1. CA Lab Personnel Law— Time For A Change?? California Department of Public Health Laboratory Field Services August 24, 2009

2. What does CA law require?

3. Who can do tests? All testing personnel must be licensed or otherwise authorized to do testing BPC 1206.5. Licensed persons are authorized to perform tests within their scope of work. Others are authorized to perform tests in specific work settings only.

4. What about the others? A person not licensed is UN-licensed and has restricted activities BPC 1269. Requires direct and constant supervision May assist a licensed person. May not perform a test involving quantification or measurement, do calibrations, take readings.

5. What does CA law require for licensure? Education requirements BPC 1260 - 1264. Associate or equivalent—MLT. BS in science for CLS, limited CLS. MS/PhD in science for non-physician directors.

6. What does CA law require? Training requirements, in CA--- Requires a trainee license BPC 1205. Must train in an approved lab BPC 1286. One-year training for BS-level candidates. BPC 1261.5. Two-years training + two-years experience for non-physician candidates. BPC 1264.

7. What does CA law require? Examination requirements in CA—Exam administered or approved by Department BPC 1261-64. Approved certification exam. Self-administered quiz on state law for Associate and BS applicants Oral exam on state and federal law for Doctoral-level applicants.

8. Other requirements in law The Department may approve schools accredited by NAACLS BPC 1222. License categories have defined workscopes BPC 1203, 1204, 1207. MLT workscope is limited to W, M testing, no immunohem or microscopics BPC 1260.3.

9. Why is this important? Standards in statute (Business and Professions or Health and Safety Codes) cannot be changed without legislation. Standards in regulation (California Code of Regulations) can be changed thru public input to a government agency which makes changes via the regulatory process.

10. Public Concern There is a labor shortage of qualified testing personnel in CA. It is difficult to get licensed in CA because of artificial barriers and antiquated requirements. Qualified persons outside CA cannot meet licensure requirements, cannot work in CA.

11. LFS Proposal Use CLTAC* position papers and public input to update licensing regulations. Maintain standards set in law since 1950s. Ease application processing. Simplify requirements as possible. Recognize new technologies and expanded work scopes. * Clinical Laboratory Technology Advisory Committee

12. Some issues identified Not enough training programs. Difficulty approving out-of-state applicants. Difficulty post doctorate candidates have getting training in CA. Many specialist licenses have limited work scopes, including MLTs. Expanding need for genetic scientists.

14. Issues to consider (1) NAACLS*-accredited training programs are not accepted for licensure in CA. Proposal: Accept NAACLS. Impact: Facilitate approval of training for some applicants in and outside CA. Concern about length of training. * National Accrediting Agency for Clinical Laboratory Sciences

15. Issues to consider (2)The four-year look back of certification exam approval requires older certificants to take the exam again. Proposal: Retain look back which was based on public comments to regs. Impact: Applicants thereby demonstrate current, broad knowledge of specialties.

16. Issues to consider (3)The ratio of MLT to supervisor is 4:1. Proposal: Retain as this was established based on public comments to regs. Impact: MLTs can work without CLS supervision for Waived tests, but need supervision for Moderate tests.

17. Issues to consider (4)Recognition of post doctorate trainees in CA is difficult Proposal: Adopt post doctoral trainee license to allow testing, position recognition. Impact: Streamlines and clarifies pathway of post doctorates to licensure in CA.

18. Some issues to consider (5)Training for specialist license must be done in a CLIA-certified, LFS-approved lab. Proposed: ILAC-certification for non-US, retain CLIA-certified requirement for US. Impact: Increases specialist license applicants from non-US. Does not allow on the job, research or non-clinical lab experience. Restricts applicants from non-traditional sites.

19. Issues to consider (6) An unlicensed person is not authorized to train a licensed trainee. Proposal: An approved program can designate an unlicensed person to train. Impact: This shall allow doctoral scientists, vendors, professors to participate in training.

20. Issues to consider (7)The ratio of licensed trainee to licensed trainer is 2:1. Proposal: Is this necessary?? Impact: Current requirement may limit training programs.

21. Issues to consider (8)There is no transition for MLTs to CLS licensure. Proposal: BS degree required and 6-month additional training program. Impact: This may facilitate articulation of MLTs to CLS licensure.

22. Issues to consider (9)A licensed cytotechnologist is limited to gyn and non-gyn cytology. Proposal: Expand their workscope to include FISH, HPV, Immunohisto- chemical staining by microscopic analysis. Impact: Expands work scope for qualified cytotechs.

23. Issues to consider (10) A licensed clinical genetic molecular biologist is limited to genetic tests on humans. Proposal: Redefine “clinical genetic molecular biology tests” to include infectious diseases, metabolic tests and others. Impact: Expanded workscope.

24. Issues to consider (11) Persons with specialist licenses have designated work scopes. Proposal: Continue to require approved training and second license. On the job training in another specialty is not practical. Impact: Difficulty in expanding work scopes. Retains quality of training.

25. Issues to consider (12) Certification of histotechs is not recognized. Proposal: Recognize certification with less required supervision. Impact: Certified histotechs will be able to work under general rather than direct supervision.

26. Issues to consider (13) A CPT who works at multiple locations for the same employer must post the certificate at each location. Proposal: Certificate posted at primary location, copies authorized elsewhere for same employer. Duplicates for second employer. Impact: Reduce cost while providing proof of certification.

27. Issues to consider (14) Doctoral embryologists cannot perform lab tests in CA. Proposal: Establish licensing standards for clinical embryologists doing clinical lab tests. Impact: Improved employability of qualified persons in CA.

28. We need your input and comments Please send us your written comments by email to lfsrecep@cdph.ca.gov Insert “Comments” in the Subject line of the email containing your input This presentation will be provided on our website at http://cdph.ca.gov/lfs with a separate document that lists the14 Specific Issues from slides 14-27. http://cdph.ca.gov/lfs Organize your comments by each Specific Issue number, 1-14, as given in the presentation Comments and input must be 500 characters or less, per each Specific Issue Due date: COB Sept. 4, 2009..