MOH to review regulatory requirements for cord blood banking after Cordlife’s mishandling of blood units
All cord blood banks in Singapore are subject to scheduled inspections every two years, and MOH may also conduct additional visits, including those that are unannounced.
A Cordlife branch at Mount Elizabeth Novena Hospital on Dec 1, 2023. (File photo: TODAY/Ooi Boon Keong)
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SINGAPORE: Following private blood bank Cordlife’s mishandling of cord blood units, the Ministry of Health (MOH) will review the regulatory requirements for cord blood banking, said Senior Minister of State for Health Janil Puthucheary on Wednesday (Jan 10).
The regulatory requirements under the Healthcare Services Act (HCSA) and the Healthcare Services (Cord Blood Banking Service) Regulations include frequency of inspections and other aspects of inspections, as well as monitoring and reporting requisites.
“However, in reviewing these regulations, we also need to be mindful not to add inappropriate costs and regulatory compliance burden. We need to take a risk-based approach,” said Dr Puthucheary in parliament.
He was responding to questions from Member of Parliament Hany Soh (PAP-Marsiling–Yew Tee) on whether MOH will consider increasing the frequency of its biennial routine inspection and enhancing the monitoring and reporting requirements of all licensed cord blood banking service providers.
She also asked if the ministry had received any reports or requests for assistance from affected parties and whether it has directly supported the clients.
Cordlife has been in the spotlight for damaging cord blood units belonging to at least 2,150 clients, with another 17,000 clients possibly affected.
The cord blood units were stored in seven tanks that were exposed to temperatures above acceptable limits.
MOH first made the incident public in November last year when it announced that Cordlife was being investigated. The ministry had ordered Cordlife to stop the collection, testing, processing and/or storage of any new cord blood and human tissues, or provide any new types of tests to patients, for a period of up to six months.
Health Minister Ong Ye Kung said on Dec 8 that the probe into Cordlife would likely take another six weeks. Shortly after, the company announced that it would accept the six-month suspension and that it would not be submitting written representations to MOH for its operations.
The Ministry of Health (MOH) has scheduled inspections every two years for cord blood banks to assess their compliance with regulatory requirements under the Healthcare Services Act. It may conduct additional visits if there are specific areas of concern or suspected lapses. Arising from the Cordlife incident, MOH will review the regulatory requirements, including inspections, monitoring and reporting. Senior Minister of State for Health Janil Puthucheary said this in reply to an MP's questions in Parliament on Wednesday (Jan 10). He cautioned against adding inappropriate costs and regulatory compliance burden. “We need to take a risk-based approach,” he said. Dr Janil pointed out that many clients of Cordlife have approached MOH for assistance. Most of them wanted Cordlife to rectify the shortcomings and this will be MOH’s “supervision priority” as investigations are being conducted. MOH has also received enquiries about transferring cord blood units to another provider. He said MOH has engaged the other storage providers and they are prepared to assist. MOH has advised clients to wait for the investigation to be completed, likely in a few weeks’, before deciding on whether to do so. “Transferring cord blood units at ultra-low temperatures is a complex task and carries risks that are not insignificant,” he said.
CLIENTS WANT CORDLIFE TO "RECTIFY SHORTCOMINGS"
All cord blood banks in Singapore are currently subject to scheduled inspections every two years to assess their compliance with regulatory requirements under the HCSA.
MOH may also conduct additional visits, including those that may be unannounced, if there are any specific areas of concern or suspected lapses, said Dr Puthucheary.
He added that many Cordlife clients have also approached the ministry for assistance.
“Most have wanted Cordlife to rectify their shortcomings and this will be MOH’s supervision priority as investigations are being conducted.”
Dr Puthucheary added that the Health Ministry also received enquiries about transferring cord blood units to another provider, and has engaged other storage providers who are prepared to assist.
“MOH has advised that clients wait for the investigation to complete likely in a few weeks’ time before deciding whether to do so.
“Transferring cord blood at ultra-low temperatures is a complex task, and carries risks that are not insignificant.”
