The Issue This case arises out of a petition filed by Humana, Inc., Humedicenters, Inc., and Humhosco, Inc., challenging the validity of Respondent's Rule 10- 5.11(23), Florida Administrative Code. The challenged rule was promulgated by the Department of Health and Rehabilitative Services to provide a uniform methodology for determining the need for acute care beds in the various IRS districts in Florida. Subsequent to the filing of the petition and the scheduling of this matter for hearing, the Intervenor, University Community Hospital, filed a petition to Intervene and was permitted to intervene upon the same issues raised by the original petition. At the formal hearing, the Petitioners Humana, Inc., Humedicenters, Inc., and Humhosco, Inc., called as witnesses Brad Sexauer, David Petersen, Ira Korman, Richard Alan Baehr, Frank Sloan and James Bruce Ryan. Petitioners offered and had admitted into evidence nine exhibits. The Intervenor, University Community Hospital, called as witnesses Warren Dacus and George Britton. The Intervenor offered and had admitted into evidence three exhibits. The Respondent, the Department of Health and Rehabilitative Services, called as witnesses Stanley K. Smith, Stephen Williams and Phillip C. Rond. The Department offered and had admitted into evidence 36 exhibits. Respondent's Exhibits 5, 6, 14, 15, 16 and 17 were not admitted for all purposes but were admitted as hearsay for the purpose of corroborating or explaining other admissible evidence in the record. Counsel for each of the parties submitted proposed findings of fact and conclusions of law for consideration by the Hearing Officer. To the extent that those proposed findings of fact and conclusions of law are inconsistent with this order, they were rejected as not being supported by the evidence or as unnecessary to the resolution of this cause.
Findings Of Fact STANDING The Petitioners and Intervenor are corporations engaged in the business of constructing and operating hospitals in the State of Florida. Humedicenters, Inc. and Humhosco, Inc., are wholly owned subsidiaries of Humana, Inc. Humana, Inc., and its corporate subsidiaries presently have seven (7) pending applications for Certificates of Need for acute care hospital facilities. At least one of those applications for a facility in Jacksonville, Florida, was denied by HRS on the basis that no need existed under the challenged rule methodology. The Intervenor, University Community Hospital, is located in HRS Service District 6A in northern Hillsborough County. On June 29, 1982, University Community Hospital applied for a Certificate of Need for additional medical surgical beds and on December 1, 1982, HRS denied that application. HRS has taken the position that the challenged rule is applicable to that application and under the rule, there is no need for additional medical-surgical beds in District 6. DEVELOPMENT OF THE RULE As early as 1976, the Department began its effort to identify alternative approaches to acute care bed need determinations and at that time, the Department contracted with a consultant to review and assess various bed need approaches. An analysis was made of the then current methods or models used for projecting short-term bed requirements. This analysis was provided to a Bed Need Task Force which had been formed to consider appropriate bed-need methodologies. In early 1977, the Bed Need Task Force was appointed to review current bed-need methodologies and to recommend necessary changes to the methodologies in use. The Bed Need Task Force was formed for the primary purpose of recommending a general approach to be used in bed need determinations and to identify key policies to be followed in development of an acute care methodology for the State of Florida. This task force was composed of a variety of representatives from various groups including local planning agencies, hospital associations, the statewide health council, and the health industry itself. An outside consultant was used by the Task Force to aid them in their review. In February 1978, the Final Report of the Bed Need Task Force was issued. Subsequent to the Bed Need Task Force, the Task Force on Institutional Needs, (hereafter TFIN) was established. The purpose of the TFIN was to present a recommended methodology and policies related to that methodology for purposes of the initiation of implementation activities. The TFIN issued its final report in December 1978. This report contained a number of policies to be used in conjunction with the methodology. These policies stated that: The population composition should not include tourists but should include seasonal residents who reside in Florida greater than six months and these migrants who were in Florida on April 1, the date of each census. The methodology should deal with the differences in need for acute care services by age and sex. The use rates utilized should be based on a statewide normative standard. These standards should be based on statewide use rates for which data can be obtained and should be subject to periodic review. Methodology should eventually address need for various levels of care. Need determinations should be for specific geographical areas, the area of the Health Systems Agency (hereafter HSA). These areas are new the HRS districts. Patient flows should be taken into account but should not be binding on future determination in terms of expansion or addition of new facilities. The hospital service area concept should be rejected and a temporal accessibility criterion utilized. At the HSA level, a minimum volume standard should be developed for each service. The standards within the methodology should be applied uniformly all over the state in all HRS districts or service areas. The standards should not be applied to individual facilities. In terms of role and responsibility, the Department of HRS should be responsible for the need methodology with the local health agencies having responsibility for the facilities configuration model for its district. Having developed a recommended methodology and a set of policies to be used in conjunction with that methodology, the Department contracted with Research Triangle Institute (RTI) to develop a sampling design to be used in the data collection activity so that the methodology could be operationalized. A second contract was let to implement the data collection necessary to the methodology and to develop statewide estimates based on the data collected. The 1978, 1979, 1980, and 1981 State Health Plans each discussed the objective of achieving a certain ratio of nonfederal licensed acute care beds per 1,000 population in Florida. The 1981 State Health Plan adopted a goal to ensure a supply of licensed nonfederal, short-stay beds (including psychiatric beds) in Florida equivalent to 4.24 beds per 1,000 residents. Also, in 1981, the State Health Council adopted a "normative" bed-to-population ratio of 4.24 beds per 1,000 population. "Normative" means a statement of what "ought to be" as opposed to some historical standard. In the Spring of 1982, HRS actually began drafting the rule and in the September 3, 1982, issue of the Florida Administrative Weekly, HRS gave notice of its intent to adopt Rule 10-5.11(23) relating to acute care hospital beds. That notice also set a time, date and place for a public hearing on that proposed rule. Before a public hearing on that proposed rule was held, however, Petitioners Humana of Florida, Inc., Humedicenters, Inc., and Humhosco, Inc., and others, challenged it in D.O.A.H. Case 82-2561R. The intervenor in this proceeding was also an intervenor in that challenge. A public hearing on that initial rule was held September 20, 1982. Neither the Petitioner nor the Intervenor made any statement at the public hearing in opposition to the rule or in opposition to the expected economic impact. No written comment was submitted by these two parties following the public hearing. At the public hearing, there were eight oral presentations made by interested parties and 14 written comments were received. From the time the initial rule was promulgated until the time it was finally adopted, there were numerous other comments that were received. Two sets of changes were subsequently made to the proposed rule which reflected discussion and input the Department received both from the public hearing process and from challenges to the rule. The first set of changes was published April 1, 1983 in the Florida Administrative Weekly. Several issues were raised which were dealt with by the Department. Psychiatric bed need was removed and placed in a separate rule, the methodology was incorporated into the rule, language regarding the use of the formula was clarified, data updating provisions were added, a provision was made to consider peak demand, the district utilization adjustment procedure was changed and subdistrict bed allocation procedures were changed. Although there was also objection to the use of statewide use rates, the Department because of strong policy considerations, made no change in the statewide use rates. These changes were made in response to the comments at the public hearing, written comments submitted, and other input from the health industry. After the Department published its first set of changes to the initial rule, but before the publication of the second set of changes, Petitioners voluntarily dismissed their rule challenge in D.O.A.H. Case No. 82-2561R. The second set of changes was published in the Florida Administrative Weekly on May 13, 1983. At the time of their voluntary dismissal of their rule challenge and prior to the adoption of the challenged rule, Humana, Inc., and its subsidiaries, Humedicenters, Inc. and Humhosco, Inc. were aware of the economic impact the proposed rule would have on their operations in Florida. THE RULE Rule 10-5.11(23), Florida Administrative Code, is founded on a basic methodological approach to projecting the need for health care services which is commonly accepted and utilized among health planners. In its most generic form, this methodological approach may be expressed as follows: The population of the geographic planning unit is projected for some point in the future (usually five years); i.e., how many people will live in the planning area at the end of five years. The projected population is multiplied by a utilization rate in order to project how many days of hospital care the projected population is likely to need during the target year. A utilization rate is the measure by which hospital services are consumed within a given geographic entity and is determined by dividing the total number of hospital patient days in a year in a given area by the total population of that area for that year. Restated, a utilization rate is equivalent to the ratio of the number of days of care received by the population to the population as a whole. As noted above, multiplying a projected population by a utilization rate produces the projected number of-patient days during the target year. This number is then divided by 365 to derive an average daily census i.e., the average number of patients which one would expect to be in area hospitals on any given day of the year. The average daily census is then converted into beds by dividing the average daily census by an optimal occupancy standard for a given service. The optimal occupancy standard contemplates that hospitals cannot and should not operate at 100 percent occupancy in that some reserve capacity is necessary to meet seasonal or even weekly fluctuations and variations in patient characteristics and mix. The product of this generic methodology is the total number of beds needed in the planning area at the end of the planning horizon. Application of the methodology set forth in the rule is basically a three-step process. The initial step is the forecast of the District Bed Allocation (DBA), which is accomplished as follows: The population of each Department service district is forecast by age cohort (a cohort is a given subgroup of the total population) five years into the future. The age cohorts utilized in the rule are: (1) under 65; (2) 65 and older; (3) under 15; and (4) females 15-44. Total patient days are then forecast for each age cohort. Patient days are forecast by applying statewide, service-specific discharge rates and average lengths of stay to the age cohort projections. The specific hospital services included in the Rule are medical/surgical, intensive care, coronary care, obstetrical and pediatric. Projected patient days for persons age 65 and older are adjusted to account for the migration flew of elderly patients both to and from Florida and to and from Department districts within Florida. This flew adjustment is based upon historical migration patterns derived from 1977 Medicare data. The service-specific patient days by age cohort is then converted to projected bed need by dividing each component by 365 to arrive at an average daily census and then by applying a service-specific occupancy standard to derive the total bed need for each given service and age cohort. The sum of the bed need forecasts for each service/cohort is the DBA. The second step is an adjustment to the DBA under certain circumstances based on the projected occupancy of the beds allocated to a given district. This is known as the Adjusted District Bed Allocation (ADBA), and it is composed of the following steps: A Projected Occupancy Rate (FOR) for each district is calculated by multiplying the entire forecast population of the district by a Historic Utilization Rate (HUR), which is derived over the most recent three year period. The product is then divided by 365 times the DBA. The product of this computation is the POR which would result if the district contained the number of beds projected by the DBA and the population continued to utilize hospital services in accordance with the HUR. If the POR is less than 75 percent, the ADBA is determined by substituting a 90 percent occupancy standard in the formulation of DBA instead of the service-specific occupancy standards which would otherwise be applied (ranging from 65 percent for obstetrics to 80 percent for medical/surgical). If the POR is greater than 90 percent, the ADBA is determined by substituting a 75 percent occupancy standard in the calculation of DBA instead of such service- specific standards. In other words, when the POR is less than 75 percent, a a downward bed need adjustment results. When POR is greater than 90 percent, an upward need adjustment results. This part of the methodology is used to make an adjustment for those districts which for whatever reason lie outside the range of-expected utilization. The 75 percent and 90 percent thresholds are based upon an ideal operating range of 80 to 85 percent. The actual standard utilized by HRS is 80 percent, at the low or conservative end of that range. The