Findings Of Fact St. Mary's Hospital, Inc. ("St. Mary's"), is a certificate of need ("CON") applicant for an adult open heart surgery program in Department of Health and Rehabilitative Services ("HRS"), District IX. The Agency for Health Care Administration ("AHCA") is the state agency responsible for the administration of CON laws. Intervenor, Martin Memorial Hospital Association, Inc., d/b/a Martin Memorial Medical Center ("Martin Memorial") has standing to intervene as a CON applicant for an open heart surgery program in HRS District IX. Intervenors, JFK Medical Center, Inc., ("JFK") and Palm Beach Gardens Community Hospital, Inc., d/b/a Palm Beach Gardens Medical Center ("Palm Beach Gardens") have standing to intervene as existing providers of open heart surgery services in HRS District IX. AHCA published a net need projection for zero additional adult open heart surgery programs in HRS District IX, with the following notice: Any person who identifies any error in the fixed need pool numbers must advise the agency of the error within ten (10) days of publication of the number. If the agency concurs in the error, the fixed need pool number will be adjusted prior to or during the grace period for this cycle. Failure to notify the agency of the error during this ten day time period will result in no adjustment to the fixed need pool number for this cycle and a waiver of the person's right to raise the error at subsequent proceedings. See, Volume 18, Number 32, Florida Admiministrative Weekly, at page 4501 (August 7, 1992). By letter dated August 14, 1992, St. Mary's notified AHCA that it believed an error had been made in the fixed need pool projection for adult open heart surgery programs in HRS District IX. This letter was hand delivered to AHCA on August 14, 1992, within the ten days required by the fixed need pool publication. All of the parties to this proceeding agree with St. Mary's that the numeric need formula in Rule 10-5.033(7), Florida Administrative Code (subsequently, renumbered as Rule 59C-1.033(7), showed a need for one additional adult open heart surgery program in District IX, except that AHCA determined that the provisions of subsection 7(a)2. were not met. St. Mary's letter also asserted that there was evidence that all existing adult open heart surgery providers performed in excess of 350 adult open heart surgery operations during the applicable base period calendar year 1991. The minimum of 350 operations in each existing program is an additional prerequisite to the publication of need for a new open heart surgery program in subsection 7(a)2. of Rule 59C-1.033, which the parties refer to as a "default" provision. The default provision is invoked in this case because JFK reported fewer than 350 operations. The subsection provides that a new adult open heart surgery program will not normally be approved if: One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 6 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 350 adult open heart surgery operations during the 12 months ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. (Emphasis added). In its letter of August 14, 1992, St. Mary's stated that: According to the information provided by JFK to the local health council JFK performed 347 adult open heart surgery operations during the applicable base period (calendar year 1991). Notwithstanding the data reported by JFK to the local health council, data obtained from the Health Care Cost Containment Board for the same 12 month period reflects a total of 356 adult open heart surgery discharges from JFK. All parties agree that for calendar year 1991, JFK Medical Center, Inc. ("JFK"), reported a total of 356 discharges within DRG's 104 through 108 to Florida's Health Care Cost Containment Board and, for the same period of time, JFK reported 347 adult open heart surgery operations to the Treasure Coast Health Council, Inc. Based on the data provided by JFK to the HCCB, St. Mary's requests that AHCA enter a final order finding that there is a need for one additional open heart surgery program in District IX in the September, 1992 review cycle. The determinative factual issue, in this proceeding, is whether the term "discharge" is equivalent to the term "operation" and, if it is, should the HCCB data be accepted as more reliable than the Health Council data. The term "open heart surgery operation" is defined by Rule 59C- 1.033(2)(g), Florida Administrative Code, to mean: Surgery assisted by a heart-lung by-pass machine that is used to treat conditions such as congenital heart defects, heart and coronary artery diseases, including replacement of heart valves, cardiac vascularization, and cardiac trauma. One open heart surgery operation equals one patient admission to the operating room. Open heart surgery operations are classified under the following diagnostic related groups (DRGs): DRGs 104, 105, 106, 107, 108, and 110. (Emphasis added). The definition of "open heart surgery operation" was also considered in Humhosco, Inc. v. Department of Health and Rehabilitative Services, 14 FALR 245 (DOAH 1991). The hearing officer found that: [D]iagnostic related groups, or "DRGs," are a health service classification system used by the Medicare System. The existing rule does not include the reference to DRG classifications. Some confusion had been expressed by applicants as to whether certain organ transplant operations which utilized a bypass machine during the operation should be reported as open heart operations or as organ transplantation operations. The amendment was intended to clarify that only when the operation utilizes the bypass machine and falls within one of the enumerated categories should it be considered an open heart surgery operation. The inclusion of the listed DRGs was meant to clarify the existing definition by limiting the DRG categories within which open heart surgery services may be classified. There is no dispute that the primary factor in defining an open heart surgery procedure is the use of a heart-lung machine. Florida Hospital argued that the proposed definition is ambiguous and vague because not all procedures which fit into the listed DRG categories necessarily involve open heart surgery. Florida Hospital's fear that the new language would seem to indicate that each procedure falling into the listed DRGs qualifies as an open heart surgery operation is unfounded. While the provision could have been written in a simpler and clearer manner, the definition adequately conveys the intent that the use of a heart-lung bypass machine is an essential element to classify an operation as open-heart surgery. Humhosco, supra, at 255. (Emphasis added).
