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State
California Regulations
TITLE 17. PUBLIC HEALTH DIVISION 1. STATE DEPARTMENT OF HEALTH SERVICES

database is current through 09/29/06, Register 2006, No. 39






Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Chapter 1252, Statutes of 1977.


s 100. Eligibility Requirements.
(a) Hospital districts may apply for State loans to pay for medical injury tort claims or judgments that are in excess of $300,000. Such hospital districts shall meet all of the following:
(1) Be the Chowchilla Memorial Hospital District, or a hospital district which has entered into a joint powers agreement with the Chowchilla Memorial Hospital District.
(2) Be located in a county that has areas that are designated as rural medically undeserved areas by the Health Manpower Policy Commission, pursuant to Section 1188.4, Chapter 4, Part 4, Health and Safety Code (Rural Health Services, October 1976).
(3) Have a licensed bed capacity of less than 100 beds.
(4) Have submitted to the Department on or before September 8, 1977, a statement which includes the following:
(A) A utilization review plan or its equivalent which has been officially adopted by the governing body of the hospital districts and which:
1. Provides for the participation of the entire medical staff in a review committee.
2. Provides that at least one committee member is a nonphysician health professional.
3. Prohibits the participation on the committee of any person who has a financial interest in the hospital.
4. Prohibits any person from participation in the review of any care in which that person has been professionally involved.
5. Provides for at least monthly meetings of the review committee.
6. Provides for the retention for at least seven years of records of the review committee's activities, including the number and types of cases received, the findings and recommendations, and the subsequent actions taken.
(B) Proof of either insurance against medical injury liability claims or judgments up to $300,000 or the establishment of a reserve account in that amount, along with a plan for the investment of such reserves.
(C) A written plan for the preliminary investigation of medical injury claims and for procurement of legal counsel when indicated.
(D) A written plan to repay the State loan within forty (40) years detailing the resources available to the hospital district including taxing powers.


Note: Authority cited: Sections 32351-32355 and 32358, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23.


s 101. Loan Application.
(a) The hospital district shall make application for a State loan to the Director of Health Services, 714 P Street, Sacramento, CA 95814.
(b) Within ninety (90) days after the receipt of the application the Department of Health Services will notify the applicant of its preliminary finding and recommendation. The notice will contain the information that the Department's final recommendation to the Legislature must be made within the next thirty (30) days and that any information that the applicant has that will affect the preliminary recommendation should be forwarded immediately.


Note: Authority cited: Sections 32351-32355 and 32358, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23.

s 102. Coverage.
(a) The Department shall grant all loans which qualify, to the extent that funds are available, provided that:
(1) Such amount represents an excess of $300,000 in a medical injury tort judgment or settlement, the $300,000 being covered by insurance or reserve account, as specified in Section 100(a)(4)(B).
(2) The total amount of such loans does not exceed $1,000,000 in the aggregate.
(b) Physicians in the local community who are employees of the hospital district shall be covered for medical injury tort liability by the district.


Note: Authority cited: Sections 32351-32355, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355, Health and Safety Code, Division 23.

s 103. Repayment of Loans.
(a) Repayment of loans shall be on an amortized schedule agreed upon by the Department and the hospital district. The repayment period shall not exceed forty (40) years. The interest rate shall not exceed the five-year average on the return on the investment of State funds pursuant to Chapter 3 (commencing with Section 16430), Part 2, Division 4, Title 2 of the Government Code.
(b) In event of default of repayment of a loan, the Department may attach real property and assets of the hospital district to recover the amount of the loan and appropriate interest as specified in (a) above.


Note: Authority cited: Sections 32351-32355, Health and Safety Code, Division 23. Reference: Sections 32351, 32353, 32355 and 32358, Health and Safety Code, Division 23.







Revision (except Group 1) filed 3-30-51

Revision of Group 2 filed 1-19-54 and 6-13-75


Revision of Group 1 filed 7-15-57


Note: Authority cited: Sections 1231 and 1411, Health and Safety Code.





Note: Authority cited: Sections 102, 208 and 1411, Health and Safety Code. Reference: Sections 1400-1433, Div. 2, Ch. 2, Health and Safety Code.





