The Issue The issue in this case is whether Jose Rosado, M.D., (Respondent), violated Section 458.331(1)(t), and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to Florida law. At all times material to these proceedings, Respondent has been a licensed physician in the State of Florida, having been issued license number ME 0068035. Respondent is board-certified in internal medicine and cardiovascular diseases. On March 10, 1997, Patient W.B.C., a 72-year-old man, arrived at the Leesburg Regional Medical Center (LRMC) emergency room. He complained of a sudden onset of weakness in his left hand and arm with numbness and tingling. Respondent was Patient W.B.C.'s primary care physician. Respondent admitted Patient W.B.C. with a diagnosis of cerebrovascular accident, mitral regurgitation, sick sinus syndrome and a history of myocardial infarction. Respondent ordered that Patient W.B.C. undergo a head CT scan, carotid Doppler, 2-D echocardiogram, an electroencephalogram, and a neurological consultation. Based on the test results and the consultation, Respondent diagnosed Patient W.B.C. with right cerebrovascular accident, mitral regurgitation, sick sinus syndrome, and history of myocardial infarction. Respondent then discharged the patient with Ticlid, a medication to prevent further cerebrovascular accidents and aspirin. On March 16, 1997, Patient W.B.C. was admitted to LRMC complaining of weakness, dizziness and a fever. His vital signs revealed a temperature of 103.0 F, a pulse of 118, and a blood pressure of 139/75. The emergency room physician ordered a chest x-ray, EKG, and urine and blood cultures. The chest x-ray revealed no acute cardiopulmonary abnormality. Urine tests revealed features consistent with the possibility of urosepsis. Blood work showed a white blood count of 9.15, elevated but within the normal range. Also on March 16, Respondent ordered that antibiotics be given prophylactically until the blood cultures came back from the laboratory. The cultures came back positive for staphylococcus aureus (staph). Staph is a notoriously “bad bug” and Staphylococci aureus bacteremia has a high mortality rate. Staph aureus can originate from several possible sources including infections through the urinary tract system, IV sites, aspiration into the lungs, and pneumonia (although not very common). Staphylococci in the bloodstream is known as bacteremia. Bacteremia can lead to endocarditis which is an infection of the inner lining of the heart and the heart valves. Endocarditis is a life-threatening condition that can quickly damage the heart valves and lead to heart failure or even death. Patients with certain cardiac conditions such as mitral valve regurgitation have a higher risk of developing endocarditis. Patient W.B.C. had such a history. On March 17, 1997, Patient W.B.C. was started on intravenous antibiotics by Respondent. Patient W.B.C. continued to receive the intravenous antibiotics for four days from March 17, 1997, through March 20, 1997. Respondent then switched Patient W.B.C. to oral antibiotics and kept the patient in the hospital one more day prior to discharging him with instruction to continue on the oral antibiotics for another ten days. Patient W.B.C. was discharged on March 21, 1997. He was not referred to an infectious disease specialist nor had Respondent obtained a consultation with any specialist to determine the length of time that the patient's infection should be treated. Respondent felt that he was adequately qualified to treat this patient, and the treatment appeared to work. Respondent thought the bacteria growing in the patient's blood "likely" originated from a lung infection. An infectious disease specialist should have been consulted to give guidance as to how long to treat the infection. The standard of care for treating a staph aureus infection where there is a known source of infection requires 14 days of intravenous antibiotics. Where the source is not known, then four to six weeks of antibiotics is recommended. In this case, the infection, a resistant staph infection found in the patient's blood, could have originated from several sources. While such staph could have sprung from a source in the lung, this is by no means likely and the infection could have originated from another source. The standard of care required that Respondent contact an infectious disease specialist for an evaluation and/or that he treat Patient W.B.C.’s staphylococcus with a minimum of 10 to days of intravenous antibiotics. On or about April 11, 1997, Patient W.B.C., presented to the emergency room at LRMC complaining of congestion, shortness of breath, fever of 100.3° F, and a cough. The emergency room physician performed a physical exam which revealed vital signs of a temperature of 101.3° F, a pulse of 104, and a blood pressure of 90/54. A chest x-ray, blood work and a urine culture were ordered. Patient W.B.C. was then admitted on April 11, 1997, with a diagnosis of pneumonia, an old cerebrovascular accident and coronary artery disease. The ER physician started Patient W.B.C. on a plan of treatment which included intravenous antibiotics, Vancomycin, IV fluids, and blood cultures. A physical examination on the patient revealed a temperature of 101.3° F, a pulse of 104 and blood pressure of 91/53. The attending physician diagnosed him with probable sepsis with pneumonia. On April 12, 1997, the blood cultures came back positive for Staphylococcus aureus bacteremia. On April 15, 1997, Patient W.B.C. was afebrile (without fever) and his white blood cell count was 10.23, which is within the normal range of 4.0 to 11.0. The patient continued in this condition through April 18, 1997, despite suffering from sepsis. On April 18, 1997, Respondent approved Patient W.B.C. for transfer to another institution for consideration for urgent mitral valve replacement. On April 19, 1997, Patient W.B.C. arrested and was pronounced dead at 5:53 a.m. Petitioner’s expert, Carlos Sotolongo, M.D., is board- certified in internal medicine, cardiovascular disease and nuclear cardiology. As established by Dr. Sotolongo's testimony, Respondent practiced below the standard of care by failing to treat Patient W.B.C. with a sufficient number of days of intravenous antibiotics and by failing to consult an infectious disease specialist. According to Dr. Sotolongo, there is a difference in the way that an uncomplicated pneumonia is treated as opposed to a pneumonia complicated by bacteremia. The latter must be treated more aggressively. Based on the foregoing, Respondent violated Section 458.331(1)(t), 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.
