TABLE 2.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Requirements Related to Laboratory Safety
| Regulation | Description |
|---|---|
| Facilities | |
| §493.1101 (a) (1) | The laboratory must be constructed, arranged, and maintained to ensure the following: the space, ventilation, and utilities necessary for conducting all phases of the testing process. |
| §493.1101 (a) (2) | The laboratory must be constructed, arranged, and maintained to ensure the following: contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. |
| §493.1101 (b) | The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. |
| §493.1101 (c) | The laboratory must be in compliance with applicable Federal, State and local laboratory requirements. |
| §493.1101 (d) | Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. |
| Maintenance and function checks | |
| §493.1254 (a)(1)(2) | The laboratory must perform and document: (i) Maintenance as defined by the manufacturer and with the frequency specified by the manufacturer. (ii) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer’s established limits before patient testing is conducted. |
| Laboratory director responsibilities | |
| For moderate-complexity testing | |
| §493.1407 (e) (2) | The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. |
| §493.1407 (e) (10) | Employ a sufficient no. of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report tests results in accordance with the personnel responsibilities described in this subpart. |
| §493.1407 (e) (11) | Ensure that prior to testing patient’s specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. |
| §493.1407 (e) (12) | Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. |
| For high-complexity testing | |
| §493.1445 (e) (2) | The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. |
| §493.1445 (e) (11) | Employ a sufficient no. of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report tests results in accordance with the personnel responsibilities described in this subpart. |
| §493.1445 (e) (12) | Ensure that prior to testing patient’s specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. |
| §493.1445 (e) (13) | Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. |