The Issue The issue for determination is whether Respondent’s rule is an invalid exercise of delegated legislative authority, and/or whether Respondent’s agency statement constitutes a rule and has not been adopted pursuant to the statutory rulemaking procedure.
Findings Of Fact Several children attending schools in the Broward County School Board’s (Respondent’s) district require the performing of medical procedures, among them daily catheterization, also referred to as intermittent urinary catheterization or clean intermittent catheterization, using the clean technique. 2/ Respondent ensures that such medical needs of each student are met. Catheterization (clean intermittent catheterization) is an invasive medical procedure. An invasive medical procedure is a medical procedure that invades or goes within a body orifice or opening for the purpose of providing care for the infirm, the promotion of wellness, maintenance of health, and/or prevention of illness. Catheterization involves the insertion of a tube into a student’s bladder through the urethral opening for the purpose of eliminating urine from the student’s body. Respondent's teacher aides and teacher assistants are paraprofessionals. They are primarily designated to specifically meet the needs of those students who require daily catheterization. For more than 15 years, Respondent has continuously engaged in a practice of using paraprofessionals to provide health-related services, including catheterization. Such practice by Respondent is a policy of Respondent. Respondent’s principals assign paraprofessionals to catheterize students, who have a disability or infirmity, and cannot deviate from this practice without the approval from the Area Superintendent. Principals are permitted to use licensed nursing personnel to catheterize students only when the principals receive approval from the Area Superintendent. Respondent has a standard procedure, even though there are no written guidelines, for servicing students who need catheterization because of disability or infirmity. The standard procedure is compulsory and each principal must adhere to it. The following process comprises this standard procedure: The medical situation of the student with a disability or infirmity must be reviewed by an Individual Educational Plan (IEP) committee. The IEP committee determines what services the student needs. If the IEP committee determines that a student requires catheterization, the principal selects a paraprofessional from the school’s staff and assigns that paraprofessional to perform the catheterization. If no paraprofessional is available, the principal declares a vacancy and advertises the vacancy. Until a paraprofessional is hired to fill the position, the School Board contracts with an outside agency to have a licensed nurse provide the service. In advertising for the paraprofessional vacancy, the principal specifies on the job listing that the applicant must be willing to accept the responsibility to provide individual care for the student, including daily catheterization. The applicant’s willingness to catheterize the student is a condition of hiring and of continued employment. When the paraprofessional is identified, the paraprofessional is given child-specific training. The training usually takes approximately two hours and is required to catheterize a student without direct supervision. (The training is provided primarily to show the individual paraprofessional the proper technique based on the child’s specific condition.) Cassandra Bennett (Petitioner Bennett) is a teacher aide employed by Respondent at Thurgood Marshall Elementary School (Thurgood Marshall). Broward Paraprofessional Association (PPA) is the certified bargaining representative for teacher aides employed by Respondent. Petitioner Bennett is a member of the PPA. Petitioner Bennett received child-specific training. The principal at Thurgood Marshall assigned duties to Petitioner Bennett, which included, but were not limited to, catheterizing a student at Thurgood Marshall. Petitioner Bennett did not feel comfortable catheterizing the student because she believed that catheterization was a medical procedure which required a licensed individual, which she was not. Petitioner Bennett notified her principal of her position. Regardless, the principal at Thurgood Marshall required Petitioner Bennett to catheterize the student. Petitioner Bennett complied with the principal’s directive because Petitioner Bennett believed that a refusal to perform the catheterization would result in the loss of her job. Respondent assured PPA that no paraprofessional would be forced to perform catheterization on a student. Moreover, Respondent assured PPA that, if a paraprofessional refused to attend training or to perform a catheterization, no disciplinary action would be taken against the paraprofessional. After being contacted by the PPA regarding Petitioner Bennett’s situation, Respondent notified the principal at Thurgood Marshall, by memorandum dated October 23, 1997, that no paraprofessional, including Petitioner Bennett, could be forced or required to perform catheterizations, but that paraprofessionals could only volunteer to perform catheterizations. Thereafter, Petitioner Bennett was notified that she was not required, and would no longer be required, to perform catheterization. Respondent employs a Clinical Nursing Supervisor, Marcia Bynoe, who is responsible for the paraprofessional training program. She has been a practicing nurse for over 20 years and has been a nursing school instructor. Ms. Bynoe is unaware of any other situation, besides the case at hand, wherein non-medical professionals are given catheterization training with the expectation that they will perform the medical procedure in the course of their employment. Paraprofessionals were and are utilized by Respondent for the catheterization of a student with a physical disability or infirmity as follows: To administer the treatment to the student to maintain the student’s health as directed by the School Board’s [Respondent’s] principal at Thurgood Marshall Elementary School, with the approval of Ms. Bynoe, and the School Board’s [Respondent’s] Coordinator of Health Education Services (who is also a registered nurse). To observe and evaluate the student’s physical condition, behaviors, signs and symptoms of illness associated with the catheterization and reactions to the treatment; and to make a determination as to whether such conditions, behaviors, signs, symptoms and reactions represent a deviation from what is considered normal. Paraprofessionals were trained and [Petitioner] Bennett was instructed to observe the student, measure the quantity of urine, and to look for signs of cloudiness, blood, mucus, strong or unusual odor, or other signs of trauma or infection. The paraprofessionals administer the treatment, including catheterization, with the approval of Respondent’s nurse. Periodic monitoring of the treatment being provided to the disabled students is conducted by Respondent’s nurse. Catheters that are used to catheterize the students are reusable. The catheters must, therefore, be washed and put away after each use in accordance with the training provided by Respondent. Paraprofessionals come in contact with body fluids due to catheterizing a student on a daily basis. Failure of a paraprofessional, because of lack of knowledge, training, or experience, to follow universal safety precautions or dispose of waste properly in performing the catheterization of a student who may have a contagious or infectious disease, can cause a life- threatening risk of contamination to other staff members, other students, the paraprofessional’s family, and the general public at large. Respondent is not aware of any other setting where unlicensed persons, other than the patient’s family members or the patients themselves, are trained to perform medical procedures like catheterization with the expectation that the unlicensed persons will be permitted to perform invasive medical procedures. Respondent’s non-medical personnel are not even permitted to give students injections. Some paraprofessionals are designated as surplus or excess and are placed on a surplus or excess list. Respondent’s representative who is responsible for the surplus or excess list of paraprofessionals requires these paraprofessionals to perform catheterization, if needed, in order to work. A list of vacancies is forwarded by Respondent to these paraprofessionals. The list of vacancies may contain positions which require a paraprofessional to perform catheterization. The excess paraprofessional must choose one of the listed positions, even a position that requires catheterization, or