Findings Of Fact On or about April 14, 1988, the Petitioner, Richard N. Harper, applied with the Respondent, the Department of Insurance, Division of State Fire Marshal, for certification as a fire fighter. On or about April 26, 1988, the Department notified the Petitioner, through his employer, the Polk County Fire District, that additional information was needed on his application--including, among other things, a re-check of his uncorrected vision by an optometrist. On or about September 6, 1988, the Department again notified the Petitioner that additional information was needed on his application--again including, but not limited to a re-check of his uncorrected vision by an optometrist. On or about October 17, 1988, the Department notified the Petitioner that his application was being denied because his uncorrected visual acuity allegedly is not good enough. The Petitioner's uncorrected vision is 20/200 in both eyes; his corrected vision is 20/20 in both eyes. The National Fire Protection Association's pamphlet entitled NFPA NO. 1001, "Fire Fighter Professional Qualifications," 1981 edition Section 2-2, "Medical Requirements for Fire Department Candidates," prescribes medical standards which include the following standards for vision: Vision. The cause for rejection for appointment shall be: * * * (b) STANDARD VISUAL ACUITY. Standard visual acuity without correction, less than 20/40 in one eye, and 20/100 in the other eye; and with correction, less than 20/20 in one eye, and 20/40 in the other eye.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Respondent, the Department of Insurance and Treasurer, Division of State Fire Marshal, enter a final order granting the application of the Petitioner, Richard N. Harper, for certification as a fire fighter. RECOMMENDED this 2nd day of May, 1989, in Tallahassee, Florida. Hearings Hearings LAWRENCE JOHNSON Hearing Officer Division of Administrative The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative this 2nd day of May, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NO. 88-5655 To comply with the requirements of Section 120.59(2), Florida Statutes (1987), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted but unnecessary. 2.-6. To the extent they propose that Harper's uncorrected vision is better than 20/200 in either eye, rejected as subordinate to facts contrary to those found. To the extent they propose that, except for vision, Harper is physically qualified to be a fire fighter, accepted but irrelevant to the issues raised in this proceeding. To the extent that they propose that Harper's vision meets licensure requirements, accepted and incorporated. 7. Accepted but subordinate. 8.-9. Accepted but subordinate and unnecessary. Respondent's Proposed Findings of Fact. 1. Accepted but unnecessary. 2.-6. Accepted and incorporated to the extent necessary. 7. Unnecessary. COPIES FURNISHED: Lawrence C. Stewart, Jr., Esquire Jollay and Stewart, P.A. Post Office Box 979 Winter Haven, Florida 33882-0979 Lisa S. Santucci, Esquire Office of Legal Services 413-B Larson Building Tallahassee, Florida 32399-0300 Honorable Tom Gallagher State Treasurer and Insurance Commissioner Department of Insurance and Treasurer 413-B Larson Building Tallahassee, Florida 32399-0300 Don Dowdell, Esquire General Counsel Department of Insurance and Treasurer Larson Building Tallahassee, Florida 32399-0300 ============================================================ =====
Findings Of Fact Petitioner took the podiatry licensure examination administered by the Respondent in July, 1989, receiving a grade of 70.5%, with 254 correct answers. A score of 75%, with 270 correct answers, is required to pass the examination for licensure. This podiatry examination was developed by the Bureau of Examination Services in conjunction with consultants who served as "item writers", and Florida licensed podiatrists. Five Florida licensed podiatrists selected items written by the various consultants from a bank of questions available for the 1989 examination. Competent substantial evidence was not introduced on behalf of the Petitioner to establish that the examination was in any way flawed in its preparation or method of selecting the actual questions used on this exam. The Petitioner testified that as many as thirty questions in the examination booklet which she received at the exam site had misspellings. The actual question booklets used for the July, 1989, exam were introduced in evidence, but the Petitioner failed to establish, by competent substantial evidence, that there were any significant misspellings in these booklets which would in any way impair the fairness or validity of the examination results. There is a lack of competent substantial evidence in the record to establish that the grades which the Petitioner received on the July, 1989, podiatry licensure examination were incorrect, unfair, or invalid, or that the examination was administered in an arbitrary or capricious manner. The Petitioner totally failed to introduce any evidence which would establish that there were material misspellings in the examination booklets which would impair the validity of the grading results.
Recommendation Based upon the foregoing, it is recommended that Respondent enter a Final Order dismissing the Petitioner's challenge to the grades she received on the July, 1989, podiatry licensure examination. RECOMMENDED this 7th day of May, 1991 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 7th day of May, 1991. APPENDIX TO RECOMMENDED ORDER, CASE NO. 90-2802 Despite waiting an additional seven days until April 25, 1991, as requested by counsel for the Petitioner in his letter filed on April 19, 1991, no proposed recommended order was filed on behalf of the Petitioner. Rulings on the Respondent's Proposed Findings of Fact: Adopted in Finding 1. Adopted in Findings 2 and 3. Adopted in Finding 3. COPIES FURNISHED: Melvyn G. Greenspahn, Esquire 3550 Biscayne Boulevard Suite 404 Miami, FL 33137 Vytas J. Urba, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Jack McRay, Esquire Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Patricia Guilford Executive Director Board of Podiatry 1940 North Monroe Street Tallahassee, FL 32399-0792
Findings Of Fact Introduction The Respondent, Jon F. Stoneburner, O.D., is a licensed optometrist in the State of Florida, and has been so licensed since January, 1977. On November 7, 1985, Alison Lichtenstein and Mary Pfab, O.D., went to the office of the Respondent, Jon F. Stoneburner, O.D., for eye examinations. Both used fictitious names. Ms. Lichtenstein presented herself as Alison Smith, and Dr. Pfab presented herself as Mary Parker. During the visual analysis by Dr. Stoneburner of Ms. Lichtenstein, Dr. Pfab was seated six to eight feet away. T2. 43. Dr. Stoneburner's back was facing Dr. Pfab, and she was viewing the examination of Ms. Lichtenstein from an angle. T2. 41. On the diagram drawn by Dr. Pfab, Dr. Pfab was seated in the position marked either 1 or 2, Dr. Stoneburner was located at the position marked St., and Ms. Lichtenstein was seated in the chair which is marked C. R. Ex. 3; T2. 40. Located in the room was a stand, a Phoropter, a biomicroscope, a keratometer, a retinoscope, and a tangent screen. T2. 40, 42. It is normal for such equipment to be placed on either the right or left side of the examination chair. T2. 43. It is concluded that some of this equipment was to one side or the other of the examination chair in which Ms. Lichtenstein was seated, but the actual positioning of the equipment is not in evidence in this record. T2. 