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 The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued Guidance document for medical laboratories to ensure quality at the collection centres.
The document provides guidance to medical testing laboratories on the aspects like operation of sample collection centres or facilities (SCFs), sample format for preparing the scope of accreditation, lot verification, algorithm for automated selection and reporting of results, sample format for competency assessment and examples for the type of sample and their stability for clinical biochemistry parameters.
Maintaining the integrity of the test sample at all stages of collection, handling, transportation to the main laboratory and processing plays a vital role to ensure reliability of test results. Therefore, it is important to ensure quality at the collection centres.
There are three types of SCFs like ownership, management and franchisee. Ownership collection centres are owned by the laboratory or its parent organization and personnel are employees of the laboratory. Management laboratory or its parent organization does not own the collection centre but is entirely responsible for day-to-day operations and its employees. Franchisee laboratory or its parent company does not own the collection centre but has an arrangement for sample collection under an agreement e.g., hospitals, nursing home.
Apart from the above, laboratory shall declare details of all other source(s) of sample collection other than the medical laboratory or SCF. Laboratory shall ensure integrity of samples from these sources. They shall be assessed on a random basis by NABL, however, claim of recognition under recognized sample collection centre or facility cannot be made by laboratory or sources.
As per the collection centres/facilities guidelines, all issues related to the operation of collection centres and maintenance of quality shall be addressed by the laboratory in the quality system of the laboratory. Specific instructions for proper collection and handling of primary samples at the collection centre and transportation of these samples to the laboratory shall be documented in a primary sample collection manual, which shall be a part of the quality system of the laboratory and the collection centre.
Laboratory shall document policies and procedures to ensure maintenance of proper hygiene, lighting, environmental conditions and privacy in its collection centres. Collection centres should have adequate space to avoid any cross contamination. During the sample collection in collection centres, laboratory shall ensure the safety, comfort and privacy of the patients.
The laboratory shall have policies and procedures that integrity of the samples is not affected during collection, storage and transportation.
Collection centres shall ensure maintenance of required temperature during transport. Integrity of temperature sensitive parameters or analytes during transport of samples is a major concern in a distant testing scenario. Use of appropriate packaging material, of suitable and well insulated containers, of coolants (4 to 8°C) and dry ice (for ultra-cold temperature) are measures that help in maintaining stability of such samples, as per the guidance document.
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