Background

FertAid was established in 2001 and QAPonline a working subdivision and approved trading name initially to develop an alternative quality assurance program for IVF and pathology Andrology departments. Previous experience with EQASRM EQA model was disappointing for several reasons the principal ones being the disconnect between sample submission and report, the requirement to conduct Internal QC program fro individual staff members, the problem with using samples that dissociated the staff assessment skills to the sample handling.

Problems with sample based Andrology EQA models.

All EQA schemes in Andrology, except QAPonline, are based upon a sample based model whereby one or more samples are posted at regular intervals for a laboratory to process and submit a response. This is the same model as applied to biochemical type laboratories where one machine will process one sample. However Andrology is largely a VISUAL process rather than a machine based process and as such the scheme should be applied to ALL staff rather than one laboratory. Indeed, many laboratories ask all staff to process the sample and the mean value is submitted. This has the effect of reducing the range of submissions and providing an unrealistic estimate of variance.

Time between submission and reporting and educational feedback

Having participated in the External Quality Assurance in Andrology for many years, there were two issues that hindered my involvement. One was the long time between processing the sample and the receipt of the reports making responding to variations difficult to understanding why any one result varied. The second was that quality assurance and the education that was required to improve was absent. My discussion with others from overseas who also participate in sample based EQA schemes produced similar responses.

EQA schemes for Embryology and Ultrasoud.

While many pathology laboratories may perform Andrology assessments, there were no EQA schemes for Embryology and Ultrasound. For many IVF laboratories, this meant vary little since the only reason for participating and an EQA scheme was to gain accreditation and thereby Medicare benefits. QAPonline however viewed the need for an EQA scheme in Embryology and Ultrasound just as important as Andrology since these schemes target highly visual and interpretive process critical to a clinics operation. An EQA scheme focusing largely on Andrology therefore provided little support for these other functions.

Aims of QAPonline.

During the initial development phase, the basic model was to provide a vehicle whereby individual staff members were assessed on their visual interpretative skills rather than on their ability to re suspend a fixed sample. Towards this end, QAPonline was developed as an online process rather than a sample based process. The aim was to present all participants with a set of visual images, common to all participants, and then process their assessments as a common pool. This was in line with NATA guidelines which stated that "As far as practicable, all staff involved in testing patient's samples must participate in the QAP with records kept." [NATA Supplementary requirements for accreditation]. In other words, NATA require all machine processing a similar assay must each be enrolled in and EQA scheme. Likewise, QAPonline saw each scientist as an independent "machine" and expected each to individually participate in the EQA program.

Building IC and EQA from individual Competency.

The second pillar for QAPonline was to build from the individual contributions a broader dataset for comparisons. Since each reply is linked to individuals, laboratories and companies, QAPOnline is able to build Internal Quality Control Estimates from the all submissions in each laboratory and each company by using only the submissions from the laboratory or company AND build mean laboratory or company submissions for external comparisons against all participants (not a pooled mean submission). Finally from a management perspective, QAPonline allows construction of an estimate of each staff competency, bias and trending against the companies or global submissions.

Education Feedback and Continuous Improvement.

The third pillar of QAPonline was the capacity for any individual at any time to asses their performance at the time of submission. This allows each participant virtual feedback on how they assessed a "sample" relative to any other current submission. In addition, because the environment allowed for other questions to be asked, additional questions, related but not essential for the EQA assessment, to be asked that forms a second tier of education, feedback and training.

Continuous Submission and Dynamic Reporting

Unlike structured EQA schemes where end dates allowed data review, validation and reporting. QAPonline recognised that this places considerable restraints on data entry and inhibitions in late entries. QAPonline's approach is to provide a dynamic process fro both data entry and reporting. The key to facilitate this was to place the reporting in the hands of the senior scientists [termed the QAP Supervisor]. The summary of each EQA episode is held is separate master files against which all submissions are made. Each companies information is also is held in clinic master files that are also updated weekly. Reporting is made dynamical online using these two master files. In this way, reports are current.