STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED

Transcription

1 STATE AGENCY ACTION REPORT ON APPLICATION FOR CERTIFICATE OF NEED A. PROJECT IDENTIFICATION 1. Applicant/CON Action Number Bay Hospital, Inc. d/b/a Gulf Coast Medical Center/CON #10111 One Park Plaza Nashville, Tennessee Authorized Representative: Brian P. Baumgardner President & CEO (850) Service District/Subdistrict/County District 2 - Bay, Calhoun, Franklin, Gadsden, Gulf, Holmes, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, Wakulla, Washington Counties B. PUBLIC HEARING A public hearing was not held or requested regarding the establishment of a six-bed Level III neonatal intensive care unit (NICU) at Gulf Coast Medical Center located in Panama City, Bay County, Florida. Bay Hospital, Inc. included 14 unduplicated letters of support in the application s Tab 3. Twelve were dated during February 23, through March 2, Two letters were not dated. All but one of the applicant s support letters from medical professionals were a form letter. Nine were signed by local physicians. This letter expressed continued support for Gulf Coast s NICU growth and expansion and that this endeavor will fulfill a gap in service availability within our area. Furthermore, The proximity of Gulf Coast Medical Center s NICU is excellent for our families as we encourage them to be close to their baby. The letter concludes that the applicant has provided timely and efficient service while extending family centered care to our patients. Nine Emerald Coast obstetrics and gynecology staff members also signed this letter.

2 Samuel B. Wolf, Department of OBGYN Chairman at Gulf Coast Medical Center and a member of Emerald Coast Obstetrics, states that The advancement to Level III status will prevent the need for numerous transfers per year. He indicates that NICU care is traumatic enough for a family and when the baby is a hundred miles away with no family support it can be even more emotionally devastating. Dr. Wolf also cites the expectation of a large population growth in North Florida and the importance to implement changes to accommodate such growth. Three letters from the mothers of infants who were treated at Gulf Coast Medical Center s Level II NICU cite the facility s provision of quality care. These are not signed. C. PROJECT SUMMARY Bay Hospital, Inc., d/b/a Gulf Coast Medical Center/CON #10111 an existing provider of Level II NICU care, is applying to establish a six-bed NICU at its facility located in Panama City, Bay County, Florida (District 2). Gulf Coast Medical Center is a Class I general hospital licensed for 166 acute care and 10 Level II NICU beds. The applicant has notification # to add two Level II NICU beds, which will be in an area created by the construction associated with this project. The applicant commits to a condition to provide a minimum 65.0 percent of the Level III NICUs total annual patient days to the combination of Medicaid, Medicaid HMO and charity patients. The total project cost for the project is estimated at $3,064,509. The project involves 4,470 gross square feet (GSF) of new construction. The project has a total construction cost of $1,363,000. 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. 2

3 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. As part of the fact-finding, the consultant Marisol Novak analyzed the application with consultation from the financial analyst Robert Smith, who reviewed the financial data and architect Scott Waltz, who evaluated the architectural and the schematic drawings. 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 37, Number 3, dated January 21, 2011 of the Florida Administrative Weekly, a fixed need pool of zero beds was published for Level III NICU beds in District 2 for the July 2013 planning horizon. District 2 has 17 currently licensed Level III NICU beds and two approved beds and experienced percent utilization from July 2009-June Tallahassee Memorial Hospital is the only Level III NICU in the district. The applicant is applying outside of the fixed need pool. 3

