1. (a) Source plasma donation centers licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall only perform donor eligibility tests. The performance of any other laboratory testing shall require a clinical laboratory license effective pursuant to section 19a-36-D21 of the Regulations of Connecticut State Agencies.
2. (b) Blood and blood components collected shall be tested according to the requirements of 21 CFR 610.40, as amended from time to time. If the source plasma donation center refers specimens to a reference laboratory located in the state of Connecticut, the reference laboratory shall have a clinical laboratory license effective pursuant to 19a-36-D21 of the Regulations of Connecticut State Agencies. Reference laboratories located outside of the state of Connecticut shall comply with applicable state and federal licensing requirements.
3. (c) All donor eligibility testing shall be conducted by personnel licensed and authorized as required in the state where testing occurs.
4. (d) Source plasma donation centers licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall meet the requirements of 42 CFR 493, Subpart H, as amended from time to time, regarding enrollment in an approved proficiency testing program under the source plasma donation center’s CLIA certificate for each non-waived donor eligibility test conducted.
5. (e) If proficiency testing is required by federal regulation, records of such testing, including results and interpretations, shall be maintained for two years.
6. (f) All reference laboratories utilized by a source plasma donation center licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall hold a federal certificate or license, or state license, or both, as applicable.

(Effective March 19, 2025)