third step involves the calculation of a Peak Demand Adjustment (PDA) which is accomplished as fellows: The average daily census for a given district is calculated by dividing the total number of projected days by 365. Peak demand is calculated by adding the average daily census to the square root of tic average daily census multiplied by a given standard deviation (1.65 for low peak demand districts or 2.33 for high peak demand districts) referred to as a "Z" value in the methodology: Peak demands utilized as the projected district acute care bed need if it is greater than the bed need for the district reflected by DBA or ADBA as calculated in steps one and two above. The purpose of this peak demand adjustment is to ensure that each district will have sufficient bed capacity to meet service-specific peak demands. Each subdistrict is to be identified by the Local Health Council as having high or low peak demand. These designated as high peak demand utilize a "Z" value; of 2.33 in the methodology in order to assure sufficient capacity to meet 99 percent of their peak capacity. These subdistricts designated as low peak demand areas utilize a "Z" value in the methodology of 1.65 and this assures sufficient total bed capacity to meet 95 percent of the peak demand. The rule also includes an accessibility standard which provides that in each district acute care hospital beds should be available and accessible to 90 percent of the residents within 30 minutes driving time and 45 minutes driving time in urban and rural areas respectively. The rule provides for periodic updating of the statewide discharge rates, average lengths of stay and patient flow factors as data becomes available. The historical use rate used in arriving at the adjusted district bed allocation is updated annually through the use of the most recent three years. Although the rule provides that a Certificate of Need will not "normally" be granted unless need is shown to exist under the methodology in the rule, this need calculation is not determinative of the issue of whether a Certificate of Need should be granted. The rule also provides that even if no bed need is shown to exist under the methodology a Certificate of Need may still be granted if the criteria, other than bed need, under Section 381.494(6)(c), Florida Statutes, demonstrate need. Likewise, the rule states that a Certificate of Need may be denied, where bed need is shown to exist under the rule, but other criteria in Section 381.494(6) are not met. The rule also specifically permits the approval of additional beds in a subdistrict where the accessibility requirements of the rule are not being met. Additional beds may also be approved where there is a need in a subdistrict but a surplus in the district as a whole. The rule utilizes population projections by age cohort in determining the number of hospital patient days by service which will be needed five years in the future. These population projections are based upon the projections made by the Bureau of Economic and Business Research (hereafter BEBR) at the University of Florida. BEBR makes three projections--low, midrange, and high-- for each year. The rule utilizes the midrange projection and the inherent margin of error in these projections is typically plus or minus 5 percent. Although these projections have systematically been low in the past, BEBR now uses a different method which utilizes six different techniques in arriving at ten projections which are then averaged. The flow adjustment used in arriving at the DBA is based upon 1977 MEDPAR data. This data was for Medicare recipients 65 years of age and elder and therefore the flow adjustment is only for that portion of the population over 65 years of age. No data was available from which flow factors could be determined for age cohorts or groups from o to 64 years of age. No data for either age group was available after 1977. ECONOMIC IMPACT STATEMENT An economic impact statement (EIS) was prepared for the challenged rule. The EIS contains an estimate of the Department's printing and distribution cost. The EIS was-- prepared by Phillip Rond, an employee of the Department of Health and Rehabilitative Services. In preparing the EIS, Mr. Rond did a comparison of the health system plans (HSP) with the results under the rule. This comparison was for projected need for the year 1987 and was done for each HRS District. The comparison generated the following results: HRS DISTRICT HSP RULE 1 0 0 2 3 0 3 0 0 4 0 0 5 0 0 6 0 0 7 0 0 8 0 87 9 0 137 10 0 0 11 0 0 3 224 The need calculations under the rule do not change substantially the short term projections under prior methodologies. The rule calculations for 1987 showed need for 221 more beds than was shown to exist under the methodologies used in the health systems plans. Mr. Rond also reviewed the background literature that led to the analysis contained in the state health plan as well as the reports from the Hospital Cost Containment Board. With regard to the rule's affect on competition and the open market the EIS notes that the rule will restrain the development of costly excess acute care bed capacity and in doing so will foster cost containment. Where need is indicated by the methodology or other criteria within the rule then competitive new beds will be allowed. In terms of economic benefit to persons directly affected the EIS points out that there will be a positive impact for some facilities and a negative impact for others. The rule will negatively impact facilities which wish to expand or add new beds if no need for those beds exists under the methodology of the rule. Existing facilities, however, will not be exposed to expansion of the bed supply in those districts where no need for additional beds exist. This benefit will be particularly positive for those facilities providing indigent care. It is a general estimate that operating costs for a health facility will be approximately 22 cents for each dollar of capital expenditure. The rule is intended to support a supply of beds to meet need while preventing excess or unused beds, thus reducing annual operating costs. The EIS notes that by reducing operating costs, the operating cost per bed will be lower and should result in a slower escalation of costs to consumers as well as third party payers such as insurers, taxpayers, and employers. Prior to adoption of the challenged rule, the Department considered and evaluated each of the factors listed in Section 120.54(2), Florida Statutes. There has been traditionally in Florida a surplus of acute care beds. The 1977 medical facilities plan indicated a surplus of beds ever need of 7,253 beds. Using the rule methodology and projecting to 1987, there is a surplus ? 5,562 beds and for 1988, a surplus of 4,044 beds. In both 1980 and 1982, there were significant numbers of licensed beds in the state which were not in use. In 1980, there were 4,923 beds out of the total bed stock in acute care hospitals not in use. This was about 10.7 percent of the total licensed in bed stock. In 1982, there were 5,093 or about 10.6 percent of such beds licensed and not in use. In 1976, the occupancy rate for acute care hospitals in Florida was 60.3 percent. In 1982, the occupancy rate in such facilities was 67 percent. The target occupancy rate under the challenged rule and its methodology is 80 percent.
The Issue Whether Respondent violated Subsections 458.331(1)(m) and 458.331(1)(t), Florida Statutes, and, if so, what discipline should be imposed.
Findings Of Fact The Department is the State agency charged with regulating the practice of medicine pursuant to Section 20.43 and Chapters 456 and 458, Florida Statutes. At all times material to this proceeding, Dr. Mationg was a licensed physician in the State of Florida. His license, numbered ME 0028183, was issued on April 13, 1976. Dr. Mationg is the primary care physician of A.A. Dr. Mationg referred A.A. to Dr. Steven Schafer, an orthopedic surgeon, for pain in the right shoulder, which was found to require arthroscopic surgery and repair of a rotator cuff. On January 10, 2000, A.A. was admitted to Regional Medical Center Bayonet Point (Bayonet Point) for surgery. At the time of his admission to the hospital, A.A. was 65 years old and suffered from numerous medical problems. He had cardiomyopathy, meaning his heart was enlarged and not functioning properly. A.A. had high blood pressure and a history of heavy smoking. He had generalized arteriosclerosis and peripheral artery disease. A.A. had previously had surgeries involving the placement of a stint and angioplasty. Based on his medical history, A.A. was subject to a stroke and a heart attack. Prior to his admission to the hospital, A.A. had been taking aspirin daily. Approximately three days prior to surgery, A.A. was directed by Dr. Schafer to discontinue taking aspirin. The aspirin was discontinued to reduce the risk of A.A.'s blood not being able to clot sufficiently. The hospital records of A.A. contain a request for consultation with Dr. Mationg for medical management dated January 10, 2000. The discharge summary shows that the medical evaluation was obtained so that A.A. could be followed by his primary care physician for his hypertension and other medical history. Dr. Schafer performed the surgical procedure on A.A. on January 10, 2000. A.A. had some respiratory problems, and Dr. Mationg ordered a pulmonary consultation with Dr. Patel the afternoon of January 10, 2000. Because of the respiratory problems, A.A. was placed on a ventilator and transferred to the intensive care unit. On January 11, 2000, Dr. Patel extubated A.A., which means that A.A. was taken off the ventilator. On January 11, 2000, Dr. Mationg saw A.A. at 9:00 a.m. and wrote and signed an order for lasix and lanoxin for A.A. Around 3:15 a.m. on January 12, 2000, A.A. was awakened for respiratory therapy and experienced numbness in his left arm and slurring of speech. When A.A. smiled, the left side of his mouth remained flat while the right side turned up. The nurse on duty was called, and he observed A.A.'s symptoms. A.A.'s symptoms indicated that he was having a stroke. Nurse Culligan notified Drs. Schafer and Mationg. Dr. Mationg did not come to the hospital to evaluate A.A. The standard of care would have required him to come to the hospital to evaluate A.A. because A.A. was exhibiting the symptoms of a stroke. Instead of coming to the hospital to do an evaluation, Dr. Mationg gave the following orders telephonically to Nurse Culligan at 4 a.m., on January 12, 2000: T.O. Dr. Mationg/M. Culligan do CT head [without] contrast today a.m. do carotid doppler study today a.m. consult Dr. S. Shah for neuro eval. get speech therapy eval. and video swallow today. Nurse Culligan wrote the orders on A.A.'s chart; Dr. Mationg later countersigned the orders. The term "stat" in medical parlance means immediately or as soon as possible. An order is not presumed to be stat if the order does not specify that it is stat. The tests and consultation which Dr. Mationg ordered at 4 a.m., on January 12, 2000, were not ordered to be implemented stat. The standard of care for treating A.A. required that Dr. Mationg order a stat neurological consultation and a stat head CT scan. Bayonet Point has established policies for its imaging services department, including CT services. The normal hours for CT services are 7 a.m. to 11 p.m., Monday through Sunday. After normal hours, the services are provided on-call. Bayonet Point's call-back procedures include the following: When an emergent radiologic procedure is ordered after hours, the Radiology personnel will contact the appropriate on call technologist via the hospital operator. Once the procedure is complete, the Technologist will call the Radiologist on call and then transmit those images via Teleradiography. Definition of an emergent procedure: In- house STAT, Emergency Department physician requesting radiologist interpretation, any outpatient whose physician requests immediate radiologist interpretation or "wet reading." Prior to A.A.'s experiencing the symptoms of a stroke at 3:15 a.m., no orders had been given for A.A. to resume taking aspirin. At 10 p.m. on January 10, 2000, Dr. Schafer ordered that "till further notified" all medications taken by mouth which could be taken intravenously were to be administered via an IV. Aspirin could not be administered intravenously. Because Dr. Schafer had ordered that aspirin therapy be stopped prior to surgery, it would be the responsibility of Dr. Schafer to order the aspirin to be restarted. Dr. Schafer was at A.A.'s bedside at 8:30 a.m., on January 12, 2000. Dr. Schafer noted that a head CT scan was ordered for that morning and that the patient was on his way down for the test. Dr. Schafer also noted that a neurological evaluation had been ordered for A.A. for that morning. The hospital records show that at 8:50 a.m., on January 12, 2000, a call was made to Dr. Shah's answering service, requesting a neurological consultation. The request for consultation form, which was filled out after Dr. Schafer's visit at 8:30 a.m., indicated that the request was an emergency request. The request for consultation form was filled out by someone other than the nurse who charted Dr. Mationg's verbal order for a neurological consultation. Based on the evidence presented, the request for a neurological consultation was not treated as an emergency request until after Dr. Schafer saw A.A. at 8:30 a.m. Tissue Plaminogen Activators (TPA) are used to dissolve clots which may be causing a stroke. The use of TPA is limited to a three-hour window following the onset of stroke symptoms. Dr. Mationg did consider the use of TPA, but felt that it was contraindicated based on the recent surgery. This opinion was confirmed at final hearing by a neurologist.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding that Dr. Mationg violated Subsection 458.331(1)(t), Florida Statutes; finding that Dr. Mationg did not violate Subsection 458.331(1)(m), Florida Statutes; placing Dr. Mationg on two years probation; imposing an administrative fine of $5,000; and requiring that Dr. Mationg attend ten hours of continuing medical education courses in the diagnosis and treatment of strokes and four hours of continuing medical education courses in risk management. DONE AND ENTERED this 3rd day of July, 2003, in Tallahassee, Leon County, Florida. S ___________________________________ SUSAN B. KIRKLAND Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of July, 2003. COPIES FURNISHED: James W. Earl, Esquire Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 A. S. Weekley, Jr., Esquire Holland & Knight, LLP 400 North Ashley Drive, Suite 2300 Tampa, Florida 33602 Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701
The Issue Did Mary Moshier violate Section 464.21(1)(b) , Florida Statutes, as alleged in the Administrative Complaint?