Recommendation Based on the foregoing, it is recommended that a Final Order be entered finding that Respondent violated Section 458.331(1)(t), and imposing a penalty which includes a formal reprimand, payment of an Administrative Fine in the amount of $5,000.00 within 180 days, and eight hours of Continuing Medical Education (CME) to be completed within the next 12 months dealing with the diagnosis and treatment of infections and/or risk management. DONE AND ENTERED this 1st day of October, 2003, in Tallahassee, Leon County, Florida. S DON W. DAVIS 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 1st day of October, 2003. COPIES FURNISHED: William M. Furlow, Esquire Katz, Kutter, Alderman, Bryant & Yon, P.A. Post Office Box 1877 Tallahassee, Florida 32302-1877 Kim M. Kluck, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701
The Issue The main issue in these proceedings is whether the Respondent Doctors is entitled to a certificate of need to establish a cardiac catheterization laboratory in Sarasota County. The parties stipulate that the only statutory and rule criteria which remain to be reviewed by the Hearing Officer areas follows: 1. Sections 381.705(1)(a) , (b) , (c) , (d) , , and (h), Florida Statutes. Section 38l.705(1)(h)) will be reviewed insofar as it refers to the availability of health manpower, management personnel, funds for capital and operating expenditures, the alternative uses of the applicant's resources, and the extent to which the proposed services will be accessible to all residents of the district. Section 38l.705(1)(1) and (n), Florida Statutes. Section 381.705(2)(a) , (b) and () Florida Statutes. Rule 10-5.011(1)(e), Florida Administrative Code. 5. Rule 10-5.011 (8)b and (8)0, (9)b, (9)d, (9) e (1) and (9)e(ll) The other statutory criteria and the remaining subsections of the rule have either been stipulated to by the parties or are inapplicable.
Findings Of Fact Respondent Doctors is a 168 bed, acute care general hospital. The hospital has a 40 bed cardiac care unit in which all beds are monitored. Hospital Corporation of America (HCA) owns Doctors. HCA owns or operates four hundred hospitals, including nineteen in Florida. Three of the in-state hospitals have cardiac catheterization laboratories (CCLs) . Two of the existing labs, located in Bradenton and Tallahassee, are available to assist in training and preparation which may be needed in the creation of a cardiac catheterization lab at Doctors. In September 1987, Doctors applied for Certificate of Need No. 5283 to establish a cardiac catheterization laboratory. The certificate of need has been preliminarily approved by the Respondent HRS. The initial agency action has been challenged by the Petitioner, Memorial. Memorial is the primary existing health care facility which would compete with Doctors by providing cardiac catheterization services in the same city where the new lab is to be located. Consistency with State and Local Health Plans The local health plan does not directly address the need for CCLs in the area. As nothing in the plan is relevant, no inconsistencies are created with the plan in the balancing of criteria with regard to the certificate of need determination. The State Health Plan provides that an average of 600 cardiac catheterization procedures per laboratory are to be maintained in each district through 1990. To determine the use rate under Rule 10-5.011, Florida Administrative Code, HRS must look to the number of procedures provided in the district between June 1984 and July 1986. The data reveals that seven programs completed 5,841 procedures. The required averages were exceeded by over two hundred procedures per lab. The need criteria has been met by Doctors for purposes of the State Health Plan, and the local plan, as it existed at the time of the initial review of the application. Existing Facilities Memorial is an 849 bed, acute care hospital which is a regional referral hospital in the area. The hospital provides Level 3 cardiac services. These services include angioplasty and open heart surgery in addition to cardiac catheterization. Memorial's first catheterization lab opened in 1978. Memorial currently contains two CCLs that assist in fulfilling the health care needs of the district. Before the recent addition of three CCLs within the district, Memorial served as the center for cardiac services. Manatee County and Charlotte County now have their own CCLs, which reduces Memorial's pool of potential patients in need of those services. In spite of reductions in the patient pool in the past, Memorial's use of its two CCLs has continued to grow. The Sarasota County area has a unique characteristic in that many tourists who arrive in the winter months (October-April) make use of the two local hospitals, Doctors and Memorial. The use of Memorial's CCLs increases as the local cardiologists need to complete a number of diagnostic tests in order to evaluate these new patients quickly, in times of critical need. Because of the season, Memorial's CCLs are heavily utilized for emergency procedures in the winter months. Accordingly, patients who have elective procedures scheduled are often reprioritized because of the emergency needs for use of the CCLs for more seriously ill patients. This last-minute rescheduling results in prolonged hospitalizations for the nonemergency patients and increases the cost of their medical care. Although the quality of testing does not appear to suffer from the season, a significant pool of patients is denied the opportunity for convenient medical care. The treating physicians are denied lab use and test results at the anticipated times within these patients' courses of treatment. Because of Memorial's inability to make the labs readily accessible to the pool of patients scheduled for elective procedures in the winter, a need exists for a CCL for this pool of patients. Doctors primarily seeks to provide cardiac catheterization services for diagnostic purposes. However, the lab will be capable of providing immediate endocardiac catheterization pacemaking in cases of cardiac arrest. A rapid mobilization team will be available for emergency procedures when the need arises. Angioplasty and open heart surgery procedures are not planned in conjunction with the CCL services. The lab will be in operation from 7:30 a.m. to 4:00 p.m. Monday through Friday, excluding holidays. Quality of Care Doctors currently provides quality care. There are no complaints outstanding, and the hospital has sufficient capabilities and support services to provide for a CCL. Doctors is JCAH accredited and provides the necessary services required under the catheterization rule. The same cardiologists are on staff of both Memorial and Doctors. Most of these physicians admit patients to both hospitals. Approximately one-third of Doctors' admissions are patients with cardiac problems. Many of these patients require catheterization and are transferred to Memorial. If it is determined that a catheterization is needed before admission, physicians admit those patients to Memorial. Alternative Care The other CCL which currently exists in Sarasota is an outpatient lab. This facility is owned and operated by a group of invasive cardiologists who also perform catheterizations at Memorial. Because the outpatient lab restricts a patient's selection of a physician able to perform a cardiac catheterization to the lab owners, this lab is not a realistic alternative for most patients or the referring physicians. A hospital-based lab gives those involved greater personal choice, and it is better equipped to handle unanticipated emergencies. Reasonable and Economic Accessibility Memorial's CCL services are not always accessible at the times scheduled for elective procedures. Some patients have remained hospitalized for days until they can be rescheduled. The delays increase the costs attached to the procedures due to the length of the