Recently, Union Health and Family Welfare Ministry issued draft Clinical Establishment (Central Government) Second Amendment Rules, 2019 (the 'Amendment Rules') on 18 march 2019 enforcing changes in the human resource at small diagnostic laboratories in the existing pathology laboratory rules.2
Key Points of the amendment:-
The existing Clinical Establishments (Central Government) Amendment Rules, 2018 (the 'Rules') do not mention the qualification of authorized signatory at basic composite laboratories; hence, the amendment made in the Rules has covered the following points:
- After entries relating to serial No 1 of schedule of Clinical Establishment Rule 2018, which states that test can be performed in mobile laboratory at field locations also. Now the following note should be inserted "Medical test should normally be undertaken on the advice of a doctor".
- At serial No 3 of schedule of
Clinical Establishment Rule 2018 which states about the
Minimum qualification of Technical Head of Laboratory or Specialist
or Authorized Signatories the following note should be
inserted
- In column two for "the word the authorized signatory will be liable for authenticity of laboratory test report" the word "the authorized signatory will be liable for authenticity of laboratory test report only" shall be substituted.
- In column three for the word "Wherever interpretation of lab results or opinion there on are required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential", the words "Interpretation of lab results or opinion there on when required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential" shall be substituted.
The amendment added the special instruction regarding the medical laboratories and their authorization status along with the need of the medical practitioner for checking the authenticity of the Report.
Reported draft notification on revised Rules is based on recommendations of a panel set up by the ministry on August 04, 2018. The panel comprised of principal scientific advisor to government of India as chairman, secretary (health), secretary (health research) and secretary (biotechnology) as members.
Conclusion:
The current amendment provides the proper guideline for the laboratories performing the test and have all the rules and regulation which helps to check the authenticity of the report. Along with this the new amendment emphasizes that report or the lab test should be done under the proper guidance of the medical practitioner.
Footnote
2 https://mohfw.gov.in/eventsandannouncements/draft-notification-regarding-clinical-establishment-central-government-second
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