5.1 Testing and measurement

The management must set out in procedural instructions how the regularly performed hospital services (diagnostic, therapeutic, nursing, medical-technical and other measures) are checked to ensure that they are actually carried out as specified in the configurations and in the planning for the individual patient. During the inpatient stay, the patient's condition should be checked so closely and reliably that the influence of the treatment on the state of health can be recognized at any time.

Before discharge, a report should be drawn up which also contains a statement as to whether the therapeutic goal has been achieved or not. Corresponding objectifying examination findings must be listed.

Other key activities such as diagnostics, operations, etc. should already be checked during the stay in hospital to see whether the goal has been achieved.

The patient's subjective assessment of the measures should be recorded during the final examination. The patient should be given the opportunity for a later evaluation. The findings about the way in which the patient perceived the service should lead to the adjustment of the service and its provision (patient satisfaction).

The management should define indicators (test data) for quality-relevant measures and for individual treatment patterns that are continuously recorded. They should be presented in quality control charts. Warning and intervention limits should be specified. This also includes regular follow-up examinations of patients. The presentation, including reporting to the management, should be prompt. Further inspections, e.g. in procurement, production, storage, waste disposal, handling of hazardous substances, should be described in inspection instructions.

Testing procedures in the hospital include clinical-chemical, bacteriological-serological and pathological-anatomical laboratory methods, X-ray examinations, cardiological and pulmonological functional diagnostics, endoscopy and many other diagnostic methods.

The test methods should be presented in separate test instructions and contain information on the accuracy, reliability, sensitivity and specificity, repeatability and robustness of the method. The test methods must be used in such a way that they demonstrate the necessary accuracy and reliability. The use of test equipment must be limited to what is necessary.

Measuring devices must be calibrated and adjusted before they are used. Where available, national and international standards should be used.

When calibrating laboratory methods, for example, the procedure used should be specified, including details of the type of device, identification of the device used, location, frequency and method of testing, acceptance criteria and action to be taken if results are unsatisfactory. Records (e.g. QC cards) must be kept.

Procedures shall be established to monitor and statistically control the measurement process. The procedures include testing the skills of the personnel, the measurement procedures themselves and any analytical models or software used for measurement and testing. All measurements and tests must be checked for suitability, validity and reliability. This also includes surveys to determine customer satisfaction (patients, relatives, referring physicians). The use, calibration and maintenance of all test equipment used to provide or assess services should be monitored to provide confidence in decisions or actions based on measurement data. Measurement deviations should be compared with requirements and appropriate action taken if requirements for precision and/or accuracy are not met.

The hospital management selects suitable indicators to demonstrate the stability and continuity of service provision (scorecards). The data should be taken from the hospital's own operations and compared with those of other hospitals (benchmarking).

The management has internal quality audits carried out periodically and according to specific methods to check whether:

• the QM system is implemented and effective
• the regularly performed services are configured
• the configurations are followed in the provision of the service
• the environmental protection targets were achieved

The internal audits are planned and carried out by competent personnel in accordance with procedural instructions. The auditors keep records and report to the management. The management can order further audits, including by external auditors, to ensure that the corrective measures ordered have been successfully implemented.

The auditors should be independent of the activities or areas to be audited. If requested, the auditors shall issue certificates for their activities.