Inspections of Licensed Cord Blood Banks and Support for Customers Affected by Recent Lapse at Commercial Cord Blood Bank
Ministry of HealthSpeakers
Summary
This question concerns the regulatory oversight of licensed cord blood banks and support for customers affected by service lapses at a commercial provider. Ms Hany Soh proposed increasing the frequency of biennial routine inspections and enhancing monitoring requirements following an incident involving damaged cord blood units. Senior Minister of State for Health Dr Janil Puthucheary replied that the Ministry of Health is reviewing current regulations and inspection frequencies while balancing compliance costs through a risk-based approach. He stated that the ministry is supervising the rectification of Cordlife’s shortcomings and has engaged other storage providers to assist clients. Finally, he advised clients to await investigation results before transferring units, as moving cord blood at ultra-low temperatures involves significant technical risks.
Transcript
6 Ms Hany Soh asked the Minister for Health whether the Ministry will consider (i) increasing the frequency of its biennial routine inspection and (ii) enhancing the monitoring and reporting requirements of all licensed cord blood banking service providers.
7 Ms Hany Soh asked the Minister for Health in view of the incident involving damaged cord blood units by a commercial cord blood banking service provider (a) whether the Ministry has received any reports or requests for assistance from affected parties; (b) whether the Ministry has been directly supporting the affected clients; and (c) if so, how.
The Senior Minister of State for Health (Dr Janil Puthucheary) (for the Minister for Health): Mr Speaker, Sir, may I have your permission to answer Question Nos 6 and 7 in today's Order Paper.
Mr Speaker: Yes, you may.
Dr Janil Puthucheary: Sir, all cord blood banks in Singapore are currently subject to scheduled inspections every two years to assess their compliance with regulatory requirements under the Healthcare Services Act (HCSA). In addition, the Ministry of Health (MOH) may conduct additional visits, including unannounced visits, if there are any specific areas of concern or suspected lapses.
Arising from the Cordlife incident, MOH will review the regulatory requirements under the HCSA and the Healthcare Services (Cord Blood Banking Service) Regulations, including frequency of inspections and other aspects of inspections as well as the monitoring and reporting requirements. 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.
Many clients of Cordlife have approached MOH for assistance. Most have wanted Cordlife to rectify their 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. We have engaged the 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 units at ultra-low temperatures is a complex task and carries risks that are not insignificant.
Mr Speaker: Ms Soh.
Ms Hany Soh (Marsiling-Yew Tee): I thank the Senior Minister of State for his response. I have one clarification. I understand that inspections are carried out every two years. Is there a rationale behind why is it two years? In view of this Cordlife incident, can we also explore to see if there are any possibilities of having it on an annual basis instead, to prevent the recurrence of this unfortunate incident?
Dr Janil Puthucheary: Sir, I thank Ms Soh for the supplementary question. We are reviewing the regulatory requirements and so, one of the things that we will be reviewing is the frequency as well as the type of inspections, audits and review.