face termination. This requirement is contrary to Respondent’s pronounced position of not requiring paraprofessionals to perform catheterizations but making catheterization a voluntary act on the part of paraprofessionals. At some of Respondent’s school sites, paraprofessionals and other non-medical personnel are also being permitted or allowed to provide catheterization or supervise self- catheterization for students who have physical disabilities or infirmities. Paraprofessionals and the other non-medical personnel are monitored periodically by a nurse. Respondent has a policy, which includes its standard procedure, of utilizing paraprofessionals to catheterize students who have physical disabilities or infirmities. Respondent’s policy substantially affects its paraprofessionals, who are PPA members, at Respondent’s school sites attended by students, whose physical disability or infirmity requires catheterization. Respondent’s policy also substantially affects the special-needs children, themselves, and their parents. Chapter 232, Florida Statutes, is applicable to the case at hand. During the 1996 Legislative Session, the Florida Legislature passed an amendment to Chapter 232, by way of Committee Substitute for House Bill 483 (CS/HB 483), which became law without the governor’s signature and which took effect on July 1, 1996. The amendment is found at Chapter 96-294, Laws of Florida, and embodied in Florida Statutes at Section 232.465. The Final Bill Analysis for CS/HB 483 states, in pertinent part, as follows: SUMMARY: * * * [The bill] also prohibits certain medical services by nonmedical school district personnel in order to ensure that such nonmedical school district personnel are properly trained in the administration of medication and that these personnel refrain from performing invasive procedures. Invasive procedures include, but are not limited to: cleaning intermittent catheterization; providing sterile catheterization; cleaning and maintaining a tracheostomy; providing gastrostomy tube feeding; monitoring blood glucose; and administering injectable medications. SUBSTANTIVE ANALYSIS: PRESENT SITUATION: * * * In many situations, teachers are administering medical procedures, and there is a feeling that this goes beyond their "scope of academics" [sic]. Many instances exist where there are special needs children, requiring such procedures as catheterization, gastrostomy tube feeding (inserting tubes for feeding into the stomach), and the injection of medications. EFFECT OF PROPOSED CHANGES: The bill requires school district nonmedical personnel who administer prescribed medication to be trained by medical personnel. It also requires review of cases in which medications are administered and prohibits nonmedical personnel from performing invasive medical services such as cleaning intermittent catheterization, providing sterile catheterization, cleaning and maintaining a tracheostomy; providing gastrostomy tube feeding; monitoring blood glucose; and administering injectable medications. * * * SECTION-BY-SECTION ANALYSIS: * * * Section 2. Creates s. 232.465, F.S., to indicate that nonmedical school district personnel shall not be permitted to perform invasive medical services, including, but not limited to, cleaning intermittent catheterization; providing sterile catheterization; cleaning and maintaining a tracheostomy; providing gastrostomy tube feeding; monitoring blood glucose; and administering injectable medications. Provides that each school board shall establish emergency procedures for life- threatening emergencies. Section 232.465, Florida Statutes (Supp. 1996), provides in pertinent part: Nonmedical school district personnel shall not be allowed to perform invasive medical services that require special medical knowledge, nursing judgment, and nursing assessment. The procedures include, but are not limited to: Sterile catheterization. Nasogastric tube feeding. Cleaning and maintaining a tracheostomy and deep suctioning of a tracheostomy. Nonmedical assistive personnel shall be allowed to perform health-related services upon successful completion of child-specific training by a registered nurse, a licensed practical nurse, a physician licensed pursuant to chapter 458 or chapter 459, or a physician assistant certified pursuant to chapter 458 or chapter 459. All procedures shall be monitored periodically by the nurse. Those procedures include, but are not limited to: Cleaning intermittent catheterization. Gastrostomy tube feeding. Monitoring blood glucose. Administering emergency injectable medication. For all other invasive medical services not listed in subsection (1) or subsection (2), a registered nurse, a licensed practical nurse, a physician licensed pursuant to chapter 458 or chapter 459, or a physician assistant certified pursuant to chapter 458 or chapter 459 shall determine if nonmedical school district personnel shall be allowed to perform such service. CS/HB 483 was amended at the committee level in the Florida House of Representatives, and subsections (1), (2), and (3) of Section 232.465, reflect that amendment. The Florida House of Representatives substituted CS/HB 483 for CS/SB 1114 which contained the same wording as the aforementioned amendment. The Senate Staff Analysis and Economic Impact Statement for CS/SB 1114 states in pertinent part: 3/ Summary: This bill requires district school boards to have certain qualified medical professionals train school-based personnel . . . Non- medical assistive personnel, who have successfully completed child-specific training by an RN or LPN, may perform certain health-related services (e.g., cleaning intermittent catheterization; gastrostomy tube-feeding; monitoring blood glucose; or administering emergency injectable medications). A RN must determine whether nonmedical school district personnel may do other invasive procedures. . . . . * * * This bill amends s. 232.46, Florida Statutes, and creates s. 232.465, Florida Statutes. * * * III. Effect of Proposed Changes: Nonmedical school district personnel are prohibited from performing invasive medical services (e.g., sterile catheterization, nasogastric tube-feeding, or cleaning and maintaining a tracheostomy) that require special knowledge or nursing judgement/assessment. Nonmedical assistive personnel, who have successfully completed child-specific training by an RN or LPN may perform health-related services, such as cleaning intermittent catheterization; gastrostomy tube-feeding; monitoring blood glucose; or administering emergency injectable medications. An RN must determine whether other invasive medical services may be done by nonmedical school district personnel. Each school board must establish procedures for life-threatening emergencies. The changes made by this bill protect the health, safety, and welfare of both public school students and school district personnel. The Senate Staff Analysis also contained the following statement on the last page: "This Senate staff analysis does not reflect the intent or official position of the bill’s sponsor or of the Florida Senate. 4/ Attached to the Senate Staff Analysis was a one-page document entitled "STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN COMMITTEE SUBSTITUTE FOR SB 1114," which states in pertinent part the following: 5/ [P]rohibits nonmedical school district personnel from performing certain invasive medical procedures that require medical or nursing knowledge. Allows nonmedical assistive personnel to perform health-related services upon successfully completing child-specific training by an RN and with periodic monitoring by the nurse. Requires an RN to determine whether nonmedical school district personnel may perform other invasive medical services. It is clear that the staff analysis for CS/HB 483 is inaccurate, regarding the prohibition of non-medical personnel from performing invasive techniques upon completing child- specific training by a nurse, with periodic monitoring by the nurse, and the nurse approving non-medical personnel performing other invasive techniques. The staff analysis failed to reflect that there was no prohibition under the conditions aforementioned. Catheterization performed by the paraprofessionals requires some degree of special medical knowledge, nursing judgment, and nursing assessment. However, the catheterization is permitted by Section 232.465, Florida Statutes (Supp. 1996). Respondent has not engaged in rulemaking regarding the implementation of Subsection 232.465(2), Florida Statutes (Supp. 1996).
The Issue Whether the Agency for Health Care Administration (AHCA or Agency) was entitled to change the rating of Gulf Coast Convalescent Center (Gulf Coast) from Standard to Conditional.
Findings Of Fact Gulf Coast is a nursing home located in Panama City, Florida, which is duly licensed under Chapter 400, Part II, Florida Statutes. AHCA is the state agency which licenses and regulates nursing homes in the state. As such, it is required to evaluate nursing homes in Florida, pursuant to Section 400.23(8), Florida Statutes. AHCA evaluates all Florida nursing homes at least every 15 months and assigns a rating of Standard or Conditional to each licensee. In addition to its regulatory duties under Florida law, the Agency is the state "survey agency" which, on behalf of the federal government, monitors nursing homes which receive Medicaid or Medicare funds. Ms. Bonnie Cile Baxter is employed by AHCA in the Division of Managed Care and Health Quality Assurance, Area Two. She is a registered nurse specialist and a graduate of the Florida State University School of Nursing. She has been a registered nurse for 27 years. She currently conducts surveys of nursing homes as required by state and federal law in AHCA's Area Two. Ms. Baxter visited Gulf Coast while conducting a licensure survey report. The survey began on March 13, 2000, and ended on March 15, 2000. As a result of the survey, a Statement of Deficiencies was issued on March 15, 2000. This report is referred to as a TAG 314. The report alleged Class II deficiencies. A Class II deficiency occurs when the outcome of the resident care directly affects the health, safety, or security of the resident. The TAG 314, set forth on a "2567" form, entered into evidence as Petitioner's Exhibit 1, is, in effect, the charging document. The residents to be checked were determined off-site by AHCA, prior to the survey. The information used to make these decisions was provided by the facility. The focus of the survey was pressure sores and nutrition and the four residents who were observed are referred to as Residents 16, 26, 22, and 15. Resident 16 Resident 16 was approximately 75 years of age. Ms. Baxter observed Resident 16 on March 13, 2000 at 9:00 a.m. Ms. Baxter observed that Resident 16 had a stage IV pressure sore. Pressure sores are evaluated in stages, beginning with stage I; a stage IV is the worst stage. A stage IV pressure sore may be open or closed, and it involves more than just the outer skin. A stage IV pressure sore involves severe damage to tissue. When evaluating the treatment of a resident with pressure sores, the evaluator observes the assessment and care plan and determines whether nutritional considerations have been addressed. The plan is evaluated to determine if it is sufficiently aggressive. What is implemented depends on the resident's need and the resident's desire. If the resident is incompetent to determine what care the resident wishes to accept, then a guardian may make the determination. Resident 16 was unable to make cognitive choices. Kimberly Roland, the Special Services Director at Gulf Coast at the time of the survey tried to contact Developmental Services of the Department of Children and Family Services with regard to a care plan for Resident 16 but the Agency asserted that it did not get involved with medical decisions. Ms. Baxter also tried, unsuccessfully, to determine who was authorized to make medical decisions on behalf of Resident 16. Resident 16 had been admitted to Gulf Coast on September 16, 1999. Facility staff noted that Resident 16 was first observed with a stage I pressure ulcer on February 1, 2000. The care plan developed by the facility in the case of Resident 16 did not facially address the pressure sore problem because it lacked specificity. Excellent nutrition serves to prevent pressure sores and to promote their healing. During the period subsequent to February 1, 2000, Resident 16 was without dentures, and this negatively affected her ability to ingest the type of foods which would address Patient 16's nutritional needs. There were discrepancies in Exhibit's 5, 7, and 8. Exhibit 5, which memorialized a one-time visit with a physician from Bay Psychiatric Services on February 12, 2000, indicated that Resident 16 did not exhibit symptoms of tardive dyskinesia, yet Exhibit 7 indicates that Resident 16 could not wear dentures because of involuntary movements related to tarsive dyskenesia on February 23, 2000. Exhibit 8, nurses' notes, indicate the presence of tardive dyskenesia involving movements of the tongue and body on January 27, 2000. Petitioner's Exhibit F demonstrated that Resident 16 had tardive dyskenesia symptoms, which resulted from long-time Mellaril use. The symptoms reported included involuntary movements of the tongue, which precluded the use of dentures. These involuntary movements were present on September 19, 1999. Mr. Gilliland, a licensed practical nurse with many years' experience working in nursing homes, stated he noticed that Resident 16 manifested involuntary movements of the tongue and body in December, 1999. If a person has tardive dyskenesia, it may preclude the utilization of dentures. The disappearance of Resident 16's dentures indicated a deficiency in security procedures but even if Resident 16 had dentures available, Resident 16 could not masticate hard food. Resident 16 had been on a mechanical soft diet prior to January 20, 2000. Subsequently, when Resident 16 no longer had the ability to masticate food, Resident 16 was put on a pureed diet. Resident 16's condition was the subject of an "at risk" meeting by the facility staff on February 15, 2000. Subsequently, Resident 16's nutritional needs were addressed with an enhanced diet. Resident 16 was provided with multi- vitamins and milkshakes twice a day in addition to other food. From February to March 2000, Resident 16 lost weight. The facility staff's efforts to provide Resident 16 with proper nutrition were appropriate under the circumstances. The first pressure sore on Resident 16 was found on February 1, 2000, and it was already a stage II without drainage. On February 18, 2000, the sore had advanced to a stage III and an additional pressure ulcer had formed on Resident 16's hip. This latter ulcer was also a stage II. By February 25, 2000, the ulcer on the hip changed to stage III and there was some draining. Subsequent to the inception of the ulcers, Resident 16 had been placed on a pressure reduction mattress. On March 3, 2000, more frequent turning was ordered by her attending physician. Mr. Gilliland observed that Resident 16 was mentally incapable of decision-making. Mr. Gilliland spent a lot of time with Resident 16. He was emotionally attached to Resident 16 who, to him, ". . . was like a little child." He spent a lot of time with Resident 16, kept Resident 16 clean and dry, and turned her frequently. At the time of the survey, the representatives of the state insisted that Resident 16 be fed through a tube. Dr. Haslam, Resident 16's physician, would not have ordered tube feeding had not the surveyors insisted that it be done. Resident 16 objected when Mr. Gilliland put the feeding tube in her nose. Resident 16 removed the tube. Mr. Gilliland put the tube in three or four times. Each time, Resident 16 removed it. When Dr. Haslam was informed of this, he told Mr. Gilliland that he could discontinue using the feeding tube. Resident 16 ate until two days before she died. When Resident 16 was admitted to Gulf Coast on September 3, 1999, Resident 16 could ambulate with assistance and was incontinent of bladder and bowel. By the time of the survey, Resident 16 could not walk at all and was bladder and bowel incontinent. At the time of the survey, and for several months before the survey, Resident 16 was bowel and bladder incontinent, had impaired mobility, and was an insulin-dependent diabetic. Resident 16 had occlusion of the arteries and veins of her lower extremities, which resulted in poor circulation. These are high-risk conditions for pressure wounds. Resident 26 Resident 26 was admitted to Gulf Coast on June 7, 1998. Resident 26 required extensive care with daily living activities and was approximately 83 years old at the time of the survey. On August 14, 1999, a stage I pressure sore was observed on the coccyx of Resident 26. By August 20, 1999, the pressure sore had become a stage II. By October 1999, the pressure sore on the coccyx had become a stage IV, and pressure sores had developed on the Resident 26's knee and on the left heel. Both of these sores were diagnosed as stage II. By November 11, 1999, the pressure sore on the coccyx was causing pain to Resident 26. It was determined on November 16, 1999, that the wound on the coccyx was infected with methicellin- resistant staphylococcus aureus (MRSA). MRSA is a type of infection that is resistant to antibiotics. It is communicable, and it is imperative that it be controlled. Vancomycin is the antibiotic of choice when treating MRSA. Resident 26 was administered Vancomycin and procedures were instituted to determine its effectiveness. The facility's staff determined that it would be best if a PICC line was installed in Resident 26. A PICC line is a method for administering antibiotics intravenously. In the case of Resident 26, records which tracked the status of the MRSA, were inadequate. Resident 26 refused to allow the PICC line to be placed. There is no indication whether Resident 26 refused Vancomycin administered in some other manner. On November 19, 1999, Dr. Ernest Haslam was notified of Resident 26’s refusal to allow installation of the PICC line. This information was not available at the time of the survey. At the time of the survey there were no documents indicating that the infection was being properly tracked or that there was an adequate treatment plan. The care plan for the treatment of Resident 26's pressure sores addressed providing proper nutrition, which included dietary supplements and pressure-relieving devices. Resident 26 was offered a feeding tube but Resident 26 declined. The implementation of the feeding tube was discussed by Resident 26's doctor with Resident 26's family and together they decided not to use it. The nutrition provided for Resident 26 was acceptable under the circumstances. Resident 26 was, at the time of the survey, and for several months before the survey, incontinent of both bowel and bladder. Resident 26's rheumatoid arthritis was so severe that Resident 26 was required to ingest anti-neoplastic drugs, which can kill cells. Resident 26 was admitted with a diagnosis of failure to thrive. Resident 26 was required to take Prednisone, which can contribute to the formation of pressure sores. Resident 26's albumin level was high, and a high albumin level promotes the formation of pressure sores. Resident 26 had a living will and had provided instructions not to resuscitate and resisted necessary treatment. These factors put Resident 26 at a high risk for pressure sores. Resident 22 Resident 22 was 67 years of age upon admission to Gulf Coast on May 12, 1999. Resident 22 had an open surgical wound on the hip upon admission, along with a fractured hip and gastrointestinal bleeding. Resident 22 also was anemic and had cardiovascular disease. On July 7, 1999, Resident 22 had a stage II pressure sore on the right heel, which had been present on admission. On September 2, 1999, it was noted that the left hip was infected and antibiotics were administered. On October 13, 1999, it was noted that Resident 22 had a stage III pressure sore on the right heel and a stage II open area on the right lateral foot. Poor nutrition was not a contributing factor with regard to Resident 22's pressure sores. On May 29, 1999, bilateral profo boots were prescribed for Resident 22, to be used for positioning of the feet while in bed. Dr. Osama Elshazly ordered the use of the profo boots. The use of profo boots was not included in the plan of care. Dr. Elshazly discontinued the use of the boots on January 1, 2000. There was speculation among the facility staff that the profo boots may have contributed to the pressure sores. Resident 22, at the time of the survey, and for several months before the survey, had pressure sore risk factors of diabetes mellitus, end-stage renal disease, coronary artery disease and arteriosclerosis obliterans. This latter condition means that the circulation in Resident 22's lower extremities was poor. Resident 15 Resident 15 is 87 years of age. Resident 15 was admitted to Gulf Coast on September 13, 1994. Upon admission, Resident 15 had ingrown toenails, a deformed left hammer toe, and other medical conditions involving the feet. Resident 15 required extensive assistance from staff in the activities of daily living and received nutritional support in the form of tube feeding. On December 17, 1999, Resident 15 was admitted to the Bay Medical Center due to a cerebrovascular accident, which is commonly referred to as a "stroke." Resident 15 was returned to Gulf Coast on December 23, 1999. After the cerebrovascular accident, Resident 15 was even less mobile and suffered a decline both mentally and medically. On March 1, 2000, Resident 15 was noted as having a pressure sore on her left bunion. Staff informed Ms. Baxter that they believed it occurred because Resident 15 had limited mobility. Resident 15, at the time of the survey and for several months before the survey, had pressure sore risk factors of bowel and bladder incontinence, congestive heart failure, and peripheral vascular disease. Resident 15 was a noninsulin- dependent diabetic.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Respondent enter a final order finding Petitioner not guilty of the alleged deficiencies and reinstating Petitioner's license rating to Standard as of March 15, 2000. DONE AND ENTERED this 27th day of December, 2000, in Tallahassee, Leon County, Florida. HARRY L. HOOPER Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 27th day of December, 2000. COPIES FURNISHED: Christine T. Messana, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Donna H. Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
The Issue Whether Respondent's license as a physician should be disciplined for the alleged violation of Section 458.331(1)(t), Florida Statutes, in that Respondent failed 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, by failing to treat the patient's preoperative coagulopathy and/or failing to use an alternate vein that would have allowed visualization of the shunt placement into the vein thereby reducing the risk of causing a hemorrhage given the patient's preoperative history, and, if so, what penalty should be imposed. AS TO CASE NO. 01-4407PL Whether Respondent's license as a physician should be disciplined for the alleged violation of 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 by failing to distally clamp part of the arteries prior to manipulation of the aneurysm and by failing to ensure periodic monitoring of the patient's condition postoperatively for evidence of ischemia or other problems and, if so, what penalty should be imposed.
Findings Of Fact Based on the evidence adduced at the final hearing, and the entire record in this proceeding, the following findings of fact are made: FACTS COMMON TO BOTH CASES Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.42, Florida Statutes, Chapters 456 and 458, Florida Statutes. At all times relevant to this proceeding, Respondent was a licensed physician in the State of Florida, having been issued license number ME 0036360. Respondent is board-certified in thoracic and general surgery. FACTS RELATED TO CASE NO. 01-4406PL Patient D.J.P. was a 54-year-old female with a history of liver resection for carcinoma. Patient D.J.P. had contracted Hepatitis C in the 1960s from a blood transfusion, after being the victim of a gun shot wound during a robbery at a convenience store. Patient D.J.P. subsequently had developed cirrhosis secondary to the Hepatitis C. Cirrhosis is a scarring process of the liver that results in the displacement of the normally functioning liver tissue. A healthy liver processes lymphatic fluid back into the bloodstream. However, a cirrhotic liver cannot properly process the lymphatic fluid back into the bloodstream. Therefore, lymphatic fluid backs up within the liver and weeps out the covering over the liver and into the abdominal cavity. Patient D.J.P. presented to Respondent on February 1, 1994, after being referred to Respondent by Michael Carey, M.D., the primary care physician, for evaluation for implanting a peritoneal venous shunt. A venous shunt is a conduit designed to take ascitic fluid from the abdomen and put it back in the vascular system. The shunt removes the fluid from the abdominal cavity and transports it to the vascular system where it can be absorbed. The procedure is for the patient's comfort and does not prolong the patient's life. The procedure is for patients with end stage liver disease. After obtaining a medical history and conducting a physical examination, Respondent's assessment of the Patient D.J.P. was massive ascites secondary to cirrhosis and previous liver resection. Respondent believed that Patient D.J.P. was a candidate for a venous shunt procedure due to the fact that she was very symptomatic from her massive ascites and she was on the maximum medical therapy. The mortality rate for this type of procedure is between 5 and 25 percent or at the very least, one-in-twenty patients would die from this procedure. Complications associated with this type of procedure include disseminated intravascular coagulopathy (hereinafter referred to as "DIC") which may lead to the general worsening of the disease or death. The patient was informed of this mortality rate as well as of the complications associated with this procedure. Patient D.J.P. decided to think about the procedure and contact Respondent's office when she wanted the shunt inserted. On February 10, 1994, Patient D.J.P. called Respondent's office and asked to have the shunt inserted as soon as possible. Respondent scheduled the procedure for February 14, 1994, and signed the written surgical consent form. Prior to the surgery, lab tests were performed on Patient D.J.P. The lab report indicated that the patient's prothrombin time was 14.3, with a normal range being 10.7-12.8. Prothrombin time ("PT") is a measurement of one aspect of the blood clotting mechanism. This was considered slightly abnormal and not an indication of a clotting problem or coagulopathy. Respondent decided it was not necessary to address Patient D.J.P.'s abnormal PT prior to the procedure by preoperatively administering Vitamin K or fresh frozen plasma. On February 14, 1994, Patient D.J.P. was transported to the operating room at approximately 12:10 p.m. After Patient D.J.P. was placed under general anesthesia, Respondent began the venous shunt operation at approximately 12:34 p.m. Respondent attempted to access the right jugular vein to insert the shunt. He found this vein to be unusable because it was too scarred from previous surgeries. Respondent then proceeded to access the right subclavian area to insert the shunt. Once the shunt was inserted into the subclavian area, Respondent positioned it in the superior vena cava. The shunt was noted to be in position in the superior vena cava. Respondent then removed eight liters of ascitic fluid from the abdominal cavity. After removing the ascitic fluid, he then put one liter of saline into the abdominal cavity to dilute any remaining ascitic fluid which allowed any remaining fluid to be more easily absorbed into the vascular system. The Patient's central venous pressure dropped from 8 to 2. Hespan and Albumin were then administered to replace any lost volume and it helped to increase the colloidomotic pressure. At this point, Patient D.J.P.'s central venous pressure (CVP) increased from 2 to 14 or 15. This is a faster than normal rate. Upon finding that the shunt was operating well, Respondent closed the abdominal portion and the patient was extubated. Petitioner claimed that fluoroscopy was not used to ensure that the shunt was positioned in the proper place. A Fluoroscope is like a real-time X-ray. A fluoroscope has two parts to it: a C-arm, which goes above the patient and underneath the bed, and two screens where the doctor can see what is going on. The C-arm is approximately 5-and-a-half feet tall. It is below the standard of care to do a venous shunt procedure without using a fluoroscope. It would enable Respondent to visualize the placement of the shunt. Felicia Whitmer, a scrub technician, and Rene Myers, a circulating nurse, prepared the operating room for Patient D.J.P.'s procedure on February 14, 1994. Both Felicia Whitmer and Rene Myers testified that there was no fluoroscope in the operating room on February 14, 1994. Respondent testified that there was a fluoroscope in the operating room on February 14, 1994, during Patient D.J.P.'s procedure and that he used it to assist him. The evidence is not clear and convincing that the fluoroscope was not used during the course of the operation. It is considered within the accepted standard of care to access the right subclavian vein to insert a shunt of this type because this vein follows a gentle curve or path. With this gentle curve in the vein, there is less risk of damage, i.e. puncture, to the vein. In contrast, the left jugular vein follows a more sharp-angled 70-degree bend-curve in the vein where one risks the danger of the shunt coming out of the bottom of the vein or perforation and, thereby, damaging the vein. Respondent ordered an X-ray to confirm placement of the shunt and catheter. The X-ray revealed that the shunt had good positioning but the right lung was filled with fluid. The patient was re-intubated and Respondent inserted a chest tube into the patient which would expand the patient's lung, oxygenate the patient and allow for fluid removal. Three or four liters of fluid were removed. The fluid was originally serous and pink tinged and shortly thereafter, turned bloody. Respondent noted that there was bruising around the wounds. Additionally, the patient's breathing became shallow and her blood pressure began to deteriorate. Resuscitative efforts were performed and Respondent re- entered the shunt area to clamp the shunt to prevent any ascites from flowing into the venous system and to prevent further coagulation and massive bleeding. Despite heroic resuscitative efforts, the patient's condition continued to deteriorate and the patient died. The cause of death was determined to be DIC and severe coagulopathy from drainage of the ascitic fluid into the venous system. Respondent made the determination that the patient did not have preoperative coagulopathy. Respondent testified that if the patient did have preoperative coagulopathy, he would not have performed the procedure because the patient would not be able to make the clotting factors well enough for problems that would occur after the shunt was inserted. It was Respondent's opinion that the patient did not have a serious clotting problem. Based on her lab report, Patient D.J.P. had a slightly abnormal PT and this was not an indication of a clotting problem. Respondent reviewed the lab reports and determined the PT (the measurement of one aspect of blood clotting mechanism), to be only slightly elevated. It measured 14.3 with a normal range being 10.7-12.8. Moreover, the PT International Normalized Ratio (INR) (which is the standardized measurement of PT) was 1.63 where the therapeutic range was 2-3. Therefore, this was slightly below average. Dr. Yahr testified that an abnormal clotting problem is a clinically evident problem and not an incident of a lab number. If Patient D.J.P. had a clotting abnormality, adverse conditions or symptoms would have been evident with the incisions that were made prior to the shunt being opened. Rather, normal clotting reactions occurred. Coagulation occurred right after the shunt was opened and the ascitic fluid began to flow into the atrium. Dr. Yahr testified that the etiology of the coagulation was the body's reaction to the ascitic fluid after the shunt was opened. Accordingly, it was Dr. Yahr's opinion that Respondent did not fail to treat the preoperative coagulopathy because upon his examination of the patient, he determined that no such preoperative coagulopathy existed prior to the procedure. Dr. Yahr testified that the patient did not have abnormal bleeding. Her liver failure was the result of scarring and abnormal liver function. Therefore, administration of clotting factors such as Vitamin K and fresh frozen plasma was not indicated or medically necessary. Petitioner presented the expert testimony of John W. Kilkenny, III, M.D. Dr. Kilkenny is board-certified in general surgery and has been for 11 years and is currently a professor with the University of Florida College of Medicine, Department of Surgery in Jacksonville, Florida, a position which he has held for the last six years. According to Dr. Kilkenny, Patient D.J.P.'s elevated PT was a cause for concern in that it was an indication that the patient's ability to clot or coagulate was diminished. It is not clear and convincing that the standard of care required that the elevated PT be treated by infusing fresh frozen plasma or Vitamin K. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by failing to use an alternate vein that would allow visualization of the placement of the shunt. Respondent first attempted to access the right jugular vein to insert the shunt but found it be unusable because it was too scarred. Respondent, acting as a reasonably prudent physician and using sound medical judgment, accessed the right subclavian area to insert the shunt. After the shunt was inserted into he subclavian vein, Respondent claimed he was able to visualize the placement of the shunt by the use of fluoroscopy. Furthermore, the operative notes seemed to indicated that the procedure was performed under fluoroscopic control and the shunt was found to be in position. Therefore, Respondent accessed an appropriate alterative vein-the subclavian vein, which allowed visualization, with the assistance of fluoroscopy, of the placement of the shunt. As to the second issue, Dr. Kilkenny opined that the standard of care requires direct visualization for insertion of the shunt. By not accessing a vein under direct visualization, such as with Respondent's subclavian approach, the surgeon is, in essence, hunting for the vein, and risking damage to the wall of the vein that may not be evident immediately. The rapid rise in CVP from 2 to 14 or 15 was also a concern for Dr. Kilkenny because it was not normal, and did not mean that the shunt was placed correctly of that the shunt was functioning properly. Dr. Kilkenny noted that it was unlikely that the bleeding in the chest cavity was caused by damage to an intercostals vessel when the chest tube was inserted because the chest X-ray that was taken prior to insertion of the chest tube showed a complete opacification of the right side and a shifting of the major vessels within the middle of the chest over to the left side. According to Dr. Kilkenny, the chest X-ray indicated that there had already been some sort of bleeding in the right chest prior to the insertion of the chest tube. Dr. Kilkenny disputed Respondent's theory that Patient D.J.P. died as a result of DIC. Dr. Kilkenny asserted that Respondent fell below the standard lf care in that, given Patient D.J.P.'s rapid decompensation, he failed to consider whether the patient's subclavian vein had been damaged, a condition which could have been addressed surgically. Dr. Yahr opined that Patient D.J.P. died of DIC that occurred within a short period of time after Respondent opened up the shunt and ascitic fluid was introduced into the atrium of the heart. Although Dr. Yahr further admitted that the bleeding in the chest could have occurred as a result of damage to the subclavian vein, and that it was below the standard of care to access the subclavian vein without using fluoroscopy, the evidence is not clear and convincing that either event occurred. It is found that Petitioner has failed to establish by clear and convincing evidence that the standard of care required Respondent to use an access site that allowed direct visualization of the placement of the shunt into the vein, or that Respondent failed to use fluoroscopy in order to directly visualize insertion of the shunt into the subclavian vein. AS TO CASE NO. 01-4407PL On August 22, 1997, Patient H.H., a 55-year-old female, was diagnosed with an abdominal aortic aneurysm measuring approximately 4.5 cm transverse diameter and beginning approximately 1-2 cm below an enlargement or swelling, of a blood vessel resulting in a weakening or thinning out of the vessel wall. On November 28, 1997, Patient H.H.'s aneurysm had grown to 5 cm within a three-month period and was occluded with partial thrombosis with a true lumen around 2.7 cm and extended down to the bifurcation of the abdominal iliac. This put the patient at risk for rupture of the aneurysm. Thrombosis is a blood clot within a vessel or within the vascular system. It does not embolize (travel) from another part of the body. It starts in a particular vessel and causes its damage from there. It is an acute clot that occurs in the vessel secondary to stasis (non-moving ) or some kind of coagulation or clotting deficiency or abnormality. Thrombotic activity most often begins by occluding the smaller vessels in the vascular system, such as those smaller veins located in the feet. On December 2, 1997, Patient H.H. first met with Respondent, who performed a complete medical history and physical examination and confirmed the presence of a 5 cm abdominal aneurysm. Patient H.H. was a 