1. (a) Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall comply with applicable federal, state and local laws.
2. (b) Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall comply with the requirements of 21 CFR 607.7, as amended from time to time, and all requirements for donor eligibility, blood donation including apheresis, and donor notification in 21 CFR 630 and 21 CFR 640, as amended from time to time.
3. (c) All reference laboratories utilized by a blood collection facility licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall hold a CLIA certificate or state license or both, as applicable, and shall comply with the requirements of 21 CFR 607.7, as amended from time to time.

4. (d) Policies and procedures setting forth minimum standards of operation shall be provided to the department for review upon initial or renewal application and on request. Such policies and procedures shall be available to facility personnel for use in areas where procedures are performed. Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall develop and implement such policies and procedures in writing to include, but not be limited to, the following:

   1. (1) Policies and procedures for donors, including but not limited to:

      1. (A) Donor education including donation process and donation risks;
      2. (B) Donor consent in language that is clear and accessible;
      3. (C) Donor care including privacy, confidentiality, response to adverse events, and the provision of emergency care;
      4. (D) Donor eligibility including health assessment and donation limits;
      5. (E) Post-procedure instructions for donors including potential adverse events;
      6. (F) Donor notification in the event of abnormal findings and test results;
      7. (G) Procedures for donors to file complaints with a blood collection facility licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies; and(H) Procedures for donors to file complaints with the department regarding a blood collection facility licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies.
   2. (2) Documentation and recordkeeping, including confidentiality and retention of donor records.

   3. (3) Staffing, including educational and training requirements, including, but not limited to:

      1. (A) A defined training program to verify the qualifications and ability of all trained persons in accordance with section 19a-36-F5(c)(5) of the Regulations of Connecticut State Agencies;
      2. (B) Policies to identify ongoing training and education needs for personnel who perform activities affecting the quality of blood and blood components and the health and safety of donors;
      3. (C) Records of personnel qualifications and training shall be kept verifying the qualifications of personnel, and to document ongoing training and continuing education of personnel;
      4. (D) Establishment and maintenance of minimum staffing levels; and(E) Staffing plans to ensure that personnel cross-trained in blood collection, specific to the equipment and facility, are available to maintain safe staffing levels in the event of a personnel or donor emergency and to maintain minimum staffing levels established pursuant to subparagraph (D) of this subdivision.
   4. (4) Emergency preparedness including an emergency communications plan to include notification of the director. If the facility operates temporary or mobile locations, the emergency plan shall include such locations.
   5. (5) Medical contingency planning.
   6. (6) Data collection and reporting in accordance with the requirements of section 19a-36-F6 of the Regulations of Connecticut State Agencies.

   7. (7) Quality assurance and infection control in compliance with all federal and state regulatory requirements, including but not limited to:

      1. (A) Quality assurance and process improvement procedures including the competency of personnel, and periodic documented review to assess the effectiveness of such quality assurance and process improvement procedures.
      2. (B) Equipment policies and procedures to ensure appropriate calibration, maintenance and monitoring for health and safety.
      3. (C) Handling and discarding of blood and blood components to meet standards of practice governing safe disposal, including a written procedure for documented review prior to the release and final labeling of blood or blood components.
      4. (D) Labeling.
      5. (E) Contamination. Policies and procedures to prevent contamination and ensure aseptic methods of collection of blood, in accord with CDC standards for infection prevention and control that apply in healthcare settings and which shall include, but not be limited to, changing gloves between donors when conducting phlebotomy procedures.
      6. (F) Errors and adverse events. Policies and procedures regarding errors and adverse events shall include a list of potential adverse events and plans for responding to such events. Such policies and procedures shall ensure the identification, assessment, investigation, documentation, and monitoring of deviations from, or of failure to meet, specified requirements, including adverse donor reactions. The investigation shall, when applicable, include an assessment of the effect of the deviation or failure on donor eligibility and donor and patient safety. The responsibility for review and authority for the disposition of nonconforming blood, blood components, tissue, derivatives, critical materials, and services shall be defined. Adverse events shall be reported in accordance with section 19a-36-F6 of the Regulations of Connecticut State Agencies and in accordance with federal requirements.

   8. (8) Facilities and equipment.

      1. (A) The management, operation, personnel, equipment, sanitation and maintenance of the facility shall be such as to ensure the health, comfort and safety of donors, staff and the public at all times.
      2. (B) Facilities, physical environment, and equipment shall be maintained to provide safe and acceptable standards for handling of human blood and blood components. Blood collection facilities shall maintain at a minimum a pre-donation waiting area, a private donor screening area for confidential donor examinations and questioning, a donor recovery area, lavatory facilities on the same floor, clean and convenient handwashing facilities for personnel, and the proper equipment for conducting testing and apheresis, and for the immediate storage and labeling of blood and blood components until such blood and blood components are tested and qualified as suitable for labeling. The facility shall be designed and constructed to ensure accessibility and confidentiality in accordance with state and federal law.
      3. (C) Any areas of the facility where procedures are performed or blood or blood components are collected shall be kept clean, adequately lighted and ventilated, and shall be of adequate size to ensure the health and safety of donors and staff.
      4. (D) Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall maintain appropriate facilities and equipment for record keeping in accordance with section 19a-36-F6 of the Regulations of Connecticut State Agencies.
      5. (E) Equipment shall be adequate and in good order at all times as considered necessary for the proper handling of work for which licensure may be granted. Equipment shall be validated for installation, operation and performance, maintained and repaired, and qualified for its intended use according to the manufacturer’s written instructions, and monitored for compliance with requirements according to a documented schedule. Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall maintain, at a minimum, emergency equipment for resuscitation and defibrillation.
5. (e) Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall maintain written documentation that each person employed is fully trained in the policies and procedures setting forth minimum standards of operation as required pursuant to this section.

(Effective March 19, 2025)