Findings Of Fact Based upon the evidence adduced at hearing, and the record as a whole, the following Findings of Fact are made: The Agency is a state government licensing and regulatory agency. Respondent is now, and has been since July 1, 1980, an endocrinologist licensed to practice medicine in the State of Florida. His license number is ME 0036628. At no time during the period that he has been licensed to practice medicine in the State of Florida has he had any disciplinary action taken against him by the Board of Medicine. Respondent is board certified in internal medicine, nuclear medicine and endocrinology and metabolism. At all times material to the instant case, Respondent was in private practice in Palm Beach County, Florida. One of his patients was L.Y., who, at the time of her first visit, was 75 years of age. L.Y. had been treated by at least two other endocrinologists, Rachmel Cherner, M.D., and William Abelove, M.D., for a thyroid abnormality before being referred to Respondent for treatment. A physical examination of L.Y. conducted during a visit to Dr. Cherner's office in Pennsylvania in early September of 1984, revealed that there was "a firm three centimeter nodule in the inferior pol[e] of the right lobe" of L.Y.'s thyroid gland and that the "inferior margin of the gland apparently dip[ped] substernal." 2/ Dr. Cherner ordered a thyroid uptake and scan. The uptake and scan were performed on September 5, 1984. Dr. Cherner received the following report of the results of the uptake and scan: Thyroid studies were performed following the oral administration of 100 uCi. of Iodine 123 on 9/5/84. The thyroid uptake is 15 percent at 4 hours and 41 percent at 24 hours. The 24 hour value is in the high/normal to slightly elevated range for this age group. Visualization of the thyroid reveals the gland to be prominent due to enlargement of the right lobe. There is a relatively homogeneous distri- bution of nuclide in a normal size left lobe. The right lobe is slightly enlarged and bulboused. There is marked nuclide irregularity laterally suggesting one or more "cold" nodules. 3/ There is slightly increased activity noted inferiorly in the right lobe but this finding is less impressive. In February of 1985, L.Y. was seen by Dr. Abelove in Dr. Abelove's office in Coral Gables, Florida. Dr. Abelove's notes relating to the visit read as follows: [L.Y.] is a 71 year old female, resident of Delray Beach, Florida, referred by Dr. Cherner in Jenkintown for thyroid follow-up. [L.Y.] was found by Dr. Cherner to have enlargement of the right lobe of the thyroid gland. On September 5, 1984, he had a thyroid uptake and scan done at Abington Memorial Hospital. Uptake at four hours was 15 percent and at twenty-four hours was 41 percent. Thyroid scan disclosed the right lobe to be enlarged and bulboused with marked [n]uclide irregularity suggesting one or more cold nodules. [L.Y.] clinically is euthyroid. She has been on Hydrodiuril 50 mg. once daily in the AM and Valium 5 mg. prn for some time. Weight is stable. Physical examination disclosed slight stare but no significant tremors. Skin was dry. Palms were warm and dry. The right lobe of the thyroid gland was irregularly enlarged to about two and one-half to three times normal size. Left lobe was normal. The gland was not tender. Heart and lungs were okay. Reflexes were normal. I think [L.Y.] has a nodular goiter involving the right lobe of her thyroid gland. The uptake of radioactive iodine was marginal at 41 percent and she does have a slight stare but clinically no other findings compatible with hyperthyroidism. Her goiter has not increased in size and she has no hoarseness or dysphagia. Dr. Cherner felt that observation was indicated and he planned to repeat her thyroid scan. I will be in contact with him and advise her accordingly. Pursuant to Dr. Abelove's orders, an uptake and scan of L.Y.'s thyroid were performed on April 26, 1985, the results of which were reported as follows: The scan shows enlarged nodule over the base of the right lobe of the thyroid gland. This nodule [is] hypofunctioning 4/ when compared with the adjacent right and left lobes. The uptake values at 4 and 24 hours are 10.5 percent . . . and 23.1 percent . . . respectively. These are within euthyroid range. OPINION: Thyroid uptake and scan Hypofunctioning nodule right thyroid lobe. Thyroid uptake within euthyroid range. L.Y. next visited Dr. Abelove on November 14, 1985. Dr. Abelove's notes relating to this visit read as follows: [L.Y.] returns for a follow-up visit. In late April of this year, she had a thyroid uptake and scan done at the Bethesda Memorial Hospital. Thyroid function was normal The scan disclosed a hypofunctioning nodule. [L.Y.] remains asymptomatic. She's aware of the presence of the nodule and on physical examination it is unchanged. It involves the right lobe only and is somewhat irregular with the lobe being 2 1/2 times normal size. She denies any dysphagia or hoarseness. Weight is stable. Clinically, she is euthyroid. She remains on Hydrodiuril 50 mg once daily in the a.m. and Valium 5 prn. MHP ordered for today. My recommendation is a trial on thyroid suppression using Synthroid 0.05 mg once daily. 5/ Will call the results of the MHP to her tomorrow. I've asked [L.Y.] to call me in about 2 months and let me know if she notices any change on Synthroid 0.05 daily. Dr. Abelove next saw Respondent on May 21, 1987. His notes relating to this visit read as follows: [L.Y.] returns for a follow-up visit, having been seen last in November of 1985. She remains on Synthroid 0.05 mg daily. Clinically, she is euthyroid. Examination of her neck shows little change. The right lobe is irregularly enlarged and approximately 2 1/2 times normal size. The left lobe is not significantly palpable. Heart and lungs are okay. [L.Y.] is also on Hydrodiuril 50 mg once daily and calcium. I suggested that she have a complete work up while she is here. MHP, EKG, chest x-rays and dual photon absorption densi- tometry were ordered. We will discuss the findings with her when everything is completed in several days. In the meantime, she is to increase Synthroid to 0.1 daily. She was given Rxs for Hydrodiuril 50 mg to be taken once daily. We will speak to her next week. She finds it extremely difficult to drive here from Delray Beach as it takes her 2 hours. I am going to give her the name of an endocrinologist in Boca whom she can see for follow-up. Respondent was the "endocrinologist in Boca" to whom Dr. Abelove referred L.Y. 6/ L.Y. first presented to Respondent on November 22, 1988. At the time of the visit, Respondent did not have any of L.Y.'s prior medical records. At the outset of the visit, Respondent took a history from L.Y. 7/ L.Y. told Respondent that she had a thyroid "nodule" that Drs. Cherner and Abelove had monitored for the past five years and that she had been advised that there was a "low chance" that the "nodule" was malignant. 8/ Respondent then conducted a physical examination of L.Y. As part of the examination, he palpated L.Y.'s thyroid and noted a "prominent nodule 9/ in the lower pole of the right lobe." Based upon the history provided by L.Y. and his physical examination of her, Respondent reasonably believed that she had a multinodular goiter. Multinodular goiters are not uncommon in elderly persons. Unless they are characterized by a dominant mass, they generally have a low potential for malignancy. Accordingly, they are not always biopsied. Multinodular goiters that are not biopsied, however, should be carefully monitored, with particular attention paid to any changes in their size or the pattern of their growth that may be indicative of the presence of a carcinoma. Accurate measurements are necessary to determine if such changes have taken place. It is impossible to obtain such accurate measurements simply by physical examination where, as was situation in L.Y.'s case, a portion of the thyroid lies beneath the sternum. In such instances, a CAT scan or ultrasound must be performed to get the needed information. Consistent with the approach Drs. Cherner and Abelove had taken, Respondent did not perform or order a "fine-needle" biopsy 10/ or any other type of biopsy to ascertain whether L.Y. had thyroid cancer. Instead, he instructed L.Y. to continue to take thyroid suppression medication and to return to his office for reevaluation on at least an annual basis. At no time during, or in conjunction with, this initial visit did Respondent order a CAT scan or ultrasound or otherwise attempt to obtain any measurements of L.Y.'s thyroid. On October 24, 1989, L.Y. returned to Respondent's office for a follow-up visit. Respondent examined L.Y., but did not order a CAT scan or ultrasound or otherwise attempt to obtain any measurements of L.Y.'s thyroid. He determined that L.Y.'s "right prominent thyroid nodule [was] unchanged from last year," notwithstanding that he did not have the benefit of any measurements upon which to base such a conclusion. Respondent did not discover anything during L.Y.'s October 24, 1989, visit to cause him to perform or order a biopsy or to otherwise alter his course of care and treatment of L.Y. He continued L.Y. on thyroid suppression medication and asked her to return to his office for a follow-up visit in approximately a year. L.Y. made such a visit on November 12, 1990. Once again, Respondent examined L.Y., but failed to order a CAT scan or ultrasound or otherwise attempt to obtain any measurements of L.Y.'s thyroid. As he had done during L.Y.'s previous visit the year before, Respondent determined that the "thyroid nodule in her right lobe was unchanged," although he did not possess any measurements that would support such conclusion. Respondent did not discover anything during L.Y.'s November 12, 1990, visit to cause him to perform or order a biopsy. In light of the results of recent blood tests that L.Y. had taken, Respondent adjusted the dosage of L.Y.'s thyroid suppression medication. He made no other changes to her treatment regimen as a result of her November 12, 1990, visit. L.Y. made an unscheduled visit to Respondent's office on October 4, 1991, complaining of pain and inflammation near the medial aspect of her clavicle. Examination of her neck revealed marked swelling, which led Respondent to suspect that L.Y. had sustained a clavicular fracture. Respondent referred L.Y. to the emergency room of Delray Community Hospital for x-rays and treatment. L.Y. went to the emergency room. X-rays were taken. In addition, a CAT scan, which was ordered by the emergency room physician, was performed. The radiologist who read the CAT scan stated the following in a written report of his findings: There is a 7 mm [sic] well circumscribed inhomogeneous mass 11/ that replaces the right lobe of the thyroid. This is charac- terized by multifocal areas of low attenuation. 12/ There is marked left sided displacement of the trachea. The left lobe of the gland is unremarkable. CONCLUSIONS: 7 cm 13 inhomogeneous right thyroid mass. This may represent goiter with degenerated adenomas. But carcinoma cannot be excluded. 14/ The radiologist's report supported Respondent's view that L.Y. had a multinodular goiter and it did not contain any information that caused Respondent to suspect that L.Y. had thyroid cancer. Respondent, however, was unable to evaluate the significance of the finding that the "thyroid mass" described in the report was now "7 cm" inasmuch as he did not have any prior measurements of the full extent of this "mass" and therefore could not ascertain whether this "7 cm" measurement represented a significant increase in the size of the "mass." After consulting with the emergency room physician who had seen L.Y., Respondent prescribed Voltaren, an anti-inflammatory medication, for L.Y. and instructed her to return for a follow-up office visit in ten days. No biopsy was performed or ordered. L.Y. returned to Respondent's office on October 14, 1991, and was examined by Respondent. The swelling that Respondent had noted during L.Y.'s October 4, 1991, visit had "disappeared." The examination further revealed that L.Y.'s thyroid was "still enlarged." Respondent continued to believe that L.Y.'s enlarged thyroid was nothing more than a multinodular goiter with a low potential for malignancy and that it therefore did not need to be biopsied. Accordingly, no biopsy was performed or ordered. L.Y.'s next visit to Respondent's office was on September 4, 1992. During this visit, L.Y. reported that she felt well and that she was "having no further trouble with her clavicle." At the time of the visit, her weight was 121 pounds, seven and a half pounds less than she weighed on her last visit and thirteen pounds less than she weighed on her initial visit to the office on November 22, 1988. L.Y. attributed her weight loss to her having "changed her diet and markedly cut down on her intake of fat," a reasonable explanation that Respondent accepted. Respondent's examination of L.Y. revealed that she still had a "huge right thyroid lobe," which, in Respondent's opinion, had not changed since the last time he had seen her. Respondent, however, did not order a CAT scan or ultrasound or otherwise attempt to obtain the current measurements of this "huge right thyroid lobe" to see if it had grown since the October 4, 1991, CAT scan. L.Y. next visited Respondent's office on October 2, 1992. This was an unscheduled visit. Upon presenting at the office, L.Y. indicated that she was very concerned about her "thyroid nodule" because she felt that it was changing. Respondent's examination of L.Y.'s neck revealed a "huge thyroid mass." Respondent believed the "mass" to be "unchanged from prior examinations." Nonetheless, given L.Y.'s concerns, Respondent performed a "fine needle" biopsy "to determine the histology of this lesion." In waiting almost four years from the time of L.Y.'s initial visit to his office to perform such a biopsy, without having ordered, during this period of time, the CAT scans or ultrasounds that were necessary to properly monitor L.Y.'s multinodular goiter, Respondent acted in a manner that was inconsistent with what a reasonably prudent endocrinologist would have recognized as being acceptable and appropriate under the circumstances. The aspirate material collected from the biopsy was sent to a pathologist, Albert Cohen, M.D., for analysis. Dr. Cohen analyzed the biopsied aspirate and made the following findings, which he set forth in a written report: Multiple slides and fluid from cell block from thyroid aspiration biopsy showing markedly cellular aspirate with clusters of thyroid follicular cells some of these in papillary configuration and others scattered in a loose fashion. In addition there are large numbers of giant cells with many of the cells in the cell block showing mitotic activity. The differential diagnosis in this case is of a poorly differentiated neoplasm with giant cell features, including medullary, papillary or undifferentiated carcinoma. NOTE: Due to the marked cellularity and the giant cell formation of this aspirate, surgical excision is strongly recommended. The presence of giant cells in the biopsied aspirate indicated that L.Y. had an anaplastic carcinoma, which is an extremely aggressive and fast growing form of cancer. 15/ The prognosis for patients with an anaplastic carcinoma of the thyroid is very poor. The average life expectancy of such patients is approximately seven months from the time of diagnosis. L.Y. returned to Respondent's office on October 8, 1992. Respondent informed her of the results of the biopsy and suggested that she undergo a thyroidectomy. L.Y. indicated that she wanted to discuss the matter with her family before deciding whether to have the procedure performed in Florida or New York. In February of 1993, L.Y. died as a result of a metastatic carcinoma of the thyroid.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby recommended that the Board of Medicine enter a final order finding Respondent guilty of the violation of subsection (1)(t) of Section 458.331, Florida Statutes, alleged in the Administrative Complaint, and disciplining him for having committed this violation by fining him $2,500.00 and placing him on probation for a period of two years, subject to those terms and conditions the Board deems appropriate. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 16th day of June, 1995. 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 of Administrative Hearings this 16th day of June, 1995.
