By John Scherberger, FAHE
Before beginning this article, an explanation about EvSOP© is in order. When the Environmental Services Optimization Playbook program was in its infancy, a working abbreviation for the program originated, so ESOP became the word of the day. As with many things in life, abbreviations are either quickly understood or quickly misunderstood. And so, it was with ESOP. Some confused it with an Employee Stock Ownership Plan. Others thought of a volunteer tax assistance program in Ohio. Still, others thought of it as an Employee Stock Option Plan association. Those things were not what the founders of the Environmental Services Optimization Playbook program envisioned. So, in keeping with how healthcare Environmental Services departments abbreviate their departments, the program is henceforth using EvSOP© as the official Environmental Services Optimization Playbook program acronym. The "v" will be silent, so no pronunciation changes are needed.
Now, to answer a question that might come to mind: "What do abbreviations and acronyms have to do with strategies for enhanced cleaning and disinfection in healthcare textiles?” one would rightfully ask. The answer is that often a program or company is only known by its acronym. TJC is The Joint Commission; CMS is the Centers for Medicare and Medicaid Services, and the CDC is the Centers for Disease Control and Prevention. How many know that IBM was initially known as Computing-Tabulating-Recording Company? The list is endless.
What does all that have to do with strategies for enhanced cleaning and disinfection in healthcare textiles? When ensuring that soiled, dirty and contaminated healthcare textiles (HCTs) are processed in a manner that ensures hygienic products result and are delivered, accreditations or certifications from associations and membership organizations are essential. What do HLAC, TRSA, AS/NZ Standard, Hohenstein RAL Quality Certification – Robert Koch Institute, and UK DOH HTM 01-04 mean? What are the differences? What standards or certifications apply to U.S. laundries that process HCTs, and should healthcare laundry contractors be accredited or certified? What does “hygienically clean” mean for HCTs?
To say that COVID-19 has stressed everyone would be a safe comment to make. Not only has the healthcare industry been turned on its ear, but the healthcare laundry and ancillary companies, as well. Every sector has been negatively affected financially and psychologically. Fears and worries of contagion and job loss are common to all. There were, and still are, questions about transmission modes and what's the best way to break the COVID-19 chain of infection.
Well, there is good news. The SARS-CoV-2 virion, which causes COVID-19, is easily destroyed with soap and water or alcohol. The virion is composed of three identifiable components: protein (spike glycoprotein, membrane protein, emerging membrane protein), RNA genome, and a lipid-protein envelope. The three parts of SARS-COV-2 are similar to other virions. What this means is that the standard laundering methods that have kept HCTs hygienically clean and appropriate for all but the most immunocompromised patients continue to be effective in producing hygienic products.
2 colonies per 10 cm2 = 20 CFU / dm2
Requirements for the low germ content of clean laundry
Areas in which the clean laundry
is to be used Microbiological requirements for the
washing process and to the clean laundry
1. areas with particularly high requirements in terms of low germ counts; e.g. surgical units The laundry must be sterile. It should therefore be sterilized in appropriate packaging with steam.
Regular checks are necessary (cf.
Annex to paragraph 7-1 of the Directive); see Section 4 Control tests.
2. other medical areas The laundry must be low in germs. If samples of laundry are copied onto culture medium, nine out of ten samples should not have more than two colonies per 10 cm2 after incubation (see 4). The Laundry has to be packed in an appropriate way in order to avoid recontamination.
2 colonies per 10 cm2 = 20 CFU / dm2
Too often, healthcare professionals and members of the general public limit the "laundering process" to two steps: washing and drying. Healthcare laundering operation strategies include what, to many observers, may appear to be an overwhelming number of levels. Measures include collecting soiled HCTs from the healthcare facility, functional separation of the trucks holding the soiled HCTs, to delivery at the laundry plant, item separation (dirty sort), cart washings, internal transfer of soiled HCTs to the washers, transfer from the washing machines to dryers and flatwork ironers, folding, stacking, loading, inventory, loading of trucks, and transportation to the customer. The steps listed, of course, are a simplified version of steps in the laundering process.
