Home Table of Contents

§ 1025. Plasmapheresis.

17 CA ADC § 1025Barclays Official California Code of Regulations

Barclays California Code of Regulations
Title 17. Public Health
Division 1. State Department of Health Services (Refs & Annos)
Chapter 2. Laboratories (Refs & Annos)
Subchapter 1. Service Laboratories
Group 1. Production and Distribution of Biologics
Article 11. Preparation of Other Blood Derivatives
17 CCR § 1025
§ 1025. Plasmapheresis.
Currentness
(a) Requirements:
(1) No more than 500 milliliters of whole blood shall be removed from a donor at one time, unless the donor's weight is 175 pounds or greater in which case no more than 600 milliliters of whole blood shall be removed from the donor at one time.
(2) A duly licensed physician and surgeon shall be available as described in Section 1002(a) when plasmapheresis is performed.
(3) A system shall be employed which gives maximum assurance against any possibility of return of the separated red cells to an individual other than their donor.
(b) Examination and Laboratory Tests. Examinations and laboratory tests to assist in determining the donor's health shall include the following:
(1) Within no more than one week prior to the initial plasmapheresis, the donor shall be examined and certified to be in good health by a duly licensed physician and surgeon, as indicated in the applicable sections of the regulations. All donors shall have a physical examination by a duly licensed physician and surgeon at least once a year.
(2) A whole blood hemoglobin or hemoglobin or hematocrit concentration shall be performed prior to each plasmapheresis procedure.
(3) Determination of total protein shall be done at the time of each plasmapheresis procedure. the total protein shall not be less than 6.0 grams per 100 ml of plasma.
(4) The ratios of the various protein components of the donor's serum shall be determined from a sample taken at the time of his initial plasmapheresis and at intervals of not more than four months thereafter so long as he remains on a plasmapheresis program.
(5) To qualify for further plasmapheresis, all of the values determined under this section must be within the acceptable normal range.
(c) Samples for Laboratory Tests. Samples for laboratory tests shall not exceed 30 ml of whole blood in a seven-day period.

Credits

Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.
History
1. Amendment filed 11-24-69; effective thirtieth day thereafter (Register 69, No. 48).
2. Amendment filed 3-5-76; effective thirtieth day thereafter (register 76, No. 10).
3. Change without regulatory effect repealing subsections (a)-(b)(2)(B), (c)(1)-(c)(3) and (e)-(e)(1), relettering subsections, amending newly designated subsections (a)(2) and (b)(2) and adopting new Note filed 7-13-98 pursuant to section 100, title 1, California Code of Regulations (Register 98, No. 29).
This database is current through 4/26/24 Register 2024, No. 17.
Cal. Admin. Code tit. 17, § 1025, 17 CA ADC § 1025
End of Document