The TRIPURA CLINICAL ESTABLISHMENT (REGISTRATION AND REGULATION) ACT, 2018

NNoo.. 11334444 RReeggisistetreerded NNoo.. NN.. EE.. 993300.. TTRRIPIUPRAURA GGAAZEZTETETTE PPuubblilsihsehded bbyy AAuuththoroityrity EEXXTTRAROARODINRADRYINARY IISSSUSEUE AAggaartratlaal,a, TThhuurrssdadya,y, DDeecceemmbebrer 2200,, 22001188 AA.. DD..,, AAggrarahahyaaynaana 2299,, 11994400 SS.. EE.. PPAARRTT—--IIIIII—-- AAcctsts ooff TTrriippuurara LLeeggisislaltautruere GOVERNMENT OF TRIPURA LAW DEPARTMENT SECRETARIAT :AGARTALA Dated, Agartala, the 2200tthh December, 2018. NOTIFICATION The following Act of the Tripura LegislativeAssembly received the assentof theGovernorof Tripuraonthe18thDecember2,018andisherebypublishedfor General information. D.M ,Jamatia L,R. & Secretary, Law Government of Tripura Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. The Tripura Act No.16. THE TRIPI RA CLINICAL ESTABLISHMENT (REGISTRATION AND REGI LATION) ACT, 2018. ACT to provide for the registration and regulation of clinical establishments in the Tripura and for matters connected therewith or incidental thereto, WHEREAS, it is considered expedient to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of theilities and services which may be provided by them, so that mandate of article 47 of the Constitution for improvement in public health may be achieved; BE it enacted by the Tripura Legislative Assembly in the Sixty ninth year of the Republic of India as follows: CHAPTER 1 Preliminary Short title and commencement l. This may be called the 'Tripura Clinical Establishment (Registration and Regulation) 2018'; 2. It shall come into force 011the date of its publication ill the Tripura Gazette. 3. It excludes the facility of Defense Forces, 2 Detinitions In this Act, unless the context otherwise requires:- GI) '(tlinical establishmenl't means- (i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system Df medieme established and administered or maintamed by any person or body of persons, whether incorporated or not, andor (lei) a place established as an independent entity or patt of an establishment referred to in sub-clause O), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or Illaintained by ally person or body of persons, whether inecnorated or not, and shall also include an establishment, established, administered or maintained by- (u) the Government or adepartment of the Government, (b) atrust, whether Pliblie or privalet 22 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. (c) a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government, (d) a local authority; and (e) a praetieing doctor, but does not include the clinical establishments owned, controlled or managed by the Armed Forces. Euvplunution.=For the purpose of this clause "Armed ForceS" means the forces constituted under the Army Act, 1950 (46 of 1950) ,the Air Force Act, 1950 (45 of 1950) and the Navy Aet, 1957 (62 of 1957) or any other law for the time being in force; (b) "Clinical laboratory" means an establishment where — i. Biological, pathological, bacteriological, radiological, virological- chemical or other tests, examinations or analysis. or ii. The preparation of cultures, vaccines serums or other biological or bacteriological products, In connection with the diagnosis or treatment of diseases, are of is usually carried on; (c) "Maternity home" means an establishment where women are usually received or accommodated or boih for the purpose of confinement and antenatal and posi-natål care in connections with child —birth (d) "Nursing home" means an establishment where persons suffering from illness injury or infirmity whether of body or mind are usually received or accommodated or both for the purpose of nursing and treatment and includes it maternity home ; (e) "Collection centre" means an establishment where biological samples are usually collected or stored for analysis from other laboratory or its own laboratory in another area. (0 'tPhysiea1 therapy establishment" means an eståblishment where persons are usually treated by physical means such as message, electrotherapy; hydrotherapy; remedial gymnastics or the like ; (g) "Prescribed" means prescribed by rules made under this Aet ; (h) "Qualified medical praetitioner" rneans a medical praetitioner registered in Tripura Medical Council or MCI under a law for the registration of medical practitioner (i) "Qualitied midwife" means a midwife registered in an state in India under a law for the registration of midwives; Qi) "Qualified nurse" means a nurse registered in a state in India under a law for the registration ofnurse. (k) eQualified pathologist" means a medical practitioner with required q»alification in pathology registered in any state in India under a law for the registration of medical praetitioner. (l) "Qualified radiologist" means a medical practitioner with required qualification in Radiologist register in a State in India under a law for the registration of medical practitioner. (my Qualified Microbiologistl' means a medical practitioner with required qualification in Microbiology register in a State in India under a law for the registration of medical practitioner. (n) "Qualified Biochemist" means a medical practitioner with required qualification in Biochemistry register in a Stale in India under a law for the registration of medical practitioner. 