41- Although the equipment may have been to the left or right of the examination chair, from the diagram it is evident that placement of the equipment to either the left or right side would not have obstructed Dr. Pfab's vision of Dr. Stoneburner and Ms. Lichtenstein since Dr. Pfab was seated on an angle behind Dr. Stoneburner. R. Ex. 3. From the diagram drawn and Dr. Pfab's testimony, it is concluded that Dr. Pfab was unable to clearly see Dr. Stoneburner's examination of Ms. Lichtenstein with respect to placement of Dr. Stoneburner's hands very close to Ms. Lichtenstein's face, i.e., one or two inches away from Ms. Lichtenstein's face, since Dr. Pfab's vision of such movements would have been partially blocked by Dr. Stoneburner's body. Other than that blind spot, Dr. Pfab could clearly see Dr. Stoneburner's movements during the examination, and could hear everything he said. T2. 43-44. Dr. Pfab received a degree in optometry in 1985. T. 10. At the time of the examination by Dr. Stoneburner, Dr. Pfab had had an externship in Jacksonville, Florida, and Fort Lee, Virginia, and was a licensed optometrist in Tennessee. T. 10-11. During her externships, she was required to perform eye examinations that conformed to the requirements of rule 21Q- 3.007, Fla. Admin. Code. T. 11. Dr. Pfab was licensed as an optometrist in Virginia and North Carolina in 1986, and in Florida in 1987. T. 11. Dr. Pfab was tendered as and accepted as an expert witness in the practice of optometry in Florida. T. 12, 16-18. In the first day of the formal hearing, the Hearing Officer sustained an objection to the testimony of Dr. Pfab to the extent that it involved her work for the Petitioner as an investigator. Following the close of the hearing, the Hearing Officer on his own motion determined that this ruling was in error, and reopened the record to allow Dr. Pfab to testify as to the results of her investigation on behalf of the Petitioner. That portion of the reopened hearing was conducted on August 31, 1988. Ms. Lichtenstein was not accepted as an expert with respect to the minimum examination procedures in the practice of optometry in Florida. T. 47, 50-51. She was allowed, however, to testify as a lay witness to what she perceived in the course of her investigation conducted on behalf of the Petitioner. Following the November 7, 1985, visit of Dr. Pfab and Ms. Lichtenstein, Ms. Judith Leff interviewed the Respondent and obtained copies of the records of the examinations of Dr. Pfab and Ms. Lichtenstein. T. 65. Ms. Leff asked Dr. Stoneburner to show her in the records of each patient where each of the minimum procedures listed in the rule had been recorded as having been performed, and Dr. Stoneburner showed Ms. Leff in both records where there was an entry that each procedure had been performed. T. 74. The patient records that are at issue in this case, P. Exs. 5 and 6, were not signed by Dr. Stoneburner in his capacity as a licensed practitioner of optometry, and Dr. Stoneburner's signature on these patient records was not required by law. It is normal practice in optometry for an optometrist to improvise and devise his or her own techniques for performing the minimum examination procedures. T. 92, 95. The visual fields or confrontation fields test A visual fields test tests the retina and the nerve pathways to the brain. T. 84. A visual fields test is a check for a brain tumor, and particularly a pituitary tumor. T2 -22. A visual fields test is required as a part of a minimum eye examination by an optometrist in the State of Florida. A minimum visual fields test is a confrontation fields test. T. 28, 80. In the confrontation fields test, the patient covers one eye with an opaque object, commonly a paddle. The patient is then asked to focus the other eye upon an object held by the examiner. The patient is required to tell the examiner when he or she can see the object moving into his or her peripheral vision. The examiner then moves a second object from beyond the peripheral vision of the patient from both horizontal sides (left and right) and from both vertical sides (up and down). The examiner observes that the patient continues to focus upon the target object. A confrontation fields test necessarily involves communication from the patient to the optometrist. T. 20-21,80-81, 124, 164, 185. The movements necessary to conduct a confrontation fields test (movement of paddles, movement of objects to the right and left sides of and above and below the patient's head) would have been visible to Dr. Pfab seated behind Dr. Stoneburner, and would not have been blocked by his body or equipment. Dr. Pfab, of course, could easily have observed these movements during her own examination. Dr. Pfab could have heard Dr. Stoneburner communicating with Ms. Lichtenstein during the confrontation fields test had he done so, and certainly would have observed Dr. Stoneburner communicating with her during her own examination. Neither Dr. Pfab nor Ms. Lichtenstein had any handicap or other impediment that would make normal voice communication not feasible between either of the two patients and Dr. Stoneburner. T. 189. Other forms of visual fields tests are more complicated and involved than a confrontations fields test. There is no evidence in this record that Dr. Stoneburner used any other more complicated test. Dr. Stoneburner could not remember whether he did a confrontation fields test on Ms. Lichtenstein by moving objects in and out of her peripheral vision and communicating with her concerning what she saw. T. 180. He did not testify that he performed any other specific form of confrontation fields test on Ms. Lichtenstein. He asserted, however, based upon his written record that some form of visual fields testing was done. T. 181. At no point during the examination did Dr. Stoneburner ask Ms. Lichtenstein if she could see his fingers or any other object moving or to look straight ahead at any object. T. 56-57. At no point during the examination did Dr. Stoneburner stand in front of Ms. Lichtenstein and bring an object into and out of view or ask her to line up objects horizontally and vertically. T. 59. Ms. Lichtenstein moved her eyes, as one normally does, as she entered the room and while she was in the examination room. T. 62. Observation of a patient as he or she walks and avoids obstacles gives the optometrist some indication as to the visual field of the patient. It is not an adequate confrontation fields test. The expert who testified as to this issue was asked on two occasions whether mere observation of a patient walking would constitute an adequate visual fields test, and he failed to answer except to imply that such observation would be a partial visual fields test. R. Ex. 2, pp. 15-17. It is concluded that observation of a patient as he or she walks and avoids obstacles is not an adequate visual fields test. Ms. Lichtenstein could have observed Dr. Stoneburner moving equipment within the room, but Dr. Stoneburner did not ask her the extent to which she saw the equipment move. T. 64. Without such communication, the movement of equipment is not an adequate visual fields test because Dr. Stoneburner would have had no way to know the extent to which Ms. Lichtenstein saw such movement. Dr. Stoneburner did not perform a visual fields or confrontation fields test on Ms. Lichtenstein. T2. 19. Dr. Stoneburner called out to his secretary for recording the results of a confrontation fields test for Ms. Lichtenstein, however, and Ms. Lichtenstein's patient record has an entry indicating that a confrontation fields test was done. T2. 19; P. Ex. 5. Dr. Stoneburner called out to his secretary for recording the results of a confrontation fields test for Dr. Pfab, and Dr. Pfab's patient record has an entry that indicates that a confrontation fields test was done, but Dr. Stoneburner did not perform a confrontation fields test on Dr. Pfab. T2. 25-26; P. Ex. 6. The pupillary examination A pupillary examination is required as a part of a minimum eye examination by an optometrist in the State of Florida. T2. 