6.0 Resource Requirements

General

We aim to ensure there is a working environment in which staff can perform required functions in accordance with national legislation and guidelines. The premises are a state-of-the-art buildings which meets all current regulations for medical laboratory accommodation.

The premises have space for:

• Specimen reception
• The functioning and use of all equipment
• Separation of incompatible activities (e.g. Office and laboratory)
• Storage facilities

Access to the premises is by swipe card entry via locked doors. The facilities and environmental conditions are suitable for laboratory activities and do not adversely affect the validity of results, or the safety of staff/patient, laboratory visitors or any other personnel.  The laboratory facilities and environmental conditions are appropriate for the laboratory activities.  These are monitored monthly and quarterly as part of audit schedule and recorded in Q-Pulse.  Laboratory temperature is continuously monitored by enVigil-FMS Temperature Monitoring & Alarm System. This ensure laboratory premises are temperature monitored and regulated.

Facility Controls

Laboratory buildings have temperature and air management systems in place. Quarterly workplace inspections are carried out and discrepancies reported to facilities and estates department.  Building facilities are managed by facilities team with all maintenance carried out by local estates teams.

The Department provides containment level 3 (CL3) accommodation for processing high risk samples and ACDP Hazard Group 3 organisms. Protocols for regular cleaning and disinfection are described in the Department’s Health & Safety Manual.  All laboratory activities are carried out using appropriate PPE and laboratory equipment to minimise risk and potential cross-contamination.

Laboratory management’s safety responsibilities are defined in the Health & Safety Management Manual and in the Division's H&S Policy.  A hard copy of this manual is kept in the each of the OM’s office.  Laboratory safety equipment (lone worker and man down alarm) are regularly checked and serviced annually.

The Department maintains the security of its premises following Safety and Security procedures. The Head of Technical Services has overall responsibility for laboratory security. The Department restricts access to general laboratory work areas to laboratory personnel and authorised visitors. Access to the Containment level 3 laboratory is restricted as per departmental policy. Visitors to the Department are dealt with following Safety and Security procedures described in the Department’s Health & Safety manual.

Storage facilities

Paper-light systems operate with regards to reports and storage of paper records. Scanning options are available. Consumables, reagent, and patient specimen storage is appropriate with large functional areas (cold and ambient). Retention of clinical material is detailed in MP512.

GGC waste protocols H&SP506 also in place for disposal of biological waste in accordance with regulatory requirements.

Personnel facilities

Common room refectory, with a cooking, eating and drinking facility provided. Toilets, including disabled, as well as shower facilities are substantial and adequate.

Sample collection facilities

(N/A) See MP506 and MP507 Department User Manuals and GGC Microbiology website

General

We aim to ensure that sufficient & appropriate equipment is available so that service quality is at the highest level. A commitment to this effect is included in the quality manual. This includes rules for equipment procurement.

Reagents and Material and to Procurement and Management of Equipment MP514. The documents include detail of the following to ensure proper functioning to prevent contamination and deterioration:

• Selection and Procurement
• Installation
• Acceptance Procedure
• Introduction of Equipment
• Transport
• Storage
• Use
• Maintenance
• Decommissioning of equipment

Equipment requirements

See MP514 Procurement and Management of Equipment

All laboratory equipment will be used for the correct performance of laboratory activities. Appropriate laboratory equipment will be uniquely identified and maintained with corresponding record help in Q-Pulse.

Equipment acceptance procedure

See MP514 Procurement and management

All the equipment available in the laboratory must fulfil set acceptability criteria/verification/validation testing prior to use. Equipment must also undergo re-verification testing prior to return to service.

See MP514 Procurement and management

Equipment instructions for use

All staff are trained to operate all items of equipment that they may be expected to use during the course of their duties and the trainee’s competence and ability to use the equipment recorded in their training records. This is achieved by the Technical Manager observing the trainee performing certain tasks using equipment they have received training on and being satisfied that all parts of the training procedure have been covered and that the trainee has understood them. The training programme is coordinated by the Training Manager. Laboratory personnel follow standardised operating procedures for all laboratory equipment to prevent unintended adjustments or use of invalidated methods that could invalidate results.

Equipment maintenance and repair

See MP514 Procurement and management

Laboratory equipment will undergo preventive maintenance as directed by manufacturer or supplier. Any equipment that is not operational will be taken out of use and marked as out of service. Laboratory equipment that require service, or has been decommissioned, will undergo appropriate decontamination procedures.

