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State of Tamilnadu - Section

Section 14 in Tamil Nadu Clinical Establishments (Regulations) Rules, 2018

14. Appeal.

(1)An appeal against an order of the competent authority rejecting an application for registration under sub-section (2) of section 4 or an order of suspension or cancellation of registration under sub-section (2) of section 5 or any direction of the competent authority under section 6, shall lie to the Director of Medical and Rural Health Services, within thirty days from the date of receipt of that order or direction.
(2)The Director of Medical and Rural Health Services on receipt of such appeal, if he considers that, an interim order is necessary in the matter, he may pass such an order.
(3)The Director of Medical and Rural Health Services may within sixty days from the date of receipt of such appeal, after giving a reasonable opportunity of being heard, pass such order, as he deems fit.
(4)The decision of the appellate authority shall be communicated to the person concerned within seven days from the date of passing of such order.
(5)The decision of the appellate authority shall be final and binding.Annexure-I(see rule 6)A. Allopathy SystemI. Consulting Room. -
(1)Infrastructure. - Consulting room shall have a space of not less than 100 square feet with sufficient light and ventilation. Separate space for the patients waiting for consultation have also to be provided.
(2)Staff. - The examination of the patient and prescription of the treatment shall be done only by a registered medical practitioner as required under the Indian Medical Council Act.
(3)Equipment. - The following equipment and hospital accessories shall be available in the consulting room, namely: -
(a)Examination couch
(b)Blood Pressure Apparatus
(c)Stethoscope
(d)Torch light
(e)Tongue depressor
(f)Thermometer
(g)Weighing Machine for Adult and Paediatrics
(h)Knee hammer
(i)Measuring tape
(j)Special examination trays like proctoscopy, Pelvic Exam Tray(P.V. Tray), Eye testing screen and Ear Nose Throat examination trays as the case may be, and
(k)Besides screen or sufficient privacy for examination of the patient;
(4)Records. - Every Clinical Establishment shall maintain a register having the details regarding the name, age, sex and address of the patient, date of examination, date of admission. The patient shall be given a slip containing name, age, sex and date of consultation, diagnosis (either provisional or final) and treatment advised, the investigation result shall be entered, if it was undertaken.
(5)Prescription slip. - The Doctor shall sign the prescription slip with date and seal.II. Clinic. - In addition to the norms prescribed for a consulting room, the following norms are required to be fulfilled, namely: -
(1)Building. - Sufficient space for two cots shall be available for keeping the patient under observation in case of anaphylaxis or for giving intravenous drip or for observation etc.,
(2)Staff. - Minimum of a Doctor and a paramedical staff.
(3)Equipments. - (a) Steriliser or autoclave;
(b)Arrangement for getting autoclaved or sterilised syringes / instruments or shall use only disposable syringes;
(c)Sterile Gloves;
(d)Cheetles Forceps;
(e)Scissors surgical;
(f)Adhesive plaster;
(g)Suturing trays with equipment;
(h)Kidney trays;
(i)Surgical equipments for abscess Incision and Drainage etc.; and (j) Drugs.
(4)Waste Disposal. - Facilities to segregate the waste, dressings, etc., as per the Government of India and Tamil Nadu Pollution Control Board norms.
(5)Dispensation of Medicine. - If the clinic is also engaged in dispensing of medicines to the patients, the same shall be done only by a qualified pharmacist or by the doctor of the clinic or under his direct supervision.
(6)Laboratory in a Clinic. - If the clinic is providing laboratory services, the laboratory work shall be done by a qualified Laboratory Technician who holds a Diploma in Medical Lab Technician / Certificate in Medical Lab Technician course approved by the Government or alternately the Medical Officer can get the tests done by trained personnel under his direct supervision. However, urine examination for albumin sugar and blood haemoglobin can be undertaken by a trained person.
(7)X-ray (radiograph). - If the clinic is having its own X-ray unit, the X-rays shall be taken by a qualified radiographer who holds a Clinical Research Associate (CRA) certificate recognized by the Government.
(8)Minor Surgeries. - In case of minor surgeries like cyst excision, Medical Termination of Pregnancy (MTP), Dilation and Curettage (D&C) are under taken it is advisable to have a clean room for the purpose and facilities available as given for minor Operation Theatre shall be provided.III. Polyclinic. - (1) In addition to the norms prescribed for clinic and consulting room, separate cubicles shall be made available to each specialities, if they attend simultaneously.
