The Issue Whether the Petitioner, Bethesda Memorial Hospital, Inc., (Bethesda) is entitled to a certificate of need (CON) in order to convert three general acute care beds for use as Level III neonatal intensive care unit (NICU) beds.
Findings Of Fact The Agency for Health Care Administration is the state agency charged with the responsibility of reviewing applications such as the one at issue in this proceeding. The parties have stipulated that whether or not the subject application should be approved must be decided upon a weighing and balancing of all pertinent statutory and rule criteria. Bethesda’s letter of intent and application for CON were timely filed in an appropriate batching cycle. Bethesda is a 362-bed acute care hospital located in Boynton Beach, Palm Beach County, Florida. As such, it is located within the Agency’s District 9. The approval of the CON at issue would allow Bethesda to convert three of its existing acute care beds to Level III NICU beds. This approval would expand Bethesda’s existing NICU from 12 beds, which are designated Level II NICU beds, to a total of 15 beds for the combined NICU. Bethesda received a CON for its existing NICU in 1985. From its inception, the unit has been staffed and equipped for the highest level of NICU care and, in fact, performed Level III care until 1995 when the Agency ordered it to stop admitting babies of less than 1000 grams in weight. At the time of the original approval of the Bethesda NICU, the Agency did not distinguish between Level II and Level III NICU beds. Nevertheless, Bethesda staffed and equipped its unit based upon the highest level of care because of the population it has historically served. Later, as the Agency developed more distinct guidelines between Level II and Level III NICU beds (as well as a statewide bed-need methodology), Bethesda found it could not technically continue to do what it had historically done, i.e., serve a Level III newborn. Bethesda has historically served these Level III newborns because it is under contract with the Palm Beach County Public Health Unit (PHU) to care for indigent mothers and at-risk babies. This agreement to serve indigent mothers and at-risk babies has resulted in a significant number of babies being delivered at Bethesda requiring neonatal intensive care at all levels. Until 1989, Bethesda was the only hospital to provide obstetrical care in the southern portion of Palm Beach County, much less make exceptional provision for indigent birth mothers. As it developed, Bethesda provided quality obstetrical, pediatric, and neonatology services in an area of Palm Beach County where other providers were less than enthusiastic about the market. Except for St. Mary’s Hospital in the northern portion of the county, no other provider has extended services to the indigent as demonstrated by Bethesda. Moreover, Bethesda has offered to condition its CON approval on the provision that it render a minimum of 35 percent of the facility’s entire NICU patient days, including Level II and Level III, to Medicaid/charity patients. Thus, a major emphasis of this application is care for the indigent. Of all patients cared for in the south Palm Beach County neonatal programs, ninety-nine percent are indigent. While a provider may receive reimbursement for certain services (from Medicaid or local health district funds), the patients themselves (birth mothers and babies) are indigent. Additionally, one-third of the pregnancies processed through the PHU are high-risk due to diabetes, infectious diseases, or other complications. As a logical consequence of the complications with the birth mother, the babies born through the PHU program tend to be sicker than average. While Palm Beach County has demonstrated a remarkable improvement in providing pre-natal care to birth mothers and thereby improving at-risk results, Bethesda continues to play a critical role in extending care to this needy population. Bethesda is the exclusive hospital used by the PHU in south Palm Beach County. It is utilized because it is geographically located near the patient population. Further, Bethesda’s reputation in this community makes it attractive to those in need. Bethesda is engaged in a three-way partnership with St. Mary's Hospital and the PHU to lower infant mortality in the county. They have created an integrated care plan for south Palm Beach County maternity patients. Bethesda, physicians in the community (including obstetricians, gynecologists, neonatologists and pediatricians), and the PHU have worked together for 11 years to make sure that protocols are available so that pre-natal care is available to all who need it. These parties work closely with Healthy Mothers/Healthy Babies and other voluntary organizations to bring patients to the PHU or to Bethesda. The PHU physicians and midwives deliver between 800 and 1,000 babies a year. About 25 percent of these babies from the southern portion of the county will require some kind of Level II or Level III NICU care during their stay in the hospital. Thus, 200 to 250 babies needing NICU care come through the PHU each year. It would also be expected that non-indigent mothers from the southern portion of the county would deliver babies requiring NICU care. Bethesda plans to open outlying health clinics to enhance services offered to local communities within the Bethesda zip codes. These programs or clinics are expected to result in an estimated 20 percent increase in the volume of indigent pregnant women served by Bethesda. The availability of services to the local communities may also assist patients to keep their scheduled appointments. There is a difference between the number of patients scheduled to see PHU physicians and those who actually show up, due to the inconvenience and financial burden of getting to the health unit. Having the clinic locations readily available may alleviate the inconveniences to the indigent mother. Under the present circumstances, when a Level III baby is delivered at Bethesda it must be transferred to another facility. These transfers create a major burden for the birth mother. Remembering that the mother would not typically be transferred with the child (and would not require the extended stay some neonates demand), the issue of transportation for the parent may be insurmountable. For example, in order to leave a convenient location to visit once or twice a day, an indigent mother must arrange transportation to and from the Level III facility where the baby has been sent. This may entail additional expenses for the parent such as lost wages or extending times for babysitters watching other children in the home. These additional expenses may be more than the indigent family can bear. The nearest Level III NICU provider to whom Bethesda now transfers patients is St. Mary’s Hospital. This facility is, by automobile, approximately 30-40 minutes from Bethesda depending on traffic conditions. Bus transportation directly connecting one site to the other, if it were available (which it is not), would presumably take longer. Currently, even when it is determined that a maternity patient should be sent to St. Mary's Hospital for pre-natal care, the mothers are presenting for delivery at Bethesda. This occurs because Bethesda is geographically located in the area where they live. The baby is born at Bethesda and a decision must be made how best to deal with the health issues of the child. Of the patients referred from Bethesda to St. Mary's Hospital for pre-natal care, only 5 percent deliver at St. Mary's. Ninety-five percent return to Bethesda for delivery even though they were told to go to St. Mary's. The main reason for this failure of patients to follow up at St. Mary's Hospital is the lack of affordable transportation. Many indigent women do not have cars or access to them. The existing facilities in Palm Beach County for Level III care are not reasonably available, appropriate, or accessible alternatives for these patients. AHCA District 9 has only three Level III NICU providers. They are all in Palm Beach County, with St. Mary's Hospital and Good Samaritan Hospital (now owned by the same company) in the northern part of the county (West Palm Beach) and West Boca in the southern part (Boca Raton). West Boca is not a reasonable alternative for the NICU patient population served by Bethesda. West Boca does not serve the lower income patients. In fact, West Boca transfers patients without financial resources to Bethesda. West Boca transfers indigent women in labor early enough so that COBRA regulations are met. Pertinent to this case, historically, West Boca transferred indigent Level III NICU patients to Bethesda until 1994. During the last three years, Level III NICU utilization at Good Samaritan and St. Mary's Hospital has averaged better than 90 percent. To average 90 percent means that the beds are often full or there are more patients than there are beds. Accordingly, these providers are operating at what is essentially capacity. It is, therefore, not surprising that St. Mary's Hospital supports Bethesda's CON application in this proceeding. No existing provider within District 9, including West Boca, formally opposed the instant application. A primary service area is the area from which a hospital draws the overwhelming majority of its patients for a given service and is defined by zip code level information. The primary service area of Bethesda for providing newborn and neonatal services is wholly within what has been described in this record as the southern portion of Palm Beach County. The primary service areas of West Boca and Bethesda for newborn and neonatal services do not significantly overlap. In fact, 40 percent to 45 percent of these services provided by West Boca have been to residents of Broward County. In this regard, West Boca's neonatal services compete more directly with those of Broward General Hospital than Bethesda. Bethesda's NICU is currently staffed and equipped for Level III services. From a medical standpoint, the CON proposal will result in a quality 15-bed dual unit, which is very efficient from the neonatologist's standpoint. The neonatologists staffing the Bethesda NICU are associated with the same group serving St. Mary's Hospital and Broward General Hospital, both Regional Perinatal Intensive Care Centers (RPICC). This helps assure proficiency with large volumes at more than one program. The nursing staff at Bethesda all have at least two years of Level III experience, and no nurse is currently hired for the NICU without that level of experience. From a neonatal nursing care standpoint, the addition of the three Level III beds would result in quality, cost- efficient care. The proposed combined unit would allow for flexibility of making daily staff assignments and would enhance care for the babies. The combined 15-bed NICU is large enough to provide quality, cost-effective Level II and III care. Bethesda has the physician staffing, nurse and therapist staffing, equipment, facilities, and hospital services to provide proper quality tertiary care for these newborns. Since 1993, Mease Hospital in Dunedin, Florida, has operated a five-bed Level III NICU combined with a five-bed Level II NICU in one room. It has proven to be a quality program with a low mortality rate. The five-bed Level III NICU provides cost- efficient care. There is no reason Bethesda cannot duplicate the record Mease has demonstrated. High quality, neonatal intensive care may be easier to achieve with Level II and III beds in the same room than with any other configuration of beds. Bethesda will not be able to treat every sick baby. It cannot care for babies requiring open heart surgery (Bethesda does not have an open heart surgery program), for those needing extra-corporeal membrane oxygenation (ECMO), nor those seeking pediatric cardiac catheterization. None of the three existing Level III facilities in District 9, however, has open heart surgery or ECMO available. Like Bethesda they, too, must transfer out for these services. Fortunately, the Agency rule allows a provider to make written arrangements with other Level III providers to provide those services in the same or nearest service area. AHCA has stipulated that Bethesda has the appropriate written transfer agreements pursuant to Rule 59C-1.042(12), Florida Administrative Code. For the number of babies to be served by Bethesda, the ability to serve Level III babies will improve the quality of care. There are medical risks in transferring babies from one facility to another. When adequate staffing and facilities are available at the hospital of birth, transferring the infant to another provider may pose an unnecessary risk. The risks inherent in transfers do not always outweigh the benefit. For example, transferring the child may delay certain treatments such as use of "surfactants" which protect a baby's lungs. Other risks such as those associated with maintaining the infant's blood pressure or body temperature make transfers difficult and, in some instances, medically questionable. Bethesda’s application for the instant CON meets the applicable local and state health plans. Bethesda has an established record of providing quality care and will be well able to provide quality of care for the services allowed by the proposed addition of three Level III NICU beds. It is unrealistic for Bethesda to refuse admission to patients requiring Level III NICU services given the historical and current patterns of births for this District. Bethesda’s proposed addition of three Level III beds to its NICU is financially feasible both in the short- and long- term. Bethesda’s Level III NICU beds will be programmatically accessible to its patient population. Although 90 percent of the District 9 population is within two hours ground travel time of an existing Level III NICU bed, such accessibility does not consider the unique characteristics of the indigent population the proposed beds at Bethesda will serve. Moreover, the provider who would otherwise serve the Level III patient under such scenario supports this application. The existing facilities providing care to the indigent population operate at capacity and are fully utilized. The only facility not fully utilized (West Boca) has no significant history of providing care to the Medicaid/indigent population. The proposed construction or renovation of the Bethesda unit to accommodate fifteen NICU stations is reasonable. While Bethesda will have to meet certain minimum licensing standards in the configuration of the NICU, it is anticipated that such standards will be met with little difficulty or significant expense to Bethesda. The unchallenged fixed-need pool for the batching cycle applicable to this case was one Level III bed. Bethesda has met all Agency requirements regarding “Emergency Transportation,” “Transfer Agreements,” and “Data Reporting Requirements.” The Agency’s rule regarding minimum unit size for a Level III NICU has not been met. However, this requirement has not been adhered to by the Agency in several instances. In AHCA District 9, there are three hospitals with NICU Level III programs. Not one of these programs has 15 beds. St. Mary's Hospital (a RPICC) has ten beds, Good Samaritan has eight beds, and West Boca has five beds. The quality of care at these providers is presumably adequate despite the fact that they were approved and licensed by the Agency with less than fifteen beds. Moreover, the Agency has never considered the 15-bed minimum an absolute bar to the application for, or the review of, lesser-numbered beds. In fact, the Agency approved new Level III NICU beds at Mease Hospital (a five-bed unit), West Boca Hospital (a five-bed unit), and Miami Baptist Hospital (a seven-bed unit) after the rule was promulgated. Additionally, the total number of all NICU beds at Mease and West Boca is less than fifteen. Thus, as stipulated in South Miami Hospital, Inc. v. Agency for Health Care Administration, Case No. 97-04875, currently pending before the First District Court of Appeal, the Agency has “consistently interpreted those unit size rule provisions as permissive.” Bethesda has presented not normal circumstances supporting this CON application which are hereby accepted. Such circumstances include: accessibility issues for indigent or Medicaid mothers and babies; the lack of Level III beds in the southern portion of the county where 60 percent of all resident live births are delivered; the fact that approximately one-third of the low birth weight mothers reside in the service area for Bethesda yet the majority of the Level III beds are in the northern portion of the county; and the fact that 30 percent of Bethesda’s patients are clients from the PHU. The average occupancy rate for Level III NICU beds for the year applicable to this application was 80.9 percent. As a result, the rule mandated minimum average occupancy rate has been met.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED That the Agency for Health Care Administration enter a final order approving CON application Number 8235 with the condition that Bethesda provide indigent/Medicaid care as proposed in the application. DONE AND ENTERED this 24th day of February, 1998, in Tallahassee, Leon County, Florida. J. D. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 24th day of February, 1998. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308-5403 Paul J. Martin, General Counsel Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3431 Tallahassee, Florida 32308-5403 Richard A. Patterson, Esquire Agency for Health Care Administration Fort Knox Building 3 2727 Mahan Drive, Suite 3407B Tallahassee, Florida 32308-5403 Kenneth F. Hoffman, Esquire M. Christopher Bryant, Esquire Oertel, Hoffman, Fernandez & Cole, P.A. Post Office Box 6507 Tallahassee, Florida 32314-6507
Findings Of Fact Petitioner, OMCO, is a corporation formed by Basic American Medical, Inc.(BAMI), to apply for a certificate of need (CON) to construct and operate a 120-bed acute care osteopathic hospital in Ocala, Florida. Petitioner is incorporated with 1,000 authorized shares with a par value of $1.00 per share. All shares of OMCO are controlled by BAMI pending issue. To obtain local support for the application, BAMI has offered local investors, principally doctors, the opportunity to purchase ten shares each at par value conditioned upon the issuance of a CON to OMCO. Up to 20 percent of the stock is proposed to be issued to 20 such investors (Exhibit 3). At the time of the hearing 10 percent of the stock had been issued to ten doctors, each of whom paid BAMI $10.00. Financing of the project is to be arranged by BAMI and, although BAMI is prepared to provide in excess of $1 million for initial construction and $1 million for start-up operating expenses, the entire cost of the project is intended to be funded with long-term financing. Arrangements for this financing is to be handled by Century Mortgage Corp., a wholly owned subsidiary of BAMI. Century Mortgage Corp. offered to provide $9 million at 12.5 percent for 25 years and $3.6 million at 13.5 percent for 8 years, for equipment, but proposes to serve only as a broker between OMCO and the investors who advance the money. BAMI corporate officers testified that Marion County was selected as the site for the proposed hospital because the state acute care bed methodology rule indicates there is a need for additional acute care beds in Marion County. No need for osteopathic hospital beds was determined but the application was submitted for an osteopathic hospital because, under Florida law, it was believed easier to get a CON for an osteopathic hospital than for an allopathic hospital. One of these investors, Sheldon Katanick, D.O., is a resident of Michigan who is contemplating a move to the Ocala area. Dr. Katanick is a radiologist but is currently on the staff at no hospital. He would prefer to practice at an osteopathic hospital rather than at an allopathic hospital because "There are procedures I might want that wouldn't be carried out at an allopathic hospital." No further identification of these procedures was given. As a radiologist Dr. Katanick would admit fewer patients than he would if he were in general practice. He estimates that he would admit five to ten patients per month if the application is approved and he moves to Ocala and establishes a practice. Arthur Paraiso, M.D., lives in Bellview, some ten miles south of Ocala, and is also an investor in OMCO. He has never served on the staff of an osteopathic hospital but would have no objection to serving on such a staff and will serve if the hospital is built. Paraiso is currently on the staff of no hospital. He recently resigned from the staff of Munroe Regional Medical Center because he "didn't like the atmosphere." He was told to resign from the staff of another hospital which was not identified. He has approximately 1,000 active patients but has no idea how many of these patients he would admit to the proposed hospital. Ronald E. Shelley, D.O., has operated the Bellview Medical Center for 16 years as sole practitioner. Although he has served on the staff of allopathic hospitals in the past, he is currently on the staff of no hospital. He considers the commuting from Bellview to Ocala (ten miles) to be difficult and prefers to refer his patients needing hospitalization to a doctor admitted to the staff at one of the Ocala hospitals. Also, he considers it difficult for a sole practitioner to serve on the staff of a hospital without being covered by another practitioner in his office. Shelley sees up to 60 patients per day in the winter season and approximately 40 patients per day during the summer. Most of the patients he has hospitalized go to an Ocala hospital but occasionally he sends patients to an osteopathic hospital in Orlando. Dr. Shelley is also a stockholder in OMCO and is on the board of directors. He is president of District Twelve Osteopathy Group, which has 25 members located throughout District Three, the health