55-year-old female who smoked 1- and-a-half packs of cigarettes per day, had a blood pressure of 182/104 despite the fact that she was taking 50 mg Atenolol for hypertension (high blood pressure), and had a 30 percent blockage of the coronary artery. Previously, she had a cardiac catheterization, followed by an angioplasty of the femoral vessel in her left leg. Patient H.H. advised Respondent that her legs gave out on her after she walked two blocks, but that she did not have associated chest pain. Respondent confirmed earlier diagnosis of Patient H.H.'s medical condition as single vessel coronary artery disease, abdominal aortic aneurysm, hypertension, and claudication with femoral occlusive disease. Respondent also found diminished femoral pulses and palpable Dorsal pedal pulses present in both feet. Patient H.H.'s medical records indicated that this smoker of 30 years suffered from diabetes, peripheral vascular disease, intermittent clottication of the leg, hypertension, atherosclerotic disease, hypercoagulopathy, anthithrombin III deficiency, high cholesterol, and diminished protein and pH levels. Respondent prescribed prescription medication, Procardia to lower Patient H.H.'s blood pressure and Zyban to help her stop smoking. He recommended that the patient return in a week for follow-up. On December 15, 1997, Respondent continued to prepare Patient H.H for surgery. He again advised her to stop smoking and to purchase and take medication to help her stop smoking. Patient H.H.'s blood pressure was lower, 144/84, and although she had not purchased or taken the medication, she reduced her smoking down to one-half pack of cigarettes per day. Respondent then advised Patient H.H. to make plans to undergo the abdominal aortic aneurysm ("AAA") repair. Patient H.H. informed Respondent that she wanted to wait a little longer while she made financial arrangements to pay for the surgery. Respondent advised Patient H.H. to completely quit smoking before the surgery and advised her to return in one month for additional preoperative evaluation. On January 12, 1998, Respondent continued to prepare Patient H.H. for surgery by ordering a cardiac clearance (thallium evaluation) of the patient's heart to ensure she could tolerate the surgery before attempting the AAA repair. On February 3, 1998, Patient H.H. presented for the thallium evaluation of the heart and, on February 9, 1998, obtained cardiac clearance for repair of the AAA. On February 11, 1998, Respondent continued to prepare Patient H.H. for AAA surgery and suggested she donate two units of blood which would be used during the surgical procedure. Respondent scheduled AAA repair surgery for March 6, 1998. Respondent advised Patient H.H. of the risks associated with AAA surgery and specifically mentioned the risk of a heart attack, bleeding, kidney damage and loss of legs. He also advised that the risks associated with intra-operative AAA repair include spontaneous rupture, embolization of material from the wall distally, myocardial infarction, bleeding, injury to viscera of the small vessels, devascularization of the colon causing ischemic colitis, death, kidney blockage. Patient H.H. indicated she understood the risks and despite the risks associated with this type of surgical procedure, including the risk of death, she agreed to the procedure. Preoperative testing by angiogram was not required for Patient H.H. The aneurysm was a massive aneurysm presenting a very serious health risk of imminent rupture. The size of Patient H.H.'s aneurysm (5 cm) made AAA repair an emergency in a sense because there was almost a 100 percent chance of rupture with in the next six months. Any findings determined by angiogram would not have changed the outcome of the case because Respondent had to definitively treat the aneurysm first. Additionally, an angiogram is a very expensive test and Patient H.H. expressed a concern about her financial situation with respect to the AAA repair. It is reasonable to not do studies that a physician does not feel are absolutely necessary. The patient's financial concerns are part of the pathology. On March 6, 1998, Patient H.H. was admitted to Winter Haven Hospital and filled out and signed the Special Authorization for Medical and/or Surgical Treatment form indicating her consent to the surgical procedure which Respondent was to perform. She indicated that she understood the risks associated with such surgical procedure. Paragraph two of the informed consent form states in pertinent part: I hereby certify that I have given complete and informed consent for the above named operation and/or procedures, and Dr. L. Thomas has explained to me the reason why the above-named operation and/or procedure are considered appropriate, its advantages and possible complication, if any, as well as possible alternative modes of treatment. I also certify that no guarantee or assurance has been made as to the results that may be obtained. The operative procedure on the consent form was signed by Patient H.H. at 6:10 a.m. on March 6, 1998. Surgery indicated on the consent form was for a resection abdominal aortic aneurysm (AAA repair). After Patient H.H. was taken to the operating room and administration of anesthesia began, Respondent performed his routine preoperative check of femoral and pedal pulses. Checking for femoral and pedal pulses is the type of preoperative work-up Respondent routinely performs while he waits for the anesthesia to take its effect on the patient. The operative report indicates that the abdominal aneurysm was "very large" extending quite high within 1-2 cm from the renal vein and down to and involving the common and hypogastric arteries and noted to be "quite saccular" with "impending rupture in the near future at the neck." The common iliacs were noted to be "quite large and aneurysmatic." The external iliacs were soft but extremely small, "approximately 4-5 mm in size, certainly less than half, more like 1/4 the size of a normal iliac" but nevertheless usable vessels to make his anastomosis. As Respondent was bluntly dissecting (separating the tissues using the fingers) the aortic aneurysm from the venous plexus to position his proximal clamp when one of the lumbar veins was encountered and mass bleeding occurred. The venous plexus is a grouping of veins located under the aorta that can best be described as a wagon wheel. The system has a hub and all the veins in the grouping extend outward from the hub. If one of the veins in the grouping is injured, it will bleed heavily, but the bleeding is controllable. The lumbar veins are part of the venous plexus and a tear of the lumbar vein is a known risk during this type of surgery. Patient H.H. suffered the loss of three times the amount of blood as would have been routinely expected. The sudden blood loss caused the patient's condition to rapidly deteriorate. Dr. Wickstrom-Hill, Anesthesiologist, testified that had Respondent not controlled the blood loss, and had not maintained Patient H.H.'s vital signs, she would have died. Using sound medical judgment, Respondent elected to bypass the aneurysmatic common iliacs and make his anastomosis of the graft to the external iliacs in order to not disconnect or separate the aortic or common iliac aneurysms from the iliac vein. This is a very fragile vessel and could have resulted in further massive bleeding and possible death of the patient. A reasonable prudent physician faced with a similar circumstance and situation would not attempt to mobilize the aneurysm further if doing so would cause additional massive blood loss and possible death of the patient. The hypogastric arteries (a/k/a the internal iliacs) serve to provide the pelvic viscera (bladder, rectum, etc.) with blood. During the AAA repair, Respondent performed an embolectomy on both legs following manipulation of the aneurysm. The purpose of this procedure was to remove any debris which may have dislodged from the aneurysm and flowed distally to the legs. The procedure involves running a Fogarty catheter down the femoral arteries as far as the catheter will go, then inflating a balloon located at the end of the catheter. Once the balloon is inflated, the surgeon will extract the catheter, pulling the debris out of the artery. This process is repeated as necessary to remove all debris. Fresh clot was obtained from both legs, indicating a lack of debris. Prior to completing the anastomosis of the bifurcated graft to the aorta and external iliacs respectively, Respondent ran a Fogarty catheter down proximal (back into the graft itself), to remove any debris in the graft itself. Finally, he back-bled the graft (allowed blood to flow out of the graft, to, again, ensure that there existed no debris in the graft). On March 7, 1998, Patient H.H.'s medical condition stabilized such that Respondent felt it safe to return Patient H.H. to the operating room to undergo an additional embolectomy of the legs and an endarterectomy of the right femoral artery. The record demonstrates that Respondent believed he collected embolic debris from the femoral arteries. However, based upon the pathology report and the testimony of Dr. Zeller, the debris removed from Patient H.H. during this procedure was acute blood clots and atherosclerotic plaque. This finding is consistent with thrombotic material and not a result of debris coming from another location as it tends to demonstrate that Patient H.H. had a clotting disorder consistent with her medical history. The record also demonstrates that upon completion of the procedure, Patient H.H. was noted to have excellent pulses in the superficial and profunda femoral arteries distal to the anastomosis with good emptying and filing of the vessels. Before, during, and after the AAA repair, Respondent used Heparin (an anti-clotting drug) in an effort to prevent the formation of clots throughout Patient H.H.'s vascular