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 The administrative fine against the Respondent in AHCA Case No. 2009001632 is withdrawn. 3.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 The initial application seeking laboratory licensure in Case No. 2009007700 is withdrawn. 5.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
Findings Of Fact At all times relevant hereto, Respondent was licensed as a medical doctor by the Florida Board of Medicine. He holds License No. ME 0019700. Respondent received his medical degree overseas and did his residence in obstetrics and gynecology at Bayfront Medical Center in St. Petersburg, Florida. He is neither board certified nor board eligible. For the past eight plus years Respondent's practice has been limited to terminating pregnancies at All Women's Health Clinic at Tampa, Florida. He has performed in excess of 15,000 abortions. One reason given by Respondent for so limiting his practice is the cost of medical malpractice insurance. Since he has no private practice, Respondent gave up admitting privileges at hospitals in the area. Without malpractice insurance, he would not be given staff privileges. On August 23, 1986, A. L., a pregnant 16 year old, entered All Women's Health Center, Tampa, to have her pregnancy terminated. A. L. had noted on her history statement that her last menstrual period started some eight weeks ago. Respondent first saw A. L. when he entered the procedures room at All Women's Health Center and commenced his examination prior to instituting abortion procedures. With respect to the examination the testimony varied widely. Diane Roberts, LPN, who was performing the duties of physician's assistant during the procedure, initially told the investigators that the examination lasted only a couple of seconds and consisted of a vaginal examination with two fingers of the right hand in the vagina while the abdomen was palpated with the left hand. At the hearing, Roberts testified that she wasn't paying much attention to the patient during the examination, didn't recall telling investigator the examination only took a couple of seconds, and recalled Respondent telling A. L. several times to relax. Respondent testified he performed a normal vaginal examination. The examination was longer than usual because A. L. wasn't relaxed and tensed her stomach muscles which made the uterus more difficult to palpate; and that following his examination he determined the gestational age of the fetus to be 12 weeks. Respondent testified he also checked the patient's heart and lungs before commencing the pelvic examination. A. L. testified that Respondent palpated her abdomen with two hands, but did not check heart and lungs or do a pelvic examination. A. L. had an earlier pregnancy terminated the previous year when the doctor did a pelvic examination with two fingers in the vagina while the abdomen was palpated with his other hand. The patient was ultimately determined to be 28 to 30 weeks pregnant. Largely because of the large error in gestational age, it is concluded that Respondent performed only a perfunctory examination on A. L. Had he conducted the proper examination, it is inconceivable that he, an experienced gynecologist, could underestimate the gestational age of the fetus by some four months. The magnitude of this error is illustrated by Respondent's testimony that a 12 week fetus is approximately 3 inches long and weighs 30 grams, while a 28 week fetus is approximately 14 inches long and weighs 1100 grams. Respondent started the procedure thinking he was aborting a 12 week fetus with the patient on the table and feet in the stirrups. After the instruments were inserted and the procedure started, Respondent concluded the fetus was 16 weeks, obtained a larger curette, then determined the fetus was more likely 20 weeks, again changed curette, and after removing fluid and part of an arm Respondent concluded that the gestational age of the fetus was some 28 weeks and required hospitalization to complete the procedure. Mistakes in determining gestational age can be made by a prudent physician if: (1) the patient is obese; (2) if the uterus is very soft and the extremities difficult to locate; (3) if the baby has a low fluid volume; (4) if the patient is very tense; or, (5) if the head of the fetus is felt and not the uterus. Here A. L. was more thin than obese which should have greatly facilitated palpation of the abdomen to determine the size of the uterus. Accepting the testimony that she was tense during the examination, and the earlier pregnancy would cause the uterus to be soft, no experienced gynecologist should conduct an examination of a patient such as A. L. and err on the magnitude here involved. Further, if the examination was difficult, the procedure should not have commenced until Respondent was reasonably positive of the gestational age of the fetus. One indication Respondent received that the fetus was older than 12 weeks was the quantity of fluid drawn. Further, no experienced gynecologist should mistake the head of the fetus as the extremity of the uterus on a patient such as A. L. Once Respondent determined the fetus was more than 16 weeks along, he called Dr. Barile, a gynecologist with admitting privileges at Humana Women's Hospital, Tampa, to request he remain available in case Respondent needed to send A. L. to a hospital. When Respondent determined the gestational age of the fetus' was more than 26 weeks, he again called Barile who suggested it would be better to refer the patient to an obstetrician. Respondent then telephoned his backup obstetrician and found she was on vacation, and a doctor with whom Respondent was not acquainted was taking her calls. Since A. L. was stable and in no apparent distress, Respondent called Dr. Klein, a pediatrician with admitting privileges at Bayfront Memorial Hospital in St. Petersburg. Dr. Klein agreed to take care of the patient by having his associate, who had the duty that day, meet the patient at Bayfront. A. L. had been brought to the clinic by her brother, and Respondent concluded A. L. could be safely transported to Bayfront by automobile and suggested her brother drive her. The brother demurred on the ground that his car overheated and might not make the 40-odd mile trip to Bayfront safely, but another brother had a more reliable car. The other brother was called and agreed to take his sister to Bayfront and stated that he would be at the clinic in about 10 minutes. Approximately 1 hour and 15 minutes later this brother arrived, and A. L. was started to the brother's car. At this time she appeared unsteady, and Respondent concluded she should go to Bayfront by ambulance. When a Hillsborough ambulance service was called, they told Respondent of the policy whereby they could not transport a patient out of Hillsborough County and that he should contact a Pinellas County ambulance service to perform the desired transportation. Respondent then called a Pinellas County ambulance service who arrived about an hour later to take A. L. to Bayfront where she was met by Dr. Yeshnick, the associate of Dr. Klein, who admitted the patient. Between the time Respondent determined the abortion could not be performed at the clinic until A. L.'s arrival at Bayfront Hospital, some 6 hours had elapsed. Of the approximately 15,000 abortions that Respondent has performed, less than 5 became emergencies that required removal from the clinic to a hospital. Respondent's backup procedures for emergencies were adequate. On August 23, 1986, A. L. was in the third trimester of her pregnancy, and the abortion was not necessary to save the life or preserve the health of A. L.
The Issue Whether disciplinary action should be taken against the respondent, Tana Lee Hand, for an attempt to procure a license to practice nursing in the State of Florida by giving a false answer on an application form.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law the Hearing Officer recommends that the Administrative Complaint against tile respondent, Tana Lee Hand, be dismissed. DONE and ORDERED this 14th day of July, 1980, in Tallahassee, Leon County, Florida. DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Jeffery B. Morris, Esquire 2400 Independent Square One Independent Drive Jacksonville, Florida 32202 Robert J. Castellanos, Esquire 1528 Hendry Street Post Office Box 1999 Fort Myers, Florida 33902 Geraldine B. Johnson, R. N. Board of Nursing 111 Coastline Drive East, Suite 504 Jacksonville, Florida 32202
The Issue The issues presented for decision herein are whether or not the Respondent's physician license number ME 0034228 should be disciplined based on allegations set forth hereinafter in detail, that he violated various provisions of Section 458.331, Florida Statutes, as set forth in the consolidated administrative complaints filed under DOAH Case Numbers 83-1819 and 84-3052, as amended.
