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Covid 19 Testing

Personnel taking the samples

The personnel taking the samples of nasopharyngeal and oropharyngeal swabs must be a registered medical practitioner who has attended training and has a certificate of attendance for Sample Taking and Handling Training for COVID-19 for General Practitioners and Paramedics from Private Health Facilities issued by the Family Health Development Division, MOH or State / Federal Health Department. Sampling can only be done by the Private Healthcare Facilities and Services registered or licensed under Act 586 at the premises or elsewhere that has been approved for the facilities by the Medical Practice Division, Ministry of Health Malaysia.

Personnel conducting the tests

The personnel conducting the test procedure shall have the qualifications, training, and experience appropriate to the tasks performed. The personnel shall have a minimum Diploma in Medical Laboratory Technology with experience of performing nucleic acid testing of at least 3 months. Training and competency in nucleic acid testing methods shall also be documented.

Authorized signatory

The laboratory shall have qualified, skilled and experienced signatory (ies) to validate data and troubleshoot problems. Approved signatory (ies) shall have a degree or higher in the microbiology field, trained and competent in the nucleic acid method, with at least one year or more laboratory working experience and at least 3 months working experience in the current laboratory. For those with less than 1-year laboratory working experience shall have at least 6 months working experience in the current laboratory. Trained and competent Pathologist or Scientific Officer in Nucleic Acid Testing are also allowed to validate the result.

Accommodation and environmental conditions

The laboratory shall have dedicated areas for specimen reception, pre and post analysis to minimize cross-contamination. There shall be separate room for pre-PCR, reagent preparation and PCR amplification. The laboratory that has fully automated system, such as from extraction to master-mix preparation, need not have separate room.

Examination procedure

The laboratory shall have a standard operating procedure for conducting the real-time RT-PCR. All worksheets related to the testing shall be kept and maintained for retention of record.

Waste management

The laboratory shall have waste management procedure in place. All clinical samples and consumables used shall be autoclaved or incinerated.

Risk Management

The laboratory shall have risk assessment activities for performing SARS-CoV2 RT-PCR testing.