Findings Of Fact Respondent, Santiago F. Suarez (Suarez), was at all times material hereto licensed as a physician in the State of Florida, and held license number ME 0030132. Suarez is a family practitioner, and has no specialized training relating to the human eye. He has never performed a refraction or prescribed eyeglasses during his medical career, nor has he had any training or experience in prescribing and fitting contact lenses.1 Commencing in the latter part of 1983 and continuing through the early part of 1984, Suarez acted as the supervising physician for Reynaldo Avello (Avello) when he performed refractions or fit contact lenses on clients of the Optical Medical Center; a business owned by Avello. During this time period, Avello routinely refracted the vision of his clients; measured the eyes of clients who desired contact lenses; prescribed eyeglasses and contact lenses; and prepared, dispensed or fit eyeglasses and contact lenses for his clients as well as clients of optometrists and ophthalmologists. Avello is not, and never has been, a licensed optician or optometrist, and he has no formal education or training beyond high school. Consequently, his activities were proscribed by law unless they were appropriately delegated and supervised by a medical doctor.2 Chapter 463 and 484, Part I, Florida Statutes. In this case Avello, not Suarez, prescribed eyeglasses and contact lenses. Avello conducted the eye examination, but limited his practice to refracting the eye and, when appropriate, to measuring the eye for contact lenses. Although Avello was ostensibly practicing under Suarez' supervision, Suarez was not competent to perform a refraction, or to prescribe and fit eyeglasses and contact lenses. In fact, Suarez took no active part when client's eyes were refracted, but deferred to Avello's "expertise." Suarez limited his involvement to securing a brief medical history from the client, and being available in case an emergency arose.3 Suarez' reliance on Avello's "expertise," without inquiring as to his training and experience, was a serious error in judgment. The only training Avello had in refracting the human eye occurred while he was employed part-time by the Union Latina clinic in Hialeah, immediately before he opened the Optical Medical Center. During his employment at the clinic, Avello was shown how to do a refraction by a board qualified ophthalmologist, but he never performed any refractions under that ophthalmologist's supervision. In March 1980, Avello opened the Optical Medical Center. With the exception of the period during which Suarez supervised Avello, the center has always had in its employ a board qualified or certified ophthalmologist. During those times, all eye examinations were performed by the ophthalmologist, and Avello did no refracting. While Avello considers himself qualified to do refracting, the proof regarding his training and experience renders his opinion unpersuasive. At no time was he shown to have worked under the supervision of a qualified practitioner, and no qualified practitioner was shown to be familiar with the quality of his work. Further, Avello was not shown to have had any qualified training or experience in measuring the human eye; prescribing eye glasses and contact lenses; or preparing, dispensing, and fitting eyeglasses and contact lenses. Accordingly, the proof established that Suarez accepted and performed professional responsibilities which he knew he was not competent to perform, that he assisted an unlicensed person to practice medicine contrary to law, and that he delegated professional responsibilities to a person he should have known was not qualified to perform them. The proof further established that the existent community standard required that a complete eye examination be performed before eyeglasses or contact lenses could be prescribed, and that such standard was breached. Suarez' failings could have resulted in profound adverse consequences to those patrons who were ostensibly refracted and fitted under his supervision. Improperly fit eyeglasses can result in blurred vision and nausea. More importantly, improperly fit contact lenses can result in permanent visual damage to the eye. In mitigation, Suarez avers that he agreed to supervise Avello out of a sense of personal obligation, not profit; that his employment was to be for the limited time it took Avello to secure the services of another physician; and, that when he undertook to supervise Avello he believed such activity to be legal. Suarez also offered for consideration in mitigation the fact that he cooperated in the investigation of the Optical Medical Center, and the fact that he had never previously been disciplined. Suarez' plea in mitigation is largely unpersuasive. While he may have undertaken Avello's supervision out of a sense of personal obligation, it was not without the expectation of compensation. Suarez and Avello had agreed, that if their association proved profitable, he would be compensated for his services. Notably, while Suarez' desire to fulfill a personal obligation is admirable, its priority is far below that owed to those to whom he professed to render a professional service. In this case, Suarez' supervision permitted an unqualified person to render professional services that he, as a medical doctor, was not qualified to perform, and therefore not qualified to supervise. No physician could reasonably believe such conduct was appropriate.4 Suarez' assertion that his association with Avello was to be of limited duration is not only irrelevant, but contrary to the proof. Suarez supervised Avello for 1 1/2 years, and there was no showing that Avello or Suarez made any effort during that period to hasten his replacement. Notably, during his association with Avello's business, the front of the store proclaimed in bold guilding "Optical Medical Center, Santiago F. Suarez, M.D." Under the circumstances, the proof does not suggest that their association was to be casual or of short duration.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that: The medical license of Respondent, Santiago F. Suarez, be suspended for a period of one (1) year, and that during the period of such suspension Respondent be required to complete such courses as the Board of Medicine may require to demonstrate an adequate comprehension of professional ethics, scope of practice for a family practitioner and delegation of professional responsibility; and An administrative fine in the sum of $2,000.00 be ~ assessed against Respondent, Santiago F. Suarez. DONE and ORDERED this 15th day of September, 1987, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of September, 1987.