Findings Of Fact Based on my observation of the witnesses and their demeanor while testifying, documentary evidence received and the entire record compiled herein, I hereby make the following relevant factual findings. Respondent is a licensed physician and has been issued license number ME 0034228 in the State of Florida. Between December 31, 1981, and at least December 1982, Respondent's license to practice medicine was placed on inactive status because of nonpayment of licensing fees. (Petitioner's Exhibit 10 and TR page 31) During the above-referenced time periods, Respondent performed or aided in the performance of medical abortions in Miami, Florida, including ones relating to Janet Lee Miller, Myrtha Baptiste, and Yvonne Bruno. (TR pages 326- 347 and 350- 377) On dates that Respondent performed or assisted in the performance of medical abortions previously mentioned, Respondent did not have an active license to practice medicine in the State of Florida. Myrtha Baptiste died following an abortion. In conjunction with criminal investigations of the death of Myrtha Bactiste, Respondent was interviewed by Nelson Andreu, a homicide detective with the City of Miami Police Department and George Sanchez, who was then an investigator with the State Attorney's Office. During the course of those interviews, Respondent advised Andreu and Sanchez that he had personally mailed in the items required for renewal of his license and that, as far as he knew, his license was valid. Megaly Lorenzo, a secretary in the Santa Rosa Medical Center where Respondent worked in 1981 and 1982, testified that Respondent gave Lorenzo his renewal fees in cash for 1982. Lorenzo did not renew Respondent's license because she forgot to. She informed Respondent of that omission during 1983. (TR pages 309-312) When Megaly Lorenzo renewed a license, she received a wallet-sized license from the Board of Medical Examiners which was then placed in the mirror in the offices at the Santa Rosa Medical Center. Between approximately January 15, 1981 and December 1982, Respondent worked as a physician at the Women's Care Center located at 5601 Biscayne Boulevard, Miami, Florida. At times material hereto, Hipolito Barreiro was the owner and director of Women's Care Center. At all times material hereto, Hipolito Barreiro was not licensed to practice medicine in the State of Florida. (Petitioner's Exhibit 3 and testimony of Elaine Prater, TR page 268) Between approximately January 15, 1981, and December 1982, Barreiro was engaged in the practice of medicine at the Women's Care Center located at 5601 Biscayne Boulevard, Miami, Florida. During the relevant time period, Hipolito Barreiro performed various procedures which constitute the practice of medicine. As example, during February 1982, Barreiro inserted an intrauterine contraceptive device into Carmen Moses' cervix. In July 1982, Barreiro gave Patricia Humbert an injection and later performed an abortion on Humbert. In September 1982, Barreiro performed a gynecological examination on Etta Annette Brown to determine the status of her pregnancy. In December, 1982, Respondent performed a vaginal examination on Debra Plez confirming the fact that Plez was 6 1/2 months pregnant. Barreiro gave Plez a prescription, placed an IV in Plez's arm and finally performed an abortion on her (Plez). Elaine Prater, an employee at the Women's Care Center, observed Barreiro perform abortions on several occasions while Respondent was employed as a physician at the Women's Care Center. Respondent would sign patient charts as the physician performing the abortion when, in fact, the abortion was performed by Barreiro. These occurrences would usually take place in those instances where Respondent either arrived at work late or left work early. Additionally, it was noted that Respondent maintained a separate list of those patients on whom he performed an abortion and those patients for whom he had not operated or aborted. Ms. Prater acknowledged that Respondent was confronted on several occasions by her (Prater) and Trudy Ellis about his practice of signing charts for those patients whose abortions he had not performed. Finally, Respondent admitted to Roger Stefins that he knew that Barreiro was not licensed to practice medicine in Florida. Also, evidence reveals that Respondent confronted Barreiro on more than one occasion asking, "Haven't I told you not to examine girls before?" (TR page 80) As stated, Respondent maintained a separate list of patients on whom he had performed abortions for his own use. (See Petitioner's Exhibits 3 and 4) On several occasions, Respondent was presented "physician's reports of the termination," for abortions performed by Barreiro and was asked to sign the reports as a "physician" performing the termination. Respondent signed these reports even though he knew that the actual abortions had been performed by Barreiro. (TR pages 269-275) Respondent knew, or should have known, that the abortions had been performed by Barreiro as he was on duty, and because the patients would already be in the recovery room when he (Respondent) arrived for work. (TR page 278) During May 1982, Yvonne Bruno, a twenty-eight year old Haitian woman, went to the Women's Care Center for the purpose of having an abortion performed. Initially, Bruno went to the Women's Care Center on May 4, 1982, with $160. She was told to come back to the Center on the following Saturday, May 8, 1982, with $200. Bruno was not examined during that initial visit. On May 8, 1982, Ms. Bruno returned for the purpose of having an abortion. She only had $190. After arriving at the clinic, Bruno changed into a paper gown. Bruno signed several papers on May 8, 1982. One such paper was a sheet entitled, "Important Information Which Every Patient Should Know Concerning The Termination Of Pregnancy Procedure," which was a form maintained by the Women's Care Center. On the information sheet, Bruno's last menstrual period was listed as January 23, 1982. The appointment date for Bruno's abortion was listed on the information sheet as "5-9-82." In addition to the information sheet, Bruno also signed a form giving her consent for the Respondent to perform a pelvic examination. The consent form bore the date "5-8-82." Finally, Bruno signed a "Patient Information And Medical History" form which was dated May 9, 1982. (Petitioner's Exhibit 8) On May 8, 1982, Respondent performed an abortion on Bruno, using the dilation and aspiration method, followed by curretage. During the course of the abortion, Bruno's uterus was perforated. Respondent knew that Bruno's uterus was perforated almost immediately following perforation. (Petitioner's Exhibits 3, 4, 8, 9 and testimony of Pedro Ramos) On the physician's report of the termination, the term of Yvonne Bruno's pregnancy was listed as twelve (12) weeks. The form indicated that the termination was performed on May 9, 1982. Examination of the facts reveal that this was incorrect. The physician's report of the termination for Bruno indicated that the following complications occurred: "Complications: After aspirations with vacuum, the use of curette reveals perforation of uterus. We stop the operation and the patient is taken to the hospital." The physician's report of the termination for Bruno was signed by Respondent. (Petitioner's Exhibit 8) Ms. Bruno awoke after the abortion and was put in the recovery room. She was cold and experienced stomach pain more severe than she ever experienced before. The pain was persistent. Bruno informed the doctor who performed the abortion that she was having pains while she was still in the recovery room at the Women's Care Center. (TR pages 360-362) While Bruno was in the recovery room, the doctor who performed the abortion told Bruno that she has something in her uterus and that he (the doctor) had cleaned it out. He told Bruno that if she felt any more pain to call him, regardless of time. He also gave Bruno the telephone numbers for his house and the clinic. (TR pages 361, 362) Ms. Bruno remained at the Women's Care Center in the recovery room only long enough for a taxi to arrive. Immediately upon being taken to the recovery room, her friend, Amelia Ingrid Previle, called for a taxi. Bruno was in the recovery room less than an hour. While in the recovery room, Ms. Bruno's condition was not monitored. That is, no one took her blood pressure, respiration or pulse rates. (TR pages 363, 364 and 367-370) When the taxi arrived, Ms. Bruno left the Women's Care Center unable to walk because "her feet were so heavy." Therefore, the taxi driver and her friend, Previle, had to help Bruno to her friend's car. (TR pages 362, 363) It took Ms. Bruno approximately 15 minutes to get home from the Women's Care Center. When she arrived home, she felt intense pain which she credited to the fact that perhaps she had not eaten before she went to the Center. She drank tea and put some ice on her stomach. Bruno's pain intensified and her friend, Previle, started trying to contact Respondent in the late afternoon on May 8, 1982, by phone. Previle continued to try to contact the doctor until the early morning on May 9, 1982. When Previle finally contacted the doctor, Bruno was directed to come to the Women's Care Center. Bruno did so and, upon arrival at the Women's Care Center, she was given a pill. She was then taken to American Hospital in Miami, Florida. At approximately 6:30 a.m. on May 9, 1982, Hipolito Barreiro contacted Pedro M. Ramos, a physician specializing in gynecology and informed him that he had an abortion clinic. Barreiro also told Ramos that "they" thought that "they" had perforated a uterus during an abortion. Dr. Ramos agreed to meet the patient at the emergency room of American Hospital. (TR pages 326, 327) Once Dr. Ramos arrived at American Hospital, he attempted to obtain a patient history from Bruno; however, this was difficult because of Bruno's limited ability to speak English. With the help of Barreiro and Previle, Dr. Ramos was able to obtain some information. However, on the patient history, Dr. Ramos made the notation that "unable to verify (past illness) properly. Pt. speaks little english." (TR pages 329, 350-377 and Petitioner's Exhibit 9) When Dr. Ramos arrived at American Hospital, he was given the following patient history for Bruno: "25-year old black female complaining of abdominal pain of 4-6 hours onset with fever (? chills) with brownish discharge from vagina after an abortion performed on May, 1983 . . ." (Testimony of Pedro Ramos, M.D. and Petitioner's Exhibit 9) Based on the available information, Dr. Ramos diagnosed Bruno as suffering from a perforated uterus and possibly peritonitis. After performing the necessary laboratory tests, Bruno was taken to surgery for an exploratory laparotomy which revealed a perforated uterus. The uterus was perforated at the fundus on the right side. The perforation was more than 4 centimeters long. The exploratory laparotomy also revealed fetal parts in Bruno's abdomen. Dr. Ramos found at least the head and spine remaining in Bruno's abdomen. (TR page 329 and Petitioner's Exhibit 9) After the exploratory laparotomy, Dr. Ramos also determined that, in addition to the items noted above, an inflammation process had begun (peritonitis), affecting Bruno's ovaries. Dr. Ramos removed the fetal parts from Bruno's body, irrigated the area and performed a complete hysterectomy, removing both the ovaries and uterus which were beyond repair. The head of the fetus removed from Bruno's uterus measured four centimeters by two centimeters. Therefore, Dr. Ramos opined that the fetus would have been approximately 17 to 18 weeks of age. At this stage of development, fetal parts are very hard. When suction is applied to the uterus, the solid parts are moved around. The fetal parts are, at this stage, too large to go through the suction tube and remain in the uterus after suction. Following the use of suction, curretage follows. The manipulation of the curette in the uterus will then result in movement of the fetal parts. Usually, it is the spine or an arm which actually causes the perforation. By manipulating the fetal parts, the physician can cause the fetal part to perforate the uterine wall which is very soft at this stage. Bleeding can be ascertained through a monitoring of the patient's vital signs and by observation of the patient's general appearance. (TR page 224) In determining how long a patient should be monitored after an abortion has been performed, it is important to know the stage of pregnancy. With an early pregnancy, i.e., 10 - 12 weeks, the patient may be observed for a shorter period of time. Where there are no complications, the patient should be observed for between 1/2 to 1 hour. (TR pages 222 - 225) With an advanced pregnancy, i.e., one in the second trimester, the patient should be monitored for two hours after the abortion is completed. The patient might be monitored for a longer period of time if there are difficulties after the abortion is completed. Monitoring should include checking vital signs such as blood pressure, pulse and respiration rates and checking the patient for hemorrhaging and infection. Usually, with a perforated uterus, the patient experiences abdominal pain immediately following the abortion. A doctor who recognizes that he has perforated a uterus during an abortion should transfer the patient to the hospital for observation. If a patient complains of severe abdominal pain immediately upon completion of an abortion, the doctor should observe the patient until the pain disappears or until the cause of the pain is determined and dealt with. In this regard, Respondent admitted that he perforated Bruno's uterus during the performance of an abortion. (Petitioner's Exhibit 3, pages 20-23) Noteworthy is the fact that Respondent, when questioned by Investigator Stefins, an Assistant State Attorney, stated that punctures of the uterine wall should never be treated in the clinic and that on the occasions when he punctured a uterus, he would take that patient to the hospital. Perforation of a uterus is not, in and of itself, malpractice or negligence. It is below minimal standards of care, skill and treatment for a reasonably prudent physician to fail to carefully monitor a patient, by checking blood pressure, pulse and respiration rates, as well as checking the patient's general appearance after an abortion performed during the second trimester, for a sufficient period of time to determine the existence of complications. If the patient complains of persistent abdominal pain, it is below minimally acceptable standards of care, skill and treatment, as recognized by reasonably similar prudent physicians, under such conditions as are described above to release the patient without first carefully monitoring the patient until the pain disappears or until cause of the pain can be determined and dealt with. (Testimony of Doctors Ghali and McLeod)
Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby recommended that the Respondent's physician license number ME 0034228 shall be suspended for a period of two years and a civil penalty of $2000 shall be imposed. RECOMMENDED this 12th day of July, 1985, in Tallahassee, Florida. JAMES E. BRADWELL Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of July, 1985.
