Professional pathologist’s organization in Maharashtra, India, demands that the government’s Directorate of Medical Education and Research intensify enforcement of laws regulating clinical pathology labs, or suspend the director for failing to comply
There are thousands more medical laboratories in India than there are certified pathologists to supervise and direct them. This is becoming a source of conflict. On one side are consumers who want quality medical laboratory testing services they can trust and government regulators who want to enforce the law. On the other side are tens of thousands of lab companies that continue to operate without certified pathologists and other trained lab scientists.
This is why India continues its struggle to provide licensed and registered clinical pathology services to its more than 1.2 billion residents amid a sea of illegal pathology clinics and a government that seems increasingly ineffectual in its ability to protect patients. Frustrations with government organizations and law enforcement has led many professional pathology and microbiology organizations to speak out.
These professional associations demand that the government work more aggressively to enforce court orders that dictate who may or may not operate medical laboratories, diagnose test results, or issue reports. The lack of enforcement, professionals argue, continues to put patients at real risk of misdiagnosis and malpractice, and casts suspicion on the entire field of clinical pathology.
For international readers of Dark Daily, in India, the term “pathology” describes a laboratory performing standard medical laboratory tests, such as chemistry, hematology, immunoassay, and microbiology. Histopathology is the term used to describe diagnostic testing that utilizes tissue specimens.
One example of a call for more government enforcement action involves the pathologist organization in Maharashtra that is now demanding an increase in raids on illegal laboratories, or suspension of the current Director of the Directorate of Medical Education and Research (DMER), Dr. Pravin Shingare, MS, for “protecting the interests of illegal laboratories.” The DMER has responded with claims that a shortage of qualified pathologists has left them no choice but to suspend government crackdowns on these illegal labs, particularly in rural areas.
MAPPM Accuses the DMER of Enabling Illegal Pathology Laboratories
According to a February 2017 article from Hindustan Times, there are more than 10,000 diagnostic laboratories in the region, but many of them are run by technicians working alone, rather than under the supervision of a registered pathologist. The Maharashtra Association of Practicing Pathologists and Microbiologists (MAPPM), which, according to their website, is “the largest body of certified pathologists in the state,” is growing increasingly concerned with the blind eye India’s government and police have towards these illegal laboratories and the very real risk they pose to patients.
MAPPM has been fighting for standardization of labs in the state for more than 10 years. In a May 2016 article from the Times of India, MAPPM president Dr. Sandeep Yadav, MD, briefly lauded the DMER, stating that it had finally “taken a commendable decision [in deciding to uphold the Bombay Court General Resolution]. Labs run by unregistered technicians [are] akin to quacks running labs and giving away crucial reports that decide the course of action of a patient’s treatment.”
However, the DMER suspended the orders created through the Medical Council Act only weeks later, according to a follow-up article from The Times of India. It also began to grant “permissions to lab technicians with a Diploma in Medical Lab Technology (DMLT) who register with the council” to run laboratories without a registered pathologist to supervise. MAPPM argues that these permissions are unethical, and detrimental to highly trained pathologists, medical professionals, and patients.
MAPPM claims that because of the lax enforcement of current regulations, lack of penalty, and lack of real restrictions, nearly anyone can set up their own pathology center without concern for accreditation or compliance, and in full defiance of the law.
MAPPM Requests Raids, or the Suspension of DMER Director
An article from the Pune Mirror reports that the MAPPM has asked DMER officials to raid these illegal medical facilities. The association’s independent drive to collect data discovered that “in certain cities and districts, labs are run by doctors who hire a mere technician for day-to-day operations of their hospital, which is against the law.”
MAPPM has independently compiled a list of hospitals, nursing homes, and healthcare facilities housing illegal laboratories, and is urging authorities to conduct raids and “sting operations” on labs and personnel who are not adhering to the law, or MCI and MMC requirements.
If the DMER fails to take the appropriate actions, MAPPM is also calling for the suspension of Director Shingare. Dr. Shingare, however, insists that his hands are tied, and that MAPPM “fails to address the issue of shortage of registered pathologists in the state.” Dr. Shingare claims that there are a mere “2,271 pathologists registered with MMC and we have a genuine crisis of manpower.” He also claims, contrary to MAPPM’s findings, that although DMLT Techs are performing the tests and running reports in many clinics, “they are not involved in giving out opinions based on the same.”
India’s professional clinical pathologists and government seem to be at an impasse that casts doubt on the quality and integrity of the lab test results from many medical laboratories. In turn, this makes it more difficult for patients to finding reliable, safe, diagnostic testing services.