project to collect medical near-miss/ adverse event information … · institutions reporting...

Project to Collect Medical Near-miss/Adverse Event Information

2017 Annual Report

October 2, 2018

The current status of the project can be browsed at:Website: http://www.med-safe.jp/English page: http://www.med-safe.jp/contents/english/index.html

Division of Adverse Event Prevention

ISBN978-4-902379-78-5

Project to C

ollect Medical N

ear-miss/A

dverse Event Inform

ation 2016 Annual R

eport


2017 Annual Report

October 2, 2018



ISBN978-4-902379-78-5

Project to C

ollect Medical N

ear-miss/A

dverse Event Inform

ation 2016 Annual R

eport

Project to C

ollect Medical N

ear-miss/A

dverse Event Inform

ation2017 Annual R

eport

Greeting .............................................................................................................................. 1Foreword ............................................................................................................................. 2

I 2017 Annual Report …………………………………………………………………… 3

II Aggregate Reports …………………………………………………………………… 111. Status of Participation in the Project to Collect Medical Near-miss/

Adverse Event Information ………………………………………………………12

2. Project to Collect, Analyze, and Provide Medical Adverse Event Information ………………………………………………………………………………13

[1] Registered Medical Institutions ...........................................................................13[2] Number of Reports ..............................................................................................14[3] Details of Reports Made by Registered Medical Institutions ..............................18

3. Project to Collect, Analyze, and Provide Medical Near-Miss Event Information ………………………………………………………………………………21

[1] Participating Medical Institutions ........................................................................21[2] Information on the Number of Occurrences ........................................................22[3] Number of Medical Near-miss Event Information ...............................................22

III Current Analysis of Medical Near-miss/Adverse Event Information ……………………………………………………………………………… 251. Project Overview ……………………………………………………………………26

[1] Information to be Analyzed ..................................................................................26[2] Analysis System....................................................................................................26[3] Workshop .............................................................................................................27

2. Collection of Follow-Up Information on Medical Adverse Events …28

[1] Collection of Follow-Up Information in Writing ...................................................28[2] Collection of Follow-Up Information via On-site Visits ........................................28

3. Themes Analyzed ……………………………………………………………………37

[1] Selection of Themes for Information to be Analyzed ...........................................37[2] Themes Analyzed in 2017 ....................................................................................37

4. Analysis of Recurrent and Similar Events …………………………………38

[1] Recurrent and Similar Events Highlighted in 2017 ..............................................38

Table of Contents

IV Medical Safety Information …………………………………………………… 391. Summary …………………………………………………………………………………40

[1] Objective ...............................................................................................................40[2] Medical Institutions Receiving Information by Fax .............................................40

2. Content of the Information Provided ………………………………………… 41

V Current Status of the Project ………………………………………………… 43

*This Annual Report has been prepared as part of the Project to Collect Medical Near-miss/Adverse Event Information (project subsidized by the Ministry of Health, Labour and Welfare), based on information about medical adverse events gathered by the project and informed by the opinions of members of the Comprehensive Evaluation Panel, for the purpose of preventing the occurrence and recurrence of medical adverse events. Please refer to the project website for details about the purpose of the project. http://www.med-safe.jp/

*While the JQ takes all possible steps to ensure that the information carried in this report is accurate at the time of compilation, it does not guarantee that the content will remain accurate in the future.

*In preparing this information, the JQ intends neither to restrict the discretion of medical professionals, nor to impose any obligations or responsibilities on them.

- 1 -

Greeting

Hirobumi KawakitaPresident

Japan Council for Quality Health Care

The Japan Council for Quality Health Care runs Hospital Accreditation and a variety of other projects aimed at providing third-party accreditation of medical institutions and supporting the provision of high-quality medical services by medical institutions, in order to improve the quality of medical care and ensure that the public have confidence in it. Today, with health care expected to be more advanced and diverse, we are aware that providing the public with accurate information concerning medical care, and promoting and ensuring high-quality medical care are increasingly important tasks. We believe that the JQ has a major role to play in Japan, given this situation.

In FY2004, the Division of Adverse Event Prevention began implementing the Project to Collect Medical Near-miss/Adverse Event Information, which gathers information about medical adverse events and medical near-miss events, with the objective of promoting safety in medical care. The information gathered concerning medical adverse events is compiled into quarterly reports, in which the total figures for the events and an analysis thereof are also published. These regular quarterly reports and annual reports are made available to a wide range of individuals and organizations in society, including medical professionals, the public, and government bodies. In addition, Medical Safety Information is sent out by fax to medical institutions about once a month. As of December 2017, we have issued 133 Medical Safety Information bulletins. I would like to express my deepest gratitude to the medical institutions and other parties that cooperate with our project by reporting medical near-miss and adverse event information.

We are now publishing the 2017 Annual Report, which is based on the content of previously published quarterly reports. This report carries a large volume of information that can help to promote medical safety, including annual totals for medical near-miss and adverse event information, overviews of on-site visits, overviews of analysis themes and recurrent and similar event analyses, and an overview of workshops held. Accordingly, we hope that this Annual Report will be of use to those working in clinical practice, as well as helping the public to gain a deeper understanding of Japan’s medical safety initiatives as they stand at present.

Having already received considerable feedback, including media coverage and inquiries about medical adverse event figures and the details thereof, we are keenly aware that public concern about the promotion of medical safety and the prevention of medical adverse events is high. We will strive to further enhance the content of our quarterly reports, annual reports, and Medical Safety Information, so that we continue to provide everyone with useful information.

In addition, we at the JQ intend to do our utmost to improve the quality of medical care and ensure that the public has confidence in it through such projects as Hospital Accreditation, thereby raising the standard of Japanese medical care.

We would therefore be most grateful for your continued understanding and cooperation.

- 2 -

Foreword

Shin UshiroDirector


Misa SakaguchiGeneral Manager

Department of Adverse Event PreventionJapan Council for Quality Health Care

We would like to express our deepest gratitude to everyone for your continued understanding and cooperation in regard to the running of this project.

Based on the project plan approved by the JQ Board of Directors meeting held in March 2017, the project has been run during FY2017 with a core focus on the collection, analysis and provision of medical near-miss/adverse event information and training relating to medical safety. As of the end of 2017, 1,473 registered medical institutions were participating in the project and we received 4,095 reports over the course of that year.

We are hereby pleased to publish our 2017 Annual Report, which summarizes the medical near-miss/adverse event information reported between January and December 2017. As well as providing the collated results for the year and an outline of the themes highlighted in the quarterly reports, this Annual Report offers details of on-site visits and events that were recurrences of or similar to events highlighted in Medical Safety Information. We hope that staff at medical institutions, especially those in charge of safety management, will review this report thoroughly and share the parts which are most useful and relevant to the circumstances of their particular medical institution. Moreover, the JQ also hopes that, by reading this Annual Report and viewing information published on the project homepage, the general public, as recipients of medical care, will gain an understanding of the various different types of medical adverse events and medical near-misses and the nature thereof, as well as current efforts by medical institutions and the medical community to prevent their recurrence.

As the project continues to receive around the same number of reports as the previous year, if not more, we believe that the practice of reporting medical adverse events is becoming firmly established. Reports of events that can help to prevent medical adverse events or ensure that they do not recur provide information that is crucial to promoting medical safety nationwide, which we can share widely with medical institutions throughout Japan. We would like to express our heartfelt gratitude to all those who, while working in busy clinical environments at medical institutions, take the time to report medical near-miss/adverse event information.

While the number of voluntarily participating medical institutions continues to grow, the number of reports from such institutions remains lower than the number from medical institutions subject to reporting requirements. The medical institutions that participate voluntarily in this project assiduously strive to ensure medical safety in their routine practice and we believe that their participation in this project is a sign of this. Once they have begun to participate, the next step is to submit reports. The focus of medical adverse event information reporting under this project is not dictated by whether or not the event was due to incorrect medical care or management, or even the extent of the impact, but also encompasses events that can help to prevent medical adverse events at medical institutions or ensure that they do not recur. Accordingly, we would greatly appreciate your cooperation in the appropriate reporting of events that fall within this scope.

The JQ will continue to strive to provide useful information based on reports from medical institutions and would therefore greatly appreciate your understanding and cooperation in this endeavor.

I2017 Annual Report

I 2017 Annual Report

I

- 5 -- 4 -


1. Number of Registered Medical Institutions and Current Reporting Status

A total of 1,473 medical institutions were participating in this project as of the end of 2017. Diagrams providing a breakdown of the number of registered medical institutions can be found in “II-1 Status of Participation in the Project to Collect Medical Near-miss/Adverse Event Information,” including the number of medical institutions reporting medical adverse event information and the number reporting medical near-miss events. These diagrams show basic data concerning the status of participation in this project and this information is updated on the website as required. It can be accessed via the “List of Registered Medical Institutions” link on the website.

A total of 4,095 reports of medical adverse event information were submitted between January and December 2017, the period covered by this Annual Report. Medical institutions subject to reporting requirements reported 3,598 of these, while voluntarily participating medical institutions reported 497. Fig. I-1 shows the number of reported events between 2005 and 2017. As the project continues to receive around the same number of reports as the previous year, if not more, we believe that the practice of reporting medical adverse events is becoming firmly established.

Fig. I-1 Number of Reports of Medical Adverse Event Information and Number of Medical InstitutionsYear 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Number of Reports

Mandatory 1,114 1,296 1,266 1,440 1,895 2,182 2,483 2,535 2,708 2,911 3,374 3,428 3,598Voluntary 151 155 179 123 169 521 316 347 341 283 280 454 497

Total 1,265 1,451 1,445 1,563 2,064 2,703 2,799 2,882 3,049 3,194 3,654 3,882 4,095

Number of Medical Institutions

Mandatory 272 273 273 272 273 272 273 273 274 275 275 276 276Voluntary 283 300 285 272 427 578 609 653 691 718 743 755 773

Total 555 573 558 544 700 850 882 926 965 993 1,018 1,031 1,049

For reference, Fig. I-2 shows the scope of events reported as medical adverse event information. As can be seen from (3), the scope encompasses events that can help to prevent medical adverse events at medical institutions or ensure that they do not recur, irrespective of whether or not the event was due to incorrect medical care or management, or the degree of effect on the patient.

Fig. I-2 Scope of Events Reported as Medical Adverse Event Information

(1) Apparent errors in treatment or management that resulted in the patient’s death or mental or physical disability, or required unexpected treatment, treatment to an unexpected extent, or other medical procedure.

(2) Unapparent errors in treatment or management that resulted in the patient’s death or mental or physical disability, or required unexpected treatment, treatment to an unexpected extent, or other medical procedure (including events possibly associated with treatment or management provided; limited to unexpected events).

(3) Other than those described in (1) and (2), information conducive to the prevention of medical adverse events and their recurrence at medical institutions.

I

- 5 -- 4 -

2 Collection of Follow-Up Information Concerning Medical Adverse Events: Overview of On-site Visits

In addition to the tables shown in the chapter “II Aggregate Reports” in this Annual Report, we recommend that you also refer to the website, which carries tables not published in the Annual Report, such as “Professional Experience of the Person Involved,” “Clinical Department Involved,” “Location of the Occurrence,” and “Nature of Event × Severity of Event.” Clicking on the “Statistics Menu (Web Data)” button on the project website brings up a list of quarterly and annual tables, which users can browse and download.

2. Collection of Follow-Up Information Concerning Medical Adverse Events: Overview of On-site Visits

Where we deem it necessary to obtain more detailed facts concerning reported events from the medical institutions concerned, we make written inquiries and, if cooperation is forthcoming, undertake on-site visits. In 2017, we made 135 requests to medical institutions for additional written information and received 131 responses. We asked five medical institutions for permission to carry out on-site visits regarding nine events and all offered us their cooperation. In particular, we believe that the on-site visits provide useful information for the promotion of medical safety, as it is possible to engage in more in-depth discussion of the details of the reported event by inquiring about the content of deliberations conducted within the institution after the report and to acquire information that it was not possible to glean at the time of the report. An overview of on-site visits is provided in “III-2 Collection of Follow-Up Information on Medical Adverse Events” in this Annual Report. Fig. I-3 provides summaries of the events that were the focus of on-site visits in 2017.

Fig. I-3 List of On-site VisitsVisit The type of event Summary of event

1

Drugs

Event in which Sandimmun Oral Solution was dispensed and administered in error instead of Neoral Oral Solution

2 Event in which drugs were over-prescribed when the prescription ordering system was switched from prescribing on the basis of amount per day to amount per time

3Event in which the drug name was entered as free text instead of being selected from the list when entering allergy information and an alert was therefore not generated when the drug was prescribed

4 Blood transfusions Event in which the wrong blood type was transfused due to an error in determining the blood type

5

Treatment/procedure

Event in which Nor-Adrenalin was administered instead of adrenaline during resuscitation

6 Event in which the person involved intended to check the outpatient’s blood test results a few days later, but forgot to do so

7 Event in which the physician checked the image from a CT examination, but failed to look at the diagnostic imaging report

8Event in which the physician continued the patient’s treatment with oral anticancer drugs without checking the laboratory data at the time of the outpatient consultation, resulting in the patient being affected

9 Drainage tubes or other tubes

Event in which the nasogastric feeding tube was inserted into the lung in error and oral medication injected into it

*The type of event is based on the item selected by the medical institution in its report.


