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Recommendations by the Quality Task Group
[13] Quality Assurance on the "Clean Side" of a CSSD

How can the work flow arising after automated or manual processing until the time of handing over the sterile supplies be rendered reproducible by an easy means? This question is certainly posed by many of those bearing responsibility in the Central Service Supply Departments (CSSDs) and who, for example, have no special computerised programmes at their disposal. Especially in small hospitals it is important to make provision for cost-effective and relatively easy implementation of validation and associated documentation.

The available LITERATURE on being more carefully perused yields a lot of information which anyone can adapt to the individual circumstances of "his/her" CSSD. This literature includes for example the journals Central Service and aseptika, the brochure "Instrument Processing Done Properly", DIN paperbacks 169, Steriliser Equipment Requirements and 263 Sterilisation of Medical Devices or the recommendations of the Validation Work Group of the German Society for Hospital Hygiene (DGKH). Different FIRMS (e.g. BAG, MMM, etc.) also provide users with interesting and important information.

The points outlined below can be of assistance here so as to make best use of, and allocate, the existing materials, structural and human resources and monitor them on the basis of the actual circumstances. Of paramount importance here is that this "schedule" should be adapted to the conditions prevailing in the different CSSDs.

Inspection, Functional Check, Care, Packaging

Procedural steps

• Inspection/control of the disinfected and cleaned items
• Functional check and care of the disinfected and cleaned items
• Repairs or exchange of defective instruments
• Packing of trays and packaging of individual instruments

Adjuncts and stipulations

• Manufacturer’s product data sheets
• DIN paperbacks 169 and 263 (these should be available as standard publications in the department)
• German Medical Devices Act (MPG)
• Accident Prevention Regulations (UVV)
• Valid infection control and disinfection plan
• The brochure "Instrument Processing Done Properly"
• Packing lists and photo-documentation

Documentation

• Workplace descriptions
• Working instructions
• • for any work conducted by the CSSD itself (e.g. product used to remove extraneous rust)
  • for processing repaired/factory-new instruments
• Statistics and monitoring of repairs
• Packing slips and tray lists

Personnel

• Briefing of personnel
• Personnel training as per DIN 58946-6
• Regular appraisal of the need for training, and retraining if necessary

Sterilisation and Provision

Procedural steps

• Implementation of the daily routine check of sterilisers
• Determination of the sterilisers’ load (e.g. heavy containers below, cf. UVV)
• Selection of a suitable sterilisation programme
• Release of the sterile item
  • after appraisal of the process sequence (temperature, pressure, time) based on the batch documentation
  • after visual inspection of the integrity of packaging and of labelling
  • as applicable, after evaluation of the chemical batch control
• Storage, transport and provision of sterile items as per the currently valid standards

Adjuncts and stipulations

• Operating manual of the manufacturers of sterilisers, sealers etc.
• Appliance Book
• Specifications and information of the instrument manufacturers
• Literature such as the brochure "Instrument Processing Done Properly"
• DIN paperbacks 169 and 263

Documentation

• Recording of the daily routine sterilisier tests (vacuum and Bowie & Dick test)
• Chemical batch control
• Release protocols with operator’s name, device number, batch number and recording of process-relevant parameters
• Recording of all events regarding the appliance in the Appliance Book
• Proof of personnel briefing
• Production statistics

Personnel Requirements

• Persons conducting daily routine tests, loading the steriliser and releasing the sterile items must be briefed and authorised.

Summary

It is to be noted that all procedural steps must be described and documented. Suitable for this purpose are for example workplace descriptions in the case of the individual areas and a QUALITY MANUAL for the entire department. All staff members must have access to this and it must serve as a basis for internal advanced training and continuing education.

The most important factor here is the documentation. This includes, inter alia, also a description of the materials used for maintenance (e.g. oil spray, metal-free brushes) and instructions for implementation of all procedural steps. This is a fixed component of quality assurance within the department. During daily routine operation, provision must be made so that the REPRODUCIBILITY of all processes and procedural steps is ensured. This includes a regular check of all relevant sequences by those responsible for CSSD operations.

Furthermore, proof of PERSONNEL TRAINING must be furnished.

Goal

A further step aimed at quality assurance would be to assign an advisory role to the CSSD management when PURCHASING all items governed by MPG. Introduction of a Product Commission in cooperation with the CSSD management could contribute to this. In this way bad investments arising from the purchase of materials that scarcely, or indeed do not at all, lend themselves to processing in the CSSD would to a large extent be avoided.