March’s Quality Audit from the ARTC Digital Lab Playbook focuses on documenting general IVF lab CAP inspection preparations. This set of guidelines developed by the College of American Pathologists for quality laboratory environments ensures safety, precision, and accuracy!
Reach your quality improvement goals and higher standards of care for your patients, meet your regulatory requirements, and manage your laboratory more efficiently with ART Compass.
IVF labs are busier than ever. This month, we present you with a smart checklist of important and easily missed quality control items to ensure your lab is inspection ready. The ART Compass platform provides a digital method to track and control many of these items.
IVF lab CAP Inspection Preparation
Preparing an IVF lab for inspection requires attention to detail, ensuring compliance with regulatory standards. Essential steps include verifying the presence of certificates such as CAP, CLIA, FDA, and tissue bank permits, prominently displayed for inspection. Quality control (QC) records are meticulously reviewed to confirm that no parameters have fallen out of range during patient service, with corrective actions duly noted for any deviations. It’s imperative to ensure that all instruments and tests are in control, with the director’s sign-off on QC activities. CAP flyers should be visibly posted, and certificates of analysis for product shipments must be checked for validity, marked “ok to use,” and securely stored for reference, potentially in ART Compass for easy retrieval.
Additionally, documenting MEA and sperm motility assays, especially for products not tested by the manufacturer, is crucial for quality assurance. Records of these assays can be efficiently maintained in ART Compass, ensuring compliance and facilitating inspection procedures. Furthermore, items certified by NIST should be appropriately calibrated to guarantee accuracy and reliability in laboratory operations. By adhering to this checklist and maintaining meticulous records, IVF labs can confidently prepare for inspections and uphold the highest standards of quality and compliance.
Top 4 MOST Cited IVF Lab Deficiencies.
Liquid Nitrogen Levels; The laboratory has a written procedure to monitor and maintain adequate liquid nitrogen (LN2) levels and temperatures for all critical storage containers.
Competency Assessment of Embryology Personnel; The competency of each person performing embryology procedures, including micromanipulation and other assisted reproductive technology techniques is assessed.
Alarm Monitoring; Alarms are monitored 24 hours/day (either remote or in the laboratory) and there is a written procedure for responding to alarms.
Monthly QC Review; Quality control data are reviewed and assessed at least monthly by the laboratory director or designee.
We hope you enjoy our reminder to prepare these ahead of your CAP inspections!
Make some time to ensure:
- New CAP, CLIA, FDA, and tissue bank licenses are posted
- QC records are reviewed
- Nothing was out of range on any day of patient service
- Corrective actions are noted for any out-of-control instrument or test
- Ranges are revised for appropriateness
- Director has signed off on all QC
- CAP flyers are posted (do you need to order a new poster?)
- Check certificates of analysis exist for all relevant product shipments are marked “ok to use” (store them in ART Compass!)
- MEA and sperm motility assays are documented for certain products that are not tested by the manufacturer (again, you can record these in ART Compass by making an “MEA” patient”)
- NIST-certified items are appropriately calibrated.
Addressing QC issues is important in identifying and communicating potential errors with IVF lab operations. Running a well-controlled IVF lab sure requires a lot of attention to the details, which makes regular QC inspections imperative!
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | PMs, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | Grab bag! General Lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |