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1. Background and Overview of Process
The Zimbabwe National Quality Assurance Programme (ZINQAP) Trust provides a
comprehensive External Quality Assurance (EQA) Programme including an accredited
Proficiency Testing (PT) Service for laboratories and testing sites. The purpose of PT is to
provide participants (laboratories and testing sites) with an objective means of measuring
the quality of the testing services that they provide. ZINQAP operates from Parirenyatwa
Hospital Grounds Mazowe Street, Harare, and Zimbabwe and provides PT in all the major
disciplines of laboratory medicine. (Refer to Appendix 1: List PT Schemes). ZINQAP carries
out the following activities in running the PT Programme:
Develop a PT Plan and Calendar
Prepare PT samples
Examine the PT samples prior to shipment
Dispatch the PT shipment
Receive participant data
Analyse the data received
Prepare and distribute performance report
ZINQAP prepares and distributes an annual PT calendar detailing the various shipment dates
and target dates, by which all data needs to be submitted to ZINQAP. ZINQAP also prepares
and distributes a price list, detailing the cost of enrolling in each of the PT schemes. To
provide information on the operation of the schemes, ZINQAP has scheme protocols for all
the schemes, detailing how each scheme works. The scheme protocols are distributed to all
1.2 Participation in the PT Scheme
PT Scheme participants who include medical laboratories and testing sites register by
filling in, signing and returning the registration form to confirm that they will abide
by the Conditions of Participation as detailed in the PT Scheme Protocol.
Participants have two registration options:
1.2.1 Joining one or more Schemes for the full number of distributions.
1.2.2 Joining one or more Schemes for a limited number of distributions.
When a laboratory registers with the PT Programme, it is allocated a single primary
participant identification code. This identification code is used to identify the
laboratory at all times.
1.3 Participant Confidentiality
Participant confidentiality is of paramount importance. All participant information is
kept confidential at all times, except when the participant has waived confidentiality,
in line with ISO 17043 requirements for confidentiality. Only the individual
participant and authorised ZINQAP staff have access to participant laboratory
performance data and tests results.
2.1 System Environment
The System shall support Client Server Architecture; computers on the Local Area
Network (LAN) shall connect such that users may access System functions and data
from appropriate terminal devices connected to the LAN.
The System must be menu driven and comprise of a suitable database management
System that will be installed on a server. The database shall be built on Microsoft
Access or SQL (Structured Query Language). All the tables of the System shall be
inter-linked together so that data can be updated. This shall include links between
the participating tables, kit information, user table, PT agency table, distribution
table, evaluation table, response table, report table and online help facility. The
System shall allow staff to query and display all codes (e.g. participating test result
codes) relevant to the screen on which they are working.
The System shall incorporate and support desktop tools that allow easy structured
querying, analysis graphical reporting of any System data by users. No special
knowledge or experience of programing should be required.
The system shall be able to collate and perform robust statistical calculations in line
with the requirements of ISO17043.