{"id":1115,"date":"2024-07-16T13:16:05","date_gmt":"2024-07-16T04:16:05","guid":{"rendered":"https:\/\/lmi.jp\/articles\/?p=1115"},"modified":"2026-02-16T10:49:03","modified_gmt":"2026-02-16T01:49:03","slug":"the-effect-of-iso-15189-implementation-for-the-reduction-of-incidents","status":"publish","type":"post","link":"https:\/\/lmi.jp\/articles\/2024\/07\/16\/the-effect-of-iso-15189-implementation-for-the-reduction-of-incidents\/","title":{"rendered":"The effect of ISO 15189 implementation for the reduction of incidents"},"content":{"rendered":"\n

Ririka Miura<\/em><\/strong><\/a>*1<\/em><\/sup>, Rikei Kozaka<\/a><\/strong><\/em>*1<\/sup>,\u2020Shinichiro Takahashi,<\/a><\/strong><\/em> MD, PhD*1, 2<\/sup><\/p>\n\n\n\n

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Hirashima T, Aoki E, Kumamoto Y, Suzuki N, Oshima T, Hirano T. The effect of ISO 15189 implementation for the reduction of incidents. Lab Med Int 2024; 3(2): 26-27. doi: 10.51041\/lmi.3.2_26<\/p>\n<\/div><\/details>\n<\/div>\n\n\n\n

Editorial
Lab Med Int 2024; 3(2): 26-27<\/p>\n\n\n\n

\u2020 Correspondence: Division of Laboratory Medicine, Faculty of Medicine, Tohoku Medical and Pharmaceutical University, 1-15-1 Fukumuro, Miyagino-ku, Sendai 983-8536, Japan. E-mail: shintakahashi”@”tohoku-mpu.ac.jp
Received January 10, 2024; accepted March 16, 2024
*1 Department of Clinical Laboratory, Tohoku Medical and Pharmaceutical University Hospital, 1-12-1 Fukumuro, Miyagino-ku, Sendai 983-8512, Japan
*2 Division of Laboratory Medicine, Faculty of Medicine, Tohoku Medical and Pharmaceutical University, 1-15-1 Fukumuro, Miyagino-ku, Sendai 983-8536, Japan<\/strong><\/span><\/p>\n\n\n\n

Download PDF<\/span><\/a><\/div>\n\n\n\n

The way to strengthen medical safety have been attracting attention to deliver definite and accurate clinical laboratory data to physicians1,2)<\/sup><\/strong>. ISO 15189 is an international standard that specifies the quality management system (QMS) requirements particular to medical laboratories, and ISO 15189 has been reported to play an important role in quality improvement and prevention of examination errors3-8)<\/sup><\/strong>.
Recently, we reported about our experience for the effect of ISO 15189 implementation for the reduction of the number of incidents4). We experienced that the total number of incidents decreased significantly even one year after accreditation. In the literature search, similar observations were reported5-8), and in this Editorial, we are going to introduce these papers describing the effect on the reduction of the number of incidents after accreditation of ISO 15189.
First paper is from Yoshiko et al5)<\/sup><\/strong>, from Nagoya University Hospital. They acquired ISO 15189 accreditation in November, 2009. They revealed that post-accreditation, the number of nonconformities and incident reports were decreased. They revealed that the number of incidents were decreased from 100 in 2009, to 94 in 2010. They also revealed that the level 0 and level 1 incidents increased in 2010 (level 0, 13% in 2009 to 18.3% in 2010; level 1, 48% in 2009 to 53.8% in 2010), whereas level 2 and level 3a incidents decreased in 2010 (level 2, 32% in 2009 to 24.7% in 2010; level 3a, 2% in 2009 to 1.1% in 2010), also suggesting that ISO 15189 works well for reduction of number and level of incidents. Additionally, they pointed out some problems related to the post accreditation of ISO 15189, which is the increment of the complaints from the staffs and increase of overtime works to operate QMS5)<\/sup><\/strong>.
Next paper is from Shitara et al6), from Kosei general hospital. They acquired ISO 15189 certification on December 1, 2005. Although they did not investigate the level of the incidents precisely, they revealed the total number of incidents decreased obviously (year, cases; 2003, 57; 2004, 65; 2005, 26; 2006, 25; 2007, 24)6)<\/sup><\/strong>. They also found that, more than 80% of the incidents occurred through 2003 to 2007 were from\u201c5.4 pre-examination processes\u201d, \u201c5.5 examination processes\u201d, and \u201c5.8 reporting of results\u201d in the standard requirements of ISO 15189, and the proportions have not been changed throughout this period6)<\/sup><\/strong>. In addition, the proportions of incidents in each process were relatively similar to those in a previous report9)<\/sup><\/strong>.
Third paper is from Ota et al.7)<\/sup><\/strong>, from St. Mary\u2019s hospital. They acquired ISO 15189 authorization in December 2007. They revealed that total incidents in 2007 was 240 cases whereas 62 cases in 2010, which is three years after accreditation7)<\/sup><\/strong>. What was characteristic in their report was, in the process of authorization acquisition, they tried to improve ward nursing management using ISO 15189, drew up standard operating procedures through detailed job analysis, and enabled ward operation standardization7)<\/sup><\/strong>.
Last paper is from Okada et al.8)<\/sup><\/strong>, from Okayama University hospital. They got ISO 15189 accreditation on July, 2007. In the year of 2005, two years before their accreditation, the total number of incidents was 116. Then the number was decreased to 84, in 2006 and 2007, and finally dropped to 48, a year after accreditation. They concluded that the frequency of laboratory incidents was reduced through seeking the causes of incidents and performing continual improvement according to ISO 15189: \u201cPlan, Do, Check, Act\u201d. They also described that the motivation and competence of laboratory staff concerned have also improved, consequently leading to a favorable influence on other laboratory staff members.
Collectively, all of these published five papers clearly demonstrate that implementation of a QMS meeting ISO 15189 standards is effective for the reduction of incidents. As far as we searched, no paper has been found for the negative effect of ISO 15189 on medical safety. The effect of this implementation may take several years for the sufficient effect for the reduction of incidents. Recently, ISO 15189:2012 has been updated to ISO 15189:2022, with increased emphasis on risk management10)<\/sup><\/strong>. All of reports presented in this paper are based on ISO 15189:2012, or earlier, version of ISO 15189. Therefore, we are now expecting that implementation of this new ISO 15189:2022 QMS will further improve measures for medical safety.<\/p>\n\n\n\n

