Witnessing and protocol deviations in the in vitro fertilization and andrology laboratory: a committee opinion

Contemporary in vitro fertilization (IVF) cycles are complex and involve multiple procedures and protocols in the laboratory. Minimal standards for laboratory staffing levels in relation to clinic size and cycle volume have been published elsewhere and are not covered in this document (1). For clarity, this document will use the terminology ‘‘protocol deviations,’’ which may or may not result in events more broadly described as errors or nonconformances. Although appropriate staffing levels help maintain safety and efficiency in the laboratory, specific protocols are required to ensure there is robust witnessing at key misidentification risk points during an IVF cycle to minimize the risk of error. The importance of disclosure of protocol deviations involving gametes and embryos has been described elsewhere (2). To address cases of a protocol deviation, it is imperative that there be a policy and procedure in place allowing the following documentation: a description of the type of protocol deviation, the severity of risk, and the appropriate plan of action. This document provides a framework and guidance for each IVF laboratory to establish its own robust witnessing and protocol deviation reporting policies and procedures. At all times, prompt ethical and nonpunitive reporting of protocol deviations should be strongly encouraged in the laboratory and as part of the clinic culture.

CURRENT PRACTICE OF WITNESSING AND ACCREDITATION REQUIREMENTS

Patient samples in the laboratory should be continuously identifiable and traceable. The IVF laboratories are subject to potential human errors that can occur at multiple stages in the preparation (preanalytical), performance (analytical), and reporting (postanalytical) of every patient’s IVF cycle. As embryo culture, cryopreservation, and genetic testing have evolved, so has the complexity and volume of the daily manipulations of gametes and embryos. Therefore, today’s assisted reproductive technology (ART) laboratory must balance the evolving science with sound administrative processes that incorporate diligent witnessing procedures to reduce and prevent daily variables and human errors, respectively.

The IVF clinics in the US are required to maintain an embryology laboratory that is accredited by either the College of American Pathologists (CAP) or The Joint Commission (TJC). Accrediting agencies have specific requirements for written orders from physicians to the laboratory regarding patient sample management, patient sample identification, sample traceability, witnessing of misidentification risk points, and documentation in case of protocol deviations. Documented and detailed protocols outlining witnessing practices have become the most important quality assurance process implemented to reduce major human error and protocol deviation events. These procedures also add liability protection for all parties involved, whether performed manually or electronically. Converse to quality control measures, which focus on avoiding equipment malfunctions and laboratory performance, witnessing is focused on the mindful detection of a human error or protocol deviation.

MANUAL AND AUTOMATED WITNESSING

Critical procedures in the IVF laboratory must be witnessed by a second person (manual witnessing) and/or by a certified electronic witnessing system (EWS). Witnessing should occur whenever a sample is moved from one container (specimen cup, dish, tube) to another to ensure a correct chain of custody. Critical steps along the IVF procedure that necessitate witnessing include:

1. Oocyte collection and preparation
2. Sperm collection and preparation
3. Mixing of sperm and oocytes (conventional IVF insemination and intracytoplasmic sperm injection [ICSI])
4. Moving embryos between dishes
5. Biopsy of embryo
6. Cryopreservation of embryos, oocytes, and/or sperm
7. Thawing/warming of embryos, oocytes, and/or sperm
8. Transfer of embryos into a patient
9. Discarding of gametes or embryos

The witnessing records must identify the following: who manipulated the samples, either by initials (manual) and/or individual login (electronic), the time the procedure occurred, and who witnessed/verified the procedure. A manual witness should be familiar with the laboratory setting and the relevance of the task. Manual witnessing requires focus and attention to detail of the task at hand. Witnessing must occur in real time before a sample is moved or manipulated. Although manual witnessing will always require two personnel, EWS may allow an embryologist to work alone for some procedures. It would, however, be imperative that certain critical steps are validated with a second manual witness, such as in steps 3 and 8 above, mixing of the gametes at insemination or ICSI, and identification of embryos/patient before loading the transfer catheter. If an EWS is used, appropriate selection, validation, training, and continued auditing of witnessed processes are required. The EWS consists of barcoding and/or radio frequency identification (RFID) tagging of plasticware; hence, any external components of the EWS that meet plasticware must be toxicity tested.

