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 58-2.6 - Collection and handling of blood for subsequent allogeneic or autogeneic transfusion

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
					 Phlebotomy apparatus and blood containers shall be clean, pyrogen-free and
					 sterile. Anticoagulants shall be placed in containers prior to
					 sterilization.
(b) Phlebotomy sites
					 shall be prepared by a procedure found by the department to meet medical
					 standards generally accepted in New York State.
(c) Blood collection systems shall meet the
					 following minimum requirements:
(1) Blood
					 shall be collected under aseptic conditions using an approved closed system or
					 a vented system if adequately protected against contamination.
(2) Anticoagulant solutions shall be sterile
					 and pyrogen-free F.D.A.-approved formulae such as anticoagulant citrate
					 dextrose (ACD) (21-day storage), citrate phosphate dextrose (CPD) (21-day
					 storage), trisodium citrate (48-hour storage), heparin (48-hour storage),
					 citrate phosphate dextrose adenine-1 (CPDA-1) (35-day storage), and other safe
					 and effective formulae and storage periods, of such length as to assure the
					 blood's continued effectiveness for transfusion and retention of its safety,
					 purity and potency, as approved by the department, may be employed.
(3) Labeling requirements.
(i) For allogeneic collection, the container
					 and the attached pilot blood specimens shall be legibly labeled at the time of
					 collection with the associated unit's identification code. The container label
					 shall indicate the date of expiration. As soon as available, the results of ABO
					 and Rh grouping tests shall be affixed to the component containers.
(ii) With the exception of units collected in
					 an operating room which never leave the immediate proximity of the patient, for
					 autogeneic collection, the following information shall appear on a label or tag
					 attached to the blood container:
(a) the
					 identification of the collecting facility;
(b) the patient's name and if available, the
					 name of the hospital where the patient is to be transfused and the patient's
					 hospital registration number or, if unavailable, social security number, birth
					 date or similar identifying information. This tag shall be removed if the unit
					 is subsequently used for allogeneic transfusion;
(c) ABO and Rh group;
(d) date of expiration;
(e) if the unit does not qualify for
					 allogeneic transfusion, a prominent label to read " For autologous use only" or
					 similar wording;
(f) an autogeneic
					 unit from a donor who has tested positive or reactive on any of the tests
					 required in section
					 58-2.3(a) 
					 of this Subpart within the previous 30 days shall be labeled as a biohazard
					 unless confirmatory testing has been negative. The exterior of the shipping
					 container shall not contain any information identifying the donor;
					 and
(g) a label bearing the donor
					 classification statement "Autologous donor" shall be permanently affixed to the
					 unit.