The Issue Whether the Petitioner committed the violations alleged in the Administrative Complaint dated September 10, 2004, as amended by Order entered January 11, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: Parties The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. Dr. Byrd is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 43323, and he is Board-certified in Family Practice. At the times material to this proceeding, Dr. Byrd conducted an office practice and saw approximately 20 patients each day, including those who had an appointment and those who walked in without an appointment. In addition to his private practice, Dr. Byrd was, at the times material to this proceeding, a full-time physician for the Brevard County Department of Corrections and was responsible for providing medical care for all prisoners in that system. Facts underlying charges in Administrative Complaint Patient J.S. was a patient of Dr. Byrd's from approximately 1999 until June 2001. Dr. Byrd treated Patient J.S. during that period primarily for general medical issues. Patient J.S.'s last visit to Dr. Byrd's office was June 11, 2001. The office visits material to this proceeding occurred on December 27, 2000; January 29, 2001; and June 11, 2001. Beginning when she was approximately 20-to-21 years of age, Patient J.S. routinely performed breast self-examinations once or twice a month. She performed a self-examination a few days before Christmas 2000, while she was visiting in New Jersey, and believed she felt a lump in her right breast. She drove home the day after Christmas and telephoned Dr. Byrd's office. She told the person she spoke with that she had found a lump in her breast. The record of Patient J.S.'s December 27, 2000, contact with Dr. Byrd's office was inserted into a form that had been completed for an office visit on November 15, 2000. The date "12.27.00" appears approximately mid-way down the page, with a diagonal line drawn underneath. Below the diagonal line was written "Mammo & ultrasound script given[.] Pt feels she may have a lump in Breast." What appear to be the initials "DS" are included beneath the notation, and the handwriting in this notation is that of Dr. Byrd's medical assistant. Dr. Byrd did not examine or speak to Patient J.S. on December 27, 2000, and he relied on the information conveyed to him by his medical assistant in making the decision to write a prescription for Patient J.S. to obtain an ultrasound and a mammogram.2 Dr. Byrd's staff scheduled an appointment with Boston Diagnostic Imaging for Patient J.S., and she had a bilateral film mammogram and an ultrasound of her right breast done on January 3, 2001.3 In the report of the January 3, 2001, bilateral mammography examination, which was dictated January 3, 2001, the radiologist stated: CLINICAL INDICATIONS: Diagnostic mammography. The patient reports a palpable abnormality within the upper outer quadrant of the right breast. This site was marked with triangular marker. FINDINGS: There is a 2 cm asymmetric area of parenchymal density within the upper outer quadrant of the right breast at the approximately 12 o'clock position. This appears fairly distant from the palpable marker. I would recommend additional cone compression views of the right breast at this time. Some small subcentimeter nodular parenchymal densities are scattered through both breasts. No discreet [sic] mass is noted underlying the region of palpable area of clinical concern. Any clinically suspicious palpable abnormality should be aspirated and biopsied. Some benign microcalcifications are noted bilaterally. * * * IMPRESSION: NUMEROUS SUBCENTIMETER NODULAR DENSITIES SCATTERED THROUGHOUT BOTH BREASTS. GIVEN THE MULTIPLICITY OF FINDINGS THESE ARE LIKELY BENIGN. I WOULD RECOMMEND COMPARISON WITH PRIOR MAMMOGRAPHIC STUDY TO DETERMINE STABILITY. ASYMMETRIC 2 CM NODULAR DENSITY LOCATED IN THE 12 O'CLOCK POSITION OF THE RIGHT BREAST POSTERIORLY. I WOULD RECOMMEND CORRELATION WITH PRIOR STUDY OR ADDITIONAL CONE COMPRESSION VIEWS OF THE RIGHT BREAST AT THIS TIME.[4] Dr. Byrd received a copy of this report from Boston Diagnostic Imaging, signed it, and made a notation on the report to "give ptn copy." He assumes that his staff followed his instructions and gave Patient J.S. a copy of the report, but Dr. Byrd does not recall discussing this report with Patient J.S. The report of the January 3, 2001, bilateral mammography examination showed an abnormality in Patient J.S.'s right breast. Dr. Byrd did not, however, order a cone compression view of the right breast or any other diagnostic test as a result of the report. Rather, Dr. Byrd waited for the Boston Diagnostic Imaging radiologist to do a comparison study of the January 3, 2001, mammography results and the results of any prior mammographic study that the radiologist might locate. A second report of the results of the January 3, 2001, examinations was issued by Boston Diagnostic Imaging, the substance of which is a more comprehensive report of the results of the ultrasound examination of Patient J.S.'s right breast.5 In this second report, which was captioned "Bilateral Film Mammography" and dictated on or about January 5, 2001, the radiologist stated: CLINICAL INDICATIONS: Diagnostic breast ultrasound. Palpable lesion in the upper outer quadrant of right breast. FINDINGS: Sonographic evaluation of the 9-12 o'clock position of the right breast was performed at the site of the patient's reported palpable abnormality. At the 10-11 o'clock position in the right breast at the patient's site of reported abnormality, no discrete solid or cystic nodules are noted by ultrasound. There are two small hypoechoic solid nodules noted at the 12 o'clock position of the right breast measuring 8 x 6 mm. in aggregate size. This is nonspecific and may represent small fibroid adenomas. No dominant solid or cystic nodules are noted by ultrasound in the 12 o'clock position of the right breast to correspond to 2 cm. asymmetric parenchyma density noted on the mammography. Recommend additional cone compression views of the right breast at this time.[6] No simple cyst is noted within the upper outer quadrant. IMPRESSION: TWO SMALL SUBCENTIMETER HYPOECHOIC NODULES NOTED AT THE 12 O'CLOCK POSITION IN THE RIGHT BREAST. THIS IS FAIRLY DISTANT FROM THE REGION OF THE PATIENT'S PALPABLE ABNORMALITY. CONSIDER SHORT TERM FOLLOWUP EXAMINATION. CONSIDER FOLLOWUP RIGHT BREAST ULTRASOUND EXAMINATION IN 6 MONTHS TO EVALUATE FOR STABILITY. NO DISCRETE SOLID OR CYSTIC NODULE IS NOTED IN THE 9-11 O'CLOCK [POSITION] IN THE RIGHT BREAST AT THE SITE OF THE PATIENT'S REPORTED PALPABLE ABNORMALITY. ANY CLINICALLY SUSPICIOUS PALPABLE ABNORMALITY SHOULD BE ASPIRATED BY BIOPSY. NO DOMINANT 2 CM. SOLID OR CYSTIC MASS IS NOTED AT THE 12 O'CLOCK POSITION OF THE RIGHT BREAST BY ULTRASOUND. A "Corrected Copy" of the second report contained the following changes: (1) The heading of the corrected report was changed to "RIGHT BREAST ULTRASOUND" examination; (2) the corrected report stated that the technique involved "[u]sing hand-held sonographic technique, breast was scanned"; and (3) the corrected report indicated that the results of the test were compared with the bilateral mammography of January 3, 2001. In all other respects, the "Corrected Copy" of the report was identical to the second report.7 Dr. Byrd did not receive the Corrected Copy of the report of the ultrasound examination of the right breast. He did, however, receive a copy of the second report. Dr. Byrd signed his copy of the second report, and made the following notation: "Patient aware to follow up in six months with ultrasound." Dr. Byrd did not recall speaking with Patient J.S. about the second report, but he assumed from this note that he did speak with her, probably by telephone. Dr. Byrd did not order a cone compression view of Patient J.S.'s right breast, nor did he schedule a short-term follow-up examination. Boston Diagnostic Imaging issued a fourth report, dictated on January 16, 2001, which was entitled an "Addendum" to the report of Patient J.S.'s January 3, 2001, bilateral mammography examination.8 In the Addendum, the radiologist stated: FINDINGS: Study done here 01/03/01 is compared with exam of 03/02/95. Multiple nodular densities were noted on the previous study. Now that old films available, three area[s] of densities, two in left breast and one in the right breast, are significantly larger than they were then. Ultrasound is recommended for further evaluation. The largest of these is on the right [breast] at 12 o'clock and measures 2 cm. Second of these is in the left breast, slightly superior and slightly lateral to the nipple and contains a single calcification. It is probably 1 cm in maximal diameter and these two side by side lesions are seen on the oblique lateral view of left breast superior aspect. One of these twin densities lies medial to the nipple and measures approximately 14 mm while the other of these twin lesions probably lies slightly lateral to the nipple. No skin thickening, nipple retraction, hypervasculature or microcalcifications can be seen. IMPRESSION: 1. BILATERAL BREAST ULTRASOUND IS RECOMMENDED TO EVALUATE A 2 CM LESION AT 12 0'CLOCK IN RIGHT BREAST AND TO EVALUATE THREE NODULAR MASSES IN LEFT BREAST, ALL OF WHICH ARE SLIGHTLY LARGER IN SIZE THAN THEY WERE ON THE 03/02/95 STUDY. ULTRASOUND SHOULD BE DONE AS SOON AS CAN BE SCHEDULED. Dr. Byrd received and reviewed this Addendum report, circled "BILATERAL BREAST ULTRASOUND IS RECOMMENDED," signed and noted "Done" on the first page of the report. Dr. Byrd did not discuss the results of the Addendum report with Patient J.S., did not schedule a follow-up appointment to discuss the report, and did not give Patient J.S. a copy of this report. Dr. Byrd felt that it was sufficient that he intended to order an ultrasound examination of Patient J.S.'s left breast. Patient J.S. called Dr. Byrd's office and scheduled a follow-up appointment for January 29, 2001. She believed that the lump in her right breast was getting bigger. Dr. Byrd saw Patient J.S. during an office visit on January 29, 2001, at which time he did a physical examination and an examination of her breasts. He was unable to find a lump in her right breast, which caused him to question whether Patient J.S. did, in fact, feel a lump. He noted that he found cystic structures in Patient J.S.' left breast. Dr. Byrd also noted in the medical record of the January 29, 2001, office visit the plan to refer Patient J.S. for another ultrasound. Dr. Byrd did not, however, order a bilateral breast ultrasound as the radiologist recommended in the Addendum report; rather, he ordered only an ultrasound examination of Patient J.S.'s left breast because an ultrasound examination of the right breast had been done on January 3, 2001, and Dr. Byrd felt that no new information would be obtained from another ultrasound examination of Patient J.S.'s right breast. Dr. Byrd was also concerned that Patient J.S.'s insurance company might not pay for another ultrasound examination of her right breast and that she would have to pay for the examination. Dr. Byrd did not include in the medical record of Patient J.S.'s January 29, 2001, office visit a notation that he performed an examination of Patient J.S.'s breasts. According to Dr. Byrd, one can infer that he examined Patient J.S.'s breasts from the notation on the record that he detected cystic structures on her left breast and from the fact that Patient J.S.'s complaint was noted on the medical record as pain in her right breast. The only notation on the medical record regarding Patient J.S.'s complaint of a lump in her right breast was "Large mass ?". There is no mention in the medical records of the January 29, 2001, office visit that Dr. Byrd discussed with Patient J.S. the results of the mammogram, ultrasound of the right breast, or the addendum to the mammogram. Dr. Byrd did not recall Patient J.S. requesting at the January 29, 2001, office visit a referral for a biopsy, but he did recall that Patient J.S. was very anxious about what she perceived as a lump in her right breast. Even though he could not palpate a lump in the location indicated by Patient J.S., in light of the suspicions in the report of the January 3, 2001, mammogram examination of the right breast and in the addendum to this report, Dr. Byrd would "probably" have referred her for a biopsy on January 29, 2001, if she had asked him to do so. In Dr. Byrd's opinion, however, there was no clinical indication in his physical examination of Patient J.S.'s breasts on January 29, 2001, or in the reports of the mammography examination and addendum or in the ultrasound examination of her right breast to indicate that he should refer Patient J.S. for a biopsy of her right breast. The ultrasound examination of Patient J.S.'s left breast was done by Boston Diagnostic Imaging on March 7, 2001, and the report was dictated on March 9, 2001. According to the report, the ultrasound examination of Patient J.S.'s left breast correlated with the results of the mammography examination and showed multiple cystic regions in Patient J.S.'s left breast, ranging in size from 1 mm to 3 mm. in diameter. The radiologist noted that the cysts were benign. Dr. Byrd received and initialed the report of the March 7, 2001, ultrasound, but he did not discuss the results of the ultrasound with Patient J.S. Patient J.S. became concerned because the lump she felt in her right breast was getting bigger, and she called Dr. Byrd's office and scheduled another office visit for June 11, 2001. When she called to make the appointment, she told Dr. Byrd's nurse that the lump was getting bigger. Dr. Byrd did not examine Patient J.S. during the June 11, 2001, office visit. Rather, Patient J.S. was seen by Dr. Byrd's physician's assistant, who noted on the medical record of the office visit that "Pt wants referral for breast Bx." Dr. Byrd's physician's assistant did not examine Patient J.S.'s breasts during the June 11, 2001, office visit, but Dr. Byrd, when he reviewed the physician's assistants notes of the June 11, 2001, office visit, approved a referral to a general surgeon for a breast biopsy. Patient J.S. called Dr. Jeffrey Smith on Dr. Byrd's referral. Dr. Smith advised Patient J.S. to get an updated mammogram and ultrasound examination of her right breast. Before she obtained these tests, however, Dr. Smith performed a core needle biopsy of the mass in her right breast that produced a finding that the mass was benign. Mammography and ultrasound examinations of Patient J.S.'s right breast were performed at Boston Diagnostic Imaging on July 13, 2001, and both the mammogram and ultrasound indicated a mass in the upper outer quadrant of Patient J.S.'s right breast, at the 11:00 o'clock position, that was "highly suggestive of malignancy." The radiologist called his report in to Dr. Smith and strongly recommended a biopsy. Dr. Smith performed a lumpectomy that produced a finding that the mass was malignant. Patient J.S. had a mastectomy of her right breast, followed by chemotherapy. Standard of Care Dr. Byrd was required to practice medicine in his care of Patient J.S. with "that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances." Based on the credited opinions of George Wilson, M.D., Dr. Byrd's treatment and care of Patient J.S., violated the standard of care for the following reasons. Even though a family practice physician is justified in relying on the findings, impressions, and recommendations of a radiologist, the standard of care applicable to family practice physicians under the circumstances presented in this case requires the physician to assess all of the information available to him or her and to refer the patient for further evaluation if medically indicated. Specifically, when a female patient presents with a complaint that she has felt, or even has possibly felt, a lump in her breast, the standard of care requires a family practice physician to rule out a malignancy. In this case, at the time of Patient J.S.'s January 29, 2001, office visit, Dr. Byrd had available the information that Patient J.S. believed that she had detected a lump in her right breast and that she was experiencing pain in her right breast; the report of the January 3, 2001, bilateral mammography examination, in which the radiologist reported an abnormality in the form of an "asymmetric 2 cm nodular density located in the 12 o'clock position of the right breast posteriorly," the general area in which Patient J.S. had reported feeling a lump; and the Addendum report dictated on or about January 15, 2001, in which the radiologist reported that a comparison of the January 3, 2001, mammography examination and a 1995 mammography examination showed that the two-centimeter mass in Patient J.S.'s right breast, as well as two "densities" in her left breast, were either "significantly" or "slightly" larger than they were in 1995. Even though it was reasonable for Dr. Byrd to rely on the recommendations of the radiologist, there were inconsistencies in the recommendations included in the "FINDINGS" and "IMPRESSIONS" sections of the reports, though not in the substantive observations, of the radiologist's reports of the January 3, 2001, ultrasound and mammography examinations, as well as in the Addendum report. Dr. Byrd did not, however, contact the radiologist to clarify any of these inconsistencies when formulating his treatment plan for Patient J.S. Nonetheless, the information available to Dr. Byrd in late January 2001, taken together, was sufficient to warrant the referral of Patient J.S. for further evaluation of her right breast, either to a radiologist for a mammography cone compression view focusing on the area in which the two centimeter mass appeared or to a general surgeon for a biopsy of the two centimeter mass. The evidence presented clearly and convincingly establishes that Dr. Byrd violated the standard of care applicable to family practice physicians under similar circumstances as those presented in this case because he failed to refer Patient J.S. for further evaluation of her right breast on the basis of her complaint and of the substantive information included in the mammography reports. Dr. Byrd's care and treatment of Patient J.S. did meet the standard of care in the following respects, again based on the credited testimony of Dr. Wilson: Dr. Byrd's referral of Patient J.S. to Boston Diagnostic Imaging for bilateral mammography and an ultrasound examination of the right breast after her contact with his office on December 27, 2000, was consistent with the standard of care for family practice physicians under the circumstances. Likewise, Dr. Byrd did not deviate from the standard of care by making this referral without having conducted an examination of Patient J.S. and prior to referring Patient J.S. to a general surgeon for a biopsy. Finally, Dr. Byrd's failure to diagnose Patient J.S. as having a malignant mass in her right breast did not constitute a deviation from the standard of care applicable to family practice physicians because, under the applicable standard of care, a family practice physician is not expected to make such a diagnosis. Medical Records The medical record of Patient J.S.'s contact with Dr. Byrd's office on December 27, 2001, does not meet Florida's standards for medical records. The entry for December 27, 2000, when Patient J.S. contacted Dr. Byrd's office complaining that she felt a lump in her right breast, was included only as a note inserted in the medical record of an office visit on November 15, 2000. Although the note indicates that Patient J.S. was given a prescription for a mammogram and ultrasound, it cannot be determined from the note whether Patient J.S. visited Dr. Byrd's office on December 27, 2000; who she communicated with regarding her complaint; or whether she was examined or by whom.9 Although Dr. Byrd made a notation on the report of the January 3, 2001, bilateral mammography examination issued by Boston Diagnostic Imaging that Patient J.S. should be given a copy of the report, there is nothing in the medical records submitted into evidence documenting the actual transmittal of the report to Patient J.S. Similarly, although Dr. Byrd made a notation on the second report, which was misidentified as a report of the bilateral mammography examination, that Patient J.S. was "aware" that she should follow-up with an ultrasound examination in six months, there is nothing in the medical records submitted into evidence documenting how, when, and by whom Patient J.S. was made "aware" of the need for a follow-up examination or any instructions that were given to Patient J.S. for follow-up. The medical record maintained by Dr. Byrd of Patient J.S.'s office visit on January 29, 2001, does not meet Florida's standards for medical records: Portions of the medical record are illegible. There is no clear indication that Dr. Byrd conducted a breast examination during that office visit. Rather, Dr. Byrd testified that it must be inferred from the notations in the medical record that he did an examination of Patient J.S.'s right and left breasts. There is no indication in the medical record of the results of an examination of Patient J.S.'s right breast. The marks in the boxes by which the results of the "Health Examination" are recorded are sloppy; it is difficult to determine whether Dr. Byrd examined Patient J.S.'s "chest/lungs" or "heart" or both and whether the results were normal or abnormal; and Dr. Byrd admittedly erroneously indicated by a checkmark that he had examined Patient J.S.'s "genitals and anus" and that the results were abnormal. Dr. Byrd's assessment of Patient J.S.'s condition at the January 29, 2001, office visit was "mastodynia," or pain in the breast, which merely confirmed Patient J.S.'s complaint, and there is no data in the medical record to support the assessment. There is no indication in the medical record that Dr. Byrd explored the possible cause of the breast pain by questioning Patient J.S. or by examination. Finally, there is no indication in the medical record for the January 29, 2001, office visit that Dr. Byrd discussed with Patient J.S. the results of the bilateral mammography examination, of the ultrasound examination of her right breast, or of the results of the comparison of the 1995 and 2001 mammography examination results. Prior disciplinary history Two previous disciplinary actions have been filed against Dr. Byrd. In both cases, the actions were resolved without resort to an administrative hearing. The first action arose out of an Administrative Complaint in which Dr. Byrd was charged with having failed to practice medicine within the acceptable level of care; with failing to maintain appropriate medical records; with having inappropriately prescribed medication to a patient; and with delegating professional responsibilities to a person not qualified to perform the duties. A Final Order was entered on January 7, 1999, as a result of a Consent Order in which Dr. Byrd neither admitted nor denied the facts alleged in the Administrative Complaint. The Board reduced the fine specified in the Consent Order to $1,000.00; deleted in toto the suspension set forth in the Consent Order; and adopted the requirements in the Consent Order that Dr. Byrd attend a drug course and a medical records course and undergo a quality assurance review. The second action arose out of an Administrative Complaint in which Dr. Byrd was charged with having failed to comply with the 1999 Final Order. A Final Order was entered in the second action on December 13, 2000, as a result of a Consent Order in which Dr. Byrd neither admitted nor denied the facts alleged in the Administrative Complaint. The Board adopted the Consent Order in toto and required Dr. Byrd to appear before the Board and pay investigative costs in the amount of $415.96.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding the Bill Byrd, M.D., is guilty of having violated Section 458.331(1)(m) and (t), Florida Statutes, and Issuing a reprimand to Dr. Byrd; Imposing an administrative fine in the amount of $12,000.00; Placing Dr. Byrd on probation for a period of two years under such terms and conditions as the Board shall deem appropriate; and Requiring Dr. Byrd to complete a medical records course approved by the Board. DONE AND ENTERED this 9th day of June, 2006, in Tallahassee, Leon County, Florida. S PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 9th day of June, 2006.
The Issue As stipulated by the parties on February 1, 1994, this single contested issue of law remains for disposition: May the Petitioner terminate the Respondent's employment as a custodian at Wekiva Elementary School for just cause, as an act or acts endangering the health, safety, or welfare of any employee of the district, (or for any substantially similar offense), when said act, which was, as stipulated, the repeated striking of Sallie Jenkins, the principal of Wekiva Elementary School (on the 27th of April, 1993), occurred as a direct result of Respondent's thyroid dysfunction due to Respondent's failure to appropriately medicate himself with his thyroid replacement medication after his thyroidectomy?
