State of Tamilnadu- Act
Tamil Nadu Clinical Establishments (Regulations) Rules, 2018
TAMILNADU
India
India
Tamil Nadu Clinical Establishments (Regulations) Rules, 2018
Rule TAMIL-NADU-CLINICAL-ESTABLISHMENTS-REGULATIONS-RULES-2018 of 2018
- Published on 1 June 2018
- Commenced on 1 June 2018
- [This is the version of this document from 1 June 2018.]
- [Note: The original publication document is not available and this content could not be verified.]
1. Short title.
- These rules may be called the Tamil Nadu Clinical Establishments (Regulation) Rules, 2018.2. Definitions.
3. Procedure, Quorum and Minutes of State Level Advisory Committee meeting.
4. Procedure, Quorum and Minutes of District Committee meeting.
5. Duties of District Committee.
- In addition to the duties and responsibilities specified in the Act, the District Committee shall also perform the following duties, namely, -6. Minimum facilities of a clinical establishment.
- The floor space and other facilities, the minimum number of staff and their minimum qualification, the minimum equipment and other conditions required for a clinical establishment of different systems, for providing different medical services including specialized services shall be in accordance with the norms and conditions specified in Annexure-I to these rules.7. Application for registration.
8. Certificate of registration.
- On receipt of an application for registration of a clinical establishment, the competent authority shall, after satisfying itself that the applicant fulfils all the requirements of the Act and these rules, grant a Certificate in Form-II within one eighty days from the date of receipt of the application. The Certificate of Registration is non-transferable.9. Time limit for renewal.
- Every application for renewal of Certificate of Registration shall be submitted to the competent authority ninety days before the expiry of its validity.10. Duplicate certificate.
- An application for issue of a duplicate Certificate of Registration shall be made to the competent authority accompanied by a fee for a sum of rupees three hundred.11. Duties of clinical establishment.
- In addition to the duties and responsibilities specified in the Act, every clinical establishment shall, -12. Maintenance of medical records.
- Every clinical establishment shall maintain records with particulars relating to the clinical observation, test, investigation, diagnostic opinion advice and treatment given to the person, who has visited the hospital either as an in-patient or out-patient in Form III.13. Annual Publication of list of clinical establishments.
- The competent authority shall, during the month of January of every year, publish the list of clinical establishments in the Tamil Nadu Government Gazette in Form IV.14. Appeal.
| - Injection Methergin | 5 adenosine monophosphate |
| - Injection Pitocin | 5 adenosine monophosphate |
| - Injection Carboprost | 5 adenosine monophosphate |
| - I.V. Fluids 5% dextrose 2 bottles. | |
| - 5% dextrose or Saline | |
| - Ringer lactate. | |
| - Inj.Diazepam | 2 amp |
| - 2% Lignocane | Vial - 1 |
| - Disposable Syringe | 10 Numbers |
| - Injection Vitamin K | |
| - Injection Eptoin |
1. Buildings. - Sufficient space as the equipment in use demands. Sufficient space shall be provided for patient waiting and resuscitation of the patient in case of any anaphylaxis occurring, during contrast injection or after a treadmill test patient feels like resting. X ray and imaging centres shall fulfil the "Atomic Energy Regulatory Board" (AERB) norms
2. Staff. - All tests shall be carried out by qualified technical persons only as follows:-
| X-Ray - | Radiographer with Clinical Research Associate(CRA) Qualification |
| Ultra Sonogram - | by a qualified Doctor or by a Radiologist orConcerned Specialist as per the provisions of the Pre-ConceptionAnd Pre-Natal Diagnostic Techniques (Prohibition of SexSelection) Act, 1994 |
| Electro Cardiogram (ECG) - | by an Electro Cardiogram (ECG) Techniciantrained in Electro Cardiogram (ECG) taking |
| Electroencephalography (EEG) | Electroencephalography (EEG) Technician trainedin Electroencephalography (EEG) taking |
| Computed Tomography (CT) scan | by a Radiographer and report by a Radiologist orby the concerned specialist. |
| Treadmill | Concerned Technician. A doctor shall be presentduring the Test. |
| Echo Cardiograph | by a Qualified Doctor preferably a Cardiologist |
| Contrast Studies | Radiologist or by the Concerned Specialist |
| Magnetic resonance imaging (MRI) | Radiologist or by the Concerned Specialist |
3. Equipments. - Equipments according to the concerned machine.
4. Records. - Name, age, sex, address of patient, the nature of investigation done referral doctor, and result of the investigation shall be available in a register. Number of cases treated free of charges shall also be available along with name, age, sex, address and result etc.