I

- 7 -- 6 -

3. Analysis of Events1) Themes Analyzed

As shown in Fig. I-4, this project analyzes two types of theme: (1) themes selected for comprehensive analysis of both medical adverse event information and medical near-miss event information relevant to the theme collected over a six-month period; and (2) themes selected from medical adverse event information reported during the period under analysis in the quarterly report, which are then used in analyzing past events. In 2017, the themes selected for the first category were “Events Related to Inquiries About Prescriptions” and “Events Related to Intensive Care Unit Computer Systems”; details of relevant medical near-miss event information were collected and the results of analysis were published in the 50th–52nd Quarterly Reports. In the second category, nine themes were highlighted. Similar events in the past were highlighted and the analysis published along with the summary of each event, background and causal factors, and improvement measures reported by the medical institution concerned. Information such as the package inserts for the drugs or medical devices involved was also provided, as appropriate.

An overview of each theme analyzed in 2017 is provided in “III-3 Themes Analyzed” in this Annual Report. Each quarterly report provides information about the number of reported events, details of the events, an analysis of the background and causal factors, and a summary of improvement measures taken to prevent recurrence, so please refer to the 49th to 52nd Quarterly Reports for details. We hope that you will make use of the project website, which enables users to peruse and download information by theme analyzed.

Fig. I-4 Themes Analyzed

Themes Analyzed Quarterly Report

(1) Themes selected for comprehensive analysis of both medical adverse event information and medical near-miss event information relevant to the theme collected over a six-month period

[1] Events Related to Inquiries About Prescriptions (1) 50th[2] Events Related to Inquiries About Prescriptions (2) 51st[3] Events Related to Intensive Care Unit Computer Systems (1) 52nd(2) Themes selected from medical adverse event information reported during the period under analysis in the

quarterly report and used in analyzing past events[1] Events Involving Erroneous Use of a Drug in a Container in the Sterilized Area

49th[2] Events Related to Anesthesia Machines[3] Events Involving the Erroneous Administration to a Patient of a Drug Used in Drug-induced Lymphocyte

Stimulation Tests[4] Events Related to Management of Chest Drainage Bags

50th[5] Events Related to Falls From an Examination Table[6] Events Related to the Administration of Drugs Affected by Food Allergies

51st[7] Events Related to Implants for Orthopedic Surgery[8] Events Related to the Dosage of Drugs for Patients with Impaired Renal Function

52nd[9] Events Related to Migration of Open Drainage Tubes Within the Body

I

- 7 -- 6 -

3 Analysis of Events

2) Analysis of Recurrent and Similar Events

Some similar events continue to be reported even after information about medical adverse events has been provided in Quarterly Reports and Medical Safety Information, so repeated warnings are required. Accordingly, starting with the 18th Quarterly Report, we added a section entitled “Recurrence of Events and Occurrence of Similar Events” and, since the 50th Quarterly Report, have continued to analyze these events in the section “Analysis of Recurrent and Similar Events.” This analysis highlights a number of themes that were the subject of reports after we had provided information about events of a similar nature and looks at trends in the number of recurrent or similar events after the provision of information, as well as providing details of the summary of event and specific improvement measures reported by the medical institutions concerned. Fig. I-5 and Fig. I-6 show the recurrent and similar events most commonly reported in 2017 in relation to themes previously highlighted in Quarterly Reports and Medical Safety Information.

Fig. I-5 Most Commonly Reported Recurrent and Similar Events Previously Highlighted as Themes in Quarterly Reports

Summary Number of Events

Events Related to Burns (Excluding Burns Sustained During Nursing Care) 36Events Involving Failure to Communicate the Content of the Diagnostic Imaging Report 36Event Involving Gauze Left Within the Body 26Events Involving Administration of Allergic Drug to Patient with Previous Known Allergy History 21Event Involving Infarction and Hemorrhage Occurred in Patients Treated with Warfarin Potassium for the Management of Blood Coagulability 21

Event Involving Burns Sustained During Nursing Care 16Events Related to Patient or Drug Mix-up at the Time of Administration 16Events Related to Rupture of the Subcutaneous Port and Catheter 13Events Related to Wrongly Inserted Gastric Tube 12Events Involving the Wrong Site (Confusion between Right and Left) 11

Fig. I-6 Most Commonly Reported Recurrent and Similar Events Previously the Subject of Medical Safety Information

No. Title Number of Events

No.63 Inadequate Checks Concerning Diagnostic Imaging Reports 32No.58 Rupture of the subcutaneous port and catheter 13No.57 Accidental ingestion of PTP sheets

10No.82 Accidental ingestion of PTP sheets (1st Follow-up Report)No.7 Extravascular leakage in pediatric patients 9No.54 Accidental removal of the endotracheal/tracheostomy tube when changing positions 9No.80 Urethral Damage Caused by an Indwelling Bladder Catheter 8No.30 Administration of allergic drug to patient with previous known allergy history 7No.59 Burns Due to Incorrect Handling of an Electrosurgical Pencil 7No.47 Mix-up of the tooth extraction site 6No.71 Forgetting to Check the Pathologic Diagnosis Report 5No.116 Patient Mix-up in Drug Administration 5


I

- 9 -- 8 -

Table I-7 shows themes highlighted in the “Analysis of Recurrent and Similar Events” section of quarterly reports in 2017. An overview of each theme is provided in “III-4 Analysis of Recurrent and Similar Events” in this Annual Report. Each Quarterly Report sets out the number of events reported after information was provided, a summary of the events, details of the background and causal factors, and a summary of improvement measures taken, so please refer to the 49th to 52nd Quarterly Reports for details. We hope that you will make use of the project website, where users can peruse and download the Analysis of Recurrent and Similar Events for each theme.

Fig. I-7 Themes Highlighted in Analysis of Recurrent and Similar EventsQuarterly

Report Title

49thBurns Due to Incorrect Handling of an Electrosurgical Pencil (Medical Safety Information No.59)Contraindicated Combined Administration of Drugs (Medical Safety Information No.61)

50thMagnetic Material (e.g. Metal Products) Taken in the MRI Room (Medical Safety Information No.10, 1st Follow-up Report: No.94)Failure to release "standby" mode when resuming ventilation (Medical Safety Information No.37)

51stInadequate Checks Concerning Diagnostic Imaging Reports (Medical Safety Information No.63)Dead Battery in a Central Monitor Transmitter (Medical Safety Information No.95)

52ndUse of Unsterilized Medical Devices (Medical Safety Information No.19: Use of unsterile medical supplies)Events Related to the Management of Milk Formula and Breastfeeding (38th Quarterly Report)

4. Medical Safety InformationSince December 2006, the project has provided Medical Safety Information to promote the prevention of the occurrence/recurrence of medical adverse events through the provision of information that ought to be made common knowledge. Medical Safety Information is designed to be user-friendly for medical professionals in busy clinical environments. Specifically, the volume of information is narrowed down to keep the length to around two pages of A4, with illustrations and tables provided for maximum visual impact. Medical Safety Information is sent out once a month by fax to registered medical institutions participating in the Project to Collect, Analyze, and Provide Medical Adverse Event Information and the Project to Collect, Analyze, and Provide Medical Near-Miss Information, and is also published on the project website. In addition, to share this information with a wider audience, we also send it by fax free of charge to non-participating hospitals that ask to receive it. Medical Safety Information is faxed on the day of publication, enabling medical institutions to receive, circulate, and act on the information without delay.In 2017, we compiled and published Medical Safety Information No. 122–133 (Fig. I-8). The number of recurrent and similar events reported in 2017 in relation to matters previously highlighted in Medical Safety Information No.1–133 and details of the main recurrent and similar events are provided in “IV Medical Safety Information” in this Annual Report.

I

- 9 -- 8 -

5 Current Status of the Project

Fig. I-8 Medical Safety Information released in 2017Month of

information supply

No. Title

January No.122 Error in Measuring Body Weight Before DialysisFebruary No.123 Film Dressing Affixed to Permanent Tracheostomy

March No.124 Medical Safety Information released in 2016April No.125 Insufficient Understanding of Drugs to be Halted Pre-operatively —Oral Contraceptives—May No.126 Blood Sample Taken from Limb During an Infusion in the Same LimbJune No.127 Medical Safety Information released from 2013 to 2015July No.128 Wrong Site Surgery(Right/Left) —Neurosurgical Procedures—

August No.129 Contraindicated Combined Administration of Drugs (1st Follow-up Report)September No.130 Air Embolism Due to a Central Venous Line Left Open

October No.131 Misunderstanding of Insulin Units (1st Follow-up Report)November No.132 Patient Falls While Using the Overbed Table for SupportDecember No.133 Chest Drain Left Open to Air

5. Current Status of the ProjectThe chapter “V Current Status of the Project” provides various information, including details of the project website overhaul that we carried out in 2017, the number of times the website was accessed, and various initiatives undertaken using our database of events. It also outlines the supplement to the 50th Quarterly Report published in September 2017, academic conference presentations concerning this project, and our dissemination of information overseas.


I

- 10 -

IIAggregate Reports

II Aggregate Reports

- 13 -- 12 -

II


1. Status of Participation in the Project to Collect Medical Near-miss/Adverse Event Information

The Project to Collect Medical Near-miss/Adverse Event Information consists of two projects, the Project to Collect, Analyze, and Provide Medical Adverse Event Information and the Project to Collect, Analyze, and Provide Medical Near-miss Event Information.

The medical institutions participating in each project as of December 31, 2017 are shown below.

Fig. II-1-1 (YI-01) Registration Status of Medical Institutions Participating in Each Project

Registration status

Project to Collect, Analyze, and Provide Medical Near-miss Event Information

Total

Participating

Not participatingNumber of

occurrences and medical

near-miss event information

Only number of occurrences

Project to Collect, Analyze,

and Provide Medical Adverse

Event Information

Required Participating 123482

83309

70258

2761,049

Voluntary

Participating 359 226 188 773

Not participating 166 258 424

Total648 567

258 1,4731,215

The current reporting status for each project is shown in 2 Report on the Project to Collect, Analyze, and Provide Medical Adverse Event Information and 3 Report on the Project to Collect, Analyze, and Provide Medical Near-miss Event Information.

- 13 -- 12 -

II

2. Project to Collect, Analyze, and Provide Medical Adverse Event Information

The Project to Collect, Analyze, and Provide Medical Adverse Event Information gathers medical adverse event information from medical institutions subject to reporting requirements and also from voluntarily participating medical institutions that ask to participate in this project. This Annual Report provides the collated results for events reported between January 1 and December 31, 2017.

[1] Registered Medical InstitutionsThe number of medical institutions subject to reporting requirement and voluntarily participating medical institutions participating in the Project to Collect, Analyze, and Provide Medical Adverse Event Information as of December 31, 2017 is shown below. Reasons for the fluctuation in the number of medical institution include opening/closure and consolidation of hospitals as well as change of classification of the parent organization.

Fig. II-2-1 (YA-01) Number of Medical Institutions Subject to Reporting Requirement and Voluntarily Participating Medical Institutions

Parent organizationMedical institutions subject to reporting

requirement(Note 1)

Voluntarily participating

medical institutions(Note 2)

Government

National University Corporation, etc. 46 1National Hospital Organization 142 0National Research and Development Agencies 8 0National Hansen’s Disease Sanatorium 13 0Japan Organization of Occupational Health and Safety 0 31Japan Community Health care Organization 0 40Other national organizations 0 0

Municipality

Prefecture 2 20City/village 0 87Japan Association of Municipal and Prefectural Municipality Colleges and Universities 9 2

Local independent administrative institutions 1 24

Parent organization of public medical

institution other than municipality

Japan Red Cross 0 55Saiseikai Imperial Gift Foundation 0 19Hokkaido Social Welfare Association 0 2National Welfare Federation of Agricultural Cooperatives 0 18

National Health Insurance Association Federation 0 1Health Insurance Union and their associations 0 2Mutual Aid Associations and their associations 0 11National Health Insurance Society 0 0

Corporation

School juridical organization 54 12Healthcare corporation 0 312Charitable organization 1 48Company 0 12Other corporation 0 29

Individual practitioner 0 47Total 276 773

(Note 1) As of the end of December 2017, details of the medical institutions subject to reporting requirement (276 institutions) are as follows:A. National Research and Development Agencies and National Hansen’s Disease Sanatorium 21 institutionsB. National Hospital Organizations 142 institutionsC. University hospitals governed by the School Education Act (not including branch hospitals) 109 institutionsD. Special Functioning Hospitals (including those categorized as A, B or C above) 85 institutions(Note 2) Voluntarily participating medical institutions are those participating in the project other than medical institutions subject to reporting requirement.