system. Intraoperatively, on March 3, 1998, Respondent administered 10,000 units of Heparin. Normally a patient will respond to 5,000 units. Despite giving Patient H.H. twice the normal amount of Heparin, Patient H.H. continued to have a lowered clotting time. It is noted in the medical record that Patient H.H. had an Antithrombin III deficiency. Antithrombin III is one of the factors that control how blood in the human body clots. Patient H.H.'s Antithrombin III deficiency is a hereditary defect that contributed significantly to her continued clotting despite the use of pharmacological intervention (substantial amount of Heparin). Respondent testified that in his medical training and experience, Patient H.H.'s Antithrombin III deficiency level was near fatal. Because Patient H.H. was hypercoagulative, thus causing the small vessels to clot off, on March 13, 1998, Patient H.H. underwent bilateral above the knee amputations. Hypercoagulopathy is a tendency to clot without anything being done - the blood just clots. This can be caused by a lower-than- normal blood pressure for a period of time and by having an Antithrombin III deficiency. Respondent observed during the surgery that this patient was hypercoagulative because he could see the blood clotting in the wound despite the fact that Patient H.H. was on twice the normal amount of Heparin. Respondent practiced within the standard of care at all times during the treatment of Patient H.H. Blood-flow going retrograde back into the common and iliac aneurismal sacs did not place Patient H.H. at a risk of rupture. The operative report clearly demonstrates that the aortic aneurysm involved the common iliacs and extended below the hypogastric arteries. The operative report also demonstrates that the external iliacs were extremely small, approximately one-quarter of the normal size. A reasonable and prudent surgeon, faced with a similarly situated patient with a massive sized aneurysm and the extremely small size of the distal external iliacs, would conclude that the pressure gradient now being carried to the graft rather than to the aneurysm would diminish flow to the aneurysms making the possibility of rupture unlikely. Moreover, the aneurysms were filled with calcified atherosclerotic plaque and other thrombotic (non-mobile) material. Dr. Begelman testified that calcified aneurysms do not tend to rupture as much. On direct examination, Dr. Begelman, Petitioner's expert, could not conclusively determine whether Respondent's surgical treatment of Patient H.H. fell below the standard of care and that distal clamping is an intra-operative decision to be made by the surgeon. Dr. Begelman who testified that he accepted Respondent's opinion that the iliacs were too large or too thin walled and could not distally clamp the aneurysm and that such decisions are those made by the surgeon on the case. Drs. Begelman and Seller and Respondent testified that it is usual and customary during this type of surgical procedure to distally clamp the aorta and that it is expected of a reasonable and prudent surgeon to make every attempt to do so. Nevertheless, all three doctors recognized that there are times when you cannot or should not distally clamp if to do so would cause further injury to the patient or death. Patient H.H. presented with very massive aneurysms of both the aorta and common iliacs making distal clamping impossible without sacrificing the hypogastric arteries thus placing Patient H.H. at risk for further injury or death. Petitioner's expert accepted Respondent's assessment of the condition of the iliacs and that Respondent did not want to dissect the iliacs off the iliac vein, which one needs to do in order to tie off distally. Dr. Begelman testified that he could not ascertain whether Respondent fell below the standard of care with respect to Respondent's treatment of Patient H.H. intraoperatively. Respondent acted within the standard of care and, therefore, did not violate Section 458.331(1)(t), Florida Statutes, when he did not clamp the distal arteries before manipulation of the aneurysm. Respondent did not violate Section 458.331(1)(t), Florida Statutes, by sewing the bifurcated graft to the external iliacs and making no attempt to disconnect the aneurysm from the common and internal (a/k/a hypogastric) iliacs. The common and internal iliac tissues were also diseased because of their involvement with the aneurysms coupled with the fact that the aneurysm and surrounding tissue was inflamed. Inflammation causes the tissues of the surrounding viscera to become sticky and by that, stick together making separation difficult and more prone to bleeding on manipulation. Normally, the surgeon must bluntly dissect (lift up) the distal end of the aorta in order to place the distal clamps on the aorta below the aneurysm. However, the inflammation present in Patient H.H.'s aorta made it impossible to mobilize (lift up) the distal aorta for clamping because the tissue was stuck to the iliac vein which could have caused Patient H.H. to suffer a lethal blood loss. Normally, blood loss associated with this type of surgery amounts to 500 ccs for the total surgery. Patient H.H. lost 1500 ccs during the manipulation of the aortic aneurysm to place the proximal clamp and a total of 2400 ccs during the entire surgery which represented a blood loss of nearly 25-40 percent respectively of her estimated total blood volume. Respondent used sound medical judgment by making no attempt to dissect the common iliac from the subordinate tissue because, in his training and experience, the separation of tissues would have caused further, possible lethal bleeding. Drs. Begelman and Zeller, experts for Petitioner and Respondent respectively, testified that a reasonably prudent surgeon would not clamp below the common iliacs if to do so would sacrifice the hypogastric arteries and thereby cause irreparable harm or death to the patient. Dr. Zeller testified that the hypogastric arteries are of such importance that not clamping them, even at the risk of embolization, would nevertheless be within the standard of care. Respondent closely monitored Patient H.H. postoperatively. A reasonable and prudent surgeon is not expected to remain in the recovery room with his post-surgical patient until the patient becomes stable. Rather, the reasonable and prudent surgeon is expected to utilize the nursing staff who are charged with attending to the patient and to keep the physician updated on the patient's medical condition. Petitioner's witness, Doris Gutierrez, was the recovery room nurse on duty on March 6, 1998. Her duties included monitoring and reporting changes in Patient H.H.'s condition to Respondent. The record demonstrates that Respondent closely monitored Patient H.H. postoperatively by being in contact with the nursing staff and thereby giving orders for care and treatment to the nursing staff, either by telephone orders ("TO") or in person by verbal orders ("VO") to stabilize the patient. While in the recovery room, Patient H.H. was intubated, on a respirator. Petitioner's witnesses, Doris Gutierrez, confirmed Respondent's monitoring of Patient H.H. when she testified that she called Respondent several times to provide updates on Patient H.H.'s condition. The record demonstrates that postoperatively on March 6, 1998, Respondent wrote his initial order to the nursing staff at 12:30 p.m. while sitting in post-surgical recovery with Patient H.H. Thereafter, Respondent continued to monitor Patient H.H.'s condition and remained in communication with the nursing staff and wrote orders at 1:30 p.m., 2:30 p.m., 3:25 p.m., 5:00 p.m., 5:15 p.m., 8:15 p.m., and again on March 7, 1998 at 12:24 a.m. Following his TO on March 7, 1998, at 12:24 a.m., Respondent next saw Patient H.H. 7 1/2 hours later, at 8:00 a.m., prior to taking Patient H.H. to the surgery room to perform the endarterectomy and embolectomy. Ms. Gutierrez testified that she does not always note when the doctor comes back into the recovery room to give orders. She could not testify as to events that took place after Patient H.H. was transferred to the Surgical Intensive Care Unit ("SICU"). She also stated she did not know how many times Respondent went to SICU because she did not work in SICU when Patient H.H. was transferred out of the recovery room. Ms. Gutierrez was also unable to testify as to when the last time was that Respondent came to the recovery room. Respondent testified that there is a difference between a TO and a VO, the latter indicating that the physician was present in the room at the time he gave his order to the nurse. The evidence is not clear and convincing that Respondent did not provide appropriate postoperative monitoring of Patient H.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine: Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4406PL, and DOH Case No. 1994-12341. Enter a final order dismissing with prejudice the Administrative Complaint filed against Respondent in DOAH Case No. 01-4407PL, and DOH Case No. 1999-57795. DONE AND ENTERED this 8th day of August, 2002, in Tallahassee, Leon County, Florida. DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 8th day of August, 2002. COPIES FURNISHED: William R. Huseman, Esquire Romualdo C. Marquinez, Esquire Huseman, Marquinez & Schlegal, P.A. 6320 St. Augustine Road, Building 12 Jacksonville, Florida 32217 Kim Kluck, Esquire Richard J. Shoop, Esquire Agency for Health Care Administration Post Office Box 14229, Mail Stop 39A Tallahassee, Florida 32317-4229 Dr. John O. Agwunobi, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The issue in this case is whether the license of Allen B. Erde, M.D., should be disciplined by the Florida Board of Medicine based upon actions he is alleged to have taken, or failed to have taken, between August and November, 1986, in the care and treatment of his patient, C.W.
