On 22 August 2017 CellNass successfully completed a site visit inspection in compliance with Human Tissue Authority (HTA) licensing standards, being found to have met all HTA requirements.
In concluding the report, the HTA stated:
The facility is well run, and staff interviewed have an awareness of the importance of the tissue they hold and the regulatory requirements under the Human Tissue Act. There were a number of areas of good practice observed on inspection:
- The establishment’s tracking system is well managed and gives customers oversight of tissue in storage
- The recall process for samples is well managed and has a number of built-in double checks to ensure the sample returned to the customer is the one requested
- Feedback from customers and any incidents are reviewed and used for learning, often resulting in improvements in systems and processes
- Standard Operating Procedure (SOP) documents are well organised, have pictures to add clarity and a number of processes are also available as a flowchart which is easily followed
- All boxes stored in the facility have a plastic cover to protect them in the unlikely event of a sprinkler malfunction
- The tissue held for research is stored in formalin, so the establishment takes additional care when the customer requests samples, and staff themselves transport the material by car to ensure its safe arrival.
The HTA has assessed the establishment as suitable to be licensed for the activities specified.
To view the full inspection report, please follow the link below:
Who are the Human Tissue Authority?
The Human Tissue Authority (HTA) is a regulator set up in 2005 following events in the 1990s that revealed a culture in hospitals of removing and retaining human organs without consent. The legislation that established the HTA not only addressed this issue but also updated and brought together other laws that relate to human organs and tissue.
The HTA were created by Parliament as a non-departmental public body of the Department of Health, and are overseen by an Authority of lay and professional members appointment by the Government.
The HTA regulate organisations that remove, store and use human tissue for research, post-mortem examination, medical treatment, education and training. Organ and bone marrow donations from living people are also approved by the HTA.
Why do the HTA carry out inspections?
The Human Tissue Authority (HTA) regulate organisations that remove, store and use human bodies and tissues for certain purposes. Their goal is to maintain confidence that human tissue and organs are used safely and ethically with proper consent.
The HTA license over 800 organisations across six regulated sectors in the United Kingdom. Standards are set by the HTA on all aspects of practice and ensure that all their licensed establishments are operating to these standards. Every organisation must nominate a person to supervise the activities for which they are licensed, known as a Designated Individual (DI).
The HTA carry out inspections to access whether the DI is suitable to supervise the activities covered by their license. Visiting the establishment is an important part of their inspection process as it gives them the opportunity to not only talk to the DI and their staff but to view the premises and facilities, and review their policies and procedures.
After every site visit inspection, the HTA write a report documenting their findings. A HTA report sets out the good practices found, as well as any concerns they may have. Any evidence of breached regulations is also clearly set out. The HTA also make recommendations to help the organisation improve on any areas of underperformance.
What is CellNass?
CellNass is an innovative, national archive management service from Cell Path Ltd. Although CellNass was originally intended for the archiving of pathology blocks and slides, over recent years it has expanded to cover multiple disciplines with materials such as blood spot cards, transfusion records, documents, paper reports and much more. As a result, CellNass is now able to provide a complete archive management solution, ideal for hospitals – more than 50% of NHS hospitals now use CellNass – and laboratories with limited or expensive-to-run onsite storage space.
Continual investment in their facilities and technology, along with a dedicated team of professionals with expertise in Pathology and logistics, means that CellNass have an in-depth understanding of their client’s requirements and their working environment.
Benefits of using CellNass:
- Allows hospitals to release space for other uses
- Dedicated archiving environment
- Removes the time and effort required to operate an onsite archiving facility
- Enables laboratory staff to focus on their daily tasks rather than onsite archiving
- Full traceability and easy retrieval of individual items using CellNass’ unique archive management system, CellTrak
- Cost effective solution