Staff quality assurance audits are extremely important for IVF labs! Competency and related metrics are the number one most cited IVF laboratory inspection deficiency. Embryology and andrology procedures are subjective, complex, and difficult to standardize. The lack of rigorously standardized laboratory protocols and strict quality control (QC) confounds even the best laboratories. Easily ensuring compliance with LQMS, CLIA, and WHO standards is an invaluable tool for clinics and laboratory directors. Accurate laboratory test results depend on staff being competent to perform a range of procedures and competency assessments are part of a laboratory’s quality documents, and should be periodically reviewed and used for continuous improvement.
You may have spent 25 years attaining the highest levels of precision and accuracy in your embryology procedures., but has anyone ever taught you how to manage staff? A rock solid team and happy balanced working environment are the keys to effective staff management and longevity of embryology teams. Teams that have played together for a long time are winning teams, teams with high embryologist turnover and burnout are constantly destabilized. In the ARTC IVF Lab Playbook, the month of October is all about preparing for the coming year. Effective staff management is a skill that IVF lab Directors can learn. Here are our suggestions!
One Month Schedule of Staff related IVF Lab QA Activities
The lab director or quality manager should each month by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. As activities are completed or learned about, each item is marked “Complete”. This will document both continuing education and quality assurance activities.
| Competency assessments for each procedure in lab. Particularly, for clinical decisions. | Give your answers first in the ART Compass app, then assign surveys to staff: Some fun ones? Where to nick sperm tail. Where to hatch on Day 3. How to hatch blast for FET, choose to freeze or discard, to biopsy or culture more, fertilization, egg maturity, grading for day 3 / blast systems. For FETs, transfer or thaw another? |
| Eye color survey | Staff meeting to review why seeing the color red is important in an embryology lab. Assign “All About Media and pH” and “Color Vision” in ARTC. Document color vision for staff file. |
| Training documents up to date | Review training stats, 6 month review, one year review for trainees. |
| Annual procedure evaluations | Document 6 CAP checklist items for fully trained embryologists yearly. |
| Assess the IVF Lab Supervisor’s ability to supervise. | Embryology supervisors must have at least one year of supervisory experience in all aspects of embryology performed by the laboratory or a minimum of 60 cycles over a period of not less than six months. Furthermore, the performance of section directors/technical supervisors, general supervisors should be separately assessed and satisfactory. |
| Lab Director Annual Review | Lab directors can benefit from a Lean 6 Sigma approach. Gather performance reviews from someone below you, at the same level as you, and above you. What are your blind spots? Where do you excel? |
| Continuing Education Review and plan for upcoming year | There must be a functional continuing laboratory education program adequate to meet the needs of all personnel. The ARTC IVF Lab playbook provides suggestions for CE activities for each month, and methods for easy documentation and automated follow up. Additionally, discuss with staff research interests, desire to attend conferences and dates, and plan the advanced off-site plan for continuing education. |
| Staff degree or certificate posted | Certificates can be posted above computer work stations. |
| Update personnel records. | Upload job descriptions, CV, resume, transcripts for foreign degrees, and continuing education certificates to your ARTC profile. |
| Update Organization Chart | There must be an organizational chart for the laboratory, or a narrative description that describes the reporting relationships among the laboratory’s owner or management, the laboratory director, section director(s)/technical supervisor(s), technical consultant(s), clinical consultant(s), and supervisor(s)/general supervisor(s), as appropriate. |
| Order Holiday or World Embryologist Day Gifts | Great gifts for embryologists can be found here, here and here! |
| Plan Holiday Party | Where will your team celebrate the years achievements and accomplishments, and bond together outside of work? A restaurant, bar, or park? |
CLIA regulations require laboratories to participate in some form of proficiency testing (PT) for every test that they perform on patient specimens at an interval of not less than twice per year. Accrediting agencies may have their own PT requirements for non-diagnostic tests or services such as those provided by the Embryology laboratory. Examples of testing that requires a minimum of an alternative assessment (not external PT) include sperm morphology, sperm motility, sperm choice for ICSI, where to nick a sperm tail and all embryology procedures/tests; oocyte maturity, fertilization check, day 3 grading, day 3 hatching, blastocyst grading, decision to freeze, decision to biopsy, decision to transfer or thaw another among others.
