Cal. Code Regs. tit. 17 § 997

Current through Register 2024 Notice Reg. No. 16, April 19, 2024

Section 997 - Definitions

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.

Cal. Code Regs. Tit. 17, § 997

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.

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).