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EXTRAORDINARY

No. 2

GOVERNMENT OF GOA

Department of Public Health

___

Notification

47/5/2011-I/PHD/Part/(Vol.I)/1536

In exercise of the powers conferred by sub section (1) and (2) of section 47 of the Goa Clinical

Establishments (Registration and Regulation) Act, 2019 (Goa Act 19 of 2019), the Government

of Goa hereby makes the following rules, namely:—

1. Short title and commencement.— (1) These rules may be called the Goa Clinical

Establishments (Registration and Regulation) Rules, 2021.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. Definition.— (A) In these rules, unless the context otherwise requires,—

(1) “Act” means the Goa Clinical Establishment (Registration and Regulation) Act, 2019

(Goa Act 19 of 2019);

(2) “Ambulance” means any privately or publicly owned motor vehicle or vessel or aircraft

that is especially designed, constructed or modified, and equipped and is intended to be

used and is maintained or operated for the overland, water or air transportation of patients

upon the streets, roads, highways, waterways, river, airspace, or public ways in this state, or

any other motor vehicles, vessels or aircraft used for such purposes;

(3) “Appendix” means Appendix appended hereto;

(4) “Applicant” means a person who has made an application;

(5) “Building” includes—

SERIES I No. 15

Panaji, 8th July, 2021 (Asadha 17, 1943)

Reg. No. RNP/GOA/32/2021-23

RNI No. GOAENG/2002/6410

___________________________________________________________________________________________

Suggestions are welcomed on e-mail: [email protected]

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(a) a house, out-house, stable, latrine, godown, shed, hut, wall (other than a boundary

wall not exceeding two meters in height) and any other such structure, whether of

masonry, bricks, wood, mud, metal or any other material whatsoever;

(b) a structure on wheels or simplify resting on the ground without foundations; and

(c) a ship, vessel, boat (when outside the port limit of major ports as defined under

the Indian Ports Act, 1908 (Central Act No. 15 of 1908), Aircraft, and

(d) tent, van and any other structure used for human habitation, but do not include a

temporary shed erected on ceremonial or festival occasions.

(6) “care” means measures taken by a care provider or that are taken in a healthcare

establishment in order to determine a service recipient’s state of health or to restore or

maintain it;

(7) “categorization” is the process in which ideas and objects are recognized,

differentiated, and understood.

(8) “Classification” means the action or process of classifying something according to

shared qualities or characteristics.

(9) “Clinics” means— a medical facility run by a single or group of physicians or health

practitioners smaller than a hospital. Clinics generally provide only outpatient services and

can have an observation bed for short stay.

(10) “Collection Centre” means a Pathology Laboratory, other than Genetic laboratory

providing services regarding collection of samples or specimen for the purpose of

pathological, bacteriological, chemical, biological or other tests, examination, or analysis.

(11) “Consultant” Registered Medical Practitioner in different fields of medicine having

specialized knowledge, skill, expertise or experience who can act as specialist to provide

expert medical care and services to the patients.

(12) “Day care centre” means clinical establishment where persons to whom treatment of

that kind/those kinds is provided are reasonably expected to be admitted and discharged on

the same date;

(13) “Dental clinics”- are places where dentists provide dental care with no inpatient

facilities.

(14) “Dental hospitals”- are places where dentists provide outpatient dental care with

inpatient facilities

(15) “Department” means department of health/health Speciality or any other Government

department

(16) “Diagnostic Centre” means-stand-alone organized facilities to provide simple to

critical diagnostic procedures such as radiological investigation supervised by a radiologist

and clinical laboratory services by laboratory specialist usually performed through referrals

from physicians and other health care facilities.

(17) “Director” means Director of Health Services, Goa.

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(18) “Disaster” and “Disaster Management” shall have the meaning assigned to them

under the Disaster Management Act, 2005 (Act 53 of 2005).

(19) “Display” 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 media, elect

otherwise; or

(c) contained in any medium for communication produced or for use by an institution.

(20) “Emergency medical condition” means a medical condition manifesting itself by acute

symptoms of sufficient severity (including severe pain) of such a nature that the absence of

immediate medical attention could reasonably be expected to result in (i) death of the person

or; (ii) serious jeopardy in the health of the person (or in case of pregnant woman, in her

health or health of the unborn child); (iii) serious impairment to bodily functions; or (iv)

serious dysfunction of any organ or part of a body;

(21) “Emergency medical service” means the organization responding to a perceived

individual need for immediate medical care in order to prevent loss of life or aggravation of

physiological or psychological illness or injury;

(22) “emergency medical treatment” means’ the action that is required to be taken after

screening a person who is in an emergency medical condition, as to the stabilization of the

person and rendering of such further treatment as may be necessary for the purpose of

preventing aggravation of the medical condition of the person or his death;

(23) “Employee” means a person wholly or principally employed in, or in connection with,

a clinical establishment, whether working on permanent, periodical, contractual or piece-rate

wages or on commission basis even though he receives no reward or payment for his labour.

(24) “Form” means the form appended hereto;

(25) “General Hospital” is a set up having facilities, medical staff and all necessary

personnel to provide diagnosis, care and treatment of a wide range of acute conditions,

including injuries, and normally has an emergency department to deal with immediate and

urgent threats to health;

(26) “Genetic laboratory” means a laboratory as defined under the Pre-conception and

Pre-natal Diagnostic Techniques (Prohibition of sex selection) Act, 1994 (Central Act 57 of

1994).

(27) “Healthcare establishments” means any clinical establishment run by private or

public sector agencies;

(28) “Hospital” means health care institutions that have an organized medical and other

professional staff, and inpatient facilities, and deliver medical, nursing and related services

24 hours per day, 7 days per week, which offer a varying range of acute, convalescent and

terminal care using diagnostic and curative services in response to acute and chronic

conditions arising from diseases as well as injuries and genetic anomalies;

(29) ‘Hospital bed’ means a bed that is regularly maintained and staffed for the

accommodation and full-time care of inpatients and is situated inwards or a part of the

hospital where continuous medical care for inpatients is provided;

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(30) “Imaging centre” means any establishment or premises used or intended to be used

in production of images or visual display of structural or functional patterns of organs or

tissues with the aid of any kind of electro-magnetic or sound wave for the purpose of

diagnosis, treatment or research of diseases;

(31) “Indigent person” means a person who has no visible means of income or whose

income is insufficient for the subsistence of his family and shall include,—

(i) a person who has received a ration card in the category of Below Poverty Line (BPL);

and

(ii) a person not included in sub-clause (i) but has been identified as an

indigent person by such designated authority as may be notified;

(32) “Informed consent” means consent given to a proposed specific intervention, without

any force, undue influence, fraud, threat, mistake or misrepresentation, and obtained after

disclosing to the person giving consent adequate information including risks and benefits of,

and alternatives to the proposed intervention in a language and manner understood by such

person with no binding to consent after being informed;

(33) “Inpatients”– residents hospitalized for indoor care across all types of hospital beds;

(34) “Inpatient facilities” means any establishment having beds for admission of patients;

(35) “Isolation” means the physical separation and confinement of an individual or groups

of individuals who are infected or reasonably believed to be infected with a contagious or

possibly contagious disease from non-isolated individuals, to prevent or limit the

transmission of the disease to non-isolated individuals;

(36) “Large Laboratory” means as a Pathology Laboratory, other than Genetic laboratory

performing all the Microbiology, and Morphological Pathology tests in addition to tests

performed by the medium laboratory;

(37) “Local authority” means,—

(a) in any municipal area, the Corporation, or Municipal Council concerned;

(b) in notified area, the Notified Authority;

(c) in any other area, the Village Panchayat concerned.

(38) “Maternity Home”– means any premises used or intended to be used for reception of

pregnant women or of women in labour or immediately after childbirth;

(39) “Medical device” means any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other similar or related article.

(40) “Medical Diagnostic laboratory” means a laboratory with one or more of the following

where microbiological, serological, chemical, haematological, immune-hematological,

immunological, toxicological, cytogenetic, exfoliative cytogenetic, histological, pathological

or other examinations are performed of materials/fluids derived from the human body for the

purpose of providing information on diagnosis, prognosis, prevention, or treatment of

disease;

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(41) “Medically Necessary” means a service or procedure that is scientific, appropriate and

consistent with diagnosis and which, using accepted standard treatment protocol, standard

operating procedures or any other standards of medical practice, could not be omitted

without adversely affecting the patient’s conditions;

(42) “Medical Record” means any paper, film, print out, slide, solution or medium, or any

documentation of services performed at the direction of a service provider which can be

deciphered or used to indicate and diagnose condition of the human body or a part of it or

any material taken out of it and the course of treatment including nursing care administered

to, or undergone by, the person;

(43) “Medical Superintendent” means a person by whatever name and designation he/she

is called, who is a medical practitioner and is in charge of, or is entrusted with the running

of, a clinic, hospital or nursing home;

(44) “Medical supplies” refers to the non-durable disposable health care materials ordered

or prescribed by a physician, which is primarily and customarily used to serve

a medical purpose and includes osteotomy supplies, catheters, oxygen, and diabetic

supplies;

(45) “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;

(46) “Medium Laboratory” means a Pathology Laboratory, other than Genetic laboratory

performing all the clinical pathology and haematology tests in addition to tests performed by

the small laboratory but excluding Microbiology, and Morphological Pathology test;

(47) “Multi-specialty hospitals” are – hospitals offering specialized and tertiary care in

single or multiple facilities segregated units each of which are devoted to a complexity of

patient care defined in this sub-section;

(48) “Near relative” means any of the following relatives of the deceased (or patient)

namely, a wife, husband, parent, son, daughter, brother and sister and includes any other

person who is related to the deceased or any other person as may be defined under Indian

Succession Act, 1925 [Act XXXIX of 1925];

(49) “Norm” means a statistical normative rate of provision or measurable target outcome

over à specified period of time;

(50) “Nursing Home” means any premises used or intended to be used for reception of

persons suffering from any sickness, injury or infirmity and providing of treatment and

nursing for them and include a maternity home;

(51) “Outpatients” where care is provided without admission/hospitalization as inpatient;

(52) “Package of service” or “package” means a group of health care related services with

clear item wise explanation wrapped under a fixed price to be provided to the service

recipient;

(53) “Paramedical Professional” means any Technician like ECG Technician, Medical

Laboratory Technician or Ophthalmic Assistant and includes such other technicians or any

personnel, who helps in providing health care services, teaching or practice of medicine by a

registered medical practitioner;

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(54) “Patient” means a service recipient who has received any kind of service or care from

any Clinical establishment with or without being registered by the patient registration

system of that Clinical Establishment and shall include any child born to a patient and is

entitled to enjoy all the rights, responsibilities and obligation of being a patient;

(55) “Patient Party” means a person willing to enjoy all the rights, responsibilities and

obligation conferred upon a patient and is recognized as such by the clinical establishment

or the service provider and includes,—

(i) a adult member of the family or near relatives; or

(ii) guardian of the service recipient, in case of service recipient being a minor; or

(iii) one of the friends, colleagues or any person authorized by the service recipient as

his representative; or

(iv) guardian, legal heir or natural successor or near relatives of the service recipient in

event of the death of the service recipient or his being incapacitated due to existing

physical/mental/emotional state rendering him incapable to authorize a person as his

Representative.

(56) “Personal care” means care which can be provided by a non-professional and shall

include but not limited to-

(i) assistance with one or more of the following activities namely bathing, showering or

personal hygiene; toileting; dressing or undressing; eating meals; or

(ii) assistance for persons with mobility problems; or

(iii) assistance for persons who are mobile but require some form of supervision or

assistance; or

(iv) the provision of substantial emotional support; or

(v) assistance for summoning up on-duty nurse or medical officer; or

(vi) any such reasonable assistance expected of him subject to his skill, competency and

experience;

(57) “Polyclinic” means a medical clinic where the proprietor and the service provider may

be same or different persons;

(58) “Premises” means any building, structure or tent together with the land on which it is

situated and the adjoining land used in connection with it and includes any land without any

building, structure or tent and any vehicle, conveyance, vessels or aircraft;

(59) “Primary Consultant” means a Registered Medical Practitioner as defined;

(60) “Proprietor of clinical establishment” means a person who has been granted a license

under the Act;

(61) “Public Health Emergency” means an occurrence or imminent threat, including owing

to degraded environmental conditions, of an illness or health condition that:

(a) Poses a high probability of any of the following harms:

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(i) a large number of deaths or illness in the affected population;

(ii) a large number of serious or long-term disabilities in the affected population,

including teratogenic effects, or;

(iii) widespread exposure to an infectious or toxic agent that poses a significant risk

of substantial future harm to a large number of people in the affected population;

(b) And can be caused by any of the following:

(i) the appearance of a novel or previously controlled or eradicated infectious agent or

biological toxin, or;

(ii) any disaster, including major accidents.

