The Union Health Ministry is facing questions over differences in regulatory requirements for diagnostic laboratories serving Central Government Health Scheme (CGHS) beneficiaries and those operating under the Clinical Establishments framework. The issue has drawn attention to the implementation of minimum standards for diagnostic laboratories and the stricter eligibility conditions prescribed for CGHS empanelment.
While the implementation of the Clinical Establishment Amendment Rules, 2018, has seen limited progress, CGHS empanelment guidelines require diagnostic laboratories to meet additional conditions, including accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL), full-time pathologists and quality managers.
CGHS Guidelines Prescribe Higher Eligibility Requirements
Under the CGHS empanelment guidelines, diagnostic laboratories must meet minimum patient-volume requirements depending on their location. Laboratories in Tier I cities are required to handle at least 100 patients daily, while those in Tier II and Tier III cities and northeastern states must handle a minimum of 50 patients per day.
The guidelines also specify the availability of qualified specialists, including microbiologists and radiologists, depending on the diagnostic services provided.
In addition, laboratories must have prescribed equipment, such as fully automated five-part haematology analysers, biochemistry analysers, hormone analysers and microbiology processing units.
Clinical Establishment Rules Follow a Different Framework
The Clinical Establishment Amendment Rules, 2018, classify diagnostic laboratories into three categories: basic composite, medium and advanced.
Each category has defined standards covering infrastructure, equipment, human resources, diagnostic services, record maintenance and operational procedures.
The human-resource provisions, amended in February 2020, outline qualifications for technical heads, specialists and authorised signatories.
Under these provisions, appropriately experienced MBBS graduates and certain postgraduate science-qualified professionals may perform specified roles in eligible laboratory categories.
For certain non-medical authorised signatories, laboratory reports must include a disclaimer stating that the findings are intended for use by medical practitioners and do not independently constitute a medical diagnosis.
The framework also places responsibility for report authenticity on authorised signatories and permits full-time, part-time or outsourced specialist arrangements for certain investigations.
Unlike the CGHS empanelment requirements, these rules do not universally mandate NABL accreditation, a full-time pathologist or a quality manager for every diagnostic laboratory.
Healthcare Advocates Question Differences in Patient Safeguards
Malini Aisola of the All India Drug Action Network (AIDAN) questioned why the government requires additional safeguards for laboratories serving CGHS beneficiaries while similar requirements are not universally applicable to diagnostic facilities serving the general population.
She argued that the CGHS conditions demonstrate the government’s recognition of the importance of qualified professionals, appropriate equipment, quality-control systems and external accreditation in ensuring reliable diagnostic services.
Consultant pathologist Dr Anan Jaiswal has also raised concerns over the differing requirements. In a communication to the Prime Minister’s Office, he questioned why safeguards considered necessary for CGHS beneficiaries are not applied uniformly to laboratories serving patients who pay for diagnostic services themselves.
Debate Highlights Need for Consistent Diagnostic Quality Standards
The differences between CGHS empanelment conditions and the broader Clinical Establishments framework have brought renewed attention to diagnostic laboratory regulation in India.
The concerns centre on whether existing minimum standards provide adequate safeguards for patients and whether stronger quality-assurance requirements should extend beyond laboratories empanelled under government healthcare schemes.
The debate also highlights the need for clarity on the implementation of existing regulations and the measures required to ensure reliable diagnostic services across healthcare facilities.