2964 GI/2017 (1)
REGD. NO. D. L.-33004/99
EXTRAORDINARY
II— — (i)
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
349]
No. 349] NEW DELHI, FRIDAY, MAY 5, 2017/VAISAKHA 15, 1939
सवास यर रि वा लयाण मतरालय
(सवास यर रि वा लयाण मभवगा
अभिसचना
नईदिली, 5तई,2017
सा.ला.भन. 441(अ .—निाभनलसथारन (लनदरीयस ला भनयत,2012लार सशोिनल न ल भलएलभिरय
भनयतो ला भनमनभलभति ार, भिनदह लनदरीय स ला ला निाभनल सथारन ( भिसरील ण मर भवभनयतन अभिभनयत,
2010 (2010ला23 लीिा ा52दवा ाितिली ईशभियोलायो ल िहए,निाभनलसथारनो ल भलए ारीय
रि षिसर ातशशल नलरशचाि,बनानलासिावह,उनसगीवयभियोलीिानला ीलभलए,भिनलउससगाभवि
होनलीसगावनाह,लाभशिदलयािािाहर इसलदवा ायहसचनािीिािीहदलउकिारभनयतोर उसिा ीत
स, भिसलोइनार भनयतोवालगा ि ल ािररलीभियािनिालोउरलबिल ािीिािीह,रिालीस दिनली
अवभिलीसताभिर याउसलरशचाि,भवचा दलयािाए ा।
ऐसआकषरर सझाव,यदिलोईहो,अव सभचव(भचदलतसासवा ,सवास यर रि वा लयाण मतरालय,गा ि
स ला ,लत ास.508,डीवव ,भनताशण मगवन,नईदिली-110011लोगििासलिहया[email protected]
र तलदलएिासलिह।
ऐसआकषरोर सझावोर ,िोऊर भवभनरिशटअवभिलगीि दलसीवयभिसािहो,लनदरीयस ला दवा ा
भवचा दलयािाए ा।
ारभनयत
1.(1 इनभनयतोलासभकषिनातनिाभनलसथारन(लनदरीयस ला सशोिनभनयत,2017ह।
(2 य ािररतउनलअभितलाशनलीिा ीतलोवतिहो ।
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2.निाभनलसथारन(लनदरीयस ला भनयतल,2012(भिसइसतइसलरशचािउकिभनयतलहा याह भनयत2त,तड
(त लरशचािभनमनभलभतितडअनदि:सथाभरिदलयािाए ा,अथाशि.-
‘(तत “अनसची”सइनभनयतोससलगनअनसचीअभगिह।’
3.उकिभनयतोत,भनयत8लरशचािभनमनभलभतिभनयतअनदि:सथाभरिदलएिाए ,अथाशि:-
‘‘8ल.भनिानया ो ोलउरचा लभलएनदयनिततानल.—भनिानया ो ोलउरचा ससबभिितयलनिाभनल
सथारन, िहा यो शाला या अनदय भचदलतसीय उरसल ली सहायिा स भवलभि भवजञान, िीवाण म भवजञान, आनवभशली,
भवदल ण म भवजञान, ासायभनल, िभवल अनदवषण म या अनदय निाभनल या िाच-रडिाल सबिी सवाए ाय: ली िािी ह, व
अनसचीतयथाभवभनरिशटसभविा र सवा लनदयनिततानलोलाअनरालनल ।’’
4.उकिभनयतोत,भनयत9लरशचािभनमनभलभतिअनसचीअनदि:सथाभरिलीिाए ी,अथाशि:-
‘‘अनसची
करतस. यो शालालाला बभनयािीभवभवि तधयतयो शाला उनदनियो शाला
I रि गाषा यो शालाए िो 30
नतनो ला ससल ण म
ल िीह
यो शालाए िो 30 स
100 नतनो ला
ससल ण मल िीह
यो शालाएिो100सअभिल
नतनोलाससल ण मल िीह
