The Issue The issue in this case is whether Petitioner’s claim for medical treatment by Dr. Gutovitz should be paid under the terms of her state health insurance plan.
Findings Of Fact Petitioner was, at all times relevant hereto, an employee of the State of Florida, receiving medical benefits under the State Employees’ HMO Plan (the “Health Plan”). In January 2015, Petitioner contacted North Florida OBGYN Associates, P.A. (the “Doctor’s Office”), to schedule a doctor’s appointment. A computer screenshot provided by the Department indicates that the purpose of the appointment was to “discuss infertility/endometriosis.” An appointment was scheduled for March 22, 2015. Upon arrival at the Doctor’s Office, Petitioner filled out an intake sheet. She stated the purpose of her visit was for the problems of “endo & checkup.” She indicated that she was not currently using birth control. As part of her medical history, she indicated: migraine headaches, reflux/IBS/ulcer, endometriosis, and infertility. Upon completion of his examination and treatment of Petitioner, Dr. Gutovitz dictated his “History & Physical Report” notes on the visit. He stated as follows: The patient is a 29 year old female who presents for a preconceptual consultation. LMP date: (2/25/2015) The frequency of cycles is monthly. The duration of menses is less than 3 days. The menstrual flow is moderate. The patient has never been able to conceive. The patient has been unable to conceive after 2 years of unprotected intercourse. Intercourse has been occurring twice per week. There has been associated abdominal pain, pain on intercourse, breast tenderness (only when she is on her period) and cramping (only in the morning and then will go away). Vitamin and mineral intake: currently on prenatal vitamins (taking Women’s one a day, vitamin b-12, vitamin d, calcium). Nutrition: normal /adequate. Unknown. There is a medical history of endometriosis dx at the 20 by Dr. Samuel Christian). Pt. presents to discuss conception. She and her partner have been trying to [get] pregnant for 2 years. She reports at age 21 she had a laparascopy for pain and was diagnosed with severe endometriosis and advised to have a hysterectomy. She had no follow up treatment, was not put on OCP. She continue to pain with menses, with intercourse and sometimes throughout the cycle. She does have regular cycles about 28 days apart. The partner has never had any children. He did have an injury to his scrotum about 7 years ago (fell off a truck onto some sharp object that “ripped open my scrotum in an L shape”), had stitches, significant swelling. Discussed components of conception –- ovulation, pathway and semen. Referral to the FIRM [Florida Institute of Reproductive Management] for SA [sperm analysis], and recommended consultation with Dr. Freeman. Suggest laparascopy. CPT for the pelvic pain. If covered by insurance, encouraged patient to have surgery done with Dr. Freeman. However, if not covered (if considered fertility intervention), would be happy to perform this surgery. Discussed fertile time in cycle, timing and frequency of intercourse. Brief review of fertility interventions. Pt happy with this information, will proceed to AS and schedule consultation with Dr. Freeman. Also discussed patient’s weight. Discussed healthy diet and exercise. Pt considering gastric sleeve procedure. Discussed some of the pros and cons of this being performed before or after fertility intervention. Pt likely to postpone surgery at this point. Dr. Gutovitz listed “Infertility, Female” as the diagnosis. The plan of treatment called for the patient to “Follow up with reproductive endocrinologist.” There is no mention of treatment for endometriosis. It is clear from Dr. Gutovitz’s notes that the purpose of the visit was to discuss infertility. Although endometriosis was mentioned, it was merely in a medical historical context. Following her visit to the Doctor’s Office, Petitioner made an appointment with Dr. Freeman (as advised by Dr. Gutovitz during the March 22 visit). She visited Dr. Freeman’s office on April 15, 2015. Dr. Freeman’s intake sheet on the patient indicates the chief complaint as “Primary infertility, endometriosis/pelvic pain.” Dr. Freeman discussed the infertility issue, but noted “[Petitioner] is interested in further evaluation and treatment but most interested in control of her pelvic pain.” Nonetheless, he noted that Petitioner’s husband would undergo a semen analysis to determine his fertility