The Issue The issue for consideration in this case is whether Respondent's license as an optometrist in Florida should be disciplined because of the matters alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the issues herein, the Petitioner, Board of Optometry, was responsible for the licensing of optometrists and the regulation of the practice of optometry in this state. Respondent was licensed as an optometrist in Florida, practicing under license number OP0001451, originally issued on September 21, 1978. Some time prior to or during 1987, Respondent, Dr. Brian L. Weber, dissatisfied with what he found to be the practice of large optical dispensers with regard to pressuring optometrists to prescribe lenses, decided to open a facility where patients needing glasses could receive an eye examination from a licensed optometrist and also, if the patient so desired, obtain the eye wear prescribed. Consistent with what he perceived to be the rules of the Board of Optometry at that time, Dr. Weber entered into a business venture with Mr. Record, a licensed optician, through which a patient could do just that. In 1990, Dr. Weber and Mr. Record changed the name of the business to 29/49 Optical, Inc., and as of March 2, 1990, operated five separate stores under that name. Dr. Weber and Mr. Record incorporated the company within which each ultimately owned 50 percent of the stock of the corporation. Dr. Weber provided the funds to start the business, and Mr. Record, the "sweat equity." Mr. Record was made president of the company because he had the experience in opticianry and was responsible for operations. Weber was the "money man," and provided the overall business goals and strategy. Once the corporation was established and the initial filing was completed, Mr. Record was responsible for recurring filings as a matter of course. The firm, 29/49 Optical, Inc., was in the business of providing optician services. The leases for the stores were taken out in the name of the company which, in essence, provided a "turn-key" office to a licensed optometrist who was one of those individuals associated with Respondent in the optometry practice known as Brian L. Weber and Associates. Each of the optometrists in the association was an independent contractor, associated in practice with Respondent. None of them were employees of 29/49 Optical, Inc. In each of the offices of 29/49 Optical, Inc., was a display area where glass frames were displayed and fitted, a waiting room used both by customers of the optical shop and patients of the resident optometrist, a storage room, and, for the exclusive use of an optometrist, an examining room equipped with those items and supplies necessary for the accomplishment of eye examinations. As was the custom in the profession at the time, this office, owned or leased by 29/49 Optical, Inc., was furnished to the optometrist at little or no cost. Though it was hoped that the optometry patients would choose to have their prescriptions for glasses or contact lenses filled at 29/49 Optical, Inc., they were under no obligation to do so, and many did not. Patients seen by an optometrist in the 29/49 Optical, Inc. offices were billed by the optometrist for the optometry services and by the optical company for the cost of any glasses or contact lenses purchased. The two charges were paid separately, the payments placed in separate accounts. Payments for eye examinations by an optometrist were deposited to the account of Brian L. Weber, optometrist. Payments for glasses or lenses were deposited to the accounts of 29/49 Optical, Inc. The funds were neither mixed nor co-mingled, and funds placed in the account of Brian L. Weber were not used to pay the expenses of the 29/49 Optical, Inc. stores. Each optometrist maintained his or her own patient records which were stored in a filing cabinet maintained for that purpose separate and apart from the files relating to the operation of the 29/49 Optical, Inc. stores. Only the optometrists made entries to those records. Since the optometrists who manned the offices in the 29/49 Optical, Inc., stores were independent contractors, within basic guidelines as to routine procedures and office hours, they were free to work such hours as they chose and to charge what they believed to be appropriate fees for other than routine procedures. They were paid with funds drawn from the account of Brian L. Weber, into which the patient fees for optometry services were deposited. In addition to the associates who practiced at the individual shops, Dr. Weber also practiced at each and all of the shops periodically. Mr. Record was paid from the checking account maintained by 29/49 Optical, Inc., on which account either Record or the Respondent could write checks. Dr. Weber is quick to admit that the advertisement for 29/49 Optical, Inc., which appeared in the March 1, 1990, edition of the St. Petersburg Times is a poorly worded advertisement. So much of the advertisement which implies a total price to be paid to 29/49 which includes examination and glasses is admittedly inappropriate, and when he saw the proof prior to publication, he claims to have made appropriate changes which would have corrected the deficiencies. However, the corrections dictated by Respondent were not made, and the inappropriate advertisement was published. His immediate complaint to the newspaper after the first publication date resulted in an immediate correction. Respondent claims that when the disciplinary action was initiated against him in 1992, he immediately contacted the newspaper and requested a letter which would clarify the situation. He did not tell the paper what to say, and the subsequent letter from the paper relates to a failure to have his name appear in the March 1, 1990, advertisement. This is not the defect in the advertisement of which the Board complains. Dr. Liane, a Board certified optometric physician, a former Chairman of the Board of Optometry and now an expert for and consultant to the Board, reviewed the case file in this matter for the Board, along with the transcripts of other cases relating to Dr. Weber. None of the other matters was based on disciplinary action. To his recollection, the Board's rule on corporate practice was promulgated in 1986, at the time he was a member of the Board. At that time, the Board conducted numerous workshops around the state to advice practitioners of the standard of practice in that regard. Dr. Liane was also on the Board's legislative committee when Chapter 463, Florida Statutes, was enacted. The Board of Optometry was concerned with the protection of the public from the danger of allowing opticians or unlicensed entities to have input into whether lenses were needed. The Board, and the legislature, wanted to allow optometrists to practice with other licensed health care practitioners, but not with unlicensed opticians. After the legislation was passed, the Board promulgated its Rule 21O-3.008, which outlines factors which must be shown in order to prove corporate practice. One of the prohibitions in the rule relates to any practice or pronouncement which "implies" that the corporate or unlicensed entity is providing professional services. In the instant case, Dr. Liane is of the opinion that the original advertisement in question implies that 29/49 Optical, Inc., is offering a complete eye examination. As was noted previously, Respondent agrees, and it is so found. Having considered all the evidence available to him, including the advertisement of March 2, 1990, and the assumption of the lease arrangements existing prior and up to 1990, Dr. Liane concluded that Respondent was involved in an unauthorized corporate practice. While a side-by side practice between optometrists and opticians is common and approved, it may not be within a corporate practice by the same individuals who are in business together.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Board of Optometry enter a Final Order dismissing Counts I and II of the Administrative Complaint; finding him guilty of Count III thereof and imposing an administrative fine of $250.00. DONE AND ENTERED this 3rd day of November, 1997, in Tallahassee, Leon County, Florida. ARNOLD H. POLLOCK Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6947 Filed with the Clerk of the Division of Administrative Hearings this 3rd day of November, 1997. COPIES FURNISHED: Alexandria E. Walters, Esquire William C. Childers, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Angela T. Hall Agency Clerk Department of Health 1317 Winewood Boulevard Building 6 Tallahassee, Florida 32399-0700 Grover Freeman, Esquire 201 East Kennedy Boulevard Suite 1950 Tampa, Florida 33602 Eric G. Walker Executive Director Board of Optometry 1940 North Monroe Street Tallahassee, Florida 32399-0792 Pete Peterson General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102-E Tallahassee, Florida 32399-0700
Findings Of Fact The Respondent is a licensed medical doctor holding license number MEOO17343 issued by the Florida Board of Medical Examiners. He has a general family practice but also states that he specializes in neurology as well. He is not board certified in any specialty. He has had many years of practical medical experience in Cuba and later in the United States. The Petitioner is an agency of the State of Florida charged with regulating and enforcing licensure and the licensure standards for medical doctors in Florida, and enforcing the practice standards embodied in Chapter 458, Florida Statutes. In October, 1981, the Respondent employed Manuel Farinas to work in his medical office, specifically for the purpose of performing eye examinations and writing prescriptions for eyeglasses. The Respondent had known Manuel Farinas when they were in Cuba and knew that he had experience also in working with contact lenses and fitting contact lenses and eyeglasses. The Respondent was aware that Farinas did not hold a license to practice any of the medical or healing arts in Florida, but was informed by Farinas that he was then studying to take the foreign medical graduate examination which is a prerequisite to licensure. The Respondent set up a separate eye examination room in his medical offices which contained equipment designed specifically to perform eye examinations. Indeed, as established by Petitioner's composite Exhibit 7, Manuel Farinas has not been and is not licensed as a physician or physician's assistant in Florida and holds no license in Florida authorizing practice of medicine in any form. On March 16, 1982, Dorris B. Bruce, an investigator for the Department of Professional Regulation, went to the Respondent's office to obtain an eye examination. Patient Bruce was examined by Mr. Farinas and was diagnosed as having "hypertension retinopathy." The examination of the "patient" consisted of a cornea examination, an examination for conjunctivitis, the patient's