Monitoring COVID-19 Sample Testing to Prevent Future Lapses
Ministry of HealthSpeakers
Summary
This question concerns Miss Cheng Li Hui’s inquiry regarding laboratory auditing and reported lapses in COVID-19 sample testing. Minister Gan Kim Yong explained that the Private Hospitals and Medical Clinics Act mandates quality management systems, including Ministry of Health reviews of procedures and parallel testing with the National Public Health Laboratory. As of 26 October 2020, 11 isolated incidents were reported from 3.68 million tests, leading the Ministry of Health to require root cause analyses and corrective actions from involved laboratories. Additional quality assurance measures now include process reviews when results do not corroborate clinical findings to exclude potential laboratory errors. The Ministry of Health continues to strengthen the framework through expert advice, system integration, and automation to enhance overall performance.
Transcript
16 Miss Cheng Li Hui asked the Minister for Health regarding the lapses in COVID-19 sample testing (a) whether the Ministry audits the standard operating procedures of the laboratories in order to prevent future lapses; (b) to date, how many incidents have been reported to the Ministry; and (c) how does the Ministry intend to further strengthen the COVID-19 testing framework.
Mr Gan Kim Yong: The Private Hospitals and Medical Clinics (PHMC) Act requires all clinical laboratory licensees to put in place an effective quality management system. MOH reviews the laboratories' Standard Operating Procedures (SOPs) and quality measures among other requirements, including participation in external quality assessments for every type of test performed, and licensees are required to address any gaps in process controls prior to being licensed. Clinical laboratories approved for COVID-19 polymerase chain reaction (PCR) testing are also required to perform satisfactorily in a parallel testing with National Public Health Laboratory (NPHL), with appropriate improvement measures implemented prior to scaling.
To date, there were 11 incidents reported to the Ministry for further investigations, out of a total of 3.68 million tests performed as of 26 Oct 2020. Three incidents relate to self-reported apparatus and equipment issues with no impact to the test results; three relate to improper specimen handling causing backlog or delay of test results; and five relate to quality control and reporting lapses causing test result errors. MOH was able to take quick actions to address any public health issues arising from these cases. MOH treats all incidents seriously and our investigations assessed them to be isolated events and did not result from any systemic laboratory issues.
When incidents occur in a clinical laboratory, MOH also requires the laboratory to review all its processes to identify the root cause and take appropriate corrective and preventive actions to address the laboratory error identified. The adequacy and appropriateness of the laboratory’s review and actions taken are also assessed by MOH.
For COVID-19 testing, additional quality assurance measures were introduced where a process review would be initiated to exclude any laboratory lapses when the laboratory’s result does not corroborate with clinical findings. In such instances, MOH will also provide expert advice to improve processes where needed. There are ongoing efforts to continually monitor the laboratory’s performance, and to engage the laboratories collaboratively to enhance the overall performance through further system integration and automation.