- (a) Records. Donor records shall be maintained in accordance with applicable federal and state law, including 21 CFR 606.160 and 21 CFR 640.72, as amended from time to time. Blood collection facilities shall comply with the requirements of Section 36a-701b of the Connecticut General Statutes.
- (b) Confidentiality. Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall comply with the requirements of section 36a-701b of the Connecticut General Statutes, and with all applicable federal and state laws regarding the confidentiality, privacy and security of donor records and personal information, including health information.
- (c) Adverse events. Records of donor reactions occurring on-site at the blood collection facility licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies, or reported to the facility after the donor has left the facility, shall be kept in a manner that complies with the requirements of 21 CFR 640.72, as amended from time to time.
- (d) Reporting. Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall comply with all requirements in 21 CFR 640.73, as amended from time to time, governing reporting of adverse events. Fatalities confirmed to be caused by blood donation shall be reported to the department, and to the United States Food and Drug Administration in accordance with 21 CFR 606.170(b), as amended from time to time.
- (e) Reportable diseases. Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall comply with the reporting requirements under section 19a-215 of the Connecticut General Statutes.
- (f) If an error or accident occurs and any blood or blood component not suitable for any use is released for use, immediate effort shall be made to locate and destroy all such blood or blood components. All actions taken to address an error or accident shall be documented in writing.
(Effective March 19, 2025)