(2)Waiting room and provision of safe drinking water shall be made available for the patients. Names of different doctors attending shall be exhibited in the waiting room.IV. Hospital. -
(1)Infrastructure. - In addition to the norms prescribed for Clinic, Consulting room and Polyclinic, the waiting room shall be made available for the patients which shall have sufficient space to cater for the number of out patients visiting the hospital.
(2)Wards or in-patient rooms clusters. - (a) Space.- (i) Wards or in-patient rooms shall be spacious with good ventilation and light. Electric fan shall be provided to each room and one fan for at least two beds shall be provided for common rooms.
(ii)Toilets may be common or separate, but shall be clean and provided with water.
(iii)Cleaning arrangements shall be made to swab the wards daily with antiseptic lotion.
(iv)A duty room shall be available for every twenty rooms with necessary Equipment like Oxygen, Saline Stand etc.,
(b)Staff. - (i) Doctors. - One qualified doctor for every thirty beds
- One doctor shall be on call duty up to thirty beds during night and off duty hours.- One duty doctor shall be available in the hospital physically for thirty beds and above in general side for all the 24 hours.- If the hospital is having less than thirty beds, but if an Intensive Care Unit is functioning, then, one doctor shall be available on duty for 24 hours.
(ii)Staff Nurses. - One qualified nurse and two trained nursing assistants shall be available for up to thirty beds in a hospital and then for each additional thirty beds one qualified nurse shall be available.
The aforesaid human resource is the minimum requirement irrespective of the fact the availability of any number of trained personnel working in the hospital.
(iii)Nursing Assistant. - Male and female nursing assistants shall be engaged in sufficient number depending on the bed strength to assist the doctors and nurses in their duties like dressings, enema and preparation of patients for surgery, delivery etc. but they shall not be given the task of giving injections or doing suturing etc. they shall work under the qualified nurse.
(iv)Cleaning Services . - Sufficient number of cleaning personnel (sweeper/sanitary worker) shall be available in the nursing home / hospital. At least one sanitary worker per twenty beds is the minimum requirement.
(3)Other Services. -
(a)Pharmacy. - If a pharmacy is maintained in the hospital for dispensing medicines to the patients, it shall be done by a registered qualified pharmacist only and he should not prescribe any drugs.
(b)Laboratory. - If a Laboratory is maintained by the hospital, other than urine albumin, sugar, blood haemoglobin, all other Laboratory Tests shall be performed by a qualified Laboratory Technician only who holds a minimum of Diploma in Medical Lab Technician / Certificate in Medical Lab Technician.
(c)X-Ray (Radiograph). - X-Ray department shall confirm to the norms prescribed and X-Rays shall be taken by a qualified radiographer with a Clinical Research Associate (CRA) qualification.
(d)Scan. - Ultra sonogram test shall be performed by a Doctor only.
(e)Catering and Canteen. - If catering arrangements are available, the Kitchen shall be clean and the cooks shall be periodically medically examined. Clean practices shall be carried out in the canteen and kitchen.
(f)Blood Bank. - If a blood bank is maintained by a hospital, it shall confirm to the directions issued by the Government of India from time to time.
(g)Ambulance. - It is desirable that, all Hospitals having more than hundred beds shall have an Ambulance with a driver available or alternatively they shall have tie up arrangement with another Hospital having Ambulance or some Ambulance service unit.
(h)General facilities. -
(i)Waste disposal. - Waste disposal shall be as per the Government of India norms and Guidelines issued by Pollution Control Board. Proper segregation of the waste at the point is to be ensured.
(ii)Record Keeping. - (a) A separate record shall be maintained in the form of a register, of all surgical operations, performed in the clinical establishment, which include, among others, the name of the medical practitioner who performed the operation and the name of the anaesthetist in attendance. All patients either discharged or referred to other Hospitals shall be given a discharge advice card / slip.
(b)A medical case record shall be maintained for a period of not less than ten years in the form of a register in the clinical establishment in respect of each patient, which shall include the following particulars, namely: -
(i)a detailed daily statement of the patient's health and condition.
