The Issue With regard to Count I of the Administrative Complaint, the issue is whether the Respondent possessed a controlled substance for other than a legitimate purpose. The Respondent admits possession; therefore, the issue is whether she possessed the controlled substance for legitimate purposes. Count II alleges 47 specific instances in which the Respondent violated hospital policy by failing to account for a controlled substance by properly recording withdrawals and administrations of the controlled substance. The petitioner alleges that the Respondent made false reports or a record which she knew was false and, by the aforesaid conduct, failed to conform to minimal standards of acceptable and prevailing nursing practices. With regard to Count II, both factual and legal issues are controverted. The Petitioner submitted post hearing proposed findings of fact in the form of a proposed recommended order. To the extent the proposed findings of fact have not been included in the factual findings in this order, they are specifically rejected as being irrelevant, not being based upon the most credible evidence, or not being a finding of fact.
Findings Of Fact Count I The Respondent is a licensed registered nurse and duly certified registered nurse anesthetist (CRNA) holding license number 40895-A. At all times relating to the charges, the Respondent was so licensed and was employed as a CRNA at Bayfront Medical Center (Bayfront), a full-service hospital located in St. Petersburg, Florida. A CRNA essentially performs the acts of an anesthesiologist, inducing and maintaining in surgical patients a physical state which is appropriate for the particular surgical procedure to be performed through the administration of drugs to the patient. On March 4, 1981, the Respondent had been working in the operating room at Bayfront during her regular shift and had just completed a surgical procedure at 12:00 noon, when at approximately 1:00 p.m. she was called to the administrative offices. She changed from her operating room clothes, took off her warm-up operating room jacket, and put on a long lab coat. The Respondent proceeded to the administrative offices, where she remained until she accompanied Donna Roberts, Manager, Surgical Services, back to Respondent's locker, where a consent search was conducted by Roberts. Roberts' search revealed an ampule which was labeled Sublimaze, a trade name for the controlled substance fentanyl, in the pocket of Respondent's lab coat, which was in the Respondent's locker in the dressing room for female surgical staff at Bay front. Said locker room is located some 25 to 30 feet from the operating rooms. The record reveals that CRNAs and anesthesiologists at Bayfront checked out medications at the beginning of their shifts at approximately 7:00 a.m. and retained these medications throughout the day, returning the remaining medications at the end of the day at approximately 5:00 to 6:00 p.m. The record reveals that CRNAs and anesthesiologists have breaks, eat lunch, and are at the hospital when not involved in surgery. Count II The following procedures were in effect and followed by staff at Bayfront at the time involved in the Administrative Complaint. Although these procedures may not comport with the legal requirements, they were at that time and place the minimal acceptable standards of conduct accepted by the hospital administration. CRNAs and anesthesiologists drew their medications for the day early in the morning from the recovery room nurses in the recovery room. CRNAs and anesthesiologists on the hospital staff frequently drew medications for unknown patients, indicating type of surgery or in some instances giving the patient's name as John Smith. There was no requirement for CRNAs or anesthesiologists to initial narcotics records showing receipt of medications drawn from the recovery room nurse, who was charged with issuing these controlled substances. The names of patients were not required to be entered on the narcotics record. It was not uncommon for CRNAs and anesthesiologists on the hospital staff to be changed from one patient to another prior to the commencement of surgery. It was also not uncommon for one CRNA to relieve another CRNA during a surgical procedure and to finish the procedure. CRNAs and anesthesiologists were not required to show wastage. They used the quantity of drugs necessary during a surgical procedure, and if they ran out they had the circulating nurse in the operating room obtain additional medications from the recovery room nurse. Members of the hospital staff and other anesthesiologists turned in excess medication at the end of the day. Sublimaze or fentanyl was introduced as an anesthetic agent and for many years was treated much like sodium pentathol, which is not controlled. Sublimaze or fentanyl is a controlled narcotic substance. Some of the CRNAs employed at Bayfront use few, if any, controlled substances in their practice. However, many of the anesthesiologists use fentanyl regularly. The Respondent appears to have been the only CRNA who regularly used Sublimaze or fentanyl in her practice. The following findings regarding the lettered paragraphs of the Administrative Complaint are summarized below by date: On 02/02/81, the Respondent had signed out to her two ampules of Sublimaze for the patient Forman. She did not work on Forman. She did work on the patients Kilmark and Whitehead. She administered 3.5 cc (two ampules) of Sublimaze to Kilmark and 4 cc (two ampules) of Sublimaze to Whitehead. On 02/04/81, the Respondent had signed out to her ten ampules of Sublimaze for the patient Warren. She worked on Warren and