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Title: Section 58-2.8 - Standard operating procedures

Effective Date


58-2.8 Standard operating procedures.

(a) 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 inthe collection, processing, testing, storage, distribution and administration of blood, blood components or derivatives for autogeneic or allogeneic use, and for therapeutic, prophylactic or diagnostic purposes. There shall be a written protocol for all procedures 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) a standardized format;

(2) a system of numbering and/or entitling individual procedures;

(3) a clearly written description of purpose for each procedure;

(4) a reference section listing appropriate scientific literature;

(5) clearly defined areas of personnel responsibility by title;

(6) documented approval of procedures and procedural modifications by the director, and annual review by the director or authorized supervisor;

(7) instructions for the completion of reports and forms, including examples;

(8) effective date and date of review for each procedure; and

(9) a system of archiving earlier versions of procedures and forms.

Discontinued procedure documents and forms shall be retained and be available for inspection for at least seven years. Dates of initial use and discontinuance shall be recorded.

(b) The standard operating procedure manual shall include a written procedure for documenting errors or accidents in collection, testing, processing, storage or distribution that may affect the safety or purity of any product, or health of the donor or recipient. All such errors and accidents not detected prior to product distribution shall also be reported to the department's Wadsworth Center within seven (7) calendar days of discovery and, if required, to federal authorities.

(c) The standard operating procedure manual shall include written policies and procedures regarding the following, for activities performed at the site:

(1) use and maintenance of blood warming devices;

(2) type of infusion sets and filters for all components;

(3) issuance of components, which must include visual inspection prior to issuance;

(4) type of personnel authorized to issue components;

(5) for collecting facilities, obtaining blood or components from other institutions during emergency situations;

(6) all transfusion-related testing, prenatal testing, and neonatal testing;

(7) prompt evaluation of reported transfusion reactions and other adverse events;

(8) emergency release of uncrossmatched blood, which must include compatibility testing performed after release;

(9) method validation requirements;

(10) professional qualifications of personnel who may collect blood specimens for pretransfusion testing;

(11) specimen and labeling requirements for pretransfusion samples;

(12) release of blood and blood components to limited transfusion services and ambulance transfusion services; and

(13) administration of blood components, including prevention of transfusion reactions.

(d) The policies and procedures specified in the standard operating procedure manual shall be followed at all times. If deviations are identified, appropriate corrective action shall be taken and documented.

(e) The blood bank director or the director of transfusion services shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of standard operating procedures in the performance of blood bank and transfusion service activities. 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 the appropriate individuals in a timely manner and that corrective action is implemented and subsequently followed-up.


VOLUME A-1 (Title 10)