Witnessing, either manually or by EWS, must take place before gamete/embryo movement/manipulation to prevent an error from occurring. Staff must be knowledgeable of the importance of following the standard operating procedures of the EWS. All no-matches between samples must be investigated, as these represent ‘‘near-misses.’’

BASIC RULES OF TRACEABILITY OF REPRODUCTIVE SPECIMENS

• Laboratories must develop a system to accurately identify, trace, and locate gametes (oocytes and sperm) and embryos during each step of the IVF process, including at minimum two patient identifiers on all materials. These must be satisfied by manual and/or electronic labeling systems.
• Personnel must be trained in the verification and witnessing procedures. Competency must be evaluated at least annually.
• Each patient must have a unique identifier (e.g., medical record number [MRN]) that can be used to trace all gametes, embryos, clinical data, bloodwork, consent forms, and other documents.
• Each patient’s treatment cycle must have a unique identifier (i.e., cycle accession number).
• All witnessing procedures must be documented in the lab oratory record, indicating the procedure, operator’s, and witness’s initials, date, and time.
• Before any gamete procurement procedure (oocyte retrieval, sperm collection) or embryo transfer/intrauterine insemination, a ‘‘time-out’’ procedure should be implemented just before the procedure takes place. Each patient should be asked to state their full name and date of birth (DOB), which should be cross-checked against the patient’s arm band, coded cycle card/badge, or identifying documents (e.g., driver’s license, passport), as well as all paperwork corresponding to the procedure. The patient, physician, and staff member(s) each serve as witnesses in this case, and it is advisable to have them sign the witnessing document.
• All devices/containers containing gametes/embryos must be clearly and permanently labeled with Specimen IDs: patient’s and partner’s full name and at least one other identifier (DOB, MRN, donor code), cycle identification code (accession #, cycle ID #), type of tissue/cells contained, and date. Identification on all labels must be in line with that mandated by accrediting agencies, such as CAP or TJC. A national labeling convention would facilitate future sample movement between laboratories.
• Any relevant material coming into contact with gametes/ embryos from gamete procurement to final disposition (culture and handling media, protein, polyvinylpyrrolidone [PVP], oil, hyaluronidase, cryo devices, cryo media, embryo transfer [ET] catheters, etc.) should be logged so that lot numbers and product type can be traceable in case of recalls or necessity to follow up with any deviations from key performance indicators.
• All patients’ gamete and embryo handling procedures must be performed in separate, sterile pipettes, flexipettes, and micropipettes. Avoid any chance of possible cross-contamination of specimens.
• Gametes/embryos from different patients should not be processed in the same workspace at the same time, or simultaneously, if space is inadequate.
• Specimen ID must be verified each time the gametes/embryos are handled (moved to a new incubator, dish, or device), with a check of the dish/device by a second person (manual witness) and/or electronic ID system at each critical step.
• Operator (embryologist performing the procedure) and witness should document the date and time of each event.
• Avoid interruptions/distractions during critical procedures and witnessing.
• A checklist is useful for quickly reviewing critical steps of the workflow and minimizing errors. The operator and witnessing staff should review and attest with initials/signatures when performing major steps indicated on the checklist (time-out, patient/embryo ID before transfer, etc.).
• Laboratory must have comprehensive protocols delineating the policies and procedures described above.

MANUAL VS. EWS WITNESSING

Both electronic and manual witnessing systems can have drawbacks (3). Manual witnessing often requires an extra person to be drawn into the working environment and can draw others away from their roles. Therefore, it may unintentionally create a distraction. It also adds additional witnessing paperwork to an already complicated working environment. The introduction of EWS, as a backup system, has been argued to create involuntary complacency because of automaticity of checking. Inadvertent lowering of attention levels could happen if undue confidence is developed in EWS. Finally, the use of EWS could provide IVF laboratories with the confidence to opt to operate with one person, even though this would not be a favored option. This in itself may lead to protocol drift and a lack of oversight.