4 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. As shown in the table below, District 2 s 17 licensed Level III NICU beds experienced an occupancy rate of percent during the 12-month period ending June 30, Level III Neonatal Intensive Care Services for District 1 and 2 Facility Beds County Total Occupancy % Tallahassee Memorial Hospital 17 Leon 74.96% Source: Florida Hospital Bed Need Projections & Service Utilization by District, January 2011 Batching Cycle. c. Other Special Circumstances: Gulf Coast Medical Center states that the proposed project is needed to assure residents of Gulf Coast s service area timely access to NICU services. The applicant contends that Medicaid recipients and other low income residents of the service area experience much more restricted access to NICU services than do other residents. Bay, Gulf, Holmes, Jackson, and Washington Counties are identified as the service area with Bay County as the primary service area (PSA). Below is a table identifying Gulf Coast Medical Center s newborn discharges by county. GCMC s Newborn Discharges By County of Residence July 2009-June 2010 County Number Percent Bay 1,935 79% Gulf 112 5% Holmes 50 2% Jackson 52 2% Washington 151 6% Other 137 6% Total 2, % Source: Page 8, CON application #10111 Gulf Coast Medical Center asserts that a Level III NICU program is needed to enhance access to persons residing in Bay, Gulf, Holmes, Jackson and Washington Counties. This need arises from the five not normal circumstances presented by the applicant: 4

5 5 CON Action Number: The existing Level III NICU program in District 2 is geographically mal-distributed. Tallahassee Memorial Hospital (TMH) is located in Tallahassee where residents of the westernmost portions of the service area are at the two-hour travel time limit via ground transportation from this service. The estimated ground travel time from Gulf Coast Medical Center to the Level III unit at TMH is on the cusp of two hours. Rule 59C (7) states that Level III neonatal intensive care services shall be available within two hours ground travel time under normal traffic conditions for 90% of the population in a service district. As of January 1, 2010 (the midpoint of the 12-month data reporting period), the population of District 2 was 734,110 and the population of Bay County was 169,980 persons. Given that the travel time from Gulf Coast Medical Center to TMH is right at the two-hour limit, and that a considerable amount of the population of Bay County lives south and/or west of the location of Gulf Coast Medical Center (including the entire beaches area) it is likely that the travel time standard is not met in this case. The Level III NICU unit at Sacred Heart Hospital in Pensacola is less accessible. According to MapQuest the travel time from Gulf Coast Medical Center to Sacred Heart is approximately 2.5 hours by ground transportation. 2. A nearly 200-mile gap exists between the Level III NICU programs at TMH and Sacred Heart Hospital in Pensacola (Escambia County, District 1). Gulf Coast Medical Center serves the area lying within this gap. 3. During the 12 months ended June 2010, 40 service area resident neonates were discharged from Level III NICUs. According to the Agency s hospital discharge data, Sacred Heart Hospital and TMH are the primary destinations for Level III neonates born to service area residents. However, neither is within a two-hour travel time of many service area residents. Furthermore, among Gulf Coast s five service area counties, only 14 residents of Jackson County utilized TMH (the Level III provider in District 2). Sacred Heart served 16 service area neonates. TMH did not serve Level III neonates who were residents of the four other counties including Bay County. 4. The proposed Level III NICU at Gulf Coast Medical Center will be staffed by the same medical director and neonatologists now serving the Level II NICU. Patient management practices will assure that all infants requiring NICU services are appropriately placed based on their specific care needs. 5. The proposed program will not adversely impact existing Level III NICU providers.