33 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. (o) "Register" means to register under section 8 of this Act and the expression '*registered and"registration" construed accordingly, (p} "Rules" rulesmade underthis Act ; (q} "Siq•ervising authority-v rneansthe personof authorny appointed bythe state Government by nolifieation in the Official Gazette, to all or or the functions of supervising authority this Act, (r) "Practicing Doctor" inany system ofMedicine, The State Council for Establishment Establishment of State Council Siaie Government shall by notification constitute aSlateCouncil rorthe purposes of this Act. Willi effect from such as may be appointed by the State sueh ion; State Council, Quill consist ofthe followiil menihers, namel Secretary. Health Ev c"fjcjo, shall be the Chairman; [Hector of Family Welfare & Ex Member. Preventive Medicine Secretary; An officer, not below the Ex & rank of a hint Director Slate Nk3dxl Family Welfare Preventive Medicine d istrur-cum,Secret State Medical Council of Tri Lira isirar Slate Nursin Council Of Tr• uru Member isir:ur State Council ofTTi Branch Officer front Hcilijeopatliic and of the Directorate Of each District Secretary Indian Medical Association, T State Branch Duration or Sate Council {i) The Cluration of the State cooncil •.011be for a tetjii Of three (jj) If any vacancy arises dueto expiry or absence member, then Fimjly & preventive with prior approval of Governmem nentinate unyother of the Directorate to Ell the vacancy. S. Function or State Council 'Jhe Statecouncil shall pecfocm functions. namely — (o) compiling StateRegistersofclinieal establishment. (h) sending monthly relunusfor updating the Nåtional Register, (c} representing the Statein theNuiional Council, hearing Ofappeals against the Oj•dejsOfthe authority. and 44 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. (e) publication on annual basis areport on the state of implementation of standards within their respective States. CIMPTER 111 The District Council for Clinical Establishment. 6. District Council for Clinical Establishment The State Government Shall, by notification, set-up an authority to be called the district registering authority for each district for registration and supervising of clinical establishments, with the f0110wing members, namely: (0) District Magistrate & Collector ofthe District or any other officer, nominated by him, not below the rank of Addl. DM Chairperson; (b) Chief Medical Officer Co-ChaWperson; (c) District Health Officer District Nodal Officer; (d) District Quality Assurance Officer Member. 7. Function of District Council The District Council shall perform the following functions, namely ---- (a) compiling and updating the District Registers of clinical establishment; (b) sending monthly returns for updating the State Register; (e) representing the District in the State Council; (d) publication on annual basis a report on the District of implementation of standards within their respective District. (e) compilation and maintenance of the information and statistics collected from the clinical establiShments under clinical establishment Act. every month. 8. Authority for Registration. (l) The State Government shall, by notification, set-up an authority to be called the District Registering Authority, for each district for registration of clinical establishments, with the following members, namely:— (o) Chief Medicål Officer Chairperson; (b) District Health omeer Member; (2) Notwithstanding anything contained in sub-section (l), for the purposes of provisional registration of clinical establishments under Section 12, the Chief Medical Officer shall exercise the powers of the authority as per procedure, as may be prescribed. 9. District Supervising Team. (l) The State Government shall, by notification, set-up an authority to be called the District Supervising Team for each district, for supervision or clinical establishments, with the following members, namely;— (a) District Health Officer Chairman (b) District Family Welfare Officer Member (e) District Quality Assurance Officer Member (d) Any officer, astime to time Nominated by the CMO ----Member 55 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. CHAPTER IF Registration and Standards for Clinical Establishment. I O_Registration for Clinical Establishment No person shall establish, maintain, manage or earw on any clinical establishment, without being registered under this Act and except under and in accordance with the terms of registration issued. 