II सवा लाभवसिा यर ीकषण मलायशकषरलनदरो
र चलिी-दि िी
यो शाला त गी दलए
िासलिह
इन र ीकषण मो ल अलावा
बभनयािी भवभवि
यो शाला त नीच
उभलभतिर ीकषण म दलए
िासलिह
तधयत यो शाला त दलए
िा ह र ीकषण मो ल अभिि कि,
नीच उभलभति अभिि कि
र ीकषण मदलएिासलिह
(ल िीव सायन नतीिीव सायन
र ीकषण मिसबलडश ,
ि नलिकशनर ीकषण म,
भलव िकशनटसट,
अतीलस,भलरासभलभरड
ोिाइल,स ीबरो
सराइनलफलड
(सीएसएि र अनदय
िभवलफलडस,(गललोस
र ोटीन,ओ ल
गललोसटाल सटसट,
इलकरोलाइटस,
लभशयतयािासिट,
एचबीए1सीर लोई
शल ासायनआिाि ि
भरडटसट
(ल नतीिीव- सायन,
(त हा तोनबायोएसस,
टयत तालशसश,लािता
ोटीनइलरोिी भसस
(ल नतीिीव- सायन,
(त हा तोनबायोएसस,टयत
तालशसश, लािता ोटीन
इलरोिो भसस, लोया लशन
ोिाइल, डर तानीटर र
भवषभवजञानएसस
( अण मआनवभशली सदकरया
लीनसर शलरिट
(त भि भवजञान हतोगरात,बलीवड टाइत,
कलोरट टाइत,
ोथरोतभबनटाइत,
एलटीबटडरा भसयल
हतोगरात,बलीवड
टाइत,कलोरट टाइत,
ोथरोतभबनटाइत,
एलटीबटडरा भसयल
सगीअनदयभि भवजञानसबिी
र ीकषण मगी
II (i) 3
थरोबोलाभसटनटाइत,
बलडगरवर
थरोबोलाभसटनटाइत,
बलडगरवर ,लो लशन
एसस
( ऊिलभवलभि
भवजञान
ला नहीहोिा होसलिाहयानहील
सलिह(वलभरल
ऊिल-भवलभिभवजञानर ीकषण म
(घ अण मआनवभशली ला नहीहोिा होसलिाहयानहील
(वलभरल
अण मआनवभशली
(ङ लोभशलाभवलभि
भवजञान
ला नहीहोिा रीएरीसतीअ ,िाइन
नीडलएसभर शन
बल त(एिएनएसी
र सीएसएिलोभशला
भवजञान
रीएरीसतीअ ,एिएनएसी
र बल त(साईटोलोिी
लोभशलाभवलभिभवजञानर
अनदय
वाछनीय:
अरासाउडर सीटी
ता शिरशशिएिएनएसी
(च भि कषाऊिल
भवलभिभवजञान
ला नहीहोिा ला नहीहोिा भि कषाऊिलभवलभिभवजञान
यो शालालभवसिा ल
अनसा
(छ भचदलतसा
सकषतिीवभवजञानर
भि कषाभवजञान
बभनयािीर ीकषण मिस
भरडटसट(वाइटआि
लय सकरतण मलभलए
र ीकषण म,तरटीन
र ीकषण मताइकरोसलोरी,
हव डरारिा भववि यो
लोल ,सटलिा ओवा,
सौली।सगीएचआईवी
रॉभििटव भरडएसस
भिसलीरभिअ लसि
लीनिाभनलयो शाला
सलीिाए ी
(ल बभनयािीभवभवि
यो शालातल
बभनयािीर ीकषण म
(त भवषाण म,िीवाण म,
ििि,र िीवीसबिी
सी तभवजञानर ीकषण म
( लषशण मसविनशीलिा
र ीकषण म,िीवाण मया
ििि
(घ गरातसलअलावा
अनदयभवशषिबब
(ल बभनयािीभवभवि
यो शालातलबभनयािी
र ीकषण म
(त भवषाण म,िीवाण म,ििि,
र िीवीसबिीसी तभवजञान
र ीकषण म
( लषशण मसविनशीलिा
र ीकषण म,िीवाण मिििया
भवषाण म।
(घ िीनआिाि िर ीकषण म
(नदयदलभललएभसडर ीकषण म
सकरतण मिसि यलटाइत
रॉलीत सचनि एकशन
(रीसीआ र ीकषण मलभलए,
सकरभति ो ोलभलएऊिल
भवलभिभवजञानर ीकषण म।