lenses were checked, and a fundus examination was performed. The patient was given a prescription for eyeglasses on the Respondent's prescription blank, which bore his printed name. The blank was unsigned and Respondent's testimony itself establishes that the examination of patient Bruce and the rendering of the prescription for eyeglasses was done exclusively by Manuel Farinas, and Respondent did not examine Dorris Bruce nor supervise the medical care provided by Farinas. Robert Wolf, an investigator employed with the Department, made an appointment for an eye examination with the Eyeglass Emporium for June 1, 1982. This is a business establishment and opticinary owned by one Geoffrey Hullman. It is located next door to, and in the same building with, the Respondent's medical office. Upon arriving at the Eyeglass Emporium, Mr. Wolf was directed to the Respondent's adjoining medical office where the "patient" completed a patient information form. Mr. Wolf was then taken by one of Respondent's office assistants to the examining room for the eye examination mentioned above. Shortly thereafter, an office assistant entered the room accompanied by a man who was introduced as the doctor who would perform the eye examination. The "doctor" was actually Manuel Farinas. Notations in the medical record prepared on patient Wolf at the Respondent's office (Exhibit 3 in evidence) establish that the patient had a visual eye examination without glasses and was examined for conjunctivitis and also had cornea, lens and fundus examinations. Farinas examined Mr. Wolf by shining a flashlight type device into his eyes, having him read a wall chart, and by having him look through a lens in a machine that flashed charts on the wall until Farinas got the best subjective reading of visual acuity from the patient. The patient was also given a chart to read. Farinas diagnosed the patient as having a mild case of conjunctivitis and gave him a prescription for eyeglasses and a prescription for Vicollirum. Both prescriptions were written on blanks bearing the Respondent's name and office address. Upon completion of the eye examination, the prescriptions were written by Manuel Farinas for patient Wolf and were placed in a folder and given to the patient. The prescriptions were not signed by either Farinas or the Respondent. At no time during the patient's presence in the Respondent's office, did the Respondent either examine the patient or review and approve the medical prescriptions written for the patient, or supervise the medical examination activities of Farinas. The patient was then directed by Farinas through a door adjoining the Respondent's office to the Eyeglass Emporium to have the prescription for eyeglasses filled. Investigators for the Petitioner then re-entered the Respondent's office at that time and interviewed Farinas who was still in the room where the patient Wolf had been examined. After identifying themselves as investigators for Petitioner, Farinas was asked for identification. He identified himself as Dr. Manuel Farinas and admitted that he had written the prescriptions for patient Wolf. Respondent entered the room at that point and the Petitioner's employees identified themselves as investigators. In the presence of the Respondent, the investigator elicited statements from Farinas that he had examined patient Wolf and that he had written the two prescriptions for that patient as well as eliciting the statement that he was not licensed. The Respondent did not comment on any of those responses by Farinas at that time. Farinas then produced for Petitioner's investigators documents purporting to show that he had received medical training in Cuba. The Petitioner established through expert testimony of Dr. Lawrence T. Reese, who is a board certified opthalmologist, with a sub-specialty in retinal muscular disease, that a medical doctor does not receive the appropriate training in a general M.D. degree course of study to qualify him to either perform a thorough eye examination or to prescribe eye-wear for patients. Dr. Reese practices in Dade County, Florida and is affiliated with Parkway Regional Medical Center and Humana Hospital. He holds a voluntary faculty appointment at the University of Miami School of Medicine in Opthalmology. Dr. Reese is aware of the general standard of instruction in opthalmology in a medical school curriculum for the general M.D. degree granting institutions. This instruction, consists of from three to four hours of instruction, and is basically a laboratory study where the medical students examine each others' eyes. Thus, the general medical student who fails to pursue a specialty in opthalmology, receives only a bare minimum amount of training in patient eyecare and examination. A general or family practitioner would thus only have minimal involvement in the area of eye-care. Dr. Reese is aware of the generally prevailing standard of care of general practitioners in Dade County, Florida. Dr. Reese thus established that the extent of eye-care provided by general practitioners in that medical community is to visually look into the patient's eyes as a part of a general medical examination. This is a cursory eye examination at best. The visual examination consists of looking into the patient's eyes with an opthalomoscope in order to get a view of the optic nerves and surrounding fundus. If such a general practitioner/family practitioner examination shows that the patient's eyes appear to be normal, this is the extent of the visual examination performed. If problems are apparent, the general prevailing standard of practice dictates that the general practitioner or family practitioner refer the patient to a board certified opthalmologist. John Handwerker, M.D., is a licensed medical doctor in the State of Florida who has practiced medicine in Dade County for 33 years. His testimony corroborates that of Dr. Reese. Dr. Handwerker is not aware of any eye-care training provided by medical schools in M.D. degree granting programs. He is aware of the generally accepted prevailing standards of practice of medicine by general and family practitioners in Dade County and established that a family practitioner would not typically perform a refraction of the eyes for the purpose of prescribing eyeglasses. That standard would be the same for a general practitioner even if he has a sub-specialty in neurology, which is not a relevant sub-specialty to questions of eye-care. This type of practitioner would not have either the training or experience to perform such an examination. As established by both of these expert witnesses, a person who takes a patient's history, makes an examination of the patient's eyes and prescribes either medication or an optical lens or both, is engaged in the practice of medicine. Both medical experts established that if a licensed medical doctor authorizes an unlicensed person to take the medical history of a patient, perform the eye examination and write prescriptions for medication, or for optical lenses for that patient, and the extent of the licensee's participation in the process is either to merely sign the prescription or at most to review the patient's medical records, then that licensed medical doctor is not properly supervising an unlicensed person and is permitting an unlicensed person to practice medicine. As established by Dr. Reese, a thorough eye examination would consist of determining if the patient has a family history of eye disease, determining whether the patient is experiencing any particular visual problem, determining the refractive state of the patient's eyes (that is, visual acuity), and would include a check of various eye systems of the patient, such as the pupils and their reaction to light as well as the ocular motor system for eye movement (musculature). Additionally, a properly examined patient, should be checked for visual defects, have a slit lamp examination to determine the medical condition of the eyes (which consists of examining the upper and lower parts of the pupils under the eyelids), the patient's cornea should be checked for material in the eye fluid and in most instances a dilated examination of the pupil should be done to diagnose its condition. When all of these examinations and checks are performed the doctor can then reach a cogent conclusion concerning the overall health of the patient's eyes and make appropriate recommendations concerning care and treatment. A medical diagnosis that a patient's fundus is normal, cornea is normal and the lens is normal can only be made if the patient's eyes have been dilated. The fundus can be examined without dilating the patient's eyes, although dilation would give increased ability to examine it. Dilation of a patient's eyes is effected by the use of a prescription drug by medical practitioners who are experienced and who practice in the area of eye examinations and eye-care. Both patients Bruce and Wolf were diagnosed by Farinas as having normal fundus, cornea and lenses. But this diagnosis was made without a thorough eye examination because Farinas did not dilate their eyes to adequately check these systems. Although it is true that ready-made eyeglasses can be purchased at commercial department stores with or without a prescription, where a patient has visited a medical doctor's office and had his eyes examined and is given a written prescription for glasses, the patient then believes that he has received a proper, competent medical eye examination and is being prescribed glasses for valid medical reasons. Where an inadequately trained or unlicensed person performs visual examinations and writes medical prescriptions for glasses, a patient is being deceived or at least potentially deceived as to the correct assessment of the condition of his eyes. The testimony of the Respondent himself as well as Mr. Hullman, the operator of the Eyeglass Emporium, establishes that Farinas was known and referred to as "Dr. Farinas" during the time he was employed in Respondent's office. Farinas was introduced to Mr. Wolf as "Dr. Farinas" at a time when he was not (and still is not) licensed in Florida. Both Drs. Reese and Handwerker opined that where a general practitioner with a specialty in neurology permits an unlicensed person to conduct medical examinations and write medical prescriptions for eyeglasses or for medicinal drugs, and the extent of the licensee's contact with the patient is to sign prescriptions or review the patient's medical records, the licensee has failed to conform to generally accepted and prevailing standards of care recognized by reasonably prudent similar physicians under similar conditions and circumstances. The Respondent is not board certified in opthalmology and has had no residency training or other formal training in opthalmology outside the minimal general training described above, received in the course of preparing for his