27. A pupillary examination is useful to detect brain tumors, diabetic conditions, retinal detachment, temple arteritis, optic neuritis, and other diseases. T. 82; T2. 21-22. There are three parts to a pupillary examination: direct, consensual, and accommodative. T. 79. In the direct pupillary examination, the doctor observes if the pupils are the same size and shape. T. 25. The eye is then approached from about 12 inches away with a light such as a penlight, and if the pupil constricts, a normal response is recorded. In the consensual pupillary examination, the light from 12 inches is moved to the opposite eye, and the response of the first eye is observed. T. 79, 26, 34, 123. Additionally, the light is swung back and forth from eye to eye from about 12 inches to check for Marcus Gunn pupil defect. T. 26, 34. The accommodative pupillary examination is performed by having the patient focus in the distance; the patient then is asked to look at a close object, with the eyes crossed, and the reflex of the pupils is observed. T. 80. A pupillary examination is performed in dim illumination. T. 25; T2. 21, 44-46. The actions of a doctor performing a pupillary examination are very obvious to an observer familiar with the nature of such an examination. The exam is not difficult to see as it occurs. T2. 36. The movements of hands and oral communication necessary to conduct a pupillary examination on Ms. Lichtenstein (movement of a light back and forth from a distance of 12 inches and communicating with the patient to ask the patient to focus in the distance and then to focus at a close object) involve activities that Dr. Pfab could have clearly perceived from where she was seated behind Dr. Stoneburner. Dr. Pfab clearly could have observed and heard these same actions during her own examination. It is irrelevant that she could not observe the results of the examination. T2. 44. Dr. Stoneburner stated to investigator Leff that he normally performed the external examination and the pupillary examination during the biomicroscopy (slit lamp) examination, and that he normally also performed the external examination during the ophthalmoscope examination. T. 68. In direct testimony, however, Dr. Stoneburner testified that he normally does the external examination and the pupillary examination with his penlight. T. 169. He also stated that he did these examinations right after (or during) the visual acuities test. T. 169. He testified that he generally does the visual acuities test, but he assumed that his staff did it on Ms. Lichtenstein and Dr. Pfab, though he was unclear on the point. T. 168, 183. There is no evidence that Dr. Stoneburner used a pen light to examine either Ms. Lichtenstein or Dr. Pfab. Later in his testimony, Dr. Stoneburner testified that he did the pupillary examination in three ways. The first was by "sweeping of the pencil while they're watching the chart . . . ." T. 173-74. The second was during the slit lamp observation. T. 174. And the third was with the ophthalmoscope. T. 174. During the examination of Ms. Lichtenstein, Dr. Stoneburner did not shine the light of the opthalmoscope into either of her eyes from a distance greater than one inch. T. 52- 53. Dr. Stoneburner did not stand in front of her and shine a light into either of her eyes. T. 59. Dr. Stoneburner testified that he felt he could do a direct pupillary examination with a slit lamp, but admitted that a consensual pupillary examination is often not done with a slit lamp. T. 175. Since the slit lamp is so large and heavy, it is unsuitable to use for a consensual pupillary examination because it is so difficult to move the slit lamp back and forth. T2. 31-32. Moreover, the slit lamp fits directly against the face, and has a chin rest, making such gross movements improbable. T. 143. In the examination of Ms. Lichtenstein and of Dr. Pfab, Dr. Stoneburner did not swing the biomicroscope (slit lamp) from eye to eye. T. 60; T2. 64. Dr. Stoneburner did not conduct a pupillary examination upon either Ms. Lichtenstein or Dr. Pfab, T. 59-60, T2. 17, 20-21, 27, 30, but the notation "normal" for the direct and consensual pupillary test ("pupils D & C") was entered on the charts of both Ms. Lichtenstein and Dr. Pfab. P. Exs. 5 and 6; T2. 30. The extra ocular muscle balance test An extra ocular muscle balance test is one of the minimum procedures that must be performed by an optometrist during vision testing in the State of Florida. T2. 16-17, 23. The purpose of the extra ocular muscle balance test is to check for the existence of binocular vision (use of both eyes) and the neurological integrity of the eye muscles. T2. 64. From notations in Ms. Lichtenstein's record, Dr. Stoneburner believed that the extra ocular muscle balance test was performed on Ms. Lichtenstein. T. 181-82. Relying upon notations on the chart, since he had no memory on the subject, he concluded that a stereo fly test and depth perception fusion tests had been performed on her, and that these tests assessed extra ocular muscle balance. Id. He noted in particular that "No. 8," which is the place on the chart for recording phorias, was "ortho" or normal. Ms. Lichtenstein's record shows the notation "0" for phorias No. 8. P. Ex. 5. He also noted that there was a negative (abbreviated "ng") notation on her record for the cover test. Observation of a person moving his or her eyes around the room from across the room is not an acceptable method in the practice of optometry to perform an extra ocular muscle balance test. T2. 78. One form of extra ocular muscle balance test is a cover test. The test is performed with the patient focusing upon a distant object and a near object. In both cases, the optometrist covers and uncovers the one eye several times, watching the movement of the eye that is not being covered. Then the other eye is tested in the same way. Finally, the object used to cover the eye is moved back and forth to cover one eye and then the other, and the movement of the uncovered eye as it is uncovered is observed. Thus, the cover test has four parts. T2. 20; T. 126. Only one fourth of a cover test can be performed during a visual acuity test. T. 31, 34-35. Thus, an extra ocular muscle balance test cannot be done by an acuity test. T2. 37. A stereo acuity test is not an acceptable method in the practice of optometry to perform an extra ocular muscle balance test. T2. 64, 38. Phorias is a form of extra ocular muscle balance test. T2. 30. Phorias are a measurement of the alignment of the eyes. T2. 29. The patient's eyes are disassociated with prisms, and the patient is asked to align the image from each eye vertically and horizontally. Id. Although there is a notation in her record (the symbol O) that phorias were performed on Dr. Pfab, Dr. Stoneburner did not perform that procedure upon her. P. Ex. 6; T2. 29. Dr. Pfab certainly would have observed if Dr. Stoneburner had disassociated her eyes with prisms. The movements necessary to perform a cover test (covering and uncovering an eye) would have been clearly seen by Dr. Pfab from where she was sitting behind Dr. Stoneburner. Dr. Stoneburner did not perform a cover test or extra ocular muscle balance testing on Dr. Pfab, but he called out tests results for a cover test, and those results were recorded on Dr. Pfab's chart by the notation "ng." T2. 25, 27, 29; P. Ex. 6. Dr. Stoneburner did not perform an extra ocular muscle balance test or a cover test upon Ms. Lichtenstein, but he did call out results of a cover test for recording on Ms. Lichtenstein's chart, and those results were recorded on Ms. Lichtenstein's chart by the notation "ng." T2. 20, 23; P. Ex. 5. The tonometry test A tonometry test is required as a part of a minimum eye examination by an optometrist in the State of Florida. T2. 27. Dr. Stoneburner had an air-puff tonometer in his office, but not in the room he used to examine Ms. Lichtenstein and Dr. Pfab. T2. 27, 42. Dr. Stoneburner has delegated the tonometry examination to a non- optometrist member of his staff. T. 133. Dr. Pfab wore hard contact lenses during her visit to Dr. Stoneburner. P. Ex. 6. Dr. Stoneburner determined to not perform tonometry testing on Dr. Pfab because he determined that he needed her records to be able to do a proper test because she wore hard contact lenses. T2. 83. Dr. Stoneburner noted in Dr. Pfab's patient record that he would perform tonometry on her next visit. P. Ex. 6. Dr. Pfab was not told that she needed to return for tonometry testing. T2. 28. Prior disciplinary action By order dated January 30, 1984, Dr. Stoneburner paid $500.00 in costs to settle disciplinary case number 31308, but neither admitted nor denied the charges brought against him. The case ended by settlement, and Dr. Stoneburner was not represented by a lawyer. The charge is accurately represented in P. Ex. 9 and concerned the allegation of practice under a trade name. "The Eye Center," and thus the allegation of engaging in the practice of optometry with unlicensed persons.
