Medical Care Safety Management Guidelines

1 General Provisions

1-1 Basic principles

Acting as a clinical study specialist medical institution with study subjects' safety as our highest priority, our clinic seeks to create an environment that allows participation in clinical studies with peace of mind and, by conducting high-quality clinical studies, to contribute to the clinical development of new drugs and thereby to society.

Achieving this goal requires that our staff members work as one to raise awareness of medical safety and to reinforce the capabilities of both individuals and the organization to prevent errors. To clarify these initiatives and to enforce medical safety management and the prevention of medical errors at our clinic, we hereby establish these Shinanozaka Clinic Medical Care Safety Management Guidelines.

1-2 Definition of terms

Definitions of the main terms used in these guidelines are as follows.

(1) Medical errors

Undesirable incidents that occur to study subjects during the course of a clinical study (excluding adverse events caused by investigational drugs, etc.), including events considered force majeure, regardless of whether staff is at fault.

(2) Staff

Employees of all occupational types working at the clinic, including physicians, nurses, pharmacists, laboratory technicians, and administrative staff

(3) Medical Care Safety Promoter

An employee who possesses knowledge and skills necessary for medical care safety management and who, by appointment by the Director, is primarily in charge of medical care safety management for the clinic overall (synonymous with Medical Care Safety Manager; the same applies hereinafter).

2 Medical Care Safety Management Committee

(1) Establishment of the Medical Care Safety Management Committee

The clinic will establish a Medical Care Safety Management Committee to comprehensively plan and implement medical care safety management measures within the clinic. The Medical Care Safety Management Committee will also serve as a Nosocomial Infection Control Committee.

(2) Composition of Committee members

The composition of the Medical Care Safety Management Committee will be as follows, with the names and positions of members notified publicly within the clinic.

• (i) Director (serving as the Chair of the Committee)
• (ii) Medical Care Safety Promoter
• (iii) Nosocomial Infection Manager
• (vi) Person Responsible for Medical Device Safety Management
• (v) Persons appointed by the Director

(3) Committee duties

The main duties of the Medical Care Safety Management Committee are as follows.

• (i) Convening of Medical Care Safety Management Committee meetings
• (ii) Examination of cases obtained through reporting systems for safety management involving medical care, formulation of measures to prevent recurrence of errors, and communication of measures to staff
• (iii) Planning of medical error prevention activities and medical care safety management training within the clinic
• (iv) Other matters necessary for safety management

(4) Operation of the Committee

The operation of the Medical Care Safety Management Committee will be as follows.

• (i) The Committee will be convened about once per month as a general rule and will otherwise be convened as appropriate and necessary.
• (ii) The Committee may be convened in conjunction with other committees, etc.
• (iii) After the Committee has been convened, a summary of the proceedings will be promptly prepared and kept for five years.

3 Improvement Measures for Ensuring Safety Related to Medical Care Based on Reports, etc.

(1) Collection of information based on reports

In order to examine cases of medical errors that have occurred or that have nearly occurred and to collect information necessary for the formulation of measures that contribute to the improvement of quality of medical care in the clinic and the prevention of the occurrence and recurrence of errors, all staff members will report medical errors, etc. in accordance with the following points.

(i) Reports, etc., from staff members

Staff members who encounter a situation corresponding to any of the following will promptly make a written report following the stipulated format.

(a) Medical errors

In the event of an undesirable incident (excluding adverse events caused by investigational drugs, etc.) occurring to a study subject, regardless of whether the medical caregiver side is at fault, the matter will be immediately reported to the Chair of the Medical Care Safety Management Committee (the Director of the clinic).

(b) Cases that did not result in a medical error but in which it is thought that delay in discovery, response, etc., could have had a harmful effect on study subjects

These will be promptly reported to the Chair of the Medical Care Safety Management Committee (the Director of the clinic).

(c) Other conditions considered dangerous in everyday work

These will be promptly reported to the Chair of the Medical Care Safety Management Committee (the Director of the clinic).