- 15 -- 14 -

II

[2] Number of Reports(1) Number of Monthly ReportsThe number of monthly reports made by medical institutions subject to reporting requirement and voluntarily participating medical institutions between January 1 and December 31, 2017 is shown below. There were 4,095 reports in 2017.

Fig. II-2-2 (YA-03) Number of Monthly Reports Made by Medical Institutions Subject to Reporting Requirement and Voluntarily Participating Medical Institutions

2017 TotalJanuary February March April May June July August September October November December

Number of reports made by medical institutions subject to reporting requirement

260 254 338 281 300 309 245 320 308 297 381 305 3,598

Number of reports made by voluntarily participating medical institutions

69 23 36 53 28 25 43 35 53 64 32 36 497

Number of medical institutions subject to reporting requirement

276 276 276 276 276 276 277 277 277 277 277 276 -

Number of voluntarily participating medical institutions

756 758 756 761 760 764 764 766 765 768 771 773 -

(2) Medical Adverse Event Reporting Status

A. Reporting status of medical institutions subject to reporting requirementAmong medical institutions subject to reporting requirement, the number of reporting medical institutions subject to reporting requirement and the number of reports made between January 1 and December 31, 2017 are shown in Fig. II-2-3, tabulated numbers of reports made since the launch of the project by the parent organization are shown in Fig. II-2-4, those by the number of beds are shown in Fig. II-2-5, and those by region are shown in Fig. II-2-6. In addition, tabulated numbers of reporting medical institutions in the same period by number of reports are shown in Fig. II-2-7. Figures for the number of medical institutions subject to reporting requirements may not correspond to those shown in other tables, due to changes during the collection period, such as the accreditation of medical institutions as Special Functioning Hospitals or the abolition of medical institutions. As of December 31, 2017, the number of medical institutions subject to reporting requirement was 276, and the total number of beds at those institutions was 140,205.

Fig. II-2-3 (YA-04) Number of Reporting Medical Institutions Subject to Reporting Requirement and Reports Made by the Parent Organization

Parent organization

Number of medical institutions

(as of December 31, 2017)

Number of reporting medical

institutionsNumber of

reports

January to December, 2017


Government

National University Corporation, etc. 46 41 797National Hospital Organization 142 128 1,509National Research and Development Agencies 8 8 127National Hansen’s Disease Sanatorium 13 9 43

Municipality

Prefecture

12 10 329

City/villageJapan Association of Municipal and Prefectural Municipality Colleges and UniversitiesLocal independent administrative institutions

Corporation School juridical organization 54 38 773Charitable organization 1 1 20

Total 276 235 3,598

- 15 -- 14 -

II

Fig. II-2-4 (QA-05) Number of Reports Made by Medical Institutions Subject to Reporting Requirement (Accumulated Total)

Parent organizationNumber of reports

October 2004 to December 2017

Government

National University Corporation, etc. 7,105National Hospital Organization 12,825National Research and Development Agencies 1,172

National Hansen’s Disease Sanatorium 343

Municipality

Prefecture

2,120

City/villageJapan Association of Municipal and Prefectural Municipality Colleges and UniversitiesLocal independent administrative institutions

CorporationSchool juridical organization 6,824Charitable organization 64

Total 30,453

Fig. II-2-5 (YA-05) Number of Reporting Medical Institutions Subject to Reporting Requirement and Reports Made by Number of Beds

Number of bedsNumber of medical

institutions(As of December 31, 2017)

Number of reporting medical institutions Number of reports

January to December, 2017 January to December, 2017

0-19 beds 0 0 0

20-49 beds 17 6 12

50-99 beds 4 2 3

100-149 beds 8 4 18

150-199 beds 7 6 32

200-249 beds 16 11 96

250-299 beds 15 13 111

300-349 beds 28 26 229

350-399 beds 17 14 162

400-449 beds 29 29 313

450-499 beds 16 16 232

500-549 beds 11 9 93

550-599 beds 10 10 121

600-649 beds 25 22 532

650-699 beds 6 6 139

700-749 beds 11 11 177

750-799 beds 4 3 37

800-849 beds 11 10 333

850-899 beds 4 3 73

900-999 beds 12 12 235

1000 beds or more 25 22 650

Total 276 235 3,598



- 17 -- 16 -

II

Fig. II-2-6 (YA-06) Number of Reporting Medical Institutions Subject to Reporting Requirement and Number of Reports by Region

RegionNumber of medical



January to December, 2017 January to December, 2017

Hokkaido 10 7 99

Tohoku 25 22 223

Kanto/Koshinetsu 87 71 1,111

Tokai/Hokuriku 37 34 599

Kinki 36 33 451

Chugoku/Shikoku 35 32 607

Kyushu/Okinawa 46 36 508

Total 276 235 3,598

Fig. II-2-7 (YA-07) Number of Medical Institutions Subject to Reporting Requirement by Number of Reports

Number of reportsNumber of reporting medical institutions

As of December 31, 2017

0 421 162 143 104 105 96 187 108 129 1610 10

11-20 5621-30 2731-40 1241-50 451-100 8101-150 1151-200 1

200 or above 0Total 276

- 17 -- 16 -

II

B. Reporting status of voluntarily participating medical institutionsThe number of voluntarily participating medical institutions as of December 31, 2017 and reports made by those institutions between January 1 and December 31, 2017 are shown in Fig. II-2-8 and tabulated number of reports made since the launch of the project by parent organization is shown in Fig. II-2-9.

Fig. II-2-8 (YA-08) Number of Reporting Voluntarily Participating Medical Institutions and Number of Reports

Parent organizationNumber of medical





Government 72 18 50Municipality 133 36 158

Public medical institution 108 22 51

Corporation 413 64 237Individual practitioner 47 1 1

Total 773 141 497

Fig. II-2-9 (QA-10) Number of Reports Made by Voluntarily Participating Medical Institutions (Accumulated Total)

Parent organizationNumber of reports

October 2004 to December 2017

Government 209Municipality 960

Public medical institution 855

Corporation 1,801Individual practitioner 7

Total 3,832



- 19 -- 18 -

II

[3] Details of Reports Made by Registered Medical InstitutionsThis Annual Report carries some of the results compiled on the basis of medical adverse event information reports from registered medical institutions (medical institutions subject to reporting requirement and voluntarily participating medical institutions) between January 1 and December 31, 2017. Each table is compiled on the basis of the options available in the Medical Adverse Event Information Report Input Items.

Fig. II-2-10 (YA-28-C) Job Title of the Person Involved

Job title of the person involved Number of event

Doctor 2,319Dentist 64Nurse 2,520

Assistant nurse 17Pharmacist 38

Clinical engineer 26Midwife 26

Nursing assistant 23Radiological technologist 29

Clinical technologist 14Registered dietitian 1

Dietitian 1Cook/kitchen staff 1

Physical therapist (PT) 41Occupational therapist (OT) 10Speech -language -hearing

therapist (ST) 2

Medical technologist 0Dental hygienist 1

Dental technologist 0Others 56Total 5,189

* The person involved is a person determined by the medical institution to have been involved in the event occurred; more than 1 person may have been involved.

- 19 -- 18 -

II


Fig. II-2-11 (YA-35-C) Summary of EventSummary of event Number of event %

Drug 353 8.6Blood transfusion 10 0.2Treatment/procedure 1,094 26.7Medical device, etc. 98 2.4Drainage tube or other tube 279 6.8Examination 183 4.5Nursing care 1,640 40.0Others 438 10.7

Total 4,095 100.0* Regarding percentages, the totals may not become 100.0 due to rounding to the first decimal place.

Fig. II-2-12 (YA-37-C) Severity of EventSeverity of event Number of event %

Death 318 7.8High potential of residual disability 426 10.4Low potential of residual disability 1,176 28.7No potential of residual disability 1,088 26.6No disability 927 22.6Unknown 160 3.9

Total 4,095 100.0* Severity of event is not necessarily associated with occurrence of event or negligence.* “Unknown” includes indefinite outcome at the time of reporting (within 2 weeks).* Regarding percentages, the totals may not become 100.0 due to rounding to the first decimal place.

Fig. II-2-13 (YA-42-C) Events Encouraged to Be ReportedEvents encouraged to be reported Number of event %

Accident due to use of contaminated drug/material/biologic product

6 0.1

Death or disability due to nosocomial infection 5 0.1

Suicide or suicide attempt of patient 73 1.8

Disappearance of inpatient 9 0.2Burn of patient 55 1.3Electric shock of patient 0 0Death or disability of patient due to facility fire 0 0

Handling over of infant to wrong parent 1 0

No applicable option 3,946 96.4Total 4,095 100.0

* Regarding percentages, the totals may not become 100.0 due to rounding to the first decimal place.


- 21 -- 20 -

II

Fig. II-2-14 (YA-40-C) Clinical Department

Clinical department Number of event %

Internal medicine 340 6.8Anesthesiology 127 2.5Cardiovascular medicine 312 6.2Neurology 132 2.6Respiratory medicine 267 5.3Gastrointestinal medicine 347 6.9Hematology 77 1.5Circulatory surgery 34 0.7Allergy 5 0.1Rheumatism 23 0.5Pediatrics 225 4.5General surgery 419 8.3Orthopedics 625 12.5Plastic surgery 45 0.9Cosmetic surgery 0 0Neurosurgery 220 4.4Respiratory surgery 77 1.5Cardiovascular surgery 168 3.3Pediatric surgery 34 0.7Pain clinic 3 0.1Dermatology 51 1.0Urology 182 3.6Venereology 0 0Proctology 3 0.1Gynecology/Obstetrics 74 1.5Obstetrics 31 0.6Gynecology 51 1.0Ophthalmology 72 1.4Otolaryngology 105 2.1Psychosomatic medicine 1 0Psychiatry 277 5.5Rehabilitation 42 0.8Radiology 87 1.7Dentistry 12 0.2Orthodontics 0 0Pediatric dentistry 1 0Dental/oral surgery 51 1.0Unknown 9 0.2Others 491 9.8

Total 5,020 100.0* “Clinical department” may be more than one.* Regarding percentages, the totals may not become 100.0 due to rounding to the first decimal place.

- 21 -- 20 -

II

3. Project to Collect, Analyze, and Provide Medical Near-Miss Event Information

The information collected in the Project to Collect, Analyze, and Provide Medical Near-Miss Event Information consists of the information on the number of occurrences and medical near-miss event information. The number of occurrences about them is collected by all medical institutions that wish to participate in the Project to Collect, Analyze, and Provide Medical Near-Miss Event Information. This Annual Report provides collated results for the number of medical near-miss events occurring and reported between January 1 and December 31, 2017.

[1] Participating Medical InstitutionsThe number of medical institutions participating in the Project to Collect, Analyze, and Provide Medical Near-Miss Event Information as of December 31, 2017 is shown below.

Fig. II-3-1 (YH-01) Number of Participating Medical Institutions in the Project to Collect, Analyze, and Provide Medical Near-Miss Event Information

Parent organization Participating medical institutions

Participating medical institutions for

medical near-miss event information

reporting

Government

National University Corporation etc. 29 18National Hospital Organization 117 68National Research and Development Agencies 5 3National Hansen’s Disease Sanatorium 12 4Japan Organization of Occupational Health and Safety 31 26

Japan Community Health care Organization 44 23Other national organizations 0 0

Municipality

Prefecture 27 15City/village 134 74Japan Association of Municipal and Prefectural Municipality Colleges and Universities 9 5

Local independent administrative institutions 26 11

Parent organization of public medical

institution other than

municipality

Japan Red Cross 81 46Saiseikai Imperial Gift Foundation 20 10Hokkaido Social Welfare Association 1 1National Welfare Federation of Agricultural Cooperatives 20 8

National Health Insurance Association Federation 2 0Health Insurance Union and their associations 1 0Mutual Aid Associations and their associations 21 12National Health Insurance Society 1 1

Corporation

School juridical organization 49 34Healthcare corporation 421 205Charitable organization 53 23Company 11 3Other corporation 44 21

Individual practitioner 56 37Total 1,215 648



- 23 -- 22 -

II

[2] Information on the Number of Occurrences The reports of the information on the number of occurrences between January 1 and December 31, 2017 are shown below.

