Post-examination QA Procedures in C&DST Laboratories

Post-examination QA Procedures in C&DST Laboratories

Post-examination (also post-analytical phase) is one of the three-phase frameworks for the total testing process to describe issues related to the quality of laboratory testing. Most common laboratory errors occur following the testing of the sample, and some of these may be more difficult to detect. Common examples of these errors include making a transcription error when preparing the report; sending the report to the wrong location, which often results in complete loss of the report; failing to send the report.

All the C&DST laboratories should have procedures in place to ensure the validation of post-examination processes in the laboratory. These include:

• Validation of the results: In this procedure, a review is done to verify that all the data and results in the Result Report have correctly been transcribed from the Request Form, the work forms, and the register. It must also be verified that results are legible and that quality controls were correctly performed on the day the results were produced (to determine if the examinations were performed correctly and that reagents and equipment were performing correctly). The person authorized to perform this procedure must be somebody in a management position (either the head of the data management section, the head of the section where the testing was performed or the laboratory manager him/herself).

• Delivery of reports: All the C&DST laboratories should have a written protocol for sending the Result Reports to the requesters. There are two important requirements for choosing a method of sending the results: the method of sending Result Reports must have a minimal risk of losing Result Reports, and the Result Reports must always be transmitted promptly. Under NTEP, all C&DST laboratories should use the web-based portal- Ni-kshay- to send test reports. However, an alternative method should also be kept as a backup in case Ni-kshay does not work. In addition, all the C&DST laboratories should write a detailed SOP for the same. 

• Turn-around-Time (TAT): NTEP has already defined the TAT for all the diagnostics tests. The C&DST laboratory should be able to complete the test requested and report the results in Ni-kshay within the defined TAT. Periodic reviews should be done to ensure that the results are reported within the permissible TAT. The person authorized to perform this procedure must be somebody in a management position.

• Result audit: Periodic internal audits should be done & documented by the C&DST laboratory on the results reported. These audits should include the entire pathway of the laboratory activities, from validating results to reporting the results in Ni-kshay.

Resource

Laboratory quality management system: Handbook. World Health Organization

Assessment