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Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF

      Abstract

      Traceability of cells during IVF is a fundamental aspect of treatment, and involves witnessing protocols. Failure mode and effects analysis (FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with witnessing protocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic witnessing system (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual witnessing system is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the witnessing process, identifying critical steps and planning changes in practice to enable safety to be enhanced.

      Keywords

      Introduction

      In IVF, several procedures are involved in the procurement, manipulation, evaluation and culture of gametes and embryos, all with different risk profiles and potential failures. In particular, critical steps that may involve mismatches of gametes and embryos include gamete collection, insemination by either conventional IVF or intracytoplasmic sperm injection, gametes and embryos allocation in tubes, dishes, or both, cryopreservation and embryo transfer (
      • Magli M.C.
      • Van den Abbeel E.
      • Lundin K.
      • Royere D.
      • Van der Elst J.
      • Gianaroli L.
      Committee of the Special Interest Group on Embryology. Revised guidelines for good practice in IVF laboratories.
      ). To minimize the risk of error during identification of patients and cell manipulation, an effective and accurate traceability system able to uniquely locate gametes and embryos during each step of the IVF procedure, from procurement to disposition, and vice versa, is mandatory. A proper identification system should also ensure that information on the main characteristics of patients, cycle and cells, together with relevant data related to products and materials coming into contact, should be provided continuously (Commission Directives 2004/23/EC; 2006/86/EC). Double-checking by a second operator (witnessing) is the main control measure used to avoid biological sample mis-identification.
      Witnessing involves different professionals from the operating theatre to the IVF laboratory (namely gynaecologists, embryologists, technicians, nurses and administrative staff), following precise standard operative procedures, and requires the team to undergo specific training. This approach, however, can result in the occurrence of human error owing to check omission, incomplete check, involuntary automaticity and non-contemporaneous checking (
      • de los Santos M.J.
      • Ruiz A.
      Protocols for tracking and witnessing samples and patients in assisted reproductive technology.
      ,
      • Toft B.
      • Mascie-Taylor H.
      Involuntary automaticity: a work-system induced risk to safe health care.
      ). Therefore, IVF is a particularly challenging technology involving a multidisciplinary team that must ensure quality and safety continuously.
      Although rare, mismatches have been reported in different centres worldwide (
      • Bender L.
      To err is human. ART mix-ups: a labor-based, relational proposal.
      ,
      • Liebler R.
      Are you my parent? Are you my child? The role of genetics and race in defining relationships after reproductive technological mistakes.
      ,
      • Spriggs M.
      IVF mixup: white couple have black babies.
      ). According to the Human Fertilisation and Embryology Authority, UK's independent regulator of fertility treatment, the risk of error between 2008 and 2009 was about 0.6% per cycle, and 332 incidents were registered out of more than 50.000 cycles carried out (
      • Human Fertilisation and Embryology Authority (HFEA)
