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[ 2016 () - – V G a a a () - a a a () : (4) & P a a a (.) / Pd Pd & a a a () > & P a a a () { V - a : \ V X () - & - [. . . 28013/40/2017-] , ( :::: 23 , 2012 ! .. 387() , , -II, 3, (i) # $ H
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th May, 2018
G.S.R. 468(E).—Whereas the draft of certain rules to amend the Clinical Establishments (Central Government)
Rules, 2012 was published, as required under section 52 of the Clinical Establishments (Registration and Regulation)
Act, 2010 (23 of 2010), in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide notification of the
Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, number
G.S.R. 441(E), dated the 5 th
May, 2017 inviting objections and suggestions from all persons likely to be affected thereby;
And whereas objections and suggestions received from the public have been duly considered by the Central
Government;
Now, therefore, in exercise of the powers conferred by section 52 of the said Act, the Central Government
hereby makes the following rules further to amend the Clinical Establishments (Central Government) Rules, 2012,
namely:—
RULES
1. (1) These rules may be called the Clinical Establishments (Central Government) Amendment Rules, 2018.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Clinical Establishments (Central Government) Rules, 2012, (hereinafter referred to as the said rules),
in rule 2, after clause (b), the following clause shall be inserted, namely.—
‘(bb) “Schedule” means the Schedule appended to these rules’.
3. In the said rules, after rule 8, the following rule shall be inserted, namely:—
“8A. Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) — Every
clinical establishment relating to diagnosis or treatment of diseases, where pathological, bacteriological,
¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 9
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.”
4. In the said rules, after rule 9, the following Schedule shall be inserted, namely:-
SCHEDULE
(1) (2) (3) (4) (5)
I Scope of Services These tests (as
mentioned below) can be
performed in basic
tests also.
availability of equipment
availability of equipment
Aspiration
Cytology(FNAC),
for infection, urine
routine examination and
10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
assays need to be
confirmed from the next
in-charge with
qualification and
registration number
displayed separately
(a) Safety hazard and
Biomedical Waste
Desirable Desirable Essential
3. Space requirement
(a) Registration and
waiting room, public
utilities, safe drinking
Desirable Essential Essential
¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 11
water etc.
(e) Reporting and billing
(h) Preservation of the
(j) Temperature control
for specialized equipment
done
done
done
patients for sample
(n) Frozen Section
services
III HUMAN RESOURCE
12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
essential. of the subjects above.
Desirable:
speciality is done, it is
desirable that specialist of
on full time or part time or
outsourced basis.
other speciality is done,
it is desirable that
specialist of that subject
outsourced basis.
composite laboratory.
person possessing
(c) Support staff
(Laboratory Assistant or
Periodic health check-
Essential: 1 Essential: 1 Essential: 2
¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 13
staff
(a) List of minimum
services
services
services
services
Essential Essential Essential
consumables required
(f) Policy of annual
Legal or statutory
requirements such as
registration under the
provisions of Biomedical
Union territories’
space, location and
local bye- laws
Essential Essential Essential
(a) Reports of all
patients date wise and
14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(e) Duration of
(a) Infection Control
[ F. No. Z. 28013/40/2017-MS]
SUDHIR KUMAR, Jt. Secy.
Note: The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (i) vide
notification number G.S.R. 387(E), dated the 23rd May, 2012.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.9
2018-05-23T15:16:01+0530
ALOK KUMAR