MOH finds more process lapses at Cordlife, requires rectifications by end-May
THE Ministry of Health (MOH) has found more lapses at cord-blood bank Cordlife Group. These are on top of the already-announced instances when its storage tanks exceeded acceptable temperatures.
In a statement on Tuesday (Jan 23), Cordlife said MOH found three other process lapses:
A new cord-blood processing method, implemented in August 2023, was not properly validated according to approved plan and protocol;
The company’s temperature monitoring system failed to send notifications when temperatures in certain tanks exceeded acceptable levels between February and June 2022; and
Six-monthly preventative maintenance was not carried out for two tanks in 2022.
Cordlife was issued a suspension notice on Nov 30, 2023, after MOH investigations found seven of the group’s 22 cord-blood storage tanks had recorded temperatures above acceptable limits.
On Jan 22, MOH followed up with a letter listing other potential areas of non-compliance with the Healthcare Services (General) Regulations and the Healthcare Services (Cord Blood Banking Services) Regulations.
MOH highlighted the cord-blood bank’s ineffective incident reporting frameworks, inadequate training and competence of staff, and the inappropriate storage of cord-blood units.
“The company has been informed that it is required to rectify the potential non-compliances by May 31, 2024,” said Cordlife, adding that it will work closely with MOH to ensure all identified issues are rectified by the deadline.
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On Jan 17, the company updated that it would send the cord-blood samples from all affected tanks to a third-party laboratory by Jan 18. Testing of these samples, to find out whether they are still usable, might take three to six weeks.
On Jan 10, Senior Minister of State for Health Janil Puthucheary said in Parliament that MOH is reviewing the regulatory requirements for cord-blood banking providers.
Cordlife : P8A 0% had requested a trading halt at 9.45 am on Tuesday to make the announcement. The halt was lifted at 10.30 am. As at 10.45 am, the counter was trading flat at S$0.30.
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