planning district in which Marion County is located. Robert M. Corbett, D.O., supports the application to construct an osteophathic hospital at Ocala. He operates two emergency walk-in clinics, one at Crystal River, Florida, and one at Ocala, Florida. He holds staff privileges at Seven Rivers Community Hospital in Crystal River and consulting privileges at Marion Community Hospital, which authorizes him to admit a limited number of patients to this hospital each year. Emergency clinics are staffed with four DO's and two MD's. Generally, the clinics treat emergency patients, and if one of these patients needs to be hospitalized the clinic refers the patient to a doctor on the staff of the appropriate hospital for admission. Dr. Corbett and the other doctors manning the emergency walk-in clinics do not have time to run the clinics and monitor patients in the hospital at the same time; hence, the referrals to another doctor for admission. Dr. Corbett did not testify he would change his mode of operation of referring patients for hospitalization and personally admit patients if an osteophathic hospital opened in Ocala. Robert Panzer, D.O., testified by deposition submitted after the final hearing date. Dr. Panzer has been practicing osteopathy in the Ocala area for approximately eight years and has about 5,000 active patients, of which six to ten are normally hospitalized. He admits all of his patients through M.D. specialists. He applied for and was accepted on the staff of Munroe Regional Medical Center, but never exercised the privileges granted. Panzer testified that he was told by a staff member at an Ocala hospital that he could not do manipulation of patients in the hospital; but, on cross-examination, he could not recall who told him that.; Dr. Panzer also has patients from outside Marion County. If this osteophathic hospital is authorized, Fanzer would join the staff and admit patients. He is one of the ten local investors and has been elected to the board of directors of the proposed hospital by the other investors. Other than the testimony of Dr. Panzer that he could not practice manipulation at a local hospital, no testimony was presented that any osteopathic patient is unable to obtain adequate treatment at existing facilities in Marion County, that existing hospitals refuse to admit osteopathic physicians to their staffs, or that there is any unmet need for osteophathic treatment in Marion County. There is no osteopathic hospital in District Three, which includes Marion County and 15 other surrounding counties. In District Three there are approximately 25 osteopathic physicians; in Marion County there are eight, of which only two, including Panzer, have applied for staff privileges at a Marion County hospital. Considerable testimony was presented that once an osteopathic hospital is built additional osteopathic physicians will move to the area, will build up practices, and utilize the facilities provided. Only general historical data from other counties was presented to support this position. In those counties cited the population is more urban than is Marion County and District Three population. Except for one hospital in Palm Beach County, osteopathic hospitals in Florida have a lower occupancy rate than do allopathic hospitals. Most DO witnesses emphasize the holistic approach to the patient taken by the osteophathic physician in his treatment as compared to the treatment of the specific illness used by an allopathic physician and to the fact that greater use of manipulative therapy is used in the practice of osteopathic medicine than in the practice of allopathic medicine. Otherwise, all witnesses generally agreed that the physical facilities provided at an acute care hospital are identical at allopathic and osteopathic hospitals. A bed in an allopathic hospital is indistinguishable from a bed in an osteopathic hospital and the primary difference between the two practices results from the philosophical approach to medicine each takes. As a result, patients of osteopathic physicians receive more physical therapy treatment than do patients of allopathic physicians albeit by use of identical equipment. Plans and cost estimates for the proposed hospital, including equipment, are taken largely from an allopathic hospital recently opened by BAMI at Kissimmee, Florida. The implementation of the Diagnostic Related Groups (DRG's) by the Federal Government for Medicare patients and greater emphasis and growth of Health Maintenance Organizations (HMO's) and Preferred provider Organizations (PPO's) which have occurred during the past year have coincided with a major reduction in the usage rate of hospital beds in the subdistrict of Marion County as well as throughout the State of Florida and the United States. For reasons generally attributed to actions intended to reduce the cost of medical treatment, patient days and hospital occupancy rates have been materially reduced and if current trends continue substantial rate increases will be needed to keep many hospitals solvent. This factor is affecting the existing 15 osteopathic hospitals in Florida at the same or greater rate than it is affecting the allopathic hospitals. Although Gulf Coast Hospital v. DHRS, 420 So.2d 86 (Fla. 1st DCA 1982), indicates the acute care bed need rule, 10 5.11(23), F.A.C., is not applicable to determining need for osteopathic hospital beds, Petitioner uses this rule to show a need for acute care beds exists in Marion County. Because the acute care bed rule is partly based on a 1978 statewide use rate to determine need, the methodology overstates the need for new beds. Since 1978 the use rate has decreased throughout the state but the rule has not been modified to reflect this reduction in use rate. District Three, the 16-county area including Marion County, has a need for acute care beds in 1990 (the target year for this application) of 191. Using the 1984 use rate, Marion County will have a need for 87 acute care beds in 1990. The Health Planning council for District Three has recommended that 15 percent of the district bed need should be set aside for Levy, Dixie, and Gilchrist Counties, which have been determined to be underserved. This reduces the potential allocation of beds to Marion County to 74. As a general rule CON's for less than 100 bed hospitals are not granted because those hospitals tend to be less cost-effective than are larger hospitals offering the same services. Absent a bed need methodology for osteopathic hospitals, DHRS developed two methodologies to determine need for osteopathic hospital beds. The first methodology divides the number of admissions to osteopathic hospitals in each county in 1984 by the number of doctors of osteopathy in the county to arrive at an admission rate per DO. This is multiplied by the average length of stay (ALOS) to arrive at the number of patient days per DO. Averaging the patient days per 1,000 population for these osteopathic hospitals in the southern Florida counties in which osteopathic hospitals are located gives an average of 63.3 patient days per 1,000 population in these counties. Applying this figure to the population of Marion County in 1990, the five year planning horizon used to determine the hospital bed need, shows approximately 41 osteopathic beds will be needed in Marion County in 1990 (Exhibit 9). The second approach which is not really a bed need methodology as much as a check on the requested beds is to determine from the same historical data the number of DO's needed to support a 120-bed hospital. That figure is calculated to be 91 (Exhibit 9). Methodologies proposed by OMCO's expert witnesses rely heavily on the acute care bed need methodology established by Rule 10-5.11(23), F.A.C. although the courts have held that this methodology is not applicable to osteopathic hospitals because of the language of Section 381.494(2), Florida Statutes, which requires "The need for such facilities shall be determined on the basis of the need for and the availability of osteopathic services and facilities in the community." Further, Petitioner attempts to justify the need for an osteopathic facility in District Three, which has no osteopathic hospital, on the basis of the population of the district as a whole despite the long distances involved in this 16-county area. Obviously, people in the extreme northwestern part of this district are unlikely to use the proposed facility in Ocala in view of much nearer acute care hospital beds. Only a hospital offering those services provided by a regional medical center can expect to have a districtwide service area. Here, OMCO proposes to provide only basic acute care facilities and few patients could be expected from beyond the primary service area of Marion County. With the current decline in hospital occupancy rate, the introduction of a new hospital in Marion County will have an adverse impact on existing hospitals since patients that would be admitted at OMCO would generally come from those patients that otherwise would use MCH or MRMC. This would serve to reduce even further those hospital occupancy rates and adversely affect the ability of MRMC to serve indigent patients. Because of the declining occupancy rates in all hospitals and the generally lower occupancy rates at osteopathic hospitals in Florida, the financial feasibility of the project is questionable despite OMCO's witnesses who attested to the financial feasibility of the project. The estimates on which these opinions of financial feasibility are based are not realistic and do not incorporate the latest data on occupancy rates for the calendar year 1984 which were available, albeit not in final published form, at the time of the hearing. Evidence presented for those completed months of 1985 indicates the occupancy rates are further declining in the Marion County hospitals in 1985. OMCO proposes to serve as a teaching hospital and presented witnesses who so testified. Before a hospital can serve as a teaching hospital, it must meet certain qualifications, such as having as heads of all departments DO's who meet specific requirements, and thereafter be certified as a teaching hospital by the American Osteopathic Association. While it is certainly possible for OMCO to meet these requirements and be so certified, it is speculative to say at the present time that such certification will be obtained. Evidence of need for additional teaching hospitals was submitted only by objected-to hearsay testimony not corroborated by admissible evidence. Accordingly, need for additional osteopathic teaching hospitals was not shown. None of the other criteria of Section 381.494(6)(c)1 13, Florida Statutes, are of sufficient comport to justify denial of this application if a need for the proposed facility had been demonstrated. Absent a showing of need, further discussion of these criteria is not deemed warranted or necessary to the findings.
The Issue The issue for resolution is whether proposed amendments to Rule 10- 5.042(14)(a) and (f), F.A.C. constitute an invalid exercise of delegated legislative authority, as asserted by petitioner.
Findings Of Fact In 1987, the department began to develop a rule to govern certificates of need ("CON") for Level II and Level III neonatal intensive care services in hospitals (hereinafter referred to as "NICU"). That process ultimately led to the department's publication of Proposed Rule 10-5.011(1)(v), F.A.C. (now renumbered as Rule 10-5.042, F.A.C.) on November 3, 1989. (Joint Prehearing Stip., p.4). All pertinent provisions of the NICU Rule were upheld in a final order issued by DOAH in June, 1990, and affirmed by the District Court of Appeal, First District, in St. Mary's Hospital, Inc. v. Department of Health and Rehabilitative Services, 12 FALR 2727 (DOAH, June 12, 1990, aff'd, Baptist Hospital v. Department of Health and Rehabilitative Services, 578 So.2d 1004 (Fla. 1st DCA 1991). (Joint Prehearing Stip. p. 4). The NICU Rule became effective on August 6, 1990. (Joint Prehearing stip., p. 4). Paragraph 14 of the NICU Rule addresses the entitlement of hospitals to implement, or to continue to operate Level II or Level III NICU services. Paragraph 15 prescribes the process for creating an inventory of those hospitals authorized under the NICU Rule to provide Level II or Level III NICU services. Paragraph 15 provides that the department publish a preliminary inventory of those hospitals it has determined meet the entitlement criteria contained in Paragraph 14. It provides further that hospitals be allowed to contest the preliminary inventory. (Rule 10-5.042, F.A.C.). The department published a revised preliminary inventory on September 21, 990, in the Florida Administrative Weekly, authorizing Winter Haven to operate an 11 bed Level II NICU Unit. (Joint Prehearing Stip., p.4). Winter Haven was included in the inventory based on its documentation that the agency had approved construction plans for creation of NICU beds in an expansion project. On August 6, 1991, Hearing Officer Veronica Donnelly issued a recommended order in Lakeland Regional Medical Center, Inc. v. Department of Health and Rehabilitative Services, DOAH Case Nos. 90-7682 and 90-7683, regarding Lakeland's challenge to Winter Haven's inclusion in the preliminary inventory. Among other things, the Hearing Officer recommended that the department enter a final order excluding Winter Haven from the inventory of facilities authorized to provide Level II NICU services. (Joint Prehearing Stip., p.4). The Hearing Officer's recommended order concluded Winter Haven had not demonstrated that it complied with the grandfathering provisions of subparagraph 14 of the NICU Rule. It further concluded that DHRS lacked the authority to adopt a policy which conflicted with the plain meaning of the NICU Rule. On September 23, 1991, the department issued its final order. (Joint Prehearing Stip. p.5). DHRS' final order concurred with the Hearing Officer's recommendation that Winter Haven was not entitled to be included in the inventory of Level II NICU beds pursuant to the criteria contained in the NICU Rule. Nonetheless, the final order held that the department was estopped from excluding Winter Haven from the inventory on the theory of equitable estoppel, and, therefore, ordered that the final inventory include 11 Level II NICU beds at Winter Haven. The final order found that Winter Haven relied on representations by the department over a five-year period to establish its Level II NICU unit, hire employees and commence operation. (Lakeland composite exhibit #2). On October 14, 1991, Lakeland filed a notice of appeal appealing the portion of the final order requiring that the final inventory include 11 Level II NICU beds at Winter Haven. (Joint Prehearing Stip., p. 5). As a result of the Hearing Officer's recommended order, the department initiated the current rulemaking proceedings which culminated on December 27, 1991, when DHRS published the first version of the proposed amendments to Rule 10-5.042(14)(a) and (f) in Volume 17, No. 52, Florida Administrative Weekly. On March 13, 1992, however, the department withdrew those proposed rule amendments. (Joint Prehearing Stip., p. 5). On March 13, 1992, DHRS published a second version of the proposed amendments to Rule 10-5.042(14)(a) and (f) in Volume 18, No. 11, Florida Administrative Weekly, which were substantially identical to the first version. On May 29, 1992, the department withdrew the second version of the proposed rule amendments. (Joint Prehearing Stip., p. 5). On May 29, 1992, DHRS published a third version of the proposed amendments to Rule 10-5.042(14)(a) and (f) in Volume 18, No. 22, Florida Administrative Weekly, which were substantially identical to the first and second versions of the proposed amendments, and which are the subject of Lakeland's challenge in this proceeding. (Joint Prehearing Stip., pp. 5-6). At the time the department proposed the rule amendments that are at issue in this proceeding, there were only three providers of which the department was aware, i.e., Alachua General Hospital, Winter Park Hospital, and Winter Haven, who had construction plans deemed approved by the department allegedly authorizing neonatal intensive care beds prior to October 1, 1987. (Joint Prehearing Stip., p. 6). Alachua General Hospital and Winter Park Hospital were included in the preliminary inventory of Level II NICU beds. Their inclusion in the inventory was either not challenged, or was challenged and subsequently dismissed. Alachua General Hospital and Winter Park Hospital were also included in the final inventory of Level II NICU beds. Their entitlement to be included in the final inventory is final and is not subject to further appeal. The department is not currently aware of any other providers, who have construction documents approved by the department prior to October 1, 1987, as a basis for being included in the inventory under the proposed amendments. (Joint Prehearing Stip., p. 6). Elfie Stamm is responsible for rule development, special studies, and the development of fixed need pools at the department. Ms. Stamm was responsible for the development of the NICU Rule and the proposed amendments. She also was responsible for evaluating the information submitted to the department by providers seeking to be included in the inventory of the NICU beds under the NICU Rule. 19 . The proposed amendments merely authorize one additional basis for "grandfathering in" neonatal intensive care services at hospitals. (Ex. 1; Proposed Amendments, Florida Administrative Weekly, Volume 18, No. 22, May 29, 1992, pp. 3061-3062). The amendment is intended to allow the agency, under specified conditions, to acknowledge a type of prior departmental authorization for neonatal intensive care services which is not specified in the current rule. The proposed amendments represent the agency's current policy adopted in October of 1990, or within about two months of the effective date of the NICU rule. Knowledge about the problem first came to light within two months of the August 1990 effective date of the new NICU rule when Alachua General Hospital sought grandfathering under the new rules because of its approved construction documents. The agency believed that the construction plans that it had approved for Alachua General came under its rule. The department considered it consistent with the grandfathering provision for hospitals which had indicated on their licensure application that they provide the services. Also soon coming forward for grandfathering because of approved construction documents were Baptist Hospital in Pensacola, Winter Park Hospital in Orlando, and Winter Haven Hospital in Winter Haven, Florida. Alachua General and Winter Park were considered grandfathered. Because Baptist had not produced sufficient evidence that it had approved construction documents, it was denied. If Baptist can prove it had approved construction documents it might later be grandfathered. When the department promulgated the existing rule, had it been aware of the issue involving documents approved for NICU construction, it would have specifically written into the rule the provision it is now promulgating. The already existing grandfathering provision includes facilities and providers which had not received anything from the agency in the way of approval, including those which had not received a CON, and had no recorded NICU services on their license application. The current rule includes hospitals which had no contact with the department, no approvals, no construction plans, and no licensure application. If grandfathering a provider which established the service without any approvals of any kind is appropriate, and is now part of the rule, the department considers it should approve a hospital which affirmatively obtained approval construction documents for this service. Such facilities have proceeded in good faith, approved by the same agency that issues certificates of need, so the department believes that they should be authorized to provide the service. The department's Office of Plans and Construction had by 1987 specific construction standards for Level II and Level III NICU beds and still does. The Office of Plans and Construction in the past approved specific levels of care for NICU. In 1987 there were published standards for plans and construction that covered Level II and III neonatal care beds. The department, in its preparation of this amendment, did not analyze all factors listed under Section 381.704(3), F.S., because that statute refers to the development of need methodologies and the subject amendments are not a need methodology. They are used to establish an inventory of existing beds which inventory is a factor in the need methodology. NICU services are tertiary health care services, services which are intensive and complex, and generally present a certain degree of risk in the delivery of the service. As a result, tertiary health care services are regionalized. NICU services, therefore, are not necessarily available in every hospital which provides obstetrical services to its patients. There was no competent evidence that the proposed rule amendments will cause disruption in services. Those grandfathered in under this policy are already on inventories and in operation, including Winter Haven. Ms. Stamm testified she could not conclude from existing evidence that disruption would occur, and to the contrary, increased competition might be a result, along with the potential for improvement in service. Based on department experience, it is not likely that any hospitals remain with approved construction plans from prior to October, 1987, which would be able to come forward now to seek approval, although as found above, it remains possible. Any grandfathered facility (under the proposed amendments) must meet all licensure requirements for NICU beds, and must meet all requirements of the NICU rule within one year (Rule 10-5.042(14)(i), F.A.C.;). Medical quality is protected under licensure rules.