Findings Of Fact Leroy McMillon (McMillon) is, and was at all times relevant, a non- instructional employee (custodian) at Seminole County School District's Wekiva Elementary School in Seminole County, Florida. On April 27, 1993, during the school day and when both individuals were employed by the school board, McMillon attacked Wekiva Elementary School Principal, Sallie Jenkins, striking her repeatedly and injuring her. McMillon and the Seminole County School Board had been involved in a previous employment termination action before an arbitrator under the collective bargaining grievance procedure. The termination action had been brought by Principal Jenkins. The result of the action was that McMillon was reinstated, but without pay for the period that he had been suspended from work. At all times prior to, and during McMillon's suspension, and thereafter subsequent to his reinstatement, McMillon and his supervisor, Sallie Jenkins, were having employment relation problems. Prior to and during the period of his suspension, and subsequent to his reinstatement after arbitration, McMillon failed to take his thyroid replacement medication. He had surgery in 1992, a thyroidectomy, after which operation he was advised to take thyroid replacement medication. On September 17, 1993, McMillon was examined by Richard C.W. Hall, M.D., an expert recognized in the field of thyroid dysfunction, at Florida Hospital Center for Psychiatry, in Orlando, Florida. Dr. Hall concluded that, "...[t]here is a reasonable medical certainty that the patient's mental state was altered by the acute absence of thyroid medications at the time that [the attack] occurred. The symptoms are characteristic of sudden disruption in levels of thyroid hormone." p. 7, Hall Evaluation, Joint Exhibit #1
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That the Seminole County School Board enter its final order denying the superintendent's recommendation for termination of Leroy McMillon and dismissing the administrative complaint. DONE AND RECOMMENDED this 11th day of May, 1994, in Tallahassee, Leon County, Florida. MARY CLARK 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 11th day of May, 1994. COPIES FURNISHED: Ned N. Julian, Jr., Esquire Post Office Box 4848 Sanford, Florida 32772 H. Scott Gold, Esquire 703 East Pine Street Orlando, Florida 32801 Douglas L. "Tim" Jamerson Commissioner of Education The Capitol Tallahassee, Florida 32399-0400 Dr. Paul Hagerty, Superintendent Seminole County School Board 1211 South Mellonville Avenue Sanford, Florida 32771
The Issue At issue is whether Samuel Hess, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact Stipulated facts Jeffrey Hess and Jeanmarie Hess are the natural parents of Samuel Hess, a minor. Samuel was born a live infant on January 7, 2002, at St. Vincent's Medical Center, a licensed hospital in Jacksonville, Florida, and his birth weight exceeded 2,500 grams. The physician providing obstetrical services at Samuel's birth was Karen D. Bonar, M.D., who, at all times material hereto, was a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Coverage under the Plan Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain . . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat. Here, Petitioners are of the view that Samuel suffered such an injury. More particularly, Petitioners believe Samuel's neurologic impairments are the result of a brain injury caused by hydrocephalus, secondary to an intraventricular hemorrhage (diagnosed at six days of life), that was precipitated by oxygen deprivation (a hypoxic ischemic insult), and which occurred during labor and delivery. In contrast, NICA is of the view that Samuel's impairments are most likely developmentally based, as opposed to birth related, and that, whatever the etiology of Samuel's impairments, he is not permanently and substantially physically impaired. Samuel's birth and immediate newborn course At or about 12:55 p.m., January 7, 2002, Mrs. Hess, with an estimated delivery date of January 21, 2002, and the fetus at 38 weeks' gestation, was admitted to St. Vincent's Medical Center, following spontaneous rupture of the membranes, with clear fluid noted, at 9:00 a.m. On admission, mild, irregular contractions were noted; vaginal examination revealed the cervix at 2 to 3 centimeters dilation, 60 percent effacement, and the fetus at -1 station; and fetal monitoring was reassuring for fetal well-being, with a baseline of 120 to 130 beats per minute. Given rupture of the membranes, Mrs. Hess was committed to deliver, and she was admitted for pitocin augmentation. Following admission, an IV was started at 1:48 p.m.; an epidural was placed at 3:56 p.m.; pitocin drip was started at 4:05 p.m.; Mrs. Hess was noted as pushing at 9:24 p.m.; and Samuel was delivered spontaneously at 10:24 p.m., with "Nu[cal]/Hand" (the umbilical cord wrapped around the hand) noted. In the interim, staring at or about 8:00 p.m., monitoring revealed, over time, late decelerations; marked decelerations with slow return to baseline; and evidence of a hypertonic uterus (starting at 9:24 p.m., and persisting, following periods of relaxation, until 10:22 p.m.), with exaggerated fetal heart rate variability. Such a pattern is consistent with fetal stress, and raises concerns regarding fetal reserves and adequate oxygenation. However, at delivery, Samuel was not depressed; did not require resuscitation; was accorded normal Apgar scores of 8 and 9, at one and five minutes, respectively, reflective of a healthy newborn2; and no abnormalities were observed at birth, except pronounced molding.3 Following delivery, Samuel was transferred to the nursery, and ultimately discharged with his mother on January 10, 2002. In the interim, Samuel's newborn course was normal, except for evidence of mild jaundice (diagnosed the morning of January 9, 2002), which did not require light therapy. However, on discharge, instructions were given to follow-up the next day at the Seton Center for a repeat bilirubin check. As instructed, Mrs. Hess presented with Samuel at the Seton Center on January 11, 2002, for a repeat bilirubin check. At the time, Samuel was noted to be active, alert, and in no apparent distress; his temperature was recorded as normal (as it had been following delivery, and during his admission in the nursery at St. Vincent's Medical Center); his newborn examination, apart from evidence of jaundice, was within normal limits; and Mrs. Hess reported that Samuel had fed well.4 The results of the bilirubin test were obtained at or about 1:30 p.m., that afternoon, and called to a staff physician (Dr. Vaughn), who gave instructions to initiate phototherapy. Accordingly, later that afternoon, Samuel was put under the bilirubin lights at home, with instructions to monitor his temperature every two hours. On January 12, 2002, Samuel recorded a temperature of 100.6, and on the instructions of Dr. Vaughn, Samuel was taken to the emergency room at Wolfson Children's Hospital for evaluation.5 There, Samuel was received at 6:35 p.m., and triaged at 6:42 p.m. Chief complaint was jaundice, and temperature was noted as 100.7, otherwise no abnormalities were observed. Samuel's physical examination and immediate hospital course were documented, as follows: PHYSICAL EXAMINATION: His temperature is 100.7 in the ER. The rest of his vitals are normal. His weight is 2.7 kg. He is resting, easily aroused. Anterior fontanelle is soft and flat, with normal sutures. Has good red reflexes bilaterally. Ear canals are patent. Nose without congestion. Oropharynx is clear, no cleft. Heart is normal S1 and S2 without murmurs. Abdomen is soft and nontender. Chest is clear to auscultation. Extremities are without rashes, cyanosis, clubbing or edema. He does have good femoral pulses bilaterally, and no hip clicks. Neurologically, he is alert and active . . . . LABORATORY: . . . Total bilirubin on admission was 14.2, direct was 0.5. He was tapped, and had a white count in his spinal fluid of 2,500 and red count of 241,250. He had 65 segs, 17 lymphocytes and 18 monocytes, and the spinal fluid Gram stain showed no organisms, but an occasional leukocyte. IMPRESSION AND PLAN: My impression is that we have a six-day-old with fever and abnormal leukocytosis in his spinal fluid. He was placed on ampicillin, and gentamicin . . . . He was also cultured for herpes [, which was negative]. He was started on Acyclovir 20/kilo q.8 hours. He will continue to feed. A repeat spinal tap was attempted to clear up the meningitis issue on two occasions; however, both times they were bloody. We, therefore, are going to obtain a head CT with contrast to rule out an intracranial bleed. A CT of the head was done on January 13, 2002, and revealed a bilateral intraventricular hemorrhage (IVH) and a left posterior parietal cephalohematoma.6 The CT scan was read, as follows: FINDINGS: There is molding of the bones of the calvarium, compatible with recent vaginal delivery. Curvilinear area of increased density identified within the scalp soft tissues in the left posterior parietal region, compatible with a cephalohematoma. Increased densities identified within the lumen of the left lateral ventricle, predominantly involving the left choroid plexus, but also layering in the dependent portion of the lateral ventricle, compatible with intraventricular hemorrhage from the choroid plexus bleed. In addition, increased density is identified in the dependent portion of the right lateral ventricle consistent with intraventricular hemorrhage. No extra axial fluid collections are identified. Linear area of increased density is identified in the right frontal region, only seen on images #11, and therefore likely not due to subarachnoid hemorrhage. The ventricular system is not dilated. No focal parenchymal mass is identified. After contrast administration, there are no abnormal areas of parenchymal or meningeal enhancement identified. IMPRESSION: Left posterior parietal cephalohematoma Bilateral intraventricular hemorrhage, left greater than right, with the left intraventricular hemorrhage due to choroid plexus bleed. Molding of the bones of the calvarium compatible with history of recent vaginal delivery . . . . Given the abnormalities reported on the CT scan, Dr. Randell Powell, a neurosurgeon, was requested to see Samuel for neurosurgical input. That consultation occurred on January 16, 2002,7 and was reported, as follows: . . . I have been requested to see the child for neurosurgical input. I am informed that the baby is now doing well. Septic work-up was completely negative and antibiotics have since been discontinued and the baby is anticipating discharge later on today. PHYSICAL EXAMINATION: Reveals a beautiful, sleeping, male infant with a very soft head, a very soft fontanelle, no splitting of the sutures. The head circumference is measured to be slightly less than the 50th percentile for a newborn. There is no nuchal rigidity and bending the legs did not appear to cause irritation as well. The child has a bilateral red reflex. Pupils are equal and reactive. The Moro reflex is symmetric. Computed tomographic scan shows hemorrhage emanating from the choroid plexus and the trigone of the left lateral ventricle. There is mild ventricular dilatation. Follow-up ultrasound shows similar findings. IMPRESSION: Intraventricular hemorrhage. DISCUSSION: Intraventricular hemorrhages in the newborn perinatal period that are caused by choroid plexus hemorrhage generally have an excellent prognosis as no significant brain parenchyma is disrupted and these hemorrhages usually resolve without sequelae. However, there is roughly a 20% chance of developing post hemorrhagic hydrocephalus which in 50% of cases could require more aggressive treatment. That means the baby's chances of needing neurosurgical intervention is somewhat less than 10% and this was discussed extensively with the parents who were happy to hear this news. There are no overt signs of hydrocephalus at this time and in my opinion I think that we can safely follow the baby with serial physical examination consisting of palpation of the fontanelle and head circumference measurements. I would be glad to see the baby at age one month for follow- up, but I suspect a good prognosis here. Samuel was discharged from Wolfson Children's Hospital at 6:15 p.m., January 16, 2002, with instructions to monitor his head circumference once a week, and for follow-up appointments with Dr. Hamaty (his pediatrician at the time8) and Dr. Powell. Samuel's subsequent development Following discharge, Samuel was followed by Dr. Powell for mild posthemorrhagic hydrocephalus, that appeared to stabilize, but then got worse between ages four and six months.9 Serial studies showed progressive ventricular enlargement consistent with hydrocephalus, and after discussing treatment options Samuel's parents elected to proceed with endoscopic third ventriculostomy, which was performed on August 26, 2002. Initially, Samuel appeared to be doing reasonably well, but then he developed an accelerated head circumference (53.8 centimeters, which placed him above the 98th percentile), consistent with progressive hydrocephalus, and on December 6, 2002, a Codman programmable ventriculoperioneal shunt was placed. Since that time, Samuel has done fairly well, without symptoms related to increased intracranial pressure. However, he continues to evidence macrocrania (above the 98th percentile), ventriculomegaly (enlargement of the laterial ventricules), and atrophy of brain tissue.10 (Exhibit 34). Samuel's current presentation With regard to Samuel's current presentation, the parties agree, and the proof is otherwise compelling, that Samuel is permanently and substantially mentally impaired.11 As for his physical presentation, while there may be room for disagreement, the complexity of Samuel's difficulties support the conclusion that he is also permanently and substantially physically impaired. In so concluding, it is noted that on the Vineland Adoptive Behavior Scales Form (VABS), related to daily living skills and motor skills, Samuel scored in the mentally handicapped range. "He is not yet toilet trained despite intensive efforts in this regard"; "[h]e is able to assist with simple dressing and undressing tasks but is not yet independent with these skills"; and he "continues to display gross-motor, fine-motor, visual-motor, and motor planning impairment." (Exhibits 18 and 30). It is further noted that Samuel presents with impaired postural control (aggravated by his large head), impaired strength, hypotonia, and bilateral pronatal feet. As a result, Samuel has moderate to severe impairment in strength, endurance, postural control, balance responses (with unexpected falls), functional mobility, and activities of daily living. Notably, at approximately five years of age, Samuel requires a stroller for extended outings, and caregiver assistance for 90 percent of self care needs. (Exhibit 10). The cause of Samuel's impairments As for the cause of Samuel's neurologic impairments, the proof demonstrates that, more likely than not, they are the result of a brain injury, caused by hydrocephalus, secondary to the intraventricular hemorrhage (IVH) he suffered, and which was diagnosed at six days of life. What remains to resolve is the genesis of Samuel's IVH or, stated otherwise, whether the proof demonstrated, more likely than not, that the IVH was caused by oxygen deprivation, and occurred during labor, delivery or resuscitation. § 766.302(2), Fla. Stat. ("'Birth-related neurological injury' means injury to the brain . . . caused by oxygen deprivation . . . occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period."); Nagy v. Florida Birth-Related Neurological Injury Compensation Association, 813 So. 2d 155 (Fla. 4th DCA 2002)(The oxygen deprivation and injury to the brain must occur during labor, delivery, or immediately afterward.). The genesis of Samuel's IVH Regarding the intraventricular hemorrhage Samuel suffered, the proof is compelling that an IVH in a term infant, such as Samuel, is a rare occurrence, and its cause frequently cannot be identified. Indeed, among the physicians who addressed the issue, there is apparent agreement that the majority of IVHs (approximately 50 percent) are related to oxygen deprivation (hypoxia-ischemia) or trauma, and the remainder fall into one of two groups, those with another identifiable cause (such as vascular malformation, infection, clotting disorder, venous infarct, or genetic disorder) and those of unknown etiology (idiopathic). To address the cause and timing of Samuel's IVH, the parties offered the deposition testimony of Julius Piver, M.D., J.D., a physician board-certified in obstetrics and gynecology (albeit one who has not practiced obstetrics for 20 years); Mary Edwards-Brown, M.D., a physician board-certified in radiology, with subspecialty certification in neuroradiology; David Hammond, M.D., a physician board-certified in pediatrics, neurology with special competence in child neurology, and clinical neurophysiology; Donald Willis, M.D., a physician board-certified in obstetrics and gynecology, and maternal-fetal medicine; and Michael Duchowny, M.D., a physician board- certified in pediatrics, neurology with special competence in child neurology, electroencephalography, and clinical neurophysiology.12 The testimony of Doctors Piver, Edwards- Brown, and Hammond were offered in support of Petitioners' view on causation, and testimony of Doctors Willis and Duchowny were offered in support of NICA's view on causation. Pertinent to the issue of causation, Doctors Piver, Edwards-Brown, and Hammond were of the opinion that an infant can suffer a intraventricular hemorrhage during labor and delivery, as a result of a hypoxic-ischemic insult, and not show any clinical evidence in the immediate postnatal period. However, although offered the opportunity to do so, Dr. Hammond declined to offer an opinion as to the likely etiology (cause and timing) of Samuels IVH.13 Consequently, we are left to consider the testimony of Doctors Piver and Edwards-Brown with regard to Petitioners' view on causation. As for the etiology of Samuel's IVH, it was Dr. Piver's opinion, based on his review of the medical records, that Samuel's IVH was most likely caused by partial prolonged asphyxia, that was sufficient to cause a subtle, slow bleed during labor and delivery, which progressed to the significant IVH noted at 6 days of life, but that was initially insufficient to reveal itself (by clinical evidence of a bleed) in the