Medical Electronics System Automated Sperm Quality Analyzer -SQA - EQA programme.
!
Semen Analysis remains a largely operator based laboratory procedure. There are a number of automated systems available world wide and one produced by Medical Electronics Systems - the SQA automated sperm quality analyzer - has recently been introduced into Australian IVF and pathology laboratories.
The SQA processes a small volume of semen to estimates the concentration, the motility and based upon a algorithmised process, the morphology parameters. This information forms the basis of a semen analysis report that in Australia falls under NATA review for accreditation purposes. There is currently no external quality assurance programme to audit the performance of these units and as such laboratories seeking accreditation using such units are unable to demonstrate the units are under control. The SQAEQA programme under development by FertAid seeks to provide such demonstration. In general, each unit that provides clinical reports needs to be under its own EQA process. SQA provides samples of beads to calibrate its criteria for concentration.
The SQA unit requires very little professional skills to operate it. Such skills involving manual assessments have been plagued by high variability rendering semen analysis controversial in a clinical setting. The SQA unit does not have any capacity to accept a video stream from external sources and therefore does not lend itself to external auditing. Furthermore, the estimates of morphology are based solely on a motility profile argued to be reflective of motile sperm that have normal morphology - a parameter that while attractive, does not have sound WHO documentation. The WHO manual in Semen Analysis does contain considerable information on automated analysis.
The Process - In 2016, FertAid in conjugation with IVFA in Sydney, has developed an EQA programme based upon the use of thawed, frozen semen. This trial programme plans to dispatch frozen semen from HIV negative donors (either a individual single ejaculate or pooled ejaculates) in 2 rounds 6 months apart. A single straw from the test ejaculate(s) will be shipped to each participating laboratory in the programme. The laboratory will thaw and process the sample within a specific time frame and record a number of specific parameters. These results will be entered into FertAids QAPonline Internet based information system and the results will be processed in the same manner as all other EQA material.
Registration - Companies with Laboratories who wish to participate in FertAids SQAEQA programme will need to register with QAPonline with one staff member being responsible for all activities including subscription and auditing of activity. This person is called the QAP Supervisor. The supervisor can then add to the register each individual laboratory that operates a SQA unit. Historically, attached to each laboratory, would be one staff member with unique logon details who will be nominated to enter the data into QAPonline. However for this EQA programme, FERTAID requests you register a staff member as the SERIAL NUMBER OF THE MACHINCE. So that the machine will have a specific logon and password and will be staff ID independent. All performance reports for accreditation purposes will be details under the Operator/laboratory/Company banner. There will a fee per unit charged by FertAid for this service. Only one value can be submitted to each release for each unit.
Performance - Sources of variability may arise from variations between individual straws (since semen is not necessarily homogeneous), the thawing process that may influence the motility (and by default) the morphology, the time between thawing and assessment and other general handling AND of course between units. Please read the attached PDF (link below) on instructions for storage in Liquid nitrogen or Dry ice or immediate analysis. Remember the QAP in about motility ( and morphology since it is based upon motility) and failure to follow these instructions may result in a lower estiamte of these parameters that may theaten the efficiecy of your units (and others) performance.
Limitations of the SQAEQA PRogramme. The programme seeks to provide laboratories who elect to use the SQA analyser with tools to evaluate the performance of their unit compared to other units and provide supporting information for accreditation purposes. However, their use does not require an operator to visually inspect the sample nor to have any expert knowledge of semen analysis. Its calculation is based upon only a limited area for analysis and does not compare to the standards as detailed by WHO. This is not to say the reproducibility of units is any less inferior to visual inspection and operator bias - in fact FertAid expects to see significantly lower estimates of variability. The estimation of morphology, while of interest, is not the same as for WHO defined slide examination and the data obtained by the SQA and assessed by FertAid SQAEQA programme cannot be used by laboratories to report morphology without specific notation on the report as to its derivation.
Paramters Tested. There are a number of paramters the SQA unit produces but in conjugation with Dr Simon Cooke at IVFA, the following 4 parameters were choosen to be reviewed.
1. Concentration (Conc)
2. Total Motility - this parameter witll be the primary parameter for reporting purposes. (PR+NP)
3. Progressive Motility (PR)
4. Morphology Normal Forms (WHO 5th)
Comments and enquires to Dr James Stanger at office@fertaid.com
This programme is restricted to Australian clinics only because of logistical and costs reasons. If you are interested in developing a similar programme in your own regions, FertAid can reproduce this EQA specifically for your region. Pelase feel free to contact Fertaid for further discussions.
Please read the IVFA instruction PDF