Quality Assurance Program

“Continuous Efforts and Execution leads to quality excellence”

The term Quality Assurance Program (QAP) is seen as a powerful tool to help laboratories to demonstrate their competence in sample testing .QAP enables laboratories to monitor their accuracy and quality of results overtime, identify trends and help them to take necessary corrective action.

Scope

The scope of our work are:
  • ●   Individual Planning and execution of QAP in the field of Hematology, Biochemistry, Immunology, Histopathology & Cytopathology, Microbiology & Serology, Urine Analysis, Haemoglobin (HbA1c), SARS CoV2, ANA-IFA, MSM.
  • ●   The QAP team is proud to present India's first NABL ISO IEC 17043:2010 accredited SARS CoV2 program.
  • ●   Inviting medical laboratory to participate in the program.
  • ●   Preparation of proficiency testing item and conducting its homogeneity and its stability testing.
  • ●   Dispatching of PT item to the participant.
  • ●   Participant performance evaluation by statically design program.
  • ●   QAP has introduced a QAP for ANA-IFA in the year 2021. We have successfully completed the pilot program and now awaiting for accreditation.
  • ●   In the year 2022, the team is proud to present a new EQAS program for Maternal Screening Markers Offering; free β-HCG, AFP, PAPP-A, E3, and Inhibin-A in the scope.


Aim

QAP is design to monitoring laboratories continuing performance, identification of problems in lab and initiation of action for improvement. The program is evaluated the laboratory performance against the pre established criteria by mean of inter laboratory comparison.

  • ●   Improve the quality of analytical measurement of laboratory.
  • ●   Established the effectiveness and precision of testing method.
  • ●   Checking the individual testing performance.
  • ●   Developed confident the test result of laboratory.


Quality Objectives

  • ●   Maximum benefit of our service for our participant with highest possible quality.
  • ●   Achieve participant satisfaction by regular interaction and feedbacks.
  • ●   Striclly confidential treatment of all information obtained within scope of activity.
  • ●   Rise of our competence by intensive development of the quality of our services.


Benefits of QAP

Laboratories undertake external Quality assessment program (EQAS) as part of their quality system. Participantion in EQAs is a requirement of all laboratory accreditation standard such as the NABL ISO 15189:2012 Medical laboratories particular requirements for quality and competence standard against which most diagnostic laboratories are assessed.

Helps to increase the confidence in laboratory performance which is not essential for laboratories but also for their customers.

Organization Improved efficiency and effectivenessConsistency and continuous performance improvement
Staffs Define structure. Authority levels and responsibilities. Confident and empowered personnel
Customer Improved service meaning their need. Confidence in laboratory service.


General overview of the Company

The Research foundation which is registered under society in 2004 is sister concerned of M/s Mehrotra Pathology Pvt. Ltd. Which was established in 1954 as a humble effort to provide genuine help to the patients, by Prof. Mehrotra , MD PHD (London) F.R.C. Path, F.A.M.S. The organization realized the importance of correct diagnosis, which leads to proper management of the patients. As a mark of its commitment for accuracy, reproducibility, the organization has been performing test in accordance with ISO 15189 NABL (National Accreditation board for Testing & Calibration Laboratory), India from last 11 years.



Quality Assurance Program

The QAP is a yearly cycle which includes six samples in a year at two monthly interval starting February in the following area-

Fields

Frequency of samples

Months of dispatch

Basic Biochemistry, Extended Biochemistry, Immunology, Clinical Pathology

Twelve samples in a year

As per Plan details

Histopathology(Part A and Virtual), Microbiology & Basic Serology, , Hematology

Six samples in a year

As per Plan details

HbA1C, ANA-IFA

Four samples in a year

As per Plan details

Extended Serology, Sars CoV, Cytopathology Part A, Maternal Screening Markers(MSM)

Two samples in a year

As per Plan details

Cytopathology Virtual

Three samples in a year

As per Plan details



NABL Accreditation

In 2013 the Director proposed the accreditation of the QAP to confirm its competenc as a proficiency testing provider . Work began on documentation of its Quality system and accreditation to ISO/IEC 17043 :2010 conformity assessment- General requirement for profieciency tests. In year 2014 the QAP accreditation by NABL as pr ISO/IEC 17043:2010 international standard with certified number P-0009. QAP takes pride to only lab in india who is NABL accreditation in all the program and providing participant with world class, professional services. Characterised by the best possible material, data management system and reports. In addition the program provide professional support and consultation and undertaken variety of activities such as workshop and seminars.

*ISO/IEC 17043:2010 accrediated fields are as follows:

  • ●   Basic Biochemistry
  • ●   Extended Biochemistry
  • ●   Haematology
  • ●   Immunology
  • ●   Microbiology
  • ●   Basic Serology
  • ●   Extended Serology
  • ●   Histopathology  
  • ●   Cytopathology
  • ●   Urine Routine analysis
  • ●   SARS CoV2
  • ●   HbA1c
    *Program Awaiting accreditation
  • ●   ANA
    *New program launched in 2022 (Pilot Program)
  • ●   MSM
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Quality Assurance Program Process

This QAP belongs to the category of inter laboratory comparison schemes involving simultaneous Participation of laboratory in different area of city and states. Randomly selected PT item are being distributed simultaneously to the participants for concurrent testing. After the completion of the testing at Participants end, the results should be returned to the - QAP Provider (Research Foundation) in the prescribed formats. These results are compared with the group mean and SD derived from the participants' values of proficiency test item- PT Item (for quantitative tests) and consensus values (for qualitative test) to give an indication of the performance of the individual participants and of the group as a whole. This flow chart given below outline the whole process.

  • Enrollment of participant
  • Assigning Participant code to maintain confidentiality
  • Selection of PT (Proficiency Testing item
  • PT Item Homogeneity Study
  • Labeling & Packaging of PT item
  • Distribution to the participating labs
  • PT item Stability Study
  • Analysis by the participating Labs
  • Submission of the result the QAP
  • Analysis by the -QAP
  • Generating the performance report of participant lab
  • Distributing the Assessment report to participant lab
  • Distribution to End Cycle Analysis Report and Certificate of participation to the lab


QAP Assessment Report

  • ●   Easy to understand & interpret the results:
  • ●   Group wise mean of the participant’s results.
  • ●   Each laboratory receives an individual report pertaining to other laboratories performance.
  • ●   Data from all participating laboratories are analyzed to determining over all Group Mean & Standard Deviation.
  • ●   The difference between your test results and the overall average is expressed by standard deviation index.
  • ●   Report indicates your performance relative to the group.