Clinical establishment act

medical

1. CLINICAL ESTABLISHMENT ACT By Dr. S.Vinodhraja pg

2. Objectives Define Clinical Establishments. Classify various levels of Clinical Establishments. Elicit the procedure for registering clinics under Clinical Establishment Act .

3. MCQ 1.Which Clinical establishments not covered under the Act ? Clinic owned by single doctor. Clinics owned, controlled or managed by the Armed Forces. Government medical college. Corporation / municipality – dispensaries.

4. MCQ 2.According to National Sample Survey 60 th round % of the private care is likely being provided by informal unqualified providers? 20% 30% 40% 50%

5. MCQ 3. Tamil Nadu falls under which category of states of CEA 2010? States/UTs where Clinical Establishments Act (CEA) 2010 is applicable. States / UTs which do not have Clinical Establishments Act (CEA) but have their own Act. States which neither have Clinical establishments Act nor their own Act.

6. Introduction The Clinical Establishments Act was passed by Parliament of India on 17 th August 2010 The Act was notified vide Gazette notification dated 28th February, 2012. The Ministry of Health and Family Welfare has notified the National Counci l for Clinical Establishments and the Clinical Establishments (Central Government) Rules , 2012 under this Act vide Gazette notifications dated 19th March, 2012 and 23rd May, 2012 respectively. NSSO estimates, as much as 40% of the private care is likely being provided by informal unqualified providers.

7. Definition Clinical establishments defined as health care establishments by any name, engaged in diagnosis, treatment or care of injury, illness, pregnancy, disability, or abnormality. a clinical establishment owned, controlled or managed by a Government or department of the Government; a trust, whether public or private; a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government; a local authority; and a single doctor ( Exception : establishments of the Armed Forces)

8. Objectives of the Act To establish digital registry of Clinical Establishments at National, State and District level. To prevent quackery by unqualified practitioners by introducing registration system, which is mandatory. To improve quality of health care through standardization of healthcare facilities by prescribing minimum standards of facilities and services for all categories of health care establishments.

9. States category CATEGORY STATES States/UTs* where Clinical Establishments Act (CEA) is Applicable Arunachal Pradesh, Assam, Himachal Pradesh, Bihar, Jharkhand, Sikkim, Uttarakhand, Rajasthan, Andaman & Nicobar Islands, Daman & Diu, Dadra & Nagar Haveli, Puducherry , Mizoram, Chandigarh, Uttar Pradesh, Lakshadweep(16) States / UTs (16) which do not have Clinical Establishments Act (CEA) but have their own Act Andhra Pradesh ,Maharashtra, Delhi, Madhya Pradesh, Manipur, Nagaland, Punjab, Odisha , West Bengal, Karnataka, Jammu&kashmir , Chhattisgarh ,Tamil Nadu , Haryana,Tripura & Meghalaya(16) States which neither have Clinical establishments Act nor their own Act Kerala, Gujarat, Goa

10. Authority National Council for clinical establishments DGHS, Ex-officio, Chairperson 4 elected representatives, out of which Medical Council of India ( one representative), Dental Council of India ( one representative), Nursing Council of India ( one representative), Pharmacy Council of India( one representative), Indian Medicines representing the Ayurveda,Siddha,Unani ( three elected representatives), Central Council of Homoeopathy ( one elected representative) , Indian Medical Association ( one elected representative), Bureau of Indian Standards ( one representative), Association of Indian Systems of Medicines relating to Ayurveda, Siddha,Unani to be nominated by the Central Government ( one representative) Secretary General of the Quality Council of India,

11. At State Level State Council for Clinical Establishments Chairman: Secretary (Health) - IAS Member Secretary : Director of Medical and rural Health Services Members (14): Directors of different streams of Indian Systems of Medicine (3) Elected Representatives of State Councils: Medical Council, Dental Council, Nursing Council, Pharmacy Council, State council of Indian Systems of Medicine (7) Elected representative of State council of IMA, (1) Representative of line of paramedical system (1) State-level consumer groups or reputed Health NGOs (2)

12. AT DISTRICT LEVEL District Registering Authority Chairman: District collector/District Magistrate (DM) Convener: Joint Director Health Services JDHS Three members: to be nominated by DM City Police Commissioner/SSP/SP or nominee Senior officer of local self Government at district level/ DDHS/MHO/CHO Professional medical Association/body IMA,IAP

