2.3.01 Core process

1 Purpose and objective

The core process of the hospital is medical treatment. To ensure that medical services are provided under controlled conditions, all services must be identified and planned.

Other core processes need to be identified in other business areas such as medical research or education and training:

• In medical research, the core process is the clinical or non-clinical examination.
• In education and training, the core process is the teaching unit.

2 Scope of application

Identification, planning and presentation of hospital treatment in the phases of admission, diagnostics, preoperative preparation, intervention, postoperative treatment and discharge, including the activities for their maintenance and environmental conditions, to ensure that medical services are provided under controlled conditions.

3 The core process

3.1 General information

Controlled conditions require
- Procedural instructions for the implementation of all individual steps in the provision of services
- the use of suitable facilities (rooms, equipment) and a suitable working environment
- Compliance with the relevant standards and regulations
- the monitoring and control of process parameters and product characteristics
- Clear criteria for carrying out the work (indication and contraindication)
- the appropriate maintenance of equipment and rooms
- Knowledge of the time required: no process can suddenly run faster due to external requirements (such as an emergency, delivery date, production backlog) without appropriate measures having been taken beforehand.
For process results whose fulfillment of the quality requirements cannot be verified on the result itself, the work must be carried out by qualified personnel and the production conditions must be constantly monitored. Records of this must be kept.
Test instructions used to measure the stability of the process (the degree of process control) must themselves be validated. Requirements for the method documentation can be found in the SOP.

3.2 Structure of the core process in the hospital

Treatment in hospital can be divided into phases. The distinction between

Not all phases are always equally important. However, they are part of every treatment to a certain extent. For a treatment pattern, the phases can be processed separately because they hardly differ until the actual core treatment procedure itself (operative phase).

3.3 Modular structure

Independent procedures are used in the treatment phases:

• During admission, administrative data, the patient's medical history, physical examination findings and information on the social background are collected. The medical problem is identified.
• In the diagnostic phase, further diagnostic tests are carried out, the patient's list of problems is drawn up, the treatment options are weighed up and a decision is made. The data material and the selection decision are reviewed.
• In the preoperative phase, the patient is prepared for the treatment.
• The actual treatment is carried out in the surgical phase. "Operative" is generalized here: every intervention is referred to as "operative".
• In the postoperative phase, the procedures required for treatment after the intervention are listed.
• During the discharge phase, the findings and treatment reports are compiled. The result of the treatment is determined and the physical findings are noted. The course of treatment is formally approved. A decision is made on further care.

Recommendations are made for the post-inpatient care phase. If necessary, their course will be coordinated with the organizations providing further treatment.

3.4 Treatment patterns

For many treatment occasions, a combination of individual procedures is fixed, which can be applied in principle but modified for individual cases (treatment pattern).

The treatment patterns are configured from individual procedures as required.

3.5 Control depth

The processes must be managed according to the requirements placed on them. The following influencing factors should be taken into account: Employee qualification level, employee fluctuation, series size, safety relevance, complexity of the Q requirements for the product, hazardousness, degree of control, degree of novelty, degree of automation, repeatability, process sensitivity, number of process-influencing parameters, approval requirement, previous manufacturing costs, processing costs, added value, external requirements

3.6 Individual problems

All treatment steps must be defined, planned and carried out under controlled conditions. To this end, the following must be defined:
- Suitability of resources, facilities, working conditions
- Proof of the degree of process control (e.g. control charts for laboratory determinations)
- Detailed criteria for the execution of work in written instructions, comparison samples, images, standards
- Testing, approval of processes and facilities
- Monitoring of process parameters and product characteristics such as time requirements, travel and waiting times, climatic conditions such as temperature, air pressure, humidity, complication rates, etc.)
- Planning and carrying out necessary maintenance work to maintain process capability (e.g. stop device, carry out maintenance, recalibrate, continue work)
- Restricting the execution of processes to qualified employees or under their supervision if no automatic check is possible
- Use of automatic control technology (switches off automatically when the intervention limit is reached)
- Requirements for the qualification of process sequences must be specified (e.g. for laboratory analysis: accuracy, sensitivity, repeatability, etc.)
- Control of the boundary conditions through appropriate equipment (e.g. vibration-free weighing table)
- Mastery of the properties of the materials used (water, compressed air, electrical energy, chemicals)
- Creation of suitable working conditions, in particular lighting conditions, cleanliness, room temperature, noise, work clothing, tools, work instructions, production equipment, assembly equipment, cleanliness, appropriate workplace design
- Process control must be determined repeatedly, e.g. after work breaks, changeover of systems, etc.

4 Documentation

Flow chart for hospital treatment
List of medical departments that provide medical treatments as core services
List of medical departments that support the core services.
Qualification documents for personnel, processes or equipment
Measurement results of boundary conditions
Test results e.g. of the control charts
Evidence of compliance with setting parameters by checking the setting elements and display devices
Agreements on changes in the procedures for testing, process control, etc.
Release of the production documents before use

5 Resources

6 Notes and comments

Many prerequisites for mastering a manufacturing process already arise during product planning or must be integrated into the creation process itself. Later, it is only possible to check whether production is stable, i.e. within the fluctuation range that is considered "typical" for the process.
This is why determining the degree of control is of great importance in laboratory analysis, for example, because it also determines how and to what extent the data can be interpreted. "Controlled" then always means that the process is "stable", i.e. fluctuates to the known extent.

7 Responsibilities

Responsibilities must be defined according to the processes.

8 Applicable documents

8.1 Literature

8.1 Operational planning and control DIN EN ISO 9001:2015 and DIN EN 15224:2017
Section 8.5.1 and passim DIN EN ISO 9001:2015

8.2 Terms

The core service is the hospital's service for which the hospital can generate revenue directly or indirectly.

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