Clinical Establishment Management in India

Medical Laws

The Govt.of India supplements the efforts of State Governments.Clinical Establishments Act (CEA), 2010 was enacted by Government of India for registration and regulation of all Clinical Establishments without which no Clinical Establishment can run its operations. For emergency health care, it is to inform that one of the conditions for registration of Clinical Establishments (CEs) is that the clinical establishment shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such Clinical Establishment. If any Clinical Establishment fails to provide stabilisation of Emergency medical condition as per the Act then it is a violation of the Act and action can be taken by District Registering Authorities.

Legal Framework

Health is a State subject and it is for the State Government to provide health care services.

The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescrib the minimum standards of facilities and services provided by them. The Act has taken effect in the four States namely, Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all Union Territories except the NCT of Delhi since 1st March, 2012 vide Gazette notification dated 28th February, 2012. The States of Uttar Pradesh, Uttarakhand, Rajasthan, Bihar, Jharkhand, Assam and Haryana have adopted the Act under clause (1) of article 252 of the Constitution.[Ministry of Health Govt of India]

As per Rule 9(iii), in the Clinical Establishments (Central Government) Rules 2012, National Council for Clinical Establishments has approved a list of standard procedures  and a template for costing of these procedureswhich has been shared with the implementing States Union Territories. The States have been requested to take into consideration of all pertinent factors including local factors and define such rates.

Revised Indian Public Health Standards (IPHS) Guidelines 2012 were disseminated among States and Union Territories to specify the minimum assured (essential) services that the health centres are expected to provide and the desirable services for States and Union Territories that the health centres should aspire to provide. It is further to inform that Government of India provides budget under National Health Mission for upgradation of Government health facilities (from Sub centre to district hospital levels) to IPHS level through Programme Implementation Plan (PIP) of respective State Government. States are expected to identify gaps in the available facilities vis-à-vis IPHS and make provisions for filling up of gaps and seek funds through State PIP under NHM.

• Clinical Establishments (Central Government) Rules, 2012
• Clinical Establishments (Central Government) Amendment Rules, 2018
• Clinical Establishments (Central Government) Amendment Rules, 2020.
• Recommendations On Electronic Medical Records Standards In India-2013
• OPERATIONAL GUIDELINES FOR CLINICAL ESTABLISHMENTS ACT
• Draft of Patient Charter prepared by National Human Rights Commission-30.08.2018
• Revised Indian Public Health Standards (IPHS) Guidelines 2012
• National Ambulance Service (NAS) guidelines
• Information and Statistics to be collected Monthly from Clinical Establishments under the Clinical Establishment Act
• The right to information Act-2005

National Register of Clinical Establishments

Maintenance of National Register of clinical establishments – The Central Government shall maintain in digital format an All India Register to be called as the National Register of clinical establishments that shall be an amalgam of the State Register of clinical establishments maintained by the State Governments and shall cause the same to be published in digital format.

It shall be the responsibility of the State Council for clinical establishments to compile and update the State Register of clinical establishments of the State and further to send monthly returns in digital format for updating the National Register.

ESSENTIAL DEFINITIONS

Clinical establishment means—

(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or

(ii) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not, and shall include a clinical establishment owned, controlled or managed by—

(a) the Government or a department of the Government;

(b) a trust, whether public or private;

(c) a corporation (including a society) registered under a Central, Provincial or State Act, whether or not owned by the Government;

(d) a local authority; and

(e) a single doctor, but does not include the clinical establishments owned, controlled or managed by the Armed Forces. Explanation.—For the purpose of this clause “Armed Forces” means the forces constituted under the Army Act, 1950, the Air Force Act, 1950 and the Navy Act, 1957; [The Clinical Establishments (Registration and Regulation) Act, 2010]

‘Hospital bed’ means– (WHO defines a hospital bed as) a bed that is regularly maintained and staffed for the accommodation and full-time care of a succession of inpatients and is situated inwards or a part of the hospital where continuous medical care for inpatients is provided. The total of such beds constitutes the normally available bed complement of the hospital.

Nursing Home ‘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.

Clinic- A standalone healthcare facility that provides healthcare services by Doctors. lt is inclusive of Allopathy or/and
AYUSH facility.

Diagnostic centre-Medical Centers where tests are done on clinical specimen or patient in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease. Laboratory /Imaging Studies/Non Imaging Diagnostic studies are included in these centers.

