-month period in which he complies with all of PRN's treatment recommendations, PRN appears before the Board and advocates for Dr. Guerriero's return to active practice during a Board meeting in which Dr. Guerriero is present, and (4) the Board determines that Dr. Guerriero is able to practice with reasonable skill and safety. DONE AND ENTERED this 7th day of May, 2007, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 7th day of May, 2007.
The Issue Whether Petitioner should receive a passing grade for the Florida Optometry Licensure Examination taken on July 23 through 25, 2004.
Findings Of Fact Dr. Cook is a licensed optometrist in the State of Michigan. She received her Doctor of Optometry degree in 1985, and became licensed in the same year. Dr. Cook has taken the Michigan, Illinois, and Wisconsin state licensure examinations and passed all three examinations on her first try. For 17 years, Dr. Cook practiced optometry at the University of Michigan Health Services. This was a comprehensive practice, including eye examinations with dilation, treatment of eye diseases, emergency care, and the monitoring and follow-up care of patients with glaucoma, cataracts, and other diseases. Except for providing care to family members, Dr. Cook has not practiced professionally, on a regular basis, since August 2001, when she moved to Florida. Dr. Cook is a Fellow of the American Academy of Optometry. She was accepted at the final hearing as an expert in optometry. Dr. Cook desires to become licensed in Florida to practice optometry. As part of the process to apply for licensure in Florida, Dr. Cook is required to retake parts one and two of the national board examinations and to pass the Florida examination for licensure. She retook the national board examinations and passed on the first try. In August 2003, she took the clinical portion of the Florida examination and failed. In July 2004, Dr. Cook retook the clinical portion of the Florida examination. A passing score on the clinical portion is 80. She scored 75.75 on the July 2004 examination, and, thus, failed the clinical portion. For the clinical examination, Dr. Cook was required to bring her own "patient" upon whom some of the examination's required procedures were required to be performed. Some of the procedures are performed on "patients" brought by other candidates taking the examination. The grading on each procedure in the clinical examination is done by two examiners who are licensed, practicing optometrists. A candidate will be graded by a different set of examiners for the morning and afternoon sessions. The examiners are chosen by the Board of Optometry and trained by the Department's Testing Services Unit and outside practitioner consultants prior to the administration of each examination. The examiners are provided with a set of Grading Standards for their use during the grading of the examination. The purpose of the training and standards is to make the grading process objective and to provide grading uniformity and consistency. The examiners are required to grade and mark their scores independently. They are not to compare or discuss their scoring with other examiners at any time. If both examiners' grades agree, the candidate is given either no credit or full credit, depending on whether the examiners considered the procedures were properly performed. If the examiners disagree on the grading, the candidate is given the average of the two grades actually awarded, which is the sum of the two grades divided by two. If an examiner considers that a procedure is properly performed, the examiner marks the grade sheet with a "Y," indicating a yes. Examiners are taught to give the candidates the benefit of the doubt in borderline cases. If an examiner feels that the performance was borderline, the examiner must indicate "borderline" in the comment section on the grade sheet and specify the reason. If an examiner determines that the candidate did not properly perform the procedure, the examiner marks the grade sheet with an "N," indicating a no. An examiner is required to specify the reason for a no grade in the comment section on the grading sheet. Some of the procedures are performed once for both examiners. Other procedures are performed in groups, meaning that the procedures are performed twice, once before each of the examiners. In grouped procedures, the first examiner will read the directions for a procedure, and the candidate will perform the procedure after the directions are given. The first examiner will read the directions for the next procedure, and the candidate will perform the procedure after the directions are read. This format continues until the grouped segment is completed. The same procedures will then be performed for the second examiner, following the same format used by the first examiner. No records are kept to indicate which examiner graded first or second during any part of the examination. The examination candidate has control over when each examiner grades the candidate. When the candidate is ready to be graded, the candidate is required to say, "Grade me now." Dr. Cook has challenged the grades that she received for the following procedures: confrontational field test; measurement of pupil size; rating patient's response to light; demonstrating the equator and posterior pole during the binocular indirect ophthalmoscopy examination; the anterior vitreous portion of the biomicroscopy examination of the anterior segment; the choroidal crescent, posterior vitreous detachment, A-V three crossings