Recommendation It is noted as a fact in mitigation that Moshier was suspended for 21 days by the hospital where she worked for the incidents that gave rise to this Administrative Complaint. Based upon the foregoing Findings of Fact and Conclusions of Law, and considering the facts in mitigation, the Hearing Officer recommends that Mary Moshier be placed on probation for a period of six months for the violation of Section 464.10(1)(f) , Florida Statutes, by using profane language regarding a patient in the vicinity of the patient. DONE and ORDERED this day of May, 1980, in Tallahassee, Leon County, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire 1107 Blackstone Building 233 East Bay Street Jacksonville, Florida 32202 Joseph S. Farley, Jr., Esquire 350 East Adams Street Jacksonville, Florida 32202 Geraldine B. Johnson, R. N. Beard of Nursing 111 Coastline Drive East, Suite 504 Jacksonville, Florida 32202
Conclusions Competent substantial evidence supports the conclusion that Adrian Fuentes disabilities are the result of the failure to deliver him before his mother loss amniotic fluid, or up to an estimated 12 hours earlier. An earlier delivery was the standard of care expected in a case of IUGR. His permanent and severe disabilities were directly and proximately caused by the failure of SBHD employees to handle an ultrasound report expeditiously as directed and as their policy provided. ATTORNEYS’ FEES AND LOBBYISTS’ FEES: In compliance with s. 768.28(8), F.S., but not with Section 3 of this claim bill, Claimant's attorneys' fees are set at 25 percent. There is no lobbyist for the bill at this time. As of October 9, 2007, the attorneys reported having incurred costs of $115,246.02 for representing the Claimant. The Claimants entered into an agreement to pay attorneys’ fees and costs. RECOMMENDATIONS: For the reasons set forth in this report, I recommend that Senate Bill 60 (2008) be reported FAVORABLY. Respectfully submitted, Eleanor M. Hunter Senate Special Master cc: Senator Jeremy Ring Representative Evan Jenne Faye Blanton, Secretary of the Senate House Committee on Constitution and Civil Law Tom Thomas, House Special Master Counsel of Record
The Issue DOAH Case No. 01-3148: Whether the Respondent's licensure status should be reduced from standard to conditional. DOAH Case No. 01-4649: Whether the Respondent committed the violations alleged in the Administrative Complaint dated October 15, 2001, 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: AHCA is the state agency responsible for licensing and regulating the operation of nursing home facilities, including ensuring that nursing homes are in compliance with criteria established by Florida statute. Chapter 400, Part II, Florida Statutes (2001). AHCA is authorized in Section 400.23(8), Florida Statutes, to impose administrative fines on nursing home facilities that fail to meet the applicable criteria. Florence Treakle conducted surveys of Life Care on May 9, 2001, and June 12, 2001, as a result of complaints received by AHCA. Because the surveys were conducted as a result of complaints received by AHCA, Ms. Treakle was the only AHCA surveyor conducting the surveys. The results of the surveys were reported on a form identified as "HCFA-2567," which is generated by the federal Department of Health and Human Services, Health Care Financing Administration, and is commonly referred to as a "Form 2567." Several deficiencies were identified in the Form 2567s completed for the May 9, 2001, and June 12, 2001, surveys, which were each cited to a federal "tag number" designated as "F" tags,1 to the applicable provision of the Code of Federal Regulations, and to the applicable Florida administrative rule. Each deficiency was also classified under Florida law as either a Class II or a Class III deficiency, and a factual narrative was included to support each deficiency cited. May 9, 2001, survey.2 The Form 2567 for the May 9, 2001, survey included a citation for a Class III deficiency under F-279, "Resident Assessment," and Section 483.13(c), Code of Federal Regulations. This citation involved the care provided to residents L.D. and A.M. and was supported by the assertion that, "[b]ased on observation and record review[,] . . . the facility did not have comprehensive care plans in place for healing of the residents [sic] pressure sores." A care plan is a tool used by the nursing staff to ensure that the resident is getting consistent care and is compiled from data included in a resident's Comprehensive Assessment. An entry in a care plan includes the identification of a problem, a goal for resolving or improving the problem, and the approaches, or means, to be used to reach the goal. Resident L.D. L.D. came into Life Care with pressure ulcers, including a Stage IV pressure ulcer3 on his coccyx, which is located at the bottom of the backbone. L.D. was receiving wound care both at Life Care and at a wound care center pursuant to a physician's order dated April 4, 2001, which contained the following requirement: "[O]ffload[] all boni [sic] prominences as much as possible." In accordance with this order, L.D. was turned and repositioned in bed every two hours, and he was provided with a special, pressure-relieving mattress. L.D. was a very quiet person, but he had no cognitive impairment and was able to communicate his needs to staff. L.D.'s wife visited him every day; she usually arrived in mid-morning and left in mid-afternoon, and she returned for a few hours in the evening. Both L.D. and his wife made it clear to the Life Care staff that L.D. wanted to sit in a wheelchair as much as possible so that he could move around the facility, take walks outdoors with his wife, and have his meals sitting up. L.D. used a special, high-backed wheelchair that he provided for his use while he was a resident of Life Care. The chair reclined so that pressure on his coccyx could be relieved somewhat, and Life Care furnished him a gel cushion for his wheelchair, also to help relieve pressure on his coccyx. On May 9, 2001, Ms. Treakle observed L.D. sitting in his wheelchair for over two hours, from 10:20 a.m. until 1:00 p.m. She found nothing in L.D.'s Care Plan regarding the amount of time L.D. would be permitted to sit in a wheelchair. Resident A.M. A.M. entered Life Care with a Stage III pressure ulcer on his left buttock. A.M. was receiving wound care at Life Care in accordance with the approaches included in his Care Plan. A.M. was not cognitively impaired, and he could communicate his needs to staff. His granddaughter and one year-old great-grandson visited him every day, and he enjoyed sitting outside in a wheelchair with his great-grandson on his lap. A.M. also liked to spend most of his time outside his room, moving himself around the facility in a wheelchair. Life Care provided a gel cushion for his wheelchair to help relieve pressure on A.M.'s buttock. On May 9, 2001, Ms. Treakle observed A.M. sitting in a wheelchair from 2:00 p.m. until 3:30 p.m. A.M.'s Care Plan did not contain an entry establishing the amount of time A.M. would be permitted to sit in a wheelchair. Summary. AHCA has failed to establish by even the greater weight of the evidence that the Care Plans developed for L.D. and A.M. were deficient. AHCA failed to present credible evidence of the contents of L.D.'s Care Plan,4 but the evidence is uncontroverted that L.D.'s wound care orders contained approaches for healing his pressure sores. A.M.'s Care Plan included several approaches for healing his pressure sores, and AHCA has not alleged that the required wound care was not provided to either L.D. or A.M. Rather, AHCA's specific complaint regarding the Care Plans of L.D. and A.M. is that there was no approach specifying the amount of time L.D. and A.M. would be permitted to sit in their wheelchairs. This complaint is based exclusively on the expectations of Ms. Treakle. Ms. Treakle expected to find this approach in the Care Plans because, in her opinion, pressure on the coccyx and buttocks can never be completely relieved when a resident is sitting,5 and any pressure on a pressure ulcer impedes healing because it decreases blood flow to an area. Accordingly, Ms. Treakle "would expect good practice would [sic] be for the Care Plan to indicate how long the resident was going to sit on this pressure sore."6 AHCA did not, however, submit any evidence of a standard of care requiring that the duration of time a resident can sit in a wheelchair be included as an approach in the care plan of a resident with a pressure ulcer, especially when the resident is alert, mobile, and able to communicate with staff. June 12, 2001, survey. The Form 2567 for the June 12, 2001, survey cited Life Care for three deficiencies: A Class II deficiency was cited under F-224, "Staff Treatment of Residents," and Section 483.13(c)(1)(i), Code of Federal Regulations, involving the care provided to residents E.G. and N.D. and supported by the assertion that "[b]ased on observation, record review and interview[,] the facility did not monitor and supervise the delivery of care and services." A Class III deficiency was cited under F-279, "Resident Assessment," and Section 483.20(k), Code of Federal Regulations, supported by the assertion that, "[b]ased on review of the care plan for resident #1 [N.D.], . . . the facility did not complete a comprehensive care plan that was revised to reflect all fall risks." A Class II deficiency was cited under F-281, "Resident Assessment," and Section 483.20(k)(3)(i), Code of Federal Regulations, supported by the assertion that, "[b]ased on citations at F 224[,] F 279 and F 324[,] the facility nursing staff did not provide care that met professional standards for residents #1 [N.D.] and #2 [E.G.]