**Executive Summary:**
This notification from the Ministry of Health and Family Welfare publishes draft rules to amend the Clinical Establishments Central Government Rules, 2012, in accordance with Section 52 of the Clinical Establishments Registration and Regulation Act, 2010. It specifies minimum standards for diagnosis and treatment of diseases in clinical establishments, particularly those involving laboratory investigations. The public has 45 days from the date of publication to submit objections or suggestions, which will be considered by the Central Government.
**Key Points / Main Content:**
* **Amendment Title and Effective Date:** These rules are called the Clinical Establishments Central Government Amendment Rules, 2017, and will come into force upon final publication in the Official Gazette.
* **Insertion of Schedule:** A schedule defining minimum standards for diagnosis or treatment of diseases is added to the Clinical Establishments Central Government Rules, 2012.
* **Minimum Standards for Diagnosis and Treatment (Rule 8A):** Every clinical establishment that conducts pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with laboratory or medical equipment must comply with the minimum standards of facilities and services as specified in the Schedule.
* **Schedule Contents:** The schedule outlines standards for laboratories based on the type of laboratory (Basic, Composite, Medium, Advanced) covering aspects:
* **Scope of Services:** Details the types of tests each laboratory type can perform (Biochemistry, Haematology, Histopathology, etc.).
* **Infrastructure:** Specifies requirements for signage, safety, space, furniture, communication, and essential facilities (toilets, washing rooms, temperature control, etc.)
* **Human Resources:** Defines required qualifications and numbers of technical staff (doctors, technicians) and support staff.
* **Instruments/Equipment/Drugs:** Mandates lists of required equipment, sterilization facilities, reagents, and consumables, as well as annual maintenance contracts.
* **Legal/Statutory Requirements:** Enforces compliance with legal requirements such as registration under the Biomedical Waste Management Act.
* **Record Maintenance and Reporting:** Specifies requirements for maintaining patient reports, medico-legal records, technician details, and record preservation.
* **Standards on Basic Processes:** Covers infection control practices, safety considerations, patient information, equipment calibration, standard operating procedures, grievance mechanisms, and quality control.
**Impact Analysis:**
* **Clinical Establishments (Laboratories):**
* *Impact:* Must adhere to the new minimum standards for facilities, services, infrastructure, staffing, and processes as detailed in the Schedule.
* *Action Required:* Assess current facilities and practices against the Schedule's requirements, implement necessary changes to comply with the standards, and ensure proper documentation and record-keeping.
* **Central Government (Ministry of Health and Family Welfare):**
* *Impact:* Responsible for reviewing and incorporating feedback on the draft rules before final publication.
* *Action Required:* Review and consider all objections and suggestions received within the specified timeframe, finalize the rules, and publish them in the Official Gazette.
* **Public/Citizens:**
* *Impact:* Indirectly affected through improved standards of diagnosis and treatment in clinical establishments.
* *Action Required:* Review the draft rules and submit any objections or suggestions to the Ministry of Health and Family Welfare within 45 days of the rules being made available to the public.
Key Entities Referenced
Clinical Establishments Central Government Rules, 2012: A set of rules that the notification proposes to amend.
Clinical Establishments Registration and Regulation Act, 2010: The Act that confers powers to the Central Government to make rules regarding clinical establishments.
National Council for Clinical Establishments: An entity consulted by the Central Government regarding amendments to the rules.
Ministry of Health and Family Welfare: The government ministry responsible for the notification and related rules.
New Delhi, Delhi: The location of the Ministry of Health and Family Welfare, where the notification was issued.
Clinical Establishments Central Government Amendment Rules, 2017: The name of the rules that are proposed to be enacted.
Biomedical Waste Management Rules, 2016: Rules pertaining to the management of biomedical waste, which clinical establishments must adhere to.
