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 |
Competency Assessment vs Proficiency Testing. Do IVF Labs Need Both? Tl;DR – YES! We explain why.
“One thing worse than training employees and losing them… is not training them and keeping them.” -Ed Metcalf
Competency Assessment vs Proficiency Testing. Does my IVF lab need to perform both? The short answer is yes!
Learning Objectives
— What is the difference between proficiency testing and competency assessment?
— When do you need to perform PT?
— When do you need to perform CA?
— What are the 6 elements needed to perform a CAP level CA?
— When do you need to perform PT?
— Define the criteria for satisfactory proficiency testing (PT) performance.
— Describe the consequences of unsatisfactory performance of a PT event.
— Take the appropriate steps to investigate a PT failure.
— Discuss the advantages of standardization and digitization for documentation of training, performance, and corrective actions.
Until each staff member has documented training, followed by successful assessment of competency of that task, they should not be permitted to perform or result patient testing independently of their trainer. Embryologist training, competency acquisition and documentation of these activities for inspections hasn’t advanced in 40 years, until now. ART Compass is outsmarting the embryologist shortage, reducing non-conformance events, and helping you pass quality inspections, defeating CAPs number one most cited deficiency, staff-related checklist items- download our complete full length, peer reviewed study here, “Assuring quality in assisted reproduction laboratories: assessing the performance of ART Compass – a digital ART staff management platform.”
Whether you’re subject to CLIA, CAP or your local state DOH requirements, you will be required to provide proof (documentation) of both training AND competency for each employee, for each task that they perform. Documentation of all of these tasks can be organized through the use of advanced digital IVF lab management tools, like ART Compass. ART Compass helps savvy IVF lab directors keep track of what each staff members’ specific job junctions include, which they need to be trained in, and which tasks have been completed by each trainer.
Proficiency Testing
Before passage of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), participation in proficiency testing (PT) was voluntary for many labs and the standards for these tests were not defined. With passage of CLIA ‘88, proficiency testing evolved from an educational self-assessment and improvement tool to the primary measure of continued reimbursement and licensure.
Proficiency testing determines the performance of individuals for specific tests or measurements. Performance on PT has been found to be an indicator of the quality of patient testing. By CLIA standards, clinical laboratories are required to enroll in a CMS-approved PT program for all regulated nonwaived testing, and their performance is compared to a target value using statutory criteria for acceptable performance. For nonregulated, nonwaived testing or for tests that have no formal PT available, CLIA requires alternative assessment, twice per year.
Failure of a single event (<80%, or <100% for immunohematology) requires an investigation to ensure that processes were followed correctly throughout all phases of testing: preanalytic, analytic, and postanalytic. This type of unsuccessful performance does not require that a response be returned to the PT program or to the facility’s accreditation agency. However, if two consecutive events or two out of three consecutive events for the same procedure receive an unsuccessful grading, consequences are more severe. The laboratory must take steps to discontinue the procedure. It is best to notify the accrediting agency of the voluntary discontinuance before the accrediting agency notifies the laboratory.
Next, the problem should be investigated, corrective action implemented, and two consecutive successful PT events must be performed. The events can be independently obtained through the ART Compass program. Finally, the accrediting agency must be notified of the corrective action and the intent to reinstate testing.
Embryology procedures fall under nonregulated, nonwaived testing. This requirement can be met by subscribing to a formal program, such as ART Compass, which offers testing for all embryology procedures. The target values in ARTC are determined two ways: by the mean of all peer participant responses after removal of outliers, and by IVF Lab Director consensus. Acceptable performance is considered to be 80%.
You may access a Proficiency Testing Policy and Procedure in ART Compass, by logging in online via a Chrome Browser and navigating to the green tab “Documents and Forms,” then click on the “Quality” folder. Use the “Show to” feature to select any individual who needs to read and review the policy.
Competency Assessment
Embryologist competency assessment is an ongoing, continuous process of monitoring individuals’ abilities to perform their specific job functions.
Once training has been completed and documented in ART Compass, you will assess each staff member’s clinical decision-making ability to successfully perform these tasks using our robust suite of subjective “surveys.” This is their competency, where you assess if the training was successful and staff are able to perform each assigned task correctly.
You may access a Competency Assessment Policy and Procedure in ART Compass, by logging in online via a Chrome Browser and navigating to the green tab “Documents and Forms,” then click on the “Quality” folder. Use the “Show to” feature to select any individual who needs to read and review the policy.
CAP Requirements for Competency Assessment:
ART Compass contains a robust suite of tools for staff management, including a Staff-Quality Audit and subjective competency assessments for each embryology procedure, as well as objective surveys for topics of interest such as Media and pH, FDA regulations, HIPAA Compliance, PPE and Bloodborne Pathogens and much more! Two ART Compass digital tools, a conventional checklist and our Competency Assessment 2.0 document capture module (use your phone camera to record evidence) will guide your competency evaluations and document evidence of completion for all required procedural steps.
To fully demonstrate successful competency all 6 of the following elements must be documented for each employee, for each task:
Direct observation of routine patient testing — Watch (and snap a picture!) as employee performs routine work processes and procedures, including; patient preparation, specimen handling, processing, and testing.
Monitoring the recording and reporting of test results — Review worksheets, computer printouts, or manual test logs for results or entries that are incorrect or incomplete. The worksheets, logs, and printouts should be compared to final test reports, evaluated turnaround times, and for compliance with policies and procedures.
Review of intermediate test results, records, and proficiency testing results — Review testing documentation, to include test results or worksheets, documentation forms, QC logs, proficiency testing documentation, and other applicable documentation for completion of proper policies and procedure. Documentation of review will include follow up of corrective action related to problems in the laboratory.
Direct observation of instrument maintenance and function checks — Watch employee perform instrument maintenance and function checks as compared to documentation for completeness and correctness of process and expected outcome.
Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples — Assessment of previously tested samples; internal blind samples or external proficiency testing samples.
Assessment of problem-solving skills — Include review of problem logs, incident reports, and QC failures; Review corrective actions employed to resolve the problem. Personnel interviews (staff narrative) may also be included for documentation.
PT Failure: Now What?
Unsatisfactory PT performance makes up approximately 3.2% of all CMS survey deficiencies. Inappropriate PT enrollment makes up 1.8%, and failure to perform alternative assessment of nonregulated testing makes up 6% of deficiencies (Yost, 2011). The suggested steps for investigating PT failure are:
- Survey Materials: On receipt of the survey materials, verify that they were received in acceptable condition. Should any unacceptable conditions or criteria be noted, notify the PT program as soon as possible for shipment of replacement samples. Ensure that the samples are stored according to the manufacturers’ instructions until analysis.
