The Issue Whether Respondent violated Subsections 458.331(1)(t) and 458.331(1)(m), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact At all times material to this proceeding, Dr. Abdel- Aziz was a licensed physician within the State of Florida. He has been licensed to practice medicine in Florida since 1985. Dr. Abdel-Aziz is board-certified in obstetrics and gynecology. Since 1993, Dr. Abdel-Aziz has been patient D.D.'s obstetrician and gynecologist. In April 2000, when D.D. presented to Brandon Regional Hospital in labor, D.D. was 35 years old and had had three prior pregnancies. In 1993, D.D. has a missed abortion which was treated with suction D & C. D.D.'s second pregnancy in 1995 was at 41 weeks with spontaneous labor, and the baby was delivered with forceps. In 1997, D.D.'s third pregnancy went to term and was a spontaneous labor with spontaneous vaginal delivery. On admission to Brandon Regional Hospital on April 18, 2000, there were no known problems with D.D.'s fetus. D.D. was admitted to labor room 3 and placed on a fetal heart monitor at 15:04 hours. The fetal heart tones at that time were reported as 130 base line with good variability. D.D.'s contractions were reported as two every ten minutes. Dr. Abdel-Aziz ordered Pitocin to be administered to D.D. on April 18, 2000. Pitocin is the synthetic form of oxytocin, a hormone that is produced naturally in the body and is responsible for causing the uterus to contract during labor. At the time of D.D.'s admission, Brandon Regional Hospital had an established protocol for administering Pitocin during labor. Forty-five minutes later, at 15:45, the fetal heart tones were reported to show good variability and normal rate. There were accelerations and no decelerations were noted by D.D.'s nurse. D.D.'s contractions were reported to be irregular every two to six minutes and 30 to 60 seconds in duration. At 19:30 hours on April 18, 2000, D.D. was examined, her cervix was at 3-4 cm dilated, 80 percent effaced, and vertex was at -2/-3 station. Artificial rupture of the membranes was performed at 19:30 hours, and the amniotic fluid was noted in D.D.'s medical records to be clear. At 20:45 hours the Pitocin drip was switched off to allow for the administration of the epidural anesthetic. D.D. received the epidural anesthesia, and the Pitocin drip was restarted at 21:10 hours. D.D. was examined at 21:12 hours, and her cervix was found to be 5 cm dilated and 80 percent effaced with vertex at -2 station. At 22:20 hours, D.D. was again examined. Her cervix was 7 to 8 cm dilated, 100 percent effaced with vertex at 0 station. At 22:24 hours, Dr. Abdel-Aziz was notified about D.D.'s condition, and he gave instructions to the nurse on how to contact him. The hospital records for D.D. show that at 22:50 hours, the Pitocin drip was increased from 6 to 7 mu/min per protocol. The hospital records for D.D. show, according to the monitor clock, that at 22:50 hours there were adequate contractions and good fetal heart tones at baseline with variability. The fetal heart rate baseline was reported at around 150 beats per minute. D.D. was receiving Pitocin at 7 mu/min. Dr. Abdel-Aziz examined D.D. at 22:55 hours. There was no fetal distress evident. D.D.'s cervix was fully dilated, 100 percent effaced, vertex at +1 station. At that time, D.D. began pushing. Pitocin was being administered as ordered at 7 mu/min. At 22:55 hours Dr. Abdel-Aziz notified the nurse on how to contact him with any problems and informed the nurse that he would remain in the hospital. A non-reassuring fetal heart rate pattern is a pattern which gives one concern about the well-being of the baby. At 23:15 hours, Baby D. had a non-reassuring heart rate. The hospital records for D.D. do not show that the nurse notified Dr. Abdel-Aziz of the problems evident at 23:15 hours. At around midnight on April 18, 2000, D.D. was still pushing and was in the second stage of labor. The fetal heart rates were non-reassuring at this time. A review of the fetal heart monitor strip showed that Baby D. was experiencing late decelerations. A late deceleration is a slowing of the fetal heart rate which comes at the end of a contraction and is repetitive. At midnight D.D.'s contractions and progress were reported by the nurses as good. Although Baby D. was showing non-reassuring heart rate patterns, the fetal heart tones were erroneously reported as assuring. Dr. Abdel-Aziz was not notified of the non-reassuring heart rate which was present at midnight. D.D. was still receiving Pitocin at 7 mu/min at midnight. Shortly thereafter, at 00:15 hours on April 19, 2000, D.D.'s nurse increased D.D.'s Pitocin drip from 7 mu/min to 9 mu/min. Dr. Abdel-Aziz did not order the increased dosage of Pitocin. At 00:30 hours, the Pitocin was increased to 11 mu/min and then at 00:45 hours, increased once more to 13 mu/min. Dr. Abdel-Aziz did not order the increase of Pitocin either at 00:30 hours or 00:45 hours. The increased dosage of Pitocin was done by the nurse attending D.D., without the consulting Dr. Abdel-Aziz. The increases of Pitocin at 00:15, 00:30, and 00:45 hours were unnecessary as D.D. was making adequate progress on the 7 mu/min dosage. At 00:30 hours, Baby D.'s heart rate showed tachycardia, which means that the fetal heart rate exceeded 160 beats per minute. Tachycardia is a non-reassuring heart rate pattern. Tachycardia was evidenced again approximately at 00:35 hours and persisted for another 20 minutes intermittently with late decelerations. At 01:00 hours there was a pattern of late decelerations. At 01:15 and 01:24 hours there were episodes of tachycardia, followed by late decelerations. At 01:31 hours the fetal monitor shorted out for approximately eight minutes and did not pick up the fetal heart rate. Beginning around 01:39 hours, a new fetal heart pattern appeared without either tachycardia or late decelerations. At approximately 01:30 hours, D.D. was exhausted and wanted Dr. Abdel-Aziz to delivery the baby by using forceps. The nurse went to get Dr. Abdel-Aziz to examine D.D. Dr. Abdel- Aziz presented at the D.D.'s bedside at 01:30 hours and examined the patient. The baby's head was not low enough for a forceps delivery. D.D. strongly wanted to have a vaginal delivery and agreed to push for another 30 minutes. Dr. Abdel-Aziz did not review the fetal heart monitor recordings. At 01:55 hours, Dr. Abdel-Aziz again presented at D.D.'s bedside and examined D.D. At that point, Dr. Abdel-Aziz called for delivery by caesarean section. Dr. Abdel-Aziz did not review the fetal heart monitor recordings. D.D. was taken to the operating room. While D.D. was on the operating table, the fetal heart rate dropped from 120 to 80, and Dr. Abdel-Aziz was so advised. Dr. Abdel-Aziz performed a caesarean delivery. When Dr. Abdel-Aziz opened D.D.'s abdomen, he found meconium-stained fluid mixed with blood and suspected there was a uterine rupture. He delivered Baby D. and found the rupture, which he repaired. D.D. experienced a "silent" rupture. No symptoms of a rupture were present during D.D.'s labor. No complaints of abdominal pain were recorded by D.D.'s nurses and none were reported to Dr. Abdel-Aziz. No blood was seen oozing from the vagina at anytime during D.D.'s labor such that a uterine rupture could have been suspected any earlier than when it was noted by Dr. Abdel-Aziz when he performed a cesarean on D.D. No meconium was present at anytime during the labor. On delivery Baby D. had no pulse. After oropharyngeal and nasopharyngeal suctioning were performed, Baby D. was given to a neonatal service representative and was resuscitated. Baby D. was placed on life support. The life support was later discontinued, and Baby D. died. Between the hours of 23:00 on April 18, 2000, and 2:00 on April 19, 2000, no fetal scalp electrode was applied. It was not necessary to apply a fetal scalp electrode because the fetal heart monitor was recording non-reassuring fetal heart rate patterns, which were readily discernable from looking at the monitor's recordings. The standard of care requires that when a physician examines an obstetric patient in labor that the physician review at least the last 30 minutes of the fetal monitoring records. The standard of care of for a reasonably prudent physician who would have examined D.D. at 01:30 hours would have been to attempt intrauterine resuscitation by stopping the contractions, giving oxygen, giving more IV fluids to dilute the pitocin, and changing the position of the mother. If those efforts were unsuccessful, an emergency cesarean section would have been the appropriate course of action.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mohamed I. Abdel-Aziz did not violate Subsection 458.331(1)(m), Florida Statutes, finding that he did violate Subsection 458.331(1)(t), Florida Statutes, placing him on probation for six months, imposing an administrative fine of $7,500 to be paid within 90 days of the issuance of the Final Order, and requiring the completion of six hours of continuing medical education courses in obstetrics and four hours in risk management within one year. DONE AND ENTERED this 2nd day of June, 2003, in Tallahassee, Leon County, Florida. SUSAN B. KIRKLAND 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 June, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Jon M. Pellett, Esquire Barr, Murman, Tonelli, Slother & Sleet, P.A. 201 East Kennedy Boulevard Suite 1700 Tampa, Florida 33602 William W. Large, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
The Issue Whether proposed rule amendments to Rule 59C- 1.033(7)(c) and (7)(d), Florida Administrative Code, published in the Notice of Change on June 15, 2001, constitute an invalid exercise of delegated legislative authority. Whether the proposed rule is invalid due to the absence of a provision specifying when the amendments will apply to the review of certificate of need applications to establish open heart surgery programs.
Findings Of Fact The Agency is responsible for administering the Health Facility and Services Development Act, Sections 408.031-408.045, Florida Statutes. The goals of the Act are containment of health care costs, improvement of access to health care, and improvement in the quality of health care delivered in Florida. AHCA initiated the rulemaking process by proposing amendments to existing Rule 59C-1.033, Florida Administrative Code, the rule for determining the need for adult open heart surgery (OHS)1 services, which currently provides, in part, that: Adult Open Heart Surgery Program Need Determination. a new adult open heart surgery program shall not normally be approved in the district if any of the following conditions exist: There is an approved adult open heart surgery program in the district. One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 3 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 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or One or more of the adult open heart surgery programs in the district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than an average of 29 adult open heart surgery operations per month. Provided that the provisions of paragraphs (7)(a) and (7)(c) do not apply, the agency shall determine the net need for one additional adult open heart surgery program in the district based on the following formula: NN =((Uc x Px)/350)) -- OP>=0.5 Where: NN = The need for one additional adult open heart surgery program in the district projected for the applicable planning horizon. The additional adult open heart surgery program may be approved when NN is 0.5 or greater. Uc = Actual use rate, which is the number of adult open heart surgery operations performed in the district during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool, divided by the population age 15 years and over. For applications submitted between January 1 and June 30, the population estimate used in calculating Uc shall be for January of the preceding year; for applications submitted between July 1 and December 31, the population estimate used in calculating Uc shall be for July of the preceding year. The population estimates shall be the most recent population estimates of the Executive Office of the Governor that are available to the department 3 weeks prior to publication of the fixed need pool. Px = Projected population age 15 and over in the district for the applicable planning horizon. The population projections shall be the most recent population projections of the Executive Office of the Governor that are available to the department 3 weeks prior to publication of the fixed need pool. OP = the number of operational adult open heart surgery programs in the district. Regardless of whether need for a new adult open heart surgery program is shown in paragraph (b) above, a new adult open heart surgery program will not normally be approved for a district if the approval would reduce the 12 month total at an existing adult open heart surgery program in the district below 350 open heart surgery operations. In determining whether this condition applies, the agency will calculate (Uc x Px)/(OP+1). If the result is less than 350 no additional open heart surgery program shall normally be approved. Based on the issues raised by the Petitioner, Bethesda, and the factual evidence presented on these issues, AHCA must demonstrate that its proposed amendments to the existing OHS rule are valid exercises of delegated legislative authority or, more specifically, that it (a) followed the statutory requirements for rule-making, particularly for changing a proposed rule; (b) considered the statutory issues necessary for the development of uniform need methodologies; (c) acted reasonably to eliminate potential problems in earlier drafts of the proposed rule; (d) used appropriate proxy data to project the demand for the service proposed; (e) appropriately included county considerations for a tertiary service with a two-hour travel time standard; and (f) was not required to include a provision advising when CON applications would be subject to the new provisions. Rule challenges and rule development process The existing rule was challenged by IRMH on June 27, 2000, in DOAH Case No. 00-2692RX. Martin Memorial intervened in that case, also to challenge the rule. Like IRMH, Martin Memorial was an applicant for a certificate of need (CON), the state license required to establish certain health care services, including OHS programs, in Florida. Both are located in AHCA health planning District 9, as is the Petitioner in this case, Bethesda. AHCA entered into a settlement agreement with IRMH and Martin Memorial on September 11, 2000, which was presented when the final hearing commenced on September 12, 2000. Prior to the rule challenge settlement agreement, staff at AHCA had been discussing, over a period of time, possible amendments to the OHS rule to expand access and enhance competition. Issues raised by AHCA staff included the continued appropriateness of OHS as a designated tertiary service and the anti-competitive effect of the 350 minimum volume of OHS cases required of existing providers prior to approval of a new provider in the same district. The staff was considering whether the rule was too restrictive and outdated given the advancements in technology and the quality of OHS programs. The relationship of volume to outcomes was considered as various studies and CON applications were received and reviewed, as was the increasing use of angioplasty also known as percutaneous coronary angioplasty, referred to as PTCA or simply, angioplasty, as the preferred treatment for patients having heart attacks. Angioplasty can only be performed in hospitals with backup open heart services. During an angioplasty procedure, a catheter or tube is inserted to open a clogged artery using a balloon-like device, sometimes with a stent left in the artery to keep it open. Discussions of these issues took place at AHCA over a period of years, during the administrations of the two previous Agency heads, Douglas Cook and Reuben King-Shaw. In August 2000, AHCA published notice of a rule development workshop to consider possible changes to the OHS rule. Because it could not get the parties to settle DOAH Case No. 00-2692RX at the time, rather than proceed with the workshop while defending the existing rule, AHCA cancelled the workshop. As a result of the September 11, 2000, settlement agreement, on October 6, 2000, AHCA published a proposed rule amendment and notice of a workshop, scheduled for October 24, 2000. That version of a proposed rule would have changed Subsection (7)(a) of the OHS Rule to allow approval of "additional programs" rather than being limited to approval of one new program at a time in a district. The October proposal would have also eliminated OHS from the list of tertiary health services in Rule 59C-1.002(41). Tertiary health services are defined, in general, in Subsection 408.032(17), Florida Statutes, as follows: "Tertiary health service" means a health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost-effectiveness of such service. Examples of such services include, but are not limited to, organ transplantation, specialty burn units, neonatal intensive care units, comprehensive rehabilitation, and medical or surgical services which are experimental or developmental in nature to the extent that the provision of such services is not yet contemplated within the commonly accepted course of diagnosis or treatment for the condition addressed by a given service. The agency shall establish by rule a list of all tertiary health services. With this statutory authority, AHCA adopted Rule 59C- 1.002(41), Florida Administrative Code, to provide a more specific and complete list of tertiary services: The types of tertiary services to be regulated under the Certificate of Need Program in addition to those listed in Florida Statutes include: Heart transplantation; Kidney transplantation; Liver transplantation; Bone marrow transplantation; Lung transplantation; Pancreas and islet cells transplantation; Heart/lung transplantation; Adult open heart surgery; Neonatal and pediatric cardiac and vascular surgery; and Pediatric oncology and hematology. As an additional assurance that tertiary services are subject to CON regulation, the tertiary category is specifically listed in the projects subject to review in Subsection 408.036, Florida Statutes. The October 2000 version included a proposal to increase the divisor from 350 to 500 in the formula in Subsection (7)(b), to represent the average size of existing OHS programs, but to decrease from 350 to 250, the minimum number required of an existing provider prior to approval of a new program in Subsection (7)(a)2. The definition of OHS would have been amended to add an additional diagnostic group, DRG 109, to delete DRG 110 and to eliminate the requirement for the use of the heart-lung by-pass machine during the surgery. Most controversial in the October version was a separate county- specific need methodology for counties which have hospitals but not OHS programs, in which residents are projected to have 1,200 annual discharges with a principal diagnosis of ischemic heart disease. On October 24, 2000, AHCA held a workshop on the proposed amendments. At the workshop, AHCA Consultant, John Davis, outlined the proposed changes. As a practical matter, eight Florida counties are not eligible to provide OHS because they have no hospitals. When Mr. Davis applied the county-specific need methodology, as if it were in effect for the planning horizon of January 2003, six Florida counties demonstrated a need for OHS: Hernando, Martin, Highlands, Okaloosa, Indian River, and St. Johns. Two of these, Martin and Indian River are in AHCA District 9. AHCA has already approved an OHS program for Martin County, at Martin Memorial. Mr. Davis also presented a simplified methodology for reaching the same result. In support of the proposed rule, AHCA received data, although not adjusted by the severity of cases, showing better outcomes in hospitals performing from 250 to 350 OHS, as compared to larger providers. Although the majority of heart attack patients are treated with medications, called thrombolytics, for some it is inappropriate and less effective than prompt, meaning within the so-called "golden hour," interventional therapies. In these instances, angioplasty is considered the most effective treatment in reducing the loss of heart muscle and lowering mortality. Opposing the proposed rule at the October workshop, Christopher Nuland, on behalf of the FSTCS, testified that OHS is still a highly complex procedure, that it requires scarce resources, equipment and personnel, and should, therefore, be available in only a limited number of facilities. In general, however, the opponents complained more about process rather than the substance of the proposal. Having petitioned on October 13, 2000, for a draw-out proceeding instead of the workshop, those Petitioners noted that AHCA had obligated itself to predetermined rule amendments based on the settlement agreement, regardless of information developed in the workshop. The draw- out Petitioners were the Florida Hospital Association, Association of Community Hospitals and Health Systems of Florida, Inc., Delray, Lakeland Regional Medical Center, Punta Gorda HMA, Charlotte Regional Medical Center, JFK, HCA Health Services of Florida, Inc., d/b/a Regional Medical Center Bayonet Point; Tampa General and the FSTCS. While agreeing that OHS is complex and costly, supporters of the proposed rule, particularly the declassification of OHS as a tertiary service, noted that many cardiologists are now trained to do invasive procedures. In support of fewer restrictions on the expansion of OHS programs in Florida, other witnesses at the October workshop discussed delays and difficulties in arranging transfers to OHS providers, possible complications from deregulated diagnostic cardiac catheterizations at non-OHS provider hospitals, and hardships of travel on patients and their families, especially older ones. On December 22, 2000, AHCA published another proposal, which retained most of the October provisions, continuing the elimination of OHS from the list of tertiary services, the addition of DRG 109, the deletion of DRG 110, the elimination of the requirement for the use of a heart-lung by-pass machine, and the authorization for approval of more than one additional OHS program at a time in the same district. The minimum number of OHS performed by existing providers prior to approval of a new one continued from the October 2000 version, to be decreased from 350 to 250, and the divisor in the numerical need formula continued to be increased from 350 to 500. As in the October version, the requirement that existing providers be able to maintain an annual volume of 350 OHS cases after approval of a new program was stricken. The separate need methodology for counties without an OHS program was simplified, as proposed by Mr. Davis, and was as follows: Regardless of whether need for additional a new adult open heart surgery programs is shown in paragraph (b) above, need for one a new adult open heart surgery program is demonstrated for a county that meets the following criteria: None of the hospitals in the county has an existing or approved open heart surgery program; Residents of the county are projected to generate at least 1200 annual hospital discharges with a principal diagnosis of ischemic heart disease, as defined by ICD-9- CM codes 410.0 through 414.9. The projected number of county residents who will be discharged with a principal diagnosis of ischemic heart disease will be determined as follows: PIHD = (CIHD/CoCPOP X CoPPOP) Where: PIHD = the projected 12-month total of discharges with a principal diagnosis of ischemic heart disease for residents of the county age 15 and over; CIHD = the most recent 12-month total of discharges with a principal diagnosis of ischemic heart disease for residents of the county age 15 and over, as available in the agency's hospital discharge data base; CoCPOP = the current estimated population age 15 and over for the county, included as a component of CPOP in subparagraph 7(b)2; CoPPOP = the planning horizon estimated population age 15 and over for the county, included as a component of PPOP in subparagraph 7(b)2; If the result is 1200 or more, need for one adult open heart surgery program is demonstrated for the county will not normally be approved for a district if the approval would reduce the 12 month total at an existing adult open heart surgery program in the district below 350 open heart surgery operations. In determining whether this condition applies, the agency will calculate (Uc X Px)/(OP + 1). If the result is less than 350 no additional open heart surgery program shall normally be approved. County-specific need identified under paragraph (c) is a need occurring because of the special circumstances in that county, and exists independent of, and in addition to, any district need identified under the provisions of paragraph (b). A program approved pursuant to need identified in paragraph (c) will be included in the subsequent identification of approved and operational programs in the district, as specified in paragraph (a). On January 17, 2001, a public hearing was held to consider the December amendments. Opponents complained that the proposals resulted from a private settlement agreement rather than a public rule development workshop as required by law. They noted that declassification of OHS as a tertiary service is contrary to the recommendations of AHCA's CON advisory study group and the report of the Florida Commission on Excellence in Health Care, co-chaired by AHCA Secretary Reuben King-Shaw, created by the Florida Legislature as a part of the Patient Protection Act of 2000. The risk of inadvertently allowing some OHS procedures to become outpatient services was also raised, because of the statute that specifically states that tertiary services are CON-regulated. The reduction from 350 to 250 in the annual volume required at existing programs prior to approval of new ones was criticized for potentially increasing costs due to shortages in qualified staff, including surgical nurses, perfusionists, recovery and intensive care unit nurses, who are needed to staff the programs. The potential for approval of more than one program at a time, under normal circumstances, was viewed as an effort to respond to the needs of two geographically large districts out of the total of eleven health planning districts in Florida. That, in itself, one witness argued demonstrated that more than one approval at a time should be, as it currently is, a not- normal circumstance. The combination of the district-wide and county- specific need methodologies was criticized as double counting. The district formula which relied on the projected number of OHS, overlapped with the county formula, which used projected ischemic heart disease discharges, to the extent that the same patient hospitalization could result in first, the diagnosis, and then the OHS procedure. Approximately, eighteen percent of diagnosed ischemic heart disease patients in Florida go on to have OHS. The county-specific methodology was also characterized as inappropriate health planning based on geo- political boundaries rather than any realistic access barriers. Although 500, the average size of existing programs was the proposed divisor in the formula, and 250 was the threshold number existing providers, the proposal included the deletion of any provision assuring that existing programs maintain some minimum annual volume, which is 350 in subsection 7(e) of the current rule. AHCA representatives testified that the proposal to delete a minimum adverse impact was inadvertent. The combined effect of a district-wide need methodology, an independent but overlapping county need methodology, and the absence of an adverse impact provision, created concern whether approvals based on county need determinations could reduce volumes at providers in adjacent counties to unsafe levels. Some health planners predicted that, as a consequence of adopting the December draft, like the October version, a number of new OHS programs could be coming into service at one time, seriously draining already scarce resources. One witness, citing an article in the Journal of the American Medical Association, testified that higher volume OHS providers, those over 500 cases, do have better outcomes, and that the relationship persists for angioplasties, including those performed on patients having heart attacks. Florida has 63 or 64 OHS programs. Of those, 25 to 30 percent have annual OHS volumes below 350 surgeries a year. The demand for OHS is increasing slowly and leveling off. AHCA was warned, at the January public hearing by, among others, Eric Peterson, Professor of Cardiology, Duke University Medical Center (by videotaped presentation); and Brian Hummel, M.D., a Cardiothoracic Surgeon in Fort Myers, President of the Florida Society of Thoracic and Cardiovascular Surgeons, that simultaneously easing too many provisions of the OHS rule was a risk to the quality of the programs and the safety of patients. Among other specific comments made at the January public hearing related to the December proposal were the following: This change would authorize a county- specific methodology to support approving a program on the theory that that county needs better access to open heart surgery program. Yet there is no inquiry under the proposed provision into how accessible adjacent programs are or, indeed, how low the volumes of adjacent programs are. Most blatantly, the county provision requires double counting and double need projections. (AHCA Ex. 7, p. 14, by Elizabeth McArthur). The proposed rule creates an exemption for counties that are currently without open heart surgery programs. One can only surmise that the purpose of this exemption is to improve access, and certainly improving access is an appropriate goal and it is possible that there are few situations around the state where access to open heart surgery is a concern, but the proposed rule is completely inadequate and a thoroughly inappropriate way to identify which situations those are . . . (AHCA Ex. 7, p. 26, by Carol Gormley). With the county exemption provision, the Agency has stumbled on an entirely new method for estimating need. In fact, the only good thing about this provision is that it demonstrates that the Agency actually can look at some alternative ways to estimate need, and the use of data about incidence of ischemic heart disease might be one of those. Certainly it should be explored if there is ever a valid planning process that addresses open heart surgery. However, the proposed rules cobble together the county- based epidemiology with the district-wide demand based formula, and I believe that this method is not applicable for evaluating access to care. It is not applicable because the provision only considers the population's rate of ischemic heart disease and does not even attempt to assess the extent to which county residents with ischemic disease are, in fact, already receiving open heart surgery. Therefore, a determination that county residents generate at least 1,200 ischemic heart disease discharges annually does nothing to indicate whether or not they experience any barriers to obtaining that needed service. * * * Another problem with county exemption permission [sic: provision] is that the addition of this assessment, quote "regardless of the results of the district need formula," end quote, constitute double counting of a need in districts where counties without programs are located. (AHCA Ex. 7, p. 27-30, by Carol Gormley). * * * As further evidence of the benefits of limiting open heart surgery to a few high volume programs, the Society would like to place into record the following articles. The first one you've heard on several occasions is the Dudley article, "Selective referral to high volume hospitals." The second, from Farley and Osminkowski, is, "Volume-outcome relationships and in- hospital mortality: Effective changes in volume over time," from Medicare in January of 1992. There's another article from Grumbach, et al., "Regionalization of cardiac surgery in the United States and Canada," again from JAMA. Another article from Hannon, et al., "Coronary artery bypass surgery: The relationship between in-hospital mortality rate and surgical volume after controlling for clinical risk factors," Medical Care. Hughes, et al., "The effects of surgeon volume and hospital volume on quality care in hospitals," again from Medical Care; finally, Riley and Nubriz, "Outcomes of surgeries among Medicare aged: Surgical volume and mortality." Each of these scholarly articles comes to the same inevitable conclusion: outcomes improve as the volume of cardiac surgeries in any given program and hospital increases, therefore increasing the number of hospitals in which these services are provided inevitably will lead to an increase in morbidity. (AHCA Ex. 7, p. 83-84, by Christopher Nuland). * * * On or before the January public hearing, AHCA also received the following written comments: Martin Memorial supports the exception provision for Counties that do not have an open heart surgery program and have a substantial number of residents experiencing cardiovascular disease. This provision ensures an even dispersion of programs, and that adequately sized communities are not denied open heart surgery. (Martin Memorial Ex. 6, Letter of 10/24/2000, from Richard M. Harman, Chief Executive Officer, Martin Memorial, to Elizabeth Dudek) * * * Adding new open heart surgery programs to counties that currently lack programs will increase geographic access to coronary angioplasty services as well as open heart surgery. Primary angioplasty is now the treatment of choice for a significant percentage of patients presenting in the emergency department with acute myocardial infarction (patients who would otherwise be treated with thrombolytic drugs to dissolve blood clots in occluded coronary arteries). Thus, the provision of the proposed regulations that addresses the need for open heart surgery at a county level will also increase access to life-saving invasive cardiology services. The effect of the proposed rule changes is to slightly broaden the circumstances in which the Agency would see presumed need for new programs. Initially, the increase in the number of programs presumed to be needed would be only five. These potential new approvals would be in counties which currently have no programs. This is consistent with the reasoning that supports removing open heart surgery from the list of tertiary procedures. All else equal, distributing new programs to counties where they already exist is reasonable in light of the goal of improving geographic accessibility of advanced cardiology services. As with the other draft proposed rule changes, there is no certainty that any programs will be approved on the basis of the county-specific need formula in (7)(c). These proposed programs would still have to meet the statutory and rule criteria. As discussed above, a number applications for programs have been ultimately denied even when presumed need was shown by the need formula. We recommend adoption of this additional formula for demonstrating need. (IRMH Ex. 1, p. 25, Comments of Ronald Luke, J.D., Ph.D., 10/24/2000) In what could be interpreted as an admission that the process resulting in the development of the earlier drafts was flawed, Jeff Gregg, Chief of the AHCA CON Bureau, concluded the January public hearing by saying, . . . in terms of the analysis that the Agency did about the proposed rule, I would simply have to tell you that CON staff was not involved in that analysis, and that's CON staff including myself. So I cannot elaborate on what went into it. But having said that, I do want to assure you that CON staff will be involved in further analysis and we will do our best to consider all the points that have been made and present them as clearly and concisely as we can in assisting the Agency to formulate its response to this hearing. (AHCA Ex. 7, p. 86). The December draft was also challenged by a number of Petitioners in DOAH Case No. 01-0372RP, filed on January 26, 2001, and ten other consolidated cases. In response to the criticism that the adverse impact provision should not have been deleted and because that omission was unintended, AHCA published another proposed amendment to the OHS rule, on May 4, 2001, reinstating a minimum adverse impact volume, this time set at 250 OHS operations, down from 350 in the existing rule. On May 31, 2001, AHCA and the other parties to DOAH Case No. 01-0372RP and the consolidated cases entered into another settlement agreement, which provided: that in an effort to avoid further administrative proceedings, without conceding the correctness of any position taken by any party, and in response to materials received in to the record on or before the public hearing, the Agency for Health Care Administration agrees to publish and support . . . The Notice of Change . . . (Bethesda Ex. 34, p. 2-3). In upholding that agreement, AHCA superseded or revised all prior drafts and published a notice of change on June 15, 2001. In this final version, AHCA limited normal approval of a new OHS program to one at a time, used 500 as the numeric need formula divisor, increased the required prior-to-approval OHS minimum volume at mature existing providers from 250 in the October version to 300 (down from 350 in the existing rule) and for non- mature programs from a monthly average of 21 in the October draft to 25 (down from 29 in the existing rule), retained the classification of OHS as a tertiary service, and altered the separate, independent county need methodology to make it a county preference. The June 15th version, containing Subsections 7(c) and 7(d), which are challenged in this case is as follows: Adult Open Heart Surgery Program Need Determination. An additional open heart surgery programs shall not normally be approved in the