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GOOD HOSPITAL PRACTICE

GOOD HOSPITAL PRACTICE

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QM according to DIN EN 15224 / ISO 9001

5.4.04 Individual case analysis of a UE

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1 Purpose and objective

The causes of an adverse event should be determined by professionally qualified case analysts in an unbiased, independent, complete and comprehensible investigation, and the implementation and reporting should be defined. 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 hospitalisation, 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 mistake is realised. 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: 3 May 2002, from 09:30 - 10:30

3.4 Which documents were analysed?

Medical records, operation report, descriptions of the parties involved, expert reports, 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, operating theatre nurse, anaesthetist

3.6 Which department or service was involved in the incident?

All areas or functions that had any conceivable influence on the event should be listed here. Example: Operating theatre, ward, anaesthesia, 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 labelled?
The process illustration 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 works
  • as 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, labelling 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 the operation

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 show 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 the order of operations, 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 trial?

List of all devices and materials used in the process.
Check in detail:
- Have all checks for proper function been carried out?
- 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, organisation
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 colour 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 organisational measures. However, there should not be too many factors here: every organisation must aim to exclude such factors in their influence on the patient.
Example: A hospital is not responsible for a power failure with equipment failure in the operating theatre. However, it should be prepared for this possibility and be able to rely on a backup circuit with a fused 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 operating theatre of general surgery. 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 induction 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, length 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, have state-recognised training. According to the documentation in the personnel file, they were trained. The surgeon performs 250 operations a year independently. The surgical catalogue lists 123 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, holiday period, etc.) have reduced staffing levels.) Deviations (upwards or downwards) should be discussed.
Example: The staff deployment plan provides for four qualified nursing staff, 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, cancellation of interventions, blocking of beds.

3.16 The performance of staff should be reviewed.

When did the team last carry out the analysed process The skills of the team should be related to the requirements of the analysed process.
Example: The nurse from an agency was not familiar with the department's method of marking the operating theatre field. An in-house representative took over the positioning in the operating theatre. A nursing assistant was assigned to the operating theatre. The person was inadvertently assigned in the duty rota 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 did they know their responsibilities, organisation, procedures and practices for safety, handling hazardous materials, emergency equipment and managing 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 instructed? 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 it summarised to 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 anaesthesia not mentioned on the handover protocol.
- Allergies are noted 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 analysed (create matrix)
- Doctors to....
- Carers to....
- Technician to ....
- Pharmacist to....
- Differences in rank....
- Relationship conflicts
Other combinations may result from the examination process. Example: theatre nurse no longer speaks to the senior doctor 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 (haemodynamics, 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 they met? Is there a risk assessment?
Examples:
- In eight operating theatres, the operating tables face the window, in the 9th operating theatre the operating table faces the door. Can a standardised 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 recognisable errors are planned and tested?

Have all employees taken part in the resuscitation course? Is the emergency trolley checked regularly? What does the anaesthetist do in the event of suspected intubation failure?
Example: The emergency power generators are tested regularly. No problems were encountered 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 on the generator 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 favourable to risk identification and control?

Does the management encourage suggestions for change, ideas, improvements and risk awareness? Are employees' concerns (increased risk) taken into account? Has management identified areas of increased risk and acted on employee suggestions 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 organisation 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 management's attitude known and is this clear from their behaviour? 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 analysed 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 turn up because he's stuck in a traffic jam
Each description should be further analysed 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 a recurrence. If a risk reduction is not necessary or possible, this should be explained in detail. A risk reduction should also be proposed for those 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 tested?
- Are there performance indicators that can be used to recognise a positive development?
Corrective actions can be tracked in a table or in a GANTT chart. Responsibility should lie with QM coordination. .

Cause, improvementRisk reduction strategyResponsible personTarget date of realisationTest crite-rium
Page mix-up; OP field to be labelled in futurePermanent markers available on wards. Instruction for operating theatre field marking.Operating theatre managerSept 2002Checking 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 analyse 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 of the Joint Commission 2014

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

7.2 Terms

8 Systems

8.3.2022

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5.4.04 Individual case analysis of a UE

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