CA Lab Personnel Law— Time For A Change?? California Department of Public Health Laboratory Field...
-
date post
20-Jan-2016 -
Category
Documents
-
view
216 -
download
0
Transcript of CA Lab Personnel Law— Time For A Change?? California Department of Public Health Laboratory Field...
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
[email protected] • 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 ..