Section 640.85  Exceptions to Part 640

a)         A hospital may request an exception to the standards of care set forth in this Part in accordance with this Section. Exceptions are not intended to circumvent Level designations.  The hospital or the APC may seek the advice and consultation of the Department, as well as the PAC, in regard to the requirements for an exception.

b)         Exceptions to the standards of care set forth in this Part may be granted when the hospital requesting an exception demonstrates that the resources and quality of care (outcomes) are substantially equivalent to the resources and quality of care for a facility at the next highest level of designation, as indicated by the resource requirements set forth in this Part.  If the hospital and its APC agree on the proposed exception, a proposed letter of agreement shall be submitted to the Department for review and approval. The Department's review will be based on compliance with this Part, patient care needs, current practice, outcomes, and geography in the regional perinatal network. 

c)         If the hospital and its APC do not agree on any aspect of the proposed exception, the hospital or the APC shall consult the Subcommittee on Facility Designation (SFD) of the PAC. 

d)         The following information shall be submitted to the SFD:

1)         A proposed letter of agreement (unsigned);

2)         The curriculum vitae for all directors of patient care, i.e., obstetrics, neonatal, nursing (obstetrics and neonatal);

3)         Appendix A of this Part (fully completed);  and

4)         A letter from the APC that includes the following information:

A)        The exceptions being requested;

B)        Information demonstrating that the quality of care (outcomes) of the hospital is substantially equivalent to the standards of this Part for the next highest level of designation for the proposed exceptions;

C)        A description of the monitoring system used when consultation  between the attending physician at the hospital and the physician consultant at a higher level hospital determines that a mother or newborn infant should remain in the hospital rather than being transferred to the higher level hospital;

D)        A description of any arrangements made between the hospital and the APC to seek or ensure quality improvement;

E)        A copy of the hospital's Maternity and Neonatal Service Plan (Subpart O of the Illinois Hospital Licensing Requirements); and

F)         The PAC's recommendation concerning the exception.

e)         The medical co-directors of the APC (or their designees) and the medical directors of obstetrics and maternal and newborn care and a representative of hospital administration from the applicant hospital shall participate (either in person or electronically) in the SFD's review of the application.

f)         Exceptions agreed to between hospital and the SFD shall be defined in a proposed letter of agreement and submitted to the Department for review and  approval. The Department's review will be based on compliance with this Part, patient care needs, current practice, outcomes, and geography in the regional perinatal network. 

g)         If the SFD is not able to make a decision on the exception, the SFD shall submit the request for an exception to the Department, including all of the information submitted to the SFD in accordance with subsection (d) and the SFD's recommendation concerning the exception.

h)         The Director of Public Health shall make the final decision regarding approval of the exception and the letter of agreement.  The Director's decision shall be based upon the recommendations of the APC and the SFD and the documentation required in subsection (d) to determine the facility's compliance with this Part.  The Director's decision may be appealed in accordance with Section 640.45.  The Department shall inform the hospital, the APC and the SFD of the decision.

(Source:  Added at 35 Ill. Reg. 2583, effective January 31, 2011)