out find and reflex, and hypertensive changes portion of the biomicroscopy examination of the fundus; and measuring eye pressure using a Goldmann Tonometer. A confrontational field test is a gross neurological field test in which the candidate compares her visual field to the patient's to pick up gross neurological defects. The Candidate Information Booklet (CIB) states that the confrontational field test is to be performed as described in Clinical Opthalmology by J.D. Duane. In order to perform this test, the candidate sits in front of the patient about a meter away. The patient covers one eye and looks at the candidate's eye, nose, or other structure so that the patient's gaze is not moving around. The candidate puts her non-moving fingers in different quadrants to test the patient's ability to see the fingers. It is important to keep the fingers stationary while performing the test because moving fingers could be detected by the patient even in a blind field. In other words, a patient who is not able to see a stationary finger may be able to detect a finger that is moving because the motion contributes to the detection. Dr. Cook performed the confrontational field test for both examiners simultaneously. She received .75 points out of a possible 1.5 points for the confrontation field test. Examiner 202 gave Dr. Cook full credit for the examination. Examiner 239 gave Dr. Cook no credit and noted the following in the comment section: "Moving fingers--Init performed 'wiggling fingers' while moving target fingers." Examiner 239 also noted "Did very brief static CF test but fingers moving not stationary." Dr. Cook admitted that she did wiggle her fingers during part of the performance of the examination, claiming that she was testing the patient's peripheral vision, which was not part of the examination. The examination was to be performed within the central 30 degrees. The preponderance of the evidence does not establish that Dr. Cook tested the four quadrants with non-moving fingers. Dr. Cook's score of .75 points is correct. As part of the clinical examination, the candidates are required to measure the size of the patient's pupil. In order to measure the pupil, the candidate must not sit in front of the patient. Sitting in front of the patient creates a stimulus for accommodation, which is a phenomenon where the pupil size changes unless the patient can look and focus on a target at a distance. Dr. Cook measured the pupil size of her patient simultaneously for both examiners. Examiner 202 gave Dr. Cook full credit for her performance in measuring the pupil size, and Examiner 239 did not give Dr. Cook credit for her performance. Examiner 239 noted in the comment section, "candidate sat in front of pt." Dr. Cook received .5 points out of a possible one point for measuring the pupil size during the pupillary examination. Dr. Cook claims that she sat off to the side of the patient, lined up her right eye with the patient's right eye, and asked the patient to sight at a target at a distance. The examiners were off to the side when Dr. Cook performed the procedure. The preponderance of the evidence does not establish that Dr. Cook was in the correct position when she measured the patient's pupil size. Dr. Cook's score of .5 is correct. As part of the examination, candidates are required to rate the patient's pupillary response to light on a pupillary scale. The CIB states, "Pupillary examinations, muscle balance, and motility, should be done on both eyes (including dilated eye)." Examiner 202 gave Dr. Cook full credit for rating the pupil, but indicated that her performance was borderline. Examiner 202 stated in the comment section: "borderline - she was confused about 0 to 4+, but eventually got it." Examiner 239 gave Dr. Cook no credit for her performance, and stated in the comment section: "4+ but did not indicate eye, not used to using 0 to 4 scale." Dr. Cook received .5 points out of a possible one point for rating the pupil on a pupillary scale. She gave the same answer simultaneously to both examiners. When Dr. Cook was asked to rate the pupils of her patient, Dr. Cook was uncertain which scale to use, the Marcus Gunn scale or a true light reflex scale. She indicated that she gave a response for both scales and that one of the responses was 4+. Dr. Cook stated at the final hearing that the left pupil was fixed and dilated, but she did not indicate that she rated the left eye as "0." The preponderance of the evidence does not establish that Dr. Cook advised the examiners of her rating of the left pupil. The score of .5 was correct. The binocular indirect ophthalmoscope (BIO) is an instrument used to examine the fundus, which is the inside back part of the eye. The BIO sits on the candidate's head. There is a small mirror attached, through which another viewer may see the view being seen by the candidate. The candidate holds a condensing lens, which is like a magnifying glass, to evaluate structures in the eye. Examining the fundus with the BIO is a simple procedure, which Dr. Cook performed 14 to 16 times every clinical day for over 17 years. Dr. Cook wore contact lenses during the examination. With the use of contact lenses, Dr. Cook has perfect vision. Dr. Cook adjusted the instrument before the testing procedure started, including adjusting the angle of light and setting the illumination. As part of the examination on the use of the BIO, a candidate is to demonstrate the equator and the posterior pole. In these procedures, the candidate finds the view of the applicable