The_King Posted January 23 Share Posted January 23 SINGAPORE: The Ministry of Health (MOH) has found more lapses at Cordlife amid investigations into the private blood bank for mishandling the storage of cord blood units. Cordlife, which is listed on the Singapore Exchange (SGX), is under scrutiny after it was revealed that several storage tanks were exposed to temperatures above -150 degrees Celsius, the acceptable limit for cord blood units. The was made public on Nov 30 when the ministry said Cordlife was being investigated. Around 2,200 cord blood units stored in one of the seven affected tanks were damaged. 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. These include ineffective incident reporting frameworks, inadequate training and competence of staff, and the inappropriate storage of cord blood units, among others, said Cordlife. On top of the previously announced temperature issues in the tanks, the ministry said on Nov 30 that it 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 the 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. The company said in Tuesday’s filing that 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. Cordlife said in December that it would accept a six-month suspension given by the ministry. 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. Source: CNA/ec(sn) 1 2 Link to comment Share on other sites More sharing options...
Huat Zai Posted January 23 Share Posted January 23 4 hours ago, The_King said: SINGAPORE: The Ministry of Health (MOH) has found more lapses at Cordlife amid investigations into the private blood bank for mishandling the storage of cord blood units. Cordlife, which is listed on the Singapore Exchange (SGX), is under scrutiny after it was revealed that several storage tanks were exposed to temperatures above -150 degrees Celsius, the acceptable limit for cord blood units. The was made public on Nov 30 when the ministry said Cordlife was being investigated. Around 2,200 cord blood units stored in one of the seven affected tanks were damaged. 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. These include ineffective incident reporting frameworks, inadequate training and competence of staff, and the inappropriate storage of cord blood units, among others, said Cordlife. On top of the previously announced temperature issues in the tanks, the ministry said on Nov 30 that it 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 the 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. The company said in Tuesday’s filing that 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. Cordlife said in December that it would accept a six-month suspension given by the ministry. 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. Source: CNA/ec(sn) Knn, charge so much and can't even do their basic job properly. 2 Official Mugentech Minecraft server: Please see thread in Gamers Link to comment Share on other sites More sharing options...
XianGe Posted January 24 Share Posted January 24 8 hours ago, Huat Zai said: Knn, charge so much and can't even do their basic job properly. Maybe went cheaper faster better 2 Link to comment Share on other sites More sharing options...
ManOfTheHour Posted January 25 Share Posted January 25 On 1/24/2024 at 2:28 AM, Huat Zai said: Knn, charge so much and can't even do their basic job properly. They always get prime spot at baby fairs too 1 Link to comment Share on other sites More sharing options...
ODACHEK Posted January 25 Share Posted January 25 Cannotch rectify rah....spoiled means spoiled... 4 TVB for life... Link to comment Share on other sites More sharing options...
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