Cordlife to resume cord-blood banking service ‘in controlled manner’ from Sep 15
The Ministry of Health bars it from collecting, processing or storing more than 30 units of new cord blood each month between Sep 15 and Jan 13, 2025
EMBATTLED cord-blood bank Cordlife will be allowed to resume cord-blood banking services “in a controlled manner” from Sep 15, the Ministry of Health (MOH) said on Thursday (Aug 29).
However, to safeguard the interest of its customers, it will not be allowed to collect, test, process and/or store more than 30 units of new cord blood each month, from Sep 15 to Jan 13, 2025, said the ministry.
MOH’s notice on Thursday is pending Cordlife’s written representations. In a Friday announcement, Cordlife said it is seeking advice on the appropriate response to MOH’s notice.
To recap, the cord-blood bank was told to stop the collection, testing, processing and/or storage of new cord blood for a period of six months from Dec 15, 2023. This followed MOH’s announcement comes that seven of the 22 tanks at Cordlife had been exposed to temperatures above acceptable limits at different periods from November 2020.
After six months, the suspension was extended by an additional three months on Jun 15 for Cordlife to complete the validation of its new cord-blood processing method.
Follow-up audits by MOH showed that Cordlife had met the essential requirements to resume its provision of cord-blood banking services, said the ministry in its statement on Thursday.
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“For example, Cordlife has validated its new cord-blood processing method, implemented a new temperature monitoring system with acceptable temperature monitoring practices, and streamlined its incident tracking and escalation workflow,” added MOH.
In response to queries from The Business Times, Cordlife said it has complied with MOH’s regulations under the Healthcare Services Act.
These requirements include improving its quality management system, which monitors the overall effectiveness of processes; equipping the cord-blood banking facility with new lab-monitoring technology; and establishing detailed contingency plans to ensure uninterrupted service for its cord-blood storage.
The ministry has asked Cordlife to adopt “a carefully calibrated approach to gradually ramp up the provision of its services” to ensure customer welfare. MOH also noted that Cordlife has undergone “significant changes” in its governance, manpower and processes.
On Friday, the company said its inability to resume its full operations in view of MOH’s notice is expected to “continue to have a negative financial impact” on its fiscal year ending Dec 31.
The ministry will continue to monitor Cordlife’s operational stability, staff capabilities and continued compliance with regulatory requirements, up to its next licence renewal on Jan 13, 2025.
Shares of Cordlife ended Thursday at S$0.122, up 0.8 per cent or S$0.001.
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