immediate postnatal period. In reaching his conclusion, Dr. Piver relied heavily on his evaluation of the fetal monitor strips, which he opined revealed, starting at 6:48 p.m. (18:48), and continuing for 30 to 35 minutes, evidence of marked loss of beat-to-beat variability; late decelerations at 8:01 p.m., 8:03 p.m., 8:05 p.m., 8:25 p.m., 8:28 p.m., 8:31 p.m., and 8:33 p.m.; a marked deceleration to a low of 70 beats per minute at 8:50 p.m., with a slow return to baseline at 8:56 p.m.; a marked deceleration from 180 beats per minute to 90 beats per minute between 9:14 p.m. to 9:20 p.m.; a late deceleration at 9:23 p.m.; and evidence of a hypertonic uterus starting at 9:24 p.m., and persisting to 9:42 p.m., again at 9:50 p.m., and persisting to 10:14 p.m., and again at 10:20 p.m. and persisting to 10:22 p.m., with exaggerated fetal heart rate variability. While acknowledging the bleed could have started at any time between the 7th of January (Samuel's delivery date) and the 12th of January, when Samuel presented to Wolfson Children's Hospital, Dr. Piver was of the opinion, given his review of the fetal monitor strips, that Samuel's bleed was most likely caused by hypoxia, and that it began during labor and delivery. Dr. Piver variously noted the likely onset of the bleed as "[b]etween 2030 and 2130 hours"; "around 2000 hours"; "from 2000 hours to 2130 hours"; "between 1800 and 2224 hours"; "between 1800 and 2100 hours"; and "the 21:24 to 22:20 time interval." (Exhibit 23, pages 34, 48, 49, 57, 80, 82; Exhibit 23, deposition Exhibit 6). Dr. Edwards-Brown, like Dr. Piver, was of the opinion that Samuel's IVH was most likely caused by hypoxia, that caused a slow bleed during labor and delivery, but an insufficient bleed to reveal evidence of brain damage during the immediate postnatal period. Dr. Edwards-Brown's opinion was explained, as follows: Q How are you able to determine, based on the films that you reviewed, that the hemorrhage began during labor and delivery? A Based on the films alone, we can't make that determination. It's simply the path of physiology of the hemorrhages and the hospital course as well as the labor and delivery records that allow me to make that conclusion. * * * Q Are you able to look at the effect of the hemorrhage on the brain structures to determine or time when the hemorrhage may have occurred? A What I see is a large hemorrhage wherein the ventricle that is pretty bright and that hemorrhage is causing hydrocephalus; and the hydrocephalus, I'm sure, is causing symptoms, but hemorrhages don't cause hydrocephalus initially. It takes some time before that occurs. So all I can say is yes, the hemorrhage is having an effect on the brain, and that effect is hydrocephalus and ischemia, and it could have occurred sometime from the time of labor and delivery until the time that film was obtained. Q It could have occurred at any time in between there? A. The hydrocephalus and the ischemia. Q But not the hemorrhage? A Certainly the hemorrhage could have occurred after birth, but I would have expected some evidence of that in the clinical history. I would have expected evidence that this child had suffered a profound hypoxic injury as one might see if this child had had a code or a profound drop in his oxygen status. None of that is in the record; therefore, I don't think it's a post natal event. * * * Q Okay. How are you able to rule out in this case that the hemorrhage did not begin on January 9th, 10th, 11th or 12th? A Several things. Number one, I don't have evidence on the 9th, 10th, 11th, or 12th of January that this child suffered any hypoxic injury. Q Hemorrhage [can] be caused by something other than hypoxic injury? A It can. Q Okay, and what are the other possible causes? A Intraventricular hemorrhage might result from a tumor, might result from a vascular malformation, it could result from an infection, but it usually results from hypoxia. Q We sometimes do not know what causes intraventricular hemorrhage? A I think when we don't know what causes intraventricular hemorrhage, it is a reasonable presumption that there was hypoxia at a time when someone was not looking, as in the prenatal or labor and delivery period. If there wasn't a fetal heart monitoring strip obtained during that period and the child is born with -- excuse me, with intraventricular hemorrhage, I think the presumption should be that there was hypoxia during that time. But certainly there may be some times when we don't have an answer. Q Sometimes we simply don't know what caused the hemorrhage? A That is undeniably true; however, one should not make that presumption until we have excluded the usual causes. And in this case, based on Dr. Piver's testimony that there was evidence of hypoxia during labor and delivery, one must assume that that was the cause. We don't make the diagnosis of an idiopathic cause. That means we don't have the answer when we have evidence of a reasonable cause, which we have here. Q In your letter to Mr. Sharrit that we referred to earlier, you state on Page No. 2 further down that, "The absence of symptoms in the three days following birth is not unusual since bleeding begins small and increases with time." What do you mean by that? A That's the nature of bleeding. I'm sure you know this. We have all bled. You don't -- Well, bleeding -- unless it's the result of an aneurism -- is not so massive initially. It starts out as a leak in the vessels, and the longer it bleeds the more it accumulates . . . . (Exhibit 27, pages 39, 41, 42, 44-46). Contrasted with the opinion held by Doctors Piver, Edwards-Brown, and Hammond, Doctors Willis and Duchowny were of the opinion that if a hypoxic event is significant enough to cause an intraventricular hemorrhage during labor and delivery, there will be clinical evidence in the immediate newborn period. Dr. Willis expressed his observations on the medical records, as well as the basis of his opinions on causations, as follows: Q . . . Dr. Willis, in reviewing the records and the fetal heart tracings, were you able to identify any intervals, any intervals of concern, I suppose, or any that you thought that may have been hypoxic intervals? A Well, the fetal heart rate monitor strip looks pretty good until about an hour and a half before delivery, and then there are fetal heart rate decelerations that pretty much continue until the time of birth. Q And what was the significance of those intervals that you're talking about, to you? A Well, the decrease in fetal heart rate usually means that there's some decrease in oxygen supply to the baby. Q Okay. A Or umbilical cord compression, which could lead to that same thing. Q So are you saying you found intervals that were suspicious for oxygen compromise? A That's correct. Q Did you identify intervals of lack of beat-to-beat variability that you thought were of concern? A Well, I'll look, but most of what I saw were fetal heart rate decelerations along with really exaggerated fetal heart rate variability, which usually you see with umbilical cord compression. Q Well, are you saying, then, that there were episodes in this case where you felt there was significant cord compression? A Well, the fetal heart rate tracing certainly is consistent with umbilical cord compression. Q And over what time period would you say the fetal heart tracings are consistent with cord compression? A Well, off and on for the last hour and a half prior to birth. Q And could that create a scenario, an hypoxic scenario that could lead to some kind of vascular insult within the brain? A Now, let me be sure I understand the question. Are you asking me if I believe this fetal heart rate pattern, the abnormalities that I see led to that or can abnormalities in fetal heart rate pattern in general lead to brain injury? Q I guess my question would be, the pattern that you've identified in this case, is that consistent with a pattern that can lead to injury, vascular injury within the brain? A Well, I think it shows that there's probably some lack of oxygen during that time period. Now, the question then is, you know, did that lack of oxygen lead to brain damage. And in this case, you know, my feeling is or my opinion is that it did not lead to brain damage. Q Let's break that up a little bit. Without knowing, without looking at the final result -- I presume you're looking at the early neonatal period right after birth to help you make that conclusion. Am I correct? A Yes. Q If we for the moment put aside the early clinical course of the child, just by looking at the heart tracings and the patterns that you've identified, are those consistent with or perhaps suspicious for the kind of pattern that could lead to a fetal compromise, brain compromise? A Well, I don't know if anyone could predict fetal brain damage simply based on a fetal heart rate pattern. You really have to look at the baby, the condition of the baby after birth to be able to say whether or not the abnormalities in the fetal heart rate pattern resulted in oxygen deprivation and brain injury. * * * Q Now, you did, no doubt, note that the child did return to the hospital after discharge and was found to have a bloody spinal tap, and ultimately it was determined that it had an intraventricular hemorrhage? A That's correct. That's, I believe, on the fifth day after birth. Q Well, having identified hypoxic consistent patterns within the fetal heart tracings, how is it that you can say that perhaps did not lead to a vascular insult that slowly progressed over a period of four or five days into an extensive hemorrhage? * * * A . . . I think that it's pretty clear that if you're going to have an hypoxic injury to the brain that's substantial enough to cause brain injury then the baby really is going to be depressed at time of birth and is going to have an unstable newborn period. Simply having an abnormal fetal heart rate pattern is not enough to say that any lack of oxygen that occurred during labor caused brain damage. Q . . . And I guess you're saying across the board and without exception there can be no slowly progressing brain damage that can occur due to labor and delivery hypoxia? A Well, in order to have an hypoxic event during labor or delivery that would be substantial enough to cause an hypoxic- related brain injury, then really the baby is going to have to be depressed at birth. Now, I mean, you can have intracranial hemorrhages, choroid plexus bleeds in babies that have normal, spontaneous vaginal births with normal-looking fetal heart rate tracings. I mean, there are spontaneous hemorrhages that can occur during labor, delivery, at some point after the baby is born, in the newborn period. But what I'm saying is that if you're going to have an intracranial hemorrhage due to an hypoxic event during labor or delivery, then the baby really should be depressed at time of birth and have an unstable newborn course. Q When you say depressed after the birth, do you put any outer limit on the time frame during which the baby might become depressed? A Well, usually, by the newborn -- by the immediate post-delivery period they mean immediately after birth and until the baby is essentially stabilized after birth. For instance, in this case the baby had Apgar scores of eight and nine, required no resuscitation at all. So, you know, we really don't have anything to suggest that there's a problem in the immediate newborn period. And then during the hospital stay, other than the jaundice, the baby did not really have any problems. The baby breast-fed. It did not have any neurologic findings that were abnormal, didn't have renal failure, did not have seizures, you know, the types of things that we see with babies that suffer an hypoxic insult during labor or delivery. * * * Q I know that your opinion is that if an hypoxic event is significant enough to cause a brain damage, then you're going to have to necessarily see signs of depression at birth or shortly after birth. Am I stating that correctly? A Very nicely. Q Okay. What if we're not talking about brain damage or encephalopathy in the broad sense but we're just talking about a very small insult to one of the blood vessels in the brain that doesn't readily turn into brain damage but, rather, becomes a progressive problem over a period of several days? Is that a possible scenario? A I guess most things are possible, but that seems unlikely to me. Q It seems unlikely to you that you could have a weakening of a blood vessel or some injury that lessens the integrity of the blood vessel and that the brain damage is then latent and that's perhaps the reason why it would not negatively impact the early clinical course? A Well, let me say -- and I think we kind of went over this before -- that you can have intracranial hemorrhages on babies that have no apparent problems at all during labor, delivery. Just for reasons unknown you can have intracranial hemorrhage and blood vessels can rupture. But I guess what we're talking about is brain injury due to lack of oxygen or mechanical trauma. And my point being that if you're going to get a hemorrhage due to lack of oxygen or mechanical trauma, then the baby really should be depressed at time of birth (Exhibit 28, pages 23-30). Dr. Duchowny expressed his observations of the medical records, as well as his opinions on causation, as follows: Q. Let me at this time suggest a brain injury pathway that has been offered by others in this case for Samuel Hess and ask you to comment on that. Others have suggested that in this case there was labor and delivery hypoxia that resulted in a choroid plexus bleed and was associated with an isolated -- excuse me, where the blood was isolated -- the bleed was isolated within the ventricles during the pre-natal course and that that later produced hydrocephalus -- MR. BAJALIA: Pre-natal? MR. SHARRIT: Yes, in the first few days after birth. Q. Are you with me, doctor? A. Yes, I am, but I think you mean post- natal course. Q. I'm sorry, I'm sorry. I do. Thank you. Labor and delivery hypoxia, the choroid plexus bleed isolated within the ventricles during the post-natal course that later produced hydrocephalus and increased the internal cranial pressure that later after - - well after discharge from the hospital resulted in periventricular white matter damage. Is that a reasonable interpretation for Samuel Hess' brain injury? A. No. Q. Why not? A. There's no evidence of hypoxia. * * * Q. . . . [Y]ou don't think that they are a result of hypoxia because you don't discern evidence of hypoxia on the fetal monitor strips? A. There are abnormalities on the fetal monitoring strips. As I said before, I don't think they are associated with hypoxia. * * * Q. I understand your testimony to the contrary, but if -- if it turned out that after reviewing Samuel's fetal monitor strips you decided that there was evidence of hypoxia, would that be a reasonable link to the hemorrhage that was diagnosed? A. No, because Samuel didn't show any of the signs of hypoxia at birth so I don't believe he had any type of hypoxic damage. * * * Q. Do you not find any evidence at all of hypoxia on the fetal monitor strips? A. I believe the fetal monitoring strips indicate some fetal stress and that's all. Q. As opposed to distress? A. It just shows stress to the fetus during the inter-partum experience. That's all. Q. How do you define stress? A. I think the decelerations indicate, you know, stress on -- you know, stress is being placed on the fetus. Q. . . . [But] can't late decelerations be an indication of hypoxia? A. It's possible. Q. Could bradycardia in the 60 to 70 be[at]s per minute range be an indication of hypoxia? A. It's possible but not necessarily. * * * Q. . . . If you have an intraventricular hemorrhage that you attribute to a hypoxic ischemic insult that resulted during the course of labor and delivery and late in delivery, as has been suggested in this case, wouldn't you expect to see some clinically recognizable neurologic dysfunction in the neonate during the immediate newborn period? A. Yes, you would. Q. Even if the hemorrhage was, to use opposing counsel's words, isolated? A. Yes. If you're claiming that the neurologic problems are related to hypoxia, you would expect to see clinical signs of hypoxia at the time. Q. Even if the hemorrhage was isolated? A. Yes. Q. Can you explain that? A. You would see clinical manifestations in some way. You know, there would be some compromise in respiratory status, evidence of compromise in organ function because the lack of oxygen would affect not only the brain but other organ systems as well. You might see elevation of cardiac enzymes, liver enzymes, changes in renal function, changes in mental status, seizures, changes in blood pressure, respirations, etcetera. Q. And just so I'm clear, that is true even if the hemorrhage was isolated just within the ventricle? A. Yes, if you're attributing it to hypoxia. * * * Q. And based upon your review of the medical records, did you see any indication that Samuel had any such clinically recognizable neurological impairment or dysfunction during the immediate newborn period? A. No, I did not. Q. Did you note what his APGAR scores were? A. Yes, I believe he had normal APGAR scores. I believe they were eight and nine and one at five minutes. Q. Is that consistent with Samuel having suffered an isolated intraventricular hemorrhage that was the result of a hypoxic ischemic insult that occurred late in delivery -- A. No. Q. -- labor and delivery? A. I don't believe so. Q. Is the fact that there was no documented evidence of impaired neurologic function in Samuel during the immediate newborn period consistent with Samuel having suffered an isolated intraventricular hemorrhage that occurred late in labor and delivery? A. No. (Exhibit 29, pages 17, 18, 20-23, and 36-39). Here, there is no apparent reason to credit the testimony of Petitioners' witnesses on the issue of causation over the testimony of NICAs witnesses. Indeed, as among those who spoke to the issue of causation, Doctors Willis and Duchowny are the more qualified to address the issue, and their testimony the more persuasive.
The Issue The issues to be determined in this proceeding are whether Respondent, John L. Lentz, Jr., M.D., committed the disciplinary violations charged with respect to seven patients in three Administrative Complaints that have been consolidated for the purpose of hearing. If the facts demonstrate that any of the charged violations have been committed, then the appropriate penalty to be imposed for such violations must be recommended.