वाछनीय:
इमयनोसाइटोचभतसरी
III अवस चना
बभनयािीभवभवि तधयत उनदनि
1.सालभिलभचहन
बभनयािीसाइनि-
सभविालगीि या
बाह एलसाइनि
उरलबिहो ाभिसत
भनमनभलभतििानला ी
हो ी
आवशयल आवशयल आवशयल
4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(ल अहशिार
भिसरील ण मसायाल
लसाथगा सािल
वयभिलानात
आवशयल आवशयल आवशयल
(त िीिानवाली
वयारलसवाएअथाशि
भि भवजञान,िव
सायन,निाभनल
भवलभिभवजञान,ऊिल
भवजञान,अण म
आनवभशलीिोलोई
गीला हो
आवशयल आवशयल आवशयल
( भवभगनदन
र ातशशिािा ली
सतयसा ण मी
आवशयल आवशयल आवशयल
(घ भतलनलासतय
भनयिल नलभलए
इनदट नटसभविाया
टलीिोनर तोबाइल
न.
वाछनीय वाछनीय वाछनीय
(ङ िीसस चना:
अल सिरशशिली
िाए ीर इसल
अनदि शिअनदवषण मर
गा गीहअथाशि
भवशषयानतीर ीकषण म
आवशयल आवशयल आवशयल
2.सालभिलभचहन(िहालहीला हो
(ल स कषाति ार
चिावनीभचहन-
िवभचदलतसाअरभशट
बिनभनयत,2016
लअनसा
िवभचदलतसाअरभशट
लो ीनभडबबोत
अल -अल ल ना,
भिसलअनदि शि
भवदल ण मसातगरी,
भवषल सायन,
ताइकरोबाइलएिनदटस,
सकरभतििभवलीय
सातगरीगीह।
आवशयल आवशयल आवशयल
(त सतभचिअभि
भनलाससालभिल
भचहन-नदयनितएल
अभिशातल
वाछनीय वाछनीय आवशयल
II (i) 5
3.सथानअरकषा
(ल भिसरील ण मर
िीकषालकष,
िनउरयो ीसभविाए,
स भकषिरीनलारानी
आदि
वाछनीय आवशयल आवशयल
(त नतनासगरहण मकषर आवशयल आवशयल आवशयल
( रयाशिभडफयस
र सराटलाइरट ल
साथयो शाला
आवशयल आवशयल आवशयल
(घ शौचालय आवशयल आवशयल आवशयल
(ङ ि रोटशिनर
भबवल कषर
आवशयल आवशयल आवशयल
(च सटाितर
डाकट लाटीत-
िहा24घटलीसवाए
उरलबिहवहारष
र तभहला ललकष
अल -अल हो
वाछनीय वाछनीय आवशयल
(छ वावश त आवशयल आवशयल आवशयल
(ि नतनोर
सलाइडोलारि कषण म
आवशयल आवशयल आवशयल
(झ भवदयिसभविाए आवशयल आवशयल आवशयल
(ञ भवशषउरसल
िसफलोसाइटोतीट ी
र चतइयभतनीसनदस
उरसल ,एिाइत-
वलकडइतयनसो बट
एसस(ईएलआईएसए
र ीकषण मउरसल आदि
लभलएिारतान
भनयरल
आवशयल आवशयल आवशयल
(ट एचआईवीलभलए
र ातशशलकष
आवशयलयदिएचआईवी
र ीकषण मदलया याह
आवशयलयदि
एचआईवीर ीकषण म
दलया याह
आवशयलयदिएचआईवी
र ीकषण मदलया याह
(ठ सगी ोभ योल
नतनोलसगरहण मल
भलएएिएनएसीलकष
वाछनीय वाछनीय वाछनीय
(ड इतनोफलो ससल
भलएडालश त
ला नहीहोिा ला नहीहोिा आवशयल
(ढ फरोिनसकशन
सभविाए
ला नहीहोिा सवा लभवसिा ल
अनसा आवशयल
सवा लभवसिा लअनसा
आवशयल
4.िनीच र
दिकसच
आवशयल आवशयल आवशयल
6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
5.ससचनािर-सतय
भनयिल नलभलए
टलीिोनर तोबाइल
न.
