The Issue The issue presented is whether Respondent is guilty of the allegations set forth in the Administrative Complaint, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the State of Florida, having been issued license number ME 0020248. Respondent is a board- certified pathologist who completed a residency in obstetrics and gynecology in Venezuela and practiced in the field of obstetrics and gynecology in South America for almost five years before coming to the United States. On April 20, 1991, patient J. B., a 27-year-old female, came to A Woman's Care, where Respondent was then employed, for the purpose of terminating her pregnancy. She indicated on a patient history form that the date of her last menstrual period was January 30, 199l. According to the medical records from A Woman's Care, she did not express any uncertainty or equivocation with respect to that date. One method of determining gestational age is based on calculating from the last menstrual period, assuming that the patient's history is reasonably reliable. With a history of a last menstrual period on January 30, 1991, the gestational age of the fetus on April 20, 1991, based upon a calculation by dates, was seven weeks. After obtaining a history from the patient with respect to the date of the last menstrual period, the physician needs to perform a bi-manual examination of the patient in order to assess the size of the uterus and to confirm the history given by the patient. Although the bi-manual examination is a reasonably reliable method of assessing the stage of pregnancy, it is a subjective examination and can sometimes be difficult. There is an acknowledged inaccuracy with respect to that clinical evaluation. The most accurate method of determining the gestational age of a fetus is through ultrasound examination. An ultrasound is performed when there is uncertainty as to the gestational age, such as when the patient does not know the date of her last menstrual period or when there is inconsistency between the patient's disclosed date and the physician's bi-manual examination. There is a general correlation between the size of the uterus in centimeters on bi-manual examination and gestational age in weeks. It is important to determine the gestational age of the fetus before performing a termination of pregnancy because the gestational age is the determining factor in deciding the size of the instruments to be used in the procedure and the amount of tissue to be removed. Respondent performed a bi-manual examination of the patient and recorded that his examination revealed a uterus consistent with an approximately seven-week gestation. Because the gestational age by dates and the results of the bi-manual examination both indicated a seven-week pregnancy and were consistent, Respondent did not order an ultrasound examination for the purpose of determining gestational age. On April 20, 1991, Respondent performed a termination of pregnancy on patient J. B. after the patient was informed of the possible risks of the procedure and after the patient signed a Patient Informed Consent Form. That Form detailed the possible risks, including infection and incomplete termination. Based upon the patient's history and the bi-manual examination and his conclusion that the patient was approximately seven-weeks pregnant, Respondent used an 8 mm Vacurette to terminate patient J. B.'s pregnancy. An 8 mm Vacurette is an appropriately-sized device to terminate a seven-week pregnancy. After completing the procedure, Respondent submitted the tissue obtained to a pathologist who determined that three grams of tissue had been submitted, consisting of products of conception and chorionic villi. The pathology report revealed what would reasonably be expected as a result of the termination of a seven-week pregnancy. After the procedure, the patient was given written instructions for her care and was discharged from A Woman's Care at 10:35 a.m. On April 21, 1991, at approximately 6:30 a.m., the patient's grandmother telephoned A Woman's Care to advise that the patient was complaining of dizziness and pain. The patient was advised to take Tylenol and call back if she continued to feel sick. At approximately 7:30 a.m., the patient's grandmother called again to advise that the patient was going to go to the hospital. On April 21, 1991, at 1:25 p.m., patient J. B. arrived at the Emergency Room at North Shore Medical Center with a temperature of 104.3 degrees, an elevated white blood cell count, chills, lower abdominal pain, and spotting. The patient was seen during her North Shore admission by Dr. Ramon Hechavarria, a physician certified in obstetrics and gynecology, and by Dr. Tomas Lopez, a general surgeon. Dr. Lopez noted in his consultation report that a pelvic bi-manual examination that he performed on April 21 showed an enlarged uterus corresponding to approximately 11-12 weeks' gestation. An ultrasound examination done on April 21 revealed a uterus measuring 11.0 x 7.8 x 7.8 centimeters and a viable intra- uterine pregnancy which was estimated by the radiologist to be 13-14 weeks' gestational age. On April 22, the patient underwent termination of her pregnancy by Dr. Hechavarria who noted in his operative report that both the pelvic ultrasound and a bi-manual examination revealed an intra-uterine pregnancy of about 11 weeks with a live fetus. An ultrasound performed intra-operatively confirmed that all fetal tissue had been removed and that there were no perforations. Infection and an incomplete termination are two of the recognized complications resulting from terminations of pregnancy. The fact that a patient suffers an infection or an incomplete termination does not, per se, indicate any negligence on the part of the physician. Respondent did not fall below the recognized standard of care by failing to perform an ultrasound on patient J. B. His examination revealed a gestational age consistent with the date identified by the patient as the date of her last menstrual period. Accordingly, there was no need to perform an ultrasound. Respondent did not fall below the recognized standard of care by misjudging the gestational age of the fetus. It is not uncommon for a physician to misjudge the length of gestation by several weeks. For example, Drs. Lopez and Hechavarria concluded the fetus had a gestational age of 11 weeks; yet, the ultrasound reported 13-14 weeks. Respondent did not fall below the recognized standard of care by using the wrong size of equipment to perform the termination of pregnancy. He used the proper equipment consistent with his judgment as to the length of gestation.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED THAT a Final Order be entered finding Respondent not guilty of the allegations and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 25th day of July, 1997, at Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 25th day of July, 1997. COPIES FURNISHED: Hugh R. Brown, Esquire Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jonathon P. Lynn, Esquire Stephens, Lynn, Klein & McNicholas, P.A. Two Datran Center, Penthouse II 9130 South Dadeland Boulevard Miami, Florida 33156 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309
