Preamble - CLINICAL ESTABLISHMENTS (CENTRAL GOVERNMENT) AMENDMENT RULES, 2018 CLINICAL ESTABLISHMENTS (CENTRAL GOVERNMENT) AMENDMENT RULES, 2018 PREAMBLE Whereas the draft of certain rules to amend the Clinical Establishments (Central Government) Rules, 2012 was published, as required under section 52 of the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010), in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide notification of the Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, number G.S.R. 441(E), dated the 5th May, 2017 inviting objections and suggestions from all persons likely to be affected thereby; And whereas objections and suggestions received from the public have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 52 of the said Act, the Central Government hereby makes the following rules further to amend the Clinical Establishments (Central Government) Rules, 2012, namely:- (1) These rules may be called the Clinical Establishments (Central Government) Amendment Rules, 2018. (2) They shall come into force on the date of their publication in the Official Gazette. In the Clinical Establishments (Central Government) Rules, 2012, (hereinafter referred to as the said rules), in rule 2, after clause (b), the following clause shall be inserted, namely.- '(bb) "Schedule" means the Schedule appended to these rules'. In the said rules, after rule 8, the following rule shall be inserted, namely:- "8A. Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) - Every clinical establishment relating to diagnosis or treatment of diseases, where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Schedule." In the said rules, after rule 9, the following Schedule shall be inserted, namely:- SCHEDULE S. No. Type of Laboratory Basic Composite Medium Advanced (1) (2) (3) (4) (5) I Scope of Services These tests (as mentioned below) can be performed in mobile laboratory at field locations also. In addition to the tests performed in basic composite laboratory, including tests mentioned as under. In addition to tests performed in medium laboratory, additional tests mentioned as under. (a) Biochemistry Routine Biochemistry tests like Blood Sugar, Renal Function Tests, Liver Function Tests, Amylase, Lipase, Lipid profile, Cerebro -Spinal Fluid (CSF) and other biological fluids (glucose and protein), Oral Glucose Tolerance Test, Electrolytes, Calcium or Phosphate, HbA1c, any bio chemistry based rapid test. Hormone Bioassay, Tumor markers, plasma protein electrophoresis (a) coagulation profile, Drug monitoring and toxicology assay, (b) Molecular genetics, tests for detection of inborn errors of metabolism (b) Haematology Haemogram, Bleeding Time, Clotting Time, Prothrombin Time, Activated Partial Thromboplastin Time, Blood grouping and matching. Coagulation Assay All other Haematology tests also. (c) Histopathology Nil May do, subject to availability of equipment and specialist Histopathology Examination (d) Molecular Genetics Nil May do, subject to availability of equipment and specialist Molecular genetics (e) Cytopathology Nil PAP smear, Fine Needle Aspiration Cytology(FNAC), sputum and CSF cytology Immuno Cytochemistry. Other biological fluid cytology; Ultrasound or CT guided FNAC. (f) Immuno- histopathology Nil Nil Immunohisto-chemistry: (g) Medical Microbiology & Immunology Basic tests like Rapid Test (Point of Care tests) for infection, urine routine examination and microscopy, Hanging drop for Vibrio cholerae, Stool for ova, cyst. All HIV positive rapid assays need to be confirmed from the next level diagnostic laboratory. (a) Serological tests for viruses, bacteria, fungi, parasites (b) Cultural Sensitivity tests: Bacterial or fungal (c) Other special stains besides Gram's stain. (a) Culture sensitivity tests for viruses. (b) Real Time Polymerase Chain Reaction (RTPCR) tests. (c) Tissue diagnosis test for infectious diseases. II INFRASTRUCTURE Basic Composite Medium Advanced 1. Signage (a) Basic signage- A (b) signage within or outside the facility should be made available containing the following information. Essential Essential Essential (b) Name of the person-in-charge with qualification and registration number Essential Essential Essential (c) Broad services provided i.e. Haematology, Biochemistry, Clinical Pathology, Histology, Cytology, Molecular Genetics- whichever is applicable Essential Essential Essential (d) Timings of the different consultants Desirable Essential Essential (e) Internet facility or Telephone and mobile number for appointment Desirable Desirable Desirable (f) Fee structure: To be displayed separately including type of investigation and charges i.e., Special and routine tests Essential Essential Essential 2. Safety Signage (Wherever applicable) (a) Safety hazard and caution signs - Biomedical waste segregated in coloured bins and bags as per Biomedical Waste Management Rules, 2016 including radioactive materials, toxic chemicals, microbial agents, infected biological material. Essential Essential Essential (b) Appropriate Fire exit signages - Minimum one fire extinguisher Desirable Desirable Essential 3. Space requirement (a) Registration and waiting room, public utilities, safe drinking water etc. Desirable Essential Essential (b) Sample collection area Essential Essential Essential (c) Laboratory with adequate diffuse and spot lighting Essential Essential Essential (d) Toilet Essential Essential Essential (e) Reporting and billing area Essential Essential Essential (f) Staff room and doctor's duty room - Male and female different where 24 hours services available Desirable Desirable Essential (g) Washing room Essential Essential Essential (h) Preservation of the specimens and slides Essential Essential Essential (i) Electrical facilities Essential Essential Essential (j) Temperature control (o) for specialized equipment like flow cytometry and chemiluminescence equipment, ELISA test equipment etc. Essential Essential Essential (k) Counselling room for HIV Essential, if HIV test is done Essential, if HIV test is done Essential, if HIV test is done (l) FNAC room for all patients for sample collection Desirable Desirable Desirable (m) Dark room for Immuno-fluorescence Not required Not required Essential (n) Frozen