Medical-care Safe Management Guidelines

1. General
1-1 Basic Philosophy
The goal of our Clinic is to create an environment in which trial subjects can undergo safe clinical study without anxiety and provide clinical trials of good quality, thereby contributing to the development of pharmaceutical products. In order to achieve this goal, it is necessary for us to reinforce our ability to prevent any accident from occurring from both individual and organizational viewpoints; and with the united effort of all our staff members under the leadership of the principal investigator. With an aim to clarify these challenges and to make known to everyone the necessity to perform the safe management of clinical trials and prevent any medical accidents in our Clinic, we hereby set forth P-one Clinic Medical-care Safe Management Guidelines.
1-2 Definitions of Terms
The meaning of the terms used in these Guidelines is as follows:
(1) Medical accidents
Any undesirable events arising in patients in the course of a clinical study including those deemed to be force majeure, regardless of whether or not our staff is at fault.
(2) Staff members
Everyone working for our Clinic such as physicians, nurses, pharmacists, laboratory technicians and office workers.
(3) Medical safety promoter
A staff member having knowledge and skills required for the management of medical safety, who is a principal investigator-appointed person engaging chiefly in the management of medical safety at the Clinic-wide level (synonym for ‘medical safety manager’ hereinafter defined accordingly) whether exclusive or non-exclusive.
2. Medical-care Safe Management Committee
(1) Establishment of a medical-care safe management committee
In order to comprehensively plan and put into practice measures for medical safety management at our Clinic, we create a medical-care safe management committee. It should be noted that this committee serves as hospital-acquired infection task forces, as well.
(2) Composition of the committee
The medical-care safe management committee is comprised of:
  1. (a) a.Principal investigator, who chairs the committee;
  2. (b) Physician, who holds the position of next-in-line to the principal investigator;
  3. (c) Representative of the nursing department;
  4. (d) Representative of the administrative department;
  5. (e) a.Medical safety promoter, when available at our Clinic. (Doubling by other positions is acceptable.); does this mean other people (nurses, doctors) can be Medical Safety Promoter, if no medical safety promoter is available?
  6. (f) Other person(s)
(3) Roles of the committee
The major roles of the medical-care safe management committee are given below:
  1. (a) To hold medical-care safe management committee meetings (about 3 times a year)
  2. (b) To examine cases being disclosed through a reporting system aiming at safety management (pertaining to medical care, etc.), in order to develop preventive measures and to make such actions known to every staff member
  3. (c) To plan and work out in-hospital medical accident prevention measures and medical safety management training programs
  4. (d) To discuss other matters necessary for the sake of safety management.
(4) Steering the committee
The medical-care safe management committee is steered in a fashion given below:
  1. (a) The committee meeting is to be held approximately three times a year and on an as-needed basis.
  2. (b) The committee meeting may be held together with any other regular committee meeting.
  3. (c) Promptly after the committee meeting, minutes are to be taken and the minutes thus taken are to be retained for two (2) years.
3. Improvement Policy Aimed at Ensuring Medical Safety Based on Reporting
(1) Information collection based on reporting
With the aim of collecting information required for examining medical accidents including near-accident cases, improving the quality of medical care at our Clinic, working out measures for avoiding any medical accident and preventing a recurrence of such accident, each and every staff member is obliged to report medical and other accidents in accordance with the guidelines given below:
(a) Reporting from staff members:
When coming across any of the following situations, the staff members are supposed to report it promptly in writing using a predetermined form. It should be noted that the report is prepared based on health records and nursing records.
(1) Medical accidents
⇒ When any undesirable event arises in a subject, regardless of our Clinic’s negligence, the chairperson of the medical-care safe management committee (i.e. principal investigator) is informed immediately after the occurrence of the event.
(2) Cases in which a delay in the discovery of any undesirable event and countermeasures to it are believed to be the potential cause of a harmful effect on a subject, although it did not lead to a medical accident
⇒ The chairperson of the medical-care safe management committee
(i.e. principal investigator) is informed without delay.
(3) Other situations considered dangerous in the daily activities
⇒ The chairperson of the medical-care safe management committee
(i.e. principal investigator) is informed accordingly.
