SINGAPORE — The Ministry of Health (MOH) has found more lapses at Cordlife amid ongoing investigations into the private blood bank.
Cordlife, which is listed on the Singapore Exchange (SGX), said in December it would accept a six-month suspension given by MOH over the exposure of several cord blood tanks to irregular temperatures.
The ministry first made public on Nov 30 that Cordlife was being investigated. The affected storage tanks were found to have been exposed to temperatures above —150°C, the acceptable limit for cord blood units.
Around 2,200 cord blood units — stored in one of the seven affected tanks — belonging to approximately 2,150 clients have been damaged. Another 17,000 clients could be affected, pending investigations into the other six tanks. Health Minister Ong Ye Kung said on Dec 8 that the probe “should take another six weeks or so”.
In a regulatory filing on Tuesday (Jan 23), Cordlife said it received a letter from MOH providing a list of the “potential areas of non-compliance” with health regulations that the ministry has identified based on its inspections.
The “potential areas of non-compliance” MOH cited in its letter include ineffective incident reporting frameworks, inadequate training and competence of staff, and the inappropriate storage of cord blood units, among others, said the private blood bank.
On top of the previously announced temperature excursions in the tanks, Cordlife added that the ministry has found three other process lapses:
- Its temperature monitoring system failed to send notifications of the temperature excursions in certain tanks to company personnel between February and June 2022.
- The six-monthly preventative maintenance was not carried out for two tanks in 2022.
- A new cord blood processing method that was implemented in August 2023 was not properly validated according to approved plan and protocol.
“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.
Cordlife said in Tuesday’s filing it will continue to “work closely” with MOH to ensure that all identified issues are rectified by the May 31 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.
TESTING UNDERWAY AT THIRD-PARTY LABORATORY
In a separate regulatory filing on Jan 17, Cordlife gave an update on the probe, saying it has started sending donated cord blood samples from the affected tanks under investigation to a third-party laboratory in Singapore licensed by MOH for testing in batches.
It added that donated cord blood samples from five tanks had been sent and the company aimed to complete the sending of samples from all the affected tanks by Jan 18.
Cordlife said the testing of each batch might take between three and six weeks to be completed, depending on whether there is a need to conduct repeat testing of samples from the same tank, and that samples from the remaining unaffected tanks will also undergo testing in “due course”.
The company also said affected clients have been updated on this testing and they will be notified once the “relevant test results are available”.
MOH ordered Cordlife on Nov 30 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.
And in December, Cordlife’s cellular therapy accreditation was indefinitely suspended by the Foundation for the Accreditation of Cellular Therapy, a global non-profit corporation which conducts inspections and accreditation in cellular therapy.
Earlier this month, Senior Minister of State for Health Janil Puthucheary said MOH will review the regulatory requirements for cord blood banking, following Cordlife’s mishandling of cord blood units. CNA