Excerpts from “Detailed Study on Eradication of TB and India’s DOTS Program” as submitted in Public interest litigation filed by Dr. Raman Kakar in Delhi High Court.

Summary:

Fate of such a mammoth program has been left precariously hanging from a feeble thread – at the mercy of a solitary test and its sole performer. Are govt. labs, technicians and their reporting 100% reliable?

By itself, the sputum test detects only 48% of the sick; it does not detect pediatric, extra-pulmonary or smear negative TB. Besides, once patient’s sputum dries up, his follow up becomes speculative.

Details:

Sputum smear test is the solitary foundation & the lab technician who performs it, the program hero:

In the absence of chest X-ray, it becomes purely a sputum-based program. Sputum smear microscopy is its heart and soul; the success of the concept therefore is contingent on just one precondition – that the quality of sputum smear testing would be perfect. In chaotic field conditions in public health in India, doesn’t it sound like a utopian assumption?

1. Standard of clinical laboratories in the private sector:

A handful of labs in metropolis that meet stringent western standards are far too few and expensive and represent an exception. What is available to general public is an intricate network of dubious private labs. Any joker in India can set up a clinical laboratory. Cities and towns are littered with illegal labs run by unqualified people. It is virtually a free for all. No checks and balances; no mandatory licensing, periodic calibration or standardization. Diagnosis (and hence human life) remains at the mercy of inauthentic lab reports. Forget eliminating, government of India has yet to initiate a credible survey to assess the magnitude of the menace.

However, it is reasonably argued that the appalling state of private labs hardly concerns the national TB program, because every DOTS unit has its own sputum-testing nucleus. There are about 8000 odd designated govt. labs / microscopy centers littered all over the nation and a patient must undergo sputum tests in one of these to merit registration with the program and be entitled to free treatment.

Quite true.

But since this new program stands superimposed over and integrated with the entire pre-existing govt. health-care network, the quality of govt. labs can surely be said to directly affect and reflect program-quality.

2. Standard of labs in the government sector – civil hospitals, CHCs and PHCs – is no better, possibly worse. If one can afford a private lab, one would never possibly get his investigations done from the lab within a PHC, CHC or even a civil hospital. They are often infamous for cheap, substandard, worn-out, rusted equipment; poor maintenance; obsolete technologies and ominously, a unionist work culture. Forget villages and towns, even most of the famous hospitals in Delhi possess no NALB accreditation! Inaccurate reporting though accepted as fait accompli is considered yet a minor sin compared to the looming risk to consumers of introduction of germs of AIDS, Hepatitis B etc. through usage of poorly sterilized needles and syringes!

There are several reasons for such a sorry state of affairs. One easily correctible reason is criminal mismanagement of experts (pathologists and microbiologists) who as such happen to be in short supply.

One doesn’t have to be a genius to imagine the plight of our govt. labs and blood banks when, ominously, amateurs run most of them while experts stand exiled to alien work!

Let us take a glance over Haryana:

·        While the large civil hospital, Bhiwani runs without a Pathologist, one Dr. Aditya Swaroop Gupta (MD Pathology) works as an ordinary clinician in a nearby tiny peripheral center.

·        Dr. P.K. Jain (MD Pathology) grapples with mundane outpatient duties at Pataudi as if he were a general physician.

·        Dr. A.P.Bhatia (MD Pathology) is in charge of TB & administrative duties at CHC, Nilokheri.

·        Dr. Rajbir S. Pingalak (MD Pathology) remains engrossed in daunting administrative work in civil hospital, Yamuna Nagar.

·        Dr. Mrs. Anju Gupta (MD Pathology) performs gynaec procedures in civil hospital, Palwal.

·        Dr. Sat Narain Sharma (MD Pathology) is busy administering civil hospital, Narnaul.

·        Dr. D.P.Lochan (MD Microbiology) is the deputy chief officer (M) Ambala.

·        Dr. K.D.Sharma (MD Microbiology) is district training officer, Bhiwani.

·        Dr. Lok Vir (MD Microbiology) mans casualty of B.K.Hospital, Faridabad.

Note:

·        These are but just a few examples, as surveyed sometime in 2005 and reported in a book titled ‘The Test of Time’* (8).

·        It is suspected that it may merely be the tip of an iceberg.

·        However, it is not known whether the observation can be extrapolated to other states and union territories. The petitioner has no clue whether similar gloomy scenario prevails within govt. labs (and blood banks) of other states and union territories. But his lifelong experiences within various health-care networks and inquisitive interaction with insiders have left him cynical enough to fear that the situation may even be worse at places.

Lab technician is the hero of DOTS:

Who is a TB patient and of which category; which patient has been cured or relapsed; all the answers now come solely from sputum test. Naturally then, Lab technician is the hero. Everything depends on him – his efficiency, dedication and honesty. The entire program goes haywire if this one person happens to be unreliable.

In reality some lab technicians are neither sufficiently trained nor motivated. Hardly anybody has the time or patience to educate the patients as to how to collect a proper sputum sample, so crucial. Labeling of arriving samples is at times sloppy. Quality of the slides prepared is sometimes atrocious. Checks and balances to restrain this hero – e.g. radiography, interchange of slides between two TB Centers or strict peer review – are missing. So are incentives, competitive spirit and fear of accountability from the environment. The typical casual, laid back and unionist attitude is dangerous. Reporting is sometimes negligent or even through conjecture. Manipulation of slides or reports so as to meet the targets and tell the bosses exactly what they want to hear can’t be ruled out.

In such an environment, considerable risk of false positive or false negative reporting exists, resulting in over and under diagnosis, just what X-ray has always been blamed for.

Omission of X-ray deprives a doctor (and the system) of a chance, however slim, to cross check the veracity of sputum positive reports and to reconfirm the diagnosis. Normal chest X-rays in someone with repeated sputum positive reports could raise valid suspicions, helping to nab an errant lab technician or nail his false positive reporting. Similarly, a strongly X-ray positive symptomatic individual coming back with repeated sputum negative reports could turn the needle of suspicion towards a reckless technician.

Radiography serves as that desperately needed, even if weakly efficient tool to keep a semblance of check over lab technicians. Depending solely on sputum test is unsafe; keeping some margin of error is not a luxury but a necessity in an unreliable setting as prevails in India.

Is it wise to put all your eggs in one basket? Can a program based exclusively on sputum testing succeed unless govt. labs are first made 100% reliable?

Can the current breed of our lab technicians or their predecessors be absolved of their incompetent and negligent role in the failed erstwhile program (NTP)? It happens to be more or less the same work force practically. Only some extra training has been imparted, binocular microscopes have replaced mono-ocular ones, consumables are no more in short supply and the label has been changed – from NTP to RNTCP; does it by itself guarantee efficiency? To expect an overnight transformation is to act gullible.

Feasibility of EQA:

Despite nearly 3 years of vociferous claims about its express intentions of enforcing External Quality Assessment (EQA) for enhancing quality of sputum smear microscopy work; the government has practically failed to implement it till date (June 2006).

A Sonipat study* (9) found:

·        Sputum examination guidelines violated in nearly 90%,

·        In 38.6% patients, diagnosis was clinched through a single sputum test (instead of the stipulated three tests).

Comptroller Auditor General (CAG)* (10) of India too observed that sputum was at times examined only once.

The litigant must however acknowledge that with the advent of RNTCP, sputum testing is progressively improving at places – especially where lab technician performs only sputum microscopy exclusively; obviously, slogging thus, he fast turns progressively proficient. But the scenario can hardly be generalized. Yet.