CLIA Personnel Requirements and Responsibilities

High Complexity Laboratories

1.Qualified Lab Director or Technical Supervisor of high complexity testing OR;

2. Licensed MD/DO/DPM, or have a Doctoral, Master’s, or Bachelor’s degree in lab science AND 1 year laboratory training or experience in high complexity testing OR;

3. Qualified as Testing Personnel for high complexity testing AND at least 2 years laboratory training or experience in high complexity testing OR;

4. Previously qualified as General Supervisor on or before 02/28/1992 OR;

5. Prior to 09/01/1992, served as General Supervisor of high complexity testing AND prior to 04/24/95 completed military Medical Lab Specialist (50 week course) AND had at least 2 years lab training or experience in high complexity testing OR graduated from an HHS-approved lab training program AND had at least 2 years lab training or experience in high complexity testing OR;

6. Prior to 09/01/1992, served as General Supervisor of high complexity testing AND have a high school diploma or equivalent AND more than 10 years of experience in high complexity testing including at least 6 years supervisory experience from 09/01/1982 to 09/01/1992 OR;

7. Prior to 09/01/1992, served as General Supervisor of high complexity testing and prior to 01/01/1994: passed an HHS approved technical proficiency exam given between 03/01/1986 and 12/31/1987 AND have 6 years lab training or experience with 2 years in high complexity testing specialties

Moderate Complexity Laboratories

Position Not Needed

General Requirements

1. Is accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic support

2. Provides day to day supervision of personnel performing high complexity testing

3. Must be on-site to provide direct supervision when high complexity testing is performed by certain individuals

4. Monitors test analyses and specimen examination to ensure that acceptable levels of analytic performance are maintained

5. Fulfills certain responsibilities as delegated by the Lab Director and/or Technical Supervisor. These may include:

   1. Resolving technical problems and ensuring corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications

   2. Ensuring patient test results are not reported until all corrective actions have been taken and the test system is functioning properly

   3. Providing orientation to all testing personnel

   4. Evaluating and documenting the performance of all testing personnel as required