Findings Of Fact The following facts were stipulated by the parties and required no proof at hearing: Petitioner, University Hospital, Ltd., is a Florida limited partnership and is the licensee of University Hospital and University Pavilion Hospital, both located on North University Drive, Tamarac, Florida. Petitioner Sebastian Hospital, Inc., is a Florida corporation, and is the licensee of Sebastian Hospital and SandyPines Hospital. Both hospitals are located on separate premises. Petitioner Haines City HMA, Inc., is a Florida corporation, and is the licensee of Heart of Florida Hospital, Inc. and Palmview Hospital. Both hospitals are located on separate premises. Petitioners timely filed their respective Petitions to determine the invalidity of the proposed rules at issue. Petitioners would be regulated by the proposed rules and are substantially affected parties with standing to challenge the proposed rules at issue. No proof is necessary to prove the standing of these Petitioners. Prior Rule 59C-1.004(2)(i) (the "License Consolidation Rule") required CON application and approval for license consolidations pursuant to Section 395.003, F.S. It was declared invalid in University Hospital, Ltd., et al. v. AHCA, 16 F.A.L.R. 3312 (final order dated July 22, 1994). [This decision is referenced throughout as University Hospital.] Prior to invalidation of the License Consolidation Rule, six CON applicants sought issuance of a single, or consolidated, license to replace former separate licenses held by the same licensee for facilities located on separate premises. Each of these six prior applicants involved a general acute care hospital and a specialty psychiatric hospital. Those applicants resulted in an issuance of CON numbers 7303, 6954, 7712, 7311, 7167, and 7047. Each of those six applications was ulti- mately approved in the form of a single license. When the single licenses were issued, no restrictions were placed on the licensees regarding eligibility for Medicaid reimbursement. As reflected in the respective SAARS, a significant result of approval of each of these applications was that the formerly separately licensed psychiatric hospital became eligible for Medicaid reimbursement for treatment of Medicaid patients. All of these prior applicants had licenses issued and became eligible for Medicaid. Such Medicaid reimbursement was not available to the separately licensed psychiatric facilities prior to issuance of a single, or consolidated, license. Aside from the rules under challenge, there has been no change in pertinent state statutes or rules subsequent to the final order in University Hospital Ltd., v. AHCA 16 F.A.L.R. 3312. After invalidation of the Consolidated License Rule, AHCA's interpretation is that issuance of a single, or consolidated, license for a general acute care hospital and a psychiatric hospital does not result in Medicaid eligibility. Petitioners did not participate in any of the rule workshops conducted on June 22, July 7, and November 2, 1994 or the public hearing held on February 13, 1995. Petitioners did not send in any written comments, questions, or materials, or request an economic impact statement. A holding of the Final Order in University Hospital, was that a Certificate of Need was not required prior to the issuance of a single consol- idated license for multiple premises. University Hospital, 16 F.A.L.R. at 3321. The Agency has no discretion regarding rule- making pursuant to Section 120.535. (Joint Prehearing Stipulation, filed 3/14/95) Approximately eighteen months ago and well before the University Hospital decision, the Agency for Health Care Administration (AHCA) commenced a major rewrite of the hospital license rules that had been promulgated by its predecessor agency, the Department of Health and Rehabilitative Services (HRS). After a series of public workshops, the revisions were noticed in the January 20, 1995, Florida Administrative Weekly. These substantial revisions of rule chapter 59A-3 comprise about fifty pages of the Florida Administrative Weekly. The challenged portions comprise only several paragraphs of the revisions. The challenged portions of the proposed rules are: 59A-3.203 Licensure Procedure. (2) All persons requesting licensure for the operation of a hospital under the provisions of Chapter 395, F.S., shall make application to the Agency, on forms provided, AHCA Form 3130- 8003-January 1995, and AHCA Form 3130-8001-January 1995, and shall receive a regular or provisional license prior to the acceptance of patients for care or treatment. * * * (e) An application for the addition of beds or off-site outpatient facilities to a hospital's license must include: A valid certificate of need or letter of exemption as required by ss. 488.041 - 408.045, F.S., and Approval from the Agency's Office of Plans and Construction. * * * (i) A single license will be issued to a licensee for facilities located on separate premises, upon request of the applicant. The license will specifically state the location of the facilities, their services, and the licensed beds available on each separate premises. Such a license shall also specifically identify the general or specialty classification of hospitals located on separate premises. (6) Each license shall specifically state the name of the licensed operator of the hospital, the class of hospital, and the name and location of the hospital. Any beds in the hospital which are regulated under the certificate of need program, as specified in Chapter 59C-1, F.A.C., shall be listed, including the number of licensed beds by type. The license for hospitals having facilities on more than one premises shall specifically state the location of each facility, their general or specialty classification, their services, and the licensed beds available on each separate premises. * * * Specific Authority 395.003, 395.004, 455.239, F.S. Law Implemented, 395.001, 395.003, 395.004, 395.1005, 408.035, 408.036, 455.239, F.S. History New. (emphasis added) Prior to the decision in the University Hospital case in July 1994, the proposed revisions did not include the requirement that the license for facilities on separate premises identify separately the general or specialty classification of each. That provision was added by the agency because it concluded that when it could no longer require a CON for "consolidated" licenses, then general acute care beds and free-standing psychiatric beds could not be "consolidated" on a single license. It is uncontroverted that the substantial effect of the requirement that each facility retain its prior classification is that a facility classified as a class III (specialty) facility is not eligible for Medicaid reimbursement. The agency agrees that proposed rule is based on, and is compelled by section 395.003(2)(d), F.S., which provides as follows: (d) The Agency shall, at the request of a licensee, issue a single license to a licensee for facilities located on separate premises. Such a license shall specifically state the location of the facilities, the services, and the licensed beds available on each separate premises. If a licensee requests a single license, the licensee shall designate which facility or office is responsible for receipt of information, payment of fees, service of process, and all other activities necessary for the Agency to carry out the provision of this part. (Emphasis supplied). It is immediately obvious from a comparison of the text of the proposed rule and the text of the law implemented that the law does not require that the license state the general or specialty classification for the separate facilities. This distinction was not lost on the agency since it included in its legislative package for the 1995 legislative session a proposed amendment to section 395.003(2)(d), F.S. that would cure the inconsistency by adding the proposed rule language to the statute. (Petitioner's exhibit number 16, p. 25) There is a statute which restricts Medicaid reimbursement for treatment in free-standing psychiatric hospitals. The agency argues that the proposed rules give effect to that statute, section 409.905(5), F.S., which provides, in pertinent part: . . . A licensed hospital maintained primarily for the care and treatment of patients having mental disorders or mental diseases is not eligible to participate in the hospital inpatient portion of the Medicaid program except as provided in federal law. . . . (emphasis supplied). Reliance on Section 409.905(5) is misplaced, however, because it is nowhere cited in the proposed rules as authority or law implemented. Moreover, evidence presented at hearing describes federal policy that when two hospitals are consolidated under one license and have a total capacity that is less than 50 percent psychiatric in nature, the premises are both eligible for Medicaid reimbursement, even though one remains primarily for the treatment of mental disorders. (Petitioners' exhibits number 20-22) The federal policy on Medicaid reimbursement was in effect in 1993, prior to the University Hospital decision and prior to the current version of the proposed rules. Section 409.905(5), F.S. has been in effect since 1991, before the six consolidated licenses referenced in paragraph 1, above, were issued. Section 395.003(2)(d), F.S. has been in effect in its current form at all times material. Nothing in the law has changed to support the agency's contention that, after the University Hospital decision, it can no longer issue a single license with a single license classification for separate premises. No evidence nor specific argument was presented with regard to the alleged invalidity of proposed rule 59A-3.203(2)(e), which on its face relates to the addition of beds or an outpatient facility to a hospital's license. Issues related to that portion of the proposed rule are not the issues invoked in this proceeding with regard to Petitioner's facilities. (See Petitioners' exhibit 26, p. 71, deposition of Tanya Williams)