administered 19 cc (ten ampules) of Sublimaze to him. On 02/06/81, the Respondent had signed out to her two ampules of Sublimaze for the patient Asaro, three ampules of Sublimaze for the patient Mastry, and three ampules of Sublimaze for an unknown patient. The records show that the Respondent administered 9 cc (five ampules) of Sublimaze to the patient McMullen. The Respondent did not turn in or account for three ampules of Sublimaze. On 02/09/81, the Respondent had signed out to her three ampules of Sublimaze for the patient Hull and four ampules of Sublimaze for an unknown patient. The records reveal she participated in three surgeries on this date on patients Braswell, Walker and Morgan. The patient Hill was assigned to another anesthesiologist. The record reveals that the Respondent administered 5 cc (three ampules) of Sublimaze to Braswell, 6 cc (three ampules) of Sublimaze to Walker, and none to Morgan. The Respondent failed to turn in or account for one ampule of Sublimaze. On 02/11/81, the Respondent had signed out to her five ampules of Sublimaze for the patient Brown and three ampules of Sublimaze for the patient Graham. She participated only in the surgery on Graham. It appears that CRNA Kolodzeij may have anesthetized Brown. The Respondent administered 6 cc (three ampules) to Graham. Kolodzeij drew no medications for her surgeries on the date in question. Kolodzeij relieved Respondent during the Graham surgery and finished the procedure. The Respondent left for Kolodzeij to use on Graham all the ampules of Sublimaze which she had checked out. On 02/13/81, the Respondent had signed out to her five ampules of Sublimaze for the patient Smith and five ampules of Sublimaze for an unknown patient. The records reveal no patient Smith. The Respondent's only surgery on this date was the patient Vielhauber. The record reveals that the Respondent administered 6 cc (three ampules) of Sublimaze to Vielhauber. She failed to turn in or account for seven ampules of Sublimaze. On 02/15/81, the Respondent had signed out to her four ampules of Sublimaze for the patient Jocalsky. She participated in no surgeries on the date in question. The Respondent did not turn in or account for four ampules of Sublimaze. On 02/16/81, the Respondent had signed out to her six ampules of Sublimaze for an unknown patient and four ampules of Sublimaze for the patient Smith. The records reveal that the Respondent participated in five surgeries on the date in question. She administered 4 cc (two ampules) of Sublimaze to the patient Harrison, 3.5 cc (two ampules) to the patient Stephens, 6 cc (three ampules) to the patient Miller, 6 cc (three ampules) to the patient Fuldaver, and none to the patient Flournay, for a total of ten ampules. The records reflect that CRNA Robbins participated in surgery on a patient Jacobson, for which Robbins drew no medications. On 02/18/81, the Respondent had signed out to her six ampules of Sublimaze for unnamed patients and five ampules of Sublimaze for the patient Nelson. She participated in two surgeries on the date in question. She administered 3.5 cc (two ampules) of Sublimaze to the patient Rothwell and 12 cc (six ampules) to Nelson. Ford, R.N., as recovery room nurse, received two ampules of Sublimaze on the date in question as turned in from an unrecorded source. These are credited against the ampules withdrawn by the Respondent. The Respondent failed to turn in or account for one ampule of Sublimaze. On 02/20/81, the Respondent had signed out to her four ampules of Sublimaze for the patient Baker. She administered 6 cc (three ampules) of Sublimaze to Baker. The Respondent failed to turn in or account for one ampule of Sublimaze. On 02/23/21, the Respondent had signed out to her ten ampules of Sublimaze for the patient Hicks. The record reflects that the Respondent administered 9 cc (five ampules) to Hicks. The Respondent failed to account for or turn in five ampules of Sublimaze. On 02/24/81, the Respondent had signed out to her two ampules of Sublimaze for the patient Jackson, two ampules of Sublimaze for the patient Marlin, and five ampules of Sublimaze for an unnamed patient. She participated in two surgeries on the date in question. She administered 5 cc (three ampules) of Sublimaze to Jackson and 3 cc (two ampules) of Sublimaze to the patient Lumpkin. The Respondent failed to account for or turn in four ampules of Sublimaze. On 02/27/81, the Respondent had signed out to her four ampules of Sublimaze for an obstetrical patient at 6:30 a.m. on the date in question and three ampules of Sublimaze for an obstetrical patient at 6:45 p.m. on the date in question. She participated in two surgeries on this date, one at 9:15 a.m. and one at 9:30 a.m. She administered 4 cc (two ampules) of Sublimaze to the patient Halstead at 11:30 a.m. The Respondent failed to turn in or account for three ampules of Sublimaze drawn at 6:45 p.m. On 03/04/81, the Respondent had signed out to her a total of eight ampules of Sublimaze for the patient Brown. She administered 5 cc (three ampules) to Brown. The Respondent failed to turn in or account for three ampules of Sublimaze. On or about March 4, 1981, the Respondent was discharged from Bayfront. The Administrative Complaint in this cause was issued on September 24, 1981. At the request of the Respondent, the final hearing in this matter was continued on three occasions: March, November and December 1982. Since the filing of the Administrative Complaint, the Respondent has been unable to work in her profession due to the unresolved charges against her. She has been employed as a secretary since 1981 and has suffered significant reduction in her income.
