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The diagnostic rip-off

Print edition : Nov 22, 2002 T+T-

While the health care industry has welcomed the corporatisation of diagnostic laboratories, serious questions persist on the quality of service many of these small as well as big players offer and the rates they charge.

PATHOLOGICAL tests were in recent decades virtually the preserve of corner-store pathologists. Today they are big business, with more than 25,000 clinical laboratories carrying out around 11 lakh tests daily. These range from routine examinations of blood sugar and cholesterol levels to complicated hormonal assays and immunological investigations. A number of pharmaceutical majors, home-grown laboratory chains and foreign players have set up shop around the country in the last five years for a slice of the Indian pathological pie.

Corporate entities such as Raptakos Brett, Speciality Ranbaxy Laboratories (SRL), Nicholas Piramal, Pathnet (a collaboration between Dr. Reddy's Laboratories and the Australian Gribbles Group) are in competition with laboratories like Elbit, Medinova, Ehrlich, Anands, Dr. Lal's, Thyrocare and Metropolis.

The growth in the number of the middle classes, coupled with the demand for affordable health insurance for an ageing population, is expected to translate into an exponential growth for diagnostic laboratories. According to doctors and others from the health care industry, the corporatisation of diagnostic laboratories with the entry of players operating nationally will not only help standardise the hitherto unorganised sector but also give a fillip to the health insurance sector.

But, for obvious business reasons, most players have so far restricted themselves to urban areas, and that too certain regions. For example, Elbit and Medinova are well-known in the South (mainly Bangalore and Hyderabad), Dr. Lal's and Pathnet in the North (in the Delhi region), and SRL in the Western region. While semi-urban areas are served through a network of collection centres, which draw the test samples and send them to the city-based laboratories for diagnosis, rural regions are still uncovered.

Many of these diagnostic centres are also equipped to perform radiological tests (X-rays, computerised tomography or CT scans and magnetic resonance imaging, or MRI) and cardiological (treadmill, electrocardiograms and so on) tests that lead to a more effective system of diagnosis and patient management. However, serious questions persist on the quality of service many of these small as well as big players offer and the rates they charge.

Today practically anyone can start a diagnostic laboratory or centre in India. All that one needs is a shop or establishment licence from the local body. In Uttar Pradesh and some other States even this is not needed. According to Dr. Sumedha Sahni, director (operations) of SRL, Maharashtra and Gujarat have around 500,000 small laboratories that do clinical tests. Many of these centres do not have even a single qualified pathologist on a full-time basis; they make do with technicians. What is actually required is a team of full-fledged pathologists, each with expertise in one particular field tissue pathology, immunology, haematology or transfusion medicine, and so on.

Said Dr. P.R. Krishnaswamy, honorary director of Manipal Hospital, Bangalore, who is in charge of the hospital's diagnostic laboratory and radiology department:

``Earlier, when technology was not as advanced as it is now, patients went to a pathologist for a blood test, a little microbiological culture, blood sugar, cholesterol or liver function test. Pathologists had a clear understanding of most of these tests and the service was adequate to help the clinician.

``Today a host of tests have emerged, and unless the laboratory has the right kind of equipment and quality technologists, it will get into trouble with quality control. This has to be moderated. The smaller laboratories should restrict themselves to doing routine tests and not claim that they have the expertise to do higher-end analysis. But in reality what is happening is that they do everything and when they cannot do something they send the samples to a speciality laboratory where they don't have any control to validate the results.''

Each clinical testing system has a vigorous quality control check built into it and no test result should be acceptable unless the quality control sera, which are commercially available and whose readings are known, are run on the system and the results obtained are within the specified reference ranges. Checks with sera samples are done in order to run a qualitative check on the laboratory's equipment, reagents and procedures. Specimens from the laboratory are also required to be sent periodically to reference laboratories such as the one at Christian Medical College Hospital, Vellore, or even overseas to validate the results.

Of the more than 25,000 clinical laboratories in India, barely a dozen are accredited with the National Accreditation Board for Testing and Calibration Laboratories (NABL), which comes under the Union Ministry of Science and Technology. Red tape and the expensive nature of the process of NABL accreditation maintaining quality levels that meet NABL approval and being forced to meet associated expenditure not strictly conforming to the professional aspects of the process have been among the impediments to laboratories seeking it. NABL directives include the use of specified colours of paint on the walls of a laboratory, air-conditioned facilities, specified maintenance standards for the machinery, norms with regard to the number of days for which samples have to be retained after tests, and, of course, specifications with regard to operating procedures.

In the absence of a well-enforced system of certification and meaningful regulatory legislation, laboratories continue to have a free hand. According to consumer protection activists, in quite a few instances patients have gone to two different laboratories and got different results for the same test. There are other questionable practices. For instance, when a sample is sent from Bangalore to Mumbai for analysis, are the correct procedures employed? 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?

