Medical laboratory: A building block of trust
Laboratory tests are among the most important and pervasive aspects of modern medicine. The results of clinical laboratory tests contribute to the majority of healthcare decisions. Laboratory tests provide the healthcare practitioners with the information for decisions from diagnosis through therapy and prognosis. For some conditions, there is just no substitute for a laboratory test.
Healthcare practitioners rely on the laboratory for help in diagnosing any number of conditions and for managing their treatment. They trust the results that the laboratories produce. However, reports of inaccurate laboratory reports are heard from time to time, and so a reasonable question for any patient is: should I trust my laboratory results?
The short answer is yes, you can have as much trust in these results as your healthcare practitioner does when the laboratory adheres to many protections to ensure that they produce reliable results. These protections and guidelines are instituted by trusted laboratory accrediting bodies like the National Board for Testing and Calibration Laboratories (NABL) and the individual laboratories themselves to help maintain standards of quality. In addition, there are steps that one can personally take to further increase one’s comfort with the quality of the laboratory’s results, including questions that could be personally asked to the healthcare practitioner.
THE GOVERNMENT AND LABORATORY REGULATIONS
There are Gazette Notification of Minimum Standards of Medical Diagnostic Laboratories (or Pathological Laboratories). Ministry of Health and Family Welfare (Department of Health and Family Welfare) lays down many important guidelines in its Clinical Establishments (Registration and Regulations) Amendment Rules, 2018.
The state governments through its respective Health Directorates lay down its own Clinics and Nursing Homes Registration Acts that provide strict guidelines that pertain to the scope of the tests performed, infrastructure, safety rules, human resource, instruments and equipment, legal or statutory requirements, record maintenance or reporting, etc.
LABORATORY ACCREDITING ORGANISATIONS
The most visible line of defence for accurate laboratory test results is the respected accrediting bodies like the National Accreditation Board for Testing and Calibration Laboratories (NABL) that oversee laboratories that are enrolled in their accreditation programmes. To make sure that the accredited laboratories are following the requirements outlined in the NABL guidelines (ISO 15189), the laboratories performing moderate and/or high complexity testing must undergo regular inspections every two years. Several particularly important areas for inspection are personnel training and competency requirements, proficiency testing, performance improvement, quality control requirements and the whole gamut of quality control programmes and activities of the laboratory.
Following an audit or an assessment of a laboratory, the state agency or accrediting organisation will provide the laboratory with the list of areas in which it did not meet requirements (non-compliances), or deficiencies identified during the inspection.
The laboratory will be required to make improvements to bring them into compliance with requirements. Laboratories must then submit documentation or a plan of correction to address the inspection findings. State agencies and accrediting bodies offer support and guidance during the post-survey period to help the laboratory staff understand the requirements and make sure that their plan of correction is implemented correctly. They often leave the laboratories with recommendations on how they can improve their processes or be more efficient.
To ensure that you are receiving the bet quality services, there are steps you can take to check for yourself.
· Your first consideration is the kind of laboratory that will be testing your specimen. Is it accredited? You could find out if the laboratory participates in any outside education or quality checking programmes.
· You could find out the qualification and the competency of the people who will be performing or authenticating your tests. Can the laboratory people explain to you the specified procedures in detail? Is the laboratory following proper specimen labelling and handling procedures?
· You could find out the information on the technology and the methodology employed to run your tests. Are the instruments validated?
· The sample collection process itself could provide you some clues: was the specimen properly labelled? Was it barcoded to do away with sample-patient mismatch? Were you given clear and adequate instructions if you had to collect the sample yourself (urine, sputum, stool, etc.)? Did the person collecting your sample verify your identity?
· Is your doctor aware of the laboratory’s accreditation status? You could always check it up in the laboratory’s information booklet or its official website.
LACK OF ACCREDITATION STILL A CONCERN
India has more than one lakh medical laboratories and less than 1% of total are accredited. Low entry barriers amid lack of proper regulations continue to be a problem for more established laboratories.
There is no stratification of labs and there is lack of awareness too among the general population. Most people don’t know the difference between an accredited laboratory and the one which is not accredited. The problem is, accreditation is a voluntary process and it is not proposed to be enforced on clinical establishments, including laboratories. However, with increased awareness among the general public, it is expected that the number of laboratories applying for accreditation will increase. And that can only be for the greater common good.
(The writer is Managing Director &Senior Consultant Pathologist, BABINA Diagnostics, Imphal)