hospital stay and the additional services required. Patients admitted to Doctors who require the services of a CCL are moved to Memorial by ambulance and have to be admitted there. These transfers cost patients an additional $180-$340. The ambulance charges are not reimbursed by medicare so the majority of the patients pay these charges themselves. The proposed lab will be capable of providing a range of diagnostic tests without the need to admit patients to another hospital prior to, or during treatment at, Doctors. This will reduce costs two ways: The additional ambulance and hospital costs will be omitted, and the proposed charge for the service is less than the current charge set by Memorial. Availability of Resources Doctors currently has a staff of trained cardiac nurses. There are two nurses on staff who have taught cardiac catheterization techniques at an accredited nursing school prior to moving to Sarasota. Although the husband and wife team was originally recruited to the area by Memorial, the two nurses chose to leave that facility because of the stress from the high level of activity in those labs. Doctors plans to cross train staff and to allow for a trained special procedures staff with alternating roles and duties. The proposed CCL will be staffed with 2.5 FTEs. These consist of the 1 FTE cardiac nurse and 1.5 FTE special procedures technicians. The budgeted FTEs do not include an allocation of time for an administrative director or secretarial/clerical services. The assistant hospital administrator anticipates that provisions will be made for management personnel at a later stage of the lab's development. Although the number of FTEs scheduled is less than those anticipated for a CCL which provides more complex procedures, the number scheduled by Doctors is reasonable for the number of services and kind of services it seeks to provide for the type of cardiac patients in its care. The proposal for the lab, as described in the application and revised in the omissions response, is financially feasible. The proposed expenditure of funds will serve the needs of the hospital's current patient pool as well as the special needs of the community for cardiac catheterization services. While Doctors' proposal does not increase geographic access, it will increase access in the population center, where services are currently inaccessible for one pool of patients at certain times. A need for a project is evidenced by the utilization of like and existing services. The rule which contains the need methodology takes into account the utilization of existing facilities in determination of numeric need. Numeric needs exists in this district, pursuant to Rule 10-5.011. Written Referral Agreement Doctors submitted a written referral agreement with a facility with open heart surgery services within 30 minutes travel time by emergency vehicle under average travel conditions. The agreement meets the general requirements of HRS. The agency does not require a detailed agreement during the preliminary granting of a certificate of need because other local providers do not wish to assist applicants during the CON process. However, such applicants are able to obtain more detailed agreements after the certificate is approved. The agency has determined that the agreement is sufficient. Because a rational basis has been given for the determination, the agency's acceptance of the agreement is given great weight by the Hearing Officer. Competition and Service Doctors' project will affect competition between Doctors and Memorial. Doctors will provide services for patients who would have gone to Memorial for such services in the past because Doctors was unable to provide the service. This is because of the geographic location and the fact that the same cardiologists are on staff at both hospitals. It appears that Doctors will be providing services for patients who are not in critical need of the services. This will allow Memorial to concentrate on the more complex cases has traditionally dealt with in the past. The stress from "unhappy" elective patients will be reduced at Memorial's labs, but so will the economic incentive for the staff which is related to the number of procedures performed. The elective cardiac catheterizations are quicker and easier to perform and increase the earnings of the lab staff. Both hospitals compete directly for staff. There is a "revolving- door" situation in staffing as local heath care personnel negotiates and works in either hospital, most of the time. Because of cash bonuses offered by Doctors for joining its staff Memorial is concerned about the adverse impact upon its CCL staff. Testimony presented at hearing showed by substantial and competent evidence that Memorial is committed to equipping its two labs with the most responsive equipment available for its more complex needs. The preservation of its current lab staff has been planned for by an able administrator. Recruitment is done nationwide and plans are being made with the local community college to provide nurses training involving cardiac catheterizations. The evidence also demonstrated that Memorial plans to meet the competition by improving the health services delivery, quality assurance, and cost-effectiveness. It appears that there is room for all three labs in Sarasota, and that healthy competition will occur in the area. Past and Proposed Indigent care Doctors has given little care to the medically indigent in the past. In fact, the hospital has maintained a written policy suggesting that those who cannot pay for services should be transferred by physicians to another hospital. Rather than admit such patients, the Doctors has chosen to pay into an indigent care fund. The new assistant director maintains that the current hospital policy is to provide health care to Medicaid and indigent patients in the CCL. Doctors projects that 2.5 per cent of its catheterization volume will be Medicaid and .75 per cent will be indigent care. Alternatives to the Project The alternative which has been developed and studied by Doctors is its past use of Memorial's CCLs. This use has been found to be more costly for elective cardiac catheterizations than the current proposal. The status quo has not met the needs of the elective catheterization patients in the geographical area. Similar Inpatient Services Memorial is using its similar facilities in an efficient manner. It is not using the facilities in an appropriate manner as most elective catheterization patients do not want to be in a hospital any longer than necessary. These people are predominantly type A personalities who do not like being rescheduled and charged additional hospital costs. Problems in Outpatient Inpatient Care Elective catheterization patients have a problem obtaining local inpatient care when they want it and when their cardiologists have prepared for it in their treatment plans. This does not appear to be a serious health problem, but the evidence has demonstrated it is a serious problem. Proposed Volume of Catheterizations Based upon numeric need, utilization of Memorial, physician support, and the growth history of other providers within the district, the projected utilization of 246 procedures in 1990, 294 in 1991, and 351 in 1992 is reasonable. There is no evidence which has been extrapolated from reliable data which shows that the proposed lab, coupled with alternative treatments and currently available noninvasive technological advancements, will reduce the average number of procedures per lab within the district below 600 each year. Due to the population growth projections for Sarasota County, approval of Doctors' application will have minimal impact on lab utilization at Memorial or other facilities within the district. Doctors' projected number of procedures will not decrease procedures at Memorial below its 1987 level of 2,495 cardiac catheterization procedures performed on an annual basis.
