1. (1) Records shall document that the following quality control procedures are in place at the tissue bank, except for a limited tissue procurement service:

   1. (i) preventive maintenance, periodic inspections and testing for proper operation of equipment, including annual calibration of thermometers used to monitor the temperature of tissue in storage, against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against and found to be in agreement with an NIST-certified thermometer;
   2. (ii) monitoring of all temperature-controlled spaces and equipment to assure proper performance;
   3. (iii) validation of computer systems, microprocessor-controlled equipment and associated software;
   4. (iv) validation of processing and testing methodologies; and
   5. (v) supervisory review of test results prior to labeling of the tissue.
2. (2) 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 tissue 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 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 for testing accompanying the retrieved tissue shall be sufficiently stable to provide accurate and precise test results suitable for clinical interpretation. The tissue bank 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 trace the tissue to a specific donor and to identify the date and, if applicable, the time of retrieval.
5. (5) Control samples and standards shall be assayed regularly in order to validate test results on patient samples and to monitor reagents, operating characteristics of instruments, and accuracy of volumetric equipment. The frequency required for such testing shall be determined by the nature of the testing. Records of test procedures, reagents, calibrations, and results with control samples and standards shall be maintained and be available at all times for use by processing laboratory personnel and inspection by the department. As appropriate, these records shall document the precision required for every method, automated or manual, and its restandardization schedule. Control limits for standards and reference samples shall be recorded and shall indicate when test results are outside acceptable limits. Values for quantitative assays shall be reported only if the analytical run of which they are a part is an acceptable run as determined by a protocol approved by the laboratory director. If the analytical error exceeds limits established by the laboratory's quality control program, remedial action shall be taken and documented, and the patient specimen, if available, retested. Whether or not the specimen is available for retesting, the initial result shall be reported as invalid.

6. (6) Current standard operating procedure manuals or other procedural guides specific to the facility shall be available at all times in the immediate work area of personnel engaged in tissue retrieval, processing, testing, storage and distribution activities. There shall be a written procedure for each tissue collection, processing, storage and distribution activity performed at the facility. Manuals shall contain a protocol for writing, maintaining and periodic review of standard operating procedures by user personnel and management staff. Procedure manuals shall have the following features:

   1. (i) a standardized format;
   2. (ii) a system of numbering and/or entitling 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 tissue bank;
   5. (v) clearly defined areas of personnel responsibility by title;
   6. (vi) documented approval of procedures and procedural modifications, by the tissue bank director, and annual review by the tissue bank director or authorized supervisor;
   7. (vii) instructions for the completion of reports and forms, including examples;
   8. (viii) authorship and effective date, and date of review for each procedure; and
   9. (ix) a system of archiving earlier versions of procedures and forms.
7. (7) The policies and procedures specified in the current standard operating procedures manual shall be followed at all times. If deviations or deficiencies are identified, appropriate corrective action shall be taken and documented.

8. (8) The tissue bank director shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of the banking activities conducted. Included in the program shall be a system for designing and implementing corrective action for any problems identified. Quality assurance deficiencies shall be documented, and evidence shall be available that problems are reported to supervisory personnel in a timely manner and that corrective action is implemented, documented and subsequently followed-up.

   (b) Safety.

   The tissue bank shall implement written safety and infection control policies and procedures to ensure protection from unnecessary physical, chemical and biological hazards.

9. (1) Decontamination and disposal techniques for regulated medical waste shall be utilized. All hazardous and regulated waste materials shall be handled, stored and discarded pursuant to Part 70 of this Title, or in the case of out-of-state banks, in accordance with the hazardous waste disposal requirements of the state in which the disposal occurs.
10. (2) If autoclave equipment is used for sterilization, 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 outside the manufacturer's standards, all material shall be reautoclaved. Chemical, biological and physical detection systems should be used in conjunction with these other measurements of performance.
11. (3) Eating, drinking, smoking, or the application of cosmetics or contact lenses shall not be permitted in work areas. Refrigerators or freezers used for storing tissue, specimens or reagents shall not be used for any other purpose.
12. (4) Gloves and laboratory coats, gowns or other protective clothing shall be worn as necessary while handling specimens or tissues. Such protective clothing shall not be worn outside the work area and shall be disposed of in an appropriate receptacle.

13. (5) A tissue bank performing tissue processing or laboratory testing shall have written policies and procedures in the following areas:

    1. (i) infection control;
    2. (ii) biosafety;
    3. (iii) chemical safety and, if radioactive materials are used, radiological safety;
    4. (iv) emergency response to worksite accidents; and
    5. (v) waste disposal.

(a) Quality assurance.