Recommendation For these reasons, it is recommended that the Department of Professional Regulation, Board of Optometry, enter its final order finding that Jon F. Stoneburner, O.D., committed the violations alleged in counts one, two, and three, of the administrative complaint, and imposing an administrative fine of $4,000 and probation, upon such conditions as the Board may direct, for 12 months. DONE and ENTERED this 24th of October, 1988, in Tallahassee, Florida. WILLIAM C. SHERRILL, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of October, 1988. APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-4103 The following are rulings upon proposed findings of fact which have either been rejected or which have been adopted by reference. The numbers used are the numbers used by the parties. Statements of fact in this appendix are hereby adopted as additional findings of fact in this recommended order. Findings of fact proposed by the Petitioner: None. Findings of fact proposed by the Respondent: 1-2. These proposed findings of fact are not supported by the record. Dr. Pfab was not tendered as an expert consultant or investigator, but as an expert in the practice of optometry. T. 12, 16. The Hearing Officer's initial ruling to exclude Dr. Pfab's testimony was limited to her role as an investigator, not as an expert as tendered; Dr. Pfab was at all times in this case accepted as an expert as tendered. T. 17-18. The Hearing Officer subsequently determined that this initial ruling, a ruling that precluded testimony, but was not based upon lack of expertise, was in error since the employment rule of the Petitioner was not intended to preclude testimony in a hearing. Rejected as explained in findings of fact 3-5, 17-18, 33, and 54. It appears from the record that in the March 16, 1986, statement, Dr. Pfab stated that a pupillary test was not obviously done, and visual testing was not done. T. 32-33. Since some "visual testing" was in fact done, it is inferred by the wording of the question that "visual testing" here means visual fields testing. The records clearly indicate that tonometry was not performed on Dr. Pfab. Thus, the only relevant question is whether Dr. Pfab omitted the extra ocular muscle balance test in her March 16, 1986, statement, and if she did, whether her credibility was impaired. The text of Dr. Pfab's sworn statement dated March 16, 1986, was not placed in evidence. Thus, the context of her statement is unknown. Absent some further evidence as to the context and circumstances surrounding the making of the March 16, 1986, statement, a finding of a lack of credibility of Dr. Pfab cannot be made based upon the foregoing, particularly in light of her credible demeanor during cross examination. The text of Dr. Pfab's sworn statement dated March 16, 1986, was not placed in evidence. There is no other evidence in the record as to Dr. Pfab's characterization of the lack of performance of the pupillary examination on either herself or upon Ms. Lichtenstein in the March 16, 1986, statement in this record. Thus, a finding of "great discrepancy" between that statement and testimony with respect to the pupillary exam is not supported by the record evidence. There was some cross examination concerning Dr. Pfab's statement in her November 8, 1985, report (also which is not in evidence) that the pupillary exam was "not obviously done," but that had nothing to do with the March 16, 1986, statement. Moreover, Dr. Pfab credibly explained that a pupillary exam, when performed, would be obvious. T2. 36. This proposed finding of fact is not supported by the evidence of record. The proposed finding of fact fails to identify the nature of the "major differences," or to cite to the record. The observations of Ms. Lichtenstein were observations to which any competent lay witness could testify, and added credence to the testimony of Dr. Pfab. This proposed finding of fact is irrelevant since Ms. Leff was simply presented with Dr. Stoneburner's false records. Her conclusion is limited to her conversations with Dr. Stoneburner on April 9, 1986. R. Ex. 1; T 65-74. 14, 16-19, 21, 22, 25, 26. These proposed findings of fact are subordinate to findings of fact that have been adopted. They are true, however, and are adopted by reference. 20. Dr. Kantor's testimony was too vague to constitute a contradiction of Dr. Pfab's testimony. Dr. Kantor only described bits and pieces of the minimum tests that might be used. He never explicitly described or defined an adequate test. For example, he acknowledged that a pupillary examination might involve consensual light reflex and direct light reflex, R. Ex. 2, p. 7, but failed to explain how consensual light reflex might be tested with a slit lamp. Dr. Pfab, on the other hand, testified that swinging the slit lamp back and forth would be very awkward, very obvious, and was not done by Dr. Stoneburner. 23. Dr. Shewmaker's description of the pupillary examination, and the movement needed if the biomicroscope was used, was essentially the same as Dr. Pfab's. T. 117, 122, 123. Dr. Shewmaker's description of the movements needed to perform the procedure and need for communication in the visual fields test was essentially the same as Dr. Pfab's. T. 117, 124. Dr, Shewmaker's description of the cover test was essentially the same as Dr. Pfab's. T. 125. To the extent that Dr. Shewmaker testified that a cover test can be done during a visual acuity test, that opinion, having not been explained, is rejected in favor of Dr. Pfab's explanation to the contrary. T. 24-25, 34- 35. Thus, Dr. Shewmaker is not found to be a "more credible witness" than Dr. Pfab. A comparison to Ms. Lichtenstein is irrelevant. Ms. Johnson's description of the pupillary examination was incomplete, and thus it cannot be concluded from her testimony that she observed a minimally adequate pupillary examination. T. 140. Ms. Johnson could not testify that a visual fields test was in fact performed. T. 140-41. Ms. Johnson testified that Dr. Stoneburner performed the extra ocular muscle balance test upon Ms. Lichtenstein using the Phoropter, T. 142, but there is no credible evidence in the record to sustain a finding that an adequate extra ocular muscle balance test can be performed with a Phoropter. Ms. Johnson was not qualified as an expert to express an opinion as to what the minimum requirements are. This proposed finding of fact is true, since that is Dr. Stonburner's testimony, but further findings of fact have not been made from the testimony due to clear and convincing evidence to the contrary. The records from which this proposed finding of fact must be made were not identified by competent evidence as including a record of examination by another doctor; the only indication come from the assertions of counsel, and there is no stipulation of fact in the record precisely explaining the nature of the records. R. Ex. 2, p. 12, lines 6-7, p. 18, lines 5-7. Moreover, the testimony indicates that the witness performing the record comparison was too unfamiliar with the forms to develop a credible opinion. R. Ex. 2, pp. 12-15, 18-20, especially p. 12, lines 23-24 and p. 20, lines 13-17. This proposed finding of fact is actually a conclusion of law, and has been rejected for the reasons stated throughout this recommended order. The second half of this sentence is rejected as contrary to the clear and convincing evidence of record. 