1 |
Van Tilburg et al., 2006(1616 Van Tilburg CM, Leistikow IP, Rademaker CMA, Bierings MB, Dijk ATHV. Health care failure mode and effect analysis: a useful proactive risk analysis in a pediatric oncology ward. Qual Saf Health Care. 2006;15(1):58-63. https://doi.org/10.1136/qshc.2005.014902 https://doi.org/10.1136/qshc.2005.014902...
)
|
Netherlands |
Pediatric Oncology Unit |
FMEA DeRosier et al., 2002(3131 Agência Nacional de Vigilância Sanitária - ANVISA. Gestão de riscos e investigação de eventos adversos relacionados à assistência à Saúde. Série Segurança do paciente e qualidade em serviços de saúde [Internet]. Brasília: ANVISA , 2017 [cited 2018 Jul 02]. 92p. Available from: https://www20.anvisa.gov.br/segurancadopaciente/index.php/publicacoes/item/caderno-7-gestao-de-riscos-e-investigacao-de-eventos-adversos-relacionados-a-assistencia-a-saude https://www20.anvisa.gov.br/segurancadop...
)
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Investigate whether HFMEA is valid for analyzing health care processes, such as chemotherapy administration in a pediatric oncological hospitalization environment. |
1Team assembly; 2. Flow diagram; 3. Risk analysis; 4. Actions of the process results. |
1. Changes in treatment schedules; 2. Chemotherapy schedules; 3. Determine the minimum number of residents; 4. Prescription of chemotherapy requests by residents. |
1. Professionals' satisfaction about utility, expectations, time planning, participation of parents/patients. |
2 |
Martin et al., 2017(1717 Martin LD, Verma EBGS, Latham GJ, Rampersad SE, Martin LD. Outcomes of a Failure Mode and Effects Analysis for medication errors in pediatric anesthesia. Paediatr Anaesth. 2017;27(6):571-80. https://doi.org/10.1111/pan.13136 https://doi.org/10.1111/pan.13136...
)
|
USA |
Children's academic hospital |
FMEA Chang et al., 2012(3232 Yamamoto MS, Peterlink MAS, Bohomol E. Spontaneous reporting of medication errors in pediatric university hospital. Acta Paul Enferm. 2011;24(6):766-71. https://doi.org/10.1590/S0103-21002011000600006 https://doi.org/10.1590/S0103-2100201100...
)
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Analyze FMEA in the practice of medication performed in the operating room of a children's hospital, assessing each stage of the treatment process, scoring possible failures and risks. |
1. Team set-up; 2. Flow definition; 3. Determination of "failure modes"; 4. Risk priority number (RPN) of failures 5. Interventions for those with the highest RPN. |
1. Reorganization of the medication tray; 2. Top model of medication cart; 3. Syringe labelling; 4. Double infusion check; 5. Medication practice guideline. |
Use of charts with failure scores and effects before and after the applied interventions. |
3 |
Daverio et al., 2015(1818 Daverio M, Fino G, Luca B, Zaggia C, Pettenazzo A, Parpaiola A, et al. Failure mode and effective analysis ameliorate awareness of medical errors: a 4-year prospective observational study in critically ill children. Paediatr Anaesth. 2015;25(12):1224-7. https://doi.org/10.1111/pan.12772 https://doi.org/10.1111/pan.12772...
)
|
Italy |
PICU |
FMEA Reference not mentioned |
Describe the tendency of CI in PICU over a period of 4 years and assess the effect of FMEA application on the tendency and severity of medical errors. |
1. Process selection; 2. Team selection; 3. Design of the process 4. Failure and effect identification; 5. Numeric value to identify weaknesses; 6. Improvement strategies. |
Not performed. |
1. 165% increase in report production; 2. Decrease in the severity of errors. |
4 |
Rodríguez et al., 2014(1919 Rodríguez SM, Galindo ACS, Herce JL, Hernández MAC, Peinado II, Álvarez AC, et al. Risks in the implementation and use of smart pumps in a pediatric intensive care unit: application of the failure mode and effects analysis. Int J Technol Assess Health Care. 2014;30(2):210-7. https://doi.org/10.1017/S0266462314000051 https://doi.org/10.1017/S026646231400005...
)
|
Spain |
PICU |
FMEA Joint Commission on Accreditation of Healthcare Organizations(3333 World Health Organization (WHO). Conceptual framework for the international classification for patient safety [Internet]. Geneva; 2009 [cited 2018 Jul 01]. Available from: https://www.who.int/patientsafety/taxonomy/icps_full_report.pdf https://www.who.int/patientsafety/taxono...
