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§ 1031.8. Conditions for Approval of a Certifying Organization to Administer a Certifying Exami...


Barclays Official California Code of Regulations Currentness
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 (Refs & Annos)
17 CCR § 1031.8
§ 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.
1. New section filed 1-13-2005 as an emergency; operative 1-13-2005 (Register 2005, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-13-2005 or emergency language will be repealed by operation of law on the following day.
2. New section refiled 5-12-2005 as an emergency; operative 5-14-2005 (Register 2005, No. 19). A Certificate of Compliance must be transmitted to OAL by 9-12-2005 or emergency language will be repealed by operation of law on the following day.
3. Certificate of Compliance as to 5-12-2005 order, including amendment of subsections (a)(12), (a)(17), (a)(20), (a)(25) and (b) and repealer of subsection (c) with subsection relettering, transmitted to OAL 8-3-2005 and filed 9-12-2005 (Register 2005, No. 37).
This database is current through 1/7/22 Register 2022, No. 1
17 CCR § 1031.8, 17 CA ADC § 1031.8
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