I
Standards for Building and Accommodation[See rule 5]Part I – General
1. Introduction. - 1.1. The clinical establishment should maintain the Building and Accommodation standards and norms as specified in this schedule or any such standards and norms as may be notified from time to time.
1.2The use of the premises should conform to the land use prescribed under relevant Acts, rules and bye-laws of the concerned local authorities as in force and other relevant Acts and rules.1.3No person, other than on-duty service providers should be allowed to reside in the premises except with the special permission of the Licensee. No person should be allowed to sleep on the floor where the patients are accommodated.1.4All the rooms, wards operation theatres, labour room, special care areas, out-patient department and diagnostic departments should be easily approachable by stretcher and a wheel chair. As much privacy should be provided to the patients as possible. A telephone with landline connection is a must for every clinical establishment. There should be adequate provision for adequate parking facilities for staffs and visitors in case of clinical establishment with 100 or more beds.1.5All clinical establishments should be well ventilated, illuminated with uninterrupted power supply arrangement. All clinical establishments should follow the minimum space requirement mentioned in the table annexed with. The space requirement of Diagnostic Imaging should be as per AERB guideline1.6The basement, if any, should be used with caution as per Fire safety Act and no patient should be received or accommodated there.1.7The clinical establishment should have adequate space devoted to stairs, ramps, corridor for internal transportation of the patients on wheel chairs, trolleys etc.1.8The building should conform to such Building Engineering Environmental Standards as may be notified.Part II – Specific :
1. Outpatient based Facilities. - 1.1. Outpatient based Facilities should be provided with (a) The Reception and Information area for providing information to the patients and party; (b) Waiting area with adequate and comfortable seating arrangements for the patients and their attendants. It should be provided with (i) drinking water facilities adjoining to waiting area and (ii) toilet and wash rooms (separate for male and female)
1.2Depending upon the type and number of specialties being offered, the clinical establishment should be provided with consultation-cum-examination room /cubicles to run OPD clinics of different types like Medicine, surgery, obstetrics & Gynaecology etc.2. Inpatient based Facilities. - 2.1. Nursing Homes : Provisions for OPDs, Indoor, operation theatres, ICUs, Labour room etc. should be provided depending upon the type of facilities being offered. Nursing Homes should have their own Laboratory and Diagnostic (X-ray, Ultrasound etc.) facilities which should be established as per the norms indicated against such facilities or should have working arrangements with Laboratories, Blood Bank and other diagnostic centres. In case of Hospital or Nursing homes having 100 or more beds, it should have provision for emergency laboratory tests and mobile X-ray machine for emergency X- ray.
2.2Casualty and emergency care area : It should be as per norms as may be notified2.3Maternity Homes : All Nursing/Maternity Homes taking care of Obstetrics patients should be able to carry out procedures like suction and evacuation, dilatation and curettage, Lower Segment Cesarean Section and Hysterectomy on an emergency basis. It should provide proper arrangement for Blood transfusion facilities. Such Nursing/ Maternity Homes should have facilities for new born care corner and Neonatal Stabilization Unit as per IPHS norm. Where obstetric services are given, new born care corner should be provided. It should have Operating suite and Delivery suite as per norms. In maternity homes an arrangement should be provided to isolate a patient of eclampsia.2.4Space requirements : Inpatient based Facilities have been divided into following categories: (a) Entrance area; (b) Ambulatory area; (c) Diagnostic area; (d) Intermediate area; (e) Critical care area; and (f) Service area.2.5Entrance area : It should have the separate public areas earmarked for (a) reception and information, (b) registration and record keeping; (c) waiting area; (d) water and toilet facilities area. Registration area should be located near the entrance provided with a counter with facility of drawers etc. The area and the number of desks will depend upon patient load. Record keeping room/area should be suitably located with adequate space.2.6Ambulatory area : In the outpatient department should be located such that patients visiting the outpatient department need not pass through inpatient areas. Depending upon the type and number of specialties being offered, the Nursing Home should have consultation-cum-examination room /cubicles to run OPD clinics of different types like Medicine, surgery, Obstetrics and Gynaecology etc. The ambulatory zone should have the following rooms in addition to the consultation room: (a) Treatment and dressing room (b) Nursing station for OPD block with clean and dirty utility room.2.7Diagnostic area : Facility like Pathology Lab, if any, should ideally be interposed between OPD and IPD and should follow the standards as described in Part IV of this schedule. Facility like X-Ray and ultrasound, if any, should be so located to serve both indoor and outdoor patients and should follow the standards as described in Part V of this schedule. The room housing diagnostic X-Ray units, including CT scan and related equipments should be located as far away as feasible from areas of high occupancy and general traffic, such as maternity and pediatrics wards and other departments of the hospital that are not directly related to radiation and its use.2.8Intermediate area : It should be consisting mainly of inpatient nursing units and wards, toilet rooms, closet, lockers, ward robes, etc. The indoor blocks should be located away from the main roads and OPD area to avoid disturbances and the cross infection. The beds should be laid out in such a way as to make the patient accessible for treatment from either side. In wards, visual privacy should be provided for each patient according to the need and adequate space as per norms should be available. Separate ward units should be provided for male and female patients. Admission should be restricted to the number of beds to be maintained.2.8.2. Patients with infectious diseases should not be admitted into general wards. Every patient should have access to a toilet area without having to enter the general corridor area. The ward should have the facilities for (a) Nursing station (including work area, space for cabinets, medicine trolley, refrigerator etc.) (b) Treatment room (c) Ward store (d) Emergency Trolley (e) Patients' toilet (f) Space for pantry for collection and distribution of meals.2.8.3. A Sluice Room (one per ward) meant for emptying and cleaning bed pans, urine bottles and sputum mugs, disposing of used dressing and similar material, storage of stool and urine specimens, cleaning mackintoshes/rubber sheets should be provided.2.9Service area : All nursing homes providing dietary services should have: (a) Cooking area (b) Washing area; (c) Garbage collection; (d) Dry ration storage area. The Nursing home should have (a) General store/linen store; (b) Medical records room (c) Administrator and nursing-in-charge office; (d) Nurses changing/duty room with toilet (e) Doctors' duty room with toilet.2.9.2. The drug and medical supplies stock should be properly maintained. The drug storage cabinets, shelves, refrigeration facilities for keeping the vaccines and other drugs in controlled temperature should be provided. If it has a Pharmacy, it should be ideally so located that it serves both inpatient and outpatients. Regarding storage, handling and usage of medical supplies, the clinical establishment shall follow the provisions of the Drugs and Cosmetics Act, 1940 [Act 23 of 1940].2.9.3. The nursing home should have generator/back-up power source so that in case of a power failure, all equipments, instruments and electrical points of the nursing home (including those for refrigerator, fans, lights) can be able to work as normal. The capacity of generator required should be accordingly calculated. It should be installed in a place where it will not disturb patients and traffic.2.9.4. Additionally, the Nursing home should have (a) Space for storage of oxygen cylinders; (b) Nitrous oxide cylinders. Enough reserve cylinders should be stored to complete at least one day's procedures.2.10Critical Area : This area is required in surgical and maternity homes. This area consists of the Operating Suite and Delivery Suite. This is technically a therapeutic aid in which a team of surgeons, anaesthetists, nurses, gynecologists and sometimes pathologist/s and radiologist/s operate upon or care for the patient. The critical area should be located and arranged to prevent general traffic through the suites. When delivery and operating rooms are in the same suite, access and service arrangements should be such that neither staff nor patients need to travel through one area to reach the other.2.10.2. If outpatient surgery (i.e. surgery which is performed without anticipation of overnight patient care) is to be integrated with hospital inpatient surgery, at least one room should be specifically designated for outpatients to change from street clothing to hospital gowns and to prepare for surgery.2.10.3. Room for post anesthesia recovery of outpatient surgical patients should be provided. Depending on the patient load, this room may also serve the purpose of a supervised 'recovery lounge' for patients who do not require post anaesthesia recovery but need additional time for their vital signs to stabilize before safely leaving the facility. Such a room should have an area of at least 180 sq.ft. It should be provided with two cots, have convenient access to toilets large enough to accommodate a patient and an assistant, space for one or two family members, provisions for privacy and a small space which can serve as a nurses counter.2.10.4. Operating suite is divided into: (a) Clean Zone, (b) Protective Zone (c) Aseptic or sterile zone (d) Recovery room (e) Disposal zone2.10.4.1. Clean Zone : This includes the recovery room. It is principally the corridor linking the transfer bay to the theatre suite. Patients are brought from the ward and should not cross this zone in their ward- clothing which is a great source of infection. Changeover of trolley should be affected just before the clean zone. All staff should enter from a separate route and through a set of change rooms and through an air lock. They should communicate with the sterile corridor. A shoe change and gowning space near the air lock should be provided.2.10.4.2. Protective Zone : (i) Nursing Station with storage facility (sterile); (ii) changing rooms with toilet, staff arrive through this zone and proceed via changing areas dressed for their task2.10.4.3. Aseptic or sterile zone : It consists of (i) operation theatres, (ii) Instrument sterilization, (iii) theatre pack preparation and sterile storage, (iv) scrub up and gowning rooms. In the theatres to ensure the minimum risk of infection to the patients, fortnightly bacteriological sampling should be carried out from registered Lab. and reports maintained for inspection on demand.2.10.4.4. Disposal zone : Also erroneously called the dirty zone. Soiled instruments and dressings are transacted through this area for washing, decontamination and sterilization or disposal.3. Special Care Units. - 3.1. The beds should be laid out in such a way as to permit observation of every patient from the nursing station. When patients are provided with privacy and are kept in different enclosures a central monitoring station is a must. There should be adequate moving and working space around the beds.
3.2These units should be declared as restricted area and access to such units should be regulated. It should be on the same floor as the OTs and recovery ward. Adequate attention should be paid towards asepsis. The noise level should not be above 50 db.3.3In a room divided for each patient with curtains to provide privacy to the patients of three sides with a screen up to an acceptable height of 8 ft.3.4The Heating, Ventilation and Air-conditioning (HVAC) system of ICU should be as per norms:3.4.1. The ICU should be fully air-conditioned which allows control of temperature, humidity and air change. Suitable and safe air quality should be maintained at all times. Air movement should always be from clean to dirty areas. It is recommended to have a minimum of six total air changes per room per hour, with two air changes per hour composed of outside air.3.4.2. The dirty utility, sluice and laboratory need five changes per hour, but two per hour are sufficient for other staff areas. Central air-conditioning systems and re-circulated air should pass through appropriate filters.3.4.3. It is recommended that all air should be filtered to 99% efficiency down to 5 microns. Smoking should not be allowed in the ICU complex. Temperature should be maintained with an emphasis on the comfort of the patients and the ICU personnel.3.4.4. For critical care units having enclosed patient modules, the temperature should be adjustable within each module to allow a choice of temperatures from 16 to 25 degrees Celsius. Temp. should be 21 deg C (for adult), 24 deg C (for child) and humidity 50-60%.3.4.5. A few cubicles may have a choice of positive or negative operating pressures (relative to the open area). Cubicles usually act as isolation facilities, and their lobby areas should be appropriately ventilated in line with the function of an isolation area (i.e. pressure should lie between that in the multi-bed area and the side ward).3.5The ICU should have its own power backup, which should start automatically in the event of a power failure. This power should be sufficient to maintain temperature and run the ICU equipment (even though most of the essential ICU equipment has a battery backup). Voltage stabilization is also mandatory. An Uninterrupted Power Supply (UPS) system is preferred for the ICU.4. Pathology Laboratory Facilities. - 4.1. The basic infrastructure facilities include 4 areas: (a) Reception/waiting room/area where requisition forms are received and reports disbursed along with toilets, facilities for disabled persons, toilet for staff; (b) Specimen collection room/area, with privacy for special purposes eg. semen collection
4.2In case a specialized Lab, following room/space should be provided: (a) Histopathology : (i) Gross room and specimen preservation room/space; (ii) Processing and block making, sectioning and staining room/space (b) Immunohistochemistry: FNAC room with bed.4.3It should have (a) Uninterrupted power supply; (b) Specimen/Sample/slide storage facility including cold storage where applicable; (c) Facility for cleaning of glassware, sterilization / disinfection and (d) Separate facilities/area for staff for hand washing, refreshment and storing food, drinks etc.4.4Equipment should be suitably located in the laboratory so as to allow accessibility and sequential utilization thus minimizing the need for frequent movement of specimens or reagents. Additional infrastructure facilities may be added for special tasks as and when needed.4.5The collection center should have an adequate waiting space and a room having floor area mentioned in table below. No collection center should be operated by any pathological laboratory in any medicine shop. If any laboratory is found to operate through a medicine shop the authority may cancel the license of such laboratory.5. Table : Standard measurements for clinical establishments
| |
Item |
Measurements(minimum floor area) |
| (1) |
Additional Reception/waiting area for clinic/lab |
60 sq.ft. |
| (2) |
General consultation-cum-examination room/cubicles
|
100 sq.ft. |
| (3) |
Eye / ENT /Ortho/Otherconsultation-cum-examination room /cubicles
|
140 sq.ft. with equipment |
| (4) |
Audiometery Room |
120 sq.ft. |
| (5) |
Refraction/ perimetry/ Tonography/ slit lampRoom
|
160 sq.ft. |
| (6) |
Physiotherapy clinic |
180 sq.ft. |
| (7) |
Wellness/Fitness clinic |
180 sq.ft. |
| (8) |
Dental clinic area per dental chair |
140 sq.ft |
| (9) |
Space per bed in general ward |
65 sq.ft. |
| (10) |
Space per bed in Critical care unit |
120 sq.ft. |
| (11) |
Distance between centre of 2 beds |
6 ft. |
| (12) |
Distance between bed and wall |
1 ft |
| (13) |
Width of a door in a ward |
3 ft. |
| (14) |
Toilet |
36 sq.ft. |
| (15) |
General operation theatre area per table |
160 sq.ft. (withadditional100 sq.ft. per additional table).
|
| (16) |
CTVS and Neurosurgery operation theatre area pertable
|
500 sq.ft. |
| (17) |
Area for instrument sterilization |
50 sq.ft. |
| (18) |
Area for scrub up |
25 sq.ft. |
| (19) |
Area for dirty wash |
25 sq.ft. |
| (20) |
Area for pantry |
80 sq.ft. |
| (21) |
Area for Observation room with 1 bed |
As above for 1 bed in ward |
| (22) |
Area for nursing station |
120 sq.ft. |
| (23) |
Area for RMO's room including toilet |
150 sq.ft. |
| (24) |
Delivery room with 2 tables including NBCC of 50sq.ft
|
170 sq.ft. (withadditional60 sq.ft. per additional table).
|
| (25) |
Collection centre |
80 sq.ft |
| (26) |
Small laboratory |
160 sq.ft. |
| (27) |
Medium laboratory |
200 sq.ft. |
| (28) |
Large Laboratory |
240 sq.ft. |
| (29) |
X Ray lab with dark room facility |
270 sq.ft. |
| (30) |
USG lab |
120 sq.ft. |
| (31) |
TMT Lab |
120 sq.ft |
| (32) |
ECG Lab |
80 sq.ft |
| (33) |
Medicine store of Nursing/maternity home |
90 sq.ft |
| (34) |
Any other space not mentioned above |
240 sq.ft |
II
Standards for Service Provider[See rule 6 and 7]Part I – General
1. Introduction. - 1.1. The clinical establishment should maintain the Service Provider standards and norms as specified in this schedule or any such standards and norms as may be notified from time to time.
1.2Unless mentioned otherwise by the applicant, all staff requirement should be calculated on the basis of a routine 3 shift arrangement along with adequate number of reserve staff.1.3All the medical, nursing and paramedical /allied-medical professional of the clinical establishment who are already registered with councils of other state should be registered with the respective councils of West Bengal within 90 days of commencement of this rule within a reasonable period of time as notified by the concerned authorities. If there is no such council in the state of West Bengal, registration certificate awarded by such councils of other state or All India Council may be considered as valid for the purpose of this act. They should have adequate communication skill and should be able to speak in Bengali (and Nepali in GTA area).1.4No staff on shift duty should be on-duty for more than 12 continuous hours in a day (24 hour period) so that every staff remains reasonably alert, attentive and energetic enough to respond to all needs of a patient.2. Medical Staff. - 2.1. In case of specialized service, it should have at least one registered medical practitioner of modern medicine having minimum qualification of a post-graduate diploma/degree/certificate in relevant discipline to supervise/perform/conduct the test/procedure, to interpret and give the result or to examine and advice. Illustration. (a) One Ophthalmologist in case of eye clinic; (b) One dental surgeon in case of Dental clinic; (c) one Radiologist in case of X-Ray lab; (d) One sonologist/radiologist in case of Ultrasonography lab etc.