Recommendation Having found the Respondent guilty of one count of violating Section 464.018(1)(f), Florida Statutes, and considering that she has been effectively denied the right to practice for two years, it is recommended that the Respondent, Carolyn Wilder, be permitted to return to practice and placed on probation for one year. DONE and RECOMMENDED this 30th day of July, 1983, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, 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 30th day of July, 1983. COPIES FURNISHED: W. Douglas Moody, Jr., Esquire 119 North Monroe Street Tallahassee, Florida 32301 Robert W. Pope, Esquire 689 Central Avenue, 2nd Floor St. Petersburg, Florida 33701 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Helen P. Keefe, Executive Director Board of Nursing Ill East Coastline Drive, Room 504 Jacksonville, Florida 32202
The Issue The issues for determination are whether Respondent Bernard Zaragoza, M.D., violated Section 456.072(1)(bb), Florida Statutes (2007), as alleged in an Administrative Complaint filed by the Department of Health before the Board of Medicine on June 30, 2008; and, if so, what disciplinary action should be taken against his license to practice medicine in the State of Florida.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. § 20.43 and Chs. 456 and 458, Fla. Stat. Respondent, Bernard J. Zaragoza, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 67920. Dr. Zaragoza’s address of record is 3100 Coral Hills Drive, Suite 207, Coral Springs, Florida 33065. Dr. Zaragoza is certified in general surgery by the American Board of Surgery. Dr. Zaragoza has not been the subject of any investigation, claim, or complaint relating to his professional career other than this matter. Dr. Zaragoza graduated, Summa Cum Laude, from the University of Miami with a bachelors degree. He earned his medical degree from Harvard Medical School. Dr. Zaragoza performed a five-year surgical residency program at New York Medical College’s Westchester County Medical Center. During his residency, Dr. Zaragoza performed hundreds of laparoscopic procedures, including laparoscopic cholechstectomies (removal of the gallbladder). A laparoscopic surgery is a technique in which the abdomen is entered through small incisions rather than “opening up” the abdomen. Normally, for abdominal laparoscopic surgery, incisions are made at the belly button. This is the point which is usually closest to the peritoneal cavity, thus reducing the distance from the skin the surgeon must work through and the surgeon has a broader view of the abdomen. By October 2007, Dr. Zaragoza had performed in excess of 2,000 laparoscopic cholecystectomy procedures. Patient J.C. On October 1, 2007, Patient J.C., a male, 83 years of age, presented at Northwest Medical Center, located in Margate, Florida, for treatment of abdominal pain and vomiting. Patient J.C. had reported with the same symptoms a month earlier and had been diagnosed with chronic cholecystitis, a chronic inflammation of the gallbladder due to the blockage of the bile ducts by gall stones. It is a life-threatening condition. Patient J.C. was admitted by Rafael Rodriguez, M.D., who requested a consultation by Mark Shachner, M.D., Dr. Zaragoza’s partner. Dr. Shachner confirmed a diagnosis of acute cholecystitis and, in light of the failed conservative therapy which Patient J.C. had undergone since his first visit and the potential threat to his life, Dr. Shachner recommended surgery. It was concluded that Patient J.C. would undergo an attempted laparoscopic cholecystectomy. Dr. Zaragoza was to perform the procedure. It was concluded that a laparoscopic procedure was the appropriate procedure for Patient J.C. due to his medical history: atrial fibrillation, Alzheimer’s disease, hypertension, and diabetes. He had also undergone prior abdominal procedures. The parties did not dispute that a laparoscopic procedure, because it was likely to reduce post- operative complications, was the best type of surgical procedure for Patient J.C. Patient J.C., as a result of a prior gastrectomy, had a long midline incision extending from the Xiphoid upper abdomen to below the belly button. As a result of this surgery, Patient J.C. had extensive adhesions of tissue up to the midline. Patient J.C. had also undergone an appendectomy. It was concluded that, due to Patient J.C.’s condition and abdominal surgical history, rather than entering at the belly button and risking injury to any structures that were adhesed to the midline, a “right-sided” incision point would be used. The Department does not dispute the appropriateness of this decision. Unfortunately, by using a right-sided incision point, Dr. Zaragoza’s visualization of Patient J.C.’s abdominal cavity was reduced. Patient J.C. and his family were fully informed of the nature of the proposed surgical procedure and the risks, after which Patient J.C. signed a written consent for surgery. The written consent included an authorization to “take whatever action(s) and to perform whatever procedures(s) they deem necessary and advisable, which may be in addition to or different from those now planned” and an acknowledgement that the surgery to be performed “may result in perforation or injury to adjacent organs or structures.” None of the witnesses convincingly testified that the authorization included the authority to remove healthy organs or that the acknowledgement included any suggestion that a healthy organ might be completely removed. Surgery was scheduled for October 2, 2007. Dr. Zaragoza began the surgery