Quality manual


Accommodation and Environmental Conditions



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5.2 Accommodation and Environmental Conditions





      1. General

There is a procedure in place to describe the facilities in the laboratory



MP-GEN-0025 Facilities in the Department of Pathology. The Department of Pathology facilities are ergonomically designed to ensure that the workload can be performed without compromising the quality of work, quality control procedures, health and safety of personnel, patients and visitors. Adequate space is available for specimen collection, specimen reception, handling, despatch and Haemovigilance and traceability activities in the department.
The laboratory evaluates and determines the sufficiency and adequacy of the space allocated for the performance of the work.
5.2.2 Laboratory and Office Facilities
The design and environment of the Department of Pathology is suitable for the tasks carried out therein. The environments in which the primary sample collection and examination / testing are performed is controlled so that samples taken or results of testing performed are valid and not adversely affected in quality.
The design of the Department of Pathology permits correct performance of examinations due to the following:


  • Adequate energy sources

  • Adequate lighting

  • Adequate ventilation

  • Adequate heating

  • Adequate water supply

  • Adequate waste and refuse disposal

  • Controlled environmental conditions.

The Department of Pathology has procedures for checking that the environment does not adversely affect the performance of specimen collection and equipment. Attention is paid to overall cleanliness and temperatures relevant to the technical activities concerned. Environmental conditions are routinely monitored either manually or by the Rees temperature monitoring system. This is implemented through MP-GEN-0025 Facilities in the Department of Pathology. Environmental conditions are also assessed through regular audits.


The Department of Pathology is designed such that there is clear segregation between clerical and laboratory areas resulting in efficiency of its operation. This ensures the comfort of its occupants and minimises the risk of injury and occupational illness. This is implemented through MP-GEN-0025 Facilities in the Department of Pathology. The Department of Pathology and associated office facilities provide an environment suitable for the tasks to be undertaken by ensuring that access to and use of areas affecting the quality of examinations is controlled by means of a swipe card security system, ensuring that access to the laboratory is traceable. An electronic swipe card access security system is in place to ensure only authorised staff have access to the Department of Pathology, as described in MP-GEN-0025 Facilities in the Department of Pathology.
The laboratory also ensures that:

  1. Access to, and use of, areas affecting the quality of the examinations are controlled. Appropriate security measures are in place to safeguard samples and resources from unauthorized access.




  1. Medical information, patient samples and laboratory resources are safeguarded from unauthorised access.




  1. Facilities for examination allow for correct performance of examinations. These include energy sources, lighting, ventilation, noise, water, waste disposal and environment conditions




  1. Communication systems within the laboratory are appropriate to the size and complexity of the facility to ensure the efficient transfer of information and implemented through MP-GEN-0025 Facilities in the Department of Pathology.

These include:




  • E-mail

  • Meetings (all minuted)

  • Notice Boards/Memos

  • Message Logs

  • Handover Logs




  1. Safety facilities and devices are provided where appropriate and their functioning regularly verified.




      1. Storage Facilities

Storage space and conditions are provided that ensure the continuing integrity of sample materials, documents, equipment, reagents, consumables, records, results and any other items that could affect the quality of examination results.


This is implemented through:



    • MP-GEN-0002 Management of Documentation, Preparation and Control

    • LP-BT-0002 Monitoring of Materials in Blood Transfusion

    • LP-BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables

    • LP-HAEM-0012 Batch Acceptance of Reagents in Haematology

    • MP-GEN-0004 Management of Clinical Material

    • LP-MIC-0065 Batch Acceptance in Microbiology

Storage and disposable facilities for dangerous materials are appropriate to the hazards of the materials and as specified by applicable requirements.


Appropriate Safety signage is used where there are potential hazards. Hazardous chemicals are stored in the chemical cabinets. The fume cupboard is used to dispense hazardous materials and to minimise the risk of inhalation of vapours or particles. All hazardous chemicals are clearly labelled. MP-GEN-0007 Staff Health and Safety Manual is available for consultation by all staff.
5.2.4 Staff Facilities
There is adequate access to washrooms, to a supply of drinking water to facilitate for storage of personal protective equipment and clothing.
The laboratory provides space for staff activities such as meetings and quiet study and a rest area.
5.2.5 Patient Sample Collection Facilities
The Phlebotomy Department is located in the out patients department. The Phlebotomy facilities are designed to accommodate patients with disabilities allowing comfort and privacy, in addition to the optimization of collection conditions. Phlebotomy activities are conducted in the phlebotomy room which is segregated to ensure patient comfort and privacy. Patient facilities on the hospital wards and clinics ensure privacy, comfort and adequate space for the taking of blood samples.
Consideration is given to the accommodation of patient privacy, comfort and needs and accommodation of appropriate accompanying person (e.g. guardian or interpreter) during collection.
Facilities at which patient sample collection procedures are performed enable the sample collection to be undertaken in a manner that does not invalidate the results or adversely affect the quality of the examination.
The sample collection facility has and maintains first aid materials for both patient and staff needs.
5.2.6 Facility Maintenance and Environmental Conditions
All work areas within the Department of Pathology are kept clean and well maintained. It is the responsibility of the Chief Medical Scientist to ensure that all maintenance requirements relating to work areas are communicated to the General Manager and the Maintenance Department as required.
The laboratory monitors, controls and records environment conditions, as required by relevant specifications or where they may influence the quality of the sample, results and /or the health of the staff. Attention is paid to factors such as light, sterility, dust, noxious or hazardous fumes, electromagnetic interference, radiation, humidity, electrical supply, temperature, sound and vibrations and workflow logistics, as appropriate to the activities concerned so that these do not invalidate the results or adversely affect the required quality of any examination.
The temperature of fridges, freezers, cold rooms and the room temperature are monitored either manually or by the Rees Centron Environmental Monitoring System, as defined in MP-GEN-0010 Management of the Rees Monitoring System. The system records temperatures at defined intervals, alerting where temperatures detected are beyond defined limits. Any deviation is investigated as non-conformity, as described in QP-GEN-0005 Control of Non-Conformances.
Environmental conditions are also assessed through the Audit Procedure, as defined in QP-GEN-0002 Evaluation and Audits.

In the laboratory, work is carried out at designated work stations.


There is effective separation between adjacent laboratory disciplines to prevent:


  • Incompatible activity operating in the one location

  • Cross-contamination

  • Excess noise levels

Environmental control is in place to ensure the Department of Pathology and environment is generally clean. This is described in LP-GEN-0016 Cleaning in the Laboratory.


The Laboratory provides a quiet and uninterrupted work environment where it is needed. The Department of Pathology requires an environment with adequate space, conducive to quiet and uninterrupted work, and all departments are located in separate rooms within the Department of Pathology.


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