Conclusions Having reviewed the administrative complaint dated June 12, 2009, and Notice of Intent dated July 9, 2009, attached hereto and incorporated herein (Ex. 1 and 2), and all other matters of record, the Agency for Health Care Administration (“Agency”) has entered into a Settlement Agreement (Ex. 3) with the other party to these proceedings, and being otherwise well- advised in the premises, finds and concludes as follows: 1 Filed November 20, 2009 10:37 AM Division of Administrative Hearings. ORDERED: 1. The attached Settlement Agreement is approved and adopted as part of this Final Order, and the parties are directed to comply with the terms of the Settlement Agreement. 2. The administrative fine against the Respondent in AHCA Case No. 2009001632 is withdrawn. 3. The Respondent's abortion clinic license is cancelled. 4. The initial application seeking laboratory licensure in Case No. 2009007700 is withdrawn. 5. The Respondent's request for formal hearing is dismissed. 6. Each party shall bear its own costs and attorney’s fees. 7. The above-styled cases are hereby closed. DONE and ORDERED this _// day of hover Ake , 2009, in Tallahassee, Leon County, Florida. El . Arnold, Secretary Y t Health Care Administration Thomas Agenc A PARTY WHO IS ADVERSELY AFFECTED BY THIS FINAL ORDER IS ENTITLED TO JUDICIAL REVIEW WHICH SHALL BE INSTITUTED BY FILING ONE COPY OF A NOTICE OF APPEAL WITH THE AGENCY CLERK OF AHCA, AND A SECOND COPY, ALONG WITH FILING FEE AS PRESCRIBED BY LAW, WITH THE DISTRICT COURT OF APPEAL IN THE APPELLATE DISTRICT WHERE THE AGENCY MAINTAINS ITS HEADQUARTERS OR WHERE A PARTY RESIDES. REVIEW OF PROCEEDINGS SHALL BE CONDUCTED IN ACCORDANCE WITH THE FLORIDA APPELLATE RULES. THE NOTICE OF APPEAL MUST BE FILED WITHIN 30 DAYS OF RENDITION OF THE ORDER TO BE REVIEWED. Copies furnished to: Jan Mills Facilities Intake Unit Agency for Health Care Admin. (Interoffice Mail) Thomas M. Hoeler, Esquire | Office of the General Counsel Agency for Health Care Admin. (Interoffice Mail) Laura MacLafferty, Unit Manager Hospital and Outpatient Services Unit Agency for Health Care Admin. (Interoffice Mail) Andrew T. Lavin, Esquire Navon & Lavin, P.A. Emerald Park Office Center 2699 Stirling Road, Suite B-100 Fort Lauderdale, Florida 33312 (U.S. Mail) Karen Rivera, Unit Manager ‘| Laboratory Unit Agency for Health Care Admin. (Interoffice Mail) CERTIFICATE OF SERVICE I HEREBY CERTIFY that a true and correct copy of this Final Order was served on the above-named person(s) and entities by U.S. Mail, or the method designated, on this the /8 day of AGI A , 2009. Richard Shoop, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Building #3 Tallahassee, Florida 32308-5403 (850) 922-5873 Certified Mail Receipt (7003 1010 0000 9715 3702) STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Petitioner, AHCA No.: 2009001632 vs. COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC., Respondent. ADMINISTRATIVE COMPLAINT COMES NOW the Agency for Health Care Administration (hereinafter “AHCA”), by and through the undersigned counsel, and files this Administrative Complaint. against Community Healthcare Center of Pensacola, Inc. (hereinafter “Community Healthcare Center of Pensacola, Inc.”), pursuant to Section 120.569, and 120.57, Fla. Stat. (2008), alleges: NATURE OF THE ACTION 1. This is an action to impose one (1) administrative fine against Community Healthcare Center of Pensacola, Inc. in the amount of Four Hundred and Thirteen Thousand Dollars ($413.000), based upon one (1) deficiency, pursuant to Section 483.091, Fla. Stat. (2008). EXHIBIT 1. i \ JURISDICTION AND VENUE 2. This Agency has jurisdiction pursuant to 483, Part I and Section 120.569 and 120.57, Fla. Stat. (2008). 3. Venue lies in Escambia County, Pensacola, Florida, pursuant to Section 120.57 Fla. Stat. (2008); Rule 58A-5, Fla. Admin. Code (2008) and Section 28.106.207, Fla. Stat. (2008). PARTIES 4. AHCA, is the regulatory authority responsible for licensure and enforcement of all applicable statutes and rules governing clinical laboratory facilities pursuant to Chapter 483, -Part 1, Fla. Stat. (2008) and Rule 58A-5, Fla. Admin. Code (2008). 5. Community Healthcare Center of Pensacola, Inc. is a for-profit corporation, ABO Group + RH clinical laboratory facility is located at 6770 North Ninth Avenue, Pensacola, Florida 32504. Community Healthcare Center of Pensacola, Inc. is licensed as clinical laboratory facilities license # 800003116; certificate number #60474, effective November 21, 2005 through November 20, 2007. Community Healthcare Center of Pensacola, Inc. was at all times material hereto, licensed facility under the licensing authority of AHCA, and required to comply with all applicable rules, and statutes. COUNTI COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC. BASED ON RECORD REVIEW, OBSERVATIONS AND INTERVIEW WITH THE FACILITY ADMINISTRATOR ON JANUARY 7, 2009, AT APPROXIMATELY 9:30 A.M., IT WAS DETERMINED THAT THE LABORATORY LICENSE AND HAD CONTINUED TO PERFORM LABORATORY TESTING. STATE TAG L001-CLINICAL LABORATORY LICENSE Section 483.091, Fla. Stat. (2007) CLINICAL LABORATORY LICENSE 6. AHCA re-alleges and incorporates paragraphs (1) through (5) as if fully set forth herein. 7. On or about January 7, 2009, AHCA conducted a biennial survey at the Respondent’s facility. AHCA cited the Respondent based on the findings below, to wit: 8. On or about January 7, 2009, based on record review, observation, and interview with the facility administrator on January 7, 2009, at approximately 9:30 a.m., it was determined that the laboratory had not renewed the State of Florida clinical laboratory license and had continued to perform laboratory testing. 9. Review of state licensure records prior to the survey showed that the facility's laboratory license, number 800003116, had expired on November 20, 2007 and there was no pending application. 10. Review of Rh testing, hematocrit testing records, and pregnancy testing records showed documentation of test results for patient testing that had been performed between November 20, 2007 and January 6, 2009. ll. Observation of the Florida Clinical Laboratory license on display in a frame in the laboratory showed that the license had expired on November 20, 2007. 12. The administrator stated that the laboratory did not have a new state clinical laboratory license and did not realize they had not renewed the Florida license. The administrator stated that the facility had not received the renewal letter prior to the expiration of the license and had not received the "failed to renew" letter from the Agency for Health Care Administration following expiration of the license. Plan of Correction must be completed by February 21, 2009. 13. The regulatory provision of the Florida Statutes and Agency Rules (2008), that are pertinent to this alleged violation read as follows: 483.091 Clinical laboratory license A clinical laboratory may not send a specimen drawn within this state to any clinical laboratory outside the staté for examination unless the out-of-state laboratory has obtained a license from the agency. A new license may be secured for thé new location before the actual change, if the contemplated change complies with this part, part II of chapter 408, and the applicable rules. ek 483.221 Administrative fines.— In determining the penalty to be imposed, the Agency must consider, inter alia, the severity of the violation, actions taken by the licensee to correct the violation, any previous violations by licensee, and the financial benefit to the licensee of committing or continuing the violation. * ko ® 408.804 License required; display.— (1) It is unlawful to provide services that require licensure, or operate or maintain a provider that offers or provides services that require licensure, without first obtaining from the agency a license authorizing the provision of such services or the operation or maintenance of such provider. (2) A license must be displayed in a conspicuous place readily visible to clients who enter at the address that appears on the license and is valid only in the hands of the licensee to whom it is issued and may not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. The license is valid only for the licensee, provider, and location for which the license is issued. 408.812 Unlicensed activity.— (3) It is unlawful for any person or entity to own, operate, or maintain an unlicensed provider. If after receiving notification from the agency, such person or entity fails to cease operation and apply for a license under. this part and authorizing statutes, the person or entity shall be subject to penalties as prescribed by authorizing statutes and applicable rules. Each day of continued operation is a separate offense. (5) When a controlling interest or licensee has an interest in more than one provider and fails to license a provider rendering services that require licensure, the agency may revoke all licenses and impose actions under s. 408.814 and a fine of $1,000 per day, unless otherwise specified by authorizing statutes, against each licensee until such time as the appropriate license is obtained for the unlicensed operation. 