Minimum Standard of Medical Diagnostic Laboratories: Union Government notifies Clinical Establishment Rules
New Delhi: The Union Health Ministry has recent issued the revised Gazette notification, notifying the Clinical Establishments (Central Government) Amendment Rules, 2018 which lay down that 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."
Medical Diagnostic Laboratories (or Pathological Laboratories) have been divided into Basic Composite (Small), Medium and Advanced. The Gazette specifies the various tests which are either essential or desired to be conducted at the said laboratories as well as the infrastructure, legal, record keeping and manpower essential for various classifications on the laboratories
The schedule attached below lays down the requirement for each type of path labs.
Scope of Services
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 locations also. at field | 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. |
Infrastructure
Advanced
II | INFRASTRUCTURE | ||||
Basic Composite | Medium | ||||
1. Signage | |||||
(a) Basic signage- A 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 provided Haematology, Biochemistry, Pathology, Cytology, Genetics- whichever is applicable services i.e. Clinical Histology, Molecular | 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 segregated in coloured bins and bags as per Biomedical Waste Management Rules, 2016 including materials, chemicals, agents, biological material. waste radioactive toxic microbial infected | 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 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 | Not required | ||
(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 | ||
HUMAN RESOURCE
| (a) Minimum qualification of Technical Head of Laboratory or Specialist or *Authorised Signatories. *The authorised the signatory will be liable for the 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) the 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 a 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 BioChemistry and Microbiology 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) Microbiology respectively. (ii) Biopsies or Cytology specimens has to be reported by a person possessing a 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 BioChemistry and Microbiology shall be reported by Doctor of Medicine (MD) or Diplomate of National Board (DNB) BioChemistry and Doctor of Medicine (MD) or Diplomate of National Board (DNB) Microbiology 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 Microbiology 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 checkups and vaccination of staff | Essential: 1 | Essential: 1 | Essential: 2 |
INSTRUMENTS OR EQUIPMENT OR DRUGS
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 | |
LEGAL OR STATUTORY REQUIREMENTS
V | LEGAL OR STATUTORY REQUIREMENTS | |||
Legal or statutory requirements such as under the registration 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 | |
RECORD MAINTANENCE AND REPORTING
VI | RECORD MAINTANENCE 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) A vailability 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 | |
STANDARDS ON BASIC PROCESSES
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 | ||
Corrigendum: The article initially misinterpreted the gazette notification on the Human requirements. The article has since been corrected to include the correct interpretation. Medical Dialogues team apologises for the inconvenience.
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