Premises used for the preparation of components from blood and plasma have been subject to scrutiny by the Competent Authority, the Medicines and Healthcare products Regulatory Agency (MHRA), since 2005. Such facilities must comply with the principles embodied in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007.1
Notwithstanding the fact that premises used for mobile donor sessions may often be accepted, from necessity, as the only local venue available, they must be of sufficient size, construction and location to allow proper operation, cleaning and maintenance in accordance with accepted rules of hygiene and in compliance with the WHO Expert Committee on Biological Standardization 43rd Report.2
The designated person in charge of the blood collection team should in all cases be provided
with a written plan of action appropriate to each venue. This can be used if conditions on arrival are not found to be acceptable. Care must be taken to avoid disturbances of any other activities within the venue if it is being shared.
4.1.1: Selecting a venue
Whole blood and donor component procedures for the collection of plasma, platelets, red cells or combinations of these may be carried out at fixed or mobile collection sites.
Leucapheresis procedures to collect, for example, granulocytes, lymphocytes or peripheral blood progenitor cells, should only be performed at fixed component units.
In any apheresis unit, or at any blood donor session, a telephone must be immediately available so that the emergency services can be called at any time.
Resuscitation equipment, as required by local and national guidelines for blood donor sessions, must be available at all sessions undertaking routine component procedures.
Account must be taken of the following activities/requirements when selecting a venue:
- registration of donors and all other necessary data processing
- appropriate facilities to assess the fitness of individuals to donate
- withdrawal of blood from donors without risk of contamination or errors
- social and medical care of donors, including those who suffer reactions
- sufficient seating should be provided for donors and staff, with allowance made for possible queues during busy periods
- storage of equipment, reagents and disposables
- storage during the session of blood and components, if they are not to be transferred immediately to the blood processing centre or to appropriate storage in the team vehicle
- access to an adequate electrical supply to support all electrical equipment used for the session
- the space required for these activities will depend on the anticipated workload
- flooring should be non-slip.
4.1.2: Health and safety factors
The requirements of the Health and Safety at Work Act 19743 must be taken into account when selecting sessional venues. Each organisation has the responsibility to ensure that venues comply with the Health and Safety at Work Act and that staff are fully aware of their responsibilities under this legislation. It is the responsibility of all staff with supervisory or line management responsibility to ensure that safe systems of work are in place at all times. All venues should be formally assessed for suitability with an appropriate plan to manage risks. Premises should be safe, clean and comfortable for donors and staff. In particular, the following points should be borne in mind:
- The venue should be as close as possible to the centre of population being served. It should be possible for the sessional vehicle(s) to park in close proximity to the access doors, to facilitate off-loading if required. The ground to be covered by staff carrying equipment shall be even and well lit. The space to be used should preferably not entail carriage of equipment on stairs. A similar safe approach should be ensured for donors, with as much provision as possible for car parking. Notices should be displayed, directing donors to the appropriate entry point of the building, and to the room being used.
- Furniture and equipment within the available space should be arranged to minimise crowding (with the increased risk of mistake or accident), enable adequate supervision and ensure a smooth and logical workflow.
- Fire exits must be unobstructed and operational. All sessional staff must be aware of the location of the fire extinguishers and exits.
- Lighting should be adequate for all the required activities. Provision should be made for the use of emergency lighting in the event of interruption of the electricity supply.
- Environmental control may not be within the power of a mobile team, but every effort should be made to ensure that the space does not become too hot, cold or stuffy. Subsidiary cooling fans and heating should be carried on sessional vehicles, and used as necessary. This equipment should be subjected to a planned maintenance programme.
- Facilities for the provision of refreshments for donors and staff should be separated from the other activities of a donor session whenever possible. Every effort should be made to ensure that equipment used in this area poses the minimum threat of danger to all persons.
- Toilet facilities for male and female donors and staff should be provided.
- Separate washing facilities are desirable for those staff involved in ‘clean’ procedures.
- Adequate facilities must be available for the disposal of waste. On mobile sessions, all waste should be collected and contained in a suitable manner for subsequent disposal in accordance with relevant regulations.