(b) Handling of information reported
The principal investigator and other staff who hold a managerial position do not treat unfavorably those staff members who make reports about a given undesirable event, due to he or she making a report as such.
(2) Consideration of remedial measures based on the contents of the report
The medical-care safe management committee uses information thus gathered in accordance with the preceding paragraph for the purposes below so that the information contributes to the improvement of the quality of medical care at our Clinic:
  1. (a) To examine not only medical accidents that have already occurred but also near-accident cases, work out measures for avoiding any medical mishaps and preventing a recurrence of such mishaps and make them known to each and every staff member.
  2. (b) To check up on and evaluate whether the above-mentioned remedial measures have been steadily put into action at the individual in-hospital departments and whether they have actually become effective.
4. Creation of Guidelines and Manuals for Safe Management Purposes
After putting these guidelines into operation, the principal investigator creates specific manuals shown below with the active cooperation of many staff members, and works to review them, as needed. The medical-care safe management committee is notified of the creation of (or amendment to) the manuals each time it arises and one makes such creation or amendment known to each and every staff member.
  1. a. Guidelines for action in case of hospital-acquired infection * required by rule
  2. b. Manual for safe use of drugs * required by rule
  3. c. Others
5. Training for Medical-care Safe Management Purposes
Conduct of training for medical-care safe management purposes:
The principal investigator conducts a training for medical-care safe management purposes for all staff members about twice a year in accordance with a training program previously drawn up at the medical-care safe management committee. The staff members are expected to do their utmost to take part in the training when it is made available and when the training is implemented, the outline of the contents (date & time of training, names of participants and training items) is written down and the record is retained for two (2) years.
Aim of training:
The aim of training is to make the basic concepts for medical-care safe management and specific techniques for accident avoidance known to all staff members, thereby raising the individual staff’s awareness about safety and also increasing medical safety at our Clinic in its entirety.
Method of training:
Training is conducted in the form of: a lecture by the principal investigator, a briefing session in the medical office, case analysis, a lecture by a visiting lecturer, a briefing session about a lecture meeting and a training session held outside or brief reading of helpful literature and so forth.
6. Countermeasures to Accidents
Top priority of life-saving measures
  1. a. When any undesirable event arises in a subject, regardless of our Clinic’s negligence, first of all, the principal investigator or a physician who takes the place of the director is informed and then, we do our utmost to save the subjects' life and suppress the spread of further damages/injuries with a united effort by all our Clinic staffs.
  2. b. Collaborative relationships with neighboring medical institutions should be maintained on a routine basis so that we will be able to obtain cooperation from these medical institutions in a quick and efficient manner, in case of emergency.
Decision about countermeasure policies at our Clinic
The principal investigator who has been informed is entitled to convene an impromptu medical-care safe management committee meeting on an as-needed basis and seek opinions of the people involved before deciding on the countermeasure policies.
Explanation to trial subjects, family members, and family of the deceased
After the occurrence of an accident, the principal investigator must provide a sincere and frank explanation regarding the accidents’ circumstances, ongoing measures taken for recovery, outlook for it, etc., to the trial subjects and their family as quickly as possible, unless such action affects the accomplishment of the lifesaving measure. In case a subject has died in a medical accident, the principal investigator explains the actual circumstances to the family of the deceased without delay.
7. Miscellaneous
7-1 Awareness of these guidelines
The contents of these guidelines are made known to all staff members by the principal investigator, the medical safety promoter and/or the medical-care safe management committee.
7-2 Review of and amendments to these guidelines
  1. a. The medical-care safe management committee takes up a review of these guidelines as a topic of discussion at its meetings at least once each year.
  2. b. Any amendment to these guidelines is made by the medical-care safe management committee.
7-3 Direct access to these guidelines
Staff members work to share information with subjects including the contents of these guidelines and when asked by a subject or his/her family for direct access to these guidelines, they will comply. As far as any inquiries about guidelines are concerned, it is the medical safety promoter who is responsible for accepting them.
7-4 Responses to consultations by subjects
For consultations by subjects about their conditions and courses of treatment, etc., it is required to appoint a person in charge to respond sincerely to a consultation, and the person in charge reports to the attending physician, attending nurse, etc., about the contents, as needed.