Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, as well as certain stipulations of fact, the following relevant facts are found: The respondent Ali Azima was born in Iran and graduated from the Medical College at Tehran University, where he received his M.D. degree in 1961. He is Board-certified as an obstetrician-gynecologist. His experience includes the delivery of approximately 5,000 to 6,000 babies, the performance of approximately 3,500 termination of pregnancy procedures and the provision of about 1,000 intrauterine contraceptive devices to patients. At all times relevant to the charges in these proceedings, respondent was licensed by the Board of Medical Examiners in the State of Florida. Prior to the instant charges, respondent has had no Administrative Complaints filed against him. On February 18, 1981, Christine Sellers (now Kuchar) was admitted to the emergency room of Ft. Myers Community Hospital with severe abdominal pain. On that occasion, she learned that she was pregnant. On February 19, 1981, she went to the Southwest Florida Women's Clinic in Ft. Myers, operated by the respondent, for the purpose of terminating her pregnancy. Upon her arrival at the Clinic, she was asked to pay the requested fee and to complete two forms, a form entitled "Consent for Abortion, Anesthesia and Other Medical Services" and a form entitled "Patient Registration Record." The only medical information requested on these forms, in addition to height, weight and eye and hair color, regarded allergies to foods or medication, medication currently being taken and past operations or serious illnesses. For the latter question, N. Sellers answered "rheumatic fever." Respondent spoke to her for a few moments prior to the procedure, and performed a quick pelvic examination. He then performed the procedure for termination of the pregnancy, gave her some medication and instructed her to come back the following week for a follow-up examination. Respondent did not send any tissue specimen obtained from the procedure to a pathologist for examination nor did he administer Rhogam to the patient subsequent to the procedure. According to Ms. Sellers, neither respondent nor his staff performed any blood work or determined her vital signs before or after the abortion procedure, nor did anyone inquire of her as to her blood type or Rh factor. She knew that her Rh factor was negative, but did not volunteer this information to respondent because she did not realize that a negative Rh factor was important for purposes of a termination of pregnancy procedure. Respondent's medical records for Ms. Sellers do not indicate that blood was drawn from her or that her Rh factor was determined or known. While the record does indicate that a physical examination was "normal," no further information is provided. Ms. Sellers did not desire to return to respondent for her follow-up appointment. Instead, she made an appointment with Dr. Randall Cowdin for the same day she was supposed to see the respondent, February 26, 1981. On that occasion, Ms. Sellers was given a complete physical examination and her blood type was drawn. Upon learning that she had not been administered Rhogam following her termination procedure by respondent, Dr. Cowdin gave her an injection of Mini-Rhogam on February 26, 1981. Approximately one week later, on March 5, 1981, Ms. Sellers returned to Dr. Cowdin's office with complaints of severe right lower quadrant abdominal pain, with some nausea and vomiting. Dr. Cowdin determined that she was bleeding internally due to a ruptured right ectopic pregnancy, and immediately admitted her to the hospital. Emergency surgery was performed, resulting in the removal of the patient's right Fallopian tube and ovary. Ectopic or tubal pregnancies are difficult to diagnose. However, had a specimen of the tissue extracted from Ms. Sellers as a result of the procedure performed by respondent been carefully examined, it would have revealed that the products of conception had not been obtained from the patient's uterus as a result of that procedure. This finding would have at least raised the suspicion of an ectopic pregnancy. It would be extremely rare for a woman to have both an ectopic and a normal pregnancy at the same time. The chances for such an event are one out of 30,000. When performing abortions, four other physicians in the Ft. Myers area routinely send a tissue specimen to a pathology laboratory for examination. The purposes for this are to detect abnormalities, to determine if the patient was indeed pregnant and to determine the existence of an ectopic pregnancy. It is the respondent's practice to examine the tissue himself, having had some residency training in pathology and feeling competent to perform such an examination. If he has any doubts, he then sends a tissue specimen to a pathologist for further examination. It is extremely important to do a blood screening on a patient undergoing a termination of pregnancy proceeding. A determination of the hemoglobin level is significant in order to assess the risk of a procedure performed in a non-hospital setting and to prepare for the possibility of anemia after the procedure. The Rh factor needs to be determined so that Rhogam may be administered to the Rh negative patient. This injection combats antibodies and prevents sensitization or isoimmunization problems in the event of future pregnancies or future transfusions where the patient could again come into contact with Rh positive blood cells. The performance of a procedure to terminate a pregnancy without a determination of the patient's hemoglobin level and Rh factor constitutes medical treatment which falls below an acceptable standard of care. The patient medical records for Holli Schmidt indicate that she first went to the Southwest Florida Women' a Clinic, Inc. on December 1, 1977, and Dr. Azima performed a termination of pregnancy procedure. Her "Patient Information Sheet" lists her blood type and Rh to be "A+." On her follow-up exam, an IUD was inserted. This device was removed in December of 1980. On February 23, 1981, Holli Schmidt again went to respondent's Clinic. She completed a "Consent for Abortion, Anesthesia and Other Medical Services" form, told respondent that her last menstrual period had been about six weeks ago and that she was experiencing breast tenderness and nausea. A pregnancy test was performed on her, and the results were negative. Respondent performed a physical exam, noting on her record "Normal," and a pelvic exam, noting "Normal, uterus is not enlarged." Respondent then inserted a Copper 7 IUD, and instructed Mrs. Schmidt to return in one week. Ms. Schmidt did return on March 5, 1981, still complaining of breast soreness and slight nausea. Respondent performed another physical exam, noting "Normal," and a pelvic examination, noting "String is not visible, uterus sounded and IUD is in situ." The medical records do not indicate that she was given another pregnancy test on March 5, but respondent testified that she was and that such was written in the "pregnancy test book," a document not offered for admission into evidence. The records dated February 23 and March 5, 1981, do not indicate that blood work was done or that vital signs were taken. Mrs. Schmidt was instructed to return on March 14, 1981, but did not do so. On April 27, 1981, Holli Schmidt went to the offices of Yankopolos, Waterman and Cowdin, each of whom specializes in obstetrics and gynecology. The record dictated by Dr. Yankopolus indicates that Mrs. Schmidt told him that respondent had examined her the week before. She also told Dr. Yankopolus that she was having trouble with her IUD and was not feeling quite right, having symptoms of pregnancy. Dr. Yankopolus examined her, did