CA Lab Personnel Law—Time For A Change??

California Department of Public Health

Laboratory Field Services

August 24, 2009

What does CA law require?

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

(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

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.

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.

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.

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.

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

(7) 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

(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.

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.

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.

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.

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

(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.

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

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.

• 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 ..