potential. About a week later, Petitioner presented again to Dr. Freeman for a follow-up visit. The doctor again addressed and discussed her pelvic pain and how it might be treated. He noted, “[Patient] is completely self-pay for fertility treatment and wishes to defer on HSG currently to see if tubal patency exists.” He concludes his notes on that visit with: At this point in time, [Petitioner] will forward results of her primary care physician’s lab work over to our office. Once this occurs, we will meet for reconsultation and likely undergo several cycles of empiric ovulation induction as a first step. If she does not become pregnant with that, then we will likely perform HSG to evaluate for tubal patency and consider the possibility of surgery. At the conclusion of the visit, they were understanding of the above, in agreement with the plan and rationale and had no additional questions or concerns. Empiric ovulation induction is a fertility treatment that induces ovulation. An HSG procedure uses dye to assess whether the fallopian tubes are blocked, i.e., whether there is tubal patency. Again, the doctor’s notes and comments address Petitioner’s endometriosis and pelvic pain, but his primary focus is on the infertility issue. Petitioner contends the two physicians simply misunderstood her needs or made a mistake when coding her office visits. The preponderance of evidence does not support her contention. Petitioner’s testimony concerning her claim was not persuasive. The Health Plan under which Petitioner was insured contains an exclusion of payment for infertility treatments. Section VI, Limitations and Exclusions, of the State Employees’ HMO Plan specifically excludes payment for “infertility treatment and supplies,” including testing, diagnostic procedures, and treatment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Management Services denying Petitioner's claim for reimbursement of payments relating to her medical treatments by Dr. Gutovitz. DONE AND ENTERED this 7th day of March, 2016, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN 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 7th day of March, 2016. COPIES FURNISHED: Nesha Butterfield 2545 Chesterbrook Court Jacksonville, Florida 32224 Gavin D. Burgess, Esquire Department of Management Services Suite 160 4050 Esplanade Way Tallahassee, Florida 32399-0950 (eServed) J. Andrew Atkinson, General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 160 Tallahassee, Florida 32399-0950 (eServed)
The Issue The issue in this case is whether disciplinary action should be taken against Respondent's license to practice medicine in the State of Florida, for committing the violations alleged in an Administrative Complaint entered March 26, 1996.
Findings Of Fact Petitioner, the Agency for Health Care Administration, is an agency of the State of Florida charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, and Chapters 455 and 458, Florida Statutes. Respondent, Brian Hardcastle, M.D., is a licensed physician in the State of Florida. Dr. Hardcastle was licensed by the State of Florida at all times relevant to this proceeding. Dr. Hardcastle was issued license number ME 0015980. On or about August 27, 1991, D.C. presented to Dr. Hardcastle with complaints of headaches. D.C. is a female. In August of 1991, D.C. was twenty years of age and was taking birth control pills. Dr. Hardcastle diagnosed D.C. as suffering from rhinitis, with a secondary diagnosis of a deviated nose and septum. Rhinitis is an inflammation of the mucous membrane. There are two major categories of rhinitis: (a) allergic rhinitis; and (b) non-allergic or vasomotor rhinitis. Dr. Hardcastle followed a course of treatment that first ruled out allergic rhinitis. Dr. Hardcastle failed to adequately assess D.C.'s complaint when he failed to take into account the fact that D.C. was taking birth control pills. Dr. Hardcastle failed to consider the possibility that D.C. was suffering from vasomotor rhinitis as a result of taking birth control pills. Dr. Hardcastle concluded that surgery was necessary. A second opinion from a Dr. Walker also recommended surgery. Dr. Walker only recommended that a septoplasty be performed. Septoplasty is a procedure whereby a deviation, thickening or abnormality of the septum, the partition in the middle of the nose, is corrected surgically. Dr. Hardcastle recommended that D.C. undergo a septorhinoplasty: septoplasty and rhinoplasty. Rhinoplasty is cosmetic and involves