Findings Of Fact Based upon the testimony and documentary evidence presented at hearing, the demeanor and credibility of the witnesses, and on the entire record of this proceeding, the following findings of fact are made: Petitioner is the state agency charged with the licensing and regulation of the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to these proceedings, Respondent was a licensed physician in the State of Florida, having been issued license number ME 82437. Respondent’s address of record is 15200 Emerald Coast Parkway, St. Marten Unit 506, Destin, Florida 32541. Respondent was board-certified by the Academy of Family Physicians until 2009. He currently holds no board certification in any specialty area, and did not complete any residency other than his residency in family medicine. Respondent went to medical school at the University of South Carolina and initially practiced in that state. He moved to Florida in 2001 and since that time, has worked in a variety of practice settings, including working as an emergency room physician in several hospitals in areas such as Phenix City, Alabama; Panama City, Florida; and Defuniak Springs, Florida. At some point, Respondent became interested in the diagnosis and treatment of Lyme disease, and in approximately 2007, he opened a clinic in Destin named the Lentz Lyme Clinic. Respondent attended four continuing medical education courses that focused on the diagnosis and treatment of Lyme disease. Each of the courses he attended was three to four days long. Diagnosis and Treatment of Lyme Disease Lyme disease is an infectious disease caused by the bacteria Borrelia burgdorferi. Lyme disease is typically transmitted by a tick bite from what is often referred to as a deer tick, more formally known as the Ixodes scapularis tick. The tick is usually very small, and must remain on the person’s skin for approximately 36 hours or more in order for the disease to be transmitted. Lyme disease is generally considered to be endemic to the Northeastern United States, in states such as the New England states, Pennsylvania, upstate New York, Delaware, and northern Virginia. While it is not impossible to contract Lyme disease in Florida, the more persuasive evidence established that it is not prevalent in this state. The most credible, compelling evidence presented established that most people who are diagnosed in Florida with Lyme disease were most likely infected while traveling in a part of the country that is endemic for the disease, and that states in the Southeastern United States are in a low-risk area for Lyme disease. There was some conflict in the testimony concerning the stages and symptoms of Lyme disease, and what factors should be considered in diagnosing the disease at the various stages. The more credible and persuasive descriptions of Lyme disease and its stages describe the disease as having three stages: early localized Lyme disease; early disseminated Lyme disease; and late Lyme disease. The probable stage of the disease at the time a patient presents for diagnosis and treatment determines what is necessary for a diagnosis. Early localized Lyme disease is the disease as it typically presents within the first four weeks of the tick bite. The patient often, but not always, presents with a rash called an erythema migrans, which is generally over five centimeters wide (and can be as large as 19 centimeters) and is sometimes clear in the center, leading to the term “bull’s-eye rash” to describe it. In addition to the erythema migrans, a patient may present with virus-like symptoms, such as fatigue, malaise, fever, chills, myalgia (muscle aches), and/or headache. Often the symptoms at this stage, or any stage, for that matter, are non-specific symptoms that are common to a variety of conditions, including ALS and MS. According to Respondent’s expert, Dr. Cichon, these are conditions that a physician should also consider when diagnosing Lyme disease, Babesiosis, or Bartonellosis. In other words, when a patient presents with symptoms that do not include the erythema migrans, but are vague and non-specific, Lyme disease and co-infections related to Lyme disease should not be the only diagnoses considered. In order to diagnose Lyme disease a thorough history is required, including information on a patient’s travel locations, whether travel included states that are typically endemic for Lyme disease; the time of year the travel occurred; whether the patient engaged in the type of activity (such as hunting, fishing, hiking, or other outdoor activities) that would expose him or her to the possibility of a tick bite; any history of rashes; and whether the patient remembers a tick bite. The history should also include any symptoms the patient is experiencing and when the symptoms began. If the patient reports travel to an endemic area, and presents with an erythema migrans that the physician can examine, a diagnosis of early Lyme disease can be made without confirmatory laboratory tests. At that early stage, laboratory tests would not be particularly useful because they detect antibodies to the Borrelia burgdorferi, as opposed to detecting the bacteria itself. At that early stage of the disease, there is not sufficient time for the body to develop the antibodies necessary for detection through laboratory testing. The second stage of Lyme disease is called early disseminated Lyme disease, which may be characterized by multiple erythema migrans lesions; cardiac symptoms, such as atrioventricular block; arthralgia (joint pain); myalgia; or neurologic involvement, such as lymphocytic meningitis, facial nerve Palsy (Bell’s palsy), or encephalitis. If a patient presents with some combination of these symptoms, along with a history indicating travel to an endemic area and activities in that area consistent with tick exposure, a reasonable prudent physician would seek confirmatory laboratory tests to reach a diagnosis of Lyme disease, assuming the patient presents four weeks or more after possible exposure to a tick bite. The type of test to use is discussed below. Late Lyme disease is characterized by neurological symptoms, such as encephalomyelitis, peripheral neuropathy; and arthritis and arthralgia, usually in a single joint, such as a knee. As with early disseminated Lyme disease, a thorough history and physical is required for a diagnosis, as well as a confirmatory laboratory test. There was a great deal of testimony presented regarding the type of testing that is appropriate for the diagnosis of Lyme disease. Petitioner advocated the use of the ELISA test, followed by the Western blot test, commonly referred to as the two-tiered approach. ELISA and Western blot will be discussed in more detail below. Respondent contends that this two-tiered approach is inaccurate and that other tests are more definitive. His argument regarding the testing to use is consistent with his claim that there are two “standards of care,” one recognized by the Infectious Disease Society of America (IDSA), and one recognized by the International Lyme and Associated Diseases Society (ILADS). The tests recognized as standard for diagnosis of Lyme disease by Drs. Robbins, Anastasio, Robertson, Rosenstock, and Powers, are the two-tiered approach ELISA and Western blot tests. The ELISA is an enzyme-linked immunosorbent assay screening test. If the screening test is positive or equivocal for enzymes indicative of Lyme disease, a Lyme Western blot test is performed to confirm the presence of antibodies to Borrelia burgdorferi. For patients with early Lyme disease, the two-tier testing process may produce false negatives because the patient has not had sufficient time to develop antibodies in response to the bacteria. For those with late Lyme disease, the test is highly sensitive and specific because late Lyme disease patients have ample time to develop antibodies. The two-step approach is recommended by the Centers for Disease Control (CDC) because it provides for both sensitivity and specificity. Usually lab tests are either sensitive or specific, but not both. For a test to be considered “sensitive,” there are no false negatives. ELISA is considered a sensitive test. Specificity refers to the specific antibody bands being evaluated. With Western blot, there is an examination of different specific antibody bands. A Western blot IgM test looks for antibodies that are created initially from white blood cells that specifically attach to the infectious organism. A Western blot IgG looks for a different set of antibodies that continue to persist long after the infection is gone. A Western blot IgG is considered positive if five of the ten antibody bands are positive, while an IgM is considered positive if two of three bands are positive. The ILADS guidelines criticize use of the ELISA and Western blot tests because in the organization’s view, the two- tiered testing lacks sensitivity. The guidelines state that several studies “showed that sensitivity and specificity for both the IgM and IgG western blot range from 92 to 96% when only two [as opposed to five] specific bands are positive.”2/ While the ILADS guidelines criticize the two-tiered approach represented by ELISA and Western blot and indicate that other testing has been evaluated, “each has advantages and disadvantages in terms of convenience, cost, assay standardization, availability and reliability.” The ILADS guidelines do not expressly advocate not using the ELISA and Western blot, and note that while other tests remain an option to identify people “at high risk for persistent, recurrent, and refractory Lyme disease,” the tests have not been standardized. Dr. Michael Cichon, testifying for Respondent, opined that the ELISA and Western blot tests had little value and that Respondent’s failure to use them was not a departure from the standard of care. However, while at hearing he denied that he would order either test, in his deposition he indicated that he would order both tests, as a guide to diagnosis. His testimony that the ELISA and Western blot tests are not useful in the diagnosis of Lyme disease is rejected as not credible. Clear and convincing evidence at hearing established that a reasonable, prudent physician who is presented with a patient having possible exposure to Lyme disease occurring four weeks or more before seeing the physician would order the two- tier testing of ELISA and Western blot if it was appropriate to test for Lyme disease. While performing other tests in conjunction with the two-tier tests is not per se a departure, the standard of care requires either ordering the ELISA and where necessary, the Western blot, or reviewing any test results for these tests previously obtained by the patient. Treatment of Lyme disease also depends on the stage at which the condition is diagnosed. If a patient is diagnosed with early localized Lyme disease, a single course of doxycycline for 14 to 28 days is generally appropriate. Early disseminated Lyme disease and late Lyme disease may be treated with IV antibiotics, for a similar period of time. In summary, the standard of care in the diagnosis and treatment of Lyme disease requires a physician to take an appropriate medical history, perform a physical examination, obtain objective laboratory test results in the absence of an erythema migrans rash, and refer patients who do not improve after an initial course of antibiotic treatment to an infectious disease specialist for further evaluation. An appropriate history must include the information described in paragraph nine, and the testing to be ordered should include an ELISA and, where positive or equivocal, a Western blot test. Diagnosis and Treatment of Babesiosis Babesiosis is a parasitic disease of the blood caused by infection with Babesia. Babesiosis, like Lyme disease, is typically transmitted by a tick bite, and can be transmitted by the same tick that carries Lyme disease. There are occasions when a patient properly diagnosed with Lyme disease also will have Babesiosis as a co-infection. It is, however, not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Babesiosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. At all times material to the allegations in the Administrative Complaints, the standard of care for the diagnosis and treatment of Babesiosis included the physician taking an appropriate medical history, performing a physical examination of the patient, and obtaining objective laboratory test results in order to make an evidence-based diagnosis. As with Lyme disease, the patient’s medical history should contain information regarding the patient’s travel; whether they had exposure to a tick bite; whether they recall being bitten by a tick; as well as what symptoms the patient is experiencing. Babesiosis typically presents with virus-like symptoms, fever, sweats, and the identification of Babesia parasites in the patient’s blood. The tests that a reasonably prudent similar physician would order to determine whether a patient had Babesiosis are either a blood smear to identify Babesial parasites or a polymerase chain reaction (PCR) amplification of Babesial DNA. Should a patient be diagnosed with Babesiosis, the normal and customary treatment is a ten-day course of clindamycin and atovaquone. Diagnosis and Treatment of Bartonellosis Bartonellosis is an infectious disease caused by bacteria of the genus Bartonella. It is generally transmitted by lice or fleas on a person’s body, coming off of other animals, such as rats. It also can be transmitted through a cat scratch, as the cat gets fleas under its claws by scratching itself. As is the case with Babesiosis, a family practice physician is unlikely to diagnose Bartonellosis. It is not a common diagnosis, and even infectious disease specialists may go an entire career without diagnosing it. If a family practice physician suspects Bartonellosis, the better approach would be to refer the patient to an infectious disease specialist. However, failure to refer a patient to a specialist, assuming that the family physician performs the appropriate testing and treatment, is not necessarily a departure from the standard of care. In order to make a diagnosis, a thorough history and physical is required, along with objective laboratory test results. A physician should inquire about exposure to animals that could carry fleas, ticks, or lice, and whether there had been any recent instances where the patient has been scratched by a cat. The symptoms of Bartonellosis are nonspecific and include fever, headaches, myalgia, and arthralgia. The generally accepted test used to confirm a diagnosis of Bartonellosis would be a PCR amplification of Bartonella DNA, or paired blood serologies. DOAH Case No. 15-2888PL; DOH Case No. 2011-15106 (Patient C.C.) From approximately September 28, 2010, through approximately February 28, 2012, Respondent provided medical care and treatment to patient C.C. At the time of her original presentation to Respondent, C.C. was 27 years old. Prior to seeing Dr. Lentz, C.C. had a series of orthopedic injuries. For example, in 1998, C.C. was involved in a serious car accident, resulting in multiple broken bones and internal injuries requiring a two-week stay in the hospital. C.C. joined the Air Force in 2006, where she served as an aircraft mechanic. During basic training she suffered an injury to her shoulder, which caused problems with her neck, back, and shoulder. While in the military, C.C. was involved in two additional accidents: she broke her wrist in a motorcycle accident at some point, and on March 31, 2009, she had a second accident where the car she was driving was struck by another vehicle. While C.C. denied any injuries as a result of this second accident, shortly thereafter in July 2009, she had neck surgery because of discs impinging on the nerves in her neck. C.C.’s work as an aircraft mechanic required her to work in the fuel tanks of an airplane, which is a very confined space. C.C. is approximately 5’10” tall, and the work she performed required her to become contorted in a very small space for approximately 13 hours at a time. After her neck surgery, she started having increasing amounts of pain in her back and hips, to the point where she could no longer perform her job duties and in August of 2010, resorted to a wheelchair because of her inability to walk. Although she consulted multiple doctors both in the military and through referrals to outside physicians, she did not discover the cause of her pain. On or about September 28, 2010, Respondent evaluated C.C. for complaints of severe back, buttock, and right leg pain. When she presented for her first office visit, Dr. Lentz’s review of symptoms indicated that C.C. had a frontal headache with pain at a level of 10 out of 10; sensitivity to light and sound; loss of hearing and buzzing; nausea but no vomiting; withdrawal symptoms described as sweats when she did not take Ultram or Lortab; and feelings of hopelessness and emotional lability. His physical examination reported that C.C. was in a wheelchair, and documented “soles of feet painful, SKIN: rashes, soles of feet red, NEURO: paresthesia, pain, tender extremity.” At that time, Respondent diagnosed C.C. as having chronic fatigue syndrome and chronic pain syndrome. In C.C.’s history, Respondent noted that she “grew up in Texas/Arkansas-hunting, forests, etc. There is no notation of recent travel on this first visit. Dr. Lentz asked her about any flu-like symptoms, which she denied having. Many of the symptoms listed by C.C. are general symptoms that are common to a variety of ailments. Respondent, however, focused only on chronic fatigue, chronic pain, Lyme disease, Babesiosis, and lupus. On this first office visit, Respondent prescribed CD57, C3a, C4a, and eosinophilic cationic protein (ECP) laboratory tests of C.C.’s blood. With respect to the order for CD57, Respondent listed Lyme disease as a diagnosis. For the C4a and C3a, he listed Lyme disease and Lupus as the diagnoses, and for the ECP he listed a diagnosis of Babesia infection. Respondent did not prescribe an immunoassay (ELISA) test or Western blot test for Borrelia burgdorferi for C.C. The ECP test result for C.C. collected on October 6, 2010, was 20.8. The reference range for a normal test result is 1-10. The notation for the test on the lab result states: This test uses a kit/reagent designated by the manufacturer as for research use, not for clinical use. The performance characteristics of this test have been validated by Advanced Diagnostic Laboratories at National Jewish Health. It has not been cleared or approved by the US Food and Drug Administration. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. On or about October 15, 2010, Respondent diagnosed C.C. with Lyme disease. He based his diagnosis of Lyme disease on the results of the CD57 blood test. The CD57 test is a cluster designation test that measures a marker found on lymphocytes, which are a type of white blood cell that are sometimes referred to as natural killer cells. Although Respondent claimed at hearing that he did not consider the test to be definitive, in his deposition he indicated that he believed that it was in fact definitive. Dr. Cichon, on the other hand, testified that the CD57 test used by Dr. Lentz is not a definitive test for Lyme disease, but is useful for measuring the progress of treatment. At least one test result for C.C. reflecting the results for a CD57 panel has the following notation from the laboratory: This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure. On or about October 15, 2010, Respondent also diagnosed C.C. with Babesiosis. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.C. He based his diagnosis on the ECP test. On October 15, 2010, Dr. Lentz received an e-mail from C.C.’s roommate, M.B., informing him that C.C. had visited the emergency room over the weekend because of the level of her pain. The e-mail asked whether C.C. could begin with her treatment before her next appointment. In response, Dr. Lentz called in prescriptions for doxycycline and Cleocin, both of which are oral antibiotics. On or about October 18, 2010, Respondent described C.C. as being in no acute distress, with a gait that is within normal limits. He also noted some wheezing, pain all over, tears, and cramps in her muscles. Respondent prescribed long-term IV antibiotic therapy and referred C.C. to a specialist for venous port placement for the administration of intravenous (IV) antibiotic therapy. The specific medications prescribed at this visit are acetaminophen-oxycodone 300 mg - 7.5 mg oral tablets to be taken three times daily; Cymbalta 30 mg oral, once a day; Flagyl 500 mg oral tablets, to be taken three weeks on, one week off; heparin 5000 units/ml injectable solution, once a day; Omnicef 300 mg oral capsules, once a day; Interfase Plus Prothera, a supplement; and boluoke lumbrokinase, also a supplement. At the October 18, 2010, visit, he also ordered a Fry test for Bartonellosis and prescribed intravenous vancomycin, with weekly vancomycin trough levels. Dr. Lentz testified at hearing that the prescription for vancomycin was to treat Bartonellosis.3/ However, at this juncture, no diagnosis for Bartonellosis had been made. Heparin is an anticoagulant that is used for a variety of issues, such as blood clots, pulmonary emboli, and Berko emboli. It is also used in coronary heart disease if a patient has a myocardial infarction. The more persuasive and credible testimony established that it was below the standard of care to use heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis. Not only did heparin have no efficacy, it had the potential to be very dangerous for C.C., or any other patient. On October 28, 2010, Respondent noted that the vancomycin was at 1.5 grams and still not therapeutic, and ordered that the medication be changed to Primaxin and that the Omnicef and vancomycin troughs be stopped. On November 10, 2010, Respondent noted that C.C. was experiencing flu-like symptoms, but was now resting fewer hours each day. For the first time, he noted “past 4 years in military=Virginia, Canada, Honduras, as sites for exposure to Lyme.” He also noted “no wheelchair, but slow to move, pain to rt LS-hip-leg.” He continued to list her diagnoses as Lyme disease, Babesiosis, chronic pain syndrome, and chronic fatigue syndrome. Respondent also saw C.C. in the office on December 8, 2010, and January 10, 2011. At the December 8, 2010, visit, he discontinued the use of Flagyl because of her nausea and switched to Tindamax (one tablet daily for three weeks, then off one week) instead. On January 19, 2011, Dr. Lentz received an e-mail from C.C.’s roommate regarding a fall C.C. had over the weekend. As a result, he wrote an e-mail to C.C. and told her to stop the Tindamax and “add the neurotoxins to remove the neurologic toxins that are being created by the antibiotics.” He also directed her to stop the heparin injections, as she needed to be off of heparin before having some hand surgery to remove a cyst. C.C. returned for an office visit on February 9, 2011. At that time, Respondent’s notes indicate that she was ambulatory but still significantly fatigued and still falling. He noted, “rt hip. sciatic nerve still #1 symptom, can not stand or walk for long periods of time, not sure if neurologic/Lyme or degenerative nerve dis.” In his assessment, he stated she “needs CT lumbar sacrum to r/o orthopedic issue with back pain.” During the course of treatment, Respondent was consistently prescribing OxyContin at 10 mg, three times daily. On March 16, 2011, he referred C.C. to Dr. Beach at Andrews Institute to detox off the OxyContin. He also noted that she had been given 100 percent disability through the military, and would take approximately four months to process out of the military. He also noted “electrical ablation at T9, T10 for chronic back pain per Dr. Nyguen.” Dr. Lentz continued to see C.C. on April 12, 2011; May 4, 2011; and May 13, 2011. Throughout her treatment with IV antibiotics, C.C. experienced problems with nausea, rashes, and diarrhea, but claims that over time, her symptoms began to improve so that she could walk and eventually was able to hold down part-time employment. Toward the end of her military tenure, C.C. needed a referral in order to continue to see Dr. Lentz. To that end, on June 8, 2011, she saw Dr. Janelle Robertson, M.D., a board certified infectious disease specialist at Eglin Air Force Base. Dr. Robertson evaluated C.C. for Lyme disease, and documented her history, including travel history and history of tick bites. She reviewed prior records from Eglin Air Force base that indicated C.C. had an ELISA screening on June 10, 2010 (approximately two and a half months before seeing Dr. Lentz), that was negative. The ELISA test was not only performed before C.C. saw Dr. Lentz, but well after C.C. began suffering the symptoms that led her to seek out Dr. Lentz. Accordingly, the ELISA test was administered at a time at which C.C. would have developed sufficient antibodies for the test to be useful. Dr. Robertson also noted that while C.C. had a history of tick bites in Florida, Texas, and Alabama, she did not report any rashes or illness at or near the time of the tick bites. She also had no history of migratory arthralgia or Bell’s palsy. Dr. Robertson testified credibly that C.C. was having no night sweats, weight loss, changes in vision, palpitations, difficulty breathing, or gastrointestinal problems, and that her primary complaint was back and hip pain. C.C.’s pain remained in the same locations and persisted without resolution