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 The issues in these cases are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2002), in DOAH Case No. 09-4678PL; Subsections 456.072(1)(l), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2003), in DOAH Case No. 09-4679PL; and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2005), in DOAH Case No. 09-4680PL, and, if so, what discipline should be imposed.
Findings Of Fact At all times relating to the three Administrative Complaints at issue, Dr. Kachinas was a licensed medical doctor within the State of Florida, having been issued license number ME 65595. He is board-certified by the American Board of Obstetrics and Gynecology. DOAH CASE NO. 09-4678PL In 2002, Dr. Kachinas was working at several clinics that were owned by the same individual. He received payment from Sarasota Women’s Health Center and Tampa Women’s Health Center. His primary office was located in Sarasota, but he rotated through the offices located in Clearwater and Tampa. He was advised that he would be attending a patient in the Tampa office. One of the medications that he used in his method of sedating patients, Propofol, was not available in the Tampa office. He took a vial of the Propofol and took it to the Tampa office, holding the vial in his hand. While at the Tampa office, Dr. Kachinas drew the Propofol into a syringe. He did not have to use the Propofol for the patient. He placed the syringe filled with Propofol inside the sock that he was wearing. Dr. Kachinas transported the syringe back to the Tampa office. He used this method of transport so that the office manager in the Tampa office would not know that he was transporting the drug. When he got back to the Tampa office, he placed the filled syringe in a secure place. Propofol must be used within 24 hours after being drawn into a syringe. The next day it was decided that the drug would not be used on another patient, and Dr. Kachinas wasted the syringe filled with Propofol. At the clinics where Dr. Kachinas worked, there were no logs to keep track of the drugs, except for the drug Fentanyl. Dr. Kachinas acknowledged in a letter dated January 30, 2007, to the Department of Health that his method of transporting Propofol was “unorthodox.” In the same letter, Dr. Kachinas acknowledged that “a reasonable and prudent doctor would not generally transport medication in that manner, but foolishness seemed reasonable in that aberrant environment.” DOAH CASE NO. 09-4679PL On March 26, 2004, B.S. presented to Premier Institute for Women’s Health (Premier) for an elective termination of pregnancy. Dr. Kachinas was the physician who handled the procedure. Dr. Kachinas maintained records relating to B.S. at Premier. In 2004, Petitioner subpoenaed B.S.’s records from Dr. Kachinas’ office. Petitioner received a packet of documents, which purported to be B.S.’s medical records. In July 2006, Lori Jacobs, an employee of Premier, sent Petitioner another copy of the documents sent in 2004. Neither the records provided in 2004 nor the records provided in 2006 contain progress notes for B.S.’s treatment on March 26, 2004, and March 27, 2004. For the first time on November 5, 2009, Dr. Kachinas produced a three-page document, which he claimed was part of B.S.’s medical records that had been misplaced in B.S.’s insurance file. Two of the pages purported to be progress notes for March 26 and 27, 2004. The third page, which is also labeled as a progress note, is dated June 29, 2004, and appears to relate to insurance claims. The two pages relating to March 26 and 27 are on paper which is a different color from the progress note relating to insurance claims and the progress notes which were previously furnished in 2004 and 2006.1 Additionally, the progress notes for March 26 and 27, 2004, contain a break in each of the ruled lines on the sheets on both the right and left sides of the sheets. The insurance progress note and the progress notes furnished in 2004 and 2006 do not have such breaks in the ruled lines. Dr. Kachinas completed a Laminaria Insertion report documenting procedures done on March 26, 2004, and March 27, 2004. The March 26, 2004, report documents the insertion of Laminaria and administration of medications. The comment section of the report documents the removal of the Laminaria and administration of medications on March 27, 2004. The comment section continues to document the administration of medications and the taking of vital signs after the removal of the Laminaria and also the transfer of the patient to Doctors Hospital. The detail on the comment sections suggests that Dr. Kachinas was making his progress notes in the Laminaria Insertion report. The failure to produce the purported progress notes for March 26 and 27, 2004, until November 5, 2009; the difference in the color of the paper of the March 26 and 27, 2004, purported progress notes and the other progress notes in Dr. Kachinas’ records; the presence of breaks in the ruled lines on the March 26 and 27, 2004, purported progress reports, which do not appear on the other progress notes; and the detail of the comments on the Laminaria Insertion report support the conclusion that the progress notes submitted as Respondent’s Exhibit 1 were not done contemporaneously with the treatment given to B.S. on March 26 and 27, 2004, but were prepared for this proceeding. Thus, the progress notes for March 26 and 27, 2004, are not credited. Dr. Kachinas determined B.S.’s pregnancy to be at approximately 23½-to-24 weeks’ gestation, the last week of the second trimester. He confirmed by sonogram that the gestation period was 24 weeks. On March 26, 2004, Dr. Kachinas began the induction of labor ordering the insertion of ten Laminaria, which are osomotic cervical dilators which cause the cervix to open and allow easier emptying of the uterus. Dr. Kachinas’ records do not show that B.S.’s medical history was taken prior to the insertion of the Laminaria. However, Dr. Kachinas did take a medical history of B.S. at the time of her admission to Doctors Hospital, and the history is recorded in the medical records. Prior to the insertion of the Laminaria, Dr. Kachinas’ records do show that a limited physical examination of B.S. was done. The Laminaria Insertion report shows that B.S.’s baseline blood pressure, temperature, and pulse were taken and recorded. There was no expert testimony of what other physical examination should have been done. Dr. Kachinas injected the fetus with Digoxin, which is injected directly into the fetus to stop the fetal heartbeat, causing an Intrauterine Fetal Demise (IUFD). The injection of the Digoxin was not documented in B.S.’s medical records. B.S. was then released from Premier. On March 27, 2004, B.S. returned to Premier. Prior to removing the Laminaria, Dr. Kachinas did an ultrasound and determined that there was still fetal heart activity and fetal movements. Dr. Kachinas continued the labor induction procedure by removing the Laminaria and administering Cytotec and high dosages of Pitocin. When the Laminaria were removed, there was a rupture of membranes with a loss of essentially all the amniotic fluid. Sometime during the afternoon of March 27, 2004, Dr. Kachinas did another ultrasound and determined that there was no fetal heart activity. Based on the length of time from the Digoxin injection to the ultrasound showing no fetal heart activity, the loss of amniotic fluid, and the administering of medication to cause contractions, Dr. Kachinas determined that the Digoxin injection was not the cause of death. On March 27, 2004, at approximately 6:30 p.m., Dr. Kachinas transferred B.S. to Doctors Hospital and had her admitted to the hospital for failure to progress with the induction of labor procedure. While at the hospital, B.S. continued to experience pain. On March 28, 2004, Dr. Kachinas performed the following procedures on B.S.: mini-laparotomy, hysterotomy, removal of products of conception, and a modified Pomeroy bilateral tubal ligation. In his description of the procedures, he stated that the fetal demise was at least of 48 hours duration. However, Dr. Kachinas’ records do not reflect the time of the fetal demise. Jorge Gomez, M.D., Petitioner’s expert witness, credibly testified that a physician is required to document the time of the fetal demise. In the hospital records following B.S.’s surgery, Dr. Kachinas listed the post-operative diagnosis as a failure to induce labor, an intrauterine fetal demise, a thin umbilical cord, and asymmetric intrauterine growth retardation, a condition in which the fetus is smaller than expected for the number of weeks of pregnancy. An autopsy was performed on the fetus. A surgical pathology report was also issued. The pathology report showed mild infarcts on the maternal side. On the fetal death certificate, Dr. Kachinas listed the immediate causes for the IUFD as a possible cord incident and multiple placental infarctions. Dr. Kachinas did not document the elective termination or the Digoxin injection on the fetal death certificate. Dr. Gomez disagrees with the reasons for IUFD given on the death certificate. His credible reading of the pathology report does not indicate that the infarcts were severe enough to have contributed to the fetal demise. His credible reading of the pathology report does not indicate that there was any evidence of a cord incident. Dr. Gomez is of the opinion that the cause of death should have been listed as elective termination. Dr. Gomez’ opinion is credited. However, Dr. Gomez did not give an opinion on whether the fetal demise was caused by the injection of Digoxin. DOAH CASE NO. 09-4680PL On December 13, 2005, K.M. was seen by Walter J. Morales, M.D., at Florida Perinatal Associates, which specializes in internal fetal medicine. Dr. Morales performed an ultrasound on K.M., who was pregnant with twins as a result of in vitro fertilization. The ultrasound revealed that the twins were fraternal, meaning that each twin had a separate placenta and a separate sac. One of the twins, Twin A, had an anomaly called a cystic hygroma, which results from an obstruction, causing the lymphatic fluid, which normally drains into the juglar vein, to accumulate in the neck area. Approximately 50 percent of the fetuses which have this anomaly in the first trimester also have a chromosomal anomaly, such as Down syndrome. The decision was made to have K.M. return to Florida Perinatal Associates in three weeks for further evaluation. On January 3, 2006, Edgard Ramos-Santos, M.D., a partner of Dr. Morales, performed another ultrasound on K.M. Dr. Ramos-Santos found that Twin A, a male, had a cystic hydroma, a thickening of the nuchal fold2, and shortened femur and humerus. These findings are soft markers for abnormal chromosomes. The ultrasound also revealed a possible heart defect. At the time of the ultrasound, Twin A was cephalic bottom, meaning that Twin A was positioned lowest in the uterus. Dr. Ramos-Santos also performed an amniocentesis on Twin A on the same date as the ultrasound. The amniocentesis showed that Twin A had an abnormal chromosome pattern compatible with trisomy 21 or Down syndrome. Both ultrasounds showed that Twin B, a female, appeared to be normal. At the request of K.M., no amniocentesis was performed on Twin B on January 3, 2006. At the time of the ultrasound performed on January 3, 2006, the presentation of Twin B was cephalic right. The findings of the January 3, 2006, ultrasound were discussed with K.M. and her husband. On January 9, 2006, Dr. Ramos-Santos discussed the results of the amniocentesis with K.M.’s husband. It was decided that a selective feticide would be performed on Twin A. Selective feticide is a procedure in which a solution of potassium hydroxide is injected into the fetus’ heart to make the heart stop beating. K.M. was referred to Dr. Kachinas at Premier for the selective feticide. On January 10, 2006, Roberta Bruce, a nurse at Florida Perinatal Associates, sent to Premier by facsimile transmission the January 3, 2006, ultrasound report for K.M. and K.M.’s insurance information. The cover page for the facsimile transmission included a note from Ms. Bruce, which stated: “* FYI Fetus have different gender. The male is the affected one.” The standard of care as specified in Section 766.102, Florida Statutes (2005), requires a physician performing a selective feticide to correctly identify the affected fetus. Dr. Kachinas did not correctly identify Twin A prior to performing the selective feticide and performed the procedure on Twin B, the normal fetus. Dr. Kachinas performed an ultrasound on K.M., but failed to identify the correct position of Twin A in relation to K.M. The ultrasound done on January 3, 2006, by Dr. Ramos-Santos showed that Twin A was located at the bottom and Twin B was located to the right of K.M. In his progress notes, Dr. Kachinas placed Twin A on the right and Twin B on the left. Although it is possible for twins to shift positions, it is not probable that the twins shifted from left to right. Dr. Kachinas performed an ultrasound, but failed to identify that Twin A was the fetus with multiple anomalies. Although the standard of care required Dr. Kachinas to do a Level 2 ultrasound evaluation, a Level 1 ultrasound evaluation would have identified the cystic hygroma, the shortened long bones, and the sex of Twin A. Dr. Kachinas failed to perform an adequate ultrasound evaluation by failing to identify the anomalies and the gender of Twin A. Dr. Kachinas’ notes do not show whether Twin A or Twin B had anomalies. His notes did not identify the sex of each of the twins. His notes did not document the attempts that Dr. Kachinas made to identify the anomalies such as a recording of the length of the long bones or any examination made to identify the sex of each of the twins. On January 24, 2006, K.M. returned to Florida Perinatal Associates for another consultation. Dr. Morales performed another ultrasound, which revealed that Twin A, who had the anomalies, was still viable. The ultrasound revealed the continued presence of a cystic hygroma, the thickening of the nuchal fold, shortened extremities, and a congenital heart defect. The ultrasound also showed that the viable twin was male. The presentation of Twin A was shown by the ultrasound as cephalic bottom.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4678PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2002), by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent physician as being acceptable under similar conditions and circumstances; finding that Dr. Kachinas did not violate Subsection 458.331(1)(m), Florida Statutes (2002); imposing an administrative fine of $2,500; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4679PL that a final order be entered finding that Dr. Kachinas did not violate Subsections 456.072(1)(l) and 458.331(1)(t), Florida Statutes (2003); finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2003); imposing an administrative fine of $1,000; and placing Dr. Kachinas on probation for one year. Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED as to DOAH Case No. 09-4680PL that a final order be entered finding that Dr. Kachinas violated Subsection 458.331(1)(t), Florida Statutes (2005), by committing gross medical malpractice; finding that Dr. Kachinas violated Subsection 458.331(1)(m), Florida Statutes (2005); imposing an administrative fine of $2,000 and placing him on probation for one year for the violation of Subsection 458.331(1)(m), Florida Statutes (2005); and revoking his license for the violation of Subsection 458.331(1)(t), Florida Statutes (2005). DONE AND ENTERED this 26th day of January, 2010, 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 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of January, 2010.
