California Code of Regulations › Title 17 - Public Health › Division 1 - State Department of Health Services › Chapter 2 - Laboratories › Subchapter 1 - Service Laboratories › Group 2 - Clinical Laboratory Regulations › Article 1.5 - LICENSURE OF CLINICAL LABORATORY PERSONNEL › Section 1031.8 - Conditions for Approval of a Certifying Organization to Administer a Certifying Examination for Licensure Purposes

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.