area, one examiner looks through the mirror after the candidate says "Grade me now," and then steps back. The second examiner then looks at the mirror after the candidate again says "Grade me now." Examiner 239 did not give full credit to Dr. Cook in demonstrating the equator. For the portion of the performance which requires the candidate to demonstrate an equator landmark, Examiner 239 gave Dr. Cook a "no" and stated in the comment section: "No clear view through the mirror @ 'Grade me now.'" Examiner 239 also gave Dr. Cook a "no" for an acceptable view of an equator landmark and stated in the comment section: "Dim illumination." Examiner 202 gave Dr. Cook credit for these two performance areas. In the portion of the examination in which the candidate is to demonstrate the posterior pole, the candidate is told that the disc and macula should be seen simultaneously. Examiner 239 did not give Dr. Cook credit for the portion of the examination where the disc and macula are to be viewed simultaneously. Examiner 239 stated in the comment section: "very dim view vis'd ONH not macula." Examiner 202 gave Dr. Cook credit for this portion of the examination. Between the first and second examiners' viewings for the equator and the posterior pole, the patient did not move, Dr. Cook held the focused view still, there was no change in illumination or intensity, and Dr. Cook did not change her position. Thus, it is more likely than not that Examiner 239 was mistaken. Dr. Cook received 3.5 points out of a possible seven points for examining the views of the equator and posterior pole during the binocular indirect ophthalmoscopy examination. She should be credited with an additional 3.5 points. As part of the examination, the candidates were asked to perform an examination using a biomicroscope, which is a microscope combined with a light source that is used to view different structures on the outside and inside of the eye. It is also called a slit lamp. For purposes of the licensure examination, the biomicroscope has a teaching tube attached through the left ocular, and when the examiner looks through the tube she sees the same view the candidate sees through the left ocular. A portion of the examination using the biomicroscope includes grouped procedures. The last procedure on one of the grouped procedures was focusing on the anterior vitreous of the patient's eye. The vitreous is made up of hyaluronic acid and contains vitreal strands made of collagen. As a person ages, the vitreal strands will increase and become more visible. A young patient may have vitreal strands that would be so difficult to see that on viewing the strands the view would appear to be "optically empty." In other words, the vitreous would appear clear on examination. Dr. Cook's patient was a healthy premed student in his early twenties. The patient did not have visible vitreal strands. Before performing the group of procedures, which included the focus of the anterior vitreous, Dr. Cook adjusted the height and width of the light. She set for a direct focal illumination, meaning the light was focused where she was looking. The patient remained still between the procedures, and Dr. Cook did not change the illumination between each grading. Examiner 216 gave Dr. Cook no credit for her focus of the anterior vitreous, stating the illumination was "too dim" and the "vit not seen." Examiner 268 gave Dr. Cook full credit for that part of the examination. Dr. Cook received 1.25 points out of a possible 2.5 points for her performance related to the anterior vitreous portion of the biomicroscopy exam of the anterior segment. Based on the patient's having no visible vitreal strands; the patient not moving between the grading procedures, and Dr. Cook not changing the illumination between grading procedures, it is more likely than not that Examiner 216 was mistaken. Dr. Cook should be awarded 1.25 points for performance of the focus on anterior vitreous. Dr. Cook received 3.5 points out of a possible seven points for her performance related to the choroidal crescent, posterior vitreous detachment, A-V three crossing outs, find and reflex, and hypertensive changes portion of the biomicroscopy exam of the fundus. One of the grouped portions of the examination using the biomicroscope included demonstrating whether a choroidal crescent was present. Determining the presence of a choroidal crescent was the fourth procedure in this grouped segment. A choroidal crescent can be seen when the candidate is looking at the optic nerve and the retina does not come all the way up to the nerve. The choroidal crescent will appear at the edge of the optic nerve. Examiner 268 did not give Dr. Cook any credit for determining whether the choroidal crescent was present, and stated in the comment section, "Did not focus on the edges of the ONH [optic nerve head]." Examiner 216 gave Dr. Cook full credit for the procedure. Dr. Cook did not demonstrate by the greater weight of the evidence that she should be given additional credit for this procedure. Unlike the evidence presented concerning the anterior vitreous, she did not establish that there was no change in illumination, her position, or the patient's position between the grading of the grouped segments. In order to perform the grouped procedures in which she was tested on the presence of the choroidal crescent, Dr. Cook had to move the focus and illumination to different locations related to the optic nerve. The last procedure in the same grouped segment involving the choroidal crescent was demonstrating