since 2009. Dr. Robertson concluded that C.C. did not have Lyme disease, and that her prior negative ELISA test conclusively established that she did not have the disease. She opined that, given that C.C.’s symptoms had persisted since 2009, if she had actually had Lyme disease, she would have developed antibodies that would have been detected with the ELISA test. She also determined that Respondent did not have Babesiosis and recommended to C.C. that she immediately stop the therapy prescribed by Dr. Lentz, because in Dr. Robertson’s view, the therapy was unsafe. C.C. has since transitioned out of the military into civilian life. Although she believes that the treatment by Dr. Lentz was effective in treating her condition, the events since she stopped treatment for Lyme disease suggest otherwise. For example, C.C. testified in her deposition that her treatment ended in mid-May 2011 because Dr. Lentz determined that she did not need more treatment, yet it appears that the military would no longer authorize treatment by Dr. Lentz once C.C. saw Dr. Robertson. Moreover, she continues to have some of the same pain that led her to treatment with Dr. Lentz. In approximately October 2014, she had hip surgery because her “hips are pretty much shot.” She has had three surgeries for kidney stones, steroid injections for temporary relief from her back pain, and acupuncture treatments for her back pain. At least one physician attributed her problem to the kind of work she performed as an aircraft mechanic, and at deposition she indicated that a recent MRI indicated that she has some lumbar narrowing. In short, it appears that the months-long IV antibiotic therapy she endured has provided no lasting solution to her pain. Respondent’s care and treatment of C.C. was a departure from the standard of care in that he diagnosed Lyme disease based upon an inadequate history and no objective laboratory test results from an ELISA test and Western blot. Specifically, Respondent failed to obtain C.C.’s travel history or any history of rashes, possible tick bites, including the size of the tick, and in fact obtained a history devoid of any flu-like symptoms characteristic of Lyme disease. C.C.’s primary symptoms were related to her back pain. Respondent’s own expert, Dr. Cichon, testified that the key to a diagnosis of Lyme disease is the patient’s history.4/ With this inadequate history in mind, Respondent did not obtain an ELISA test or Western blot, but instead relied on a test that, on its face, indicates that it is for investigational use only and should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically-established diagnostic product or procedure. The more persuasive and compelling testimony established that the failure to obtain objective laboratory confirmation of Lyme disease through the use of the ELISA and Western blot tests is a departure from the standard of care recognized by a reasonably prudent similar physician. The more persuasive and compelling evidence also established that C.C. did not actually have Lyme disease, despite Respondent’s diagnosis of the disease. Respondent also departed from the appropriate standard of care by his failure to use the appropriate tests for the diagnoses of Babesiosis and Bartonellosis. His test of preference, the ECP test, is by its own terms, not intended to be used as the sole means for clinical diagnosis or patient management decisions. As stated by Dr. Robbins, it has no clinical relevance and is diagnostic of nothing. Likewise, his credible testimony indicated that use of the Fry test was not appropriate, as it is a proprietary test of the laboratory and not FDA approved.5/ Respondent’s care and treatment of C.C. also departed from the applicable standard of care by prescribing surgery for placement of a venous port for administration of intravenous medication, and by prescribing both intravenous and oral antibiotic therapy in inappropriate and excessive amounts. The more credible and persuasive testimony demonstrated that C.C. did not have Lyme disease, Babesiosis, or Bartonellosis, and therefore did not need any of the antibiotic therapy prescribed. Even had C.C. received a correct diagnosis, the more persuasive evidence demonstrated that the amounts and duration of the antibiotics prescribed were not only unwarranted, but potentially dangerous for the patient. C.C. had the possibility of negative reactions from the many antibiotics prescribed, but also the very real possibility that she has built up a resistance to the antibiotics such that they will be ineffective should she actually need them in the future. Finally, Respondent’s care and treatment of C.C. departed from the applicable standard of care by the prescription of heparin. There was no medical justification for the prescription of an anticoagulant for the treatment of Lyme disease, even if appropriately diagnosed (which did not happen here), and as with the prescription of multiple long-term antibiotics, was potentially dangerous and harmful to the patient. DOAH Case No. 15-2889PL; DOH Case No. 2011-18613 (Patients D.H., S.L., J.L., W.L., and D.D.) Patient D.H. Respondent provided care and treatment to patient D.H. from approximately November 24, 2010, to approximately October 14, 2011. D.H. was previously seen by a physician’s assistant, Thomas Gregory Roberts, who at various times worked under Respondent’s supervision, including the period from April 29, 2009, to May 26, 2010, and again from September 21, 2010, through December 18, 2010.6/ Mr. Roberts had ordered a previous CD57 test for D.H., and had prescribed doxycycline for him on a long-term basis. Mr. Roberts’ office was closing and his records were no longer available, so on November 24, 2010, D.H.’s wife, J.H., e-mailed Dr. Lentz to request laboratory tests and to schedule an appointment for D.H. She stated in part: Dear Dr. Lentz: Both my husband and I have been to you before, but not at your current office. [D.H.] went to Tom Roberts at Village Health Assoc. and was sent for blood work. His CD57 counts were off, so he put him on Doxycycline [sic] and was on it for several months. His last blood work was done in July and by the sound of it showed some improvement, but he told him to stay on the antibiotics. Tom Roberts gave him an order for follow up bloodwork which reads CD57 + NK Cells Dx2793. Since he is currently not practicing that we know of, we are requesting that you please write an order so that [D.H.] can have blood work done and come to you for the results. Based upon this e-mail, Respondent ordered a CD57 test, using the diagnostic code for and reference to Lyme infection, and an ECP test using the diagnostic code for and reference to Babesia infection. He did so without actually seeing D.H., taking a history, or performing a physical examination. Respondent diagnosed D.H. as having Lyme disease and Babesiosis. He communicated the diagnoses to D.H. on December 25, 2010, via e-mail, stating, “CD57 is positive for Lyme and ECP positive for Babesia. Call Amy at 424-6841 for an appointment. Dr. Lentz.” It does not appear from the record that he considered or ruled out any other condition for D.H.’s complaints. Respondent did not prescribe or order for D.H. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests at any time during D.H.’s care and treatment. Respondent did not refer D.H. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis at any time during Respondent’s treatment and care of D.H. D.H.’s first office visit was January 17, 2011. At that time, J.H., D.H.’s wife, who attended the majority of his doctor’s visits with him, testified that his only complaint at that point was fatigue, and ongoing diarrhea she attributed to the lengthy time he had already been on antibiotics. She acknowledged that he checked off those items on a form at the doctor’s office, but was not going to see Dr. Lentz complaining about those: he went simply because of his fatigue. He had no rash at that point, and never complained of a tick bite. Dr. Lentz’s records, however, indicate that he complained about exhaustion; face-neck, jaw, and orbital pain; diarrhea; cramping; stiff and painful joints; mood swings; irritability; explosive [sic]; and poor concentration. From what J.H. could remember, the physical examination Respondent performed on D.H. was very brief. Respondent took D.H.’s blood pressure, possibly looked in his mouth, palpated his abdomen, and did a knee reflex test. She did not remember him doing anything else, except having D.H. fill out a long form. Dr. Lentz’s medical records for this visit contain no prior medical history, no pulse, and no respiration rate. Respondent diagnosed D.H. with Lyme disease. When J.H. asked him if he was sure, Respondent said, absolutely. J.H. had done some research and knew that Respondent had only ordered a CD57 for D.H. She asked him about ordering the Western blot, but he did not order it. She could not remember Respondent’s exact response, but was led to believe that he did not think that the Western blot test was as accurate in diagnosing Lyme disease. At this first visit, Respondent also ordered the Fry test. Results from the Fry test are dated January 25, 2011, and indicate: Based on the accompanying test results for the sample for listed patient and accession number is suggested for follow up confirmation of the putative organism(s). Protozoan: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of a protozoan. PCR testing for putative FL1953 is suggested for follow-up confirmation. EPierythrozoan/Hemorbartonella: The Special Stains (100x magnification) or the Advanced Stains (magnification listed) for this sample is suggestive of epierythrozoan/ hemobartonella. PCR or serology testing for the putative epierythrozoan/hemobartonella (Bartonella spp.) is suggested for follow up confirmation and speciation. (emphasis added). The records do not indicate that Respondent ordered any of the follow-up testing recommended by the Fry laboratory which, ironically, is the very testing for Bartonellosis that a reasonably prudent similar physician should order for this condition. His records also do not indicate that he ever added Bartonellosis as a diagnosis for D.H. During the course of his treatment, Respondent prescribed for D.H. the antibiotics Omnicef, azithromycin, and Cleocin, as well as Interface Plus Prothera (an enzyme supplement formulation), boluoke lumbrokinase (a fibrinolytic supplement), atenolol (a beta blocker used primarily in cardiovascular disease, added March 7, 2011), heparin injections (an anticoagulant, also added March 7), artemisinin (an antimalarial, added June 14), Mepron (an antiparasitic, added June 14), Tindamax (added June 14), Plaquenil (an antimalarial), and Vermox (an anthelmintic)(both added August 21). J.H. understood that, based upon Respondent’s explanations, the heparin was prescribed to help other medicines be absorbed into the cells, or something along those lines. She was concerned about D.H. being on the heparin, in part because as a result of him injecting the heparin in his abdomen, D.H. had a lot of bruising and knots all over his belly. She was also concerned because D.H. worked as a boat captain on the Mississippi River, which required him to be away from home for weeks at a time. She was concerned about the ramifications should he have an accident at work when he had no access to medical care. Her concerns were warranted. The couple also had concerns about the number of medications D.H. was taking while under Respondent’s care. He developed blurred vision, did not sleep well, and had chronic diarrhea. When D.H. came home from his last visit, which J.H. apparently did not attend, he reported that Dr. Lentz had said something about having a port placed for the administration of more antibiotics. That shocked her, so before he would go through with port placement, they sought a second opinion. Dr. Patrick Anastasio is an osteopathic physician who is a board-certified infectious disease specialist. During all times relevant to these proceedings, he was a solo practitioner in private practice at Emerald Coast Infectious Diseases in Fort Walton Beach, Florida. He has worked in the area for approximately 12 years. D.H. sought a second opinion from Dr. Anastasio regarding his Lyme disease and Babesiosis diagnoses. To that end, he saw Dr. Anastasio for the first time on September 29, 2011. Dr. Anastasio did not believe that D.H. had the symptoms initially to place him in a high risk group for Lyme disease. During his examination, he looked for signs that would be consistent with Lyme disease, such as arthritis, cognitive problems, or neurological problems, but did not discover any. Dr. Anastasio did not believe that D.H. had either Lyme disease or Babesiosis, but ordered a blood smear, and a Western blot and a Babesia PCR test to rule out the conditions. All tests came back negative.7/ Dr. Anastasio recommended to D.H. that he stop taking all of the medications prescribed by Dr. Lentz, and D.H. did so. It still took months for the diarrhea, most likely caused by the long-term antibiotic therapy, to subside. However, D.H. began to feel better once he stopped taking the antibiotics. Dr. Charles Powers, M.D., testified that Dr. Lentz’s medical records for D.H. were not adequate for the evaluation of whether D.H. had Lyme disease. He also believed that it was below the standard of care to use the CD57 for the diagnosis of Lyme disease as opposed to the ELISA and Western blot tests, and that it was below the standard of care not to order the ELISA and Western blot tests in the absence of an erythema migrans rash that Dr. Lentz could physically observe. Dr. Powers believed that there was no basis upon which to diagnose D.H. with Lyme disease, and therefore any treatment based on this faulty diagnosis would be below the standard of care. Even assuming the diagnosis was correct, Dr. Powers opined that the treatment ordered also was below the standard of care. According to Dr. Powers, a reasonably prudent family practitioner would usually prescribe doxycycline for the majority of cases, as opposed to the regimen of medications used by Dr. Lentz. Prescribing antibiotics the way they were prescribed would include adverse side effects, such as nausea and/or diarrhea with resistance to bacteria; development of C. difficile infection, which can be difficult to treat; and potential for allergic reactions, which can be fatal. Dr. Powers testified that when a combination of antibiotics is being used, with each additional antibiotic prescribed, the risk for complications increases exponentially. His testimony is credited. Dr. Powers also opined that the use of heparin in the treatment of Lyme disease, Babesiosis, or Bartonellosis was a departure from the standard of care, and was a dangerous choice for this or any other patient who did not have a need for a blood thinner. Dr. Robbins also believed that Respondent’s care and treatment of D.H. was below the standard of care. He testified that Respondent breached the standard of care by diagnosing D.H. with Babesiosis using the ECP test and the Fry testing for the purpose of diagnosing Bartonellosis. He also testified, consistent with Dr. Powers, that using heparin in the treatment of any of these three diseases was an egregious departure from the standard of care. The testimony of Drs. Robbins and Powers is credited. Dr. Cichon expressed concerns about the amount of medications prescribed by Dr. Lentz to D.H., specifically singling out the prescriptions for Plaquenil and Vermox. While his testimony fell far short of declaring that prescribing these medications represented a departure from the standard of care, his testimony was certainly not a ringing endorsement. It seemed as if he was trying to convince himself that Respondent’s care and treatment of this patient fell within the standard of care. His testimony to that effect is rejected as not credible. D.H. did not have a medical condition that justified the prescription of any of the medications and supplements that Dr. Lentz prescribed, much less for the duration taken. The prescription of any of these medications without a valid diagnosis was a departure from the standard of care attributed to a reasonably prudent similar physician. Patient S.L. Respondent provided care and treatment to patient S.L. from on or about August 17, 2010, to on or about January 7, 2011. On or about August 17, 2010, at her first office visit with Dr. Lentz, S.L. presented with and reported to Respondent a history of heavy rectal bleeding, which occurred every four to five days. At that visit, S.L. informed Respondent that in June, she had been advised to get a colonoscopy. Because of economic constraints, S.L. did not obtain the requested colonoscopy. There is no indication in the patient records for S.L.’s first office visit (or any later visit) that the reason for S.L.’s bleeding prior to his treatment of her had been determined or that it had resolved. S.L. first went to see Dr. Lentz at Hope Medical Clinic8/ because she believed that she had a urinary tract infection. She also had severe back pain, with pins and needles down both legs. Her back pain had started in 2005, following a car accident. S.L. does not recall Respondent ever performing a physical examination, although the patient records indicate that at least a minimal examination was performed. She does recall him talking to her about being from Pennsylvania, but does not recall him asking her about any travel history, whether she had been exposed to ticks, or had ever been bitten by a tick. Dr. Lentz’s medical records for this first visit make no mention of a travel history; no mention of tick exposure; and no mention of any type of rash. Much of the history related to other issues, such as S.L.’s history of bleeding, as opposed to any symptoms that could be said to be indicative of Lyme disease. The symptoms documented are “paresthesis to both legs due to lumbar path. Recent hematochezia. No melena. No upper abd. Pain. No diarrhea. Mostly awake sxs, not hs.” Yet in his assessment/plan notes, he lists diagnoses of lumbago, displacement of lumbar intervertebral disc without myelopathy, and chronic pain syndrome. He prescribed Lyrica, Elavil, Lortab, and ordered a CD57, listing the Lyme disease diagnostic code. There was no medical basis, based on the history presented, to suspect or test for Lyme disease. On September 21, 2010, S.L. presented to Dr. Lentz for a follow-up appointment. At this appointment, Respondent diagnosed S.L. as having Lyme disease. He ordered a Fry Bartonella test as well as an ECP test, and prescribed doxycycline, Omnicef, and Flagyl. On September 30, 2010, S.L. called Respondent and reported throwing up all of her antibiotics, and asked about medication for her nausea. Dr. Lentz added the diagnosis of Bartonellosis without seeing S.L. or performing any further physical examination. The results of the Fry test in the patient records state: “rare (1-4 organisms per total fields observed) coccobacilli adherent to erythrocytes – indicated by yellow arrow(s). This is suggestive of Hemobartonella(1) or Hemoplasma(2).” The notes also state, “[t]his stain is not FDA approved and is for research only.” At S.L.’s next appointment on October 5, 2010, Dr. Lentz prescribed rifampin and Cleocin, as well as Lovenox injections. Lovenox is a low molecular weight heparin that can be given subcutaneously. At the time Dr. Lentz prescribed it, there was no determination regarding the cause of her heavy rectal bleeding just a few months before. On October 19, 2010, just two weeks after starting the Lovenox injections, S.L. presented to the emergency room at Sacred Heart Hospital with complaints of blood in her urine.9/ Physicians in the emergency room attributed the blood in her urine to the Lovenox injections, and discharged her with a diagnosis of hematuria. That same day, she presented to Dr. Lentz and told him about her emergency room visit. Dr. Lentz lowered the dose for Lovenox, but did not discontinue its use. His notes for this visit indicate that she had left flank pain, slight liver tenderness, no masses, and a “light liver test elevated, <2X normal.”10/ He added a diagnosis for Babesiosis, but did not appear to explore what was causing the liver tenderness and elevated tests. Under his assessment and plan, it states: “1. Cut Lovenox BID to QAM. 2. Add Culturelle/probiotics to GI tract due to antibiotics being used, if urine lightens up and less blood on dipstick, then improvement.” Respondent did not prescribe S.L. a PCR amplification or Bartonella or Babesial DNA, or Western blot immunoassay tests at any time during Respondent’s care and treatment of S.L. Respondent did not refer patient S.L. to a specialist in the diagnosis and treatment of infectious diseases, such as Lyme disease, Bartonellosis, and Babesiosis, at any time during Respondent’s care and treatment of S.L. S.L. testified that the physicians at Sacred Heart Hospital informed her that there was no reason for her to be on the antibiotics or blood thinner prescribed by Dr. Lentz, and based upon their advice, she stopped the medication regimen he prescribed. The medical records from Sacred Heart do not mention this advice, and she saw Dr. Lentz at least twice after her emergency room visit: October 19 and November 2, 2010. After that, the only communications in Dr. Lentz’s medical records for S.L. appear to be requests for medication related to urinary tract infections as opposed to treatment for Lyme disease, Babesiosis, or Bartonellosis. In any event, she quit seeing Dr. Lentz for Lyme disease, Babesiosis, and Bartonellosis at least as of November 2, and testified credibly that she feels fine. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz’s diagnosis and treatment of S.L. violated the applicable standard of care in that he failed to obtain an appropriate history to diagnose Lyme disease, Babesiosis or Bartonellosis in the first place. He failed to obtain a travel history, any information regarding possible tick bites, and if there was such a bite, the size of the tick and duration of the bite. He also failed to document symptoms that would suggest the possibility of Lyme disease to justify any objective laboratory testing. S.L.’s symptoms were related to back pain and a history of heavy bleeding. Her symptoms simply did not justify testing for Lyme disease. The evidence was not clear and convincing that Respondent failed to perform an adequate examination. As noted above, while S.L. does not remember one, the medical records reflect notations indicating that one was in fact performed. The problem is that the history and physical examination do not support further investigation for Lyme disease. Respondent also departed from the applicable standard of care by relying on tests that were not appropriate for the diagnosis of Lyme disease, Babesiosis, or Bartonellosis. As stated above, there was no basis to test for these conditions at all, but if testing was going to be performed, then the appropriate tests were not the CD57, ECP, and Fry tests, but rather the ELISA, Western blot, PCR, and serologies discussed above. Respondent’s prescription of multiple antibiotics of lengthy duration also violated the standard of care, for reasons discussed above at paragraphs 60 and 79. Likewise, Respondent’s prescription of Lovenox fell below the standard of care. The use of Lovenox for Lyme disease, Babesiosis, and Bartonellosis is not warranted at all, but is especially egregious here, where S.L. had excessive bleeding problems of which Respondent was aware just months before Lovenox was prescribed, with no documentation that the cause of the bleeding had been identified and addressed, and no indication that Respondent did anything to investigate the cause of the bleeding. That he continued to prescribe the Lovenox, albeit at a lower dose, after her visit to the emergency room with hematuria, just compounds the problem. Dr. Cichon testified that Respondent met the standard of care in diagnosing and treating S.L., saying that she had unexplained pain that could be due to Lyme disease. He struggled to identify any symptoms that are commonly associated with Lyme disease. His testimony seemed to indicate anytime there is unexplained pain, Lyme disease is a possibility. His testimony on this issue is not credible. The same can be said for his support of the diagnosis of Babesiosis. Dr. Cichon identified the primary symptoms of Babesiosis as headaches, sweating, and air hunger. S.L. did not have these symptoms, leaving only the ECP test as a basis for diagnosis. Relying on the ECP (which is only slightly elevated) is contrary to Dr. Cichon’s own testimony regarding the primary importance of a thorough history to support such a diagnosis. Similarly, Dr. Cichon acknowledged in his testimony that he could not tell from Respondent’s medical records whether S.L. had any symptoms to support a diagnosis for Bartonellosis, and stated that her symptoms could be due to her lumbar pathology. Given these inconsistencies, his opinion that Dr. Lentz did not depart from the applicable standard of care in the diagnosis of each of these diseases is not credible and is rejected. Medical records must justify the course of treatment for a patient. Dr. Lentz’s medical records for S.L. do not justify the diagnosis or treatment of Lyme disease, Babesiosis, or Bartonellosis. The medical records do not document symptoms that are consistent with the diagnoses of any of these diseases, and fail to provide a complete medical history. Patients J.L., W.L., and D.D. J.L. is the