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CARL WITHERSPOON vs AGENCY FOR HEALTH CARE ADMINISTRATION, 00-003662 (2000)
Division of Administrative Hearings, Florida Filed:Miami, Florida Sep. 06, 2000 Number: 00-003662 Latest Update: Oct. 19, 2001

The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation (ACI) procedure should be approved pursuant to worker's compensation laws and rules.

Findings Of Fact Witherspoon is a 41-year-old police officer. He has worked in law enforcement for 20 years and is currently employed as a police officer for the City of Fort Lauderdale. Witherspoon was injured in an employment-related accident on September 14, 1999. The accident significantly aggravated a pre-existing injury to his left knee. At the time of the accident, Witherspoon had already had two arthroscopic surgical procedures to treat his pre- existing knee injury. He underwent a third arthroscopic surgery following the accident, and returned to work in the Spring of 2000. In addition to surgery and physical therapy, Witherspoon has been treated continuously with injections and medications in an effort to alleviate his symptoms, to no avail. At all times relevant to this case, Witherspoon has two separate injuries to the articular cartilage of his knee: one in the trochlea and one in the medial femoral condyle. Because of these injuries, Witherspoon's articular cartilage, which is necessary for proper functioning of the knee joint, has been degrading and flaking off and will continue to do so. The injuries cause him to walk with a significant limp. He is in constant pain and constant danger of his knee buckling. Witherspoon's situation is complicated by a defect in the articular cartilage of his patella. ACI was not recommended for this defect, and it is unknown how debilitating the patella injury would continue to be, if and when ACI treatment is successfully completed. Because of his injuries, Witherspoon is unable to perform the duties of a uniformed police officer. He is presently assigned to desk work, at a significantly reduced salary. Witherspoon is on an accelerated course to advanced degenerative arthritis, for which a complete knee replacement is the standard recommended treatment. Because Witherspoon is relatively young and knee replacements do not last indefinitely, the unanimous weight of medical opinion is that knee replacement should be postponed as long as possible. Witherspoon's treating physician, having exhausted all viable treatment options, referred Witherspoon to Dr. Douglas Stringham (Stringham), a Board-certified orthopedic surgeon. After reviewing Witherspoon's arthroscopic photographs and medical records, Stringham recommended that he undergo ACI. Witherspoon requested authorization for the ACI procedure, which was denied by his Employer/Carrier City of Fort Lauderdale (Employer). The dispute was referred to AHCA for review in accordance with Subsection 440.13(1)(m), Florida Statutes. AHCA consulted with Dr. Peter Indelicato (Indelicato), a Board-certified orthopedic surgeon. Indelicato rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. He further opined that there was not reliable evidence that ACI would provide significant benefit to Witherspoon's recovery and well being within the meaning of Rule 59B- 11.004(3), Florida Administrative Code. Relying exclusively upon Indelicato’s opinion, AHCA declined to order the Employer to provide ACI to the Petitioner. Upon the filing of this petition, Witherspoon was advised by the Employer that neither ACI nor any other form of intervention would be offered to him. AHCA has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Subsection 440.13, Florida Statutes. The ACI procedure which has been recommended to Witherspoon was initially developed in Sweden. Over the course of two separate surgical procedures, a sample of cartilage is first harvested arthroscopically from another area of the patient's knee joint. The sample is sent to the Boston Laboratory of Genzyme Tissue Repair, Inc. (“Genzyme”), which owns the rights to the process. Genzyme uses its proprietary process to culture the cells into an estimated five million chondrocytes over a period of approximately five weeks. Genzyme returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted in the wounded cartilage and covered with the periosteal flap. The claimed benefit of ACI is that the cartilage that is generated and implanted into the knee will approximate natural human cartilage to an extent significant enough to provide substantial benefit to the patient. Because ACI is in its infancy, questions remain about the long-term efficacy of the procedure. Other available treatments for a defect in articular cartilage of the knee include, abrasion chondroplasty, arthroscopic microfracture or drilling, osteochondral autograft surgery or “plugs”, and an osteochondral allograft using transplanted tissue from a cadaver (collectively, "conventional interventions"). Each of these procedures is, standing alone, less expensive than ACI. Each of these procedures, whether used singly or in combination, is not appropriate for Witherspoon at this time. Individually and collectively, conventional interventions afford no realistic hope of providing any noticeable relief for his symptoms, nor will they forestall the deterioration of his knee. The evidence establishes that there are no viable alternatives to ACI in the facts and circumstances of this case. Witherspoon is either not a candidate for conventional interventions, or has had such treatments and they have failed. Of the three Board-certified orthopedic surgeons who testified, AHCA's expert, who has never performed ACI, opined that Witherspoon could be treated by conventional interventions and Witherspoon's experts, who do perform ACI, testified that conventional interventions have failed and will continue to fail. There is no evidence to suggest that the testimony of any of the doctors was tainted by personal financial considerations of any kind. The ACI procedure, if successful, would be less expensive than a continuing course of short-term "housekeeping" treatments. Conventional interventions would, at most, stave off the inevitable knee replacement. They would not alleviate Witherspoon's disability in any way. Reliable evidence establishes that the ACI procedure presents the only possibility of providing Witherspoon with significant benefits toward recovery and well being. AHCA stipulates and the evidence establishes that ACI has been established to be safe. Under the facts and circumstances of this case, the benefits of the ACI procedure outweigh the risks to Witherspoon.

Recommendation Based upon the foregoing, it is RECOMMENDED that the Agency for Health Care Administration enter a Final Order approving the proposed ACI for the Petitioner. DONE AND ENTERED this 24th day of April, 2001, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 24th day of April, 2001. COPIES FURNISHED: Barry A. Pemsler, Esquire 307 Ros Centre 770 Ponce de Leon Boulevard Coral Gables, Florida 33134 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Mail Stop 3 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308

Florida Laws (3) 120.569120.57440.13
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs STEVEN M. LEVINE, M.D., 11-005617PL (2011)
Division of Administrative Hearings, Florida Filed:St. Petersburg, Florida Nov. 01, 2011 Number: 11-005617PL Latest Update: Jul. 03, 2024
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MICHAEL W. MATHESIE vs. BOARD OF CHIROPRACTIC, 89-003255 (1989)
Division of Administrative Hearings, Florida Number: 89-003255 Latest Update: Sep. 19, 1989

The Issue Has Petitioner's challenge to the failing grade he received on the November 1988, chiropractic licensure examination been rendered moot by virtue of his having retaken and passed the examination? If not, should his challenge be sustained?