वाछनीय वाछनीय वाछनीय
6.वाशबभसन आवशयल आवशयल आवशयल
IV तानवससािन
रिनात,यो शालाल
िलनीलीगा सािल
याभवशषजञया
हसिाकष लिाशली
नदयनितअहशिा
आवशयल:दलसी
तानदयिाािससथास
बचल आितभडभसन
एडबचल आिसिश ी
(एतबीबीएस
(यो शालालायशतलत
सलतएलवषशला
अनगव-वाछनीय
आवशयल:गा सािल
भवलभिभवजञानया
िव सायनया
भचदलतसीयसकषतिभवली
यायो शालाओषभि
तडाकट आितभडभसन
(एतडी याभडलोतट
आिनशनलबोडश
(डीएनबी यानिाभनल
भवलभिभवजञानत
भडलोता(डीसीरी
र भडलोतालरशचाि
एलवषशलाअनगवया
बचल आितभडभसन
एडबचल आिसिश ी
(एतबीबीएस लसाथ
िीनभवषयोतसएल
भवषयतडाकट आि
िलॉसिी(रीएचडी ,
गा सािलहोसलिाह
याइसलअभिि कि
यदिअनदयभवशषजञिाला
लोईअनदयभवशष
र ीकषण मदलयािािाह
िबयहवाछनीयहदल
उसभवषयलभवशषजञ
लोरण मशलाभललया
अशलाभललरसवहा
हनलीआवशयलिाह
या(भवशषर ीकषण मस
अभगिहनती
बभनयािीिव सायन,
भि भवजञानया
भचदलतसासकषतिभवली
लअभिि किलोईऐसा
र ीकषण मभिसबभनयािी
भवभवियो शालात
सचीबदधदलया याह
आवशयल:गा सािलभवलभि
भवजञानयायो शालाओषभि
िव सायनतडाकट आि
तभडभसन(एतडी याभडलोतट
आिनशनलबोडश(डीएनबी या
निाभनलभवलभिभवजञानत
भडलोता(डीसीरी र
भडलोतालरशचािएलवषशला
अनगवयाबचल आि
तभडभसनएडबचल आि
सिश ी(एतबीबीएस लसाथ
िीनभवषयोतसएलभवषयत
डाकट आििलॉसिी
(रीएचडी ,गा सािलहो
सलिाहयाइसलअभिि कि
यदिअनदयभवशषजञिालालोई
अनदयभवशषर ीकषण मदलया
िािाहिबयहवाछनीयहदल
उसभवषयलभवशषजञलो
रण मशलाभललयाअशलाभललर
सवहा हनलीआवशयलिाह
या(भवशषर ीकषण मसअभगि
हनतीबभनयािीिव सायन,
भि भवजञानयाभचदलतसा
सकषतिभवलीलअभिि किलोई
ऐसार ीकषण मभिसऊर
सचीबदधदलया याह
II (i) 7
भवशवभवदयालयया
तानदयिाािससथास
यो शालाभवजञानत
भडलोताइनतभडलल
लबोर ीटकनोलािी
(डीएतएलटी या
तभडलललबोर ी
टलनोलाि(एतएलटी
याबचल आिसाइस
(बीएससी या
यो शालाभवजञानत
तासट आिसाइस
(एतएससी या
यो शालाभवजञानत
डाकट आििलॉसिी
(रीएचडी अहशिाल
साथयो शाला
िलनीदलयोलीसाया
आवशयल:1 आवशयल:2 आवशयल:4
सहायललतशचा ीवनदि
(यो शालासहायल
यायो शाला,
रि च लतशचाि योल
विनला ोसट ,र
सतयसतयर उनला
सवास यिाचर
टीलाल ण मदलया
िाए ा
आवशयल:1 आवशयल:1 आवशयल:2
V उरसल याउरल ण मयारषभिया
(ल भचदलतसीय
निाभनलयो शालाल
उरसल ोलीनदयनित
तारालीसची
सवा लभवसिा ल
अनसा आवशयल
सवा लभवसिा ल
अनसा आवशयल
सवा लभवसिा लअनसा
आवशयल
(त भचदलतसीय