(ii)details of any investigations made, surgical operations carried out and treatment given and
(iii)records of all medical prescriptions, X-Ray reports, laboratory reports or any other report with full name, qualifications of the doctor.
(iv)in the case of a maternity home or a maternity case, the said person shall keep a case record of each child born to a patient. Full and detail record of pregnancy must be maintained for at least a period of ten years.
(iii)Medico Legal Cases. - Every Hospital which treats medico legal cases in accordance with Government Order, all such records and registers pertaining to such cases shall be preserved as per the Government orders from time to time and police shall be intimated regarding their admission, discharge, death etc.,
(4)Mortuary room. - An hospital having more than hundred beds shall have a mortuary room or room with freezer box facilities for the dead bodies.
(5)Water Supply. - Potable water supply shall be made available. Hot water supply also to be provided.
(6)Clothing and Linen. - Bed sheets and other linen used for the patients shall be changed daily.
(7)Fire Fighting. - Fire fighting equipments shall be installed as per rules in force. Only ISI marked equipments to be provided. Adequate precautions against the risk of fire, including provisions for fire escape, fire extinguishers and system of giving warnings and for evacuation of all persons in nursing home or clinic or hospital shall be taken in the event of fire.
(8)Quality Assurance. - The names of the doctors working in the hospital and the facilities made available in the hospital shall be written and exhibited in the hospital. The Hospital shall strive to maintain quality in each of it with the patients.
(9)Communication. - Telephone shall be made available for the communication of the patients with the relative and for referrals.
(10)Security. - Due protective measures shall be under taken by the Hospital to ensure safety of the patients, their properties and to prevent child lifting etc., Every Clinical establishment must exhibit relevant provisions of the Tamil Nadu Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage or Loss to Property) Act, 2008 (Tamil Nadu Act 48 of 2008) in conspicuous places.
(11)Hospital accessories. - Sufficient number of wheel chairs, trolleys, and stretchers shall be made available in the hospital.
(12)Generator. - A generator shall be provided to maintain essential services during power failure.
(13)Labour Room. - If the Hospital is maintaining a labour room and is conducting deliveries it shall have the following norms, namely:-
(a)Building. - There shall be a room for preparation of the patient for delivery, giving enema etc., with sufficient water supply. The Labour room shall be not less than 120 square feet well ventilated with sufficient light. Space for keeping the newborn baby and for its resuscitation is essential.
(b)Staff. - Labour shall be conducted by a qualified Doctor, Staff Nurse, Auxiliary Nurse Midwife or a trained dais. Untrained persons shall not be entrusted with the Job. Even if a Staff Nurse / Auxillary Nurse Midwife conduct the delivery, a doctor shall be on call for any emergency or newborn resuscitation. If the labour ward is in a maternity hospital and deliveries are taking place regularly, a duty doctor shall be available for all the 24 hours. It is desirable to have a Paediatrician on call, wherever possible.
(c)Equipment. - The following equipments and hospital accessories shall be made available, namely:-
(i)Labour Board with lithotomic stand
(ii)Saline Stand
(iii)Oxygen Cylinder with Vent mask
(iv)P.V. Tray with equipment
(v)Dilation & Curettage (C & A) Set
(vi)Focus Lamp
(vii Trolleys for instrument and to receive the baby
(viii)Vaccine extractor / Forceps delivery set
(ix)Sterile core clamp
(x)Antiseptic lotions
(xi)Suction apparatus
(xii)Baby resuscitation set
(xiii)Baby Warmer (a light may also do)
(xiv)Baby mucus sucker (disposable)
(xv)Paediatric ambu bag
(xvi)Suturing tray for episiotomy and suturing.
(d)Drugs. -
- 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  
(e)Records. -
(i)Birth Register
(ii)Birth intimation slip
(iii)Case sheets and notes to be recorded
(iv)Register for babies and mothers to prevent child changing.
(14)Operation Theatre. -
(a)Minor Operation Theatre. - Where septic cases and minor surgeries like abscess, Incision and Drainage (I&D) and septic cases like amputations etc., are carried out.
(i)Space. - Sufficient space - not less than 100 square feet with adequate lighting and ventilation.
(ii)Staff. - All surgeries in minor operation theatre shall be carried out by qualified doctor only. However dressings can be done by a Nurse or a Nursing Assistant.
(iii)Equipments. - Operation table.