." Resident E.G. Diabetes management. Pertinent to these proceedings, E.G. was diagnosed with insulin-dependent diabetes; his blood sugar generally ranged from 150 to 270, which is in the mid-range, although it once reached 348. E.G. was alert, oriented, self-ambulatory, and somewhat grouchy. E.G.'s brother visited him about three times each week, and E.G. often left the facility with his brother for a meal. He did not adhere strictly to his diet, but often ate fried foods when he went out with his brother, and he kept a supply of orange juice in the small refrigerator in his room. Both fried foods and orange juice are contraindicated for diabetics. Pursuant to physician's orders, E.G.'s blood sugar was to be monitored four times a day, before each meal and at bedtime,7 and insulin was to be administered on a sliding scale, in an amount to be determined based on his blood sugar level. This order was transcribed on E.G.'s Medication Record, which, for each day of the month, included spaces for the time, the blood sugar level, the insulin coverage (the dosage expressed in number of units administered), and the site of injection, together with the initials of the staff member providing the care. Life Care staff also maintained glucose monitoring sheets, which included spaces for the date, the time, the blood sugar level, the dosage of insulin administered, and the initials of the staff member providing the care. There is no documentation in E.G.'s Medication Records, his glucose monitoring sheets, or the Nurses Notes that his blood sugar was checked at 11:30 a.m. on June 7, 2001. When his blood sugar was checked at 4:30 p.m. on June 7, it was 317, which is substantially higher than usual. For the 6:30 a.m. checks on June 2, 3, and 8, 2001, E.G.'s blood sugar level was documented and there are notations that insulin was given, but the dosages and sites of injection were not noted; E.G.'s blood sugar at the 11:30 a.m. checks on these days was either virtually the same as, or less than, the levels noted at the 6:30 a.m. checks. For the 6:30 a.m. check on June 4, 2001, E.G.'s blood sugar level was documented, but there is no notation that insulin was given; E.G.'s blood sugar at the 11:30 a.m. check on June 4 was less than the level noted at the 6:30 a.m. check. Wound Care. On June 5, 2001, a dermatologist removed a lesion from the top of E.G.'s left hand. The dermatologist prescribed Bactroban ointment, which was to be applied to the wound twice a day. Wound care instructions were included with the prescription, which provided as follows: Leave bandage on for 24 hours only without getting wet. Remove bandage after 24 hours and then do not apply another bandage. Leave the area open and clean the wound twice daily with warm water. Pat the wound dry and then apply Bactroban Ointment. Bactroban Ointment is a topical antibiotic that can be purchased without a prescription. Continue to do this until the wound has healed. Normal bathing can be resumed after the bandage is removed. Some redness and swelling are normal in the immediate area of the wound. If the wound develops significant redness, tenderness or a yellow drainage, please contact this office immediately . . . . A physician's order dated June 5, 2001, was written for E.G. for "Bactroban oint to wound on L hand, 45gm." The order did not state how often the ointment was to be applied or include the other instructions accompanying the prescription. The order was transcribed on E.G.'s Treatment Record on June 5, 2001, but the entry provided only that Bactroban ointment was to be applied to the wound once a day. There is nothing in E.G.'s Care Plan, Treatment Record, or Medication Record to document that his wound was treated between June 5 and June 12, 2001, nor was there any indication in E.G.'s chart that anyone signed for the Bactroban ointment. Marion Neuhaus, the Director of Nursing at Life Care at the times pertinent to these proceedings, observed E.G.'s wound every day because E.G. came to her office to show her the wound and other bumps and scrapes he accumulated as he walked around the facility. Ms. Neuhaus noted that the wound was scabbed, that there was a pink area around the wound, and that there was no swelling or drainage. Treatment was begun on the wound on June 12, 2001, and it healed without any complications. Summary. AHCA has established clearly and convincingly that Life Care did not provide E.G. with the wound care that was ordered by his physician. AHCA has, however, failed to establish by even the greater weight of the evidence that the healing process of E.G.'s wound was compromised by this lack of treatment. Ms. Treakle observed E.G.'s wound on June 12, 2001, and noted that it was scabbed and red around the edges. Ms. Treakle concluded that this redness alone indicated that the wound was infected. This conclusion is undermined by the notation in the wound care instructions included with E.G.'s prescription from the Dermatology Center that "[s]ome redness and swelling are normal in the immediate area of the wound." Furthermore, Ms. Treakle did not follow E.G.'s wound after June 12, 2001, and the evidence presented by Life Care that E.G.'s wound healed in a timely manner is uncontroverted. AHCA has established clearly and convincingly that there are several omissions in the documentation of Life Care's monitoring of E.G.'s blood, but these omissions do not reasonably support the inference that Life Care failed to monitor E.G.'s blood sugar and administer insulin on these dates as required by the physician's orders; rather, Life Care's failure on these occasions was inadequate documentation, not inadequate care. AHCA has, however, established clearly and convincingly that Life Care did not monitor E.G.'s blood sugar as required by his physician's order at 11:30 a.m. on June 7, 2001; this inference may reasonably be drawn based on the lack of documentation and E.G.'s elevated blood sugar at the next check at 4:30 p.m. Ms. Treakle assumed that E.G. suffered actual harm as a result of this omission because, in her view, hyperglycemia, or elevated blood sugar, always causes damage to the body; Ms. Treakle could not, however, identify any specific harm to E.G. caused by this one omission. AHCA has failed to establish by even the greater weight of the evidence that E.G.'s physical well-being was compromised by Life Care's failure to monitor his blood sugar on this one occasion. Resident N.D. Fall from Shower Chair.8 At the times pertinent to these proceedings, N.D. was a 79 year-old woman who had been a resident of Life Care since October 26, 1999. According to the assessment of N.D. included in the Minimum Data Set completed on May 3, 2001, N.D. suffered from Alzheimer's disease, had long- and short-term memory problems, and was severely impaired and unable to make decisions; as of June 12, 2001, N.D. was almost entirely dependent on staff for all of the activities of daily living. N.D.'s Care Plan for November 6, 2000, which was updated with handwritten notes, reflects that she had poor safety awareness. The Interdisciplinary Notes maintained by Life Care reflect that, on June 5, 2001, a nurse observed N.D. leaning forward in her wheelchair at breakfast; this was the first mention of this behavior in N.D.'s chart. Dr. Gil, N.D.'s physician, included a notation in the Physician's Progress Notes for June 8, 2001, that he observed N.D. leaning forward but was unable to assess her abdomen because of her anxiety. The Interdisciplinary Notes reflect that Dr. Gil visited N.D. on Saturday, June 9, 2001, and that she was again leaning forward in her wheelchair, "almost falling out of [her] chair." Dr. Gil ordered an ultra-sound of N.D.'s abdomen and a "lap buddy while in w/c [wheelchair] to prevent falls." Dr. Gil's order was noted in the Interdisciplinary Notes for June 9, 2001, as well as on a physician's order form signed by Dr. Gil on June 10, 2001. According to Life Care's written policy, physician orders are to be transcribed into a patient's care plan, treatment plan, or medication administration record, depending on the nature of the order. Dr. Gil's order for a lap buddy had not been transcribed into N.D.'s November 6, 2000, Care Plan at the time Ms. Treakle conducted her survey on June 12, 2001.9 A lap buddy was used on N.D.'s wheelchair beginning on the morning of June 11, 2001. On the evening of June 11, 2001, CNA Nova Coleman was caring for N.D. Ms. Coleman had been working for Life Care for only a short time, and N.D. was one of the first patients Ms. Coleman cared for after finishing her initial training. Ms. Coleman was, however, not an inexperienced CNA, having previously worked at another nursing home. At approximately 8:30 p.m., Ms. Coleman and another CNA had just finished showering N.D., and N.D. was sitting in a shower chair; her hair had been toweled dry, and she was dressed in her night clothes. The second CNA left the room, and Ms. Coleman, who had been standing in front of N.D., moved to the back of the shower chair so she could push N.D. out of the shower area. As she moved around the chair, N.D. pitched forward and fell face-first onto the floor. Ms. Coleman tried to grab N.D. to stop her from falling, but N.D. toppled over so quickly that Ms. Coleman could not reach her. N.D. suffered severe bruises to her face and a laceration on her lip as a result of the fall, but she did not break any bones. Ms. Coleman had not been advised prior to the fall of N.D.'s tendency to lean forward in her chair. N.D.'s tendency to lean forward in her wheelchair should have been entered in her Care Plan, together with the requirement that a lap buddy was to be used whenever she was in a wheelchair. In addition, Ms. Coleman should have been briefed on N.D.'s condition, including her tendency to lean forward, before Ms. Coleman was allowed to care for N.D. Although a lap buddy was not ordered for the shower chair and, in fact, could not appropriately have been used on a shower chair, the former Nursing Director of Life Care conceded that there were other means by which N.D.'s fall could have been prevented.10 The former Nursing Director also conceded that the failure to brief Ms. Coleman on N.D.'s condition probably contributed to the fall from the shower chair. Summary. AHCA has established clearly and convincingly that Life Care failed to provide N.D. with the services necessary to prevent her from falling from the shower chair and injuring herself, that Life Care failed to provide services that met professional standards, and that Life Care failed to revise N.D.'s Care Plan to include the risk of her falling forward while seated and the approaches Life Care would take to prevent her from injuring herself. Life Care conceded that the Care Plan should have included N.D.'s tendency to lean forward while seated and Dr. Gil's order of June 9, 2001, that N.D. be provided with a lap buddy when she was in the wheelchair. Life Care also conceded that the CNA should have been briefed on N.D.'s condition before she was assigned to care for N.D. Life Care further conceded that, even though Dr. Gil did not specifically prescribe a restraint to be used in the shower chair, measures could have been taken to ensure that N.D. did not fall out of the shower chair. AHCA has also established clearly and convincingly that Life Care's failure to provide proper care to N.D. resulted in her suffering significant injuries to her face. Although the injuries were to soft tissue and ultimately healed, N.D.'s physical well-being was adversely affected. In addition, AHCA has established clearly and convincingly that, even had N.D. not fallen and suffered injuries, the failure to include in N.D.'s Care Plan her tendency to lean forward and its failure to transcribe the physician's orders regarding the lap buddy into the Care Plan could have caused a lapse in the care provided to N.D. that could have possibly resulted in injury.
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 Sustaining the reduction in the licensure status of Life Care Center of Port Saint Lucie to conditional for the period extending from June 12, 2001, to August 17, 2001; and Imposing an administrative fine in the amount of $5,000.00. DONE AND ENTERED this 15th day of May, 2002, in Tallahassee, Leon County, Florida. PATRICIA HART MALONO 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 15th day of May, 2002.
The Issue The issue in this cause is whether University Community Hospital's Certificate of Need Application to establish a new, 5-bed Level III neonatal intensive care unit in District 6 should be approved or whether St. Joseph's Hospital's Certificate of Need Application for the addition of 5 Level III beds to its existing Level III neonatal intensive care program in District 6 should be approved.