32, 33 and 35. These proposed findings of fact have been rejected as contrary to the clear and convincing evidence of record. 34. The Respondent did not keep a written record of the failure to perform the three minimum tests upon Ms. Lichtenstein and Dr. Pfab. COPIES FURNISHED: Thomas W. Stahl, Esquire Phillip Miller, Esquire Newell & Stahl, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313 Robert J. Elkins, Esquire 46 North Washington Street, Suite 12 Sarasota, Florida 33577 Mildred Gardner, Executive Director Board of Optometry Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Bruce Lamb, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 ================================================================= AGENCY ORDER REJECTING MOTION FOR REHEARING ================================================================= STATE OF FLORIDA DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF OPTOMETRY DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF OPTOMETRY, Petitioner, vs. CASE NO. 86-4103 JON F. STONEBURNER, O.D., Respondent. /
The Issue Whether respondent was in violation of Section 43.201 (6), Florida Statutes, and Rule 10D-41.33(2), Florida Administrative Code, by failing to observe certain quality control procedures and by failing to document actions taken as alleged in the Administrative Complaint.
Findings Of Fact STANDARDS APPLIED: In 1967, the Medicare program was established by the federal government. It provided for reimbursement to independent clinical laboratories for services furnished to Medicare patients. Standards for the clinical laboratories were set forth in Subpart M of the Social Security Administration's Regulations No. 5 (Code of Federal Regulations, Title 20, Chapter 3, Part 405), entitled Conditions for Coverage of Services of Independent Laboratories (henceforth Subpart M). Subpart M was administered by the Health Care Financing Administration (HCFA). Also in 1967, the Clinical Laboratories Improvement Act of 1967 (CLIA) was passed by the federal government which applied to laboratories engaged in interstate commerce, and a new Part 74 was added to the Public Health Services Regulations, Title 42, Code of Federal Regulations, which set forth the standards for these laboratories. In 1967, the Florida legislature completely revised the clinical laboratory law that had been in effect in Florida since 1949 by enacting the Florida Clinical Laboratory Law. Ms. Phillips testified that the purpose of the legislation was to parallel the federal requirements for clinical laboratories so that the same standards would apply to all laboratories in Florida. Thus Florida has applied federal standards in its state inspections since 1967. Rule 10D-41.33, Florida Administrative Code, 1/ contains language patterned after the language set forth in Subpart M in 1967. 2/ Thus, although the rule does not incorporate the federal standards by reference, HRS contends that clinical laboratories would be aware that federal standards would apply to state inspections due to the language used in the Rule. 3/ However, clinical laboratories in Florida were never specifically notified that federal standards would apply to state inspections and they were never sent federal regulations, standards or guidelines. TMRMC has been accredited by the Joint Commission on Accreditation of Hospitals (JCAH) since 1979. In 1978, the JCAH adopted the federal quality control standards. Therefore, JCAH accredited hospitals are not subject to federal inspection because, if they meet JCAH standards, they met federal standards. However, the JCAH inspects only once every three years. HRS INSPECTIONS: HRS has a contract with the federal government to perform the inspections of clinical laboratories that are required under federal law. HRS also performs the inspections required by state law. HRS applies the same standards regardless of whether it is a state or federal inspection. Since 1983, state inspections of clinical laboratories have been required annually. However, due to a lack of personnel, annual inspections of every laboratory have not been possible. When an inspection is done, the HRS surveyor has a checklist form to provide a guideline for the inspection. The checklist form follows the requirements in the rules and policies put out by the federal government. After the inspection is concluded, the hospital is not provided with a copy of the checklist but is given a list of deficiencies which are taken from the checklist. The inspector also informs the laboratory director of the deficiencies verbally at an exit conference. The hospital or laboratory gets the statement of deficiencies from HRS on a standard form which lists the deficiencies on the left side and provides space for the laboratory to indicate a plan for correction on the right side. The hospital fills in the right side of the form and returns it to HRS. If the laboratory does not receive a reply back from HRS, the response from the laboratory is acceptable to HRS. HRS INSPECTIONS OF TMRMC: The TMRMC laboratory has been inspected three times by HRS: in 1980, in 1982, and in 1985. The inspection involved in this case occurred from April 16th through April 19th of 1985. The inspection that occurred in 1982 resulted in cited deficiencies. The lab responded to those deficiencies in accordance with HRS procedure. TMRMC did not receive a reply back from HRS on most of the responses and, therefore, considered that those responses provided for adequate quality control. HRS does not customarily impose a fine for a violation unless it is a repeat violation. SPECIFIC CHARGES a. RIA BACKGROUND RECORD DID NOT CONTAIN ACCEPTABLE LIMITS: The RIA background records are associated with an instrument called a gamma counter. The gamma counter counts radioactivity. To insure accurate readings, the level of background radiation must be determined and must be within acceptable limits. Each day prior to running any tests, TMRMC personnel determined the background level, recorded it, and adjusted the machine to subtract the background level so that it would not affect the test results. However, as the background level gets higher, the possibility for error becomes greater. A background level that is too high might affect the test results. Therefore, an acceptable background limit is established. TMRMC established 35 as an acceptable limit. The limit was recorded in the procedures manual for the machine. Since the background limit was stated in the manual, the laboratory technologists did not write it down each time they recorded the background level. Laboratory personnel were to read the procedures manual prior to doing the test and thus would be aware of the limit. Further, the technologists who ran the tests were highly skilled personnel and, after performing the procedure several times, were aware of the limit since it does not change. The background level recorded was outside the limit nine days in March and about 14 days in April of 1985. However, there was no evidence presented as to how far over limit the levels were. TMRMC has a very stringent background limit. A limit of up to 100 would be acceptable. Therefore, at TMRMC, if the background level is slightly over limit, where the test