      Code of Practice.
      ). The possible consequences of errors are either the partial or total loss of biological material when the mistake is immediately intercepted by the IVF team or, in worst cases, the transfer of embryos deriving from a mismatch. Any actions able to reduce these risks are of course advocated. Mandatory recommendations have been clearly formulated by the European Commission Directives (2004/23/EC; 2006/86/EC) and widely implemented in Europe. Each institution is requested to put in place its own traceability and witnessing system able to ensure safety. The Human Fertilisation and Embryology Authority has specifically recommended electronic systems, subject to a risk assessment, to minimize the risk of mismatches in IVF (
      • Human Fertilisation and Embryology Authority (HFEA)
      Code of Practice.
      ). Different alternative options have been developed: systems based on barcode labels (
      • Schnauffer K.
      • Kingsland C.
      • Troup S.
      Barcode labelling in the IVF laboratory.
      ), systems based on silicon barcodes that are added to sperm samples or attached to eggs and embryos (
      • Novo S.
      • Barrios L.
      • Santaló J.
      • Gómez-Martínez R.
      • Duch M.
      • Esteve J.
      • Plaza J.A.
      • Nogués C.
      • Ibáñez E.
      A novel embryo identification system by direct tagging of mouse embryos using silicon-based barcodes.
      ,
      • Novo S.
      • Mora-Espí I.
      • Gómez-Martínez R.
      • Barrios L.
      • Ibáñez E.
      • Such X.
      • Duch M.
      • Morad X.
      • Plaza J.A.
      • Nogué C.
      Traceability of human sperm samples by direct tagging with polysilicon microbarcodes.
      ) and systems based on radio frequency identification technology (RFID) (
      • Glew A.M.
      • Hoha K.
      • Graves J.
      • Lawrence H.
      • Read S.
      • Ah-Moye M.
      Radio frequency identity tags “RFID” for electronic witnessing of IVF laboratory procedures.
      ,
      • Thornhill A.R.
      • Brunetti X.O.
      • Bird S.
      • Bennett K.
      • Rios L.M.
      • Taylor J.
      Reducing human error in IVF with electronic witnessing.
      ). The latter system has two major advantages: it prevents embryologists working contemporaneously on more than one sample at a time, and it records and controls each step of the procedure, preventing operators from omitting key tasks in the witnessing process. The use of these electronic systems is rapidly extending to fertility clinics worldwide (
      • Glew A.M.
      • Hoha K.
      • Graves J.
      • Lawrence H.
      • Read S.
      • Ah-Moye M.
      Radio frequency identity tags “RFID” for electronic witnessing of IVF laboratory procedures.
      ,
      • Schnauffer K.
      • Kingsland C.
      • Troup S.
      Barcode labelling in the IVF laboratory.
      ).
      Failure mode and effects analysis (FMEA) is a proactive method aimed at identifying real or potential breakdowns in processes and at developing strategies to mitigate risks. This approach is based on the concept that the importance of each identified potential error is related to the likelihood of occurrence, severity of the consequences and probability of detection. It therefore enables a numerical value, called risk priority number (RPN), to be calculated, which is used to plan changes in practices to mitigate the risk of mistake occurrence.
      In this study, an FMEA analysis was carried out in a busy IVF centre with more than 20 years experience, before and after the introduction of an EWS, to comprehend the possible failure modes associated with traceability. The advantages related to the use of an EWS are also analysed.