district if any of the following conditions exist: There is an approved adult open heart surgery program in the district; One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 300 adult open heart surgery operations during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; One or more of the adult open heart surgery programs in the district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than an average of 25 adult open heart surgery operations per month. * * * Provided that the provisions of paragraphs (7)(a) do not apply, the agency shall determine the net need for an additional adult open heart surgery programs in the district based on the following formula: NN=[(POH/500)-OP]> 0.5 where: NN = the need for an additional adult open heart surgery programs in the district projected for the applicable planning horizon. The additional adult open heart surgery program may be approved when NN is 0.5 or greater. POH = the projected number of adult open heart surgery operations that will be performed in the district in the 12-month period beginning with the planning horizon. To determine POH, the agency will calculate COH/CPOP x PPOP, where: COH = the current number of adult open heart surgery operations, defined as the number of adult open heart surgery operations performed in the district during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool. CPOP = the current district population age 15 years and over. PPOP = the projected district population age 15 years and over. For applications submitted between January 1 and June 30, the population estimate used for CPOP shall be for January of the preceding year; for applications submitted between July 1 and December 31, the population estimate used for CPOP shall be for July of the preceding year. The population estimates used for COP and PPOP shall be the most recent population estimates of the Executive Office of the Governor that are available to the agency 3 weeks prior to publication of the fixed need pool. OP = the number of operational adult open heart surgery programs in the district. In the event there is a demonstrated numeric need for an additional adult open heart surgery program pursuant to paragraph (7)(b), preference shall be given to any applicant from a county that meets the following criteria: None of the hospitals in the county has an existing or approved open heart surgery program; and Residents of the county are projected to generate at least 1200 annual hospital discharges with a principal diagnosis of ischemic heart disease, as defined by ICD-9- CM codes 410.0 In the event no numeric need for an additional adult open heart surgery program is shown in paragraphs (7)(a) or (7)(b) above, the need for enhanced access to health care for the residents of a service district is demonstrated for an applicant in a county that meets the criteria of paragraph (7)(c)1. and 2. above. An additional adult open heart surgery program will not normally be approved for the district if the approval would reduce the 12 month total at an existing adult open heart surgery program in the district below 300 open heart surgery operations. Bethesda objects to Subsections 7(c) and 7(d) as invalid. It challenges the rule promulgation process as a sham, having resulted from settlement negotiations rather than from statutorily mandated considerations and processes. That charge was, in effect, conceded by AHCA, as related to the October draft. That version carried over into the December draft, essentially unchanged, but did gain support at the October workshop. The October and December versions are not at issue in this proceeding. The proposed rule amendments at issue in this proceeding must have been supported by information provided to AHCA before or during the January public hearing. The proposal at issue differs substantially from the terms of the September settlement agreement, but is precisely what was attached to the May 31, 2001, settlement agreement. For example, the settlement agreement of September 11, 2000, included a proposal to reduce the prior minimum volume of cases at existing OHS providers from 350 to 250, but in May and June, that number was set at 300. AHCA, in the September settlement agreement, was to eliminate any limitation on the number of additional programs approved at a time, but the May and June version retains the one-at-a-time provision of the existing rule. AHCA agreed to determine county numeric need independent of and in addition to district numeric need, in September, but that provision is, in the May 31st and June 15th version, a preference. In September 2000, AHCA agreed to delete adult OHS from the list of tertiary services in Rule 59C-1.002(41), but it is a tertiary service in the May and June version. Bethesda is correct that the records of the October workshop and January public hearing contained criticisms of the county need methodology but no specific proposal to modify it into a preference. The first draft of that concept is the May 31, 2001, settlement agreement. (See Findings of Fact 26 and 27). Statutory rule-making issues Subsection 408.034(3), Florida Statutes, provides that: The Agency shall establish, by rule uniform, need methodologies for health care services and health facilities. In developing uniform need methodologies, the agency shall, at a minimum, consider the demographic characteristics of the population, the health status of the population, service use patterns, standards and trends, geographic accessibility, and market economics. As required by statute, AHCA considered the demographics and health status of the population and examined, as a part of the rule adopting process, age-specific calculations of ischemic heart disease. AHCA relied on statistical evidence of the relationship of ischemic heart disease and OHS. In 1999, for example, there were 33,027 OHS in Florida, and 25,257 of those patients had a primary diagnosis of ischemic heart disease. Consideration of service use patterns, and standards and trends related to OHS led AHCA to increase the divisor in the numeric need formula to maintain the average size of 500 surgeries for existing providers. The availability of more reliable data than that collected when the existing rule was promulgated allowed AHCA to propose reliance on residential use rates. The trend towards the use of angioplasty, as a preferred treatment for heart attack patients, and the need for timely geographical access to care are major factors for AHCA's proposal to consider a county services within the normal need analysis or as a not normal indication of a need for enhanced access when a county has a critical mass of heart disease patients. Geographical accessibility is also addressed in the travel time standard in the existing rule, which the proposal would not change. AHCA received testimony on the issue of market economics and health status, related to care for indigent and minority patients in not-for-profit, county-funded hospitals, and related to reimbursement formulas. The record demonstrates that AHCA was provided with evidence on the effect of scare resources on the costs of operating OHS programs. County-specific need methodology in earlier drafts as compared to the county preference in 7(c) and the need for enhanced access in 7(d) Bethesda alleges that the county preference in the June version is essentially another need methodology, like the county-specific need methodology in the earlier versions of the proposed rule. Bethesda also contends that a preference for a hospital because it is in a county which does not have an open heart program over a reasonably accessible facility in an adjoining county in the same district is irrational health planning which could lead to a maldistribution of programs. The county-specific need methodology was first included in the September settlement agreement, and the preference in 7(c) and need for access in 7(d), originated after the January 17, 2001, public hearing. During the public hearing, counsel for the Florida Hospital Association complained that the county-specific need methodology precluded any inquiry into accessibility and volumes at adjoining programs. Another representative of the Florida Hospital Association surmised that the goal of the county exemption was improved access but explained that it was an inappropriate means to identify access concerns. For example, while Hernando County would qualify for need with the separate methodology, most of its residents, 97 percent receive OHS services at a hospital in another district which is only 13 miles from the population center. (See Finding of Fact 26). The preference under normal circumstances in Subsection 7(c) and finding of need for enhanced access in Subsection 7(d), must be supported by evidence that county boundaries, in general, do create valid access issues. On or before the January workshop, information provided to AHCA indicated that some special inquiry into access issues related to CON applications for programs in counties without OHS programs is warranted. See Finding of Fact 27). AHCA found correctly that counties matter for several reasons. First is the fact that emergency services are funded and organized by counties, in general, and operated by municipal and county agencies. Approximately 60 percent of heart attack patient discharges in Florida are admitted through emergency rooms. Emergency heart attack patients who live in counties with OHS programs are twice as likely to be taken to a hospital with OHS as those who live in counties without an OHS provider. Second, whether a patient is taken to an OHS provider affects the care received. The probability of having an angioplasty performed is almost 50 percent greater for residents of counties with OHS programs as compared to those in counties without an OHS program. Third, some health care reimbursement plans and health care districts are operated within counties, limiting financial access to out-of-county hospitals. AHCA has always considered whether or not a county has an OHS program as a part of access issues. The issue of greater access to OHS was the basis for AHCA's initial consideration of the possibility of easing the OHS rule. With the May and June draft, it has codified and specified when that policy will apply. AHCA's deputy secretary noted that geographic access in the absence of numeric need was the basis for approvals of OHS CONs for Marion County, and for hospitals located in Naples and Brandon. In each instance, the applicants argued a need for enhanced access. AHCA has experience in applying preferences as a part of balancing and weighing criteria from statutes, rules and local health plans, particularly to distinguish among multiple applicants. In the totality of the review process, other factors which Bethesda's expert testified should be considered, including financial, racial and other potential access barriers, are not precluded. Preferences related to specific locations within health planning areas are included in CON rules governing the need for nursing home beds and hospices. Bethesda noted that these are not tertiary services, suggesting that a county location preference is inappropriate for tertiary services, but similar preferences for OHS exist in some of the local health plans. In AHCA District 1, the CON allocation factors for OHS and cardiac catheterization services include a preference for applicants proposing to locate in a county which does not have an existing OHS program. In District 4, the preference favors an applicant located in a concentrated population area in which existing programs have the highest area use rates. District 5 is similar to District 4, supporting OHS projects in areas of concentrated population with the highest use rates. The District 8, like District 1, preference goes to the applicant located in a county without an OHS program. There is no evidence that the existing preferences have been difficult to apply within the context of other CON criteria for the review of OHS applications. In effect, the proposed amendments establish an uniform state-wide county preference which is more concrete in terms of the requirements for a potential patient base. Bethesda has questioned the rationale for standards which are, in effect, different in Subsection 7(c) as compared to Subsection 7(d). The lower requirement, according to Bethesda, 1200 ischemic heart diagnoses, in 7(d), applies when there is no numeric need. But, the 500 divisor and 300 minimum at existing providers, when combined with 1200 ischemic heart diagnoses is a heavier burden to meet in 7(c), although under normal circumstances. Bethesda did not adequately explain reasons for this objection to the proposed rule. In addition, it is not inconsistent logically for AHCA to require applicants to demonstrate lower numeric need in situations in which AHCA has determined that these will be, in general, a greater need for enhanced access. Bethesda also raised a concern for the eventual maldistribution of programs as a result of the county preference. In 1999, Palm Beach county residents received 2700 OHS, or an average of 900 cases for each of the three programs. The total for District 9 was 3800 cases in 1999. When 500 St. Lucie County resident cases, in which Lawnwood is an OHS provider, are combined with 2700 Palm Beach resident cases, that leaves only 650 resident cases from Okeechobee, Indian River and Martin Counties. If programs are approved in all three, then the total will be inadequate for each to reach 300 cases, while, presumably, the demand in Palm Beach could be increasing disproportionately and not be met adequately. Disproportionate need, the appropriate dispersion of programs, and the benefits of enhanced competition are among the factors which AHCA can consider along with county need when choosing among competing applicants. 