- Clerical Error: Errors of this type are the most commonly reported and may be of various types. They include typographical errors as well as errors related to interpretation, transcription, transposition, misidentification, answer-form coding, miscalculation, or acceptance of a nonlinear result. Manual entry offers more chance for transcription or transposition errors. Electronic entry still allows for incorrect keystrokes and/or options to be submitted.
- Technical Problems: The most common assumption when assessing technical issues is that the reagent and/or instrumentation reported an inaccurate result. This may be exhibited by the quality control value falling out of the acceptable range for the analyte and the run being accepted. Quality control results that demonstrate excessive repeats, shifts, or trends may also affect PT results and should be carefully scrutinized in the investigation.
- Method Problems: These types of errors include instrument problems, maintenance issues, or faulty reagents and/or standards. Verify that the instrument was within performance guidelines the day of PT. Were there repairs or component replacements recently done that could have affected the PT results?
- Could the error have affected patient testing? If so, document the actions taken to ensure that the patient testing reported at the time of the unsatisfactory PT was valid or whether amendment is needed. It is necessary to notify providers if any inaccurate results were reported.
- The final steps of the investigation are to determine the problem(s) and summarize the findings in your documentation. Include any supporting documents for the findings. These may include proficiency report records, instrument data, quality control records, calibration records, maintenance logs, and any other records found to be of assistance. Document the corrective action taken to remedy the problem and that steps that will be taken to prevent the problem from recurring.
Documenting PT performance in ARTC
A logical approach and use of a standardized investigation forms may be a reassurance that possible critical steps in the investigative process were not overlooked, and variables were examined for the root cause of unsatisfactory proficiency testing performance. You can find free resources in ART Compass to troubleshoot failed or unsatisfactory PT events. 1. In the surveys module of ARTC you will find The IVF Lab Digital Playbook -> Investigation of Proficiency Testing Results. 2. Access ARTC online, navigate to the green tab “Documents and Forms” and assign the “Investigation of Proficiency Testing Results”to a staff member.
Embryo Selection has been proposed as one of the top Infertility research priorities. Healthcare professionals, people with fertility problems and infertility researchers (healthcare funders, healthcare providers, healthcare regulators, research funding bodies and researchers) were brought together in an open and transparent process resulting in an article that was published in Human Reproduction in November 2020 outlining the top future infertility-related research priorities. The initial survey was completed by 388 participants from 40 countries, and 423 potential research questions were submitted. Fourteen clinical practice guidelines and 162 Cochrane systematic reviews identified a further 236 potential research questions.
The top 10 infertility research priorities for the four areas of male infertility, female and unexplained infertility, medically assisted reproduction and ethics, access and organization of care for people with fertility problems were identified. These top ten research priorities in each topic area outline the most pressing clinical needs as perceived by healthcare professionals, people with fertility problems and others, to assist research funding organizations and researchers to develop their future research agenda.
This post discusses research priority #4: What is the optimal method of embryo selection in IVF cycles?
- An article was published in Human Reproduction in November 2020 outlining the top future infertility-related research priorities. The top ten ART research priorities are;
- What are the causes of implantation failure?
- What is the optimal treatment for women undergoing IVF who are poor responders to increase live birth rates?
- What is the optimal method of sperm selection in IVF cycles?
- In couples with unexplained infertility, does IUI increase live birth rates when compared with other ARTs, including IVF?
- In couples with unexplained infertility, what is the optimal number of IUI cycles before moving to IVF?
- What is the optimal method of embryo selection in IVF cycles?
- What are the factors that affect cycle to cycle variability in the number and quality of oocytes produced in an IVF cycle?
- What is the optimal time interval between ovulation and IUI?
- What is the emotional and psychological impact on children born using donor gametes?
- What is the emotional and psychological impact of repeated fertility treatment failure?
- Why is Embryo Selection a research priority?
- The primary goal of embryo selection is to produce a live birth from a single embryo transfer and to minimize detrimental outcomes, like implantation failure, miscarriage, or birth defects.
- Noninvasive imaging (microscopy) systems for gametes and embryos is the primary grading and selection method
- Common:
There are three techniques for imaging live, transparent specimens.
Phase contrast passes light through the sample, so the image is light and dark based on the DENSITY of the sample. HMC (Hofmann Modulation Contrast) and DIC are very similar- both are rendering an image based on the rate of change in the optical path- the slope. However, they do it different ways. In HMC a filter is used to amplify certain signals- in this case, the signal is light that has refracted as it passed through the sample. In DIC light is split into parallel beams and directed at the specimen, then they are further affected as they pass through the specimen, then recombined and analyzed on the other side. DIC relies on waves of light interfering (or not) with each other. The major problem with phase contrast is that it produces “halos” of light. The major problem with DIC is that orientation of the sample matters a lot (so swimming sperm- as they change their orientation- would not be good to view with it). Additionally, you must use glass coverslips/ slides or plates with the same refractive index – whereas with HMC you can use a plastic dish, PVP etc all having different refractive indices than the sample.
- Rare:
- Polscope. Visualize meiotic spindle placement and formation with polarized light. Now we predict the position of the spindle by positioning the 1st polar body at 12 on the clock when we do our ICSI injections. But the spindle is not always there, and we can damage the chromosome apparatus during the injection causing the second polar body to not be able to extrude from the egg, and failed fertilization. If the spindle has not formed when we inject the egg usually dies. So the method we have now works for 90% of eggs. We don’t usually have access to this specialized microscope.
- MSOME and IMSI. Expensive experimental systems that require extended handling of the sperm, potential to cause more oxidative damage, lack of agreement on what marker of any indicates sperm DNA damage (vacuoles, cytoplasmic droplet)
- Time lapse monitoring. Expensive and most labs do not have it. Incubation system where the embryos are placed and grown continuously and monitored. Right now, we take embryos from their little culture chamber and inspect them at set time points. Usually at fertilization, day 3, and then 5/6/7. Time lapse can record things we miss in between those checks. Positive selection criteria include the positioning of the pronuclei and a small organelle called the nucleoli inside them, number of blastomeres, the absence of multinucleation, early cleavage to the two-cell stage, and a low percentage of cell fragments in embryos.
- Genetic screening selection techniques like PGT-A are peaking in several countries
- New controversy: polygenic trait selection of embryos
- There have been and continue to be many many controversies in genetic testing of embryos: namely, mosaic embryos and “segmental aneuploidy” embryos can self correct and make healthy pregnancies 30% of the time.
