Medial(clinical) laboratories today, play a very important role in peoples’ health and welfare. These services are increasingly needed by hospitals, doctors and patients, in order to prevent the spread of disease, diagnose disease, and treatment of disease. Accordingly, the capability, quality of test results and putting in place an effective quality management system is being required even more.
In this background, how can a clinical laboratory make a convincing claim about its capability, and the advantage of a quality and high management potential? The most logical and acceptable answer to that is to be accredited as per highly acclaimed international standard, ISO 15189: 2003.
ISO 15189 standard is basically the application of the ISO/IEC 17025 and ISO 9001 standards to a clinical laboratory. The medical(clinical) laboratory is defined by ISO 15189 as follows:
“A laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation.
- Note – The examinations also include procedures for determining, measuring or otherwise describing the presence or absence of various substances of micro-organisms. Facilities which only collect or prepare specimens, or act a mailing and distribution centre, are not considered to be medical or clinical laboratories, although they may be a part of a large laboratory network or system.*”
Accreditation to ISO 15189 requires that:
The laboratory has a quality system meeting requirements of ISO 15189.
The lab facility has adequate equipment to perform its testing tasks.
The lab facility has adequate laboratory personnel with the competence to perform the testing.
In addition most accreditation schemes in the world require proficiency testing amongst the laboratories.
The intent of ISO 15189 is to provide confidence in medical laboratories because medical services are essential to patient care and therefore have to be available to meet the needs of all patients and the clinical personnel responsible for the care of those patients.
Laboratory accreditation, in general, provides a means of determining the competence of laboratories to perform specific types of testing, analysis, measurement and calibration. It enables people who want a product, material or instrument to be checked or calibrated to find a reliable testing or calibration service able to meet their needs. It also provides feedback to laboratories as to whether they are performing their work in accordance with international criteria for technical competence.
In case of clinical laboratories, testing and analysis services are needed by hospitals, doctors and patients, in order to prevent the spread of disease, diagnose disease, and treatment of disease. Hospitals, Nursing Homes and Dispensaries may also use laboratory accreditation to enhance the testing and analysis by their own in-house laboratories. Very importantly, laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for patients/doctors to identify and access reliable testing and calibration services for their health-care requirements.
Now the question is, how do you select a good laboratory? You have selected a Doctor. He examines you and write a requisition to a particular lab for certain tests. You don’t have a choice here. How to ensure that the results given by the lab are technically correct, as based on these results only the doctor is going to determine the treatment. How to go about it?
In my opinion, we should insist on our Doctor to select a lab which has a quality management system in place as per ISO 15189. We should also request the doctor to use his relations to impress upon the lab to go for third-party accreditation as per this international standard. It is a win-win situation for all, the paient, the Doctor, the lab.