Kathmandu, June 9

Test, test and test, there is no other way out. I am sure you all would know what I am referring to- “COVID-19” testing indeed. The pandemic has made the world realise the importance of laboratory testing. Like elsewhere in the world, Nepal has also finally realized the importance of a good laboratory for accurate testing. RT-PCR, RDT, sensitivity, specificity, false positive, false negative etc, are jargon used even by commoners nowadays. The awareness surrounding these medical terms is good but how assured are the public that they are being provided with accurate laboratory results, not just for COVID-19 test, but for a simple test like fasting blood glucose?

Variation in laboratory results from one lab to another has always created mistrust among patients as well as treating physicians. Why are there test result variations? Is a certain degree of variation acceptable? Which laboratory should I trust? How do I choose a good laboratory? These are few of the many questions that often cross our minds as consumers. To answer all the above questions, we have to have quality assurance through standardization in our laboratory practice, which will ensure that we get similar results, no matter which laboratory we go to. So how can we be assured for quality and reliability of test results that we get from a laboratory?

How do we assure quality in a laboratory result?

The simple and basic answer to the above question is Laboratory Accreditation with ISO 15189. Accreditation is a procedure by which an authoritative body (Accreditation body) gives formal recognition that an organization is competent to carry out specific tests. The recognition is at an international level. It is a third party recognition that the laboratory is competent, impartial and independent in meeting the testing needs of the patient. When I say my lab is good and we have good quality control in place, that means first party accreditation. When my friends say that my lab is a quality lab, its called second party accreditation. But when an independent accreditation body inspects us and says that our quality is assured, then that is third party accreditation, and that is what we should strive for.

World accreditation day, 2020, is being celebrated on June 9 with the theme “Accreditation: Improving Food Safety.”  Food born diseases are a public health concern with nearly 600 million people getting sick from related ailments every year. Accredited conformity services in the food industry are of vital importance since good health and well being are maintained by safe and nutritious food. Quality of the food product has to be assured before being sold in the national or international market. The food product is being tested in an accredited food testing laboratory and a certificate is issued which ensures food safety to the consumers. The food supply chain involving the production, transport, processing and packaging, distribution, storage, retail distribution till the final point of catering is being inspected and certified by an accreditation body so that we get to eat safe food. Thankfully, there is a process of quality control in the food industry. But, please keep in mind that not all countries have such stringent criteria to ensure food safety. Of late, Nepalis have been aware regarding food safety and as I see in supermarkets, people have developed the habit of inspecting the food package for manufacture date, expiry date, or some other form of certification. Similarly, shouldn’t there be patient safety in hospitals and diagnostic facilities? Shouldn’t you be checking the quality of the laboratory that you go for your blood tests? Wouldn’t you want all laboratory testing facilities to be of the same quality so that you are assured of your safety as a patient. Indeed, I would like to be assured of quality results regardless of the health care facility I use. So how can patient safety be assured in a health care facility?

Patient safety

As per the World Health Organisation, patient safety is the absence of preventable harm to a patient during the process of health care and reduction of risk of unnecessary harm associated with health care to an acceptable minimum. Patient safety should be the main concern of any health care institution. Quality patient care should be assured in all the facilities provided by the hospital. Quality assurance driven by accreditation encompasses set processes which finally contribute and lead to patient safety, which is the aim of all health professionals and medical services. Patient safety is the cornerstone of high quality patient care. So how can patient safety be assured in a medical facility? The answer, again, is accreditation.

There is a misconception in Nepal that hospital accreditation by ISO 9001 series shows their competence. Well that is wrong, and it leads us to the next question, Is ISO 9001 certification and ISO 15189 accreditation the same?

Accreditation can be done for the whole hospital, radiology services, pathology laboratory, blood bank and other areas. Accreditation of the pathology laboratory is very vital in ensuring patient safety by providing accurate and reliable test reports.  ISO Accreditation is superior to ISO certification for health care institutions.

Accreditation and ISO certification are two different entities-- and that needs to be understood by consumers. Certification to ISO 9001 establishes compliance of the quality management system to the standard and it does not contain technical requirements for lab personnel and operators. ISO 9001 certification is usually used by business establishments to show their compliance to management activities. On the contrary, accreditation to ISO 15189 emphasizes on the establishment of technical competence for a defined set of tests. It ensures both technical competence as well as management compliance.