The Issue The issues in this case are whether Respondent violated Subsections 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t), Florida Statutes (2005),1 and Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2004), and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state agency in Florida charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to the Amended Administrative Complaint, Dr. Pendergraft has been a licensed physician in the State of Florida, having been issued license No. ME 59702. Dr. Pendergraft is board-certified in Obstetrics and Gynecology. He does not have hospital privileges in Florida. At all times material to the Amended Administrative Complaint, Dr. Pendergraft, alone or with one or more partners, owned and operated Orlando Women’s Center, Inc. (OWC), a clinic located in Orlando specializing in abortions. OWC is not a hospital. At all times relevant to the Amended Administrative Complaint, Dr. Pendergraft did not have a current, valid Drug Enforcement Administration (DEA) number. On June 3, 2005, R.W. presented to her primary care physician symptoms of weight gain, fatigue, and lack of a menstrual period for several months. R.W. was a marathon runner and had experienced a delay in her menstrual cycle before because of her strenuous training. She had been taking oral contraceptives. At that time, her primary care physician did not diagnose R.W. as being pregnant. A couple of weeks after her visit with her primary care physician, R.W. still had not regained her menstrual cycle and took a home pregnancy test. The results of the home pregnancy test were positive. R.W. contacted her primary care physician, who ordered laboratory tests for R.W. Laboratory tests were conducted on June 14, 2005, and June 21, 2005. Both tests confirmed the pregnancy. R.W. was referred to Bert Fish Medical Center for an ultrasound on June 21, 2005. The ultrasound showed that R.W. was pregnant. The physician who prepared the diagnostic imaging report based on the ultrasound stated in the report: There is a single intrauterine fetus with an estimated gestational age of 24.5 weeks. Positive fetal heartbeat is present at 142 beats per minute. However, there is severe oligohydiamnios with no positive fetal movement. Gestational age is usually calculated from the first day of the last menstrual period (LMP) of the pregnant woman. On average, the last menstrual cycle occurs two weeks prior to conception. Thus, the gestational age that is determined by the LMP is actually two weeks more than the date of conception.2 When the LMP is unknown, fetal measurements are used to calculate the gestational age. Oligohydramnios means a lack of amniotic fluid. Amniotic fluid is basically the fetus’ urine. A lack of amniotic fluid can be caused by the lack of kidneys or obstructed kidneys, rupture of the membranes, or a malfunction of the placenta. The lack of amniotic fluid makes it difficult to assess the fetal measurements using ultrasound. R.W. was referred to an obstetrician, Dr. P.C., who admitted R.W. to Halifax Medical Center for routine laboratory work and an obstetrical ultrasound. The ultrasound was performed on June 22, 2005, and showed that the fetus was in a breech presentation, there was markedly decreased amniotic fluid, the bowel was abnormal, and the ventral wall was suspicious. Based on the ultrasound, it appeared there was gastroschisis or omphalocele. Gastroschisis occurs when the abdominal wall of the fetus does not close properly and the intestines are outside the body. Omphalocele is a herniation of the intestines, and a sac-like structure covers the intestines outside the abdominal wall. The assigned gestational age estimated by the physician reviewing the ultrasound was 25 weeks and five days.3 R.W. was referred to a perinatologist in Jacksonville. Another ultrasound was performed on June 23, 2005. The assigned gestational age was 25 weeks and six days, which would mean that the age of the fetus was 23 weeks and six days from conception.4 The lack of amniotic fluid and the position of the fetus made it difficult to determine the actual gestational age of the fetus. The perinatologist reported the following to Dr. P.C.: At this time, an ultrasound examination was performed which showed a single living fetus in breech presentation. There is no amniotic fluid which precluded an adequate examination of fetal anatomy. The right kidney and bladder were visualized essentially excluding diagnosis of renal agenesis. A normal appearing 4 chamber structure was seen which visually appears to occupy more than 50% of the chest cavity. This is also very difficult to evaluate due to the position of the baby. There appears to be an anterior abdominal wall defect most likely a gastroschisis, however, again this is impossible to evaluate in great detail. Of importance and further complicating the problems in this case, is the biometry. Measurements of head circumference and cerebellum are consistent with 30 weeks, however, the femur length is consistent with 25 weeks. The fact that this patient has been amenorrheic since October when she could be up to 34 weeks gestation is significant. We don’t know the exact gestation but it is of concern that there is a dramatic difference between the extremities, abdomen, and head circumference as well as the cerebellum. This points to a growth retardation process. Doppler studies of the umbilical circulation were slightly elevated but if there had been placental disfunction I would have expected an absent diastolic component which was not the case. * * * [M]y biggest concern has to do with the anhydramnios and the fact that we don’t know for how long this process has been active. Pulmonary hypoplasia is a strong consideration given the size of the chest and the virtual absence of fluid. Nevertheless, not knowing for how long she has not had fluid is difficult to quote her a risk. The second area of concern is that of the appearance of a structural abnormality. Typically gastroschisis is not associated with a chromosomal anomaly, however, given the discrepancies in biometries and the absence of amniotic fluid, I wonder if this is not a gastroschisis or if it is, part of a more complex situation. The perinatologist conveyed his findings to Dr. P.C., who discussed the situation with R.W. R.W. decided to terminate the pregnancy. The office notes of Dr. P.C. stated, “It was felt by me and my partners that facilitating delivery of this non-viable child was appropriate.” Dr. P.C. called Dr. Pendergraft to discuss the case. Dr. Pendergraft agreed to help, and Dr. P.C. gathered R.W.’s medical records to send to Dr. Pendergraft. On July 7, 2005, R.W. presented to Dr. Pendergraft at OWC. R.W. filled out an information sheet and listed the first day of her last normal period as January 5, 2005.5 R.W. filled out the appropriate consent forms, which a counselor reviewed with her. R.W.’s vital signs were taken and laboratory tests were performed by staff at OWC. Dr. Pendergraft’s notes stated that the sonogram showed severe growth restriction of the fetus. He further indicated that there was a possibility of severe pulmonary hypoplasia and risk of life-threatening sudden health issues or probable fetal, prenatal demise. Dr. Pendergraft wrote in his notes that R.W.’s PMD OB/GYN physician concurred with the maternal health reasons for the termination of the pregnancy. On July 7, 2005,6 at approximately 4:27 p.m., Dr. Pendergraft administered Digoxin into the heart of the fetus to stop the fetal heart beat. Dr. Pendergraft and his medical assistant, S.M., monitored the fetal heart beat using a sonogram until the fetal heart stopped. The procedure was documented on a form used by the OWC entitled “Second Trimester Medical Procedure.” On the form, it is noted that the patient was evaluated on July 7, 2005, and found to be 27 to 28 weeks pregnant, which is 25 to 26 weeks from conception. According to T.S., a medical assistant employed by Dr. Pendergraft, the handwriting which indicates the estimated length of the pregnancy belongs to Dr. Perper, a colleague of Dr. Pendergraft. Both Dr. Perper and Dr. Pendergraft signed the form. After the Digoxin procedure was completed, R.W. was taken to a private room and given Cytotec to induce labor. S.M. continued to administer