Findings Of Fact Mrs. Martha Truitt owned a five pound Chihuahua female named Hale's Dixie Dynamite which she purchased for $624.00 in 1977. At that time Dixie was one year old. She was later bred in August, 1978. Mrs. Truitt has been a Chihuahua breeder for seven to eight years. She has seen approximately fifteen to twenty litters of dogs delivered and considers herself an expert breeder. At the hearing, Mrs. Truitt, as a breeder, displayed some ill feeling toward doctors of veterinary medicine (vets). It was also apparent from the testimony of the expert witnesses, that the ill feelings were somewhat reciprocated by the vets. There is apparent professional jealousy over who, the breeder or the vet, knows the most about the proper care of dogs. On October 2, 1978, Mrs. Truitt took Dixie to Dr. Chatham for an ear mite examination. At the conclusion of the examination, Mrs. Truitt asked Dr. Chatham if he could be available at the end of the month because Dixie was pregnant and was expected to deliver then. Dr. Chatham said he would be available if necessary. There was no firm understanding reached between the parties on exactly what "being available" meant to either person. Mrs. Truitt did not hire Dr. Chatham as an obstetrician for Dixie and he was not requested to give her any prenatal care. There was no further contact between parties until October 24, 1978. Dixie received no prenatal care from any vet. Mrs. Truitt relied on her experience as a breeder to give Dixie the care she thought appropriate. Dr. Chatham has practiced veterinary medicine in Auburndale, Florida, since 1977. In his practice he has performed approximately 40 Caesarian sections in dogs and has seen several hundred dystocia (abnormal delivery) cases. In the afternoon of October 24, 1978, Dixie went into mild labor. Mrs. Truitt called Dr. Chatham in the late afternoon or early evening to tell him of Dixie's progress. Again at midnight or 1:00 A.M., on October 25, Mrs. Truitt called Dr. Chatham. She had observed Dixie begin strong contractions and the aminon had broken discharging its "water." She explained to Dr. Chatham that Dixie was now in hard labor and asked for advice. He said to watch the dog and call him back in one hour if any problems developed. Around 3:00 A.M., Mrs. Truitt again called Dr. Chatham. She was advised to examine Dixie to determine if the first puppy had presented itself in the birth canal. During this conversation Mrs. Truitt requested Dr. Chatham to immediately examine Dixie. He did not believe that was necessary as he knew from past experience that a dog could safely remain in labor for more than twelve (12) hours. He did say that if the first puppy had not been born by 7:30 A.M., in the morning to bring Dixie to his office and he would examine her to determine if a Caesarian section would be necessary. At 7:30 A.M., Mrs. Truitt arrived at Dr. Chatham's Office with Dixie. He was not there upon her arrival. She contacted him through his answering service and by 9:30 A.M., he had arrived and performed the Caesarian section on Dixie and delivered three (3) live puppies. By noon of that day Mrs. Truitt took Dixie home. Unfortunately the little dog died on the next day, October 26, 1978. When a Caesarian section should be performed on a laboring dog depends upon a variety of factors. If all other factors are equal, a small dog does not have the capability to labor safely as long as a large dog. If the dog has a discolored vaginal discharge then an immediate Caesarian is indicated. Caesarian sections are a moderately dangerous operation because the mother dog is already under stress from the labor and from giving life support to her puppies. For that reason, it is not advisable without considerable necessity to add the additional trauma of a Caesarian to her already burdened state. Additionally, vets are reluctant to perform a Caesarian section at night if, like Dr. Chatham, they do not have staff available then to assist them in the operation. Because of the foregoing factors it is good veterinary practice to allow a mother dog to labor at least twelve (12) hours before considering a Caesarian section. Only 25 to 30 percent of dystocia cases eventually do require a Caesarian. The balance of the cases work themselves out without any necessity of surgery.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That the Second Amended Administrative Complaint be dismissed. DONE and ENTERED this 8th day of September, 1980, in Tallahassee, Florida. MICHAEL PEARCE DODSON Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 8th day of September, 1980. COPIES FURNISHED: Bert J. Harris, III, Esquire BOYD HARRIS & SMITH P.A. Suite 210, Barnett Bank Building Post Office Box 10369 Tallahassee, Florida 32302 William F. Casler, Sr., Esquire 6795 Gulf Boulevard St. Petersburg Beach, Florida 33706 Ken Oertel, Esquire General Counsel Department of Professional Regulation 2009 Apalachee Parkway Tallahassee, Florida 32301
The Issue Whether Respondent, Doctor's Office for Women, Inc., d/b/a Today's Women Medical Center (Respondent), failed to maintain medical records as alleged in the Administrative Complaint filed with DOAH on March 28, 2012.
Findings Of Fact At all times relevant to this proceeding, Respondent has been licensed as an abortion clinic authorized to perform first and second trimester abortions. The facility at issue in this proceeding is located in Miami-Dade County, Florida. Respondent is required to comply with the following provisions of Florida Administrative Code Rule 59A-9.031: A permanent individual clinical record shall be kept on each clinic patient. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval. Clinical records involving second trimester abortion procedures shall be kept confidential and secure. Operative reports signed by the physician performing the second trimester abortion shall be recorded in the clinical record immediately following the procedure or that an operative progress note is entered in the clinical record to provide pertinent information. Clinical records shall be kept on file for a minimum of five years from the date of the last entry. At the times relevant to this proceeding, Respondent used a consent form which, preceding the line for the patient to date and sign the form, states as follows: I, , voluntarily authorize Doctor's Office for Women, [Dr. Rosenthal], who is an independent provider and will have complete control over this procedure, follow up and any and all treatments and whomoever he may designate as his assistants, to perform upon me an elective abortion. I fully understand that the purpose of the procedure is to terminate my pregnancy, and I affirm this is to be my personal choice in the light of the alternative of continuing the pregnancy to full term. I further request and authorize him to do whatever he deems advisable if any unforeseen conditions arise in the course of the abortion that call, in his judgment, for procedures in addition to or different from those contemplated. I will fully and completely disclose my medical history, including allergies, blood conditions, prior medications or drugs taken, and reactions I had to anesthesia, medicines of [sic] drugs, I consume to my physician relying on my disclosure to be complete. I consent to the administration of anesthesia as may be deemed necessary or advisable by my physician. I understand that local anesthesia do not eliminate all pain completely and IV sedation anesthesia (Versed, Valium, Demerol) will not put me to sleep and no guarantee to the contrary have been made to me. The nature and purpose of an abortion, the procedures, the risks involved, the emotional distress, and the possibility of complications have been fully explained to me. I realize there are inherent risks of minor and major complications which may occur in this and all surgical procedures without the fault of the physician. No guarantee has been made to me. The complications include, but are not limited to: allergic reaction to the sedative or anesthesia; infection; excessive bleeding; the need for a second D&C to complete the abortion; perforation of the uterus; laceration of the cervix; hysterectomy - surgically removing the pregnancy through the abdomen; removal of the uterus as treatment of a complication (hysterectomy), also, one study indicates the possibility of breast cancer due to abortions even though these studies are not conclusive, we still recommend annual breast examinations, etc. [sic]. I release the doctors and Doctor's Office for Women and any corporation which operates this facility from any liability resulting from the above mentioned [sic] or any other complications. I further realize that I may need to be hospitalized at my own expense for treatment of such complications. I realize that such conditions can be caused by my own condition or conduct. I will accept hospitalization, if required by the doctors for any complications arising from this procedure. I understand that my complication requiring hospitalization, as a result of the termination will not be covered financially by the Doctor's Office for Women, or corporation which may operate this facility or the doctors. I understand that any questions I have will be answered before leaving the facility. If I have any questions or complications after leaving, I agree to call the Doctor's Office at this number: [xxx- xxx-xxxx]. I understand that I must return to the office for a two-week post-termination evaluation (free). I also acknowledge that if I do not return for this evaluation, I have not completed my medical care and release the Doctor's Office for Women and physicians from any liability resulting from my termination. The undersigned hereby expressly waives and releases for themselves, heirs or representatives any claims or demand which they may have of any nature, kind or description against [Dr. Rosenthal] and/or his/her assistant/s and Doctor's Office for Women, and any corporation which operates this facility and the undersigned do [sic] specifically assume any and all responsibility for the operation, acknowledging that the same is done at their [sic] request for their benefits [sic]. I certify that (if married) I have notified my husband of my intention to obtain a termination of pregnancy and I have given him the opportunity to consult with me concerning this decision. I CERTIFY THAT I HAVE READ AND FULLY UNDERSTAND THE ABOVE CONSENT TO AN ABORTION THAT THE EXPLANTAIONS THEREIN REFERRED TO WERE MADE [sic]. I GIVE THIS PERMISSION VOLUNTARILY AND OF MY OWN FREE WILL, I FURTHER REPRESENT AND WARRANT THAT I HAVE FULL LEGAL AUTHORITY TO GIVE THIS PERMISSION. On July 18, 2011, the Patient executed the foregoing consent form, and Dr. Rosenthal performed an abortion on the Patient. On September 20, 2011, Ms. Render inspected the Patient's medical records as maintained by Respondent as part of a survey of the facility. Respondent's records for the Patient reflect the events of July 18, 2011. The Patient's records reflected that the Patient was seen at an emergency room on a date between July 18 and September 13, 2011. The Patient's records did not reflect the date of that visit to the emergency room. The Patient's records reflect that the Patient had gone to the emergency room due to excessive bleeding for a sustained period of time following the abortion on July 18, 2011. The Patient's records reflect that all findings at the emergency room were "WNL" (within normal limits), but the records have no further information as to the emergency room visit. On September 13, 2011, the Patient returned to Respondent's facility, at which time Dr. Rosenthal performed on the Patient a procedure generally referred to as a D&C (dilation and curettage). The Patient did not sign a separate consent form for the second procedure. Ms. Randolph's testimony, and the consent form itself, established that the consent form authorized emergency follow-up care for the abortion, but it was insufficient to authorize the D&C some eight weeks after the abortion. Petitioner established that Respondent should have obtained written consent for the second procedure and should have maintained that consent as part of the Patient's records.1/
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of failing to maintain a consent form for the second procedure, but dismissing all other charges against A Doctor's Office for Women, Incorporated, d/b/a Today's Women Medical Center. It is further recommended that the final order impose an administrative fine in the amount of $1,000.00 against A Doctor's Office for Women, Incorporated, d/b/a Today's Women Medical Center. DONE AND ENTERED this 31st day of July, 2012, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON 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 31st day of July, 2012.
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 are whether Respondent is guilty of violations of Section 458.331(1)(k), (m), and (t) in the practice of medicine and, if so, what penalty the Board of Medicine should impose.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0033129. His license was originally issued on August 2, 1978, and remains current. There is no prior discipline against Respondent. Respondent has been certified for over 15 years by the American Board of Obstetrics and Gynecology. His practice has been devoted to obstetrics and gynecology. In 1990, Respondent was a member of a large group practicing obstetrics and gynecology in Cape Coral. Respondent was performing about 100 breast examinations a week. On the evening of April 10, 1990, D.W., who was 30 years old at the time, discovered a mass that felt like a marble in her right breast during a breast self-examination. She was upset and cried most of the night, fearful that she had breast cancer. Early the next morning, she made an appointment with Respondent's group for a breast examination later that day. A regular patient of another member of Respondent's group, who was unavailable on April 11, D. W. had last been seen by a member of Respondent's group on February 6, 1990, when her regular physician gave her an annual examination. Her breast examination at the time was normal. During the visit, the physician or nurse reviewed breast self-examination techniques with her. The physician started D. W. on birth control pills and directed her to return for a follow-up visit in two months. The April 11 office visit was devoted exclusively to addressing D. W.'s complaint of a lump in her breast. Respondent examined D. W.'s breasts with D. W. lying down and then sitting up. He felt nothing. While sitting up, D.W. guided Respondent's hand to the mass in the right breast. Still feeling nothing, Respondent remarked that the breast was somewhat fibrous. Respondent explained to D. W. that fibrocystic disease is something that women sometimes get in their breasts and it is nothing to worry about. In fact, at least 80 percent of all women in their 30s undergo fibrocystic changes in the breast. Respondent did not reach a specific diagnosis as a result of the April 11 office visit. The handwritten entries in Respondent's medical records--the complaint and blood pressure appearing to have been written by a nurse--read in their entirety: 4-11-90 Pt. c/o lump in R breast. BP--100/60 no mass found somewhat fibrous [Respondent's initials] Respondent did not advise D. W. to return to the office for a follow-up visit at a prescribed interval or if she detected the same mass or any changes in the mass. D. W. next visited Respondent's group on April 11, 1991, for her annual visit. She was seen by another physician in the group. D. W. told the physician of the lump in her breast and said that it was getting larger. The physician conducted a breast examination and felt a mass about two centimeters in diameter. Concerned about the mass, the physician scheduled an aspiration for diagnostic purposes. The results of the procedure disclosed severely atypical cells that were suspicious for carcinoma. The physician referred her to a surgeon, who