Findings Of Fact THE PARTIES Agency for Health Care Administration (AHCA) AHCA is the single state agency responsible for the administration of the CON program in Florida, pursuant to Section 408.034(1), Florida Statutes. AHCA preliminarily approved the UCH CON application to establish a new 5-bed Level III NICU and denied the application of SJH. University Community Hospital UCH is a 431-bed acute care, non-profit hospital located in northern Tampa, Florida. The hospital is licensed to operate 374 acute care beds, 10 Level II NICU beds, 20 comprehensive rehabilitation beds, and 27 skilled nursing beds. It is the third largest hospital in the Hillsborough County region and is a major tertiary institution in West- Central Florida. UCH operates six recognized "Centers of Excellence" including: The Women's Center, The Pepin Heart & Vascular Institute, The Pediatric Care Center, The Diabetes Treatment Center, The Center for Cancer Care, and The Orthopedic Center. UCH provides significant acute care services including cardiology, orthopedics, general surgery, ICU, CCU, obstetrics (OB), gynecology (GYN), emergency room, and others. In addition, UCH provides certain "tertiary" services including Level II NICU services, adult open heart surgery, angioplasty, and comprehensive rehabilitation services. UCH operates The Women's Center which was established in 1991 to address the special needs of women and respond to the growing patient demand from North Tampa and South Pasco. The Women's Center is a freestanding facility connected to the main hospital which provides a full range of OB, GYN, and newborn services. It houses delivery rooms, surgery rooms, mother/baby beds, GYN beds, an ante-partum unit for high-risk OB patients, 10 Level II NICU beds, a well-born nursery, prenatal and postnatal educational programs, and diagnostic equipment. The Women's Center operates the Advanced Reproductive Technology (ART) program which addresses infertility problems using state-of-the-art reproductive technologies. The UCH ART program is the largest of its kind in the Tampa Bay area, and draws many patients throughout West-Central Florida. In fact, the number of participating women has doubled in the last two years. Babies conceived from this program often require NICU services due to the age of participating women, increased pre- term delivery, high-risk medical conditions, and the frequency of multiple births. The facility also operates a special "high-risk" OB program designed to care for women with special prenatal needs. These women often require prior hospitalization, bed rest, extensive nursing attention, or medications, and frequently request to receive these services at UCH. As with the ART program, there is an increased chance for these high- risk mothers to give birth to babies needing NICU care. Since 1991, UCH has operated a 10-bed Level II NICU located in the Women's Center. While it was designed and equipped according to Level III NICU standards and possesses the highest quality of medical equipment available, the unit is not authorized to provide Level III NICU services. Approximately 1000 physicians hold hospital privileges at UCH. They include Board-certified physicians covering 35 medical specialties. The Women's Center employs three medical directors. Its medical staff includes 83 physicians who are specialists in OB, GYN, and/or pediatrics and six additional physicians who are specialists in maternal and fetal medicine. It provides a full range of pediatric services in its dedicated Pediatric Care Center and has physicians who are Board- certified in all pediatric specialty areas, including pediatric surgery. In addition to its extensive staff of doctors, the Women's Center also maintains a quality group of nurses in its Level II NICU, most of which are specially certified in neonatology and have significant experience in Level III units. The Women's Center was originally built to handle 2,000 - 2,200 births annually. However, due to factors including its location, population growth, and performance, the facility exceeded that capacity. In late 1999, UCH began construction of a $10 Million expansion, which was recently completed. Today, the facility has the capacity to handle 3,000 - 3,500 births annually. UCH is located in the North Tampa corridor which is experiencing a population growth. It is the northernmost hospital in Hillsborough County, and the closest tertiary hospital to Pasco County. UCH's primary service area for OB and Level II NICU patients is North Hillsborough and South Pasco. Approximately 20% of its OB and Level II NICU patient volume are residents of Pasco County. In 2000, UCH delivered 2,168 babies. The following year, in 2001, it increased to 2,269 births and the hospital reasonably projects its volume to reach 2,500 annual births in the near future. UCH's Level II NICU unit has been well- utilized over the past several years and has experienced a 16% volume increase per year since 1999. It has the highest growth rate of all Level II providers in District 6. UCH has twice previously applied for a 5-bed Level III NICU and was denied each time. The Agency's CON director stated that UCH was denied because: (a) at the time, there was no numeric need to support their proposal, (b) Tampa General had not previously supported their proposal, and (c) UCH had not previously provided written quality assurances to the Agency. St. Joseph's Hospital (SJH) SJH is a large, acute care, not-for-profit hospital, founded in central Tampa in 1934. It is licensed to operate 883 beds, including 15 Level II and 27 Level III NICU beds. SJH is fully accredited by the Joint Commission on Healthcare Organizations, and is a state-designated Level II Trauma Center. It is one of 15 hospitals nationwide designated to participate in National Cancer Research Institute clinical research protocols and provides adult open heart surgery services, and operates several major clinical institutes, including the Heart Institute, Cancer Institute, and Neuroscience Institute. SJH's licensed hospital beds are distributed among three hospital facilities located on one campus and include: St. Joseph's Women's Hospital, a 193-bed facility; St. Joseph's Hospital, a 550-bed facility; and Tampa Children's Hospital at St. Joseph's with 153 beds. Tampa Children's Hospital operates a specialty six- bed pediatric cardiac ICU, and a 16-bed pediatric ICU, and is one of the few providers in Florida offering pediatric cardiovascular surgery. In fact, it performs approximately 400 cardiac surgeries annually, with a majority performed on neonates. Twenty-seven of the 30 designated pediatric sub- specialties are represented on the hospital's active medical staff which is comprised of 200 physicians including 120 pediatric sub-specialists. In addition to its comprehensive pediatric and neonatal surgery programs, Tampa Children's Hospital participates in a fetal surgery program with St. Joseph's Women's Hospital, which involves close clinical cooperation between perinatologists specializing in high-risk obstetrics, and pediatric medical and surgical sub-specialists. Overview of CON Statutory and Regulatory Framework Sections 408.031-408.045, Florida Statutes, outline the establishment and expansion of certain tertiary health care services in the State of Florida and is known as the Health Facility and Services Development Act. Under the CON statutory framework, health care providers seeking to establish or expand certain health care services in the State of Florida must obtain CON approval prior to implementation of their proposal. Pursuant to Section 408.035, Florida Statutes, AHCA is required to review all applications in context with statutory and rule criteria and is the single state agency authorized to issue, revoke, or deny CON licensure. Overview of Level III Neonatal Intensive Care as a Tertiary Health Service Pursuant to Section 408.032(17), Florida Statutes, Level III neonatal intensive care is considered a "tertiary health service" which is defined as: health service which, due to its high level of intensity, complexity, specialized or limited applicability, and cost, should be limited to, and concentrated in, a limited number of hospitals to ensure the quality, availability, and cost- effectiveness of such service. Because of the tertiary nature of Level III NICU services, most hospitals in Florida do not offer Level III neonatal intensive care. Overview of Level II and Level III NICU Services Rule 59C-1.042, Florida Administrative Code, provides the specific requirements for Level II and Level III NICU programs. Pursuant to Section 59C-1.042(2)(g), Florida Administrative Code, Level II neonatal intensive care is restricted to neonates who weigh 1000 grams or more at birth and require at least 6 hours of nursing care per day. Ventilator services may be provided in certain circumstances. Level III care includes the treatment of neonates who weigh less than 1000 grams at birth and require at least 12 hours of nursing care per day. Level III neonates often have complex major congenital anomalies and require continuous cardiopulmonary support. Level II NICU providers are prohibited from providing Level III NICU services and are required to transfer all neonates of 1,000 grams or less to a Level III provider. Level III NICUs that do not provide treatment of complex major congenital anomalies are required to enter into a written agreement with another Level III provider for those services and transfer the neonate patient, if necessary. Although all Level II and Level III NICUs treat severely ill babies, Level III care involves heightened complexity and intensity due to the volatility of the Level III neonates. Their vital signs and medical status are subject to more rapid fluctuation and they usually require longer periods of respiratory support and mechanical ventilation which can result in the scarring, leakage, rupture or deterioration of the lungs. Existing Level III NICU Providers in District 6 Currently, there are three Level III NICU programs in District 6 including SJH which operates 27 beds, Tampa General which operates 21 beds and Brandon Regional Medical Center which operates an 8-bed Level III unit. Pre Hearing Stipulation Agreement Prior to hearing, the parties stipulated that certain provisions of the 12 CON statutory review criteria found in Section 408.035, Florida Statutes, were not in dispute while others remained in dispute. Specifically, the parties agreed to the following: The need for the health care facilities and health services being proposed in relation to the applicable district health plan is IN DISPUTE; The availability, quality of care, accessibility, and extent of utilization of existing health care services in the service district of the applicant is IN DISPUTE; The ability of the applicant to provide quality of care and the applicant's record of providing quality of care is IN DISPUTE. (However, both applicants' record of providing quality of care was stipulated as not in dispute); The need in the service district of the applicant for special health care services that are not reasonable and economically accessible in adjoining areas is IN DISPUTE; The needs of research and educational facilities, including, but not limited to, facilities with institutional training programs and community training programs for health care practitioners and for doctors of osteopathic medicine and medicine at the student, internship, and residency training levels is NOT IN DISPUTE; The availability of resources, including health personnel, management personnel, and funds for capital and operation expenditures, for project accomplishment and operation is NOT IN DISPUTE; The extent to which the proposed services will enhance access to health care for residents of the service district is IN DISPUTE; The immediate and long-term financial feasibility of the proposal is IN DISPUTE. (However, only as to whether the applicants could achieve their respective projections of utilization). The extent to which the proposal will foster competition that promotes quality and cost effectiveness is IN DISPUTE. The costs and methods of the proposed construction, including the costs and methods of energy provision and the availability of alternative, less costly, or more effective methods of construction is NOT IN DISPUTE. The applicant's past and proposed service to Medicaid patients and the medically indigent is IN DISPUTE. The applicant's designation as a Gold Seal program nursing facility pursuant to s. 400.235, when the applicant is requesting additional nursing home beds at that facility is not applicable and NOT IN DISPUTE. As to AHCA Rule 59C-1.042, Florida Administrative Code, the parties agreed that only the following criteria remain in dispute: (3)(h) Whether the proposal is consistent with the applicable district health plan as required in Section 408.035(1), Florida Statutes; (3)(k) The extent to which the applicant intends to serve the Medicaid and indigent population as found in Section 408.035(11), Florida Statutes; and (5) Whether the applicant has met the Minimum Unit Size requirement set out in Rule 59c-1.042(5), F.A.C., which states that an applicant "shall propose a Level III NICU of at-least 15 beds and should have 15 or more Level II NICU beds.." The NICU Proposals UCH Proposal UCH proposes to convert 5 of its acute care beds to 5 Level III NICU beds. The 5 Level III beds will be integrated into its 10-bed Level II NICU thereby creating a 15-bed combined NICU. UCH, in its proposal, agrees to provide the full range of Level III NICU services with the exception of pediatric cardiac catheterization and pediatric open heart surgery which require separate licensure. UCH intends to provide 24-hour, 7 days/week physician coverage of its Level III NICU. In certain circumstances, the hospital proposes to follow the practice followed at All Children's Hospital, Brandon Hospital, and Mease Hospital in Dunedin and have neonatologists "on call" and not physically present at UCH. AHCA supports their plan. As a condition for AHCA's approval, UCH agrees to commit at least 29.09% of its total Level III NICU patient days to Medicaid babies and