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