Cytotec and monitor R.W. until 8:30 p.m., when T.S. relieved S.M. At approximately 12:30 a.m., on July 8, 2005, R.W. developed a fever and the administration of Cytotec was discontinued. T.S. administered Ibuprofen to R.W. to lower the fever. At 1:30 a.m., T.S. noted that R.W. was having some cramping. T.S. wrote the following in the progress notes: “I have a standing order from Dr. Pendergraft for 2 cc Demerol [with] 1 cc Phenergran.” This order was to alleviate the pain from the cramping. At the final hearing, T.S. stated that the note was not totally accurate, because the standing order was from Dr. Perper and not Dr. Pendergraft because Dr. Pendergraft did not have DEA authorization. She attributes the error in her notes to her 20-year working relationship with Dr. Pendergraft and her automatically thinking of Dr. Pendergraft in terms of standing orders. The standing order itself was not submitted into evidence. The evidence is not clear and convincing that Dr. Pendergraft gave the standing order for the Demerol and Phenergran. At 4:30 a.m., the cramping had increased. T.S. gave R.W. an injection of 2 cc of Demerol with 1 cc of Phenergran. At 6:30 a.m., R.W. delivered the fetus and placenta at the same time inside an empty water sack. The products of conception, which included the fetus, membranes, and placenta weighed 800 grams. The weight of the products of conception was recorded on a form used by the OWC, entitled “Clinic Examination of Products of Conception.” The form listed the preoperative estimate of gestational age to be 28 weeks, which would be 26 weeks from conception. Dr. Pendergraft was one of the signatories on the form. Dr. Pendergraft charged R.W. $12,000 for the procedure. Although, both Dr. Pendergraft and his associate Dr. Perper, felt that, preoperatively, the gestational age of the fetus was between 27 and 28 weeks, Dr. Pendergraft did not transfer R.W. to a hospital. Jorge Gomez, M.D., testified as an expert witness on behalf of the Department. Dr. Gomez is board-certified in obstetrics and gynecology and in maternal-fetal medicine. Dr. Gomez opined that on July 7, 2005, the age of the fetus from conception was 27 weeks. His opinion was based on biparietal diameter (BPD), the head circumference, the size of the cerebellum, and the femur length. He discounted the abdominal circumference because the abdominal wall defect would result in a less reliable measurement of the age of the fetus. The abdominal wall defect would cause the measurement to be smaller than would be expected for the age of the fetus. Jay Neil Plotkin, M.D., testified as an expert witness for Dr. Pendergraft. Dr. Plotkin has been a licensed physician for 37 years and is board-certified in obstetrics and gynecology. Dr. Plotkin has not treated patients for four years and has not performed an abortion in six or seven years. It was Dr. Plotkin’s opinion that the abortion occurred during the second trimester rather than the third trimester. His opinion is based on the combined fetal and placental weight at time of delivery. He concluded that the gestational age at the time of delivery was 24 weeks, which would translate to 22 weeks of pregnancy from conception. He used a chart to determine the age based on the weight of the fetus, but he did not know if the chart was based on normal fetuses or included fetuses with abnormalities such as the one at issue. Dr. Pendergraft also called Steven Warsof, M.D., as an expert witness. Dr. Warsof is an obstetrician/gynecologist with a subspecialty in maternal-fetal medicine. He has spent most of his professional career pursuing academic issues in obstetrical ultrasonography. It was his opinion that R.W.’s pregnancy was in the second trimester. He also based his opinion on the weight of the products of conception after delivery. Based on the evidence presented, it is clear and convincing that R.W. was in her third trimester of pregnancy when she had the abortion. The only two doctors who placed the pregnancy in the second trimester based their opinions on the weight of the fetus and placenta at the time of delivery. Because of the complications of R.W.’s pregnancy, it is clear that the fetus had not developed normally and was underweight for its age. There had been a lack of amniotic fluid which is essential to development of the fetus. Based on his office records, it is also clear and convincing that Dr. Pendergraft was under the impression that R.W. was in her third trimester of pregnancy when he performed the abortion. The medical records of Dr. Pendergraft do not contain a written certification from two physicians that within a reasonable degree of medical probability the termination of R.W.’s pregnancy was necessary to save the life or preserve the health of R.W. The evidence established that Dr. Pendergraft wrote in his notes that there was a risk of life-threatening, sudden health issues. Assuming he was referring to the health issues of the pregnant woman, this note could be considered a certification that to a degree of medical probability that the abortion was necessary to preserve the health of R.W. However, there is no written certification from another physician that that was the case, and the note of Dr. Pendergraft that R.W.'s primary care physician concurred with the maternal health reasons for termination of the pregnancy is not a written certification from another physician. The medical records kept by Dr. Pendergraft do not contain a written certification that there is a medical necessity for emergency medical procedures to terminate the pregnancy and that no other physician is available for consultation. No evidence was presented concerning the allegations in Counts IV, V, and VI of the Amended Administrative Complaint.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Dr. Pendergraft guilty of violations of Subsection 456.072(1)(k), 458.331(1)(g), 458.331(1)(m), and 458.331(1)(t)1., Florida Statutes; dismissing Counts IV, V, and VI of the Amended Administrative Complaint; suspending his license for one year followed by three years of probation with indirect monitoring; imposing an administrative fine of $10,000.00; and denying his motion for attorney's fees pursuant to Subsection 120.595(1)(b), Florida Statutes. DONE AND ENTERED this 26th day of October, 2007, 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 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 26th day of October, 2007.
The Issue On April 17, 2015, Respondent, Department of Health, issued a Notice of Agency Action Denial of License Renewal ("First Denial Notice"), notifying Petitioner, Alicia Chilito, M.D., that it had denied her application for renewal of her physician license. Thereafter, on May 19, 2015, Respondent issued an Amended Notice of Agency Action Denial of License Renewal ("Second Denial Notice"), reiterating, and stating alternative grounds for, its denial of Petitioner's physician license. Petitioner timely challenged Respondent's decision and the matter was referred to DOAH to conduct a hearing pursuant to sections 120.569 and 120.57(1). The final hearing initially was scheduled for August 14, 2015, but pursuant to motions, was set for December 16, 2015. On August 14, 2015, Respondent filed a Motion to Relinquish Jurisdiction, contending that there were no disputed issues of material fact to be resolved in a hearing conducted under section 120.57(1). This motion was denied by order issued on September 1, 2015, on the basis that disputed issues of material fact existed regarding whether Petitioner was entitled to renewal of her license by default pursuant to section 120.60(1). On December 11, 2015, Respondent filed Department of Health's Motion in Limine, seeking to limit the scope of the final hearing. A telephonic motion hearing was conducted on December 15, 2015, the day before the final hearing. The undersigned granted the motion and excluded evidence that may be offered at the final hearing to challenge the underlying factual basis on which the Termination Final Order was entered. The final hearing was held on December 16, 2015. Joint Exhibits 1 through 4 were admitted into evidence. Petitioner did not present any witnesses. Petitioner's Exhibits 1 through 10 were tendered but not admitted, and were proffered for inclusion in the record. Respondent presented the testimony of Heidi Nitty. Respondent's Exhibit 1 was admitted into evidence without objection and Respondent's Exhibits 5 and 6 were admitted over objection. Official recognition was taken of the Final Order issued by the Agency for Health Care Administration ("AHCA") in the case of Agency for Health Care Administration v. Alicia Chilito, M.D., Case No. 12-571PH (AHCA November 4, 2013) and the Order Granting Motion to Relinquish Jurisdiction in the case of Agency for Health Care Administration v. Alicia Chilito, M.D., Case No. 12-0859MPI (Fla. DOAH July 12, 2012). The one-volume Transcript was filed on January 8, 2016, and the parties were given until January 19, 2016, to file proposed recommended orders. The parties timely filed proposed recommended orders, which were duly considered in preparing this Recommended Order.