Who provides laboratory accreditation?

Lab quality begins with you! Only then we can look formally via an accreditation process as mentioned above.

General requirements for the competence of testing and calibration laboratories began in 1977 at the international laboratory accreditation corporation (ILAC) conference held in Denmark. There have been many amendments to the original document for quality testing and competence in a pathology laboratory since its introduction as ISO 15189 in the year 2003. The third version used now is ISO 15189:2012.

All accreditation bodies fall under the umbrella of ILAC. There are regional bodies such as EA, APLAC, IAAC, SADCA under the parenting of ILAC. Each country has its own accreditation body, which is affiliated through the regional body to ILAC. Similar to the accreditation bodies in other countries like India which has NABL or NABH, Nepal also has its own accreditation body. Accreditation Education Research and Scientific Service Center (AERSSC) is the accreditation body responsible for testing and certifying medical laboratories. AERSSC is a full member of APLAC (An Asia Pacific regional body of ILAC) and an associate member of ILAC.

Why use an Accredited Laboratory?

“False positive- False Negative” these need to be the thing of the past, and we as health individuals need to be assured that our tests are “Negative or Positive- no compromise.”

Quality is always customer driven. The society should be aware about how to identify a good laboratory for accurate results. Patients and doctors usually complain of varied results from different labs. Well, certain degree of variations, both due to analytical process as well as from biological variation, are accepted. If you have any doubts or queries, talk to the laboratory physician rather than assuming that the test results are wrong.

Once again, to standardise and to bring uniformity in results, the magic word is 'accreditation'.

Accreditation of a laboratory ensures that the lab is following all international guidelines of ISO 15189. The technical competency of a lab, which reflects the quality of the result, is based on a lot of factors, from the time the physician selects a laboratory test till the transmission of test results to the physician. This involves a loop of five phases, namely pre-pre analytical, pre-analytical, analytical, post analytical, post-post analytical phase. An accredited lab is inspected regularly to assess their compliance to all the phases. Minute details pertaining to patient safety is being evaluated. This evaluation ensures that there is a system driven process is in place which shall ultimately be reflected as accurate and reliable lab reports.

Technical competence of the laboratory depends on the following factors which are assessed during accreditation body inspection: the qualification, training and experience of the staff, the right equipment properly calibrated and maintained, adequate quality assurance procedures, proper sampling practices, appropriate testing procedures, valid test methods, accurate recording and reporting procedures and suitable testing facilities.

In the pre-pre-analytical process, it is the laboratory's responsibility to make aware the physician regarding available tests and their utility. The pre-analytical phase is very crucial since research shows that nearly 70% of all laboratory errors occur before the analytical phase. This phase includes availability of information for patients and users, request forms details, sample collection, handling and transport, things to do while collecting sample, sample reception and storage. Each process is analysed and inspected in detail so that proper results can be expected. The analytical phase includes verification and validation of tests and instruments ensuring quality control, SOP’s and a lot of analysis. Post analytical phase includes review of results, patient consultation of results, along with storage, retention and proper disposal of clinical samples. Post post analytical phase reflects the interpretation of the test by the treating physician.

As you can see it is a pretty long loop and it is easy to deviate from the set standards for a regular lab, but an accredited lab has to adhere to all the above processes, which finally contributes to accuracy of results. These are just few of the rules and procedures followed in an accredited laboratory. A lot of other areas of competency are also analysed.

We can now see how important accreditation is. In most of the developed countries, accreditation of a medical lab is mandatory. Where as in developing countries, accreditation is a voluntary act. In Nepal it is done voluntarily hence to assure standardisation of results across different labs in the country, the customers should be aware and visit only accredited centers so that other labs are also compelled to become accredited. This would lead to the patients being assured of the quality of their laboratory test results. Physicians should also be aware of what laboratory accreditation is and how it helps them, help their patient to be safe and healthy.

The need for quality is now know, so let us act on it.

Dr. Keyoor Gautam, MD is a Pathologist and the Chairman of Samyak Diagnostic.