The Issue The issues in this case are whether Respondent, Robin L. Cannizzaro, D.V.M. (Respondent), committed the violations alleged in the Administrative Complaint dated July 13, 2009, and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency with the duty to regulate the practice of veterinary medicine in Florida pursuant to Chapters 455 and 474, Florida Statutes. At all times material to the allegations of this case, Respondent was a licensed veterinarian in Florida fully authorized to practice veterinary medicine. Respondent has been licensed since 1991 and holds license number VM 5903. At all times material to the allegations of this case, Respondent’s address has been 26139 Halsey Road, Brooksville, Florida. At all times material to the allegations of this case, Diane Weigandt was the owner of the cat known in this record as “Maddie.” Maddie was a young cat, and Ms. Weigandt took her to Respondent’s office on or about April 7, 2008. Ms. Weigandt wanted to have Maddie spayed, but another veterinarian had declined to do so because the preoperative blood work indicated an elevated liver enzyme (ALT). During the course of the visit with Respondent, it was determined that Maddie should have a blood draw to test, among other things, Maddie’s ALT. It was expected that, if the enzyme were within or close to a normal range, Maddie could have the procedure. Respondent decided a draw from Maddie’s jugular vein was needed based upon the volume of the sample required to perform the tests. The selected site of the blood draw is not in dispute. The site of the draw did, however, cause Maddie to react uncooperatively. In order to make the blood draw, Respondent determined that Maddie would have to be restrained. It is not uncommon for cats to resist this procedure. Most pets, in fact, are not cooperative with jugular blood draws. During the first attempt to draw the blood, Respondent’s assistant held Maddie by the scruff of her neck on her side with her legs pinned. This position did not contain the struggling feline. As Maddie struggled to avoid the blood draw, Respondent made several attempts, using four different syringes, to acquire the sample. Approximately half-way through the procedure, Respondent’s assistant taped Maddie’s legs together so that they were further restrained. Between each attempt to draw blood, Maddie was afforded a break. “Break” meaning a brief intermission from the struggle that ensued each time Respondent attempted to draw blood. After approximately 20 minutes, Respondent obtained a small sample, but Maddie collapsed at the end of the blood draw. Respondent quickly performed CPR and was able to revive Maddie and get her stabilized within a short period of time. At the conclusion of the visit, Respondent referred Ms. Weigandt to a specialist to deal with Maddie. Respondent advised Ms. Weigandt that another doctor needed to rule out a pulmonary or cardiac medical condition for Maddie’s collapse. Had Maddie not appeared stable, Respondent would not have sent the cat on her way. When Ms. Weigandt presented at the second veterinarian’s office, Respondent faxed the results of the blood draw taken earlier to the second veterinarian. Ms. Weigandt was advised that another blood draw would be necessary as the specimen from Respondent’s office was compromised. It is not disputed that the second veterinarian advised Ms. Weigandt that Respondent’s blood draw was inadequate for the purposes needed. Respondent acknowledged that the blood draw was hemolyzed, but averred that most of the tests were nevertheless valid. The compromised blood draw could have resulted from a number of conditions. First, due to the numerous attempts to draw blood, a hematoma appeared at the draw site. A hematoma is a collection of blood outside the blood vessel, either in the subcutaneous tissue or in the muscle surrounding the vein. When blood is drawn through a hematoma, there can be a breakdown of the red blood cells. Additionally, myoglobin or muscle fluid from the muscle surrounding the vein may also contaminate the sample. Finally, if the draw is done after the animal has eaten (a non-fasting draw), the sample may be lipemic. Lipemic refers to fat appearing in the blood that will show up anywhere from two to six hours after eating. Any of the conditions noted can adversely affect a blood draw and leave the sample compromised. In the instant case, approximately half of the tests performed on Maddie’s sample drawn by Respondent were deemed inaccurate or insufficient for medical purposes. After consideration of the circumstances and effectiveness of Respondent’s blood draw for Maddie, Ms. Weigandt challenged the credit card payment she made to Respondent for the blood testing. Admitting no error in treatment or procedure, Respondent allowed the challenge and voluntarily withdrew the charge. Respondent believed this was a gesture of goodwill and not an admission of any wrong-doing. Subsequently, Ms. Weigandt requested that Respondent provide her copies of Maddie’s medical records. To that end, Respondent gave Ms. Weigandt the option of having the records faxed to her new veterinarian at no charge or picking up a copy of the records for which she would be expected to pay a fee. Ms. Weigandt chose the latter option, as she wanted to keep a personal copy of her pets’ records. As it turned out, Ms. Weigandt was, in effect, seeking the records for all of her pets/patients for whom Respondent had provided services. The seven pets’ records were maintained under Ms. Weigandt’s name and were copied and provided to the owner/client. Respondent charged Ms. Weigandt $55.00 for 55 pages of records. The form verification of completeness executed by Respondent’s assistant provided that the records for Maddie constituted 32 pages. In this case, Respondent kept a file for Ms. Weigandt’s pets based upon the owner’s name and information. Within the single file, Respondent maintained pet data identified by pet name with treatment notes, medications, and other pertinent information. Respondent maintained the record for the seven pets owned by Ms. Weigandt and kept notes for office visits, telephone consultations, and other matters identified by pet name. Pertinent to this case, Respondent’s notation for Maddie for the date of the blood draw indicated “WNL.” The specifics of Maddie’s temperature, heart rate or respiration were not stated. “WNL” is short-hand for “within normal limits.” Data for Maddie’s weight, considered a basic “vital,” was not provided. Instead, Respondent’s note provided, “seems undersized for age.” The process Respondent used to attempt a blood draw from Maddie’s jugular vein is within the standard of care for such procedures. As to both the site of the draw and the restraint used to obtain a sample, Respondent’s conduct was within a standard of care to be expected given the combative nature of the patient. In all likelihood, given the totality of the situation, Maddie experienced a vagal bradycardia that was quickly and appropriately addressed by Respondent. Maddie was resuscitated in an appropriate manner and stabilized before being released. As to the medical records retained by Respondent, it is determined that such records did not contain the data and information expected and required by the standard in Florida. Pertinent information concerning Maddie’s pre-procedure condition was not noted. Finally, as to the charges imposed for the copying of Maddie’s medical record, it is determined that, pursuant to the rule, Respondent was allowed to charge $26.75 for Maddie’s record. Ms. Weigandt requested and obtained records for six other animals. Presumably, the $55.00 charged for such records covered not fewer than 23 pages of records. Assuming Respondent was entitled to charge $1.00 for each of those pages, Respondent would have been authorized to charge $49.75 for the records.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Veterinary Medicine enter a final order finding that Respondent failed to keep appropriate records as alleged in Count Two of the Administrative Complaint, imposing a penalty of reprimand and the costs of investigation, and dismissing all other counts of the Administrative Complaint as unfounded. DONE AND ENTERED this 13th day of October, 2010, in Tallahassee, Leon County, Florida. S J. D. PARRISH 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 13th day of October, 2010.