Findings Of Fact Based upon the record evidence, the Hearing Officer makes the following Findings of Fact: The licensure examination administered by the Board of Chiropractic Examiners in November 1988, consisted of a written examination on Florida laws and rules and a practical examination. There were three parts to the practical examination: x-ray interpretation; technique; and physical diagnosis. To pass the practical examination, a candidate needed to receive a passing grade on each of the three separate parts of the examination. Mathesie passed the written examination on Florida laws and rules, as well as the x-ray interpretation and technique portions of the practical examination. He received a failing grade, however, on the physical diagnosis portion of the practical examination. The physical diagnosis portion of the practical examination is conducted orally. To facilitate review of this portion of the examination, it is videotaped. The videotape of the physical diagnosis portion of the practical examination in controversy in the instant case was played during the course of the hearing. Each candidate taking the physical diagnosis portion of the practical examination is asked a series of questions by two examiners who also independently grade the candidate's answers. The examiners are experienced chiropractors who have been licensed to practice chiropractic in the State of Florida for at least five years. First-time examiners receive three hours of training in testing and grading procedures and requirements. Examiners who have previously participated in the examination process are given a one or two hour refresher course. In questioning a candidate on the physical diagnosis portion of the practical examination, the examiners must cover at least four and no more than six of the following subject areas: case history; chiropractic examination; general physical examination; orthopedic examination; neurological examination; x-ray technique and diagnosis; laboratory diagnosis; nutrition; differential diagnosis; and clinical judgment. In addition, they are directed to ask practical questions designed to test the candidate's ability to function competently as a beginning chiropractor. Within these parameters, the examiners are expected to use their professional judgment in selecting the particular questions to ask the candidate. Examiners are not provided with any specific questions that they are required to pose. The examiners are also expected to exercise their professional judgment in evaluating the candidate's answers to their questions. The grading of these answers therefore is a "subjective" process reflecting the examiners' opinions as to the quality of the candidate's answers. For each of the subject areas covered during the physical diagnosis portion of the practical examination, the candidate receives a separate grade from each of the two examiners conducting this portion of the examination. A 4 is the highest grade the candidate can receive from an examiner for a covered subject area. This grade is reserved for answers which reflect exceptional expertise in the subject area. A grade of 3 out of a possible 4 (or 75%) is to be given where no more than adequate expertise is demonstrated. Where the candidate's answers demonstrate expertise that is more than adequate but less than exceptional, a grade of 3.5 (or 87.5%) is to be given. Where the candidate, through his answers, displays inadequate expertise, depending on the extent of the inadequacy, either a grade of 2.5 (or 62.5%), 2.0 (or 50%), or 1.5 (or 37.5%), is to be awarded. The lowest possible score a candidate can receive from an examiner is a 1 (or 25%). This grade is warranted where the candidate's knowledge of the subject matter is so lacking as to present a danger to the public. The candidate's overall average score on the physical diagnosis portion of the practical examination is obtained by dividing the candidate's total number of grade points by two (representing the number of examiners) times the number of subject areas covered by the examiners. To pass this portion of the examination, the candidate's overall average score must be at least a 3 (or 75%). If the candidate fails to attain such a score and contends that the examiners unfairly or erroneously evaluated his performance, the videotape of this portion of the examination is reviewed by other chiropractic experts. Based on the recommendation of these experts, adjustments may be made to the candidate's score. Mathesie was tested on six subject areas on the physical diagnosis portion of the November 1988, examination: case history; general physical examination; orthopedic examination; neurological examination; x-ray technique and diagnosis; and laboratory diagnosis. He received a failing overall average grade from the two examiners of a 2.75 (or 68.75%). Following expert review, adjustments were made which raised Mathesie's overall average grade to a 2.875 (or 71.875%). This was still less, however, than the 3 (or 75%) he needed to pass. Mathesie was awarded a 3 by both examiners for his answers pertaining to case history. Both examiners' grades were subsequently increased to a 3.5 after expert review. Mathesie was asked by the examiners "the basic headings and things that [he] would be interested in having in the case history." In responding to the question, Mathesie mentioned that he would do a "general survey of their whole body," but he failed to specify that he would inquire about urinary incontinence or genital problems, specific inquiries that are routinely made by chiropractors. In view of Mathesie's failure to specifically mention these matters, it cannot be said that it was arbitrary or unreasonable to score his answer on case history no higher than a 3.5. Both examiners gave Mathesie a 2.5 for his performance on the general physical examination segment of the test. Neither of their grades was raised following expert review. On this part of the examination, Mathesie was asked to list "the vital signs." He responded, "blood pressure, pulse, respiration rate, and temperature and some sources add height and weight." Mathesie was then asked to take the blood pressure of one of the examiners, a man approaching 40 years of age. He did so and discovered that the examiner's blood pressure was 165 over 70, which Mathesie remarked "is very high blood pressure." When asked what he would tell a patient whose blood pressure remained at this level for three consecutive days, Mathesie replied that he would advise the patient that he "had an elevated blood pressure and that he should be seen by a medical doctor for further evaluation." Blood pressure of 165 over 70 is only slightly higher than normal for a man approaching 40 years of age. Contrary to what Mathesie indicated to the examiners, it is not "very high blood pressure" and, without more, is no cause for alarm. Accordingly, Mathesie's failure to receive a grade higher than a 2.5 on the general physical examination segment of the test was not without reason or logic. On the orthopedic examination segment of the test, Mathesie was awarded a 3.0 by both examiners. Expert review did not result in a change of either of these grades. On this segment of the test, Mathesie was asked to evaluate the right knee of one of the examiners. In conducting his evaluation, Mathesie failed to examine both knees, although during the next segment of the test he did indicate, with some prompting by the examiners, that he "would compare bilaterally all the orthopedic tests." Bilateral examination is a standard, routine chiropractic practice which assists the chiropractor in determining whether the patient has a developmental or pathological problem. Inasmuch as Mathesie did not conduct such a bilateral examination when asked to assess the condition of the examiner's knee, he did not deserve to receive a grade higher than a 3.0 on the orthopedic examination segment of the test. On the neurological examination segment of the test, Mathesie received a 2.5 from one examiner and a 3.0 from the other examiner. After expert review, the 2.5 grade was raised to a 3.0. No change was made to the other examiner's grade. During this segment of the test, Mathesie initially failed to perform the patella reflex test bilaterally as he should have. It was only after one of the examiners suggested that it was necessary to determine a patient's normal reflexive action that Mathesie indicated he would "compare bilaterally all the orthopedic tests, all the neurological tests and reflexes." Mathesie further stated on this segment of the test that, in attempting to neurologically assess the patient, he would administer a cardinal gaze examination during which he would have the patient cover one eye and follow his finger with the other eye. Although a cardinal gaze examination may be administered in this fashion, the better method is to have the patient follow the moving object with both eyes. In view of the foregoing, a 3.0 was not an unreasonably low grade to give Mathesie on the neurological examination segment of the test. Mathesie received a 3.0 from both examiners on the x-ray technique and diagnosis segment of the test. Neither grade was changed following expert review. Mathesie was asked on this segment of the test to "set up a right [anterior] oblique." In describing how he would do so, Mathesie failed to give information concerning the film size and central ray. Given these omissions, Mathesie's failure to receive a grade higher than a 3.0 on this segment of the test was not without justification. Mathesie received a 2.0 from one examiner and a 2.5 from the other examiner on the laboratory diagnosis segment of the test. No adjustments were made to either of these grades. On this segment of the examination, Mathesie was asked what conclusions he would reach concerning the condition of a patient based on the results of blood tests revealing a hemoglobin of 8, a hematocrit of 25, and a RBC of 3.5. As Mathesie should have been aware, such test results reflect that the patient has suffered a severe loss of blood and therefore requires immediate medical attention. Mathesie, however, did not immediately recognize the seriousness and urgency of the matter. Having failed to do so, he cannot persuasively argue that the grades he received on this segment of the examination were unreasonably low. After receiving notification that he had failed the physical diagnosis portion of the November 1988, licensure examination, Mathesie retook and passed the practical examination.

Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Chiropractic Examiners enter a final order dismissing Mathesie's challenge to the failing overall average grade he received on the physical diagnosis portion of the November 1988, licensure examination on the ground that such challenge is now moot. Should the Board decline to dismiss Mathesie's challenge on the ground of mootness, it is RECOMMENDED that the Board enter a final order rejecting such challenge as without merit and denying Mathesie the relief he has requested. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 19th day of September 1989. STUART M. LERNER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division Administrative Hearings this 19th day of September, 1989. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 89-3255 The following are the Hearing Officer's specific rulings on the findings of fact proposed by the parties: Mathesie's Proposed Findings of Fact Accepted and incorporated in substance, but not necessarily repeated verbatim, in this Recommended Order. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. First sentence: Accepted and incorporated by reference; Second sentence: Rejected because it is more in the nature of legal argument than a finding of fact. Moreover, in order to be qualified as an expert witness in the field of chiropractic, Dr. Ordet did not have to meet the "continuous practice" requirement of Florida Administrative Code Rule 21D-11.007. To the extent that this proposed finding suggests that the Department failed to substantially comply with any prehearing discovery order issued by the Hearing Officer or that the Department otherwise engaged in improper conduct prejudical to Mathesie, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it is more in the nature of commentary on the quality of Ordet's testimony than a finding of fact. Furthermore, while it is true that Ordet's opinion regarding Mathesie's performance was necessarily subjective in nature, based on Ordet's credentials and qualifications, it appears that the opinion he gave was an informed and educated one, notwithstanding his failure to cite any specific authoritative writing supporting his opinion. First sentence: Accepted and incorporated by reference (It should be noted, however, that although Ordet "has been out of school [as a student] for many years," he is currently on the faculty of two chiropractic colleges); Second sentence: Rejected because it is more in the nature of commentary on the quality of Ordet's testimony than a finding of fact. Moreover, the Hearing Officer finds no persuasive support for the statement that Ordet "undoubtedly has not kept up with the advances in the chiropractic education." Accepted and incorporated in substance, except for the last two sentences, which have been rejected because they are not supported by persuasive competent substantial evidence. Accepted and incorporated in substance, except for the last sentence, which has been rejected because it is not supported by persuasive competent substantial evidence. Accepted and incorporated in substance. Accepted and incorporated in substance, except for the last two sentences, which have been rejected because they are not supported by persuasive competent substantial evidence. Rejected because it is not supported by persuasive competent substantial evidence. To the extent that this proposed finding suggests that Mathesie should not have had points taken off for indicating that he would tell a patient with a blood pressure reading of 165 over 70 to see a medical doctor, it has been rejected because it is not supported by persuasive competent substantial evidence. First sentence: Rejected because it constitutes a statement of the law rather than a finding of fact; Second sentence: Rejected because it is not supported by persuasive competent substantial evidence. Accepted and incorporated by reference. Rejected because it is not supported by persuasive competent substantial evidence. Accepted and incorporated in substance. (It should be noted, however, that although Mathesie did state "on the video that all tests would be done bilaterally," he made this statement following the orthopedic examination after one of the examiners suggested, through his questioning, that it was important to determine what was "normal" for the patient.) To the extent that this proposed finding suggests that Mathesie should have been awarded a grade higher than a 3.0 on the neurological examination segment of the test, it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it is not supported by persuasive competent substantial evidence. To the extent that this proposed finding suggests that Mathesie should have been awarded a higher overall average grade on the physical diagnosis portion of the November, 1988, licensure examination than a 2.875 (or 71.875%), it has been rejected because it is not supported by persuasive competent substantial evidence. Rejected because it is more in the nature of a request for relief than a finding of fact. Rejected because it is more in the nature of a request for relief than a finding of fact. The Department's Proposed Findings of Fact Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance, except to the extent that it indicates that "[c]ase history was raised to a 2.5 by both examiners." The uncontradicted evidence reveals that Mathesie originally received a 3.0 from both examiners on case history and that both of these grades were subsequently raised, following expert review, to a 3.5. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated in substance. Accepted and incorporated by reference. COPIES FURNISHED: Michael W. Mathesie 8933 Northwest 51st Place Coral Springs, Florida 33067 E. Harper Field, Esquire Deputy General Counsel Department of Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 Pat Guilford Executive Director Board of Chiropractic Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792

Florida Laws (3) 455.217455.229460.406
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INTERNATIONAL EVALUATION CONSULTANTS, INC. vs BOARD OF PHYSICAL THERAPISTS, 93-000464 (1993)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Jan. 28, 1993 Number: 93-000464 Latest Update: Aug. 04, 1994

Findings Of Fact Roland H. Gaines has been registrar for Florida A&M University since 1990. Mr. Gaines has worked at Florida A&M University in the registrar's office continuously since 1968, serving as supervisor of records and registration, assistant deputy registrar, assistant registrar and, currently, registrar. Mr. Gaines is the sole incorporator, director and officer of International Evaluation Consultants, Inc., which is the Petitioner in this case. Florida A&M University has a physical therapy program approved by the American Physical Therapy Association. Mr. Gaines is familiar with the licensing requirements established by the Board of Physical Therapy, and has evaluated numerous transcripts of foreign students applying to Florida A&M University in order to determine their eligibility to take the physical therapy examination. Mr. Gaines has evaluated over 100 foreign transcripts in order to determine if the applicants met the requisite criteria to take the licensing examination of the Florida Board of Physical Therapy. A portion of the evaluations mentioned in Paragraph 4, above, were submitted by Mr. Gaines in his individual capacity as distinguished from evaluations Mr. Gaines performed for Florida A&M students as registrar of the university. Because of the differences in the manner of their submission, the Board was aware that Mr. Gaines had evaluated such transcripts in his individual capacity. None of the evaluations submitted by Mr. Gaines were returned as being incomplete or incorrect. Subsequent to Marvin Harris becoming executive director of the Board of Physical Therapy, the question of Mr. Gaines submitting evaluations of non- students was brought to the attention of the University, and Mr. Gaines was requested to stop this practice in his individual capacity because of Harris' complaint. Mr. Gaines incorporated as International Evaluation Consultants, Inc., and requested the Board for designation as a recognized evaluator of the educational credentials of foreign students. The Board denied the Petitioner's request for certification as an evaluator stating that the Petitioner did not meet the standards of Rule 21MM- 3.001(3), Florida Administrative Code. The Board's denial does not specifically indicate which of the standards the applicant fails to meet. The Board did not explicate the standards used by the Board in assessing the three (3) agencies named in Rule 21MM-3.001(3), Florida Administrative Code.

