Friday, August 11, 2017

who should sign diagnostic laboratory reports?

Why is signing a test report such a big deal? People should be asking different kinds of questions. Are these diagnostic laboratories standard? Do they perform rigorous quality checks? Do they have SOPs? Are their instruments calibrated? Are their technicians trained?  Are these laboratories accredited? Are their reports reliable? These questions are more meaningful. Somehow, in the war of misplaced prejudices and priorities, the right questions have been ignored.

Which are the types of Laboratories?
Laboratory tests provide useful parameters that aid clinicians diagnose and treat their patients appropriately. As tests provide measurable evidence, they are the part of evidence based medicine, unlike where a clinician makes the diagnosis based on hunch or personal experience. There are a variety of tests, some basic and some advanced. Some are used to assess health and some to diagnose diseases. Some tests need simple tools whereas few others are complicated and expensive. Some tests can be carried out by laboratory technicians but few require specially trained technologists. Some establishments are mere laboratories while some are diagnostic centers, which encompass wide-ranging tests. These laboratories could either be attached to the hospitals or function standalone as private (community) establishments. Health ministry has classified laboratories as small, medium and advanced depending on the complexity of the services provided by them. These clinical laboratories are also termed as pathological labs.

What is the current market like?
As per some estimates, diagnostics in India is $5-billion industry that is growing at an annual rate of 15-16%. There are no official figures on the exact numbers of diagnostic laboratories or diagnostic centers but estimates suggest that there are over one lakh diagnostic laboratories. Of these, 70% are pathology laboratories and the rest offer radiological services. Despite the presence of dominant corporate players, the diagnostic industry is still fragmented by unorganized players to the extent of 90%.

Laws on regulation of diagnostic laboratories
The union health ministry introduced the Clinical Establishments (Registration and Regulation) Act, 2010 to register and regulate of all clinical establishments in the country. Health is a state subject and therefore is not binding on all the states. Currently, this act is applicable at ten states (Assam, Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Rajasthan, Himachal Pradesh, Mizoram, Arunachal Pradesh & Sikkim) and union territories.  West Bengal, Maharashtra, Andhra Pradesh (erstwhile), Odisha, Delhi, Manipur, Nagaland, Madhya Pradesh and Punjab, Chattisgarh, Haryana, Jammu and Kashmir, Meghalaya, Tamil Nadu and Tripura have their own acts. States of Gujarat, Kerala and Goa have neither adopted the central Act nor have their own Act. Despite being adopted or passed, the Acts are not operational in all the states. 

Role of independent accreditation
In the absence of legal framework, many laboratories have voluntarily sought accreditations from the organizations like the National Accreditation Board for Testing and Calibration Laboratories (NABL) and the College of American Pathologists (CAP). Estimates suggest that about only 1% of laboratories are currently accredited. Accreditation ensures that proper quality and standard in terms of equipment and manpower are maintained. These agencies have their own regulatory board and guidelines, which inspect laboratories and award certification when these are met.

Manpower in the laboratories
In the diagnostic laboratories, the many tests are performed by semi- or fully-automated machines and are manned by qualified technicians who have diploma, graduate or postgraduate degree in Medical Laboratory Technology (MLT). Some states have their own para-medical council, which regulate these courses and register technicians. The central government too is mulling introduction of Allied and Healthcare Professional's Central Council Bill and is in consultation with the states.

The big question now being raised is: who should certify these tests? 
Most of the tests in Biochemistry are automated; the roles of technicians is restricted to collection of specimen from the patient, loading the instruments and printing reports. These instruments are periodically calibrated and subjected to rigorous quality controls by the Quality Control managers. Often, these reports contain normal (expected) range of values and are ready to be sent to the consulting physician for interpretation. The role of the biochemist is restricted to ensure the validity of the procedure and accuracy of the test results. Final interpretation always rests with the doctors, who will utilize the knowledge in the values provided by the test to make appropriate diagnosis and for further patient management. The Microbiology division includes serology/immunology and microbial cultures. The former investigations are usually simple whereas the latter needs some interpretation by the Microbiologist before being sent to the physician. Similarly, a qualified Pathologist interprets tests related to hematology, cytopathology etc and dispatches the result to the surgeon or physician.