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant facts are found: Based upon an agreement between the petitioner and the respondent, and a later addendum, petitioner received Certificate of Need Number 1460 in February of 1981 granting the petitioner the authority to construct 126 additional general medical/surgical beds but to only license and operate 72 of such beds. The instant proceeding involves petitioner's application for a Certificate of Need to license and operate the remaining 54 beds which have been previously constructed under Certificate of Need Number 1460. St. Joseph's Hospital is a 649-bed full service major referral hospital in Hillsborough County owned and operated by the Franciscan Sisters of Allegheny. Its services include a comprehensive community mental health center, a comprehensive pediatric unit with 88 beds, a radiation therapy center, a 60- bed community cancer center, cardiac catheterization, cardiac surgery and a large and active emergency room. It serves a considerable number of indigent patients and participates in the Medicaid and Medicare programs. Petitioner is now requesting permission to license the regaining 54 beds which were authorized to be constructed pursuant to Certificate of Need Number 1460. The project involves no additional construction or renovation inasmuch as all 126 beds previously authorized have been completed. No capital expenditure will be required in order to place the 54 beds into operation. If the Certificate of Need is granted, petitioner intends to create two specialty medical/surgical units: a 32-bed cardiac surgical unit to accommodate patients from the open heart surgical program and a 22-bed medical unit for psychiatric patients requiring medical treatment. There currently are no other beds available in the hospital to convert for use for the psychiatric patient or for the cardiac surgical unit. Petitioner has been operating, on occasion, at occupancy levels in excess of 90 percent. At times, it has been necessary to place non-emergency patients in the emergency room and have them remain there until beds become available. There are sometimes up to 40 patients on the waiting list for elective surgery. Due to the shortage of empty beds, petitioner cannot now admit new members to its medical staff. Steady operation of the hospital at occupancy levels exceeding 90 percent can have an adverse effect upon the efficiency of the nursing staff and the quality of care offered to patients. Because the bulk of projected growth in Hillsborough County is expected to occur in the center and northwestern area of the county, it is anticipated that the pattern of utilization of petitioner's facility will continue. While the licensing of the 54 additional beds involves no capital expenditure on petitioner's part, it is estimated that, if petitioner is not permitted to license these beds, a total yearly loss of over $3.8 million will be experienced. This figure is the sum of lost net revenues from the beds in the amount of $87,339 and lost net ancillary revenues in the amount of $2.36 million, as well as the absorption of $232,750 in yearly depreciation costs and $1.14 million in committed indirect costs. Petitioner anticipates a loss per patient day, calculated at 100 percent occupancy, of $16.82 if the licensing of the beds is not approved. This would result in an increase of current patient charges by 9.1 percent in order to maintain petitioner's budgeted profit margin. Petitioner is located in HRS District VI which, at the time of the hearing, was composed of Hillsborough and Manatee Counties. Some 81 percent of all beds in the District are located in Hillsborough County. As of the time of the hearing, the District had 3,899 licensed acute care beds, with 606 additional beds having been approved but not yet operational. The generally accepted optimum utilization rate for acute care beds is 80 to 85 percent. For District VI, the overall utilization rate is below the optimum level. In Manatee County, utilization of acute care beds is at 78.3 percent. In Hillsborough County, the utilization level is at 77.4 percent, with the major referral hospitals experiencing a higher level of utilization than the smaller community hospitals. Rule 10-5.11(23), Florida Administrative Code, contains the governing methodology for determining acute care bed needs of the various Districts. Applications for new or additional acute care hospital beds in a District will not normally be approved if approval would cause the number of beds in that District to exceed the number of beds calculated to be needed. Application of the Rule's formula to District VI results in a total acute care bed need of 3,622 projected for the year 1988. Given the 4,505 existing and approved beds in the District, there are 883 excess beds in District VI under the Rule's formula methodology for projecting need. The 1982 Health Systems Plan adopted by the Florida Gulf Health Systems Agency makes no bed need projections for other specialty medical/surgical beds," but shows no need for medical/surgical beds. Rule 10-5.11(23), Florida Administrative Code, provides that other criteria may result in a demonstration of bed need even when the formula approach illustrates no need for beds. When additional beds are approved pursuant to other criteria, those beds are counted in the inventory of existing and approved beds in the area when applying the bed need formula to review future projects. The formula methodology does account for the inflow and outflow of patients in a specific area. While Rule 10-5.11(23) permits the Local Health Councils to adopt subdistrict bed allocations by type of service, the Council for District VI had not adopted its local health plan as of the date of the hearing in this matter. The Rule itself simply addresses the need for general acute care bed needs in the future.
Recommendation Based upon the findings of fact and conclusions of law recited herein, it is RECOMMENDED that the application of St. Joseph's Hospital, Inc. for a Certificate of Need to license 54 acute care medical/surgical beds be DENIED. Respectfully submitted and entered this 10th day of November, 1983, in Tallahassee, Florida. DIANE D. TREMOR, 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 10th day of November, 1983. COPIES FURNISHED: Ivan Wood, Esquire David Pingree Wood, Lucksinger & Epstein Secretary One Houston Center Department of Health and Suite 1600 Rehabilitative Services Houston, Texas 77010 1323 Winewood Boulevard Tallahassee, Florida 32301 Steven W. Huss, Esquire 1323 Winewood Boulevard, Suite 406 Tallahassee, Florida 32301
The Issue The issue is whether the Petitioner, Wellington Regional Medical Center, Inc., meets the criteria for approval of CON application number 9253 to convert 16 substance abuse beds to a seven-bed or ten-bed Level II neonatal intensive care unit.
Findings Of Fact The Agency for Health Care Administration (AHCA) administers the certificate of need (CON) program for health care facilities and services in the state of Florida. Wellington Regional Medical Center, Inc. (Wellington or WRMC) is a 120-bed community-based hospital, with 104 acute care and 16 substance beds. In September 1999, Wellington applied for CON Number 9253 to convert the 16 substance abuse beds into a ten-bed Level II neonatal intensive care unit (NICU). Currently, Wellington transfers newborns requiring Level II care to St. Mary's Hospital, in West Palm Beach, approximately 45 minutes away. The St. Mary's transport team can arrive as quickly as 20 to 30 minutes, but has taken up to four hours to pick up the babies. AHCA reviewed and denied Wellington's application, based on an absence of need in District 9 under criteria applicable to both normal and not normal circumstances, and the absence of any demonstrated problems for patients in getting access to Level II NICU care. For the January 2002 planning horizon used for applications which were, like Wellington's, filed in September 1999, AHCA published a numerical need for zero additional Level II NICU beds in AHCA District 9. The methodology used by AHCA to calculate numeric need, factoring in the existing inventory of 70 licensed and 20 approved beds, and applying the objective for 80 percent district-wide occupancy, resulted in a numeric need for a negative 32 beds. In other words, in District 9, there is a surplus of 32 Level II NICU beds, based on the formula established in AHCA's rules. The NICU II occupancy rate for 1998 was approximately 66 percent in District 9. In the absence of numerical need, Wellington applied for CON approval based on not normal circumstances, and contends it met, on balance, the requirements of the applicable criteria. 59C-1.042(6) - birth volume In Rule 59C-1.042(6), Florida Administrative Code, a not normal circumstance based on minimum birth volume is set forth, in pertinent part, as follows: Hospitals applying for Level II neonatal intensive care services shall not normally be approved unless the hospital had a minimum service volume of 1,000 live births for the most recent 12-month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. For this application cycle, the fixed need pool was published in July 1999; therefore, calendar year 1998 is the time period for determining birth volume. In 1998, there were 909 live births at Wellington. In 1999, live births at Wellington increased to 1,101, and, in the 12 months prior to the hearing, to 1,152. AHCA permits applicants to use the most recent data in cases involving not normal circumstances. Currently, approximately 100 live births a month occur at Wellington, which justifies the projection of 1,238 total live births for the year 2000. The current level of live births achieved at Wellington, over 1,000, is equaled or exceeded at fewer than 70 of over 200 hospitals in Florida. For the period ending June 30, 1999, 53 of the 70 hospitals also exceeded 1,200 live births. Of the 53 hospitals with over 1,200 live births annually, 48 had Level II NICUs. Six hospitals in Florida range between 1,200 and 1,499 live births a year; five have Level II NICU. 59C-1.042(5) - minimum ten-bed unit size AHCA's CON reviewer testified that she believed that AHCA had only deviated from the ten-bed minimum unit once, for CON Number 9243 to North Collier Hospital, a Medicaid disproportionate share hospital with over 2,000 live births. She also testified that, even though the applicant showed the required occupancy level in fewer than ten beds, CON approval for a ten-bed unit was awarded to Boca Raton Community Hospital (Boca Raton), in part, based on its large number of live births. By contrast, according to the chart on page 19 in AHCA's Exhibit 2, four of the seven Level II NICU providers in District 9 operated fewer than 10 beds at the time Wellington's application was approved. Apparently, unlike in the case of the Boca Raton application, AHCA held Wellington to the requirement of showing that it could reach 80 percent occupancy in the beds, although AHCA's expert health planner testified that the standard was a "benchmark," not an absolute bar to approval. In general, 1.1 Level II NICU patient days result from each live birth. The ratio of 1.1 to 1, when applied to 80 percent occupancy in a ten-bed unit, results in a mathematical necessity for 2,920 patient days a year, or a project volume of at least 2,654 live births a year. The use of the 80 percent district-wide occupancy standard for normal circumstances as a facility-specific standard for not normal circumstances is unreasonable and conflicts with the minimum volume requirement of 1,000 live births in Rule 59C-1.042(6). AHCA's application of the 80 percent occupancy requirement to Wellington is inappropriate and inconsistent with the agency's prior action. For example, in this case, arguably the failure to meet the normal standard for district occupancy might justify requiring a higher than normal facility standard, but AHCA has not done so with any apparent consistency. Only four out of 57 Level II providers in Florida exceed 2,654, the number of live births necessary to achieve the equivalent of 80 percent occupancy in a ten-bed NICU, three of those exceed 3,000 live births a year, and the fourth is in the range between 2,500 to 2,999 live births a year. Applying the 80 percent test with a 1.1 to 1 ratio to project Level II patient days, the six most recently approved Level II NICU applicants fall short, with projected occupancies ranging from 30 to 40 percent. 59C-1.042(8) - quality of care staffing standards Wellington provides obstetrical services in its Department of Maternal Health, also called the Center for Family Beginnings. Seven dedicated beds are used for labor, delivery, recovery, and postpartum care in that Department, with the frequent need to use overflow beds. Despite the screening of mothers prior to delivery to eliminate those whose babies are likely to need Level II or higher care, at least 25 percent of all expected normal deliveries develop into high risk problems. Wellington is already equipped to handle these unexpected, high risk babies, as it must do prior to transferring them. Wellington also provides follow-up care to high risk babies as a result of their agreement with St. Mary's to allow "back transferring" of stabilized babies. Wellington has a neonatologist-perinatologist on call 24 hours a day. It has neonatal intensive care nurses with Level II and Level III experience on staff 24 hours a day. AHCA questioned the adequacy of the staffing proposed in the CON application because a medical director and respiratory therapists are not explicitly listed on Schedule 6. The medical director will be the same neonatologist- perinatologist who is currently on staff and who will continue to receive professional fees for services, but will not be a hospital employee. That arrangement is explained in the notes to Schedule 6. Similarly, the category "Other Ancillary," Wellington explained in the assumptions to Schedule 6, includes two full-time equivalent staff positions for respiratory therapists. Wellington has on staff two perinatologists, who are doctors specializing in high risk maternal-fetal medical care. One of them moved to Wellington when another NICU program in the County was closed. See Findings of Fact 26. 59C-1.030(2) - health care access criteria Rule 59C-1.030(2), Florida Administrative Code, requires consideration of criteria related to the need for the services proposed and the expected accessibility of the services for residents of the district. The criteria largely overlap with those in Subsections 408.035(1)(b), (d), and (f), and (2), Florida Statutes, which are also related to need and access. See Findings of Fact 20-25 below. In addition to more general need and access issues, the rule requires considerations of access for low income, minorities, and other medically underserved patients, including those receiving Federal financial assistance, Medicare, Medicaid, and indigent persons. The parties stipulated that related criteria in Subsection 408.035(1)(n) - evaluating the applicant's past and proposed Medicaid service - is met or not at issue, based on Wellington's commitment to provide 30 percent Medicaid in the NICU, and historical provision of 32.4 percent Medicaid in the obstetrics unit. By stipulating that the criteria are not at issue or are met in Subsection 408.035(1)(a) - need related to district health plan - the parties necessarily agreed that the local health plan requirement for a commitment to provide at least 30 percent Medicaid/Indigent patient days was met, and so, therefore, is the income accessibility concern of the Rule. Wellington addressed the Rule criterion for minority access to NICU services. The only Haitian doctor specializing in obstetrics and gynecology (OB/GYN) in Palm Beach County, who speaks fluent Spanish as well as Creole, delivers 99 percent of his patients' babies at Wellington. From 60 to 80 percent of his patients come from Lake Worth, most of whom are Haitians and Hispanics, including Gualemalans and Mexicans. Another OB/GYN group of four doctors, with privileges at four different hospitals, delivers 30 to 40 babies a month at Wellington, based on their preference for the care provided at Wellington. The only OB/GYN group in Palm Beach County, which has two affiliated perinatologists, both of whom are on staff at Wellington, serves large numbers of patients from Clewiston, Belle Glade, Pahokee, and Okeechobee. These areas are low income, farming communities located, in driving time, from 45 minutes to 1 1/2 hours west of Wellington. Even when predicted to have high risk births, mothers from the low income areas who are told to go to St. Mary's Hospital because it has a Level II NICU are approximately 70 percent non-compliant. St. Mary's is an additional 45-minute drive east of Wellington. 