HuQAS SCIENTIFIC CONFERENCE SLMTA LABORATORIES STABILITY POINT AND APPLICATION FOR ACCREDITATION Maryanne A. Otieno Quality and Compliance Associate HuQAS SCIENTIFIC CONFERENCE 18th September 2014 -KENYA

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

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).

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.

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=

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.

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 60.96774194 44 -8 60 24 -4 -24 -12 4 -22 -48 16.95652174 QSE 2 25 67 47 33 42 17 35 8 50 43.96774194 -20 34 -25 58 5 10 -11 -43 17.56521739 QSE 3 85 70 90 15 65 75 45 55 69.74193548 -15 3 30 -30 -10 13.39130435 QSE 4 13 63 87 69.83870968 38 -13 22.73913043 QSE 5 57 93 77 73 97 53 83 27 37 66.61290323 36 -16 -14 -26 9.565217391 QSE 6 42.90322581 -40 -90 -80 6.52173913 QSE 7 70.22580645 -3 -33 -5 -1 -27 4.583333333 QSE 8 23 26 79 21 71 29 61 86 7 48 63.93548387 74 9 19 -19 22 14 -21 9.043478261 QSE9 78 39 94 89 63.38709677 -32 -17 11 2 18 -49 8.695652174 QSE 10 41 44.19354839 -9 -34 -63 QSE 11 45.64516129 -83 66 -42 22.26086957 QSE 12 95 91 71.96774194 -18 12.82608696 “Improving the quality of life” - www.aglobalhf.org

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

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.

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

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