6 The applicant asserts that the above stated special circumstances are supported by a quantitative assessment of the service area and its needs. Analyses of use rates, population growth, demographic trends, and other potential influences have been examined in order to estimate demand for Level III NICU services. Volume forecasts for the proposed program are based on 12-month periods beginning with the anticipated initiation of service in January There are two licensed and operational NICU programs located within AHCA Health Planning District 2. Gulf Coast Medical Center operates a 10-bed Level II NICU in Bay County. TMH operates a 13-bed Level II NICU and a 17-bed Level III NICU at its campus in Leon County. The TMH programs accounts for percent of District 2 s Level II NICU beds and all of the district s Level III NICU beds. There are no other licensed NICU beds located in District 2, but TMH does have six approved Level II NICU beds and two approved Level III NICU beds and Gulf Coast has two approved Level II NICU beds. Gulf Coast Medical Center notes that Leon County is the most populated county in District 2. However, the applicant states that while TMH serves Leon County along with the other seven counties east of the Apalachicola River plus Calhoun County Gulf Coast serves the other five counties which accounted for 40 percent of the live births in See table below. Live Births By County, District 2, 2009 County Births Number Percent Bay 2,310 27% Gulf 138 2% Holmes 225 3% Jackson 548 6% Washington 263 3% GCMC Service Area 3,484 40% Calhoun 176 2% Franklin 128 1% Gadsden 692 8% Jefferson 155 2% Leon 3,122 36% Liberty 86 1% Madison 229 3% Taylor 285 3% Wakulla 317 4% Total 8, % Source: Page 11, CON application #10111 The applicant contends that the Level III NICU programs serving District 2 are mal-distributed close to a 200-mile gap exists between the Level III NICU service at TMH and the Level III NICU service at Sacred Heart (District 1) used by some residents of Gulf Coast s service area. 6

7 Gulf Coast maintains it serves the area lying within the gap, and if the proposed project is approved, it may improve access for residents of southern Okaloosa and Walton counties in District 1 as well. Gulf Coast Medical Center states that as of January 1, 2010 (the midpoint of the 12-month data reporting period), the population of District 2 was 734,110 and the population of Bay County was 169,980 persons 1. Given that the travel time Gulf Coast to TMH is right at the two-hour limit, and that Gulf Coast contends that considerable population in Bay County lives south and/or west of the location of Gulf Coast the applicant concludes that the travel time standard in Rule 59C (7) is likely not met in this case. Below is a map of the current Level III NICU locations serving Gulf Coast s service area, along with their proposed facility. As shown, Bay Hospital, Inc. states that no existing or approved Level III NICU program lies within a 75-mile radius of Gulf Coast Medical Center. However, the applicant contends that approval of the proposed project would place all acute care hospitals in its five-county service area within a 60-mile radius, comfortably within the two-hour travel requirement. 1 This data was confirmed by the reviewer with the AHCA Population Estimates 2000 to 2020 published September

8 CON # Bay Hospital, Inc. d/b/a Gulf Coast Medical Center & Level III NICUs in Closest Proximity Source: MapPoint 2006@Microsoft As to current utilization of NICU beds in District 2, the applicant states that the occupancy rate for the 10-bed Level II NICU at Gulf Coast Medical Center 2 was 96.2 percent well above the occupancy norm, indicating a high degree of need for such services within the service area. Bay Hospital, Inc. contends that its occupancy rate provides clear evidence of its capability to effectively operate an NICU program. Below are the annual occupancy rates for the district NICU beds and the quarterly occupancy rates for Gulf Coast Medical Center s Level II NICU according to the most recent published Agency data. 2 Gulf Coast Medical Center is currently approved by the Agency for two additional Level II NICU beds, but has not licensed these beds. 8

9 District 2 NICU Occupancy Rates, July 2009-June 2010 Occupancy by Level Hospital County Level II Level III Total Gulf Coast Medical Center Bay 96.16% NA 96.16% TMH Leon 82.02% 74.96% 78.04% Total 88.19% 74.96% 82.58% Source: Florida Hospital Bed Need Projections & Service Utilization by District, 1/2011 Gulf Coast Medical Center Quarterly Level II NICU Occupancy Rates July 2009-June 2010 Bed # July-Sept Oct-Dec Jan-Mar Apr-Jun Total % 79.67% 89.00% % 96.16% Source: Florida Hospital Bed Need Projections & Service Utilization by District, 1/2011 Preliminary utilization data from the Local Health Council for January 2010-December 2010 shows a percent annual utilization for Gulf Coast Medical Center s Level II NICU service. Gulf Coast Medical Center notes that Level III utilization at TMH (the only Level III NICU service in District 2) averaged 75 percent, slightly below the 80 percent threshold. However, the applicant lists five mitigating factors it contends support approval of its application: An addition of just one neonate per day at TMH would have resulted in an annual occupancy in excess of 80 percent. TMH s Level III NICU occupancy rose dramatically during the first six months of TMH is approved for six additional Level II beds and two additional Level III beds, indicating that TMH recognizes that these beds are in short supply in the district. The estimated ground travel time from Gulf Coast to the Level III unit at TMH is on the cusp of two hours, leaving much of Bay and Gulf County not meeting the travel time standard of Rule 59C (7) F.A.C. The Level III NICU unit at Sacred Heart Hospital in Pensacola is even less accessible approximately 2.5 hours by ground transportation. Gulf Coast Medical Center s five-county service area s projected population growth among women (child-bearing age) is -0.2 percent or a decrease of 248 women from January January The applicant notes that given the flat rate of growth among fertile females within the service area, the number of live births is not expected to vary much over the next five years. However, Gulf Coast cites the baby-boom echo resulting in children of the baby-boom generation entering into their prime child-bearing years causing fertility rates to rise over the next several years. Gulf Coast notes that it discharged 2,437 newborns during the 12-month period ending June