The Issue Whether Respondent violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and, if so, what discipline should be imposed.
Findings Of Fact The Department is charged with regulating the practice of licensed physicians pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2003). Dr. Dangl, whose address of record is 3900 Clark Road, Suite F-1, Sarasota, Florida 34233, was issued Florida license number ME 71286. On or before September 25, 2003, Dr. Dangl's office was approved to perform Level II Office surgical procedures by the Department. In a Level II Office surgery, "the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation." Fla. Admin. Code R. 648-9.009(4). Patient J.R., a 38-year-old female, presented to Dr. Dangl on September 25, 2003, for the removal of existing breast implants and the placement of larger saline implants. The surgery was scheduled to take place in Dr. Dangl's office. The surgical team consisted of Dr. Dangl; Amanda Fortner, R.N.; and Bruce Crow. Ms. Fortner assisted Dr. Dangl in administering anesthetic agents and other controlled substances, and monitored J.R. during the procedure. Her duties included documenting J.R.'s vital signs and the types and quantities of medications that were administered. A cardiac respiratory monitor, a pulse oximeter, and a blood pressure monitor were devices used to monitor J.R. during the surgery. A cardiac respiratory monitor records the heart rate, respirations, and the sinus rhythm of the heart. The oxygen saturation in the blood is measured by the pulse oximeter, which is placed on one of the patient's fingers. Blood pressure is monitored by the blood pressure machine. Bruce Crow was the surgical technician. During the surgical procedure, he made sure supplies and surgical instruments were ready, maintained the sterile field, and assisted Dr. Dangl with the procedure. At approximately 9:15 a.m. on September 25, 2003, Dr. Dangl started an IV in J.R.'s left hand and administered the following medications: one gram of Rocephin, 20 milligrams of Reglan, 50 milligrams of Demerol, ten milligrams of Valium, 25 milligrams of Ketamine and Versed. Dr. Dangl gave the initial medications, and Ms. Fortner administered additional drugs pursuant to Dr. Dangl's orders. J.R. was given an additional 200 milligrams of Demerol. The last dose of Demerol was administered by Ms. Fortner at 9:50 a.m. J.R. was a small person, and, for her weight and size, it took an unusual amount of Demerol to get J.R. sedated. Versed and Valium are sedative hypnotics, which sedate patients and cause them to become sleepy. Demerol is an analgesic, a pain medication. These medications can decrease respiration. Ketamine is a dissociate anesthetic, which does not cause respiratory depression. J.R. was also given a Propofol drip IV to help keep J.R. asleep. Propofol is a general anesthetic which depresses brain cells. The Propofol was mixed with a saline solution at a rate of one 55 cc vial per 100 cc's of saline. Ms. Fortner prepared the solution, which was initially administered by Dr. Dangl until he got it to the rate that he wanted. Once the surgery started, he would tell Ms. Fortner to speed-up or slow- down the drip as necessary. Three bottles of Propofol were used during the surgical procedure. J.R. was also given two liters of oxygen during the procedure. An oral airway was inserted into J.R.'s mouth during the early stages of the procedure. An oral airway is a long device that is inserted behind the tongue and goes deep into the patient's throat. In order to tolerate an oral airway, the patient would have to be in a deep level of sedation. J.R. was awake when the medications were started. She continued to talk through at least half of the time the medications were being administered. At one point during the surgery, J.R. "moaned a little bit, but then went right back to sleep." During the surgical procedure, Dr. Dangl sat J.R. up approximately three times to check the symmetry of the implants. J.R. continued to sleep through these checks. During the last time that J.R. was brought to a sitting position at approximately 11:55 a.m., the pulse oximeter alarmed. Thinking that the device may have fallen off J.R.'s finger, Ms. Fortner checked the device and also checked to make sure that the oximeter was not on the arm on which the blood pressure machine was placed. The pulse oximeter was on the correct finger. Ms. Fortner advised Dr. Dangl that something was wrong. She turned up the oxygen and placed an Ambu bag1 over the oral airway which had been placed in J.R.'s mouth at the beginning of the case. Ms. Fortner started Ambu bagging J.R. At Dr. Dangl's direction, Ms. Fortner turned off the Propofol drip. However, J.R.'s pulse oximeter reading did not improve. Not wanting to break the sterile field, Dr. Dangl yelled at Ms. Fortner, "Don't make me come back there and help your ass." When J.R. still did not improve, Dr. Dangl broke the sterile field, pushed Ms. Fortner aside, and began to Ambu bag J.R. Dr. Dangl checked J.R. for a pulse, but was unable to find one. Ms. Fortner checked for a pulse and thought that she may have found a faint pulse. Dr. Dangl, hearing the receptionist in the hallway, called to her to get Michelle Purdy, another employee of Dr. Dangl. The receptionist went to get Ms. Purdy and came back saying that Ms. Purdy was on the telephone. Dr. Dangl told the receptionist to get Ms. Purdy. Ms. Purdy, who is not a nurse, came into the operating area and tried to find a pulse for J.R. Unfortunately, Ms. Purdy tried to find a pulse using her thumbs. After being corrected by the surgical team, Ms. Purdy attempted to locate a pulse in the brachial, then the femoral, and then the pedal pulses, but she was unable to find a pulse. After being unable to locate a pulse, Dr. Dangl instructed one of his staff to call for emergency medical services (EMS). While Dr. Dangl and his employees were searching for a pulse, the surgical technician asked for leave to begin chest compressions. Mr. Crow told