results would not be affected, the machine might simply be adjusted to the background level. However, if the background level is well over limit, the machine would be cleaned. In 1982, TMRMC was notified of a deficiency in their records with the statement "RIA background counts records did not contain acceptable limits." (P. Ex. #7, p.3). TMRMC interpreted this as meaning that the background limit had to be recorded in the manual. The failure to write down the background limit each time the background level is recorded is not inadequate quality control since the background limit is recorded in the procedures manual. Although the labs inspected by Mrs. Bass have always included the background limit on their records, the repetition of the limit each time the level is recorded is simply unnecessary for adequate quality control, and there was no evidence presented that any state, federal, or other authority required that it be done to insure adequate quality control. b FAILURE TO PROVIDE DOCUMENTATION TO SHOW THAT OSMOMETER WAS CALIBRATED EACH DAY OF USE. An osmometer measures osmolality, the concentration of particles in a solution. TMRMC calibrated the instrument to three standards each time the instrument was run. The osmometer displays from 0 to 1,000 millivolts. A standard is placed in the instrument, and the instrument is set so that the volt reading correlates to the standard. TMRMC uses 100, 290, and 1,000 standards. Each standard is placed in the machine, the machine is calibrated to that standard, and an electronic curve is created. After all three standards are set, the technician puts a checkmark on the sheet to indicate the procedure has been followed. Each standard has its number on the bottle. Therefore, it is unnecessary to write down that the 100 standard was set at 100, the 290 set at 290, and the 1,000 set at 1,000. The checkmark indicates that all three standards have been properly set. After the standards are set, controls are run to insure that the calibration is correct. Mrs. Bass, who performed that inspection, felt that the three numbers had to be written down each time the machine was calibrated. However, TMRMC uses the same three standards to calibrate the osmometer each time, the written procedure for the machine requires that all three standards be used to calibrate the instrument, and a checkmark provides the same quality control as writing down 100, 290 and 1,000. Therefore, the checkmark is sufficient documentation to show that the osmometer was calibrated each day of use. HRS rules do not require that the standard number be written down each time to provide documentation, nor do the regulations of Medicare, the CLIA, or the College of American Pathologists. The only requirements are that the machine be calibrated and that the performance of the calibration be documented. FAILURE TO INCLUDE CONTROLS WITH EACH RUN OF TOXI LAB DETERMINATION Toxi-lab is a screening procedure for abusive drugs, such as marijuana and cocaine. A control should be included with each run. TMRMC did include a control with each run, but did not run a control each time in the extraction process. 4/ A control is a sample that contains the analyte which is being checked. It is run through the process at the same time that the specimen is tested. If the control reads the way it is supposed to read at the end of the process, it is presumed that the specimen has been properly processed. There is nothing in the HRS rules that requires a control to be run with each test. However, the federal regulations specify that a standard and a control are to be run with each clinical chemistry test when such are available. Further, adequate quality control would generally require a control to be run. However, with the newer more automated instruments and procedures, running a control with each test is not necessarily required. The toxi-lab test is a fairly new test which became commercially available in 1980 or 1981. There are two types of controls that are used with the test. When HRS inspected in 1982, it stated that a control needed to be run in the extraction process. However, there was no control available for the extraction process at that time. Subsequent to that inspection, a control for the extraction process was found. The company that produced the control recommended that it be run at least once a week, and TMRMC followed the manufacturer's recommendation. Running a control through the extraction process could indicate whether a tube was defective or whether the technologist's technique was correct. However, due to the nature of the test, the fact that the technologist's technique on the control is adequate does not indicate that the patient's specimens are handled properly, and the same applies to the incident of defective tubes. In other words, running a control along with the specimens cannot insure that the tubes with the specimens are not defective or that the technologist's technique on the specimens is the same as on the control. 5/ There was no evidence presented to show that the failure to run a control through the extraction process each time resulted in inadequate quality control. In 1982, HRS stated only that TMRMC had to run a control through the extraction process: it did not specify that the control had to be run each time. Therefore, TMRMC followed the manufacturer's recommendation for the frequency in which to run a control through the process. THREE LEVELS OF CONTROLS WERE NOT RUN ON THE FIRST SHIFT AND A MINIMUM OF TWO (2) LEVELS OF CONTROLS WERE NOT RUN ON EACH EIGHT-HOUR SHIFT THEREAFTER IN THE BLOOD GAS LABORATORY On the blood-gas analyzers, there are three basic levels of controls-a low, a medium, and a high-which are used to check the calibration of the instrument. TMRMC did not have any shift in which all three levels were run. Mrs. Bass stated that HRS requires three levels to be run on one shift, and two levels to be run on the other two shifts, in order for a lab to provide adequate quality control. There is a dispute among the authorities on what is necessary to provide adequate quality control. Some authorities suggest that three levels must be run on each of the three shifts; other authorities believe that two, two, and two is sufficient. In 1982, TMRMC was advised that they had to run the tests on a three, two and two basis. However, subsequent to 1982, TMRMC acquired a newer instrument that was more sophisticated. Thereafter, TMRMC ran one level on each shift, except on days when open-heart surgery was scheduled. On these days, two levels were run on the first shift. The new instrument acquired by TMRMC performs self- checks with sufficient frequency to detect problems in the instruments. The earlier instruments were completely manual and had no self-checks built into them. Therefore, a greater number of controls had to be run to provide adequate quality controls on the earlier machines. Further, the laboratory has two of these highly sophisticated instruments, and whenever a value for a patient deviates from the norm, the specimen is checked on the other machine. Although TMRMC contends that it was running at least one level on each shift, and two levels on the first shift when there was open heart surgery scheduled, TMRMC failed to provide any documentation that they were consistently running a control on the 11:00 at night to 7:00 on the morning shift. Obviously, despite the degree of sophistication of the instruments used by TMRMC even TMRMC felt that adequate quality control required that a control level be run in each shift. However, it is impossible to determine whether the control was run each shift because there was no documentation that it was done. Therefore, TMRMC failed to provide adequate quality control by failing to provide documentation that any control was run daily on the third shift. FAILURE TO CONSISTENTLY