1. (1) The hematopoietic progenitor cell procurement service and hematopoietic progenitor cell processing facility shall keep records which indicate that a quality assurance program is maintained in the following areas:

   1. (i) preventive maintenance, periodic inspections and testing for proper operation of equipment;
   2. (ii) monitoring of all temperature-controlled spaces and equipment to ensure proper performance;
   3. (iii) validation of microprocessor-controlled equipment and associated software, including test plan protocols, results of parallel testing, and supervisory review; and
   4. (iv) validation of hematopoietic progenitor cell processing and testing methodologies.
2. (2) Hematopoietic progenitor cell processing, laboratory and storage facilities shall be maintained in a clean and orderly manner, and shall be of suitable size, construction, and location to assure product and personnel safety.
3. (3) All reagents and solutions shall be in-date, stored properly, and labeled to indicate identity and, as appropriate, titer, strength or concentration, recommended storage requirements, preparation and/or expiration date, and other pertinent information. All such materials shall be removed from use on the expiration date. Materials of substandard reactivity and deteriorated materials shall be discarded regardless of expiration date.
4. (4) All specimens accompanying the collected hematopoietic progenitor cells shall be sufficiently stable to provide accurate and precise test results suitable for clinical interpretation. The hematopoietic progenitor cell procurement service shall ensure that specimens are collected, preserved and transported to the laboratory in such a manner as to meet this requirement. Specimens for analysis shall be identified fully and accessioned in a log book. The accessioning system shall be designed to allow tracing of the hematopoietic progenitor cells to a specific donor, and to identify the date and, if applicable, the time of retrieval.

5. (5) Current standard operating procedure manuals specific to the facility shall be available at all times in the immediate work area of personnel engaged in retrieval, processing, testing, storage, distribution, or other hematopoietic progenitor cell procurement activity. There shall be a written protocol for all procedures performed. Manuals shall contain a protocol for development, maintenance, and periodic review of standard operating procedures by facility personnel and management staff. Procedure manuals shall have the following features:

   1. (i) a standardized format for procedures;
   2. (ii) a system of numbering and/or titling individual procedures;
   3. (iii) a clearly written description of purpose for each procedure;
   4. (iv) a reference section listing appropriate scientific literature and industry and/or corporate standards espoused by the hematopoietic progenitor cell procurement service and/or processing facility;
   5. (v) clearly defined areas of employees or technical staff responsibility by position/title;
   6. (vi) documented approval of procedures and procedural modifications, including annual review by the director of the hematopoietic progenitor cell procurement service and/or processing facility, or authorized supervisor;
   7. (vii) instructions for the completion of reports and forms, including examples;
   8. (viii) effective date and date of review for each procedure; and
   9. (ix) a system for archiving earlier versions of procedures and forms.
6. (6) The policies and procedures specified in the procedure manual shall be followed at all times. If deviations or deficiencies are identified, appropriate corrective action shall be taken and documented.
7. (7) The director of the hematopoietic progenitor cell procurement service and/or processing facility shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of the hematopoietic progenitor cell banking services. Included in the program shall be systems for evaluating errors, and designing, implementing and documenting corrective action for any deficiencies identified. Quality assurance deficiencies shall be documented, and evidence shall be available that any operational or procedural problems are reported to supervisory personnel in a timely manner, and that corrective action is implemented, documented and subsequently followed up.

8. (8) The director of the hematopoietic progenitor cell procurement service and/or hematopoietic progenitor cell processing facility shall be responsible for developing policies, procedures and/or standards for the qualifications, training, certification and continuing education of technical staff. Documentation of compliance with this requirement and with the policies developed shall be maintained.

   (b) Safety.

9. (1) The hematopoietic progenitor cell procurement service and/or processing facility shall implement written safety and infection control policies and procedures to ensure protection from unnecessary physical, chemical and biological hazards, as follows:

   1. (i) Decontamination and disposal techniques for regulated medical waste shall be utilized. All hazardous and regulated medical waste materials shall be handled, stored and discarded pursuant to Part 70 of this Title.
   2. (ii) If sterilization equipment is used, the pressure, temperature and duration of each cycle shall be recorded, and such records maintained for one year. For each run, these parameters shall be within the manufacturer's recommended operating standards. If any one or more of these parameters fall(s) outside the manufacturer's standards, all material shall be resterilized. Chemical, biological and physical detection systems should be used in conjunction with these other measurements of performance.
   3. (iii) Eating, drinking, smoking, or the application of cosmetics or contact lenses shall not be permitted in work areas. Refrigerators or freezers used for storing specimens or reagents shall not be used for any other purpose.
   4. (iv) Gloves and laboratory coats, gowns or other protective clothing shall be worn as necessary while handling blood specimens or hematopoietic progenitor cell tissue. Such protective clothing shall not be worn outside the work area and shall be disposed of in an appropriate receptacle.

10. (2) The hematopoietic progenitor cell procurement service and/or processing facility shall have written policies and procedures in the following areas:

    1. (i) infection control;
    2. (ii) biosafety;
    3. (iii) chemical and radiological safety;
    4. (iv) emergency response to worksite accidents; and
    5. (v) medical waste disposal.
11. (3) The safe collection of peripheral blood hematopoietic progenitor cells by apheresis shall be the responsibility of the medical director of the apheresis service. Collection shall be performed in full compliance with section 58-2.15 of this Part.
12. (4) Hematopoietic progenitor cell transplantation facilities shall report suspected cases of infectious disease transmission in recipients to the hematopoietic progenitor cell bank providing the tissue.
13. (5) The hematopoietic progenitor cell bank shall have a written procedure for documenting any errors or accidents in retrieval, testing, processing, storage or disposition of hematopoietic progenitor cells that may affect the safety of the cells, and for reporting such errors or accidents to the medical advisory committee of the bank. If the error or accident is detected after issuance of the cells, the error or accident shall be reported to the receiving facility immediately upon detection by the distributing facility. All errors with the potential for serious adverse effects on the recipient shall also be reported to the department's Wadsworth Center within seven calendar days of discovery.

(a) Quality assurance.