first saw D.W. on May 2, 1991. The surgeon performed a breast biopsy on May 9. The biopsy revealed an infiltrating ductal carcinoma of the breast. Based on the biopsy findings, the surgeon conducted on May 17 a right modified radical mastectomy. The excised tumor measured 2.1 centimeters along its longest diameter. D. W. underwent chemotherapy and has had no recurrence of the cancer in the five years since the surgery. There are two sets of allegations concerning D.W.'s medical records. The first set of allegations is that Respondent fraudulently altered D. W.'s medical records. Someone in Respondent's office later typed the following addition to the records of D. W. immediately beneath the handwritten entry quoted above: D[.] came to the office today having felt a lump in her right breast. I could not feel anything, although her breast was somewhat fibrous. I told her to continue to check her breast and come back if she felt it again. [Respondent's initials/typist's initials-- {both typed}] Petitioner failed to prove that Respondent dictated or typed the note in the preceding paragraph or that he authorized the addition of this note to D.W.'s medical records. The intent in adding the note was fraudulent as to the third sentence, which is the only sentence in the note that is untrue. But Petitioner failed to prove that Respondent was in any way involved in the fraud. The second set of allegations concerning the medical records involves the adequacy of the records. Specifically, Petitioner alleges that Respondent failed to keep medical records justifying the course of treatment and violated the applicable standard of care by failing to keep adequate medical records. These allegations are best considered together with the remaining allegation, which is that Respondent violated the applicable standard of care by failing to recommend follow-up examinations and treatments for D. W.'s complaint of a lump in her breast. A violation of the applicable standard of care is the failure to practice medicine 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. The standard of care in this case pertains to the practice in early 1990. Petitioner nowhere alleges that Respondent violated the applicable standard of care by failing to detect the mass of which D.W. complained. Petitioner's expert witness, Dr. Harvey Gardy, conceded that such a failure would not necessarily violate the standard of care. Nor is it clear that the mass of which D.W. complained in April 1990 developed into the tumor removed from her breast a year later. The mass of which D. W. complained in April 1990 was in the three o'clock position, and the excised tumor was in the 12 o'clock position. Breast tumors do not change location, except to the extent that they grow, although patients conducting self- examinations may have difficulty locating the tumor with precision. Also, the excised tumor could have grown from an impalpable size in April 1990 to its size at the time of the mastectomy a year later. The second set of medical records allegations and the lone remaining standard of care allegation focus not on Respondent's alleged failure to detect and diagnose the mass of which D. W. complained, but on Respondent's alleged failure to respond adequately to D. W.'s complaint, even after he could not independently verify the mass. The applicable standard of care did not require Respondent to order further testing at the time to rule out a cancerous growth when he could not feel the mass. D. W. was not in a high-risk category for breast cancer based on her young age, three past pregnancies, and relevant family history. She displayed no physical signs of breast cancer. The physician conducting a breast examination is looking for a dominant or distinct mass--an isolated lump distinct from surrounding breast tissue. Respondent felt only fibrous changes. The applicable standard of care did not require that a physician order further diagnostic testing each time the physician detected a fibrous mass in a breast. Fibrous changes are not indicative of breast cancer. Petitioner has failed to prove that the applicable standard of care was any different when the patient claimed to have felt a distinct mass that the physician is unable to verify. It is more practical to direct a patient to return for a follow-up examination than to order potentially expensive tests. However, Petitioner failed to prove that the applicable standard of care required that a physician, failing to detect a mass in a patient not in a high-risk category for breast cancer, direct her to return to the office at a specified interval, such as two or three months later. Even less onerous than diagnostic testing or return office visits is the physician's direction that the patient return to the office if she feels the mass again or any changes in the mass. However, Petitioner failed to prove that the applicable standard of care required even this sensible precautionary direction from a physician. Testifying unpersuasively that the standard of care required the setting of a follow-up appointment, Dr. Gardy failed to testify at all whether the standard of care required Respondent to tell D. W. to return if she detected the mass again in a self-examination. One of Respondent's expert witnesses, Dr. Pierre Bouis, testified clearly on direct that the applicable standard of care did not require Respondent to direct D. W. to return if she felt the mass again (Tr. p. 125). On cross-examination, Dr. Bouis returned to the same issue and answered affirmatively the following, poorly worded question: Now, isn't it true that you also believe that it's an appropriate standard of care to tell a patient who presents under the same set of fact that she should keep checking herself and return if she feels it again or continue to feel it? Although there are many levels of care, there is a single applicable standard of care, which, if violated, justifies the imposition of discipline. By using "an," Petitioner's counsel suggested multiple standards of care and left open the possibility that the standard to which Dr. Bouis referred in his answer was aspirational, rather than mandatory. Respondent's other expert witness, Dr. J. Kell Williams, testified clearly that Respondent's failure to direct D. W. to return if she felt the lump again did not violate the applicable standard of care (Tr. pp. 43 and 52). Dr. Williams conceded that the better practice would have been to direct the patient to return (TR. pp. 43, 46, and 47), but he did not equate this practice with the applicable standard of care. In the absence of evidence establishing this sensible precaution as the applicable standard of care, Petitioner has failed to prove by clear and convincing evidence that the applicable standard of care required Respondent to advise D. W. that she should return to the office if she felt the mass again or any changes in the mass. The medical records are adequate for the limited purpose of the April 11 visit. They describe the findings and adequately outline Respondent's examination of D. W. They justify the course of treatment--which was effectively no treatment--for the reasons set forth in the preceding paragraphs. For the reasons set forth above, Petitioner has failed to prove by clear and convincing evidence the material allegations of the Administrative Complaint.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint against Respondent. ENTERED on May 31, 1996, in Tallahassee, Florida. ROBERT E. MEALE, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings on May 31, 1996. APPENDIX Rulings on Petitioner's Proposed Findings 1-3: adopted or adopted in substance, except she told him about the lump. Respondent never saw a lump. 4: adopted or adopted in substance, except that Respondent did not feel the marble-like mass that D. W. felt. Respondent felt only fibrocystic changes in the breast. 