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order determining that the fixed need pool publication, dated August 7, 1992, for Department of Health and Rehabilitative Services District IX for the July 1994 planning horizon is accurate. DONE and ENTERED this 22nd day of December, 1992, at Tallahassee, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of December, 1992. APPENDIX Both parties have submitted Proposed Recommended Orders. The following constitutes my rulings on the proposed findings of fact submitted by the parties. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Accepted in Findings of Fact 5 and 6. Subordinate to Findings of Fact 13. Accepted in Findings of Fact 11, conclusion rejected in Findings of Fact 13-15. Accepted in Findings of Fact 15, conclusion rejected in Conclusions of Law 18-19. Rejected in Conclusions of Law 17-19. Rejected in Findings of Fact 13-15. Accepted in Conclusions of Law 1. Accepted in Findings of Fact 7 and 9. Accepted in Findings of Fact 7 and 9. Accepted, in part, and rejected, in part in Findings of Fact 10 and 11. Rejected in Findings of Fact 11 and 13-15. The Respondent's Proposed Findings of Fact Proposed Finding Paragraph Number in the Findings of Fact of Fact Number in the Recommended Order Where Accepted or Reason for Rejection. Accepted in Findings of Fact 5. Accepted in Findings of Fact 5. Accepted in Findings of Fact 6. Preliminary Statement Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Preliminary Statement. Accepted in Findings of Fact 7 and 9. Accepted in Findings of Fact 10 and 11. Accepted in relevant part in Findings of Fact 4. Subordinate to Findings of Fact 9 and 11. Subordinate to Findings of Fact 7. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Subordinate to Findings of Fact 12. Subordinate to Finding of Fact 11. Accepted in Conclusions of Law 17. Accepted in Findings of Fact 13-15. Accepted in Findings of Fact 13-15. COPIES FURNISHED: W. David Watkins, Esquire Oertel, Hoffman, Fernandez & Cole, P.A. 2700 Blair Stone Road Tallahassee, Florida 32301 Lesley Mendelson, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308 Byron B. Mathews, Jr., Esquire 201 S. Biscayne Boulevard Suite 2200 Miami, Florida 33131 Gerald M. Cohen, P.A. Steel Hector & Davis 4000 Southeast Financial Center Miami, Florida 33131-2398 Robert A. Weiss, Esquire John M. Knight, Esquire Parker, Hudson, Rainer & Dobbs The Perkins House 118 N. Gadsden Street Tallahassee, Florida 32301 Sam Power, Agency Clerk Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Harold D. Lewis, General Counsel Agency for Health Care Administration The Atrium, Suite 301 325 John Knox Road Tallahassee, Florida 32303
Findings Of Fact Stanley E. Ross, D.D.S. is licensed to practice dentistry in Florida, and at all times relevant herein was so licensed. His practice is limited to periodontics and Ross is a board certified periodontist. In 1975 Ross was associated with the Professional Association owned by Dr. Marvin M. Rosenberg, also a board certified periodontist. Offices were occupied in Boca Raton and West Palm Beach with each dentist spending part of each week at each office. Although they practiced under the same roofs it was very infrequent one would treat a patient of the other. Nathan Wolfson, a 61 year old retiree, was referred to Rosenberg and Ross for examination and possible periodontal treatment by Dr. Medoff, a dentist engaged in general practice. Following routine pre-operative procedures, extensive periodontal surgery was performed by Ross on Wolfson on Friday, November 7, 1975. Numerous incisions were made in the gums, tissue and bone was removed, and the tissue sutured back to the jaw. The operation lasted three to four hours and Wolfson departed the dental office ambulatory. Ross had prescribed Percodan for Wolfson to take for pain expected following the extensive surgery. On Sunday Wolfson began experiencing pain in the neck and across the shoulders and his wife called Ross. When the latter inquired and was advised that Wolfson was not taking the Percodan that had been prescribed Ross told her that the medication had been given him to take care of the pain and to start using them. Sunday night or Monday morning part of the packing fell out and on Monday Wolfson went to the Boca Raton office to have this replaced. Ross was not in the Boca Raton Office that day and a dental hygienist replaced the packing. One witness testified that Dr. Rosenberg was seen coming out of the operatory with Wolfson and was overheard telling Wolfson that the pain in his neck and across the shoulders was very normal following such surgery. Rosenberg denied ever seeing or talking to Wolfson. On Tuesday November 11, 1975 Wolfson was still uncomfortable and again returned to the Boca Raton office. He told one of the dental assistants that he was experiencing pain in the jaw, neck, across the shoulders and "pressure in the chest". She advised him to describe these pains to Ross. Shortly thereafter Ross came in, looked in Wolfson's mouth and listened to Wolfson's complaints of pain in the neck, jaw and across the shoulders. He gave Wolfson 1 cc of Demerol and 1 cc of Tigan, both intramuscular. Ross remained with Wolfson 10 or 15 minutes until the Demerol took effect and Wolfson's pain eased. Wolfson then departed in company with his wife and his wife's sister-in-law. Wolfson occupied the back seat of their car and the two ladies sat in front. Shortly after leaving Ross' office Mrs. Wolfson