Note: Authority cited: Sections 102, 208 and 1411, Health and Safety Code. Reference: Sections 1400-1433, Div. 2, Ch. 2, Health and Safety Code;









Note: Authority cited: Sections 11501, 11502, and 11503 of Insurance Code.





Note: Authority cited for Sections 860.0-875.0: Section 1509, Health and Safety Code.





Note: Authority cited for Sections 880 and 881: Section 212, Health and Safety Code.










s 901. Access to the Records in the Office of the State Registrar and in the Offices of Local Registrars.
Records of birth, death, and marriage in the Office of the State Registrar and in offices of local registrars for which access is not specifically prohibited by statute shall be open for examination by the public during regularly scheduled office hours subject to the restrictions listed in Health and Safety Code Sections 10125.5 and 10129.
The principal researcher who needs access to confidential information shall submit a signed agreement to the State Registrar with a copy to the local registrar when appropriate, assuring that any report shall not identify an individual and that working papers which may permit such identification shall be destroyed as set forth in the agreement. Any breach of the signed agreement shall result in denial of further access to the data.
No person, except as authorized by law, shall copy or retain copies of confidential data unless procedures in this section are followed.


Note: Authority cited: Section 6253, Government Code; and Sections 10001 and 10001.1(b), Health and Safety Code. Reference: Sections 10066 and 10125.5, Health and Safety Code.


s 902. Conditions of Examination.
(a) Authorization to examine the index or records in the Office of the State Registrar and in offices of the local registrars must be obtained from the registrar or deputy in charge.
Written application shall be made by the applicant stating sufficient information to identify the record or records to be examined.
The following information for the type of record specified below should, whenever possible, be provided by the applicant:
(1) Birth
(A) Name of child;
(B) Maiden name of mother;
(C) Date or year of birth.
(2) Death
(A) Name of decedent;
(B) Date or year of death, or date last known alive;
(C) Date or year of birth.
(3) Marriage
(A) Name of Groom or Maiden name of Bride;
(B) Date or year of marriage.
Where the above information is not available, the applicant shall provide whatever information is available, and the State Registrar or local registrar shall make all reasonable effort to locate the requested records.
(b) The State Registrar or local registrar shall supervise the examination of the records.


Note: Authority cited: Section 6253, Government Code; and Sections 10001 and 10001.1, Health and Safety Code. Reference: Section 10066, Health and Safety Code.


s 903. Fee for Examination or Search.


Note: Authority cited: Sections 10001 and 10001.1(b), Health and Safety Code. Reference: Section 10066, Health and Safety Code.


s 908. Late Registration of Births and Deaths.
The local registrar and the State Registrar of Vital Statistics shall accept for registration only those records of birth and death which are received by the local registrar within one year of the date of occurrence of the event, except as provided under Division 9, Chapters 9 and 10 of the Health and Safety Code.


Note: Authority cited: Section 10001, Health and Safety Code. Reference: Section 10577, Health and Safety Code.


s 910. Responsibilities of Local Registrar or County Recorder.
(a) Upon notification by the State Registrar that a person whose birth is registered in the local office is deceased, the local registrar or county recorder of such office shall make at least one of the following:
(1) A notation of the death in the birth index.
(2) A notation of the date of death and the death certificate number upon the record of birth.
(b) The local registrar or county recorder shall notify the State Registrar of any application for a certified copy of a deceased person's birth certificate in which it is indicated that the requested birth record is the applicant's own birth record.
(c) A birth card form shall not be issued where the birth record indicates the registrant is deceased.


Note: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038, and 10575.5, Health and Safety Code.


s 911. Identification of Deceased Registrants by Local Registrars and County Recorders.
Local registrars and county recorders may match deaths occurring in their jurisdictions to births registered in their office and, for any registrants thereby identified as deceased, make any of the notations specified in Section 910(a) (1) and (2).


