ny-HLT-43-26-00001-P: Prehospital BloodAdministration

I.D. No. HLT-43-26-00001-P PURSUANT TO THE PROVISIONS OF THE State Administrative Pro- cedureAct, NOTICE is hereby given of the following proposed rule: Proposed Action: Amendment of Part 800 of Title 10 NYCRR. Statutory authority: Public Health Law, section 3003-B(4) Subject: Prehospital BloodAdministration. Purpose: Certified ambulance and advanced life support first response services that store, distribute, initiate and administer human blood products. Substance of proposed rule (Full text is posted at the following State website: https://regs.health.ny.gov/regulations/proposed-rule-making ): The proposed rulemaking would amend sections 800.3 and 800.21, and add new section 800.55 to Part 800 of Title 10 of the New York Codes, Rules and Regulations (NYCRR) pertaining to Emergency Medical Services. Section 800.3 is updated to include new definitions of the terms “blood service practitioner”, “blood products”, “blood derivatives”, “remote stor- age”, “on-site storage”, “cooler”, “cross-matching”, “prehospital blood administration service”, “interfacility blood administration service”, blood program control agent”, “type and screen”, “adverse event”, “patient identifier”, “blood service authorization”, “blood administration service, “blood bank”, and “interfacility transfer”. Section 800.21(q) is amended to update reporting requirements and the reporting process. A new section 800.55 is added, entitled “Prehospital and Interfacility BloodAdministration.” Section 800.55(a) is added to highlight the authority of the Department of Health in approving certified ambulance services and advanced life support first response services to administer blood in the pre-hospital or interfacility settings. Section 800.55(b) is added to provide the requirements for initial and renewal applications to administer blood in the pre-hospital or interfacility settings. Section 800.55(c) is added to detail requirements for Blood Service Practitioner Qualifications and Certifications. Section 800.55(d) is added to provide requirements for adverse event reporting. Section 800.55(e) is added to provide the framework for the storage of blood products. Rule MakingActivities Section 800.55(f) is added to detail requirements for warming devices used for blood products. Section 800.55(g) is added to outline blood administration service requirements. Section 800.55(h) is added to provide compliance requirements for blood administration services. Section 800.55(i) is added to provide details on possible suspension or revocation of a blood administration service authorization. Text of proposed rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov Data, views or arguments may be submitted to: Same as above. Public comment will be received until: 60 days after publication of this notice. This rule was not un