Presentation on theme: "The 2011 HLAC Standards and Laundry Issues in Health Care"— Presentation transcript:
1 The 2011 HLAC Standards and Laundry Issues in Health Care Lynne Sehulster, PhD, M(ASCP)Division of Healthcare Quality PromotionCenters for Disease Control and PreventionJune 6, 2011
2 Disclaimer / Disclosures The findings and conclusions in this presentation are those of the author and her information resources and do not necessarily represent any determination or policy of the Centers for Disease Control and Prevention (CDC). The author is an employee of the Federal government (DHHS) and has no commercial affiliations or conflicts of interest to disclose. Any products mentioned or discussed in this lecture are for identification purposes only and does not constitute an endorsement by the Federal government.
3 Today’s Topics Introduction to CDC 2011 HLAC Standards What’s new and improvedGeneral topics addressedUpcoming issues in healthcare laundryImplications of the 2009 Rhizopus outbreakDo we stay with Hygienically Clean as the standard?Evidence-based information guides practice
4 Introduction to the Centers for Disease Control and Prevention (CDC)
5 Centers for Disease Control and Prevention (CDC) Federal government agency with the Dept. of Health and Human Services (DHHS)Only Federal government agency based outside of Washington, DCCDC is not a regulatory agencyPublic health epidemiology, public health applications, outbreak investigations, guidelines6 public health program OfficesOffice of Infectious Diseases8 National Centers, 1 National Institute (NIOSH)National Center for Emerging and Zoonotic Infectious Diseases
6 Division of Healthcare Quality Promotion DHQP’s mission: Protect patients, protect health-care personnel, and promote safety, quality, and value in the health-care delivery system“Winnable battle:” Healthcare-associated infectionsCollaborate with Federal government partnersFDA, EPA, CMS, USDA, AHQRMajor products:Healthcare guidelines produced under auspices of the Healthcare Infection Control Advisory Committee (HICPAC)National Healthcare Safety Network (NHSN)Research: outbreak investigations, surveillance trend analyses, laboratory support, Epi Center program for applied research
7 CDC / HICPAC Guidelines: Laundry and Bedding From the “Guidelines for Environmental Infection Control in Health-Care Facilities” (2003):Epidemiology and General Aspects of Infection ControlCollecting, Transporting, and Sorting Contaminated Textiles and FabricsParameters of the Laundry ProcessSpecial Laundry SituationsSurgical Gowns, Drapes, and Disposable FabricsAntimicrobial-Impregnated Articles and Consumer Items Bearing Antimicrobial LabelingStandard Mattresses, Pillows, and Air-Fluidized Beds
8 Laundry and Infectious Diseases Textiles contaminated with body substances can contain large numbers of microorganisms (106 – 108 cfu/100 cm2 fabric)Few reports in the literature link laundry to disease transmission when proper procedures are followedAnnual estimates for volume of laundry processed in U.S. health care: 5 billion lbs. (1980s, early 1990s estimate; now?)Continue current infection prevention practices
9 Current Healthcare Laundry Standard in the U.S. Standard: Hygienically cleanNot quantified for microorganisms, but assume textiles are generally rendered free of vegetative pathogensThrough a combination of soil removal, pathogen removal, pathogen inactivation, contaminated textiles are rendered hygienically cleanCarries negligible risk to healthcare workers and patients, providing that the clean textiles are not inadvertently contaminated before use
10 Main Steps of Healthcare Laundry Processing Collection of soiled textiles at point of useTransport to laundryWash cycle:Flush, main wash, bleaching, rinsing, souringDried and pressedPackaged, loaded into cartsDelivery back to the hospital
11 Laundry OperationsIf using hot water washing, water temperature >71° C (>160° F) is neededSome healthcare facilities may not have access to water at this temperatureChlorine bleach (50 – 150 ppm) is effective laundry additive, especially in hot waterOne of the rinses includes a mild acid (sour) to neutralize residual alkalinity from the washHelps to inactivate microorganismsReduces risk of skin reaction to alkali