2.2There should be one registered medical practitioners available on duty at each consultation room of the OPD clinic during the OPD hours to ensure the availability of services as notified in the mandatory display by the clinical establishment.2.3IPD facilities should have two kinds of Medical staff or doctors: (a) Consultants and (b) Resident Medical Officers (RMO). As soon as a patient arrives at a clinical establishment he or she should immediately be attended by a Resident Medical Officer or consultant.2.4If it is medically necessary, the Primary Consultant may refer the patient to another Registered medical Practitioner who should be asked to render her opinion or advice or to perform a particular procedure in her capacity of being a Consultant having specialized knowledge, skill, expertise or experience.2.5There should be at least one doctor to act as Resident Medical Officer (RMO), in case of a Maternity/nursing home, available on duty round the clock for every 15 Patients or 15 beds or a fraction thereof. To ensure such availability, the clinical establishment should engage adequate number of reserve staff also.Illustration: A twenty bedded Nursing home without any special care units with a 3-shifts arrangement should have at least 2 x 3 that is 6 Resident Medical Officers (RMO) plus reserve.2.6In case of nursing home with OT facilities, at least one Resident Medical Officer (RMO) or one consultant should be available to assist the consultant-surgeon which conducting any major operation. In case of maternity home, every delivery should be conducted /supervised by a Resident Medical Officer (RMO) or one consultant- obstetrician and every delivery case of high-risk pregnancy/ fetal distress should be attended by a pediatrician.2.7In addition to the Resident Medical Officer (RMO), the number of consultant required in the Inpatient based Facilities should depend upon type of the services being provided (general /specialty/super-speciality etc) there.Illustration. A nursing home providing medical facilities should have a consultant-physician available on call round the clock. A nursing home providing surgical facilities should have a consultant-surgeon and anesthetist available on call round the clock..Illustration. The resuscitation of new born should be under the supervision of a trained Registered Medical Practitioner. Maternity home should have gynecologist /surgeon, anesthetist, and pediatrician on call.3. Nursing staff. - 3.1. There should be one qualified registered Nursing Staff, in case of a Nursing Home, or one qualified Nursing staff/ Midwife in case of a Maternity Home available on duty round the clock for every 5 patients or 5 beds if on same floor or a fraction thereof and if on different floors then in same proportion on different floors.
Illustration. A twenty bedded Nursing home without any special care units with a 3-shifts arrangement should have at least 4 x 3 that is 12 Nurses plus reserve.3.2There should be at least one qualified (at least GNM) nurse on duty round the clock per labor /OT table. The nurses for operation theatres and special care units need additional training/experience/expertise.3.3One of the senior nursing staff should be entrusted with the sterilization and should act as Delivery suite/OT suite in-charge.4. Allied- Medical /Paramedical Staff. - 4.1. Depending upon the nature of service offered by the clinical establishment and the expected workload, at least one on-duty qualified Allied-Medical or paramedical professional should be engaged.
Illustration.; (a) physiotherapist in case of physiotherapy clinic; (b) Medical Technician/Technologist (Lab) in case of Pathology lab; (c) Medical Technician/Technologist (X-Ray) in case X-Ray lab etc.4.2With effect from such notified date, the clinical establishment shall provide for Minimum One OT technician, One Anaesthesia Technician in per OT and other such type and number of Allied-Medical or paramedical professional as may be notified4.3No paramedical or Allied-Medical professional should run the establishment or practice his profession without the direction or supervision of a registered medical/dental practitioner.Illustration. In case of physiotherapy clinic, it should be under the direction or supervision of a registered medial practitioner.5. Healthcare Assistant/attendant and Sweeper. - 5.1. Depending upon the nature of service offered by the clinical establishment and the expected workload, at least one on-duty qualified Healthcare Assistant/attendant should be engaged.
Illustration 1. Each OPD clinic or laboratory should have at least one helping hand General Duty Attendant (preferably female). There should be at least one General Duty Attendant (Female) for obstetrics and gynaecology OPD; one GDA for surgical and medical OPD.Illustration 2. In case of all inpatient based facilities, there should be (a) at least one Bedside Attendant, available round the clock for every 10 Patients or 10 beds or a fraction thereof, in every eight hour shift; (b) at least one Midwifery Assistant (Female) for labour room available round the clock; one Healthcare Assistant/attendant for O.T. suite available round the clock; (c) at least one sweeper 10 Patients or 10 beds or a fraction thereof, in every 8 hour shift and One sweeper for operation theatre and Labour ward.5.2With effect from such date, the clinical establishment shall provide for such type and number of Healthcare Assistant/ attendant having such qualification as may be notified.6. Administrative-Managerial staff. - 6.1. This category of staff includes - Managers, receptionists, supervisors, security personnel etc. The requirement of this category of staff depends solely on the type of a hospital and its size. As the size of a hospital increases the need for this category of staff also increases proportionately. Such staff should be provided in such number to the satisfaction of the Licensing Authority.
6.2Administrative-Managerial staff should be available at the Inpatient based Facilities with 100 or more beds as per following norms: (a) One Manager/Administrator/Chief executive Officer; (b) One Receptionist (shift duty); (c) One Cashier; (d) One Medical Record Keeper; (e) One Storekeeper.7. Non-Medical technical staff. - Depending upon the type of facilities being offered, extent of outsourcing etc, support staff like Cook, Plumber, Electrician, Telephone operator, Central heating/AC operators, Driver etc. should be at the disposal of the clinical establishment.
Part II – Specific : 1. ICU. - 1.1. In case of nursing homes providing special care unit facilities, there should be at least two resident medical officers exclusively for Critical care having post graduate diploma or degree or adequate working experience at a recognized hospital in the concerned discipline.
2. In case of nursing homes providing special care unit facilities, there should be adequate number of nursing staff exclusively for critical care having certificate, diploma or degree or adequate working experience at a recognized hospital in the concerned discipline.
1.3There should be one trained nurse available round the clock for every 3 beds in such special care units including post-operative wards. There should be one qualified critical care Technician available round the clock in such special care units.2. Eye Clinic with operating facility. - Eye Clinic with operating facility should have (a) Doctors with post graduation in ophthalmology, (b) minimum of two nurses for 10 beds and supportive staff preferably qualified O.T Technician. Service of Anesthetist should be available as and when required.
3. Pathology Laboratory Facilities. - 3.1. To supervise the Laboratory work, to interpret and give the result; every Small Laboratory should have at least one registered medical practitioner of modern medicine having minimum qualification of a DCP or equivalent post-graduate diploma or a MBBS degree with at least five years experience in laboratory medicine
3.2To carry-out the laboratory work; every Small Laboratory should also have at least one qualified medical technician/ technologist on duty having minimum qualification of 2 years diploma in Medical Laboratory technology like DMLT or equivalent and at least one Healthcare attendant/assistant.3.3To supervise the Laboratory work, to interpret and give the result, every Medium Laboratory should have (a) all the medical professionals as mentioned under the small laboratory; and (b) at least another qualified person having a minimum qualification of MD (Biochemistry) or equivalent post-graduate degree like MSc (Medical Biochemistry).3.4To carry-out the laboratory work; every Medium Laboratory should also have (a) all the paramedical professionals as mentioned under the small laboratory; and (b) at least another qualified medical technician/ technologist on duty having minimum qualification of 3 years degree in Medical Laboratory technology like BMLT or 2 years post-graduate diploma like PGMLT or equivalent.3.5To supervise the Laboratory work, to interpret and give the result; every large Laboratory should have (a) at least one registered medical practitioner having minimum qualification of a MD (Pathology) or equivalent post-graduate degree; and (b) at least one registered medical practitioner having minimum qualification of a MD (Microbiology) or equivalent post-graduate degree like MSc(Medical Microbiology); (c) at least one registered medical practitioner having minimum qualification of a MD (Biochemistry) or equivalent post-graduate degree like MSc (Medical Biochemistry).3.6To carry-out the laboratory work; every large Laboratory should also have (a) all the paramedical professionals as mentioned under the medium laboratory; and (b) at least another qualified medical technician /technologist on duty having minimum qualification of 2 years post-graduate degree in Medical Laboratory technology like MSc(MLT), MSc (Bio-med Laboratory Science and Management) or equivalent.3.7Multi-disciplinary laboratories should identify a group leader, with specific qualification for each. One medical technician /technologist with adequate qualification/experience shall act as in-charge of quality control of lab work in cases of laboratories having more than one medical technician /technologist.Explanation. A qualified person having Ph.D. in the respective discipline should be considered as equivalent.3.8A collection center should be under supervision of a registered Medical Practitioner of modern medicine. The collection centre should have one on-duty qualified medical technician/technologist or support staff having Higher secondary (with bioscience) certificate with a minimum five year experience in an established medium sized laboratory or certificate in Laboratory-Assistant (Blood transfusion/Phlebotomy) or such relevant courses.4. X-ray Lab. - 4.1. The X-ray lab should have at least one Radiologist or registered medical practitioner of modern medicine having minimum qualification of a DMRD or equivalent post-graduate diploma/degree to supervise the test, to interpret and give the result.
4.2The Radiologist should have at least one helping hand preferably one on-duty qualified paramedic like Radiographer or Medical Technician (X-Ray) in that X-Ray lab and at least one GDA (preferably female) in that X-Ray Lab.5. Ultrasonography Laboratory. - 5.1. Notwithstanding anything contained in the PC-PNDT Act, the Ultrasonography lab/clinic should have at least one Radiologist or a Sonologist to perform the test, to interpret and give the result.
Explanation 2. 'Sonologist' means a registered Medical Practitioner of modern medicine as defined under PC-PNDT Act.5.2The Radiologist/ Sonologist should have at least one helping hand preferably one GDA (preferably female) in that Ultrasonography Laboratory.6. Clinical Physiological test laboratory. - 6.1. In case of laboratories conducting Electro-cardiography, Electro-encephalography; Electromyography or other Clinical Physiological tests, there should be at least one registered medical practitioner of modern medicine having minimum qualification of a post-graduate diploma/degree in physiology or equivalent in the relevant field to supervise/ perform/conduct the test, to interpret and give the result
6.2The Physiologist should have at least one helping hand preferably one on-duty qualified paramedic like Medical Technician (ECG), Medical Technician (EMG) etc. and at least one GDA (preferably female)in that laboratory.7. Other Diagnostic Imaging Laboratory. - 7.1. In case of other Diagnostic Imaging Laboratory, there should be at least one registered medical practitioner of modern medicine having minimum qualification of a post-graduate diploma/degree in concerned discipline to supervise/ perform/conduct the test, to interpret and give the result
7.2The Doctor of such lab should have at least one helping hand preferably one on-duty Medical Technician qualified in concerned discipline and at least one GDA (preferably female).
III
Standards for Equipment, Medical Devices, Medical Supplies[See rule 17]Part I – General 1. Introduction. - 1.1. The clinical establishment should maintain the Equipment, Medical Devices, Medical Supplies standards and norms as specified in this schedule or any such standards and norms as may be notified from time to time.
1.
1.1'Medical device' means any instrument, apparatus, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: (i) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: (a) diagnosis, prevention, monitoring, treatment or alleviation of disease, (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury, (c) investigation, replacement, modification, or support of the anatomy or of a physiological process, (d) supporting or sustaining life, (e) control of conception, (f) disinfection of medical devices, (g) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and (ii) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.1.1.2. 'Medical supplies' means artificial limbs, teeth or eyes, or any prosthesis, orthopedic or surgical appliances or supplies, optical appliances, supplies or equipment, devices for aid of hearing, or any other medical devices, drugs, medication or any other goods, consumables, or supplies prescribed for medical diagnosis, care or treatment.1.2If not mentioned otherwise, the clinical establishment should follow the IPHS regarding equipment and medical supplies for that category of establishment and Guidelines for Good Clinical Laboratory Practices by Indian Council of Medical Research.1.3The clinical establishment should provide adequate numbers of Equipment of good quality depending upon the service offered by that clinical establishment. The clinical establishment should be reasonably satisfied about the quality of the Equipment, Medical Devices, Medical Supplies before procurement of the same. It should procure Equipment, Medical Devices, Medical Supplies with BIS standard as far as possible. While commissioning or decommissioning such equipment, the clinical establishment should follow the manufacturer's guideline.1.4All equipment should be in good working condition at all times to meet workload requirement. Periodic inspection, cleaning, maintenance of equipment should be done as per manufacturer's guideline.1.5New equipment should be checked, calibrated and validated before routine use. Periodic performance check/ calibration check for all equipment should be done using reference standard/reference material.1.6Under no circumstances should the completion of necessary equipment servicing or calibration be delayed or cancelled in order to accommodate further service provision.1.7The list of equipment and medical supplies mentioned in this schedule is only indicative in nature not exhaustive. The Licensing authority shall have the power to add, delete or modify the name or number of required articles mentioned in the list if he is reasonably satisfied.2. Medical Gas. - 2.1. If central medical gas supply system is not available then (a) Oxygen cylinders should be provided as per the following norms: (i) Two standby Oxygen cylinders for each case in the Operating theatre; (ii) Two cylinders/8 beds for Wards; (iii) Two cylinders for each Delivery room; (iv) Two cylinders for Emergency area/ward. Stock for one week should be maintained. In each of these areas flow meter and trolleys should be provided and (b) Suction apparatus should be provided as per the following norms: (i) One suction apparatus for operating theatre; (ii) One suction apparatus for delivery room; (iii) One suction apparatus for every eight beds; (iv) One suction apparatus for emergency and casualty patients. At least two of these should be foot operated.
2.2If central medical gas supply system is available then (a) Oxygen outlet should be provided as per the following norms: (a) Two outlets per table for each Operating theatre; (b) Separate outlet per table/bed for each Delivery room/ Recovery room/ Emergency area/ward; (b) vacuum outlet should be provided as per the following norms : (a) Two outlets per table for each Operating theatre; (b) Separate outlet per table/bed for each Delivery room/ Recovery room/ Emergency area/ward. In these entire areas one O2 cylinder should be kept as spare.2.3Nitrous oxide outlet should be provided as per the following norms: One outlets per table for each Operating theatre.2.4These three pipelines have to be of different colours conforming to a laid down standard and mounted on wall or ceiling surface. Precautions should be taken regarding the storage of oxygen and nitrous oxide.Part II – OPD Facilities 1. Examination /Treatment /Dressing room of OPD and IPD facilities. - 1.1. Each Examination Room should be provided with equipment with such minimum numbers like: (a) Chair for consultants (One for each consulting room); (b) Chairs for patient and persons accompanying patient (Two/three per consulting room and casualty); (c) Revolving stool (metallic - One for each consulting room); (d) Doctor's table (One for each consulting room); (e) Examination table with safe footsteps, mattress and pillow (One for each consulting rooms); (f) Examination table for Obstetrics and Gynaecology clinic (with appropriate light fixture and stool for doctor); (g) X-ray viewing box; (h) Bowls; (i) Wash basin with liquid soap dispenser and towel rail (One in each consulting room and in casualty), (j) Weighing machine; Screens for every examination table etc.
2. Each Examination Room should be provided with instruments and medical supplies for patient examination like (a) torch, (b) tongue depressor, (c) stethoscope, (d) Blood Pressure Apparatus, (e) Thermometer, (f) Kidney trays, (g) Proctoscope, (small medium and large for surgical OPD), (h) Percussion hammer, (i) Tuning fork, (j) Anterior vaginal wall retractor, Cusco's speculum, Sims speculum (For Obstetrics and Gynaecology OPD); (k) Sterilizer; (l) Gloves; (m) Disposable Syringes, (n) Gloves and Masks; (o) Towels, (p) Bed-sheets; (q) Post exposure Prophylactic kit, (r) First Aid equipments, (s) emergency Drugs etc.