turned to look back at her husband and saw he was dead. A passing car directed them to Boca Raton Community Hospital where Wolfson was pronounced dead on arrival after emergency resuscitation steps had failed. An autopsy was subsequently performed on Wolfson and the cause of death reported as "coronary insufficiency following severe atherosclerosis of coronary arteries". The right coronary artery was described as showing "more than 95 percent narrowing of the lumen by atherosclerosis 2.0 cm away from the coronary ostium." A medical witness described the autopsy report as showing such extensive cardiovascular disease as to have made Wolfson a poor risk for heart surgery. On September 2, 1975 Wolfson received a physical examination from Dr. Robbins and the EKG taken was considered normal. Other tests performed at this examination were just outside the range of normalcy and Dr. Robbins would have rated Wolfson's physical condition as fair at the conclusion of this examination. He considered Wolfson physically fit for the periodontal surgery performed. Wolfson had a follow-up appointment with Dr. Robbins on November 10, 1975 which was not kept. Mrs. Wolfson, the widow of Nathan, testified that Nathan Wolfson at his November 11, 1975 visit to Ross told Ross that he was experiencing pain in the neck, jaw, back, chest, and down both arms. Ross denied being told of any pain other than in neck and jaw. Shortly after Wolfson's death Mrs. Wolfson and her son visited Dr. Medoff and told him that Wolfson's complaints of pain following his oral surgery was in the back of his neck and shoulder area. No mention was made to Medoff of any pain in the chest or pain radiating down the arms. Boca Raton Community Hospital records of Nathan Wolfson on November 11, 1975 contain the notation "wife states: left dentist office and suddenly had SOB." Again following Wolfson's death, Mrs. Wolfson, in discussing Wolfson's death with Dr. Robbins, mentioned Wolfson having pains following his oral surgery in the jaw and shoulder. She asked Dr. Robbins if pain in the jaw could be from a heart attack and he told her "yes, sometimes." A medical witness specializing in emergency medicine opined that pain in the jaw, neck and across the shoulders four days following extensive oral surgery would not be recognizable as stemming from cardiac problems as all of these symptoms could be attributed to the oral surgery. Another medical witness whose specialty is internal medicine testified it would be extremely unusual for pains across the back and down both arms to lead to medical practitioner to the conclusion the patient was experiencing cardiac failure. He described classic pre-cardia pain to be in chest radiating down left arm. It also can be from chest radiating down the back. He identified pain across shoulders down back and down both arms as that resulting from a dissecting aneurism of the aorta. No evidence, other than Mrs. Wolfson's testimony, showed Ross was ever made aware Wolfson had pain in the chest or pain radiating down either or both arms. As noted above, shortly after Wolfson's death his widow made no mention of pain in chest or arms to the doctor and dentist to whom she spoke. Pain in the jaw can be indicative of cardiac problems when other significant cause for such pain is not present. Here it is obvious there were other significant causes of pain. Three to four hours in the dentist chair with head back, jaws extended having tissue and bone cut away would undoubtedly result in pain in the jaw for several days. From the evidence presented regarding the condition of Wolfson's cardiovascular system as shown by the autopsy performed, it is questionable that Wolfson would have survived even had medical treatment been available and administered at the time he experienced his actual attack. In the building occupied by Ross in Boca Raton two medical offices were also present. One is occupied by internists and the other office has doctors engaged in family practice. Ross has in the past consulted with both of these offices when medical problems occurred during or prior to performing surgery on his dental patients. These consultations and referrals involved anesthetics as well as actual medical symptoms. Respondent Ross is a well trained and gifted periodontal surgeon. He is held in very high esteem by his colleagues and peers. He serves as visiting professor and guest lecturer of periodontics at the University of Pennsylvania, Boston University, Loyola University (Chicago), Emory University, and Medical College of Georgia. He has lectured at various dental meetings in the U. S., Europe, Mexico, and South America. Here the ultimate factual issue is whether or not from the symptoms presented by Nathan Wolfson to Ross during his office visit on November 11, 1975 Ross should, in the exercise of the degree of care and knowledge expected of a dentist, have recognized that Wolfson was experiencing cardiac problems and required the immediate services of a medical practitioner. From the factual situation as noted in the above findings that question must clearly be answered, no. The evidence presented at this hearing was tainted by animosity and avarice as well as close friendship. The calibre of the latter was more impressive than the former.
The Issue The issue is whether Respondent failed to practice medicine at the level of care, skill, and treatment that is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances and, if not, the penalty.