15. Despite being unlicensed, Respondent continued to conduct laboratory testing and continued to reap the financial benefit of conducting said testing. 16. The violation alleged herein constitutes a deficiency, and warrants a fine of $413,000. 17. The Respondent's history of failing to timely renew its license, coupled with Respondent’s performance of unlicensed clinical laboratory testing resulting in financial gain in the face of Agency notification advising of the expiration of the license and the consequences of unlicensed activity, serve as a basis for the instant action and are, inter alia, a consideration of the Petitioner in determining the penalty sought herein. 18. Unlicensed laboratory testing is testing without Agency oversight and may result in substandard laboratory protocols and results which place the health and welfare of Respondent’s patients in danger. 19. The violation alleged herein constitutes a deficiency, and warrants a fine of $413,000. WHEREFORE, AHCA demands the following relief: 1. Enter factual and legal findings as set forth in the allegations of this administrative complaint. 2. Impose a fine in the amount of $413,000. CLAIM FOR RELIEF WHEREFORE, the Petitioner, State of Florida Agency for Health Care Administration requests the following relief: 1. Make factual and legal findings in favor of the Agency on Count I. 2. Impose upon Community Healthcare Center of Pensacola, Inc. an administrative fine in the amount of $413,000 for the violation cited above. 3. Grant such other relief as the court deems is just and proper. Respondent is notified that it has a right to request an administrative hearing pursuant to Section 120.569, Florida Statutes (2008). Specific options for administrative action are set out in the attached Election of Rights (one page) and explained in the attached Explanation of Rights (one page). All requests for hearing shall be made to the Agency for Health Care Administration, and delivered to the Agency for Health Care Administration, Building 3, MSC #3, 2727 Mahan Drive, Tallahassee, Florida 32308; Michael O. Mathis, Senior Attorney. RESPONDENT IS FURTHER NOTIFED THAT THE FAILURE TO REQUEST A HEARING WITHIN 21 DAYS OF RECEIPT OF THIS COMPLAINT WILL REASULT IN AN ADMISSION OF THE FACTS ALLEGED IN THE COMPLAINT AND THE ENTRY OF A FINAL ORDER BY THE AGENCY. Florida. Michael O. Mathis Fla. Bar. No. 0325570 Counsel of Petitioner, Agency for Health Care Administration . Bldg. 3, MSC #3 2727 Mahan Drive Tallahassee, Florida 32308 (850) 922-5873 (office) (850) 921-0158 (fax) CERTIFICATE OF SERVICE L HEREBY CERTIFY, that a true and correct copy of the foregoing has been served by certified mail on pat day of ark , 2009 to Warren Do Taylor, Administrator, Community Healthcare Center of Pensacola, Inc., 6770 North Ninth Avenue, Pensacola, Florida 32504. Michael O. Mathis, Esq. STATE OF FLORIDA : AGENCY FOR HEALTH CARE ADMINIS: RATION RE: Case Name: COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC. CASE NO: 2009001632 ELECTION OF RIGHTS This Election of Rights form is attached to a proposed administrative action by the Agency for Health Care Administration (AHCA). The title may be Notice of Intent to Deny, Notice of Intent to Impose a Late Fee, Notice of Intent to Impose a Late Fine, Administrative Complaint, or some other notice of intended action by AHCA. An Election of Rights must be returned by mail or by fax within 21 days of the day you receive the attached Notice of Intent to Deny, Notice of Intent to Impose a Late Fee, Notice of Intent to Impose a Late Fine, Administrative Complaint or any other proposed action by AHCA. If an election of rights with your selected option is not received by AHCA within twenty-one (21) days from the date you received a notice of proposed action by AHCA, you will have given up your right to contest the Agency’s proposed action and a final order will be issued. PLEASE RETURN YOUR ELECTION OF RIGHTS TO: Agency for Health Care Administration Attention: Agency Clerk 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florida 32308. Phone: 850-922-5873 Fax: 850-921-0158. PLEASE SELECT ONLY 1 OF THESE 3 OPTIONS OPTION ONE (1) I admit to the allegations of facts and law contained in the Notice of Intent to Deny, the Notice of Intent to Levy a Late Fee, the Notice of Intent to Levy a Late Fine, the Administrative Complaint, or other notice of intended action by AHCA and I waive my right to object or to have a hearing. | understand that by giving up my right to a hearing, a final order will be issued that adopts the proposed agency action and imposes the penalty, fine or action. OPTION TWO (2) I admit to the allegations of facts contained in the Notice of Intent to Deny, the Notice of Intent to Levy a Late Fee, the Notice of Intent to Levy a Late . Fine, the Administrative Complaint, or other proposed action by AHCA, but I wish to be heard at an informal proceeding (pursuant to Section 120.57(2), Florida Statutes) where I may submit testimony and written evidence to the Agency to show that the proposed administrative action is too severe or that the fine should be reduced. OPTION THREE (3)___ I do dispute the allegations of fact contained in the Notice of Intent to Deny, the Notice of Intent to Levy a Late Fee, the Notice of Intent to Levy a Late Fine, the Administrative Complaint, or other proposed action by AHCA, and I request a formal hearing (pursuant to Section 120.57(1), Florida Statutes (2006) before an Administrative Law Judge appointed by the Division of Administrative Hearings. PLEASE NOTE: Choo ; OPTION THREE (3), by itself, i ‘OT sufficient to obtain a formal hearing. You musi file a written petition in order to obt. «a formal hearing before the ‘Division of Administrative Hearings under Section 120.57(1), Florida Statutes. It must be received by the Agency Clerk at the address above within 21 days of receipt of this proposed administrative action. The request for formal hearing must conform to the requirements of Rule 28-106.201, Florida Administrative Code, which requires that it contain: 1. The name and address of each agency affected and each agency’s file or identification number, if known; 2. Your name, address, and telephone number, and the name, address, and telephone number of your representative or lawyer, if any; 3. An explanation of how your substantial interests will be affected by the Agency’s proposed action; 4. A statement of when and how you received notice of the Agency’s proposed action; ; 5. A statement of all disputed issues of material fact. If there are none, you must state that there are none; . 6. A concise statement of the ultimate facts alleged, including the specific facts you contend warrant reversal or modification of the Agency’s proposed action; 7. A statement of the specific rules or statutes you claim require reversal or modification of the Agency’s proposed action; and 8. A statement of the relief you are seeking, stating exactly what action you wish the Agency to take with respect to its proposed action. Mediation under Section 120.573, Florida Statutes, may be available in this matter if the Agency agrees. Facility type: (ALF? nursing home? medical equipment? Other type?) Facility Name: License number: Contact person(or attorney or representative): Name Title Address: ; Street and number City Zip Code Telephone No. ; Fax No. Email Signed: Date: NOTE: If your facility is owned or operated by a business entity (corporation, LLC, etc.) please include a written statement from one of the officers or managers that you are the authorized representative. If you are one of the managers or officers, please state which office you hold. ‘Entity name: Name of office you hold: You, your attorney or representative may reply according Subsection 120.54 Florida Statutes (2006) and Rule 28, Florida Administrative Code or you may use this recommended form. Lee teoF 70d FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION RN on T Better Health Care for all Floridians Oana N July 9, 2009 CERTIFIED MAIL / RETURN RECEIPT REQUESTED WARREN TAYLOR MD COMMUNITY HEALTHCARE CTR OF PENSACOLA INC LICENSE NUMBER: 800003116 6770 NORTH NINTH AVENUE PENSACOLA, FL 32504-7346 CASE #: 2009007700 NOTICE OF INTENT TO DEEM APPLICATION INCOMPLETE AND WITHDRAWN FROM FURTHER REVIEW Your application for license RENEWAL is deemed incomplete and withdrawn from further consideration pursuant to Section 408.806(3)(b), Florida Statutes, which states that “Requested information omitted from an application for licensure, license renewal, or change of ownership, other than an inspection, must be filed with the agency within 21 days after the agency’s request for omitted information or the application shall be deemed incomplete and shall be withdrawn from further consideration and the fees shall be forfeited’’. You were notified by correspondence dated June 05, 2009 to provide further information addressing identified apparent errors or omissions within twenty-one days from the receipt of the Agency’s correspondence. Our records indicate you received this correspondence by certified mail on June 09, 2009. As this requested information was not timely received by the Agency, your application is deemed incomplete and withdrawn from further consideration. The outstanding issues