DOCUMENT CORRECTIVE ACTION WHEN CONTROL RESULTS WERE OUT OF LIMITS IN THE CHEMISTRY LAB: In February, March and April of 1985, control results in the chemical laboratory were out of limits on 21 occasions. During this time, there was no documentation of any action taken to correct this situation. There was no way of knowing what corrective action was taken before patient results were reported. Since there was no documentation as to what corrective action was taken when the laboratory records showed that the results were not within the stated acceptable limits, there was no way of knowing whether corrective action was actually taken. In many cases a control specimen may be out of limits and still be acceptable. Approximately five percent of the control results will be outside the limits that are set. Corrective action is not always indicated merely because the control is outside of the acceptable limits. It must be judged in the context of the entire day's work to determine whether there is something actually wrong or whether it is just a statistical fluke. Nevertheless, in the 21 instances cited, TMRMC failed to indicated that corrective action was not necessary under the circumstances. Because no documentation was provided, it is impossible to determine whether the out of limits results were acceptable, so that corrective action did not need to be taken, or whether the out of limits results indicated that corrective action needed to be taken and no corrective action was performed. Therefore, by failing to provide the appropriate documentation, TMRMC failed to provide adequate quality control. TAPES FROM THE QUANTUM DRIFT TEST WERE NOT RETAINED FOR TWO (2) YEARS: TMRMC was unable to locate the tapes from the Quantum drift test for the previous two years. During her investigation, Mrs. Bass asked the supervisor to produce the tapes containing the results of the Quantum drift test, which is used as part of RIA analysis, but the supervisor was unable to produce the requested documentation. TMRMC stated that the tapes for the Quantum drift test were retained for two years. The majority of them were discovered after the inspection. The tapes had been relocated from one room to another. Nevertheless, at the time of the inspection, TMRMC did not have the tapes and didn't know where they were. THE CONSTANT PACKING OF THE MICROHEMATOCRIT CENTRIFUGE, IN THE HEMOTOLOGY LAB, WAS NOT CHECKED QUARTERLY: To determine optimum packing of the centrifuge, twelve viales are paired, and one pair is run one minute, one pair is run two minutes, one pair is run three minutes, one pair is run four minutes, one pair is run five minutes, and one pair is run six minutes. The time which reveals the optimum packing in both of the tubes would be the amount of time to spin hemotocrits in the centrifuge. TMRMC did not provide any documentation to show that this procedure was run quarterly. In 1932, HRS advised TMRMC that the timer and constant packing of the microhematoc it centrifuge had to be checked quarterly. TMRMC responded saying that it felt that checking the timer monthly on the centrifuge and checking the speed of the centrifuge monthly was a better check than the constant packing quarterly. TMRMC also noted that such testing was in compliance with College of American Pathologists' checklist, and that quarterly packing would not assure better results. HRS failed to reply to TMRMC's response. Therefore, TMRMC assumed that HRS had accepted the alternate quality control provided by TMRMC. In that the evidence established that HRS replied to any response by a laboratory that was not acceptable, it must be concluded that the procedures followed by TMRMC provided adequate quality control. FAILURE TO PROVIDE DOCUMENTATION TO SHOW THAT CONTROLS WERE INCLUDED WITH FACTOR ASSAY: There are different factors pertaining to the clotting of blood. when Ms. Bass reviewed the records for February and March, she could not find any FDP controls, and for the month of February, she could not find any Thrombin controls. The controls are needed to insure that the reagents are performing as they should, that the methodology is performing as it should, that the technique is acceptable, and that the patient results are as accurate as possible. The records provided documentation that the controls were used in other months but not during the particular months mentioned. The problem with the documentation was that TMRMC had installed a computer system which only retained the results for a period of 45 days. Some of the supervisors did not realize that the results had to be printed onto hard copy within the 45 day period or they would be lost forever. Therefore, when Ms. Bass inspected in April, some of the documentation was missing because the section head forgot to run a hard copy of the results prior to 45 day expiration period. Nevertheless, without the documentation, it was impossible to determine whether those controls had been run during the months in question, and thus determine whether adequate quality control was provided. FAILURE TO INSURE THAT THE ACTUAL RESULTS FOR THE FIBROMETER TIMER AND STOPWATCH WERE RECORDED: TMRMC did have documentation showing the actual results of the fibrometer timer and stopwatch checks. For some reason unknown to the manager of the TMRMC laboratory, the records apparently were not seen by Ms. Bass during her inspection. The records were kept at the particular bench where the test was performed, and the manager had no idea why Ms. Bass did not see them. Had Ms. Bass asked the laboratory manager for the records, they would have been produced. The records indicate that the fibrometer timer was checked against the stopwatch for ten seconds, with an acceptable variation of plus or minus .3 seconds, and that the stopwatch was checked against the wall clock-for thirty seconds with an acceptable variation of plus or minus 1 second. Because TMRMC did document the results of the fibrometer check and the stopwatch check and did provide the acceptable limits on the records that were kept, TMRMC did not have inadequate quality controls. FAILURE TO INSURE THAT CORRECTIVE ACTION WAS CONSISTENTLY DOCUMENTED WHEN CONTROL RESULTS WERE OUT OF LIMITS. The above is the same violation alleged in violation a "e". However, this violation refers to the hematology lab, whereas "e" concerns the chemistry lab. On several dates, the controls were outside of the limits, and no documentation was provided to show what corrective action had been taken. On several other dates, there was no documentation indicating that the controls were run, and therefore there was no way to know if the results were out of limits. For the reasons set forth in the findings of fact for violation "e", TMRMC failed to provide. adequate quality control due to its failure to provide appropriate documentation of the action taken. THE CONSTANT PACKING OF THE MICROHEMATOCRIT-CENTRIFUGE IN THE FAMILY PRACTICE LAB WAS NOT CHECKED QUARTERLY: This is the same violation as alleged in violation "g", except that this refers to the centrifuge in the family practice lab rather than the centrifuge in the hematology lab. - For the reasons set forth in the findings of fact relating to violation "g", TMRMC provided adequate quality control by checking the timer and the speed of the centrifuge monthly.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that a final order be entered finding that TMRMC violated Rule 10D-41.33(2), Florida Administrative Code, as alleged in paragraphs 3(d), (e), (f), (h), and (j), dismissing those charges set forth in paragraphs 3(a), (b), (c), (g), (i) and (k), and imposing a fine of $100 for each violation, a total fine of $500.00. DONE and ENTERED this 17th day of September, 1986, in Tallahassee, Florida. DIANE A. GRUBBS, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 17th day of September, 1986.