1200 ischemic heart disease discharges The proposed amendments require a projection that residents will reach a threshold of 1200 cases of ischemic heart disease discharges as a condition for the entitlement to the numeric need preference or to demonstrate a not normal need for enhanced access. In general, ischemic heart disease, which is also known as coronary heart disease, is characterized by blocked arteries which, in turn, limit blood to heart muscles causing first the onset of angina from acute coronary syndrome, progressing on to acute myocardial infarction, or a heart attack. The use of heart disease as a proxy for OHS utilization is consistent with AHCA's use of live births in pediatric open heart surgery and pediatric cardiac catheterization rules, deaths in the hospice rule, and related diagnoses in organ transplantation rules rather than actual utilization. It was supported by information received during or before the January workshop (See Finding of Fact 26 and 27). Bethesda's criticism of the use of a proxy per se is also not well-founded because any single statistical approach could be misleading. For example, historic use rates can understate future use with a growing service or an artificially imposed access limit. Using heart disease data in a preference or a need for enhanced access as opposed to a need formula or conclusive finding allows more flexibility in determining need in conjunction with other significant factors. One of Bethesda's expert health planners was also critical of the use of 1200 ischemic heart disease diagnoses as inadequate for projecting OHS cases, and for not equating to approximately 300 annual OHS cases, the minimum required of existing providers in Subsection 7(a) and the minimum adverse impact allowed in Subsection 7(e). Based on actual historical Florida data, 1200 ischemic heart disease diagnoses on average resulted in 207 OHS in 1997, 203 in 1998, and 203 in 1999. Ischemic heart disease has approximately an 18 to 20 percent conversion rate to OHS, and results in a total of 76 to 80 percent of all OHS cases. OHS cases from other diagnoses added statistically another 54 OHS in 1997, 59 in 1998, and 61 in 1999, to those from ischemic heart disease, giving, in each year a total less than 300. Bethesda presented evidence of wide variations in the ischemic heart disease to OHS conversion ratios from county-to- county. For example, only 14 percent of Bradford County ischemic heart diseases converted to OHS, and only 11 percent of the 700 cases in Columbia County converted to OHS. In Columbia County, the average state conversion rate of 20 percent yields 140 cases but, in reality, there were only 78 OHS cases from Columbia County in 1999. Bethesda's expert concluded that conversion ratio discrepancies resulting in the approval of a program that cannot achieve 300 OHS, as required in Subsection 7(a)2. and 7 (e), of the proposed rule, could bar the approval of new programs when needed in the district and would not be of minimum required quality. Bethesda also proved that the accuracy of projected OHS cases can also be affected by patterns of patient migration for health care, particularly if in- and out-migration do not offset each other. In counties with OHS programs, the average out-migration for acute care is 10.7 percent, varying widely from 3.8 percent in Alachua County to 70 percent in Seminole County. In counties without an OHS provider, average out- migration for acute care is 44 percent, but ranges from 17.6 percent in Indian River County to 98 percent in Baker County. An average of 18 percent of the residents of Florida counties with OHS programs have their surgeries performed elsewhere. Like out-migration, in-migration for acute care, for ischemic heart disease care, and for OHS varies from county to county in Florida. Counties without OHS programs have acute care in-migration from lows of 5.3 percent for Flagler County up to highs of 40 percent for Columbia County. In counties with OHS, in-migration for acute care is as low as 8 percent for Brevard and Polk, and as high as 60 percent for Alachua County. Similarly, in-migration, as determined by ischemic heart disease discharges averages 19.4 percent in counties without OHS programs and approximately 25 percent in those with OHS. In-migration for OHS, averages 35.7 percent for the state, but that is derived from a range from 9.2 percent in Pinellas County to 74 percent in Alachua and Leon Counties. Bethesda demonstrated, patterns of migration for health care vary throughout Florida, but there are trends due to the presence of OHS programs. Average net in-migration to counties with OHS is 29 percent, and is positive in sixteen of the twenty-four counties with OHS programs. All of these differences can be considered within the regulatory scheme proposed by AHCA. The issue of whether 1200 residential ischemic heart disease diagnoses is, in fact, the critical mass of prospective OHS patients needed or is deceptive due to migration patterns, due to access to alternative providers or any other review criteria listed in rule or statutes can be considered on a case-by-case basis with the proposed amendments. Bethesda's specific concern is that Indian River with well over 1200 ischemic heart disease discharges could be approved even though that represented only 255 OHS cases, and that if Indian River is approved under the county preference provision, then Bethesda would not be approved under normal circumstances until Indian River achieved and was projected to maintain 300 OHS cases a year. That Bethesda may be delayed in meeting the requirements for normal need is likely, but that appears to be a function of its location as compared to existing providers as much as it is the result of the county preference. Bethesda is not precluded, however, under either the existing or proposed rules from demonstrating not normal circumstances in District 9 for the issuance of an OHS CON to Bethesda. Bethesda's assumption that 300 is the minimum volume required for adequate quality is not supported by studies from various professional societies. The American College of Cardiology, the American Heart Association, and the Society of Thoracic Surgeons set minimums of 200 to 250 annual hospital cases as the volumes necessary to maintain the skills of the staff. The American College of Surgeons, in 1996, published their opinion that 100 to 125 cases per hospital is sufficient for quality, while at least 200 cases a year are needed for the economic efficiency of a program. AHCA has never used the required and protected volumes as the volume which must also be projected for a new programs. In the current OHS rule, the volume required is 350 a year for existing programs but that has not been required of applicants. In the recent approval of an OHS CON for Brandon Regional Hospital, the applicant projected reaching 287 cases in the third year of operation. County preference, tertiary classification and travel time Bethesda argued that the tertiary classification, suggesting a regional approach, is inconsistent with having a county access provision. Bethesda correctly noted that the county provision first appeared in a draft which included the elimination of OHS from the list of tertiary services. But AHCA proposes to establish the county preference and to maintain OHS on the list of tertiary services under Rule 59C-1.002(41), and to maintain the two-hour drive time standard in Rule 59C- 1.033(4)(a). Substantial information, mostly from medical doctors and studies linking morbidity to low volume, supports the view that OHS continues to be a complex service. Obviously, those services in the tertiary classification range in complexity and availability from OHS at the lower level to organ transplantation at the upper level. The tertiary classification is justified to assure AHCA's continued closer scrutiny of OHS CON applications. It is also consistent with the increase in the need formula divisor to 500, which together serve as restrains on the approval of additional programs. AHCA reasonably concluded, based on case law and precedents with local health plan that it is not inconsistent to apply county preferences to OHS while it is classified a tertiary service. The two-hour travel time standard, is as follows: Adult open heart surgery shall be available within a maximum automobile travel time of 2 hours under average travel conditions for at least 90 percent of the district's population. The counties most likely qualify for the preference, based on meeting or exceeding 1200 residential ischemic heart disease diagnoses, are Citrus, Martin, Hernando, St. Johns, Highlands, Indian River, and Okaloosa. The population centers in each of these counties are well within two hours of an existing provider. Citrus County, in which there is an approved but not yet operational OHS program, is about an hour's drive from Marion County. Hernando is approximately 25 minutes from the Pasco County provider. The population center of St. Johns County is approximately 40 minutes away from Duval County OHS providers. Okaloosa County is approximately a one-hour drive away from Escambia County OHS providers. In District 9, Indian River is approximately a 30- minute drive from the Lawnwood OHS program. Martin Memorial, is an approved provider, is approximately 20 miles or 35 minutes from Lawnwood and 30 miles or 40 minutes from Palm Beach Gardens, another existing OHS provider. In the next three to five years, it is foreseeable that Okeechobee County in northwestern District 9 could qualify for the county preference. Adjacent to Okeechobee, Highlands County's population can drive either an hour and thirty minutes to a Charlotte County OHS program or an hour and twenty minutes to a Polk County facility. The evidence related to travel times, according to one of Bethesda's experts, demonstrates that the county preference is not needed to assure access which is already provided for each and every likely qualifying county. But the population centers in the entire state of Florida are all within the two- hour travel standard, and there has been no suggestion that Florida cease approval of new OHS programs. Bethesda's contention that no need exists for enhanced access if the travel time standard is met, and its claim that the rule is internally inconsistent with a county preference and two-hour drive time are rejected. Two hours is, as the rule clearly states, a "maximum" not a bar, and has never been interpreted by AHCA as a bar, to more proximate locations. Any other interpretation is an impossibility considering the numerous counties across the state with multiple programs, including Dade, Broward, Palm Beach, Hillsborough, Pinellas, Orange, Volusia, Duval, and Escambia, among others. AHCA can appropriately and consistently establish reasonable guidelines for choosing among applicants to enhance access within the maximum travel standard. There is no language in the proposed rule indicating when it will take effect. Although the issue was raised in Bethesda's petition, it failed to provide evidence or legal arguments at hearing or subsequently to support its objection to the omission. AHCA's deputy secretary testified that the agency reviews applications using need methodology rules in effect when the applications are filed. Before new rules are applied, applicants are given the opportunity to reapply to address new provisions in a rule.
Conclusions The attending nurse's actions and inactions fell below the standard of professional care applicable under the circumstances. The consequences of a below normal fetal heart rate are so critical that, even if the nurse was suspicious that the monitor was not working properly, her proper response should have been to take immediate steps to determine whether the fetus was in distress, to intervene with resuscitation measures if needed, and to alert a doctor. Her failure to take appropriate action was negligence and was the proximate cause of the injuries suffered by Janaria. South Broward Hospital District, doing business as Memorial Regional Hospital, is liable as the nurse's employer. There are many reasons for entering into a settlement agreement other than the perceived merits of the claim and, therefore, I am not precluded from reviewing the terms of the parties' settlement agreement in this matter and determining whether they are reasonable under the totality of the circumstances. In this case, the settlement amount is far less than the usual jury verdict for injuries of this nature. Had this case involved a private hospital, the settlement amount would probably have been much larger. Therefore, I believe it would be fair and reasonable for the Senate to pay an award of $550,000 (or 50 percent more than the agreed settlement amount). ATTORNEY’S FEES AND LOBBYIST’S FEES: In compliance with s. 768.28(8), F.S., the Claimants' attorneys will limit their fees to 25 percent of any amount awarded by the Legislature. However, Claimants’ attorneys did not acknowledge their awareness of the provision of the bill that limits attorney’s fees, lobbyist’s fees, and costs to 25 percent of the award. They propose a lobbyist's fee that would be an additional 6 percent of any award. OTHER ISSUES: The bill should be amended to correct the name of the defendant to South Broward Hospital District. Of the two annuity options presented by the Claimants' attorney, I believe the option that guarantees payment for 40 years is the better option. In addition, because Shakima Brown received nothing in the settlement, I believe the bill should specify that, in the event that Janaria dies before the trust fund is exhausted, the balance in the trust fund should go to Ms. Brown. The District stated that paying a claim in the amount of $300,000 would not impair its ability to provide normal services. RECOMMENDATIONS: For the reasons set forth above, I recommend that Senate Bill 38 (2008) be reported FAVORABLY, as amended. Respectfully submitted, cc: Senator Ted Deutch Representative Kelly Skidmore Faye Blanton, Secretary of the Senate Bram D. E. Canter Senate Special Master House Committee on Constitution and Civil Law Tony DePalma, House Special Master Counsel of Record
The Issue The issues in this case are whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes (2000),1 and, if so, what discipline should be imposed.
Findings Of Fact The Department is the state department charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes (2006). At all times material to this proceeding, Dr. Figueroa was a licensed physician within the State of Florida, having been issued license number ME 60819. Dr. Figueroa is board- certified in Family Practice. At all times material to this proceeding, Dr. Figueroa was the supervisor and employer of mid-level provider Carl Sellers, P.A. (Mr. Sellers). G.C., a 33-year-old male, first presented to Mr. Sellers as a new patient on November 14, 2000. G.C. complained of a two-month history of coughing, low-grade fever, fatigue, and heavy breathing. G.C.'s temperature was 98.4, his weight was 181 pounds, and his heart rate was 68 beats per minute. Mr. Sellers conducted an examination of G.C. and noted that G.C. was having difficulty taking a deep breath, shortness of breath on inspiration that was better if standing upright, severe fatigue, and fits of couching where he nearly vomited. Mr. Sellers also noted that G.C. had mild lymph adenopathy. Mr. Sellers' diagnosed G.C. with a persistent upper respiratory infection. He prescribed Zithromax and Guaifed TR and ordered a chest X-ray and blood testing, including a complete blood count (CBC) with differential, comprehensive metabolic profile (CMP), and erythrocyte sedimentation rate (ESR). G.C. was instructed to return in a week or sooner if he worsened. Dr. Figueroa's normal operating practice was to review Mr. Sellers' files of the previous day on the following morning. Dr. Figueroa reviewed G.C.'s medical record and concurred with Mr. Sellers' diagnosis. Laboratory results from the blood testing arrived in the office of Dr. Figueroa on November 20, 2000. G.C.'s blood testing results revealed abnormal liver function, anemia, borderline protein, and an abnormal sedimentation rate. The results of the blood tests did not warrant immediate follow-up with G.C. Mr. Sellers reviewed the laboratory report of the blood tests and indicated that he would discuss the results with G.C. on his next visit. G.C. was scheduled for a return visit on November 21, 2000, but called Dr. Figueroa's office and rescheduled his appointment for November 22, 2000. G.C. failed to keep his scheduled appointment. On November 22, 2000, Mr. Sellers reviewed the Radiological Report for G.C. The report stated: The lungs are clear of infiltrates. There is mild blunting of the costophrenic sulci probably representative of small effusions. The heart size is moderately enlarged. No pulmonary edema nor widening of the superior mediastinum detected. The impression of the radiologist was "moderate cardiomegaly with probably small pleural effusions." The Department's expert, Dr. Rafool, testified that the Radiological Report was an indication that G.C.'s heart was failing, which was inconsistent with the initial diagnosis of upper respiratory infection. Dr. Figueroa and his expert, Dr. Harold, testified that radiologists often "over read" chest X-rays; therefore, the Radiological Report did not warrant emergent action by Dr. Figueroa. Dr. Rafool countered the common over-read argument by testifying that regular radiologists do not equivocate because it causes more work for the ordering physician. The language of the radiologist is clearly intended to alert Dr. Figueroa to the presence of unusual conditions observed in G.C.'s chest X-ray that were inconsistent with an upper respiratory infection. Dr. Rafool's testimony is more credible concerning the significance of the Radiological Report and its implications on the diagnosis of G.C. Dr. Rafool testified that the Radiological Report indicated that G.C.'s heart was failing, which constitutes a "medical emergency" that required urgent notification of the patient. Dr. Figueroa and Dr. Harold conceded that the report indicated conditions that warranted "timely" follow-up, but not immediate intervention or contact with the patient. The Radiological Report revealed a "moderate" cardiomegaly that was an indication of cardiomyopathy, a heart condition that is more often fatal if not corrected by treatment that may include a heart transplant. Since early intervention is likely to lead to an opportunity for a favorable outcome, the testimony of Dr. Rafool is more credible regarding the need for notification of the patient. The record does not indicate any affirmative effort by Dr. Figueroa, his staff, or by Mr. Sellers to contact G.C. between November 22 and November 27, 2000, which was the next time that G.C. presented to Dr. Figueroa's office. On November 27, 2000, G.C. was complaining of worsening conditions since November 23 including swollen legs, inability to sleep at night, and coughing with shortness of breath mainly at bedtime. G.C.'s temperature was 97.2, his weight was 188 pounds, and his heart rate was 114 beats per minute. Mr. Sellers conducted an examination of G.C. and noted definite lid lag with mild exophthalmia, crackles in the lungs with no wheeze, moderate jugular vein distention, orthopnea, grade +2 pitting edema, and no goiter. Mr. Sellers ordered a STAT EKG on G.C. The EKG indicated "sinus tachycardia with occasional ventricular premature complexes and possible left atrial enlargement." Mr. Sellers documented that G.C. might be suffering from left ventricular hypertrophy. Mr. Sellers' primary diagnosis of G.C. was hyperthyroid crisis (storm), his secondary diagnosis was mild congestive heart failure secondary to hyperthyroid crisis caused by high output failure, his third diagnosis was IDA, the fourth diagnosis was elevated liver function tests and bilirubin, and the fifth diagnosis was insomnia. Mr. Sellers mistakenly diagnosed G.C. with a hyperthyroid crisis. Mr. Sellers consulted with Dr. Figueroa, who also examined G.C. Dr. Figueroa concurred with the assessment, diagnosis, and treatment plan of Mr. Sellers, including the diagnosis of hyperthyroid crisis. He indicated on the EKG strip that he agreed with the findings of G.C.'s EKG. A patient in a hyperthyroid crisis requires immediate hospitalization. Dr. Figueroa did not hospitalize G.C. Mr. Sellers prescribed 40 mg of Lasix, daily; 40 mg of Inderal, twice daily; and 50 mg of propylthiouracil, three times daily. The propylthiouracil prescribed was an insufficient dose based on the diagnosis of hyperthyroid crisis. Dr. Harold testified that G.C. did not present clinical signs of pulmonary edema during Mr. Sellers' examination on November 27, 2000, based on a lack of acute distress, moist rales and rhonchi throughout the lung fields, and respiratory distress. Dr. Rafool opined that G.C. did present clinical signs of pulmonary edema based on the crackles in the lungs, neck vein distension, pitting edema, elevated heart rate, and weight gain. The Department has failed to establish by clear and convincing evidence that pulmonary edema was ever clinically apparent to Dr. Figueroa or Mr. Sellers. In fact, hours after G.C. was examined by Dr. Figueroa and Mr. Sellers, the emergency room physicians did not diagnose G.C. with pulmonary edema. Inderal is contraindicated in the presence of pulmonary edema. Since pulmonary edema was not clinically apparent, Inderal was appropriately prescribed. Mr. Sellers' diagnosis of mild congestive heart failure was incorrect. Based on the symptoms exhibited by G.C. of neck vein distension, weight gain, orthopnea, and grade +2 pitting edema, it should have been apparent that G.C. had severe heart failure. G.C. presented to the Bayfront Medical Center Hospital Emergency Room at 10:03 p.m. on November 27, 2000. G.C. complained of abdominal pain and swelling, nausea and vomiting, and difficulty breathing. Examination of G.C. by emergency room personnel revealed the presence of bibasilar rales, but good breath sounds. Hospital chest X-ray revealed cardiomegaly, no infiltrates. At 1:33 a.m. on November 28, 2000, G.C. went into cardiac arrest. G.C. was pronounced dead at 3:04 a.m., November 28, 2000. An autopsy performed on G.C. revealed dilated cardiomyopathy, bi-ventricular dilation, pulmonary edema, and congested liver. The immediate cause of death was listed as idiopathic dilated cardiomyopathy. The autopsy report indicated that G.C. also had pulmonary edema; however, the pulmonary edema could have resulted from the large amounts of fluids that were being administered to G.C. by hospital staff during the last few hours of G.C.'s life. Dr. Figueroa was notified of G.C.'s demise on November 28, 2000, and he immediately sent his medical records on G.C. to his legal counsel without making any further notations on the records.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered finding that Dr. Figueroa violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes; suspending his license to practice medicine until he completes the Florida C.A.R.E.S. program or a comparable physician skills assessment program to assess his clinical skills; requiring compliance with the program's recommendations; placing him on two years' probation with direct supervision to be set by the Board of Medicine; and imposing an administrative fine of $10,000. DONE AND ENTERED this 13th day of December, 2006, in Tallahassee, Leon County, Florida. S SUSAN B. HARRELL Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 13th of December, 2006.
Findings Of Fact The Respondent is a licensed medical doctor holding license number 0013446 issued by the Florida Board of Medical Examiners. He specializes in internal medicine, geriatrics, endocrinology and nuclear medicine with an extensive educational and professional background in those fields. He is currently in private practice in Dade County, Florida. The Petitioner is an agency of the State of Florida charged by Chapter 458, Florida Statutes (1981), with administering, regulating, and enforcing the licensure and medical practice standards as delineated by that chapter and related rules. Maurice Blanchar was examined at the Miami Heart Institute in 1976. At that time it was suggested by his attending physician that Mr. Blanchar have a "nuclear scan" because of a suspected abnormality described as "Gallin Syndrome." Mr. Blanchar was also examined at the Cooper Clinic in Dallas, Texas, in 1979, at which time it was also suggested that he have a nuclear scan (apparently related to cardiac complaints at that time of an unspecified nature). A coronary angiogram was performed at the Cooper Clinic, which was within normal limits. Sometime in 1979, Mr. Blanchar, with a prior history of undiagnosed cardiac complaints, read an advertisement in a local newspaper which offered nuclear scans to be performed by the Respondent, Dr. Sternberg. Mr. Blanchar kept this advertisement in his possession for approximately one year and ultimately called the Respondent's office for an appointment in July of 1980. Upon obtaining his appointment, Mr. Blanchar was advised to bring $95 as a initial fee, together with proof of medical insurance coverage. Upon arriving for his scheduled appointment at the Respondent's office, Mr. Blanchar executed a questionnaire designed to disclose his medical history. His specific presenting complaint was that he was suffering chest pains. He was a regular "jogger" and had no pain or discomfort attendant to this exercise, but suffered chest pains only while resting in bed at night. He met with the Respondent and informed the Respondent that he was responding to the advertisement regarding "nuclear scans" and informed the Respondent of his complaint, a somewhat unusual occurrence. Based upon Mr. Blanchar's complaints, together with information discerned from Mr. Blanchar's previous records from the Cooper Clinic and the Miami Heart Institute, Dr. Sternberg discussed the procedures he intended to perform with Mr. Blanchar. Dr. Sternberg informed him of the tests he would perform before and as he was performing them. Dr. Sternberg explained, and Mr. Blanchar admitted in his testimony, that the $95 fee was not for the entire nuclear scan series of tests performed, but was rather for a consultation and initial examination performed by the Respondent. The record does not clearly reflect whether specific fees for tests or procedures to be performed were discussed between the Respondent and Mr. Blanchar at this time, other than the Respondent informing Mr. Blanchar that his insurance company would pay for the cost of the nuclear scans involved. Prior to beginning the testing, the Respondent had no presupposition that Mr. Blanchar had cardiac arterial disease, based upon a previous normal coronary angiogram, and the symptoms of lack of pain while jogging, but pain while at rest in bed at night. Dr. Sternberg was aware that Mr. Blanchar was a jogger, which indicated to the Respondent that in terms of likelihood, his chances of having coronary artery disease were extremely small in terms of percentages. However, the fact that he developed chest pains while at rest in bed, led Dr. Sternberg to believe that this symptom could possibly be related to coronary artery disease. Because of the possibility of a hiatal hernia, arthritis, or possibly a congenital heart lesion, the Respondent performed three tests, the so-called "first pass," "MUGA at rest" and "MUGA at stress." All tests were designed to give complementary information, which information is not necessarily achievable by any one procedure in and of itself. The first procedure performed was the cardiac imaging blood pool test, commonly referred to as a "first pass study." It is the function of this test to assess the pattern of blood flow through the heart to determine right and left ventricular performance which is measured by cardiac wall motion and "ejection fraction." The first pass test is also utilized if there is a suspicion of vascular misformation, obstruction or shunting in a patient's heart. The first pass test was found to yield results within normal limits. The next procedure performed by the Respondent was the cardiac imaging, gated, static test, designed to show cardiac wall motion and ejection fraction, which last term is related to the volume of blood pumped by the heart upon ventricular contraction. This procedure is commonly termed the "MUGA at rest" study. The main concern of this test is a measurement of cardiac function as observed by wall motion of the heart and measured by the ejection fraction while the patient is at rest. This procedure is most commonly done as a baseline study for obtaining information concerning cardiac function while the patient is at rest for purposes of comparison with the cardiac imaging, gated, wall motion, ejection fraction test done with the patient at stress. This latter test is referred to as "MUGA at stress" and is performed in the case of patient Blanchar by using the so-called "Cold Presser Method," which involves stressing the heart to the required degree for the test by fastening an ice bag on the arm of the patient until he has reached the level of stress desirable for performing the MUGA at stress test. The MUGA at stress performed by the Cold Presser Method, although somewhat experimental, is an accepted means of inducing cardiac stress in the patient for purposes of obtaining meaningful MUGA at stress results. The MUGA at stress test, when used in conjunction with the MUGA at rest study, gives the physician a comparison of relevant data concerning cardiac function. Dr. Sternberg was the primary treating physician for Mr. Blanchar. He did not see him on a referral basis from any other physician with any attendant request to do a specific or narrow diagnostic service. Rather, Mr. Blanchar presented himself with a complaint of chest pains at night while at rest, therefore Dr. Sternberg had a broader range of potential problems to consider in determining which diagnostic test to perform on Mr. Blanchar. When Dr. Sternberg performed the first pass test, which was performed first of the three tests performed on patient Blanchar, the ejection fraction