Fig. II-3-2 (YNR-01) Information on the Number of Occurrences

Items

Erroneous medical procedures

Total

Not performed

Performed

Effects (if actions in question had been done)

Patients would have died or had serious

conditions

Patients would have required intensive

procedure/treatment

Patients would have required minor

procedure/treatment or would not have required any procedure/treatment

(1) Drug 1,571 5,857 89,269 194,636 291,333(2) Blood transfusion 120 300 1,777 3,200 5,397(3) Treatment/procedure 450 2,149 12,555 36,891 52,045(4) Medical device, etc. 337 896 9,616 17,336 28,185(5) Drainage tube or other tube 598 1,731 23,622 103,863 129,814(6) Examination 441 1,990 27,133 50,836 80,400(7) Nursing care 536 3,366 50,258 139,075 193,235(8) Others 991 2,839 47,668 57,524 109,022Total 5,044 19,128 261,898 603,361 889,431Re-posted[1] Events involving name or dosage form of drug 197 686 5,634 12,833 19,350[2] Events caused by drug 807 3,078 34,872 80,169 118,926[3] Events caused by medical device, etc. 276 609 4,532 10,431 15,848[4] Current theme 306 2,060 28,633 9,254 40,253

Number of reporting medical institutions 600Total number of beds 234,207

[3] Number of Medical Near-miss Event Information(1) Status of Monthly Reports The number of monthly reports for medical near-miss event information between January 1 and December 31, 2017 is shown below.

Fig. II-3-3 (YH-03) Number of Monthly Reports for Medical Near-miss Event Information2017 Total

January February March April May June July August September October November December

Number of medical near-miss event information

4,937 2,262 1,404 4,757 1,893 1,648 3,856 2,003 1,208 4,305 2,157 788 31,218

Number of participating medical institutions for medical near-miss event information reporting

642 644 642 642 641 643 644 644 644 645 647 648 -

- 23 -- 22 -

II

(2) Summary of Event Fig. II-3-4 (YH-31) Summary of Event

Summary of event Number of event %

Drug 12,939 41.4Blood transfusion 108 0.3Treatment/procedure 1,180 3.8Medical device, etc. 827 2.6Drainage tube or other tube 4,406 14.1

Examination 2,014 6.5Nursing care 5,427 17.4Others 4,317 13.8

Total 31,218 100.0* Regarding percentages, the totals may not become 100.0 due to rounding to the first decimal place.



- 24 -

II

IIICurrent Analysis of Medical

Near-miss/Adverse Event Information

III III

- 27 -- 26 -

III Current Analysis of Medical Near-miss/Adverse Event Information


Both medical adverse event information and medical near-miss event information have been collected in the project launched in 2004. Since 2005, medical adverse event information and medical near-miss event information covered by individual themes have been comprehensively analyzed.

1. Project Overview[1] Information to be AnalyzedEvents with information related to predetermined themes were selected from among the medical adverse event information and medical near-miss event information reported during the period under analysis in each quarterly report and then analyzed.

In addition, if additional analysis was deemed necessary, past events outside the period under analysis in the quarterly report were selected and analyzed in the same way, after first determining the period to be examined.

[2] Analysis SystemAt meetings held once a month or so, Expert Analysis Groups consisting of medical professionals involved in medical safety and experts in safety management review the main medical adverse event information reported through this project and consider the content of themes for analysis.

Theme-specific Expert Analysis Groups are established to conduct analysis, based on the field of expertise involved in the events. This department then compiles these analyses and, after review by the Comprehensive Evaluation Panel, publishes information about the themes analyzed.

III III

- 27 -- 26 -

1. Project Overview

[3] WorkshopThe 9th Workshop on Process Flows and the Project to Collect Medical Near-miss/Adverse Event Information was held for medical institutions participating in this project, to inform them about the current status of the project and enhance the quality of reports.

(1) Overview of the Workshop 1) Workshop date: Saturday February 3, 2018 2) Workshop venue: Lecture Hall, JQ 3) Target participants: Staff from medical institutions, based on the following conditions i) – iii)

i) Multidisciplinary teams of 3 people.

ii) Teams must include someone who plays a part in medical safety at the medical institution, such as the person in charge of the Medical Safety Management Division, the Medical Safety Manager, or members of the Medical Safety Committee or Medical Safety Officers.

iii) At least 1 person with experience of using some kind of technique for analyzing medical adverse events at the medical institution should be included.

iv) As the workshop will involve preparing a process flow covering the process from prescribing an injection drug to an inpatient to dispensing, preparing, and administering that drug, participation by medical staff involved in those duties and by staff involved in preparing in-house procedure manuals is preferable.

4) Program

i) Lecture: 1) The Current Status of the Project to Collect Medical Near-miss/Adverse Event Information and its Challenges

2) The Significance of Process Flows 3) Medical Safety and Process Flows 4) Drawing up Process Flows

ii) Practice: Examining Problems in Processes at Your Own Facility and Revising the Process Flows

(2) Participation Status Number of participants: 42 people (14 medical institutions)

- 29 -

III III

- 28 -


2. Collection of Follow-Up Information on Medical Adverse Events

When an Expert Analysis Group determines that more detailed information from the medical institution is required for analysis, it makes written inquiries to the reporting medical institution or, if the institution agrees to cooperate, conducts an on-site visit. The details of additional information provided are utilized in considering medical safety measures.

[1] Collection of Follow-Up Information in WritingIn 2017, 135 written inquiries concerning medical adverse events were made to medical institutions and 131 responses were received. The breakdown of these is shown in Fig. III-2-1.

Fig. III-2-1 Breakdown of Written Requests for Follow-up InformationOverview of the event Number of events

Drugs 58Blood transfusions 0Treatment/procedure 21Medical device, etc. 9Drainage tubes or other tubes 7Examination 6Nursing care 21Others 13

Total 135

[2] Collection of Follow-Up Information via On-site VisitsMedical institutions where nine medical adverse events occurred were asked to cooperate in conducting on-site visits, and they all did so. A list of on-site visits conducted in 2017 is provided in Fig. III-2-2, while details of a few of these visits are provided in Fig. III-2-3.

Fig. III-2-2 List of On-site Visits

Visit The type of event Summary of event

1

Drugs

Event in which Sandimmun Oral Solution was dispensed and administered in error instead of Neoral Oral Solution

2 Event in which drugs were over-prescribed when the prescription ordering system was switched from prescribing on the basis of amount per day to amount per time

3 Event in which the drug name was entered as free text instead of being selected from the list when entering allergy information and an alert was therefore not generated when the drug was prescribed

4 Blood transfusions Event in which the wrong blood type was transfused due to an error in determining the blood type

5

Treatment/procedure

Events in Which Nor-Adrenalin Was Administered Instead of Adrenaline During Resuscitation

6 Event in which the person involved intended to check the outpatient’s blood test results a few days later, but forgot to do so

7 Event in which the physician checked the image from a CT examination, but failed to look at the diagnostic imaging report

8Event in which the physician continued the patient’s treatment with oral anticancer drugs without checking the laboratory data at the time of the outpatient consultation, resulting in the patient being affected

9 Drainage tubes or other tubes

Event in which the nasogastric feeding tube was inserted into the lung in error and oral medication injected into it

*The type of event is based on the item selected by the medical institution in its report.

III

- 29 -

III III

- 28 -


Fig. III-2-3 Overview of On-site Visits

Visit 6 Event in which the person involved intended to check the outpatient’s blood test results a few days later, but forgot to do so

Event as reported

Summary of event Background and causal factors Improvement measures

The patient had been on anti-hepatitis B virus drugs for 6 years 8 months due to chronic hepatitis B and underwent an abdominal ultrasound and blood tests once every three months. The physician had many similar patients under their care and usually set a date for another outpatient consultation after the blood tests and abdominal ultrasound examination had been carried out, once the results were known. As the patient had to travel a long way to the hospital, the physician carried out the examinations and consultation on the same day, with the intention of reducing the burden on the patient. Any results not available on the day of the consultation were checked about a week later by the attending physician and reported to the patient by telephone only if there were any abnormal findings. The AFP and HBV-DNA results were not available in time for the previous consultation, so the physician explained only that there were no abnormalities in the portion of the blood test results that were available at that point or in the findings from the abdominal ultrasound, and then booked the next consultation in for a date three months later. The physician was in the habit of using their smartphone’s memo function to make a note of patients whose examination results needed to be checked, but in this patient’s case, the physician forgot to check the results, possibly due to having forgotten to make a note to do so. At the consultation three months later, a liver carcinoma measuring about 4 cm was found by the abdominal ultrasound examination and the patient’s AFP had risen markedly to 33,879, so the physician reviewed the AFP from three months earlier and noticed that it had already been elevated then, at 544. An emergency CT examination was performed and a single liver carcinoma was confirmed in the S4 segment of the liver. If the AFP result from three months earlier had been noticed at an early stage, an emergency CT examination would have been carried out immediately at that point to thoroughly investigate the cause. Even if the liver carcinoma had not shown up on the image at that stage, the patient would likely have been followed up at shorter intervals and the diagnosis could possibly have been made a month or two earlier.

The physician arranged examinations and consultations on the same day for patients who had to travel a long way. Where results were not available on the day of the consultation, the physician made a note and relied on it as a reminder to check the results later on and contact the patient if there were any abnormalities. On this occasion, the physician was unable to check the AFP result at the time of the consultation (it is likely that the result would have been ready if they had waited about another 30 minutes), but because the result for HBV-DNA was going to take about another two weeks, the physician decided that it would be fine to check the AFP result later as well. However, because the physician did not make a note of this, they forgot to check the test result. The physician had forgotten to check test results before the next consultation on two or three other occasions (although in those instances, the results were not crucial) and was therefore aware of the risk of using this method, but had not changed it.

• Systems reliant upon the memory of a single physician as in this case should no longer be used.

• The following ideas have been suggested and are currently under consideration.

○ Examinations and consultations should not take place on the same day; consultation dates should be set once all the examination results are available.

○ If examination results will be available on the day, the patient should be asked to wait until the results are available, so that the results can be explained to them face to face.

○ If examination results will be available on the day, the patient’s record should be held in “consultation suspended” mode.

○ If it is absolutely impossible for a patient to return for a consultation at a later date to be briefed on the results of the examination, the patient should make inquiries by telephone or other means, or a dummy consultation booking should be made the following week in preparation.

○ A system should be created to ensure that abnormally elevated laboratory data are reported to the physician by the laboratory as panic values.

III


- 30 -

III III

- 31 -

Details of the On-site VisitAttendees from the Medical Institution

Deputy Hospital Director & Director of the Medical Safety Management Division, Medical Safety Manager (nurse), Pharmaceutical Safety Management Officer and Deputy Director of Pharmacy (pharmacist), clerical staff

Findings1. Lead-up to the event: Explained by the medical institution (set of documents provided by the medical institution)

• The patient had to travel 2 hours to reach the hospital from their home.• Patient’s AFP levels

6 months earlier: 23 months earlier: 544 H ← Physician forgot to look at the result.Now: 33,879 H ← Physician noticed that it was high.

2. Background and causal factors○ Physicians

• The examination results were copied and pasted into the electronic medical record for the date of the consultation three months earlier, along with the note “AFP To be confirmed.”

• The physician usually set one date for the blood test, abdominal ultrasound, and any other examinations required, and then booked a consultation on another day once the results were known. However, the physician arranged examinations and consultations on the same day for patients who had to travel a long way.

• If any results were not going to be available on the day, the physician made a note on their smartphone and contacted the patient by telephone if it was urgent.

• The physician had forgotten to make a note two or three times in the past, but in those cases, the examination results were not crucial. The physician was aware of the risk of forgetting, but continued to use the same method.

○ Response to panic values• The medical institution has specified that the indicators and criteria needing to be reported as panic values include figures

for hepatic and renal function, blood glucose, electrolytes, and hemoglobin indicative of an emergency.• Separate panic value reporting processes have been established for inpatients and outpatients.• Panic values have not been set for tumor markers, as these are difficult to determine.

3. Main improvement measures introduced after reporting the event• The ideas listed in the improvement measures at the time the event was reported are still under consideration.• The medical institution decided to adhere to the practice of examinations being carried out on a separate date, with

consultations taking place once the results were available.• The view was expressed that it would be advisable to prohibit contacting patients by telephone, in order to protect personal

information and prevent errors.

Discussion during the visit, etc. (○: Visitor, ●: Attendees from the Medical Institution)○ Some medical institutions hand over a sheet of paper with the laboratory data at the time of the outpatient consultation. If a result

is not available, the relevant space is left blank or the words “To be confirmed” are printed in it, making it easier to tell that the patient has not been told the result. Printing off the laboratory data and handing it over to the patient can increase the patient’s own interest in the results, which can assist with patient education.

● Enlisting the patient’s assistance was one idea put forward when the hospital was considering improvements. However, it was decided to make the appointments for examinations and consultations on different days.

○ It appears that patients were only contacted about the results in the event of any abnormalities, but patients therefore interpreted the physician’s failure to contact them as meaning that everything was fine, so it would be desirable to introduce a system under which patients are also contacted if everything is fine.

○ It is usual for panic values to be set at levels requiring treatment to be provided as an emergency. In contrast, tumor markers are used to reach a diagnosis promptly. Accordingly, while it is difficult to set panic values for tumor marker levels, it might be advisable to adopt an approach in which a report is triggered if a figure in the laboratory data is x times higher than in the previous examination.