      Materials and methods

      Study design

      This study was conducted at the GENERA Centre for Reproductive Medicine of Clinica Valle Giulia of Rome. This unit is relatively large, carrying out over 1000 IVF cycles a year. The IVF team is composed of eight gynaecologists, nine embryologists, four dedicated nurses and four administrative personnel. The same team also works in three affiliated centres. For the purpose of this study, a multidisciplinary working group guided by external specialists of the Italian National Transplant Centre (CNT, Superior Institute of Health, Rome, Italy) was formed. All members of the team were initially instructed about proactive risk assessment and FMEA methodology. The traceability system developed by the team on the basis of their experience, and used in four different IVF centres for more than 10 years, was reviewed. The analysis did not include the pre-implantation genetic diagnosis (PGD) programme. A second analysis was carried after the implementation of an EWS (IVF Witness, RI, UK). The EWS was monitored for 6 months after its introduction. Institutional Ethics Committee approval was obtained on 9 June 2014.

      IVF team and FMEA analysis

      The IVF team consisted of seven members, including the Quality Management and Quality Assurance Manager for the centre, a gynaecologist, the Laboratory Director, an embryologist, a nurse, the external risk management specialist and an expert in human factor. Administrative personnel were involved only when specific processes where analysed.
      The FMEA analysis consisted of first mapping the whole traceability process from gamete procurement to final disposition. Each step was described, responsibilities identified and a flow diagram produced (Figure 1). Any possible source of error (real or potential) was discussed. The analysis focused on elucidating the reasons why failure might occur, and estimating likelihood of incidence, severity of the consequences and chance of detection. A score was then calculated for each phase of the process to prioritize and quantify the potential risks of failures (RPN). A value in the range 1–5 was attributed for the probability of occurrence (O), severity of its impact on the process (S) and chance of detection (D) according to the Joint Commission International (
      • Joint Commission on Accreditation of Healthcare Organizations
      An introduction to FMEA. Using failure mode and effects analysis to meet JCAHO's proactive assessment requirement. Failure mode and effect analysis.
      ;
      • Joint Commission Resources
      • Joint Commission International
      Failure Mode and Effects Analysis in Health Care: Proactive Risk Reduction.
      ) with the subsequent described classification.
      Figure thumbnail rbmo1394-fig-0001
      Figure 1The traceability and witnessing protocol in use before the introduction of the electronic witnessing system.
      Occurrence was scored as follows: remote occurrence (score 1), failure unlikely to occur, in ≈1/10,000 IVF cycles; low occurrence (score 2), relatively rare, in ≈1/1000 IVF cycles; moderate occurrence (score 3), occasional, in ≈1/200 IVF cycles; high occurrence (score 4), recurrent, in ≈1/100 IVF cycles and very high occurrence (score 5), common failure, in ≈1/20 IVF cycles. The relational database recording cycles data of the IVF unit was retrospectively analysed to calculate the occurrence of specific process failures.
      Severity was scored as follows: no injury for gametes, embryos or patients (score 1); temporary injury needing additional intervention (double check; delay in the procedure) (score 2); temporary injury with potential reduction in the efficacy of the treatment (partial loss of material) (score 3); permanent effect on gametes and embryos (complete loss of material) (score 4); permanent effect on patients (gametes or embryos mismatch) (score 5).
      Detection was scored as follows: very high: probability of detection 100% (score 1), high: probability of detection ≈70% (score 2); medium: probability of detection ≈40% (score 3), low: probability of detection ≈10% (score 4); remote: probability of detection ≈1% (score 5). The RPN was then obtained by multiplying these three factors (O × S × D).
      An RPN between 1 and 15 was considered a low risk of failure, between 15 and 50 a moderate risk and over 50 a high risk of failure. Each score was evaluated and agreed by the entire team according to the previously described criteria and after a comprehensive collective discussion.

      Electronic witness system

      IVF Witness is an EWS (Research Instruments, UK) based on RFID cards and tags able to track and record a patient's unique identifier and corresponding samples at each step of the IVF process. First, an individual identity card is created for each patient in the presence of a human witness who verifies the accuracy of the reported information. This card is then given to the patient who produces the identity card at the point of donation (egg retrieval and sperm collection) and reception (embryo transfer). The card automatically connects with the IVF laboratory to safeguard the matching of the patient's identity with first identification of the cells. Each container is allocated a RFID tag. These include dishes or tubes that contain gametes or embryo samples, and are automatically assigned to the patient once positioned in the working area of the laminar flow. These tags are able to monitor simultaneously all the procedures carried out in the laboratory, capturing information on cycle progress and operator actions, i.e. transfer of gametes or embryos from one container to the next. The information is immediately visible on a screen located next to each working area. All recorded data are also sent to a server and can be added to the patient's records. If samples from incompatible patients are introduced into the same working area, the system warns the laboratory personnel with both visual and audio alerts before a mismatch can occur. For cryopreservation, specific barcode labels are used for straw identification. The system is only able to identify containers and not individual embryos. Procedural errors derived from the simultaneous presence of two different patient samples in the working area are defined as ‘primary errors’, whereas errors derived from common mistakes, i.e. pre-allocated tags within the frequency range of the reader, but outside the work area, are defined as ‘secondary errors’.
      After implementation of the EWS, the team evaluated its efficacy in reducing the risk of occurrence and increasing the detectability of the identified failures modes. The new system was then monitored for 6 months.