mother of S.L. W.L. is J.L.’s husband and S.L.’s father, and D.D. is S.L.’s son and J.L. and W.L.’s grandson. On September 22, 2010, approximately one month after S.L. began treatment with Dr. Lentz, J.L. wrote him the following e-mail: Dr. Lentz: Thank you for talking with me on the phone today. We are really concerned about S.L. and we can not [sic] express to you how much you are appreciated for all you have done for her. You are a true blessing to our family. My husband was bitten by a tick over the July 4th weekend in MO. He developed the bulleye [sic] rash and went to our family doctor. Dr. Calvin Blount. He was give [sic] 10 days of antibiotics, but no follow up or blood test were ever ordered. We would like to be tested for Lyme. We believe that S.L. might have contracted Lyme before she became pregnant with D.D. and would like him tested also. Here is our information. Please let me know if you need any additional information. Thank you again for all you have done. As noted above, there was an insufficient basis to justify the ordering of any tests related to Lyme disease for S.L. The only basis for ordering tests for D.D. is the suspicion that S.L. may have been infected prior to giving birth to D.D. If there is no basis for suspecting S.L. has Lyme disease, there is no basis for suspecting D.D. has Lyme disease. Respondent did not make an appointment for, take a history from, or perform a physical examination of J.L., W.L., or D.D. Based upon this e-mail alone, he ordered CD57 and ECP tests for all three of them, as well as C4a and C3a tests for J.L. and W.L. To justify ordering the tests, he listed “Lyme Disease (088.81)” under his assessment/plan for each patient. Although he never saw any of these patients, he coded each encounter as “high complexity.” On October 14, 2010, Dr. Lentz sent an e-mail to J.L. stating that “D.D. is positive for Lyme and negative for Babesia.” On October 24, 2010, Dr. Lentz sent an e-mail to J.L. stating, “W.L. C4A is back=20,000+ indicative of active Lyme.” On October 25, 2010, Dr. Lentz sent an e-mail to J.L. which stated, “[t]he CD57 is 50=positive, and the ECP is 11.5=positive for Babesia. My initial charge is $400 and $200 for return visits. Since I will be seeing both you and [W.L.], I will drop that to $300 initial visits. Call Amy for the schedule.” Dr. Lentz testified that he did not diagnose J.L., W.L., or D.D. with any condition, and did not really consider them to be patients. In his view, he was simply doing a favor for the family members of a patient. However, he created records that referred to each patient as being new patients needing tests for Lyme disease, and included diagnostic codes for the lab tests. With respect to each of them, he made an interpretation of the tests that he ordered. At least with respect to D.D., he admitted in his deposition that he diagnosed D.D. with Lyme disease based on the laboratory tests. Both S.L. and W.L. testified credibly that, based on the communications received from Dr. Lentz, they each believed that he had diagnosed them with Lyme disease, and that he had diagnosed J.L. with Babesia. It is found that he did, in fact, provide diagnoses to J.L., W.L., and D.D., without the benefit of a personal history, or a physical examination. Respondent did not refer J.L., W.L., or D.D. to a specialist in the diagnosis and treatment of infectious diseases such as Lyme disease, Bartonellosis, or Babesiosis. Respondent did not order for J.L., W.L., or D.D. an ELISA or Western blot test, PCR amplification of Bartonella or Babesial DNA, or blood smear tests. J.L. and W.L. decided to get a second opinion regarding the Lyme disease and Babesiosis diagnoses, and went to see Dr. Anastasio. Dr. Anastasio testified that J.L. did not have the required exposure to or symptoms for Lyme disease. Because she came to him with a Lyme disease diagnosis, he ordered a Lyme Western blot, a PCR for Babesiosis, and a PCR for Bartonellosis. J.L.’s Western blot IgM was negative, with two of the three antibody bands tested returning as absent. The Western blot IgG was negative, with all ten antibody bands returning as absent. J.L.’s PCRs for both Babesiosis and Bartonellosis were negative. Dr. Anastasio testified that he did not believe that J.L. had either Lyme disease or Babesia. His testimony was persuasive, and is credited. Dr. Anastasio testified that, given W.L.’s history of a tick bite followed by a rash, there was at least a basis to believe his symptoms could be an indication of Lyme disease. The tick bite and rash were approximately six months prior to W.L. presenting to Dr. Anastasio, and almost three months prior to Dr. Lentz ordering tests for him. Given these time frames, there was plenty of time for W.L. to develop antibodies to Lyme disease if he was in fact infected with the disease. Dr. Anastasio testified that at the time he saw W.L., W.L.’s symptoms were not consistent with late Lyme disease. Dr. Anastasio ordered several tests for W.L., including a Lyme Western blot, a PCR for Babesiosis, a blood smear for Babesiosis, and a PCR for Bartonellosis. The Western blot test was negative, with zero out of ten antibodies present. Both PCR tests and the blood smear were also negative. Dr. Anastasio concluded that W.L. did not have Lyme disease, Babesiosis, or Bartonellosis, and his testimony to that effect is credited.11/ Respondent failed to meet the applicable standard of care with respect to the care and treatment of patients W.L., J.L., and D.D. Based on the credible testimony of Drs. Powers and Robbins, Dr. Lentz departed from the standard of care in ordering tests for all three patients when he did so without seeing them, taking a history with respect to any of them, or conducting a physical examination of any of them to determine whether any of the requested tests were warranted or even justified. Respondent also departed from the applicable standard of care when he ordered tests that would not even assist in diagnosing Lyme disease, Babesiosis, or Bartonellosis had testing for those conditions been appropriate. Moreover, Dr. Powers testified credibly that the appropriate way to order tests for a suspected condition is to use the symptoms that are being investigated by the physician ordering the test, as opposed to the suspected disease being considered. For example, one ordering a mammogram would list “screening” or “diagnostic,” not “breast cancer,” because at that point, breast cancer has not been, and might never be, diagnosed. Documenting the symptom as opposed to the disease is important in terms of continuing care, so that there is no confusion by a subsequent health care provider reading the records about a premature diagnosis. Dr. Powers’ testimony is credited. Dr. Lentz also claimed that because J.L., W.L., and D.D. were not his patients, he did not need to have medical records for them that complied with section 458.331(1)(n). However, Dr. Lentz created patient records for all three in order to order the laboratory tests for them. He coded the action taken as having high complexity. The definition of medicine includes “diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition.” § 458.305(3), Fla. Stat. Respondent clearly engaged in the practice of medicine when he wrote prescriptions for tests for the purpose of diagnosing disease. By ordering these tests, creating medical charts for them (however limited they may be), interpreting the test results and communicating those results, he established a physician-patient relationship with J.L., W.L., and D.D. Accordingly, he was required to have patient records that justified the course of treatment (here, the diagnosis of Lyme disease, Babesiosis, and Bartonella). The records presented do not meet that requirement. DOAH Case No. 15-2890PL; DOH Case No. 2012-01987 (Patient C.H.) At the time of the events giving rise to this case, C.H. was a 23-year-old woman. She was married and attending her final year of chiropractic school in Kennesaw, Georgia. C.H. testified that in December 2010, she had experienced a bout with the flu, including an episode where she passed out in the shower, for which she was prescribed a Z-pack, and recovered. She then had gum surgery during the Christmas break, requiring anesthesia, after which she visited her husband’s family in Missouri over the Christmas holiday. After C.H. returned to Georgia, she returned to class for the spring semester. In early February of 2011, she had an episode in class where her heart started beating very rapidly, and upon a physician’s advice, went to the emergency room. Tests given there were normal. Follow-up tests also did not reveal the basis for her symptoms, and in March 2011, her mother contacted Dr. Lentz based upon the suggestion of a family friend who had treated with him. On or about March 20, S.H. contacted Respondent by e-mail regarding her 23-year-old daughter, C.H. S.H. had been referred to Respondent by a family friend. S.H. reported that she had found a checklist for Lyme disease symptoms online, which included some of the symptoms her daughter was experiencing, such as fatigue, rapid heartbeat, chest pain, headaches, blurry vision, and difficulty concentrating. She also related that C.H. was in her final year of chiropractic school and had recently completed her national boards, and thought that some of the symptoms might be related to stress and anxiety from her studies. In that e-mail, S.H. reported to Respondent that C.H. had tested negative for Lyme disease the previous week. Respondent received a copy of C.H.’s negative Lyme disease test report from blood collected on or about March 16, 2011. On or about March 22, 2011, Respondent documented his assessment of C.H. as Lyme disease and chronic fatigue syndrome. He ordered CD57, C3a, C4a, and ECP laboratory tests of C.H.’s blood. At the time these tests were ordered, Respondent had not seen or talked to C.H., taken her history, or performed a physical examination. Respondent did not at any time prescribe an ELISA test or Western blot test for C.H. On April 14, 2011, S.H. e-mailed Dr. Lentz to see if any test results had been received for C.H. Dr. Lentz replied, “CD57 51+ positive for Lyme. Babesia is negative at this time.” When asked how to proceed, he told her she needed to start treatment until the CD57 is over 120.12/ S.H. asked via e-mail whether C.H. should get treatment from Dr. Lentz or her family doctor, saying they would prefer to work through him, as this is his specialty. Dr. Lentz responded, “This is more than a good family physician can handle. I have 35 years of family practice and know first hand. Lyme is a multi-faceted problem and requires extra time and effort to educate and direct this complex problem.” On or about April 18, 2011, Respondent prescribed the antibiotics Omnicef (cefdinir) and azithromycin to C.H. At the time he prescribed these medications, Respondent had not seen C.H., and there is no documentation in the patient records that Respondent made any inquiry regarding potential allergies before prescribing these antibiotics. On or about April 25, 2011, C.H. presented to Respondent for the first, and only, office visit. The medical records for that date contain symptoms that C.H. credibly denies having reported to him, such as double vision, twitching, tremors and shakes, explosive (behavior), and shortness of breath. C.H. does not recall being weighed at that visit, although the record contains a weight for her. It does not however, indicate her temperature, pulse, or respiration rate. She recalls a minimum examination for which she remained clothed in shorts and a t- shirt. During the examination, Respondent asked if she had ever been bitten by a tick or had a rash, and checked some areas of her body for a tick bite/rash, which she denied ever having. Dr. Lentz did not inquire about her travel history. Despite the fact that one of her symptoms was the inability to take a deep breath and had suffered from heart palpitations, his patients do not reflect a temperature, pulse, or respiration rate. At that visit, Respondent added the antibiotic Flagyl (metronidazole) and Interfase Plus Prothera, an enzyme formulation, to C.H.’s medications. C.H. testified that at that visit, Dr. Lentz told her that he was a specialist with numerous years of experience, and that he was the only one certified to be able to treat this, and she would have to be under his constant care. C.H. also testified that he told her she would need to be medicated for the rest of her life, because Lyme disease lives forever in your body, and that she would probably never be able to get pregnant or have children. C.H. was devastated by this information. The entire visit with Dr. Lentz, including both the taking of her history and the physical examination, lasted approximately ten minutes. C.H.’s testimony is credited. On or about June 10, 2011, Respondent prescribed CD57, C3a, C4a, and ECP tests for C.H. On or about July 2, 2011, Respondent prescribed C.H. with Babesiosis. He made this diagnosis completely on the basis of test results, as C.H. had not returned to his office after her first and only visit. On or about July 9, 2011, Respondent added artemisinin (an antimalarial), Hepapro (a nutritional supplement); Mepron (atovaquone, an antiparasitic), heparin injections (an anticoagulant), magnesium oxide (antacid, laxative, dietary supplement), and omega-3 fatty acids to C.H.’s treatment. Respondent did not prescribe a blood smear examination for Babesial parasites or PCR amplification for Babesial DNA for C.H. At no time during her treatment did Dr. Lentz refer C.H. to a specialist. Indeed, he represented to her and to her mother that he was a specialist in Lyme disease and that he was better equipped to treat these conditions than a normal family practitioner would be. C.H.’s condition worsened rather than improved under the medication regimen Dr. Lentz prescribed. She suffered diarrhea and blurred vision and her other symptoms did not improve. Dr. Joel Rosenstock is a medical doctor licensed to practice medicine in the State of Georgia. He is board certified in internal medicine with a subspecialty in infectious disease, and has practiced infectious disease medicine for over 30 years. During the time related to this proceeding, Dr. Rosenstock was practicing in Atlanta, Georgia, at the AbsoluteCARE Medical Center and Pharmacy. C.H. first presented to Dr. Rosenstock on July 12, 2011, at which time she reported Dr. Lentz’s diagnoses of Lyme disease and Babesiosis. In contrast to her brief visit with Dr. Lentz, her consultation with Dr. Rosenstock lasted two to three hours. Dr. Rosenstock immediately ordered a Western blot test for C.H., which was negative. He conducted a thorough history and physical for her, and asked C.H. questions about her travel history, her dogs and where they slept, her hobbies, etc. He advised her that he did not believe that she had Lyme disease or Babesiosis, and recommended that she stop all of the antibiotics and other medications that Dr. Lentz had prescribed. He warned her that it could take several months before the drugs were out of her system, so relief from the side effects would not be immediate. Within a few weeks of stopping the medications, C.H. was feeling much better and was on her way to feeling back to her old self. Dr. Rosenstock did not believe that any of the tests that Dr. Lentz ordered for C.H. were useful in diagnosing Lyme disease or Babesiosis, and did not believe that heparin served any purpose in treating C.H. Based on the credible opinions of Drs. Powers and Robbins, and the testimony of Dr. Rosenstock as a subsequent treating provider, it is found that Dr. Lentz departed from the applicable standard of care in the care and treatment of C.H. in several respects. First, Respondent departed from the applicable standard of care by ordering blood tests and prescribing antibiotic treatment for C.H. (as well as other medications) when he had never actually seen her. At the time he ordered the blood tests, and at the time he first ordered medications for C.H., he had not obtained a history for her, much less a history that was suggestive of Lyme disease, and had not conducted a physical examination of any kind. All he had as a basis for ordering tests was the e-mail from her mother. This e-mail was an insufficient basis upon which to determine that testing for Lyme disease was warranted. When he did actually see C.H., he failed to perform an adequate physical examination and failed to take an adequate history that included travel history, possible exposure to ticks, how long any tick bite may have lasted, and the size and appearance of the tick. Respondent failed to use the generally accepted tests for the diagnosis of Lyme disease and Babesiosis, instead relying on tests that are meant for investigational purposes and indicate on their face that they are not meant for diagnostic purposes. Moreover, as noted above, at the time he ordered the tests, he had no basis upon which to believe C.H. had Lyme disease. Although even his own expert witness consistently stated that a diagnosis of Lyme disease is based in large part upon a thorough history, here, Dr. Lentz had no history. Dr. Cichon’s testimony that it was appropriate to rely on the information in S.H.’s e-mail about her daughter’s symptoms (keeping in mind that her daughter is an adult, not a child) is rejected as not credible. Respondent also departed from the applicable standard of care by prescribing Omnicef, azithromycin, artemisinin, Hepapro, Mepron, heparin injections, magnesium oxide, and omega-3 fatty acids for a condition that she did not have. Given that C.H. had no condition justifying the prescription of these drugs, the prescriptions were both inappropriate and excessive. They also were prescribed for a duration that was not justified, and exposed C.H. to complications that were unnecessary. Respondent was required to keep medical records that justified the course of treatment. His medical records for C.H. fell well short of this requirement. He failed to document a complete history, an adequate physical examination, or why he did not refer her case to a specialist. He also departed from the applicable standards when he used a diagnosis of Lyme disease as the basis for blood tests at a time when he had never seen the patient. Failure to Timely Report Diagnoses or Suspicion of Lyme Disease to the Department of Health (DOAH Case Nos. 15-2889 and 15-2890) Finally, in DOAH Case Nos. 15-2889 and 15-2890, the Department alleged that Respondent failed to report his diagnoses of Lyme disease or suspicions of Lyme disease for patients D.H., J.L., W.L., S.L., D.D., and C.H. to the Department of Health. Section 381.0031, Florida Statutes (2010-2011), requires certain licensed health care practitioners and facilities in Florida to report the diagnosis or suspicion of the existence of diseases of public health significance to the Department of Health. Lyme disease is one of the diseases identified by rule that meets the definition of a disease that is “a threat of public health and therefore of significance to public health.” § 381.0031(2), Fla. Stat.; Fla. Admin. Code R. 64D-3.029. There are forms that are identified by rule for use in reporting these cases. Fla. Admin. Code R. 64D-3.030(3). Ashley Rendon is a biological scientist for the Department of Health in Okaloosa County. Ms. Rendon is an epidemiologist whose duties include investigating reportable disease conditions and outbreaks of public health significance in Okaloosa County. According to Ms. Rendon, whose testimony is consistent with the Department’s rules on this subject, all diagnosed or suspected cases of Lyme disease must be reported to the Department. Once reported, the county health office will conduct an analysis of the reported diagnosis or suspicion, based on a “guidance to surveillance” document, to determine whether the reported case meets the definition for Lyme disease such that the case needs to be reported to the statewide system and to the CDC. Ms. Rendon testified that whether a suspected case or a diagnosis meets the case definition is not for the practitioner to decide. Ms. Rendon’s testimony is credited. According to Ms. Rendon, the Department maintains records both for those reported cases that met the case definition and those reported cases that did not. For 2010, there was one case of Lyme disease that was confirmed, probable, or suspect. None were reported for 2011. There were seven to eight additional cases that were reviewed, but not reported as probable, confirmed, or suspect. Not all reported results are confirmed by ELISA or Western blot. Ms. Rendon reviewed the records of the Department to determine whether Dr. Lentz had reported any cases of Lyme disease, whether suspected or diagnosed, to the Department. There was one instance where a patient of Dr. Lentz’s apparently called in and asked questions, but there was no record of Dr. Lentz or anyone in his office reporting Lyme disease. Dr. Lentz claimed that he had at least on one occasion attempted to report in the past, but that he could not say if he had reported any of the patients named in the Administrative Complaints. He claimed that the Department would not accept reports that are not supported by two-tier testing results, so he stopped trying to report. His claim is rejected as not credible. There is clear and convincing evidence to establish that Respondent failed to report his diagnoses of Lyme disease for patients D.H., J.L., W.L., D.D., S.L., and C.H. General Observations Of the seven patients presented in this proceeding, Dr. Lentz saw only two before ordering tests for Lyme disease and in some cases, Babesiosis or Bartonellosis. With respect to C.H., not only did he fail to see her before ordering testing, but he ordered medications for her without ever obtaining a medical history or performing a physical examination. Some of the patients specifically requested testing for Lyme disease. However, it is the physician’s responsibility to determine whether there is any realistic reason to believe that a patient has a need for such tests. Moreover, in several instances, the general, non-specific symptoms related by the patients suggest several other alternative conditions that could cause the patients’ problems. Even Respondent’s expert opined that Lyme disease, Bartonellosis and Babesiosis share a lot of general, non-specific symptoms with other illnesses, including serious diagnoses such as ALS, MS, and rheumatoid diseases. These are all, according to Dr. Cichon, differential diagnoses that a physician should sometimes consider when trying to find a diagnosis. Yet with all of these patients, Dr. Lentz went straight to Lyme disease every time. He did not consider much of anything else when even to a lay person, the records cry out for a more thoughtful and measured approach. In short, it seems that Dr. Lentz wanted to find Lyme disease regardless of the symptoms presented, and so he did. By doing so, he cost these patients not only the money used for testing and, with respect to C.C., W.L., S.L., and C.H., subjecting them to treatments they did not need and, in at least with respect to S.L., could not afford, but he subjected them to a treatment regimen that made them miserable, was of questionable benefit, and exposed them to unnecessary risks. Petitioner presented the expert testimony of Dr. Charles Powers, a general family practitioner, and Dr. William Robbins, an infectious disease specialist. It also presented the testimony of subsequent treating physicians: Dr. Janelle Robertson, Dr. Patrick Anastasio, and Dr. Joel Rosenstock. Each subsequent treating physician testified credibly that the symptoms presented simply did not justify a diagnosis of Lyme disease, and the testing they either conducted or reviewed did not indicate a basis for such a diagnosis. Their testimony was consistent with that of both expert witnesses presented by the Department, and the testimony of these subsequent treating physicians and expert witnesses have been accorded great weight. Respondent presented the testimony of Dr. Michael Cichon, a retired infectious disease specialist. Dr. Cichon’s testimony was in many respects inconsistent, and at times he seemed to be struggling to actually support the care and treatment that Respondent performed in these cases. While he championed Respondent’s use of the CD57, the ECP, and the Fry test, he also admitted that he seldom, if ever, used some of these tests, and that there were problems with standardization of the tests. Moreover, the tests themselves indicated on their face that they were for investigational, as opposed to diagnostic, use, and should not be used as the sole basis for diagnosis of patients. Because of the significant inconsistencies with his testimony and the contrasts between what he advocated and what Dr. Lentz sometimes did, his testimony is given little weight.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding that Respondent has violated section 458.331(1)(g), (m), and (t), as alleged in the three Administrative Complaints at issue in this proceeding; and by the findings that Respondent violated section 458.331(1)(t) with respect to all seven patients, Respondent is guilty of repeated malpractice. It is further recommended that the Board of Medicine revoke his license to practice medicine in the State of Florida, impose an administrative fine in the amount of $30,000, and impose costs pursuant to section 456.072. DONE AND ENTERED this 8th day of July, 2016, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of July, 2016.