Equipment adverse incident reporting

Equipment incidents that affect service delivery or patient care will be investigated and reported accordingly.  Any supplier recall or safety notice would also be actioned/raised in Q-Pulse.

Equipment records

See MP514 Procurement and management

Laboratory equipment records are held electronically in Q-Pulse system and include:

• Manufacturer and supplier details
• Unique identification number
• Equipment location and date of use
• Manufactures/supplier instructions
• Maintenance schedule and calibration/service documentation
• Equipment status (in-use, on-hold, decommissioned etc)

General

The Department ensures that reference standards of measurement, reference materials, measuring equipment and test equipment are calibrated and labelled accordingly. The Department maintains an inventory of equipment to be calibrated on an annual basis or other specified period.

In terms of control microorganisms used in the laboratory; only reference cultures of known provenance such as NCTC/ATCC organisms and Lenticule discs acquired from source material (UKHSA) are used.

Equipment calibration

GGC Wide Microbiology policy and procedures for the calibration of equipment is defined in MP514

Metrological traceability of measurement results

The laboratory has a policy of using annually calibrated measuring devices (MP514): thermometers, weighing device, automatic pipettes. These are calibrated to International System of Units (SI). All laboratory microscopes and pipettes are also calibrated annually. Equipment such as pipettes that are used in the Environmental Testing Laboratory are used exclusively for that purpose. For qualitative methods, traceability may be demonstrated by testing of known material or previous samples to show consistent identification/results.

General

Laboratory management ensures the availability of the reagents, calibration material and quality control material required to provide a service which meets the needs and requirements of users. Procedures are established for the management of reagents, calibration material and quality control material, refer to QP520 QC of Media, Reagents and Material.

Reagents and consumables – Receipt and storage

Laboratory reagents and consumables are stored in accordance with manufactures specification in a temperature controlled storage area.

See QP520 Management and QC of Media, Reagents & Consumables

Control of Substances Hazardous to Health files (Risk Assessment and COSHH sheets) are maintained for all hazardous materials, and manufacturers’ safety data sheets (MSDS) are held where available. Materials in use are correctly identified with date of receipt, lot numbers and expiry. Equipment management procedures are described in MP514 & held within the RMS system.

Reagents and consumables – Acceptance testing

Laboratory pre-acceptance testing is performed as stated in QP520 Management and QC of Media, Reagents & Consumables.

Reagents and consumables – Inventory management

Inventory management within the laboratory is controlled by reagent management system (RMS) and through Pecos system. These are controlled by site specific stock teams with designated quarantine areas.

Reagents and consumables – Instructions for use

Instructions and product inserts for reagents and consumables are held within Q-Pulse and are readily available to laboratory personnel.

Reagents and consumables – Adverse incident reporting

Any reagent/consumable incident will be investigated and a corresponding NC/supplier notice raised in Q-Pulse. These will be reported to service manager, or supplier, when required.

Reagents and consumables – Records

Laboratory reagents and consumable records are held in laboratory RMS and with stock teams. Where the laboratory reagents are prepared or re-suspended in-house, the records should also include the person undertaking the preparation, as well as the dates of preparation and expiry.

Agreements with laboratory users

MP503 - Establishing a Service Level Agreement details the method for this and the review process. Also, new GGC SLA template created for future service agreements within GGC.

MP517 – Review of requests, tenders and contracts details the procedure of contract review for the Environmental testing Service. It ensures that:

1. The requirements are defined
2. The laboratory has the capability and resource requirements
3. Appropriate methods are selected and meet the customers/user requirement

Agreements with POCT operators

N/A

We aim to continually improve the quality of our service by carefully selecting suppliers, and by regularly reviewing their performance. Consideration is taken of:

• Quality of service
• Professionalism
• Costs
• Contractual obligation
• Recent performance
• Availability of stock
• Time to delivery
• Partnership

Refer to Managed Service Contract and MP514 - Procurement & Management of Equipment. The laboratory ensures that only suitable externally provided products and services that affect the laboratory activities are used. The laboratory evaluates and reviews suppliers. Refer to QP520 - Management & QC of Media, Reagents & Materials for more detail

Products and services used will be:

• Incorporated into laboratory processes and used/reported as received
• Used to support the service delivery and operation of the laboratory

Referral laboratories and consultants

We aim to carefully select which referral centres and externally provided products we use, for the benefit of our users. This will ensure that the quality of our service is not compromised. This process is described in QP518 Review of Referral Laboratories and QP522 EQA Participation.

Review and approval of externally provided products and services

See:

QP518 Review of Referral laboratories

LP541 Referral of Samples

QP522 EQA Participation