      Results

      The IVF team identified seven main process phases: oocyte collection, sperm donation, gamete processing, insemination, embryo culture, embryo transfer and cryopreservation. A total of 19 associated process steps were documented: identification of the patient in the operating theatre, labelling and assignation of oocyte tubes and dishes, positioning and incubation of oocytes, final check by the second operator, recording of critical data on the patient file for oocyte collection; male partner identification, labelling and assignation of the sperm pot, recording of critical data on the patient file for sperm donation; oocytes and sperm identification at insemination; culture dish identification; embryo change over during culture; patients identification at embryo transfer, preparation of the embryo transfer dish; recording of critical data on the patient's file for embryo transfer; embryo incubation with cryoprotectants at cryopreservation, straws identification, storage positioning, recording of critical data on the patients file for cryopreservation, identification of the straws at thawing.
      All phases were potentially exposed to mistakes in the traceability system (Table 1), 32 failure modes were identified. The highest RPN was 30, confirming the relative moderate risk that mismatches may occur in IVF when a witnessing system based on double-checking approach and permanent recording of critical data is used. The most vulnerable steps were related to first identification at gamete collection or at gamete or embryo thawing (Table 2). The IVF team recognized that the possible causes of failures were mainly associated with heavy clinical workload and distraction, communication failures between the team and inadequacy of the labelling system used.
      Table 1Process phases, number of process steps, number of failure modes and relative risk priority numbers before and after implementating the electronic witnessing system.
      Process phasesProcess steps

      n (%)
      Failure modes

      n (%)
      High/moderate risk modes without EWS (RPN >15)Highest RPN without EWSHigh/moderate risk modes with EWS (RPN >15)Highest RPN with EWS
      1. oocyte retrieval4 (21.1)8 (25.0)230010
      2. sperm collection2 (10.5)5 (15.6)230010
      3. gamete processing2 (10.5)4 (12.5)01004
      4. insemination3 (15.8)3 (9.4)01004
      5. embryo culture1 (0.5)2 (6.3)01004
      6. embryo transfer3 (15.8)4 (12.5)130010
      7. cryopreservation4 (21.1)6 (18.8)130010
      EWS = electronic RPN = relative risk priority.
      Table 2Failure mode and effects analysis of most relevant risk modes identified before and after the implementation of the electronic witnessing system.
      Most relevant risk modesProcess phaseBefore EWS implementationAfter EWS implementation
      OSDRPNFailure modes and possible consequencesCause of failureOSDRPNCorrective measure
      1. Operating theatre list not respectedoocyte retrieval35230Failure in patient identification, oocyte mismatchTeam communication failure25110Patient ID card
      2. Incorrect tube/dish labellingoocyte retrieval34224Failure in cell identification, partial or total loss of oocytesInappropriate labelling system1414Electronic tag
      3. Contemporaneous sample collectionssperm collection35230Failure in patient identification, sperm mismatchHeavy workload and distraction25110Patient ID card
      4. Incorrect pot labellingsperm collection34224Failure in cell identification, partial or total loss of spermInappropriate labelling system1414Electronic tag
      5. Operating theatre list not respectedembryo transfer35230Failure in patient identification, embryo mismatchTeam communication failure25110Patient ID card
      6. Contemporaneous thawing of different samplescryopreservation35230Failure in straw identification, gamete/embryo mismatchHeavy workload and distraction25110Electronic tag and Barcode
      D = detection; EWS = electronic witnessing system; O = occurrence; RPN = risk priority number; S = severity.
      After the implementation of the EWS, none of the vulnerable steps in the revised traceability system had an RPN greater than 10 (Table 2). The reduction in the RPN scores for the higher failure modes was two-thirds (from 30 to 10) (Figure 2). Re-evaluations conducted by the Laboratory Director 1 and 6 months after completing the implementation of the EWS confirmed that the technological innovation introduced was successful in reducing potential risks. A better monitoring of the traceability system was also possible with all steps and mistakes in the witnessing process being recorded by IVF Witness software (Table 3). In the first month (validation period) 1993 witnessing steps were carried out involving 297 patients. In this period, a double manual witness was simultaneously carried out. A total of 16 errors (0.8%) were identified and recorded, two of which were considered as primary human errors (0.1%) requiring additional intervention. The system was always capable of alerting personnel before a possible mismatch occurred. After the validation period (5 months), 8628 witnessing steps involving 1217 patients were carried out. The total error rate recorded was 0.13% (11/8628); excluding the secondary errors, a primary human error rate was documented, potentially leading to mismatch of 0.05% (4/8628) (Table 3). All errors were correctly intercepted by the IVF witness system. Errors caused by system configuration were 0.01% (1/8628).
      Figure thumbnail rbmo1394-fig-0002
      Figure 2Severity, occurrence and detectability (range 1–5) of the most significant risk modes before (A) and after (B) the implementation of an electronic witnessing system. Risk mode 1 = operating theatre list not respected at oocyte retrieval; risk mode 2 = incorrect tubes/dishes labelling; risk mode 3 = contemporaneous sperm samples collections; risk mode 4 = incorrect sperm pot labelling; risk mode 5 = operating theatre list not respected at embryo transfer; risk mode 6 = contemporaneous thawing of different samples.
      Table 3Witness Statistic Report after the implementation of the electronic system (IVF Witness, RI, UK). Primary errors include procedural errors derived from the simultaneous presence of two different patient samples in the working area; secondary errors include procedural mistakes not involving directly biological samples.
      MeasurementValidation period value (1 month)Monitoring period value (5 months)
      Number of witness points19938628
      Number of patients treated2971217
      Number of cycles conducted (fresh plus frozen)2101010
      Number of errors (% per witness points)16 (0.80)11 (0.13)
      Number of patient involved in procedural errors (% per patients treated)22 (7.41)14 (1.15)
      Number of primary errors (% per witness points)2 (0.10)4 (0.05)
      Number of secondary errors (% per witness points)14 (0.70)7 (0.08)