TRACEABILITY OF REPRODUCTIVE SAMPLES

There must be a clearly documented and witnessed chain of custody for every gamete/embryo from procurement through all processes until final disposition. There must be no gaps in this chain. The witnessing protocol may include the recommended chain-of-custody steps described in Table 1, with additional safeguard examples provided in Table 2. The ultimate aim is to ensure that documentation is in place that can follow each step and trace back to any protocol deviations if a problem is encountered.

TERMINOLOGY

Accession number: Cycle identification code.

Cross-check: Operator or witness checks made to be sure that ID information for patient/partner, containers, dishes, and paperwork match.

Precheck: Before gametes/embryos are moved to a new container, the specimen ID is cross-checked by operator and witness.

Double-check: Before the procedure commences and while the operator is performing the procedure, the witness observes and cross-checks the specimen ID.

Specimen ID: Patient’s and partner’s full name and at least one other identifier (DOB, MRN, donor code), cycle identification code (accession number), type of tissue/cells contained, and date. Given the increase in movement of gametes/embryos between clinics, a standard labeling system may need to be adopted in the future.

Operator: Embryologist/andrologist performing the procedure.

Witness: Person (embryologist, patient, nurse, or other person) or EWS (when appropriate) besides the operator verifying the ID of patients or specimens that is familiar with protocols.

Time-out: Nurse or other staff person reads off patient identification and procedure information to all staff who will participate in a procedure involving the patient (intrauterine insemination [IUI], oocyte retrieval, ET).

Full-stop: If any information given at the time-out does not correlate with the information that the team has concerning the procedure, the procedure is halted until the misinformation is cleared up.

Scheduled frozen gamete or embryo discard

Before any discard, the dispositional documentation from the patient, most importantly consent and agreement forms, must be reviewed by the staff member performing the discard and witnessed by senior laboratory staff and signed off by the responsible clinician as recommended by American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive Technology (SART) (4). Discards can be scheduled on a regular basis to regulate workflow and streamline the process. All discards must be performed in tandem with a witness. This procedure would be performed manually, as the current EWS may not be refined enough to allow for the nuances involved in discarding gametes or embryos.

Typically, when discarding gametes or embryos, a patient’s cryopreservation storage canes are temporarily relocated one at a time to a liquid-nitrogen (LN2) bath. Vitrified embryos thaw extremely rapidly and can be damaged or even destroyed if warmed above the temperature required to maintain water in a vitrified state (T_g = -120^◦C). It is therefore critical that the labeling of the cryopreservation storage cane is legible while submerged under LN2. Once the two unique patient identifiers are visible, the embryologist quickly and carefully removes the vitrification devices inside the cryopreservation storage cane, and although submerged in liquid nitrogen, the embryologist reads aloud the two unique identifiers on each device for the witness to hear. If specific, individual embryos from a patient are being discarded, then embryo numbers must be identified clearly and verified by a witness on the vitrification device and paperwork. The witness then performs ‘‘active witnessing’’ by also visualizing the patient identifiers on paperwork or electronic record, the cane, and each device, and verbalizing them aloud. Once confirmed as accurate, the devices may be discarded into biological waste. The inventory list should be updated accordingly, and embryologists should cross-check the inventory on the discard agreement to confirm appropriate samples are discarded. A note should be made in the patient’s electronic chart at the time of discard by the laboratory staff. The signed patient discard consent and agreement forms should be scanned into the patient’s electronic chart at the time of discard by the laboratory staff.