ART Compass provides HIPAA-compliant ways to assess the clinical decision making of ART laboratory staff for andrology and embryology competency. The competency assessment modules provide standardized instructions to test-takers and can be used to measure inter and intra- technologist variability between embryologists. Competency assessment surveys have been designed to allow the ART/ IVF laboratory director to gain insight into the clinical decision making of the most senior staff and compare that to junior staff members. For example, for choice of sperm for ICSI, or top choice of embryo for cryopreservation, biopsy, and transfer, and inform the key performance indicators (KPIs) used to continuously monitor and assess culture conditions. Mobile application technology was designed to allow standardized specimens to be served to each technologist at each study site simultaneously, allowing even very small IVF clinics to compare an individual technician’s values to the mean of all technicians and to technicians in a central laboratory. Test pictures, videos, and written test questions are randomly refreshed from a large database of multimedia files to eliminate bias.
Current assessments methodologies are extremely limited, perhaps to just one cleavage stage embryo and one blastocyst image every 6 months, and they cannot be customized to a lab’s own grading system or clinical question(s) of interest to that particular lab. ART Compass assessments are unlimited and completely customizable- from the images to the buttons to the test directions and the pre-test video can deliver learning content or instructions and demonstrations. They have also been validated and you can read more in JARG and Human Reproduction.
The mobile app documents ALL aspects of laboratory information assessment, not just for embryos and sperm but including; basic lab, continuing education, biohazard safety, handwashing, color vision, and FDA regulations among many others. ART Compass provides standard forms used by all employees. It documents competency assessment records, time and date stamps results, and is completely confidential. These records become part of the laboratory’s quality documents, and can be periodically reviewed and used for continuous improvement and quality assurance.
| WHO Competency Assessment Procedure Recommendations | ART Compass Features |
| The assessor contacts the employee in advance to inform her/ him that the assessment will be done at a prearranged time. | Push notifications, employee dashboard, application inbox. |
| The assessment can be done while the employee is performing tasks using routine sample images. | Smart-phone design allows for integration into daily work flow. Multimedia image and video databases eliminate bias and are more similar to routine sample analysis. |
| The assessment is done by a specified method previously described and is recorded in a digital “logbook.” | Standardized test protocols and check for understanding modules. A digital record is permanently saved to the administrator console and displayed in director and technologist dashboards. |
| The results of the assessment are shared with the employee. | Technologist dashboard |
| A remedial action plan is developed defining required retraining. | The app communicates specific steps to be taken to correct the problem with related deadlines, date and time stamped, through the inbox. For example, the employee may need an updated version of the standard operating protocol (SOP). |
| The employee is asked to acknowledge the assessment, related action plan, and reassessment. | Inbox records the interaction and response and date and time stamps it. Tests attempted, completed and passed, or tests to be re-attempted are prominently displayed through badges on the technologist dashboard. |
Additionally, pictures, videos, and written test questions are randomly refreshed every month from a large database of multimedia files to eliminate bias (being familiar with images and expected answers for example) for an ART laboratory’s quality assurance plan.
Evaluating and documenting competency of personnel responsible for testing is required at least semiannually during the first year the individual tests patient specimens, and at least annually thereafter. Competency assessment must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform. The following six (6) procedures are the minimal CLIA regulatory requirements for assessment of competency for all personnel performing laboratory testing.
| CLIA Requirements | ART Compass Annual Procedure Evaluation |
| Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. | Observation of Performance |
| Monitoring the recording and reporting of test results | Test Report Completion |
| Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records | QC/PT/PM Records |
| Direct observations of performance of instrument maintenance and function checks | Instrument Maintenance |
| Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples | Peer Assessment |
| Assessment of problem solving skills | Problem Solving |
September is a great time to perform an FDA Compliance quality assurance audit in your IVF Lab! Visit the IVF Lab Playbook.
| September | FDA Audit |
| October | Staff Audit |
| November | Patient Satisfaction and Security |
| December | Space and Supplies |
| January | Preventative Maintenance, Air Quality, and Deep Clean |
| February | Biennial P&P Updates, Review, and Sign Off |
| March | |
| April | |
| May | |
| June | |
| July | |
| August |