Explanation:— Public health emergency can be due to communicable infectious diseases;

chronic non-infectious, non-communicable conditions affecting large population, notified

diseases, and conditions of public health importance or locally endemic diseases.

(62) “Quality assurance” means any planned and systematic action necessary to provide

adequate confidence that a structure, system, component or procedure will perform

satisfactorily, in compliance with quality control standards specified by the competent

authority, and includes safety standards;

(63) “Quality control” means the set of operations (programming, coordinating,

implementing) intended to maintain or to improve quality and includes monitoring,

evaluation and maintenance at required levels of performance;

(64) “Qualified technician” means any paramedical professional who possesses a degree,

diploma or certificate in any paramedical course of at least two years or equivalent, granted

by any University established by law or any other institution recognized by the Department

in this behalf.

(65) “Records” includes invoices, receipts, orders for the payment of money, bills of

exchange, cheques, vouchers and other documents of prime entry and also includes such

working papers and other documents as are necessary to explain the methods of calculations

by which accounts are made up;

(66) “Reference laboratory” means a laboratory, registered under the law or accredited by

National Accreditation Board for Testing and Calibration Laboratories or organization of

similar repute, which accepts sample or Specimen from other clinical establishments for

testing and examination;

(67) “Rehabilitation” means a goal-orientated and time-limited process aimed at enabling

impaired persons to reach an optimum mental, physical or social functional level;

(68) “Resident Medical Officer” or “RMO” means the Duty Medical Officer;

(69) “Scientific” means anything that has been substantiated and proved on the protocol of

evidence-based medicine;

(70) “Section” means a section of the Goa Clinical Establishment (Registration and

Regulation) Act, 2019;

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(71) “Service” means health care related services and non-health care related services

including but not limited to ambulance service therapeutic service, diagnostic services,

in/out patient & emergency services, dietary services, palliative services, and rehabilitative

services;

(72) “Small Laboratory” means a Pathology Laboratory, other than Genetic laboratory

performing only the Routine Clinical Pathology and Haematology tests e.g. Hb, TC, DC, ESR,

BT, CT, PT, Routine examination of stool, urine, sugar (blood and urine), urea, and

cholesterol;

(73) “Solo clinic” means a medical clinic used for consultation and treatment by a single

doctor where the proprietor and the service provider is the same person;

Explanation: Single Doctor shall include any registered medical practitioner other than a

dental practitioner.

(74) “Sonologist” means a qualified registered medical practitioner as defined under the

Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of sex selection) Act, 1994

(Central Act 57 of 1994);

(75) “Specialty Hospital” are - hospitals having facilities, medical staff and all necessary

personnel to provide diagnosis, tertiary care and treatment of a limited specialized group of

acute or chronic conditions such as psychiatric problems, certain disease categories such as

cardiac, oncology, or orthopaedic problems, and so forth;

(76) “Staff” means a service provider or other categories of employees or any other person

who provides any service within the premises of the healthcare institution, whose services

are utilized in the clinical establishment for providing any kind of service includes those

working on part-time, temporary contractual, consultancy, honorary or on any other basis

whether on payment basis or not;

(77) “Statutory FORM” means a form appended to these Rules;

(78) “Summary Medical Report” means a report to be provided by the Primary Medical

Attendant containing such particulars which includes but not limited to–

(i) the reasons for admission, significant clinical findings, provisional diagnosis and

results of investigations, treatment and the nature of the health service rendered; and

(ii) the final diagnosis and condition of the patient at the time of discharge;

(iii) follow-up advice, medication and other instructions and when and how to obtain

urgent care when needed in an easily understandable manner; and

(iv) any other particulars which shall be useful for future health care of the patient.

The summary of Medical Records to be made available to the patient party at the time of

Death to be known as Summary Medical Report (Death) and shall contain the following

additional particulars:

(i) The terminal care given; and

(ii) a copy of death certificate issued as per Medical certification of Cause of Death

guideline provided under the Birth and Death Registration Act, 1969 [Act No. 18 of 1969].

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(79) “Table’’ means a table appended to these rules

(80) “Telemedicine” means the practice of medicine using audio, visual and data

communications;

(81) “test” or “examination” means a medical test or procedure performed to detect,

diagnose or monitor disease, disease processes, susceptibility or to determine a course of

treatment;

(82) “Trade license”: means a certificate of enlistment by whatsoever name called issued

by the authority of the local self-government like Municipality or Panchayat;

(83) “treatment” means administration of any one or combination of therapies under any

recognized system of medicine by a Registered Medical Practitioner to a person for restoring

or maintaining his health;

(84) “University” means a University defined under clause (f) of section 2 of the University

Grants Commission Act, 1956 (No. 30 of 1956) and includes an institution declared to be a

deemed University under section 3 of the said Act;

(85) “Unwarranted public exposure” means a situation where the patient is subjected to

exposure, private or public, either by photography, publication, videotaping, discussion, TV

broadcasting or radio broadcasting, or by any other means that would otherwise tend to

reveal his person or identity and circumstances under which he has or will be under medical

or surgical treatment without his consent;

(B) The words and expressions used and not defined in these rules, but defined in the Act,

shall have the same meaning respectively assigned to them in the Act.

3. Allowance Payable to the members of the Council.— The members of the Council other

than ex-officio members shall be paid an allowance of Rs. 800/- for each sitting.

4. Minimum standards of Facilities and Services.— Every Clinical Establishment shall fulfil

following minimum standards of facilities as specified in Tables hereto:

TABLE I

(See Rule 4)

Standards to be maintained by doctor/medical practitioner practicing in Medicine/Dentistry

in a clinical establishment

I) Staff

(1) The Medical Practitioner shall be assisted by para-medical staff, including qualified

and/ or experienced Nurse/s and Technician/s (wherever required), with Attendants/

Servants, etc.

(2) They should be free from communicable or contagious diseases and medically

examined at the time of appointment and thereafter every year.

(3) They should wear clean identifiable uniforms.

(II) Facilities:— The premises should include-

(1) A Consulting Room;

(2) A Patient Room/s in case of inpatient facility;

(3) A Reception/Lobby area;

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(4) Equipment’s and Instruments of good quality and in adequate quantity to carry out the

various required tasks;

(5) Beds with mattresses and linen;

(6) Adequate number of toilets with water facility;

(7) Fully equipped Operation Theatre and Labour Room for hospitals as per speciality;

Explanation: list of essential drugs for each specialty may be laid down from time to time

and each clinical establishment is expected to have all these drugs in store in addition to

general list of essential drugs at any given point in time.

(8) Well equipped casualty room for hospitals.

(9) Proper method of disposal of Bio-Medical Waste as per the Bio-Medical Waste

(Management) Rules, 2016, as amended from time to time.

(III) In case of Hospital/Nursing Home/Diagnostic Centre/Pathological Laboratory, names,

contact number and license numbers of all the practicing doctors/medical practitioners

including that of honorary doctors shall be displayed at conspicuous place.

(IV) Minimum standards as laid down under trade license issued by the Municipal

Corporation/Municipal Council/Village Panchayat concerned shall be maintained.

(V) In addition to above, proper hygiene and cleanliness, adequate water and power supply

quality equipment/instruments, beds with mattresses and linen, shall be provided and always

maintained neat and clean.

TABLE II

Standards for Service Provider

Part I: General

1. Introduction

1.1. The clinical establishment should maintain the Service Provider standards and norms as

specified herein or any such standards and norms as may be notified from time to time.

1.2. The staff can be classified into the following categories: (a) Medical Staff; (b) Nursing

staff; (c) Paramedical-Technical Staff; (d) General Duty attendant and other Gr-D staff;

(e) Administrative-Managerial staff; (f) Non-medical technical staff; (g) Other staff.

1.3. Unless 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.

1.4. Any kind of trainee Medical/Nursing/paramedical staff should not be included while

considering the manpower.

2. Medical Staff

2.1. In case of specialized service, it should have at least registered medical practitioner of

modern medicine having minimum qualification of a post-graduate diploma/degree in relevant

discipline to supervise/perform/conduct the test/procedure, to interpret and give the result or

to examine and advice.

2.2. There should be one registered medical practitioner available on duty at each

consultation room of the OPD clinic during the OPD hours to ensure the availability of services

as described in the mandatory display by the clinical establishment.

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2.3. IPD facilities should have two kinds of Medical staff or doctors: (a) Consultants and

(b) Duty medical officers. As soon as a patient arrives at a clinical establishment he or she

should immediately be attended by a Duty Medical Officer. A consultant should see the patient

as soon as possible.

2.4. If it is medically necessary, the Duty Medical officer may refer the patient to the suitable

speciality consultant who should be asked to render his opinion or advice or to perform a

particular procedure in his capacity of being a Consultant having specialized knowledge, skill,

expertise or experience. Any kind of trainee Doctor should not be considered as the service-

provider for the purpose of the Act or rules.

2.5. There should be at least one Duty medical officer to act as RMO, in case of a

Maternity/nursing home, available on duty round the clock.

2.6. In case of inpatient based facilities with more than 30 beds one duty medical officer

should be available on duty round the clock.

2.7. In addition to the duty Medical officer, the number of consultants required in the

Inpatient based Facilities should depend upon type of the services being provided (general

/specialty/super-speciality etc.) there.

eg. A nursing home providing medical facilities should have a physician available on call

round the clock. A nursing home providing surgical facilities should have a surgeon and

anaesthetist available on call. In case Emergency Surgical Facilities are also provided then a

surgeon and anaesthetist should be available on call round the clock.

eg. The resuscitation of new born should be under the supervision of a trained Registered

Medical Practitioner preferably a paediatrician. Maternity home should have gynaecologist

/surgeon, anaesthetist, and paediatrician.

3. Nursing staff:

Nurses— Diploma/degree in nursing/midwifery from any recognised institution and

registered with the Goa Nursing Council. 70% of the nurses should possess the above

mentioned qualification and 30% should be trained staff having minimum 10^th standard pass

and having experience of working in hospital for 02 years.

4. Paramedical— Technical Staff:

Depending upon the nature of service offered by the clinical establishment and the expected

workload, at least one on duty qualified technical staff should be engaged.

In case of old establishment, the technical personnel who are found to be under qualified

may continue to work in the same capacity but for further recruitment, properly qualified

personnel are to be engaged. No paramedic should run the establishment without the

supervision of a registered medical/Dental practitioner.

5. Attendant:

Minimum 6^th class, shall have working knowledge of sepsis/asepsis and should be able to

read English and read/write Konkani/Marathi.

6. Administrative – Managerial staff

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

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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 as per advise of the Authority.

7. Non-Medical Technical Staff:

Depending upon the type of facilities being offered, extent of outsourcing etc. Support staff

like Dietician, Cook, Plumber, Electrician, telephone operator, Central heating/AC operators 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 Duty Medical Officers exclusively for intensive care having post graduate diploma or

degree or adequate working experience at a recognized hospital in the concerned discipline.

1.2 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 recognised hospital in the concerned discipline.

1.3 There 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 around 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 Anaesthetist should be available as and when required.

3. Pathology Laboratory Facilities:

3.1 Every Small Laboratory should have at least one registered medical practitioner of

modern medicine having minimum qualification of a DCP or DTM&H or equivalent post-

graduate or a MBBS degree with at least five years’ experience in laboratory medicine to

supervise the Laboratory work, to interpret and give the result. It should have one duly

qualified medical technician on duty having minimum qualification in medical laboratory

technology or equivalent.

3.2 Every Medium Laboratory should have (a) at least one registered medical practitioner as

mentioned under the small laboratory and in addition to that, (b) one qualified person having a

minimum qualification of a MSc (Biochemistry/Medical Micro-biology) or MD (Biochemistry) or

equivalent post-graduate degree who can supervise those test. It should have two on duty

qualified medical technicians.