Findings Of Fact Respondent is a licensed physician, holding license number ME 0026784. He is Board-certified in radiology. On January 30, 1997, T. D., a 30-year-old female who was eight months pregnant, presented to the emergency room of the Columbia Largo Medical Center complaining of pain in the left flank radiating to the left groin, together with nausea and vomiting. She also reported a prior history of kidney stones. A urologist diagnosed T. D. as suffering from kidney stones and severe hydronephrosis, which is the dilation of the kidney due to an obstruction in the flow of urine. The urologist was unable to pass a stent and catheter by the stones to drain the urine and relieve the pressure on the kidney, so he asked Respondent to perform a left percutaneous nephrostomy. A percutaneous nephrostomy is a procedure in which a physician places a tube through the skin and into the collecting system of the kidney to drain the kidney. The tube remains in place until the obstruction is removed. On February 1, Respondent performed a left percutaneous nephrostomy under local anaesthesia. For guidance in placing the tube, Respondent used ultrasound, rather than ultrasound and a flouroscopy. Respondent has performed 100-150 nephrostomies. As is the common practice, he normally does not rely exclusively ultrasound in guiding the placement of the tube in the kidney. In this case, the urologist asked that he not use a flouroscopy, in deference to the patient's pregnancy and the duration of x-ray exposure in a flouroscopy. Respondent was comfortable doing the procedure in this manner, although he decided that, if he encountered any problems in placement, he would resort to flouroscopy. Respondent proceeded to perform the percutaneous nephrostomy in the morning. As is typical, the radiology technician helped position T. D. on the table for the procedure. T. D.'s advanced pregnancy necessitated a slight adjustment to the normal posture of patients being prepared for this procedure, so T. D. lay slightly more up on her side than is usual. However, this did not change the point of entry chosen by Respondent. And, regardless of her precise position, the location of the spinal canal relative to the kidney relative to the point of entry into the skin remains constant: an imaginary line from the kidney to the spinal canal is perpendicular to an imaginary line from the point of entry to the kidney. The point of entry is on the lower back of the patient. T. D. is thin and her pregnancy did not manifest itself on her back, so the length of tube used by Respondent was relatively short. T. D.'s thin build makes it less likely that Respondent would have placed sufficient excess tube into the patient so as to permit the tube to run from the kidney to the spinal cord. Upon placement of the tube, at least 100 cc of fluid drained through the tube. This is well within the range of urine that would be expected under the circumstances. The color was well within the range of color for urine. The preponderance of the evidence indicates that the fluid was urine and that Respondent had placed the tube correctly in the kidney. At the end of the procedure, T. D. appeared a lot more comfortable. Late in the afternoon, someone called Respondent and told him that the drainage had slowed to a very small amount or nothing at all. This is not uncommon, as moving the patient or over-energetic nurses may accidentally dislodge the stent in the kidney. It is also possible that the tube has rested in a part of the kidney that does not facilitate maximum drainage. Using ultrasound, Respondent confirmed that the tube remained in place in the kidney, although he could not tell whether the stent had come to rest in a narrow place in the kidney or possibly even against a stone. Even with this uncertainty, Respondent still was able to determine that the stent was predominantly in the collecting system. Because T. D. was resting comfortably, she said that she felt fine, her fever was going down, and the hydronephrosis had decreased, Respondent decided to do nothing until after re-examining T. D. the next morning. However, at about 11:00 p.m. or midnight, Respondent, who was visiting a nearby patient, dropped in on T. D. The nurse said that she was fine and her kidney was draining a little better. T. D. also said that she was feeling fine. About three or four hours later, T. D. reported a feeling of some paralysis. Petitioner's expert testified that this was linked to the misplacement of the stent in the spinal canal, but he was unaware that T. D. had undergone a spinal block for the percutaneous nephrostomy and that a problem with the first anaesthetic procedure had necessitated a second. It is more likely that T. D.'s paralysis was in response to the two spinal blocks. At 9:00 a.m. the next day, Respondent returned and examined T. D. He found that she was still doing better, and her urologist was preparing to discharge her from the hospital. She looked better, and her urine flow had improved. He told her to call him if she had any problems, but he never heard from her again or even about her until he learned from the urologist that T. D. had been admitted to another hospital where a radiologist had inserted contrast material into the tube to locate the stent and found it in the spinal canal. The father of the baby picked up T. D. at the Columbia Largo Medical Center. He picked her up out of the wheelchair and placed her in the car. Her condition deteriorated once she got home. A hospital nurse directed the father to change the collection bag, if it filled prior to the visit of the home health care nurse. In the three or four days that T. D. remained at home, he changed the bag several times. He daily checked the site at which the tube entered T. D.'s skin and noticed that it had pulled out a little bit. However, he testified that he did not try to adjust the length of tube inside T. D., nor did he change the setting on the tube, which had "open" and "closed" settings for the pigtail at the end of the tube. The proper setting was closed, as the