The Issue The issue in this case is whether the license of Allen B. Erde, M.D., should be disciplined by the Florida Board of Medicine based upon actions he is alleged to have taken, or failed to have taken, between August and November, 1986, in the care and treatment of his patient, C.W.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State Of Florida, having been issued license number ME-0008625. Respondent was C.W.'s obstetrician during her pregnancy in 1986, and initially examined her on August 26, 1986, when she was six weeks pregnant. During this initial visit, C.W. was informed by Respondent that her pregnancy was progressing normally. At her second visit, on September 23, 1986, Respondent detected no fetal heartbeat. However, he informed C.W. that this was not a problem. He requested that she bring her husband with her for her third visit so that they both could hear the heartbeat. Prior to her third visit, C.W. saw Respondent in his office on October 6, 1986, complaining of urinary problems, and a stiff neck and back. Respondent treated her for a urinary tract infection. Later that same day she began to bleed vaginally, passed clots and experienced cramping pains. She then saw Respondent at the Winter Haven Hospital emergency room, but was told that nothing seemed wrong. Respondent advised her simply to go home, put her feet up, and rest. There were several other occasions during October, 1986, when C.W. experienced cramping and vaginal bleeding. She called Respondent each time to express her concerns, but was told simply to lie down, and keep her feet up. On October 22, 1986, C.W. and her husband visited Respondent for her third scheduled visit. No heartbeat was heard. Respondent again told C.W. that there was no cause for concern, the baby was just small and probably behind her pelvic bone. C.W. was presumably 14 weeks pregnant at this time, but Respondent's office records indicate that the fetus was decreasing in size, there was no weight gain, and no heartone. C.W. continued to experience pain and bleeding, sometimes accompanied by clots. She was not gaining weight, and had none of the other indications of pregnancy which she had experienced in her prior pregnancies. C.W. continued to express concern to Respondent, but his advice remained simply to lie down, and keep her feet up. In response to a five day episode of bleeding, C.W. saw Respondent in his office on November 12, 1986. Although she was 17 weeks pregnant at that time, Respondent's office records indicate a fetus 14 weeks in size. Respondent did not order any fetal viability tests, and there is no evidence in his office record that he considered any testing of the fetus. C.W. saw Respondent for her fourth scheduled visit on November 19, 1986, and, again, no fetal heartbeat was detected. She was still experiencing vaginal bleeding. Her uterus was only 10-12 weeks in size, although she was presumably 19 weeks pregnant at this time. C.W. was distraught, and expressed great concern to Respondent that she was presumably almost five months pregnant and no fetal heartbeat had ever been detected. C.W. demanded that Respondent do something. He then ordered a quantitative Beta-subunit Human Chorionic Gonadotropin blood test to determine her hormone level. On November 2l, 1986, Respondent called C.W. at her place of employment, and informed her that her hormone levels were extremely low, and that she might not have a viable pregnancy. He told her she should keep her next regularly scheduled appointment with him, but if she experienced any severe bleeding or cramping to call him. C.W. left work and became increasingly upset. She contacted him later on that same day for a more complete explanation of what she should expect. Respondent told her that the fetus was "reversing itself and was losing weight instead of gaining." C.W. was not informed by Respondent that the fetus was not viable, and she took his advice to mean that if she was extremely careful there was still a chance of carrying the pregnancy to term. Respondent admitted to the Petitioner's investigator, Jim Bates, that he knew the fetus was dead at this time, but he was trying to let nature take its course, and if she did not abort in two or three months, he would take the fetus. Because she was extremely upset and her friends were concerned about the advice she was receiving from the Respondent, an appointment with another obstetrician, Dr. Vincent Gatto, was made for C.W. by one of her friends. Dr. Gatto saw C.W. on or about November 21, 1986, and after examining her he immediately diagnosed her as having had a missed abortion. A sonogram confirmed this diagnosis. A dilation and curettage was performed on C.W., and subsequent pathological reports revealed remnants of an 8-week fetus. The medical records which Respondent maintained of his care and treatment of C.W. are incomplete and contain discrepancies concerning his evaluation of the patient. They do not reflect C.W.'s numerous telephone calls, or that she was increasingly upset over the course of her pregnancy. There is no delineation of a plan of treatment in these records, or any explanation of the type of treatment he was pursuing for her. There is no explanation or justification in these records of Respondent's failure to order a sonogram or test, other than the one Beta-subunit Human Chorionic Gonadotropin, for C.W., although she repeatedly reported vaginal bleeding and cramping, and there was a continuing inability to detect a fetal heartbeat. Respondent failed to carry out the correct tests on C.W., and therefore, he failed to make a correct diagnosis of missed abortion, or to treat her correctly. He allowed her to carry a dead fetus for almost two months. Retention of the products of a non-viable pregnancy can lead to several complications, including infection, blood clotting and psychological trauma. In fact, this experience caused C.W. severe emotional anguish. In his care and treatment of C.W., Respondent failed to meet the standard of care that is required of a physician practicing under similar conditions and circumstances.
Recommendation Based upon the foregoing, it is recommended that Florida Board of Medicine enter a Final Order suspending Respondent's license to practice medicine for a period of five years, and imposing an administrative fine of $3,000. DONE AND ENTERED this 21st day of August, 1989 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1989. APPENDIX (DOAH CASE NO. 88-4785) Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding l. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 4. Adopted in Finding 5. 6-7. Adopted in Finding 6. Adopted in Finding 7. Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Finding 11. Rejected as irrelevant. 14-17. Adopted in Finding 13. 18-21. Adopted in Finding 12. 22. Adopted in Finding 14. The Respondent did not file Proposed Findings of Fact. COPIES FURNISHED: Mary B. Radkins, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Allen B. Erde, M.D. P. O. Box 1817 Winter Haven, FL 33883-1817 Allen B. Erde, M.D. 198 First Street, South Winter Haven, FL 33880 Dorothy Faircloth Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth Easley, General Counsel Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0729
The Issue Whether Respondent, Steven A. Magilen, M.D., violated Sections 458.331(1)(m) and (t), Florida Statutes, as alleged in an Administrative Complaint signed April 2, 2001, and filed with the Department of Health on April 3, 2001, and, if so, the penalty that should be imposed.
Findings Of Fact The Department of Health, Board of Medicine, is the state agency charged with regulating the practice of medicine in Florida. Section 20.43; Chapters 456 and 458, Florida Statutes. Steven A. Magilen, M.D., is, and was at the times material to this proceeding, a physician licensed to practice medicine in Florida, having been issued license number ME 002082. Dr. Magilen received his medical degree from the University of Brussels in Belgium in June 1972. He received his license to practice medicine in Florida in 1973 and completed a residency in general surgery at Mount Sinai Medical Center, Miami, Florida, in June 1976. He has maintained a private practice in Florida since 1976. Dr. Magilen is board certified in general surgery. His general surgical practice focuses on colorectal surgery and proctology. He is experienced in the use of colonoscopy, having performed an average of between 250 and 300 colonoscopies per year since approximately 1979. Dr. Magilen's address is 21150 Biscayne Boulevard, Suite 400, Aventura, Florida 33180. Dr. Magilen has not previously been the subject of a disciplinary proceeding.1 D. M., a female, was initially seen by Eugene Eisman, M.D.,2 an internist, who has continued to see D. M. for at least the past ten years. As early as 1991, D. M. related a five-year history of intermittent abdominal pain. D. M. was referred by Dr. Eisman to Dr. Magilen in June 1995,3 complaining of years of constipation, which she indicated was becoming worse. She also complained of rectal bleeding. D. M. was in her mid-60's in 1995. Rectal bleeding is one of the most common problems seen by Dr. Magilen, who sees primarily older patients. Rectal bleeding can be caused by colonic (relating to the colon) disorders or anal disorders. The typical anal disorder found in adults which results in bleeding is hemorrhoids. Colonic disorders which cause rectal bleeding include polyps, colon carcinoma (cancer), inflammatory bowel disease, ulcerative colitis, Crohn's Disease, diverticulosis, diverticulitis, and appendicitis. While rectal bleeding may occur with diverticulitis, it is less likely than with only diverticulosis.4 The disorder which is most threatening to a patient of the disorders that can cause rectal bleeding is colon cancer. If not timely identified, colon cancer can spread to an extent that surgical intervention will be ineffective and the patient will ultimately die. The typical signs of colon cancer include a change in bowel pattern, such as diarrhea or constipation, rectal bleeding, abdominal pain, and, in later stages, weight loss. Because D. M. had reported rectal bleeding, Dr. Magilen first looked for