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(3) An applicant for admission to the examination for a clinical immunohematologist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in biology, clinical laboratory science or equivalent major which shall include at least 25 semester or 38 quarter units in biology, including genetics and immunology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in all areas of the specialty of immunohematology, as listed in (b)(3) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of immunohematology.
(4) An applicant for admission to the examination for clinical toxicologist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate or higher degree in chemistry or equivalent major which shall include at least 25 semester or 38 quarter units in chemistry including analytical chemistry or quantitative analysis. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by a college or university from an accredited college or university; and
(B) Have completed one year of post-baccalaureate training or experience in the specialty of toxicology, as specified in (b)(4) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the subspecialty of toxicology.
(5) An applicant for admission to the examination for a clinical hematologist scientist license shall meet both of the following requirements:
(A) Hold a baccalaureate degree from an accredited college or university in biology, clinical laboratory science or an equivalent major which shall include at least 25 semester or 38 quarter units in biology, including hematology. This coursework shall be verified by an official transcript showing college or university courses, training and degree posted by an accredited college or university; and
(B) Have one year of post-baccalaureate training or experience in all areas of the specialty of hematology, as specified in (b)(5) below, in a clinical laboratory that possesses a certificate issued under CLIA for performing high complexity testing in the specialty of hematology.
(b) Any license issued under this section shall specify the particular specialty or subspecialty in which the licentiate may perform tests under such license. A license issued for:
(1) A clinical chemist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of chemistry, including routine chemistry, clinical microscopy, endocrinology and toxicology; immunology, including diagnostic immunology and syphilis serology; and molecular biology.
(2) A clinical microbiologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA in the specialty or subspecialties of microbiology including bacteriology, mycobacteriology, mycology, parasitology, and virology; immunology, including diagnostic immunology and syphilis serology; and molecular biology.
(3) A clinical immunohematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of immunohematology including ABO/Rh Type or Group, unexpected antibody detection, compatibility testing and antibody identification.
(4) A clinical toxicologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the subspecialty of toxicology.
(5) A clinical hematologist scientist shall specify that the licentiate is authorized to perform clinical laboratory tests or examinations classified as high complexity under CLIA limited to the specialty of hematology including routine hematology and coagulation.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code.


s 1031.1. Licensure of Clinical Histocompatibility Scientists.
(a) Each person performing high complexity laboratory tests or examinations in the subspecialty of histocompatibility in a licensed clinical laboratory shall possess a valid clinical histocompatibility scientist license except for the following persons:
(1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of the Business and Professions Code; or
(2) A histocompatibility laboratory director licensed pursuant to chapter 3 of the Business and Professions Code; or
(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3 of the Business and Professions Code; or
(4) A clinical laboratory scientist licensed pursuant to chapter 3 of the Business and Professions Code.
(b) In order to be eligible for licensure as a clinical histocompatibility scientist an applicant shall have been certified as a Clinical Histocompatibility Technologist by the American Board of Histocompatibility and Immunogenetics, either:
(1) Prior to January 1, 1997 and have had at least 6 years' experience in all areas of clinical histocompatibility testing in a clinical laboratory, or
(2) After January 1, 1997 and have a baccalaureate degree in biological or clinical science and one year of clinical laboratory experience in all areas of clinical histocompatibility testing in a clinical laboratory.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1209.1, 1210 and 1261, Business and Professions Code.


s 1031.2. Licensure of Clinical Cytogeneticist Scientists.
(a) Each person performing high complexity tests or examinations in the specialty of cytogenetics in a licensed clinical laboratory shall possess a valid clinical cytogeneticist scientist license except for the following persons:
(1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of division 2 of the Business and Professions Code; or
(2) A clinical cytogeneticist licensed to direct a cytogenetics laboratory pursuant to chapter 3; or
(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or
(4) A clinical laboratory scientist licensed pursuant to chapter 3.
(b) In order to be eligible for licensure as a clinical cytogeneticist scientist, an applicant shall:
(1) Hold a baccalaureate or an equivalent or higher degree, which shall include at least 25 semester or 38 quarter hours in biology, chemistry or clinical laboratory science from an accredited college or university, and
(2) Provide evidence of satisfactory performance on a written examination in the specialty of cytogenetics administered by the National Credentialing Agency for Laboratory Personnel (NCA), and either:
(A) On or after March 14, 2003, have completed at least one year training and/or experience in clinical cytogenetics in a clinical laboratory certified by the Centers for Medicare and Medicaid Services (CMS) in clinical cytogenetics. This training shall be approved by the department pursuant to Section 1035 and acceptable for admission to an examination by the NCA in the specialty of cytogenetics; or
(B) Prior to March 14, 2003, have completed training and/or experience in clinical cytogenetics, which is acceptable for admission to an examination by the NCA in the specialty of cytogenetics, in a clinical laboratory certified by CMS in clinical cytogenetics or in histopathology (cytogenetics).