      Discussion

      In this study, an FMEA analysis was carried out in a large IVF centre with the aim of identifying the potential failures associated with the traceability process (with the exclusion of PGD procedures). An RPN scoring system based on occurrence, severity and detectability was used to identify the elements that most likely contribute to serious failures in the process. The results of the analysis have shown that patient identification at donation–transfer and gamete–embryo identification during cryopreservation represented the most vulnerable process phases and therefore the main target for improvement. Although the risk was estimated to be relatively low (maximum RPN = 30), the FMEA analysis determined that a strict traceability system based on double-checking by a second operator and permanent recording of critical data is nevertheless potentially subject to mistakes. In our institution, the identified causes of mistakes were mainly related to heavy workload and distraction, a breakdown in team communication and inadequate hand-written labels.
      Heavy workload, insufficient personnel, i.e. during weekends, and distraction, i.e. telephone ringing, are the main causes of errors in the laboratory, mainly leading to potential mistakes or omissions in the witnessing process. In particular, contemporaneous witnessing may not be possible during sensitive phases, i.e. high number of straws from different patients to be thawed on the same day when personnel are busy, making the entire procedure vulnerable. Automaticity in witnessing has also been suggested as a potential source of error by our team. These situations are not generally registered but well known and relatively common (
      • de los Santos M.J.
      • Ruiz A.
      Protocols for tracking and witnessing samples and patients in assisted reproductive technology.
      ). The main consequences of failures in the correct witnessing process are the partial or total loss of biological material. It was concluded by our team that the witnessing procedure based on the second operator is unavoidably a potential source of human error, especially when hundreds of procedures are conducted each day.
      Team communication is a fundamental issue especially when the order of the programmed procedures is not respected. In the case of egg retrieval, for example, the female partner was identified in an adjacent room (pre-anaesthesia room) before entry into the operating theatre by at least two members of the team, i.e. the embryologist and the nurse (witness). A retrospective analysis of our database showed that, in one out of 250 cycles, a clinician asked to force the order of the operating list (occurrence score 3, occasional). The nurse was clearly informed, prepared the patient indicated by the clinician, and a new patient identification was correctly performed by the clinician and the nurse (witness). A failure to communicate the change to the embryological team may result in mis-assignment of the retrieved oocytes in the laboratory (tubes and dishes being pre-labelled for the previous identified patient). The mistake is then often picked up by the clinician, and the embryologist at the planned final check on completion of the procedure (Figure 1) (detection score 2, high). Only a second consecutive mistake and lack of a final check would result in a potential successive real mismatch (severity score 5, permanent effect). The error could also be identified, however, when the following patient is treated and a second identification is carried out. This series of mistakes, however, potentially results in a loss of biological material (mis-assigned tubes do not comply with clinical use). This example also highlights the ambiguity in task assignment of our protocol, which requires different professionals to identify patients in the operating theatre (nurse, clinician, embryologist) without clearly indicating the contemporaneity of the process.
      Hand-written labelling was also identified as a potential source of error. Although name and identifier were marked on all the tubes and dishes, illegibility or imperfect spelling may have resulted in partial or total loss of biological material.