3.3 Every large laboratory should have (a) at last one registered medical practitioner having

minimum qualification of a MD (Pathology) or equivalent post-graduate degree; and (b) at least

on registered medical practitioner having minimum qualification of a MD (Microbiology) or

equivalent post-graduate degree; and (c) at least on registered medical practitioner having

minimum qualification of a MD(Biochemistry) or equivalent post-graduate degree to supervise

the Laboratory work, to interpret and give the result. It should have three on duty qualified

medical technicians.

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3.4 The histopathological, cytopathological and special haematological tests should be

carried out personally by a MD (Pathology) or equivalent. Multi-disciplinary laboratories should

identify a group leader, with specific qualification for each.

Explanation: A qualified person having Ph.D in the respective discipline should be

considered as equivalent.

3.5 A collection centre should be under supervision of a Registered Medical Practitioner of

modern medicine. The collection centre should have one– on duty qualified medical technician

or support staff having higher secondary (with bioscience) certificate with a minimum five year

experience in an established medium sized laboratory.

TABLE III

Standards for Equipment, Medical Devices, Medical Supplies

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.

1.2. The clinical establishment should follow the IPHS guidelines regarding equipment and

medical supplies for that category of establishment and Guidelines for Good Clinical Laboratory

Practices by Indian Council of Medical Research.

1.3. The 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.

1.4. All 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.

1.6. New 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 and records of such calibration maintained for inspection by the

authorities

1.7. Under no circumstances should the completion of necessary equipment servicing or

calibration be delayed or cancelled in order to accommodate further service provision.

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) Three cylinders for each 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

flowmeters 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.

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2.2. If 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 each Delivery room/Recovery room/Emergency area/ward; (b)

vacuum outlet should be provided.

2.3. Nitrous oxide outlet should be provided as per the following norms: One outlet per table

for each Operating theatre.

2.4. In all these areas one O2 cylinder should be kept as spare. These 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: Specific

1. Examination Treatment Dressing room

1.1. Each Examination Room should be provided with equipment like: Chair for consultants

(One for each consulting room); Chairs for patient and persons accompanying patient (Two or

three per consulting room and casualty); Revolving stool (metallic - One for each consulting

room); Doctor’s table (One for each consulting room); Examination table with safe footsteps,

mattress and pillow (One for each consulting rooms); Examination table for OBG clinic (with

appropriate light fixture and stool for doctor); X-ray viewing box; Bowls; Wash basin with liquid

soap dispenser and towel rail (One in each consulting room and in casualty), Weighing

machine; Screens for every examination table.

1.2. Each Examination Room should be provided with instruments and medical supplies for

patient examination like (torch, tongue depressor, stethoscope, Blood Pressure Apparatus,

Thermometer, Kidney trays, Proctoscope (small medium and large for surgical OPD), Hammer

(for eliciting tendon jerks), Tuning fork, Ant. vag wall retractor For OBG/OPD; Bivalved

speculum, Sims speculum sterilizer (preferable); Gloves; Disposable Syringes, Gloves and

Masks; Towels, Bedsheets post exposure Prophylactic kit, First Aid equipment’s, emergency

Drugs.

1.3. Treatment/Dressing room and Injection room should be provided with Equipment &

Furniture like: (1) IV stands; (2) Examination table with mattress to carry out dressings

(3) Dressing trolley; (4) Ambus bag; (5) Suction apparatus; (6) Oxygen cylinder with flowmeter;

(7) One trolley for oxygen cylinder; (8) Laryngoscope with blades; (9) Dustbins with lids etc.

1.4. Treatment/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 ccs needles curved, cutting and round bodied small and

medium sizes etc.

1.5. Emergency trolley tray should be provided with: Inj adrenaline,; Inj. soda bicarb; Inj

aminophylline; chlorpheniramine; Inj calcium gluconate; Inj Frusemide; Inj vesopressor; Inj. 25%

glucose I.V. fluids etc.

1.6. Catheters 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

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1.7. Venesection tray should be provided with: Small plain forceps and small toothed forceps;

Venesection scissors; Curved cutting needles medium sizes; Small mosquito forceps; Towels;

One bowl; Lubricating jelly;

2. IPD facilities

2.1. The number and type of such Equipment’s 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 & quality of equipment and medical supplies like (a) equipment for emergency

(b) equipment for ward (c) Trolley & Stretcher; (d) Hospital furniture; (e) Linen etc.

2.2. Each nursing Home should be provided with such equipment’s for emergency like

suction machine with generator connection & standby foot suction machine; all instruments

/equipment’s required for emergency & Basic life support (CPR); Emergency Tray; ECG

Machine; Dressing trolley; Resuscitation tray.

2.3. In case of nursing home with more than 30 beds, each nursing station should be

provided such equipment and medical supplies like: (1) Desk/counter; (2) Wall clock; (3) Wash

basin with liquid soap dispenser and towel rail; (4) Sink unit; (5) Notice boards; (6) Fire fighting

equipment; (7) Enema can-set (One per ten beds); (8) Vohler-Braun splint (for limb elevation);

(9) Ophthalmoscope; (10) Torch (One large size -3 batteries & one small size -pin-point source);

(11) Percussion hammer; (12) Laryngoscope with blades of all sizes; (13) Medicine trolley;

(14) X-ray viewing box for one X-ray plate; (15) Refrigerator 300 litres; (16) Weighing machine;

(17) Speculum & retractors; (18) Height scale (19) Stethoscope; (20) Glucometer; (21) Suture

removal sets; (22) Dressing sets; (23) Cutdown sets etc

2.4. Each nursing Home should be provided with such Trolley & Stretcher for each ward:

Minimum of two stretchers/trolleys and two wheel chairs should be provided. These

stretchers/trolleys/wheel chairs (should always be functional in noiseless condition).

2.5. Each nursing Home 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 (If provided with facility for IV sets, separate IV stands need not be provided); drip

stand; One dustbin with lid; Indoor papers stand/holder.

2.6. Each IPD facilities should be provided with Linen adequate scale. Sheet and cover

should be changed on daily basis. Fresh blankets and linen-set should be supplied at the time

of admission.

2.7. Each Ward store should be provided such equipment and medical supplies like

(1) Storage racks; (2) Oxygen cylinders; (3) IV stands; (4) Suction apparatus; (5) IV fluids and IV

sets; (6) Foley’s catheters with urine bags; (7) Naso-gastric tubes.

2.8. Each nursing home having Operation theatre should be provided with OT equipment’s

(1) Anaesthesia machine with complete accessories; (2) Multi Channel Monitor; (3) Pulse

Oxymeter; (4) Suction apparatus – Electric/Battery/Foot operated; (5) Fix Operating Room lights

with operation; (6) Bipolar Electro –Surgical Cautery; (7) Resuscitation Trolley; (8) Facilities for

Blood Transfusion; (9) Surgical operating instruments for type of surgery which is being

conducted in the Nursing Home; (10) High pressure autoclave with modern system of quick

sterilization of surgical sterilization instruments and operating linen and other items; etc. In

case of nursing home with more than 30 beds, each OT should be provided with Defibrillator

with automatic external defibrillator and Ventilator.

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2.9. Nursing station should be provided with Equipment & Furniture like: (1) Desk/counter;

(2) Chairs; (3) Notice boards; (4) Communicating system; (5) Storage space; cupboards, etc

3. Maternity Home

3.1. All Maternity home should have the following instruments & equipment required for

Emergency obstetric care: LSCS, Low mid cavity foreceps/kiellandforcep, Vacuum extractor

and suction machine); D&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 equipment’s

3.2. All Maternity home should have the following instruments & equipment Labour Room &

Newborn corner: Delivery sets; Labour table; Doppler Foetal monitor; suction machine with

generator connection & standby foot suction machine; Neonatal Resuscitation kit; oxygen

cylinder; one infant warmer; weighing machine for the babies.

4. ICU

4.1. 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.

4.2. It should be provided with adequate quantity & quality of equipment’s and oxygen

(preferably central oxygen or one oxygen cylinder per bed with two standby cylinders) etc. An

indicative List of Equipment (12 Bedded ICU 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 Manoeuvred 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.

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(11) Crash/Resuscitation trolley to hold all resuscitation equipment and Medicines (at the

rate of 2 for ICU and 1 for HDU;

(12) Pulse Oxometer (Small Units 2 as stand-by units);

(13) Refrigerator (1 per ICU) with freezer compartment;

(14) HD Machines (2 per ICU) 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 ICU)

(17) Intermittent Leg Compressing Machine to prevent DVT (2 per ICU);

(18) Airbeds to prevent Bed sores (1 per 2 beds);

(19) Intubating Video scope to make difficult intubations easy (1 per 1CU);

(20) Glucometer (2 for ICU, 1 for HDU);

(21) ICU Dedicated Ultrasound and Echo machine (1 per ICU) with recent advances to look

instantly even at odd hours. Vascular filling, central lines, etc,;

(22) Bedside X ray (1 per ICU);

(23) ETO sterilization to sterilize ICU disposables regularly (1 per ICU);

(24) Spinal Board for spine trauma patients (2 per ICU);

(25) Rigid Cervical Spine collars for stabilizing cervical spine (2 per ICU);

(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 ICU);

(30) Fibroptic Bronchoscope (1 per ICU)

(31) Computers with LAN, Internet facility and printer to be connected with all

departments

5. Nuclear Medicine Therapy Unit

5.1. There should be installation of “Type approved” PET-CT, SPECT-CT and GAMMA

CAMERA for medical diagnostic purposes (Certificate of “Type Approval” to be obtained from

AERB). Other equipment’s like Gamma Probe, Thyroid uptake system etc. need to be

purchased from approved vendor and to be AERB Draft The West Bengal Clinical

Establishment (Registration and Regulation) Rules, 2012 45 approved. For the supplied

isotopes, radiopharmaceuticals and blood products used in nuclear medicine from external

suppliers.

5.2. Equipment for sedation and monitoring of sedated patient should be available on site. If

intravenous sedation is performed there should be equipment for continuous pulseoxymetry.

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Equipment’s and drugs for the management of potential complication should be immediately

available. For paediatric patient, sedation monitoring equipment should be capable of

measuring saturating end tidal CO2 and non invasive blood pressure. There should be

equipment for endotracheal intubation of children in case of complication. If clinical exercise

stress testing is performed, there should be equipment available for it.

5.3. Where appropriate to the patient population and procedure performed, equipment for

general anaesthesia and monitoring of the patients should be available on site. Where

warranted there should be appropriate resuscitation equipment available. Facilities should be

available for cardio pulmonary resuscitation and basic life support appropriate to the level of

cardiac stress testing performed.

5.4. In addition all the equipment should be checked and calibrated specifically for the

following: (a) Dose calibration and constancy check; (b) Reproducibility and linearity checks of

the dose calibrator; (c) Geometric correction factor check; (d) Calibration of energy window

setting; (e) Check of signal uniformity, linearity, sensitivity and resolution; (f) Check of

geometric distortion and spatial resolution; (g) Check of collimator absolute and relative

sensitivity; (h) Centre of rotation check; (i) Pixel calibration; (j) SPECT phantom reconstruction

check; (k) Crystal energy resolution check; (l) Molybdenum breakthrough check; (m) Ambient

radiation dose management; (n) Radiopharmaceuticals sterility checks; (o) Film processor

checks.

6. Pathology Laboratory

6.1. Equipment performance should be verified from Internal Quality Control results and

External Quality Assessment results. 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

6.2. In case of large laboratory, all analytical equipment should be calibrated and calibration

certificate provided by equipment company. Non-analytical equipment such as pipette,

thermometer, weighing balance and centrifuge should be calibrated by accredited calibration

laboratory or done in house.

6.3. The pathology laboratory should be provided with the Furniture & Fixtures as per norms:

6.4. Standard 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. to be used for in house procedures should be defined in SOP. Those reagents

are to be recorded in stock register.

6.5. Quality 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.

6.6.

Reagent

label

should

contain

name

of

reagent,

concentration,

date

of

preparation/opening, date of expiry, storage conditions and warnings eg. ‘do not use if solution

is turbid’ where applicable. When individual bottles are small, this information can be recorded

in a goods received ledger.

