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 58-2.7 - Immunohematology testing

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Blood
					 specimens intended for pre-transfusion testing shall be labeled at the
					 patient's side at the time of collection. Such labelling shall include the
					 patient's name, patient's identification number, and date of collection.
					 Identification of the person collecting the specimen shall be
					 recorded.
(b) All tests, including,
					 but not limited to, ABO and Rho(D) grouping, antibody detection and
					 identification, and compatibility testing, shall employ methods, techniques or
					 procedures which have been approved or recommended for the particular reagent
					 in use by the F.D.A or the American Association of Blood Banks, and which have
					 been demonstrated to be effective in a manner acceptable to the department, in
					 conformance with generally accepted laboratory principles. All grouping
					 antisera, reagents, devices, methods, and procedures for blood unit processing
					 or transfusion-related testing shall be approved by the F.D.A. or conform to
					 the recommended minimum requirements of the F.D.A.
(c) All reagents shall be stored in labeled
					 containers under conditions appropriate for each reagent as directed by the
					 manufacturer and shall be removed from use after their expiration date. The
					 reactivity and specificity of each reagent shall be determined whenever a new
					 lot is employed. All methods shall conform to manufacturers' instructions
					 unless otherwise approved by the department.
(d) Negative controls run on each day of use
					 are not required for anti-human globulin and antibody screening cells, provided
					 manufacturers' instructions are followed. New lots of reagents shall be
					 thoroughly evaluated, but antibody identification cell panels need not be
					 tested with a known antibody. All test procedures to be used shall be
					 determined by the blood bank director and shall be documented in the standard
					 operating procedure manual. If no negative reactions are observed on a given
					 test run, an investigation shall be performed and controls run. All quality
					 control records shall be retained for five years.
(e) Centrifuges used for testing of red blood
					 cell agglutination shall undergo revolutions per minute (RPM) and timer checks
					 quarterly. Functional calibration that determines optimal centrifugation
					 conditions shall be performed prior to initial use, after adjustments or
					 repairs, and at least annually thereafter, and shall be documented. The
					 procedure shall specify the speed and duration of centrifugation to be used. A
					 microscope shall be located in the work area designated for immunohematology
					 testing, if use of a microscope is specified by the facility's standard
					 operating procedure manual or by a test kit manufacturer's package insert.
					 Microscopic examination shall be performed for red blood cell agglutination
					 tests whenever indicated for the procedure in use.