at least 1% to indigent babies. In addition, UCH agrees to follow specific procedures to ensure high quality and consents to routine inspections by the Agency. There is significant medical/professional support for UCH's proposal. Several OB physicians in the Tampa area provided testimony favoring the proposal. They indicate that the UCH plan will improve the District's quality of health care and benefit mothers, babies, and families. Moreover, Tampa General Hospital, a local competitor, supports the project. In fact, Dr. Robert Nelson, the medical director of Tampa General, testified that despite the fact that most UCH newborns requiring Level III NICU care are transferred to his hospital, those babies would be better served by UCH. In addition, East Pasco Medical Center (EPMC), a large provider of extensive OB services within District 6 located directly to the geographic north of UCH, favors the plan. Given the fact that there is no Level III NICU provider in Pasco county, UCH is the closest major hospital to EPMC and would provide tremendous benefit to Pasco county's rapidly- growing patient population. Dr. Jeffery Angel, who serves as the medical director for perinatology at SJH, Brandon Hospital, and UCH, and heads the major perinatology group in Hillsborough County also supports the UCH proposal. He provided expert testimony and opined that Level III NICU services at UCH would greatly benefit neonate patients due to the obvious risks associated with their transport. Through implementation of its proposal, UCH purports to improve and promote continuity of care, patient and physician choice, patient access, quality of care, patient satisfaction, and competition. SJH NICU Proposal SJH also proposes to add 5 Level III NICU beds by converting 5 acute care beds. SJH, however, currently operates 27 of the 53 Level III NICU beds within District 6. While its existing Level III NICU unit provides excellent care, it has historically experienced peaks and valleys in utilization over the course of days or weeks within any given month, and it's occupancy rate has consistently been under 80%. Section 408.035(1), Florida Statutes, and Rule 59C- 1.042(3)(h), Florida Administrative Code. There is a need for the Level III health care facility and health service being proposed in relation to the District 6 Local Health Plan. Pursuant to Section 408.035(1), Florida Statutes, AHCA performed a bed need methodology for Level III NICU services and, notwithstanding SJH's occupancy rate, determined that District 6 required 5 additional Level III NICU beds in the January 2004 planning horizon. AHCA's projection of fixed need creates a rebuttable presumption of need that no party challenged. There is insufficient evidence to modify the fixed need determination. The evidence did, however, demonstrate that AHCA, using the Rule formula, rarely computes a numeric need for additional Level III NICU beds, and when need is determined, 1-3 beds are usually required. In fact, in District 6, the Agency has calculated a numeric need on one occasion in the past 12 years when it determined that 1 additional bed was necessary. Interestingly however, Rule 59C-1.042(5), Florida Administrative Code, states that hospital applicants "shall propose a Level III NICU of at-least 15 beds," which under the existing need formula, is mathematically impossible to generate within District 6 today or in the foreseeable future. As a result, under a strict and dispositive interpretation of that rule, all new applicants would automatically be locked out of the Level III NICU market. Recognizing that new Level III NICU programs could rarely, if ever, be established in Florida under that strict interpretation, AHCA has long interpreted the minimum size rule to be only one of the many review criteria which are weighed in evaluating the overall merits of a NICU proposal. Section 408.035(1), Florida Statutes, and Subparagraph 59C-1.042(3)(h), Florida Administrative Code, further require the Agency to consider the applicant's CON proposal for Level III NICU beds in relation to the applicable district health plan. The District 6 Local Health Plan includes two "preferences" for evaluating proposals for Level III. The first factor gives preference to Applicants who commit to provide the most Level III care to Medicaid and indigent patients. While Tampa General is the largest provider, UCH, in its proposal, agreed to commit 29.09% of the total Level III days to Medicaid patients and 1% to the indigent. SJH agreed to commit 25% of its aggregate patient days to Medicaid and/or indigent care. The second preference requires Applicants to analyze the need for more Level III beds and address the impact on existing providers. UCH comprehensively assessed both need and adverse impact, and demonstrated that its approval would not adversely affect the existing providers. Given the unchallenged published need and the District 6 Health Plan, and considering UCH's experience operating a quality, expanding OB program with an existing Level II unit in an overall growing OB market, the new bed need presents a unique and timely opportunity for UCH to enter the Level III NICU market. The UCH proposal will satisfy the Level III bed need in a manner that is consistent with the District Health Plan. Section 408.035(2), Florida Statutes. A UCH Level III unit will improve the availability, quality of care, accessibility and extent of utilization of existing health care facilities and health services in District 6. Pursuant to Section 408.035(2), Florida Statutes, the Agency properly considered the availability, quality, accessibility, and extent of utilization of Level III NICU providers in District 6. The evidence demonstrates that the UCH plan increases availability, ensures quality and continuity of care, promotes access, provides patient and physician choice, supports competition, and provides a better distribution of Level III services in District 6. The SJH plan, given the facility's existing number of Level III NICU beds and occupancy rate, would not improve availability, quality, access, or utilization, and would stifle competition. Availability and Accessibility of Quality Care AHCA is responsible for ensuring that each district maintains sufficient providers of quality care. While the parties agree that UCH provides excellent care to its Level II patients, SJH argues that there are sufficient providers of quality Level III care within District 6. Given the variables of the district, it is questionable whether SJH, Tampa General and Brandon Hospital provide quality care that is sufficiently accessible to all residents of the district. The experts agree that the field of OB medicine is largely unpredictable. As Dr. Angel explained, most high-risk and/or pre-term deliveries cannot be predicted; therefore, it is extremely difficult to determine, prior to birth, whether a baby will require NICU services. In fact, Dr. Dillon suggested that OB doctors correctly identify less than half of the women who will develop pre-term labor, pre-term delivery, or obstetric complications. And Dr. Greenberg admitted that only 15% of pre-term deliveries are accurately predicted. Complicating matters at certain hospitals, including UCH, some women fail to receive prenatal care, and simply appear for delivery. These high-risk, "walk-ins" are often drug-users and prostitutes that present significant risks of complications and problems to their babies. Frequently, they deliver pre-term infants who need the services of a NICU. The experts agree that it is generally preferable for high-risk mothers to give birth at a hospital with a Level III NICU. Given the indigent and Medicaid patient load as well as the increasing deliveries and significant Level II NICU utilization at UCH, it is determined that UCH presents a need for Level III beds in District 6. While transporting fragile neonates remains an option, there are many problems associated with newborn and maternal transports to other facilities. Some women are too medically unstable to be transported. Dr. Angel explained that although some transfers are reasonably safe, complications arise in neonatal and maternal transport and removing the risk improves the Level III care. SJH admits that separating mothers from their babies who are commonly suffering from a broad array of concurrent medical problems is not preferred. The ability to treat all medical issues in one setting by a coordinated network of medical professionals provides sick babies with an enhanced probability of survival and development. It allows a qualified hospital to successfully treat many babies which otherwise would be required to be removed from their mothers and transferred to another facility or another city. Under the UCH plan, the facility will be capable of treating all critically ill newborns. Doctors who serve at UCH will be able to maintain the continuity of care to the mother and newborn which is important in hospitals with large OB volume and an established Level II unit. In addition, patients in north Hillsborough and south Pasco counties will have access to a closer provider without the fear of transfer, separation anxiety or unnecessary risk. As previously indicated, UCH is a major provider of OB services in the northern section of Hillsborough county where the population is rapidly growing. And although UCH is less than a 2 hour drive from all other Level III providers in District 6, the closest Level III provider north of UCH is located in Gainesville. Given the county's expanding population base in the north and the level of traffic in the downtown Tampa area, the UCH proposal improves and promotes availability, accessibility and quality of care. Utilization The issue of utilization provides additional support for UCH to add Level III services. The NICU Rule calls for a facility to have at least 1500 annual births prior to developing a Level III unit and UCH delivers over 2,200 babies each year. In fact UCH currently has a higher birth volume than many Florida hospitals with Level III units. The Level III NICU utilization rate at SJH does not warrant 5 additional beds. Since 1998, SJH has operated below 80% occupancy for each year except 2000. In 2001, according to its internal data, SJH recorded 7,698 Level III patient days which equates to 78% occupancy with approximately 6 unused Level III beds per day. In the first quarter of 2002, SJH's occupancy rate fell to 76.5%. In addition, the birth volume at SJH appears to be decreasing. For example, its birth volume in the first quarter of 2002 was 4% less than its birth volume in the first quarter of 2001. If, in the future, SJH's birth volume rises and it increases its Level III occupancy to 90%, pursuant to 59C-1.042(3)(g), Florida Administrative Code, SJH can automatically demonstrate a need for additional Level III beds without showing any numeric need in District 6. Section 408.035(3), Florida Statutes. UCH can provide high quality care. While SJH argues that UCH lacks the depth of medical experience and resources necessary to operate a Level III NICU program, the evidence suggests otherwise. It is generally agreed that the components of high quality Level III care are quality physicians, quality nurses, and quality unit design and equipment. UCH possesses these components. UCH is a relatively new facility that utilizes the most recent medical equipment available. The hospital maintains a cadre of highly-trained, Board-certified doctors and nurses with extensive experience in Level III units. It currently provides quality care to its OB and Level II NICU patients and as Drs. Kanarek, Sosa, Angel, Hyatt, and Greenberg agreed, it is certainly capable of providing high quality Level III care. In addition, UCH has a proven track record of developing new services and expanding existing services in a high quality manner and possesses an experienced management team. Moreover, Dr. Kanerek, a Board-certified neonatologist who initiated Tampa General's Level III unit and managed it for several years, will continue to serve as the UCH NICU director. SJH further argues that UCH is less capable of providing quality care since mortality rates are better in high volume Level III facilities. The evidence suggests otherwise. Dr. Shiono, an expert in biostatistics and epidemiology testified there is no statistical correlation between NICU volume and patient outcome. In fact, she recently published a professional article entitled "Hospital and Patient Characteristics Associated with Variation in 28- day Mortality Rates for Low Birth Weight Infants," after comparing mortality rates of low birth weight infants with hospital characteristics. Her study concluded that there is no relationship between a hospital's volume of Level III babies and their mortality rates. The evidence in this case suggests the same. SJH has no better mortality rate for its Level III babies than the three 5-bed Level III units in Florida. In fact, between July 1997 and June 2001, their average mortality rates were as follows: St. Joseph's - 9.4%; West Boca Medical Center - 7.7%; Mease Hospital Dunedin - 3.0%; and North Shore Medical Center - 9.8%. Section 408.035(4), Florida Statutes. There is a need for special health care services in District 6 that are not reasonably and economically accessible in adjoining areas. The Agency is required to evaluate the need for Level III services in District 6 that are not reasonably accessible in adjoining areas. Undoubtedly, the UCH proposal will promote needed and improved accessibility to Level III NICU services for the residents of Pasco County. As discussed earlier, Pasco County is experiencing growth in population and there is no Level II or Level III NICU provider. UCH currently provides significant OB and Level II NICU care to the residents of Pasco since it is the closest major hospital to residents of East Pasco County. East Pasco Medical Center strongly supports the UCH proposal and Pasco patients will benefit from the plan. Section 408.035(5), Florida Statutes. The parties stipulated that the need for research and educational facilities is not at issue in this matter. Section 408.035(6), Florida Statutes. The parties