not see the IUD string and determined that she was approximately 12 weeks pregnant. Fetal heart tones, which can be detected at 9 1/2 to 10 weeks of pregnancy, were heard. Dr. Yankopolus did no tests to determine if the IUD was still present, but did explain to Ms. Schmidt the dangers of possible miscarriage and infection from the presence of the IUD during pregnancy. It was noted that Ms. Schmidt "will consider all of the alternatives." On May 1, 1981, Ms. Schmidt presented herself to Dr. Waterman "for termination of pregnancy with a Copper 7 in place." After an examination, Dr. Waterman estimated that she was then "12-14 weeks size," and Dr. Cowdin concurred. This meant that conception occurred 10-12 weeks prior to the May 1st examination. Dr. Waterman performed the termination of pregnancy procedure. While his medical records for May 1, 1981, do not specifically state that he removed the IUD during the termination procedure, Dr. Waterman recalls that he did. A later notation on her medical records indicates that on March 30, 1982, Ms. Schmidt stated "she specifically remembers my removing it." Prior to the insertion of an intrauterine contraceptive device, the most important factor to determine is that the patient is not pregnant. An IUD can be the source of infection, thus endangering the mother and the baby during pregnancy. The safest and most appropriate time to insert an IUD is during the woman's normal menstrual period. While there are exceptions to this method, especially when the physician knows and trusts the patient, it falls below an acceptable level of care for a physician to insert an IUD when the patient has not had a menstrual period for six weeks, has symptoms of pregnancy and has been engaging in unprotected intercourse. Colleen Lundy, a registered nurse, went to respondent's office on March 5, 1981, for the purpose of undergoing a termination of pregnancy procedure. She completed the consent form and "Patient Registration Record" and spoke briefly with the respondent regarding some questions she had as to the procedure. Prior to the beginning of the procedure, no vital signs were taken and no blood work was performed. Respondent's medical record for Ms. Lundy simply indicates that the physical examination was "Normal." After respondent inserted the speculum, he requested his assistant to bring him Betadine, an antiseptic. The assistant informed him they were out of Betadine, and respondent replied, "use alcohol." Thereafter, patient Lundy felt a severe burning and was feeling very uncomfortable with the whole procedure. She informed respondent that she was not going to have the procedure, respondent removed the speculum and left the room, she dressed, received a refund of her fee and left. The burning sensation abated quickly. The following day, patient Lundy received a termination of pregnancy procedure at another clinic. Respondent admits that he told his assistant that alcohol could be used, but denies using any alcohol on patient Lundy. He further states that he did not perform the blood work because he did not perform the abortion. Darlene Baker first underwent a termination of pregnancy procedure performed by respondent in January of 1981. At that time, she completed a "Patient Registration Form," which inquired as to her height, weight, eye and hair color, allergies, prior operations or illnesses and current medications. She returned for another procedure on December 23, 1982, which was performed by the respondent. She received no counseling prior to the performance of this procedure, but did sign a consent form and a form explaining the procedure and risks for abortion. No further written information was obtained from her. While patient Baker does not recall that a physical examination or blood work was performed prior to the performance of the termination procedure, respondent's medical records for this patient indicate that a physical and pelvic examination were performed, that a blood pressure reading was taken and that the patient's "Rh is positive." Respondent did not send a tissue sample of the products of conception to a pathologist for further examination. Other physicians specializing in obstetrics and gynecology in the Ft. Myers area make it a routine practice to counsel abortion patients prior to the performance of the procedure. During the counseling session, the risks of the procedure involved are examined and other options for the management of an unwanted pregnancy are explored. Sufficient time is afforded between the counseling session and the performance of the termination procedure for patient reflection. The physical examination performed by these physicians includes the taking of vital signs, blood pressure, blood tests and a check of the abdomen, heart and lungs. Subsequent to the procedure, the products of conception are sent to a pathology laboratory for examination and the results are made a part of the patient's medical records.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that respondent be found guilty of violations of Section 453.331(1)(t), Florida Statutes, and that his license to practice medicine in Florida be suspended for a period of one (1) year. Respectfully submitted and entered this 24th day of July, 1984, in Tallahassee, Florida. DIANE D. TREMOR, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 24th day of July, 1984. COPIES FURNISHED: J. Riley Davis, Esquire 225 S. Adams St. Tallahassee, Florida 32301 Stephen Marc Slepin, Esquire 1114 E. Park Ave. Tallahassee, Florida 32301 Ellis S.Rubin, Esquire 265 NE 26 Terrace Miami, Florida 33137 Dorothy Faircloth, Executive Director Board of Medical Examiners 130 N. Monroe St. Tallahassee, Florida 32301 =================================================================
Findings Of Fact Petitioner Margaret Petty-Eifert, Miami, Florida, requested application forms for midwife licensure from Respondent Department of Health and Rehabilitative Services (HRS) by letter of March 22, 1982. By letter of April 19, 1982 Dolores M. Wennlund, Nursing Services Director of HRS, provided the necessary application forms. Her letter contained the following paragraph: There have been substantial changes in the Midwife Practice Act that will become effective July l, 1982. Therefore if you intend to request licensure under the present Midwifery Act, you will have to return your completed application promptly. By letter of June 8, 1982, Petitioner Petty-Eifert mailed copies of her application and required enclosures to Respondent and to Dr. Richard A. Morgan, Dade County Health Director. The application form provided for the County Medical Director to sign a statement as to whether or not the applicant demonstrates ability to complete standard birth certificates, and whether the applicant had provided evidence of behaviors and habits consistent with safe hygiene practice, use of equipment which is safe and sanitary, and compliance with "local ordinances, Florida statutes, and the Florida Administration (sic) Code." It also provided for a listing of not less than fifteen cases of labor attended by the applicant under the supervision of a duly licensed and registered physician within a one-year period, including the care of not less than fifteen mothers and newborn infants during the lying-in period. The application further required that the applicant provide statements of the attending physician in each case documenting the level of skill and competence exercised by the applicant during such births. By letter of July 6, 1982, Dr. Morgan forwarded his copy of Petitioner's application to Respondent with an unfavorable recommendation, together with a copy of his letter of the same date to Petitioner wherein he advised her that she had not qualified to practice as