निाभनलयो शालाल
उरसल ोलीनदयनित
तारालीसची
सवा लभवसिा ल
अनसा आवशयल
सवा लभवसिा ल
अनसा आवशयल
सवा लभवसिा लअनसा
आवशयल
( भवसकरतण मलभलए
िसदलहाटएय
ऑवनर आटोललव
आवशयल आवशयल आवशयल
(घ अरभकषि
अभगलतशलर तरन
वालीवसि लीसची
आवशयल आवशयल आवशयल
(ङ तयाजयोलीसची आवशयल आवशयल आवशयल
(च वारषशलअन कषण म
सभविायावयारल
अन कषण मसभविार
वाछनीय वाछनीय वाछनीय
8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
उरसल लभलए
अभगलत(लॉ
रभसिला लीरॉभलसी
VI भवभिलर लाननीअरकषाए
भवभिलर लाननी
अरकषाएिसदल ाजय
यासघ ाजयकषरोला
िवभचदलतसाअरभशट
बिनअभिभनयतल
उरबिोलअिीन
भिसरील ण म,िषण म
भनयरण मबोडशर
सथानीयउरभवभियोल
अनसा रयाशव ण मीय
अरकषा लसाथ
भिसरील ण मस.र
उसलअवसानली
िा ीत,सथल,ि ह,
अवसथान।
आवशयल आवशयल आवशयल
VII अभगलतबनाए तनार ि रोटशिना
(ल िा ीतवा र
भवशषजञिालअनसा
उिाह ण माथशऊिल
भवलभिभवजञान
लोभशलाभवजञान,
भि भवजञानर
यो शालाओषभिल
अनसा सगी ोभ यो
लीि रोट
आवशयल(निाभनल
सथारनिी ईिानला ी
र उरलबिआलडोलो
बनाए त ा
आवशयल(निाभनल
सथारनिी ईिानला ी
र उरलबिआलडोलो
बनाए त ा
आवशयल(निाभनलसथारनिी
ईिानला ीर उरलबि
आलडोलोबनाए त ा
(त भचदलतसाभवभिल
अभगलत(भवभिल
अनसा यदिला हो
आवशयल आवशयल आवशयल
( यो शालात
लायश ििलनीदलयोल
अभगलतलोबनाए
तनाभिसतउनली
अहशिा,भशकषण मर
अनदयबयौ हो
आवशयल आवशयल आवशयल
(घ भनिशरसिलालय
भिसलअनदि शिरसिल ,
भनयिलाभललरभरलाए
याई-िनशलयालमरलट
भडसल(सीडी उरलबि
ल ाईिाए ी
वाछनीय वाछनीय वाछनीय
II (i) 9
(ङ अभगलतोलो
बनाए तनलीअवभि
(िोसतयसतयर
ला हो
आवशयल आवशयल आवशयल
VIII बभनयािीदकरया लतानल
(ल सकरतण मभनयरण म
लाअनस ण मल ना-
िवभचदलतसाअरभशट
भनयत,2016ल
अनसा
आवशयल आवशयल आवशयल
(त स कषासबिी
बाि-तयाजयसइ ला
यो आदि
आवशयल आवशयल आवशयल
( ो ीलोसचना
र िा ल(भशभकषि
ल ना
आवशयल आवशयल आवशयल
(घ उरसल ोर
अभगलतशलोला
अशालन
आवशयल आवशयल आवशयल
(ङ उरलबिसगी
दकरया लीतानल
सचालनदकरया
रभसिला
आवशयल आवशयल आवशयल
(च भशलायिििश
ल नार उनलो
भनरटानलीदकरयाभवभि
आवशयल आवशयल आवशयल
(छ यथाभसथभि,बाह ी
ण मिाआशवासनसलीत
याआि यो शाला
िलनालरत ण मिा
भनयरण म
वाछनीय वाछनीय वाछनीय
(ि दलए एर ीकषण मो
लीिकषिार ीकषण मली
नीभि
वाछनीय वाछनीय वाछनीय
[िा.स.िड.28013/40/2017-एत.एस.]
