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Minimum Standard of Medical Diagnostic Laboratories: Union Government notifies Clinical Establishment Rules

Meghna A SinghaniaWritten by Meghna A Singhania Published On 2019-05-23T12:07:28+05:30  |  Updated On 23 May 2019 12:07 PM IST
Minimum Standard of Medical Diagnostic Laboratories: Union Government notifies Clinical Establishment Rules
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New Delhi: The Union Health Ministry has recent issued the revised Gazette  notification, notifying the Clinical Establishments (Central Government) Amendment Rules, 2018 which lay down that Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) —


"Every clinical establishment relating to diagnosis or treatment of diseases, where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Schedule."


Medical Diagnostic Laboratories (or Pathological Laboratories) have been divided into Basic Composite (Small), Medium and Advanced. The Gazette specifies the various tests which are either essential or desired to be conducted at the said laboratories as well as the infrastructure, legal, record keeping and manpower essential for various classifications on the laboratories


The schedule attached below lays down the requirement for each type of path labs.






Scope of Services


















































































S. No.






Type of Laboratory






Basic Composite






Medium






Advanced






(1)






(2)






(3)






(4)






(5)






I






Scope of Services






These tests (as mentioned below) can be performed in mobile






laboratory locations also.




at field






In addition to the tests performed in basic composite laboratory, including tests mentioned as under.






In addition to tests performed in medium laboratory, additional tests mentioned as under.






(a) Biochemistry






Routine Biochemistry tests like Blood Sugar, Renal Function Tests, Liver Function Tests, Amylase,

Lipase, Lipid profile, Cerebro -Spinal Fluid (CSF) and other biological fluids (glucose and protein), Oral Glucose Tolerance Test, Electrolytes, Calcium or

Phosphate, HbA1c, any bio chemistry based rapid test.






Hormone Bioassay, Tumor markers, plasma protein electrophoresis






(a) coagulation profile, Drug monitoring and toxicology assay,

(b) Molecular genetics, tests for detection of inborn errors of metabolism






(b) Haematology






Haemogram, Bleeding Time, Clotting Time, Prothrombin Time, Activated Partial Thromboplastin

Time, Blood grouping and matching.






Coagulation Assay






All other Haematology tests also.






(c) Histopathology






Nil






May do, subject to availability of equipment and specialist






Histopathology Examination






(d) Molecular Genetics






Nil






May do, subject to availability of equipment and specialist






Molecular genetics






(e) Cytopathology






Nil






PAP smear, Fine Needle Aspiration Cytology(FNAC), sputum and CSF cytology






Immuno Cytochemistry. Other biological fluid cytology;
Ultrasound or CT guided FNAC.






(f) Immuno- histopathology






Nil






Nil






Immunohisto-chemistry:






(g) Medical Microbiology & Immunology






Basic tests like Rapid Test (Point of Care tests) for infection, urine routine examination and microscopy, Hanging drop for Vibrio cholerae, Stool for ova , cyst.






All HIV positive rapid assays need to be confirmed from the next level diagnostic laboratory.






(a) Serological tests for viruses, bacteria, fungi, parasites

(b) Cultural Sensitivity tests: Bacterial or fungal

(c) Other special stains besides Gram's stain.






(a) Culture sensitivity tests for viruses.

(b) Real Time Polymerase Chain Reaction (RTPCR) tests.

(c) Tissue diagnosis test for infectious diseases.




Infrastructure






Advanced






















































































































































































































II






INFRASTRUCTURE






Basic Composite






Medium






1. Signage






(a) Basic signage- A signage within or outside the facility should be made available containing the following information.






Essential






Essential






Essential






(b) Name of the person- in-charge with qualification and registration number






Essential






Essential






Essential






(c) Broad
provided
Haematology, Biochemistry,
Pathology,
Cytology,
Genetics- whichever is applicable






services i.e.