with a right-sided approach, freeing up the area and attempting to identify important structures in the right upper quadrant of the abdomen. In particular, the important structures Dr. Zaragoza attempted to locate were the liver, colon, and the gallbladder. Dr. Zaragoza encountered extremely heavy adhesions (8 on a scale of 1 to 10) in Patient J.C.’s abdomen. Dr. Zaragoza considered the risks of continuing or switching to an open abdomen procedure and correctly concluded it was best to proceed. Dr. Zaragoza freed up extensive adhesions and was able to correctly identify the liver. Unable to identify the gallbladder and due to the extensive adhesions in the area of the intestine, Dr. Zaragoza stopped the procedure in order to retrieve a CT scan of the area and personally evaluate the images. In order to expedite receipt of the CT study, Dr. Zaragoza scrubbed out and personally walked to the radiology suite. After returning, Dr. Zaragoza read the CT scan and the radiologist’s interpretation, which indicated that the gallbladder was posterior to the transverse colon. Dr. Zaragoza returned to Patient J.C., mobilized the colon to free it from the liver and attempted to locate the gallbladder behind the colon where he expected it to be. What Dr. Zaragoza found behind the transverse colon was a dark, thickened, and solid structure in the anatomical position which the CT scan and radiologist report suggested the gallbladder would be located. While the gallbladder, which consists of a water sac, is normally soft, pink, and pliable, this is not the case with an inflamed and infected one. Given Patient J.C.’s history of chronic cholecystitis with an acute cholecystitis secondary to the blockage of bile ducts by gallstones, Dr. Zaragoza was expecting to find a dark, thickened, and solid gallbladder in Patient J.C. Concluding that the structure he had located was the gallbladder, Dr. Zaragoza freed the organ of surrounding tissue, freeing away without incision adhesions to the organ, bringing the organ into position for removal. As Dr. Zaragoza began to free up the fat tissue around what he believed were the bile duct and blood vessels of the gallbladder, the organ ruptured, revealing a solid mass. Dr. Zaragoza believed that the mass was a tumor, which Dr. Zaragoza had encountered in other gallbladder surgeries. Dr. Zaragoza continued the procedure, separating the gallbladder for removal. While dividing what he believed was a cystic duct, Dr. Zaragoza encountered a bifurcation that did not correspond to the anatomy of the gallbladder. At this point, Dr. Zaragoza decided that surgery needed to be converted from laparoscopic to an open procedure. After doing so, a frozen section of the organ was sent to pathology for evaluation, in order to obtain a rapid evaluation of the tissue. The pathology report revealed that the organ that Dr. Zaragoza had removed from Patient J.C. was a healthy kidney. Dr. Zaragoza thereupon located the gallbladder by examining the dense adhesions around the colon, a risky procedure. Ultimately Dr. Zaragoza was required to cut into the transverse colon where he located the gallbladder, which had eroded into the transverse colon. Dr. Zaragoza then completed the surgical procedure, removing the gallbladder. Patient J.C.’s family was immediately advised of what had taken place; that Dr. Zaragoza had removed a kidney, in addition to successfully removing the gallbladder. The removal of a healthy kidney involves a medical procedure totally unrelated to removal of an unhealthy gallbladder. Removal of a healthy kidney is not a known or expected complication of gallbladder removal. Dr. Zaragoza’s removal of Patient J.C.’s kidney during gallbladder surgery constituted a “a wrong-site procedure, wrong procedure, or an unauthorized procedure, or a procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition.” The Department’s proposed findings of fact 12 through 20 contained in the Department’s Proposed Recommended Order, are accurate, support the ultimate findings of fact made in this paragraph and are subordinate thereto. Proposed findings of fact 36 through 38 of Respondent’s Proposed Order in large part accurately reflect the difficulty of the surgery performed on Patient J.C. Even the Department’s own expert noted that he thanked God Patient J.C. had not been his patient. The suggestion in paragraph 26 that the removal of the kidney was “simply an unwanted complication associated with this cholecystectomy procedure” is, however, not supported by the weight of the evidence.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Board of Medicine finding that Bernard J. Zaragoza, M.D., has violated Section 456.072(1)(bb), Florida Statutes, as alleged in the Administrative Complaint; imposing a fine of $5,000.00; issuing a letter of concern; requiring the completion of five hours of risk management education; and requiring that he perform 50 hours of community service. DONE AND ENTERED this 6th day of April, 2010, in Tallahassee, Leon County, Florida. LARRY J. SARTIN 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 6th day of April, 2010. COPIES FURNISHED: Rolando A. Diaz, Esquire Kubicki & Draper 25 West Flagler Street, Penthouse Miami, Florida 33130 Robert A. Milne, Esquire Department of Health Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Diane K. Kiesling, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-3265 Dr. Ana M. Viamonte Ros, Secretary Department of Health 4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701 Josefina M. Tamayo, 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