)
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Carry out FMEA on the risks in the use of intelligent infusion pumps in PICU before and after the implementation of the devices to identify improvement actions. |
1. Team assembling; 2. Identify risks at different stages; 3. Qualitative analysis of failure cause and effect; 4. Quantitative analysis for each error; 5. Actions to minimize the probability of occurrence. |
Conducting periodic reviews of the medicines library, developing supporting documents and including training. After 18 months, smart pump technology was introduced into PICU. |
Use of the GuardrailsR CQI v4.1 Event Reporter Software |
5 |
Lago et al., 2012(2020 Lago P, Bizzarri G, Scalzotto F, Parpaiola A, Amigoni A, Putoto G, et al. Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report. BMJ Open. 2012;2(6):1-9. https://doi.org/10.1136/bmjopen-2012-001249 https://doi.org/10.1136/bmjopen-2012-001...
)
|
Italy |
Pediatric hospital |
FMEA Reference is not mentioned. |
Examine the dangers associated with the drug delivery process to children by conducting a proactive risk assessment analysis. |
1. Team set-up; 2. Flow diagrams; 3. Highlight possible sources of errors; 4. Reason for failure; 5. Quantify the severity of the effects; 6. Risk reduction strategy. |
1. Preprint label for patient identification; new way of reordering medicines; quiet place to prepare recipes; active ingredient prescription; prescription with understandable writing; 2. Clinical audits. |
RPN values before and after interventions. |
6 |
Berruyer et al., 2016(2121 Berruyer M, Atkinsona S, Lebela D, Bussie`res JF. Failure mode and effects analysis (FMEA) of insulin in a mother-child university-affiliated health center. Arch Pediatr. 2016;21(1):1-8. https://doi.org/10.1016/j.arcped.2015.09.033 https://doi.org/10.1016/j.arcped.2015.09...
)
|
Canada |
Installation of parents and children of the University Hospital of Montreal |
FMEA Institute of Safe Medication Practices(3434 Predebon CM, Silva SC, Olaves FS, Kantorski KJC, Pedro ENR, Wegner W. Perfil das notificações de incidentes analisados pela comissão de qualidade e segurança pediátrica. In: ANAIS - I Congresso Internacional da Rebraensp [Internet]. 2016 [cited 2019 Nov 04]. Available from: https://www.lume.ufrgs.br/bitstream/handle/10183/140646/000991213. pdf?sequence=1 https://www.lume.ufrgs.br/bitstream/hand...
)
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Assess the risks associated with insulin use in a health unit and propose an action plan to reduce the main risks associated with failures. |
1. Classification of the failure mode grid by a team; 2. Calculation of criticality indexes; 3. Approval of classifications; 4. Data analysis. |
1. Audit; 2. Update service appropriations with insulin; 3. Reassessment of dispensation policy; 5. Raise caregivers' awareness. |
Assessment of criticality indexes. |
7 |
Dehnavieh et al., 2015(2222 Dehnavieh R, Ebrahimipour H, Taleghani YM, Najar AV, Hekmat SN, Esmailzdeh H. Proactive Risk Assessment of Blood Transfusion Process, in Pediatric Emergency, Using the Health Care Failure Mode and Effects Analysis (HFMEA). Glob J Health Sci. 2015;7(1):322-31. https://doi.org/10.5539/gjhs.v7n1p322 https://doi.org/10.5539/gjhs.v7n1p322...
)
|
Iran |
Pediatric Emergency Department |
FMEA (HFMEA) Cheng et al, 2012(3535 Najar AV, Ghane H, Ebrahimipour H, Nouri GA, Dadpour B. Identification of priorities for medication safety in the neonatal intensive care unit via failure mode and effect analysis. Iranian J Neonatol[Internet]. 2016 [cited 2020 Aug 12];7(2):28-34. Available from: http://ijn.mums.ac.ir/article_7113.html http://ijn.mums.ac.ir/article_7113.html...
)
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Assess the risk in the blood transfusion process in a pediatric emergency through the FMEA tool. |
1. Team meeting; 2. Flow diagram 3. Harm analysis in 04 phases; 4. Measure of action; 4.1. Action description; 4.2. Process redesign. |
Not performed. |
Not mentioned. |
8 |
Apkon et al., 2004(2323 Apkon M, Leonard J, Probst L, DeLizi L, Vitale R. Design of a safer approach to intravenous drug infusions: failure mode effects analysis. Qual Saf Health Care. 2004;13(4):265-71. https://doi.org/10.1136/qshc.2003.007443 https://doi.org/10.1136/qshc.2003.007443...
