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Quality Assurance, and Compliance

Quality Assurance, and Compliance

The NHLQATC is accredited under IEC/ISO 15189:2012 Medical laboratories requirements for quality and competence by SADCAS in 2014 with certificate number MED 001. Laboratory Results produced at NHLQATC are accurate and reliable hence facilitates proper investigation and diagnosis of diseases or outbreaks for treatment and management of patients. This was made possible due to effective implementation of our laboratory policies, processes and procedures in Pre examination, examination and post examination activities.

(1) Pre Examination Activities.

Sample Collection, Transportation, Reception and Processing.
NHLQATC ensures that, proper, correct and quality samples are collected, transported and received for testing. Our customers are oriented on and provided with a copy of sample collection manual which gives guidance for sample requirements, choice of examination, transportation requirements for each specific test. We have competent staff enough to identify samples which do not meet the laboratory acceptance criteria/requirements using the established sample management procedure.Samples that meet acceptance criteria are registered and assigned aunique identification numbers and sent to the section for testing.
However samples that do not meet acceptance criteria are also registered and assigned with unique numbers but not sent to the section for testing. Customers with these samples are informed on the failure status of their samples against acceptance criteria and instructed on the appropriate steps to take to ensure laboratory service is delivered to the customer as necessary.

(2) Examination Activities.

(a) Equipment, Testing Methods and Personnel Competency
Received samples in the laboratory are tested as per our established technical procedures. We use calibrated equipment which are scheduled for planned preventive maintenance by using a procedure “Selection, Purchasing and Equipment management”to ensure our equipment are continuously performing well. Our testing methods are validated/verified to confirm the claimed manufacturer performance criteria before we put them into use under the guidance of a “Method validation and Verification procedure”. Staff assigned to perform examination procedures have demonstrated necessary skills and experience, trained on specific tasks and have been assessed and deemed competent to perform the tasks,under the guidance of a “Personnel Management Procedure” to ensure only accurate and reliable results are released to requester.

(b) Internal Quality Controls.
At NHLQATC, we ensure that every test passes the Internal Quality Control (IQC) procedure before any patient sample is tested and results released. The IQC procedures enable us to identify presence of systematic and random errors that might be due to equipment, reagents and human errors respectively. Presence of these errors may invalidate the accuracy and reliability of examination results. Technical procedures specific to each discipline are available to ensure effective detection of systematic and random errors. Qualitative and quantitative results from the IQC run are viewed against our pre established criteria to assess whether the IQC results are acceptable (pass) or unacceptable (failed) and we take appropriate actions against unacceptable results as per our “Reviewing of QC Results Procedure”.

(c) Proficiency Testing-PT.
Our laboratory is registered to various competent (IEC/ISO 17043 accredited) organizations/institutions which provide proficiency testing materials (PT/EQA) to compare our testing processes with other medical laboratories worldwide.

Some of these organisations/institutions are:
i.   Randox Laboratories ltd-UK (providing Clinical Chemistry, Haematology and Serology PT panels),
ii.  National Health Laboratory Service (NHLS)-South Africa (providing Early Infants Diagnosis -EID PT panels),
iii. CDC Atlanta (providing viral load PT panels),
iv. WHO Influenza EQAP-Virology Division Centre for Health Protection, Public Health Laboratory Centre-Hong Kong SAR (providing Influenza panels),
v.  WHO Canada (providing microbiology and QASI CD4) etc.
NHLQATC results that are sent to PT providers are analysed according to set criteria, and compared within a peer group. Errors which could not be captured by our Internal Quality Control procedures, can be detected through results from PT provider.. We take appropriate corrective actions against any identified errors to ensure accurate and reliable results are delivered to customers.

(3) Post examination activities.

Legible and clear results in English language are printed though our Laboratory Information System (DISA™) which has been interfaced with all equipment in the laboratory. The system has been connected with all Zonal Referral laboratories in the country. Referred results from zonal laboratories can be accessed easily using this system.

All patient results are handled with maximum confidentiality. Competent personnel reviews and authorizes results before issue to requester. We have a specific procedure to review results “Management of Results Procedure” to ensure accurate, relevant and reliable results are released to customers.