You need a competent qualified signatory according to the NABL guidelines or as stated in the Clinical establishment act like a MD Pathologist/MD Microbiologist, full time or part time based on the lab workload to ensure quality reporting. Staff should be vaccinated against Hepatitis B and Tetanus. They need to be given basic induction training and continuous education to minimize human error and improve lab safety. You need to hire qualified technicians based on the number of hours the lab is operational. Check for more legal / statutory requirements based on the state you are in.ĭiagnostic centre – Staff planning & hiring.Approval for waste generation from state pollution control board,.Clinical Establishment Act if implemented in the state,.Registration under Shops and Establishments Act,.Some of the basic statutory requirements could be: Decide whether it will be a proprietorship, partnership, LLC or Private Limited company based on future plans and number of founders involved. Once the Planning is over, it is time to register a legal business entity. Statutory Compliance for Diagnostic Centre/ Lab The Lab is best located near doctors clinics, hospitals and closer to residential area where maximum foot falls could be expected. Location of the Lab, like any other business is very critical for its success. Assume for growth in business at least for the medium term of 3-5 years. You need to do space planning, whether the lab will be in rented or purchased premises. Cost budgeting for all the above is necessary. The Diagnostic centre infrastructure includes the lab premises (whether rented or owned), equipment, miscellaneous equipment like computers, barcode scanners, UPS, lab furniture, vehicles, collection devices and other, space for the waiting area, blood collection, examination, processing, storage, waste disposal, washrooms and staff area. Review the hospital and physician profile in the locality, what diseases are they treating and what sort of lab tests are they likely to prescribe? What is the expected patient volume for each type of investigation on a daily/monthly/Yearly basis? Answers to these questions will help decide the Lab Infrastructure including equipment. However a small & medium Lab may have limited scope based on market potential. For a full-fledged lab, this may generally include Hematology, Biochemistry, Microbiology, Immunology, Serology, Histopathology, Cytopathology and more. When starting a lab business, the most fundamental thing to decide is scope of the lab and the services it will provide. When setting up a medical diagnostic centre, it might be useful to consider the following aspects like Scope of Work planned in the Lab, Diagnostic Lab equipment list, legal & statutory compliance requirements, staffing and infrastructure planning and others. Are you planning to start a diagnostic lab or diagnostic centre? If yes, you may be wondering how to go about it.
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