- Algorithmic and artificial intelligence scoring generated by computers is gradually enhancing our selection process, these are becoming more widely used.
- EMA by AiVF is a multi-module integrated platform that combines AI, computer vision, and big data to improve the success rates in patients undergoing IVF treatment. Its genetic evaluation tool can determine if the given embryo is genetically suitable for transfer by avoiding an invasive biopsy. AiVF has the largest embryo database in the world and the platform offers objective and automatic tools. One groundbreaking study from AiVF, tested the effectiveness of EMATM, AiVF’s multi-module integrated platform, which combines AI, computer vision, and big data. According to the study, EMATM detected significant differences between aneuploid and euploid embryos during the first five days of embryonic development. This was based on a retrospective study involving 2,500 embryos with PGT-A results – 1,000 euploid (genetically normal) embryos and 1,500 aneuploid (genetically abnormal) embryos. Aneuploid embryos were significantly more likely to reach each specific embryo developmental event later than euploid embryos and the time gaps between developmental milestones were also statistically longer in aneuploid embryos.
- In general, lack of video imaging systems for continuous monitoring and single step embryo culture systems, as well as lack of data handling methodologies, are holding these back from widespread deployment.
- The race has been on to find metabolomic markers for embryo selection
- What is the embryo using for energy and growth, and what are its waste products?
- The metabolomic profiling of embryo culture media has been performed through proton nuclear magnetic resonance (1H NMR). Researchers have discovered that the metabolomics profile is correlated with embryo reproductive potential. From the proton NMR spectrum, alanine, pyruvate, and glucose levels were reduced in the culture media of embryos that resulted in pregnancy. Glutamate levels were found to be higher compared to embryos that failed to implant, possibly due to its generation from α-ketoglutarate and ammonium, thereby lowering the potentially toxic ammonium to developing embryos. A sensitivity ― the ability to identify true implantations/pregnancies ― of 88.2 percent and a specificity ― the ability to correctly predict no implantations/pregnancies ― of 88.2 percent was achieved through 1H NMR
- Protein markers from the embryo culture medium
- Not too many have been discovered, but surely there are more. Healthy embryos will be producing characteristic proteins as they go about their work growing.
- In one study by Noci et al., soluble human leukocyte antigen-G (sHLA-G) was isolated and considered as a possible protein marker of embryo reproductive potential. The presence of sHLA-G shows no correlation with embryo morphology, and the lack of sHLA-G in culture media has a negative predictive value. In another study in which sHLA-G-positive embryos were transferred, implantation and pregnancy rates were 44 percent and 75 percent, respectively, compared to 14 percent and 23 percent of transferred sHLA-G-negative embryos.
- A protein biomarker that has been found to be upregulated and increased during embryo maturation into the blastocyst stage is a Day 5 secretome ― a set of proteins secreted from the cell ― resembling ubiquitin. Ubiquitin has been implicated in the turnover of key signaling molecules during implantation
- Other non-embryonic genomic markers (cumulus cells) have potential
- The cumulus cells (CCs) that surround the oocyte from fertilization until implantation have been analyzed and gene-profiled to gauge embryo potential: the likelihood of an embryo to implant and lead to a successful pregnancy. Several genes expressed in CCs have been correlated with predicting pregnancy, including cyclooxygenase 2 (COX2), steroidogenic acute regulatory protein (STAR), and pentraxin 3 (PTX3). Two upregulated biomarkers have been identified in the CCs of successful pregnancies, BCL2L11 and PCK1, which are involved in apoptosis of abnormal cells and gluconeogenesis.
The ARTC Digital Lab Playbook February Quality Audit focuses on documenting the biennial IVF lab policy and procedures review. When should IVF Lab policies be updated? What elements make an effective policy? How should they be reviewed? What is sufficient evidence that each policy has been reviewed?! This month’s quality audit answers all of these questions and more!
IVF Lab Policy and Procedure Review
This quality management process ensures policies and procedures are up-to-date, and that all staff members who must comply with your policy or monitor their implementation have been throughly trained. It may be useful for your organization to develop a communication strategy that identifies everyone who needs to be aware and comply with the policy. Scheduled review dates ensure continuous improvement when:
A gap/need is identified.
A serious or critical incident has occurred, requiring an urgent review.
Changes occur in the operating environment
Changes in laws, regulations, government policies, or CAP.
There are several objectives to policy and procedure review and sign off. The CAP All Common checklist, COM.10200 says that the laboratory director must review and approve all new technical policies and procedures, as well as substantial changes to existing documents, before implementation. A paper or electronic signature review of records is required, but a secure electronic signature is highly recommended. When a policy or procedure is discontinued, a paper or electronic copy must be retained for at least two years, with a record of the initial date of use, and retirement date.
With respect to procedures, the CAP says that a complete procedure manual should be available in a paper-based, electronic, or web-based format at the workbench or in the work area. A schedule should be developed where roughly 1/24 of all technical policies and procedures are reviewed monthly, in order to minimize the burden on the laboratory and reviewer(s).
After review, a paper or electronic signature must be recorded at the level of each policy or procedure. A single signature on a Title Page or Index is not sufficient to record that each policy or procedure has been carefully reviewed.
According to CAP general requirement GEN.20375, IVF laboratories must have a document control system to manage policies, procedures, and forms that are subject to CAP accreditation. All of these objectives are easily met by the documents and forms control module in ART Compass.
Effective policies clearly state:
Purpose: A statement that explains the goal(s) the policy is intended to achieve.
Findings: Brief statements of fact and /or statistics that outline the issue being addressed and support the need for the policy.
Definitions: Detailed explanations of the key terms in the policy.
Provisions: The main policy provisions state the prohibitions and/or requirements of the
policy and identify the parties to whom the provisions apply.
Exemptions: Any exemptions or exceptions to the prohibitions or requirements that are necessary to achieve the purpose of the policy.
Enforcement: An Enforcement section identifies the parties responsible for enforcement, outlines the enforcement procedures, any penalties or fines that may be imposed, and any appeal process.
Implementation: The implementation section states the effective date for the policy and the steps to
disseminate and publicize the policy.
