Section 640.50  Designation and Redesignation of Level I, Level II, Level II with Extended Capabilities, and Level III Perinatal Facilities

a)         The facility shall declare by means of a letter of intent to the Department that it seeks designation as a facility for the delivery of general perinatal care (Level I) or intermediate perinatal care (Level II or Level II with Extended Capabilities) or intensive care (Level III) in one of the Regional Perinatal Networks of the Illinois Perinatal Health Care Program.

b)         The Department shall acknowledge the letter of intent.

c)         The Perinatal Center shall arrange a site visit to the applicant facility. The site visit team for Level I, II, II with Extended Capabilities, and III perinatal facilities shall consist of 5 members: three from the Perinatal Center of the hospital network, including the Directors of Neonatology and Maternal-Fetal Medicine or their designees and a representative of nursing; one representative from the PAC; and one representative of the Department. The site visit team shall review the capabilities of the applicant facility based on the requirements outlined in the letter of agreement between the applicant facility and the Perinatal Center. The site visit team shall complete the Standardized Perinatal Site Visit Protocol (see Appendix A) and Outcome Oriented Data (see Appendix B) and submit these materials to the medical directors of the facility visited for their review and comment within 30 days from the date of the site visit.

d)         The Department shall coordinate the site visit for Perinatal Centers. The team shall consist of 5 members: one Director of Neonatology, Maternal-Fetal Medicine and Nursing from a non-contiguous Center; one representative from the PAC; and one representative of the Department. The site visit team shall complete the Standardized Perinatal Site Visit Protocol and Outcome Oriented Data and submit these materials to the Perinatal Center for their review and comment within 30 days from the date of the site visit.

e)         The complicated site visit report shall then be forwarded to the Department within 60 days from the date of the site visit. Department staff shall be available for technical and administrative consultation concerning the site visit.

f)          The Department, having received the information requested concerning the applicant facility, the site visit report and the letter of agreement between the applicant facility and the Perinatal Center, shall submit these materials to the Perinatal Advisory Committee for review. The applicant facility may request to appear or may be asked to appear before the Perinatal Advisory Committee during its review of the application.

g)         When the information described in Section 640.60 is submitted to the Perinatal Advisory Committee, it shall review the material, and the report of the site visit, for compliance with the Regionalized Perinatal Health Care Code; and shall make a recommendation for approval or disapproval of the facility's application for designation to the Department.

h)         The Department shall review the submitted materials, any other documentation that clearly substantiates a facility's compliance with particular provisions or standards for perinatal care, and the recommendation of Perinatal Advisory Committee, and shall make a recommendation to the Director of Public Health concerning designation of the facility as an affiliated perinatal facility (Level I, Level II, Level II with Extended Capabilities, Level III) to a designated Perinatal Center in the Statewide Regionalized Perinatal Health Care Program.

i)          The Director of Public Health shall make the final decision and inform the facility of the official determination regarding designation. The Director's decision shall be based upon the recommendation of the Perinatal Advisory Committee and the facility's compliance with the Regionalized Perinatal Health Care Code, and may be appealed in accordance with Section 640.45. The Director of Public Health shall consider the following criteria or standards to determine if a facility is in compliance with the Code:

1)         Confirmation of an approved Maternity and Neonatal Service Plan at the level of care for which the facility is seeking designation.

2)         An approved letter of agreement between the applicant facility and its Perinatal Center in accordance with the provisions described in Section 640.70.

3)         A completed Standardized Site Visit Protocol and Outcome Orientated Data report in accordance with the provisions described in Section 640.50(c)-(e).

4)         Other documentation that clearly substantiates a facility's compliance with particular provisions or standards for perinatal care.

5)         Recommendation of Department program staff.

j)          All designations shall be reviewed by the Department every three years or when the Department may deem necessary to assure that the designated facilities continue to comply with the requirements of the perinatal plan. Circumstances which may influence the Department to review a facility's designation other than every three years could include:

1)         When a hospital wanted to expand or reduce services.

2)         Poor perinatal outcomes.

3)         Change in Perinatal Center or Network affiliation.

4)         Availability of human resources to complete Department site visit.

5)         When a Perinatal Center finds and the Department concurs or determines that a hospital is not appropriately participating in Continuous Quality Improvement (CQI) activities and/or the Quality Improvement in Perinatal Program (QIPP).

k)         Existing designations shall be effective until redesignation is accomplished.

(Source:  Amended at 24 Ill. Reg. 12574, effective August 4, 2000)