a lay midwife, and listed a number of instances where she had allegedly completed birth certificates "replete with errors and omissions," cited an instance where her behavior and habits had failed to be consistent with safe hygiene practice, and cited several instances of implied misconduct. The completed application with the Medical Director's unfavorable recommendation was received by Respondent on July 7, 1982. By letter of September 30, 1982, Gary J. Clarke, Assistant Staff Director, HRS, advised Petitioner Petty-Eifert that the Department had determined that her application should be denied, listing a variety of reasons based on her failure to meet the requirements of Chapter 485, Florida Statutes, and Chapter l0D-36, Florida Administrative Code. One of the cited reasons for denial was that two of the births listed in her application as evidence of her supervised experience were delivered in the hospital, and that therefore she had not attended fifteen cases of labor during the lying-in period as required by Section 485.031(4)(b), F.S., and Rule l0D-36.22(1)(a), F.A.C. Another reason cited for the denial was that she had filed birth certificates with misinformation in eight cases and therefore raised "serious doubts" about her ability to complete standard birth certificate forms, as required in Section 484.031(2), F.S., and Rule l0D-36.22(1)2(d), F.A.C. The letter further contained the following paragraph: Your application for lay midwifery licensure was submitted before June 30, 1982, and re- quested licensure under the old statute and applicable rules. Your application was judged against these standards and your licensure is withheld pursuant to the authority granted to the Department in 485.071(2) F.S. You have the right to request a hearing on this matter within 30 days of receipt of this letter pursuant to Chapter 120, F.S. Petitioner Petty-Eifert thereafter filed her Petition to determine the invalidity of Rules 10D-36.22(1)(a) and 10D-36.22(1)(d), Florida Administrative Code, pursuant to Section 120.56, Florida Statutes. (Testimony of Petitioner Petty-Eifert, Pettengill, Petitioners' Exhibits 3, 5, Respondent's Exhibits 4-7) By letter dated June 18, 1982, Terry L. DeMeo, Esquire, a Coral Gables attorney, transmitted the application of Janice Heller for licensure as a lay midwife to Respondent's Health Program Office, together with the required attachments. These included detailed statements by the supervising physician in sixteen cases of labor which took place over a fourteen and one-half month time span. The letter stated that although this was in accordance with statutory requirements, the HRS rule which stated that such cases must have occurred within a one-year period was considered invalid and unenforceable, citing a court decision. The letter further stated that the application had simultaneously been submitted to the Broward County Health Department, but in view of the history of that Department routinely denying midwifery applications, and the past bias on the part of Dr. George Trodella, it was requested that a neutral decision maker be designated to review the application. The letter and application was received by Respondent on June 23, 1982, without the required statement of the County Medical Director. By letter of July 21, 1982, Dr. George P. Trodella, Assistant County Health Director, Broward County Health Unit, advised Respondent that Petitioner Heller was not qualified for a variety of specified reasons. Thereafter, by letter of September 24, 1982, Petitioner Heller was advised by Respondent's Health Program Office Assistant Director Gary J. Clarke, that the Department had determined her application should be denied. A number of reasons were listed, including not having provided a record of having attended fifteen births within one year as required by Rule 10D-36.22, not having received a written recommendation for licensure by the County Medical Director as required by Rule 10D-36.22, and for "incompetently administered oxygen to a patient," thereby administering a substance for therapeutic purposes other than silver nitrate which was prohibited by Rule 10D-36.27, F.A.C. The letter further contained the same paragraph concerning the fact that Petitioner Heller's application was judged against the old statute and applicable rules since it had been filed prior to June 30, 1982. Petitioner Heller thereafter filed a Petition for administrative determination of the invalidity of Respondent's Rules 10D-36.22(1)(a) and (d), and 10D-36.27, F.A.C. (Testimony of Petitioner Heller, Clarke, Pettengill, DeMeo, Petitioners' Exhibit 4, Respondent's Exhibit 4, Respondent's Exhibit 3). Subsequent to filing their applications, Petitioners expended funds to travel to Tallahassee to take written and oral examinations and undergo interviews by Respondent. Petitioner Heller was accompanied by her counsel during the trip. (Testimony of Petitioners) During the 1982 legislative session, Timothy Monahan, who conducted legislative liaison for Respondent, was in the process of negotiations with various groups concerning proposed revisions to Chapter 485, Florida Statutes, concerning the licensing of midwives. At the request of a state legislator, he contacted Terry DeMeo who purportedly represented the Florida Midwives Associations. She had a "loose" relationship with the organization and undertook negotiations with Monahan on an unpaid basis on the verbal authority of a midwife, Linda Wilson, who DeMeo assumed was in charge of the group. She did not purport to be representing any specified individuals. Petitioner Petty- Eifert is not a member of the Florida Midwives Association, and Petitioner Heller is an associate non-voting member of the group. DeMeo was concerned with substantive aspects of the proposed legislation and also desired that any changes to the law be made effective July 1, 1982, rather than an earlier date as proposed by Respondent. As a result of their negotiations, Monahan was under the impression that DeMeo had entered into an "agreement" whereby HRS would consider under the existing statute and departmental rules any applications for midwife licensure filed prior to July 1, the effective date of the statutory revisions. DeMeo testified at the hearing that she had no recollection that this was a part of their conversations, and denied any knowledge of entering into an "agreement" concerning the matter. In any event, Monahan represented to his superiors that there was such a commitment to apply the existing law and rules, and this was followed in all cases involving applications filed prior to July 1, 1982. Twelve of the applicants were licensed subsequent to July 1, 1982, under the preexisting law and rules. Respondent views the filing of the instant challenges to its rules as a breach of the perceived "agreement." It is found that Petitioners were not parties to any agreement concerning the processing of their applications. (Testimony of Petitioners, DeMeo, Pettengill, Clarke, Respondent's Exhibit 1 (Deposition of Wennlund), 2 (Deposition of Stinson), 9- 10). Rule 10D-36.22, F.A.C., apparently implemented Section 485.031(4)(b), Florida Statutes. The statutory provision required as a qualification for licensure that an applicant must have attended under the supervision of a duly licensed and registered physician not less than 15 cases of labor and have had the care of at least 15 mothers and newborn infants during a lying-in period of at least ten days each. Rule l0D-36.22(1)(a) required that the applicant provide evidence of having attended the 15 cases "within a one (1) year period." In practice, Respondent normally required the one-year period to be the one-year period immediately prior to the filing of the application, although