Control of records includes the security of the electronic records, accessibility of records, the uniqueness and traceability of records and control of modification and validity of records.
Notes
2.13.1
Security of Records - Database and backup of data.
The management of the database is the responsibility of the ISP. The entire database is backed up daily ( each evening ~11.0opm EST. This means that data submitted after this time is not backed up until the following evening even though some participants have entered the data in their own time which may be after EST.
Updated: 22/10/2012
2.13.2
Accessibility of records.
Since QAPOnline is online, access to previous records is maintained. Currently, access to the original EQA data from 2003 remains open but access to submit replies to previous schemes is limited. Data Master files are updated at all times. From 2012, the Master file will not be updated for any reply submitted after 12 months from when the release was made public.
Updated: 22/10/2012
2.13.3
Data intergrity
As mentioned above, each record has a tag linking the reply to the quiz/release, the participant, the current company and laboratory links. The data for the key question is copied and maintained as a backup in a separate file.
Updated: 22/10/2012
2.13.4
Dynamic Nature of QAPonline.
A key feature of QAPonline is the dynamic nature of the submission and review process. Unlike other proficiency schemes that are sample based, QAPonline is largely image based and submission are available to review dynamically at the time the submission is made. This has advantages and disadvantages.
Updated: 22/10/2012
2.13.5
Advantages of dynamic Access.
A key advantage of dynamic data entry allows for staff to contribute to the data pool, permitting staff competency while still being actively employed. Having no time limitations encourages staff to catch up and remain current.
Updated: 22/10/2012
2.13.6
Disadvantages of dynamic access.
Clearly, the disadvantage of dynamic access is that the data is never fixed and finalised. QAPonline has set time limits not on when data may be submitted but when the master files are updated. In this way, new participants may still have access to QAPonline EQA Schemes but summary tables and reporting are fixed.
Updated: 22/10/2012
2.13.7
Availability for training and orientation of new staff.
One problem all clinics face is training new staff and assessing new appointments. QAPonline allows staff to access previous years EQA Schemes thereby allowing the QAP Supervisor to assess the progress of new staff training and the compatibility of new staffs visual assessment skills.
Updated: 22/10/2012
2.13.8
Varying skill level defeined at enrollment.
Variable access to QAPonline is accommodated by defining the status of each participant at enrolment. The updating of mean and SD in each quizzes master files facilitates this by including replies only from participants who have been marked by the QAP Supervisor as actively involved in the topic of the EQA Scheme. Replies from participants marked as in training or orientation are ignored in the calculation of the master tables.
Updated: 22/10/2012
2.13.9
Implication of dynamic access for Reporting
Data integrity for external quality comparisons is maintained by limiting the means and SD in the summary tables for both all VALID replies and for each company and laboratories. Reporting for a companies EQA performance is developed from information held in both master files. In this way, even though there are many options for data submissions, the data is filtered to provide only replies from valid and approved participants.
Updated: 22/10/2012
2.13.10
Annual Data Off site storage
Currently, the entire database (SQLServier) is downloaded annually and stored offsite.
