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How do I set up my accredited lab?  

1.      Determine your patient's needs and assess the laboratory's test menu and the selection of test methodologies; taking into consideration level of complexity of tests, cost effectiveness and test volume before implementation of new systems.

2.      Ensure that the Laboratory has a qualified Laboratory Director and Quality Manager who will be responsible for the overall operation and administration of the laboratory as per NABL guidelines.

3.      Apply for a NABL certificate by completing and submitting the NABL application (Form-153).

4.      Enroll in Proficiency Testing for all tests requiring PT enrollment .

5.      Perform validation of new methods , accuracy, precision, and reportable range for all applicable  analytes.

6.      Establish and implement a procedure manual.

7.      Establish and implement quality control and quality assurance programs.

8.      Specify in writing the responsibilities and duties of each testing person, ensuring all testing personnel are competent.

9.      The Laboratory must have a record system; Temperature logs, maintenance logs, master logs, specimen referral logs, reagent logs, action logs, communication logs, QC logs and patient test result logs.

10.  Follow NABL guidelines and good Laboratory Practices.

 

 

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