at least one exception had been made in this respect in a prior case. The intent of Respondent in adding the one-year requirement was to show that the applicant had demonstrated skills in the recent past, and to be compatible with the annual licensing period, and the one-year period of the vocational nurses program. (Testimony of Pettengill; Petitioner's Exhibit 2). Rule 10D-36.22(1)(d) apparently implements Section 485.031(2), Florida Statutes, which provides in part that an applicant must be able to fill out birth certificates legibly, which requirement may be waived for those persons with extended experience or in other exceptional circumstances. The rule requires that the application be accompanied by a written recommendation for licensure by the County Medical Director attesting to the applicant's ability to complete standard birth certificate forms, and to the fact that applicant's behavior and habits are consistent with safe hygiene practices, and the equipment and settings to be used in practice are safe and sanitary. Respondent's general basis for this requirement is that the County Medical Director serves as the registrar and maintains vital statistics in his county, and has overall responsibility for the public health program in his jurisdiction. Historically, midwives have been under the supervision of the county health office concerning inspection of facilities and procedures utilized by midwives. Respondent's stated purpose the is to have the County Medical Director obtain the necessary facts for presentation to the Respondent with either a favorable or unfavorable recommendation. Although the rule prescribes a "written recommendation for licensure," Respondent has on occasion in the past licensed an applicant even though the County Medical Director had submitted an unfavorable recommendation. Respondent's stated reason for requiring the County Medical Director's attestation as to the applicant's ability to complete standard birth certificate forms was to ensure the applicant's ability to provide accurate information. Since the County Medical Director handles the vital statistic function in his county, it was believed by Respondent that he would be in the best position to fattest to the applicant's ability in this regard. It is important that birth certificate forms be filled out accurately since the information provided is used for a variety of purposes, such as estimation of population, state planning, and the like. In addition, proper spelling of the name is important to the individual concerned, and an error in this regard requires the filing of an affidavit to change the birth certificate. (Testimony of Pettengill, Williams; Petitioner's Exhibit 1). Rule 10D-36.27, in apparent implementation of Section 485.081, Florida Statutes, prohibits the administration of "any drug, herb or other substance for therapeutic purposes except as provided in Section 10D-36.28 of this chapter." Rule 10D-36.28(2) requires a lay midwife to instill two drops of one percent fresh solution of silver nitrate into dyes of newborn infants within one hour after birth. The purpose of Rule 10D-36.27 was to ensure that midwives would not use "old home remedies," such as poultices, ointments, plugs, and sassafras which possibly could be dangerous to the infant. In the opinion of Respondent's Public Health Nursing Consultant, oxygen would be included in the term "other substances" as used in the rule. (Testimony of Pettengill).
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 Whether the statement that "The injection of Botox is not within the scope of practice for registered nurses and does not constitute the administration of medication," ("the Botox statement") constitutes an unadopted rule in violation of section 120.54(1), Florida Statutes (2014).1/
Findings Of Fact The following facts are found, as stipulated, admitted, or officially recognized (duplicates have been set forth only once): Stipulated Facts Ms. Shelley Kay Hill is a registered nurse in the state of Florida, license number RN 9317251. The Department of Health (DOH) is a state agency charged with regulating the practice of nursing pursuant to section 20.43, chapter 456, and chapter 464, Florida Statutes. Section 464.018(1)(h) provides that unprofessional conduct as defined by Board of Nursing rule constitutes grounds for disciplinary action. Florida Administrative Code Rule 64B9-8.005(13) provides that unprofessional conduct includes practicing beyond the scope of the licensee's license, educational preparation or nursing experience. Ms. Hill is licensed pursuant to chapter 464 and is a health care practitioner as defined in section 456.001(4). Botox is a medication. It is within the scope of practice for registered nurses in the state of Florida to administer medication. As of October 17, 2014, the Florida Board of Nursing website located at http://floridasnursing.gov/general-faqs states that a practical or registered nurse may not inject Botox as it is not within the scope of practice for practical or registered nurses. As of October 17, 2014, the Florida Board of Nursing website located at http://floridasnursing.gov/general-faqs states that Botox injection does not constitute the administration of medication. Petitioner's Requests for Admission served on Respondent DOH on October 17, 2014, in this case include an Exhibit "A" which is a printout of the "General FAQs" from the Board of Nursing's website on October 17, 2014. The scope of practice for a registered nurse licensed in the state of Florida includes the administration of medications. Injection is a form of administration of medication. Registered nurses are allowed to inject medications within the scope of nursing practice in the state of Florida. As of October 17, 2014, the Florida Board of Nursing website (located at http://floridasnursing.gov/general-faqs), under the section "General FAQs," states: Can a practical or registered nurse inject Botox? The injection of Botox is not within the scope of practice for practical or registered nurses and does not constitute the administration of medication. Petitioner's Amended Requests for Admission include Exhibit RFA-1, served on Respondent DOH on October 20, 2014, which is an accurate copy of a printout from the Florida Board of Nursing's website (http://floridasnursing.gov/general-faqs) under the Section "General FAQs," as it existed on October 17, 2014. Proposed Exhibit P-5, a copy of the proposed exhibit attached to Petitioner's Amended Requests for Admission as "RFA- 1" that was served on Respondent DOH on October 20, 2014, is authentic. Proposed Exhibit P-5, the exhibit attached to the Petitioner's Amended Requests for Admission as "RFA-1" that was served on Respondent DOH on October 20, 2014, is admissible. Injection is one of the methods of administration of a medication. There has been no Florida Law Weekly notice regarding rulemaking as it relates to the injection of Botox by nurses. The definition of "registered nurse," as stated in section 464.003(22), is as follows: "'Registered nurse' means any person licensed in this state to practice professional nursing." Botox is a drug. The Florida Department of Health and the Florida Board of Nursing have disciplined registered nurses for administering Botox by injection, as indicated in Final Order No. DOH 12-2134- S-MQA in Department of Health vs. Debra Ann Leckron, R.N., DOH Case No. 2012-01979, filed October 11, 2012. (Order entered Nov. 20, 2014). The Florida Department of Health and the Florida Board of Nursing have disciplined registered nurses for administering Botox by injection, as indicated in Final Order No. DOH 14-0617- S-MQA in Department of Health vs. Maritza Novas, R.N., DOH Case Nos. 2013-05848 and 2013-06561, filed