K. L. Sharma: The Joint Secretary who approved the notification
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
स्व ास््य र रि वा ल्य ाण मतर् ालय
(स्व ास््य र रि वा ल्य ाण मभवगा
अभिसचू ना
नईदि्ली, 5तई,2017
सा.ला.भन. 441(अ .—नैिाभनलस्थ ारन(लेन्दरीयस ला भनयत,2012लार स्शोिनल ने लेभलएलभिरय
भनयतोंलाभनम्न भलभति्ाूर,भिन्दहें लेन्दरीयस ला लानैिाभनलस्थारन( भिस्रील ण मर भवभनयतन अभिभनयत,
2010(2010ला23 लीिा ा52द्वा ा्ित्िली ईशभियोंला्यो ल िे हुए,नैिाभनलस्थारनोंलेभलए ारीय
रि षि् सेर ातशशल नेलेरश्च ाि्,बनानेला्स्िावह,ैउनसगीव्यभियोंलीिानला ीलेभलए,भिनलेउससे्गाभवि
होनेलीस्गावनाहै,्लाभशिदलयािािाहै र इसलेद्वा ायहसूचनािीिािीहै दलउक्ि्ाूरभनयतोंर उसिा ीत
स,े भिसलोइन्ाूरभनयतोंवालेगा िले ािररली्भिया्िनिालोउरलब्िल ािीिािीह,ंरंिालीसदिनली
अवभिलीसताभिर याउसलेरश्चाि,्भवचा दलयािाए ा।
ऐसेआक्षेरर सुझाव,यदिलोईहों,अव सभचव(भचदलत्सासेवा ,स्वास््यर रि वा ल्याण मत्रालय,गा ि
स ला ,लत ास्.508,डीवव् ,भनताशण मगवन,नईदि्ल ी-110011लोगेिेिासलिे हं याsunil.kumar20@gov.in
र तले दलएिासलिेहं।
ऐसेआक्षेरोंर सुझावोंर ,िोऊर भवभनर्िश टअवभिलेगीि दलसीव्यभिसे्ा्िहों,लेन्दरीयस ला द्वा ा
भवचा दलयािाए ा।
्ाूरभनयत
1.(1 इनभनयतोंलास्भक्ष्िनातनैिाभनलस्थारन(लेन्दरीयस ला स्शोिनभनयत,2017है।
(2 ये ािररतेंउनलेअ्भित्लाशनलीिा ीतलो्वृत्िहों े।
2964 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2.नैिाभनलस्थ ारन(लेन्दरीयस ला भनयतले,2012(भिसेइसतेंइसलेरश्चाि्उक्ि भनयतलहा याह ै भनयत2त,ेंत्ड
(त लेरश्चाि् भनम्न भलभतितड् अन्दि:स्थ ाभरिदलयािाए ा,अथाशि.्-
‘(तत “अनुसूची”सेइनभनयतोंसेस्लग्नअनुसूचीअभग्ेिहै ।’
3.उक्ि भनयतोंत,ेंभनयत8लेरश्चाि् भनम्न भलभतिभनयतअन्दि:स्थ ाभरिदलएिाए ् ,े अथाशि्:-
‘‘8ल.भनिानया ो ोंलेउरचा लेभलएन्दय नू िततानल.—भनिानया ो ोंलेउरचा सेस्ब्भिि्त्येलनैिाभनल
स्थारन,िहा््यो शालायाअन्दयभचदलत्सीयउरस्ल लीसहायिासेभवलृभिभवज्ञान,िीवाण मुभवज्ञान,आनुव्भशली,
भवदल ण मभवज्ञान, ासायभनल,िैभवलअन्दवेषण मयाअन्दयनैिाभनलयािा्च-रड़िालस्ब्िीसेवाए् ्ाय:लीिािीह,ैवे
अनुसूचीतेंयथाभवभनर्िश टसुभविां र सेवां लेन्दयूनिततानलोंलाअनुरालनल ें े।’’
4.उक्ि भनयतोंत,ेंभनयत9लेरश्चाि् भनम्न भलभतिअनुसूचीअन्दि:स्थ ाभरिलीिाए ी,अथाशि्:-
‘‘अनसु चू ी
क्रतस.् ्यो शालाला्ला बुभनयािीभवभवि तध्य त्यो शाला उन्दन ि्यो शाला
I रि गाषा ्यो शालाए् िो 30 ्यो शालाए्िो30से ्यो शालाए् िो100से अभिल
नतूनों ला ्स्स्ल ण म 100 नतूनों ला नतूनोंला्स्स्ल ण मल िीहं
ल िीहं ्स्स्ल ण मल िीहं
II सेवां लाभवस्ि ा येर ीक्षण मलायक्षश रे लेन्दरों इनर ीक्षण मोंलेअलावा तध्यत ्यो शालां तें दलए
र चलिी-दि िी बुभनयािी भवभवि िा हें र ीक्षण मोंलेअभिि क्ि ,
्यो शाला तें गी दलए ्यो शाला तें नीचे
नीचे उभ्लभति अभिि क्ि
िासलिेहं उभ्लभतिर ीक्षण मदलए
र ीक्षण मदलएिासलिेहं
िासलिेहं
(ल िीव सायन नेतीिीव सायन (ल नेतीिीव- सायन, (ल नेतीिीव- सायन,
र ीक्षण मिैसेब्ल डश ु ,
(त हा तोनबायोएस्से, (त हा तोनबायोएस्से,ट्यूत
