RESOURCE MANAGEMENT IN CLINICAL LABORATORY

RESOURCE MANAGEMENT IN CLINICAL LABORATORY

Top management must provide the resources necessary to both meet the quality management system requirements and to continually improve its effectiveness. It must also provide the resources needed “to enhance customer satisfaction by meeting customer requirements. Managing resources to effectively meet the requirements of the quality management system and customers means securing enough people and ensuring their competence, awareness, and training to meet those goals. It also means providing the right equipment, a suitable infrastructure and work environment, and supplies for personnel to do their job effectively.

Personnel

Management must ensure laboratory personnel are competent by determining if they have the appropriate education, training, skills, and experience. They must determine what criteria to use to determine competence, provide personnel with required training or other appropriate action, and evaluate the effectiveness of the training. Personnel must understand why their competence is important and the role they play in meeting an organization’s quality objectives. An organization must also provide evidence of an employee’s competence by maintaining records of education, training, skills, and experience. The laboratory should provide training for all personnel which includes the following areas -

Ø  the quality management system;

Ø  assigned work processes and procedures;

Ø  the applicable laboratory information system;

Ø  health and safety, including the prevention or containment of the effects of adverse incidents;

Ø  ethics;

Ø  confidentiality of patient information.

Personnel that are undergoing training should be supervised at all times. The effectiveness of the training programme should be periodically reviewed. Reassessment should take place at regular intervals. Retraining should occur when necessary. In addition to the assessment of technical competence, the laboratory should ensure that reviews of staff performance consider the needs of the laboratory and of the individual in order to maintain or improve the quality of service given to the users and encourage productive working relationships. A continuing education programme should be available to personnel who participate in managerial and technical processes. Personnel should take part in continuing education. The effectiveness of the continuing education programme should be periodically reviewed. Personnel should take part in regular professional development or other professional liaison activities.

Accommodations and Environmental Conditions

Employee competence is not enough. Employees must also be provided with a suitable work environment that will allow them to carry out their activities to meet customer requirements and the requirements of the quality management system. This includes providing workspaces, equipment, and supplies, as well as supporting services, such as information systems. The laboratory and associated office facilities should provide an environment suitable for the tasks to be undertaken, to ensure the following conditions are met.

Ø  Access to areas affecting the quality of examinations is controlled.

Ø  Medical information, patient samples, and laboratory resources are safeguarded from unauthorized access.

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

Ø  Communication systems within the laboratory are appropriate to the size and complexity of the facility to ensure the efficient transfer of information.

Ø  Safety facilities and devices are provided and their functioning regularly verified.

There should be adequate access to washrooms, to a supply of drinking water and to facilities for storage of personal protective equipment and clothing.

Laboratory Equipment

Laboratory must have all the equipment required for the provision of its services. Labs must also put a process in place that describes how they select equipment. This should include a method for evaluating suppliers of laboratory reagents, supplies, and services. ISO 15189 clause 4.6.4 specifies labs must maintain records of these evaluations. Supplier evaluations can be done through the following methods:

Ø  Audit on-site inspection

Ø  Requiring proof of external evaluation to the ISO 15189 standard

Ø  Asking companies to provide quality control records

But suppliers do not have to be ISO registered or accredited. The laboratory should have a documented procedure for the selection and purchasing of external services, equipment, reagents and consumable supplies that affect the quality of its service. The laboratory should select and approve suppliers based on their ability to supply external services, equipment, reagents and consumable supplies in accordance with the laboratory’s requirements; however, it may be necessary to collaborate with other organizational departments or functions to fulfill this requirement. Criteria for selection should be established.

A list of selected and approved suppliers of equipment, reagents and consumables should be maintained. Purchasing information should describe the requirements for the product or service to be purchased. The laboratory should monitor the performance of suppliers to ensure that purchased services or items consistently meet the stated criteria

The laboratory should verify upon installation and before use that the equipment is capable of achieving the necessary performance and that it complies with requirements relevant to any examinations concerned. Equipment should be operated at all times by trained and authorized personnel. Current instructions on the use, safety and maintenance of equipment, including any relevant manuals and directions for use provided by the manufacturer of the equipment, should be readily available. The laboratory should have procedures for safe handling, transport, storage and use of equipment to prevent its contamination or deterioration. The laboratory should have a documented procedure for the calibration of equipment that directly or indirectly affects examination results. This procedure includes:

Ø  taking into account conditions of use and the manufacturer’s instructions;

Ø  recording the metrological traceability of the calibration standard and the traceable calibration of the item of equipment;

Ø  verifying the required measurement accuracy and the functioning of the measuring system at defined intervals;

Ø  recording the calibration status and date of recalibration;

Ø  ensuring that, where calibration gives rise to a set of correction factors, the previous calibration factors are correctly updated;

Ø  safeguards to prevent adjustments or tampering that might invalidate examination results

The laboratory should have a documented programme of preventive maintenance which, at a minimum, follows the manufacturer’s instructions. Equipment should be maintained in a safe working condition and in working order. This should include examination of electrical safety, emergency stop devices where they exist and the safe handling and disposal of chemical, radioactive and biological materials by authorized persons. At a minimum, manufacturer’s schedules or instructions, or both, should be used. Whenever equipment is found to be defective, it should be taken out of service and clearly labeled. The laboratory should ensure that defective equipment is not used until it has been repaired and shown by verification to meet specified acceptance criteria. The laboratory should examine the effect of any defects on previous examinations and institute immediate action or corrective action.

The laboratory should take reasonable measures to decontaminate equipment before service, repair or decommissioning, provide suitable space for repairs and provide appropriate personal protective equipment. When equipment is removed from the direct control of the laboratory, the laboratory should ensure that its performance is verified before being returned to laboratory use. Adverse incidents and accidents that can be attributed directly to specific equipment should be investigated and reported to the manufacturer and appropriate authorities, as required. Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment, should be verified for performance before use in examinations. Consumables that can affect the quality of examinations should be verified for performance before use in Examinations.

The laboratory should establish an inventory control system for reagents and consumables. The system for inventory control should segregate uninspected and unacceptable reagents and consumables from those that have been accepted for use. Instructions for the use of reagents and consumables, including those provided by the manufacturers, should be readily available. Adverse incidents and accidents that can be attributed directly to specific reagents or consumables should be investigated and reported to the manufacturer and appropriate authorities, as required.