लनदिललालशताश, सयकिसभचव
िटरण म:तल भनयत गा ि ल ािरर, असािा ण म, गा II, तणड 3, उर-तड (i) त िा ीत 23 तई, 2012 लो
सा.ला.भन.387(अ लदवा ालाभशिदलए एथ।
10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 5th May, 2017
G.S.R. 441(E).—The following draft of certain rules further to amend the Clinical Establishments (Central
Government) Rules, 2012, which the Central Government proposes to make in exercise of the powers conferred by
section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010), after consultation with
the National Council for Clinical Establishments, is hereby published for information of all persons likely to be affected
thereby and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a
period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made
available to the public;
Objections and suggestions, if any, may be addressed to the Under Secretary (Medical Services), Ministry of
Health and Family Welfare, Government of India, Room No. 508, D Wing, Nirman Bhavan, New Delhi – 110011 or sent
on email to [email protected];
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government.
DRAFT RULES
1. (1) These rules may be called the Clinical Establishments (Central Government) Amendment Rules, 2017.
(2) They shall come into force on the date of their final 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 rules shall be inserted, namely:-
“8A. Minimum Standards for diagnosis or treatment of diseases. - 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”.
4. In the said rules, after rule 9, the following Schedule shall be inserted, namely:-
“SCHEDULE
Sl. No. Type of laboratory Basic Composite Medium Advanced
I Definition Laboratories processing
upto 30 samples.
Laboratories processing
between 30 and 100
samples
Laboratories processing more
than 100 samples
II Scope of services These tests can be
performed in mobile
laboratory at field centres
also.
Apart from the tests
performed in basic
composite laboratory,
additional tests
mentioned as under.
Apart from the 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
dry chemistry based rapid
test.
(a) Routine Bio-
chemistry,
(b) Hormone Bioassay,
Tumor markers,
plasma protein
electrophoresis
(a) Routine Biochemistry,
(b) Hormone Bioassay, Tumor
markers, plasma protein
electrophoresis, coagulation
profile, Drug monitoring and
toxicology assay,
(c) Molecular genetics,
Inborn errors of metabolism
II (i) 11
(b) Haematology Haemogram, Bleeding
Time, Clotting Time,
Prothrombin Time,
Activated Partial
Thromboplastin
Time, Blood grouping
Haemogram, Bleeding
Time, Clotting Time,
Prothrombin Time,
Activated Partial
Thromboplastin Time,
Blood grouping,
Coagulation Assay
All other Haematology tests
also.
(c) Histopathology Not applicable May or may not do
(optional)
Histopathology Examination
(d) Molecular
Genetics
Not applicable May or may not do
(optional)
Molecular genetics
(e) Cytopathology Not applicable PAP smear, Fine
Needle Aspiration
Cytology(FNAC),
sputum and CSF
cytology
PAP smear, FNAC, sputum
cytology and other biological
fluid cytology;
Desirable: Ultrasound and CT
guided FNAC.
(f) Immuno-
histopathology
Not applicable Not applicable Immuno histopathology: As
per scope of laboratory
(g) Medical
Microbiology and
Immunology
Basic tests like Rapid Test
(Point of Care) 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) Basic tests as in
basic composite
laboratory.
(b) Serological tests for
viruses, bacteria, fungi,
parasites
(c) Culture sensitivity
tests: Bacterial or
fungal
(d) Other special stains
besides Gram's.
(a) Basic test as in composite
laboratory.
(b) Serological tests for viruses,
bacteria, fungi, parasites.
(c) Culture sensitivity tests,
bacterial or fungal or viruses.