References<\/h2>\n\n\n\n
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  1. Tsunekawa K, Asai Y, Ikegami S, et al. Incident analysis and preventive measures taken in the general laboratory of hospital. Jap J Med Tech 2019; 68 (2): 333-8.J-STAGE<\/a><\/span><\/li>\n\n\n\n
  2. Maeda F, Izumi S, Nakanishi H, et al. Efforts of inspection technology department and medical safety management committee: lncident accident report, positive report, fiscal year safety target. Jap J Med Tech 2017; 66(4): 404-10.J-STAGE<\/a><\/span><\/li>\n\n\n\n
  3. Kayamori Y, Fujishima A, Noda (Inoue) N, et al. Approach for prevention medical test malpractice using ISO 15189. Rinsho Byori 2010; 58(8): 839-46.PubMed<\/a><\/span><\/li>\n\n\n\n
  4. Miura R, Kozakai R, Suzuki S, et al. Analysis of Incident\/Accident Reports in the Department of Clinical Laboratory at Tohoku Medical and Pharmaceutical University Hospital: Effect of ISO 15189 Implementation on Medical Safety. Lab Med Int 2024; 3(1): 8-14.J-STAGE<\/a><\/span><\/li>\n\n\n\n
  5. Yoshiko K. Effects of the ISO 15189 Accreditation on Nagoya University Hospital. Rinsho Byori 2012; 60(7): 667-73.PubMed<\/a><\/span><\/li>\n\n\n\n
  6. Shitara M, Umezu S, Katsuno H. Effects of the ISO 15189 Accreditation on Clinical Laboratory. Rinsho Byori 2009; 57(6): 521-6.PubMed<\/a><\/span><\/li>\n\n\n\n
  7. Ota Y, Ide H, Tsukamoto T, et al. From the Position of a Private Sector Hospital: ISO 15189 Acquisition by a Clinical Laboratory, and Quality Management System Deployment in the Whole Hospital. Rinsho Byori 2012; 60(7): 677-82.PubMed<\/a><\/span><\/li>\n\n\n\n
  8. Okada K, Itoshima K, Watanabe T, et al. Effect of ISO 15189 accreditation on Okayama University Hospital. Rinsho Byori 2009; 57(10): 971-7.PubMed<\/a><\/span><\/li>\n\n\n\n
  9. Astion ML, Shojania KG, Hamill TR, et al. Classifying laboratory incident reports to identify problems That Jeopardize Patient Safety. Am J Clin Pathol 2003; 120(1): 18-26.PubMed<\/a><\/span><\/li>\n\n\n\n
  10. ISO 15189: 2022. Medical laboratories\u2013requirements for quality and competence. Geneva: International Organization for Standardization; 2022.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

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