Quality Assurance

The entire laboratory works towards the unannounced motto - "Perfection in Patient care".

In a city with innumerable diagnostic centers, we have made quality our top differentiator.

Quality assurance is maintained by monitoring all its aspects, viz. control of pre-analytical errors, analytical errors, post-analytical errors, turn-around time, maintenance of equipment, selection of reagents, standardisation of tests before they are introduced and external quality control assessment. We have an ongoing training programme for the technical staff.

We have distinct method performance specifications like sensitivity, precision, interferences, reference ranges, repeatability, reproducibility and linearity. Data on these are provided by manufacturers kit inserts.

Quality Control

The Quality Control program for each test method is evaluated so that:

• Manufacturers written instructions for operation are followed and recommendations for maintenance are implemented and documented.
• A procedure manual is readily available to the laboratory staff at all times.
• QC samples are analysed as specified in the procedure manual and results are documented each day of testing.
• Testing personnel have taken appropriate corrective action when calibration and control values are out of the acceptable range.
• Patient results are not reported unless QC results are within acceptable limits.

Calibrations

Calibration of equipment is done by a biomedical engineer (from equipment manufacturer) at times of installation and major breakdown.

Reagent and equipment measuring system calibration is done regularly according to the frequency suggested by the manufacturer.

Reagents

Approved (CE, FDA) reagents are used within the prescribed expiry period and stored under prescribed temperature conditions. Calibrators and quality control sera are reconstituted, stored and used according to prescribed norms; and records are maintained of the same.

Refrigerators, incubators, cold storage (kits and specimens stored) and deep freezers are checked daily for temperature and recording.

Personnel

Trained qualified personnel perform the tests, as per defined Standard Operating Procedures. The Chief Pathologist or designee reviews the performance of each employee working in the lab to assure employee competency. The written result of the review is stored in the individuals personnel file along with opportunities for continuing education.

Proficiency Testing (PT)

Results are reviewed by the section manager. Any unacceptable, unsatisfactory or unsuccessful result is carefully evaluated to identify the cause of the failure. The necessary corrective action is taken and re-evaluated upon completion of the next PT challenge. All information is documented and saved for at least two years.

Proficiency Testing Programmes :

Upcoming Endeavors Towards Quality Assurance :

Neotia Diagnostics Centre has already applied for accreditation by National Accreditation Board for Testing and Calibration Laboratories (NABL).

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India. It has been established with the objective to provide Government, Industry Associations, Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories.

NABL maintains its linkages with the international bodies like International Laboratory Accreditation Co-operation (ILAC) and Asia Pacific Laboratory Accreditation Co-operation (APLAC).

NABL accreditation is a formal recognition of the technical competence of a testing or calibration laboratory for a specific task, which is based on third party assessment. NABL accredited laboratories emerge as a member of global family of accredited laboratories.

Benefits of Accreditation

Formal recognition of competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:

• Potential increase in business due to enhanced customer confidence and satisfaction.
• Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.
• Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent.
• Increase of confidence in testing / calibration data and personnel performing work.
• Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories.
• Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
• Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results.