ि नलि्क्श नर ीक्षण म,
ट्यूत तालशसश,्लािता तालशसश, ्लािता ्ोटीन
भलव ि्क्श नटेस्ट, ्ोटीनइ्लरोिी ेभसस इ्लरोिो ेभसस, लोया ुलशे न
अतीलेस,भलरासेभलभरड
्ोिाइल, ड्र तानीटर ् र
्ोिाइल,से ीब्रो भवषभवज्ञानएस्से
स्राइनलफ्लडू ( अण मुआनुव्भशली स्दक्रया
(सीएसएि र अन्दय लीनैसर् शलरुिट
िैभवलफ्लडू स्,(ग्ल ूलोस
र ्ोटीन,ओ ल
ग्लूलोसटाल ेंसटेस्ट,
इलेक्रोलाइटस,
लैभ्शयतयािास्िेट,
एचबीए1सीर लोई
शुल ासायनआिाि ि
ेभरडटेस्ट
(त ूभि भवज्ञान हते ोग्रात,ब्लीवड् टाइत, हते ोग्रात,ब्लीवड् सगीअन्दयूभि भवज्ञानस्ब्िी
र ीक्षण मगी
क्ल ोरट् टाइत, टाइत,क्ल ोरट् टाइत,
्ोथ्रोतभबनटाइत, ्ोथ्रोतभबनटाइत,
एलटीबेटेडरा भसयल एलटीबेटेडरा भसयलII (i) 3
थ्रोबो्लाभस्टनटाइत, थ्रोबो्लाभस्टनटाइत,
ब्लडग्रुवर् ब्लडग्रुवर् ,लो ुलशे न
एस्स े
( ऊिलभवलृभि ला ूनहींहोिा होसलिाहैयानहींल ऊिल-भवलृभिभवज्ञानर ीक्षण म
भवज्ञान सलिेहं(वैलभ्रल
(घ अण मुआनुव्भशली ला ूनहींहोिा होसलिाहैयानहींल अण मुआनुव्भशली
(वैलभ्रल
(ङ लोभशलाभवलृभि ला ूनहींहोिा रीएरीस्तीअ ,िाइन रीएरीस्तीअ ,एिएनएसी
भवज्ञान
नीडलएसभर ेशन र बल त(साईटोलोिी
बल त(एिएनएसी लोभशलाभवलृभिभवज्ञानर
र सीएसएि लोभशला अन्दय
भवज्ञान वाछ् नीय:
अ्रासा्उडर सीटी
ता शिर्शशिएिएनएसी
(च ्भि क्षाऊिल ला ूनहींहोिा ला ूनहींहोिा ्भि क्षाऊिलभवलृभिभवज्ञान
भवलृभिभवज्ञान ्यो शालालेभवस्िा ले
अनुसा
(छ भचदलत्सा बुभनयािीर ीक्षण मिैसे (ल बुभनयािीभवभवि (ल बुभनयािीभवभवि
सूक्ष्त िीवभवज्ञानर ेभरडटेस्ट(्वा्इटआि ्यो शालातेंले ्यो शालातेंलेबुभनयािी
्भि क्षाभवज्ञान लेय स्क्रतण मलेभलए बुभनयािीर ीक्षण म र ीक्षण म
र ीक्षण म,तूरूटीन (त भवषाण म,ुिीवाण मु, (त भवषाण म,ुिीवाण मु,िूिू्ि,
र ीक्षण मताइक्रोस्लोरी, िूिू्ि,र िीवीस्ब्िी र िीवीस्ब्िीसी तभवज्ञान
र ीक्षण म
हवे ् ड्रारिा भववि यों सी तभवज्ञानर ीक्षण म
( लषण मश स्वेिनशीलिा
लोले े,स्टूलिा ओवा, ( लषण मश स्वेिनशीलिा
र ीक्षण म,िीवाण मुिूिू्िया
सौली।सगीएचआईवी र ीक्षण म,िीवाण मुया
भवषाण मु।
रॉभििटव ेभरडएस्से िूिू्ि
भिसलीरुभिअ लेस्ि (घ ग्रातसलेअलावा (घ िीनआिाि िर ीक्षण म
लीनैिाभनल्यो शाला अन्दयभवशेषिब्ब े (न्दयदू लभललएभसडर ीक्षण म
सेलीिाए ी स्क्रतण मिैसेि यलटाइत
रॉलीत ेसचेनि एक्शन
(रीसीआ र ीक्षण मलेभलए,
स्क्रभति ो ोंलेभलएऊिल
भवलृभिभवज्ञानर ीक्षण म।
वाछ् नीय:
इम्यनू ोसाइटोचेभतस्री
III अवस ् चना
बुभनयािीभवभवि तध्यत उन्दनि
1.साल् ेभिलभचह्न
बुभनयािीसाइनेि- आवश्यल आवश्यल आवश्यल
सुभविालेगीि या
बाह एलसाइनेि
उरलब्िहो ाभिसतें
भनम्न भलभतििानला ी
हो ी4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(ल अहिश ार आवश्यल आवश्यल आवश्यल
भिस्रील ण मसां् या्ल
लेसाथगा सािल
व्यभिलानात
(त िीिानेवाली आवश्यल आवश्यल आवश्यल
व्यारलसेवाए्अथाशि्
ूभि भवज्ञान,िैव
सायन,नैिाभनल
भवलृभिभवज्ञान,ऊिल
भवज्ञान,अण मु
आनुव्भशलीिोलोई
गीला ूहो
( भवभगन्दन आवश्यल आवश्यल आवश्यल
र ातशशिािां ली
सतयसा ण मी
(घ भतलनेलासतय वा्छनीय वा्छनीय वा्छनीय
भनयिल नेलेभलए
इन्दट नेटसुभविाया
टेलीिोनर तोबाइल
न्.
