Errors in DNA Tests Conducted by the HSA (Preventive Measures)

17 January 2012

Question No. 24

Name of person: Dr Lam Pin Min

Question

To ask the Minister for Health in light of the recent errors in DNA tests conducted by the Health Sciences Authority (HSA) (a) what measures will be put in place to ensure similar incidents do not happen again; and (b) whether the Ministry will conduct a thorough review of HSA's laboratory work processes to ensure compliance with International standards and practices.

Answer

1. The Ministry of Health (MOH) takes a serious view of this incident. To summarise what happened, in August 2011, the Health Sciences Authority’s (HSA) DNA Profiling Laboratory (DNAPL) discovered that a reagent of higher than usual concentration (“the Reagent”) had been used as part of the DNA testing process from October 2010 to August 2011. The key scientific impact of the Reagent was a marginal reduction in the sensitivity of the DNA tests when low levels of DNA were being analysed. This did not cause any false positive results leading to wrongful identification of any person. Re-testing of DNA samples was initiated as a precautionary measure. For the concluded cases, the Attorney-General’s Chambers (AGC)’s assessment is that there were no wrongful convictions due to the use of the Reagent.

2. Following the discovery of the incident in August 2011, an inter-government agency group comprising the AGC, the Singapore Police Force (SPF), the Central Narcotics Bureau (CNB) and HSA was established to assess the impact of the Reagent on the DNA tests affected.

3. The scientific impact of the incident has been established to be minimal. Foreign experts have confirmed that there would have been no false positive results leading to wrongful identification of a person, and no one wrongly identified as a result of the incident. The inter-government agency group studied each and every case which may have been affected by the incident and identified cases for re-testing as a precautionary measure. The re-tests are expected to be completed in March 2012.

4. HSA has been open and transparent and has dealt with the incident in a professional, objective, and timely manner. It took prompt action in August 2011 to tighten reagent preparation by using the prior established method of weighing powdered chemicals and dissolving in water. The Laboratory now no longer prepares the particular reagent in house but instead uses a commercially-prepared reagent which only became available after the affected batch had been prepared. The same approach is also adopted for other steps in the Laboratory’s testing processes where such commercially-prepared reagents are available.

5. In addition, reagents are now also sent to HSA’s Chemical Metrology Laboratory for chemical composition analysis to verify their contents and concentration prior to use. This now goes beyond the existing internationally benchmarked quality assurance system and quality control checks.

6. The DNA Profiling Laboratory has been accredited by the American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB) since 1996. This sets the benchmark for international best practice and standards for testing. The Laboratory will be undergoing a scheduled re-accreditation audit by external assessors from the accreditation agency in February 2012. As part of its accreditation requirements, HSA highlighted the incident to the accreditation agency in November 2011.

7.The HSA Board has appointed a Committee to conduct an independent and in-depth review of the incident. The Committee will also recommend appropriate measures to strengthen HSA’s wider risk management processes to prevent recurrence of such an incident. This Committee is chaired by Ms Serene Wee, CEO of the Singapore Academy of Law, who also chairs HSA’s Audit Committee. The other two members are Professor Ranga Krishnan, HSA Board Member and Dean of the Duke-NUS Graduate Medical School, and Mr Max Loh, a Managing Partner of Ernst and Young. Together, the three members of the committee will draw in legal, scientific and accounting expertise to the review process and assessment. The Committee has already commenced its review. It will be supported by a Secretariat staffed by MOH personnel.

8. The Committee will review how the incident occurred, the investigation process and the follow up actions taken. The Committee will also review HSA’s operating procedures and existing risk management systems and processes. It will recommend whether any additional measures are required to strengthen these areas. Any weaknesses in systems identified by the Committee will be rectified immediately even while the Committee’s work is on-going. Beyond reviewing the immediate incident, the Committee will submit its findings and recommendations to the HSA Board and the Ministry of Health. MOH and HSA will update the public again when the review and the re-testing of samples requested by AGC are completed, which will be around March.