11. Condition for Registration. (1) For registration or carrying on the clinical establishment, the following conditions shall be fulfilled, namely: i) The minimum standards of ies and services, as may beprescribed, ii) 'ITIe minimum number required personnel* technical or non-teehnieal* as may be prescribed. iii) Provision for maintenance ofreeords and reporGng, asrnay be prescribed, Policy for providing first aid treatment to emergency medical conditions, sexually assaulted, acid victims and Road Tramc Accident cases, and v) Any other matter, as may be prescribed. 12. Application ror Registration. (1) Every person intending to establisll a nevo clinical establishment shall make an application for provisional registration, in such manner and fbrm and with such fee, as may be prescribed, to the District Registering Authority, who on being satisfied about the infbrmation contained in such application, may issue a provisional registration whiéll will remalll valid for Six months, within whiCh period the District Registering Authority shall require the District Supervising Team to make all inspection, who will then after necessary illspeeti011, in such manner, as may be prescribed, sübmit its report to the District Registering Authority; (2) If the District Registering Authority is satisfied that all the required standards and conditions are fulfilled. it may take further action according the procedure prescribed for registration under this chapter: (3) But if the District Registering Authority, on the basis of the report of the District Supervising Team, is satisfied that all the required standards and conditions are not filliilledt he may by order exQnd the period of validity of such provisional registration for a further period of Six months and direct the applicant to take necessary corrective measures within such date and time, as may be specified in that order; (4) If an applicant fails to make necessary corrections, within the extended period also, the applicant •hall be treated as a defaulter for making any application fbr 66 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. registration for a subsequent period of one year, which shall be communicated in writing to the applicant; (5) All applicant, who holds a valid provisional registration and is not declared as a defaulter according to sub-section (4), may make an application for registration, in such manner, form and shall be accompanied by such fee, as may be prescribed; (6) Registration of Clinical establishment issued once sluill be valid for five years in respect of Hospitals and three years in respect of all other categories of Clinical Establishment 011receipt of an application for registration or renewal of the same, the District Registering Authority may require the District Supervising Team to make an inspection, who will then after necessary inspection, in such manner, as may be prescribed, submit its report, to the District Registering Authority and the District Registering Authority, if satisfied that all the required standards and conditions are fulfilled, shall forward the same to the Director, Family Welfare & Preventive Medicine for approval; (7) Aner the approval of the Director, Family Welfare & Preventive Medicine, the District Registering Authority shall issuethe registration; (8) If any application fails to fillfil the criteria during the time of inspection by the District Supervising Team, then the establishment may be given three months more time to fulfil the latches, after which the supervising team will inspect or examine the latches detected during the previous inspection and if any applicant fails in the subsequent inspection also, then his application will betreated ascancelled, but such cancellation will not be a bar for applying for anew provisional registration, with prescribed fee. (9) Notwithstanding anything contained in this chapter, a clinical establishment already holding a valid registration under the Tripura Clinical Establishment Act. 1976, hereby repealed, shall make an application for registration under this Act, on the due date of renewal ofllis registration under the Act, sorepealed. 13. Display of Certificate of Registration. The registration certificate shall be kept amxed in a conspicuous place in the clinical establishment in such manner soasto bevisible to everyone visiting such establishment, 14, Display ofDistrict Registration no. The registration number, provided to the establishment by the District Registering Authority Shallbe displayed in the signboard, advertisement, OPD tickets, IPDtiekets, reports, bills and private prescriptions and any other paper, document or display, by whatever style or manner. 77 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. Duplicate Certificate. In ease the certificate is lost, destroyed, mutilated or damaged, the authority shall issue a duplicate eertifieate on the request of the elinieal establishment and on the payment of such fees asmay be prescribed. 