Dr. Dangl that the heart rate monitor was flat lining, meaning that it showed no basic heart rhythm for J.R. J.R.'s skin was gray and her fingers were turning blue. Dr. Dangl told Mr. Crow to wait. Dr. Dangl instructed Ms. Fortner to give J.R. three milligrams of Atropine two times. Ms. Fortner complied with his orders, but J.R. still had not started to breathe again. Mr. Crow continued to request Dr. Dangl to allow him to start chest compressions. After the administration of the Atropine failed to revive J.R., Dr. Dangl allowed Mr. Crow to begin chest compressions. From a minimum of two minutes to a maximum six minutes2 elapsed between the time Mr. Crow first asked to do chest compressions and when he began to do chest compressions. While chest compressions were being administered, Dr. Dangl ordered Ms. Fortner to administer Epinephrine to J.R. While Dr. Dangl continued to Ambu bag J.R., Mr. Crow administered three cycles of chest compressions. A cycle is 15 chest compressions to two Ambu breaths. J.R.'s heart rate returned and J.R. developed tachycardia, which means a high heart rate. About the time that J.R. revived and became stable, the paramedics arrived. J.R. was breathing, had a heart rate, and had a pulse oximeter reading of approximately 98. Neither the paramedics nor Dr. Dangl or any of his staff checked J.R.'s pupils. When the paramedics arrived, the surgery was not completed. The paramedics informed Dr. Dangl that another EMS team was on the way. Dr. Dangl and the paramedics agreed that Dr. Dangl could finish closing and suturing the wound, while waiting for the other EMS team to come and transport J.R. to the hospital. The paramedics stayed for a short time in the operating area monitoring J.R.'s vital signs and then left to make copies of J.R.'s chart, leaving Ms. Fortner to continue the monitoring of the vital signs. While Dr. Dangl was completing the procedure, J.R.'s vital signs were within normal range. Ms. Fortner periodically checked J.R.'s breathing by placing her hand over J.R.'s mouth. After Dr. Dangl completed suturing the wound, the second team of paramedics came into the operating area to transport J.R. The paramedics examined J.R.'s eyes, which were fixed and dilated. The paramedics immediately intubated J.R. and took her to the hospital. While at the hospital, Dr. Dangl admitted to J.R.'s fiancée that he had given J.R. "a lot of medication for her body size and weight," but that he thought J.R. was metabolizing the anesthetic very quickly. J.R. never regained consciousness after she was transported to the hospital. She died several months later from hypoxic encephalopathy, which means low oxygen brain damage. On September 26, 2003, Dr. Dangl dictated a report of operation. His documentation of J.R.'s "cardiorespiratory event" is as follows: Immediately prior to closure, the patient experienced a cardiorespiratory event that required CPR and resuscitative efforts. The EMS was activated and assumed care of the patient upon arrival. At this time the patient had responded to the resuscitative effort, vital signs were stable and permission was given by EMS to complete closure of the incisions prior to transport. The incisions were closed in a layered fashion with 3-0 PDS II and 5-0 nylon. A sterile dressing was placed over the incision sites. The patient was entubated [sic] by EMS prior to transport and left the O.R. via ambulance for Doctor's Hospital Emergency Room. Dr. Dangl signed a document entitled, "Operating Room Record." The record contained a section in which the medications that were administered should have been listed along with the time administered, the dosage, and the method of administration. That section of the record contained the following, "see anesthesia record," in lieu of listing the medications. The anesthesia record which was prepared by Ms. Fortner did not list all the medications that were administered to J.R. such as the Atropine and Epinephrine. She did not list the amount of Lidocaine or Propofol that was administered. It should have been obvious to Dr. Dangl when he reviewed the anesthesia report, that it was not correct. When Dr. Dangl prepared the Report of Operation and signed the Operating Room Record, he should have included the medications which he ordered and which were not included in the anesthesia report. Both Dr. Dangl and Ms. Fortner were certified in Advanced Cardiac Life Support at the time of the surgery. Ms. Fortner is not an anesthesiologist, a certified registered nurse anesthetist, or a physician assistant. Based on the testimony of Ms. Fortner that three 50 cc bottles of Propofol were used during the surgery, Dr. Joan Christie calculated that the dosage of Propofol that was administered was between 160 and 170 micrograms per kilo per minute. In a normal patient, who has received no other drugs, 100 micrograms per kilo per minute would be a lot of medication. J.R. received between 160 and 170 micrograms per kilo per minute on top of the other drugs that had been administered to her at the beginning of the procedure. The Propofol was administered in excessive amounts. Based on the evidence presented, it is clear that J.R. went from a Level II to a Level III office surgery during the surgical procedure. She tolerated an oral airway, which she could not do under a Level II or Level I. She was not responding purposefully to verbal commands or tactile stimulation. When J.R. was sat up to check the symmetry of her implants, she did not wake up or otherwise respond. Although she did moan at one time during the surgical procedure, that did not mean that she was either at Level I or Level II. Dr. Dangl has had no prior disciplinary actions taken against him by the Department.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Dangl violated Subsections 458.331(1)(m), (q), and (t), Florida Statutes (2003), and revoking his license to practice medicine. DONE AND ENTERED this 23rd day of February, 2005, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of February, 2005.