● As tumor markers differ according to each patient’s progress, we believe that it is difficult to specify a uniform level. This would place a burden on the clinical laboratory, so we are moving forward with discussions focused on making contact only if a figure clearly indicates a problem.

○ This particular patient’s PIVKA-II does not seem to have been being measured, but it might be necessary to examine not only AFP, but also PIVKA-II and to look at the laboratory data from a more integrated perspective.

○ As stated in the improvement measures, it would be wise to have a system that ensures that someone notices anomalous values, rather than individual physicians having to do their best to remember to look.

● We believe that continued discussion is needed about the figures to be set and methods of communication to be used to ensure that the clinical laboratory contacts physicians.

○ It would be helpful to know how staff within the hospital were made aware of this event.● We made staff aware of this event at a workshop for all staff.

- 30 -

III III

- 31 -

Visit 7 Event in which the physician checked the image from a CT examination, but failed to look at the diagnostic imaging report

Event as reported


About a year earlier, the patient had been seen by the general medical check-up department. An abdominal ultrasound had indicated an abdominal aortic aneurysm and the patient’s PSA level had also been flagged as being high, so the patient was referred to and seen by the department of cardiovascular medicine for thorough examination of the abdominal aortic aneurysm and by the department of urology as an outpatient regarding his high PSA level. The outpatient attending physician in the department of cardiovascular medicine (the same physician who carried out the general medical check-up) performed an abdominal contrast CT examination a month later to thoroughly examine the abdominal aortic aneurysm. At the time of the outpatient consultation seven days after the CT examination, the physician wrote the finding “Check aortic aneurysm and check renal function in six months” on the patient’s record and booked a blood test and abdominal ultrasound examination. The abdominal ultrasound examination carried out in the course of an outpatient visit four months later resulted in the finding “No significant changes in the abdominal aortic aneurysm, no problems with the kidneys.” An abdominal ultrasound examination carried out during a complete medical check-up for lifestyle diseases another seven months later resulted in the finding “suspected renal cell carcinoma.” When another physician conducting health check-ups looked back over the past laboratory findings, they discovered that the comment “suspected renal cancer, for thorough examination” in the findings from the abdominal contrast CT examination carried out about 11 months earlier had been overlooked.

The physician in charge of health check-ups was also the attending physician in the department of cardiovascular medicine who requested the examination (holding both posts concurrently) and had the preconceived notion that, based on the results of the abdominal ultrasound and urinary cytodiagnosis carried out at the time of the health check-up, there should be no important renal findings. The attending physician in the department of cardiovascular medicine ordered an abdominal contrast CT examination for thorough examination of the aortic aneurysm, but, being confident in their own ability to interpret images in their field of specialism, did not look at the interpretation of the image by the radiology department. The patient was referred to the outpatient attending physician in the urology department by the general medical check-up department on the grounds of high PSA and underwent a pelvic MRI examination and another PSA test to thoroughly examine the prostate, but the physician did not notice the findings from the other examination (abdominal contrast CT examination). The patient’s renal cancer was found to be a type of tumor that is difficult to detect by means of an abdominal ultrasound examination.

• It might be possible to build a system that sends the attending physician a warning of some kind from the radiology department if an imaging examination leads to the discovery of an abnormal finding other than the purpose of the examination or in a location other than the organ on which the examination focuses.

• Some kind of double-check mechanism will be put in place in outpatient departments for checking examination results.

• The physician in the general medical check-up department was also the outpatient attending physician in the department of cardiovascular medicine to which the patient was referred for follow-up of the abdominal aorta and that physician did not look at anything other than the abdominal aorta, due to their own assumptions. Accordingly, patients will, in future, be referred to a different physician, to serve as a double-check.


III III

- 33 -- 32 -



Deputy Hospital Director & Director of the Medical Safety Management Division, Medical Safety Manager (nurse), Pharmaceutical Safety Management Officer and Deputy Director of Pharmacy (pharmacist), clerical staff

Findings1. Lead-up to the event: Explained by the medical institution (set of documents provided by the medical institution)

• The department handling complete medical check-ups is separate from the usual clinical departments, so if anything is found in a complete medical check-up that requires thorough examination, the patient is referred to the relevant clinical department in the medical institution. On this occasion, the physician who noticed the abdominal aortic aneurysm in the complete medical check-up was also the physician who saw the patient as an outpatient in the department of cardiovascular medicine.

• The diagnostic imaging report for the abdominal contrast CT examination was prepared on the day of the examination and noted the following regarding the patient’s kidneys.

[Findings] Kidneys: A tumor shadow x mm in diameter can be seen on the right kidney. Renal cancer is suspected. For thorough examination.[Diagnosis] Right kidney tumor shadow (with an image indicating the site in question with an arrow)

2. Background and causal factors○ Cardiologist (medical examiner for the complete medical check-up)

• Although the diagnostic imaging report was available when the results of the abdominal contrast CT examination were explained a week after it had been performed, the cardiologist cannot remember whether or not they looked at the report.

• There is a possibility that the cardiologist saw the statement “Right kidney tumor shadow” in the diagnosis section of the diagnostic imaging report for the abdominal contrast CT examination, but did not check it properly because the cardiologist knew that a “benign tumor (renal cyst)” had been pointed out on the kidney during the complete medical check-up a month earlier.

○ Urologist• As the patient had been referred due to a high PSA reading, the urologist retested the PSA level and carried out a pelvic

MRI examination. When doing so, the urologist did not look at the diagnostic imaging report for the abdominal contrast CT examination requested by the department of cardiovascular medicine. As the MRI examination focused on the pelvis, the kidneys were not visible in the image.

○ Systems involving radiologists• There were seven radiologists involved in preparing diagnostic imaging reports.• The radiologists make 28,000 diagnoses per year for CT examinations alone, preparing and sending out diagnostic imaging

reports.• Other than for emergency examinations, the radiologists prepare and send out diagnostic imaging reports the same day as

the imaging examination.• Any findings requiring an urgent response or emergency treatment (such as a rapid increase in pleural effusion or

pneumothorax) were communicated to the physician by telephone. However, there was no system for communicating findings of cancers other than those that were the focus of the imaging.

○ Electronic medical record functions relating to diagnostic imaging reports• The relevant diagnostic imaging report can be searched for by date on the screen listing all the reports and can then be

opened to view by clicking on the report in question.• The electronic medical record at the medical institution did not have the following functions.

◇ A function notifying the requesting physician that the diagnostic imaging report had been prepared and sent◇ A function enabling the user to determine whether or not the diagnostic imaging report had been opened◇ A function enabling the fact that the content of the diagnostic imaging report has been checked to be recorded

3. Main improvement measures introduced after reporting the event• “Building a system that sends the attending physician a warning of from the radiology department” and “Putting in place a

double-check function for examination results in outpatient departments,” which were listed in the improvement measures at the time the event was reported are still under consideration.

• The medical information department is trialing a system in which it uses the following procedure to check cases where the diagnostic imaging report is suspected to have been overlooked.1) Select cases where the diagnostic imaging report contains the keywords “thorough examination.”2) Check whether the required thorough examinations have been carried out as ordered.3) Use the electronic medical record e-mail function to warn the attending physician if the required thorough examinations

have not been carried out as ordered.

III III

- 33 -- 32 -

Discussion during the visit, etc. (○: Visitor, ●: Attendees from the Medical Institution)○ Even if the physician who ordered the examination had looked at the pathologic examination and imaging examination reports,

it is difficult to spot findings other than those in the physician’s field of interest. It would be helpful to know whether a system has been put in place for enabling the radiology or pathology departments to contact the physician.

● We want to create a system that enables the individual who notices any unexpected findings from pathologic or imaging examinations to contact the attending physician, but we have not yet been able to secure cooperation for this, as some have expressed the view that it will impose greater responsibility on the radiology and pathology departments. However, we are considering instituting a procedure for telephoning the clinical department that ordered the examination in the event of any unexpected findings.

○ One option might be to devise some way of drawing attention to the words “thorough examination” on the diagnostic imaging report, perhaps by displaying them in a different color.

○ Some medical institutions have approached the issue by changing the order in which findings are displayed on the diagnostic imaging report, so that any unexpected findings are given first.

○ The diagnosis section of this particular diagnostic imaging report stated “Right kidney tumor shadow,” but it might be advisable to make it clear that the tumor is malignant in such cases.

● The physicians who order examinations want the reports to show at a glance whether a tumor is malignant, but we wish to continue considering this matter as we are still discussing it with the radiologists.

○ Radiologists might report findings more readily if the requesting physician thanked them for reporting any unexpected findings. It might also be advisable to count the number of findings identified in areas other than the specific area of interest as an indicator of doing a good job.

● It appears that when the radiology department contacts a clinical department, the response from the person contacted is sometimes “I’m busy right now.” We believe that reporting would be easier if there was a mechanism in which reporting unexpected findings had a positive effect.

○ At some other medical institutions, radiologists not only prepare reports, but also enter them on the electronic medical record.○ It is wonderful that the hospital’s system is such that diagnostic imaging reports are provided on the day of the imaging

examination itself. However, this presumably places a considerable burden on the radiologists, given the size of the hospital. It might be wise to consider the size of the workforce in comparison with other institutions based on various documents and the like, as well as ascertaining the number of CT and other imaging examinations carried out per year and the number of radiologists, and then calculating the number of diagnostic imaging reports prepared per radiologist per day.

● As well as interpreting images from examinations, the radiologists are involved in such procedures as interventional radiology and, given the number of examinations carried out at this hospital, would appear to be very busy. As we did not consider this point, we would like to examine it going forward.

○ As this kind of event could occur in various clinical departments, it would appear necessary to make all hospital staff aware of it.● We reported it at a meeting of risk managers and a management committee meeting, and considered response measures. In

addition, we made staff aware of this event at a workshop for all staff.


III III

- 35 -- 34 -


Visit 9 Event in which the nasogastric feeding tube was inserted into the lung in error and oral medication injected into it

Event as reported


The physician inserted a nasogastric feeding tube and ordered an X-ray, which was taken with a portable machine. The physician checked the tube using the display on the portable X-ray machine and ordered the nurse to inject oral medication. When the nurse listened for bubbling sounds in the stomach, they were faint, so the nurse asked the lead nurse to listen. The lead nurse also found that the sounds were faint and was concerned about injecting the medication, so they reported the situation to the physician. The physician also checked the bubbling sounds in the stomach and confirmed that they could be heard, albeit faintly. Because the physician had also checked the X-ray image, they decided that it was fine and verbally reissued the order to inject the oral medication. As the physician had reissued the order, the nurse slowly injected 40 mL of liquid, consisting of 20 mL of dissolved oral medication and 20 mL of a 1:10 dilution of vinegar in water. Immediately afterward, the patient’s SpO2 only rose from the upper end of the 80% range to the lower end of the 90% range. The patient complained of respiratory discomfort and their air intake into the right lung declined. At about the same time, the radiological technologist, who had returned to the X-ray room, contacted the physician to tell them that the tube had been inserted into the lung in error. The physician contacted the nurse immediately, but the oral medication had already been injected. The nurse immediately recovered about 50 mL of stomach contents and attempted oxygen inhalation, suction, and postural drainage. The physician hurried to the patient and removed the nasogastric feeding tube. SpO2 soon recovered, but the patient then required treatment with antibiotics and insertion of a thoracostomy tube.

While providing treatment on the ward, the physician needed to deal with an emergency outpatient, so checked the display on the portable X-ray machine, whereas they would normally have checked the display on the desktop. The physician permitted the nasogastric feeding tube to be used without adequate checks. In addition, the nasogastric feeding tube used was thinner than normal, so it was hard to check on the portable X-ray machine’s display. The manual prohibits checks based on bubbling sounds from the stomach alone, due to the frequency of misidentification, but the nurse did not use another method to check, such as suction of stomach contents. Although the physician checked the X-ray image, the nurse did not check it themselves.

• Thorough awareness of and compliance with the manual will be ensured and staff will undergo retraining based on past events involving the incorrect insertion of nasogastric feeding tubes.

III III

- 35 -- 34 -


Hospital Director, Deputy Hospital Director (in charge of medical safety), Nursing Director, nurse working full-time in the Medical Safety Measures Office, head nurse of the ward involved, clerical staff

Findings1. Lead-up to the event: Explained by the medical institution (set of documents provided by the medical institution)2. Background and causal factors

○ Manual• The chapter of the Medical Safety Manual entitled “1. Ensuring the safety of drains and tubes” has sections covering gastric

tubes (nasal), and gastrostomies/enterostomies. The Medical Safety Manual is a manual for all staff.• The sections on gastric tubes (nasal), and gastrostomies/enterostomies are divided into two: (1) After inserting the gastric

tube, and (2) Before injecting enteral nutrients through the gastric tube.(1) After inserting the gastric tube, check points (i)-(iii) in the following order:

(i) Check the oral cavity (ensure that the tube is not twisted)(ii) Suction stomach contents(iii) X-ray imagingThe precautions in the manual state “Do not base judgments on listening for bubbling sounds from the stomach, because these are frequently misidentified” and “Mark the tube to show how far it should be inserted.”

