Each medical facility and laboratory operating in the United States must have a designated administrator who is responsible for managing the day-to-day operations of the laboratory. This includes maintaining documentation, staff training, developing policies and procedures, ensuring compliance with CLIA regulations, monitoring quality assurance practices, and staying current on any changes to CLIA regulations.
2. Laboratory Personnel:
The laboratory personnel must be qualified and trained in order to ensure accuracy and integrity of the results produced by the laboratory. The facility must maintain documentation that outlines each employee's qualifications and responsibilities, as well as records of any training completed or additional education received.
3. Laboratory Written Policies, Procedures, and Records:
Each laboratory must have written policies, procedures, and records which outline how tests are conducted, monitored, and maintained. The records should include all test protocols and methods used when testing samples from patients.
4. Quality Assessment/Quality Assurance:
The facility must have a quality assessment plan in place to evaluate the performance of personnel in relation to CLIA regulations. This includes identifying any deficiencies in laboratory practices and procedures, as well as implementing corrective action when necessary. The facility must also perform internal quality assurance tests to ensure accuracy of results produced by the laboratory.
5. Proficiency Testing Records:
The facility must maintain records from proficiency testing (PT) performed in order to assess the competence of personnel and accuracy of the test results produced by the laboratory. PT is a requirement for all laboratories performing tests on specimens from patients and should be conducted regularly.
6. Laboratory Systems Calibrations and Verifications:
In order to ensure accuracy of the laboratory equipment and instruments, calibrations and verifications must be performed at regular intervals. This includes checking and adjusting the parameters of all systems for optimal performance. Documentation must be maintained for each calibration and verification performed in the laboratory.
7. Laboratory Quality Controls:
The facility must have documented quality control procedures in place to monitor test accuracy and integrity. This includes regularly measuring and evaluating the accuracy of results produced by the laboratory, as well as verifying that procedures are being followed correctly when performing tests on patient specimens.
8. Testing Records:
All testing processes conducted in the laboratory must be properly documented in order to demonstrate compliance with CLIA regulations. This includes maintaining records of specimen collection, transportation, storage, analysis, reporting, and any other activities related to producing accurate test results from patient specimens.
9. Laboratory Maintenance Records:
The facility must maintain records of all maintenance and calibration performed in the laboratory to ensure accuracy and safety of equipment and instruments used in testing patient specimens. This includes regular inspections, cleaning schedules, repairs or replacement of any parts, and documentation for each process performed by qualified personnel.
10. Temperature Controlled Spaces, Equipment, and Instruments:
The CLIA regulations require that laboratories have adequate temperature control systems in place for all areas where tests are conducted on patient specimens. This includes maintaining a consistent temperature range in order to protect the integrity of the samples being tested. Documents should be maintained to indicate that temperatures are being monitored regularly throughout the laboratory areas.
11. Laboratory testing - Area, supplies and safety requirements:
The CLIA regulations require that laboratories have adequate area, supplies, and safety measures in place for tests conducted on patient specimens. This includes having the proper equipment and space to conduct tests, as well as ensuring all personnel are trained in laboratory safety protocols. Documents should be maintained to indicate that these requirements are being met.