1.3Treatment/Dressing room and Injection room should be provided with Equipment and Furniture like: (a) IV stands; (b) Examination table with mattress to carry out dressings (c) Dressing trolley; (d) Ambu bag; (e) Suction apparatus; (f) Oxygen cylinder with flowmeter; (g) One trolley for oxygen cylinder; (h) Laryngoscope with blades; (i) Resuscitation measures (j) Dustbins with lids etc.1.4Treatment/Dressing room and Injection room should be provided with medical supplies like Hydrogen peroxide solution, Cetrimide solution, solvent ether spirit, Povidone iodine solution, Freshly prepared Eusol, Freshly prepared 1% Na Hypochlorite solution, Cheatles forceps, Drums with sterile gauze and bandages, Sterile packets of catgut, ethylon, prolene, silk, etc., autoclaved linen, sticking plaster, 2% Xylocaine without adrenaline, suture cutting scissors, Disposable syringes (5,10.20 cc); needles curved, cutting and round bodied (small and medium sizes) etc.1.5Emergency trolley tray should be provided with: Inj adrenaline; Inj. soda bicarb; Inj aminophylline; chlorpheniramine; Inj calcium gluconate; Inj Frusemide; Inj vesopressor; Inj. Steroid; Inj. 25% glucose I.V. fluids etc.1.6Catheters tray should be provided with: Endotracheal tubes tray (all sizes of cuffed tubes) with connectors; Oropharyngeal airway (all sizes); Spirit bottle; Syringes and needles; Foleys Catheters etc.1.7Venesection tray should be provided with: Small plain forceps and small toothed forceps; Venesection scissors; Curved cutting needles medium sizes; Small mosquito forceps; Towels; suture materials; One bowl; Lubricating jelly etc.Part III – IPD Facilities 1. General. - 1.1. The number and type of such equipments should vary with the services being provided and work load in the Nursing Home, but to provide the optimal services and to maintain the sterility of the equipment/ instruments, each nursing Home should be provided with adequate quantity and quality of equipment and medical supplies like (a) equipment for emergency (b) equipment for ward (c) Trolley and Stretcher; (d) Hospital furniture; (e) Linen etc.
2. Each IPD facility should be provided with such equipments for emergency like suction machine with generator connection and standby foot suction machine; all instruments /equipments required for emergency and Basic life support (CPR); Emergency Tray; ECG Machine; Dressing trolley; Resuscitation tray.
1.3Each IPD facility with OT should have at least one OT table per 30 beds of part thereof.1.4In case of IPD facility having 30 or more beds, it should be provided such equipment and medical supplies like : (a) Desk/counter; (b) Wall clock; (c) Wash basin with liquid soap dispenser and towel rail; (d) Sink unit; (e) Notice boards; (f) Firefighting equipment; (g) Enema can-set (One per ten beds); (h) Vohler-Braun splint (for limb elevation); (i) Ophthalmoscope; (j) Torch (One large size -3 batteries and one small size -pin-point source); (k) Percussion hammer; (l) Laryngoscope with blades of all sizes; (m) Medicine trolley; (n) X-ray viewing box for one X-ray plate; (o) Refrigerator 300 litres; (p) Weighing machine; (q) Speculum and retractors; (r) Height scale (s) Stethoscope; (t) Glucometer; (u) Suture removal sets; (v) Dressing sets; (w) Venesection sets etc.1.5Each IPD facility should be provided with such Trolley and Stretcher for each ward as follows: Minimum of two stretchers/ trolleys and two wheel chairs should be provided. These stretchers/ trolleys/ wheel chairs should always be functional in noiseless condition.1.6Each IPD facility should be provided with Hospital furniture (per bed one of each) like bedside lockers with table top; Chair/Stool; urinal; bed-pan; sputum cup, kidney tray, bedsteads separate IV stands need not be provided); drip stand; One dustbin with lid; Indoor papers stand/holder.1.7Each IPD facility should be provided with Linen adequate scale. Fresh blankets and linen-set should be supplied at the time of admission. Sheet and cover should be changed on daily basis.1.8Each Ward store should be provided such equipment and medical supplies like (a) Storage racks; (b) Oxygen cylinders; (c) IV stands; (d) Suction apparatus; (e) IV fluids and IV sets; (f) Foley's catheters with urine bags; (g) Naso-gastric tubes etc.1.9Each IPD facility having Operation theatre should be provided with OT equipment like: (a) Anaesthesia machine with complete accessories; (b) Multi Channel Monitor; (c) Pulse Oxymeter; (d) Suction apparatus - Electric/ Battery/ Foot operated; (e) Operating Room lights; (f) Bipolar Electro -Surgical Cautery; (g) Resuscitation Trolley; (h) Facilities for Blood Transfusion; (i) Surgical operating instruments for type of surgery which is being conducted in the Nursing Home; (j) High pressure autoclave with modern system of quick sterilization of surgical instruments, operating linen and other items; Defibrillator with automatic external defibrillator and Ventilator etc.1.10Nursing station should be provided with Equipment & Furniture like: (1) Desk/counter; (2) Chairs; (3) Notice boards; (4) internal communicating system; (5) Storage space; cupboards, etc.2. Maternity Home. - 2.1. All Maternity homes should have at least one Labor table and one OT table per 15 beds or of part thereof and one OT table per 30 beds or of part thereof.
2.2All Maternity home should have the following additional instruments and equipment for emergency obstetric care including LUCS at the rate of at least one such per labour table like:, Low mid cavity foreceps/ Kielland foreceps, Vacuum extractor and suction machine; D and C sets; MTP set; Cervical exploration set; Uterine packing forceps; Post partum ligation set; Abdominal and Vaginal Hysterectomy set; Tuboplasty set; Electrocautery diathermy set. Anaesthetic equipments.2.3All Maternity home should have the following additional instruments and equipment for Labour Room and Newborn corner at the rate of at least one such per labour table like: Delivery set; Doppler Foetal monitor; suction machine with generator connection and standby foot suction machine; Neonatal Resuscitation kit; oxygen cylinder; radiant warmer; phototherapy unit weighing machine for the babies.3. CCU / HDU. - 3.1. The beds should have a firm base to permit cardio-pulmonary resuscitation and should be movable easily. Provision should be there to alter height of the head and foot of the patient and the plank at the head end should be detachable to facilitate endotracheal intubation when required.
3.2It should be provided with adequate quantity and quality of equipments and oxygen (preferably central oxygen or one oxygen cylinder per bed with two standby cylinders) etc. An indicative List of Equipment (12 Bedded CCU and 8 Bedded HDU) is given below: (1) Bedside Monitors (at the rate of one per bed of ICU) with Modular -2 Invasive BP, SPO2, NIBP, ECG, RR, Temp Probes with trays; (2) 6-12 Ventilators with paediatric and adult provisions, graphics and Non-Invasive Modes (Two Ventilators should be with inbuilt compressor. Each should have a heated Humidifier;(3)3 Non invasive Ventilators with Provision for CPAP and IPAP; (4) Infusion Pumps (at least 2 per bed in ICU or 1 per Bed in HDU) with Volumetric with all recent upgraded drug calculations; (5) Syringe Pumps (at least 2 per bed in ICU) with recent up gradation; (6) Head End Panel (at the rate 1 per bed) with two O2 Outlets, two vacuum, one compressed air and twelve electric outlets , provision for Alarm, trays for two monitors, Two Drip stands, one Procedure light; (7) Defibrillator (2 with TCP facility - 1 standby) with Adult and paediatric pads with Transcutaneous pacing facility; (8) ICU Beds (Shock Proof) (Fibre) Electronically Maneuvered with all positions possible with mattress; (9) Over Bed Tables (1 for each Bed) with all SS with 6 to 8 cupboards in each to store Drugs, side tray for x-rays, BHT, on wheels; (10) ABG Machine (1 plus 1 standby) with facility for ABG and Electrolytes; (11) Crash/ Resuscitation trolley to hold all resuscitation equipment and Medicines (at the rate of 2 for CCU and 1 for HDU; (12) Pulse Oxymeter (Small Units 2 as stand-by units; (13) Refrigerator (1 per CCU) with freezer compartment; (14) HD Machines (2 per CCU) with user friendly so that even a Nurse can operate; (15) CRRT (1 per ICU) with high flow /Speed Model; (16) CO, SVR, ScvO2 Monitor (1 per CCU); (17) Intermittent Leg Compressing Machine to prevent DVT (2 per CCU); (18) Airbeds to prevent Bed sores (1 per 2 beds); (19) Intubating Video scope to make difficult intubations easy (1 per CCU); (20) Glucometer (2 for ICU, 1 for HDU); (21) ICU Dedicated Ultrasound and Echo machine (1 per CCU) with recent advances to look instantly even at odd hours. Vascular filling, central lines, etc,; (22) Bedside X ray (1 per CCU); (23) ETO sterilization to sterilize ICU disposables regularly (1 per CCU); (24) Spinal Board for spine trauma patients (2 per CCU); (25) Rigid Cervical Spine collars for stabilizing cervical spine (2 per CCU); (26) Ambu Mask different sizes Silicon, ETO sterilisable (10 sets including 2 for Pediatric use); (27) Pollution control buckets (1 set for each Bed); (28) Trays for Procedures For putting central lines, ICD, catheters etc; (29) I A Balloon Pump (1 per CCU); (30) Fibro-optic Bronchoscope (1 per CCU); (31) Computers with LAN, Internet facility and printer to be connected with all departments.Part IV – Pathology Laboratory 1. General. - Should be as per NABL accredited norms
1. Equipment performance should be verified from Internal Quality Control assessment and External Quality Assessment. Outlier parameter trend analysis record should be maintained in respect of its effect on the equipment. The frequency of performance check should be based on the day-to-day performance of the equipment
1.2In case of large laboratory, all analytical equipment should be calibrated and calibration certificate provided by authorized agency. Non-analytical equipment such as pipette, thermometer, weighing balance and centrifuge should be calibrated by accredited calibration laboratory or done in-house with traceability to National Physical Laboratory (NPL).1.3The pathology laboratory should be provided with the Furniture & Fixtures as per following norms: (a) 600mm wide and 900mm high bench/table/counter/cabinet of length about 2 meters per technician and to full width of the room for pathologist in charge of the laboratory. Top of the laboratory bench should be of acid alkali proof. (b) laboratory sink with swan neck fittings, reagent shelving, gas and power point under counter cabinet.1.4Standard reagents of certified quality should be used for the purpose of analysis. The batch number of reagents should be recorded. The quality of the reagent viz. Analar grade, HPLC grade, etc. as per standards of the manufacturer of the machine to be used for in-house procedures should be defined in SOP. Those reagents are to be recorded in stock register.1.5Quality of newly purchased reagents should be validated against suitable control/reference material prior to use. Validation data should be properly documented. In-house prepared reagents should also be checked periodically for stability and a record of the same should be maintained.1.6Reagent label should contain name of reagent, concentration, date of preparation/opening, date of expiry, storage conditions and warnings e.g. 'do not use if solution is turbid' where applicable. When individual bottles are small, this information can be recorded in a goods received ledger.1.7Microbiology laboratories should check activity/potency of each lot of antibiotic sensitivity discs before using and at least weekly thereafter with reference strains. Other microbiological consumables such as strips etc. used for identification should be checked against reference strains. Laboratories testing microbiology specimens should check the quality of media by using appropriate reference strain and pH of the media.1.8All batches of culture containers should be checked for sterility before issuing to patients for collection of specimen.1.9Water quality should be checked for its grade and presence of interference elements. Reagent grade water according to IS1070 : 1992 of Bureau of Indian Standards (BIS) should be used for testing.2. Specific. - 2.1. Depending upon the services available, the small, medium or large laboratory should be provided with (a) General equipments for lab; (b) Equipments for Clinical Pathology; (c) Equipments for Histopathology; (d) Equipments for Microbiology; (e) Equipments for Haematology; (f) Equipments for Biochemistry; (g) Equipments for Serology.
2.2General equipment for lab: Autoclave; Infection control coded bags and buckets; Equipment for collection and thereby transport of various specimens from outside the lab; Other miscellaneous necessary equipment depending upon the function of the lab, needle destroyer stopwatch, slide trays, test tube stands, stop watch etc.2.3Equipment for Clinical Pathology: Binocular Microscopes; Auto-analyzer/multi-functional for hematology and biochemistry; Coagulometer; Colorimeter; Centrifuge; Water bath; Refrigerator; ESR tubes; Counting chambers; Micro pipettes; Preservative vials preferably vacutainers; Glass slides; Disposal methods for collections of specimen.2.4Equipment for Histopathology: Automatic tissue processor or standard methods of hand processing; Hot air oven; Hot Plate; Microtome (rotatory); Automatic knife sharpener or standard method; Water bath with thermostat; Glass specimen containers (small and large); Tissue cassettes with lids (steel made); L molds (large and small); Spirit lamps; Wax (paraffin with ceresin) melting point 58 -600 c.; Slides and cover slips; Diamond pencils; Surgical grossing instruments e,g knife, scissors, foreceps, blades etc; weighing machine (electronic preferred); Disposables gloves, masks and white coats; Kits for immunohistochemistry and other necessary equipment; Stains and other reagents.2.5Equipment for Microbiology: Various media for culture and sensitivity; Swab sticks, transport media, universal containers, blood culture bottles; Antibiotics disks; Biological safety cabinet II; Discard jars and disinfectants; Loops, wires, spirit lamps etc.2.6Equipment for Haematology: Microscope; Cell Chamber; Cell Counter, Haemocytometer; Centrifuge etc.2.7Equipment for Biochemistry: Centrifuge; Colorimeter/Semi-autoanalyzer; Refrigerator; Micropipettes; Water bath etc.2.8Equipments for Serology: Centrifuge; Refrigerator; Water bath; Incubator etc.2.9For the disposal of Lab material every Lab should have needle destroying unit, sodiumhypochlorite solution, lab wash and formalin solution for fumigation of the Lab and other appropriate provisions as per Environmental Protection Act.Part V – Diagnostic Imaging Laboratories 1. X-Ray laboratory. - 1.1. X-ray equipment for medical diagnostic purposes need to be purchased from approved vendor. There should be installation of "Type approved" X-ray equipment for medical diagnostic (Certificate of "Type Approval" to be obtained from AERB). Any radiation equipment/radiation installation should be commissioned only after all aspects including design, planning construction and operation have been duly approved by the AERB.
2. X ray machines should be of 100-1000 MA (as per scope of services), dental X-ray of 6MA and OPG X-ray of 4.5 to 10 MA. Each X-ray laboratory should be provided with the following protective accessories: Protection Screen; Lead apron 1-1.5 mm thickness upto 75 kV; Protective gloves; Protective goggles; Lead blocker for protection of generative organ or patients; Cones; film-badge etc. and other such as per AERB guideline.
1.3The laboratory should be provided with: (1) Cassettes with intensifying screens; (2) Chair, (3) Dark room with safe light; (4) Dark room timer; (5) Film clips; (6) Film hanger and wall brackets; (8) Hanger for X-ray film; (9) Lead numbers for marking X-ray film; (10) Magnifying glass; (11) Step stools; (12) Revolving stool; (13) Tank thermometer; (14) Patients' trolley; (15) Wash basins with towel rail/liquid soap dispensers; (16) X-ray view box; (17) X-ray protection screen; (18) X-ray film processing tank; (19) X-ray film corner etc.1.4X-ray equipment's and protective clothing's should be checked from time to time. For this purpose, fluorescent screen should be used. Safe light provision and Developer tanks/tray is a must for Dark room. There should be appropriate resuscitation equipment and drugs available on site for management of contrast reactions.1.5All the equipments should be checked and calibrated for at least the following: (a) Calibration of signal to noise ratio (wherever applicable); (b) Calibration of mA; (c) Calibration of kV; (d) Calibration of timer; (e) Check geometric distortion; (f) Check of Phantom image quality; (g) Check of functioning of film processing units etc.1.6In addition all the equipment should be checked and calibrated specifically for the following: (a) All X-ray machines should be calibrated as per AERB guidelines; (b) Calibration of mA; (c) Calibration of Kv; (d) Calibration of timer; (e) Check of collimeter/diaphragm/lead curtains; (f) Check of table movement and tilt; (g) Check phantom image quality; (h) Check of positioning accuracy; (i) Check of film processing unit etc.1.7Notwithstanding anything mentioned above, X-Ray lab with digital X-ray facilities, appropriate equipment should be provided.2. Mamography Laboratory. - 2.1. There should be dedicated mammographic equipment with a grid and appropriate compression device. Mammographic biopsy attachment is desirable. (Certificate of "Type Approval" to be obtained from AERB).
2.2In addition all the equipment should be checked and calibrated specifically for the following: (a) Collimation alignment check; (b) Focal spot size measurement; (c) Beam quality half layer value HLV assessment; (d) Automatic Exposure Control (AEC) check; (e) Artifact evaluation; (f) Breast compression deice check; (g) Screen cleanliness check.3. Ultrasongraphy. - 3.1. The equipment should be registered under the Pre-conception and Prenatal-diagnostic Techniques Act and rules and the certificate should be displayed along with mandatory display. Registration of clinic is mandatory along with details of machine and radiologist/sonologist. The equipment should have convex, sector and linear probe with frequencies ranging from 3.5 MHz to 12MHz. Equipment for vascular studies should have colour Doppler imaging capability. There should be a trans-vaginal probe where pelvic imaging and obstetric imaging is offered and other endo-cavitory probes as per scope of services. Each USG Clinics should be provided with USG scanner, printer, CTV, table and couch for patient.