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 Whether the Petitioner is entitled to an award of additional points sufficient to achieve a passing score on the July 1997 optometry exam.
Findings Of Fact Susan J. Summerton-Madison (Petitioner) took the July 1997 examination for licensure as an optometrist in the State of Florida. A portion of the examination tests the clinical skills of the applicant for licensure. Each applicant performs a number of tasks while two examiners observe. Prior to administration of the test, all examiners receive standardization training providing a baseline for grading the individual performance of each applicant. Examiners grade each applicant independently of each other. During the clinical part of the test, a viewing system known as a "teaching tube" is attached to the optometrist's equipment used by the applicant. The applicant performs each task twice because only one examiner at a time can observe the performance through the tube. Prior to beginning the clinical portion of the exam, the applicant and the examiners set the tube focusing mechanism so that both the applicant and the examiner have a clear view of the procedures being demonstrated. By grade report dated August 27, 1997, the Petitioner was advised that she had scored 68.80 on the clinical portion of the examination. A score of at least 75 points is required to pass the clinical portion of the examination for licensure as an optometrist. The Petitioner challenges the grading of the following questions: Section 1, questions 4a and 4b. Section 2, questions 3a, 3b, 5c, 6a, 7b, 10a, 11a, 11b, 12a, 12b, 13a, 14a, 15a, 18a, 18b, 21a, 21b, 24a, 25a, and 26a. The Petitioner asserts that her pregnancy during the examination resulted in ocular changes which caused focusing anomalies. The anomalies allegedly caused the viewing equipment through which the examiners observed her performance to be out of focus. The Petitioner received score deductions related to lack of focus on numerous questions; specifically section 2, questions 3a, 3b, 5c, 6a, 7b, 10a, 13a, 14a, 15a, 18a, 21a, 24a, 25a, and 26a. There are multiple causes of temporary ocular changes, including nervousness. Although there is evidence that pregnancy can result in ocular changes, the evidence fails to establish that any focusing problems which occurred during the Petitioner's performance on the July 1997 examination were related to pregnancy. Refocusing the viewing mechanism takes approximately five seconds. There is no evidence that an applicant is prevented from refocusing the equipment during the clinical examination. Although examiners are under no obligation to advise applicants during the test, one of the examiners observing the Petitioner suggested that she refocus the equipment. The Petitioner asserts that the request caused her to run out of time on section 2, questions 11a, 11b, 12a, and 12b. The evidence fails to establish that any problems related to insufficient time for the examination were related to the examiner's suggestion. The Petitioner asserts that points were deducted for poor focus on tasks which did not include focus as grading criteria. The evidence establishes that because the clinical portion of the test involves examination of ocular systems in a patient, almost all procedures require correct focus. The Petitioner asserts that on section 2, question 21b, ("foveal reflex") she received no points, but that another optometrist's examination of the test patient indicated that the foveal reflex was acceptable. Review of the examination indicates that the Petitioner's score was lowered because of focusing problems. The fact that a qualified optometrist determined the patient to be normal does not entitle the Petitioner to additional points or indicate that the scoring of her performance was unfair. Because examiners view separate procedures, it is not unlikely that examiners may award different scores. It is possible to evaluate the performance of examiners through use of "agreement ratings." Agreement ratings indicate the frequency of which each examiner agrees with the other examiner in testing the same applicant. The Petitioner notes that the examiners grading her performance differed in grading section 1, questions 4a and section 2, questions 3a, 3b, 7b, 10a, 13a, 14a, 15a, 18b, 21a, 21b, and 25a, and asserts that such indicates she was graded unfairly. Although the agreement ratings of the examiners who observed the Petitioner were slightly lower than average, the examiner agreement ratings fail to establish that she was graded arbitrarily or unfairly. The sample size is so small as to be subject to influence by borderline candidates, where one examiner believes an applicant's performance to be more acceptable than does the other examiner. The Petitioner asserts that on section 2, question 18b, the lack of agreement between the examiners reflects arbitrary grading because both supposedly view the same procedure through the viewing tube. The evidence fails to establish that the Petitioner is entitled to additional points or that the scoring of her performance was unfair. The Petitioner asserts that she informed the examiners that she was pregnant prior to administration of the clinical portion of the exam and that she should have received special accommodation of some type based on her condition. Procedures set forth in Rule 61-11.008, Florida Administrative Code, address special assistance to certain persons submitting to examination by the Department of Business and Professional Regulation, Office of Examination Services, which administered the examination in the instant case. Such assistance is available to persons with learning disabilities or physical handicap as defined in the rule. There is no evidence that the Petitioner sought to utilize such procedures. There is no evidence that the Petitioner's condition would have been regarded as a learning disability or physical handicap by the agency. The Petitioner asserts that an examiner exited the room while she was addressing section 1, questions 4a and 4b, and that the confusion of the departure caused the examiners to err. The evidence establishes that the scores reflect the inappropriate performance of the task involved, which involved measurement of the patient's pupil.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Department of Health enter a Final Order dismissing the Petitioner's challenge to the grading of the July 1997 examination for licensure as an optometrist. DONE AND ENTERED this 22nd day of May, 1998, in Tallahassee, Leon County, Florida. WILLIAM F. QUATTLEBAUM 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 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of May, 1998. COPIES FURNISHED: Susan J. Summerton-Madison 559 99th Avenue North Naples, Florida 34108 Anne Marie Williamson, Esquire Department of Health Building 6, Room 102 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Angela T. Hall, Agency Clerk Department of Health Building 6, Room 136 1317 Winewood Boulevard Tallahassee, Florida 32399-0700 Eric G. Walker, Executive Director Board of Optometry Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0792