M.D. degree. The Respondent maintained that he has extensive experience performing medical visual examinations, but this testimony is not deemed credible because, as revealed by Petitioner's Exhibit 8 in evidence, during the informal proceeding before the Board where Respondent was also testifying under oath, he acknowledged that he had not performed medical visual examinations or refractions and had not written a medical prescription for eyeglasses in over 13 years, thus, his testimony that he has had extensive experience in performing medical visual examinations recently and during the period under consideration in the Administrative Complaint is not deemed credible. Although Respondent contends that he supervised the practice of Farinas, his testimony conflicts with competent evidence indicating otherwise. The supervision consisted of the Respondent allegedly reviewing the patient's records and signing prescriptions for eyeglasses or drugs written by Farinas. Although expert testimony has established that this does not constitute adequate supervision by a licensed medical doctor, in the case of both patients involved in this proceeding the eyeglass prescriptions were actually never signed. Although use of unsigned prescriptions is not necessarily illegal, it shows that Farinas was not supervised to any significant extent at all in his examination, care and treatment of patients who presented themselves to the Respondent's office for an eye examination. When patient Wolf was in the Respondent's office he was never examined by Respondent, nor was his prescription given him by Farinas ever reviewed by the Respondent, nor did the Respondent review his medical history, which he had provided in writing on a form provided by Respondent's office. Additionally, as established by witness Hullman, that witness returned unsigned prescriptions to the Respondent's office for the Respondent to sign after the prescriptions had already been filled by the opticianry and after the investigation into this matter had commenced. The Respondent signed the previously unsigned prescriptions and returned them to Hullman and thus it is established that at the time the prescriptions were executed and filled, the Respondent did not supervise the prescribing by Farinas nor the examinations to which the prescriptions related, both as to prescriptions of eyeglasses or drugs. Finally, it should be pointed out that Respondent was aware in April of 1982 that his use of Farinas in performing visual examinations and prescriptions as to eye-care patients was improper because of the visit to his office by Investigator Dorris Bruce. Two months later, however, patient Wolf went to the Respondent's office for an eye examination and was also examined by Farinas and tendered prescriptions by Farinas with no signature, supervision or other review of the procedure performed or prescriptions given by the Respondent. This was some nine months after Farinas first became employed in these capacities at the Respondent's office.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore RECOMMENDED: That a Final Order be entered finding the Respondent, Orlando C. Ramos, M.D., guilty, as charged in the Amended Administrative Complaint, of violations of Section 458.331(1)(g), Florida Statutes (1981); Section 453.331(1)(w), Florida Statutes, (1981), as well as a violation of Section 458.331(1)(t), Florida Statutes (1981), and that a fine of $2,000 be imposed and the Respondent's license to practice medicine be suspended for a period of three months. It is further recommended that the Respondent's licensure status be probationary for a one year period commencing at the conclusion of the three month's suspension, during which such probationary period his medical practice should be monitored by the Petitioner to ensure that such violations of the Medical Practice Act do not recur. DONE and ENTERED this 21st day of November, 1984, in Tallahassee, Florida. P. MICHAEL RUFF Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 21st day of November, 1984.
The Issue At issue is whether Respondent materially failed to follow applicable ruling making procedures required by Section 120.54(2)(a), Florida Statutes, with regard to promulgation of proposed Rule 21P-16.002, Florida Administrative Code, relating toqualifications of sponsors for apprentice opticians; whether the proposed rule is an invalid exercise of delegated authority by Respondent; and whether Petitioners are parties substantially affected by the proposed rule.
Findings Of Fact Respondent is the state agency responsible for regulation of an apprenticeship program for candidates desiring licensure as opticians in the State of Florida. The apprenticeship program provides an alternate route to qualification to take the examination for licensure as an optician. Candidates may also qualify for examination by receipt of an associate degree in opticianry from an accredited educational institution or previous practice and licensure in other jurisdictions. Candidates electing to pursue licensure examination through the apprenticeship program as currently established must comply with provisions of Rule 21P-16.002, Florida Administrative Code. The current version of Rule 21P-16.002, Florida Administrative Code, states: 21P-16.002 Qualifications for Apprentices and Sponsors. Apprentices and sponsors for apprenticeship programs must meet the following qualifications: An apprentice must be at least 17 years old at the date of application; must submit a complete application for apprenticeship along with proof of having obtained a qualified sponsor; and must submit the registration fee required in Rule 21P-11.013. A sponsor must be an optician, a physician or an optometrist licensed in this state, whose license is not subject to any current disciplinary action; must be actively engaged in the practice of the qualifying profession; and must provide the equipment set forth in Rule 21P-10.007 on the premises of any establishment in which apprentices are trained. Proposed Rule 21P-16.002, makes no changes to the existing sponsorship requirements found in paragraphs (1) and (2) of the present rule, but adds a new paragraph (3) which specifies the following: (3) No optician, physician or optometrist may serve as a sponsor unless he actually dispenses eyewear and maintains the required equipment on the same premises where the apprentice works. For example, an optician, physician or optometrist whose premises and equipment are distinct from the intended apprentice's work area cannot serve as a sponsor, even though the optician's, physician's or optometrist's premises are within the same office area or building. The proposed rule seeks to implement Section 484.007(1)(d)4., Florida Statutes, which provides an applicant may qualify to take the state opticianry licensure examination following completion of a three year apprenticeship "under the supervision of an optician, a physician, or an optometrist licensed under the laws of this state." Through promulgation of the new rule, Respondent seeks to correct a perceived deficiency in the degree of supervision provided by some sponsors to their apprentice opticians. The new proposed rule seeks to correct such deficiency through the prohibition of separate or "distinct" work areas for sponsor and apprentice; the requirement that the sponsor "dispense eyewear"; and the requirement for the sponsor to "maintain the equipment" used by the apprentice on the premises where both apprentice and sponsor work. Petitioners are corporate entities licensed to do business in the State of Florida. Petitioners operate various retail optical establishments engaged in providing opticianry services. While not licensed to perform opticianry services, Petitioners employ opticians and apprentice opticians for that purpose. Petitioners also have contractual relationships with licensed optometrists for the provision of optometric services at Petitioners' retail establishments. The employed opticians and contracted optometrists often act as sponsors for apprentice opticians employed in Petitioners' retail establishments. Generally, Petitioners' retail establishments haveseparated areas for optometry services, dispensing of eye wear and a laboratory for the preparation of lenses. In the various establishments, these areas are separated from each other by a permanent wall constructed of either glass or other solid, opaque substance. Two to four licensed opticians are employed in each of Petitioners' retail establishments. Each of these individual opticians, or a licensed optometrist under contract, may sponsor an apprentice optician employed by Petitioners. Often the sponsoring professional is otherwise occupied in these establishments and the apprentice, who is also generally an employee, may be required to perform certain functions without direct supervision by the sponsor. The proposed rule's requirement that a sponsor actually "dispense eyewear" results from Respondent's position that a sponsor should actually be performing that task in order to properly train an apprentice in the performance of that procedure. The proposed rule's requirement that a sponsor "maintains the required equipment on the same premises where the apprentice works" dictates that a sponsor must own the equipment used by the apprentice or otherwise be responsible for the provision of that equipment. Such a requirement may effectively prohibit opticians and optometrists employed by Petitioner from serving as sponsors where those employees do not own and are not otherwise responsible for providing, generally, the "required equipment" on the premises of Petitioners' various establishments. Petitioners argue that such de facto denial of sponsorship opportunities to opticians, optomertrists and physicians employed by them contravenes the statutory provision of Section 484.007(1)(d)4, Florida Statutes, that an apprenticeship be completed under the supervision of "an optician, a physician, or optomertrist licensed under the laws of this state." Such an argument is not credited in the absence of expressed legislative intent to grant sponsorship status to any of the licensed professionals denominated in the statute. Specifically, it is found that the referenced statutory provision sets a minimum requirement for sponsorship, as opposed to a limitation to establishment of further qualifications. Respondent's economic impact statement was prepared by counsel. Respondent's position, as expressed through testimony of its executive director, is that the proposed rule has no discernible direct adverse economic impact, although testimony presented by Petitioners supports the finding that the proposed rule change shall require at least some alteration of the physical arrangement at some of Petitioners' retail establishments in the event that Petitioners desire to continue present apprentice programs in their businesses.
