The CLIA88 regulations in Subpart M describe the role of a Technical Consultant for moderately complex testing (or similarly a Technical Supervisor for highly complex testing). That person must provide technical and scientific oversight of the laboratory. He/she does not need to be on site at all times but must be available on an as needed basis either on site, by telephone or electronically. The Technical Consultant does not need to be the Laboratory Director, but like the Clinical Consultant role, the Laboratory Director is frequently designated as the Technical Consultant and his or her role is also probably strengthened by taking on this responsibility. Most broadly trained pathologist Laboratory Directors should be able to assume this role for POCT and any POCT director should understand these duties.
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- Duties of the Technical Consultant include:
- Test Method Selection
- Method Validation and Verification Protocols
- Proficiency Testing
- Quality Control Challenges
- POCT connectivity and data management
- Patient Safety and POC
- Staff Training and Competency repeat competency assessment 6 months after initial evaluation for new technical staff and every 12 months thereafter and maintenance of competency elements
- For waived testing, not all of these duties are required, BUT, not all POCT is waived testing, AND, best laboratory practices should be included in the selection and oversight of ANY testing. As previously noted, various professional bodies, states, and nations require all of the technical elements of non-waived testing to be applied to waived testing.
- This section includes details addressing most of the above duties. Some of the information may not be applicable for waived testing under CLIA88. Rather, the information provides for best practices for any type of laboratory testing, and is useful information for a Laboratory Director in any setting. As noted previously, many of the functions can overlap with the sections on the Laboratory Director and Clinical Consultant. However, they are included here because they address many technical operations and are presented in some detail.