Management and Quality control at Uganda Virus Research Institute and E-MABS
A happy child, happy mother, a developing Nation and that success clinical research
Organogram of a UVRI institute
Collaborating programmes
MRC/UVRI- Research Unit on Aids (MRC=Medical Research Council)
MRC/Wellcome trust Projects
IAVI (international AIDS Vaccine Initiative)
RHSP (Rakai Health Science Programme)
CDC (Centers for Disease Control and Prevention)
EPI/WHO (Expanded Programme on Immunization)
Ministry of Health Entebbe Hospitals (Grade A and B)
Organogram of E-MABS Research Project
Entebbe Mother And Baby Project
Quality Control
Is a system or procedures for monitoring the work processes, detecting problems and making collections prior to delivery of results.
This eliminates mistakes in clinical laboratory organization and the real goal of QC is error-free performance.
Types of errors commonly incurd in research work
Systematic errors
These are preventable for example they include;
Deterioration of Reagents and Test kits. (Due to Expiry)
Change in Reagent use. (Due to contaminations and Bad storage)
Change in Temperature of assay environment.
Drop out of study mothers from the project flow up.(Loss of their contacts)
Random errors
These are unpredictable for example;
Unstable assay environment temperatures.
Unstable power supplies.
Deaths
There two procedures of observing Quality control in clinical laboratory work.
Medical Staff procedure
The QC procedures for medical staff should include Showing;-
1.Purpose and limitations of the test.
2.Hours the test should be performed.
3.Test turn around times (expected time of sample expiry)
4.Types and quantity of specimen required
5. Specimen transport and holding instructions
Types of Quality controls to be meant;
A) Quality control of Tissue and Blood sample collection and documentation.
B) Quality control in Specimen Transport and validity setting.
C) Quality control in Handling illnesses.
Laboratory operator procedures.
The procedure manual used in the laboratory should be complete enough in detail, so that an inexperienced Technologist or Technician can perform the procedure without additional information. One copy of the manual should be readily available to bench personnel. Another copy should be stored separately in case of accidents.
D) Quality control of Reagents and Test Kits.
E) Quality control of Instruments and equipments.
F) Quality control of Tissue Cultures and Media
Quality control in clinical research laboratories
Laboratory user Quality assurance(control)
1. Laboratory personnel must have specific training in handling pathogenic agents.
2. Clinical laboratory professionals maintain strict confidentiality of patient information and test results.
3. They safeguard the dignity and privacy of patients and provide accurate information to other health care professionals about the services they provide.
4. Ensure extreme precautions with contaminated sharp items and laboratory generated wastes.
Quality control in handling and management of specimens
The reliability and accuracy of all laboratory test samples and results must be of a high integrity.
What is sample integrity?
A sample properly;
Collected
Labelled
Stored
Packaged
Transported to the laboratory
And properly processed and documented.
All these instructions when properly followed they ensure specimen integrity and accurate results.
How can QC failures be solved?
Rerun Subject samples (specimens).
Perform proper venipuncture guide lines to collect a valid sample.
Properly Document the samples .
Retest QC techniques.
Apply proper transport conditions.
Preserve time to process the sample as quickly as they are received in the laboratory.
But the major procedure for monitoring the Analytical performance of lab methods is however through statistical process control or statistical quality control.
for example cryogenic storage temperature charts.
How can QC failures be solved?
Quality control of Analytical techniques
Systematically evaluate Analytical assays. For example HIV Rapid Tests are evaluated with In-house and External quality control measures for example using Enzyme immuno assays (EIA) and Western blots.
Use Test controls in all the assays that you performed to give a clear cut line of which result racking should be taken.
Optimise your assays before proceeding. For Example an ELISA assay carried out under inappropriate Temperature will show wrong Results.
Trouble shoot your work to minimize on the sample and sampling kits wastage.
Help other researchers reach their aimed goal they will help you in another kind. (Do not be that mosquito which sucks people success)
Thank You
Acknowledgement
thank you for the endervors