B. Indian System Of Medicine And HomoeopathyI. Consulting Room / Clinic / Polyclinics1. Building. - The Consulting room shall be spacious, well ventilated and having sufficient light. The space shall be not less than 100 square feet. There shall be sufficient space for waiting of the patients etc., If it is a polyclinic, different cubicles shall be available for each doctor. The names of visiting doctors and their system of medicine shall be exhibited in front of the clinic.
2. Staff. - The clinics namely, Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoepathy Clinics shall be manned by the registered Medical practitioner. If the pharmacy attached with the clinic, dispensing of medicines shall be done by a Pharmacist qualified under the respective system or by the doctor himself.
3. Equipment. - (a) Diagnostic equipments ordinarily needed for all AYUSH, Indian System of Medicine and Homeopathy and Yoga and Naturopathy Clinics:
4. Drugs. - The drugs dispensed to the patients shall contain a label indicating the name of medicine and the name of patient to whom it is given and quantity to be given etc., the date of expiry shall be specified in the label, if the drug has an expiry date. The drug to be given internally and the drug to be used externally shall be indicated and white and red labels to be provided respectively with clear writing as "For Internal use" or " For External Use" in vernacular.,
5. Records. - A record of all patients seen as to their name, age, sex, diagnosis and treatment shall be available. The patient shall be provided with a slip with name, age, sex, diagnosis of treatment given.
II. Nursing Homes And Hospitals. -1. Building. - The norms prescribed for consulting room or outpatient in the Allopathy system of medicine shall be fulfilled. It shall also have sufficient space for patient waiting separate cubicles for each doctors to work. The names of the doctors and then Specialists and different facilities available in the hospital shall be put up in a board.
2. Wards or inpatient rooms. - Inpatient wards shall be spacious with ventilation and lighting. Electric fan shall be provided to each room and in common rooms one fan for at least four beds shall be provided. Toilets be common or separate but shall be clean and provided with water from tap. Cleaning arrangements shall be made to swab daily the wards with antiseptic lotion.
3. Staff. - (a) Doctors. - The hospital shall employ only registered medical practitioner to treat the patients. The doctor shall also be registered in the Council under his respective system of medicine or in the Council/Board for Indian System of Medicine.
4. Equipment. -(a) The following Exercise Therapy equipments shall ordinarily needed for all Siddha Hospitals, namely: -
5. Physical fitness
6. Infrastructure. - Clinic shall have the consultation items and minimum equipments to give out patient treatments. Hospital shall have all the equipments along with diet centre to prepare bland diet, natural diet, herbal juice and other special diet therapy for various diseases. In addition to above, first aid and emergency management need to be provided. Sufficient number of Wheel Chairs, Stretchers shall be available at least one per every thirty beds.
7. Records. - (1) A record of all patients admitted / treated shall be available along with the investigations diagnosis and treatment. The patient shall be provided with a discharge slip containing the details of investigation, diagnosis, treatment and follow up etc.,
1. Communication. - A telephone connection shall be available for use by patients (on payment)
2. Security. - Sufficient security shall be provided for the safety of inmates and to prevent theft.
3. Fire Fighting. - Fire fighting equipment with I.S.I. mark shall be provided as per rules in the hospital.
4. Kitchen. - If food is provided to inmates, the kitchen shall be clean and the cook(s) shall be periodically, medically examined for any infection or contagious diseases.
5. Clothing and Linen. - It shall be clean and changed daily.
6. Water Supply. - The potable water shall be provided to the patient.
7. Waste Disposal. - It shall be as per the Government of India norms and shall follow the guidelines of Tamil Nadu Pollution Control Board.
8. Record Maintenance. - (a) Every Clinical Establishment shall maintain the permanent records pertaining to details of the employees as well as the clinical records pertaining to the patients. The records shall be kept open for inspection by the competent authority or any other officer authorized in this behalf.
