Managers get to grips with laundry process validation

The implementation of the Choice Framework for Local Policy and Procedures, CFPP 01-04 was the dominant theme of this year's conference. Speakers looked at how managers could balance best practice in the light of this document with the commercial reality of diminished budgets.
CFPP 01-04 outlines two key requirements for users and processors of healthcare linen. They must meet the guidelines' Essential Quality Requirement but in doing so they must aim to move to the Best Practice level of service over the life of the document.
John Herbert, laundry and linen services manager for the Royal Devon and Exeter NHS Foundation Trust explained that CFPP 01-04 is divided into four manuals setting out the requirements for the safe decontamination of linen for health and social care. So guidelines detailed over a total of 161 pages, effectively replace the previous standard, HSG95 (18), which consisted of only 12.
He said guidance manuals only provided an overview and pointed out that linen users and linen processors must review the full guidance to identify the action needed to comply with the updated requirements and expectations. Published by the DoH in July last year, CFPP 01-04 amalgamates earlier versions of laundry guidance and replaced HSG(95)18 with immediate effect.
The Choice Framework is open for review on a six-monthly basis as evidence of good operational practice and as developments in technology and techniques advance.
The four manuals cover management and provision (which includes DoH policy on safe linen decontamination and processing); social care (which provides guidance on how to implement linen decontamination in social care settings); specific guidance for linen processors that plan to implement the European standard BS EN 14065 or have already done so and engineering, equipment and validation. This last covers standards and regulatory frame work, the roles of key personnel and design and pre-purchase considerations. It also looked at validating and verifying the disinfection performance of washers, washer-extractors and continuous tunnel washers.
Herbert said that all laundries including small scale operations and local linen processors have been expected to meet the quality requirement since July 2012 after the formal release of the?CFPP 01-04 guidelines. Organisations must have written policies and procedures for the safe operation of all processes and equipment.
All linen processors must meet the quality requirement for the decontamination arrangements for linen used in health and adult social care sectors.
This includes all parts of the guidelines for service delivery, process control, risk analysis, bio-contamination control and overall process validation.
In addition, linen processors that launder infectious linen must adopt post-wash sorting of linen.
Herbert said there are two compliance routes - the NHS route to EQR; and the BS EN 14065 route to EQR and Best Practice. The textile hygiene standard BS EN 14065, which is commonly referred to as "Risk Analysis and
Bio-contamination Control" requires laundries to segregate clean and dirty linen to deal with the risk of
bio-contamination and to ensure there is no chance of recontamination.
He added that providers who attain BS EN 14065 certification immediately meet the quality and best practice requirements of CFPP 01-04. Process validation forms an essential requirement of both routes to best practice and must be carried out for each wash load.
The discussion after this presentation revealed that at present no UK organisation is accredited to BS EN 14065.
Mike Palin, who runs the consultancy Technical Matters, and is on the Textile Services Association's Technical and Standards Committee, is a leading expert on British, European and International standards for laundry processing and machinery and healthcare.
He said that a laundry's first step towards achieving BS EN 14065 certification is to purchase a copy of the standard and to implement its quality management system and specific requirements. This is not a task to be undertaken lightly as it requires a thorough commitment, a great deal of effort and also has a financial cost.
However, those that have achieved it comply with CFPP 01-04 and benefit from a significantly improved business operation. The have found that staff perform better and have a better attitude to the work because they have had much more training, been given more responsibility and feel involved in the whole process.
In the later stages of implementation, or on its completion, the company will wish to be evaluated for certification.