13. Powers & Responsibilities: DRA Grant/Renew provisional (within 10 days)/permanent registration. List expired Registrations. May issue a notice to Clinical Establishment to show cause within 3 months, if condition(s) of registration are not met To enter and search unregistered CE (after due notice), inspection and inquiry of registered Clinical establishments May cancel registration (after giving reasonable opportunity) and giving reasons After cancelling registration, immediately restrain Clinical Establishment if imminent danger to the health and safety of patients Recover p enalties Maintain District register of Clinical establishments

14. Levels of establishments Levels Clinical establishment Level 1 (A) General Medical services with indoor admission facility ( PHC, Government and Private Hospitals and Nursing Homes run by MBBS /BDS Doctors) Level 1 (B) level 1(A) above and basic specialist medical Services General Medicine, General Surgery, Paediatrics , Obstetrics & Gynaecology and Dentistry. Level 2 (Non-Teaching) level 1(A) and 1(B) and services through other medical specialties ( Orthopaedics,ENT,Ophthalmology,emergency with or without ICU, Anaesthesia , Psychiatry,Skin,Pulmonary Medicine,Rehabilitation .

15. Level 3 (Non-Teaching) Super-specialty services level1(A), 1(B) and 2 and services of one or more or the super specialty with distinct department(Corporate Hospitals, Referral Hospitals, Regional/State Hospital,) Level 4 (Teaching) Tertiary healthcare services

16. Instructions for Creating New Account for Registration TN http://tnhealth.org/dms/tncea/login .Choose the Correct Revenue District. The User ID will be tagged to the Competent Authority of the Concerned District and the Bank Account for Payment of Registration Fee. Verify the presence of your Taluk name in the dropdown for the chosen district. Enter the Name of the Clinical Establishment correctly. This name will appear in the Registration Certificate as it is entered here. Enter Mobile number Enter Valid Email ID. Link for activation of the Login User ID will be sent to this email. Enter the Password of your Choice

17. Minimum required standards Clinic / Polyclinic only Consultation ( level 1A) space : Human Resource: One Doctor – MBBS / BDS registered in any MCI One Support staff – registered in any nursing council Common area Consultation area Reception Waiting Room 35 sqft 35 sqft 70 sqft

18. Furniture/fixtures S.NO Articles 1 Table 2 Chairs 3 Examination Table/couch 4 Screens 5 Foot Step 6 Stools 7 S torage Cabinet for records 8 BMW storage area

19. Essential Equipment Equipment Minimum specification Number Stethoscope 1 Thermometer Digital 1 Torch (flash lights) 1 Sphygmomanometer(B.P. Apparatus) Digital 1 Weighing machine(Optional) Adult 1

20. Emergency Equipment Equipment Minimum specification Number Resuscitation Equipment Ambu Bag/Air Way Adult Pediatric 1 1 Oxygen Concentrator/ Cylinder . Portable 1 Fire Extinguisher 1

21. Emergency Drugs Name of the Drug No of ampule Inj Adrenaline 2 A Inj Hydrocortisone 1 vial Inj Atropine 1 Ampoule Inj Avil 1 Ampoule Inj Phenargan 1 Ampoule Inj. Deryphyline 1 Ampoule Inj. Frusemide 1 Ampoule Inj. Metoclopramide 1 Ampoule

22. Emergency Drugs Name of the Drug No of ampule Inj. Dexamethasone 2 A Inj. Diazepam 1 vial Inj. Dicyclomine Hydrochloride 1 Ampoule Inj. 5% dextrose infusion 1 Vac Inj. Normal saline 1 Vac

23. Penalties under the Act Offences penalties FIRST ATTEMPT SECOND ATTEMPT SUBSEQUENT ATTEMPT Running Clinical Establishment without registration 50,000 2,00,000 5,00,000 Contravention of any other provision of the Act 10,000 50,000 5,00,000 Whoever knowingly serves in an unregistered Clinical Establishment 25,000 Minor deficiencies which do not pose imminent danger 10,000

24. SANITARY AND REGISTRATION CERTIFICATE FROM LOCAL HEALTH AUTHORITY

25. BIO MEDICAL WASTE TREATMENT FACILITY AGREEMENT & AUTHORIZATION

26. Thank you