)
|
USA |
PICU |
FMEA Grissinger et al., 2002(3636 DeRosier J, Stalhandske E, Bagian JP, Tina NMS. Using health care failure mode and effect analysis: the VA National Center for Patient Safety’s prospective risk analysis system. J Comm Qual Improv. 2002;28(5):248-67. https://doi.org/10.1016/S1070-3241(02)28025-6 https://doi.org/10.1016/S1070-3241(02)28...
) (Joint Commission on Accreditation of Healthcare Organizations) |
Administer continuous infusions, improving patient safety, team, hemodynamic stability during infusion and efficient use of resources. |
1. Characterize process steps; 2. Identify failure modes; 3. RPN calculation; 5. Corrective measures for elements with the highest RPN. |
1. Standard formulations; 2. Calculators for multiple computing platforms; 4. Prefabricated purchase and stock; 5. Change the responsibility for the pharmacy preparation. |
1. Team satisfaction; 2. RPN assessment, severity (S), occurrence (O) and detection (D) values before and after corrective measures. |
9 |
Robinson et al., 2006(2424 Robinson DL, Heigham M, Clark J. Using Failure Mode and Effects Analysis for safe administration of chemotherapy to hospitalized children with cancer. J Comm J Qual Patient Saf. 2006;32(3):161-6. https://doi.org/10.1016/s1553-7250(06)32021-1 https://doi.org/10.1016/s1553-7250(06)32...
)
|
USA |
Pediatric Oncology Unit |
FMEA (HFMEA) Adachi W, Lodolce A, 2005(3737 Joint Commission Resources. Joint Commission International. Root Cause Analysis in Health Care: Tools and Techniques. 5. ed. Oak Brook: The Joint Commission; 2015.)
|
Use FMEA to identify appropriate risks and strategies in the administration of chemotherapy in children. |
1. Data collection; 3. Flowchart; 4. Failure points and the cause. 5. Identify the cause; 6. Strategies to reduce risks. |
The team made and implemented the recommendations in the process of medication prescription and administration. |
Comparison of the percentages of prescription error, medication dispensing and administration. |
10 |
Babiker et al., 2017(2525 Babiker A, Amer YS, Osman ME, Al-Eyadhy A, Fatani S, Mohamed S, et al. Failure Mode and Effect Analysis (FMEA) may enhance implementation of clinical practice guidelines: an experience from the Middle East. J Eval Clin Pract. 2018;24(1):206-11. https://doi.org/10.1111/jep.12873 https://doi.org/10.1111/jep.12873...
)
|
Saudi Arabia |
Department of Pediatrics, King Khalid University Hospital |
FMEA IHI Workspace online(3838 Ceccim RB. Permanent health education: decentralization and dissemination of pedagogical capacity in health. Ciênc Saúde Colet. 2005;10(4):975-86. https://doi.org/10.1590/S1413-81232005000400020 https://doi.org/10.1590/S1413-8123200500...
)
|
Provide an accurate assessment of the occurrence and frequency of failures and their effects on clinical practice. |
1. Team assembling; 2. Training on FMEA; 3. Data collection; 4. Identification of potential failures; 5. Score for each attribute item; 6. The number of risk priorities was calculated. |
1. Regular audit; 2. Improvement of Clinical Practice Guidelines (CPG); 3. Quality improvement; 4. Organization of awareness-raising activities; 5. Availability of printed or electronic materials; |
1. Number of adapted CPGs finalized; 2. Number of general awareness-raising sessions; 3. Number of educational sessions; 4. Percentage of patients who achieved the results. |
11 |
Jayashree et al., 2017(2626 Jayashre M, Sasidharan R, Singhi S, Nallasamy K, Baalaaji M. Root cause analysis of diabetic ketoacidosis admissions at a tertiary referral pediatric emergency department in North India. Indian J Endocrinol Metab. 2017;21(5):710-4. https://doi.org/10.4103/ijem.IJEM_178_17 https://doi.org/10.4103/ijem.IJEM_178_17...
)
|
India |
Emergency department |
RCA Iedema et al., 2006(3939 Hamilton MJ, MCEniery JA, Osborne JM, Coulthard MG. Implementation and strength of root cause analysis recommendations following serious adverse events involving paediatric patients in the Queensland public health system between 2012 and 2014. J Paediatr Child Health. 2019;55(9):1070-6. https://doi.org/10.1111/jpc.14344 https://doi.org/10.1111/jpc.14344...