posterior vitreous separation. Vitreous gel is attached to the back of the eye in several places. When the attachment points for the vitreous are pulled away or become loose, a ring-like structure can be seen where the vitreous pulled loose. Dr. Cook was asked to demonstrate and indicate whether a vitreous separation was present after she performed the procedure involving the choroidal crescent. The proper procedure for checking for posterior vitreous attachment would be to set the proper illumination, focus on the optic nerve, and pull back slightly on the "joy stick." Examiner 268 did not give Dr. Cook any credit for the procedure involving a demonstration of a posterior vitreous separation, stating in the comment section, "Did not pull back." Examiner 216 gave Dr. Cook full credit for the procedure. Again, Dr. Cook failed to establish by a preponderance of the evidence that she should be given additional credit for this portion of the examination. There was no showing that all conditions remained the same when each examiner graded this grouped segment of procedures. Another grouped segment of the examination called for Dr. Cook to start at the optic disc and follow a temporal arcade for a distance of approximately three disc diameters and demonstrate an AV crossing. Dr. Cook was to then indicate whether there were any characteristic hypertensive changes at the crossing. A vascular arcade is a curved shape with blood vessels coming out and arcing toward one another. Most of the blood vessels in the eye are located in this area. Some diseases such as diabetes and hypertension cause changes where the blood vessels in the arcade cross. In order to perform the AV crossing procedure, a candidate has to coordinate the microscope, going up and down and side by side. Lining up is critical on this procedure. Adjustments have to occur separately, once for each examiner. Examiner 268 did not give credit to Dr. Cook for this portion of the examination, stating in the comment section, "No view in the tube." Examiner 216 gave Dr. Cook full credit for the procedure. Dr. Cook has failed to establish that she is entitled to additional points for this portion of the examination. The AV crossing procedure involves making adjustments for each of the examiners as part of the examination, Dr. Cook has not demonstrated by a preponderance of the evidence that all conditions remained the same for each examiner. As part of the examination, candidates are tested on the use of the Goldmann Tonometer, which is a device used to measure eye pressure. The grading on this portion is divided into four categories: illumination at the proper angle, mires alignment, thickness of alignment, and the pressure measurement. Examiner 268 gave Dr. Cook full credit for all categories. Examiner 216 did not give credit to Dr. Cook for having the correct mires alignment, and gave full credit for the remaining categories, indicating that the mires width and the reading of the pressure were borderline. In the comment section, Examiner 216 drew the alignment which he viewed. The mires were not aligned correctly. Dr. Cook received 1.24-1.50 points out of a possible 2.5-3.0 points for the use of the Goldmann Tonometer. Dr. Cook argues that because she was given credit for the pressure reading that it would be impossible for the mires alignment to be incorrect. The reading of the pressure is to test the candidate's ability to read the dial on the tonometer; it is not to determine whether the reading that is on the dial is the actual pressure of the patient. The grading standards require that the examiner put down the reading that he saw during the viewing if it is different from the reading that the candidate gives as a response. Thus, it is possible to be given credit for the pressure reading without having the mires aligned correctly. Dr. Cook has not demonstrated by a preponderance of the evidence that she should be given additional credit for this portion of the examination. None of the examiners testified at the final hearing. The Department did call Dr. Gary McDonald, who was accepted as an expert in optometry.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered awarding Dr. Cook an additional 4.75 points for the clinical portion of the optometry licensure examination given on July 23 through 25, 2004, resulting in a passing grade of 80.25. DONE AND ENTERED this 30th day of June, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL 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 30th day of June, 2005. COPIES FURNISHED: Edwin A. Bayó, Esquire Gray Robinson 301 South Bronough Street, Suite 600 Post Office Box 11189 Tallahassee, Florida 32302-3189 Allen R. Roman, Esquire Department of Health Office of General Counsel 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 Joe Baker, Jr., Executive Director Board of Optometry Department of Health 4052 Bald Cypress Way, Bin C07 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Has Petitioner's challenge to the failing grade he received on the November 1988, chiropractic licensure examination been rendered moot by virtue of his having retaken and passed the examination? If not, should his challenge be sustained?
