Chapter 4 - MONITORING MECHANISMSThis chapter outlines the monitoring mechanisms that will be utilized by the Department to ensure that the Intent of the statute is met.
A.Reporting Requirements of Hospitals1. Effective January 1, 1987, when a request for an anatomical gift is made by hospital personnel, the request and its disposition shall be noted in the decedents medical record. The form that shall be utilized to report this request is attached as Appendix A of these rules.2. Hospitals shall report annually to the Department the number of requests for anatomical gifts made and the number of organs retrieved on the Department's supplement to the American Hospital Association's (AHA) Annual Survey of Hospitals. Effective January 1, 1987, hospitals will begin accumulating the Information necessary to develop this annual report. The Internal reporting form for hospitals and the AHA survey supplemental format that shall be used to provide the Department with this information are attached as Appendixes B and C respectively.3. Hospitals shall demonstrate compliance by maintaining a file, available for the Department's Division of Licensing and Certification review by March 1, 1987, Including the following: a. Inter-hospital agreements as specified by 22 MRSA §2910 S ub-§ 3; andb. a training curriculum for training of organ procurement requests.B.Description of Department's Monitoring Mechanism1. Each year the Department's Office of Data, Research, and Vital Statistics staff will compile death certificate information on primary cause of death data (Data Source: International Classification of Diseases, Ninth Revision, or subsequent updates) to identify decedents aged 1 through 55 that would be potential suitable donor candidates. The specific diagnostic classification categories and corresponding International Classification of Diseases numerical code groupings that will be utilized by Department staff for monitoring purposes are listed in Appendix D. 2. Department Division of Licensing and Certification staff will conduct a limited record review in conjunction with the regular periodic licensure-related inspections of the hospital. This review will be limited to a review of the medical records of the decedents that have been Identified as potentially suitable donor candidates. Dependent on the number of records applicable to the facility, either a representative sample or all of the relevant records will be reviewed. This review will be designed to find out whether a request for organ donation in appropriate situations had been made. If applicable, Department staff will consult with hospital staff to examine why donation requests were not made.3. If Department staff discovered that hospital medical staff were not making organ donation requests In appropriate situations, the hospital's medical director/chief of staff and administrator will be notified in writing about the problem. Department staff recommendations on how to remedy the problem will also be made through this correspondence.4. Department staff will periodically analyze the annual reporting requirement data information obtained on the hospital licensure inspections, the Inter-hospital agreements and other relevant information. If, based on an analysis of this information, the Department determines that a major compliance problem exists, then this will be reported to the Human Resources Committee of the Maine Legislature. Any report submitted to the legislature will also include recommendations on how to rowdy these compliance problem(s).C. Effective Date of Regulations. The effective date of these regulations shall be January 1, 1987. C.M.R. 10, 144, ch. 52, 4