| 1 Name of the Clinical Establishment: | 1. Registration No: | ||
| 2. Address: | |||
| Village/Town: | Taluk | ||
| District: | State: | Pincode | |
| Telephone No.(with STD code) | Mobile: | Fax: | |
| Email ID: | Website (if any) | ||
| 3. Year of starting:(From 4 to 11, Mark all whichever is applicable) | |||
| 4. Location: |
| Metro | State Capital | City | Town |
| Notified Area | Village | Any other (Please specify): | |
| 5. Ownership of Services. -Public Sector |
| Central Government | State Government | Local Government (please specify) |
| Public Sector Undertaking | Railways | Employees State Insurance Corporation |
| Autonomous organization | Society/Not for profit Companies | Any other (please specify) |
| Individual Proprietorship | Registered Partnership | Registered Company |
| Corporation (including a society) registeredunder a Central, Provincial or State Act (Please specify) | ||
| Trust (including Charitable) registered under aCentral, Provincial or State Act (please specify) | ||
| Branch of a Foreign Service provider (pleasespecify) | ||
| Any other (please specify) |
6. Name of the owner of Clinical Establishment:
Address:| Village/Town: | Taluk | |
| District: | State: | Pincode |
| Telephone No. (with STD code)Email ID: | Mobile: | Fax: |
7. Name, Designation and Qualification of person-in-charge of the clinical establishment
| Designation: | Qualification: | |
| Address: | ||
| Village/Town: | Taluk | |
| District: | State: | Pincode |
| Telephone No.(with STD code)Email ID: | Mobile: | Fax: |
8. Any other (please specify)
9. Type of clinical establishment :(Please tick whichever is applicable)
Clinic| Single Practitioner | Consulting Room | Polyclinic |
| Dental | ||
| Any other(Please specify) |
| Primary Health Centre | Community Health Centre | Urban Health Centre |
| Dispensary | Day Care Centre | Counselling centre |
| Physiotherapy Centre | Yoga Centre | In Vitro Fertilization (IVF) Centre |
| Dialysis | Hospice Centre | Any other (like Audiometry, Prosthetic & or-thotic etc., (please specify) |
| General Practice Services | Maternity Home |
| Single speciality Services | Multi Speciality Services |
| Super speciality Services | Operation Theatre |
| Emergency Causality | Intensive Care Unit |
| ICCU | Any other please specify |
10. Whether the clinical establishment,-
| Pathology | Haematology | Histopathology |
| Cytology | Genetics | Samples Collection Centre |
| Any other (Please specify) | ||
| Biochemistry | Microbiology | Any other (please specify) |
| Portable X ray | Conventional X Ray | Digital X Ray |
| X Ray with computed Radiography system | Ultrasound | Ultra sound with Color Doppler |
| Mammography | Orthopentogram(OPG) | CT Scan |
| Magnetic Resonance Imaging (MRI) | Positron Emission Tomography (PET) Scan | Bone Densitometry |
| Uro -flowmetry | Any other (Please specify) |
| (A) Based on Location | ||
| Stand alone | Hospital Based | Any other (please specify) |
| Blood bank/Centre having whole blood facilityonly |
| Blood bank/Centre having whole blood andcomponent facility |
| Blood bank/Centre having whole blood and/orcomponent facility with any other additional facility (pleasespecify): |
11. Details of the equipments maintained with :-
System of Medicine12. Services offered (please tick whichever is applicable)
| Medical | Surgical | Obstetrics and Gynecology | Paediatrics |
| Any other please specify |
| Anusadh Chikitsa | Shalya Chikitsa | Shodhan Chikitsa | Rasayana |
| Pathya Vyavastha | Any other please specify |
| Matab | Jarahat | Ilaj-bit-Tadbeer | Hifzan-e-Sehat |
| Any other please specify |
| Maruthuvam | Sirappu Maruthuvam | Varmam Thokknam & Yoga | |
| Any other please specify |
| General HomeopathyAny other please specify |
| External Therapies with natural modalities | Internal Therapies |
| Any other please specify |
| Ashtang Yoga | Any other please specify |
13. Area of the establishment (in square metres)
| (a) Total area: | (b) Constructed Area: |
14. Out-Patient Department
Total number of Out Patient Department Clinics| Sl.No. | Speciality | Number of Rooms |
15. In-Patient Department
| Sl.No. | Speciality | Number of beds |
16. Biomedical Waste Management
| Through Common FacilityAny other (please specify) | Onsite Facility |
| Yes | No | Applied for | Not applicable |
17. Total number of Staff (as on date of application):
| Number of permanent staff: | Number of temporary staff: |
| Category of Staff | Name | Qualification | Registration Number | Nature of Service Temporary/Permanent |
| Doctors | ||||
| Nursing Staff | ||||
| Para-medical Staff | ||||
| Pharmacists | ||||
| Support Staff | ||||
| Others, Please specify | ||||
18. Payment options for Registration Fees:
Demand Draft Treasury receiptAmount (in Rs.)Details:I / We hereby declare that the statement stated above are true and correct to the best of my/our knowledge and I/We shall abide by the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and the Rules made thereunder.Place:Date:Signature of the Authorised person of the clinical establishment.............................................................Acknowledgment:Received Application for Registration from.............................................Signature of the Receiving OfficerName :Date with Seal:Form II(see rule 8)Government of Tamil NaduCertificate of Registration of Clinical EstablishmentRegistration No. (Computer Generated)Date of IssueValid upto :1.