(ङ िीसस् चना: आवश्यल आवश्यल आवश्यल
अल से्िर्शशिली
िाए ीर इसले
अन्दि शिअन्दवेषण मर
्गा गीहंअथाशि्
भवशेषयानेतीर ीक्षण म
2.साल् ेभिलभचह्न(िहा्लहींला ूहो
(ल स ु क्षाति ार आवश्यल आवश्यल आवश्यल
चेिावनीभचह्न-
िैवभचदलत्साअरभशट
्ब्िनभनयत,2016
लेअनुसा
िैवभचदलत्साअरभशट
लो ् ीनभडब्बोंतें
अल -अल ल ना,
भिसलेअन्दि शि
भवदल ण मसातग्री,
भवषैले सायन,
ताइक्रोबाइलएिेन्दटस,
स्क्रभतििैभवलीय
सातग्रीगीहं।
(त सतुभचिअभि वा्छनीय वा्छनीय आवश्यल
भनलाससा्लेभिल
भचह्न-न्दयनू ितएल
अभिशातलII (i) 5
3.स्थ ानअरक्षे ा
(ल भिस्रील ण मर वा्छनीय आवश्यल आवश्यल
्िीक्षालक्ष,
िनउरयो ीसुभविाए्,
सु भक्षिरीने लारानी
आदि
(त नतूनासग्र् हण मक्षेर आवश्यल आवश्यल आवश्यल
( रयाश्िभडफ्यूस आवश्यल आवश्यल आवश्यल
र स्राटलाइरट् ले
साथ्यो शाला
(घ शौचालय आवश्यल आवश्यल आवश्यल
(ङ ि रोटशिेनेर आवश्यल आवश्यल आवश्यल
भबवल् क्षेर
(च स्टािूतर वा्छनीय वा्छनीय आवश्यल
डाक्ट ला्ूटीूत-
िहा्24घ्टेलीसेवाए्
उरलब्िहै वहा्रुूष
र तभहलां लेलक्ष
अल -अल हों े
(छ वावश् ूत आवश्यल आवश्यल आवश्यल
(ि नतूनोंर आवश्यल आवश्यल आवश्यल
स्लाइडोंलारि क्षण म
(झ भवद्युिसुभविाए् आवश्यल आवश्यल आवश्यल
(ञ भवशेषउरस्ल आवश्यल आवश्यल आवश्यल
िैसेफ्लोसाइटोतीट ी
र चेतइ्यभू तनीसेन्दस
उरस्ल ,ए्िाइत-
वल्क्ड इतयूनसो बेंट
एस्से (ईएलआईएसए
र ीक्षण मउरस्ल आदि
लेभलएिारतान
भनय्रल
(ट एचआईवीलेभलए आवश्यलयदिएचआईवी आवश्यलयदि आवश्यलयदिएचआईवी
र ातशशलक्ष र ीक्षण मदलया याहै एचआईवीर ीक्षण म र ीक्षण मदलया याह ै
दलया याह ै
(ठ सगी ोभ योंले वा्छनीय वा्छनीय वा्छनीय
नतूनोंलेसग्र् हण मले
भलएएिएनएसीलक्ष
(ड इतनोफ्लो सेंसले ला ूनहींहोिा ला ूनहींहोिा आवश्यल
भलएडालशूत
(ढ फ्रोिनसेक्श न ला ूनहींहोिा सेवां लेभवस्िा ले सेवां लेभवस्िा लेअनुसा
सुभविाए् अनुसा आवश्यल आवश्यल
4.िनीच र आवश्यल आवश्यल आवश्यल
दिक्सच 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
5.सस् चू नािर् -सतय वा्छनीय वा्छनीय वा्छनीय
भनयिल नेलेभलए
टेलीिोनर तोबाइल
न्.
