Quality essentials and cited non-conformities | Number of facilities with non-conformities | |||
Q1 | Q2 | Q3 | Q4 | |
Documents and records |
| |||
SOPs not signed by relevant Lab personnel | 12 | 10 | 8 | 0 |
Organization and personnel | ||||
No organogram | 10 | 7 | 5 | 3 |
No staff folders, job description, certificates of training and other relevant documents not found in staff folders | 11 | 9 | 5 | 6 |
Internal and external quality control | ||||
No internal quality control records and L-J chart not plotted | 20 | 16 | 12 | 10 |
Non-participation in at least one External quality control CD4 count | 20 | 1 | 0 | 0 |
Internal audit was not conducted by facility quality officer | 16 | 13 | 10 | 9 |
No CAPA documentation of poor external quality control and internal quality control performance | 10 | 5 | 4 | 0 |
Inventory control system | ||||
Tally cards not updated for lab reagents and consumables | 14 | 6 | 4 | 3 |
Ambient and refrigerating temperature not monitored | 14 | 0 | 2 | 4 |
Equipment | ||||
Operators' equipment daily maintenance charts not updated and reviewed | 19 | 6 | 6 | 5 |
Facilities and safety | ||||
PEP guideline with designated contact person not available | 10 | 5 | 2 | 4 |
Signage/bench top references | ||||
No food, no drink or no food, no drink picture format not t displayed | 10 | 8 | 10 | 9 |
Unauthorized person not allowed sign not displayed | 11 | 7 | 10 | 9 |
No separate sample collection/phlebotomy area | 10 | 7 | 5 | 5 |