Findings Of Fact Petitioner, Alicia Chilito, M.D., is a physician licensed to practice medicine in Florida pursuant to License No. ME 74131. Respondent, Department of Health, is the state agency charged with regulating the practice of medicine, including licensing physicians pursuant to chapters 456 and 458, Florida Statutes (2015). Petitioner timely filed a Renewal Notice, which constituted her application to renew her physician license.1/ Respondent received Petitioner's Application on January 5, 2015. Respondent did not, within 30 days of receipt of her application, request Petitioner to provide any additional information that it was permitted by law to require, nor did it notify her of any apparent errors or omissions in her application. Accordingly, Petitioner's application was complete on January 5, 2015, by operation of section 120.60(1), for purposes of commencing the 90-day period for Respondent to approve or deny her application.2/ The 90-day period from Respondent's receipt of Petitioner's complete application expired on or about April 6, 2015.3/ Heidi Nitty, a government analyst I with Respondent, was involved in the review of Petitioner's application. Her specific role in the application review process was "reviewing court documents and other orders for possible denial of renewal and also recording [Respondent's] final orders in the national practitioner database." In the course of Nitty's review, she determined that Petitioner previously had been terminated from the Florida Medicaid program. Accordingly, she entered a "do-not-renew modifier" to Petitioner's license application file in Respondent's computer system. On January 20, 2015, Petitioner called Respondent to inquire about the status of her application. She was referred to Ms. Nitty, who was not available to speak to her at that time. Petitioner and Nitty exchanged calls over the course of that day, but did not speak to each other until January 21, 2015, when Petitioner again called, and that time, reached, Nitty. At that point, Nitty verbally informed Petitioner that her application "was being denied" due to having previously been terminated from the Florida Medicaid program. On April 17, 2015——some 102 days after Petitioner filed her complete application——Respondent issued its First Denial Notice, notifying Petitioner that it was denying her application. The First Denial Notice stated that Petitioner's license renewal was being denied pursuant to section 456.0635(2)(e) because she was listed on the United States Department of Health and Human Services Office of Inspector General's List of Excluded Individuals and Entities.4/ On May 19, 2015——some 134 days after Petitioner filed her complete application——Respondent issued its Second Denial Notice, again stating its intent to deny Petitioner's application. However, the Second Denial Notice stated that Petitioner's license renewal was being denied pursuant to section 456.0635(3)(c) because she had been terminated for cause from the Florida Medicaid Program pursuant to section 409.913, Florida Statutes, as reflected in the Termination Final Order issued by AHCA on March 6, 2014. The stated basis for AHCA's March 6, 2014, Termination Final Order was that Petitioner previously had been terminated from the federal Medicare program and the Florida Medicaid program. The Termination Final Order is a final order issued by AHCA, who is not a party to this proceeding. Petitioner disputes the underlying factual basis for AHCA's Termination Final Order and claims that, in any event, she did not receive the notice, issued on January 17, 2014, that AHCA was proposing to terminate her from the Florida Medicaid program; thus, she did not challenge the proposed termination. Although Petitioner has raised these challenges to the Termination Final Order in her Petition for Hearing Involving Disputed Issues of Material Fact filed in this proceeding, the undersigned is not authorized to "reopen" AHCA's Termination Final Order and revisit its factual and legal underpinnings5/ so declined to take evidence on those issues at the final hearing in this proceeding.6/ Petitioner asserts that because Respondent's First Denial Notice and Second Denial Notice both were issued more than 90 days after Respondent received her complete application, she is entitled to licensure by default under section 120.60(1). Respondent counters that the 90-day period for approving or denying Petitioner's license commenced on February 4, 2015, so its First Denial Notice was timely issued. Respondent further asserts that, in any event, Nitty's statement to Petitioner during their January 21, 2015, telephone discussion satisfied the "90-day approval or denial requirement" in section 120.60(1), so that Petitioner is not entitled to issuance of a renewed license by default. It is undisputed that AHCA did not issue the written notices of its decision to deny Petitioner's license renewal until well after April 6, 2015. Therefore, unless Nitty's statement to Petitioner on their January 21, 2015, telephone call constituted Respondent's denial of Petitioner's application within 90 days after its receipt, Petitioner is entitled to issuance of her license by default, pursuant to section 120.60(1). The evidence establishes that when Nitty told Petitioner on January 21, 2015——notably, in response to communication that Petitioner initiated——that her license "was being denied," Respondent had not yet made its final decision to deny her application, so had not yet "approved or denied" Petitioner's license. Nitty's role in the application review process was limited to determining whether Petitioner previously had been terminated from the Florida Medicaid program, and, if so, to draft a denial letter for review and approval by her superiors. That is precisely what she did. Based on her confirmation that Petitioner had previously been terminated from the Florida Medicaid program, Nitty drafted a denial letter, which was then sent up Respondent's "chain of command" for approval or rejection, and, ultimately, for signature by Respondent's Deputy Secretary for Administration. The "chain of command" included her immediate supervisor, the bureau chief, the division director, and legal counsel——any and all of whom had the authority to reject her recommendation. To that point, Nitty acknowledged that the denial letter she drafted had "some rewrite issues" and that her supervisor, had, in fact, rewritten the letter. Nitty was not the person authorized by Respondent to make its final, binding decision to approve or deny Petitioner's application, and she did not know who actually made the ultimate decision to deny Petitioner's license renewal. Thus, at bottom, when Nitty told Petitioner that her license "was being denied," she was only conveying her preliminary assessment, as application review staff, that Petitioner's application was being denied. Nitty's communication of her preliminary assessment could not, and did not, constitute Respondent's "approval or denial" of Petitioner's application.7/ Thus, Respondent did not approve or deny Petitioner's application within the 90-day approval/denial period. Accordingly, pursuant to section 120.60(1), Petitioner's application is "considered approved." There is no evidence showing that, as of the date of the final hearing, Petitioner had notified Respondent's agency clerk of her intent to rely on the default license provision in section 120.60(1).
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order that: (1) acknowledges that Petitioner's application for renewal of License No. ME 74131 is considered approved pursuant to section 120.60(1), Florida Statutes, and (2) directs Respondent's agency clerk, upon Petitioner's notification to said agency clerk that complies with section 120.60(1), to issue Petitioner's license, which may include such reasonable conditions as Respondent is authorized by law to require. DONE AND ENTERED this 29th day of February, 2016, in Tallahassee, Leon County, Florida. S CATHY M. SELLERS 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 29th day of February, 2016.
The Issue This is a license discipline case in which a medical doctor is charged by administrative complaint with five counts of violations of paragraphs (h), (k), (m), and (t) of Section 458.331(1), Florida Statutes (1988 Supp.).
Findings Of Fact Findings based on parties' stipulations The Respondent, Vladimir Rosenthal, M.D., (hereinafter "Respondent" or "Dr. Rosenthal") is, and at all material times was, a medical doctor, license number ME 0045574, who practiced at 1320 South Dixie Highway, Coral Gables, Florida. Dr. Rosenthal at all material times owned the business operating as Today's Women Medical Center located at 1320 South Dixie Highway, Suite 1070, Coral Gables, Florida. On or about November 3, 1988, Dr. Rosenthal performed an elective abortion on patient B.F. under general anesthesia. On or about November 3, 1988, Dr. Rosenthal ordered a pathology report of the products of the procedure performed on patient B.F. The pathology report regarding patient B.F. bears the date November 8, 1988. The pathology report revealed no chorionic villi and recommended a "close follow-up" of the patient. Missed abortion and continued pregnancy is a recognized risk of early (first trimester) abortions. Patient B.F. suffered no harm as a result of the November 3, 1988, procedure. On or about December 7, 1988, patient B.F. presented to Dr. Rosenthal. On or about December 7, 1988, patient B.F.'s uterus was examined and found to be enlarged. Subsequently, a repeat pregnancy test was performed on patient B.F., which revealed she was still pregnant. On or about December 10, 1988, Dr. Rosenthal performed a second abortion on patient B.F. with positive results. Patient B.F. suffered no harm as a result of the December 10, 1988, procedure. Findings based on evidence at hearing The Respondent specializes in the area of gynecology, but does not practice obstetrics. In the course of his medical practice he regularly performs first trimester abortions. The Respondent is very experienced in the performance of first trimester abortions. In recent years he has averaged five thousand (5,000) such procedures per year. Patient B.F. normally goes to Dr. Nahid Mansoori for routine treatment of gynecological matters. Patient B.F. was seen by Dr. Mansoori on October 28, 1988, with a history of a missed menstrual period. Dr. Mansoori examined the patient and observed that the patient had an enlarged uterus and appeared to be 5 or 6 weeks pregnant. The patient expressed an interest in having an abortion. Because Dr. Mansoori does not perform abortions, she referred patient B.F. to the Respondent. Dr. Mansoori also referred patient B.F. to Dr. Martin S. Goldstein for an ultrasound examination. Dr. Mansoori referred patients to the Respondent on a regular basis. She did so for several reasons, including the facts that (a) patients she referred to the Respondent uniformly reported back to her that they were pleased or satisfied with the services they received from the Respondent, (b) none of her patients had complained about their treatment by the Respondent, and (c) none of the patients she had referred to the Respondent had experienced any infection or problems. On October 31, 1988, Dr. Martin S. Goldstein performed an ultrasound examination of patient B.F. On the basis of that ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 6 weeks, 0 days. Dr. Goldstein also concluded and reported that patient B.F. had an intrauterine pregnancy, thus ruling out an ectopic pregnancy. On November 3, 1988, patient B.F. went to the Respondent's clinic at 1320 South Dixie Highway for the purpose of having an abortion. The Respondent remembers this particular patient because she was a medical professional and her husband was an attorney. Because of their respective professions, the Respondent was extra careful to explain everything involved in the process to both B.F. and her husband. He especially explained to both of them the importance of a post-abortion follow up examination at either the Respondent's clinic or at the office of the patient's regular gynecologist. Patient B.F. said that she would return to Dr. Mansoori, her regular gynecologist, for