One Month Schedule of Annual Policy and Procedure Updates, Review, and Sign Off related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”.
| Research and Analysis | Analyze CAP Checklist to determine if new policies need to be written or existing policies updated. Cap Checklist Management Tools are available in ART Compass. |
| Distribution | The policies and procedures has been distributed to those expected to implement it and follow up feedback will be sought to ensure the policy is understood and applied. Use the “Assign” function in ART Compass! |
| Dates | Check that policies and procedures include the implementation date when the policy becomes active, dates and notes about changes or edits, and end use dates. |
| Review Schedule | Policy includes a review date – recommended 1/24 per month to completion every two years. |
| Supporting Documents | Supporting documents, such as forms, checklists or guidelines that will assist staff to implement policy have been developed. |
| Policy Scope | The scope of the policy lists all staff positions with responsibility for implementing the policy. |
| Critical or Panic Values | Policies identify what constitutes a breach of the policy and what the consequences are, and/or panic values that require immediate notification of a physician. |
| Sign Off! | IVF Lab Director, Medical Director and Technologists acknowledge they have read and understand the policies and procedures, supporting documents, and checklists. All employees can record their sign off on each P&P in ART Compass. |
The CAP requires various policies. Do you have a policy to address each of the following?
| GEN.20310 | Written QM policy and processes for performing a root cause analysis or investigation of non-conforming events |
| GEN.20340 | Written policy for the handling of recalls and notifications |
| GEN.20374 | The laboratory has a policy for ensuring compliance with applicable national, federal, state (or provincial), and local laws and regulations. |
| GEN.20377 | Written policy for retention of records, specimens, and slides |
| GEN.20450 | The laboratory follows a written policy for the management and correction of laboratory records, including quality control data, temperature logs, and intermediate test results or worksheets. |
| GEN.26791 | The laboratory has a written policy that addresses compliance with the CAP terms of accreditation. |
| GEN.40492 | The laboratory has a written policy regarding correction of information on specimen labels. |
| GEN.40506 | Written policy defining criteria for storage of and access to specimens collected by chain-of-custody procedures |
| GEN.40509 | Written policy addressing restricted access to secured records and record retention. |
| GEN.40935 | Personnel receiving verbal or phone orders read back the entire order to verify accuracy of transcription. |
| GEN.41304 | There is a written policy to ensure that patient data are accessible in a timely manner only to those individuals who are authorized to review test results. |
| GEN.41345 | Written policy defining test reporting turnaround time and process for communication of delays in turnaround time |
| GEN.43325 | Written policy defining mechanism for data protection |
| GEN.54200 | Written policy for continuing laboratory education |
| GEN.59980 | The laboratory has a written policy for restricting access to the laboratory to authorized individuals. |
| GEN.74400 | There is a written policy that prohibits smoking, vaping, eating, gum chewing, drinking, application of cosmetics and lip balm, manipulation of contact lenses, and mouth pipetting in all technical work areas. |
| GEN.77300 | The laboratory has a policy to protect personnel from excessive noise levels. |
| 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 | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
The ARTC Digital Lab Playbook January Quality Audit focuses on documenting the IVF lab deep cleaning, preventative maintenance, and air quality. Most IVF labs appear to “shut down” for the week between Christmas and New Year. But we never really close! We are hard at work behind the scenes, ensuring that every instrument we use in the IVF lab and even the environment itself is strictly maintained to provide the best patient care.
Preventative Maintenance
IVF lab equipment must be properly installed, maintained, and calibrated to protect the quality of patient embryos. A great preventive maintenance routine includes cleaning, monitoring and repairs, and timely replacement of any component that shows signs of failure. A proactive and preventative approach allows the IVF Lab to predict potential problems, plan to move precious samples to properly functioning equipment, optimize maintenance schedules (e.g. equipment calibrations), and ensure that the lab can pivot when critical equipment is being repaired or replaced.
The future of IVF lab management includes assistance from Artificial Intelligence systems. In the realm of quality control and assurance, this is called predictive maintenance: knowing how to target future issues or failures before they happen, enabled by continuous monitoring of equipment, historical data, and development of predictive algorithms.
The IVF lab typically has numerous highly sophisticated instruments that need to be maintained, among them are; benchtop incubators, box incubators, warmers, heated surfaces for microscopes, isolettes, laminar flow hoods, pipettors, timers, thermometers, analytical balances, micromanipulators, inverted microscopes, water purifiers, and heating and ventilation systems with sophisticated filtration and pressure requirements.
The CAP generally requires preventative maintenance to be performed and documented.
| COM.30550 Instrument/Equipment Performance Verification | The performance of all instruments and equipment is verified prior to initial use, after major maintenance or service, and after relocation to ensure that they run according to expectations. |
| COM.30600 Maintenance/Function Checks | Appropriate maintenance and function checks are performed and records retained for all instruments (eg, analyzers) and equipment (eg, centrifuges) following a defined schedule, at least as frequent as specified by the manufacturer. |
| COM.30675 Instrument and Equipment Records | Instrument and equipment maintenance, function check, performance verification, and service and repair records (or copies) are promptly available to, and usable by, the technical staff operating the equipment. |
The CAP requires specific instrument preventative maintenance to be performed and documented.
| COM.30680 Microscope Maintenance | Microscopes are clean, adequate (eg, low, high dry and oil immersion lenses as appropriate for the intended use), optically aligned, and properly maintained with records of preventive maintenance at least annually. |
| COM.30700 Thermometric Standard Device | Thermometric standard devices must be recalibrated, re-certified, or replaced prior to the date of expiration of the guarantee of calibration or they are subject to requirements for non-certified thermometers. |
| COM.30820 Quantitative Pipette Accuracy and Reproducibility | Pipettes used for quantitative dispensing (eg, adjustable volume, micropipettes, dilutors, and analytic instruments with integral automatic pipettors) are checked for accuracy and reproducibility initially and according to the manufacturer’s recommended interval, or at least annually if not specified, and the results are recorded. |
| COM.30860 Analytical Balance Maintenance | Analytical balances are cleaned, serviced and checked at least annually by qualified service personnel. |
Air Quality and VOCs
New car smell, paint, dyer sheets, perfume, pine tree, and orange zest all have one thing in common; Volatile Organic Compounds (VOCs). Not all VOCs smell good, not all smell bad, and some have no odor at all. VOCs are nasty compounds like benzene, isopropanol and pentane, as well as particulate matter, carbon monoxide, nitrous oxide, sulphur dioxide and heavy metals. People have organs systems to combat these environmental stressors, lungs, spleen, kidneys, liver, antioxidants that can mop up free radicals and prevent major damage to cells. However, eggs, sperm, and embryos have been removed from the body and don’t have their own antioxidant systems.