16, Renewål of Registration. The application for renewal of registration shall be reached to the District Registering Authority ninety days before the date of expiry of the vålidity ofthe registration. Provided that, if the application is submitted aner the stipulated time, not later than three months after the expiry of the registration, the application may be considered by the District Registering Authority, subject to the showing of satisfactory reasons for such delay and on the payment of such fine, asmay beprescribed. 17. Cancellation of Registration. (l) If, at any time after any clinical establishment has been registered, the authority is satisfied that, (a) the conditions ofthe registration are not being complied with; or (b) the person entrusted with the management of the clinical establishment has been convicted of an offence punishable under this Act, it may issue anotice to the clinical establishment to show cause within three months' time as to why its registration under this Act should not be cancelled for the reasons to be mentioned in the notice; or (c) ifany government doctors doing private practice in two or more districts or (d) if monthly information & statistics as per if not submitted on due time to the Supervising Authority. (2) If aner giving areasonable opportunity to the elinieal establishment, the authority is satisfied that there has been a breach of any of the provisions of this Act or the rules made thereunder, it may, by an order, without prejudice to any other action that it may take against such clinical establishment, cancel its registration. (3) Every order made under sub-section (2) shall take etTéet— (a) where no appeal has been preferred against suC11order immediately on the expiry ofthe period prescribed for such appeal; and (h) where such appeal has been preferred and it has been dismissed from the date of the order of such dismissal: Provided that the authority, after cancellation of registration for reasons to be recorded in writing, may restrain immediately the clinical establi@hment from carrying on if there is imminent danger to the health and safety of patients. Inspection of Registered Clinical Establishments. (l) Tllie supervising authority or any officer empowered by it in this empowered by it in this behalf may, subject to stib-general or special orders as may be made by the State Government enter and inspect any premises which are used or which the supervising authority or the officer empowered by it has reasonable cause believe to be used for the 88 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. purpose of clinical establishment and inspect records required to be kept in accordance with the provisions of this Act. (2) If any person refuses to allow the supervising authority or the officer empowered by it to enter or inspect any such premises as aforesaid, or to inspect any such records as aforesaid or Obstructs the supervising authority or the officers empowered by it in the execution of the powers under this section, he shall be guilty of an offence under this Act, (3) Nodal Officer of the State (TCE Act) along with the supervising authority of the District or any officer empowered by the supervising authority may randomly inspect the elinieal establishment registered under this Act. 19. Levy of fee by state govermnent. The State Government may Charge fees for different categories of clinical eståbliShments, as may be prescribed. Any fees received or fines paid under this shall be credited to the Consolidated Fund ofthe District through Bank Challan. CHAPTER r Register of Clinical Establishment. 20. Maintenance of State Register. State Council shall maintain a State Register, containing district-wise monthly updated status. within 20mday of thenext month, onthe basisof thereports orthedistricts, in suchformat. asmay be prescribed. 21. Maintenance of District Register. Every District Registering Authority shall maintain a district register containing the updated records OT' all elinieal establishments under their respective jurisdiction, ineluding the infbrmation and statistics, which should be sent to the State Council within 15 day of the next month, in such manner and fOrmat, asmay be prescribed. 22. Maintenance of Clinicål Establishment Register. Every clinical establishment will maintain the updated records of clinical establishments. ineluding such information and statistics, in such manner and format? asmay be prescribed, whiCh Shallbe submitted to the District Registering Authority, within the 07thday of the subsequent month. CHAPTER rl Penalties. 