April 18, 2014. (Order entered Nov. 20, 2014). The Board of Nursing's statements regarding the injection of Botox by nurses are statements of general applicability to nurses. Admissions There is no Florida Administrative Code rule that specifically prohibits the administration of Botox. The Florida Board of Nursing has made no declaratory statements regarding the administration of Botox by nurses. Officially Recognized Facts On October 24, 2014, the official website of the Florida Board of Nursing, on its "General FAQs" (Frequently Asked Questions) web page, contained the following question and answer: Can a practical or registered nurse inject Botox? The injection of Botox is not within the scope of practice for practical or registered nurses and does not constitute the administration of medication. On October 24, 2014, the official website of the Florida Board of Nursing, on its Search Results web page, when the term "Botox" was searched, yielded the following results: Can a practical or registered nurse inject Botox? The injection of Botox is not within the scope of practice for practical or registered nurses and does not constitute the administration of medication. On October 28, 2014, the official website of the Florida Board of Nursing, in its "Help Center" web page, contained the following question and answer: Help Center/Can a practical or registered nurse inject Botox? The injection of Botox is not within the scope of practice for practical or registered nurses and does not constitute the administration of medication. Botox is approved by the U.S. Food and Drug Administration (FDA). Ultimate Facts The Botox statement constitutes a rule within the definition of section 120.52(16). The Botox statement, or a substantially similar statement, has not been adopted as a rule under chapter 120 procedures. The Board of Nursing did not show that it is not practicable or feasible to adopt the Botox statement as a rule.
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint December 19, 2005, 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: 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. (2009). 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. (2009). At the times pertinent to this proceeding, Dr. Achong was a physician licensed by the State of Florida, having been issued license number ME38304, and his medical office was located at 690 East 49th Street, Hialeah, Florida. Dr. Achong specialized in obstetrics and gynecology, although he was not board-certified in these areas of practice. Dr. Achong has not previously been the subject of disciplinary action by the Board of Medicine, and he is not currently practicing medicine, having retired with a disability in 2006. At the times pertinent to this proceeding, Dr. Achong had hospital privileges at Hialeah Hospital and at North Shore Medical Center ("Medical Center"). Both facilities had his home telephone number and his beeper number. It was his practice to keep his beeper close to him at all times. When he was in the delivery room, it was his practice to give his beeper to the circulating nurse, who would be responsible for alerting him whenever someone tried to reach him on his beeper. The beeper he used in 2004 gave only the telephone number of the person trying to reach him, but he was able to recognize the number of Hialeah Hospital and the Medical Center. On February 12, 2004, Patient L.H. went to her gynecologist, Ramon Hechavarria, M.D., for a routine examination. Patient L.H. was, at the time, a 27-year-old who was 32 weeks' pregnant, and she had previously had one live birth. Dr. Hechavarria's examination revealed that Patient L.H.'s blood pressure was elevated, and Dr. Hechavarria admitted her to Medical Center for 24 hours for observation. On February 12, 2004, Dr. Hechavarria ordered blood and laboratory tests done in the Medical Center. The blood tests included a Disseminated Intravascular Coagulopathy ("DIC") profile and a Fibrinogen Degradation Profile ("FDP"); the results of these blood tests were normal. Patient L.H.'s hemoglobin and her platelet count were normal, and, although there was a slight trace of protein in her urine, that is considered normal. On February 13, 2004, Dr. Hechavarria discharged Patient L.H. with a diagnosis of chronic hypertension and a prescription for 250 milligram tablets of Aldomet, to be taken three times per day. Aldomet is a medication that treats hypertension by lowering the blood pressure. Patient L.H. was in good, stable condition when she was discharged on February 13, 2004. Readings from a fetal heart monitor taken during the time Patient L.H. was in the Medical Center indicated that the fetus was alive. Dr. Hechavarria considered Patient L.H.'s to be a high risk pregnancy in part because of her hypertension but also because she came in late for prenatal care, missed two appointments, and was overweight. Dr. Hechavarria left town for a vacation on February 13, 2004, and Dr. Achong was to cover his patients during his absence under an arrangement whereby Dr. Hechavarria and Dr. Achong provided coverage for each other when one or the other was out of town or otherwise unavailable to see patients. Under the arrangement, Dr. Achong was expected to go to the hospital if one of Dr. Hechavarria's patients were in labor or if a patient were to go to the emergency room complaining of vaginal bleeding or any other obstetrical or gynecological condition. Whenever coverage of patients was passing from one physician to the other, Dr. Hechavarria and Dr. Achong advised each other of any patient that was in the hospital for gynecological, obstetrical, or any other medical reason. They did not advise each other of patients that had recently been discharged from the hospital, and, therefore, Dr. Hechavarria did not discuss Patient L.H. with Dr. Achong because she had been discharged from the Medical Center before Dr. Achong began covering Dr. Hechavarria's patients. Patient L.H. presented at the Medical Center at approximately 2:00 a.m. on February 15, 2004, complaining of abdominal pains. She was seen by labor and delivery nurse Jennifer Williams, a registered nurse with 20 years' nursing experience, with 13 years' experience in the Medical Center's labor room, and with training as a mid-wife. Nurse Williams had worked with Dr. Achong at the Medical Center since 1991. Subsequent to Patient L.H.'s arrival at the Medical Center, Nurse Williams interviewed her, took her medical history, examined her, and entered the pertinent information on the Medical Center's Admission Assessment. The Admission Assessment form was dated February 15, 2004, and the time was noted as 2:45 a.m. The time written by Nurse Williams' signature on the Admission Assessment form was 3:00 a.m., and it appears that the information was obtained and entered on the form between 2:00 a.m. and 3:00 a.m. Pertinent to this matter, Nurse Williams maintained several other documents recording Patient L.H.'s condition and observations and actions taken by Nurse Williams relating to Patient L.H. Nurse Williams began maintaining a Labor Flow Record at 2:07 a.m. and she made periodic entries on the Labor Flow Record related to, among other things, Patient L.H.'s vital signs, the results of vaginal examinations and fetal monitoring, uterine activity, and pain intensity at different times during the night and morning. In addition, Nurse Williams entered on the Labor Flow Record the time and content of her communications with Dr. Achong; the first recorded contact between Dr. Achong and Nurse Williams was recorded on the Labor Flow Record as 2:30 a.m. Nurse Williams also maintained Progress Notes in which she recorded her observations of Patient L.H. and her conversations with Patient L.H. The first