The Issue The charges against Dr. Morton J. Schomer allege the following factual violations: Failure to display his license at the location of his practice of optometry; Failure to have an entry sign at the location of his practice indicating he was an optometrist practicing optometry; Failure to have all equipment required in the office where he engaged in the practice of optometry; and Failure to perform all tests and record the results as required for two patients, Edward Leswing and Steven Bachen. Dr. Schomer was afforded the opportunity by the Board of Optometry for an informal conference to discuss the allegations. This conference was conducted. Dr. Schomer requested the Board for a formal hearing, and the matter was referred to the Division of Administrative Hearings to conduct a hearing pursuant to Section 120.57, Florida Statutes. Prior to the formal hearing the Respondent moved to dismiss the proceedings and in support thereof asserted factual matters contrary to those alleged in the Administrative Complaint. Respondent asserted that he was working for Dr. Ortelio Olazabal, was under the doctor's control and supervision, and was not engaged in the practice of optometry. Therefore, Respondent asserted that he was not required to display his license or to have an entry sign, and the Board lacked jurisdiction over because his practice with Dr. Olazabal was governed by Chapter 458, Florida Statutes, Medical Practice Act. This motion presented what were essentially affirmative defenses. The motion was denied by an order dated November 19, 1980. Respondent was afforded the opportunity to present evidence in support of his factual assertions at the formal hearing. Respondent also moved for a continuance. This motion was also denied by the order mentioned above. Respondent moved for an order in aid of discovery. The order cited above provided specific dates for the parties to complete various portions of prehoaring discovery and disclosure. The parties were able to comply with the schedule established, and the formal hearing was begun on December 12, 1980. The hearing could not be completed on that date and was continued on February 25, 1981, after which the parties stipulated to submit proposed findings within 30 days. Motions for Directed Verdict by Respondent were made and denied at the close of Petitioner's case and at the conclusion of the hearing. Proposed findings of fact were filed by Respondent. Petitioner did not file proposed findings. The Hearing Officer has read the proposed findings of fact submitted by the Respondent. To the extent that the following Findings of Fact do not contain the proposed findings, they have been rejected as not being relevant to the issues or not being based upon evidence adduced at the hearing, or as being inconsistent with evidence which the Hearing Officer deems more credible.
Findings Of Fact Counts I, II and V Dr. Morton J. Schomer is an optometrist licensed by the Florida Board of Optometry for approximately the past five years. Until just prior to November, 1979, he was a practicing optometrist in Ohio. At that time he moved to Hallandale, Florida. Dr. Schomer responded to a newspaper advertisement by Dr. Ortelio Olazabal and was hired by Dr. Olazabal to work as an optometrist at 518 NE 167th Street, North Miami, Florida. Dr. Schomer practiced optometry at that address three days per week from late November, 1979, until February, 1980. During that time Dr. Schomer did not have his Florida license displayed and did not have an entry sign at that address indicating he was engaged in optometric practice. (Transcript, Volume II; December 12, 1380 - Page 236.) Count III In January of 1980, Dr. Schomer examined Edward Leswing, a 57-year-old male who is an investigator for the Department of Professional Regulation. Dr. Schomer used a keratometer and phoropter to examine Leswing's eyes together with a projector and eye charts. Dr. Schomer asked Leswing about his health and conducted a field test (Transcript, supra - Pages 242 and 254). Dr. Schomer prescribed soft contact lenses and reading glasses for Leswing based on this examination. Dr. Schomer accurately recorded or caused to be recorded the results of the examinations conducted and pertinent personal data. Dr. Schomer did not use a tonometer or retinoscope or perform an unaided visual acuity test on Leswing. (See Leswing's testimony and Dr. Michael Kondell's comments on Leswing's record, Dr. Kondell's Deposition - Pages 39 and 40.) In the opinion of Dr. Michael Kendell (Deposition - Page 59) Dr. Schomer's examination was insufficient to prescribe soft contact lenses for Leswing. Dr. Kondell is a physician specializing in ophthalmology. He is board eligible and is accepted as an expert in diseases of the eye and their treatment, and the examination of the eye for prescribing contact lenses and glasses. Count IV At the time Leswing was examined, Dr. Schomer used a keratemeter, a phoropter, and projector and eye charts, and these items were present in the office (Transcript, Volume II; December 12, 1980 - Pages 238 and 239). Dr. Schomer used his hands to conduct a field test (Transcript, supra - Page 254). At the time Leswing was conducting a covert investigation and did not ask Dr. Schomer to produce or identify any of the equipment present in the office. Dr. Schomer kept his hand-held equipment in a wooden box which he covered with a clipboard. Count VI Steven Bachen, a 14-year-old male, was seen by Dr. Schomer during January, 1980. Dr. Schomer accurately recorded or caused to be recorded the results of his examination of Bachen and his pertinent personal data. Dr. Schomer performed a keratometric and retinoscopic examination of Steven Bachen. (See Petitioner's Exhibit 12 and Deposition of Dr. Michael Kondell - Pages 36 through 38.) Dr. Schomer also used a phoropter to examine Steven Bachen's eyes (Transcript, Volume II; December 12, 1980 - Page 157). Dr. Schomer prescribed soft contact lenses for Bachen as a result of this examination. In the opinion of Dr. Kondell, Dr. Schomer's examination was sufficient to prescribe soft contact lenses for Steven Bachen (see Dr. Michael Kondell's Deposition - Pages 43 and 58). Count VII During the examination of Steven Bachen, Dr. Schomer used a phoropter, keratometer, projector and charts, and retinoscope. These items were present in the office. Count VIII At the time Dr. Schomer examined Steven Bachen he conducted a keratometric examination of Bachen. Bachen's glasses were removed when this examination was performed. Count IX No evidence was introduced concerning prior violations of Chapter 463, Florida Statutes, by Dr. Schomer. The only evidence presented of violations of Chapter 463, supra, was with regard to Counts I through VIII above.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law thee Hearing Officer recommends that Dr. Morton J. Schomer receive a letter of reprimand and be placed on probation for a period of one year, during which time his premises and records will be subject to examination by the Board of Optometry to ensure that he is in compliance with all applicable statutes and rules. DONE and ORDERED this 1st day of May, 1981, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, 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 1st day of May, 1981. COPIES FURNISHED: Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Michael B. Udell, Esquire 2020 NE 163rd Street, Suite 204 North Miami Beach, Florida 33162 Nancy Kelley Wittenberg, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether petitioner should have been awarded a passing grade on the clinical portion of the September 1990 optometry licensure examination?