3.2In addition all the equipment should be checked and calibrated specifically for the following: (a) Calibration of calipers; (b) Calibration of power output.4. Bone mineral densitometry. - 4.1. There should be a phantom/other calibration standards to evaluate the accuracy of Bone mineral density measurement. There should be software to compare with standards (specific to the equipment) which are age and gender related normal.
4.2In addition all the equipment should be checked and calibrated specifically for the following: (a) Maintenance of QCT software, phantom and associated accessories; (b) Recalculation of LSC (least significant changes) in case of replacement of a CT scanner, CT X-ray tube, recalibration of CT scanner or modification to the QCT accessory components.5. MRI. - 5.1. MRI equipment should meet the requirements for safety in medical diagnosis. MRI equipment should also meet safety requirements for machinery, electronic and medical devices associated with the unit. An automatic film processing unit should be linked to the MRI for documentation purposes.
5.2In addition all the equipment should be checked and calibrated specifically for the following: (a) Calibration centre of frequency; (b) Check of shimming; (c) Check of gradient linearity; (d) Check of spikes; (e) Check of auditory noise level; (f) Check of ghost intensity; (g) Quench pipe of MR should be safely positioned; (h) Equipment in the unit should be MR compatible including trolleys; (i) Certificate of fitness for use my manufacturer for units more than 10yrs old.5.3The equipment should be registered under the PC-PNDT act as per rules and the certificate should be displayed along with mandatory display.6. CT scan. - 6.1. Whole body CT-Scan with scan cycle less than I sec (sub second). Installation of all equipments should be approved by AERB. Basic life support and resuscitation equipment and drugs should be available on site.
6.2The tube housing, Beam limiting devices, Beam filtration, scan plane accuracy couch position accuracy, Beam-ON indicators, scan increment accuracy, gantry aperture clearance, Image receptors, visual indicators, timer and warming conditions should be as per AERB Safety Code No. AERB/MED -20(Rev.1).6.3In addition all the equipment should be checked and calibrated specifically for the following: (a) Calibration of signal to noise ratio; (b) Calibration of mA; (c) Calibration of Kv; (d) Check of phantom image quality; (e) Check for radiation leakage wherever lead glass is installed; (f) Calculation of dose for each case and a log/ record of the same should be maintained; (g) Certificate of fitness for use by the manufacturer for machines more than 10yrs old.7. Interventional radiology. - 7.1. There should be fixed high resolution image intensification system with a minimum field of 25cms. Sites performing angiography should have digital acquisition and subtraction facilities. The angiographic injector should be capable of injecting varying rates and volumes and it should have appropriate safety mechanism to prevent over-injection.
7.2Mobile intensifiers are not recommended for diagnostic angiography on a routine basis due to their limitation and image quality and data handling and also increased requirement of contrast and increased radiation dose and produces suboptimal images of thick body parts.7.3There should be facilities for patient monitoring by ECG/BP monitoring/pulse oximetry / monitoring of direct pressure gradients as required by the scope of services listed.7.4The supply of diagnostic and therapeutic devices should be sufficient to support the range of services offered and for treatment of possible complications arising therein (e.g. transcutaneous ultrasound, intra arterial ultrasound, thrombectomy and arthrectomy devices, with associated catheters, tissue ablation devices).
IV
Standards for Water, Sanitation, Hygiene, Safety & Security[See rule 21]Part I – . Introduction 1. General. - 1.1. The clinical establishment should maintain the Water, Sanitation, Hygiene Safety and Security standards and norms as specified in this schedule or any such standards and norms as may be notified from time to time.
2. Service-provider should be thoroughly trained in managing fire, and non-fire emergencies such as large spillage, gas leakage etc.
1.3Periodic checking of all safety equipment and accessories should be ensured.1.4Accident/incident/injuries record of service-provider and service-recipient, and public should be maintained and reported to the designated authority. The report should include description of the event, factors contributing to the event and information on first aid or other health care provided. This information can be analyzed periodically towards effectively controlling and preventing future events. The records should be checked periodically by the Doctor incharge even in the absence of fresh entries.1.5Following sentinel events should be recorded, registered and reported to the authorities: (a) deaths of patients of the clinical establishment from unexplained cause or under suspicious circumstances, assault, or abduction of any patient, attempt of suicide by any patient; events of missing presumed to be absconding patient that are required to be reported to police; (b) fires in the clinical establishment resulting in death or personal injury or damage to the property; or (c) any act of violence or damage to the property as specified in the West Bengal Medical service persons and Medicare Service Institution (Prevention of Violence and Damage to Property Act, 2009 [West Bengal Act XI of 2009]; or (d) malfunction or intentional or accidental misuse of patient care equipment that occurs during treatment or diagnosis of a patient of the clinical establishment and that did, or if not averted would, have significant adverse effect on the patient or staff of the clinical establishment; or (e) confirmed or suspected outbreak of any disease; or (f) any form of closure of suspension of work; (g) any other sentinel events as may be notified.2. Location and surroundings. - 2.1. The clinical establishment should be situated in a site having clean and hygienic surroundings free from nuisance and should not be adjacent to an open sewer drain, filth, garbage bins or public lavatory or to a factory emitting smoke or obnoxious odor or public conveniences and any surrounding in unsanitary condition.
Explanation. - 1. The term "Unsanitary condition" means a condition or circumstance: (a) that is, or may be, or might become injurious to health; or (b) that prevents or hinders the suppression of disease; or (c) that contaminates or pollutes, or may contaminate or pollute food, air, or water; or (d) that might render food, air, or water injurious to the health of any person; and includes a nuisance and any circumstance or condition declared to be an unsanitary condition by notification.Explanation. - 2. The term "Filth" means: (a) night soil and other contents of latrines cesspools and drain; or (b) dung and the refuse of useless or offensive material thrown out in consequence of any process of manufacture, industry or trade; or (c) putrid and putrefying substances and (d) all other substances causing danger to the public health.Explanation 3. The term "Nuisance" includes any act, omission, place or thing which causes or is likely to cause injury, danger, annoyance or harassment offence to the sense of sight, smell or hearing or disturbance to rest or sleep or which is or may be dangerous to life or injurious to the health or property of the public or the people in general who dwell or occupy property in the vicinity or person or persons who may have occasion to use any public right.2.2The clinical establishment should not be located in a dingy, damp or otherwise unsuitable building and premises in unsanitary condition. The site should be compatible with other considerations such as accessibility and availability of services and should be approved by the appropriate authority.2.3The surrounding should be quite. The Government should declare the surroundings of the clinical establishment as a 'noise-free zone' and should impose restriction in exercise of power as per Environmental Protection Act and other relevant Acts and rules.2.4No clinical establishment shall be allowed to function from an unsafe building.Explanation. - Unsafe Building is a building which (a) is structurally unsafe, (b) is not sanitary; (c) is not provided with adequate means of egress; (d) constitutes a fire hazard; (e) is dangerous to human life; and (f) in relation to its existing use constitutes a hazard to safety or health or public welfare by reasons of inadequate maintenance, dilapidation or abandonment.2.5The clinical establishment shall not conduct in any way which may lead to environmental problems including unsanitary condition, filth or nuisance.3. Health, Clothing and Sanitary Requirements of staff. - The staff should be free from contagious disease and should be provided with clean uniforms suitable to the nature of their duties. The staff should be medically examined at the time of employment and periodically so examined thereafter. The clinical establishment should generate and maintain proper records thereof.
4. Sanitation and Hygiene. - The clinical establishment should apply the "Precautionary Principle" wherever and whenever necessary. The interior should be clean and hygienic. All the rooms/ wards should be properly ventilated and have adequate lighting facilities. Arrangement should be made for sanitary fitments as mentioned in this schedule. There should be adequate Sewage Disposal arrangement.
5. General Water Supply. - 5.1. Arrangement should be made to supply adequate quantity and quality of water. The inpatient facilities with 30 or more beds should have supply of at least 350 litres of potable, wholesome water per day, per bed to meet all requirements (including laundry), except fire fighting.
5.2The term "Wholesome water" means water that is: (a) free from pathogenic agents; and (b) free from harmful chemical substances; and (c) pleasant to the taste, i.e. free from colour and odour and (d) usable for domestic purposes.5.3Storage capacity for minimum 48 hours requirement should be made on the basis of above consumption. Systems should be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand. Arrangement should be provided to ensure uninterrupted water supply for operation theatre.5.4In case of inpatient facilities with 30 or more beds, hot water supply to wards and departments of the general hospital should be provided by means of electric storage type water heaters or centralized hot water system of capacity depending upon the need of hot water consumption.6. Signage. - The clinical establishment should have properly displayed safety signs, for example: (a) signs of identification of safety equipments such as fire extinguishers, showers, eyewash facilities, (b) signs to identify hazards and hazardous activities, (c) public utilities like toilet, water fountain etc, (d) signs to delineate public areas from area of restricted access etc;
7. Standard Fire safety measures. - 7.1. It should be provided as per West Bengal Fire safety Act/Rules and Guidelines issued by that department.
7.2Adequate fire/ smoke detection equipment; extinguishers etc. should be readily available in the premises.8. Standard Biosafety Measures. - 8.1. Entry into Laboratory/work area should be restricted. Staff should be attired with aprons or suitable clothing for working in the laboratory. Work surfaces should be disinfected when procedures are completed and at the end of each working day.
8.2Gloves should be worn for handling of infectious material. Examination gloves of vinyl or latex should be used in laboratory, ward, operation theatre. General purpose utility gloves (i.e. rubber gloves or household gloves, reusable) should be used while cleaning instruments, decontamination procedures and other activities where manual dexterity is not required.8.3In operation theatres and delivery rooms, cleaning should be carried out every day. Cleaning with suitable disinfectant has to be carried out and swabs should be sent to laboratory for cultures regularly. Fumigation should be done as and when necessary. Records for the same should be maintained so that they can be scrutinized periodically. All horizontal surfaces including floor should be mopped between cases.8.4All medical instruments should be properly sterilized. Hepatitis vaccine should be provided for all personnel. Adequate arrangements for pest and rodent control should be provided by the clinical establishment.8.5The clinical establishment shall comply with all the provisions of Bio-Medical waste management handling rules as applicable for that type of establishment.9. Safety measures against Disaster. - It should be provided as per IPHS guideline.
Explanation. "Disaster" and "Disaster Management" shall have the meaning as defined under The Disaster Management Act, 2005 [Act 53 of 2005].10. Personal Security. - 10.1. Before engaging or empanelling anyone under rule 8 as service provider particularly who will have direct access or provide direct services to a patient, the clinical establishment shall require that person to submit to a background search particularly related to criminal history and patient abuse background search.
Explanation. 'Direct access' means physical access to a patient or resident and "direct services" means services provided to a patient or resident, which access or service gives the provider an opportunity to commit abuse or neglect or misappropriate the patient's property.10.2In case of hospital, adequate number of private security guard, preferably under the contract with a private security agency having license under Private Security Agencies (Regulation) Act, 2005 [Act 29 of 2005], should be provided.Part II – . Specific 1. Radiation safety. - Rooms housing diagnostic X-ray units and related equipment should be located preferably on ground floor as far away as feasible from areas of high occupancy and general traffic, such as maternity and paediatric wards and other departments of the hospital. The machine should be placed at the end of the lab so as to have less lead shielding of the walls. The X-ray lab should take due safeguards against the radiation protection and should adhere to prescribed regulations of AERB as amended from time to time.
2. Water supply. - Filtered and soft water supply should be arranged in pathology laboratories. Cold water supply should be arranged for processing tanks in film developing room, Water for Dialysis unit should be de-ionized using reverse osmosis process and disinfected by ultraviolet radiation.
3. Sanitary Fitments. - 3.1. The pathology lab should maintain a separate toilet. The radiology lab should have separate toilet facilities in case it carries out procedures like IVP, Barium X-ray, etc.
3.2Sanitary Fitments for IPD and OPD should be: (a) Water closets for males at the rate of 1 for every 40 persons or 8 beds or part thereof; (b) Water closets for females at the rate of 1 for every 25 persons or 6 beds or part thereof; (c) Ablution taps for males at the rate of 1 for each water closet plus one water tap with draining arrangement in the vicinity of water closets; (d) Ablution taps for females at the rate of 1 for each water closet plus one water tap with draining arrangement in the vicinity of water closets (e) Urinals (males only) at the rate of 1 for every 25 persons or 12 beds or part thereof; (f) Wash basins and drinking water fountains for males at the rate of 1 for every 50 persons or 12 beds or part thereof; (g) Wash basins and drinking water fountains for females at the rate of 1 for every 50 persons or 12 beds or part thereof.3.3Sanitary Fitments for IPD only should be: (a) Baths at the rate of 1 bath with shower for every 12 beds or part thereof; (b) Bed pan washing sinks at the rate of 1 for each ward In dirty utility and sluice room; (c) Cleaner's sinks and sink/slab for cleaning mackintosh at the rate of 1 for each ward; (d) Kitchen sinks and dishwashers at the rate of 1 for each pantry forward or cubicles.4. Biosafety Measures in clinical lab. - 4.1. The lab should ensure Safety in laboratories therefore includes protection of both the staff and patient and the environment from hazardous materials in order to minimize (a) the risk of persons from various chemicals, infectious materials, fire hazard, gas leak etc. and (b) the risk of environment being contaminated by hazardous materials used and wastes generated in the laboratory.
4.2Regarding biosafety, the labs should follow the Four levels of biosafety laboratories (BSL) developed by World Health Organization (WHO).4.3All laboratory personnel should be aware about the laboratory safety policies and procedures and follow these at all times. List of hazardous materials used in the laboratory should be prepared. All hazardous materials should be accounted for on a continuous basis. Laboratory personnel should follow safe hygienic practices which include hand washing, wearing protective clothing, gloves, eye protection devices etc. Eye wash facility should be available as "stand-alone" facility or attached to sink. Portable, sealed, refillable bottles should also be available.4.4Biohazard symbol should be used on all such container/equipment containing biohazardous material. Laboratories should ensure proper preservation and security of specimens. Destruction/disposal of hazardous material should be authorized, supervised and handled according to standard procedures.
V
Standard for Operating Procedures[See rule [8, 9, and 10]Part I – Introduction 1. General. - 1.1. The clinical establishment should maintain the Operating Procedure standards as specified in this schedule or any such standards as may be notified from time to time.
2. If the clinical establishment comes across any such medico-legal cases as may be notified, it should report promptly such cases to the police station, within the jurisdiction of which such clinical establishment is located though a Police intimation register maintained and generated by the clinical establishment in such a manner and should contain such particulars as may be notified.
Explanation. 'medico-legal case' means any medical case which has legal implications either of a civil or criminal nature, and includes but is not limited to cases relating to accidents, assault, sexual assault, suicide, attempt to murder, poisoning, injuries on account of domestic violence, injuries on workers during course of employment.1.3The clinical establishment shall follow the standard procedure regarding display of information as mentioned in rule 22.Explanation. - "display of information" means any form of display and includes any advertisement (a) printed in any medium for the communication of information; (b) appearing in, communicated through or retrievable from, any mass medium, electronic or otherwise; or (c) contained in any medium for communication produced or for use by an institution.1.4The licensing authority shall not allow the clinical establishments to be registered with any improper or undesirable name including the words and abbreviation thereof if (a) such name is identical with the name of any society/corporation or local body which has been set up by the Central or State Government under any law for the time being in force; or (b) such name gives the impression of the patronage of Central Government or State Government; or (c) such name is too nearly resembling a name of body corporation or local authority set up by Government under any law for the time being in force; or (d) such name is connoting Government's participation or patronage unless circumstances justify it; or (e) such name is resembling the name of a healthcare establishment run by the Public sector agencies; or (f) such name is not conforming to the clinical establishment's function and the facilities available and services offered thereof; or (g) such name is containing any statement which states, suggests, or implies a false or misleading claim in any particular concerning the services offered thereof (h) such name is not offensive to any section of people, e.g., proposed name does not contain profanity or words or phrases that are generally considered a slur against an ethnic group, religion, gender or heredity.1.5The clinical establishment shall ensure that the name of the clinical establishment or part thereof is not confusing, misleading or undesirable for anyone using that clinical establishment.1.6for effective implementation of quality assurance programme under sub-rule (10) of rule 8, shall, inter-alia, refer to: (a) the composition of the committee including the authority, which will be in-charge of such; (b) the requisite qualification and terms of office for the committee members including experts; (c) the power and function of the committee; (d) the periodicity and manner of such assessment and other standard operation procedures to be followed by the Committee; (e) the manner in which the clinical establishment will be participating in that scheme; (f) the financial implications including recovery of expenses of such committee; (g) any such other details which may result in an of such scheme of reimbursement of expenses incurred.1.7The programme mentioned above and subsequent changes, if any, made thereto from time to time, shall be notified.1.8The one-word descriptions mentioned under sub-rule (10) of rule (9) are not medical terms, and they are more art than science. They're based on a doctor's best judgment of a patient's condition, as relayed to hospital spokespersons.Explanation 1. The term 'Undetermined' means a condition when the Patient is awaiting physician and assessment.Explanation 2. The term 'Good' means a condition when the 'Vital signs' are stable and within normal limits; the patient is conscious and comfortable; and Indicators are excellent.Explanation 3. The term 'Fair' means a condition when the 'Vital signs' are stable and within normal limits; Patient is conscious, but may be uncomfortable; and/or Indicators are favorable.Explanation 4. The term 'Serious' means a condition when the 'Vital signs' may be unstable and not within normal limits; Patient is acutely ill; and/or Indicators are questionable.Explanation 5. The term 'Critical' means a condition when the 'Vital signs' are unstable and not within normal limits; Patient may be unconscious and/or the Indicators are unfavorable.Explanation 6. The term "vital signs" means indicators such as blood pressure, pulse, temperature, and respiration.1.9Regarding obtaining consent mentioned under sub-rule (5) of rule 10, if such third party refuses to give consent to a healthcare intervention necessary to save the life or limb of a patient incapable or giving consent, the appropriate Court of law, upon the petition of the service-provider or any person interested in the welfare of the patient, in a summary proceeding, may issue an order giving consent.10.