remaining for licensure are: Failure to submit upon written request: e Health Care Licensing Application Addendum with ownership information in Section 2A. EXPLANATION OF RIGHTS Pursuant to Section 120.569, F.S., you have the right to request an administrative hearing. In order to obtain a formal proceeding before the Division of Administrative Hearings under Section 120.57(1), F.S., your request for an administrative hearing must conform to the requirements in Section 28-106.201, Florida Administrative Code (F.A.C), and must state the material facts you dispute. ECTION AND EXPLANATION OF RIGHTS FORMS. Karen Rivera, Manager — . Laboratory Licensure Unit Certified Article Number 7460 3901 9848 4334 8301 SENDERS. RECORD cc: Agency Clerk, Mail Stop 3 Legal Intake Unit, Mail Stop 3 2727 Mahan Drive,MS#32 Tallahassee, Florida 32308 h EXHIBIT STATE OF FLORIDA AGENCY FOR HEALTH CARE ADMINISTRATION STATE OF FLORIDA, AGENCY FOR DOAH No. 09-3585 HEALTH CARE ADMINISTRATION, Petitioner, vs. AHCA No. 2009001632 COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC., Respondent. COMMUNITY HEALTHCARE CENTER OF PENSACOLA, INC., Petitioner, vs. AHCA No. 2009007700 STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, Respondent. / SETTLEMENT AGREEMENT The State of Florida, Agency for Health Care Administration (“the Agency”), and the licensee/applicant, Community Healthcare Center of Pensacola, Inc. (“the Provider”), pursuant to Section 120.57(4), Florida Statutes, enter into this Settlement Agreement (“Agreement”) and agree as follows: WHEREAS, the Provider is a licensed abortion clinic pursuant to Chapter 408, Part II, Chapter 390, Florida Statutes, and Chapter 59A-9, Florida Administrative Code, and is also an applicant for clinical laboratory licensure pursuant to Chapter 408, Part II, Chapter 483, Part I, Florida Statutes, and Chapter 59A-7, Florida Administrative Code; and WHEREAS, the Agency has jurisdiction by virtue of being the licensiy EXHIBIT Page 1 of 5 authority over the Provider pursuant to the above referenced provisions of law; and WHEREAS, the Agency served an Administrative Complaint dated June 12, 2009, on the Provider; and WHEREAS, the Agency served a Notice of Intent to Deem Application Incomplete and Withdrawn from Further Review (“NOIW”) dated July 9, 2009, on the Provider; and WHEREAS, the parties have agreed that a fair, efficient, and cost effective resolution of this dispute would avoid the expenditure of substantial sums to litigate the dispute; and WHEREAS, the parties have negotiated in good faith and agreed that the best interest of all the parties will be served by a settlement of this proceeding; NOW THEREFORE, in consideration of the mutual promises and recitals herein, the parties intending to be legally bound, agree as follows: 1. All recitals are true and correct, are incorporated into the Agreement and are binding findings of the parties. 2. Upon full execution of this Agreement, the Provider agrees to waive any and all appeals and proceedings to which it may be entitled including, but not limited to, an informal proceeding under Subsection 120.57(2), Florida Statutes, a formal proceeding under Subsection 120.57(1), Florida Statutes, appeals under Section 120.68, Florida Statutes; and declaratory and all writs of relief in any court or quasi-court (DOAH) of competent jurisdiction; and agrees to waive compliance with the form of the Final Order (findings of fact and conclusions of law) to which it may be entitled, provided, however, that no agreement herein shall be deemed a waiver by either party of its right to judicial enforcement of this Agreement. 3. Upon full execution of this Agreement, the Agency agrees to voluntarily dismiss the Administrative Complaint against the Provider with prejudice foregoing the administrative fine sought to be imposed against the Provider in its entirety, and the Provider agrees to: (1) the Page 2 of 5 voluntarily relinquishment of its abortion clinic license (License No. 821) and closure of the abortion clinic effective on or before October 31, 2009, (2) the surrender of the license certificate to the Agency at “Hospital and Outpatient Unit, Agency for Health Care Administration, 2727 Mahan Drive, MS #31, Tallahassee, Florida 32308” immediately upon the discontinuance of the operation of its clinic, (3) the withdrawal of its petition for formal hearing with regard to the pending Administrative Complaint, and (4) the withdrawal of its initial application for clinical laboratory licensure which is the subject of the NOIW. As part of the closure of its clinic, the Provider recognizes that it must comply with all statutes and rules regarding its closure, including but not limited to, Section 408.810 and Section 456.057, Florida Statutes. Until the license is voluntarily relinquished, the Provider recognizes that it must comply with all statutes and rules required by its licensure, including but not limited to, the reporting requirements under Section 390.0112, Florida Statutes, and Rule 59A-9.034, Florida Administrative Code. The Provider agrees to submit a final report for the final month or partial final month of operation, and if unable to do so through the Agency’s on-line system, may do so by United States mail at the above-referenced address. 4. Venue for any action brought to interpret, enforce or challenge the terms of this Agreement and its corresponding Final Order shall lie solely in the Circuit Court of Florida, in and for Leon County, Florida. 5. By executing this Agreement, the Provider does not admit the allegations raised in the Administrative Complaint and NOIW, but recognizes that the Agency continues in good faith to assert these allegations. 6. Upon full execution of this Agreement, the Agency shall enter a Final Order adopting and incorporating the terms of this Agreement and closing the above-styled cases. 7. Each party shall bear its own costs and attorney’s fees. Page 3 of 5 8. This Agreement shall become effective on the date upon which it is fully executed by all parties. 9. The Provider, for itself and any controlling interests, parent corporations, subsidiary corporations, successors, transferees, and any related entities, discharges the State of Florida, Agency for Health Care Administration, and its agents, representatives, and attorneys of and from all claims, demands, actions, causes of action, suits, damages, losses, and expenses, of any and every nature whatsoever, arising out of or in any way related to this matter and the Agency’s actions, including, but not limited to, any claims that were or may be asserted in any federal court, state court or administrative forum, including any claims arising out of this Agreement, by or on behalf of the Provider. 10. This Agreement is binding upon all parties and those identified in the above paragraph of this Agreement. 11. In the event that the Provider was a Medicaid provider at the time of the occurrences alleged in the administrative complaint, this Agreement does not prevent the Agency from seeking Medicaid overpayments related to the subject issues or from imposing any further sanctions pursuant to Rule 59G-9.070, Florida Administrative Code. 12, The undersigned have read and understand this Agreement and have the authority to bind their respective principals to it. The Provider’s representative has the legal capacity to execute the Agreement and has consulted with independent counsel. The Provider understands that counsel for the Agency represents solely the Agency and that counsel for the Agency has not provided any legal advice to, or influenced, the Provider in its decision to enter into the Agreement. 13. This Agreement contains and incorporates the entire understandings of the parties. This Agreement supersedes any prior oral or written agreements between the parties. This Page 4 of 5 Agreement may not be amended or supplemented except in writing. Any attempted assignment of this Agreement shall be void. 14. All parties agree that a facsimile signature suffices for an original signature. The following representatives acknowledge that they are duly authorized to enter into this Agreement. Elizabeth Deputy Se Agency for Health Care Administration Community Healthcare Center of Pensacola 2727 Mahan Drive, Bldg. #1 6770 North Ninth Avenue Tallahassee, Florida 32308 Pensacola, Florida 32504 DATED: Mf 7 2007 DATED: w\ | 04 COoUNAL 0 Grmun Reronice ht or nn : . Andrew T. Lavin, Esquj Office of the General Counsel Navon & Lavin, P.A. Agency for Health Care Administration Emerald Park Office Center 2727 Mahan Drive, Mail Stop #3 2699 Stirling Road, Suite B-100 Fort Lauderdale, Florida 33312 DATED: u/ 19]04 DATED: “4 Thomas M. Hoeler, Senior Attorney Office of the General Counsel Agency for Health Care Administration 2727 Mahan Drive, Mail Stop #3 Tallahassee, Florig& 32708 DATED: Page 5 of 5
The Issue Whether respondent's license to practice medicine should be disciplined on grounds that: (1) he engaged in gross or repeated malpractice or failed to practice medicine with the required level of care, skill, and treatment, and (2) he is unable to practice medicine with the requisite skill and safety by reason of illness or as a result of a mental or physical condition.