The Issue Whether disciplinary action should be taken against Respondent's license as a veterinarian based on alleged violations of Section 474.214, Florida Statutes (1997), as charged in the Administrative Complaints filed against Respondent in this proceeding. Count I of the Administrative Complaint in Case No. 00-2357 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances. Count II of the Administrative Complaint charged Respondent with a violation of Section 474.214(1)(ee), Florida Statutes (1997): failing to keep contemporaneously written medical records as prescribed by Rule 61G18-18.002(3), Florida Administrative Code. The Administrative Complaint in Case No. 00-2358 charged Respondent with a violation of Section 474.214(1)(r), Florida Statutes (1997): being guilty of incompetence or negligence by failing to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent veterinarian as being acceptable under similar conditions and circumstances.
Findings Of Fact Based on the evidence and testimony of the witnesses presented and the entire record in this proceeding, the following facts are found: At all times material, Respondent was a licensed veterinarian, having been issued license number VM 0003822. Facts relating to Case No. 00-2357 On or about March 5, 1998, Respondent performed a spay on "Midnight," a dog owned by Maryjane Greene and her husband. On or about March 8, 1998, "Midnight" expired at the Greene's home. When Mrs. Greene dropped off "Midnight," she was not sufficiently informed by Respondent about her option to have a pre-anesthesia lab work-up performed. There is no indication of an offer to perform a pre- anesthesia lab work-up, nor an indication that Mr. or Mrs. Greene declined such an offer, nor a consent form declining such a work-up, noted in the medical records kept by Respondent for "Midnight." It is a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the spay of "Midnight" included Xylzine (a.k.a. Rompun) a drug with a profound and potentially deleterious effect on the heart which may cause a first degree or second degree heart block. The anesthetic protocol used by Respondent during the spay of "Midnight" also included Ketamine, which is not approved for use in dogs. When used as an anesthetic protocol, it is considered an extra-label use of the drug. An extra-label use of a drug means that there have been no safety studies completed, and it cannot be adequately predicted what effects the medication will have on an animal on a consistent basis. There is no indication in Respondent's records for "Midnight" that Mrs. Greene was informed regarding the use of Ketamine in her dog's procedure. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug and not to have the client sign a consent form. Xylazine and Ketamine are both cardiac depressants. When used in combination they each make the other more of a cardiac depressant, thus requiring the administration of another drug, such as Atropine, to minimize the cardiac depressant effect. There is no indication in Respondent's medical records for "Midnight" that Atropine or any other drug was administered, other that the Xylazine and Ketamine. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xylazine and Ketamine was a deviation from the standard of care. Respondent's failure to administer Atropine or any other drug to minimize the cardiac depressant effects of Xyalzine and Ketamine played a substantial role in "Midnight's" demise. Upon picking up "Midnight," Mrs. Greene was given limited post-operative instructions. She was told not to give "Midnight" water until he could walk a straight line; not to give food until he could hold water down; only leash walks for 10 days; and no baths for 7-10 days. Respondent's post-operative discharge instructions given to Mrs. Greene did not comply with the standard of care in veterinary medicine. Facts relating to Case No. 00-2358 On or about August 25, 1998, Respondent performed surgery to remove a mass from the perineal area of "Snoopy," a nine-year-old obese Beagle belonging to Juan Ferras. There is no indication in Respondent's records for "Snoopy" that the surgery was performed due to an emergency, although the credible testimony indicated that it was an emergency. Given "Snoopy's" age (nine years) and weight (60 lbs.), it would be in the dog's best interest to perform a pre- anesthesia lab work-up, or to at least offer one to the owner. Respondent did not indicate in his medical records that he offered to perform a pre-anesthesia lab work-up on "Snoopy." In view of the emergency nature of the surgery, it was not a deviation from the standard of care to fail to offer a pre-anesthesia lab work-up. The anesthetic protocol used by Respondent during the procedure on "Snoopy" included Ketamine, which is not approved for use in dogs. When used, it is considered an extra-label use of the drug. Ketamine should be used with extreme caution in dogs for which the veterinarian is unaware of the renal function or the liver function of the dog. It is a deviation from the standard of care not to make a client aware of the use of an extra-label drug, and not to have the client sign a consent form. There is no indication in Respondent's records for "Snoopy" that Juan Ferras was informed regarding the use of Ketamine in his dog's procedure. Upon picking up "Snoopy," Mr. Ferras was given limited post-operative instructions. Respondent's failure to give specific post-operative discharge instructions to Mr. Ferras constituted a deviation from the standard of care. After discharge, "Snoopy" began vomiting and was readmitted to Respondent's facility on or about August 27, 1998. On or about August 28, 1998, "Snoopy" expired at Respondent's facility. There is no