RECOMMENDATIONS OF MINIMAL REQUIREMENTS FOR IVF LABORATORIES TO DOCUMENT AND REPORT PROTOCOL DEVIATIONS

The IVF laboratories should conduct continuous assessment of risks within the IVF laboratory and actively identify areas and processes where protocol deviations may occur. Proactive measures for risk mitigation should be ongoing within all IVF laboratories. However, despite best efforts, protocol deviations are inevitable in any complex process, and IVF is not an exception (5–7). It is important to recognize that error prevention is a system issue, which requires a proactive approach to the detection and reduction of protocol deviation events. Therefore, it is the responsibility of the laboratory leadership to develop and maintain quality management systems (QMS) that set and maintain efficient processes for monitoring, investigation, and prevention of protocol deviations to assure patient safety and quality of care (2, 8). The QMS programs should be based on proven systems for error prevention, such as failure mode and effects analysis (FMEA) (8–10) or clinical safety board (CSB) (11) and cover all areas of the laboratory work where errors can occur. The QMS programs should address the process of reporting, recording, and monitoring of errors, as well as root cause analysis, corrective actions, and measures to prevent recurrence (8, 9).

Laboratories must have a system for continuous surveillance and monitoring of protocol deviations, on the basis of their type, area, severity, and frequency. Laboratory leadership should conduct regular audits of the protocol deviation data and trends and take proactive measures to reduce their frequency (12).

 

GRADING OF PROTOCAL DEVIATIONS IN THE IVF LABORATORY

Protocol deviations range in severity, from none/minimal to major. Table 3 provides a suggested grading system that laboratories may use when creating their own policies and procedures for reporting (7).

REPORTING OF PROTOCOL DEVIATIONS

The effectiveness of QMS is vitally dependent on the identification and reporting of all protocol deviations, including near misses, so that they may be properly investigated and analyzed. Laboratories should implement cryopreservation storage procedures and tools to identify, report, and record protocol deviations, (8, 9, 13). This process should be efficient, straightforward, and nonpunitive. For example, the ‘‘situation, background, assessment, and recommendation (SBAR)’’ clinical communication tool has been widely used in many areas of medicine and can be easily adopted for the multidisciplinary IVF environment (14). Additionally, there should be a process for reporting and recording protocol deviations identified through outside sources, such as complaints from patients, physicians, or nurses (12). There are different types of protocol deviations or nonconformances (errors) in the laboratory, as well as different degrees of severity. Of utmost importance is that a culture of reporting protocol deviations must be fostered and that staff must feel safe in reporting them. Without a culture of safety in making protocol deviation reports, corrective actions are limited, and greater harm could arise with more significant protocol deviations.

Some protocol deviations, such as a dropped dish or lost embryo, require immediate attention, whereas other protocol deviations, such as documentation errors, involve a review of the pertinent issues, which can take time. However, all protocol deviations should follow a systematic, defined procedure described by the following series of steps.

Once a protocol deviation is identified, a supervisor is generally the first person contacted to help and/or begin to review the issue. The supervisor may resolve the problem immediately, and depending on the severity of the error, there may be no further action taken. If further review is required or the protocol deviation is significant, the laboratory director or a department head and the medical director have to be informed of the situation. There must then be an investigation of the protocol deviation and then there are a number of possible actions that may be taken at this point. The final aim is to formulate a plan of action developed to both mitigate and prevent future protocol deviations.

If human error was involved, the embryologist(s) should be interviewed to find out what happened and how the error occurred. In the case of a significant error, the embryologist(s) will be asked to complete a written report on the protocol deviation/variance. If the embryologist has had other recent errors, they may be given a warning about their performance, or other action may be taken.

If the error involved equipment, it must be taken out of service and repaired or replaced as appropriate. In the case of a supply item such as a dish, media, or oil, the lot involved will be replaced, and an investigation will be initiated to determine whether the supplier should be notified and whether patients must be informed. A variance report has to be completed if the error was significant. In some cases, an error may be discovered after the fact because of a documentation mistake or a patient-reported concern. These situations often require extensive investigation to determine the root cause of the problem, and generally, a variance report should be filed.

