STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED (434)

Transcription

1 STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED A. PROJECT IDENTIFICATION 1. Applicant/CON Action Number Manatee Memorial Hospital LP/CON # Laurel Road Faber, VA Authorized Representative: Mr. Thomas Davidson (434) Service District District 6 (Hardee, Highlands, Hillsborough, Manatee and Polk Counties) B. PUBLIC HEARING A public hearing was not held or requested regarding the establishment of a 15-bed Level III neonatal intensive care unit (NICU) at Manatee Memorial Hospital located in Bradenton, Manatee County, Florida. Manatee Memorial Hospital, LP included 18 unduplicated letters of support in the application s Tabs D (five with the initial submission) and 4 (13 in the omissions submission). Seventeen were dated during January 29, 2013 through March 25, 2013, and one (Dr. Bernard Cartaya s) letter was not dated. Dr. Bernard Cartaya, Director of Neonatology, Sheridan Healthcare Services, states that as a provider of care to the newborns of this community, I can tell you that Level III neonatal care services are desperately needed in Manatee County. He also states that currently parents of critically ill infants must make a journey of over 30 miles to the closest Level III NICU in a neighboring county. Cristian Chiritescu, MD, FAAP and Alina Chiritescu, MD, FAAP with Ellenton Pediatrics submitted a letter which states that due to the lack of Level III NICU services in Manatee County, high risk expecting

2 mothers have to seek expert care in another county. This often results in undue traveling, separation from family and support system, and unnecessary anxiety and stress during an already demanding time. Ten support letters were form letters signed by local medical professionals including seven pediatricians, six physicians specializing in obstetrics and gynecology, and one advanced nurse practitioner. Several of the form letters were signed by multiple physicians. This letter indicates that: The absence of a Level III NICU in Manatee County has often resulted in higher risk pregnant patients leaving to seek care in another county. The distance, travel and separation from family and support network (sometimes including other children) produce additional stress during a naturally stressful time. Sometimes an infant born in Manatee County is transported to Level III NICU facilities outside Manatee County; causing separation between mother and infant, as well as potential medical consequences of transporting. This letter was also signed by Jennifer Bencie, MD, MSA, Administrator with the Manatee County Health Department and Jessica Capote- Dishaw, MD, FAAP, Chief of Pediatrics with Manatee County Rural Health Services. One letter from a mother of an infant treated at Manatee Memorial Hospital cites the quality of care experienced by her family. Another letter from a longtime Manatee County resident cites need for the project due to growing population trends. A medical student and Manatee County resident states that her experience behind the scenes in local health facilities convinced her of the need for Level III NICU services in Manatee County. Steve Dunn, Director, Strategic Business Services at All Children s Hospital, a Level III NICU provider in District 5 submitted a letter in opposition to the project. He states that the Agency s need formula resulted in zero need for Level III NICU beds in District 6 for the July 2015 planning horizon and that current Level III bed capacity exists in District 6 and surrounding districts. Mr. Dunn concludes that bed expansion beyond AHCA s demonstrated bed need formula only serve to further add to area health care costs by creating unneeded new bed capacity in a highly complex service and diluting patient volumes at established Level III NICU facilities in the area. 2

3 C. PROJECT SUMMARY Manatee Memorial Hospital, LP (CON #10179), an existing provider of Level II NICU care, is applying to establish a 15-bed Level III NICU at its facility located in Bradenton, Manatee County, Florida (District 6). Manatee Memorial Hospital, LP, a wholly owned subsidiary of Universal Health System (UHS), Inc., operates Manatee Memorial Hospital, a Class I general hospital licensed for 289 acute care, 24 adult psych, and six Level II NICU beds. The applicant indicates that it will add four beds to its six-bed Level II NICU in conjunction with this project. The applicant commits to a condition to provide a minimum of 75.0 percent of the Level III NICU s total annual patient days to the combination of Medicaid and charity patients. The total project cost is estimated at $7,978,335. The project involves 10,516 gross square feet (GSF) of renovated construction and 1,292 GSF of new construction 1. The project has a total construction cost of $3,311,800. D. REVIEW PROCEDURE The evaluation process is structured by the certificate of need review criteria found in Section , Florida Statutes. These criteria form the basis for the goals of the review process. The goals represent desirable outcomes to be attained by successful applicants who demonstrate an overall compliance with the criteria. Analysis of an applicant's capability to undertake the proposed project successfully is conducted by assessing the responses provided in the application, and independent information gathered by the reviewer. Applications are analyzed to identify strengths and weaknesses in each proposal. If more than one application is submitted for the same type of project in the same district (subdistrict), applications are comparatively reviewed to determine which applicant best meets the review criteria. Section 59C-1.010(3) (b), Florida Administrative Code, allows no application amendment information subsequent to the application being deemed complete. The burden of proof to entitlement of a certificate rests with the applicant. As such, the applicant is responsible for the representations in the application. This is attested to as part of the application in the certification of the applicant. 1 The Agency s architectural review indicates the applicant s narrative stated 10,822 GSF; numbers above are from the applicant s Schedule 9. 3

