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Above: Medical tests must not be looked at in isolation but as a yardstick/Photo: UNI

The amendments in Clinical Establishments Second Amendment Rules, 2019 are aimed at ensuring that patients are not conned into undergoing costly tests and diagnosis that may be totally unwarranted

By Dr KK Aggarwal

The Clinical Establishments (Registration and Regulation) Act, 2010, was enacted by the central government to provide for registration and regulation of all clinical establishments in the country with a view to prescribing the minimum standards of facilities and services provided by them. On March 1, 2019, the ministry of health issued another notification that lists certain rules for further amendments in the sector.

Called the Clinical Establishments (Central Government) Second Amendment Rules, 2019, its highlights are:

  • In the Clinical Establishments (Central Government) Rules, 2012, in the Schedule in Table-(i) after the entries relating to S No I, at the end, the following notes shall be inserted, namely, “Note (i). Medical tests should normally be undertaken on the advice of a doctor.”
  • In Column 2, for the words “The authorized signatory will be liable for authenticity of laboratory test report”, the words “The authorized signatory will be liable for authenticity of laboratory test report only” shall be substituted.
  • In Column 3, for the words “wherever interpretation of lab results or opinion thereon are required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential”, the words “interpretation of lab results or opinion thereon when required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential” shall be substituted.

As far as the legal implications of the amended rules are concerned, the first which states that “Medical tests should normally be undertaken on the advice of a doctor” can be interpreted as follows:

  • Medical Tests: The tests include pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, and are usually carried on with the aid of laboratory or other medical equipment.
  • The usage of the phrase “should normally be undertaken” rather than “shall normally be undertaken” makes the directive non-mandatory. It’s only an advisory, that too in normal circumstances.
  • Advice of a doctor: Doctor under the Clinical Establishments Act means an MBBS doctor. But, in Dr Mukhtiar Chand & Ors vs State of Punjab & Ors decided on October 8, 1998, the apex court said: “In our view, all that the definition of ‘Indian Medicine’ and the clarifications issued by the Central Council enable such practitioners of Indian medicine is to make use of modern advances in various sciences such as Radiology Report (x-ray), complete blood picture report, lipids report, ECG, etc. for purposes of practising in their own system.”

Now coming to the second amended rule which states that “The authorized signatory will be liable for authenticity of laboratory test report only”, it must be noted that the Clinical Establishments Act also prescribes the minimum qualification of Technical Head of Laboratory or Specialist or Authorised Signatories and says that presence of an MBBS doctor is desirable in small laboratories. This means that non-MBBS technical staff can also be hired but only for the purpose of signature and verification of the report and not its interpretation.

The third amended rule states that “Interpretation of lab results or opinion thereon when required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential” meaning that the presence of an MBBS doctor is a must.

So, for the purpose of clinical establishments, the role of an MBBS doctor or above is most important when it comes to the question of running a laboratory. Yet, the fact remains that today doctors find themselves in the middle of a crossfire and are blamed for both under and over investigation.

In a Supreme Court judgment in the Martin F D’Souza vs Mohd Ishfaq case, Justices Markandey Katju and GS Singhvi had on February 17, 2009, enlisted six precautions which doctors/ hospitals/nursing homes should take. Two of them were related to investigations. Firstly, no prescription should ordinarily be given without actual examination. The tendency to give prescriptions over the telephone, except in an acute emergency, should be avoided. Secondly, a doctor should not merely go by the version of the patient regarding his symptoms, but should also make his own analysis including tests and investigations where necessary.

Medical tests require proper interpretation. A doctor looks at test results not in isolation but as a yardstick for treating the patient. It must be kept in mind that: (1) Lab results can turn out to be both false positive and false negative; (2)  Variations in lab test results need to be interpreted clinically; (3) Comparisons and fluctuations vis-à-vis previous reports is of utmost importance; (4) Most important is when not to do investigations. The fashion of “all test panels” are neither necessary nor in the interest of the patient; (5) Most tests usually aren’t helpful for low-risk surgery. The tests themselves are very safe, but they can cause false alarms. This can lead to anxiety and more tests adding to the cost.

Like over-the-counter (OTC) drugs which patients self-prescribe, there are OTC tests also. A classic example is the urine test for determination of pregnancy. Now the government is thinking of making HIV self-testing, where a person collects his or her own specimen (oral fluid or blood) and then performs an HIV test and interprets the result, often in a private setting, either alone or with someone he or she trusts. In 2016, the WHO published the first global guidelines on HIV self-testing.

Another field is direct-to-consumer testing. Most of the time, genetic testing is done through doctors. In direct-to-consumer genetic testing, the tests are marketed directly to customers via television, print advertisements, or the internet, and the tests can be bought online or in stores. Customers send the company a DNA sample and receive their results directly from a secure website or in a written report. Direct-to-consumer genetic testing provides people access to their genetic information without necessarily involving a doctor.

Home monitoring of blood pressure is another acceptable evidence-based testing. Apart from that, these days home inpatient care and ambulance pre-hospital emergent care is also making a dent in healthcare where primary care is done by technicians and nurses. Even in proposed wellness centres under Ayushman Bharat, the government is planning to post non-MBBS healthcare providers. All ASHA workers today are allowed to do primary investigations like malaria testing, tuberculosis testing, pregnancy testing, etc, under the National Health Programs. The Indian Council for Medical Research is soon coming out with a National List of Essential Investigations (NLEI).

A combination of self-testing OTC investigations and NLEI may just be the right mix to stop hospitals and diagnostic labs from pitching preventive health packages that a patient might not need but is often pressured into buying.

—The author is President, Heart Care Foundation of India, and President-elect, Confederation of Medical Association of Asia and Oceania

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