some reduction, thinning, or narrowing of the outer nose. A separate form describing each surgical procedure was provided to D.C. (see Respondent's exhibits 2 and 3), and a film (not offered into evidence) was provided to D.C. by Dr. Hardcastle. The evidence failed to prove that the description of the types of procedures to be performed on D.C. were not adequate or that D.C. was not adequately informed on the possible results of the rhinoplasty procedure. The evidence also failed to prove that Dr. Hardcastle failed to keep adequate medical records of his explanation of the procedure to D.C. The surgery recommended by Dr. Hardcastle was performed on D.C. by Dr. Hardcastle on December 19, 1991. During the surgery Dr. Hardcastle removed approximately 1 inch x 1/2 inch of cartilage. Dr. Hardcastle also performed an osteotomies or the separation of the nasal bone, which according to Dr. Hardcastle's notes, was to correct a minor tilting of the nose to one side. The procedure performed by Dr. Hardcastle was poorly planned, and did little, if anything, to address the problems for which D.C. had first presented to Dr. Hardcastle. Following surgery, D.C. experienced difficulty breathing. She returned to Dr. Hardcastle from December of 1991 until May of 1992 in an attempt to get the problem corrected. Dr. Hardcastle addressed D.C.'s problem breathing by prescribing antihistamines and suggesting that the problem was allergies, even though Dr. Hardcastle had already concluded that D.C. was not suffering from any significant allergies. A reasonably prudent physician should have recognized that the procedure Dr. Hardcastle had performed on D.C. had not been effective and that she was suffering from a septum that was more deviated, or that had redeviated, or was obstructed. Dr. Hardcastle failed to discover this problem. D.C. ultimately presented to an allergist who determined that her septum was deviated or obstructed. It was subsequently determined that a bone spur on D.C.'s septum had not been removed by Dr. Hardcastle. The bone spur was removed during a second operation performed by another physician, Dr. Groff, in December of 1992. Based upon the foregoing, it is concluded that Dr. Hardcastle failed 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 in that he failed to consider the possibility that D.C. was suffering from vasomotor rhinitis as a result of taking birth control pills, his treatment of D.C. was poorly planned, and did little, if anything, to address the problems for which D.C. had first presented to him, and he failed to provide adequate postoperative treatment and care. It is also concluded that Dr. Hardcastle failed to keep adequate medical records in that he failed to note that D.C. was taking birth control pills. Dr. Hardcastle has one prior disciplinary action. On August 8, 1992, Dr. Hardcastle received a reprimand, was required to pay an administrative fine and he was prohibited from practicing otolaryngological surgery. See the Final Order in DRP Case Nos. 90-2824 and 90-4978.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Board of Medicine enter a Final Order finding that Respondent, Brian Hardcastle, M.D., committed acts prohibited by Sections 458.331(1)(m) and (t), Florida Statutes. It is further RECOMMENDED that the Board of Medicine impose the following penalties on Dr. Hardcastle: (1) an administrative fine in the amount of $5,000.00; (2) a reprimand; (3) probation for a period of two years; and (4) a permanent restriction on Dr. Hardcastle's license prohibiting him from performing surgery. DONE and ENTERED this 30th day of October, 1996, in Tallahassee, Florida. LARRY J. SARTIN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 30th day of October, 1996. COPIES FURNISHED: Albert Peacock, Esquire Joseph S. Garwood, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Brian Hardcastle, M.D. 6604 Southwest 35th Way Gainesville, Florida 32608 Douglas M. Cook, Director Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Jerome W. Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
The Issue Whether Respondent failed to timely file its application for the renewal of its abortion clinic license, as alleged in the Administrative Complaint. If so, may the Agency for Health Care Administration (Agency) fine Respondent for failing to timely file its renewal application. If the Agency is authorized to impose such a fine, should it exercise such authority. If so, what is the amount of the fine it should impose.