10 The applicant gathered data on the 40 neonates who were residents of the five counties comprising Gulf Coast Medical Center s NICU service area who were discharged from a Florida Level III NICU during July 2009-June Thirty-three of the 40 discharges came from Bay and Jackson Counties. Bay County accounted for percent, 759 of 1,420, of the total patient days. The applicant indicates that neonates from Jackson County had an average length of stay of 23.1 days compared to Bay s 50.6 days suggesting a greater severity of illness associated with neonates from Bay County. Below is the Level III NICU utilization provided by the applicant. Level III NICU Utilization: Gulf Coast Medical Center Service Area Residents July 2009-June 2010 County of Residence Bay Gulf Holmes Jackson Washington Total Discharges 1 Sacred Heart TMH Shands Healthpark MC 1 1 Total Patient Days Sacred Heart TMH Shands Healthpark MC 9 9 Total ,420 Average Length of Stay (ALOS) Sacred Heart TMH Shands Healthpark MC Avg. Total Source: Page 16 of CON application #10111 Gulf Coast gathered Level III NICU services by area of residence to show that access disparity has dampened the utilization of Level III NICU care. The applicant contends that not only do service area residents use Level III NICU services less (1.2 percent vs. the District 1 and 2 average of 4.6 percent) but their ALOS is higher than the average (35.5 days vs days) because only the most critically-ill neonates are receiving Level III care. 10

11 NICU III Utilization by Area of Residence, July June 2010 Discharges Area NICU III Other Total % NICU III Gulf Coast Medical Center Service Area 40 3,236 3, % District ,704 7, % Other District ,610 5, % Total ,550 16, % Patient Days NICU III Other Total % NICU III Gulf Coast Medical Center Service Area 1,420 9,175 10, % District 1 4,659 24,615 29, % Other District 2 8,096 11,098 19, % Total 14,175 44,888 59, % ALOS NICU III Other Total Gulf Coast Medical Center Service Area District Other District Total Source: Page 17 of CON application #10111 The major not normal circumstance justifying approval of the proposed project according to the applicant is access. Specifically, the applicant cites that 90 percent of the population of District 2 is not within two hours ground travel time of a Level III NICU. According the Mapquest data obtained on April 29, 2011, door-to-door travel time from Gulf Coast Medical Center to TMH is two hours and three minutes ( miles) by I-10, two hours and eight minutes (98.03 miles) by SR-20. Therefore, the applicant concludes that persons residing in Bay County south and/or west of Gulf Coast Medical Center are beyond two hours travel time to TMH. The applicant notes that Sacred Heart Hospital is used by some residents of Gulf Coast s PSA. According to MapQuest data obtained by the reviewer, door-to-door drive time from Gulf Coast Medical Center to Sacred Heart is two hours and 25 minutes ( miles). Gulf Coast Medical Center asserts that 113,122 is the estimated population for the seven zip codes in District 2 that are outside the twohour ground travel time of existing Level III NICU services (see table below). The total population for the district is 730,613. Therefore, less than 90 percent of the district s population is within two hours ground travel time and the access standard in the rule supports approval of the project requested by the applicant. 11

