Cal. Code Regs. tit. 17 § 1002

Current through Register 2023 Notice Reg. No. 44, November 3, 2023
Section 1002 - Requirements - Donors, Medical History, Blood Collection, Storage and Testing
(a) Responsibilities. Final responsibility for the acceptance of donors rests with the attending physician.

Any time blood is collected under license, adequate medical care for the donor shall be provided. Blood shall be drawn from the donor under the supervision of a physician or registered nurse trained in the procedure. Blood may be collected when a physician is not present on the premises under the following conditions:

(1) The medical director and his medical advisory committee, if he has one, must approve.
(2) The employee placed in charge, in the absence of a qualified physician must be a registered nurse.
(3) The nursing staff and medical director must have a mutually clear understanding of the criteria for donor selection. Consultation with the medical director by telephone from mobile unit operations about certain donors may be necessary.
(4) A qualified physician or emergency medical facility shall be available nearby. Having a physician or emergency medical facility available is for the purpose of attending to donors who have a severe reaction or accident related to the blood donation. "Available" means no longer than 15 minutes away.
(5) Written emergency standing orders for donor care must be prepared by the medical director and be made available to the nursing staff. Appropriate training and refresher courses in emergency resuscitative methods must be planned. The nursing staff must be given special training on the symptomatology and emergency treatment of such conditions as cardiac and vascular disease, syncope, fractures, etc.

The attending physician shall sign all donor records, except that he may delegate the responsibility for signature to an employee of the blood bank whose license permits him to perform functions related to medical practice when under medical supervision.

Irrespective of location, the blood bank under whose license the blood is to be processed shall be responsible for all personnel engaged in examining donors and collecting blood, as well as the space and equipment used.

(b) Collection of Blood. (Refer to Section 1000(a) for requirements relative to donor identification.)
(1) Protection of the Donor Against Infection and Injury.

The preparation of the skin at the sites of venipuncture and of injections incidental to venipuncture shall be adequate to protect the donor against infection.

Apparatus or instruments such as syringes, needles, and lancets or other blood-letting devices capable of transmitting infection from one donor to another shall be sterile single-use instruments insofar as possible.

All such instruments intended for reuse shall be heat sterilized prior to each use and protected against contamination. Heat sterilization shall be by autoclaving for 30 minutes at 121.5 C (15 lb. p.s.i. pressure), by dry heat for two hours at 170 C, or by boiling in water for 30 minutes. Times, temperatures and pressures in excess of those stated are permissible.

Such heat sterilization shall include the use of a heat indicator satisfactory to the department, which will serve as evidence of proper sterilization. The heat indicator used shall be retained for one year as a record relating to the sterilization in which it was used. The record of temperature attained shall be kept on file in the blood bank for five years. This record may be kept either as hand-written chart showing temperatures at different times, or as information from an automatic recorder.

Instruments used in puncturing the skin, if not prepared for reuse, shall be disposed of in such a way that they cannot be reused.

Thermometers shall be sufficiently cleansed before use to minimize the transmission of disease.

The staff concerned with blood collection shall be instructed in the first aid procedures to be used in the event of a reaction, and suitable drugs and supplies shall be immediately available for use. Donors shall be kept under continuous observation throughout the entire procedure of blood collection and for at least 15 minutes thereafter.

(c) Laboratory Tests.
(1) Serologic Tests for Syphilis. A serologic test for syphilis approved by the department shall be made on a sample of blood taken from the donor at the time of blood collection. Blood shall not be used for transfusion unless the result of this test is nonreactive (negative), except in emergency situation with the consent of the blood bank director and the patient's attending physician.

All California licensed blood banks must accept and test evaluation sera provided by the department or a proficiency testing service approved by the department, and report test results to the department. Any blood bank laboratory showing unsatisfactory performance shall make changes as recommended by the department.

(d) Issue of Blood. Issuance of blood shall be in compliance with the provisions of the Health and Safety Code, Division 2, Chapter 4, Sections 1600.3 and 1604.

The laboratory tests and other procedures with respect to the preparation of blood for transfusion after it has been delivered to a transfusion service by the blood bank shall be the sole responsibility of the transfusion service. (See Section 1605 of the Health and Safety Code.)

As a condition to supplying blood, the blood bank director may inquire into the pretransfusion procedures used by the transfusion service and he may suggest as a minimum those described in the latest edition of "Standards for Blood Banks and Transfusion Services," published by the American Association of Blood Banks. Blood banks shall not supply blood to transfusion services in which the department finds pretransfusion procedures which differ from these standards, or from such other standards which are essentially equivalent to these, as determined by the department.

Cal. Code Regs. Tit. 17, § 1002

Note: Authority cited: Sections 1602.5 and 1603, Health and Safety Code. Reference: Sections 1602.5 and 1603, Health and Safety Code.

1. Amendment of subsections (b) and (c) filed 5-25-77; effective thirtieth day thereafter (Register 77, No. 22). For prior history, see Register 76, No. 10.
2. Amendment of subsections (a)(3), (c)(6), (g)(1) and (i) filed 1-18-78; effective thirtieth day thereafter (Register 78, No. 3).
3. Amendment of subsection (b)(6) filed 2-6-79 as an emergency; effective upon filing (Register 79, No. 6).
4. Certificate of Compliance filed 5-18-79 (Register 79, No. 20).
5. Amendment of subsection (a)(3) filed 4-10-86; effective thirtieth day thereafter (Register 86, No. 15).
6. Amendment of subsection (a)(4) filed 10-2-87: operative 10-2-87 pursuant to Government Code Section 11346.2(d) (Register 87, No. 41).
7. Editorial correction of subsection (a)(2) (Register 87, No. 41).
8. Change without regulatory effect repealing subsections (a)-(c)(6), (e)(2)-(g)(5), (h)(2)-(i) and (k)-( l)(4), relettering subsections, amending newly designated subsection (b) and amending Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).