the follow up examination. When patient B.F. went to the Respondent's clinic on November 3, 1988, she told the Respondent that she had had an ultrasound examination. The Respondent called Dr. Mansoori and Dr. Mansoori told him that the results of the ultrasound examination indicated a "gestational age" 1/ of six weeks and that the ultrasound examination confirmed an intrauterine pregnancy. Dr. Mansoori also mentioned that her clinical examination of patient B.F. indicated a "gestational age" of five or six weeks. Upon manual examination of the patient, the Respondent concluded, and noted in the patient's medical record, that patient B.F.'s uterus was enlarged to a size consistent with a "gestational age" of five weeks. Later that same day, the Respondent performed an abortion procedure on patient B.F. Following the abortion procedure, patient B.F. took antibiotic medication for several days, which medication had been prescribed and/or dispensed by the Respondent. The Respondent ordered a pathology report of the products of the abortion procedure performed on patient B.F. on November 3, 1988. The Respondent does not order pathology reports on all of his patients, but he did so in this case because it was an early pregnancy, and also because he wanted to take extra care in view of the professions of B.F. and her husband. The pathology laboratory is supposed to call Dr. Rosenthal on all "abnormal" reports. Sometimes the laboratory fails to call and sometimes the laboratory fails to send a written report. The Respondent has established office procedures for handling laboratory reports to try to prevent any reports from going astray and to identify those that do go astray so that follow up activity may be taken. Pursuant to the Respondent's established office procedures, all laboratory reports received at the clinic must be seen and signed by the Respondent before being placed in a patient chart. When a patient returns for her follow up visit, the laboratory report is reviewed during the course of that visit. If a laboratory examination has been ordered, but there is no laboratory report in the chart at the time of the follow up visit, the laboratory is called by telephone. The Respondent usually makes these calls himself. Pursuant to the Respondent's established office procedures, missing laboratory reports for patients who do not return for follow up visits or who return to their regular physicians for follow up visits are picked up when monthly reports to the Department of Health and Rehabilitative Services are compiled and submitted. In order to complete these monthly reports, a log is kept of every patient who has an abortion procedure performed at the Respondent's clinic. The information kept in the log and reported to DHRS includes: the date of surgery, the estimated "gestational age" of the patient, whether a pathology report was ordered, the results of the pathology report, and the date the pathology report was received by the clinic. Such forms were in use at the time B.F. was a patient at the Respondent's clinic. If any pathology reports "fell through the cracks," they were picked up each month when the reports were prepared. The reports are usually prepared on the ninth or tenth of each month. The implementation of these office procedures for the purpose of following up on laboratory reports is sufficient to comply with applicable standards of medical care. The pathology laboratory prepared a report regarding the material removed from patient B.F. during the November 3, 1988, abortion procedure. The written laboratory report was dated November 8, 1988. The most significant finding noted on the laboratory report was "no chorionic villi." Because of this finding, the laboratory report also stated: "close follow up of patient is recommended." The significance of the notation of "no chorionic villi" is that it indicates that the pathology laboratory examination did not reveal evidence of any fetal tissue or other "products of conception." The need for close follow up in this instance is because the absence of chorionic villi can be due to a number of different things. 2/ On November 18, 1988, patient B.F. went to Dr. Mansoori's office for a post-abortion follow up visit. At that time the patient was complaining of a vaginal "yeast" infection, a not uncommon occurrence following a course of antibiotic medication. Dr. Mansoori treated the patient's "yeast" infection with a prescription for Monistat Vaginal Cream. Dr. Mansoori's medical records for that day also include the following notations regarding the patient B.F.: "Had abortion by Today's Woman. Post AB check up O.K." 3/ Dr. Mansoori told patient B.F. to get back in touch with her if the patient missed her next menstrual period. On December 6, 1988, patient B.F. called Dr. Mansoori to report that she had missed her menstrual period. Dr. Mansoori advised her to return to the Respondent and patient B.F. agreed to do so. Dr. Mansoori called the Respondent to advise him that patient B.F. would be returning because she had missed her menstrual period. Dr. Mansoori also arranged for another ultrasound examination to be performed on patient B.F. by Dr. Goldstein. On December 7, 1988, patient B.F. returned to the Respondent's clinic where she was seen and examined by the Respondent. Examination revealed that the patient's uterus was mildly enlarged. A pregnancy test administered that day indicated that the patient was still pregnant. On December 7, 1988, the Respondent realized that he did not have a report from the pathology laboratory, so he called the laboratory and was advised that the most significant finding of the pathology report was "no chorionic villi." The substance of the telephone conversation with the pathology laboratory was noted in the patient's medical record. When he made the telephone call to the pathology laboratory on December 7, 1988, the Respondent had not received the laboratory's written report dated November 8, 1988, 4/ nor had he been otherwise advised of the results of the pathology study of the materials removed during the November 3, 1988, abortion procedure. On December 8, 1988, Dr. Martin S. Goldstein performed a second ultrasound examination of patient B.F. On the basis of the second ultrasound examination, Dr. Goldstein concluded and reported that the "gestational age" of patient B.F.'s pregnancy was 11 weeks, 6 days. This second gestational age was three days older than one would have predicted based on the October 31, 1988, ultrasound examination. In both of the ultrasound examinations of patient B.F., Dr. Goldstein relied upon the "crown rump" measurement as the basis for his estimate of "gestational age." On December 10, 1988, when patient B.F. returned to the Respondent's office for the second abortion procedure, the Respondent conducted a clinical examination of the patient before commencing the procedure. On the basis of his own clinical examination of the patient, the Respondent was of the opinion that patient B.F.'s "gestational age" was 8 or 9 weeks. He reported this on the "Physical Exam" portion of the patient's chart by writing "8-9" beside the entry for uterus. After the patient was anesthetized and the Respondent could examine her while she was more relaxed, the Respondent further examined the patient's uterus and was of the opinion that its size corresponded to a "gestational age" of 8 weeks. He noted this opinion in the "Operative Notes" portion of the patient's chart. It was, and continues to be, the Respondent's opinion that his December 10, 1988, estimates of the patient's "gestational age" were correct. Although he was aware of Dr. Goldstein's ultrasound examination which reported a somewhat older "gestational age," the Respondent had confidence in his own clinical findings and relied on his own clinical findings, which he duly recorded in the patient's medical chart. Relying on his own estimate of "gestational age," the Respondent performed the abortion procedure on December 10, 1988, on patient B.F. with a number eight suction tip. The abortion procedure was accomplished successfully and without any difficulty or complication. A report from a pathology laboratory confirmed that the December 10, 1988, abortion procedure was successful. 5/ The prevailing standards of acceptable care do not require a physician to order a pathology examination of the material removed during the course of a routine first trimester abortion procedure. In an abortion procedure involving a very early pregnancy, a physician may wish to order such a pathology examination in order to be more certain as to the results of the procedure, but it is a matter of physician preference, rather than a requirement. A physician who orders a pathology examination of the material removed during a first trimester abortion procedure has an affirmative duty to follow up on the examination and find out the results of the examination within a reasonable period of time. 6/ The Respondent's follow up on December 7, 1988, on the results of the pathology examination of the material removed from patient B.F. during the November 3, 1988, procedure was reasonable under the circumstances. 7/ The Respondent's delay until December 7, 1988, before following up on that pathology examination was not a departure from applicable standards of medical care. 8/ The Respondent's medical records for patient B.F. justify the course of treatment of the patient. The use of ultrasound examination as a method of estimating "gestational age" is not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of ultrasound examination are accurate within a margin of error of plus or minus two weeks. 9/ Clinical or manual examination of a patient as a method of estimating "gestational age" is also not an exact science and cannot be relied upon to determine an exact "gestational age." As a general rule, "gestational age" estimates derived by means of clinical or manual examination of a patient are accurate within a margin of error of plus or minus two weeks, if done by an experienced physician. It is not a departure from applicable standards of medical care for an estimate of "gestational age" to vary from the actual "gestational age" by as much as plus or minus two weeks when the estimate is based on the physician's clinical or manual examination of the patient. A reasonably prudent physician who is experienced in clinical or manual examination of patients for the purpose of estimating "gestational age" should rely on his own findings, even if those findings appear to conflict with findings based on ultrasound examination. Such a physician should also note his own findings on the patient's medical records, regardless of what is reported by the ultrasound. There is no great discrepancy between the estimate of "gestational age" reported in Dr. Goldstein's ultrasound report of December 8, 1988, and the Respondent's estimate of "gestational age" on December 10, 1988. The Respondent's notations in patient B.F.'s medical records on December 10, 1988, to the effect that her pregnancy was of a "gestational age" of eight weeks was an honest notation of the Respondent's clinical judgment and was not a statement the Respondent knew to be false. 10/ Similarly, those notations were not deceptive, untrue, or fraudulent representations. On or about August 3, 1989, the Respondent's clinic, known as Today's Woman Medical Center, located at Suite 1070, 1320 South Dixie Highway, Coral Gables, Florida, was inspected by an employee of the Office of Licensure and Certification of the Department of Health and Rehabilitative Services. 11/ At the time of that inspection the Respondent was not present at the clinic, there were no procedures being performed at the clinic, and there were no patients at the clinic.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that a Final Order be entered in this case DISMISSING all charges against the Respondent, Vladimir Rosenthal, M.D. DONE AND ENTERED this 2nd day of October, 1992, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of October, 1992.
The Issue Whether Respondent should take final action to deny Petitioner's application for licensure as a practical nurse on the grounds set forth in Respondent's Notice of Intent to Deny.