12 Bay and Gulf Counties 2010 Population Estimates by Zip Code Area Zip City/Place Population Panama City 23, Panama City 2, Panama City 36, Panama City Beach 9, Panama City Beach 15, Panama City Beach 16, Port St. Joe/Mexico Beach 9,126 Total Beyond Two Hours 113,122 District 2 730,613 % Beyond Two Hours 15.5% % Within Two Hours 84.5% Source: Page 18 of CON application #10111 The applicant calculated a utilization forecast for the proposed project using a constant rate since the projected female population will remain essentially flat so the 40 discharge rate from PSA remains constant as well. Gulf Coast Medical Center also assumed a 35.5 average length of stay (ALOS), a six percent out-of-area patient base, and 80 percent capture of need for year one and 90 percent capture of need for year two. Below is a table containing the applicant s projected utilization. Gulf Coast Medical Center Utilization Forecast CY 2014 CY 2015 Percent of Need Met by Gulf Coast Medical Center 80% 90% Service Area Resident Patient Days 1,136 1,278 Out-of-Area Days Total Days 1,209 1,360 Average Daily Census Beds 6 6 Occupancy 55.2% 62.1% Source: Page 20 of CON application #10111 The applicant maintains that 55.2 percent for year one and 62.1 percent for year two are acceptable occupancy rates for a start-up program consisting of a modest six beds. Gulf Coast Medical Center states that given occasional peak census fluctuations, annual occupancies as forecast will give it the flexibility to manage any peak loads without difficulty. Gulf Coast Medical Center maintains that the proposed project will not negatively impact the financial viability or ability to provide high quality care at existing Level III NICU programs. The applicant contends that the number of cases potentially redirected from these providers will, on an individual basis, be so small as to have no significant effect on the overall operations or financial health of these large institutions. 12

13 Based on current discharge data of Gulf Coast s PSA residents (using a flat growth rate because of the projected female population rate), TMH will lose 267 patient days or an average daily census of 0.7 in Sacred Heart would lose 711 patient days, a 1.9 ADC. Shands at UF would lose 0.4 ADC. 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 is the sole District 2 Level III NICU applicant in this batch. Gulf Coast expects to provide services to all patients who require Level III NICU services as they already do in the existing Level II unit. Gulf Coast indicates that utilization by payer for the project will be 68.1 percent Medicaid & Medicaid HMO, 16.0 percent commercial insurance, 14.4 percent Tricare and other federal government patients and approximately 0.8 percent private pay including self-pay patients. The applicant s notes to Schedule 7A indicate that while no charity care is identified specifically, it will provide some charity care, which it includes in self-pay. Children s Medical Services patient volume is expected to be very small and would typically be a subset of Medicaid patients. No revenues are expected from patients covered through provisions for regional perinatal intensive care center program and step down neonatal special care unit patients. 13

14 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. Gulf Coast Medical Center provides Level II NICU services, and the establishment of Level III services will be in compliance with this. (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. Gulf Coast Medical Center states that when developmental intervention needs are identified in the NICU, information is provided to staff, parents and volunteers. The developmentalist, the dedicated NICU physical therapist, parents, neonatal nurse clinician and the NICU discharge teamwork together to identify developmental needs of babies at discharge and make referrals as necessary to ensure those needs are met. Developmental follow-up is currently, and will continue to be, provided by the social worker assigned to the unit after discharge to monitor the outcome of care. 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. Gulf Coast Medical Center is proposing a six-bed Level III NICU unit. The applicant states that this is an appropriate Level III unit size for Gulf Coast and is expected to be adequate to meet anticipated service area patient utilization needs through at least The unit will be fully integrated with the Level II unit, will be designed to the highest modern standards for facility and equipment and will be fully staffed at levels meeting or exceeding all requirements. Gulf Coast Medical Center asserts the project is sound and viable from a financial perspective, thereby ensuring its operational stability. 14

