Centre plans overhaul of labs with strict sample collection, transport rules

The Directorate General of Health Services (DGHS) is set to notify rules mandating minimum standards for medical sample collection and transportation to prevent compromise or contamination that could lead to inaccurate test results, according to documents reviewed by Mint and officials familiar with the matter.

The new standards to be notified shortly are aimed at addressing the regulatory gap that has led to compromised sample integrity and result inconsistencies, particularly in the growing home-collection sector. The proposed standards following the Delhi High Court directive will ensure that all samples, including blood, urine, and swabs, are handled by trained professionals and transported under proper conditions, including maintaining a cold chain. The development assumes significance for India’s $13 billion diagnostic industry and will provide them with an uniform and legally-binding framework.

Standards important

According to diagnostic industry experts, the proposed standards are important due to a surge in home sample collection services and a widespread lack of consistency in how medical samples are collected, stored, and transported. The Covid pandemic accelerated the demand for home testing, leading to the rapid establishment of numerous new laboratories. While this expanded access to testing, it also brought a new set of challenges, as many of these facilities were set up with low-end equipment and operated on extremely slim profit margins. As a result, they often struggled to attract good talent or invest in advanced equipment for specialized tests. This has led to inadequate quality standards, with reports being generated without necessary checks and balances.

“The new policy’s primary impact will be felt by patients and the general public. It will ensure that all diagnostic samples, whether blood, urine, or swabs, are collected by trained professionals following strict protocols. This includes the mandatory use of personal protective equipment (PPE), proper labelling to prevent mix-ups, and a meticulous triple-packaging system to prevent leaks and biohazards during transport,” said the first official cited earlier.

Step to reliability

The standardisation is a crucial step towards improving the reliability of test results, which directly leads to more accurate diagnoses and effective treatment plans, said the second official.

The Delhi High Court in its 11 November 2022 order said that there is no law or regulation governing how diagnostic samples are collected, stored, and transported, and directed the government to frame and notify minimum standards for the same.

The second official added that for healthcare professionals, the guidelines provide a clear and uniform framework. “Pathologists, technicians, and collection agents will now have a legal standard to adhere to, which will not only streamline their work but also minimize the risk of sample degradation and contamination, ” this official said.

The policy will mandate proper storage conditions and set clear timelines for transport, which is especially vital for vulnerable or high-risk patients. This initiative provides a basis for accountability, ensuring that all clinical establishments operate with the highest degree of professionalism and safety. It will serve as a powerful tool to enforce quality control across the diagnostic landscape, raising the bar for the entire industry, the official added.

Queries emailed to the health ministry on Tuesday remained unanswered.

Move welcomed

Medical experts welcomed the move, saying that that improper handling, especially a lack of a proper cold chain in a country with India’s often-harsh climate, can severely compromise samples and distort test results. Such inaccuracies can lead to wrong diagnoses, inappropriate treatment, and a significant erosion of public trust in the healthcare system.

Dr. Sunita Kapoor, director and laboratory head at City X-ray & Scan Clinic, said that the new policy will require an initial financial investment from diagnostic companies. This investment will cover essential areas such as staff training, equipment upgrades, cold chain management, and quality control processes.

However, she emphasized that despite this upfront expenditure, the long-term benefits will outweigh the initial costs. She believes that these investments will lead to long-term savings by improving efficiency and reducing operational inefficiencies, such as the need for re-tests.

Dr. Kapoor said that a rise in expenditure for diagnostic centres will lead to a small increase in test costs for patients. Over time, the focus on quality and standardization will not only improve patient care but also ensure affordability, making reliable diagnostics accessible to more people. She argues that this approach will ultimately lower overall expenses, enhance trust, and ensure the sustainable growth of the industry without a significant and lasting increase in costs for patients.

‘Timely and commendable’

Dr. Arun Dang, chief executive officer of Dr. Dangs Lab, called the initiative “timely and commendable.” He emphasized that the absence of uniform standards has been a critical gap, and since most diagnostic errors occur in the pre-analytical phase, these guidelines will help safeguard sample integrity and ensure reliable results. He described the proposed policy as a “decisive step toward quality, accountability, and better patient care.”

International standards for medical sample collection and transport are well-established. The World Health Organization (WHO) provides guidelines for the safe transport of infectious substances, while the US-based Clinical and Laboratory Standards Institute (CLSI) offers detailed guidance for the pre-analytical phase of testing. Countries like the US and those in the European Union have their own stringent regulations to ensure sample integrity and patient safety.

Similarly, Dr. Shelly Mahajan, lab director at Mahajan Imaging & Labs, highlighted that while the rapid growth of the diagnostics sector has improved access, it has also “revealed serious gaps in regulation and standardization.” She noted that even the most advanced laboratory cannot deliver accurate results if the sample it receives is compromised. The new policy will bring much-needed uniformity and strengthen trust in diagnostic outcomes across India’s healthcare ecosystem.