Findings Of Fact Based upon the evidence presented at hearing, the following facts are determined: Respondent is an 80-year-old physician licensed to practice medicine in Florida. He has been a general practitioner in the Miami area for over 40 years; during that time, he has earned the respect and esteem of the medical community. During the 1940s, he helped establish the first cancer clinic in Dade County; he is recognized as one of the community's early medical pioneers. He has never before been the subject of a disciplinary action for professional misconduct. (Testimony of Bishop, Boughton; R-2.) I. The Claresta Halloran Abortion On July 3, 1980, Ms. Claresta Halloran, age 35, visited respondent's office for a therapeutic abortion. She told respondent that her last menstrual period was "sometime in April." (P-3.) Respondent palpated her, examined her by use of a sounding instrument, and dilated her uterus. After determining that she was approximately 12 weeks pregnant, respondent attempted to abort the fetus by suction and curettage. Fearing that he had perforated Ms. Halloran's uterus, respondent had her transported to North Miami General Hospital for an exploratory laparotomy. Results of the exploratory surgery were negative; there was no evidence of perforation of the uterus or injury to the bowel. (Testimony of Boughton; P-3.) William Wickman, M.D., performed the exploratory surgery on Ms. Halloran at the hospital. His bimanual examination revealed an enlarged uterus, "the size of approximately [a] 12 week pregnancy." (Testimony of Boughton; P-3.) Two days after the surgery, Ms. Halloran passed a macerated fetus which, after pathological examination, was estimated to be of 17 weeks' gestation. Her convalescence from surgery was otherwise uneventful and she was discharged from the hospital the next day, July 6, 1980. (Testimony of Boughton; P-3.) Absent specialized training, abortions "from below," that is, by dilating the cervix and removing the contents of the uterus, should not be performed on pregnancies which have progressed beyond 12-weeks. This is because, after 12 weeks, the fetus's bones have developed calcium and sharp, razor-like edges which can perforate the uterus and endanger the health and safety of the patient. (Testimony of Rudolph.) Respondent has not received specialized training which would enable him to safely use the "from below" method on pregnancies beyond 12 weeks. However, his examination of Ms. Halloran led him to believe she had been pregnant for 12 weeks. In reaching that conclusion, he did not rely solely on the date of the patient's last menstrual period. His palpation and examination of the patient's uterus confirmed that the pregnancy was approximately 12 weeks. Dr. Wickman's subsequent examination of the patient at the hospital confirmed that the patient's uterus indicated an approximate 12-week pregnancy. (Testimony of Rudolph, Boughton; P-3.) There are other more advanced methods, such as sonography, which enable one to more accurately determine the gestational age of a fetus. However, the evidence does not support a finding that respondent's failure to use such methods constitutes malpractice or a failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. (Testimony of Rudolph.) Respondent admits that he erred in his diagnosis of the stage of Ms. Halloran's pregnancy. However, his diagnosis was not shown to have been unjustified or unreasonable in light of the facts known to him at the time. Both the date of the patient's last menstrual period and manual examination of the uterus supported a determination that the pregnancy was approximately 12 weeks. The "from below" abortion procedure which respondent utilized is only unacceptable for use on pregnancies in excess of 12 weeks. In short, respondent's treatment of the patient was consistent with his diagnosis. While the diagnosis was in error -- the fetus was of 17 weeks' gestation, not 12 weeks -- other physicians, under similar circumstances, would likely have made the same error. (Testimony of Boughton; P-3.) II. The Wilhemina Evans Abortion On August 5, 1980, Ms. Wilhemina Evans, age 18, visited respondent's office for a therapeutic abortion. She told respondent that her last menstrual period was at the end of April. He palpated her, placed a sounding instrument, and dilated her uterus. After concluding that she was at least 13 weeks pregnant; 2/ he attempted to abort the fetus "from below" by use of placental forceps and a curette. He thought the abortion had been successful and permitted the patient to, return home. (Testimony of Rudolph, Boughton; P-4.) The next day, the patient went to Jackson Memorial Hospital complaining of abdominal pain. Several minutes after arriving at the emergency room, she passed a 750-gram male still-born fetus. Subsequent pathological examination indicated that the fetus was of 24 weeks' gestation. (P-4.) Respondent failed, in several respects, to provide Ms. Evans with treatment which is recognized by a reasonably prudent similar physician as acceptable under similar circumstances. Without special training, the "from below" method of aborting the fetus should not have been used on a woman beyond 12 weeks pregnant. 3/ Moreover, if respondent was uncertain of the gestational age of the fetus, he should not have attempted to abort the fetus "from below" in an office setting. Despite the patient's obesity, respondent should have been able to determine the advanced gestational stage of the fetus. Finally, a reasonably prudent similar physician would have realized that the attempted abortion had been unsuccessful and would not have permitted the patient to immediately return home. Thus, it is concluded that respondent's treatment of Ms. Evans was inconsistent with acceptable medical practice. 4/ (Testimony of Rudolph.) III. Treatment of Skin Lesions of Bernice Riordan Since 1951, Bernice Riordan, age 68, has been a patient of respondent's. Over the years, he treated her for various ailments, including basal cell carcinomas and squamous cell carcinomas on her face and neck. He used different techniques to treat the carcinomas; electrocoagulation in 1955; electrodesiccation and silver nitrate in 1961, 1962, 1972, and 1976; bichloracetic acid in 1976; and 5-Fluorouracil in 1978. In April, 1961, respondent referred Ms. Riordan to a dermatologist for specialized treatment. In 1969, he referred her to Jackson Memorial Hospital for radiation therapy because of multiple lesions on her face. She was a difficult and eccentric patient; she continually resisted his efforts to refer her to specialists for treatment of her increasingly serious carcinomas. Finally, in 1980, he referred her to two specialists -- a plastic surgeon and another dermatologist. By 1980, the cancer of the skin on her face had destroyed the entire nose and perioral skin. (Testimony of Boughton; P-2.) The Department presented, by deposition, the testimony of Dr. Richard C. Childers, a dermatologist who had reviewed the patient records of Ms. Riordan. He graduated from medical school in 1969 and was licensed to practice medicine in Florida in 1971. Since 1974, he has engaged in the private practice of dermatology in Gainesville, Florida, with a clinical appointment at Shands Teaching Hospital. It was Dr. Childers' opinion that respondent should have referred Ms. Riordan, no later than 1959, to a specialist for treatment of recurring skin lesions. Dr. Childers also opined that respondent, on numerous occasions over the years, had used ineffective or inappropriate treatment techniques on Ms. Riordan's lesions. (P-2.) Dr. Childers' testimony is rejected as inadequate to establish that respondent failed to provide treatment to Ms. Riordan which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances. Dr. Childers is a specialist in dermatology, not a general practitioner. He practices in Gainesville, not Miami. When respondent applied many of the complained of treatment techniques to Ms. Riordan, Dr. Childers had not yet begun medical school. It would be patently unfair to measure treatment for carcinomas furnished by a general practitioner in 1961 by a specialist's with the standard of care applicable to general practitioners in the Miami area during the period in question. to establish an appropriate standard of care applicable to respondent's treatment of Ms. Riordan. (Testimony of Boughton; P-2.) IV. Respondent's Ability to Practice Medicine with Reasonable Safety to His Patients On April 27 and 30, 1981, a mental status examination was given psychiatrist's opinion, respondent's appearance, behavior, and overall thinking was intact; there was no evidence of psychosis. However, respondent's response was somewhat impaired. Dr. Bishop concluded that respondent suffers from of Bishop.) Respondent recognizes that his advanced age affects his ability to However, he believes that he is able to operate an office practice with reasonable skill and safety and without endangering his patients. He is willing his work. The practice of medicine is his avocation as well as his profession; it is the habit and pleasure of his life. (Testimony of Boughton.) interfere with his ability to practice medicine with reasonable skill and safety to his patients. The ability to remember facts is essential to a physician's patient's illness. (Testimony of Bishop.) However, the evidence is insufficient to demonstrate that respondent's his livelihood. The evidence on the extent which his impairment will affect his ability to practice is problematic. He is willing to submit to the supervision supervision of another physician, it is likely that he will be able to practice medicine with reasonable skill and safety to his patients. (Testimony of
Recommendation Based on the foregoing, it is That respondent's license to practice medicine be suspended until respondent submits to the Board an acceptable proposal which ensures that his the Board approves the proposal, respondent should be placed on a probationary status and his practice restricted to exclude the performance of surgery and DONE AND RECOMMENDED this 20th day of November, 1981, in Tallahassee, Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 20th day of November, 1981.
The Issue This is a case in which the Petitioner seeks to suspend, revoke, or take other disciplinary action against the Respondent as licensee and against his license to practice medicine in the State of Florida. In a two count Administrative Complaint the Respondent is alleged to have violated paragraphs and (h) of Subsection 458.331(1), Florida Statutes, by failing to report to the Department certain activities he is alleged to have witnessed, and is alleged to have violated paragraph (t) of Subsection 458.331(1), Florida Statutes, by failing to take certain specified actions which it is alleged should have been taken by a reasonably prudent physician acting under similar conditions and circumstances. Because of the somewhat unusual nature of this case, the principal allegations of the Administrative Complaint are set forth below to give context to the remainder of this Recommended Order. 1/ * * * COUNT ONE On or about March 16, 1982, Respondent was present at the delivery of a male infant to Mary Jones, reportedly to serve as the supervising physician to three (3) midwives performing the delivery. The delivery was performed by Margaret Hebson, Linda Wilson and Ricky Taylor. Hebson, Wilson and Taylor are not licensed to practice midwifery in the State of Florida, a fact which was known or should have been known to Respondent. Based upon the foregoing, Respondent has violated Section 458.331(1)(f), Florida Statutes, by failing to report to the Department any person who the licensee knows in violation of this Chapter or of the rules of the Department or the Board. Based upon this violation, Respondent has violated Section 458.331(1)(h), Florida Statutes, by failing to perform any statutory or legal obligation placed upon a licensed physician. * * * COUNT TWO Given Jones medical history, a reasonably prudent similar physician acting under similar conditions and circumstances would have ordered Jones transferred to the hospital rather than allow a home delivery to take place. Respondent did not. Respondent further failed to act prudently and to fulfill the duties that a responsible supervising physician acting under similar conditions and circumstances would have fulfilled by failing to examine Jones prior to delivery, failing to furnish obstetrical care when needed during delivery and failing to order Jones transferred to the hospital when it became apparent that Jones was suffering a prolonged labor. Following delivery the infant went into respiratory arrest and expired. A reasonably prudent physician acting under similar conditions and circumstances would have properly CPR to resuscitate the infant. Respondent did not. Based upon the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes, by failing to practice medicine with that level of care, skill and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances.