pigtail is not to be open once the stent has reached its destination in the kidney. On February 5, the father took T. D. to the emergency room of the Columbia St. Petersburg Medical Center, where she presented with complaints of severe back pain. An ultrasound confirmed the presence of kidney stones, whose removal had been deferred until the delivery of the baby. In an effort to locate the end of the tube, a radiologist inserted radiographic contrast dye, which showed that the end of the tube was in the intrathecal space of the spine. A urologist removed the tube. However, T. D. suffered a seizure. Another physician attempted an emergency C-section, but the baby did not live. There are two alternatives to explain how the stent at the end of the tube found its way into the spinal canal. First, Respondent placed it there during the procedure. Second, it migrated from the kidney, where Respondent placed it, to the spinal canal. If not unprecedented, both alternatives are extremely rare. The drainage during the procedure and initial improvement of the distended kidney are consistent with the proper initial placement of the stent. The difficulty of inadvertently turning a relatively short length of tube 90 degrees from the kidney to the spinal canal also militates against a finding that Respondent misinserted the tube. Problems with the first spinal tap may have contributed to some of the complaints, such as paralysis, that T. D. experienced after the procedure. Although unlikely, the migration alternative would be consistent with well-intended, but incorrect, attempts by the baby's father or a home health care nurse to ensure that the tube did not travel too far in or our of the point of entry. Migration would be facilitated if either the father or nurse misread the "open" and "closed" settings and turned to "open," in the hope of improving drainage, when such a setting opens the pigtail, which would increase the possibility that the stent could migrate into the spinal canal. In a case requiring proof that is clear and convincing, it is impossible to find that Petitioner has adequately proved that Respondent misinserted the tube during the procedure. Likewise, the evidence is not clear and convincing that Respondent should have recognized at anytime prior to T. D.'s discharge from the Columbia Largo Medical Center that something was wrong with the procedure that he had performed or that he needed to confirm by x-ray the location of the stent at the end of the tube.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 2nd day of August, 1999, in Tallahassee, Leon County, Florida. ROBERT E. MEALE 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 2nd day of August, 1999. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Fort Knox Building 3, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 William B. Taylor, IV Macfarlane, Ferguson & McMullen Post Office Box 1531 Tampa, Florida 33601-1531 Angela T. Hall, Agency Clerk Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Pete Peterson, General Counsel Department of Health Bin A02 2020 Capital Circle, Southeast Tallahassee, Florida 32399-1701 Tanya Williams, Executive Director Board of Medicine Department of Health 1940 North Monroe Street Tallahassee, Florida 32399-0750
The Issue The issue presented is whether Respondent is guilty of the allegations contained in the Administrative Complaint filed against him, and, if so, what disciplinary action should be taken against him, if any.
Findings Of Fact At all times material hereto, Respondent has been a physician licensed in the State of Florida and has been Board- certified in obstetrics and gynecology. On May 7, 1998, Patient A. J. underwent a laparoscopic procedure due to a complex left ovarian cyst at Columbia Surgical Park Center, an ambulatory care center located in Miami, Florida. The operation consisted of a laparoscopy with laparoscopic lysis of adhesions and a laparoscopic left ovarian cystectomy. Respondent performed the surgical procedure under general anesthesia. Gerald Kranis, M.D., was the anesthesiologist during the procedure. Respondent made a small vertical incision in the umbilicus and insufflated the abdomen with carbon dioxide gas. Respondent then entered the abdomen through a visiport with a 10-millimeter scope. He initially examined the upper abdomen. The patient’s liver and gall bladder appeared normal. Respondent next turned the laparoscope caudally. Inspection of the pelvic organs revealed numerous adhesions of the omentum and bowel to the anterior abdominal wall and to the uterus. Respondent took down the adhesions with sharp dissection with no bleeding. Respondent noted that there was adherence of the bowel to the anterior uterus. This was dissected away with sharp dissection. Inspection of the right adnexa showed a hemmoraghic cyst of the left ovary, and this was dissected by sharp dissection. In the process, the cyst ruptured extruding chocolate-appearing material. The cyst wall was grasped with an atraumatic grasper and teased out. Hemostasis was secure, and the cyst was retained to be sent to pathology. Inspection of the cul-de-sac revealed numerous adhesions of the bowel to the posterior uterus, and these were lysed with sharp dissection. At the end of the procedure, just before Respondent exited the abdomen, the patient’s blood pressure dropped. Inspection of the abdomen revealed no increased bleeding, but there was one area when viewed through the laparoscope that was suspicious of a hematoma. Respondent removed the laparoscope and placed a Foley catheter in the bladder. Respondent then performed a laparotomy, entering the abdomen through a Pfannenstiel incision. There were numerous adhesions of the bowel to the anterior abdominal wall, and Respondent lysed them with sharp dissection. Respondent then discovered a retroperitoneal hematoma. Respondent applied pressure on this area, and a vascular surgeon was summoned. Although the medical records do not specify that pressure was applied with a wet pad, the Department’s expert and Respondent’s expert interpret the description