12 Alternatives to Hot-water Laundry In-house laundries consume an average of 50% - 70% of the facility’s hot water (10% - 15% of the total energy used)Water temperature may be regulatedLower temperature wash cycles can be used with appropriate detergents and laundry additivesNew detergents and processes (e.g., oxidative products) need study
13 Laundry Transport / Storage Separate clean textiles from contaminated textiles when transporting in a vehiclePhysical barriers and/or space separationClean, unwrapped textiles can be stored in a clean location for short periods of timeUnwrapped textiles should be stored so to prevent inadvertent contamination by soil or body substancesThis is the part of the overall process that is most vulnerable to outside contamination
14 The Healthcare Laundry Accreditation Council (HLAC) 2011 HLAC Standard
16 HLAC AccreditationHLAC Standard developed from both laundry operations and infection prevention expertiseInspection process assesses compliance with the StandardAccreditation is voluntaryRenewal every 3 years is necessary to maintain accreditationHealthcare professionals increasingly aware of this accreditation program
17 Important Terminology Interpretive Guidance Preamble: This portion of the 2011 Standard is more comprehensive and informative compared to the Introduction and Background in the 2006 Standard:IntroductionStates the purpose of the Standards: minimum acceptable healthcare laundry practicesImportant TerminologyDefines Universal Precautions; identifies key participants – provider, customer, end user, inspectorInterpretive GuidanceDefines the scoring level associated with each statement’s verb – must, shall, should, mayDisclaimerFocuses on and clarifies the role of the inspector
18 Standards: This portion of the 2011 Standard is expanded extensively in an outline format, with a step-by-step, systematic approach for processing healthcare textiles in an efficient and safe environment to produce a hygienically clean textile product for patient care.Content ImprovementsFormatEach Standard statement has a unique number and addresses a single point, not multiple items which previously created scoring problemsContentComprehensive and detailed; addresses laundry processes, equipment, functional separation, quality assurance, worker safety, working environmental issues; minor reorganization of topics in Parts I and II; the new Standards raise the bar for laundry processes and product for healthcare textile reprocessingVerbsGreater clarification – scorable statements are clearly identified, and “must” statements are presented in bold-face typeCitationsScorable statements include citations to support the statement where available, including government regulations, professional association standards, and peer-reviewed literature evidenceMessage: Compliance with the new 2011 HLAC Standards will result in patient-focused infection prevention, enhanced infection control and patient safety through the production of a hygienically clean textile product. This benefits you – the provider, your customer, but most importantly the patients in your customer’s healthcare facility!
19 Expansion Example 2011 Standard: 2006 Standard: 3. Contingency Planning3.1. Contingency PlanningContingency planning shall provide for uninterrupted operations and services in the event of any occurrence potentially leading to serious disruption of the provider’s operations. Such disruption includes, but is not limited to, loss of utilities, medical emergencies, natural and/or man-made disasters, fire, inclement weather, work stoppage, or major accidents.The contingency plan shall include the following components:Plant and transportation contingency protocol,Call chain,A list of backup laundry facilities, andA backup source of textiles, if needed.2006 Standard:3. Contingency Planning3.1 Contingency planning provides for uninterrupted operations and services in the event of any occurrence potentially leading to serious disruption of facility operations. Such disruption may include, but is not limited to loss of utilities, medical emergencies, natural and/or man-made disasters, fire, inclement weather, work stoppage, or major accidents. The contingency plan shall include the following components: plant and transportation contingency protocol, call chain, and a list of back-up facilities.
