Cord blood units have to be stored at temperatures below minus 150 deg C, or they could thaw and be damaged. - ST
SINGAPORE: The Ministry of Health (MOH) has found more potential lapses such as ineffective incident reporting frameworks and inadequate training and competence of staff at private cord blood bank Cordlife amid investigations, and has given the company till the end of May to rectify the issues.
In a regulatory filing on Jan 23, Cordlife said it received a letter from MOH with a list of the “potential areas of non-compliance” with health regulations that the ministry has identified based on its inspections. These also include inappropriate storage of cord blood units.
“The company has been informed that it is required to rectify the potential non-compliances (including the circumstances which had led to the potential non-compliances) by May 31, 2024,” said Cordlife.
The company’s processes have come under the spotlight after the health authorities revealed on Nov 30, 2023, that seven of its 22 storage tanks were exposed to temperatures above minus 150 deg C.
Cord blood units have to be stored at temperatures below minus 150 deg C, or they could thaw and be damaged.
Around 2,200 cord blood units in one of the affected tanks were damaged and rendered unsuitable for stem cell transplants.
Investigations into the viability of cord blood units in the six other tanks are under way, with updates by MOH due soon.
Health Minister Ong Ye Kung announced on Dec 8, 2023, that investigations would take roughly six weeks.
Other process lapses previously reported on Nov 30 include:
Cordlife’s temperature monitoring system failed to send notifications of the temperature lapses in certain tanks to personnel between February and June 2022; six-monthly preventative maintenance was not carried out for two tanks in 2022; and a new cord blood processing method that was implemented in August 2023 was not properly validated according to the approved plan and protocol.
The company said in the Jan 23 filing that it will continue to work closely with MOH to ensure that all identified issues are rectified by the deadline.
“The company will also continue to comply with all other statutory requirements, including those found under the Healthcare Services Act 2020 and its subsidiary legislations, as well as the licensing conditions issued to the company in relation to its licensable healthcare services,” it added.
On Jan 10, Senior Minister of State for Health Janil Puthucheary said MOH will review regulatory requirements for cord blood banking following the Cordlife incident. - The Straits Times/ANN
