5.4.04 Individual case analysis of a UE

1 Purpose and objective

The causes of an adverse event should be determined in an unbiased, independent, complete and reproducible investigation. Corrective and improvement measures should be proposed as a result of the investigation.

2 Scope of application

Unwanted events, special incidents where the management sees the need for an in-depth analysis. The case analysis is formally commissioned.

3 Description

3.1 Description of the event

Short name for identification
Example: Side confusion in hernia closure

3.2 Description of the event

Brief summary of what happened, including the outcome of treatment (prolonged hospitalization, loss of function, disability, death).
Example: a thirty-year-old man is admitted for groin surgery on the left. The operation is started on the right side until the error is noticed. The right side was sutured up again and the hernia was closed on the left. The further healing process was unremarkable.

3.3 Information on timing

Date and time, possibly time period
Example: May 3, 2002, from 09:30 - 10:30

3.4 Which documents were evaluated?

Medical records, surgical report, descriptions of the parties involved, expert opinions, etc.

3.5 Who was involved in the FMEA?

List of members of the analysis group, without names, only with position and title.
Example: senior physician in general surgery, ward nurse, admission nurse, OR nurse, anesthesiologist

3.6 Which department or service was involved in the incident?

All areas or functions that had an influence on the event in any conceivable way should be listed here. Example: OR, ward, anesthesia, surgeon, admission service

3.7 What are the individual steps of the process that led to the event?

Is there a flowchart with the individual steps of the process, in which the key steps are also marked?
The process diagram should be used to check whether all points have been taken into account.
If no flow chart is available, one must be created.
Create a flowchart of the process

• how this is planned
• how it usually takes place
• how it happened when the event occurred

Identify the points in the process flow from which disruptions to the proper process flow may have originated and contributed to the event.

• Flowchart of the process with improvements

Example: Admission procedure, diagnosis of the diseased side, marking of the operating field by the surgeon, entry in the operating plan, note on the information record, note on the premedication visit, positioning by the nurse, preparation of the operating field, time-out before the start of surgery

3.8 Ishikawa diagram

An Ishikawa diagram should be drawn. The result is the adverse event. The "bones" here can be the four "P's": Patient - Procedure - Product - Personnel
Example Appendix 1 3.9 What human factors were involved in the incident? List the people involved, describe their tasks and prove whether they were carried out, reasons why they were not.
The employees are to be interviewed individually with the following questions:
- Have you been instructed correctly?
- Did you know exactly what to do?
- Did you know what work result is required of you?
- Do you have the necessary knowledge?
- Did you feel capable of the task?
- Have you mastered all the moves?
- Are you familiar with the method?
- Are you taking enough care?
- Were you able to concentrate enough?
- Have you always been attentive?
Example: Change in surgeon, change in order of surgery, missing surgical field markings. Stress, lack of concentration, excessive time pressure

3.10 To what extent did devices (medical devices) contribute to the outcome of the process?

List of all devices and materials used in the process.
Check in detail:
- Have all tests been carried out to ensure proper function?
- Were the devices available?
- Have the maintenance and servicing measures been carried out?
- How often are the devices used?
- Were the alarms, display panels and indicator lights set correctly and did they work?
- Were operating errors made?
- Were the operating instructions understandable?
- Were the users instructed?
- Were material properties responsible for the outcome?
- Were the devices suitable for the purpose?
If all the details are correct with regard to
- Machines, lighting, devices, ventilation, tools, noise level, material, temperature, regulations, order, instructions, cleanliness, drawings, protective devices, working papers, transport routes, measuring equipment, means of transport, workplace, organization
Examples: Device failure due to lack of maintenance. Incorrectly set output on a pump. Pump was scheduled for repair but was placed with the serviced pumps. User made a mistake during operation. No infusion pump to be found in the area.

3.11 Influencing factors

List all the factors that need to work in order to achieve the desired result. Example: The surgical field was marked with a pen, but the color was washed off during shaving.
Are there other, but uncontrollable factors that contributed to the outcome?
Uncontrollable factors are those that cannot be controlled by organizational measures. However, there should not be too many factors here: every organization must aim to exclude such factors in their influence on the patient.
Example: A hospital is not responsible for a power failure resulting in equipment failure in the operating theater. However, it should be prepared for this possibility and be able to rely on a backup circuit with a secure power supply.

3.12 Which other areas or services are affected

List the other areas where a similar event could occur. What measures have been taken or should be taken there to prevent a similar event?
Example: Side mix-ups are not just a problem in the general surgery operating room. The same preventive measures should be proactively introduced in the emergency department, urology department, etc.