Findings Of Fact The Agency issued an administrative complaint on June 3, 1996, stating an intent to impose an administrative fine in the amount of One Thousand ($1,000.00) Dollars against A Doctor's Office for Women North, Inc., d/b/a A Doctor's Office for Women North (hereinafter referred to as "Respondent"), charging violations of Chapter 390, Florida Statutes, and Rule 59A-9, Florida Administrative Code, as grounds for the imposition of the administrative fine and advising the Respondent of its right to request an administrative hearing. Respondent was served a copy of the administrative complaint on June 4, 1996, by U.S. Certified Mail, Return Receipt Requested, but failed to respond or request a hearing within twenty one (21) days of receipt of notice of the action of the Agency as required pursuant to Section 120.57, Florida Statutes, and Rule 10-2.36, Florida Administrative Code. Respondent is licensed to operate at 1100 N.E. 125th Street, North Miami, Florida 33161, as an abortion clinic in compliance with Chapter 390, Florida Statutes, and Chapter 59A-9, Florida Administrative Code. Respondent has operated such that: (a) The Respondent has violated the provisions of Chapter 390, Florida Statutes, in that License Number 685 was issued to the Respondent for the period of 2/28/95 through 2/27/96. Respondent's application for renewal was due to be received by the Agency on 12/29/95, sixty days prior to expiration; however, it was received on 02/26/96, which was (54) days late. This is in violation of Section 390.016(1), Florida Statutes. Notice was provided in writing to the Respondent of the violations set forth above in paragraph 4(a).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency issue a final order dismissing the Administrative Complaint against Respondent. DONE AND ENTERED this 9th day of October, 1997, in Tallahassee, Leon County, Florida. STUART M. LERNER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 9th day of October, 1997.
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. He holds License No. ME 0019700. Respondent received his medical degree overseas and did his residence in obstetrics and gynecology at Bayfront Medical Center in St. Petersburg, Florida. He is neither board certified nor board eligible. For the past eight plus years Respondent's practice has been limited to terminating pregnancies at All Women's Health Clinic at Tampa, Florida. He has performed in excess of 15,000 abortions. One reason given by Respondent for so limiting his practice is the cost of medical malpractice insurance. Since he has no private practice, Respondent gave up admitting privileges at hospitals in the area. Without malpractice insurance, he would not be given staff privileges. On August 23, 1986, A. L., a pregnant 16 year old, entered All Women's Health Center, Tampa, to have her pregnancy terminated. A. L. had noted on her history statement that her last menstrual period started some eight weeks ago. Respondent first saw A. L. when he entered the procedures room at All Women's Health Center and commenced his examination prior to instituting abortion procedures. With respect to the examination the testimony varied widely. Diane Roberts, LPN, who was performing the duties of physician's assistant during the procedure, initially told the investigators that the examination lasted only a couple of seconds and consisted of a vaginal examination with two fingers of the right hand in the vagina while the abdomen was palpated with the left hand. At the hearing, Roberts testified that she wasn't paying much attention to the patient during the examination, didn't recall telling investigator the examination only took a couple of seconds, and recalled Respondent telling A. L. several times to relax. Respondent testified he performed a normal vaginal examination. The examination was longer than usual because A. L. wasn't relaxed and tensed her stomach muscles which made the uterus more difficult to palpate; and that following his examination he determined the gestational age of the fetus to be 12 weeks. Respondent testified he also checked the patient's heart and lungs before commencing the pelvic examination. A. L. testified that Respondent palpated her abdomen with two hands, but did not check heart and lungs or do a pelvic examination. A. L. had an earlier pregnancy terminated the previous year when the doctor did a pelvic examination with two fingers in the vagina while the abdomen was palpated with his other hand. The patient was ultimately determined to be 28 to 30 weeks pregnant. Largely because of the large error in gestational age, it is