4 As part of the fact-finding, the consultant Jessica Hand analyzed the application with consultation from the financial analyst Everett Broussard, Bureau of Central Services, who reviewed the financial data and Said Baniahmad of the Office of Plans and Construction, who reviewed the application for conformance with the architectural criteria. E. CONFORMITY OF PROJECT WITH REVIEW CRITERIA The following indicate the level of conformity of the proposed project with the criteria and application content requirements found in Florida Statutes, sections , and , and applicable rules of the State of Florida, Chapters 59C-1 and 59C-2, Florida Administrative Code. 1. Fixed Need Pool a. Does the project proposed respond to need as published by a fixed need pool? Rules 59C-1.008(2) and 59C-1.042(3), Florida Administrative Code. In Volume 39, Number 13, dated January 18, 2013 of the Florida Administrative Register, a fixed need pool of zero beds was published for Level III NICU beds in District 6 for the July 2015 planning horizon. District 6 has 120 licensed and 18 approved Level III NICU beds. The district s existing beds are located in Hillsborough County; none are located in Manatee County. Lakeland Regional Medical Center, a Polk County facility, has Exemption number E to establish an 18-bed unit. Lakeland Regional met the criteria in s (3) (l) F.S., to establish its program by exemption from CON review. Manatee Memorial states intent to meet the required 10-bed Level II NICU unit size criterion to establish a Level III NICU. However, Manatee s reported 2,088 live births during the 12 months ending June 30, 2012, does not meet the exemption s minimum requirement that a facility have 3,500 births during the previous 12 months. The applicant is applying outside of the fixed need pool. b. Regardless of whether bed need is shown under the need formula, the establishment of new Level III neonatal intensive care services within a district shall not normally be approved unless the average occupancy rate for Level III beds in the district equals or exceeds 80 percent for the most recent 12-month period ending six months prior to the beginning date of the quarter of the publication of the fixed need pool. 4

5 As shown in the table below, the occupancy rate for District 6 s Level III NICU beds was percent during the 12-month period ending June 30, Eighteen additional Level III NICU beds are approved for Lakeland Regional Medical Center in Polk County. Level III Licensed Neonatal Intensive Care Services District 6 July 2011-June 2012 Facility Beds County Total Occupancy Brandon Regional Hospital 8 Hillsborough 58.44% St. Joseph s Hospital (+22-8/9/11) 49 Hillsborough 82.66% Tampa General Hospital 58 Hillsborough 59.28% University Community Hospital 5 Hillsborough 36.89% TOTAL % Source: Florida Hospital Bed Need Projections & Service Utilization by District, January 2013 Batching Cycle. c. Other Special Circumstances: Manatee Memorial Hospital, LP states that the proposed project is necessary to assure residents of Manatee Memorial Hospital s service area access to Level III NICU services. The applicant states need for the project due to 10 not normal circumstances: 1. There is no existing provider of Level III NICU services in Manatee County. 2. High outmigration levels of Manatee County Level III NICU qualified patients Manatee Memorial indicates that 44.7 percent (38 of the 85 total for these patients) were treated in other districts. The applicant also indicates that 26.0 percent (939 of 3,618 births) of Manatee County residents live births during the 12-month period ending June 30, 2012 occurred in hospitals located outside District Manatee County s neonatal mortality rate is higher than the state average. The applicant s Table 5, Infant Mortality Rates indicates Manatee County s 2011 infant mortality rate was 9.2 per thousand compared to the state s rate of 6.4 per thousand and Manatee County s rate exceeded the state s in each of these years. The reviewer confirmed this is correct based on Florida Department of Health, Bureau of Vital Statistics data obtained at 4. Manatee Memorial Hospital and its UHS affiliate Lakewood Ranch Medical Center are the sole providers of OB services to Manatee County residents. Blake Medical Center, Manatee County s other acute care hospital does not provide OB services. 5

6 5. Manatee County s rate of low birth weight births is lower than the state average 2. This factor, combined with the higher mortality rate, suggests to the applicant that Manatee County s neonates are being adversely affected by risk factors that Manatee Memorial and other community agencies can positively impact if Manatee Memorial is approved for Level III NICU services. 6. A high number of babies are born to teen mothers in Manatee County, with rising rates of Neonatal Abstinence Syndrome babies born to drug addicted mothers. The Florida Department of Health, Bureau of Vital Statistics Annual Report 2011, Table B-6 indicates that 335 or 9.96 percent of Manatee County s 3,362 births were by mothers under age 20. This compares to the state s 8.17 percent of such births (17,430/213,237) during CY Manatee Memorial Hospital delivers all of Manatee Rural Health Services babies. Manatee Rural Health Service is a Federally Qualified Health Center (FQHC) providing obstetric services to low income and/or high risk pregnant women who cannot obtain care from private practice providers. 8. Manatee Memorial Hospital is the only Level II NICU service provider in Manatee County. 9. Manatee Memorial Hospital is central to the infrastructure of health services in Manatee County; Level III NICU services are needed as part of comprehensive care for a growing population. 10. A review of medical literature supports the need for Level III NICU services at Manatee Memorial. The applicant asserts that the above stated special circumstances are supported by a quantitative assessment of the service area and resident needs. Analyses of existing provider locations, population growth, and demographic trends, as well as a review of medical literature, have been examined in order to estimate demand for Level III NICU services. Manatee Memorial indicates that NICU Level III patient day volume has risen by 31.5 percent during the previous five years, percentage occupancy has declined as beds have been added by the existing providers. The chart below shows the district s utilization and bed counts during the previous five 12-month reporting periods ending June 30, The Florida Department of Health, Bureau of Vital Statistics Annual Report 2011, Table B-5 indicates that Manatee County had 53 resident live births with birth weights of less than 1500 grams of its 3,362 total or 1.58 percent compared to the State s 1.61 percent (3,433 of 213,237). 6