Findings Of Fact As instructed, petitioner reported for the clinical portion of his optometry licensure examination with his own retinoscope. But the patient he brought with him was not suitable (as a subject for another candidate) because neither of her eyes had spherical objective and subjective error cali- brated in minus cylinder form within +6.0D to -6.0D and . . . an astigmatic correction objectively and subjectively within +0.75 to +4.0D or -0.75 to -4.0D. Respondent's Exhibit No. 1. Once this was discovered, petitioner left the examination site, recruited another patient, and returned in time to take the examination with a group of about ten other applicants. An information pamphlet explained beforehand what the candidates would be asked to do during the clinical examination: . . . You will be allowed 35 minutes to com- plete this section. Two licensed optometrists will independently observe and grade you. You may conduct the specified procedures in any appropriate order. A blank sheet of paper will be provided to you to record the results of your examination. You are allowed a brief period of time to make notes on the blank sheet of paper before you enter the examination room. Tests should be done on both eyes (including dilated eye). Points will be assigned according to the criteria listed below: Patient History (5 points) Chief complaint Personal medical history Personal ocular history Family medical history Family ocular history Follow-up Information (7 points) Follow-up as necessary on the above criteria. Visual Acuity (2 points) Pupillary Examination (6 points) Pupil size Direct and consensual response to light Afferent Pupillary Reflex Confrontation Fields Test (4 points) Confrontation Fields test should be done as described in Duane, J.D. Clinical Ophthal- mology, Harper and Row. Extra-ocular muscle balance (4 points) Versions Distance cover test Objective examination (retinoscopy) (8 points) Note: Points will be assigned on the basis of a comparison to the range obtained by licensed optometrists. Subjective refraction (12 points) Note: Points will be assigned on the basis of a comparison to the range obtained by licensed optometrists. In the second section, you will examine your own patient's eyes. This portion will be graded by examiners different from the exam- iners of Section 1. They will give you direc- tions and request certain views of the eye or ask for information as observe your performance through a teaching arm on the slit lamp or a teaching mirror on the BIO. They will assign grades independently. You will be asked to do the following procedures according to the specified criteria: Binocular indirect ophthalmoscopy (15 points) Accurately views and evaluates retinal land- marks as requested. Five points will be given for each of the three areas. Note: Patient will be in reclined position during this pro- cedure. We will supply a Keeler BIO headset. However, you will be allowed to use your own BIO if it has attached teaching mirrors. Biomicroscopy (anterior segment) (16 points) Demonstrates requested view of anterior struc- tures of the eye. Four points each will be given for performance related to: Cornea Anterior chamber Lens Anterior vitreous Goldman[n] tonometry (5 points) Accurately measures intra-ocular pressure. Biomicroscopy (posterior segment) (8 points) Accurately views and evaluates posterior pole landmarks as requested with two points each for four designated areas. Note: The Zeiss slit lamps are equipped with Hruby lenses. If you prefer a fundus contact lens, or a 90 diopter lens, you must provide your own lens. Gonioscopy (8 points) Accurately views and evaluates angle structure. To protect the patient, 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 instructions from the examiner and will continue until you notify the examiner to grade the procedure. Respondent's Exhibit No. 1. After petitioner's return with a patient whose eyes met the examiners' criteria, he was tested in the manner the candidate information booklet had described, which is the same procedure that has been followed since 1986. Refractions Robert Roos, a 43-year-old compound myopic astigmatic (who was assigned the number 079), was the patient it fell to petitioner to examine in section one. Before petitioner saw Mr. Roos, three licensed optometrists independently evaluated Roos' eyes. After objective refraction or retinoscopy of his right eye, they recorded astigmatic orientation or axis values of 110o, 115o and 116o, spherical values of -2.75, -2.5 and -1.75 diopters, and cyllindrical values of - 1.0, -1.75 and -1.75 diopters. Their subjective examination of the same eye yielded axis values of 107o, 110o and 111o, spherical values of -2.25, -2.25 and -1.75 diopters, and cyllindrical values of -1.5, -1.5 and -2.0 diopters. After the examiners' retinoscopy and subjective refraction, but before the candidates evaluate the patients, their left eyes are dilated with drops containing 1.0% tropicamide and 2.5% neosynephrine, the same solution that has been used since 1983. The result is left-eyed cycloplegia, paralysis of the intraocular muscle which precludes normal pupillary response of the kind petitioner observed (and reported as +4) in Mr. Roos' right eye, just before performing the refractions. (Patients' left eyes are dilated so candidates can perform other procedures.) As required, petitioner performed his own objective refraction with a retinoscope. He reported an astigmatic orientation of 105o, assigned a spherical value of -0.75 diopters, and put the cylindrical value at -2.25 diopters, for Mr. Roos' (undilated) right eye. After subjective evaluation, he reported a prescription he said effected a correction to 20/20 (a claim no examiner had occasion to evaluate), an axis value of 100o, a spherical value of -1.25 diopters and a cylindrical value of -2.0 diopters. In keeping with the grading protocol applied evenhandedly to all candidates, petitioner's evaluations were compared, item by item, to those of the examiner who most nearly agreed with his conclusions. This yielded discrepancies of 5o, 1.0 and 0.5 diopters for the retinoscopic or objective refraction results; and of 7o, 0.5 and 0.0 diopters for the subjective results. In no case did his results fall between differing examiners' results, although he agreed with one examiner on one result. Petitioner received two points for the objective refraction portion of the test and three points for the subjective portion. Chamber Depth For section two of the clinical portion of the test, Mr. Roos returned to the candidate with whom he came to the examination, and petitioner turned to the eleventh-hour recruit who had accompanied him. Reading the prescribed script, an examiner instructed petitioner in these words: Estimate the depth of the anterior chamber using the Von Herrick-Shaffer technique. Remember that IV is wide open and I is narrow. Respondent's Exhibit No. 2. The anterior chamber is deepest at the center and shallowest near the limbus, where the cornea joins the sclera, and aqueous fluid filters out of the eye. Because the angle at the junction affects the rate of flow, the depth at the chamber periphery is more likely to be of clinical significance than the depth at the center. The Von Herrick-Shaffer technique is a means of measuring chamber depth at the periphery, and not in the middle: a slit lamp casts the cornea's shadow on the chamber floor, and the ratio between the length of the shadow and the width of the cornea is determined. By whatever technique, custom and practice mandate measurement of the depth of the anterior chamber at the edge. When petitioner reported the depth at the center of the chamber, neither examiner (both of whom evaluated independently) awarded any points. Tonometry The Goldmann tonometry portion of the test required candidates to gauge intraocular pressure by placing fluorescein on the white of the patient's eye, then placing a probe and aligning the mires of the tonometer. An examiner read to each candidate these directions beforehand: Add fluorescein to non-dilated eye. Perform applanation tonometry and indicate when you have the proper measurement. You will be given a maximum of 2 minutes to perform this procedure. Respondent's Exhibit No. 2. Because the first examiner gave petitioner full credit, and the second gave him no credit, he received half credit for this part of the examination. At hearing, petitioner testified that he was not ready for the second examiner to grade, and conceded that the mires were no longer in alignment when the second examiner checked. (The second examiner also noted a misplaced light source.) But petitioner, who had the prerogative to "indicate when [he] ha[d] the proper measurement," Respondent's Exhibit No. 2, and did so before the first examiner checked, said nothing to the second examiner (who followed closely on the first) to indicate that he felt the measurement was no longer "proper."