signs of hemorrhoids. After finding no such signs, Dr. Magilen recommended to D. M. that she undergo a colonoscopy to explore whether she was suffering from a colonic disorder. A colonoscopy is one of the diagnostic tools available to determine whether polyps or colon cancer are present in a patient experiencing rectal bleeding. A colonoscopy allows the physician to visually evaluate subtleties of mucosal changes of the colon by visually inspecting the lumen, or inside lining of the colon. Any problematic or suspicious tissue can be collected during the colonoscopy for later biopsy. The colonoscopy is performed by inserting a flexible tube with fiber optic capabilities into the rectum and up through the colon. The colon is the lower six to eight feet of the gastrointestinal tract, which runs from the mouth to the anus. The colon consists of a muscular wall with an inner lining of mucosa and an outer layer of serosa tissue. Typically, approximately 50% of the colon is attached to the inside of the belly cavity (the abdomen) by a suspensory fibrous tissue. Colon cancer typically is found in the mucosal surface of the colon and is most prevalent in the left colon (the rectum, sigmoid colon, the descending colon, and the distal transverse colon). Because a colonoscopy is an invasive procedure, it is not without risks. Among the risks of performing a colonoscopy is the possibility that the patient's colon will be perforated. Despite Dr. Magilen's concern over D. M.'s rectal bleeding, D. M. ignored Dr. Magilen's recommendation and declined to undergo a colonoscopy in 1995. D. M. was next seen by Dr. Magilen in April 1996. D. M. complained of constipation and bright red bleeding on the toilet paper in the bowl. At Dr. Magilen's urging, D. M. agreed to and did undergo a colonoscopy on April 23, 1996. As a result of the procedure, Dr. Magilen found and removed a 3 millimeter benign sessile polyp5 and noted the presence of a small amount of diverticuli in her sigmoid colon.6 The sigmoid colon, which makes up the last portion of the colon and attaches to the rectum, is so-named because of its "S" shape. The sigmoid colon is more mobile and, therefore, has more variability in its position. It is, however, usually located on the lower left side of the abdomen. Diverticuli are "out-pockets" or bulges in the intestine. Their presence is referred to more specifically as "diverticulosis." In adults over the age of 65 years, approximately 75% have diverticuli somewhere in the colon. A finding of diverticulosis in older adults is, therefore, not an uncommon finding. D. M. next presented to Dr. Magilen on July 14, 1997. She was 68 years of age. She complained of upper and lower abdominal pain, a change in bowel habits, occasional bright red blood from her rectum, and nausea (without vomiting). The abdominal pain, which she reported had started approximately a week and a half prior to July 14th, was reported to be mainly in the upper abdomen. D. M.'s change in bowel habits were reported to be constipation despite an increase from one bowel movement a day to four to five bowel movements per day. She was considered constipated, even with the increased number of bowel movements, because she had also reported a sensation of incomplete evacuation, that her stool consisted of hard balls, and she had witnessed bright red blood on occasion. Dr. Magilen obtained D. M.'s medical history and conducted a physical examination on July 14th. D. M.'s pertinent medical history included the following: (a) she was a heavy smoker for 26 years (3 1/2 packs a day until she quit in 1981); (b) she consumed alcohol regularly (at least 3 glasses of wine per day); (c) she had previous lumpectomies of her breasts for benign tumors; (d) she had a cavernous hemangioma on her right thigh that was treated with radiation therapy and for which she suffered a recurrence and malignancy; (e) she had cancer removed from her toe; (f) she had several D & C's of her uterus; (g) she had a sessile polyp removed from her colon in 1996; and (h) she has diverticulosis. Dr. Magilen's physical examination of D. M. revealed that she had diffuse, non-localized abdominal tenderness with no masses or organomegaly. A vaginal and rectal examination of D. M. revealed uterine tenderness with no masses. An anoscopic examination of her rectum revealed internal hemorrhoids. Dr. Magilen found no indication of acute blood loss or bowel obstruction, and no signs, symptoms, or indications of acute decompensation from a colonic malignancy. Dr. Magilen's impression of D. M. on July 14th was that she was suffering from acute abdominal pain and that uterine pathology needed to be ruled out as the source of her problem. Dr. Magilen, therefore, planned to obtain a pelvic ultrasound, admit D. M. to the hospital for 23 hours, and obtain a gynecological consult. The pelvic ultrasound, which was performed outpatient on July 14th, revealed the presence of an ovarian cyst on D. M.'s left ovary and no masses in her uterus.7 No other abnormalities, malignancies, or uterine pathology were revealed by the ultrasound. At approximately 4:30 p.m. of July 14th, D. M. presented and was admitted to Aventura Hospital. A blood chemistry profile, a complete blood count, abdomen X-rays, abdomen and pelvis Computed Axial Tomography ("CAT" or "CT") Scans and a gynecological consult with Dr. Gross, a gynecologist, were ordered. A complete blood count was also ordered for July 15, 1997. D. M. was placed on "NPO" (nothing by mouth), meaning that she was allowed no food or liquids by mouth. She was also given Vistaril, a common relaxant, to help with her complaints of pain. D. M. was not suffering from fever at the time of her admission. Her blood chemistry and the complete blood count failed to reveal any increase in her white blood cell count or an increase in immature white blood cells, commonly referred to as a "shift to the left." D. M. was found to be evidencing signs of anemia, based upon a drop in her hemoglobin. D. M.'s hemoglobin as of April 1996 had been 12.7. As of her admission to Aventura in July 1997, D. M.'s hemoglobin had fallen to 11.4. D. M.'s X-rays were unremarkable. No significant distention or the presence of free air, soft tissue masses, or abnormal calcifications were indicated. The CT Scan was produced on July 14, 1997. The image of the CT Scan was transmitted to an on-call radiologist, Dr. Maria Rodriguez, for a preliminary interpretation. Although Dr. Rodriguez issued a preliminary fax report of her findings, Dr. Magilen did not receive the report. Dr. Magilen was, therefore, unaware of the findings made by Dr. Rodriguez when he made the decision at issue in this case. The CT Scan image was also reviewed by Karl Drehobl, M.D. Dr. Drehobl's findings and impressions were provided to Dr. Magilen in a written report. That written report was received and considered by Dr. Magilen. With regard to D. M.'s colon, Dr. Drehobl's report included the following findings and impression as a result of his review of the CT Scan image: . . . . THERE IS SIGMOID DIVERTICULOSIS PRESENT. THERE IS EVIDENCE OF SIGMOID WALL THICKENING. THERE IS INCREASED DENSITY IN THE REGION OF THE SIGMOID MESENTERY. NO DISCRETE FLUID COLLECTION OR ABSCESS IS NOTED. FINDINGS ARE SUGGESTIVE OF SIGMOID DIVERTICULITIS. NO FREE AIR OR FREE FLUID IS IDENTIFIED. THE REMAINDER OF THE BOWEL AND MESENTERY ARE NORMAL. IMPRESSION: FINDINGS SUSPICIOUS FOR SIGMOID DIVERTICULITIS. NO FREE AIR OR DISCRETE ABSCESS COLLECTION. . . . . Dr. Drehobl's findings8 were consistent with those reported by Dr. Rodriguez. Dr. Drehobl's finding of "increased density in the region of the sigmoid mesentery" meant that the fat adjacent to the colon was swollen or inflamed. Dr. Drehobl's finding of sigmoid wall thickening meant that there was an abnormal thickening of the wall of the colon and small bowel. Dr. Drehobl's impression of D. M., taking into account his findings from reading the CT Scan, the fact that there were diverticuli present in the same area, D. M.'s age, and her history of abdominal pain, was that there was a "strong possibility" that D. M. was suffering from "diverticulitis or inflammation of the diverticuli in that region." See page 20, lines 12-14, Petitioner's Exhibit 2. "Diverticulitis" is the inflammation of one or more diverticuli. The diverticuli become inflamed when an out-pocket becomes blocked. Fluid from the mucosal lining of the intestine becomes captured in the blocked out-pocket. Infection and/or inflammation then occurs. If untreated, in the later stages of diverticulitis, a blocked diverticuli can rupture into the pericolonic fat and/or form an abscess.9 CT Scans can be 85 to 90% accurate in diagnosing diverticulitis. Even so, the results of a CT Scan are only a guide, one of a number of tests available to the physician, which must be correlated by the treating physician with all the clinical findings concerning the patient, including the results of the physical examination, the patient's clinical symptoms and history, the results of other diagnostic tests, and the results of laboratory studies. Dr. Drehobl's findings and impression were, therefore, not dispositive. Dr. Magilen was required to take Dr. Drehobl's findings into consideration along with his clinical findings. Dr. Magilen, after speaking with Dr. Drehobl personally about his report, did just that. Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. This conclusion was based upon a number of factors: Dr. Drehobl did not find any of the more specific signs of diverticulitis which CT Scans can show such as marked edema around the colon, abscesses within the mesentery, or segmental thickening. Dr. Drehobl's findings of increased density in the region of the sigmoid mesentery and sigmoid wall thickening were equivocal findings. Persons with diverticulosis, which D. M. was known to have, almost consistently evidence some thickening of the wall of the sigmoid colon; Because the results of the CT Scan were equivocal, the findings, in addition to supporting an impression of diverticulitis, also supported an impression of a number of other disorders, in and outside the colon, which Dr. Magilen had not yet been able to rule out: inflammation in another organ, such as the appendix or an adjacent loop or intestine; inflammation in a fallopian tube or an ovary; colon neoplasm, colitis, or other tumor of the colon; ischemic colitis, Crohn's disease, and inflammatory bowel disease; D. M. was not evidencing the classic symptoms of diverticulitis: Left-lower quadrant pain; Fever; and Increased white blood cells and a "shift to the left." The presence or absence of any one or more of these symptoms alone does not reasonably support a finding of diverticulitis or the absence thereof. But the absence of all three significantly reduced the possibility that D. M. was suffering from diverticulitis; and D. M.'s symptoms, including rectal pain, bright-red rectal bleeding (which is less likely to occur with diverticulitis) associated with bowel passage, vague abdominal discomfort that was not localized to any particular quadrant of the abdomen, and her sensation of incomplete evacuation could not all be explained by diverticulitis and were suggestive of other diagnosis which Dr. Magilen had not been able to rule out. D. M.'s hemoglobin, which had dropped from 12.7 in April 1996 to 11.4 upon her admission to the hospital, indicated some loss of blood which her body was not able to replace, could also have been symptomatic of the other problems suggested by the results of the CT Scan. Based upon the foregoing, and following a consult with Dr. Gross, Dr. Magilen's impression was that D. M.'s pathology was coming from her uterus and ovarian tubes. Between the evening of July 14, 1997, and the morning of July 15, 1997, D. M.'s condition improved. She exhibited minimal abdominal tenderness, she had a normal white blood cell count, she had no fever, and she was able to eat. Dr. Magilen decided to increase her diet and to discharge her home with directions to follow-up with Dr. Magilen and her gynecologist. Dr. Magilen prescribed Cipro, a broad spectrum antibiotic, to address what he believed was her pelvic inflammatory process. The day after she was released from the hospital, July 16, 1997, D. M. presented to Dr. Eisman. She complained that the abdominal pain had returned during the night of July 15th. Dr. Eisman conducted a physical examination of D. M. Dr. Eisman found an increase in pain on palpation of the cervix and generalized mild tenderness of the abdomen. Because the pain in D. M.'s abdomen was not located in the lower left- quadrant and in light of the pain on palpation of her cervix, Dr. Eisman was of the opinion that the likely cause of her pain was pelvic inflammatory disease. The etiology of her pain was, however, still unknown. Dr. Eisman had D. M. readmitted to Aventura and notified Dr. Magilen of the change in her condition. D. M. was readmitted with orders for blood chemistry and complete blood count, ultrasound of the pelvis, X-rays of the abdomen, CT Scan of the abdomen and pelvis, and NPO (except ice chips). She was given Phenergan and Demerol for pain and nausea. Dr. Magilen examined D. M. upon her admission to the hospital. He found that her abdomen was soft with minimal tenderness. A vaginal and rectal examination revealed uterine tenderness with no masses. These findings were consistent with those of Dr. Eisman and Dr. Gross. D. M. was still not experiencing fever. Flat and upright X-rays of D. M.'s abdomen revealed no significant abnormalities. D. M.'s blood chemistry studies and complete blood count indicated the presence of anemia, a significantly elevated sedimentation rate with no increase in white blood cell count and no "shift to the left." The CT Scan revealed some evidence of diverticulosis and slight edematous changes within the fat adjacent to the sigmoid colon consistent with diverticulitis. Dr. Magilen again discussed the CT Scan findings with the radiologist. Dr. Magilen was still concerned about those findings for most of the reasons indicated in Finding of Fact 41, supra. The radiologist's findings were still equivocal; the findings were still consistent with other disorders, which the radiologist acknowledged to Dr. Magilen, including a carcinoma or other inflammatory process inside or outside the colon; D. M. was not evidencing the three classic signs of diverticulitis; and her symptoms continued to support other findings. The ultrasound of D. M.'s pelvis was performed on July 17, 1997. The following findings and impressions were made as a result of the ultrasound: . . . . THERE IS A FIBROID LESION WITHIN THE LOWER UTERINE SEGMENT ADJACENT TO THE CERVIX MEASURING 2.7 X 2.3 X 2.6 CM. NORMAL ENDOMETRIAL STRIPE IS NOTED. NO ADDITIONAL UTERINE MASSES ARE NOTED. BOTH OVARIES ARE UNREMARKABLE IN APPEARANCE. THE RIGHT OVARY MEASURES 1.6 X .9 X 1.1 CM AND THE LEFT OVARY MEASURES 1.8 X 1 X 1 CM. NO ADNEXAL MASSES ARE NOTED. SMALL AMOUNT OF FREE FLUID IS NOTED WITHIN THE CUL-DE-SAC. IMPRESSION: LOWER UTERINE FIBROID LESION MEASURING 2.7 X 2.3 X 2.6 CM. NO ADNEXAL MASSES. SMALL AMOUNT OF FREE FLUID. The July 17, 1997, ultrasound found that the cyst which had been disclosed by the July 14, 1997, ultrasound was now gone. This fact, coupled with the fluid found in D. M.'s cul-de-sac (located in the rectal-uterine space, between the rectum and the posterior wall of the uterus and the vagina), could mean that the cyst had ruptured. The ultrasound also indicated that the uterus was 20 percent larger and that there was a two to three centimeter myoma or tumor in the lower uterine segment. These changes, which apparently took place over a two to three day period, and the results of D. M.'s physical examination (uterine tenderness and tenderness in the cul-de-sac), are consistent with pelvic inflammatory disease. The findings of the July 17, 1997, ultrasound could also explain the findings of edema and the change in sigmoid mesentery found by the CT Scan. Both Dr. Gross10 and Dr. Magilen concluded that it was likely that D. M. was, at least in part, exhibiting signs of pelvic inflammatory disease. Dr. Gross also concluded that, if her condition did not soon improve, a laproscopy11 would probably be required to determine the specific cause of D. M.'s complaints. Dr. Magilen was still concerned about the possibility of colon cancer or some other colonic disorder which the CT Scan and the ultrasound did not explain. Dr. Magilen's concern was based upon the following factors, which his conclusion about pelvic inflammatory disease and the CT Scans of July 14th and July 16th had not ruled out: The findings of the CT Scans and the impressions of the radiologists concerning diverticulitis had not ruled out the possibility that D. M. was suffering from some other colonic disorder, as explained in findings of fact 41 and 52; D. M. had undergone at least some treatment with antibiotics upon her release from the hospital on July 15th and undergone some bowel rest while in the hospital between July 14th and July 15th, and yet her complaints had persisted; and D. M.'s history (she is at some risk of cancer) and her complaints: she had unexplained or undefined abdominal and pelvic pain that had lasted for a week or two; she had been bleeding from the rectum and had rectal pain; she had had a change in her bowel pattern; and she had shown signs of anemia. Dr. Magilen decided to perform a colonoscopy on D. M. to be sure that D. M. was not suffering from a colonic disorder in addition to what he suspected was a pelvic inflammatory disease. The procedure was performed on July 18, 1997. It was performed easily and without apparent complication at the time. Dr. Magilen found uncomplicated diverticulosis but no other pathology, including colonic neoplasm, lesions, or malignancy. Subsequent to the completion of the colonoscopy on July 18th, D. M.'s condition rapidly deteriorated. D. M. experienced an acute abdomen, which is consistent with a possible perforation of the colon as a result of the colonoscopy. An abdominal X-ray, however, failed to reveal a perforation or the presence of free air in D. M.'s abdomen. D. M.'s condition did not improve on July 19th. Therefore, on July 20, 1997, Dr. Magilen performed exploratory surgery on D. M.'s abdomen. Dr. Magilen observed inflammation and abscesses on the outside of D. M.'s colon. Dr. Magilen also reported observing two perforations of her sigmoid colon. Dr. Magilen also found inflammation of the right ovary and tube and the presence of pus in the cul-de-sac. The pus was sampled for