(d) Gene based tests (Nucleic
acid tests for infections like
Real time Polymerase Chain
Reaction (PCR) tests).
Histopathology of infectious
diseases.
Desirable:
Immunocytochemistry
III INFRASTRUCTURE
Basic Composite Medium Advanced
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 services
provided, i.e.,
Haematology,
Biochemistry,
Clinical Pathology,
Histology Genetics-
whichever is
applicable
Essential Essential Essential
12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(d) Timings of the
different consultants
Essential 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 Signages (Wherever applicable)
(a) Safety hazard
and caution signs -
Biomedical waste
segregated in
coloured bins and
bags as per
Biomedical waste
Management Rules,
2016 including
radioactive
materials, toxic
chemicals, microbial
agents, infected
biological material.
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
II (i) 13
(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 ,
Enzyme-linked
immune sorbent
assay(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
tests of Immuno-
fluorescence
Not applicable Not applicable Essential
(n) Frozen Section
facilities
Not applicable Essential as per scope of
services
Essential as per scope of
services
4. Furniture and
fixtures
Essential Essential Essential
5. Communication
system - Telephone
and mobile number
for appointment
Desirable Desirable Desirable
6. Wash Basins Essential Essential Essential
IV HUMAN RESOURCE
(a) Designation,
minimum
qualification of
Technical Head of
Laboratory or
Specialist or
Signatories.
Essential: Bachelor of
Medicine and Bachelor of
Surgery (MBBS )from a
recognised institution
(with at least one year
experience in laboratory
work-Desirable)
Essential: In-charge
may be 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) with
one year post diploma
experience or Bachelor
of Medicine and
Bachelor of Surgery (MBBS) with Doctor of
Philosophy (PhD) in
any of the 3 subjects or
apart from incharge, if
Essential: In-charge can be
Doctor of Medicine (MD) or
Diplomate of National Board
(DNB) Pathology or
Laboratory Medicine or
Biochemistry or Medical
Microbiology or Diploma in
Clinical Pathology (DCP)
with one year post diploma
experience or Bachelor of
Medicine and Bachelor of
Surgery (MBBS) with Doctor
of Philosophy (PhD) in any of
the 3 subjects or apart from in-
charge, if any special test of
other speciality is done, it is
desirable that specialist of that
subject need be there on full
time or part time or outsourced
14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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
(Special tests means any
other apart from routine
basic biochemistry,
haematology, or
medical microbiology
tests as listed in basic
composite laboratory)
(Special tests means any other
apart from routine basic
biochemistry, haematology, or
microbiology tests as listed
above)
(b) Number of
laboratory
technicians with
Diploma in Medical
Laboratory
Technology (DMLT) or Medical
Laboratory
Technology (MLT) or Bachelor of
Science (B.Sc.) in
laboratory sciences
or Master of Science (M.Sc) in laboratory
sciences or Doctor of
Philosophy (Ph.D)
in laboratory
sciences
qualification from
University or
recognized institution.
Essential: 1 Essential: 2 Essential: 4
(c) Support staff
(Laboratory
Assistant or
Laboratory
Attendant) Roster of
salary of staff,
Periodic health
check- ups and vaccination of staff
Essential: 1 Essential: 1 Essential: 2
V 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
II (i) 15
(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
VI LEGAL OR STATUTORY REQUIREMENTS
Legal or statutory
requirements such as
registration under
the provisions of the
Biomedical Waste
Management Act
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
VII RECORD MAINTENANCE 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
Essential Essential Essential
(c) Record keeping
of technicians
working in
laboratory indicating
their details of
qualification training
and others
Essential Essential Essential
(d) Availability of
reference library
including books or
periodicals or
Desirable Desirable Desirable
16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
[F. No. Z. 28013/40/2017-MS]
K. L. SHARMA, Jt. Secy.
Note: The principal rules were published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) vide
G.S.R. No. 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.
e-journals or
Compact
Discs(CDs)
(e) Duration of
preservation of
record (as applicable
from time to time)
Essential Essential Essential
VIII 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 Desirable”.
Top Related