A written variance report is completed when a deviation has a significant impact on a patient or has the potential to affect a number of patients. These reports include patient name(s), a description of the event, the department, and identification of the embryologists involved. These reports are written or filed electronically and sent to the laboratory director, department head, and risk manager. All reports must be acted upon immediately, but should also be reviewed at a scheduled quality improvement meeting. This may be monthly or quarterly. The risk manager will then coordinate any further internal action required and/or further follow-up communication with the patient(s). Regardless of the report timeline, it is imperative that when a deviation directly impacts any patient(s) care that any patient(s) affected be alerted as soon as possible or feasible. Any variance reports must be acted upon, and any actions taken (even inaction) must be documented and reported to both the reporter of the variance and the department head. Extensive documentation of any changes implemented is required, as is a follow-up review to ensure that the improvements have prevented similar protocol deviations.

Each protocol deviation report, regardless of severity, should be investigated and addressed in a systematic way to determine the cause and prevent recurrence. It is of critical importance that each deviation must involve open communication to those affected by the deviation, including timely and transparent communication to staff, the patient, or patients. Such investigations involving staff should not be punitive or threatening, but rather focus on culture, system improvement, teamwork, and organizational and behavioral learning (15). All nonconformance events require formal root cause analysis, including but not limited to identifying the problem, mapping the process, finding root cause, developing solution(s), implementing solution(s), surveillance, and effectiveness assessment (10, 12, 16). As laboratories are being reorganized into corporate networks, the culture is moving to data-driven reporting and mitigation of liability through robust surveillance and assessment.

CODIFYING PROTOCOL DEVIATIONS AND DEVELOPING KEY PERFORMANCE INDICATORS

The QMS program should carefully analyze all areas of risk within the laboratory and identify areas where protocol deviations may occur. Laboratories must then develop and monitor key performance indicators (KPIs) for all phases of the IVF process by regularly comparing performance against targets defined by the laboratory (7, 17, 18). Laboratory protocol deviations should be classified on the basis of their impact, type, and areas in which they occur (18).

It is important to consider the severity and impact of each nonconforming event (17, 19). Protocol deviations can be codified on a scale, from the most severe sentinel events to near-misses (See Table 3 for example) that have not reached the patient but present excellent opportunities for learning and improvement of the QMS program. Laboratories should focus most efforts on the prevention of the sentinel events, such as massive loss of the cryopreserved inventory, transferring misidentified embryos, or using wrong semen specimen for insemination, and develop systems that help minimize and hopefully eradicate the potential for such catastrophes (19). Effective preventive measures in IVF include backup systems, using checklists, timeouts, efficient handoffs, double witnessing, electronic witnessing, use of video cameras between the laboratory microscope and patient procedure room, reducing disruptions, physical separation of critical processes, color coding, and others (3, 10, 20–23). Commonly accepted systems of classification of laboratory errors are based on the phase of the laboratory process during which they took place (17–19).

Various areas of the ART laboratory process where errors may occur can be defined as media and dish setup, oocyte retrieval, semen/sperm processing, fertilization assessment, micromanipulation, embryo assessment, ET, cryopreservation, preimplantation testing, results reporting, quality control, instrument checks, etc. (17–19). Additional areas to monitor are occupational safety incidents, equipment malfunctions, Health Insurance Portability and Accountability Act of 1996 (HIPAA) incidents, Food and Drug Administration (FDA) compliance, and other general aspects of the laboratory practice (8). Nonconforming events can be further categorized into groups on the basis of the nature of the error (e.g., misidentification, handoff errors, omission errors, communication errors, reasoning errors, technical errors, etc.) (17–19).