was normal, but on the lower side of a normal range for this patient. Dr. Sternberg and the Respondent's expert witness, Dr. Epstein, as well as Dr. Gottlieb testifying for the Petitioner, established that the first pass test is medically indicated to rule out problems such as "shunting," obstructions or regurgitation. Dr. Sternberg had no prior medical history of Mr. Blanchar which would automatically rule out any such problems and, in the exercise of sound medical judgment, felt that the first pass test should he performed. The decision to perform this test was medically appropriate given the patient's symptoms and the doctor's responsibility as the only primary care physician involved. Dr. Sternberg then performed the MUGA studies at rest and at stress and found that the wall motion of the heart looked normal in the left anterior oblique view. The ejection fraction was normal with the MUGA study "at rest" test, but was higher in the normal range than had been the case with the first pass study, which led him to believe that the previous first pass study had an anxiety factor in the patient as a contributing factor to its results. Thus, the MUGA at stress test was able to confirm the efficacy of the performance of and results of the first pass study and Dr. Sternberg was, as well, able to rule out any problems related to shunting, regurgitation, or obstruction in the patient. He was able to confirm that the first pass study, with the patient's anxiety as a factor, had resulted in a slightly altered ejection fraction result. In any event, after these two tests were performed, he also felt the need to look at the wall motion of the heart, under stress conditions in the other areas of the heart, because he had not yet found any area of abnormality. Ultimately, no substantial abnormality was found in the patient's heart, except a suggestion that stress altered his ejection fraction. He also found that the wall motion of Mr. Blanchar's heart in the region of the left circumflex branch, the posterior laterial wall, towards the apex, showed sluggish motion, in fact, almost a paradoxical type of motion during stress, as compared with the baseline study which indicated that there was evidence of probable coronary artery disease at that point. Dr. David Allen Epstein practices diagnostic radiology and nuclear medicine. He was accepted as an expert witness on behalf of the Respondent and largely corroborated the Respondent's testimony, finding the procedures performed by Dr. Sternberg for patient Blanchar to be medically legitimate and to constitute matters of clinical judgment. Dr. Epstein established that the Respondent had available to him other justifiable tests beyond those he performed for Mr. Blanchar and established that the first pass, MUGA at rest and MUGA at stress studies performed, were for medically justifiable reasons and, in a patient with the presenting symptoms of Mr. Blanchar, were each designed to elicit information not directly available from the other tests. The use of color for cardiac computer studies is a useful diagnostic procedure. Neither Dr. Stuart Gottlieb nor Dr. Stolzenberg (Petitioner's expert witnesses) found any fault with the management or care provided these patients, nor the choice of tests performed by Dr. Sternberg with the exception of the first pass test and the separately billed stress test. Both Drs. Gottlieb and Stolzenberg felt the first pass test was redundant. However, their testimony in this regard is rejected and Dr. Epstein's and the Respondent's is accepted, inasmuch as the Respondent was the primary care physician and the only physician concerned with these proceedings who saw the patients in a clinical setting, charged with evaluating the patient's own complaints and arriving at a diagnosis. Patient Blanchar was not presented to the Respondent by another referring physician upon a narrow area of specific inquiry, rather Dr. Sternberg had to perform the added first pass study in order to rule out possible shunting, obstruction, regurgitation and other problems and his testimony regarding the necessity for this is corroborated by that of his expert, Dr. Epstein. It was established that all three cardiac studies were efficacious with regard to patient Blanchar and the Respondent's testimony and Dr. Epstein's testimony is accepted to the exclusion of other testimony in this regard. The Respondent's bill presented to patient Blanchar (and presumably his insurance carrier) is set forth in Petitioner's Exhibit "A" and reflects the following charges: Comprehensive office visit, new patient $ 95.00 Stress testing 150.00 Provision of Radionuclide 20.00 Cardiac Imaging gated (wall Motion, ejection fraction) w/stress 500.00 Cardiac Imaging gated (wall Motion, ejection fraction) static 500.00 Cardiac Imaging blood pool (1st pass) and or vascular flow 500.00 Dr. Sternberg charged patient Blanchar an additional $150 for "stress testing" which is represented on his bill to be a separate and different test from the cardiac imaging, gated, wall motion study with stress or "MUGA at stress," for which the doctor charged Blanchar $500. Although the Respondent represented that this "stress testing" was a separate service performed, there is no evidence whatever in the record which would establish that such a stress test was performed separate and apart from the MUGA at stress, performed for the $500 charge. A separate stress test would have been redundant and unnecessary in any event. It is obvious therefore that the patient Blanchar was billed for a separate item called "stress testing" in the amount of $150 which was not actually performed and which was not necessary. Dehlia Teramo suffered an automobile accident on March 12, 1980. She was initially seen by Dr. Carlos B. Fernandez, who saw her on the day of the accident. He ultimately referred Ms. Teramo to the Respondent with a history of trauma sustained in the accident with subsequent pain throughout her head, ears, eyes, neck, nose, and left shoulder. On April 10, 1980, Ms. Teramo initially saw the Respondent complaining of frequent headaches, neck pain, eye pain, high blood pressure, back and shoulder pains and pain in her nose, having sustained trauma and unconsciousness after being thrown about in the interior of her car during the auto accident. She additionally suffered pain in the left upper and lower parts of her mouth and suffered a recurrence of her menstrual period. Dr. Fernandez sent her to the Respondent for evaluation and diagnosis with reference to all these physical complaints, including the possibility of a fracture in the head or left shoulder area, but not solely for determination of the presence of a fracture of the sphenoid bone of the head. The Respondent performed three diagnostic tests or studies on different dates to attempt to determine the basis of Ms. Teramo's injuries. The first study was conducted on April 10, a blood circulation study. This study, when confined to the cerebral area is known also as a brain flow study. The study was conducted by the Respondent in area of the head as well as the spine and shoulder. The test is performed by injecting the patient with a radionuclide and then following the "bolus" throughout the areas in the which the physician is interested in gathering data with an x-ray camera assisted by a computer. In effect, this test images the blood flow in the blood vessels involved in the head, spine and shoulder areas and is used to detect subdural or epidural hematomas, abnormal vascular changes in the brain and in the other areas tested. It is designed to show any breaks or "leaks" in the blood/brain barrier, that is, any passage of blood from the vascular system of the brain into surrounding brain tissue. In itself, it is not the primary test for determining a fracture, but it is useful and all expert witnesses agreed and established that it was within sound medical judgment and patient management to perform such a test to aid and ascertain the basis for the complaints Ms. Teramo had regarding her head, neck and shoulder areas. A sphenoid bone fracture would be difficult to diagnose with this one test alone, but that was not the sole basis for the referral of Ms. Teramo to the Respondent. The radionuclide which is injected travels throughout the patient's body and the physician can do a number of limited scans or a total body scan utilizing the one injection of radionuclide. In performing the blood circulation or blood flow study, the Respondent charged patient Teramo for each component of the study, in effect, each view taken was charged for as a separate procedure as was the injection of the radionuclide. The computer processing and color image analysis was also disclosed to patient Teramo to be a separate procedure and was billed for separately, as shown on Petitioner's Exhibit "K," the bill set forth below. The blood circulation study and the quantitative cerebral blood flow study were represented to the patient Teramo on the bill as being separate studies and a separate $200 charge was assessed against the patient for the quantitative cerebral flow study. These studies are performed during the same patient visit and utilizing the same injection of radionuclide. The cerebral blood flow study is dynamic, with imaging done as the radioactive "bolus" moves through the vascular area in question. The blood circulation study, also called blood pool study, is the static form phase of the procedure performed after the vascular system in the area in question has already been completely infused with radionuclide. The testimony of Dr. Stolzenberg, coupled with that of the Respondent himself, establishes that the quantitative cerebral blood flow study is indeed tested with the same injection of radionuclide at the same patient visit. It is a different test or procedure, however, although many practitioners do not use it and it is unusual to see it used. However, it was not demonstrated, because it is not a standard type of procedure, that a practitioner should not charge a separate fee for it, not that the brain flow study always necessarily includes a quantitative, cerebral blood flow study. Thus it was not shown that the quantitative, cerebral blood flow study with the separate charge of $200 on Ms. Teramo's bill was not a separately identifiable test performed on her. The Petitioner also was unable to establish that this particular test was not medically indicated for a patient with Ms. Teramo's presenting symptoms. On April 14, 1980, the Respondent performed another nuclear scan on patient Teramo, known as a bone scan. This is accomplished by again injecting the patient with a radionuclide substance which adheres to the bones and joints after passage of a period of time while the patient waits in the examining facility. This scan was utilized for the same areas as the previous scan or blood flow study, that is the head and left shoulder areas and cervical spine area. The bone scan is used to aid in the physician's determination of the presence of fractures. The Respondent separated his charges for this procedure into a separate charge for each view obtained, as well as a separate charge for the injection of the radionuclide, and a separate charge for computer processing and clinical color imaging analysis done by the Respondent himself. On April 18, 1980, the Respondent performed an echoencephalogram upon patient Teramo. This procedure is designed to determine the presence of subdural or epidural hematomas, fractures and tumors. It is commonly utilized in cases of patients who sustain traumatic injury. Having reviewed the results of all these procedures, the Respondent arrived at a diagnosis of patient Teramo as having a fracture of the sphenoid bone of the head. No apparent diagnosis was made with reference to the shoulder area. The Respondent presented a bill to patient Teramo, admitted as Petitioner's Exhibit "K," reflecting the following pertinent charges: 4/10/80 Initial consultation $ 95.00 Injection of Radio- nuclide for scans 20.00 Scans: (Blood circulation study) Head LL 75.00 Head PA 75.00 Head Vertex 75.00 Cervical Spine PA 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head AP 75.00 Head RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis 350.00 Quantitative Cerebral Blood Flow Study 200.00 4/14/80 Office visit 25.00 Injection of Radio- nuclide for scans 20.00 Scans: (Bone and Joint Study) Head AP 75.00 Head RL 75.00 Head LL 75.00 Shoulder AP 75.00 L. Shoulder AP 75.00 R. Shoulder PA 75.00 L. Shoulder PA 75.00 Head PA 75.00 Cervical Spine PA 75.00 Cervical Spine LL 75.00 Cervical Spine RL 75.00 Computer processing for high resolution and high sensitivity image produc- tion and clinical color image analysis. 350.00 4/18/80 Office visit 25.00 Echoencephalogram, A-Mode 150.00 The blood and bone scan studies done with regard to Ms. Teramo's complaints, as well as the echoencephalogram, are medically appropriate and a proper exercise of sound medical judgment by a clinical physician and primary treating physician in the position of Dr. Sternberg with regard to this patient. It must be remembered that Ms. Teramo was not merely presented for determining the presence of a sphenoid fracture, rather she was presented to Dr. Sternberg by Dr. Fernandez, for investigation of various types of suspected pathologies. Dr. Sternberg's testimony, as corroborated by that of Dr. Epstein, establishes that certain fractures not always detectable by specific types of radiographic techniques may be detected by the device of blood pool scans. The Respondent showed (corroborated to some extent by Drs. Gottlieb and Stolzenberg) that the tests performed on Ms. Teramo constituted matters of clinical judgment and that Dr. Sternberg had available to him other tests which he could have performed on Ms. Teramo or Mr. Blanchar and did not. Some physicians use color imaging in computer processing and that is a legitimate type of evaluation and diagnostic technique. Further, Dr. Stolzenberg recognizes that there are some physicians who do cerebral blood flow studies of the brain and charge fees there for and acknowledges that there is no prohibition against such a procedure and that some physicians use the aid of a computer during performance and evaluation of brain scans as a routine matter. Neither of the Petitioner's expert witnesses are primary care physicians and Dr. Stolzenberg admitted that he does not practice internal medicine; neither have examined either of Dr. Sternberg's patients concerned in this proceeding. Only Dr. Sternberg, of the three doctors involved, is a primary care physician. It has thus been shown that the first pass study, the MUGA at rest and the MUGA at stress studies, as well as the blood circulation study, quantitative cerebral blood flow study and bone scans performed on these two patients were medically legitimate and all were within an appropriate choice of tests and were selected and performed in a manner within acceptable medical standards. The fact that the Respondent charged a $75 fee for each of the various scans or views of the head, shoulders, and cervical spine of Ms. Teramo for purposes of the blood circulation study and the bone scans performed appears exorbitant, however there is no evidence that it was not a charge directly related to the Respondent's time and skill as a highly trained specialist, coupled with a component in each of those charges for the use of highly sophisticated, color, computer processing equipment and camera which he owned and operated himself in his own office. Since the specific rates charged by physicians for this and any other type of service, are not regulated, these charges cannot be delved into further for purposes of this proceeding once the diagnostic procedures to which they relate have been established, to be medically acceptable, which they have, with the exception of the $150 charged patient Blanchar for the unperformed stress test.