In addressing HCTs and enhanced cleaning and disinfection of those textiles, laundry operations include many strategies and processes in the title of this article. Those strategies include others required by accreditations, certifications, and compliance to industry best management practices and procedures of both government and non-government associations, businesses and agencies.
Laundries that have taken steps to be accredited and certified are required to use EPA-registered hospital-grade disinfectants when cleaning and disinfecting their facilities. They use the same disinfectants for laundry carts, conveyor belts and chutes, table, and trucks to transport HCT to their customers. The current processes in place for decades have resulted in very few HCT related infections. Many laundries are implementing new procedures not required by accrediting or certifying organizations or regulatory authorities having jurisdiction (AHJ) over them to assure further that HCTs produced are and remain hygienically clean.
One of the most recent strategies is voluntary microbial testing of HCTs. As there are no nationally accepted testing standards, laundries are free to choose what microbial testing they contract for and the laboratories they decide to use. And because the standards that exist today to deem laundry “hygienically clean” (2 colonies per 10 cm2 = 20 CFU / dm2 or less), hospitals are receiving information that may or may not be reflecting which microorganisms should concern them.
Additionally, no answer has been provided by any AHJ regarding seasonal differences in mold, pollen, fungi, or spores that may increase or decrease and have the potential to affect large numbers of patients.
Is it too suggestive to say that microbial testing is a shot in the dark, hoping to identify what may potentially harm patients?
Lynne Sehulster, PhD, in a research paper, "Healthcare Laundry and Textiles in the United States: Review and Commentary on Contemporary Infection Prevention Issues," published in June 2015 (Infect Control Hosp Epidemiol, available on CJO 2015 doi:10.1017/ice.2015.135) wrote: "The Centers for Disease Control and Prevention has not recommended routine microbial testing of porous surfaces or of HCTs for infection control purposes. Currently, there is no public health consensus regarding a microbial benchmark to define hygienically clean for textiles. Most importantly, given the historical record for patient safety and extremely infrequent episodes of infection attributed to clean HCTs, the need to establish a certification program based on microbiological testing does not appear to be supported by epidemiologic data."
She continues, "The benchmark set for clean HCTs testing does not appear to be linked to patient outcomes, nor is there any indication from the certification program literature that the benchmark is statistically valid (i.e., within 90 percent to 99 percent confidence intervals)."
Microbial testing of textiles that have completed hygienic laundering processes is not required nor endorsed by the CDC. But that does not mean microbial testing of HCTs is a wrong thing to do. When thinking about HCT microbial testing, more discussion, and deliberation than "It sounds good, let's do it" must be addressed. Being the professionals that they are, infection preventionists (IPs) recognize that the microbial targets are always moving, changing, transforming and adapting.
Over the past few years, many IPs in U.S. and Canadian hospitals have been requesting microbial testing of their contractor provided HCTs. The problem is that there are no statistically valid reasons (other than data collection) to do so. Neither they nor their HCT contractor has definitive answers about which micro biologicals are harmful and in what quantities to their general patient population.
HCT microbial testing does not provide sufficient scientific supported data to ensure proper confidence intervals. IPs typically rely upon contractors to offer the intervals, and laundry contractors rarely have the training or underlying knowledge to establish such. Forward-thinking laundry processors have taken the initiative to contract with the aforementioned accreditation/certification organizations to ensure consistency in both process and outcome. Compounding the lack of confidence levels is the question of realistic remediation plans for themselves and their contractors that need addressing. All microbial testing currently being conducted provides a retroactive look at colony-forming units (CFUs) of HCTs previously supplied to hospitals. What plans are in place in both the laundry contractor and hospital microbial testing revels that CFUs were exceeded on HCTs delivered many days or weeks previously?
What about additional microbiological testing of supply water, discharged water, employee hands, employee PPE, facility air, and both surfaces that encounter clean HCTs and surfaces that don't come into HCT contact? What about surgical assembly pack rooms?
All these questions are worthy of consideration and answering.