Regarding mentioned under sub-rule (6) of rule 10, whenever possible, the clinical establishment shall either engage a professional counselor or orient the staff regarding the scientific techniques of counseling to obtain informed consent.1.11Service of such counselor may be utilized in different situation which includes but not limited to obtaining informed consent related to (i) HIV related procedures and testing, (ii) transfer or referral of patient; (iii) treatment compliance of patient; (iv) Family planning measures; (iv) organ transplant; (v) care and treatment of terminal illness etc.Part II – OPD and IPD Facilities
1. Proper arrangements for attending the patients and prompt answering to their calls should be made available round the clock. All emergency diagnostic procedures should be done immediately. Adequate and wholesome diet should be provided to the patients as per advice of the attending Doctor and Dietician and hygiene with cleanliness is to be maintained in preparation of diet and it's service to the patients. The diet should be prepared and served in hygienic conditions.
1.2All the Operating Procedure standards as mentioned in Chapter II should be maintained.Part III – Pathology Laboratory Facilities 1. Collection. - 1.1. Appropriate counseling should be done before specimen collection and consent taken whenever needed. Attention should be paid to patient's sensibilities during the entire process. Any error in specimen collection should be avoided as it can lead to erroneous results. Stand-alone collection center should not conduct any invasive procedure to collect any specimen except phlebotomy.
2. All pathology Laboratories including Collection centers should have a "primary specimen collection manual", containing information on (a) patient preparation before specimen collection (if any); (b) exact methodology of specimen collection; and (c) labeling, handling, transportation and storage of the specimens. In addition, the laboratory should provide adequate and appropriate information/instructions to patients wherever necessary. The manual should include guidelines on specimen collection including preservation for histopathological examination. These manuals should be available for reference and should be used for training of staff engaged in specimen collection.
1.3Specimen should be secured properly so that there is no leakage, spillage or contamination. A Biohazard symbol should be used on the containers during transportation. Appropriate specimen transportation kit (such as use of dry ice, etc.) should be used wherever required. Specimen should be sent to the reference laboratory along with the proper requisition form.2. Analytical work or Test. - 2.1. The laboratory should maintain an accession list which is a record of all the specimens received by the laboratory for analysis and is prepared by the laboratory at the time of specimen receipt.
2.2It records the patient's identity including name, age, sex, location in the hospital/ medical facility, name of referring physician, lab investigations requested, date and time of receipt of specimen and condition of the specimen at receipt. The laboratory assigns a unique laboratory number to register each specimen received, which can be used to trace the specimen in the laboratory. The test results and remarks if any are also entered in the accession list.2.3The laboratory should maintain a worksheet which is essentially a form provided to the analyst along with the specimen. The following details should be recorded on the worksheet: (a) Date of analysis; (b) Condition of the specimen before starting analysis; (c) Findings and result; (d) Name and signature of the analyst.2.4Laboratory number assigned to the specimen should be mentioned in the worksheet before sending the specimen to the analyst.2.5The specimen should be analyzed according to the plan mentioned in the Standard Operating Procedure (SOP). Any deviations from the analysis plan should be mentioned giving reasons. Wherever applicable the laboratories should use requisition form cum worksheet instead of two separate forms.3. Reporting Test Results. - Test results approved, signed and dated by the authorized signatory should be made available in a sealed cover to authorized person(s) like Patient/Patient party/Medical attendant only. The proper maintenance of the record of the tests undertaken should be maintained in serial number w.e.f 1st January to 31st December every year. All pathological laboratories should provide for a mechanism of 'Critical values reporting' and maintain the Standard Operating Procedure (SOP) thereof. The Government may publish ranges of such critical values by notification.
Explanation. 'Critical values (or panic values) reporting' is the mechanism by which potentially life-threatening laboratory results are reported to responsible healthcare professionals without any delay.4. Quality Control. - Medium/large labs should adopt the external and internal quality control measures to have accuracy and precision. At least two samples per month should be sent to the other registered accredited labs and the results should be compared and recorded properly in the Quality Control Register, which should be produced on demand for inspection.
Part IV – Diagnostic Imaging Laboratory Facilities
1. Sitting room for the patients and attendants should be away from X-ray room and at the time of X-raying patients, no patient party should be normally allowed inside the X-ray room. In case of children being X-rayed, the attendants should, however, be allowed to stay.
1.2In clinics where Radiographic contrast is administered, adequate resuscitation drugs should be available. The safe guard of the patients and staff members against the radiation problems should be ensured as per the guidelines of AERB.1.3The X-ray machines should be operated only by qualified X-ray Technicians. The technicians should wear lead aprons while giving exposures. The Milliamp Seconds (mAs) exposures given by the X-ray technician should be displayed so that the higher radiation does is not given to the patient. Monitoring (Film badge/TLD badge service) should be used.1.4Intensifying screens and X-ray cassettes should be changed after two years or earlier in case they are not giving proper results and the Radiologist should certify it. All records relating to X-ray should be properly maintained. Complete record of the X-ray done along with duplicate report duly signed by the radiologist should be mandatory.1.5Pregnant women should be exposed to radiation only after due consideration by the radiologist of the relative risks and benefits of such exposure and informed consent of the mother. A warning that "X-ray's are potentially harmful and should be done only when advised by the attending doctor" should be displayed in English and local language with warning that "pregnant ladies and small children and infants should not stand near the X-ray machine as a spectator/ patient party with the patient when he/she is X-rayed".
VI
Standards for Records, Reports & Registers[See rule 18 & 22]Part I – . Introduction 1. General. - 1.1. The clinical establishment should maintain the standards and norms related to Records, Reports and Registers as specified in this schedule or any such standards and norms as may be notified from time to time. The state government may publish standard model formats for such registers by notification from time to time.
2. All clinical establishments shall generate and maintain following mandatory registers and records - (a) a staff register under rule 6; (b) a staff attendance register under rule 6; (c) stock-book under rule 17; (d) Dead stock register under rule 17; (e) logbook of major equipment under rule 17; (f) books of account and cashbook under rule 19; (g) Service/OPD register under rule 11; (h) bio-medical waste disposal register under rule 21; (i) Police intimation register under rule 23; (j) Inspection book (register) under rule 37; (k) grievance redressal register under rule 28; and (l) any other records or registers as may be notified.
1.3All clinical establishments with in-patient facilities including day-care centres shall generate and maintain following additional mandatory registers and records - (a) a record of case-sheet of every patient as per rule 11; (b) an admission/ In-patient register for in-patient as per rule 12; (c) Birth register [Log book] under rule 12, if applicable; (d) OT logbook (register) under rule 13, if applicable; (e) register(s) related to procedure under Acts like Pre-conception and Pre-natal Diagnostic Techniques Act under rule 13, if applicable; (f) Referral register under rule 16; (g) Death Register under rule 12; (h) records related to free treatment & concession under rule 20, if applicable; and (i) any other records or registers as may be notified.1.4The clinical establishment shall generate, maintain and submit following mandatory reports - (a) Performance report under rule 11; (b) report related to procedures like MTP under rule 13; (c) Annual reports of free treatment and concession, if any, under rule 20; (d) reports of sentinel events, if any, under rule 23; (e) reports of National/state health programmes under rule 26; (f) reports of notifiable diseases, if any, under rule 26; (g) reports of extract of grievance redressal register under rule 28; and (h) any other reports as may be notified.2. Maintenance. - 2.1. For maintaining various ledgers / registers, the guidelines and protocol as may be notified should be followed strictly. Medico legal documents should be prepared and maintained then and there properly and promptly and be kept safely and separately. Care should be taken to leave none of them incomplete. Statutory Format should be used for preparing those and be identified by marking "MLC" at the right hand top corner of the cover page or identified by any colour code.
2.2A 'Record keeping Register' should be maintained in all section / wards of the clinical establishment with the following minimum title columns: (a) Sl No., (b) Date, (c) Nature of record / register, (d) Date of originating/ receiving the document in the section, (e) From whom received, (f) Condition of the document at the time of receiving, (g) Date of issue / disposal, (h) To whom issued, (i) Order for disposal and (10) Remarks.2.3Responsibility of maintaining / safeguarding the document should be vested with the in-charge of the section but all the staff in the section should have the responsibility of safeguarding every document in that section and with all the staff involved in preparing the registers at various periods till the register is handed over to the Medical Record Department on completion. The overall responsibilities of record keeping should lie with the licensee.3. Preservation and Disposal. - 3.1. All records should ordinarily be preserved in a suitable manner for a minimum period as per the prevalent orders and notifications.
3.2On completion of the register it should be kept under lock and key in the section and/or handed over to the concerned officers to be kept in the Medical Record Section. Other documents are to be kept at the place of origin and disposed after the preservation period.3.3When preservation period of a document is over, it should be treated as inactive and should be disposed in a proper manner/method. The custodian of that document should report the fact to the head of the institution. With permission of the head of the institution those documents should be removed from the Record keeping Register. Head of the institution should issue a proceedings to this effect and copy served to all sections and concerned officials. The procedures of disposal and destruction should be transparent and the file regarding this should be kept safely as this could be produced before the licensing authority on his demand.Part II – Statutory Forms {|
|-| Statutory CE FormI: Application for Registration[See rule 34]|-| Part ACommon for allestablishments including Single Doctor Establishments.[willbe applicable to a Medical Clinic used for or intended to be usedfor consultation and treatment by a registered medicalpractitioner but shall not include any place utilized by aregistered medical practitioner solely for the purpose ofconsultation and advice]01. Application
Acknowledgement: (For office use only)01B. Acknowledgement Date
|-| 02. Purpose ofApplication:02A. Applied for: New
License, 02B. Renewal, 02C. Change or modification ofparticulars, 02D. Composite License, 02E. Issuance of DuplicateCopy, 02F. Submission of additional license fee,02F. Accompanied separate sheet mentioning other
purposes enclosed as enclosure|-| 03. Name of theClinical Establishment:03B. Existing Name:
|-| 04. ExistingClinical Establishment License (if any):04A. Not applicable,
Applicable04B. If applicable,
License:03C. Copy/ copies of
existing license enclosed as enclosure03D. Particulars for any additional license is
enclosed as separate sheet in enclosure|-| 05. Address of theClinical Establishment:05G. Nearest Landmark:
|-| 06. Local Body:06A. Name of the
local body:
Nature of localbody: Corporation, Municipality, Notified area; Panchayat Area06C. The copy of
Property Tax [from local body] enclosed as enclosure No.06D. Location:
Metropolitan, or Urban, or Rural06E. Located at vulnerable area: Yes, No
|-| 07. Name of theApplicant:
Son/Daughter/wife of:07E1. Title4. Last
|-| 08. Address of theApplicant:08G. Nearest Landmark:
|-| 09. System ofMedicine Offered:(Multiple options possible)Allopathy, Ayurveda, Unani, Siddha, Homeopathy, Naturopathy, Yoga,Any other(Pleasespecify __________________________________________________ )10. Subsystem of
Medicine Offered:(Multiple options possible)10A. Allopathy:
General, Specialty e.g. Medicine, Surgery, Pediatrics etc.,Super-specialty e.g. Plastic Surgery,Pediatric Surgeryetc., Dental; or Any other Allopathy(Please specify__________________________________)
Ayurveda: AusadhChikitsa, Shalya Chikitsa, Shodhan Chikitsa, Rasayana, PathyaVyavastha;Any other Ayurveda(Please specify______________________________________________________)10C. Unani: Matab,
Jarahat, Ilaj-bit-Tadbeer, Hifzan-e-Sehat,Any other Unani(Please specify_________________________________________________)
Maruthuvam, Sirappu Maruthuvam, Varmam Thokknam & Yoga,Any other Siddha(Please specify_________________________________________________________ )
Homeopathy:General Homeopathy,Any other Homeopathy(Please specify_________________________________________________________)10F. Naturopathy:
External Therapies with natural modalities, Internal Therapies,Any other Naturopathy(Please specify______________________________________________________)
Yoga: AshtangYoga, Any other Yoga(Please specify______________________________________________________ )|-| 11. Servicefacilities offered:11A. Uni-facility,
or Multi-facility
If uni-facilitythen, service facility offered: Outpatient based Service, orInpatient based service, or Diagnostic laboratory service, orDiagnostic Imaging service,
If multi-facilitythen, service facility offered (Multiple options possible):Outpatient based Service, and Inpatient based service, andDiagnostic laboratory service, and Diagnostic Imaging service11D. This is a single doctor establishment: Yes, No
|-| 12. Sanitation andhygiene requirements (Part I):12A. Drinking water
supply as per standard norm provided: Yes, No12B. Toilet is
adequate Yes, No12C. Whether the
Lighting is adequate: Yes, No
Whether the Ventilation is adequate: Yes,No|-| 13. Mandatoryreport and registers requirements (Part I):1. Reports of
National/state health programmes: Not applicable, Applicable butnot submitted, submitted and copy of acknowledgement receipt(only in case of renewal) enclosed as 13A2. enclosure3. Reports of
notifiable diseases: Not applicable, Applicable but notsubmitted, submitted and copy of acknowledgement receipt (onlyin case of renewal) enclosed as 13A4. enclosure1.
Service/Out-patient register: generated/maintainednotgenerated/maintained2. Inspection book
(register)generated/maintainednot generated/maintained notapplicable3. Police intimation register
generated/maintainednot generated/maintained not applicable|-| 14. Mandatorydisplay requirements (Part I):14A. Signboard at
entrance and other places1. The name and
address of the establishment: Displayed, Not displayed2. Clinical
establishment license Number: Displayed, Not displayed, Notapplicable (in case of new)1. Copy of
clinical establishment license(s): Displayed, Not displayed,Not applicable (in case of new)2. The system(s)
of Medicine practiced: Displayed, Not displayed3. Types and availability of health care and
other services: Displayed, Not displayed|-| 15. License Fee:1. Claim for
exemption due to locality [under rule 40(5)]: Yes, No; if yes2. Supporting
document enclosed as enclosure no.3. Claim for
exemption due to free treatment/concession [under rule 40(8)]:Yes, No; if yes4. Supporting
document enclosed as enclosure no.15B. License fee
deposited with the application1. Amount Rs.deposited vide 15B2. Challan Noand
4. The copy of
Treasury Challan enclosed as enclosure No.15.
