The Issue Whether Respondent should be determined to be found in violation of Florida's Medical Practice Act for gross negligence or failure to practice medicine with that level of care, skill, and treatment recognized by a reasonably prudent similar physician as being acceptable under the circumstances or for _ ) failure to keep written medical records justifying the course cf treatment of a patient throughout seven months of her pregnancy? ( If so as to either charge, what is the appropriate discipline to be imposed by the Board of Medicine?
Findings Of Fact The Parties Petitioner, the Agency for Health Care Administration, is within the Department of Business and Professional Regulation, together with the Board of Medicine, the regulatory authority charged with regulating the practice of medicine in the State of Florida. Section 20.42 and Chapter 458, Florida Statutes. Respondent, Neville Clement Jack, M.D., is the holder of a license to practice medicine in Florida, license number ME 0046020. Prior Discipline by the Board of Medicine .. While holding license number ME 0046020, Dr. Jack has ) been disciplined twice by the Board of Medicine. He was first disciplined by a final order dated August 26, 1994. He had been charged by administrative complaint with ( violating Section 458.33l(l)(c), Florida Statutes, in that he had entered a plea of nolo contendere in the Thirteenth Judicial Circuit Court for Hillsborough County to seven counts of petit theft. The plea was based on criminal charges in which he was accused of defrauding Medicaid of $11,227.00 by billing Medicaid for services he had not provided. Dr. Jack did not contest the factual allegations in the administrative complaint. Dr. Jack was fined $2,500.00 and ordered to subject his practice to procedures designed to achieve quality assurance in the practice. Dr. Jack was disciplined again by a final order entered December 13, 1995. In this second proceeding, Dr. Jack was charged with twelve counts of violating the disciplinary C provisions of Chapter 458, Florida Statutes. Six of the counts charged Dr. Jack with failure to practice medicine with reasonable safety, two charged him with medical records violations, one with making deceptive representations in the course of his practice and one with inappropriate prescription of legend drugs. In entering a consent order with the Agency for Health Care Administration, Dr. Jack neither admitted nor denied the charges. The final order disposed of the case by fining him $5,000 and placing him on probation for a two year period effective December 5, 1995. Of the seven cases of patients whose treatment by Dr. Jack led to the twelve counts of violations of the Medical Practice Act in the administrative -"- ) complaint, issued in this second proceeding, three -cases, in part, consist of charges involving failure to respond to telephone calls or pages in a timely manner; three also consist of charges Dr. Jack failed to be present at critical moments in obstetrical care, including delivery, and follow-up or postpartum care. Failure to respond to pages or telephone calls at critical moments of need by an obstetrical patient is at the heart of this case, a case involving prenatal care of A.W., a woman who had entrusted her first pregnancy to Dr. Jack. Patient A. W.'s Obstetrical Care Prior to October 1992 In early 1990, Dr. Jack admitted a new patient to his practice of gynecology: A.W. Dr. Jack and A.W. had know each other prior to establishment of their physician-patient relationship because they were members of the same church. A little more than two years later, when Patient A.W. suspected that she might be pregnant, she made an appointment with Dr. Jack's office. If pregnant as she suspected, A.W. thought Dr. Jack would be the ideal person to provide her with obstetrical care. She been his gynecological patient for more than two years. In addition, she had known him for some time and had always believed him to be a reputable physician. In fact, she had seen Dr. Jack's name listed in her Humana provider publication as both a gynecologist and an obstetrician. In addition to thinking Dr. Jack would be an ideal obstetrician for prenatal care and delivering the baby, A. W., ) knew that if she were pregnant, she did not want the baby to be delivered a birthing center. She wanted the baby to be delivered at a hospital by a reputable obstetrician. In her mind, Dr. Jack was that obstetrician. He was the obstetrician whom she felt she could trust with a moment extremely important to her and her child-to-be: the baby's birth. A.W. presented to Dr. Jack's office on May 8, 1992 with indications of pregnancy. Dr. Jack conducted a full physical examination of her, including a sonogram. She was diagnosed as pregnant with an expected delivery date of December 21, 1992. Dr. Jack accepted A.W. as a prenatal patient. Unbeknownst to A. w., however, Dr. Jack, in May of 1992, did not have privileges at any hospital. He was not able and knew he was not able, therefore, to deliver A. W.'s baby at a hospital. It is not clear from the record why Dr. Jack did not have privileges at any of the local hospitals. It may have been because he had been convicted of seven criminal counts of petit theft involving medicaid fraud. It may have been because of the charges in the two cases for which he was disciplined several years later by the Board of Medicine. Whatever the basis for the loss of privileges, however, the fact remains: from the moment A.W. presented in May of 1992 throughout the course of care he provided A.W. while she was pregnant, Dr. Jack did not have privileges at any local hospital at which he could have delivered A.W.'s baby. At her initial visit the time most appropriate for the information to be communicated to a pregnant woman, A.W. was ' - \ not informed by either Dr. Jack's office staff or Dr. Jack, himself, that Dr. Jack did not have privileges at a local hospital. Nonetheless, for th·e next few months, A.W.'s pregnancy and prenatal care proceeded uneventfully. Dr. Jack provided A.W. with appropriate prenatal care, such as checking fetal heart tone, analysis of weight gain, checking growth of the fetus by measuring the patient's abdomen, and performing urinalyses. But, Dr. Jack did not refer A.W. to an obstetrician for the expected delivery. And A.W., not knowing that Dr. Jack could not conduct the delivery at a hospital, made no attempt to contact an obstetrician. During several of the visits to Dr. Jack's office prior to October of 1996, A.W. made known her intention to have ) the baby delivered at University Community Hospital ("UCH") in discussions with Dr. Jack's staff. It may be that staff members who participated in these discussions thought A.W. had been informed as part of standard office procedure of the lack of Dr. Jack's privileges. But, such procedure had not been followed in the case of A.W. At none of the times A.W. discussed delivery at UCH did the staff inform A.W. that Dr. Jack did not have privileges at UCH or, for that matter, at any other hospital in the area. Neither did Dr. Jack inform her of the status of his privileges at local hospitals. A.W.'s pregnancy continued to·proceed uneventfully until mid-October. ) Prenatal Care in October and November, 1992 On October 16, 1996, A.W., then close to commencement of her eighth month of pregnancy, presented to Dr. Jack with complaints of a urinary tract infection. Two weeks later, she presented a second time with symptoms which Dr. Jack diagnosed as a urinary tract infection and for which he prescribed Bactrim. Dr. Jack saw A.W. for the infection on November 2, 9 and 11, 1992. Following the November 2 office visit, Dr. Jack prescribed