CLIA Personnel Requirements and Responsibilities

High Complexity Laboratories

Immunology, Chemistry, Hematology, or Radiobioassay:

1. Licensed MD/DO.DPM or Ph.D. AND certified in clinical pathology OR 1 year lab training or experience in the high complexity testing specialties performed OR;

2. Master’s degree in lab science AND 2 years lab training or experience in the high complexity testing specialties performed OR;

3. Bachelor’s degree in lab science AND 4 years lab training or experience in the high complexity testing specialties performed

Microbiology subspecialties – bacteriology, mycobacteriology, mycology, virology, and parasitology:

1. Licensed MD/DO/DPM or PhD AND certified in clinical pathology OR 1 year lab training or experience in high complexity microbiology with a minimum of 6 months in subspecialty of service OR;

2. Master’s degree in laboratory science AND 2 years lab training or experience in high complexity microbiology with a minimum of 6 months in subspecialty of service OR;

3. Bachelor’s degree in laboratory science AND 4 years lab training or experience in high complexity microbiology with a minimum of 6 months in subspecialty of service

Immunohematology:

1. Licensed MD/DO/DPM AND certified in clinical pathology OR 1 year lab training or experience in immunohematology testing

Moderate Complexity Laboratories

Position Not Needed

General Requirements

Must be available to provide needed consultation either on-site, by telephone, or electronically

Selects test methodology appropriate for the clinical use of the test menu

Verifies procedures for testing performed and establishes the laboratory’s performance criteria, including accuracy and precision of each test and test system

1. Enrolls the laboratory in an approved PT program commensurate with services offered

2. Establishes a quality control program appropriate for the testing performed, establishes the acceptable levels of analytic performance, and ensures these levels are maintained throughout the testing process

3. Resolves technical problems and ensures corrective actions are taken when- ever test systems deviate from the laboratory’s established performance specifications

4. Ensures patient test results are not reported until all corrective action has been taken and the test system is functioning properly

5. Identifies training needs and ensures testing personnel receive regular in-service training

6. Evaluates the competency of all testing personnel on an ongoing basis

7. Evaluates and documents Testing Personnel’s performance at six months and twelve months during the first year of employment and yearly thereafter. Performance is reevaluated (prior to reporting patient test results) if test methodology or instrumentation changes. The evaluation must include the use of the new test methodology or instrumentation