The challenge faced by labs to maintain quality and accreditation is the cost involved in these factors.
Medical laboratories have a great role in today’s healthcare. The time has gone where diagnosis and treatment by physicians were based on mere assumptions or “trial and error” basis. Today 70% of clinical decisions are taken based on laboratory reports. Without accurate and timely laboratory information, these decisions which are directly linked with patients’ therapeutic outcome, would be compromised at best. Hence it is very much important that a medical laboratory ensures global quality standards. However in a country like India, where approximately 1,00,000 medical laboratories are functional, only about 1000 (1% of total number) labs are accredited by NABL or other accredited agencies. Though quality may not always and necessarily be synonymous with accreditation, the scenario certainly raises a doubt about the number of medical laboratories in India which follow at least the very basic quality practices. This is also evident from the statistical analysis of available data from various laboratories that opted for accreditation but could not obtain the same due to inability to fulfill the requirements as per set guidelines. This situation raises a serious concern and poses a threat to the overall quality of the healthcare sector of the country.
As we are all aware, since the last few years, Indian diagnostic market has seen a boom due to robust improvement in infrastructure and better availability of cutting edge technologies which are comparable with global standards. The growth was driven by increase in prevalence of lifestyle disorders, chronic diseases, rising income level, ageing population, growing health awareness and resultant high focus on early diagnosis of diseases. All these have again underlined the importance of good quality laboratories across the country as laboratory reports largely influence diagnosis and treatment protocol.
The advantages of Indian diagnostic (laboratory) sector are its highly competent manpower along with its service which is quite affordable in comparison to European or American markets. However the disadvantage lies in the unorganized, unregulated, fragmented players which largely dominate the Indian market. Country’s lab medicine market has lots of potential to reach at its best provided quality control can be ensured at every level be it small, standalone laboratories or corporate giants or diagnostic chains. Some sort of regulation from the Government and ensuring a minimum, basic quality standard must be made mandatory to open a laboratory and continue operation in India.
Another aspect to be noted is asymmetry in distribution of labs between rural and urban areas in India. Most of the big, good quality, better equipped private and public laboratories are situated in urban areas whereas rural people are mostly dependent either on small public facilities or unregulated, small, unaccredited standalone private laboratories. Hence uniform distribution of good quality laboratories with better infrastructure is the need of the hour. Not only basic, routine tests, even specialized tests should also be available at least to some extent in remote areas to save time to initiate treatment.
Quality of a medical laboratory may be judged on several performance matrices however, the quality of reports and TAT (turnaround time) are of foremost importance. Accurate, error free, faster reports towards direction to therapy (not only numerical values) are expected from a lab by both patients and physicians. Here one should remember that quality control in a lab should be monitored not only during the testing process (analytical process) but also in preanalytical (sample collection, proper labeling, transport etc.) as well as in post analytical segments (data entry, report delivery, data safety etc.). If the sample quality is not maintained and samples get compromised during collection, transport or handling, good quality reports can never be ensured even if you have the best quality equipment in your lab. At the same time, wrong data entry can lead to a catastrophe. Bidirectional interfacing (direct data transfer from equipment to laboratory information management system), regular and periodic transcription check in case of manual entry can minimize the possibility of manual or clerical error. Easy access to lab and affordability are also vital parameters considering remote areas and people of India coming from different socioeconomic backgrounds. As a whole, a good quality laboratory earns its reputation by generating confidence and trust among its customers by its patient-centric approach. Adoption of high quality, latest technologies, certain degree of automation with trained and competent manpower and supervisors (technicians, MD Pathologists/Biochemists/Microbiologists) make all these tasks easy for a laboratory. Accreditation by NABL, NABH, CAP etc. certainly adds additional feathers to all these.
The challenge faced by labs to maintain quality and accreditation is the cost involved in these factors. However once you bring quality at your doorstep, you understand the benefit of it. The solution is to approach gradually and step by step. Once the basic quality practices are ensured, laboratories should be encouraged to achieve the next level of quality standards for further improvement. Though the initial cost is high, the ROI (return of investment) is substantial as maintaining quality ultimately saves your cost in view of comparatively much better performance of equipment, less requirement of repeat analysis, lesser number of negative feedbacks or complaints due to better customer satisfaction.
Government and accreditation agencies have also big roles to play here. Setting up more laboratories in rural and remote areas, PPP (public private partnership) models, promotion of digital pathology, availability of point of care testing devices (bedside testing) in remote areas are some of the steps which should be considered. Launch of mobile applications to find out nearby laboratories with quality based ranking, better availability of government authorized lab technician training courses, raising awareness among public regarding importance of availability of lab medicine practitioners (MD Pathologist/Biochemists/Microbiologists) in a laboratory, promoting for basic quality norms and importance of accreditation will also prove beneficial and can entirely change the face of practice of modern laboratory medicine in India. Time has come to rethink whether accreditation will still be kept purely voluntary for laboratories in India!
Moreover, the Government may consider investing more in major and minor laboratory equipment manufacturing units so that the cost of automation in a laboratory can be drastically reduced. Automation under supervision of a trained laboratory medicine practitioner has already proved to be a game changer and can significantly reduce pre analytical, analytical or post analytical errors in a laboratory.
Today laboratory medicine is not only restricted in helping clinicians in accurate diagnosis and taking treatment related decisions but also has expanded to provide preventive and wellness healthcare. No doubt that, laboratory medicine will be more and more intimately associated with patients’ management with each passing day. Hence it is absolutely necessary to ensure quality assurance in this sector that too uniformly, even at grass root level in every possible way.
Let's take an oath of “not to opt for the nearest lab but to opt for the nearest quality lab”.
The writer, with almost 9 years of experience as a Consultant Pathologist, is currently the Chief of Quality and Senior Consultant Pathologist in Suraksha Diagnostic, Newtown, Kolkata. He maintains the ultimate responsibility for the overall quality assurance of the Central laboratory in Kolkata as well as the satellite labs and around 40 centres of Suraksha located in different parts of Kolkata and districts. Apart from laboratory quality control, he holds special interest in routine and specialized chemistry, LC-MS/MS technology, preanalytical variables affecting laboratory results, sales training, process upgradation, development of new set ups etc. He had earlier worked with SRL Diagnostics, Central Clinical Reference Lab, Goregaon, Mumbai and Rajawadi Hospital, Ghatkopar, Mumbai. He is experienced in facing and handling CAP, NABL and various CRS audits. In his present organization, he had set up the first LC-MS/MS (Tandem mass spectrometry) set up for any clinical laboratory in Eastern India. He has appeared as speakers and panelists in several CMEs, workshops, symposiums at different locations in India. He has many published case reports and articles in reputed National journals and healthcare magazines.
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