Recommendation Based upon the consideration of the facts found and the conclusions of law reached, it is, RECOMMENDED: that the Board designate the Petitioner as an evaluator of the credentials of foreign graduates to determine if they have education and training equivalent to a bachelor's degree in physical therapy. DONE and ENTERED this 2nd day of November, 1993, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of November, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-464 The proposed findings of the parties were read and considered. The following states which of these findings were adopted, and which were rejected and why: Petitioner's Findings: 1 through 3. Adopted in paragraph 1. Adopted in paragraph 2. Adopted in paragraph 3. Adopted in paragraph 4. Adopted in paragraph 5. Subsumed in paragraphs 3 and 5. Adopted in paragraph 6. 10.-13. Subsumed in paragraph 5. Rejected as hearsay. Adopted as paragraph 7. Respondent's Findings: Adopted as paragraph 8. Adopted as paragraph 9. 4.-10 Preliminary Statement. Adopted as paragraph 11. Adopted as paragraph 1. Conclusion of Law.- COPIES FURNISHED: Cecil E. Howard, Esquire 320 Williams Street Tallahassee, Florida 32303 Michael A. Mone', Esquire Assistant Attorney General PL-01, The Capitol Tallahassee, Florida 32399-1050 Jack McRay Acting General Counsel Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Dr. Marm Harris, Executive Director Board of Physical Therapy Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0789

Florida Laws (3) 120.57486.025486.031
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DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs ALEXANDER D. J. BRICKLER, III, M.D., 02-000340PL (2002)
Division of Administrative Hearings, Florida Filed:Tallahassee, Florida Jan. 25, 2002 Number: 02-000340PL Latest Update: Mar. 13, 2003

The Issue Should Petitioner discipline Respondent's license to practice medicine?