Note: Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business and Professions Code.


s 1031.3. Licensure of Clinical Genetic Molecular Biologist Scientists.
(a) Each person performing high complexity tests or examinations in the subspecialty of genetic molecular biology in a licensed clinical laboratory shall possess a valid clinical genetic molecular biologist license except for the following persons:
(1) A physician and surgeon licensed by the State to practice medicine pursuant to chapter 5 of division 2 of the Business and Professions Code; or
(2) A clinical genetic molecular biologist licensed to direct a genetics laboratory pursuant to chapter 3; or
(3) A clinical laboratory bioanalyst licensed pursuant to chapter 3; or
(4) A clinical laboratory scientist licensed pursuant to chapter 3.
(b) In order to be eligible for licensure as a clinical genetic molecular biologist scientist, an applicant shall hold a baccalaureate or an equivalent or higher degree in a biological or clinical laboratory science, or field related to genetics from an accredited college or university; and
(1) Have completed at least one year training and/or experience in clinical genetic molecular biology in a clinical laboratory certified by the Center for Medicare & Medicaid Services (CMS), performing high complexity testing in clinical genetic molecular biology. This training and/or experience shall be acceptable for admission to an examination by the National Credentialing Agency for Laboratory Personnel (NCA) in the specialty of molecular biology. On or after March 14, 2003, this training shall be approved by the department pursuant to Section 1035; and
(2) Provide evidence of satisfactory performance on a written examination in molecular biology administered by the NCA.


Note: Authority cited: Sections 1224, 1261 and 1261.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1205, 1206, 1206.5, 1210, 1222.5, 1261, 1261.5, 1262, 1282 and 1286, Business and Professions Code.