It is therefore clear that Biochemists, Microbiologists and Pathologists are consultants in the diagnostic laboratories who can certify the test results. This brings us the next question: What are their qualifications and who prescribes them?

Qualifications as per NABL
In its guidelines (document 112), the NABL had recognized a variety of academic qualifications comprising of MBBS, DCP (Diploma in Clinical Pathology), MD/DNB, M.Sc, and Ph.D for signatory roles in diagnostic laboratories. NABL has claimed that it certifies signatory roles based on its assessment of person's competency and doesn't rely on the qualification alone. NABL had been under pressure to exclude non-doctors with M.Sc and Ph.D qualifications from all roles. Even the union health ministry questioned NABL's guidelines and reminded it to stick with CEA guidelines. Under duress, NABL sought MCI's opinion.

What is the role of MCI?
Medical Council of India has been set up to establish uniform standards of medical education, recognition of medical qualifications and registration of doctors. It has no jurisdiction over private hospitals, nursing home or diagnostic laboratories. Yet, it took upon itself the authority to prescribe qualification for signing laboratory reports. After a delay of three years, MCI replied back to NABL stating that only persons (doctors) registered with MCI or state medical councils must sign/countersign laboratory tests. In the Executive Committee Meeting of the MCI held on January 31, 2005, the members of the Adhoc Committee appointed by the Supreme Court and members of the Executive Committee of the MCI had approved the decision of the Ethics Committee that M.Sc. (Medical Biochemistry) with or without Ph.D is entitled to independently or solely sign a Medical Biochemistry report in a clinical laboratory. In a bizarre U-turn, the Executive Committee of the MCI has claimed on April 2017, that it did not approve the recommendations of the Ethics Committee. Following massive protests, NABL decided to overlook the MCI's recommendation and reverted to its original guidelines adding that local rules/acts will supersede its guidelines, wherever applicable. Therefore, it is clear that the ultimate authority to decide who should sign laboratory test reports lies in the guidelines of the state or centrally enacted Clinical Establishments Act. In the meeting of the National Council for Clinical Establishments held on 31 October 2012, it was decided that even medical colleges would come under its ambit. When the guidelines of CEA become operational, they would be applicable only in the states where the central act would be applicable.

Let us now examine each of the degrees that can enable to render professional services in the diagnostic laboratories. 

MBBS is a graduate degree, where a medical student learns about Biochemistry in the first year (phase 1) and Microbiology and Pathology in the second year (phase 2). The understanding of the utilities of diagnostic tests are basic in this course, therefore a doctor with MBBS is suitable only for basic tests. The fact that there are postgraduate courses in Biochemistry, Microbiology and Pathology itself indicates that these are specialist courses, which require understanding at a higher level.

DCP is a two-year diploma course for doctors whose curriculum includes mostly pathology and little of Biochemistry and Microbiology. If this diploma is deemed suitable for all pathological tests, there would not have been any necessity for PG courses in Microbiology and Biochemistry. Therefore, a DCP holder is not a master of Biochemistry, Microbiology or even Pathology. 

Doctors who undertake PG courses leading to MD/DNB in Biochemistry, Microbiology or Pathology are the true specialists who have the complete understanding of the subjects at a higher level. It must be emphasized here that a doctor with MD in Pathology should not be construed as a master of all pathological tests. Even though the syllabus of MD pathology includes Biochemistry and Microbiology, it is no match for the knowledge acquired by those pursuing MD in Biochemistry or Microbiology.

This brings us the final qualification- M.Sc/Ph.D, which are often taken up by non-doctors (biomedical scientists). M.Sc in Biochemistry and Microbiology are postgraduate courses similar to that of MD courses. In medical colleges, these three-year courses are termed "medical M.Sc" and are offered under the faculty of medicine to science graduates. Long ago, medical M.Sc courses were included in the first schedule of the Indian Medical Council Act 1956, which were discreetly disowned by the MCI. In medical colleges, the medical M.Sc and MD courses are conducted parallelly by the same department using the same teachers and resources (hospital and laboratory). Like their counterparts, medical M.Sc students are imparted training in the principles and practice of diagnostic laboratory. These students also study about the disease process, specimen collection, standardization of test, quality control, and interpretation of tests at the same level as MD students do. Although their graduate degrees are different, their postgraduate degree are qualitatively similar. The proficiency to render services comes from the knowledge and skills attained in the postgraduate course, not graduate course.