Note: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038 and 10575.5, Health and Safety Code.


s 912. Certified Copies of Birth Certificates of Deceased Persons.
(a) All certified copies of birth records for which the registrant is identified as deceased shall display the legend "DECEASED," which shall be in boldface style not less than one-half inch in height, near the space reserved for the registrant's name.
(1) Unless produced by a photographic process or through the medium of an overlay employed in the copying process, the legend "DECEASED" shall be printed or stamped in indelible ink.
(2) The local registrar or county recorder shall obtain prior approval by the State Registrar of the method to be employed in producing the legend "DECEASED."


Note: Authority cited: Sections 10001 and 10575.5, Health and Safety Code. Reference: Sections 10038 and 10575.5, Health and Safety Code.


s 915. Live Birth.
"Live birth" means the complete expulsion or extraction from its mother of a product of conception (irrespective of the duration of pregnancy) which, after such separation, breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached.


Note: Authority cited: Section 10001, Health and Safety Code. Reference: Sections 10100 and 10102, Health and Safety Code.


s 916. Fetal Death.
"Fetal death" means a death prior to the complete expulsion or extraction from its mother of a product of conception (irrespective of the duration of pregnancy); the death is indicated by the fact that after such separation, the fetus does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles. Registration of fetal deaths is subject to the provisions of Division 9, Chapter 4 of the Health and Safety Code.


Note: Authority cited: Section 10001, Health and Safety Code. Reference: Section 10175, Health and Safety Code.





Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Sections 1725, 1726, 1727, 1728, 1728.1, 1729, 1731, 1734, 1735, 1736, 1737, 1737.5, 3123 and 3124, Health and Safety Code.









s 950. General Provisions.
(a) As used in this chapter "person" includes firm, association and corporation.
(b) As used in this chapter "department" means State Department of Health.


Note: Authority cited for Group 1 (ss 950 to 1021, inclusive): Sections 208, 1600, 1603, 1604, 1605, and 1606, Health and Safety Code. Issuing agency: State Department of Public Health.


s 951. Issuance of License.
(a) All persons desiring to produce process or distribute biologics shall make application to the department on a form provided by the department, and shall supply such other information as may be required by the department for the intelligent appraisal of the status of the laboratory, the product to be licensed, and the personnel with respect to the intent and purpose of the law.
(b) Licenses shall not be issued to any person not at the time fully prepared, equipped and actually processing (though not distributing), but the department will provide anyone contemplating the establishment of a processing laboratory with full information concerning the requirements and conditions for the preparation of the products that it is proposed to manufacture or distribute.
(c) A license shall not be issued unless and until the establishment is prepared to operate under the direct supervision of a competent person trained in bacteriological technic and in the preparation of biologics as defined in Section 1601, Health and Safety Code, whose qualifications have been approved by the department.
(d) A license shall not be issued unless the condition of the establishment and methods of preparation are such as to reasonably insure that the biologics produced will not be contaminated, dangerous, or harmful.
(e) A license shall not be issued for the preparation of any biologic as defined in Section 1601, Health and Safety Code, if advertised so as to mislead or deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, or shipped, bears or contains any statement, design, or device which is false or misleading in any particular.
(f) A license shall not be issued for a biologic product that has been specifically forbidden or disapproved by the United States Department of Health, Education and Welfare excepting products that may be specifically approved by the department, for experimental purposes but not for general sale and distribution.
(g) A license shall not be issued for the processing or distributing of any product without satisfactory scientific evidence of therapeutic or prophylactic value.


s 952. Application for Renewal of License.
Each licensee applying for renewal of license shall be subject to such review of his activities during the previous licensing period, and to such inspections of his premises, equipment and biologics produced by him as may be determined by the department for consideration in passing upon the application for renewal. Similarly, such licensee shall submit such data, records, and samples of products as may be designated by the department.


s 953. License Fees.
The fees for license application and for annual license renewal are six hundred dollars ($600).


