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No mention of stem cells in release on laboratory regulations

Health Minister Nelson Bascome yesterday announced new regulations for the management of clinical laboratories — but it seems they will not cover the adult stem cell clinic being set up in Winterhaven, Smith's.

The rules, effective from next month, require all clinical labs to be registered with Chief Medical Officer John Cann as part of a Caribbean-wide initiative to monitor labs more closely.

In a Ministry of Health statement released yesterday, there was no mention of whether stem cells would be included in the new regulations. However, the Ministry has previously stated that based on its information the Brown-Darrell Clinic will not be a clinical lab — meaning it would appear to fall outside the new regulations.

Doctors in the UK and the US, where stem cell use is heavily monitored, have already aired concerns about the lack of stem cell regulations in Bermuda ahead of the opening of the Brown-Darrell Clinic, a private partnership between Premier Ewart Brown, wife Wanda and California-based Stemedica.

Yesterday's Ministry of Health statement said the new regulations are the culmination of a project called Strengthening of Medical Laboratory Services in the Caribbean, spearheaded by the Caribbean Epidemiology Centre (CAREC) and funded by the European Union.

In order to be registered, clinical lab owners and managers must satisfy Dr. Cann that they are a fit and proper person, show their buildings, staff and equipment are suitable for the purposes intended, and that the lab is accredited with one of four international accreditation agencies: College of American Pathologists; Caribbean Laboratory Accreditation Scheme; Commission on Office Laboratory Accreditation; or Joint Commission International.

Mr. Bascome said one feature of the regulations was the ability to provide provisional registration for labs that are not accredited. However, there is a two-year period for accreditation to be achieved. The Bermuda National Laboratory Advisory Committee, as required by CAREC, comprises representatives from the Department of Health, Bermuda Hospitals Board Laboratory and operators of privately owned facilities.

The advisory committee's role is to guide and facilitate the systematic implementation of lab standards in both private and public sector medical and public health laboratories.

Mr. Bascome said in a statement: "I am pleased to see this important piece of work come to a conclusion. The Government has a duty to ensure that healthcare providers and healthcare services in Bermuda meet the highest standards and that those standards have meaning beyond our shores. "This will ensure that there is a level of comfort among the community who must make use of the services that are provided."

Mr. Bascome has not replied to this newspaper's request for an interview about the Brown-Darrell Clinic.