7 District 6 Level III NICU Utilization 12-Month Reporting Periods Ending June 30, 2008 June 30, 2012 Reporting Period #Beds Bed Days Patient Days Occupancy ,062 29, % ,016 24, % ,820 20, % ,830 21, % ,228 22, % Source: Florida Hospital Bed Need Projections & Service Utilization by District, January As shown above, Level III NICU patient days decreased from 2008 to 2010, but increased by 40.0 percent from 20,774 for the 12 months ending June 2010 to 29,084 during the 12 months ending June Manatee Memorial notes that the majority of the increase in patient volume occurred at St. Joseph s Hospital with 14,115 patient days in 2012 compared to 10,596 in 2008 (a 33.2 percent increase) and Tampa General Hospital with 12,583 patient days in 2012 and 8,598 in 2008 or an increase of 46.4 percent. As demonstrated in the map below, there are four licensed and operational Level III NICU programs in District 6, all located in Hillsborough County. Lakeland Regional Medical Center (Polk County) has Exemption # to establish an 18-bed Level III NICU. 7

8 District 6 Licensed and Approved Level III NICU Providers and Manatee Memorial Hospital (CON application #10179) Source: Microsoft MapPoint The applicant cites outmigration of NICU Level III qualified neonates from Manatee Memorial Hospital to facilities in neighboring counties as a key factor in evaluating need of NICU Level III services at Manatee Memorial Hospital. Complications of outmigration underscore all 10 not normal circumstances cited above, which can be divided into three areas of concern: the central role Manatee Memorial Hospital holds as a provider of OB services to Manatee County residents; demographic challenges unique to Manatee County mothers and infants; and the risks transport to outside Level III NICU facilities presents to families and most importantly, fragile infants. 8

9 Manatee Memorial Hospital, and its affiliate Lakewood Ranch Medical Center, are the only providers of OB care in Manatee County, delivering a combined total of 2,625 live births during the 12 months ending June 30, Additionally, Manatee Memorial Hospital provides OB services to all mothers enrolled in Manatee Rural Health Services, an FQHC that provides care to high risk women who cannot obtain OB care from private practice obstetricians. The applicant states that as the only provider of Level II NICU care in Manatee County, Manatee Memorial Hospital is experienced in providing care to high risk infants, and seeks to expand its services to patients requiring a higher level of care. Babies who weigh less than 1,000 grams and babies that receive a complex medical intervention are counted as qualifying for Level III NICU services by the applicant. The applicant states that during the 12-month period ending June 30, 2012, 85 Manatee County Level III NICU eligible patients were discharged from Florida hospitals. The chart below illustrates discharges by destination for these patients, with 38 of the 85 infants discharged from facilities outside of District 6. Patient Destination Manatee County Level III NICU Eligible Patients 12-Month Period Ending June 30, 2012 Hospital Discharges Percent of Discharges Manatee Memorial Hospital Lakewood Ranch Medical Center Tampa General Hospital Subtotal District 6 Hospitals All Children s Hospital Sarasota Memorial Hospital Bayfront Medical Center Subtotal Other Districts Hospitals Grand Total Source: CON application #10179, Table 3. The applicant asserts the population of Manatee County mothers and infants present health care needs justifying a high level of care by the applicant. Citing the March 2007 publication Health Needs Assessment of Manatee County, the applicant states that: 9

10 Approximately 2/3 of Manatee County mothers obtained prenatal care during the first trimester, down from ¾ in the 1990 s. Overall, the number of mothers who receive late or no prenatal care is higher for Manatee County residents than the state average. The reviewer notes that during CY 2011, 73.7 percent of Manatee County mothers obtained prenatal care during the first trimester compared to the state s 80.3 percent. 3 Pre-term births (under 37 weeks gestation) accounted for roughly 13 percent of 2007 Manatee County births. The infant mortality rate in Manatee County is higher than the state average, and has risen while the state average declined during the time period. The neonatal mortality rate of Manatee County is also higher than the state average. The rate of post neonatal mortality in Manatee County is lower than the state average, indicating that neonatal care intervention is key to reducing infant mortality. Teen birth rates in every age category (10-14, 15-17, and 18-19) were higher than the state average. During CY 2011, Manatee County s age specific birth rate for mothers aged was 37.3 per thousand (329 births/8,824 population females 15-19) compared to the state s 29.1 aged birth rate. 4 Over the past 10 years Manatee County has seen a sharp increase in NAS (Neonatal Abstinence Syndrome), babies born to drug-addicted mothers. Fifty-two NAS infants were admitted to Manatee Memorial Hospital in Typically these infants require Level III NICU care. Finally, the applicant emphasizes the potential harm transport to Level III NICU services in other counties presents to both newborns and families in the following ways: By separating mothers from infants, breastfeeding and bonding, both of which influence the health of the infant, can suffer. The loss of local support networks, the separation of siblings from mothers and newborns, and difficulties traveling outside the county all present hardships for Manatee County families. Based on its review of medical literature, the applicant contends that long-term survival of high-risk infants is correlated to the availability of interventional services in the facility of birth. These risks can be avoided by ensuring the full spectrum of NICU services are available in the facility where the baby is born. 3 Source: Florida Vital Statistics Annual Report 2011, Table B-7: Resident Live Births By Trimester Prenatal Care Began, By County, Florida, Source: Florida Vital Statistics Annual Report 2011, Table B-12: Resident Live Births To Mothers 15 Through 19 Years of Age for Selected Indicators, and Age-Specific Births per 1,000 Females, By County, Florida,