      Contrary to expectation, the moment of insemination (requiring the matching between female and male partner's gametes) was not considered a vulnerable phase (RPN = 10), probably owing to the strong awareness of the team of the importance of this well-controlled laboratory phase.
      Although no real mismatches were ever reported in our centre, and its occurrence was recognized as improbable (requiring two mistakes to occur consecutively), we decided to further increase the safety of our busy programme in Rome by the introduction of an EWS. A second FMEA analysis showed that the potential risk of failures of all the identified vulnerable phases of the process documented by the team were in fact mitigated. An electronic card that automatically communicates with the laboratory is now used for patient identification; witnessing now relies on an automatic system and needs fewer personnel; all labelling is carried out with radio-frequency tags; and treatment information, including actions of operators and timings, are automatically recorded. Although the severity of the consequences cannot be reduced, occurrence, and in particular, detection of failure modes, can be significantly improved by the presence of the EWS.
      Our analysis did not include PGD procedures that have a different degree of complexity and require, in our opinion, a dedicated individual FMEA. For PGD, the patient's identity and related gametes and embryos have to be traced; additionally, each single embryo within the cohort has to be identified. Moreover, traceability also has to be guaranteed outside the IVF laboratory during transportation and genetic processing. It has to be underlined that, currently, our EWS cannot individualize single embryos; therefore, single embryo traceability for PGD relies only on human double witnessing.
      In our experience, FMEA is an effective tool that fosters a team effort in generating a comprehensive overview of the different phases of the IVF process, together with a careful assessment and grading of potential associated risks. The proactive approach can help to prevent adverse events before they happen and promote corrective actions. Moreover, it is a team building experience reinforcing knowledge and consciousness on routine procedures.
      We recognize, however, the limitation of the present study, which was conducted in a single setting, with personalized protocols for traceability and witnessing. The specific results are therefore only applicable to our group. Moreover, FMEA has been shown to be a useful prospective tool, although its absolute validity is questionable owing to the subjectivity of the judgments (
      • Shebl N.A.
      • Franklin B.D.
      • Barber N.
      Failure mode and effects analysis outputs: are they valid?.
      ).
      In conclusion, FMEA is effective in supporting expert multidisciplinary IVF groups in further understanding traceability and witnessing processes, and identifying their own critical steps in which failures may occur. Because of the irreversible and dramatic consequences of mismatches in IVF, it is suggested that proactive risk-assessment analysis is used to to enhance safety and that implementation of EWS is considered to prevent potential risks, as shown in our institution.

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      Biography

      Laura Rienzi has 20 years experience in the field of embryology. She has academic degrees in biology and reproductive medicine. She has an intese scientific activity including educational, editorial and author of almost 100 articles, reviews and book chapters. In 2008, together with Dr Filippo Maria Ubaldi, she established the GENERA Centres. Current areas of interest include IVF, ICSI, human embryo culture, studies of gamete, zygote and embryo morphology in relation to their developmental ability and chromosomal constitution, as well as cryopreservation. Laura has held a key role in the clinical application of oocyte vitrification in Italy.