Amoxicillin. Following the November 9 visit, he prescribed Amoxicillin again. On November 11, 1992, Dr. Jack ordered a culture to determine the origin of the infection because A.W. was not responding to the prescribed antibiotics. On one of these visits, little more than one month prior to the expected delivery of the baby, Aw. was accompanied ( by W.W., her husband. W.W. expressed to Dr. Jack his concern about the antibiotic treatment received by A.W. and asked why she wasn't being hospitalized. W.W. thought his wife should be monitored in a hospital since the infection had lingered so long and seemed serious. W.W. was especially concerned since the infection was occurring while A.W. was experiencing a first-time pregnancy. The meeting between A.W., W.W., and Dr. Jack lasted twenty minutes. At no time during the meeting did Dr. Jack inform W.W. that he did not have privileges at any hospital. Nor did Dr. Jack inform W.W. that he was providing prenatal care only and that it was going to be necessary for him and his wife to obtain an obstetrician for the delivery. On November 13, 1996, A.W. saw Dr. Jack at his office again in order to have performed a sonogram, a procedure standard near the commencement of the last month of a full-term pregnancy. At the November 13 office visit, the staff informed A.W. that Dr. Jack "was not delivering right now, so ... he had other doctors who were delivering for him." Tr. 29. This was the first time that A.W. had ever heard or been informed that Dr. Jack did not have hospital privileges and would not be delivering the baby. When asked whether she wanted the delivery at UCH or another hospital, A.W., consistent with her earlier discussions with Dr. Jack's staff, answered UCH. In response, Dr. Jack's ) staff told A.W. that an appointment would be made in the first week of December for A.W. to see Dr. Reimer, an obstetrician with privileges at UCH. Consistent with the default up until November 13, 1992, by Dr. Jack and his staff in informing A.W. of his lack of privileges, Dr. Jack's records do not reflect that he ever informed A.W. that he did not have privileges. Likewise, on the November 13, 1992, when A.W. was finally and for the first time informed of the status of his privileges, Dr. Jack's records do not reflect that A.W. was informed. In light of the revelation on November 13, 1992, that Dr. Jack would not be delivering her baby, A.W. accepted the appointment made for her with Dr. Reimer. It was not A.W.'s \ // independent decision, however, to avail herself of Dr. Reimer's obstetr ical care at this late stage in her pregnancy. The decision to accept the appointment was thrust upon A.W. by the ( circumstances of the late revelation of the status of Dr. Jack's privileges. A.W made none of the arrangements to see Dr. Reimer. The arrangements were handled solely by Dr. Jack's staff. A.W. was told by Dr. Jack's staff that her records were being copied and sent to Dr. Reimer. Contrary to this representation, however, none of A.W.'s records were transmitted to Dr. Reimer's office. Obstetrical Care in December 1992 On the day of her appointment with Dr. Reimer during the first week of December, A.W. attempted to see Dr. Reimer but she could not find his office. She went to Dr. Jack's office for directions but, by the time she reached his office, the time ( for the appointment with Dr. Reimer had passed. A.W. had an appointment scheduled with Dr. Jack for the upcoming Friday afternoon, December 4, at 3:30. Dr. Jack's staff made a second appointment with Dr. Reimer for one hour before: 2:30 p.m., the afternoon of December 4. With the benefit of the new directions, A.W. found Dr. Reimer's office in time for her 2:30 appointment that Friday afternoon. Dr. Reimer's office refused, however, to allow A.W. to see Dr. Reimer because it did not have her prenatal records or any other medical records of hers. A.W. returned to the office in order to obtain the records, herself, and to transport them back to Dr. Reimer's office. In addition she intended to ( --, see Dr. Jack for her 3:30 appointment. When she arrived at the ) Dr. Jack's office, however, it was closed. A.W. attempted to reach Dr. Jack by telephone in the hope that his answering service would be able to inform him of the need to return her call, but this attempt, too, proved unsuccessful. At hearing, A.W. described her predicament on the afternoon of December 4, 1992, in the ninth month of her pregnancy and little more than two weeks from the expected birth of her child, in response to the question, "[h]ow were you feeling on that day?" A bit heavy [and in slight discomfort] and I just knew it was three weeks I hadn't seen a doctor, and I knew I had to see somebody if Dr. Reimer didn't see me ... (Tr. 32.) ) December 5, 1992 In the early morning of December 5, A.W.'s slight discomfort of the day before had become abdominal pain. At approximately 7 a.m., A.W. made the first telephone call of many calls she made throughout the day to Dr. Jack's office. As the day wore on with no response from Dr. Jack, the pain grew worse. Finally at 5 p.m., Dr. Jack returned the call. Over the telephone, Dr. Jack diagnosed A.W.'s condition as false labor. After the diagnosis by telephone, the abdominal pain continued to grow worse until it became excruciating. At approximately 8:50 p.m., A.W. reached Dr. Jack by telephone and told him that she wanted to go_ to the hospital. At this moment of A.W.'s worsening condition and what certainly sounded from A.W.'s description of symptoms to be a serious situation, Dr. Jack responded by telling her to call Dr. Reimer. In response to a question on direct examination about whether Dr. Jack had met the standard of care in this case, the agency's expert witness, Dr. Pierre Bouis, testified, that to meet the standard of care an obstetrician not able to deliver must "do everything possible to make sure that the patient is cared for by an appropriate facility and/or physician." (Tr. 140.) Without the required standard of care, that is without any assurance whatsoever of being cared for by an appropriate physician, A.W. presented to the emergency room at UCH at 9:00 C p.m. She asked the attendants to call Dr. Reimer. Dr. Reimer was called but because he had not seen A.W. and did not have any of her records, he declined to come to the hospital. Nurses at UCH examined A.W. Observing that her abdomen was very hard and unable to detect a fetal heart tone, the nurses called Dr. Commedore, the emergency on-call obstetrician for UCH. Dr. Commedore admitted A.W. to UCH and conducted an examination. There were no fetal heart tones. Furthermore, after conducting ultrasound at bedside and other diagnostic procedures, Dr. Commedore detected no fetal movement. Dr. Commedore diagnosed A.W. as having suffered abruptio placenta, premature separation of a normally implanted placenta. Abruptio placenta places an unborn child in great jeopardy because of loss of oxygen in the baby's bloodstream. A Cesarean section was performed after the failure of ) inducement of labor. Dr. Commedore delivered a stillborn baby boy. An autopsy revealed the stillborn child to have no congenital abnormalities, a normal three vessel umbilical cord and lungs with congestion and meconium aspiration. Abruptio placenta suffered on December 5, 1992, a day spent by A.W. beginning at 7 in the morning until 5 p.m. that evening trying to contact Dr. Jack, had caused the stillbirth of the child of A.W. and W.W.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: that the Board of Medicine enter a final order finding Respondent to have violated both paragraphs (m) and (t) of Subsection 456.331(1), Florida Statutes and revoking his license to practice medicine. If the Board should choose a penalty less severe than revocation, Dr. Jack should be prohibited from practicing obstetrics, including the provision of prenatal care, for the remainder of his practice as a physician licensed by the Board of Medicine. DONE AND ENTERED this 24th day of December, 1996, in Tallahassee, Leon County, Florida. - , v--z (fLJiL. - ClvID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of December, 1996. COPIES FURNISHED: Steven Rothenberg, Esquire Agency for Health Care Administration 9325 Bay Plaza Blvd., Suite 210 Tampa, Florida 33619 Neville Clement Jack, M.D. 6814 Rosemary Drive Tampa, Florida 33625 Dr. Marm Harris E ecutive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792 )
