Newspapers in this populous nation regularly publish stories about clinical laboratories that produce inaccurate lab test results that cause patient harm

In the healthcare systems of many countries across the globe, one common issue involves the accuracy and reliability of medical laboratory test results produced by clinical pathology laboratories. In most of these countries, a lack of effective government regulation is a primary reason why shady lab operators continue to provide questionable lab test results to patients.

In India, professionally-trained pathologists and laboratory scientists have repeatedly called for tougher government regulation of medical laboratories, along with more diligent inspections and enforcement actions by the authorities. Newspapers in India regularly publish stories of the medical lab enforcement actions that do happen.

Crackdown on Pathologist Fraud in Mumbai

For example, in July 2015, five pathologists were given notices by the Maharashtra Medical Council (MMC) in Mumbai for “signing reports at about 15 laboratories while a pathologist was present only at one” according to a report in the Mumbai Mirror. The report states, “This is the first time that the MMC has taken any action to deter pathologists from indulging in such practices.”

And then, on September 28, 2105, Pharmabiz.com reported that the licenses of those five pathologists would be suspended. In this instance, it was complaints from qualified professionals that spurred the action.

Such incidents is causing the public and professionally-trained pathologists to put increased pressure on the Indian government to exercise greater oversight on the operation of clinical laboratories in India. Organizations such as the MMC, which is a “statutory body, established by the law of the state,” are working to improve the operation of pathology labs by following up on complaints and issuing notices and/or fines when necessary.

How Different Countries Use the Term ‘Pathology Laboratory’

In India, as is true of many other countries, a pathology laboratory is generally used to describe what is called a clinical laboratory in the United States. These labs typically are testing bodily fluids, such as blood, urine, and saliva. Histopathology laboratories are the organizations that test tissues and these labs are commonly called pathology labs in the United States.

However, in other locales, such as the various countries of the Commonwealth of Nations, pathology has a narrower meaning: “The laboratory analysis of bodily fluids, such as blood, urine, and tissue homogenates or extracts.” This is closer to what is referred to as “clinical pathology” in the U.S., while histopathology is used to describe anatomic or surgical pathology.

Lack of Effective Medical Laboratory Regulation

In addition to the differences in the common uses of the words to describe the types of testing that goes on in a pathology lab, there are sometimes major differences in how those labs are regulated. For many years, qualified, professional pathologists have been calling for greater oversight and regulation of the labs in India. (See Dark Daily, “Pathologists and Medical Laboratory Scientists in India Call for Active Government Regulation in Response to Ongoing Problems with Quality of Medical Laboratory Tests,” May 30, 2014.)

The number of pathology labs in the state of Maharashtra, India, has been growing for the last several years. In an article published on the English broadsheet daily news site dna, Rajiv Rao, MD, Laboratory Director at D.Y. Patil Hospital and Research Centre in Mumbai and an executive council member of the Maharashtra Association of Practicing Pathologists and Microbiologists (MAPPM), stated that “anyone can open a pathology laboratory in this [state]. The person has to acquire a Shops and Establishments License from the municipal corporation and show that they have a pathologist on the rolls. However, the state government does not carry out due diligence to ensure that a qualified pathologist is present at all times to sign reports.”

Rajiv Rao, MD, is Laboratory Director at D.Y. Patil Hospital and Research Centre in Mumbai and a spokesperson for the MAPPM, an organization working for more regulation and oversight of pathology labs in Maharashtra, India. (Photo copyright: LinkedIn.)

Rajiv Rao, MD, is Laboratory Director at D.Y. Patil Hospital and Research Centre in Mumbai and a spokesperson for the MAPPM, an organization working for more regulation and oversight of pathology labs in Maharashtra, India. (Photo copyright: LinkedIn.)

There are more than 5,000 labs in Maharashtra alone, and of those, an estimated 1,000 are in the city of Mumbai. The President of MAPPM, Sandeep Yadav, MD, cites two particular problems: “One is non-pathology people running laboratories and issuing reports, and the second is pathologists simply renting their signatures without being present.”

Too Many Pathology Labs and Too Few Professional Pathologists

The number of pathology labs means that there are simply not enough qualified, trained professional pathologists to staff them all. The news site Nagpur Today reported in December of 2012 that “there is a stark need of MD pathologists.” The situation has not improved in the intervening years.

Another problem that appears to be all too common is that of doctors or hospitals “forcing patients to purchase medicine at selected shops and undergo tests at certain pathology labs”. In Indore, the district administration issued a prohibitory order in an attempt to curb such practices.

Mistakes at Pathology Laboratories Can Lead to Tragedy for Patients

Mistakes at pathology labs can result in tragedy. There have been several stories in recent years about people who suffered due to inaccurate pathology lab reports. In 2006, a man committed suicide after a pathology lab incorrectly informed him that he was HIV positive. In that instance, the lab technician was later sentenced to five years in jail and fined. The Times of India reported that “the court held Mahesh Wadnerkar, a diploma holder in medical laboratory technology, guilty for the suicide of Nandakishore Ghorpade who hanged himself after consuming insecticide on March 8, 2006.”

Fake Pathology Lab Running for Seven Years

Even worse are examples of medical labs in India that appear to be real but are actually fake and using forged signatures of real pathologists. Just such a lab was recently closed down and its owner, a 40-year old former lab apprentice, was charged with defrauding hundreds of people.

Operated in South Delhi near the All India Institute of Medical Services (AIIMS) and Safdarjung Hospital, the lab generated hundreds of reports each day for seven years until Anu Kundra, MD, discovered that her signature was on the fake reports. “I was shocked … I sent an employee to the lab to get his blood group tested. When he got the report, it had my signature,” Kundra stated in a Hindustan Times article.

Pressuring Authorities to Take Action and Improve Regulation of Pathology Labs

Professionally-trained pathologists in Maharashtra state point out that continuing pressure from both the public and professional associations will be necessary to make real, lasting change in how pathology labs are run and regulated in Maharashtra and throughout the country. Another way to improve the situation is for doctors to refuse to blindly accept lab test reports, for more patients to demand to see qualifications of the pathology labs, and for medical associations to push for more government oversight. If not, illegally-operated pathology labs will continue to operate, thus putting the health and safety of patients at risk.

—Dava Stewart

Related Information:

Shortage of qualified Pathologists in Vidarbha

Referring medicine shops & pathology labs by doctors banned in Indore 

Lab technician gets jail for ‘declaring’ man HIV+ 

Crackdown Begins on Pathologists Over Wrong Diagnostic Test Reports 

Maharashtra Medical Council to suspend licenses of 5 path labs in state for unethical practices

Pathologists and Medical Laboratory Scientists in India Call for Active Government Regulation in Response to Ongoing Problems with Quality of Medical Laboratory Tests  

Fake Path Lab Near AIIMS Forged Signs, Made Reports Out of Thin Air

The Economic Times: The Next Precipice: Medical Labs in India (PDF)