Note: Authority cited: Sections 102, 208, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code.


s 956. Autogenous Vaccines.
Laboratories whose principal activity is general clinical work and whose only biologic product is autogenous bacterial vaccines do not require a license for the preparation of autogenous vaccines unless the making of autogenous vaccines constitutes 10 percent or more of the activity or source of income of the laboratory.


s 962. Inspection by Department.
(a) Each licensee or applicant shall permit any duly authorized employee of the department to enter his establishment at any reasonable hour, and shall permit said representative of the department to inspect without previous notification the entire premises of such establishment, including all buildings, compartments, and other places, and all equipment, such as chemicals, instruments, apparatus, and the like, as well as the methods used in the manufacture of, and all records maintained relative to biologics as defined in Section 1601, Health and Safety Code.
(b) Each licensee or applicant shall provide to the department such stock cultures or other materials from which biologics are produced and such completed products as may be required by the department for testing of identity, purity, potency or other analysis.


s 963. Records.
The licensee shall keep records of the source of the preparation, of tests for purity and potency, and of the methods of preparation of each batch of biologics as defined in Section 1601, Health and Safety Code, and the sale, shipment or other disposition of the same. The licensee shall supply to the department monthly, on forms provided by the department, such information from said records as the department may require, the licensee retaining a full and complete copy thereof in his files.


s 967. Storage.
Each licensee shall maintain a refrigerator of sufficient capacity to store all of those products in his possession which require refrigeration and the entire stock of such products shall be kept within the refrigerator at all times. The temperature of the refrigerator shall not be permitted to rise above 10 degrees C. or fall below 1 degree C., as indicated by a required standard mercury thermometer, except that storage below 1 degree C. is allowed if not specifically damaging to the product. Licensee shall not sell or distribute for resale or redistribution biologics which require refrigeration unless the purchaser or distributor for resale or redistribution is equipped to store said biologics in the manner above provided.


s 972. Containers and Labeling.
(a) No biological product either for human or animal use shall be distributed except in the original final container bearing the original label of the manufacturer; provided, however, that a licensed laboratory may purchase products from other producers likewise licensed by the State, and repack and relabel such products in smaller containers; provided, there are no changes, substitutions or additions in the product or the label, and further provided, that all such repacked biological products shall bear on the label the name of the manufacturer as well as the name of the distributor together with a statement that the product has been repacked. All such repacked products are subject to the requirements of Sections 1600 to 1621, inclusive, Health and Safety Code, and are not exempted from inspection and license by the department.
(b) The labels of all biologic products on the containers for general distribution shall show the name of the product, the lot number that will identify the lot or batch in the record of the manufacturer, the expiration date, and the name of the manufacturer. The expiration date shall be based on a period of duration approved by the department.
(c) The labels on all bottles and individual packages of bacterial vaccines (bacterins) shall give the correct name of the organism concerned and mixed bacterins shall give the names of each organism according to the classification of Bergey in the mixture and the proportion that each organism represents in the mixture. The concentration may be expressed in number per mil or in terms of a turbidity standard acceptable to the department.
(d) The labels on products requiring refrigeration or maintenance of uniform temperatures to avoid deterioration, shall specify the temperature range within which the product shall be maintained.
(e) To prevent accidental use, all stocks of labels and advertising not accepted by the department shall be destroyed.


s 977. Advertising.
(a) No statements regarding preventive or therapeutic value shall be made either on labels or circulars or in any form of advertising that are not in accord with the opinion held by the recognized authorities of the medical profession and no descriptive matter or discussion of mode of action of the product or theory of its applicability may be used that is not acceptable to the same authorities.
(b) No mention of the department shall be made in advertising either directly or indirectly.
(c) All advertising matter, statements, and representations pertaining to biologics licensed under Sections 1600 to 1620, Health and Safety Code, shall be submitted to the department at least 30 days prior to their use by the licensee.


s 982. Potency.
Licensees producing, processing or distributing biologics for which a potency test is recognized or prescribed by the United States Department of Health, Education, and Welfare, shall upon the request of the department, provide a representative sample of each lot of such product for purposes of checking. The particular lot so sampled shall not be distributed until approval is given by the department.


s 987. Vaccine Culture.
No culture shall be used in the preparation of live culture vaccine unless it is nonvirulent or has sufficiently low virulence as not to be reasonably likely to produce the disease in the inoculated person, or be dangerous from the standpoint of contagion. Such cultures must be tested and approved by the department before use.
The following conditions must be met and observed in the procurement, processing, storage, and distribution of whole blood (human) or blood derivatives for transfusion purposes:







The following conditions must be met and observed in the procurement,
processing, storage, and distribution of whole blood (human) or blood
derivatives for transfusion purpose.

s 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.