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
Conclusions Having reviewed the administrative complaint dated June 12, 2009, and Notice of Intent dated July 9, 2009, attached hereto and incorporated herein (Ex. 1 and 2), and all other matters of record, the Agency for Health Care Administration (“Agency”) has entered into a Settlement Agreement (Ex. 3) with the other party to these proceedings, and being otherwise well- advised in the premises, finds and concludes as follows: 1 Filed November 20, 2009 10:37 AM Division of Administrative Hearings. ORDERED: 1. The attached Settlement Agreement is approved and adopted as part of this Final Order, and the parties are directed to comply with the terms of the Settlement Agreement. 2. The administrative fine against the Respondent in AHCA Case No. 2009001632 is withdrawn. 3. The Respondent's abortion clinic license is cancelled. 4. The initial application seeking laboratory licensure in Case No. 2009007700 is withdrawn. 5. The Respondent's request for formal hearing is dismissed. 6. Each party shall bear its own costs and attorney’s fees. 7. The above-styled cases are hereby closed. DONE and ORDERED this _// day of hover Ake , 2009, in Tallahassee, Leon County, Florida. El . Arnold, Secretary Y t Health Care Administration Thomas Agenc A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Jan Mills Facilities Intake Unit Agency for Health Care Admin. (Interoffice Mail) Thomas M. Hoeler, Esquire | Office of the General Counsel Agency for Health Care Admin. (Interoffice Mail) Laura MacLafferty, Unit Manager Hospital and Outpatient Services Unit Agency for Health Care Admin. (Interoffice Mail) Andrew T. Lavin, Esquire Navon & Lavin, P.A. Emerald Park Office Center 2699 Stirling Road, Suite B-100 Fort Lauderdale, Florida 33312 (U.S. Mail) Karen Rivera, Unit Manager ‘| Laboratory Unit Agency for Health Care Admin. (Interoffice Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of this Final Order was served on the above-named person(s) and entities by U.S. Mail, or the method designated, on this the /8 day of AGI A , 2009. Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 922-5873 Certified Mail Receipt (7003 1010 0000 9715 3702) STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, AHCA No.: 2009001632 vs. COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC., Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “AHCA”), by and through the undersigned counsel, and files this Administrative Complaint. against Community Healthcare Center of Pensacola, Inc. (hereinafter “Community Healthcare Center of Pensacola, Inc.”), pursuant to Section 120.569, and 120.57, Fla. Stat. (2008), alleges: NATURE OF THE ACTION 1. This is an action to impose one (1) administrative fine against Community Healthcare Center of Pensacola, Inc. in the amount of Four Hundred and Thirteen Thousand Dollars ($413.000), based upon one (1) deficiency, pursuant to Section 483.091, Fla. Stat. (2008). EXHIBIT 1. i \ JURISDICTION AND VENUE 2. This Agency has jurisdiction pursuant to 483, Part I and Section 120.569 and 120.57, Fla. Stat. (2008). 3. Venue lies in Escambia County, Pensacola, Florida, pursuant to Section 120.57 Fla. Stat. (2008); Rule 58A-5, Fla. Admin. Code (2008) and Section 28.106.207, Fla. Stat. (2008). PARTIES 4. AHCA, is the regulatory authority responsible for licensure and enforcement of all applicable statutes and rules governing clinical laboratory facilities pursuant to Chapter 483, -Part 1, Fla. Stat. (2008) and Rule 58A-5, Fla. Admin. Code (2008). 5. Community Healthcare Center of Pensacola, Inc. is a for-profit corporation, ABO Group + RH clinical laboratory facility is located at 6770 North Ninth Avenue, Pensacola, Florida 32504. Community Healthcare Center of Pensacola, Inc. is licensed as clinical laboratory facilities license # 800003116; certificate number #60474, effective November 21, 2005 through November 20, 2007. Community Healthcare Center of Pensacola, Inc. was at all times material hereto, licensed facility under the licensing authority of AHCA, and required to comply with all applicable rules, and statutes. COUNTI COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC. BASED ON RECORD REVIEW, OBSERVATIONS AND INTERVIEW WITH THE FACILITY ADMINISTRATOR ON JANUARY 7, 2009, AT APPROXIMATELY 9:30 A.M., IT WAS DETERMINED THAT THE LABORATORY LICENSE AND HAD CONTINUED TO PERFORM LABORATORY TESTING. STATE TAG L001-CLINICAL LABORATORY LICENSE Section 483.091, Fla. Stat. (2007) CLINICAL LABORATORY LICENSE 6. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 7. On or about January 7, 2009, AHCA conducted a biennial survey at the Respondent’s facility. AHCA cited the Respondent based on the findings below, to wit: 8. On or about January 7, 2009, based on record review, observation, and interview with the facility administrator on January 7, 2009, at approximately 9:30 a.m., it was determined that the laboratory had not renewed the State of Florida clinical laboratory license and had continued to perform laboratory testing. 9. Review of state licensure records prior to the survey showed that the facility's laboratory license, number 800003116, had expired on November 20, 2007 and there was no pending application. 10. Review of Rh testing, hematocrit testing records, and pregnancy testing records showed documentation of test results for patient testing that had been performed between November 20, 2007 and January 6, 2009. ll. Observation of the Florida Clinical Laboratory license on display in a frame in the laboratory showed that the license had expired on November 20, 2007. 12. The administrator stated that the laboratory did not have a new state clinical laboratory license and did not realize they had not renewed the Florida license. The administrator stated that the facility had not received the renewal letter prior to the expiration of the license and had not received the "failed to renew" letter from the Agency for Health Care Administration following expiration of the license. Plan of Correction must be completed by February 21, 2009. 13. The regulatory provision of the Florida Statutes and Agency Rules (2008), that are pertinent to this alleged violation read as follows: 483.091 Clinical laboratory license A clinical laboratory may not send a specimen drawn within this state to any clinical laboratory outside the staté for examination unless the out-of-state laboratory has obtained a license from the agency. A new license may be secured for thé new location before the actual change, if the contemplated change complies with this part, part II of chapter 408, and the applicable rules. ek 483.221 Administrative fines.— In determining the penalty to be imposed, the Agency must consider, inter alia, the severity of the violation, actions taken by the licensee to correct the violation, any previous violations by licensee, and the financial benefit to the licensee of committing or continuing the violation. * ko ® 408.804 License required; display.