- Focus light- Sterilizer- Auto clave- Bins- Saline Stand- Minor surgical equipments- Regional Anaesthesia equipment- Sterile gloves- Sterile syringes- Drugs as required- Drugs for emergency tray- Boyle's apparatus with Oxygen cylinder, Nitrous Oxide Cylinder (Desirable)- Suction apparatus- Baby resuscitation set
(iv)Records. - Records of all surgeries done in minor operation theatre shall be entered in a register.
(b)Main Operation Theatre. -
(i)Space. - Shall have sufficient space with a minimum of 150 square feet is essential, well lit preferably air-conditioned. Other than the operating room, there shall be provision for patient waiting and a cot provided for postoperative recovery. Sufficient space shall be available for autoclave and sterilization and for scrubbing. Running water from the tap shall be available in the scrub room. Ultra violet lamps shall be fitted in the operation theatre. Sufficient arrangements for formalisation of operation theatre. Swab for culture to be taken from operation theatre at least once a month.
(ii)Staff. - A qualified nurse shall be the head of nursing staff in the Operation Theatre. Anaesthesia to be provided by a qualified Anaesthetist or by a doctor only who is trained in anaesthesia. Surgeries shall be performed by qualified doctors only.
(iii)Equipments. - Operating table
- Focus Light preferably wall mounted- Boyle's apparatus with sufficient cylinders- Monitoring devices like
(a)Cardiac monitor - must
(b)Pulse Oximeters - must
- Suction apparatus preferably two- Sterilizer, Autoclave- Surgical equipments for surgery- Sterile bin- Stretcher for shifting of patient- Anaesthesia Kit.
(iv)Records. - Record of all surgeries performed shall be available in a register duly with name, age, sex, address of patient, Surgeon, Anaesthetist and Staff Nurse also to be entered. Biopsy reports also shall be entered.
(15)Intensive Care Unit. - An Intensive Care Unit may be maintained in all Nursing Homes / Hospital having more than hundred beds. The following norms are to be maintained, namely:-
(a)Space. - A well ventilated preferably air conditioned room with sufficient lighting is essential. If four Cots are there, a minimum space of 240 square feet is needed. Sufficient space for keeping ventilators and monitors to be available. Space for duty doctor and nurse shall also be available. There shall be provision for attendants outside the Intensive Care Unit.
(b)Staff. - One doctor for every ten beds for day time. If there are more than ten beds, one additional doctor for every additional five beds. Similar provision shall be made for night time.
(c)Nurse. - One qualified nurse for up to six beds for day time. An another qualified nurse for every additional three beds.
This similar arrangement shall be made for night time.
(d)Equipments. -
- Intensive Care Unit Cots- Saline Stands- Ventilators- Cardiac Monitor- Pulse Oximeter- Defibrillator- Suction apparatus- Oxygen supply (either Cylinder or central supply)- Incubation equipments- Drugs- Generator
(e)Records. - A record of in-patients in Intensive Care Unit shall be available in a register as to their illness, treatment offered, specialists visited - Out come etc.,
(16)Medical Record Maintenance in a Hospital. - The following records shall be maintained, namely:-
(i)Admission and Discharge Register.
(ii)Case sheets
(iii)Referrals
(iv)Infectious and Communicable disease Register.
(v)Immunisation particulars
(vi)Family Welfare Services
(vii)Medico Legal Records
(viii)Maternal Death Record
(ix)Infant Death record
(x)1 to 5 years Child Death records
(xi)any other record as may be required by the Government, from time to time.
V. Maternity Hospitals. - In addition to facilities/ Norms specified for Nursing Homes / Hospitals, a labour room and an operation theatre is preferable facilities for transport of patients like an Ambulance or tie up arrangement with a Central Ambulance Service is desirable.VI. Dental Clinic. - (1) Building. - The consulting room if it accommodates the Dental Chair also shall be having sufficient space not less than 100 square feet. The room shall be well ventilated and shall have sufficient lighting arrangements. Space for keeping the Sterilizer and Trays to be provided. Sufficient space for patient waiting to be provided outside the consulting room.
(2)Staff. - Dental Surgery, Consultation and prescription shall be performed by a qualified Dental Surgeon only as per the Indian Dentist Act, 1948 (Central Act XVI of 1948). Injections and administration of anaesthesia shall be done by the dental surgeon himself. X-Ray shall be taken by a qualified Radiographer or by the Dentist.