11 Manatee Memorial provides the following table comparing Manatee County and Florida infant mortality rates during Manatee County and Florida Infant Mortality Rates Manatee County Florida Source: CON application #10179, Table 5 from Florida Department of Health, Office of Vital Statistics The applicant notes that Manatee County has had higher infant mortality rates per thousand births for every year during CY 2007 through 2011 compared to the state s. Manatee concludes that the differences in mortality rates are fully consistent with the conclusions of the clinical studies that correlate improved mortality outcomes based on the array of services available at the birthing hospital. However, Manatee Memorial also states that explanatory facts other than the absence of a Level III NICU in the County likely affected these outcomes. Manatee Memorial next addresses Manatee County s female population aged 15 to 44, which it states is projected to increase by nearly ten percent from (52,259 on July 1) 2011 to (57,332 on July 1) 2018 or 1.3 percent annually. Based on the projections in the Agency s Population Estimates February 2012 publication, the increase is 9.68 which results in an approximate 1.3 percent annual increase. The applicant notes that during CY 2016 (year one) the female population aged will be 55,683. Manatee Memorial projects 3,458 Level III NICU days, and with Manatee s market share at 85 percent the result will be 2,939 patient days or an ADC of 8.1 and 53.7 percent occupancy in the 15-bed Level III NICU. Manatee Memorial projects that the July ,508 female population aged 14-44, will result in 2,983 patient days in year two (2017) and 54.5 percent occupancy. Manatee Memorial states that it operates a large and growing OB program and has developed a maternal and child health program that largely addresses the needs of its patient population with the exception of a Level III NICU program. The outmigration for Level III services by residents of Manatee County is cited as need for the program. The applicant states that the hospital has many of the medical, nursing and other staff needed to develop the Level III program. Manatee Memorial concludes that the Level III NICU will improve patient outcomes and survival. 11

12 2. Agency Rule Preferences Please indicate how each applicable preference for the type of service proposed is met. Ch. 59C-1.042, Florida Administrative Code. a. Ch. 59C-1.042(3)(k), Florida Administrative Code - Services to Medically Indigent and Medicaid Patients. In a comparative review, preference shall be given to hospitals which propose to provide neonatal intensive care services to Children s Medical Services patients, Medicaid patients, and non-children s Medical Services patients who are defined as charity care patients. The applicant shall estimate, based on its historical patient data by type of payer, the percentage of neonatal intensive care services patient days that will be allocated to: (1) Charity care patients; (2) Medicaid patients; (3) Private pay patients, including self-pay; and (4) Regional Perinatal Intensive Care Center Program and Step Down Neonatal Special Care Unit patients. The applicant and its affiliate Lakewood Ranch Medical Center are the only hospitals providing obstetrical care in Manatee County. Manatee Memorial Hospital, LP indicates that the level of care provided to Medicaid and charity care patients is particularly high in regard to obstetric and NICU care. During the 12-month period ending June 30, 2012 approximately 86.1 percent of Manatee Memorial Hospital s OB patients were Medicaid patients, and 1.1 percent were self-pay. During the same period, approximately 86.0 percent of all Level II NICU cases were Medicaid patients, and 1.4 percent were charity or self-pay. b. Ch. 59C-1.042(4), Florida Administrative Code - Level III and Level IIII Service Continuity. To help assure the continuity of services provided to neonatal intensive care services patients: (1) The establishment of Level III neonatal intensive care services shall not normally be approved unless the hospital also provides Level II neonatal intensive care services. Manatee Memorial Hospital, LP provides Level II NICU services, and the establishment of Level III services will be in compliance with this. 12