entry in the Progress Notes was at 2:35 a.m.2 Nurse Williams' Progress Notes reflect that, at 2:35 a.m., Patient L.H. advised Nurse Williams that she had contractions and believed she had been in labor since 6:00 p.m. the previous evening but had waited to come to the Medical Center until she was certain she was in labor. Patient L.H. also reported abdominal pain in her upper abdomen that did "not go away," and Nurse Williams observed that Patient L.H. was distressed by the pain in her abdomen. Patient L.H. also told Nurse Williams that she had no ruptured membranes or vaginal bleeding. Nurse Williams noted that she examined Patient L.H. and felt contractions but was unable to detect a fetal heart tone. Nurse Williams reported in the Admission Assessment form that Patient L.H. was having uterine contractions of moderate intensity and 60 seconds' duration, that her cervix was dilated 1-to-2 centimeters, that she had vaginal bleeding that was bright red, that her blood pressure was 159/118, which she described as "elevated," and that Patient L.H.'s abdominal pain was the "worse" pain on a pain scale ranging from 1 to 10; there is, however, no indication on the Admission Assessment form that the pain was constant. Nurse Williams also noted on the Admission Assessment form that she heard no fetal heart rate. Although the time noted on the Admission Assessment form was 2:45 a.m., it is apparent from a review of the relevant records that the information included on the Admission Assessment form was obtained by Nurse Williams over a period of time extending from the time Patient L.H. presented to her until 3:00 a.m., the time on the Admission Assessment form beside Nurse Williams' signature. Nurse Williams reported in the "Physician /CNM in/Called Report" section of the Labor Flow Record that she contacted Dr. Achong at 2:30 a.m. and conveyed to him the following information: "[P]atient arrived in ER c/o contractions since 6 pm last night & observation that no FHT [fetal heart tone] and contractions palpated." Nurse Williams telephoned Dr. Achong using his home telephone, even though his beeper number was also on file at the Medical Center. There is nothing in the report Nurse Williams gave to Dr. Achong at 2:30 a.m. that would require that he proceed to the Medical Center and examine Patient L.H., and he did not violate the standard of care by failing to do so. Because Dr. Achong did not know Patient L.H., Nurse Williams' normal procedure would have been to advise Dr. Achong of Patient L.H.'s history, including the medications she was taking, and her vital signs, including her blood pressure. No notation appears in the Labor Flow Record to confirm that she gave Dr. Achong this information during her conversation with him at 2:30 a.m., nor is there a notation in the 2:30 a.m. entry in the Labor Flow Record that Nurse Williams told Dr. Achong about the results of her examination of Patient L.H.'s cervix, Patient L.H.'s complaint of abdominal pain, or the presence of vaginal bleeding of bright red blood.3 Nurse Williams indicated in her entry in the "Physician/CNM in/Called Report" section of the Labor Flow Record that Dr. Achong ordered a "stat," or expedited, obstetrical sonogram during the 2:30 a.m. contact with Nurse Williams. The purpose of the obstetrical sonogram was to determine if the fetus was alive. Although not noted in the Labor Flow Record, the Labor and Delivery Orders form completed by Nurse Williams indicates that, at 2:30 a.m., Dr. Achong ordered a complete blood count, which is routine with a patient in labor; a DIC profile; and a Comprehensive Metabolic Panel ("CMP"). The Labor and Delivery Orders form contains standard orders for a woman in labor, but the DIC profile and the CMP tests were not included on the form but were ordered specifically by Dr. Achong. A DIC profile is used to determine if a patient has a problem with blood clotting. The DIC includes an assessment of prothrombin time and partial thromboplastin time, both of which indicate different levels at which a patient's blood is able to clot. It is important to know whether a woman in labor and delivery has a clotting problem, or coagulopathy, because of the danger of bleeding, and the classic situation in which DIC profiles are ordered is when there is fetal demise. Because Patient L.H. had the high risk factors of overweight and hypertension and because Nurse Williams could detect no fetal heart tone, Dr. Achong's order for the DIC profile was appropriate and met the standard of care. It is also appropriate to order a DIC profile when there is a concern about placental abruption, which is the separation of the placenta from the walls of the vagina. A placental abruption causes a great deal of bleeding, and can cause death when not treated, because the fetus is still in the womb and the uterus is not able to contract and constrict the large blood vessels that attach to the placenta. Although hypertension is one risk factor for placental abruption, the symptoms of placental abruption also include fetal demise, bleeding, constant pain, a decrease in hematocrit, and a number of other conditions. There is no indication in Patient L.H.'s medical records that Dr. Achong had sufficient information at 2:30 a.m. that would indicate that Patient L.H. had a possible placental abruption, and he ordered the DIC profile because of the lack of fetal heart tones.4 The CMP includes tests for kidney and liver function and for uric acid. It is used to determine if a woman has pre-eclampsia, or pregnancy-induced hypertension. Given Patient L.H.'s history of hypertension and the level of her blood pressure as reflected in the Admission Assessment form, Dr. Achong's order for the CMP was appropriate and met the standard of care in ordering the CMP. All orders for blood tests for women in labor and delivery are treated as "stat" orders and are processed ahead of all other test orders except those from the emergency room. When the situation warrants, a physician may order that the tests be performed more quickly than the usual "stat" order would require, and it would be possible to obtain blood-test results within 45 minutes. There is, however, no indication in Patient L.H.'s medical records that Dr. Achong had any information at 2:30 a.m. that might indicate that he should further expedite Patient L.H.'s blood tests. Nurse Williams reported in her Progress Notes that, at 2:40 a.m., Patient L.H. reported a "gush of something down there," and Nurse Williams noted that she observed a large amount of blood; there is, however, no notation in the Progress Notes regarding the color of the blood. Nurse Williams also included a notation in the Progress Notes that Patient L.H.'s cervix was "3cm dilated, 50% effaced, -3 station" to describe the progress of Patient L.H.'s labor. Nurse Williams reported in the Labor Flow Record that she contacted Dr. Achong at 2:45 a.m. and conveyed to him the following information: "Dr. Achong notified of gush of vaginal bleeding. VE [vaginal examination] 2-3, 50% effaced, -3 station and that we are awaiting sonogram." The results of Nurse Williams' vaginal examination of Patient L.H. showed that Patient L.H. was in active labor. The information that Patient L.H. experienced a "gush of vaginal bleeding" did not indicate to Dr. Achong that there was anything more than one episode of bleeding, which he attributed to an especially heavy "bloody show," which is the bleeding that occurs when the cervix is dilating. The notation indicates that Dr. Achong told Nurse Williams to call him if Patient L.H. went to delivery. The information conveyed to Dr. Achong at 2:45 a.m., as reflected in the notation in the Labor Flow Record, was not sufficient to indicate that Patient L.H. was not