Construction materials like MDF, PVC flooring, paints and adhesives, are the major source of VOCs indoors, while the compressed gasses that run our incubators are the major source of benzene, isopropanol and pentane; city air and natural disasters such as wildfires and heat waves bring the noxious gases and heavy metals. Laboratory plasticware, which is made from a variety of plastics like polyethylene, polystyrene, polycarbonate, polypropylene, and acrylic, release VOCs. All of these are bad for embryo development, and air quality unrefutably has been shown to impact pregnancy outcomes. Particle monitors and VOC counters are now important instruments for quality control. New laminar flow hoods and extensive “inline” gas filtration units for incubators, as well as standalone or ceiling / roof mounted air filtration systems with HEPA and VOC filters, and airflows and airlocks that maintain positive pressure are necessary for modern clean room IVF lab design. Currently, it has been generally recommended that IVF laboratories maintain total VOC levels below 400 to 800 ppb.
Deep Clean
The IVF lab must be kept clean and sterilized, but without the use of harsh cleansers and soaps, or disinfectants like ethanol that might emit harmful VOCs. Good practice points are to leave a specific pair of shoes for lab use only, wear clean scrubs that are put on in a clean room, always wear PPE to catch hair shedding (heads and beards!).
| GEN.42750 Computer Facility Maintenance | The computer facility and equipment are clean, well-maintained and adequately ventilated with appropriate environmental control. |
| GEN.61500 Environment Maintenance | Floors, walls and ceilings are clean and well-maintained. |
| GEN.61600 Environment Maintenance | Bench tops, cupboards, drawers and sinks are clean and well-maintained. |
One Month Schedule of Preventative Maintenance, Air Quality, and Deep Clean related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”.
| Dust, starting at top of hoods and lab shelves and moving to floor level – clean all microscopes, wipe all electronics, cords, incubator and hood tops and stands, stools and chairs. Legs of tables and hoods. | Dust accumulation should be cleared quarterly and a deep dive undertaken once a year. Fine dust filters should be used. Low lint scrubs should be worn, and care should be taken to dispose Swifter cleaning cloths outside of the laboratory trash can. |
| Clean and sterilize all incubators and water trays | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Wipe all hoods and incubators | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Wipe outside of dewars and dewars roller stands | EmbryoSafe, Oosafe, IVF Prime, H2O2. Record name and date of cleaning. |
| Check Generator maintenance records | Schedule generator maintenance |
| Air Filters | PM air handling system and replace HEPA and other filters. Life Aire |
| Replace VOC in line filters, Carbon filters on top of hoods | Coda® Xtra Inline® Filters Unique VOC removing filter technology should be replaced every 3-6 months. |
| Purified Water System | Specify types and purity of water used, PM must include CFU |
| Alarms, O2 alarms | Smart-Vue (thermofisher) CO2/temp monitor system for incubators, Oceasoft, TempGenius, Pharma Watch |
| Pipettes | Sterilize and Calibrate |
| Thermometers | Sterilize and Calibrate, InnoCal Solutions, a division of Cole Parmer |
| Gas manifolds | PM |
| Incubators | Pharma Watch, Smart-Vue (thermofisher) CO2/temp monitor system for incubators |
| Isolettes | Use a double loop of tape or suction cup to remove glass |
| Microscopes | Sterilize and Calibrate – PM, Kohler, Objectives, Lasers |
| Analytical Balance | PM |
| Anti Vibration Tables | https://www.newport.com/c/microscope-isolation-platforms |
| Hoods | PM, Sterilize and Calibrate: ENV Services |
| VOC Detectors | Graywolf PPB and RAE Systems PPB, VOC and particle meters from CooperSurgical |
| Lab Pens | The Maverick Embryologist’s list of favorites: Pilot G-2 Ultra Fine 0.38mm, 0.5mm, Pilot G2 0.7 mm , Small sharpie extra fine point, not ultra. Paper Mate ink joy gel 0.5, Tul Retractable Gel Pens 0.5mm Needle Point in blue, Zebra F-301 Ballpoint Stainless Steel Retractable Pen, Fine Point, 0.7mm, Black Ink, Pentel EnerGel RTX Retract, Pentel Energel Needle Tip 0.3. |
| Order Spare Parts | CI-2 micropipette connector Narashige for connecting to a glass micropipette, Mouth pieces at the IVFStore |
| 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 | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
The ART Compass platform makes managing space and supplies easy! In December we focus on tissue inventory, supplies management, and discard workflows! December is a great time for most IVF labs to prepare for the coming year’s IVF cycles by performing inventory of both embryos (visually comparing what is in the tank to what is in the cryostorage database) and reagents and supplies, disposing of embryos that are not usable or no longer needed out of tanks, deep cleaning the lab, organizing storage spaces, and archiving records to make space for the next year’s cycles!
What do the CAP guidelines say about “space and supplies”, ie. cryostorage, physical storage, and reagents traceability and inventory?
Specimen Storage and Disposition
| GEN.40506: Secured Specimen Storage | The original specimens (in the original container) and appropriately labeled aliquots are maintained in an appropriate manner when not in the possession of an authorized individual. |
| GEN.40507: Specimen Retention and Storage | Specimen retention and storage conditions are defined for each type of specimen tested by the laboratory using a chain-of-custody procedure. |
| RLM.08000: Specimen Handling | There is a system to verify and maintain the identity of the specimen throughout receipt, storage, processing, and disposition. |
| RLM.12400: Specimen Storage/Long-Term Disposition | There is a written procedure regarding the length of storage, informed consent and long-term disposition of cryopreserved gametes or embryos. |
| RLM.03975: Specimen Handling and Disposition | Records allow for the tracking of the disposition for gametes or embryos handled or stored. |
Records and Inventory
| GEN.40509: Secured Records | The chain-of-custody collection records, security logs, and testing records are retained for an appropriate period of time, no less than two years and following applicable laws and regulations, in a limited-access, secured (locked) area that is only accessible to authorized laboratory personnel. |
| GEN.61900: Inventory Control | There is an effective supply inventory control system in operation. |
| RLM.12000: Inventory | Records are available for the current inventory of all specimens that have been stored in its cryobanks. |
Embryo Cryostorage Inventory
A precise inventory is maintained for all embryos in storage by IVF laboratory staff. Once a year, the embryo inventory should be visually checked and confirmed with the embryo database. Patients who no longer wish to store their frozen embryos have several options. Frozen embryos may be discarded as medical waste. They may be donated for research studies, quality control or training of junior embryologists. When embryos are donated for lab use, they are thawed, studied scientifically, and then discarded after a few days. Typical research topics include new techniques for freezing or thawing embryos, new embryo culture methods, PGT-A or genetics studies and more!