408.035(1)(b) - availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of like and existing facilities and services; (d) - availability and adequacy of alternatives, such as outpatient or home care; (e) - economics of joint, cooperative, or shared resources; (f) - need for services not reasonably and economically accessible in adjoining areas; and 408.035(2)(a), (b) and (c) - less costly, more efficient or more appropriate alternatives, such as existing inpatient facilities, sharing arrangements; and (d) - serious problems for patients to obtain care without proposed service. In addition to the absence of numeric need under normal circumstances, and the absence of the requisite birth volume which results from the imposition of the district occupancy standard to the hospital, AHCA also determined that Wellington failed to show any problems with patient access to like and existing facilities. Currently, there are 70 licensed and 20 approved Level II NICU beds in District 9. Overall, the occupancy rate for the District is approximately 66 percent. In addition, existing Level II NICU providers are located within two hours driving time for all residents of the district, as required for NICU which is classified as a tertiary service. Seven hospitals in District 9 provided Level II NICU care in 1998 to 1999. These included Lawnwood Regional Medical Center (Lawnwood) in St. Lucie County, Martin Memorial Medical Center (Martin Memorial) in Martin County, and Palm Beach Gardens Medical Center (Palm Beach Gardens) in Palm Beach County, West Boca Raton Hospital (West Boca), St. Mary's Hospital (St. Mary's), Good Samaritan Hospital (Good Samaritan), and Bethesda Memorial Hospital (Bethesda). In addition to the licensed beds, 20 approved beds had been allocated as follows: four for Good Samaritan, ten for Boca Raton Community Hospital, and six for West Boca. All of the existing Level II providers are located in eastern Palm Beach County along the Interstate 95 corridor. The population of Palm Beach County is migrating west. The Wellington community is experiencing significant growth. One indication is approval for the opening of five new schools in Wellington, three elementary, one middle, and a high school approximately 3 miles from the hospital. The number of new residential housing starts in Wellington has increased from 4,332 in 1990 to 6,012 in 1999. The housing starts in Wellington's primary service area represent over 48 percent of the total for Palm Beach County. Approximately 35,000 of the 80,000 women in Palm Beach County aged 35 to 44, who are more likely to have high risk pregnancies, live in the Wellington service area. Births at the three obstetrics providers in western Palm Beach County have increased from 1,441 in 1995 to 2,580 in 1999, including an approximately 200 percent increase at Wellington, from 345 in 1995 to 1,057 in 1999 (for the 12 months ending in August). Prior to October 1, 1999, the two closest hospitals to Wellington with Level II NICU services were Good Samaritan, with seven existing and four approved beds, and St. Mary's, with 22 beds. After Good Samaritan closed its obstetrics and NICU services, the two closest Level II NICU providers to Wellington are St. Mary's and West Boca, with nine licensed and six approved beds. For the 12-month period from July 1998 to June 1999, there were 3,832 NICU II patient days, or 149.98 percent occupancy in the seven operational beds at Good Samaritan; 5,743 patient days, or 71.52 percent in 22 beds at St. Mary's; and 3,210 patient days or 97.72 percent in the nine licensed beds at West Boca. With the closing of Good Samaritan, patients who were using its seven beds were assumed mostly likely to go to St. Mary's, which is owned by the same parent company. AHCA calculated a blended occupancy rate of 84.05 percent for St. Mary's with the addition of nine Good Samaritan beds (seven operational and two of four approved) to its existing 22 beds. Despite the high occupancy in the nearest facilities, the others in the District were relatively low for the same period of time: 39.15 percent in ten Level II NICU beds at Lawnwood, 8.38 percent in five beds at Martin Memorial, 19.23 percent in five beds at Palm Beach Gardens, and 50.46 percent in 12 beds at Bethesda. - immediate or long-term financial feasibility, as related to utilization AHCA rejected Wellington's projection of the volume of babies it would receive as Level II transfers from Glades General Hospital and Palms West Hospital. For the year ending August 1999, there were 737 live births at Glades General and 786 at Palms West. From that, Wellington projected 797 births at Glades General and 850 at Palms West in 2002. From that, Wellington expects to receive 231 transfers from Glades General and 197 from Palms West. The projections are based on historical birth to patient day ratios for the County, reasonable projections of volume, and reasonable market share assumptions. AHCA accepted Wellington's projections of its internal birth volume, which was 1,714 live births by January 31, 2000, resulting in a range between 1,192 and 1,834 Level II days. Based on the reasonableness of the expected transfers and the undisputed reasonableness of internal birth projections, Wellington demonstrated that it will achieve 73.5 percent occupancy in a ten-bed unit, or 75.2 percent in a seven-bed unit, by January 2003. As a result of reasonable utilization projections, as otherwise stipulated by the parties, the project is financially feasible. Factual Summary In general, Wellington demonstrated that the number of live births at Wellington, the closing of the nearest Level II provider, occupancy levels at nearby providers, the distances to other existing providers, particularly from various western areas of its service area, and the demographic and growth patterns within the County are not normal circumstances for the approval of its proposal. On balance, Wellington meets the criteria for approval for approval of CON Number 9253, to convert 16 substance abuse beds to a ten-bed Level II NICU.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order issuing Certificate of Need Number 9253 to Wellington Regional Medical Center, Inc., to convert 16 substance abuse beds to 10 Level II neonatal intensive care beds. DONE AND ENTERED this 25th day of August, 2000, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER 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 25th day of August, 2000. COPIES FURNISHED: Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Mark S. Thomas, Esquire Richard A. Patterson, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building 3, Suite 3431 Tallahassee, Florida 32308-5403 Robert D. Newell, Jr., Esquire Newell, Terry & Rigsby, P.A. 817 North Gadsden Street Tallahassee, Florida 32303-6313
The Issue This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with two violations of Section 458.331(1)(t), Florida Statutes, and one violation of Section 458.331(1)(m), Florida Statutes.
Findings Of Fact Background facts At all times material to this case, the Respondent, Rene A. Munecas, M.D., has been licensed to practice medicine in the State of Florida. Dr. Munecas is board-certified in Obstetrics. As of the date of the events from which the charges in this case arise, Dr. Munecas had practiced obstetrics for approximately 45 years. Dr. Munecas has practiced obstetrics in the State of Florida since 1970. Dr. Munecas was born in Cuba, and he attended medical school in that country. He graduated from the Havana University, School of Medicine, in 1950. He then did a two-year internship in obstetrics at the University Hospital, Havana, Cuba, followed by a two-year residency in obstetrics at the same hospital. Dr. Munecas practiced obstetrics in Cuba until 1961, at which time he moved to the United States. In this country he did a one-year rotating internship at the Highland Park General Hospital, Highland Park, Michigan, followed by a two-residency in obstetrics/gynecology (OB/GYN) at Jackson Memorial Hospital in Miami, Florida. He completed his OB/GYN residency training at Orange Memorial Hospital in Orlando, Florida. Upon completion of his residency training in this country, he practiced in Michigan until 1970, when he moved to Florida. During the many years Dr. Munecas has practiced in Florida, there has been only one prior instance of disciplinary action concerning his practice of medicine. 1/ The prior disciplinary proceeding did not arise from any misconduct by Dr. Munecas, but from concerns as to whether he was "unable to practice medicine with reasonable skill and safety to patients by reason of illness . . . or as a result of any mental or physical condition." 2/ By the time of the final hearing in the prior disciplinary proceeding, all of the medical experts were of the view that Dr. Munecas was able to practice with reasonable skill and safety so long as he continued to be monitored by his treating psychiatrist. The final order in that case (dated August 27, 1984) concluded as follows: ORDERED AND ADJUDGED that Respondent be placed on probation for a period of two (2) years during which time Respondent shall appear semi-annually before the Board and shall continue to be monitored by his treating psychiatrist, Dr. DeJesus who shall submit quarterly reports concerning Respondent to the Board during the two year probation period. No appearances by the treating psychiatrist, Dr. DeJesus, before the Board are required. Facts regarding patient A. B. There is very little evidence in the record of this proceeding concerning the quality or sufficiency of the written medical records kept by Dr. Munecas regarding his treatment of Patient A. B. 3/ There is no clear and convincing evidence that Dr. Munecas failed to keep written medical records justifying the course of treatment of patient A. B. Patient A. B., born July 4, 1965, was seen by Dr. Munecas on August 11, 1994, in the outpatient obstetrical clinic of Baptist Hospital of Miami. She was pregnant with twins. The hospital record indicates periodic visits to the clinic from August 11 through November 17, 1994. Her weight at the initial visit of August 11 was 210 pounds. She was 5 feet, 2 inches, tall. An outpatient ultrasound performed on November 3, 1994, indicated that both twins were in breech position. The results of that ultrasound were reported on November 4, 1994, and were known to Dr. Munecas prior to November 18, 1994, when another outpatient ultrasound was performed on patient A. B. At approximately 6:30 a.m. on November 19, 1994, patient A. B.'s membranes ruptured, and she was taken to the hospital. Dr. Munecas ordered an x-ray of the patient's abdomen for the purpose of ascertaining fetal position. An x-ray of A. B.'s abdomen was taken at about 8:15 a.m. For reasons not clear in the evidence in this case, a second x-ray of A. B.'s abdomen was taken about 10 minutes later. The two x-ray films did not provide any useful information about the position of either of the twins. A few minutes later, Dr. Munecas performed a pelvic examination of patient A. B., for the purpose of trying to determine the positions of the twins. On the basis of that examination Dr. Munecas was of the opinion that twin "A" was in a vertex position, and twin "B" was in a breech position. Later in the day, this opinion was shown to be incorrect. 4/ Dr. Munecas decided it was appropriate to deliver the twins vaginally, and began to take steps to implement that plan of treatment. Among other things, Dr. Munecas attempted to induce labor by administration of Pitocin, which induces labor by increasing uterine contractions. At approximately 5:00 p.m. on November 19, 1994, Dr. Munecas ordered a portable ultrasound examination of patient A. B.'s abdomen. 5/ The ultrasound examination was promptly performed, and by approximately 6:00 p.m. Dr. Munecas received the examination report. The report revealed that both twins were in a breech position. At some point after receiving the report of the ultrasound examination, Dr. Munecas changed his plan of treatment and decided that patient A. B. should be delivered by cesarean section. For reasons not clear from the record in this case, the cesarean section was not done until approximately 10:00 p.m. Twin "A" was delivered at 10:16 p.m., and twin "B" was delivered at 10:19 p.m. Both twins were healthy. Facts regarding current practice of obstetrics Ultrasound imaging is the procedure of choice for obtaining images to show fetal status. Ultrasound is superior to x-ray for such purposes for a number of reasons. Ultrasound produces fetal images that show more details than can be obtained by x-ray. The use of ultrasound also avoids certain potential fetal health risks that are associated with x-rays. Accordingly, except in the most unusual of circumstances, x-rays should not be used to obtain images of fetal status. Under the circumstances presented by patient A. B. on November 19, 1994, a reasonably prudent similar physician would have ordered an ultrasound. If for some reason an ultrasound was not available on the morning of November 19, 1994, a reasonably prudent similar physician would have relied on the results of the ultrasound that was performed on November 3, 1994. Pitocin is a drug that is commonly used by obstetricians to induce and enforce labor. The effect of Pitocin is to increase uterine contractions. Pitocin should only be used when it is desirable to induce labor. The obvious corollary is that Pitocin should never be administered to a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient A. B. because of risks to fetal safety inherent in a situation when twins are both in a breech position. Those risks can be avoided by cesarean section delivery. In circumstances like those presented by patient A. B., with both twins in a breech position, a reasonably prudent similar physician would find it unacceptable to attempt a vaginal delivery. The only acceptable course of treatment under such circumstances would be a cesarean section. 6/ Therefore, it was a departure from standards of care, skill, and treatment acceptable to a reasonably prudent similar physician for Dr. Munecas to attempt to induce labor by patient A. B. Facts regarding patient M. E. Patient M. E., born November 28, 1963, was seen by Dr. Munecas on May 2, 1995, in the outpatient obstetrical clinic of Baptist Hospital of Miami. The hospital record indicates periodic visits to the clinic from May 2 through June 21, 1995. The record also indicates that lab tests had been performed prior to May 2. Dr. Munecas' note for the visit of June 2 indicates his belief that the fetus may have had intrauterine growth retardation. The visits of June 14 and June 21 indicate increases in patient M. E.'s systolic and diastolic blood pressure, and increased protein in her urinalysis. Pre-eclampsia is a term used to describe a form of pregnancy-induced hypertension. Symptoms of pre-eclampsia include elevated blood pressure, presence of protein in the urine and/or the presence of swelling or edema of the hands and feet. A patient exhibiting symptoms of severe pre-eclampsia is at risk for three circumstances of extreme urgency. One is the possibility of a brain hemorrhage, which can be fatal. Second is the possibility of heart failure and pulmonary edema. Third is the possibility of liver hemorrhage, which can cause the liver to swell and burst. This third possibility manifests itself by right upper quadrant abdominal pain. In the early morning hours of June 22, 1995, patient M. E. awoke with severe right upper quadrant abdominal pain. When the pain continued, she called Dr. Munecas at home and described her pain to him. Dr. Munecas instructed her to go to the hospital. At approximately 4:50 a.m. on June 22, 1995, patient M. E. arrived at the hospital. Her blood pressure was taken in the supine position and read 196/111. Patient M. E. complained of continuous severe right upper quadrant abdominal pain. Dr. Munecas was called at home and advised of the patient's status. At that time, Dr. Munecas gave no orders, but indicated his desire for a perinatal consultation. At about 5:00 a.m., the hospital nursing staff called Dr. Lai. Dr. Lai gave no orders, but said that Dr. Munecas should call him at home. Hospital nursing staff called Dr. Munecas a second time at approximately 5:15 a.m. They requested his presence at the hospital to evaluate the patient. At about 6:00 a.m. on June 22, 1995, the hospital nursing staff again called Dr. Munecas and again requested his presence at the hospital. At this time the nursing staff also requested that Dr. Munecas prescribe medication to lower the patient's blood pressure. Dr. Munecas did not prescribe any medications for the patient. Instead, he ordered that an abdominal ultrasound be performed on the patient immediately to see if the patient had gallbladder problems. The ultrasound was promptly performed. It did not reveal any gallbladder problems. At approximately 6:05 a.m., a nurse manager called Dr. Munecas at home, and again requested his presence at the hospital. Dr. Munecas thereupon embarked for the hospital. He arrived at approximately 7:00 a.m. He promptly examined the patient and found her cervix to be dilated up to 2 centimeters. Dr. Munecas' impressions following the examination included "severe pre-eclampsia." Following the examination of patient M. E., Dr. Munecas performed an amniotomy on the patient. Amniotomy is a technique for the induction of labor. It is accomplished by manual rupture of the patient's membranes. An amniotomy should only be performed when it is desirable to induce labor. The obvious corollary is that an amniotomy should never be performed on a patient in which vaginal delivery is contraindicated. Vaginal delivery was contraindicated for patient M. E. for two main reasons. First, following examination of patient M. E., it should have been obvious to any obstetrician that the patient was suffering from severe pre-eclampsia and that prompt action was necessary to minimize the risk of severe harm to the patient's health. Under the circumstances presented by patient M. E., on June 22, 1995, urgent delivery of the baby was the only acceptable course of patient treatment. Under the circumstances presented that day by patient M. E., there was no prospect for her to have an urgent vaginal delivery. A cesarean section was the only prospect for an urgent delivery of patient M. E. The second reason for which vaginal delivery was contraindicated for patient M. E., was the fact that the fetus appeared to have intrauterine growth retardation. Such a fetus is less able than a normal fetus to withstand the rigors of labor. Therefore, such a fetus is at greater risk for possible brain damage or death during vaginal delivery. Such risks are avoided by a cesarean section delivery. By inducing labor in patient M. E., Dr. Munecas exposed both patient M. E. and her fetus to unreasonable dangers which could be avoided by cesarean section delivery. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, would have gone to the hospital as quickly as possible following the first call from the hospital nursing staff describing the patient's status. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. A reasonably prudent similar physician faced with the circumstances presented by patient M. E. on June 22, 1995, in view of the obvious need for urgent relief of the severe pre- eclampsia, would have promptly made arrangements for a cesarean section delivery at the earliest possible time. Dr. Munecas' failure to do so was a departure from acceptable standards of treatment recognized by a reasonably prudent similar physician. Dr. Munecas appears to have voluntarily limited the scope of his medical practice since the incidents which gave rise to this proceeding. He limits his medical practice to gynecology and obstetrics in the office. He no longer performs major surgery or vaginal deliveries.