15 The applicant states that there is ample precedent for agency approval of the proposed unit because several NICU projects have been approved during the last several years with beds less than the 10-bed minimum. Gulf Coast Medical Center concedes that unit size is one criterion employed to determine need, but that the Agency has indicated in the past the need for a program and ensuring the quality of the program are more important considerations. The applicant believes it fully documents both the need for local access to Level III NICU services and Gulf Coast s commitment to development and operation of a quality program. 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. Gulf Coast Medical Center exceeded this standard by a substantial margin. Between July 2009 and June 2010, Gulf Coast reported 2,437 newborn discharges from the hospital. 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 that this standard is not currently met for Level III NICU services in District 2. Gulf Coast Medical Center states that at present, 90 percent of the population of District 2 are not within two hours ground travel time under normal traffic conditions of a Level III NICU. According to MapQuest, the door-to-door travel time from Gulf Coast Medical Center to Tallahassee Memorial Hospital, District 2 s only Level III NICU provider, is right at two hours. Sacred Heart Hospital in District 1, the next closest Level III NICU, is less accessible at approximately 2.5 hours door-to-door from Gulf Coast. Gulf Coast Medical Center asserts that 113,122 is the estimated population for the seven zip codes in District 2 that are outside the twohour ground travel time of existing Level III services (see table). The total population for the district is 730,613. Therefore, less than 90 percent of the district s population is within two hours ground travel time and the access standard in the rule supports approval of the project requested by the applicant. 15

16 Bay and Gulf Counties 2010 Population Estimates by Zip Code Area Zip City/Place Population Panama City 23, Panama City 2, Panama City 36, Panama City Beach 9, Panama City Beach 15, Panama City Beach 16, Port St. Joe/Mexico Beach 9,126 Total Beyond Two Hours 113,122 District 2 730,613 % Beyond Two Hours 15.5% % Within Two Hours 84.5% Source: Page 27 CON application 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. Gulf Coast indicates that Helen V. Fountain, M.D. has been the NICU s Medical Director for the last five years. Sheridan Healthcare s Children s Services division provides the neonatal expertise and there are more than 10 additional neonatologists on staff. All neonatologists are on active staff of the hospital with full privileges and provide 24 hours per day, seven days per week coverage. Curricula vitae for Dr. Fountain and the neonatologists and other NICU physicians are included in the application s Tab 5. The applicant indicates that while it does not have a maternal fetal medical specialist, it has a candidate for the position with appropriate training, credentials, and experience and negotiations for him to join our active staff are currently in progress. 16

17 (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. Gulf Coast Medical Center s current newborn nursery and Level II nursery are now supervised by Jana Crosby a registered nurse with appropriate training, including the Neonatal Resuscitation Program (NRP) of the American Heart Association, STABLE (Sugar, Temperature, Assisted Breathing, Blood Pressure, Lab Work, and Emotional Support to Family), PALS (Pediatric Advanced Life Support) and PEARS (Pediatric Emergency Assessment Recognition and Stabilization). The applicant anticipates that Ms. Crosby or a registered nurse with similar training and experience will continue to supervise the nursing staff of the Gulf Coast Medical Center NICU following implementation of the Level III component. All nurses assigned to the Gulf Coast Medical Center NICU are and will continue to be registered nurses. The applicant indicates that there are currently 29 nurses at Gulf Coast Medical Center providing services in the existing Level II NICU. Schedule 6A indicates that the project will require an additional 12.6 FTEs for registered nurses. (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. Gulf Coast states that all nursing staff are certified in the Neonatal Resuscitation Program of the American Heart Association and all future nursing staff will be similarly credentialed prior to assignment in the NICU. All of the RNs and respiratory therapists who work in the planned Gulf Coast Medical Center NICU are and will continue to be appropriately trained to assist in ventilation, administer IV 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. Additionally, all relevant NICU staff members will receive training in the STABLE 17