Make some space! Embryo Discards
Embryo discards tend to pile up during the year. To discard frozen embryos, a consent form is typically signed (by both partners) and notarized or witnessed by IVF clinic staff. Many labs have a 30-60-day “cool down” waiting period, before at least two embryologists are needed to fulfill the patients’ wishes to discard embryos. Because multiple people are needed to properly locate the embryos in the storage tank and carefully confirm the identity, this is a time consuming a laborious process often superseded by the day–to–day demands of running an embryology lab. The embryologists will typically sign and date the consent form and other storage documents, attesting that they performed and witnessed the disposition according to the patients’ wishes and these should be kept permanently in the laboratory files. It is a good practice to provide written confirmation of the disposal of the embryos to the physician and patient chart.
Reagents and Supplies Inventory
Inventory control is vital to deliver quality IVF services. A carefully managed inventory ensures that the right quantities of reagents and consumables are available at the right time and place. It prevents waste from expired reagents (over-ordering), duplicate orders, or improper storage. All purchased supplies, reagents, and consumables should be included in the laboratory inventory. Information in the inventory should include lot number, date received, date put into use, expiration date, and special storage requirements. Inventory control management includes monitoring the physical storage environment (temperature, humidity, exposure to sunlight), keeping stock levels consistent with procedure numbers, conducting physical inventories, and disposing of expired products in a timely manner. You will want to ensure that the SDS and 510K folders in ART Compass are up-to date.
Tips to manage Space and Supplies
Designate a Place for Everything
Make sure everything in your lab has a specific place. Designate specific, clearly-labeled storage locations for each reagent or category of reagents to ensure that newly-delivered items can easily be found by all embryologists. Create a schedule to go through your reagents and remove expired and obsolete reagents from your storage space.
Label Everything
Establish a consistent labeling system that all embryologists and lab techs use to label aliquots and shared solutions. Don’t forget to also label shelves and cupboards, which can remind people of where items belong and help keep storage areas organized.
Create an Ordering Information Spreadsheet in ART Compass.
Keep an updated lab inventory and ensure all lab members update the LQMS module in ART Compass when receiving new items. A basic lab inventory spreadsheet can be created under “Documents and Forms” containing reagent names and ordering information (i.e. vendor, catalog number, price, etc.) Lot numbers and expiration dates may be included for good laboratory practice.
For larger IVF labs, create and maintain an ordering spreadsheet where embryologists can add items and quantities they need ordered for a given week. A designated member, such as the IVF supervisor, can then order these items in bulk for the entire lab.
One Month Schedule of Space and Supplies (Tissue Discards, Cryostorage, and Supplies Inventory) related IVF Lab QA Activities
The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”
| Check Consents and Disposition Directives, Perform Tissue Discards | Witnessing this procedure is non negotiable! Don’t forget, you can use the image archive function in ART Compass to record any part of this process., and permanently amend it to the patient record. |
| Prepare to Ship Tissues to long term storage. | Long term fertility preservation samples, and other types of samples for long term storage can be prepared now for transfer in the new year. Long term storage facilities include: Reprotech, Cryopoint, Fairfax Cryobank, California Cryobank, Ovation, TMRW. |
| Review Discard Policy and Process. Pull 10 discards to ensure the process has been followed. | A few good process points: Store tissue discards in a separate binder. Scan tissue discards into a separate (digital) folder. Don’t forget to mark tissue as “discarded” in cryostorage so the patient is not billed! |
| Review previous year’s cycle numbers, gas and dewar costs, and forecast needs for coming year. Review dewar and cryostorage options for coming year. | Calculate how fast you will fill up space: High capacity tank options are MVE 6000, Vitrostash among others. |
| Make or update a list of all supplies and reagents | Log into the web version of ARTC. Navigate to the white tab, LQMS. Update reagents list and then record lot #, expiration date, date into stock and into service. Use your phone’s camera to image product invoices, certificates of analysis and store them permanently. |
| Update the SDS folder in ART Compass with current safety data sheets. | Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products! |
| Count pieces in storage, check expiration dates, discard expired products. | Take an inventory of plastics, reagents, and other stocks! Discard expired reagents. |
| Update the 510K folder in ART Compass with products that have FDA approval. Discontinue use of products when a suitable approved device is available. | Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products! |
| Update Standing Orders for the new year. |
| 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 | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
This post is all about IVF patient satisfaction and HIPAA Compliance! We provide you with a month’s schedule of specific quality assurance activities to keep your IVF lab compliant with FDA Title 21 Code of Federal Regulations (CFR) Part 1271 and College of American Pathologist inspections. In the month of November, we will tackle CAP Checklist items GEN.20335- Customer Satisfaction and GEN.41303- Patient Confidentiality, and provide background on HIPAA and CAP requirements.
Remember to start each month’s quality audit off by opening the ART Compass mobile app or web platform and navigating to Surveys -> IVF Lab Quality Playbook and then marking each activity as “in progress” before assigning the monthly survey to your staff. When taking your quality systems from good to great, this is a GREAT way to perform a staff- training activity, and document and ensure quality audits are performed continuously throughout the year and not just before an inspection!
To satisfy CAP requirements, your IVF laboratory must measure the satisfaction of clients (e.g., healthcare providers, patients, referring laboratories, nurses) for IVF laboratory services every two years (minimally). The laboratory must also ensure that internal and external storage and transfer of data maintains patient confidentiality and security. Written procedures must address patient confidentially during transfer of data to external referral laboratories or other service providers. This must include cloud based computing (eg, for storage of confidential data). Lastly, the IVF laboratory must audit compliance with the procedures at least annually.
Patient Satisfaction
The College of American Pathologists says “Satisfaction metrics are important for understanding the needs of clients to improve laboratory services. Experience has shown that surveys are more informative if they are conducted anonymously and allow for open ended comments. The sample size should be adequate. A numeric satisfaction scale allows for calculation of statistics.”
Is your IVF lab following these recommendations for IVF patient satisfaction?
Is your IVF patient experience data actionable?
Staying on top of patient service issues is challenging, even with a well-equipped patient experience team. Most healthcare organizations use traditional paper surveys to track and monitor patient satisfaction metrics, but cutting-edge IVF Practices, healthcare administrators, and chief experience officers need real-time insights that are tied to patient experience goals. IVF clinics often operate on the narrowest of margins, which means losing even one patient over poor customer service is one too many! Complicating matters, most IVF clinics still use traditional paper surveys to track and monitor patient satisfaction metrics, putting them at a huge disadvantage in terms of identifying service recovery opportunities. Some IVF clinics may even intentionally make it difficult or unappealing for the customer to provide feedback with inaccessible surveys that are difficult to access or time consuming to fill out.
