what registration and formalities are required to open a pathology lab??

Hey

A very basic (small size-less than 100 patients per day) lab setup will need the following :

1. Planning : Before starting off, its best to decide on the scope of the lab and the services it will provide which may include Hematology, Biochemistry, Clinical Pathology, Serology, Cytopathology, Histopathology etc. Based on this the space, technical requirements, their maintenance, number of qualified personnel, their salaries, monthly reagents needed, their expenditure, etc have to decided.
2. Lab infrastucture : This includes space for the waiting area,blood collection,lab equipment, processing ,examination,storage and waste disposal. In urban areas , most would prefer to rent a place rather than buy their own space. In smaller cities and towns , it may be feasible to purchase property.
3. Registration : Once the Planning phase is completed, you need to have legal identity in the form of a proprietorship, partnership or start a limited liability company. You need to get registered with the 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. These are the basic requirements. there may be more legal requirements based on the state you are in.
4. Staff: 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 etc full time or part time based on the lab workload to ensure quality reporting and minimize errors.
5. Technical requirements and Consumables : Based on the scope of the lab, you need a 3 or 5 part hematology analyser, a fully or semiautomated 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 may need specialised equiment . Some may choose to outsource such investigations. All equipments need maintenance and calibration schedules and need Standard operating procedures handy so that the technical staff can refer to them when needed.
6. 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.
7. Software: You require a lab management software that can generate bills/invoices, print reports and store data securely.

NABL 112 ( http://nabl-india.org/nabl/file_download.php?filename=201210170522-NABL-112-doc.pdf ) is a very helpful document that can guide those who are interested in improving the lab quality, even if they dont find it feasible to apply to Accreditation.

One should aim to provide high quality reports that can be depended upon for patient management.