Providing assurances on process validation

Process validation came under the spotlight at the Society of Hospital Linen Service and Laundry Managers (SHLSLM) 2009 conference in Blackpool. Delegates heard that adopting a commonly accepted scheme for laundry and linen care within the National Health Service is not straightforward.

Last year, SHLSLM published its long-awaited Best Practice Guide for Linen Services, which sought to establish minimum standards for the purchase, processing and storage of linen used within the NHS and healthcare sector. Ian Hargreaves, of SHLSLM, explained that a recent search of the National Patient Safety Agency (NPSA) website site produced 55 results for general cleaning standards and a further 13 for food, nutrition and hygiene but there were none at all for linen or laundry.

David Griffiths of Lilliput Laundry Services expanded on this point in his presentation on the future of garment provision in the NHS. He contrasted the elaborate uniform regime that existed within the food processing industry with the conflicting signals sent out by the Department of Health.

Laundry customers in “high risk” areas like healthcare, food processing and pharmaceuticals are also looking for warranties and reassurances regarding hygiene standards as well as requiring textiles that enhance the image of both staff and premises.

He predicted that there would be an increase in demand for products and services that not only meet the highest specifications but are also accompanied by confirmation of their environmental credentials and of their compliance with varying regulations.

The SHLSLM Best Practice Guide for Linen Services is intended to serve as a basis for developing specifications for a contract or service level agreement. It provides a standard against which services can be benchmarked and a framework for auditing.

June Lancaster of the Institute of Healthcare Management, told the audience that an audit programme is an essential part of the required assurance for infection control. She explained that the Care Quality Commission (CQC) has taken responsibility for regulating health and adult social care with effect from April 2009. It combines the functions of three previous bodies, the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission.

The CQC operates under a legislative framework that was outlined last August by NHS chief executive David Nicholson and gives the commission a wide range of enforcement powers.

These include powers to inspect and investigate, to issue statutory warning notices and financial penalties, and, in the most serious cases, to prosecute or suspend or cancel registration. Lancaster explained that the CQC will continue to monitor compliance against the MRSA (methicillin-resistant Staphylococcus aureus) standard, the C. difficile target and the NHS Hygiene Code and will have additional powers to take prompt action where patients are at risk.

She explained that an audit programme is an essential part of the required assurance framework for infection control.

Under the Hygiene Code’s 11 mandatory duties, trusts are required “to provide and maintain a clean and appropriate environment for healthcare”. As part of the criteria for assessing core standards for Primary Care Trusts (PCT), the code says that “with a view to minimising the risk of healthcare associated infections, trusts must make sure that the provision of linen and laundry supplies reflects Health Service Guidance HSG(95)18, Hospital Laundry Arrangements for Used and Infected Linen.” In addition, the trusts must make sure that clothing worn by staff when carrying out their duties is clean and fit for purpose.

Because the changes only took place on 1 April this year, it is not yet possible to say how the revised Code and enforcement will be implemented, she added. Authorities are still waiting to hear how the CQC plans to carry out inspections. An inspection will include observational visits to wards and departments and interviews with staff at all levels.

Lancaster detailed the kind information an inspector might require as evidence of compliance with the linen and laundry criteria set out by the Hygiene Code. This could include job descriptions, records and details of training provided; clear policies detailing each part of the linen cycle; examples of quality control and independent verification and examples of testing to validate cleanliness of the product in conjunction with infection control.

Ian Hargreaves acknowledged that with regard to infection control, the SHLSLM Best Practice Guide says that all linen must be laundered in accordance with the latest guidance and legislation, including HSG(95)18, to ensure that it is clean, disinfected and fit for purpose.

He stressed that the individual purchasing trusts are responsible for carrying out due diligence tests and inspections to ensure that their suppliers meet and maintain compliant processing standards in accordance with the service specification.

He pointed out that without due diligence tests and inspections, it would be impossible to provide evidence to satisfy any third party audit. The linen services provider should have a formal quality control system such as ISO9001 and/or EN14065 Bio-Contamination in Laundering, or an acceptable alternative.

