(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.
Credits
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.