— (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. 408.812 Unlicensed activity.— (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under. this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s. 408.814 and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. 15. Despite being unlicensed, Respondent continued to conduct laboratory testing and continued to reap the financial benefit of conducting said testing. 16. The violation alleged herein constitutes a deficiency, and warrants a fine of $413,000. 17. The Respondent's history of failing to timely renew its license, coupled with Respondent’s performance of unlicensed clinical laboratory testing resulting in financial gain in the face of Agency notification advising of the expiration of the license and the consequences of unlicensed activity, serve as a basis for the instant action and are, inter alia, a consideration of the Petitioner in determining the penalty sought herein. 18. Unlicensed laboratory testing is testing without Agency oversight and may result in substandard laboratory protocols and results which place the health and welfare of Respondent’s patients in danger. 19. The violation alleged herein constitutes a deficiency, and warrants a fine of $413,000. WHEREFORE, AHCA demands the following relief: 1. Enter factual and legal findings as set forth in the allegations of this administrative complaint. 2. Impose a fine in the amount of $413,000. CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida Agency for Health Care Administration requests the following relief: 1. Make factual and legal findings in favor of the Agency on Count I. 2. Impose upon Community Healthcare Center of Pensacola, Inc. an administrative fine in the amount of $413,000 for the violation cited above. 3. Grant such other relief as the court deems is just and proper. Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes (2008). Specific options for administrative action are set out in the attached Election of Rights (one page) and explained in the attached Explanation of Rights (one page). All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to the Agency for Health Care Administration, Building 3, MSC #3, 2727 Mahan Drive, Tallahassee, Florida 32308; Michael O. Mathis, Senior Attorney. RESPONDENT IS FURTHER NOTIFED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT WILL REASULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. Florida. Michael O. Mathis Fla. Bar. No. 0325570 Counsel of Petitioner, Agency for Health Care Administration . Bldg. 3, MSC #3 2727 Mahan Drive Tallahassee, Florida 32308 (850) 922-5873 (office) (850) 921-0158 (fax) CERTIFICATE OF SERVICE L HEREBY CERTIFY, that a true and correct copy of the foregoing has been served by certified mail on pat day of ark , 2009 to Warren Do Taylor, Administrator, Community Healthcare Center of Pensacola, Inc., 6770 North Ninth Avenue, Pensacola, Florida 32504. Michael O. Mathis, Esq. STATE OF FLORIDA : AGENCY FOR HEALTH CARE ADMINIS: RATION RE: Case Name: COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC. CASE NO: 2009001632 ELECTION OF RIGHTS This Election of Rights form is attached to a proposed administrative action by the Agency for Health Care Administration (AHCA). The title may be Notice of Intent to Deny, Notice of Intent to Impose a Late Fee, Notice of Intent to Impose a Late Fine, Administrative Complaint, or some other notice of intended action by AHCA. An Election of Rights must be returned by mail or by fax within 21 days of the day you receive the attached Notice of Intent to Deny, Notice of Intent to Impose a Late Fee, Notice of Intent to Impose a Late Fine, Administrative Complaint or any other proposed action by AHCA. If an election of rights with your selected option is not received by AHCA within twenty-one (21) days from the date you received a notice of proposed action by AHCA, you will have given up your right to contest the Agency’s proposed action and a final order will be issued. PLEASE RETURN YOUR ELECTION OF RIGHTS TO: Agency for Health Care Administration Attention: Agency Clerk 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308. Phone: 850-922-5873 Fax: 850-921-0158. PLEASE SELECT ONLY 1 OF THESE 3 OPTIONS OPTION ONE (1) I admit to the allegations of facts and law contained in the Notice of Intent to Deny, the Notice of Intent to Levy a Late Fee, the Notice of Intent to Levy a Late Fine, the Administrative Complaint, or other notice of intended action by AHCA and I waive my right to object or to have a hearing. | understand that by giving up my right to a hearing, a final order will be issued that adopts the proposed agency action and imposes the penalty, fine or action. OPTION TWO (2) I admit to the allegations of facts contained in the Notice of Intent to Deny, the Notice of Intent to Levy a Late Fee, the Notice of Intent to Levy a Late . Fine, the Administrative Complaint, or other proposed action by AHCA, but I wish to be heard at an informal proceeding (pursuant to Section 120.57(2), Florida Statutes) where I may submit testimony and written evidence to the Agency to show that the proposed administrative action is too severe or that the fine should be reduced. OPTION THREE (3)___ I do dispute the allegations of fact contained in the Notice of Intent to Deny, the Notice of Intent to Levy a Late Fee, the Notice of Intent to Levy a Late Fine, the Administrative Complaint, or other proposed action by AHCA, and I request a formal hearing (pursuant to Section 120.57(1), Florida Statutes (2006) before an Administrative Law Judge appointed by the Division of Administrative Hearings. PLEASE NOTE: Choo ; OPTION THREE (3), by itself, i ‘OT sufficient to obtain a formal hearing. You musi file a written petition in order to obt. «a formal hearing before the ‘Division of Administrative Hearings under Section 120.57(1), Florida Statutes. It must be received by the Agency Clerk at the address above within 21 days of receipt of this proposed administrative action. The request for formal hearing must conform to the requirements of Rule 28-106.201, Florida Administrative Code, which requires that it contain: 1. The name and address of each agency affected and each agency’s file or identification number, if known; 2. Your name, address, and telephone number, and the name, address, and telephone number of your representative or lawyer, if any; 3. An explanation of how your substantial interests will be affected by the Agency’s proposed action; 4. A statement of when and how you received notice of the Agency’s proposed action; ; 5. A statement of all disputed issues of material fact. If there are none, you must state that there are none; . 