Public Interest– The Hon’ble Supreme Court in the matter of Bihar Public Service Commission v. Saiyed Hussain Abbas Rizwi: (2012) 13 SCC 61 while explaining the term “Public Interest” held:

“22. The expression “public interest” has to be understood in its true connotation so as to give complete meaning to the relevant provisions of the Act. The expression “public interest” must be viewed in its strict sense with all its exceptions so as to justify denial of a statutory exemption in terms of the Act. In its common parlance, the expression “public interest”, like “public purpose”, is not capable of any precise definition. It does not have a rigid meaning, is elastic and takes its colour from the statute in which it occurs, the concept varying with time and state of society and its needs (State of Bihar v. Kameshwar Singh([AIR 1952 SC 252]). It also means the general welfare of the public that warrants recognition and protection; something in which the public as a whole has a stake [Black’s Law Dictionary (8th Edn.)].”

In Mardia Chemical Limited v. Union of India (2004) 4 SCC 311, the Hon’ble Supreme Court of India while considering the validity of SARFAESI Act and recovery of non-performing assets by banks and financial institutions in India, recognised the significance of Public Interest and had held as under :
“………….Public interest has always been considered to be above the private interest. Interest of an individual may, to some extent, be affected but it cannot have the potential of taking over the public interest having an impact in the socio-economic drive of the country………..”

Minimum Standards

Indian Public Health Standards

National Rural Health Mission (NHM) was launched in the year 2005 to strengthen the Rural Public Health System and has since met many hopes and expectations. The Mission seeks to provide effective health care to the rural populace throughout the country with special focus on the States and Union Territories (UTs), which have weak public health indicators and/or weak infrastructure. Towards this end, the Indian Public Health Standards (IPHS) for Sub-centres, Primary Health Centres (PHCs), Community Health Centres (CHCs), Sub-District and District Hospitals were published in January/ February, 2007 and have been used as the reference point for public health care infrastructure planning and up-gradation in the States and UTs. IPHS are a set of uniform standards envisaged to improve the quality of health care delivery in the country. The IPHS documents have been revised keeping in view the changing protocols of the existing programmes and introduction of new programmes especially for Non-Communicable Diseases. Flexibility is allowed to suit the diverse needs of the States and regions. These IPHS guidelines will act as the main driver for continuous improvement in quality and serve as the bench mark for assessing the functional status of health facilities. States and UTs should adopt these IPHS guidelines for strengthening the Public Health Care Institutions and put in their best efforts to achieve high quality of health care across the country.[Ministry of Health Govt of India]

1. Sub Centers
2. Primay Health Centre
3. Community Health Centre
4. Sub-district & Sub-divisional Hospital
5. District Hospital

Allopathic

1. Health Check up Centre Speciality / Super-Speciality Specific
2. Integrated Counselling Centre
3. Dietetics
4. Hospital (Level 1)
5. Hospital(Level 2)
6. Hospital(Level 3)
7. Mobile Clinic Only Consultation
8. Mobile Clinic With Procedure
9. Mobile Dental Van
10. Dental Lab
11. Physiotherapy Centre
12. Clinic/Polyclinic Only Consultation
13. Clinic/Polyclinic With Diagnostic Support
14. Clinic/Polyclinic With Dispensary
15. Clinic/Polyclinic With Observation

AYUSH

1. Ayurveda
2. Homoeopathy
3. Naturopathy
4. Siddha
5. Sowa-Rigpa
6. Unani
7. YOGA

Standard Treatment Guidelines(Speciality/Super Speciality wise)

1. Guidelines for Cardiovascular Diseases

2. Guidelines for Critical Care

3. Guidelines for Gastroenterological Diseases

4. Guidelines for Obstetrics and Gynaecology

5. Guidelines for Haemodialysis

6. Guidelines for Ophthalmology

7. Guidelines for ENT

8. Guidelines for Orthopaedics

9. Guidelines for Medicine (Respiratory)

10. Guidelines for Medicine (Non Respiratory Medical Conditions)

11. Guidelines for Paediatrics and Paediatrics Surgery

12. Guidelines for General Surgery

13. Guidelines for Interventional Radiology

Health Care Service Costing OT

Operation Theatre (O.T):

Under Each Category the costs are segregated into Manpower costs, Machinery Costs, Material Cost and other Costs.

A- Operation Theatre

1. For all procedures STG are to be followed and accordingly the time to perform has to be considered for absorption of costs. For example it could be Standard O.T time for
CABG surgeries is taken as 8 hrs. This includes of preparation time of one hour, surgery time of 6 hours and cleaning time of one hour.
2. If there are more than one OT these costs are to be been taken based on number of surgeries or the surgery time wherever applicable.
3. O.T Man-power used for the specific surgery has been considered for Man-power cost. The cost has been appropriately absorbed when the same manpower is used for other procedures/surgeries.
4. Average life-time of O.T equipments can be considered as 7 years.
5. Scrap value of O.T equipments (Medical) and Non-Medical equipments can be taken as actual value
6. Annual Insurance of O.T equipments taken as actual cost.
7. Annual Repairs & Maintenance of O.T equipments taken as actual cost.
8. Depreciation & other maintenance cost for O.T equipments can be apportioned to different surgeries.
9. Non-Medical Asset cost can be apportioned to Surgeries/ Procedures in the ratio in which the surgery/procedure performed
10. Cost of building relating to O.T is apportioned based on the area occupied by O.T.
11. Life time of building can be considered as 30 years.