Clinical Histology, Molecular






Essential






Essential






Essential






(d) Timings of the different consultants






Desirable






Essential






Essential






(e) Internet facility or Telephone and mobile number for appointment






Desirable






Desirable






Desirable






(f) Fee structure: To be displayed separately including type of investigation and charges i.e., Special and routine tests






Essential






Essential






Essential






2. Safety Signage ( Wherever applicable)






(a) Safety hazard and caution signs -






Biomedical
segregated in coloured bins and bags as per Biomedical Waste Management Rules, 2016






including materials, chemicals,
agents,
biological material.






waste






radioactive toxic microbial infected






Essential






Essential






Essential






(b) Appropriate Fire exit signages - Minimum one fire extinguisher


Desirable



Desirable


Essential




3. Space requirement






(a) Registration and waiting room, public utilities, safe drinking





water etc.










Desirable






Essential






Essential






(b) Sample collection
area






Essential






Essential






Essential






(c) Laboratory with
adequate diffuse and spot
lighting






Essential






Essential






Essential






(d) Toilet






Essential






Essential






Essential






(e) Reporting and billing
area






Essential






Essential






Essential






(f) Staff room and
doctor's duty room - Male
and female different
where 24 hours services
available






Desirable






Desirable






Essential






(g) Washing room






Essential






Essential






Essential






(h) Preservation of the
specimens and slides






Essential






Essential






Essential






(i) Electrical facilities






Essential






Essential






Essential






(j) Temperature control
for specialized equipment
like flow cytometry and
chemiluminescence
equipment ,ELISA test
equipment etc.






Essential






Essential






Essential






(k) Counselling room for
HIV






Essential, if HIV test is
done






Essential, if HIV test is
done






Essential, if HIV test is
done






(l) FNAC room for all
patients for sample
collection






Desirable






Desirable






Desirable






(m) Dark room for
Immuno-fluorescence






Not required






Not required






Not required






(n) Frozen Section
facilities






Not applicable






Essential






Essential






4. Furniture and
fixtures






Essential






Essential as per scope of
services






Essential as per scope of
services






5.Communication
system - Telephone and
mobile number for
appointment






Desirable






Desirable






Desirable






6. Wash Basins






Essential






Essential






Essential







HUMAN RESOURCE
































(a) Minimum
qualification of
Technical Head of
Laboratory or Specialist
or *Authorised
Signatories.
*The authorised
the signatory will be liable
for the authenticity of the
laboratory test report.
Desirable: Bachelor of
Medicine and Bachelor
of Surgery (MBBS) from
a recognised university
institution.
**Where ever
interpretation of lab
results or opinion there
on are required,
registered Bachelor of
Medicine and Bachelor
of Surgery (MBBS)
the medical practitioner is essential.
Essential: Doctor of
Medicine (MD) or
Diplomate of National
Board (DNB) in
Pathology or
Biochemistry or Medical
Microbiology or
Laboratory Medicine or
Diploma in Clinical
Pathology (DCP) or
Bachelor of Medicine and
Bachelor of Surgery
(MBBS) with Doctor of
Philosophy (PhD) in any of the subjects above.
Desirable:
If any special test of other
speciality is done, it is
desirable that specialist of
that subject needs be there
on a full time or part time or
outsourced basis.
*Special tests means any
other apart from routine
basic biochemistry,
haematology, or medical
microbiology tests as
listed in basic composite
laboratory.
Illustration:
(i) Special Tests
pertaining to BioChemistry and Microbiology shall be reported
by Doctor of Medicine
(MD) or Diplomate of
National Board (DNB)
Bio-Chemistry and
Doctor of Medicine
(MD) or Diplomate of
National Board (DNB)
Microbiology
respectively.
(ii) Biopsies or Cytology
specimens has to be
reported by a person
possessing a Doctor of
Medicine (MD) or
Diplomate of National
Board (DNB) Pathology
Essential: Doctor of
Medicine (MD) or
Diplomate of National
Board (DNB) in
Pathology or
Biochemistry or
Medical Microbiology
or Laboratory Medicine
or Diploma in Clinical
Pathology (DCP) or
Bachelor of Medicine
and Bachelor of Surgery
(MBBS) with Doctor of
Philosophy (PhD) in any of the subjects
above.
Desirable:
If any special test of
other speciality is done,
it is desirable that
specialist of that subject
needs be there on full
time or part time or
outsourced basis.
*Special tests means
any other apart from
routine basic
biochemistry,
haematology, or
medical microbiology
tests as listed in basic
composite laboratory. Illustration:
(i) Special Tests
pertaining to BioChemistry and Microbiology shall be
reported by Doctor of
Medicine (MD) or
Diplomate of National
Board (DNB) BioChemistry and Doctor
of Medicine (MD) or
Diplomate of National
Board (DNB) Microbiology respectively.
(ii) Biopsies or
Cytology specimens has
to be reported by a
person possessing
Doctor of Medicine
(MD) or Diplomate of
National Board (DNB)
Pathology.
(b) Number of laboratory
technicians with Diploma
in Medical Laboratory
Technology (DMLT) or
Bachelor of Science
(BSc.) Medical
Laboratory Technology
(MLT) or
Master of Science (M.Sc.)
Bio-chemistry or Microbiology qualification from
a recognised university or
institution.
Essential: 1Essential: 2Essential: 4
(c) Support staff
(Laboratory Assistant or
Laboratory Attendant)
Roster of salary of staff,
Periodic health checkups and vaccination of staff
Essential: 1Essential: 1Essential: 2