13 (2) Applicants proposing to provide Level II or Level III neonatal intensive care services shall ensure developmental follow-up on patients after discharge to monitor the outcome of care and assure necessary referrals to community resources. Manatee Memorial states that in addition to providing in-hospital intervention services for infants at risk of developmental disabilities, hospital staff will evaluate patients prior to discharge and patients requiring follow up will be referred to Sarasota County s Early Steps program. The applicant also states it participates in Healthy Start, which provides nursing visits to prenatal clients and post-natal infants requiring services. c. Ch. 59C-1.042(5), Florida Administrative Code - Minimum Unit Size. Hospitals proposing the establishment of new Level III neonatal intensive care services shall propose a Level III neonatal intensive care unit with a minimum of five beds and should have 15 or more Level II neonatal intensive care unit beds. Hospitals under contract with the Department of Health and Rehabilitative Services Children s Medical Services Program for the provision of regional perinatal intensive care center or step-down neonatal special care unit are exempt from these requirements. Manatee Memorial Hospital, LP is proposing a 15-bed Level III NICU unit. The applicant currently operates a six-bed Level II NICU unit, which will be increased to 10 beds in connection with the Level III NICU project. While this is five beds short of the 15-bed Level II NICU requirement, the applicant notes that: The Agency has approved other Level III NICU projects that do not meet this criteria, including: Brandon Regional Hospital (14 Level II beds), Florida Hospital Tampa (10 Level II beds), Mease Hospital Dunedin (five Level II beds), and Sarasota Memorial Hospital (13 Level II beds); and contends that The combined 25-bed Level II and III NICU proposed by the applicant meets the forecasted patient bed need for Manatee Memorial Hospital. 13

14 14 CON Action Number: d. Ch. 59C-1.042(6) - Minimum Birth Volume Requirement. Hospitals applying for Level III neonatal intensive care services shall not normally be approved unless the hospital has a minimum service volume of 1,500 live births for the most recent 12-month period ending six months prior to the beginning date of the quarter of the publication of the fixed bed need pool. Specialty children s hospitals are exempt from these requirements. Manatee Memorial Hospital exceeded this standard by a substantial margin. For CY 2012, the applicant reported 2,165 live births. e. Ch. 59C-1.042(7) - Geographic Access. Level II and Level III neonatal intensive care services shall be available within two hours ground travel time under normal traffic conditions for 90 percent of the population in the service district. The applicant states this standard is met. However, the applicant states that current medical literature finds that the critical factor contributing to reduced 28-day mortality among at-risk infants is not whether they can be transferred to a hospital that provides an appropriate level of NICU care, but whether they are born in a hospital that provides an appropriate level of NICU care. Manatee Memorial Hospital, LP contends that its provision of Level III NICU services will ensure the best possible outcome for patients in this service area. f. Ch. 59C-1.042(8) - Quality of Care Standards. (1) Physician Staffing: Level III neonatal intensive care services shall be directed by a neonatologist or a group of neonatologists who are on active staff of the hospital with unlimited privileges and provide 24-hour coverage, and who are either board-certified or board-eligible in neonatalperinatal medicine. In addition, facilities with Level III neonatal intensive care services shall be required to maintain a maternal fetal medical specialist on active staff of the hospital with unlimited staff privileges. A maternal fetal medical specialist is defined as a board-certified obstetrician who is qualified by training, experience, or special competence certification in maternal-fetal medicine. Specialty children s hospitals are exempt from this provision. Manatee Memorial Hospital indicates that four neonatologists are currently on staff: E. Bernard Cartaya, MD; Marco T. Gonzolez, MD; Alberto Soto, MD; and Pablo Velencia, MD. The applicant includes the curriculum vitae (CVs) for these physicians in the application s Appendix C. One additional neonatologist will be hired in connection with this project. All neonatologists have full

15 15 CON Action Number: hospital privileges and provide 24 hours per day, seven days per week coverage. The applicant indicates that while it does not have a maternal fetal medical specialist, a qualified candidate will be selected and hired in connection with this project. (2) Nursing Staffing: The nursing staff in Level II and Level III neonatal intensive care units shall be under the supervision of a head nurse with experience and training in neonatal intensive care nursing. The head nurse shall be a registered professional nurse. At least one-half of the nursing personnel assigned to each work shift in Level II and Level III neonatal intensive care units must be registered nurses. Manatee Memorial Hospital s pediatric and Level II NICU departments are supervised by Rebecca Bouchard, RNC, BSN. Ms. Bouchard has achieved certifications in Neonatal Intensive Care, Neonatal Resuscitation, Pediatric Advanced Life Support, Basic Life Support, and has served as staff nurse in a Level III NICU in West Palm Beach. The proposed Level III NICU nursing staff will be under Ms. Bouchard s supervision. Ms. Bouchard s CV is included in the application s Appendix E. (3) Special Skills of Nursing Staff: Nurses in Level II and Level III neonatal intensive care units shall be trained to administer cardio-respiratory monitoring, assist in ventilation, administer I.V. fluids, provide pre-operative and post-operative care of newborns requiring surgery, manage neonates being transported, and provide emergency treatment of conditions such as apnea, seizures, and respiratory distress. The applicant states that a majority of nursing staff in the existing Level II NICU meet the above criteria, and staff of the proposed Level III NICU will be trained accordingly. Manatee Memorial includes the CVs for the Level II NICU nursing staff in the application s Appendix F. (4) Respiratory Therapy Technician Staffing: At least one certified respiratory care practitioner therapist with expertise in the care of Neonates shall be available in the hospitals with Level II or Level III neonatal intensive care services at all times. There shall be at least one respiratory therapist technician for every four infants receiving assisted ventilation. Manatee Memorial Hospital states a respiratory care practitioner trained in the care of neonates is available at all times in the existing Level II NICU and a ratio of one therapist to four infants