5-9 (second sentence): adopted or adopted in substance. 9 (remainder): rejected as irrelevant and recitation of testimony. 10-11 (second sentence): adopted or adopted in substance. 11 (remainder): rejected as irrelevant and recitation of testimony. 12-13 (first sentence): adopted or adopted in substance. 13 (remainder)-15: rejected as subordinate. 16 (first sentence): adopted or adopted in substance. 16 (second sentence)-17: rejected as recitation of evidence. 18: adopted or adopted in substance, as distinguished from the 2 cm tumor within the larger excised mass. 19: rejected as subordinate. 20: rejected as unsupported by the appropriate weight of the evidence. 21: rejected as irrelevant with respect to applicable standard of care. 22: rejected as unsupported by the appropriate weight of the evidence. The questions posed Dr. Bouis were ambiguous as to whether he was describing the better practice or the applicable standard of care. 23-24: rejected as irrelevant with respect to applicable standard of care. 25: rejected as subordinate and irrelevant. 26: rejected as subordinate. 27: rejected as unsupported by the appropriate weight of the evidence. 28: rejected as subordinate. 29-32: adopted or adopted in substance. 33: rejected as subordinate. 34: rejected as unsupported by the appropriate weight of the evidence. 35: rejected as subordinate. 36-38: rejected as subordinate and recitation of testimony. 39: rejected as unsupported by the appropriate weight of the evidence. 40: rejected as recitation of testimony. 41-43: rejected as unsupported by the appropriate weight of the evidence. 44-45: rejected as irrelevant. 46: adopted or adopted in substance. COPIES FURNISHED: Dr. Marm Harris, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-54034 Steven Rothenburg, Senior Attorney Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 Bruce D. Lamb Shear Newman 201 East Kennedy Boulevard, Suite 1000 Tampa, Florida 33602
The Issue The issue in this case is whether Respondent, Cesar Augusto Lara, M.D., should be disciplined on charges alleged in the Administrative Complaint filed by Petitioner, the Department of Health (DOH), in DOH Case No. 96-12965. Essentially, the charges are that Respondent practiced medicine below acceptable standards after receiving a questionable chest X-ray on a patient on November 17, 1994.
Findings Of Fact Respondent is a Florida licensed physician, having been issued license number ME 0060883. He has been licensed to practice medicine in the State of Florida since 1991. Respondent is board certified in family practice. He maintains a private office practice in Clearwater. He is well-respected and has never been disciplined by the Florida Board of Medicine. This case concerns Respondent's care and treatment of patient D.G. After leaving the care of Respondent, D.G. was diagnosed with lung cancer. The patient died of the disease in August 1995, before having given any sworn testimony or statement regarding Respondent's care and treatment. Respondent began providing medical care to D.G. for upper respiratory problems in January 1994. She had a history of smoking and told Respondent that she had just quit. Some time later, D.G. presented to Respondent with complaints of swelling in the left hand and an inability to move her thumb. Respondent attempted conservative treatment of D.G.’s left hand and thumb; but when her condition did not improve, Respondent referred her to an orthopedic surgeon, Dr. Michael Rothberg, on March 31, 1994. Following referral to Dr. Rothberg, Respondent continued to serve as D.G.’s primary care physician, taking care of other problems unrelated to her left hand and thumb. On November 3, 1994, Dr. Rothberg had D.G. return to Respondent to obtain surgical clearance for surgery on her hand to be performed under regional block anesthesia on November 29, 1994. Dr. Rothberg specifically requested that Respondent include the following laboratory (lab) studies as part of the surgical clearance: CBC and SMAC routine blood studies; urinalysis; and an EKG. Respondent saw the patient for surgical clearance on November 14, 1994. Respondent conducted a physical examination and ordered the laboratory studies requested by Dr. Rothberg. In addition, Respondent decided to get a chest X-ray as part of his surgical clearance. Based on his physical examination of the patient, Respondent found D.G. to be generally healthy without any respiratory symptoms or contraindications for surgery. Pending receipt of the lab results, Respondent felt that D.G. could undergo the planned surgery by Dr. Rothberg; he did not anticipate lab results that would contraindicate the planned surgery. Respondent dictated a report to that effect in the patient's presence in the examination room. The typed dictation was initialed by Respondent two days later, on November 16, 1994. Respondent testified that, at the conclusion of the office visit on November 14, 1994, he requested that D.G. return to his office in 4-to-6 weeks for follow-up. Petitioner questioned Respondent's sworn testimony on the ground that there was no documentation in the medical record supporting it. But it was Respondent's routine practice to have patients return to his office following surgery so that he could follow the recovery of his patients from the surgery. In addition, Respondent marked an "encounter form" to indicate his desire for D.G. to return to the office for follow-up in 4-to-6 weeks. An "encounter form" is a common communication tool between a physician and his office staff. It provides a means by which the patient is billed for the services provided. It also provides the staff with direction on scheduling patients for return or follow-up visits. The patient presents the encounter form to Respondent's office staff on the way out of the office. Necessary patient payments are made, and the next appointment is scheduled. The office then utilizes the form to secure third-party payments. Petitioner suggested that the encounter form in evidence as Respondent's Exhibit 2 was fabricated on the ground that Respondent did not produce it until a short time before final hearing. Respondent denied the suggestion, explaining that he did not look for it at first because he did not realize how important it was. Respondent's testimony is accepted, and the suggestion of fabrication is rejected. Should the patient refuse the appointment requested by Respondent on an encounter form, or wish to call back and schedule it later, Respondent's office staff routinely would make a notation on the form indicating that the appointment was not scheduled or that the patient would call to schedule. In this case, no such notations were made on the form. Based on routine office practice, the absence of any such notation would signify, in all probability, that D.G. was given a follow-up appointment in the requested time frame before she left Respondent's office, that the appointment was entered in Respondent's computer, and that D.G. was given a card indicating the date of her appointment. By the time of the hearing, there was no way to verify D.G.'s follow-up appointment using Respondent's office computer. Some time in 1998, Respondent switched his office computer system. The new system does not have appointment information going back to 1994, and the old system with old appointment information was not retained. Two days later, on November 16, 1994, Respondent received an imaging report of D.G.'s chest X-ray. The radiologist reported questionable slight prominence of left hilar region, inferiorly, on the posterior-anterior view. On lateral view, no definitive density could be