HEALTHCARE FAILURE MODE AND EFFECT ANALYSIS DESIGN FOR INDONESIA HOSPITAL LABORATORIES: A LITERATURE REVIEW
Downloads
Background:Error rate in medical laboratories is very low. Only one error is identified every 330–1,000 events. The goal of laboratory services should outweigh patient safety in a well-structured manner. Healthcare Failure Mode and Effect Analysis (HFMEA) is a proactive preventive method for identifying and evaluating potential failure.
Aims: This study identified factors affecting patient safety in hospital laboratories and described potential risk identification process using the HFMEA.
Methods: This study was conducted between March-July 2020 and retrieved data from PubMed, Scopus, and Google Scholar. The data were generalized and extracted into Table 2 based on factors dealing with patient safety in hospital laboratories. This study performed a risk identification design based on the steps of HFMEA.
Results: Out of 4,062 articles collected, only 8 articles between 2013–2020 were included for analysis. The highest error rate in laboratories occurred in the pre-analytic phase (49.2%–84.5%). The errors included clotted and inadequate specimen volume, and thus the specimens were rejected. Factors related to patient safety in laboratories were patient condition, laboratory staff performance (including training, negligence, and burnout), facilities, and accreditation.
Conclusion: The HFMEA process used the result of hazard analysis with severity and probability criteria categorized into health sector. Decision tree analysis could determine the next step of the work process. The HFMEA must be adjusted to the equipment and technologies in each hospital laboratory. Leader's commitment in monitoring and evaluation is required to maintain patient safety culture. More comprehensive data from Indonesian hospital laboratories are needed to generate more representative and applicable results.
Keywords: error, HFMEA, laboratory, patient safety
Aita, A. et al. (2017) ‘Patient safety and risk management in medical laboratories: theory and practical application', Journal of Laboratory and Precision Medicine, 2(2), pp. 75–75. doi: 10.21037/jlpm.2017.08.14.
Bhat, V. et al. (2012) ‘Analysis of laboratory sample rejections in the pre-analytical stage at an oncology center', Clinica Chimica Acta. doi: 10.1016/j.cca.2012.03.024.
Bonini, P. et al. (2002) ‘Errors in laboratory medicine', Clinical Chemistry. doi: 10.1093/clinchem/48.5.691.
Carraro P, P. M. (2002) ‘Process control reduces the laboratory turnaround time', time. Clin Chem Lab Med, 40, pp. 421–2.
Chadwick, L. and Fallon, E. F. (2012) ‘Evaluation and critique of HFMEA applied in a radiotherapy case study', Human Factors and Ergonomics in MAnufacturing Service Industries, pp. 116–127.
Colman, N. et al. (2019) ‘Prevent Safety Threats in New Construction through Integration of Simulation and FMEA', Pediatric Quality and Safety, 4(4).
DeRosier, J. et al. (2002) ‘Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system.', The Joint Commission journal on quality improvement, 28(5). doi: 10.1016/s1070-3241(02)28025-6.
Guimarí£es, A. C. et al. (2012) ‘Causes of rejection of blood samples handled in the clinical laboratory of a University Hospital in Porto Alegre', Clinical Biochemistry. doi: 10.1016/j.clinbiochem.2011.10.009.
Gunnur Dikmen, Z., Pinar, A. and Akbiyik, F. (2015) ‘Specimen rejection in laboratory medicine: Necessary for patient safety?', Biochemia Medica. doi: 10.11613/BM.2015.037.
Hung, S. H. et al. (2015) ‘Integration of value stream map and healthcare failure mode and effect analysis into Six Sigma methodology to improve process of surgical specimen handling', Journal of Healthcare Engineering. doi: 10.1260/2040-2295.6.3.377.
Jiang, Y. et al. (2014) ‘Application of FMEA in a clinical chemistry laboratory', Clinica Chimica Acta, pp. 80–85.
Kachalia, A. et al. (2007) ‘Missed and Delayed Diagnoses in the Emergency Department: A Study of Closed Malpractice Claims From 4 Liability Insurers', Annals of Emergency Medicine. doi: 10.1016/j.annemergmed.2006.06.035.
Kadić, D., Avdagić-Ismić, A. and Hasić, S. (2019) ‘The prevalence of pre-analytical errors in the laboratory of the Cantonal Hospital Zenica in Bosnia and Herzegovina', Medicinski Glasnik. doi: 10.17392/979-19.
Khairani, G. N. et al. (2015) Manajemen Resiko Prosedur Kerja Pelayanan Laboratorium di Sub Unit Laboratorium Puskesmas Wirobrajan Menggunakan Failure Mood Effect Analysis. Available at: https://docplayer.info/73084492-Manajemen-resiko-prosedur-kerja-pelayanan-laboratorium-di-sub-unit-laboratorium-puskesmas-wirobrajan-menggunakan-failure-mood-effect-analysis.html (Accessed: 3 August 2020).
Kroft, S. H. (2020) ‘Well-Being, Burnout, and the Clinical Laboratory', American Journal of Clinical Pathology. doi: 10.1093/ajcp/aqaa022.
Hospital Report: Failure Mode and Effect Analysis: Identifikasi dan Pengurangan Risiko dalam Pelayanan Laboratorium RS PKU Muhammadiyah Yogyakarta (2015). Yogyakarta. Available at: https://www.scribd.com/document/386009875/Laporan-FMEA-Laboratorium (Accessed: 3 August 2020).
Lichenstein, R. et al. (2016) ‘Laboratory Errors in a Pediatric Emergency Department Network: An Analysis of Incident Reports', Pediatric Emergency Care. doi: 10.1097/PEC.0000000000000414.
