CA Lab Personnel Law—Time For A Change?? California Department of Public Health Laboratory Field Services August 24, 2009
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
Issues to consider • 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
Issues to consider • 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.
Issues to consider • 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.
Issues to consider • 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.
Some issues to consider • 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.
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.
Issues to consider • The ratio of licensed trainee to licensed trainer is 2:1. Proposal: Is this necessary?? Impact: Current requirement may limit training programs.
Issues to consider • 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.
Issues to consider • 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.
Issues to consider • 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.
Issues to consider • 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.
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.
Issues to consider • 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.
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.
We need your input and comments • Please send us your written comments by email to firstname.lastname@example.org • 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. • 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 ..