The diagnostic dilemma

The lack of regulatory standards for diagnostic laboratories has given rise to questions about their practices but the laboratories find the quality control measures suggested by the National Accreditation Board tedious and expensive.

in Bangalore

BY ballpark estimates there maybe around a million clinical diagnostic laboratories in India, ranging from fully automated state-of-the-art establishments whose services are solicited by overseas hospitals and doctors, to makeshift structures equipped with just a dozen test tubes, a pipette and a technician. A vast majority are just collection centres drawing a sample and getting it tested at a `friendly' laboratory. These laboratories, irrespective of their wherewithal, claim to perform a variety of clinical tests in biochemistry, pathology, haematology, microbiology, histopathology, immunology and nuclear medicine among other fields.

There are no mandatory and scientifically determined standards for the laboratories. Given the penchant among doctors to use clinical tests as the determining factors in diagnosis, rather than as a corroborative tool, the lack of regulation is alarming. According to Dr. Sumedha Sahni, director (operations) of Speciality Ranbaxy Limited, hardly 25,000 laboratories have a fair level of instrumentation and a full complement of qualified staff.

All that one requires to start a clinical laboratory is a shop or commercial establishment licence from the local authority. In some States such as Uttar Pradesh even this is not required.

Some of the practices followed by the laboratories are questionable. For instance, are correct procedures employed when a sample is sent from one geographic location to another for analysis? Is the sample packed in dry ice as required? Is it analysed within the time limit set? Are the reagents used effective? Are the technicians competent? Are the tests duplicated and the mean value arrived at, as is the norm? Are adequate quality control (QC) checks undertaken? (The internationally followed practice of running QCs after every batch of tests is hardly ever followed in India. In fact, the majority of the laboratories are not even aware of QC.) Are the calibrators and standards (that come along with the pack of reagents) used of a high quality? Is the 20 to 40 per cent commission paid by the diagnostic centres to most doctors when they refer patients to them harming the system?

According to consumer protection activists, in a few instances patients have gone to two different laboratories and got different results for the same test.

The use of questionable methods is best illustrated in Bangalore's most requisitioned test: the thyroid profile. The test involves measuring the levels of the thyroid hormones Tri-iodothyronine (T3) and Thyroxine (T4) and the thyroid-stimulating hormone in blood. The test costs between Rs.150 and Rs.750, depending on where it is done. A leading laboratory that sends its samples to Mumbai charges between Rs.350 and Rs.500 for the test, depending on whether the radio-immuno assay or the chemiluminescence method is used. The cost also varies depending on whether the patient has been referred by an institution or has come independently. Reliable sources say that in the case of a patient who is referred, of the Rs.550 charged Rs.200 is paid to the doctor as commission. A patient who has come independently may be given a discount on the published rate of Rs.500.

The chief reasons for a lack of support for the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation process (see box) is its non-mandatory and rather expensive process. While in principle NABL's aim and procedures may be commendable, according to some laboratory owners, they are far from practical. The idea of getting as many laboratories to go in for accreditation is not happening. The reasons for this are myriad.

While some experts argue that making accreditation mandatory would improve the system, others are not so sure. Officials at the NABL point out that even if accreditation is made mandatory, only around 5,000 of the countless clinical laboratories would be in a position to apply for it. The rest would not be able to meet the quality standards required for accreditation. According to Dr. Anil Relia, Quality Manager, NABL, the intention of accreditation is to provide a means for "third party certification of the competence of laboratories to perform specific types of testing and calibrations and to provide formal recognition of competent laboratories, thereby providing a means for customers to find reliable testing and calibration services".

The expenses of getting accreditation are certainly on the higher side. Funds have to be set aside not only to maintain the quality levels that meet the NABL standards, but also for associated expenditure such as airfares and hospitality bills of the assessors. Clinical laboratory owners contend that the cost of securing NABL accreditation for a medium-sized laboratory will run up to Rs.1,50,000, which is much above the prescribed fee of Rs.10,000, Rs.20,000 and Rs.50,000 for small (up to 100 patients a day), medium (between 101 and 500 patients) and large (above 501 patients) laboratories respectively. The annual accreditation fee subsequent to initial accreditation is Rs.10,000.

Agrees Relia: "In a bid to reduce costs we are trying to send assessors who are from the same city or from somewhere nearby. At the moment we only have a pool of around 60 assessors, we are trying to increase it to 200. But in our estimate it should only cost around Rs.25,000. With the cost of operations being three times what we recover, the government is subsidising our operations."

According to Dr. H. N. Ravikumar, Quality Manager, RV Diagnostics, Bangalore (one of only two laboratories that has all its tests accredited), the costs are well worth it. He says that after getting accreditation, the quality practices at his laboratory are of international standards: "The confidence levels of the staff have gone up."

On the other hand, the criticism is that the documentation for accreditation is tedious (a doctor said it took him a year to read through it) and the time gap between pre-assessment and final assessment too long (even in excess of 12 months). The requirements for traceability of standards, machines, testing equipment and calibrations are too rigid and impractical. There are also administrative glitches: in a clear case of conflicting interests, a guide (who is a qualified assessor and is hired for a fee by the laboratory to help out with the accreditation documentation) was sent in as assessor.

According to a doctor who has been trying to secure accreditation for his laboratory, the traceability of calibration standards for testing equipment is impractical and expensive (sometimes almost the cost of the equipment itself). He said: "NABL insists that the calibration of all testing equipment has to be done only at an NABL accredited testing centre. This is not always possible. For example, even if I have to calibrate a thermometer or a pipette I have to go to Chennai or Nagpur. NABL also pulls us up if we are unable to provide traceability of equipment to an NABL-certified laboratory. The manufacturer tells us that his equipment has traceability to the World Health Organisation, but this does not convince the NABL. Why can't the NABL tie up with the licensing authority and regulate manufacturers who sell equipment in India? It can then certify whether the equipment meets the requisite standards. The NABL should also allow us to make use of the facilities at any statutory body/agency that is approved by the government as calibrating centres such as the National Physical Laboratory, Geological Survey of India and Electronics Testing and Development Centre."

Another doctor who runs a small laboratory said: "Much of the equipment that we buy are manufactured outside India and are closed systems. The manufacturers do not heed our pleas for a regular supply of reagents and sera. They make available only big-sized packs, which, given the short shelf life, go waste after a time. This increases our costs. The NABL should pressure the government to encourage Indian companies to manufacture biomedical equipment and offer tax exemptions for imported items."

There are also complaints that the NABL has not evolved its own protocol for standardisation, be it for machines, reagents and calibration. The NABL follows standards set by the globally recognised National Committee for Clinical Laboratory Standards. According to Relia, efforts have been made to standardise assessors.

Other impediments, which doctors feel are overstressed include NABL's non-technical directives, including the use of specified colours of paint on the walls of a laboratory, air-conditioning facilities, minutes of management meetings, internal audits, feedback from customers and the frequency of review meetings.

The moot question is whether the accreditation process should be made cheaper and simplified and most important, mandatory for all tests.