TEST RESULTS OF FIVE OTHER TANKS
The remaining five tanks, which store about 14,000 cord blood units, have been assessed through investigations to be “at low risk of being adversely affected by temperature warming events”, said MOH.
All 30 samples from across the five tanks passed the viability and potency tests conducted by an independent third-party lab.
The root cause analysis indicated that the “temperature warming events” in four out of five tanks – Tanks D to G – were likely due to misplaced temperature probes during scheduled maintenance, or incorrect mapping of the temperature probe to the tank.
For Tank C, the duration of exposure to the highest temperature of -144.7 degrees Celsius might not have caused damage to the cord blood units, said MOH.
MOH experts have recommended that Cordlife test a large number of cord blood units in these five tanks to achieve more statistically significant results – 99 per cent of the samples tested must pass both potency and viability tests.
Cordlife has agreed to test more than 200 more samples across the five tanks and will review the outcome of the test results with MOH experts.
“As the tests, which involve complex processes, have to be carefully carried out, Cordlife expects to take approximately another year to complete the tests,” said the ministry.
Cordlife has also been told to inform its affected clients if their units are in the five tanks that have a low risk of being affected, but are awaiting further tests.
“Affected clients of Cordlife are advised to be patient and await these results before making any decisions, including the transfer of cord blood units to another cord blood bank, given that there are significant risks involved in the transfer of cord blood units,” said MOH.
“MOH will continue to closely supervise Cordlife’s rectification of the weaknesses identified in their governance structure, processes, systems and documentation.”