6.7. Microbiology 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

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against reference strains. Laboratories testing microbiology specimens should check the

quality of media by using appropriate reference strain and pH of the media.

6.8. All batches of culture containers should be checked for sterility before issuing to

patients for collection of specimen.

6.9. Water 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.

6.10. Depending upon the services available, the small, medium or large laboratory should

be provided with (a) General equipment’s for lab; (b) Equipment’s for Clinical Pathology; (c)

Equipment’s for Histopathology; (d) Equipment’s for Microbiology; (e) Equipment’s for

Haematology; (f) Equipment’s for Biochemistry; (g) Equipment’s for Serology.

6.11. General 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, slid trays, test tube stands, stop watch etc

6.12. Equipment for Clinical Pathology: Binocular Microscopes; Auto-analyzer/multi-

functional for haematology 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.

6.13. Equipment 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 & 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 eg. knife, scissors, foreceps, blades etc; weighing machine (electronic preferred);

Disposables gloves, masks and white coats; Kits for immunohisto chemistry and other

necessary equipment; Stains and other reagents.

6.14. Equipment for Microbiology: Various media for culture and sensitivity; Swab sticks,

transport media, universal containers, blood culture bottles; Antibiotics disks; Biological safety

cabin II; Discard jars and disinfectants; Loops, wires, spirit lamps etc.

6.15. Equipment for Haematology: Microscope; Cell Chamber; Cell Counter (Preferable);

Haemocytometer; Haemometer, etc.

6.16 Equipment for Biochemistry: Centrifuge; Colorimeter/Semi-autoanalyzer; Refrigerator;

Micropipettes; Water bath etc.

6.17. Equipment’s for Serology: Centrifuge; Refrigerator; Water bath; Incubator etc.

7. X-Ray lab

7.1. 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.

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7.2. 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 lab 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.

7.3. The lab 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. An automatic film

processor is desirable.

7.4. X-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 should for Dark room. There should be appropriate resuscitation equipment and drugs

available on site for management of contrast reactions.

7.5. All the equipment’s 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.

7.6. In 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.

8. Mammography Lab

8.1. There should be dedicated mammographic equipment with a grid and appropriate

compression device. Mammographic biopsy attachment is desirable.

8.2. In 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) Artefact

evaluation; (f) Breast compression deice check; (g) Screen cleanliness check.

9. Ultrasonography

9.1. The equipment should be registered under the PC-PNDT act as per rules and the

certificate should be displayed. 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.

9.2. In addition all the equipment should be checked and calibrated specifically for the

following: (a) Calibration of calipers; (b) Calibration of power output

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10. Bone mineral densitometry

10.1. 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.

10.2. In 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.

11. MRI

11.1. 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.

11.2. In 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.

11.3. The equipment should be registered under the PC-PNDT act as per rules and the

certificate should be displayed. Registration of clinic is mandatory along with details of

machine and radiologist/sonologist. Signages in local & English language should be displayed,

indicating that “Sex determination is not done here. It is a punishable offence”.

12. CT scan

12.1. Whole body CT Scan with scan cycle less than I sec (sub second). Installation of all

equipment’s should be approved by AERB. Basic life support and resuscitation equipment and

drugs should be available on site.

12.2. The 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).

12.3. In 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 10 yrs.

old.

13. Interventional radiology

13.1. 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.

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13.2. Mobile 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.

13.3. There should be facilities for patient monitoring by ECG/BP monitoring/pulse oxymetry

/monitoring of direct pressure gradients as required by the scope of services listed.

13.4. The 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).

13.5. There should be adequate protective measures as per AERB guideline.

TABLE IV

Standards for Water, Sanitation, Hygiene, Safety and Security

Part I: General

Introduction

The clinical establishment should maintain the Water, Sanitation, Hygiene Safety & Security

standards and norms as specified in this schedule or any such standards and norms as may be

notified from time to time.

1. Location and surroundings

1.1 The clinical establishment should be situated in a site having clean & 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.

1.2 The 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.

1.3 No clinical establishment shall be allowed to function from an unsafe building.

2. Health, Clothing and Sanitary Requirements of staff

The staff employed should be free from contagious disease and should be provided with

clean uniforms suitable to the nature of their duties. The workers should be medically examined

at the time of employment and periodically so examined thereafter. There should be facilities

for medical checkup of hospital staff of all categories particularly cooks and staffs of the dietary

department.

3. Sanitation & Hygiene

All the rooms/wards should be properly ventilated and have adequate lighting facilities.

There should be adequate Sewage Disposal arrangement.

4. General Water Supply:

4.1 Arrangement should be made to supply adequate quantity and quality of water. The

inpatient facilities with more than 30 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.

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4.2 The 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.

4.3 Storage capacity for minimum 48 hours requirement should be made on the basis of

above consumption. Arrangement should be provided to ensure uninterrupted water supply for

operation theatre.

4.4 In case of inpatient facilities with more than 30 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.

5. Signage

The clinical establishment should have: (a) properly displayed safety signs, for example, (a)

signs of identification of safety equipment’s such as fire extinguishers, (b) signs to identify

hazards and hazardous activities, (c) signs to delineate public areas from area of restricted

access.; etc.;

6. Standard Fire safety measures

It should be provided as per The Goa Fire Safety Act/Rules and guidelines issued by that

department.

7. Standard Biosafety Measures

7.1. Entry into Laboratory/work area should be restricted. Staff should be attired with proper

suitable clothing for working in the laboratory. Work surfaces should be disinfected when

procedures are completed and at the end of each working day.

7.2 Gloves should be worn for all handling of infectious material. Examination gloves of vinyl

or latex should be used in laboratory, ward, and 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.

In 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.

All 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. Safety measures against Disaster

It should be provided as per IPHS guideline.

Part II. Specific

A. Radiation safety

Rooms housing diagnostic Xray 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 pediatric wards and other departments of the hospital. The X-Ray lab should

take due safeguards against the radiation protection and should adhere to prescribed

regulations of AERB which are amended from time to time.

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B. 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.

C. Biosafety Measures in clinical lab

(i) The lab should ensure Safety in laboratories therefore includes protection of both the

staff and the environment from hazardous materials because (a) the Personnel working in

laboratories is at risk from various chemicals, infectious materials, fire hazard, gas leak etc.

and (b) The environment is also at risk of being contaminated by hazardous materials used

and wastes generated in the laboratory.

(ii) Regarding biosafety, the labs should follow the Four levels of biosafety laboratories

(BSL) developed by World Health Organization (WHO).

(iii) Goa State Pollution Control Board authorisation shall be mandatory.

(iv) Bio Medical Waste shall be disposed off as per the Bio Medical Waste Management

Rules, 2016.

5. Minimum requirement of personnel shall be as follows:

Every Clinical Establishment shall fulfil following minimum requirement of personnel

(1) The Clinical establishment shall ensure that all service providers engaged or

empanelled by him are registered under law regulating their registration and in the absence

of such law, hold such qualifications and/or possess such experience as to provide care to

patients.

(2) Each such engagement or empanelment shall be substantiated by an offer letter issued

by the clinical establishment and an acceptance letter by the service provider: except where

the proprietor and the service provider is the same person.

(3) The Clinical establishment shall ensure that any service providers engaged in the

clinical establishment submits all particulars relating to his registration, qualification,

training, experience and skill and the No Objection Certificate.

(4) The Clinical establishment shall retain such offer letter or acceptance letter and copies

of such certificates of Registration and certificate of qualification and shall produce such

documents at the time of inspection or enquiry or on demand by the authority.

Explanation: (i) “Certificate of registration” means the registration certificate awarded

by the respective council in case of Registered Medical Practitioner, Registered Nurse or

Midwife, and Registered Paramedical Technician.

(ii) “Certificate of qualification” means the certificate, diploma or degree awarded by

university or any such competent authority.

(5) Every Clinical establishment shall comply with minimum qualification in respect of

health service providers and other persons as specified in Table II in rule 4.

(6) The authority shall have the power to seek reasonable assistance from any authority to

verify the authenticity, the applicability and appropriateness of any such qualification in

such a manner as he deems fit.

(7) A patient or patient has the right to know-

(a) the method of identification of staff through uniforms, badges or other methods; and

(b) the names and professional status of the staff providing care or treatment to the

patient.

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(8) An identity card issued under the signature of the Proprietor of clinical establishment

with more than 30 beds shall include but not limited to the following particulars-

(a) the name of the clinical establishment and its License Number.

(b) the name, designation, and prefix, suffix, where applicable.

(c) a recent photograph of the staff; and

(d) the signature.

(e) any other relevant particulars.

(9) The identity card shall be worn by the staff when he is in the premises.

In case of clinical establishment with less than or equal to 30 beds, Tag mentioning name

and designation of the staff shall be provided by proprietor of Clinical Establishment.

II Availability of Manpower

(1) Every Clinical establishment shall comply with the provisions of rule 5 and other norms

with respect of health service providers.

(2) The Proprietor of clinical establishment shall—

(a) generate and maintain an up-to-date Staff Register in which names, designation,

present and permanent addresses, qualification(s), date of engagement etc. of all staff of the

clinical establishment shall be entered; and

(b) generate and maintain an up-to-date Register in which attendance of all staff of the

clinical establishment are to be recorded daily.

(3) Failure to put signature in daily attendance by any staff shall be considered as

contravention resulting in minor deficiency under the Act.

6. Maintenance of medical record and reporting by Clinical Establishment.— (1) The clinical

establishment shall maintain the following medical records and submit following reports

namely:

Mandatory Record Keeping

(i) clinical establishment shall generate and maintain,-

(a) a record of health case sheet of every patient.

(b) a register for in-patient.

(c) a staff register.

(d) a staff attendance register.

Explanation: In the in-patient register, the name and particulars of all the patients admitted

including the child born to a woman admitted there have to be registered and recorded even if

the new-born may not be sick. Child born to admitted women shall be registered as separate

patient only if the child born is sick and requires special medical and nursing care.

(ii) Where an entry made in the IPD register referred in sub-clause (i) above relates to a

woman who has been admitted for delivery, and a child born to such woman is removed with

the consent of the clinical establishment and of the parents, or near relative then such clinical

establishment shall in addition to the particulars specified in sub-clause (i), also specify in the

register the name and address of the person who has taken custody of the child and the date

on which and the reasons for which the child was so removed.

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(iii) The hard copy of the registers shall have machined-pressed page number and shall be

duly authenticated by the Proprietor.

(iv) The records and register shall bear the name of the clinical establishment along with the

License number.

(v) Similarly all documents and stationary including treatment charts, reports, cash memo,

bill etc. used by the clinical establishment shall bear the name of the clinical establishment.

(vi) Hard Copies of all records, register and documents shall be kept in the record room for at

least five years or in the event of any proceeding till the final disposal of the proceeding.

(vii) The records, registers and documents shall be entered fully, chronologically and legibly

and shall not be tampered with.

(viii) The Proprietor of the clinical establishment shall ensure that all the Registered Medical

Practitioners of the clinical establishment are following the guideline of Medical record keeping

issued by the Medical Council of India or the guidelines as may be notified from time to time.

(ix) Every record, register and document generated and maintained by the Clinical

Establishment shall be open to inspection by the Authority or any other officer specifically

empowered in his behalf.

(x) All reports, medical, medico-legal, mandatory or of any kind generated by the Clinical

establishment shall be signed in ink and properly dated and shall be produced at the time of

inspection or enquiry or on demand by the authority.

B. Mandatory Display

(i) At a conspicuous place in the premises of the clinical establishment be displayed the

license in original so as to be visible to everyone visiting such establishment.

(ii) At reception area and other conspicuous place(s), the clinical establishment shall make

available Information Display Board(s) containing appropriate, adequate and comprehensive

information written in both the local and English language in a manner understood by a non

technical person.

(iii) Information mentioned in clause (ii) shall include but not limited to-

(a) the name of the establishment with names of the Proprietors along with the license

Number;

(b) the system(s) of medicine practiced, types and availability of health care and other

services;

(c) name of empanelled service providers including visiting consultant, if any;

(d) availability of concession of rate of charges, if any;

(e) full contact details of the Grievance Officer with clear mention of the time of availability

of the same;

(f) any other notice or information that may be required by the Authority or any Other

statutory authority;

(g) in case of collection centre, the name and License Number of the mother laboratory

and a certificate of affiliation; and

(h) Any other aspects of healthcare services, which may be of use to the public.

