Section 33 in West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules, 2017
33. Classification.
(1)The clinical establishments shall be classified depending upon the following criteria namely (a) Location of the clinical establishment as mentioned under rule 40; (b) System of Medicine practiced by the clinical establishment as mentioned under rule 32; (c) Service facilities offered by the clinical Establishment or (d) any other criteria as may be notified by the Government from time to time.(2)The service facilities offered by the clinical establishment shall be classified into following mutually exclusive categories which include: (a) Outpatient based Service Facilities; (b) Inpatient based service Facilities; (c) Pathology Laboratory service Facilities; (d) Diagnostic Imaging laboratory service Facilities.(3)Depending upon the nature of service sub-facilities offered, such Outpatient based Facilities mentioned in sub-rule (2), shall be further classified into following mutually exclusive sub-categories which include: (i) Solo clinic; (ii) Polyclinic; (iii) Dental Clinic; (iv) Refraction clinic; (v) Physiotherapy Clinic; (vi) Acupuncture clinic (vii) Occupational therapy Clinic; (viii) Counseling Centre; (ix) Wellness/Fitness centre/clinic; (x) any other clinic or OPD based service centre as may be notified.(4)Depending upon the nature of sub-facilities offered, such Inpatient based Facilities mentioned in sub-rule (2) shall be further classified into following mutually exclusive sub-categories which include: (i) Infertility Clinic; (ii) Dialysis Centre; (iii) Medical Termination of Pregnancy (MTP) clinic; (iv) any such other Day care centre as may be notified; (v) Maternity Home; (vi) Nursing Home/Hospital/Sanatorium; or (vii) Any such other IPD based service centre as may be notified.(5)Depending upon the nature of sub-facilities offered, such Pathology Laboratory Facilities mentioned in sub-rule (2) shall be further classified into mutually exclusive sub-categories which include: (i) Collection centre; (ii) Small Laboratory; (iii) Medium Laboratory; (iv) Large Laboratory; (v) Genetic Laboratory; (vi) any such other pathology laboratory as may be notified.Explanation 1. - The term '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.Explanation 2. - The term '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.Explanation 3. - The term '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.Explanation 4. - The term '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. However Large Labs doing investigations by Radio-immunoassay technique need clearance from BARC.Explanation 5. - "genetic laboratory" means a laboratory as defined under the Pre-conception and Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994.(6)Depending upon the nature of sub-facilities offered, such Diagnostic Imaging laboratory Facilities as mentioned in sub-rule (2) shall be further classified into mutually exclusive sub-categories which include: (i) X-Ray laboratory (Conventional) (ii) X-Ray laboratory (Digital); (iii)Mamography laboratory; (iv) Bone Densitometry laboratory; (v) Ultrasonography laboratory; (vi) Colour Doppler Imaging laboratory; (vii) CT Scan laboratory; (viii) Magnetic Resonance Imaging (MRI) laboratory; (ix)Positron Emission Tomography (PET) Scan laboratory; (x) Echo-cardiocraphy laboratory; (xi) Electro-cardiography laboratory; (xii) Electro-encephalography laboratory; (xiii) Electromyography laboratory; (xiv) Audiometry lab; or (xv) Other Clinical Physiological test laboratory or (xvi) Any such other Imaging laboratory as may be notifiedExplanation. - 'Other Clinical Physiology' shall include (i) Heart function tests; (ii) Blood volume estimation; (iii) Lung Function tests & spirometry; (iv) Estimation of basal metabolism.(7)Services provided by the Pathology laboratory shall include (a) Morphological Pathology; (b) Clinical Pathology/ biochemistry; (c) Microbiology; and (d) Haematology.Explanation 1. - 'Morphological Pathology' shall include: (i) Histopathology and histochemistry; and (ii) Exfoliative cytology except Morbid anatomy (autopsy);Explanation 2. - 'Clinical Pathology'/'biochemistry' shall include (i) Estimation of carbohydrate, lipid protein and electrolyte constituents of blood, urine and other body fluids, and their metabolites; (ii) Determination of endocrine levels and enzyme reactions; and (iii) Levels of drugs and toxic substances etc.Explanation 3. - 'Microbiology' shall include (i) Bacteriology; (ii) Parasitology; (iii) Mycology; (iv) Virology; and (v) Immunology;Explanation 4. - 'Haematology' shall include (i) the study of blood, bone marrow, the reticulo-endothelial system, and those disease associated with alterations of its cytological constituents; (ii) The study of the physico-chemical features associated with haemorrhages and blood dyscrasias; (iii) Immuno-haematology; and (iv) Laboratory procedures associated with blood transfusion.(8)Irrespective of types and numbers of service sub-facilities officered as mentioned in sub-rule (3) to (6), the clinical establishment shall be classified into following categories depending upon the number of service facilities offered as mentioned in sub-rule (2): (a) Uni-facility clinical establishment offering only one type of service facility or (b) multifacility clinical establishment offering more than one type of service facility.Illustration 1. A clinical establishment offering only X-Ray laboratory (Digital) service shall be classified as Uni-facility clinical establishment (Diagnostic imaging)Illustration 2. A clinical establishment offering X-Ray laboratory (Digital) service and USG shall be classified as Unifacility clinical establishment (Diagnostic imaging).Illustration 3. A clinical establishment offering any type of Diagnostic imaging service and along with any type of OPD clinic service shall be classified as Multi-facility clinical establishment.Illustration 4. A clinical establishment offering any type of OPD clinic service and along with any type of IPD facility shall be classified as Multi-facility clinical establishment.