concluded that Respondent performed only a perfunctory examination on A. L. Had he conducted the proper examination, it is inconceivable that he, an experienced gynecologist, could underestimate the gestational age of the fetus by some four months. The magnitude of this error is illustrated by Respondent's testimony that a 12 week fetus is approximately 3 inches long and weighs 30 grams, while a 28 week fetus is approximately 14 inches long and weighs 1100 grams. Respondent started the procedure thinking he was aborting a 12 week fetus with the patient on the table and feet in the stirrups. After the instruments were inserted and the procedure started, Respondent concluded the fetus was 16 weeks, obtained a larger curette, then determined the fetus was more likely 20 weeks, again changed curette, and after removing fluid and part of an arm Respondent concluded that the gestational age of the fetus was some 28 weeks and required hospitalization to complete the procedure. Mistakes in determining gestational age can be made by a prudent physician if: (1) the patient is obese; (2) if the uterus is very soft and the extremities difficult to locate; (3) if the baby has a low fluid volume; (4) if the patient is very tense; or, (5) if the head of the fetus is felt and not the uterus. Here A. L. was more thin than obese which should have greatly facilitated palpation of the abdomen to determine the size of the uterus. Accepting the testimony that she was tense during the examination, and the earlier pregnancy would cause the uterus to be soft, no experienced gynecologist should conduct an examination of a patient such as A. L. and err on the magnitude here involved. Further, if the examination was difficult, the procedure should not have commenced until Respondent was reasonably positive of the gestational age of the fetus. One indication Respondent received that the fetus was older than 12 weeks was the quantity of fluid drawn. Further, no experienced gynecologist should mistake the head of the fetus as the extremity of the uterus on a patient such as A. L. Once Respondent determined the fetus was more than 16 weeks along, he called Dr. Barile, a gynecologist with admitting privileges at Humana Women's Hospital, Tampa, to request he remain available in case Respondent needed to send A. L. to a hospital. When Respondent determined the gestational age of the fetus' was more than 26 weeks, he again called Barile who suggested it would be better to refer the patient to an obstetrician. Respondent then telephoned his backup obstetrician and found she was on vacation, and a doctor with whom Respondent was not acquainted was taking her calls. Since A. L. was stable and in no apparent distress, Respondent called Dr. Klein, a pediatrician with admitting privileges at Bayfront Memorial Hospital in St. Petersburg. Dr. Klein agreed to take care of the patient by having his associate, who had the duty that day, meet the patient at Bayfront. A. L. had been brought to the clinic by her brother, and Respondent concluded A. L. could be safely transported to Bayfront by automobile and suggested her brother drive her. The brother demurred on the ground that his car overheated and might not make the 40-odd mile trip to Bayfront safely, but another brother had a more reliable car. The other brother was called and agreed to take his sister to Bayfront and stated that he would be at the clinic in about 10 minutes. Approximately 1 hour and 15 minutes later this brother arrived, and A. L. was started to the brother's car. At this time she appeared unsteady, and Respondent concluded she should go to Bayfront by ambulance. When a Hillsborough ambulance service was called, they told Respondent of the policy whereby they could not transport a patient out of Hillsborough County and that he should contact a Pinellas County ambulance service to perform the desired transportation. Respondent then called a Pinellas County ambulance service who arrived about an hour later to take A. L. to Bayfront where she was met by Dr. Yeshnick, the associate of Dr. Klein, who admitted the patient. Between the time Respondent determined the abortion could not be performed at the clinic until A. L.'s arrival at Bayfront Hospital, some 6 hours had elapsed. Of the approximately 15,000 abortions that Respondent has performed, less than 5 became emergencies that required removal from the clinic to a hospital. Respondent's backup procedures for emergencies were adequate. On August 23, 1986, A. L. was in the third trimester of her pregnancy, and the abortion was not necessary to save the life or preserve the health of A. L.