3.13 Were the staff appropriately qualified and sufficiently competent for their tasks?

All staff in the area should be included in the investigation, not just those who were directly involved in the incident. Do not overlook medical and assistant staff!
Determine whether staff have been formally trained to perform the specific tasks correctly. Was the training appropriate?
Was the staff instructed on the devices? Was this documented? Was it checked whether the personnel were sufficiently qualified for the tasks? Were personnel involved who were not familiar with the processes or equipment? Were temporary staff involved who were inadequately instructed?
Were employees new to the area and still lacking the necessary experience? Were the procedures implemented in the department known to everyone?
The professional background, the duration of work in the field, the volume of work in general (how many operations) and specific (how many operations of the same type?), training, training experience, usual activity, duration of time already worked, etc. should be listed for each employee.
Example: The surgeon was a specialist in surgery and all those involved, with the exception of the positioning nurse, had state-recognized training. According to the documentation in the personnel file, they were trained. The surgeon performs 250 operations a year independently. The surgical catalog lists 123 inguinal hernia operations.

3.14 Was the deployment of personnel within the planned range at the time of the incident?

Did the personnel deployed correspond to the workload? Check whether special conditions (weekend duty, previous on-call duty, vacation time, etc.) reduced the staffing level.) Deviations (upwards or downwards) should be discussed.
Example: The staff deployment plan provides for four registered nurses, one nursing assistant and one student for 26 patients. Four registered nurses, two nursing assistants and one student were currently present. One registered nurse took part in an in-house meeting.

3.15 What reactions are planned to compensate for any staff shortages?

Check the personnel deployment planning and the measures for replacement procurement.
Example: Deployment through staff leasing, pool staff, temporary staff on call, overtime regulations, temporary staff from other areas, removal of interventions, blocking of beds.

3.16 The performance of staff should be reviewed.

When did the team last perform the analyzed process The team's skills should be related to the requirements of the analyzed process.
Example: the nurse from an agency was not familiar with the department's method of marking the operating field. An in-house representative took over the positioning in the OR. A nursing assistant was assigned to the OR. The person was inadvertently assigned in the duty roster and took over tasks on her own initiative.

3.17 How can training be improved in individual tasks?

Were all employees briefed on their duties and aware of their responsibilities, organization, procedures and practices for safety, handling of hazardous materials, emergency equipment and control of complications? Are all procedures up to date, reviewed and approved?
Are they understandable? Are they based on verifiable findings? Were they available? Have procedures been changed without adequate staff training?
Was the procedure new and the personnel adequately trained? Were alternating personnel in the area of operation new? Had they been instructed? Is this documented?
Example: A new infusion pump was introduced. No formal instruction had been given. The representative had left a business card and written instructions. Most employees had read the new operating instructions, but one temporary employee had not been made aware of the change. No entries had been made in the equipment book.

3.18 Was the information that was needed available at all times?

Were the findings from the medical history, physical examination and laboratory results, x-rays and other findings available and known to the persons involved in the treatment? Was the patient correctly identified? Were the notes in the medical record complete, legible and understandable? Was there a summary of the essentials? Is there any superfluous or redundant information in the records?
With automatic documentation: are transmission errors excluded?
Examples:
- Operating instructions for the children's Ambu bag cannot be found.
- Infusor speed expressed in ml/min rather than switch level.
- Risk of falling after anesthesia not mentioned on the handover protocol.
- Allergies are listed on the cover of the medical record, where they are usually highlighted.

3.19 Was the communication between the parties involved appropriate?

The verbal and written exchange of information between employees and the reason why this did not take place should be investigated (create matrix)
- Doctors to....
- Carers to....
- Technician to ....
- Pharmacist to....
- Differences in rank....
- Relationship conflicts
Other combinations may result from the examination process. Example: Operating room nurse no longer speaks to the senior physician since he ended his relationship with her.
Was the most important information passed on in a timely manner? Were there any misunderstandings due to language barriers, abbreviations, terminology, etc.? Was information lost during the handover from one shift to the next?
Are there requirements for the information that must be available before an intervention is carried out? Is there an addressee from whom missing information can be obtained?
What information is transmitted when a patient is transferred from one area to another (hemodynamics, intervention information, further treatment, necessary monitoring)?

