1. HuQAS SCIENTIFIC CONFERENCE
SLMTA LABORATORIES STABILITY POINT AND APPLICATION FOR ACCREDITATION Maryanne A. Otieno Quality and Compliance Associate
HuQAS SCIENTIFIC CONFERENCE
18th September KENYA

2. introduction
The Foundation has mentored 15 laboratories in Kenya on Strengthening Laboratory Management Towards Accreditation (SLMTA)
The laboratories went through 4 Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Checklist audits.
One of the laboratories has since been accredited, another one has been recommended for accreditation and one has recently applied for accreditation.
The other 12 have shown remarkable quality improvement as evidenced from the assessments

3. STABILITY POINT AND APPLICATION FOR ACCREDITATION
The study evaluated if laboratories need to attain a SLIPTA 5 star level rating to apply for accreditation by evaluating the following:
The stability point of the laboratories;
The field mean of the laboratories and
Weakest performing Quality System Essentials (QSEs).

4. methods
Four audits (Baseline, Mid-term and End-term) were conducted 6 months apart and a Surveillance audit conducted 11 months post SLMTA, with limited mentorship to the laboratories (cohort 2 laboratories).
The stability point was gotten by analyzing the average performance of the laboratories between audits.
The X moving R chart was used to determine the field mean and also weakest performing QSEs across all laboratories.

5. methods
The X moving R chart Monitors the variation of QSEs performance over time.
The field mean focuses on the laboratories performance over time and it’s corrective actions to non conformities.
The following formulas were used to calculate the field mean and generate the X moving R chart data:
X chart
Mean =
R chart
UCL=
LCL=

6. Results- Stability point graph
% Improvement between assessments were 36.6%, 2.1% and -1.7% respectively. The average SLIPTA percent rating in these last two periods was 72% hence the Stability Point.

7. RESULTS- X MOVING R CHART
A total of 684 data points was analyzed to generate the X moving R chart
Bungoma
KNH- Bio
KNH-Micro
Mathari
Meru
Murang'a
Thika
Kisii
Baseline
Midterm
End term
Surveillance
mean
QSE 1 28 72
100 92 12 96 20 64 80 76 88 68 52 56 84 62 16 40 44 -8 60 24 -4
-24
-12 4
-22
-48
QSE 2 25 67 47 33 42 17 35 8 50
-20 34
-25 58 5 10
-11
-43
QSE 3 85 70 90 15 65 75 45 55
-15 3 30
-30
-10
QSE 4 13 63 87 38
-13
QSE 5 57 93 77 73 97 53 83 27 37 36
-16
-14
-26
QSE 6
-40
-90
-80
QSE 7 -3
-33 -5 -1
-27
QSE 8 23 26 79 21 71 29 61 86 7 48 74 9 19
-19 22 14
-21
QSE9 78 39 94 89
-32
-17 11 2 18
-49
QSE 10 41 -9
-34
-63
QSE 11
-83 66
-42
QSE 12 95 91
-18
“Improving the quality of life”

8. results
field mean = 60%
QSEs below the mean are: QSE 2, QSE 6, QSE 10, and QSE 11

9. conclusion
The field mean of 60% reflects the statistical control point for decision-making as to if a laboratory is prepared to apply for accreditation and the actions required for success.
The results from 15 laboratories show a stability point of 72% indicating key quality improvement processes have been achieved and technical requirements implemented by addressing non conformities in the QSEs.

10. conclusion Stability Point of 72% = ACCREDITABLE LABORATORY
Field mean of >60% = ACCREDITABLE LABORATORY

11. Thank You CDC HuQAS SLMTA Labs All Conference Participants
The Foundation’s Associate’s