16 receiving assisted ventilation will be maintained. Appendix G of the application includes the CVs for the hospital s current respiratory therapy staff and other ancillary staff. (5) Blood Gases Determination and Ancillary Service Requirements: Blood gas determination shall be available and accessible on a 24-hour basis in all hospitals with Level II or Level III neonatal intensive care services. The applicant states that blood gas determination is available and accessible on a 24-hour basis. (6) Ancillary Service Requirements: Hospitals providing Level II or Level III neonatal intensive care services shall provide onsite, on a 24-hour basis, x-ray, obstetric ultrasound, and clinical laboratory services. Anesthesia shall be available on an on-call basis within 30 minutes. Clinical laboratory services shall have the capability to perform microstudies. All of the services specified are currently available on-site at Manatee Memorial Hospital. (7) Nutritional Services: Each hospital with Level II or Level III neonatal intensive care services shall have a dietician or nutritionist to provide information on patient dietary needs while in the hospital and to provide the patient s family instruction or counseling regarding the appropriate nutritional and dietary needs of the patient after discharge. The applicant maintains a dietitian or nutritionist to meet the patient s dietary needs while in the hospital and to provide the patient s family instruction or counseling regarding the appropriate nutritional and dietary needs of the patient after discharge. Manatee Memorial indicates that Eileen Bogo will oversee the clinical nutritional assessments and design of dietary regimens for patients of the proposed Level III NICU. Ms. Bogo s CV is included in Appendix H of the application. 16

17 17 CON Action Number: (8) Social Services: Each hospital with Level II or Level III neonatal intensive care services shall make available the services of the hospital s social service department to patients families which shall include, but not be limited to, family counseling and referral to appropriate agencies for services. Children potentially eligible for the Medicaid, Children s Medical Services, or Developmental Services Programs shall be referred to the appropriate eligibility worker for eligibility determination. Manatee Memorial Hospital states that a case management department is in place to counsel families, screen newborns, and refer for services in compliance with this condition. The applicant includes the CVs of the hospital s social workers in the application s Appendix I. (9) Developmental Disabilities Intervention Services: Each hospital that provides Level II or Level III neonatal intensive care services shall provide in-hospital intervention services for infants identified as being at high risk for developmental disabilities to include developmental assessment, intervention, and parental support and education. Manatee Memorial Hospital states that in-hospital services for infants identified as being at-risk for developmental disabilities are provided to NICU patients. (10) Discharge Planning: Each hospital that provides Level II or Level III neonatal intensive care services shall have an interdisciplinary staff responsible for discharge planning. Each hospital shall designate a person responsible for discharge planning. The applicant states that an interdisciplinary team coordinates discharge plans for each patient. The team includes the neonatologist, NICU nurses, case managers, hearing screening program representative, respiratory therapist, and physical medicine specialist. g. Ch. 59C-1.042(10), Florida Administrative Code - Level III Neonatal Intensive Care Unit Standards: The following standards shall apply to Level III neonatal intensive care services: (1) Pediatric Cardiologist. A facility providing Level III neonatal intensive care services shall have a pediatric cardiologist, who is either board-certified or board-eligible in pediatric cardiology, available for consultation at all times.

18 Manatee Memorial Hospital currently employs pediatric cardiologists qualified to provide care to Level II NICU and Level III NICU infants as required by this rule. The applicant includes the CVs for the pediatric cardiologists in the application s Appendix L. (2) Nurse to Neonate Staffing Ratio. Hospitals shall have a nurse to neonate ratio of at least 1:2 in Level III neonatal intensive care units at all times. At least 50 percent of the nurses shall be registered nurses. Manatee Memorial Hospital asserts that the nurse to neonate ratio will be in excess of 1:2 for the Level III NICU. All professional nursing staff assigned to the Level III NICU at Manatee Memorial Hospital will be registered nurses. Schedule 6A indicates 18.1 RN FTEs will be added in the first year of operation. The applicant projects to have a 7.7 average daily census (ADC) in year one) and an ADC of 7.8 in year two ending June 30, 2016 and 2017, respectively. Therefore, the applicant s projections exceed the nurse to neonate staffing ratio. (3) Requirements for Level III NICU Patient Stations. Each patient station in a Level III NICU shall have, at a minimum: a. Eighty square feet per infant; b. Two wall-mounted suction outlets preferably equipped with a unit alarm to signal loss of vacuum; c. Twelve electrical outlets; d. Two oxygen outlets and an equal number of compressed air outlets and adequate provisions for mixing these gases; e. An incubator or radiant warmer; f. One heated humidifier and oxyhood; g. One respiration or heart rate monitor; h. One resuscitation bag and mask; i. One infusion pump; j. At least one non-invasive blood pressure monitoring device for every three beds; k. At least one portable suction device; and l. Availability of devices capable of measuring continuous arterial oxygenation in the patient. The applicant reports that the facility will be in compliance with this rule. 18