Low temperature validation
Steve Anderton managing director of the Laundry Technology Centre gave a presentation on low temperature washing in relation to CFPP 01-04.
The practice of washing healthcare linen at 65C for 10 minutes or 71C for three minutes to achieve thermal disinfection remains unchanged. NHS trusts require temperature validation inspections and certification; Government guidelines recommend that temperature checks on each laundry machine's disinfection cycle are carried out every six weeks.
In the discussion session, both Anderton and Palin pointed out that although monitoring and verification are important for process validation, there is no one clear industry definition.
Validation for CFPP01-04/BS 14065 should provide Key Process Indicators (KPIs) that have a significant effect on quality and determine what can be monitored in real time to provide immediate (parametric) release of product.
A parametric release system requires validation of the sterilisation process. This requires evidence (data) that all equipment to be used in the overall sterilisation process has been installed properly (installation qualification), that the equipment operates as intended (operational qualification), and, in the most important and complicated step, that the overall process consistently produces a sterile product (performance qualification).
The majority of this test data to support the validation process will be generated in the laundry.
Malcolm Martin of Miele Professional spoke on CFPP 01-04 and OPL design, and how CFPP 01-04 will impact on OPL and single machine installations in the healthcare and social care sectors. Best practice for the disinfection stage requires annual validation, conducted by the validator contractor or machine manufacturer.
He said there is no simple method to verify by inspection or to test the efficacy of the disinfection process on each piece of linen before it is used.
Testing a laundry's washers has several requirements.
The disinfection processes must be validated before use; the process must be monitored during routine use to judge its performance. The calibration of controls and instrumentation must be verified and in addition equipment must undergo a suitable programme of maintenance.
Martin explained that performance qualification is the procedure for obtaining documented evidence that the washer, as commissioned, will produce disinfected linen of the standard required when operated in accordance with the instructions for a particular load type.
Performance qualification tests are performed as part of an initial validation procedure and also as part of any repeat validation procedure and whenever the operator judges that new loading or operating conditions require a further test.
Fresh performance qualification tests may be needed if there are changes to the chemical additives used in disinfection, if the loading system changes or if the laundry has to process a new type of material.
He said the Miele Independent Monitoring System has been installed in hundreds of hospital and social care environments in the UK and has been operating successfully for more than three years.

Linen losses
Murray Simpson, chief executive of Textile Services Association talked about linen loss in NHS and how to prevent this.
TSA became involved in tackling the problems of linen losses over two years ago.
Against the background of the global rise in cotton prices, it set out to make the hospitality sector aware that linen has a cost and that stock theft, fraud or mismanagement affects how TSA members deliver and charge their customers.
Although prices had eased by 2011/12, the pressure on the industry remained, said Simpson, due largely to poor stock management and increase in theft of linen.
The TSA's Linen Lockdown campaign has been very successful in tackling this and is fully backed by the hospitality industry, said Simpson and he thought that the healthcare sector could benefit from the lessons learnt during this campaign.
Linen losses are a big problem for healthcare operators `- around 30,000 pieces a day which work out at an annual total of 250,000 with a cost of £20million.
He acknowledged a report compiled by Ian Hargreaves, SHLSLM national officer that concluded that over 60% of the NHS relied on the private sector for linen, mainly on a hire basis.
As a result linen losses are no longer an agenda item, as the cost is picked up by the contractor. However Simpson said that the cost of lost lines feeds back indirectly to the NHS. Textile costs are rising at an alarming rate, for example the cost of a bed sheet has increased by 38% in the last six months. As a result private contractors will be looking to pass this cost on to the NHS and with unexplained losses also rising (in some Trusts in excess of 20% per year) this will have an overall effect on the cost of linen services.
Simpson said that the healthcare sector needed to develop its own "Linen Lockdown". This might set guidelines on condemning linen; recording "unexplained losses" and ensuring that the clean linen room and the soiled item storage areas were secure.
Simpson highlighted the Sunlight Service Group's campaign to prevent soiled linen from being incinerated - its "Don't Burn It, Bag it" posters urged its health workers to recycle healthcare linen by ensuring that it was returned to the laundry for decontamination .
Rachel Roocroft, the category manager of Government Procurement Services provided the conference with an update on RM1031 Supply, Hire and Delivery of Laundry & Linen Services Framework.
The agreement replaced the earlier NHS Purchasing and Supply Agency (PASA) framework, which had expired on
30 April 2010.
Conforming to NHS and Social Care Requirements under CFPP 01-04, RM1031 is intended to provide a cost-effective and quality controlled outsourced linen service.
It supports the DoH objective of enhancing the safety and quality of services for users and patients.
Customers are guaranteed an up-to-date service from a range of regional and national suppliers, each of which complies with CFPP 01-04.
The framework is divided into four Lots - Wash & Return with 13 suppliers; Linen Hire with 12 suppliers; Hire of CE Marked Reusable Barrier Theatre Textiles, one supplier; and Mop Hire with five suppliers.
Roocroft said that Government Procurement Services is actively
working with customers and suppliers to develop the scope and structure of the new framework.