Findings Of Fact Based on the stipulations of the parties, on the exhibits received in evidence, and on the testimony of the witnesses, I make the following findings of fact. The Respondent, Albert A. Sneij, is a licensed medical doctor, having been issued license number ME0034499, and was so licensed at all times relevant to this case. At all times material to this case, Linda Wilson was not a licensed midwife and Dr. Sneij knew that she was not a licensed midwife. 3/ Mary Jones became pregnant for the third time in June or July of 1981. She went to see Dr. R. Strassberg, a specialist in obstetrics and gynecology, on July 24, 1981, and thereafter made regular visits to Dr. Strassberg's office until February 16, 1982. Mary Jones did not go back to Dr. Strassberg's office after February 16, 1982, because she had decided she wanted to deliver her baby at home. Jones did not tell Dr. Strassberg's office she was planning to have a home delivery; she simply never returned to Dr. Strassberg's office after the visit of February 16, 1982. During the time Jones was being attended by Dr. Strassberg there was nothing particularly remarkable about the course of her pregnancy other than a somewhat large amount of increase in her weight. Prior to her pregnancy in 1981, Mary Jones had given birth to two children, one in December of 1970 and the other in August of 1975. Both of the prior children were born in a hospital. During both of her prior pregnancies Mary Jones was attended by obstetricians. Mary Jones' first baby weighed eight pounds, twelve-and-a-half ounces, and was born breech. Her second baby weighed nine pounds, eight ounces, and was a normal birth. During the course of her 1981 pregnancy, Mary Jones became interested in home birth and began to go to some home birth classes, including some classes that were being taught by Linda Wilson. Jones decided that she wanted to have her baby delivered at home by a midwife and asked Linda Wilson about procuring the services of a midwife. Wilson was not doing home births at that time because Wilson was in nursing school, but Wilson recommended that Jones contact Margaret Hebson because Hebson had indicated an interest in providing midwife services for home births. Mary Jones first met with Margaret Hebson in January of 1982, at which time Mary was in the seventh month of her pregnancy. At their first meeting Hebson took a history, wrote down information about Jones' background, did an external examination which consisted of taking Jones' blood pressure and pulse, listening to the fetal heartbeat, and feeling the position of the baby. At that time Mary Jones hired Margaret Hebson to be her midwife. Jones paid Hebson $100.00 in advance and agreed to pay her an additional $200.00 after the birth. 4/ About three weeks later Hebson went to Mary Jones' house to do another examination. During that visit Hebson told Jones that Linda Wilson was also going to attend the birth and that Wilson would bring a doctor. Jones was uncertain about whether she wanted to have a doctor at the birth. Jones' uncertainty was due in large part to her very negative attitude towards doctors and hospitals as a result of her experiences during her two prior deliveries. She felt that doctors and hospitals made the birthing experience too impersonal and did not permit her to do things her way. She particularly wanted to be able to have the people of her choice in the birthing room and to hold her baby as soon as it was born; things which were denied her during her two prior deliveries which were at hospitals where she was attended by doctors. Mary Jones called Linda Wilson to discuss what Hebson had told her and Wilson told Jones that she could meet the doctor at Wilson's classes and then make up her mind. The doctor turned out to be Dr. Albert A. Sneij. Mary Jones first met Dr. Sneij during February of 1982, during her eighth month of pregnancy, after she had already made the decision to have a home birth and had already hired and paid a midwife. She met Dr. Sneij at one of the classes conducted by Linda Wilson. On the day she met Dr. Sneij, he took a prenatal history, did an external examination of her abdomen, and listened to the fetal heartbeat. On at least one subsequent occasion Dr. Sneij performed a similar abdominal examination and again listened to the fetal heartbeat. Mary Jones never retained the services of Dr. Sneij, never asked him to be her doctor, never agreed to be his patient, and never agreed to pay him anything for his services. No doctor-patient relationship was ever established between Dr. Sneij and Mary Jones. Mary Jones did not really want Dr. Sneij, or any other doctor, to be present at her delivery, but merely tolerated his presence because of her understanding that Linda Wilson wished to have Dr. Sneij present. 5/ As late as two days before her delivery, Mary Jones told Wilson and Hebson that she was not comfortable around Dr. Sneij and didn't know if she wanted him to attend her delivery. Wilson and Hebson told her she could wait until she was in labor to decide whether she wanted to have the doctor present at the delivery. Mary Jones' understanding of why Linda Wilson wanted the doctor present was that in the event Jones tore any tissues during the delivery the doctor would be there to suture her. Postpartum suturing was the only thing that Mary Jones even impliedly agreed to let Dr. Sneij do for her. Dr. Sneij did not have her consent, expressed or implied, to do anything else. Early in the morning on March 15, 1982, Mary Jones began to have contractions and to experience some pain. She got in touch with Hebson and ultimately around 9:00 or 9:30 a.m., Linda Wilson and Ricki Taylor 6/ arrived at the Jones residence. They checked Mary Jones and told her not to worry and to go on about her regular activities. Mary Jones spent the rest of the day doing such things as having lunch with her sister, going shopping, and then going for a walk around the block with her husband. Sometime before 5:00 p.m. that day Mary Jones called Hebson again. Hebson said she could not get off work until 5:00 p.m., but would get in touch with Wilson or Taylor and have one of them go out to the Jones residence. Sometime shortly before 5:00 p.m., Ricki Taylor arrived at the Jones residence. Then between 5:30 and 6:00 p.m. Louise Godwin, who is Mary Jones' sister and a registered nurse, arrived at the Jones residence. Margaret Hebson arrived about the same time as Godwin. Hebson did an internal examination of Mary Jones and told her that she was dilated four centimeters. Hebson also asked Jones various questions about what she had eaten that day and took her pulse and blood pressure. Linda Wilson did not arrive until sometime after 7:00 p.m. At that time Godwin was making supper and from then until about 9:30 p.m. everyone present attended to such things as domestic chores, eating supper, and/or trying to make Mary Jones more comfortable. At about 9:30 p.m., Wilson, Hebson, and Taylor decided to take Jones' two sons to the drug store for a few minutes. As they were leaving, Mary Jones' mother arrived. Wilson, Hebson, Taylor and the two boys returned about 40 minutes later. Nothing eventful happened until shortly before 11:00 p.m., at which time Jones' contractions started coming a lot closer together and Mary Jones suggested that someone start getting the bedroom ready for the delivery. Things were made ready, Wilson, Hebson, and Taylor changed clothes, and shortly after 11:00 a.m. Mary Jones was in the bedroom ready to begin trying to deliver her baby. It was probably at about this time that Linda Wilson called Dr. Sneij. 7/ Before Dr. Sneij arrived at the Jones residence, there were ten other people in the bedroom with Mary Jones; namely, Hebson, Wilson, Taylor, Godwin, Bob Jones (Mary's husband), both of the Jones sons, Mary's mother, and two of Mary's friends. Dr. Sneij arrived at the Jones residence shortly thereafter and remained in the living room for a few minutes until someone asked him to come into the bedroom. 8/ When Dr. Sneij entered the bedroom the baby's head was not yet visible. At that time Mary Jones had probably been in the second stage of labor for about twenty or thirty minutes. The baby's head was first visible about five or ten minutes after Dr. Sneij entered the bedroom. Thereafter the top of the baby's head was visible pressing against the peroneum for approximately thirty minutes until the baby's head was entirely delivered. Within a minute or two after the delivery of the baby's head, the baby was fully delivered. When the baby was born it had a blueish color and was not making any attempt to breathe. The baby was promptly suctioned and then Dr. Sneij and Louise Godwin administered mouth-to-mouth CPR to the baby. The baby's pulse was checked and found to be present. A few minutes later Fire Rescue was called. When the Fire Rescue personnel arrived, they took over the CPR efforts. At that time the baby still had a pulse and during the CPR efforts by Fire Rescue the baby's color improved. Fire Rescue transported the baby to James Archer Smith Hospital. The baby was still alive when the Fire Rescue personnel delivered the baby to the hospital. The baby died some time before noon on March 16, 1982. From the time Dr. Sneij entered the bedroom until the time the baby was delivered, Dr. Sneij was observing what was happening and Hebson was doing most of the "hands-on" work assisting Mary Jones with the delivery. Hebson was being assisted to some extent by Linda Wilson. Ricki Taylor appears to have been primarily an observer. Dr. Sneij was sufficiently attentive to what was happening to conclude that the delivery should probably be expedited and to recommend an episiotomy. When it was suggested that an episiotomy be done, Mary Jones protested against that suggestion and refused an episiotomy. During the second stage of labor the fetal heartbeat was checked at least once every fifteen minutes and the heartbeat was recorded on the midwife's notes on labor and delivery. 9/ The fetal heartbeat rate never indicated any fetal distress and the baby still had a pulse shortly after delivery. An autopsy of the Jones baby was performed by Dr. Charles V. Wetli, the Deputy Chief Medical Examiner for Dade County, Florida. The autopsy revealed no evidence of trauma and no evidence of any congenital diseases or abnormalities. The only findings were generalized visceral congestion and petechiae of the lungs and heart. These findings are indicative of a nonspecific form of an asphyxial mechanism of death. 10/ Dr. Wetli also examined the placenta. It appeared to be normal and contained no evidence of meconium staining. He also examined a section of the umbilical cord and found it to be normal. I have not made any findings of fact as to the level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under conditions and circumstances similar to those involved in this case because, for the reasons stated at length in the Conclusions of Law portion of this Recommended Order, there is no sufficiently substantial evidence in the record in this case a to the appropriate level of such care, skill, and treatment. 11/
Recommendation For all of the reasons stated above, I recommend that the Board of Medical Examiners enter a Final Order in this case which DISMISSES the entire Administrative Complaint against Dr. Sneij. DONE and ORDERED this 9th day of November, 1984, at Tallahassee, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of November, 1984.
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.