(2) Before injecting enteral nutrients through the gastric tube, check points (i)-(iii):(i) Check the oral cavity (ensure that the tube is not twisted)(ii) Check the site of the marking(iii) Suction stomach contentsThe manual also states “Check points (i)-(iii), because bubbling sounds from the stomach are frequently misidentified” and “If you cannot check these points, use an abdominal X-ray to check the position.”

• The physician and nurses on the ward had not been adequately informed of the content of the Medical Safety Manual.○ Compliance with the manual

• The nurses on the ward were often unable to suction stomach contents, so routinely checked by listening for bubbling sounds from the stomach.

○ Check using the display• There was an awareness that the display on the portable imaging machine was for checking the quality of the image.• The desktop screen is usually used to check the image when checking the position of nasogastric feeding tubes, but the

attending physician needed to deal with an outpatient and so used the display on the portable imaging machine, because they were able to view the image immediately after taking it.

• The display screen was not saved, so it is unclear what the image looked like.○ Attending physician

• The patient had suffered a cerebral infarction and dysphagia, but was lucid and was thought to be at little risk of accidental aspiration, so a thinner nasogastric feeding tube than usual was chosen. The 8Fr tube was inserted to a length of 47 cm. When inserting the nasogastric feeding tube, the physician felt that it was hard to insert, because the shape of the patient’s stomach was distorted.

• When the physician checked the bubbling sounds from the stomach because the nurse reported that they could hear different sounds from usual, they felt that the sound was faint.

• The physician did not use any other method to check, such as suctioning stomach contents.• Even after the physician was able to take a break from dealing with the outpatient, they did not use the desktop screen to

check the position of the nasogastric feeding tube.○ Nurse

• After the X-ray was taken, the physician, the nurse, and the radiological technologist looked at the image on the display of the portable imaging machine together, so they thought that they had confirmed the position of the nasogastric feeding tube. They felt that the tip of the nasogastric feeding tube was over toward the right-hand side of the abdomen, but the physician replied, “It’s because the patient’s stomach is distorted,” so the nurse assumed that the tube had been inserted into the stomach.

• When listening for bubbling sounds in the stomach, the nurse felt that they were not as audible as usual, but did not check the X-ray image on the desktop screen, because they had checked the position of the nasogastric feeding tube on the display of the portable imaging machine.

• After receiving the order from the physician that the nasogastric feeding tube could be used, the nurse dissolved Bayaspirin in 20 mL of water and injected it, and then injected 20 mL of a 1:10 dilution of vinegar in water. When the nurse carried out suction because the patient had produced a large quantity of saliva after the medication was injected, the nurse could see a pale yellowish fluid in the nasogastric feeding tube around the nasal cavity, but thought it was gastric fluid.

○ Radiological technologist• After the X-ray was taken, the radiological technologist checked the image on the display of the portable imaging machine,

but did not see the position of the nasogastric feeding tube.3. Main improvement measures introduced after reporting the event

• The event was shared as a sentinel event at a meeting of the Medical Safety Measures Committee.• Strenuous efforts were made to ensure full awareness of the Medical Safety Manual among physicians.• Strenuous efforts were made to ensure full awareness of the Medical Safety Manual and warnings among nurses via

meetings of section chiefs, who serve as risk managers on each ward.


III III

- 37 -- 36 -


Discussion during the visit, etc. (○: Visitor, ●: Attendees from the Medical Institution)○ There is literature stating that, as a rough guide, the length of nasogastric feeding tube that should be inserted is about the

patient’s height × 0.3 + 10 cm. It might be advisable to refer to this as a guide for the length of tube that should be inserted. This patient was about 150 cm tall, so that would make the length to be inserted approximately 55 cm.

○ As small capnometers and other devices for measuring CO2 in exhaled air are available, it might be wise to purchase and use these.

○ When choosing nasogastric feeding tubes, it might be wise to choose items which ensure that the whole length of the tube can easily be seen in the X-ray image.

○ Some physicians do not know that one of the procedures for checking that the nasogastric feeding tube has been inserted into the stomach is “Suction stomach contents,” so it would seem necessary to ensure that physicians are fully aware of the method of checking insertion of the tube by suctioning stomach contents.

○ When checking X-ray images, it is advisable to check that the tip of the nasogastric feeding tube is lower than the diaphragm; that the nasogastric feeding tube passes close to the median line of the thorax; that the nasogastric feeding tube transects the tracheal carina or bronchi (does not pass through the airway); and that the nasogastric feeding tube passes close to the median line of the diaphragm.

○ When checking the position of a nasogastric feeding tube on the desktop screen, it should be possible to change the screen display conditions, etc. to check it if the position of the tube is hard to identify.

● The instruction manual for the portable imaging machine states that the quality of images shown on the portable imaging machine’s display cannot be guaranteed. We are currently considering how to notify staff of the details.

○ It might be wise to revise the Medical Safety Manual and stipulate that the image should not be checked using the display on the portable imaging machine. It might also be advisable to use various opportunities to communicate this information, such as meetings of the Medical Equipment Safety Management Committee, rather than merely placing the issue on the agenda of the Medical Safety Measures Committee.

○ 20 mL of vinegar diluted in water was being injected 1 time/day, but there is no clear evidence that this prevents drugs from adhering to the inside of the nasogastric feeding tube. There have been cases in the past at other hospitals of acetic acid being wrongly injected instead of vinegar. It might be advisable to consider the purpose of injecting diluted vinegar.

○ No report was made by the attending physician. It might be advisable to consider the reporting system.○ No method can guarantee that a nasogastric feeding tube will not be wrongly inserted and there are cases in which it is difficult

to do everything in the clinical environment. It is probably most important to comply with the method specified by the hospital.

III III

- 37 -- 36 -

3. Themes Analyzed[1] Selection of Themes for Information to be AnalyzedThis project endeavors to use the data reported to provide information that will help to prevent medical adverse events and ensure that they do not recur. Accordingly, themes are selected for information to be analyzed and events associated with that theme are analyzed and examined. The themes have been selected based on expert opinions and in light of 1) generality/universality, 2) event frequency, 3) effect on patients, 4) preventability, and 5) ability to serve as an object lesson.

This project’s Quarterly Reports analyze two types of theme: (1) themes selected for comprehensive analysis of both medical adverse event information and medical near-miss event information relevant to the theme collected over a six-month period; and (2) themes selected from medical adverse event information reported during the period under analysis in the quarterly report, which are then used in analyzing past events.

[2] Themes Analyzed in 2017Fig. III-3-1 lists the themes analyzed in the 49th to 52nd Quarterly Reports, which were published in 2017. Clicking on the [Analysis Themes] (http://www.med-safe.jp/contents/report/analysis.html) button on the project website brings up a list of themes taken up for analysis in each quarterly report, enabling users to browse through the relevant PDFs.

Fig. III-3-1 Themes Analyzed in 2017Themes Analyzed Quarterly Report

(1) Themes selected for comprehensive analysis of both medical adverse event information and medical near-miss event information relevant to the theme collected over a six-month period

[1] Events Related to Inquiries About Prescriptions (1) 50th[2] Events Related to Inquiries About Prescriptions (2) 51st[3] Events Related to Intensive Care Unit Computer Systems (1) 52nd(2) Themes selected from medical adverse event information reported during the period under analysis in

the quarterly report and used in analyzing past events[1] Events Involving Erroneous Use of a Drug in a Container in the Sterilized Area

49th[2] Events Related to Anesthesia Machines[3] Events Involving the Erroneous Administration to a Patient of a Drug Used in Drug-induced

Lymphocyte Stimulation Tests[4] Events Related to Management of Chest Drainage Bags

50th[5] Events Related to Falls From an Examination Table[6] Events Related to the Administration of Drugs Affected by Food Allergies

51st[7] Events Related to Implants for Orthopedic Surgery[8] Events Related to the Dosage of Drugs for Patients with Impaired Renal Function

52nd[9] Events Related to Migration of Open Drainage Tubes Within the Body

Discussion during the visit, etc. (○: Visitor, ●: Attendees from the Medical Institution)○ There is literature stating that, as a rough guide, the length of nasogastric feeding tube that should be inserted is about the

patient’s height × 0.3 + 10 cm. It might be advisable to refer to this as a guide for the length of tube that should be inserted. This patient was about 150 cm tall, so that would make the length to be inserted approximately 55 cm.

○ As small capnometers and other devices for measuring CO2 in exhaled air are available, it might be wise to purchase and use these.

○ When choosing nasogastric feeding tubes, it might be wise to choose items which ensure that the whole length of the tube can easily be seen in the X-ray image.

○ Some physicians do not know that one of the procedures for checking that the nasogastric feeding tube has been inserted into the stomach is “Suction stomach contents,” so it would seem necessary to ensure that physicians are fully aware of the method of checking insertion of the tube by suctioning stomach contents.

○ When checking X-ray images, it is advisable to check that the tip of the nasogastric feeding tube is lower than the diaphragm; that the nasogastric feeding tube passes close to the median line of the thorax; that the nasogastric feeding tube transects the tracheal carina or bronchi (does not pass through the airway); and that the nasogastric feeding tube passes close to the median line of the diaphragm.

○ When checking the position of a nasogastric feeding tube on the desktop screen, it should be possible to change the screen display conditions, etc. to check it if the position of the tube is hard to identify.

● The instruction manual for the portable imaging machine states that the quality of images shown on the portable imaging machine’s display cannot be guaranteed. We are currently considering how to notify staff of the details.

○ It might be wise to revise the Medical Safety Manual and stipulate that the image should not be checked using the display on the portable imaging machine. It might also be advisable to use various opportunities to communicate this information, such as meetings of the Medical Equipment Safety Management Committee, rather than merely placing the issue on the agenda of the Medical Safety Measures Committee.

○ 20 mL of vinegar diluted in water was being injected 1 time/day, but there is no clear evidence that this prevents drugs from adhering to the inside of the nasogastric feeding tube. There have been cases in the past at other hospitals of acetic acid being wrongly injected instead of vinegar. It might be advisable to consider the purpose of injecting diluted vinegar.

○ No report was made by the attending physician. It might be advisable to consider the reporting system.○ No method can guarantee that a nasogastric feeding tube will not be wrongly inserted and there are cases in which it is difficult

to do everything in the clinical environment. It is probably most important to comply with the method specified by the hospital.

3. Themes Analyzed

III III

- 38 -


4. Analysis of Recurrent and Similar EventsThe 3rd to 17th Quarterly Reports featured a section entitled Medical Adverse Event Information to Be Shared, which provided a summary of events that the Expert Analysis Groups thought should be shared with a wider audience after consideration of individual medical adverse event information reports. In addition, a section entitled Individual Theme Review appeared in the 1st to 49th Quarterly Reports and was renamed Themes Analyzed from the 50th Quarterly Report. Highlighting a specific theme, this section analyzes and examines events related to that theme. Based on events previously profiled in the Medical Adverse Event Information to Be Shared or Individual Theme Review sections, the project also publishes Medical Safety Information, which provides information that should be common knowledge.

This section summarizes the number of recurrent and similar events relating to themes profiled in the Quarterly Reports and content highlighted in Medical Safety Information. It also lists the themes highlighted in 2017.

[1] Recurrent and Similar Events Highlighted in 2017The Analysis of Recurrent and Similar Events section of the 49th to 52nd Quarterly Reports, which were published in 2017, highlighted major events about which reports had been received again, looking at trends in the number of recurrent or similar events that occurred between the provision of information and the period under analysis in the quarterly report in question, and also detailing specific improvement measures reported by the medical institutions concerned. Fig. III-4-1 lists the contents of each quarterly report. Clicking on the [Analysis of Recurrent and Similar Events] (http://www.med-safe.jp/contents/report/similar.html) button on the project website brings up the titles of the analyses of recurrent and similar events in each quarterly report, enabling users to browse through the relevant PDFs.