Findings Of Fact At the times relevant to the inquiry Petitioner was the state agency charged with regulating the practice of medicine in Florida, pursuant to Section 20.43, Florida Statutes, and Chapters 456 and 458, Florida Statutes. Respondent is and has been at all times material hereto a licensed physician within the state of Florida, having been issued license No. ME0045474, effective December 28, 1984. Respondent's last known address is 1401 Centerville Road, Suite 202, Tallahassee, Florida 32308. Respondent is board-certified in obstetrics and gynecology. The board certification is by the American Board of Obstetrics and Gynecology. Respondent is a fellow of the American College of Obstetricians and Gynecologists. Respondent received his undergraduate degree from Florida State University and his medical degree from Howard University. His training at Howard University included a four- year residency program from 1982 to 1986. Respondent holds staff privileges at Tallahassee Memorial Hospital (TMH) in Tallahassee, Florida. Patient A.G. Patient A.G. began treatment with Respondent in 1998 and continues as Respondent's patient. A.G. is an Hispanic female who is not proficient in English. When seen by Respondent in his office she has been accompanied by an interpreter that would allow Respondent to discuss details of her health care in English for translation into Spanish for the patient's benefit. Respondent's understanding of Spanish is limited to education in high school and a year at the university. He has the ability to describe some matters that are pertinent to gynecologic practice or obstetric practice and in particular as it relates to telling patients, for example "how to push and when not to push." The record does not reveal that Respondent has the ability to discuss A.G.'s overall health care in Spanish, her language. A.G.'s husband, T.Q., who accompanied her at relevant times principally spoke Spanish and not English. He is somewhat proficient in English. On June 16, 1999, A.G. had an office appointment with Respondent. At that time A.G. had undergone gallbladder surgery but her pelvic pain persisted. In consultation on that day it was decided that A.G. would undergo diagnostic laparoscopy to explore the reason for her chronic pelvic pain. Through the discussion the patient was told that biopsies of the pelvic anatomy might be performed during the procedure and that any problems that could be addressed through laparoscopy would be addressed as Respondent felt comfortable in carrying out that correction. Otherwise, Respondent said that he would "take pictures" and "get out of the case" with the decision to offer further treatment left for another time. Patient A.G. had been referred to Respondent for her persistent pelvic pain following an examination on April 27, 1999, that had been made by Margaret Cantor, a Nurse/Mid-Wife and Registered Nurse. She conducted a pelvic examination of the patient that date. The examination included the use of speculum to examine the cervix and vagina in the interest of looking for abnormalities, lesions, growths, and discolorations. No cervical lesions were found in this examination. A pap smear taken at the time revealed normal results with some inflammation. Diagnostic laparoscopy is a surgical procedure involving an incision in the abdominal wall through which a scope is inserted to visualize the abdominal cavity. Typically the workup for performing a diagnostic laparoscopy would include use of ultrasound, pelvic examination, and a pap smear. Possible complications in this procedure include vascular injury, bowel injury, bladder injury, infection, and bleeding. Preliminary to the diagnostic laparoscopy it is the custom and practice in the medical community to perform a vaginal examination with the use of a speculum. On July 1, 1999, patient A.G. was seen by the Respondent in his office for her pre-operative check. On this occasion A.G. was unaccompanied by a translator. Nonetheless, Respondent was able to perform a brief physical and obtain a history with the assistance of A.G.'s husband. Respondent listened to the patient's heart and lungs and performed a bi- manual examination in which one or two fingers were inserted in the vagina and with a hand on the abdomen compression was performed on the pelvic viscera, uterus, tubes, and ovaries and the lower section of the pelvis. Nothing significant was observed in the patient since last seen. On July 1, 1999, an employee in Respondent's office witnessed patient A.G. sign a consent form allowing the diagnostic laparoscopy. The consent form makes no reference to the agreement for Respondent to perform a loop electrocautery excision procedure, referred to by abbreviations as a "LEEP" conization biopsy procedure or a LEEP cone. No evidence of such consent is contained in patient A.G.'s medical records maintained at Respondent's office. The diagnostic laparoscopy was to be performed at TMH. On July 1, 1999, Patricia Charbonneau, a clinical nurse at the hospital, reviewed a consent form with patient A.G. concerning the diagnostic laparoscopy for the purposes of that facility. Nurse Charbonneau was aware of the scheduling of the diagnostic laparoscopy by reference to the history and physical prepared by the Respondent. This conference involved the discussion of potential risks and complications of the laparoscopy. No discussion was conducted concerning possible risks and complications of a LEEP conization biopsy. The consent form from TMH pertaining to patient A.G. and the diagnostic laparoscopy stated "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure, I request and authorize my physician to proceed." Nurse Charbonneau was left with the impression that the patient understood the explanation concerning the upcoming procedure and gave her consent. Ms. Charbonneau was assisted in this communication by A.G.'s husband. No discussion was held concerning the performance of a LEEP cone biopsy, in that the permit from Respondent made no mention of that procedure. Ms. Charbonneau took steps for an interpreter to be available the next morning when the surgery was to be performed given the nature of the surgery, the use of anesthesia and the desire to have "everything" reviewed again. A LEEP conization is a form of biopsy performed either in an office or hospital setting with anesthesia. The cervix is examined with the assistance of a speculum. Lugol solution is placed on the cervix to identify any abnormal cells and an excesion is made by shaving a small piece of the cervix for examination. The workup for LEEP conization includes a pap smear and a colposcopy. The performance of LEEP conization presents potential risks and complications related to infection, endometrious, bleeding, cervical stenosis, and cervical incompetence. On July 2, 1999, patient A.G. came to the TMH outpatient surgery center for her scheduled diagnostic laparoscopy to be performed by Respondent. She was the fourth patient on a schedule of surgeries to be performed by Respondent on that date. Respondent was conversant with the sequence of surgeries to be performed. Patient A.G. was placed in a holding area in the outpatient surgery center to prepare her for her surgery and to await transport to the operating room. Sometime before moving the patient to the operating room Respondent saw the patient in the holding area. Respondent addressed patient A.G. by saying hello and asking her how she was doing. This was not a visit intended to educate the patient and was not involved with any other medical purpose. At the time the patient's husband was with her during this brief encounter which was intended to confirm that the patient was there for the surgery as had been previously arranged. Several hours may have passed between the time Respondent saw patient A.G. in the holding area and when he next encountered the patient in the operating room. Respondent also saw patient N.C. in an adjacent cubicle to where patient A.G. was located while the patients were awaiting their surgery. Patient N.C. was the third patient on the schedule, there for the performance of a LEEP conization biopsy. Respondent followed his surgical schedule for the first two patients in the intended sequence. Some delay was occasioned by a problem experienced in the surgery performed on the second patient. Valerie Anne Lazzell, M.D., is an anesthesiologist licensed to practice in Florida. She is employed by Anesthesiology Associates of Tallahassee, Florida. It was intended that she provide anesthesia during Respondent's performance of the diagnostic laparoscopy for patient A.G. It was anticipated that the patient be subjected to general anesthesia which involves a rapid loss of consciousness and blocks the sensory, mental and motor functions of the patient. A general anesthesia can be provided by using an endotracheal tube, with a mask or with an LMA. This is as distinguished from the use of a neurolept employed in most instances when performing LEEP conization biopsies. In that setting the patient is generally anesic, not really aware, and has analgesia "on board." The use of a neurolept promotes a pain-free state of immobility and an insensitivity to pain and is usually accomplished by use of IV medications. From the record, it appears that Jean Mauch, C.R.N.A., with Anesthesiology Associates was scheduled to provide anesthesia by neurolept for the third patient N.C. who was scheduled for LEEP conization biopsy. Patient A.G. at the time in question was 4'9" tall and weighed 103 pounds. Patient N.C., an African-American woman was 5'2" tall and weighed 242 pounds. Their skin tone was similar in color. Dr. Lazzell saw patient A.G. before the patient was taken for surgery. In this examination the doctor filled out the patient's airway, listened to her heart and lungs, and considered the patient's ASA classification which was one of good health. Dr. Lazzell considered the plan for anesthesia with an endotracheal tube. She gained the assistance of a Dr. Becker who was fluent in Spanish in explaining the use of anesthesia to the patient. Dr. Lazzell sought Dr. Becker's assistance when the hospital did not make an interpreter available. Dr. Lazzell discussed the possible risks and complications of use of this form of anesthesia and a consent form was signed and dated. While this assessment was being made A.G.'s husband was in attendance. It was Dr. Lazzell's expectation that the patient A.G. would next be seen as scheduled when the nurse anesthetist called Dr. Lazzell to the operating room to intubate patient A.G. in association with the provision of anesthesia for the diagnostic laparoscopy. Jean Mauch, C.R.N.A., when performing her duties in the operating room setting at TMH outpatient surgery center was expected to induce anesthesia, maintain the anesthesia, monitor vital signs, treat untoward events during surgery and maintain fluids in the patient while under the supervision of the physician, in this instance, Dr. Lazzell. Nurse Mauch was principally responsible for providing the anesthesia for the third procedure on patient N.C., the LEEP conization biopsy. This included preparation in the operating room of medications and other related tools and supplies. The third procedure, the LEEP conization biopsy for N.C., was referred to on a typed surgical schedule in the preoperative desk in the outpatient surgery center. Having checked the schedule Nurse Mauch obtained the chart for N.C. and went to the cubical, not of N.C. but A.G. When Nurse Mauch arrived at A.G.'s cubical, Jamie Martin, R.N., the pre-op nurse and Dale Dunsmore, R.N., the circulating nurse, were there. Nurse Dunsmore and Nurse Mauch arrived at the cubicle where patient A.G. was located at about the same time. When arriving at the cubicle for patient A.G., Nurse Mauch had in mind that the process was one in which she was getting ready for the surgery to be performed on patient N.C. While in the cubical Nurse Mauch introduced herself to the person she believed to be the patient N.C., at which time Nurse Dunsmore said that the patient only speaks Spanish. Nurse Mauch recalls that a translator was not available for assisting in any communication with patient A.G. Realizing that Nurse Dunsmore was checking the armband for identification, the reference to the fact that the patient only spoke Spanish did not cause Nurse Mauch any concern. Nurse Mauch never heard Nurse Dunsmore orally refer to patient A.G. by name. Nurse Mauch continued with her presentation by commenting that she was the nurse anesthetist who was going to put the patient to sleep. Patient A.G. nodded her head in response to Nurse Mauch's physical gesture that the patient was going to be put to sleep. Beyond that point Nurse Mauch and Nurse Dunsmore took patient A.G. to the operating room ostensibly as the third patient on the schedule for provision of a LEEP conization biopsy wherein Nurse Mauch would provide the necessary anesthesia. The chart for N.C. was brought to the operating room. Before the patient was removed from the cubicle Nurse Martin provided pre-op medication to patient A.G., phenergan robinul. The fact that Nurse Martin was giving preoperative medication and that Nurse Dunsmore was checking the armband on what turned out to be patient A.G. led Nurse Mauch to believe that patient A.G. was patient N.C. the third scheduled patient, according to Nurse Mauch. As Nurse Mauch recalls, when the Respondent entered the operating room where the third scheduled procedure was to be performed he checked the chart for patient N.C. Respondent went out and washed his hands, returned and started the procedure. At the end of the procedure Nurse Mauch recalls Respondent commenting that the next patient speaks only Spanish, to which Nurse Mauch said, "No, this patient," meaning the patient who had been subjected to the procedure is the one who speaks Spanish. Respondent replied "I must be mixed up." Nurse Mauch recalls Dr. Lazzell