Recommendation Having considered the foregoing Finding of Fact, Conclusions of Law, the candor and demeanor of the witnesses and the pleading and arguments of the parties, it is, therefore RECOMMENDED: That the Board of Medical Examiners enter a Final Order finding the Respondent, Joshua L. Sternberg, M.D., guilty of a violation of Sections 458.331 (1)(1) and (o) Florida Statutes (1981), to the extent delineated above, and that he be fined the sum of $1,000 for each of the above two violations. DONE and ENTERED this 30th day of November, 1983, in Tallahassee, Florida. P. MICHAEL RUFF 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 November, 1983. COPIES FURNISHED: Harold M. Braxton, Esquire 45 S.W. 36th Court Miami, Florida 33135 Steven M. Slepin, Esquire 1114 East Park Avenue Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue The issues for determination in this proceeding are whether Respondent failed to practice medicine with that level of care, skill, and treatment of two patients which is recognized by a reasonably prudent similar physician as being acceptable under similar circumstances and whether Respondent failed to keep written medical records justifying the course of treatment of the two patients.
Findings Of Fact Petitioner is the state agency statutorily charged with the duty and responsibility for enforcing applicable statutes and administrative rules against physicians licensed by the State of Florida. Respondent is, and has been at all times material hereto, a physician licensed by the state, having been issued license number ME 0032342. Patient A.R. Patient A.R. is an elderly female who was approximately 80 years old when Respondent first examined her on January 8, 1987. Patient's chief complaint was a 10 year history of hypertension. Respondent diagnosed patient A.R. as suffering from hypertension and possible angina pectoris. The patient was using a pacemaker at the time she first saw Respondent. Respondent performed an EKG on patient A.R. on January 8, 1987, and determined that the patient's pacemaker was malfunctioning. Respondent performed an EKG on patient A.R. on June 14, 1987. Respondent misinterpreted the EKG as indicating that patient A.R. had a sinus rhythm, frequent ventricular premature complexes, marked rhythm irregularity, and a heart rate of 65 beats per minute. Respondent noted his diagnosis in patient A.R.'s chart. The EKG actually indicated that patient A.R. was suffering from a second degree heart block and that her heart rate was below 50 beats per minute. A second degree heart block is a condition in which the area in the heart which initiates the heart beat functions abnormally. In effect, the electricity is blocked from going into the heart and starting the heart beat. The patient's pulse rate is lower than it should be. Patient A.R. was suffering from a second degree heart block on June 14, 1987, and was not properly diagnosed by Respondent. 1/ Patient A.R. went to a hospital emergency room on June 19, 1987, with a very low pulse rate. She was admitted to the hospital and had a permanent pacemaker implanted. The standard treatment for a heart block is a pacemaker. There may be insufficient blood supplied to the brain of a patient who suffers from a heart block. If left untreated, a patient may experience fainting, cardiac arrhythmia, and death. Respondent failed to practice medicine with that level of care, skill and treatment of patient A.R. which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. After examining patient A.R. on June 14, 1987, and on June 16, 1987, Respondent failed to correctly interpret the EKG results on June 14, 1987, and failed to properly diagnose patient A.R. The written medical records that Respondent maintained on patient A.R. failed to justify the course of treatment for patient A.R. The records contained an incorrect reading of the EKG given on June 14, 1987, and failed to justify the course of treatment followed for patient A.R. Patient C. H. Patient C. H. is an elderly female who was 65 years old when she was first seen by Respondent on October 23, 1985. Respondent noted that patient C.H. had occasional rectal bleeding and chronic anemia. Respondent noted in the medical records that patient C.H. should have a rectum and colon study performed. However, no tests were ever conducted to determine the source of bleeding or to test the patient's stool for blood. On April 7, 1987, patient C.H. was examined by Respondent complaining of anal bleeding for 2 or 3 days. Her hemoglobin count was markedly low. On May 7, 1987, patient C.H. was examined by Respondent and stated that her anal bleeding decreased four days after her office visit on April 7th. On August 3, 1987, patient C.H. was hospitalized and found to be anemic. Respondent failed to practice medicine with that level of care, skill and treatment of patient C.H. which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. Respondent failed to perform any diagnostic tests or studies on patient C.H. between October 23, 1985, and August 3, 1987, to determine the source of her anal bleeding or to test her stool for blood. Respondent also failed to refer patient C.H. to a specialist for a gastrointestinal work-up. The written medical records that Respondent maintained on patient C.H. failed to justify the course of treatment for patient C.H. The records failed to include a justification for the course of treatment, the failure to conduct tests, or the failure to refer the patient to a specialist.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding that Respondent is guilty of violating Sections 458.331(1)(m) and (t), Florida Statutes, imposing an administrative fine of $3,000 against Respondent, and placing Respondent on probation for two years subject to such reasonable terms and conditions as the Board may impose. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 9th day of September, 1991. DANIEL MANRY 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 10th day of September, 1991.
The Issue Whether the second and third sentences of Rule 59C-1.033(7)(c), Florida Administrative Code, are invalid? If so, whether they may be severed from the remainder of the Rule?
Findings Of Fact Subparagraph (7)(c) of the Rule states: Regardless of whether need for a new adult open heart surgery program is shown in paragraph (b) above, a new adult open heart surgery program will not normally be approved for a district if the approval would reduce the 12 month total at an existing adult open heart surgery program in the district below 350 open heart surgery operations. In determining whether this condition applies, the Agency will calculate (Uc x Px)(OP + 1). If the result is less than 350, no additional open heart surgery program shall normally be approved. (Emphasis supplied to indicate the challenged portion of the Rule.) The first sentence sets forth the objective and intent of subparagraph (7)(c) of the Rule: unless there are "not normal circumstances," a new open heart surgery program will not be approved in a district if the approval would reduce the volume below 350 procedures annually at any existing OHS provider in the district. This is the intent and objective of the sentence despite the use of the word "an" to modify the term "existing adult open heart surgery program in the district" used toward the end of the sentence. As was testified by the Agency representative: [T]he entire notion of the rule, the entire intent of the rule is that existing providers maintain the 350 level. I mean, [there's] no question about that, so that has to be considered. (Tr. 3287). Indeed, intent that it is desirable for individual existing OHS providers to perform 350 procedures in 12-month periods is expressed elsewhere in the Rule. And that goal is so desirable, in fact, that new programs in a district are not under normal circumstances to be approved if the 350 level has not been met recently by an existing provider in the district: (7) Adult Open Heart Surgery Program Need Determination. (a) A new adult open heart surgery program shall not normally be approved in the district if any of the following conditions exist: * * * One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 3 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 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; . . . Rule 59C-1.033, F.A.C., (e.s.). Given the clear intent of the Rule as a whole and of the first sentence of subparagraph (7)(c), the formula in the challenged portion of the Rule (the "formula"), should be used to measure and determine whether the approval of a new OHS program would reduce the annual volume of OHS procedures at any existing OHS provider below 350. Under the formula, adult open heart surgeries are projected for each service district. The resulting number is divided by the number of existing OHS programs plus one new OHS program. If calculation results in a number less than 350, the third sentence of the subparagraph purports to carry out the intent of the first sentence of subparagraph (7)(c), that is, "no additional open heart surgery program shall normally be approved." For example, assume 3000 OHS are projected for a service district with five existing programs. Under the formula, 3000 would be divided by six (the existing five plus the proposed program). The result is 500, and the operation of the subparagraph does not prohibit a new OHS program. If, on the other hand, a volume for the district of 3000 were projected and there were eight existing providers, the addition of a ninth program would bring the average below 350 and, by operation of the third sentence, prohibit the approval of a new program. The challenged portion of the Rule, however, does not necessarily implement the objective of the first sentence of subparagraph (7)(c). The calculations in the challenged portion do not determine whether the volume at any specific provider would fall below 350 as the result of a new program. Instead, the calculations measure only the "average" volumes at existing programs plus one new one. A program operating slightly above 350 (such as CRMC), with the addition of a new program (such as the one proposed by Venice) in close enough proximity that their primary service areas significantly overlap, could drop below 350, even though the number of OHS procedures in the district is calculated district-wide to increase and even though the average calculated by the formula exceeds 350. Such a result increases in likelihood when one of the providers in the district (such as Memorial) is projected to have volume significantly above 350. Illustrations of the ineffectiveness of the challenged portion for achieving the clear objective set forth in the first sentence of subpararaph (7)(c) are in CRMC Exhibit no. 58. For example, in 1997, existing OHS providers in District 8 had an average volume of 716. That year CRMC performed only 369 OHS procedures. Had Venice commenced an OHS program in 1997, adverse impact analysis and service area overlap as used by Mr. Baehr in this proceeding show that CRMC would have dropped below 350 procedures in 1997, while the district average would have remained well above 350 despite the addition of a new program.