s 1031.4. Requirements and Timeframes for Applications for Licensure and Certification.
(a) Applications for admission to a state-administered licensing examination shall be complete when the information specified in Section 1031.4(b) has been received by the department. For an applicant to be eligible for a scheduled examination, the completed application must be postmarked at least 120 days prior to the examination date as published by the Department of Health Services. When applying for admission to the examination, the applicant shall state whether he or she has previously applied to the department for admission to an examination.
(b) An application for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations under Chapter 3 shall be considered complete when the following is provided to the department:
(1) Name and address of the applicant, including city, state and zip code; and
(2) Social security number of the applicant (Pursuant to the authority found in Section 1224 of the Business and Professions Code and in Section 100275 of the Health and Safety Code, and as required by Section 17520 of the Family Code, it is mandatory to provide the social security number. The social security number will be used for purposes of identification.); and
(3) Gender and birthdate; and
(4) License for which the applicant is applying; and
(5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and
(6) Documentation of the applicant's education including:
(A) Name, address, major course of study, dates of attendance, number of credits, and degree/completion date for all colleges and universities attended by the applicant; and
(B) Official transcripts from the registrar of all accredited colleges or universities attended by the applicant showing all courses, course credits, degrees conferred and date of conference; and
(C) Official transcripts from non-United States colleges or universities which are not in English shall be returned to the applicant to obtain translation from a translation service approved in the United States for legal or government documents.
(7) Documentation of the applicant's training including:
(A) Name and address of training program, dates of training, specialty and subspecialty areas of training, length of time in each specialty and subspecialty area of training; and
(B) Signed documentation from the training program director that this training has been successfully completed; and
(8) Documentation of the applicant's experience, appropriate to the specific license for which the applicant is applying, including the following:
(A) Facility name, address, dates of employment, number of hours per week employed, the specialties and subspecialties in which clinical laboratory tests or examinations were performed and a description of clinical laboratory tests or examinations performed; and
(B) Signed documentation of such experience from the director of the laboratory; and
(9) Evidence of satisfactory performance on a licensing examination pursuant to Section 1029.81; and
(10) Signature of the applicant, telephone number and date of application; and
(11) Payment of license application fee pursuant to Business and Professions Code Section 1300.
(c) An application for certification in phlebotomy shall be considered complete when the following is provided to the department:
(1) Name and address of the applicant, including city, state and zip code; and
(2) Social security number of the applicant (Pursuant to the authority found in Section 1224 of the Business and Professions Code and in Section 100275 of the Health and Safety Code, and as required by Section 17520 of the Family Code, it is mandatory to provide the social security number. The social security number will be used for purposes of identification.); and
(3) Gender and birthdate; and
(4) Category of phlebotomy certification for which the applicant is applying; and
(5) Whether the applicant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations; and
(6) Documentation of the applicant's education including:
(A) Name, address, dates of attendance, coursework completed and graduation as verified by official school transcripts; or
(B) Documentation of a passing score on the general educational development (GED) test or equivalent education as evaluated by the American Association of Collegiate Registrars and Admissions Officers for secondary education; or
(C) For official school transcripts which are not in English, documentation of equivalent education as obtained through translation into English from a translation service approved in the United States for legal or government documents; and
(7) Certification of the applicant's instruction in phlebotomy as specified in Section 1035.1(h); and
(8) Certification of the applicant's on-the-job experience in phlebotomy, if applicable, including:
(A) Name and address of laboratory where employed, dates of employment, number of hours of experience in techniques specified in Section 1035.1(f) and an estimate of the number of skin punctures, venipunctures or arterial punctures performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfills all the sampling requirements of all clinical laboratory tests or examinations; and
(B) Signed documentation from the director of the laboratory that the above information accurately represents the applicant's experience in phlebotomy; and
(9) Evidence of satisfactory performance on a certification examination in phlebotomy administered by a certifying organization that was approved by the department pursuant to Section 1031.7 at the time the examination was administered; and
(10) Signature of the applicant, telephone number and date of application; and
(11) Payment of a two-year certification fee of $50.
(d) Timeframes for processing applications for licensure to direct a clinical laboratory or to perform clinical laboratory tests or examinations or for certification to perform phlebotomy pursuant to Chapter 3 shall be as follows:
(1) The department shall notify the applicant in writing, within 90 days of receipt of an application, of one of the following:
(A) The application is complete and will be processed by the department; or
(B) The application is incomplete and not accepted for processing. The department's written notification shall include the specific information, documentation or fee in which the application is deficient; or
(C) The application has been reviewed and does not meet the requirements and that approval is denied. The department shall give written notification of the basis for the denial.
(2) The department shall notify the applicant within 90 days of postmark date of resubmission of application requirements pursuant to Section 1031.4(d)(1)(B) whether the application has been approved or denied.
(3) Written notification by the department to applicants shall be deemed to occur on the date of the postmark from the department.
(4) The department shall deem an application abandoned by an applicant who fails to respond or to supply all information, documents, verifications or payment of applicable fees within 30 days of notification by the department.
(5) The department's time periods for processing an application for licensure or certification from the date the application is complete to the date the final decision is made regarding an approval are as follows:
(A) The median time for processing an application is 90 days;
(B) The minimum time for processing an application is 30 days; and
(C) The maximum time for processing an application is 150 days.
(e) Certification shall be valid for a period of 2 years unless revoked.
(f) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.
(g) All applicants, licensees and certificants pursuant to Section 1031.4 shall notify the department in writing of any change(s) of name and /or address within 30 days after the change(s) has occurred.


Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Section 17520, Family Code. Reference: Sections 1203, 1204, 1205, 1207, 1209, 1209.1, 1210, 1220, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301, 1301.1 and 1320, Business and Professions Code; Section 120580, Health and Safety Code; and Section 15376, Government Code.


s 1031.5. Requirements and Timeframes for Renewal of Licenses and Certificates.
(a) In order to maintain a license in active status, licenses shall be renewed by filing a renewal application within 60 days prior to the end of the license period.
(b) A complete license renewal application shall include name and address of the licensee, license number, current work location(s), documentation of continuing education credits, an attestation stating whether the licensee has or has not been convicted of any felonies or misdemeanors other than minor traffic violations in the previous two years, license renewal fee, signature and date of application for renewal.
(c) In order to maintain a phlebotomy certificate in active status, certificates once approved shall be renewed at biennial intervals by filing a renewal application within 60 days prior to the end of the certificate period.
(d) A complete phlebotomy certificate renewal application shall include name and address of the certificant, certificate number, current work location(s), documentation of continuing education performed during the previous 24 months, an attestation stating whether the certificant has or has not been convicted of any felonies or misdemeanors other than minor traffic violations in the previous two years, certification renewal fee of $50, signature and date of application for renewal.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1203, 1204, 1205, 1207, 1209, 1209.1, 1210, 1226, 1241, 1242, 1242.5, 1246, 1260, 1261, 1261.5, 1263, 1264, 1282, 1300, 1301 and 1301.1, Business and Professions Code; and Section 120580, Health and Safety Code.


s 1031.7. Conditions for Approval of Certifying Organizations to Administer Phlebotomy Certification Examinations.
(a) In order for a certifying organization to be eligible for approval by the department to administer a phlebotomy certification examination for state certification purposes, the certifying organization shall meet the following conditions:
(1) The certifying organization shall be a national, independent, not-for-profit, professional certifying organization; and
(2) The certifying organization shall offer examinations in phlebotomy; and
(3) The certifying organization shall provide the following to the department:
(A) The organization's name and address; and
(B) Names of the organization's officers and board of directors; and
(C) A description of the organization's structure; and
(D) The identity of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and
(E) A schedule of dates and times that the examination will be conducted within the state; and
(F) Listing of procedures for monitoring the content, quality, validity and relevance of the phlebotomy examinations pursuant to Section 1031.7 (b); and
(G) The philosophy of the organization, demonstrating a commitment to accurate assessment of a candidate's preparation for phlebotomy certification.
(b) In order for a certifying organization's examination to be approved for certification purposes, the organization shall document the following standards to support a request for approval:
(1) Evaluation of relevant standards in phlebotomy and how the organization's examinations address knowledge and skills that would assure competence of the candidate; and
(2) Explanation of how the examinations are developed by the organization and the qualifications of person(s) who develop the examination questions; and
(3) Documentation that the organization's examinations are subject to annual review for current relevance; and
(4) Demonstration of the ability of the organization to evaluate its examinations, subjecting the examinations to validity and reliability assessments using psychometric performance standards, and the capability of the organization to provide this information at least once yearly or upon request to the department.
(c) An organization approved to administer a phlebotomy examination shall:
(1) Agree to make the content of its examinations available to the department for confidential review; and
(2) Demonstrate how it will maintain security during administration of the examination, ensure the identity of the examinee, and maintain the confidentiality of the examination; and
(3) Document how it will make its records accessible to the department regarding those persons participating in the examination and their scores; and
(4) Provide verification of those persons successfully passing the certification examination to the department and shall maintain these records for five years; and
(5) Issue a certificate to those passing the examination with the examinee's name, name of the certifying organization, type of certificate, effective date and official signature.
(d) Timeframes for processing applications for approval of a certifying organization's certification examination shall be as follows:
(1) Within 90 calendar days of receipt of an application, the department shall inform the organization in writing that the application is either complete and accepted for review or that it is deficient and what specific information or documentation is required to complete the application.
(2) Within 180 calendar days from the date of filing a completed application, the department shall inform the applicant certifying organization in writing whether the organization has been approved or denied as a certifying organization for the administration of the certification examination.
(3) The department shall deem an application abandoned by an applicant certifying organization that fails to respond or to supply all information, documents, or verifications within 30 days of notification pursuant to Section 1031.7(d)(1).
(4) The department's time periods for processing an application for approval as a certifying organization, from the receipt of the initial application to the final decision regarding the approval, are as follows:
(A) The median time for processing is 180 calendar days.
(B) The minimum time for processing is 90 calendar days.
(C) The maximum time for processing is 360 calendar days.
(e) Approval shall be valid for a period of four years unless revoked.
(f) To apply for renewal, a certifying organization shall file a renewal application at least 120 days prior to the end of the approval period providing the following:
(1) The name and address of the certifying organization; and
(2) Names of the organization's officers and board of directors; and
(3) Name of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and
(4) A schedule of dates and times that the examination will be conducted within the state for the next 12 months; and
(5) A copy of the current examination; and
(6) Signature of the program director and date of application for renewal.
(g) Failure to meet the requirements of this section shall be good cause for denial or revocation of approval by the department.
(h) A certifying organization shall notify the department in writing of any change(s) in the information and material required by Subsections (a) through (c) within 30 days after the change(s) has occurred.