in the medical records to show that Respondent applied direct pressure with a wet pad. Upon his arrival, Manuel Torres-Salich, M.D., a vascular surgeon, assumed responsibility for managing the patient. He noted that the systolic pressure was 60 MMHG, and he extended the Pfannenstiel incision to a long midline vertical incision. Upon entering the abdominal cavity, he noticed a massive amount of blood throughout the abdominal cavity. However, he did not quantify the amount of blood he observed. Dr. Torres-Salich attempted the surgical repair of the patient’s vascular injuries. He discovered a large anterior laceration of the right proximal common iliac artery at the bifurcation of the aorta and a laceration of the anterior wall of the iliac vein. During the course of the surgical repairs, the patient experienced cardiac arrest, and CPR was administered while the vascular surgical repairs continued. As Dr. Torres-Salich continued to repair the vascular injuries, the patient experienced further cardiac complications. Cardiac massage and CPR were performed. The patient did not respond and expired. No evidence was offered as to the medical equipment available at Columbia Surgical Park Center. Specifically, no evidence was offered as to whether vascular clamps were available for use by Respondent, and, if available, whether these were the type of clamps appropriate for controlling a vascular injury of the iliac artery or iliac vein by a gynecologist. Further, no evidence was offered as to the types of medical personnel available at Columbia Surgical Park Center to assist Respondent other than anesthesia personnel. The record in this cause is clear, however, that a vascular surgeon was not in attendance at Columbia Surgical Park Center during patient A. J.’s procedure but was summoned on an emergency basis. The vascular surgeon arrived within about 20 to 25 minutes after the vascular emergency was discovered. The vascular lacerations that occurred to the iliac artery and iliac vein were lacerations to two of the largest blood vessels in the body. There is no evidence that any improper technique by Respondent during the laparoscopic procedure caused the lacerations of the iliac artery and iliac vein. The exact cause of these lacerations is not known. However, there are three possible causes: from insertion of the Voorhees needle, from insertion of the trocar, or from dissection of adhesions. A gynecologist who experiences a significant vascular injury, such as a laceration of an iliac artery, is trained to abandon the laparoscopic approach immediately, make an incision via laparotomy, and place direct pressure right on the area with a hand or pack. Respondent handled the laparoscopic complication appropriately by performing a laparotomy and applying direct pressure to the retroperitoneal hematoma. Respondent also handled the laparoscopic complication appropriately by calling for the emergency assistance of a vascular surgeon. General gynecologists are not trained to repair vascular injuries, and the immediate objective of a gynecologist once a vascular injury is identified is to do one of two things: apply direct pressure to the area of the bleed or try to clamp the vessel. Visualization of the specific vessel causing the bleed is required to properly use a clamp. Visualization of the specific blood vessels causing this patient’s retroperitoneal hematoma would require Respondent to perform a retroperitoneal dissection, which general gynecologists are not trained to perform. The standard of care in such a situation is for the gynecologist to summon a vascular surgeon. Further, if a gynecologist is not able to identify the exact point of injury, then direct pressure to the hematoma is sufficient and within the standard of care. There is no evidence that Respondent ever attended a gynecologic oncology fellowship where a general gynecologist would get additional training to be able to perform a retroperitoneal dissection. Respondent did not deviate from the standard of care by failing to perform a retroperitoneal dissection to visualize the specific blood vessels causing the hematoma. Respondent did not deviate from the prevailing standard of care by failing to apply pressure above the injury to stop the bleeding. Respondent’s application of pressure at the site of the hematoma was proper. Respondent did not fail to adequately prepare for and deal with a known complication of laparoscopy. He complied with the standard of care by stopping the laparoscopic approach, performing a laparotomy, applying pressure to the bleeding site, and immediately calling a vascular surgeon.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding Respondent not guilty of the allegations contained in the Administrative Complaint and dismissing the Administrative Complaint filed against him in this cause. DONE AND ENTERED this 28th day of March, 2001, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 28th day of March, 2001. COPIES FURNISHED: Kim M. Kluck, Esquire Agency for Health Care Administration 2727 Mahan Drive Building Three, Suite 3431 Post Office Box 14229 Tallahassee, Florida 32317-4229 Mark A. Dresnick, Esquire Sean M. Ellsworth, Esquire Dresnick, Ellsworth & Felder, P.A. SunTrust Plaza, Suite 701 201 Alhambra Circle Coral Gables, Florida 33134 Tanya Williams, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701 Theodore M. Henderson, Agency Clerk Department of Health 4052 Bald Cypress Way Bin A02 Tallahassee, Florida 32399-1701
