641—203.9 (135) Obstetrical services and neonatal intensive care unit standards.
	 203.9(1) Purpose and scope.
	  a.   	 These standards are measures of some of those criteria 1(a to q) and 3 found in Iowa Code section 135.64. Criteria which are measured by a standard are cited in parentheses following each standard.
	  b.   	 Certificate of need applications for new institutional, or changed institutional health services, which are to be evaluated by the standards in this section, are those applications to:
	 (1) 	 Offer new, discontinue, or change the level of perinatal services;
	 (2) 	 Construct, develop, offer new, modernize, replace, renovate or relocate neonatal intensive care services;
	 (3) 	 Expand bed capacity in neonatal intensive care units.
	 203.9(2) Definitions.
	  a.   	 “Perinatal services” means the facilities, equipment and personnel which provide fetal, neonatal, and maternal care from the first indication of pregnancy up through and including birth and to the time when mother and infant are in stable health. Perinatal services in acute care facilities are classified by the Iowa department of public health into three levels of centers. For detailed descriptions of what constitutes levels of obstetrical and neonatal services, reference Standards for Perinatal Centers (most recent edition), Iowa department of public health.
	 (1) 	 Level I perinatal centers are hospitals whose function it is to provide neonatal nursery and obstetrical services for uncomplicated newborn and maternity patients. Certain level I centers with large numbers of births may offer some of those neonatal and obstetrical services associated with regional level II perinatal centers.
	 (2) 	 Regional level II perinatal centers are designated hospitals whose responsibility is to provide care for the majority of complicated/high-risk fetal, neonatal and maternal patients in their areas. Regional level II referral area facilities have:
	  1. 	 A defined referral area;
	  2. 	 An educational outreach program; and
	  3. 	 Staffing for maternal and neonatal emergency transport in the referral area.
Regional level II perinatal centers also provide level I neonatal and obstetrical services.
	 (3) 	 Level III perinatal centers are designated hospitals whose priority responsibility is to provide tertiary care for all types of fetal neonatal and maternal illnesses and abnormalities. Tertiary responsibilities are to provide:
	  1. 	 Consultation to level I and level II centers;
	  2. 	 Transportation from level I and level II centers;
	  3. 	 Continuing education and training for level I and level II centers.
Level III centers also provide level I and level II perinatal services.
	  b.   	 “Obstetrical unit” means the labor, delivery, post partum, auxiliary facilities and primary care nursery unit in any perinatal center. The intensity of obstetrical services differs between the three levels of perinatal centers. Intensity means the kinds of personnel and equipment, and to a lesser extent physical facilities available, and is related to the number of births occurring at a facility. Auxiliary facilities include, but are not limited to, scrub facilities, equipment rooms, formularies, sterilization facilities, and drug distribution stations.
	  c.   	 “Neonatal intensive care unit” means a nursery unit for neonates who are critically ill or of extremely high risk.
	 203.9(3) Availability.
	  a.   	 Relationship of perinatal centers to Iowa department of public health’s perinatal standards committee.
	 (1) 	 Each hospital submitting an application shall identify in writing the level of care at which the state health plan classifies that hospital’s perinatal services, as identified by the Iowa department of public health’s perinatal standards committee.
	 (2) 	 In addition to meeting the standards which follow, each applicant which seeks to change the level of care at which the state health plan classifies its perinatal services should submit to the department, during the letter of intent period, additional information in which the applicant describes the degree of conformance with the perinatal standards for the level of care that it seeks to deliver.
	 (3) 	 Upon receipt of the additional information, the staff to the health facilities council shall seek a recommendation of the perinatal standards committee as to the applicant’s conformance to the standards.
	  b.   	 Minimum utilization—neonatal intensive care units. Each regional perinatal center service area should have no more than four neonatal intensive care beds per 1,000 live births.
	  c.   	 Expansions. Applications for expanding or starting new neonatal intensive care units should not receive approval unless they have received the endorsement of the Iowa department of public health’s perinatal standards committee. Such endorsement should be accompanied by an analysis of the impact the new beds will have on the occupancy rates of other neonatal intensive care units in the same referral area.
	 203.9(4) Costs. See financial and economic feasibility standards, 641—203.8(135).
	 203.9(5) Accessibility.
	  a.   	 Travel time to a level I obstetrical unit should not exceed 30 minutes for 80 percent of the population served by that unit.
	  b.   	 Services should be provided regardless of ability to pay, in consideration of those programs available in the state which serve the medically indigent.
	 203.9(6) Quality. Facilities should meet those Standards for Perinatal Centers (most recent edition), Iowa department of public health, for the levels of care which they provide.
	 203.9(7) Continuity. Facilities should meet those Standards for Perinatal Centers (most recent edition), Iowa department of public health, for the levels of care which they provide.
	 203.9(8) Acceptability. Facilities with neonatal and obstetrical services shall document a willingness to observe and respect the rights of patients. Provisions for counseling services shall be available.
This rule is intended to implement Iowa Code section 135.64.