Fig. III-4-1 Themes Highlighted in Analysis of Recurrent and Similar Events in 2017Quarterly

Report Title

49thBurns Due to Incorrect Handling of an Electrosurgical Pencil (Medical Safety Information No.59)Contraindicated Combined Administration of Drugs (Medical Safety Information No.61)

50thMagnetic Material (e.g. Metal Products) Taken in the MRI Room (Medical Safety Information No.10, 1st Follow-up Report: No.94)Failure to release "standby" mode when resuming ventilation (Medical Safety Information No.37)

51stInadequate Checks Concerning Diagnostic Imaging Reports (Medical Safety Information No.63)Dead Battery in a Central Monitor Transmitter (Medical Safety Information No.95)

52ndUse of Unsterilized Medical Devices (Medical Safety Information No.19: Use of unsterile medical supplies)Events Related to the Management of Milk Formula and Breastfeeding (38th Quarterly Report)

IVMedical Safety Information

IV

IV Medical Safety Information

- 41 -- 40 -

IV Medical Safety InformationIn December 2006, the Project to Collect Medical Near-miss/Adverse Event Information began to prepare Medical Safety Information bulletins for both medical institutions participating in the project and the wider public, to provide information about which knowledge should be particularly widespread. This Medical Safety Information is provided by fax and also via the project website.

1. Summary[1] ObjectiveThe objective of this service is to provide participating medical institutions with information that ought to be made common knowledge, based on the information reported to the Project to Collect Medical Near-Miss/Adverse Event Information, to assist in preventing the occurrence/recurrence of medical adverse events.

[2] Medical Institutions Receiving Information by FaxMedical Safety Information is provided to about 6,000 medical institutions:

1) Medical institutions subject to reporting requirements as well as voluntarily participating medical institutions in the Project to Collect, Analyze, and Provide Medical Adverse Event Information

2) Participating medical institutions in the Project to Collect, Analyze, and Provide Medical Near-miss Event Information

3) Medical institutions that have requested that information be provided by fax

IV

- 41 -- 40 -

2. Content of the Information Provided

2. Content of the Information ProvidedMedical Safety Information bulletins No.122 to No.133 were issued between January and December 2017 (Fig. IV-2-1).

Fig. IV-2-1 Medical Safety Information released in 2017Month of

information supply

No. Title

January No.122 Error in Measuring Body Weight Before DialysisFebruary No.123 Film Dressing Affixed to Permanent Tracheostomy

March No.124 Medical Safety Information released in 2016

April No.125 Insufficient Understanding of Drugs to be Halted Pre-operatively —Oral Contraceptives—

May No.126 Blood Sample Taken from Limb During an Infusion in the Same LimbJune No.127 Medical Safety Information released from 2013 to 2015July No.128 Wrong Site Surgery(Right/Left) —Neurosurgical Procedures—

August No.129 Contraindicated Combined Administration of Drugs (1st Follow-up Report)September No.130 Air Embolism Due to a Central Venous Line Left Open

October No.131 Misunderstanding of Insulin Units (1st Follow-up Report)November No.132 Patient Falls While Using the Overbed Table for SupportDecember No.133 Chest Drain Left Open to Air

IV

IV Medical Safety Information

- 42 -

- 42 -

VCurrent Status of the Project

- 45 -- 44 -

V Current Status of the Project

V


1. Dissemination of Information about the ProjectBased on the project plan, the project prepares and publishes Quarterly Reports, the Annual Report, and monthly Medical Safety Information bulletins, as well as providing a database of events and holding workshops. The pamphlet “Project Activities and How to Participate” (http://www.med-safe.jp/pdf/business_pamphlet.pdf) provides a user-friendly introduction to the project and the information provided on the website (available in Japanese only).

2. Project Website1) Website Redesign

The project’s website provides a variety of information, including a list of registered medical institutions, quarterly and annual reports, analyses of themes, analyses of recurrent and similar events, and Medical Safety Information, as well as a searchable database of events. As the project has continued, the volume of its output has grown, with website users forced to click multiple buttons to reach the content that they are looking for. Accordingly, at the end of March 2017, we redesigned the website to make it more convenient to use, by such means as enabling one-click access to key information. The website is now also compatible with smartphone screens, so that users can access project output from various handheld devices.

Fig. V-1 Statistics Menu Page (available in Japanese only)

- 45 -- 44 -

V

2) Website Access Frequency by Year

The project compiles figures for the number of times each part of the website is accessed each year. We have compiled figures for the number of times that visitors clicked on the Homepage, Event Search, Medical Safety Information, and Quarterly and Annual Reports buttons on the website between January and December 2017.

The homepage was accessed 401,528 times in 2017 (Fig. V-2). Event Search was accessed 64,700 times, Medical Safety Information 144,853 times, and Quarterly and Annual Reports 35,723 times (Fig. V-3). Access to the website has been increasing year by year, and we saw a substantial rise in the figures in 2017. Factors likely to have contributed to this increase include the revamp of the website at the end of March, the change in the screen design, and the fact that the site has become smartphone-compatible.

Fig. V-2 Homepage Access Frequency

240,165

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

450,000

263,075

20152014

270,425

2016

401,528

2017

Fig. V-3 Event Search, Medical Safety Information, and Quarterly and Annual Report Page Access Frequency

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

20152014 2016 2017

Event Search Medical Safety Information Quarterly and Annual Report

- 47 -- 46 -


V

We also investigated how many times each Medical Safety Information issued between January and December 2017 was accessed. Fig. V-4 shows which of those issues had the highest access fi gures. The number of times an issue is accessed often increases over the course of the month of publication and the following month, and then gradually declines from the third month after publication. Accordingly, fi gures for the Medical Safety Information bulletins issued in November and December 2017 are lower. Consequently, it is necessary to bear in mind that these results do not necessarily signify that they were the Medical Safety Information bulletins most frequently viewed in 2017. The issues with the highest access fi gures in 2017 were No.126 “Blood Sample Taken from Limb During an Infusion in the Same Limb” (May), No.125 “Insuffi cient Understanding of Drugs to be Halted Pre-operatively —Oral Contraceptives—” (April), and No.129 “Contraindicated Combined Administration of Drugs (1st Follow-up Report)” (August).

Fig. V-4 Medical Safety Information Accessed the Most in 2017

No.Month of

information supply

Title Access Frequency

No.126 May, 2017 Blood Sample Taken from Limb During an Infusion in the Same Limb 23,825

No.125 April, 2017 Insuffi cient Understanding of Drugs to be Halted Pre-operatively —Oral Contraceptives— 22,190

No.129 August, 2017 Contraindicated Combined Administration of Drugs (1st Follow-up Report) 22,110No.122 January, 2017 Error in Measuring Body Weight Before Dialysis 19,006No.124 March, 2017 Medical Safety Information released in 2016 18,588No.127 June, 2017 Medical Safety Information released from 2013 to 2015 16,861No.123 February, 2017 Film Dressing Affi xed to Permanent Tracheostomy 16,860No.131 October, 2017 Misunderstanding of Insulin Units (1st Follow-up Report) 16,326No.130 September, 2017 Air Embolism Due to a Central Venous Line Left Open 15,845No.128 July, 2017 Wrong Site Surgery (Right/Left) —Neurosurgical Procedures— 15,185

Fig. V-5 Medical Safety Information Accessed the Most in 2017: Medical Safety Information No.126 “Blood Sample Taken from Limb During an Infusion in the Same Limb”


Medical SafetyInformation

Project to Collect Medical Near-Miss/Adverse Event Information

Medical Safety Information, Project to Collect Medical Near-Miss/Adverse Event Information; No.126, May 2017

No.126, May 2017

Three cases have been reported in which a blood sample was taken from a limb while the patient was receiving an infusion via a peripheral venous line in the same limb, affecting the laboratory data (information collection period: from January 1, 2013 to March 31, 2017). The information is compiled based on “Individual Theme Review” (p.136) in the 10th Quarterly Report.

Blood Sample Taken from Limb During an Infusion in the Same Limb

Image of case 1Treatment Ordered or Carried Out

Right arm

Administration of Humulin R

10 units

Site of Sample

Collection

The patient had undergone breast cancer surgery and a sign stating “Do not use the right arm to take blood samples or measure blood pressure” was at the head of the patient’s bed

The staff member was concentrating on taking the blood sample and did not notice that the patient was receiving an infusion

The patient had a PIC catheter indwelling in the left arm

Excessive insulin therapy

Administration of Calcicol

/GI therapy

Not specified

Left arm

Examination Result Background

Blood glucose level

656mg/dL

Rise in bloodglucose level

Potassium 7.8mEq/L

Sodium 110mEq/L The staff members did not

know that taking a blood sample from a limb during an infusion could affect the examination results

Cases have been reported in which a blood sample was taken from a limb while the patient was receiving an infusion via a peripheral venous line in the same limb, affecting the laboratory data and resulting in treatment that the patient did not actually need being ordered or carried out.

No.126, May 2017Medical SafetyInformation



Blood Sample Taken from LimbDuring an Infusion in the Same Limb

* As part of the Project to Collect Medical Near-Miss/Adverse Event Information (a Ministry of Health, Labour and Welfare grant project), this medical safety information was prepared based on the cases collected in the Project as well as on opinions of the “Comprehensive Evaluation Panel” to prevent the occurrence and recurrence of medical adverse events. See quarterly reports and annual reports posted on the Japan Council for Quality Health Care website for details of the Project.http://www.med-safe.jp/

* Accuracy of information was ensured at the time of preparation but cannot be guaranteed in the future.* This information is intended neither to limit the discretion of healthcare providers nor to impose certain obligations or responsibilities on them.

Department of Adverse Event PreventionJapan Council for Quality Health Care1-4-17 Kandamisaki-cho, Chiyoda-ku, Tokyo 101-0061 JAPANDirect Tel: +81-3-5217-0252 Direct Fax: +81-3-5217-0253http://www.med-safe.jp/

When taking a blood sample, Night Nurse A avoided the left arm, in which the patient had an indwelling PIC catheter, and instead took the blood sample from the right arm, in which the patient was receiving an infusion via a peripheral venous line. The physician ordered a re-examination after being informed by the clinical laboratory department that the patient’s results showed panic values of 110mEq/L for sodium and 7.8mEq/L for potassium. Nurse B, who received the order, again took the blood sample from the patient’s right arm. As the results of the second examination also showed panic values, the physician administered Calcicol and GI (glucose-insulin) therapy. Subsequently, the physician noticed that a padded adhesive bandage of the kind applied after taking a blood sample was attached to the patient’s right arm and realized that the blood sample had been collected from the right arm while the patient was receiving an infusion in the same arm. Nurses A and B did not know that taking a blood sample from a limb during an infusion could affect the examination results.

Case 2

All staff at the hospital will be made fully aware of the possibility that taking a blood sample from a limb in which a patient is receiving an infusion could affect the laboratory data.

Preventive measures taken at the medical institutions in which the events occurred

If examination results show abnormal values, staff will determine the need for treatment based on an assessment of the patient’s condition.

When taking a blood sample from a patient who had undergone breast cancer surgery, Nurse A saw that there was a sign stating “Do not use the right arm to take blood samples or measure blood pressure” at the head of the patient’s bed, so Nurse A took the blood sample from the left arm, in which the patient was receiving an infusion via a peripheral venous line. One hours later, Nurse B received a report from the clinical laboratory department that the patient’s blood glucose level had risen to 656mg/dL. Nurse B reported this to the attending physician and, having received an order to administer Humulin R 10 units, prepared the drug and went to the patient’s room. When Nurse B explained to the patient that insulin was to be administered, the patient asked why their blood glucose had risen and the nurse noticed that the blood sample had been taken from the left arm, in which the patient was receiving an infusion.

Case 1

- 47 -- 46 -

V

3) Use of Information

(i) Use of Events in Pharmaceutical Company Initiatives

Previous Quarterly and Annual Reports have highlighted the fact that pharmaceutical companies have used the Event Search functions of this project and the Project to Collect and Analyze Pharmaceutical Near-Miss Event Information when issuing warnings about mix-ups between drugs with similar names, such as Norvasc and Nolvadex. Thus, reports of events to this project continue to be a catalyst for companies and relevant groups other than the JQ to provide specific warnings aimed at preventing medical adverse events. We highlight initiatives by such companies in the lectures that we give about this project overseas and these voluntary safety measures by Japanese companies are consequently attracting attention.

The following provides a summary of warnings issued by pharmaceutical companies that were highlighted in Quarterly Reports in 2017. Please refer to the relevant Quarterly Report for details.

Fig. V-6 Warnings Issued by Pharmaceutical Companies in 2017Quarterly

Report Warning Date of Issue Company Name

50th Caution Regarding Mix-ups Due to the Similarity in Brand Names Between Nolvadex® and Norvasc® May, 2017 AstraZeneca K.K.

Pfizer Japan Inc.

51st Caution Regarding Mix-ups Due to the Similarity in Brand Names Between Zytiga® Tablets and Zalutia® October, 2017

Janssen Pharmaceutical K.K.AstraZeneca K.K.Eli Lilly Japan K.K.Nippon Shinyaku Co., Ltd.

52nd Caution Regarding Mix-ups Due to the Similarity in Brand Names Between Theodur® and Tegretol®* November, 2017

Mitsubishi Tanabe Pharma CorporationSun Pharma Japan Ltd.

*An event reported to the Project to Collect and Analyze Pharmaceutical Near-Miss Event Information was used.

