CA Lab Personnel Law Time For A Change

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CA Lab Personnel LawTime For A Change??

• California Department of Public Health
• Laboratory Field Services
• August 24, 2009

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What does CA law require?
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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.

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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.

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What does CA law require for
licensure?

• Education requirements BPC
  1260 - 1264.
• Associate or equivalentMLT.
• BS in science for CLS, limited CLS.
• MS/PhD in science for non-physician
• directors.

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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.

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What does CA law require?

• Examination requirements in CAExam 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.

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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.

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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.

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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.

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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

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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.

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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

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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.

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Issues to consider

• The ratio of MLT to supervisor is 41.
• 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

• 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

• 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.

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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.

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Issues to consider

• The ratio of licensed trainee to licensed trainer
  is 21.
• Proposal Is this necessary??
• Impact Current requirement may limit training
  programs.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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We need your input and comments

• Please send us your written comments by email to
  lfsrecep_at_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 ..