discerned. The radiologist suggested that comparison with old films would be helpful; if old films were not available, he recommended CT examination. Respondent initialed the radiologist's report the next day, November 17, 1994. Respondent testified that it was his routine practice to initial such a report when he reviewed it. He testified that he decided not to withdraw surgical clearance based on the report. Petitioner questioned Respondent's testimony on the ground that there is no medical record documenting Respondent's decision, other than Respondent's dated initials on the imaging report. But Respondent's testimony in this regard is accepted, and Petitioner's suggestion that Respondent was not even aware of the content of the report is rejected. Respondent's medical record on D.G.'s medical record contains no other information until a pharmacist telephoned Respondent's office on January 18, 1995, to ask Respondent to authorize refilling a prescription for erythromycin. Respondent had his office relay to the pharmacist that Respondent would not authorize refilling the prescription unless Respondent saw the patient in his office. Respondent did not mention the missed appointment or questionable X-ray to the pharmacist, and D.G. never called for an appointment. On or about March 14, 1995, D.G. presented to another physician, Dr. Christopher Purcell, complaining of a five-day cough, pain in the left scapular region, and congestion and wheezing. There was no indication in Dr. Purcell's record that D.G. mentioned the questionable imaging report dated November 16, 1994. (Dr. Purcell did not testify.) On April 11, 1995, Dr. Purcell received D.G.'s medical records from Respondent's office, including the imaging report dated November 16, 1994. Dr. Purcell immediately ordered a repeat X-ray and referred D.G. for a consultation with a specialist on the same day. Not long after, D.G. was diagnosed with lung cancer. She died on August 10, 1995, from squamous cell lung cancer with metastasis to the thoracic spine. Notwithstanding the absence of any medical records between Respondent's dated initials on the imaging report on November 17, 1994, and January 18, 1995, Respondent testified to a clear recollection of discussing the report with D.G. He testified that he told her they would have to follow-up and resolve the questionable findings but that it could wait until follow-up after her planned surgery. Respondent testified that, for reasons unknown to him, D.G. canceled her follow-up appointment, never rescheduled, and never returned. There was no documentary evidence of D.G.'s canceled appointment, but the evidence was that no such evidence would exist except for cancellations or "no-shows" on the day of an appointment, in which case there would be a notation on a daily appointment sheet. For cancellations prior to the day of an appointment, the appointment would be erased from the calendar so the appointment time could be used for another patient. At the time, Respondent had no system in place for contacting patients who canceled an appointment without rescheduling. Now, after commencement of a lawsuit against him on the facts of this case, Respondent has instituted a "911" system of flagging patients whose medical condition requires the rescheduling of canceled or missed appointments. Petitioner contends that the evidence was clear and convincing that Respondent did not advise D.G. of the results of her chest X-ray or any plan for follow-up, notwithstanding Respondent's testimony that he did. Petitioner not only points to the suspicious absence of medical records (in contrast to Respondent's otherwise complete and accurate medical records) but also points out the patient's history of general good compliance with Respondent's orders and her failure to tell either her husband or Dr. Purcell about the questionable imaging report dated November 16, 1994. As for the absence of medical records, it was Respondent's routine practice upon receipt of a questionable X- ray or other lab report to ask for the patient's file and telephone the patient. Then, depending on the nature of the report and the patient involved, Respondent either would discuss the report and a plan for follow-up on the telephone or arrange for an appointment to discuss those matters in person in Respondent's office. If Respondent discussed the matter on the telephone, he normally would document the telephone call and the plan in the patient's medical record. However, it is possible that Respondent made the call to D.G. from outside the office without having her medical record available; it also is possible that he had to leave a message for D.G. and that her medical record was not readily available to him when she returned the call. Either scenario could have led to Respondent's failure to make a record of his telephone call to D.G. Respondent concedes that D.G. was a compliant patient who generally followed his orders and recommendations. She was interested and concerned about health issues affecting her and would not be inclined to ignore medical advice on them. But changes in Respondent's relationship with D.G.'s health care plan--PruCare--could explain why D.G. did not keep her follow-up appointment with Respondent. It was public knowledge that PruCare was terminating its contracts with several area physicians including Respondent, effective January 1, 1995. Respondent gave written notification of these events to his PruCare patients. PruCare also notified its insureds. Both the terminated physicians and PruCare placed advertisements in local newspapers asserting the merits of their positions in the dispute that arose from the termination. Newspaper articles also were published on the issue. It is highly probable that D.G. became aware of the contract termination in one way or another. As a result of the contract termination, PruCare would not cover visits to Respondent after January 1, 1995. Most PruCare patients changed primary care physicians to keep the financial benefit of their PruCare policies. It is possible that D.G.'s follow-up appointment was scheduled for just after the first of the year and that she called to cancel, anticipating following up with a new PruCare-approved primary care physician. Even if the follow-up appointment was scheduled for December 1994, it is quite conceivable that D.G. canceled it in the same anticipation. Normally, D.G. would discuss her health concerns with her husband. But her husband also testified that she did not discuss everything with him. Specifically, he had no knowledge that she was having a chest X-ray taken prior to her hand surgery. Nor did he know the specifics of any of the lab studies done for Respondent's clearance for surgery. It is more difficult to explain the patient's apparent failure to mention the questionable imaging report to Dr. Purcell on March 14, 1995 (based on the absence of any medical record documenting such a disclosure to him.) Assuming completeness of Dr. Purcell's medical records, it could well be that Respondent did not impress on D.G. the possible significance of the findings during his telephone conversation with her after review of the imaging report. He might not have seen the need to do so prior to the follow-up appointment he was anticipating. He also might not have wanted to so as not to unnecessarily complicate the impending hand surgery by making the patient overly anxious about the imaging report and what it could signify. Taking all of the evidence into consideration, it is found that Petitioner did not prove by clear and convincing evidence Respondent's alleged failure to advise D.G. of the results of her chest X-ray or any plan for follow-up. Besides Respondent, three physicians testified as experts in