Note: Authority cited: Sections 1224 and 1320, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1242, 1242.5, 1246 and 1269, Business and Professions Code; and Section 120580, Health and Safety Code.


s 1031.8. Conditions for Approval of a Certifying Organization to Administer a Certifying Examination for Licensure Purposes.
(a) In order for a certifying organization to be eligible for approval by the department to administer a category of certifying examination, the organization shall file a complete application that consists of the following:
(1) Documentation that the certifying organization is a national, independent, not-for-profit, professional certifying organization; and
(2) The organization's name and address; and
(3) Names of the organization's officer(s) and board of directors; and
(4) Description of the organization's structure and organizational chart; and
(5) The identity of the person designated by the organization to be responsible for overseeing the administration and coordination of examination activities; and
(6) A mission statement that demonstrates the philosophy of the certifying organization commits to an accurate assessment of a candidate's preparation in the clinical laboratory science category in which the candidate is examined; and
(7) Schedule of dates that the examination will be available to California licensure applicants during the next four years; and
(8) Listing of procedures for monitoring the content, quality, validity, reliability and relevance of the examination in the specialty being tested, and
(9) Demonstration of how the organization's examination addresses the relevant standards in the clinical laboratory science category being examined, and how it evaluates the knowledge and skills that would assure competence of the candidate; and
(10) Explanation of how the examination structure is developed by the organization, and the qualifications of person(s) who develop the examination questions; and
(11) Documentation that the organization's examination is subject to annual review for current relevance; and
(12) Demonstration of the ability of the organization to evaluate its examination, subjecting it to validity and reliability assessments using psychometric performance standards, and the capability of the organization to provide this information at least annually or upon request to the department; and
(13) Explanation of how the examination is developed and weighted using a job task survey to determine knowledge and skills required to be competent in the examination category; and
(14) Explanation of how examination questions are established, evaluated and updated to match current practice for the category; and
(15) Explanation of how the cutoff score for those successfully passing the examination is determined; and
(16) Documentation of performance statistics for the examination during the previous five years, including pass/fail rate, number of applicants and number accepted to the examination for each time that the examination has been administered by the certifying organization during the five years immediately prior to the date of application, or, for specialties that have been established for less than five years, during the period dating from the establishment of the specialty to the date of the application; and
(17) Submission of printed copies of examinations given each year for the previous four years, if the examinations were offered. These examination shall be subject to confidential review by the department, shall not be copied, and shall be returned to the organization; and
(18) Submission of an agreement to provide the examination to candidates who have been approved for admission to the examination by the department; and
(19) Submission of an agreement to provide verification of those persons successfully passing the examination to the department and to maintain these records for five years; and
(20) Submission of an agreement to give evidence of satisfactory performance as official notification to those passing the examination with the examinee's name, name of the certifying organization, examination category, effective date and official signature; and
(21) Demonstration how the organization will maintain security during development and administration of the examination, ensure the identity of the examinee, and maintain the confidentiality of the examination; and
(22) Listing of procedures in use and required of the organization's personnel to ensure security and confidentiality of the examination, and steps to be taken if a breach is discovered; and
(23) An agreement that a breach of security shall be reported to the department and that the department is authorized to investigate and withdraw approval of the examination category; and
(24) Documentation how the organization will make its records accessible to the department regarding those persons participating in the examination and their scores; and
(25) The name, title, and signature of the person who is responsible for overseeing the administration and coordination of all examination activities, and the date the application was signed.
(b) Initial approval of an organization's examination category shall include confidential review of an examination given each year up to four years immediately preceding the date of approval, so that examinations taken during this time shall be acceptable for licensure purposes.
(c) Timeframes for processing applications for approval of a certifying organization's examination in a clinical laboratory science category for licensure purposes shall be as follows:
(1) The department shall notify the applicant organization within 90 days of submission of an application of one of the following:
(A) That the application is complete and acceptable for processing by the department; or
(B) That the application is incomplete and not accepted for processing. This notification shall include the specific information or documentation that the applicant shall submit within 30 days in order for the department to consider the application acceptable; or
(C) That the application has been reviewed and does not meet the requirements of this section and that approval is denied.
(2) The department shall consider an application to have been abandoned by any applicant who fails to respond to the department's request to submit specific information or documentation within 30 days of notification pursuant to Section 1031.8(c)(1)(B).
(d) Written notification by the department to the applicant organization shall be considered to occur on the date the documents are postmarked,
(e) A certifying organization shall notify the department in writing of any change in the information and materials required by this section within 30 days after the change has occurred.
(f) Failure to meet and maintain the requirements of this section shall be good cause for denial or revocation of approval by the department.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 1262, 1263 and 1264, Business and Professions Code.


