The Indian Council for Medical Research (ICMR) has issued guidelines for Good Clinical Laboratory Practices (GCLP) outlining the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to provide quality data which can be used for health research and patient treatment. The guidelines aim to explain step wise procedures which should be followed by laboratories to strengthen the quality of test results.
The guidelines specify that GCLP should be followed by all laboratories where tests are done on biological specimens for diagnosis, patient care, disease control and research such as microbiology & serology, haematology & blood banking, molecular biology and molecular pathology, clinical pathology, clinical biochemistry, immunology (immunohaematology and immunobiochemistry), histopathology/pathology and cytology. Each laboratory should identify the scope, functions and the capacity of the services offered by it and appropriate infrastructure with requisite biosafety measures should be planned. Qualified and trained staff should be employed with periodic up-gradation of their skills.
As per the guidelines, the management should facilitate the setting up of biosafety precautions in the laboratory by providing adequate manpower, resources, infrastructure and policy. A biosecurity and/or biosafety officer should be overall in-charge of biosecurity/biosafety in the laboratory. The laboratories should have their own biosafety manual written in consultation with the head of the laboratory. Policies should outline the use of sharps, disposal of bio-waste, reagents, sharps and other wastes generated in the laboratory in accordance with Bio-Medical Waste (Management & Handling) Rules, 1998 (Amended in 2000).
On specimen collection, the guideline stipulates that as this is the first phase of interaction between the patient and the laboratory, appropriate counselling should be done before specimen collection and consent taken whenever needed. Attention should be paid to patient's sensibilities during the entire process. Any error in specimen collection can lead to erroneous results. It is therefore considered an important step of good clinical laboratory practice and is referred to as 'preanalytic control'. Specimen collection can be done at the patient's bedside, in the laboratory or in the field.
Laboratory should have a 'primary specimen collection manual', containing information on patient preparation before specimen collection (if any), exact methodology of specimen collection, labelling, handling, transportation and storage of the specimens. In addition, the laboratory should provide adequate and appropriate information/instructions to patients wherever necessary. All preanalytical factors that may influence the test results should be identified. The manual should include guidelines on specimen collection including preservation for histopathological examination. These manuals should be available for reference and should be used for training of staff engaged in specimen collection.
As far as infrastructure is concerned, the guidelines stipulate that the basic infrastructure facilities include: reception room/area where requisition forms are received and reports disbursed; specimen collection room/area; toilets; privacy for special purposes e.g. semen collection; facilities for disabled persons; toilet for staff; quality water supply for analytical purpose; uninterrupted power supply; analytical work area; specimen/sample/slide storage facility including cold storage where applicable; record room/area; facility for cleaning of glassware, sterilization /disinfection; waste disposal facility including biomedical wastes; fire-safety equipment; ventilation, climate control and lighting arrangements; separate room/area for meetings/administrative work; separate facilities/area for staff for hand washing, eating and storing food, drinks etc; communication facility with referral centres; transport of specimen/samples to referral centres and additional infrastructure facilities may be added for special tasks as and when needed.
The GCLP also specifies that each laboratory should designate a head of the laboratory who should be overall in-charge of the daily functioning of the laboratory including administration. A Quality Manager should be designated for monitoring and maintaining of day-to-day quality management system.
On the qualifications and experience of the staff, the guideline outlines that the NABL document 112 (2007) should be followed unless specified by the health care providers. The strength of staff employed should be appropriate to the level of facility and the workload. The roles and responsibilities of the staff should be clearly outlined.
Each laboratory should prepare an exhaustive list of equipment and consumables required and available for general functioning of the laboratory and specialized equipment for special tests. Laboratory equipment should be of adequate capacity to meet work load requirement. New equipment should be calibrated and validated before routine use. AMR (Analytical Measurement Range) should be verified, manufacturer can be consulted for verification and selection of range.