Scope of Work
When starting a lab business, the most fundamental thing to decide is scope of the lab and the services it will provide. For a full-fledged lab, this may generally include Hematology, Biochemistry, Microbiology, Immunology, Serology, Histopathology, Cytopathology and more. However a small & medium Lab may have limited scope based on market potential. 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.
Lab infrastructure
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. Cost budgeting for all the above is necessary. You need to do space planning, whether the lab will be in rented or purchased premises. Assume for growth in business at least for the medium term of 3-5 years.
Location of the Lab, like any other business is very critical for its success. The Lab is best located near doctors clinics, hospitals and closer to residential area where maximum foot falls could be expected.
Statutory Compliance for Diagnostic Centre/ Lab
Once the Planning is over, it is time to register a legal business entity. Decide whether it will be a proprietorship, partnership, LLC or Private Limited company based on future plans and number of founders involved. Some of the basic statutory requirements could be:
- Registration under Shops and Establishments Act,
- Clinical Establishment Act if implemented in the state,
- Director of Health Services,
- Local Biomedical Waste disposal Body,
- Approval for waste generation from state pollution control board,
- Fire NOC,
- Municipal NOC.
- Check for more legal / statutory requirements based on the state you are in.
Diagnostic centre – Staff planning & hiring
You need to hire qualified technicians based on the number of hours the lab is operational. They need to be given basic induction training and continuous education to minimize human error and improve lab safety. Staff should be vaccinated against Hepatitis B and Tetanus. 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. In addition plan needs to be made for billing/ customer care, administrative, marketing as well as home collection staff, depending on the size of operations.
Equipment & Technical requirements
Based on the scope of the diagnostic centre/ diagnostic lab, you need a 3-part differential cell-counter or 5 part hematology analyser, a fully or semi-automated biochemistry analyser, controls for internal and external quality control, reagents for analysis and staining, consumables for blood collection, fridges, centrifuges, incubators, pipettes (regularly calibrated), autoclave for pre-treatment before waste disposal, stationery. Sections like microbiology and histopathology will need specialised equipment. You may choose to outsource such investigations that may not be inscope due to low volumes or high cost. In case of outsourcing, put in place a proper tie-up with a larger lab facility. All equipment need maintenance and calibration on regular basis. Put in place Standard operating procedures (SOPs) and train all staff on the same so that all processes are streamlined and followed.
Reagents and Consumables
You need to place order with different vendors after comparing the prices and based on the reagents/ consumables/controls and the company you decide to purchase from.
Lab Information Management System Software
All professional Labs need a basic lab management software that can generate bills/invoices, maintain inventory, print reports and store data securely.
NABL accreditation for Diagnostic centre
It is not easy to get and retain a NABL accreditation. It requires stringent quality processes within the organization. Whether you want to apply for NABL or just improve quality in the Lab the following document can be helpful. (http://nabl-india.org/nabl/file_download.php?filename=201210170522-NABL-112-doc.pdf ). NABL (National Accreditation Board for Laboratories) accreditation is a stamp of Quality approval for Laboratories in India.
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