6.वाशबभे सन आवश्यल आवश्यल आवश्यल
IV तानवस्सािन
रिनात,्यो शालाले आवश्यल:दलसी आवश्यल:गा सािल आवश्यल:गा सािलभवलृभि
िलनीलीगा सािल तान्दयिा्ा्िस्स्थासे भवलृभिभवज्ञानया भवज्ञानया्यो शालाओषभि
याभवशेषज्ञया बैचुल आितेभडभसन िैव सायनया िैव सायनतेंडाक्ट आि
हस्ि ाक्ष लिाशली ए्डबैचुल आिसिश ी भचदलत्सीयसूक्ष्तिैभवली तेभडभसन(एतडी याभड्लोतेट
न्दयनू ितअहिश ा (एतबीबीएस या्यो शालाओषभि आिनशे नलबोडश (डीएनबी या
(्यो शालालायशतेंलत तें डाक्ट आितेभडभसन नैिाभनलभवलृभिभवज्ञानतें
सेलतएलवषश ला (एतडी याभड्ल ोतेट भड्लोता(डीसीरी र
अनुगव-वा्छनीय आिनशे नलबोडश भड्लोतालेरश्चाि्एलवषशला
(डीएनबी यानैिाभनल अनुगवयाबैचलु आि
भवलृभिभवज्ञानतें तेभडभसनए्डबैचुल आि
भड्लोता(डीसीरी सिश ी(एतबीबीएस लेसाथ
र भड्लोतालेरश्चाि् िीनभवषयोंतेंसेएलभवषयतें
एलवषशलाअनुगवया डाक्ट आििलॉसिी
बैचलु आितेभडभसन (रीएचडी ,गा सािलहो
ए्डबैचुल आिसिश ी सलिाहैयाइसलेअभिि क्ि
(एतबीबीएस लेसाथ यदिअन्दयभवशेषज्ञिालालोई
िीनभवषयोंतेंसेएल अन्दयभवशेषर ीक्षण मदलया
भवषयतें डाक्ट आि िािाहैिबयहवा्छनीयहैदल
िलॉसिी(रीएचडी , उसभवषयलेभवशेषज्ञलो
गा सािलहोसलिाहै रूण मशलाभललयाअ्शलाभललूर
याइसलेअभिि क्ि सेवहा् हनेलीआवश्यलिाहै
यदिअन्दयभवशेषज्ञिाला या(भवशेषर ीक्षण मसेअभग्ेि
लोईअन्दयभवशेष हैनेतीबुभनयािीिैव सायन,
र ीक्षण मदलयािािाहै ूभि भवज्ञानयाभचदलत्सा
िबयहवा्छनीयहैदल सूक्ष्त िैभवलीलेअभिि क्ि लोई
उसभवषयलेभवशेषज्ञ ऐसार ीक्षण मभिसेऊर
लोरूण मशलाभललया सूचीबद्धदलया याह ै
अ्शलाभललूरसेवहा्
हनेलीआवश्यलिाहै
या(भवशेषर ीक्षण मसे
अभग्ेिहैनेती
बुभनयािीिैव सायन,
ूभि भवज्ञानया
भचदलत्सासूक्ष्त िैभवली
लेअभिि क्ि लोईऐसा
र ीक्षण मभिसेबुभनयािी
भवभवि्यो शालातें
सूचीबद्धदलया याह ै II (i) 7
भवश्वभवद्यालयया आवश्यल:1 आवश्यल:2 आवश्यल:4
तान्दयिा्ा्िस्स्थासे
्यो शालाभवज्ञानतें
भड्लोताइनतभे डलल
लेबोर ीटेक्न ोलािी
(डीएतएलटी या
तेभडलललेबोर ी
टेलनोलाि(एतएलटी
याबैचुल आिसाइ्स
(बीएससी या
्यो शालाभवज्ञानतें
तास्ट आिसाइ्स
(एतएससी या
्यो शालाभवज्ञानतें
डाक्ट आििलॉसिी
(रीएचडी अहिश ाले
साथ्यो शाला
िलनीदलयोंलीस्ांया
सहायललतशचा ीवृन्दि आवश्यल:1 आवश्यल:1 आवश्यल:2
(्यो शालासहायल
या्यो शाला,
रि च लतशचाि योंले
वेिनला ोस्ट ,र
सतयसतयर उनला
स्वास््यिा्चर
टीलाल ण मदलया
िाए ा
V उरस्ल याउरल ण मयारषभिया ्
(ल भचदलत्सीय सेवां लेभवस्िा ले सेवां लेभवस्िा ले सेवां लेभवस्िा लेअनुसा
नैिाभनल्यो शालाले अनुसा आवश्यल अनुसा आवश्यल आवश्यल
उरस्ल ोंलीन्दयनू ित
तारालीसूची