Findings Of Fact At all times material hereto, Respondent has been licensed as a physician in the State Of Florida, having been issued license number ME-0008625. Respondent was C.W.'s obstetrician during her pregnancy in 1986, and initially examined her on August 26, 1986, when she was six weeks pregnant. During this initial visit, C.W. was informed by Respondent that her pregnancy was progressing normally. At her second visit, on September 23, 1986, Respondent detected no fetal heartbeat. However, he informed C.W. that this was not a problem. He requested that she bring her husband with her for her third visit so that they both could hear the heartbeat. Prior to her third visit, C.W. saw Respondent in his office on October 6, 1986, complaining of urinary problems, and a stiff neck and back. Respondent treated her for a urinary tract infection. Later that same day she began to bleed vaginally, passed clots and experienced cramping pains. She then saw Respondent at the Winter Haven Hospital emergency room, but was told that nothing seemed wrong. Respondent advised her simply to go home, put her feet up, and rest. There were several other occasions during October, 1986, when C.W. experienced cramping and vaginal bleeding. She called Respondent each time to express her concerns, but was told simply to lie down, and keep her feet up. On October 22, 1986, C.W. and her husband visited Respondent for her third scheduled visit. No heartbeat was heard. Respondent again told C.W. that there was no cause for concern, the baby was just small and probably behind her pelvic bone. C.W. was presumably 14 weeks pregnant at this time, but Respondent's office records indicate that the fetus was decreasing in size, there was no weight gain, and no heartone. C.W. continued to experience pain and bleeding, sometimes accompanied by clots. She was not gaining weight, and had none of the other indications of pregnancy which she had experienced in her prior pregnancies. C.W. continued to express concern to Respondent, but his advice remained simply to lie down, and keep her feet up. In response to a five day episode of bleeding, C.W. saw Respondent in his office on November 12, 1986. Although she was 17 weeks pregnant at that time, Respondent's office records indicate a fetus 14 weeks in size. Respondent did not order any fetal viability tests, and there is no evidence in his office record that he considered any testing of the fetus. C.W. saw Respondent for her fourth scheduled visit on November 19, 1986, and, again, no fetal heartbeat was detected. She was still experiencing vaginal bleeding. Her uterus was only 10-12 weeks in size, although she was presumably 19 weeks pregnant at this time. C.W. was distraught, and expressed great concern to Respondent that she was presumably almost five months pregnant and no fetal heartbeat had ever been detected. C.W. demanded that Respondent do something. He then ordered a quantitative Beta-subunit Human Chorionic Gonadotropin blood test to determine her hormone level. On November 2l, 1986, Respondent called C.W. at her place of employment, and informed her that her hormone levels were extremely low, and that she might not have a viable pregnancy. He told her she should keep her next regularly scheduled appointment with him, but if she experienced any severe bleeding or cramping to call him. C.W. left work and became increasingly upset. She contacted him later on that same day for a more complete explanation of what she should expect. Respondent told her that the fetus was "reversing itself and was losing weight instead of gaining." C.W. was not informed by Respondent that the fetus was not viable, and she took his advice to mean that if she was extremely careful there was still a chance of carrying the pregnancy to term. Respondent admitted to the Petitioner's investigator, Jim Bates, that he knew the fetus was dead at this time, but he was trying to let nature take its course, and if she did not abort in two or three months, he would take the fetus. Because she was extremely upset and her friends were concerned about the advice she was receiving from the Respondent, an appointment with another obstetrician, Dr. Vincent Gatto, was made for C.W. by one of her friends. Dr. Gatto saw C.W. on or about November 21, 1986, and after examining her he immediately diagnosed her as having had a missed abortion. A sonogram confirmed this diagnosis. A dilation and curettage was performed on C.W., and subsequent pathological reports revealed remnants of an 8-week fetus. The medical records which Respondent maintained of his care and treatment of C.W. are incomplete and contain discrepancies concerning his evaluation of the patient. They do not reflect C.W.'s numerous telephone calls, or that she was increasingly upset over the course of her pregnancy. There is no delineation of a plan of treatment in these records, or any explanation of the type of treatment he was pursuing for her. There is no explanation or justification in these records of Respondent's failure to order a sonogram or test, other than the one Beta-subunit Human Chorionic Gonadotropin, for C.W., although she repeatedly reported vaginal bleeding and cramping, and there was a continuing inability to detect a fetal heartbeat. Respondent failed to carry out the correct tests on C.W., and therefore, he failed to make a correct diagnosis of missed abortion, or to treat her correctly. He allowed her to carry a dead fetus for almost two months. Retention of the products of a non-viable pregnancy can lead to several complications, including infection, blood clotting and psychological trauma. In fact, this experience caused C.W. severe emotional anguish. In his care and treatment of C.W., Respondent failed to meet the standard of care that is required of a physician practicing under similar conditions and circumstances.
Recommendation Based upon the foregoing, it is recommended that Florida Board of Medicine enter a Final Order suspending Respondent's license to practice medicine for a period of five years, and imposing an administrative fine of $3,000. DONE AND ENTERED this 21st day of August, 1989 in Tallahassee, Florida. DONALD D. CONN Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 Filed with the Clerk of the Division of Administrative Hearings this 21st day of August, 1989. APPENDIX (DOAH CASE NO. 88-4785) Rulings on the Petitioner's Proposed Findings of Fact: Adopted in Finding l. Adopted in Finding 2. Adopted in Finding 3. Adopted in Finding 4. Adopted in Finding 5. 6-7. Adopted in Finding 6. Adopted in Finding 7. Adopted in Finding 8. Adopted in Finding 9. Adopted in Finding 10. Adopted in Finding 11. Rejected as irrelevant. 14-17. Adopted in Finding 13. 18-21. Adopted in Finding 12. 22. Adopted in Finding 14. The Respondent did not file Proposed Findings of Fact. COPIES FURNISHED: Mary B. Radkins, Esquire Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, FL 32399-0792 Allen B. Erde, M.D. P. O. Box 1817 Winter Haven, FL 33883-1817 Allen B. Erde, M.D. 198 First Street, South Winter Haven, FL 33880 Dorothy Faircloth Executive Director Northwood Centre 1940 North Monroe Street Tallahassee, FL 32399-0792 Kenneth Easley, General Counsel Northwood Centre 1940 North Monroe Street Suite 60 Tallahassee, FL 32399-0729
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of February, 2000.
