Pioneering Precision: How Fertility Providers are Working Towards Reducing Errors in the IVF Lab

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BY IRH STAFF

In recent years, there have been dramatic changes in ART practice. As a result, operation of the IVF laboratory has become increasingly complex. With increased complexity comes increased risk.1 For couples navigating the challenging journey of infertility, concerns about human errors in the IVF lab have also emerged.2

Addressing these concerns involves rigorous safety measures and technological advancements. As the demand for improved transparency and patient engagement grows, fertility providers are stepping up to demonstrate their commitment to reducing errors in the IVF lab.

We spoke with leading professionals in the fertility field to explore the steps being taken to decrease the probability of error occurrence in all stages of IVF.

HOW ARE OTHER IVF LABS PROTECTING THEIR SPECIMENS? SURVEY RESULTS UNLOCKED

In recent years there have been dramatic changes in ART practice. As a result, operation of the IVF laboratory has become increasingly complex. With increased complexity comes increased risk.1

CooperSurgical’s published survey results2 reveal how the RI Witness? system may help address common challenges facing IVF clinics today, such as:

• Managing increased patient demand
• Addressing staff training, shortages, and retention challenges
• Meeting heightened patient expectations
• Adapting to changing demands with customized offerings
• Coordinating and maintaining standards across multiple clinics
• Navigating complex reporting and auditing requirements

Get instant access to the survey results.

1. Alikani,et al., (2014). Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care. Fertility and Sterility, 102(5), pp.1350-1356.

2. Lynch, Di Berardino, Desai. (2022) Impact of the use of RI Witness electronic witnessing system on the IVF laboratory staff and patient experience. Fertil Steril. E329, P-522.

Insights from Industry Experts

Michael Baker, Lab Director from Inception, emphasizes that serious errors in the IVF lab are rare. "The IVF laboratory’s thorough quality management systems are designed to prevent and detect laboratory errors of every level," Despite the rarity, the goal remains to eliminate even the simplest mistakes. "Our quality improvement approach aims to reduce the frequency of even the simplest typo," he adds.

When significant errors do occur, particularly those involving mismatched gametes or embryos, the consequences can be severe.3-6 Baker outlines the critical response process: "A response typically involves immediate investigation, root-cause analysis, corrective action implementation, and follow-up," If a mismatch is detected, a thorough review of the patients’ medical record is performed, and genetic analysis aids in the investigation and resolution. “Ideally, the mismatch is caught before irreversible action has occurred," he notes.

The Evolution of Electronic Witnessing

EWS (Electronic Witnessing Systems) were developed to mitigate the risks associated with human error.7 Baker recounts the evolution from traditional double witnessing, where two trained individuals confirm patient identifiers, to advanced technology-assisted witnessing solutions. "The complexity of the embryology laboratory grew over the decades, making it clear that we needed a technology-assisted witnessing solution," he says.

Jason Au, Regional Lab Director from PCRM, highlights the importance of EWS in maintaining an objective confirmation of sample identity. "Electronic witnessing provides an objective confirmation of the sample's identity. It also ensures a chain of custody and maintains an electronic record of the process." This system aids in the investigation of potential patient inquiries regarding errors.

Today, systems such as CooperSurgical’s RI Witness? system help safeguard patients’ samples during the ART process within the fertility lab – from start to finish. RI Witness uses Radio Frequency Identification (RFID) tags to ensure continuous tracking of samples, reducing handling time by approximately 50%8 and providing a comprehensive audit trail. “RI Witness tags each container with an RFID tag, providing a passive system that alarms without user action before any irreversible mistake can be made," Baker notes.

Integration and Benefits of RI Witness

The integration of electronic witnessing with lab processes is a significant advancement. Au emphasizes the strength of the RI Witness system in providing active and objective witnessing of samples. "When two samples with RFID tags enter the sensor/work area, the system immediately confirms their identification and checks for a match," he says. This system's efficiency and reliability contrast sharply with barcode systems that rely on manual scanning. "If the user fails to scan the barcode, the system becomes ineffective," Au points out.

RI Witness helps build confidence, efficiency and trust. Baker mentions the peace of mind it provides to embryologists, physicians, and patients. "It is hard to quantify how many errors have been prevented by the system, but the security is invaluable," he says. Additionally, the system allows the user to have a complete chain of custody visibility throughout biopsy, cell tubing, vitrification and warming.