________________________(Name of the clinical establishment) operating from __________________________(Complete Address) as__________________________ (Type of clinical establishment) is hereby registered under the provisions of the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 to provide services under_____________________system of Medicine with______________________(bed strength)2. The Certificate of Registration shall be subject to the conditions laid down in the Tamil Nadu Clinical Establishments (Regulation) Act, 1997 and the Tamil Nadu Clinical Establishments (Regulation) Rules, 2018.
Competent AuthorityPlaceDate:Seal:Form III(see rule 12)Part A – . {|
|-| System of Medicine| Clinical Laboratory:| Tamil Nadu Clinical Establishment RegulationAct Registration no. :|}Register of Laboratory Test ConductedDate| S.No | Name of the Patient and address | Mobile No. | Age | Sex | ID No. | Referring Doctor |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
| 1. | ||||||
| 2. | ||||||
| 3. | ||||||
| 4. | ||||||
| 5. |
| Provisional Diagnosis | Investigations Specimen | Investigation performe | Method of Investigation and Equipment | Result | Additional information if any | Initial of the Medical Officer |
| (8) | (9) | (10) | (11) | (12) | (13) | (14) |
Part B – {|
|-| System of Medicine| Clinical Laboratory:| Tamil Nadu Clinical Establishment RegulationAct Registration no. :|}Date| S.No | Name of the Patient and address | Mobile No. | Age | Sex | ID No. | Referring Doctor |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) |
| 1. | ||||||
| 2. | ||||||
| 3. | ||||||
| 4. | ||||||
| 5. |
| Provisional Diagnosis | Investigations Specimen | Investigation performe | Method of Investigation and Equipment | Result | Additional information if any | Initial of the Medical Officer |
| (8) | (9) | (10) | (11) | (12) | (13) | (14) |
Part C – System of Medicine______Hospital / Nursing Home
Tamil Nadu Clinical Establishment Regulation Act Registration no. :Admission and Discharge Register of Patients| S. No | Name of the Patient and address | Mobile No. | Age | Sex | Hospital IP No. | Date of Admission | Provisional Diagnosis |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) |
| 1. | |||||||
| 2. | |||||||
| 3. | |||||||
| 4. |
| Investigations if any | Final diagnosis | Treatment | Date of Discharge | Result Cured / Same condition / Referred /Expired | Additional information if any | Initial of the medical officer |
| (9) | (10) | (11) | (12) | (13) | (14) | (15) |
2. The hospital shall maintain individual case sheets for the patients
Part D – {|
|-| System of Medicine| Clinic / Consulting Room| Tamil Nadu Clinical Establishment Regulation ActRegistration no.:|-| Name of the Doctor:| xxxxxx||}Register of PatientsDate| Serial No | Name of the Patient and address | Mobile No./ Contact No. if available | Age | Sex | Provisional Diagnosis |
| (1) | (2) | (3) | (4) | (5) | (6) |
| 1. | |||||
| 2. | |||||
| 3. | |||||
| 4. |
| Investigations if any | Final diagnosis | Treatment | Result Cured / Same condition / Referred /Expired | Additional information if any | Initial of the Medical officer |
| (7) | (8) | (9) | (10) | (11) | (12) |
| No | Name of the Patient and address | Mobile No. | Age | Sex | Date of Admission | Hospital IP No. | Provisional Diagnosis | Investi gations if any |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) |
| Operation performed | Operating Surgeon and Assistant | Anaethetist | Staff Nurse Assisted | Operation- Time (From to) | Opration Notes | Transferred to which ward | Additional information if any | Initial of the Medical officer |
| (10) | (11) | (12) | (13) | (14) | (15) | (16) | (17) | (18) |
| Serial No. | Name and Address of Clinical Establishment | TNCERA No. and Date | District | Type of Establishment | Validity Period (6) | |
| From | To | |||||
| (1) | (2) | (3) | (4) | (5) | ||
| 1. | ||||||
| 2. | ||||||
| 3. | ||||||
| 4. | ||||||
| 5. | ||||||
| 6. | ||||||
| 7. |