(त भचदलत्सीय सेवां लेभवस्िा ले सेवां लेभवस्िा ले सेवां लेभवस्िा लेअनुसा
नैिाभनल्यो शालाले अनुसा आवश्यल अनुसा आवश्यल आवश्यल
उरस्ल ोंलीन्दयनू ित
तारालीसूची
( भवस्क्रतण मलेभलए आवश्यल आवश्यल आवश्यल
िैसेदलहाटएय
ऑवनर आटोललेव
(घ अरेभक्षि आवश्यल आवश्यल आवश्यल
अभगलतशलर तरने
वालीवस्िुं लीसूची
(ङ त्याज्य ोंलीसूची आवश्यल आवश्यल आवश्यल
(च वार्षशलअन ु क्षण म वा्छनीय वा्छनीय वा्छनीय
स्भविायाव्यारल
अनु क्षण मस्भविार 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
उरस्ल लेभलए
अभगलेत(लॉ
रुभस्िला लीरॉभलसी
VI भवभिलर लाननू ीअरक्षे ाए ्
भवभिलर लाननू ी आवश्यल आवश्यल आवश्यल
अरेक्षाए्िैसेदल ाज्य
यास्घ ाज्य क्षेरोंला
िैवभचदलत्साअरभशट
्ब्िनअभिभनयतले
उरब्िोंलेअिीन
भिस्रील ण म,्िषू ण म
भनय्रण मबोडशर
स्थानीयउरभवभियोंले
अनुसा रयाशव ण मीय
अरेक्षां लेसाथ
भिस्रील ण मस.्र
उसलेअवसानली
िा ीत,स्थल,ि ह,
अवस्थान।
VII अभगलते बनाए तनार ि रोटशिेना
(ल िा ीतवा र आवश्यल(नैिाभनल आवश्यल(नैिाभनल आवश्यल(नैिाभनलस्थारनिी
भवशेषज्ञिालेअनुसा स्थारनिी ईिानला ी स्थारनिी ईिानला ी ईिानला ीर उरलब्ि
उिाह ण माथशऊिल र उरलब्िआ्लड़ोंलो र उरलब्िआ्लड़ोंलो आ्लड़ोंलोबनाए त े ा
भवलृभिभवज्ञान बनाए ते ा बनाए ते ा
लोभशलाभवज्ञान,
ूभि भवज्ञानर
्यो शालाओषभिले
अनुसा सगी ोभ यों
लीि रोटें
(त भचदलत्साभवभिल आवश्यल आवश्यल आवश्यल
अभगलेत(भवभिले
अनुसा यदिला ूहो
( ्यो शालातें आवश्यल आवश्यल आवश्यल
लायश ििलनीदलयोंले
अभगलेतलोबनाए
तनाभिसतेंउनली
अहिश ा,्भशक्षण मर
अन्दयब्यौ ेहों े
(घ भनिेशरुस्ि लालय वा्छनीय वा्छनीय वा्छनीय
भिसलेअन्दि शिरुस्िलें,
भनयिलाभललरभरलाए्
याई-िनशलयालम्रेल्ट
भडस्ल(सीडी उरलब्ि
ल ाईिाए ीII (i) 9
(ङ अभगलेतोंलो आवश्यल आवश्यल आवश्यल
बनाए तने लीअवभि
(िोसतयसतयर
ला ूहो
VIII बुभनयािी्दक्रयां लेतानल
(ल स्क्रतण मभनय्रण म आवश्यल आवश्यल आवश्यल
लाअनुस ण मल ना-
िैवभचदलत्साअरभशट
भनयत,2016ले
अनुसा
(त स ु क्षास्ब्िी आवश्यल आवश्यल आवश्यल
बािें-त्याज्य सुइं ला
्यो आदि
( ो ीलोसूचना आवश्यल आवश्यल आवश्यल
र िा ूल(भशभक्षि
ल ना
(घ उरस्ल ोंर आवश्यल आवश्यल आवश्यल
अभगलतशलोंला
अशा्लन
(ङ उरलब्ि सगी आवश्यल आवश्यल आवश्यल
्दक्रयां लीतानल
स्चालन्दक्रया
रुभस्िला
(च भशलायिििश आवश्यल आवश्यल आवश्यल
ल नार उनलो
भनरटानेलीदक्रयाभवभि
(छ यथाभस्थभि,बाह ी वा्छनीय वा्छनीय वा्छनीय
ुण मिाआश्वासनस्लीत
याआ्ि ्यो शाला
िुलनालेूरतें ण मु िा
भनय्रण म
(ि दलए एर ीक्षण मों वा्छनीय वा्छनीय वा्छनीय
लीिक्षिार ीक्षण मली
नीभि
[िा.स्.िडै .28013/40/2017-एत.एस.]