Charlotte Khoury, Scientific Director at HRC Newport, shares her experience with RI Witness. "As the Lab Director, it gave me peace of mind that no way an egg or sperm is mixed," she says. Khoury also notes that the RI Witness alert system even prevents near-mismatches, further enhancing lab safety.9. "The RI Witness system will also alert us of a possible ‘mismatch’ even if discarded dishes are sitting too close or off to the side to the RI Witness RFID readers," she explains. "If it alerts us even with a near mismatch, it will prevent us from a true mismatch."

Widespread Adoption and Future Prospects

The adoption of EWS such as RI Witness is seen as essential by industry professionals. Baker emphasizes this point. "Every laboratory should have an electronic witnessing system to help their embryologists, providing everyone a peace of mind that cannot be understated."

Baker asserts the commitment to such systems reflects an IVF lab's dedication to patient safety and staff well-being. "Embryologists are recognizing the differences between the laboratories that have invested in electronic witnessing and those that have not, both as a measure of their commitment to patient safety and the embryologists’ well-being," he adds.

Au echoes this sentiment, emphasizing the importance of such systems in maintaining high-quality and safe practices. "An electronic witnessing system demonstrates that the lab and its director are innovative and have an unwavering commitment to high-quality and safe practices," Au states.

In addition to its core functions, Security and Tracking – RI Witness continuously monitors and records all activity at all workstations, where samples are moved from one dish to another. "The development of individual embryo-level tracking, integration of genetic results, and shipping/discard functionality will elevate patient safety and process efficiency to new heights," Baker predicts.

As fertility providers work towards a future with minimizing errors in the IVF lab, systems including RI Witness? can help in this effort. These technologies not only reduce the risk of errors9 but also enhance workflow efficiency8 and improve staff well-being.10

Want to know how your peers in the IVF lab are using their witnessing system? Just click here to get an instant PDF of the survey results.

References:

1. Alikani,et al., (2014). Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care. Fertility and Sterility, 102(5), pp.1350-1356.

2. Forte et al. (2016). Electronic witness system in IVF-patients perspective. Journal of Assisted Reproduction and Genetics, 33, pp.1215-1222.

3. Sakkas et al., (2014). To err is human, even in IVF: A review of non-conformances/errors in 31,715 in vitro fertilization (IVF) treatment cycles. in Human Reproduction (Vol. 29, pp. 29-29).

4. News, A.B.C. (n.d.). Couple sues fertility clinic alleging wrong sperm was used to inseminate wife. [online] ABC News. Available at: https://abcnews.go.com/GMA/Wellness/couple-sues-fertility-clinic-alleging-wrong-sperm-inseminate/story?id=97364816.

5. Staff, T. (2022). Probable biological mother in embryo mix-up: ‘I wish I could hug the other woman’. [online] The Times of Israel. Available at: https://www.timesofisrael.com/probable-biological-mother-in-embryo-mix-up-i-wish-i-could-hug-the-other-woman/ [Accessed 26 Jun. 2024].

6. D, R. (2023). Descubre que no es el padre biológico de su hijo tras un ‘error’ en la fecundación asistida en el Hospital Puerta del Mar de Cádiz. [online] Diario de Cádiz. Available at: https://www.diariodecadiz.es/cadiz/Descubre-no-padre-biologico-hijo-error-fecundacion-asistida-Hospital-Puerta-Mar-Cadiz_0_1776722585.html [Accessed 26 Jun. 2024].

7. Rienzi et al.,(2015). Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF. Reproductive Biomedicine Online, 31(4), 516– 522. 31(4).

8. Patel et al., (2013). An investigation into the efficiency of RFID electronic witnessing compared to manual witnessing. The Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital. Figure 4.

9. Sterckx, et al.(2023). Electronic witnessing in the medically assisted reproduction laboratory: insights and considerations after 10 years of use. Human Reproduction, 38(8), pp.1529-1537.

10. Lynch, Di Berardino, Desai. (2022) Impact of the use of RI Witness electronic witnessing system on the IVF laboratory staff and patient experience. Fertil Steril. E329, P-522.

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