Licensed cord blood bank Cordlife Group Limited (CGL) has been found to have damaged the cord blood units (CBU) of more than 2,150 clients.
The Ministry of Health (MOH) announced the news on 30 November, giving the company two weeks to make an official statement to the ministry.
The damaged CBUs have rendered them unsuitable for stem cell transplant purposes.
Here’s what the hoo-ha is about.
Audits Conducted by MOH
MOH said that on 24 July 2023, the ministry received a complaint from a member of the public.
The person alleged that CBUs stored in a tank at CGL had been exposed to temperatures above 0 degrees Celsius, among other service quality issues.
If you didn’t know, CBUs will start to thaw if exposed to temperatures above minus 150 degrees Celsius.
This results in the stem cells becoming damaged.
Thus, MOH conducted surprise audits on the company on 15 August.
They audited the company again from 16 to 21 November.
Between the first and second audits, inspectors from the ministry contacted CGL multiple times to request and clarify their reports and documents.
The inspectors also asked for further explanations in areas of discrepancies.
The audits uncovered something sus.
Following investigations, it was discovered that cryopreserved CBUs in seven of 22 CBU storage tanks had been exposed to temperatures above acceptable limits.
Furthermore, this discrepancy has been occurring since November 2020.
One of the tanks had an estimated 2,200 CBUs belonging to around 2,150 clients and was exposed to unacceptable temperatures for several days in February, March, and June 2022.
According to MOH, the company had tested some of the donated CBUs in the tank to establish the cell viability of the affected CBUs.
The ministry appointed a panel of three cord blood banking experts to review CGL’s test results independently.
They concluded that the CBUs in the tank had been damaged and were unlikely to be suitable for stem cell transplants.
MOH added that investigations are ongoing for the remaining six storage tanks.
The storage tanks contain around 17,300 CBUs belonging to approximately 17,050 clients, which is a lot of people.
MOH will be consulting its experts to check if similar tests should be performed on the other tanks.
In the meantime, the company has been ordered to stop collecting, testing, processing and storing new cord blood and human tissues for the next six months.
The company has also been banned from providing new types of tests to patients.
What are Cord Blood Units?
If you’re unfamiliar with medical terminology, here’s what you need to know about CBUs.
Cord blood refers to umbilical cord blood.
You know, the thing that connects developing fetuses to the placenta?
Notably, it is rich in blood stem cells and can be used to treat certain blood cancers and disorders.
Furthermore, it can combat immune deficiencies and certain genetic disorders.
Cord blood is rich in haematopoietic (blood-forming) stem cells.
This means that the blood can differentiate into different types of blood cells.
Besides cord blood, stem cells can also be obtained from the bone marrow and peripheral blood.
However, cord blood is unique because it can adapt to alternative environments more easily than adult stem cells.
Thus, if they can afford it, parents like to keep their children’s cord blood safe for the future.
Of course, most people don’t have the equipment to keep cord blood for future use.
Additionally, do you really want to have your cord blood lying somewhere in the house?
Therefore, CBU storage is a private service that has catered to those who want to store their children’s cord blood.
It is a service that has grown in the last 20 years and is offered to parents upon childbirth.
Cord blood can be donated to a public cord blood bank and is made available to those who need it.
Other Problems Uncovered
Unfortunately for CGL, temperature-related boo-boos were not the only problems that MOH uncovered.
The ministry discovered that the company’s temperature monitoring system didn’t notify personnel when temperatures in two tanks deviated.
This occurred between February and June 2022.
In addition, preventative maintenance that was supposed to be carried out every six months was not carried out for two tanks in 2022.
In August 2023, CGL implemented a new method of cord blood processing.
However, this method was not appropriately validated according to the approved plan and protocol.
MOH added that it will consider further enforcement actions, including but not limited to imposing financial penalties or prosecution.
The company has been directed to take the appropriate action to address the lapses.
MOH said, “CGL has not taken adequate steps to expeditiously escalate, address and rectify the above issues, including the systemic problems which may have led or contributed to them.
“CGL’s lapses will be distressing to many of their clients. MOH has instructed CGL to reach out to all its clients and address their concerns.
“Individuals who are concerned should contact CGL directly to inquire about the status of their CBU and if their CBU is in the impacted lot.”
MOH will be monitoring the company closely.
When CGL was last inspected in September 2022, MOH did not find any discrepancies relating to the temperature of the tanks.
The inspection was conducted as part of a biennial routine inspection for these services.
CGL did not reveal any incidents during or after the routine inspection.
CGL was founded in 2001.
According to its website, the company is “dedicated to safeguarding the well-being of mother and child”.
It has markets in Singapore, Hong Kong, Indonesia, the Philippines, India and Malaysia.
Besides CBU storage, the company offers other diagnostics services like prenatal testing, paediatric vision screening and newborn metabolic screening.
On the evening of 30 November, the company said that the CBUs in the affected tank comprised 2.66% of all CBUs stored in the company’s Singapore facility.
While the cord blood was no longer suitable for stem cell transplant purposes, the CGL said that it would continue to store the affected units as “they may still be valuable in light of developments in the field of cell and gene therapy.
Speaking to Channel News Asia, a CGL spokesperson said the company will continue storing the affected cord blood until the clients’ child turns 21.
The spokesperson added that future storage fees for those affected will be waived.
If it is determined that the child’s cord blood cannot be used for a transplant, the company will find a suitable alternative cord blood unit for the affected client’s child.
According to Channel News Asia, CGL is contacting all its clients to make them aware of the status of their cord blood as the situation develops.
CGL group chief executive officer Tan Poh Lan mentioned that this was the only time such an incident has happened since the company began in 2001.
In a media statement, she said, “We recognise that we have fallen short of the high standards that we hold ourselves to, and we sincerely apologise to our clients and will work diligently to regain their trust.”
She added that the company will “voluntarily initiate testing of donated cord blood samples stored in all other unaffected tanks” as a “further measure of quality control”.
Investigations on Other Licensed Cord Blood Banks
MOH also conducted a targeted audit of the other three licensed cord blood banks to reassure parents.
The audit occurred from 15 to 22 November 2023 and paid attention to the quarantine, storage and distribution of CBUs.
MOH found no abnormal temperature deviations of the other three licensed cord blood banking service providers.
The providers are Cryoviva (Singapore) Laboratory Services, Stemcord and the Singapore Cord Blood Bank.
The Future of the Cord Blood Banking Services Industry
According to the “Cord Blood Banking Services Market” research report, the market for cord blood banking is expected to grow exponentially.
In 2024, the market is expected to grow at a steady rate and is projected to reach 17240 million USD by 2028.
Some of the key players include CGL, Cord Blood America and China Cord Blood Corporation.
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