लुन्दिललालशता,श स्युक्िसभचव
िट्र ण म:तूलभनयतगा िले ािरर,असािा ण म,गा II,तण्ड3,उर-त्ड(i)तेंिा ीत23तई,2012लो
सा.ला.भन.387(अ लेद्वा ा्लाभशिदलए एथे।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 sunil.kumar20@gov.in;
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 Laboratories processing Laboratories processing more
upto 30 samples. between 30 and 100 than 100 samples
samples
II Scope of services These tests can be Apart from the tests Apart from the tests performed
performed in mobile performed in basic in medium laboratory,
laboratory at field centres composite laboratory, additional tests mentioned as
also. additional tests under.
mentioned as under.
(a) Biochemistry Routine Biochemistry tests (a) Routine Bio- (a) Routine Biochemistry,
like Blood Sugar, Renal chemistry, (b) Hormone Bioassay, Tumor
Function Tests, Liver (b) Hormone Bioassay, markers, plasma protein
Function Tests, Amylase, Tumor markers, electrophoresis, coagulation
Lipase, Lipid profile, plasma protein profile, Drug monitoring and
Cerebro Spinal Fluid electrophoresis toxicology assay,
(CSF) and other biological (c) Molecular genetics,
fluids (glucose and Inborn errors of metabolism
protein), Oral Glucose
Tolerance Test,
Electrolytes, Calcium or
Phosphate, HbA1c. Any
dry chemistry based rapid
test.II (i) 11
(b) Haematology Haemogram, Bleeding Haemogram, Bleeding All other Haematology tests
Time, Clotting Time, Time, Clotting Time, also.
Prothrombin Time, Prothrombin Time,
Activated Partial Activated Partial
Thromboplastin Thromboplastin Time,
Time, Blood grouping Blood grouping,
Coagulation Assay
(c) Histopathology Not applicable May or may not do Histopathology Examination
(optional)
(d) Molecular Not applicable May or may not do Molecular genetics
Genetics (optional)
(e) Cytopathology Not applicable PAP smear, Fine PAP smear, FNAC, sputum
Needle Aspiration cytology and other biological
Cytology(FNAC), fluid cytology;
sputum and CSF Desirable: Ultrasound and CT
cytology guided FNAC.
(f) Immuno- Not applicable Not applicable Immuno histopathology: As
histopathology per scope of laboratory
(g) Medical Basic tests like Rapid Test (a) Basic tests as in (a) Basic test as in composite
Microbiology and (Point of Care) for basic composite laboratory.
Immunology infection, urine routine laboratory. ( b ) S e r o l o g i c al tests for viruses,
examination and (b) Serological tests for bacteria, fungi, parasites.
microscopy, Hanging drop viruses, bacteria, fungi, (c) Culture sensitivity tests,
for Vibrio cholerae, Stool parasites bacterial or fungal or viruses.
for ova , cyst. all HIV (c) Culture sensitivity (d) Gene based tests (Nucleic
positive rapid assays need tests: Bacterial or acid tests for infections like
to be confirmed from the fungal Real time Polymerase Chain
next level diagnostic (d) Other special stains Reaction (PCR) tests).
laboratory. besides Gram's. Histopathology of infectious
diseases.
Desirable:
Immunocytochemistry
III INFRASTRUCTURE
Basic Composite Medium Advanced
1. Signage
(a) Basic signage- A Essential Essential Essential
signage within or
outside the facility
should be made
available containing
the following
information.
(b) Name of the Essential Essential Essential
person- in-charge
with qualification
and registration
number
(c) Broad services Essential Essential Essential
provided, i.e.,
Haematology,
Biochemistry,
Clinical Pathology,
Histology Genetics-
whichever is
applicable12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(d) Timings of the Essential Essential Essential
different consultants
(e) Internet facility Desirable Desirable Desirable
or Telephone and
mobile number for
appointment
(f) Fee structure: To Essential Essential Essential
be displayed
separately including
type of investigation
and charges, i.e.,
Special and routine
tests
2. Safety Signages (Wherever applicable)
(a) Safety hazard Essential Essential Essential
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.
(b) Appropriate Fire Desirable Desirable Essential
exit signages -
Minimum one fire
extinguisher
3. Space requirement
(a) Registration and Desirable Essential Essential
waiting room, public
utilities, safe
drinking water etc.
(b) Sample Essential Essential Essential
collection area
(c) Laboratory with Essential Essential Essential
adequate diffuse and
spot lighting
(d) Toilet Essential Essential Essential
(e) Reporting and Essential Essential Essential
billing area
(f) Staff room and Desirable Desirable Essential
doctor's duty room -
Male and female
different where 24
hours services
available
(g)Washing room Essential Essential EssentialII (i) 13
(h) Preservation of Essential Essential Essential
the specimens and
slides
(i) Electrical Essential Essential Essential
facilities
(j) Temperature Essential Essential Essential
control for
specialized
equipment like flow
cytometry and
chemiluminescence
equipment ,
Enzyme-linked
immune sorbent
assay(ELISA) test
equipment etc.