The ART Compass platform makes it easy for patients to provide real-time feedback — and even easier for fertility doctors (reproductive endocrinologists and infertility specialists or REIs) to improve service and IVF patient satisfaction based on this feedback. The ART Compass patient app includes intake forms, satisfaction surveys, and other types of surveys for patient education and shared decision making with physicians. Critically, this shifts the focus onto the patient and promotes a culture of service excellence.
The goals of patient satisfaction are;
Higher patient satisfaction and loyalty
Staff see how better experience impacts their role
More informed patient decision-making
Enable continuous improvement
Leverage evidence-based frameworks
HIPAA Compliance
Showcase your comprehensive commitment to healthcare data security with the ART Compass platform!
What is HIPAA and what is its purpose? HIPAA, the Healthcare Insurance Portability and Accountability Act, was signed into law on August 21, 1996. HIPAA’s overarching goal is to keep patients’ protected health information (PHI) safe and secure, whether it exists in a physical or electronic form. HIPAA was created to improve the portability and accountability of health insurance coverage for employees moving between jobs. HIPAA was also created to deal with waste, fraud, and abuse in health insurance and delivery of healthcare, as well as to promote the use of medical savings accounts, provide coverage for employees with pre-existing medical conditions, and simplify the administration of health insurance.
HIPAA’s goal is to keep patients’ protected health information (PHI) safe and secure, whether it exists in a physical or electronic form. If your company stores or processes any sort of PHI, you must be HIPAA-compliant. To become HIPAA-compliant, your company must establish clear policies and procedures for how you manage PHI. The HIPAA Privacy Rule requires all Covered Entities to have a signed Business Associate Agreement (BAA) with any Business Associate they engage with that may come in contact with PHI. Every IVF Lab has risks. Take some time to identify the unique risks for your IVF Lab and the patients whose PHI you process, describe their cause, and outline steps you’ve taken to lessen their potential impact.
Your IVF Lab will want to develop and implement a system for tracking policies, processes, procedures, documents, and related compliance materials. Your goal is to maintain compliance with HIPAA’s various component elements, to track any changes in ongoing HIPAA regulations, and to establish and maintain organizational processes for gathering compliance metrics.
Achieving HIPAA compliance isn’t a matter of proving the IVF lab’s adherence to a single static standard. HIPAA’s rules and requirements are intentionally broad and flexible to accommodate the range of types and sizes of covered entities and business associates that create, access, process, or store protected health information (PHI), and that must thus comply with HIPAA.
The ART Compass HIPAA Promise
Cloud environments are widely used across the United States to store PHI. At ART Compass, we only use Amazon Web Servers and products that are HIPAA compliant, Amazon provides extensive documentation for their HIPAA Compliant products.
There are many features built into ARTC for security- for example the “admin” account type provides Human Resources functions to immediately cut off staff access in the event of untimely separation. We also require that laboratory staff accounts to be accepted by the IVF lab director, and all email accounts must be verified. Our mobile apps leverage smartphone biometric technology- either thumbprint or Face ID, couples with “automatic timeouts” to further ensure privacy.
On the patient app side, patients will invite their own partner to join the medical record. A “One Time Password” (OTP) is sent to the partner via email, which must be authenticated by adding the email of the patient. Additionally, we provide a “separate records” feature in the event a couple must separate their medical records.
ART Compass sends data to the database using the REST API. The REST API was developed with the laravel framework. Protecting patient data at this point of transmission has been identified as a critical factor, so for this we use the “Passport authentication” method in laravel to authenticate the information, while avoiding security threats during data transfer. Statistical reports will also be visible in the administrative panel, access to which is controlled by login and authentication that has also been developed in the laravel framework.
The ART Compass Database is also protected with encryption techniques so that the raw values of the database cannot be decoded, including passwords. A MySQL database provides security by default, and data is transferred using “Passport” as an authentication technique allowed by HIPAA.
We provide a standard Business Associate Agreement for compliance with HIPAA Rules and Regulations (in your app under Settings -> Legal Agreements).
One Month Schedule of Patient Satisfaction and HIPAA related IVF Lab QA Activities
Start each month by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” button. This will document both continuing education and quality assurance activities.
| Proctor patient satisfaction surveys | Easily collect data with the ART Compass Patient App! |
| Compile results of surveys and distribute to relevant departments | Review positive and negative feedback. Define actionable goals, |
| Review incident or occurrence reports relating to HIPAA compliance | Ensure that staff know what constitutes a HIPAA breach, and how to document and report a breach. Quality systems should track security incidents, document, and report all breaches. |
| Referral Providers Satisfaction Surveys | Survey the Physicians who refer patients to the IVF practice. Do they have any valuable feedback to ensure high levels of patient care? |
| Review the U.S.Dept of Health and Human Services Office for Civil Rights Audit Protocol | Perform a readiness assessment and evaluate your IVF lab’s security processes. https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol/index.html |
| Schedule annual HIPAA training for all employees. | Distribute HIPAA Policies and ensure staff read and attest to their review. (you can use ART Compass to document yearly policy sign off activities. |
| Assess HIPAA Knowledge with the ARTC HIPAA Survey. | Assign staff the HIPAA Compliance survey (continuing education) to document employee processes, training, and attestations |
| Build a year-round risk management program to continuously assess risk. | Understanding the ins and outs of HIPAA compliance means understanding the costs or non-compliance and integrates continuous monitoring to manage the risks of non compliance. |
| Occasionally, contractors (ATime or Puah) will have access to patient data. | Ensure that any contractors have signed a BAA or NDA. |
| Institute an annual review process, with the ARTC IVF Lab Digital Playbook! | Annually assess compliance activities against HIPAA rules, and updates to HIPAA. |
| 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 | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
Staff Quality Assurance
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.
Staff Management
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.
ART Compass Features
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 | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August |
September is a great time to perform an FDA Compliance quality assurance audit in your IVF Lab!
This blog post will provide you with a month’s schedule of specific quality assurance activities that will keep your IVF lab compliant with FDA Title 21 Code of Federal Regulations (CFR) Part 1271 and College of American Pathologist inspections. It will also provide background on FDA and CAP requirements.