6. A concise statement of the ultimate facts alleged, including the specific facts you contend warrant reversal or modification of the Agency’s proposed action; 7. A statement of the specific rules or statutes you claim require reversal or modification of the Agency’s proposed action; and 8. A statement of the relief you are seeking, stating exactly what action you wish the Agency to take with respect to its proposed action. Mediation under Section 120.573, Florida Statutes, may be available in this matter if the Agency agrees. Facility type: (ALF? nursing home? medical equipment? Other type?) Facility Name: License number: Contact person(or attorney or representative): Name Title Address: ; Street and number City Zip Code Telephone No. ; Fax No. Email Signed: Date: NOTE: If your facility is owned or operated by a business entity (corporation, LLC, etc.) please include a written statement from one of the officers or managers that you are the authorized representative. If you are one of the managers or officers, please state which office you hold. ‘Entity name: Name of office you hold: You, your attorney or representative may reply according Subsection 120.54 Florida Statutes (2006) and Rule 28, Florida Administrative Code or you may use this recommended form. Lee teoF 70d FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION RN on T Better Health Care for all Floridians Oana N July 9, 2009 CERTIFIED MAIL / RETURN RECEIPT REQUESTED WARREN TAYLOR MD COMMUNITY HEALTHCARE CTR OF PENSACOLA INC LICENSE NUMBER: 800003116 6770 NORTH NINTH AVENUE PENSACOLA, FL 32504-7346 CASE #: 2009007700 NOTICE OF INTENT TO DEEM APPLICATION INCOMPLETE AND WITHDRAWN FROM FURTHER REVIEW Your application for license RENEWAL is deemed incomplete and withdrawn from further consideration pursuant to Section 408.806(3)(b), Florida Statutes, which states that “Requested information omitted from an application for licensure, license renewal, or change of ownership, other than an inspection, must be filed with the agency within 21 days after the agency’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited’’. You were notified by correspondence dated June 05, 2009 to provide further information addressing identified apparent errors or omissions within twenty-one days from the receipt of the Agency’s correspondence. Our records indicate you received this correspondence by certified mail on June 09, 2009. As this requested information was not timely received by the Agency, your application is deemed incomplete and withdrawn from further consideration. The outstanding issues remaining for licensure are: Failure to submit upon written request: e Health Care Licensing Application Addendum with ownership information in Section 2A. EXPLANATION OF RIGHTS Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S., your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. ECTION AND EXPLANATION OF RIGHTS FORMS. Karen Rivera, Manager — . Laboratory Licensure Unit Certified Article Number 7460 3901 9848 4334 8301 SENDERS. RECORD cc: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 2727 Mahan Drive,MS#32 Tallahassee, Florida 32308 h EXHIBIT STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR DOAH No. 09-3585 HEALTH CARE ADMINISTRATION, Petitioner, vs. AHCA No. 2009001632 COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC., Respondent. COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC., Petitioner, vs. AHCA No. 2009007700 STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Respondent. / SETTLEMENT AGREEMENT The State of Florida, Agency for Health Care Administration (“the Agency”), and the licensee/applicant, Community Healthcare Center of Pensacola, Inc. (“the Provider”), pursuant to Section 120.57(4), Florida Statutes, enter into this Settlement Agreement (“Agreement”) and agree as follows: WHEREAS, the Provider is a licensed abortion clinic pursuant to Chapter 408, Part II, Chapter 390, Florida Statutes, and Chapter 59A-9, Florida Administrative Code, and is also an applicant for clinical laboratory licensure pursuant to Chapter 408, Part II, Chapter 483, Part I, Florida Statutes, and Chapter 59A-7, Florida Administrative Code; and WHEREAS, the Agency has jurisdiction by virtue of being the licensiy EXHIBIT Page 1 of 5 authority over the Provider pursuant to the above referenced provisions of law; and WHEREAS, the Agency served an Administrative Complaint dated June 12, 2009, on the Provider; and WHEREAS, the Agency served a Notice of Intent to Deem Application Incomplete and Withdrawn from Further Review (“NOIW”) dated July 9, 2009, on the Provider; and WHEREAS, the parties have agreed that a fair, efficient, and cost effective resolution of this dispute would avoid the expenditure of substantial sums to litigate the dispute; and WHEREAS, the parties have negotiated in good faith and agreed that the best interest of all the parties will be served by a settlement of this proceeding; NOW THEREFORE, in consideration of the mutual promises and recitals herein, the parties intending to be legally bound, agree as follows: 1. All recitals are true and correct, are incorporated into the Agreement and are binding findings of the parties. 2. Upon full execution of this Agreement, the Provider agrees to waive any and all appeals and proceedings to which it may be entitled including, but not limited to, an informal proceeding under Subsection 120.57(2), Florida Statutes, a formal proceeding under Subsection 120.57(1), Florida Statutes, appeals under Section 120.68, Florida Statutes; and declaratory and all writs of relief in any court or quasi-court (DOAH) of competent jurisdiction; and agrees to waive compliance with the form of the Final Order (findings of fact and conclusions of law) to which it may be entitled, provided, however, that no agreement herein shall be deemed a waiver by either party of its right to judicial enforcement of this Agreement. 3. Upon full execution of this Agreement, the Agency agrees to voluntarily dismiss the Administrative Complaint against the Provider with prejudice foregoing the administrative fine sought to be imposed against the Provider in its entirety, and the Provider agrees to: (1) the Page 2 of 5 voluntarily relinquishment of its abortion clinic license (License No. 821) and closure of the abortion clinic effective on or before October 31, 2009, (2) the surrender of the license certificate to the Agency at “Hospital and Outpatient Unit, Agency for Health Care Administration, 2727 Mahan Drive, MS #31, Tallahassee, Florida 32308” immediately upon the discontinuance of the operation of its clinic, (3) the withdrawal of its petition for formal hearing with regard to the pending Administrative Complaint, and (4) the withdrawal of its initial application for clinical laboratory licensure which is the subject of the NOIW. As part of the closure of its clinic, the Provider recognizes that it must comply with all statutes and rules regarding its closure, including but not limited to, Section 408.810 and Section 456.057, Florida Statutes. Until the license is voluntarily relinquished, the Provider recognizes that it must comply with all statutes and rules required by its licensure, including but not limited to, the reporting requirements under Section 390.0112, Florida Statutes, and Rule 59A-9.034, Florida Administrative Code. The Provider agrees to submit a final report for the final month or partial final month of operation, and if unable to do so through the Agency’s on-line system, may do so by United States mail at the above-referenced address. 4. Venue for any action brought to interpret, enforce or challenge the terms of this Agreement and its corresponding Final Order shall lie solely in the Circuit Court of Florida, in and for Leon County, Florida. 5. By executing this Agreement, the Provider does not admit the allegations raised in the Administrative Complaint and NOIW, but recognizes that the Agency continues in good faith to assert these allegations. 6. Upon full execution of this Agreement, the Agency shall enter a Final Order adopting and incorporating the terms of this Agreement and closing the above-styled cases. 7. Each party shall bear its own costs and attorney’s fees. Page 3 of 5 8. This Agreement shall become effective on the date upon which it is fully executed by all parties. 