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


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

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: 1 Essential: 2 Essential: 4
(c) Support staff
(Laboratory Assistant or
Laboratory Attendant)
Roster of salary of staff,
Periodic health checkups and vaccination of staff
Essential: 1 Essential: 1 Essential: 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. 


Source: self
7 comment(s) on Minimum Standard of Medical Diagnostic Laboratories: Union Government notifies Clinical Establishment Rules

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  1. Yes its a absolutely correct decision by govt..

  2. user
    Dr. Mahesh Satwekar May 23, 2019, 2:57 pm

    This is not an ideal step by the decision makers. Only MBBS who learns the basic paraclinical sciences for short term may not be able to justify his/her own work and competency. For every kind of laboratory work a specialised trained professional is required. In fact decision and policy makers are waisting the human resources as these MBBS graduates are more required in clinical or patients services rather than waisting valuable human resources in laboratory work. At first place do we require any MBBS to sign the reports which are generated based on some machines? What about the reports which are generated at bed side as an emergency? Now if in CCU expert wants to know the values of cardiac markers or he will wait for the MBBS to sign that . I think this biased decision and should be thought about it before implementing the same.

  3. user
    Dr Sanjoy k.Ghosh DHMS,DMLT,AMAIIMT Kol.Az May 27, 2019, 1:24 pm

    I do support u 100% .We don\’t have sufficient no.of doctors.We should think that Lab report & Lab diagnosis are not same.Lab report must be signed by the dealing Medical Technologist .Counter signed may by the M.O.( Path.or experienced in the test related sub.) accepted.In my 38 yrs. experience in the Clinical Lab & Blood Bank as a Qualified M.T. I realise that maximum MO don\’t have skilled experience in the field of the Lab.They have highly theoretical knowledge about the subject . Suppose a tech can do easily 100 Bl.Sug within 2 hrs.that much work can\’t be done by the MO.That is why it is not possible for a MO to look after a tech that what is what is done by the tech. Than how is it possible to sign the report.I know maximum MO sign the report on feth.What ever parameters are done or examined by the tech that reports must be signed by the respective MT.In the Clinical Lab there are so many parameters which are not tested or examined by the MT directly like Biopsy,Cell cytology etc .MT has limitation.Many parameters are tested by the MT directly even no MO looks after about test.In case of emergency in every where Clinician needs data to start immediate treatment to save the life of
    patient like ABG,Bl.Sug Blood Group etc.I have experienced that many Doctors depend & believe on the MT on emergency of their relative treatment.Every high official of Medical Education know very well that every hospitas Lab run by the MT at night even on the days when pathologist on leave or on official tour.So Medical I\’m must sign the reports within their capacity of answerable knowledge.

  4. user
    Dr P Sudhendra May 23, 2019, 5:35 pm

    Dr mahesh is right, majority results will be given by respective computer, technical people who are trained are enough to support clinical professional Don\’t waste clinical personnel to be in charge of to sign mere paper when we have shortage of such personnel

  5. the medical profession is passing from a bad phase, because of scholars like you, who don\’t have respect fot their education. How come MBBS is a useless basic degree, what the special you learn in those 3 years which you couldnt learn in 5 & 1/2 years. In our nation graduate is required to become CJI, to become governor of RBI but you specialist think that only MD knows every thing. You people have forgot that MBBS is your licence to practice and MD is skill enhancement, whcich even a MBBS doctor can attain with his experience in field.

  6. Once upon a time MBBS doctor was the one who used to treat all types of diseases. Now after PG courses have become popular, MBBS people are looked down. Even PG Diploma holders are not given their due in recognizing their training and skills and experience. It looks somewhat like a caste system among medical fraternity where PG Diploma holders cannot have much advancement in their career even though they do the same duties of a PG degree holder.

  7. Yes this is a progressive step