23. Penalty for Non Registration. (1)Whoever contravenes any provision of this Act shall, if no penalty is provided elsewhere, be punishable for the first offence with fine which may extend to ten 99 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. thousand rupees, for any second offence with fine which may extend to fifty thousand rupees and for each subsequent offence with fine which may extend 10five lakh rupees or six months imprisonment or both; (2)No coun inferior to that of a Magistrate of the first class shall try any offence punishable under this Act, 24, Penalty for Disobedience, Obstruction and Refusal of Information. (l) The District Registering Autllority or any other person duly authorized by such authority, within its respective jurisdiction, is empowered to make inspection of ally establishment, at all reasonable time and the Clinical Establishments are liable to show cause for disobedience, obstructi011 and relilsal of information for the first instance; (2) If no reply is received in stipulated time or the reply is not satisfactory, the District Registering Authority, on recording of the reasons of his findings ill writing, shall have the power to impose and realize fine, which may extend to Rs 10,000/3 with the prior approval of the Direelort Family Welfare & Preventive Medicine; (3) If any clinical establishment, doesn't reply to the show cause or fails to pay the fine, within 30 days, the registration of the establishment may be cancelled, with the prior approval of the Director, Family Welfare & Preventive Xledicine, 25 Offences by Government Departments. Where all offence under this Aet has been committed by a Department of Government and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any ofT1cer OTofT1cial, other than the Head of the Department, such officer or official shall also be deemed to beguilty of that offence and shall be liable to beproceeded against and punished accordingly 26. Recovery of Fine. Whoever fails to pay the fine, the Stale Council of clinical establishment may prepare a certificate signed by an officer authorised by it specifying the fine due from such person and send it to the Collector of the District in AV11iehsueh person owns any property or resides or carries on his business and the said Collector, on receipt of such iiicate, shall proceed to recover from such person the amount specified thereunder, as if it were an an-ear of land revenue. CHAPTER J'll Miscellaneous 2Z Protection of action taken in good faith. (4) No suit, prosecution or other legal proceedings shall lie against any authority or any member ofthe National Council or Stale Council or any oilfieer authorized in this 1100 Searchable PDF created by OCR.space (Free Version) TTrripipuruara GGaazzeetttet,e, EExxtrtaroarodirndairynary IIssssuue,e, DDeecceemmbebrer 2200,, 22001188 AA.. DD.. behalf in respect of anything, which is in good faith done or intended to be done in pursuance ofthe provisions of this Act or any rule made thereunder; (2) No suit or other legal proceedings shall lie against a State Government or the Central Government in respect of any loss or damage caused or likely to be caused by anything which is in good faith done or intended to be done in pursuance of the provisions ofthis Act or any rule made thereunder; (3) If any objection or grievance is received by the District Registering Authority, against any establishment, such objections shall be communicated to the clinical establishment, seeking explanation within a period of fifteen days from the date of receipt; (4) If no explanation is received within stipulated time or the explanation is not satisfactory; the District Registering Authority; on recording of the reasons of his findings in writing, shall havethe power to make anenquiry andto take action against such establishment according to the procedures prescribed in this Ael and the rules made thereunder, 28. Repeal and Savings (1) existing Aet entitled " Tripura Clinical Establishment Act, 1976" (Aet No. 12of 1976) in its application to the State of Tripura is hereby repealed; (2) Notwithstanding such repeal, anything done or any action taken or any proceeding instituted or any order made or any notification issued under the Act, so repealed, shall be deemed to have been done, taken, instituted, made or issued under the corresponding provisions of this Act; (3) All reference in any other enactment to any of the provisions of the Acl so repealed shall beconstrued asareference to the corresponding provisions ofthis Act. 29. Power to remove difficullies (l)lf any diffeulty arises in giving effect to the provisions of this Act, after its commencement, the State Government may; by order, published in the official gazette, make such provisions not inconsistent with the provisions of this Act. asmay appear to benecessary for removing the difficulty ; Provided that, no such order shall be made under this section after the expiry of two years from the date of commencement ofthis Act. (2)Every order made under this section, shall belaid* assoon asmay beafter it is made, before the state legislature. JAMATIA LR SECRETARY, LAW GOVERNMENT OF TRIPURA PPrriinntteedd aatt tthhee TTrriippuurraa GGoovveernrnmmenetnt PPrreessss,, AAggaarrtatalala. . 1111 Searchable PDF created by OCR.space (Free Version)