(ii) Use of Quarterly Reports in Initiatives by Medical Device Manufacturers and Distributors

In the 43rd Quarterly Report, this project highlighted Events Related to Central Venous Catheter Procedures on Patients in a Sitting Position and analyzed cases of air embolism when handling a central venous catheter (http://www.med-safe.jp/pdf/report_2015_3_T002.pdf). Content from this Quarterly Report was subsequently cited in package inserts for some central venous catheters.

The following provides a summary of package inserts for medical devices that were highlighted in Quarterly Reports in 2017. Please refer to the relevant Quarterly Report for details.

Fig. V-7 Package Inserts for Medical Devices Highlighted in Quarterly ReportsQuarterly

ReportName of

Medical Device Company Name Company Name

49th BardPort TiMedicon, Inc.

[Precautions for Use]1. Important Basic Precautions(7) Ensure that the patient is in a supine position when removing this product.[There is a risk of causing an air embolism if it is removed while the patient is in a sitting position.]

[References]Project to Collect Medical Near-miss/Adverse Event Information, Japan Council for Quality Health Care 43rd Quarterly Report; December 22, 201550th Power-Trialysis

- 49 -- 48 -


V

(iii) Use of the Event Database in Academic Activities

The database of medical near-miss/adverse event information published by this project has been used as a source of information for books, academic papers, articles, and materials used in awareness-raising activities. Searching the database of medical near-miss/adverse event information for events relevant to a particular specialty can also yield information that is useful for educating specialist physicians and other medical personnel. We will continue to raise awareness of this precious database of medical near-miss/adverse event information that we have amassed concerning various clinical fields in Japan, to ensure that it is even more widely used for educational purposes in various academic activities associated with the promotion of medical safety.

The 52nd Quarterly Report highlights an example of the use of the project’s event database in a study published in an academic journal.

3. Supplement to the 50th Quarterly ReportThe quarterly reports that this project has published since 2005 reached a milestone in September 2017 with the publication of the 50th Quarterly Report. To mark this occasion, we put together a supplement to the 50th Quarterly Report, in which we looked back over the Medical Safety Information provided to date and examined changes in the number of recurrent and similar events reported. The supplement also highlighted the most commonly reported recurrent and similar events previously the subject of Medical Safety Information and recurrent and similar events reported in 2016.

We hope that medical institutions will take advantage of this opportunity and make use of this publication in their initiatives focused on preventing medical adverse events and near-miss events, as well as in staff training on the theme of events repeatedly reported across the country.

Fig. V-8 Number of Reports of Recurrent and Similar Events Previously the Subject of Medical Safety Information (by Year) (Partial Extract)

Fig. V-9 Most Commonly Reported Recurrent and Similar Events Previously the Subject of Medical Safety Information

- 49 -- 48 -

V

Fig. V-10 Example of a Medical Safety Information Bulletin Regarding Which Many Reports of Recurrent and Similar Events Were Subsequently Received

4. Publication of the English-language Editions of the 2016 Annual Report and Medical Safety Information No.120-131

An English-language edition of the Annual Report has been compiled and published on the website every year since the 2005 Annual Report. At the end of March 2018, we published the English translation of this project’s 2016 Annual Report, entitled “Project to Collect Medical Near-miss/Adverse Event Information 2016 Annual Report.” It can be viewed and downloaded from our website.

We also publish English-language versions of the Medical Safety Information for readers overseas. They are made available worldwide via the Canadian Patient Safety Institute’s Global Patient Safety Alerts project. The English editions of Medical Safety Information No.120 to No.131 were published at the end of March 2018 (Fig. V-11) and can be found on the project website’s English page. We hope that you will make use of them.

Fig. V-11 English Editions of Medical Safety Information Published at the End of March 2018No. Title in English

No.120 Administration of the Wrong Drug from a Syringe Not Labeled with the Drug NameNo.121 Wrongly Inserted Nasogastric Feeding TubeNo.122 Error in Measuring Body Weight Before DialysisNo.123 Film Dressing Affixed to Permanent TracheostomyNo.124 Medical Safety Information released in 2016No.125 Insufficient Understanding of Drugs to be Halted Preoperatively －Oral Contraceptives－No.126 Blood Sample Taken from Limb During an Infusion in the Same LimbNo.127 Medical Safety Information released from 2013 to 2015No.128 Wrong Site Surgery (Right/Left) －Neurosurgical Procedures－No.129 Contraindicated Combined Administration of Drugs (1st Follow-up Report)No.130 Air Embolism Due to a Central Venous Line Left OpenNo.131 Misunderstanding of Insulin Units (1st Follow-up Report)

- 51 -- 50 -


V

5. Presentations at the Conference of the Japanese Society for Quality and Safety in Healthcare

This project takes advantage of various opportunities to provide information about such matters as the medical near-miss/adverse event information reported and the results of its analysis. At the 12th Conference of the Japanese Society for Quality and Safety in Healthcare, which was held on November 25 and 26, 2017, we held a symposium entitled “Sharing and Using Medical Adverse Event Information: Improving the Quality of Event Reports,” with the objective of encouraging the sharing and use of such information. First, a representative of the project explained its current status, the process of compiling its output, the information required for analysis, and examples of the use of the event search function. Yumi Arai of Kitasato University Hospital then gave a presentation focused on initiatives by medical institutions, which looked at the provision of medical adverse event information from the perspective of reporting institutions. Next, Junko Ayuzawa of Kyushu University Hospital explained the sharing and use of medical adverse event information and the like from the perspectives of members of the Expert Analysis Groups and Comprehensive Evaluation Panel. Shigeru Fujita from Toho University then presented the findings of a study concerning the use of Medical Safety Information at medical institutions and the effects thereof. Finally, a representative of the project explained that accurate reporting of the brand names of drugs and medical equipment is particularly important in improving those products.

6. Partnership with ISQua (International Society for Quality in Health Care)

1) ISQua’s Projects

ISQua (the International Society for Quality in Health Care) (http://www.isqua.org/) is an international society dedicated to improving the quality of healthcare, which was established in 1985 and currently has its headquarters in Dublin (Ireland). It is funded by the membership fees of individual and institutional members in around 70 countries, as well as by contributions from the Irish government. In addition to the JQ’s institutional membership of ISQua, a number of JQ executives and staff hold individual membership of the society. ISQua’s main activities are as follows:

- The International Accreditation Programme (IAP)

- Publication of the International Journal for Quality in Health Care

- Education programs aimed at improving the quality of health care (ISQua Education)

- Holding the International Conference

The JQ was awarded accreditation under ISQua’s International Accreditation Programme (IAP) in 2013, both for its Hospital Standards, which were recognized as Accredited Standards, and as an Accredited Organization. In July 2017, the JQ underwent an examination for the purpose of renewing its accreditation. The JQ is therefore itself internationally accredited as a third-party organization operating a third-party hospital evaluation program and a logo attesting to this fact is printed on its Certificates of Hospital Accreditation.

2) Participation in the 34th ISQua Conference

ISQua held its 2017 conference in partnership with the Health Foundation of the UK at the Queen Elizabeth II Center in the Westminster district of London between Sunday, October 1 and Wednesday, October 4, 2017. The theme of the 34th conference was “Learning at the System Level to Improve Healthcare Quality and Safety” (https://isqua.org/Events/london-2017). Attended by more than 1,500 people from around 80 countries, it was the largest ISQua conference yet, with approximately 700 poster presentations. Ten representatives of the JQ attended and gave nine presentations, covering this project, the Project to Collect and Analyze Pharmaceutical

- 51 -- 50 -

V

Near-Miss Event Information, Hospital Accreditation, the management of the Japan Obstetric Compensation System for Cerebral Palsy, and the EBM Medical Information Network Distribution Service. As well as events relating to dental care, the presentations regarding this project focused on the content of workshops held by the project and the results of questionnaires conducted among workshop participants. The following lists the presentations about the project given by representatives of this department. Details of the presentations can be found in the 51st Quarterly Report.

Fig. V-12 Presentations at the 34th ISQua ConferenceTitle Speaker Presentation Format

Presentations on the Project to Collect Medical Near-miss/Adverse Event InformationCreation of Preventive Measure of Adverse Event in Dental Care Through the Adverse Event Reporting / Learning System in Japan Shin Ushiro Poster

Interprofessional Workshop on Work Process Flow Chart Aimed at Improving Patient Safety Misa Sakaguchi Poster

Presentations on the Project to Collect and Analyze Pharmaceutical Near-Miss Event InformationPrevention of Wrong Medication Through Enhanced Clarification by Pharmacist on Questionable Prescription Shin Ushiro Speech

7. Dissemination of Information OverseasDue to growing attention from overseas, the JQ and this project have many opportunities to give lectures and moderate conferences. We will continue to participate in shaping international trends in medical safety and strive to exert a positive influence through the JQ’s projects focused on the quality and safety of medical care and Japanese achievements in the field of medical safety activities.

Fig. V-13 lists the overseas conferences relating to medical safety attended by us in 2017. At the 2nd Ministerial Summit on Patient Safety in Bonn, Germany, it was decided that the following fiscal year’s summit would be held in Tokyo, so the JQ was subsequently involved in preparing for the meeting as a co-organizer. Details of the specific matters covered at each meeting can be found in the relevant Quarterly Report

Fig. V-13 International Conferences Attended in 2017Quarterly

Report Conference Schedule City

49th18th Healthcare Accreditation Thai National Forum 15-17 Mar, 2017 Bangkok,

Thailand2nd Ministerial Summit on Patient Safety 29-30 Mar, 2017 Bonn, Germany

51st5th Anniversary Meeting of the Taiwan Patient Safety Culture Club and Meeting to Launch Patient Safety Movement Foundation Activities in Taiwan

3 Jun, 2017 Taichung, Taiwan

52nd

Sixth Meeting on Health care Quality Improvement in Asia-Pacific 23-24 Nov, 2017 Seoul, KoreaWHO Global Knowledge Sharing Platform for Patient Safety (GKPS) - 2017 experts meeting for the collaborative design of the GKPS 27-28 Nov, 2017 Florence, Italy

WHO Global Patient Safety Community (Webinar) 28 Nov, 2017 Florence, Italy12th Risk Management Forum in Healthcare 29 Nov, 2017 Florence, Italy

- 52 -


V

8. WorkshopsIn FY2017, the project held the 9th Workshop on Process Flows and the Project to Collect Medical Near-miss/Adverse Event Information in February 2018. Every year, this project holds workshops on the analysis of medical adverse events, to promote high-quality reporting. The workshops held to date have focused on the use of root cause analysis (RCA) and the preparation of process flows. The FY2017 workshop focused on the preparation of process flows. Preparing process flows helps to visualize the processes carried out at medical institutions, thereby facilitating consideration of how to minimize the risk of medical adverse events without waste or excessive effort. The workshop program and participants’ responses to the questionnaire are shown in Appendix 1.

9. Requests for LecturesIn response to requests from medical institutions, pharmacies, and related groups, we give lectures explaining the current status of the project and the content of its output, such as the Quarterly Reports, Annual Reports and Medical Safety Information. Each year, we give around 50 lectures, both within Japan and overseas. We aim to accept as many requests as possible, so if any representatives of medical institutions or related groups would like us to give a lecture, please do contact us.

10. Role as a Support Organization in the Medical Adverse Event Investigation System and Involvement in the System

The medical adverse event investigation system based on the Medical Care Act began operating in 2015. Like this project, this is a publicly funded system operated pursuant to laws and regulations with the objective of preventing the recurrence of medical adverse events. The JQ has been officially announced to be a “medical accident investigation support organization” as part of the medical adverse event investigation system under the Act. Specifically, the JQ has responded to requests for support from medical institutions by giving speeches about the system’s achievements and its relationship to this project. The June 2016 revision of the system provided for in the Act saw the introduction of central- and local-level support organization liaison committees. The JQ participates as a member of the central-level Support Organization Liaison Committee. In 2017, the JQ compiled and published two Recommendations for Preventing Recurrence under the medical adverse event investigation system. Both recommendations stated that details of events used had been obtained from the Event Search section of the project website.

Date of publication: October 2, 2018


2017 Annual Report

Edited and published by: Division of Adverse Event Prevention, Japan Council for Quality Health Care Toyo Building 1-4-17 Misaki-cho, Chiyoda-ku, Tokyo 101-0061, Japan Tel: +81-3-5217-0252


2017 Annual Report

October 2, 2018



ISBN978-4-902379-78-5

Project to C

ollect Medical N

ear-miss/A

dverse Event Inform

ation 2016 Annual R

eport


2017 Annual Report

October 2, 2018



ISBN978-4-902379-78-5

Project to C

ollect Medical N

ear-miss/A

dverse Event Inform

ation 2016 Annual R

eport

Project to C

ollect Medical N

ear-miss/A

dverse Event Inform

ation2017 Annual R

eport

project to collect medical near-miss/ adverse event information … · institutions reporting...

Documents