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Regulations, Guidelines and Circulars

13 May 2019

11 Apr 2019

MH 50:13\11-13

In response to the publication of the Screening Test Review Committee (STRC) Guidelines 2019, the Ministry had informed all registered medical practitioners on 6 March 2019 of the changes to population level screening, including the use of HbA1c as an alternative initial screening test for diabetes mellitus. Please see MOH Circular No 08/2019 for reference.

2. Providers who intend to offer HbA1c as an alternative testing for diabetes mellitus would need to meet the following licensing conditions on the conduct of HbA1c test under section 6(5) of the Private Hospitals and Medical Clinics (PHMC) Act:

(a) The conduct of HbA1c test shall be performed on a method certified by National Glycohemoglobin Standardisation Programme (“NGSP”)1 ; and

(b) The licensees shall participate in the External Quality Assurance Programme (EQAP) administered by Chemical Metrology Laboratory, Health Sciences Authority (“CML/HSA”).

3. We note that not all licensees may be familiar with the above requirements. Hence, to allow licensees adequate time to make the necessary arrangements for compliance, the above conditions shall be implemented in a phased approach as follows:

Phase 1: From now until the rollout of the Phase 1 of the Healthcare Services Act (HCSA) sometime in 2nd half of 2020, MOH will continue to inspect licensed healthcare institutions that provide HbA1c as an alternative screening test for diabetes mellitus and assess its compliance to the conditions detailed in para 2 above. However, we will not be taking any regulatory actions against those that are still working towards meeting the requirements.

Phase 2: The conditions in Para 2 will take effect with the rollout of Phase 1 of HCSA in 2nd half of 2020. Licensed healthcare institutions that do not meet the conditions will not be allowed to offer HbA1c as an alternative initial testing for diabetes mellitus.

4. The Ministry noted that majority of licensees performing HbA1c test had participated and performed satisfactorily in the EQAP in September 2018. If you have not participated in the EQAP above-mentioned, you may contact CML/HSA at <HSA_CMLEQA1@hsa.gov.sg> for enrolment. 

5. If you require any clarifications on the circular, please contact


ADJ ASSOC PROF (DR) RAYMOND CHUA
GROUP DIRECTOR, HEALTH REGULATION GROUP /
DIRECTOR (COVERING), REGULATORY COMPLIANCE AND ENFORCEMENT DIVISION
for DIRECTOR OF MEDICAL SERVICES



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