C. Subsequentadditional license fee deposited as directed by the licensingauthority1. Amount Rs.deposited vide 15C2. Challan Noand
4. The copy of Treasury Chalan enclosed as
enclosure No.|}
| Part-B |
|
(Only for establishments other than SingleDoctor Establishments solely used for the purpose of consultationand advice)
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16. Particulars ofownership:16A. IndividualProprietorship, Collective proprietorship or company ororganization16B. If Collectiveproprietorship or company or organization, the nature oforganization: Registered Partnership; Registered Company;Corporation; Trust (including Charitable); Organizationregistered under society registration Act; Any otherorganization16B. In case ofCollective proprietorship or company or organization, suchorganization is registered under a Central, Provincial or StateAct ________________________________ (Please specify)16C. Name of suchorganization:16D. Supportingdocument for above statement enclosed as enclosure No.16E.In case ofCollective proprietorship or company or organization, suchorganization is a branch of a Foreign Service provider or not:Yes, No16F. Name of theCompany (in case of collective proprietorship):16G. Address of thecompany (in case of collective proprietorship):16G1.16G2. Pin Code:17G3.PS:17G3. District :16G4. E.mail ID:16G5. Ph No. (Office)17G6. (Residence)16G7. (Mobile)16G8. Nearest Landmark:
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17. Particulars ofservice sub-Facilities offered:17A. In case ofOutpatient based Service:17A1. Solo clinic,17A2. Polyclinic, 17A3. Dental Clinic, 17A4. Acupuncture Clinic, 17A5. Physiotherapy Clinic, 17A6. Occupational therapy Clinic, 17A7., 17A8. Wellness/Fitness centre/clinic, 17A9. CounselingCentre, 17A10. any other clinic or OPD based service centre(Please specify____________________________________________________);17B. In case ofInpatient based Service:17B1. InfertilityClinic, 17B2. Dialysis Centre, 17B3. MTP clinic, 17B4. Anyother Day care centre(Please specify_________________________________________________);17B5.Maternity Home,17B6. Nursing Home/Hospital/Sanatorium, 17B7 Any other IPD basedservice centre(Please specify____________________________________________________ )17C. In case ofPathology laboratory service:17C1. Collectioncentre, 17C1. Small Laboratory, 17C3. Medium Laboratory, 17C4.Large Laboratory,17C5. Geneticlaboratory, 17C6. Any other Pathology laboratory service(Please specify______________________________________________________)17D. In case ofDiagnostic Imaging service:17D1. X-Ray lab (Conventional), 17D2. X-Ray lab(Digital), 17D3. Mamography lab, 17D4. Bone Densitometry lab,17D5. Ultrasonography lab, 17D6. Colour Doppler Imaging lab,17D7. CT Scan lab, 17D8. Magnetic Resonance Imaging (MRI) lab,17D9. Positron Emission Tomography (PET) Scan lab, 17D10.Echo-cardiography lab, 17D11. ECG lab, 17D12. EEG lab, 17D13.EMG lab, 17D14. Other Clinical physiology lab(Please specify______________________________________________________ ), 17D15.Any other Imaging Centre(Please specify____________________________________________________)
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18. Particulars ofOPD based Service (if any):18A. Provided, Notprovided, if provided then:18B. Practice:General Practice, Specialty Practice, Maternity Practice18C. SpecialtyServices: Single, Multispecialty, Super-specialty18D. No. ofConsultation Room: 19D1. Existing:; 19D2. Proposed:;18E. Name of the Specialties:18E1. Specialty 1:18E2. Specialty 2:18E3. Specialty 3:18E4. Specialty 4:18E5.Specialty 5:18E6. Specialty 6:18E7. Particulars for anyadditional Specialty is enclosed as separate sheet in enclosure
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19. IPD basedService (if any):19A. Provided, Notprovided, if provided then:19B. Practice:General Practice, Specialty Practice, Maternity Practice19C. SpecialtyServices: Uni-specialty, multispecialty, Super-specialty19D. Service:Operation Theatre, Maternity, Emergency Casualty, Special careUnit19E. Name of theSpecialties:19E1. Specialty 1:19E2. Specialty 2:19E3. Specialty 3:19E4. Specialty 4:19E5.Specialty 5:19E6. Specialty 6:19E7. Particulars for anyadditional Specialty is enclosed as separate sheet in enclosure
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20. Particulars ofRegulation/SOP of Clinical Establishment:20A. Availableand a copy of such regulationenclosed as enclosure No.; 20B. Not available
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21. Accommodationrequirements:21A. Premisesownership: 21A1. Owned, Rented, Leased, Granted rent free bythe owner of the premisesand 21A2. Copy of Rent receipt,agreement or any such supporting document enclosed as enclosure21B. Consent letterfrom owner of premises: 21B1. Not applicable, applicableand21B2. a copy enclosed as enclosure21C. Plan forconstruction or modification approved by the AppropriateAuthority: 21C1.Not obtained orObtainedand 21C2. a Copy ofapproved Plan enclosed as enclosure No.;21D. Buildingcompletion certificate issued by the Appropriate Authority: 21D1.Not obtained, or Obtainedand21D2. Copy ofBuilding completion certificate enclosed as enclosure No.21E. The tax receipt[property tax] form the Local body: 21E1.Not available, oravailable and 21E2. a copy enclosed as enclosure No.21F. Premises separate from rooms or spaces forprivate uses or other commercial uses: yes, no
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22. Bed strength :22A. Bed strength(excluding Special care/therapy facilities beds: 22A1. Existing:,22A2. Proposed:22B. Specialcare/therapy facilities beds: 22B1.Existing bed strength:,22B2. Proposed bedstrength:22C. Specialcare/therapy facilities beds breakup:22C1. IntensiveCare/Therapy unit: 22C1A. Existing bed strength:;22C1B. Proposed bedstrength:22C2. IntensiveCoronary care Unit: 22C2A. Existing bed strength:;22C2B. Proposed bedstrength:22C3. IntensiveNeonatal care Unit: 22C3A. Existing bed strength:;22C3B. Proposed bedstrength:22C4. High DependencyUnit: 22C4A. Existing bed strength:; 22C4B. Proposed bedstrength:;22C5. NuclearMedicine therapy Unit: 22C5A. Existing bed strength:;23C5B. Proposed bedstrength:22C6. Any othercare/therapy unit ___________________________ (to be specified bythe applicant):22D. Total bed strength:; 21I1. Existing:,21I2. Proposed:
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23. Layout, designand space requirements:23A. SeparateReception Counter: Yes, No23B. Separate Waitingroom/space/area: Yes, No23C. Separate Recordroom: Yes, No23D. Sketch mapshowing detailed position and floor measurement enclosed asenclosure No.23E. Entrance area:Adequate, not adequate23F. Ambulatory area:Adequate, not adequate, not applicable23G. Diagnostic areaAdequate, not adequate, not applicable23H. Intermediatearea Adequate, not adequate, not applicable23I. Critical areaAdequate, not adequate, not applicable23J. Service area Adequate, not adequate
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24. Sanitation andhygiene measures requirements (Part II) :24A. General watersupply as per standard norm provided: Yes, No24B. Drainage systemas per standard norm provided: Yes, No24C. General wastedisposal arrangement as per standard norm provided: Yes, No24D. Separate coolingarrangement: Central AC, Separate AC, Fans24E. The type ofDrinking Water Supply: Piped Water SupplyUnderground Others24F. Whether thequantity of Drinking water is Adequate: Yes, No24G. Whether thequality of Drinking water is satisfactory: Yes, No24H. Sanitaryfitments as per standard norm provided: Yes, No24I. Water closetsNumber: 25I1. For Male, 25I2. For Female, 25I3. Common24J. Lavatory Number: 25J1. For Male, 25J2. ForFemale, 25J3. Common
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25. Safety andSecurity:25A. Authorizationfrom Pollution Control Board for biomed waste handling: 25A1.applicable, Not applicable, if applicable then: 25A2. Alreadyobtained and the copy of Authorization enclosed as enclosure No.; Not obtained but self-declaration in the form of an affidavitenclosed as enclosure No.25B. Method oftreatment and/or disposal of Bio-medical waste: Through CommonFacility, Onsite Facility, Any other (please specify:_______________________________________________________)25C. Backup ElectricSupply: Generator, Invertors, None25D. Electricalarrangements as per standard norm provided: Yes, No25E. Authorization /No Objection Certificate (NOC) /License of Fire safety: 25E1.applicable, Not applicable, if applicable then: 25E2. Alreadyobtained and the copy of Authorization enclosed as enclosure No.; Not obtained but self-declaration in the form of an affidavitenclosed as enclosure No.25G. Biosafetyarrangements as per standard norm provided: Yes, No25H. Authorization /No Objection Certificate (NOC) /License of AERB: 25H1. applicable, Not applicable, if applicable then: 25H2. Already obtained andthe copy of Authorization enclosed as enclosure No.; Notobtained but self-declaration in the form of an affidavitenclosed as enclosure No.25I. adequateSecurity arrangement available: Yes, No25J. Certificate ofEnlistment particulars25J1. Applied forandthe copy of application enclosed as enclosure No.or25J2. Alreadyobtainedand the copy of Trade License enclosed as enclosure No.and25J3. Trade LicenseNumber:and25J4. Name of theIssuing Authority:and26J5. Date of issue:
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26. Mandatoryreporting requirements (Part II):26A. Performancereport: 26A1. Not submitted, submitted and copy ofacknowledgement receipt (only in case of renewal) enclosed as26A2. enclosure26B. Reports relatedprocedures like MTP: 26B1. Not applicable, Applicable but notsubmitted, submitted and copy of acknowledgement receipt (onlyin case of renewal) enclosed as 26B. enclosure26C. Annual reportsof free treatment and concession: 26A1. Not applicable,Applicable but not submitted, submitted and copy ofacknowledgement receipt (only in case of renewal) enclosed as26A2. enclosure26D. Reports ofsentinel events: 26D1. Not submitted, submitted and copy ofacknowledgement receipt (only in case of renewal) enclosed as26D2. enclosure26E.Reports of extract of grievance redressalregister: 26E1. Not applicable, Applicable but not submitted,submitted and copy of acknowledgement receipt (only in case ofrenewal) enclosed as 26E2. enclosure
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27. MandatoryDisplay requirements (Part II):27A. Display board :27A1. Name, govt.designation, hrs of availability of part-time govt. staff:Displayed, Not displayed, Not applicable27A2. Name,qualification and hours of availability of medical staff:Displayed, Not displayed27A3. Current bedoccupancy status and availability of beds: Displayed, Notdisplayed, Not applicable27A4. Certificate ofarrangement or affiliation with reference lab: Displayed, Notdisplayed, Not applicable27A5. License/ NoObjection Certificate (NOC) /Approval of different Acts likePC-PNDT Act: Displayed, Not displayed, Not applicable27A6. Item-wisecharges (Rate-chart) for all services: Displayed, Not displayed27A7. Mechanism toavail concession or free treatment facilities: Displayed, Notdisplayed, Not applicable27A8. StandardCharter of patient rights: Displayed, Not displayed27A9. Informationrelated to Grievance redressal system: Displayed, Not displayed, Not applicable27B. InformationBrochure :27B1. InformationBrochure not available, availableand a copy enclosed asenclosure27B2. If available,Brochure contains adequate information: Yes, No27C. Signage system :27C1. Biohazardsymbols: Displayed, Not displayed, Not applicable27C2. Other signages: Adequate, Not Adequate
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28. Mandatoryregister requirements (Part II):28A. For all clinicalestablishment (other than single doctor establishments):28A1. Dead stockregister: generated/maintainednot generated/maintained28A2. Book ofaccounts: generated/maintainednot generated/maintained28A3. Cashbook:generated/maintainednot generated/maintained28A4. Grievanceregister: generated/maintainednot generated/maintainednotapplicable28A5. Record keepingregister: generated/maintainednot generated/maintained28A6. Lab Register:generated/maintainednot generated/maintainednot applicable28B. For all clinicalestablishment having in-patient facilities :28B1. In-patientregister: generated/maintainednot generated/maintained28B2. Birth Register:generated/maintainednot generated/maintainednot applicable28B3. Death Register:generated/maintainednot generated/maintained28B4. OT logbook(register): generated/maintainednot generated/maintainednotapplicable28B5. Register(s)related to procedure under Acts like MTP Act under rule 13generated/maintainednot generated/maintainednot applicable28B6. Record ofhealth case sheet/BHT: generated/maintainednotgenerated/maintained28B7. Referralregister: generated/maintainednot generated/maintained28B8. Records of free treatment/concessiongenerated/maintainednot generated/maintainednot applicable
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29. Equipment andMedical supplies requirements:29A. Equipmentavailability: Adequate, not adequate29B. Equipmentregister: generated/maintained, not generated/maintained29C. Medical suppliesavailability: Adequate, not adequate29D. Medical supplies stock book: generated/maintained, not generated/maintained
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30. Education andResearch particulars:30A. Whether intendto conduct (or conducting) research: Yes, No;30B. If yes then NoObjection Certificate (NOC): 33B1. Not obtained,or obtained;and 33B2. a copy of No Objection Certificate (NOC) enclosed asenclosure30D. Whether intendto conduct (or conducting) training/education: Yes, No;30E. If yes then No Objection Certificate (NOC):33B1. Not obtained, or obtained; and 33B2. a copy of NoObjection Certificate (NOC) enclosed as enclosure
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31. Manpowerrequirements (Medical Staff) :31A. Number: 31A1.No. of Full-time Medical staff, 31A2 No. of Part-time MedicalStaff31A3. Total31B. Types of medicalstaff: 31B1. Consultant31B2. RMO 31B3. Total31C. Shift duty ofRMO (in case of IPD only): No. of shift per 24 hr cycle:31D. Particulars ofindividual medical staff---------------------------------------------------------------------------------------------------------------------------------31D 01A. Name31D 01B.Qualification (Highest):31D 01C. Name of theUniversity:31D 01D. CopyCertificate of qualification enclosed as enclosure31D 01E. RegistrationNo.31D 01F. Name of theCouncil registered with:31D 01G. CopyCertificate of registration enclosed as enclosed31D 01H. Designationas per offer letter:31D 01J. Type:Full-time, Part-time, only empanelled31D 01K. Alreadyengaged by any Public sector agency: Yes, No; If yes NoObjection Certificate (NOC) enclosed as enclosed No.31D 01L. Alreadyengaged by any Private sector agency: Yes, No; If yes Number ofsuch agencies31E. Particular for any additional staff isenclosed as separate sheet in enclosed
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32. Manpowerrequirements (Nursing Staff):32A. Number: 32A1.No. of Full-time Nursing staff, 32A2. No. of Part-time NursingStaff32A3. Total32B. Shift duty ofnursing Staff (in case of IPD only): No. of shift per 24 hrcycle:32C. Particulars ofindividual Nursing staff-----------------------------------------------------------------------------------------------------------------------------------32C 01A. Name32C 01B.Qualification (Highest):32C 01C. Name of theUniversity:32C 01D. CopyCertificate of qualification enclosed as enclosure32C 01E. RegistrationNo.32C 01F. Name of theCouncil registered with:32C 01G. CopyCertificate of registration enclosed as enclosure32C 01F. Copy ofOffer letter enclosed as enclosure32C 01G. Copy ofAcceptance letter enclosed as enclosure32C 01H. Designationas per offer letter:32C 01J. Type:Full-time, Part-time, only empanelled32C 01K. Alreadyengaged by any Public sector agency: Yes, No; If yes NoObjection Certificate (NOC) enclosed as enclosure No.32C 01L. Alreadyengaged by any other Private sector agency: Yes, No; If yesNumber of such agencies32D. Particulars for any additional staff isenclosed as separate sheet in enclosure
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33. Manpowerrequirements (Allied-medical Staff):33A. Number: 33A1.No. of Full-time Allied-medical staff, 33A2. No. of Part-timeAllied-medical Staff33A2. Total33B. Particulars ofindividual Allied-medical staff-----------------------------------------------------------------------------------------------------------------------------------33B.01A. Name33B.01B.Qualification (Highest):33B.01C. Name of theUniversity:33B.01D. CopyCertificate of qualification enclosed as enclosure33B.01E. RegistrationNo.33B.01F. Name of theCouncil registered with:33B.01G. CopyCertificate of registration enclosed as enclosure33B.01F. Copy ofOffer letter enclosed as enclosure33B.01G. Copy ofAcceptance letter enclosed as enclosure33B.01H. Designationas per offer letter:33B.01J. Type:Full-time, Part-time, only empanelled33B.01K. Alreadyengaged by any Public sector agency: Yes, No; If yes NoObjection Certificate (NOC) enclosed as enclosure No.33B.01L. Alreadyengaged by any other Private sector agency: Yes, No; If yesNumber of such agencies33C. Particulars for any additional staff isenclosed as separate sheet in enclosure
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34. Manpowerrequirements (Paramedical Staff):34A. Number: 34A1.No. of Full-time Paramedical staff,34A2. No. ofPart-time Paramedical Staff34A2. Total34B. Particulars ofindividual Paramedical staff----------------------------------------------------------------------------------------------------------------------------------34B.01A. Name34B.01B.Qualification (Highest):34B. 01C. Name of theUniversity:34B.01D. CopyCertificate of qualification enclosed as enclosure34B.01E. RegistrationNo.34B.01F. Name of theCouncil registered with:34B.01G. CopyCertificate of registration enclosed as enclosure34B.01F. Copy ofOffer letter enclosed as enclosure34B.01G. Copy ofAcceptance letter enclosed as enclosure34B.01H. Designationas per offer letter:34B.01J. Type:Full-time, Part-time, only empanelled34B.01K. Alreadyengaged by any Public sector agency: Yes, No; If yes NoObjection Certificate (NOC) enclosed as enclosure No.34B.01L. Alreadyengaged by any other Private sector agency: Yes, No; If yesNumber of such agencies34C. Particulars for any additional staff isenclosed as separate sheet in enclosure
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35. Manpowerrequirements (General Duty Attendant) :35A. Number: 35A1.Full-time General Duty Attendant staff,35A2.Part-timeGeneral Duty Attendant Staff35A3. Total;35B. Outsourced: Yes, No, If yes agreement copy enclosed as enclosure No.35C. Particulars ofindividual General Duty Attendant staff----------------------------------------------------------------------------------------------------------------------------------35C 01A. Name35C 01B. Ageyrs,35C 01C. Sex (M/F):,35C 01D.Qualification (Highest):35C 01E. Copy ofOffer letter enclosed as enclosure35C 01F. Copy ofAcceptance letter enclosed as enclosure35C 01G. Designationas per offer letter:35D. Particulars for any additional staff isenclosed as separate sheet in enclosure
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36. Manpowerrequirements (Administrative-Managerial staff) :36A. Chief ExecutiveOfficer designated: 36A1. Applicant himself, 36A2. Any otherstaff, if other staff36B. Particulars36B1. Name36B2. Ph (Office)36B3. Mobile36B4. E.mail ID:36C. GrievanceRedressal Officer designated: 36C1. Applicant himself,36C2. Any other staff, if other staff36D1. Name36D2. Ph (Office)36D3. Mobile36D4. E-mail ID:
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37. StaffAttendance/availability:37A. Staff Register:generated/maintainednot generated/maintained37B. Staffrequirement:37B1. No. of medicalstaff provided as per norm: Yes, No37B2. No. of Nursingstaff provided as per norm: Yes, No37B3. No. ofAllied-medical staff provided as per norm: Yes, No37B4. No. ofPara-medical staff provided as per norm: Yes, No37C. Staff Attendanceregister: generated/maintainednot generated/maintainedbiometricattendance37D. Staffavailability on duty:37D1. No. of medicalstaff provided as per norm: Yes, No37D2. No. of Nursingstaff provided as per norm: Yes, No37D3. No. ofAllied-medical staff provided as per norm: Yes, No37D4. No. of Para-medical staff provided as pernorm: Yes, No
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| Part-D |
| (For all clinical establishments) |
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38. Affidavit:Self declaration andundertaking in the form of Affidavit as per Statutory CE Form IIIenclosed as enclosure
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39. Any additional information furnished bythe applicant:
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40. DeclarationI,Sri/Smt/Kum/Dr._______________________________________________son/daughter/wifeof________________________________________________________age_______________years, residentof___________________________________________________ herebydeclare that I have read and understood the West Bengal ClinicalEstablishment (Registration, Regulation and Transparency) Act,2017 (West Bengal Act IV of 2017) and as per the West BengalClinical Establishment (Registration, Regulation andTransparency) Rules, 2017.I also undertake to explain the saidAct and Rules to all employees/consultants of the clinicalestablishment in respect of which registration is sought and toensure that the Act and Rules are fully complied with.{|
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| Date: |
(________________________) |
| Place: |
Name and Signature of Applicant. |
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Partner, Director, Trustee, Secretary, Presidentor Chairman of that partnership firm, company, trust ororganization but shall not include an employee of that firm,company, trust or organization.