B- Pre & Post-operative Ward (POW):

1. Average life-time of Medical equipments in POW can be considered as 7 years.
2. Scrap value of Medical equipments and Non-Medical Assets in POW can be taken as actual value
3. Annual Repairs & Maintenance of Medical equipments in POW taken as actual cost.
4. Annual Insurance of Medical equipments in POW taken as actual cost.
5. Average life-time of Non-Medical Assets used in POW to be considered as 5 years.
6. Life time of building to be considered as 30 years.

List of Recognised Qualifications of person incharge of Clinical Establishments

ALLOPATHY MEDICAL DEGREES

GRADUATE
MBBS
PG DIPLOMA (WITH BASIC DEGREE AS MBBS) IN SPECIALTY/SUPER SPECIALTY
Diploma in Oto-Rhino-Laryngology
Diploma in Radio-Diagnosis
Diploma in Radio Therapy
Diploma in Medical Virology
Diploma in Occupational Health
Diploma in Ophthalmology
Diploma in Orthopaedics
Diploma in Public Health
Diploma in Physical Medicine and Rehabilitation
Diploma in Psychological Medicine
Diploma in Radiation Medicine
Diploma in Sports Medicine
Diploma in Tuberculosis and Chest Diseases
Diploma in Tropical Medicine Health
Diploma in Dermatology, Venereology and Leprosy
Diploma in Venereology
Diploma in Paediatrics
Diploma – Aviation Medicine
Diploma in Cardiology
Diploma in Basic Medical Sciences (Anatomy)
Diploma in Basic Medical Sciences (Physiology)
Diploma in Basic Medical Sciences (Pharmacology)
Diploma in Maternity and Child Welfare
Diploma -Diploma V and D
Diploma in Medical Radioligy and Electrology
Diploma – Diploma in Pathology and Bacteriology
Diploma in Microbiology
Diploma in Path. and Bact.
Diploma in Industrial Health
Diploma in Allergy and Clinical Immunology
Diploma in Anesthesia
Diploma in Child Health
Diploma in Community Medicine
Diploma in Clinical Pathology
Diploma in Dermatology
Diploma in Diabetology
Diploma in Forensic Medicine
Diploma in Health Administration
Diploma in Hospital Administration
Diploma in Health Education
Diploma in Immuno-Haematology and Blood Transfusion
Diploma in Leprosy
Diploma (Marine Medicine)

POST GRADUATE DEGREE (WITH BASIC DEGREE AS MBBS) IN SPECIALTY

MD – Tropical Medicine
MD – Maternity and Child Health
MD – CCM
MD – Sports Medicine
MD-Transfusion Medicine
MD – Immuno Haematology and Blood Transfusion
Master of Public Health (Epidemiology) With basic degree as MBBS
MD – Anaesthesiology
MD – Aviation Medicine
MD – Bio-Chemistry
MD – Bio-Physics
MD – Forensic Medicine/Forensic Medicine and Toxicology
MD – General Medicine
MD – Community Health Administration
MD – Geriatrics
MD – Hospital Administration
MD – Lab Medicine
MD – Microbiology
MD – Nuclear Medicine
MD – Obstetrtics and Gynaecology
MD – Paediatrics
MD – Dermatology , Venereology and Leprosy
MD – Pharmacology
MD – Physiology
MD – Physical Medicine and Rehabilitation
MD – Psychiatry
MD – Radiotherapy
MD – Social and Preventive Medicine / Community Medicine
MD – Venereology
MD – Pathology and Microbiology
MD – Emergency Medicine
MD – Family Medicine
MD – Radio Diagnosis/Radiology
MD – Aviation Medicine/Aerospace Medicine
MD – Rheumatology
MD – Palliative Medicine
MD/MS – Obstetrtics and Gynaecology
MS – Orthopaedics
MS – ENT
MS – General Surgery
MD/MS – Anatomy
MD/MS – Ophthalmology

• Master of Hospital Administration (with basic degree as MBBS)
• Master Degree in Applied Epidemiology (with basic degree as MBBS)
• Master of Public Health (with basic degree as MBBS)

SUPER SPECIALTY DEGREE DM, MCH (with basic degree as MBBS)