Findings Of Fact At all material times, Respondent has been a licensed physician, holding Florida license number ME 0047032. In June 1988, Respondent worked as an emergency room physician at East Point Hospital emergency room. He had been so employed since 1987. At 11:26 pm on June 10, 1988, the wife of A. L., a 71 year old male, summoned an ambulance for her husband, who had been suffering from severe headaches and vomiting. He was transported by ambulance to the East Point Hospital emergency room at 11:55 pm. The notes of the admitting nurse state that A. L.'s headache started about 9 pm and he had vomited twice at home, but without signs of bleeding or diarrhea. He vomited once at the hospital and had a history of five heart attacks. The stated patient complaint is severe headache. The vital signs were normal. The admitting notes record that A. L. was taking numerous medications. Of particular importance is Coumadin, which is an anticoagulant whose chief side effect is bleeding. There is an increased risk of intracranial bleeding associated with the use of Coumadin. Respondent's notes record a frontal headache of three to four hours' duration with intermittent sinus problems for several months. The notes reflect a physical examination that disclosed some tenderness over frontal and maxillary sinuses, which are above and below the eyes. Respondent did not perform a neurological examination. A neurological examination is an examination of the cranial nerves, including the nerves of the eyes and head, and an assessment of motor strength and reflexes. Respondent claims to have performed a neurological examination and also that an examination of the eyes was precluded by recent cataract surgery. He testified that he did not document the neurological examination because the vital signs were good, the patient was alert and cooperative, and the problem was a sinus headache. As to checking motor strength, Respondent testified, "I did check his extremities. I think he was moving around." Respondent's claim to have performed an undocumented neurological examination is uncredited. Even if eye surgery precluded an examination of the eyes, Respondent did not examine other nerves of the head. Nor did he even claim to have tested reflexes. His claim to have tested motor strength is based on the assertion, "I think he was moving around." Motor strength involves more than self-ambulation. Respondent's failure to perform a neurological examination constituted a failure to practice medicine with the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions. Following his examination of A. L., Respondent observed A. L. for about an hour. When A. L. reported he was feeling better, Respondent allowed A. L.'s wife to take him home with instructions to return if there were more problems. Respondent's diagnosis was sinusitis with headache, and he prescribed 50 mg of Demerol for pain. About an hour and a half after discharge, A. L. fell into a stupor. Returned to the hospital in an ambulance, A. L. was in an unresponsive state. Subsequent testing revealed that he had suffered a subdural hematoma and intracerebral hemorrhage. He died a week later. Petitioner did not prove that Respondent's failure to order a CT scan was a violation of the minimum standard of care. A. L. had a long history of sinus problems. The severe headache and use of Coumadin were not, of themselves, sufficient cause to mandate a CT scan without implying that all patients taken to the emergency room complaining of severe headaches must be given CT scans. Respondent's failure to perform a neurological examination and misdiagnosis probably had no bearing on A.L.'s prognosis. Intracranial bleeding is not susceptible to surgical correction, although a subdural hematoma is. In fact, the neurological exam might not have clearly indicated the presence of the intracranial bleeding, although, properly interpreted, it should have indicated the necessity of a CT scan, which typically would indicate the presence of intracranial bleeding. There is no evidence whatsoever that any delay in bringing the case to the Probable Cause panel or filing the Administrative Complaint had any prejudicial impact upon Respondent.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order imposing an administrative fine against Respondent of $5000. ENTERED on May 18, 1995, in Tallahassee, Florida. ROBERT E. MEALE Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings on May 18, 1995. APPENDIX Rulings on Petitioner's Proposed Findings and 3: rejected as irrelevant. and 4-25: adopted or adopted in substance. 26-30: rejected as unsupported by the appropriate weight of the evidence, irrelevant, and unnecessary. 31: adopted. 32: rejected as repetitious. 33-36: rejected as irrelevant except that an intracerebral hemorrhage is an inoperable condition. Rulings on Respondent's Proposed Findings All rejected as not findings of fact, irrelevant, unsupported by the record, and legal argument. COPIES FURNISHED: Dorothy Faircloth, Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, FL 32399-0792 Attorney Joseph S. Garwood Agency for Health Care Administration 1940 N. Monroe St., Ste. 60 Tallahassee, FL 32399-0792 Dr. Rufus Paul Palmer 5581 Amoroso Drive Ft. Myers, FL 33919
The Issue The issue in this case is whether Respondent, Andrew Logan, M.D., committed a violation of Section 458.331(1)(t), Florida Statutes, as alleged in an Administrative Complaint filed by Petitioner, the Department of Health, on April 30, 2003, and, if so, what disciplinary action should be taken against him.
