Clinical laboratory registration: Is it a practical approach?

Dr Rakesh Sharma

It is heartening to note that Delhi government has taken an initiative and drafted the Delhi Diagnostic Centres and Labora-tories Registration (DDCLR). The final draft of DDCLR was discussed with representatives of medical profession and administration recently in a meeting presided by the Minister of Health, government of Delhi. Administration has done a remarkable job by framing a bill to check mushrooming of clinical laboratories run by unqualified persons. If implemented the Act will definitely improve clinical laboratory testing in the state.

I am slightly skeptical about the fate of the bill. Way back in the nineties, Delhi government introduced an anti quackery bill. The purpose was to check unqualified personnel practicing medicine. But it could not be implemented by the assembly as our elected representatives thought that quacks outnumber qualified medical personnel. The interests of majority are supreme in great Indian democracy. They were of the view that though unqualified quacks are providing cheap medical facility to the poor and downtrodden, they should be rehabilitated first.

Types of establishments involved in analysis of human specimen

1.Independent labs are invariably managed or owned by qualified pathologists. Since they are professionally managed, results are undoubtedly the best. Pathologist, who along with their qualification is registered with DMC, MCI or SMC authenticates results.

Suggestion: Since they are registered with Medical Council they should not come under the purview of DDCLR.

2.Labs in NH and ME: Such labs are situated in hospitals, nursing homes and big medical establishments. They perform tests under direct supervision of pathologist during routine hours. However, technicians perform tests in emergency. However a pathologist authenticates results performed in emergency the next day. These establishments are registered with DHS. Authorised signatories pathologists are registered with DMC, MCI or SMC.

Suggestion: Since establishment and authorised signatory, both of them are registered with authorities they should not come under purview of DDCLR.

3. Small labs in clinic of GPs: Lab technicians or GPs themselves perform tests in such labs and GPs authenticate results. They usually perform routine tests that help in diagnosis of their own patients. GP is registered with DMC, MCI and SMC.

Suggestion: List of tests performed by them should be defined. This should include tests required for immediate diagnosis and do not require special training. A few such tests are haemoglobin, TLC, DLC, ESR, Urine R/E Stool R/E, Blood Glucose instant and pregnancy test.

4. SCCs in NH and ME: Specimen are collected under hospital supervision and transported to independent labs for analysis. NH and MEs are responsible for collection and transportation of the specimen and labs are responsible for results. Since establishment and authorised signatory, both of them are registered with authorities they should not come under purview of DDCLR. However since 75 per cent cause of wrong results are pre analytical i.e. collection, labeling and transportation, strict guidelines for specimen collection and transportation should be framed and implemented.

Suggestion: Registration along with NH and ME registration suggested. Specimen collection guidelines must be prepared and strictly followed.

5. SCCs in non medical establishments: Specimen are not collected under medical supervision and transported to independent labs for analysis. There is no registering authority or responsible person involved.

Suggestion: They should be banned with an office order from DHS.

6. Independent labs run by unqualified persons: Labs perform tests under by unskilled staff. Reports are released by unqualified persons. There is no registering body.

Suggestion: Should be banned with an office order from DHS

Conclusion

1. Clinical laboratories including specimen collection centers are medical establishments.

2. Medical councils have powers to take action against persons registered with them only.

3. Only persons registered with DMC, MCI or SMC should be allowed to establish and run them.

4. Director of Health Services (DHS) should issue orders banning all activities carried out by non-medical personnel, which are obviously not registered with medical councils.

5. There is no need of any Act because it will have fate similar to anti quackery bill.

6. Pathologists are medical graduate with special postgraduate training in pathology and clinical laboratory testing. If specialists of other fields performing delicate operations and activities including invasive techniques are not regulated, why should pathologists require separate legislation?

The writer is president, Association of Practising Pathologists