FERTAID QUALITY MANUAL. - TOC - Audit List - Reviews. Methods - - CONIFIDENTIAL - The content of this manual are Confidential.
Manual Record.
         
TOC
3.06 The Operation of the Proficiency Testing Schemes.
Since QAPonline is a database defined structure, the operation of each scheme is similar.
Notes      
3.06.1
Creation of EQA scheme Database Infrastructure.
 
Towards the end of October/early November, the EQA schemes for the following year are created. Initially, each scheme is replicated in full as a mirror of the current year. Then systemically the image linkages are modified to meet the aims of the scheme.
 
Updated: 7/1/2013
3.06.1.1
Initially, the linkage to each image or video is modified to ensure diversity . The new linkage is selected from the library of images/videos to check if and when it was previously used and that sufficient time has elapsed between repetitions. The release is then linked to a previous display in a separate file and used for intra-assay variability studies.
     
3.06.1.1
Videos are check to ensure they are in the current correct format (flash format). In 2011, QAPonline moved to replace all previous MPEG, MOV and AVI files with SWF (Flash) format. In some instances, a YouTube format and link have been created but since many clinics have banned YouTube access (due to staff usage), at present, SWF is the standard format. When these are played, a FLASH player is loaded to ensure that it will always play.
     
3.06.1.3
Questions are checked to ensure they reflect the image displayed (e.g. number of embryos, etc) and that a record in the summary file for each question has been created and initialised.
     
3.06.2
Creation of subscription Options
 
Since QAPonline primarily provides bundled subscriptions, i.e. a clinic will pay one subscription to gain access to a number of EQA schemes from which they select those they need, a number of subscription options are provided.
 
Updated: 7/1/2013
3.06.2.1
Global Subscription. This provides access to all the Embryology, Ultrasound and image based Andrology EQA Schemes.
     
3.06.2.2
Andrology bundled subscription provides access to all the Image based Andrology EQA Schemes
     
3.06.2.3
Embryology bundled subscription provides access to all the Image based Embryology EQA Schemes
     
3.06.2.4
Ultrsaound bundled subscription provides access to all the Image based Ultrasound EQA Schemes
     
3.06.2.5
Specialised subscription modules are created for unique, unbundled schemes such as Sperm DNA Fragmentation or Endocrine(AMH).
     
3.06.2.6
Subscription to any of the above schemes is usually created by the QAPonline Administrator based upon their previous subscription and a notice and invoice is sent by email to the Accounts staff manager.
     
3.06.3
Registration and Completion of a QAP Group
 
To initiate a subscription, one staff member, usually from the senior laboratory staff team will register with QAPonline. This requires disclosure of all address and other details. There is no fee to register.
 
Updated: 7/1/2013
3.06.3.1
It is possible for an individual to enrol in an EQA schemes without created but any replies cannot be linked to a future EQA group.
     
3.06.4
Set Up of the QAP Group - Laboratories, Staff,
 
Prior to subscribing, and following registration, the subscriber will create a QAP group with themselves as the QAP Supervisor (this can be changed at any time), create a record of all the laboratories within their clinical group or pathology company. After this they need to register each staff member who may be expected to participate in the EQA schemes. The list can be modified at nay time, new staff members can be added and retired staff members withdrawn from the staff list. Each staff member is allocated to a laboratory. A default laboratory is created when the QAP group is made to ensure all staff are allocated a laboratory linkage.
 
Updated: 7/1/2013
3.06.5
Subscription, Invoice, Payments
 
To gain access to the EQA Schemes, the QAP supervisor needs to access the subscription modules under the Supervisors Option and select a bundle fee subscription from the list and arrange payment of the invoice that is created.
 
Updated: 7/1/2013
3.06.5.1
When payment has been received, the QAP supervisor can then access the list of schemes that have been bundled into the subscription option chosen. From the list, they can select those schemes of interest to them. This selection can be changed at any time. The selected list of schemes is used to limit enrolment and review of schemes of no interest to the company.
     
3.06.6
Enrolment of Staff in EQA Schemes
 
The supervisor is responsible for the enrolment of each staff member in each scheme.
 
Updated: 7/1/2013
3.06.6.1
At enrolment, the supervisor can nominate the skill level of each staff member as either in training (such that their submission are excluded from analysis), professional or as a peer within the QAP group.
     
3.06.6.2
Staff may be enrolled at various skill levels in different schemes. The skill status is used as part of the internal QC analysis.
     
3.06.6.3
Staff enrolment can be withdrawn at any time as long as no submissions have been made. Once a submission has been received, the enrolment is fixed.
     
3.06.6.4
An email is posted to each staff member confirming their enrolment in each scheme.
     
3.06.6.5
Replies contain a link to the company, laboratory and the enrolment but the enrolment table contains a history of the skill level and experience (fro grandfather data analysis).
     
3.06.7
Individual Staff Participation.
 
Staff may access QAPonline and complete any release in any EQA scheme at any time. Access is data limed such that release after the current month cannot be accessed (e.g. February releases cannot be seen until February) but retrospective access is possible.
 
Updated: 7/1/2013
3.06.7.1
The list of current schemes and those from previous years can be accessed from the participants home page. A link to the current outstanding questions is also on the home page.
     
3.06.7.2
After each submission, QAPonline updates the quiz register to indicate to the administrator that another reply has been added for that quiz/question. The register of each participants activity in reach release is updated and the reply performance at that time is calculated, recorded and displayed to the user real time.
     
3.06.7.3
The user (Participant) can update the summary tables for each Quiz/Question and readjust their performance at any time.
     
3.06.7.4
The capacity for a user to review their performance real time differs considerably from other EQA programs. It is a key element in the education and training potential especially where a visual assessment has been made and where review at a later time may not be the same. The user may elect to review their performance against several other data sets as outlined in section 3.04.6
     
3.06.8
Review of performance by a staff member
 
Each individual as a set of tools available to review and analyse their performance. In addition, QAPonline has recently included a performance certificate (see below). This can be used for performance appraisals, job applications, competency and professional development documentation.
 
Updated: 7/1/2013
3.06.8.1
The first is a monthly review against a number of data sets including professional, all QAP group members (internal QC), professionals in the same country and professional of 10 years or more.
     
3.06.8.2
Worm Analysis where the SD from the professional mean is plotted over the last 30+ submissions for the KEY QAP question of the series.
     
3.06.8.3
Estimates of bias over the last 24 submissions of the KEY QAP Question.
     
3.06.8.4
MMCE scoring and certification. This is based upon Monash University Masters in Clinical Embryology Assessment criteria. The scoring gives 3 points to a reply within 1 SD of the mean, 2 to a reply 1-2 SD from the mean and 1 point for a reply 2-3 SD from the mean. The number of tallied for all replies and divided by the maximum possible score and converted to a percentage.
     
3.06.9
Review of the clinics and staffs performance by the QAP Supervisor
 
The QAP Supervisor or other nominated staff can review the performance the clinic, individual laboratories or individuals.
 
Updated: 7/1/2013
3.06.9.1
QAPonline has two levels of supervision. The QAP Supervisor controls staff and subscription. Other designations include a Co-Supervisor who has access to the reporting modules. See next section.
     
Ref:3.06 Operation of Proficiency Testing Schemes
Created:29/10/2012 Updated:7/01/2013