California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 1 - PRODUCTION AND DISTRIBUTION OF BIOLOGICS › Article 9 - PREPARATION AND DISTRIBUTION OF WHOLE BLOOD (HUMAN) › Section 997 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
As used in this article:
(a) Blood Bank is a medical facility designed,
						equipped, and staffed to procure, to process, to store, or to distribute human whole
						blood or blood derivatives for transfusion purposes.
(b) For implementation of these regulations, a
						blood bank depository also is designated as a transfusion service.
A transfusion service shall be a component of a clinical
						  laboratory holding a license in accordance with the provisions of Chapter 3
						  (commencing with Section
						  1200) Division 2 of the Business and
						  Professions Code, or such other place where services essentially equivalent are
						  maintained as determined by the department.
A transfusion service shall be responsible for all functions
						  related to storage and preparation of blood for transfusion, except those activities
						  requiring a biologics license, in accordance with the Health and Safety Code,
						  Division 2, Chapter 4 (commencing with Section
						  1600).
Institutions which fulfill criteria for both a clinical
						  laboratory license and a biologics license may maintain the combined services of a
						  blood bank and a transfusion service.
(c) Blood collection center is a stationary
						auxiliary to a blood bank which is designed, equipped and staffed to procure human
						whole blood and to transport this blood to the blood bank for processing, storing
						and distribution.
(d) Mobile unit is a
						transportable auxiliary to a blood bank designed, equipped, and staffed to procure
						human whole blood and to transport this blood to the blood bank for processing,
						storing and distribution.
(e) Whole
						blood is the fluid component of the human cardiovascular system composed of liquid
						and cellular elements.
(f) Plasma is the
						extracellular portion of anticoagulated whole blood.
(g) Blood derivatives or fractionation products
						are the individual elements of whole blood which have been processed or manufactured
						into their individual component parts, in accordance with procedures contained in
						Articles 10 and 11.
(h) Donor means the
						individual from whom blood is procured.
(i) All references to temperature are expressed in
						degrees centigrade.
1. Repealer
						  and new Article 10 (Sections
						  997 through
						  1003) filed 10-25-66; effective
						  thirtieth day thereafter (Register 66, No. 37). For history of former Article 10,
						  see Registers 56, No. 2, 59, No. 17, 60, No. 19 and 63, No. 17.
2.
						  Amendment of subsection (b) filed 10-25-72; effective thirtieth day thereafter
						  (Register 72, No. 44).
3. Renumbering of Article 10 to Article 9 and
						  amendment filed 3-5-76; effective thirtieth day thereafter (Register 76, No. 10).
						  For history of former Article 9 (Section
						  992) see Register 71, No.
						  34.
4. Change without regulatory effect repealing subsections (i)-(k),
						  relettering subsections, and amending NOTE filed 7-13-98 pursuant to section
						  100, title 1, California Code of
						  Regulations (Register 98, No. 29).
Note: Authority cited: Sections
							 1602.5,
							 1603,
							 100110
							 and
							 100275,
							 Health and Safety Code. Reference: Sections
							 1600-
							 1620,
							 Health and Safety Code.