Note: Authority cited: Sections 1602.5, 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code.


s 998. Personnel of Blood Banks and Their Auxiliaries.
(a) Physicians and surgeons, clinical laboratory bioanalysts, clinical laboratory technologists, clinical laboratory technologist trainees and nurses who comprise the staff of the blood bank shall be duly licensed by or registered in the State of California. The staff may include such other persons, when approved by the director, as may be necessary for the proper operation of the blood bank, including volunteer workers.
(b) Director of Blood Bank. The blood bank and its auxiliaries shall be under the direction of a physician and surgeon duly licensed by the State of California, and who shall have a minimum of six months experience in blood bank methods, transfusion principles, and transfusion practices, satisfactory to the department. Attending Physician refers to the duly licensed physician and surgeon supervising blood collection activities.
(c) Laboratory Personnel. The laboratory personnel shall be licensed pursuant to the Clinical Laboratory Laws (California Business and Professions Code, Division 2, Chapter 3), except that unlicensed persons may be used to assist licensed personnel under their supervision, so long as such unlicensed persons do not perform laboratory tests or render judgment on such tests.


Note: Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603(c), Health and Safety Code.


s 999. Blood Bank Equipment, Facilities and Manual.


Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.


s 1000. Blood Bank Records; Identification of Human Blood with Its Donor.
(a) A system which carries through from donor to recipient must be used to identify the blood. This shall be accomplished by having blood container and pilot tube labels identified with the donor before venesection. The labels and personal history shall carry the same identification number. These labels shall accompany the donor to the collection room and shall be applied to the blood container and pilot tubes while it is still possible to check accurately the identity of the blood with the donor and his history. Other documents related to the blood such as invoices, if used, shall also contain the same identification number.
(b) Every California licensed blood bank shall obtain reports of reactions in individuals receiving its blood, or blood derivatives, where it appears that these materials from the blood bank may be implicated in such reactions. Reporting shall include also any illness whose cause may be related to transfusion of blood or blood derivatives provided by the blood bank. Forms for these purposes may be devised by the blood bank as a reminder to the transfusion services and as encouragement to them to comply with this requirement.
(c) In addition to the applicable portions of the regulations set forth in Section 963 and the first two paragraphs of this section, the blood bank shall keep complete records of each donor, which shall include all information specified in Section 1002. Records are required also which contain information related to the disposition of all blood collected or distributed.
(d) These records shall be kept for an interval of not less than five years after the expiration date of the blood unit involved. All such records shall be correlated in such a way that checking the complete history of each blood unit may be quickly and conveniently performed.
(e) Records of refrigerator temperatures shall fulfill the requirements contained in Section 1002(g)(2) of these regulations.
(f) All blood bank records shall be dated.


Note: Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603, Health and Safety Code.


s 1001. Labels.


Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.


s 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.


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


s 1002.1. Use of AIDS Antibody (HTLV-III) Test by Blood Banks.


Note: Authority cited: Sections 208 and 1603, Health and Safety Code. Reference: Section 1603, Health and Safety Code.


s 1003. Exceptions for Emergency Purposes.
In the event that an emergency occurs as defined in Chapter 7 (California Emergency Services Act), Division 1, Title 2 of the Government Code deviation from the provisions of Section 1001 and subsections (a) through (h) of Section 1002 of this Article will be permissible. The extent of deviation shall be determined by the blood bank director with concurrence by the department and shall be commensurate with the degree of emergency.


s 1004. Reporting Requirements.
(a) Notification of Positive Laboratory Finding for Syphilis. To assist the local health officer in the discharge of his duties under Section 3110 and 3194 of the Health and Safety Code, any person who is in charge of a blood bank in which a laboratory examination of any specimen derived from a donor yields serological or other evidence of syphilis shall promptly notify the health officer of the local health jurisdiction of the address of the donor. This notification shall contain the type of specimen, the date it was obtained, the nature and result of the test performed, and the name, address, and the date of birth of the donor who provided the specimen.
The notification may be made by mailing or otherwise delivering a legible copy of the laboratory report containing all of the required information or by a telephone communication which is documented in the blood bank's records.
(b) The notifications required in this section are confidential and not open for public inspection.