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(iv) At reception area and other conspicuous place(s), the clinical establishment shall make

available an Information Brochure containing appropriate, adequate and comprehensive

information, written in both the local and English language for the benefit of the service

recipient.

(v) Information mentioned under this sub clause (iv) shall include but not limited to-

(a) All information mentioned under sub-clause (iii);

(b) name, qualification, contact number of empanelled service provider including

consultant, if visiting any;

(c) Schedules and timetables of visits of empanelled service providers including

visiting consultant, if any;

(d) Working hours/timings of each Unit of the Clinical Establishment;

(e) Schedule of rate of charges payable for each type of services.

(vi) The clinical establishment shall submit a copy of Information, Brochure mentioned under

sub-clause (iv) to the Authority along with the application for grant or renewal of license.

(vii) The clinical establishment shall inform the authority without delay on the amendments

if any made in the information displayed.

(viii) Insurance empanelment.

(C) Mandatory Reporting:

(i) The clinical establishment shall report all births and deaths occurring in the clinical

establishment to the appropriate authority within stipulated time. Reporting as regards

various programmes, notified diseases and acts of Central/State Government shall be

responsibility of the clinical establishment.

(ii) The clinical establishment shall submit a report regarding any unforeseeable or

unanticipated events that has occurred at the clinical establishment to appropriate authority

with a copy to the Authority by the next working day after the incident occurred or

immediately after the incident occurred.

(iii) The reporting of unforeseeable or unanticipated events shall include, at a minimum,

the following information:

(a) death of patient of the clinical establishment from unexplained cause or under

suspicious circumstances, assault, battery 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) fire in the clinical establishment resulting in death or personal injury; or

(c) any act of violence or damage to the property; 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

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(e) confined or suspected outbreak of any disease; or

(f) any form of closure of suspension of work along with any follow up action taken or

any other information whichever is relevant to the events.

(iv) The clinical establishment shall retain, for at least such period as specified under any

written law pertaining to limitation period, all the information about investigation and findings

regarding unforeseeable or unanticipated events so reported under clause (i).

(v) The Authority may demand further information of the unforeseeable or unanticipated

events from the clinical establishment or any other person if he determines that the information

is necessary for further investigation.

(vi) Clinical establishment shall not discriminate or retaliate against any person who in good

faith provides any information under sub-clause (ii) or gives any evidence in any proceedings

against the Clinical establishment or any person.

7. Classification of Clinical Establishments.— The Clinical Establishments of different

systems shall be classified as under:

The Allopathic Hospitals will be broadly classified under following four levels:

(A) Hospital Level 1 (A) —

General Medical services with indoor admission facility provided by recognized allopathic

medical graduate(s) and may also include general dentistry services provided by recognized

BDS graduates.

Example: PHC, Government and Private Hospitals and Nursing Homes run by MBBS Doctors

etc.

(B) Hospital Level 1 (B) –

This level of hospital shall include all the general medical services provided at level 1(A)

above and specialist medical services provided by Doctors from one or more basic specialties

namely General Medicine, General Surgery, Paediatrics, Obstetrics & Gynaecology and

Dentistry, providing indoor and OPD services.

Level 1(A) and Level 1(B) Hospitals shall also include support systems required for the

respective services like Pharmacy, Laboratory, etc.

Example: General Hospital, Single/Multiple basic medical Specialties provided at Community

Health Centre, Sub Divisional Hospital, and Private Hospital of similar scope, Nursing Home,

Civil/District Hospital in few placed etc.

(C) Hospital Level 2 (Non-Teaching)

This level may include all the services provided at level 1(A) and 1(B) and services through

other medical specialties given as under, in addition to basic medical specialty given under 1

(B) like:—

Orthopaedics

ENT

Ophthalmology

Dental

Emergency with or without ICU

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Anaesthesia

Psychiatry

Skin Pulmonary Medicine

Rehabilitation, etc.

And support systems required for the above services like Pharmacy, Laboratory, Imaging

facilities, Operation Theatre etc.

Example: District Hospital, Corporate Hospitals, Referral Hospital, Regional/State Hospital,

Nursing Home and Private Hospital of similar scope etc.

(D) Hospital Level 3 (Non-Teaching) Super-specialty services—

This level may include all the services provided at level 1(A), 1(B) and 2 and services of one

or more or the super specialty with distinct department and/or also Dentistry if available. It will

have other support systems required for services like pharmacy, laboratory, and Imaging

facility, Operation Theatre etc.

Example: Corporate Hospitals, Referral Hospitals, Regional/State Hospital, Nursing Home

and Private Hospital of similar scope etc.

(E) Hospital Level 4 (Teaching)–

This level will include all the services provided at level 2 and may also have Level 3 facilities.

It will however have the distinction of being teaching/training institution and it may or may not

have super specialties. Tertiary healthcare services at this level can be provided through

specialists and may be super specialists (if available). It will have other support systems

required for these services. It shall also include the requirement of MCI/other registering body

for teaching hospitals and will be governed by their rules. However registration of teaching

Hospitals will also be required under Clinical Establishment Act for purpose other than those

covered under MCI such as, records maintenance and reporting of information and statistics,

and compliance to range of rates for Medical and Surgical procedures, etc.

The categorisation of clinical establishments based on location, ownership, systems of

medicine, type, size, services offered, specialty, etc. are as follows:

(a) Location:

Rural

Urban

Metro

Notified/inaccessible areas (including Hilly/tribal areas)

(b) Ownership:

(a) Government/Public

(i) Central Government

(ii) State Government

(iii) Local Government (Municipality, Zillaparishad, etc)

(iv) Public Sector Undertaking

(v) Other ministries and departments (Railways, Police, etc.)

(vi) Employee State Insurance Corporation

(vii) Autonomous organization under Government

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(b) Non-Government/Private.

(i) Individual Proprietorship

(ii) Partnership

(iii) Registered companies (registered under central/provincial/state Act)

(iv) Society/trust (Registered a central/provincial/state Act)

(c) Systems of Medicine in the establishment

(a) Allopathy (modern medicine)

(b) Any one or multiple disciplines of AYUSH (as defined by the Ministry of AYUSH, GOI)

(d) Type/size:

The type and size of clinical establishments shall be as under:

(1) Clinics (outpatient)— The Clinics shall be categorized as follows:

• Single practitioner (Consultation services only/with diagnostic services/with shortstay)

• Polyclinic (Consultation services only/with diagnostic services/with shortstay)

• Dispensing

• Health Check up Centre

(2) Day Carefacility

• Medical/Surgical

• Medical SPA

• Wellness centres (where qualified medical professionals are available to supervise the

services).

(3) Hospitals including Nursing Home (outpatient and inpatient)-a health care institution

providing patient treatment by specialized staff and equipment.

The Hospitals including Nursing Homes should be categorized based on the following

criteria.

• General Practice

• Single specialty

• Multi-specialty (including Palliative care Centre, Trauma Centre, Maternity Home)

• Super speciality

The fields of clinical medical and surgical specialty and super specialty shall be as per list of

Medical Council of India regulation and currently it will cover following:

(a) Medical Specialties.— for which candidates must possess recognized post graduate

degree of M.D. (DOCTOR OF MEDICINE) or Diploma (or its equivalent recognized

degree/diploma)

d) Anesthesiology

e) Aviation Medicine

f) Community Medicine

g) Dermatology, Venerology and Leprosy

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h) Family Medicine

i) General Medicine

j) Geriatrics

k) Immuno Haematology and Blood Transfusion

l) Nuclear Medicine

m) Paediatrics

n) Physical Medicine Rehabilitation

o) Psychiatry

p) Radio-diagnosis

q) Radio-therapy

r) Rheumatology

s) Sports Medicine

t) Tropical Medicine

u) Tuberculosis & Respiratory Medicine or Pulmonary Medicine

(b) Surgical specialties.— for which candidates must possess, recognized degree of M.S.

(MASTER OF SURGERY) or Diploma (or its equivalent recognized degree).

a) Otorhinolaryngology

b) General Surgery

c) Ophthalmology

d) Orthopaedics

e) Obstetrics & Gynaecology including MTP & Artificial Reproductive Techniques (ART)

Centres

(c) Medical Super specialties–

a) Cardiology

b) Clinical Hematology including Stem Cell Therapy

c) Clinical Pharmacology

d) Endocrinology

e) Immunology

f) Medical Gastroenterology

g) Medical Genetics

h) Medical Oncology

i) Neonatology

j) Nephrology

k) Neurology

l) Neuro-radiology

d) Surgical Super specialties—

a) Cardiovascular thoracic Surgery

b) Urology

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c) Neuro-Surgery

d) Paediatrics Surgery.

e) Plastic & Reconstructive Surgery

f) Surgical Gastroenterology

g) Surgical Oncology

h) Endocrine Surgery

i) Gynecological Oncology

j) Vascular Surgery

As regards to the definition of services provided at specialty and super specialty or multi-

specialty allopathic hospitals the same shall be categorized based on level of care into:

a) Hospital Level 1a

b) Hospital Level 1b

c) Hospital Level 2

d) Hospital Level 3 (Non teaching)

e) Hospital Level 4 (Teaching)

(4) Dental Clinics and Dental Hospital:

a) Dental clinics

i) Single practitioner

ii) Poly Clinics (dental)

b) Dental Hospitals (specialties as listed in the IDC Act)

i) Oral and Maxilla Facial Surgery

ii) Oral Medicine Andradiology

iii) Orthodontics

iv) Conservative Dentistry and Endodontics

v) Periodontics

vi) Pedodontics and Preventive Edentistry

vii) Oral Pathology and Microbiology

viii) Prosthodontics and Crownbridge

ix) Public Health Dentistry

(5) Diagnostic Centers

a) Medical Diagnostic Laboratories: There are two main types of labs that process the

majority of medical specimens. Hospital laboratories are attached to a hospital, and perform

tests on patients. Private (or community) laboratories receive samples from general

practitioners, insurance companies, clinical research sites and other health clinics for analysis.

These can also be called reference laboratories where more unusual and obscure tests are

performed. Clinical Laboratories could be general Labs and/or Advanced Labs that provide

services in the following fields:

Pathology

Bio-chemistry

Microbiology

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Molecular Biology and Genetic Labs

Virology

b) Diagnostic Imaging centres: Diagnostic Imaging centres could be general and/or

Advanced that provide following services:

i) Radiology

General radiology

Interventional radiology

ii) Electromagnetic imaging (Magnetic Resonance Imaging (MRI), Positron Emission

Tomography (PET)Scan)

iii) Ultrasound

c) Collection centres for the clinical labs and diagnostic centres shall function under

registered clinical establishment

(6) Allied Health professions:— Allied health professions generally indicate that they are

health professions distinct from medicine, dentistry, pharmacy and nursing. The list of allied

health professions includes but is not limited to the following disciplines:

Audiology

Behavioural health (counselling, marriage and family therapy etc.)

Exercise Physiology

Nuclear medicine technology

Medical Laboratory Scientist

Dietetics

Occupational and Industrial Health

Optometry

Orthoptics

Orthotics and Prosthetics

Osteopathy

Paramedic

Podiatry

Health Psychology/Clinical Psychology

Physiotherapy

Radiation Therapy

Radiography/Medical Imaging

Respiratory Therapy

Sonography

Speech Pathology

(7) AYUSH

Ayurveda Ausadh Chikitsa, Shalya Chikitsa, Shodhan Chikitsa, Rasayana, Pathya Vyavastha

Yoga Ashtang Yoga

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Unani Matab, Jarahat, Ilaj-bit-Tadbeer, Hifzan-e-Sehat

Siddha Maruthuvam, Sirappu Maruthuvam, Varmam Thokknam & Yoga

Homeopathy General Homeopathy

Naturopathy External Therapies with natural modalities Internal Therapies

8. Standards for different categories of Establishments.— In Addition to the minimum

standards of facilities and services as specified in rule 4, the Clinical Establishments of

different categories shall have following standards, namely:—

(A) Allopathy System

The standards for Allopathic hospitals as classified in rule 7 shall be such as specified in

Appendix I hereto.