Findings Of Fact Based upon the record evidence, the Hearing Officer makes the following Findings of Fact: The licensure examination administered by the Board of Chiropractic Examiners in November 1988, consisted of a written examination on Florida laws and rules and a practical examination. There were three parts to the practical examination: x-ray interpretation; technique; and physical diagnosis. To pass the practical examination, a candidate needed to receive a passing grade on each of the three separate parts of the examination. Mathesie passed the written examination on Florida laws and rules, as well as the x-ray interpretation and technique portions of the practical examination. He received a failing grade, however, on the physical diagnosis portion of the practical examination. The physical diagnosis portion of the practical examination is conducted orally. To facilitate review of this portion of the examination, it is videotaped. The videotape of the physical diagnosis portion of the practical examination in controversy in the instant case was played during the course of the hearing. Each candidate taking the physical diagnosis portion of the practical examination is asked a series of questions by two examiners who also independently grade the candidate's answers. The examiners are experienced chiropractors who have been licensed to practice chiropractic in the State of Florida for at least five years. First-time examiners receive three hours of training in testing and grading procedures and requirements. Examiners who have previously participated in the examination process are given a one or two hour refresher course. In questioning a candidate on the physical diagnosis portion of the practical examination, the examiners must cover at least four and no more than six of the following subject areas: case history; chiropractic examination; general physical examination; orthopedic examination; neurological examination; x-ray technique and diagnosis; laboratory diagnosis; nutrition; differential diagnosis; and clinical judgment. In addition, they are directed to ask practical questions designed to test the candidate's ability to function competently as a beginning chiropractor. Within these parameters, the examiners are expected to use their professional judgment in selecting the particular questions to ask the candidate. Examiners are not provided with any specific questions that they are required to pose. The examiners are also expected to exercise their professional judgment in evaluating the candidate's answers to their questions. The grading of these answers therefore is a "subjective" process reflecting the examiners' opinions as to the quality of the candidate's answers. For each of the subject areas covered during the physical diagnosis portion of the practical examination, the candidate receives a separate grade from each of the two examiners conducting this portion of the examination. A 4 is the highest grade the candidate can receive from an examiner for a covered subject area. This grade is reserved for answers which reflect exceptional expertise in the subject area. A grade of 3 out of a possible 4 (or 75%) is to be given where no more than adequate expertise is demonstrated. Where the candidate's answers demonstrate expertise that is more than adequate but less than exceptional, a grade of 3.5 (or 87.5%) is to be given. Where the candidate, through his answers, displays inadequate expertise, depending on the extent of the inadequacy, either a grade of 2.5 (or 62.5%), 2.0 (or 50%), or 1.5 (or 37.5%), is to be awarded. The lowest possible score a candidate can receive from an examiner is a 1 (or 25%). This grade is warranted where the candidate's knowledge of the subject matter is so lacking as to present a danger to the public. The candidate's overall average score on the physical diagnosis portion of the practical examination is obtained by dividing the candidate's total number of grade points by two (representing the number of examiners) times the number of subject areas covered by the examiners. To pass this portion of the examination, the candidate's overall average score must be at least a 3 (or 75%). If the candidate fails to attain such a score and contends that the examiners unfairly or erroneously evaluated his performance, the videotape of this portion of the examination is reviewed by other chiropractic experts. Based on the recommendation of these experts, adjustments may be made to the candidate's score. Mathesie was tested on six subject areas on the physical diagnosis portion of the November 1988, examination: case history; general physical examination; orthopedic examination; neurological examination; x-ray technique and diagnosis; and laboratory diagnosis. He received a failing overall average grade from the two examiners of a 2.75 (or 68.75%). Following expert review, adjustments were made which raised Mathesie's overall average grade to a 2.875 (or 71.875%). This was still less, however, than the 3 (or 75%) he needed to pass. Mathesie was awarded a 3 by both examiners for his answers pertaining to case history. Both examiners' grades were subsequently increased to a 3.5 after expert review. Mathesie was asked by the examiners "the basic headings and things that [he] would be interested in having in the case history." In responding to the question, Mathesie mentioned that he would do a "general survey of their whole body," but he failed to specify that he would inquire about urinary incontinence or genital problems, specific inquiries that are routinely made by chiropractors. In view of Mathesie's failure to specifically mention these matters, it cannot be said that it was arbitrary or unreasonable to score his answer on case history no higher than a 3.5. Both examiners gave Mathesie a 2.5 for his performance on the general physical examination segment of the test. Neither of their grades was