culture. Because of the two perforations Dr. Magilen believed he had observed, Dr. Magilen removed a large portion of the colon; he resected and placed a colostomy. Pathology of the resected portion of D. M.'s colon determined that the colon evidenced focal fibrinous hemorrhagic exudate, numerous deep diverticuli, and no neoplasm. Culture of the pus did not produce bacteria that would be expected from ruptured diverticuli. The culture was, however, consistent with a gynecologic origin. Pathology also failed to confirm Dr. Magilen's belief that there were two perforations in D. M.'s colon. These findings suggest that D. M. was suffering from a pelvic inflammatory disease, in particular, a tube and ovary on the right side; and that the inflammation may have adhered the tube and ovary to the sigmoid colon causing the symptoms evidenced by D. M. as opposed to diverticulitis. Conducting a colonoscopy in a patient with diverticulitis is generally considered counterindicated and may under certain circumstances constitute a deviation from the standard of care. A colonoscopy is counterindicated because it poses a greater risk of perforation by mechanical trauma-- disruption of the inside of the bowel wall by the scope used to perform the colonoscopy--for a patient suffering from diverticulitis. The colonoscopy also requires the injection of air into the colon which results in the colon being firmer and, thus, more prone to damage, especially if the patient is suffering from diverticulitis. A perforation of the colon can result in serious complications and can lead to death. Under normal circumstances, the preferred treatment of diverticulitis is to prescribe antibiotics, serial clinical examinations, and bowel rest. Absent some reasonable basis for deviation, the most prudent treatment of a patient suffering from acute diverticulitis who may also be suffering from a colonic disorder would be to treat the patient for the diverticulitis first and then, if deemed medically necessary, perform a colonoscopy after the diverticulitis has been resolved. Usually, the four to days it takes for antibiotics to be effective in treating diverticulitis, will not make any difference in a patient's oncologic situation. Even where it is suspected that there is another pathology in the colon, it may be prudent to calm the bowel and address the diverticulitis first before performing a colonoscopy. Despite the foregoing, if it is questionable whether a patient is in fact suffering from diverticulitis as opposed to some other process, the need for additional information concerning the patient must be weighed against the risk of performing a colonoscopy. Under these circumstances, clinical judgment concerning whether the colonoscopy should be performed must be exercised. The evidence in this case failed to prove that Dr. Magilen did not have a reasonable basis for proceeding with a colonoscopy of D. M. on July 18, 1997, despite the "suspicion" of diverticulitis reported as a result of the CT Scans of July 14th and July 16th. The normal course of treatment for diverticulitis was not followed in D. M.'s case by Dr. Magilen because Dr. Magilen was not convinced that D. M. was suffering from diverticulitis. As found, supra, Dr. Magilen concluded that D. M.'s clinical picture was unclear at best. In light of D. M.'s unclear clinical picture and Dr. Magilen's conclusions concerning the CT Scan findings, the evidence failed to prove that Dr. Magilen failed to realize that D. M.'s history, physical examination, and radiologic studies were consistent with a diagnosis of probable diverticulitis. In addition to D. M.'s unclear clinical picture and Dr. Magilen's reasonable conclusions concerning the CT Scan findings, Dr. Magilen was faced with the knowledge that Dr. Gross would in all probability perform a laproscopy on D. M. It was, therefore, reasonable for Dr. Magilen to proceed with the colonoscopy on July 18th without first treating D. M. with antibiotics and bowel rest. Dr. Magilen reasonably decided that it would be better to determine if there was any colonic disorder before the laproscopy was performed. Dr. Magilen wanted to avoid D. M. being placed under a general anesthesia and having some surprise problem with her colon discovered after the laproscopy was begun. The evidence, therefore, failed to prove that Dr. Magilen failed to practice medicine with the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances because Dr. Magilen failed to treat D. M. for diverticulitis with intravenous antibiotics and serial clinical examinations before performing the colonoscopy on July 18, 1997. Finally, the evidence failed to prove that Dr. Magilen failed to document justification for proceeding to perform a colonoscopy on D. M. on July 18, 1997.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered dismissing the Administrative Complaint against Steven A. Magilen, M.D. DONE AND ENTERED this 29th day of October, 2001, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 29th day of October, 2001.
Findings Of Fact Respondent is a lay midwife licensed by the state of Florida. She has practiced as a licensed lay midwife in Florida since 1981. Respondent began her training in Boston, Massachusetts, in 1975 when she began participating in an apprenticeship program under the supervision of two Board-certified obstetricians. That training lasted for three years and included self-study, seminars, and workshops. As part of that apprenticeship program, Respondent delivered one hundred babies under the supervision of those physicians. After moving to Florida, Respondent obtained her license as a lay midwife after attending fifteen births under the supervision of a physician and after taking a written and oral examination. Since being licensed in Florida, Respondent has attended and graduated from the South Florida School of Midwifery. She has subsequently been a preceptor and instructor at that School and is on the Board for the School. At the time of the final hearing in this cause, Respondent was only two months away from receiving her nursing degree. Respondent is a member of the Midwives Association of Florida. During the course of her licensure in Florida, Respondent has attended all types of continuing education programs, particularly in the field of maternal and child health. While licensed in the state of Florida, she has attended between five hundred and seven hundred births, sometimes as the primary caregiver, sometimes assisting other midwives, and sometimes assisting physicians during hospital births. At all times material hereto, Respondent has maintained an ongoing relationship with Dr. Atilla Eagleman, an obstetrician and gynecologist. She frequently consulted with Dr. Eagleman, and he performed risk assessments on Respondent's patients. In other words, Dr. Eagleman was Respondent's "back-up" physician. Dr. Eagleman became Board-certified in December, 1990. When patient Sandy Freireich first consulted with Respondent on May 11, 1989, Freireich was seventeen to eighteen weeks pregnant with her fourth child. Respondent told Freireich that in order for her to be accepted as one of Respondent's patients, she needed to provide Respondent with proof that she had obtained an initial risk assessment by a physician. Freireich told Respondent that she had obtained that examination from her regular doctor who was an obstetrician and that she would bring Respondent a copy of her medical records documenting that examination on her next visit. Since Respondent performs an initial risk assessment on her patients, she did so with Freireich and determined that she was a low-risk patient. On at least seven occasions, Respondent told Freireich that Freireich had to provide Respondent with a copy of the initial risk assessment records from Freireich's physician. On each occasion Freireich promised to provide such a record. Respondent also strongly encouraged Freireich to see Dr. Eagleman and have him perform an initial risk assessment. Freireich agreed to do so. Respondent also requested permission from Freireich to allow Respondent to obtain Freireich's records directly from Freireich's doctor by having Freireich sign a medical records release form. Freireich insisted that she wanted to speak to her physician to make sure her doctor understood rather than simply sending him a form to release her records. Along the way Freireich missed several appointments with Respondent. For those appointments which she kept, she failed to bring with her the promised documents. On September 6, 1989, when Freireich was 32.4 weeks pregnant, she signed a medical release form authorizing Respondent to obtain her medical records directly from her doctor. On that visit, Respondent recommended to Freireich that she obtain her third trimester risk assessment from Dr. Eagleman. On September 14, 1989, Respondent received records directly from Freireich's obstetrician. Those records did not contain an initial risk assessment for Freireich's current pregnancy. On September 20, 1989, when Freireich was 34.4 weeks pregnant, Respondent caused Freireich to receive a risk assessment and a physical and prenatal examination by a certified nurse midwife in Respondent's office. That risk assessment also revealed that Freireich was a low-risk patient. It is unknown