20 Key Concepts in Quality for Healthcare Textiles Functional separationPrimarily accomplished via structural design and ventilation specificationsConceptually also can include work practices to keep clean textiles separate from soiled textilesHygienically clean textilesContact with clean surfaces at minimumDisinfected surfaces may be indicated
21 Part I. Basic Elements 1. Textile Control Procedures Textile Specifications Textile Maintenance Provider Inventory Management2. Laundry FacilitiesPhysical Design, Ventilation, Fixtures, Signage No cardboard allowed in storage areas, staging area addressed, storage climate statement simplified Physical Plant and Equipment Maintenance Work practices when using conventional washer extractorsManagement of Foreign Items and Regulated Wastes Expansion of sharps policy (see also Part II) Hazardous materials and pharmaceutical waste management Piped Air, Water, Wastewater, and Chemicals Management Comply with local regulations, DHS CSAT: hazardous chemicals
22 Part I. Basic Elements3. Contingency Planning Contingency Planning Plant Contingency Protocol Contingency Call Chain Backup Facility Agreements 4. Laundry Equipment Documentation Installation and Utilities Connections Equipment Operation Preventive Maintenance Equipment Calibrations Repairs Recordkeeping for New, Existing, and/or Used Equipment
23 Part I. Basic ElementsLaundry Personnel Personnel Qualifications Personnel General Responsibilities Defines the roles of supervisors/managers, employees Health and Hygiene Employee Safety OSHA lock out/tag out requirement; expands safety beyond the OSHA bloodborne pathogen standard to include chemical safety and mechanical hazard issues Personal Protective Equipment (PPE) and Attire No artificial nails Occupational Safety and Health Elements Introduces concept of HBV serologic testing as part of post exposure management (a “May” statement) Hazardous material safety plan/policy Training and Educational Programs Hazardous material safety training
24 Part I. Basic Elements6. Laundry Customers Provider Policy Contact Visitation Customer Complaints 7. Quality Assessment General Rationale Quality Control Quality Assurance Process Monitoring Accounting
25 Part II. The Textile Processing Cycle 1. Handling, Collection and Transportation of Soiled Healthcare Textiles Universal Precautions Handling and Collection Soiled Textile Containment for Laundries Not Using Universal Precautions (more detailed compared to 2006 material) Transportation Carts Used for Soiled Textiles 2. Sorting Soiled Sorting Area Universal Precautions Sorting Soiled Textiles Foreign Object Policies Expansion to include devices (instruments), patients’ personal items in addition to sharps
26 Part II. The Textile Processing Cycle Washing and Extraction Equipment Washing ExtractionDrying (not new, but given its own subpart) Equipment Drying5. Finishing Ironing Equipment Folding and Stacking Packaging (moved into this subpart) Reprocessing Requirements
27 Part II. The Textile Processing Cycle Storage Rationale Storage Areas Storage Options Reprocessing Requirements7. Delivery of Cleaned Healthcare Textiles Rationale Delivery Methods Cart Function and Cleanliness Vehicle Considerations Occupational safety for vehicle drivers
28 Part III. Surgical Pack Assembly Room Standards Note: Part III does not address sterilization of the assembled packs1. Physical Facilities: Surgical Pack Assembly Area/Room General Rationale Floors, Walls, Ceilings and Vents Separation of Work Areas Ventilation Requirements for Proper Air Flow and Climate Control Storage Area for Clean Textile Packs2. Surgical Pack Assembly Room Entry and Admission Policies Location of Hand Hygiene Stations
29 Part III. Surgical Pack Assembly Room Standards 3. Surgical Textile Assembly Process Carts Used to Move Clean Surgical Textiles to the Pack Assembly Room Inspection of Clean Surgical Textiles Prior to Pack Assembly Maintenance of Surgical Textiles 4. Preparation and Wrapping of Surgical Textiles General Rationale Folding Surgical Textile Pack Assembly Wrapping and Packaging Labeling/Identification of Packs
30 Part III. Surgical Pack Assembly Room Standards 5. Storage and Transportation of Surgical Textile Packs Storage of Surgical Textile Packs Transportation of Surgical Textile Packs 6. Surgical Textile Pack Assembly Room Personnel Qualifications Training and Competency Health and Personal Hygiene Attire and Personal Protective Equipment (PPE)
31 HLAC Standard 2011: Appendices Appendices in the 2011 HLAC Standards: Inform, reference, and acknowledge the many contributions to this first, major revision to the HLAC StandardsAppendix A: Glossary/TerminologyProvides definitions for terms used in the StandardAppendix B: AbbreviationsSpells out and defines the abbreviationsAppendix C: Ventilation Parameters for Healthcare Laundry AreasProvides ventilation specifications in hospital laundryAppendix D: CFR Text for FDA DevicesProvides the device storage and handling text from FDA in the Code of Federal RegulationsAppendix E: ReferencesBibliography of the references used in the StandardAppendix F: AcknowledgementsOutside reviewers and experts providing comment during the revision processAppendix G: HLAC Board of Directors2009, 2010, and 2011 HLAC Boards participated in the review and revision process