stipulated that the availability of resources, including health personnel, management personnel and funds for capital and operating expenditures is not at issue in this matter. Section 408.035(7), Florida Statutes. The extent to which the proposed services will enhance access to health care for residents of District 6 has been discussed above. Section 408.035(8), Florida Statutes. The immediate and long-term financial feasibility of the UCH proposal is sound. While the parties agree that the immediate financial feasibility of the proposals is not in dispute, each party challenges the long-term feasibility and utilization projections of the other. As previously discussed, SJH has experienced consistent unused capacity. Smaller Level III providers, however, appear to maintain occupancy rates at 90% or greater. Over the past 5 years, Level III units with fewer than 15 beds have averaged 94.54% occupancy while larger units report 81.24%. In 2001, smaller units averaged 98.18%, while larger units averaged 81.97%. In District 6, between 1996-2000, Brandon Hospital, a 5-bed Level III provider, reported that its occupancy exceeded 94% each year and led the district average of all Level III providers. The long-term feasibility of the UCH proposal is sound. For further discussion, please see the discussion above regarding the issue of utilization. Section 408.035(9), Florida Statutes. The UCH proposal will enhance, foster and increase Level III NICU competition and improve quality and cost-effectiveness. SJH is the dominant Level III provider in District It currently operates 27 of the 53 Level III NICU beds in the district, however as previously described, SJH has plenty of unused Level III bed capacity. Its existing 27 beds can accommodate substantially more patient days than are currently being used. Adding 5 Level III beds to an already under- utilized provider will stifle competition. Moreover, the SJH proposal calls for higher Level III charges than UCH. In 2004, SJH proposes an average gross charge per patient day of $2,994, while UCH suggests $2,493. SJH's projected reimbursement rates from insurance and managed-care companies is higher as well. While the Medicaid program pays hospitals a flat fee for Level III care per day, regardless of gross charges, insurance and managed care companies negotiate reimbursement rates. In 2004, UCH proposes to be paid an average of $1,513 per day from insured patients while SJH proposes $2,898 per day. UCH proposes an average of $1,277 per day from managed care patients while SJH proposes $1,421 per day. In addition to its proposed net charges, SJH proposes a questionable increase in net revenues per day. In 2001, SJH received an average of $917 per day. In 2004 however, SJH proposes to increase its collection to $1,137/day, or 7.4 % per year. Since Medicaid reimbursement increases approximately 2%-3% per year, SJH must significantly increase its reimbursement from insurance and managed care companies to achieve their proposed net revenues. The evidence demonstrates that the SJH proposal does not promote competition or cost-effectiveness. Their proposed increases suggest that SJH operates as the dominant Level III provider in a non-competitive environment and may, unilaterally, be able to control pricing. The UCH plan, on the other hand, creates an environment and potential for price competition. Section 408.035(10), Florida Statutes. The costs and methods of the proposed construction are not at issue in this matter. Section 408.035(11), Florida Statutes. Both UCH and SJH have a long history of providing health care services to Medicaid and indigent patients and propose to continue their commitment. SJH and UCH treat all patients regardless of ability to pay, including OB patients and newborns. As a CON condition, UCH commits to provide a minimum of 29.09% of total Level III days to Medicaid patients and at-least 1% to indigents. SJH currently commits 25% of its Level III NICU volume to Medicaid and indigent patients combined and agrees to continue. Section 408.035(12), Florida Statutes. The applicants' designation as a Gold Seal program nursing facility pursuant to Section 400.235, is not at issue in this matter.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that: UCH CON Application No. 9492 is recommended for approval, and SJH's CON Application No. 9493 is recommended for denial. DONE AND ENTERED this 14th day of January, 2003, in Tallahassee, Leon County, Florida. ___________________________________ WILLIAM R. PFEIFFER 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 14th day of January, 2003. COPIES FURNISHED: James C. Hauser, Esquire Metz, Hauser & Husband, P.A. Post Office Box 10909 Tallahassee, Florida 32302-2902 Michael P. Sasso, Esquire Agency for Health Care Administration 525 Mirror Lake Drive, North Suite 310-G St. Petersburg, Florida 33701 Robert A. Weiss, Esquire Parker, Hudson, Rainer & Dobbs, LLP 118 North Gadsden Street The Perkins House, Suite 200 Tallahassee, Florida 32301 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308 Rhonda M. Medows, M.D., Secretary Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3116 Tallahassee, Florida 32308
The Issue Whether Certificate of Need Application Number 6785 should be approved for the conversion of 10 acute care medical/surgical beds to a 10 bed Level II neonatal intensive care unit at University Community Hospital.
Findings Of Fact On August 9, 1991, HRS published a fixed need pool for Level II and III Neonatal Intensive Care Services in the Florida Administrative Weekly, Volume 17, Number 32. For District 6, HRS published a "Preliminary Estimate of Bed Need" for an additional 10 Level II Neonatal Intensive Care Unit (NICU) beds, with an explanatory footnote which was as follows: "Due to pending litigation regarding the inventory of neonatal intensive care unit beds, no fixed need projection is made." The pending litigation was a challenge to the inclusion of 11 beds at Winter Haven Hospital ("Winter Haven") on the inventory of existing Level II NICUs. Following an amendment of the "grandfathering" rules, Winter Haven's dispute with AHCA was settled. Winter Haven's 11 bed NICU is included on the Level II inventory and its petition in this proceeding, which a Winter Haven witness described as their "fall back position", has been voluntarily dismissed. Humana of Florida, Inc., d/b/a Humana Women's Hospital Tampa ("Humana") intervened in these proceedings. Subsequent to the hearing and filing of proposed recommended orders, Humana entered its notice of voluntary withdrawal of its petition on March 17, 1993. AHCA is the state agency which administers CON laws, following transfer of that responsibility from HRS. See, Chapter 92-33, Laws of Florida. University Community Hospital ("UCH") is a 424 bed hospital in Tampa, Hillsborough County, Florida, AHCA District 6, with services which include open heart surgery, pediatric intensive care, and obstetrics. UCH began obstetrics services on September 2, 1991. In its first full year of operation, there were 1299 deliveries in its 31 bed obstetrics unit. UCH projected that there would be 1500 to 1800 deliveries in its second year of obstetrics services. Numeric Need and Occupancy Levels UCH filed its application to convert 10 acute care beds to establish a 10 bed Level II NICU on September 26, 1991, in response to HRS' August 9, 1991 publication of need. Total project cost was estimated at $765,000. Although HRS described the District 6 publication as a "preliminary estimate," there is no statutory or rule authority for the publication of any numeric need number other than the fixed need. By letter dated December 16, 1991, Tampa General Hospital ("Tampa General") notified HRS that the utilization data for Tampa General, which was used to calculate numeric need was incorrect. Tampa General reported 11,112 Level II NICU patient days for 1987, 11,387 for 1988, and, initially, 10,770 for 1990. Tampa General also reported a 20 percent increase in births from 1988 to 1990, and a 117 percent utilization increase in Level III NICU patient days. Tampa General's revised figures distinguished between services provided in its special care nursery and those provided in Level II NICU beds. The revised report divided the total 10,770 into 4,600 patient days in special care nursery beds and 6,170 in Level II NICU beds, but does not specifically take into account the intensity of nursing care or the severity of infants' conditions. Using 6,170 patient days, rather than 10,770, AHCA recalculated numeric need, determined that the numeric need was zero, and used zero need in reviewing the District 6, Level II NICU applications filed in this batch. AHCA did not publish the revised calculation of zero need. AHCA's policy is to not recalculate a fixed need pool, unless there is time to republish before applications are due. Nevertheless, AHCA takes the position that the need publication in this case may be revised because it was preliminary. Using the August bed need projection published by HRS, Level II NICU beds were reporting 86.5 percent occupancy in the twelve month period ending six months prior to the publication. If Tampa General's utilization rates are decreased from 114.28 percent to 70.43 percent, revised district utilization rates would decrease from 86.5 percent to 72.83 percent. Staffing ratios and costs indicate that some neonates in the Tampa General special care nursery received care consistent with Level II NICU services. There is more credible evidence to support the data used by the agency in its publication of need than there is to support its revised determination of zero need. Minimum 1,000 Births Rule 10-5.042(6), Florida Administrative Code, is, in relevant 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. There is no dispute that UCH initiated obstetrics services in September 1991, the same month in which it filed the CON application at issue in this case. Because the August 9, 1991 publication was the time for determination of need, then UCH does not meet the requirements of the rule. Standards For Review The publication of numeric need, minimum district occupancy levels, and minimum birth volumes are factors which determine the standard for review of CON applications. Due to the lack of any statutory or rule authority for the publication of preliminary estimates of numeric need, the nature and only possible effect of the pending litigation, AHCA's untimely revision of the numeric need number, and its failure to publish the revised number to allow a point-of-entry for challenges to the revised numeric need number and occupancy level, UCH is not required to demonstrate not normal circumstances. The failure to meet the minimum birth volume rule does, however, necessitate a showing of not normal circumstances for the approval of the UCH application. UCH assesses that its birth volume, and the number of neonates at UCH in need of Level II NICU care, the absence of available, accessible alternative hospitals, and the standard of care in the district are not normal circumstances which outweigh the minimum birth volume requirement. Available Alternatives Subsection 408.035(1)(b), Florida Statutes, also requires consideration of the availability, quality of care, efficiency, appropriateness, accessibility, extent of utilization, and adequacy of other Level II NICUs in the district. AHCA asserts that its corrected data showing zero need is a major indicator of available alternatives. As noted, however, UCH demonstrated the unreliability of the corrected data. In addition, geographic, economic, and other practical concerns may also affect accessibility. The total District 6 inventory of Level II NICU beds with 1990 occupancy and patient days as published on August 9, 1991, is as follows: Hospital Occupancy Patient Days Humana - Brandon 108.82 1,986 Humana Woman's 72.35 3,961 Tampa General 114.28 10,011 Manatee Memorial 90.23 1,976 Lakeland Regional 75.50 4,409 Winter Haven 49.02 1,968 The inventory is accepted as valid for the same reasons that the original publication of need is accepted as more reliable than the revised estimates. See, Finding of Fact 13. Tampa General's Level II and III nurseries are not available alternatives, because they exceed 90 percent occupancy. See, Findings of Fact 10 and 13. Humana Brandon is not an alternative with its Level II and III NICU beds exceeding capacity. Expert testimony on traffic practice and referral patterns support UCH's assertion that facilities in Winter Haven or Lakeland are not viable alternatives, although within the two hour travel time established by the rule on geographic access. Normal referral patterns are from more rural to more urban areas. Humana Women's, which is seven miles from UCH and has a transfer agreement with UCH, is the most geographically accessible, available alternative. The parties disagree over whether Humana Women's is economically accessible and has the capacity to serve most of the Level II neonates born at UCH. Humana Women's increased its service to 10-11 percent Medicaid obstetrics patients in 1991-1992, in contrast to UCH's level of 7 percent Medicaid obstetrics patients, and therefore, is no longer economically inaccessible to Medicaid patients. Humana Women's has 15 Level II NICU beds, which reported 72 percent occupancy in 1990. The demographic characteristics of the UCH service area include 7.1 percent Medicaid eligible population, and overlaps with the service area of Humana Women's. In addition, UCH and Humana Women's have overlapping medical staffs. For these reasons, Humana Women's experiences provide the most reliable indication of the accuracy of UCH's projections. At Humana Women's 7 percent of neonates require Level II and III care. By contrast, Lakeland Regional Medical Center experiences 12.7 percent neonates requiring NICU care, close to that projected by UCH, however, 30 percent of Lakeland Regional's patients are in the Medicaid payor category. The link between Medicaid and the greater need for NICU care was established by expert testimony. On this basis, the expert projections that 7 percent, not 10-15 percent, of UCH newborns will need Level II NICU care