The Issue The issue is whether Respondent failed to practice medicine with the required standard of care, in violation of Section 458.331(1)(t), Florida Statutes, and failed to keep required written medical records, in violation of Section 458.331(1)(m), Florida Statutes. If so, an additional issue is what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been a licensed physician in Florida, having been issued license number ME 0022608. Respondent is board-certified in ophthalmology. He was the principal investigator in the Excimer Laser Research Study. He is a fellow with the American College of Surgeons. He has published extensively in prominent medical and ophthalmologic journals. While still receiving medical training, Respondent gained experience in treating the ophthalmologic conditions of patients who suffer from Down Syndrome. While in practice, Respondent has continued to gain considerable experience in treating the ophthalmologic conditions of patients with Down Syndrome. Respondent has never previously been disciplined. U. V. was born on January 6, 1973. He suffered from Down Syndrome. As a young child, U. V. was diagnosed with inoperable congestive heart failure. Suffering from damage to two chambers of his heart and irreversible lung damage, U. V. had been in “terminal” condition since about the age of seven. Despite his serious medical problems, which are common to Down Syndrome patients, U. V. was a happy young man, who developed and matured as a teenager. He communicated his feelings and interacted with others, especially with his family. His mother adopted him when he was about five years old; previously, she had cared for him after his biological family had abandoned him. In March 1992, U. V. became quite ill. His physician discussed with U. V.’s mother the possibility of a Do Not Resuscitate order, but no order was ever given or entered into his medical records. U. V. rallied from his illness. His cardiologist found, after an office visit on October 13, 1992, that U. V. had made “tremendous progress” and was “doing quite well at this point in time.” This was the last time that U. V. visited his personal physician prior to the cataract surgery nearly a year later. In April of 1993, U. V. received home health care through the Hospices of Palm Beach. During this time, the hospice nurse who visited U. V. at home noted that he was sensitive about his Down Syndrome and social isolation. On July 14, 1993, the hospice nurse noted that she found U. V. to be “alert, ambulatory, cheerful.” U. V.’s mother told the nurse that U. V. wanted an eye surgeon to treat a cataract that had developed in his left eye, and the family would be willing to pay for the operation in installments, if health coverage would not pay for the surgery. Ten days later, during another home visit by the hospice nurse, U. V.’s mother again stated her concern about his cataract. The nurse told her to take U. V. to his primary care physician for a referral. U. V.’s family took U. V. to his family physician, who sent him to an optometrist. The optometrist determined that U. V. had a cataract in his left eye and was starting to develop one in his right eye too. The optometrist told them that surgery could correct the condition and referred U. V. to Respondent. About a month later, in late August, U. V.’s mother informed the hospice nurse that they had an appointment with an eye surgeon and hoped that he would remove the cataract from U. V.’s left eye. At this time, U. V. was still leading an active life, largely due to the support and assistance of his loving family. He was happy and enjoyed dancing at weddings and parties and watching television. The family thought that surgery would help him see better with his left eye. Respondent first examined U. V. on August 31, 1993. He found a hypermature cataract in U. V.’s left eye. U. V.’s eye was totally opacified by the cataract to such an extent that he could see only hand motion. Respondent was immediately concerned with the possibility of phacolytic glaucoma. This is a condition in which the cataract liquifies and may leak through the lens capsule, resulting in an immunological reaction. Phacolytic glaucoma is extremely painful. It is impossible to predict the precise onset of phacolytic glaucoma, but Respondent reasonably determined that the condition could develop in as little time as hours or days, although it was possibly months away. Respondent was also concerned with U. V.’s right eye. Respondent found a cataract in the right eye in the lens where all the light rays pass into the eye. This type of cataract advances rapidly, so much so that it might overtake in seriousness the older cataract in U. V.’s left eye. Respondent performed a comprehensive examination of both eyes. He discussed cataract surgery with U. V.’s mother. Respondent agreed to perform the surgery for the Medicaid payment. He carefully explained the condition of U. V.’s left eye and the risks and benefits of surgery and general anesthesia. To assist in communicating with U. V.’s Spanish-speaking mother, Respondent had someone in the office translate for the mother. After hearing the explanation, U. V.’s mother agreed to the surgery, and Respondent set up the surgery for September 7, 1993. After returning home, U. V. began complaining of problems with his right eye. His sight was deteriorating at this time, heightening his feeling of isolation from the world around him. In the meantime, Respondent had the laboratory work done in preparation for the surgery. His office contacted U. V.’s physicians to get medical information in preparation for the cataract surgery. But they were unable to get such information from the physicians’ offices. On September 7, U. V. and his family returned to Ft. Myers for the surgery. The board-certified anesthesiologist examined U. V. and found that he had wheezing respiration, so the anesthesiologist told Respondent that the surgery had to be postponed. Respondent rescheduled the surgery for September 15, 1993. Respondent and the anesthesiologist then discussed the possibility of using a local anesthetic, which would present fewer risks to U. V. than would be posed by a general anesthetic. But, as is typical with Down patients, U. V. had been fidgety during the August 31 office visit and was a poor candidate for local anesthesia during the extremely delicate cataract surgery that he was about to undergo. Respondent and the anesthesiologist agreed that U. V. would receive general anesthesia for the surgery. After the first surgery was canceled, the anesthesiologist undertook the task of obtaining the medical clearances for general anesthesia. He