(B) Indian System of Medicine and Homoeopathy

I. Consulting Room/Clinic/Polyclinics

1. Building.— The Consulting room shall be spacious, well ventilated and having sufficient

light. The space shall be not less than 100 square feet. There shall be sufficient space for

waiting of the patients etc., If it is a polyclinic, different cubicles shall be available for each

doctor. The names of visiting doctors and their system of medicine shall be exhibited in front of

the clinic.

2. Staff.— The clinics namely, Ayurveda, Yoga and Naturopathy, Unani, Siddha and

Homoepathy Clinics shall be manned by the Registered Medical practitioner. If the pharmacy

attached with the clinic, dispensing of medicines shall be done by a Pharmacist qualified under

the respective system or by the doctor himself.

3. Equipment.— (a) Diagnostic equipment’s ordinarily needed for all AYUSH, Indian System

of Medicine and Homeopathy and Yoga and Naturopathy Clinics:

(i) Thermometer

(ii) Sphygmomanometer

(iii) Stethescope

(iv) Knee hammer

(v) Tongue Depressor

(vi) Torch

(vii) Weighing machine

4. Drugs.— The drugs dispensed to the patients shall contain a label indicating the name of

medicine and the name of patient to whom it is given and quantity to be given etc., the date of

expiry shall be specified in the label, if the drug has an expiry date. The drug to be given

internally and the drug to be used externally shall be indicated and white and red labels to be

provided respectively with clear writing as “For Internal use” or “For External Use” in

vernacular.

5. Records.— A record of all patients seen as to their name, age, sex, diagnosis and

treatment shall be available. The patient shall be provided with a slip with name, age, sex,

diagnosis of treatment given.

(C) General Conditions to be fulfilled by the hospitals under Allopathy and Ayush.

(1) Communication.— A telephone connection shall be available for use by patients (on

payment)

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(2) Security.— Sufficient security shall be provided for the safety of inmates and to prevent

theft.

(3) Fire Fighting.— Fire fighting equipment with I.S.I. mark shall be provided as per rules in

the hospital.

(4) Kitchen.— If food is provided to inmates, the kitchen shall be clean and the cook(s) shall

be periodically, medically examined for any infection or contagious diseases.

(5) Clothing and Linen.— It shall be clean and changed daily.

(6) Water Supply.— The potable water shall be provided to the patient.

(7) Waste Disposal.— It shall be as per the Government of India norms and shall follow the

guidelines of Goa State Pollution Control Board.

(8) Record Maintenance.— (a) Every Clinical Establishment shall maintain the permanent

records pertaining to details of the employees as well as the clinical records pertaining to the

patients. The records shall be kept open for inspection by the competent authority or any other

officer authorized in this behalf.

(b) Every Private Clinical Establishment shall make available a copy of list of observation,

treatment etc., pertaining to the patient on payment of necessary charges within the

reasonable time. Every Clinical Establishment shall display at a prominent place the charges

for obtaining such information.

(c) Every Clinical Establishment may refuse to furnish such information, if such information is

likely to cause injury to the person or his family members or if the treatment has been

conducted on the direction of a public authority.

(D) Diagnostic Labs:

The minimum standards for Diagnostic Laboratories shall be as specified in

Appendix II hereto.

9. Form of Application, fee etc.— (1) An application for certificate of provisional

registration of the Clinical establishment shall be made in Form I hereto and it shall be

accompanied by fees as specified in the table below:

The receipt of such application shall be acknowledge by acknowledgement in Form II

hereto.

TABLE

Description

Urban

Rural

Fee for Provisional

Registration

Fee for

Permanent

Registration

Fee for

Provisional

Registration

Fee for

Permanent

Registration

Out Patient Care

Rs. 500

Rs. 1000

Rs. 250

Rs. 500

In Patient Care

Rs. 1500

Rs. 3000

Rs. 750

Rs. 1500

Testing and

Diagnostic

Rs. 2500

Rs. 5000

Rs. 1250

Rs. 2500

Other fees:

(i) For Renewal, fee will be same as registration fee (Provisional/Permanent).

(ii) For Late Application, enhanced fee equivalent to double of the registration fee for

Provisional/Permanent registration shall be charged.

(iii) For Duplicate Certificate, the fee of Rs 1000/- shall be charged .

(iv) Change of Ownership, Management or Name of Establishment, the fee of Rs 2000/-

shall be charged.

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(v) For any appeal the fee shall be Rs. 1000/-.

If a laboratory or diagnostic centre is a part of a Establishment providing

Outpatient/Inpatient care no separate registration is required if the management is same.

However, fee as applicable above would have to be paid.

10. Form of Certificate of Provisional registration.— The Certificate of provisional registration

shall be issued to the establishment in Form III hereto.

11. Manner of Publication of Particulars of Clinical Establishment.— The particulars of the

Clinical Establishment registered provisionally shall be published by uploading the same on

the official website of the respective Collector.

12. Fee for duplicate certificate:— A duplicate certificate shall be issued under section 16 on

payment of fee as specified in rule 9.

13. Manner of Informing change of ownership/management:— The Clinical establishment

shall inform the authority of any change in ownership or management in Form IV hereto within

a period of one month from the date of such change and make application for fresh certificate of

provisional registration, as the case may be, which shall be accompanied by fee as specified in

rule 9.

14. Publication of expiry of registration:— The authority shall in the month of December of

every year publish the names of all clinical establishments whose registration has expired, in

atleast two local newspapers having vide circulation in the State and also on the official

website of the respective Collector.

15. Application for Certificate of Permanent registration:— 1) Every application for certificate

of permanent Registration shall be made in Form V hereto and it shall be accompanied by fee

as specified in rule 9.

2) The receipt of such application shall be acknowledged in Form II hereto.

16. Submission of Evidence:— The Clinical Establishment shall submit evidence of having

complied with the prescribed minimum standards in Form VI hereto.

17. Display of information for filing objection:— The evidence submitted by the Clinical

Establishment of having complied with prescribed minimum standards shall be displayed on

official website by the Authority by a public notice for inviting objections, if any, in form VII

hereto.

18. Certificate of Permanent registration:— The Authority shall issue a certificate of

permanent registration to the clinical establishment under sub-section (1) of section 27 of the

Act in VIII hereto.

19. Fee for renewal of permanent registration:—

The renewal fee and the enhanced fee referred in sub-section (4) of section 27, shall be as

specified in rule 9.

20. Manner of Entry and Search:— (1) Entry and search of the Clinical Establishment may be

done by the Authority or an officer duly authorized by it or subject to such general or special

orders as may be made by the authority.

(2) Such entry and search of clinical establishment can be conducted if anyone is carrying on

a Clinical Establishment without registration or does not adhere to the prescribed minimum

standards or has reasonable cause to believe that the Clinical Establishment is being used for

purposes other than that it is registered or contravenes any of the provisions of the Goa

Clinical Establishments (Registration and Regulations) Act, 2019 (Goa Act No. 19 of 209) and

the rules frame there under.

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(3) The inspection team shall at all reasonable times enter and inspect any record, register,

document, equipment and articles as deemed necessary.

(4) The inspection team shall normally intimate the Clinical Establishment in writing about

the date of visit. The team shall examine all portions of the premises used or proposed to be

used for the Clinical Establishment and inspect the equipments, furniture and other accessories

and enquire into the professional qualifications of the technical staff employed or to be

employed and shall make any such other enquires as they consider necessary to verify the

statements made in the application for registration and grant of license.

(5) All persons connected with the running of the Clinical Establishment shall be bound to

furnish full and correct information to the inspection team. Surprise inspections may also be

conducted by the inspection teams.

(6) The Officer and/or inspection team so constituted by the authority shall submit a report in

form 9 hereto within fifteen days of the inspection to the authority with a copy to the council.

21. Fee for different category of Establishments:— (1) The fee for different category of

establishments shall be as specified in rule 9.

(2) All fees shall be paid either by a demand draft or bank challan or through online mode of

payment.

(3) The fees shall be deposited by the Authority in an account opened by the Council in a

nationalised bank and such sum be utilized by Council for the activities connected with the

implementation of the provisions of the Act.

22. Appeal:— (1) An Appeal under section 33 shall be preferred to the Council within a

period of 30 days from the date of passing of the Order by authority or from the date of receipt

of Order by the Clinical Establishment, whichever is later.

(2) Such an appeal shall be filed in form X hereto and it shall be accompanied by fees as

specified in rule 9.

(3) After receipt of the appeal, the Council shall fix the time and date for hearing and issue

notice hereof to the appellant and the authority.

(4) The appellant may represent himself or through an authorized person or a Legal

practitioner and submit the relevant documentary material, if any, in support of the appeal.

(5) The Council shall hear all the concerned, receive the relevant oral/documentary evidence

submitted by them, consider the appeal and communicate its decision preferably within a

period of ninety days from the date of filing of the Appeal.

(6) If the Council considers that an interim order is necessary in the matter, it may pass such

order, pending final disposal of the appeal.

(7) The decision of State Council shall be final and binding.

(8) If no appeal is filed against the decision of the Authority within the specified period, the

decision shall be final.

(9) The fees collected by the authorities shall be deposited in a nationalized bank account

opened by the Council and shall be utilized by the Council for the activities connected with the

implementation of the provisions of the Act.

23. Register of Clinical Establishments:— The Authority shall maintain a digital register of

Clinical Establishments registered by it in form XI hereto.

24. Returns, Statistics and Other information:— A Clinical Establishment shall furnish

returns, statistics to the authority in Form XII hereto within thirty days of end of every quarter

of an year.

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25. Inquiry.— The Authority shall issue a show cause notice to the Clinical Establishment

and to the person who carries on Clinical Establishment seeking a reply within fifteen days of

receipt of notice. The authority shall provide a hearing to such person before passing any order.

By Order and in the name of the Governor of Goa.

Gautami Parmekar, Under Secretary (Health-II).

Porvorim, 5th July, 2021.

_____

FORM I

[See Rule 9(1)]

Application for Certificate of Provisional Registration of Clinical Establishment

1. Name of the Establishment/Doctor:___________________________

(in case of Single Practitioner): _______________________________

2. Address:_________________________________________

Village/Town:_________________ State:________________________

Pin Code:_________________ Tele/Mobile No.: ______________________

Website :_________________________________

3. Name of the Owner:

Address:_______________________

Village/Town:_______________________ State:______________

Pin Code: _______________ Tele/Mobile:_________________

Website:_________________________

3a. Name of person in-charge and Qualification:_________________________

_______________________________________________________________

4. Ownership:

a) Public Sector: Central Government

State Government

Local Government

Public Sector Undertaking

Any other (Please specify)

b) Private Sector: Individual Proprietorship

Registered Partnership

Registered Company

Co-operative Society

Trust/charitable

Any other (Please specify)

5. Systems of Medicine offered: (please tick whichever is applicable)

* Allopathy

* Ayurveda

* Unani

* Siddha

* Homeopathy

* Yoga & Naturopathy

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6. Services provided: (Please tick whichever is applicable)

*Inpatient

*Outpatient

*Laboratory/Imaging Centre

*Any other (Please specify)

a) Category of Clinical Services:

* General

* Single Specialty

* Multi Specialty

* Super Specialty

7 Type of Establishment: (please tick whichever is applicable)

a) Inpatient

*Hospital

*Nursing Home

*Maternity Home

*Primary Health Centre

*Community Health Centre

*Sanatorium

*Day Care Centre

b) No. of Beds:_________________

c) Outpatient: * Single practitioner

* Polyclinic

* Sub Centre

* Physiotheraphy Clinic

* Dialysis Centre

* Any other (please specify)

d) Laboratory:* Pathology

* Haematology

* Biochemistry

* Microbiology

* Genetics

* Collection Centre

* Any other (please specify)

e) Imaging Centre (Please specify)

Special diagnostic: Please specify: ________________________________

I hereby declare that the statements above are correct and true to the best of my knowledge and shall

abide all the rules and declarations under the Clinical Establishment (Registration and Regulation) Act,

2010. I undertake that I shall intimate to the appropriate registering authority any change in the

particulars given above.