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 At issue in this proceeding is "[w]hether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate post-delivery period in a hospital," as required for coverage to be accorded under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact At or about 7:50 p.m., June 12, 1995, Ms. Fluet presented to Morton Plant Hospital in active labor. At the time, history revealed Ms. Fluet's estimated date of delivery as June 6, 1995, the fetus at 40 6/7 weeks gestation, spontaneous rupture of the membrane at 6:15 p.m., and the onset of regular contractions at 6:45 p.m. A physical examination by Cheryl Ewing, a certified nurse midwife (CNM) associated with the hospital's Nurse Midwifery Service, revealed the cervix to be 4 to 5 centimeters, effacement complete, and the fetus at station -1. Fetal heart tone (FHT) was noted in the 140-beat per minute range, reactive and contractions were noted at 1 1/2 to 2-minute intervals. Nurse Ewing's impression was "IUP [intrauterine pregnancy] term, active labor." Nurse Ewing admitted Ms. Fluet to labor and delivery under the hospital's nurse midwifery service protocol for an anticipated normal vaginal delivery, and managed her progress until approximately 8:00 p.m., when she was replaced by Carol Kitchen, CNM. At the time, John Brady, M.D., an obstetrician/gynecologist (OB/GYN), was on call, as supervising physician for the Nurse Midwifery Service to provide direct medical care (management) for any medical or obstetrical complication beyond the capabilities of the CNM (such as cesarean sections and forceps or vacuum extractions) and to consult with the CNMs by telephone, as needed. 1/ At the time of Ms. Fluet's labor and delivery, Dr. Brady was a "participating physician" in the Florida Birth- Related Neurological Injury Compensation Plan (the "Plan"); however, neither Cheryl Ewing nor Carol Kitchen were "participating physicians" since they had not paid the assessment required for participation in the Plan. Sections 766.302(7) and 766.314(4)(c), Florida Statutes. Moreover, Morton Plant Hospital was not a "teaching hospital," as that term is used in the Plan. Section 766.309(1)(b), Florida Statutes. 2/ The Morton Plant Hospital Nurse Midwifery Service Protocol (the "Protocol") provides the following definition of Nurse Midwifery Service: Nurse Midwives are employed by Morton Plant Hospital and function under the supervision of the attending OB/GYN physician. They are never independent practitioners and accept responsibilities delegated to them by the attending OB/GYN physician. As team members, the Nurse Midwives work in cooperation with the Medical Staff of the Hospital, Nursing Staff and community health personnel in planning for and providing comprehensive obstetrical care for the patient and her family throughout the maternity cycle. The Nurse Midwife, under the supervision of the attending OB/GYN consultant, will be responsible for the care of mothers and neonates (while in the Delivery Room) throughout the maternity cycle, obtaining consultation when indicated. The Nurse Midwife is prepared to make obstetrical value judgements within her role and to accept responsibility for managing obstetric care throughout the maternity cycle in association with the attending OB/GYN and Pediatric Physicians. She offers as well her special contributions of support and health education. The protocol includes the following labor and delivery policies: II. Admission Policies . . . Labor Room Policies The Nurse Midwife is responsible for managing patients during labor and delivery, and will document same on patient's medical record The Nurse Midwife: Will request a pelvic evaluation by physician whenever necessary during labor; Will request medical consultation and/or management for any medical or obstetrical complication; Will turn the patient over to medical management if she feels the condition of the patient is beyond her capabilities of managing . . . . * * * Pitocin Augmentation or Induction CNM will order IV Pitocin when indicated and consult with physician when necessary; Pitocin will be administrated according to OB/GYN Department Section Protocol; CNM will be present when Pitocin is begun and will be in the department after 4 cm of dilatation or active labor has been established. * * * B. [Sic] Second Stage Management . . . Delivery Management Physician will be called in to apply forceps or vacuum extraction if the need arises; Physician will be called to manage all breech deliveries; Physician will be called to manage all twin deliveries; CNM/physician will manage shoulder dystocia; CNM may manually remove placenta in the presence of hemorrhage. For retained placenta longer than 30 minutes without hemorrhage, the backup physician will be consulted. Under the protocol, the CNM may augment or induce labor with Pitocin with the approval of the supervising physician. Accord, Section 467.015(3), Florida Statutes. At 9:50 p.m., vaginal examination revealed no progress in labor (with the cervix still anterior lip occiput posterior, effacement complete, and the fetus at station +1) despite pushing for one hour. Lack