Recommendation On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect: Dismissing Count Two of the Administrative Complaint; Concluding that the Respondent is guilty of having violated Section 458.331(1)(t), Florida Statutes, as charged in Count One of the Administrative Complaint and as charged in two of the three paragraphs of Count Three of the Administrative Complaint; and Imposing a penalty consisting of a permanent restriction on the scope of the Respondent's medical practice to the following extent: the Respondent is restricted from all hospital-based obstetrical practice and is barred from performing or assisting in the labor or delivery of any hospital obstetrical patient. DONE AND ENTERED this 10th day of February, 2000, in Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 10th day of February, 2000.
The Issue At issue in this proceeding is whether Memorial West should be issued CON 7249 to establish a 10-bed Level II NICU program at its facility in southwest Broward County based on "not normal circumstances." Also at issue is whether the Intervenor, Plantation General Hospital, L.P., has sufficiently demonstrated standing, based on whether its existing NICU service will be substantially adversely affected if Memorial West's proposed project is approved.
Findings Of Fact The agency hereby adopts and incorporates by reference the findings of fact set forth in the Recommended Order except where inconsistent with the rulings on the exceptions.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Plantation General Hospital, L.P. be dismissed as a party to these proceedings based upon its failure to demonstrate standing, and That Certificate of Need No. 7249 be granted to South Broward Hospital District, d/b/a Memorial Hospital West to establish a 10-bed Level II Neonatal Intensive Care Unit at its Pembroke Pines facility. DONE and ORDERED this 20th day of January, 1995, in Tallahassee, Florida. JAMES W. YORK 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 20th day of January, 1995.
The Issue The issues for determination are whether Petitioner should have changed the status of Respondent's license from standard to conditional; and whether Petitioner should impose administrative fines of $7,500 and recover costs for alleged deficiencies in the care of four residents of a nursing home.
Findings Of Fact Petitioner is the state agency responsible for licensing and regulating nursing homes in Florida pursuant to Section 400.23(7), Florida Statutes (2003). Respondent is licensed to operate a 150-bed nursing home located at 2916 Habana Way, Tampa, Florida 33614 (the facility). Respondent admitted Resident 1 to the facility on March 9, 2001. The admitting diagnoses included tracheal bronchitis, diabetes mellitus, morbid obesity, and acute respiratory failure. From the time Resident 1 entered the facility until her death, Resident 1 lived with a tracheal tube in place. Resident 1 died on March 4, 2003, at 10:20 a.m. in the emergency room at St. Joseph's Hospital in Tampa, Florida. The tracheal tube of Resident 1 was completely occluded with hardened secretions when Resident 1 arrived at the hospital. The emergency room (ER) physician that treated Resident 1 testified by deposition. The ER physician diagnosed Resident 1 with respiratory arrest and death. However, the diagnosis is merely a clinical impression and is not a medical determination of the cause of death. No certain cause of death could be determined without an autopsy, and no one performed an autopsy on Resident 1. The diagnosis made by the ER physician is a clinical impression that is an educated guess. The respiratory arrest suffered by Resident 1 could have been precipitated by various causes including an occluded tracheal tube, a heart attack, or acute respiratory failure. The ER physician did not determine that the facility committed any negligence and found no evidence of negligence. The ER nurse who assisted the ER physician believed that the facility had been negligent in clearing the tracheal tube of Resident 1. The ER nurse suspected that secretions had been accumulating in the tracheal tube for several days and that the facility did not monitor or clean the tube because the tube was completely occluded when Resident 1 arrived at the hospital. The ER nurse notified Petitioner of her suspicions. On March 11, 2003, Petitioner conducted a complaint investigation of the facility in connection with the death of Resident 1. Petitioner determined that Respondent either had not assessed whether Resident 1 was capable of performing her own tracheal tube care; or had not monitored the respiratory status of Resident 1 between March 2 and March 4, 2003; or both. Petitioner determined that the alleged failure to assess and monitor Resident 1 violated 42 CFR Section 483.25(k)(4) and (5). Florida Administrative Code Rule 59A- 4.1288 applies the federal standard to nursing homes in Florida. 42 CFR Section 483.25(k)(4) and (5) requires Respondent to "ensure that residents receive proper treatment and care for . . . tracheostomy care (sic) . . . [and] tracheal suctioning." Petitioner assigned the charged deficiency a severity rating of class "II." In relevant part, Section 400.23(8)(b), Florida Statutes (2003), defines a Class II deficiency as one that has: compromised the resident's ability to maintain or reach his or her highest practicable physical, mental and psychosocial well-being, as defined by an accurate and comprehensive assessment, plan of care, and provision of services. Petitioner determined that a Class II rating was appropriate because the facility's alleged failure to provide Resident 1 with appropriate tracheal tube care harmed Resident 1. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7), Florida Statutes (2003). The change in license rating was effective March 11, 2003, when Petitioner completed the complaint survey of the facility. The Conditional rating continued until April 10, 2003, when Petitioner changed the rating to Standard. Petitioner also proposed an administrative fine of $2500 pursuant to Section 400.23(8)(b), Florida Statutes (2003). The preponderance of evidence shows, by various measures, that Respondent provided Resident 1 with proper treatment and care for her tracheotomy tube within the meaning of 42 CFR Section 483.25(k)(4) and (5). First, it is uncommon for a person to cough up material in a tracheal tube and have the material gradually accumulate until the tube closes. It is more likely that secretions coughed up will block the tracheal tube immediately. Second, the emergency medical team (EMT) that treated Resident 1 in the facility did not find it necessary to remove or replace the existing tracheal tube in order to obtain an open airway. Rather, EMT personnel administered oxygen through the existing tube. Third, Resident 1 had normal oxygen saturation levels on March 2, 2003. Finally, Resident 1 was experienced in maintaining her tracheal tube, was capable of clearing her own tube, and asked members of the nursing staff to clear the tube whenever Resident 1 needed assistance. On March 4, 2003, Resident 1 complained of shortness of breath rather than a blocked tracheal tube. The ER physician's testimony shows it is uncommon for a person to cough up material in a tracheal tube and have the material gradually accumulate until the tube closes. The ER nurse that suspected secretions had been accumulating in the tracheal tube of Resident 1 for several days had no experience caring for nursing home residents with tracheal tubes. Gradual accumulations of secretions in a tracheal tube are generally associated with a productive cough from causes such as infiltrated pneumonia. There is no evidence that Resident 1 had such a condition. It is more likely that any material Resident 1 coughed up would have occluded the tracheal tube immediately rather than accumulating over time. EMT personnel that treated Resident 1 in the facility did not find it necessary to remove or replace the existing tracheal tube in order to obtain an open airway. When EMT personnel arrived at the facility, Resident 1 was non- responsive. When confronted with a non-responsive patient, standard protocol requires EMT personnel to ensure an open airway. EMT personnel placed an oxygen "bag" over the existing tube to provide Resident 1 with oxygen. EMT personnel then transported Resident 1 to the hospital emergency room. In the emergency room, the ER physician found the tracheal tube of Resident 1 to be completely blocked with hardened secretions. He removed the tube, replaced it with an open tube, and unsuccessfully attempted to ventilate Resident 1. It is likely the hardened secretions found in the tracheal tube at the emergency room blocked the tube between the time EMT personnel administered oxygen to Resident 1 at the facility and the time the treating physician removed the tracheal tube in the emergency room. A contrary finding would require the trier of fact to speculate that EMT personnel found the tracheal tube to be blocked and administered oxygen to a closed tube; or incorrectly diagnosed Resident 1 with a clear tracheal tube before administering oxygen. There is less than a preponderance of evidence to support either finding. Sudden deposits of hardened secretions in the tracheal tube of Resident 1 are consistent with medical experience. A person with a tracheal tube may develop calcified secretions in their lung known as concretions that can be coughed into the tube and cause it to become instantly blocked. It is unlikely that the hardened secretions found in the tracheal tube at the emergency room were present before Resident 1 collapsed in the facility. Hardened secretions can be cleared with a suctioning device or by coughing them through the tube and out of the opening near the neck if the resident has sufficient muscle strength. Resident 1 was a cognitively alert, 40-year-old, and physically capable of cleaning her own tracheal tube with a suctioning device. Resident 1 also had sufficient muscle strength to cough some secretions through the opening in her tube. Whenever Resident 1 was unable to clear her tube through the suctioning device or by coughing, she became anxious and immediately notified a nurse, who would then suction the tube and clear it for her. On March 2, 2003, Resident 1 complained to a nurse that she was experiencing shortness of breath. Significantly, Resident 1 did not complain that her tracheal tube was blocked. The nurse on duty at the facility notified the treating physician of Resident 1's complaints, and the physician ordered the nurse to measure the oxygen saturation levels of Resident 1. The oxygen saturation levels were within normal range, at 97 percent. The treating physician then ordered bed rest for Resident 1 and ordered the nurse to give Resident 1 a breathing treatment. Resident 1 had no further problems on March 2, 2003. On March 4, 2003, at approximately 9:30 a.m., Resident 1 summoned a nurse to come to her bedside and told the nurse that she did not feel well. Resident 1 did not complain that her tracheal tube was blocked. Her skin color was gray. She then passed out and fell to the floor. Nursing staff immediately called for EMT assistance, and EMT personnel arrived at the facility at approximately 9:32 a.m. EMT personnel transported Resident 1 to the emergency room at approximately 9:52 a.m. Between March 2 and March 4, 2003, the preponderance of evidence shows that the tracheal tube of Resident 1 was clear. Nursing staff at the facility monitored Resident 1 three times on March 3, 2003. Resident 1 had no breathing difficulties and did not express any complaints or discomfort. Resident 1 took her scheduled medications and meals on March 3, 2003. The nurse on duty during the 11 p.m. to 7 a.m. shift for March 4, 2003, provided oxygen and suctioning, "as needed," to Resident 1. This action would have cleared secretions, if any, that would have been "accumulating" in the tracheal tube of Resident 1. Resident 1 placed her finger over the opening to her tracheal tube when she spoke to the nurse about not feeling well on March 4, 2003. Resident 1 covered her tracheal tube to force air around her vocal cords so that the nurse could hear Resident 1. It would not have been necessary for Resident 1 to cover her tracheal tube if the tube were occluded. The findings in paragraphs 25 through 27 are based on notes prepared by the unit manager on March 4, 2003, in response to the directive of the facility's risk manager. The risk manager was responsible for investigating the incident and required all nurses who had contact with Resident 1 on March 3 and 4, 2003, to document their experiences with Resident 1. The unit manager then placed the accounts in the medical record. Petitioner questions the credibility of the unit manager notes because they are late-filed entries in the medical records. The trier of fact finds the unit manager and her notes to be credible and persuasive. The testimony and notes of the unit manager are consistent with the apparent determination by EMT personnel that the tracheal tube was clear. In addition, the Medication Administration Record for March 4, 2003, indicates that Resident 1 received a dose of an ordered medication at 6:00 a.m. and did not complain of not feeling well until some time later. If the notes and testimony of the unit manager were disregarded, the trier of fact cannot ignore the administration of oxygen by EMT personnel. The preponderance of evidence shows that the tracheal tube of Resident 1 was clear when EMT personnel administered oxygen. If it were determined that the tracheal tube of Resident 1 were fully occluded at the facility before Resident 1 collapsed on March 4, 2003, such a finding would alter the outcome of this case. Petitioner failed to show by a preponderance of evidence that an occlusion occurred as a consequence of inadequate assessment or monitoring. Resident 1 had normal oxygen saturation levels on March 2, 2003. The preponderance of evidence does not show that facility staff had reason to believe that the tracheal tube of Resident 1 was occluded after March 2, 2003, and failed to take action to clean the tube prior to the time Resident 1 collapsed on March 4, 2003. There is no preprinted or accepted assessment form for nursing homes to use to assess and monitor the ability of Resident 1 to clean her own tracheal tube. The parties agree that the process involves nothing more than a simple observation of Resident 1 to confirm that she understood and could clean the tracheal tube either by suctioning or coughing. Resident 1 was capable of cleaning her tracheal tube. Relevant orders from the treating physician did not require cleaning to be performed by facility staff. One physician's order indicated that Resident 1 could participate in her own self-care. Another physician's order indicated that Resident 1 was to have "trach care" three times a day, but did not describe the nature and scope of the care or designate who was to provide such care. Another physician's order indicated that Resident 1 was to receive oxygen through her tracheal collar while in bed and "suction trach as needed." However, nothing in the order indicated who was to provide those services. Resident 1 had her tracheal tube for more than a year prior to March 4, 2003. Facility staff routinely observed Resident 1 successfully suctioning and otherwise cleaning her own tracheal tube. Resident 1 also routinely notified staff when she could not remove a blockage in her tube. Facility staff appropriately determined that Resident 1 was capable of performing self-care on her tracheal tube. It was appropriate for facility staff to rely on Resident 1 to inform them if Resident 1 were unable to clean the tube. Her transfer to the hospital on March 4th and her subsequent death were not the product of any inadequate or erroneous assessment or monitoring of Resident 1. On May 12, 2003, Petitioner conducted another complaint investigation of the facility. Petitioner determined that Respondent failed to provide adequate care for pressure sores for three residents identified in the record as Residents 1A, 4, and 5, in violation of 42 CFR Section 483.25(c). Florida Administrative Code Rule 59A-4.1288 applies the federal requirements for pressure sore care to nursing homes in Florida. Petitioner assigned the charged deficiency a class II rating. Petitioner determined that a Class II rating was appropriate because actual harm or a negative outcome allegedly occurred with each of the residents cited in the deficiency. Petitioner changed the license rating for the facility from Standard to Conditional within the meaning of Section 400.23(7), Florida Statutes (2003). The change in license rating was effective May 12, 2003, and continued until June 16, 2003, when Petitioner changed the rating to Standard. Petitioner also proposes a $5,000 fine against Respondent. The fine is calculated by doubling the prescribed fine of $2,500, based on the alleged deficiency in the survey conducted on March 11, 2003, in accordance with Section 400.23(8)(b), Florida Statutes (2003). For reasons stated in previous findings, Respondent committed no violation in connection with the survey conducted on March 11, 2003. The fine for the alleged deficiency found on May 12, 2003, cannot exceed $2,500. Petitioner alleges that the pressure sore care provided by Respondent for Residents 1A, 4, and 5 violated 42 CFR Section 483.25(c). In relevant part, 42 CFR Section 483.25(c) requires a nursing home to ensure that: resident who enters the facility without pressure sores does not develop pressure sores unless the individual's clinical condition demonstrates that they were unavoidable; and a resident having pressure sores receives necessary treatment and services to promote healing, prevent infection, and prevent new sores from developing. 42 CFR Section 483.25(c) Petitioner alleges that Respondent failed to provide Resident 1A with necessary treatment and services to promote healing of an existing pressure sore on the coccyx of Resident 1A. Resident 1A acquired the pressure sore before Respondent admitted Resident 1A to the facility. In April 2003, Resident 1A had surgery to cover the pressure sore with a skin graft taken from her thigh. The surgery required approximately sixty staples to secure the graft. The alleged improper care of Resident 1A is based on several observations made by the surveyor on May 12, 2003. The surveyor observed that the staples used in the surgical process had not been removed even though a physician's order dated April 16, 2003, directed staff to set up an appointment with the plastic surgeon within two weeks of the date of the order. The surveyor found no evidence that staff had scheduled an appointment or taken any other steps to remove the staples. The surveyor observed that the skin was reddened and growing over some of the areas around the staples. The surveyor also observed Resident 1A positioned on her back in bed in such a manner that her weight was on her coccyx area. The area in question was not a pressure sore. Petitioner has adopted a written definition of a pressure sore in the guidelines that Petitioner requires its surveyors to use in interpreting the federal regulation at issue. In relevant part, the guidelines define a pressure sore as: . . . ischemic ulceration and/or necrosis of tissues overlying a bony prominence that has been subjected to pressure, friction or sheer. If the area of concern were the area over the coccyx of Resident 1A, that area would have been over a "bony prominence" within the meaning of definition of a pressure sore. However, it is undisputed that the area of concern for Resident 1A was located in the fleshy part of the buttocks where staples were used to secure the skin flap to the skin. The area of concern was a surgical wound site, rather than a pressure sore because of its origin and location. The preponderance of evidence shows that the area of concern failed to satisfy the definition of a pressure sore adopted by Petitioner. Section 120.68(7)(e), Florida Statutes (2003), prohibits Petitioner from deviating from its officially stated policy unless Petitioner explains the deviation. Petitioner failed to provide any evidence to explicate legitimate reasons for deviating from its written definition of a pressure sore in this case. Assuming arguendo the staples around the wound site were a pressure sore, the preponderance of evidence shows that Respondent provided necessary treatment to promote healing. Respondent turned and repositioned Resident 1A every two hours in accordance with standard protocol. That schedule included a period during which Resident 1A was on her back in bed, with the head of her bed elevated. The single observation by the surveyor of Resident 1A on her back in bed did not show that Respondent failed to properly turn and reposition Resident 1A. The failure to timely comply with the physician's order for Resident 1A to consult with a plastic surgeon did not deprive Resident 1A of the care necessary to promote healing of a pressure sore. The removal of staples from a skin flap is not an element of required care for a pressure sore. Rather, removal of staples is part of the established care for a surgical wound site. The failure to timely provide a consult was not a violation of the requirements for care of pressure sores. If the removal of staples were required for treatment of pressure sores, the failure to timely obtain a consult and the failure to timely remove the staples did not cause harm to Resident 1A. The undisputed purpose of the physician's order to see a plastic surgeon was to evaluate whether the staples should be removed from the wound site. Respondent removed the staples from the wound site shortly after the survey with no complications to the resident. The surgical wound site healed in a timely and complete manner. The absence of harm to Resident 1A precludes a rating as a Class II deficiency. Petitioner alleges that Respondent allowed avoidable pressure sores to develop on Resident 4 and failed to provide necessary treatment after the pressure sores developed. During the survey, the surveyor and a nurse, who was a clinical consultant to the facility, twice observed Resident 4 lying on a special air mattress that was not inflated. After the second observation, the surveyor and consultant examined Resident 4 and observed what each determined to be two stage II pressure sores on each of the outer heels of Resident 4, a stage IV pressure sore on the right toe, two stage II areas on her left side above her rib cage, and a stage II area under her left breast. The surveyor and the nurse-consultant found nothing in the medical record to indicate that these areas had been previously identified by facility staff. Nor did they find any treatment orders for the areas of concern. The areas of concern were not pressure sores. It is undisputed that pressure sores involve deep tissue damage, do not heal quickly, and would have been present a few days later during examination. The director of nursing and the wound care nurse for the facility examined Resident 4 on May 13, 2003, and found no evidence of the areas that caused concern to the surveyor and nurse-consultant on May 12, 2003. The director of nursing asked the treating physician to examine Resident 4 to confirm the director's observations. On May 19, 2003, the treating physician examined Resident 4 and found no areas of concern on Resident 4. Resident 4 had no conditions that placed her at risk for developing pressure sores. The failure to inflate the special air mattress under Resident 4 did not create any risk for pressure sores. The mattress had not been ordered for Resident 4 and was not necessary for her care because Resident 4 was not at risk for developing pressure sores. Resident 4 was on the mattress because she had moved into a new room, and facility staff had not yet removed the mattress from the bed in the room that was used by the previous occupant. Petitioner alleges that Respondent failed to provide necessary treatment to promote healing of existing pressure sores on Resident 5. Resident 5 had three open areas on his skin: one on each hip and one over the coccyx. The areas on each hip were surgical wounds from hip surgeries prior to admission to the facility. For reasons stated in previous findings, these areas were surgical wound sites and were not pressure sores. It is undisputed that the remaining area on Resident 5 was a stage II pressure sore over the coccyx that was present upon admission to the facility. During the survey, the surveyor and the nurse-consultant observed Resident 5 on a specialty air mattress that contained a number of air chambers. Two of the chambers were not inflated. The surveyor and nurse-consultant determined that the area over the coccyx had worsened to a stage IV pressure sore. Petitioner alleges that Respondent failed to provide necessary care to Resident 5 by failing to properly inflate his specialty air mattress during the survey. Respondent did not fail to properly inflate the air mattress for Resident 5. The level of inflation of that mattress is not determined or set by the facility. Rather, the manufacturer calculates and sets the level of inflation for the mattress. The alleged failure to properly inflate the air mattress did not cause harm to Resident 5. The director of nursing observed the area of concern the day after the survey and determined it to be a stage II, rather than a stage IV, pressure sore. The clinical records that charted the size and stage of the pressure sore for the month after the survey show that the area was never more than a stage II pressure sore. A stage IV pressure sore would not have improved to a stage II sore within a month. Petitioner failed to show by a preponderance of the evidence that the alleged improper inflation of an air mattress caused the pressure sore on Resident 5 to worsen from a Stage II to a Stage IV pressure sore.