The Issue The issues concern the Petitioner's candidacy for licensure as a chiropractic practitioner in Florida. In particular, Petitioner stood examination for licensure in November, 1987, and was not successful in that attempt. Consequently, he has challenged the examination results in the portion of the examination related to physical diagnosis. His examination results have otherwise been sufficient to gain licensure. The Petitioner's claims in this challenge to the examination results relate to his assertions that the examination questions in dispute were not reasonable, alternatively that the answers given were sufficient and that contrary to Rule 21-11.009(2) and (3), Florida Administrative Code the examiners in the oral examination phase of his testing conferred in assigning a score to his performance instead of arriving at a score independently.
Findings Of Fact Petitioner, John G. Bahrs, is a graduate of Life Chiropractic College in Atlanta, Georgia, having graduated in June, 1987. He currently resides in Gainesville, Florida, at the address previously identified. In November, 1987, Petitioner took the Florida license examination to gain a license to practice chiropractic in Florida. The summarizing results of the various phases of that examination may be found in Respondent's exhibit no. 1 which is a copy of the examination results. It notes the requirement that the candidate receive a score of seventy-five (75) percent to pass the physical diagnosis portion of the examination. The score received by the Petitioner was sixty (60) percent. Having been unsuccessful in attempts to gain an adjustment of that score through an informal process, Petitioner requested a formal hearing in accordance with Section 120.57(1), Florida Statutes. That request was honored by the submission of this case to the Division of Administrative Hearings for assignment of a Hearing Officer and a subsequent hearing which was held on October 3, 1988. Under the general category of physical diagnosis there are various sub- elements to that examination process. In each of those areas, Petitioner received the minimum passing score of seventy-five (75) percent by the examiners, who are referred to as examiners numbers 23 and 25, with exception of scores related to laboratory diagnosis, nutrition and x-ray technique and diagnosis. The score assigned by examiner number 25 on laboratory diagnosis equates to fifty (SO) percent and the nutrition score likewise. Examiner number 23 assigned a laboratory diagnosis score of fifty (50) percent and nutrition, twenty-five (25) percent. He also gave the Petitioner a score of fifty (50) percent on x-ray technique and diagnosis. This analysis of the scores received in the sub-elements to the examination may be found in Respondent's exhibit no. 2, a copy of that compilation which has been admitted as evidence in this case. In addition to the break out of the scores, there is a comment section prepared by each of the graders; this, together with an analysis of the written recap of these phases of the examination process and the testimony of the Petitioner and the Respondent's chiropractic expert, focuses the dispute and allows a factual analysis to be made. The expert who testified for the Respondent Agency is Dr. Steven M. Ordet. He is a graduate of the National College of Chiropractic in Lombard, Illinois. He achieved that degree in 1974. At present, he is a consultant, lecturer and author. He practiced chiropractic in Ft. Lauderdale, Florida, between the years 1974 and 1985. He is a member of the American Chiropractic Association and Florida Chiropractic Association. He has been associated with the 1icensure of candidates in Florida for approximately seven (7) years as an examiner and consultant. In the subsection of the examination for which Petitioner received substandard scores on nutrition, examiner 23 noted that the Petitioner had received no training in that field. Examiner 25 made notations concerning the Petitioner's lack of understanding of the effects of use of iron and the implications of a vitamins B 6 deficiency. In his oral examination phase on nutrition, one of the questions posed related to a patient who was experiencing swelling in her hands in the morning and problems with her rings being too tight and burning in the soles of her feet. Petitioner was asked if there was some supplementation that might be provided to that patient that would assist the patient in her condition. In response, the Petitioner indicated that he had not had the type of training in his education that would lead to any specific clinical decision and that this, nutrition, was not one of his strong points. Petitioner made the suggestion by way of a query that this might sound like an edema problem to which the retort by an examiner was to the effect that you tell the examiners what you think should be done, meaning by supplementation. At hearing, the Petitioner indicated that his training in school in nutrition had related to what the food groups consist of, what vitamins are about, what minerals are and carbohydrates, proteins, again, basic information not sufficient to respond to some particular condition that a patient was experiencing. As identified by Dr. Ordet, the supplement for the problem described in the previous paragraph is pyridoxine, vitamin B 6, which is a natural diuretic that would help to reduce edema. The Petitioner did not respond sufficiently to the question under examination. Furthermore, his references provided at hearing on the topic of pyridoxine do not disturb the opinion of Dr. Ordet. Another question under the category of nutrition was to the effect that this patient, the hypothetical patient, a woman, takes vitamins and minerals regularly and is experiencing constipation and the Petitioner was asked what would cause this problem of those substances being utilized. Petitioner responded from a supplementation standpoint that he couldn't answer specifically but knows that generally you can overload a patient with supplements and can cause diarrhea or constipation. The proper answer as identified by Dr. Ordet would be that iron could cause the problem of constipation. Iron is a mineral. This is another instance in which the reference sources that the Petitioner presented did not dispel the conclusions reached by Dr. Ordet. Under the heading of x-ray technique and diagnosis, the examiners asked the Petitioner about the x-ray of a lower back involvement. He described an anterior to posterior examination in which a bucky was employed in a lateral cervical setting. He went on to describe that a non-bucky was used in x-ray of extremities measuring less than ten (10) centimeters. A further question concerned whether you would use more or less exposure going from 8 to 1 to 12 to 1 ratios and employing a bucky, to which the Petitioner indicated you would use less exposure. It is that portion of the questions which related to the ratio being increased and the belief expressed by the Petitioner that would cause less exposure that made examiner 23 grade the Petitioner down to a fifty (50) percent rating. Dr. Ordet, whose opinion is accepted on this matter, felt that the cervical view was a non-bucky projection, which contrary to the Petitioner's assertion is a matter which should be evident as a standard applied to all training in x-ray techniques. Therefore, Petitioner's claim that his schooling would allow the bucky to be employed in this form of projection is out of keeping with acceptable standards. Moreover, Dr. Ordet pointed out that the ratio increase would promote further exposure to the patient, not less exposure as answered by the Petitioner causing him to be downgraded by examiner 23. Petitioner's contention that the questions that preceded the matter of the increase in ratio were related to film exposure and not patient exposure misstates the context of those questions in this portion of the examination. It is clear that what was being referred to was the effect on the patient, not the effect on the film. The reference material which Petitioner has provided tends to confirm that the increase in ratio will increase the amount of exposure to the patient. Under the heading of laboratory diagnosis, the question was posed to the Petitioner that a female patient presents with tenderness above the pubic bone with difficulty urinating, burning sensation and pain, and he was asked to provide a statement of what laboratory tests would be ordered by the Petitioner and what would one look for through that analyses. The Petitioner responded that there is an indicated bladder infection and stated he would do an urinalysis. He was then asked what he might expect to see under that analysis and he said that he would expect to see cells, red blood cells and increased white blood cells and infection. He was asked what kind of white blood cells he would find in the urine and he said that he would see neutrophils in a microscopic examination. He again mentioned red blood cells and squamous epithelial cells in the bladder infection. In describing what he might see up in the area of the kidney, he said that he would see renal cells which are smaller and rounder compared to the epithelial cells in the area of the bladder which are larger and irregular in shape. As to a question about what he would expect to see in the way of a Ph in this case as presented compared to the normal condition, he said that he expected to see acidic values in that patient compared to the normal values which were in a range of 4.6 to 6.8 Ph. Then he stated between 4 and 6 Ph. According to Petitioner the Ph in the patient's condition would be a shift toward 4 and closer to 4 than the other end of the Ph scale. Examiner 25 had :noted that the Petitioner had insufficient knowledge of the situation in the test and Examiner 23 referenced the remarks about acidic Ph and the round kidney cells. By way of interpretation of the concerns which the examiners had In the area of laboratory diagnosis Dr. Ordet, whose opinion is accepted, noted that white cells in the urine any level show an abnormal condition. It is not the increase in those white cells that is significant. He also observed that the white cells would not be identified as neutrophils. The laboratory process, urinalysis, does not further describe the nature of the cells or than that they are white cells. Dr. Ordet identified that the nature of the cells in the kidney area were those associated with casts. Their relative size and shape are not the important factors. Consequently, the remarks by the Petitioner about size and shape of the cells in the bladder and the kidney are not significant. What is significant is to look for bonding between some foreign material and the cell forming casts in the kidney. One of the products in a cast might be calcium oxalate. Dr. Ordet noted that the Ph in the urine with the infection in this patient's case would be more alkaline, as opposed to acidic. Petitioner's reference sources concerning the urinary condition do not overturn the impressions which Dr. Ordet had of this condition in the hypothetical. Dr. Ordet has stated the opinion that the questions which were challenged were fair questions in examining a candidate for licensure as a chiropractic physician. His opinion is accepted and the opinion of the Petitioner that the questions were not fair is rejected. Petitioner, at hearing, suggested that the tape cassette of his examination which is exhibit 3 by the Respondent pointed out that contrary to Rule 21-11.009 (2) and (3), Florida Administrative Code, examiners 2 and 25 conferred in reaching conclusions about scores to be assigned to Petitioner's examination. A thorough review of that cassette does not reveal any arrangements of that sort. Their remarks indicate that the examiners were checking to see what sub-categories were involved in the examination as depicted in Respondent's exhibit number 2, and to verify that each examiner acknowledged what those sub-categories were.
The Issue The issues in this case are whether Respondent violated Subsection 458.331(1)(t), Florida Statutes (2004),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. Dr. Patel is a licensed physician within the state of Florida, having been issued license number 54617. He has been board certified in general surgery since 1990 and has been practicing medicine in Florida since 1989. For the past 20 years, S.A. has had yearly gynecological examinations and mammograms. In 1994, a mammogram revealed a lump in her left breast. She was referred to a specialist, who removed the lump. The biopsy revealed that the lump was a fibroadenoma, which is a common, benign tumor of the female breast with unknown etiology. In 2004, S.A. found a lump in her right breast during a self-examination. She consulted her gynecologist, Dr. Hae Soo Lim, who had been prescribing Clomid for S.A. Dr. Lim advised S.A. that the Clomid could be causing the lump. S.A. discontinued taking Clomid, but the lump did not dissipate. In August 2004, Dr. Lim ordered a mammogram for S.A. The mammogram did not reveal an abnormality in the right breast. Because a lump could be felt on examination, S.A. was advised to have a supplemental bilateral breast sonography. A sonogram was performed on the same date as the mammogram and revealed the following as it related to the right breast: In the area of palpable abnormality, there is a solid hyperechoic nodule that has a central cleft. It is more ethogenic than the adjacent breast parenchyma and could therefore represent a focal fatty deposit or area of breast tissue fibrosis. This measures approximately 1.5 cm x 1.2 cm. This is 5 mm beneath the skin surface and is readily palpable. This is 5 cm away from the nipple in the 12 o'clock position. Using color flow Doppler imaging, no vascular flow is demonstrated within the lesion. This would further support probable benign etiology. This does not have the appearance of a complicated cyst or of a typical fibroadenoma or malignancy. CONCLUSION: Hyperechoic nodule accounting for palpable abnormality. This is not seen mammographically. This has indeterminate characteristics and most likely represents a focal fatty deposit and/or area of breast tissue fibrosis. A biopsy or excision would be needed to establish pathology. It is noted that the patient states that this fluctuates in size during the course of her period. Dr. J.M. Swalchick, who prepared the report of the sonogram findings, recommended a surgical consultation for the palpable abnormality in the right breast. Dr. Swalchick noted in his report that he discussed his findings with S.A. at the time of the performance of the sonogram. His discussion was limited to telling S.A. that she should follow up with a surgical consultation and that he would send the report to Dr. Lim. On or about August 12, 2005, S.A. presented to Dr. Patel for a surgical consultation and evaluation of the mammogram and breast ultrasound reports upon referral from Dr. Lim. Dr. Patel reviewed the mammogram, ultrasound, and the accompanying radiology reports. In his office notes, which were dictated within 24 hours of S.A.'s visit, Dr. Patel made the following findings during his examination of S.A.'s right breast: Patient has a small palpable nodule in the right breast at 12:00 to 11:00 position and appears to be right under the skin. Appears to be more likely a simple fibroadenoma without any skin dimpling or any nipple or skin retraction. Patient did not have any axillary adenopathy. Dr. Patel made the following notation of S.A.'s August 12, 2004, office visit: Patient was explained regarding her mammogram, regarding her ultrasound exam and also regarding various breast problems with the help of the booklet on the breast disorders and was advised that what appears to be a palpable nodule seen on the ultrasound is a fibroadenoma and she can be followed clinically and will advise her to be seen again in six months in follow up. Patient explained that if she wants this to be removed, it can be removed either in the office or in outpatient surgery and the patient is agreeable to have simple follow up done and will be seen again in six months. Dr. Patel does not have a specific recollection of S.A.'s office visit on August 12, 2004, other than what he wrote in the patient's chart. Dr. Patel's office notes comport with S.A.'s testimony that he told her that she had a fibroadenoma. He did not tell S.A. that the lump was indeterminate. Based on Dr. Patel's representation that the lump was a fibroadenoma, S.A. elected to wait and return to Dr. Patel in six months for a follow-up visit. There is conflict between S.A.'s testimony and Dr. Patel's office notes concerning whether he explained the mammogram and ultrasound to her and whether he showed her a booklet on breast disorders. I credit Dr. Patel's office notes in that he did discuss the mammogram and ultrasound tests with S.A. and that he did go over a booklet with S.A. on various breast disorders. Additionally, I credit Dr. Patel's notes that he told her that he could remove the nodule in his office if she desired. However, I credit S.A.'s testimony that Dr. Patel told her that she had a benign fibroadenoma and had nothing to worry about. Had Dr. Patel told her that the lump was indeterminate, S.A. could have made an informed decision concerning the removal of the mass versus waiting six months to see what would happen. On February 22, 2005, S.A. returned to Dr. Patel's office for a follow-up visit. The lump was still present. Based on Dr. Patel's office notes, he was still under the impression that the lump was a benign fibroadenoma. He told her that he would remove the lump in his office under local anesthesia. Another office visit was scheduled to remove the lump. On or about March 8, 2005, Dr. Patel excised the breast mass in his office using local anesthesia. A biopsy of the excised tissue revealed that S.A. had an infiltrating ducal carcinoma (breast cancer). On or about March 14, 2005, Dr. Patel performed a right partial mastectomy on S.A. Dr. Armand H. Katz testified as an expert for the Department. Dr. Katz's testimony is credited that the standard of care required that Dr. Patel tell S.A. that the lump was indeterminate and could be cancerous.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: A Final Order be entered finding that Dr. Rameshibhai P. Patel violated Subsection 458.331(1)(t), Florida Statutes; placing him on probation for one year with indirect supervision, with the terms to be set by the Board of Medicine; requiring completion of five hours of continuing medical education in risk management; and imposing an administrative fine of $1,000. DONE AND ENTERED this <day> day of <month>, <year>, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this <day> day of <month>, <year>.