is accepted as reasonable. Average lengths of stay in Humana Women's Level II NICU beds were 6 to 7 days, not 10 days as projected by UCH. That data also supports AHCA's expert's conclusion that the average length of stay in UCH's stabilization unit, 2.3 days, is not indicative of UCH's having provided Level II care to 160 to 170 neonates. According to AHCA's expert planner, total capacity at Humana Brandon, Humana Women's and Tampa General is 14,000 patient days. Using the inventory published by the agency, those hospitals reported a total of 15,958 patient days in 1990. Even assuming that UCH overestimated the number of neonates needing NICU care, the capacity at accessible facilities within the district cannot accommodate the additional patients, and constitutes a not normal circumstance outweighing the minimum birth volume requirement. The fact that UCH is the only obstetrics facility in Hillsborough County without Level II and III NICU beds indicates that, if otherwise in compliance with review criteria, UCH's application should be approved to meet the need for additional Level II NICU beds. UCH's expert also testified that the number of Level II NICU beds in the Tampa area were disproportionately low compared to the population. Tampa has 3.2 Level II beds per thousand births in contrast to 7.6 in Lakeland, and 7.7 in Winter Haven. Given the demographic differences among the hospitals' service areas, the bed to population ratio was not shown to be meaningful as an indication of Level II NICU need. State and Local Health Plans Subsection 408.035(1)(a), Florida Statutes requires an evaluation of need in relation to applicable state and district health plans. The 1989 Florida State Health Plan lists the following general categories of preferences, most of which are applicable to any proposal to transfer or convert acute care beds regardless of the proposed new service: for conversion of acute care beds, for providing indigent care, for providing emergency services, for teaching, research and referral hospitals, and for providing specialized services. The District 6 plan issued in June 1990 by the Health Council of West Central Florida includes only one applicable CON allocation factor, which is related to the state health plan indigent care preferences and is as follows: Preference shall be given to an applicant who provides the department with documentation that they provide, or propose to provide, a disproportionate share of Medicaid and charity care patient days in relation to other hospitals in the subdistrict. The charity care definition shall be consistent with the definition used by the Health Care Cost Containment Board as defined in Chapter 89-275, Laws of Florida. The first group of preferences in the State Health Plan includes the following: Preference shall be given to a bed transfer and conversion application in which the applicant proposes a sizable reduction of excess beds in the existing facility. AHCA argues that the preference is not met. Because UCH has 404 licensed beds with an average occupancy of about 50 percent, or 200 empty beds, AHCA states that the conversion of only 10 medical-surgical beds to 10 Level II NICU beds is not a sizable reduction of excess acute care beds. However, AHCA only projected a need for an additional 10 NICU beds, which is the minimum size allowed by AHCA rules. AHCA's position that no additional Level II beds are needed is inconsistent with penalizing UCH for not proposing to convert more beds in this application. Therefore, this preference must be deemed inapplicable to this case. Similarly, given the size of the published need, the objective of reaching 75 percent occupancy in five years is also inapplicable to this application. The second relevant group of preferences relates to whether the conversion of beds will adversely impact disproportionate share providers. That same issue is also addressed in the group of preferences related to indigent care. AHCA argues that this preference is not met, because Tampa General, the only disproportionate share provider in the District, would be adversely affected. The evidence presented at hearing supports a conclusion to the contrary, that Tampa General will not be affected adversely. UCH and Tampa General have an agreement to cooperate in providing NICU services. UCH proposes to assist Tampa General in the delivery of Level III NICU services, by transfers of Level II neonates back to UCH as soon as possible. The fact that Tampa General's Level III utilization has increased substantially, more than 100 percent since 1988, was not disputted. Tampa General's medical director's testimony on the benefits to Tampa General of the agreement with UCH is persuasive. The next group of relevant preferences is entitled "Indigent care." The only local health plan factor also favors applicants which will provide a disproportionate share of Medicaid and charity care. UCH will not provide a disproportionate share of its services to Medicaid and charity care patients. The Level II NICU providers in District 6 average 40 percent Medicaid participation, and UCH proposes 6 percent. UCH does not meet the disproportionate share preferences in the state or local health plans. The "emergency services" group of preferences apply to applicants who (1)accept indigents for emergency care, (2)have a trauma center, (3) provide a full range of emergency services, and (4) have not been fined for violating emergency service statutes. UCH has an active emergency room, accommodating 45,000 visits in fiscal year 1991, and under expansion to increase its capacity to 60,000 visits a year. UCH, in general, meets the preference for providers of emergency room services. UCH is not a teaching, research, or referral center, nor is its proposed service unavailable within its service area. In response to this group of preferences, UCH has also not demonstrated that patients are leaving the state for this service, that any new physician specialities would be attracted to the area, or that its proposal will expand medical research in Florida. For the group of preferences for specialized services, UCH meets two of three applicable preferences. One for proposing a conversion of medical/surgical beds to NICU beds, another for proposing a commitment to serve 6 percent Medicaid and 5 percent charity care. In 1990, 41 percent of District 6 Level II NICU discharges were Medicaid patients. In 1990, Medicaid services ranged from a high of 61.6 percent of total Medicaid provided by Tampa General to a low of 2 percent by Humana Women's. UCH has shown its 6 percent Medicaid commitment to be reasonable and attainable by demonstrating that 7.1 percent of the population in its service area is Medicaid eligible. The actual Medicaid percentage in the first year for obstetrics services was 7 percent, which coincides with the percentage of Medicaid eligible persons living within the UCH service area. UCH has not emphasized specialized services to substance abusers, other than to have a referral network to community service agencies. The review of UCH's application in relation to state and local health plans results in the conclusion that the proposal is generally supported by preferences for the conversion of excess acute care beds, for not adversely impacting and potentially assisting Tampa General, for having emergency room services, and for providing specialized services with an attainable relatively low, Medicaid commitment. On the negative side are the preferences for applicants serving a disproportionate share Medicaid and charity patients, for teaching, research or referral centers, for services unique to the area, or for specialized service to substance abusing pregnant or postpartum women. On balance, the application of the state and local health plans does not suggest strongly that the UCH application either should or should not be approved, particularly in this case, where comparative review is impossible because UCH is the sole remaining applicant. Other Statutory Criteria Subsection 408.035(1)(c), Florida Statutes, criteria are met by UCH. UCH can provide good quality care in Level II NICU services. It is accredited by the Joint Commission on Accreditation of Health Organizations and has the ability to comply with rule requirements for equipment, staff and physical facilities. UCH already has a board-certified neonatologist on staff. Subsection 408.035(1)(e), favoring joint, cooperative or shared operation of health care services is not a criterion met by the UCH proposal. Although UCH suggests that its transfer agreement with Tampa General complies with the statute and the evidence showed that the two hospitals will cooperate in providing the separate services they each provide, but the transfer agreement does not constitute cooperative operation of the service. Subsection 408.035(1)(f), arguably is a basis for approval of the UCH application, because Level II NICU equipment and services do not exist in the adjoining area of east Pasco County. For District 5, which includes Pasco County, zero need was published for the same batching cycle. Subsection 408.035(1)(g) criterion, related to research and training programs, is not met by the UCH application. UCH meets the criteria in Subsection 408.035(1)(h), by having shown that it has the manpower, personnel and funds to establish and operate a 10-bed Level II NICU. UCH is able to renovate existing space and to acquire the equipment required for the 10-bed NICU for approximately $765,000. AHCA does not dispute UCH's assertion that it has adequate funds to finance this project and that project costs are reasonable. Having already hired a neonatologist, and 6 to 7 of the 11 1/2 to 12 1/2 full time equivalent or FTE's required, UCH has, or can recruit and hire, the necessary staff. Financial Feasibility Under Subsection 408.035(1)(i), the financial feasibility of a project must be considered. UCH estimated that a Level II NICU will generate $290,000 in year one, and $336,000 in year two revenues. The projections were based on providing Level II NICU services to 11 to 12 percent of newborns, or 2290 patient and 2670 patient days in years one and two, respectively. This underlying assumption is rejected. See, Finding of Fact 26. UCH's projection of a 10 day average length of stay in Level II NICU beds is not supported by Humana Women's experience of 6 to 7 days. See, finding of Fact 27. From the testimony and assumptions, attached to UCH's projected revenues and expenses, it is possible to determine that reduced total patient revenues will result from lower than projected numbers of patients and days. It is also apparent that deductions from revenue and some operating expenses will also decrease. There is, however, no testimony from which the relative proportions of adjustments to each item and the effect on charges for NICU services be calculated. Nor is there testimony regarding any minimum utilization necessary for the project to be financially feasible. Therefore, UCH has failed to meet the burden of showing that the proposed Level II NICU at UCH will be financially feasible. On balance, but not excluding all the applicable criteria, the most positive factors of the UCH proposal, the published need and potential benefits to Tampa General, do not outweigh the most negative ones, the failure to demonstrate financial feasibility and to make a more significant commitment compared to the district demand for Medicaid in Level II NICU beds.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the application of University Community Hospital for Certificate of Need 6785 to convert 10 acute care beds to 10 Level II neonatal intensive care beds be DENIED. DONE AND ENTERED this 8th day of October, 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 8th day of October, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO. 92-1490 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: UNIVERSITY COMMUNITY HOSPITAL Accepted in Findings of Fact 5 and 36. Accepted in Finding of Fact 6. Accepted in Finding of Fact 7. Accepted in Finding of Fact 2. Accepted in Finding of Fact 2. Accepted in Finding of Fact 3. Accepted in Findings of Fact 1 and 2. Accepted in Finding of Fact 2. Accepted in Finding of Fact 8. Accepted in Findings of Fact 9 and 10. Accepted in Finding of Fact 11. Accepted in Finding of Fact 11. Issue not reached. Issue not reached. Issue not reached. Accepted in Findings of Fact 10 and 11. Accepted in Finding of Fact 13. Subordinate to Finding of Fact 13. Accepted in Finding of Fact 10. Subordinate to Finding of Fact 13. Accepted in Findings of Facts 5 to 13. Subordinate to Finding of Fact 13. Subordinate to Finding of Fact 13. Accepted in Finding of Fact 13. Accepted in Findings of Fact 10 and 13. Accepted in Finding of Fact 47. First two sentences, Subordinate to Finding of Fact 6, Last two sentences, Rejected in Finding of Fact 26. Accepted in Finding of Fact 28. Rejected in Findings of Fact 50 and 51. Accepted in Finding of Fact 27. Rejected. Accepted in Finding of Fact 29. Accepted in Finding of Fact 36. Accepted in relevant part in Finding of Fact 34. Subordinate to Finding of Fact 26. Subordinate to Finding of Fact 26. Conclusion rejected in Finding of Fact 30. Rejected in Finding of Fact 41. Rejected in Findings of Fact 50 and 51. Accepted in relevant part in Finding of Fact 41. Accepted in Finding of Fact 34. Accepted in relevant part in Finding of Fact 38. Accepted in Findings of Fact 20, 22, and 28. Accepted in Finding of Fact 23. Accepted in Finding of Fact 25. Subordinate to Finding of Fact 25. Accepted in Finding of Fact 24. Accepted in Finding of Fact 29. Accepted in Finding of Fact 34. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Rejected in Finding of Fact 48. Rejected in Findings of Fact 50. Rejected in Findings of Fact 48. Subordinate to Finding of Fact 50. Subordinate to Finding of Fact 50. Unable to determine. Unable to determine. Accepted. Unable to determine. Rejected in Finding of Fact 45. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 47. Accepted in Finding of Fact 28. Issues not reached due to Humana's Voluntary Dismissal. Issues not reached due to Humana's Voluntary Dismissal.