Recommendation It is, accordingly, recommended that respondent deny petitioner's application for licensure on the basis of the September 1990 optometry licensure examination, without prejudice to any subsequent application. RECOMMENDED this 10th day of September, 1991, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of August, 1991. COPIES FURNISHED: Alejandro M. Tirado 606 First Street Neptune Beach, FL 32266 Vytas J. Urba, Esquire 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, FL 32399-0792 Patricia Guilford, Executive Director Board of Optometry 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issues in this case are whether Respondent violated Subsections 458.331(1)(m), 458.331(1)(t), and 458.331(1)(u), Florida Statutes (1997),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to Section 20.43, and Chapters 456 and 458, Florida Statutes (2006). At all times material to this proceeding, Dr. Geller was a licensed physician within the State of Florida, having been issued license number 35800 on December 18, 1979. Dr. Geller is board-certified in Ophthalmology. Patient P.K. first presented to Dr. Geller's office on February 17, 1998, for evaluation for refractive surgery. At the time of her first visit, P.K. was 56 years old. She had been experiencing difficulty tolerating contact lenses due to dry eyes, seasonal allergies, and some night vision problems, and did not want to wear glasses. Prior to P.K.'s first visit to Dr. Geller, P.K. had been evaluated by Dr. Jonathan Frantz to determine if she was a good candidate for laser refractive surgery. Dr. Frantz informed P.K. that she was not a candidate for laser refractive surgery. Dr. Geller examined P.K.'s eyes on February 17, 1998, at which time he recorded P.K.'s visual acuity with corrective lenses for both eyes. He did not record her uncorrected visual acuity. The evidence did not establish that the failure to determine and record P.K.'s uncorrected visual acuity prior to surgery was below the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. During the examination on February 17, 1998, Dr. Geller determined P.K.'s anterior chamber depth to be 2.78 by using an optical device and 2.76 - 2.8 by using a sonogram. Dr. Herbert Gould testified as an expert witness for Dr. Geller. It was Dr. Gould's opinion that at least 2.8 millimeters of depth was needed in the anterior chamber for the insertion of a phakic lens. Dr. Osama Omar testified as an expert for the Department. Dr. Omar was of the opinion that an anterior chamber depth of three millimeters was needed for the insertion of a phakic intraocular lens; however, Dr. Omar's opinion was based on a course that he had taken involving an Artisan lens, not a Phakic 6 intraocular lens, which was used in P.K.'s surgery. Dr. Gould's testimony concerning the anterior chamber depth needed for the insertion of a phakic lens is more credible. Dr. Geller measured P.K.'s preoperative endothelial cell count for both eyes by specular microscopy. The reading was more than 2400. Based on his examination of February 17, 1998, Dr. Geller diagnosed P.K. with hyperopia (farsightedness) in both eyes. Dr. Geller told P.K. that he could implant a phakic intraocular lens in each eye that could correct the refractive errors. When a phakic intraocular lens is used, the patient's natural, crystalline lens is left in place, and the intraocular lens is placed either right in front of the iris or in the pupil area plane right behind the iris. Dr. Geller discussed the risks and benefits associated with the insertion of a phakic intraocular lens with P.K. and made a notation of the discussion on P.K.'s medical records for February 17, 1998. His notes established that he had discussed over and under correction, fluctuating vision, corneal disease, and future surgery with her. P.K. was scheduled for the insertion of a phakic intraocular lens in her left eye on March 10, 1998, and in her right eye on March 31, 1998. P.K. signed a consent form for each surgery scheduled to be performed. The consent forms provided: INFORMED CONSENT FOR LENS IMPLANTATION CORRECTION OF REFRACTIVE ERRORS Dear Patient, The South Florida Eye Clinic and Dr. Scott L. Geller have prepared this "informed consent" so that you may understand some of the major details of 'permanent contact lens' intraocular lens implantation. This informed consent naturally is limited in scope and we will just address some major issues related to all ophthalmic surgery. Your discussion with Dr. Geller can elaborate on any of these issues and can touch on other considerations that you may have. Implants performed for correction of refractive error (to get you minimal eyeglass correction, or no eyeglass correction at all) have been performed since the early 1950's. However, in the last ten years, they have been widely performed throughout the world especially in Europe and South America. Lens implants for correction of refractive errors are performed by individual doctors in the United States under 'the scope of medical practice.' At this juncture no FDA approved lenses are available. The lenses being used in our practice have been obtained by Dr. Geller for use in our ongoing clinical studies for correction of errors of refraction. Lens implants have been performed by our office during and after cataract surgery for the past 15 years and Dr. Geller has extensive experience in all lens implant operations. The lens implant operation for the correction of refractive error is very similar to the operation performed for correction of aphakia that has been done by ophthalmologist [sic] worldwide for well over 20 years. Lens implant for refractive error however have [sic] only been performed widely for about the past eight years. We can only predict based on our experience with this and similar surgeries that the operation is safe and effective. However we cannot predict the future and we want you to understand this. The problems that can be associated with any kind of intraocular surgery include [sic] intraocular lens implantations are hemorrhage, infection, cataract, glaucoma, and the necessity for future corneal surgery. We will remind you that these are potential problems that can occur with any similar surgery, and are rarely seen during the career of any ophthalmologist. There have been reported optical aberrations rarely after lens implantation surgery, notably glare or a refractive error that is not exactly as predicted. This may necessitate a change of the lens or a revision of the wound. These problems are extremely rare. Dr. Geller wants to assure you that he is totally confident that this procedure is the most effective for you at this time. In studying this procedure under a world renowned ophthalmologist and has seen patients who have had several years or internal contact lens use. If you should have any further questions, please don't hesitate to ask Dr. Geller directly. Dr. Geller told P.K. that he had done many lens implants. Dr. Geller's assistant also told P.K. that Dr. Geller had been doing lens implants for a long time with good results. Based on the representations from Dr. Geller and his assistant and the information contained in the consent form, P.K. understandably was left with the impression that Dr. Geller had been doing the implantations of Phakic 6 intraocular lenses in his office on a regular basis and that he had done many of the implantations without problems. On March 10, 1998, when Dr. Geller performed