Findings Of Fact Based upon all of the evidence, including the pleadings and stipulated record, the following findings of fact are determined: On November 7, 1989, the Department of Professional Regulation (DPR) received a copy of a Serious Incident Report (SIR) prepared by Alachua General Hospital in Gainesville, Florida. The SIR was filed pursuant to law and indicated that a newborn infant baby had died at the hospital on September 16, 1989, while under the care of petitioner, Thomas B. B. Benton, a licensed medical doctor and pediatrician. After the SIR was received, a DPR investigator conducted an investigation of the incident, including interviews with petitioner, six involved nurses, the obstretrician at delivery, and the pediatrician who responded to the emergency code at the hospital. The investigator also obtained the medical records of the mother and baby. On February 22, 1990, a one hundred seventeen page investigative report, consisting of the investigator's notes, medical records, SIR, and other related information, was issued. A copy of the investigative report was given to a board certified pediatrician on August 24, 1990, who reviewed the report and records with a focus on petitioner's care and treatment of his patient. The consulting physician was asked to answer nine specific questions, including whether petitioner prepared and kept written medical records justifying the course of treatment of the patient and whether petitioner met the applicable standard of care in his examination, diagnosis and treatment of the patient. Also asked were questions pertaining to whether petitioner had adquately assessed the patient's condition, whether it was inappropriate to place the patient in the regular nursery without a monitor, and whether it was inappropriate for petitioner to not inform the on-call doctor of the patient's condition. In response to this charge, the consultant prepared a twelve page analysis of the case with responses to each of the nine questions. The analysis contained an ultimate conclusion that petitioner had failed to meet the applicable standard of care with regard to his diagnosis and treatment of the baby and, with respect to the adequacy of his records, petitioner had failed to document his medical records with a definitive treatment plan and with reasons for not ordering certain tests on the infant. The investigative report and consultant's analysis were given to a probable cause panel on January 28, 1991. The panel was composed of two doctors and a lay person, all members of respondent, Board of Medicine (Board). After a discussion of the report and analysis, which the record shows was a meaningful inquiry, the panel found, by a 2-1 vote, probable cause that a violation of Subsections 458.331(1)(m) and (t), Florida Statutes, had occurred. Those subsections impose requirements that a physician keep adequate written medical records and adhere to the appropriate standard of care. The panel also recommended that DPR issue an administrative complaint. It is noted that the two panel members voting in favor of prosecution expressly relied on the consultant's report. On February 6, 1991, a two-count administrative complaint was issued by DPR alleging that petitioner had violated subsections 458.331(1)(m) and (t) in several respects. As to subsection 458.331(1)(m), the complaint alleged he had failed to document his reasons for not ordering a cardiac/apnea monitor, had failed to document his reasons for not ordering studies to assess the patient for the possibility of sepsis, and had failed to document a definitive plan of treatment. As to subsection 458.331(1)(t), it need only be said that the complaint alleged generally that petitioner failed to adhere to the standard of care while treating the infant. After petitioner requested a formal hearing to contest the charges, the complaint was forwarded to the Division of Administrative Hearings and was assigned Case No. 91-2367. Several months prior to hearing, DPR amended its first count in the complaint to delete the two allegations that respondent failed to document reasons for not ordering certain tests. In lieu thereof, it added an allegation that there was a contradiction between petitioner's recorded plans to closely monitor the infant and his subsequent conduct, an allegation also based on an alleged violation of subsection 458.331(1)(m). This amendment was made after petitioner had filed a motion to compel discovery seeking the basis for the two factual allegations and whether they contravened the holding in Breesmen v. Department of Professional Regulation, 567 So.2d 469 (Fla. 1st DCA 1990). Conceding as much that they did, the Board thereafter filed an amended complaint. Because the Board was a party to that case, and the issuance of the opinion predated the panel's meeting, it must be assumed that the panel and its counsel were aware, or should have been aware, of the case's holding when the matter was considered. Therefore, the Board's decision to bring the two deleted charges in Count I was not substantially justified. After an evidentiary hearing was conducted, a recommended order was issued on November 7, 1991, recommending that the complaint be dismissed with prejudice. This recommendation was adopted in toto by the Board and a final order dismissing the complaint was issued on February 25, 1992. The recommended and final orders are reported in Department of Professional Regulation v. Benton, 14 F.A.L.R. 1924 (Board of Medicine, February 22, 1992). Because no appeal was taken, the Board's order is now final. Petitioner contends that the consultant's analysis is at odds with the information available to the probable cause panel and thus the panel's reliance on the analysis resulted in a flawed decision to prosecute. More specifically, petitioner focused on that part of the analysis which concluded that he failed to perform certain follow-up tests on the patient, failed to place the patient on a monitor or under closer supervision in the nursery, and failed to inform the on-call physician about the patient's medical problems. All relate to the general charge in Count II that he failed to conform to the appropriate standard of care. To support her conclusion that petitioner failed to perform certain follow-up tests, the consultant noted that at the time of birth, the patient's mother had had a fever for several days and the infant was at risk for sepsis (infection), the infant had known neurologic abnormalities, the mother had experienced placental abruption and thus the child may have had anemia, and the child was at risk for respiratory problems from possible meconium aspiration. Although the medical records showed that the mother's fever had actually subsided before the C-section was performed, the mother had experienced fever for several days just prior to the date of delivery and was on antibiotics. The records also reflected that the child had neurologic abnormalities, meconium staining was present at birth, and the mother had a partial placental abruption during delivery. Therefore, the consultant's analysis as to this allegation was substantially in accord with the medical records, and the panel had a reasonable basis in fact to bring this charge. The complaint also alleged that petitioner failed to adequately monitor the baby after it was placed in the nursery. This allegation was drawn from a recommendation by the consultant, whose conclusions were based on two considerations. First, the infant had known neurologic abnormalities and other risk factors, as discussed in the previous finding. Second, the consultant opined that the regular nursery was a "busy nursery", the nurses did not have "many years of nursing experience", and "all worked (in the newborn nursery) less than one year". The latter opinion was predicated on certain investigative notes and the consultant's review of statements made by six nurses. Petitioner asserts that because the investigator failed to record the work experience of a senior nurse and failed to interview two nurses who were on duty in the nursery the night of the infant's death, and the consultant failed to note that several of the nurses had been licensed for more than two years, the recommendation was flawed. However, it is noted that the consultant did not rely exclusively on the purported lack of experience on the part of the nursing staff in reaching her conclusion but placed equal reliance on the notion that the baby's history and risks warranted giving the baby special post-delivery supervision. Therefore, the report contains a factual basis to support the consultant's conclusion and thus the panel had a reasonable basis in fact to bring this charge. Petitioner next contends that the recommendation to charge him with failing to adhere to the standard of care because of his failure to inform the on-call physician about the patient's condition and history was likewise at odds with the real facts. In making this argument, he points to findings in the recommended order which found in favor of petitioner on this issue and to that portion of the baby's medical records which recorded his condition while in the nursery. Again, however, the consultant reached this conclusion based on the baby's "history and status", and thus she had a factual basis to support her opinion. Therefore, the panel's decision to prosecute this alleged breach of care was substantially justified. The parties have stipulated that petitioner is a small business party as defined by Subsection 57.111(3)(d), Florida Statutes, he was the prevailing party in the underlying disciplinary action, his attorney's fees and costs incurred in defending against the action are reasonable but are limited to the statutory cap of $15,000, and at least $4,000 was incurred in defending Count I while at least $15,000 was incurred in defending Count II. They have further agreed that there are no special circumstances that would make an award of attorney's fees and costs unjust.
The Issue At issue in this proceeding is whether Respondent, Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care (“Bread & Roses”), provided services in excess of the scope of its license by providing abortions to five patients beyond the first trimester of pregnancy, as alleged in the Administrative Complaint.