raised following expert review. On this part of the examination, Mathesie was asked to list "the vital signs." He responded, "blood pressure, pulse, respiration rate, and temperature and some sources add height and weight." Mathesie was then asked to take the blood pressure of one of the examiners, a man approaching 40 years of age. He did so and discovered that the examiner's blood pressure was 165 over 70, which Mathesie remarked "is very high blood pressure." When asked what he would tell a patient whose blood pressure remained at this level for three consecutive days, Mathesie replied that he would advise the patient that he "had an elevated blood pressure and that he should be seen by a medical doctor for further evaluation." Blood pressure of 165 over 70 is only slightly higher than normal for a man approaching 40 years of age. Contrary to what Mathesie indicated to the examiners, it is not "very high blood pressure" and, without more, is no cause for alarm. Accordingly, Mathesie's failure to receive a grade higher than a 2.5 on the general physical examination segment of the test was not without reason or logic. On the orthopedic examination segment of the test, Mathesie was awarded a 3.0 by both examiners. Expert review did not result in a change of either of these grades. On this segment of the test, Mathesie was asked to evaluate the right knee of one of the examiners. In conducting his evaluation, Mathesie failed to examine both knees, although during the next segment of the test he did indicate, with some prompting by the examiners, that he "would compare bilaterally all the orthopedic tests." Bilateral examination is a standard, routine chiropractic practice which assists the chiropractor in determining whether the patient has a developmental or pathological problem. Inasmuch as Mathesie did not conduct such a bilateral examination when asked to assess the condition of the examiner's knee, he did not deserve to receive a grade higher than a 3.0 on the orthopedic examination segment of the test. On the neurological examination segment of the test, Mathesie received a 2.5 from one examiner and a 3.0 from the other examiner. After expert review, the 2.5 grade was raised to a 3.0. No change was made to the other examiner's grade. During this segment of the test, Mathesie initially failed to perform the patella reflex test bilaterally as he should have. It was only after one of the examiners suggested that it was necessary to determine a patient's normal reflexive action that Mathesie indicated he would "compare bilaterally all the orthopedic tests, all the neurological tests and reflexes." Mathesie further stated on this segment of the test that, in attempting to neurologically assess the patient, he would administer a cardinal gaze examination during which he would have the patient cover one eye and follow his finger with the other eye. Although a cardinal gaze examination may be administered in this fashion, the better method is to have the patient follow the moving object with both eyes. In view of the foregoing, a 3.0 was not an unreasonably low grade to give Mathesie on the neurological examination segment of the test. Mathesie received a 3.0 from both examiners on the x-ray technique and diagnosis segment of the test. Neither grade was changed following expert review. Mathesie was asked on this segment of the test to "set up a right [anterior] oblique." In describing how he would do so, Mathesie failed to give information concerning the film size and central ray. Given these omissions, Mathesie's failure to receive a grade higher than a 3.0 on this segment of the test was not without justification. Mathesie received a 2.0 from one examiner and a 2.5 from the other examiner on the laboratory diagnosis segment of the test. No adjustments were made to either of these grades. On this segment of the examination, Mathesie was asked what conclusions he would reach concerning the condition of a patient based on the results of blood tests revealing a hemoglobin of 8, a hematocrit of 25, and a RBC of 3.5. As Mathesie should have been aware, such test results reflect that the patient has suffered a severe loss of blood and therefore requires immediate medical attention. Mathesie, however, did not immediately recognize the seriousness and urgency of the matter. Having failed to do so, he cannot persuasively argue that the grades he received on this segment of the examination were unreasonably low. After receiving notification that he had failed the physical diagnosis portion of the November 1988, licensure examination, Mathesie retook and passed the practical examination.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Chiropractic Examiners enter a final order dismissing Mathesie's challenge to the failing overall average grade he received on the physical diagnosis portion of the November 1988, licensure examination on the ground that such challenge is now moot. Should the Board decline to dismiss Mathesie's challenge on the ground of mootness, it is RECOMMENDED that the Board enter a final order rejecting such challenge as without merit and denying Mathesie the relief he has requested. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 19th day of September 1989. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division Administrative Hearings this 19th day of September, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 89-3255 The following are the Hearing Officer's specific rulings on the findings of fact proposed by the parties: Mathesie's Proposed Findings of Fact Accepted and incorporated in substance, but not necessarily repeated verbatim, in this Recommended Order. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. First sentence: Accepted and incorporated by reference; Second sentence: Rejected because it is more in the nature of legal argument than a finding of fact. Moreover, in order to be qualified as an expert witness in the field of chiropractic, Dr. Ordet did not have to meet the "continuous practice" requirement of Florida Administrative Code Rule 21D-11.007. To the extent that this proposed finding suggests that the Department failed to substantially comply with any prehearing discovery order issued by the Hearing Officer or that the Department otherwise engaged in improper conduct prejudical to Mathesie, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it is more in the nature of commentary on the quality of Ordet's testimony than a finding of fact. Furthermore, while it is true that Ordet's opinion regarding Mathesie's performance was necessarily subjective in nature, based on Ordet's credentials and qualifications, it appears that the opinion he gave was an informed and educated one, notwithstanding his failure to cite any specific authoritative writing supporting his opinion. First sentence: Accepted and incorporated by reference (It should be noted, however, that although Ordet "has been out of school [as a student] for many years," he is currently on the faculty of two chiropractic colleges); Second sentence: Rejected because it is more in the nature of commentary on the quality of Ordet's testimony than a finding of fact. Moreover, the Hearing Officer finds no persuasive support for the statement that Ordet "undoubtedly has not kept up with the advances in the chiropractic education." Accepted and incorporated in substance, except for the last two sentences, which have been rejected because they are not supported by persuasive competent substantial evidence. Accepted and incorporated in substance, except for the last sentence, which has been rejected because it is not supported by persuasive competent substantial evidence. Accepted and incorporated in substance. Accepted and incorporated in substance, except for the last two sentences, which have been rejected because they are not supported by persuasive competent substantial evidence. Rejected because it is not supported by persuasive competent substantial evidence. To the extent that this proposed finding suggests that Mathesie should not have had points taken off for indicating that he would tell a patient with a blood pressure reading of 165 over 70 to see a medical doctor, it has been rejected because it is not supported by persuasive competent substantial evidence. First sentence: Rejected because it constitutes a statement of the law rather than a finding of fact; Second sentence: Rejected because it is not supported by persuasive competent substantial evidence. Accepted and incorporated by reference. Rejected because it is not supported by persuasive competent substantial evidence. Accepted and incorporated in substance. (It should be noted, however, that although Mathesie did state "on the video that all tests would be done bilaterally," he made this statement following the orthopedic examination after one of the examiners suggested, through his questioning, that it was important to determine what was "normal" for the patient.) To the extent that this proposed finding suggests that Mathesie should have been awarded a grade higher than a 3.0 on the neurological examination segment of the test, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it is not supported by persuasive competent substantial evidence. To the extent that this proposed finding suggests that Mathesie should have been awarded a higher overall average grade on the physical diagnosis portion of the November, 1988, licensure examination than a 2.875 (or 71.875%), it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it is more in the nature of a request for relief than a finding of fact. Rejected because it is more in the nature of a request for relief than a finding of fact. The Department's Proposed Findings of Fact Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance, except to the extent that it indicates that "[c]ase history was raised to a 2.5 by both examiners." The uncontradicted evidence reveals that Mathesie originally received a 3.0 from both examiners on case history and that both of these grades were subsequently raised, following expert review, to a 3.5. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated by reference. COPIES FURNISHED: Michael W. Mathesie 8933 Northwest 51st Place Coral Springs, Florida 33067 E. Harper Field, Esquire Deputy General Counsel Department of Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 Pat Guilford Executive Director Board of Chiropractic Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact The Petitioner, David J. Pennell, is an applicant for licensure by examination to practice acupuncture in the State of Florida. The Petitioner took the acupuncture examination on July 18-20, 1986. He obtained a total overall grade of 68 on the practical portion of the test. A grade of 70 is required to pass the examination. The Petitioner challenges the grading of the answer he gave to the question requiring him to locate the acupuncture point Gallbladder 34. In order to demonstrate the point locations on the examination, applicants are given small round stickers which must be correctly placed on the body of a model. If the