18 (Sugar, Temperature, Assisted Breathing, Blood Pressure, Lab Work, and Emotional Support to Family) program. (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. Gulf Coast Medical Center states it currently complies with this requirement in its Level II NICU and will continue to comply with it in the proposed Level III NICU. The applicant indicates that project will require an additional 4.2 FTEs for respiratory therapists. This is confirmed in Schedule 6A. (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 asserts 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 Gulf Coast Medical Center. Most are performed within the NICU, but CT scans, MRI scans and surgical procedures are transported to the appropriate in-house department. Anesthesia is available, inhouse, within 30 minutes. Gulf Coast Medical Center s clinical laboratory has the capability to perform microstudies. (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. 18

19 The applicant maintains a registered dietician with special expertise in nutritional needs of neonates available to work with the NICU s neonatologists, nursing and social work staff as well as each family to provide dietary planning and nutrition counseling. This service is available during their hospital stay and after discharge. (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. Gulf Coast Medical Center states that the current NICU social workers are familiar with neonatal developmental needs and the resources and needs of NICU families. They make rounds in the unit to ensure that needs are being met within the hospital, and to discuss potential social service needs and referrals for each patient. The social worker helps to ensure that the appropriate arrangements are made in preparation for discharge, matching the needs of the neonate and family with appropriate community resources. (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. Gulf Coast Medical Center states in-hospital services for infants identified as being at-risk for developmental disabilities are provided to NICU patients by the unit consultant developmentalist, a developmental psychologist, physical therapist or other specialist as necessary. In-hospital interventions for infants includes, as necessary, medical consultation and therapies, family support and caregiver education. 19

20 The applicant maintains that developmental assessments are provided to babies at high developmental risk. Priority is given to babies eligible for the state s early intervention program, but assessments will be available for all NICU babies with physician s referral. Gulf Coast Medical Center states that the developmentalist, parents, neonatal nurse clinician and the NICU discharge teamwork together to identify developmental needs of babies at discharge and make referrals as necessary to ensure those needs are met. (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. Gulf Coast Medical Center states that one of the RNs assigned to the NICU has the designated responsibility for coordinating discharge planning for each neonate, with interdisciplinary support from other team members, to ensure that an optimal discharge plan is developed and implemented. The resulting discharge plan addresses the infant s medical and social support needs following discharge in terms of rehabilitative therapies (PT, OT and/or speech therapies), breastfeeding, family support and counseling and referral to community resources as needed. 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. Gulf Coast Medical Center states that Mary Bailey Mehta, M.D., a board-certified pediatric cardiologist, is currently on the active staff and is available for consultation at all times. Dr. Mehta has held board-certification in pediatric cardiology since

21 (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. Gulf Coast Medical Center asserts that the nurse to neonate ratio will be at least 1:2 for the Level III component of the Gulf Coast Medical Center NICU. All professional nursing staff assigned to the NICU at Gulf Coast Medical Center are and will continue to be registered nurses. Schedule 6A indicates 12.6 FTEs for RNs for the first year of operation and 12.6 in the second year of operation. The applicant projects to have a 3.3 average daily census (ADC) in year one and an ADC of 3.7 in year two. 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. Both the existing Level II NICU beds and the proposed Level III beds will be housed in a new 18-bed NICU to be constructed as part of a major critical care renovation and expansion project. The per bed area will be the same for both Level II and III beds and will greatly exceed the 80 square foot standard. The applicant asserts 21