Ph.D is the outcome of research performed on a small area of interest. As not all Ph.D are undertaken in the field of diagnostic medicine, it doesn't confer additional knowledge or skill involved in routine laboratory investigations. Ph.D may be helpful if the research involves usage of a particular diagnostic test as a tool in the study. 

CEA guidelines
This brings us back to the guidelines of the Clinical Establishments Act. In 2012, the National Council for Clinical Establishments brought out its guidelines. In 2014, it sought feedback on the guidelines for diagnostic laboratories, which equated medical M.Sc degree holders with laboratory technicians suitable for performing tests and operating equipment. Following the widespread protest, instead of accommodating medical M.Sc qualification, it was altogether removed from roles. Following persistent protests, the ministry came forth with a new draft guidelines for diagnostic laboratories, which too denied all roles for the medical M.Sc degree holders. These guidelines are now being reviewed by the health ministry.

Role of Biomedical Scientists
The obvious question being asked is why biomedical scientists are being denied roles in diagnostic laboratories. This is based on two assumptions; one that all matters related to healthcare are the sole domain of doctors and the second that Indian Medical Council Act prohibits non-doctors from practicing medicine. Both of these are assumptions because, healthcare doesn't belong to any one group of professionals; it is complemented and participated by both medical and para-medical specialties. Lack of clinical exposure among the medical M.Sc persons is not a tenable argument as they don’t seek to examine patients or practice medicine. The other misconception being the consideration of laboratory service as a practice of medicine. The health ministry is deliberately misconstruing the clauses in the sub-section 2 of the Section 15 of the Indian Medical Council Act, which states that only registered doctors should sign or authenticate a medical or fitness certificate or any other certificate required by any law. This is being unscrupulously extended to laboratory reports. The process of examining the patient, using the information contained in the laboratory report and treating the patient is the practice of medicine; signing the laboratory test report is not.

Why are the policymakers wrong?
The policy makers must evaluate the possible outcomes of their prejudiced and biased policies. One can't take away years of experience and proficiency in the subject by a stroke of rule. There are thousands of biomedical scientists rendering their valuable services in laboratories since decades, how can they be disqualified overnight despite the possession of apt academic qualifications? Thousands could be rendered jobless due to a partisan guideline. It makes no sense to skill individuals and then deny them to practice those skills. Given that the doctor to patient ratio in India is measly 1:1674, how can the policy makers expect more doctors to be available just to sign laboratory reports? Each year, the number of doctors specializing in Biochemistry and Microbiology is declining sharply; how can the government expect more specialists in diagnostic laboratories? If these partisan guidelines are imposed, most private laboratories will hire doctors, who would serve merely as rubber stamps, contributing nothing more than their signatures. Since there is acute shortage of specialists, one individual may deal with several laboratories thereby severely compromising the quality. These policies will pave way for increased costs to the patients and higher incidences of malpractices.

What should the policymakers do?
In many Western countries, including the US and Europe, biomedical scientists are valuable resources in diagnostic laboratories. With requisite training and experience, one could even become a laboratory director. In those countries, importance is given to training, competency assessment and certification. In India, only the degrees are given importance. Mere possession or absence of a certain degree is taken for granted as an indicator of quality in India. It is time for the policy makers to understand the role of various academic qualifications and workforce available in India and to utilize them in the needs of India's healthcare system. Biomedical scientists with medical M.Sc degree are qualified enough to compensate the lack of specialist doctors in laboratories. The policy makers must give them their due and utilize their services in India's healthcare needs.

It is not practical to assign single qualification for all the laboratory tests. Mere division of the laboratories into small, medium and advanced as in the CEA guidelines and then specify qualifications for each of them is also inappropriate. Instead, a list of tests must be specified against each degree as per their training and education. The doctors are compulsorily registered in state medical councils but the biomedical scientists engaged in professional service in laboratories have no council. Registration in a council will not only give them legitimacy but also accountability. Finally, mere possession of a degree must not be taken as an indicator of competency; training and certification must be supreme. 

Ultimately, whoever possesses the requisite training, irrespective of the degree’s nomenclature, must be eligible to sign laboratory test report.

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