Findings Of Fact Petitioner is a native of Haiti, where she graduated from the Université d'Etat d'Haiti, l' École Nationale des Infirmières, Haiti's national nursing school, in 1993. Since 1997, she has lived and received mail at a residence in North Miami Beach, Florida, having the following mailing address: 1120 Northeast 155th Street, North Miami Beach (or, alternatively, Miami), Florida 33162 (155th Street Mailing Address). In or about 2006 and 2007, Petitioner attended the Miami Lakes Educational Center's practical nursing program, but she never completed the program. Thereafter, Petitioner enrolled in and later completed (in or about June 2008) a "remedial" program of practical nursing coursework specifically designed for graduates of Haiti's national nursing school. The coursework was given at Miami-Dade College (North), under the directorship of Mariane Barrientos. On April 23, 2009, Petitioner filed with Respondent an Application for Nursing Licensure by Examination seeking a license to engage in the practice of practical nursing in Florida (First Florida Application). On the completed application form, in the spaces provided for the applicant to indicate the "Nursing School Attended" and "Additional Nursing Program Attended," she wrote "Universite D'Etat Ecole Nationale Des Infirmières" and "Miami Dade College Remedial Theory & Clinical," respectively. By letter dated April 30, 2009, addressed to Petitioner at her 155th Street Mailing Address (with "Miami" designated as the city), the address she gave as her mailing address on her First Florida Application, Respondent advised Petitioner that it had received her First Florida Application and, upon review, had determined it to be "incomplete" because the following requirements had not been met: Graduates of schools outside the United States must have credentials evaluated by a Board approved credentialing service. . . . Evaluation results must be mailed directly to the Florida Board of Nursing. Copies from the applicant are not acceptable. Graduates of schools outside the United States must provide proof of Board approved English competency. . . . Results must be mailed directly to the Florida Board of Nursing. Copies from the applicant are not acceptable. After having received this letter, as well as follow-up written correspondence from Respondent dated August 12, 2009, also addressed to Petitioner's 155th Street Mailing Address (with "Miami" designated as the city), Petitioner withdrew her First Florida Application by completing a Respondent-created form (on which she gave her address as "1120 NE 155 St Miami Fl 33162") and submitting it to Respondent on October 27, 2009. Approximately two months later, in or around December 2009, Petitioner submitted an Application for License by Examination: Practical Nurse, to the Colorado Board of Nursing (Colorado Application). The application was accompanied by a money order (in the amount of $88.00) Petitioner had obtained to pay for the application fee. On the completed application form, under "Name of Professional Nursing Program Attended," "Miami Lakes Educational Center" was written; in the space provided for the applicant to indicate the "Date of Graduation," it was claimed, falsely, that Petitioner had graduated from this "[p]rofessional [n]ursing [p]rogram" in June 2009; and Petitioner gave her 155th Street Mailing Address (with "Miami" designated as the city) as her mailing address. At the end of the form was the following "Attestation," which Petitioner signed and dated on December 14, 2009: I state under penalty of perjury in the second degree, as defined in 18-8-503, C.R.S., that the information contained in this application is true and correct to the best of my knowledge. In accordance with 18- 8-501(2)(a)(1), C.R.S. false statements made herein are punishable by law and may constitute violation of the practice act. In support of the Colorado Application, the Colorado Board of Nursing received a fraudulent Miami Lakes Education Center transcript showing, falsely, that Petitioner had completed the nursing program at the school on June 29, 2009. The transcript purported to be signed (on December 11, 2009) by Dr. Angela Thomas-Dupree, who was an administrator at the Miami Lakes Education Center at the time. In fact, the signature on the transcript was a forgery: it was not Dr. Thomas-Dupree's, and she had not authorized anyone to sign her name on any transcript issued by the Miami Lakes Education Center.3/ In response to the Colorado Board of Nursing's request that she "verify [the] transcript" it had received (a copy of which the Board sent to her), Dr. Thomas-Dupree advised the Board, in writing (through a memorandum dated March 16, 2010), that (contrary to what the transcript indicated) Petitioner "[a]ttended [but] did not complete" the nursing program at the Miami Lakes Education Center. Thereafter, the Colorado Board of Nursing made its determination to deny Petitioner's Colorado Application on the ground that she had "attempted to procure a license by fraud, deceit, misrepresentation, misleading omission, or material misstatement of fact" in violation of Colorado law.4/ By letter dated June 25, 2010, addressed to Petitioner at her 155th Street Mailing Address (with "Miami" designated as the city), the Colorado Board of Nursing advised Petitioner that a decision had been made to "deny [her] request for a license." The body of the letter read as follows: Panel B of the State Board of Nursing ("Board") reviewed your application for a Practical Nurse license on June 23, 2010. After careful consideration of all of the information contained in your application file, it was the decision of the Panel to deny your request for a license based on C.R.S. §12-38-118 and §12-38-117(1)(a) and its determination that you: have procured or attempted to procure a license by fraud, deceit, misrepresentation, misleading omission, or material misstatement of fact; If you feel that you have additional information or documentation to submit that would change the outcome of the Panel's decision you may write a letter and request that your file and the supplemental information be re-examined by the Panel. Feel free to contact me if you have any questions regarding this process. Pursuant to sections §12-38-1-117, 12-38-118, and 24-4-104(9), C.R.S., you have the right to request a hearing regarding the denial of your application. In order to exercise this right, you must provide written notification to the Board at the above listed address within sixty days from the date of this letter specifically requesting a hearing. In the event that you do not make a timely request for a hearing, the denial will become final. At the end of the letter was a Certificate of Service, signed by the letter's author, certifying that the letter: was sent First Class Mail from Denver, Colorado, this 25th day of June 2010, addressed as follows: Benita S. Jean-Noel 1120 NE 155th Street Miami, FL 33162[5/] Petitioner received the Colorado Board of Nursing's June 25, 2010, letter,6/ but did not request a hearing on the decision to "deny [her] request for a license." The decision therefore became final, as the letter indicated it would. From approximately December 2011 to December 2012, Petitioner took additional nursing coursework at Sigma Institute of Health Careers (Sigma). On November 5, 2012, before graduating from Sigma, Petitioner filed with Respondent a second Application for Nursing Licensure by Examination seeking a license to engage in the practice of practical nursing in Florida (Second Florida Application). Her signature (dated September 5, 2012) was affixed on the line provided for the "Applicant's Signature" on the penultimate page (page 17) of the completed application form, and it was immediately preceded by a statement reading, in pertinent part, as follows: I, the undersigned, state that I am the person referred to in this application for licensure in the State of Florida. I recognize that providing false information may result in disciplinary action against my license or criminal penalties pursuant to Sections 456.067, 775.083, and 775.084, Florida Statutes. I have carefully read the questions in the foregoing application and have answered them completely, without reservations of any kind. Should I furnish any false information in this application, I hereby agree that such act shall constitute cause for denial, suspension or revocation of my license to practice as a Registered Nurse or Licensed Practical Nurse in the State of Florida. At the time she filled out and signed the application form, Petitioner knew that she had applied for licensure as a practical nurse in Colorado and that her application had been denied on the grounds that she had "attempted to procure [the applied-for] license by fraud, deceit, misrepresentation, misleading omission, or material misstatement of fact." Nonetheless, wanting to keep this damaging information from Respondent, in response to Question 6A on page 13 of the form, which was, "Have you ever been denied or is there now any proceeding to deny your application for any healthcare license to practice in Florida or any other state, jurisdiction or country?," she checked the "No" box, knowing her answer to be false. Question 6A was one of four questions in the "Disciplinary History" section of the form, at the end of which was the following directive: If you answered "Yes" to any of the above questions, please send a written letter of self explanation. You must contact the Board(s) in the State(s) in which you were disciplined. You must request official copies of the Administrative Complaint and Final Order be sent directly to the Florida Board of Nursing. Consistent with her having answered Question 6A in the negative, Petitioner did not, along with the submission of her completed Second Florida Application, "send a letter of self explanation" concerning the denial of her Colorado Application.7/ Despite Petitioner's nondisclosure, in its investigation of Petitioner's application, Respondent found out about the Colorado Board of Nursing's denial of her application in 2010, and it obtained a copy of the June 25, 2010, denial letter that Petitioner had received from the Colorado Board of Nursing. Thereafter, by letter dated November 15, 2012, addressed to Petitioner at her 155th Street Mailing Address (with "North Miami Beach" designated as the city), the address she gave as her mailing address on her Second Florida Application, Respondent directed Petitioner to, among other things, "[r]equest that the Board(s) in the state[s] where [she was] previously denied send official copies of the final order to the Florida Board of Nursing" and to also "[s]ubmit a self explanation in reference to the denial(s)." In response to this request, Petitioner wrote Respondent a letter in which she denied, falsely, ever even having applied for a license in any state, including Florida, in the past. Respondent, however, knew better. On February 15, 2013, it issued the Notice of Intent to Deny set out in the Preliminary Statement section of this Recommended Order. The Notice's Certificate of Service reflects that it was mailed to Petitioner at her 155th Street Mailing Address (with "North Miami Beach" designated as the city) on February 18, 2013. In response to the Notice, Petitioner wrote a letter to Respondent, dated March 4, 2013, claiming, falsely, that she "never applied to the Colorado Board of Nursing"8/ and expressing her "read[iness] to challenge any misconception or any misunderstanding regarding the matter." Respondent treated Respondent's letter as a request for hearing and, on March 12, 2013, referred the matter to DOAH for the assignment of an administrative law judge to conduct the requested hearing. The assignment was made, and the hearing was held, as noted above. The foregoing Findings of Fact are based on the evidence received at that hearing and the record as a whole.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board of Nursing issue a final order denying Petitioner's pending application for licensure as a practical nurse on the grounds alleged in the Board's February 15, 2013, Notice of Intent to Deny.12/ DONE AND ENTERED this 11th day of June, 2013, in Tallahassee, Leon County, Florida. S STUART M. LERNER 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 11th day of June, 2013.