of progress was attributed to hypotonic contractions (contractions of only 30 seconds duration, which were inadequate to expel the fetus), a condition frequently remedied by augmentation with Pitocin (to strengthen the contractions and rotate the head). Consequently, Nurse Kitchen telephoned Dr. Brady for consultation, explained the circumstances, and received authorization to augment labor with Pitocin. Such was the limit of Dr. Brady's participation in Nurse Kitchen's management of Ms. Fluet's labor and delivery. Labor was successfully augmented with Pitocin, and at 11:07 p.m., Tano Niles Jokela (Tano) was delivered. At delivery, meconium stained fluid was noted and cord pH was 6.73 (acidotic). Apgars of 1, 3, and 3 were assigned a one, five and ten minutes respectively. Tano was pale, nonresponsive with a heart rate of 80 beats per minute. Cords were viewed, and a small amount of meconium was observed below the cords, with thick meconium in the oropharynx and nares. Tano responded to positive pressure ventilation (PPV), with increased heart rate to 120 to 180 beats per minute, but continued without respiratory effort or tone. Resuscitation included stimulation, PPV via mask, intubation with PPV, suctioning, and Narcan without response. Tano was transferred to the neonatal intensive care unit (NICU) for further management and at 3:10 a.m., June 13, 1995, he was transferred to All Children's Hospital. At All Children's Hospital, neurological evaluation revealed evidence of severe hypoxic and anoxic insult, metabolic screening demonstrated results compatible with metabolic acidosis, and sequential daily EEG's showed no spontaneous activity. Consequently, with family consent, artificial support was withdrawn and Tano expired at 11:25 a.m., June 16, 1995. Autopsy findings disclosed: . . . the presence of massive meconium aspiration that led to acute perinatal hypoxia, hypoxic-ischemic encephalopathy including white matter infarcts (periventricular leukomalacia) and thrombotic episodes observed in the adrenal glands, diaphragm, and lungs. No source of embolism is present. The possibility of an acute chorioamnionitis is not ruled out, as a proximate cause of perinatal difficulties; the placenta was not available at the time of autopsy. The death certificate described the cause of death as respiratory failure, due to apnea, as a consequence of hypoxic ischemic encephalopathy.
Findings Of Fact Petitioner attended a two year training program for physician's assistants at the State University of New York in Stonybrook. In the course of this program, petitioner spent ten weeks in an obstetrics rotation. During this ten week period, she delivered at least fifteen babies. She also attended mothers post partum. After moving to Florida, petitioner applied to respondent for a license as a lay midwife. Although she has approached more than ten obstetricians practicing in Florida, she found none willing to supervise her work as a midwife. In support of her second application for license as a lay midwife, petitioner attached a letter signed by Elspeth Reagan, M.D., and another, reciting that petitioner "performed approximately 15-20 normal, spontaneous deliveries under physician supervision and assisted with numerous others." Dr. Reagan's signature had been acknowledged before a notary public. Dr. Reagan is licensed as a physician in New York but is not licensed in Florida. Petitioner did not furnish respondent a list of the names, home addresses or delivery dates of any of the deliveries she performed. On December 4, 1978, respondent denied petitioner's second application on the grounds that it did "not conform to the requirements of . . . Chapter 10D-36.21(2) . . . . [or of] Chapter 10D-36.22(1)(a)2.
The Issue The issue is whether, in his treatment of patient H.M., Dr. Sewell failed to practice medicine with the level of care, skill and treatment which is recognized by reasonably prudent, similar physicians as acceptable under similar conditions and circumstances.
Findings Of Fact Jesse Q. Sewell, III, M.D., is a licensed physician in the State of Florida, holding license ME0028694. He has been licensed for eleven years. On or about February 11, 1986, Dr. Sewell was the treating physician for H.M. When H.M. visited his office, Respondent performed a pelvic examination and concluded that the patient was not pregnant, and prescribed a legend drug for birth control, Ortho- Novum. No test was done to determine if H.M. was pregnant because Dr. Sewell regarded those tests as an unnecessary expense to the patient. Dr. Sewell did not instruct the patient to wait until her next menstrual period to begin to take the birth control pills. Rather, he told H.M. to discontinue the pills if she did not have a period by the time she finished the first packet of pills. At the time of the examination, the patient was already six to eight weeks pregnant. By failing to perform a urine or blood pregnancy test on February 11, 1986, the care rendered by Dr. Sewell fell below that level of care, skill and treatment recognized as appropriate by reasonably prudent physicians. Under proper care, a urine or blood