Moderate Complexity Testing Overview:
What must a physician or local health department do to
perform moderate complexity testing under the Clinical
Laboratory Improvement Amendments of 1988
(CLIA)? |
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Enroll in the CLIA program:
1. Complete an Application for Certification
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Description of laboratory to include name and number of tests performed annually, methodologies for each test,
personnel qualifications, etc.
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Submit application (signed by the director) to the State
Agency CLIA Contact
- Certificate valid for 2 years.
2. Pay fee
- Fee based on the annual volume and types of testing performed (for
small laboratories fee is about $150 for the 2 year period).*
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Satisfy CLIA technical requirements for moderate complexity testing:
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Personnel |
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Director: |
Responsible for the overall management and
direction of the laboratory but does not have to be on-site at all times.
Broad range of experience and education acceptable. For example, a
physician with 1 year of experience directing/supervising a non-waived
laboratory or 20 CMEs in laboratory practice would qualify, as would a
person with a bachelor's degree and 2 years laboratory training/experience
plus 2 years supervisory experience in non-waived testing. The director
could, depending on education and experience, qualify for all other
positions.
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Testing personnel: |
Responsible for specimen processing, test
performance and reporting test results. Minimum requirement is a high
school diploma or equivalent and training for the testing performed.
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Technical consultant: |
Responsible for the technical and scientific
oversight of the testing. Minimum requirement a bachelor's degree with 2
years laboratory training or experience in non-waived testing.
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Clinical consultant: |
Provides clinical consultation. Minimum
requirement a doctoral degree with board certification.
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NOTE: The director, technical consultant,
and clinical consultant are not required to be on-site at all times of
testing.
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Quality Management:
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Your laboratory will need to:
- Have procedures that assure proper patient preparation, specimen
identification and integrity; and monitor and evaluate the testing
process and quality management system.
- Have a procedure manual (manufacturer's package insert may be
acceptable).
- Follow manufacturer's instructions for performing the test.
- Test a positive and negative control each day patient samples are
tested (package insert may provide flexibility).
- Enroll and participate in proficiency testing (if available).
- Identify and correct problems, and record remedial actions
taken.
- Maintain test requests and laboratory records for 2 years.
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Undergo biennial inspection:
- Laboratory may choose to have inspections conducted by either CMS or private accrediting organizations.
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*To reduce cost, consider limited public health
certification (if
eligible).
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| CLIA regulations
(fully linked version) |
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