Findings Of Fact The Parties. Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. Respondent, Andrew Logan, M.D., is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 0058658. Dr. Logan's last known business address is 8551 West Sunrise Boulevard, Suite 105, Plantation, Florida 33322. At the times material to this matter, Dr. Logan was certified in ophthalmology. He specializes in medical and surgical ophthalmology. Dr. Logan received a bachelor of arts degree in biology in 1982 from Brown University. He received his medical degree in 1986 from the University of California, San Francisco.2 Dr. Logan completed a residency in ophthalmology. Dr. Logan has practiced medicine in Florida since 1990. At the times relevant to this matter, Dr. Logan worked in a group practice in Plantation, Florida. Most of his practice consisted of an office practice, seeing patients. He also performed some laser and minor surgeries in the office. Approximately once a week, for half a day, he performed surgery out of the office at "three hospitals and surgical centers." Dr. Logan's license to practice medicine has not been previously disciplined. The Department's Administrative Complaint and Dr. Logan's Request for Hearing. On April 30, 2003, the Department filed an Administrative Complaint against Dr. Logan before the Board of Medicine (hereinafter referred to as the "Board"), alleging that his treatment of one patient, identified in the Administrative Complaint as C. S., constituted gross or repeated malpractice or the failure to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances (the recognized acceptable treatment will hereinafter be referred to as the "Standard of Care"), a violation of Section 458.331(1)(t), Florida Statutes. In particular, it is alleged in the Administrative Complaint that Dr. Logan violated the Standard of Care in "one or more of the following ways": Respondent failed to identify the correct patient for the implantation of the 23 diopter lens; Respondent failed to verify that the lens he implanted into Patient C.S. was the power of lens that he had previously ordered; Respondent implanted the wrong lens into the left eye of Patient C.S. The factual allegations of the Administrative Complaint, although stated differently, essentially allege that Dr. Logan operated on the wrong patient. Dr. Logan filed a request for a formal administrative hearing with the Department, which was filed by the Department with the Division of Administrative hearings. Treatment of Patient C.S. C.S., who was 70 years of age at the time of the incident involved in this matter, began seeing Dr. Logan for eye care in approximately February 1997. C.S. developed cataracts in both eyes, for which Dr. Logan diagnosed and suggested surgical treatment.3 Dr. Logan explained the procedure he believed necessary to remove C.S.'s cataracts to her and obtained her approval thereof. The procedure to be performed on C.S., known as phacoemulisification, consisted of making an very small incision in her eye, breaking up her natural, or intraocular, lens with ultrasound, irrigating the eye, and then suctioning out the destroyed lens and irrigation material. Once the intraocular lens is removed, it is replaced with an artificial lens, the power and model of which is selected by the physician. Dr. Logan determined that the lens needed to restore C.S.'s vision in her left eye after removal of her intraocular lens was a 15-diopter lens. The "diopter" of a lens relates to the corrective power of the lens. C.S. was scheduled for the planned cataract surgery on her left eye at the Surgery Center of Coral Springs (hereinafter referred to as the "Surgery Center") for the morning of September 5, 2000.4 C.S. was one of at least two patients scheduled for surgery by Dr. Logan that morning. The Surgery Center is a free-standing center where various types of surgery are performed. Dr. Logan was not an owner or employee of the Surgery Center. He did not hire, nor could her fire, any employee of the Surgery Center, and none of the equipment utilized in the Surgery Center was owned by him.5 Consistent with established procedures, the Surgery Center was faxed information concerning C.S.'s scheduled surgery. In particular, the facsimile identified C.S. by name, which eye was to be operated on (her left eye), and the power (15-diopter) and model number of the replacement lens Dr. Logan had determined was necessary to restore C.S.'s vision after the surgery. The day before C.S.'s scheduled surgery, Dr. Logan was provided with C.S.'s patient records and the records of the other patient scheduled for surgery on September 5, 2000. He reviewed those records either that afternoon or that night. He also took the records with him to the Surgery Center where he reviewed them again. On or around the morning of September 5, 2000, the Surgery Center's nurse manager took the facsimiles that had previously been sent to the Surgery Center by Dr. Logan's office and retrieved the lens for each patient scheduled for surgery that day. When the nurse manager retrieved the lens, she was expected to ensure that the ordered lens, both as to power and model, were available, and that they were within their expiration date. She then bundled the lens and the facsimile. Three lens per patient were routinely retrieved. The bundles were then placed on a table in the operating room in the order they were supposed to be used. The order of surgery for September 5, 2000, had been prearranged and that information was available on a list prepared by the Surgery Center to all of those involved in the surgery that morning, including Dr. Logan and his surgery team. C.S. had been scheduled to be the second patient seen that morning. When C.S. arrived at the Surgery Center she was eventually taken to a pre-operation room (hereinafter referred to as "pre-op") to be readied for surgery. The patient who had been scheduled for the first surgery of the morning (hereinafter referred to as the "First Scheduled Patient"), had been late arriving on September 5, 2000. C.S. had come early. Therefore, C.S. was taken to pre-op in place of the First Scheduled Patient. What exactly transpired after C.S. was taken to pre-op was not explained. The nurse manager, who had overall responsibility for getting patients ready for surgery did not testify during this proceeding and the circulating nurse, Ann Tuza, was unable to recall what took place in any detail. What was proved is that Dr. Logan was not informed of the switch and the records and lens, which had been placed in the order of the scheduled surgeries for that day, were not changed to reflect that C.S. would be taken to surgery in place of the First Scheduled Patient. Therefore, although C.S. was the first patient into surgery, the records and lenses of the First Scheduled Patient were not replaced with C.S.'s records or lens. As was his practice, before going into the operating room, Dr. Logan went to pre-op to administer a local anesthesia. Dr. Logan, who had not been informed