FDA requires prospective egg and sperm donors to be tested for HIV, Hepatitis B and C, chlamydia, and gonorrhea, and for stored embryos, eggs, and sperm to be labeled so they don’t get mixed up. The FDA has the power to inspect and shut down IVF labs if they don’t meet the legal requirements.
Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps). Any establishment that performs one or more manufacturing steps for HCT/Ps (recovery, processing, storage, labeling, packaging or distribution of products) must register with FDA and list their HCT/Ps in accordance with Title 21 Code of Federal Regulations (CFR) Part 1271.
Reproductive HCT/P donors are required to be screened for risk factors that may increase the chances of transmitting a communicable disease.
Donor screening consists of reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. These records include a current donor medical history interview to determine medical history and relevant social behavior, a current physical examination, and treatments related to medical conditions that may suggest the donor is at increased risk for a relevant communicable disease.
FDA Donor HCT/P Eligibility Determination: 3 Necessary Factors
Donor screening must document three items: donor medical history (ie risk factor assessment), physical exam and review of other relevant medical records, and donor infectious disease testing. After those items are reviewed by a physician or responsible person, a donor eligibility determination can be made. Donors can be deemed “eligible” for anonymous donation, or “ineligible” (and therefore the donation can only be directed, not anonymous). An ineligible directed reproductive tissue donor can provide semen, oocytes, or embryos, to a specific recipient, and who knows and is known by the recipient before donation, provided they are counseled appropriately and sign a waiver.
What is the IVF lab’s responsibility for maintaining FDA compliance?
Both FDA and CAP have specific requirements for IVF labs to follow. The IVF laboratory must be registered with FDA and have a procedure for reporting device-related adverse patient events, donor records must include a statement of eligibility or ineligibility and a summary of the records used to make the donor-eligibility determination, and there must be a written procedure for investigating donor infections or adverse events after reproductive donor cells/tissues are received or implanted.
Donor cells/tissues must be labeled with the following information in accordance with the intended use:
- Unique identification code
- Description of the type of cells/tissue(s)
- Expiration date (if any)
- Warnings (if any)
- Name and address of the establishment that made the eligibility determination and made the cells/tissue(s) available for distribution
Furthermore, for testing performed by clinical lab staff in Endocrinology or Andrology, prior to clinical use of each modified FDA-cleared or approved test and laboratory-developed tests (LDTs), the laboratory must perform a validation study and prepare a written assessment of each of the following test method performance specifications. Whenever available, reagents and supplies used in the collection, processing and cryopreservation of gametes and/or embryos should be cleared or approved by FDA for human use.
Lastly, the entire staff should be competent in FDA related skills and knowledge, and the IVF laboratory director or designee must interact with agencies FDA, as appropriate, for laboratory-related matters.
| FDA Related CAP Requirements | |
| GEN.20351: Adverse Patient Event Reporting | |
| RLM.12455: FDA Registration | |
| RLM.12510: Donor Cells/Tissues Labeling | |
| RLM.12587: Donor Infection/Adverse Events Investigation | |
| DRA.11450: Director Responsibility – Interaction with Government or Regulatory Interaction | |
| COM.40350: Validation of Test Performance Specifications | |
| RLM.03480: FDA-Cleared/Approved Reagents and Supplies |
One Month Schedule of FDA related IVF Lab QA Activities
Start each month by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” button. This will document both continuing education and quality assurance activities.
| Create or update a schematic map of all tank or canister eligibilities | Post up to date schematic in tank room(s). Download our editable template here! Tank-Schematic-1-1. |
| Review Tissue in Donor Canisters/ Tanks | Move all eligible donors to a single canister or tank. Update cryo records and log books. |
| Separate Sperm and Egg Bank Donor Binders | Particularly review shipping records to ensure that when donor tissue is received it is located in the correct binder, tank, and canister. |
| Take the FDA Survey in the ART Compass app and assign survey to staff | Review competency results and assign any needed remediation. Download the free ART Compass app Apple App Store: https://itunes.apple.com/us/app/art-compass/id1442048939?mt=8 Google Play Store: https://play.google.com/store/apps/details?id=com.artproficiencyapp |
| Update FDA Cryopreserved tissues eligibility forms | Copy language directly from HCTP and replace out of date language. |
| Review Summary of Records forms | Update out of date language by reviewing FDA Warning Letters (search for “fertility”). |
| Review Donor Risk Checklist / Questionnaire for updated risk questions | Update out-of-date language by reviewing FDA Warning Letters (search for “fertility”). |
| Review Requisitions for tissue type – anonymous, directed donor, and for future GC | Correct sperm freezing, egg cryo, and IVF requisitions so that IVF Lab can put an accurate FDA Cover sheet or sticker with each cryo record. |
| Review FDA eligibility form or stickers with each cryopreserved tissue by randomly selecting 10 GC transfers, 10 Egg Donor Embryos, and 10 Sperm Donor Embryos | Hold a staff meeting to ensure that each FDA eligibility status’ are used correctly. Goal of 100% compliance. Document staff/ lab meeting. |
| Review one full binder of sperm records and one full binder of embryo records for presence of FDA Eligibility sheets or stickers. If missing more than 3 per binder review all binders. | Replace or correct any FDA Eligibility sheets in each binder. |
| Read and sign off on all FDA related policies and procedures | Document each person for each Policy and Procedure. Assign them to staff and records annual sign offs in the ARTC Document control system. |
| Read FDA Warning Letters for fertility clinics. | Discussion deviations in a lab meeting and document meeting. |
| Review all tests and devices used and check for new FDA approved products. | Still using unapproved tests or devices? Are there any new tests of devices that can replace the unapproved ones? |
| Review any FDA reportable adverse donor or device events | Perform a Root Cause Analysis to determine the cause of any incidents. Notify the Laboratory Administrator and the Laboratory Director of the findings. Complete FORM FDA 3500 either in paper format or online at www.fda.gov/medwatch/report.htm |
| IVF Lab Director Responsibilities | Create a folder with evidence of compliance, such as records, reports, or responses to FDA. Make sure to notify FDA of any change in directorship! Update FDA Registration menu. |
| Audit companies that perform any manufacturing step for the IVF laboratory | Check the FDA website for current registration, possible FDA actions against contractors, and patient comments. Take action on any notification of defects or issue with supplies that may affect patient care and document actions. |
| Hold Mock FDA Inspection. | Are you ready for FDA to show up at your IVF Clinic? Review electronic medical records of donor tissue recipients and “provide recommendations” in a mock inspection. |
| 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 | General IVF lab CAP Inspection Preparations |
| April | |
| May | |
| June | |
| July | |
| August | |