Without U.S. regulatory- and scientifically-based CFU counts recognized as appropriate for most hospital patients, excluding immunocompromized patients and patients needing sterile HCTs, IPs are setting themselves up to justify the CFU levels agreed upon with their laundry contractor. Although ≤20 CFUs has been accepted throughout European countries for over 70 years, that CFU count has, to the knowledge of most of the scientific community, is not based upon any publicly available scientific laboratory testing. Neither is the topic of aggregation of ≤20 CFUs being addressed. This statement's importance is that what bacterium, virion, fungi, or spore may be a pathogen to one person may not be a pathogen to another. Who is to decide, and thus open themselves up to examination, which bacterium, virion, fungi, or spore is significant? And is the acceptance of ≤ 20 CFUs a single potential pathogen, or is ≤ 20 CFUs a total of the various microbes grown from a culture?
Notwithstanding the lack of significant documentation that ≤20 CFUs is an appropriate level for clean HCTs, many countries and organizations recognize it as a base number from which to work. One cannot always have perfection, but to wait upon achievement is to wait for disaster. But preparation requires asking questions and being comfortable with the answers, and the solutions must have justification based upon scientific evidence. Reasoning and logic are not sufficient when it comes to hygienic HCTs.
The vision of EvSOP© is to assist in the collaborative improvement of healthcare delivery. Improvements in environmental services and infection prevention operations, patient environments and patient outcomes based upon the healthcare industry best practices results from scientific research and endeavor. To the greatest extent possible, in other non-healthcare sectors, implementation of environmental services and infection prevention practices will have a direct benefit to them. EvSOP© promotes a professional mindset for continuous readiness and adaptations to meet management, staff, and customer needs and expectations.
What is the EvSOP© involvement in all of this?
In an effort toward the fulfillment of the EvSOP© vision, EvSOP© took upon itself the task of reviewing what HCT standards or certifications are available for HCT laundries to explore and incorporate into their facility, specifically testing protocols. Healthcare laundries are not required to be accredited or certified unless specified by contract with their customers.
Two bodies are the most predominant in the U.S. and Canada. Listed alphabetically to avoid the appearance of preference, they are the Healthcare Laundry Accreditation Council (HLAC) and the Textile Rental Services Association of America (TRSA). Each organization’s inspection and approval covers three years and may conduct unannounced inspections as needed. Both HLAC and TRSA offer voluntary microbiological testing for an additional cost and as requested by their customers. HLAC provides its HLAC Process Monitoring Toolkit, and TRSA provides its Biological Testing process. Both organizations permit laundries to conduct their testing – except for microbial load testing – according to parameters established by each organization.
In addition to the two organizations above, Hohenstein USA, an affiliate of Bönnigheim, Baden-Württemberg, Germany based Hohenstein Institute is currently developing a standard for use in the U.S. Its content reflects the statements of the parent standard. Hohenstein administers compliance with the RAL Quality Certification Mark 992/2 German Certification Association for Professional Textile Services certification requirements. This organization is building upon the existing accreditation and certification standards, and increasing both the incidence and intensity of microbial testing and conducting such testing themselves, rather than leave it up to the laundry operators.
EvSOP© has also conducted in-depth studies of two additional healthcare laundry standards programs: United Kingdom Department of Health and the Health Technical Memorandum HTM 01-04 Decontamination of Linen for Health and Social Care, Australian/New Zealand Standard Joint Technical Committee TX/16, Laundry Practice AS/NZ 4146-2000, and seeking information on Japanese healthcare laundry standards.
In the near future, EvSOP© will be publishing a whitepaper that compares the five organizations mentioned above and in the crosswalk by Sehulster. In an unbiased and non-endorsing manner, the whitepaper will enable IPs and others interested in comparing the five in organizations. EvSOP© hopes that this resource will benefit IPs asking themselves or being asked by others about laundry accreditation and certification. The whitepaper may also encourage IPs to enter meaningful discussions with their laundry contractors about accreditation and certification. Hopefully, they will provide information that will help IPs navigate the complexities of healthcare laundry operations and ensure that their laundry contractor continues to give HCTs that contribute toward the quality patient outcomes everyone desires.