19 19 CON Action Number: i. Ch. 59C-1.042(11) - Emergency Transportation Services: Each hospital providing Level II neonatal intensive care services or Level III neonatal intensive care services shall have or participate in an emergency 24-hour patient transportation system. (1) Provision of Emergency Transportation. Hospitals providing Level II or Level III neonatal intensive care services must operate a 24-hour emergency transportation system directly, or contract for this service, or participate through a written financial or non-financial agreement with a provider of emergency transportation services. (2) Requirements for Emergency Transportation System. Emergency transportation system, as defined in paragraph (11)(a), shall conform to section 64E-2.003, Florida Administrative Code. Manatee Memorial Hospital states that it will develop a 24-hour EMS patient transportation system agreement with the Manatee County Emergency Transport System. Training in correct patient transfer procedures will be provided to Manatee Memorial Hospital staff by Juan Reyes, of the Wolfson Children s Hospital in Jacksonville. Mr. Reyes is a board-certified neonatal pediatric transport and neonatal pediatric respiratory care specialist. Manatee Memorial Hospital will provide 24-hour emergency services that will enable it to transport infants from its Lakewood Ranch affiliate to Manatee Memorial or from Manatee Memorial to other Level III NICU facilities in Pinellas and Hillsborough Counties. j. Ch. 59C-1.042(12) - Transfer Agreements: A hospital providing only Level II neonatal intensive care services shall provide documentation of a transfer agreement with a facility providing Level III neonatal intensive care services in the same or nearest service district for patients in need of Level III services. Facilities providing Level III neonatal intensive care services shall not unreasonably withhold consent to transfer agreements which provide for transfers based upon availability of service in the Level III facility, and which will be applied uniformly to all patients requiring transfer to Level III, as defined in subparagraph (2)(e)2. An applicant for Level II or Level III neonatal intensive care services shall include, as part of the application, a written protocol governing the transfer of neonatal intensive care services patients to other inpatient facilities. Manatee Memorial Hospital currently maintains transfer agreements with All Children s Hospital for Level III NICU services and with Lakewood Ranch Medical Center for services not provided there. The

20 applicant states that it will not unreasonably withhold consent for transfer agreement with other area hospitals that provide only normal newborn or Level II NICU service if the Level III NICU facility is approved. k. Ch. 59C-1.042(13) - Data Reporting Requirements: All hospitals with Level II or Level III neonatal intensive care services shall provide the Agency or its designee with patient utilization and fiscal reports which contain data relating to patient utilization of Level II and Level III neonatal intensive care services. 1. Utilization Data 2. Patient Origin Data As an existing provider of Level II NICU services, Manatee Memorial Hospital currently complies with the Agency s data reporting requirements. The applicant states that the Level III component of the NICU will be incorporated into their existing data compilation and reporting upon project initiation. 3. Statutory Review Criteria a. Is need for the project evidenced by the availability, quality of care, accessibility and extent of utilization of existing health care facilities and health services in the applicant s service area? ss (1), (a) and (b), Florida Statutes. As previously stated, District 6 s 120 Level III NICU bed averaged percent occupancy during the 12 months ending June 30, 2012 and there are 18 Level III beds approved at Lakeland Regional Medical Center. Manatee Memorial Hospital, LP states that many of the issues itemized in this question have been addressed previously in response to Question E.1. Essentially, the applicant maintains a need for the project is evidenced by the availability, quality of care, accessibility and extent of utilization of existing Level III NICU services in the applicant s service area because none presently exist in Manatee County. The applicant reiterates the burden transport outside the county for NICU Level III care places on a disproportionately young and low income patient population, as well as the risks transport poses to the health of fragile infants. Studies demonstrating the improved survival rate of infants born in facilities providing appropriate levels of care are reiterated by the applicant. 20

21 Manatee Memorial Hospital concludes by saying that the Level III NICU program will be staffed by the same physician group providing care in the existing Level II NICU, thus enhancing quality and continuity of care. Additional staff needed for Level III NICU care will be hired and integrated easily into the existing healthcare system of Manatee County, in which the applicant is a central provider of health services. b. Does the applicant have a history of providing quality of care? Has the applicant demonstrated the ability to provide quality care? ss (1)(c), Florida Statutes. Manatee Memorial Hospital, LP, a wholly owned subsidiary of Universal Health System, Inc., is licensed to operate 289 acute care beds, 24 adult inpatient psychiatric beds, and six Level II NICU beds (which will be increased to 10 beds in conjunction with this project). The applicant states Manatee Memorial is accredited by the Joint Commission on the Accreditation of Healthcare Organizations. A copy of the hospital s Joint Commission accreditation is included in Appendix Q of the application. The applicant states that Manatee Memorial Hospital promotes quality control through a Quality Plan and Evaluation Policy initiative. This initiative provides a systematic, hospital-wide plan to measure, assess, and improve organizational performance, and is overseen by the Hospital s Board of Governors and its Quality Committee, as well as the Patient Safety Council, the Medical Staff Quality Improvement Committee, the Medical Executive Committee, and Quality Improvement Teams. Manatee Memorial states that it has committed to a long-term goal of comprehensive maternal and child health services, and in addition to its inpatient OB and Level II NICU it provides the following services including: Childbirth preparation classes Breastfeeding consultation and classes, post-partum lactation consultation AHA Heartsaver, Adult and Pediatric (CPR) Gestational Diabetes education Serum bilis with nurse assessment Transcutaneous bilis Healthy Start Komen Foundation (Breast Cancer) American Heart Association American Cancer Society Tours for School Children with Community Groups Car seat safety 21