that the second scheduled patient, C.S., had been substituted for the First Scheduled Patient, administered the anesthesia to C.S. Dr. Logan found C.S. asleep. Dr. Logan did not recognize C.S. and he did not speak to her, as would have been his practice had she been awake, or otherwise identify her. Dr. Logan injected a local anesthesia by needle under and behind C.S.'s left eye,6 a procedure referred to as a "block" or "retrobulbar block."7 After the block had time to take effect, which normally took approximately five to ten minutes, Nurse Tuza went to retrieve C.S. from pre-op and bring her to the operating room. C.S. was brought into the operating room by Nurse Tuza and prepared for surgery. She was covered completely except for her feet and her left eye, which had an "X" placed over it to identify the eye to be operated on. Nurse Tuza remained in the operating room, along with a scrub technician, who assisted Dr. Logan, and a nurse anesthetist. None of these individuals apparently checked to ensure that they were correct in their assumption that the patient was the First Scheduled Patient. Dr. Logan, who did not recall what he did between seeing C.S. in pre-op and arriving at the operating room, completed scrubbing and entered the operating room where C.S. awaited. He had placed his charts in the operating room. His routine after arriving in the operating room was to go to the head of the patient and adjust a microscope used during the surgery. It is inferred that he did so on the morning of September 5, 2000. Although C.S. was awake when she was taken into the operating room and during the surgery, no one, including Dr. Logan, asked her her name. Nor did anyone, including Dr. Logan, check to see if she was wearing a wrist-band which identified her. Instead everyone, including Dr. Logan, assumed that they were operating on the First Scheduled Patient. Not actually knowing who he was operating on,8 Dr. Logan performed the surgery scheduled for the First Scheduled Patient on C.S. Although the procedure her performed on C.S., fortunately, was the same one scheduled for C.S., the diopter of the replacement lens was not.9 The First Scheduled Patient was to receive a 23-diopter lens, rather than C.S.'s 15- diopter lens. Dr. Logan placed the 23-diopter lens in C.S.'s eye, completed the procedure, and C.S. was taken to recovery. When Nurse Tuza went to get the next patient for surgery, who she expected to be C.S., she discovered for the first time that C.S. had been substituted for the First Scheduled Patient. She immediately informed Dr. Logan of the error. Dr. Logan went to the recovery room and, after ensuring that C.S. was alert enough to comprehend what he was saying, informed C.S. of the error. She consented to Dr. Logan's suggestion the he take her back into the operating room, remove the 23-diopter lens, and replace it with the correct, 15-diopter lens, which he immediately did. The replacement procedure required no additional trip to the Surgery Center, anesthesia, or incisions. C.S. recovered from the procedures without problem or direct harm. She continued to see Dr. Logan as her eye care until a change in insurance prevented her from doing so. Standard of Care. There was little dispute that Dr. Logan "failed to identify the correct patient for the implantation of the 23 diopter lens"; "failed to verify that the lens he implanted into Patient C.S. was the power of lens that he had previously ordered [for her]"; and "implanted the wrong lens into the left eye of Patient C.S." These facts, which form the factual basis for the Department's allegation that Dr. Logan violated the Standard of Care, have been proved. Including Dr. Logan, five physicians gave opinions in this proceeding as to whether Dr. Logan's actions violated the Standard of Care: Drs. William Cobb, Harry Hamburger, Joel Kramer, and Lowell Sherris. The testimony of Drs. Cobb and Kramer, primarily, and, to a lesser degree, the testimony of the Dr. Logan and the other two physicians, support a finding that Dr. Logan's actions, as alleged in the Administrative Complaint, constitute a violation of the Standard of Care. The testimony of Drs. Cobb, Kramer, and Sherris, which was credible and persuasive, have been summarized in the Department's proposed recommended order, and will not, in light of recent changes in Section 456.073(5), Florida Statutes, be summarized in any detail here. All of the physicians who testified, including Dr. Logan, agreed that a physician must know on whom he or she is operating and that operating on the wrong patient or inserting the wrong lens in a patient's eye is inappropriate. Dr. Logan, with Dr. Hamburger's support, attempted to prove that Dr. Logan did not violate the Standard of Care, despite the fact that he "failed to identify the correct patient for the implantation of the 23 diopter lens"; "failed to verify that the lens he implanted into Patient C.S. was the power of lens that he had previously ordered [for her]"; and "implanted the wrong lens into the left eye of Patient C.S.," by suggesting the following: It is reasonable and common practice in the South Florida community for a physician to rely on the staff of a surgical center to identify a patient prior to surgery and bring the patients [sic] back in the order originally anticipated. Dr. Logan had several safeguards in place to avoid the error that occurred in this case. The standard of care does not require that physician act as a supervisor who is responsible for every act of the healthcare provided team. This incident occurred due to an error of the staff at the Surgical Center at Coral Springs. . . . . Respondent's Proposed Final [sic] Order, paragraph 78. The proposed findings quoted in paragraph 37 are based primarily on Dr. Hamburger's, and to a lesser extent, Dr. Logan's, assertion that the surgery was a team effort, that the team had established procedures to identify the patient, and that the team failed in this instance to properly identify the patient. This testimony, and the proposed findings quoted in paragraph 37 are rejected. Nothing in the procedures followed in this instance alleviated Dr. Logan's responsibility to ensure that he actually established for himself who he was about to perform surgery on, a task which would have taken little effort.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the a final order be entered by the Board of Medicine finding that Andrew Logan, M.D., has violated Section 458.331(1)(t), Florida Statutes (2000), as alleged in the Administrative Complaint, requiring the payment of an administrative fine of $5,000.00, completion of four hours of continuing medical education in risk management, and attendance at a one hour lecture on wrong patient surgery and how to avoid it, and issuing Dr. Logan a letter of concern from the Board of Medicine. DONE AND ENTERED this 19th day of February, 2004, in Tallahassee, Leon County, Florida. S LARRY J. SARTIN 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 February, 2004.