indication in Respondent's records on "Snoopy" that upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, Juan Ferras refused to pay or was only willing to pay a small portion of any treatment rendered to "Snoopy." Because of this finding it is unnecessary to address whether refusal to pay a fee is an appropriate defense by Respondent. Upon "Snoopy's" readmission to Respondent's facility, on or about August 27, 1998, "Snoopy" was determined to be approximately 11 percent dehydrated and in a state of shock. In order to correct the dehydration and maintain "Snoopy," it would have been required to administer approximately 4300-4400 ccs of fluid. Respondent's records indicate that only 800 ccs of fluids were administered to "Snoopy." This left "Snoopy" with a tremendous deficit of fluids. Respondent's explanation as to the reason for the small amount of fluid shown on "Snoopy's" chart is not credible. Respondent's failure to administer the correct amount of fluids constitutes a deviation from the standard of care. Upon readmission to Respondent's clinic, Respondnet did not draw blood or perform any type of bloodwork on "Snoopy." Respondent's failure to draw blood or perform any type of bloodwork on "Snoopy" after being readmitted for dehydration and vomiting and shock constitutes a deviation from the standard of care. The fluids which were administered to "Snoopy" were administered sub-cutaneously. The failure to insert an IV catheter to administer the fluids, rather than administering them sub-cutaneously, constitutes a deviation from the standard of care. One way of re-hydrating a dehydrated patient is by weighing the dog and then adding enough fluids to get the patient to its normal weight. There is no indication in Respondent's records that "Snoopy" was weighed at the end of the day on or about August 27, 1998, or that "Snoopy" weighed approximately 60 pounds late in the day on or about August 27, 1998. Respondent's records for "Snoopy" contain a notation at 10:00 p.m. August 27, 1998, of "ADR" which means "ain't doing right." A patient whose records indicate "ADR" should be continuously monitored or transferred to an emergency facility. "Snoopy" was not monitored overnight and through the early hours of the next morning. Had Respondent taken appropriate steps with regards to fluid resuscitation upon "Snoopy's" readmission to Respondent's facility, "Snoopy's" chance of survival would have been much higher.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is recommended that a final order be render by the Board of Veterinary Medicine, as follows: Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statutes (1997), as alleged in Count I of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case NO. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(ee), Florida Statutes (1997), as alleged in Count II of the Administrative Complaint for DOAH Case No. 00-2357 (DBPR Case No. 98-11323). Finding Respondent guilty of having violated Section 474.214(1)(r), Florida Statues (1997), as alleged in the Administrative Complaint for DOAH Case No. 00-2358 (DBPR Case No. 98-21230). In light of these findings of guilt and aggravating circumstances, the following penalties are recommended: A thirty-day suspension of licensure. An administrative fine in the amount of four-thousand dollars ($4000.00). Assessing costs of investigation and prosecution, in the amount of $973.24 for Case No. 00-2357 and $684.29 for Case No. 00-2358. Five years of monitored probation upon such terms and conditions as the Board finds necessary and reasonable. DONE AND ENTERED this 19th day of December, 2000, 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 19th day of December, 2000. COPIES FURNISHED: Walter H. Dornbusch, D.V.M. 1117 Malabar Road, Northeast Palm Bay, Florida 32907 Robert H. Hosay, Esquire Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-2202 Barbara D. Auger, General Counsel Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792 Sherry Landrum, Director Board of Veterinary Medicine Department of Business and Professional Regulation Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
The Issue Whether Respondent's license to practice chiropractic should be suspended or revoked, or the licensee otherwise disciplined, for alleged violations of Chapter 460, F.S., as set forth in the Administrative Complaint, dated May 11, 1984. This case arises as a result of charges filed by Petitioner in an Amended Administrative Complaint alleging that Respondent violated various provisions of Chapter 460, Florida Statutes, in performing procedures intended to terminate the pregnancy of a female patient in 1984, which resulted in a criminal conviction. At the hearing, Petitioner presented the testimony of Alfred Clum, a Department investigator, Charles E. Robinson, Chief Investigator, Bay County Sheriff's Office, Dr. March A. Wolf, obstetrician and gynecologist, Patty Smith, Deputy Clerk, Bay County Circuit Court, David W. Morrison and Barbara Morrison. Respondent testified in his own behalf. Petitioner submitted 6 exhibits in evidence and Respondent submitted a late-filed exhibit. Although the parties were provided time to file an agreed transcription of tape recordings as a late- filed exhibit, such exhibit has not been filed as of this date. At the commencement of the hearing, Petitioner amended paragraphs 11 and 17 of the Amended Administrative Complaint to correct scrivener's errors, thus changing the alleged violations of Section 460.413(1)(g) to 460.413(1)(q). Similarly, paragraph 15 was corrected from Section 460.1413(1)(u) to 460.413(1)(u). Although the parties were accorded a specified period in which to file post-hearing proposed findings of fact, they failed to do so.