NATIONAL REPORTING DATABASES

Both the Human Fertilisation and Embryology Authority (HFEA) and French Agence de la Biomedicine publish reports of protocol deviation incidents. The HFEA has published a series of reports on the number of incidents involving IVF clinics in the United Kingdom (24–26). They defined an ‘‘adverse incident’’ as any event, circumstance, activity, or action which caused or had been identified as potentially causing harm, loss, or damage to patients, their embryos and/or gametes, staff, or a licensed center. Recently, they have also separated protocol deviation reports to different sections and have published that in 2014– 2015 (0.169%) protocol deviations were related to the laboratory. Interestingly, the French Agency of Bio-medicine (27, 28) has also instigated a reporting mechanism aimed at documenting the safety and quality of ART (28, 29). Of the 489 incidents in the 2015 report, 125 were related to an IVF laboratory process; for example, hyperstimulation events were also reported. Of the laboratory events, 28.8% were serious incidents (n = 36). These were classified as serious adverse events, resulting in misclassification or loss of gametes, germinal tissues, or embryos with loss of total chance of procreation on the attempt or for the couple.

The development of similar databases (30) by societies such as Alpha Scientists in Reproductive Medicine (ALPHA), International Federation of Fertility Societies (IFFS), European Society of Human Reproduction and Embryology (ESHRE), and ASRM would allow incident reporting to be monitored independently and blinded, a process similar to that used in the aviation industry. Analyzing and reporting IVF laboratory protocol deviations can only be of benefit (7). Indeed, Kachalia (31) stated that ‘‘no matter how daunting the task, shining a light on errors shows a path to improvement.’’ Such databases would also allow independent tracking of protocol deviations related to particular protocols, procedures, and even equipment. This could serve as an early warning mechanism for identifying problematic areas, equipment, or techniques in reproductive medicine. Overall safety could be improved if this approach is taken (32), and it could be argued that IVF clinics would limit their risk exposure. This highlights the need to have universal definitions specifically related to the field of IVF.

FUTURE DIRECTIONS

Automation and semi-automation in the laboratory will facilitate risk mitigation if applied appropriately and monitored routinely. Additionally, national and international reporting databases with standardized definitions, labeling, and documentation of laboratory protocol deviations would be helpful to improve overall safety and minimize exposure to risk.

SUMMARY STATEMENTS

• Laboratories must establish robust witnessing protocols that, in combination with appropriate staffing, mitigate the risk of protocol deviations and improve patient safety.
• At all times, laboratories should have a QMS program in place to evaluate KPIs and potential sources of protocol deviations.

CONCLUSION

• A protocol deviation reporting flow chart is recommended and review of events is an essential part of a laboratory QMS program.

Acknowledgments

This report was developed under the direction of the Practice Committees of the American Society for Reproductive Medicine (ASRM) and Society for Reproductive Biologists and Technologists (SRBT), as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations. The Practice Committee and the Board of Directors of the American Society for Reproductive Medicine have approved this report. This document was reviewed by ASRM members, and their input was considered in the preparation of the final document. The following members of the ASRM Practice Committee participated in the development of this document: Clarisa Gracia, M.D., M.S.C.E.; Rebecca Flyckt, M.D.; Denny Sakkas, Ph.D.; Karl Hansen, M.D., Ph.D.; Tarun Jain, M.D.; Suleena Kalra, M.D., M.S.C.E.; Bruce Pier, M.D.; Denny Sakkas, Ph.D.; Belinda Yauger, M.D.; Torie C. Plowden, M.D., M.P.H.; Ryan Smith, M.D.; Mark Trolice, M.D., M.B.A.; Suneeta Senapati, M.D.; Robert Brannigan, M.D.; Amy Sparks, Ph.D., H.C.L.D.; Jared Robins, M.D.; Chevis N. Shannon, Dr.Ph., M.B.A., M.P.H.; Jessica Goldstein, R.N.; and Madeline Brooks, M.B.A., M.P.H. The Practice Committee also acknowledges the special contribution of Denny Sakkas, Ph.D.; Sangita Jindal, Ph.D.; Brent Barrett, Ph.D.; Rebecca Holmes, Ph.D.; Marina Gvakharia, M.D., Ph.D.; Mitchell Schiewe, Ph.D.; and Arthur Chang, Ph.D., in the preparation of this document. All committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest on the basis of the relationships disclosed did not participate in the discussion or development of this document.

CRediT Authorship Contribution Statement

Jessica Goldstein: Project administration, Writing – review & editing.

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