Section facilities Not applicable Essential Essential 4. Furniture and fixtures Essential Essential as per scope of services Essential as per scope of services 5. Communication system - Telephone and mobile number for appointment Desirable Desirable Desirable 6. Wash Basins Essential Essential Essential III HUMAN RESOURCE (a) Minimum qualification of Technical Head of Laboratory or Specialist or *Authorised Signatories. *The authorised signatory will be liable for authenticity of the laboratory test report. Desirable: Bachelor of Medicine and Bachelor of Surgery (MBBS) from a recognised university institution. **Where ever interpretation of lab results or opinion there on are required, registered Bachelor of Medicine and Bachelor of Surgery (MBBS) medical practitioner is essential. Essential: Doctor of Medicine (MD) or Diplomate of National Board (DNB) in Pathology or Biochemistry or Medical Microbiology or Laboratory Medicine or Diploma in Clinical Pathology (DCP) or Bachelor of Medicine and Bachelor of Surgery (MBBS) with Doctor of Philosophy (PhD) in any of the subjects above. Desirable: If any special test of other speciality is done, it is desirable that specialist of that subject needs be there on full time or part time or outsourced basis. *Special tests means any other apart from routine basic biochemistry, haematology, or medical microbiology tests as listed in basic composite laboratory. Illustration: (i) Special Tests pertaining to Bio-Chemistry and Micro-biology shall be reported by Doctor of Medicine (MD) or Diplomate of National Board (DNB) Bio-Chemistry and Doctor of Medicine (MD) or Diplomate of National Board (DNB) Micro-biology respectively. (ii) Biopsies or Cytology specimens has to be reported by a person possessing Doctor of Medicine (MD) or Diplomate of National Board (DNB) Pathology. Essential: Doctor of Medicine (MD) or Diplomate of National Board (DNB) in Pathology or Biochemistry or Medical Microbiology or Laboratory Medicine or Diploma in Clinical Pathology (DCP) or Bachelor of Medicine and Bachelor of Surgery (MBBS) with Doctor of Philosophy (PhD) in any of the subjects above. Desirable: If any special test of other speciality is done, it is desirable that specialist of that subject needs be there on full time or part time or outsourced basis. *Special tests means any other apart from routine basic biochemistry, haematology, or medical microbiology tests as listed in basic composite laboratory. Illustration: (i) Special Tests pertaining to Bio-Chemistry and Micro-biology shall be reported by Doctor of Medicine (MD) or Diplomate of National Board (DNB) Bio-Chemistry and Doctor of Medicine (MD) or Diplomate of National Board (DNB) Micro-biology respectively. (ii) Biopsies or Cytology specimens has to be reported by a person possessing Doctor of Medicine (MD) or Diplomate of National Board (DNB) Pathology. (b) Number of laboratory technicians with Diploma in Medical Laboratory Technology (DMLT) or Bachelor of Science (BSc.) Medical Laboratory Technology (MLT) or Master of Science (M.Sc.) Bio-chemistry or Micro-biology qualification from a recognised university or institution. Essential: 1 Essential: 2 Essential: 4 (c) Support staff (Laboratory Assistant or Laboratory Attendant) Roster of salary of staff, Periodic health check-ups and vaccination of staff Essential: 1 Essential: 1 Essential: 2 IV INSTRUMENTS OR EQUIPMENT OR DRUGS (a) List of minimum medical diagnostics laboratory equipment with quantity Essential as per scope of services Essential as per scope of services Essential as per scope of services (b) List of minimum medical diagnostics laboratory instruments with quantity Essential as per scope of services Essential as per scope of services Essential as per scope of services (c) Sterilisation such as hot air oven or autoclave Essential Essential Essential (d) List of reagents and consumables required Essential Essential Essential (e) List of Disposables Essential Essential Essential (f) Policy of annual maintenance contract or comprehensive maintenance contract and records for equipment (Log books) Desirable Desirable Desirable V LEGAL OR STATUTORY REQUIREMENTS Legal or statutory requirements such as registration under the provisions of Biomedical Waste Management Rules, 2016 with State or Union territories' Pollution Control Board with registration number and date of expiry, site, space, location and environmental requirements to be as per local bye- laws Essential Essential Essential VI RECORD MAINTENANCE AND REPORTING (a) Reports of all patients date wise and specialty wise for example: Histopathology, Cytology, Haematology and Laboratory Medicine. Essential (Clinical Establishment to maintain information and statistics provided) Essential (Clinical Establishment to maintain information and statistics provided) Essential (Clinical Establishment to maintain information and statistics provided) (b) Medico legal records, if applicable (as per relevant law) Essential Essential Essential (c) Record keeping of technicians working in laboratory indicating their details of qualification training and others Essential Essential Essential (d) Availability of reference library including books or periodicals or e-journals or Compact Disc (CD)s Desirable Desirable Desirable (e) Duration of preservation of record (as applicable from time to time) Essential Essential Essential VII STANDARDS ON BASIC PROCESSES (a) Infection Control practices - as per Bio Medical Waste Management Rules, 2016 Essential Essential Essential (b) Safety considerations- use of disposable needles etc Essential Essential Essential (c) Patient Information and Education Essential Essential Essential (d) Process of calibration of equipment and reagents Essential Essential Essential (e) Booklet of Standard operating procedures of all procedures available Essential Essential Essential (f) Grievance registration and disposal mechanism Essential Essential Essential (g) Quality Control in the form of external quality assurance scheme or inter-laboratory comparison, as the case may be Desirable Desirable Desirable (h) Policy of proficiency testing of tests performed. Desirable Desirable Desirable
Rule 1 - RULE 1
Rule 2 - RULE 2
Rule 3 - RULE 3
Rule 4 - RULE 4