Findings Of Fact Respondent Thomas F. Yancey was licensed to practice chiropractic in the State of Florida in 1966 and was so licensed at all times material to the administrative complaint herein. On May 15, 1984, an Order of Emergency Suspension was issued against Respondent's license by the Secretary of the Department of Professional Regulation which is still in effect. Respondent has never been licensed by the Florida State Board of Medical Examiners or Board of Osteopathic Medical Examiners. (Petitioner's Exhibits 1-4, Testimony of Respondent) In August 1983, Barbara D. Morrison visited Respondent's office in Panama City, Florida, for the purpose of obtaining an abortion. She paid him $150.00, but obtained a refund because, according to her, "it didn't work." Respondent testified that Morrison had come to him at that time for an abortion, but that he had told her "I don't do that," but that he could arrange it for her if she needed it. He admitted that he gave her an examination and told her that he suspected she was pregnant. He further testified that since Morrison had given his receptionist some money, he wrote her a check for $150.00. (Testimony of B. Morrison, Respondent, Respondent's Exhibit 1) During the latter part of March 1984, Morrison again went to Respondent's office and told him she wanted an abortion. He told her it would cost $150.00. She then went into a room in the office where she put on a gown, laid on a table and placed her feet in stirrups. Respondent "mashed" on her stomach to see if she was pregnant and then "gave me some kind of shot in my uterus." Respondent told her that he had used a saline solution. Morrison's ex-husband, David W. Morrison, went to Respondent's office while Barbara Morrison was there to loan her $60.00 for the abortion. He gave the money to Respondent's receptionist. He observed Barbara in a back room of Respondent's office, but no one else was there at the time. He later took her home. (Testimony of B. Morrison, D. Morrison) The injection that Barbara Morrison received from Respondent in March 1984 did not produce any results so she returned to his office about a week later on April 2, 1984. At that time, Respondent followed the same procedures as on the previous occasion and injected a solution into her again. According to Barbara Morrison, "it felt like it went to my heart. It hurt real bad. I asked him what he did and he said nothing. He said to lay down and I would be all right, but my body was swelling up." She was thereafter taken by a companion to the Bay County Medical Center where she received emergency treatment. On the same day, she was transferred to the Gulf Coast Hospital and treated by Dr. Mark A. Wolf, an obstetrician/gynecologist who had treated her for a "spontaneous" abortion in 1983. Upon examination, Dr. Wolf found that Morrison was experiencing lower abdominal pain and was also having some reaction to medication. There was no evidence of infection at the time. Ultrasound studies showed a viable pregnancy in the uterus with some fluid or swelling around the gestational sack. Morrison told him at the time that she had had an abortion attempted to be performed on her and that she believed that is what caused some of her problems. Dr. Wolf believed there was a significant risk of infection and admitted her to the hospital. She thereafter started to develop signs of infection and to spontaneously abort her pregnancy. He therefore completed the abortion by a dilation and evacuation of the uterus. (Testimony of B. Morrison, Wolf) On April 10, 1984, pursuant to an investigation conducted by the Bay County Sheriff's Office, Barbara Morrison returned to Respondent's office with an electronic transmitter concealed on her person that could be monitored by the law enforcement personnel in a nearby vehicle. She told Respondent that she needed another "shot" because the other one hadn't worked. They made an arrangement for her to return on the next day, April 11, for another abortion attempt. Morrison asked Respondent for a receipt for the money that she had paid and he wrote her one. On the following day, she returned, again equipped with a listening device, and went to Respondent's back room, put on a gown, and got on the table. She asked Respondent if he was going to give her a shot like the one he gave her the last time and he said yes. At this point, law enforcement personnel entered the room, observed Morrison sitting on the table with a gown on, and Respondent standing near the foot of the examination table with an instrument tray in his hand. The office was searched pursuant to a search warrant, but no medical records concerning Morrison were found. Respondent was placed under arrest at the time. On April 23, 1984, a departmental investigator, Dwayne Clum, talked to Respondent outside his office and provided him with a release of medical records which had been signed by Barbara Morrison. Respondent informed Clum that he had no medical records on Morrison. Investigator Clum accompanied the Sheriff's personnel when they entered Respondent's office on April 11, and took photographs of the examination table and tray containing various items including a metallic syringe, a vaginal speculum, and a metal cannula. However, there was no fluid in the syringe and the cannula, which can be used as an attachment to a syringe, did not fit the syringe on the tray. (Testimony of B. Morrison, Clum, Robinson, Wolf, Petitioner's Exhibit 5) On October 29, 1984, Respondent was found guilty of criminal abortion, performing an abortion in an unlawful place, and two counts of practicing medicine without a medical license. Imposition of sentence was withheld and he was placed on probation for a period of five years. The conviction was based on Respondent's activities in connection with Barbara Morrison on April 2 and 11, 1984. He was found not guilty of practicing medicine without a license in connection with his alleged performing of an internal examination of and injecting a solution into the reproductive organs of Morrison on or about March 15, 1984. (Petitioner's Composite Exhibit 7) Respondent denied at the hearing that he had seen Morrison in March of 1984. He claimed that she had left numerous calls at his house during the latter part of March, but that he had been at a seminar. He admitted that he saw her either on April 1 or 2, 1984, and performed a pelvic examination. He claimed that he had to wash her vagina prior to the examination and that there was pus oozing therefrom with a strong odor, and that he therefore took a large ear syringe and washed out the area with a saline solution. He told her at this time that he was not sure that she was pregnant. He further testified that she came back about a week later demanding to see him and that he told her that he could see her the next day. However, prior to any action on his part on that day, the police entered his office. He denied ever agreeing with her to perform an abortion or injecting anything into her uterus. He explained that the reason he had no medical records on Morrison was because the exams were strictly of an emergency nature. Respondent denied receiving any money from Morrison on April 2, 1984, but said that she "threw a five dollar bill" on his desk on April 11. Respondent's testimony in the above respects is not deemed credible and is accordingly rejected. (Testimony of Respondent) Although the term "obstetrics" normally deals with the outcome of a live birth, the aborting of a fetus or termination of pregnancy can also be included in the definition. Such an invasive procedure involving the injection of a substance into the uterus also might be encompassed within the term "surgery." Termination of a pregnancy constitutes the practice of medicine that only may be performed by a licensed physician or osteopath. (Testimony of Wolf)
Recommendation That the Board of Chiropractic issue a final order which suspends the license of Thomas F. Yancey to practice chiropractic for a period of two years, as a result of established violations of subsections 460.413(1)(n), (q) and (u), Florida Statutes. DONE and ENTERED this 14th day of January, 1986, in Tallahassee, Florida. THOMAS C. OLDHAM 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 14th day of January, 1986. COPIES FURNISHED: Fred Varn Executive Director Board of Chiropractic 130 North Monroe Street Tallahassee, Florida 32301 Edward C. Hill, Jr., Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Roger D. Patterson, Esquire 17208 W. Hutchinson Road Panama City Beach, Florida 32407