(ii) Handling of reported information

The Director and other persons in managerial positions must not subject staff members to disadvantageous treatment for the reason of having made a report.

(2) Consideration of improvement measures based on reports

To contribute to improving the quality of medical care in the clinic, the Medical Care Safety Management Committee will use information collected in accordance with the preceding paragraph for the following purposes.

• (i) To examine cases of medical errors that have occurred or that have nearly occurred, to formulate measures to prevent the occurrence or recurrence of errors, and to make these known to staff
• (ii) To evaluate whether error prevention measures formulated according to (i) above are reliably implemented in all departments and are effective in the prevention of errors and the improvement of the quality of medical care

4 Preparation of Guidelines and Manuals for Safety Management

After putting these guidelines into operation, the Director will prepare specific manuals, etc., indicated below, and will review these as necessary. Any preparation of or changes to manuals will be reported to the Medical Care Safety Management Committee and made known to all staff members.

• (1) Nosocomial infection countermeasure guidelines
• (2) Manuals for the safe use of pharmaceuticals
• (3) Emergency response manuals
• (4) Other

5 Training for Medical Care Safety Management

(1) Implementation of training for medical care safety management

Training in medical care safety management for staff members is to be conducted twice a year. Staff members must make their best efforts to undergo the training when it is conducted. When training is conducted, an outline of the training (dates and times conducted, attendees, and training content) is to be recorded and kept for five years.

(2) Aims of training

The purpose of training will be to enhance safety awareness among individual employees and to enhance medical care safety throughout the clinic by making basic concepts of medical care safety management and specific methods for error prevention known to all staff members.

(3) Methods of training

Training will be conducted through methods including lectures by physicians, etc., briefings within the clinic, case analysis, lessons by invited outside lecturers, reporting sessions on outside seminars and workshops, and readings of relevant literature, etc.

6 Response in the Event of Error

(1) Life-saving measures as the highest priority

• (i) In the event of an undesirable incident occurring to a study subject, regardless of whether the medical caregiver side is at fault, the incident will first be reported to the Director or an alternative physician, and every effort will be made through the collective capabilities of the clinic to save the life of the study subject and to prevent the spread of damage.
• (ii) Collaborative structures are to be checked on a regular basis so that the cooperation of nearby medical institutions can be readily obtained in an emergency.

(2) Determination of the clinic's response policy

When determining a response policy after receiving a report, the Director may urgently convene the Medical Care Safety Management Committee as necessary to hear the opinions of the parties concerned.

(3) Explanations to study subjects, family members, and bereaved kin

Following the occurrence of an error, the Director will explain the status of the error, recovery measures currently underway, the outlook for the situation, etc., to the study subject, the subject's family members, etc., in good faith, as quickly as possible and to the extent that does not interfere with the execution of life-saving measures.

In the event of the death of a study subject due to error, the objective facts of the situation will be promptly explained to the bereaved kin. The facts and content of said explanation will also be entered into medical records, etc.

7 Other

7-1 Communication of these guidelines

The content of these guidelines will be thoroughly made known to all employees by the Director, the Medical Care Safety Promoter, the Medical Care Safety Management Committee, etc.

7-2 Review and amendment of these guidelines

• (1) The Medical Safety Management Committee will take up a review of these guidelines as an agenda item and consider it about once a year as a general rule.
• (2) These guidelines may be amended through decision by the Medical Care Safety Management Committee.

7-3 Viewing of these guidelines

Staff will strive to share information, including the contents of these guidelines, with study subjects and respond to any requests for viewing from study subjects, their family members, etc. The Medical Care Safety Promoter will respond to inquiries about these guidelines.

7-4 Response to requests for consultation from study subjects

In response to requests for consultation from study subjects regarding medical condition, etc., physicians will respond in good faith and discuss the matter as necessary with the Director, the Medical Care Safety Promoter, the person responsible for the clinical study consultation desk, etc.