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This document describes Sanofi Pasteur's external quality assessment (EQA) procedures. It outlines the providers and schedules for proficiency testing panels, the testing process, and review of results. Key responsibilities are assigned for developing the EQA schedule, performing testing, reviewing results, and monitoring data. If unsatisfactory results are found, corrective actions are taken and documented. Ungraded proficiency tests are also investigated by comparing results to peer responses. The goal is to ensure staff competency, test accuracy, and proper performance of reagents through regular participation in EQA programs.

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681 views4 pages

Page 1 of 4 Effective Date

This document describes Sanofi Pasteur's external quality assessment (EQA) procedures. It outlines the providers and schedules for proficiency testing panels, the testing process, and review of results. Key responsibilities are assigned for developing the EQA schedule, performing testing, reviewing results, and monitoring data. If unsatisfactory results are found, corrective actions are taken and documented. Ungraded proficiency tests are also investigated by comparing results to peer responses. The goal is to ensure staff competency, test accuracy, and proper performance of reagents through regular participation in EQA programs.

Uploaded by

akello
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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SANOFI PASTEUR

Title: External Quality Assessment

SOP ID#:
Effective Date: Version #: Supersedes version #:

Reviewed By Signature Date

1.0 Purpose
1.1 This SOP describes the steps followed in testing of proficiency samples, proficiency samples
help to check staff competency, accuracy of the equipment and performance of reagents or
test kits used.
2.0 Abbreviation list
2.1 CAPA- Corrective Action and Preventive Action
2.2 CBC - Complete Blood Count
2.3 EQA – External Quality Assessment
2.4 LFT - Liver Function Test
2.5 LM – Laboratory Manager
2.6 LT - Laboratory Technician/Technologist
2.7 PT – Proficiency Test
2.8 QM – Quality Manager
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2.9 QO – Quality Officer


2.10 UKNEQAS - United Kingdom National External Quality Assurance System

3.0 Tasks, responsibilities, and accountabilities


Tasks Person responsible Person accountable
Developing and pinning of EQA schedule QM LM
Performance of EQA LT QM
Results review LT/QO QM
Monitoring EQA and QC data QM LM
Trouble shooting LT, QM LM

4.0 Safety and environment


Handle all specimens and materials as capable of transmitting infections All EQA panels are
handled as per the provider’s recommendations.

5.0 Procedure
5.1 PT panels providers and schedule
5.1.1 Proficiency samples are received from UKNEQAS, Biorad, and RIQAS.
5.1.2 UKNEQAS provides complete blood count (CBC) provides panels on a quarterly basis.
5.1.3 Biorad provide chemistry panels for liver (LFT) and renal (RFT) function tests on the
monthly basis.
5.1.4 RIQAS is the provider of Urinalysis and Urine HCG proficiency test panels, these are
received once in two months.

5.2 Proficiency Testing Procedure


5.2.1 Samples are received by any laboratory technical staff who verifies them against the
accompanied paper inserts or instructions.
5.2.2 They are then forwarded to the responsible Laboratory personnel in the section to carry
out the testing.
5.2.3 Package is opened: integrity and temperature condition (room or refrigeration
temperature) of specimens are noted.
5.2.4 Package and / or paperwork contained within shipment is labeled with:
5.2.4.1. Time received
5.2.4.2. Date received
5.2.4.3. Initials for the person receiving.
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5.2.5 The Panels are then immediately stored at temperature recommended by the provider
until testing.
5.2.6 Meanwhile the accompanying documentation is kept within the section in which testing
is to be done.
5.2.7 Receiver of package notifies the Laboratory management including the respective section
head IMMEDIATELY of receipt of the panels either verbally or by email.
5.2.8 PT samples that require special preparation are prepared following the PT Provider’s
instructions that come along with the PT samples.
5.2.9 Proficiency samples are tested in the same manner as any routine specimen submitted to
the laboratory following test specific SOPs.
5.2.10 Testing is performed by staff who routinely analyzes the respective patient samples.
5.2.11 Under no circumstances does RHSP laboratory communicate with other participants,
refer, or accept referrals of PT samples to or from other laboratories.
5.2.12 The PT results (raw data) are recorded in respective registers or worksheets where
applicable.
5.2.13 The PT results are submitted either electronically or by hard copy depending on panels
provider’s preference and recommendation.
5.2.14 Raw data is kept on file in the specific sections/Quality office for any future reference.
5.2.15 When the survey results are returned, the respective testing technician and the Quality
officer sit to review the results.
5.2.16 If there are any unsatisfactory results, the immediate action is to retest the failed
parameter using the stored PT samples to compare the results with the peer mean and a
responsible LT investigates the problem and comes up with appropriate corrective and /
or preventive actions.
5.2.17 A copy of the findings from the investigations (CAPA forms) are attached to the EQA
results and the original CAPA form is filed in the General Occurrence management file.
5.2.18 The EQA samples are discarded upon reception of the next panels or after retesting for
the failed parameter.
5.2.19 Lab management may decide to use selected EQA samples to assess competency of staff
and for preparation of Internal Quality Control materials.

5.3 Handling Ungraded Proficiency Testing


5.3.1 For any ungraded proficiency testing, documentation is maintained on file to the above
effect. This could be due to late submission of results after the cut-off date, incorrect
completion of results of the result forms, lack of consensus and the laboratory being unable
to analyze or submit results.
5.3.2 Once the participant summary/final critique report for the survey is available, the
laboratory results for the ungraded test events are compared with the summary of referee
and participant responses. A computed report is filed showing agreement or disagreement

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with the other participating laboratories. For any unacceptable results, an investigation and
Corrective action is performed and documented.

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