this case. All agree that the "level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances" (the "standard of care") required Respondent to notify the patient to discuss the report and a plan of follow-up, which could include: physical examination; review of older X- rays (to determine if there was a change between X-rays); a repeat X-ray; a CT study (for a clearer image than an X-ray); and referral to a specialist. The disagreements among the experts centered on the urgency of follow-up and the assumed facts. Respondent's two experts accepted the veracity of Respondent's testimony that Respondent discussed with the patient the imaging report and his plan for follow-up at the appointment scheduled for follow-up for the hand surgery. Petitioner's expert assumed the contrary. Petitioner's expert testified that it was incumbent on Respondent to follow-up within 24-48 hours. But it was not clear from his testimony if "follow-up" in this context meant anything other than notification to the patient and discussion of a plan for timely follow-up. If so, Petitioner's expert was at odds with the other experts, all of whom clearly testified to their opinions that the other means of follow-up could be accomplished within anywhere from two weeks to two months. (As for physical examination, Respondent already had examined the patient on November 14, 1994, and there were no symptoms. As for review of older X-rays, the only previous X-ray was from 1989, and Respondent testified to his opinion that simply reviewing an X-ray that old would not meet the "standard of care.") Respondent and his experts placed responsibility on the patient to follow her doctor's recommendations. They did not think the "standard of care" required Respondent to contact D.G. to remind her, much less require her, to reschedule her appointment. In all probability, D.G. would have rescheduled but for PruCare's cancellation of its contract with Respondent. Through a combination of circumstances for which they did not think Respondent should be held responsible, the patient did not reschedule her appointment and was "lost to follow-up" by Respondent. Based on the pertinent factual findings and the expert testimony, Petitioner did not prove by clear and convincing evidence that Respondent practiced medicine below the "standard of care." Petitioner also suggested that Respondent was at fault for not directing D.G. to a particular primary care physician for medical care after January 1, 1995. But Respondent and his staff testified that PruCare did not make Respondent aware of his patients' options for primary care after the contract termination. There was no evidence to dispute their testimony to that effect. Nor was there any evidence that the "standard of care" required Respondent to direct D.G. to a particular primary care physician for medical care after January 1, 1995. Finally, Petitioner suggested that Respondent had an obligation to follow-up on the missed appointment when the pharmacist telephoned on January 18, 1995. Petitioner's argument would have been stronger had the patient telephoned instead of the pharmacist. As it was, the evidence was not clear and convincing that a telephone call from a pharmacist should have triggered the realization that D.G. had missed her follow-up appointment. In addition, there was no evidence that the "standard of care" required Respondent to follow-up on the missed appointment at that point. Besides, it would have been reasonable for Respondent to assume at that point that D.G. probably would not return to him but would see a new primary care physician contracted to PruCare under the patient's health care plan. Clearly, early detection and treatment of cancer is important. But, while not particularly relevant to the question of whether Respondent practiced within the "standard of care," it is noted that all of the physicians testifying as experts agreed that the outcome probably would not have been different had D.G.'s cancer been diagnosed in November 1994. Unfortunately, lung cancer is difficult to detect; when detected, it usually is beyond cure, and death usually follows relatively soon thereafter.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Respondent not guilty. DONE AND ENTERED this 17th day of July, 2000, in Tallahassee, Leon County, Florida. J. LAWRENCE JOHNSTON 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 17th day of July, 2000. COPIES FURNISHED: Britt Thomas, Esquire Laudelina McDonald, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Jon M. Pellett, Esquire Freeman, Hunter & Maloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1703 William W. Large, General Counsel Department of Health 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
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 0017602. He graduated from St. Louis University School of Medicine in 1966. He taught obstetrics and gynecology at the Portsmouth Naval Hospital in 1970-1972. He was board-certified in obstetrics and gynecology in 1972 and retired from the active practice of medicine in 1996. Licensed in Missouri, Virginia, and Florida, Respondent has never been disciplined by Petitioner or any other licensing authority. During his active practice of obstetrics and gynecology, Respondent specialized in high-risk obstetrics, i.e., the treatment of patients whose lives and pregnancies are at risk during the course of their pregnancy. He treated patients with diabetes, with heart disease, with blood disease, and with abnormal pregnancies such as ectopic pregnancies. He is well respected in the medical community, including by others who practice high-risk obstetrics. He enjoys a reputation for being a caring, concerned, intelligent, and capable physician. On November 30, 1993, R. C. was a 35-year-old patient who had been seen previously by Respondent's associate but not by Respondent. She had a long history of infertility and had been treated with fertility drugs. She had had one ruptured ectopic pregnancy that resulted in the removal of her right ovary. She had three failed attempts at in vitro fertilization. She reported to Respondent that she felt pregnant. She had taken three home pregnancy tests, which were positive. Her HMO primary care physician, following laboratory confirmation of her pregnancy, had referred her to Respondent. She advised Respondent that her last menstrual period was October 16, 1993. Respondent conducted a physical examination and agreed that she was pregnant. Her breasts were tender, and her uterus may have been a little soft but it was not enlarged. The presence of a normal-sized uterus at six weeks gestation, while not unusual, is one possible indication that a woman might have an abnormal pregnancy or be in the process of having a miscarriage. It raised the suspicion that the nature of her pregnancy, intra-uterine versus abnormal, must be considered by Respondent. However, enlargement of the uterus during pregnancy is different for each patient. Significantly, R. C. did not have any bleeding. She had no abdominal pain, and no adnexal masses were palpated. Essentially, she was asymptomatic for an abnormal pregnancy. Because of her history, Respondent considered R. C. to be at a higher risk for an abnormal or ectopic pregnancy than that expected for a normal female from the general population. It is generally understood that the risk of a repeat ectopic pregnancy is between 10 and 15 percent. Respondent was aware that even with an ectopic pregnancy, the uterus undergoes many of the changes associated with an early normal intra-uterine pregnancy, including an increase in uterine size and softening of the cervix. These changes occur as a result of the hormones circulating through the body during the early stages of