spoke with U. V.’s primary physician, who practices in the small town where U. V. lived at the south end of Lake Okeechobee between Clewiston and Belle Glade. U. V.’s primary physician appeared as a witness at the hearing. He seemed to suffer from communication problems not entirely attributable to obvious difficulties with the English language. Not surprisingly, the anesthesiologist obtained little useful information from the physician. The anesthesiologist’s nurse called the cardiologist’s office several times on September 15 prior to the surgery. Unable to reach the cardiologist or any of his partners, the anesthesiologist spoke with one of the cardiologist’s office nurses and had her read him U. V.’s chart. Especially interested in U. V.’s cardiac malformations, the anesthesiologist satisfied himself that U. V. could withstand the rigors of general anesthesia and developed a plan, after discussing the case with his partners, to use special drugs and techniques so as to affect V.’s heart and lungs as little as possible. The anesthesiologist also studied either a chest xray taken on September 6, 1993, or a report of the chest xray taken on that date. He examined the xray or report to determine if U. was suffering from any reversible heart problems that might resolve themselves if surgery were postponed. The anesthesiologist found no cardiac problems of this type. Prior to the administration of the general anesthesia, the anesthesiologist spent several hours with U. V. and his family discussing the risks and benefits of general anesthesia. U. V.’s mother accepted the risks and agreed to the use of the general anesthesia. U. V.’s cardiologist testified that, if asked about the surgery and general anesthesia, he would have cautioned Respondent and the anesthesiologist of the risks of surgery, but he would not have offered an opinion on the advisability of using general anesthesia on U. V. The cardiologist would have left the decision on this matter to the anesthesiologist. On September 15, 1993, Respondent removed the cardiac from U. V.’s left eye. The surgery was flawless. During the surgery, U. V. was stable and tolerated the anesthesia. Following the surgery, U. V. awoke in the recovery room, where he was alert and following commands. Once U. V. began to breathe better on his own, the ventilator machine was turned off. U. V. suddenly developed cardiac arrhythmia and died within an hour. Respondent did not deviate from the applicable standard of care in his diagnosis and treatment of U. V. Respondent’s medical records amply memorialize his diagnosis and fully justify the surgery undertaken on September 15, 1993.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order dismissing the administrative complaint against Respondent. ENTERED in Tallahassee, Florida, on June 4, 1997. ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings on June 4, 1997. COPIES FURNISHED: Britt Thomas, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 John F. Lauro, Esquire John F. Lauro, P.A. Suite 3950 101 East Kennedy Boulevard Tampa, Florida 33602 Dr. Marm Harris Executive Director Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0972 Jerome Hoffman, Esquire Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403
Findings Of Fact Galencare, Inc., d/b/a Northside Hospital ("Northside") and NME Hospitals, Inc., d/b/a Palms of Pasadena Hospital ("Palms") were litigants in administrative proceedings concerning the Agency For Health Care Administration's ("AHCA's") preliminary action on certificate of need applications. Northside moved to dismiss Palms' application based on defects in the corporate resolution. The resolution is as follows: RESOLVED, that the Corporation be and hereby is authorized to file a Letter of Intent and Certificate of Need Application for an adult open heart surgery program and the designation of three medical/surgical beds as a Coronary Intensive Care Unit as more specifically described by the proposed Letter of Intent attached hereto. RESOLVED, that the Corporation is hereby authorized to incur the expenditures necessary to accomplish the aforesaid proposed project. RESOLVED, that if the aforedescribed Certificate of Need is issued to the Corporation by the Agency for Health Care Administration, the Corporation shall accomplish the proposed project within the time allowed by law, and at or below the costs contained in the aforesaid Certificate of Need Application. RESOLVED, that the Corporation certifies that it shall appropriately license and immediately there- after operate the open heart surgery program. In its Motion, Northside claimed that the third and fourth clauses in the Resolution are defective, the third clause because it does not "certify" that the time and cost conditions will be met and the fourth for omitting "adult" to describe the proposed open heart surgery program. Northside relies on the language of the statute requiring that a resolution shall contain statements . . .authorizing the filing of the application described in the letter of intent; authorizing the applicant to incur the expenditures necessary to accomplish the proposed project; certifying that if issued a certificate, the applicant shall accomplish the proposed project within the time allowed by law and at or below the costs contained in the application; and certifying that the applicant shall license and operate the facility. Subsection 408.039(2)(c), Florida Statutes. Northside also relies on Rule 59C-1.008(1)(d), which is as follows: The resolution shall contain, verbatim, the requirements specified in paragraph 408.039 (2)(c), F.S., . . . Palms' filed the Motion For Sanctions against Northside on November 15, 1993, pursuant to Subsection 120.57(1)(b)5 for filing a frivolous motion for an improper purpose, needlessly increasing the cost of the litigation, with no legal basis. Northside's claims that the Resolution was defective were rejected in the Recommended Order of Dismissal of January 11, 1994, amended and corrected on January 26, 1994, and not discussed in AHCA's Final Order of March 15, 1994.