9. The Provider, for itself and any controlling interests, parent corporations, subsidiary corporations, successors, transferees, and any related entities, discharges the State of Florida, Agency for Health Care Administration, and its agents, representatives, and attorneys of and from all claims, demands, actions, causes of action, suits, damages, losses, and expenses, of any and every nature whatsoever, arising out of or in any way related to this matter and the Agency’s actions, including, but not limited to, any claims that were or may be asserted in any federal court, state court or administrative forum, including any claims arising out of this Agreement, by or on behalf of the Provider. 10. This Agreement is binding upon all parties and those identified in the above paragraph of this Agreement. 11. In the event that the Provider was a Medicaid provider at the time of the occurrences alleged in the administrative complaint, this Agreement does not prevent the Agency from seeking Medicaid overpayments related to the subject issues or from imposing any further sanctions pursuant to Rule 59G-9.070, Florida Administrative Code. 12, The undersigned have read and understand this Agreement and have the authority to bind their respective principals to it. The Provider’s representative has the legal capacity to execute the Agreement and has consulted with independent counsel. The Provider understands that counsel for the Agency represents solely the Agency and that counsel for the Agency has not provided any legal advice to, or influenced, the Provider in its decision to enter into the Agreement. 13. This Agreement contains and incorporates the entire understandings of the parties. This Agreement supersedes any prior oral or written agreements between the parties. This Page 4 of 5 Agreement may not be amended or supplemented except in writing. Any attempted assignment of this Agreement shall be void. 14. All parties agree that a facsimile signature suffices for an original signature. The following representatives acknowledge that they are duly authorized to enter into this Agreement. Elizabeth Deputy Se Agency for Health Care Administration Community Healthcare Center of Pensacola 2727 Mahan Drive, Bldg. #1 6770 North Ninth Avenue Tallahassee, Florida 32308 Pensacola, Florida 32504 DATED: Mf 7 2007 DATED: w\ | 04 COoUNAL 0 Grmun Reronice ht or nn : . Andrew T. Lavin, Esquj Office of the General Counsel Navon & Lavin, P.A. Agency for Health Care Administration Emerald Park Office Center 2727 Mahan Drive, Mail Stop #3 2699 Stirling Road, Suite B-100 Fort Lauderdale, Florida 33312 DATED: u/ 19]04 DATED: “4 Thomas M. Hoeler, Senior Attorney Office of the General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florig& 32708 DATED: Page 5 of 5
The Issue The issues are whether Respondent failed to maintain emergency medications, in violation of Florida Administrative Code Rule 59A-9.0225(1), and failed to ensure that a defibrillator was available for immediate use, in violation of Florida Administrative Code Rule 59A-9.0225(2). If so, another issue is the penalty that should be imposed.
Findings Of Fact At all material times, Respondent has operated, under the jurisdiction of Petitioner, a licensed abortion clinic facility, bearing license number 899. The facility in question is located in North Miami Beach. At the time of the surveys described below, Respondent also operated another facility in south Miami, but that facility is not involved in this case. All references to "facility" will therefore refer to the North Miami Beach location. On June 8, 2010, one of Petitioner's surveyors conducted a relicensure survey of Respondent's facility. As is typical of such surveys, this survey was unannounced. During the survey, the surveyor discovered three expired medications in the facility: 0.2 mg Isuprel®--expired August 2009, 0.4 mg atropine--expired February 2010, and an unspecified dosage of nalbuphone--expired February 2010. These expired medications were on a shelf in the operating room. During the survey, the surveyor also discovered that the facility did not have a defibrillator. At the conclusion of the survey, the surveyor conducted an exit conference with the sole employee present at the facility. During this conference, the surveyor explained these deficiencies and gave Respondent until July 8, 2010, to correct them. Subsequently, the surveyor prepared a report showing these violations and confirming that the deadline for correcting both deficiencies was July 8, 2010. On April 21, 2011, the surveyor returned, again unannounced, to the facility to conduct a followup survey and again found only one employee present at the facility. During this survey, the surveyor discovered three expired medications in the facility: one 500-ml IV bag of Lactated Ringer's-- expired April 2009, 1 mg atropine--expired November 2010, and 2% lidocaine hydrochloride injection--expired November 2010. The surveyor found these expired medications in a locked storage box on the crash cart, which is the cart used for medical emergencies. During the followup survey, the surveyor also discovered that the facility did not have a defibrillator. On the dates of both surveys, the facility did not have any surgical procedures scheduled. Also, no patients were present at anytime during either survey. During each survey, the surveyor selected five dates at random to determine if the facility had performed any second- trimester abortions, and she found that no such procedures had been performed on any of these dates. For this reason, the surveyor did not cite the facility for any violations that are contingent on the actual performance of second-trimester abortions--such as, the failure to have a registered nurse in the recovery room. Similarly, because no patient was present during the surveys, the surveyor testified that she did not cite the facility for a failure to maintain anaesthesia equipment in the operating room; the surveyor explained that the anaesthesiologist brings his or her own equipment when attending a surgical procedure. The surveyor explained that she cited Respondent for the deficiencies alleged in this case because they are contingent upon licensure only, not licensure and the actual performance of second-trimester abortions. At the time of each survey, regardless of the level of patient activity, the facility was open and capable of supporting the procedures for which it is licensed. Dr. Rosenthal offered an explanation for each of the deficiencies cited in this case. As he testified, the expired medications found during the followup survey were in a locked storage box maintained by a certified registered nurse anesthetist, who had not worked at the facility for several years, but had never returned to retrieve her storage box. However, Dr. Rosenthal's explanation does not account for why the surveyor missed the Lactated Ringer's IV fluid during the original relicensure survey, if, in fact, she did miss this item. (The other two items were not expired at the time of the earlier survey.) Notwithstanding any shortcoming in Dr. Rosenthal's explanation, more importantly, the record fails to establish the absence of current emergency medications and IV fluids at the facility. As noted below, the cited rule requires that the facility contains these items; as long as it does, the cited rule is not violated by the presence of expired medications and fluids at the facility. The presence of such expired items is insufficient, especially when the standard of proof, as noted below, is clear and convincing evidence, to support an inference that adequate, current medications and IV fluids were not also available at the facility. As Dr. Rosenthal testified, at the time of both surveys, Respondent maintained a single defibrillator, which he transferred from one facility to another, depending on which facility was to be the site of surgical procedures on a given day. This explanation is not responsive to the requirement of a defibrillator at each facility.