proceeding through labor normally to a vaginal delivery of the dead fetus, which is preferred over delivery by a Cesarean Section. Nurse Williams did not include in her records a notation that she advised Dr. Achong that the "gush of vaginal bleeding" consisted of a large amount of bright red blood, which would have been an indication of a possible placental abruption. Some bleeding is normal during labor, but it is usually a dark color from having been in the uterus and in a small amount or tickle, although there could be a "gush of blood" during normal labor. When Dr. Achong was advised by Nurse Williams that Patient L.H. had a "gush of blood," however, it was his responsibility to inquire into the amount of blood, the color of the blood, and the persistency of the bleeding to determine if Patient L.H. was proceeding with normal labor or if she was experiencing a hemorrhage or other abnormal condition. Nurse Williams made no entries in the Progress Notes for Patient L.H. between 2:40 a.m. and 3:40 a.m., when she reported that the ultrasound had been completed. She further noted in her Progress Notes: "Report of no fetal heart tones to Dr. Achong. Orders given." Nurse Williams additionally made a notation in the Labor Flow Record that, at 3:40 a.m., she contacted Dr. Achong and reported to him the following: "Ultrasound report No FHT's given to Dr. Achong. Orders received." Nurse Williams did not, however, indicate in her notations what orders were given. Nurse Williams contacted Dr. Achong through his home telephone number, which was normal procedure during the nighttime hours. When the sonographer, that is, the person performing the sonogram, entered Patient L.H.'s room to perform the sonogram, he noted that Patient L.H. was sitting upright in bed, was combative, and was in a lot of pain. He also noted that there was a fair amount of blood on the bed sheets. The sonographer was able to get Patient L.H. to lie on the bed, and he performed "a very short ultrasound,"5 and pulled the machine out of the room and into the hall. He powered the machine back up and read the numbers off the worksheet on the machine. He confirmed that the fetus was dead and that the placenta appeared to be balled up rather than lying smoothly against the uterine wall, as is normal. While he was writing down the information from the worksheet on the machine, Nurse Williams approached him and told him that she had Dr. Achong on the telephone. He told her that he had "a placental abruption and fetal demise."6 He then wrote up his report, left a copy for Nurse Williams, and went downstairs to process the sonogram images.7 The results of the sonogram were reported on a form headed "Obstetrical Preliminary Report," which was completed by the sonographer. A radiologist is usually present at the Medical Center during daytime hours to read sonograms, but on the off-hours, it is the practice of the sonographer to present a sonographer's impression of what was seen during the sonogram. The sonographer who performed the sonogram on Patient L.H. noted on the report that her history included obesity, hypertension, heavy vaginal bleeding, and contractions. He included the following comments in the report: "Ant/Rt [unintelligible] placenta appears to be 'balled up[.]' Suggestion of placental abruption," and, on a separate line, "NO FETAL HEART MOTION SEEN PT IS COMBATIVE." Finally, at the bottom of the report, the sonographer noted that a copy of the report was given to Nurse Williams. There was no notation as to the time the sonographer gave the report to Nurse Williams, but, even if she had the report, she did not read it to Dr. Achong; rather, she put the copy of the report in Patient L.H.'s chart for Dr. Achong to review when he came to the hospital and gave him only a verbal report. Nurse Williams did not tell Dr. Achong during the 3:40 a.m. telephone conversation that the sonographer had reported a possible placental abruption.8 Dr. Achong was familiar with and had treated placental abruptions prior to February 15, 2004, and he always treated patients with placental abruptions on an emergency basis because both the mother and the baby could die if treatment was not received as soon as possible. Had Nurse Williams advised Dr. Achong that the sonographer had told her that he found a placental abruption or that the sonogram report included a reference to a possible placental abruption, he would have gone to the Medical Center immediately. At 3:45 a.m., Nurse Williams noted in her Progress Notes that she gave Patient L.H. Nubain and Phenergan for her painful contractions. There is no mention of continued vaginal bleeding in this entry in the Progress Notes. At 4:15 a.m., Nurse Williams noted in her progress notes that Patient L.H. was sleeping quietly and was relaxed and that Pitocin had been administered in accordance with Dr. Achong's orders. Pitocin is used to induce labor, augment labor, or to stop bleeding. In this case, Dr. Achong ordered the Pitocin to regulate Patient L.H.'s contractions. There is no mention in the 4:15 a.m. entry in the Progress Notes of continued vaginal bleeding. The next entry in Nurse Williams' Progress Notes was made at 5:15 a.m., when Nurse Williams reported that she had observed vaginal bleeding, that a vaginal examination showed dilation of four centimeters, and that Patient L.H. was very restless and moving around the bed. Nurse Williams received the laboratory report showing the results of the blood tests ordered by Dr. Achong at or around 5:00 a.m. According to the laboratory report, the blood for these tests was drawn at or about 3:20 a.m.; the report did not show any critical values in the blood sample. Nurse Williams attempted to contact Dr. Achong to convey these results to him. She noted on the Labor Flow Record that, at 5:15 a.m. "Dr. Achong beeped re lab results. Phone message left on home phone to call LR [Labor Room]." Nurse Williams made another entry on the Labor Flow Record that, at 6:55 a.m., she left a "message to Dr. Achong answering machine at home re labor progress update and labs." Dr. Achong was not, however, at home to receive the telephone calls or the messages. At or about 5:00 a.m. on February 15, 2004, Dr. Achong received a telephone call on his home telephone from Hialeah Hospital advising him that one of his patients or one of Dr. Hechavarria's patients was in active labor and about to deliver. Shortly after receiving the telephone call, Dr. Achong left his home to travel to Hialeah Hospital. He carried his beeper with him, but he did not receive any calls on the beeper. When he arrived at Hialeah Hospital and prepared to go into the delivery room, he gave it to the circulating nurse in case he should receive a beeper call while he was in the delivery room. Nurse Hayes, who had replaced Nurse Williams when Nurse Williams' shift had ended at 7:00 a.m., made a notation on the Labor Flow Record that, at 7:15 a.m., she called Dr. Achong and left a message. At 7:25 a.m., while he was in the delivery room, Nurse Hayes called his beeper. The circulating nurse had his beeper, and she notified him that he had received a call and told him the number. He recognized the number of the Medical Center, and he told the nurse to call the Medical Center and let them know that he was in the delivery room at Hialeah Hospital. Nurse Hayes asked that he call back as soon as possible. Blood for additional blood tests was drawn at or about 7:30 a.m., and the results, which were available within 15 minutes, showed several critical values that indicated that Patient L.H. was entering coagulopathy. At 7:38 a.m., as soon as he finished the delivery, he called the Medical Center and spoke with Nurse Hayes, who gave him a report on the status of Patient L.H. She