Recommendation Based on the foregoing findings of fact and conclusions of law, It is RECOMMENDED that Petitioner enter a Final Order deleting the disputed deficiencies from the survey reports for March 11 and May 12, 2003; replacing the Conditional ratings with Standard ratings; and dismissing the proposed fines and investigative costs with prejudice. DONE AND ENTERED this 2nd day of March, 2004, in Tallahassee, Leon County, Florida. S DANIEL MANRY 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 March, 2004. COPIES FURNISHED: Gerald L. Pickett, Esquire Agency for Health Care Administration Sebring Building, Suite 330K 525 Mirror Lake Drive, North St. Petersburg, Florida 33701 Donna Holshouser Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300 R. Davis Thomas, Jr. Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Box 11300 Tallahassee, Florida 32302-1300 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration Fort Knox Building, Suite 3116 2727 Mahan Drive Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308
The Issue Whether the application of Wuesthoff Memorial Hospital, Inc. d/b/a Wuesthoff Memorial Hospital ("Wuesthoff"), for the conversion of ten acute care beds to ten Level II neonatal intensive care beds meets, on balance, the applicable statutory and rule criteria for approval.
Findings Of Fact Wuesthoff Memorial Hospital, Inc., d/b/a Wuesthoff Memorial Hospital ("Wuesthoff") is a 303 bed acute care hospital in Rockledge, Florida, in Brevard County, District 7. The Agency For Health Care Administration ("AHCA") is the state agency designated by statute to issue, revoke, or deny Certificates of Need ("CON") for health care beds and services. Wuesthoff is the applicant for a CON to convert ten acute care beds to a ten bed Level II neonatal intensive care unit ("NICU"), for total project costs of $1,239,330. By prehearing stipulation, the parties agreed to the following facts: the fixed need pool for Level II NICU beds for District 7 shows zero net numeric bed need; there are 41 licensed and 18 approved Level II NICU beds in District 7, 10 in Brevard County, 49 in Orange County, none in Osceola and Seminole Counties; the letter of intent and CON application were filed timely and properly deemed complete; Wuesthoff does not have any approved Level II NICU beds; the District 7 Health Plan, including the 1991 CON Allocation Factors, are applicable to the review of this application; and the 1989 State Health Plan is also applicable to the review of this application. With regard to the statutory criteria, the parties also agreed that: Wuesthoff's historic record of providing high quality care is not in dispute; Wuesthoff does not maintain that its NICU service will be intended as a research and education facility; the availability of resources, including management personnel and funds for capital and operating expenditures, for project accomplishment and operation, is not in dispute; the immediate and long term financial feasibility of the proposal as demonstrated in Wuesthoff's application are not in dispute, assuming Wuesthoff proves the accuracy of utilization assumptions; Wuesthoff does not provide a substantial portion of services or resources to individuals not residing within the district or in adjacent districts; Wuesthoff's past levels of service to Medicaid and medically indigent patients are not in dispute; the special needs and circumstances of health maintenance organizations are not applicable to this application; and the costs and methods of proposed construction are not in dispute. At issue in this case are the statutory review criteria in Subsections 408.035(1)(a), (b), (d), (e), (f), portions of (h) and (i), (j) and (l), Florida Statutes (1992 supp.). Subsections 408.035(2)(a), (b), (c) and (d) are also in dispute. NEED Subsection 408.035(1)(a) requires consideration of need in relation to state and local health plans. The 1989 State Health Plan and CON allocation factors in the 1991 District 7 Health Plan are applicable to the review of Wuesthoff's CON application. Wuesthoff is not located in Orange County and, therefore, does not meet the District 7 factor favoring Orange County providers who will serve Medicaid newborns. The second factor favors applicants proposing to provide at least 45 percent of all patient days to Medicaid patients and 6 percent to indigent patients. Wuesthoff projected that it would achieve 50.5 percent Medicaid patient days and 4.5 percent to uninsured patients. Despite these projections, Wuesthoff failed to make a commitment to have its CON conditioned on the provision of specified percentages Medicaid and indigent patient days. On this basis, AHCA concluded that Wuesthoff fails to meet the factor. Wuesthoff's position is accepted. Its projections justify favorable consideration under this factor, its historic Medicaid service supports its projections, and AHCA can condition the CON if appropriate. The third factor requires applicants to identify specific services, educational programs, and/or interventions which will provide for an unmet need. This factor is also related to Subsection 408.035(1)(b) - the availability and accessibility of existing and approved Level II NICU beds in the district; (2)(a) - the availability of less costly more efficient facilities; and (2)(c) and (d) - availability and efficiency of existing inpatients facilities, and problems in obtaining existing inpatient care in the absence of the proposed services. There is no dispute that there is zero numeric need for additional Level II NICU beds in District 7. Level II beds exist at Holmes Regional Medical Center ("Holmes") in Melbourne Brevard County, and in Orange County at Winter Park Memorial Hospital ("Winter Park"), Orlando Regional Medical Center ("ORMC") and Florida Hospital. Holmes, the only Level II NICU in Brevard County, is, however, not available because its 10 Level II NICU beds have had occupancy levels not less than 122 percent and up to 147 percent during the past three years. Holmes provided 36.8 percent of the NICU services in District 7, with ten of the 59 licensed or approved beds, or 17 percent of the District beds. There was also evidence that Holmes' physicians do not accept transfers of indigent or Medicaid obstetrics patients from the service area of Wuesthoff and from northern Brevard County. In 1992, district wide occupancy in Level II NICU beds was over 95 percent. All of the other providers, except Holmes, are located in Orange County. Winter Park's 1992 occupancy rate was only 34 percent in its 5 bed unit. Florida Hospital, with a 1992 rate of 87.8 percent in 14 beds, has been approved for 8 additional beds. ORMC, with a 1992 occupancy rate averaging 90.2 percent, has approval for an additional 10 beds. Available beds at Winter Park or Florida Hospital have not historically alleviated overcrowding at Holmes. At hearing, AHCA's expert health planner testified that Holmes reached 122 percent occupancy when Winter Park was at 30 percent and Florida Hospital was 58.2 percent. Wuesthoff has demonstrated that Winter Park, Florida Hospital, and ORMC are geographically and economically inaccessible to Medicaid and indigent patients in Wuesthoff's service area. Expert testimony linked indigency to a greater need for NICU care. Wuesthoff demonstrated that Medicaid and indigent obstetrics patients in its service area cannot and do not use the facilities in Orange County adequately and appropriately for prenatal care or delivery due to transportation and economic difficulties. Indigent patients with high risk pregnancies served by the Brevard County Public Health Unit are referred to ORMC. Experts estimated that fewer than 50 percent of those end up delivering at ORMC. For Medicaid patients who comply with referrals for prenatal care, Medicaid is charged $119 per patient per non-emergency, pre-scheduled trip to ORMC. For infants born in Brevard County in need of Level II care, emergency transportation to ORMC costs $700 by ambulance or over $2000 by helicopter. The number of Public Health medicaid or indigent obstetrics patients referred to ORMC from the Wuesthoff area was reasonably estimated to be 250 patients a year. With 50 percent of the babies needing Level II care, the estimate of 125 neonatal referrals is reasonable. The statutory criterion of need in relation to the State Health Plan also requires consideration of preferences for applicants (1) converting from acute care to NICU beds; (2) proposing to serve Children's Medical Services ("CMS"), Medicaid and charity patients; and (3) proposing to serve substance abusing pregnant and postpartum women. AHCA agreed that the Wuesthoff CON application meets all of the applicable State Health Plan preferences. Wuesthoff is proposing, as also required by AHCA rule, to convert acute care beds, currently utilized at 56.33 percent occupancy. In 1992, Medicaid obstetric patients days accounted for 50.5 percent of the total. A CMS clinic is located on the Wuesthoff campus and receives services from its staff pediatricians. See also, 59C-1.042(3)(j) and (k), F.A.C. Wuesthoff demonstrated the absence of any outpatient alternatives for Level II NICU beds, as required in Subsection 408.035(1)(d), Florida Statutes, (1992 supp.). Wuesthoff fails to comply with the criteria in Subsections 408.035(1)(e), (f), (g), (j) and (k), Florida Statutes, (1992 supp.). It does not plan to jointly operate a NICU with other providers, although it is under consideration as a satellite regional perinatal intensive care center ("RPICC"). The proposed services are available in adjoining areas, including Volusia County to the north, where Level II NICU occupancy was 85 percent in 1992. Wuesthoff does not intend to be a research or educational facility, nor will it serve substantial numbers of individuals residing outside its service district. Wuesthoff is not a health maintenance organization hospital. UTILIZATION AND OPERATIONS Pursuant to Subsections 408.035(1)(h), (i) and (l), and (2)(a), Wuesthoff must be able to staff and fund a Level II NICU that is financially feasible and does not impact negatively health services quality or costs. AHCA presented no evidence at hearing to contradict that presented by Wuesthoff to show that it has the staff and funds for its proposed project. Wuesthoff also has shown that it will profit from the conversion of underutilized acute care beds to Level II NICU beds. Rule 59C-1.042, Florida Administrative Code, includes the methodology for calculating numeric need, among other requirements for approval of Level II NICU programs. Numeric need, under the rule, is zero. In fact, the calculations show that 15 more Level II beds than needed have been approved in District 7. As required by the rule, average occupancy rates in District 7 exceeded 80 percent in the 12 months ending 6 months prior to the quarter in which numeric need was calculated. The rule also favors RPICC's. Wuesthoff is not a RPICC, although it is under consideration as a satellite of the ORMC RPICC. Wuesthoff is not an existing provider of Level II NICU services, and therefore, does not qualify for additional beds under the rule. As required by the NICU rule, Wuesthoff's application seeks the establishment of the minimum size Level II unit of ten beds. The applicant also has on staff a neonatologist, a head nurse with experience and training in neonatal intensive care, registered nurses, respiratory therapists, and social services personnel with the required training. Wuesthoff is capable of performing the blood gas analyses, clinical laboratory support services, and intervention screening. If approved, Wuesthoff would also be eligible to participate in a county grant-funded neonatal developmental disabilities program. Wuesthoff either has installed or has made appropriate plans to obtain the equipment and to make the renovations required by Subsections (9)(b) and (c) of the Rule. Wuesthoff is capable of meeting the data reporting requirements of Subsection 13 of the Rule. The two hour travel time for geographic access to Level II NICU services is met by the existing District 7 providers, and Wuesthoff's proposal is not needed to meet that standard. MINIMUM BIRTH VOLUME Rule 59C-1.042(6), provides in relevant part, as follows: Hospitals applying for Level II NICU services shall not normally be approved unless the hospital had a minimum service volume of 1,000 live births for the most recent 12- month period ending 6 months prior to the beginning date of the quarter of the publication of the fixed need pool. Wuesthoff does not meet the 1000 minimum number of births. In 1991, there were 963 live births at Wuesthoff. From 1988-1990, live birth at Wuesthoff exceeded 1000. In 1992, Wuesthoff had 998 live births. AHCA asserts that the quality of care that volume requirements assure will be adversely affected by the approval of Wuesthoff's application. Wuesthoff has presented competent, substantial evidence that this concern is not well founded, for the following reasons: A privately-owned Birthing Center located on Merritt Island in Brevard County, is staffed by a doctor who owns the facility and has hospital privileges only at Wuesthoff. At the Birthing Center, there were 124 deliveries in 1990, 156 in 1991, and 178 in 1992. The Birthing Center, Jess Parrish Memorial Hospital in Titusville, and Cape Canaveral Hospital, all are Brevard County obstetrics facilities without Level II NICU services. In fact, births at Cape Canaveral exceeded 1000 in 1992. The live births in these three Brevard County facilities, at Wuesthoff, and the overcrowding at the Level II NICU at Holmes, provide a reasonable basis to conclude that Wuesthoff can exceed the minimum birth volume necessary to meet the quality of care objectives of the rule. As required by Subsections (11) and (12) of the NICU rule, Wuesthoff has 24 hour emergency transportation in cooperation with Jess Parrish Memorial Hospital and Cape Canaveral Hospital. Wuesthoff has a transfer agreement with ORMC, which has all levels of NICU care. AHCA also questioned Wuesthoff's utilization assumption and projections. With combined live births at Brevard facilities without Level II NICUs exceeding 3,000 a year, with two of the facilities jointly operating an emergency transportation service with Wuesthoff, and the third staffed by a obstetrician with privileges only at Wuesthoff, Wuesthoff's assumptions that the majority of neonates born at these facilities needing Level II NICU care will be transferred to Wuesthoff are reasonable. As agreed in the prehearing stipulation, because utilization projections are found reasonable, Wuesthoff's proposal is financially feasible.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be issued approving Certificate of Need 7081 to Wuesthoff Memorial Hospital to convert ten acute care beds to a ten bed Level II neonatal intensive care unit condi tioned upon Wuesthoff's providing not less than a combined total of 51 percent Medicaid and indigent patient days in the unit. DONE AND ENTERED this 10th day of November, 1993, in Tallahassee, Leon County, Florida. ELEANOR M. HUNTER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 10th day of November, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 93-0963 To comply with the requirements of Section 120.59(2), Fla. Stat. (1991), the following rulings are made on the parties' proposed findings of fact: Petitioner's Proposed Findings of Fact. Accepted in Finding of Fact 1. Subordinate to Finding of Fact 33. Accepted in Finding of Fact 4. Accepted in Finding of Fact 4. Accepted in Findings of Fact 11, 12, and 13. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 15 and 17. Subordinate to Findings of Fact 12 and 13. Accepted in Finding of Facts 15 and 18. Accepted in Finding of Fact 15. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 17. Accepted in Finding of Fact 17. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 17. Accepted in Finding of Fact 15. Accepted in Finding of Fact 17. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 16. Accepted in Finding of Fact 12. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 16. Accepted in Finding of Fact 15. Accepted in Finding of Fact 15. Accepted in Conclusions of Law 40. Accepted in Finding of Fact 15. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 15. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 12. Subordinate to Finding of Fact 16. Accepted in Finding of Fact 21. Accepted in Finding of Fact 16 and 17. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 12. Accepted in Finding of Fact 28. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 16 and 17. Subordinate to Findings of Fact 16 and 17. Accepted in Findings of Fact 21 and 26. Accepted in Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Subordinate to Findings of Fact 21 and 26. Accepted in Finding of Fact 17. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 17. Subordinate to Finding of Fact 18. Accepted in Finding of Fact 35. Subordinate to Findings of Fact 35. Subordinate to Finding of Fact 12 and 35. Accepted in Finding of Fact 19. Accepted in Finding of Fact 19. Accepted in Finding of Fact 9. Accepted in Finding of Fact 9. Accepted in Finding of Fact 78. Accepted in Conclusions of Law 39. Accepted in Finding of Fact 12-15. Accepted in Finding of Fact 12. Accepted in Finding of Fact 12. Accepted in Finding of Fact 12-13. Accepted in Finding of Fact 12. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in relevant part in Finding of Fact 32. Accepted in Finding of Fact 20. Rejected Conclusion in Findings of Fact 21. Rejected Conclusion in Findings of Fact 21. Rejected Conclusion in Findings of Fact 21. Accepted in Finding of Fact 23. Accepted in Finding of Fact 23. Accepted in Finding of Fact 17. Accepted in Finding of Fact 33. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Accepted in Finding of Fact 23. Accepted in Finding of Fact 5. Accepted in Finding of Fact 9. Accepted in Finding of Fact 9. Accepted in Finding of Fact 9. 105. Accepted in Findings of Fact 10-17. 106. Accepted in Finding of Fact 12. 107. Accepted in Finding of Fact 15. 108. Accepted in Finding of Fact 14. 109. Accepted in Finding of Fact 12. 110. Accepted in Finding of Fact 15. 111. Accepted in Findings of Fact 10-17. 112. Accepted in Findings of Fact 10-17. 113. Accepted in Finding of Fact 24. 114. Accepted in Finding of Fact 24. 115. Accepted in Finding of Fact 25. 116. Accepted in Conclusions of Law 42. 117. Accepted in Finding of Fact 19. 118. Accepted in Finding of Fact 19. 119. Accepted in Finding of Fact 28. 120. Accepted in Finding of Fact 28. 121. Accepted in Finding of Fact 33. 122. Accepted in Finding of Fact 31. 123. Accepted in Finding of Fact 28. 124. Accepted in Finding of Fact 29. 125. Accepted in Finding of Fact 34. 126. Accepted in Finding of Fact 34. 127. Accepted in Finding of Fact 30. 128. Accepted in general in Conclusions of Law 42. 129. Accepted in Finding of Fact 11. 130. Accepted in Findings of Fact 13 and 24. 131. Accepted in Finding of Fact 14. Respondent's Proposed Findings of Fact. Accepted in Findings of Fact 1 and 4. Accepted in Finding of Fact 3. Accepted in Finding of Fact 4. Accepted in Finding of Fact 4. Accepted in Finding of Fact 8. Rejected in Findings of Fact 9. Rejected in Findings of Fact 10. Accepted in Finding of Fact 19. Accepted in Finding of Fact 19. Accepted in Conclusions of Law 40. Rejected in Conclusions of Law 41. Accepted in Finding of Fact 4. Accepted in Finding of Fact 4. Accepted in Finding of Fact 24. Accepted in Finding of Fact 13. Accepted in Finding of Fact 25. Accepted in Finding of Fact 13. Accepted in Finding of Fact 4. Accepted in Findings of Fact 21 and 26. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Subordinate to Finding of Fact 21. Accepted in Finding of Fact 31. Accepted in Findings of Fact 16 and 17. Subordinate to Finding of Fact 16. Accepted in Findings of Fact 15-17. Accepted in Finding of Fact 17. Accepted in Finding of Fact 17. Accepted in Finding of Fact 16. Subordinate to Finding of Fact 16. Subordinate to Finding of Fact 16. Rejected in Findings of Fact 12. Accepted in Finding of Fact 35. Accepted in Finding of Fact 12. Rejected first sentence in Finding of Fact 35. Accepted in Finding of Fact 35. Accepted in Finding of Fact 5. Accepted in Finding of Fact 28. Accepted in Finding of Fact 33. Accepted in Finding of Fact 33. Accepted in Finding of Fact 28. Accepted in Finding of Fact 34. Accepted in Finding of Fact 34. Accepted in Finding of Fact 35. Accepted in Finding of Fact 5. Accepted in Finding of Fact 20. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Accepted in Findings of Fact 5 and 22. Accepted in Findings of Fact 5 and 22. Accepted in Finding of Fact 21. Accepted in Finding of Fact 23. Accepted in Findings of Fact 5 and 36. Accepted in Finding of Fact 35. Subordinate to Finding of Fact 35. Accepted in Conclusions of Law 40. Subordinate to Finding of Fact 35. Rejected in Findings of Fact 35. Rejected in Findings of Fact 36. Accepted in Finding of Fact 21. Accepted in Finding of Fact 21. Rejected in Findings of Fact 35. Accepted in Finding of Fact 5. Accepted in Finding of Fact 5. Accepted in Finding of Fact 9. Rejected in Findings of Fact 10-17. Rejected first sentence in Findings of Fact 10-17. Rejected in Findings of Fact 10-17. COPIES FURNISHED: Kenneth F. Hoffman, Attorney Patricia A. Renovitch, Attorney OERTEL, HOFFMAN, FERNANDEZ & COLE, P.A. Post Office Box 6507 Tallahassee, Florida 32302 Lesley Mendelson, Senior Attorney Agency For Health Care Administration The Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303 Sam Power, Agency Clerk Agency For Health Care Administration The Atrium Building, Suite 301 325 John Knox Road Tallahassee, Florida 32303
The Issue Whether the Respondent committed the violations alleged in the Administrative Complaint filed July 7, 2006, and, if so, the penalty that should be imposed.
Findings Of Fact Based on the oral and documentary evidence presented at the final hearing and on the entire record of this proceeding, the following findings of fact are made: The Department is the state agency responsible for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida. See § 455.225, Fla. Stat. (2006). The Board is the entity responsible for regulating the practice of medicine in Florida and for imposing penalties on physicians found to have violated the provisions of Section 458.331(1), Florida Statutes. See § 458.331(2), Fla. Stat. (2006). Dr. Edison is, and was at the times material to this matter, a physician licensed to practice medicine in Florida, having been issued license number ME 44240. Dr. Edison received his medical degree from the University of Massachusetts; did his residency in general surgery at the Kaiser Foundation in Los Angeles, California; and did a residency in plastic surgery, with specialties in reconstructive surgery and cosmetic surgery. Dr. Edison is certified in plastic surgery by the American Board of Plastic Surgery and is a lifetime diplomate of that Board. Dr. Edison was also certified in Advanced Cardiac Life Support ("ACLS") at the times material to this proceeding. Dr. Edison has been practicing plastic surgery in Florida for 22 years. Prior to the time material to this proceeding, Dr. Edison performed approximately 150-to-200 breast augmentation surgeries each year and approximately 100-to-150 liposuction procedures each year. Dr. Edison practices at the Cosmetic Surgery Center, which is an office that contains two operating rooms, a recovery room, and an overnight recovery facility that is staffed by an ACLS-certified nurse for patients who undergo procedures such as stomach tucks or facelifts. Dr. Edison's surgical practice is limited to Level II office surgery, which is defined in Florida Administrative Code Rule 64B8-9.009, Standard of Care for Office Surgery, in pertinent part as follows: Level II Office Surgery. Scope Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or rectally, this making intra and post- operative monitoring necessary. . . . Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition. Standards for Level II Office Surgery. * * * 4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. . . . The level of pain and anxiety management achieved under Level II sedation is determined by the type of drugs administered and the dosages in which they are administered. Dr. Edison was ACLS certified and was, therefore, authorized to use the services of a registered nurse to administer the drugs that bring patients to Level II sedation. He does not use the services of an anesthesiologist or of a Certified Registered Nurse Anesthetist in his surgical facility. Patient P.L. P.L. first consulted with Dr. Edison on July 5, 2005. P.L. filled out a portion of a Patient Information form, and Dr. Edison took a general medical history from P.L., but he did not weigh P.L. during this initial visit, and the Patient Information form does not include her blood pressure, height, or weight. Dr. Edison found P.L. to be a healthy 29-year-old female, the mother of three children, who had no known allergy or adverse reaction to any medication. P.L. wanted breast implants, and, upon examination, Dr. Edison found that P.L. would be a good candidate, anatomically, for the surgery. Dr. Edison spent the majority of time during this initial consultation talking with P.L. and her husband, A.A., about the various breast implant options. He also discussed with them the risks and possible complications of the surgery. After her visit to Dr. Edison's office on July 5, 2005, P.L. notified Dr. Edison's office that she had decided to have the surgery. Dr. Edison had a cancellation on July 7, 2005, and P.L. was scheduled for surgery for 8:00 a.m. on that date. P.L. returned to Dr. Edison's office on July 6, 2005, for a pre-operative examination. At that time, Dr. Edison did an examination during which he checked P.L.'s heart, lungs, blood pressure, and pulse rate, and he noted the results in his examination notes dated July 6, 2005. He found nothing abnormal and concluded that P.L. was a 29-year-old patient in perfect health, with no known allergy or adverse reaction to any medication. Dr. Edison also had blood drawn during the July 6, 2005, office visit, which was sent to a laboratory for testing. The laboratory report was completed at 8:21 a.m. on July 7, 2005, and showed nothing abnormal. P.L. presented herself at Dr. Edison's office on July 7, 2005, at approximately 8:00 a.m. She was examined by Dr. Edison at 8:10 a.m., and he stated in his office notes that she had decided on the 300 cubic centimeter implant. There were no notations of her vital signs in his office notes. Dr. Edison intended for P.L.'s breast augmentation surgery to be Level II office surgery, and he noted this on P.L.'s Immediate Pre-Op Evaluation, which he completed on July 7, 2005. He also decided to use the transaxillary technique, making incisions under the arms through which to insert the implants under the muscle in P.L.'s chest. Dr. Edison was assisted during surgery by Michelle Hoff, an Advanced Registered Nurse Practitioner, who administered the sedatives and other drugs to P.L. under Dr. Edison's direction. Dr. Edison was also assisted by Liliana Gabor, a surgical technician. Ms. Hoff is not a Certified Registered Nurse Anesthetist, nor has she received any formal training in administering sedative drugs or anesthesia. She has a significant amount of experience administering drugs for pain and anxiety management. Her experience administering drugs to achieve Level II sedation consists of an externship with Dr. Edison while working on her master's degree in nursing and extensive on-the-job training while working in the operating room with Dr. Edison, which she has done every day since beginning to work with Dr. Edison full-time in November 2003. At some point immediately prior to surgery, Dr. Edison asked P.L. her weight, which she reported as 95 pounds, or 43 kilograms, on the morning of surgery. Dr. Edison needed to know P.L.'s weight in order to calculate the correct dosage of the drugs she would be given, and he wrote "95 lbs" on the outside of P.L.'s folder. Dr. Edison noted P.L.'s weight on the outside of the folder so it would be plainly visible to Ms. Hoff when she had the chart on the anesthesia stand.4 Dr. Edison did not enter P.L.'s weight in his examination notes, and the only other mention of P.L.'s weight in the medical records maintained by Dr. Edison is the notation "<100 lbs" on a sheet containing the contact numbers for P.L. and for her husband, who would be picking her up after surgery. At approximately 8:20 a.m. on July 7, 2005, P.L. walked to the operating room. Working under Dr. Edison's direction, Ms. Hoff hooked P.L. up to various monitoring devices, so that her heart, blood pressure, and oxygen saturation level could be monitored during surgery. Her vital signs were noted on the anesthesia chart by Ms. Hoff; at 8:20 a.m., P.L.'s heart rate was approximately 104. At 8:20 a.m., Ms. Hoff began to administer drugs to P.L. to achieve Level II sedation in accordance with directions from Dr. Edison; she documented the name of the drugs she administered, together with the time and dosage administered; she monitored and documented P.L.'s vital signs, including heart rate, blood pressure, and oxygen saturation level; and she maintained anesthesia notes. At 8:20 a.m., Ms. Hoff administered two milligrams of Valium; one gram of Ancef, and 0.2 milligrams of Robinol at Dr. Edison's direction. At 8:25 a.m., she administered 10 milligrams of Ketamine and 10 milligrams of Talwin and started the administration of Diprivan by microdrip at the rate of approximately 25 micrograms per kilogram of weight per minute. Ms. Hoff's notes do not indicate the manner in which she administered the Diprivan, nor the dosage or rate of administration. Ms. Hoff also administered nitrous oxide and oxygen at 8:25 a.m., and she noted that Dr. Edison also began administering local anesthetic by injection at 8:25 a.m. Ms. Hoff noted that P.L. was responding to verbal stimuli. Ms. Hoff was not involved with the preparation or administration of local anesthetic to P.L. Dr. Edison prepared a dilute solution of 70 cubic centimeters of 1% Lidocaine with epinephrine with 350 cubic centimeters of saline solution and 10 cubic centimeters of 1/2% marcaine. At approximately 8:25 a.m., Dr. Edison began injecting the Lidocaine solution, which totaled approximately 700 milligrams or approximately 14 milligrams of Lidocaine per kilogram of P.L.'s body weight and 50 milligrams of marcaine, into the tissue surrounding P.L.'s breasts. At 8:30 a.m., Ms. Hoff, at Dr. Edison's direction, administered another 10 milligrams of Talwin. At 8:35 a.m., P.L.'s heart rate was 112 beats per minute and her blood pressure was 142/102. At Dr. Edison's direction, Ms. Hoff administered 1/4 cubic centimeter of Labetalol to help control P.L.'s blood pressure. Ms. Hoff noted that P.L. tolerated the Labetalol well and was responsive to verbal stimuli. At 8:45 a.m., Ms. Hoff noticed a brief facial twitch on P.L.'s face, which is an indication of a possible seizure. At Dr. Edison's direction, she immediately stopped administering all sedatives, and the surgery was cancelled. At Dr. Edison's direction, Ms. Hoff administered 2.5 milligrams of Valium to keep P.L. sedated and to help control the seizure, together with three liters of oxygen by mask. At 8:55 a.m., Ms. Hoff administered another 2.5 milligrams of Valium at Dr. Edison's direction,5 and she noted that P.L.'s status was unchanged, by which Ms. Hoff meant that P.L.'s airway, breathing, and circulation were maintained, that her vital signs were stable, and that she remained responsive to verbal stimuli. Between 8:55 a.m. and 9:15 a.m., P.L.'s status was unchanged. According to Ms. Hoff's notes, P.L.'s airway, breathing, circulation, and vital signs were maintained at normal levels, and she responded well to the Valium and oxygen. Ms. Hoff observed during this time that P.L. was lethargic and appeared to be a little more deeply sedated than typical Level II sedation. P.L. continued breathing on her own and responding to verbal stimuli. During this interval, Dr. Edison was waiting for P.L. to come out of sedation, and he intended to send her home and recommend that she see her doctor about the twitch. Ms. Hoff noticed a second facial twitch between 9:15 a.m. and 9:20 a.m., and Dr. Edison directed Ms. Hoff to call Emergency Medical Services to transport P.L. to the hospital. Ms. Hoff continued to monitor P.L.'s airway, breathing, circulation and vital signs until the Emergency Medical Services team arrived at 9:30 a.m. During this time, Ms. Hoff noted that P.L. responded to verbal stimuli by moving her head a little bit and attempting to open her eyes. P.L.'s oxygen saturation rate was consistently maintained at 99% to 100% between 8:20 a.m. and 9:30 a.m., when Emergency Medical Services arrived. During this time, P.L. was breathing independently and did not need any assistance with her airway. Emergency Medical Services received the call from Dr. Edison's office at 9:21 a.m. and arrived at 9:26 a.m. At that time, P.L. was receiving oxygen, her airway was normal, and her perfusion was good. Her blood pressure was 102/68, her pulse was strong and regular at 120 beats per minute, her respiratory rate was 20, her respiratory effort was normal, and her breath sounds were clear. She