MOH sets deadline for Cordlife to comply with regulations
Cordlife has not been allowed to collect, store, or process new cord blood since 30 Nov.
The Ministry of Health (MOH) has ordered SGX-listed Cordlife Group Limited to rectify potential non-compliances of regulations by 31 May 2024.
The cord bank and blood services company received a letter from the MOH last 22 January that lists its potential areas of noncompliance with regulations on general healthcare services and cord blood banking services.
Amongst reported breaches include its temperature monitoring system’s failure to send notifications of the temperature excursions in certain tanks to the company’s personnel between February and June 2022.
The company also reportedly failed to carry out its six-monthly preventive maintenance for two tanks in 2022.
Cordlife also implemented a new cord blood processing method in August 2023 that was not properly validated according to approved plan and protocol, according to MOH, based on an SGX filing by Cordlife.
Cordilife said that it will work closely with the MOH to rectify all potential non-compliances by the deadline.
On 30 November 2023, MOH ordered the company to stop the collection, testing, processing, and/or storage of any new cord blood and human tissues for a period of six months.
The company was also prohibited from provisioning any new types of tests to patients over the same period.
“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,” Cordilife said in an SGX filing.