told him that Patient L.H. had heavy bleeding and that the vaginal examination showed no change in the cervix. Dr. Achong ordered the Pitocin turned off. When Dr. Achong arrived at the Medical Center at 7:56 a.m., he found Patient L.H. very combative, bleeding, and with very bad vital signs. He ordered a "stat" Cesarean Section and ordered a blood transfusion. Patient L.H. died at 8:38 a.m., before any of the measures ordered by Dr. Achong could be implemented. The cause of death was recorded as placental abruption. Summary In summary, the evidence presented by the Department is not of sufficient weight to establish that Nurse Williams conveyed to Dr. Achong the information necessary for him to conclude that he should personally conduct a clinical evaluation of Patient L.H.; that he should consider the possibility that Patient L.H. had placental abruption; or that he should have provided medical assistance to Patient L.H. prior to his contact with Nurse Hayes at 7:38 a.m. Nurse Williams' Progress Notes report only two remarkable items: There were no fetal heart tones detected by physical examination or by sonogram; and, at 2:40 a.m., Patient L.H. reported a "gush of something" and Nurse Williams observed a large amount of blood. Neither Nurse Williams' entries in the Labor Flow Record regarding her contacts with Dr. Achong nor her testimony, to the extent that it has been found persuasive, is sufficient to establish that she advised Dr. Achong that she had observed a large amount of red blood at 2:40 a.m. or that the sonographer detected a possible placental abruption in the sonogram. Finally, Nurse Williams did not follow the protocol that required her to contact Dr. Achong through his beeper when she did not get an answer on his home telephone; she tried his beeper only once, at 5:15 a.m., and when she failed to reach him, left three messages on his home telephone. The Department presented no evidence to establish that Nurse Williams attempted to reach Dr. Achong by beeper between 5:15 a.m. and 7:55 a.m., the time of her last call to Dr. Achong's home telephone. Furthermore, the Department did not present evidence of sufficient weight to establish that Dr. Achong failed to initiate the appropriate procedures after he arrived at the Medical Center and examined Patient L.H. at or around 8:00 a.m. The evidence presented by the Department is, however, of sufficient weight to establish that Dr. Achong should have questioned Nurse Williams further when she advised him at 2:45 a.m. that she had observed a "gush" of vaginal bleeding. Even though vaginal bleeding may not be not unusual during labor, a report of a "gush" of blood should have alerted Dr. Achong to a potential problem. Although a physician practicing obstetrics is meeting the standard of care when relying on labor room nurses to advise him or her of the clinical status of labor and delivery patients and of any unusual symptoms exhibited by the patients, it is also incumbent on the physician to inquire further if a patient is presenting unusual symptoms. The persuasive evidence establishes that Dr. Achong violated the standard of care when he failed to ask Nurse Williams for additional information on Patient L.H.'s status during their 2:45 a.m. telephone conversation. Had he inquired further, Dr. Achong would have been alerted to the possibility that Patient L.H. had a placental abruption and would have gone to the hospital to provide appropriate care for Patient L.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order finding that Dr. Achong violated Section 458.331(1)(t), Florida Statutes, by failing to elicit further information from Nurse Williams regarding the gush of blood she observed in Patient L.H and imposing the following penalties: Issuance of a letter of reprimand; Imposition of administrative fine in the amount of $2,500.00; and Six months' probation under such conditions as the Board of Medicine determines appropriate, should Dr. Achong ever resume the practice of medicine. DONE AND ENTERED this 4th day of January, 2010, in Tallahassee, Leon County, Florida. 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 4th day of January, 2010.
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 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 Braylon Roberts was born on February 3, 2009, at St. Joseph’s Women’s Hospital located in Tampa, Florida. Braylon’s birth weight exceeded 2,500 grams. Donald Willis, M.D. (Dr. Willis), was requested by NICA to review the medical records for Braylon. On July 1, July 9, and August 18, 2014, Dr. Willis performed a medical records review and wrote medical reports. In an affidavit dated December 29, 2014, he summarized his records review and opined as follows: In summary, labor was induced at term with an uncomplicated spontaneous vaginal delivery. The newborn was not depressed and required no resuscitation after birth. Hospital course was uneventful until DOL 2 when seizure activity was noted. MRI was consistent with cerebral stroke. The baby suffered a cerebral stroke at some time on DOL 2. Medical history of a normal spontaneous vaginal birth with no newborn depression and a normal initial newborn hospital course, suggests the stroke was not due to oxygen deprivation or mechanical trauma during labor, delivery or in the immediate post-delivery period. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor, delivery or the immediate post-delivery period. The additional records do not change any of the opinions expressed in the letter of 07/01/2014. The FHR monitor tracing does not suggest fetal distress during labor. This would be in agreement with the previous opinion that the newborn stroke did not result from oxygen deprivation during labor. NICA retained Raymond J. Fernandez, M.D. (Dr. Fernandez), a pediatric neurologist, to examine Braylon and to review his medical records. Dr. Fernandez examined Braylon on October 6, 2014. In a medical report regarding his independent medical examination of Braylon, Dr. Fernandez opined as follows: Braylon has a subtle (very mild) right hemiparesis that is not causing substantial motor impairment at this time and it is not predicted not [sic] to cause substantial motor impairment in the future. Speech is mildly to moderately delayed, but improving and he is improving with regard to basic learning skills in his regular kindergarten classroom setting. The ultimate outcome with regard to more complicated learning is indeterminate at this time, but he should continue to improve with appropriate input from teachers and family members. Braylon’s neurological injury was due to an ischemic stroke in the distribution of a branch of the left middle cerebral artery. His neurological injury was not caused by oxygen deprivation or mechanical injury due to an obstetrical event during labor, delivery, or in the immediate post delivery of [sic] resuscitation. Dr. Fernandez confirmed his opinion in an affidavit dated January 7, 2015.1/ A review of the file in this case reveals that there have been no expert opinions filed that are contrary to the opinion of Dr. Willis that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby's brain during labor, delivery, or the immediate post- delivery period. Dr. Willis’ opinion is credited. There are no contrary expert opinions filed that are contrary to Dr. Fernandez’s opinion that although Braylon has a subtle (very mild) right hemiparesis, it is not causing, and is not predicted to cause, substantial motor impairment. Further, Dr. Fernandez also opined that Braylon’s neurological injury was not caused by oxygen deprivation or mechanical injury due to an obstetrical event during labor, delivery, or in the immediate post-delivery or resuscitation. Dr. Fernandez’s opinion is credited.