The Issue Whether Petitioner is entitled to a Certificate of Need ("CON") authorizing establishment of an (ophthalmological) ambulatory surgical center in Palm Beach County, Florida. Subordinate issues are: Whether the proposed facility satisfies the CON criteria of Sections 381.494-499, Florida Statutes, as implemented by Respondent, Department of Health and Rehabilitative Services ("HRS) rule and non-rule policy; Whether the proposed facility will result in unnecessary duplication of services, underutilization of existing services and increased health care costs to the community; Whether adequate resources are available for the construction and operation of the proposed facility; and Whether the proposed facility is financially feasible.
Findings Of Fact (Numbering corresponds to numbering used in proposed findings.) Preliminary findings: 1-4. Approved. On issue of compliance with applicable criteria: 1-7. Approved. 8. Approved, with caveat that this is subject to supplying an adequate record basis for the policy at hearing. 9-13 Approved. Approved but no presumption of correctness attaches to HRS earlier or more recent evaluation of the application. See, Boca Raton, supra. Approved. Approved but modified to more accurately reflect that HRS takes HMO's into account, but this factor was not used or relied on (in connection with the non-rule policy or standing alone) as the basis for granting Petitioner's application. Approved. 18-32. Approved, in the sense that an HRS expert witness at hearing offered conclusions as to compliance with each statutory criteria; rejected, in that his conclusions (except for those concerning quality of care, financial feasibility, the inapplicability of some criteria, and the cost advantages of modifying an existing facility instead of constructing a new one) are rejected as unsubstantiated by the facts. On the Issue of Need: 1-8. Approved. Approved. Modified to reflect that this is one estimate among several offered by experts. Rejected as unsupported by the credible evidence of record. Approved. Approved. First sentence, approved, in that this is the stated "attempt" of HRS' challenged non-rule policy. Second sentence, rejected as unsupported by the credible evidence; the profitable performance of outpatient surgery at a physician's office does logically compel a conclusion that his office should be licensed as an ambulatory surgical facility. On the issue of adequate resources: 1-8. Approved. On the issue of financial feasibility: 1-19 Approved. 20. Rejected as argumentative. RULINGS ON INTERVENOR'S PROPOSED FINDINGS 1-4. Approved. 5. Approved except for reference to equipment costs, of which there will be none. 9-16 Approved. 17. Such broad-brush incorporation of all facts asserted in argument is not susceptible to explicit rulings. RULINGS ON POST-HEARING MOTIONS. Intervenor's "Motion to Stay Issuance of Recommended Order" is denied. Intervenor's "Request for Hearing Officer to Take Official Recognition" of the Final Order of Hearing Officer Robert T. Benton II, in consolidated DOAH Case Nos. 85-2962R, 85-2963R and 85-3193R (attached to a "Notice of Supplemental Authority" dated November 1, 1985) is granted. The order is made a part of the record of this proceeding. A final order entered by another hearing officer of the Division of Administrative Hearings the authenticity of which is not in question, is an appropriate document to be accorded official recognition. See, Health Quest Realty XII v. HRS, 10 FLW 1729 (Fla. 1st DCA July 16, 1985, pet. for reh. pending). COPIES FURNISHED: Eric B. Tilton, Esquire 104 S. Monroe St. Tallahassee, Florida 32301 Theodore E. Mack, Esquire 1323 Winewood Blvd. Tallahassee Florida 32301 William B. Wiley, Esquire Post Office Box 2174 Tallahassee, Florida 32316
Recommendation Based on the foegoing it is RECOMMENDED: That Petitioner's application for a CON authorizing establishment of an ambulatory surgical facility at his offices in Palm Beach County, Florida, be DENIED. DONE and ORDERED this 15th day of January, 1986, in Tallahassee Florida. R. L. CALEEN, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee Florida 32301 (904)488-9675 Filed with the Clerk of the Division of Administrative Hearings this 15th day of January, 1986.