Date:

Signature of authorized signatory

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FORM II

[See Rule 9(2) and rule 16(2)]

ACKNOWLEDGMENT OF CERTIFICATE OF PROVISIONAL/PERMANENT

REGISTRATION OF CLINICAL ESTABLISHMENT

The application in Form______________ for Grant/Renewal of Provisional/Permanent registration of

the Clinical Establishment submitted by _____________________________________________(name and

address of owner) has been received by the District Registration Authority on _________________(date)

and found to be

Complete

Or

Incomplete

This acknowledgement does not confer any rights on the applicant for grant or renewal of

registration.

Signature and Designation of Registration Authority or authorised person in the Office of the

Appropriate Authority.

Seal

Designation of the Issuing Authority

Place and Date

_____

FORM III

[See Rule (10)]

CERTIFICATE OF PROVISIONAL REGISTRATION OF CLINICAL ESTABLISHMENT

Provisional Registration No. (Computer generated)

Date of Issue:(Computer generated)

Valid upto:(Computer generated)

1. Name of the Clinical Establishment:_________________________________

2. Address:____________________________________________________________

3. Owner of the Clinical Establishment:_________________________________

4. Name of Person In charge:___________________________________________

5. System of Medicine:_________________________________________________

6. Type of Establishment:______________________________________________

Is hereby provisionally registered under the provisions of Clinical establishments (Registration and

Regulation) Act, 2019 and the Rules made there under.

This authorization is subject to the conditions as specified in the said Act and rules made there under.

Seal

Designation of the Issuing Authority

Place and Date

District Registration Authority

Address:

Phone Number in case of Grievances

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FORM IV

[See Rule (13)]

INFORMATION ON CHANGE OF OWNERSHIP/MANAGEMENT OF CLINICAL

ESTABLISHMENT

To,

The District Registering Authority

Clinical Establishments Act & Rules

Sir/Madam,

I, Dr./Shri……………………………………………….…….. hereby inform you that there is change in the

ownership/management of the establishment by name…………………………………………….. having

permanent/provisional registration No. ……………………… dated………located at…………………….and

owned/managed by…………………………….

The new management/ownership is as under:

1. Name of the clinical establishment:

2. Address:

3. Owner of the clinical establishment:

4. Name of the person in charge:

5. System of medicine:

6. Type of establishment:

I hereby surrender the old certificate of Registration and request you to issue new certificate of

Registration by incorporating the abovementioned changes.

I am enclosing herewith draft of Rs. ……………

Thanking you,

Place

Date

Signature and Name

_____

FORM V

[See Rule (15)]

APPLICATION FOR CERTIFICATE OF PERMANENT REGISTRATION

I. ESTABLISHMENT DETAILS

1. Name of the establishment:_________________________________________

2. Address: ____________________________________________________________

Village/Town:_______________________________Block:__________________

District:_____________________State_______________Pincode____________

Tel No.(with STD code):_____________Mobile:_____________Fax:_________

Email ID:______________________________Website(if any)______________

3. Month and Year of starting:

(From 4 to 11 mark all whichever are applicable)

4. Location:

Rural Urban Metro

Notified/inaccessible areas (including Hilly/tribal areas)

5. Ownership of Services

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Government/Public

Sector

Central

Government

State

Government

Local

Government

(Municipality, Zilla parishad, etc.)

Public Sector Undertaking Other ministries and Departments (Railways, Police, etc.) Employee

State Insurance Corp Autonomous organization under Government.

Non-Government/Private Sector

Individual Proprietorship Partnership Registered companies (registered under central/provincial/

/State Act) Society/trust (Registered under central/provincial/state Act)

6. Name of the owner of Clinical Establishment:

Address:

Village/Town:____________________Block:_______________District:_______ State: Pin code:________

Tel No (with STD code):

Mobile:

Fax:

Email ID:

7. Name, Designation and Qualification of person in-charge of the Clinical Establishment:__________

Qualification(s):____________________________________________________

Registration Number:_______________________________________________

Name of Central/State Council (with which registered): ______________

Tel. No. (with STD code): _____________ Fax:_______ Mobile: _____________

E-mail ID:__________________________________________________________

8. Systems of Medicine offered: (please tick whichever is applicable)

Allopathy Ayurveda Unani Siddha Homoeopathy

Yoga Naturopathy Sowa-Rigpa

9. Type of establishment: (please tick whichever is applicable)

(I). Clinic (Outpatient)

• Single practitioner

(Consultation services only/with diagnostic services/with short stay facility)

• Polyclinic

(Consultation services only/with diagnostic services/with short stay facility)

• Dispensary

• Health Checkup Centre

(II). Day Care facility

Medical Surgical Medical SPA Wellness centers (where qualified medical professionals are

available to supervise the services).

(III). Hospitals including Nursing Home (outpatient and inpatient):

• Hospital Level 1a

• Hospital Level 1b

• Hospital Level 2

• Hospital Level 3 (Nonteaching)

• Hospital Level 4 (Teaching)

(IV). Dental Clinics and Dental Hospital:

a. Dental clinics

i.

Single practitioner

ii. Poly Clinics(dental)

b. Dental Hospitals (specialties as listed in the IDC Act.)

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i.

Oral and maxilla facials surgery

ii.

Oral medicine and radiology

iii. Orthodontics

iv. Conservative dentistry and Endodontics

v.

Periodontics

vi. Pedodontics and preventive dentistry

vii. Oral pathology and Microbiology

viii. Prosthodontics and crown bridge

ix. Public health dentistry

(V) Diagnostic Centre

A. Medical Diagnostic Laboratories:

Pathology Biochemistry Microbiology

Molecular Biology and Genetic Labs Virology

B. Diagnostic Imaging center’s

i. Radiology

•

General radiology

•

Interventional radiology

ii. Electromagnetic imaging

•

Magnetic Resonance Imaging(MRI)

•

Positron Emission Tomography (PET)Scan

iii. Ultrasound

C. Miscellaneous

•

Electro Cardio Graphy (ECG)

•

Eco cardiography

•

Tread Mill test

•

Electro MyoGraphy (EMG)

•

Electro Encephalo Graphy (EEG)

•

Electrophysiological studies

•

Mammography

D. Collection centres

For the clinical labs and diagnostic centres shall function under registered clinical

establishment

Yes/No

If yes, then No. of Collection Centre:

VI) Allied Health Professions:

• Audiology

• Behavioural health (counselling, marriage and family therapy etc.)

• Exercise physiology

• Nuclear medicine technology

• Medical Laboratory Scientist

• Dietetics

• Occupational therapy

• Optometry

• Orthoptics

• Orthotics and prosthetics

• Osteopathy

• Paramedic

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• Podiatry

• Health Psychology/Clinical Psychology

• Physiotherapy

• Radiation therapy

• Radiography/Medical imaging

• Respiratory Therapy

• Sonography

• Speech pathology

(VII) AYUSH

Ayurveda

Ausadh Chikitsa Shalya Chikitsa Shodhan Chikitsa Rasayana Pathya Vyavastha

Yoga

Ashtang Yoga

Unani

MatabJarahat Ilaj-bit-Tadbeer Hifzan-e-Sehat

Siddha

Maruthuvam

Sirappu Maruthuvam Varmam Thokknam & Yoga

Homoeopathy

General Homoeopathy

Naturopathy

External Therapies with natural modalities

Internal Therapies

II. TYPES OF SERVICE

•

TYPE

General Practice Services

Single Specialty Services

Multi Specialty Services (including Palliative care Centre, Trauma Centre, Maternity Home -

applicable for hospitals only)

Super Specialty Services

•

SPECIALITY SPECIFIC

Medical Specialties – for which candidates must possess recognized PG degree

(MD/Diploma/DNB or its equivalent degree)

i.

Anesthesiology

ii.

Aviation Medicine

iii.

Community Medicine

iv.

Dermatology, Venerology and Leprosy

v.

Family Medicine

vi.

General Medicine

vii.

Geriatrics

viii. Immuno Haematology and Blood Transfusion

ix.

Nuclear Medicine

x.

Paediatrics

xi.

Physical Medicine Rehabilitation

xii.

Psychiatry

xiii. Radio-diagnosis

xiv. Radio-therapy

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xv.

Rheumatology

xvi. Sports Medicine

xvii. Tropical Medicine

xviii. Tuberculosis & Respiratory Medicine or Pulmonary Medicine

Surgical specialties - for which candidates must possess, recognized PG degree

(MS/Diploma/DNB or its equivalent degree)

i.

Otorhinolaryngology

ii. General Surgery

iii. Ophthalmology

iv. Orthopedics

v.

Obstetrics &Gynecology

Medical Super specialties –

i.

Cardiology

ii. Clinical Hematology including Stem Cell Therapy

iii. Clinical Pharmacology

iv. Endocrinology

v. Immunology

vi. Medical Gastroenterology

vii. Medical Genetics

viii. Medical Oncology

ix. Neonatology

x. Nephrology

xi. Neurology

xii. Neuro-radiology

Surgical Super-specialities-

i.

Cardiovascular thoracic Surgery)

ii.

Urology

iii. Neuro-Surgery

iv.

Paediatrics Surgery.

v.

Plastic & Reconstructive Surgery

vi.

Surgical Gastroenterology

vii. Surgical Oncology

viii. Endocrine Surgery

ix.

Gynecological Oncology

x.

Vascular Surgery

xi.

III INFRASTRUCTURE DETAILS

10. Area of the establishment (in sq. ft.):

a) Total area:

b) Constructed area:

11. Out Patient Department:

11.1 Total No. of OPD Clinics ________________________

11.2 Specialty-wise distribution of OPD Clinic

S.No.

Specialty

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12. In Patient Department:

12.1. Total number of beds:

12.2. Specialty-wise distribution of beds, please specify:

S.No.

Specialty

Beds

13. Biomedical Waste Management

13.1

Method of treatment and/or disposal of Bio-medical waste

Through Common Facility

Onsite Facility

Any other (please specify):_______________

13.2. Whether authorization from Pollution Control Board/Pollution Control Committee obtained?

Yes

No

Applied For

Not Applicable

IV HUMAN RESOURCES

14. Total number of Staff (as on date of application):

No. of permanent staff :

No. of temporary staff :

Please furnish the following details:-

Category of staff

Name

Qualification

Registration No.

Nature of service

Temporary/Permanent

Doctors

Nursing staff

Para-medical staff

Pharmacists

Administrative staff

Others, please

specify

Separate annexure may be attached

Support staff

Category

Total No.

Remark

15. Payment options for Registration Fees:

Online payment

Demand Draft

Bank Challan

Amount (in Rs.):

Details:

Receipt No.

I,………………………………………………..……………on behalf of myself and the company/society/

/association/body hereby declare that the statements above are correct and true to the best of my

knowledge and I shall abide by all the provisions made under the Clinical Establishment (Registration

and Regulation) Act, 2019 and the rules framed thereunder.

I undertake that I shall inform the District Registering Authority of any changes in the particulars

given above.

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I shall comply with the minimum standards prescribed under the said Act, 2019 for the

services provided by us and also all other conditions of registration as stipulated under the

aforesaid Act and Rules made there-under.

Place: Signature of the Authorized Signatory

Date: Office Seal

_____

FORM VI

[See Rule (16)]

FORM OF EVIDENCE OF COMLIANCE OF PRESCRIBED MINIMUM STANDARDS BY CLINICAL

ESTABLISHMENT

1. Name, Designation and Qualification of person in-charge of the Clinical Establishment:_____________

Qualification(s): ____________________________________________________

Registration Number: _______________________________________________

Name of Central/State Council (with which registered): ______________

Tel. No. (with STD code): _____________Fax: _______Mobile: _____________

E-mail ID: __________________________________________________________

2. Systems of Medicine offered: (please tick whichever is applicable)

Allopathy Ayurveda Unani Siddha Homoeopathy Yoga Naturopathy Sowa-Rigpa

3. Type of establishment: (please tick whichever is applicable)

(I) Clinic (Outpatient)

• Single practitioner

(Consultation services only/with diagnostic services/with short stay facility)

• Polyclinic

(Consultation services only/with diagnostic services/with short stay facility)

• Dispensary

• Health Check-up Centre

(II) Day Care facility

Medical Surgical Medical SPA Wellness centers (where qualified medical professionals are available

to supervise the services).