(3)Equipments. - (a) Dental Chair
(b)Provision of water for surgery
(c)Steriliser
(d)Bin for sterile cotton gauze etc.
(e)Trays with instruments
(f)Dental instruments
(g)X-Ray (desirable)
(h)Disposable (optional) / autoclaved syringes.
(4)Records. - A record of the patients treated along with name, age, sex, disease and treatment given shall be available. A slip shall be given to the patient with all the above particulars.VII . Dental Hospitals. - Out-patient department. - The outpatient department of a dental hospital shall confirm to the norms prescribed to a Dental Clinic. In addition, sufficient waiting room shall be provided to the patients. Wards, Operation Theatre and other aspects shall be as per the norms prescribed to the nursing homes and hospitals.VIII. Clinical Laboratories. - They shall include clinical laboratories, pathological laboratories, genetic laboratories etc.
(1)Building. - A minimum of space for sample collection, First Aid Room, Processing, Report preparation etc., 500 Square feet in Rural, 700-1500 Square feet in Urban should be available. There shall be lavatories for the patients use at least one shall be available with sufficient water. There shall be sufficient space for Microscopy and for Biochemical tests. The room shall be well ventilated with sufficient light. Space for keeping a cot for the use of patient shall be available. If x ray is also functioning norms as for an X ray centre shall be followed. The laboratories shall ensure adequate space in relation to the following:-
(a)Patient's reception
(b)Sample collection
(c)Isolation for Bio hazardous materials
(d)Radioisotope related work as per the regulatory agency Atomic Energy Regulatory Board (AERB) requirement.
The Laboratories shall ensure standards prescribed by the National Accreditation Board for Testing and Calibration of Laboratories for the personal, qualification etc., Quality assurance in Lab Service, Internal Quality and External Quality should be ensured.
(2)Staff. - (a) The Biopsy examination and reporting shall be done by a Pathologist or by a Trained Doctor. When culture and sensitivity tests are carried out, a Microbiologist either Medical or non-Medical shall be available, Cytology reports shall be given by a Pathologist only.
(b)Qualification for technical staff. - The staff performing the technical tests shall have the following qualifications, namely:-
(i)Graduate in Medical laboratory Technology; or
(ii)Two years Diploma course in Medical Laboratory Technology; or
(iii)One year Certificate course in Medical Laboratory Technology with two years experience; or
(iv)Graduate in science with one year experience in Medical Laboratory; or
(v)Diploma in medical radiation and radioisotope technology (DMRIT) ; or
(vi)Certificate in Cytotechnology by Indian Academy of Cytology for screening of ex-follative cytology in addition to the above qualification for Cytotechnologist.
(c)In a genetic laboratory, all tests shall be carried out and reporting done by a qualified Genetist or qualified doctor only. If amniocentesis is done as permitted by law it shall be done only in a Minor Operation Theatre and all facilities as needed for a Minor Operation Theatre shall be available and it shall be done by a qualified doctor under sterile conditions only.
(3)Equipments. -
(a)Microscopes
(b)Calorimeter
(c)Centrifuge
(d)Test Tubes
(e)Slides
(f)Reagent as needed
(g)Semi Auto Analyser or Auto Analyser (Optional)
(h)Cell Counter (Optional)
(i)Haemoglobin meter
(j)Counting Chambers etc.
(k)Refrigerator
(l)Hot Air oven
(m)Physical Balance
(n)Micro Puppets fixed and variable volume.
(4)Records. - All tests carried out on the Laboratory shall be recorded in a Register along with name, age, sex, investigation done report, date, etc.,The following minimum Records to be maintained: -
(a)Daily Results Register
(b)Internal Quality Control Register
(c)Sample Collection Register
(d)Participation in External Quality Assessment Schemes Programmes.
IX. X-Ray (Radiograph) Centres. - This Centre shall include all centres of Imaging, Sciences namely, Ultra Sonogram Scan Centres, Computed Tomography (C.T.) Scan Centres, Magnetic resonance imaging (MRI) Scan Centres, X-Rays (Radiograph) as well as Electro Cardiogram (ECG), Electroencephalography (EEG) and Treadmill Echocardiography.