Cord blood laboratories operating in the UK must comply with government licensing requirements administered by a national agency called the Human Tissue Authority. The HTA maintains on-line records of HTA licensed establishments (updated every few months) and HTA inspection reports for licensed establishments. To help clarify their cord blood regulations, on 29 Nov. 2010 the HTA issued a Guidance document for establishments working with umbilical cord blood (30 page pdf).
The development of the HTA regulations goes back at least a decade to the year 2000. In the US, human "blood" and "tissue" are regulated differently, whereas in the UK and the rest of Europe they are subject to uniform regulations. Tissue banks in the UK are regulated by the division of the UK Department of Health called the Medicines and Healthcare products Regulatory Agency (MHRA). They issued A Code of Practice for Tissue Banks (33 page pdf) in 2000, and it became compulsory after March 2004. Later in 2004, the Human Tissue Authority or HTA took over regulation of tissues intended for human transplant. The HTA licenses all UK establishments which remove, store, test, process, use or distribute any human cells that will be used to treat patients. Only tissue banks accredited by the HTA may supply tissues for therapy at National Health Service (NHS) hospitals.
The UK code of practice for tissue banks is consistent with EU standards established at the same time.On 31 March 2004 the European Parliament passed Directive 2004/23/EC (11 page pdf) titled"EU-Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells".Compliance with this directive has varied among EU nations, but the UK was one of the first to establish fully compliant regulations.
HTA regulations are intended to ensure that cord blood is collected in a way that minimises risk to the mother and child and preserves the quality of the collection. Several aspects of those regulations are:
- - The mother must give informed consent for the cord blood collection.
- - The cord blood must either be collected in a facility that is HTA-licensed, or by a person who is working under a Third Party Agreement with an HTA-licensed bank. So long as the collection specialist is properly licensed, the collection may be performed by a phlebotomist, a doctor, or a midwife.
- - However, the birthing centre is not obligated to allow a collection specialist hired by the parents to operate on their site.
- - The complexity of the regulations about who may collect cord blood, and where they may collect, has led to some confusion - even to charges of "illegal" cord blood collections by phlebotomists who had not filed the correct paperwork. In an effort to clarify the rules, the HTA has established a separate web page oncord blood procurement.
- - HTA-licensed facilites are inspected every two years. During a site visit, the HTA focuses onoperational policies and procedures, inspection of premises, review of documentation, and in some cases interviews with staff at the establishment. If the HTA inspection report identifies shortfalls, they will be classified as 'Critical', 'Major' or 'Minor'.
- - HTA facilities must be able to trace the path of a human specimen through their facility. This ensures that if there is a produblem with a human tissue product, it can be traced back to other related batches.
- - Cord blood can only be imported or exported from the UK under the authority of an HTA license or a Third Party Agreement with an HTA-licensed establishment.