1. (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. Quality control records of total protein determinations shall be maintained to ensure that no donor shall donate source plasma if the total protein determination is outside normal limits.
2. (b) Confidentiality. Source plasma donation centers licensed pursuant to section 19a-36-E2 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.
3. (c) Adverse events. Records of donor reactions occurring on-site at the source plasma donation center licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies, or reported to the center 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. Severe reactions that require the provision of medical attention and fatal reactions shall be reported to the department within twenty-four hours.
4. (d) Reporting. Source plasma donation centers licensed pursuant to section 19a-36-E2 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. Source plasma donation centers licensed pursuant to pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall submit annual reports to the department of all donor complaints filed including documentation of the complaint resolution.
5. (e) Reportable diseases. Source plasma donation centers licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall comply with the reporting requirements under section 19a-215 of the Connecticut General Statutes.
6. (f) If an error or accident occurs and any blood or blood component or source plasma not suitable for any or the intended use is released for use, immediate effort shall be made to locate and destroy all such blood or blood components or source plasma. All actions taken to address an error or accident shall be documented in writing.

(Effective March 19, 2025)