3.20 Was the environment appropriate for the process performed?

The environment to or from which a patient was brought should be examined. Was the room large enough? Safe, respectful of privacy, accessible? Was it too hot, too cold, too humid, too dry? Light? Noisy? Dusty? Are there specific requirements for the working environment? And were these met? Is there a risk assessment?
Examples:
- In eight operating theaters, the operating tables face the window, in the 9th operating theater the operating table faces the door. Can a uniform alignment help prevent side confusion?
- A patient climbs up the downpipe of the gutter with suicidal intent. The ascent can be prevented by steel pins pointing downwards.

3.21 What responses to emergency situations and recognizable errors are planned and tested?

Have all employees taken part in the resuscitation course? Is the emergency trolley checked regularly? What does the anesthetist do in the event of suspected false intubation?
Example: The emergency power generators are tested regularly. There were no problems during the test runs. Three weeks after the last test, an incident occurs. A generator fails after 5540 operating hours with a guaranteed service life of over 10,000 hours. The test shows that only occasionally switching the unit on for short periods wears it out more quickly than the tried and tested continuous operation.

3.22 To what extent is the general attitude of employees favorable to risk identification and control?

Does the management encourage suggestions for change, suggestions, improvements and risk awareness? Are employees' concerns (increased risk) taken into account? Has management identified areas of increased risk and acted on suggestions from staff to mitigate risks? Were suggestions for improvement implemented promptly?
Example: Members of management, including the managing director, take part in meetings to discuss undesirable events. Confidential acceptance of reports is offered. There is a permanently manned telephone line to which risks can be reported. The reports are read and responded to.

3.23 What barriers prevent the communication of potential risk factors?

What is the organization doing to break down such barriers? If there are no barriers - how has this been achieved and how do we know that this is the case?
Example: Nursing staff fear a deterioration in the working atmosphere with the medical service if they pass on information directly to their nursing manager as prescribed.

3.24 Is it clear that the prevention of adverse events is a high priority?

Is the attitude of the management known and is this clear from their behavior? Collect examples!
Example: Management responds immediately to a serious adverse event. Those affected, including the patients, are informed by an independent person.

3.25 What can be done about influencing factors that the hospital can only control to a limited extent?

The entire system through which the patient has passed should be examined for uncontrollable factors.
Examples:
- Power failure due to thunderstorm
- Resuscitation team stands in front of a locked door
- Patient concealed drug abuse
- Doctor doesn't come because he's stuck in a traffic jam
Each description should be further analyzed to determine whether there are ways to prevent such an event. Or whether the procedure can be changed in such a way that the influencing factor can be eliminated.
A literature search for comparable situations may be necessary. Literature used for the analysis should be cited. Recommendations should be based on "good practice".

3.26 Proposal of corrective measures

At the end of a root cause analysis, a recommendation is made as to what should be done to prevent recurrence. If a risk reduction is not necessary or possible, this should be explained in detail. A risk reduction should also be proposed for areas in which no comparable adverse event has occurred to date.
The following points should be clarified:
- What is the strategy for reducing the risk?
- Who is responsible for implementing the measure?
- By when should the measure be implemented?
- How can the effectiveness of the measure be checked?
- Are there performance indicators that show a positive development?
Corrective actions can be tracked in a table or in a GANTT chart. Responsibility should lie with QM coordination. .

Cause, improvement	Risk reduction strategy	Responsible person	Target date of implementation	Test crite-rium
Page mix-up; OP field to be labeled in future	Permanent markers available on wards. Instruction for OR field marking.	OP Manager	Sept 2002	Checking of the marking by the position keeper on entry. Unmarked patients were rejected.

Cause, improvement:
Brief description of the cause to be eliminated and the desired improvement
Risk reduction strategy:
Measures planned to reduce the risk
Responsible person:
Person who is responsible for ensuring that the measures are implemented or who informs the management about the status of the project in the event of obstacles.
Target date of implementation
Milestones by which measures are to be implemented.
Test criterion:
characteristic that can be used to check successful implementation. This is usually a qualitative characteristic that needs to be checked. If there are quantitative characteristics, these are best recorded in a quality control chart and a target value is set. The method of data collection should be defined in an inspection procedure.

3.27 Time required

Several hours to days for a team of case analysts

4 Documentation

Flow charts, Ishikawa diagram, table with corrective measures, literature, report

5 Responsibilities

The Executive Board commissions the QM Coordination or an independent expert or commission to analyze the case

6 Notes and comments

7 Applicable documents

7.1 Literature, regulations

Root Cause Analysis of the JCAHCO 2002, update according to a submission by the Joint Commission 2014

Aktionsbündnis Patientensicherheit: Recommendation for the implementation and execution of case analyses

7.2 Terms

8 Systems

8.3.2022