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I, being the proprietor or a signatoryauthorized by the board of partners/ directors/ trustees/executive committee of the firm/ company/ trust/ organizationcompany, in terms of rule 44 of the West Bengal ClinicalEstablishment (Registration and Regulation) Rules, 2017, dohereby give notice that the following person, being a partner/director/ trustee, secretary/ president/chairman of this firm/company/ trust/ organization, is nominated as the applicant inrespect of clinical establishment mentioned and shall bein-charge of establishment and shall be responsible and liablefor any contravention of the Act and rules/regulations ordirections issued thereunder in respect of this establishment.
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The nominated applicant shall take all suchsteps as may be necessary to prevent the commission by theCompany of any contravention under and comply with the provisionsof the Act and the Rules and Regulations made thereunder.
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Name of theEstablishment :.............................................................................................................................Name of the nominated applicant:....................................................................son/daughter/wife/of................................. residing at.......................................................................Full signature of the nominated applicant....................................................................................A certified copy of the resolution of the board regarding theauthorized signatory, dated _____________ is enclosed.{|
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| Place:______________ |
For ______________ (Name of the Company.) |
| Date:______________ |
Authorized signatory of the company |
| Self-Declaration |
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I,Mr./Mrs./Ms/Dr.__________________________________________________________son/daughter/wifeof_______________________________________________________________age_____________ years, resident of________________________________________________________ herebydeclare that the statements and particulars furnished by me inClinical Establishment Form I as per rule 34 of the of the WestBengal Clinical Establishment (Registration, Regulation andTransparency) Rules, 2017 in respect of the ClinicalEstablishment______________________________________________________________________________(Name) situated at__________________________________________________________________________________(address)has been made correctly and I would make myself liable forappropriate legal action including suspension or cancellation oflicense in case any of the statements or particulars furnished byme are found false or incorrect thereof subsequently oninspection by the authorized representative of the licensingauthority.
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I also undertake to correct deficiencies, ifany, as per the said Act and Rules.
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| {| |
| Place : |
(________________________________) |
| Date : |
Signature of Applicant. |
| [See rule 35] |
| Office Address of the Licensing Authority |
| {| |
| Memo No. |
Date: |
| Place : |
Signature of the Officer in-charge |
| Date : |
Office Seal with designation |
| [See rule 35] |
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01. Application form attached: Yes, Notapplicable(in case of unregistered establishment)
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02. Name and Address of the clinicalestablishment inspected :.................................................................
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03. Name and Address of theApplicant/Licensee/Occupier :............................................................
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04. Inspection Remarks: Cannot be verified,Checked and verified, and found acceptable; or found notacceptable as noted below under note No.
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05. Inspection Note:The above mentioneditems claimed by the applicant in the application form cannot beverified.After verification ofother items, the following discrepancies are noted below:[Please begin each para with a two digit notenumber corresponding to note number already mentioned indifferent remarks]
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06. Recommendations:06A. Improvementnotice may be issued; 06B. Prohibition notice may be issued;06C. Suspension order may be issued; 06D. Cancellation order maybe issued; 06E. Complaint may be lodged with the adjudicatingauthority 06F. Application may be refused06G. Application may begranted06H. Any other recommendation(s)(please specify below):
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| {| |
| Date : |
Signature of the Inspection Officer/Authority |
| Place : |
Office seal |
| Remarks of the Licensing Authority |
| Date : |
Signature of the Licensing Authority |
| Place : |
Office seal |
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01. Application Acknowledgement:00A. AcknowledgementNo.00B. Acknowledgement Date
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02. Name of the Clinical Establishment:...................................................................................
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03. ExistingClinical Establishment License Number (if any):03A. License 1:,03B. License 2:,
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04. Address of the Clinical Establishment:Pin Code PS E.mail ID Ph No. (Office) (Mobile).............................................................................................................................................................................................
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05. Name of thelocal Body:...................................................................................................Corporation, or Municipality, or notified area; or Panchayat Area
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06. Location:Metropolitan, or Urban ,or Rural
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07. Name of the Applicant: Title .......First ............. Middle ..................... Last...........................
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08. Address of the ApplicantPin Code PSE.mail ID Ph No. (Office) (Mobile).........................................................................................................................................................................................................
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09. Nature ofownership/occupant :09A. Individual Proprietorship, or RegisteredPartnership, or Registered Companyor Corporation (including asociety) registered under a Central, Provincial or State Act(Please specify .......); orTrust (including Charitable)registered under a Central, Provincial or State Act(Pleasespecify .............); Branch of a Foreign Service provider(Please specify ...............); or Any other(Please specify............) 09B. Name of the Company:................................................................................................09B.Address of the Company Pin Code PS E.mail ID Ph No. (Office)(Mobile..........................................................................................................................................................................................................................................................................)
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| Classification |
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10. System of Medicine Offered:(Multipleoptions possible)Allopathy, Ayurveda, Unani, Siddha,Homeopathy, Naturopathy, Yoga ÿ Any other(Please specify...)
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11. Subsystem ofMedicine Offered:(Multiple options possible)11A. Allopathy:General, Specialty, Super-specialty, Dental; or otherAllopathy(Please specify ...)11B. Ayurveda:AYR01, AYR02, AYR03, AYR04, AYR05; AYR06(Please specify................)11C. Unani:UNN01, UNN02, UNN03, UNN03, UNN04, UNN05(Please specify...............)11D. Siddha:SDD01, SDD02, SDD03, SDD04(Please specify............................................)11E. Homeopathy:HOM01, HOM02(Please specify.................................................................)10F. Naturopathy:NTR01, NTR02NTR03(Please specify.....................................................)10G.Yoga:YOG01, YOG02(Please specify............................................................................)
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12. ServiceFacilities offered:12A. Uni-facility,or Multi-facility12B. If uni-facilitythen, service facility offered: Outpatient based Service, orInpatient based service, or Diagnostic laboratory service, orDiagnostic Imaging service,12C. Ifmulti-facility then, service facility offered (Multiple optionspossible): Outpatient based Service, and Inpatient based service, and Diagnostic laboratory service, and Diagnostic Imagingservice12D. It is a single doctor establishment: Yes,No,
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13. Servicesub-Facilities offered:(Multiple options possible)13A. In case ofmainly Outpatient based Service:13AA. Solo clinicÿ,13AB. Polyclinic, 13AC. Dispensary, 13AD. Dental Clinic, 13AE.Physiotherapy Clinic, 13AF. Occupational therapy Clinic, 13AG.Infertility Clinic, 13AH. Dialysis Centre, 13AI. MTP clinic,13AJ. Day care centre, 13AK. Wellness/Fitness centre/clinic,13AL. Counseling Centre, 13AM. any other clinic or OPD centre(Please specify ............................................)13B. In case ofmainly Inpatient based Service:13BA. Maternity Home, 13BB.Nursing Home/Hospital,13BC. Sanatoriumÿ,13BD Any other IPD centre(Please specify.............................................)13C. In case ofDiagnostic laboratory service:13CA. Collection centre,13CB. Small Laboratory, 13CC. Medium Laboratory, 13CD. LargeLaboratory13D. In case of Diagnostic Imaging service:13DA. X-Ray Centre(Conventional or Digital) , 13DB.Mamography centre, 13DC. Bone Densitometry centre, 13DD.Sonography centre, 13DE. Colour Doppler Imaging centre, 13DF.CT Scan Centre, 13DG. Magnetic Resonance Imaging (MRI) Centre,13DH. Positron Emission Tomography (PET) Scan Centre, 13DI. Echo, 13DJ. Any other Imaging Centre(Please specify.......................................)
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14. Bed strength:14A. Total Bed strength:14B. Bed strength ofspecial care units:14C. Categories as per total bed-strength forwhich registration is issued: Nil, Up to 30 beds, 30-50 beds,51-100 beds, 101-300 beds, 301-500 beds, More than 500 beds
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15. Particulars related to No ObjectionCertificate (NOC)/License/Approval obtained to perform procedureslike MTP
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16. License Fee:16A1.Amount Rs.deposited and 16A2. Challan Noand 16A3.Date16B1.Amount Rs.refunded and 16B2. Challan Noand 16B3.Date
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17. Other Fees andFines:17A. Amount Rs.deposited and 17B. Challan Noand 17C. Date
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18. ManpowerNumber:18A. Medical Staff, 18B. Nursing Staff, 18C.Paramedical & Allied-medical Staff, 18D. Admin-managerialStaff, 18E. Total Staff
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19. RegistrationDetails:19A. Registration No..........................................................................................................19B. RegistrationDate ...................................... 19C. RegistrationValid upto ....................................19C. Registrated by(Designation of Licensing Authority cum DistrictRegistrar):................................19D. Name of theDistrict:...................................................................................................19E. Order No. issuedby Licensing Authority granting License ..................18F.Dated ........................19F. Period ofirregular running (if any)19F1. From Date19F2. To Date20. Present status:(only in case ofdigital register)20A1. Valid License, 20A2. License expired,20A3. License Suspended, 20A4. License Cancelled21. Any Additional information:Signature and Seal of Licensing Authority
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Statutory CE FORMVII: License[See rule 3]
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| {| |
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Registration/LIcenseNo--
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Original/Duplicate |
2017. vide order issued [by the undersigned] under such number in
respect of such clinical establishment situated at such addressto keep or carry on the said clinical establishment having suchnumber of beds offering such service facilities in suchrecognized system of medicine as mentioned below.|-| 2. This is to certify that the licensee hasbeen Registered vide registration No. as mentioned above underthe Rule 3 of the West Bengal Clinical Establishment Rules,2017.
, [by the undersigned] in respect of the clinicalestablishment as mentioned below and the license shall be validfor the period ........|-| 3. The License is granted subject to the WestBengal Clinical Establishment (Registration, Regulation andTransparency), Act 2017, Clinical Establishment Rules 2017 andany contravention thereon shall result in suspension orcancellation of this license before the expiry period.|-| 4. This is to certify that such amount oflicense fee was collected as mentioned below which isnon-refundable in case of any closure, suspension or withdrawalof any services as mentioned below.|-| 5. This license is non-transferable.|-| 6. Particulars of the Licensee:|-| 6.a. Name of the Licensee:.........................................................................................................|-| 6.b.Son/daughter/wife of:........................................................................................................|-| 6.c. Address of the Licensee:...................................................................................................|-| 7. Particulars of the Establishment:|-| 7.a. Name of the Clinical Establishment:.......................................................................................|-| 7.b. Address of the Clinical Establishment: (Place of Business).........................................................|-| 8.a. Order No. of the Licensing Authority granting License: ..................................|-| 8.b.Date .......................|-| 9. Validity of the license:|-| 9.a. Granted/ Renewed from [Date] ..............|-| 9.b. Valid upto [Date]..............|-| 9.c. Period of irregular running from [Date]...........................|-| 9.d.to [Date] ..........................|-| 10. Stipulated License fee:Rs....................... (Rupees in words)..................................................|-| 11.Service facilities:|-| 11.a. Name(s) of recognized system of medicinepracticed:.......................................................|-| 11.b. Number of beds: General..........................................|-| 11.c.Special care beds ........................|-| 11.d. Types of service facilities to beprovided:.......................................................................|-|
| Place: |
Signature of the Licensing Authority |
| Date: |
DistrictRegistrar |
| |
Office Seal with designation |
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Statutory CE Form VIII: Granting ofApplication Order[See rule 35]
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| Office Address of the Licensing Authority |
| {| |
| Memo No. |
Date: |
| Place: |
Signature of the Licensing Authority &District Registrar
|
| Date: |
Office Seal with designation |
| Office Address of the Licensing Authority |
| {| |
| Memo No. |
Date |
13. of the West Bengal Clinical Establishment (Registration,
Regulation and Transparency) Act, 2017, the Licensing Authority,after providing opportunity of being heard, hereby rejects theapplication mentioned above submitted by the applicant mentionedbelow for grant/renewal of registration of the clinicalestablishment named below situated at the address given below onthe ground stated below.|-| 2.a. Name of the Applicant:...................................................................................................|-| 2.b. Address of the Applicant:................................................................................................|-| 2.c. Name of the clinical establishment:.......................................................................................|-| 2.d. Address of the clinical establishment....................................................................................|-| 2.e. Registration No. of existing License (onlyin case of renewal): ...................................|-| 3. Ground for Rejection:|-|
| Place: |
Signature of the Licensing Authority and DistrictRegistrar
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| Date: |
Office Seal with designation |
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Ref: AuthorizationNotice No......................... Dated .....................In exercise of thepower delegated to me under section 24 of the West BengalClinical Establishment (Registration, Regulation andTransparency), Act 2017 (West Bengal Act IV of 2017), I herebyseize the under mentioned material objects/documents at thepremises of(Name of clinicalestablishment).............................................................located at (addressof place of business)..........................................................................................and kept/occupied by(name of the occupier/proprietor..........................................................................Son/daughter/wife of....................................................................................................................residing at (address of the occupier/proprietor)....................................................................................
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Sl. No. Description1.2.3.Date of seizer:Time of seizer:Place of seizer:Person from whom thematerial objects were seized (name).................................................................Son/daughter/wife of..................................................................................................................residing at (address of the occupier/proprietor)....................................................................................
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The seizure has beenmade and the inventory has been prepared in presence of thefollowing witnesses.Name and address ofthe witness signature.1.2.
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The material objects seized have been dulysealed and are left in the custody ofShri.......................................... Designation................................................. with theinstruction not to tamper with the seals and not to dispose ofthe object till further order.