(III) Hospitals including Nursing Home (outpatient and inpatient):

• Hospital Level 1a

• Hospital Level 1b

• Hospital Level 2

• Hospital Level 3 (Non teaching)

• Hospital Level 4 (Teaching)

(IV) Dental Clinics and Dental Hospital:

(a) Dental clinics

(i) Single practitioner

(ii) Poly Clinics (dental)

(b) Dental Hospitals (specialties as listed in the IDC Act)

a) Oral and maxilla facials surgery

b) Oral medicine and radiology

c) Orthodontics

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d) Conservative dentistry and Endodontics

e) Periodontics

f) Pedodontics and preventive dentistry

g) Oral pathology and Microbiology

h) Prosthodontics and crown bridge

i) Public health dentistry

(V) Diagnostic Centre

A. Medical Diagnostic Laboratories:

Pathology

Biochemistry Microbiology

Molecular Biology Genetic Labs Virology

B. Diagnostic Imaging centers

i. Radiology

• General radiology

• Interventional radiology

ii. Electromagnetic imaging

• Magnetic Resonance Imaging (MRI),

• Positron Emission Tomography (PET) Scan

iii. Ultrasound

C. Miscellaneous

a) Electro cardio Graphy (ECG)

b) Eco cardiography

c) Tread Mill test

d) Electro MyoGraphy (EMG)

e) Electro EncephaloGraphy (EEG)

f)

Electrophysiological studies

g) Mammography

D. Collection centres

For the clinical labs and diagnostic centres shall function under registered clinical establishment

Yes/No

If yes, then No. of Collection Centre:

VI) Allied Health Professions:

a) Audiology

b) Behavioural health (counselling, marriage and family therapy etc.)

c) Exercise physiology

d) Nuclear medicine technology

e) Medical Laboratory Scientist

f)

Dietetics

g) Occupational therapy

h) Occupational &Industrila Health

i)

Optometry

j)

Orthoptics

k) Orthotics and prosthetics

l)

Osteopathy

m) Paramedic

n) Podiatry

o) Health Psychology/ Clinical Psychology

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p) Physiotherapy

q) Radiation therapy

r)

Radiography/Medical imaging

s) Respiratory Therapy

t)

Sonography

u) Speech pathology

(VII) AYUSH

Ayurveda

AusadhChikitsa Shalya Chikitsa ShodhanChikitsa Rasayana Pathya Vyavastha

Yoga

Ashtang

Yoga

Unani

MatabJarahat Ilaj-bit-Tadbeer Hifzan-e-Sehat

Siddha

Maruthuvam Sirappu Maruthuvam Varmam Thokknam & Yoga

Homoeopathy

General Homoeopathy

Naturopathy

External Therapies with natural modalities Internal Therapies

II. TYPES OF SERVICE

• TYPE

General Practice Services

Single Specialty Services

Multi-Specialty Services (including Palliative care Centre, Trauma Centre, Maternity Home - applicable

for hospitals only)

Super Specialty Services

• SPECIALITY SPECIFIC

Medical Specialties – for which candidates must possess recognized PG degree (MD/Diploma/DNB or its

equivalent degree)

a) Anesthesiology

b) Aviation Medicine

c) Community Medicine

d) Dermatology, Venerology and Leprosy

e) Family Medicine

f)

General Medicine

g) Geriatrics

h) Immuno Haematology and Blood Transfusion

i)

Nuclear Medicine

j)

Occupational & Industrial Health

k) Paediatrics

l)

Physical Medicine Rehabilitation

m) Psychiatry

n) Radio-diagnosis

o) Radio-therapy

p) Rheumatology

q) Sports Medicine

r)

Tropical Medicine

s) Tuberculosis & Respiratory Medicine or Pulmonary Medicine

Surgical specialties for which candidates must possess, recognized PG degree (MS/Diploma/DNB or its

equivalent degree)

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a) Otorhinolaryngology

b) General Surgery

c) Ophthalmology

d) Orthopedics

e) Obstetrics &Gynecology

Medical Super specialties—

a) Cardiology

b) Clinical Hematology including Stem Cell Therapy

c) Clinical Pharmacology

d) Endocrinology

e) Immunology

f)

Medical Gastroenterology

g) Medical Genetics

h) Medical Oncology

i)

Neonatology

j)

Nephrology

k) Neurology

l)

Neuro-radiology

Surgical Super-specialities—

a) Cardiovascular thoracic Surgery)

b) Urology

c) Neuro-Surgery

d) Paediatrics Surgery.

e) Plastic & Reconstructive Surgery

f)

Surgical Gastroenterology

g) Surgical Oncology

h) Endocrine Surgery

i)

Gynecological Oncology

j)

Vascular Surgery

k)

(III) INFRASTRUCTURE DETAILS

4. Area of the establishment (in sq. ft.):

a) Total Area: ____________ b) Constructed area: _______________

5. Out Patient Department:

5.1 Total No. of OPD Clinics:

5.2 Specialty-wise distribution of OPD Clinic

S.No.

Specialty

6. In Patient Department:

6.1 Total number of beds:

6.2 Specialty-wise distribution of beds, please specify:

S.No.

Specialty

Beds

7 Biomedical Waste Management

7.1 Method of treatment and/or disposal of Bio-medical waste

Through Common Facility

Onsite Facility

Any other (please specify):_______________

7.2. Whether authorization from Pollution Control Board/Pollution Control Committee obtained?

Yes

No

Applied For Not Applicable

OFFICIAL GAZETTE — GOVT. OF GOA

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507

IV. HUMAN RESOURCES

8. Total number of staff (as on date of application):

No. of permanent staff : _____ No. of temporary staff : ______

Please furnish the following details:—

Category of staff

Name

Qualification

Registration No

Nature of service

Temporary/ Permanent

Doctors

Nursing staff

Para-medical staff

Pharmacists

Administrative staff

Others, please

specify

Separate annexure may be attached

Support staff

Category

Total No.

Remark

9. List of legal requirements

Below is the list of legal requirements to be complied with by a hospital as applicable by the local/state

health authority (all may not be applicable)

Sr.

No.

Name of Document

Valid

from

Valid till

Send for

renewal

Remark

(Expired/valid/NA)

1

Provisional Registration under

Medical Establishment Act

2

Biomedical Waste Management

licenses

3

No objection certificate under

Pollution Control Act (Air/Water)

4

NOC from Fire Department

5

NOC from sanitary point of view

from concerned PHC

6

Ambulance:

Commercial vehicle permit

Permit from Directorate of Health

Services

7

Building completion licenses

8

Food safety license

9

Medical Gases Licenses/Explosives

Act

10

Blood Bank licenses

11

MOU/Agreement with outsourced

Human resource agencies as per

labour laws.

12

Provident Fund/ESI Act

13

MTP Act

14

PNDT Act

15

PAN

16

Ownership document or Lease

agreement if premises are taken on

rent.

Any other requirements to be complied in accordance with the prevailing law of the State.

OFFICIAL GAZETTE — GOVT. OF GOA

SERIES I No. 15

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8TH JULY, 2021

508

UNDERTAKING

I, ………………………………….……………………………………… on behalf of myself and the company/

/society/association/body hereby declare that the statements above are correct and true to the best of

my knowledge and I shall abide by all the provisions made under the Clinical Establishment

(Registration and Regulation) Act, 2019 and Rules, 2020.

I undertake that I shall inform the District Registering Authority of any changes in the particulars

given above.

I shall comply with the minimum standards prescribed under Clinical Establishment Act for the

services provided by us and also all other conditions of registration as stipulated under the aforesaid Act

and Rule there-under.

Place: Signature of the Authorized Signatory

Date: Office Seal

_____

FORM VII

[See Rule (17)]

PUBLIC NOTICE

The public in general is hereby informed that the Clinical Establishments as specified in column (2) of

the Table below have made applications for certificate of Permanent Registration under section 21, the

Goa Clinical Establishments (Registration and Regulation) Act, 2019 (Goa Act 19 of 2019), and submitted

evidence of prescribed minimum standards in the Forms appended in Annexure hereto.

Objections for granting Certificate of Permanent Registration may be forwarded to the Registering

Authority before expiry of thirty days from the date of issue of this notice.

TABLE

Sr. No.

Name of Clinical

Establishment

with address

Ownership/

/in charge

System of

medicine

Date on which

application was

submitted

Category and

standards complied

with

(1)

(2)

(3)

(4)

(5)

(6)

Place:

Date:

SEAL North/South Goa District

Registering Authority

_____

FORM VIII

[See Rule (18)]

CERTIFICATE OF PERMANENT REGISTRATION OF CLINICAL ESTABLISHMENT

Permanent Registration No.

Date of Issue:

Valid upto:

1. Name of the Clinical Establishment:________________________________________________________

2. Address:________________________________________________________________________________

3. Owner of the Clinical Establishment:_______________________________________________________

4. Name of Person In charge:________________________________________________________________

5. System of Medicine: _____________________________________________________________________

6. Type of Establishment: ___________________________________________________________________

OFFICIAL GAZETTE — GOVT. OF GOA

SERIES I No. 15

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509

Is hereby registered under sub section (1) of section 27 of the Clinical Establishments (Registration

and Regulation) Act, 2019 (Goa Act 19 of 2019).

This authorization is subject to the conditions as specified in the Clinical Establishments (Registration

and Regulation) Rules, 2021.

Seal

Designation of the Issuing Authority

Place and Date

District Registration Authority

Address:

Phone Number in case of Grievances

_____

FORM IX

[See Rule 20]

FORMAT FOR SUBMISSION OF INSPECTION REPORT

Number of visits made with date: ______________________________________________________________

Name and details of members of the inspection team: ____________________________________________

Address and contact details of Clinical Establishment visited: _____________________________________

Process followed for inspection (eg. Kindly outline who was met:___________________________________

With. What records were examined etc.)

Salient Observations/findings conclusions:_______________________________________________________

Specific Recommendations:_____________________________________________________________________

1) To the Clinical Establishment: ________________________________________________________________

2) To the District Registering Authority:__________________________________________________________

*In case of lack of consensus amongst members of the inspection team, the same may be kindly

indicated.

Signature(of all members of the inspection team)

Date:

Place:

_____

Form X

[See Rule 22(2)]

APPEAL MEMO

(Name of the Clinical Establishment)

(Detailed Address)

Contact Nos:______

(Landline)_______

Mobile________

Email id:______________________

Dated:______________________

To,

The Chairman

Goa Council for Clinical Establishments,

(Detailed Address)

Sir/Madam,

I, Dr./Mr./Mrs./Ms.Name______________________of the Clinical establishment, namely____________had

applied for:-

• Grant of certificate of provisional registration in respect of the Clinical establishment, namely _______

OFFICIAL GAZETTE — GOVT. OF GOA

SERIES I No. 15

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510

• Grant of certificate of permanent registration in respect of the Certificate of provisional registration

bearing No. ________________ dated ______________________.

However, _____________Authority vide Order No. __________________dated ___________ has refused

to grant certificate of provisional registration/permanent registration.

----OR----

I, Dr./Mr./Mrs./Ms.________Name_________________________________of the Clinical establishment,

namely,_________________________and holding a Certificate of provisional registration/permanent

registration bearing No. ____________ dated ___________________.

• Vide Application dated __________I had requested the ___________authority to renew the said

Certificate of permanent registration, however, the _______ Authority vide Order No. ______dated

_______ has refused to renew the said Certificate of permanent registration.

• The _________Authority vide Order No._______dated _________ has cancelled/revoked the said

Certificate of provisional registration/permanent registration.

• The ________Authority vide Order No.___dated ______has directed to stop running the Clinical

Establishment.

• The ________Authority vide Order No. ______dated __________has directed to pay a penalty of Rs.

________ for an offence under section _______the ___Act, _______(Goa_N._of _).

• Any other grievance

The above decision of the district authority appears to be not valid. I request you to consider my

application as per the justifications mentioned below:

i)__________________________ ii)_______________________________ iii)__________________________________

I am willing to appear before you for personal hearing,if necessary, I am enclosing herewith a

draft of 1000/-

Thanking you

Place:

Date:

Signature:

Name:

_____

FORM XI

[See Rule (23)]

REGISTER OF CLINICAL ESTABLISHMENTS

Sr.

No.

Name of

Clinical

Establishment

Ownership/

/incharge

System of

medicine

Provisional

Registration

No. and date

Permanent

registration

No. and date

Date of

expiry of

permanent

registration

Remarks

if any