MOH investigates Cordlife’s blood unit mishap, triggers cord banking regulation review

Following Cordlife’s mishandling of blood units, the Ministry of Health (MOH) will review cord blood banking regulations, emphasizing the need for enhanced oversight to ensure the integrity of these medical assets and maintain public trust.

Singapore’s Senior Minister of State for Health Janil Puthucheary stated on Wednesday that the Ministry of Health (MOH) will review the regulatory requirements for cord blood banking in light of the private blood bank Cordlife’s improper handling of cord blood units.

The frequency of inspections and other aspects of inspections, as well as the necessary monitoring and reporting, are among the regulatory requirements under the Healthcare Services Act (HCSA) and the Healthcare Services (Cord Blood Banking Service) Regulations.

“However, when reviewing these regulations, we must be careful not to add unnecessary costs and regulatory compliance burdens.” “We need to take a risk-based approach,” Dr Puthucheary said in parliament.

He was responding to a question from Member of Parliament Hany Soh (PAP-Marsiling-Yew Tee) about whether MOH will consider increasing the frequency of its biennial routine inspections and improving the monitoring and reporting requirements for all licensed cord blood banking service providers.

On December 8, Health Minister Ong Ye Kung acknowledged that the investigation would likely take another six weeks to complete. Cordlife responded by accepting the six-month suspension and declining the opportunity to submit written representations to MOH regarding its operations.

Concerns about the potential fallout and the impact on affected clients remain as the investigation progresses. Cordlife, a major player in the cord blood banking industry, has come under fire, with questions raised about the adequacy of regulatory oversight and the company’s commitment to ensuring the proper handling of vital medical assets.

Dr. Puthucheary emphasized that the client’s concerns extended beyond accountability and rectification. Some clients wanted to know if they could transfer their cord blood units to another provider. In response to these inquiries, MOH reached out to other storage providers willing to help, emphasizing the complexity and risks of transferring cord blood at ultra-low temperatures.

He advised clients to wait until the ongoing investigation was completed before deciding whether to transfer their cord blood units. The inherent complexities of the transfer process, as well as the significant risks involved, necessitate this prudent advice.

The Cordlife scandal has prompted the Ministry of Health to rethink regulations governing cord blood banking in Singapore. While the cord blood banking industry is subject to two-year inspections to ensure compliance with regulatory requirements under the Healthcare Services Act, the recent incident has revealed potential oversight gaps.

Dr Puthucheary clarified that scheduled inspections are a standard practice for all cord blood banks, providing a framework for assessing regulatory compliance. However, he stated that additional visits, including unannounced inspections, may be conducted if specific areas of concern or lapses are identified.

The ministry’s commitment to overseeing Cordlife’s rectification efforts emphasizes the critical importance of preserving public trust in the cord blood banking industry. The scandal serves as a stark reminder of the critical nature of the services provided by such entities, as well as the importance of robust regulatory mechanisms to protect clients’ interests.