Recommendation It is RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of failing to maintain a defibrillator and imposing an administrative fine of $500 for this violation and dismissing the charge pertaining to expired medications and IV fluids. DONE AND ENTERED this 10th day of July, 2012, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 10th day of July, 2012. COPIES FURNISHED: Vlad Van Rosenthal A Medical Office for Women Suite 402 909 Northeast 163rd Street Miami, Florida 33160 Nelson E. Rodney, Esquire Agency for Health Care Administration Suite 300 8333 Northwest 53rd Street Miami, Florida 33166 nelson.rodney@ahca.myflorida.com Richard J. Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Stuart Williams, General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Elizabeth Dudek, Secretary Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 1 Tallahassee, Florida 32308
The Issue Whether Respondent, Doctor's Office for Women, Inc., d/b/a Today's Women Medical Center (Respondent), failed to maintain medical records as alleged in the Administrative Complaint filed with DOAH on March 28, 2012.
Findings Of Fact At all times relevant to this proceeding, Respondent has been licensed as an abortion clinic authorized to perform first and second trimester abortions. The facility at issue in this proceeding is located in Miami-Dade County, Florida. Respondent is required to comply with the following provisions of Florida Administrative Code Rule 59A-9.031: A permanent individual clinical record shall be kept on each clinic patient. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval. Clinical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval. Clinical records involving second trimester abortion procedures shall be kept confidential and secure. Operative reports signed by the physician performing the second trimester abortion shall be recorded in the clinical record immediately following the procedure or that an operative progress note is entered in the clinical record to provide pertinent information. Clinical records shall be kept on file for a minimum of five years from the date of the last entry. At the times relevant to this proceeding, Respondent used a consent form which, preceding the line for the patient to date and sign the form, states as follows: I, , voluntarily authorize Doctor's Office for Women, [Dr. Rosenthal], who is an independent provider and will have complete control over this procedure, follow up and any and all treatments and whomoever he may designate as his assistants, to perform upon me an elective abortion. I fully understand that the purpose of the procedure is to terminate my pregnancy, and I affirm this is to be my personal choice in the light of the alternative of continuing the pregnancy to full term. I further request and authorize him to do whatever he deems advisable if any unforeseen conditions arise in the course of the abortion that call, in his judgment, for procedures in addition to or different from those contemplated. I will fully and completely disclose my medical history, including allergies, blood conditions, prior medications or drugs taken, and reactions I had to anesthesia, medicines of [sic] drugs, I consume to my physician relying on my disclosure to be complete. I consent to the administration of anesthesia as may be deemed necessary or advisable by my physician. I understand that local anesthesia do not eliminate all pain completely and IV sedation anesthesia (Versed, Valium, Demerol) will not put me to sleep and no guarantee to the contrary have been made to me. The nature and purpose of an abortion, the procedures, the risks involved, the emotional distress, and the possibility of complications have been fully explained to me. I realize there are inherent risks of minor and major complications which may occur in this and all surgical procedures without the fault of the physician. No guarantee has been made to me. The complications include, but are not limited to: allergic reaction to the sedative or anesthesia; infection; excessive bleeding; the need for a second D&C to complete the abortion; perforation of the uterus; laceration of the cervix; hysterectomy - surgically removing the pregnancy through the abdomen; removal of the uterus as treatment of a complication (hysterectomy), also, one study indicates the possibility of breast cancer due to abortions even though these studies are not conclusive, we still recommend annual breast examinations, etc. [sic]. I release the doctors and Doctor's Office for Women and any corporation which operates this facility from any liability resulting from the above mentioned [sic] or any other complications. I further realize that I may need to be hospitalized at my own expense for treatment of such complications. I realize that such conditions can be caused by my own condition or conduct. I will accept hospitalization, if required by the doctors for any complications arising from this procedure. I understand that my complication requiring hospitalization, as a result of the termination will not be covered financially by the Doctor's Office for Women, or corporation which may operate this facility or the doctors. I understand that any questions I have will be answered before leaving the facility. If I have any questions or complications after leaving, I agree to call the Doctor's Office at this number: [xxx- xxx-xxxx]. I understand that I must return to the office for a two-week post-termination evaluation (free). I also acknowledge that if I do not return for this evaluation, I have not completed my medical care and release the Doctor's Office for Women and physicians from any liability resulting from my termination. The undersigned hereby expressly waives and releases for themselves, heirs or representatives any claims or demand which they may have of any nature, kind or description against [Dr. Rosenthal] and/or his/her assistant/s and Doctor's Office for Women, and any corporation which operates this facility and the undersigned do [sic] specifically assume any and all responsibility for the operation, acknowledging that the same is done at their [sic] request for their benefits [sic]. I certify that (if married) I have notified my husband of my intention to obtain a termination of pregnancy and I have given him the opportunity to consult with me concerning this decision. I CERTIFY THAT I HAVE READ AND FULLY UNDERSTAND THE ABOVE CONSENT TO AN ABORTION THAT THE EXPLANTAIONS THEREIN REFERRED TO WERE MADE [sic]. I GIVE THIS PERMISSION VOLUNTARILY AND OF MY OWN FREE WILL, I FURTHER REPRESENT AND WARRANT THAT I HAVE FULL LEGAL AUTHORITY TO GIVE THIS PERMISSION. On July 18, 2011, the Patient executed the foregoing consent form, and Dr. Rosenthal performed an abortion on the Patient. On September 20, 2011, Ms. Render inspected the Patient's medical records as maintained by Respondent as part of a survey of the facility. Respondent's records for the Patient reflect the events of July 18, 2011. The Patient's records reflected that the Patient was seen at an emergency room on a date between July 18 and September 13, 2011. The Patient's records did not reflect the date of that visit to the emergency room. The Patient's records reflect that the Patient had gone to the emergency room due to excessive bleeding for a sustained period of time following the abortion on July 18, 2011. The Patient's records reflect that all findings at the emergency room were "WNL" (within normal limits), but the records have no further information as to the emergency room visit. On September 13, 2011, the Patient returned to Respondent's facility, at which time Dr. Rosenthal performed on the Patient a procedure generally referred to as a D&C (dilation and curettage). The Patient did not sign a separate consent form for the second procedure. Ms. Randolph's testimony, and the consent form itself, established that the consent form authorized emergency follow-up care for the abortion, but it was insufficient to authorize the D&C some eight weeks after the abortion. Petitioner established that Respondent should have obtained written consent for the second procedure and should have maintained that consent as part of the Patient's records.1/
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order finding Respondent guilty of failing to maintain a consent form for the second procedure, but dismissing all other charges against A Doctor's Office for Women, Incorporated, d/b/a Today's Women Medical Center. It is further recommended that the final order impose an administrative fine in the amount of $1,000.00 against A Doctor's Office for Women, Incorporated, d/b/a Today's Women Medical Center. DONE AND ENTERED this 31st day of July, 2012, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 2012.