DM – Neurology
DM – Rheumatology
DM – Endocrinology
DM – Clinical Immunology
DM – Pul. Med. and Critical Care Med
DM – Cardiac-Anaes.
DM – Haematology Pathology/Hematopthology
DM – Medical Genetics
DM – Organ Transplant Anaesthesia and Critical Care
DM – Critical Care Medicine
DM – Paediatric Hepatology
DM – Paediatric Neurology
DM – Neuro Anaesthesia
DM – Paediatric Nephrology
DM – Reproductive Medicine
DM – Infectious Disease
DM – Paediatric Oncology
DM – Geriatric Mental Health
DM – Paediatric Critical Care
DM – Paediatric Haematology Oncology
DM – Paediatric and Neonatal Anaesthesia
DM – Clinical Pharmacology
DM – Clinical Haematology
DM – Pulmonary Medicine
DM – Neuro Radiology
DM – Nephrology
DM – Neonatology
DM – Oncology
DM – Gastroenterology
DM – Cardiology
DM – Infectious Diseases
DM – Hepatology
DM – Immunology
DM – Pediatrics Gastroenterology
DM – Pediatrics Cardiology

M.Ch – Endocrine Surgery
M.Ch. – Hand and Micro Surgery
M.Ch. – Hand Surgery
M.Ch. – Head and Neck Surgery
M.Ch – Vascular Surgery
M.Ch – Cardio Thoracic Surgery
M.Ch – Cardio Thoracic and Vascular Surgery
M.Ch – Neuro Surgery
M.Ch – Paediatric Surgery
M.Ch – Plastic Surgery
M.Ch – Surgical Gastroenterology/G.I. Surgery
M.Ch – Surgical Oncology
M.Ch – Thoracic Surgery
M.Ch – Hepato Pancreato Biliary Surgery
M.Ch – Urology/Genito-Urinary Surgery
M.Ch – Gynaecological Oncology
M.Ch – Pediatric Cardio-Thoracic Vascular Surgery
FCPS Fellowship of the College of Physicians and Surgeons (WITH BASIC DEGREE AS MBBS)
F.C.P.S.(Medicine)
F.C.P.S.(Pathology)
F.C.P.S.(Surgery)
F.C.P.S.(Mid. and Gynae)
F.C.P.S.(Ophthalmology)
PDCC Post-Doctoral Certificate Courses (WITH BASIC DEGREE AS MBBS)
PDCC – Gastro-Radiology
PDCC – Cardiac-Anaesthesia
PDCC – Neuro-Anaesthesia
PDCC – Organ Transplant Anaesthesia
PDCC – Paediatric Endocrinology
PDCC – Critical Care Medicine
PDCC – Paediatric Gastroenterology
PDCC – Laboratory Immunology
PDCC – Infectious Diseases
PDCC – Nuclear Nephrology
PDCC – Renal Pathology
PDCC – Neuro-Radiology
PDCC – Aphaeresis Technology and Blood Component Therapy
PDCC – Pain Management
PDCC – Haemato-Oncology
PDCC – Paediatric Endocrinology
PDCC – Paediatric ENT
PDCC – Interventional Radiology
PDCC – Spine Surgery

ALLOPATHY DENTAL DEGREES

GRADUATE
B. D. S.
POST GRADUATE DEGREE/DIPLOMA
MDS – Prosthodontics and Crown and Bridge
MDS – Periodontology
MDS – Oral and Maxillofacial Surgery
MDS – Conservative and Endodontics
MDS – Orthodontics and Dentofacial Orthopaedics
MDS – Oral Pathology and Microbiology and Forensic Odontology
MDS – Public Health Dentistry
MDS – Paediatric and Preventive Dentistry
MDS – Oral Medicine and Radiology
PG Diploma in Prosthodontics and Crown and Bridge
PG Diploma in Periodontology
PG Diploma in Oral and Maxillofacial Surgery
PG Diploma in Conservative and Endodontics
PG Diploma in Orthodontics and Dentofacial Orthopaedics
PG Diploma in Oral Pathology and Microbiology and Forensic Odontology
PG Diploma in Public Health Dentistry
PG Diploma in Paediatric and Preventive Dentistry
PG Diploma in Oral Medicine and Radiology

AYUSH DEGREES
GRADUATE
B.A.M.S
B.H.M.S
BNYS (Bachelor of Naturopathy and Yogic Sciences
B.S.M.S
BTMS (Bachelor in Tibetan Medical System or Amchi Chikitsa Acharya)
B.U.M.S
POST GRADUATE
M.D. (Ayurved)
M.D. (Homoeopathy)
M.D. (Unani Medicine)
M.D. (Siddha)
Any other AYUSH Degree (only if recognised by Central/State Govt/Regulatory Council)

FORMATS

1. Format Hospital Agreement with Government for Cashless treatment.
2. Application for Provisional Registration of Clinical Establishment