pregnancy test would have been ordered and Dr. Sewell would have instructed the patient not to use the birth control pills until she had had a period. It is generally recognized that birth control pills should not be prescribed for anyone who is pregnant or suspected of being pregnant. Dr. Sewell relies on six articles from medical journals to demonstrate that there is no discernible risk to a woman or fetus when taking birth control pills prior to, during or after conception. These articles include: Smithells, R.W. (1981) "Oral Contraceptives and Birth Defects," 23 Journal of Developmental Medical Childhood Neurology at 369; Rothman, K.J., and Louik, C. (1978), "Oral Contraceptives and Birth Defects," 299 The New England Journal of Medicine, at 522; Harlap, S. and Eldor, J. (1980), "Births Following Oral Contraceptive Failures," 55 Journal of Obstetrics and Gynecology at 447; Savolainen, E., Saksela, E. and Saxen, L. (1981) "Teratogenic Hazards of Oral Contraceptives Analyzed in a National Malformation Register," 140 American Journal of Obstetrics and Gynecology at 521; Cuckle, H.S. and Wald, N.J. (1982), "Evidence against Oral Contraceptives as a Cause of Neural-Tube Defects," 89 British Journal of Obstetrics and Gynecology, at 547; Harlap, S., Shiono, P.H., and Ramcharan, S. (1985), "Congenital Abnormalities in the Offspring of Women Who Used Oral and Other Contraceptives Around the Time of Conception," 30 International Journal of Fertility at 39. Dr. Sewell's contention that the current medical literature indicates no statistically significant risk to a woman taking birth control pills prior to, during or after conception, is accepted. The deposition testimony of Dr. Edward J. Zelnick was entered by the Board of Medicine. Dr. Zelnick indicated that the failure to perform a blood or urine pregnancy test and starting the patient on birth control pills without testing to determine whether or not the patient was pregnant was imprudent practice, and fell below community standards. He went on to testify that Dr. Sewell's action did not constitute malpractice because it resulted in no injury. In determining whether or not the care rendered failed to meet community standards, it is not relevant that the patient was not harmed. A patient may be fortunate enough to suffer no ill effects even though the care provided was substandard. The issue is quality of the care, not the severity of any injury which may or may not result from inadequate care. Whether the patient suffered an injury, and if so, whether that injury was severe is an appropriate consideration in assessing any penalty for failure to practice medicine with that level of care and skill recognized as appropriate by similar physicians. The testimony of Dr. Zelnick that a pelvic examination was insufficient, that urine or blood pregnancy test should have been performed, and the patient should have been informed not to use the birth control pills until after a period, is persuasive. Even if no injury was caused, it is obviously useless for a physician to prescribe oral contraceptives for a patient who, already being pregnant, requires no protection against conception. Accordingly, a physician ought to determine whether the patient is pregnant before prescribing oral contraceptives.
Recommendation It is RECOMMENDED that Dr. Sewell be found to have violated Section 458.331(1)(t), Florida Statutes, that he be fined $250, placed on probation for three months, and required to complete three hours of continuing medical education in the prescription of legend drugs, including birth control drugs. DONE AND ORDERED this 20th day of October, 1987, in Tallahassee, Leon County, Florida. WILLIAM R. DORSEY Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of October, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NO. 87-2567 The following are my rulings on the proposed findings of fact submitted by the parties pursuant to Section 120.59(2), Florida Statutes (1985). Rulings on Petitioner's Proposed Findings: Adopted in finding of fact 1. Adopted in finding of fact 2. Adopted in finding of fact 3. Adopted in findings of fact 5 and 7. Adopted in findings of fact 5 and 7. The gist of this finding is adopted in finding of fact 4 by stating the period of pregnancy as of the time of Dr. Sewell's examination and prescription of Ortho-Novum for the patient. Rulings on Respondent's Proposed Findings: The argument contained in Dr. Sewell's letter of September 28, 1987 is dealt with in finding of fact 6, adopting Dr. Sewell's argument that there is no statistically significant risk to a woman or her fetus in taking birth control pills prior to, during or after conception. Nonetheless, his actions constitute malpractice for the reasons stated in findings of fact 7 through 10. See also the Conclusions of Law. COPIES FURNISHED: Peter Fleitman, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Jesse Quimby Sewell, 111, M.D. 2855 Overseas Highway Marathon, Florida 33050 Ms. Dorothy Faircloth Executive Director Board of Medicine 130 North Monroe Street Tallahassee, Florida 32399-0750 Tom Gallagher, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