Findings Of Fact Based on the oral and documentary evidence adduced at the final hearing, and the entire record in this proceeding, the following Findings of Fact are made: AHCA is the state agency responsible for the licensing of abortion clinics and the enforcement of the statutes and rules governing their operations in Florida, pursuant to chapter 390 and chapter 408, part II, Florida Statutes. Bread & Roses is a women’s health care clinic licensed to provide first-trimester abortions pursuant to chapter 390, Florida Statutes, and Florida Administrative Code Chapter 59A-9. Kimberly Smoak is AHCA’s field office supervisor. She is based in Tallahassee and supervises the operations of AHCA’s field offices throughout the state. Kriste Mennella is an AHCA field office manager based in Alachua, who reports directly to Ms. Smoak. On or about August 5, 2015, Ms. Smoak directed Ms. Mennella’s office to conduct an unannounced “monitoring” survey of Bread & Roses and to send Ms. Smoak her survey report before the end of the day. Ms. Mennella personally conducted the survey. Ms. Mennella arrived at Bread & Roses at 12:45 p.m. on August 5, 2015, to conduct the survey. She requested and reviewed utilization reports and medical records for 16 patients for whom Bread & Roses had provided abortion services within the previous year. Section 390.0112(1) provides the following reporting requirement: The director of any medical facility in which any pregnancy is terminated shall submit a monthly report to the agency which contains the number of procedures performed, the reason for same, the period of gestation at the time such procedures were performed, and the number of infants born alive during or immediately after an attempted abortion. The agency shall be responsible for keeping such reports in a central place from which statistical data and analysis can be made. (Emphasis added). Chapter 390 does not define the terms “gestation” or “pregnancy.” Section 390.011(11) defines “third trimester” to mean “the weeks of pregnancy after the 24th week of pregnancy.” From this definition, it is possible to infer that the first trimester includes the first 12 weeks of pregnancy and that the second trimester includes the second 12 weeks of pregnancy. Consistent with this inferred definition, rule 59A- 9.019(14) provides as follows: (14) “Trimester” means a 12-week period of pregnancy. First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period). Second Trimester. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation. Third Trimester. That portion of pregnancy beginning with the 25th week of gestation. (Emphasis added). Ms. Mennella found the following in the clinic’s utilization reports for five of the 16 patients in the survey sample: Patient #5: no last normal menstrual period (“LNMP”) recorded; ultrasound reflected 13 weeks of pregnancy. Patient #7: no LNMP recorded; ultrasound reflected 13.2 weeks1/ of pregnancy. Patient #8: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. Patient #9: no LNMP recorded; ultrasound reflected 13 weeks of pregnancy. Patient #15: no LNMP recorded; ultrasound reflected 13.4 weeks of pregnancy. During the survey, the clinic manager for Bread & Roses, who prepares the clinic’s utilization reports, explained to Ms. Mennella that the “weeks” reflected on Bread & Roses’ utilization reports reflected the length of pregnancy as counted from the first day of the LNMP. Therefore, all five of the patients’ abortions were within the 14-week window afforded by rule 59A-9.019(14)(a). Ms. Mennella documented her conversation with the clinic manager in her formal survey notes and in her August 5, 2015, formal survey report to Ms. Smoak. At the conclusion of the survey, Ms. Mennella reported to Ms. Smoak by telephone, though Ms. Mennella testified that she could not recall the details of the discussion. At 4:50 p.m. on August 5, Ms. Mennella telephoned Kristin Davy, the owner and director of Bread & Roses. Ms. Mennella told Ms. Davy that AHCA had determined that Bread & Roses had acted in violation of its license by performing second-trimester abortions, based on the clinic’s utilization reports and the medical records reviewed by Ms. Mennella during the on-site survey. Ms. Davy replied that AHCA’s conclusion was incorrect because the weeks and days recorded on the ultrasound reports measured from the first day of the LNMP, meaning that all five of the questioned procedures had been performed within the first trimester of pregnancy. After her discussion with Ms. Davy, Ms. Mennella submitted her formal survey report to Ms. Smoak. Ms. Mennella’s survey notes and her survey report to Ms. Smoak each documented Ms. Davy’s dispute of AHCA’s conclusion and her explanation of the ultrasound reports. At 6:15 p.m. on August 5, Ms. Mennella faxed a letter to Ms. Davy with the heading, “Notice of Activity Without Proper Licensure.” The letter stated that AHCA had determined that Bread & Roses was providing services beyond the scope of its license. The letter did not attach a copy of Ms. Mennella’s survey report nor any other document reflecting the specifics of AHCA’s allegations regarding the clinic’s operation. Ms. Mennella made a follow-up visit to Bread & Roses on August 19 to determine whether there had been any more procedures performed that appeared to be beyond the scope of the clinic’s license. Based on her review of the clinic’s files, she determined that there had not. On September 1, 2015, AHCA faxed to Bread & Roses a letter signed by Ms. Mennella reporting the findings of its survey and requiring the facility to file a corrective action plan. The letter was accompanied by a statement of deficiencies recorded during Ms. Mennella’s August 5 survey. The statement of deficiencies stated that Bread & Roses had performed services beyond the scope of its license as follows: For sampled patients #5, #7, #8, #9 and #15, no date was recorded for the last normal menstrual period (LMP); however, the ultrasound reflected weeks of gestation in excess of 12 as documented in the patients’ records. Ms. Mennella’s documentation of her conversations with the office manager and Ms. Davy were excised from the version of the survey report faxed to Bread & Roses on September 1, 2015. Ms. Mennella had no explanation for this deletion, and testified that she could not recall whether she told Ms. Smoak about the explanations offered by the office manager and Ms. Davy as to the meaning of the ultrasound reports. Ms. Mennella’s letter of September 1 directed Bread & Roses to submit a written corrective action plan to AHCA by the close of business on September 4, 2015. The letter stated that the corrective action plan must do the following, at a minimum: * Demonstrate procedures are in place to ensure that first trimester abortions are not performed: In excess of 14 weeks (up to but not including the 105th day) from the last normal menstrual period (LNMP), and in excess of the 12th week (up to but not including the 91st day) of gestation; or When LNMP is not determined or not documented, abortions are not performed beyond the 12th week (up to but not including the 91st day) of gestation. * Educate staff to ensure that when reporting pursuant to rule 59A-9.034, F.A.C., on the online reporting system, that the field titled “WEEKS OF GESTATION” is correctly completed using “weeks of gestation” as that phrase is used in rule 59A-9.019, F.A.C., and not erroneously using the last normal menstrual period. On September 3, 2015, one day prior to expiration of the deadline for submission of Bread & Roses’ corrective action plan, AHCA filed the Administrative Complaint that initiated this proceeding. The Administrative Complaint seeks to impose an administrative fine of $2,500 on Bread & Roses, or $500 for each instance in which AHCA alleges that the clinic performed an abortion during the second trimester, beyond the scope of its license. Bread & Roses submitted a responsive letter to AHCA shortly after 1:00 p.m. on September 4, 2015. The letter, written and signed by Ms. Davy, stated as follows, in relevant part: This letter responds to your letter dated September 1, 2015, which requested a summary of a corrective action plan demonstrating two things: First, that procedures are in place to ensure that first trimester abortions are not performed in excess of 14 weeks from the last normal menstrual period (LNMP), and Second, that staff are educated to report “WEEKS OF GESTATION”--in the monthly online ITOP reports, filed pursuant to rule 59A- 9.034, F.A.C.--“using ‘weeks of gestation’ as that phrase is used in rule 59A-9.019, F.A.C.,” and not using LNMP. As to the first requirement, Bread & Roses has always provided abortion care only through and including 13.6 weeks LNMP, or 13 completed weeks and 6 days as measured from LNMP. Our staff records the date that the woman remembers for her LNMP if and only if she remembers such a date (and if she had such a date: some women do not menstruate, such as when using certain contraceptives). If the woman did not have or does not remember the date of her LNMP, we do not include such a date in her record. Regardless of whether she remembers such a date, we do not determine the length of her pregnancy based on that memory. Rather, in accordance with the standard of care, we determine the length of her pregnancy based on ultrasound examinations. Please be aware that--again, as is absolutely standard practice throughout Florida and the U.S.--our ultrasound machine provides a length of pregnancy as measured from LNMP. In other words, based on the measurements of the embryo or fetus, the ultrasound machine produces an estimated length of pregnancy as measured from LNMP. Our corrective plan of action is to ensure that henceforth, in all medical records, all staff include “LMP” [sic] after each indication of length of pregnancy, including when staff record the results of an ultrasound examination. As to the second requirement, for clarity, here is the relevant regulation: “First Trimester. The first 12 weeks of pregnancy (the first 14 completed weeks from the last normal menstrual period).” 59A-9.019(14)(a), F.A.C. Based on your letter dated September 1, 2015, all staff will now report “WEEKS OF GESTATION” in the monthly online [Induced Termination of Pregnancy or “ITOP”] reports using “weeks of gestation” as measured not from LNMP, but from two weeks after LNMP. In other words, we will henceforth report an abortion at 13.1 weeks LNMP as an abortion at 11.1 weeks in the online field for “WEEKS OF GESTATION.” The ITOP form referenced in the letter is a monthly summary report filed by the clinic with AHCA regarding the timing of the abortion procedures performed at the clinic. Printed examples of the forms were submitted into evidence by AHCA. The form sets forth three reporting categories: “up to 12 weeks,” “13 to 24 weeks,” and “25 and over weeks.” The form, at least in the printed version submitted by AHCA, uses neither the term “pregnancy” nor “gestation.” At the hearing, Ms. Davy testified that she wrote the corrective action plan to ensure there would be no more misunderstanding about what Bread & Roses was doing. She was adamant that Bread & Roses was not performing second-trimester abortions. She stated that the clinic was not changing its medical standards, but was clarifying its reports to AHCA. From that point forward, Bread & Roses would include “LNMP” after every notation of length of pregnancy in its medical records, and its ITOP reports to AHCA would subtract the two-week LNMP interval. Ms. Davy testified that the corrective action plan was implemented on the day it was submitted to AHCA. Ms. Davy further testified that Bread & Roses had been submitting its reports to AHCA in the same manner for the ten years in which it has restricted its license to first- trimester abortions. She had always understood that “weeks of gestation” on the ITOP form was meant to be dated from the first day of the last normal menstrual period, which is standard industry practice. No other surveyor ever told her that she was filling the forms out incorrectly or had attempted to infer that the clinic was operating beyond the scope of its license. AHCA’s most recent routine survey of Bread & Roses, prior to the August 5 survey, had been performed on February 14, 2015. No deficiencies had been found. AHCA presented no evidence to counter Ms. Davy’s credible testimony that Bread & Roses had been submitting its ITOP reports in the same manner for the