Minimum standards and procedures for the handling and disinfection of linen are set out in HSG(95)18. Infection control committees should be aware of these practices and be able to endorse or upgrade them before implementation. The HSG(95)18 guidelines are being rewritten as part of a much greater revision of health service standards. With this in mind, and given the advances in chemistry and technology, the Textile Services Association (TSA) has judged it is time to revise its original specification for healthcare laundry to reflect the current requirements of the industry.

TSA will be publishing its manual on the implementation of BS/EN14065 later this year and making it available to members. The author, Mike Palin of the consultancy Technical Matters, explained that the manual would adopt a simplified version of process validation, using Installation Qualifications (IQ) and Operational Qualifications (OQ) with emphasis on Performance Qualifications (PQ).

Two key factors for Quality Assurance (QA) are process validation and process monitoring.

Validation requires documented evidence that provides assurance that a specific process will consistently produce a product to meet pre-determined specifications and quality attributes.

Palin contrasted the manual’s subject BS/EN14065 with HTM01-04, a series of documents that looked at decontamination procedures across NHS services. Laundry processing is seen as part of the wider National Decontamination Programme.

While HTM01-04 provides a management structure and some elements of validation for washing and for monitoring of washing, as a system it fell down on the identification of all control points by hazard/risk analysis. It fails to consider recontamination and is weak on validation techniques and on monitoring essential variables.

However, Palin says that the standard BS/EN14065 is very strong on hazard and risk assessment and monitoring key process variables (for example, temperature, time, load weight, dips and chemical additions).

It is also strong on providing a management structure and a quality system aligned to the ISO9001 standard.

Its weakness is perhaps on validation as it neither defines validation nor advises on how it should be carried out, said Palin. The TSA’s forthcoming manual will seek to address this.

Greg Park, general manager of Salisbury Linen Services, stressed the need for key performance indicators, or KPIs, as a means of monitoring the provision of linen and laundry services.

Speaking about the changing profile of linen usage, he explained that monitoring KPIs will provide an indication of how well the laundry and linen service is performing.

Regular performance reviews are essential to determine if a particular service provider is not performing well. He said the laundry facility for Salisbury Linen Services – operating from its own premises within Salisbury District Hospital – has the capacity to efficiently process 300,000 items per week.

Salisbury – which is currently working towards Environmental Management System ISO14000 and EN14065 Risk Assessment Bio-contamination Control (RABC) – is an approved supplier on the Purchasing and Supply Agency’s (PASA’s) new national framework agreement for laundry and linen services. 

It serves NHS customers in the London, south central, south east and south west regions under the agreement.

Park explained that NHS Trusts that are re-tendering for laundry and linen services are required by PASA to evaluate the most appropriate supplier from the framework.

As Park pointed out, because PASA does not provide “buyer information” to trusts, this left some degree of contract variation.

It was important that the service provider demonstrated that it was fully compliant with the existing guidelines and Park asked whether it was unfair to penalise those providers where there was evidence of poor performance.

In his address entitled “The Way Ahead”, laundry adviser Alistair Campbell outlined the proposed developments of small self-contained laundries and OPLs for community hospitals in Northern Ireland.

The Northern Ireland Health and Social Services Estates Agency (Health Estates) is finalising a regional strategy for laundry and linen services. The strategy has to take account of factors such as changing technologies for laundering materials and the development of new textiles. It must also consider contingency plans, the ability of the private sector to provide a quality service; existing facilities; opportunities provided by planned hospital developments and the economies of scale provided by large centralised operations versus the advantages of a local service.

The proposed self-contained laundries could be on premise laundries or even ward launderettes. They should be designed to be less capital intensive and to reduce maintenance costs. They should have the same level of production in a smaller footprint,

Pol Dewaele, business manager for Primus Laundry Systems spoke about the OPL opportunities within the UK healthcare sector and about the barrier washers his company has developed. Primus barrier washers physically separate the soiled and clean sides of the laundry rooms, and conform to Risk Analysis and Biocontamination Control (RABC) systems.

Celia Thornley of Skillfast-UK, the Sector Skills Council for Fashion & Textiles, gave her views on training and staff development and explained the assistance the government can provide on skills training within the laundry industry.

Textile care remains a priority sector for Skillfast-UK and it will continue with the development of standards in the areas of batch washing, solvent handling and solvent emissions for drycleaning.

Dave Godson, national officer for Unison health group, illustrated the importance of partnerships and working together.