pregnancy. Concerned since R. C. was at risk although asymptomatic, Respondent decided that the prudent course would be to evaluate R. C.'s pregnancy to rule out an ectopic or other abnormal pregnancy. Consequently, he took steps different from those that would be taken during a normal routine pregnancy. Respondent obtained an immediate quantitative human chorionic gonadotropin (hCG) value that day. The quantitative hCG is a diagnostic test available to physicians to evaluate the progress of a pregnancy when there is concern as to its nature. It is not a test that is ordered when there is no concern as to the nature of the pregnancy. The test measures the secretions of the placenta. It confirmed R. C.'s pregnant state and was an indicator of the presence of a placenta somewhere in her body. The hCG value was reported as 7,371. By itself, the hCG value told Respondent little about R. C.'s pregnancy. It did, however, provide some comfort that R. C. might have an intra-uterine pregnancy, particularly given her lack of symptoms for an ectopic pregnancy. It is generally understood that less than 25 percent of ectopic pregnancies have hCG values greater than 6,000. With an hCG value greater than 7,000, R. C. was in the group more likely to have an intra-uterine pregnancy. Her lack of symptoms also indicated that she had an intra-uterine pregnancy. It is generally understood that bleeding is present in over 85 percent of cases where there is an ectopic pregnancy. Pain is present in over 90 percent of the cases where there is an ectopic pregnancy, and over half of such women have palpable adnexal masses or lumps. R. C. was not experiencing any of what are known as the classic triad of symptoms for an ectopic pregnancy. Respondent obtained the hCG to be used as a baseline. The quantitative hCG is best used serially, and a single value has no real meaning in evaluating the nature of a pregnancy. By repeating the test at certain intervals, a physician can observe where the pregnancy might be going from a hormonal point of view. The initial value is a starting point from which other tests can be used to determine if the pregnancy is likely normal or abnormal. In an early normal intra-uterine pregnancy, the hCG values generally double approximately every 48 hours. Then, the rise begins to plateau, and the doubling time lengthens. To determine the course of a pregnancy, repeat tests of the hCG at set intervals can be an aid in the diagnosis of ectopic pregnancies. The possibility of an ectopic or other pathologic pregnancy exists when the hCG value fails to rise in accordance with the expectations of a normal intra-uterine pregnancy or does not rise at all. Although R. C. was asymptomatic, given her history, Respondent determined that he should obtain a repeat hCG and an ultrasound examination to confirm the presence of an intra- uterine pregnancy. He scheduled the repeat hCG and the ultrasound to be performed 7 to 10 days from that visit, or December 9, 1993. Respondent's plan of treatment was reasonable under the circumstances. If R. C. had had any of the classic symptoms consistent with an ectopic pregnancy, the standard of care would have required an immediate ultrasound. However, R. C. did not have any symptoms. It is a matter of physician judgment as to when an ultrasound examination and repeat hCG should be obtained for an asymptomatic patient. When there is no urgent need for the tests, the standard of care does not define the time frame in which the tests should be performed. Respondent wanted to wait another 7 to 10 days to allow for better visualization of the fetus on the ultrasound and to avoid a misinterpretation of the result of the repeat hCG test. By waiting, Respondent would likely obtain more useful information from the ultrasound than if the ultrasound were performed that day or during the next few days. He wanted to combine the findings of the ultrasound with the results of the repeat hCG test. Reasonably-prudent, similarly-trained physicians support Respondent's conclusions. The possibility of a misinterpretation of the hCG results is lessened by the passage of a reasonable period of time between tests. Before she left the office on November 30, 1993, R. C. was asked to contact Respondent in two days to obtain the results of her initial hCG test and to follow-up on her condition. On December 2, 1993, R. C. contacted Respondent. During their telephone conversation, R. C. expressed concern that her pregnancy might be in the fallopian tube rather than the uterus. Respondent wanted to calm her fears. He inquired as to how she was doing, and she reported that she was doing fine, no bleeding or pain. Generally, an ultrasound is not performed until at least the fifteenth or sixteenth week. After speaking with R. C. on December 2, 1993, Respondent continued with his plan to obtain an ultrasound evaluation of R. C. in her 7th or 8th week of gestation. Her history indicated that Respondent should confirm the nature of her pregnancy, and Respondent took those steps necessary to monitor and confirm R. C.'s condition. At approximately 6:00 p.m. on December 6, 1993, R. C. contacted Respondent's office and spoke with his midwife. R. C. complained that she was having some cramping that began after she had eaten a very heavy meal. This is not an unusual complaint during a pregnancy. R. C. reported that the cramping was resolving, but she just wanted to touch base with someone. The midwife advised her to go to the emergency room if the cramping worsened during that evening or if she was concerned. The midwife also advised R. C. that if she felt better by morning but not completely better, she should come in to the office. If she felt fine, she should keep her scheduled appointment for the ultrasound. The advice given to R. C. by the midwife was appropriate and consistent with the standard of care. R. C. began to experience severe lower abdominal pain on the morning of December 7, 1993, and was taken to the emergency room of Bethesda Memorial Hospital. She did not have any vaginal bleeding. Respondent was present in the hospital when R. C. arrived at the emergency room, and he came immediately upon being called. An ultrasound was performed and confirmed that the uterus was empty except for a pseudo-gestational sac. A viable ectopic pregnancy was seen in the left adnexal area with an estimated gestational age of 6 weeks. Respondent assessed R. C. as having a leaking tubal pregnancy, and he had her taken to surgery immediately following the ultrasound. Respondent removed her left tube and ovary and provided blood transfusions due to free blood found in the abdomen. R. C. experienced a fever following the surgery, but she recovered and was discharged from the hospital. Respondent's plan and action in evaluating R. C. on her November 30, 1993, visit to his office were in accordance with the standard of care, and were reasonable and appropriate. The patient's telephone report of doing well on December 2, 1993, strengthened Respondent's judgment that there was no immediate need to obtain an ultrasound and repeat hCG and that he could wait until those tests were likely to be reliable.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 23rd day of February, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 23rd day of February, 2000. COPIES FURNISHED: Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750 Angela T. Hall, Agency Clerk Department of Health 2020 Capital Circle, Southeast Bin A02 Tallahassee, Florida 32399-1703 Britt Thomas, Esquire M. Rosena Hitson, Esquire Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Boulevard, Suite 1950 Tampa, Florida 33602
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 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