22 Perinatal Bereavement support Newborn care classes Infant safety class Child Death Review of Manatee County. The applicant states that it seeks to enhance the quality of care for infants admitted or born at Manatee Memorial Hospital that need Level III NICU services. The applicant indicates that the absence of Level III NICU care at Manatee Memorial Hospital often results in a break in the continuity of care available to its patients and their families, and an underutilization of the highly specialized medical, nursing and other support personnel already available. Manatee Memorial restates that the Level III NICU will benefit its newborns, as well as Manatee County families who endure hardships of separation and travel burdens when a child needing Level III NICU care is transported out of the county. Manatee Memorial Hospital s parent company is Universal Health Services, Inc., which operates 15 hospitals in Florida with a total of 1,595 beds. Agency data obtained for the 36 months ending April 10, 2013, indicates that UHS facilities had 45 substantiated complaints, of which 16 substantiated complaints were for Manatee Memorial Hospital. A single complaint can encompass multiple complaint categories. The tables below list these complaint categories. Universal Health Services Substantiated Categories in the Past 36 Months Complaint Category Number Substantiated Nursing Services 7 Emergency Access 2 Resident/Patient/Client Assessment 3 Quality of Care/Treatment 22 EMTALA 2 Resident/Patient/Client Rights 8 Admission, Transfer & Discharge Rights 4 Restraints/Seclusion General 3 Administration/Personnel 4 Physician Services 1 Resident/Patient/Client Abuse 6 Physical Environment 1 State Licensure 3 Unqualified Personnel 1 Source: Agency For Health Care Administration complaint records. 22

23 Manatee Memorial Hospital Substantiated Categories in the Past 36 Months Complaint Category Number Substantiated Nursing Services 7 Emergency Access 1 Resident/Patient/Client Assessment 2 Quality of Care/Treatment 11 EMTALA 1 Resident/Patient/Client Rights 3 Admission, Transfer & Discharge Rights 1 Restraints/Seclusion General 2 Administration/Personnel 2 Source: Agency For Health Care Administration complaint records. c. What resources, including health manpower, management personnel, and funds for capital and operating expenditures, are available for project accomplishment and operation? ss (1)(d), Florida Statutes. Manatee Memorial Hospital, LP, operates a general hospital consisting of 289 acute care beds, 24 adult inpatient psychiatric beds and six Level II NICU beds (total 319 beds). The applicant is a wholly owned subsidiary of Universal Health Services, Inc. (Parent). The financial impact of the project will include the projected cost of $7,928,335 and incremental operating cost in year two of $4,810,424. The applicant states the project is to be funded by funds provided by its parent corporation, Universal Health Services, Inc. In support of this claim, the applicant provided a letter from the parent corporation as documentation of its commitment for funding the project. The letter of financial commitment stated parent company funding for this and other projects would come from either current cash balances or its revolving line of credit. The parent company states that as of December 31, 2012, the company had $574 million available under its $800 million line of credit. In support of the parent company s ability to fund the project, the applicant provided a copy of its parent company hospitals in the State of Florida combined audited financial statements for the period ending December 31, 2010, and December 31, In addition, the applicant provided a copy of the parent company s consolidated balance sheet and income statement from its form 10-K for the period ending December 31, 2011 and No other financial statements or notes to the financial statements from the 10-K were provided by the applicant. Therefore, these statements could not be used. 23

24 To supplement the financial statements provided by the applicant, staff retrieved a complete copy of the parent company s 12/31/2012 Form 10-K from the United States Security and Exchange Commission s website for analysis of the audited 12/31/2012 and 12/31/2011 consolidated audited financial statements contained within the 10-K. These statements were analyzed for the purpose of evaluating the parent s ability to provide the capital and operational funding necessary to implement the project. With regard to the line of credit, while the notes to the K disclose the line of credit and amount available as stated above, the applicant did not provide any documentation from the lender or independent third party to support the claimed line of credit and available funding under the line of credit. Short-Term Position Parent Combined 12/31/2011: The parent s current ratio of 0.9 is well below average and indicates current assets are approximately 0.9 times current liabilities, a weak position. The working capital (current assets less current liabilities) of negative $6.1 million indicates no excess liquidity that could be used to fund capital projects. The ratio of cash flow to current liabilities of -0.3 is well below average and a weak position. Overall, the parent has a weak short-term position (see Table 1). Long-Term Position Parent Combined 12/31/2011: The ratio of long-term debt to net assets of 1,690.7 is well above average and indicates that long-term debt is greater than equity, a weak position. The ratio of cash flow to assets of -5.4 percent is well below average and a weak position. The most recent year had revenues in excess of expenses of $38.7 million, which resulted in a 6.3 percent operating margin. Overall, the parent has a weak long-term position (see Table 1). Short-Term Position Parent Consolidated 12/31/2012: The parent s current ratio of 1.6 is below average and indicates current assets are approximately 1.6 times current liabilities, an adequate position. The working capital (current assets less current liabilities) of $513.4 million indicates excess liquidity that could be used to fund capital projects. The ratio of cash flow to current liabilities of 0.9 is above average and a good position. Overall, the parent has a good shortterm position (see Table 1a). Long-Term Position Parent Consolidated 12/31/2012: The ratio of long-term debt to net assets of 1.6 is well above average and indicates that long-term debt is greater than equity, a weak position. 24