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This memo is handed over to the person mentionedabove from whom the material objects were seized
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| {| |
| Signature of occupier/proprietor |
signature of the Authorized Officer |
| Name................................................. |
Designation |
| Place-.................................................. |
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| Date:................................................... |
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Statutory CE FormXI: Self-DeclarationSeizure of Vitalrecords[See rule 38]I,...........................................................................................................................,son of/wife of/daughter of................................................................................................,aged about .................... years and residing at.............................................................................dohereby solemnly affirm and sincerely state as follows:1. I am the proprietor/occupier of the clinical establishment at...................... styled as ...................2. I say that on ______ at about ___a.m./p/m., the SupervisoryAuthority,.............................(here give the name anddesignation of the Authorized Officer) inspected/searched thepremises at _________________ where I am keeping/carrying onclinical establishment. During the course of suchinspection/search, the Supervisory Authority has seized certainmedical records, books of account, other relevant documents andrecords.3. I say that the medical records, books of account, otherrelevant documents and records seized during theinspection/search are required for keeping/carrying on clinicalestablishment and hence it is necessary that they be returned tome immediately.4. At my request, the Supervisory Authority has agreed to returnthe books of account and other documents so seized during theinspection/search, subject to my providing him extracts or copiesof such books of account and other documents. The SupervisoryAuthority has given me the details of the extracts or the copiesrequired by him.6. I say that I have caused the extracts/copies so required to betaken in the presence of .......................... (here givethe name & designation of the Authorized Officer).7. I confirm and declare that the extracts/copies annexed to thisAffidavit are the true, authentic and genuine extracts/copies ofbooks of account/other documents seized on _______ and inconfirmation thereof, I have initialed each page of suchextracts/copies.8. I am aware that based on the solemn declarations given in thisAffidavit, the Supervisory Authority has agreed to return thebooks of accounts and other documents seized as soon as possible.9. I hereby undertake to retain the medical records, books ofaccount, other relevant documents and records in may safe custodywithout causing any dislocation, mutilation, tampering, damage ordestruction to the records in the course of safe-keeping for sucha period as long as necessary.10. I hereby undertake to produce the books of accounts and otherdocuments or any part thereof at any time as may be required bythe Licensing Authority or by the Supervisory Authority or beforeany inquiry proceedings or before any adjudication proceedingsthat may be initiated by the Licensing Authority against me.Name.................................................(signature of thedeponent)Designation.........................................Place-..................................................Date:...................................................
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| Establishment |
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| Name of establishment: |
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| PT Verification No: |
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| Previous License No: |
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| Address of establishment: |
District: |
Local Authority: |
| Municipality: |
Sub Division: |
Block: |
| Landline: |
Mobile: |
Email: |
| Type of Application: |
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| Application Detail |
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| Name of Applicant: |
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| Address of Applicant: |
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| Landline: |
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Mobile: |
| Type of establishment: |
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Date of establishment of Centre, if alreadystarted:
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Renewal for: |
| Nature of firm: |
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| Trade Licence |
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| Name of Authority: |
Licence Number: |
Date of issue: |
| File attached: |
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Affidavit.pdf, Appointment Letters.pdf, ApproveBuilding Plan.pdf, Challan.pdf, Clinical Waste Disposal.pdf,Current Rate Chart.pdf, Electricalinstallation.pdf, Fire NoObjection Certificate (NOC)
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| Licence fees requirement status: |
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| Challan |
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| Challan Number: |
Date: |
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| Amount: |
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| Clearance from pollution control board: |
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Clinical Waste disposal licence (FromPanchayat/Municipality/Municipal Corporation):
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| Premises |
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| Construction approved by authority?: |
Premises Type: |
Reception Counter: |
| Waiting Room: |
Record Room: |
Ventilation Sufficient?: |
| Lighting Sufficient?: |
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| Drinking Water Supply |
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| Source: |
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Quantity: |
| Quality: |
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Cooling Arrangement: |
| Exemption Granted By |
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| Customs Department: |
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H&FW Dept.: |
| Registers (to be maintained) |
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| Staff Register Available: |
Attendance Register: |
Stock Register: |
| Cashbook Register: |
Admission Register: |
Inspection Book: |
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Whether training of medical or paramedicalcourses are present?:
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| Sanitary Arrangement |
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| Drainage System: |
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| Water Closet for Male: |
Water Closet for Female: |
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| Lavatory for Male: |
Lavatory for Female: |
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| System of garbage disposal: |
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| Electric Supply: |
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| Staff |
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| Total number of staffs: |
No. of permanent staff: |
No. of temporary staff: |
| Staff Table |
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| General |
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| Category of Staff- |
Name Qualification Registration |
Name of Nature Appo |
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Faculty of Service |
Letter |
| Declarations |
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| Regarding display of Rate Charges |
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| Doctor's Charges: |
Bed Charges: |
OT Charges: |
| Investigation Charges: |
Service Charges: |
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| Regarding Operation Theatre |
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| Total OT Space: |
List of Equipments: |
Shadow-less Light: |
| Boyle's Apparatus: |
Anaesthetist List: |
Auto Cave: |
| Regarding Maternity Home |
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| Labour Room Space: |
List of Equipments: |
Sucker Machine: |
| Regarding Installation |
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| Regarding Electrical Installation and Supply: |
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Regarding Cooking, Storing and Distribution ofFood for Patients:
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| Regarding Accommodation |
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| Regarding Accommodation of Residential Staff: |
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| Download attachments: |
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| Establishment |
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| Name of establishment: |
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| Address of establishment: |
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Local Authority: |
| Landline: |
Mobile: |
Email: |
| Type of Application: |
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| Application Detail |
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| Name of Applicant: |
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| Address of Applicant: |
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| Landline: |
Mobile: |
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Type of establishment:Nursing Home, OPD Center [ OPDrun by PG Doctors and above - Poly], Other 9HUF, FFA, LASER,ECG&OCT), Pathological Clinic - Small, Nursing Center[OPD runby PG Doctors and above - Poly], Other (HUF, FFA, LASER, ECG &OCT), Pathological Clinic - Small
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| Date of establishment of Centre, if already started: |
Renewal for: |
| Nature of firm: |
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| Trade Licence |
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| Name of Authority: |
Licence Number: |
Date of issue: |
| File attached: |
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Affidavit.pdf, Appointment Letters.pdf, Approve BuildingPlan.pdf, Challan.pdf, Clinical Waste Disposal.pdf, Current RateChart.pdf, Electricalinstallation.pdf, Fire No ObjectionCertificate (NOC)
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| Licence fees requirement status: |
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| Challan |
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| Challan Number: |
Date: |
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| Amount: |
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| Clearance from pollution control board: |
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Clinical Waste disposal licence (FromPanchayat/Municipality/Municipal Corporation):
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| Premises |
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| Construction approved by authority?: |
Premises Type: |
Reception Counter: |
| Waiting Room: |
Record Room: |
Ventilation Sufficient?: |
| Lighting Sufficient?: |
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| Drinking Water Supply |
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| Source: |
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Quantity: |
| Quality: |
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Cooling Arrangement: |
| Exemption Granted By |
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| Customs Department: |
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H&FW Dept.: |
| Registers (to be maintained) |
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| Staff Register Available: |
Attendance Register: |
Stock Register: |
| Cashbook Register: |
Admission Register: |
Inspection Book: |
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Whether training of medical or paramedical courses arepresent?:
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| Sanitary Arrangement |
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| Drainage System: |
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| Water Closet for Male: |
Water Closet for Female: |
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| Lavatory for Male: |
Lavatory for Female: |
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| System of garbage disposal: |
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| Electric Supply: |
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| In Case Of Nursing Home |
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| Expected patient at ESH per Day: |
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Total Number of beds: |
| Number of cabins: |
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Space for each patient: |
| Number of cubicle: |
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Space for each patient: |
| Number of wards: |
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Space for each patient: |
| Number of beds in ICCU: |
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Space for each patient: |
| Number of beds in ITU |
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Space for each patient: |
| Number of beds in RCU: |
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Space for each patient: |
| Number of beds in NCU: |
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Space for each patient: |
| Number of beds in Dialysis Unit: |
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Space for each patient: |
| Number of beds in Other Units: |
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Space for each patient: |
| Space for OT: |
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Space for Labour Room: |
| Staff |
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| Total number of staffs: |
No. of permanent staff: |
No. of temporary staff: |
| Staff table |
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| General |
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| Category of Staff |
Name Qualification |
Name of Nature Appo |
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Registration |
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| Number |
Faculty of Service |
Letter |
| Declarations |
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| Regarding display of Rate Charges |
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| Doctor's Charges: |
Bed Charges: |
OT Charges: |
| Investigation Charges: |
Service Charges: |
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| Regarding Operation Theatre |
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| Total OT Space: |
List of Equipments: |
Shadow-less Light: |
| Boyle's Apparatus: |
Anaesthetist List: |
Auto Cave: |
| Regarding Maternity Home |
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| Labour Room Space: |
List of Equipments: |
Sucker Machine: |
| Regarding Installation |
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| Regarding Electrical Installation and Supply: |
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Regarding Cooking, Storing and Distribution of Food forPatients:
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| Regarding Accommodation |
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| Regarding Accommodation of Residential Staff: |
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| Download attachments: |
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I accept on behalf of myself and the company/association/bodyhereby declare that the statements above are correct and true tomy knowledge and I shall abide by all the rules and declarations(from A to F as stated above) in respect of my clinicalestablishment, that already exists / proposed to be established.
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I further declare that this clinical establishment is not andwill not be used for immoral purpose.
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I undertake that I shall intimate to the Licensing Authorityany change in the particulars given above.
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| Before the Hon'ble Appellate Authority |
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Memorandum of Appeal No. .....................................Dated...................... [Office Use only]
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| In The Matter Of |
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Name of the Appellant(s) :..............................................................................................................
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Son/daughter/wife of:....................................................................................................................
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Full Address:...............................................................................................................................
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Village/Tehsil/District:...................................................................................................................
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| Against the decision ofDesignation of the Licensing authority: |
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Full Address:..............................................................................................................................
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District:-..................................................................................................................................
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The humble appeal of Appellant(s) above named mostrespectfully sheweth:
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1. This appeal is directed under Section 26 of the West BengalClinical Establishments (Registration, Regulation andTransparency) Act, 2017 against the order of the DistrictRegistrar & Licensing Authority ...........................in order No. ...................... passed on......................... received by the appellant on...........................
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2. This appeal is filed within the time limit provided underrule 41 of the West Bengal Clinical Establishments (Registration,Regulation and Transparency) Act, 2017 This appeal being, barredby limitation, is accompanied by an application for condonationof delay for consideration by the Appellate Authority, as persection 26 of the West Bengal Clinical Establishments(Registration, Regulation and Transparency) Act, 2017 (deletewhichever is not applicable).
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3. Brief facts of the case are stated hereunder (Pleasefurnish herein the details of the case and the decision of theDistrict Registrar and Licensing Authority):........................................................................................
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4. The grounds on which the appeal is preferred are statedhere under (the grounds should be numbered consecutively withoutany arguments of narrative):.............................................................................................
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5. The appellant has not preferred any other appeal againstthe order impugned herein.
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6. Prayer: It is, therefore, respectfully prayed that yourHonour may be graciously pleased to allow the appeal and setaside/modify the order of the District Registrar and LicensingAuthority appealed against.
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| 7. List of enclosures: |
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1. Certifiedcopy of the order of the District Registrar and LicensingAuthority appealed against.
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2.Affidavit.
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3..............................................
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4..............................................
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Place:...................
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| Date: .................... |
Full Signature |
VII
License Fees[See rule 40]Part I – General
1. The clinical establishment shall submit the License Fees as specified in this schedule.
1.2While computing the license fees, the type(s) of service facilities offered by the clinical establishment should be considered and taken together.Illustration 1. The license registration fee for a clinical establishment having X-Ray Lab (conventional) and a Ultrasonography lab should be Rs.10,000 plus Rs.10,000 that is altogether Rs.20,000.Illustration 2. The license registration fee for a clinical establishment having 10 bedded inpatient facilities with a X-Ray Lab (conventional) should be Rs.10,000 plus Rs.10,000 that is altogether Rs.20,000.1.3While computing the license fees, the total number of beds including beds of special care units and emergency observation beds should be considered together.Illustration 1. The license registration fee for a clinical establishment having 15 bedded inpatient facilities should be Rs.10,000 plus Rs.500 into 5 that is altogether Rs.12,500.Illustration 2. The license registration fee for a 15 bedded nursing home having 10 general beds and 5 ITU beds should be Rs.10,000 plus Rs.3,750 that is altogether Rs.13,750.Part II – . Specific
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Type of Establishment |
License Fee in License Fee in Rs. forRegistration
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Rs. for Renewal |
| 1. |
Outpatient based Service |
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| 1.A. |
Solo clinic - only for consultation and advice by a registeredmedical practitioner
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Nil |
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| 1.B. |
Solo clinic- used for medical practice and treatment by aregistered medical practitioner other than 1 A as above
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5,000 |
3,000 |
| 1.C. |
Polyclinic |
5,000 per specialty /super specialty |
3,000 per specialty/super specialty |
| 1C. |
Dental Clinic/ Refraction clinic/ Acupuncture clinic/Physiotherapy Clinic / Other Medical clinic with facilities forprocedure
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10,000 |
7,000 |
| 1.D. |
Occupational therapy Clinic |
10,000 |
7,000 |
| 1.E. |
Wellness/Fitness centre/clinic |
15,000 |
10,000 |
| 1.F. |
Counseling Centre |
10,000 |
7,000 |
| 1.G. |
Any other OPD based Service centre |
5,000 per specialty/super specialty |
3,000 per specialty/super specialty |
| 2.A |
Inpatient based service as day care centers: InfertilityClinic, Dialysis Centre, MTP Clinic, Any other Day care Centre
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| 2.A.1. |
Up to 10 beds |
10,000 |
7,000 |
| 2.A.2. |
11 beds and more |
500 per additional bed |
300 per additional bed |
| 2.B |
Inpatient based service: Maternity Home/ NursingHome/Hospital/ Sanatorium/ Any other IPD based service centre
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| 2.B.1. |
Up to 10 beds (excluding special care/therapy beds) |
10,000 |
7,000 |
| 2.B.2. |
11 beds and more beds (excluding special care/therapy beds) |
750 per additional bed |
500 per additional bed |
| 2.C. |
Special Care unit (additional fees) |
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| 2.C.1. |
Critical Therapy unit (in addition to normal beds) |
750 per bed |
500 per bed |
| 2.C.2. |
Intensive Coronary care Unit (in addition to normal beds) |
750 per bed |
500 per bed |
| 2.C.3. |
Intensive Neonatal care Unit (in addition to normal beds) |
500 per bed |
300 per bed |
| 2.C.4. |
Any other Special Care unit (in addition to normal beds) |
750 per bed |
500 per bed |
| 3. |
Pathology laboratory service |
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| 3.A. |
Small Laboratory |
5,000 |
3,000 |
| 3.B. |
Medium Laboratory |
10,000 |
7,000 |
| 3.C. |
Large Laboratory |
20,000 |
15,000 |
| 3.D. |
Collection Centre |
3,000 |
2,000 |
| 3.E. |
Genetic Laboratory |
20,000 |
15,000 |
| 3.F. |
Any other Pathology laboratory |
30,000 |
20,000 |
| 4. |
Diagnostic Imaging service |
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| 4.A. |
X-Ray lab (Conventional) |
10,000 |
7,000 |
| 4.B. |
X-Ray lab (Digital) |
15,000 |
10,000 |
| 4.C. |
Mamography lab |
10,000 |
7,000 |
| 4.D. |
Bone Densitometry lab |
10,000 |
7,000 |
| 4.F. |
Ultrasonography lab |
10,000 |
7,000 |
| 4.G. |
Colour Doppler Imaging lab |
10,000 |
7,000 |
| 4.H. |
CT Scan lab |
20,000 |
15,000 |
| 4.J. |
Magnetic Resonance Imaging (MRI) lab |
30,000 |
20,000 |
| 4.K. |
Positron Emission Tomography (PET) Scan lab |
35,000 |
30,000 |
| 4.L. |
Echo-cardiography lab |
10,000 |
7,000 |
| 4.M. |
Electro-cardiography lab |
5,000 |
3,000 |
| 4.N. |
Electro-encephalography lab |
10,000 |
7,000 |
| 4.P. |
Electromyography lab |
10,000 |
7,000 |
| 4.Q. |
Audiometry lab |
5,000 |
3,000 |
| 4.R. |
Other Clinical Physiology |
10,000 |
7,000 |
| 4.S. |
Angiography |
25,000 |
20,000 |
| 5. |
Ayurvedic/Homeopathy/Unani/Acupuncture with recognizedqualification.
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5,000 |
3,000 |