previous ten years without incident. AHCA presented no evidence to explain why it suddenly believed that Bread & Roses’ ITOP reports showed that the clinic was performing second-trimester abortions. Ms. Davy testified that Bread & Roses does not rely on a patient’s reported LNMP to measure length of pregnancy because such reports are inherently unreliable. Thus, whether or not a patient’s medical record includes a patient-reported LNMP is of no importance to the length of pregnancy reported on the ITOP. In all cases, Bread & Roses reports length of pregnancy as measured by the ultrasound machine. Bread & Roses owns the ultrasound machine used in its clinic. Ms. Davy testified that she had the machine calibrated at the time of purchase, about a year and a half ago. The machine is checked annually by North Florida Biomedical Services. Bread & Roses’ written policies and procedures include the following, under the heading “Sonography”: A sonogram will be performed on all patients. Bread and Roses performs abortion procedures in the first trimester, up to 13 weeks 6 days from the last menstrual period. A sonogram will determine how many weeks the patient is from the last menstrual period. If a patient is 14 weeks or over she will be referred to an alternate clinic. Mary E. Raum, M.D., is a gynecologist and has been the medical director at Bread & Roses for 15 years. She has practiced gynecology since 1983. Dr. Raum performs all of the ultrasound and abortion procedures done at Bread & Roses. She performed the ultrasound procedures on each of the five patients at issue in this case. Dr. Raum testified that the “ultimate determinant” as to whether a patient is in the first or second trimester is the ultrasound. She stated that the ultrasound is “definitive” and has become the standard of care for assessing the length of pregnancy. Dr. Raum testified that the ultrasound equipment she was using met standards for such equipment. She had no doubt that the equipment was functioning properly. AHCA offered no evidence to dispute Dr. Raum’s assessment of the ultrasound equipment. Dr. Raum described her manner of performing the ultrasound procedure as follows: The patient is laying [sic] flat. I always hope that I can get an adequate image abdominally so the patient doesn’t have to have a vaginal probe. But there are times when that is necessary. The abdomen is spread with the ultrasonic gel, and then the probe, which is called a transducer--that is what actually emits the sound waves which are higher than the human ear can hear . . . . [A]s soon as I see what I feel to be a good representative picture where I can measure the pertinent structures, it’s frozen, and then I select, on the possible measurements, the appropriate one. Early on, the most appropriate ones are either the gestational sac or the crown-rump length, which is measured from the top of the head to the end of the tailbone, if you will. There is an algorithm that is programmed into the ultrasound machines which then translates those two measurements into the date of the pregnancy from the first day of the last menstrual period. Dr. Raum testified as to the care she takes in performing the ultrasound measurement. If she is uncertain, she will take several measurements until she has the most accurate possible measurement. Dr. Raum frankly tells her patients that if the measurement is even one day beyond the 14-week limit, she will not perform the abortion. AHCA did not call any witness to explain the basis for the Administrative Complaint. The facts alleged are that the medical records for the five patients at issue do not contain an LNMP date, and that the sonogram in the medical record of each of the five patients reflects “weeks of gestation in excess of 12.” AHCA presented no evidence in support of its allegation concerning the length of gestation. It might have been reasonable at the time of Ms. Mennella’s survey for the agency to read the ITOP reports and the patient records and suspect a problem. However, it was not reasonable for the agency to disregard the reasonable explanations provided by the Bread & Roses office manager and by Ms. Davy. Ms. Mennella herself could not say why AHCA decided to file an administrative complaint alleging that Bread & Roses performed five second-trimester abortions, or why her documentation of her conversations with the office manager and Ms. Davy were excised from the final version of her survey report. AHCA’s theory of the case appears to be that the lack of a handwritten notation of “LNMP” in the five medical records at issue requires a conclusion that the days and weeks shown on the face of the sonogram reflect a length of pregnancy as measured from the date of “conception” or “gestation,” rather than the LNMP. This premise is unfounded, and the failure of the premise destroys the logic of AHCA’s theory. The ultrasound measures the same thing, whether or not the medical record contains a patient-reported LNMP date. The evidence presented at the hearing showed that the ultrasound dates the pregnancy from the LNMP, and that Bread & Roses’ ITOP reports were based on the ultrasound results. The missing LNMP notes are a red herring. AHCA’s case consisted largely of an argument premised on applying the dictionary definition of the term “gestation” to the medical records of Bread & Roses, which do contain a “Patient Procedure Record” that makes reference to “gestation” in the section regarding the physician’s examination of the evacuated tissue post-abortion. Indeed, if these abortions had been performed after 13 weeks of “gestation,” as that term is defined in some medical dictionaries,2/ then they would have been beyond the first trimester. However, Ms. Davy testified that, consistent with standard medical practice, the term “gestation” on the Patient Procedure Record means, and has always meant, length of pregnancy as measured from the first day of the LNMP. Ms. Davy stated that she has amended the Patient Procedure Record to add “LNMP” after every indication of length of pregnancy, in order to prevent any future misunderstandings. Dr. Raum testified that medical practitioners generally do not attempt to measure the length of pregnancy from the date of conception because that date is difficult, if not impossible, to determine in an accurate and reliable fashion, except perhaps in cases of in vitro fertilization. AHCA’s own rule appears to recognize this difficulty by defining the “first 12 weeks of pregnancy” as equivalent to the “first 14 completed weeks from the last normal menstrual period.” In light of the overwhelming factual evidence that Bread & Roses did not in fact perform second trimester abortions, the dictionary definition of “gestation” was an insufficient basis for finding a violation. AHCA made no attempt at a factual, as opposed to a logical, demonstration that these were second-trimester abortions. AHCA presented no testimony or documentary evidence refuting the credible evidence presented by Bread & Roses that the sonograms show on their face that the pregnancies for each of the five procedures at issue were first trimester pregnancies and within the scope of Bread & Roses’ license. AHCA has argued that it should be allowed to show, in the alternative, that Bread & Roses’ clinical records were not accurately documented because they showed more than 12 weeks of “gestation” for each of the five sampled patients, in both the sonograms and the Patient Procedure Record, in violation of rule 59A-9.031, which requires that clinical records must be “complete” and “accurately documented.” It is noted that, prior to the hearing, AHCA made a motion to file an Amended Administrative Complaint that would have included a second count alleging a recordkeeping violation. This motion was denied by Order dated February 26, 2016. At the start of the final hearing, AHCA renewed its motion while also arguing that it was not necessary to amend the Administrative Complaint in order to raise the recordkeeping issue. The motion was again denied, but AHCA was given some leeway to pursue its theory that the original Administrative Complaint embraced a recordkeeping allegation. Even if the Administrative Complaint could be said to include an allegation regarding inaccurate recordkeeping,3/ AHCA did not prove anything more than that it misread the clinical records and ITOP reports of Bread & Roses and then refused to listen to Bread & Roses’ explanation. The evidence established that Bread & Roses had submitted the ITOP forms to AHCA every month for ten years in substantially the same form with no indication from AHCA that there was a problem. The evidence also established that the term “gestation” in the Patient Procedure Records was used in its usual medical sense, i.e., the length of pregnancy as measured from the first day of the LNMP. Bread & Roses amended its Patient Procedure Record form and changed its method of reporting the ITOP not because of any recordkeeping failure on its part, but in an effort to appease AHCA and forestall any further misunderstanding.
Recommendation Based on the foregoing, it is, therefore, RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the Administrative Complaint against Gainesville Woman Care, LLC, d/b/a Bread & Roses Well Woman Care. DONE AND ENTERED this 28th day of April, 2016, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON 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 28th day of April, 2016.
The Issue Whether Respondent, an abortion clinic, failed to maintain emergency medications and related supplies in violation of Florida Administrative Code Rule 59A-9.0225(1) and the penalty, if any, that should be imposed.
Findings Of Fact At all times relevant to this proceeding, Respondent has been licensed as an abortion clinic authorized to perform first and second trimester abortions. The facility at issue in this proceeding is located in North Miami Beach, Florida. Ms. Ody conducted an unannounced inspection of the subject facility on April 21, 2011. Ms. Herne was the only other person at the facility during the inspection. Ms. Ody determined that medications inside an orange box located in the subject facility that served as a crash cart included emergency medications that were out-of-date. Those medications were one 500-ml bag of Lactated Ringer's Intravenous Solution (expired April 2009), a one-mg vial of Atropine (expired November 2010), and one 2 percent Llidocaine Hydrochloride injection (expired November 2010). The crash cart belonged to a certified registered nurse anesthetist, who had worked at the facility at one time. That person had not worked at the facility for several years, and had not returned to claim her property. Dr. Rosenthal's efforts to contact that person were unsuccessful. Dr. Rosenthal and Ms. Herne testified, credibly, that they considered the contents of the crash cart to be that of the former employee and they had never used or attempted to use the contents of the crash cart. On April 21, 2011, the facility had no surgical procedures planned, and no patients were present. On September 12, 2011, Ms. Ody and Ms. Render inspected the subject facility. Ms. Herne was the only other person present during the inspection. During the course of their inspection, they found three bottles of antiseptic located inside of a cabinet in the facility's operating room. Each bottle contained the name Humco Strong Iodine. Two of the bottles of iodine expired in August 1995 and the third bottle expired in May 2005. The three bottles of iodine were not used for surgical procedures. The testimony of Ms. Herne and Dr. Rosenthal established that the iodine was used solely to reduce the odor of infectious waste, which was put in a small container in the operating room until it could be transferred to a larger container in an adjacent room. On September 12, 2011, the facility had no surgical procedures planned, and no patients were present. Petitioner failed to prove that the subject facility did not have appropriate emergency medications or supplies on either of the inspection dates.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Agency for Health Care Administration enter a final order dismissing the charges against A Medical Office for Women, Incorporated, d/b/a Medical Office for Women set forth in its Administrative Complaint. DONE AND ENTERED this 31st day of July, 2012, in Tallahassee, Leon County, Florida. S CLAUDE B. ARRINGTON Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 2012.
