Past imperfect, future for us to see

I have been practicing pathology for the last 40 years and things obviously have not been the same in the last four decades. Technical development and changes in commercial perspectives have solved some problems but have thrown open more challenges.

We have come a long way since then; some problems have been solved but many more have emerged. I will try and categorize these and give brief outline of each issue as I see it.

• Automation and quality assurances;
• Corporate takeover of the industry and price wars; and
• Aggregators and sample handling

Automation and quality assurance
In the last three decades, relentless and dedicated efforts by NABL have seen a sea change in quality assurance of many clinical laboratories, where well-designed protocols are in place. Technological advancements have been rapid, with the result that most equipment have very high level of precision. This has led to narrowing of permitted range, which can at times be very vexing because nature allows much wider normal ranges, and the treatment protocols are based on them. Therefore, dealing with accepted statistical protocols proves to be self-defeating at times almost like the efforts of Sisyphus.

The global quality standards for clinical laboratories have evolved and changed several times, and most of the standards have so far been prescriptive in nature, which means that though the labs had to strictly follow well defined norms the results were by and large satisfactory. However, with increase in maturity of labs’ quality practices globally, the standard has also become flexible. The recent version ceases to be prescriptive and has given lot of flexibility to labs. Wether Indian labs will be able to live up to the expectation remains to be seen. Only a small percentage of Indian labs have opted for accreditation so far.

Government has made lot of efforts in implementing the Clinical Establishments Act across the country; however, it still has a lot of scope for improvement. CE requirements must incorporate quality assurance measures.

Corporate takeover of the industry and price wars
The business of running labs has been taken over by big investors, and are managed and controlled by business managers, who may not have been exposed to the nuances of medical services. Industry corporates must ensure that the managers are trained to have empathy for the end-users of the services they provide. It is common sense logic that large-scale operation leads to more profits and, therefore, the tendency is to aggregate samples in either regional or central labs, which has its own drawbacks like increased TAT and sample deterioration. As the magnitude of operations increases, the need to strike a balance between patient’s needs and business concerns becomes very important, where the tilt must be toward patient’s welfare and not toward business. The ethical standards and maturity of all companies is not the same; therefore, some regulatory indicators and check points must be in place, and these should be honestly monitored.

Every other player in the market is armed with huge armamentarium of tests, identical equipment, manpower, and accreditations. So, what makes one stand out from the other? The only visible solution is price war in B2B segment offering unviable discounts and commodification of lab tests, offering packages at ridiculous prices to the B2C segment. The social media, the print, and the television media are full of such advertisements enticing people to undergo tests they do not need. Government must step in with regulatory measures to stop the price wars.

The result of such price cuts is bound to affect profits and dividends, and that is very worrying because cutting corners is bound to affect quality badly. Again, we must look up to the regulators to prevent deterioration of quality by incorporating some check points in these operations.

Aggregators and sample handling
Educated version of the line men who get the tests done from the labs, which give them maximum discounts, sometimes going up 70 percent or more on the MRP. these line men have evolved. They call themselves aggregators, speak English, wear business clothes, and work on Excel. These aggregators collect samples from local collectors and submit to one or more of the big players.

This entire activity is not regulated, and consequently very little attention is paid to quality issues. Government intervention is badly required to control or maybe curb such activities.

Views are personal.