INSTRUMENTS OR EQUIPMENT OR DRUGS
































































IV






INSTRUMENTS OR EQUIPMENT OR DRUGS






(a) List of minimum medical diagnostics laboratory equipment with quantity






Essential as per scope of services






Essential as per scope of services






Essential as per scope of services






(b) List of minimum medical diagnostics laboratory instruments with quantity






Essential as per scope of services






Essential as per scope of services






Essential as per scope of services






(c) Sterilisation such as hot air oven or autoclave






Essential






Essential






Essential






(d) List of reagents and consumables required






Essential






Essential






Essential






(e) List of Disposables






Essential






Essential






Essential






(f) Policy of annual maintenance contract or comprehensive maintenance contract and records for equipment (Log books)






Desirable






Desirable






Desirable




LEGAL OR STATUTORY REQUIREMENTS





















V






LEGAL OR STATUTORY REQUIREMENTS






Legal or statutory requirements such as under the registration provisions of Biomedical Waste Management Rules, 2016 with State or Union territories’ Pollution Control Board with registration number and date of expiry, site, space, location and environmental requirements to be as per local bye- laws













Essential






Essential






Essential





RECORD MAINTANENCE AND REPORTING

















































VI








RECORD MAINTANENCE AND REPORTING






(a) Reports of all patients date wise and specialty wise for example: Histopathology, Cytology, Haematology and Laboratory Medicine.






Essential (Clinical Establishment to maintain information and statistics provided)






Essential (Clinical Establishment to maintain information and statistics provided)






Essential (Clinical Establishment to maintain information and statistics provided)






(b) Medico legal records, if applicable (as per relevant law)






Essential






Essential






Essential






(c) Record keeping of technicians working in laboratory indicating their details of qualification training and others






Essential






Essential






Essential






(d) A vailability of reference library including books or periodicals or e-journals or Compact Disc (CD)s






Desirable






Desirable






Desirable










(e) Duration of preservation of record (as applicable from time to time)












Essential












Essential












Essential










STANDARDS ON BASIC PROCESSES


































































VII






STANDARDS ON BASIC PROCESSES






(a) Infection Control practices - as per Bio Medical Waste Management Rules, 2016






Essential






Essential


Essential




(b) Safety considerations- use of disposable needles etc






Essential






Essential






Essential






(c) Patient Information and Education






Essential






Essential






Essential






(d) Process of calibration of equipment and reagents






Essential






Essential






Essential






(e) Booklet of Standard operating procedures of all procedures available






Essential






Essential






Essential






(f) Grievance registration and disposal mechanism






Essential






Essential






Essential






(g) Quality Control in the form of external quality assurance scheme or inter-laboratory comparison, as the case may be






Desirable






Desirable






Desirable






(h) Policy of proficiency testing of tests performed.






Desirable






Desirable



Corrigendum: The article initially misinterpreted the gazette notification on the Human requirements. The article has since been corrected to include the correct interpretation. Medical Dialogues team apologises for the inconvenience. 

Meghna A Singhania
Meghna A Singhania

Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She is a member of the Association of Healthcare Journalists. She can be contacted at meghna@medicaldialogues.in. Contact no. 011-43720751

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