)
|
Identify factors contributing to admissions to the Emergency Department (ED) of children with diabetic ketoacidosis, with emphasis on awareness of parents, the doctor and prenatal management. |
1. Theme discussion; 2. Questionnaire formulation; 3. Preparation of a causal factor diagram; 4. Identification of complications, their causes and effects; 5. Use of descriptive statistics of the data found. |
Not performed. |
Not mentioned. |
12 |
Bonnabry et al., 2005(2727 Bonnabry P, Cingria L, Sadeghipour F, Ing H, Christ CF, Pfister RE. Use of a systematic risk analysis method to improve safety in the production of pediatric parenteral nutrition solutions. Qual Saf Health Care. 2005;14(2):93-8. https://doi.org/10.1136/qshc.2003.007914 https://doi.org/10.1136/qshc.2003.007914...
)
|
Switzerland |
Pediatric hospital |
FMEA McDonough, 2003(4040 Ricaldoni CAC, Sena RR. Permanent education: a tool to think and act in nursing work. Rev Latino Am Enferm. 2006;14(6):837-42. https://doi.org/10.1590/S0104-11692006000600002 https://doi.org/10.1590/S0104-1169200600...
)
|
Compare the risks associated with old and new processes to quantify improved safety with the new process and identify risks to improve safety in the production of pediatric parenteral nutrition solutions. |
1. Team assembling; 2. Definition of process stages; 3. Brainstorming; 4. Cause-effect diagram; 5. Comparison of the two methods |
Implementation of integrated access software, in order to guide the prescribing physician and connect the prescription process directly to the production process, including pharmaceutical validation, labeling and composition. |
The sum of CIs from all 18 identified failure modes was 3,415 for the old process and 1,397 for the new one (59% reduction). |
13 |
Morse et al., 2011(2828 Morse RB, Pollack MM. Root cause analyses performed in a children's hospital: events, action plan strength, and implementation rates. J Healthc Qual. 2012;34(1):55-61. https://doi.org/10.1111/j.1945-1474.2011.00140.x https://doi.org/10.1111/j.1945-1474.2011...
)
|
USA |
Pediatric hospital |
RCA The Joint Commission, 2009(41)
|
Establish a reference point to monitor the strength of action plans developed through RCA and its execution rates. |
1. Each RCA was analyzed by the Director of the Quality Department; 2. Actions developed to address each individual event were classified as weak, intermediate or strong, using the recommended hierarchy of actions. |
1. Improvement in documentation and communication; 2. Software improvement in the entry of computerized requests; 3. Reduce distractions; 4. Standardize processes; 5. Continued training; 6. Analyze and inspect equipment. |
Comparison of the implementation of the actions developed as a result of RCAs with previous studies. |
14 |
Tjiaet al., 2014(2929 Tjia I, Rampersad S, Varughese A, Heitmiller E, Tyler DC, Lee AC, et al. Wake Up Safe and root cause analysis: quality improvement in pediatric anesthesia. Anesth Analg. 2014;119(1):122-36. https://doi.org/10.1213/ANE.0000000000000266 https://doi.org/10.1213/ANE.000000000000...
)
|
USA |
Pediatric hospital |
FMEA Reference is not mentioned. |
Implement changes in care processes that improve the quality and safety of anesthetic care provided to pediatric patients throughout the country. |
1. Questions to analyze and identify system failures; 2. Team members; 3. Recommendations; 4. Action plan follow up. |
Not performed. |
Not mentioned. |
15 |
Bhalla et al., 2012(3030 Bhalla T, Dairo OO, Martin D, Wrona S, Fetzer M, Taghon T, et al. A proactive risk assessment by utilizing ‘Healthcare Failure Mode and Effect Analysis’ (HFMEA) for safe implementation of peripheral nerve catheters in pediatric patients. APIC. 2014;18(1):21-4. https://doi.org/10.1016/j.jpain.2012.01.282 https://doi.org/10.1016/j.jpain.2012.01....
)
|
USA |
Department of Anesthesiology of Nationwide Children's Hospital |
FMEA (HFMEA) Reference is not mentioned |
Identify failure modes and their causes and effects on the use of peripheral catheters. |
1. Multidisciplinary team assembling; 2. Follow-up meetings and interrogations; 3. Describe the process using process flow maps; 4. Identify potential failure modes related to each step of the process. |
1. Home-going instructions; 2. Design of new labels for pain pump and piping; 3. Design of an electronic order-set; 4. Changes to pharmacy code kits, as well as the modification of hand-offs between services. |
Not mentioned. |