22 that both the electrical and the medical gas requirements will be met and/or exceed requirements. Additionally, provisions for all necessary equipment have been made, and appropriate costs are included in the project cost reflected in Schedule 1. Existing and new equipment lists are included in Tab 7. 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. Gulf Coast Medical Center states that it participates in a 24-hour EMS patient transportation system operated by Bay Medical Center through contractual arrangement with Bay County. Gulf Coast Medical Center transferred 27 newborn infants to other hospitals for care during calendar year 2010 with their primary destinations being Shands Gainesville and Sacred Heart Hospital in Pensacola. Both Shands and Sacred Heart operate their own independent transport helicopters and most neonatal transports are via their vehicles. The NICU transport team consists of at least one neonatal RN and one respiratory technician (RT) qualified for transport duty. The applicant states that designated transport team members are available within 30 minutes or less on a 24-hour basis to perform transport services. 22

23 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. The applicant maintains that this standard is not applicable to the proposed project. However, Gulf Coast Medical Center maintains transfer agreements with Shands Gainesville, Sacred Heart Hospital and Tallahassee Memorial Hospital. The applicant indicates that these transfer agreements are expected to remain in effect following implementation of the proposed Level III NICU at Gulf Coast Medical Center. 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, Gulf Coast Medical Center 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 systems immediately and seamlessly upon project initiation. 23

24 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. Gulf Coast Medical Center 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 five county service area because none presently exist. The applicant reiterates some of its earlier arguments for need of the proposed facility. Gulf Coast Medical Center notes that Level III utilization at TMH (the only Level III NICU service in District 2) averaged 75 percent, slightly below the 80 percent threshold. However, the applicant lists several mitigating factors against this fact and in favor of the application. Gulf Coast contends that any impact of the proposed program upon an existing provider is expected to be small. Gulf Coast Medical Center does not contend that the quality of care provided by existing providers of Level III NICU services is a rationale for approval. However, the applicant maintains that the project will improve quality in the service area by reducing the number of critically ill neonates who must be transported and reducing the instances of separation of hospitalized mothers and critically ill neonates. Gulf Coast Medical Center 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. 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. Gulf Coast Medical Center states that it opened its doors on January 3, 1977 as a 150-bed state-of-the-art acute care hospital. Currently, the hospital is a 176-bed (166 acute care and 10 Level II NICU beds) regional referral center that is nationally ranked for the quality of health care provided to its patients every day. Gulf Coast Medical Center offers a full range of patient care and ancillary services, directly or through referral, consultation, or contractual arrangement. 24

25 25 CON Action Number: Gulf Coast Medical Center is accredited by the Joint Commission and holds Joint Commission certification in several programs. The Agency has also recognized the applicant as a primary stroke center. Gulf Coast Medical Center states it recognizes the importance of patient safety and details several quality and patient safety initiatives it has undertaken. These initiatives are listed below: Airstrip OB Electronic Health Record PatientKeeper Vitals Capture Picture Archiving and Communications System Voice Recognition Methicillin-Resistent Staphylococcus Aureus Electronic Medication Bar Coding Nation s First Infant Screening Program From an organizational perspective, the proposed Level III NICU service at Gulf Coast Medical Center will be incorporated into the applicant s existing care delivery and performance improvement structure. The purpose of this plan is to ensure that the governing body, medical staff and professional service staff demonstrate a consistent mission to deliver safe, effective, optimal patient care and services in an environment of minimal risk. The NICU quality/performance improvement plan establishes: Priority Focus Area or Processes for Improvement Measurement or Indicators Benchmark or Standard Data Collection Process & Responsibility Time Frames for Measurement Reporting Processes The proposed Level III NICU will be integrated into a planned new 18-bed NICU at Gulf Coast Medical Center to be constructed as part of a larger critical care renovation and expansion project at the hospital. The applicant contends that the Level III program will greatly enhance continuity of care, reduce the necessity for transfers out of the local service area, and will help meet the two-hour access standard. Gulf Coast Medical Center maintains that is has an extensive body of experience, resources, proven ability and reliability in the operation of its facility and programs, and in the provision of quality health care in the service area. The applicant contends that its proven ability to provide superior quality health care in its existing hospital operations, particularly the existing NICU, will also contribute to the ongoing success and effectiveness of the proposed Level III NICU program.