was, however, non-responsive: She was not able to open her eyes, she had no motor response, and she was not able to give a verbal response. She appeared to be having seizure activity in the form of twitching on both sides of the jaw line. P.L. was transported to Memorial Regional Hospital at 9:31 a.m., and she arrived at the hospital at 9:36 a.m. A notation on the EMS Report for the incident states that a "[l]ist of sedation medication [was] given to ER staff." Dr. Todd Gardner was the emergency room physician who treated P.L. on her arrival at Memorial Regional Hospital. His diagnosis on admission was status epilepticus and hypoxia. Status epilepticus is seizures that are unrelenting to normal therapeutic intervention, and hypoxia is low oxygen level. Dr. Gardner did not attribute a cause to the status epilepticus. Dr. Gardner's intake notes reflect that, prior to presenting at the emergency room, P.L. had received Ketamine, Labetalol to lower her blood pressure, and Valium to relieve the seizures. Nothing on the intake sheet indicates that P.L. had received Lidocaine, and there is no list of the medications given by Dr. Edison in the hospital file. Dr. Gardner intubated P.L. at 10:02 a.m. and placed her on a ventilator in the emergency room because she was unable to breathe on her own. He also treated her with Valium, Dilantin, and Diprivan, which is used to sedate patients in the intensive care unit. Dr. Robert Alterbaum, an internist specializing in pulmonary medicine and critical care, provided care to P.L. in the intensive care unit of Memorial Regional Hospital. P.L.'s chest X-ray was abnormal and showed pneumonitis, or an inflammation of the lungs, caused by fluid being aspirated into the lungs. Based on the emergency room chart, Dr. Alterbaum diagnosed P.L. with status epilepticus, or seizures, related to the administration of Ketamine during the pre-operative procedure for breast augmentation surgery. There was no objective medical evidence to support Dr. Alterbaum's conclusion that Ketamine was the cause of the seizures; he reached this conclusion because Ketamine was the only medication noted on the chart as having been administered to P.L. Dr. Alterbaum was not aware that P.L. had also received Lidocaine; had he been aware of this, it might have been information he would have considered in reaching his conclusion regarding the cause of P.L.'s seizures.6 P.L. was discharged from Memorial Regional Hospital on July 12, 2005. She had difficulty walking at first, but has fully recovered except that she sometimes experiences a little memory loss. Drugs administered to P.L. Valium Valium is a benzodiazopene used to control anxiety, and the standard dosage ranges from two to 20 milligrams for conscious sedation. Valium is a controlled substance. Ancef Ancef is an antibiotic. Ketamine Ketamine is a disassociative non-barbiturate analgesic used for sedation and general anesthesia; the maximum dosage is 4.5 milligrams per kilogram of body weight. Ketamine causes a large amount of secretions, and its effects last only five to 10 minutes. Ketamine is a controlled substance. Robinol Robinol is an anticholinergic medication used to prevent bradycardia, a heart rate of less than 60 beats per minute, and to help dry out secretions in mucous membranes. Robinol is contraindicated for a patient with tachycardia, or a heart rate of more than 100 beats per minute, however, because it could make the patient's heart rate increase. In a healthy 29 year-old patient such as P.L., however, it was not a violation of the standard of care to administer 0.2 milligrams of Robinol to P.L. even though her heart rate was 104 beats per minute at the time it was administered; a healthy 29-year-old patient could easily sustain a heart rate of 140 beats per minute without ill effects. Dr. Edison administered Robinol to P.L. as a drying agent, to control secretions brought on by the use of Ketamine. Although other drugs can be used to control these secretions, Robinol is the best drug for this purpose and the one most commonly used. Dr. Edison had ample justification for using Robinol under the circumstances, and he did not violate the standard of care by ordering Ms. Hoff to administer the drug even though P.L.'s heart rate slightly exceeded 100 beats per minute. Talwin Talwin is an opiate analgesic that is used to control pain, and the standard dosage is 30 milligrams. Talwin is a controlled substance. Nitrous oxide Nitrous oxide is an anesthetic gas that is used for analgesia and sedation; it was administered to P.L. by nasal cannula, which delivers a relatively small amount of gas. Diprivan Diprivan is a sedative hypnotic medication used both for intravenous sedation and for general anesthesia; the package insert recommends a dosage from 100 to 150 micrograms per kilogram of body weight per minute. Diprivan's clinical effects wear off approximately three minutes after its administration is discontinued. The total dose of Diprivan administered to P.L., 25 milligrams, was included in Dr. Edison's medical records, but the manner of administering the Diprivan and the rate of infusion are not recorded. Diprivan, together with other sedative drugs, may be administered in Florida by a registered nurse at the direction and under the supervision of a surgeon during Level II office surgery.7 Dr. Edison did not deviate from the standard of care in Florida by delegating responsibility to Ms. Hoff, an Advanced Registered Nurse Practitioner, for administering the various drugs to P.L., under his direction and supervision. Based on her training and experience, Ms. Hoff was qualified to administer these drugs to P.L. to achieve Level II sedation under Dr. Edison's direction and supervision. The combination of sedative drugs Dr. Edison ordered administered to P.L., specifically Diprivan, Ketamine, Talwin, Valium, and nitrous oxide, was appropriate to induce Level II sedation in P.L., and the dosage of each of the drugs administered to P.L. was well below the maximum dosage recommended for each of the drugs. These drugs work synergistically, however, and, depending on the patient and the circumstances, the same combination of sedative drugs could induce Level III sedation. Florida Administrative Code Rule 64B8-9.009 defines Level III office surgery and sets forth the standards that must be met, in pertinent part, as follows: Level III Office Surgery. Scope. Level III Office Surgery is that surgery which involves, or reasonable should require, the use of a general anesthesia or major conduction anesthesia and pre- operative sedation. This includes the use of: Intravenous sedation beyond that defined for Level II Office Surgery; General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of pulmonary or cardiac functions: or Major conduction anesthesia. * * * Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following: * * * 4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B8- 30.012(2)(b)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. . . . One difference between Level II and Level III sedation is the degree of alertness of the patient. At Level II sedation, the patient must be able to respond to verbal and/or tactile stimuli. If a patient's only response is a reflexive withdrawal from a pain stimulus, the patient is sedated beyond Level II. A primary indication that a patient has slipped from Level II to Level III sedation is the loss of the ability to breathe without assistance, and the patient's airway must be partially or totally managed. In Level II sedation, the need for management of the airway is minimal compared to that required at Level III sedation. P.L.'s blood pressure, pulse rate, oxygenation, and mental state were consistent with Level II sedation until P.L. had her first seizure and all medications, except for the one- half therapeutic dose of Valium, were discontinued. She remained responsive to verbal stimuli after the second 2.5 milligram dose of Valium was given to control the seizure activity, even though she was more lethargic than normal under Level II sedation. P.L. was non-responsive when examined by Emergency Medical Services personnel, but she was breathing independently and was not at Level III sedation. Her lack of response was more likely than not the result of the seizures, after which a patient can go into a postictal state, or a trance of sleepiness.8 Dr. Edison did not violate the standard of care for office surgery in ordering the amounts and combination of drugs used to sedate P.L. because P.L. did not reach Level III sedation. In accordance with the standard of care for Level II office surgery, Ms. Hoff, as a registered nurse, was qualified to administer anesthesia to P.L., including Diprivan, Ketamine, and the other sedative drugs used in P.L.'s surgery, at the direction and under the supervision of Dr. Edison. Dosage of Lidocaine As stated above, Dr. Edison injected a dilute solution of Lidocaine with epinephrine and marcaine into the tissue around P.L.'s breasts between 8:25 a.m. and 8:45 a.m., before P.L. had her first seizure at 8:45 a.m. Lidocaine is a local anesthetic used to numb nerves and tissue. In breast augmentation surgery Dr. Edison always uses Lidocaine with epinephrine because epinephrine is a vasoconstrictor that causes intense vasoconstriction, or closing of the small blood vessels, which slows the rate of absorption of the Lidocaine and virtually eliminates bleeding at the site of surgery. Marcaine is also a local anesthetic similar to Lidocaine, but it is slow to take effect and lasts four to six hours and helps control pain after surgery is completed. Marcaine is commonly used with Lidocaine. It is Dr. Edison's practice to perform breast augmentation surgery using the tumescent infiltration technique to infuse a relatively large volume of dilute Lidocaine solution into the breast area as a local anesthetic. Dr. Edison uses this tumescent infiltration technique in breast augmentation surgery because he can deliver a large volume of Lidocaine that is evenly distributed throughout the breast area, which results in more effective pain reduction. The injection technique Dr. Edison uses for tumescent infiltration in the breast area is very specific, and it takes between 20 and 30 minutes to complete the injections. The needle cannot penetrate close to the pectoral muscle, especially in a woman as small as P.L., because of the danger of puncturing a lung. Dr. Edison injects the solution under pressure into the subcutaneous tissue between the breast and the pectoral muscle. Lidocaine is absorbed faster in areas that are highly vascular. The tissue in the aerolar space between the breast and the pectoral muscle does not contain many blood vessels, so Lidocaine injected in this tissue is absorbed more slowly than it would be if injected into highly vascular tissue. In Dr. Edison's experience, because the epinephrine in the Lidocaine solution causes intense vasoconstriction in the tissue surrounding the injection sites, the Lidocaine stays in place and numbs the area in which the surgery is to be performed. The Lidocaine solution is absorbed slowly over approximately 24 hours, and the peak serum concentration of Lidocaine occurs approximately 10 to 12 hours after it is administered. In this case, Dr. Edison prepared approximately 400 cubic centimeters of solution, which contained 700 milligrams of Lidocaine and 50 milligrams of marcaine, together with a small, non-therapeutic dose of epinephrine. According to his surgical notes, Dr. Edison began the injections of Lidocaine at 8:25 a.m. and had completed the injections by the time P.L. had the first seizure at 8:45 a.m., although it is his recollection that he had not used all of the Lidocaine solution he had prepared. Dr. Edison did not, however, record in the medical records the amount of Lidocaine solution he injected, and any remaining solution was discarded without being measured, so he does not know the dosage of Lidocaine P.L. actually received. Had he injected all of the solution, P.L. would have received approximately 14 milligrams of Lidocaine per kilogram of body weight. According to the package insert that accompanies a bottle of Lidocaine, the maximum dosage of Lidocaine without epinephrine is five milligrams per kilogram of body weight, and the maximum dosage of Lidocaine with epinephrine is seven milligrams per kilogram of body weight. There is nothing in Dr. Edison's medical records to indicate that the Lidocaine he used in P.L.'s surgery included epinephrine or that he calculated the amount of Lidocaine to administer to P.L. based on her body weight Using the maximum dosage specified on the package insert, the maximum dosage of Lidocaine without epinephrine for P.L. would have been 215 milligrams, and the maximum dosage of Lidocaine with epinephrine would have been 301 milligrams, using the traditional method of administering the drug. Based on the standard established by the package insert, Dr. Edison exceeded the maximum dosage of Lidocaine with epinephrine injected into P.L. by approximately 400 milligrams, which constituted a toxic dose of Lidocaine when measured by the maximum dosage stated on the package insert. The maximum dosage of Lidocaine with epinephrine stated on the package insert is routinely exceeded by surgeons performing liposuction, which involves suctioning fatty tissue. The tumescent infiltration technique using Lidocaine with epinephrine in a dilute solution is commonly used with liposuction, and Florida Administrative Code Rule 64B8- 9.009(2)(d), which sets out the standards of care for office surgery, specifically provides that a "maximum of fifty (50) mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting." Large dosages of Lidocaine can be safely used in liposuction because Lidocaine is metabolized more slowly by fatty tissue than by muscle or skin, and approximately 20% of the Lidocaine solution is suctioned out of the body with the fat that is aspirated during liposuction. As a result, it is possible to administer what would otherwise be toxic doses of Lidocaine under the maximum dosages specified in the package insert. Dr. Edison has used the tumescent infiltration technique many times in performing breast augmentations without his patients' suffering any ill effects. There is, however, no rule in Florida equivalent to that relating to liposuction that permits the use of high dosages of Lidocaine as local anesthetic in breast augmentation surgery. Furthermore, Dr. Edison has failed to submit persuasive evidence of a standard of care in Florida among plastic surgeons that would permit the use of dosages of Lidocaine with epinephrine in excess of the seven milligrams per kilogram specified on the package insert for breast augmentation surgery.9 Dr. Edison violated the standard of care by injecting approximately of 700 milligrams of Lidocaine with epinephrine into the tissue surrounding P.L.'s breasts when the maximum allowable dosage, according to the insert packaged with the drug and based on P.L.'s weight, was approximately 300 milligrams. Dr. Edison's previous discipline10 Dr. Edison was charged in an Administrative Complaint dated February 21, 1995, with having committed medical malpractice in violation of Section 458.331(1)(t), Florida Statutes. He executed a Consent Agreement in which he neither admitted nor denied the factual allegations in the complaint but agreed that, if proven, the facts would constitute a violation of Section 458.331(1)(t), Florida Statutes. The Agency for Health Care Administration entered a Final Order dated August 20, 1995, adopting the Consent Agreement in relevant part. This Final Order does not establish that Dr. Edison committed a violation of Section 458.331(1)(t), Florida Statutes. In a Final Order entered January 4, 2007, the Board adopted the recommended disposition in the Recommended Order in Department of Health, Board of Medicine v. Richard B. Edison, M.D., DOAH Case No. 06-0598PL (Recommended Order August 25, 2006), that Dr. Edison be found guilty of a single violation of Section 458.331(1)(m), Florida Statutes.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order Dismissing Counts Three and Four of the Administrative Complaint; Finding Dr. Edison guilty of a single violation of Section 458.331(1)(m), Florida Statutes, and of two violations of Section 458.331(1)(t)1., Florida Statutes; Suspending Dr. Edison's license for a period of 90 days, followed by four years' probation under such terms as shall be imposed by the Board; and Imposing an administrative fine in the amount of $15,000.00. DONE AND ENTERED this 1st day of May, 2007, in Tallahassee, Leon County, Florida. S PATRICIA M. HART Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of May, 2007.