arriving at the door of the operating room with patient A.G.'s chart. Dr. Lazzell looked surprised to find the circumstances. Nurse Mauch told Dr. Lazzell that this is the neurolept, the case involving the LEEP conization biopsy. Dr. Lazzell commented that "No it isn't." Nurse Mauch heard Dr. Lazzell ask Respondent, "What procedure did you do?" Respondent replied "LEEP conization." Dr. Lazzell said "No, this was supposed to be the diagnostic laparoscopy." Nurse Mauch observed Respondent leave the room and return. Patient A.G. was re-preped and the diagnostic laparoscopy scheduled to be provided was performed with the patient being intubated by the use of an endotracheal tube. Nurse Martin in her capacity as pre-op nurse was responsible for receiving patients and getting the patients ready for administering medications that were prescribed and getting IVs and things started on the patients prior to the patients being sent to the operating room. She recalls performing pre- operative duties on the patient A.G. Nurse Martin was familiar with the schedule of patients, the sequence. She understood that patient A.G. was the fourth patient in the schedule and provided the pre-anesthetic to patient A.G. in preparation for the operation. This involved the use of phenergan. Nurse Martin made no mistake in identifying patient A.G. when providing care. Nurse Martin heard Nurse Dunsmore identify patient A.G. in Nurse Martin's presence and agreed with that identification. Nurse Martin had seen the patient A.G. before the occasion at which Nurse Mauch and Nurse Dunsmore were there with the patient in Nurse Martin's presence and the patient A.G. was taken to the operating room. Nurse Martin had reviewed patient A.G.'s chart earlier in caring forward responsibilities for preparing the patient for the operation. Nurse Dunsmore identified her duties as circulating nurse at TMH outpatient surgery center as being related to setting up rooms for surgeries, transporting patients from pre-op holding areas, identifying patients, verifying surgeries, verifying allergies, and so forth. Ordinarily Nurse Dunsmore in performing her duties would read the chart of the patient scheduled for a procedure to make certain that all permits were signed. She would then go to where the patient was being held, introduce herself to the patient and ask for identification, verifying the surgery that is scheduled for the patient, and perform other related assignments. In performing her duties Nurse Dunsmore would accompany the patient with the anesthesiologist to the operating room. The method of identification in effect at the time in question would be to compare an addressograph card which accompanied the patient's chart with the information on an identification bracelet worn by the patient. Nurse Dunsmore verified that the operating room for the third procedure was set up for a LEEP conization biopsy. After the second procedure on the schedule, Nurse Dunsmore recalls that she went to patient A.G.'s room. However Nurse Dunsmore had handed Nurse Mauch patient N.C.'s chart. Nurse Mauch carried the chart to patient A.G.'s cubicle. The two nurses essentially entered the cubicle together. Nurse Martin and patient A.G.'s husband were already there. Nurse Martin left the cubicle shortly thereafter. Nurse Dunsmore introduced herself to the patient and reached for the patient's identification bracelet and read it out loud. The patient smiled and nodded in response. In turn the patient's husband smiled and nodded in response. Patient A.G. was then taken to the operating room by Nurse Dunsmore and Nurse Mauch. The patient was sedated by Nurse Mauch and positioned for provision of the LEEP conization biopsy. Nurse Dunsmore observed the Respondent enter the operating room and look at the chart which was in relation to patient N.C., not patient A.G. Nurse Dunsmore saw Respondent leave the operating room to scrub. Nurse Dunsmore was in attendance when the procedure was performed. Nurse Dunsmore recalls Dr. Lazzell entering the operating room at the end of the procedure with the chart belonging to patient A.G. and the realization by those in attendance that the chart in the operating room was for N.C., whom they understood to be undergoing the procedure when in fact the patient undergoing the procedure was A.G. Diane Jordan was a surgical technician assigned to assist in the third procedure, the LEEP conization biopsy. She recalls the patient being put to sleep by Nurse Mauch and the patient being prepared for the procedure. The patient was covered by draping towels across the upper portion of the thighs. A blanket was placed over the patient's torso. The patient was placed in the lithotomy position allowing observation of the patient's buttocks, vulva, vagina and external pelvic organs. The patient had a mask on her face and a surgical hat to cover her hair. All of these arrangements had been made before Respondent entered the operating room. Ms. Jordan recalls that the chart in the room was for N.C., the patient anticipated to undergo the LEEP conization biopsy. Ms. Jordan did not realize that the patient in reality was patient A.G. Ms. Jordan recalls that the Respondent when entering the room asked is this "such and such" in relation to a LEEP conization biopsy and that Nurse Dunsmore replied in the affirmative. Ms. Jordan remembers Respondent looking at the chart for N.C. and signing it. Ms. Jordan was in attendance while the procedure was performed. Ms. Jordan heard Respondent mention something about a lesion before he started. Ms. Jordan provided medication to be injected during the LEEP conization. Ms. Jordan identified the fact that a specimen was obtained which was given to her and provided to the nurse to send to pathology for evaluation. When Respondent entered the room for what he anticipated to be the third procedure what he asked specifically was "Is this Ms. C our case for the LEEP?" referring to the LEEP conization to be performed on patient N.C. That is when Nurse Dunsmore responded in the affirmative. After inquiring about the identification of the patient in association with the nature of the procedure Respondent expected to perform and in receiving an affirmative response, Respondent took no further steps to personally confirm the identity of the patient. Respondent opened the chart that was patient N.C.'s chart. Respondent took a drawing from his pocket that a Dr. Thompson had made of patient N.C.'s cervix when he had treated the patient. The drawing was in association with a colposcopy. Respondent intended to compare that drawing with what was observed in the patient during the performance of the LEEP conization biopsy in locating the suspected pathology. In proceeding with what he considered to be the third scheduled procedure for N.C., Respondent placed the speculum, applied the tenaculum and observed what looked to be a lesion that roughly approximated what he anticipated it would be based upon the drawing from Dr. Thompson. Respondent applied Lugol's solution and proceeded with the LEEP conization biopsy. Having applied the solution there was an indication of some pathology in roughly the position as the drawing had depicted. Respondent obtained the sample from the cervix. The size of the specimen was less than the diameter of a dime with a depth or thickness of about two dimes. The performance of the LEEP conization biopsy took less than five minutes. As Respondent finished Dr. Lazzell came to the operating room and informed Respondent that this was not the patient the he thought he was treating. Having been told by Dr. Lazzell that there was a misidentification, Respondent for the first time while engaged with the patient in the operating room proceeded to the front of the table and looked at the patient while the patient was being unmasked. By doing so Respondent discovered that indeed the patient had been misidentified and that he had actually performed surgery on patient A.G., not patient N.C. Respondent left the operating room and informed patient A.G.'s husband of the problem. Respondent returned to the operating room. The patient was provided anesthesia by Dr. Lazzell and the diagnostic laparoscopy that was scheduled was performed. Notwithstanding that it was never intended that Respondent perform a biopsy on patient A.G. from the cervix, Respondent expresses the opinion that if the physician encounters a visible lesion some form of biopsy is in order. Respondent expresses the opinion that in performing procedures such as a diagnostic laparoscopy greater latitude is afforded in terms of what the physician can do when he or she discovers "What's amiss with the patient." This in Respondent's view is because the patient is going into the procedure with the understanding that there may be an unanticipated problem and if the unexpected problem can be addressed, it should be taken care of. Of course this assumes that the biopsy that was performed on patient A.G. was in association with the scheduled diagnostic laparoscopy, when in fact the biopsy was the product of happenstance, in that, Respondent when addressing what he considered to be the condition in the patient N.C., by chance observed a similar condition in the patient A.G. Respondent concedes that prior to patient A.G.'s arrival at the outpatient surgical center that LEEP conization was not an indicated procedure for that patient. The biopsy that was performed was with the misapprehension as to the patient whose needs were being addressed, not merely an unanticipated circumstance in a patient whose identity was established when Respondent performed the biopsy. This was not an additional surgical procedure that came about in connection with the scheduled diagnostic laparoscopy; it was perceived by Respondent as the intended surgery being performed on a different patient when the case began. As a consequence it is the planned- for diagnostic laparoscopy which became the additional procedure. Nonetheless, Respondent tries to explain his result by expressing the opinion that other unexpected and unplanned-for procedures may be undertaken in the instance "Within the realm of the comfort level of the physician and the patient ahead of time; where they know each other, other things can be done as well." Respondent believes that the ability to proceed with the biopsy on patient A.G. while thinking that he was responding to the case involving patient N.C. is implicit and is promoted by "A feeling of trust that we had developed at the point in time." This refers to the point in time at which the other surgery, the diagnostic laparoscopy was being discussed with the patient A.G. The type of pathology that was encountered by Respondent with patient A.G. that led to the biopsy was compatible with condyloma with warty atypia. That is what Respondent observed and collected for evaluation. The laboratory confirmation of the specimen was performed by Dr. Woodard Burgert, a board-certified anatomic and clinical pathologist. In his assessment Dr. Burgert observed that the cone biopsy in question was compatible with condyloma with warty atypia. There was no significant dysplasia. Expert Opinions Dr. Edward Zelnick is a board-certified obstetrician and gynecologist who practices in Florida. He has hospital privileges at Hollywood Medical Center and Memorial Regional Hospital. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. In the instance where pathology is found in examining the cervix, Dr. Zelnick believes that action should be taken in addressing that pathology, but only in the instance where the pathology has been discussed with the patient and the appropriate alternative treatment has been discussed. Absent an emergency it is necessary to provide the patient the alternative to surgery and identify the risk of surgery. Absent life-threatening circumstances, a biopsy such as that performed on patient A.G. should not be performed without the patient's consent, which had not been given. Dr. Zelnick further describes the instance in which a biopsy in a case such as this would be in order, would be in relation to an instance in which it appeared that the circumstance was an immediate threat to the health of the patient that needed to be addressed. None of the exigent circumstances existed in this case. Therefore, Dr. Zelnick expresses the opinion that the performance of the biopsy by Respondent did not meet the expected standard of care. Based upon his familiarity with the form of consent in this case which states, "If any unforeseen condition arises and additional surgery is deemed medically necessary during my procedure I request and authorize my physician to proceed," Dr. Zelnick believes that the physician's responsibility there is to respond during the course of the surgery, if medically necessary, to such matters as repairing of a blood vessel that has been cut or damage to an internal organ or bowel. None of those circumstances were associated with the biopsy performed on the patient A.G.. While Dr. Zelnick delegates patient identification to surgical staff or nursing staff, he believes that the ultimate responsibility for patient identification to make certain that the right operation is performed on the proper patient resides with the surgeon. To do less is to practice below the standard of care universally accepted and a matter of common sense. According to Dr. Zelnick, Respondent did not meet that standard when performing the biopsy on patient A.G. who was misidentified. Whatever rules and procedures may be in place setting standards for identification in a hospital, Dr. Zelnick does not believe those standards abrogate the duty of the physician to properly identify the patient. What is expected of a physician is 100 percent certainty as to who the proper patient is and to assure that the proper procedure is carried out on the proper patient. The method of arriving at that determination is not significant, in Dr. Zelnick's view. Dr. Roberto Fojo is a board-certified obstetrician and gynecologist licensed to practice medicine in Florida. He has hospital privileges at Jackson Memorial and North Shore Medical Center in South Florida, and he is affiliated with the University of Miami, Department of Obstetrics and Gynecology, Division of Gynecology. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He does not view a diagnostic laparoscopy as being intended to discover and diagnose cervical lesions, where, as here, the lesion is on the surface of the cervix and vagina. A diagnostic laparoscopy is not intended to promote an examination of the cervix, according to Dr. Fojo. Dr. Fojo is familiar with the consent form executed by patient A.G., the language previously described. He has seen that language before or something similar to it and considers it part of the standard surgical consent in connection with a diagnostic laparoscopy that was intended in this case. The consent is designed to allow the surgeon to address matters such as puncture of the bowel or a problem with a major artery or veins or scar tissue or adhesions. This consent would not include addressing lesions on the cervix. A LEEP conization procedure is not an accepted procedure to perform in the patient undergoing diagnostic laparoscopy unless the LEEP conization had already been discussed and there was a problem with the cervix that the patient knew about. There, in Dr. Fojo's perception, the patient would be undergoing what he refers to as dual procedure. Dr. Fojo does not believe that surgery should be performed on a patient absent the patient's consent as being part of the original procedure or in an emergency. The LEEP conization biopsy by Respondent was not related to the consent that had been provided nor pertaining to an emergency. In this sense, Dr. Fojo expresses the opinion that Respondent failed to meet the standard for medical practice when performing the LEEP conization biopsy on Patient A.G. Dr. Fojo believes that a surgeon should ascertain without any doubt that the patient in the room is a patient that he or she should be performing surgery on, the appropriate surgical procedure. This need for identification is an independent responsibility of the physician and may not be delegated. It requires 100 percent accuracy, according to Dr. Fojo. Dr. Fojo holds to the opinion that the physician is responsible for the identification regardless of his or her efforts that may have been compromised by others in attempting to properly identify the patient and perform the indicated procedure. He believes this to be common medical practice. Respondent was not within the standard of care in performing the LEEP conization procedure on patient A.G. under Dr. Fojo's assessment. Dr. Michelle McCallanahan is a board-certified obstetrician and gynecologist who is licensed in Florida and practices in Jacksonville, Florida. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. The consent form executed by patient A.G. is not unfamiliar to Dr. McCallanahan. Her perception of this consent language is that it relates to complications that occur during the course of the diagnostic laparoscopy that were not foreseen and constitute an emergency requiring an immediate procedure to correct the condition. Examples are vascular injuries to vessels, bowel injury, bladder injury, infection and bleeding. By contrast, lesions on the cervix do not constitute an example of an unforeseen circumstance. Dr. McCallanahan expresses the opinion that an appropriate workup for LEEP conization was not done for the patient A.G. Nonetheless, there are some circumstances in which it would not be violative of the standard of care to perform LEEP conization without conducting a workup. That circumstance would be in the instance where the lesion that was observed was highly suggestive of cervical cancer, according to Dr. McCallanahan. The case that Respondent was presented with did not constitute such a condition. Ordinarily, the standard of care contemplates the discussion of possible risks or complications associated with LEEP conization procedures before performing them. According to Dr. McCallanahan it would be appropriate to perform a surgical procedure without discussion of the risks and possible complications in an emergency when the patient was unconscious and could not give consent in advance. Those are not the facts here. While Dr. McCallanahan relies upon the assistance of other persons within the surgical and nursing staff, she expresses the opinion that the ultimate responsibility for patient identification prior to the performance of surgery resides with the physician. She believes that it is below the standard of care to not correctly identify the patient before the procedure is done and perform an improper procedure or non- consenting procedure on that patient, as was the case here. Dr. Jana Bures-Forstheoefel is a board-certified obstetrician and gynecologist who is licensed in Florida. She practices in Tallahassee, Florida, and has privileges at TMH and performs surgeries in the outpatient surgery center. She is familiar with the procedures involved in patient A.G.'s care based upon her own experience. She is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. She believes that Respondent met the standard of care for identifying patient A.G. before performing surgery on the patient. The method used by Respondent to identify the patient was common to the practice of other physicians who performed surgeries in that setting, according to Dr. Forstheoefel. In the event that Dr. Forstheoefel was performing a diagnostic laparoscopy and observed a cervical lesion she would evaluate the condition to include the performance of a biopsy, the most common method for cervical biopsy being a LEEP conization. Notwithstanding the lack of specific consent by the patient for Respondent to perform the LEEP conization, Dr. Forstheoefel holds to the opinion that it was correct to biopsy, given what was observed in the patient. The prospect that a physician would be 100 percent accurate in identifying a patient undergoing surgery is not humanly possible and is a standard that should not be imposed upon a physician in Dr. Forstheoefel's opinion. She considers that the matter of proper identification preoperatively is a team effort. One person should not be solely responsible for all things in making certain of the patient's safety and assuring that the right thing is done. Dr. Kenneth John McAlpine is a board-certified obstetrician and gynecologist. He is licensed in Florida. At times relevant he performed surgeries at the TMH outpatient surgery center. He is familiar with the procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for that patient. He believes that Respondent met the standard of care in identifying the patient A.G. before performing the surgery and in performing the LEEP conization on that patient. Although Dr. McAlpine has not experienced a situation in which he observed a reason to do a LEEP conization in a diagnostic laparoscopy case, where consent for LEEP conization had not been given ahead of time, he does not question the decision to address the condition observed, such as in the case at issue. From his point of view, it was acceptable to do a LEEP conization biopsy to address the lesion. Although no prior indication existed before the lesion was observed during the procedure Dr. McAlpine would not want to ignore the lesion. Dr. McAlpine believes that the process that Respondent undertook in identifying the patient A.G. before surgery was consistent with practices in effect at the hospital, this included reliance on staff in the operating room. Dr. McAlpine does not believe that it is necessary for a physician to be 100 percent accurate in the identification as a person ultimately in charge. No matter as to the facts, he sees the issue of the identification being a multi-disciplinary approach among health care providers. Dr. David O'Bryan practices obstetrics and gynecology. He is licensed in Florida. At times relevant he performed surgeries at TMH outpatient surgery center. He is familiar with the type procedures involved in patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. The method employed by Respondent in identifying the patient was consistent with the practice used in the immediate medical community at the time, according to Dr. O'Bryan. Dr. O'Bryan believes that the Respondent performed the appropriate surgery on Patient A.G. For Dr. O'Bryan, what is more important in addressing the patient's needs is the apparent pathology, not the consent that may have been provided by the patient in advance of the procedure. It would be negligent not to address the lesion on the cervix in his view. The pathology present determines the response even without a consent for the procedure. Dr. O'Bryan did not consider that the pathology constituted an issue of life or death. The fact that the LEEP conization biopsy was not planned was less significant than the need to address the pathology. It does not matter if the patient were A.G. or N.C. or some other patient, Dr. O'Bryan believes that it was appropriate to perform the biopsy. Dr. O'Bryan believes that the surgeon bears a great deal of responsibility in patient identification, but the ultimate responsibility for identification does not reside with the physician or any other operating room staff member in Dr. O'Bryan's assessment. Dr. O'Bryan does not conceive that there can be any greater comfort in the identification than in the instance where the "operating room crew" tells the physician who it is and the physician has a chart in his hands which indicates that it is the same patient as the operating staff has identified and the pathology that was found is consistent with what had been anticipated according to the patient chart and the staff identification. Nothing in medicine involves the imposition of a 100 percent standard of care to include properly identifying the patient preoperatively, according to Dr. O'Bryan. Dr. Roberto Morales is a board-certified obstetrician in gynecology licensed to practice in Florida. At times relevant, he performed surgery at the TMH outpatient surgery center. He is familiar with the type procedures involved in Patient A.G.'s care based upon his own experience. He is sufficiently familiar with the facts in this case to render an opinion concerning Respondent's level of care for the patient. Dr. Morales believes that Respondent met the standard of care for identifying the patient A.G. in that hospital and in other places as well. Dr. Morales believes that the patient was correctly identified by Respondent earlier in the day and that the incorrect patient was brought back to the operating room. Under those circumstances, Respondent did what was appropriate to identify the patient in the performance of the LEEP conization on patient A.G. and was within the standard of care, according to Dr. Morales. Assuming the patient was scheduled for a diagnostic laparoscopy, if during the examination, visualization of the cervix, a lesion was observed, a biopsy would be the typical next step, according to Dr. Morales. The caveat to his opinion in the ability to perform that biopsy would depend upon the patient that was being taken care of and the sense that the physician had about the patient's expectations of what should be done and not done. It is assumed that Dr. Morales believed that the level of relationship between Respondent and Patient A.G. would allow the performance of the LEEP conization biopsy. Dr. Morales believes that the attempt to be 100 percent accurate in the identification of patients preoperatively is an aspirational goal, not a requirement. For him all persons concerned have the responsibility for taking care of the patient. Having considered the opinions expressed by the experts, the ultimate facts to be determined must be based upon the realization that Respondent proceeded to perform the LEEP conization biopsy on patient A.G. without advance written consent, that Respondent believed that he was confronting the case of patient N.C., and that the performance of the LEEP conization on Patient A.G. was not in its timing and justification part of the diagnostic laparoscopy scheduled to be performed on Patient A.G. The earlier effort by Respondent to identify his patient in the holding area was sufficient for that stage of the process. Respondent acted in the customary manner in relying upon his knowledge that Patient N.C. was to be the third patient based upon the schedule. It was not unexpected that Respondent would rely upon the surgical staff in orally confirming the patient identity and the procedure to be performed when entering the operating room for the scheduled third procedure. This identification was further confirmed by the presence of the chart for Patient N.C. Respondent's failure to take further steps to physically identify the patient by looking at her arm bracelet, by looking at her face, or in some other manner recognizing the mistake that had been made by others in readying Patient A.G., and not Patient N.C. for surgery could be forgiven if there were no consequences, but there were. Although Respondent should not be the absolute guarantor in the identification of the patient, what he did in the operating room was not enough, when the result is that Respondent performed the LEEP conization that was not consented to in advance, and performed believing that the patient was N.C., the patient for whom the procedure was intended, and was not in response to an emergency regardless of patient identity. As a result, Respondent failed to meet the standard of care for reasonably prudent similar physicians under acceptable similar conditions and circumstances in his actions. In mitigation, the outcome was not harmful to the patient. Moreover, other health care professionals were in great measure responsible for the failure to properly identify the patient.

Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That a final order be entered finding Respondent in violation of Section 458.331(1)(t), Florida Statutes, and imposing a $1,000.00 administrative fine and costs of investigation and prosecution. DONE AND ENTERED this 8th day of November, 2002, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS 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 8th day of November, 2002. COPIES FURNISHED: Robert C. Byerts, Esquire Kim Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 David W. Moye, Esquire Linda Loomis Shelley, Esquire Fowler, White, Boggs and Banker, P.A. Post Office Box 11240 Tallahassee, Florida 32302 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701

Florida Laws (6) 120.569120.5720.43456.072458.331464.012
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REBECCA CRANE vs AGENCY FOR HEALTH CARE ADMINISTRATION, 00-000775 (2000)
Division of Administrative Hearings, Florida Filed:Orlando, Florida Feb. 18, 2000 Number: 00-000775 Latest Update: Mar. 06, 2001

The Issue Whether Petitioner's request for authorization for the autologous chondrocyte implantation procedure should be approved pursuant to worker's compensation laws and rules.

Findings Of Fact Petitioner's Injury At all times, the Petitioner has been employed as a Ladies Wear Department Manager for K-Mart Corporation. On July 21, 1998, Petitioner, while in the course and scope of her employment, was injured when she fell on a metal ladder as she attempted to hang clothes on a rail. Her left knee struck a metal bar on the second step of the ladder, causing immediate pain. On August 26, 1998, Petitioner consulted Dr. Jeffery Friedman, M.D., an orthopedic surgeon, who specializes in knee and shoulder surgery. Dr. Friedman was recognized as an expert in the field of orthopedic surgery. On or about September 4, 1998, Petitioner underwent arthroscopic surgery performed by Dr. Friedman to remove a loose body from the knee. Dr. Friedman found grade III chondromalacia and debrided the area using an arthroscopic shaver. He also found loose articular cartilage at the patella. Dr. Friedman's records describe the area of grade III chondromalacia as "fairly large" and involving " the apex of the patella." However, neither the size nor the shape of the injury is disclosed. Dr. Friedman also debrided flake of articular cartilage from the tibial plateau and removed a calcific loose body from the posteromedial compartment. His post-operative diagnosis was left knee loose body, chrondromalacia, and intracruciate ligament strain. Petitioner returned to work with K-Mart after the arthroscopic surgery, and was placed on light duty. While performing her duties, Petitioner is required to stand most of the time, and is unable to sit. Prior to her injury, Petitioner worked 40 hours per week. After her injury, due to her physical limitations resulting from the accident, Petitioner is only able to work 24 hours per week. Petitioner's pain limits her ability to work 40 hours per week. Petitioner cannot put her full weight down on the left knee while going up steps or a ladder or it causes sharp shooting pains. In addition, continuous walking results in continuous aching pain. The reduction in Petitioner's work hours was due to her injury. Petitioner is now unable to perform all of the duties that were required of her before the injury. Dr. Friedman found Petitioner to have reached maximum medical improvement in December 1998. In early 1999, Petitioner sought treatment for continued pain. An MRI was performed on or about March 5, 1999, which suggested a small defect in the articular cartilage, thinning of the patellar cartilage, and narrowing of the medical femoral tibial joint consistent with the early stages of osteoarthritis. In June, 1999, Petitioner underwent steroid injections for continued pain. In September, 1999, Petitioner returned to Dr, Friedman because of continued pain. Dr. Friedman reviewed a video tape that he had made of the arthroscopic surgery and fount that the Petitioner had a fairly large chondral defect of the patella. Dr. Friedman determined that Petitioner was a candidate for ACI, also known as the Genzyme Carticel Procedure (Genzyme Procedure). Dr. Friedman believed that the ACI procedure would benefit Petitioner by providing long-term symptomatic relief with joint pain and mechanical disturbances and improved joint motion function, eliminating the complaints of grinding and catching, and furthering the goal of returning the patient to regular and even strenuous activity. Petitioner then requested authorization for the ACI procedure. The Employer/Carrier denied the request and referred it to the Agency for Health Care Administration for review in accordance with Florida law. The Agency consulted with the University of Florida Faculty Practice Group, and Dr. B. Hudson Berrey, Chair of the Department of Orthopaedics and Rehabilitation, rendered an opinion that the procedure is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. Dr. Berrey further opined that there was not reliable evidence that ACI would provide significant benefit to the recovery and well-being of the injured employee within the meaning of Rule 59B-11.004(3), Florida Administrative Code. The documents and information forwarded to Dr. Berrey by Respondent included Petitioner's medical records provided by Intervenor, K-Mart carrier. Dr. Berrey did not review any actual MRI films, did not review any films taken at the time of the arthroscopic procedure, and in fact only reviewed certain documentation that was supplied to him by the agency. Petitioner was denied her right to present information to Dr. Berrey prior to his forming his opinion for the agency. This was a violation of Rule 59B-11.003, Florida Administrative Code. The agency rendered a decision based upon Dr. Berrey's opinion, declining to order the Employer/Carrier to provide ACI to Petitioner. Autologous Chondrocyte Implantation The ACI procedure was initially developed in Sweden by Dr. Lars Peterson. ACI is a surgical procedure whereby a sample of cartilage is harvested from another area of the joint. The harvesting of the cartilage is performed during an arthroscopic surgical operation. The sample is sent to Boston to the laboratory of Genzyme Tissue Repair, Inc. ("Genzyme"), the owner of the process. Genzyme uses its proprietary process to culture the cells into an estimated 12 million chondrocytes over a period of approximately two months. Genzyme then returns the cultured chondrocytes to the surgeon. The surgeon then performs an open surgical operation. The surgeon creates a periosteal flap. In addition, the injury is debrided and the chondrocytes are implanted on the wounded cartilage and covered with the periosteal flap. The ACI procedure thus requires two surgical operations, one arthroscopic procedure and one open procedure. The claimed benefit of ACI is that the cartilage that is generated and implanted onto the knee will be hyaline cartilage or hyaline-like cartilage rather than fibrocartilage. Hyaline cartilage is composed both of the cartilage cells of an extra-cellular matrix. It has greater ability than fibrocartilage to withstand compression and shearing forces. ACI has been shown to produce "hyaline-like" cartilage in some patients. However, it does not reproduce the extra- cellular matrix in which the chondrocytes are found in naturally occurring hyaline cartilage. Alternative Treatments Other available treatments for a defect in articular cartilage of the knees include abrasion chondroplasty, arthroscopic microfracture, and arthroscopic drilling. Many patients get relief with one or more of these alternative procedures and do not need another operation. In addition, a surgical procedure to elevate the tibial tubercle and remove some of the weight from the patella might also alleviate the Petitioner's pain and improve her functioning. Dr. Friedman performed an abrasion chondroplasty during the arthroscopic surgery of September 4, 1998. Dr. Friedman did not offer Petitioner either the microfracture or the drilling procedures. Dr. Friedman had considered performing a tibial tubercle elevation but has not recommended that the Petitioner undergo that procedure either before the ACI is approved or independently of the ACI. Dr. Friedman views the primary purpose of this procedure as assuring the best possible results from the ACI. Dr. Friedman indicated there were no appropriate alternative medical procedures, other then the ACI procedure, available for Petitioner's injury. Dr. Friedman opined that the only viable option of putting back normal articular cartilage underneath the kneecap would be with the ACI procedure. In this opinion, the alternative procedures are not appropriate for and would not benefit Petitioner, as they were merely temporary procedures. Moreover, he emphatically stated that the ACI procedure is the procedure which is appropriate for an would benefit Petitioner. The Evidence That ACI Remains Investigative The Agency for Health Care Administration has not promulgated, endorsed, or approved any particular treatment for injuries to the articular cartilage of the knee in accordance with Sections 440.13(15) or 408.02, Florida Statutes; therefore, there was no Agency-approved protocol for Dr. Berrey to consider in rendering his opinion. Dr. Berrey testified that he could find no articles or publications describing controlled studies in which the effectiveness of ACI compared to any other procedure. Dr. Berrey further testified that he could find no articles about the ACI procedure in peer-reviewed journals in which the authors used objective measures of outcome which compared the patients' condition before and after treatment. The use of blinded or controlled studies is important so that possible confounding factors or variables can be controlled or accounted for and the results measured objectively. Dr. Berrey found that the publications cited by the proponents of the procedure discussed research which was funded by Genzyme, the owner of the process by which the chondrocytes were cultured. The funding of the research by the owner of the process was an additional factor in his determination that the evidence supporting the efficacy of the procedure was not reliable. The Cartilage Repair Registry and the results reported therein do not constitute reliable evidence of the benefits of ACI when compared to other available procedures for two reasons. First, the potentially confounding variables are neither controlled nor accounted for. Second, each surgeon evaluates his or her own work, so that there is no objective, independent measurement or assessment of the condition of each patient before and after surgery. Although the premise on which ACI is based is that the patient's implant will consist of hyaline cartilage rather than fibrocartilage, the available data does not indicate that the results are comprised only, or even primarily, of genuine hyaline cartilage. Rather, the evidence is that some patients develop "hyaline-like" cartilage, or cartilage composed partly of hyaline tissue. It cannot be determined whether hyaline or hyaline- like cartilage has filled a patient's defect without performing a biopsy and a histological evaluation of the tissue. The published reports described in the testimony contain discussions of post-surgical histological performed on very small numbers of patients. The published reports concerning the use of ACI to treat defects of the patella show that the results are not as favorable as those claimed for treatment of the femoral condyle. After the proponents of the procedure began to perform other procedures with the ACI to assure that any defects in the alignment of the patella are repaired, improved results were reported. Dr, Friedman testified about the published results of histological evaluations of 37 patients. Of those, seven underwent ACI to treat defects of the patella. Only one of the seven showed the development of hyaline-like tissue. Further, only two of the seven patella patients reported surgical results classified as good or better. Dr. Friedman opined that the histological data resulting from treatment of defects of the patella had improved since the study described in the preceding paragraph. However, he could not give any reference to the basis for his opinion. Dr. Friedman further testified that the more recent articles discussed the results of patients who had been followed from nine to 15 years. However, the articles and presentations from 1997 to 2000 report on follow-up of the first hundred patients between two and nine years after their surgery. Dr. Billings testified that Dr. Peterson's presentation discussed follow-ups of ACI patients occurring as long as 15 years after surgery. Yet, the March 2000 presentation to the American Academy of Orthopedic Surgeons focused on 40 patients who had been evaluated three or more years after their surgery. The FDA granted an accelerated approval of the Carticel product in 1997. The original accelerated FDA approval was granted for defects of the femoral condyle, the trochlear groove, and the patella. The terms of the approval require that controlled studies be conducted which compare the procedure to other procedures available for the treatment of focal chondral defects, specifically, microfracture and the creation of a periosteal flap without the injection of the cultured chondrocytes. None of the expert witnesses had found in their literature search any published reports of the progress of the controlled studies required under the terms of the accelerated FDA approval. In February, 2000, the FDA approval was modified. Genzyme is no longer permitted to market the ACI procedure or its Carticel product for treatment of defects to the patella. The requirements of Rule 59B-11.004, Florida Administrative Code, differ significantly from those of the accelerated FDA approval process, so that the granting of accelerated approval does not determine the answer to the question whether a treatment is investigative under that rule. The FDA's inquiry addresses the issues of safety and efficacy. However, the accelerated FDA approval process does not address the issues of whether a particular product is more effective than currently existing treatments or is equally cost-effective. Based upon all the evidence, the performance of the ACI procedure on the defects located in the patella is investigative within the meaning of Rule 59B-11.002(5), Florida Administrative Code. The Probability That ACI Would be of Significant Benefit in Returning Petitioner to Work Both of Petitioner's expert witnesses testified that if she does not undergo ACI, it is likely that she will need a total knee replacement. However, neither witness testified that Petitioner currently requires a total knee replacement. No testimony was presented as to when Petitioner might require a total knee replacement. Despite the testimony that ACI has been studied for 20 years, the published reports follow patients only for nine years after surgery. From the current state of the research, it is not possible to conclude that patients who undergo ACI avoid the need for subsequent surgery in ten or more years. The published studies of the results of ACI going out nine years from the date of surgery do not state the number of procedures performed on the patella. No witnesses testified regarding any published studies of the effectiveness of ACI that addressed the extent to which patients had been able to return to work as a result of the procedure. There is insufficient evidence from which to conclude that the ACI is more likely to enable the Petitioner to return to her duties that other available procedures. The Likelihood That the Benefits of ACI Would Outweigh the Risks and the Costs The testimony compared the cost and benefit of ACI with chondroplasty, microfracture or drilling, and, to some extent, a Macquet procedure or tibial tubercle elevation. Each of the other procedures requires only one surgical operation. ACI requires an arthroscopic surgical procedure to harvest cartilage, culturing of the chondrocytes at the Genzyme laboratory in Boston, and followed by an open surgical procedure to create a periosteal flap and to implant the chondrocytes. Petitioner's expert testified that the cost of culturing the chondrocytes alone was between $8,000 and $10,000, in addition to the two surgical procedures. Petitioner's expert compared the cost of ACI to that of a total knee replacement. However, that comparison is not appropriate under the rule because there is no evidence that Petitioner currently needs a knee replacement or that a knee replacement is the treatment generally used to treat her current condition. The cost of the abrasion chondroplasty, the microfracture or drilling procedure would approximate the cost of the first stage of ACI, approximately $2,300. Dr. Billings testified that the cost of the second stage of ACI was greater than that of the first stage. The second stage is an open surgical operation rather than an arthroscopic one. The total cost of the ACI procedure, including therapy, is probably close to the $30,000 required for a total knee replacement, including the therapy required for the total knee replacement. Dr. Berrey testified that published reports of the cost of ACI are as high as $37,000. The ACI requires extensive physical therapy; Petitioner presented no evidence as to the extent to which the cost of this aspect of treatment was included in the total cost of ACI. ACI has been established to be safe, so that the benefits of the procedure outweigh the risks. However, there is insufficient evidence from which to conclude that the benefits of ACI outweigh the additional costs.

Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order denying approval of the autologous chondrocyte implantation for Petitioner Rebecca Crane. DONE AND ENTERED this 27th day of November, 2000, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 27th day of November, 2000. COPIES FURNISHED: Jeffrey J. Bordulis, Esquire 570 Crown Oak Centre Drive Longwood, Florida 32750 Lisa J. Hurley, Esquire Pyle, Jones, Hurley & Hand, P.A. 1069 West Morse Boulevard Winter Park, Florida 32789 Michelle L. Oxman, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308

Florida Laws (3) 120.569120.57440.13
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GAYLE STEVENSON, M.D. vs JACKSON MEMORIAL HOSPITAL, 02-000240 (2002)
Division of Administrative Hearings, Florida Filed:Miami, Florida Jan. 17, 2002 Number: 02-000240 Latest Update: Dec. 26, 2002

The Issue Whether Respondent committed an unlawful employment practice against Petitioner in violation of Section 760.10 et. seq., Florida Statutes, as set forth in Petitioner's Petition for Relief filed with the Florida Commission on Human Relations (FCHR) and, if so, the penalties that should be imposed.

Findings Of Fact Petitioner is a female African-American who has completed medical school. On March 19, 1997, Petitioner completed an "Application for Residency," seeking to participate in Respondent's clinical anesthesiology residency program. That program is operated in conjunction with the Public Health Trust. Applicants selected to participate in the residency program become employees of Respondent. The terms and conditions of employment are subject to the policies of both Respondent and the Public Health Trust. Petitioner's application to participate in the residency program related that she had completed an internship at University of Maryland/Harbor Hospital (Harbor) and two years of anesthesiology residency at King/Drew University, Los Angles (King). Petitioner signed the application on March 19, 1997. On April 30, 1997, Petitioner submitted an "Application for Graduate Medical Education at the Jackson Memorial Medical Center" that required her to "list chronologically your activities from time of graduation from Medical School to present. Specify type of post graduate training if any." Petitioner listed the internship at Harbor and the residency at King. She signed the application under the declaration: "I hereby declare that I have examined this application; and to the best of my knowledge and belief, it is true, correct, and complete." Petitioner was accepted into Respondent's clinical anesthesiology residency program based, in part, on the information reflected in the foregoing applications. That acceptance created an employee/employer relationship between Petitioner and Respondent. On July 17, 1997, Petitioner submitted a completed "Personnel Form" to Respondent. The Personnel Form required her to disclose all her activities since her completion of medical school. On that form Petitioner listed her previous internship at Harbor and her previous residency training at King. She verified it was correct to the best of her knowledge and signed the form. At the times pertinent to this proceeding, Dr. Brian Craythorne was a Professor of Medicine at the University of Miami and the Chairman of Respondent's Department of Anesthesiology. Dr. Craythorne had supervisory responsibility for Petitioner and was instrumental in selecting her to participate in the residency program. In April 1998, Dr. Craythorne received routine information from the American Board of Anesthesiology (ABA) setting forth the number of hours of training from other anesthesiology residency programs for which each resident participating in Respondent's residency program had received credit. The information from the ABA also set forth the number of hours of training for which each resident had received no credit. From that information, Dr. Craythorne learned that Petitioner had a total of 39 hours of residency training in anesthesiology from other programs for which she had received no credit. Three of the 39 hours of training for which she had no training were at King, which was reflected on her application and related paperwork. The training at King is not an issue in this proceeding. The additional 36 hours of residency training for which she received no credit was from Howard Hospital. 1/ The program at Howard, which was equivalent to a three-year program, was not reflected on any application or related document Petitioner submitted to Respondent before April 1998. Petitioner's failure to disclose her participation in the residency program at Howard was intentional. Petitioner's failure to disclose her participation in the residency program at Howard violated the clear policies of both Respondent and the Public Health Trust that require applications and related documents to be truthful, correct, and complete. Dr. Craythorne confronted Petitioner about the foregoing omissions in her applications and associated paperwork. In response, Petitioner submitted a letter dated May 27, 1998, in which she tried to explain why she did not obtain credit at Howard and why she had not divulged that information to Respondent. Petitioner asserted that she had sued Howard and had subsequently settled the litigation with instructions from her attorney that she could not discuss the litigation. 2/ Petitioner's letter of May 27, 1998, was not satisfactory to Dr. Craythorne. On June 3, 1998, Dr. Craythorne issued to Petitioner a "Disciplinary Action Report" (DAR) advising he was recommending that Petitioner be dismissed from the residency program (thereby terminating her employment with Respondent). The grounds for the action were her violation of Respondent's policies by making a false statement or statements on her application for employment and related documents and her violation of Public Health Trust Policy #305 pertaining to falsifying records or any other record of the Trust. Referencing Respondent's Department of Anesthesiology, the DAR also contained the following: Our department's recruiting and hiring practices . . . includes a policy/practice not to accept residents [sic] who have had more than one prior anesthesia residency experience for the clinical anesthesia years 1 through 3. [3/]] On June 29, 1998, Dr. Craythorne wrote a letter to Petitioner terminating her employment on the grounds set forth in the DAR. The termination letter advised Petitioner that she could request the Senior Vice President for Medical Affairs (Dr. Gerard A. Kaiser) to review the decision to terminate her participation. The letter also advised Petitioner that "[u]nless the Senior Vice President rescinds the proposed action, it will become effective following his review and decision." On July 21, 1998, Dr. Kaiser advised Petitioner that he had reviewed the facts surrounding her termination and agreed with the termination decision. Consistent with her rights pursuant to the applicable collective bargaining agreement, Petitioner requested and received a hearing before the Peer Review Committee, which was composed of other participants in the anesthesiology residency program. On December 1, 1998, the Peer Review Committee issued its report upholding Petitioner's termination for the reasons cited by Dr. Craythorne. On December 23, 1998, Ira C. Clark, president of the Public Health Trust, advised Petitioner that he had upheld her dismissal based on his review of the Peer Review Committee's findings and recommendation. Petitioner thereafter filed a grievance pursuant to her collective bargaining rights. On October 21, 1999, an evidentiary hearing was conducted before an arbitrator. On November 1, 1999, the arbitrator entered his Opinion and Award upholding Petitioner's termination of employment. Petitioner thereafter filed a complaint of discrimination with the FCHR on or about March 27, 2000. The gravamen of the complaint was that Respondent fired her in retaliation for her complaint to Dr. Craythorne that another resident had made a derogatory racial comment towards her. On December 10, 2001, the FCHR entered a determination of "no cause," determining that there was no cause to believe that an unlawful employment practice had occurred. On January 14, 2002, Petitioner filed a Petition for Relief from an unlawful employment practice with the FCHR. The Petition alleged the following facts in support of her claim of discrimination: On April 1, 1998, a racial remark was made to me by Dr. Kirsten O'Neal, which was, "we know how lazy you Blacks are." I reported it (the statement) to Dr. Craythorne and Dr. Brindle, as well as in writing (copies are in my file). Dr. Craythorne asked me if I had any witnesses, I said yes. The following month they decided to investigate my application, and terminated me on July 1998 (sic). The Petition described the disputed issues of fact as follows: I was terminated because I did not put on my application that I had worked for Howard Hospital in Washington, D. C. They stated the reason I was terminated is because the ABA (American Board of Anesthesiology) requires that you only attend two programs if you have received credit. I did not receive any credit. Please see the enclosed pamphlet from the ABA at page 9. The Petition set forth the following ultimate facts entitling Petitioner to relief: When JMH terminated me, it was because I made a claim of racial discrimination, which I reported prior to investigation of my application. Had I not complained of racial remarks that was made to me by the above Dr. Kirsten O'Neal, it would not have come up about my application. The evidence established that Petitioner complained to Dr. Craythorne that Dr. O'Neal had made the derogatory, racial remark set forth in the Petition. 4/ There was no evidence to establish a link between the complaint made by Petitioner to Dr. Craythorne pertaining to Dr. O'Neal and the decision to terminate her participation in the residency program. Respondent established that Petitioner was terminated because she failed to adhere to Respondent's and the Public Health Trust's clear policies requiring applications and other employment documents to be truthful, correct, and complete.

Recommendation Based on the foregoing findings of fact and conclusions of Law, it is RECOMMENDED that the Florida Commission on Human Relations enter a final order dismissing the Petition for Relief filed in this case. DONE AND ENTERED this 16th day of August, 2002, in Tallahassee, Leon County, Florida. CLAUDE B. ARRINGTON 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 16th day of August, 2002.

Florida Laws (2) 120.57760.10
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