Note: Authority cited: Sections 1603, 1603.1(g), 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code.







The following must be met and observed for the procurement, processing, storage
and transportation of human blood for plasma:

s 1010. Procurement of Blood for Plasma Processing.


Note: Authority cited: Sections 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code.


s 1011. Personnel and Equipment.
Blood shall be processed into plasma only in blood banks adequately staffed and equipped for that purpose. The individual directly in charge of plasma processing shall be a physician and surgeon duly licensed by the State of California or an individual sufficiently trained in laboratory procedures relating to blood banking and plasma processing and whose qualifications have been approved by the department. The staff may include other trained persons necessary for the proper operation of plasma processing.


s 1012. Single Donor Plasma and Single Donor Fresh Frozen Plasma (Antihemophilic).


Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.


s 1013. Storage.


Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.


s 1014. Expiration Date.


Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.


s 1015. Other Tests.


s 1016. Filling the Final Container.


s 1017. Labeling.


s 1018. Diluent for Dried Plasma.


s 1021. Requirements for Release.


s 1024. Red Blood Cells (Human).


Note: Authority cited: Sections 1603, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1620, Health and Safety Code.


s 1024.1. Frozen Red Blood Cells.


Note: Authority cited: Sections 1602.5, 100110 and 100275, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety Code.


s 1025. Plasmapheresis.
(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.


Note: Authority cited: Sections 1602.5 and 100275, Health and Safety Code. Reference: Section 1602.5, Health and Safety Code.


s 1026. Other Blood Fractions; Procedures; Standards; Consultative Service.
Since procedures and standards for the preparation of other blood fractions, such as immune serum globulin, albumin, etc., for transfusion purposes are not as yet well suited for blood bank production, any biologies producer operating under the license of the department shall submit a complete protocol of procedures to be followed and shall be subject to the current specifications of the department regarding such products. This shall include specific licensure for the production of such materials, inspection, and the maintenance of appropriate standards. Such standards as are necessary will, in general, follow the usual blood banking procures with deviations general, follow the usual blood banking procedures with deviations only for specific reason. Such deviations and specific procedures shall be outlined in writing to the department by the biologics producer. Potential producers of such biologics should avail themselves of the consultative services of this department in order to provide for a proper production procedure consistent with regulations of the department, thus avoiding the installation of methods which must later be amended or changed.


s 1027. Definitions and Procedures to Be Followed.
(a) For the purpose of this article "person" includes laboratory, firm, association, corporation, co-partnership, and educational institutions, and "department" means State Department of Health.
(b) Etiologic Agents.
(1) For the purpose of this article microorganisms which may produce disease in man shall be referred to as etiologic agents.
(2) The provisions of this article do not apply to specimens transmitted to a laboratory operated by the State Department of Health or equivalent containers are used, or those of other public health department laboratories operating under certificates issued by the department.
(3) The provisions of this article do not apply to biological products licensed by the department or by the United States Department of Health, Education and Welfare.
(c) The following safety measures shall be used by persons initiating the transportation of etiologic agents.
(1) Containers shall be used which are constructed in a manner equivalent to those referred to in (b)(2) of this section.
(2) In the case of frozen materials the etiologic agent shall be packed in sufficient dry ice and insulation material to insure that the material will remain frozen for at least 24 hours longer than the expected time in transportation.
(3) The proposed recipient shall be notified when transportation of the etiologic agent begins. This shall include type of transportation and probable time of arrival at a designated place.
(4) The approved type of container, referred to in (b)(2) above, shall be labeled in such a way that the etiologic agent which it contains is clearly indicated in bold type. The label shall state clearly that material of an infectious nature is present within the container.
(5) The label shall state that if breakage or leakage occurs whoever first has knowledge of the accident will immediately notify the department and the local health officer having jurisdiction at the site of the accident. This report should also contain the names and addresses of those who may have been exposed to the etiologic agent as a result of the accident. If loss occurs the person first aware of this occurrence shall notify the department promptly and shall supply such additional details as may be available.


Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1603.5, Health and Safety Code.


s 1028. Waiver of Regulations.
Notwithstanding the other provisions of Group 1, Subchapter 1, Chapter 2 of Part I (commencing with Section 950) of Title 17 relating to the production and distribution of biologics, the Director may at his discretion waive such regulations for research projects approved by the Director. The waiver shall be for a specific period of time and subject to all conditions which the Director finds necessary to protect the public health.


Note: Authority cited: Section 102 and 208, Health and Safety Code. Reference: Sections 1600-1616, Health and Safety code.


s 1029. General Definitions.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1244, 1265, 1281, 1282, 1285, 1288.5 and 1300, Business and Professions Code.


s 1029.5. Accreditation Body.
"Accreditation body" means an approved accreditation organization for laboratories, as defined in 42 Code of Federal Regulations, Section 493.2.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 1288.5, Business and Professions Code.


s 1029.6. Accredited Institution.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1223, 1265, 1281 and 1288.5, Business and Professions Code.


s 1029.7. Accredited College or University.
"Accredited college or university" means an educational facility which has met the standards of the United States of America Accrediting Commission for Senior Colleges and Universities or the Accrediting Commission for Community and Junior Colleges; or, if a non-United States college or university, one that is evaluated and found equivalent by the American Association of Collegiate Registrars and Admissions Officers.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1260, 1261, 1261.5, 1263 and 1264, Business and Professions Code.


s 1029.9. Accredited Institution.
"Accredited institution" has the same meaning as given in Title 42 of the Code of Federal Regulations, Section 493.2.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.


s 1029.10. Accusation.
"Accusation" means a written statement filed in order to initiate a hearing to determine whether a right, authority, license, or privilege should be revoked, suspended, limited or conditioned, and which:
(a) Sets forth in ordinary and concise language the acts or omissions with which a person, entity, or laboratory and its owners or directors are charged with committing to the end that the person, entity or laboratory and its owners or directors will be able to prepare a defense; and
(b) Specifies the statutes and regulations alleged to have been violated.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1265, 1267, 1320, 1322 and 1326, Business and Professions Code; Section 11503, Government Code; and Section 14123, Welfare and Institutions Code.


s 1029.11. Antigen.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.


s 1029.13. Approved Public Health Laboratory.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241 and 1288.5, Business and Professions Code.


s 1029.15. Alternative Sanction.
"Alternative sanction" means one or more of the following sanctions:
(a) Directed plan of correction;
(b) Civil money penalty; or
(c) Onsite monitoring.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c.510, Section 1; and Section 1310, Business and Professions Code.


s 1029.17. CLIA Certificate.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1224, 1265, 1281 and 1288.5, Business and Professions Code.


s 1029.19. CLIA Exempt Status.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Stats. 1995, c. 510 (SB 113) Section 1(a)(6).


s 1029.20. Antibody.
"Antibody" means an immunoglobulin molecule that, due to its specific amino acid sequence, reacts to the antigen that induced its synthesis in the cells of the lymphoid series.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.


s 1029.23. Direct Patient Care.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1206.5, Business and Professions Code.


s 1029.25. Antigen.
"Antigen" means any viral component including, but not limited to, proteins and nucleic acids.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 120775, Health and Safety Code.


s 1029.27. HHS.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5 and 1224, Business and Professions Code.


s 1029.30. Approved Public Health Laboratory.
"Approved public health laboratory" means a laboratory that has been issued a certificate of approval by the department after its determination that the public health laboratory, as defined in Business and Professions Code section 1206(a)(11), is in conformity with chapter 7 (commencing with section 1000) of part 2 of division 1 of the Health and Safety Code and the regulations adopted thereunder. (continued)