Megiwati, L. (2015) Analisis Risiko Keselamatan dan Kesehatan Kerja di Laboratorium Parasitologi FKUI Mengacu pada Standar ISO 31000:2009. Universitas Indonesia.
Patel, S. et al. (2018) ‘Congruity in Quality Indicators and Laboratory Performance', Indian Journal of Clinical Biochemistry. doi: 10.1007/s12291-017-0687-9.
Ministry of Health Republic of Indonesia (2010) Health Regulation Number 411/MENKES/PER/III/2010 Laboratorium Klinik. Indonesia.
Plebani, M. et al. (2006) ‘Laboratory network of excellence: Enhancing patient safety and service effectiveness', Clinical Chemistry and Laboratory Medicine. doi: 10.1515/CCLM.2006.028.
Plebani, M. et al. (2014) ‘Quality indicators to detect pre-analytical errors in laboratory testing', Clinica Chimica Acta. doi: 10.1016/j.cca.2013.07.033.
Romero, A. et al. (2017) ‘Utilization of HFMEA to identify error source in the preanalytical phase in two tertiary hospital laboratories', Biochem Med.
Sakyi, A. et al. (2015) ‘Evaluation of analytical errors in a clinical chemistry laboratory: A 3 year experience', Annals of Medical and Health Sciences Research. doi: 10.4103/2141-9248.149763.
Sciacovelli, L. et al. (2017) ‘Quality Indicators in Laboratory Medicine: The status of the progress of IFCC Working Group "laboratory Errors and Patient Safety” project', Clinical Chemistry and Laboratory Medicine. doi: 10.1515/cclm-2016-0929.
Sinici Lay, I., Pinar, A. and Akbiyik, F. (2014) ‘Classification of reasons for rejection of biological specimens based on pre-preanalytical processes to identify quality indicators at a university hospital clinical laboratory in Turkey', Clinical Biochemistry, 47(12), pp. 1002–1005. doi: 10.1016/j.clinbiochem.2014.04.024.
Sithi, D. N. and Widiastuti, A. (2018) ‘Redesign Ketepatan Identitasi Pasien Dengan Metode FMEA di RSUD Pacitan Jawa Timur', Ciastech 2018, (September), pp. 368–375.
Tack, V. et al. (2018) ‘Accreditation, setting and experience as indicators to assure quality in oncology biomarker testing laboratories', British Journal of Cancer. doi: 10.1038/s41416-018-0204-9.
Vries, M. de et al. (2018) ‘Clinical Observation and a HFMEA to identify vulnerabilities in the security and accounting of medication in Ontario hospital: a study protocol'.
Wahls, T. L. and Cram, P. M. (2007) ‘The frequency of missed test results and associated treatment delays in a highly computerized health system', BMC Family Practice. doi: 10.1186/1471-2296-8-32.
WHO (2019) Patient Safety. Available at: https://www.who.int/news-room/fact-sheets/detail/patient-safety (Accessed: 3 June 2020).
Widianti, T. (2015) ‘Transformasi FMEA menjadi HFMEA: Sebuah Upaya Pengendalian Risiko pada Bidang Kesehatan', Pusat Penelitian Sistem Mutu dan Teknologi Pengujian Lembaga Ilmu Pengetahuan Indonesia, Edisi 1. Available at: http://smtp.lipi.go.id/berita448-Transformasi-FMEA-menjadi-HFMEA-3A-Sebuah-Upaya-Pengendalian-Risiko-pada-Bidang-Kesehatan.html.
1. As an author you (or your employer or institution) may do the following:
- make copies (print or electronic) of the article for your own personal use, including for your own classroom teaching use;
- make copies and distribute such copies (including through e-mail) of the article to research colleagues, for the personal use by such colleagues (but not commercially or systematically, e.g. via an e-mail list or list server);
- present the article at a meeting or conference and to distribute copies of the article to the delegates attending such meeting;
- for your employer, if the article is a ‘work for hire', made within the scope of your employment, your employer may use all or part of the information in the article for other intra-company use (e.g. training);
- retain patent and trademark rights and rights to any process, procedure, or article of manufacture described in the article;
- include the article in full or in part in a thesis or dissertation (provided that this is not to be published commercially);
- use the article or any part thereof in a printed compilation of your works, such as collected writings or lecture notes (subsequent to publication of the article in the journal); and prepare other derivative works, to extend the article into book-length form, or to otherwise re-use portions or excerpts in other works, with full acknowledgement of its original publication in the journal;
- may reproduce or authorize others to reproduce the article, material extracted from the article, or derivative works for the author's personal use or for company use, provided that the source and the copyright notice are indicated.
All copies, print or electronic, or other use of the paper or article must include the appropriate bibliographic citation for the article's publication in the journal.
2. Requests from third parties
Although authors are permitted to re-use all or portions of the article in other works, this does not include granting third-party requests for reprinting, republishing, or other types of re-use.
3. Author Online Use
- Personal Servers. Authors and/or their employers shall have the right to post the accepted version of articles pre-print version of the article, or revised personal version of the final text of the article (to reflect changes made in the peer review and editing process) on their own personal servers or the servers of their institutions or employers without permission from JAKI;
- Classroom or Internal Training Use. An author is expressly permitted to post any portion of the accepted version of his/her own articles on the author's personal web site or the servers of the author's institution or company in connection with the author's teaching, training, or work responsibilities, provided that the appropriate copyright, credit, and reuse notices appear prominently with the posted material. Examples of permitted uses are lecture materials, course packs, e-reserves, conference presentations, or in-house training courses;