The Issue The issues in this case are whether Respondent, a plastic surgeon, committed medical malpractice in connection with a breast augmentation procedure; and if so, whether Petitioner should impose discipline on Respondent's medical license within the applicable penalty guidelines or take some other action. RELIMINARY STATEMENT In or around November 2006, Petitioner Department of Health issued a two-count Administrative Complaint against Respondent Roger L. Gordon, M.D. The Department alleged that Dr. Gordon had committed medical malpractice in connection with a breast augmentation procedure performed on patient "D.V.", and that he had failed to maintain medical records justifying the course of D.V.'s treatment. Dr. Gordon denied the charges and timely requested a formal hearing. The Department referred the matter to the Division of Administrative Hearings ("DOAH"), where it proceeded as Case No. 07-0644PL. DOAH's file in Case No. 07- 0644PL was closed on April 30, 2007, on the Department's Motion to Relinquish Jurisdiction, in which the parties reported that they had reached an agreement to settle the dispute. On March 30, 2011, under a Motion to Re-Open Case, the Department referred the matter back to DOAH following the Board of Medicine's rejection of the agreement between the Department and Dr. Gordon. The undersigned was assigned to preside in the matter, which was placed on the docket as Case No. 11-1600PL. The final hearing took place as scheduled on August 24, 2011. Both parties were represented by counsel. At the outset, the undersigned granted both (a) the Department's uncontested motion to take official recognition of the pertinent disciplinary guidelines and (b) the Department's Motion to Amend Administrative Complaint, which Dr. Gordon opposed. In accordance with the latter ruling, the Department's Amended Administrative Complaint was deemed filed as of August 17, 2011. Also as a preliminary matter, the Department urged the undersigned to admit into evidence the medical records relating to D.V.'s treatment at the Florida Center for Cosmetic Surgery1 (the "FCCS records"), on two principal grounds. First, the Department argued, on the authority of Sheppard v. Florida State Board of Dentistry, 369 So. 2d 629, 631 (Fla. 1st DCA 1979), that because the FCCS records are of the sort required by law to be kept and made available for inspection by regulatory authorities, they therefore are not protected by the Fifth Amendment in a penal proceeding such as this. This argument was rejected, in short because Dr. Gordon did not invoke his right to remain silent as the basis for excluding the FCCS records; he objected to them on the basis of the hearsay rule. Second, the Department contended that because Dr. Gordon failed to invoke the Fifth Amendment as a basis to quash the subpoena by which the Department obtained the FCCS records, he waived the privilege against self-incrimination and therefore should be compelled to give testimony regarding the facts necessary to establish the business-records exception. The undersigned rejected this argument because the Department was unable to cite any law in support of the proposition that Dr. Gordon's failure to seek invalidation of the subpoena necessarily resulted in the evisceration of his right to remain silent at the final hearing. The proposition is unsupportable in any event because the subpoena was not addressed to Dr. Gordon personally but rather commanded the records custodian of the South Florida Center for Cosmetic Surgery to produce the medical records at issue. See Respondent's Motion in Limine to Exclude Records (filed July 14, 2011), Exhibit A. Dr. Gordon himself, in his individual capacity, did not have "standing to assert the fifth amendment right on a subpoena which was not addressed to him personally." State v. Wellington Precious Metals, Inc., 510 So. 2d 902, 905-06 (Fla. 1987). That being the case, Dr. Gordon did not waive his right against self- incrimination by declining to object to the subpoena, which would have been a futile act given his lack of standing to do so.2 The Department's witnesses were Donna Howell, an employee of the Department; and Cynthia Lee Toot, an advanced registered nurse practitioner. The Department's Exhibit A (a composite exhibit comprising D.V.'s medical records from Holy Cross Hospital in Fort Lauderdale) was admitted into evidence at hearing, and the record was held open to allow the Department to submit the deposition of D.V., which was subsequently received and is hereby admitted. Dr. Gordon did not present a case. On September 8, 2011, the Department filed a Motion to Relinquish Jurisdiction. As a result of that motion, the undersigned ruled that jurisdiction over the Amended Administrative Complaint (but not the pending Motion for Attorney Fees3) would be relinquished without delay or additional input from the parties; proposed recommended orders thus were unnecessary.
Findings Of Fact At all times relevant to this case, Respondent Roger L. Gordon, M.D., was licensed to practice medicine in the state of Florida, having been issued license number ME 82538. Dr. Gordon is certified in Plastic Surgery by the American Board of Plastic Surgery. Petitioner Department of Health (the "Department") has regulatory jurisdiction over licensed physicians such as Dr. Gordon. On November 24, 2004, D.V. appeared as scheduled at the South Florida Center for Cosmetic Surgery for an augmentation mammoplasty and full pattern mastopexy. According to her medical records, D.V. tolerated the procedures well, and was discharged home at around 11:45 a.m. Later that day, D.V. returned to the South Florida Center for Cosmetic Surgery with complaints of pain and swelling of the right breast. Dr. Gordon diagnosed hematoma (accumulation of blood) of the right breast. He noted that the condition required evacuation and placement of a drain. Because D.V. had eaten after her original discharge, the evacuation procedure was performed under local anesthetic. Dr. Gordon warned D.V. that a more extensive exploration surgery under general anesthesia might be required in the future. He did not obtain an anesthesia consult prior to evacuating the hematoma. Dr. Gordon did not identify any active bleeding during the evacuation procedure. D.V. was again discharged home after the hematoma had been evacuated. D.V. reported that, after returning home, she experienced two episodes of fainting. The records of Holy Cross Hospital reflect that D.V. was admitted to the emergency room following the fainting spells. Upon admission, D.V.'s hemacrit was 22.5, indicating significant anemia. Two units of blood were administered to D.V. in anticipation of a re-exploration of the right breast under general anesthetic. On or about November 25, 2004, at Holy Cross Hospital, D.V. underwent surgical exploration of the right breast and removal of the right breast implant. She tolerated the procedures well and was discharged with instructions to follow up with Dr. Gordon on November 26, 2004. D.V. had no further complications and returned for right breast re-augmentation on or about January 21, 2005, with no known complications.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order finding Dr. Gordon not guilty of the charges set forth in the Amended Administrative Complaint. DONE AND ENTERED this 20th day of September, 2011, in Tallahassee, Leon County, Florida. S JOHN G. VAN LANINGHAM 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 20th day of September, 2011.