Patient environment
Liz Jones, head of patient environment at the Department of Health, introduced the delegates to the system for assessing the quality of the patient environment, introduced by the NHS in April this year.
The Patient-Led Assessments of the Care Environment (PLACE), will replace the old Patient Environment Action Team (PEAT) inspections.
PLACE assessments will apply to hospitals, hospices and day treatment centres providing NHS-funded care.
One key feature will be the appointment of Patient Assessors.
These are people whose experience of the hospital is as a user, rather than a provider of services.
Assessors will go into hospitals as part of the assessment teams to judge how the environment supports patients' privacy and dignity, food, cleanliness and general building maintenance.
Although there is no specific reference to laundry provision in Putting Patients First: The NHS England Business Plan for 2013/14 - 2015/16, Jones told the SHLSLM conference that clean linen will remain an important area. A survey conducted for the NHS showed that 98% of patients said that clean linen was very important.
Rob Ridge, deputy head of facilities management at Derby Hospitals NHS Foundation Trust spoke on reducing linen and laundry service costs and improving the patient experience. This came about through the introduction of single-use patient clothing patients to wear when they are discharged. Provision of hospital nightwear forms part of the Trust's fully managed rental linen and laundry contract with Synergy Healthcare.
The Trust's facilities management and medicine division undertook a pilot study of the use of a single-use, two-piece theatre scrub suit as an alternative to discharging patients in hospital rental nightwear.
He told the conference that staff and patients reported that the garments were an improvement on discharging patients in hospital gowns and provided a reasonable alternative to hospital rental linen nightwear.
A survey indicated that up to 50 patients per week could be discharged in hospital rental nightwear.
Since the end of the pilot, the trust has continued to purchase and supply the single-use scrub suits to the pilot wards and discharge lounge.

Significant decrease in reported HAI cases
Martin Kiernan, nurse consultant at Southport and Ormskirk Hospital NHS Trust spoke on the significant decrease in cases of Healthcare Associated Infections (HAIs). In England the number of reported HAI cases fell from 434 in January 2006 to 23 cases in October 2012.
The NHS achieved this 94.7% reduction through better practice, confidence and engagement with staff and patients, particularly on the topic of hygiene. The British Medical Journal had highlighted the significance of hand hygiene in its 2012 study.
The rates of MRSA/CDI related deaths have fallen by 30% per year for the past three years, so the national media no longer sees this as an issue.
However, more challenges lay ahead, said Kiernan. These included multi-drug resistant organisms and device-related infections. Linen services would have a part to play in infection prevention.
Robust systems and processes will minimise risks said Kiernan, adding that monitoring is particularly important and infection prevention control teams will need to be vigilant to the future possibility of textile involvement in HCAI.
A project to buy laundry services for London hospitals was outlined by Silvana Juliano, the senior category manager for the London Procurement Partnership (LPP) estates and facilities workstream, based at Guys and St Thomas' NHS Foundation. LPP is a membership organisation, founded and funded by NHS organisations.
It supports the NHS to make the most of its purchasing power to maximise investment in patient care.
The project started in March 2012 to identify Trust requirements for linen and laundry and to date 12 Trusts have agreed to participate. The annual spend based on Trust data is around £8.5million per annum. Tenders were returned in December 2012 with awards made directly with suppliers.
The conference organisers reported that feedback on the Stratford venue had been positive. The conference will return there but next year's event will be in Buxton which was also well received at the society's last visit.