(k) Counselling Essential, if HIV test is Essential, if HIV test is Essential, if HIV test is done
room for HIV done done
(l) FNAC room for Desirable Desirable Desirable
all patients for
sample collection
(m) Dark room for Not applicable Not applicable Essential
tests of Immuno-
fluorescence
(n) Frozen Section Not applicable Essential as per scope of Essential as per scope of
facilities services services
4. Furniture and Essential Essential Essential
fixtures
5. Communication Desirable Desirable Desirable
system - Telephone
and mobile number
for appointment
6. Wash Basins Essential Essential Essential
IV HUMAN RESOURCE
(a) Designation, Essential: Bachelor of Essential: In-charge Essential: In-charge can be
minimum Medicine and Bachelor of may be Doctor of Doctor of Medicine (MD) or
qualification of Surgery (MBBS )from a Medicine (MD) or Diplomate of National Board
Technical Head of recognised institution Diplomate of National (DNB) Pathology or
Laboratory or (with at least one year Board (DNB) in Laboratory Medicine or
Specialist or experience in laboratory Pathology or Biochemistry or Medical
Signatories. work-Desirable) Biochemistry or Microbiology or Diploma in
Medical Microbiology Clinical Pathology (DCP)
or Laboratory Medicine with one year post diploma
or Diploma in Clinical experience or Bachelor of
Pathology (DCP) with Medicine and Bachelor of
one year post diploma Surgery (MBBS) with Doctor
experience or Bachelor of Philosophy (PhD) in any of
of Medicine and the 3 subjects or apart from in-
Bachelor of Surgery charge, if any special test of
(MBBS) with Doctor of other speciality is done, it is
Philosophy (PhD) in desirable that specialist of that
any of the 3 subjects or s u bject need be there on full
apart from incharge, if time or part time or outsourced14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
any special test of other (Special tests means any other
speciality is done, it is apart from routine basic
desirable that specialist biochemistry, haematology, or
of that subject needs be microbiology tests as listed
there on full time or part above)
time or outsourced
(Special tests means any
other apart from routine
basic biochemistry,
haematology, or
medical microbiology
tests as listed in basic
composite laboratory)
(b) Number of Essential: 1 Essential: 2 Essential: 4
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.
(c) Support staff Essential: 1 Essential: 1 Essential: 2
(Laboratory
Assistant or
Laboratory
Attendant) Roster of
salary of staff,
Periodic health
check- ups and
vaccination of staff
V INSTRUMENTS OR EQUIPMENT OR DRUGS
(a) List of minimum Essential as per scope of Essential as per scope Essential as per scope of
medical diagnostics services of services services
laboratory
equipment with
quantity
(b) List of minimum Essential as per scope of Essential as per scope of Essential as per scope of
medical diagnostics services services services
laboratory
instruments with
quantityII (i) 15
(c) Sterilisation such Essential Essential Essential
as hot air oven or
autoclave
(d) List of reagents Essential Essential Essential
and consumables
required
(e) List of Essential Essential Essential
disposables
(f) Policy of annual Desirable Desirable Desirable
maintenance contract
or comprehensive
maintenance contract
and records for
equipment (Log
books)
VI LEGAL OR STATUTORY REQUIREMENTS
Legal or statutory Essential Essential Essential
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
VII RECORD MAINTENANCE AND REPORTING
(a) Reports of all Essential (Clinical Essential (Clinical Essential (Clinical
patients date wise Establishment to maintain Establishment to Establishment to maintain
and specialty wise information and statistics maintain information information and statistics
for example: provided) and statistics provided) provided)
Histopathology,
Cytology,
Haematology and
Laboratory
Medicine.
(b) Medico legal Essential Essential Essential
records, if applicable
(c) Record keeping Essential Essential Essential
of technicians
working in
laboratory indicating
their details of
qualification training
and others
(d) Availability of Desirable Desirable Desirable
reference library
including books or
periodicals or16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
e-journals or
Compact
Discs(CDs)
(e) Duration of Essential Essential Essential
preservation of
record (as applicable
from time to time)
VIII STANDARDS ON BASIC PROCESSES
(a) Infection Control Essential Essential Essential
practices - as per
Bio- Medical Waste
Management Rules ,
2016
(b) Safety Essential Essential Essential
considerations- use
of disposable
needles etc
(c) Patient Essential Essential Essential
Information and
Education
(d) Process of Essential Essential Essential
calibration of
equipment and
reagents
(e) Booklet of Essential Essential Essential
standard operating
procedures of all
procedures available
(f) Grievance Essential Essential Essential
registration and
disposal mechanism
(g) Quality Control Desirable Desirable Desirable
in the form of
external quality
assurance scheme or
inter-laboratory
comparison, as the
case may be
(h) Policy of Desirable Desirable Desirable”.
proficiency testing
of tests performed.
[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.