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 (TSH) 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.460 and Rs.550 for the test, depending on whether the radio-immuno assay (RIA) or the chemiluminescence (CLIA) 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, Rs.200 is the profit of the laboratory's local office and Rs.150 is sent to its head office. A patient who has come independently may be given a discount on the published rate of Rs.550.

Many laboratories have networks of their offices to ensure regular collection of samples from hospitals, nursing homes and clinical laboratories that do not perform thyroid profiles. The samples are sent to Mumbai for analysis and the results are mailed back electronically. In the case of patients from hospitals, the hospitals put the results on their own letterheads and give them to the patients, of course with a mark-up in the cost.

Some doctors are critical of tests conducted in centres that do not draw the sample directly from the patient. This, according to them, breaks the crucial link between the referring doctor, the technologist and the patient. One doctor claimed that when the values obtained in tests were abnormal, many of these out-station laboratories, instead of redoing the tests and then speaking to the referring doctor, suppressed the results and concocted borderline reports. This, he said, was done because they were not sure of themselves and did not want to get caught on the wrong foot. There are also instances of doctors frowning at genuinely abnormal readings and insinuating that faulty equipment in the laboratory caused them.

PATHOLOGICAL tests are undoubtedly important tools in diagnosis, and this has led to a situation where doctors send patients straight away for a series of clinical tests without waiting to check for symptoms in making diagnoses. ``In the past diagnostic tools were few, and a clinician depended on his listening ability and observations. Today most doctors and consultants hardly have the time or the inclination to listen to the patient,'' said a doctor who did not want to be named. This gives rise to the question: Are these tests used for the benefit of patients or are they plain money-spinners?

Visits to a number of clinical laboratories, diagnostic centres, doctors and consultants in Bangalore revealed that the marketing arms of equipment manufacturers, pharmaceutical companies and diagnostic laboratories were driving the clinical testing and diagnostics market much more than medical requirements. The situation is apparently no different in the rest of the country.

According to a leading doctor in Bangalore, many of these tests are done mostly for documentation, with the clinical presentation hardly taken into consideration in making the diagnosis. He said that a large number of the MRIs that are performed are not really needed. "Today, in Bangalore we have more CT (around 20) and MRI (around six) scanners than some counties in the United Kingdom. Most countries, even advanced ones, use these pieces of equipment diligently. But here the only concern is to recover the cost of the equipment (an MRI scanner costs Rs.3 crores) and as quickly as possible. That is why you have so many MRIs and CT scans being asked for."

Every referral that a doctor makes often means a 20 to 40 per cent commission on the amount charged to the patient by the laboratory/centre, variously called `interpretation charges' (IC), `referring charges' or plain `commission'. This has meant that in many a case the patient is unnecessarily sent to diagnostic centres. Reliable sources in the health care industry say that at least 60 per cent of all doctors take commissions.

Most, if not all, hospitals pay commissions for tests like CT scans and MRIs. They also insist that their doctors and consultants refer patients only to in-house diagnostic establishments. Many consultants told Frontline they had no choice but to comply as they were dependent on the hospitals for patients.

The Indian Medical Association (IMA) is ``very much aware of the problem'' but finds it difficult to take action. Said Dr. Ketan Desai, President of the IMA: ``We as a body have never approved of this. We have condemned this practice at every forum. The Medical Council of India in its amended `code of ethics' has included a clause wherein doctors found guilty of accepting commissions will have to face punishment, even the taking away of their registration.'' If finding proof is one thing, equally crucial is the question of how much teeth the IMA has, with a membership of hardly a third of the country's 4,50,000 doctors.

The system of paying commissions is so well-entrenched that when Dr. Krishnaswamy started a small collection centre for blood samples near Bangalore's City Market and announced that he would do 15 different blood tests at highly subsidised rates, he got hardly any response. The patients at the government hospitals located in the areas preferred to go to expensive diagnostic laboratories close by, apparently at the instance of their doctors. Said Krishnaswamy: ``If I said that I would do a blood sugar test for Rs.10 or even Rs.5, I won't get references. No one will come. Doctors would tell me, `Charge Rs.25 and give us Rs.10'.''

While the costs vary greatly at different laboratories for the same tests, the rates are sharply above what they should be. Krishnaswamy, who worked for 19 years at Mumbai's Jaslok Hospital, admitted that a blood test, which costs a laboratory just Rs.6, costs the patient at least Rs.40. Some doctors said that hospitals, even the corporate ones, should ensure that tests are done free, or at least at highly subsidised rates, once they have recovered the cost of the equipment. This was the only way economically weak patients could benefit from facilities, they felt.

According to most doctors, many of the problems in this regard are caused by the ingress of commercial interests. Said one doctor: ``You can't run health care as a business, otherwise people will regard us not as professionals but as traders.''