New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.8 - Standard operating procedures

Current through Register Vol. 46, No. 28, July 10, 2024
(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 in the 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.
(a) 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 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.