sticker is not placed at the correct acupuncture point, the answer is graded incorrect. The Petitioner's placement of the sticker at the acupuncture point Gallbladder 34 was graded incorrect. The Petitioner testified that he had observed his model consuming beer, and that as a result the model's hand was shaking and he was sweating profusely. Consequently, the Petitioner contends that it was difficult to keep the stickers identifying various points on the model's hand. In addition, the Petitioner testified that it took 15-20 minutes for an examiner to arrive at his examination room to grade this portion of the test. Thus, the Petitioner questions the grade he received on the location of the point for Gallbladder 34 because some of the stickers may have fallen off the model or their placement may have been altered. However, there is little evidence presented to support these contentions. For the most part, only speculation was offered by the Petitioner. Both of the Petitioner's witnesses unsuccessfully took the 1986 acupuncture examination with the Petitioner, but neither of them could testify that the models they used were the same model used by the Petitioner. They were also unable to corroborate any of the Petitioner's testimony regarding beer drinking by the model, or shaking or profuse sweating by the model. The Respondent's test development specialist acted as a monitor during the July, 1986, acupuncture examination. All of the monitors for this examination were available to the candidates continuously during the examination. The candidates had the option to go to another exam room if there was any problem. The Petitioner never made any complaint that his model was unsatisfactory. After the candidates finished the practical portion of the examination an examiner came in to grade it within 2-3 minutes. The temperature in the examination rooms was so cold that the models required blankets. The consumption of alcoholic beverages during the examination is prohibited, and no models were seen drinking anything but soft drinks. None of the monitors reported any such complaints. The Respondent's examiner testified similarly regarding the room temperature and the time it took examiners to enter the examination room. He did not observe any of the models drinking beer during the examination. Even if a model had been drinking beer, it would not affect a candidate's placement of the stickers unless a model's drinking caused him to fall off the table.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is RECOMMENDED that the Board of Acupuncture enter a Final Order dismissing the challenge to and request for review of the Petitioner's score on the July, 1986, practical portion of the acupuncture examination. THIS ORDER entered this 27th day of July, 1987 in Tallahassee, Leon County, Florida. WILLIAM B. THOMAS 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 27th day of July, 1987. COPIES FURNISHED: Mr. David J. Pennell 418 NE. River Drive Deerfield Beach, Florida 33441 Chester G. Senf, Esquire 130 North Monroe Street Tallahassee, Florida 32399-0750 Van Poole Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Joe Sole, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Marcelle Flanagan Executive Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
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 Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.
Findings Of Fact Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale. Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee. At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000. In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail. At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle. Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling. Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed. Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary. Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible. Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon. After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI. Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for review in accordance with Subsection 440.13(1)(m), Florida Statutes. AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code. Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner. Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him. AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes. The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint. The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks. Genzyme 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 in the wounded cartilage and covered with the periosteal flap. The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient. Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure. Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI. Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee. The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed. Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail. There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind. The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way. Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being. AHCA stipulates and the evidence establishes that ACI has been established to be safe. Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.
Recommendation Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner. DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS 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 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308