s 1031.9. Conditions for Renewal of a Certifying Organization's Approval to Administer Examinations Acceptable for Licensure Purposes.
(a) Approval of a certifying organization shall be valid for a period of four years unless revoked. At least 120 days prior to the end of the approval period, the certifying organization that wants to continue approval of its examination shall apply for reapproval. Failure to reapply 120 days in advance shall cause a lapse in approval after which time the examination would not be acceptable for licensure purposes until the certifying organization regains approval. A certifying organization that fails to reapply at least 120 days in advance and subsequently elects to seek approval shall make application pursuant to Section 1031.8.
(b) To apply for renewal of a certifying organization's approval to administer examinations, the organization shall provide the following:
(1) The name and address of the certifying organization; and
(2) Names of the organization's officer(s) and board of directors; and
(3) Name of the person designated by the organization to be responsible for overseeing the administration and coordination of all examination activities; and
(4) A schedule of dates that the examination will be available to California applicants during the next four years; and
(5) A summary of the performance statistics of the examination during the previous approval period, including the number of California applicants applying for, and successfully passing, the certifying examination, the applicant scores, what efforts have been made to evaluate the examination and update the examination questions to match current practice for the category; and
(6) The name, title and signature of the person responsible for overseeing the administration and coordination of all examination activities and date of application for renewal.
(c) The timeframes for processing an application of a certifying organization seeking renewal of its examination approval shall be as follows:
(1) The certifying organization shall submit an application for renewal of approval of its examination at least 120 days prior to the end of the approval period.
(2) Within 30 days of receipt of a renewal application, the department shall inform the organization in writing that the renewal application is complete and accepted for review, or deficient and what specific information or documentation is required to complete the application.
(3) Within 30 days of receiving a completed renewal application, the department shall inform the applicant organization in writing whether the examination has been reapproved or denied.
(d) Failure to meet and maintain the requirements of this section shall be good cause for denial of reapproval by the department.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1208, 1228, 1261, 1261.5, 1262, 1263 and 1264, Business and Professions Code.


s 1032. Examination for Clinical Laboratory Technologist's License.
With the exception as provided in Section 1262 of the Business and Professions Code, written, oral, or practical examinations shall be conducted by the department to aid it in judging the qualifications of applicants for licensure as clinical laboratory technologists. In addition to the requirements for licensure as specified in Section 1261 of the Business and Professions Code, the prerequisites for entrance into the licensing examination shall be one of the following:
(a) Graduation from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges, or an essentially equivalent accrediting agency, with a baccalaureate and a major in clinical laboratory science, the last year of which course shall have been primarily clinical laboratory procedures in a clinical laboratory training school acceptable to the department; or
(b) Graduation from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Eastern Association of Schools and Colleges, or an essentially equivalent accrediting agency, with a baccalaureate and courses pertinent to the clinical laboratory field as may be determined by the department plus one year as a clinical laboratory technologist trainee or the equivalent as determined by the department in a clinical laboratory acceptable to the department; provided, however, that a baccalaureate obtained after July 1, 1973, must include at least:
(1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry;
(2) 18 semester or equivalent quarter hours of biological science, including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology;
(3) 3 semester or equivalent quarter hours of physics, including instruction in principles of light and electricity; or
(c) A minimum of two years of experience as a licensed trainee or the equivalent as determined by the department doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory acceptable to the department and 90 semester hours or equivalent quarter hours of university or college work in which are included the following coursed, or essential equivalent as may be determined by the department: general inorganic chemistry -8; quantitative analysis -3; basic biological sciences -8; bacteriology -4; provided, however, that university or college work completed after July 1, 1973, must include at least:
(1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry;
(2) 18 semester or equivalent quarter hours of biological science including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology;
(3) 3 semester or equivalent quarter yours of physics, including instruction in principles of light and electricity.


Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 1246, 1261, 1262, 1263, 2164 and 1301, Business and Professions Code.


s 1032.5. Licensure of Medical Laboratory Technicians.
(a) In order to qualify for licensure as a medical laboratory technician, a person shall apply for a license pursuant to Section 1031.4 (b) and meet the following requirements:
(1) Have successfully completed at least 60 semester (90 quarter) units from an accredited college or university. The coursework shall consist of at least 36 semester units of physical and biological sciences with an emphasis on applied clinical science. Coursework shall include 6 semester units of chemistry and 6 semester units of biology appropriate for transfer to a baccalaureate program in science, taken prior to, or concurrently with, training or experience; and
(2) Have met the following training or experience requirements by documenting one of the following:
(A) Graduating from a medical laboratory technician training program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS); or
(B) Graduating from a medical laboratory technician training program approved by the department pursuant to Section 1035.3; or
(C) Meeting admission requirements for a clinical laboratory scientist licensing examination, as determined by the department pursuant to Section 1032; or
(D) Completing a minimum of three years on-the-job practical experience within the previous five years, in a clinical laboratory outside California as a medical laboratory technician, with evidence of satisfactory performance on an examination given by a certifying organization for medical laboratory technicians, performing tests in the specialties of chemistry, hematology, microbiology, and immunology. This work experience shall include at least 480 hours in each of these specialties and shall be documented by the laboratory director(s) of the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); or
(E) Completing a minimum of three years on-the-job practical experience within the previous five years, in a clinical laboratory outside California as a clinical laboratory scientist, with evidence of satisfactory performance on an examination given by a certifying organization for clinical laboratory scientists, performing tests in the specialties of chemistry, hematology, microbiology, and immunology. This clinical laboratory scientist, also called medical technologist in some states, need not be California licensed pursuant to Business and Professions Code section 1204, but shall have work experience outside California of at least 480 hours in each of these specialties as documented by the laboratory director(s) of the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); or
(F) Completing a minimum of three years on-the-job practical experience within the previous five years, as a medical laboratory technician or clinical laboratory scientist in a California physician office laboratory or in a laboratory owned and operated by the United States of America. This person shall have evidence of satisfactory performance on an examination given by a certifying organization for medical laboratory technicians or clinical laboratory scientists, respectively, and have performed tests in the specialties of chemistry, hematology, microbiology and immunology. This work experience shall include at least 480 hours in each of these specialties, and shall be documented by the physician(s) directing the laboratory(ies) employing the applicant pursuant to Section 1031.4(b)(8); and
(3) Have passed a written examination for medical laboratory technicians administered by a certifying organization for medical laboratory technicians approved by the department pursuant to Section 1031.8. The department shall, for licensure purposes, accept evidence of satisfactory performance on examinations taken within the four years previous to department approval of a certifying organization's medical laboratory technician examination. The applicant shall have also passed a separate written, self-administered examination on California clinical laboratory law provided by the department. This self-administered test shall accompany the application. A minimum passage rate of 70 percent shall be required.
(b) A licensed medical laboratory technician shall be authorized to:
(1) Perform tests and examinations classified as waived and moderate complexity by Centers for Disease Control and Prevention in the specialties of chemistry, including routine chemistry, urinalysis, endocrinology and toxicology; hematology including coagulation; microbiology, including bacteriology, mycobacteriology, mycology, parasitology and virology; and immunology, including syphilis serology and general immunology, with the exception of those moderate complexity tests requiring microscopy, or in the specialty of immunohematology.
(2) Perform phlebotomy, but shall not perform skin tests for specific diseases pursuant to Section 1242 of the Business and Professions Code.
(3) Perform tests and examinations under the supervision of a licensed physician and surgeon, or a doctoral scientist, clinical laboratory bioanalyst, clinical laboratory scientist, or clinical laboratory specialist licensed under Chapter 3. On-site supervision shall be required during the entire time the medical laboratory technician performs moderate complexity clinical laboratory tests or examinations. The ratio of medical laboratory technician to supervisor at the site of moderate complexity testing shall not exceed four to one.
(4) Report test results and perform phlebotomy only after competency has been documented by the laboratory director pursuant to Section 1209(e) of the Business and Professions Code.
(5) Supervise Limited Phlebotomy Technicians or Certified Phlebotomy Technician Is.
(c) The license application fee and license renewal fee for a medical laboratory technician shall be the same as the license application fee and license renewal fee for a clinical laboratory scientist pursuant to Section 1300(c) and (e) of the Business and Professions Code.
(d) A medical laboratory technician shall complete twelve hours of continuing education each year as a condition for renewal.


Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1202.5, 1204, 1206, 1206.5, 1208, 1209, 1210, 1242, 1260.3, 1261, 1275, 1300 and 1320, Business and Professions Code.


s 1033. Trainee Requirements.
In addition to the requirements for licensure as specified in Section 1263 of the Business and Professions Code, the prerequisites for licensure as a trainee shall be as follows:
(a) Clinical Laboratory Technologist Trainee. Applicants shall have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent agency with a baccalaureate and a major in clinical laboratory science, or a baccalaureate and courses pertinent to the clinical laboratory field as may be determined by the department. An individual who is not a graduate but possesses at least 90 semester hours or equivalent quarter hours of university or college work may be licensed as a clinical laboratory technologist trainee, provided he will be granted a baccalaureate at the conclusion of 12 months of training, and have completed at least 90 semester hours or equivalent quarter hours, must have included in the college work the following courses or essential equivalent as may be determined by the department: general inorganic chemistry -8; quantitative analysis -3; basic biological sciences -8; bacteriology -4; provided, however, that university or college work completed after July 1, 1973, must include at least:
(1) 16 semester or equivalent quarter hours of chemistry, including instruction in analytical and biological chemistry;
(2) 18 semester or equivalent quarter hours of biological science, including instruction in immunology, hematology and medical microbiology which may include bacteriology, mycology, virology and parasitology;
(3) 3 semester or equivalent quarter hours of physics including instruction in principles of light and electricity.
(b) Limited Technologist Trainee. Applicants shall have graduated from a college or university maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency with a baccalaureate and a major in the specialty for which licensure is sought. If the major is not designated by the college or university as one of those required under this chapter for limited technologist licenses in clinical chemistry, clinical microbiology, immunohematology, or toxicology, the department may determine the essentially equivalent major.


Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: sections 1246, 1261, 1262, 1263, 1264 and 1301, Business and Professions Code.


s 1034. Certification of Phlebotomy Technicians.
(a) The education, training and experience required for certification in phlebotomy shall be as follows:
(1) For a person to be eligible for certification as a Limited Phlebotomy Technician, he or she shall:
(A) Be a high school graduate or have achieved a passing score on the general educational development (GED) test or documentation of equivalent education pursuant to Section 1031.4(c)(6)(B); and
(B) Have completed a minimum of 20 hours basic didactic instruction pursuant to Section 1035.1(e)(1) from a phlebotomy training program approved by the department; and
(C) Have completed a minimum of 25 skin punctures, performed pursuant to the Business and Professions Code Section 1220(d)(1) or (d)(2)(A) that fulfill all sampling requirements of all clinical laboratory tests or examinations, in a clinical setting on patients, under the supervision of a licensed physician and surgeon, licensed physician assistant, licensed clinical laboratory bioanalyst, registered nurse, or licensed clinical laboratory scientist, who will certify in writing with a signed certificate that this training has been completed; and (continued)