32 Will “Hygienically Clean” Remain the Standard for Healthcare Textile Reprocessing?
34 Mucormycetes Mucormycetes are ubiquitous molds 23 pathogenic species; Genus Rhizopus causes half of all infectionsRhizopus oryzae most common; genetic variety observed within speciesMucormycosis:Skin is common site of infectionInvasive mold: fatality rate highly variable (ranges from 10% - 94%)
38 Additional Results Patient specimens: Environmental cultures: Type: culture (1), tissue block (3)All four (+) for Rhizopus oryzaeEnvironmental cultures:Hospital A: 13/13 cultures (+) for Rhizopus oryzaeLaundry facility: No Rhizopus oryzaeR. oryzae from one patient and from clean linen/cart had the same genetic subtype
40 ConclusionsHospital linens were the most likely vehicle to have brought Rhizopus in contact with the patientsGenetic subtyping of fungal isolates supported this epidemiologic hypothesisContamination of clean linens with Rhizopus happened repeatedly, but might have been intermittentHospital linens should be laundered, shipped, and stored in a manner that minimizes exposure to environmental contaminants
41 Things to ConsiderSome have called for purposeful sanitization of laundry because of the outbreakLaundering process was not implicatedSome are advocating treating textiles to leave antimicrobial chemicals as residueDo we know how safe this is for patients?EPA may consider this as a “treated article”
42 Chain of Infection (COI) Virulent pathogen:Bacteria, fungi, viruses, parasites, prionsSufficient number of pathogen:Infectious doseMode of transmission:Contact, droplet, airbornePortal of entry:Broken skin, mucous membrane, respiratory tract, ingestionSusceptible host:Age, immunity, medical conditionsOther possible links include reservoir, portal of exit42
43 What is the Evidence to Justify Purposeful Sanitization? Outbreaks of infection associated with clean healthcare textiles still a rare eventEuropeans have promoted laundry disinfectionMore active in laundry disinfection researchIs laundry disinfection a cost-effective process?
44 Why is This Significant? Hospital environmental and medical equipment surfaces rapidly become contaminatedRecent studies demonstrate that:Hands and gloves of healthcare workers readily acquire pathogens after contact with contaminated surfacesHealthcare workers can transfer these pathogens to subsequently touched patients and inanimate surfacesPatients subsequently can become colonized/infectedHospital environmental and medical equipment surfaces rapidly become contaminatedRecent studies demonstrate that:Hands and gloves of healthcare workers readily acquire pathogens after contact with contaminated surfacesHealthcare workers can transfer these pathogens to subsequently touched patients and inanimate surfacesPatients subsequently become colonized/infectedThese findings have led to an increased focus on the importance of hand hygiene, cleaning and disinfecting hospital surfaces and medical equipment44
45 Basic Strategy Elements for Preventing and Eliminating Contamination of Environmental Surfaces Prevent environmental surface contaminationHandwashing / hand hygieneUse of barrier coverings on clinical touch surfacesResponsible use of gloves, personal protective equipment (PPE)Clean–to–dirty work flow whenever practicalAvoid dirty-to-clean work flow as much as practicalRemove environmental surface contaminationCleaningInactivate environmental surface contaminationDisinfection for inanimate surfacesAntisepsis for living tissue
46 HACCP for Laundry Hazard Analysis and Critical Control Point Similar to the ICRA currently used in hospital infection prevention programAssess all aspects of the laundering process to identify opportunities for contamination to occurOwner/operators become proactive in infection prevention
47 Textile Management and C. difficile Contamination Consider cohorting symptomatic patients/ residents’ clothing to wash separately from clothing of healthy residentsDuring a wash cycle, do not mingle used cleaning cloths in with clothing from healthy residentsHigh numbers of spores may remain on the cloths if used with a non-sporicidal disinfectantUse of sporicidal disinfectant will reduce the viable spore numberFrom: Carbone HL, et al Decennial Infection Prevention and Epidemiology Conference, poster #160
48 Making the Case for Laundry Standards Revisions Demonstrate added value for product quality, patient safety, healthcare worker safetyResearch new developments using validated methods to assess antimicrobial propertiesMake the case for change to your healthcare customersPublish in peer-reviewed journalsContinue reporting new developments in industry publications, but explore publication venues typically used by nurses, EVS directors, hospital epidemiologists
49 Acknowledgments Thanks to: Nancy Bjerke, RN, BSN, MPH, CIC and Linda Fairbanks for their leadership in the revision process for the HLAC StandardThe members of the HLAC Standards Committee and the members of the HLAC Board of Directors for deliberation and debateJonathan Duffy, MD, MPH for sharing the poster presented at the Decennial Meeting, 2010
50 Thank You! Division of Healthcare Quality Promotion Centers for Disease Control and Prevention“Protect patients, protect health-care personnel, and promote safety, quality, and value in the health-care delivery system”
Your consent to our cookies if you continue to use this website.