the scheduled lens implantation surgery on P.K.'s left eye, he noted her corrected visual acuity, but did not record her uncorrected visual acuity. During the surgery, Dr. Geller inserted a Phakic 6 intraocular lens manufactured by Ophthalmic Innovations into P.K.'s left eye. On March 31, 1998, P.K. presented at Dr. Geller's office for lens implantation in her right eye. Prior to the surgery, Dr. Geller checked the uncorrected visual acuity of P.K.'s right eye, which was 20/150. During the surgery, Dr. Geller inserted a Phakic 6 intraocular lens manufactured by Ophthalmic Innovations into P.K.'s right eye. In March of 1998, the lenses which were inserted in P.K.'s eyes were not approved by the Food and Drug Administration (FDA). The Phakic 6 intraocular lens had been approved for use in Canada and some countries in Europe, Asia, and South America. At the time of P.K.'s surgery, the phakic lenses were not available through standard, mainstream commercial sources within the United States. Dr. Omar opined that the use of a lens which has not been approved by the FDA falls below the standard of care which should be used by a reasonably prudent similar physician. Dr. Herbert Gould and Dr. James Rowsey, who also testified as expert witness for Dr. Geller, opined that the use of a lens which has not been approved by the FDA, by itself, does not equate to a failure to practice with that level of care, skill, and treatment, which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. The testimony of Drs. Gould and Rowsey are more credible. It should be noted that the FDA did not ban the use of the Phakic 6 lens, but that the lens had not been investigated and approved by the FDA. There have been other products which have not been approved by the FDA, but which physicians use without falling below the standard of care required of the physicians. One such product is glue which was used by physicians in eye surgery. P.K. returned to Dr. Geller's office for postoperative care in March and April 1998. She was in Canada during the summer of 1998 and did not see Dr. Geller from April to October 1998. On October 15, 1998, P.K. presented to Dr. Geller complaining of sensitivity to light and poor visual acuity. Dr. Geller diagnosed P.K. as having iritis. On October 21, 1998, Dr. Geller indicated in P.K.'s medical notes to "get spec micros ou," which indicates a specular microscopy for both eyes. Such a test would indicate P.K.'s endothelial cell count. Dr. Geller's notes indicate a similar entry on November 2, 1998. Dr. Geller's medical notes for P.K.'s visit on November 17, 1998, indicate "spec done ou," but reveal a pachymetry reading of 56/48 and do not indicate an endothelial cell count. Pachymetry is a test which is used to determine the health of a cornea by measuring the thickness of the cornea. The specular microscopy measures the endothelial cell density of the cornea. The testimony of Dr. Omar is credited that a postoperative specular microscopy was required to be done in order to compare the preoperative and postoperative endothelial cell counts. On November 17, 1998, Dr. Geller identified a corneal edema in P.K.'s right eye. He did not refer P.K. to a corneal specialist. Dr. Geller had experience in treating corneal problems, including performing corneal transplants. His experience and training was sufficient to treat P.K.'s corneal edema without having to refer her to a corneal specialist. Dr. Geller treated the edema with anti-inflammatory drugs. The edema continued to be present on subsequent visits on December 1, 3, and 9, 1998. On December 9, 1998, Dr. Geller recommended the removal of the phakic intraocular lens from P.K.'s right eye. He removed the lens on December 15, 1998. Dr. Geller provided postoperative care for P.K. through March 1999. P.K. did not return to see Dr. Geller after March 1999. P.K. returned to Canada and in June 1999 saw Dr. Peter J. Agapitos, who diagnosed her with corneal edema in both eyes and recommended that P.K. return to Florida to have Dr. Geller remove the intraocular lens in the left eye. On June 21, 1999, P.K. called Dr. Geller's office complaining that her left eye was very sensitive to light, crusty, and irritated. Dr. Geller's office referred P.K. to a physician in Canada. P.K. had the intraocular lens in her left eye removed. Additionally, she has required cataract surgery and more than one corneal transplant since Dr. Geller performed the phakic intraocular lens implantations. Dr. Omar was of the opinion that the implantation of a phakic intraocular lens to treat refractive error was experimental in 1998. He defined "experimental" as "a treatment that's currently untested, not developed to the point which can be offered in a mainstream fashion, has not demonstrated safety, ethicacy [sic] in the correction of the problem that the patient may need." Drs. Gould and Rowsey did not feel that the procedure was experimental by 1998. Dr. Rowsey did opine that the procedure was "uncommon" in the United States. Physicians in Europe, Asia, and South America were doing phakic intraocular implants during the 1980's. By 1998, there were peer reviewed literature published concerning phakic intraocular implants and a considerable amount of presentations given concerning the use of phakic intraocular lenses. The production of the Phakic 6 intraocular lens began in 1992, and by the time of P.K.'s surgery, approximately 4,000 to 5,000 implants of the Phakic 6 intraocular lens had been done successfully worldwide. However, few physicians in the United States were performing phakic intraocular lens implantations by 1998, and only a couple of dozen phakic intraocular lens implants had been done in the United States by 1998, representing less than one percent of the total intraocular lens implantations. In 1998, there was no doctor in the United States who was routinely implanting these lenses except as part of a study. In 1997, Dr. Geller went to New York City to the surgery center of Dr. Miles Galin, who was performing implantations of phakic intraocular lenses. Dr. Geller observed several preoperative and postoperative cases on the day he visited Dr. Galin. Dr. Geller also "scrubbed in" and observed at least one implantation being performed by Dr. Galin. Prior to performing surgery on P.K., Dr. Geller had performed less than five implantations of phakic intraocular lenses and had reviewed literature in American and European journals concerning phakic intraocular lenses. The procedures and skills used to insert an intraocular lens implant are substantially similar to those procedures and skills necessary to place an anterior chamber lens after a cataract removal. Dr. Geller's practice involves anterior segment surgery, including cataract surgery. The evidence established that Dr. Geller had adequate education and training to be able to insert phakic intraocular lenses.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Geller violated Subsections 458.331(1)(m), 458.331(1)(t) and 458.331(1)(u), Florida Statutes; imposing a reprimand; imposing an administrative fine of $1,000 for each violation for a total of $3,000; placing Dr. Geller on probation for one year on the terms to be set by the Board of Medicine; and requiring Dr. Geller to attend continuing medical education courses to be specified by the Board of Medicine. DONE AND ENTERED this 2nd day of November, 2006, 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 2nd of November, 2006.