whether Freireich ever obtained an initial risk assessment during her first twenty-eight weeks of pregnancy. It is uncontroverted, however, that Respondent never received proof of such an initial risk assessment by a physician or by a certified nurse midwife. Furthermore, it is clear that Respondent consistently encouraged Freireich to obtain an initial risk assessment by a physician, and that it was Freireich who failed or refused to provide proof that such had been performed. In 1987 the Department proposed a number of changes to the rules regulating the practice of midwifery. The Florida Midwives Association challenged the proposed rules, and the Association and the Department engaged in a long-term dialog thereafter. New rules did not become effective until 1991. Although there were existing rules in place during that interim period, it became a common practice for midwives to contact Anne Richter, a consultant for the Department's midwife program. Based upon the information provided to her by a midwife, Richter would tell the midwife to care for a particular patient pursuant to the existing rules or pursuant to the proposed rules. It was common knowledge among the midwives in the state of Florida that the Department was informally allowing midwives to practice under the proposed rules rather than the existing rules and that one could call Anne Richter to obtain a "waiver" of rule requirements. On one occasion, Respondent had telephoned Richter regarding a patient who had come to Respondent when she was thirty weeks pregnant and had not obtained an initial risk assessment during her first twenty-eight weeks of pregnancy. Richter told Respondent that it was permissible for Respondent to accept that patient whose only risk factor was starting care after twenty-eight weeks. Respondent did not accept that patient. Although Respondent had intended to telephone Richter to seek permission to continue providing care to Freireich, Respondent neglected to do so. On October 30, 1989, Freireich left a message cancelling her appointment for that day. Later that afternoon she contacted Respondent to advise Respondent that she was in labor. She declined to allow Respondent to come to Freireich's home until after 8:30 p.m. because she wanted her other children to be asleep before Respondent got there. Respondent arrived at the Freireich home at 8:50 p.m. She assessed Freireich's labor, performed a physical examination, and began attending to Freireich's needs during labor. At 11:30 p.m., the fetal heart rate was 150. The patient took a shower. When she finished her shower at 11:50 p.m., Respondent checked the fetal heart rate and found that it had decreased to 90. Respondent appropriately instructed the patient to lay on her left side and gave her oxygen at six liters since the deceleration in the heart rate may have been indicative of a problem that needed to be rectified. At 11:53 p.m., Respondent appropriately checked the fetal heart rate and again found that it was 90. Respondent then assessed the patient and found the patient to be fully dilated with the baby at between 0 and +1 stations. Since the patient was fully dilated, Respondent instructed her to push. Respondent again checked the fetal heart rate and found that it had decelerated to 60. That the patient had a history of having rapid deliveries and was a multipara (had previously had one or more viable births) was significant in that it was very likely that with good expulsive efforts the baby would be delivered in a short time. Respondent was concerned when she got the decelerated fetal heart rate but believed birth to be imminent. An experienced birth practitioner can judge whether delivery will be expeditious. At 11:58 p.m. the baby was at the +2 station (half the way down the birth canal, i.e., half way out). The fetal heart rate was 60 when Respondent again checked. Respondent's extensive training and experience had made her aware that it was not unusual to encounter a decelerated fetal heart rate directly prior to birth. A deceleration of the fetal heart rate at the final stage of labor can result from "head molding," and the rotation of the baby. In other words, it is very common to have a fetal heart rate drop due to head compression and the transverse lie of the head during the final stages of delivery. In 98% of those cases, the decelerated fetal heart rate will return to base line. In Respondent's previous experience, babies who had similar deceleration in their heart rate came out vigorous and robust, or may have needed a little tactile stimulation or warmth to be resuscitated, but always came out normal. Her training dictated that the proper procedure was to assess whether delivery was imminent. Respondent knew that a heart rate of 60 sustained for a few moments with no progress would be considered an emergency situation necessitating physician consultation or contacting emergency medical services for transportation to a hospital. On the other hand, a fetal heart rate of 60 sustained for a few moments with progress was not unusual, and the best course of action was to facilitate delivery of the baby. Since her patient was having strong contractions, was making good expulsive efforts, and the baby was descending rapidly down the birth canal, Respondent knew that birth was imminent. Exactly twelve minutes after the patient came out of the shower, the baby was delivered. The baby was stillborn. Respondent had no indication prior to the delivery of the baby that the baby would be severely compromised or dead. Respondent is fully trained in resuscitation of babies. She is certified in medical CPR, has taken many continuing education courses in emergency procedures, and is certified in and carries with her the equipment necessary for neonatal resuscitation: neosuctioning, an Ambu Bag, and oxygen. When the baby was delivered at 12:02 a.m., Respondent caused one of the adults present to contact fire rescue. Respondent immediately began resuscitation efforts and continuously attempted to resuscitate the baby until the fire rescue unit arrived, which was fifteen minutes after fire rescue was called the first time. Between the first decelerated fetal heart rate and delivery of the baby twelve minutes later, Respondent did not refer the patient to a physician or consult with Dr. Eagleman because to do so would have taken time away from managing a potentially dangerous situation and because she knew that Dr. Eagleman would merely tell her to get the baby delivered. Further, Respondent did not consider the drop in the heart tones to be abnormal requiring her to refer the patient to a physician since there was rapid progress and birth was imminent. Dr. Eagleman verified during the final hearing in this cause that had Respondent contacted him during the twelve minutes in question to report the decelerated heart rate, he would have told her to get off the telephone, go back to her patient, and "get the baby out." Respondent had never previously delivered a stillborn. There is no suggestion made in this record either that Respondent should have known that the baby would be stillborn or that Respondent contributed in any way to cause that unfortunate outcome. Respondent contacted Anne Richter to advise her what had happened and subsequently sent written reports to Richter detailing her care of patient Freireich. Petitioner has never before taken disciplinary action against Respondent.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered Finding Respondent guilty of violating Rule 10D-36.042(1), Florida Administrative Code (1989); Finding Respondent not guilty of violating Rule 10D-36.46(4)(e), Florida Administrative Code (1989); Finding that no disciplinary action should be imposed because the violation was neither willful nor repeated; and Dismissing the Notice of Formal Reprimand filed in this cause. DONE and ENTERED this 31 day of March, 1992, at Tallahassee, Florida. LINDA M. RIGOT Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 SC 278-9675 Filed with the Clerk of the Division of Administrative Hearings this day of March, 1992. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 91-1953 Petitioner's proposed findings of fact numbered 1, 2, 7, 8, 15 and 16 are adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 3-6, and 9-14 are rejected as not being supported by the weight of the competent evidence in this cause. Respondent's proposed findings of fact numbered 1-9, 12, 13, 15, 19-33, and 35-39 are adopted either verbatim or in substance in this Recommended Order. Respondent's proposed finding of fact numbered 10 is rejected as not being supported by the weight of the competent evidence in this cause. Respondent's proposed finding of fact numbered 18 is rejected as being subordinate to the issues herein. Respondent's proposed findings of fact numbered 11, 14, 16, 17, 34, and 40 are rejected as not constituting findings of fact but rather as constituting argument of counsel, conclusions of law, or recitation of the testimony. COPIES FURNISHED: Karen Miller, Esquire District IX Legal Counsel Department of Health and Rehabilitative Services 111 Georgia Avenue West Palm Beach, Florida 33401 Thomas G. Sherman, Esquire 218 Almeria Avenue Coral Gables, Florida 33134 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
